- PTAB · Aug 30, 2023 · IPR2023-00521 · APJ Jon B Tornquist · IPR · Institution
The Board instituted IPR on claims 19–61 and 63–81 on all petitioned grounds, finding a reasonable likelihood that Doud anticipates claims 19–61 and 63–75.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2022). The standard for institution is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless the Director determines . . . 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 set forth below, we determine that Petitioner demonstrates a reasonable likelihood of prevailing with respect to at least one claim of the ’740 patent. Accordingly, we grant institution of an inter partes review.” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther
“the application describe the claim limitations exactly,” the application must demonstrate to persons of ordinary skill in the art that the applicants invented a composition including those limitations. Wertheim, 541 F.2d at 262. On its face, the range of “at least 0.01 wt. %” encompasses a range that is broader than 0.01–35 wt. %, and Patent Owner does not sufficiently explain why a person of ordinary skill in the art would understand from merely a disclosure of 35 wt.% that the inventors were in possession of the entire claimed range for copper, cobalt, or nickel in the magnesium composition.” slip op. at 11
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedOther
“On this record, the term “at least 0.01 wt. %” in the ’740 patent encompasses values for nickel, copper, and cobalt that are higher than the 35 wt. % (nickel and copper) and 20 wt. % (cobalt) limits outlined in the parent and grandparent applications. Accordingly, we determine that there is a reasonable likelihood that claim 19 of the ’740 patent is not entitled to the benefit of the filing dates of its priority applications. Challenged claims 20–61 and 63–75 depend from claim 19 and there is no argument presented that these claims have independent written description support in Doud. For example, there is no evidence presented that any of these dependent claims narrow the ranges for each of copper, nickel, and cobalt recited in in the ’295 application for these claims.7 Accordingly, for purposes of this Decision, we apply Doud as prior art to challenged claims 19–61 and 63–75.” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“as the ’740 patent. For example, Doud and the ’740 patent both disclose a method of forming a novel magnesium composite that includes melting an AZ91D magnesium alloy containing 90 wt. % magnesium, 9 wt. % aluminum, and 1 wt. % zinc. Ex. 1005 ¶¶ 45, 47; Ex. 1001, 21:43–51, 22:48–53, 33:32–43, 34:9–12. To this alloy is added either 7 wt. % nickel or 10 wt. % copper. Ex. 1005 ¶¶ 45, 47, 53, 57; Ex. 1001, 21:48–51, 22:53–56, 33:35–36, 34:12–13. These additives are mixed in the magnesium alloy at a temperature that is less than the melting point of copper or nickel, and the casting is then cooled. Ex. 1005 ¶¶ 45, 47, 53, 57; Ex. 1001, 21:51–54, 22:56–58, 33:35, 34:12-13. Doud reports that nickel and copper, when added to molten magnesium, will form Mg2Ni and CuMg2 intermetallic, galvanically-active, in situ precipitates. Ex. 1005 ¶¶ 12–13. Doud discloses that the dissolution rate of the resulting casting material is either 325 mg/cm2-hr (nickel) or 50 mg/cm2-hr (copper) in a 3% KCl solution at 90° C. Ex. 1005 ¶¶ 45, 47, 53, 57; Ex. 1001, 21:60–62, 22:61–63, 33:41–43, 34:15–17. Doud also discloses that the average particle diameter of the additives used in the invention is generally “at least about 0.1 microns” and “typically no more than about 500 microns.” Ex. 1005 ¶ 6. Petitioner explains how the identified disclosures of Doud anticipate independent claim 19. Pet. 39–40. Petitioner also identifies where the limitations of dependent claims 20–61 and 63–75 are disclosed in Doud. Id. at 41–45. Patent Owner does not address Petitioner’s anticipation arguments with respect to claims 19–61 and 63–75, apart from arguing that Doud is not prior art to these claims. Prelim. Resp. 27–39. demonstrates a reasonable likelihood that claims 19–61 and 63–75 are anticipated by Doud.” slip op. at 16
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialPatents in suitUS 10,689,740 - 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 - Painteq, LLC v. Orthocision, Inc.InstitutedPTAB · Jul 12, 2023 · IPR2023-00451 · APJ Michael A Valek · IPR · Institution
The Board instituted IPR on claims 1–23 based on all petition grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“On the current record, we determine that the Petition demonstrates “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Accordingly, we institute an inter partes review.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have had a medical or an engineering degree and would have had experience with surgical instruments and implants used for spinal joint fusion, including [sacroiliac (“SI”)] joint fusion.” Pet. 7 (citing Ex. 1002 ¶ 15). At this stage, we find Petitioner’s description of the level of ordinary skill in the art to be sufficiently supported by the record and apply it for purposes of this Decision. slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner submits that the parties have submitted joint claim construction in the Florida litigation, and asserts that “[t]he grounds set forth in this [P]etition render the challenged claims obvious under either party’s construction.” Pet. 8 (citing Ex. 1002 ¶ 34; Ex. 1017). Nevertheless, Petitioner urges that “express construction is not necessary.” Id. at 7. At this stage of the proceeding and for purposes of instituting trial, we determine that there are no terms that require express construction. See” slip op. at 8
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“We agree with Petitioner. Figures 30, 32A and 32B in the Specification depict a working channel with tangs 180a and 180b. See Ex. 1001, Figs. 30, 32A–B. These figures and all of the related description in the Specification describing a working channel with tangs appear in the Parent (Ex. 1006, Figs. 30, 32A–B, 3:17–21, 6:47–54, 15:25–51), but not in the Grandparent. See also Ex. 1002 ¶¶ 42–43 (explaining the same). Accordingly, based on the current record, we find that the Grandparent application does not provide sufficient written description for the limitations requiring that the working channel have tangs in the independent claims. See Ex. 1001, 42:7 (limitation 1.b.4 “at least one tang on a distal end”), 43:9–11 (limitation 10.b.2 “two bilateral blunt tangs on a distal end”), 44:31–32 the challenged claims are not entitled to the benefit of the Grandparent’s filing date.” slip op. at 9
Claim construction§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 11,083,511 - Tokyo Ohka Kogyo., Ltd. v. Fujifilm Electronic Materials U.S.A., Inc.All claims unpatentablePTAB · May 31, 2023 · PGR2022-00010 · APJ Jo-Anne M Kokoski · PGR · Final written decision
Claims 1–15 are unpatentable for lack of written description support under § 112(a); the Board did not reach either obviousness ground.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person having ordinary skill in the art (“POSA”) “would have had a Bachelor degree in materials science, engineering, chemistry or similar technical discipline, and had at least two years of experience relating to the design and development of semiconductor manufacturing processes.” Pet. 14. Petitioner further submits that, “[a]lternatively, such a person may have had additional graduate education as a substitute for professional experience, or significant work experience as a substitute for formal education.” Id. Patent Owner states that, “[w]ithout taking a position on the correctness of this definition, Patent Owner applies Petitioner’s POSA definition.” PO Resp. 11 (citing Pet. 14). 3 The Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112–29, 125 Stat. 284 (2011), revised 35 U.S.C. § 103 effective March 16, 2013. Petitioner contends, and Patent Owner does not contest, that “the earliest priority date claimed by the ’329 patent” is December 6, 2013. Pet. 13; PO Resp. 6. Because the undisputed earliest claimed priority date of the ’329 patent is after March 16, 2013, we apply the AIA versions of §§ 102 and 103. record, and is consistent with the level of skill in the art at the time of the invention as reflected in the prior art in this proceeding.” slip op. at 5
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“We disagree. It is clear from the plain language of claim 1 that the claimed “cleaning composition” is a composition for cleaning that includes four named components and has a specified pH. Ex. 1001, 29:2–9. The ’329 patent specification unambiguously teaches that the cleaning composition is for removing residues from semiconductor substrates. Id. at 1:23–29, 2:10–12, 2:17–33, 15:52–55. Although the ’329 patent describes a cleaning composition that comprises a redox agent, a chelating agent, a metal corrosion inhibitor, an organic solvent, and water, we see no reason to construe the term “cleaning composition” itself to require these components. Claim 1 expressly recites expressly including or precluding a chelating agent or a metal corrosion inhibitor. Ex. 1001, 29:2–9. The Federal Circuit advises that the specification “is not a suitable substitute for, nor can it be used to rewrite, the chosen claim language. ‘Specifications teach. Claims claim.’” SuperGuide, 358 F.3d at 875 (quoting SRI Int’l v. Matsushita Elec. Corp. of Am., 775 F.2d 1107, 1121 n. 14 (Fed. Cir. 1985) (en banc)). The ’329 patent specification does teach a cleaning composition that includes a redox agent, a chelating agent, a metal corrosion inhibitor, an organic solvent, and water, but claim 1 is directed to a cleaning composition that expressly requires only a subset of those components. Patent Owner’s proposed construction would effectively rewrite the claim by adding unclaimed components, which we decline to do under the guise of claim construction. See id. (“Though understanding the claim language may be aided by the explanations contained in the written description, it is important not to import into a claim limitations that are not a part of the claim.”).” slip op. at 9
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“that Petitioner establishes that the ’329 patent does not provide sufficient written description support for the challenged claims. Pet. 15–43; Ex. 1007 ¶¶ 56–82. More specifically, we find that the ’329 patent does not reasonably convey to a POSA that the inventor was in possession of cleaning compositions that do not include a chelating agent or a metal corrosion inhibitor. There is no dispute, on this record, that the ’329 patent specification explicitly teaches that a redox agent, a chelating agent, a metal corrosion inhibitor, an organic solvent, and water are mandatory components of the cleaning composition described therein. PO Resp. 15 (Patent Owner agreeing with Petitioner that “[t]he ’329 patent’s disclosure is unambiguously explicit regarding mandatory components of the cleaning compositions described therein.” (citing Pet. 17; Ex. 1007 ¶¶ 56–57) (emphasis omitted, alteration in original)); see Ex. 1001, 3:47–48, 3:62–64, 10:24–26, 10:66–11:2, 12:3–4; Ex. 1007 ¶¶ 56–67. Claim 1, however, does not require that the cleaning composition include a chelating agent or a metal corrosion inhibitor. Ex. 1001, 29:2–9. Therefore, establishing proper written description support for claim 1 requires more than showing that the inventor was in possession of a cleaning composition that includes a redox agent, a chelating agent, a metal corrosion inhibitor, an organic solvent, and water; the ’329 patent must also show that the inventor was in possession of a cleaning composition that includes only a redox agent (hydroxylamine), an organic solvent (an alkylene glycol), water, and an alkanolamine. Id.” slip op. at 13
Patent outcomesUS 10,927,329 unpatentableClaim construction§ 112 disclosurecites PhillipsPatents in suitUS 10,927,329 - Home Depot U.S.A., Inc. v. Lynk Labs, Inc.All claims unpatentablePTAB · May 22, 2023 · PGR2022-00009 · APJ Monica S Ullagaddi · PGR · Final written decision
Claims 1–5, 7–12, and 14–19 are unpatentable based on lack of written description, anticipation by Bruning, or obviousness over Bruning and Kabel.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“lighting device.” Accordingly, we determine that the level of ordinary skill in the art is “a bachelor’s degree in electrical engineering, or similar technical field, with two years of relevant experience in the field of design and/or development of LEDs and circuits,” as Petitioner proposes and that “the field of design and/or development” would be “in the context of lighting devices” as Patent Owner proposes, in which “[a]n increase in experience could compensate for less education.” Id.; Pet. 24 (citing Ex. 1002 ¶ 46).” slip op. at 15
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalDisclaimer foundDecided for patent owner
“theoretically fall under the “or greater” portion of the amended claim limitation “forward voltage of 6V or greater,” Applicant distinguished Colby on the basis that the 120V AC voltage from a wall outlet is not “the minimum voltage difference required between the anode and cathode of the LEDs in the claimed circuit to allow current to flow through the LEDs.” See Ex. 1023, 9 (emphasis added). Applicant’s argument specifically identifies the claim language at issue––“forward voltage of 6V or greater”––and specifically states that it is not disclosed because Colby does not disclose the minimum voltage and instead, discloses something else, something larger–– 120V AC voltage. Accordingly, we conclude that Applicant disclaimed any voltage that is more than “the minimum voltage difference required between the anode and cathode of the LEDs in the claimed circuit to allow current to flow through the LEDs” from the scope of “forward voltage.”” slip op. at 25
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“4. 35 U.S.C. § 112(a) With respect to the written description requirement, we are persuaded” slip op. at 32
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable
“Basis § Unpatentable Unpatentable Lack of written description, 3, 10, 17 112(a) 3, 10, 17 Lack of enablement 3, 10, 17 112(b) Indefiniteness 3, 10, 17 Lack of written description, 4, 11, 18 112(a) 4, 11, 18 Lack of enablement 4, 11, 18 112(b) indefiniteness 4, 11, 18” slip op. at 77
Patent outcomesUS 10,932,341 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · Graham · NautilusPatents in suitUS 10,932,341 - 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 - Sandoz Inc. v. Boehringer Ingelheim International GmbHInstitution deniedPTAB · Nov 7, 2022 · PGR2022-00037 · APJ Devon Zastrow Newman · PGR · Institution
The Board denied institution because Petitioner did not show that the patent was eligible for post-grant review; the challenged claims were entitled to the pre-AIA priority date.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Accordingly, we find that Petitioner has not identified any challenged claim that has an effective filing date on or after March 16, 2013. For this reason, we find that Petitioner has not shown sufficiently that the ’265 patent is eligible for post-grant review. IV. CONCLUSION After considering the evidence and arguments presently before us, we determine Petitioner has not shown that the ’265 patent is eligible for post-grant review. Accordingly, we do not institute a post-grant review. V. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 324(d), the Petition is denied.” slip op. at 29
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner
“To interpret “stable,” we begin with how the term is used in independent claims 7 and 19. Both terms recite “stable” in relation to the pharmaceutical formulation as a whole by reciting “wherein the formulation is stable.” Ex. 1001, 189:62–190:27. From this, we conclude that the ordinary artisan, as defined above to have a relevant advanced degree and at least two years of experience in development or manufacture of therapeutic protein formulations, would have understood that the components of a “stable” formulation would maintain their integrity and desired function following preparation, including when stored as described. This meaning is supported by the following language in the specification pertaining to the disclosed pharmaceutical compositions: Pharmaceutical compositions according to the present invention are described in further details hereinbelow. In one aspect, the pharmaceutical compositions disclosed herein are physico-chemically stable and maintain the integrity of an antibody comprised in said pharmaceutical composition, for example when stored for 8 weeks at 40° C. as shown hereinbelow. Ex. 1001, 84:20–26. We also note, as Petitioner argued, that the prosecution history supports that the formulation components needed to remain functional during storage, and that Patent Owner cited to formulation integrity after a storage period of 8 weeks at 40° C as evidence of such integrity. Ex. 1004, 7380. As disclosed in the ’265 patent, Examples 9 and 12 measure function and identity of the components following storage to confirm formulation stability.” slip op. at 11
- Disclosure Requirements (§112) › Written description (Ariad)Not shown unpatentable
“burden of showing that claim 7 or 14 lacks written description support in the priority application, which Petitioner has conceded provides the same support as the ’265 patent specification. In this regard, we agree that the reasoning in Fresenius likewise applies: there is no legal requirement that a patent specification must include test results or working examples demonstrating stability for every possible composition that is covered by the claims. Fresenius at 13, citing Ariad Pharms., 598 F.3d at 1352 (stating that “the written description requirement does not demand either examples or an actual reduction to practice”). Formulations 2 and 3, disclosed in the ’265 patent specification, which Petitioner acknowledges falls within the scope of claims 7 and 14 (Pet. 26–27 (citing Ex. 1002 ¶¶ 134, 135)), were shown to be stable for 8 weeks in a syringe. Moreover, the ordinary artisan was provided with guidance in making such formulations from the teachings of the specification and has additional knowledge from the art. See Ex. 1001, 85:32–94:35. Claims 7 and 14 identify specific structures (risankizumab) and required excipients within a defined pH range, which are stable as confirmed by testing results presented in the specification. Prelim. Resp. 33; Ex. 1001, 94:14–36. On this record, we conclude that the evidence presented does not establish that it is more likely than not that an ordinarily skilled artisan would not have reasonably believed that the inventors of the ’265 patent possessed the claimed subject matter, each limitation of which is demonstrated as supported in the specification. As we have interpreted the claim term “wherein the formulation is stable” to mean “wherein the formulation maintains the functional integrity of the antibody and other components, for example when stored for 8 weeks at 40° C,” the specification supports maintenance of functional integrity as shown by the stability of Formulations 2 and 3, including when stored for a period of time. For this reason, we find that Petitioner has not shown that the ordinary artisan would not have understood the inventors of the ’265 patent possessed the subject matter of claims 7 and 14 as of the filing date of the priority application.” slip op. at 23
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not shown unpatentable
“We acknowledge that in the Fresenius case, the extensive testing disclosed in that specification supported the ordinary artisan’s ability to formulate stable compounds using such guidance, and that the specification here discloses less testing. See, e.g., Sur-Reply. 8–9. Nevertheless, it is Petitioner’s burden on this issue, and we are not persuaded that the concerns raised by Dr. Klibanov provide sufficient evidence of actual instability to justify institution on this record. See, e.g., Atlas Powder Co. v. E.I. du Pont De Nemours & Co., 750 F.2d 1569, 1577 (Fed. Cir. 1984) (finding lack of evidence that district court erred in upholding claims as enabled where defendant did not identify inoperable embodiments despite extensive testing). In particular, we are persuaded that, on this record, Petitioner’s lack of evidence of instability of any formulation falling within the limitations of claim 14 indicates that Petitioner has not established sufficiently, for purposes of trial institution, that it is more likely than not that an ordinarily skilled artisan would not have been able to practice the full scope of claim 14 invention based on the teachings of the specification.” slip op. at 28
Claim construction§ 112 disclosurecites PhillipsPatents in suitUS 11,078,265 - Askeladden LLC v. Leigh M. RothschildAll claims unpatentablePTAB · Nov 19, 2020 · IPR2019-00855 · APJ Mitchell G Weatherly · IPR · Final written decision
The Board canceled original claims 1, 2, 11, 14–19, and 21 and denied the motion to amend because the proposed substitute claims were obvious over Karthik, Robinson, and Ortiz.
RulingsFinal written decision- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner
“The claim language itself implies that the financial services provider decides which biometric information is required during the enrollment stage because the Decision Limitation is added to element 17A, which is the first step in the enrollment stage recited in elements 17A–D. However, “in assessing definiteness, claims are to be read in light of the patent’s specification and prosecution history.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 908 (2014). Patent Owner identifies support for the Decision Limitation in the Specification that favors interpreting the Decision Limitation as occurring during the transaction stage (i.e., during elements 17E–G). Mot. 14–15 (citing Ex. 1001, 9:9–14). The cited portion of the Specification states: “In another embodiment, the financial service provider may have the system set up such that the server 114 queries through the point-of-sale terminal 102 and informs the merchant which biometric identification data is/are required for the desired transaction.” Ex. 1001, 9:9–14 (emphasis added). The plain language of the claim is consistent with our interpretation because it specifies that the biometric data is the data “required for the transaction,” which refers to the “transaction” recited in element 17G (describing the operation of the claimed system during a transaction stage). Based on our review of the Specification and claim language, we conclude that the Decision Limitation is sufficiently definite under 35 U.S.C. § 112, ¶ 2. Based on that review, we also interpret the Decision Limitation to require that the financial services provider informs, through the server, which type(s) of user biometric identification data must be received at the terminal (e.g., a point-of-sale terminal) to validate the transaction. E. WHETHER THE MOTION MEETS THE REQUIREMENTS OF 35 U.S.C. § 316(d) AND 37 C.F.R. § 42.121” slip op. at 14
- Disclosure Requirements (§112) › Definiteness (Nautilus)DefiniteDecided for patent owner
“The claim language itself implies that the financial services provider decides which biometric information is required during the enrollment stage because the Decision Limitation is added to element 17A, which is the first step in the enrollment stage recited in elements 17A–D. However, “in assessing definiteness, claims are to be read in light of the patent’s specification and prosecution history.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 908 (2014). Patent Owner identifies support for the Decision Limitation in the Specification that favors interpreting the Decision Limitation as occurring during the transaction stage (i.e., during elements 17E–G). Mot. 14–15 (citing Ex. 1001, 9:9–14). The cited portion of the Specification states: “In another embodiment, the financial service provider may have the system set up such that the server 114 queries through the point-of-sale terminal 102 and informs the merchant which biometric identification data is/are required for the desired transaction.” Ex. 1001, 9:9–14 (emphasis added). The plain language of the claim is consistent with our interpretation because it specifies that the biometric data is the data “required for the transaction,” which refers to the “transaction” recited in element 17G (describing the operation of the claimed system during a transaction stage). Based on our review of the Specification and claim language, we conclude that the Decision Limitation is sufficiently definite under 35 U.S.C. § 112, ¶ 2. Based on that review, we also interpret the Decision Limitation to require that the financial services provider informs, through the server, which type(s) of user biometric identification data must be received at the terminal (e.g., a point-of-sale terminal) to validate the transaction. E. WHETHER THE MOTION MEETS THE REQUIREMENTS OF 35 U.S.C. § 316(d) AND 37 C.F.R. § 42.121” slip op. at 14
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied
“Petitioner argues that if Patent Owner were to argue that the Decision Limitation can be met by the financial services provider deciding which biometric information is required for a transaction during the enrollment or transaction stages, then the claims would be unpatentable for lack of written description support in the Specification. Opp. 8. Petitioner concedes that the portion of the Specification relied upon by Patent Owner for support describes making the decision about what biometric information is needed during the transaction stage. Id. at 9. As explained in Part II.D above, we have narrowly interpreted the Decision Limitation to encompass only such decisions. Accordingly, Petitioner does not persuade us that the Specification fails to provide the required written description for the 7 Normally, a Patent Owner must identify material in the originally filed application leading to issuance of the patent at issue that supports the proposed amendment. Lectrosonics, Paper 15 at 7. Failing to cite the original disclosure is a basis for denying a motion to amend. Id. However, because Patent Owner appears pro se, we reviewed the original disclosure ourselves to verify that the portion of the Specification cited is identically found in that disclosure. Compare Ex. 1016 ¶ 42, with Ex. 1001, 9:9–14. Accordingly, in this case, we find that Patent Owner’s citation to the Specification functionally refers to material in the original disclosure. Decision Limitation as we have interpreted it. Additionally, we conclude that Patent Owner has established that the Specification meets the written description requirement for the Decision Limitation. F. PROPOSED SUBSTITUTE CLAIMS 1, 2, 11, 14–19, AND 21:” slip op. at 17
- ScopeDecided for patent owner
“3. Whether the Amendments Enlarge the Scope of the Claims An amendment may not enlarge the scope of the claims of the patent. 35 U.S.C. § 316(d)(3); 37 C.F.R. § 42.121(a)(2)(ii). We determine that Patent Owner’s addition of the Decision Limitation narrows the scope of every challenged claim and thus satisfies the prohibition against enlarging the scope of any claim.” slip op. at 16
Patent outcomesUS 8,799,088 unpatentableClaim construction§ 103 obviousness§ 112 disclosurecites Graham · NautilusPatents in suitUS 8,799,088 - Edmit Industries, Inc. v. Smartdoor Holdings, Inc.All claims unpatentablePTAB · Mar 29, 2016 · IPR2015-00013 · APJ James A Worth · IPR · Final written decision
Claims 16–17 are unpatentable over Shea and Burke; claim 18 over Shea, Burke, and O’Brien; and claim 27 over Shea, Burke, and Leivenzon. The motion to amend is denied.
RulingsFinal written decision- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“Patent Owner disagrees for three reasons. First, Patent Owner implies that Burke is not analogous art because Burke does not disclose a door. See PO Resp. 6. Art is analogous when it is: (1) from the same field of endeavor as the claimed invention; or (2) reasonably pertinent to the particular problem faced by the inventor, if the art is not from the same field of endeavor. See In re Bigio, 381 F.3d 1320, 1325–26 (Fed. Cir. 2004). In this case, as observed by Petitioner’s Declarant, Burke expressly describes an application “as in cases where an electrical braking action is required.” Ex. 1004 ¶ 25 (quoting Ex. 1003, 1:18–22). Thus, even under Patent Owner’s argument that Burke is not specific to the field of doors, we agree with Petitioner’s Declarant that Burke is relevant to the problem of braking in electrified devices. Burke discloses an approach to that problem by absorbing energy from a motor, operated as a generator, for the purpose of braking. Ex. 1003, 1:16–25, 3:11–12.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“brake shoes based on the application of centrifugal force. Ex. 1009, 5:59– 63. Petitioner’s assertion is that a person of ordinary skill would have found it obvious to use a different braking mechanism as a substitute for a governor to achieve the same function. In particular, Petitioner proposes substitution of the frictional braking mechanism of Shea (i.e., a braking mechanism that is purely mechanical), with the dissipative braking mechanism of Burke (i.e., a braking mechanism that also converts mechanical energy to electrical energy). In this case, the fire door of Shea, with the motor/generator of Burke substituted for the motor/governor of Shea, would operate to blunt or slow the movement of the door on descent while allowing the door to close. See Ex. 1004 (Haas Decl.) ¶ 26. We determine that the asserted combination of Shea and Burke would operate in the same manner as the fire door of Shea—to slow the movement of the door, while allowing the door to close under the force of gravity. Id. ¶ 24. We agree with Petitioner’s Declarant that this would have been an obvious substitution as the use of a known technique to improve functionality. See id. ¶ 26. Petitioner’s proposed combination is thus the substitution of an electrical component for an analog component, which does not destroy the principle of operation because it does not destroy the overall principle of operation of the device. See Mouttet, 686 F.3d at 1332. We conclude that this type of fitting together of teachings would have been obvious to a person of ordinary skill in the art. KSR, 550 U.S. at 420 (“a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle”). Viewing the evidence as a whole, we conclude that a person of ordinary skill in the art would have applied the teachings of Burke regarding regenerative braking to the fire door of Shea in order to improve operation of the door and to make use of excess energy from rotation. We are further persuaded by Petitioner’s arguments that Burke teaches that the braking can have the additional advantage of powering another device and that a person of ordinary skill would have sought a substitution of components in order to achieve the advantages of Burke’s motor/generator. See Pet. Reply 11–12 (quoting Randall Mfg., 733 F.3d at 1363 (“doing so would allow the designer to achieve the other advantages of the Aquino assembly while using a stowage strategy that was very familiar in the industry”)).” slip op. at 15
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied
“However, the additional limitations would not avoid unpatentability because Burke and O’Brien both use a motor/generator system, O’Brien’s motor/generator uses DC power (Ex. 1008, 5:15), Burke and O’Brien both use regenerative braking, and Burke recites the charging of a storage battery by the motor/generator which is capable of braking (Ex. 1003, 3:4–16). Therefore, the asserted combination of Shea, Burke, and O’Brien already contains the features recited as additional limitations in proposed substitute claim 40 (and the similar recitations in proposed substitute claims 41 and 42). We have already concluded supra, that the combination of Shea, Burke, and O’Brien would have been obvious to a person of ordinary skill in the art. Patent Owner does not explain why the additional recitations of its proposed substitute claims would have been nonobvious over this combination. Mot. Amend 4–14. Patent Owner argues that the combination of Shea and Burke would not make use of a DC battery by itself to open or close a door. Id. at 11–12. However, nothing in the additional limitations of proposed substitute claims 40–42 requires that a DC battery provide power to open or close a door without an additional power supply (as discussed above with respect to claim 16). More importantly, the combination of Shea, Burke, and O’Brien would make use of the DC-powered components—the DC motor/generator of O’Brien. Ex. 1008, 5:4–15. Burke discloses using the motor/generator to charge a battery with the regenerated energy. Ex. 1003, 3:12–13. Therefore, the combination of Shea, Burke, and O’Brien already contains the elements of the additional limitations. We conclude that Patent Owner has not met its burden of proving that the additional recitations of proposed substitute claims 40–42 would have been nonobvious over this combination. See Paper 15, 4–16.9” slip op. at 23
- Disclosure Requirements (§112) › Definiteness (Nautilus)DefiniteDecided for patent owner
“As to Petitioner’s argument that proposed substitute claim 43 is indefinite, we determine that the term “substantially uniform speed” is reasonably clear to a person of ordinary skill when read in context of the entire claim limitation and disclosure, which requires the application of “more and more braking” to compensate for the dynamics of the door during closing, e.g., to offset the potential for acceleration due to gravity. Ex. 1001, 12, 19–29; see In re Packard, 751 F.3d 1307, 1311 (Fed. Cir. 2014).” slip op. at 25
Patent outcomesUS 6,484,784 unpatentable§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 6,484,784
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.