- Human Power Of N Company v. Heartbeet LtdInstitution deniedPTAB · Feb 25, 2022 · PGR2021-00110 · APJ Devon Zastrow Newman · PGR · Institution
The Board denied institution because Petitioner did not show the ’555 patent was eligible for post-grant review; the challenged claims were entitled to pre-AIA effective filing dates.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“The test for written description support 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” based on an “objective inquiry into the four corners of the specification.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). If this test fails, the application is not entitled to the benefit of the earlier filing date. The written description requirement is satisfied when the specification “set[s] forth enough detail to allow a person of ordinary skill in the art to understand what is claimed and to recognize that the inventor invented what is claimed.” University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 928 (Fed. Cir. 2004). The specification does not have to provide exact or verbatim textual support for the claimed subject matter at issue. Fujikawa v. Wattanasin, 93 F.3d 1559, 1570 (Fed. Cir. 1996). The Federal Circuit has clarified that [a]lthough [the applicant] does not have to describe exactly the subject matter claimed, . . . the description must clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed . . . . The test for sufficiency of support . . . is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter.” Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991) (citations omitted). Moreover, “the written description requirement does not demand either examples or an actual reduction to practice.” Capon v. Eshhar, 418 F.3d 1349, 1352 (Fed. Cir. 2005). “An applicant is not required to describe in the” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner proposes that one of ordinary skill in the art would have had “an M.D. degree or a Ph.D. degree in biochemistry, pharmacology, nutrition chemistry, exercise physiology, or kinesiology, and at least two years of post-doctoral research or clinical experience with physiology, biochemistry, exercise science, or dietary supplements and formulation.” Pet. 16 (citing Ex. 1003 ¶ 21). Patent Owner does not challenge this definition at this time. Prelim. Resp. 7. For purposes of this decision, we apply Petitioner’s proposed definition as it is consistent with the level of skill presented in the ’555 patent and applied art. We also note that the level of ordinary skill in the art at the time of the invention may be reflected in the prior art in this proceeding. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 7
- Expert testimonyPetitioner expert discountedDecided for patent owner
“We are unpersuaded that Dr. Volek’s reliance on Exhibit 1066 as the sole source of his conclusion that certain doses of inorganic nitrate would have been lethal in the context of the claimed methods is sufficient to establish undue experimentation under the Wands factors. As Patent Owner argues, the working example disclosed in PCT1 discloses administration of a dose Dr. Volek states would have been lethal, but was not. Rather, the result of that experiment was a demonstrated decrease in glucose consumption by the participants, a benefit of increased endurance. Ex. 1008 ¶ 106. We agree with Patent Owner that this case is distinguishable from those cited by Petitioner for the reasons explained by Patent Owner (Prelim. Resp. 31–33), and also from the recent case by our reviewing court, Amgen, Inc. v. Sanofi, 987 F.3d 1080 (Fed. Cir. 2021). In Amgen, the court found the claims lacked enablement because the claims recited dual functional limitations, and potentially millions of antibody candidates could be found to fall within those limitations. Id. at 1088. The court found the examples provided in the specification insufficient to enable the full scope of the claims given the high effort required to screen and identify all such antibodies. Id. Here, as Patent Owner has observed, the only effort required to practice claims within the range in light of the working example is to “simply administer a different dosage to the human for which increased exercise endurance is desired,” which would have been within the scope of the ordinarily skilled artisan. Prelim. Resp. 31. Moreover, Patent Owner correctly notes that methaemoglobinaemia15, the source of the lethality cited in Exhibit 1066, does not result via the claimed method. Prelim. Resp. 30, citing Ex. 1066 at 14–15. As Patent Owner explains, Petitioner’s sole cited Exhibit, 1066, discloses a risk of development of methaemoglobinaemia, a condition where more than 10% of the haemoglobin is transformed into methaemoglobin.” Id. When the conversion to haemoglobin exceeds 70% the condition can be fatal.” Ex. 1066 at 14–15. Patent Owner explains that the inventors discussed the risk of development of methaemoglobinaemia, and explained in PCT1 that their methods do not cause a significant rise in the methemoglobin level in the test subjects. Prelim. Resp. 30. Moreover, PCT1 discloses a working example where three test subjects were given a dose in the range Petitioner alleges would be lethal, with no ill result. Id., citing Ex. 1008 ¶ 106. Dr. Volek’s failure to address this discrepancy, or to provide alternate sources to explain why his conclusion is nonetheless correct, merits his brief testimony on this issue be assigned little probative” slip op. at 20
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“G. Claim Construction In a post-grant review, we apply the same claim construction standard as would be used by a district court to construe a claim in a civil action involving the validity or infringement of a patent. 37 C.F.R. § 42.200(b) (2020). Under that standard, claim terms are given their ordinary and customary meaning, as would have been understood by a person of ordinary skill in the art at the time of the invention, in light of the language of the claims, the specification, and the prosecution history of record. Id.; Phillips v. AWH Corp., 415 F.3d 1303, 1312–19 (Fed. Cir. 2005) (en banc); Thorner v. Sony Comput. Entm’t Am. LLC, 669 F.3d 1362, 1365–66 (Fed. Cir. 2012). Pet. 23–24. Patent Owner does not propose a construction for “inorganic nitrate.” Prelim Resp. 8–9. For purposes of determining whether to institute trial of the challenged claims, we determine it is not necessary to construe “inorganic nitrate.” Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in the context of an AIA proceeding).” slip op. at 7
Claim construction§ 112 disclosurecites PhillipsPatents in suitUS 10,835,555 - PTAB · Feb 9, 2022 · IPR2022-00298 · APJ Erica A Franklin · IPR · Institution
The Board instituted review of claims 1, 3–11, 13, 14, 16–24, and 26 on six grounds and granted Apotex’s motion to join the Mylan IPR.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In view of these representations by Petitioner, and having reviewed the Apotex Petition, we determine that, under the current circumstances, it is appropriate to exercise our discretion to institute inter partes review of the challenged claims based upon the same ground authorized and for the same reasons discussed in our Institution Decision in the Mylan IPR. See Mylan IPR, Paper 21.” slip op. at 4
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Petitioner timely filed its Joinder Motion within one month of the institution of the Mylan IPR, as required by 37 C.F.R. § 42.122(b). In the Joinder Motion, Petitioner explains that it will: assume a “silent understudy” role and will not take an active role in the inter partes review proceeding unless the Mylan Petitioner ceases to participate in the instituted IPR. Thus, the proposed joinder will neither unduly complicate the Mylan IPR nor delay its schedule. As such, the joinder will promote judicial efficiency in determining patentability in the Mylan IPR without prejudice to Patent Owner.” slip op. at 5
NonePatents in suitUS 9,254,338 - PTAB · Feb 9, 2022 · IPR2022-00258 · APJ Erica A Franklin · IPR · Institution
The Board instituted review of claims 1, 3–11, 13, 14, 16–24, and 26 on six grounds and granted Celltrion’s motion to join the Mylan IPR.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In view of these representations by Petitioner, and having reviewed the Celltrion Petition, we determine that, under the current circumstances, it is appropriate to exercise our discretion to institute inter partes review of the challenged claims based upon the same grounds authorized and for the same reasons discussed in our Institution Decision in the Mylan IPR. See Mylan IPR, Paper 21.” slip op. at 4
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“assume a “silent understudy” role and will not take an active role in the inter partes review proceeding unless the Mylan Petitioner ceases to participate in the instituted IPR. Thus, the proposed joinder will neither unduly complicate the Mylan IPR nor delay its schedule. As such, the joinder will promote judicial efficiency in determining patentability in the Mylan IPR without prejudice to Patent Owner.” slip op. at 5
NonePatents in suitUS 9,254,338 - PTAB · Feb 9, 2022 · IPR2022-00257 · APJ John G New · IPR · Institution
The Board instituted review of claims 1 and 8–12 on five anticipation and obviousness grounds and granted Celltrion’s motion to join the Mylan IPR as a secondary participant.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Celltrion’s Petition is substantially identical to Mylan’s Petition, challenging the same patent and claims, based on the same grounds of unpatentability, and relying upon the same evidence (including the same 2 James A. Dixon et al., “VEGF Trap-Eye for the treatment of neovascular age-related macular degeneration,” 18(10) Expert Opin. Investig. Drugs 1573–1580 (2009) (Ex. 1006, “Dixon”)). 3J.S. Heier, Intravitreal VEGF Trap for AMD: An Update, October 2009 RETINA TODAY 44–45 (2009) (“Heier 2009”) Ex. 1020. 4 Press Release, Bayer and Regeneron Extend Development Program for VEGF Trap-Eye to Include Central Retinal Vein Occlusion, April 30, 2009 (“Regeneron I”) Ex. 1028. 5 P. Mitchell et al., Ranibizumab (Lucentis) in Neovascular Age-Related Macular Degeneration: Evidence from Clinical Trials, 94(2) Br. J. Ophthalmol. 2–13 (2010) (“Mitchell”) Ex. 1030. 6 Papadopoulos et al. (US 7,374,758 B2, May 20, 2008) (“Papadopolous”) Ex. 1010. 7 Dix et al., (US 2006/0217311 A1, May 20, 2008) (“Dix”) Ex. 1033. prior art combinations supported by the same expert declaration) as the Mylan IPR. See Mot. 1. Petitioner seeks only institution of the same claims and grounds for which the Board instituted in the Mylan IPR. Id.” slip op. at 3
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Petitioner timely filed its Joinder Motion within one month of the institution of the Mylan IPR, as required by 37 C.F.R. § 42.122(b). In the motion, Petitioner explains that it will: assume a “silent understudy” role and will not take an active role in the inter partes review proceeding unless the Mylan Petitioner ceases to participate in the instituted IPR. Thus, the proposed joinder will neither unduly complicate the Mylan IPR nor delay its schedule. As such, the joinder will promote judicial efficiency in determining patentability in the Mylan IPR without prejudice to Patent Owner. Mot. 1. As discussed in the Institution Decision, Section II supra, the instituted grounds in this proceeding are the same as that instituted in the Mylan IPR. Having considered the unopposed motion for joinder, and our decision to institute the same grounds in the Mylan IPR, we determine that Petitioner Celltrion has established persuasively that joinder is appropriate and will have little to no impact on the timing, cost, or presentation of the trial on the instituted ground. Thus, in consideration of the foregoing, and in the manner set forth in the following Order, the Motion for Joinder is GRANTED.” slip op. at 5
NonePatents in suitUS 9,669,069 - PTAB · Feb 9, 2022 · IPR2022-00301 · APJ John G New · IPR · Institution
The Board instituted review of claims 1 and 8–12 on five grounds and granted Apotex’s motion to join the Mylan IPR, with Apotex in a secondary role.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“In view of these representations by Petitioner, and having reviewed the Apotex Petition, we determine that, under the current circumstances, it is appropriate to exercise our discretion to institute inter partes review of the challenged claims based upon the same grounds authorized and for the same reasons discussed in our Institution Decision in the Mylan IPR. See Mylan IPR, Paper 21.” slip op. at 4
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Having considered the unopposed motion for joinder, and our decision to institute the same grounds in the Mylan IPR, we determine that Petitioner Apotex has established persuasively that joinder is appropriate and will have little to no impact on the timing, cost, or presentation of the trial on the instituted ground. Thus, in consideration of the foregoing, and in the manner set forth in the following Order, the Motion for Joinder is GRANTED.” slip op. at 6
NonePatents in suitUS 9,669,069 - Slayback Pharma LLC v. Sumitomo Dainippon Pharma Co., Ltd.All claims unpatentablePTAB · Jan 20, 2022 · IPR2020-01053 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1–75 are unpatentable as obvious over Saji; the Board did not reach the Latuda Information anticipation or Latuda Information and Loebel obviousness grounds.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“We do not discern an appreciable difference in the parties’ respective definitions of the level of ordinary skill in the art, and any perceived distinction does not impact our Decision. Indeed, as Patent Owner acknowledges, the parties’ proposed definitions of the ordinary skill level do “not differ significantly.” Id. at 25. Nevertheless, for purposes of this Decision, we adopt Patent Owner’s definition of the skill level, as it is consistent with the ’827 patent disclosures and the prior art of record, and more inclusively describes the suitable experience for one of ordinary skill in the art. We further note that, in this case, the prior art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“On this record, we find Petitioner’s proposed constructions are supported by intrinsic and extrinsic evidence. See Pet. 18–23. We agree with Petitioner here that “a patient” or “the patient” should have its ordinary and customary meaning of “one or more patients,” as opposed to a “patient population” as Patent Owner has previously argued in a district court litigation involving another party. See id. at 19–20. Indeed, Patent Owner agrees. See Reply 19 (“There is no dispute that ‘a patient,’ as recited in the ’827 claims, refers to ‘one or more patients.’”). We also agree with Petitioner that the dependent claims requiring treating patients with schizophrenia and manic depressive psychosis supports the conclusion that “treating a patient with an antipsychotic” in independent claims 25, 40, and 56 includes treatment of a patient with these particular diseases. See Pet. 20–21. 10 On this record, we further agree with Petitioner that “manic depressive psychosis” would be interpreted by a person or ordinary skill in the art as “bipolar disorder,” which includes Bipolar I Disorder, Bipolar II Disorder, Cyclothymia, and Bipolar Disorder Not Otherwise Specified. See id. at 21–22 (citations omitted); see also PO Resp. 3 (“Bipolar disorder, once known as manic depressive psychosis.”). Thus, for purposes of this Decision, we adopt Petitioner’s proposed constructions.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“On this record and for purposes of this Decision, we see no need to construe any other term expressly. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating that claim terms need only be construed to the extent necessary to resolve the controversy).” slip op. at 11
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
Patent outcomesUS 9,815,827 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,815,827 - Neurocrine Biosciences, Inc. v. Spruce Bosciences, Inc.Institution deniedPTAB · Dec 10, 2021 · PGR2021-00088 · APJ John G New · PGR · Institution
The Board denied institution on all five grounds, finding the petition did not show any challenged claim was likely unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Under 35 U.S.C. § 324, the Board “may not authorize a post-grant review to be instituted unless … the information presented in the petition … if such information is not rebutted would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon consideration of the Petition, the Preliminary Response, and the evidence presently before us, we determine that Petitioner has failed to demonstrate that it is more likely than not that it would prevail in establishing the unpatentability of at least one challenged claim of the ’908 patent. We consequently deny institution of post-grant review.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“The Specification expressly teaches that, with respect to the clinical phase 2 trial described in Example 4, “Patients will have overnight [pharmacokinetic/pharmacodynamics] PK/PD assessments performed at baseline, which include an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose.” Ex. 1001 col. 42, ll. 12–16. This is the same quotation and clinical trial relied upon by Dr. Barnes in his Declaration, and is the only definition of a “baseline” in the ’908 patent. See Ex. 1002, 36–37. We note that placebos were evidently not employed in the phase 2 clinical study of Example 4.3 Given the sole exemplary description of “baseline” in Example 4 of the Specification, we construe the claim term reciting “reduced by at least 10% from baseline” as meaning “a reduction of at least 10% in the level of ACTH (claim 1) or 17-OHP (claim 11) compared to measurements of ACTH or 17-OHP made prior to, and/or at the beginning of, administration of the drug.”” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“likely than not that independent claims 1 and 11 are anticipated by Grigoriadis. “For a claim to be anticipated, each claim element must be disclosed, either expressly or inherently, in a single prior art reference, and the claimed arrangement or combination of those elements must also be disclosed, either expressly or inherently, in that same prior art reference.” Therasense, Inc. v. Becton, Dickinson and Co., 593 F.3d 1325, 1332–33 (Fed. Cir. 2010). The single clinical trial taught by Example 6 of Grigoriadis does not establish a baseline value for patients against which to compare the data obtained from patients receiving 300 mg or 600 mg of the test drug, NBI- 77860 (verucerfont). See Ex. 1006 ¶¶ 90–94. Specifically, Example 6 does not establish a baseline “which include[s] an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose,” as disclosed by the ’908 patent. See Ex. 1001, col. 42, ll. 12–16. We therefore conclude that Grigoriadis fails to disclose expressly the limitations of claims 1 and 11 severally reciting “wherein [the] … hormone … level in the human is reduced by at least 10 % from baseline.”” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable
“A reference may anticipate if a claim limitation that is not expressly disclosed is inherently disclosed because it “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010); see also Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (holding that the “very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question”).” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,849,908 - Slayback Pharma LLC v. Sumitomo Dainippon Pharma Co., Ltd.All claims unpatentablePTAB · Dec 7, 2021 · IPR2020-01053 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1–75 are unpatentable as obvious over Saji; the Board did not reach the Latuda Information anticipation and Latuda Information–Loebel obviousness grounds.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“We do not discern an appreciable difference in the parties’ respective definitions of the level of ordinary skill in the art, and any perceived distinction does not impact our Decision. Indeed, as Patent Owner acknowledges, the parties’ proposed definitions of the ordinary skill level do “not differ significantly.” Id. at 25. Nevertheless, for purposes of this Decision, we adopt Patent Owner’s definition of the skill level, as it is consistent with the ’827 patent disclosures and the prior art of record, and more inclusively describes the suitable experience for one of ordinary skill in the art.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“On this record, we find Petitioner’s proposed constructions are supported by intrinsic and extrinsic evidence. See Pet. 18–23. We agree with Petitioner here that “a patient” or “the patient” should have its ordinary and customary meaning of “one or more patients,” as opposed to a “patient population” as Patent Owner has previously argued in a district court litigation involving another party. See id. at 19–20. Indeed, Patent Owner agrees. See Reply 19 (“There is no dispute that ‘a patient,’ as recited in the ’827 claims, refers to ‘one or more patients.’”).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“On this record and for purposes of this Decision, we see no need to construe any other term expressly. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating that claim terms need only be construed to the extent necessary to resolve the controversy).” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“Based on Saji’s preferred dose range of 5 to 100 mg/day, which overlaps with the “from 20 to 120 mg/day” range required by each challenged independent claim, Petitioner argues that an ordinarily skilled artisan would have been “motivated to conduct dose ranging studies and would find the claimed dosing regimens.” Pet. 62; see also id. at 55 (contending that “dose ranging was a routine part of drug development” (citing Ex. 1030)). Dr. Stahl’s testimony supports Petitioner’s argument. Indeed, Dr. Stahl testifies that, although with some drugs, it can be difficult to find a safe and effective dose, or to get an effective dose into the patient, neither is the case with lurasidone. Ex. 1054, 141:3–14; see also id. at 142:2–6 (“Q. [A]re you aware of any particular difficulties with lurasidone hydrochloride and finding a safe and effective dose for schizophrenia and manic depressive psychosis? A. No.”); 135:18–25 19 (Dr. Stahl testifying that he is “not aware of anything unusual about [lurasidone’s] dose range”). Thus, we agree with Petitioner that an ordinarily skilled artisan, starting from Saji’s preferred dosing range, would have conducted routine dose ranging studies and identified the claimed dosing regimens.” slip op. at 19
Patent outcomesUS 9,815,827 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,815,827 - PTAB · Nov 10, 2021 · IPR2021-00880 · APJ John G New · IPR · Institution
The Board instituted inter partes review on all challenged claims and grounds, finding a reasonable likelihood that claims 1 and 9–12 are anticipated by Dixon or Heier 2009.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Becton-Dickinson factors (a), (b), and (d) have been satisfied. The evidence of record shows that the Dixon reference before the Examiner consisted of merely the first page of Dixon. See Ex. 1087. The single page of Dixon that 8 Thomas Reuters Integrity, VEGF Trap-Eye Final Phase II Results in Age-Related Macular Degeneration Presented at 2008 Retina Society Meeting, (Sep. 28, 2008). Ex. 2007. was before the Examiner provides no disclosure of the claimed dosing regimen. It would consequently have been impossible for the Examiner to analyze the limitations of the challenged claims in view of the complete teachings of Dixon under these circumstances. We consequently find that the disclosure of Dixon that form the basis of Petitioner’s Grounds I and IV (of which Dixon is the sole reference) were not before the Examiner as prior art during examination (because the relevant disclosures were missing or omitted), and that there could therefore be no overlap between the arguments made during examination and the manner in which Petitioner relies on the prior art or Patent Owner distinguishes the prior art.” slip op. at 12
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“c. Analysis We conclude that Petitioner has established a reasonable likelihood of success in prevailing at trial on Grounds 1 and 2, and that Patent Owner’s arguments are insufficient, based upon the current record, to overcome that likelihood of success. Petitioner’s claim chart maps out the correspondence between the limitations of claim 1 and the disclosures of Dixon and Heier 2009 in a manner that persuasively demonstrates that the disclosures of both references disclose all of the limitations. Patent Owner does not dispute Petitioner’s showing that the references anticipate, with three exceptions. We address each of those arguments in turn.” slip op. at 30
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundInstituted
“Ex. 1006, 4 (emphasis added). Dixon thus expressly discloses that patients were treated on a “p.r.n. basis” (i.e., an “as needed basis”) for additional doses, and details the criteria by which the physical symptoms were assessed to determine whether another dose was warranted. It is true that Dixon does not expressly state that it is a physician who performs this assessment of the patient in question. But we find that a person of ordinary skill in the art, as defined by Petitioner, would understand that the preforming of diagnostic procedures and analysis, and the prescription of the appropriate medication, would necessarily need to be performed by a physician or other qualified medical professional licensed by 12 Patent Owner also argues that, contra Petitioner’s assertion, this limitation is a positive limitation of the claim that should be afforded patentable weight. See Prelim. Resp. 20–24. For the purposes of this Decision, we accept Patent Owner’s contention that the limitation reciting “assessed by a physician or other qualified medical professional” is entitled to patentable weight. As we explain, however, Patent Owner’s argument that this limitation is not disclosed by the cited prior art is unpersuasive. the state. That is, almost by definition, the practice of medicine, and is certainly well known in this art. See In re Graves, 69 F.3d 1147, 1152 (Fed. Cir. 1995) (holding that the teachings of a reference may be taken in combination with knowledge of the skilled artisan to put the artisan in possession of the claimed invention within 35 U.S.C. § 102 even though the patent does not specifically disclose certain features); see also Continental Can, 948 F.2d at 1269 (holding that anticipation requirement that every element of a claim appears in a single reference accommodates situations where the common knowledge of “technologists” is not recorded in a reference, i.e., where technical facts are known to those in the field of the invention). We therefore find that a person of ordinary skill in the art, as defined by Petitioner, would understand that only a licensed physician could competently perform the procedures disclosed by Dixon in the quoted passage.” slip op. at 31
- Skill levelSkill level petitioner adoptedDecided for petitioner
“equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field), with practical academic or medical experience in (1) developing treatments for angiogenic eye disorders (such as AMD), including through the use of VEGF antagonists, or (2) treating of angiogenic eye disorders (such as age-related macular degeneration (“AMD”)), including through the use of VEGF antagonists. Pet. 25 (citing Ex.1002 ¶¶ 26–28). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Preliminary Response, although Patent Owner contends that such a skilled artisan could not necessarily perform the limitation of claim 1 reciting “based on visual and/or anatomical outcomes as assessed by a physician or other qualified medical professional.” See, e.g., Prelim. Resp. 28. We address Patent Owner’s contentions with respect to this limitation in our analysis below. For the purposes of this decision, because we find Petitioner’s definition to be consistent with the level of skill in the art (see, e.g., Exs. 1006, 1020), and in the absence of a different proposed definition of the level of skill in the art by Patent Owner, we consequently adopt Petitioner’s definition.” slip op. at 8
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 9,669,069 - PTAB · Nov 10, 2021 · IPR2021-00881 · APJ Erica A Franklin · IPR · Institution
The Board instituted IPR on claims 1, 3–11, 13, 14, 16–24, and 26 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“during the prosecution of the ’338 patent, the Examiner was presented with the information disclosed in the 2008 Press Release for “VEGF Trap-Eye final phase II results in age-related macular degeneration presented at 2008 Retina Society Meeting.” Applicant included the Thomson Reuters description of the press release on the IDS, Ex. 1017, 60–61, along with the submission of the Thomson Reuters publication, Ex. 2007, referenced therein. The Thomson Reuters publication expressly identified the press release by name and date as the “Reference” for the information described in the publication, as well as by the title of the press release. Ex. 2007. Importantly, the Thomson Reuters publication also provided a summary description of the contents of the press release, in a form that resembles an abstract. The contents of the Thomson Reuters publication provides the regimen for VEGF Trap-Eye as each of the cited references relied upon by Petitioner for its anticipation and obviousness challenges.” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314 (2018). Upon considering the parties’ arguments and evidence, we determine that Petitioner has demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of claims 1, 3–11, 13, 14, 16–24, and 26 of the ’338 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art at the time of the invention would have had (1) knowledge regarding the diagnosis and treatment of angiogenic eye disorders, including the administration of therapies to treat said disorders; and (2) the ability to understand results and findings presented or published by others in the field, including the publications discussed herein. Typically, such a person would have an advanced degree, such as an M.D. or Ph.D. (or equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field), with practical academic or medical experience in (i) developing treatments for angiogenic eye disorders (such as AMD), including through the use of VEGF antagonists, or (ii) treating of same, including through the use of VEGF antagonists.” slip op. at 15
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“the current record, that the preamble reciting “[a] method for treating an angiogenic eye disorder in a patient” is limiting. Although we agree with Petitioner that the preamble sets forth “‘a statement of purpose or intended’ use for the claimed dosing regimen,” the Federal Circuit has recently articulated that its case law does not support a “binary distinction between statements of mere intended purpose on the one hand and limiting preambles on the other.” Eli Lilly and Company v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1340 (Fed. Cir. 2021). Indeed, the Federal Circuit reiterated that “there is no ‘litmus test’ for determining whether a preamble is limiting.” Id. (citing Bicon, Inc. v. Straumann Co., 441 F.3d 945, 952 (Fed. Cir. 2006) and Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002)). As the Court instructed, we determine whether to treat a preamble as a claim limitation based upon “the facts [in this] case in light of the claim as a whole and the invention described in the patent.” Id. (quoting Storage Tech. Corp. v. Cisco Sys., Inc., 329 F.3d 823, 831 (Fed. Cir. 2003)). With that said, the Court explained that “while there is no bright-line rule, it is instructive that this court has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound.” Id. at 1342. a VEGF antagonist for the specific purpose of treating an angiogenic eye disorder in a patient. The Specification repeatedly characterizes the method as one that is useful for treating angiogenic eye disorders in patients. See Ex. 1001, 1: 18–20, 63–66, 2:23–27; 3:19–20; 5:11–13. Apart from the preamble, the independent claims do not elsewhere recite or indicate the usefulness of the method steps. Thus, we agree with Patent Owner that the preamble sets forth the essence of the invention. Prelim. Resp. 32. In Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339 (Fed. Cir. 2003), the Federal Circuit explained that “preamble language will limit the claim if it recites not merely a context in which the invention may be used, but the essence of the invention without which performance of the recited steps is nothing but an academic exercise,” and that this principle frequently holds true for method claims. Id. at 1345 (citing Griffin v. Bertina, 285 F.3d 1029, 1033 (Fed. Cir. 2002)). We also agree with Patent Owner that the preamble provides antecedent basis for claim terms “the patient” recited in the body of each independent claims, and “angiogenic eye disorders” recited in dependent claims 6, 7, 18, and 20. Prelim. Resp. 34–35. As Patent Owner asserts, without the preamble, it would be unclear to whom the doses of VEGF are administered. See id. at 35. Thus, in view of Federal Circuit case law regarding statements of intended purpose in claims directed to method of using compositions, and in view of the evidence of record, namely, the claim language and the written description of the ’338 patent, we preliminarily find that the preambles of claims 1 and 14 are limiting.” slip op. at 18
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,254,338
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.