• Luye Pharma Group Ltd. / Luye Pharma(Usa) Ltd. et al. v. Alkermes Pharma Ireland Ltd.No claims unpatentable
  PTAB · Nov 28, 2017 · IPR2016-01096 · APJ Lora M Green · IPR · Final written decision

  Claims 1–13 and 17–23 were not shown unpatentable because Petitioner did not prove the claimed viscosity was necessarily present in either obviousness combination.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “In that regard, we note that Petitioner must “meet a high standard in order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis—the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art.” PAR Pharm., Inc., 773 F.3d at 1195‒ 96.” slip op. at 17

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

    “In the Institution Decision, we determined that none of the terms in the challenged claims require express construction at that time. Dec. Inst. 6 (citing Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (noting that only claim terms which are in controversy need to be construed, and then only to the extent necessary to resolve the controversy)); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017). Petitioner offers explicit constructions of several claim terms (Pet. 19‒22), as did Patent Owner in its Preliminary Response (Prelim. Resp. 9‒12). In its full Response, Patent Owner states that there is no need to expressly construe any of the claim terms. PO Resp. 13‒14. On the present record, we agree with Patent Owner and determine that none of the claim terms require explicit construction for purposes of this Decision.” slip op. at 7

  • Skill levelOther

    “We conclude that, for practical purposes, there is little difference between Petitioner’s and Patent Owner’s definitions of the ordinary artisan. Thus, our analysis would be the same under either Petitioner’s or Patent Owner’s definition. In addition, the level of ordinary skill in the art in this case is reflected by the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8

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

    “Patent Owner argues also that objective indicia of non-obviousness, such as unexpected results and commercial success support the patentability of the challenged claims. PO Resp. 59‒61. As we conclude that the preponderance of evidence of record does not support Petitioner’s obviousness challenge, we need not address Patent Owner’s evidence of secondary indicia.” slip op. at 29

  Patent outcomesUS 6,667,061 not shown unpatentable
  Claim construction§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 6,667,061
• Topgolf International, Inc. v. Amit AgarwalRehearing denied
  PTAB · Sep 5, 2017 · IPR2017-00928 · APJ Lora M Green · IPR · Rehearing

  The Board denied Patent Owner’s rehearing request and left in place institution of inter partes review of claims 1 and 6 based on the reasonable likelihood of obviousness over Bertoncino and Foley.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “decision for an abuse of discretion. See 37 C.F.R. § 42.71(c). An abuse of discretion occurs if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. See Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing that a decision should be modified lies with the party challenging the decision.” Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). In its request for rehearing, the dissatisfied party must, in relevant part, “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); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We address Petitioner’s arguments with these principles in mind.” slip op. at 2

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

    “most end located at the forward portion of the target green ha[s] an elevation that is significantly lower than at its rearmost end.” We note that the term “significantly lower” is a relative term, and Patent Owner does not offer a construction of that term.1 Nor does Patent Owner point us to anything in the prosecution history as providing a construction for that term. In addition, we note further that the Specification of the ’389 patent also does not define the relative term “significantly lower.” The Specification of the ’389 patent, however, teaches that each target green includes a target flag and a receptacle hole that is located near the front section of the green. Ex. 1001, 4:29‒32. According to the Specification of the ’389 patent, the target green is sloped downhill and has the general shape of a concave surface so that the receptacle hole is at the lowest portion of the green. Id. at 4:32‒35. Figure 4C of the ’389 patent is reproduced below: 1 We acknowledge that the ’389 patent expired as of September 2012, and we are, thus, guided by the principle that the words of a claim “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art in question at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc) (internal citation omitted). But, “[i]n determining the meaning of the disputed claim limitation, we look principally to the intrinsic evidence of record, examining the claim language itself, the written description, and the prosecution history, if in evidence.” DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 469 F.3d 1005, 1014 (Fed. Cir. 2006) (citing Phillips, 415 F.3d at 1312–17). Figure 4C shows a cross-sectional view of a target green. Id. at 3:28‒29. As taught by the ’389 patent, “[t]arget green 30 would appear to the golfer at the teeing area to have a sudden drop off near the front portion of the green, and then a gradual slope upwardly toward the back of the green.” Id. at 4:37‒40. Thus, at best, the Specification of the ’389 patent appears to support a construction of the claim limitation of a target green profile whose “forward most end located at the forward portion of the target green ha[s] an elevation that is significantly lower than at its rearmost end” as a green that has a sudden drop off near the front portion of the green and then a gradual slope upward toward the back of the green.” slip op. at 10

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

    “established sufficiently a reasonable likelihood that the challenged claims were rendered obvious by the combination of Bertoncino and Foley. Dec. 22. In particular, as to the limitation that the target green has a profile whose “forward most end located at the forward portion of the target green ha[s] an elevation that is significantly lower than at its rearmost end,” for purposes of institution, we determined: that Petitioner has shown a reasonable likelihood that this claim limitation is rendered obvious by Bertoncino. In particular, Figure 5 of Bertoncino clearly shows that the front ends of the target green on the driving range are substantially lower than the back ends. Ex. 1004, Fig. 5. In addition, we determine that to the extent they are not, Petitioner has reasonably demonstrated that Bertoncino makes such a green obvious by teaching that the ability to see the lie of the ball is dependent on the ability to visually follow the path of the ball (id. at 1:26‒ 29), as well as teaching a “sloped driving range” (id. at 4:12‒ 13; see also id. at 5:37‒39 (“Each target . . . preferably comprises a surface generally sloped towards the tee stands area)). Id. at 19.” slip op. at 3

  • BurdenDecided for petitioner

    “Pet. 49. Figure 5 of Bertoncino, as addressed above, is a schematic perspective of a sloped driving range of Bertoncino. Petitioner also relied on its version of Figure 4 of Bertoncino, which was altered in line with the teaching of that reference that the target green may have only the inner section 22 (Ex. 1004, 6:61–65), and including the slope of the driving range shown in Figure 5 of Bertoncino, reproduced below: Pet. 49 (citing Ex. 1003 ¶ 92). Figure 4 of Bertoncino is a cross-sectional view of the sloped circular target of Figure 3. Ex. 1004, 4:8‒9. That is supported by Petitioner’s expert, Mr. Robbins, who declares that “[a] person of skill in the art would interpret Bertoncino to disclose a range with a plurality of target greens, each of which is composed of a single section with the slope profile of inner section 22” as depicted above. Ex. 1003 ¶ 92. Thus, as we concluded in the Decision on Institution (Dec. 17‒18), Petitioner in its Petition has established reasonably that Bertoncino teaches a target green having a profile wherein the “profile’s forward most end located at the forward portion of the target green having an elevation that is significantly lower than at its rearmost end.” That is, Petitioner has established reasonably for purposes of institution that the target green of Bertoncino meets the “significantly lower” limitation as construed above, as it has as a green that has a sudden drop off near the front portion of the green due to the concave shape of the target green and then a gradual slope upward toward the back of the green. See Ex. 1004, 6:3‒11, 12:6‒12, Figure 4.” slip op. at 12

  Claim constructioncites Phillips
  Patents in suitUS 5,370,389
• Coalition For Affordable Drugs (Adroca) LLC v. Acorda Therapeutics, Inc.No claims unpatentable
  PTAB · Mar 9, 2017 · IPR2015-01853 · APJ Susan L C Mitchell · IPR · Final written decision

  Claims 1–52 of the ’703, claims 1–3, 5–8, and 10–41 of the ’826, claims 1–8 of the ’685, and claims 1–40 of the ’437 were not shown unpatentable under § 103.

  RulingsFinal written decision

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

    “Petitioner asserts constructions for the following claim terms, “less than 15 milligrams,” “release profile,” “matrix,” “improving walking,” and “initiating treatment.” Pet. 18–19. Patent Owner contends that Petitioner has failed to provide an explanation as to why the identified claim terms require construction and why the Board should depart from the plain and ordinary meaning of the terms. Prelim. Resp. 17, n.4. In the Institution Decision, we agreed with Patent Owner and determined that it was unnecessary to construe explicitly the claim terms for purposes of the Institution Decision. See Dec. Instit. 6 (citing Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))). We also determine here that we need not construe expressly any claim term in order to issue a Final Written Decision regarding the patentability of the challenged claims.” slip op. at 7

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “1. Level of Skill Petitioner’s declarants, Drs. Pleasure and Polli, testify that a person of ordinary skill in connection with the ’703 patent would have had an M.D. or Ph.D. in neuroscience or a related field with an understanding of pharmacokinetics and at least some experience in providing drug therapy to MS patients. Ex. 1023 ¶ 16, Ex. 1044 ¶ 13. Additionally, Drs. Pleasure and Polli testify that a person of ordinary skill in the art would have had access to a person having an advanced degree in pharmaceutics or pharmaceutical formulation, specifically oral sustained release formulations, or at least five years of experience in formulating sustained oral release drug products and may work as part of a multi-disciplinary team. Ex. 1023 ¶¶ 16–17; Ex. 1044 ¶¶ 13–14. Patent Owner does not dispute this recitation of the level of ordinary skill in the art. See Ex. 2042 ¶ 68 n.5. We adopt the level of ordinary skill in the art identified by Drs. Pleasure and Polli as it is consistent with the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (stating level of ordinary skill in the art may be reflected by the prior art of record); In re GPAC Inc., 14 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich, 579 F.2d 86, 91 (CCPA 1978).” slip op. at 14

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateEntitled to earlier dateDecided for patent owner

    “In order for claims of the ’703 patent to be entitled to benefit of the filing date of the Provisional, the Provisional must provide written description support for those claims. See 35 U.S.C. § 120. To satisfy the written description requirement of 35 U.S.C. § 112, first paragraph, and provide support for the challenged claims of the ’703 patent under 35 U.S.C. § 120, the Provisional must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See In re Wertheim, 541 F.2d 257, 261, 262 (CCPA 1976); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563– 64 (Fed. Cir. 1991). The primary consideration in determining whether appropriate written description support exists “is factual and depends on the nature of the invention and the amount of knowledge imparted to those skilled in the art by the disclosure.” Union Oil Co. of Cal. v. Atlantic Richfield Co., 208 F.3d 989, 996 (Fed. Cir. 2000).” slip op. at 27

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedDecided for patent owner

    “We are persuaded by Dr. Hayes’ testimony as confirmed by testimony from Drs. Pleasure and Polli, and conclude that the Provisional supports the CavSS ranges in claims 14–15 and 35–36. Dr. Hayes offers credible 34 testimony concerning how one of skill in the art would interpret Table 7 of the Provisional, which depicts essentially the same data as Table 3 of Hayes. See Ex. 2041 ¶ 17. Dr. Hayes interpretation of the data in Table 7 is supported by testimony from Drs. Pleasure and Polli that about two thirds of the measured data fall within one standard deviation and approximately 95 percent of measured values are within two standard deviations from the mean. Id. at 20–22 (citing deposition testimony from Drs. Pleasure and Polli confirming such an understanding). We agree with Dr. Hayes that “[i]n light of the fact that a POSA would immediately recognize that Table 7 of the ’894 Provisional (Ex. 1007-00045) shows possession of measured data beyond even two standard deviations from its reported mean values, a more complete view of the information reported in Table 7 would consider data dispersed beyond two standard deviations from the mean” to encompass a CavSS range from 3.7–37.8 ng/ml. Ex. 2041 ¶ 23. We are not persuaded by Dr. Fairweather’s testimony that Table 7 supports a CavSS of only 15.1 ng/ml to 26.5 ng.ml. See Ex. 1066 ¶ 21. Dr. Fairweather was asked if he could identify where “range” is defined as plus or minus one standard deviation, and he replied that he could not identify where he found such a definition, Ex. 2176, 44:13–22, but Dr. Fairweather confirmed such a definition is not how he would define “range” in his usual practice, Id. at 92:20–93:21. See also id. at 108:5–11 (conceding there may not be any document that defines “range” as one 35 standard deviation from the mean). When asked whether he could justify the range that he provided for CavSS in his declaration, Dr. Fairweather stated that he could not. Id. at 104:25–105:2. He testified that he conceded the smallest range so as to avoid a discussion of what’s the proper definition for range. Id. at 104:16–20. Dr. Fairweather stated twice that he was not a person of skill in the art and would not be able to answer what assumptions such a person would make when reviewing Table 7 of the Provisional. Id. 136:16–23, 138:14–139:7. Finally, Dr. Fairweather also testified that he could not rule out whether the CavSS data for the 10 mg b.i.d. dose described in Table 7 of the Provisional had a range of at least 15 to 35 ng/ml. Id. at 90:9–92:19. In light of these statements, we do not credit Dr. Fairweather’s testimony.” slip op. at 34

  Patent outcomesUS 8,007,826 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · Graham
  Patents in suitUS 8,007,826
• Coalition For Affordable Drugs Viii, LLC v. The Trustees Of The University Of PennsylvaniaNo claims unpatentable
  PTAB · Mar 6, 2017 · IPR2015-01836 · APJ Lora M Green · IPR · Final written decision

  Claims 1–8 were not shown unpatentable under § 103 because the prior art did not establish a reasonable expectation of success using lomitapide in the claimed dosing regimen.

  RulingsFinal written decision

  • BurdenNot shown unpatentable

    “The reasonable expectation of success requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). As to reasonable expectation of success, we agree with Patent Owner that the ordinary artisan would not have had a reasonable expectation of success of combining Pink Sheet with Chang to arrive at the claimed invention. To the extent that Petitioner relies on our Institution Decision, we note that decision was based on the evidence of record at that time. The evidence advanced by Patent Owner during trial, discussed herein, however, tips the scale in favor of a finding different from that set forth in our Institution Decision. slip op. at 36

  • ExcludeMotion to exclude, deniedMixed

    “As to Exhibit 1052, which is the Deposition Transcript of S. David Kimball, and which Patent Owner acknowledges that Petitioner cites in its Reply, Patent Owner argues that it timely objected to the exhibit as an improper duplicate of Exhibit 2304. Mot. Exclude 7. Petitioner responds that Exhibits 2304 and 1052 are the transcripts of Petitioner’s expert. Opp. Mot. Exclude 4. Although acknowledging that the party taking the deposition normally files the transcript, Petitioner asserts that its Reply cites to Ex. 1056, and Patent Owner does not cite to either exhibit. Id. Patent Owner replies that Exhibit 2304 also contains Dr. Kimball’s signed errata sheet and is, thus, the more complete of the two documents. Reply Mot. Exclude. 3. Patent Owner asserts that the citations in Petitioner’s Reply can be updated to reflect the correct exhibit number, if necessary. Id. Given the posture of this proceeding, that is, it is at final written decision, and as Patent Owner notes, the two documents are not exact duplicates, we decline to exclude Ex. 1056, but will allow both Exhibit 1056 and 2034 to remain in the record.” slip op. at 44

  • PTAB / AIA Trials › Motions to amend / substitute claimsNot reached

    “the unrebutted evidence of commercial success further supports the patentability of the challenged claims. Looking at the entire record before us, we conclude that Petitioner has not meet its burden to establish unpatentability of challenged claims 1‒8 by a preponderance of the evidence over the combination of Pink Sheet and Chang. E. Motion to Amend As discussed above, because we conclude that Petitioner has not demonstrated the obviousness of the claims by a preponderance of the evidence, we need not reach the merits of Patent Owner’s contingent Motion to Amend (Paper 24). We, thus, dismiss the motion a moot.” slip op. at 44

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “biotechnology and medical device companies.” Id. The press release does not even mention Dr. Stein. Thus, there is nothing in the press release suggesting that the ordinary artisan in the cardiovascular/cardiac field, or interested in MTP inhibitors, should attend the presentation. We, therefore, decline to credit Dr. Mayersohn’s testimony that “[a]person of ordinary skill in the art interested in the development of MTP inhibitors could apparently have attended the meeting or accessed the presentation itself via webcast or on the PPD website shortly thereafter” (Ex. 1003 ¶ 25 (citing the PPD Press Release)), as there was nothing in the press release discussing MTP inhibitors. That finding informs our analysis of the factors set forth in Klopfenstein. Thus, although the ordinary artisan may have been able to copy the presentation, and although there may have been an expectation that the materials could be copied, Petitioner does not provide any evidence establishing that the target audience would have been an ordinary artisan in the relevant field.” slip op. at 19

  Patent outcomesUS 7,932,268 not shown unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,932,268
• Bioactive Laboratories v. BTG International Inc.Rehearing denied
  PTAB · Aug 2, 2016 · IPR2015-01305 · APJ Toni R Scheiner · IPR · Rehearing

  The Board denied BioActive Laboratories’ rehearing request, leaving institution denied for claims 1–22 because the ’352 patent was not shown to be prior art.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “ANALYSIS When considering a request for rehearing, the Board reviews its decision for an abuse of discretion. 37 C.F.R. § 42.71(c). The party requesting rehearing bears the burden of showing that the decision should be modified, and “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked.” 37 C.F.R. § 42.71(d).” slip op. at 2

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

    “After reviewing the arguments and evidence presented in the Petition, however, we were not persuaded that Petitioner had shown that the ’352 patent fails to provide proper written description support or enablement for the claims of the ’414 patent. Accordingly, we were not persuaded that the ’352 patent is prior art to the claims of the ’414 patent and declined to institute an inter partes review on grounds based on the ’352 patent. Dec. 10–11.” slip op. at 3

  • Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedNot shown unpatentable

    “anticipated by, and claims 8 and 19 are unpatentable over U.S. Patent No. 4,489,352 (Ex. 1004, “the ’352 patent”). Petitioner acknowledged that the ’352 patent “is listed in the priority chain on the face of the ’414 patent” (Pet. 5), and that the specifications of the ’352 patent and the ’414 patent are identical (id. at 29), but argued that: [T]he ’352 patent is in fact prior art because not one application in the ’414 patent’s alleged priority chain complies with the requirements of 35 U.S.C. § 112. In particular, the ’414 patent’s priority applications do not describe or enable the full scope of the claimed invention. Therefore, the ’414 patent’s priority claim fails under 35 U.S.C. § 120 and the ’352 patent qualifies as prior art under 35 U.S.C. § 102(b).” slip op. at 2

  • Disclosure Requirements (§112) › Written description (Ariad)Written description adequateNot shown unpatentable

    “[T]he ’352 patent is in fact prior art because not one application in the ’414 patent’s alleged priority chain complies with the requirements of 35 U.S.C. § 112. In particular, the ’414 patent’s priority applications do not describe or enable the full scope of the claimed invention. Therefore, the ’414 patent’s priority claim fails under 35 U.S.C. § 120 and the ’352 patent qualifies as prior art under 35 U.S.C. § 102(b).” slip op. at 2

  Claim construction§ 102 anticipation§ 112 disclosure
  Patents in suitUS 8,048,414
• LG Display Co, Ltd. v. Innovative Display Technologies LLCNo claims unpatentable
  PTAB · Jul 15, 2016 · IPR2015-01717 · APJ Beverly M Bunting · IPR · Final written decision

  Claims 1, 3, 5, 10, 13, 16, 17, 25–29, and 33–35 were held not unpatentable under § 103 over Oe and Etsuo because the combination lacked an adequately supported reason to combine.

  RulingsFinal written decision

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “taken into account. In making this determination, we were aided by expert testimony. According to Dr. Escuti, “a person of ordinary skill in the art relevant to the ’660 Patent would have at least an undergraduate degree in physics, optics, engineering, or applied mathematics AND 3 years of work experience (or a graduate degree) in a field related to optical technology.” Ex. 1004 ¶ 23. Mr. Werner does not take issue with this testimony, and in fact proposes a similar standard: a person of ordinary skill in the art of the ’660 patent would hold an undergraduate degree in physics, material science, electrical engineering, or mathematics and have one or both of the following: (1) three or more years of work experience in a field related to optical technology; or (2) a graduate degree in a field related to optical technology. Ex. 2021 ¶ 76. We find that Mr. Werner’s definition is too limited in that it does not include a person with an undergraduate degree in optics. We, therefore, do not accept his standard and adopt instead Dr. Escuti’s more complete definition.” slip op. at 12

  • Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed

    “Owner’s expert, Mr. Werner (Ex. 2021). We find that both experts have, at times, taken liberties in proffering conclusory statements without real analysis.4 However, it is within our discretion to assign the appropriate weight to the testimony of both Dr. Escuti, and Mr. Werner. See, e.g., 4 Under our rules, expert testimony that does not have a proper basis is entitled to little or no weight. 37 C.F.R. § 42.65(a). Yorkey v. Diab, 601 F.3d 1279, 1284 (Fed. Cir. 2010) (holding the Board has discretion to give more weight to one item of evidence over another “unless no reasonable trier of fact could have done so”); In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004). We, therefore, are not persuaded by Patent Owner’s contention that Dr. Escuti’s testimony be disregarded in its entirety. Instead, we have accorded the testimony of both Dr. Escuti and Mr. Werner the weight that is appropriate in view of the arguments and evidence of record in this trial. 4. Overview of Oe (Ex. 1024)” slip op. at 13

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner

    “Because the terms “width” and “height” are commonly understood, we also consult a general purpose dictionary. “Width” is defined as “the horizontal measurement taken at right angles to the length.” See Merriam- Webster.com, http://www.merriam-webster.com/dictionary/width, (last viewed July 10, 2015). The dictionary definition of height is “the distance from the bottom to the top of something standing upright.” See Merriam- 3 In a related district court proceeding, the claim term “output distribution defined by a greater width component than height component” was determined to have its plain meaning. Ex. 2008, 47. See TR. 21:24–22:8. Webster.com, http://www.merriam-webster.com/dictionary/height, (last viewed July 10, 2015). Within the context of the claims, we are not persuaded by Patent Owner’s contentions that the term “width” is used other than according to its ordinary and customary meaning with respect to the shape of the input edge of the optical conductor, the output distribution of the light source, and the shape of the LED light source. Along this vein, we are not persuaded by Patent Owner’s contentions that the term “height” is used other than according to its ordinary and customary meaning with respect to the light output distribution. Based on this usage in the claims, no express construction is necessary.” slip op. at 10

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentableNot shown unpatentable

    “persuaded Petitioner has provided sufficient articulated reasoning with rational underpinning explaining why one with ordinary skill in the art would have modified the teachings of the applied references to address the noted differences. See KSR, 550 U.S. at 418 (citing In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”)). We consider Petitioner’s first reason to combine Oe and Etsuo “because they are in the same field of backlighting for liquid crystal display devices.” Pet. 36. The mere fact that both Oe and Etsuo are in the same field of endeavor falls short of an adequate rationale. The same field of endeavor analysis is merely the jumping-off point in reaching the determination of whether a claimed invention is obvious. See K-TEC, Inc. v. Vita-Mix Corp., 696 F.3d 1364, 1375 (Fed. Cir. 2012) (to qualify as prior art in an obviousness analysis, references must be analogous art—either from the same field of endeavor, or reasonably pertinent to the problem with which the inventor is involved). Next, we consider Petitioner’s second reason to combine because “both Oe and Etsuo relate to backlight devices that use light sources located at edges of a light guide.” Pet. 36 (citing Ex. 1004 ¶ 165). Although Petitioner relies on the testimony of Dr. Escuti, he does not proffer any persuasive facts, data, or analysis to support his opinion. See Ex. 1004 ¶ 165 (“Also, both Oe and Etsuo relate to backlight devices that use light sources located at edges of a light guide.”). Merely repeating an argument from the Petition in the declaration of a proposed expert does not give that argument probative value. Dr. Escuti’s opinion lacks sufficient support. For this reason, we do not credit the testimony of Dr. Escuti on this issue. See 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”). Petitioner’s second reason is also unavailing because it does not address the entirety of Petitioner’s proposed modification. As discussed above, Petitioner relies on the disclosure in Etsuo for both the position of the plurality of light sources adjacent a single input edge claim element, as well as the output distribution having a greater width component than height component claim element. Petitioner’s reasoning, directed only to the use of light sources at the edge of the light guide, does not explain sufficiently why one of skill in the art would have replaced a single light source positioned adjacent one input edge of Oe, with the plurality of light sources disclosed by Etsuo that have an output distribution defined by a greater width component than height component. We also consider Petitioner’s argument in the Reply that, in addition to Etsuo, Petitioner also relies on Oe’s explicit disclosure of “a plurality of point-like sources of light.” Reply 16–17. Petitioner directs us to the passage of Oe cited in its claim chart (Pet. 40), describing how the light source could be “a plurality of point-like sources of light arranged along the incident surface” (Ex. 1024, 7:30–31). Id. at 16. But Petitioner’s arguments in this regard do not address specifically its proffered reason to combine Oe and Etsuo. Indeed, Petitioner does not explain the relevance of the point-like sources of light to the claim element in question. See 37 C.F.R. § 42.22(a)(2) (requiring a full statement of the reasons for the relief requested, including a detailed explanation of the significance of the evidence including material facts, and the governing law, rules, and precedent). Patent Owner contends that “Petitioner never argues that ‘point-like sources’ are equivalent to LEDs.” PO Resp. 10. We agree. Petitioner’s argument that “Oe discloses a plurality of light sources 4 adjacent to the input edges” (Pet. 35 (citing Ex. 1024, 6:5–13; Ex. 1004 ¶ 161)) makes no mention of the specific passage in Oe concerning the point-like sources of light. Indeed, the cited passage states that:” slip op. at 20

  Patent outcomesUS 7,404,660 not shown unpatentable
  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 7,404,660
• Fresenius-Kabi USA LLC v. Cubist Pharmaceuticals, Inc.All claims unpatentable
  PTAB · May 12, 2016 · IPR2015-00223 · APJ Christopher G Paulraj · IPR · Final written decision

  Claims 51 and 52 are unpatentable as obvious under §103 over the ’226 patent, Rotschafer, and Woodworth.

  RulingsFinal written decision

  • BurdenUnpatentable

    “unexpected results is not sufficient to overcome the showing of obviousness. III. CONCLUSION We conclude that Petitioner has demonstrated by a preponderance of the evidence that claims 51 and 52 are rendered obvious under 35 U.S.C. § 103 by the combination of Woodworth, the ’226 patent, and Rotschafer. This is a Final Written Decision of the Board under 35 U.S.C. 318(a). Parties to the proceeding seeking judicial review of this Decision must comply with the notice and service requirements of 37 C.F.R. § 90.2. IV. ORDER Accordingly, it is ORDERED that claims 51 and 52 of U.S. Patent 6,852,689 are held to be unpatentable;” slip op. at 22

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

    “interval that minimizes skeletal muscle toxicity,” which is recited in independent claim 47, as not requiring anything beyond administering daptomycin at the express dosage intervals recited in the claim. As we noted, the requirement of “minimiz[ing] skeletal muscle toxicity” would be understood as nothing more than the intended result or consequence of administering daptomycin at the specifically recited dosage interval. Dec. 6. Our interpretation is consistent with the Specification, which repeatedly indicates that lengthening the dosing interval is what minimizes skeletal muscle toxicity. The Specification does not indicate that the minimization of skeletal muscle toxicity is due to any variable other than extending the dosage interval to once every 24 hours or more. See, e.g., Ex. 1001, 5:16–19 (“Without wishing to be being bound by any theory, these results may be explained by the hypothesis that skeletal muscle toxicity is related to time between doses for repair of skeletal muscle damage.”).” slip op. at 7

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

    “2. Remaining Claim Terms We determine that, for purpose of this Final Written Decision, none of the other terms in the challenged claims requires express construction.” slip op. at 8

  • Skill levelOther

  Patent outcomesUS 6,852,689 unpatentable
  Claim construction§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 6,852,689
• Fresenius-Kabi USA LLC v. Cubist Pharmaceuticals, Inc.All claims unpatentable
  PTAB · May 12, 2016 · IPR2015-00227 · APJ Christopher G Paulraj · IPR · Final written decision

  Claims 16, 17, 34, and 35 are unpatentable as obvious over the ’226 patent and Woodworth.

  RulingsFinal written decision

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

    “We find nothing in the prosecution history, however, to suggest clearly that either the examiner or the applicants considered a “dosage interval that minimizes skeletal toxicity” to require anything beyond administering daptomycin at the expressly recited dosage interval required by claim 47 (i.e., once every 48 hours). Indeed, in amending then pending claim 32 in response to the Examiner’s § 112, ¶ 2 rejection on the grounds that the claims do not recite an “essential element of the invention,” the applicants added the entirety of the language “wherein said single dose is formulated for administration to a human patient at a dosage interval of once every 24 hours to once weekly and that does not result in muscle toxicity.” Ex. 2013, 3; Ex. 2014, 3. Thus, Patent Owner plainly equated a dosage interval that does not result in muscle toxicity to once every 24 hours to once weekly. Patent Owner has not pointed to any other intrinsic or extrinsic evidence to indicate what else might be required for a dosage interval that minimizes skeletal muscle toxicity. Accordingly, we maintain our claim construction for purposes of this Final Decision.6” slip op. at 8

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

    “2. Remaining Claim Terms We determine that, for purpose of this Final Written Decision, none of the other terms in the challenged claims requires express construction.” slip op. at 9

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

    “We find that the teachings of the ’226 patent and Woodworth, when considered together and in their entirety, would have guided the skilled artisan to once-daily administration of daptomycin at doses of 4 mg/kg and 6 mg/kg. Contrary to Patent Owner’s arguments, the fact that an infinite number of values can fall within the prior art’s non-integer range does not necessarily render its disclosure boundless or otherwise meaningless. We recognize that the ’226 patent discloses a broader dosing range than what it claimed, calculated as between 1.4 and 14 mg/kg, which is not limited to only integer values falling within that range. Nonetheless, we find that the ’226 patent would sufficiently suggest to the skilled artisan that daptomycin can be administered at dosage amounts falling within the disclosed range as a “single daily dose” (i.e., a dosing interval of once every 24 hours) over extended time periods. Ex. 1008, 10:59–63. Moreover, as noted by the Federal Circuit in the Hospira decision, Woodworth more specifically discloses once-daily administration of daptomycin at doses falling within the narrower range of 4 to 6 mg/kg. Ex. 1031, 20. We reach the same conclusion based on our own review of Woodworth. In particular, the endpoints of the range disclosed in the abstract and conclusion of Woodworth, as well as the specific dosages of 4 mg/kg and 6 mg/kg used in the single-dose studies described therein, would have led a skilled artisan to try the claimed dosage amounts for a daptomycin dosing regimen. See Ex. 1009, Abstract (“doses of 4 to 6 mg/kg/day, possibly in divided doses, are predicted to be effective”), 319 (“volunteers were administered daptomycin in successive single doses of 2, 3, 4, and 6 mg/kg”), 324 (“our data suggest that good antibacterial activity would be produced from single doses of 4 to 6 mg/kg”).” slip op. at 12

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner

    “We are unpersuaded by these arguments, as Woodworth plainly concludes, based on the single dose studies described therein, that daptomycin “doses of 4 to 6 mg/kg/day, possibly in divided doses, are predicted to be effective.” Ex. 1009, Abstract. We agree with the Federal Circuit that, “[w]hile it is true that the Woodworth reference is predictive in nature, it is based on extensive laboratory research, and its predictions of the efficacy of a dosage regimen of 4 mg/kg to 6 mg/kg at daily intervals give rise to a reasonable expectation that dosages in that amount would be effective in patients.” Ex. 1031, 21. We do not consider Woodworth’s description of a simulation that required an “unrealistic dose” of 20 to 25 mg/kg based on certain assumptions to teach away from the claimed doses of 4 mg/kg and 6 mg/kg because it does “not criticize, discredit, or otherwise discourage investigation into the invention claimed.” Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013). Indeed, Patent Owner fails to mention in its briefing that Woodworth also describes “[a]nother simulation [that] used concentrations closer to those anticipated from multiple dosing of 6 mg/kg.” Reply 14; Ex. 1009, 324.” slip op. at 14

  Patent outcomesUS 6,468,967 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 6,468,967
• Par Pharmaceutical, Inc. v. Novartis AGInstitution denied
  PTAB · Apr 28, 2016 · IPR2016-00078 · APJ Christopher L Crumbley · IPR · Institution

  The Board denied institution because Par did not show a reasonable likelihood that claim 7 was obvious over Cottens, Kimball, Kahan, and Morris.

  RulingsInstitution decision

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

    “effective amounts of two compounds. As Novartis points out, the term “coadministration” is explicitly defined in the specification of the ’518 patent, as follows: By “co-administration” is meant administration of the 40-O-(2- hydroxyethyl)-rapamycin and the IL-2 transcription inhibitor, e.g., cyclosporin A, together or at substantially the same time (e.g., within fifteen minutes or less), either in the same vehicle or in separate vehicles, so that upon oral administration, for example, both compounds are present simultaneously in the stomach. Prelim. Resp. 4 (quoting Ex. 1001, 6:29–35) (emphasis omitted). We agree with Novartis that the patentee acted as its own lexicographer, defining “co-administration” with reasonable clarity, deliberateness, and precision as “administration . . . together or at substantially the same time.” The specification also provides two guideposts for determining what is “at substantially the same time”: either within fifteen minutes or less, or so that both compounds are present simultaneously in the stomach. We, therefore, determine that the broadest reasonable interpretation of the claim term co-administering is “administering together or at substantially the same time.”” slip op. at 6

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

    “Upon review of the record, we are persuaded by Novartis’ arguments that the prior art insufficiently discloses co-administering, as explicitly defined in the specification of the ’518 patent. Par’s Petition simply states at various points that the references “disclose co-administering,” without specifically indicating what disclosure in the reference is being relied on, or why a person of ordinary skill in the art would have understood the disclosure to be administration “together or at substantially the same time.” In its element-by-element analysis of the proposed ground of unpatentability, Par identifies where each prior art reference allegedly discloses element [7b], “co-administering synergistically effective amounts of.” Pet. 47–50. We address each in turn. First, Par states that Cottens “directs that the disclosed rapamycin derivatives . . . should be co-administered with cyclosporin A.” Id. at 47 (citing Ex. 1006, 8). This overstates the disclosure of Cottens, especially given the specific definition of co-administering in the ’518 patent. Cottens only states that its derivatives (including everolimus) “may be administered . . . together with other drugs,” and “may be used in combination with” cyclosporin A. Ex. 1006, 8 (emphasis added). Par does not explain why use “in combination with” would be understood by those of skill in the art to mean “administering together or at substantially the same time.” To the contrary, Cottens’ disclosure could reasonably be read as simply referring to administering both drugs “together” as part of a single treatment regimen, but spaced apart in time to avoid possible toxic effects.” slip op. at 11

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

    “As we have found that the combined disclosures of Cottens, Kimball, Kahan, and Morris fail to disclose co-administering either rapamycin or everolimus with cyclosporin A, we are unpersuaded that the record sufficiently establishes that Par would prevail in demonstrating the unpatentability of claim 7 over these references. We, therefore, decline to institute trial on Par’s proposed ground of unpatentability. III. CONCLUSION For the foregoing reasons, we conclude that the information presented in the Petition and Preliminary Response does not establish that there is a reasonable likelihood that Par will prevail in challenging claim 7 of the ’518 patent as unpatentable under § 103(a). IV. ORDER In consideration of the foregoing, it is hereby ordered that the Petition is denied.” slip op. at 13

  Claim construction§ 103 obviousness
  Patents in suitUS 6,455,518
• Organik Kimya As v. Rohm And Haas CompanyNo claims unpatentable
  PTAB · Jun 26, 2015 · IPR2014-00350 · APJ Erica A Franklin · IPR · Final written decision

  Claims 1–7 were not shown unpatentable because the cited combinations did not establish a qualifying swelling agent under the Board’s construction.

  RulingsFinal written decision

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

    “We disagree with Petitioner that the Specification’s use of the term “include,” when describing suitable swelling agents, “mak[es] clear” that bases that are not capable of permeating the shell and swelling the core also fall within the scope of the invention. Id. Rather, the Specification’s use of the word “include,” in this instance, is modified by the phrase immediately following it, i.e., “are those which,” suggesting that suitable swelling agents include only those which exhibit the functional characteristic thereafter described. See Ex. 1001, 8:44. In contrast, the subsequent paragraph of the Specification describes the structural requirement for suitable swelling agents using the word “include,” without modifying it with a restrictive phrase. Instead, when disclosing the volatile, fixed and permanent bases, the word “include” is coupled with the phrases “such as” and “and the like,” signaling open-ended or inclusive categories of these bases. See id. at 8:49– 56. Further, we agree with Patent Owner that the Specification describes a swelling agent not merely as being capable of permeating a shell and swelling the core of a multistage emulsion polymer in the abstract, but specifically under the conditions of the specific process for which the agent is to be used. Indeed, the Specification explains that in its process for preparing emulsion polymers, the core polymer of the multistage emulsion polymer swells when it “is subjected to a basic swelling agent that permeates the shell to at least partially neutralize the hydrophilic-functionality of the core.” Ex. 1001, 9:14–17. Based on the foregoing discussion, in light of the ’004 patent Specification, we construe the claim term “swelling agent” as expressing a structural element, i.e., “an aqueous or gaseous, volatile or fixed base, or combinations thereof,” in functional terms, i.e., “capable of permeating the shell and swelling the core, in the presence of the multistage polymer and monomer, under the conditions of the specific process for which the agent is to be used.” See Greenberg v. Ethicon Endo-Surgery, Inc., 91 F.3d 1580, 1583 (Fed. Cir. 1996) (structural elements, e.g., “filter” and “brake,” may be expressed in functional terms).” slip op. at 8

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

    “After considering the arguments and evidence, we find that Patent Owner has established that a person of ordinary skill in the art would not have been motivated to substitute cresol for toluene in step 2A of Touda’s Example 2. Although cresol and toluene are both solvents, Patent Owner has established with persuasive evidence that cresol’s additional function as a polymerization inhibitor would have defeated the purpose of the solvent in Touda’s step 2A. That step is directed to the production of a filled polymer latex (multi-stage polymer). Ex. 1003, 7:35–56. During step 2A, toluene was added to a monomeric mixture over the course of 6 hours. Id. at 7:49– 50. Then the mixture was maintained at 80 °C for 2 hours to complete the polymerization reaction. Id. at 7:51–52. Dr. Schork attempted to replicate Example 2 with cresol substituting for toluene during step 2A, as proposed by Petitioner. Ex. 2005 ¶¶ 92–95 (citing Declaration Ex. I, “Synthesis Procedure for Touda ’320 Example 2 Modified”). Dr. Schork explained that the result observed from using cresol during step 2A was not surprising: “monomer was only 2.5% converted to polymer after the required eight hours.” Id. ¶ 95. Dr. Schork stated, “[i]n my opinion, these results show that the modified process of Example 2A does not make a core-shell emulsion polymer having a core stage and a shell stage because the cresol inhibits polymerization during the phase intended to make the shell.” Id. Petitioner’s assertion to the contrary—that Dr. Schork’s experiment produced “a meaningful amount of shell stage polymer,”—is merely attorney argument unsupported by any persuasive evidence. Pet. Reply 13. Indeed, Petitioner’s Declarant, Marek W. Urban, Ph.D., did not attempt to replicate Example 2 with the modifications proposed by Petitioner, i.e., substituting cresol for toluene in Step 2A. Accordingly, we conclude that Petitioner has not established that it would have been obvious to modify Touda’s Example 2 to include a polymerization inhibitor.” slip op. at 15

  • Expert testimonyPatent owner expert creditedDecided for patent owner
  • Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Not shown unpatentableNot shown unpatentable

    “Moreover, we agree with Patent Owner that Touda’s Example 2 also does not include a swelling agent, as required by claim 1 of the ’004 patent. PO Resp. 28. In particular, as Patent Owner asserts, Touda does not disclose expressly sodium hydroxide, or any other base, as a “swelling agent,” i.e., being capable of permeating the shell and swelling the core of the emulsion polymer under the conditions of Example 2. Id. Petitioner asserts that even if our construction of “swelling agent” requires a base that permeates the shell and swells the core, Petitioner “has established a prima facie case of inherency under Office practice.” Pet. Reply 10 (citing In re Best, 562 F.2d 1252, 1254 (C.C.P.A. 1977); In re Spada, 911 F.2d 705, 707–08 n.3 (Fed. Cir. 1990); In re Mousa, 479 F. App’x. 348, 353 (Fed. Cir. 2012)), 14. According to Petitioner, sodium hydroxide inherently permeates the shell and swells the core of the polymer particles in Touda because the same polymer particles are described in the ’004 patent as suitable for swelling. Pet. Reply 14. However, Dr. Schork explains that in Touda’s Example 1S, the core is only 5 parts (5%) methacrylic acid and the shell in Example 2A is only 6 parts (6%) acrylic acid, such that the core and the shell are only slightly acidic. Ex. 2005 ¶ 77. Dr. Schork states that a person of skill in the art “would understand that under these conditions, NaOH would at best neutralize the shell, not the core.” Id. According to Dr. Schork, “[g]iven the low levels of acid, the NaOH would be unlikely to permeate and neutralize any part of the particle. Certainly, NaOH would not permeate the shell and swell the core. Instead, to the extent that any swelling occurred, it would take place in the shell.” Id. Again, we are persuaded by Dr. Schork’s testimony and do not find that Petitioner has provided persuasive evidence contradicting Dr. Schork’s opinion. Accordingly, after considering the arguments and evidence, and based upon our construction of the term “swelling agent,” we find that Petitioner has not established that Touda discloses sodium hydroxide as a “swelling agent” in the process of Example 2.” slip op. at 16

  Patent outcomesUS 6,252,004 not shown unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 6,252,004

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.