- Minerva Surgical, Inc. v. Hologic, Inc.All claims unpatentablePTAB · May 8, 2018 · PGR2017-00002 · APJ Meredith C Petravick · PGR · Final written decision
Claims 1–19 are unpatentable under § 112(a) for lack of written description; Petitioner did not prove lack of enablement.
RulingsFinal written decision- BurdenUnpatentable
“Written Description and the ’506 Application The test for written description is an objective inquiry into the four corners of the specification from the perspective of a POSA. Using this test, the invention must be described in a manner sufficient to demonstrate that the inventor actually invented the claimed invention. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). “One shows that one is ‘in possession’ of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Written description is a question of fact judged as of the relevant filing date. Falko–Gunter Falkner v. Inglis, 448 F.3d 1357, 1363 (Fed. Cir. 2006). An ipsis verbis disclosure, however, is not necessary to satisfy the written description requirement. Vas–Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). The disclosure need only reasonably convey to a POSA that the inventor had possession of the subject matter in question, even if every nuance of the claims is not explicitly described in the specification. Id.; see Ariad, 598 F.3d at 1351.” slip op. at 23
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateUnpatentable
“Written Description and the ’506 Application The test for written description is an objective inquiry into the four corners of the specification from the perspective of a POSA. Using this test, the invention must be described in a manner sufficient to demonstrate that the inventor actually invented the claimed invention. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010). “One shows that one is ‘in possession’ of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Written description is a question of fact judged as of the relevant filing date. Falko–Gunter Falkner v. Inglis, 448 F.3d 1357, 1363 (Fed. Cir. 2006). An ipsis verbis disclosure, however, is not necessary to satisfy the written description requirement. Vas–Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). The disclosure need only reasonably convey to a POSA that the inventor had possession of the subject matter in question, even if every nuance of the claims is not explicitly described in the specification. Id.; see Ariad, 598 F.3d at 1351.” slip op. at 23
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)Not enabledNot shown unpatentable
“Under 35 U.S.C. § 112(a), enablement is separate and distinct from the written-description requirement. Ariad, 598 F.3d at 1344. “The test of enablement is whether one reasonably skilled in the art could make or use the invention from the disclosures in the patent coupled with information known in the art without undue experimentation.” United States v. Telectronics, Inc., 857 F.2d 778, 785 (Fed. Cir. 1988). “[A] patent specification complies with the statute even if a ‘reasonable’ amount of routine experimentation is required in order to practice a claimed invention.” Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1371 (Fed. Cir. 1999). Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988). These factors, referred to as the Wands factors, include: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breath of the claims. Wands, 858 F.2d at 737. It is Petitioner’s burden to show by a preponderance of the evidence that the claims of the ’989 patent lack enablement. 35 U.S.C. § 326(e). Petitioner’s evidence and argument does not sufficiently establish that the ’989 patent fails to teach those in the art to make and use the claimed invention without undue experimentation. See PO Resp. 58–66. The Petition does not address the Wands factors sufficiently so as to show that undue experimentation is required to make or use the claimed invention. For example, neither the Petition nor Dr. Pearce sufficiently addresses the state of the prior art or the relative skill of those in the art. See Pet. 64–65; Ex. 1002 ¶¶ 145–152; PO Resp. 62. As Patent Owner argues, this is an “omission[] that [is] particularly fatal” to Petitioner’s enablement argument, because Petitioner argues that mechanical expansion and inflation expansion are incompatible and cannot be combined. PO Resp. 62; see Pet. 30–38, 64. Dr. Grundfest, however, testifies that it was well known to combine mechanical and balloon-based expansion in surgical devices. Ex. 2005 ¶¶ 132–136; PO Resp. 56. During cross-examination, Dr. Pearce testified that he “thought about the state-of-the-art in minimally invasive surgery during the 1990s.” Ex. 2003 18:1–14. Dr. Pearce’s testimony is conclusory and does not sufficiently address whether he considered whether it was well known to combine mechanical expansion and inflation expansion in surgical devices. For another example, relying upon the testimony of Dr. Pearce, the Petition asserts that a redesign of the expansion design disclosed in the ’989 patent “would take a substantial amount of time and cost to achieve.” Pet. 65 (citing Ex. 1002 ¶ 149). Likewise, Dr. Pearce testifies, “[s]uch a redesign would take a substantial amount of time and cost to achieve.” Ex. 1002 ¶ 149. Dr. Pearce, however, does not explain sufficiently why combining mechanical expansion and inflation expansion would require a substantial amount of time and cost. See id. For these reasons, we determine that Petitioner has not met its burden of showing by a preponderance of evidence that claims 1–19 are unpatentable under 35 U.S.C. § 112(a) for lack of enablement.” slip op. at 33
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Factors that may be considered in determining level of ordinary skill in the art include: (1) the educational level of the inventor; (2) type of problems encountered in the art; (3) prior art solutions to those problems; (4) rapidity with which innovations are made; (5) sophistication of the technology; and (6) educational level of active workers in the field. Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007) (quoting Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983)). We are not persuaded that Dr. Pearce’s testimony concerning the level of skill in the art is erroneous to the extent it does not explicitly require experience related to devices used for uterine surgical procedures or surgical devices that employ expandable inflation-based and mechanical-based components. Patent Owner’s argument and Dr. Grundfest’s testimony is inconsistent with the ’989 patent, which does not disclose an ablation device or method of using an ablation device that solves problems unique to endometrial ablation or unique to surgical devices that employ expandable inflation-based and mechanical-based components. The ’989 patent does not limit the art to be “the field of minimally invasive surgical and uterine devices” (Ex. 2005 ¶ 60). The ’989 patent states: “The present invention relates generally to the field of apparatuses and methods for ablating or coagulating the interior surfaces of body organs. Specifically, it relates to an apparatus and method for ablating the interior linings of body organs such as the uterus and gallbladder.” Ex. 1001, 1:20–24; see also id. at 2:36–38 (“The present invention is an apparatus and method of ablation and/or coagulating tissue, such as that of the uterus or other organ”).” slip op. at 16
Patent outcomesUS 9,247,989 unpatentable§ 112 disclosurePatents in suitUS 9,247,989
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.