- Synaffix B.V. v. Hangzhou Dac Biotech Co., Ltd.Institution deniedPTAB · Aug 22, 2023 · IPR2022-01531 · APJ Devon Zastrow Newman · IPR · Institution
Institution was denied for claims 1–17, 20–21, 24–26, and 29–34 because petitioner did not show a reasonable likelihood of prevailing on any asserted ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“An inter partes review may be instituted only if “the information presented in the petition . . . and any [preliminary] response . . . 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). Upon consideration of the briefing and the evidence of record, we conclude that Petitioner has not established a reasonable likelihood of prevailing on its assertion that the challenged claims are unpatentable based on the grounds advanced here. Accordingly, we deny institution of inter partes review of claims 1–17, 20–21, 24–26, and 29–34 of the ’682 patent.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer foundDecided for patent owner
“Ex. 1018, 42–43. The Examiner found that Lees discloses NHS vinyl sulfone as a heterobifunctional linker used to attach a derivatized polysaccharide to one end and a protein to the other and found that this compound anticipated formula 55 of the Specification, which was encompassed by claim 1. Id. at 42–43.” slip op. at 22
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentable
“For the reasons discussed above regarding claim interpretation of Y, Z, Q and T, Patent Owner has the better argument for claims 1 and 2. Specifically, Y and Z are independent groups that function without reliance this ground for claims 1 and 2 rely on sulfone to assist vinyl to enable the reaction above, Petitioner is unlikely to prevail in establishing that Morales- Sanfrutos discloses the Y or Z limitations and has therefore not established a reasonable likelihood of prevailing in showing that the disclosures of Morales-Sanfrutos in light of Straus anticipate claims 1 and 2. With regard to claims 3, 6, 24, 25, and 33 we are persuaded by Patent Owner’s argument that Petitioner’s assignment of sulfone for the Q moiety is incorrect because that group becomes complexed to HRP through a vinylsulfone mediated reaction, making a derivatized protein, e.g., HRP-11. Prelim. Resp. 48 (citing Ex. 1005, 4046). In this structure, sulfone is no longer an independent group available to be identified as Q because it has been complexed to the Cb moiety, making the Q moiety limitation not shown in the HRP-11 conjugate. Thus, Petitioner has not established a reasonable likelihood of prevailing in showing that Morales-Sanfrutos discloses the Q limitation and has therefore not established a reasonable likelihood of prevailing in showing that the disclosures of Morales-Sanfrutos in light of Straus anticipate claims 3, 6, 24, 25, and 33.17” slip op. at 28
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentable
“d) Petitioner’s allegations of obviousness A patent claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the claimed subject matter and the prior art are such that the subject matter, as a whole, would have been obvious at the time the invention was made to a person having ordinary skill in the art to which the subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). In this section, we determine whether Petitioner shows sufficiently, for purposes of institution, that claims 1, 20, 21, and 29–31 would have been rendered obvious by Harris.” slip op. at 32
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,131,682 - Nextremity Solutions, Inc. / Zimmer Biomet Holdings, Inc. et al. v. Extremity Medical, LLCAll claims unpatentablePTAB · Jul 26, 2023 · IPR2022-00802 · APJ Jeffrey N Fredman · IPR · Final written decision
Claim 59 is unpatentable as anticipated by Brumfield, Marcus, and Chandran; the motion to amend proposing substitute claim 62 is denied because claim 62 is unpatentable.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“We find this argument unpersuasive. As Patent Owner notes, Petitioner’s expert provides a definition of POSITA that is very similar to that recited by Patent Owner in its Motion to Amend, substantively differing only in the number of years of experience of the engineer at issue. This congruity supports the conclusion that the level of ordinary skill in the art may be recognized in the prior art itself. Okajima, 261 F.3d at 1355 (“the absence of specific findings on the level of skill in the art does not give rise to reversible error ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown’”).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“In our Institution Decision, we agreed with Petitioner that the “portion of the preamble reciting ‘for compressing bone’ is not limiting to the claim” and found that other terms did not require construction. Dec. 8–9. We agreed with Petitioner that “[t]he phrase ‘for compressing bone’ merely identifies an intended use.” Pet. 20; Dec. 9. Patent Owner does not dispute this interpretation. See generally PO Resp. We agree with Petitioner that “the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). Therefore, having considered the entire record developed during trial, we adhere to the preliminary construction that the limitation “for compressing bone” does not impose a structural limitation on claim 59 and that the other terms do not require construction.” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Patent Owner disputes the Petition generally but Patent Owner does not identify any error in Petitioner’s foregoing arguments. Accordingly, we adopt the factual statements regarding the specific teachings of the references as findings of fact. See generally In re NuVasive, 841 F.3d 966, 974 (Fed. Cir. 2016) (explaining that the Board need not make specific findings as to claim limitations that Patent Owner does not dispute are disclosed in the prior art). We have reviewed Petitioner’s analysis and the underlying evidence cited in support and conclude that Petitioner has shown, by a preponderance of the evidence, that the limitations of claim 59 are disclosed by Brumfield.” slip op. at 26
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied
“For the reasons discussed below, Patent Owner has shown that proposed substitute claim 62 meets the statutory and regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121. For the reasons discussed below, however, Petitioner has proven by a preponderance of the evidence that proposed substitute claim 62 is unpatentable over prior art. Therefore, we deny Patent Owner’s Revised Motion to Amend.” slip op. at 38
Patent outcomesUS 8,303,589 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · NautilusPatents in suitUS 8,303,589 - Apotex Inc. v. Cellgene CorporationInstitutedPTAB · Jul 20, 2023 · IPR2023-00512 · APJ Ryan H Flax · IPR · Institution
The Board instituted IPR on claims 1, 2, 6–9, 11–28, 32–36, and 38–43 on all asserted grounds, finding a reasonable likelihood of success on obviousness.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“IV. CONCLUSION Petitioner demonstrates a reasonable likelihood of prevailing at trial in showing that at least one of claims 1, 2, 6–9, 11–28, 32–36, and 38–43 of the ’628 patent is unpatentable over the cited prior art. Our decision derives from our review of the preliminary record before us. Accordingly, we institute inter partes review of each challenged claim the ’628 patent on each of the grounds asserted by Petitioner. This decision does not reflect a final determination on the patentability of the claims. ORDER Accordingly, it is hereby: ORDERED that the Petition is granted and we institute inter partes review of claims 1, 2, 6–9, 11–28, 32–36, and 38–43 of the ’628 patent based on the grounds asserted in the Petition.” slip op. at 53
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for petitioner
“patentee that differs from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.” Phillips, 415 F.3d at 1316 (citing CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002)). Moreover, “[w]hen the specification explains and defines a term used in the claims, without ambiguity or incompleteness, there is no need to search further for the meaning of the term.” Multiform Dessicants, Inc. v. Medzam Ltd., 133 F.3d 1473, 1478 (Fed. Cir. 1998). We agree with the parties that the ’628 patent expressly defines this term in stating “[t]he term ‘non-enteric-coated,’ when used herein, refers to a pharmaceutical composition, formulation, or dosage form that does not comprise a coating intended to release the active ingredient(s) beyond the stomach (e.g., in the intestine),” and we adopt this express definition herein with regard to “nonenteric coated tablet.”9 Ex. 1001, 11:42–48 (emphasis added).” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“to, and sometimes associated with, but not identical to the claim term “subject”), which appears in claims 11, 12, 18–22, and 38–43, means “a human or other animal who received the recited pharmaceutical composition in connection with a test of the recited parameter.” Prelim. Resp. 18–19 (also asserting Petitioner does not appear to dispute this construction). We first note that the term “test subject” appears in the ’628 patent only in the claims. See generally Ex. 1001. However, we find Patent Owner’s definition comports with the Specification’s express definition of “subject,” a term the Specification appears to use synonymously with the claim term “test subject” and the word patient, and that Patent Owner’s definition adds that the subject received the pharmaceutical composition in connection with a test of the recited parameter, which we find to be a reasonable interpretation of the claim term “test subject,” in accordance with the plain language of the claims on their face, and as supported by the relevant portions of the Written Description that describe testing parameters relating to drug administration. Ex. 1001, 35:45–36:62, 67:61–81:48. We adopt Patent Owner’s definition herein.” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable
“A single prior art reference may anticipate without disclosing a feature of the claimed invention if such feature is necessarily present, or inherent, in that reference.” Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 958 (Fed. Cir. 2014). However, “‘[i]nherency . . . may not be established by probabilities or possibilities.’” In re Montgomery, 677 F.3d 1375, 1379–80 (Fed. Cir. 2012) (citations omitted, alterations in original). “The mere fact that a certain thing may result from a given set of circumstances is not sufficient to establish inherency.” Scaltech Inc. v. Retec/Tetra L.L.C., 178 F.3d 1378, 1384 (Fed. Cir. 1999). slip op. at 38
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,846,628 - Painteq, LLC v. Orthocision, Inc.InstitutedPTAB · Jul 12, 2023 · IPR2023-00451 · APJ Michael A Valek · IPR · Institution
The Board instituted IPR on claims 1–23 based on all petition grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“On the current record, we determine that the Petition demonstrates “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). Accordingly, we institute an inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have had a medical or an engineering degree and would have had experience with surgical instruments and implants used for spinal joint fusion, including [sacroiliac (“SI”)] joint fusion.” Pet. 7 (citing Ex. 1002 ¶ 15). At this stage, we find Petitioner’s description of the level of ordinary skill in the art to be sufficiently supported by the record and apply it for purposes of this Decision. slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner submits that the parties have submitted joint claim construction in the Florida litigation, and asserts that “[t]he grounds set forth in this [P]etition render the challenged claims obvious under either party’s construction.” Pet. 8 (citing Ex. 1002 ¶ 34; Ex. 1017). Nevertheless, Petitioner urges that “express construction is not necessary.” Id. at 7. At this stage of the proceeding and for purposes of instituting trial, we determine that there are no terms that require express construction. See” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“We agree with Petitioner. Figures 30, 32A and 32B in the Specification depict a working channel with tangs 180a and 180b. See Ex. 1001, Figs. 30, 32A–B. These figures and all of the related description in the Specification describing a working channel with tangs appear in the Parent (Ex. 1006, Figs. 30, 32A–B, 3:17–21, 6:47–54, 15:25–51), but not in the Grandparent. See also Ex. 1002 ¶¶ 42–43 (explaining the same). Accordingly, based on the current record, we find that the Grandparent application does not provide sufficient written description for the limitations requiring that the working channel have tangs in the independent claims. See Ex. 1001, 42:7 (limitation 1.b.4 “at least one tang on a distal end”), 43:9–11 (limitation 10.b.2 “two bilateral blunt tangs on a distal end”), 44:31–32 the challenged claims are not entitled to the benefit of the Grandparent’s filing date.” slip op. at 9
Claim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,083,511 - Yita LLC / Jinrong (SH) Automotive Accessory Industrial Development Co. Ltd. v. Macneil IP LLCInstitutedPTAB · Jun 13, 2023 · IPR2023-00173 · APJ Arthur M Peslak · IPR · Institution
The Board instituted review of claims 1–6 on the asserted obviousness grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“whether to institute an inter partes review under 35 U.S.C. § 314(a). See also 37 C.F.R § 42.4(a) (2021) (“The Board institutes the trial on behalf of the Director.”). Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the Petition shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.”” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We need not explicitly construe the term “vehicle floor tray” or any other claim term for the purposes of this decision. See Realtime Data, LLC v. Iancu, 912 F.3d 1368 (Fed. Cir. 2019) (“The Board is required to construe ‘only those terms . . . that are in controversy, and only to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). However, we offer the following reasons for not adopting Patent Owner’s proposed construction. Claim 1 recites the term “vehicle floor tray” but does not recite any specific structural details of the tray. Ex. 1001, 19:42–60. Thus, nothing in the claim language suggests the structural aspects of a vehicle floor tray included in Patent Owner’s proposed construction.” slip op. at 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“B. Level of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art “would have had a bachelor’s degree in mechanical engineering, industrial design, or a closely related field, or equivalent formal training, education, or practical experience in a field relating to product design, CAD, or manufacturing.” Pet. 13 (citing Ex. 1003 ¶¶ 27–28). Petitioner further contends that the person of ordinary skill in the art “would also have a minimum of three to five years of experience in plastics engineering, CAD, manufacturing, plastic product design, or a related industry,” but that “a higher level of training or practical experience might make up for less education, and vice-versa.” Id. Patent Owner does not, at this stage of the proceeding, dispute Petitioner’s definition of the person of ordinary skill in the art. Prelim. Resp. 12. For the purposes of this Decision, we apply Petitioner’s proposed level of skill in the art because it appears consistent with the problems addressed in the ’917 patent and the prior art.” slip op. at 12
- Expert testimonyPetitioner expert creditedDecided for petitioner
“In his testimony concerning background prior art, Mr. Perreault relies on two prior art patents that disclose “floor mats” described similarly to Patent Owner’s description of a “vehicle floor tray.” See Ex. 1003 ¶¶ 29–30 (citing Ex. 1013 (“Bailey”); Ex. 1015 (“Tyler”)). Bailey describes a “floor mat” that is “molded or otherwise preformed into a tray-like shape which conforms to the contour of a portion of the carpeted automobile floor. The mat is dimensioned and configured to nest within and abut against the sides of a carpeted floor well of the vehicle.” Ex. 1013, 2:37–42, Fig. 6. Tyler describes “contoured vehicle floor mats” that “mate[] with the vehicle floorboard to hold the mat in place.” Ex. 1013, code (57), 1:52–54. Based on these exhibits, we find that Mr. Perreault’s testimony is not conclusory and not based on an improper definition of floor tray. Based on the present record and after considering Patent Owner’s contentions, Petitioner sufficiently establishes that Stanesic discloses the subject matter of the preamble. In particular, Stanesic discloses “a tray-like central area” and “the raised wall 22 has two walls that rise about one to about two inches from the base 15” (Ex. 1005, 2:61–62), which sufficiently supports Petitioner’s contention that Stanesic discloses, or at least suggests, a vehicle floor tray.” slip op. at 22
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,138,917 - Yita LLC / Jinrong (SH) Automotive Accessory Industrial Development Co. Ltd. v. Macneil IP LLCInstitutedPTAB · Jun 13, 2023 · IPR2023-00172 · APJ Arthur M Peslak · IPR · Institution
The Board instituted inter partes review of claims 1–6 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim would be unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“whether to institute an inter partes review under 35 U.S.C. § 314(a). See also 37 C.F.R § 42.4(a) (2021) (“The Board institutes the trial on behalf of the Director.”). Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the Petition shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.”” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“and Cicotte, the dispute for the first prong of the Advanced Bionics framework revolves around whether Rothkop is cumulative of Exhibits 2001, 2002, 2003, and 2004 cited in an IDS considered by the Examiner. Petitioner does not dispute that Cicotte is cumulative of Exhibit 2005 or 2006. See Prel. Reply. For the purposes of the § 325(d) analysis, we will assume, without deciding, that Rothkop is cumulative of at least one of the references Patent Owner relies on, i.e., Exhibits 2001, 2002, 2003, and 2004. We, thus, assume, without deciding, that the first prong of the Advanced Bionics framework is satisfied and move to the second prong. 4. Advanced Bionics Framework, Prong Two: Has Petitioner Demonstrated that the Office Erred in a Manner Material to the Patentability of the Challenged Claims? The ’655 patent issued from an application filed on August 6, 2014.” slip op. at 45
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“For the following reasons, we do not adopt Patent Owner’s proposed construction. Claim 1 recites a “vehicle floor tray” but does not recite any specific structural details of the tray. Ex. 1001, 19:46–2:2. Thus, nothing in the claim language suggests the aspects of a vehicle floor tray included in Patent Owner’s proposed construction. Patent Owner does not direct us to an explicit lexicographic definition of the term “vehicle floor tray” in the Specification of the ’655 patent. Rather, Patent Owner relies on descriptions of aspects of the embodiment disclosed in Figure 1 of the ’655 patent. For example, the ’655 patent generally describes that “[f]loor trays have sidewalls.” Ex. 1001, 1:58. The ’655 patent states that in an “aspect” of the invention, “a vehicle floor tray has a central panel for the placement on the floor of a vehicle foot well, and at least first and second upstanding panels.” Id. at 5:28–30. In column 7, the ’655 patent describes that “[d]isposed around the central or floor panel 102 are a series of upstanding side panels, which will vary in number and configuration from one vehicle model to the next.” Id. at 7:47–49 (emphasis added). These portions of the Specification suggest that the term “vehicle floor tray” should not be limited to any particular number of side panels or any particular configuration such as the side panels are joined to the floor panel and each other. In the Summary of the Invention, the ’655 patent discloses “a vehicle” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“For the following reasons, Patent Owner’s contentions are unavailing based on the present record. First, as discussed above, Patent Owner’s attempt to draw a distinction between floor trays and floor mats is unavailing based on the present record and undercut by its own exhibits describing Patent Owner’s vehicle floor trays as “mats.” See Ex. 2010; Ex. 2012; Ex. 2013; Ex. 2014. Second, as discussed above, the fact that Petitioner has not shown that someone previously scanned a vehicle footwell is unavailing because this challenge is based on obviousness, not anticipation. Third, the sentence in Rothkop that Patent Owner contends discloses a kind of scanner, not what is to be scanned, is “[t]he data input device may comprise a scanner 12 for scanning a physical part such as an existing seat, frame, or vehicle.” Ex. 1006, 4:61– 63. Based on the present record, we do not agree that this sentence discloses a type of scanner. Fourth, Patent Owner’s arguments concerning the claimed invention creating a new product versus reverse engineering an existing product in Rothkop raises potential fact questions that are best resolved at trial based on a fully developed record. Petitioner provides numerous reasons why a person of ordinary skill in the art would have been motivated to combine Stanesic, Rothkop, and Cicotte in such a manner that teaches or suggests all limitations of claim 1. Pet. 29–34. Petitioner sufficiently supports this reasoning with the testimony of Mr. Perreault that he supports with reference to Stanesic, Rothkop, Cicotte, and other references showing the background art. Ex. 1003 ¶¶ 147–157. Further, Patent Owner does not dispute Petitioner’s conclusion that the combination of Stanesic, Rothkop, and Cicotte “would be nothing more than applying known techniques . . . to a known method of producing a custom-fit vehicle floor tray . . . that is ready for improvement, yielding the predictable result of generating a custom-fit floor tray.” Compare Pet. 33, with Prelim. Resp. Based on the present record and after considering all of Patent” slip op. at 32
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,899,655 - Candela Corporation v. Nikolai TankovichInstitutedPTAB · Jun 8, 2023 · IPR2023-00234 · APJ Devon Zastrow Newman · IPR · Institution
The Board instituted IPR on claims 1–28, finding a reasonable likelihood that the challenged claims would be unpatentable under the five asserted § 103 grounds.
RulingsInstitution decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“when no part of the distribution patterns of the two beams cross each other at the point of reference, identified above in Figure 2D–F as “in a tissue.” Id. As both claim 1 and claim 11 refer to tissue treatment, we interpret the point of reference for determining whether the beams overlap to be the point at which the beams first intersect the tissue being treated. This interpretation is supported by the diagrams in Figure 2 above and in the Specification. See, e.g., Ex. 1001, 1:67–2:4 (“The invention can avoid interference of the wavelengths by delivering the wavelengths simultaneously and in spatially separated and overlapping regions of the tissue being treated.”). In view of the above, we determine that the term “overlapping,” as used in the claims, refers to the crossing of the beam pattern at the point at which the beams intersect the tissue being treated.” slip op. at 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“when no part of the distribution patterns of the two beams cross each other at the point of reference, identified above in Figure 2D–F as “in a tissue.” Id. As both claim 1 and claim 11 refer to tissue treatment, we interpret the point of reference for determining whether the beams overlap to be the point at which the beams first intersect the tissue being treated. This interpretation is supported by the diagrams in Figure 2 above and in the Specification. See, e.g., Ex. 1001, 1:67–2:4 (“The invention can avoid interference of the wavelengths by delivering the wavelengths simultaneously and in spatially separated and overlapping regions of the tissue being treated.”). In view of the above, we determine that the term “overlapping,” as used in the claims, refers to the crossing of the beam pattern at the point at which the beams intersect the tissue being treated.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“Black discloses that its combined beam can be controlled to rotate the mirrors to “generate various different kinds of treatment patterns” and can “create any type of three-dimensional paths and treatment pattern.” See Ex. 1006 ¶¶ 61, 62; Ex. 1002 ¶ 69. On this record and at this stage, the ability to generate treatment patterns meets the limitations of the claims, which each require a pattern of “overlapping beams and non-overlapping beams. We credit Dr. Milner’s uncontroverted testimony that the ordinarily skilled artisan would have understood that a scanner could be used with or instead of a modulator to provide adjustability to one or more lasers, that the artisan would have been familiar with the control and programming of multiple scanners taught in Black, and that the artisan would have been able to implement these features in Hsia’s system without undue experimentation. Ex. 1002 ¶¶ 93, 95, 97, 98. Additionally, we credit Dr. Milner’s uncontroverted testimony that the ordinarily skilled artisan would have found it obvious from the teachings in Black to combine and scan multiple beams into a desired pattern, such as overlapping and non-overlapping in order to optimize treatment results and because the combination would have provided multiple potential benefits. Id. ¶¶ 98, 101, 112, 116, 118–128. We acknowledge Patent Owner’s argument that Dr. Milner’s testimony regarding the ordinary artisan’s motivation to combine references parrots the rationales identified and discussed in the ’481 patent. Prelim. Resp. 36–38. Dr. Milner, however, also cites disclosures in both Hsia and Black citing advantages of combined beams including improved treatment efficacy, improved healing, the ability to treat simultaneously at multiple depths, and reduction in the number of required treatments. Ex. 1002 ¶¶ 117–119. “[T]he motivation-to-combine analysis is a flexible one. Any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Intel Corp. v. PACT XPP Schweiz AG, 61 F.4th 1373, 1379 (Fed. Cir. 2023) (citing KSR Int’l, 550 U.S. at 420 (alterations, emphasis, and internal quotation marks omitted).” slip op. at 21
- Expert testimonyPetitioner expert creditedDecided for petitioner
“Black discloses that its combined beam can be controlled to rotate the mirrors to “generate various different kinds of treatment patterns” and can “create any type of three-dimensional paths and treatment pattern.” See Ex. 1006 ¶¶ 61, 62; Ex. 1002 ¶ 69. On this record and at this stage, the ability to generate treatment patterns meets the limitations of the claims, which each require a pattern of “overlapping beams and non-overlapping beams. We credit Dr. Milner’s uncontroverted testimony that the ordinarily skilled artisan would have understood that a scanner could be used with or instead of a modulator to provide adjustability to one or more lasers, that the artisan would have been familiar with the control and programming of multiple scanners taught in Black, and that the artisan would have been able to implement these features in Hsia’s system without undue experimentation. Ex. 1002 ¶¶ 93, 95, 97, 98. Additionally, we credit Dr. Milner’s uncontroverted testimony that the ordinarily skilled artisan would have found it obvious from the teachings in Black to combine and scan multiple beams into a desired pattern, such as overlapping and non-overlapping in order to optimize treatment results and because the combination would have provided multiple potential benefits. Id. ¶¶ 98, 101, 112, 116, 118–128. We acknowledge Patent Owner’s argument that Dr. Milner’s testimony regarding the ordinary artisan’s motivation to combine references parrots the rationales identified and discussed in the ’481 patent. Prelim. Resp. 36–38. Dr. Milner, however, also cites disclosures in both Hsia and Black citing advantages of combined beams including improved treatment efficacy, improved healing, the ability to treat simultaneously at multiple depths, and reduction in the number of required treatments. Ex. 1002 ¶¶ 117–119. “[T]he motivation-to-combine analysis is a flexible one. Any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Intel Corp. v. PACT XPP Schweiz AG, 61 F.4th 1373, 1379 (Fed. Cir. 2023) (citing KSR Int’l, 550 U.S. at 420 (alterations, emphasis, and internal quotation marks omitted).” slip op. at 21
Claim construction§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 10,675,481 - Vifor (International) AG v. Biofer S.P.A.Institution deniedPTAB · Apr 24, 2023 · IPR2022-01608 · APJ Grace Karaffa Obermann · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–16, 19–21, and 23–25 were unpatentable on any asserted ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsDenied
“step of reacting a sugar with bromine occurs “in a solution at a pH between 7.0 and 9.0.” Ex. 1001, 16:46–47. A dispositive question arises, on this record, as to whether Petitioner’s information, directed to this pH range limitation, is sufficient to support institution of review. For reasons that follow, we determine that Petitioner’s information is not sufficient and deny the Petition on that basis.” slip op. at 9
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable
“and 12 and that Stoll suggests a pH range of 7 or greater. Pet. 29–30 and n.7, 39. Those prior art pH ranges overlap or encompass the specified pH range of “between 7.0 and 9.0.” Pet. 38–39 and n.10. Under these circumstances, the burden of production shifts to Patent Owner to come forward with evidence of the criticality of the specified pH range limitation. See id. at 39–40 (quoting E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1008 (Fed. Cir. 2018). Patent Owner meets that burden by directing us to the Marchi Declaration. Resp. 9–12; Ex. 1004, 432–440. That evidence contains experimental results that support Dr. Marchi’s opinion that the claimed method, when performed at a pH of 8, “can be run with equimolar amounts of oxidant without increasing depolymerization,” but when performed at a pH of 10, results in an undesirable “depolymerizing attack on the main chain, even employing only 0.9 equivalents of oxidant.” Ex. 1004, 434–435 (¶ 7). As Patent Owner points out, moreover, the oxidation reaction in each of the examples in Geisser is carried out at a pH of 10. see Prelim. Resp. 26 and n.8 (citing Ex. 1006, Examples 1–8).” slip op. at 10
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We assess the ground based on anticipation by Geisser in view of the principle that a prior art reference anticipates a patent claim “if it discloses every claim limitation.” In re Montgomery, 677 F.3d 1375, 1379 (Fed. Cir. 2012). The ground based on anticipation by Geisser rests on a conclusory opinion that Geisser’s disclosure of a pH range between 8 and 12 “describes” an oxidation reaction that occurs “at a pH between 7.0 and 9.0.” Pet. 63 (citing Ex. 1002 ¶ 178, which repeats that conclusory opinion verbatim without objective evidence or analysis). It is unclear on this record, and Petitioner does not explain adequately, how or why Geisser anticipates the pH range limitation of claim 1, which is “critical” for reasons explained above in our analysis of the ground based on obviousness over Geisser and Stoll. Ex. 1004, 435 (the Marchi Declaration, ¶ 7). Accordingly, on this record, we determine that Petitioner does not establish a reasonable likelihood of prevailing “with respect to at least [one] of the claims” based on any ground asserted in the Petition. 35 U.S.C. § 314(a).” slip op. at 13
- Skill levelSkill level petitioner adoptedOther
“Petitioner proposes that an ordinarily skilled artisan “would hold an advanced degree, such as an M.S. or doctorate, in chemistry, medicine, pharmacy, or a related degree,” as well as post-graduate experience “in areas of carbohydrate chemistry, synthetic chemistry, medicinal chemistry, inorganic chemistry, and/or metal carbohydrate complexes, or the clinical use of such complexes.” Pet. 16. Patent Owner does not contest Petitioner’s proposed definition in the Preliminary Response. Prelim. Resp. 17–18. 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). To the extent a more precise definition is required, we apply Petitioner’s unopposed proposed definition for purposes of determining whether to institute review because it is consistent with the disclosures of the asserted prior art references.” slip op. at 7
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,759,320 - PTAB · Apr 24, 2023 · IPR2023-00074 · APJ Erica A Franklin · IPR · Institution
The Board instituted IPR on claims 1, 2, 5–8, 11, and 15 on all asserted grounds, finding a reasonable likelihood that claims 1, 2, 5–7, and 11 are obvious over the May Article.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Based on our review of the record, we find that Petitioner has not shown persuasively that the Examiner did not consider the same or substantially the same art that Petitioner relies upon for its obviousness challenges. Petitioner’s grounds primarily rely on three different “May” references, only one of which the Examiner considered during prosecution, i.e., the May Article. The additional primary references relied upon by Petitioner are the May Thesis, which provides a more detailed disclosure than the May Article, and the May Abstract, which provides less detail than the May Article, in terms of the HS2, HS3, and HS4 fragments used to generate the disclosed TNS9 vector. Those differences are only material with respect to whether each reference discloses the fragments as recited in independent claim 1, or renders those fragments obvious. As discussed in Section II.D.2., however, we determine that the May Thesis is not prior art. 11 The ’221 application claims priority to provisional application no. 60/301,861 (Ex. 1034) (“the ’861 provisional application”), filed June 29, 2001, and provisional application no. 60/302,852 (Ex. 1035) (“the ’852 provisional application”), filed on July 2, 2001, referred to, collectively, as “the provisional applications,” “the provisionals” and “the Provisionals.” Article, but in less detail, the May Abstract may be considered cumulative to the May Article. Because the May Thesis provides more explicit details regarding the fragments disclosed in the May Article, it may not be considered to be cumulative to the May Article. However, as discussed in Section II.D.2., we determine that the May Thesis is not prior art. When considering the extent of the overlap between the arguments made during examination and the manner in which Petitioner relies on the May Article or Patent Owner distinguishes the May Article, we note that Patent Owner alleged during prosecution and here that the May Article is not prior art for a number of reasons, including that it is the work of the inventors and that it was published one year or less before the priority date asserted by Patent Owner for the challenged claims. We note also that Petitioner contends that the challenged claims are not entitled to the priority date asserted by Patent Owner, and recognized by the Examiner. Based on the foregoing, we conclude that substantially the same prior art that Petitioner relies upon was previously presented to the Examiner during prosecution. The first part of the § 325(d) framework is, therefore, met. Accordingly, we turn to the second part of the § 325(d) and determine whether error by the Office has been shown. See Advanced Bionics at 8.” slip op. at 10
- Skill levelSkill level petitioner adoptedOther
“Petitioner asserts that a person of ordinary skill in the art (“POSA”) “at the time of the alleged invention would have had: (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, biotechnology, protein chemistry, genetics, molecular and structural biology, bioengineering, or similar disciplines.” Pet. 18–19 (citing Ex. 1002 ¶¶ 14– 15). Petitioner further asserts that a POSA would have had “(2) several years of post-graduate training or related experience in one or more of these areas” and “(3) an understanding of vector design and the effect of LCR fragments on gene expression, including experience with how the LCR regulates gene expression.” Id. At this stage in the proceeding, Patent Owner does not dispute Petitioner’s description of the level of ordinary skill in the art. See Prelim. Resp. Because Petitioner’s uncontested definition of one of ordinary skill in the art is reasonable and consistent with the ’061 patent and the prior art of record, we adopt Petitioner’s definition for purposes of this Decision.” slip op. at 15
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner states that “that no term of the ’061 patent requires construction to resolve the challenges in this Petition.” Pet. 25 (citing Ex. 1002 ¶¶ 50–51) (footnote omitted). Patent Owner does not argue for any express claim constructions. See Prelim. Resp. Based upon our review of the current record, we determine that no claim terms require express construction for purposes of deciding whether to institute an inter partes review of the challenged claims. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (Only those terms that are in controversy need be construed, “and only to the extent necessary to resolve the controversy.”).” slip op. at 16
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Rather, “the 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 Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). Based on our consideration of the arguments and evidence presented at this stage of the proceeding, we determine, for purposes of this Decision, that claims 1, 2, 5–7, and 11 of the ’061 patent are not entitled to receive benefit of the filing date for either the ’861 provisional application or the ’852 provisional application. In particular, we find persuasive Petitioner’s arguments that the provisional applications do not satisfy the written description requirements of 35 U.S.C. § 112 for those claims. Independent claim 1 recites, in part, “a recombinant lentiviral vector which comprises a nucleic acid encoding a functional globin operably linked to a 3.2-kb nucleotide fragment . . . said vector providing expression of the globin in a mammal in vivo.” Ex. 1001, 11:57–67. Independent claim 11 recites, in part, “a recombinant lentiviral vector comprising a nucleic acid encoding a functional globin operably linked to a 3.2-kb nucleotide fragment . . . said vector providing expression of the globin in a mammal in vivo.” Ex. 1001, 12:64–13:7. Based upon our review, we agree with Petitioner that these limitations are not adequately described in the provisional applications. The ’061 patent Specification (and the ’221 Application) describe the term “functional globin gene” as: that does not produce a hemoglobinopathy phenotype, and which is effective to provide therapeutic benefits to an individual with a defective globin gene. The functional globin gene may encode a wild-type globin appropriate for a mammalian individual to be treated, or it may be a mutant form of globin, preferably one which provides for superior properties, for example superior oxygen transport properties. . . . Suitably, the globin may encode α-globin, β-globin, or γ-globin. Ex. 1001, 2:44–55 (emphasis added); see also Ex. 1032, 3:24–4:3 (same). Based on this description, we agree with Petitioner that the ’061 patent claims cover a recombinant vector comprising a nucleic acid encoding a “functional globin” genus that includes wild-type globin and mutant forms of globin, wherein the globin may encode different globin types, i.e., α-, β-, or γ-globin. Patent Owner does not identify, nor do we see, any portion of the provisional applications describing the genus of functional globin. Rather, as Petitioner demonstrates, the provisional applications describe one species of that genus, i.e., the wild-type human β-globin. Pet. 14–18. The provisionals do not describe the “functional globin” genus. Indeed, as Petitioner correctly asserts, during the ’061 patent prosecution, Applicants/Patent Owner, relied on a description of “functional globin,” quoted above, that does not appear and has not counterpart in the provisional applications. Compare Ex. 1001, 2:44–55 and Ex. 1032, 3:24–4:3 with Ex. 1034 and Ex. 1035.” slip op. at 21
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 8,058,061 - PTAB · Apr 24, 2023 · IPR2023-00070 · APJ Erica A Franklin · IPR · Institution
The Board instituted IPR of claims 1, 10, 19, and 22 on all asserted grounds, finding a reasonable likelihood that claim 1 is obvious over the May Article.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“In evaluating matters under § 325(d), the Board uses the following two-part framework: (1) determining whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of the first part of the framework is satisfied, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8.” slip op. at 7
- Skill levelSkill level petitioner adoptedOther
“Petitioner asserts that a person of ordinary skill in the art (“POSA”) “at the time of the alleged invention would have had: (1) at least an advanced degree (e.g., a Master’s or Ph.D.) in biochemistry, biotechnology, protein chemistry, genetics, molecular and structural biology, bioengineering, or similar disciplines.” Pet. 17 (citing Ex. 1002 ¶¶ 14–15). Petitioner further asserts that a POSA would have had “(2) several years of post-graduate training or related experience in one or more of these areas” and “(3) an understanding of vector design and the effect of LCR fragments on gene expression, including experience with how the LCR regulates gene expression.” Id. At this stage in the proceeding, Patent Owner does not dispute Petitioner’s description of the level of ordinary skill in the art. See Prelim. Resp. Because Petitioner’s uncontested definition of one of ordinary skill in record, we adopt Petitioner’s definition for purposes of this Decision.” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner states that “no term of the ’179 patent requires construction to resolve the challenges in this Petition.” Pet. 22 (citing Ex. 1002 ¶¶ 49– 50) (footnote omitted). Patent Owner does not argue for any express claim constructions. See Prelim. Resp. Based upon our review of the current record, we determine that no claim terms require express construction for purposes of deciding whether to institute an inter partes review of the challenged claims. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (Only those terms that are in controversy need be construed, “and only to the extent necessary to resolve the controversy.”).” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“As the Federal Circuit has noted, however, “[i]n order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Rather, “the 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 Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010).” slip op. at 20
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 7,541,179
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.