• Sports Nutrition Research, Ltd. v. Chemi NutraRehearing denied
  PTAB · Apr 3, 2020 · DER2013-00001 · APJ Jameson Lee · DER · Rehearing

  The Board denied rehearing and left in place its denial of institution because Petitioner showed no abuse of discretion in finding insufficient evidence of derivation.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “On request for rehearing, the burden of showing a decision on whether to institute trial should be modified lies with the party challenging the decision. 37 C.F.R. § 42.71(d). When rehearing a decision on petition, a panel will review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). The request for rehearing must 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. 37 C.F.R. § 42.71(d). After considering the Request for Rehearing, we determine that Petitioner has not demonstrated that we abused our discretion in denying institution. For reasons discussed below, we decline to modify the Decision. Accordingly, the Request for Rehearing is denied.” slip op. at 2

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

    “In essence, Petitioner is arguing that a derivation proceeding should always be instituted no matter how deficient is the initial evidence presented by Petitioner in the Petition, because both Petitioner and Respondent can submit evidence after institution of trial. We disagree. In the above-quoted argument, Petitioner is referring to hypothetical evidence “to be” developed during trial. We cannot make a decision on whether to institute trial based on non-existent evidence. We properly reviewed the evidence submitted by Petitioner and determined that that evidence does not meet the substantial evidence standard for instituting a derivation proceeding.” slip op. at 5

  • PTAB / AIA Trials › Constitutional / APA (Arthrex, Oil States, due process)Decided for patent owner

    “The constitutional arguments are without merit. The Federal Circuit has held that there is “no constitutional infirmity in [an] institution decision as the statute clearly bestows such authority on the Director pursuant to 35 U.S.C. § 314.” Arthrex, 941 F.3d at 1340. Arthrex’s reasoning likewise applies to derivation proceedings under the AIA. See 35 U.S.C. § 135(a)(1). The Decision will not be vacated. Nor will a new panel be appointed.” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

    “of the MPEP. Paper 17, 4. These authorities, however, articulate general principles and do not support Petitioner’s assertion that the specific wherein clause at issue here represents merely an intended result and thus should not be accorded weight in determining patentability. Indeed, in Hoffer, the Court upheld the district court’s reading of the “whereby clause” at issue there as an actual limitation and not merely an intended result.3 Hoffer, 405 F.3d at 1330. “[W]hen the ‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. at 1329.” slip op. at 9

  Claim construction
  Patents in suitUS 10,869,843
• Grünenthal GmbH v. Antecip Bioventures II LLCRehearing denied
  PTAB · Mar 26, 2020 · PGR2018-00001 · APJ Grace Karaffa Obermann · PGR · Rehearing

  The Board denied Patent Owner’s rehearing request, leaving claims 3–30 unpatentable for lack of enablement because the specification does not guide an artisan to practice their full scope without undue experimentation.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “Upon request for rehearing, we review our decision for an abuse of discretion. 37 C.F.R. § 42.71(c). “The burden of showing a decision should be modified lies with the party challenging the decision.” 37 C.F.R. § 42.71(d). “The request must 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.” Id. Based on an application of those principles, we deny the Request for Rehearing.” slip op. at 2

  • Expert testimonyOther

    “zolendronic acid dosage forms could achieve bioavailabilities as high as 1.1% to “a belie[f] in ‘fairies.’” Req. Reh’g 2 (quoting Dec. 14; Ex. 2014, 137:21–138:8). That testimony represents a small fraction of the totality of evidence that undergirds our finding that an ordinarily skilled artisan generally would have expected that attaining a human bioavailability for zolendronic acid above 1% required an enhancer. See Dec. 12–21 (citing substantial evidence for that proposition). Even if we set aside the testimony misattributed to Dr. Wargin, substantial evidence supports that finding.” slip op. at 3

  • Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledUnpatentable

    “unenhanced dosage form of zoledronic acid disclosed in Aronhime or Exhibit 2026 would have attained a bioavailability that falls within the scope of the challenged claims. The key is whether an ordinarily skilled artisan, reading the disclosure of the ’268 Patent, would have been equipped to practice the full scope of the claimed invention. We did not overlook or misapprehend Exhibit 2026. We correctly determined that, in this unpredictable field of pharmaceutical formulation, an ordinarily skilled artisan would have required direction (lacking in the Specification or the prior art) explaining how to prepare dosage forms that meet the full range of bioavailabilities embraced by the challenged claims, including the specified high endpoint human bioavailability of about 4%. See, e.g., Dec. 11–12 (citing undisputed evidence of unpredictable nature of the field of invention (Ex. 1005 ¶ 60)).” slip op. at 7

  § 112 disclosure
  Patents in suitUS 9,539,268
• Cook Group Incorporated / Cook Medical LLC v. Boston Scientific Scimed, Inc.Some claims unpatentable
  PTAB · Dec 28, 2018 · IPR2017-00440 · APJ Robert L Kinder · IPR · Final written decision

  Claims 1–4, 6–7, 10–16, 18, and 20 are unpatentable; claims 5 and 8 are not shown unpatentable. Substitute claims 21, 30, and 38 are unpatentable as obvious over Sackier and Kirsch.

  RulingsFinal written decision

  • Expert testimonyOther

    “3. Dr. Nicosia’s Declaration in support of its Opposition to Patent” slip op. at 7

  • Skill levelOther

    “B. Person of Ordinary Skill in the Art Petitioner proposes that a person of ordinary skill in the art as of the” slip op. at 16

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner

    “B. “clip” The Parties now agree that “clip,” as the term is generally understood,” slip op. at 14

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableUnpatentableMixed

    “as recited in the claim, must be found in a single prior art reference. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). We conclude that Petitioner has not met its burden of showing this element to be present in Sackier because Petitioner combines features from distinct embodiments in Sackier without establishing persuasively that those embodiments are so directly related to each other such that one of ordinary skill in the art, looking at the reference as a whole, would recognize a disclosure of the invention as claimed. Accordingly, although a very close call, we conclude that Petitioner has failed to demonstrate anticipation of claims 1, 12, and 20 by Sackier for this reason.” slip op. at 21

  Patent outcomesUS 9,271,731 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,271,731
• Cook Group Incorporated / Cook Medical LLC v. Boston Scientific Scimed, Inc.No claims unpatentable
  PTAB · Dec 28, 2018 · IPR2017-00435 · APJ Robert L Kinder · IPR · Final written decision

  Claims 1–4, 6–18, and 20 were not shown unpatentable over Malecki; the contingent motion to amend was denied as moot.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

    “construction more persuasive because it is grounded in, and most consistent with, the specification of the ’731 patent. Contrastingly, Petitioner does not offer a specific interpretation of “inner walls” and its arguments are generally based on extrinsic evidence, including claim charts from the related district court litigation (Pet. 15), arguments from related proceedings (Pet. Reply 3), and the prior art reference (Malecki) relied on to challenge the claims (id. at 3–4). Petitioner criticizes the Patent Owner’s position but provides no express interpretation of “inner walls of the first and second clip arms;” instead, Petitioner argues why Patent Owner’s proposed construction is wrong. Pet. Reply 4–5. Dr. Nicosia does not expressly define or otherwise persuasively explain the definition of “inner walls” in his declarations either. See generally Exs. 1037, 1095, and 1109.” slip op. at 12

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Person of Ordinary Skill in the Art Petitioner proposes that a person of ordinary skill in the art as of the time of the filing of the application that became the ’731 patent would have possessed the knowledge and skill of an engineer or similar professional 5 The parties have not introduced evidence of secondary considerations in this proceeding. with at least an undergraduate degree in engineering, or a physician having experience with designing medical devices. Pet. 10 (citing Ex. 1037 ¶ 11). Patent Owner does not dispute Petitioner’s proposal, and we adopt it based on the final record before us. It is also consistent with the level of skill evidenced by the references.” slip op. at 15

  • Expert testimonyPatent owner expert creditedPetitioner expert discountedDecided for patent owner

    “Based on the final trial record, including our interpretation of “inner walls of the first and second clip arms” to mean “the exterior surfaces of the first and second clip arms that are inward-facing relative to the longitudinal axis of the clip,” Petitioner has not persuasively established that Malecki Embodiment #1 discloses this limitation. We find persuasive the testimony of Dr. Vaitekunas, that “[t]he jaws of Malecki Embodiment #1 have four walls,” and a person of ordinary skill in the art “would understand Figure 28A to illustrate links 404, 406 connecting to the side walls of jaws 308C, 310C on the side or lateral wall opposite (or underneath) the one shown in Figure 28A.” Ex. 2010 ¶¶ 66, 68. We agree with Dr. Vaitekunas that a person of ordinary skill in the art would not consider side or lateral walls as “inner walls” under the broadest reasonable interpretation of that term. Thus, the portion of the jaw identified by Petitioner as shaded in green (Pet. 26) is a portion of the side/lateral wall, not an inward-facing wall. See Ex. 2010 ¶ 68. Petitioner has also not persuasively established that linkages 404, 406 contact any outside portion of the inner wall. As noted by Patent Owner above, Petitioner’s expert admits that Malecki does not disclose links 404, 406 contacting the radially inward-facing walls. See Ex. 2012 at 274:12–23. We also do not find persuasive Petitioner’s pin engagement theory. First, neither Petitioner nor Dr. Nicosia persuasively establish that a slot and pin channel (Pet. 15) is used in Malecki Embodiment #1. See Ex. 1095 ¶ 27. As pointed out by Dr. Vaitekunas, Petitioner’s theory that an engagement between a pin and a pin hole satisfies the “engaging the inner walls of the first and second clip arms” limitation is based on structure that is simply not disclosed in Malecki. Ex. 2010 ¶ 69. Further, we agree with Dr. Vaitekunas that “[e]ven if contact does occur between a pin and a pinhole, the contact occurs in the pin hole, not the exterior surface of a radially inward-facing wall.” Id.” slip op. at 25

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “Based on the final trial record, including our interpretation of “inner walls of the first and second clip arms” to mean “the exterior surfaces of the first and second clip arms that are inward-facing relative to the longitudinal axis of the clip,” Petitioner has not persuasively established that Malecki Embodiment #1 discloses this limitation. We find persuasive the testimony of Dr. Vaitekunas, that “[t]he jaws of Malecki Embodiment #1 have four walls,” and a person of ordinary skill in the art “would understand Figure 28A to illustrate links 404, 406 connecting to the side walls of jaws 308C, 310C on the side or lateral wall opposite (or underneath) the one shown in Figure 28A.” Ex. 2010 ¶¶ 66, 68. We agree with Dr. Vaitekunas that a person of ordinary skill in the art would not consider side or lateral walls as “inner walls” under the broadest reasonable interpretation of that term. Thus, the portion of the jaw identified by Petitioner as shaded in green (Pet. 26) is a portion of the side/lateral wall, not an inward-facing wall. See Ex. 2010 ¶ 68. Petitioner has also not persuasively established that linkages 404, 406 contact any outside portion of the inner wall. As noted by Patent Owner above, Petitioner’s expert admits that Malecki does not disclose links 404, 406 contacting the radially inward-facing walls. See Ex. 2012 at 274:12–23. We also do not find persuasive Petitioner’s pin engagement theory. First, neither Petitioner nor Dr. Nicosia persuasively establish that a slot and pin channel (Pet. 15) is used in Malecki Embodiment #1. See Ex. 1095 ¶ 27. As pointed out by Dr. Vaitekunas, Petitioner’s theory that an engagement between a pin and a pin hole satisfies the “engaging the inner walls of the first and second clip arms” limitation is based on structure that is simply not disclosed in Malecki. Ex. 2010 ¶ 69. Further, we agree with Dr. Vaitekunas that “[e]ven if contact does occur between a pin and a pinhole, the contact occurs in the pin hole, not the exterior surface of a radially inward-facing wall.” Id. Finally, Petitioner seems to recognize that a modification would be” slip op. at 25

  Patent outcomesUS 9,271,731 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 9,271,731
• Cook Group Incorporated / Cook Medical LLC v. Boston Scientific Scimed, Inc.Some claims unpatentable
  PTAB · Nov 15, 2018 · IPR2017-00135 · APJ Robert L Kinder · IPR · Final written decision

  Claims 1, 3–5, and 10 are unpatentable as obvious over Kimura (claims 1, 3–5) and Kimura with Sackier (claim 10); claims 7, 11–15, and 17 were not shown unpatentable.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “B. Person of Ordinary Skill in the Art Petitioner proposes that a person of ordinary skill in the art as of the time of the filing of the application that became the ’371 patent would have possessed the knowledge and skill of an engineer or similar professional with at least an undergraduate degree in engineering, or a physician having experience with designing medical devices. Pet. 8 (citing Ex. 1029 ¶ 11). Patent Owner does not dispute Petitioner’s proposal, and we adopt it for purposes of this Decision.” slip op. at 15

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “The issue we have with Patent Owner’s contentions, as pointed out by Petitioner, is that Patent Owner does not establish persuasively how its claims require the “reversible open/close” feature and the “tactile feel features.” See Pet. Reply 27–29. Even presuming that these features did indeed drive tremendous commercial success and industry praise for the commercial products, Patent Owner does not adequately explain in its analysis how the claims of the challenged patent require these particular features that drive commercial success. Patent Owner seems to suggest that a break section in the control wire will fracture and that this feature in the commercial product relates to the tactile feel. PO Resp. 57 (citing Ex. 2029 ¶¶ 91–93) (“After the yoke has disengaged, if the handle spool is moved further proximally, a break section in the control wire will fracture, leaving the ball within the yoke and uncoupling the control wire from the distal components of the device.”). This “break section in the control wire” is not, however, claimed or covered in claim 1, the claim that purportedly embodies the commercial product. The claims alleged to cover the product do not specifically require any “tactile feel feature.”3 Likewise, while the claims may allow for an opening and closing of the clip assembly, there is no requirement in these claims that the clip assembly, as “demanded” by physicians, repeatedly open and close. Thus, both of the drivers of commercial success and industry praise are not commensurate in scope with the claims of the patented invention. See Ex. 1046 ¶¶ 23–29 (explaining how features are not claimed).” slip op. at 16

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for patent owner

    “district court proceeding, Petitioner contends that “coupled to the sheath” means “slideable inside the sheath” and “the sheath confines the bushing.” Pet. 9. Petitioner provides no additional support. The district court tentatively rejected this broad interpretation. See Ex. 2003, 27–28 (“[T]he Court recommends that ‘coupled to the sheath’ be construed as ‘linked together, connected, or joined, but not slidable inside the sheath.’”). Patent Owner contends that Petitioner’s proposed construction of “coupled to the sheath” is “unreasonably broad,” but provides little citation to the intrinsic record before us. Prelim. Resp. 13–14. Instead, Patent Owner notes that the plain and ordinary meaning of coupled is “linked together, connected, or joined,” citing to an unrelated Federal Circuit decision as well as the related district court determination. Id. at 14; Ex. 2003, 28. In our proceeding, Petitioner has not provided persuasive evidence or argument to support its claim interpretation by merely pointing to what Patent Owner purportedly argued in district court. Based on the final record before us, “coupled to the sheath” means “linked together, connected, or joined” to the sheath. Our construction is consistent with the district court’s analysis and reflects the common understanding of the term “coupled” in the mechanical arts to require more than simply abutting or contacting. See generally Ex Parte Paul Robert Homrich, Appeal 2014-005786, 2016 WL 3541285, at *3 (PTAB, June 27, 2016) (“When used in mechanical systems, the plain and ordinary meaning of ‘coupled’ means to link together or connect,” and coupled requires more than contact or abut.).” slip op. at 10

  • Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable

    “We are not persuaded that Petitioner has demonstrated sufficiently that Adams discloses “a bushing extending between a proximal end coupled to the sheath,” (Ex. 1027, 17:4–5) as required by claim 1 of the ’371 patent. Based on the final record, Petitioner’s contention that retainer 110 [bushing] is slidable inside the sheath, or confined by the sheath, does not establish persuasively that the proximal end of the bushing is coupled to the sheath as required by claim 1. The claimed coupling must be “proximal coupling” and Petitioner can only point to distal coupling via distal tabs 118, 119 (Pet. Supp. Reply 6) – this is not “proximal” coupling. Further, for the bushing and the sheath to be coupled requires them to be “linked together, connected, or joined” in some manner and Petitioner has not established any such connection for proximal coupling. Petitioner also has failed to establish a persuasive reason for linking or connecting retainer 110 and sheath 112 – indeed, doing so would negatively impact the ability of retainer 110 to freely slide out of sheath 112. See Prelim. Resp. 27. Adams suggest that when control wire 108 is actuated and the clip is locked into the lock sleeve, retainer release 109 pulls retainer 110 back, disengaging retainer tabs 118, 119 from the two retainer holes as depicted in Figure 4.” Ex. 1023, 7:26–44 Finally, we note that our decision would not change if we adopted the district court’s claim interpretation. The district court adopted a claim construction of “a bushing extending between a proximal end coupled to the sheath” as “linked together, connected, or joined, but not slidable inside the sheath.” Ex. 2003, 28 (emphasis added). Should the district court’s interpretation be the correct one, Patent Owner’s position is much stronger whereas Petitioner’s theory is based on slidable movement. See Pet. 9 (arguing for “slideable inside the sheath” and “the sheath confines the bushing”); Pet. Supp. Reply 6. Having now considered the evidence in the complete record established during trial, we are not persuaded that Petitioner has demonstrated by a preponderance of the evidence that claim 1 would have been anticipated by Adams. Petitioner has not established persuasively that Adams discloses “a bushing extending between a proximal end coupled to the sheath.” For this reason, Petitioner has failed to prove by a preponderance of the evidence that Adams anticipates claim 1.” slip op. at 22

  Patent outcomesUS 8,974,371 mixed
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,974,371
• L’Oréal USA, Inc. v. Liqwd, Inc.Rehearing denied
  PTAB · Oct 18, 2018 · PGR2018-00024 · APJ Christopher M Kaiser · PGR · Rehearing

  The Board denied rehearing, leaving in place its denial of institution because Petitioner did not show an abuse of discretion in construing “bleach powder” or assessing written-description support.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “The burden of showing a decision should be modified lies with the party challenging the decision.” 37 C.F.R. § 42.71(d). We “review [our] decision for an abuse of discretion.” Id. § 42.71(c). In addition, we may not consider an argument made in a request for rehearing unless the request “specifically identif[ies] . . . the place where [that argument] was previously addressed in a motion, an opposition, or a reply.” Id. § 42.71(d). After considering the Request for Rehearing, we determine that Petitioner has not demonstrated that we abused our discretion in denying institution. Accordingly, we deny the Request for Rehearing. slip op. at 2

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

    “reconsider the issue of our construction of “bleach powder.” The parties agree that the specification of the ’954 patent does not contain an express definition of “bleach powder,” so we are required to give the term its “ordinary and customary meaning, as would be understood by one of ordinary skill in the art in the context of the entire disclosure.” Translogic, 504 F.3d at 1257; see Pet. 27–28 (arguing that, “[a]bsent any . . . clear intent, the BRI must be consistent with the interpretation that those skilled in the art would reach,” then offering no particular construction of “bleach powder”); Prelim. Resp. 29–30 (“A person of ordinary skill in the art would have understood that bleach powder combines persulfates with alkalinizing compounds . . . in a fine dry particulate form.” (citing only sources outside the ’954 patent)). In arguments that we may consider, the parties draw our attention to six sources of evidence about the ordinary understanding in the art of “bleach powder.” Req. 2–5 (citing Ex. 1039, 48:9–49:9); Prelim. Resp. 29– 30 (citing Ex. 1002, 15:45–65; Ex. 1011, 17; Ex. 2005, 6; Ex. 2007, 3; Ex. 2012 ¶¶ 34–36). There is evidence that supports Patent Owner’s view that the ordinary meaning of “bleach powder” is a powder that contains an alkalizing agent in addition to persulfates, as opposed to merely a persulfate powder. A textbook called “Hair Preparations” by Thomas Clausen and others states that, at least in paste bleaches, “a bleach powder” is used that “consists of a peroxodisulfate, an alkalinizing agent,” and other ingredients. Ex. 1011, 17. In the context of cream and gel bleaches, this reference teaches that “[p]eroxosulfate . . . can be added as a bleaching powder” but is silent about whether the “bleaching powder” contains any additional ingredients. Id. In a book chapter on “Hair Coloring” by Keith C. Brown, a “bleach booster” powder is discussed that “is usually a mixture of ammonium and potassium persulfates” and that has “metasilicates mixed in with the persulfates” to provide “[a]lkaline pH.” Ex. 2005, 6. Against this evidence is the testimony of Dr. Borish that “powder lighteners” or “bleach powders” include “persulfate salts.” Ex. 1039, 48:9–49:9. But Dr. Borish does not state affirmatively that the persulfate salt is all that is required for a powder to be a bleach powder, only that a persulfate salt is a necessary component of a bleach powder. Id. Accordingly, his testimony does not outweigh the evidence that, to a person of ordinary skill in the art, a bleach powder contains both a persulfate salt and an alkalizing agent. We are not persuaded, therefore, that we abused our discretion by construing “bleach powder” to require both of those components.” slip op. at 6

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

    “After considering the Request for Rehearing, we determine that Petitioner has not demonstrated that we abused our discretion in denying institution. Accordingly, we deny the Request for Rehearing.” slip op. at 2

  Claim construction
  Patents in suitUS 9,668,954
• Apotex Inc. / Apotex Corp. v. Celgene CorporationInstitution denied
  PTAB · Sep 27, 2018 · IPR2018-00685 · APJ Toni R Scheiner · IPR · Institution

  The Board denied institution: the obviousness grounds repeated substantially the same art and arguments considered in prosecution, and the press release was not shown to be a printed publication.

  RulingsInstitution decision

  • PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied

    “As discussed above in Section D2, the Examiner was ultimately persuaded that Applicant’s evidence of unexpected results—i.e., the overall response rate elicited by lenalidomide in pretreated mantle cell lymphoma patients—outweighed the evidence supporting his initial determination that it would have been prima facie obvious for one of ordinary skill in the art to use lenalidomide to treat mantle cell lymphoma given the combined teachings of Zeldis, Damaj, Wilson, and Kaufmann. Ex. 2007, 81–82.” slip op. at 24

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

    “As we have determined that Petitioner has not established that Celgene Press Release is available as a prior art printed publication, Petitioner has not shown a reasonable likelihood of prevailing in its assertion that the subject matter of claims 1–4, 8, 9, 15, and 20 of the ’929 patent is anticipated by the Celgene Press Release. Accordingly, we do not institute an inter partes review of claims 1–4, 8, 9, 15, and 20 of the ’929 patent on the ground of anticipation by the Celgene Press Release.” slip op. at 31

  • Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable

    “A reference will be considered publicly accessible if it was ‘disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.’” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (quoting Kyocera, 545 F.3d at 1350). A party seeking to introduce a reference “should produce sufficient proof of its dissemination or that it has otherwise been available and accessible to persons concerned with the art to which the document relates and thus most likely to avail themselves of its contents.” In re Wyer, 655 F.2d 221, 227 (CCPA 1981) (quoting Philips Elec. & Pharm. Indus. Corp. v. Thermal & Elecs. Indus., Inc., 450 F.2d 1164, 1171 (3d Cir. 1971)). As explained by the Federal Circuit, a “determination of whether a reference is a ‘printed publication’ under 35 U.S.C. § 102(b) involves a case-by-case 28 inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.” In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). slip op. at 28

  • Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsNot reached

    “support patentability.” Id. Paragraph 109 of Dr. Thirman’s Declaration is nearly identical to the above passage from the Petition. Following the summary of those prior art teachings, Dr. Thirman asserts “[t]hus, the alleged unexpected properties would have been expected” (Ex. 1002 ¶ 110), but provides no further evidentiary support for the proposition that the results obtained by treating relapsed and/or refractory MCL with lenalidomide would have been expected. Again, during prosecution, the Examiner maintained that the combined prior art (Zeldis, Damaj, Wilson, and Kaufmann) would have given one of ordinary skill in the art a reason to use lenalidomide to treat patients with relapsed and/or refractory mantle cell lymphoma, but concluded that the evidence of obviousness was outweighed by Applicant’s evidence of unexpected results—namely, a 28% overall response rate in patients with relapsed and/or refractory mantle cell lymphoma. Although Drach—given its particular focus on treating mantle cell lymphoma—is stronger evidence than Damaj, Wilson, and Kaufmann that one of ordinary skill in the art would have had a reason to treat MCL patients with lenalidomide, Drach is no more informative as to expected results than the references the Examiner relied on in making out a prima facie case of obviousness, i.e., Damaj, Wilson, and Kaufmann. Essentially, Petitioner and Dr. Thirman disagree with the Examiner’s conclusion that, on balance, the subject matter of the challenged claims would not have been obvious, in light of the level of response in patients 25 with relapsed and/or refractory MCL (as described in Dr. Zhang’s Declaration and the underlying Goy reference), despite one of ordinary skill in the art having had a reason to administer lenalidomide to treat MCL.” slip op. at 25

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denial
  Patents in suitUS 8,741,929
• K/S Himpp v. III Holdings 4, LLCOther
  PTAB · Jun 28, 2018 · IPR2017-00414 · APJ James T Moore · IPR · Final written decision

  Claims 1–7 were not shown unpatentable under § 103 over either Cohen and Martin or Holmes and Martin because the combinations did not establish the claimed separate shaping before mixing.

  RulingsFinal written decision

  • Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner

    “As used herein, the term “hearing aid profile” refers to a collection of acoustic configuration settings for hearing aid 102, which are used by a processor 110 to shape electrical signals related to sounds to compensate for the user's hearing loss. Ex. 1001, 3:11–15. Petitioner states that Patent Owner defined this term in the ’538 patent as “a collection of acoustic configuration settings for hearing aid 102, which are used by processor 110 to shape electrical signals related to sounds to compensate for the user’s hearing loss.” Pet. 15. According to Petitioner, this construction is consistent with the plain and ordinary meaning of the term, relying upon the testimony of its witness Dr. Les Atlas. Pet. 15 (citing Ex. 1003 ¶ 38).10 Patent Owner does not dispute Petitioner’s proposed construction. Resp. 10–11. 10 Dr. Les Atlas is the Petitioner’s witness in this matter. We find him qualified to testify as to the subject matter of this proceeding, by virtue of his education and experience. See Ex. 1003 ¶ 4, and Appendix A thereto. We are cognizant of Patent Owner’s suggestion that we give his testimony “little, if any, weight” because of the similarity of the testimony with Petitioner’s arguments and discrepancies between it and his deposition testimony. Resp. 31–34. We give Dr. Atlas’ testimony appropriate contextual weight herein based upon the content of the testimony itself, and any contrary testimony in Exhibit 2005. We decline to assign generally no weight to his testimony, however. supports, and is consistent with, Petitioner’s proposal. Ex. 1001, 3:12–16. Accordingly, we determine that the broadest reasonable construction, in light of the specification of the ’538 patent, of the term “hearing aid profile” is a “collection of acoustic configuration settings for hearing aid, which are used by a processor to shape electrical signals related to sounds to compensate for a user’s hearing loss.”” slip op. at 8

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

    “For the purposes of our decision, we determine that no other claim terms need explicit construction. See, e.g., Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (citation omitted).” slip op. at 9

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “11 Petitioner defines the level of ordinary skill in the art as someone with a Bachelor’s degree in electrical engineering and at least two years of experience in the field of audio engineering. Pet. 14 (citing Ex. 1003 ¶ 25). Patent Owner does not challenge Petitioner’s definition. Resp. passim. The references in the record support a finding that this is the appropriate level. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of skill in the art). 12 The record contains no allegations or evidence of secondary considerations.” slip op. at 10

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “We find the testimony of Dr. Atlas on the key point of obviousness of pre-mixing processing to be less persuasive than that of Mr. Brown. We also find Dr. Atlas’ testimony falls short of adequately explaining how the combination of Cohen and Martin teaches a nexus (i.e., the “based on both the first [shaped] output signal and the second [shaped] output signal” (emphasis added) (hereinafter, “based on both limitation”) limitation recited in claim 1) between the claim 1 requirements of: (1) a condition precedent of shaping both a first output signal and a second output signal; and (2) a subsequent result of using both the first shaped output signal and the second shaped output signal if the hearing aid is in a third mode. Dr. Atlas assumes that one of ordinary skill in the art would process separately each signal and then mix them. Ex. 1003 ¶ 66. We find Dr. Atlas’ assumption is flawed. Specifically, in making this assumption, Dr. Atlas does not address adequately how the combination of Cohen and Martin opines “it would have been obvious to a person of ordinary skill in the art” (emphasis added), his later sentences appears to base his opinion principally on the reason one of ordinary skill in the art could do it. Id. In particular, he testifies: Because Cohen’s hearing aid applies different hearing aid profiles to different input sources, it would have been obvious to a person of ordinary skill in the relevant art to add the functionality of the combination mode as taught by Martin to Cohen’s hearing aid such that the speaker would produce an audible sound based on the output signals of the processor. Combining two signals such that both signals are sent to a speaker to an audible combination of sounds, that is where each signal is sufficiently perceived, was well within the technical ability of a person of ordinary skill in the art. To accomplish this would require that each one of the two signals is passed through an appropriate hearing aid profile. For example, it would have been obvious to a person of ordinary skill in the art that a different hearing aid profiles could be used for an audio coil inputs and that of a neighboring conversation and environmental sounds through a microphone. Namely, it is commonly known that the different frequency sensitivity of an audio telecoil versus a microphone can be beneficially compensated for. (Rodriquez, Ex. 1011, Abstract)” slip op. at 24

  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 8,649,538
• Grünenthal GmbH v. Antecip Bioventures II LLCAll claims unpatentable
  PTAB · Jun 22, 2018 · PGR2017-00008 · APJ Sheridan K Snedden · PGR · Final written decision

  Claims 1–17 are unpatentable under § 112(a) for lack of written description because the claimed dosing regimen is not supported by the specification.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “with regard to claim 17. Nonetheless, we are not persuaded by Petitioner’s contentions. Rather, we find that the ’239 patent contains a sufficient written description of an oral dosage form containing “at least 10% zoledronic acid.” The specification describes a full panoply of zoledronic acid concentrations. Liquid compositions may contain “about 10% (w/v) to about 15% (w/v), about 15% (w/v) to about 20% (w/v), about 20% (w/v) to about 30% (w/v), about 30% (w/v) to about 40% (w/v), or about 40% (w/v) to about 50% (w/v) of zoledronic acid.” Ex. 1003, 10:25–28. Solid dosage forms may contain “at least about 10% (w/w), at least about 20% (w/w) . . .” up to “at least about 80% [w/w]” zoledronic acid. Id. at 10:30–32. Solid dosage forms also are described as containing zoledronic acid in ranges beginning from “about 10% (w/w) to about 30% (w/w), about 10% (w/w) to about 20% (w/w) . . .” all the way up to a range of “about 80% (w/w) to about 90% (w/w).” Id. at 10:32–39. The breadth of zoledronic acid concentration ranges disclosed is more comprehensive than, and therefore distinguishable from, the more limited concentration ranges disclosed in Wertheim (claimed range of “at least 35%” not supported by disclosure of 25% to 60% range disclosed in priority application). In short, we determine that a person of ordinary skill in the art – a medical doctor with experience treating CRPS – would have recognized that the “inventor invented what is claimed” and did not overreach in claiming “at least 10% zoledronic acid” in an orally administered dosage form for treating CRPS. See University of Rochester, 358 F.3d at 928 (Fed. Cir. 2004).” slip op. at 21

  • Expert testimonyOther

    “Unocal or Wertheim where the specification clearly allowed persons of ordinary skill in the art to recognize the claimed invention despite the absence of literal support. In Unocal, the original disclosure explicitly described the effects of altering the variables, explicitly described the claimed endpoints as preferred, or explicitly recited them in an original claim. Moreover, persuasive expert testimony was offered to support the finding that the specification reasonably conveyed to one skilled in the relevant art that the inventor possessed the later claimed invention. Unocal, 208 F.3d at 993, 998–99. In Wertheim, the CCPA held that the specification supported the claimed range of 35–60% where the specification described the range of 25–60% along with specific embodiments of 36% and 50%. 541 F.2d at 264–65. In this case, the ’239 patent specification does not clearly allow persons of ordinary skill in the art to recognize the “about 80 mg” endpoint as part of invention described in the ’239 patent. There is no disclosure of “about 80 mg” as a preferred endpoint, no disclosure of a specific embodiment including a dose of 80 mg, nor any other description suggesting the importance or criticality of the “about 80 mg” endpoint.” slip op. at 16

  • Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateWritten description adequateMixed

    “In this case, the ’239 patent specification does not clearly allow persons of ordinary skill in the art to recognize the “about 80 mg” endpoint as part of invention described in the ’239 patent. There is no disclosure of “about 80 mg” as a preferred endpoint, no disclosure of a specific embodiment including a dose of 80 mg, nor any other description suggesting the importance or criticality of the “about 80 mg” endpoint.” slip op. at 16

  Patent outcomesUS 9,283,239 unpatentable
  § 112 disclosure
  Patents in suitUS 9,283,239
• Hyperbranch Medical Technology, Inc. v. Incept LLCAll claims unpatentable
  PTAB · Apr 9, 2018 · IPR2016-01836 · APJ Kristi L R Sawert · IPR · Final written decision

  Claims 1–6 and 8–12 are unpatentable as obvious under § 103 over Rhee ’500 or Rhee ’587, each combined with Bass or Tse.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “Upon review of the parties’ respective definitions of a person of ordinary skill in the art, we adopt Petitioner’s definition as a person with either: (1) a Ph.D. in the field of chemistry, polymer chemistry, chemical engineering, materials science and/or a related field and having at least one year of educational or work experience in the synthesis and development of biocompatible polymer materials; (2) a bachelor’s degree in in [sic] the field of chemistry, polymer chemistry, chemical engineering, materials science and/or a related field and at least two years of work experience in the synthesis and development of biocompatible polymer materials; or (3) any education and experience equivalent to (1) or (2). Pet. 22 (citing Ex. 1003 ¶ 49). We find that Patent Owner’s definition of the ordinarily skilled artisan, i.e., a person having “a Ph.D. degree, or equivalent education, in polymer chemistry, or a bachelor of science degree in chemistry or a closely related field and several years of experience in the development and manufacture of polymer materials for use as tissue sealants,” PO Resp. 15–16 (citing Ex. 2006 ¶ 27), does not differ materially from Petitioner’s definition. Furthermore, our analysis would be the same under either parties’ definition.” slip op. at 9

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther

    “1. “visualization agent” In its Petition, Petitioner proposed interpretations of certain claim terms. Pet. 18–22. The Board determined in its Institution Decision, however, that only the term “visualization agent” required express interpretation. Inst. Dec. 8 (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.”)). The Board set forth the broadest reasonable interpretation of “visualization agent” as “an agent that reflects or emits light at a wavelength detectable to a human eye so that a human eye may visualize the hydrogel coating.” Id. at 9. Neither party challenges that interpretation. See, e.g., Third Tr. 6:15–17. We have reassessed that determination in light of the arguments and evidence adduced at trial, and maintain that determination based on the full record.” slip op. at 11

  • Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner

    “In general, a preamble limits the invention if it recites essential structure or steps, or if it is necessary to give life, meaning, and vitality to the claim.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002) (quotation omitted). “Conversely, a preamble is not limiting where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention.” Id. Here, we determine that the preamble phrase “suitable to coat a tissue of a patient” is not merely a statement of purpose, but instead represents the “essence or a fundamental characteristic of the claimed invention.” Vizio, Inc. v. Int’l Trade Com’n, 605 F.3d 1330, 1340 (Fed. Cir. 2010). In Vizio, the Federal Circuit held that a preamble reciting “for decoding” certain data “is properly construed as a claim limitation” because the apparatus and method claims reciting that preamble “would have little meaning without the intended objective of decoding.” Id. at 1341. Similarly here, we determine that the method step of claim 1—namely, mixing reactive nucleophilic precursor species, electrophilic precursor species, and a visualization agent—would have little meaning without the intended objective of forming a hydrogel coating on the tissue of a patient. Put differently, there would be no reason to perform the method step of claim 1 but for forming a hydrogel coating on the patient’s tissue. See Ex. 1001, 39:56–40:2 (claim 1) (providing that the reactive precursors crosslink after contact with the tissue to form a hydrogel in the form of a coating). Thus, we determine that “suitable to coat a tissue of a patient” is limiting in this case because it gives “life and meaning” to method claim 1. We further find that the arguments and evidence in this case show that skilled artisans would reasonably interpret “suitable to coat a tissue of a patient” as encompassing a biocompatibility requirement. Although Petitioner correctly notes that “[n]one of challenged claims recite the term ‘biocompatible,” Petitioner acknowledges that skilled artisans understand “that hydrogels are, by their nature as water-swelled materials, known to be biocompatible.” Pet. Suppl. Br. 4–5. Petitioner’s expert, Dr. Lowman, declared that “biocompatibility is presumed as a fundamental aspect of the claimed and disclosed inventions.” Ex. 2018 ¶ 40. And in his deposition, Dr. Lowman testified that skilled artisans would understand “biocompatible” to mean that the hydrogel composition is “suitable for use and tolerated by a patient.” Ex. 2019, 13:2–11 (emphasis added). Thus, we agree with Patent Owner that “suitable to coat a tissue of a patient” reasonably encompasses a biocompatibility requirement for the hydrogel composition. slip op. at 12

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

    “3. Motivation to combine the prior art references and reasonable expectation of success Even “[i]f all elements of the claims are found in a combination of prior art references,” “the factfinder should further consider whether a person of ordinary skill in the art would [have been] motivated to combine those references, and whether in making that combination, a person of ordinary skill would have [had] a reasonable expectation of success.” Merck & Cie v. Gnosis S.P.A., 808 F.3d 829, 833 (Fed. Cir. 2015). The “motivation to combine” and “reasonable expectation of success” factors are subsidiary requirements for obviousness subsumed within the Graham factors. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007).” slip op. at 28

  Patent outcomesUS 7,009,034 unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 7,009,034

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.