Ex Parte Makower et al

Patent Trials and Appeals BoardJan 10, 2019

13578555 - (D) (P.T.A.B. Jan. 10, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/578,555 10/15/2012 142169 7590 01/14/2019 Apertomed LLC 2570 W. El Camino Real Suite 310 Mountain View, CA 94040 FIRST NAMED INVENTOR Joshua Makower 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. NCEPT.002A 1056 EXAMINER IGBOKO, CHIMA U ART UNIT PAPER NUMBER 3771 NOTIFICATION DATE DELIVERY MODE 01/14/2019 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): jhanley@exploramed.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOSHUA MAKOWER, EARL A. BRIGHT II, THEODORE M. BENDER, JOSEPH CANTANESE III, JOHNY. CHANG, THOMAS KING, CLINTON SLONE, THEODORE C. LAMSON, and AZIZ IMRAAN 1 Appeal2018-000568 Application 13/578,555 Technology Center 3700 Before JAMES P. CAL VE, MICHELLE R. OSINSKI, and BRENT M. DOUGAL, Administrative Patent Judges. CAL VE, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant appeals under 35 U.S.C. Â§ 134(a) from the Office Action rejecting claims 1, 2, 4, and 63---68. Appeal Br. 3. Claims 3 and 5---62 are cancelled. Id. at 10 (Claims App.). We have jurisdiction under 35 U.S.C. Â§ 6(b). We AFFIRM. 1 Apertomed, Inc. is identified as the real party in interest. Appeal Br. 2. Appeal2018-000568 Application 13/578,555 CLAIMED SUBJECT MATTER The claimed method is "for treating venous obstruction or venous insufficiency" which also provides treatment for neurological disorders that are associated with such venous obstructions and insufficiencies including multiple sclerosis. Spec. ,r 2. Claim 1, the sole independent claim, is reproduced below. 1. A method for treating chronic cerebrospinal venous insufficiency in a human or mammalian subject, said method comprising the steps of relieving a stenosis at a site in a vein which drains blood from the brain in a subject exhibiting chronic cerebrospinal venous insufficiency, and placing an endovascular device in or near the stenotic body lumen, wherein the device includes a valve. Appeal Br. 10 (Claims App.). REJECTIONS Claim 1 is rejected under 35 U.S.C. Â§ I02(b) as being anticipated by Paul, Jr. (US 2009/0264991 Al, pub. Oct. 22, 2009) ("Paul") or, in the alternative, under 35 U.S.C. Â§ I03(a) as being unpatentable over Paul and Zamboni (A prospective open-label study of endovascular treatment of chronic cerebrospinal venous insufficiency, Journal of Vascular Surgery, Vol. 50, No. 6, 1348-1358, Dec. 2009). Claims 2, 4, and 63----67 are rejected under 35 U.S.C. Â§ 103(a) as being unpatentable over Paul and Zamboni. Claim 68 is rejected under 35 U.S.C. Â§ I03(a) as being unpatentable over Paul, Zamboni, and Case (US 2007/0100432 Al, pub. May 3, 2007). 2 Appeal2018-000568 Application 13/578,555 ANALYSIS Claim 1 Anticipated By Paul, or Unpatentable over Paul and Zamboni The Examiner correctly finds that Paul teaches a method for treating chronic cerebrospinal insufficiency in humans by placing an endovascular device (valved stent) in or near the stenotic body lumen. Non-Final Act. 3. The Examiner also correctly finds that Paul teaches to place a valved device at stenotic body lumen throughout the human body including human jugular veins and placement in the jugular vein would treat chronic cerebrospinal venous insufficiency by allowing blood to drain from the brain. Id. at 3--4. The Examiner correctly finds that Zamboni teaches steps of relieving stenosis at a site in a vein to allow blood to drain from the brain in a subject exhibiting chronic cerebrospinal venous insufficiency (CCVI). Id. at 3. The Examiner correctly reasons that it would have been obvious to combine these teachings to first relieve stenosis at a site in a vein that drains blood from the brain of a patient with CCVI, as taught by Zamboni, before placing a valved endovascular device at the remediated site, as taught by Paul, for the predictable result of relieving CCVI thereby. Id. at 3--4. Appellant acknowledges that Paul teaches to place an endovascular device in a jugular vein. Appeal Br. 7. Paul teaches the use of devices to "maintain the patency of the vessel." Paul ,r,r 3, 7, 8. Indeed, Paul describes such devices as being rigid enough and having sufficient radial strength to maintain vein patency and prevent collapse or fracture. Id. ,r,r 7-9, 30, 33. A skilled artisan would understand from these teachings that Paul's implantable, valved endovascular devices are placed in or near a stenosis to treat venous insufficiency by providing and maintaining venous patency. 3 Appeal2018-000568 Application 13/578,555 Appellant defines "stenosis" as any full or partial blockage or restriction of flow through a body lumen, including but not limited to full or partial blockages or restrictions of flow caused by narrowing of the body lumen, such as being twisted or having sharp reductions in diameter due to malformation, or by the presence of obstructive matter within the body lumen. Spec. ,r 15. Because Paul uses implantable, valved devices to treat venous valve insufficiency, Paul also uses the devices to maintain vein patency and prevent "restenosis." Paul ,r,r 7, 70. An ordinary meaning of "patency" is "[t]he state or quality of being open, expanded, or unblocked." Definition of patency by The American HeritageÂ® Medical Dictionary at https://medical- dictionary.thefreedictionary.com/patency (viewed Jan. 4, 2019). Appellant also acknowledges that Zamboni teaches to restore outflow venous patency from the brain as a way to treat multiple sclerosis. Appeal Br. 7. Nonetheless, Appellant contends that a skilled artisan would not have been motivated to implant Paul's valve in the outflow tract of the brain to treat CCVI because such valves used to treat venous insufficiency generally would not be understood to play a beneficial role in more complex downhill venous flow from the brain. Id. at 7-8. These arguments are not persuasive. First, as discussed above, Paul teaches to implant valved devices in or near stenotic sites to maintain venous patency, and the sites include jugular veins, which drain blood from the brain. See Paul ,r 74. Second, Zamboni teaches not only the use of transluminal angioplasty to relieve stenosis in jugular veins and azygous veins to treat patients with symptoms of multiple sclerosis, but Zamboni also teaches and suggests the use of stents to maintain venous patency. Zamboni, 1348-50, 1353, Fig. 3B. 4 Appeal2018-000568 Application 13/578,555 Zamboni uses a metallic, self-expanding stent to treat venous twisting that cannot be resolved by percutaneous transluminal angioplasty (PTA). Id. at 1353, 1356. Zamboni also teaches that restenosis occurs in patients after PT A of the jugular veins has been undertaken and suggests stent insertion as the "logical alternative" to treat this venous stenosis/restenosis. Id. at 1356. Although Zamboni notes an apparent lack of devices on the market for this purpose, Paul provides the relevant teaching of valved, implantable stents used to maintain venous valve patency and prevent restenosis in veins to include the jugular vein. Id.; Paul ,r,r 3-10, 74. Paul also teaches the use of such devices to treat venous insufficiency diseases that impact a person's ability to work and live a normal lifestyle. Paul ,r 5. Paul's devices include self-expanding and balloon-expandable support frames. Id. ,r,r 64---67. Thus, similar to Zamboni' s use of PT A to relieve steno sis, Paul uses balloons to implant and expand stents to relieve stenosis and maintain patency. These express teachings of Paul and Zamboni provide the rational underpinnings and expectation of success for the Examiner's obviousness determination. Further, contrary to Appellants' assertions of teaching away (Appeal Br. 6), Zamboni teaches to relieve stenosis via PTA and use stents to maintain patency and prevent restenosis. Though Zamboni notes an apparent lack of devices on the market, he also states that their use would be a "logical alternative." Zamboni, 1356. Paul teaches to use implantable, valved devices for CCVI to maintain venous patency and prevent restenosis. Indeed, Appellant acknowledges prior art teachings that stenting is the safest way to avoid restenosis following angioplasty to treat CCVI. See Spec. ,r 10. Thus, there is a reasonable expectation of success. Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). 5 Appeal2018-000568 Application 13/578,555 Appellant discloses the field of their invention as methods, systems, and devices for treating venous obstruction or venous insufficiency and for the treatment of disorders associated therewith. Spec. ,r 2. Paul is directed to treating venous valve insufficiency and venous insufficiency generally to include maintaining venous patency and preventing restenosis. Paul ,r,r 3-9. Similarly, Zamboni treats stenosis of the principal cerebrospinal pathways by eliminating venous strictures of the jugular and azygous veins to improve venous drainage. Zamboni, 1348; Appeal Br. 8 (arguing that the teachings of Paul and Zamboni are not in the same field of endeavor). The teachings of Paul and Zamboni also are reasonably pertinent to the problem Appellant confronted of treating venous insufficiency and stenosis. Accordingly, we sustain the rejection of claim 1 as unpatentable over Paul and Zamboni. 2 Claims 2, 4, and 63-68 Unpatentable over Paul and Zamboni and Case Appellants argue the patentability of claims 2, 4, and 63---68 because they depend from claim 1. Appeal Br. 1. Because we sustain the rejection of claim 1, this argument is not persuasive, and we also sustain the rejections of these claims. DECISION We affirm the rejections of claims 1, 2, 4, and 63-68 under 35 U.S.C. Â§ 103(a). 2 In view of our determination, we do not address the Examiner's alternative determination that Paul anticipates claim 1. 6 Appeal2018-000568 Application 13/578,555 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a)(l )(iv). AFFIRMED 7