- PTAB · Mar 24, 2025 · IPR2024-01235 · APJ Hubert C Lorin · IPR · Institution
The Board instituted IPR of claims 1–3, 6–11, and 14–16 on all proposed grounds after finding a reasonable likelihood of prevailing on the §103 ground over Mañosa and Patel.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016), 815 F.3d at 1363 (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). slip op. at 8
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedPrinted publication not establishedMixed
“[T]here is no presumption in favor of institution or in favor of finding a reference to be a printed publication under § 42.108(c) or any other authority. . . . [T]he burden is on the petitioner to identify with particularity evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent, and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” slip op. at 20
- Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageDisclaimer not foundDecided for petitioner
“May” expresses a possibility. The Specification reflects this interpretation of “may” when it states that “[i]n one embodiment, the organic material is not lyotropic. Thus, the organic material may not be a phospholipid.” Ex. 1001, 8:27–28 (emphasis added). One of ordinary skill would understand from this that the organic material “may not be” a phospholipid if the organic material is not lyotropic. It follows that if the organic material is lyotropic, then the organic material may be a phospholipid. Reading the statement “[t]he organic material may not be . . . a phospholipid” (id. at 8:59–63) in light of the earlier stated possibility that the organic material may be a phospholipid if the organic material is lyotropic, one of ordinary skill in the art would interpret “may not be” as excluding phospholipids under some conditions, not under all conditions. Taking the Specification’s discussion about phospholipids as exemplifying the permissive nature of the word “may,” we are unpersuaded that in stating that “[t]he organic material may not be [PMMA], a polyvinylidene difluoride-containing polymer, such as [PVDF] or PVDF- TrFE-CTFE, or a phospholipid, such as [DHPE]’” (Ex. 1001, 8:59–63), the specification “contains a clear and unmistakable disavowal of the compounds PMMA, PVDF, PVDF-TrFE-CTFE, and DHPE” and “disclaims the listed compounds” from the “organic material” of the claims under all conditions, as Patent Owner argues. Prelim. Resp. 6–7. Moreover, the claims themselves limit the “organic material” only to the extent that it is “barocaloric cooling or heating agent” and can perform in the manner claimed. See Ex. 1001, claim 1, supra. As broadly worded, the claims do not exclude PMMA, PVDF, PVDF-TrFE-CTFE, and DHPE per se from the group of organic materials employed by the claimed method. Adopting Patent Owner’s construction would impermissibly import a limitation (i.e., not exclude PMMA, PVDF, PVDF-TrFE-CTFE, and DHPE) into the claims. For the reasons stated, at this stage of the proceeding, we agree with Petitioner’s broad construction of “organic material.” We do not adopt Patent Owner’s proposed construction whereby PMMA, PVDF, PVDF- TrFE-CTFE, and DHPE are excluded from the scope of the claim term “organic material.” The parties are invited to address this issue further during trial, if desired. slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Petitioner shows that (a) Mañosa (i.e., inorganic compounds such as Ni-Mn-In, Gd5Si2Ge2, and La-Fe-Co-Si) and (b) Patel (i.e., PVDF-TrFE- CTFE) teach materials exhibiting inverse BCEs. Pet. 59 (citing, inter alia, Ex. 1007, pages 4–8; Ex. 1009, 1, 4–5; Ex. 1004 ¶ 108). In our view, at this stage, Petitioner sufficiently shows (via the five reasons listed supra) why it would have been obvious to one of ordinary skill in the art to substitute the barocaloric cooling or heating agent of Patel for that taught in Mañosa, thereby reaching the claimed method with a reasonable expectation of success. Cf. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (U.S., 2007) (“The Court recognized that when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.”)” slip op. at 32
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,230,656 - Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentablePTAB · Jun 13, 2024 · IPR2022-01600 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–20 are unpatentable as obvious: claims 1–7 and 9–20 over Olmos and Varela ’774, and claim 8 over Olmos, Varela ’774, and Oglaza.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“invention. Graham, 383 U.S. at 17–18. Petitioner contends that a person of ordinary skill in the art (sometimes abbreviated herein as “POSITA”): would have had a bachelor’s degree in mechanical engineering or biomedical engineering and two or more years of experience in biomechanical engineering, biomedical engineering, and/or spinal implant devices. A person could also have qualified as a POSITA with some combination of more formal education (e.g., an M.D.) and less technical experience or less formal education and more technical or professional experience in the foregoing fields, and would have had further appreciation of various technical concepts in this field. Pet. 18 (citing Ex. 1002 ¶¶ 32–35). Patent Owner does not dispute Petitioner’s proposal. See Response 8. We adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the cited prior art and is undisputed. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 13
- Expert testimonyPetitioner expert creditedPatent owner expert discountedMixed
“We credit Mr. Drewry’s testimony that it would have been well within the ordinary skill of a POSITA to make the proposed modifications. See Ex. 1002 (Drewry Decl.) ¶¶ 34, 56–71 (discussing the qualifications of a POSITA and the types of engineering concepts the POSITA would have understood); Ex. 1030 (Drewry Reply Decl.) ¶¶ 37, 48–56, 59–66. To the extent Mr. Culbert testifies otherwise, we do not find such testimony persuasive. Indeed, Olmos itself further supports Mr. Drewry’s testimony that a POSITA would have known how to modify dimensions to fit specific needs and make changes necessary to adapt features from one embodiment to fit another. See Ex. 1006 (Olmos) ¶¶ 153, 188 (providing a range of implant sizes and noting that “specific dimensions” of any disclosed 9 Patent Owner’s citation to Mr. Drewry’s deposition transcript at 87:13– 88:9 appears to be incorrect. We understand that the intended citation is 69:34–70:7. embodiment can be varied as is apparent to a POSITA and “all features discussed in connection with any one embodiment herein can be readily adapted for use in other embodiments herein to form various combinations and sub-combinations”). Given the POSITA’s ability to make the proposed modifications, we do not find that Patent Owner’s evidence regarding the number of modifications required undermines Petitioner’s articulated reasoning for the combination.” slip op. at 35
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that “no terms require constructions differing from their plain and ordinary meaning.” Pet. 19. Patent Owner states that it “takes no position on Petitioner’s assertion because the Board need not construe any claim term to find that the Challenged Claims are not unpatentable.” Response 8. We find that for purposes of this Decision, we need not construe any claim term. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe 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))).” slip op. at 21
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
Patent outcomesUS 10,973,649 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,973,649 - Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentablePTAB · Apr 18, 2024 · IPR2022-01435 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–11 are unpatentable: Chung anticipates claim 10, and the Olmos-based obviousness grounds establish unpatentability of claims 1–11.
RulingsFinal written decision- Skill levelOther
“B. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 11
- Strike new argumentNew argument consideredDenied
“9 Patent Owner asserts that Petitioner’s Reply brief “presents copious new evidence and theories that exceed the scope of proper reply” and “[t]he Board should refuse to consider” it. Sur-reply 7–9. This generic objection to the entire Reply fails to provide adequate notice regarding which of Petitioner’s theories and arguments Patent Owner contends are allegedly new and improper. See, e.g., Rembrandt Diagnostics, LP v. Alere, Inc., 76 F.4th 1376, 1383 (Fed. Cir. 2023) (rejecting generic objection to alleged new theories in reply as failing to provide adequate notice of which theories are allegedly new). Accordingly, we reject Patent Owner’s request that we “refuse to consider” the entirety of the Reply. Where Patent Owner’s Sur-reply raises more particularized complaints regarding Petitioner’s allegedly improper new arguments, we address those complaints as appropriate below.” slip op. at 20
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningOther
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“Accordingly, we find Petitioner has not shown that claim 1 is unpatentable as anticipated by Chung.” slip op. at 65
Patent outcomesUS 10,137,001 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,137,001 - Draftkings Inc., A Delaware Corporation v. AG 18, LLCSome claims unpatentablePTAB · Mar 12, 2024 · IPR2022-01446 · APJ George R Hoskins · IPR · Final written decision
Claims 1–17 and 19–30 are unpatentable based on the listed anticipation and obviousness grounds; claim 18 was not shown unpatentable.
RulingsFinal written decision- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesTerm construed petitioner constructionDecided for petitioner
“Module Terms each recite a “module” that is configured to perform or to oversee certain recited functionality, without reciting sufficient structure for performing that functionality. See Pet. 32. Further, as in Williamson, the word “module” in the context of the ’205 patent claims and specification is a “nonce” word, used “in a manner that is tantamount to using the word ‘means.’” Williamson, 792 F.3d at 1350–51. We therefore agree with Petitioner’s position that the rebuttable presumption against application of § 112 ¶ 6 is overcome in this case, because the Module Terms are not understood by persons of ordinary skill in the art to have a sufficiently definite meaning as the name for structure. See Williamson, 792 F.2d at 1349 (“The standard is whether the words of the claim are understood by persons of ordinary skill in the art to have a sufficiently definite meaning as the name for structure.”). Patent Owner’s and Dr. Lane’s apparent disagreement with this conclusion in the context of the ’205 patent is unaccompanied by any argument seeking to establish that the Module Terms might be understood to recite a sufficiently definite meaning as the name for structure. See PO Resp. 6; Ex. 2005 ¶ 28.” slip op. at 55
- ExcludeMotion to exclude, deniedDenied
“Petitioner filed a Motion to Exclude Evidence proffered by Patent Owner (Paper 31). Patent Owner filed an Opposition (Paper 32), and Petitioner filed a Reply (Paper 33). We deny Petitioner’s Motion to Exclude Evidence, for reasons provided below.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“k) Conclusion Regarding Claim 12 Thus, based on the record presented, we conclude Petitioner has” slip op. at 32
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed
“Petitioner relies on Bryson as disclosing the subject matter recited in claim 1, except for limitations 1[g] and 1[h], in substantially similar fashion as discussed above in Ground One in relation to other claims. See Pet. 68–73. Patent Owner’s sole opposition in this regard is whether Bryson discloses the betting range limitation 1[j]. See PO Resp. 49–53 (Patent Owner’s opposition to Ground Four as to claim 1). We conclude a preponderance of the evidence establishes Bryson supports Petitioner’s unopposed contentions in this regard, for the reasons set forth in the Petition which we adopt as our own in this Decision. We accordingly find Bryson discloses the preamble 1[pre] and limitations 1[a]–1[f], 1[i], and 1[k]–1[m].” slip op. at 74
Patent outcomesUS 9,978,205 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,978,205 - Draftkings Inc. v. AG 18, LLCSome claims unpatentablePTAB · Mar 12, 2024 · IPR2022-01448 · APJ Frances L Ippolito · IPR · Final written decision
Claims 1–10 and 12–29 are unpatentable over the asserted anticipation and obviousness grounds; claim 11 was not shown unpatentable.
RulingsFinal written decision- Skill levelOther
“B. Level of Ordinary Skill in the Art In determining the level of skill in the art, we consider the type of” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningOther
“C. Claim Construction In an inter partes review, we construe each claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” 37 C.F.R. § 42.100(b). Accordingly, our claim construction standard is the same as that of a district court. See id. Under the standard applied by district courts, claim terms are generally given their plain and ordinary meaning as would have been understood by a person of ordinary skill in the art at the time of the invention and in the context of the entire patent disclosure. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). “There are only two exceptions to this general rule: 1) when a patentee sets out a definition and acts as his own lexicographer, or 2) when the patentee disavows the full scope of a claim term either in the specification or during prosecution.” Thorner v. Sony Comput. Entm’t Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012).” slip op. at 11
- Claim Construction › Functional claiming / §112(f) means-plus-function › Whether §112(f) applies (Williamson, nonce words)§112(f) appliesTerm construed petitioner constructionDecided for petitioner
“generally takes issue with whether Petitioner has sufficiently explained its construction of means-plus-function limitations. See PO Resp. 24–35. Nonetheless, based on the complete record, we find that the Petition “identif[ies] the specific portions of the specification that describe the structure, material, or acts corresponding to each claimed function” of this means-plus-function limitation in claim 26. 37 C.F.R. § 42.104(b)(3); see Pet. 22 (citing Ex. 1001, 3:60–66). Moreover, we apply Petitioner’s construction for our prior-art analysis because it is consistent with and supported by the complete record.” slip op. at 38
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“9–11, 20 102(e) Bryson 9, 10 11” slip op. at 110
Patent outcomesUS 10,614,657 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,614,657 - C.R. Bard, Inc. v. Medline Industries, Inc.Some claims unpatentablePTAB · Nov 23, 2022 · IPR2019-00035 · APJ Mitchell G Weatherly · IPR · Remand
Claims 1, 2, 6, 8–10, 16, 25–27, 29–37, and 39–44 are unpatentable as obvious; claims 7, 17–19, 28, and 38 were not shown unpatentable.
RulingsRemand decision- PTAB / AIA Trials › §315(e) estoppelEstoppel does not applyDecided for patent owner
“IPR2019-00208 and this proceeding do not involve an “identical issue” despite Patent Owner relying on essentially the same body of objective evidence of nonobviousness in both proceedings. The challenged claims in this proceeding materially differ from those at issue in IPR2019- 00208. Compare Ex. 1001, 27:47–30:57, with IPR2019-00208, Ex. 1001, 11:47–12:28; see also PO Remand Br. 23. The material differences in the claims, alone, and thus the issues previously decided, precludes a finding of collateral estoppel. Therefore, we conclude that Patent Owner is not collaterally estopped from relying upon its objective evidence of nonobviousness. Rather, we consider and weigh that evidence as it applies to the claims at issue in this proceeding below.” slip op. at 54
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“However, we disagree with Patent Owner’s interpretation of limitation 1a as requiring that the compartment for receiving the medical assembly be “distinct” from the first compartment or that the medical assembly be disposed within the “compartment” of limitation 1a. Limitation 1f requires “at least two compartments,” but expressly recites a functional limitation for only “a first compartment” among the “at least two compartments.” Ex. 1001, 27:60–62. Claim 1 does not further limit the unspecified compartment among the “at least two compartments” or specify what items, if any, are placed within it. See id. at 27:47–67. Two unchallenged dependent claims, claims 4 and 11, further recite that “the at least two compartments” further comprise “a second compartment.” Claim 4 depends directly from claim 1 and further recites, in pertinent part: “the at least two compartments further comprising a second compartment separated from the first compartment by a wall with an opening, further comprising a catheter assembly disposed within the second compartment, the catheter assembly comprising a fluid bag.” Id. at 28:21–25 (emphasis added). Claim 11 depends from claim 10, which depends from claim 1, and similarly recites: “the at least two compartments further comprising a second compartment separated from the first compartment by a wall with an opening, further comprising a catheter assembly disposed within the second compartment.” Id. at 28:47–51 (emphasis added).” slip op. at 18
- Skill levelSkill level board ownDecided for petitioner
“skill in the relevant art would have a bachelor’s degree in packaging engineering, mechanical engineering, or industrial design. Pet. 18 (citing Ex. 1002 ¶¶ 14–16); PO Resp. 15 (citing Ex. 2026 ¶ 38). Alternatively, such a person could have an engineering degree in another technical field along with about two years of experience designing medical packaging. Pet. 18 (citing Ex. 1002 ¶¶ 14–16); PO Resp. 15 (citing Ex. 2026 ¶ 38). Neither party contends that a person of ordinary skill needs to be a medical practitioner, but both parties agree that the person of ordinary skill would consult with medical practitioners familiar with catheterization procedures. Pet. 18; PO Resp. 15 (citing Ex. 2027 ¶ 78). Slight differences exist in the formulation of the level of ordinary skill between the parties. We, however, discern no meaningful difference because none of those differences would affect the outcome of our analysis. Accordingly, we apply the level of skill set forth in the preceding paragraph.” slip op. at 10
- Expert testimonyPatent owner expert creditedPetitioner expert creditedMixed
“Petitioner argues that shallow area 11B “facilitates easy lubrication of the catheter” simply because it is shallow and “it was well-known to ‘(a) apply lubricant directly on the catheter; and (b) use the same compartment where lubricant is stored to lubricate the catheter.’” Pet. Remand Br. 28–29 (citing Pet. 32, 34; Ex. 1002 ¶ 231). Patent Owner persuasively responds, however, that a practitioner would not use the same compartment to collect urine and lubricate the catheter because the lubricant would contaminate the urine specimen collected in the compartment. PO Remand Br. 3–4 (citing PO Resp. 36; Op. *8); see also Ex. 2027 ¶ 175 (Ms. Chiappetta testifying that “lubrication in the portion of the tray that collects urine will contaminate the urine,” which would invalidate any testing of the patient’s urine). Although it may be easier to lubricate a catheter in shallow area 11B than in deep area 11A, we find that Solazzo’s shallow area 11B is not well-suited, configured, or intended for lubricating a catheter; rather, Solazzo recommends using lubricating wells 31 and 33 for that purpose. We credit Ms. Chiappetta’s supporting testimony to that effect. See Ex. 2027 ¶ 175. Accordingly, we conclude that Petitioner has failed to prove by a preponderance of evidence that the combined teachings of Solazzo and Serany render claim 7 unpatentable as obvious.” slip op. at 31
Patent outcomesUS 9,745,088 mixedClaim construction§ 103 obviousnesscites GrahamPatents in suitUS 9,745,088 - Incyte Corporation v. Concert Pharmaceuticals, Inc.No claims unpatentablePTAB · May 11, 2022 · PGR2021-00006 · APJ Devon Zastrow Newman · PGR · Final written decision
The Board held claims 1–7 and 9–21 not shown unpatentable over either obviousness ground because Petitioner did not establish motivation to select Compound (I) from Silverman’s genus.
RulingsFinal written decision- Expert testimonyPetitioner expert discountedOther
“It is not necessary for an expert’s experience or expertise to precisely match the art at issue. SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1373 (Fed. Cir. 2010). However, one offering expert testimony must at least have ordinary skill in the art to provide relevant and reliable testimony that is helpful to the factfinder. Kyocera Senco Indus. Tools, Inc. v. ITC, 22 F.4th 1369, 1376–77 (Fed. Cir. 2022). “The Board has broad discretion to assign weight to be accorded expert testimony.” Consolidated Trial Practice Guide 35 (available at https://www.uspto.gov/sites/default/files/documents/ tpgnov.pdf?MURL=). Dr. Patterson has a Ph.D. in Chemistry and over 30 years of experience in drug design, drug administration, evaluation of drug effectiveness, and participated in drug design for over 20 years. Ex. 1007 ¶¶ 4–10; Ex. 1008, 1–2. He is author or co-author on over eight peer-reviewed journal articles involving medicinal chemistry. Ex. 1007 ¶ 5. We find this level of skill to meet the qualifications for the level of skill in the art under the training and experience portion of the definition we have adopted for purposes of this opinion (see § II.B.), reproduced below: a Ph.D. in chemistry, pharmaceutical sciences, molecular biology, or a similar field, or an M.D. with similar background. A POSA would also have had at least several years of experience with drug design, drug development, clinical trials, or access to other individuals with that knowledge and experience. Likewise, a POSA would have had knowledge and experience in treating hair loss disorders, or access to a person with that knowledge and experience. We note that Dr. Patterson himself also proposes this definition. Id. ¶ 102. However, Dr. Patterson does not have “knowledge and experience in treating hair loss disorders” and did not opine that, in regards to his testimony, he had access to a person with that knowledge and experience, as is proposed in the definition. See generally, Ex. 1007. Accordingly, we find Dr. Patterson qualified to opine on the level of ordinary skill with regard to issues of drug design, evaluation of effectiveness, and drug administration, but we find he is not adequately qualified to opine on the level of ordinary skill with regard to issues of treating hair loss disorders.” slip op. at 7
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner proposes the same definition as Petitioner, but adds that the skilled artisan “would also have had experience in JAK inhibition, deuteration, and AA [alopecia areata] formulations, or access to a person with that knowledge and experience.” Resp. 15 (citing Ex. 2059 ¶ 14). Patent Owner’s expert Dr. Ko critiques Petitioner’s proposed definition as “incomplete, because it lacks any requirement for experience, or access to individuals with experience, in JAK inhibition, deuteration, and AA formulations.” Ex. 2059 ¶ 16. However, neither Dr. Ko nor Patent Owner explains what difference this additional direct experience would have provided to an artisan with the skill level proposed by Petitioner, particularly when Petitioner’s definition includes “experience in treating hair loss disorders,” and for which the record contains evidence that existing JAK inhibitors such as ruxolitinib had been identified as causing reversal of hair loss caused by AA. Ex. 1003, 1043. Accordingly, we adopt Petitioner’s proposed definition as consistent with the level of skill apparent in the cited prior art. In any event, as Patent Owner does not explain why its alternative definition would have any bearing on the outcome of the present case, and as we discern no appreciable difference in the parties’ definitions, we note our findings and conclusions would be the same regardless of which definition were adopted. We further note that the prior art itself demonstrates 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) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction We construe claims using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. § 282(b). 37 C.F.R. § 42.100. Therefore, we construe the challenged claims under the framework set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc). Under this framework, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art (“POSA”), at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id. Only those terms that are in controversy need be construed and only to the extent necessary to resolve the controversy. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). We have considered Petitioner’s claim construction proposals (see Pet. 21–23), which are uncontested (see generally Resp., not addressing construction), and find that it is not necessary to expressly construe any claim term for purposes of rendering this Decision.” slip op. at 13
- Novelty / Anticipation (§102) › Prior-art status of a reference › Applicant-admitted prior artReference not prior artDecided for patent owner
“Section 102(b)(1) provides two exceptions to § 102(a)(1) for disclosures made within one year of the effective filing date. Specifically, 35 U.S.C. § 102(b)(1) provides that a disclosure made one year or less before the effective filing date of a claimed invention shall not be prior art under 35 U.S.C. § 102(a)(1) with respect to the claimed invention if: (A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or (B) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor. 35 U.S.C. § 102(b)(1).” slip op. at 16
Patent outcomesUS 10,561,659 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,561,659 - Hamilton Technologies LLC v. Fleur TehraniAll claims unpatentablePTAB · Dec 28, 2021 · IPR2020-01199 · APJ Kevin W Cherry · IPR · Final written decision
Claims 1–6, 9–12, 29–33, and 41 are unpatentable as obvious over the Carmichael-Anderson and Taube-based combinations; the Carmichael anticipation ground was not proven.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedDecided for petitioner
“We do not agree with Patent Owner that Dr. Imbruce’s testimony should be disregarded. With respect to Patent Owner’s contentions about “technically erroneous disclosures” and the construction of “for a next breath,” those are really about Patent Owner’s disagreements about those matters, not whether Dr. Imbruce was attempting to mislead the Board. Disagreement between the experts is not a basis for disregarding testimony. We have also reviewed the entirety of Dr. Imbruce’s deposition, and, in particular, the various parts identified by Patent Owner. PO Resp. 76–77. And, contrary to Patent Owner’s assertions, we found Dr. Imbruce gave detailed answers in response to Patent Owner’s questions. We found Dr. Imbruce’s testimony to be adequate. See, e.g., Ex. 2016, 107:11–115:8 (discussion of Anderson references, explaining the similarities of the references, but declining to vouch for data he has not seen or collected); 115:9–116:6 (FDA permission, offering to confirm what reference said about FDA approval, but attorney moving on to other questions). Thus, we do not find Dr. Imbruce’s behavior during cross examination as a reason to give no weight to the entirety of his testimony.” slip op. at 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“(i) a medically trained physician or clinician specializing in treating respiratory failure issues with at least five years of practical clinical ventilator experience treating such conditions; or (ii) a Master’s degree in Electrical Engineering or a related field and about five years of practical experience with developing ventilators for clinical patient treatment; or (iii) a Bachelor’s degree in Electrical Engineering or a related field and about 10 years of practical experience with developing ventilators for clinical patient treatment. Pet. 20‒21 (referencing Ex. 1002 ¶¶ 71‒72). Petitioner proposes that “[a] higher level of education or specific skill might compensate less experience, and vice versa.” Id. at 21. Patent Owner does not present an opposing view of the level of skill of the hypothetical person having ordinary skill in the art of the ’571 patent. See PO Resp. passim. For the purposes of this Decision, we apply Petitioner’s definition of the level of ordinary skill in the art. We determine that this definition is consistent with the prior art of record and the skill reflected in the Specification of the ’571 patent, based on our review of the record.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“In our Institution Decision, we determined that only the claim terms “first means” and “second means” required construction. Inst. Dec. 25–27. Neither party disputes those constructions and we maintain and adopt them for the purposes of this Decision. We determine that, for purposes of this decision, no other terms require express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe 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))).” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We agree with Patent Owner that Carmichael lacks adequate disclosure to anticipate the apparatus of claim 1. Specifically, because Carmichael focuses on the result of physician surveys, and not on the description of a ventilation system per se, Carmichael lacks details as to the specific manner in which the assist control mode was being used to control PEEP and FIO2 levels. Specifically, we cannot discern that Carmichael’s discussion of an assist control mode for mechanical ventilation necessarily entails adjustments to FIO2 and PEEP “for a next breath of the patient” as recited in claim 1. As explained by Patent Owner, it is possible that the parameters of PEEP and FIO2 could have been set manually by the physician and/or could have been updated only periodically during treatment. See, e.g., PO Resp. 25‒26. Thus, Petitioner has not shown by a preponderance of evidence that Carmichael anticipates claim 1, or claims 2, 5, 6, and 11 that depend from claim 1.” slip op. at 20
Patent outcomesUS 7,802,571 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,802,571 - Sotera Wireless, Inc. v. Masimo CorporationAll claims unpatentablePTAB · Nov 19, 2021 · IPR2020-01019 · APJ Jennifer Meyer Chagnon · IPR · Final written decision
Claims 1–25 are unpatentable as obvious over Saidara and Malangi, with claims 3–5, 10–12, 14, 16–17, and 24 also obvious over Saidara, Malangi, and Hickle; Baker-1 grounds were not reached.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“embodiment of the claimed invention includes suspension of an activated alarm and no disclosed embodiment includes parameter-specific pre-alarm delays. Based on the overwhelming and clear disclosure in the Specification of the RE353 patent, we agree with Petitioner that “the correct construction—the construction that most accurately delineates the scope of the claimed invention” requires suspension of an activated alarm, and precludes delays or suspensions that occur before activation of an alarm, i.e., pre-alarm delays. See PPC Broadband, Inc. v. Corning Optical Comm’ns RF, LLC, 815 F.3d 734, 740–42 (Fed. Cir. 2016). We recognize that we do not import limitations from the Specification into the claims. Thorner, 669 F.3d at 1366–67 (“We do not read limitations from the specification into claims.”). It is indisputable, however, that claims must be interpreted in light of the Specification of which they are a part. Phillips, 415 F.3d at 1315–1316. This is because the claims “do not stand alone. Rather, they are part of ‘a fully integrated written instrument,’ consisting principally of a specification that concludes with the claims. For that reason, claims ‘must be read in view of the specification, of which they are a part.’” Id. As the Court of Appeals for the Federal Circuit has stated, “the specification is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.” Vitrionics Corp. v. Conceptronic, Inc., 90 F.3d 1576,” slip op. at 25
- Skill levelSkill level petitioner adoptedDecided for petitioner
“understanding of a person of ordinary skill in the art at the time of the invention. Graham, 383 U.S. at 17. Petitioner contends that a person having ordinary skill in the art “would have been a person with at least a B.S. degree in electrical or biomedical engineering or a related field with at least two years’ experience designing patient monitoring systems,” wherein “[l]ess work experience may be compensated by a higher level of education, and vice versa.” Pet. 13 (citing Ex. 1003 ¶¶ 33–41); see Ex. 1040 ¶ 28. Patent Owner applies the level of ordinary skill in the art identified by Petitioner. PO Resp. 8 n.5 (citing Ex. 2011 ¶¶ 18–19). We adopt Petitioner’s assessment, which appears consistent with the level of skill reflected in the Specification and prior art.” slip op. at 12
- Expert testimonyPatent owner expert discountedDecided for patent owner
“Sur-reply 4–5. We recognize Mr. Goldberg’s testimony that, “in reading the patent as a whole, I believe that pre-alarm delays are, in fact, disclosed.” Ex. 1042, 118:2–13. When pressed to show support in the Specification, however, Mr. Goldberg pointed, first, to the disclosed “other suspend initiator” and, second, to the disclosed alarm suspend firmware that, he contends, “implies . . . a[n] ability to suspend the alarm other than by the alarm silence [button].” See id. at 118:20–123:4 (pointing to Ex. 1001, 4:60–63, 5:37, Figs. 2, 4). We do not find this testimony or Patent Owner’s argument persuasive. First, that the claimed system could suspend the alarm in a manner other than the described silence button (i.e., with the “other suspend initiator”), does not alter the fact that the Specification only discloses suspending an alarm after it has been activated. Second, the firmware upon which Mr. Goldberg relies is disclosed as “respond[ing] to an alarm silence button press 288.” Ex. 1001, 5:38–41. Accordingly, we give little weight to Mr. Goldberg’s conclusory testimony that pre-alarm delays are disclosed, because this testimony is unsupported by any persuasive cited evidence. See 37 C.F.R. § 42.65(a).” slip op. at 28
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundNot shown unpatentableMixed
“The Petition provides limited guidance in this regard. Petitioner contends that it would have been obvious to also monitor blood pressure with Saidara’s device, as taught by Malangi, and provides reasons why such a modification would have been desirable. Pet. 68. Even accepting these reasons, for the sake of argument, the Petition is silent as to how a skilled artisan would have implemented Malangi’s teachings in Saidara. Id. at 67– 69. In its Reply, Petitioner cites testimony that is insufficient to support its contentions. For example, Petitioner relies upon the testimony of its expert, Dr. Bergeron, that a person of ordinary skill in the art “understood how [to] measure blood pressure.” Ex. 1040 ¶ 109; Pet. Reply 23. Petitioner also relies on the testimony of Patent Owner’s expert, Mr. Goldberg, that blood pressure cuffs were prevalent. Ex. 1042, 45:18–46:7; Pet. Reply 23. Both points may well be true. However, neither Petitioner, nor the cited expert testimony, explains persuasively how a skilled artisan would have known how to integrate Malangi’s teaching of monitoring and alarming for blood pressure (whether using a prevalent and well-known blood pressure cuff or any other device) with Saidara’s particular system, nor do they discuss the detriments or benefits of such a modification, e.g., the increased size and complexity of incorporating a blood pressure cuff into Saidara’s device. It is Petitioner’s burden to do so. It is insufficient to merely establish that it was known to use blood pressure cuffs to monitor that parameter.14 For the foregoing reasons, we agree with Patent Owner that Petitioner fails to explain sufficiently how a person of ordinary skill in the art would have modified Saidara to also monitor, alarm, and delay alarms for blood pressure, and leaves it to the Board to piece together the proposed modification. PO Resp. 61–62; but see Pet. Reply 25, and Ex. 1040 ¶¶ 109– 111 (explaining how, apart from blood pressure monitoring, SpO2 monitoring and alarming would have been achieved in the combination).” slip op. at 44
Patent outcomesUS RE47,353 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · Graham - Sotera Wireless, Inc. v. Masimo CorporationAll claims unpatentablePTAB · Nov 19, 2021 · IPR2020-01033 · APJ Amanda F Wieker · IPR · Final written decision
Claims 1–24 are unpatentable; claims 1–24 are shown unpatentable over Saidara and Malangi, with specified dependent claims also obvious over combinations including Hickle.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Analysis Contrary to Patent Owner’s assertions, we find that every disclosed embodiment of the claimed invention includes suspension of an activated alarm and no disclosed embodiment includes parameter-specific pre-alarm delays. Based on the overwhelming and clear disclosure in the Specification of the ’249 patent, we agree with Petitioner that “the correct construction— the construction that most accurately delineates the scope of the claimed invention,” requires suspending or holding an activated alarm, and precludes holds or suspensions that occur before activation of an alarm, i.e., pre-alarm delays. See PPC Broadband, Inc. v. Corning Optical Comm’ns RF, LLC, 815 F.3d 734, 740–42 (Fed. Cir. 2016).” slip op. at 21
- Skill levelSkill level petitioner adoptedDecided for petitioner
“understanding of a person of ordinary skill in the art at the time of the invention. Graham, 383 U.S. at 17. Petitioner contends that a person of ordinary skill in the art “would have been a person with at least a B.S. degree in electrical or biomedical engineering or a related field with at least two years’ experience designing patient monitoring systems,” wherein “[l]ess work experience may be compensated by a higher level of education, and vice versa.” Pet. 13 (citing Ex. 1003 ¶¶ 33–41). Patent Owner applies the level of ordinary skill in the art identified by Petitioner. PO Resp. 9 n.5 (citing Ex. 2011 ¶¶ 18–19). We adopt Petitioner’s assessment, which appears consistent with the level of skill reflected in the Specification and prior art.” slip op. at 28
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundMotivation foundMixed
“As an initial matter, we agree with Patent Owner’s arguments about the proposed modification of Saidara to include blood pressure monitoring and alarming. Primarily, we agree that Petitioner fails to meet its burden of explaining how a person of ordinary skill in the art would have incorporated Malangi’s teaching of blood pressure monitoring and alarming with Saidara’s device. PO Resp. 55–56, 62–63. The Petition provides limited guidance in this regard. Petitioner contends that it would have been obvious to also monitor blood pressure with Saidara’s device, as taught by Malangi, and provides reasons why such a modification would have been desirable. Pet. 68. Even accepting these reasons, for the sake of argument, the Petition is silent as to how a skilled artisan would have implemented Malangi’s teachings in Saidara. Id. at 67– 69. In its Reply, Petitioner cites testimony that is insufficient to support its contentions. For example, Petitioner relies upon the testimony of its expert, Dr. Bergeron, that a person of ordinary skill in the art “understood how [to] measure blood pressure.” Ex. 1040 ¶ 113; Pet. Reply 23. Petitioner also relies on the testimony of Patent Owner’s expert, Mr. Goldberg, that blood pressure cuffs were prevalent. Ex. 1042, 45:18–46:7; Pet. Reply 23. Both points may well be true. However, neither Petitioner, nor the cited expert testimony, explains persuasively how a skilled artisan would have known how to integrate Malangi’s teaching of monitoring and alarming for blood pressure (whether using a prevalent and well-known blood pressure cuff or any other device) with Saidara’s particular system, nor do they discuss the detriments or benefits of such a modification, e.g., the increased size and complexity of incorporating a blood pressure cuff into Saidara’s device. It is Petitioner’s burden to do so. It is insufficient to merely establish that it was known to use blood pressure cuffs to monitor that parameter.13 For the foregoing reasons, we agree with Patent Owner that Petitioner” slip op. at 43
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
Patent outcomesUS RE47,249 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · Graham
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.