- PTAB · Oct 26, 2022 · IPR2022-00886 · APJ John G New · IPR · Institution
The Board instituted review of claims 1–4 on all petition grounds, finding a reasonable likelihood that Mutz anticipates the claims.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“of claims 1–4 of the ’816 patent. Patent Owner argues, however, that Mutz cannot anticipate claims 1–4 because the reference is not enabled. See Gleave, 560 F.3d at 1334 (holding that, to anticipate, “the reference must “enable one of ordinary skill in the art to make the invention without undue experimentation.” (citing Impax Labs., Inc. v. Aventis Pharms. Inc., 545 F.3d 1312, 1314 (Fed. Cir. 2008))). Specifically, Patent Owner contends that, because Mutz does not disclose a method for making fingolimod HCl, it is not enabled and therefore cannot anticipate the claims of the ’816 patent. We disagree.” slip op. at 25
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“Procedure for Discretionary Denials in AIA Postgrant Proceedings with Parallel District Court Litigation, June 21, 2022 available at: https://www.uspto.gov/sites/default/files/documents/interim_proc_discretion ary_denials_aia_parallel_district_court_litigation_memo_20220621_.pdf (last visited October 11, 222) (the “Guidance”). As stated by the Guidance, the Board will not rely on the Fintiv factors to discretionarily deny institution in view of parallel district court litigation when: (1) a petition presents compelling evidence of unpatentability; (2) a petitioner presents a stipulation (a “Sotera stipulation”) not to pursue in a parallel proceeding the same grounds or any grounds that could have reasonably been raised before the PTAB9; and (3) if all other Fintiv factors weighing against exercising discretion to deny institution, or are neutral, the proximity to trial should not alone outweigh all of those other factors.10 Guidance at 1–8.” slip op. at 40
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“In performing an analysis under § 325(d): [T]he Board uses the following two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.… If, after review of [Becton, Dickinson] factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office, then factors (c), (e), and (f) relate to whether the petitioner has demonstrated a material error by the Office. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential).” slip op. at 45
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“of claims 1–4 of the ’816 patent. Patent Owner argues, however, that Mutz cannot anticipate claims 1–4 because the reference is not enabled. See Gleave, 560 F.3d at 1334 (holding that, to anticipate, “the reference must “enable one of ordinary skill in the art to make the invention without undue experimentation.” (citing Impax Labs., Inc. v. Aventis Pharms. Inc., 545 F.3d 1312, 1314 (Fed. Cir. 2008))). Specifically, Patent Owner contends that, because Mutz does not disclose a method for making fingolimod HCl, it is not enabled and therefore cannot anticipate the claims of the ’816 patent. We disagree.” slip op. at 25
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 9,266,816 - PTAB · Oct 19, 2022 · IPR2022-01513 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 1–8 on all five grounds previously instituted in IPR2022-00517 and granted Teva’s motion to join that proceeding.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Teva’s Petition here is substantively identical to Mylan’s Petition in the -517 IPR, challenging the same claims based on the same art and the same grounds. Compare IPR2022-00517, Paper 1 with IPR2022-01513, Paper 2. For the same 1 European Medicines Agency, Assessment Report, Xarelto, EMA/CHMP/794349/2012 (2013). Ex. 1005 (“EMA”). 2 Foley et al., Antithrombotic therapy in peripheral artery disease, 21 VASCULAR MED. 156–69 (2016). Ex. 1006 (“Foley”). 3 Plosker, Rivaroxaban: A Review of Its Use in Acute Coronary Syndromes, 74 DRUGS 451–64 (2014). Ex 1007 (“Plosker”). reasons stated in our Decision Granting Institution of Inter Partes Review in IPR2022-00517, we institute trial in this proceeding on the same five grounds. See IPR2022-00517, Paper 15.” slip op. at 3
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingJoinder, grantedGranted
“Motion for Joinder. Based on authority delegated to us by the Director, we have discretion to join an inter partes review to a previously instituted inter partes review. 35 U.S.C. § 315(c). Section 315(c) provides, in relevant part, that “[i]f the Director institutes an inter partes review, the Director, in his or her discretion, may join as a party to that inter partes review any person who properly files a petition under section 311.” Id. When determining whether to grant a motion for joinder, we consider factors such as timing and impact of joinder on the trial schedule, cost, discovery, and potential simplification of briefing. Kyocera Corp. v. SoftView, LLC, IPR2013-00004, Paper 15 at 4 (PTAB Apr. 24, 2013).” slip op. at 4
NonePatents in suitUS 10,828,310 - PTAB · Sep 21, 2022 · IPR2022-00684 · APJ James A Tartal · IPR · Institution
The Board instituted IPR on claims 1–18 across all petitioned grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2019). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon consideration of the Petition and the evidence of record, we conclude that the information presented shows a reasonable likelihood that Petitioner would prevail in showing the unpatentability of at least one of the Challenged Claims. Accordingly, we authorize an inter partes review to be instituted as to the Challenged Claims of the ’460 patent on the grounds raised in the Petition. Our factual findings and conclusions at this stage of the proceeding are based on the evidentiary record developed thus far (prior to Patent Owner’s Response). This is not a final decision as to patentability of claims for which inter partes review is instituted. Any final decision will be based on the record, as fully developed during trial.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“have had either “a medical degree and at least two years’ experience with treating glaucoma and performing glaucoma surgery,” or “an undergraduate or graduate degree in biomedical or mechanical engineering and at least five years of work experience in the area of ophthalmology, including familiarity with ophthalmic anatomy and glaucoma surgery.” Pet. 22–23 (citing Ex.1003, ¶ 26). In the absence of any preliminary response, Patent Owner, at this stage of the proceeding, takes no position on the definition of the person of ordinary skill in the art. For purposes of this Decision, at this stage of the proceeding, we accept Petitioner’s proposed definition of the person of ordinary skill in the art, or skilled artisan, which is not opposed by Patent Owner and appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’460 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art)” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for petitioner
“Petitioner suggests, generally, that “all terms should be given their plain and ordinary meaning” and notes that in the related proceedings the Board “gave the term ‘dual blade device’ its ordinary meaning, noting ‘dual refers to two, and blade, in context, refers to a cutting part,” and construed “ab interno” as generally meaning “from the inside or from within the eye.” Pet. 23, 27, 30–31 (citing Ex. 1056, 22–23). We find that an express construction of any claim term is not necessary for purposes of rendering this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)).” slip op. at 10
Claim constructioncites Phillips · KSR · GrahamPatents in suitUS 10,888,460 - Nextremity Solutions, Inc. / Zimmer Biomet Holdings, Inc. et al. v. Extremity Medical, LLCInstitutedPTAB · Aug 16, 2022 · IPR2022-00802 · APJ Jeffrey N Fredman · IPR · Institution
The Board instituted IPR of claim 59 on all three asserted § 102(b) anticipation grounds: Brumfield, Marcus, and Chandran.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“XI. CONCLUSION Petitioner has, at this stage, established a reasonable likelihood of prevailing in showing that at least one of the challenged claims is unpatentable. This determination is, however, based on a preliminary record and is not final on any issues of patentability. We will make a final determination on the patentability of the challenged claims, as necessary and applying the preponderance of the evidence standard, based on a fully developed record through trial. XII. ORDER In consideration of the foregoing, it is hereby: ORDERED that, pursuant to 35 U.S.C. § 314(a) an inter partes review of claim 59 of the ’802 patent is hereby instituted on the grounds set forth in the Petition, commencing on the entry date of this Order, and pursuant to 35 U.S.C. § 314(c) and 37 C.F.R. § 42.4, notice is hereby given of the institution of a trial.” slip op. at 34
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Determining whether claims are anticipated involves a two-step analysis. The first step involves construction of the claims of the patent at issue. Claim construction is a question of law reviewed de novo.” In re Aoyama, 656 F.3d 1293, 1296 (Fed.Cir.2011). “The second step [of an anticipation analysis] involves comparing the claims to the prior art. Anticipation is a question of fact reviewed for substantial evidence.” In re Aoyama, 656 F.3d at 1296. “A prior art reference anticipates a patent claim under 35 U.S.C. § 102(b) if it discloses every claim limitation.” In re Montgomery, 677 F.3d 1375, 1379 (Fed. Cir. 2012). A reference may anticipate inherently if a claim limitation that is not expressly disclosed “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). We analyze the asserted grounds of unpatentability in accordance with these principles to determine whether Petitioner has met its burden to establish a reasonable likelihood of success at trial. slip op. at 10
§ 102 anticipationcites PhillipsPatents in suitUS 8,303,589 - PTAB · Aug 9, 2022 · IPR2022-00517 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 1–8, finding a reasonable likelihood of success on the asserted grounds, including anticipation by EMA.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)InstitutedDecided for petitioner
“The Board has set forth certain factors (“the Fintiv factors”) that may be considered in determining whether to exercise its discretion to deny institution based on the advanced stage of a parallel proceeding: 1. whether the court granted a stay or evidence exists that one may be granted if a proceeding is instituted; 2. proximity of the court’s trial date to the Board’s projected statutory deadline for a final written decision; 3. investment in the parallel proceeding by the court and the parties; 4. overlap between issues raised in the petition and in the parallel proceeding; 5. whether the petitioner and the defendant in the parallel proceeding are the same party; and 6. other circumstances that impact the Board’s exercise of discretion, including the merits. Fintiv, IPR2020-00019, Paper 11, at 5–6. On June 21, 2022, the Director of the Office issued a Memorandum to clarify how the Board should apply certain Fintiv factors when determining whether to exercise its discretion to deny institution under § 314(a).4 The 4 Memorandum Re: Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation (June 21, 2022), available at https://www.uspto.gov/sites/default/files/documents/ interim_proc_discretionary_denials_aia_parallel_district_court_litigation_memo_2 0220621_.pdf. (“Memo”). Memorandum explains that the Board should decline to exercise its discretion to deny institution where: (1) a petition presents compelling evidence of unpatentability; (2) a request for denial under Fintiv is based on a parallel ITC proceeding; or (3) a petitioner stipulates not to pursue in a parallel district court proceeding the same grounds as in the petition or any grounds that could have reasonably been raised in the petition. Memo 2–3. Moreover, when analyzing Fintiv’s second factor, the Board will consider the published median time to trial in the district court in which the parallel litigation resides. Id. at 3. B. Analysis of the Relevant Fintiv Factors As explained further below, we find the Petition presents compelling evidence of unpatentability with respect to the challenges over the EMA reference, which precludes us from exercising our discretion to deny institution under Fintiv. Memo 4–5. Although that factor alone is sufficient to end our analysis, we further note that several other factors support declining to exercise our discretion, as well.” slip op. at 7
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitutedDecided for petitioner
“In performing an analysis under § 325(d), the Board uses a two-part framework: (1) We consider whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) If either condition of the first part of the framework is satisfied, we consider whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019- 01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential).” slip op. at 10
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the argument and evidence presented in the papers, we determine that Petitioner has established 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 1–8 (all claims) of the ’310 Patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“invention would have had “the equivalent of an M.D. degree, knowledge, and experience regarding the diagnosis and treatment of patients with CAD and PAD, including administering antiplatelet and anticoagulant agents to such patients.” Pet. 10 (citing Ex. 1002 ¶¶ 50–52, 89–95). Patent Owner does not contest Petitioner’s definition of the level of ordinary skill in the art for purposes of its Preliminary Response. Prelim. Resp. 10. We adopt Petitioner’s definition as it appears to be consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. 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 13
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,828,310 - PTAB · May 31, 2022 · IPR2022-00403 · APJ Michael A Valek · IPR · Institution
The Board instituted IPR on claims 1–33, finding a reasonable likelihood of success on the Pioneer Hi-Bred anticipation ground and the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“Advanced Bionics9 sets out a two-part framework for analyzing these factors. In the first part, we consider factors (a), (b), and (d) to determine whether the art and arguments presented in the petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, 8–10. “If, after review of factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office,” then we move on to the second part of the analysis to determine “whether the petitioner has demonstrated a material error by the Office” in view of factors (c), (e), and (f). Id.” slip op. at 8
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“On balance, the record before us does not support either party’s view as to the proximity of the district court’s trial date to the projected deadline for our final written decision. Accordingly, this factor is neutral.” slip op. at 16
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Beginning with independent claims 1 and 19, we determine that Petitioner has met its burden for institution. Based on the current record, Petitioner has shown that Table 8 of Pioneer Hi-Bred discloses a synthetic CRISPR crRNA molecule having one or more 2’-O-methyl modifications in its guide sequence (i.e., SEQ ID No: 66 and SEQ ID No: 68). See, e.g., Pet. 26–30. Petitioner also demonstrates sufficiently for institution that Pioneer Hi-Bred discloses a tracrRNA segment complementary to a stem sequence of the crRNA. Id. at 19–25. Petitioner points to Pioneer Hi-Bred’s disclosure that “the modified gRNAs such as those described in [] Tables 7 and 8 can be used to edit cells, e.g., maize cells,” (see id. at 26) thus demonstrating sufficiently for institution that Pioneer Hi-Bred discloses that the modified crRNAs in Table 8 have guide RNA functionality in a CRIPSR-Cas system.” slip op. at 25
- Skill levelSkill level board ownOther
“B. Level of Ordinary Skill in the Art Relying on the testimony of its declarant, Dr. Furneaux, Petitioner contends that a POSA “as of December 3, 2014 (the earliest possible priority date of the ’034 Patent) would have had a Ph.D. in molecular biology, biochemistry, or a related discipline.” Pet. 11 (citing Ex. 1003 ¶ 60). Patent Owner’s declarant, Dr. Marshall, applies the same definition for his analysis. Ex. 2003 ¶ 85. At this stage in the proceeding, we find this description of the level of ordinary skill in the art to be sufficiently supported by the record. Thus, for purposes of this decision, we adopt the description of a POSA noted above.” slip op. at 20
Claim constructionDiscretionary denialcites KSR · GrahamPatents in suitUS 10,900,034 - PTAB · May 31, 2022 · IPR2022-00402 · APJ Michael A Valek · IPR · Institution
The Board instituted IPR on claims 1–30, finding a reasonable likelihood of success on the anticipation challenge and all asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Petitioner has shown that Pioneer Hi-Bred discloses examples of synthetic guide RNA and crRNA molecules having the recited modifications at their 3’ and 5’ ends. See Pet. 20–24 (referring to Table 8 of Ex. 1006). That disclosure undermines the Applicant’s arguments during prosecution that: (1) “a skilled person would not modify a CRISPR guide RNA or crRNA at the particularly claimed positions,” and (2) the reference to “‘securing or steadying the structure’ of RNA in [Zhang] relates to secondary structure” as opposed to “modifications at the claimed positions,” i.e. within five nucleotides from one or both of the ends. Ex. 1002, 783. Both of these arguments were credited by the Examiner as reasons for withdrawing the rejection over Zhang. Id. at 783–784. Thus, Petitioner has sufficiently shown that the Examiner materially erred by not recognizing the relevance of Pioneer Hi-Bred’s disclosure and in particular the crRNA examples in Table 8.” slip op. at 10
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied
“On the current record, we determine that the merits of Petitioner’s anticipation ground appear to be particularly strong for the independent claims and for those dependent claims where Petitioner’s arguments are similarly premised on the crRNA examples in Table 8 being anticipatory without any further modification. See infra § V.E (explaining that, on the current record, Petitioner has shown that Pioneer Hi-Bred Table 8 discloses presumptively-enabled examples that read on claims 1 and 12 as well as a number of the dependent claims). Accordingly, we find that this factor weighs strongly against exercising discretion to deny institution. G. Weighing of Fintiv Factors Considering the Fintiv factors as part of a holistic analysis of the factors discussed above, we are not persuaded that the interests of the efficiency and integrity of the system would be served by invoking our authority under 35 U.S.C. § 314(a) to deny institution of a potentially meritorious Petition. Accordingly, we do not exercise our discretion to deny institution under § 314(a).” slip op. at 18
- Skill levelSkill level board ownOther
“B. Level of Ordinary Skill in the Art Relying on the testimony of its declarant, Dr. Furneaux, Petitioner contends that a POSA “as of December 3, 2014 (the earliest possible priority date of the ’001 Patent) would have had a Ph.D. in molecular biology, biochemistry, or a related discipline.” Pet. 12 (citing Ex. 1003 ¶ 60). Patent Owner’s declarant, Dr. Marshall, applies the same definition for his analysis. Ex. 2003 ¶ 85. At this stage in the proceeding, we find this description of the level of ordinary skill in the art to be sufficiently supported by the record. Thus, for purposes of this decision, we adopt the description of a POSA noted above.” slip op. at 19
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction Neither party identifies any claim term for construction. Pet. 17; Prelim. Resp. 35. We agree that no formal claim construction is necessary at this stage of the proceeding. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that it is only necessary to “construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 21
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,337,001 - PTAB · May 18, 2022 · IPR2022-00142 · APJ John G New · IPR · Institution
The Board instituted IPR of claims 1–6 on all petitioned grounds, finding a reasonable likelihood that claim 1 is anticipated by Gil and claims 1–6 are obvious over the cited combination.
RulingsInstitution decision- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“When ‘about’ is used as part of a numeric range, the use of the word “‘about’” avoids a strict numerical boundary to the specified parameter.” Cohesive, 543 F.3d at 1368 (internal quotations omitted). When “about” is used to define the limit of a numerical range, the extension beyond the stated number depends on what “a person having ordinary skill in the art … would reasonably consider ‘about …’ to encompass.” Monsanto Tech. LLC v. E.I. DuPont de Nemours & Co., 878 F.3d 1336, 1342 (Fed. Cir. 2018). Furthermore, when determining how far beyond the claimed range the term “about” extends the claim, “[w]e must focus ... on the criticality of the [numerical limitation] to the invention.” Ortho–McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1327 (Fed. Cir. 2007). “Extrinsic evidence of meaning and usage in the art may be helpful in determining the criticality of the parameter.” Id. at 1326 (quoting Pall Corp. v. Micron Separations, Inc., 66, F.3d 1211, 1217 (Fed. Cir. 1995)). At this stage of the proceeding, and on this record, we find Petitioner’s reasoning that the claim term “about 0.025%” includes 0.03% to be more persuasive. As Petitioner points out, the Specification discloses a number of embodiments with concentration ranges of brimonidine that include both values. Furthermore, Patent Owner has not persuasively pointed to any disclosures of the ’742 patent that expressly support the criticality of 0.025% brimonidine as the upper end of the concentration range. Indeed, the passage pointed to in this respect by Patent Owner states: FIG. 6 depicts a graphical representation of a finding of the present invention that an increased rebound hyperemia begins at around 0.03% for brimonidine. It thus demonstrates that the net effectiveness of brimonidine as a decongestant is greatest between about 0.01% and about 0.03%; preferably, between about 0.012% and about 0.02%. Ex. 1001, col. 19, ll. 52–57. This passage does not expressly or implicitly disclose the criticality of “about 0.025%” as the upper limit of the effective range of brimonidine concentration. slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“2. “ocular condition” Petitioner argues that the ’742 patent defines “ocular condition” broadly and without limitation. Pet. 31 (citing Ex. 1001, col. 12, ll. 14–49). Petitioner therefore urges us to construe “ocular condition” as including, without limitation eye redness, glaucoma (including open-angle glaucoma); elevated intraocular pressure, also known as ocular hypertension, postoperative reduction of subconjunctival hemorrhage and hyperemia after refractive surgery such as LASIK and radial keratotomy, subconjunctival hemorrhage and hyperemia prophylaxis prior to refractive surgery such as LASIK and radial keratotomy, and redness in the eye following LASIK or radial keratotomy. Id. (citing Ex. 1001, col. 12, ll. 14–49; Ex. 1002 ¶ 47). Patent Owner makes no argument with respect to construction of this claim term, other than to note that the phrase would be understood by a skilled artisan to have its ordinary meaning consistent with the Specification. Given the capacious disclosures of the Specification of the ’742 patent in this respect, we find Petitioner’s proposed construction to be reasonable. See Ex. 1001, col. 12, ll. 14–52. We consequently construe, for the purposes of this Decision, the claim term “ocular condition” as including, without limitation, “eye redness, glaucoma (including open-angle glaucoma); elevated intraocular pressure, also known as ocular hypertension, postoperative reduction of subconjunctival hemorrhage and hyperemia after refractive surgery such as LASIK and radial keratotomy, subconjunctival hemorrhage and hyperemia prophylaxis prior to refractive surgery such as LASIK and radial keratotomy, and redness in the eye following LASIK or radial keratotomy.” 3. Additional claim construction Reviewing the present record, the panel the panel concludes that no other claim term needs express construction for the purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (per curiam) (claim terms need to be construed “only to the extent necessary to resolve the controversy” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 12
- Skill levelSkill level petitioner adoptedDecided for petitioner
“have been a composite person (or team) that included a medical doctor and a pharmaceutical formulator. Pet. 15 (citing Ex. 1002 ¶ 26; Ex. 1003 ¶ 29). Petitioner asserts that the medical doctor would have been an ophthalmologist with at least three to four years of experience in LASIK surgery, clinical trials, and U.S. FDA regulation of eye products, and had experience in the use of topical brimonidine, apraclonidine; and topical vasoconstrictors such as naphazoline and tetrahydrozoline. Id. (citing Ex. 1002 ¶ 26). Petitioner contends that the pharmaceutical formulator would have had a doctoral degree in pharmaceutics, or a related degree, and at least three to five years of experience developing eye drop formulations for clinical trial and regulatory approval. Id. (citing Ex. 1003 ¶ 29). Patent Owner does not contest this definition in its Preliminary Response, stating it does not take a position at this time regarding the qualifications of the person of ordinary skill in the art. Prelim. Resp. 29. Patent Owner further notes that Petitioner’s characterization of a person of ordinary skill in the art goes beyond that of ordinary skill. Id. We find Petitioner’s proposed characterization to be reasonable and consequently adopt Petitioner’s definition for the purposes of this Decision.” slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundInstituted
“A claim is unpatentable under 35 U.S.C. § 102 only when “every element and limitation of the claim was previously described in a single prior art reference, either expressly or inherently, so as to place a person of ordinary skill in possession of the invention.” Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1082 (Fed. Cir. 2008). With respect to Petitioner’s argument that Gil inherently discloses the preambular limitation reciting a “method for reducing eye redness,” we agree that, although Gil teaches that “[o]cular responses characteristic of neurogenic inflammation, including redness and pupillary constriction, are also observed in rabbits following external stimuli,” Example 1 of Gil does not expressly teach that administration of 0.03% brimonidine reduces redness in the subject patients. See Ex. 1004, col. 5, ll. 38–40. Nevertheless, we do not agree with Patent Owner that Gil teaches only the reduction of ocular pain via administration of brimonidine in the claimed concentrations. Gil discloses that a person of skill in the art would understand that inflammation of the eye is accompanied by both redness and pain, and expressly discloses that its invention is directed to “the topical application of brimonidine for treating ocular pain and neurogenic inflammation.” Id. at col. 1, ll. 11–13. Gil also discloses that “neuropeptides enhance inflammatory reactions in the injured tissue, contributing to vasodilation, edema, and increased vascular permeability, this phenomenon is called ‘neurogenic inflammation.’” Id. at col. 1, ll. 40– 43. We find that a skilled artisan would understand that “neurogenic inflammation,” and particularly “vasodilation, edema, and increased vascular permeability” are proximal causes of eye redness. See id. at col. 5, ll. 38–40. Furthermore, and as Petitioner argues, the ’742 Specification also expressly teaches that administration of doses of brimonidine of 0.02– 0.033% resulted in redness reduction. See Ex. 1001, cols. 19–20, ll. 65–25. Although Gil is generally silent with respect to redness reduction, using pain as an indicator of neurogenic inflammation, the ’742 Specification demonstrates that application of 0.03% brimonidine would also necessarily reduce redness when administered to patients with an ocular condition. See also Ex. 1025. We therefore conclude that Petitioner has established a reasonable likelihood of success in prevailing at trial with respect to at least one claim upon Ground 1.” slip op. at 19
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 8,293,742 - Restem, LLC. v. Jadi Cell, LLCInstitutedPTAB · Apr 20, 2022 · IPR2021-01535 · APJ Devon Zastrow Newman · IPR · Institution
The Board instituted IPR on claims 1–15 over all asserted grounds, finding a reasonable likelihood that Petitioner would show at least one challenged claim unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority to determine whether to institute an inter partes review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2019). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon consideration of the Petition, the Preliminary Response, and the evidence of record, we conclude that the information presented shows a reasonable likelihood that Petitioner would prevail in showing the unpatentability of at least one of the Challenged Claims. Accordingly, we authorize an inter partes review to be instituted as to the Challenged Claims of the ’176 patent on the grounds raised in the Petition. Our factual findings and conclusions at this stage of the proceeding are based on the evidentiary record developed thus far (prior to Patent Owner’s Response). This is not a final decision as to patentability of claims for which inter partes review is instituted. Any final decision will be based on the record, as fully developed during trial.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Pet. 15 (citing Ex. 1007 ¶¶ 19–24). Patent Owner does not comment on the characterization offered by Petitioner or offer one of its own. See generally Prelim. Resp. For purposes of this Decision, we adopt Petitioner’s characterization as it is consistent with the level of skill in the art at the time of the invention as reflected by the ’176 patent and the cited prior art. 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 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionOther
“Prelim. Resp. 16. Patent Owner cites Ex. 1001 6:32–34, noting that the patent specification “expressly defines ‘isolated cell’ as ‘[referring] to a cell that has been isolated from the subepithelial layer of a mammalian umbilical cord.’” Id. As neither party references any prosecution history related to interpretation of this claim term, we look only to the claim itself and the specification as intrinsic evidence. DePuy Spine, 469 F.3d at 1014. Claim 1 recites “an isolated cell prepared by a process comprising . . . ” Ex. 1001 at 19:6. As Patent Owner notes, the patent specification states “the term ‘isolated cell’ refers to a cell that has been isolated from the subepithelial layer of a mammalian umbilical cord.” Id. at 6:32–34. The remainder of the citations Petitioner cites relate to additional steps for isolating the cell, or characteristics of the cell, such as the markers expressed or not expressed, but do not further elucidate the meaning of “an isolated cell” itself. Dr. Olsen’s testimony reiterates the content of these citations but does not add any additional information or explanation. Ex. 1007 ¶¶ 67–68. Given the definition provided in the specification, we interpret “an isolated cell,” consistent with Patent Owner’s definition, to mean “one or more cells isolated from the subepithelial layer of a mammalian umbilical cord.”” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInstituted
“the Wharton’s Jelly, epithelium, etc.” and that, without evidence that the recited markers are expressed/not expressed as recited, there is no inherent disclosure. Prelim. Resp. 22, 25, 28–29 (citing Ex. 2022 ¶ 162). Patent Owner is correct that an ultimate finding of anticipation requires such confirmation, but, for purposes of institution, our standard is a reasonable likelihood. 35 U.S.C. § 314(a). Due to the breadth of claim 1, Majore’s method must produce only one cell having the recited limitations to anticipate. Petitioner’s expert testifies that production of such cells would be inherent by Majore. See Ex. 1007 ¶ 97 (“Majore’s protocol would produce a population of adherent cells that necessarily and inevitably comprise the cells of the subepithelial layer.”). And, although we recognize that the burden of persuasion does not rest on Patent Owner, Dr. Burger’s testimony, which focuses heavily on the differences in methodology between Majore and the ’176 patent disclosure and Petitioner’s alleged failure of proof, is not persuasive at this stage to overcome the evidence presented by Petitioner. See Ex. 2002 ¶¶ 137–163. Indeed, both Majore and the ’176 patent disclose umbilical cord tissue cut into sections and placed into environments fostering cell culture and replication. Ex. 1011 at 18, Ex. 1001 at 13:57–14:5. Both methods encourage and result in adherent cells growing on a plastic growth surface awash in culture media. Id. On this record, Petitioner has provided sufficient factual basis to establish a reasonable likelihood that Majore’s explant method of dissecting umbilical cord, culturing cells, and growing adherent cells would have produced (or did produce) at least one cell with the recited limitations. In this regard, we credit the testimony of Dr. Olsen that the isolated cells disclosed in Majore are MSCs cultured from umbilical cord tissues including the subepithelial layer, which have migrated to the periphery of the cut tissue and adhered to the tissue culture vessel. Ex. 1007 ¶¶ 95–97. That Majore discloses genetic markers with similar expression/non-expression to the markers recited in claim 1 is further evidence that at least some cells were cultured from the subepithelial layer. Id. ¶ 99. Moreover, even if we gave weight to the process limitations construed as requested by Patent Owner (Prelim. Resp. 13–20), the limitations are sufficiently broad as to read on Majore with the exception of the express/non-expressed markers. With regard to markers not examined by Majore, we credit Dr. Olson’s statement that “the cells obtained by Majore’s protocol necessarily and inevitably comprise the same cells produced by the process steps of claim 1[A] and 1[B]” and that the skilled artisan would have understood that the marker expression pattern would be identical for those cells. Id. ¶ 101.16 The evidence on this issue is subject to final determination on a more complete record developed through trial.” slip op. at 21
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,803,176 - PTAB · Apr 18, 2022 · IPR2022-00089 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 12–14, 16–21, 23, and 24 based on the petition’s anticipation and obviousness grounds.
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 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the argument and evidence presented in the papers, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of the claim challenged in the Petition. Accordingly, we institute an inter partes review of claims 12–14, 16–21, 23, and 24 of the ’384 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“A. Person of Ordinary Skill in the Art Petitioner asserts that a person of ordinary skill in the art at the time of the invention 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 degeneration, and background information. And to the extent needed, the POSITA would have collaborated with others having ordinary skill in the areas pertinent to the subject matter of the ’384 Patent. Pet. 7–8 (citing Ex. 1024 ¶ 16). Patent Owner states that “[f]or purposes of this Preliminary Response, Patent Owner does not contest [Petitioner’s] definition.” Prelim. Resp. 11. We adopt Petitioner’s definition as it appears to be consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. 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 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for petitioner
“On this record, we find the preamble to be limiting. “In general, a preamble limits the invention if it recites essential structure or steps, or if it is necessary to give life, meaning, and vitality to the claim.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quotation omitted). On the other hand, a preamble is not limiting “where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.” Id. Although not dispositive, “dependence on a particular disputed preamble phrase for antecedent basis may limit claim scope because it indicates a reliance on both the preamble and claim body to define the claimed invention.” See Shoes by Firebug LLC v. Stride Rite Children’s Group, LLC, 962 F.3d 1362, 1367 (Fed. Cir. 2020) (citation omitted). Here, the preamble of claim 12 recites: “A nutrient formulation for oral ingestion for protecting a user’s eyes from the harmful effect of blue light, the formulation comprising:.” Ex. 1001, 37:13–15. The body of claim 12 recites “wherein the nutrient formulation is provided in the form selected from the group consisting of capsules, tablets, liquids, and powders for oral ingestion.” Ex. 1001, 37:22–24 (emphasis added). Because the first use of “nutrient formulation” is in the preamble, claim 12 relies on the preamble for antecedent basis for “the nutrient formulation.” Id. (emphasis added). Similarly, claim 22, which depends from claim 12, relies on the preamble of” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“2. Remaining Claim Terms Petitioner contends the term “substantially-free of meso-zeaxanthin stereoisomers” should have its plain and ordinary meaning, and a person of zeaxanthin that is present in the 3R-3R' stereoisomer form is “largely but not wholly free of meso-zeaxanthin stereoisomers.” Pet. 19 (citing Ex. 1024 ¶ 57, Ex. 1031, 3). Patent Owner does not offer a construction for this term. See generally Prelim. Resp. Petitioner also contends the term “mixed tocopherols” should be construed to mean “a mixture of tocopherols such as alpha-, beta-, gamma-, and delta-tocopherols.” Pet. 22–24 (citing Ex. 1024 ¶¶ 65–66). Patent Owner does not offer a construction for this term. See generally Prelim. Resp. Because there does not appear to be any dispute over the construction of these terms, we adopt Petitioner’s proposed constructions as consistent with the plain and ordinary meaning of the terms. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 9
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,307,384
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.