- Penumbra, Inc. v. Rapidpulse, Inc.All claims unpatentablePTAB · Sep 6, 2023 · IPR2022-00608 · APJ Jamie T Wisz · IPR · Final written decision
Claims 1–21 are unpatentable: claims 1–14, 17–19, and 21 as obvious over Teigen and Grey; claims 15–16 over Teigen, Grey, and Yang; and claim 20 over Teigen, Grey, and Matteo.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. PERSON OF ORDINARY SKILL IN THE ART In determining the level of skill in the art, we consider the type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962 (Fed. Cir. 1986). The level of ordinary skill in the art is “a prism or lens through which . . . the Board views the prior art and claimed invention” to prevent hindsight bias. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“as adopted by the Board in the Institution Decision. The ’253 patent explicitly defines this term, stating: The term “forward flow” is used herein to define an amount of liquid in the lumen 662 that exits the distal end 664 in a distal direction. Forward flow is defined as greater than 6 microliters of fluid (approximately 1 mm of catheter length of ID 0.071″=5.7 μL). Ex. 1001, 38:18–23 (emphasis added). Moreover, in discussing problems with the prior art systems, the ’253 patent states that “[w]hen positive pressure exists at the distal end of the lumen, liquid from inside the lumen exits out from the distal end of the catheter in a distal direction. This is referred to as forward flow.” Id. at 3:8–11. In the ’253 patent, the patentee acted as its own lexicographer as evidenced by usage of language such as “is used herein to define,” “is defined,” and “is referred to as,” to discuss “forward flow.” We find that the definition of “forward flow” in the ’253 patent specification would provide a person of ordinary skill with “reasonable clarity, deliberateness, and precision” as to the meaning of the term. See Paulsen, 30 F.3d at 1480; see also Ex. 1034 ¶¶ 13–14. Thus, we construe the term, “forward flow,” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters.” We disagree with Patent Owner’s contention that our construction imports limitations from a single embodiment into the claims. As explained above, the ’253 patent clearly defines the term “forward flow” and this definition is not limited to a single embodiment. In fact, the ’253 patent indicates that, while “[f]orward flow is defined as greater than 6 microliters of fluid . . . [l]ess forward flow is also included in this definition.” Ex. 1001, 38:21–24. The ’253 patent specifies that “the amount of forward flow can be restricted to no greater than 2 microliters or, in a particularly beneficial embodiment, forward flow is approximately zero microliters.” Id. at 38:24– 29. This language indicates that our construction encompasses multiple embodiments from the ’253 patent. We also disagree with Patent’s Owner’s proposed construction of “forward flow” because it is not supported by the ’253 patent specification. Patent Owner contends that “there is ‘no forward flow’ until the full extent of the distal portion” exits the distal end and thus forward flow is prevented when only less than “the full extent of the distal portion” exits the distal end. PO Resp. 9 (emphasis omitted). To adopt Patent Owner’s proposed construction, we would have to essentially ignore the ’253 patent’s express definition of this term. Further, there is no support in the ’253 patent specification for “full extent” or “fully exiting.” We also agree with Petitioner that Patent Owner’s construction effectively eliminates the concept of preventing forward flow because, as Patent Owner acknowledges, it could allow, for example, 20 milliliters of fluid to exit the catheter, which could displace the thrombus into the patient’s vasculature, a problem that the ’253 patent seeks to avoid. See PO Resp. 10–12 (citing Ex. 2014 ¶¶ 48–51); Pet. Reply 8–9 (citing Ex. 1034 ¶¶ 14–15).” slip op. at 13
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“As discussed above, we construe “forward flow” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters.” Thus, for the ’011 provisional to provide support for this limitation, the provisional must demonstrate that the inventors had possession of preventing greater than 6 microliters of fluid out of the distal end of the catheter. While Patent Owner points to disclosures from the ’011 provisional application that describe the desire to have “a minimal amount of momentum transfer from the fluid column to the stuck clot to unstick the clot sufficiently” and “[t]he exiting movement of fluid [being] limited to a specific volume and/or pressure and is automatically and precisely controlled” to prevent the “possibility of overshooting,” these disclosures would not convey to one of ordinary skill in the art that the inventors were in possession of a device that limited forward flow to no greater than 6 microliters of fluid. PO Resp. 35 (citing Ex. 1003 ¶¶ 15, 16, 138). Patent Owner also contends that the ’011 provisional application provides “multiple examples of liquid flow exiting the distal end of the catheter such that no forward flow occurs, such as 1 microliter or 0.5 mm of column shift.” PO Resp. 36–37 (citing Ex. 1003 ¶ 91). However, the disclosure cited by Patent Owner provides ranges of liquid flow of “approximately 0.001 ml to approximately 1.0 ml, in particular, approximately 0.1 ml to approximately 0.5 ml” and exemplary length of shift distances of “approximately 0.5 mm to approximately 30 mm, in particular, approximately 0.5 mm to approximately 15 mm.” Ex. 1003 ¶ 91. There is nothing in the ’011 provisional application that specifically directs the person of ordinary skill to the portions of these ranges that fall within the ’253 patent’s definition of “forward flow” (i.e., no greater than 6 microliters of fluid). In fact, the majority of the cited ranges are greater than 6 microliters, going all the way up to 1,000 microliters, such that there would be forward flow in these examples. See Ex. 1034 ¶ 25; Purdue Pharma, 230 F.3d at 1326–27 (“[O]ne cannot disclose a forest in the original application, and then later pick a tree out of the forest and say here is my invention. In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree must be in the originally filed disclosure.”); Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996). Further, we note that the ’253 patent differentiates between embodiments that allow forward flow and embodiments in which no forward flow occurs. See Ex. 1001, 32:58–60, 37:19–22; Pet. Reply 10–11. For example, the ’253 patent describes an embodiment in which the “momentum causes a small amount of fluid to move through the distal portion of the catheter [] and create a small distal movement of the clot.” Ex. 1001, 32:47– 51. This same embodiment is disclosed in the ’011 provisional application. Compare Ex. 1003 ¶ 126 with Ex. 1001, 32:16–60. The ’253 patent describes this disclosure as an “exemplary embodiment” in which the “flow of fluid forward . . . is intentional, which is in contrast to other exemplary embodiments herein where substantially no forward flow occurs.” Ex. 1001, 32:57–60; see also, id. at 37:19–22 (“Turning now to embodiments . . . without the forward flow”).8 The ’011 provisional application does not include the subsequent embodiments from the ’253 patent that are described as being “without the forward flow.” See Ex. 1005 ¶ 68; Ex. 1034 ¶¶ 22–23. This further demonstrates that the ’011 provisional application does not support the limitation of “prevent[ing] forward flow.” We also note that the ’011 provisional application does not contain adequate support for the limitation of “substantially prevent[ing] forward flow” even under Patent Owner’s proposed construction. While the ’011 provisional discloses “controlling the distal movement of the fluid column” (Ex. 1003 ¶¶ 15, 16), this does not support Patent Owner’s assertion that the ’011 provisional teaches that “the distal portion of the fluid column is substantially prevented from fully exiting the distal end.” PO Resp. 35–36. For example, as discussed above, the ’011 provisional application discloses permitting distal flow of up to 1,000 microliters, which would likely exceed the amount that could be characterized as the full distal portion. Ex. 1003 ¶ 91; Ex. 1034 ¶ 25. Thus, we find that the ’011 provisional application does not “clearly allow persons of ordinary skill in the art to recognize that [the inventors] invented what is claimed.” In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989); Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 8 Patent Owner contends that the statement in the ’253 patent regarding the “exemplary embodiment” of “forward flow” is referring to an embodiment in which the volume of the liquid drawn out from the lumen of the catheter is “approximately 0.2 ml.” PO Resp. 40–41 (citing Ex. 1001, 32:35–36; Ex. 1003 ¶ 126; Ex. 2014 ¶ 99). Even if this is correct, the ’011 provisional application does not include the embodiments that the ’253 patent specifically characterizes as being “without the forward flow.” Pet. Reply 10–11; Ex. 1005 ¶ 68; Ex. 1034 ¶ 22–25.” slip op. at 20
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner
“Based on the above, we determine that, for prior-art determinations under AIA § 102, “there is no need to evaluate whether any claim of [a reference] patent document is actually entitled to priority or benefit under 35 U.S.C. 119, 120.” MPEP § 2154.01(b) (emphasis added). Rather, under the AIA, a reference patent document need only meet the “ministerial requirements” of §§ 119 and 120, and the provisional or other earlier application(s) to which the reference patent document claims a right of priority must “describe[] the subject matter” relied upon in the reference patent document as prior art. 35 U.S.C. § 102(d)(2). Patent Owner has not contested that Teigen meets the procedural requirements for claiming priority to the ’712 patent or the ’095 PCT application. Teigen also appears to meet the ministerial requirements for claiming priority to the provisional applications because it properly claims the benefit of these applications, the ’095 PCT application was filed co-pending with the provisional applications, and the applications share common inventors. Ex. 1007, codes (22), (60), (63), (72); Ex.1008, 2; Ex. 1009, 2; Ex. 2005, codes (22), (30), (72). Patent Owner does not dispute that Teigen meets the “ministerial requirements” of § 119. Because we find that the Dynamic Drinkware analysis does not apply here, we agree with Petitioner and Patent Owner, that we need not reach the issue of whether a claim from Teigen is supported by either Teigen provisional application. PO Sur-Reply 8; Pet. Reply 12–13.” slip op. at 30
Patent outcomesUS 10,722,253 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 10,722,253 - PTAB · Apr 18, 2023 · IPR2022-00123 · APJ Zhenyu Yang · IPR · Final written decision
The Board cancelled original claim 1 and denied substitute claim 2 for lack of written-description support; it did not reach the obviousness or enablement grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“ordinary skill is inappropriate because it “requires qualifications that exclude even the sole inventor of the ’190 Patent, Dr. Edward Neuwelt.” MTA Opp. 1. According to Petitioner, Dr. Neuwelt is “a neurosurgeon,” not a pediatric oncologist, and lacks the requisite “at least 2 years” experience in platinum-based therapies. Id. (citing Ex. 1003, 18; Ex. 1038, 98:9–17, 100:15–101, 4). We agree with Petitioner. It is well settled that inventors are typically persons skilled in the field of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). Petitioner presents persuasive evidence to show that under Patent Owner’s proposed definition of the level of ordinary skill, Dr. Neuwelt, the sole inventor, would not qualify as an ordinarily skilled artisan, because he is not a pediatric oncologist, even though he is considered “one of the world leading experts on this compound [STS] and otoprotection” and “an expert in the area of [STS] as a . . . drug to use in children with medulloblastoma.” Ex. 1038, 98:9–17, 99:17–18, 101:18–102:13.” slip op. at 10
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Paragraph 102 of Dr. Rassekh’s Declaration, however, does not support Patent Owner’s assertion. Instead, Dr. Rassekh testifies that [t]he stratum of previous craniospinal radiation therapy contained 8 participants: 2 of the 4 (50%) participants receiving STS had hearing loss compared to 4 of the 4 (100%) participants not receiving STS, and none of the hearing loss assessments were changed at the 1 year follow up period. (Ex. 1001 at 20: 28-32, 47-50.) Ex. 2024 ¶ 102. Dr. Rassekh offers no opinion on how many osteosarcoma patients with prior cranial irradiation and how many medulloblastoma patients with prior cranial irradiation had hearing loss.” slip op. at 20
- 112 supportMotion to amend, deniedDenied
“In sum, we find the disclosures of the ’243 application that Patent Owner relies on do not provide sufficient written-description support for the ototoxicity efficacy limitation.” slip op. at 21
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not reached
“F. Petitioner’s Asserted Unpatentability Grounds In light of our determination above that Patent Owner has not shown sufficient written-description support for proposed substitute claim 2 in the ’243 application, we do not reach the grounds of unpatentability set forth in Petitioner’s Opposition. See Revised MTA Opp. 17–25 (alleging non-enablement and obviousness).” slip op. at 26
§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,596,190 - Penumbra, Inc. v. Rapidpulse, Inc.All claims unpatentablePTAB · Mar 10, 2023 · IPR2021-01466 · APJ Jamie T Wisz · IPR · Final written decision
Claims 1–18 are unpatentable under §103: claims 1–12, 15, 16, and 18 over Teigen and Grey; claims 13–14 over Teigen, Grey, and Yang; claim 17 over Teigen, Grey, and Matteo.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Based on our consideration of the full record, we find that, overall, Patent Owner’s definition is more specifically tailored to the claimed subject matter of the ’883 patent. We also find that, a person with a biomedical engineering degree could have the required background in fluid mechanics. See Ex. 1031, 45:21–46:7. Therefore, we find that a person of ordinary skill in the art would have a B.S. in mechanical or biomedical engineering with at least three years of experience in designing systems for minimally invasive intravascular procedures for treating occluded vessels or the equivalent and in consultation with medical professionals such as interventional neurosurgeons. Although we agree with, and have primarily adopted Patent Owner’s definition for an ordinarily skilled artisan in this proceeding, our analysis and conclusions herein would not change even under Petitioner’s definition. The parties also do not indicate that the outcome would differ based on the definition of the person of ordinary skill in the art. See Pet. 15; PO Resp. 6; Pet. Reply 1.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“as adopted by the Board in the Institution Decision. The ’883 patent explicitly defines this term, stating: The term “forward flow” is used herein to define an amount of liquid in the lumen 662 that exits the distal end 664 in a distal direction. Forward flow is defined as greater than 6 microliters of fluid (approximately 1 mm of catheter length of ID 0.071″=5.7 μL). Ex. 1001, 36:18–23 (emphasis added). Moreover, in discussing problems with the prior art systems, the ’883 patent states that “[w]hen positive pressure exists at the distal end of the lumen, liquid from inside the lumen exits out from the distal end of the catheter in a distal direction. This is referred to as forward flow.” Id. at 2:62–65. In the ’883 patent, the patentee acted as its own lexicographer as evidenced by usage of language such as “is used herein to define,” “is defined,” and “is referred to as,” to discuss “forward flow.” We find that the definition of “forward flow” in the ’883 patent specification would provide a person of ordinary skill with “reasonable clarity, deliberateness, and precision” as to the meaning of the term. See Paulsen, 30 F.3d at 1480; see also Ex. 1030 ¶¶ 13–14; Ex. 2001 ¶¶ 53, 62. Thus, we construe the term, “forward flow,” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters.”” slip op. at 14
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“As discussed above, we construed “forward flow” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters.” Thus, for the ’011 provisional to provide support for this limitation, the provisional must demonstrate that the inventors had possession of preventing greater than 6 microliters of fluid out of the distal end of the catheter. While Patent Owner points to disclosure from the ’011 provisional application which describes “a minimal amount of momentum transfer from the fluid column to the stuck clot to unstick the clot sufficiently” and “[t]he exiting movement of fluid [being] limited to a specific volume and/or pressure and is automatically and precisely controlled” to prevent the “possibility of overshooting,” it would not convey to one of ordinary skill in the art that the inventors were in possession of a device that limited forward flow to no greater than 6 microliters of fluid. PO Resp. 33 (citing Ex. 1003 ¶¶ 16, 138). Patent Owner also contends that the ’011 provisional application provides “multiple examples of liquid flow exiting the distal end of the catheter such that no forward flow occurs, such as 1 microliter or 0.5 mm of column shift.” PO Resp. 34 (citing Ex. 1003 ¶ 91). However, the disclosure cited by Patent Owner provides ranges of liquid flow of “approximately 0.001 ml to approximately 1.0 ml, in particular, approximately 0.1 ml to approximately 0.5 ml” and exemplary length of shift distances of “approximately 0.5 mm to approximately 30 mm, in particular, approximately 0.5 mm to approximately 15 mm.” Ex. 1003 ¶ 91. There is nothing in the disclosure of the ’011 provisional application that specifically directs the person of ordinary skill to the portions of these ranges which fall within the ’883 patent’s definition of no “forward flow” (i.e., no greater than 6 microliters of fluid). In fact, the majority of the cited ranges are greater than 6 microliters, going all the way up to 1,000 microliters, such that there would be forward flow in these examples. See Ex. 1030 ¶ 29; Purdue Pharma, 230 F.3d at 1326–27 (“[O]ne cannot disclose a forest in the original application, and then later pick a tree out of the forest and say here is my invention. In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree must be in the originally filed disclosure.”); Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996).” slip op. at 21
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner
“AIA § 102 draws a distinction between actually being entitled to a right of priority to, or the benefit of, a prior-filed application according to the definition of “effective filing date” of a claimed invention in AIA 35 U.S.C. § 100(i)(1)(B), and merely being entitled to claim a right of priority to, or the benefit of, a prior-filed application for prior-art purposes according to the use of “effectively filed” in AIA 35 U.S.C. § 102(d). See 35 U.S.C. §§ 100(i)(1)(B), 102(a)(2), 102(d)(2); MPEP § 2154.01(b). USPTO guidance also indicates that AIA § 102 prior-art reference effective-filing-date determinations differ from pre-AIA law. For example, a 2018 Memorandum to the Patent Examining Corps states, in the context of prior-art determinations, that “[t]he requirement that one of the claims in the patent [document] . . . be supported by the written description of the provisional application in compliance with pre-AIA 35 U.S.C. § 112, first paragraph (or AIA 35 U.S.C. § 112(a)), is not applicable when examining an application subject to the first inventor to file provisions of the AIA.” Robert W. Bahr, Memorandum re: Critical Reference Date Under pre-AIA 35 U.S.C. §102(e) (Apr. 5, 2018), available at http://www.uspto.gov/sites/ default/files/documents/dynamic_memo_05apr2018_0.pdf (emphasis added) (citing Dynamic Drinkware, 800 F.3d at 1381 n.2; 157 Cong. Rec. 3423 (2011) (explaining the distinction between being entitled to claim priority or benefit in AIA 35 U.S.C. § 102(d) and actually being entitled to priority or benefit under 35 U.S.C. § 119, 120, or 365)). This Memorandum further indicates: The date subject matter was “effectively filed” under AIA 35 U.S.C. § 102(d) for purposes of considering a U.S. patent, a U.S. patent application publication, or an international application publication as prior art under AIA 35 U.S.C. § 102(a)(2) is discussed in MPEP § 2154.01(b), and is not affected by Dynamic Drinkware or [Amgen v. Sanofi, 872 F.3d 1367, 1380 (Fed. Cir. 2017)] and is not being modified by this memorandum. Id. at 2. MPEP § 2154.01(b) explicitly states, as a result of the distinction discussed above, in application of the AIA version of § 102, “the question of whether a patent or published application is actually entitled to priority or benefit with respect to any of its claims is not at issue in determining the date the patent or published application was ‘effectively filed’ for prior art purposes.” MPEP § 2154.01(b) (emphases added).” slip op. at 31
Patent outcomesUS 10,531,883 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 10,531,883 - 3M Company v. Bay Materials, LLCInstitutedPTAB · Jan 18, 2023 · IPR2022-01215 · APJ Grace Karaffa Obermann · IPR · Institution
The Board instituted inter partes review of claims 1–4, 7, 11–14, 18, and 31 on all asserted grounds, finding at least one claim sufficiently shown anticipated by Yu.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“The Petition includes detailed arguments that map the limitations of the challenged claims to specific disclosures in Yu (Sample 1). Id. at 50–62. The Petition also maps adequately the limitations of the challenged claims to specific disclosures in Stewart (Example 2). Id. at 62–66. For example, Petitioner shows sufficiently that Yu (Example 1) coextrudes “a multilayered polymeric film,” that is, a “sheet,” arranged in the hard-soft-hard-soft-hard, five-layer configuration required by claim 11. Pet. 50–51; Ex. 1002 ¶¶ 124, 126–128; Ex. 1012 ¶¶ 63, 78, 92. Petitioner also shows sufficiently that the hard layers in that configuration of Yu (Example 1) are “hard” and the hard layers are “hard” within the meaning of claim 11. Pet. 53; Ex. 1002 ¶ 131; Ex. 1012 ¶ 78. In other words, Petitioner shows sufficiently, on this record, that Yu (Example 1) anticipates claim 11. Based on the information presented, we find that Petitioner shows sufficiently, for purposes of trial institution, that at least one challenged claim of the ’263 patent is anticipated by Yu (Sample 1).” slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“That prior art disclosure of elastomeric materials for use as the outer layers in an unclaimed and disfavored soft-hard-soft layer configuration does not convey, with reasonable clarity, that the inventors had possession of the claimed subject matter, in which the elastomeric material forms the inner layer of a polymeric sheet in a hard-soft-hard layer configuration. See id. ¶¶ 7, 33–35, 109–110. Even if the hardness limitation of the challenged claims would have been obvious from the relied-upon disclosure of the ’176 application (Ex. 2001 ¶ 109), that circumstance is insufficient to establish written description support. “Entitlement to a filing date does not extend to subject matter which is not disclosed, but would be obvious over what is expressly disclosed.” PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306 (Fed. Cir. 2008) (quotations omitted); see Pet. 21 (quoting that precedent). Accordingly, we agree with Petitioner that the invention that Patent Owner seeks to protect in the ’263 patent does not appear to be “part of the invention” described in the ’176 application. Pet. 40; see Ex. 2001 ¶ 109 (describing elastomeric materials, having the specified hardness, only in the context of an unclaimed prior art soft-hard-soft embodiment). On this record, we preliminarily agree with Petitioner that the earliest effective filing date to which the ’263 patent appears to be entitled is December 18, 2019, namely, the filing date of the ’256 application, from which the ’263 patent issued. Ex. 1001, codes (21), (22). Patent Owner may contest this issue in a timely response to the Petition.” slip op. at 9
- Skill levelNot reached
“The parties disagree about whether the ordinarily skilled artisan would have had specific “experience with dental appliances or access to individuals with such experience.” Prelim. Resp. 17; see Pet. 14–15 n.1 (disagreeing with that proposition). Neither party explains why a resolution of that Stat. 284 (September 16, 2011), includes revisions to Section 102(a) that became effective on March 16, 2013. For reasons explained in this Decision, on this record it appears Petitioner is correct that the challenged claims are entitled to an effective filing date no earlier than December 18, 2019 and, therefore, the AIA provisions apply in this proceeding. See Pet. 22, 39–40; Ex. 1001, code (60). 2 WO 20010/043419 A1, published Apr. 22, 2010, with English Translation (Ex. 1015). 3 We take notice that the first and second grounds identified in the Petition assert anticipation based on the same prior art disclosure. 4 US Pub. 2004/0224283 A1, published Nov. 11, 2004 (Ex. 1008). dispute is necessary to this Decision to institute review. See, e.g., Prelim. Resp. 17 n.2 (“even under Petitioner’s proposed definition, the Petition fails to show a reasonable likelihood that any claim is unpatentable”); Pet. 14–15 & n.1 (arguing about the issue without explaining how a resolution of the dispute would change the outcome of the decision on institution). If either party believes that the difference in level of skill would have a material effect on the analysis of the patentability of the challenged claims, that issue should be specifically addressed in briefing during the trial. We will resolve that dispute only to the extent necessary in any final written decision. Based on the information presented, we find that the asserted prior art itself is sufficient to demonstrate the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“We construe terms in controversy only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). “Petitioner discusses the terms “layer A,” “layer B,” “layer C,” “layer C,” “layer B',” inner layer B,” “inner layer B',” and “inner layer D.” Pet. 15–20. Patent Owner discusses the terms “layer” and “inner.” Prelim. Resp. 19–22. Taking account of the information presented, we determine that no claim term requires express construction for purposes of deciding whether to institute review. Compare Pet. 15–20 (addressing issues of claim construction, without demonstrating that an express construction is necessary to resolve whether to institute review), with Prelim. Resp. 19–22 (same).” slip op. at 7
Claim construction§ 112 disclosurecites Phillips · GrahamPatents in suitUS 10,870,263 - Beckman Coulter, Inc. v. Sysmex Corporation And Sysmex America, Inc.All claims unpatentablePTAB · Feb 18, 2022 · IPR2020-01503 · APJ Jo-Anne M Kokoski · IPR · Final written decision
Claims 7–15 are unpatentable as obvious over Nagai and Jagtiani; the priority applications lack written-description support for the claimed electrical detection and cell-counting combination.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In the Institution Decision, we determined that Petitioner’s definition was consistent with the disclosure of the ’351 patent and the scope and content of the asserted prior art to the extent that Petitioner’s definition requires familiarity with the design and operation of automated hematology analyzers available in the market. Dec. 8 (citing Ex. 1001, 1:45–61, 15:52– 58). We also determined that Petitioner’s proposal was more reasonable than Patent Owner’s with respect to the duration of a POSA’s practical experience, whether such practical experience is in addition to or possibly as experience could be merely using hardware and/or software for an analyzer, as opposed to developing such hardware and/or software. Id. at 8–9. Neither party contends that the differences in proposals affect the outcome of this proceeding, and we find that they do not. Nonetheless, on the full record now before us, we find that our identification of the level of ordinary skill in the art in the Institution Decision, modified to state that a higher level of experience can compensate for less technical education, is supported by the ’351 patent, the prior art of record, and the opinions of Mr. Roche and Dr. Robinson (which, as discussed above, recognize that additional work experience can compensate for technical education). Thus, we find that a POSA would have had at least a Bachelor’s or Master’s degree in biologic science, biomedical engineering, and/or electrical engineering or a related field and at least five years of experience in developing hardware and/or software for hematology analyzers, and would have been familiar with the design and operation of hematology analyzers available in the market. We also find that less technical education may be compensated by a higher level of experience, or vice versa.” slip op. at 10
- Prior constructionPrior construction adoptedDecided for petitioner
“a controller programmed to,” “optical detector,” “electrical detector,” and “mono-nucleated cells and poly-nucleated cells” as recited in claim 7, and “total count of nucleated cells” as recited in claims 8 and 13. Pet. 22–29. Patent Owner responds that “[t]he District Court issued an opinion regarding claim construction on April 6, 2021,” and, “[f]or purposes of this proceeding, Patent Owner applies the District Court’s constructions.” PO Resp. 13. Patent Owner also specifically addresses the terms “controller programmed to” and “electrical detector.” Id. at 13–14. Petitioner replies that its proposed claim constructions are consistent with the District Court’s constructions. Pet. Reply 4–5. At the oral hearing, the parties confirmed that they do not dispute the District Court’s claim constructions. See Tr. 16 (Petitioner’s counsel stating that “Petitioner would request that this Board adopt these same [District Court] constructions in this IPR”), 34 (Patent Owner’s counsel agreeing that “neither side has objected to the court’s claim construction”). Based on the parties’ apparent agreement, and considering the record before us and the Report and Recommendation from the District Court (Ex. 2065), we agree with and adopt the District Court’s claim constructions. See 37 C.F.R. § 42.100(b) (“Any prior claim construction determination concerning the claim in a civil action . . . that is timely made of record in the inter partes review proceeding will be considered.”). Accordingly, we construe the terms “controller programmed to,” “electrical detector,” and “optical detector” as set forth below. slip op. at 12
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateNot shown unpatentable
“that Petitioner has established that the priority applications do not provide adequate written description support for the challenged claims. More specifically, we find that the priority applications do not reasonably convey to a POSA that the inventors were in possession of a sample analyzer that both (1) uses an electrical detector to electrically sense cells in a body fluid measurement sample, and (2) from the analysis of the cells sensed by the electrical detector, counts the number of mono-nucleated cells and poly-nucleated cells in the body fluid measurement sample as required by claim 7.” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“Based on our review of the record, we determine that Petitioner has established that a POSA would have had reason to combine the teachings of Nagai and Jagtiani to achieve the claimed subject matter. Nagai describes an electrical detector (RBC/PLT detection unit 42) that “is capable of measuring the number of red blood cells and platelets by a sheath flow-DC detection method.” Ex. 1044, 6:58–63, Fig. 5. Nagai also describes WBC detection unit 41 that produces a DIFF scattergram that, in the body fluid measuring mode, is analyzed in order to classify the white blood cells into two subclasses, namely, mono-nucleated cells and poly-nucleated cells. Id. at 5:56–58, 12:27–36. Nagai teaches that WBC detection unit 41 is “configured as an optical detection unit” that performs white blood cell classification in the body fluid measurement mode using a combination of electrical resistance and absorbed light. Id. at 5:56–58, 15:52–16:6. Jagtiani teaches a channel sensor that can detect impedance to differentiate between different types of cells in a biological sample, including differentiating between red blood cells, white blood cells, and platelets. Ex. 1045 ¶¶ 21, 25; see also id. ¶ 187 (“The channel sensor is based on impedance sensing using the Coulter principle.”). Jagtiani teaches the sensor can be configured to differentiate between and count the number of eosinophils, basophils, neutrophils, monocytes, and lymphocytes in the biological sample. Id. ¶ 25; see also id. ¶ 121 (“In some embodiments, the cell count can include a white blood differential, and can include a count of basophils, a count of eosinophils, a count of lymphocytes, a count of neutrophils, and/or a count of monocytes.”). Jagtiani further teaches that “[s]uch biological samples can include, for example, blood, serum, saliva, sweat, tears, urine, or any other biological sample or derivative suspended in a fluid.” Id. ¶ 119. In light of these teachings in Nagai and Jagtiani, we credit Mr. Roche’s testimony that Jagtiani demonstrates a known technique of detecting poly-nucleated and mono-nucleated white blood cells using an electrical detector. A POSA at the time of the invention would have been led to modify Nagai with the teaching of Jagtiani in the manner claimed to allow the body fluid measurement of Nagai to differentiate poly-nucleated and mono-nucleated blood cells (instead of measuring red blood cells alone). Such a motivation is found, for example, in Petitioner’s DxH system, which discloses use of an electrical detector in both a blood measuring mode and a fluid measuring mode. Ex. 1042 ¶¶ 30, 31. In the DxH system, use of an electrical detector in both the blood measuring mode and body fluid measuring mode allows identification of total number of cells in measured body fluid.” slip op. at 29
Patent outcomesUS 10,401,351 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Phillips · KSRPatents in suitUS 10,401,351 - Satco Products, Inc. v. The Regents Of The University Of CaliforniaInstitution deniedPTAB · Nov 8, 2021 · IPR2021-00661 · APJ Steven M Amundson · IPR · Institution
The Board denied institution of review for claims 1 and 2 under § 314(a), finding the Fintiv factors weighed against review because of the advanced, overlapping ITC investigation.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied
“The Fintiv factors “relate to whether efficiency, fairness, and the merits support the exercise of authority to deny institution in view of an earlier trial date in the parallel proceeding.” Fintiv, IPR2020-00019, Paper 11 at 6. A stay of parallel litigation pending resolution of a Board proceeding “allays concerns about inefficiency and duplication of efforts.” Id. That the E.D.N.Y. case was stayed “at its earliest stage,” however, does not “allay[] concerns about inefficiency and duplication of efforts” in view of the 1220 investigation. Additionally, the E.D.N.Y. case was stayed “pending completion” of the 1220 investigation, not because of any Board proceeding. Ex. 3002, 1. With dates set in the 1220 investigation for the ALJ’s initial determination and the ITC’s final determination, a stay seems highly unlikely, especially with the initial determination date about a week away. Hence, factor (1) weighs against institution. See Fitbit, Inc. v. Koninklijke Philips N.V., IPR2020-00771, Paper 14 at 16–17 (PTAB Oct. 19, 2020).” slip op. at 18
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“to institute an inter partes review. We may institute an inter partes review only if “the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). But we have discretion to deny a petition even when a petitioner satisfies the “reasonable likelihood” threshold standard for instituting trial. See, e.g., Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2140 (2016) (“[T]he agency’s decision to deny a petition is a matter committed to the Patent Office’s discretion.”). Based on the current record and for the reasons explained below, we exercise our discretion under 35 U.S.C. § 314(a) to deny institution of an inter partes review.” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Not reached
“essentially the same argument about the ’557 patent’s effective filing date for its challenge based on Nakamura-959 and Nakamura-949 as for its invalidity defense based on insufficient written-description support for claim 1. See Pet. 7, 12–21, 37; Ex. 2004, 29–33; Ex. 2005, 245–48; Ex. 2014, 64–65, 70. As we understand the arguments, resolving the ’557 patent’s effective filing date does not require interpreting any part of § 1.57. See Pet. 12–21; Prelim. Resp. 29–31. Instead, the issue turns on whether the ’154 application supports claim 1 according to § 112’s first paragraph. See Pet. 12–21; Prelim. Resp. 29–31. Also, the challenges based on Tanda present a similar issue whether the ’447 provisional supports claim 1 according to § 112’s first paragraph. See Pet. 12–21, 61; Prelim. Resp. 29–31, 36–37. “[T]he test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). Under the circumstances here, the ITC can apply the test for sufficiency of disclosure to the ’154 application and the ’447 provisional just as well as the Board.” slip op. at 27
§ 112 disclosureDiscretionary denialPatents in suitUS 10,658,557 - BASF Corporation v. Ingevity South Carolina, LLCNo claims unpatentablePTAB · Sep 9, 2021 · PGR2020-00037 · APJ Julia Heaney · PGR · Final written decision
Claims 1–10, 14–28, 32–38, 51, 52, 55–57, 59, 64–72, and 76–82 were not shown unpatentable for indefiniteness or obviousness over Hiltzik, Clontz WIPO, and Clontz SAE.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedOther
“art include “(1) educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of workers active in the field.” Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696–697 (Fed. Cir. 1983) (citing Orthopedic Equip. Co. v. All Orthopedic Appliances, Inc., 707 F.2d 1376, 1381–82 (Fed. Cir. 1983)). Not all such factors may be present in every case, and one or more of these or other factors may predominate in a particular case. Id. Petitioner argues a person of ordinary skill in the art at the time of the invention “would possess at least a B.S. in chemistry or chemical or mechanical engineering and would have at least one year of experience working on control of automotive evaporative emissions,” and “would also understand the chemistry and physics associated with the phenomena of fuel vapor adsorption, desorption, and diffusion.” Pet. 28 (citing Ex. 1003 ¶ 17). Patent Owner does not dispute the level of ordinary skill in the art. We adopt Petitioner’s definition of the level of ordinary skill in the art because it is consistent with the ’553 patent and the asserted prior art.” slip op. at 11
- Expert testimonyPatent owner expert creditedDecided for patent owner
“Patent Owner and Dr. Rockstraw present peer-reviewed scientific literature demonstrating that gravimetric and volumetric measurement techniques were known to measure equivalent adsorption capacities and were viewed as compatible with each other. See Ex. 2022 ¶¶ 95–107 (addressing Anson7 (Ex. 2007), Belmabkhout8 (Ex. 1021), Zielinski9 (Ex. 2069)). For example, Belmabkhout reported similar results between measurements by gravimetric and volumetric instruments, except at very high pressures. Ex. 1021, 856–57. Zielinski reported “excellent agreement” between volumetric and gravimetric adsorption capacity measurements (Ex. 2069, 5–6); Dr. Zielinski (who oversaw the testing reported by Intertek 7 Anson, A., et al., “Hydrogen adsorption on a single-walled carbon nanotube material: a comparative study of three different adsorption techniques,” Nanotechnology 15 (2004), 1503. 8 Belmabkhout, Y., et al., “High-pressure adsorption measurements. A comparative study of the volumetric and gravimetric methods,” Measurement Science and Technology 15 (2004) 848. 9 Zielinski, J. et al., “High pressure sorption isotherms via differential pressure measurements,” Adsorption 13 (2007), 1–7. in Ex. 1020) also testified that he would expect capacity measurements for either a gravimetric or volumetric technique to yield the same results, or be “superimposable” under ideal conditions, because they represent “the same experimental measured quantities.” Ex. 2026, 52:11–53:7, 54:13–22, 69:12– 70:3, 139:8–19. Petitioner’s argument that these papers are not relevant because they do not address measurements on the adsorption capacity of n-butane (see Pet. Reply 26) is not persuasive, because Petitioner does not direct us to sufficient evidence showing a reason why measurements of n-butane’s adsorption capacity would have been subject to different measurement inconsistencies. Further, Petitioner’s argument about a 3% deviation in results between the measurement techniques reported in Anson and Belmabkhout is not persuasive because the papers’ conclusions suggest a person of ordinary skill in the art would not have seen such a deviation as significant (e.g., Ex. 1021, 849: “we have not observed important discrepancies” between gravimetric and volumetric measurements). Dr. Rockstraw also testifies as to numerous additional texts and standards that confirm persons of ordinary skill in the art understood that gravimetric and volumetric measurement techniques would provide consistent results when proper experimental protocols are followed and the instruments’ accuracy and precision are taken into consideration. See Ex. 2022 ¶¶ 88–91, 119–127. This evidence is essentially unrebutted by Petitioner. We find that the evidence submitted by Patent Owner as to the gravimetric and volumetric measurement techniques demonstrates that they were well established in the art as comparable methods of measuring adsorption capacity, and accordingly, not a basis for determining claim” slip op. at 16
- ExcludeMotion to exclude, grantedGranted in part
“Exhibit 2027. Paper 57 (“Pet. Mot.”). We do not discuss or cite Exhibit 2080 or paragraph 39 of Exhibit 2027 in this Decision, and consideration of them played no part in our determinations set forth herein. Because their presence in the record would not affect our analysis in this Decision, we dismiss as moot Petitioner’s motion with respect to these exhibits. B. Patent Owner’s Motion to Exclude Patent Owner filed a motion to exclude Exhibits 1015–1016, 1023– 1025, 1032, 1038–1039, 1042 (certain paragraphs), 1044, 1046–1049, and 1052–1054. Paper 56 (“PO Mot.”). Patent Owner groups these exhibits into four categories, which we apply in discussing the motion below. 1. Patent Owner moves to exclude Exhibits 1015 and 1046 as “irrelevant determinations from other adjudicative bodies regarding different patents.” PO Mot. 1. We do not discuss or cite these exhibits in this Decision, and have not considered them in reaching our decision herein. Because the presence of these exhibits in the record would not affect our analysis in this Decision, we dismiss as moot Patent Owner’s motion with respect to these exhibits. 2. Patent Owner moves to exclude Exhibits 1023, 1024, 1025,” slip op. at 46
- Disclosure Requirements (§112) › Definiteness (Nautilus)Written description adequateNot shown unpatentable
“Petitioner has not shown by a preponderance of the evidence that the gravimetric and volumetric methods provide fundamentally different measurements of adsorption capacity. Patent Owner and Dr. Rockstraw present peer-reviewed scientific literature demonstrating that gravimetric and volumetric measurement techniques were known to measure equivalent adsorption capacities and were viewed as compatible with each other. See Ex. 2022 ¶¶ 95–107 (addressing Anson7 (Ex. 2007), Belmabkhout8 (Ex. 1021), Zielinski9 (Ex. 2069)). For example, Belmabkhout reported similar results between measurements by gravimetric and volumetric instruments, except at very high pressures. Ex. 1021, 856–57. Zielinski reported “excellent agreement” between volumetric and gravimetric adsorption capacity measurements (Ex. 2069, 5–6); Dr. Zielinski (who oversaw the testing reported by Intertek 7 Anson, A., et al., “Hydrogen adsorption on a single-walled carbon nanotube material: a comparative study of three different adsorption techniques,” Nanotechnology 15 (2004), 1503. 8 Belmabkhout, Y., et al., “High-pressure adsorption measurements. A comparative study of the volumetric and gravimetric methods,” Measurement Science and Technology 15 (2004) 848. 9 Zielinski, J. et al., “High pressure sorption isotherms via differential pressure measurements,” Adsorption 13 (2007), 1–7. in Ex. 1020) also testified that he would expect capacity measurements for either a gravimetric or volumetric technique to yield the same results, or be “superimposable” under ideal conditions, because they represent “the same experimental measured quantities.” Ex. 2026, 52:11–53:7, 54:13–22, 69:12– 70:3, 139:8–19. Petitioner’s argument that these papers are not relevant because they do not address measurements on the adsorption capacity of n-butane (see Pet. Reply 26) is not persuasive, because Petitioner does not direct us to sufficient evidence showing a reason why measurements of n-butane’s adsorption capacity would have been subject to different measurement inconsistencies. Further, Petitioner’s argument about a 3% deviation in results between the measurement techniques reported in Anson and Belmabkhout is not persuasive because the papers’ conclusions suggest a person of ordinary skill in the art would not have seen such a deviation as significant (e.g., Ex. 1021, 849: “we have not observed important discrepancies” between gravimetric and volumetric measurements). Dr. Rockstraw also testifies as to numerous additional texts and” slip op. at 16
Patent outcomesUS 10,323,553 not shown unpatentable§ 103 obviousness§ 112 disclosurecites KSR · Graham · NautilusPatents in suitUS 10,323,553 - PTAB · Mar 31, 2021 · IPR2020-00001 · APJ Jeffrey W Abraham · IPR · Final written decision
The Board canceled claims 1, 5, 8, and 10–12, but denied entry of substitute claims 20–25 because claims 20 and 24 were indefinite and claims 21–23 and 25 were obvious.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“LEVEL OF ORDINARY SKILL IN THE ART In the Institution Decision, we determined that “a person of ordinary skill in the art would have had sufficient experience and/or education in the food industry to possess an understanding of (1) sugar particle size as it pertains to brewed beverages and (2) sugar particle size screening.” Inst. Dec. 7. We observed that this level of ordinary skill is consistent with the level of ordinary skill that we adopted in a related case that involves similar subject matter. See Red Diamond, Inc. v. Southern Visions, LLP, PGR2019- 00045, Paper 9 at 6–8 (PTAB Oct. 15, 2019). We also asked the parties to expressly discuss the level of ordinary skill in the art in the remaining briefing if either party disagreed with our determination. Inst. Dec. 7–8. For purposes of this Final Written Decision, we maintain our determination from the Institution Decision because neither party disputes the level of ordinary skill identified in the Institution Decision (see Revised MTA 7–8), and because we continue to find that the stated level of ordinary skill is consistent with the record.” slip op. at 5
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“consider” the Revised Motion to Amend and cancel original claims 1, 5, 8, and 10–12. Revised MTA 1. Because Patent Owner has not indicated that our consideration of the Revised Motion to Amend is contingent on a determination that original challenged claims 1, 5, 8, and 10–12 are unpatentable, we grant Patent Owner’s request to cancel original challenged claims 1, 5, 8, and 10–12. See Lectrosonics, Inc. v. Zaxcom, Inc., IPR2018- 01129, Paper 15 at 3 (PTAB Feb. 25, 2019) (precedential) (“Lectrosonics”) (“A request to cancel claims will not be regarded as contingent.”). The remaining issue before us is whether to grant the Revised Motion to Amend as to proposed substitute claims 20–25.” slip op. at 6
- Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteUnpatentable
“sugar, which indicates that between 2–25% of the particles in EFG sugar can have a size in the range of U.S mesh sieve nos. 20–30. Ex. 2003, 42 (showing the “Typical Analysis” for “X-fine” granulated sugar). Even if we were to agree with Patent Owner that this shows a typical analysis for EFG sugar, it still presents a variance of up to 20% for particles having a size in the range of U.S. mesh sieve nos. 20 and 30. Ex. 2003, 42. Thus, the evidence of record suggests that the particle size distribution for EFG sugar, including the number of particles falling in the range of U.S. mesh sieve nos. 3–35, can vary among different EFG sugars. Thus, the term “typical grocery store sugar,” “might mean several different things” in terms of the number of its particles having a size in the range of U.S. mesh sieve nos. 3–35, and “no informed and confident choice is available among the contending definitions.” HZNP Meds. LLC v. Actavis Labs UT, 940 F.3d 680, 698 (Fed. Cir. 2019) (quoting Media Rights Techs., Inc. v. Capital One Fin. Corp., 800 F.3d 1366, 1371 (Fed. Cir. 2015)); Opp. 9; Reply 4.” slip op. at 15
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“sugar in its products (Ex. 1008, 11:2–5), and Mr. Ebersole’s testimony demonstrates that a person of ordinary skill in the art would have known that Standard Grade and Medium Grade sugars are commercial grade granulated sugars and that the particles in Standard Granulated and Medium Granulated sugars “are almost entirely within the range of U.S. mesh nos. 3–35” (Ex. 2076 ¶ 51). The evidence of record thus supports Petitioner’s assertion that following the typical industry practice of using 1 ounce of tea particles and 1 pound of sugar per gallon of tea, and using a commercial grade granulated sugar (as taught by Cooper) such as Standard Granulated or Medium Granulated sugar (which are known to be “almost entirely within the range of U.S. mesh nos. 3–35”), would yield a product having a blend ratio of tea particles to sugar granules having a size in the range of U.S. mesh sieve nos. 3–35 in the range of 1:16–1:25, as recited in proposed substitute claims 21 and 23. Opp. 20–21; Ex. 1008, 11:2–5; Ex. 1001, 17–20, 57–65. In view of the foregoing, we find Petitioner has established sufficiently that the teachings of Cooper, considered in view of admitted prior art sweetening practices, teaches or suggests all of the limitations of proposed substitute claims 21 and 23. Petitioner has presented evidence demonstrating sufficiently that Cooper teaches the use of sugar having particle sizes falling “almost entirely” within the range of mesh 3–35, that following typical industry practices using such sugar would result in the claimed blend ratio of tea to sugar having a size in the range of mesh 3–35, and that a person of ordinary skill in the art would have had reason to brew commercial-sized batches of tea, with a reasonable expectation of success in doing so, as Cooper allows.” slip op. at 26
§ 103 obviousness§ 112 disclosurecites KSR · NautilusPatents in suitUS 9,549,634 - Red Diamond, Inc. v. Southern Visions, LLPAll claims unpatentablePTAB · Mar 31, 2021 · IPR2019-01671 · APJ Jeffrey W Abraham · IPR · Final written decision
The Board canceled claims 1, 6, and 10–12 and denied entry of substitute claims 18–22, finding claims 18–21 indefinite and claim 22 obvious.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“C. LEVEL OF ORDINARY SKILL IN THE ART In the Institution Decision, we determined that “a person of ordinary skill in the art would have had sufficient experience and/or education in the food industry to possess an understanding of (1) sugar particle size as it pertains to brewed beverages, (2) sugar particle size screening, and (3) the storage and use of sugar in commercial settings.” Inst. Dec. 6–7. We observed that this level of ordinary skill is consistent with the level of ordinary skill that we adopted in a related case that involves similar subject matter. See Red Diamond, Inc. v. Southern Visions, LLP, PGR2019-00045, Paper 9 at 6–8 (PTAB Oct. 15, 2019). We also asked the parties to expressly discuss the level of ordinary skill in the art in the remaining briefing if either party disagreed with our determination. For purposes of this Final Written Decision, we maintain our determination from the Institution Decision because neither party disputes the level of ordinary skill identified in the Institution Decision (see Revised MTA 11–12), and because we continue to find that the stated level of ordinary skill is consistent with the record.” slip op. at 5
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“II. MOTION TO AMEND A. ORIGINAL CHALLENGED CLAIMS As noted above, Patent Owner requests that we “unconditionally consider” the Revised Motion to Amend and cancel original claims 1, 6, and 10–12. Revised MTA 1. Because Patent Owner has not indicated that our consideration of the Revised Motion to Amend is contingent on a determination that original challenged claims 1, 6, and 10–12 are unpatentable, we grant Patent Owner’s request to cancel original challenged claims 1, 6, and 10–12. See Lectrosonics, Inc. v. Zaxcom, Inc., IPR2018- 01129, Paper 15 at 3 (PTAB Feb. 25, 2019) (precedential) (“Lectrosonics”) (“A request to cancel claims will not be regarded as contingent.”). The remaining issue before us is whether to grant the Revised Motion to Amend as to proposed substitute claims 18–22.” slip op. at 6
- Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteUnpatentable
“Particle size is a critical factor for proposed substitute claims 18 and 20, which require a comparison of the particle size of the sugar used in the recited mesh pouch against the particle size of Sugar in the Raw. For all of the reasons discussed above, we find a person of ordinary skill in the art would not have understood that the trademark Sugar in the Raw identifies sugar having particles of a particular size with sufficient specificity to allow the comparison of particle sizes that proposed substitute claims 18 and 20 require. Accordingly, proposed substitute claims 18 and 20 are indefinite because they “fail[ ] to inform, with reasonable certainty, those skilled in the art about the scope of the invention.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014); see USPTO Memorandum on the Approach to Indefiniteness Under 35 U.S.C. § 112 in AIA Post-Grant Proceedings (Jan. 6, 2021)6; MPEP 2173.05(e) (9th ed., Rev. 08.2017, June 2020).” slip op. at 18
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“analogous art. Reply 7. “A reference qualifies as prior art for an obviousness determination under § 103 only when it is analogous to the claimed invention.” In re Klein, 647 F.3d 1343, 1348 (Fed. Cir. 2011). “Two separate tests define the scope of analogous prior art: (1) whether the art is from the same field of endeavor, regardless of the problem addressed and, (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). Even if we were to agree with Patent Owner that Thijssen is not from the same field of endeavor because, inter alia, it involves the use of a packed bed, we still find Thijssen to be analogous art because it is reasonably pertinent to the problem with which the inventors were involved. The ’330 patent teaches that “[t]he larger sugar granules allow the water to flow around it at the same time you are extracting tea from the tea blend.” Ex. 1001, 7:15–17. This indicates that among the problems “with which the inventor[s were] involved” were extraction of flavor from tea and the flow of water around the particles involved in the tea brewing process. Thijssen likewise addresses the flow of solvent through solid particles during extraction of a beverage product. See, e.g., Ex. 1022, 2:46–48. In view of this, we find Thijssen is “reasonably pertinent to the particular problem with which the inventor[s were] involved.” Bigio, 381 F. 3d at 1325.” slip op. at 33
Patent outcomesUS 9,468,330 unpatentable§ 103 obviousness§ 112 disclosurecites NautilusPatents in suitUS 9,468,330 - PTAB · Mar 31, 2021 · IPR2019-01662 · APJ Jeffrey W Abraham · IPR · Final written decision
The Board canceled claims 1, 8, 13, and 17; it denied entry of substitute claims 23–26 because claims 23 and 25 lacked written-description support and claims 24 and 26 were indefinite.
RulingsFinal written decision- Skill levelSkill level board ownOther
“C. LEVEL OF ORDINARY SKILL IN THE ART In the Institution Decision, we determined that “a person of ordinary skill in the art would have had sufficient experience and/or education in the food industry to possess an understanding of (1) sugar particle size as it 1 “One degree Brix is one gram of sucrose in 100 grams of solution . . . . Brewed sweetened tea has a typical Brix level of 10½ to 11.” Ex. 1001, 1:35–43. pertains to brewed beverages, (2) sugar particle size screening, and (3) the storage and use of sugar in commercial settings.” Inst. Dec. 7. We observed that this level of ordinary skill is consistent with the level of ordinary skill that we adopted in a related case that involves similar subject matter. See Red Diamond, Inc. v. Southern Visions, LLP, PGR2019-00045, Paper 9 at 6– 8 (PTAB Oct. 15, 2019). We also asked the parties to expressly discuss the level of ordinary skill in the art in the remaining briefing if either party disagreed with our determination. Inst. Dec. 8. For purposes of this Final Written Decision, we maintain our determination from the Institution Decision because neither party disputes the level of ordinary skill identified in the Institution Decision (see Revised MTA 12–13), and because we continue to find that the stated level of ordinary skill is consistent with the record.” slip op. at 4
- 112 supportMotion to amend, deniedDenied
“Structurally, Patent Owner has claimed a broad genus of brewing products – any product that includes sugar having particles in the range of U.S. mesh size nos. 3–35. Patent Owner attempts to further distinguish the genus by including the functional limitation of requiring the product to be capable of producing a tea with a Brix level of at least 10.5 degrees. Patent Owner does not dispute that there are products falling within the structural limitations that do not satisfy the functional limitations. Indeed, there is undisputed testing evidence on the record demonstrating that the entire range of recited structures does not perform the recited function. See Ex. 2076 at Exhibit C, 20–29 (Table 3); Revised MTA 8 (Patent Owner arguing the claims only cover products that include particles within the claimed range that perform the recited function). Here, we discern no evidence on this record of “a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350. Nor do we discern “a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials” in the disclosures, or evidence that “the art has established a correlation between structure and function.” Id. Instead, we view Patent Owner’s proposed substitute claims to involve “merely drawing a fence around the outer limits of a purported genus,” which “is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” Id. We recognize that the subject matter here is different from, and less complex than, the chemical and biochemical subject matter in Ariad. Nevertheless, the written description requirement still requires sufficient description to convey to one of skill in the relevant art that the inventors “had possession of the claimed invention” and “showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” Id. at 1351, 1356. Thus we consider the difference in technology in determining “the level of detail required to satisfy the written description requirement,” but do not consider the difference in technology to eliminate entirely the need for some disclosure in the specification indicating possession of the claimed invention. Id. at 1351. Patent Owner has not directed us to any portion of the ’526 or ’881” slip op. at 20
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot shown unpatentable
“Structurally, Patent Owner has claimed a broad genus of brewing products – any product that includes sugar having particles in the range of U.S. mesh size nos. 3–35. Patent Owner attempts to further distinguish the genus by including the functional limitation of requiring the product to be capable of producing a tea with a Brix level of at least 10.5 degrees. Patent Owner does not dispute that there are products falling within the structural limitations that do not satisfy the functional limitations. Indeed, there is undisputed testing evidence on the record demonstrating that the entire range of recited structures does not perform the recited function. See Ex. 2076 at Exhibit C, 20–29 (Table 3); Revised MTA 8 (Patent Owner arguing the claims only cover products that include particles within the claimed range that perform the recited function). Here, we discern no evidence on this record of “a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350. Nor do we discern “a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials” in the disclosures, or evidence that “the art has established a correlation between structure and function.” Id. Instead, we view Patent Owner’s proposed substitute claims to involve “merely drawing a fence around the outer limits of a purported genus,” which “is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.” Id. We recognize that the subject matter here is different from, and less complex than, the chemical and biochemical subject matter in Ariad. Nevertheless, the written description requirement still requires sufficient description to convey to one of skill in the relevant art that the inventors “had possession of the claimed invention” and “showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.” Id. at 1351, 1356. Thus we consider the difference in technology in determining “the level of detail required to satisfy the written description requirement,” but do not consider the difference in technology to eliminate entirely the need for some disclosure in the specification indicating possession of the claimed invention. Id. at 1351. Patent Owner has not directed us to any portion of the ’526 or ’881” slip op. at 20
- Disclosure Requirements (§112) › Definiteness (Nautilus)IndefiniteUnpatentable
“which indicates that between 2–25% of the particles in EFG sugar can have a size in the range of U.S mesh sieve nos. 20–30. Ex. 2003, 42 (showing the “Typical Analysis” for “X-fine” granulated sugar). Even if we were to agree with Patent Owner that this shows a typical analysis for EFG sugar, it still presents a variance of up to 20% for particles having a size in the range of U.S. mesh sieve nos. 20 and 30. Ex. 2003, 42. Thus, the evidence of record suggests that the particle size distribution for EFG sugar, including the number of particles falling in the range of U.S. mesh sieve nos. 3–35, can vary among different EFG sugars. Thus, the term “typical grocery store sugar,” “might mean several different things” in terms of the number of its particles having a size in the range of U.S. mesh sieve nos. 3–35, and “no informed and confident choice is available among the contending definitions.” HZNP Meds. LLC v. Actavis Labs UT, 940 F.3d 680, 698 (Fed. Cir. 2019) (quoting Media Rights Techs., Inc. v. Capital One Fin. Corp., 800 F.3d 1366, 1371 (Fed. Cir. 2015)); Opp. 7–10; Reply 4. Proposed substitute claims 24 and 26 compare the dissolution of the claimed beverage brewing product against the dissolution of a product using typical grocery store sugar (i.e., EFG). Patent Owner explains that the size of the particles affects dissolution – namely that larger sugar is more advantageous – in the claimed invention. See, e.g., Revised MTA 5; Ex. 1001, 9:23–27, 10:19–22. This suggests that an EFG sugar product having a greater percentage of large particles will be capable of dissolving “more of granulated sugar” as compared to an EFG sugar product having a lower percentage of large particles. As a result, using the dissolution properties of “typical grocery store sugar” as a comparator in the claims is problematic as there is a potential for inconsistent results based on which particular EFG sugar product is used. The potential for inconsistent results undermines Patent Owner’s argument that these claims satisfy the definiteness requirement because a person of ordinary skill in the art “can buy EFG . . . and perform brew tests with it in order to determine the scope of the claims.” Reply 4. Particle size is a critical factor for proposed substitute claims 24 and 26, which require a comparison of dissolution properties of the sugar used in the recited brewing product and typical grocery store sugar. Patent Owner contends “[t]here is an ‘informed and confident’ choice for ‘typical grocery store sugar’ - EFG sugar.” Reply 4. The evidence of record, however, shows the number of large particles (3–35 mesh) varies among EFG sugars. Ex. 2003, 42; Ex. 1004, at pages 51–53. In view of this, we find a person of ordinary skill in the art would not have understood “typical grocery store sugar” identifies sugar having particles of a particular size with sufficient specificity to allow the comparisons that proposed substitute claims 24 and 26 require. Accordingly, proposed substitute claims 24 and 26 are indefinite because they “fail[ ] to inform, with reasonable certainty, those skilled in the art about the scope of the invention.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901 (2014); see USPTO Memorandum on the Approach to Indefiniteness Under 35 U.S.C. § 112 in AIA Post-Grant Proceedings (Jan. 6, 2021); MPEP 2173.05(e) (9th ed., Rev. 08.2017, June 2020).” slip op. at 25
§ 112 disclosurecites NautilusPatents in suitUS 9,725,232
Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.