- PTAB · Mar 13, 2023 · IPR2022-01302 · APJ Bart A Gerstenblith · IPR · Institution
The Board instituted review of claims 1, 14–20, 23–33, 35, and 41–44 on all petition grounds, finding a reasonable likelihood claim 1 is obvious over Gottschalk and Kramer.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“An inter partes review may be instituted only if “the information presented in the petition . . . and any [preliminary] response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). For the reasons below, Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one of the Challenged Claims. Accordingly, we institute an inter partes review of the Challenged Claims on all grounds raised in the Petition.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“Memo states that it may be useful to compare a trial date with evidence of a median time to trial. Director’s Memo 8. The purpose of doing so is to ascertain the likelihood of the scheduled trial date actually occurring on or around that date. Id. at 8 (“Stakeholders correctly noted that scheduled trial dates are unreliable and often change[,]” and a “scheduled trial date . . . is not by itself a good indicator of [when] the district court trial will occur.”). The Director’s Memo does not state that median time-to-trial statistics are themselves a trial date, or otherwise replace consideration of a trial date under Fintiv factor 2. And, in the circumstances here, where the case was transferred from the Western District of Texas, the usefulness of the median time to trial statistics is less clear. Ultimately, though, we will not speculate on when a trial may be scheduled. Accordingly, factor 2 favors not exercising our discretion to deny institution.” slip op. at 18
- Parallel petitionsDecided for petitioner
“sufficiently address all the challenged claims” of the ’068 patent. Notice 1. According to Petitioner, Gentex asserted a large number of claims in the parallel litigation “that are distinct from one another, that collectively comprise several thousand words of claim language.” Id. Petitioner ranks this Petition as “A” and the Petition in IPR2022-01303 as “B.” Id. at 1–2. Petitioner also explains its reasoning for the grouping of the claims challenged in each petition and that the only overlap between the two petitions is claim 1, from which a large number of claims depend. Id. at 3–4. Patent Owner did not file a response to the Notice. Nor did Patent Owner otherwise dispute Petitioner’s contentions that two petitions are necessary. See generally Prelim. Resp. On the present record, we see no reason to exercise our discretion to deny institution of either petition on the basis of Petitioner filing two petitions to address the large number of claims asserted in the related litigation. See PTAB Consolidated Trial Practice Guide, 59 (Nov. 2019)10 (recognizing that one circumstance in which more than one petition may be necessary is when a patent owner asserts a large number of claims in related litigation).” slip op. at 21
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“In this case, claim 1 recites mounting “a sourceless orientation tracker on a user’s head.” Ex. 1001, 15:5–6. There is no further reference to “sourceless orientation tracker” in claim 1. Id. Claim 11 recites “[t]he method of claim 1 in which the sourceless orientation tracker comprises an inertial sensor”; claim 12 recites “[t]he method of claim 1 in which the sourceless orientation tracker comprises a tilt-sensor”; and claim 13 recites “[t]he method of claim 1 in which the sourceless orientation tracker comprises a magnetic compass sensor.” Id. at 15:35–40. The parties have not identified and we do not discern anything in the language of the claims that suggests we should deviate from the plain and ordinary meaning of “sourceless orientation tracker.” We now turn to the Specification of the ’068 patent. The Specification states that “[v]irtual reality (VR) systems require tracking of the orientation and position of a user’s head and hands with respect to a world coordinate frame.” Ex. 1001, 1:11–13. The Specification also describes “a variety of mechanical, acoustic, magnetic, and optical systems” used for such tracking and states that “[t]hese systems require propagation of a signal between a fixed ‘source’ and the tracked ‘sensor,’” which “limit[s] the range of operation.” Id. at 1:15–20. The Specification describes that “‘[s]ourceless’ orientation trackers have been developed based on geomagnetic and/or inertial sensors.” Id. at 1:26–27. And, the Specification explains that “the invention features a sourceless orientation tracker including an inertial sensor, a tilt-sensor, or a magnetic compass sensor.” Id. at 2:6–8.” slip op. at 14
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 6,757,068 - PTAB · Mar 13, 2023 · IPR2022-01301 · APJ Arthur M Peslak · IPR · Institution
The Board instituted IPR on all challenged claims and grounds after finding a reasonable likelihood that claim 20 was obvious over Gottschalk, Kramer, and Billinghurst.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“Fintiv factor 2 discusses consideration of a trial date. The Director’s Memo states that it may be useful to compare a trial date with evidence of a median time to trial. Director’s Memo 8. The purpose of doing so is to ascertain the likelihood of the scheduled trial date actually occurring on or around that date. Id. at 8 (“Stakeholders correctly noted that scheduled trial dates are unreliable and often change[,]” and a “scheduled trial date . . . is not by itself a good indicator of [when] the district court trial will occur.”). The Director’s Memo does not state that median time-to-trial statistics are themselves a trial date, or otherwise replace consideration of a trial date under Fintiv factor 2. And, in the circumstances here, where the case was transferred from the U.S. District Court for the Western District of Texas, the usefulness of the median time to trial statistics is less clear. Ultimately, though, we will not speculate on when a trial may be scheduled. Accordingly, factor 2 favors not exercising our discretion to deny institution.” slip op. at 11
- Parallel petitionsDecided for petitioner
“On the present record, we see no reason to exercise our discretion to deny institution of either petition on the basis of Petitioner filing two petitions to address the large number of claims asserted in the related litigation. See PTAB Consolidated Trial Practice Guide, 59 (Nov. 2019)10 (recognizing that one circumstance in which more than one petition may be 10 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated. necessary is when a patent owner asserts a large number of claims in related litigation).” slip op. at 14
- Skill levelSkill level petitioner adoptedDecided for petitioner
“D. Level of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art “would have had a bachelor’s degree in computer science, or an equivalent field, and three to five years of experience working with computer implemented tracking systems, virtual reality systems, and/or augmented reality systems” but that “[a]dditional education might compensate for less experience and vice-versa.” Pet. 24–25 (citing Ex. 1005 ¶¶ 48–49). Patent Owner, at this stage of the proceeding, does not dispute Petitioner’s definition of the person of ordinary skill in the art. Prelim. Resp. 4. Patent Owner further states, “[h]owever, for any other purpose, Patent Owner disagrees with Petitioner at least that such [person of ordinary skill in the art] would be limited to a maximum of five years of experience.” Id. at 5. And, Patent Owner further “reserves the right to offer an alternative definition based on expert evidence in the event the Petition is instituted.” Id. For the purposes of this Decision, we apply Petitioner’s proposed level of skill in the art because it appears consistent with the problems addressed in the ’648 patent and the prior art.” slip op. at 15
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“For the following reasons, we determine, based on the present record, that the term “sourceless orientation tracker” should be given its plain and ordinary meaning, i.e., an orientation tracker that does not require a source.” slip op. at 18
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 7,301,648 - PTAB · Mar 13, 2023 · IPR2022-01298 · APJ Arthur M Peslak · IPR · Institution
The Board instituted IPR on claims 1, 2–12, 16–18, and 38 on all petitioned grounds, finding a reasonable likelihood that claim 1 would be obvious over Gottschalk and Kramer.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“Memo states that it may be useful to compare a trial date with evidence of a median time to trial. Director’s Memo 8. The purpose of doing so is to ascertain the likelihood of the scheduled trial date actually occurring on or around that date. Id. at 8 (“Stakeholders correctly noted that scheduled trial dates are unreliable and often change[,]” and a “scheduled trial date . . . is not by itself a good indicator of [when] the district court trial will occur.”). The Director’s Memo does not state that median time-to-trial statistics are themselves a trial date, or otherwise replace consideration of a trial date under Fintiv factor 2. And, in the circumstances here, where the case was transferred from the Western District of Texas, the usefulness of the median time to trial statistics is less clear. Ultimately, though, we will not speculate on when a trial may be scheduled. Accordingly, factor 2 favors not exercising our discretion to deny institution.” slip op. at 11
- Parallel petitionsDenied
“sufficiently address all the challenged claims” of the ’648 patent. Not. 1. According to Petitioner, “Patent Owner, via an exclusive licensee,” asserted a large number of claims in co-pending litigation “that are distinct from one another, that collectively comprise several thousand words of claim language.” Id. Petitioner ranks this Petition as “A” and the Petition in IPR2022-01301 as “B.” Id. at 1–2.” slip op. at 14
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“obviousness] involves the weighing of the fact findings to conclude whether the claimed combination would have been obvious to an ordinary artisan.” Arctic Cat, 876 F.3d at 1361. On balance, considering the record presently before us, which includes Petitioner’s strong showing regarding claim 1 and Patent Owner’s weaker evidence of nonobviousness, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing that the combination of Gottschalk and Kramer would have rendered the subject matter of claim 1 of the ’648 patent obvious to one of ordinary skill in the art at the time of the invention. 6. Summary of Claim 1 For all the foregoing reasons, we determine that Petitioner has shown a reasonable likelihood that claim 1 would have been obvious over the combined teachings of Gottschalk and Kramer.” slip op. at 37
- Skill levelSkill level petitioner adoptedDecided for petitioner
“have had a bachelor’s degree in computer science, or an equivalent field, and three to five years of experience working with computer implemented tracking systems, virtual reality systems, and/or augmented reality systems” but that “[a]dditional education might compensate for less experience and vice-versa.” Pet. 24–25 (citing Ex. 1005 ¶¶ 48–49). For purposes of this proceeding, Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill in the art. Prelim. Resp. 6. Patent Owner further states, “[h]owever, for any other purpose, Patent Owner disagrees with Petitioner at least that such [person of ordinary skill in the art] would be limited to a maximum of five years of experience.” Id. at 6. And, Patent Owner further “reserves the right to offer an alternative definition based on expert evidence in the event the Petition is instituted.” Id. For the purposes of this Decision, we apply Petitioner’s proposed level of skill in the art because it appears consistent with the problems addressed in the ’648 patent and the prior art.” slip op. at 15
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 7,301,648 - Apotex Inc. v. Regeneron Pharmaceuticals, Inc.Institution deniedPTAB · Mar 10, 2023 · IPR2022-01524 · APJ Ryan H Flax · IPR · Institution
Institution denied because Petitioner did not show a reasonable likelihood that claims 1–14 and 26–30 were unpatentable over the asserted anticipation and obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“APPLICABLE LEGAL STANDARDS “In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). An inter partes review may be instituted if the information presented by Petitioner in the Petition, in view of Patent Owner’s Preliminary Response and the preliminary record, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. 35 U.S.C. § 314.” slip op. at 19
- BurdenDecided for patent owner
“As an initial matter, we find Petitioner has insufficiently addressed the issue of inherent anticipation by Dixon (or any other prior art) and has done so in a merely conclusory manner. There is no dispute that Dixon (as well as the other asserted prior art) discloses angiogenic eye disorder treatment using the same drug (aflibercept), at the same dose (2 mg), administered in the same way (intravitreal injection), and administered at the same dosing regimen (an initial, a secondary, and a tertiary dose), as required by all challenged claims. See generally Pet.; Prelim. Resp. Petitioner relies on these facts, and the results of a phase 2 clinical trial that followed a different dosing protocol (one not claimed) to establish that the results limitations of claims 1, 26, and 29 are inherent to the phase 3 clinical trials (VIEW 1 and 2) with a dosing regimen that is claimed. See Pet. 38–39. Petitioner calls the claimed results limitations mere newly discovered results of a known process. Id. (citing Montgomery, 677 F.3d at 1381). As Patent Owner identifies, it is not so simple. The evidence of the results of the VIEW 1 and 2 trials itself (found in the ’572 patent) shows that some, but not all, patients treated with the claimed dosing regimen achieved “a gain in visual acuity” as recited by claim 1, “a gain in visual acuity” that is “as effective” “as monthly administration of 0.5 mg of ranibizumab” as recited by claim 26, or “maintaining visual acuity” “as effective[ly]” “as monthly administration of 0.5 mg of ranibizumab” as recited by claim 29. See Ex. 1001, 13:5–38 (Table 1). As Patent Owner points out, the ’572 patent’s described studies 1 and 2, when following the claimed dosing regimen (2Q8), were not always effective treatments––achieving mere maintenance (as opposed to improvement or “gains”) of vision 95.1% and 95.6% (respectively) of the time. Id.; see Prelim. Resp. 34–37 (citing Ex. 1001, 13:8–27; Ex. 1014, 4, 6; Ex. 1030, 9; Ex. 2021 ¶¶ 109–111; Ex. 2022). Thus, the evidence shows that, although most would, about 4–5% of patients (or, possibly, an even higher number based on Patent Owner’s cited evidence––Ex. 1030, 9) would not see the gains in visual acuity required by claims 1 and 26 or the maintenance in visual acuity required by claim 29. It is well established that “[i]nherency . . . may not be established by probabilities or possibilities” and “[t]he mere fact that a certain thing may result from a given set of circumstances is not sufficient.” In re. Oelrich, 666 F.2d 578, 581 (CCPA 1981) (quoting Hansgirg v. Kemmer, 102 F.2d 212, 214 (CCPA 1939)). Here, the evidence shows that the claimed results limitations may typically flow from the claimed method, but not necessarily.” slip op. at 33
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“Relating to the claim construction, the Federal Circuit found that patent at issue was “clear” that the tissue fibrosis, recited by the claim as arrested or regressed by the otherwise recited treatment, was not the same as and did not necessarily accompany the symptom of erectile disfunction (taught in and the focus of the relied-upon prior art), although the former (fibrosis) may frequently result in the latter (disfunction). Id. at 1059. The Federal Circuit held that the “arresting or regressing” clause was more than a mere statement of intended result, but was a limitation carrying patentable weight because the phrase was drafted as a part of a separate step of the method rather than of the preamble, the “arresting or regressing” language demanded efficacy, and the efficacy was linked to specific treatment minimum duration and dosage. Id. at 1060–61. The patients exhibiting these two issues were not necessarily the same. In part because the Board did not consider the arresting/regressing result limitation in its unpatentability analysis, the Federal Circuit agreed with the patent owner that the Board’s findings were insufficient. Id. at 1064, 1067. The Federal Circuit found that that prior art reference relied upon in the Board’s decision for teaching the claimed treatment, and also relied upon to link the condition of fibrosis with the symptom of erectile dysfunction, did not teach treating a population of patients suffering from erectile dysfunction only because of a fibrosis condition and, even though such patients may have had fibrosis, it was not certain; and further found that other cited prior art did not make certain a link between fibrosis and such dysfunction. Id. at 1065–66. This, the Federal Circuit found, was error. We find in agreement with Patent Owner that the results limitations of the challenged claims are limitations and must be given patentable weight for the same reasons arresting or regressing a tissue fibrosis was a limitation in Los Angeles Biomed. Similarly, here the claims are directed to expressly required results of the administration of aflibercept to patients at 2 mg at an initial dose, in at least one secondary dose 4 weeks later, and in at least one tertiary dose 8 weeks later. Therefore, we find that in claim 1, “wherein the patient achieves a gain in visual acuity within 52 weeks following the initial dose,” is a limitation. Further, in claim 26, “wherein the method is as effective in achieving a gain in visual acuity as monthly administration of 0.5 mg of ranibizumab by intravitreal injection in human subjects with age-related macular degeneration at 52 weeks following the initial dose,” is a limitation. And, in claim 29, “wherein the method is as effective in maintaining visual acuity as monthly administration of 0.5 mg of ranibizumab by intravitreal injection in human subjects with age-related macular degeneration at 52 weeks following the initial dose,” is a limitation.” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable
“A prior art reference without express reference to a claim limitation may anticipate by inherency. See In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir. 2002). “Under the principles of inherency, if the prior art necessarily functions in accordance with, or includes, the claimed limitations, it anticipates.” Id. (quoting MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999)).” slip op. at 20
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,253,572 - Ricetec, Inc. v. BASF SEAll claims unpatentablePTAB · Mar 8, 2023 · PGR2021-00114 · APJ Tina E Hulse · PGR · Final written decision
Claims 1–17 are unpatentable: they lack written description support and are anticipated by Hinga; the Board also found the challenged dependent claims obvious over the listed combinations.
RulingsFinal written decision- Skill levelSkill level board ownOther
“As explained in our Institution Decision (Dec. Inst. 5–6), we do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner states a POSITA must have one to two years of postdoctoral research experience and Patent Owner’s definition requires at least five years of “research experience,” Patent Owner’s definition does not indicate a specific time for that research (i.e., it could include research during or after a doctoral program). Neither party addresses or contests the other party’s definition in their post-institution papers. See generally PO Resp.; Pet. Reply; PO Sur-reply. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by 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))). Moreover, we find that Dr. Shaner and Dr. Somers are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art, based on either party’s definition. See Ex. 1002 ¶¶ 4–15; Ex. 2036 ¶¶ 5–11, App’x A; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F. 4th 1369, 1376–77 (Fed. Cir. 2022) (“To offer expert testimony from the perspective of a skilled artisan in a patent case—like for claim construction, validity, or infringement—a witness must at least have ordinary skill in the art.”).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner
“amount.” Pet. Reply 14. Patent Owner, however, argues that we erred in our construction because the Specification explicitly defines “effective amount” to mean “the amount of herbicide required to achieve at least about 65% phytotoxicity of conventional [i.e., wild, non-mutant] rice (e.g., red rice) in field applications.” PO Resp. 10 (quoting Ex. 1001, 6:34–37). Because the inventors served as their own lexicographers, Patent Owner asserts the Specification’s express definition controls. Id. at 10–11 (citing Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1380 (Fed. Cir. 2009) (“When a patentee explicitly defines a claim term in the patent specification, the patentee’s definition controls.”)). Nevertheless, Patent Owner acknowledges that the “less than 10% injury” language “is indeed a limitation of the ’346 Patent claims.” Id. at 11. Having considered the arguments and evidence presented at trial, we agree with Patent Owner that the inventors acted as their own lexicographer to define “effective amount” and that that definition governs its meaning. Phillips, 415 F.3d 1316 (“[O]ur cases recognize that the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.”). We, therefore, construe the term “effective amount” to mean “the amount of an herbicide required to achieve at least about 65% phytotoxicity of conventional rice (e.g., red rice) in field applications.” As explained further below, however, whether incorporated into the construction of “effective amount” or not, the claim language itself further requires that the “effective amount” encompass a specific range of amounts of herbicide (i.e., 14 g AI/Ha to 40 g AI/Ha of quizalofop) and cause “less than 10% injury” to the mutant rice. See Ex. 1001, claim 1.” slip op. at 10
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable
“Mankin would derive the herbicide range suggested by Patent Owner and Dr. Somers from the “rules of thumb,” that range is much broader than the claimed range. Claim 1 recites that the effective amount is 14 g AI/Ha–40 g AI/Ha of quizalofop, but, according to Dr. Somers’s calculations from the Assure II herbicide label, a POSITA would understand the effective amount to be 19.25–154 (or 19.25–184.8) g AI/Ha. Ex. 2036 ¶ 54; PO Resp. 38. Patent Owner does not identify anything in the specification that would allow a POSITA to “immediately discern” the specific range limitations of the claims. See General Hospital, 888 F.3d at 1372. As the Federal Circuit has stated, “one cannot disclose a forest in the original application, and then pick a tree out of the forest and say here is my invention.” Purdue Pharma, 230 F.3d at 1326. Thus, we are not persuaded that the disclosure of a broad range of effective amounts via the Assure II herbicide label coupled with Dr. Somers’s undisclosed “rules of thumb” provide written description support for the narrower range limitations of the claims. Moreover, we agree with Petitioner that Patent Owner is impermissibly working backward from the claimed ranges to determine whether Dr. Somers’s “rules of thumb” can be used to re-create the claimed range from the herbicide label. Pet. Reply 15. That is not the test for written description. Written description “requires a statement of an invention, not an invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention.” Indivior UK Ltd. v. Dr. Reddy’s Labs. S.A., 18 F. 4th 1323, 1329 (Fed. Cir. 2021). Accordingly, we are not persuaded that Dr. Somers’s “rules of thumb” applied to the extrinsic herbicide label would be understood by a POSITA as a description in Mankin of the range limitation of the claims. Rather, as Dr. Somers concedes, his “rules of thumb” in conjunction with the herbicide label represent a starting point for a POSITA to test plants to determine what the effective amount range should be. See Ex. 2036 ¶ 53 (referring to a “dose response analysis” between 0.5x and 4x). But “a ‘mere wish or plan’ for obtaining the claimed invention is not sufficient.” See Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1351 (Fed. Cir. 2011).” slip op. at 30
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledNot shown unpatentable
“We are not persuaded. Given the state of the art in 2017, and the known availability of the G2096S seeds at that time, we find the ’346 patent specification enables the claims. The ’346 patent specification clearly describes the G2096S mutant ACCase rice and its use in the claimed method for treating rice. See, e.g., Ex. 1001, 2:37–45, 57:51–61. Contrary to Petitioner’s assertion, the ’346 patent specification has not omitted the G2096S herbicide tolerant rice. Rather, the ’346 patent specification expressly identifies the G2096S mutant rice that possesses the phenotype of tolerance to the effective amounts of herbicides, and describes the method for treating that mutant rice with those effective amounts. See, e.g., id. at 8:8–12; 57:51–61. Thus, we are not persuaded that we erred in relying on Hinga’s seed deposits to determine that Petitioner has failed to meet its burden to prove that the ’346 patent specification fails to enable the challenged claims. Cf. Wands, 858 F.2d at 736 (stating “[n]o deposit is necessary if the biological organisms can be obtained from readily available sources.”).” slip op. at 46
Patent outcomesUS 11,096,346 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 11,096,346 - PTAB · Feb 10, 2023 · IPR2022-01440 · APJ Erica A Franklin · IPR · Institution
The Board instituted IPR on claims 1–19 based on all asserted grounds, finding a reasonable likelihood that the petitioner would prevail on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted unless there is a reasonable likelihood that the petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314(a). 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 1–19 of the ’133 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art (“POSA” or “POSITA”) would have had: a Masters or a Ph.D. degree in nutritional science, chemistry, biology, biochemistry, or a related discipline or an M.D. or doctor of optometry (“O.D.”), and a few years of practical experience in the nutritional supplement area, including an understanding of formulations that could be considered for promoting eye health, including preventing or treating eye disorders such as macular degeneration. Alternatively, such a person could have been a person with a Bachelor’s degree with a greater number of years of experience. The POSITA would have, or would have access to, general information regarding eye health and eye disorders, the convenience and needs of patients who suffer from eye disorders[,] such as macular 5 Lang, WO 01/19383 A1, published Mar. 22, 2001 (Ex. 1009, “Lang”). 6 Brown et al., Nutrition Supplements and the Eye, 12 EYE 127–33 (1998) (Ex. 1014, “Brown”). degeneration, and background information. To the extent needed, the POSITA would have collaborated with others having ordinary skill in the areas pertinent to the subject matter of the ’133 Patent. Pet. 8–9 (citing Ex. 1024 ¶¶ 15–16) (citations omitted). This definition by Petitioner is uncontested on the current record. See Prelim. Resp. 7–8. Because we find Petitioner’s definition to be reasonable and consistent with the ’133 patent and the cited art, we adopt it for purposes of this Decision.” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“1. “substantially free of meso-zeaxanthin stereoisomers” Independent claims 1, 14, and 19 recite that the zeaxanthin is “present in the 3R-3R' stereoisomer form and is substantially free of meso-zeaxanthin stereoisomers.” Claims 1, 14, 19 (emphasis added). Petitioner contend that the term “substantially free of meso-zeaxanthin stereoisomers” should have its plain and ordinary meaning, and a POSA would have understood the term to mean that the zeaxanthin that is present in the 3R-3R' stereoisomer form is “largely but not wholly free of meso-zeaxanthin stereoisomers.” Pet. 25– 26 (emphasis removed) (citing Ex. 1024 ¶ 70; Ex. 1031, 3). The Board adopted, preliminarily, this construction by Petitioner in the Institution Decisions in the -0089 IPR and -1029 IPR. -0089 IPR, Paper 7 at 9–10; -1029 IPR, Paper 6 at 8–9. At this stage of the proceeding, we adopt Petitioner’s proposed construction as consistent with the plain and ordinary meaning of the term and the prior decisions in the -0089 IPR and -1029 IPR.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“We begin by noting that the challenged claims do not recite that the nutritional supplements are “free of Vitamin A” or “free of all sources of Vitamin A.” Rather, independent claim 1 expressly recites that the supplement is “free of beta-carotene.” See Claim 1. Patent Owner urges us to expand the exclusion of beta-carotene to all forms of Vitamin A. That argument, however, lacks support on the current record. In particular, the support asserted by Patent Owner and its expert, Dr. Dorey, that “nutritional supplements include beta-carotene as Vitamin A equivalent,” see Prelim. Resp. 9–10 (citing Ex. 2001 ¶ 19), establishes little, on its own. Barker does not require the use of beta-carotene as its source of Vitamin A, nor does it limit the source or form of Vitamin A used. Rather, Barker discloses that several “[e]xamples of compounds having vitamin Aactivity or precursors thereof are retinol and esters thereof, such as retinyl palmitate; α- and β-carotene, β-cryptoxanthin, and lycopene.” Ex. 1011, 2:11–13. Thus, Barker discloses a number of exemplary compounds to supply Vitamin A to its nutritional supplement that are not beta-carotene. Accordingly, based on the current record, we disagree with Patent Owner’s argument that the challenged claims exclude all forms of Vitamin A and that Barker, therefore fails to anticipate those claims. Having considered the arguments and evidence at this stage in the proceeding, we are persuaded that Petitioner has shown sufficiently for institution that Barker discloses a nutritional supplement that is “free of beta-carotene.” Therefore, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing in showing that claims 1, 2, 5, and 9–12 are anticipated by Barker.” slip op. at 11
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,173,133 - Amphastar Pharmaceuticals, Inc. v. Aegis Therapeutics, LLCSome claims unpatentablePTAB · Feb 9, 2023 · IPR2021-01324 · APJ Cynthia M Hardman · IPR · Final written decision
Claims 1, 2, and 7–17 are unpatentable under §102 or §103; claims 3–6 and 18–20 were not shown unpatentable.
RulingsFinal written decision- Expert testimonyPetitioner expert discountedDecided for patent owner
“in Table 1 and the formulations of Potta claim 21 (i.e., ‘from about 0.1% w/w to about 15% w/w epinephrine or a salt thereof’), because such formulations would elicit the desired biological or medicinal response.” Ex. 1002 ¶ 272. Dr. Weinstein provides an essentially identical opinion. Ex. 1003 ¶ 286. Neither declarant supports their opinion with any explanation as to why the Potta formulations would provide the claimed plasma epinephrine concentration or elicit a biological or medicinal response. Accordingly, we do not credit these opinions, and determine that Petitioner has not met its burden to establish that Potta inherently anticipates claim 3. See n re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”).” slip op. at 29
- ExcludeMotion to exclude, deniedDenied
“As the moving party, Petitioner bears the burden of establishing that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). Having considered the arguments and evidence of record, we determine that Petitioner has not met its burden of proof. We agree with Patent Owner that “[n]o bright line rule prohibits the consideration of post-priority date evidence,” and that such evidence is permissible in certain contexts. Opp. 2–3. On this record we do not find that there is sufficient cause to exclude the challenged exhibits, because any consideration by the Board of these exhibits has taken into account their alleged post-priority date status. Thus, we do not find that maintaining the exhibits in this proceeding results in any unfair prejudice to Petitioner, or that the exhibits have confused the issues before us. Accordingly, we deny Petitioner’s motion to exclude.” slip op. at 73
- Skill levelOther
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“For the above reasons, on the full trial record we determine that” slip op. at 26
Patent outcomesUS 10,682,414 mixed§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,682,414 - PTAB · Feb 8, 2023 · IPR2022-01335 · APJ Arthur M Peslak · IPR · Institution
The Board instituted IPR on claims 19, 20, and 37–52 based on the §103 combination of Hardin and Salmre, finding a reasonable likelihood of prevailing.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“on behalf of the Director.”). Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the Petition shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Considering the Petition, the arguments presented in the Preliminary Response, as well as all supporting evidence, we conclude that the information presented in the Petition establishes that there is a reasonable likelihood that Petitioner would prevail in its challenge of at least one claim of the ’447 patent as unpatentable. Pursuant to 35 U.S.C. § 314, we hereby institute an inter partes review of all Challenged Claims of the ’447 patent on the ground stated in the Petition.” slip op. at 3
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther
“(1) Petitioner asserts that substantially the same two claim limitations lack written description support in the ’094 application and U.S. Patent Application No. 13/856,392 (“the ’392 application”) (compare Pet. 23–29, with IPR2022-01333, Paper 4 (petition) at 23–28); (2) Petitioner asserts that because these limitations lack written description support in the ’094 and ’392 applications, the Challenged Claims are not entitled to the priority date of either of these applications and, therefore, Hardin ’665 (the pre-issuance publication of the ’094 application) is available as prior art to the Challenged Claims (compare Pet. 1, 2, 28–29, with IPR2022-01333, Paper 4 at 1, 2, 28–29);” slip op. at 15
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“(3) Petitioner asserts that the same combination of references— Hardin ’665 and Salmre—would have rendered the subject matter of the claims challenged in each petition obvious to one of ordinary skill in the art at the time of the invention (compare Pet. 29–64, with IPR2022-01333, Paper 4 at 29–66); (4) Petitioner asserts the same reasons with rational underpinning as to why one of ordinary skill in the art would have been motivated to combine the teachings of Hardin ’665 and Salmre as proposed with a reasonable expectation of success (compare Pet. 65–71, with IPR2022-01333, Paper 4 at 66–71);” slip op. at 15
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“that we should exercise our discretion to deny institution pursuant to 35 U.S.C. § 314(a) and Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential) (compare Prelim. Resp. 61–66, with IPR2022-01333, Paper 9 at 61–66);” slip op. at 16
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,984,447 - PTAB · Feb 8, 2023 · IPR2022-01334 · APJ Arthur M Peslak · IPR · Institution
The Board instituted review of claims 18 and 21–36 on the Hardin and Salmre obviousness ground, finding a reasonable likelihood of success.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“on behalf of the Director.”). Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless the information presented in the Petition shows “there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Considering the Petition, the arguments presented in the Preliminary Response, as well as all supporting evidence, we conclude that the information presented in the Petition establishes that there is a reasonable likelihood that Petitioner would prevail in its challenge of at least one claim of the ’447 patent as unpatentable. Pursuant to 35 U.S.C. § 314, we hereby institute an inter partes review of all Challenged Claims of the ’447 patent on the ground stated in the Petition.” slip op. at 3
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“lack written description support in the ’094 application and U.S. Patent Application No. 13/856,392 (“the ’392 application”) (compare Pet. 23–28, with IPR2022-01333, Paper 4 (petition) at 23–28); (2) Petitioner asserts that because these limitations lack written description support in the ’094 and ’392 applications, the Challenged Claims are not entitled to the priority date of either of these applications and, therefore, Hardin ’665 (the pre-issuance publication of the ’094 application) is available as prior art to the Challenged Claims (compare Pet. 1, 2, 28–29, with IPR2022-01333, Paper 4 at 1, 2, 28–29);” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Hardin ’665 and Salmre—would have rendered the subject matter of the claims challenged in each petition obvious to one of ordinary skill in the art at the time of the invention (compare Pet. 29–62, with IPR2022-01333, Paper 4 at 29–66); (4) Petitioner asserts the same reasons with rational underpinning as to why one of ordinary skill in the art would have been motivated to combine the teachings of Hardin ’665 and Salmre as proposed with a reasonable expectation of success (compare Pet. 59–65, with IPR2022-01333, Paper 4 at 66–71);” slip op. at 15
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“that we should exercise our discretion to deny institution pursuant to 35 U.S.C. § 314(a) and Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential) (compare Prelim. Resp. 61–66, with IPR2022-01333, Paper 9 at 61–66);” slip op. at 15
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,984,447 - PTAB · Feb 8, 2023 · IPR2022-01329 · APJ Bart A Gerstenblith · IPR · Institution
The Board instituted IPR on claims 19–28, 33, and 34, finding a reasonable likelihood that Hardin ’665 and Salmre render them obvious.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“An inter partes review may be instituted only if “the information presented in the petition . . . and any [preliminary] response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). For the reasons below, Petitioner has established a reasonable 1 Petitioner’s Preliminary Reply is limited to the issue of discretionary denial pursuant to Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential), and, particularly, the effect of Samsung’s stipulation in related litigation, in accordance with Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A). likelihood that it would prevail in showing the unpatentability of at least one of the Challenged Claims. Accordingly, we institute an inter partes review of the Challenged Claims on all grounds raised in the Petition.” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther
“(1) Petitioner asserts that substantially the same two claim limitations lack written description support in the ’094 application and U.S. Patent Application No. 13/856,392 (“the ’392 application”) (compare Pet. 23–27, with IPR2022-01327, Paper 4 (petition) at 23–27); (2) Petitioner asserts that because these limitations lack written description support in the ’094 and ’392 applications, the Challenged Claims are not entitled to the priority date of either of these applications and, therefore, Hardin ’665 (the pre-issuance publication of the ’094 application) is available as prior art to the Challenged Claims (compare Pet. 1, 2, 27–28, with IPR2022-01327, Paper 4 at 1, 2, 27–28);” slip op. at 15
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“(3) Petitioner asserts that the same combination of references— Hardin ’665 and Salmre—would have rendered the subject matter of the claims challenged in each petition obvious to one of ordinary skill in the art at the time of the invention (compare Pet. 28–62, with IPR2022-01327, Paper 4 at 28–63); (4) Petitioner asserts the same reasons with rational underpinning as to why one of ordinary skill in the art would have been motivated to combine the teachings of Hardin ’665 and Salmre as proposed with a reasonable expectation of success (compare Pet. 62–68, with IPR2022-01327, Paper 4 at 63–69);” slip op. at 16
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“(6) Patent Owner relies on the same argument and evidence to assert that we should exercise our discretion to deny institution pursuant to 35 U.S.C. § 314(a) and Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential) (compare Prelim. Resp. 61–66, with IPR2022-01327, Paper 9 at 61–66);” slip op. at 16
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,049,387
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.