Ex Parte Gerrans et alDownload PDFPatent Trial and Appeal BoardOct 11, 201714033181 (P.T.A.B. Oct. 11, 2017) Copy Citation United States Patent and Trademark Office 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 APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 14/033,181 09/20/2013 Lawrence J. Gerrans 04530-P0002H 5664 24126 7590 10/13/2017 ST. ONGE STEWARD JOHNSTON & REENS, LLC 986 BEDFORD STREET STAMFORD, CT 06905-5619 EXAMINER FLICK, JASON E ART UNIT PAPER NUMBER 3763 NOTIFICATION DATE DELIVERY MODE 10/13/2017 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): patentpto@ ssjr.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte LAWRENCE J. GERRANS and ERHAN H. GUNDAY Appeal 2016-001996 Application 14/033,181 Technology Center 3700 Before MICHAEL L. HOELTER, JEFFREY A. STEPHENS, and ERIC C. JESCHKE, Administrative Patent Judges. JESCHKE, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Lawrence J. Gerrans and Erhan H. Gunday (“Appellants”)1 seek review under 35 U.S.C. § 134(a) of the Examiner’s decision, as set forth in the Final Office Action dated December 15, 2014 (“Final Act.”), and as further explained in the Advisory Action dated March 6, 2015, rejecting claims 1—4 and 6—35. The Examiner objects to claim 5 but indicates that it would be allowable if rewritten in independent form. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellants identify Sanovas, Inc. as the real party in interest. Appeal Br. 2. Appeal 2016-001996 Application 14/033,181 BACKGROUND The disclosed subject matter “relates to methods and systems for delivering therapeutic and diagnostic agents to specific cellular locations within and adjacent to bodily tissues and cavities.” Spec. 11. Claims 1 and 10 are independent. Claim 1 is reproduced below, with emphasis added and with bracketed letters added to identify each clause: 1. A method of extravasated delivery of a therapeutic and/or diagnostic agent to tissue, comprising the steps of: [a] inserting a catheter into a bodily cavity, said catheter comprising a first balloon; a second balloon; and a third balloon positioned between the first and second balloons and having a wall with an abrasive outer surface; [b] inflating the first and second balloons to create a chamber between the first balloon and the second balloon, wherein the boundaries of the chamber are defined by an inner surface of the cavity wall and the catheter; [c] stimulating a flow of blood cells by repeatedly inflating and deflating the third balloon by supplying fluid to the third balloon such that the abrasive outer surface abrades tissue in the bodily cavity as the third balloon is repeatedly inflated and deflated; and [d] delivering the therapeutic and/or diagnostic agent to the chamber and external of the third balloon after stimulating the flow of blood cells. 2 Appeal 2016-001996 Application 14/033,181 EVIDENCE RELIED ON BY THE EXAMINER Rishton US 3,720,199 Mar. 13, 1973 Wolinsky US 4,824,436 Apr. 25, 1989 Hart US 5,868,708 Feb. 9, 1999 Rosenthal US 2003/0114791 Al June 19, 2003 Kramer US 2006/0135984 Al June 22, 2006 Lary US 2006/0189930 Al Aug. 24, 2006 Smithrud US 2007/0027075 Al Feb. 1,2007 Zadno-Azizi US 2007/0060942 A2 Mar. 15,2007 Goldman US 2008/0208118 Al Aug. 28, 2008 LePivert US 2008/0300571 Al Dec. 4, 2008 Wellman US 7,611,484 B2 Nov. 3, 2009 Petricoin, III US 2010/0074895 Al Mar. 25, 2010 Golzarian US 2011/0082427 Al Apr. 7,2011 Sih US 8,052,668 B2 Nov. 8,2011 Bastid US 2011/0293629 Al Dec. 1,2011 Meric A. Altinoz et al., Noscapine and Diltiazem Augment Taxol and Radiation-Induced S-Phase Arrest and Clonogenic Death of C6 Glioma In Vitro, 65 Surgical Neurology 478-485 (2006) (hereinafter “Altinoz”). REJECTIONS 1. Claims 1, 2, 7, 10, 11, 14, 15, and 20 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Lary and Rosenthal. 2. Claims 3, 4, 21, and 22 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Lary, Rosenthal, and Hart. 3. Claims 6, 12, 16, and 17 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Lary, Rosenthal, and Rishton. 4. Claims 8 and 13 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Lary, Rosenthal, and Zadno-Azizi. 5. Claims 18, 33, and 34 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Lary, Rosenthal, and Goldman. 3 Appeal 2016-001996 Application 14/033,181 6. Claim 9 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Lary, Rosenthal, and Sih. 7. Claim 19 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Lary, Rosenthal, and Wellman. 8. Claims 23, 31, and 32 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Lary, Rosenthal, and Golzarian. 9. Claim 24 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Lary, Rosenthal, and LePivert. 10. Claim 25 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Lary, Rosenthal, and Smithrud. 11. Claim 26 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Lary, Rosenthal, and Kramer. 12. Claim 27 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Lary, Rosenthal, and Altinoz. 13. Claims 28 and 30 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Lary, Rosenthal, and Bastid. 14. Claim 29 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Lary, Rosenthal, and Petricoin, III. 15. Claim 35 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Lary, Rosenthal, and Wolinsky. DISCUSSION Appellants argue the patentability of the two independent claims in Rejection 1 as a group and do not separately argue any dependent claims. Appeal Br. 6—12. We select independent claim 1 as representative, with the remaining claims in Rejection 1 standing or falling with claim 1. See 37 4 Appeal 2016-001996 Application 14/033,181 C.F.R. § 41.37(c)(l)(iv) (2014). Appellants do not present any additional arguments for the patentability of dependent claims 3, 4, 6, 8, 9, 12, 13, 16— 19, and 21—35, at issue in Rejections 2 through 15. Appeal Br. 12. Accordingly, the outcome of this appeal turns on our analysis of the rejection of independent claim 1. For claim 1, the Examiner relied on Lary for certain limitations (Final Act. 3—4), but stated that “Lary does not specifically disclose the process of inflating and deflating the third balloon is repeated” {id. at 4). See also Appeal Br. 14 (Claims App.) (clause c). The Examiner found, however, that Rosenthal teaches “an apparatus and method which utilizes a balloon catheter for drug delivery to tissue at a desired location” and “further discloses that the balloon (figures 7, 7a, and 7b; item 15) may be repeatedly inflated and deflated in order to deliver a drug (figure[s] 7a and 7b, item 16) to a specific tissue location.” Final Act. 4 (citing Rosenthal Tflf 46, 67). According to the Examiner, it would have been obvious for one of ordinary skill in the art at the time of the invention to modify the method taught by Lary, with the method step of repeatedly increasing and decreasing the fluid pressure within the chamber by at least partially inflating and at least partially deflating the third balloon, as taught by Rosenthal, in order to provide increased efficiency and effectiveness of drug delivery by allowing for a means to ensure proper and sufficient drug saturation within treated tissue before and after a treatment procedure. Id. First, Appellants state that claim 1 is “not [an] apparatus claim[] reciting structure that performs a particular function, which may be anticipated by prior art that simply discloses the claimed structure if it is capable of performing the recited function,” but rather, is a “method claim[], 5 Appeal 2016-001996 Application 14/033,181 which recite[s] specific method steps.” Appeal Br. 6. Appellants then recite clauses c and d in claim 1 (emphasizing the language in italics above), and argue that “while the Office Action identifies various disclosures concerning inflation/deflation, drug delivery, and abrasion, it does not address these specific steps.” Id. at 6—7. To the extent Appellants contend that the Examiner has failed to establish a prima facie case of obviousness as to clauses c and d, we disagree. Below, we provide our understanding of the modified process of Lary and Rosenthal relied on by the Examiner. As to clause a, we understand the Examiner to rely on the process shown in Figure 7 of Lary, as modified by the presence of abrasive surface 231 shown in Figure 8 of Lary (to address the “abrasive outer surface” limitation). See Final Act. 3 (paragraph beginning “inserting a catheter”), 4 (“Lary discloses the third balloon (figures 7 and 8, item 128/228) has a wall with an abrasive outer surface (figure 8, item 231).”). As to clause b, we understand the Examiner to rely on the process described in, for example, paragraphs 55 and 56 of Lary, which discuss Figure 7. See Final Act. 3. As to clause c, we understand the Examiner to rely on the process of Lary, as modified by certain teachings of Rosenthal. Specifically, in the modified process, the relied-upon structures of Lary (as discussed regarding clauses a and b) would be operated by repeatedly inflating and deflating (as taught by Rosenthal Tflf 46, 67) the identified “third balloon” 128/228 (in Lary, Figures 7 and 8, respectively). See Final Act. 4 (“It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method taught by Lary, with the method step of repeatedly increasing and decreasing the fluid pressure within the chamber by at least 6 Appeal 2016-001996 Application 14/033,181 partially inflating and at least partially deflating the third balloon, as taught by Rosenthal. . . We understand the Examiner to take the position that, while repeatedly inflating and deflating the identified “third balloon,” the identified “abrasive outer surface” (element 231 of Lary) would—based on its location on the “third balloon”—“abrade[] tissue in the bodily cavity” and thereby “stimulate^ a flow of blood cells” as recited in clause c. See Final Act. 4; Ans. 16—17 (“It is clear that the repeated inflating and deflating of the balloon is not what would stimulate the flow of blood cells, but the abrasive outer surface of the balloon which actually abrades the tissue.”). As to clause d, we understand the modified process to deliver agent with each inflation step for each cycle of inflating and deflating. See Ans. 17 (“[T]he [EJxaminer has relied upon the prior art to Rosenthal to teach the method step of repeatedly inflating and deflating a balloon in order to facilitate the delivery of a drug”); see also Final Act. 4 (“Rosenthal further discloses that the balloon (figures 7, 7a, and 7b; item 15) may be repeatedly inflated and deflated in order to deliver a drug (figure[s] 7a and 7b, item 16) to a specific tissue location.”); Final Act. 4 (concluding that one of ordinary skill in the art would have modified Fary with Rosenthal “in order to provide increased efficiency and effectiveness of drug delivery by allowing for a means to ensure proper and sufficient drug saturation within treated tissue before and after a treatment procedure” (emphasis added)). For the “stimulating the flow of blood cells” limitation in clause d, we understand the Examiner to rely on a certain inflation step (for example, at a time t), which would include (1) abrasion of tissue and thus stimulation of a flow of blood cells (relied upon to address clause c) and (2) delivery of an agent (not relied upon to address clause d). For the “delivering the therapeutic and/or 7 Appeal 2016-001996 Application 14/033,181 diagnostic agent. . . after stimulating the flow of blood cells” in clause d, we understand the Examiner to rely on a later inflation step (for example, at time t which would again include (1) abrasion of tissue and thus stimulation of a flow of blood cells (not relied upon to address clause c) and (2) delivery of an agent (relied upon to address clause d). See Ans. 17 (“In this light, the limitation of ‘repeatedly inflating and deflating’ could be met simply by two inflation/deflation cycles.”). For these reasons, we determine that the Examiner provided sufficient explanation so that Appellants were “properly notified and able to respond.” Hyatt v. Dudas, 492 F.3d 1365, 1370 (Fed. Cir. 2007), quoted in In re Jung, 637 F.3d 1356, 1362 (Fed. Cir. 2011). Further, we do not understand the Examiner to have rejected claim 1 based on a determination that the relied- upon structures are merely capable of performing the recited steps. Second, Appellants identify certain statements in the Office Action, and argue that the Examiner is “essentially omitting parts of’ clause c because “[ujnless the balloon is inflated and deflated, the abrasive outer surface would not come into contact with the tissue and abrade it thereby stimulating the flow of blood cells.” Appeal Br. 7—8. Appellants argue that the Examiner “appears to be parsing out [clause c] into two separate steps of ‘stimulating a flow of blood cells’ and ‘repeatedly inflating and deflating the third balloon.’” Id. at 10. According to Appellants, “a person of skill in the art would not understand the step of ‘stimulating a flow of blood cells by repeatedly inflating and deflating’ the balloon as being two separate method steps.” Id. at 11. We are not apprised of error by the Examiner based on this argument. Clause c requires three causally linked events: (1) a “third balloon” being 8 Appeal 2016-001996 Application 14/033,181 “repeatedly inflated and deflated” causes (2) an “abrasive outer surface” to “abrade[] tissue,” which causes (3) “stimulating a flow of blood cells.” See Ans. 16 (“With regards to the step of ‘stimulating a flow of blood cells,’ the currently recited claim limitation indicates this is achieved ‘by repeatedly inflating and deflating the third balloon by supplying fluid to the third balloon such that the abrasive outer surface abrades tissue in the bodily cavity . . . Appeal Br. 7—8 (“Unless the balloon is inflated and deflated, the abrasive outer surface would not come into contact with the tissue and abrade it thereby stimulating the flow of blood cells.”). Contrary to Appellants’ argument, however, the Examiner need not identify a single prior art reference that alone discloses all three events in clause c. Cf. Reply Br. 2 (arguing that “the Examiner does not cite any prior art in which the flow of blood cells is stimulated by repeatedly inflating and deflating a balloon”). As discussed above, we understand the Examiner to rely on Lary as modified by Rosenthal, rather than Lary alone, to address clause c. See In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (“Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references.”). As to the statements identified by Appellants,2 we understand the Examiner to be discussing how abrasion of tissue—even if provided by moving a balloon along the tissue surface (see Final Act. 4 (discussing Lary 2 In the statements identified, the Examiner stated (1) that “the repeated inflating and deflating of the balloon is not what would stimulate the flow of blood cells, but the abrasive outer surface of the balloon” (Final Act. 17) and (2) that Lary discloses the “step of abrading tissue (simulating a flow of blood cells)... by contacting the tissue with the abrasive surface when the third balloon is inflated” (id. at 18). 9 Appeal 2016-001996 Application 14/033,181 1 57)) rather than inflating and deflating a balloon—would still necessarily lead to stimulating a flow of blood cells. See Ans. 16—17 (“It is clear that the repeated inflating and deflating of the balloon is not what would stimulate the flow of blood cells, but the abrasive outer surface of the balloon which actually abrades the tissue.”), 17—18 (“[WJherein a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect (i.e.[,] stimulating a flow of blood cells) in haec verba is of no significance as the reference meets the claim under the doctrine of inherency.”). Third, Appellants argue that “[t]he method of delivering a sclerosing agent to a blood vessel disclosed in Lary is very different from the method of extravasated delivery of a therapeutic and/or diagnostic agent to tissue of the present invention.” Appeal Br. 8. Appellants also argue that “Lary does not disclose repeatedly inflating and deflating the balloon to cause the abrasive surface of the balloon to abrade tissue” and “[therefore, [Lary] does not disclose stimulating the flow of blood cells in this wav in order to facilitate extravasation of a drug subsequently delivered to the target site, as is recited in the claims.” Id. at 8—9. Appellants argue that “similarly to Lary, Rosenthal fails to disclose the step of stimulating the flow of blood cells by repeatedly inflating and deflating the balloon to cause the abrasive surface of the balloon to abrade tissue, as recited in the claims.” Id. at 9. Appellants contend that “[t]he balloon i[n] Rosenthal is deflated and expanded again only to refill the balloon and deliver more drug” and that “the balloon of Rosenthal does not have an abrasive outer surface and thus, 10 Appeal 2016-001996 Application 14/033,181 the repeated inflation and deflation of the balloon does not and could not abrade tissue and stimulate the flow of blood cells.” Id. at 9-10. We are not apprised of error based on this argument. Nonobviousness cannot be established by attacking references individually when the rejection is based on a combination of prior art. See Merck, 800 F.2d at 1097. Here, by arguing that neither Lary nor Rosenthal, alone, teaches all aspects of clauses c and d, Appellants do not address the rejection as articulated, in which the Examiner relies on certain combined teachings of the prior art (as discussed above regarding Appellants’ first argument). Fourth, Appellants contend that “Rosenthal specifically teaches away from abrading tissue, by any means, as it can cause restenosis or closing of the vessel.” Appeal Br. 10 (citing Rosenthal 15).3 According to Appellants, “Rosenthal teaches away from abrading tissue and instead teaches a gentle application [of drug] to avoid injury or disruption to the vessel wall.” Id. (citing Rosenthal ^fl[ 44, 46, 65). A reference teaches away “when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). Evidence concerning whether the prior art teaches away from an invention must relate to and be commensurate in scope with the claims at 3 Paragraph 5 of Rosenthal provides, inter alia: “The aftermath of angioplasty in many cases is problematic, due to restenosis, or closing of the vessel, that can occur from causes including mechanical abrasion and the proliferation of smooth muscle cells stimulated by the angioplasty treatment.” 11 Appeal 2016-001996 Application 14/033,181 issue. See MeadWestVaco Corp. v. Rexam Beauty & Closures, Inc., 731 F.3d 1258, 1264—65 (Fed. Cir. 2013); In re Kahn, 441 F.3d 977, 990 (Fed. Cir. 2006); In re Zhang, 654 F. App’x 488, 490 (Fed. Cir. 2016) (nonprecedential) (“While a prior art reference may indicate that a particular combination is undesirable for its own purposes, the reference can nevertheless teach that combination if it remains suitable for the claimed invention^ (emphasis added)). Rosenthal teaches that “mechanical abrasion” during angioplasty can cause “restenosis” and teaches “delivery of drugs to a desired location within the body” instead of performing angioplasty. Rosenthal H 2, 5. Although Rosenthal teaches that “mechanical abrasion” may have disadvantages in certain contexts, it does not address the use of abrasion with the subsequent delivery of drugs, as in claim 1. On the current record, we determine that Rosenthal does not teach away from the claimed invention. Fifth, Appellants argue that neither Lary nor Rosenthal discloses clause d (emphasizing the language in italics above). Appeal Br. 11. Appellants argue that “the device of Lary first delivers the drug to the chamber between the distal and proximal balloons, and then the drug is massaged into tissue by moving the middle balloon back and forth or along the vessel, which may also abrade tissue.” Id. In addition, Appellants argue, “[similarly, in Rosenthal, the drug is first released from the hydrogel layer and then the balloon may be deflated, refilled with more drug and reinflated.” Id. Thus, according to Appellants, “neither reference discloses the step of delivering an agent ‘after stimulating the flow of blood cells.’” Id. at 12. 12 Appeal 2016-001996 Application 14/033,181 We are not apprised of error based on this argument. By arguing that neither Lary nor Rosenthal, alone, teaches all aspects of clause d, Appellants do not address the rejection as articulated, in which the Examiner relies on certain combined teachings of the prior art. See Merck, 800 F.2d at 1097. As discussed above regarding Appellants’ first argument, in the context of the modified process, clause d would be satisfied by a first inflation step “stimulating the flow of blood cells” and a second inflation step “delivering the therapeutic and/or diagnostic agent.” We note that clauses c and d do not preclude additional stimulation of the flow of blood cells during delivery of the therapeutic and/or diagnostic agent and also do not preclude additional delivery of the therapeutic and/or diagnostic agent during stimulation of the flow of blood cells. As to Appellants’ arguments that the Examiner failed to address the “after stimulating the flow of blood cells” limitation in clause d (Appeal Br. 12; Reply Br. 2), for the reasons discussed above regarding Appellants’ first argument, we determine that the Examiner provided sufficient explanation so that Appellants were “properly notified and able to respond.” Hyatt, 492 F.3d at 1370, quoted in In re Jung, 637 F.3d at 1362. For these reasons, we sustain the rejection of independent claim 1 as unpatentable. Claims 2-4 and 6—35 fall with claim 1. DECISION We affirm the decision to reject claims 1—4 and 6—35. 13 Appeal 2016-001996 Application 14/033,181 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1). See 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED 14 Copy with citationCopy as parenthetical citation