- 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.All claims unpatentablePTAB · May 24, 2023 · IPR2022-00335 · APJ Michael L Woods · IPR · Final written decision
Claims 26–28 and 31 are unpatentable; proposed substitute claims 32–35 are also unpatentable, so the revised motion to amend is denied.
RulingsFinal written decision- BurdenDecided for patent owner
“Accordingly, even in the absence of any argument from Patent Owner,” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“2. Claim 26 Claim 26 recites “[a] method for repairing a sacroiliac joint.” Ex.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableUnpatentable
“2. Combination of Stark and Stoffman In presenting this alternative challenge and combining Stark with” slip op. at 38
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied
“Accordingly, Petitioner has shown, by a preponderance of the” slip op. at 87
Patent outcomesUS 10,426,539 unpatentable§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham · NautilusPatents in suitUS 10,426,539 - 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 - Restem, LLC. v. Jadi Cell, LLCNo claims unpatentablePTAB · Apr 18, 2023 · IPR2021-01535 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–15 were not proven unpatentable: Majore did not anticipate claims 1–13 and 15, and the asserted obviousness combinations did not establish the claimed limitations.
RulingsFinal written decision- Expert testimonyPetitioner expert discountedDecided for patent owner
“Ex. 1007 ¶¶ 132, 133. Importantly, however, Dr. Olson does not cite anything to support his opinion that the ordinary artisan would have known that MSCs could be cultured to be renewable from subepithelial UC tissue. Nor does Dr. Olson explain why the artisan would have had this understanding aside from simply stating it. Majore uses the word “subepithelial” only once to explain that primitive stem cells are “distributed in subepithelial and intervascular regions,” but this does not teach what Dr. Olson asserts. Accordingly, Dr. Olson’s testimony is entitled to little weight. Xerox Corp., IPR2022-00624, Paper 9 at 15–16 (finding that an expert’s conclusory assertions that repeat the proposition for which they are offered without “any additional supporting evidence or provide any technical reasoning” in support are “conclusory and unsupported, add[] little to the conclusory assertion[s] for which [they are] offered to support, and is” slip op. at 52
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“21 The parties do not dispute that the preamble’s recitation of “isolated cell” serves as a limitation to claim 1 as it provides antecedent basis for its recitation later in the body of the claim. Accordingly, we treat the preamble as limiting. “When limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention.” See Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003).” slip op. at 31
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“[JUDGE NEWMAN:] So if -- if the comparison is possible, why did you not present evidence of that comparison? MR. FITZPATRICK: We --we’ve had the -- we had this discussion with our -- with our expert, and our conclusion was that it’s just not -- it wasn’t necessary. The conclusion was that the -- the evidence that’s in the -- in the prior art references, including the fact that it clearly practices the exact same steps as the claims, that was sufficient to -- and would anticipate or render obvious the claims. That’s the only reason we didn’t present evidence -- our own evidence.” slip op. at 38
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“Ex. 1007 ¶ 168 (alteration in original). We agree that an ordinary artisan would be motivated to look to the teachings of analogous references for information, but to establish obviousness, a party must show that “there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (requiring “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness”)). Petitioner has not provided sufficient rationale to explain why the ordinary artisan would have been motivated to make the isolated cell with the specific marker profile or why the artisan would have looked to the cited references themselves out of the wide range of references available in the art.” slip op. at 64
Patent outcomesUS 9,803,176 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,803,176 - PTAB · Mar 30, 2023 · IPR2023-00026 · APJ Grace Karaffa Obermann · IPR · Institution
The Board instituted IPR of claims 1–8 on all asserted grounds, finding a reasonable likelihood that claims 1 and 5 are anticipated by Prevost-2006.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We understand “filled” to have a broad plain and ordinary meaning. That is, “filled” broadly embraces the circumstances where something is fully filled or partially filled. Here, Petitioner’s declarant, Dr. Hoare, provides an opinion that is consistent with our understanding of the regular meaning of the word. Pet. 23; Ex. 1002, ¶ 142. We understand that Patent Owner’s position essentially contends that “filled” does not include “fully filled”—arguing that Prevost-2006 does not describe the extent to which the core material “filled” the shell structure, or that Petitioner does not show sufficiently that “filled” means “completely occupies.” Prelim. Resp. 8–10; Ex. 2001, ¶ 39. As an initial matter, we observe that neither Petitioner’s nor Patent Owner’s declarant directs us to information that would help us understand why an ordinarily skilled artisan would have understood “filled” to exclude the circumstance of being completely filled. Because of this, for purposes of deciding whether to institute review, we see no reason to interpret “filled” in a manner inconsistent with the term’s plain and ordinary meaning, which broadly includes the circumstance of being completely filled. Patent Owner is free to develop this issue in timely filed response to the Petition. On this record, however, we preliminarily find that Prevost-2006 meets the “completely occupies” limitation of claim 1 because its fiber is described as a shell structure that is “filled” with a core structure. Ex. 1010, 345, 349. That circumstance distinguishes Provost-2006 from the Lee reference, which unlike Provost-2006 concerned “hollow fibers” and, during examination, was overcome by an amendment that added the “completely occupies” limitation. Prelim. Resp. 9 (quoting Ex. 1004, 616) (emphasis omitted).” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“We understand “filled” to have a broad plain and ordinary meaning. That is, “filled” broadly embraces the circumstances where something is fully filled or partially filled. Here, Petitioner’s declarant, Dr. Hoare, provides an opinion that is consistent with our understanding of the regular meaning of the word. Pet. 23; Ex. 1002, ¶ 142. We understand that Patent Owner’s position essentially contends that “filled” does not include “fully filled”—arguing that Prevost-2006 does not describe the extent to which the core material “filled” the shell structure, or that Petitioner does not show sufficiently that “filled” means “completely occupies.” Prelim. Resp. 8–10; Ex. 2001, ¶ 39. As an initial matter, we observe that neither Petitioner’s nor Patent Owner’s declarant directs us to information that would help us understand why an ordinarily skilled artisan would have understood “filled” to exclude the circumstance of being completely filled. Because of this, for purposes of deciding whether to institute review, we see no reason to interpret “filled” in a manner inconsistent with the term’s plain and ordinary meaning, which broadly includes the circumstance of being completely filled. Patent Owner is free to develop this issue in timely filed response to the Petition. On this record, however, we preliminarily find that Prevost-2006 meets the “completely occupies” limitation of claim 1 because its fiber is described as a shell structure that is “filled” with a core structure. Ex. 1010, 345, 349. That circumstance distinguishes Provost-2006 from the Lee reference, which unlike Provost-2006 concerned “hollow fibers” and, during examination, was overcome by an amendment that added the “completely occupies” limitation. Prelim. Resp. 9 (quoting Ex. 1004, 616) (emphasis omitted). Claim 5 further recites that “a cell or cell culture is contained in the micro gel fiber.” As we observe above, Prevost-2006 discloses that its “hollow fibers were filled with islets [cells] suspended in agarose.” Ex. 1010, 345; Pet. 24. Thus, on this record, we also find that Prevost-2006 discloses the claimed microfiber containing “a cell or cell culture” within the micro gel fiber. Accordingly, we determine that Petitioner has established a reasonable likelihood that it “would prevail with respect to” claim 1 and claim 5 based on anticipation by Provost-2006. 35 U.S.C. § 314(a). To provide guidance to the parties and streamline the issues for trial, we discuss below the other challenges asserted in the Petition.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundInstituted
“For example, Petitioner does not identify a reason why an ordinarily skilled artisan would have combined the teachings of double-layer and single-layer fibers. We recognize that “it is not necessary that the inventions of the references be physically combinable to render obvious the invention under review.” In re Sneed, 710 F.2d 1544, 1550 (Fed. Cir. 1983). Nevertheless, to support a conclusion of obviousness when combining the teachings of multiple references, an articulated reason with some rational underpinning to combine the known elements in the fashion claimed must be provided. See KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007); see also In re Magnum Oil Tools, Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (It is the petitioner’s “burden to demonstrate both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention[s], and that the skilled artisan would have had a reasonable expectation of success in doing so.”) (citation and internal quotation omitted). Having reviewed the parties’ arguments and evidence of record, we have doubts that Petitioner provides sufficient reasons an ordinarily skilled artisan would have combined the teachings of the multiple references asserted in this challenge to achieve the claimed invention or would have reasonably believed they would have been successful in doing so. Arctic Cat Inc. v. Bombardier Recreational Prods. Inc., 876 F.3d 1350, 1360–61 (Fed. Cir. 2017) (showing of a motivation to combine references must include evidence that a skilled artisan would have reasonable expectation of success in doing so).” slip op. at 19
- Expert testimonyPetitioner expert discountedOther
“We have concerns about whether Petitioner shows sufficiently that Nelson- 603’s disclosures would have led an ordinarily skilled artisan to create an “alginate-alginate bicomponent fiber.” Petitioner’s arguments and Dr. Hoare’s opinions contain similar wording and do not explain adequately why an ordinarily skilled artisan would have created such a fiber—beyond Nelson-603’s general disclosure that “it will be apparent to those of skill in the art that variations may be applied to the compositions and methods.” Pet. 39–40; Ex. 1002, ¶¶ 162, 199, 120; Ex. 1011, 12:57–66; 33:58–66. Without additional evidence and reasoning, we assign Dr. Hoare’s testimony on this issue little weight. See Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 (August 24, 2022) (designated: February 10, 2023) (holding declaration is entitled to little weight when it contains an exact restatement of the petition’s arguments without any additional supporting evidence or reasoning). On this record, that general instruction is not sufficient to establish that Nelson-603 would have prompted an ordinarily skilled artisan to modify any fiber disclosed in the reference to achieve the claimed invention.” slip op. at 15
§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 8,785,195 - Peaklogic, Inc. v. Wave Neuroscience, Inc.Institution deniedPTAB · Mar 23, 2023 · IPR2022-01527 · APJ David Cotta · IPR · Institution
Institution was denied for claims 1, 2, 4, 5, 7, 8, 10, and 11 because the petition did not show a reasonable likelihood of success on any asserted anticipation or obviousness ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless the Petition “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.” For the reasons discussed below, 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, 2, 4, 5, 7, 8, 10, and 11 of the ’554 patent.” slip op. at 2
- Expert testimonyPetitioner expert discountedDecided for patent owner
“Importantly, however, Dr. Silvetz does not cite anything to support his opinion that stimulation at a frequency above the peak alpha frequency moves the peak frequency. Id. Nor does Dr. Silvetz explain why such stimulation moves the peak frequency. Id. Accordingly, Dr. Silvetz’s testimony is entitled to little weight. Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24 ,2022) (Decision Denying Institution) (precedential) (finding that conclusory testimony that “does not cite to any additional supporting evidence or provide any technical reasoning to support [that testimony] . . . is entitled to little weight”); see also, 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”); Upjohn Co. v. Mova Pharm. Corp., 225 F.3d 1306, 1311 (Fed. Cir. 2000) (“Lack of factual support for expert opinion going to factual determinations, however, may render the testimony of little probative value in a validity determination.”) (quoting Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985)); Carella v. Starlight Archery & Pro Line Co., 804 F.2d 135, 138 (Fed. Cir. 1986) (“Although in some circumstances unsupported oral testimony can be sufficient to provide” slip op. at 18
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentable
“a) Alleged express disclosure The evidence of record does not support Petitioner’s contention that Klimesch expressly discloses the intrinsic frequency limitation. Although Klimsech discloses treating subjects with rTMS at a frequency one Hz above the intrinsic frequency (IAF + 1 HZ), it does not disclose what effect such treatment has on the intrinsic frequency. See generally, Ex. 1005. Petitioner asserts that “stimulation at IAF + 1 Hz triggered increased EEG output in the EEG band of that stimulation frequency (IAF to IAF + 2 Hz) directly corresponding to enhanced alpha power in that EEG band.” Pet. 24. EEG power is, however, distinct from frequency. See e.g., Ex. 2002, Fig. 1A (spectral analysis plotting frequency on the x-axis and power on the y-axis). Thus, even if we were to credit Petitioner’s assertion that stimulation at IAF + 1 Hz “increased EEG output” and “enhanced alpha power,” such assertion does not support that Klimesch expressly discloses changing the frequency at which peak alpha power is observed.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“1. Claim 1 Petitioner relies on the same evidence discussed in connection with Grounds 1 and 2 to establish disclosure of the intrinsic frequency limitation. Pet. 39 (“For the reasons provided above in Grounds 1 and 2, both Klimesch and Jin disclose this element [the intrinsic frequency limitation] of claim 1. In particular, the recited movement is the natural, inherent consequence of applying a magnetic field to the human brain at or near the subject’s peak frequency in the alpha band”). We have already determined that this evidence is insufficient to support that Klimesch or Jin discloses the intrinsic frequency limitation. Accordingly, we determine that Petitioner has not established a reasonable likelihood that it will prevail in showing that the combination of Klimesch and Jin renders claim 1 obvious.” slip op. at 25
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,480,554 - Peaklogic, Inc. v. Wave Neuroscience, Inc.Institution deniedPTAB · Mar 23, 2023 · IPR2022-01550 · APJ Devon Zastrow Newman · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claim 39 was anticipated by Klimesch or Jin.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2019). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . 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). Upon consideration of the Petition, the Preliminary Response, 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 claim 39 of the ’354 patent.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Claim 39 describes a device used to treat a subject by creating an electromagnetic field to “tune” the brain and affect mood, focus, and cognition of human subjects. Ex. 1001, 62:62–63:34. Briefly, claim 39 recites a device that creates an electromagnetic field using an electromagnet. A first processor “tunes” the brain by firing the magnetic field. The first or a second processor moves one of the recited frequency characteristics in the brain to a preselected different frequency. The term “moves” in claim 39 describes a function of the first or second processor, which provides the means by which the brain frequency is shifted. See MasterMine Software, Inc. v. Microsoft Corp., 874 F.3d 1307, 1312–1315 (reviewing cases applying and distinguishing reasoning in IPXL Holdings, 430 F.3d at 1383– 84. Unlike IPXL Holdings, there is no confusion here as to when infringement of this claim would occur; infringement occurs when one makes, uses, offers to sell, or sells the claimed apparatus, which is capable of use for treatment. For this reason, we find that the recitation “wherein the first processor or a second processor moves” in claim 39 does not recite a method step, but rather describes the function of the recited structure – the first or second processor – that is capable of performing the recited (a) through (e) steps. MasterMine, 874 F.3d at 1315–16 (“the claims at issue here merely claim that the system ‘possess[es] the recited structure [which is] capable of performing the recited functions.’”) (alterations in original). As a result, we agree with Patent Owner that the recitation “wherein the first processor or a second processor moves” is limiting.7 For purposes of resolving whether to institute trial, we adopt and apply the interpretations stated in the district court’s claim construction order, Ex. 2001.” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“(1) Alleged express disclosure The evidence of record does not support that Klimesch expressly discloses the intrinsic frequency limitation. Although Klimsech discloses treating subjects with rTMS at a frequency one Hz above the intrinsic frequency (IAF + 1 HZ), it does not disclose whether the treatment moves the intrinsic frequency. See generally, Ex. 1005. Petitioner asserts that stimulation at IAF + 1 Hz “triggered increased EEG output in the EEG band of that stimulation frequency (IAF to IAF + 2 Hz) directly corresponding to enhanced alpha power in that EEG band.” Pet. 27. Enhancing EEG power is, however, distinct from moving frequency. See, e.g., Ex. 2002, Fig. 1A (spectral analysis plotting frequency on the x-axis and power on the y-axis). Thus, even if we were to credit Petitioner’s assertion that stimulation at IAF + 1 Hz “increased EEG output” and “enhanced alpha power,” such assertion does not support that Klimesch expressly discloses moving the frequency at which peak alpha power is observed. Petitioner also directs us to Klimesch’s disclosure that rTMS at IAF + 1 Hz resulted in “a significant increase in lower-2 and upper alpha desynchronization (ERD) during mental rotation.” Ex. 1005, 1132 (cited at Pet. 27–28). But ERD is also distinct from frequency. See, e.g., Ex. 2002, Fig. 1A (spectral analysis showing ERD as the difference in alpha power when subjects are performing a task as compared to when subjects are in a state of alert wakefulness). Thus, an increase in ERD does not support that Klimesch discloses changing the frequency at which peak alpha power is observed. As Petitioner does not direct us to any other disclosure in Klimesch that supports moving the intrinsic frequency, Petitioner is unlikely to prevail in establishing that Klimesch expressly discloses the intrinsic frequency limitation.12” slip op. at 18
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable
“Ex. 1001, 34:56–35:5. Although this disclosure supports that the intrinsic frequency can be shifted up or down by applying a “specific magnetic field close to the head,” it does not teach that the intrinsic frequency necessarily shifts every time a magnetic field above or below the patient’s peak alpha frequency is applied. Scaltech Inc. v. Retec/Tetra L.L.C., 178 F.3d 1378, 1384 (Fed. Cir. 1999) (“Inherency may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient to establish inherency.”). In addition, Petitioner does not direct us to disclosure in the ’354 patent supporting that stimulation at IAF + 1 Hz under the circumstances disclosed in Klimesch, will necessarily shift the intrinsic frequency. See, Ex. 1003 ¶ 20 (testimony of Dr. Silvetz identifying factors that impact how the brain responds to rTMS); Ex. 1001, 40:19–32 (describing “parameters that require optimization for rTMS,” including: “[f]requency, “[i]ntensity, “[d]uration,” and “[s]ite of stimulation”).” slip op. at 21
Claim construction§ 102 anticipationcites Phillips · GrahamPatents in suitUS 8,475,354
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.