- Mylan Pharmaceuticals Inc. v. Astrazeneca ABInstitution deniedPTAB · 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 KSRPatents 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 deniedPTAB · 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 KSRPatents in suitUS 6,667,061 - Roxane Laboratories, Inc. v. Vanda Pharmaceuticals Inc.Rehearing deniedPTAB · 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 obviousnessPatents in suitUS 9,138,432 - PTAB · Aug 30, 2016 · IPR2014-01448 · APJ Debra K Stephens · IPR · Rehearing
The Board denied rehearing of its final written decision, leaving claims 1 and 7 unpatentable over He and Korodi under § 103.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“decision should be modified, and “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d).” slip op. at 4
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73, concluding Petitioner had shown by a preponderance of the evidence that the challenged claims are unpatentable. Specifically, we determined Petitioner had established by a preponderance of the evidence claims 1 and 7 are unpatentable under 35 U.S.C. § 103(a) over He and Korodi (Final Dec. 11–25). In light of our determination that Petitioner had established by a preponderance of the evidence that claims 1 and 7 of the ’279 Patent are unpatentable under 35 U.S.C. § 103(a) as obvious over He and Korodi, we took no position on whether the same claims are also obvious over the combination of the teachings and suggestions of Gustafsson and He (id. at 25).” slip op. at 3
§ 103 obviousnessPatents in suitUS 7,671,279 - Praxair Distribution, Inc. v. Mallinckrodt Hospital Products IP Ltd.Some claims unpatentablePTAB · Jul 7, 2016 · IPR2015-00529 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–8 and 10–19 are unpatentable as obvious over the INOmax label, Bernasconi, Loh, and Goyal; claims 1, 7, 12, and 14 are also anticipated and obvious over the INOmax label.
RulingsFinal written decision- Expert testimonyOther
“method of providing pharmaceutically acceptable nitric oxide gas requires providing information to the medical provider to safely administer the nitric oxide gas,” thus “confirm[ing] that the ‘providing . . . information’ step is functionally related to the steps in the claimed method.” PO Resp. 31–33. As an initial matter, whether the claims should be interpreted as requiring such a functional relationship is a legal conclusion. See PO Resp. 13. Patent Owner’s conclusion regarding functional relationship between claim terms is based, at least in part, on an overly-limited reading of “pharmaceutically acceptable nitric oxide gas,” as discussed above. See PO Resp. 27. Further, we do not read the transcript testimony relied on by Patent Owner as clearly admitting a functional relationship between the steps of “providing pharmaceutically acceptable nitric oxide gas” and the information of (ii). See PO Resp. 31–32 (citing Ex. 2022, 78:15–80:4, 81:11–22, 111:2–17)). To the contrary, Dr. Beghetti appears to have testified that the claim elements are not directly related. Ex. 2022, 86:10– 25. Although Patent Owner points to In re Distefano, 808 F.3d at 848, as evidence that a “printed matter analysis includes ‘factual findings’” (PO Sur Reply 4, n.6), which inform the ultimate legal conclusion, we do not find the evidence as a whole compelling.” slip op. at 19
- ExcludeMotion to exclude, deniedOther
“IV. PETITIONER’S MOTION TO EXCLUDE Petitioner moves to exclude certain portions of Ex. 2024 on the grounds that they “are declarations and supporting materials submitted during patent examination . . . in violation of 37 C.F.R. § 42.53(a)” and “lack foundation (FRE 602) and authentication (FRE 901) and constitute impermissible hearsay (FRE 901).” Paper 31, 2–3. Petitioner likewise moves to exclude Exhibit 2029 as not relied on in the Patent Owner Response or by Patent Owner’s expert. Id. at 3. As we do not rely on the objected-to materials in this opinion, we dismiss the motion as moot.” slip op. at 45
- Strike new argumentNew argument disregardedOther
“V. OBJECTIONS TO DEMONSTRATIVES The parties also submit competing objections to demonstrative exhibits used at trial. Papers 46, 47. Specifically, both parties object to certain slides as setting forth a new argument not previously made in any paper. Papers 46, 47. The parties are reminded that demonstrative exhibits are illustrative only and are not part of the trial record. Indeed, in accordance with our Order on requests for oral argument, neither party filed its demonstratives with the Board. See Paper 45, 2 (“Notwithstanding 37 C.F.R. § 42.70(b), the parties shall not file any demonstrative exhibits in this proceeding without prior authorization from the Board. 37 C.F.R. § 42.5(b). Demonstrative exhibits are intended to be visual aids to assist a party in making its oral presentation and will not be entered into the record of these proceedings.”). Nevertheless, in this Final Written Decision, we rely on the arguments presented properly in the parties’ briefs and the evidence of record and do not consider any new arguments not previously set forth in any paper. See Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14, 2012). (“No new evidence or arguments may be presented at the oral argument.”).” slip op. at 45
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“The Applicant amended the preamble of the rejected independent claims to recite “[a] method of providing pharmaceutically acceptable nitric oxide gas,” as presently set forth in claims 1 and 7. Id. at 746–747. Subsequent to the amendment, the Examiner withdrew the objection. Id. at 765; see id. at 733 (“If all the priority issues are resolved then it appears that the primary reference in the 103 rejection will no longer be prior art.” (italics omitted)). On pages 19 and 20 of its Response, Patent Owner argues that the preamble is, therefore, limiting in light of Catalina Mktg. International, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002), which holds that “clear reliance on the preamble during prosecution to distinguish the claimed invention from the prior art transforms the preamble into a claim limitation because such reliance indicates the use of the preamble to define, in part, the claimed invention.” Although the prosecution history shows that amendment of the preamble only indirectly distinguished the claims over the prior art by establishing an earlier priority date, we conclude that both the Applicant and the Examiner treated the preamble as a claim limitation. Accordingly, we agree with Patent Owner that the preamble language “pharmaceutically acceptable nitric oxide gas” is limiting.” slip op. at 11
Patent outcomesUS 8,846,112 mixedClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 8,846,112 - Par Pharmaceutical, Inc. v. Novartis AGRehearing deniedPTAB · Jun 30, 2016 · IPR2016-00084 · APJ Christopher L Crumbley · IPR · Rehearing
The Board denied Novartis’s rehearing request, leaving institution in place for claims 1–3 and 8–10 because it had not abused its discretion.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“review trial, the Board “will review the decision for an abuse of discretion.” 37 C.F.R. § 42.71(c). “An abuse of discretion occurs where the decision is based on an erroneous interpretation of the law, on factual findings that are not supported by substantial evidence, or represents an unreasonable judgment in weighing relevant factors.” Lacavera v. Dudas, 441 F.3d 1380, 1383 (Fed. Cir. 2006) (citing Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005)). The party requesting rehearing has the burden of showing the decision should be modified, and “[t]he request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We did not overlook this argument in reaching our decision to institute trial. While Novartis’ argument raises an issue of fact to be considered at trial, it does not directly refute the testimony of Par’s expert, Dr. Jorgensen, who relies on Lemke’s Table 16-1 for a slightly different purpose. Dr. Jorgensen testifies that a person of ordinary skill in the art would understand, based on Lemke, that alcohol, phenol, amine, carboxylic acid, ester, and amide groups have the greatest solubilizing potential in a polyfunctional molecule. Ex. 1003 ¶ 83. Because, according to Dr. Jorgensen, some of these groups have known drawbacks, he concluded that a person of ordinary skill in the art seeking to improve solubility would have had reason to modify rapamycin to add amino, hydroxyl, or carboxylate groups. Id. ¶¶ 83–84. Contrary to Novartis’ argument, Dr. Jorgensen did not rely on the exact figures of Table 16-1; this may be appropriate, given the fact that Lemke reports the figures as “predictions.” Ex. 1008, 115. The parties will have the opportunity to explore this issue further during trial.” slip op. at 4
NonePatents in suitUS 5,665,772 - Great West Casualty Company / Bitco General Insurance Corporation et al. v. Intellectual Ventures II LLCInstitution deniedPTAB · Jun 9, 2016 · IPR2016-00453 · APJ Michael W Kim · IPR · Institution
The Board denied institution on claims 11–20, exercising discretion under § 314(a) because this was an unjustified serial petition and separately rejecting it under § 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Institution denied general plasticDenied
“patent, using substantially the same prior art, and filed so long apart that Petitioner received the benefit of having studied Patent Owner’s Preliminary Response in an earlier petition. That is especially so if Petitioner, at the time of filing of the earlier petition was aware of or should have been aware of the prior art references newly cited and applied in the later petition. To that end, Petitioner does not assert that it was unaware of Nazem prior to filing the instant Petition or any earlier petition. The potential inequity based on a petitioner’s filing of serial and similar attacks against the same claims of the same patent, while having the opportunity to adjust litigation positions along the way based on either patent owner’s contentions responding to prior challenges or the Board’s decision on prior challenges, is real and cannot be ignored. This is not to say, however, that multiple petitions against the same claims of the same patent are never permitted. Rather, each case depends on its own facts. We look to and consider, in each case, as we do here, what rationale a petitioner offers for filing multiple petitions and for the time elapsed between those filings. Generally, however, we are unpersuaded that the possibility of an adverse claim construction alone, especially where the possibility of the adverse claim construction was expressly a result of assertions made by a patent owner in the previous proceeding, is sufficient to justify serial petitions.” slip op. at 9
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Emphasis added. As admitted by Petitioner, all of the grounds in the instant Petition and the petition in IPR2015-01706 rely primarily on MyLibrary. Furthermore, the only reference cited additionally in the instant proceeding is Nazem, and Nazem mentions, on multiple occasions, variations of “MyYahoo” or “my.yahoo.com.” Ex. 1047, Figs. 1, 3, 4, 5A, 5B; 2:63-3:2; Appendices A and B. Moreover, Petitioner asserts the following: For example, one such prior art personalized portal, referenced by MyLibrary as an inspiration, was the MyYahoo system, Ex. 1005 at 1, a system described in U.S. Patent No. 5,983,227 to Nazem et al. (issued Nov. 9, 1999) (Ex. 1047). Ex. 1047 at Face, Fig. 5a (“MyYahoo!”). Pet. 21. A person having ordinary skill in the art would have been motivated to add content, such as disclosed in Nazem, to the personalized web pages of MyLibrary because MyYahoo was an inspiration for the system of MyLibrary, thereby suggesting the additional MyYahoo functionality would work well with MyLibrary. Pet. 22. Given these articulated connections between the substance of MyLibrary and Nazem, we have no trouble determining that presenting MyLibrary and Nazem in this proceeding is “the same or substantially the same prior art or arguments” as was presented previously to the Office in IPR2015-01706, with MyLibrary alone.” slip op. at 13
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied
“III. CONCLUSION For the foregoing reasons, we exercise discretion not to institute inter partes review of any of claims 11–20 of the ’177 patent, and also reject the Petition under 35 U.S.C. § 325(d). IV. ORDER It is ORDERED that no trial or inter partes review is instituted for any claim of the ’177 patent on any ground in this proceeding.” slip op. at 14
Discretionary denialPatents in suitUS 7,516,177 - Zimmer Biomet Holdings, Inc. / Zimmer Inc. et al. v. Advanced Orthopaedic Solutions, Inc.Institution deniedPTAB · Jun 7, 2016 · IPR2016-00311 · APJ Lora M Green · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood that claims 6–11, 13–15, 19, and 20 were unpatentable over the asserted grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“We have jurisdiction under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon considering the Petition and the Preliminary Response, we determine that Petitioner has failed to demonstrate a reasonable likelihood that it would prevail in showing the unpatentability of any of the challenged claims. Accordingly, we decline to institute an inter partes review.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We agree with Patent Owner that Petitioner has not sufficiently established that Shavit discloses an insert having a lower surface that is operative to contact a bone screw. Petitioner relies primarily on Figures 1B and 4 of Shavit to establish that the insert contacts the bone screw. As noted by Patent Owner (Prelim. Resp. 16), “[i]t is well established that patent drawings do not define the precise proportions of the elements and may not be relied on to show particular sizes if the specification is completely silent on the issue.” Hockerson-Halberstadt, Inc. v. Avia Group Int’l Inc., 222 F.3d 951, 956 (Fed. Cir. 2000). “Ordinarily drawings which accompany an application for a patent are merely illustrative of the principles embodied in the alleged invention claimed therein and do not define the precise proportions of elements relied upon to endow the claims with patentability.” In re Olson, 212 F.2d 590, 592 (CCPA 1954).” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableNot shown unpatentable
“In challenging claim 19 over the combination of Shavit and Kilpela, as to the limitation that “said lower surface [of an insert] operative to engage a bone screw extending through said aperture,” Petitioner states that for the reasons discussed as to claim 8, Shavit in view of Kilpela renders that limitation obvious. Pet. 37 (emphasis added). Petitioner relies on that same analysis as to the challenge of claim 19 over the combination of Shavit, Kilpela, and Bramlet. Id. at 46. In its discussion of claim 8 as being obvious over the combination of Shavit and Kilpela, Petitioner relies on Kilpela for a reason to have a longitudinal passageway through the insert. Id. at 28. As to the remaining limitations of claim 8, which depends from claim 6, Petitioner relies on its discussion of claim 6 as being anticipated by Shavit. Id. Petitioner, therefore, does not rely on either Kilpela or Bramlet to make up the deficiency of Shavit as discussed above as to the anticipation challenge of independent claim 6. Thus, for the reasons discussed above in Section II.B.ii.a, we determine that Petitioner has not sufficiently established that claim 19 is rendered by the combination of Shavit and Kilpela, or the combination of Shavit, Kilpela, and Bramlet. Similarly, Petitioner relies on its discussion of independent claims 6, 13, and 19 in contending that claim 8 is rendered obvious by the combination of Shavit and Kilpela (Pet. 28), that claims 14, 15, and 20 are rendered obvious by the combination of Shavit and Kilpela (Pet. 31–33, 39– 40) or by the combination of Shavit, Kilpela, and Bramlet (Pet. 40–45, 47), and that claim 11 is rendered obvious by the combination of Shavit and Bramlet (Pet. 47–48). As Petitioner again does not rely on either Kilpela or Bramlet to remedy the above discussed deficiency of Shavit, we determine also that Petitioner has not sufficiently established that claims 8, 11, 14, 15, and 20 are rendered by the Shavit in combination with Kilpela and/or Bramlet.” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“We determine that, for purposes of this Decision, none of the terms in the challenged claims require express construction at this time. See, e.g. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 3 Bramlet et al., US Patent No. 6,443,954 B1, issued Sep. 3, 2002 (Ex. 1007) (“Bramlet”). 1999) (noting that only claim terms that are in controversy need to be construed, and then only to the extent necessary to resolve the controversy).” slip op. at 8
Claim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 8,092,454 - Par Pharmaceutical, Inc. v. Novartis AGInstitution deniedPTAB · 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 obviousnessPatents in suitUS 6,455,518 - Neptune Generics, LLC v. Nektar TherapeuticsInstitution deniedPTAB · Apr 27, 2016 · IPR2016-00049 · APJ Lora M Green · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claims 1–4 were anticipated by Bentley or obvious over Bentley, Erez, and Ouchi.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“We have jurisdiction under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 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 claims 1–4. Accordingly, we decline to institute an inter partes review of those claims.” slip op. at 2
- BurdenNot shown unpatentable
“We agree with Patent Owner. That is, Petitioner has not demonstrated that “the size of [the] Bentley genus ‘depends solely on the number’ of monomer units in the PEG moiety.” Prelim. Resp. 25 (quoting Pet. 26–27). Petitioner fails to demonstrate why the ordinary artisan would immediately envisage Formula V of Bentley in which AO is the configuration of Formula Ia, the linkage is a simple ether linkage, and having the required number of monomer units in the PEG moiety. See In re Arkley, 455 F.2d 586, 587 (CCPA 1972) (noting that an anticipatory reference under 35 U.S.C. § 102 “must clearly and unequivocally disclose the claimed compound or direct those skilled in the art to the compound without any need for picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference.”).” slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We agree with Patent Owner. That is, Petitioner has not demonstrated that “the size of [the] Bentley genus ‘depends solely on the number’ of monomer units in the PEG moiety.” Prelim. Resp. 25 (quoting Pet. 26–27). Petitioner fails to demonstrate why the ordinary artisan would immediately envisage Formula V of Bentley in which AO is the configuration of Formula Ia, the linkage is a simple ether linkage, and having the required number of monomer units in the PEG moiety. See In re Arkley, 455 F.2d 586, 587 (CCPA 1972) (noting that an anticipatory reference under 35 U.S.C. § 102 “must clearly and unequivocally disclose the claimed compound or direct those skilled in the art to the compound without any need for picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference.”).” slip op. at 14
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“We do not disagree with Petitioner that the challenged claims are encompassed by the genus of Bentley, and that all the components of the compounds recited by the challenged claims are also known. To establish the claims are obvious, however, Petitioner must also identify a reason that would have led a person of ordinary skill in the art to combine the elements of Bentley, Ouchi, and Erez in the manner specified by the claims. See KSR, 550 U.S. at 418 (“[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.”); see also id. (“[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.”). Specifically, assuming that Formula V of Bentley, i.e., R-POLY-X- AO, is the proper starting point, Bentley teaches that “[i]n a preferred embodiment, R is methoxy, POLY is poly(ethylene glycol), X is a hydrolytically stable linkage such as amide, amine, carbamate, sulfide, ether, thioether, or urea, and AO has the structure shown in Formula Ia or Formula Ib above.” Ex. 1003 ¶¶ 113–114. Petitioner has failed provide a reason, with rational underpinning, why the ordinary artisan would have picked the conjugate of Ia, combined with a simple ether linkage, and use the required number of monomer units in the PEG moiety to arrive at the compound of the challenged claims.” slip op. at 20
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,786,133
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.