- Initiative For Medicines, Access & Knowledge (I-Mak), Inc. v. Gilead Pharmasset LLCInstitution deniedPTAB · Jun 13, 2018 · IPR2018-00103 · APJ Lora M Green · IPR · Institution
The Board denied institution for claims 1–19 because the Petition did not show a reasonable likelihood that any challenged claim was anticipated by Klecker or Sommadossi, or obvious over Sommadossi and Klecker.
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. 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 any of the challenged claims. Accordingly, we decline to institute an inter partes review for any challenged claim of the ’572 patent.” slip op. at 2
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“reasonable likelihood that claim 1 is anticipated by Klecker. To anticipate a reference must expressly or inherently disclose “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.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (2008). Moreover, “anticipation is not proven by ‘multiple, distinct teachings that the artisan might somehow combine to achieve the claimed invention.’” Microsoft Corp. v. Biscotti, Inc., 878 F.3d 1052, 1069 (Fed. Cir. 2017) (internal citation omitted). “[A] disclosed genus may anticipate a claimed species when the genus is so small that one of ordinary skill in the art would ‘at once envisage each member of this limited class.’” Wasica Fin. GmbH v. Continental Auto. Sys., Inc., 853 F.3d 1272, 1285 (Fed. Cir. 2017) (quoting AbbVie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Tr., 764 F.3d 1366, 1379 (Fed. Cir. 2014)). In this case, we agree with Patent Owner that Petitioner is improperly using claim 1 as a roadmap to cherry pick teachings of the Klecker reference to arrive at compounds encompassed by the genus of that claim. For example, we acknowledge that Klecker teaches that a fluorine may be placed below the ring at the 2' position of the sugar ring. Ex. 1005, 19:25‒26. Petitioner does not point us to any teaching of Klecker, however, that teaches a compound that has both a methyl group and a fluorine at the 2' position of the sugar ring, regardless of whether the fluorine is in the up position or the down position. That is, although the broad genus of compounds disclosed by Klecker encompasses such compounds, Petitioner does not point us to any teaching, other than the broad disclosure of the genus, wherein “W, X, Y, [and] Z” may be “H, hydroxy, halogen, alkyl (C1- C6), alkoxy (C1-C6)a label containing moiety or a label” (Ex. 1005, 15:3‒5), that would direct the ordinary artisan to choose X and W such that one of X and W is methyl and the other is fluorine, much less pointing to support of X as fluorine and W as methyl.” slip op. at 11
- Expert testimonyPetitioner expert discountedDecided for patent owner
“Petitioner relies on the Declaration of Dr. Fortunak in asserting that because Klecker teaches the X position may be substituted with fluorine and teaches that W can be an alkyl (C1 – C6), the ordinary artisan would understand from “general knowledge and common sense that methyl is a preferred lower alkyl in that group.” Pet. 34 (citing Ex. 1002 ¶ 92). Dr. Fortunak, however, merely repeats the statement in the Petition without citing any evidentiary support. See Ex. 1002 ¶ 92; see also id. ¶¶ 93‒95 (discussing choosing other substituents in the structure of Klecker). Conclusory statements by an expert “that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.” 37 C.F.R. § 42.65(a). Furthermore, Petitioner’s conclusory statements (Pet. 34‒35) that because C is the first substituent identified for J, and H and OH are the first two substituents identified for Y and Z and, thus, the ordinary artisan would immediately envisage a compound where J is C, Y is H, and Z is OH, do not sufficiently persuade us that the ordinary artisan would immediately envisage their implementation to arrive at compounds that fall within the genus of claim 1.” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable
“To the extent that Petitioner (Pet. 51‒52) is invoking inherency in arguing that the express teaching of Sommadossi that R7 may be chloro, 6 Britton et al., U.S. Patent 5,420,266, issued May 30, 1995 (Ex. 1011). bromo and iodo, is also an express teaching that R7 may be fluoro, we disagree that the use of fluoro as the R7 group is inherent in the teachings of Sommadossi. “Inherency . . . may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999), quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981). Even though the ordinary artisan may have understood that fluoro is also a halogen and may be substituted for chloro, bromo, or iodo, the fact remains that Sommadossi taught the use of, inter alia, chloro, bromo, or iodo at the R7 position, specifically, rather than a halogen element, generally. Ex. 1006, 13:24‒27. Petitioner’s argument (Pet. 52) that “Sommadossi taught that R6 could be ‘chloro, bromo, fluoro, [or] iodo,’” is actually counter to Petitioner’s assertions. That is, that statement demonstrates that Sommadossi knew that “fluoro” could be included in the list of halogens. Moreover, Sommadossi defined the term “halo” as “chloro, bromo, iodo, and fluoro.” Ex. 1006, 52:31. Thus, to avoid inadvertently excluding a halogen, Sommadossi could have used the term “halo” in listing the possible substituents for the R7 group, but chose not to do so. Accordingly, we determine that Petitioner has not sufficiently established that Sommadossi anticipates the compounds of claim 1. Because, as discussed above in our analysis of the anticipation ground over Klecker, all of the claims require the compound of that claim, or a particular compound that falls within the genus of claim 1, Petitioner has also not sufficiently demonstrated that any of the challenged claims are anticipated by Sommadossi. Accordingly, we decline to institute trial as to any of the challenged claims on the basis that the claim is anticipated by Sommadossi.” slip op. at 17
§ 102 anticipation§ 103 obviousnessPatents in suitUS 7,429,572 - Teoxane S.A. v. Allergan, PLC Et Al.Institution deniedPTAB · Mar 9, 2018 · IPR2017-01906 · APJ Grace Karaffa Obermann · IPR · Institution
The Board denied institution because the Petition did not show a reasonable likelihood of prevailing on any challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“We have authority to determine whether to institute an inter partes review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). An inter partes review may be instituted only upon a showing 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). Taking account of the information presented, we determine that the Petition fails to make out that threshold showing for review. Accordingly, we deny the Petition and decline to institute a trial.” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“printed publication” that was “sufficiently accessible to the public interested in the art” before the critical date. In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989). The touchstone of public accessibility is whether an ordinary artisan “exercising reasonable diligence” would have been able to locate the document prior to the critical date. SRI Int’l, Inc. v. Internet Sec. Sys., Inc., 511 F.3d 1186, 1194 (Fed. Cir. 2008). Petitioner availed itself of two opportunities to make out that showing, but has not done so adequately. See Pet. 4, 14; Reply 1–5. slip op. at 11
- Strike new argumentNew argument disregardedDecided for patent owner
“favored providing Petitioner an opportunity to respond to the evidence, presented in the Preliminary Response, which undercuts the Petition’s bare attorney argument that the Elevess Summary qualifies as a printed publication. Paper 11 (providing Petitioner an opportunity to file a Reply and Patent Owner to file a Sur- Reply on that issue). In the Reply, however, Petitioner abandons the evidence presented in the Petition, does not address the evidence presented in the Preliminary Response, and instead advances an entirely new theory of public accessibility. Reply 1–5 (citing Exs. 1067, 1068, 1069, and 1070). Petitioner’s Reply to the Preliminary Response is not the proper place to raise such information, which should have been presented in the Petition. Because the argument and evidence presented in the Reply exceeds the scope of a proper reply, we have discretion to exclude it. 37 C.F.R. § 42.23(b) (“A reply may only respond to arguments raised in the corresponding opposition or patent owner response.”).” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable
“in claim 1 requiring a composition “wherein the lidocaine is freely released in vivo” (after injection in a patient). Ex. 1001 19:31. On that point, we agree with Patent Owner that the Petition fails to address adequately how the presence of HI in Hunter’s composition would affect the free release of lidocaine from the HA gel in vivo. See Pet. 20–21; Prelim. Resp. 14–15 (pointing out that the Petition includes no showing that the lidocaine in Hunter’s composition “would necessarily be ‘freely released’ in vivo” where Hunter discloses “very different compositions” that include both “hyaluronic acid and an inhibitory compound” that “can inhibit the activity of hyaluronidase” (quoting Ex. 1004, 11)).” slip op. at 17
§ 102 anticipation§ 103 obviousnessPatents in suitUS 8,357,795 - Amneal Pharmaceuticals, LLC v. Purdue Pharma L.P., The P.F. Laboratories, Inc., And Purdue Pharmaceuticals L.P.All claims unpatentablePTAB · Feb 8, 2018 · IPR2016-01412 · APJ Christopher G Paulraj · IPR · Final written decision
Claims 1–13 and 16–19 are unpatentable as obvious over Palermo, Joshi, and Handbook, and over Oshlack, Joshi, Handbook, and Doyon.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“’976 patent would have “a degree in one or more fields of medicine, chemical engineering, chemistry, pharmaceutical science, polymer chemistry, pharmaceutics, pharmaceutical technology, pharmacokinetics, and/or pharmacology, and/or a number of years of industry training or experience in one or more of those fields.” Pet. 15 (citing Ex.1007 ¶¶ 31– 34). Patent Owner agrees with Petitioner’s proposed level of skill in the art. PO Resp. 24 (citing Ex. 2001 ¶¶ 74–75). We, therefore, apply that skill level in our analysis, with the understanding that the level of skill is also reflected in the prior art of record. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“We find Petitioner’s proposed construction to be more persuasive based on the ’376 patent specification. In particular, the specification defines “unsuitable for injection” “to mean that one would have substantial difficulty injecting the dosage form (e.g., due to pain upon administration or difficulty pushing the dosage form through a syringe) due to the viscosity imparted on the dosage form, thereby reducing the potential for abuse of the opioid analgesic from the dosage form.” Ex. 1001, 3:15–20. Additionally, in an example concerning the formation of a gel at different concentrations, the specification characterizes certain solutions as “THICK (10 cP to 60 cP): Although a syringe can be filled with this solution, it was hard to do.” Id. at 32:8–24, Table 3. Thus, the specification teaches that a viscosity of at least 10 cP is difficult to pull into a syringe or administer parenterally (via injection). Patent Owner does not address these teachings of the specification. We, therefore, determine that the broadest reasonable interpretation of “unsuitable for parenteral administration” and “unsuitable to pull into an insulin syringe” encompasses a gelling agent that imparts a viscosity of at least 10 cP.” slip op. at 10
- PTAB / AIA Trials › §315(e) estoppelEstoppel appliesDecided for petitioner
“articulated a four-factor test in determining whether collateral estoppel attaches: “(1) the identity of the issues in a prior proceeding; (2) the issues were actually litigated; (3) the determination of the issues was necessary to the resulting judgment; and (4) the party defending against preclusion had a full and fair opportunity to litigate the issues.” Levi Strauss & Co. v. Abercrombie & Fitch Trading Co., 719 F.3d 1367, 1371 (Fed. Cir. 2013). Collateral estoppel can attach in proceedings before the Office for identical issues that were addressed with respect to a different patent during prior district court litigation. See In re Arunachalam, No. 2016-1607, 2017 WL 4387224, at *2–4 (Fed. Cir. Oct. 3, 2017) (“In light of Dr. Arunachalam’s previous opportunity to litigate the validity of the asserted claims of the ’500 Patent, which contain the [same] terms . . . , we see no reason to allow her to appeal the patentability of the challenged claims of the ’556 Patent, which also contain the same critical terms.”). All four factors for collateral estoppel are met here. With regard to the first factor, the issue of Joshi’s status as prior art is identical for both proceedings. The ’376 patent is part of the same chain of continuity as the ’888 patent, and both patents share the same specification and claim priority to the same non-provisional application filed August 6, 2002 and provisional application filed August 6, 2001. As such, to the extent Joshi qualifies as prior art to the ’888 patent, it would also qualify as prior art to the ’376 patent.” slip op. at 16
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateWritten description inadequateNot shown unpatentable
“Although the statements above encompass “mixtures” of HPMC and PEO among a myriad of other possibilities for the gelling agent, we find no basis to conclude that the inventors of the ’376 patent were in possession of the specifically claimed formulation from such a broad disclosure.11 The 10 The April 25th draft application is heavily redacted and we thus cannot discern what other materials were specifically contemplated as “thickening agents” by that time. See Ex. 2091, 5. However, given the nature and amount of the redactions and Patent Owner’s assertion that the draft application ultimately led to the filing of the ’534 provisional with the broad disclosure set forth above, we find it reasonable to conclude that additional materials were included in the draft application. Moreover, the draft application was forwarded as part of an email from Patent Owner’s attorney, which “[e]nclosed the latest draft of the tamper resistant application.” Ex. 2091. As such, there is no evidence to suggest that the list of thickening agents included as part of the draft application originated from the inventors as opposed to patent counsel. 11 We recognize that the same broad disclosure with a “laundry list” of possible gelling agents is found in the specification of the ’376 patent. See Federal Circuit has held that such “laundry list” disclosures are insufficient to satisfy the written description requirement when there is no further guidance (“blazemarks”) provided about which species or combination of species included as part of the list may be selected to arrive at the claimed invention. See Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996). Not having specifically named or mentioned the combination in any manner, “one is left to select[] from the myriads of possibilities encompassed by the broad disclosure, with no guide indicating or directing that this particular selection should be made rather than any of the many others which could also be made.” In re Ruschig, 379 F.2d 990, 995 (CCPA 1967); see also Los Angeles Biomedical Research Inst. at Harbor-UCLA Med. Ctr. v. Eli Lilly & Co., 849 F.3d 1049, 1057 (Fed. Cir. 2017) (“To satisfy the written description requirement, the disclosure in each application must ‘reasonably convey[ ]’ to those skilled in the art that as of the claimed priority date the inventor was in possession of the later claimed subject matter.”) (citing Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991)). Other evidence of record further supports our conclusion that the inventors of the ’376 patent had not conceived of or reduced to practice the claimed formulation prior to Joshi’s August 30, 2001 filing date. In his Declaration, inventor Benjamin Oshlack attests that Patent Owner’s laboratory scientists focused on “testing the syringeability of various concentration solutions of pectin, sodium alginate, and sodium acrylate, as well as combinations of pectin and sodium alginate” between January 4 and Ex. 1001, 6:46–62. We, however, do not address the issue of written description support for any of the subsequently filed applications. 17, 2001. Ex. 2081 ¶ 22. Additionally, Mr. Oshlack attests that the scientists had evaluated “xanthan gum, carrageenan, and locust bean gum (and combinations thereof) as gelling agents, between April 5 and 12, 2001.” Id. ¶ 23. None of the laboratory notebook excerpts proffered by Patent Owner mention a combination of HPMC and PEO as gelling agents to be used in an oxycodone formulation. Exs. 2087–2090. Consistent with the testing actually done, the working examples set forth in the ’534 provisional (as well as in the ’376 patent) focus on xantham gum, pectin, microcrystalline cellulose, and hydroxyethlcellulose as the gelling agents. See Ex. 1026, 44– 49 (Examples 1–5). We find, therefore, that the inventors did not particularly consider either PEO or HPMC, let alone both PEO and HPMC in combination, when evaluating possible gelling agents for an abuse-deterrent formulation of oxycodone. Accordingly, because we find that the ’376 patent is not entitled to a filing date earlier than August 6, 2002, we further determine that Joshi qualifies as § 102(e) prior art as of that date. Having determined that Joshi qualifies as prior art, we turn to the merits of Petitioner’s patentability challenges.” slip op. at 21
Patent outcomesUS 9,034,376 unpatentableClaim construction§ 103 obviousness§ 112 disclosurePatents in suitUS 9,034,376 - PTAB · Jan 11, 2018 · IPR2016-01102 · APJ Christopher L Crumbley · IPR · Rehearing
Petitioners’ rehearing requests concerning joinder of claim 7 were dismissed as moot because claim 1 was not proven unpatentable and claim 7’s grounds depended on claim 1.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“A party dissatisfied with a decision of the Board may file a request for rehearing. 37 C.F.R. § 42.71(d). 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.” Id.” slip op. at 2
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingNot reached
“7 of the ’772 patent, which depends from claim 1 that is at issue in the instituted inter partes review IPR2016-00084. In our Decision denying joinder of claim 7, we determined that the joinder Petitions had established a reasonable likelihood of prevailing as to claim 7, based on Petitioners’ unpatentability arguments as to claim 1 made in IPR2016-00084. IPR2016- 01059, Paper 19, 10–12. Nevertheless, we declined to exercise our discretion to grant joinder. Id. at 15–18. It is of this latter determination that Petitioners request rehearing.” slip op. at 2
NonePatents in suitUS 5,665,772 - PTAB · Jan 11, 2018 · IPR2016-01059 · APJ Christopher L Crumbley · IPR · Rehearing
The Board dismissed Petitioners’ rehearing requests as moot because claim 1 was not proven unpatentable and no separate unpatentability ground was advanced for claim 7.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“A party dissatisfied with a decision of the Board may file a request for rehearing. 37 C.F.R. § 42.71(d). 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.” Id.” slip op. at 2
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingNot reached
“7 of the ’772 patent, which depends from claim 1 that is at issue in the instituted inter partes review IPR2016-00084. In our Decision denying joinder of claim 7, we determined that the joinder Petitions had established a reasonable likelihood of prevailing as to claim 7, based on Petitioners’ unpatentability arguments as to claim 1 made in IPR2016-00084. IPR2016- 01059, Paper 19, 10–12. Nevertheless, we declined to exercise our discretion to grant joinder. Id. at 15–18. It is of this latter determination that Petitioners request rehearing.” slip op. at 2
NonePatents in suitUS 5,665,772 - PTAB · Jan 11, 2018 · IPR2016-01103 · APJ Christopher L Crumbley · IPR · Rehearing
The Board dismissed Petitioners’ rehearing requests as moot because claim 1 was not proven unpatentable, leaving no basis to find dependent claim 7 separately unpatentable.
RulingsRehearing decision- RehearingRehearing, deniedOther
“A party dissatisfied with a decision of the Board may file a request for rehearing. 37 C.F.R. § 42.71(d). 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.” Id.” slip op. at 2
- PTAB / AIA Trials › Joinder §315(c) / SAS all-or-nothingNot reached
“7 of the ’772 patent, which depends from claim 1 that is at issue in the instituted inter partes review IPR2016-00084. In our Decision denying joinder of claim 7, we determined that the joinder Petitions had established a reasonable likelihood of prevailing as to claim 7, based on Petitioners’ unpatentability arguments as to claim 1 made in IPR2016-00084. IPR2016- 01059, Paper 19, 10–12. Nevertheless, we declined to exercise our discretion to grant joinder. Id. at 15–18. It is of this latter determination that Petitioners request rehearing.” slip op. at 2
NonePatents in suitUS 5,665,772 - Par Pharmaceutical, Inc. / Breckenridge Pharmaceutical, Inc. et al. v. Novartis AGNo claims unpatentablePTAB · Jan 11, 2018 · IPR2016-00084 · APJ Christopher L Crumbley · IPR · Final written decision
Claims 1–3 and 8–10 were not proven unpatentable because the proposed obviousness analysis did not show that the choices leading to everolimus were finite, small, or easily traversed.
RulingsFinal written decision- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“The facts of the case at hand provide a stark contrast. As we have found above, while the prior art recognized rapamycin as a promising immunosuppressant, it was only one among many possible lead compounds. Furthermore, the prior art shows that chemists were pursuing a number of avenues to increase solubility, including making derivatives but also other approaches such as formulation techniques or prodrugs. And most tellingly, in contrast to Bristol-Myers Squibb where the experts agreed on the type and location of the potential substituents, here the experts diverge significantly. As discussed above, we credit the testimony of Novartis’ experts over Par’s, and find that the options of substituent and substituent position would not have been as narrow as those proposed by Par. In sum, we find that the person of ordinary skill in the art at the time the invention was made would have been faced with a large number of decision points along the lead compound analysis proposed by Par. The number of potential compounds encompassed by this decision tree is unclear, but would be far larger than the three compounds Dr. Jorgensen discusses. Only by making the “right” choice at each step would the skilled artisan arrive at everolimus, the compound of claim 10 and the basis of Par’s obviousness challenge. In light of these facts, we cannot conclude that the options faced would have been—in the words of the Federal Circuit—finite, small, or easily traversed. We, therefore, cannot conclude that the compound of claim 10, and by extension, the compounds of claims 1–3, would have been obvious to one of skill in the art as of October 1992.” slip op. at 35
- Skill levelSkill level petitioner adoptedOther
“Par contends, supported by the testimony of Dr. Jorgensen, that a person of ordinary skill in the art at the time of the invention would generally have a Ph.D. in organic chemistry or medicinal chemistry or physical chemistry or a related field, or a Masters or Bachelor degree in chemistry or a related field and at least three years’ experience in drug discovery and design. Pet. 16 (citing Ex. 1003 ¶ 45). Novartis’ experts, with insubstantial exceptions, agree with Dr. Jorgensen’s recitation. Ex. 2092 ¶ 22 (Klibanov); Ex. 2093 ¶¶ 47–48 (Roush). We adopt the level of skill recited by the parties for purposes of our analysis herein.” slip op. at 13
- Expert testimonyPetitioner expert discountedPatent owner expert creditedDecided for patent owner
“Based on our review of the entirety of the record, we cannot conclude, as Par contends, that the C40 hydroxyl group would be the obvious, optimal, or preferred location for substitutions to rapamycin. Dr. Jorgensen’s testimony to that effect is premised on his assertion that a person of ordinary skill in the art would have first narrowed the group of possible substitution positions to the C10, C28, or C40, because those are the hydroxyl groups of rapamycin. Ex. 1003 ¶ 142 (“person of ordinary skill in the art would have focused on hydroxyl groups on rapamycin as initial targets for modification.”). This statement, however, is based only on Dr. Jorgensen’s statement that the reactions of hydroxyl groups are “among the most fundamental and elementary reactions taught in beginning organic chemistry courses.” Id. Dr. Jorgensen provides no objective, documentary evidence that would indicate that starting with hydroxyl groups was an accepted rule followed by medicinal chemists in the field. To the contrary, Dr. Roush testifies that Dr. Jorgensen’s focus on rapamycin’s hydroxyl groups is inconsistent with the prior art as a whole, and provides multiple citations to the documentary evidence in the record supporting his testimony. Ex. 2093 ¶¶ 197, 206–216 (citing prior art modifications at the C9, C26, C27, C28, and C32 positions). For example, Ondeyka14 discloses demethylation of the methoxy group at rapamycin’s C29 position, while Caulfield15 discloses oxime substitutions at C32.16 We have weighed the testimony of Drs. Jorgensen and Roush on this point, and find Dr. Roush’s to be the more credible. While we agree with Par that a person of ordinary skill in the art would have considered rapamycin’s C40 position as a candidate for substitution, that site must be evaluated as one potential substitution site among many that were being modified in the field at the time of the invention.” slip op. at 24
- Obviousness (§103) › Objective indicia / secondary considerationsNot reached
“obviousness challenge. In light of these facts, we cannot conclude that the options faced would have been—in the words of the Federal Circuit—finite, small, or easily traversed. We, therefore, cannot conclude that the compound of claim 10, and by extension, the compounds of claims 1–3, would have been obvious to one of skill in the art as of October 1992. With respect to the second ground of unpatentability, pertaining to the method of treatment claims 8 and 9, Par’s obviousness arguments are premised on the conclusion that everolimus would have been obvious. See Pet. 48–51 (“claims 8 and 9 would have been obvious to a person of ordinary skill in the art in view of the art that makes the 40-O-2- hydroxyethyl-rapamycin derivative obvious”). As we conclude that everolimus has not been shown to be obvious, we reach the same conclusion as to the methods of claims 8 and 9. The addition of Hughes to the ground of unpatentability does not provide any of the teachings we found lacking from the art asserted in the first ground of unpatentability. As we have concluded that Par’s articulated lead compound analysis is insufficient to establish the obviousness of any of the challenged claims, we need not reach, and do not evaluate, the objective indicia of obviousness submitted by Novartis. PO Resp. 60–68.” slip op. at 36
Patent outcomesUS 5,665,772 not shown unpatentable§ 103 obviousnessPatents in suitUS 5,665,772 - CSL Behring GmbH / CSL Behring LLC v. Shire Viropharma Inc.Institution deniedPTAB · Dec 7, 2017 · IPR2017-01512 · APJ Lora M Green · IPR · Institution
Institution was denied for claims 1-18: Schranz was not shown to be prior art, and the Jiang ground was denied under §325(d) because the same art and arguments were previously presented.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“may request to cancel . . . claims of a patent only on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” Before considering the ground before us based on Schranz, we must address whether Petitioner has provided a sufficient threshold showing that Schranz constitutes prior art under 35 U.S.C. § 102—a legal question based on underlying factual determinations. Panduit Corp. v. Dennison Mfg. Co., 810 F.2d 1561, 1568” slip op. at 6
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication not establishedNot shown unpatentable
“As was the case in Dep’t of Justice, the use of a joint declaration “invites innumerable practical difficulties in cross-examining the witnesses, in assessing the reliability of the statements made, and in evaluating the weight to be accorded to the opinions expressed.” Dep’t of Justice 10. For example, Dr. Machnig and Mr. Waldhauser declare in “our recollection.” Ex. 1013-A ¶ 4. It is unclear how two different declarants can have the same “recollection.” In addition, the declarants state that “[h]andouts of the poster . . . [were] picked up by us.” Id. ¶ 5. It is unclear from the Joint Declaration, however, if both declarants were together when the hand-out was picked-up, or if each declarant picked up the handout at separate times. We, therefore, afford the Joint Declaration of Dr. Machnig and Mr. Waldhauser little weight. See Dep’t of Justice 11. As it is the primary evidence on which Petitioner relies to demonstrate that Schranz is prior art, we determine that Petitioner has not made a threshold showing that Schranz is prior art to the ’111 patent. As Petitioner has not sufficiently demonstrated that Schranz is prior art to the ’111 patent, we determine that the Petition does not demonstrate a reasonable likelihood that challenged claims 1‒18 are rendered obvious by the combination of Schranz (as evidenced by Cinryze Label and Bock), Gatlin, Pharming, and Levi.” slip op. at 9
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“In the instant proceeding, we agree with Patent Owner that Petitioner is essentially making the same arguments as to obviousness over Jiang that the Examiner already considered. The prosecution history demonstrates that the Examiner considered many of the same issues with respect to the Schranz Declaration as Petitioner is arguing here. Although the Examiner noted in allowing the claims that Applicant Shire had established the secondary consideration of long-felt need and failure of others, the Examiner also stated that the art did not suggest the claimed dosage. We determine, therefore, that the Examiner did address the Schranz Declaration, and the Examiner’s concerns are similar to those raised by Petitioner in the instant proceeding. That is, as the Examiner stated: The Examiner has considered the arguments found in Dr. Schranz’s declaration concerning difficulty in higher concentration formulation. However, Dr. Schranz’s declaration provides little more than an assertion that it is difficult to reach such a concentration formulation, as opposed to actual evidence establishing that this (1) was a recognized problem in the art and (2) was generally not achievable via other means. Ex. 1001-B, 3041. Thus, the Examiner did acknowledge the lack of supporting evidence in the Schranz Declaration demonstrating that it was difficult to reach the claimed concentration.” slip op. at 13
- Expert testimonyPetitioner expert discountedDecided for patent owner
“As was the case in Dep’t of Justice, the use of a joint declaration “invites innumerable practical difficulties in cross-examining the witnesses, in assessing the reliability of the statements made, and in evaluating the weight to be accorded to the opinions expressed.” Dep’t of Justice 10. For example, Dr. Machnig and Mr. Waldhauser declare in “our recollection.” Ex. 1013-A ¶ 4. It is unclear how two different declarants can have the same “recollection.” In addition, the declarants state that “[h]andouts of the poster . . . [were] picked up by us.” Id. ¶ 5. It is unclear from the Joint Declaration, however, if both declarants were together when the hand-out was picked-up, or if each declarant picked up the handout at separate times. We, therefore, afford the Joint Declaration of Dr. Machnig and Mr. Waldhauser little weight. See Dep’t of Justice 11. As it is the primary evidence on which Petitioner relies to demonstrate that Schranz is prior art, we determine that Petitioner has not made a threshold showing that Schranz is prior art to the ’111 patent. As Petitioner has not sufficiently demonstrated that Schranz is prior art to the ’111 patent, we determine that the Petition does not demonstrate a reasonable likelihood that challenged claims 1‒18 are rendered obvious by the combination of Schranz (as evidenced by Cinryze Label and Bock), Gatlin, Pharming, and Levi.” slip op. at 9
§ 102 anticipationDiscretionary denialPatents in suitUS 9,616,111 - Luye Pharma Group Ltd. / Luye Pharma(Usa) Ltd. et al. v. Alkermes Pharma Ireland Ltd.No claims unpatentablePTAB · 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 unpatentableClaim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 6,667,061 - PTAB · Nov 3, 2017 · IPR2016-00452 · APJ Michelle N Ankenbrand · IPR · Rehearing
The Board denied Daikin’s rehearing request, leaving in place its finding that claims 1–4, 7, and 8 were not shown unpatentable over Miller and the ARI Standard.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“STANDARD OF REVIEW A request for rehearing “must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, or a reply.” 37 C.F.R. § 42.71(d). The party challenging a decision bears the burden of showing that the decision should be modified. Id.” slip op. at 2
- ExcludeOther
“exclude all of Dr. Sun’s experiments. Paper 32. In the Motion, Petitioner urged us to exclude Dr. Sun’s experiments 1–4 from the record “because they are irrelevant to any ground upon which trial was instituted and include[] information whose probative value (if any) is substantially outweighed by a danger of confusing the issues.” Id. at 2 (emphasis added) (citing Paper 23 ¶ 6). Petitioner continued: “the compounds HCFC-123 and HFC-236ea that were used in Experiments 1–4 are not relevant to the issues in this trial. These compounds were not used in [Miller’s example 1].” Id. (citing Ex. 1066 ¶¶ 65–68). In reply to the Motion to Exclude, Petitioner further argued that Dr. Sun’s experiments 1–4 demonstrate that “HCFC-123 and HFC-236ea behave completely differently from HFC-245cb.” Paper 37, 2 (emphasis added). Petitioner made those same arguments in the Reply to Patent Owner’s Response. Reply 12–14. As we explained in the Final Decision (Final Dec. 21–22), and reiterate here, Petitioner’s reliance on Dr. Sun’s experiments 1–4, and the results thereof, is inconsistent with Petitioner’s arguments that Dr. Sun’s experiments 1–4 are irrelevant, prejudicial, and should be excluded from the record. Petitioner’s arguments to the contrary in the Request for Rehearing express mere disagreement with our determination in the Final Decision and weighing of the evidence. As we explain above, a request for rehearing is not an opportunity to reargue positions with which we disagreed in our Final Decision.” slip op. at 8
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“Petitioner”) filed a Request for Rehearing (Paper 43, “Reh’g Req.”) of the Final Written Decision (Paper 42, “Final Decision” or “Final Dec.”), in which we concluded that Petitioner did not show by a preponderance of the evidence that claims 1–4, 7, and 8 of U.S. Patent No. 8,147,709 B2 (Ex. 1001, “the ’709 patent”) are unpatentable under 35 U.S.C. § 103(a) over the combination of Miller1 and the ARI Standard.2 slip op. at 2
§ 103 obviousnessPatents in suitUS 8,147,709
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.