• Valeo North America, Inc. / Valeo S.A. et al. v. Magna Electronics Inc.All claims unpatentable
  PTAB · Dec 22, 2016 · IPR2015-01410 · APJ Justin T Arbes · IPR · Final written decision

  Claims 1, 3–12, 14, 15, 17, 19–52, 54–67, 69–79, and 81–86 are unpatentable under § 103(a) over the combinations listed in the Order.

  RulingsFinal written decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted

    “On December 28, 2015, we instituted an inter partes review of claims 1, 3–12, 14, 15, 17, 19–52, 54–67, 69–79, and 81–86 on 17 grounds of unpatentability and consolidated Case IPR2015-01414 with Case IPR2015-01410 (Paper 7, “Dec. on Inst.”). Patent Owner Magna Electronics Inc. filed a Patent Owner Response (Paper 14, “PO Resp.”), and Petitioner filed a Reply (Paper 17, “Reply”). The parties did not request oral argument, and no hearing was held. See Paper 22.” slip op. at 2

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artDecided for petitioner

    “Patent Owner’s arguments are not persuasive for three reasons. First, as explained above, to establish an earlier constructive reduction to practice, Patent Owner must show that the ’527 application provides sufficient written description support for the challenged claims. Patent Owner states that “each limitation of [the set of claims listed above] is supported in the ’935 patent disclosure,” but includes no substantive arguments in its Response explaining why. See id. Rather, Patent Owner cites 46 paragraphs of Dr. Etienne-Cummings’s declaration and a “Constructive Reduction to Practice Chart” spanning 43 pages. Id. (citing Ex. 2001; Ex. 2004 ¶¶ 54–99). Any arguments contained in these materials cannot be incorporated by reference into the Response. See 37 C.F.R. § 42.6(a)(3) (“Arguments must not be incorporated by reference from one document into another document.”).12 Consequently, we do not consider information presented in the declaration or claim chart but not discussed sufficiently in the Response. Second, even if Dr. Etienne-Cummings’s analysis and the claim chart are considered, they are not sufficient. The claim chart provides only block 12 See also Paper 8, 3 (“The patent owner is cautioned that any arguments for patentability not raised in the response will be deemed waived.”); Apple, Inc. v. Ameranth, Inc., Case CBM2014-00013, 8 (PTAB Mar. 20, 2015) (Paper 37) (“Arguments that are not developed and presented in the Patent Owner Response, itself, are not entitled to consideration.”), reversed-in-part on other grounds, No. 2015-1703, -- F.3d --, 2016 WL 6958650 (Fed. Cir. Nov. 29, 2016); Cisco Sys., Inc. v. C-Cation Techs., LLC, Case IPR2014-00454, 7–10 (PTAB Aug. 29, 2014) (Paper 12) (informative) (noting that “[o]ne purpose of the prohibition against incorporation by reference is to eliminate abuses” of the page limits established for the parties’ substantive papers, and that citing “large portions of another document, without sufficient explanation of those portions, amounts to incorporation by reference”). quotes and figures from the ’935 patent,13 but does not explain in any detail why they provide support for the various limitations of the challenged claims. See Ex. 2001. Likewise, the majority of Dr. Etienne-Cummings’s declaration merely states that “the features of [the respective claim] are disclosed” at the block-quoted portions of the ’935 patent, without explanation. See, e.g., Ex. 2004 ¶¶ 56–61, 64, 65, 67–74, 76–99. Third, we agree with Petitioner that the ’935 patent does not provide sufficient written description support for the independent claims of the ’724 patent (claims 1, 49, 65, and 78), each of which recites that the “synthesized image is displayed by a single display screen of a reconfigurable display device that is viewable by a driver of the equipped vehicle when normally operating the equipped vehicle.” See Reply 13–15. As explained above, we interpret “reconfigurable display” to mean a display in which a portion of the display upon which the driver views the synthesized image is used as a high-information content display to selectively display various types of auxiliary information. See supra Section II.A.4. Patent Owner cites various excerpts from the ’935 patent describing display 20, but these portions do not call the display device “reconfigurable” or disclose that it is used to selectively display information. See, e.g., Ex. 2001, 5–6 (citing Ex. 2002, col. 3, l. 61–col. 4, l. 5, col. 5, ll. 48–50, col. 6, ll. 5–12, 22–39); Ex. 2004 ¶ 56. Indeed, the ’724 patent Specification 13 It is unclear why Patent Owner attempts to map the disclosure of the ’935 patent, rather than the ’527 application, to the challenged claims. The ’935 patent issued on September 23, 1997 (after Yamamoto published), from the ’527 application filed on May 22, 1995 (before Yamamoto published). Patent Owner does not provide a copy of the ’527 application in the record to show that the written description is the same as that of the issued ’935 patent.” slip op. at 26

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable

    “parallax or require that the problem of parallax be solved for the synthesized image. See supra Sections II.A.2–3. Rather, we interpret “synthesized image is generated without duplication of objects” to mean the synthesized image is generated with minimal multiple exposure of objects appearing in the overlap zones, and interpret “synthesized image approximates a view as would be seen by a virtual camera at a single location exterior of the equipped vehicle” to mean the synthesized image is a nearly exact representation of what would be seen by a virtual camera at a single location exterior of the vehicle. Id. Thus, the claims allow for a “minimal” level of multiple exposure and only require a “nearly exact” representation of what the virtual camera would see. We are not persuaded that any parallax effects that might remain when the pattern recognition techniques of Mitsubishi are used in Yamamoto’s system, as Petitioner asserts, would cause more than “minimal” multiple exposure or prevent the resulting image from being a “nearly exact” representation. See Ex. 1020 ¶ 110; Ex. 1066 ¶ 25. Moreover, even if the resulting image in the combined system would suffer from some parallax effects, we do not see how that contradicts Petitioner’s asserted reason for why a person of ordinary skill in the art would have modified Yamamoto’s system, or why parallax concerns would have outweighed the advantage of improved image processing, such that an ordinarily skilled artisan would have abandoned the three camera arrangement of Yamamoto. See Reply 15–17; Winner Int’l Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n.8 (Fed. Cir. 2000) (“The fact that the motivating benefit comes at the expense of another benefit, however, should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another. Instead, the benefits, both lost and gained, should be weighed against one another.”). In that respect, we find Dr. Wolberg’s analysis of how and why a person of ordinary skill in the art would have combined the references’ teachings compelling. See Ex. 1020 ¶¶ 101–15; Ex. 1066 ¶¶ 22–37.” slip op. at 32

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “public accessibility. PO Resp. 17–21. Based on all of the evidence of record,18 however, we are persuaded that Wang was disseminated or otherwise made available prior to May 22, 1996, to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence could have located it. Most probative are the Library of Congress certification and Linda Hall Library documentation, which show that Wang was catalogued and readily available through these libraries. See Exs. 1046, 1060. Mr. Grenier further testifies that copies of the article were made available to attendees of the EURO ASIC ’91 conference, which was an IEEE academic conference pertaining to ASICs. See Ex. 1039; Ex. 1055; Ex. 1060, 2–13 (stating that the conference “includes reports on ASIC design experiences, advances in design methods and tools, and on the evolution of ASIC technology,” and is “the definitive place . . . for the academic community to exchange ideas”; listing numerous papers to be 18 We are persuaded that all of Petitioner’s evidence should be considered, including the evidence introduced with the Reply, under 37 C.F.R. § 42.23(b). Further, during a conference call with the parties on May 26, 2016, Patent Owner sought authorization to file a motion to “strike” Petitioner’s new evidence and portions of Petitioner’s Reply. See Paper 20. We determined that a motion to strike was not appropriate at that time, but stated that “[s]hould either party request a hearing in this proceeding, . . . the parties may address the propriety of the exhibits and Petitioner’s Reply during oral argument. If the parties choose not to request a hearing, Patent Owner may request another conference call and we will determine whether additional briefing or any other action may be appropriate at that time.” Id. at 3; Ex. 1071, 20:14–22:18. Patent Owner did not request oral argument, and did not request another conference call to address the issue. presented relating to, for example, digital signal processing ASICs, chip architecture, and graphic application and image processing ASICs). Given the level of ordinary skill in the art of the ’724 patent set forth above, see supra Section II.B, we are persuaded that the EURO ASIC ’91 conference is the type of conference that ordinarily skilled artisans would have been interested in and likely attended. The dates and documentation for the conference also are consistent with the other submitted evidence, including the copyright notation of Wang itself, which states in part “© 1991 IEEE.” See Ex. 1009, 1. Finally, as Petitioner correctly points out, the first article cited by Dr. Wolberg shows that Wang in fact was accessed by some other individuals working in the field of image sensors. See Reply 12; Ex. 1040. Based on the record presented, we are persuaded that Wang is a prior art printed publication under 35 U.S.C. § 102(b).” slip op. at 45

  Patent outcomesUS 8,643,724 unpatentable
  § 102 anticipation§ 103 obviousnesscites Phillips · KSR
  Patents in suitUS 8,643,724
• Samsung Electronics Co. Ltd. / Samsung Electronics America, Inc. et al. v. Ixi IP, LLCAll claims unpatentable
  PTAB · Dec 21, 2016 · IPR2015-01446 · APJ John A Hudalla · IPR · Final written decision

  Claims 1, 2, 6, 7, 9, 10, 12–16, 21–24, 26–28, and 30 are unpatentable under § 103(a) over Marchand and Sears, or Marchand, Sears, and Lee.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “According to Petitioner, a person of ordinary skill in the art relevant to the ’648 patent would have had a Master of Science Degree in electrical engineering, computer engineering, or computer science or a bachelor’s degree in electrical engineering, computer engineering, or computer science and two or more years of experience in communication and networking systems. Pet. 7. Petitioner’s contention is supported by the testimony of Dr. Kiaei, who bases his testimony on his “experience working in industry and academia, with undergraduate and postgraduate students, with colleagues from academia, and with engineers practicing in industry.” Ex. 1014 ¶¶ 15– 16. IXI does not dispute Petitioner’s definition of the level of ordinary skill in the art, and, in fact, IXI applies it in IXI’s Patent Owner Response. PO Resp. 8; see also Ex. 2501 ¶ 16 (IXI’s declarant, Dr. Mandayam, applying same definition). Accordingly, we apply Petitioner’s definition of the level of ordinary skill in the art for purposes of this Decision. We further observe that Petitioner’s proposed definition comports with the qualifications a person would need to understand and implement the teachings of the ’648 patent and the prior art of record.” slip op. at 8

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “Petitioner also cites Sears’s description that device information can be “provided by a device or user during a request for . . . application download.” Pet. 36 (quoting Ex. 1015 ¶ 41) (emphasis added). Petitioner additionally cites Sears’s description of software that is downloaded “based on a user profile sent at the time of search.” Pet. Reply 7 (quoting Ex. 1015 ¶ 42). Contrary to IXI’s arguments, these citations establish that Sears is not limited to providing device information in one transaction and then downloading software in a separate transaction. Rather, we are persuaded by Petitioner’s analysis that an ordinarily skilled artisan would have understood Sears as also teaching contemporaneous downloading and sending of device information. See Ex. 1014 ¶¶ 62–63. Thus, Petitioner establishes that the combination of Marchand and Sears teaches every limitation of claim 1.” slip op. at 15

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

    “IXI also characterizes Petitioner’s alleged motivation to combine Marchand and Sears as being a “hindsight-fueled, juxtaposition of discrete elements of the references.” PO Resp. 27. IXI argues that Petitioner’s alleged motivation “is based entirely on maintaining the benefits (or not ‘negating the benefits of’[)] of each individual system after making the alleged combination.” PO Resp. 26 (citing Pet. 15–16). We do not find Petitioner’s alleged motivation to be flawed, however. Supported by the testimony of Dr. Kiaei, Petitioner provides an extensive analysis that turns on an ordinarily skilled artisan being motivated to add “Sears’ techniques for optimized downloading of applications” to Marchand. See Pet. 15 (citing Ex. 1014 ¶¶ 31–34). Petitioner’s mention of “retain[ing] the benefits” of Marchand simply underscores that Sears’s server and optimized application downloading functionality augment and provide further benefits to Marchand’s piconet and its use of a gateway mobile phone to connect to a cellular IP network. Id. at 17–18 (citing Ex. 1014 ¶ 37). Petitioner’s combination also is rooted in the common teachings mentioned above. Thus, Petitioner establishes that an ordinarily skilled artisan would have recognized that Sears’s technique would also improve similar devices in the same way; as such, using Sears’s technique in this way “is obvious unless its actual application is beyond his or her skill.” KSR, 550 U.S. at 417. The relatively high level of skill ascribed to an ordinary artisan—namely, a Master of Science degree in engineering (see supra § II.A.2.)—suggests that applying Sears’s techniques to Marchand would have been well within the skill of an ordinarily skilled artisan. For these reasons, Petitioner has established that a person of ordinary skill in the art would have had reason to combine the teachings of Marchand and Sears to achieve the method recited in claim 1.” slip op. at 17

  • Obviousness (§103) › Objective indicia / secondary considerationsOther

    “c. Secondary Considerations of Nonobviousness IXI did not put forth any evidence of secondary considerations of nonobviousness.” slip op. at 18

  Patent outcomesUS 7,016,648 unpatentable
  § 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,016,648
• Samsung Electronics Co., Ltd. / Samsung Electronics America, Inc. et al. v. Ixi IP, LLCAll claims unpatentable
  PTAB · Dec 21, 2016 · IPR2015-01443 · APJ Kristina M Kalan · IPR · Final written decision

  Claims 1, 4, 5, 7–9, 12, 14–16, and 23–24 are unpatentable under § 103 over the instituted combinations of Marchand, Router Plugins, and the applicable additional references.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedOther

    “For the purpose of this Decision, we accept Petitioner’s undisputed contention that a person of ordinary skill in the art as of the critical date would have had a Master’s of Science Degree in an academic area emphasizing electrical engineering, computer engineering, or computer science (or a similar technical Master’s Degree, or higher degree) with a concentration in communication and networking systems or, alternatively, a Bachelor Degree (or higher degree) in an academic area emphasizing electrical engineering, computer engineering, or computer science and having two or more years of experience in communication and networking systems. Ex. 1003 at 15. Additional education in a relevant field, such as computer science, computer engineering, or electrical engineering, or industry experience may compensate for a deficit in one of the other aspects of the requirements stated above. Pet. 9–10. Patent Owner applied Petitioner’s definition in its Patent Owner Response. PO Resp. 10–11. The level of ordinary skill in the art is further” slip op. at 8

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “the broadest reasonable construction in light of the specification of the patent in which they appear. See Cuozzo Speed Techs., LLC v. Lee, 136 S.Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard); 37 C.F.R. § 42.100(b). Under that standard, and absent any special definitions, we give claim terms their ordinary and customary meaning, as would be understood by one of ordinary skill in the art at the time of the invention. See In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definitions for claim terms must be set forth with reasonable clarity, deliberateness, and precision. See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). Only those terms which are in controversy need to be construed, and only to the extent necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). In our Decision on Institution, we determined that the claim 1 phrase “software component . . . loaded . . . from the one or more devices connected to said one or more cellular networks” needed no express construction. Dec. 7–8. Patent Owner, in its Response, agrees that “a person of ordinary skill in the art would have understood this recitation without an explicit construction.” PO Resp. 11. We see no reason to modify our position in light of the record developed at trial. No other claim terms have been presented to us for construction, and we determine that no other claim terms require express construction. B. Principles of Law” slip op. at 6

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundUnpatentable

    “We are persuaded by Petitioner’s arguments in this regard. We understand Petitioner as premising the combinability of Marchand and Router Plugins on the routing of IP packets. Pet. 14 (Marchand’s “mobile gateway 33 performs routing for IP packets”), 23 (“Marchand discloses a mobile phone gateway 33 that routes IP packets between a local area network and an external cellular network . . . .”); Reply 3. Petitioner relies on Router Plugins’ “plugin-based routing software” to be “implemented in Marchand’s mobile phone gateway 33 to implement various types of router functionality, such as routing of IP packets and IP address translation.” Pet. 24. Indeed, Dr. Mandayam agrees that routing of IP packets is done by Marchand, and is done at a network layer of the protocol stack. Reply 3–4 (citing Ex. 1016, 21:21–22:2, 160:16–19; Ex. 2201 ¶¶ 34, 35). Dr. Mandayam also agrees that Router Plugins performs routing of IP packets, and that routing of IP packets occurs at a network layer of the protocol stack. Id. at 5–6 (citing Ex. 1016, 145:15–24, 21:21–22:2). We further agree with Petitioner’s contention that, even though the Router Plugins routing framework fits within an operating system kernel, “Router Plugins does not describe routing IP packets at the operating system layer,” but rather, performs routing of IP packets at a network layer of the protocol stack. Id. at 4–5 (citing Ex. 1006, 229 col. 2, 231 col. 2, Fig. 1). We credit Dr. Kiaei’s testimony that one of ordinary skill in the art, understanding that both “Marchand and Router Plugins describe devices that utilize software to route IP packets and perform network address translation,” would have been motivated to make Marchand’s IP routing “more ‘flexible and modular’ by using the plugin-based router software of Router Plugins.” Ex. 1003 ¶ 55. The enhanced routing of IP packets at the network layer, as demonstrated by Router Plugins, would have led one of ordinary skill in the art to consider the inclusion of Router Plugins’ technology to better the IP routing of Marchand, which also takes place at the network layer.” slip op. at 14

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “We have the discretion to determine the appropriate weight to be accorded to the evidence presented, including opinion testimony, based on the disclosure of the underlying facts or data upon which the opinion is based. See, e.g., Yorkey v. Diab, 601 F.3d 1279, 1284 (Fed. Cir. 2010) (holding the Board has discretion to credit one witness’s testimony over another “unless no reasonable trier of fact could have done so”). We are not persuaded by Patent Owner’s arguments that Dr. Kiaei’s testimony as a whole should be given “little weight, if any.” We have considered Patent Owner’s sub-piconet theory, and we determine that it would not have limited an ordinarily skilled artisan’s understanding of Marchand. Thus, we accord an appropriate weight to Dr. Kiaei’s testimony as indicated in this Decision and for the reasons articulated in this Decision. F. Motion to Exclude” slip op. at 34

  Patent outcomesUS 7,295,532 unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 7,295,532
• Mylan Pharmaceuticals, Inc. / Amneal Pharmaceuticals LLC v. Yeda Research And Development Co. Ltd.Rehearing granted
  PTAB · Dec 2, 2016 · IPR2015-01981 · APJ Sheridan K Snedden · IPR · Rehearing

  Patent Owner’s rehearing request was granted as to the Pinchasi–Flechter combination analysis; rehearing was denied on the remaining issues, and a modified final written decision was entered.

  RulingsRehearing decision

  • RehearingRehearing, grantedRehearing, deniedGranted in part

    “found instead that the data taught that less-frequent-than-daily administration would have been more tolerable than daily administration.” Reh’g Req. 6 (citing Dec. 29). Upon review of the Decision, we agree that the analysis in the cited portion of our Decision does not conflate efficacy with tolerability. See Final Dec. 32–33. Accordingly, we grant this portion of Patent Owner’s Request for Reconsideration and retract our reliance on the efficacy data of Flechter in Section II.C.5 of the Decision as the basis for rejecting Patent Owner’s argument regarding the lack of motivation to combine Pinchasi and Flechter. We concurrently issue a modified Final Written Decision (Paper 90) to reflect this change.” slip op. at 3

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

    “As explained above, we were not persuaded that the prior art suggested decreased tolerability. Indeed, in light of the prior art references each stating that the dosage regimens were well tolerated, we were persuaded that a person of ordinary skill in the art would have had a reason to combine the cited references to reach the claimed dosing regimen with a reasonable expectation of success.” slip op. at 7

  • Obviousness (§103) › Objective indicia / secondary considerationsDecided for petitioner

    “Finally, Patent Owner asserts that the Board overlooked evidence regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 12–13. Patent Owner also states that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 24) is also incorrect.” Id. at 14. First, we did not state that Patent Owner failed to provide any evidence 5 Khan et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in Relapsing-Remitting Multiple Sclerosis, 14 MULTIPLE SCLEROSIS S296 (2008) (Ex. 1010) (“Khan 2008”). 6 Caon et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in RRMS, 72 NEUROLOGY A317 (Mar. 17, 2009) (Ex. 1011) (“Caon 2009”). of improved tolerability—we stated that Patent Owner provided “insufficient evidence of record showing any unexpected results between the claimed requirement of three doses per week compared to dosing every other day.” Dec. 24 (emphasis added). As explained above, we did not find Patent Owner’s characterizations of the prior art, including Cohen, persuasive.” slip op. at 7

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “We note—and agree with—Dr. Ziemssen’s testimony that a person of ordinary skill in the art “generally would not view this type of cross-study comparison between different study populations as a basis for drawing any comparative conclusions.” Ex. 2135 ¶ 87. We are therefore unpersuaded by his ad hoc comparison of Flechter’s data with that of Meiner. Id. ¶ 89. Instead, we find more credible Flechter’s conclusion that alternate-day administration of glatiramer acetate was “well tolerated, comparing favorably with the effects of daily injections of Copolymer 1 in patients with relapsing MS.” Ex. 1008, 1; see also id. at 5 (“The results of this trial suggest that alternate-day treatment with Copolymer 1 is safe, well tolerated, and probably as effective as daily Copolymer 1 in reducing relapse rate and slowing neurologic deterioration.”).” slip op. at 4

  § 103 obviousness
  Patents in suitUS 8,969,302
• Mylan Pharmaceuticals Inc. / Amneal Pharmaceuticals LLC v. Yeda Research & Development Co. Ltd.Rehearing granted
  PTAB · Dec 2, 2016 · IPR2015-00643 · APJ Zhenyu Yang · IPR · Rehearing

  The Board granted rehearing on the Pinchasi–Flechter motivation issue, denied rehearing on the remaining issues, vacated the prior Final Written Decision, and entered a modified decision concurrently.

  RulingsRehearing decision

  • RehearingRehearing, grantedRehearing, deniedGranted in part

    “§ 42.71 (d), which requires the party requesting rehearing to “specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.”” slip op. at 2

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundMixed

    “Patent Owner first asserts that we “misconstrued data in Flechter illustrating that alternate day dosing was as effective as daily dosing and found instead that the data taught that less-frequent-than-daily administration would have been more tolerable than daily administration.” Reh’g Req. 7 (citing Dec. 32). Upon review of the Decision, we agree. See Dec. 32–33. Accordingly, we grant this portion of Patent Owner’s Request for Reconsideration and retract our reliance on the efficacy data of Flechter in Section II.F of the Decision as the basis for rejecting Patent Owner’s argument regarding the lack of motivation to combine Pinchasi and Flechter. We concurrently issue a modified Final Written Decision (Paper 90) to reflect this change.” slip op. at 3

  • Obviousness (§103) › Objective indicia / secondary considerationsNot shown unpatentable

    “regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 14–15. Patent Owner argues that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 26) is also incorrect.” Id. at 14. We did not state that Patent Owner failed to provide any evidence of improved tolerability—we stated that Patent Owner provided “insufficient” slip op. at 8

  • Expert testimonyPatent owner expert discountedDecided for patent owner

    “Dr. Ziemssen, however, qualifies this comparison and explains that a person of ordinary skill in the art “generally would not view this type of cross-study comparison between different study populations as a basis for drawing any comparative conclusions.” Ex. 2135 ¶ 87. We agree. As a result, we are unpersuaded by the conclusion drawn from the ad hoc comparison of the data in Flechter with those in Meiner. This is especially so in view of Flechter’s conclusion that alternate-day administration of glatiramer acetate was “well tolerated, comparing favorably with the effects of daily injections of Copolymer 1 in patients with relapsing MS.” Ex. 1008, 1; see also id. at 5 (“The results of this trial suggest that alternateday treatment with Copolymer 1 is safe, well tolerated, and probably as effective as daily Copolymer 1 in reducing relapse rate and slowing neurologic deterioration.”).” slip op. at 4

  § 103 obviousness
  Patents in suitUS 8,232,250
• Mylan Pharmaceuticals, Inc. / Amneal Pharmaceuticals LLC v. Yeda Research And Development Co. Ltd.Rehearing granted
  PTAB · Dec 2, 2016 · IPR2015-00830 · APJ Sheridan K Snedden · IPR · Rehearing

  The Board granted rehearing on the Pinchasi–Flechter combination, retracting reliance on Flechter’s efficacy data, and denied rehearing on the remaining issues.

  RulingsRehearing decision

  • RehearingRehearing, grantedRehearing, deniedGranted in part

    “STANDARD OF REVIEW The party requesting rehearing has the burden to show that the decision should be modified. Under 37 C.F.R. § 42.71(d), the request for rehearing must identify, specifically, all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” slip op. at 2

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

    “We note—and agree with—Dr. Ziemssen’s testimony that a person of ordinary skill in the art “generally would not view this type of cross-study comparison between different study populations as a basis for drawing any comparative conclusions.” Ex. 2135 ¶ 87. We are therefore unpersuaded by his ad hoc comparison of Flechter’s data with that of Meiner. Id. ¶ 89. Instead, we find more credible Flechter’s conclusion that alternate-day administration of glatiramer acetate was “well tolerated, comparing favorably with the effects of daily injections of Copolymer 1 in patients with relapsing MS.” Ex. 1008, 1; see also id. at 5 (“The results of this trial suggest that alternate-day treatment with Copolymer 1 is safe, well tolerated, and probably as effective as daily Copolymer 1 in reducing relapse rate and slowing neurologic deterioration.”). Accordingly, we are not persuaded that a person of ordinary skill in the art considering combining a higher dose of GA with Flechter’s alternateday dosing schedule would conclude that such a regimen would likely exacerbate the frequency of injection site reactions, as Patent Owner asserts. See PO Resp. 36.” slip op. at 4

  • Expert testimonyPatent owner expert discountedDecided for petitioner

    “Flechter suggests that less frequent injections were less tolerable than daily injections reported in Meiner.3 In particular, Patent Owner points us to the Patent Owner Response, which compares the alternate-day data in Flechter with the daily administration data of Meiner. Reh’g Req. 7–8 (citing PO Resp. 35–36). Although Flechter itself did not compare the data, Patent Owner and its declarant, Dr. Tjalf Ziemssen, M.D., Ph.D., compare Flechter’s data reporting adverse events in its patients with Meiner’s data reporting adverse events in a different cohort of patients. PO Resp. 35–36; Ex. 2135 ¶ 89. From that comparison, Patent Owner argues that Flechter’s data allegedly teaches that alternate-day administration is less tolerable than daily administration. Reh’g Req. 8.” slip op. at 3

  • Obviousness (§103) › Objective indicia / secondary considerationsDecided for petitioner

    “Finally, Patent Owner asserts that the Board overlooked evidence regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 12–13. Patent Owner also states that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 24) is also incorrect.” Id. at 14. First, we did not state that Patent Owner failed to provide any evidence 5 Khan et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in Relapsing-Remitting Multiple Sclerosis, 14 MULTIPLE SCLEROSIS S296 (2008) (Ex. 1010) (“Khan 2008”). 6 Caon et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in RRMS, 72 NEUROLOGY A317 (Mar. 17, 2009) (Ex. 1011) (“Caon 2009”). of improved tolerability—we stated that Patent Owner provided “insufficient evidence of record showing any unexpected results between the claimed requirement of three doses per week compared to dosing every other day.” Dec. 24 (emphasis added). As explained above, we did not find Patent Owner’s characterizations of the prior art, including Cohen, persuasive.” slip op. at 7

  § 103 obviousness
  Patents in suitUS 8,969,302
• Mylan Pharmaceuticals Inc. / Amneal Pharmaceuticals LLC v. Yeda Research & Development Co. Ltd.Rehearing granted
  PTAB · Dec 2, 2016 · IPR2015-01976 · APJ Zhenyu Yang · IPR · Rehearing

  On rehearing, the Board modified its decision and held claims 1–20 unpatentable as obvious over Pinchasi with the 1996 SBOA and over Pinchasi with Flechter.

  RulingsRehearing decision

  • RehearingGranted in part

    “we entered a Final Written Decision pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73. Patent Owner filed a request for rehearing of our decision. Paper 87. In a concurrently issued Order, we grant-in-part Patent Owner’s request and vacate our original decision. Paper 89. We hereby issue this modified Final Written Decision.” slip op. at 2

  • Skill levelSkill level patent owner adoptedDecided for patent owner

    “in the art. Petitioner contends that a person of ordinary skill in the art would have had (1) several years of experience in the pharmaceutical industry or in practicing medicine; (2) experience with the administration or formulation of therapeutic agents, dosing schedules and frequencies, and drug developmental study and design; and (3) a Ph.D. in pharmacology or an M.D. with experience in clinical pharmacology. Pet. 13. In its Preliminary Response, Patent Owner asserted that a skilled artisan would have had knowledge of, and experience with, both MS and GA. Prelim. Resp. 33–34. In the Decision to Institute, we agreed with Patent Owner. Dec. 9. We noted that Dr. Green, one of Petitioner’s declarants, states that a person of ordinary skill in the art would have had “direct experience administering therapeutic agents for the treatment of MS, as well as familiarity with the dosing schedules and frequencies of the different therapeutic agents available for MS treatment.” Id. (citing Ex. 1004 ¶ 27). During trial, neither party contests our findings of the level of a person of ordinary skill in the art. Upon considering the full record, we see no reason to deviate from our prior determination. Thus, we reiterate that in addition to the qualifications specified by Petitioner, a person of ordinary skill in the art would also have experience treating MS with GA.” slip op. at 8

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner

    “As an initial matter, we note that, in its Preliminary Response, Patent Owner challenged the status of the 1996 SBOA as a printed publication under 35 U.S.C. § 102(b). Prelim. Resp. 47–48. In the Decision to Institute, we determined that, based on the record available then, the 1996 SBOA constitutes prior art under § 102(b). Dec. 12–13. In its Response, Patent Owner does not dispute this finding. Having considered the complete record developed at trial, we reiterate that Petitioner has presented sufficient evidence (see Ex. 1007) to show that the 1996 SBOA was publicly accessible at least by July 17, 2007, more than one year before the earliest possible priority date of the ’250 patent (i.e., August 20, 2008). See Dec. 12–13. Thus, the 1996 SBOA constitutes prior art under § 102(b).” slip op. at 9

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

    “Upon considering the evidence as a whole, we also find that an ordinary artisan would have been motivated to administer GA three times over a period of seven days to increase patient compliance. We note again that Pinchasi teaches administering 40 mg GA every other day, which equates to seven doses over two weeks. Ex. 1005, 9. Thus, the difference between the challenged claims (three doses over a period of seven days, or six doses over two weeks) and the prior art is one less injection every two weeks. Dr. Green testifies that it was a well-known principle that decreasing the frequency of injections would have a positive impact on patients to stay on course with treatment. Ex. 1004 ¶ 101. The desirability of less frequent injections is supported by the 1996 SBOA, in which the reviewer recommended that Teva evaluate the necessity of daily injections as opposed to more infrequent intermittent administration of Copaxone®. Ex. 1007, 252.” slip op. at 13

  § 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,232,250
• Mylan Pharmaceuticals Inc. / Amneal Pharmaceuticals LLC v. Yeda Research & Development Co. Ltd.Rehearing granted
  PTAB · Dec 2, 2016 · IPR2015-01976 · APJ Zhenyu Yang · IPR · Rehearing

  The Board granted rehearing on the Pinchasi–Flechter combination, denied rehearing on the remaining issues, vacated the prior final written decision, and entered a modified decision concurrently.

  RulingsRehearing decision

  • RehearingRehearing, grantedRehearing, deniedGranted in part

    “§ 42.71 (d), which requires the party requesting rehearing to “specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.”” slip op. at 2

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundMixed

    “person of ordinary skill in the art “generally would not view this type of cross-study comparison between different study populations as a basis for drawing any comparative conclusions.” Ex. 2135 ¶ 87. We agree. As a result, we are unpersuaded by the conclusion drawn from the ad hoc comparison of the data in Flechter with those in Meiner. This is especially so in view of Flechter’s conclusion that alternate-day administration of glatiramer acetate was “well tolerated, comparing favorably with the effects of daily injections of Copolymer 1 in patients with relapsing MS.” Ex. 1008, 1; see also id. at 5 (“The results of this trial suggest that alternateday treatment with Copolymer 1 is safe, well tolerated, and probably as effective as daily Copolymer 1 in reducing relapse rate and slowing neurologic deterioration.”). Accordingly, we are not persuaded that a person of ordinary skill in the art considering combining a higher dose of GA with the alternate-day dosing schedule in Flechter would, as Patent Owner asserts, conclude that 5 Meiner et al., Copolymer 1 in Relapsing-Remitting Multiple Sclerosis: a Multi-Centre Trial, in Frontiers in Multiple Sclerosis: Clinical Research and Therapy (Abramsky et al. eds., 1997) (Ex. 1009). such a regimen would likely exacerbate the frequency of injection site reactions. See PO Resp. 36.” slip op. at 4

  • Obviousness (§103) › Objective indicia / secondary considerationsNot shown unpatentable

    “regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 14–15. Patent Owner argues that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 26) is also incorrect.” Id. at 14. We did not state that Patent Owner failed to provide any evidence of improved tolerability—we stated that Patent Owner provided “insufficient 8 Khan et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in Relapsing-Remitting Multiple Sclerosis, 14 MULTIPLE SCLEROSIS S296 (2008) (Ex. 1010). 9 Caon et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in RRMS, 72 NEUROLOGY A317 (Mar. 17, 2009) (Ex. 1011). evidence of record showing any unexpected benefit between the claimed three-times-weekly as compared to the prior art every-other-day dosing.” Dec. 26 (emphasis added). Substantively, as explained above, we find Patent Owner’s characterizations of the prior art, including Cohen, unpersuasive. As a result, we were not, and remain not, persuaded that the nonobviousness of the challenged claims is supported by evidence of unexpected results.” slip op. at 8

  • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsDecided for petitioner

    “regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 14–15. Patent Owner argues that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 26) is also incorrect.” Id. at 14. We did not state that Patent Owner failed to provide any evidence of improved tolerability—we stated that Patent Owner provided “insufficient 8 Khan et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in Relapsing-Remitting Multiple Sclerosis, 14 MULTIPLE SCLEROSIS S296 (2008) (Ex. 1010). 9 Caon et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in RRMS, 72 NEUROLOGY A317 (Mar. 17, 2009) (Ex. 1011). evidence of record showing any unexpected benefit between the claimed three-times-weekly as compared to the prior art every-other-day dosing.” Dec. 26 (emphasis added). Substantively, as explained above, we find Patent Owner’s characterizations of the prior art, including Cohen, unpersuasive. As a result, we were not, and remain not, persuaded that the nonobviousness of the challenged claims is supported by evidence of unexpected results.” slip op. at 8

  § 103 obviousness
  Patents in suitUS 8,232,250
• Mylan Pharmaceuticals Inc. / Amneal Pharmaceuticals LLC v. Yeda Research & Development Co. Ltd.Rehearing granted
  PTAB · Dec 2, 2016 · IPR2015-01980 · APJ Tina E Hulse · IPR · Rehearing

  The Board granted rehearing on the Pinchasi–Flechter combination issue, denied rehearing on the remaining issues, vacated the original decision, and entered a modified final written decision.

  RulingsRehearing decision

  • RehearingRehearing, grantedRehearing, deniedGranted in part

    “STANDARD OF REVIEW The party requesting rehearing has the burden to show that the decision should be modified. Under 37 C.F.R. § 42.71(d), the request for rehearing must identify, specifically, all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” slip op. at 2

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundDecided for patent owner

    “found instead that the data taught that less-frequent-than-daily administration would have been more tolerable than daily administration.” Reh’g Req. 7 (citing Dec. 25–26). The cited pages 25–26 of our Decision address the misinterpretation of data in Flechter. Dec. 25–26. But, contrary to Patent Owner’s assertion, we do not conflate the efficacy data of Flechter with tolerability. Rather, we find that “we are not persuaded by Patent Owner’s argument that a person of ordinary skill in the art would interpret Flechter as showing that decreasing the dosing frequency would decrease the efficacy of the drug.” Dec. 25–26 (emphasis added). Although the cited portion of our Decision does not conflate efficacy with tolerability, we acknowledge that our Decision regarding the combination of Pinchasi and Flechter does. See Dec. 32–33. Accordingly, we grant Patent Owner’s request for reconsideration as to this portion of our Decision. We, therefore, do not rely on the efficacy data of Flechter in Section II.E.2 of the Final Written Decision as the basis for rejecting Patent Owner’s argument regarding the lack of motivation to combine Pinchasi and Flechter. Nevertheless, we are not persuaded by Patent Owner’s argument that Flechter suggests that less frequent injections were less tolerable than daily injections reported in Meiner.3 In particular, Patent Owner points us to the Patent Owner Response, which compares the alternate-day data in Flechter with the daily administration data of Meiner. Reh’g Req. 7–8 (citing PO Resp. 35–36). Although Flechter itself did not compare the data,” slip op. at 3

  • Expert testimonyPatent owner expert discountedPetitioner expert creditedDecided for petitioner

    “We note—and agree with—Dr. Ziemssen’s testimony that a person of ordinary skill in the art “generally would not view this type of cross-study comparison between different study populations as a basis for drawing any comparative conclusions.” Ex. 2135 ¶ 87. We are therefore unpersuaded by his ad hoc comparison of Flechter’s data with that of Meiner. Id. ¶ 89. Instead, we find more credible Flechter’s conclusion that alternate-day administration of glatiramer acetate was “well tolerated, comparing favorably with the effects of daily injections of Copolymer 1 in patients with relapsing MS.” Ex. 1008, 1; see also id. at 5 (“The results of this trial suggest that alternate-day treatment with Copolymer 1 is safe, well tolerated, and probably as effective as daily Copolymer 1 in reducing relapse rate and slowing neurologic deterioration.”).” slip op. at 4

  • Obviousness (§103) › Objective indicia / secondary considerationsDecided for petitioner

    “regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 14–15. Patent Owner also states that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 26–27) is also incorrect.” Id. at 14. First, we did not state that Patent Owner failed to provide any 8 Khan et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in Relapsing-Remitting Multiple Sclerosis, 14 MULTIPLE SCLEROSIS S296 (2008) (Ex. 1010) (“Khan 2008”). 9 Caon et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in RRMS, 72 NEUROLOGY A317 (Mar. 17, 2009) (Ex. 1011) (“Caon 2009”). evidence of improved tolerability—we stated that Patent Owner provided “insufficient evidence of record showing any unexpected results between the claimed requirement of three doses per week compared to dosing every other day.” Dec. 26–27 (emphasis added). As explained above, we did not find Patent Owner’s characterizations of the prior art, including Cohen, persuasive.” slip op. at 8

  § 103 obviousness
  Patents in suitUS 8,399,413
• Mylan Pharmaceuticals Inc. / Amneal Pharmaceuticals LLC v. Yeda Research & Development Co. Ltd.Rehearing granted
  PTAB · Dec 2, 2016 · IPR2015-00644 · APJ Tina E Hulse · IPR · Rehearing

  The Board granted rehearing on the Pinchasi–Flechter combination issue, denied rehearing on the remaining issues, and vacated the original final written decision.

  RulingsRehearing decision

  • RehearingRehearing, grantedRehearing, deniedGranted in part

    “STANDARD OF REVIEW The party requesting rehearing has the burden to show that the decision should be modified. Under 37 C.F.R. § 42.71(d), the request for rehearing must identify, specifically, all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” slip op. at 2

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundDecided for patent owner

    “with tolerability, we acknowledge that our Decision regarding the combination of Pinchasi and Flechter does. See Dec. 32–33. Accordingly, we grant Patent Owner’s request for reconsideration as to this portion of our Decision. We, therefore, do not rely on the efficacy data of Flechter in Section II.E.2 of the Final Written Decision as the basis for rejecting Patent Owner’s argument regarding the lack of motivation to combine Pinchasi and Flechter. Nevertheless, we are not persuaded by Patent Owner’s argument that Flechter suggests that less frequent injections were less tolerable than daily injections reported in Meiner.3 In particular, Patent Owner points us to the Patent Owner Response, which compares the alternate-day data in Flechter with the daily administration data of Meiner. Reh’g Req. 7–8 (citing PO Resp. 35–36). Although Flechter itself did not compare the data,” slip op. at 3

  • Expert testimonyPatent owner expert discountedDecided for petitioner
  • Obviousness (§103) › Objective indicia / secondary considerationsNot reached

    “regarding the expected decrease in tolerability in our discussion of secondary considerations. Reh’g Req. 14–15. Patent Owner also states that our “finding that Patent Owner failed to provide any evidence of improved tolerability over the Pinchasi reference (FWD at 26–27) is also incorrect.” Id. at 14. First, we did not state that Patent Owner failed to provide any 8 Khan et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in Relapsing-Remitting Multiple Sclerosis, 14 MULTIPLE SCLEROSIS S296 (2008) (Ex. 1010) (“Khan 2008”). 9 Caon et al., Randomized, Prospective, Rater-Blinded, Four-Year, Pilot Study to Compare the Effect of Daily Versus Every-Other-Day Glatiramer Acetate 20 mg Subcutaneous Injections in RRMS, 72 NEUROLOGY A317 (Mar. 17, 2009) (Ex. 1011) (“Caon 2009”). evidence of improved tolerability—we stated that Patent Owner provided “insufficient evidence of record showing any unexpected results between the claimed requirement of three doses per week compared to dosing every other day.” Dec. 26–27 (emphasis added). As explained above, we did not find Patent Owner’s characterizations of the prior art, including Cohen, persuasive.” slip op. at 8

  § 103 obviousness
  Patents in suitUS 8,399,413

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.