- Life Spine, Inc. v. Globus Medical, Inc.All claims unpatentablePTAB · Jun 11, 2024 · IPR2022-01602 · APJ Devon Zastrow Newman · IPR · Final written decision
Claims 1–14 are unpatentable: claims 1–3 and 8–10 are anticipated by Weiman, and claims 4–7 and 11–14 are obvious over Weiman and Mozeleski; the revised motion to amend is denied.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 11 (citing Ex. 1002 (Drewry Decl.) ¶¶ 76–79). Patent Owner does not dispute Petitioner’s proposal. See generally Response. We adopt Petitioner’s proposed level of ordinary skill in the art because it is consistent with the cited prior art and is undisputed on this record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (indicating that the prior art itself may reflect an appropriate skill level).” slip op. at 11
- Expert testimonyPetitioner expert creditedDecided for petitioner
“We find persuasive, and credit, Mr. Drewry’s testimony that (1) a POSITA would have appreciated that the proposed modification to replace Weiman’s screw/socket with Waugh’s angled version provides benefits including “avoiding selected muscular and abdominal anatomical structures,” and (2) such “benefits would have been desirable for certain applications, such as those where the patient’s anatomy dictates that OLIF would provide the patient with the best medical outcome.” Ex. 1044 (Drewry Second Supp. Decl.) ¶¶ 23–26; see also Ex. 1043 (Waugh), ¶¶ 54, 87–90 (describing use of angled screw holes to, e.g., “receive a fastener via a surgical pathway” and configured “to penetrate endplate tissue of a vertebral body”). We find the weight of evidence supports Petitioner’s articulation of a POSITA’s understanding of how to use angles to avoid anatomical features” slip op. at 61
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner asserts that no terms require construction “because they are shown to be anticipated and/or obvious regardless of construction.” Pet. 12. Patent Owner did not propose any terms for construction. See generally Response. We determine that no claim terms require express construction to render this Decision.” slip op. at 18
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“j. Conclusion on Claim 1 For the above reasons, we determine that Petitioner has shown by a preponderance of the evidence that Weiman discloses each and every limitation of claim 1, and therefore anticipates claim 1.” slip op. at 28
Patent outcomesUS 9,956,087 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 9,956,087 - PTAB · Oct 31, 2023 · PGR2022-00040 · APJ Cynthia M Hardman · PGR · Final written decision
The Board cancelled claims 1–17 and denied substitute claims 18–30 for lack of written-description support; it did not reach the remaining grounds against the substitute claims.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“For the reasons discussed below, on the full trial record, we find that Patent Owner has not carried its burden of showing by a preponderance of the evidence that the proposed substitute claims introduce no new matter relative to the original disclosure. 35 U.S.C. § 326(d)(3); 37 C.F.R. § 42.221(d)(1); see also Paper 58, 2 (Patent Owner acknowledging that it “bears the burden to meet the regulatory and statutory requirements” for a motion to amend, including demonstrating that the substitute claims do not “introduce new matter”). Importantly, we note that Patent Owner fails to explain how the material cited in the claim chart supports the claims. See Mot. 15–16. Instead, Patent Owner provides only a claim chart with bare citations, leaving it to the panel to discern how the cited material supports the claim limitations. See id. Patent Owner’s failure to explain the citations constitutes a fatal error, as we have reviewed the passages cited by Patent Owner and are unable to discern where support is found for several of the substitute claim limitations. Where, as here, “the Board is unable to determine how the specification and drawings support the proposed substitute claims, the motion to amend may be denied.” Patent Trial and Appeal Board Consolidated Trial Practice Guide (Nov. 2019) (“TPG”),6 71.” slip op. at 15
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“Petitioner persuades us that the ’418 Application lacks adequate written description support for the formulation limitations of proposed substitute claim 18 [limitations 18a–8c]. As outlined by Petitioner and its declarants, the ’418 Application, including the Abstract, Field of the Invention, Summary of the Invention, and Detailed Description of the Invention sections, uniformly focuses on phosphate prodrugs of levodopa and carbidopa. See, e.g., Ex. 1004 (Sloan Decl.) ¶¶ 38–55, 64–69; Ex. 1003 (LeWitt Decl.) ¶¶ 89–97; Ex. 1047 (Forrest Decl.) ¶¶ 40–74, 80–92; Opp. 6– 10; Pet. 23–26, 49–55. We agree with Petitioner that “nothing in the specification suggests that the invention includes methods of subcutaneous infusion with anything other than the carbidopa prodrugs and L-dopa prodrugs of Formulas (I) and (II), respectively, or teaches how to get sufficient amounts of either L-dopa or carbidopa into solution, or achieve particular L-dopa plasma levels, without those particular prodrugs.” Pet. 27. Petitioner persuades us that the ’418 Application fails to contain “[so] much as a single generic sentence, anywhere in the application, suggesting the inventors possessed the claimed formulations.” Sur-reply 3. Additionally, the ’418 Application contains no example teaching administration of an aqueous formulation comprising carbidopa itself with levodopa itself or one of the three claimed levodopa prodrugs, let alone one that is suitable for continuous subcutaneous administration. See Ex. 1047 (Forrest Decl.) ¶¶ 61–72, 82–92. Patent Owner is correct that to establish written description support, neither “an actual reduction to practice,” nor a verbatim recitation of the claims is required. Sur-reply 4. Nevertheless, “[a]lthough examples are not always required to satisfy the written description requirement, the lack of any disclosure of examples may be considered when determining whether the claimed invention is adequately described.” Bos. Sci. Corp. v. Johnson & Johnson, 647 F.3d 1353, 1364 (Fed. Cir. 2011). Here, the lack of an actual reduction to practice or verbatim description of a formulation that falls within the scope of the claims is relevant, because we also see no other description or material in the ’418 Application that suggests the claimed methods extend to continuous subcutaneous administration of a composition comprising levodopa or one of the three claimed levodopa prodrugs, together with carbidopa, in an aqueous carrier.” slip op. at 28
- ExcludeMotion to exclude, deniedDenied
“All of the exhibits that are the subject of Patent Owner’s motion to exclude relate to the prior-art status and/or authenticity of Yacoby-Zeevi and ancillary related documents underlying Petitioner’s prior art-based challenges to the proposed substitute claims. See generally MTE. Because we deny Patent Owner’s request to enter proposed substitute claims 18–30 based on lack of written description support and do not reach Petitioner’s prior-art based challenges to the patentability of these claims, we do not rely on Exhibits 1005, 1007, 1040–1044, 1046, or 1048–1050 in this Decision. Accordingly we dismiss Patent Owner’s Motion to Exclude as moot.” slip op. at 49
- Strike new argumentNew argument consideredDenied
“On the other hand, Petitioner shows that Patent Owner took positions in its Motion to Amend that it only later sought to support with technical declarations. For example, in the Motion to Amend, Patent Owner elected to assert “that levodopa and carbidopa could be ‘interchanged’ in a formulation with their prodrugs, and that a skilled artisan could ‘perform a pharmacokinetic analysis to predict steady state levodopa plasma levels’ using the ‘parent compounds’ based on Example 24.” MTS 2 (citing Mot. 12–13). Patent Owner, however, “chose to forgo any expert support” on these issues at the time it filed its Motion to Amend, and instead waited until the Reply to submit technical declarations in support of these arguments. Id. We agree with Petitioner that although Patent Owner “was not required to anticipate the arguments that [Petitioner] would make in its Opposition” to the Motion to Amend, if Patent Owner “wanted to provide expert testimony to support the positions it actually took” in that Motion, “the TPG required [Patent Owner] to do so at that time, instead of waiting until [Petitioner] had limited ability to respond.” Id. at 5. Accordingly, we agree with Petitioner that in this respect at least some portions of Patent Owner’s Declarations are untimely, because it is “improper for a reply to present new evidence (including new expert testimony) that could have been presented in a prior filing.” TPG 74. Nevertheless, an order striking arguments and evidence in their entirety is an “exceptional remedy,” particularly under the circumstances here, where some portions of the Declarations are proper, while other portions are untimely. TPG 80. Moreover, “there is a strong public policy for making all information filed in an administrative proceeding available to the public.” Liberty Mut. Ins. Co. v. Progressive Cas. Ins. Co., CBM2012- 00010, Paper 59 at 40 (PTAB Feb. 24, 2014). Under the facts of this case, Patent Owner was permitted to file evidence to respond to Petitioner’s unpatentability claims, but also belatedly supported positions it made in earlier attorney argument. Petitioner’s Motion to Strike, however, challenges all of Patent Owner’s evidence, without acknowledging that some portions constitute proper reply. Although “[t]he Board is not required to attempt to sort proper from improper portions of the reply” (TPG 74, emphasis added), under the circumstances here, we agree with Patent Owner that Petitioner’s lack of specificity as to what it seeks to strike is fatal to Petitioner’s motion. Accordingly, we decline to strike the Declarations in their entirety as untimely.” slip op. at 46
§ 112 disclosurePatents in suitUS 11,091,507 - Arkema Inc. / Arkema France v. Honeywell International Inc.All claims unpatentablePTAB · Aug 25, 2022 · PGR2016-00012 · APJ Sheldon M Mcgee · PGR · Remand
Claims 1–20 are unpatentable under § 102(a) for prior public use; the Board did not reach the remaining anticipation, obviousness, and enablement grounds.
RulingsRemand decision- RemandOther
“On October 1, 2019, the Federal Circuit held that we “abused [our] discretion by assuming the authority that 35 U.S.C. § 255 expressly delegates to the Director: to determine when a Certificate of Correction is appropriate,” and vacated our Final Written Decision. Honeywell Int’l Inc. v. Arkema Inc., 939 F.3d 1345 (Fed. Cir. 2019). The Federal Circuit instructed us to “authorize Honeywell to file a motion seeking leave to petition the Director for a Certificate of Correction.” Id. at 1351. Pursuant to the Federal Circuit’s mandate, we gave our authorization, and Patent Owner filed its Motion for Leave to Request a Certificate of Correction. PGR11 Paper 61; PGR12 Paper 41. After additional briefing from the parties was complete, we granted Patent Owner’s Motion. PGR11 Paper 77; PGR12 Paper 57. Patent Owner filed its Request for a Certificate of Correction, as well as a Petition to Accept [Unintentionally] Delayed Claim to Priority under 35 U.S.C. § 120 and 37 C.F.R. § 1.78. PGR11 Ex. 2174; PGR12 Ex. 2172.” slip op. at 3
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“Synthes USA, LLC v. Spinal Kinetics, Inc., 734 F.3d 1332, 1344 (Fed. Cir. 2013). And, although there are no bright-line rules for the amount of disclosure needed in an unpredictable art, that amount “necessarily changes with each invention” and “changes with progress in the field.” Ariad, 598 F.3d at 1351. Here, we find that the art of AAC was unpredictable and that a heat-transfer composition for AAC required specific technical features that were unpredictable and unexpected. Thus, we conclude that the ’525 application requires a more-detailed disclosure than would be required in a predictable field to adequately demonstrate possession of a heat-transfer composition consisting essentially of HFO-1234yf and PAG for use in AAC. (iii) Disclosure in the ’525 Application With these background findings in mind, we now turn to the four corners of the ’525 application—and we find that the ’525 application does not contain the detailed disclosure needed in this case to reasonably convey possession of a heat-transfer composition consisting essentially of HFO- 1234yf and PAG for use in AAC.” slip op. at 37
- Skill levelSkill level board ownDecided for patent owner
“develops new refrigerants for use as heat transfer fluids. Ex. 1002 ¶ 149. Such a person would have had a Ph.D. in Chemistry, Chemical Engineering, Mechanical Engineering, Material Science, or a related field or discipline and at least 3 to 5 years of experience, or alternatively an M.S. degree and 5 to 10 years of experience. Id. Patent Owner’s Declarant, Dr. Bivens, provides a similar description of the person of ordinary skill in the art, stating that such a person would have a B.S. degree in Chemical Engineering or Chemistry, and five years of work experience, or a Ph.D. or M.S. degree and 2–3 years of experience. Ex. 2001 ¶ 23. Based on these descriptions, we find that the parties’ definitions of ordinary skill in the art are substantially the same, and agree with the parties that an ordinarily skilled artisan would be educated in the Chemical and Chemical Engineering arts or related disciplines. We also agree with the parties that a person having less formal education, such as a B.S. or M.S. degree, would require more years of experience than a person with more formal education, such as a Ph.D., to qualify as an ordinarily skilled artisan. We also find that neither party states how any difference in the parties’ articulated levels of skill impacts this proceeding. Thus, our analysis would be the same regardless of any minor differences between the parties’ respective articulations. Finally, we note that the level of ordinary skill in the art is reflected by the prior art of record. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 20
- Novelty / Anticipation (§102) › Prior-art status of a reference › On-sale bar (Pfaff, Helsinn)UnpatentableUnpatentable
“Tr. 114:15–115:18 (emphases added). Thus, we find that Patent Owner does not contest that a heat-transfer composition consisting essentially of HFO- 1234yf and PAG for AAC was in public commercial use before the March 26, 2014, filing date of the ’017 patent. Accordingly, we find that Petitioner’s evidence, together with Patent Owner’s concessions, demonstrates by a preponderance of evidence that the claimed subject matter of the ’017 patent was in commercial use before its March 26, 2014, effective filing date. See Ex. 1002 ¶¶ 399–409. In particular, as to claims 1, 3–10, 12, 13, and 15–20, we credit Dr. Brown’s uncontested testimony that the refrigerant-lubricant AAC composition of the Ford Transit Custom Bus, the Mazda CX 5 (2.0i and 2.2D), and the Opel Mocca used HFO-1234yf and a PAG lubricant as early as 2012. Ex. 1002 ¶ 399 (citing Ex. 101324, 2, 38, 55, 70). We also credit Dr. Brown’s 24 Behr Hella Services, Refrigerant and Oil Filling Quantities Passenger Cars & Commercial Vehicles 2014–15. PGR12 Ex. 1013. (“Service Guide”). PGR12 Ex. 1013. The Service Guide provides tables setting forth specifications for refrigerant type, refrigerant quantity, vehicle manufacturers’ original equipment compressor oil type, and oil filling quantity for the air-conditioning system of each vehicle listed in the tables. Id. at 2–3. Petitioner and Dr. Brown direct us to the Sevice Guide’s entries calculations, which show that the Ford Transit Custom Bus had an AAC refrigerant-lubricant composition of 26.7% of PAG lubricant and 73.3% of HFO-1234yf (Ex. 1002 ¶ 401 (citing Ex. 1013, 38)); the Mazda CX 5 2.0i had 16.7% PAG lubricant and 83.3% HFO-1234yf (Ex. 1002 ¶ 402 (citing Ex. 1013, 55)); the Mazda CX 5 2.2D had a 17.5% PAG lubricant and 82.5% HFO-1234yf (id.); and the Opal Mocca had 11.6% PAG lubricant and 88.4% HFO-1234yf (Ex. 1002 ¶ 402 (citing Ex. 1013, 70)). As to dependent claims 2, 11, and 14, which all require that the lubricant is present “in an amount from about 30% to about 50% weight,” we credit Dr. Brown’s uncontested testimony that the refrigerant-lubricant composition of the Ford Transit Custom Bus recited lubricant amount. Ex. 1002 ¶ 403. In particular, we agree with Dr. Brown that, because the lubricant accounts for 26.7% of the AAC refrigerant-lubricant composition in the Ford Transit Custom Bus, the lubricant makes up “about 30%” of the refrigerant-lubricant composition as claimed. Id. For these reasons, we find that Petitioner has met its burden to show that claims 1–20 are unpatentable for anticipation under § 102(a)(1).” slip op. at 55
Patent outcomesUS 9,157,017 unpatentable§ 102 anticipation§ 112 disclosurePatents in suitUS 9,157,017 - Arkema Inc. / Arkema France v. Honeywell International Inc.All claims unpatentablePTAB · Aug 25, 2022 · PGR2016-00011 · APJ Grace Karaffa Obermann · PGR · Remand
Claims 1–20 are unpatentable under § 102(a) for prior public use; the Board did not reach the other anticipation, obviousness, and enablement grounds.
RulingsRemand decision- RemandOther
“On October 1, 2019, the Federal Circuit held that we “abused [our] discretion by assuming the authority that 35 U.S.C. § 255 expressly delegates to the Director: to determine when a Certificate of Correction is appropriate,” and vacated our Final Written Decision. Honeywell Int’l Inc. v. Arkema Inc., 939 F.3d 1345 (Fed. Cir. 2019). The Federal Circuit instructed us to “authorize Honeywell to file a motion seeking leave to petition the Director for a Certificate of Correction.” Id. at 1351. Pursuant to the Federal Circuit’s mandate, we gave our authorization, and Patent Owner filed its Motion for Leave to Request a Certificate of Correction. PGR11 Paper 61; PGR12 Paper 41. After additional briefing from the parties was complete, we granted Patent Owner’s Motion. PGR11 Paper 77; PGR12 Paper 57. Patent Owner filed its Request for a Certificate of Correction, as well as a Petition to Accept [Unintentionally] Delayed Claim to Priority under 35 U.S.C. § 120 and 37 C.F.R. § 1.78. PGR11 Ex. 2174; PGR12 Ex. 2172.” slip op. at 3
- Skill levelSkill level board ownDecided for petitioner
“develops new refrigerants for use as heat transfer fluids. Ex. 1002 ¶ 149. Such a person would have had a Ph.D. in Chemistry, Chemical Engineering, Mechanical Engineering, Material Science, or a related field or discipline and at least 3 to 5 years of experience, or alternatively an M.S. degree and 5 to 10 years of experience. Id. Patent Owner’s Declarant, Dr. Bivens, provides a similar description of the person of ordinary skill in the art, stating that such a person would have a B.S. degree in Chemical Engineering or Chemistry, and five years of work experience, or a Ph.D. or M.S. degree and 2–3 years of experience. Ex. 2001 ¶ 23. Based on these descriptions, we find that the parties’ definitions of ordinary skill in the art are substantially the same, and agree with the parties that an ordinarily skilled artisan would be educated in the Chemical and Chemical Engineering arts or related disciplines. We also agree with the parties that a person having less formal education, such as a B.S. or M.S. degree, would require more years of experience than a person with more formal education, such as a Ph.D., to qualify as an ordinarily skilled artisan. We also find that neither party states how any difference in the parties’ articulated levels of skill impacts this proceeding. Thus, our analysis would be the same regardless of any minor differences between the parties’ respective articulations. Finally, we note that the level of ordinary skill in the art is reflected by the prior art of record. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 20
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateNot shown unpatentable
“We agree with Petitioner that the ’525 application’s statement that the compounds are “adaptable for use” weighs against a finding of adequate written description. First, “adaptable for use” is vague, as Dr. Bivens acknowledges. See Ex. 1177, 151:15 (testifying that “adaptable for use can have a wide range of meaning”). Second, the ’525 application gives no direction on how a skilled artisan would need to adapt any particular composition for use in AAC, or even if any “adaptation” was necessary. We find that such a teaching is important in this case to show that the inventors had possession of the claimed invention, given our findings above that the art of AAC was unpredictable and that a heat-transfer composition for AAC required specific technical features that were unpredictable and unexpected. For completeness, we again reject Patent Owner’s argument that “[t]o show the inventors possessed claim 1 requires no more” than the statement in the written description that “‘the compositions of the present invention are believed to be adaptable . . . with or without system modification.’” PGR12 Resp. 27–28 (quoting Ex. 1001, 7:4–8). Regardless of the exact wording of claim 1, the inventors “still [had to have] describe[d] some way of performing the claimed methods.” Ariad, 598 F.3d at 1355. And here, with merely a passing reference to AAC, the ’525 application fails to provide any credible “technologic knowledge” to demonstrate to an ordinarily skilled artisan that Patent Owner “was in possession of the invention that is claimed.” Id.” slip op. at 43
- Novelty / Anticipation (§102) › Prior-art status of a reference › On-sale bar (Pfaff, Helsinn)UnpatentableUnpatentable
“unless . . . the claimed invention was . . . in public use . . . before the effective filing date of the claimed invention.” 35 U.S.C. § 102(a)(1). “The proper test for the public use prong . . . is whether the purported use was accessible to the public or was commercially exploited.” Delano Farms Co. v. Cal. Table Grape Comm’n, 778 F.3d 1243, 1247 (Fed. Cir. 2015) (quotation omitted). “Commercial exploitation is a clear indication of public use . . . .” Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1380 (Fed. Cir. 2005).” slip op. at 53
Patent outcomesUS 9,157,017 unpatentable§ 102 anticipation§ 112 disclosurePatents in suitUS 9,157,017 - Collegium Pharmaceutical, Inc. v. Purdue Pharma L.P., Purdue Pharmaceuticals L.P., And The P.F. Laboratories Inc.All claims unpatentablePTAB · Nov 19, 2021 · PGR2018-00048 · APJ Devon Zastrow Newman · PGR · Final written decision
Claims 1–17 are unpatentable for lack of written description and anticipation by the ’943 Publication; indefiniteness and lack of enablement were not shown.
RulingsFinal written decision- ExcludeMotion to exclude, deniedDenied
“We are not persuaded that exclusion of the cited portions of Dr. Chambliss’ testimony or Exhibits 1073, 1074, 1075, 1082, 1083, 1084, 1085, 1086, 1088, and 1090 is warranted. While the parties disagree on the merits of Dr. Chambliss’ testimony as to whether PGGs were known to be gelling agents by persons of ordinary skill in the art at the time of the Priority Applications, Patent Owner does not persuade us that Dr. Chambliss fails to support his testimony with any reasonable logical or scientific basis. The exhibits that Patent Owner seeks to exclude, which include a patent, technical references, and a journal article, are relevant to the inquiry Dr. Chambliss performed in forming his opinion. We therefore do not see a basis for exclusion under FRE 702/703 or 37 C.F.R. § 42.64(c). Moreover, we find this evidence both admissible and relevant as it concerns a fundamental issue for our patentability analysis. Thus, we decline to exclude the evidence under FRE 401 or 402.” slip op. at 12
- Skill levelSkill level petitioner adoptedOther
“would have possessed “a degree in one or more fields of medicine, chemical engineering, chemistry, pharmaceutical science, and/or pharmacology and a number of years of industry training or experience in one or more of those fields.” Pet. 21 (citing Ex. 1002 ¶ 82). Petitioner further proposes that “[i]f the degree is a Ph.D[.], then the required industry experience need not be significant, e.g., two years or more, but if the technical degree is a B.S. or M.S., then the industry experience would be more significant, e.g., five years or more.” Id. We preliminarily adopted Petitioner’s definition of a POSA’s skill level in our Institution Decision as it was undisputed at the time and consistent with the evidence of record. Inst. Dec. 7–8. Neither Patent Owner nor Petitioner addresses the level of ordinary skill in the art in the post-institution briefing. We continue to adopt Petitioner’s proposed skill level for a POSA herein and have also taken into account the level of skill reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Applying this level of skill, we find that Dr. Chambliss and Dr. Constantinides are qualified to provide opinions as to the perspective and knowledge of a POSA. See Ex. 1002 ¶¶ 81–83; Ex. 2030 ¶¶ 58–63.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We agree with Patent Owner that the challenged claims recite methods of making formulations using recited features and ingredients. In addition, as we stated in our Decision on Institution, “[t]he claims define abuse deterrence in terms of when the dosage form is ‘subjected to t[a]mpering comprising heating at a temperature greater than about 45° C.’” Inst. Dec. 19 (quoting Ex. 1001, 41:50–52). Additionally, the claims and specification identify specific ingredients that can purportedly help achieve this abuse deterrence functionality. Id. Given these conclusions, further construction of “abuse deterrent,” which both parties generally agree relates to methods of making the drug dosage form less likely to be abused, is not necessary to resolve the issues before us.” slip op. at 9
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable
“Notwithstanding these individual teachings, we find that the specification fails to demonstrate that the inventors of the ’961 patent possessed a dosage form comprising a combination of the recited components that also satisfied the recited functionality. We are persuaded that the specification fails to provide sufficient guidance that would have led the POSA to create the recited dosage form. See Fujikawan 93 F.3d at 1571; In re Ruschig, 379 F.2d 990, 995 (CCPA 1967). Rather, “one is left to select[] from the myriads of possibilities encompassed by the broad disclosure, with no guide indicating or directing that this particular selection should be made rather than any of the many others which could also be made.” Ruschig, 379 F.2d at 995.” slip op. at 34
Patent outcomesUS 9,693,961 unpatentableClaim construction§ 102 anticipation§ 112 disclosurecites NautilusPatents in suitUS 9,693,961 - PTAB · Oct 19, 2021 · IPR2020-00847 · APJ Sheldon M Mcgee · IPR · Final written decision
Claims 1, 2, 4–7, 10, and 14 are unpatentable as obvious over Kurganov-262 and Chakrabarti; the Board did not reach the alternative grounds.
RulingsFinal written decision- BurdenDecided for petitioner
“Turning now to obviousness, Petitioner identified disclosure within Kurgonov-262 and Chakrabarti which teaches or suggests the limitations of claim 1. Pet. 11–21. Furthermore, Petitioner identified multiple reasons that would have prompted the skilled artisan to combine the teachings of Kurganov-262 and Chakrabarti to arrive at the subject matter of claim 1. Id. at 21–22. Because Patent Owner focused its arguments solely on the issue of whether Kurganov-262 is prior art, Petitioner’s assertions regarding the substantive teachings of Kurganov-262 and Chakrabarti remain unrebutted on the complete record. PO Resp. 31–34; Sur-reply 1–3. Patent Owner likewise failed to substantively address Petitioner’s proffered reasons why the skilled artisan would have been motivated to combine these teachings. PO Resp. 31–34; Sur-reply 1–3. We have reviewed the disclosures of Kurganov-262 and Chakrabarti relied on by Petitioner, as well as the explanations provided by Mr. Lipoff, and are persuaded that the limitations of claim 1 are disclosed in the prior art. Pet. 11–21; Ex. 1002 ¶¶ 103–109; Ex. 1004; Ex. 1008. Petitioner also persuades us that the skilled artisan would have been motivated to apply Chakrabarti’s techniques for web crawling to Kurganov-262’s system, and would have had a reasonable expectation of successfully doing so, thus arriving at the subject matter of claim 1 of the ʼ084 patent. Pet. 21–23; Ex. 1002 ¶¶ 110–114. Therefore, Petitioner has shown, by a preponderance of the evidence, that the subject matter of claim 1 of the ʼ084 patent would have been obvious over the combined disclosures of Kurganov-262 and Chakrabarti.” slip op. at 24
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner describes a person having ordinary skill in the art as having “a Bachelor’s degree in electrical engineering, computer science or a related field, and at least two years of experience with voice interfaces and information processing. More education could substitute for less experience, and vice versa.” Pet. 5 (citing Ex. 1002 ¶¶ 41–47). Patent Owner does not contest Petitioner’s definition of the skilled artisan. See generally, PO Resp. Neither party argues that the outcome of this case would differ based on our adoption of any particular definition of one of ordinary skill in the art. Moreover, the level of ordinary skill in the art is also reflected by the references themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he 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.’”); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (finding that the Board of Patent Appeals and Interferences did not err in concluding that the level of ordinary skill in the art was best determined by the references of record). Thus, on the complete record, we accept Petitioner’s assessment of the level of one of ordinary skill in the art. C. Asserted Obviousness based on Kurganov-262 and Chakrabarti” slip op. at 11
- Expert testimonyPatent owner expert discountedDecided for patent owner
“Rather, on the complete record, Patent Owner makes inadequately supported assertions regarding what the skilled artisan “would understand” based on the ʼ084 patent’s disclosure. See PO Resp. 33–34. For example, Patent Owner asserts that “[a] POSITA would understand that” polling or pinging “describes a process where by existing and new devices and/or websites are discovered,” and that “‘polling’ includes asking for information from a website, including a listing of URLs or asking a website of a search engine to provide new website information.” Id. at 34 (citing Ex. 2059 ¶¶ 154–155). We reject this line of argument because we afford minimal weight to Patent Owner’s reliance on paragraphs 153–155 of Exhibit 2059. PO Resp. 33–34. These declaration paragraphs provide little detail beyond what is argued in the Patent Owner Response. See 37 C.F.R. § 42.65 (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”).” slip op. at 22
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateNot shown unpatentable
“We are persuaded by Petitioner’s arguments that sufficient written description support does not exist in the ʼ996 application for “limitation 1.i” which requires the computing device to be “configured to periodically search via the one or more networks to identify new web sites and to add the new web sites to the plurality of web sites.” Pet. 6–11. Thus, we determine that Kurganov-262 is available as prior art against the challenged claims. On the complete record, Patent Owner fails to direct us to specific disclosure within the ʼ996 application that evinces written description for limitation 1.i. Rather, Patent Owner’s citations to the ʼ084 patent fail to describe with adequate precision a computing device configured to periodically search the network(s) to identify new web sites and add such new web sites to the plurality of web sites that are accessed. See PO Resp. 31–34.” slip op. at 20
§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 9,451,084
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.