• Innopharma Licensing, LLC v. Astrazeneca ABInstitution denied
  PTAB · Aug 30, 2017 · IPR2017-00905 · APJ Zhenyu Yang · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1, 3, 10, 11, 13, and 20 were obvious over the asserted prior-art combinations.

  RulingsInstitution decision

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

    “Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314; see 37 C.F.R. §§ 42.4, 42.108. Upon considering the Petition and the Preliminary Response, we determine that Petitioner has not shown a reasonable likelihood that it would prevail in showing the unpatentability of at least one challenged claim. Accordingly, we decline to institute an inter partes review of the ’139 Patent.” slip op. at 2

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

    “As we observed in the Mylan IPR, however, “[i]t is not enough for Petitioner to establish that castor-oil based intramuscular injections of fulvestrant were known; the evidence must provide a reason for one of skill in the art to administer [the claimed] fulvestrant formulation”—which includes specific concentrations of three required excipients in castor oil— “‘intramuscularly’ to” achieve a therapeutically significant blood plasma concentration or dosage “for ‘treating a hormonal dependent benign or malignant disease of the breast or reproductive tract,’ as recited in the challenged claims.” Id. at 29.” slip op. at 24

  • Expert testimonyPetitioner expert discountedDecided for patent owner

    “As Patent Owner points out, however, Dr. El-Ashry relies on one experiment in McLeskey that involved powdered—not oil-based— fulvestrant. Prelim. Resp. 48 (citing Pet. 24; Ex. 1014 ¶¶ 45, 52; Ex. 1008, 707, Fig. 8; Ex. 2002 ¶¶ 92, 160–61). Accordingly, we agree with Patent Owner that this new testimony does not address the question of in vivo bioavailability, which requires an oil-based fulvestrant formulation. Id. (citing Ex. 1011, 28; Ex. 2162, 28; Ex. 2001 ¶¶ 176, 185, 234–43); see also Ex. 1046, 729 (Examiner finding that “the unexpected solubility and the bioavailability of using the specific solvent mixture as recited have been demonstrated”). Patent Owner asserts that Petitioner attempts to rewrite the plain disclosure of McLeskey, by raising opinion testimony directed to what the McLeskey authors may have “hoped” to achieve. Prelim. Resp. 17 (citing Pet. 54). We agree. As Patent Owner argues, the testimony of Dr. El-Ashry “reverses McLeskey’s conclusion of ‘treatment failure’ . . . and instead claims it was a ‘successful treatment.’” Id. at 3. We accord little weight to the testimony of Dr. El-Ashry, which was executed nearly two decades after McLeskey was published, because it runs counter to the statement of McLeskey within its four corners—“treatment failure,” which was reported at or near the time of the experiments.” slip op. at 28

  § 103 obviousnesscites KSR
  Patents in suitUS 8,466,139
• Innopharma Licensing, LLC v. Astrazeneca ABInstitution denied
  PTAB · Aug 30, 2017 · IPR2017-00900 · APJ Robert A Pollock · IPR · Institution

  The Board denied institution because the petition did not show a reasonable likelihood that claims 1–3 and 6 would have been obvious over the asserted combinations.

  RulingsInstitution decision

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

    “Principles of Law A claim is unpatentable under 35 U.S.C. § 103(a) if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which that subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 416. “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. We are, nevertheless, cautioned not to “rel[y] on hindsight reasoning to piece together elements to arrive at the claimed invention.” In re NTP, Inc. 654 F.3d 1279, 1299 (Fed. Cir. 2011) (“Care must be taken to avoid hindsight reconstruction by using the patent in suit as a guide through the maze of prior art references, combining the right references in the right way so as to achieve the result of the claims in suit.” (internal quotations and citations omitted)). Thus, a finding of obviousness “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.” KSR, 550 U.S. at 418 (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)). Accordingly, a party petitioning the Board for a determination of obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009) (quoting Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007)). D.” slip op. at 21

  • PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Denied

    “Patent Owner requests that we exercise our discretion to deny the Petition on the basis that it uses a previous Board decision “as a ‘roadmap’ to address challenges that were advanced, unsuccessfully,” in the Mylan IPR. Prelim. Resp. 5 (quotation omitted). The Mylan IPR, however, involved a different petitioner (Mylan) and, to some extent, a different record. Based on the particular facts of this case, we decline to issue a discretionary denial and, instead, consider the Petition on its merits. Nevertheless, we approach this case cognizant that, in the Mylan IPR, we denied institution of inter partes review of all of the claims challenged here. We recognize, moreover, that our prior Mylan Decision addressed essentially the same factual inquiry centered on substantially the same asserted prior art references. We accept, therefore, Petitioner’s view that the nub of this dispute is whether “[f]our differences” set forth in the Petition overcome the shortcomings we previously identified in the Mylan Decision. Pet. 9–11; see Ex. 1011, 19–30 (Mylan Decision, including our prior analysis of essentially the same issues raised in the instant Petition).” slip op. at 23

  • Prior constructionPrior construction adoptedDecided for petitioner

    “interpreted according to their broadest reasonable construction in light of the specification of the patent in which they appear. 37 C.F.R. § 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016) (upholding the use of the broadest reasonable interpretation standard). Under that standard, we presume that a claim term carries its “ordinary and customary meaning,” which “is the meaning the term would have to a person of ordinary skill in the art in question” at the time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). Only terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). In the Mylan IPR, we determined the meaning of several claim terms of the ’680 Patent. See Ex. 1011, 15–18. The parties contend that the terms of the ’680 Patent claims should be interpreted in accord with our prior construction. See Pet. 17–18; Prelim. Resp. 19. For the reasons set forth in the Mylan Decision, we agree. See Ex. 1011, 16–18. C.” slip op. at 21

  • Skill levelOther

    “Person of Ordinary Skill in the Art. The parties propose similar, albeit non-identical, definitions of one of ordinary skill in the art, both of which are consistent with the high level of ordinary skill demonstrated by the prior art asserted in the Petition. See Pet. 16–17; Prelim. Resp. 18–19. Discerning no present conflict between the parties’ proposals, we rely on the level of ordinary skill in the art of developing and treating hormonal-dependent diseases of the breast as demonstrated by the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 20

  Claim construction§ 103 obviousnessDiscretionary denialcites KSR
  Patents in suitUS 8,329,680
• Hospira, Inc. v. Genentech, Inc.Institution denied
  PTAB · Jul 27, 2017 · IPR2017-00731 · APJ Zhenyu Yang · IPR · Institution

  Institution was denied for claims 1–14: the Baselga ’97 and Baselga ’94 ground was denied under § 325(d), and the Baselga ’96 and Baselga ’94 ground did not meet the reasonable-likelihood threshold.

  RulingsInstitution decision

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

    “In this case, in an office action dated December 7, 1999, the examiner rejected the then-pending claims as anticipated by Baselga ’97. Ex. 1011, vol. 1, 379. In response, the applicant attempted to distinguish over the reference. Id. at 398. The applicant later submitted a declaration by the inventor under 37 C.F.R. §1.131, together with certain evidence, to antedate Baselga ’97. Ex. 1011, vol. 2, 37, 118–47. In an office action dated January 9, 2001, the examiner found that neither the argument nor the declaration was persuasive. Id. at 213–14. As a result, the examiner continued to reject the claims as unpatentable over Baselga ’97. Id. at 212–14. In response, the applicant submitted another declaration by the inventor under 37 C.F.R. §1.131, accompanied by additional evidence, to antedate Baselga ’97. Id. at 230–31, 237–312. Thereafter, the examiner withdrew the rejection based on Baselga ’97, stating that “[t]he declaration filed on 5/07/2001 under 37 CFR 1.131 is sufficient to overcome the Baselga (1997).” Id. at 324. Petitioner does not present additional evidence or persuasive arguments in this proceeding for us to reach a different conclusion with respect to Baselga ’97. Under these circumstances, we exercise our discretion under § 325(d) and decline to institute inter partes review based on the combination of Baselga ’97 and Baselga ’94.” slip op. at 8

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

    “in the absence of an anthracycline derivative.” To account for this limitation, Petitioner argues that (1) the cardiotoxicity of anthracycline derivatives was well known in the prior art; (2) both preclinical and clinical studies employed the combination of an anti-ErbB2 antibody “with paclitaxel or anthracycline, not together;” and (3) Baselga ʼ94 shows that the combination with paclitaxel was superior to the combination with doxorubicin, an anthracycline derivative. Pet. 45–46. Patent Owner counters that Petitioner has not shown an ordinary artisan would have avoided anthracyclines when pursuing the combination therapy of anti- ErbB2 antibody with a taxoid. Prelim. Resp. 52. We agree with Patent Owner. Petitioner is correct that cardiotoxicity of anthracyclines was well known at the time of the ’441 patent invention. See, e.g., Ex. 1033. Yet, Petitioner concedes that “[a]nthracyclines were and remain common first-line chemotherapies for breast cancer.” Pet. 13. Thus, cardiotoxicity does not appear to have motivated an ordinary artisan to avoid anthracyclines in treating breast cancer. slip op. at 9

  • BurdenInstitution denied

    “We acknowledge that Baselga ’94 teaches a pre-clinical study using mice that combined anti-ErbB2 antibody with either paclitaxel or an anthracycline, but not the anti-ErbB2 antibody with both paclitaxel and an anthracycline. Without additional credible evidence5 or persuasive argument, however, this fact is insufficient to suggest that an ordinary artisan would have avoided anthracyclines while pursuing the combination therapy with anti-ErbB2 antibody and a taxoid in a treatment regimen for humans. As a result, based on the current record, we conclude Petitioner has 5 In the concurrently issued decision to institute trial in IPR2017-00737, we conclude that Petitioner has made a sufficient showing regarding the limitation “in the absence of an anthracycline derivative.” IPR2017-00737, Paper 17, 21–23. There, we take into consideration the disclosures of Baselga ’97 and a second prior-art reference. Id. We also find the testimony of Dr. Litton on this issue persuasive. Id. The record in the present proceeding, however, is different. As explained above, Baselga ’97 was removed from consideration as prior art for the two-drug combination treatment recited in the claims of the ’441 patent during prosecution and, as we do not revisit the antedating issue here, it is not part of our analysis. Also, the second prior art reference in IPR2017-00737 is not of record in this proceeding and Petitioner does not present persuasive expert testimony on this issue. not established a reasonable likelihood it would prevail in showing that any challenged claim would have been obvious over the teachings of Baselga ’96 and Baselga ’94.” slip op. at 10

  Discretionary denial
  Patents in suitUS 7,846,441
• Commscope Technologies, LLC v. Communications Components Antenna Inc.Rehearing denied
  PTAB · Mar 15, 2017 · IPR2016-00999 · APJ Jeffrey S Smith · IPR · Rehearing

  The Board denied rehearing, leaving in place its denial of institution for claims 1–28 because Petitioner did not show a reasonable likelihood that steered planar-array beams are necessarily asymmetrical.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “II. STANDARD OF REVIEW Under 37 C.F.R. § 42.71(c), “[w]hen rehearing a decision on petition, a panel will review the decision for an abuse of discretion.” An abuse of discretion may be determined 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 request must identify, with specificity, all matters that the moving party believes the Board misapprehended or overlooked. See 37 C.F.R. § 42.71(d). Section 42.71(d) further provides that the request must identify where each matter was previously addressed.” slip op. at 2

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

    “Lastly, Petitioner contends the Decision overlooked or “misapprehended the facts showing that all steered planar array antennas inherently result in radiation patterns having at least one asymmetrical beam.” Req. 13–15. According to Petitioner, Figure 4 of U.S. Patent No. 5,929,823 (Exhibit 2010) and Figure 3 of U.S. Patent No. 6,198,434 (Exhibit 2011), relied upon in Patent Owner’s Preliminary Response as describing remedies for distortion effects due to asymmetrical beams (Prelim. Resp. 47–48), do not eliminate the inherent asymmetry of the main beam. Req. 14. However, our Decision relies on Paragraphs 151 to 156 of Mr. Cosgrove’s testimony (Ex. 2001), which cite additional sections of Exhibits 2010 and 2011, to determine that the steered beams of a planar array are not necessarily asymmetrical. Dec. 21–23 (citing Ex. 2001 ¶¶ 151–156). For example, Mr. Cosgrove addresses the asymmetric bulge shown in Figure 4 of Exhibit 2010 by citing to a description of Figure 6, which describes a lobe symmetry of main lobe 610 that presents a more slender beam mid-section than that of main lobe 410 of Figure 4. Ex. 2001 ¶ 152 (citing Ex. 2010, 7:65–8:6). Mr. Cosgrove also addresses the asymmetric bulge shown in Figure 3 of Exhibit 2011 by citing to a description of Figure 6, which describes main lobe 610 as substantially symmetric, and more suited than lobe 310 of Figure 3 to provide communications within a defined subsection of an area to be served. Ex. 2001 ¶ 156 (citing Ex. 2011, 10:13–16). Accordingly, the Decision did not misapprehend or overlook any arguments or evidence presented by Petitioner. We did not abuse our discretion in determining that the Petitioner did not adequately establish a reasonable likelihood that a steered beam of a planar array is necessarily asymmetrical.” slip op. at 5

  None
  Patents in suitUS 8,311,582
• Fustibal LLC v. Bayer Healthcare LLCInstitution denied
  PTAB · Feb 8, 2017 · IPR2016-01490 · APJ Robert A Pollock · IPR · Institution

  The Board denied institution because Riedl was repeatedly considered during prosecution and the petition did not show a reasonable likelihood that claims 1–16 were unpatentable.

  RulingsInstitution decision

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

    “§ 314(a); 37 C.F.R. § 42.108. Our discretion on whether to institute is guided, in part, by 35 U.S.C. § 325(d), which states that “the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office.” Patent Owner requests that the Board exercise its discretion to deny institution with respect to Ground 1 because Riedl was expressly considered by the Examiner during the prosecution of the ’553 Patent. Prelim. Resp. 7–8. As noted in section I(E), above, in allowing claims 1–16 of the ’533 Patent, the Examiner expressly referred to Riedl as the closest prior art, yet found that it “fails to teach . . . the instant claimed compounds.” Ex. 2006, 913; see also Ex. 2005, 397, 569; Ex. 2006, 855 (same, with respect to similar claims).” slip op. at 11

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

    “As an initial matter, the above argument fails because, as discussed in section I(C)(iii), above, Riedl does not “expressly disclose[] the rografenib compound,” as Petitioner contends. We further agree with Patent Owner’s observation “that the Petition nowhere engages in a ‘lead compound’ analysis” and, at least with respect to Ground 2, “merely assumes—without explanation—that the POSA would select sorafenib for modification.” Prelim. Resp. 22–23. A lead compound comprises “a natural choice for further development efforts” (Altana Pharma AG v. Teva Pharm. USA, Inc., 566 F.3d 999, 1008 10 Petitioner provides similar arguments with respect to claims 1–12, 14, and 16. Id. at 22–25. (Fed. Cir. 2009)), i.e., a prior art compound “that would be most promising to modify in order to improve upon its . . . activity and obtain a compound with better activity” (Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1357 (Fed. Cir. 2007)). “In determining whether a chemist would have selected a prior art compound as a lead, the analysis is guided by evidence of the compound’s pertinent properties.” Otsuka Pharm., 678 F.3d at 1292. “Absent a reason or motivation based on such prior art evidence, mere structural similarity between a prior art compound and the claimed compound does not inform the lead compound selection.” Id. In setting forth Ground 2, Petitioner invokes a person of ordinary skill in the art “who was looking to modify sorafenib.” Prelim. Resp. 22. Neither Petitioner nor Petitioner’s expert address why a skilled artisan reading Riedl would select that compound for further development. Given that Riedl does not highlight any of the vast number of disclosed compounds as having particularly beneficial properties or present any enzymatic or biological data, we also do not discern from this reference why a person of ordinary skill in the art would have selected sorafenib as “a natural choice for further development efforts.”” slip op. at 17

  • Skill levelSkill level petitioner adoptedOther

    “Person of Ordinary Skill in the Art. Petitioner contends that a person of ordinary skill in the art “typically would have a PhD, MD, MS, or another degree relating to pharmaceutical chemistry (e.g. biology, chemistry, medicinal chemistry, medicine, pharmacology, or a closely related discipline), and . . . would have substantial familiarity, training, or experience with pharmaceutical compositions.” Pet. 6. Patent Owner has not challenged Petitioner’s proposed interpretation of a skilled artisan. We adopt Petitioner’s proposed interpretation for purposes of this opinion. See Prelim. Resp. 6 & n.1; see also Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the level of ordinary skill in the art may be evident from the prior art). B.” slip op. at 6

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

    “Petitioner (correctly) contends that the ’553 Patent expressly defines the claim term “pharmaceutically acceptable salt” as “‘a relatively non-toxic, inorganic or organic acid addition salt of a compound of the present invention.’” Pet. 7 (quoting Ex. 1001, 9:56–62). Patent Owner does not presently object to this definition. Based on the specification’s express disclosure, we agree that the cited definition applies. See Prelim. Resp. 6 & n.2. The parties agree that all other terms should be accorded their ordinary and customary meaning. Id.; Pet. 6–7. Our reviewing court counsels that only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. See Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). Accordingly, for purposes of this decision, we determine that no further construction is necessary. C.” slip op. at 7

  Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR
  Patents in suitUS 8,637,553
• Mylan Pharmaceuticals Inc. v. Astrazeneca ABInstitution denied
  PTAB · Dec 14, 2016 · IPR2016-01325 · APJ Robert A Pollock · IPR · Institution

  The Board denied institution because Mylan did not show a reasonable likelihood of proving claims 1–20 obvious over McLeskey alone or with Howell 1996.

  RulingsInstitution decision

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

    “is likely to be obvious when it does no more than yield predictable results.” Id. at 416. “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. We are, nevertheless, cautioned not to “rely on hindsight reasoning to piece together elements to arrive at the claimed invention.” In re NTP, Inc. 654 F.3d 1279, 1299 (Fed. Cir. 2011) (“Care must be taken to avoid hindsight reconstruction by using the patent in suit as a guide through the maze of prior art references, combining the right references in the right way so as to achieve the result of the claims in suit.” (internal quotations and citations omitted)). Thus, a finding of obviousness, “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.” Id. at 418 (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006). Accordingly, a party petitioning the Board for a determination of obviousness must show that “a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009) (quoting Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1361 (Fed. Cir. 2007)). D.” slip op. at 19

  • Skill levelSkill level board ownDecided for patent owner

    “Person of Ordinary Skill in the Art. The parties’ propose similar, albeit non-identical, definitions of one of ordinary skill in the art, both of which are consistent with the high level of ordinary skill demonstrated by the prior art asserted in the Petition. See Pet. 14–15; Prelim. Resp. 11–12. Discerning no present conflict between the parties’ proposals, we rely on the level of ordinary skill in the art of developing and treating hormone dependent diseases of the breast as demonstrated by the prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). B.” slip op. at 15

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

    “patentable weight, the term “therapeutically significant” should be construed to mean “any blood plasma fulvestrant concentration greater than or equal to at least 2.5 ngml-1 that is achieved for at least 4 weeks after injection.” Pet. 17–18. Patent Owner does not argue that Petitioner’s proposed interpretation is unreasonable, but contends that the meaning of the term is clear from the Specification and context of the claim phrase itself. See Prelim. Resp. 16 (citing Ex. 2003 ¶ 68; Ex. 1001, 9:24–27 (expressly defining “therapeutically significant” fulvestrant blood plasma levels as “at least 2.5 ngml-1, ideally at least 3 ngml-1, at least 8.5 ngml-1, and up to 12 12 Our reasoning extends to the wherein clauses of dependent claims 2 and 10, also challenged by Petitioner at page 16, footnote 9, of the Petition. ngml-1 of fulvestrant [] achieved in the patient.”). We agree with Patent Owner. No express construction of this term is required.” slip op. at 17

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

    “and 9, “wherein the method achieves a therapeutically significant blood plasma fulvestrant concentration of at least 2.5 ngml-1 for at least four weeks,” is merely a statement of intended result entitled to no patentable weight. Pet. 16–17. For the reasons set forth at pages 12–16 of Patent Owner’s Preliminary Response, we do not find Petitioner’s argument persuasive.12 For example, rather than merely stating the result of intramuscularly administering the recited formulation, as Petitioner argues, the wherein clause dictates both the administration duration and dose of the formulation, i.e., an amount sufficient to provide a therapeutically significant blood plasma fulvestrant concentration of at least 2.5 ngml-1 for at least four weeks. See Prelim. Resp. 15 (relying on Exhibits 2002 ¶ 37–39, Ex. 2001 ¶¶ 33–37, and citations therein). That these parameters are further limited in claims 2, 10 (“the therapeutically significant blood plasma fulvestrant concentration is at least 8.5 ngml-1”) further indicates that the wherein clauses provide defining characteristics. See Prelim. Resp. 15 (citing Ex. 2003 ¶ 60).” slip op. at 16

  Claim construction§ 103 obviousnesscites KSR
  Patents in suitUS 8,329,680
• Luye Pharma Group Ltd. / Luye Pharma(Usa) Ltd. et al. v. Alkermes Pharma Ireland Ltd. And Alkermes Controlled Therapeutics, Inc.Institution denied
  PTAB · Nov 30, 2016 · IPR2016-01095 · APJ Lora M Green · IPR · Institution

  The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–13 and 17–23 were unpatentable over Goldenheim alone or in the asserted combinations.

  RulingsInstitution decision

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

    “Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314; see 37 C.F.R. §§ 42.4, 42.108. Upon considering the Petition and the Preliminary Response, we determine that Petitioner has not demonstrated a reasonable likelihood that it would prevail in showing the unpatentability of claims 1‒13 and 17‒23. Accordingly, we decline to institute an inter partes review of those claims.” slip op. at 2

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

    “[U]nless a reference discloses within the four corners of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim, it cannot be said to prove prior invention of the thing claimed and, thus, cannot anticipate under 35 U.S.C. § 102. . . . [I]t is not enough that the prior art reference . . . includes multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008)). Here, as noted by Patent Owner, Petitioner is using disparate teachings of the Goldenheim reference to attempt to establish that the claims of the challenged patent are anticipated by that reference. The disclosure of Goldenheim of a viscosity of 35 cp in certain instances is a single sentence from that document, and Goldenheim provides no guidance as to what those circumstances may be. Petitioner has not sufficiently established that the ordinary artisan would have read that viscosity limitation into the formulation used by Example 16, which Petitioner relies upon to meet the concentration of microparticles required by challenged claim 1. In that regard, we note that Example 16 does not mention viscosity, and specifically teaches the use of an injection vehicle of 0.5% CMC and 0.1% Tween 80 in water. Ex. 1004, 52:27‒28” slip op. at 10

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

    “references remedy the deficiencies discussed above with respect to the anticipation rejection. As the Supreme Court pointed out in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” Id. at 418. Rather, the Court stated: [I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does . . . because inventions in most, if not all, instances rely upon building blocks long since uncovered, and claimed discoveries almost of necessity will be combinations of what, in some sense, is already known. Id. at 418-419 (emphasis added); see also id. at 418 (requiring a determination of “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue”) (emphasis added). In the instant proceeding, Petitioner has not provided a reason, however, as to why the ordinary artisan would have taken Goldenheim’s one mention of a viscosity of 35 cp and applied it to the formulation in Example 16 relied upon by Petitioner to meet the concentration limitation of independent challenged claim 1. Specifically, as noted by Patent Owner (Prelim. Resp. 20), Goldenheim teaches that “[i]n certain instances, the final reconstituted product viscosity may be, e.g., about 35 cps” (Ex. 1004, 35:11) but does not explain what those instances may be, much less tying that disclosure to the concentration of microparticles used in Example 16, which makes no mention of viscosity.” slip op. at 14

  § 102 anticipation§ 103 obviousnesscites KSR
  Patents in suitUS 6,667,061
• Roxane Laboratories, Inc. v. Vanda Pharmaceuticals Inc.Rehearing denied
  PTAB · Nov 4, 2016 · IPR2016-00690 · APJ Robert A Pollock · IPR · Rehearing

  The Board denied rehearing, finding no abuse of discretion in its determination that Petitioner failed to show claim 1 unpatentable because the claimed dose reduction was unpredictable.

  RulingsRehearing decision

  • RehearingRehearing, deniedDenied

    “We concluded that the record as a whole, including FDA Guidance 1999, supported a mere invitation to experiment as rejected in In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation, 676 F.3d 1063, 1073 (Fed. Cir. 2012). Dec. at 19, 22–23; see id. at 22 (“Such invitations to experiment do not, in light of the present record, predict the dosage reduction of the subject claim.”). The Decision, including our citation to Cylobenzaprine, makes clear our implicit rejection of Petitioner’s argument that, “to arrive at the claimed dosages, a POSA need only have followed FDA Guidance 1999’s comprehensive guidelines for the performance of drug interaction and dose regimen studies” using only “routine experimentation” and with “predictable results.” Pet. 54–55, 58; Reh’g Req. 4–5. Petitioner’s reliance on Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804 (Fed. Cir. 1989) and Genzyme” slip op. at 3

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

    “Unlike in Merck and Genzyme, the present case does not involve predictable results that may be confirmed or fine-tuned by routine experimentation. Rather, upon careful consideration of the asserted prior art as a whole, we determined that, “it could not be predicted whether a change in iloperidone metabolism would have increased, decreased, or had no effect on the risk of QT prolongation” and, thus, the amount of dose reduction (if any) was unpredictable and would need to be determined empirically. Dec. at 22–23 (quoting Prelim. Resp. 15–16); see also id. at 22 (stating that, “the art as a whole taught a careful evaluation of [drugs such as iloperidone] for evidence of clinically-relevant drug-drug interactions, which may or may not be addressed with dose reductions”).1 Thus, our determination rejects Petitioner’s contention that one of ordinary skill in the art would have arrived at the claimed dosage reduction by routine experimentation. See Coherus Biosciences, Inc., v. Abbvie Biotechnology LTD., Case IPR2016- 00189, slip op. at 2 (PTAB July 14, 2016) (Paper 27) (“The Board is not obligated to respond in writing to every unpersuasive argument made before it.”). Accordingly, we are not persuaded we misapprehended or overlooked any of Petitioner’s arguments.” slip op. at 4

  § 103 obviousness
  Patents in suitUS 9,138,432
• Commscope Technologies, LLC v. Communications Components Antenna Inc.Institution denied
  PTAB · Nov 3, 2016 · IPR2016-00999 · APJ Jeffrey S Smith · IPR · Institution

  The Board denied institution because the petition did not show a reasonable likelihood of proving claims 1–28 unpatentable, principally because Yea did not establish the claimed asymmetrical coverage areas.

  RulingsInstitution decision

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

    “partes review of claims 1–28 of U.S. Patent No. 8,311,582 B2 (Ex. 1001, “the ’582 patent”). Paper 1 (“Pet.”). Patent Owner, Communications Components Antenna Inc., filed a Preliminary Response. Paper 7 (“Prelim. Resp.”). Institution of an inter partes review is authorized by statute when “the information presented in the petition . . . and any response . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a); see 37 C.F.R. § 42.108. Upon consideration of the Petition and the Preliminary Response, we are not persuaded Petitioner has demonstrated a reasonable likelihood that it would prevail in establishing the unpatentability of claims 1–28 of the ’582 patent. Accordingly, we do not institute an inter partes review.” slip op. at 2

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner

    “Petitioner’s proposed construction of this limitation is supported by the specification of the ’582 patent. The ’582 patent discloses replacing a single sector coverage area with sub-sector coverage areas, at least one of which is an asymmetrical coverage area. Ex. 1001, 3:16–18. The ’582 patent discloses that the use of asymmetrical coverage areas permits the total coverage area to closely approximate the symmetrical sector coverage area being replaced, without creating excessively large sub-sector handover zones or introducing sever degradation in network performance. Id. at 3:18–24. The ’582 patent discloses creating the asymmetrical coverage areas by replacing an existing antenna with an antenna that has substantially the same coverage area, but divides the coverage area into a plurality of separate asymmetrical beams or sub-sectors. Id. at 4:32–38. As disclosed by the ’582 patent, the replacement antenna produces a plurality of separate beams, each defining a new sub-sector with only a small overlapping area between them and which together provide substantially identical coverage to the sector supported by the original antenna, to upgrade the single sector to a plurality of sub-sectors without significantly affecting neighboring sites. Id. at 4:51–57. The replacement antenna introduces asymmetry into the generated beam pattern. Id. at 4:58–60. The introduction of asymmetrical beams by the replacement antenna allows close approximation of the coverage area of the conventional sector antenna being replaced. Id. at 5:61–64. For purposes of this Decision, we adopt Petitioner’s proposed construction of “a plurality of sub-sector coverage areas extending therefrom, at least one of which is asymmetrical,” as a plurality of replacement sub-sector beams, at least one of which has an asymmetrical shape, where asymmetry includes deliberate or inherent asymmetry as the broadest reasonable construction consistent with the specification.” slip op. at 8

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

    “49 (Fed. Cir. 2005). There, the district court invalidated claims of the patent in suit on summary judgment based on the measured dimensions of a prior art patent figure. Id. at 1148. The Federal Circuit reversed, warning “that arguments based on drawings not explicitly made to scale in issued patents are unavailing.” Id. at 1149. Petitioner here does not identify any portion of Yea disclosing that Figures 4 and 8 are drawn accurately enough to determine an asymmetrical nature of the radiation patterns. Petitioner also fails to cite to any disclosure in Yea that identifies or describes an asymmetrical nature of the radiation patterns. Furthermore, Petitioner also has not explained why the shapes shown in the linear scale drawings of Figure 4 would show similar shapes when converted to a logarithmic scale. Additionally, Petitioner does not explain why the carrier to interference ratio shown in Figure 8 can be used to accurately measure antenna radiation beam patterns. We find Petitioner does not sufficiently establish that the plots shown in Figures 4 and 8 of Yea can be used to determine whether the antenna radiation beam pattern is asymmetrical. On the record before us, we determine the Petition and supporting evidence does not adequately establish a reasonable likelihood that Petitioner would prevail in showing that Yea anticipates independent claims 1, 13, and 20. b. Dependent Claims 2, 6, 7, 9, 11, 12, 14, 15, 18, 19, 21, 22, 24, and 27 Petitioner argues that Yea anticipates dependent claims 2, 6, 7, 9, 11, 12, 14, 15, 18, 19, 21, 22, 24, and 27. Pet. 47–53. In so arguing, Petitioner relies on Yea as disclosing the claimed asymmetrical coverage area. Id. Because we are not persuaded that Yea discloses this limitation, we are not persuaded that Petitioner establishes a reasonable likelihood of prevailing in showing that Yea anticipates dependent claims 2, 6, 7, 9, 11, 12, 14, 15, 18, 19, 21, 22, 24, and 27.” slip op. at 14

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

    “as well as testimony of both Mr. Collins and Mr. Cosgrove. Under Rule 37 C.F.R. § 42.108, any genuine issues of material fact created by the testimonial evidence should be viewed in light most favorable to the petitioner solely for purposes of deciding whether to institute an inter partes review. Even reviewing the testimony of Mr. Collins in the light most favorable to Petitioner, we determine Petitioner has established only that asymmetrical beams may be used in a planar array antenna, but not that a person of ordinary skill in the art would have understood steered beams of a planar array antenna are necessarily asymmetrical. Mr. Collins cites to Litva (Ex. 1009) and Wästberg (Ex. 1018) in stating that prior art steered beams of a planar array antenna can be asymmetrical beams. Ex. 1024 ¶ 179. We credit Patent Owner’s arguments and the testimony of Mr. Cosgrove to determine Petitioner does not sufficiently establish the likelihood that a person of ordinary skill in the art would have understood that steered beams of a planar array antenna are necessarily asymmetrical. Further, Petitioner fails to set forth a sufficient rationale for why a person of ordinary skill in the art would use the asymmetrical beams of the prior art with the disclosure of Yea. Pet. 39–40. On the record before us, we determine the Petition and supporting evidence does not adequately establish a reasonable likelihood that using asymmetrical beams in Yea would have been obvious. We therefore conclude that the information presented does not show a reasonable likelihood that Petitioner would prevail in showing the subject matter of claims 1, 2, 6, 7, 9, 11–15, 18–22, 24, and 27 would have been obvious over Yea, Metawave Website, Litva, and Wästberg.” slip op. at 22

  Claim construction§ 102 anticipation§ 103 obviousness
  Patents in suitUS 8,311,582
• Toyota Motor Corporation v. Signal IP, Inc.Institution denied
  PTAB · Jun 9, 2016 · IPR2016-00293 · APJ Jason J Chung · IPR · Institution

  The Board denied institution because the petition did not show a reasonable likelihood of proving claims 1, 2, and 6 obvious over either asserted combination.

  RulingsInstitution decision

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

    “inter partes review of claims 1, 2, and 6 of U.S. Patent No. 5,714,927 (Ex. 1001, “the ’927 patent”). Paper 2 (“Pet.”). In response, Patent Owner, Signal IP, Inc., filed a Preliminary Response. Paper 8 (“Prelim. Resp.”). We have jurisdiction under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . the information presented in the petition . . . shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” For the reasons set forth below, we deny institution of inter partes review of the ’927 patent.” slip op. at 2

  • Prior constructionPrior construction adoptedDecided for petitioner

    “(1) a related inter partes review (Pet. 8), and (2) a related matter before the U.S. District Court for the Central District of California (id. at 6–8). Regarding the related inter partes review, the Board previously construed the term “alert command” as raw alert data that is used to generate an alert signal, and the term “alert signal” as a signal that provides a visual or audio alert to a driver. Volkswagen Grp. of Am., Inc. v. Signal IP, Inc., Case IPR2015-00968, slip op. at 6–7 (PTAB Aug. 25, 2015), Paper 6. In order to reach our decision below, we need only construe the terms “alert command” and “alert signal.” We, therefore, decline to specifically construe any other claim terms at this time. We agree with Petitioner’s construction of the terms “alert command” and “alert signal,” consistent with our prior construction in IPR2015-00968. (See id. for our prior construction of the terms.) Thus, we construe the term “alert command” as raw alert data that is used to generate an alert signal, and the term “alert signal” as a signal that provides a visual or audio alert to a driver. Id. As explained below, even using Petitioner’s construction of these terms, Petitioner’s challenge fails to establish a reasonable likelihood that Petitioner would prevail in establishing unpatentability.” slip op. at 6

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

    “Petitioner asserts that it would have been obvious “to modify Pakett’s system such that it determines whether the ‘alert signal,’ as opposed to the ‘alert command,’ was active for a ‘threshold time’ as the claim requires.” Pet. 47. Petitioner asserts that this could be accomplished by activating a warning (alert signal) as soon as Pakett recognizes that an obstacle is present, and then applying the processing method previously applied to the persistence period instead to determine whether to sustain the warning. Id. at 47–48 (citing Ex. 1010 ¶¶ 101–04). Petitioner asserts that “one of ordinary skill in the art would consider Pakett’s delay of a warning until after the end of the persistence period to be nothing more than an optional redundancy,” and, thus, that this modification would have been obvious as “nothing more than a routine, obvious design choice.” Id. at 48 (citing Ex. 1010 ¶ 104). We disagree with Petitioner that the cited portions of Pakett’s teaching to delay the warning until after the persistence period is “nothing more than an optional redundancy,” at least because the cited portions of Packett do not indicate, either explicitly or implicitly, the 17 function of waiting for the persistence period before sending a warning to the driver indicators as optional or redundant. See id. Pakett clearly states that during the persistence period, “no warnings are sent to the driver indicators.” Ex. 1002, 6:50–51 (emphasis added). Pakett explains that waiting through the persistence period before sending warnings to the driver indicators prevents the system from incorrectly identifying stationary obstacles that were identified by the square wave generator 29 as valid obstacles in the blind spot. Id. at 7:56–63. Pakett thus explains that waiting through the persistence period before sending warnings to the driver indicators filters out false positives of objects in the blind spot of the vehicle. Id.” slip op. at 17

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 5,714,927

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.