- Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution deniedPTAB · Oct 2, 2023 · IPR2023-00723 · APJ Robert A Pollock · IPR · Institution
The Board denied institution on claims 1–6 because Petitioner did not show a reasonable likelihood that any challenged claim was unpatentable under the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“In an [inter partes review], 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) (2012) (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). A claim is unpatentable under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). The question of obviousness is resolved on the basis of underlying factual determinations including: (1) the scope and content of the prior art; (2) any differences between the claimed subject matter and the prior art; (3) the level of ordinary skill in the art; and (4) objective evidence (1966). In analyzing the obviousness of a combination of prior art elements, it can be important to identify a reason that would have prompted one of skill in the art “to combine . . . known elements in the fashion claimed by the patent at issue.” KSR, 550 U.S. at 418. A precise teaching directed to the specific subject matter of a challenged claim is not necessary to establish obviousness. Id. Rather, “any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” Id. at 420. Accordingly, a party that petitions the Board for a determination of unpatentability based on obviousness must show 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 success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (internal quotations omitted). slip op. at 9
- Skill levelSkill level petitioner adoptedDecided for petitioner
“In determining the level of skill in the art, we consider the type of problems encountered in the art, the prior art solutions to those problems, the rapidity with which innovations are made, the sophistication of the technology, and the educational level of active workers in the field. See Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 955, 962 (Fed. Cir. 1986); see also Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. Id. at 7–8 (citing Ex. 1020 ¶ 27; Ex. 1022 ¶ 27; Ex. 1024 ¶ 21; Ex. 1026 ¶¶ 25–26). 13 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’343 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) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). C. Claim Construction” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We interpret a claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2020). Under this standard, we construe the claim “in accordance with the ordinary and customary meaning of such claim as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent.” Id. Moreover, “the specification ‘is always highly relevant to the claim construction analysis. Usually it is dispositive; it is the single best guide to the meaning of a disputed term.’” In re Abbott 13 We need not consider Petitioner’s similar alternative definitions. See id. at 8–9. v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc)). The parties contend that no claim term requires construction. Pet. 13. Prelim. Resp. 15. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only 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))). D. Overview of Asserted References” slip op. at 12
- Expert testimonyPetitioner expert discountedDecided for patent owner
“On the record before us, however, Dr. Flatt’s assessment of the relative benefit one of ordinary skill in the art would have accorded the higher Ki of mono-substituted compound 3 as compared to the “much longer plasma half-life” of Dong’s bi-substituted compounds is at odds with Dong’s selection of bi-substituted compound 4 for clinical trials. See Ex. 1013, 670– 671 (Table 1). We are also skeptical of Dr. Flatt’s assertion that one of ordinary skill in the art would have recognized that Dong’s substitution of Aib for alanine at position 8 “would complement and work synergistically with liraglutide’s [other] properties,” including the fatty acylation of Lys26. See Ex. 1020 ¶ 181. In this respect, Patent Owner notes that, unlike liraglutide, Dong’s GLP-1 analogs were not acylated, whereas Knudsen 2001 counseled against N-terminal modifications in the context of acylation. Prelim. Resp. 28–30, 46 (citing Ex. 1011, 680–681). In addressing such combinations, Knudsen 2001 states, for example, that “Desamino His7 represents one of the more potent suggestions to a modification giving metabolic stability (81 ). Nevertheless, as seen when comparing 19 (687 pM) to 5 [liraglutide] (68 pM), considerably more potent compounds could be obtained by not modifying the N-terminus when a combination with acylation was desired.” Id. at 680. As such, we are unpersuaded on the record before us that one of ordinary skill in the art would have had a reasonable expectation that the Aib8 modification would be beneficial or otherwise “complement and work synergistically with” the acylated Lys26 of liraglutide or semaglutide. See Ex. 1020 ¶ 181.” slip op. at 30
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 8,129,343 - Mylan Pharmaceuticals Inc. v. Novo Nordisk A/SInstitution deniedPTAB · Oct 2, 2023 · IPR2023-00722 · APJ Robert A Pollock · IPR · Institution
Institution was denied for claims 1, 2, 4–11, 13, and 15 because Petitioner did not show a reasonable likelihood of proving them obvious under any of the three grounds.
RulingsInstitution decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In addressing the level of ordinary skill in the art, Petitioner contends that “[t]he claimed subject matter falls within the medicinal chemical and pharmacological arts and encompasses the skills, education, and expertise of a team of individuals working together to develop and formulate GLP-1 analogs to treat patients having type-2 diabetes or related conditions.” Pet. 7. The persons of ordinary skill in the art (“POSA”) making up the team would have an M.D., Pharm.D., or doctoral degree(s) in chemistry, biochemistry, pharmaceutics, pharmaceutical sciences, chemical engineering, biochemical engineering or related fields, with at least two years of experience in developing therapeutic peptides or proteins, and experience with the development, design, manufacture, formulation, or administration of therapeutic peptides or proteins, and the literature concerning protein or peptide formulation and design or diabetes treatments. ¶ 24).14 Patent Owner does not offer a different level of ordinary skill in the art. See generally Prelim. Resp. On the current record, and for the purposes of this decision, we accept Petitioner’s proposed definition, as it appears consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’122 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) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)).” slip op. at 14
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties contend that no claim term requires construction. Pet. 16. Prelim. Resp. 16. Having considered the record, we determine that no express claim construction of any claim term is necessary to reach our 14 We need not consider Petitioner’s similar, but alternative, definitions. See id. at 8–9. v. Matal, 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only 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 15
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“For the reasons provided below, we determine Petitioner has not satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Because Petitioner has not demonstrated a reasonable likelihood that at least one claim of the ’122 patent is unpatentable, we do not institute an inter partes review on the Grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360 (Fed. Cir. 2018) (interpreting the statute to require “a simple yesor-no institution choice respecting a petition, embracing all challenges included in the petition”); see also Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018).1” slip op. at 2
- BurdenNot shown unpatentable
“Considering the record before us, Petitioner has not shown sufficiently that one of ordinary skill in the art would be motivated to make the required modification with a reasonable expectation of success. (4) Hindsight and Reasonable Expectation of Success One of ordinary skill in the art seeking to modify liraglutide would need undertake at least four discrete steps to arrive at semaglutide—some of which entail multiple options and decision points (e.g., the selection and placement of di-AEEA, and whether to replace, or add to, the existing γ-glu linker). As discussed above, we find Petitioner’s justification for these individual steps problematic. Taken as whole, and considering the vast number of modifications suggested in the art—and indeed, the large number of amino acids suggested as cites for modification—Petitioner has failed to meet its burden of demonstrating why a skilled artisan would have been motivated to make all of the identified substitutions and no others. See e.g., Ex. 1010, 4130 (Figure 3) (identifying amino acids available for derivatization (Ser18, Gln23, Lys26, Glu27, Lys34, and Arg36) or modification (Ala8)); Ex. 1011, 680–681 (identifying desamino His7 as “one of the more potent suggestions to a modification giving metabolic stability,”); Ex. 1012 at, e.g., 9:21-19:59; 192:30–60 (Table 1), 193:35–46 (disclosing numerous GLP-1 analogs, including those with greater half-lives or potency than liraglutide, and teaching that each could be further modified, including with amino acid substitutions and/or acylation at multiple positions, numerous the fatty and amino acids); Ex. 1013, 670–671 (disclosing that GLP-1 analogs bearing modifications at both positions 8 and 35 maintain efficacy but “have much longer plasma half-life than mono-substituted compounds”).” slip op. at 43
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · GrahamPatents in suitUS 8,536,122 - Nespresso USA, Inc. v. K-Fee System GmbHInstitutedPTAB · Sep 13, 2023 · IPR2023-00485 · APJ Jon B Tornquist · IPR · Institution
Instituted IPR of claims 1–10 on all petition grounds; Petitioner showed a reasonable likelihood that the claims would have been obvious over Yoakim, Jarisch, Rossi, and Castellani.
RulingsInstitution decision- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“second German priority application do not disclose every limitation of independent claims 1 and 7 of the ’430 patent. Figure 1 does not depict a barcode under the flange, but rather the use of raised areas on the side of the capsule that act as an identifier. Ex. 1047, Fig. 1. Figure 2, coupled with its associated description, might suggest that the barcode could be on the portion of the base element facing away from the membrane,9 but this figure does not disclose many of the other elements of the claim, including holding arms, a drop box, annular convexity and concavity, and a pump to supply water to the single-serve capsule. Pet. 41; Ex. 1047, 9:21–24, Fig. 2. We also determine that Patent Owner does not sufficiently demonstrate that Figures 16–18 of the second German priority application provide adequate disclosures showing that the inventors were in possession 9 We question whether the second German priority application supports placing a barcode under the flange. The application states that the barcode could “be provided on that side of the peripheral region of the basic element which is directed away from the membrane.” Ex. 1047, 9:21–24. This statement is rather ambiguous as to where the “peripheral region” is that is “directed away from the membrane.” The text goes on to explain, however, that “[t]his barcode,” i.e., the barcode that is “directed away from the membrane,” “is read by a detector 13,” which in Figure 2 is oriented to read a barcode on the top surface of the flange. Id. at 9:25–26, Fig. 2. This suggests that the barcode is not on the bottom side of the flange and that arrow 15 is pointing to the outer portion of the peripheral region that is not covered by the membrane, and not necessarily the bottom of the flange. First, the second German priority application describes the use of “an identifier” that is read by a “sensor/detection means” and then compared to a stored identifier. Ex. 1047, 2:29–31. In Figure 2 the identifier may be a barcode and the detection means is detector 13. Id. at 9:11–26. In Figures 16–18, however, element 2.4.2 is not an identifier, but rather a “a form-fitting and/or friction-fitting means and/or a detection means.” Id. at 12:22– 24 (emphasis added). As such, it is unclear how this disclosure would demonstrate possession of the disputed claim limitation, when combined with the other limitations of claims 1 and 7 as a whole. Second, it is not evident that the toothed rings of Figures 16–18 are on the underside of the flange, as asserted by Patent Owner. Prelim. Resp. 42 (asserting that a barcode “could be located on the bottom side of the flange instead of the toothed ring”); Prelim. Sur-reply 4. The second German priority application states that the “form-fitting and/or friction-fitting means and/or detection means 2.4.2” is located in the “outer region” of the peripheral region 2.4. Ex. 1047, 12:22–24. We are directed to no evidence that this “outer region” is on the bottom of the flange, and Figures 16–18 each appear to depict means 2.4.2 on, or forming, the outer circumference of the flange.11 Id. at Figs. 16–18, 6:8–11 (noting that the toothed ring is provided “on the outer circumference of the periphery”). 10 The parties dispute whether Figure 16 of the second German priority application discloses annular convexity and concavity. Pet. 42–43; Prelim. Resp. 45–46; Prelim. Reply 4–5; Prelim. Sur-reply 4. At most, the parties identify a material issue of fact with respect to these two claim elements that is best resolved on a full trial record. 11 At first blush, Figure 17A appears to show means 2.4.2 under a portion of element 27 of the capsule. Ex. 1047, Fig. 17A; Prelim. Sur-reply 4 depicted in Figures 16–18, which rely on toothed rings physically interacting with either the chamber, retaining arms, or a pinion. Ex. 1047, 12:22–31, 13:8–18. The second German priority application explains that means 2.4.2 physically interacts with retaining arms 30 (embodiments of Figures 16 and 17) or a pinon (embodiment of Figure 18), and if means 2.4.2 were not present in these embodiments, the capsule would either “drop through into a waste container” or could not be inserted through the insertion shaft. Id. at 12:22–27, 13:9–12, 13:16–35 (noting that in the embodiment disclosed in Figure 18 a pinon interacts with means 2.4.2 and only when means 2.4.2 “is formed complementary to the teeth of the means” can the capsule be inserted). Patent Owner does not sufficiently explain how a barcode could replace means 2.4.2 in these embodiments and still retain the capsule within the device or allow the capsule to enter the insertion shaft.” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“First, Yoakim expressly states that the capsule may use a “barcode,” and the plain and ordinary meaning of this term is a code that satisfies the construction adopted by the district court. To the extent Patent Owner has reason to believe that Yoakim does not apply the plain and ordinary meaning of the term “barcode,” and that one of ordinary skill in the art would have understood this fact, it is encouraged to present such evidence during trial. Second, in this obviousness inquiry the question is not whether a person of ordinary skill in the art is more likely to adopt a barcode or a bitcode, but whether one of ordinary skill in the art would have seen a benefit to applying the “barcode” of Yoakim under the flange of the capsule. See Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 800 (Fed. Cir. 2021) (“Our case law is clear. It’s not necessary to show that a combination is ‘the best option, only that it is a suitable option.’”). On that point, Jarisch expressly discloses the benefits of doing so. Ex. 1005 ¶ 22 (noting that applying the code at the bottom of the rim lowers the risk of the code becoming unreadable). As such, we determine that Petitioner sufficiently identifies where Yoakim discloses a barcode and explains why one of ordinary skill in the art would have placed such a “barcode” on the bottom of the capsule’s flange.” slip op. at 27
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Information Disclosure Statement (IDS) during prosecution of the ’430 patent and that Rossi and Castellani were mentioned in the inter partes reviews that were cited on the IDS. Pet. 19; Prelim. Resp. 23. We need not determine whether Part 1 of the Advanced Bionics framework is satisfied based on these disclosures, however, as Part 2 of the analysis, which we address below, is dispositive. a) Factor (c)—the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for a rejection The Examiner did not issue any rejections during prosecution of the ’430 patent. Ex. 1002, 232–234. As the reasons for allowance, the Examiner stated: [A]llowance of claims 1 and 21–29 is indicated as none of the cited prior art discloses or suggests the flange comprising a top side and an opposing bottom side; a cover that is fastened to the top side of the flange to close the cavity; and an identifier provided on the bottom side of the flange, the identifier being a barcode, wherein the beverage machine, by reading or detecting the identifier with the sensor/detector, is configured to determine if the single-serve capsule belongs to a group of single serve capsules operable for use with the beverage machine, and only if the beverage machine determines that the single-serve capsule belongs to the group of single serve capsules operable for use with the beverage machine is the pump controlled to push the water into the single-serve capsule. Id. at 233. In arriving at this conclusion, the Examiner did not cite or discuss the disclosures of Yoakim, Jarisch, Rossi, or Castellani. Id. at 232–234. Yet, these references appear, based on the current record, to expressly teach or allowance, including a “flange comprising a top side and an opposing bottom side” (Ex. 1004 ¶ 197, Fig. 6); “a cover that is fastened to the top side of the flange to close the cavity” (Ex. 1004 ¶¶ 128–129, 197, 414); “an identifier provided on the bottom side of the flange” (Ex. 1005 ¶ 22) that is “a barcode” (Ex. 1004 ¶¶ 496, 525); and “reading or detecting the identifier with the sensor/detector . . . to determine if the single-serve capsule belongs to a group of single serve capsules operable for use with the beverage machine” (Ex. 1004 ¶¶ 25, 192, 477, 494–496, 525; Ex. 1005 ¶ 82; Ex. 1041, 3, 11). As such, to the extent the asserted combination of prior art references was evaluated during prosecution of the application that matured into the ’430 patent, we determine that such evaluation was minimal.” slip op. at 37
- Other 314aDecided for petitioner
“B. 35 U.S.C. § 314(a) Patent Owner contends that “[t]he parties have been embroiled in disputes involving substantive claims for infringement for both the ’430 Patent and the Jarisch 929 reference,” and “it is unnecessary to open up yet another front in this dispute.” Prelim. Resp. 68–69. As such, Patent Owner requests that we deny institution under 35 U.S.C. § 314(a). Id. Patent Owner directs our attention to no case in which the Director has exercised discretion to deny a petition merely because the same patent was the subject of a co-pending district court infringement action. Indeed, 35 U.S.C. § 315(b) specifically contemplates such a scenario. Accordingly, we decline to exercise discretion to deny the Petition under 35 U.S.C. § 314(a).” slip op. at 40
§ 103 obviousness§ 112 disclosureDiscretionary denialPatents in suitUS 11,230,430 - 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.
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 - Celltrion, Inc. v. Regeneron Pharmaceuticals, Inc.Institution deniedPTAB · Sep 1, 2023 · IPR2023-00620 · APJ Susan L C Mitchell · IPR · Institution
The Board denied institution because claims 1–4 had been statutorily disclaimed.
RulingsInstitution decision- Adverse judgmentAdverse judgmentDenied
“Under 37 C.F.R. § 42.107(e), “patent owner may file a statutory disclaimer under 35 U.S.C. 253(a) in compliance with § 1.321(a) of this chapter, disclaiming one or more claims in the patent” and “[n]o inter partes review will be instituted based on disclaimed claims.” A disclaimer under 35 U.S.C. § 253(a) is “considered as part of the original patent” as of the date on which it is “recorded” in the Office. 35 U.S.C. § 253(a). For a disclaimer to be “recorded” in the Office, the document filed by the Patent Owner must:” slip op. at 2
NonePatents in suitUS 10,406,226 - 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.
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 - Osteomed LLC v. Stryker European Operations Holdings LLCAll claims unpatentablePTAB · Aug 8, 2023 · IPR2022-00488 · APJ Susan L C Mitchell · IPR · Final written decision
Claims 1–3 and 6–18 are unpatentable as obvious over Arnould and Zahiri, with claim 6 also relying on Myerson; the Board did not reach Grounds 1–3.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“While both parties’ descriptions are similar, we find that Patent Owner’s description is better supported by the record. As Patent Owner points out, the main distinction between the parties’ proposals is that Patent Owner’s description is broader because it includes orthopedic surgeons. The record supports the inclusion of such individuals in the description of a POSITA. See Ex. 2005 ¶¶ 37, 41; Ex. 2009, 38:21–39:7 (Petitioner’s declarant testifying that he would “include an orthopedic surgeon that has some experience developing implants as a person of ordinary skill in the art”). Thus, we apply Patent Owner’s description of a POSITA for our analysis.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“That said, we do not agree with Patent Owner that the Specification defines “bone plate” as it contends. In the background of the invention, the Specification states that “[t]he invention relates to the technical field of orthopedic implants. More particularly, the invention relates to a plate for arthrodesis or osteosynthesis adapted to be fixed between two bone parts.” Ex. 1001, 1:27–31. Contrary to Patent Owner’s argument, this passage does not “define” the term “bone plate” nor otherwise suggest that the patentee acted as its own lexicographer. See Resp. 9. Moreover, nothing in the record suggests that the ordinary meaning of “bone plate” requires the plate to be fixed between two bone parts. The medical dictionaries Patent Owner cites do not include such a requirement in their definitions. See Ex. 2012, 1478 (defining “bone plate” as “a metal bar with perforations for the insertion of screws, used to immobilize fractured segments”); Ex. 2013, 241 (defining “bone plate” as “a metal plate used to reconstruct a bone that has been fractured” and “designed to hold the bone fragments in apposition”). Both of these definitions are consistent with Mr. Sherman’s testimony that a bone plate is “not always” placed across the fracture. See Ex. 2009, 52:9–53:1 (identifying particular instances in which a plate is not placed across the fracture). We credit that testimony over the competing testimony of Patent Owner’s declarant, Mr. Leinsing. Ex. 2005 ¶ 34 (referring to the statements from the Specification and dictionary definitions discussed above). For these reasons, we agree with Petitioner that the term “bone plate” as recited in the challenged claims has its ordinary meaning and that meaning does not exclude plates located on only one side of a joint or fracture.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“We do not agree that the ordinary meaning of “between” is as restrictive as Patent Owner contends. First, Patent Owner’s definition of “between” does not require an object that is “between” two others to lie along the same axis defined by the two other objects. A “space separating two objects” is not so restrictive. Instead, a more expansive ordinary meaning of “between” is evidenced by the intrinsic evidence of the ’751 patent as Petitioner explained with reference to Figure 2 of the ’751 patent, which shows a third hole 1a1 between the other holes even though it is “offset” and in a different plane from the longitudinal axis of the bone plate. Patent Owner attempts to draw a distinction between Arnould’s Figure 2 and Figure 2 of the ’751 patent, by asserting “like Arnould, a hand is in a different plane and offset and its axis is not in relation to the body. In contrast, the angled tab shown in Figure 2 of the ’751 patent is not in a different plane and offset from the plate, and the hole axis forms an angle with the plate.” Sur-reply 8. Patent Owner’s distinction here appears to be whether the third hole lies at an angle below or above the bone plate as shown in Figure 2 of the ’751 patent (which would be “between” according to Patent Owner) versus also being positioned to either side of the bone plate as shown in Figure 2 of Arnould (which in Patent Owner’s view would mean that hole is no longer “between” the others). We see no basis for drawing such a fine distinction regarding the meaning of “between,” especially when the narrower definition Patent Owner seeks is not made explicit in the Specification of the ’751 patent. To the extent any further claim construction is necessary to resolve” slip op. at 16
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“contends. A reference is considered to be analogous art if it is in the “same field of endeavor” as the patent at issue. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). Here, the Specification states that “[t]he invention relates to the technical field of orthopedic implants.” Ex. 1001, 1:27–28. Zahiri falls squarely within this field, describing “fixation devices for compressing bone fractures of a human being.” Ex. 1007, 1:9–11; see also, e.g., id. at Fig. 1 (depicting the use of Zahiri’s plate as an orthopedic implant to fix two bone parts). The differences Patent Owner identifies in Zahiri’s device do not show otherwise. In this regard, we find the testimony of Mr. Sherman (Ex. 1002 ¶ 245) on this point to be more credible than the competing testimony offered by Mr. Leinsing (see Ex. 2005 ¶¶ 121–29, 238). Mr. Sherman persuasively testifies that “Arnould and Zahiri disclose bone plates with diagonal fixation members configured to compress the intersection of a first and second bone,” demonstrating Arnould and Zahiri “are therefore in analogous fields of invention” to the ’751 patent. Ex. 1002 ¶ 245. Mr. Leinsing, on the other hand, continues to assert that Zahiri discloses only “a guide that directs a lag screw at a precise angle into a humeral head, not a bone plate” because it is located on only one side of the joint or fracture. Ex. 2005 ¶ 238. Therefore, Mr. Leinsing concludes that the “Zahiri device is directed to a completely different function than Arnould,” and is non-analogous art. Id. Because we find Zahiri discloses a “bone plate” according to the ordinary meaning of that term, Mr. Leinsing’s testimony is unconvincing. See supra § III.C.i (explaining that the ordinary meaning of “bone plate” does not exclude plates located on only one side of a joint or fracture). But even if we agreed with Patent Owner’s and Mr. Leinsing’s interpretation of bone plate, Zahiri’s plate is still an orthopedic implant and therefore analogous art because it is within the same field of endeavor as the ’751 patent.” slip op. at 34
Patent outcomesUS 10,993,751 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,993,751 - Osteomed LLC v. Stryker European Operations Holdings LLCAll claims unpatentablePTAB · Aug 4, 2023 · IPR2022-00487 · APJ Michael A Valek · IPR · Final written decision
Claims 32–39 are unpatentable: claims 32–39 over Arnould and Zahiri, and claims 34–35 also over Arnould and Myerson, with or without Zahiri.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“While both parties’ descriptions are similar, we find that Patent Owner’s description is better supported by the record. As Patent Owner points out, the main distinction between the parties’ proposals is that Patent Owner’s description is broader because it includes orthopedic surgeons. The record supports the inclusion of such individuals in the description of a POSITA. See Ex. 2005 ¶¶ 37, 41; Ex. 2009, 38:21–39:7 (Petitioner’s declarant testifying that he would “include an orthopedic surgeon that has some experience developing implants as a person of ordinary skill in the art”). Thus, we apply Patent Owner’s description of a POSITA for our analysis.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“That said, we do not agree with Patent Owner that the Specification defines “bone plate” as it contends. In the background of the invention, the Specification states that “[t]he invention relates to the technical field of orthopedic implants. More particularly, the invention relates to a plate for arthrodesis or osteosynthesis adapted to be fixed between two bone parts.” Ex. 1001, 1:18–22. Contrary to Patent Owner’s argument, this passage does not “define” the term “bone plate” nor otherwise suggest that the patentee acted as its own lexicographer. See Resp. 12–13. Moreover, nothing in the record suggests that the ordinary meaning of “bone plate” requires the plate to be fixed between two bone parts. The medical dictionaries Patent Owner cites do not include such a requirement in their definitions. See Ex. 2012, 1478 (defining “bone plate” as “a metal bar with perforations for the insertion of screws, used to immobilize fractured segments”); Ex. 2013, 241 (defining “bone plate” as “a metal plate used to reconstruct a bone that has been fractured” and “designed to hold the bone fragments in apposition”). Both of these definitions are consistent with Mr. Sherman’s testimony that a bone plate is “not always” placed across the fracture. See Ex. 2009, 52:9–53:1 (identifying particular instances in which a plate is not placed across the fracture). We credit that testimony over the competing testimony of Patent Owner’s declarant, Mr. Leinsing. Ex. 2005 ¶ 33 (referring to the statement from the Specification and dictionary definitions discussed above). For these reasons, we agree with Petitioner that the term “bone plate” as recited in the challenged claims has its ordinary meaning and that meaning does not exclude plates located on only one side of a joint or fracture. To the extent any further claim construction is necessary to resolve the issues presented in this proceeding, we consider such in our analysis below.” slip op. at 10
- Obviousness (§103) › Analogous artAnalogous artDecided for petitioner
“We disagree with Patent Owner for several reasons. First, the narrow construction of “bone plate” that Patent Owner proposes to distinguish Zahiri is not supported by the record. See supra § III.C. We agree with Petitioner that the ordinary meaning of “bone plate” includes plates like those described in Zahiri. Id. Second, even if Patent Owner’s construction were correct, the scope of analogous art is broader than Patent Owner contends. A reference is considered to be analogous art if it is in the “same field of endeavor” as the patent at issue. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). Here, the Specification states that “[t]he invention relates to the technical field of orthopedic implants.” Ex. 1001, 1:18–19. Zahiri falls squarely within this field of endeavor, describing “fixation devices for compressing bone fractures of a human being.” Ex. 1007, 1:9–11; see also, e.g., id. at Fig. 1 (depicting the use of Zahiri’s plate as an orthopedic implant to fix two bone parts). The differences Patent Owner identifies in Zahiri’s device do not show otherwise. In this regard, the testimony of Mr. Sherman (Ex. 1002 ¶ 191) on this point to be more credible than the competing testimony offered by Mr. Leinsing (see Ex. 2005 ¶¶ 124–31, 166). Mr. Sherman persuasively testifies that “Arnould and Zahiri disclose bone plates with diagonal fixation members configured to compress the intersection of a first and second bone or across a fracture,” demonstrating Arnould and Zahiri “are therefore in analogous fields of invention” to the ’713 patent. Ex. 1002 ¶ 191. Mr. Leinsing, on the other hand, asserts that Zahiri’s plate is not a bone plate because it is located on only one side of a fracture and therefore does not “span[] both sides of a bone discontinuity.” See Ex. 2005 ¶¶ 124–26, 131. For this reason, Mr. Leinsing concludes Zahiri is non-analogous art. Id. ¶ 131. Because we find Zahiri discloses a “bone plate” according to the ordinary meaning of that term, Mr. Leinsing’s testimony is unconvincing. See supra § III.C. (explaining that the ordinary meaning of “bone plate” does not exclude plates located on only one side of a joint or fracture). But even if we agreed with Patent Owner’s and Mr. Leinsing’s interpretation of bone plate, Zahiri’s plate is still an orthopedic implant and therefore analogous art because it is within the same field of endeavor as the ’713 patent.” slip op. at 23
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundMotivation foundDecided for petitioner
“Patent Owner’s argument that Zahiri teaches away from a combination with Arnould is also unavailing. See Resp. 54–57. Patent Owner asserts that unlike Arnould’s plate, Zahiri’s “rigid guide plate . . . does not allow a surgeon to conform the plate to the anatomy” and “[d]ue to the fixed angle design of Zahiri’s device, the surgeon cannot select the angle of insertion of the lag screw to adapt to the individualized needs of a particular patient.” Id. at 56. But those distinctions do not rise to the level of a teaching away. See Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013) (quoting DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009)) (“A reference does not teach away . . . if it . . . does not criticize, discredit, or otherwise discourage investigation into the invention claimed.”). Moreover, Petitioner’s combination is premised on modifying hole 25 in Arnould’s plate to have Zahiri’s angled holed configuration. That combination would retain Arnould’s flexible plate, while fixing or at least limiting the angle of screw 30 through the hole. However, Petitioner explains that “Zahiri discloses providing plates with a variety of angles in a kit so the surgeon can choose the plate that will maximize fixation based on the particular needs of the patient.” Reply 21; see also Ex. 1007, 3:59–64, 9:1–4 (teaching that the hole may configured in a range of angles to accommodate the device’s use “for a variety of fractures, fusion procedures and osteotomies”). Thus, a POSITA could compensate for the fixed angle and, in any event, the fact that one embodiment may be preferable in some instances does not teach away from the proposed combination. See UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 692 (Fed. Cir. 2023) (explaining that a teaching that one composition is “optimal or standard” or that expresses a “preference” for something does not teach away from other options) (internal quotations omitted).” slip op. at 24
Patent outcomesUS 9,078,713 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,078,713 - Syngenta Crop Protection AG v. Upl Ltd.InstitutedPTAB · Jul 31, 2023 · PGR2023-00017 · APJ Zhenyu Yang · PGR · Institution
Instituted PGR on claims 1–10 and all asserted grounds because the Board found it more likely than not that Tobler anticipates and renders obvious at least claim 1.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We review the Petition under 35 U.S.C. § 324, which provides that a post-grant review may not be instituted unless “it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” 35 U.S.C. § 324(a). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 324(a). Accordingly, we institute a post-grant review of all challenged claims based on all grounds raised in the Petition. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); PTAB Consolidated Trial Practice Guide (“Practice Guide”),1 5–6 (Nov. 2019).” slip op. at 2
- Other 314aInstitution denied discretionary otherDenied
“We disagree. It is unclear which aspect of the Petition that Patent Owner takes issue with. If it is the “multitudinous grounds” presented in the Petition, Patent Owner points to no authority that permits us to deny institution merely because a petition presents numerous grounds. In any event, on the facts of this case, we do not view eight grounds asserted in the Petition to be excessive.6 To the extent Patent Owner urges that we should deny institution because Petitioner’s grounds are “futil[e],” we understand that to be an argument on the merits, and not related to our discretion. See Prelim. 6 The Petition presents five grounds. See generally Pet. We agree with Patent Owner, however, the ground based on Tobler, in fact, encompasses three grounds, and the ground based on De Oliveira, in fact, encompasses two grounds. See Prelim. Resp. 2. Resp. 45. As explained below, we find Petitioner has established that it is more likely than not that claims 1–10 of the ’727 patent are unpatentable over Tobler. See infra Section II.D.2. Because the grounds based on Tobler apply to all challenged claims,7 at least these grounds are not, as Patent Owner asserts, futile. Thus, we decline to exercise discretion to deny the Petition under § 324(a).” slip op. at 6
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“review, we “may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Our § 325(d) analysis employs a two-prong framework: (1) whether the arguments presented in the petition are the same or substantially the same as those previously presented to the Office; and (2) if so, whether the petitioner has demonstrated a material error by the Office in its prior consideration of those arguments. Advanced Bionics, LLC v. 7 The cases Patent Owner cites do not support its argument on discretionary denial under § 324(a). See Prelim. Resp. 45–46. In those cases, the Board exercised discretion to deny institution because the petitions only met the threshold requirement for institution with regard to a small percentage of the challenged claims. See Chevron Oronite Co. LLC v. Infineum USA L.P., IPR2018-00923, Paper 9, 11 (PTAB Nov. 7, 2018) (stating “instituting a trial with respect to all twenty claims based on evidence and arguments directed to dependent claims 3 and 4 is not an efficient use of the Board’s time and resources”); Deeper, UAB v. Vexilar, Inc., IPR2018-01310, Paper 7, 2 (PTAB Jan. 24, 2019) (denying institution because the petitioner only “demonstrated a reasonable likelihood of prevailing with respect to only two of twenty-three challenged claims as to only one of four asserted grounds of unpatentability”). MED-EL Electromedizinishe Gerӓte GmbH, IPR2019-01469, Paper 6 (“Advanced Bionics”), 8 (PTAB Feb. 13, 2020) (precedential). The parties agree that, during prosecution, the relevant disclosure in Tobler was before the Examiner in U.S. Patent Application Publication 2010/0216640, which was cited in an Information Disclosure Statement (“IDS”). Pet. 12; Prelim. Resp. 46. In other words, the first prong of the Advanced Bionics analysis is satisfied. Thus, we must determine whether Petitioner has shown a material error by the Office. We find Petitioner has met its burden on this issue.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“The parties agree that, for purposes of this Decision, all claim terms should be given their plain and ordinary meaning. Pet. 18; Prelim. Resp. 13. Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to address the construction of any claim term.” slip op. at 9
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 11,445,727 - PTAB · Jul 20, 2023 · IPR2023-00462 · APJ Jamie T Wisz · IPR · Institution
The Board instituted IPR on claims 1–18 because Petitioner showed a reasonable likelihood of prevailing on anticipation by Fraser and obviousness over the asserted combination.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“In evaluating the exercise of discretion to deny institution under Section 325(d), the Board uses the following two-part framework: (1) determining 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, determining whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims. Advanced Bionics, Paper 6 at 8.” slip op. at 15
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), the Board “may not authorize an inter partes review to be instituted unless . . . the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” After considering the Petition, the Preliminary Response, the Reply, the Sur-reply, and the evidence of record, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing with respect to at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of claims 1–18 of the ’992 patent, based on all of the grounds identified in the Petition. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1354, 1359–60 (2018); 37 C.F.R. § 42.108(a) (“When instituting post-grant review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts that a person of ordinary skill in the art (“POSA”) at the time of the invention “would have had a Ph.D. in pharmaceutical sciences or a similar field, with at least several years of experience in the development, manufacture and characterization of formulations of therapeutic proteins, including, for example, fusion proteins or antibodies.” Pet. 30 (citing Ex. 1002 ¶¶ 39–43). Petitioner further asserts that the POSA “would have understood how to combine proteins with compatible excipients such as surfactants, stabilizers, salts and buffers of various pH values, and how to adjust these combinations in order to optimize their stability in liquid or solid form.” Id. at 30–31. Petitioner asserts that the Because Fraser uses the term “VEGF TrapR1R2” (Ex. 1009, 1115), we use the same nomenclature in this Decision. POSA would have been able to assess stability and compatibility by using “state-of-the-art analytical methods, such as SEC.” Id. at 31. Patent Owner does not contest the characterization offered by Petitioner. See Prelim. Resp. 16. For purposes of this Decision, we adopt Petitioner’s characterization because it is consistent with the level of skill in the art at the time of the invention as reflected by the ’992 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 21
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner proposes claim construction for three terms under their plain and ordinary meaning. See Pet. 41–42. First, Petitioner asserts that the “POSA would have understood that the term ‘native’ in the phrase ‘native conformation’ in claims 1, 2, 10 and 11 refers to the fully intact and functional conformation of the protein.” Id. at 42 (citing Ex. 1002 ¶ 22). Second, Petitioner asserts that the “POSA would have understood the term ‘vial’ in claims 1–9 to refer to a small closed or closable vessel, especially for liquids.” Id. (citing Ex. 1031; Ex. 1002 ¶¶ 23, 190). Third, Petitioner asserts that the “[t]he POSA would have understood the term ‘multimerizing component’ in claims 1 and 10 to refer to a protein moiety that joins two or more protein domains together to form a multimer, such as a dimer or trimer.” Id. (citing Ex. 1002 ¶ 24). Patent Owner does not challenge Petitioner’s proposed claim constructions. Prelim. Resp. 16. For purposes of this Decision, however, we determine that no claim terms require express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 22
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,464,992
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.