- Novartis Pharmaceuticals Corporation v. Shilpa Pharma, Inc.All claims unpatentablePTAB · Sep 29, 2023 · IPR2022-00886 · APJ John G New · IPR · Final written decision
Claims 1–4 are unpatentable under §102 over Mutz; the Board did not reach the §103 Mutz and Gidwani or §102 Gidwani grounds.
In the decision…Having obtained fingolimod hydrochloride by one of these methods or otherwise, a scientist could then determine its form using XRPD. Given Mutz’s teaching that fingolimod hydrochloride “exists in a particular crystalline form [Form I] at room temperature”… it would very likely be Form I already.…
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“§ 6. This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons set forth below, we determine that Petitioner Novartis Pharmaceuticals Corporation (“Petitioner”) has established, by a preponderance of the evidence of record, that challenged claims 1–4 of Patent Owner Shilpa Pharma Inc.’s (“Patent Owner”) U.S. Patent No. 9,266,816 B2 (Ex. 1001, the “’816 patent”) are unpatentable. Additionally, because we find that Petitioner has established that claims 1–4 are unpatentable, we dismiss as moot Petitioner’s Motion to Exclude Evidence (Paper 59). Furthermore, for the reasons we set forth below, Patent Owner’s Motion to Exclude Evidence (Paper 48) is dismissed-in-part as moot and denied-in-part. Both parties’ unopposed Motions to Seal are granted. See Papers 31, 33, 39, 40, 42, 46, 52, 56, 57, 60, 62, 68. Finally we deny Petitioner’s Motion for Sanctions against Patent Owner. (Paper 43).” slip op. at 2
- ExcludeMotion to exclude, grantedMixed
“§ 6. This Final Written Decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. For the reasons set forth below, we determine that Petitioner Novartis Pharmaceuticals Corporation (“Petitioner”) has established, by a preponderance of the evidence of record, that challenged claims 1–4 of Patent Owner Shilpa Pharma Inc.’s (“Patent Owner”) U.S. Patent No. 9,266,816 B2 (Ex. 1001, the “’816 patent”) are unpatentable. Additionally, because we find that Petitioner has established that claims 1–4 are unpatentable, we dismiss as moot Petitioner’s Motion to Exclude Evidence (Paper 59). Furthermore, for the reasons we set forth below, Patent Owner’s Motion to Exclude Evidence (Paper 48) is dismissed-in-part as moot and denied-in-part. Both parties’ unopposed Motions to Seal are granted. See Papers 31, 33, 39, 40, 42, 46, 52, 56, 57, 60, 62, 68. Finally we deny Petitioner’s Motion for Sanctions against Patent Owner. (Paper 43).” slip op. at 2
- PTAB / AIA Trials › Other PTAB motions (exclude, strike, seal, additional discovery, rehearing)Denied
“claims, Petitioner’s request that we do so as a sanction against Patent Owner is denied. Furthermore, having reviewed the arguments and evidence presented by Petitioner and Patent Owner, we conclude that the evidence is not sufficiently conclusive to warrant the additional imposition of financial sanctions. We consequently deny Petitioner’ Motion for Sanctions.” slip op. at 82
Patent outcomesUS 9,266,816 unpatentable§ 102 anticipationcites PhillipsPatents in suitUS 9,266,816 - PTAB · Sep 22, 2023 · IPR2023-00481 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 17, 19, 20, and 22–27 because Hopewell showed a reasonable likelihood that the claims would have been obvious over Bodor and Stelmasiak.
In the decision…1, 17–18 (1966). Moreover, “[a]n obviousness determination requires finding both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of…
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“5. Analysis: Claim 17 Based on the present record, Petitioner persuades us that it is reasonably likely to prevail in establishing that claim 17 would have been obvious over Bodor and Stelmasiak. We agree with Petitioner’s showing that Bodor teaches or suggests a method for treating MS, including RRMS, by orally administering cladribine tablets over a two-month induction period at a total dose of between 100 mg to 140 mg (equivalent to 1.4–2.0 mg/kg for the average patient) and, thus, satisfies claim 17’s preamble15 and step (i). See, e.g., Pet. 46–51. Bodor also expressly teaches such an” slip op. at 32
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“Because we agree that Bodor and Stelmasiak were presented previously to the Office, we turn to part two of the Advanced Bionics framework—whether there was a material error by the Office.” slip op. at 54
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Analogous artInstituted
“reasonably likely to prevail in establishing that claim 17 would have been obvious over Bodor and Stelmasiak. We agree with Petitioner’s showing that Bodor teaches or suggests a method for treating MS, including RRMS, by orally administering cladribine tablets over a two-month induction period at a total dose of between 100 mg to 140 mg (equivalent to 1.4–2.0 mg/kg for the average patient) and, thus, satisfies claim 17’s preamble15 and step (i). See, e.g., Pet. 46–51. Bodor also expressly teaches such an” slip op. at 32
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“maintenance period” or a secondary cladribine-free period, we find it logical, credible, and consistent with Dr. Miller’s testimony, that a POSA would have understood Bodor to suggest retreatment and that a POSA would know that retreatment is often needed given the chronic, incurable nature of MS. See, e.g., Ex. 1002 ¶¶ 86–87, 100–102 (testifying that a POSA would have thought to readminister cladribine according to Bodor’s initial treatment regimen, disclosed as suitable for MS treatment, and optimize if needed). Moreover, Petitioner provides evidence-backed reasoning supporting why it would have been routine and obvious to “tailor” the dosage, including by starting with a lower dose and “step-wise” increase it until a desired therapeutic effect is achieved. See, e.g., Ex. 1022, 24:1–9;16 Ex. 1002 ¶ 93. The POSA would have also been aware, from at least Stelmasiak, that it’s possible to give lower amounts of cladribine in a maintenance phase versus an induction phase, keeping lymphocyte counts in a suppressed state, and providing therapeutic benefits even over extended periods where no cladribine is administered. Ex. 1013, 5–7 (describing a decrease in relapse rate and EDSS improvements over a twenty-four month study period). That, combined with Bodor’s teachings and an expectation that a lower dose and intermittent cladribine-free periods would help manage 16 See also Ex. 1022, 26:2–8 (teaching that dosages are given with concomitant, continuous clinical evaluations by a skilled practitioner to “determine subsequent therapy” and “evaluating whether to increase, reduce or continue a particular treatment dose”). ¶¶ 50–52, 91, 95, 103. Based on Petitioner’s evidence and reasoning, we find it reasonably likely that a POSA would have found it obvious to modify Bodor’s method to arrive at steps (iii) and (iv) of claim 17. We also find that the preliminary record, on balance, supports Petitioner’s contention that the POSA would have reasonably expected success in modifying the art to arrive at the subject matter of claim 17. Bodor discloses a method for treating MS with administration of oral cladribine and provides further guidance for adjusting the dosage or duration as needed to produce a desired therapeutic result. See, e.g., Ex. 1022, 22:18–22, 23:15–20, 24:1–9. Stelmasiak further evidences efficacy in treating RRMS with cladribine administration, including in oral and parenteral forms. Ex. 1013, 7. And neither Bodor nor Stelmasiak stands alone; as pointed out by Petitioner and Dr. Miller, several studies predating the ’903 patent describe the use of cladribine for treating MS, including RRMS, and such studies inform the POSA’s background knowledge—a necessary consideration in any obviousness analysis. See Pet. 19–21, 44; Ex. 1002 ¶¶ 35–49, 115; Randall Mfg. v. Rea, 733 F.3d 1355, 1362 (Fed. Cir. 2013) (“[T]he knowledge of such an artisan is part of the store of public knowledge that must be consulted when considering whether a claimed invention would have been obvious.”). Indeed, many of these studies are incorporated by reference into Bodor. Ex. 1022, 22:27–23:6 (incorporating, e.g., Romine (Ex. 1031) and Rice (Ex. 1018), after teaching that “various dosage amounts and dosing regimens have been reported in the literature for use in the treatment of multiple sclerosis”). slip op. at 33
§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 8,377,903 - PTAB · Sep 22, 2023 · IPR2023-00480 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 36, 38, 39, and 41–46, finding a reasonable likelihood that at least one claim would have been obvious over Bodor and Stelmasiak.
In the decision…1, 17–18 (1966). Moreover, “[a]n obviousness determination requires finding both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of…
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“5. Analysis: Claim 36 Based on the present record, Petitioner persuades us that it is reasonably likely to prevail in establishing that claim 36 would have been obvious over Bodor and Stelmasiak. We agree with Petitioner’s showing that Bodor teaches a method for treating MS by orally administering cladribine tablets over a two-month induction period at a total dose of between 100 mg to 140 mg (equivalent to 1.4–2.0 mg/kg for the average patient) and, thus, satisfies claim 36’s preamble14 and step (i). See, e.g., Pet. 45–49. Bodor also expressly teaches such an induction period is followed by a ten-month cladribine-free period—meeting claim 36’s step (ii) (reciting a cladribine-free period of between about 8–10 months), as argued by Petitioner. Id. at 49–50; Ex. 1022, 23:15–20. Although Bodor does not explicitly describe a subsequent “maintenance period” or a secondary cladribine-free period, we find it logical, credible, and consistent with Dr. Miller’s testimony, that a POSA would have understood Bodor to suggest retreatment and that a POSA would know that retreatment is often needed given the chronic, incurable nature of MS. See, e.g., Ex. 1002 ¶¶ 86–87, 100–102 (testifying that a POSA would have thought to readminister cladribine according to Bodor’s initial treatment regimen, disclosed as suitable for MS treatment, and optimize if 13 This paragraph is a high-level summary of Patent Owner’s argument (Prelim. Resp. 1–3, 51); we discuss Patent Owner’s argument in more detail in our analysis below but summarize here to reduce repetition. 14 We need not determine whether the preamble is limiting because, at this stage, there is no dispute that it is taught or suggested in the asserted art. supporting why it would have been routine and obvious to “tailor” the dosage, including by starting with a lower dose and “step-wise” increase it until a desired therapeutic effect is achieved. See, e.g., Ex. 1022, 24:1–9;15 Ex. 1002 ¶ 93. The POSA would have also been aware, from at least Stelmasiak, that it’s possible to give lower amounts of cladribine in a maintenance phase versus an induction phase, keeping lymphocyte counts in a suppressed state, and providing therapeutic benefits even over extended periods where no cladribine is administered. Ex. 1013, 5–7 (describing a decrease in relapse rate and EDSS improvements over a twenty-four month study period). That, combined with Bodor’s teachings and an expectation that a lower dose and intermittent cladribine-free periods would help manage potential side effects, supports Petitioner’s challenge. See, e.g., Ex. 1002 ¶¶ 50–52, 91, 95, 103. Based on Petitioner’s evidence and reasoning, we find it reasonably likely that a POSA would have found it obvious to modify Bodor’s method to arrive at steps (iii) and (iv) of claim 36. We also find that the preliminary record, on balance, supports Petitioner’s contention that the POSA would have reasonably expected success in modifying the art to arrive at the subject matter of claim 36. Bodor discloses a method for treating MS with administration of oral cladribine and provides further guidance for adjusting the dosage or duration as needed to produce a desired therapeutic result. See, e.g., Ex. 1022, 22:18–22, 23:15–20, 24:1–9. Stelmasiak further evidences efficacy in 15 See also Ex. 1022, 26:2–8 (teaching that dosages are given with concomitant, continuous clinical evaluations by a skilled practitioner to “determine subsequent therapy” and “evaluating whether to increase, reduce or continue a particular treatment dose”). forms. Ex. 1013, 7. And neither Bodor nor Stelmasiak stands alone; as pointed out by Petitioner and Dr. Miller, several studies predating the ’947 patent describe the use of cladribine for treating MS, and such studies inform the POSA’s background knowledge—a necessary consideration in any obviousness analysis. See Pet. 19–21, 44; Ex. 1002 ¶¶ 35–49, 115; Randall Mfg. v. Rea, 733 F.3d 1355, 1362 (Fed. Cir. 2013) (“[T]he knowledge of such an artisan is part of the store of public knowledge that must be consulted when considering whether a claimed invention would have been obvious.”). Indeed, many of these studies are incorporated by reference into Bodor. Ex. 1022, 22:27–23:6 (incorporating, e.g., Romine (Ex. 1031) and Rice (Ex. 1018), after teaching that “various dosage amounts and dosing regimens have been reported in the literature for use in the treatment of multiple sclerosis”).” slip op. at 32
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“interpreted to resolve Petitioner’s challenge. Patent Owner’s interpretation is broader and encompasses Petitioner’s interpretation. Nevertheless, to address the arguments made and give guidance for trial, we determine that the weight of the evidence on this preliminary record supports Patent Owner’s interpretation, and we conclude that the dosing of cladribine given during the “maintenance period” can be same as or lower than the total dose given during the induction period. We explain below. First, the language of the claims supports Patent Owner’s interpretation. Claim 36 expressly recites that the total dose reached at the end of the induction period (step (i)) “is from about 1.7 mg/kg to about 3.5 mg/kg.” See supra Section II(D). Claim 36, step (iii), recites that the total dose of cladribine reached at the end of the maintenance period “is about 1.7 mg/kg.” The plain language of claim 36, thus, indicates that the cladribine dosing given during the induction period and the maintenance period can be the same—each “about 1.7 mg/kg.” Claim 36 also encompasses regimens where the maintenance period dosing (e.g., 1.7 mg/kg) is lower compared to the induction period dosing (e.g., 3.5 mg/kg). But the plain language of the claims does not require a lower total dose in the maintenance period. Petitioner’s construction narrows the claims and, in effect, asks us to rewrite the lower bound of the range recited in claim 36’s induction period step to be some value higher than “about 1.7 mg/kg.” We decline to do so.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“reasonably likely to prevail in establishing that claim 36 would have been obvious over Bodor and Stelmasiak. We agree with Petitioner’s showing that Bodor teaches a method for treating MS by orally administering cladribine tablets over a two-month induction period at a total dose of between 100 mg to 140 mg (equivalent to 1.4–2.0 mg/kg for the average patient) and, thus, satisfies claim 36’s preamble14 and step (i). See, e.g., Pet. 45–49. Bodor also expressly teaches such an induction period is followed by a ten-month cladribine-free period—meeting claim 36’s step (ii) (reciting a cladribine-free period of between about 8–10 months), as argued by Petitioner. Id. at 49–50; Ex. 1022, 23:15–20. Although Bodor does not explicitly describe a subsequent “maintenance period” or a secondary cladribine-free period, we find it logical, credible, and consistent with Dr. Miller’s testimony, that a POSA would have understood Bodor to suggest retreatment and that a POSA would know that retreatment is often needed given the chronic, incurable nature of MS. See, e.g., Ex. 1002 ¶¶ 86–87, 100–102 (testifying that a POSA would have thought to readminister cladribine according to Bodor’s initial treatment regimen, disclosed as suitable for MS treatment, and optimize if 13 This paragraph is a high-level summary of Patent Owner’s argument (Prelim. Resp. 1–3, 51); we discuss Patent Owner’s argument in more detail in our analysis below but summarize here to reduce repetition. 14 We need not determine whether the preamble is limiting because, at this stage, there is no dispute that it is taught or suggested in the asserted art. supporting why it would have been routine and obvious to “tailor” the dosage, including by starting with a lower dose and “step-wise” increase it until a desired therapeutic effect is achieved. See, e.g., Ex. 1022, 24:1–9;15 Ex. 1002 ¶ 93. The POSA would have also been aware, from at least Stelmasiak, that it’s possible to give lower amounts of cladribine in a maintenance phase versus an induction phase, keeping lymphocyte counts in a suppressed state, and providing therapeutic benefits even over extended periods where no cladribine is administered. Ex. 1013, 5–7 (describing a decrease in relapse rate and EDSS improvements over a twenty-four month study period). That, combined with Bodor’s teachings and an expectation that a lower dose and intermittent cladribine-free periods would help manage potential side effects, supports Petitioner’s challenge. See, e.g., Ex. 1002 ¶¶ 50–52, 91, 95, 103. Based on Petitioner’s evidence and reasoning, we find it reasonably likely that a POSA would have found it obvious to modify Bodor’s method to arrive at steps (iii) and (iv) of claim 36. We also find that the preliminary record, on balance, supports Petitioner’s contention that the POSA would have reasonably expected success in modifying the art to arrive at the subject matter of claim 36. Bodor discloses a method for treating MS with administration of oral cladribine and provides further guidance for adjusting the dosage or duration as needed to produce a desired therapeutic result. See, e.g., Ex. 1022, 22:18–22, 23:15–20, 24:1–9. Stelmasiak further evidences efficacy in 15 See also Ex. 1022, 26:2–8 (teaching that dosages are given with concomitant, continuous clinical evaluations by a skilled practitioner to “determine subsequent therapy” and “evaluating whether to increase, reduce or continue a particular treatment dose”). forms. Ex. 1013, 7. And neither Bodor nor Stelmasiak stands alone; as pointed out by Petitioner and Dr. Miller, several studies predating the ’947 patent describe the use of cladribine for treating MS, and such studies inform the POSA’s background knowledge—a necessary consideration in any obviousness analysis. See Pet. 19–21, 44; Ex. 1002 ¶¶ 35–49, 115; Randall Mfg. v. Rea, 733 F.3d 1355, 1362 (Fed. Cir. 2013) (“[T]he knowledge of such an artisan is part of the store of public knowledge that must be consulted when considering whether a claimed invention would have been obvious.”). Indeed, many of these studies are incorporated by reference into Bodor. Ex. 1022, 22:27–23:6 (incorporating, e.g., Romine (Ex. 1031) and Rice (Ex. 1018), after teaching that “various dosage amounts and dosing regimens have been reported in the literature for use in the treatment of multiple sclerosis”).” slip op. at 32
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“weight-based dosing. Prelim. Resp. 29–30. According to Patent Owner, Stelmasiak remarks on there being “no correlation” between the magnitude of lymphocyte reduction and the drug dose expressed per kg of body weight; similarly, Patent Owner cites Stelmasiak’s disclosure that “there was no indication that a ‘good response’ is related to the actual cladribine dose per body weight.” Id. (citing Ex. 1013, 6–7) (emphasis omitted). We do not agree that this rises to a teaching away. These cited disclosures relate to Stelmasiak’s attempt to explain the observed variance in lymphocyte counts among its patients, and to identify “any factor” that might have differentiated between those patients that were responders versus the non-responders. Ex. 1013, 6–7. Stelmasiak was “unable” to identify such a factor. But Stelmasiak nowhere teaches that expressing dosages in mg/kg and administering those dosages would result in a less effective or ineffective MS treatment. To the contrary, at most, Stelmasiak suggests that doing so would not have changed the results for its study and patient group. We also note that other technical literature of record describes cladribine studies where dosages are expressed in mg/kg form and recognizes a dose-dependent effect, including on the level of lymphocyte reduction. See, e.g., Ex. 1002 ¶¶ 91–92 (discussing Rice (Ex. 1018) (noting dose-dependent reduction in lymphocyte counts and lesion volume) and Selby (Ex. 1047)). Patent Owner’s “teaching away” argument is also weakened by Bodor, which, while teaching a regimen based on an alleged “flat” dosing (10 mg/day), defines “effective amount[s]” for MS treatment by referencing dosages expressed on a mg/kg basis—“from about 0.04 to about 1.0 mg/kg/day.” Ex. 1022, 22:17–22, 23:15–20. Whatever distinction Patent Owner seeks to erect between so-called “flat” and “weight-based” dosing is differentiator.” slip op. at 43
Claim construction§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 7,713,947 - Nespresso USA, Inc. v. K-Fee System GmbHInstitutedPTAB · Sep 13, 2023 · IPR2023-00502 · APJ Grace Karaffa Obermann · IPR · Institution
Instituted IPR on claims 1–16 because Petitioner showed a reasonable likelihood that the claims would have been obvious over Yoakim, Jarisch, and Rapparini.
In the decision…of claims 1, 5, 7 and 13. Prelim. Resp. 35–43. The parties also disagree about whether Petitioner shows sufficiently a reason to combine the teachings of Yoakim, Jarisch and Rapparini in the manner claimed. Id. at 44–45. We address each disputed issue in turn. 4. Analysis: Claim 1…
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2022). The standard for institution is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless the Director determines . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least [one] of the claims challenged in the petition.” For the reasons set forth below, Petitioner demonstrates a reasonable likelihood of prevailing with respect to claims 1–16 of the ’923 patent. Accordingly, we institute an inter partes review.” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“benefit of the filing date of an earlier filed application only if the disclosure of the earlier application provides support for the claims of the later application, as required by 35 U.S.C. § 112.” In re Chu, 66 F.3d 292, 297 (Fed. Cir. 1995). One may show support for the claims of a later application by showing that a single, earlier application provides written description support for the claims. PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1306 (Fed. Cir. 2008); Studiengesellschaft Kohle, MBH v. Shell Oil Co., 112 F.3d 1561, 1564 (Fed. Cir. 1997) (noting that a patentee “cannot distinct previous applications”). Once Petitioner identifies a prior art reference with an effective filing date prior to that of the challenged patent, the burden of production to show entitlement to the benefit of the filing date of an earlier filed application shifts to Patent Owner. See In re NTP, 654 F.3d 1268, 1276 (Fed. Cir. 2011) (“a patent’s claims are not entitled to an earlier priority date merely because the patentee claims priority . . . Rather, for a patent’s claims to be entitled to an earlier priority date, the patentee must demonstrate that the claims meet the requirements of 35 U.S.C. § 120”). Patent Owner may show possession of the invention through “such descriptive means as words, structures, figures, diagrams, formulas, etc., that fully set forth the claimed invention.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). “Although the exact terms need not be used in haec verba, . . . the specification must contain an equivalent description of the claimed subject matter. A description which renders obvious the invention for which an earlier filing date is sought is not sufficient.” Id.” slip op. at 9
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artPriority date, deniedDecided for petitioner
“Once Petitioner identifies a prior art reference with an effective filing date prior to that of the challenged patent, the burden of production to show entitlement to the benefit of the filing date of an earlier filed application shifts to Patent Owner. See In re NTP, 654 F.3d 1268, 1276 (Fed. Cir. 2011) (“a patent’s claims are not entitled to an earlier priority date merely because the patentee claims priority . . . Rather, for a patent’s claims to be entitled to an earlier priority date, the patentee must demonstrate that the claims meet the requirements of 35 U.S.C. § 120”). Patent Owner may show possession of the invention through “such descriptive means as words, structures, figures, diagrams, formulas, etc., that fully set forth the claimed invention.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). “Although the exact terms need not be used in haec verba, . . . the specification must contain an equivalent description of the claimed subject matter. A description which renders obvious the invention for which an earlier filing date is sought is not sufficient.” Id.” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“7. Analysis: Reasons to Combine the References Petitioner shows sufficiently that Yoakim, Jarisch and Rapparini are “analogous art in the field of portion capsule beverage extraction, each disclosing an invention that may be applied in automatic coffee/espresso machines.” Pet. 43. “Yoakim and Jarisch both improve the optimization of beverage parameters in a single-serve brewing system, and use optical codes read by the machine to achieve this.” Id. “Rapparini further improves the the wall of the capsule body like those used in Yoakim and Jarisch.” Id. at 43–44; see id. at 50–51, 53–54 (Petitioner’s further argument that Rapparini discloses “an optimized capsule structure that is stiffer and more stable” by virtue of radially spaced and vertically oriented ribs and grooves, where the vertically oriented grooves are free from extending entirely to the bottom region of the capsule). Petitioner directs us to additional evidence tending to establish that an ordinarily skilled artisan would have been prompted to modify Yoakim’s device, to include the code placement of Jarisch and the grooves and ribs of Rapparini, to arrive at the claimed invention with an expectation of success. Id. at 44–48.” slip op. at 27
§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,994,923 - PTAB · Aug 30, 2023 · IPR2023-00521 · APJ Jon B Tornquist · IPR · Institution
The Board instituted IPR on claims 19–61 and 63–81 on all petitioned grounds, finding a reasonable likelihood that Doud anticipates claims 19–61 and 63–75.
In the decision…asserts, however, that one of ordinary skill in the art would have restricted the size of the microparticles to no more than 50 µm in view of Xu’s teaching that additive particles within this size range “provide for strengthening of the metal composite.” Id. at 67 (citing Ex. 1007 ¶ 38). Patent…
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314 (2018); 37 C.F.R. § 42.4(a) (2022). The standard for institution is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless the Director determines . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons set forth below, we determine that Petitioner demonstrates a reasonable likelihood of prevailing with respect to at least one claim of the ’740 patent. Accordingly, we grant institution of an inter partes review.” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther
“the application describe the claim limitations exactly,” the application must demonstrate to persons of ordinary skill in the art that the applicants invented a composition including those limitations. Wertheim, 541 F.2d at 262. On its face, the range of “at least 0.01 wt. %” encompasses a range that is broader than 0.01–35 wt. %, and Patent Owner does not sufficiently explain why a person of ordinary skill in the art would understand from merely a disclosure of 35 wt.% that the inventors were in possession of the entire claimed range for copper, cobalt, or nickel in the magnesium composition.” slip op. at 11
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedOther
“On this record, the term “at least 0.01 wt. %” in the ’740 patent encompasses values for nickel, copper, and cobalt that are higher than the 35 wt. % (nickel and copper) and 20 wt. % (cobalt) limits outlined in the parent and grandparent applications. Accordingly, we determine that there is a reasonable likelihood that claim 19 of the ’740 patent is not entitled to the benefit of the filing dates of its priority applications. Challenged claims 20–61 and 63–75 depend from claim 19 and there is no argument presented that these claims have independent written description support in Doud. For example, there is no evidence presented that any of these dependent claims narrow the ranges for each of copper, nickel, and cobalt recited in in the ’295 application for these claims.7 Accordingly, for purposes of this Decision, we apply Doud as prior art to challenged claims 19–61 and 63–75.” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“as the ’740 patent. For example, Doud and the ’740 patent both disclose a method of forming a novel magnesium composite that includes melting an AZ91D magnesium alloy containing 90 wt. % magnesium, 9 wt. % aluminum, and 1 wt. % zinc. Ex. 1005 ¶¶ 45, 47; Ex. 1001, 21:43–51, 22:48–53, 33:32–43, 34:9–12. To this alloy is added either 7 wt. % nickel or 10 wt. % copper. Ex. 1005 ¶¶ 45, 47, 53, 57; Ex. 1001, 21:48–51, 22:53–56, 33:35–36, 34:12–13. These additives are mixed in the magnesium alloy at a temperature that is less than the melting point of copper or nickel, and the casting is then cooled. Ex. 1005 ¶¶ 45, 47, 53, 57; Ex. 1001, 21:51–54, 22:56–58, 33:35, 34:12-13. Doud reports that nickel and copper, when added to molten magnesium, will form Mg2Ni and CuMg2 intermetallic, galvanically-active, in situ precipitates. Ex. 1005 ¶¶ 12–13. Doud discloses that the dissolution rate of the resulting casting material is either 325 mg/cm2-hr (nickel) or 50 mg/cm2-hr (copper) in a 3% KCl solution at 90° C. Ex. 1005 ¶¶ 45, 47, 53, 57; Ex. 1001, 21:60–62, 22:61–63, 33:41–43, 34:15–17. Doud also discloses that the average particle diameter of the additives used in the invention is generally “at least about 0.1 microns” and “typically no more than about 500 microns.” Ex. 1005 ¶ 6. Petitioner explains how the identified disclosures of Doud anticipate independent claim 19. Pet. 39–40. Petitioner also identifies where the limitations of dependent claims 20–61 and 63–75 are disclosed in Doud. Id. at 41–45. Patent Owner does not address Petitioner’s anticipation arguments with respect to claims 19–61 and 63–75, apart from arguing that Doud is not prior art to these claims. Prelim. Resp. 27–39. demonstrates a reasonable likelihood that claims 19–61 and 63–75 are anticipated by Doud.” slip op. at 16
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialPatents in suitUS 10,689,740 - PTAB · Aug 8, 2023 · IPR2023-00545 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–9, 13–19, and 21–29 on all three grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
In the decision…IPR2023-00545 Patent 11, 299,783 B2 1334 (Fed. Cir. 2009). In evaluating anticipation, it is permissible to take into account not only the literal teachings of the prior art reference, but also the inferences the skilled artisan would draw from it. Eli Lilly and Co. v. Los Angeles Biomedical Res.…
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has demonstrated a reasonable likelihood that at least one claim of the ’783 patent is unpatentable, we institute an inter partes review of all challenged claims on each of the grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); see also Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018) (available at https://www.uspto.gov/patents-application-process/patent-trial-and-appeal-board/trials/guidance-impact-sas-aia-trial) (“Guidance”). C. Real Parties-in-Interest” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Relying on the testimony of Dr. Quackenbush, Petitioner asserts that a person of ordinary skill in the art (“POSA”) would have had: 1) an advanced degree (such as an M.D. or the equivalent of a Ph.D. in a life or physical sciences, engineering, or mathematics discipline) . . . 2) an understanding of various sequencing and next generation sequencing methods, sample preparation methods, targeted enrichment methods, bioinformatics methods for interpreting sequencing data, and methods for identifying genetic variants in a sample . . . . 3) an understanding of clinical applications of sequencing technology to conditions associated with nucleic acid variation, such as cancer, non-invasive prenatal testing, and transplant rejection . . . [and] 4) an understanding of cancer biology as it relates to mutations associated with tumor diagnosis, progression, and treatment, as well as awareness of the various types of mutations that can occur in and influence the course of a patient’s cancer. Pet. 4–5 (citing Ex. 1020 ¶¶ 35) (numbering added). Patent Owner does not presently challenge Petitioner’s definition. Prelim. Resp. 11. Based on the record before us, Petitioner’s proposed definition is consistent with the level of skill indicated in the cited references and the problems addressed in the ’783 patent. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). For purposes of this Decision, we provisionally adopt Petitioner’s proposed definition of the person of ordinary skill in the art.” slip op. at 19
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“In general, “the preamble does not limit the claims.” Allen Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336, 1346 (Fed. Cir. 2002). Moreover, “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, the preamble is not a claim limitation.” Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997). Considering the record before us, the preamble of claim 1 merely recites a purpose or intended use for the claimed method. In general, steps (a) through (c) in the body of claim 1 require the use of “a personalized probe set” to identify the presence or absence of genetic variants in a subject, whereupon this information is used to generate a report in step (d). We presently read the body of claim 1 to define a 7 Pointing to isolated passages in the Specification, Patent Owner further contends that, “methods that existed at the time of invention were specific to a particular disease or cancer rather than personalized to a specific subject’s family genetics,” whereas the claimed method “is directed to personalized genetic testing and is ‘better focused on the personal characteristics of the subject.’” Prelim. Resp. 20–21 (citing Ex. 1001, 4:37–47, 31:27–28). We find this argument confusing, as we do not presently read the challenged claims as limited to a “subject’s family genetics.” 8 To the extent Patent Owner maintains that the preamble is both limiting and distinguishes over the applied prior art, Patent Owner should clearly and explicitly identify during trial how it proposes the preamble should be construed—identifying evidentiary support for such construction according to well-established precedents. complete invention, with the preamble merely stating a purpose or intended use, or, in another sense, simply the result of carrying out the positively recited steps of the claim. As such, we do not presently view the preamble of claim 1 to be limiting and accord it no patentable weight.” slip op. at 21
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“2) “nucleic acid probe molecules” Claim 1 recites the use of “nucleic acid probe molecules . . . configured to selectively enrich or amplify sequences.” Relying on the testimony of Dr. Quackenbush and disclosure of the ’783 patent, Petitioner contends that one of ordinary skill in the art “would have understood that the claimed ‘nucleic acid probe molecules’ include PCR primers, hybrid capture baits, and other such nucleic acid probe molecules for selectively amplifying or enriching sequences.” Pet. 15 (citing Ex. 1020 ¶ 95; Ex. 1001, 4:60–61, 5:23–25, 7:5–8, 7:25–26). At this stage of the proceeding, Patent Owner does not address the meaning of “nucleic acid probe molecules.” Although the term is not presently contested, Petitioner’s definition is reasonable in light of the present record, and we provisionally adopt it for clarity.” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,299,783 - Nextremity Solutions, Inc. / Zimmer Biomet Holdings, Inc. et al. v. Extremity Medical, LLCAll claims unpatentablePTAB · Jul 26, 2023 · IPR2022-00802 · APJ Jeffrey N Fredman · IPR · Final written decision
Claim 59 is unpatentable as anticipated by Brumfield, Marcus, and Chandran; the motion to amend proposing substitute claim 62 is denied because claim 62 is unpatentable.
In the decision…present invention.” Ex. 1001, 3:7–8. 4 IPR2022-00802 Patent 8,303,589 B2 Figure 1 shows a fixation system 100 which is made in accordance with the teachings of the preferred embodiment of the invention. As shown, the fixation system 100 includes an intramedullary fixation assembly 110, comprising…
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“We find this argument unpersuasive. As Patent Owner notes, Petitioner’s expert provides a definition of POSITA that is very similar to that recited by Patent Owner in its Motion to Amend, substantively differing only in the number of years of experience of the engineer at issue. This congruity supports the conclusion that the level of ordinary skill in the art may be recognized in the prior art itself. Okajima, 261 F.3d at 1355 (“the absence of specific findings on the level of skill in the art does not give rise to reversible error ‘where the prior art itself reflects an appropriate level and a need for testimony is not shown’”).” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“In our Institution Decision, we agreed with Petitioner that the “portion of the preamble reciting ‘for compressing bone’ is not limiting to the claim” and found that other terms did not require construction. Dec. 8–9. We agreed with Petitioner that “[t]he phrase ‘for compressing bone’ merely identifies an intended use.” Pet. 20; Dec. 9. Patent Owner does not dispute this interpretation. See generally PO Resp. We agree with Petitioner that “the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). Therefore, having considered the entire record developed during trial, we adhere to the preliminary construction that the limitation “for compressing bone” does not impose a structural limitation on claim 59 and that the other terms do not require construction.” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Patent Owner disputes the Petition generally but Patent Owner does not identify any error in Petitioner’s foregoing arguments. Accordingly, we adopt the factual statements regarding the specific teachings of the references as findings of fact. See generally In re NuVasive, 841 F.3d 966, 974 (Fed. Cir. 2016) (explaining that the Board need not make specific findings as to claim limitations that Patent Owner does not dispute are disclosed in the prior art). We have reviewed Petitioner’s analysis and the underlying evidence cited in support and conclude that Petitioner has shown, by a preponderance of the evidence, that the limitations of claim 59 are disclosed by Brumfield.” slip op. at 26
- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend, deniedDenied
“For the reasons discussed below, Patent Owner has shown that proposed substitute claim 62 meets the statutory and regulatory requirements set forth in 35 U.S.C. § 316(d) and 37 C.F.R. § 42.121. For the reasons discussed below, however, Petitioner has proven by a preponderance of the evidence that proposed substitute claim 62 is unpatentable over prior art. Therefore, we deny Patent Owner’s Revised Motion to Amend.” slip op. at 38
Patent outcomesUS 8,303,589 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · NautilusPatents in suitUS 8,303,589 - PTAB · Jun 13, 2023 · IPR2023-00224 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–19 on all three asserted § 103 grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
In the decision…claimed by the patent at issue.” Id. at 418. “[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d…
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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). slip op. at 13
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Contrary to Patent Owner’s assertion that Petitioner seeks to describe “a person of exceptional skill,” Petitioner’s proposed definition merely indicates that one of ordinary skill in the art would have “an understanding” of relevant techniques and methods in the art. See id. at 12; Pet. 8. In particular, we read the “understanding” language of Petitioner’s proposed definition to take into account the level of skill in the art as reflected in the prior art of record—including the asserted art and that cited on pages 12–14 of Patent Owner’s Preliminary Response. Cf. 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) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). In addition to an understanding of the relevant art, the parties are, nonetheless, welcome to address at trial whether one of ordinary skill in the art would have had actual experience with next generation sequencing techniques, the analysis of NGS data, and/or some level of specialization in the field of bioinformatics.” slip op. at 17
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“In considering the scope of “whole genome sequencing” we take particular note of the Specification’s distinction between whole genome sequencing and targeted sequencing of the exome or other sub-genomic regions (e.g., Ex. 1001, 5:38–59, 24:35–58), as well as the Specification’s acknowledgement that whole genome sequencing may encompass “low mean coverage regions” and “zero mean coverage regions,” (id. at 24:59–62, 28:33–42). In this respect, we find it pertinent that Leary’s PARE studies began with sheared genomic DNA, and presumably resulted in non-targeted, randomly-distributed sequencing reads throughout the genome.10 We also find it pertinent that Forshew, a contemporary of Leary, described the matepaired technique as employed in Leary’s PARE approach as whole genome sequencing. Ex. 1030, 10. In light of the evidence and argument presently of record, we preliminarily interpret “whole genome sequencing,” as used in claim step 1(b), to mean “a non-targeted approach to sequencing all or almost all of a genome.” The panel may reconsider on the more complete record developed at trial, whether one of ordinary skill in the art would have understood that Leary’s mate-paired / PARE approach to detecting genomic rearrangements to teach or suggest sequencing all or almost all of the genome. See Ex. 1020” slip op. at 22
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“More importantly, in determining obviousness, “a reference . . . is prior art for all that it teaches.” Beckman Instruments, Inc. v. LKB Produkter AB, 892 F.2d 1547, 1551 (Fed. Cir. 1989). Considering the comparison of serial tumor samples illustrated in Ley’s Figure 3, and the related testimony of Dr. Quackenbush (Ex. 1020 ¶¶ 81–82), we presently agree with Petitioner that one of ordinary skill in the art reading Ley, “would have been motivated to include known mutations (such as those derived from a database of known cancer mutations) in a panel of polymorphisms for serial monitoring at multiple time points; and (ii) that a POSA would have had a reasonable expectation of success in successfully monitoring such polymorphisms.” See Pet. 56–57. And to be clear, at this stage of the proceeding, Patent Owner presents no credible evidence of teaching away. For the reasons set forth with respect to Leary in Ground 1, and having further considered the arguments and evidence with respect to the combination of Leary and Ley in Ground 2, we determine that Petitioner has demonstrated a reasonable likelihood that claims 1–11 and 13–19 are unpatentable in view of Leary and Ley.” slip op. at 36
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,384,394 - PTAB · Jun 13, 2023 · IPR2023-00317 · APJ Robert A Pollock · IPR · Institution
The Board instituted inter partes review of claims 1–23 on all petitioned grounds after finding a reasonable likelihood that at least one challenged claim is unpatentable.
In the decision…In re Gleave, 560 F.3d 1331, 1334 (Fed. Cir. 2009). In evaluating anticipation, it is permissible to take into account not only the literal teachings of the prior art reference, but also the inferences the skilled artisan would draw from it. Eli Lilly and Co. v. Los Angeles Biomedical Res.…
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“record, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least one challenged claim of the ’033 patent is unpatentable. We therefore institute trial on all challenged claims under the grounds raised in the Petition. See PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (indicating that a decision whether to institute an inter partes review “require[s] a simple yes-or-no institution choice respecting a petition, embracing all challenges included in the petition.”); Guidance, 2–3; 37 C.F.R. § 42.108. At this stage of the proceeding, we have not made a final determination with respect to the patentability of any of the challenged claims.” slip op. at 40
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Contrary to Patent Owner’s assertion that Petitioner seeks to describe “a person of exceptional skill,” Petitioner’s proposed definition merely indicates that one of ordinary skill in the art would have “an understanding” of relevant techniques and methods in the art. See id. at 10; Pet. 6. In particular, we read the “understanding” language of Petitioner’s proposed definition to take into account the level of skill in the art as reflected in the prior art of record—including the asserted art and that cited on pages 10–12 of Patent Owner’s Preliminary Response. Cf. 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) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). In addition to an understanding of the relevant art, the parties are, nonetheless, welcome to address at trial whether one of ordinary skill in the art would have had actual experience with next generation sequencing techniques, the analysis of NGS data, and/or some level of specialization in the field of bioinformatics.” slip op. at 16
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“In view of the above, we preliminarily conclude that one of ordinary skill reading the ’033 patent would understand that there is no discernable physical distinction between capture probes and amplification primers, and that Patent Owner’s functional distinction—hybridizing to target DNA so as to form subsets of molecules that are/are not hybridized—is a commonly desired trait for nucleotides used as in hybridization-based methods including PCR. Considering the argument and evidence presently of record, we agree with Petitioner that the claimed “capture probes” encompass, at a minimum,10 PCR primer capture probes and solution-based hybridization capture probes (e.g., biotinylated oligonucleotide baits).” slip op. at 24
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Forshew’s capture probes hybridize to a plurality of polymorphisms because, upon replication, its PCR primers hybridize to DNA fragments containing a plurality of polymorphisms, for example, known point mutations in cancer-related genes. Patent owner, by contrast, more narrowly interprets claim step 1a as requiring that, absent replication, the nucleotide sequence of Forshew’s PCR primers must, encompass and hybridize to, polymorphic target sites. This issue may benefit from further exploration at trial. For the purpose of institution, however, we rely on Dr. Quackenbush’s testimony that one of ordinary skill in the art would have “understood that Forshew’s PCR primer capture probes are the claimed ‘capture probes’ because they are nucleic acid sequences that ‘hybridize to’ the complementary sequences on the nucleic acid harboring the polymorphic gene.” Ex. 2020 ¶ 121; see also id. ¶¶ 119–120, 122–123.” slip op. at 26
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 11,408,033 - Samsung Electronics Co., Ltd. v. Lynk Labs, Inc.All claims unpatentablePTAB · Jun 7, 2023 · IPR2022-00100 · APJ Scott Raevsky · IPR · Final written decision
Claims 8–10 and 15–18 are unpatentable as obvious over Piepgras, Michael, and Butler, with Schultz or Naskali added for claims 16 and 17.
In the decision…parties, we find Petitioner’s arguments more persuasive. For instance, we find 19 IPR2022-00100 Patent 10,750,583 B2 persuasive Butler’s express teaching that a touch screen would have provided benefits for disabled persons: Touch access enables specific embodiments to be especially suitable…
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Petitioner contends that there is “no meaningful dispute over [the definition of] a POSITA.” Reply 1. We agree. However, we adopt Patent Owner’s definition of the level of skill because we are persuaded that it is more consistent with the problems and solutions in the ’583 patent. In particular, Patent Owner’s definition requires experience with LED devices, whereas Petitioner’s definition makes LED experience optional (“experience with LED devices and/or related circuit design”). We note that the outcome of this decision would not have changed had we adopted Petitioner’s definition.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties propose no constructions. Pet. 7; PO Resp 8–9; Reply 1. At institution, we discussed the meaning of the term “array.” Dec. 16 n.12. Patent Owner traverses this construction and submits that “no special construction for ‘LED array’ is needed,” as it does not dispute any limitation reciting an “LED circuit array.” See PO Resp. 9. We agree. Based on our review of the record, no terms need to be construed. See Realtime Data, LLC v. Iancu, 912 F.3d 1368 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“fails to identify any deficiencies or drawbacks of Piepgras’s two-button remote control because the law does not require Petitioner to identify problems with a reference in order to establish obviousness. See PO Resp. 28–30; In re Heck, 699 F.2d 1331, 1333 (Fed. Cir. 1983) (“The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.”). What the Petition must demonstrate is that there was some reason why one of ordinary skill in the art would have sought to combine the elements of the prior art in the manner proposed. KSR, 550 U.S. at 418. The Petition provides multiple, persuasive reasons (discussed above) as to why one of ordinary skill in the art would have sought to use a touch screen, as disclosed in Butler, to permit user control of a remote control, as disclosed in Piepgras.” slip op. at 21
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“Petitioner argues, and we agree, that the Piepgras-Michael-Butler combination discloses that the portable telecommunications device can detect a human touch. Pet. 43. Further, Dr. Baker testifies, and we agree, that a POSITA would have understood that the modified device “would use an LED touch display and thus when touched, the LED(s) of the display would change (e.g., turning on and/or changing interface content).” Ex. 1002 ¶ 141. We credit this testimony by Dr. Baker because it is well-supported by evidence. See, e.g., Exs. 1009 (Hack), 1022 (Gillespie); Pet. 43 (citing same).13 Patent Owner does not offer any contrary evidence that would undermine Dr. Baker’s persuasive testimony that a POSITA would have understood that the modified device would use an LED touch display and that when touched, the LED(s) of the display would change (and thus provide light). See Ex. 2001 ¶¶ 105–16 (attacking the sufficiency of Petitioner’s evidence but not disputing Dr. Baker’s core assertion regarding the understanding of a POSITA). It is somewhat ironic that Patent Owner asserts that Dr. Baker’s testimony is “conclusory and not tied to supporting evidence.” Sur-reply 26 (citing Ex. 1002 ¶ 141). In reality, Petitioner supplies ample supporting evidence (e.g., Hack and Gillespie), but Patent Owner denies that we can consider it. See, e.g., Pet. 43 (citing, e.g., Exs. 1009, 1022); PO Resp. 44. Petitioner’s reliance on evidence to show the understanding of a skilled artisan is appropriate because “the obviousness ‘analysis requires an assessment of the . . . background knowledge possessed by a person having ordinary skill in the art.’” Koninklijke Philips, 948 F.3d at 1337. Petitioner does not rely upon references such as Hack and Gillespie to supply a missing claim limitation.14 Rather, Petitioner relies on Butler’s disclosure of a touch screen for this limitation and points to Hack and Gillespie to show that prior art touch screens often included LED displays and that one of ordinary skill in the art would have understood that a touch screen would have provided 13 As we explain below, we need not rely on Swartz. 14 For this reason, Petitioner need not have included Swartz, Hack, or Gillespie in its ground listing, and Petitioner need not show a motivation to combine Swartz, Hack, or Gillespie with Piepgras, Michael, and Butler. light based upon detection of human touch. Reply 20; see also Pet. 43. Arendi is therefore inapposite because Petitioner’s detailed explanations and supporting evidence are the opposite of relying on “common sense” as a “wholesale substitute for reasoned analysis and evidentiary support.” See 832 F.3d at 1362.” slip op. at 33
Patent outcomesUS 10,750,583 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,750,583
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.