- Eli Lilly And Company. v. Los Angeles Biomedical Research Institute At Harbor-Ucla Medical CenterAll claims unpatentablePTAB · Oct 22, 2015 · IPR2014-00752 · APJ Lora M Green · IPR · Final written decision
Claims 1–5 are unpatentable under § 103 over Montorsi, Whitaker, and Porst because their combination renders the claimed method obvious.
RulingsFinal written decision- Skill levelOther
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“Lederman, 355 F.3d 1343, 1348 (Fed. Cir. 2004); see 35 U.S.C. § 120. “In order to satisfy the written description requirement, the disclosure as originally filed does not have to provide in haec verba support for the claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). Nonetheless, the disclosure must convey with reasonable clarity to those skilled in the art that the inventor was in possession of the invention. Id. “Put another way, one skilled in the art, reading the original disclosure, must immediately discern the limitation at issue in the claims.” Id. However, “the question [of adequate written description] is not whether a claimed invention is an obvious variant of that which is disclosed in the specification.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997); see also Tronzo v. Biomet Inc., 156 F.3d 1154, 1158 (Fed. Cir. 1998) (“A disclosure in a parent application that merely renders the later-claimed invention obvious is not sufficient to meet the written description requirement; the disclosure must describe the claimed invention with all its limitations.”).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner
“1257 (Fed. Cir. 2007). “[A] claim construction analysis must begin and remain centered on the claim language itself, for that is the language the patentee has chosen to ‘particularly point[ ] out and distinctly claim[ ] the subject matter which the patentee regards as his invention.’” Innova/Pure Water, Inc. v. Safari Water Filtration Sys,, Inc., 381 F.3d 1111, 1116 (Fed. Cir. 2004); see also Pitney Bowes, Inc. v. Hewlett–Packard Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999) (“The starting point for any claim construction must be the claims themselves.”). Only terms which are in controversy need to be construed, and then 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). 1. “continuous long-term regimen” In the Decision on Institution, we interpreted this claim phrase as: the administration of drug over a certain period of time without intermission such that the treatment is therapeutically effective. With regard to claims of the ’903 patent, the time period is not less than 45 days, as recited in claim 1.” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“2. “an individual with at least one of penile tunical fibrosis and corporal tissue fibrosis” Patent Owner contends that the term “should be construed to mean ‘an individual with fibrosis of either the tunica albuginea or corpora cavernosa of the penis, in which the fibrosis is clinically significant.’” PO Resp. 22 (emphasis removed). In particular, Patent Owner contends that “a person of ordinary skill in the art would understand the claims of the ’903 patent to concern treatment of penile fibrosis, a disease.” Id. According to Patent Owner, Petitioner’s proposed interpretation of a patient having any degree of fibrosis “risks encompassing not only men with subclinical penile fibrosis, but men with no penile fibrosis at all.” Id. at 22–23. Petitioner responds that the term “clinically significant” “is largely subjective—what is clinically significant to one patient or doctor may not be clinically significant to another.” Reply 11. The ’903 patent teaches that there is a need “to treat and/or ameliorate the symptoms of a variety of fibrotic disease, such as PD, ED and arteriosclerosis.” Ex. 1001, 2:42–46. Thus, although the claim requires the patient to have penile tunical fibrosis or corporal tissue fibrosis, we conclude that the broadest reasonable interpretation of “an individual with at least one of penile tunical fibrosis and corporal tissue fibrosis,” in view of the Specification of the ’903 patent, requires that the individual have symptoms that may be associated with penile fibrosis, such as ED, but not that the patient be specifically diagnosed as having penile tunical fibrosis or corporal tissue fibrosis.” slip op. at 7
Patent outcomesUS 8,133,903 unpatentableClaim construction§ 103 obviousness§ 112 disclosurePatents in suitUS 8,133,903 - Medtronic, Inc. v. Nuvasive, Inc.All claims unpatentablePTAB · Apr 3, 2015 · IPR2014-00073 · APJ Francisco C Prats · IPR · Final written decision
Claims 21, 22, 24, 30, and 33–37 are unpatentable under four § 103 grounds; the two grounds relying on Branch and Blewett fail because Blewett is not prior art.
RulingsFinal written decision- BurdenDecided for petitioner
“We conclude that Petitioner has proved by a preponderance of the evidence that claims 21, 22, 24, 30, and 33–37 of the ʼ356 patent are unpatentable, based on some, but not all, of the grounds upon which trial was instituted.” slip op. at 4
- Skill levelOther
“As to the level of ordinary skill in the pertinent art, the parties, as discussed below, challenge their opposing experts’ conclusions and qualifications. Nonetheless, neither party asserts specifically that the ultimate conclusion of obviousness turns on adoption of a particular level of ordinary skill. In that regard, the parties’ experts advance slightly different opinions as to the level of ordinary skill in the pertinent art. See Ex. 1015 ¶ 11 (Watkins Decl.)); Ex. 2020 ¶ 17 (Phillips Decl.). Both experts, nonetheless, generally agree that an ordinarily skilled artisan at the critical time would have been either an experienced spinal surgeon, or an experienced engineer or professional involved in the implementation or design of surgical instruments for use in spinal surgery, with significant access to orthopedic or neurosurgeons. See id. When evaluating the parties’ contentions regarding the scope and content of the prior art, and the differences between the prior art and the challenged claims, we take into consideration both parties’ assertions regarding the level of ordinary skill. We note also that the level of ordinary skill in the art may be evidenced by the cited references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001).” slip op. at 14
- Expert testimonyPatent owner expert creditedPetitioner expert discountedOther
“Having reviewed the ’214 application, including the cited figures, in light of Patent Owner’s contentions and Dr. Phillips’s testimony, we find that the evidence supports Patent Owner’s assertion that an ordinarily skilled artisan would have understood that the ’214 application described a system for accessing a spinal disc of a lumbar spine, the system including a blade holder apparatus configured to releasably lock with a plurality of retractor blades, as claim 21 of the ’356 patent requires. Because that element is the sole feature of claim 21 urged by Petitioner as being absent from the ’214 application, we find also that the evidence does not support Petitioner’s assertion that claim 21 of the ’356 patent is not entitled to the benefit of the ’214 application’s filing date. Petitioner’s arguments do not persuade us to the contrary. It might be true, as Petitioner argues (Reply 15 (citing Ex. 1024 ¶¶ 29–30 (Watkins Reply Decl.))), that the cited figures of the ’214 application do not depict a hexagonal shape or threading that would have indicated the locking elements were nuts or bolts. Petitioner does not adequately explain, however, why the absence of such depictions demonstrates that Dr. Phillips erroneously characterized those elements. As to Dr. Phillips’s testimony on cross examination that he did not see a nut in Figure 28 of the ’214 application (Reply 15 (citing Ex. 1038, 206:9–207:9 (Phillips Deposition)), we note that on redirect examination he stated that he actually did see a nut-and-bolt structure in Figure 28A. Ex. 1038, 208. Moreover, the fact that Dr. Phillips might have misinterpreted one structure in one figure does not persuade us that he erroneously characterized the overall disclosure of the ’214 application, including the several other figures which he referred to in his testimony.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for patent owner
“A. Claim Construction The Board interprets claims using the “broadest reasonable construction in light of the specification of the patent in which [they] appear[].” 37 C.F.R. § 42.100(b); In re Cuozzo Speed Techs., LLC, No. 2014-1301, 2015 WL 448667, at *5–*7 (Fed. Cir. Feb. 4, 2015). Under that standard, claim terms are given their ordinary and customary meaning, as would be understood by one of ordinary skill in the art in the context of the entire disclosure. See In re Translogic Tech. Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). In the Decision to Institute we concluded that the recitations in claim 21 regarding the “lateral trans-psoas path to the lumbar spine” relate to an intended use of the claimed apparatus. Dec. 8. Accordingly, we attributed to those intended use recitations no particular structural limitations, beyond an ability to be used in, or follow, a trans-psoas path in the manner recited in the claim. Id. Neither party disputes that claim construction and we maintain it in light of the record developed during trial. No other terms require express construction for purposes of this Decision.” slip op. at 7
Patent outcomesUS 8,192,356 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 8,192,356 - PTAB · May 20, 2014 · IPR2013-00124 · APJ Lora M Green · IPR · Final written decision
The Board granted cancellation of claims 1-26 and allowed substitute claims 27-44, but denied substitute claim 45 as unpatentable over Behan.
RulingsFinal written decision- ScopeMotion to amend, grantedGranted
“patent claims. 35 U.S.C. § 316(d)(3); 37 C.F.R. § 42.121(a)(2)(ii).” slip op. at 9
- Disclosure Requirements (§112) › Written description (Ariad)Written description adequateDecided for patent owner
“partes review must set forth “[t]he support in the original disclosure of the patent for each claim that is added or amended.”” slip op. at 10
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundMixed
“In order to establish a prima facie case of obviousness based on structural similarity, the prior art must provide a reason to make the claimed compound, and there must also be “„adequate support in the prior art‟ for the 7 P.E.A. Teal et al., (Z)-11-Hexadecen-1-ol: A Behavioral Modifying Chemical Present in the Pheromone Gland of Female Heliothis Zea (Lepidoptera:Noctuidae), 116 CAN. ENTOMOLOGY 777-79 (1984). Ex. 2003. 8 Yih-Shen Hwang et al., Structure-Activity Relationship of Unsaturated Fatty Acids as Mosquito Ovipositional Repellents, 10 J. OF CHEM. ECOLOGY 145-51 (1984). Ex. 2004. change in structure.” Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1356 (Fed. Cir. 2007) (quoting In re Grabiak, 769 F.2d 729, 731-32 (Fed. Cir. 1985)). The United States Court of Appeals for the Federal Circuit noted that the test for obviousness of a compound based on structural similarity is in accordance with the legal principles enunciated by the Supreme Court in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), specifically, that it is 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‟ in an obviousness determination.” Takeda, 492 F.3d at 1356-57 (quoting KSR, 550 U.S. at 418). Thus, “in cases involving new chemical compounds, it remains necessary to identify some reason that would have led a chemist to modify a known compound in a particular manner to establish prima facie obviousness of a new claimed compound.” Takeda, 492 F.3d at 1357.” slip op. at 14
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundDecided for petitioner
“We acknowledge that McMahon and the Zhang Declaration are evidence that the ordinary artisan would not have had a reasonable expectation that, because a compound is known to repel mosquitoes, such as Aedes aegypti, the compound would also repel ticks, such as Amblyomma variegatum. Claim 45, however, encompasses the use of isolongifolanone when R1 is a hydrogen atom and R2 is an oxygen atom, which is the same compound specifically taught by Behan. See Pet. 7-8 (showing the structure of isolongifolanone, and discussing how it is encompassed by the chemical formula set forth in claim 1). As discussed above, Behan teaches the use of isolongifolanone to repel mosquitoes or cockroaches. Patent Owner provides no evidence that ticks and mites would not be present on the same objects or areas where mosquitoes and cockroaches are found, which are the insects addressed by Behan. Thus, by applying the isolongifolanone taught by Behan to an object or airspace for the purpose of repelling mosquitoes or cockroaches, one would also inherently repel ticks and mites. “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990); see also Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377-78 (Fed. Cir. 2005) (noting that the realization of a new benefit of an old process does not render that process patentable); Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001) (stating in the context of a claimed process that was drawn to the same use comprising the same steps of the prior art, “[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.”). We, therefore, conclude that the preponderance of the evidence does not support the patentability of proposed claim 45.” slip op. at 17
§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSRPatents in suitUS 7,579,016
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