Ex Parte Hossainy et alDownload PDFPatent Trial and Appeal BoardJul 27, 201613572507 (P.T.A.B. Jul. 27, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/572,507 08/10/2012 45159 7590 07/29/2016 SQUIRE PB (Abbott) 275 BATTERY STREET, SUITE 2600 SAN FRANCISCO, CA 94111-3356 FIRST NAMED INVENTOR Syed Hossainy 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. 085847.00181 6755 EXAMINER BASQUILL, SEAN M ART UNIT PAPER NUMBER 1613 NOTIFICATION DATE DELIVERY MODE 07/29/2016 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): sfripdocket@squirepb.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte SYED HOSSAINY, DARIUSH DAV ALIAN, MIKAEL TROLLSAS, JOHN STANKUS, YUET MEI KHONG, and JINPING WAN 1 Appeal2014-007781 Application 13/572,507 Technology Center 1600 Before JEFFREY N. FREDMAN, RICHARD J. SMITH, and TA WEN CHANG Administrative Patent Judges. SMITH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method of treating vulnerable plaque. 2 A hearing was held on July 8, 2016. We have jurisdiction under 35 U.S.C. § 6(b ). We reverse. 1 According to Appellants, the real party in interest is Abbott Cardiovascular Systems Inc. (Appeal Br. 3.) 2 The Specification states that '"[a]therosclerotic plaque' or 'vulnerable plaque' refers to an atheromatous plaque that has the potential of causing a thrombotic event." (Spec. 5, 11. 23-24.) Appeal2014-007781 Application 13/572,507 STATEMENT OF THE CASE Background "This invention relates to local or regional delivery of a photodynamic therapy3 drug for the treatment of vascular diseases." (Spec. 1, 11. 13-14.) Claims on Appeal Claims 1, 2, 5-7, and 11-17 are on appeal. 4 (Claims Appendix, Appeal Br. 9-10.) Claim 1, the only independent claim, is illustrative and reads as follows: 1. A method of treating vulnerable plaque in a patient in need thereof, compnsmg: administering to the site of a vulnerable plaque, having a fibrous cap and an interior core, a first plurality of nanoparticles comprising a first PDT drug having an excitation wavelength in the blue-green region of the electromagnetic spectrum wherein the first plurality of nanoparticles either affix to the surface of the fibrous cap or penetrate only into the fibrous cap; concurrently administering to the site of the vulnerable plaque a second plurality of nanoparticles comprising a second PDT drug having an excitation wavelength in the red region of the electromagnetic spectrum wherein the nanoparticles are capable of penetrating into the interior of the plaque; exposing the vulnerable plaque site to either blue-green or red light; and, subsequently, exposing the vulnerable plaque site to light of the other excitation wavelength. Examiner's Rejections 1. Claims 1, 2, 11, 13, and 14 stand rejected5 under 35 U.S.C. § 103(a) 3 Photodynamic therapy is abbreviated PDT. (Spec. 1, 1. 16.) 4 Claims 3, 4, and 8-10 are withdrawn as directed to a non-elected invention. Office Action dated Apr. 16, 2013. 5 Claim 12 is dependent on claim 11, but is not expressly mentioned in the Examiner's rejection. (See Appeal Br. 10.) 2 Appeal2014-007781 Application 13/572,507 as unpatentable over Spikes, 6 Robinson, 7 Roby, 8 and Weissleder. 9 (Ans. 2.) 2. Claims 15-17 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Spikes, Robinson, Roby, Gierskcky, 10 Weissleder, Heavner, 11 and Kasina. 12 (Id. at 6.) 3. Claims 5-7 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Spikes, Robinson, Roby, Gierskcky, Weissleder, and Guzman. 13 (Id. at 8.) Issue Whether the preponderance of evidence of record supports the Examiner's conclusion of obviousness under 35 U.S.C. § 103(a). Analysis The issue in this case turns on the teachings of Spikes and Robinson. The Examiner finds that Spikes discloses "blue-green wavelengths and corresponding photosensitizers" and "red-wavelength therapeutics" but "does not specifically recite combining two PDT sensitizer agents in lipospheres for the local delivery and treatment of a plaque." (Ans. 3.) The 6 Spikes et al., Photodynamic Therapy of Tumours and Other Diseases Using Porphyrins, Lasers in Medical Science 2:3, 3-15 (1987) ("Spikes"). 7 Robinson et al., US 6,054,449 issued Apr. 25, 2000 ("Robinson"). 8 Roby et al., Solubilization of Poorly Soluble PDT Agent, Mesotetraphenylporphin, in Plain or Immunotargeted PEG-PE Micelles Results in Dramatically Improved Cancer Cell Killing in Vitro, 62 EUR. J. PHARM. BIOPHARM. 3, 235--40 (2006). 9 Weissleder et al., WO 2007/109364 A2, published Sept. 27, 2007. 10 Gierskcky et al., US 2005/0031541 Al, published Feb. 10, 2005. 11 Heavner et al., US 2007/0092558 Al, published Apr. 26, 2007. 12 Kasina et al., US 6,171,577 Bl, issued Jan. 9, 2001. 13 Guzman et al., Local Intraluminal Infusion of Biodegradable Polymeric Nanoparticles. A Novel Approach for Prolonged Drug Delivery After Balloon Angioplasty, 94 Circulation 6, 1441--48 (1996). 3 Appeal2014-007781 Application 13/572,507 Examiner also finds that Robinson discloses "therapeutic agents which contain multiple PDT sensitizing agents with differing absorption wavelengths." (Id.) Appellants argue that Spikes "does not purport to propose the use of photosensitizers which can be activated by blue or green light for the treatment of atheromatous plaques" and "does not teach or suggest the use of a combination of red and green wavelengths of excitation light for use in the same PDT therapy." (Appeal Br. 5, 7-8.) Appellants also argue that: Robinson discloses compositions comprising a conjugate of a furocoumarin (F) with a reactive oxygen producing photosensitizer (ROPP) to form a furocoumarin- photosensitizer conjugate (F-ROPP). [] The conjugates are used in a method comprising systemic administration of the F-ROPP followed by use of short wavelength light to affix the F-ROPP to a target tissue. A second, longer, wavelength of light is used to perform PDT at the target tissue with the ROPP portion of the F-ROPP acting as the PDT agent. [] Robinson, therefore, is more accurately characterized as disclosing use of a single PDT excitation wavelength with a single PDT drug. (Appeal Br. 8.) The Examiner responds to Appellants' argument regarding the Robinson reference as follows: Appellants' discussion of the Ro bins on reference again focus [es] improperly solely on what the four comers of the Robinson disclosure explicitly contain, and ignore the clear precedent which permits us to conclude that combinations of prior art elements known to be useful for the same purpose, here, providing PDT therapy to a desired location using an agent known by the art to be useful for precisely this utility, are in the absence of secondary indicia of nonobviousness, an obvious permutation of the prior art. (Ans. 12.) 4 Appeal2014-007781 Application 13/572,507 We find that Appellants have the better position. The claims require "concurrently administering" first and second PDT drugs that have an excitation wavelength in the "blue-green region" and "red region," respectively. (Appeal Br. 9.) Lacking on the record before us is a teaching or suggestion of the "concurrently administering" step as claimed by Appellants. Moreover, on this record, we are not persuaded by the Examiner's apparent conclusion that the use of one PDT drug at a desired location renders obvious the concurrent use at that location of two different PDT drugs as claimed; namely, "a first PDT drug having an excitation wavelength in the blue-green region" and "a second PDT drug having an excitation wavelength in the red region" where the two drugs penetrate to specific locations as required by claim 1. See KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) ("[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements"). While the combination of two known components may often be obvious (see, e.g. In re Kerkhoven, 626 F .2d 846, 850 CCP A 1980), there is no articulated reason why the ordinary artisan would have found it obvious to combine the two different PDT drugs targeted to different locations that does not rely upon the Specification as a guide. The obviousness rejection must be based on "some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness." KSR, 550 U.S. at 418 (quoting In re Kahn, 441F.3d977, 988 (Fed. Cir. 2006)). Conclusion of Law A preponderance of the evidence of record fails to support the Examiner's conclusion of obviousness under 35 U.S.C. § 103(a). 5 Appeal2014-007781 Application 13/572,507 SUMMARY We reverse all rejections on appeal. REVERSED 6 Copy with citationCopy as parenthetical citation