Ex Parte Brandt et al

Patent Trials and Appeals BoardFeb 28, 2019

14317848 - (D) (P.T.A.B. Feb. 28, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/317,848 06/27/2014 23517 7590 03/04/2019 MORGAN, LEWIS & BOCKIUS LLP (BO) 1111 PENNSYLVANIA A VENUE, N.W. WASHINGTON, DC 20004 UNITED ST A TES OF AMERICA FIRST NAMED INVENTOR William Andrew Brandt UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www .uspto.gov ATTORNEY DOCKET NO. CONFIRMATION NO. RPN-033/7316442001 9413 EXAMINER OSINSKI, BRADLEY JAMES ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 03/04/2019 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): kcatalano@morganlewis.com patents@morganlewis.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte WILLIAM ANDREW BRANDT, JILIAN KA VAZOV, DAVID MATHEW WESSEL, and ANDREW DUNN Appeal 2018-003766 Application 14/317,848 Technology Center 3700 Before ANNETTE R. REIMERS, JEFFREY A. STEPHENS, and ALYSSA A. FINAMORE, Administrative Patent Judges. REIMERS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE William Andrew Brandt et al. ("Appellants") appeal under 35 U.S.C. Â§ 134(a) from the Examiner's decision to reject under 35 U.S.C. Â§ 103 claims 1-15. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We AFFIRM. Appeal 2018-003766 Application 14/317 ,848 CLAIMED SUBJECT MATTER The claimed subject matter relates to "an implantable device for administering a liquid." Spec. ,r 7, Figs. 1-3. Claim 1, the sole independent claim on appeal, is representative of the claimed subject matter and recites: 1. An implantable device for administering a liquid, the device comprising: an outer shell defining an interior volume; within the interior volume, a pump assembly including a reservoir having an inner shell, a gas-driven forcing mechanism and a passage for conducting liquid from the reservoir to an ejection site outside the shell in response to pressure applied by the forcing mechanism; and a refill port assembly comprising: an orifice through a surface of the outer shell for receiving a refill needle; a first housing defining a first chamber having first and second open ends and fluidly coupled, via at least one bore through the first housing, to a ventable interior portion, the ventable interior portion having boundaries defined by the outer and inner shells; a second housing defining a second chamber having an open end and fluidly coupled, via at least one bore through the second housing, to the drug reservoir; and first and second needle-penetrable septums, wherein the orifice, the first and second housings and the first and second septums are arranged in series with the first septum disposed between, and penetrably sealing, the orifice and the first open end of the first housing, and the second septum disposed between, and penetrably sealing, the second open end of the first housing and the open end of the second housing. 2 Appeal 2018-003766 Application 14/317 ,848 REJECTIONS I. Claims 1, 5-8, 14, and 15 stand rejected under 35 U.S.C. Â§ 103 as unpatentable over Enegren (US 4,955,861, issued Sept. 11, 1990) and Fischell (US 4,571,749, issued Feb. 25, 1986). II. Claims 2 and 9 stand rejected under 35 U.S.C. Â§ 103 as unpatentable over Enegren, Fischell, and Gibson (US 2003/0050626 Al, published Mar. 13, 2003). III. Claim 3 stands rejected under 35 U.S.C. Â§ 103 as unpatentable over Enegren, Fischell, and Giebmeyer (US 2005/0015076 Al, published Jan. 20, 2005). IV. Claims 4, 10, and 12 stand rejected under 35 U.S.C. Â§ 103 as unpatentable over Enegren, Fischell, and McEntee (US 6,648,853 Bl, issued Nov. 18, 2003). V. Claim 11 stands rejected under 35 U.S.C. Â§ 103 as unpatentable over Enegren, Fischell, and Nelson (US 6,013,051, issued Jan. 11, 2000). VI. Claim 13 stands rejected under 35 U.S.C. Â§ 103 as unpatentable over Enegren, Fischell, 1 and Idriss (US 5,176,641, issued Jan. 5, 1993). 1 The Fischell reference is omitted in the header of this rejection. See Non- Final Office Action 8 ("Non-Final Act."), dated Jan. 12, 2017. Because claim 13 depends from claim 1 (Appeal Brief 13 ("Appeal Br."), Claims Appendix ("Claims App."), filed Sept. 7, 2017), and because the Examiner refers to claim 1 in the rejection of claim 13 (see Non-Final Act. 8), we understand this rejection to rely on Fischell as well. 3 Appeal 2018-003766 Application 14/317 ,848 ANALYSIS Obviousness over Enegren and Fischel! Claims 1, 5---8, 14, and 15 Appellants do not present arguments for claims 5-8, 14, and 15 separate from those presented for claim 1. See Appeal Br. 5-10. We select claim 1 as the representative claim, and claims 5-8, 14, and 15 stand or fall with claim 1. 37 C.F.R. Â§ 4I.37(c)(l)(iv). Independent claim 1 is directed to an implantable device including a refill port assembly having "a first housing defining a first chamber having first and second open ends and fluidly coupled, via at least one bore through the first housing, to a ventable interior portion, the ventable interior portion having boundaries defined by ... outer and inner shells." Appeal Br. 11, Claims App. The Examiner finds although Enegren substantially discloses the implantable device as claimed, including an interior portion 28 having boundaries defined by outer and inner shells, Enegren "does not disclose the first housing fluidly coupled, via at least one bore through the first housing, to the interior portion, and the interior portion being ventable." Non-Final Act. 2-3. The Examiner finds "Fischell discloses a refill port assembly similar to that of Enegren, but [Fischell] includes three housings so that the pressure inside the system may be adjusted." Id. at 3, 9 ("Fischell is used in a similar way [ to Enegren] but [Fischell] discloses the chamber is accessible and ventable only as part of adjustment in the event the pressure inside the chamber is too high or too low."); Fischell 9:56-10:6. The Examiner concludes it would have been obvious to modify the first housing of Enegren by adding an additional chamber and septum, which is fluidly coupled to interior portion 28 ofEnegren to allow a user to adjust the pressure within 4 Appeal 2018-003766 Application 14/317 ,848 interior portion 28, as taught by Fischell, in the event the pressure within interior portion 28 is too high or too low. See Non-Final Act. 4, 9-10; see also Ans. 8-11. 2 Appellants contend: [I]f Enegren's compartment 42 (which the Examiner equates to the recited first chamber) were fluidly coupled to the interior chamber 28 (which the Examiner equates to the recited ventable interior portion) as proposed, injection of the infusate from Enegren's needle into the compartment 42 would mean that the infusate necessarily enters the interior chamber 28. Appeal Br. 6-7; id. at 7 ("[F]luidly coupling Enegren's interior chamber 28 to the compartment 42 would deleteriously mix the infusate with the two- phase fluid."). In the Answer, the Examiner clarifies it was "never suggested [by the Examiner to] fluidly coupl[e] chamber 42 and interior portion 28." Ans. 9. Rather, the Examiner "stated it would have been obvious to add an additional chamber and septum [to Enegren] which would be fluidicly coupled to interior portion 28"; thus, in the Examiner's proposed modification of Enegren, "the infusate of chamber 42 and delivery path 74 would not mix with the two-phase fluid of the new chamber and interior portion 28." Ans. 9; see also id. (The Examiner "stated it would have been obvious to add another septum and chamber to Enegren as taught by Fischell, this new chamber is the claimed first chamber. The [E]xaminer never stated chamber 42 would be placed into communication with interior portion 28."); Non-Final Act. 4. 2 Examiner's Answer ("Ans."), dated Dec. 22, 2017. 5 Appeal 2018-003766 Application 14/317 ,848 Appellants contend "an additional chamber would cause the proposed configuration to fall outside claim 1, which requires the ventable interior portion to be fluidly coupled to the first chamber." Appeal Br. 7 ( emphasis omitted). However, the Examiner points out "there is no claim language preventing another chamber [in Enegren ], nor is the [E]xaminer required to interpret chamber 42 [ of Enegren] as the first chamber; the additional chamber in the combination is Appellant[s'] claimed first chamber." Ans. 10. In addition, the presence of additional structures in Enegren does not undermine a rejection where the claim defines the invention using the open- ended term "comprising." See Exergen Corp. v. Wal-Mart Stores, Inc., 575 F.3d 1312, 1319 (Fed. Cir. 2009) ("The claim uses the term 'comprising,' which is well understood in patent law to mean 'including but not limited to."' (quoting CIAS, Inc. v. Alliance Gaming Corp., 504 F.3d 1356, 1360 (Fed. Cir. 2007))). Appellants contend "Enegren's chamber 28 cannot be modified to be ventable using Fischell's approach, as the proposed modification would ... render Enegren unsatisfactory for its intended purpose." Appeal Br. 7. In particular, Appellants contend "the vaporization pressure generated by the two-phase fluid in the interior chamber 28 would be significantly reduced if the chamber 28 were ventable. Consequently, the critical ability for the chamber 28 to expel the infusate from the bellow chamber 26 would be defeated." Appeal Br. 7-8; see also id. at 8-9 ("Because venting gas out of the chamber 28 would prevent [the vapor in Enegren's chamber 28 from condensing into a liquid,] which Enegren's recharging mechanism depends on, one of ordinary skill in the art would not and could not modify Enegren's 6 Appeal 2018-003766 Application 14/317 ,848 chamber 28 to be ventable."); Reply Br. 43 ("[V]enting gas out of [Enegren's] chamber 28 would reduce pressure therein, thereby preventing recharging of the fluid power cell taught by Enegren as well as resulting in (at best) inefficient delivery of the infusate from ... infusate chamber 26 to the patient's body."). Appellants' argmnent is unpersuasive because it fails to point to evidence or provide sound technical reasoning to establish that a skilled artisan would recognize the identified possible disadvantage would outweigh the benefit identified by the Examiner, such that the proposed modification would not have been obvious. Even if the Examiner's proposed modification would not permit Enegren' s design to operate in the same manner or as well, "[a] known or obvious [product] does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). "The fact that the motivating benefit comes at the expense of another benefit ... should not nullify its use as a basis to modify the disclosure of one reference with the teachings of another. Instead, the benefits, both lost and gained, should be weighed against one another." Winner Int'! Royalty Corp. v. Wang, 202 F.3d 1340, 1349 n.8 (Fed. Cir. 2000). Although tradeoffs rnay be required in balancing the benefits and drawbacks of Enegren's chamber 28 being ventable, such tradeoffs do not necessarily prevent the proposed combination or negate the obviousness of the claimed subject matter. See Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006) ("[A] given course of action often has 3 Reply Brief ("Reply Br."), filed Feb. 22, 2018. 7 Appeal 2018-003766 Application 14/317 ,848 simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine."). In this case, the Examiner notes an advantage to modifying Enegren's chamber 28 to be ventable --------namely, to allow a user to adjust the pressure within interior portion/chamber 28 in the event the pressure is too high or too low. See Non-Final Act. 4, 9--10; see also Ans. 8-11. Appellants have not shown that the alleged disadvantage-namely, decreased efficiency in delivery of the infusate from chamber 26 to the patient's body--------0utweighs the advantage identified by the Examiner. Appellants contend the motivation of Enegren is to "maintain the integrity of ... interior portion 28" and this motivation would not be maintained if interior portion 28 were ventable. Reply Br. 4 ( emphasis omitted). However, the Examiner establishes that the "integrity" of interior portion 28 of Enegren would be maintained if interior portion 28 were ventable. In particular, the Examiner states "[ o ]ther than being accessible via the needle (which may perform a venting function), the space [of interior portion/chamber 28] remains a closed space (fluid may not enter or exit)." Ans. 10. We disagree with Appellants that the Examiner fails "to provide any realistic reason or motivation for the proposed modification of Enegren by Fischell." Reply Br. 7. To the contrary, the Examiner provides a reason with rational underpinnings for combining the teachings of Enegren and Fischell, namely, to allow a user to adjust the pressure within interior portion/chamber 28 of Enegren in the event the pressure within the interior portion/chamber is too high or too low. See Non-Final Act. 4, 9--10; see also 8 Appeal 2018-003766 Application 14/317 ,848 Ans. 8-11. Appellants do not provide persuasive evidence or argument apprising us of error. Appellants contend the Examiner "does not articulate any reasons why one of skill in the art would even want to adjust the delivery rate of the infusate." Reply Br. 8; see also id. at 7-8 ("In his Answer, the Examiner argues that by making Enegren's interior portion 28 ventable as taught by Fischell, the delivery rate of the infusate to the patient's body can be adjusted."). However, in the portion of the Answer identified by Appellants, (i.e., page 10 of the Answer (see Reply Br. 8, n.13)), the Examiner refers to adjustment of the delivery rate of fluid via venting or filling interior portion/chamber 28 of Enegren not to adjustment of the delivery rate of the infusate to the infusion site, as proposed by Appellants. See Ans. 1 O; see also Reply Br. 7-8. Thus, Appellants do not apprise us of error. We also are not persuaded the Examiner engages in impermissible hindsight in combining the teachings of Enegren and Fischell. See Reply Br. 8. The Examiner cites specific teachings in the references themselves, not Appellants' disclosure, in support of the Examiner's articulated reasoning for combining the references as proposed in the rejection. See Non-Final Act. 2--4; In re Cree, Inc., 818 F.3d 694, 702 n.3 (Fed. Cir. 2016) (viewing an argument regarding "impermissible hindsight" as "essentially a repackaging of the argument that there was insufficient evidence of a motivation to combine the references" and holding that this argument was addressed by showing that a proper motivation to combine the references in fact existed). Appellants contend "the Examiner equates Enegren's interior chamber 28 with the gas-driven forcing mechanism and the ventable interior portion. 9 Appeal 2018-003766 Application 14/317 ,848 Thus, the Examiner has cited the same element in the prior art (i.e., the interior chamber 28) for two distinct claim elements (i.e., the gas-driven forcing mechanism and the ventable interior portion)." Appeal Br. 9 (footnote omitted). However, in the Answer, the Examiner clarifies element 28 of Enegren is cited "as the interior chamber, but ... Col.4 11 40-42 [ of Enegren is cited] for the gas-driven forcing mechanism, said citation is drawn to the two-phase fluid which, while located within interior chamber 28, is not the same structure as interior chamber 28." Ans. 11. In the Reply Brief, Appellants argue for the first time that Enegren and Fischell are not analogous art. Reply Br. 5-7. Normally, we do not consider new arguments presented in a Reply Brief that are not accompanied by a showing of good cause why they could not have been presented in the Appeal Brief. 37 C.F.R. Â§ 41.41(b)(2); Ex Parte Borden, 93 USPQ2d 1473, 1476-77 (BPAI 2010) (informative). Nonetheless, we address the analogous art argument below. Appellants contend (1) Enegren and Fischell are "in different fields of endeavor"; and (2) "Enegren and Fischell pertain to completely different problems and different solutions." Reply Br. 5-7. However, Appellants are comparing the relevance of Enegren and Fischell to each other, which is not the required legal test and is not persuasive of error. The established precedent of our reviewing Court sets up a two-fold test for determining whether art is analogous: "(1) whether the art is from the same field of endeavor, regardless of the problem addressed and, (2) if the reference is not within the field of the inventor's endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved." In re Klein, 647 F.3d 1343, 1348 (Fed. Cir. 2011) 10 Appeal 2018-003766 Application 14/317 ,848 (quoting In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004)). The "field of endeavor" prong asks if the structure and function of the prior art is such that it would be considered by a person of ordinary skill in the art because of the similarity to the structure and function of the claimed invention as disclosed in the application. Bigio, 381 F.3d at 1325-27. In this case, the subject invention is directed to "an implantable device for administering a liquid." Spec. ,r 7. Similarly, Enegren discloses an implantable apparatus that "enables one to introduce [fluids] into or withdraw [fluids] from the apparatus, after it is implanted" (Enegren, Abstract), and Fischell discloses an implantable apparatus that "can be filled with fluid, or the fluid pressure can be reset, after implantation without necessitating a surgical procedure" (Fischell, Abstract). As both Enegren and Fischell are directed to implantable medical devices for administering a liquid, they are within the field of Appellants' endeavor and are analogous art. In summary, and based on the record presented, we are not persuaded the Examiner erred in rejecting independent claim 1 as unpatentable over Enegren and Fischell. Accordingly, we sustain the Examiner's rejection of claim 1. We further sustain the rejection of claims 5-8, 14, and 15, which fall with claim 1. Obviousness over Enegren, Fischel!, and any of Gibson, Giebmeyer, McEntee, Nelson, or Idriss Claims 2-4 and 9-13 Appellants do not present arguments for claims 2--4 and 9-13 separate from those presented for claim 1. See Appeal Br. 5-10. As we find no 11 Appeal 2018-003766 Application 14/317 ,848 deficiencies in the Examiner's rejection of independent claim 1 as unpatentable over Enegren and Fischell for the reasons discussed above, we likewise sustain the Examiner's obviousness rejections of claims 2--4 and 9-- 13. DECISION We AFFIRM the decision of the Examiner to reject claims 1-15 under 35 U.S.C. Â§ 103. No time period for taking any subsequent action in connection with this appeal may be extended under 3 7 C.F .R. Â§ 1.13 6( a )(1 )(iv). AFFIRMED 12