Ex Parte Kamrava

Patent Trial and Appeal BoardNov 26, 2012

11388467 (P.T.A.B. Nov. 26, 2012)

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. 11/388,467 03/24/2006 Michael M. Kamrava 5603P001X3 6123 7590 11/26/2012 Michael M. Kamrava P.O. Box 5731 Beverly Hills, CA 90210 EXAMINER NGUYEN, CAMTU TRAN ART UNIT PAPER NUMBER 3772 MAIL DATE DELIVERY MODE 11/26/2012 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte MICHAEL M. KAMRAVA ____________ Appeal 2012-001507 Application 11/388,467 Technology Center 3700 ____________ Before LINDA E. HORNER, SCOTT E. KAMHOLZ, and MITCHELL G. WEATHERLY, Administrative Patent Judges. HORNER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Michael M. Kamrava (Appellant) seeks our review under 35 U.S.C. § 134 of the Examiner’s decision rejecting claims 1-5, 7, 10-12, and 14-46. Claims 6, 8, 9, and 13 are canceled. We have jurisdiction under 35 U.S.C. § 6(b). Appeal 2012-001507 Application 11/388,467 2 We AFFIRM-IN-PART.1 THE INVENTION Appellant’s claimed invention relates to an embryo delivery catheter to deliver an embryo to a uterus of a subject. Claims 1, 14, 32, and 37 are independent. Claim 1, reproduced below, is representative of the subject matter on appeal. 1. An embryo delivery catheter to deliver an embryo to a uterus of a subject comprising: a tubular shaft comprising a tubular body with a proximal portion and a distal portion, the tubular shaft having a length to be inserted through a channel of a hysteroscope, the tubular body defining a lumen from the proximal portion to the distal portion, the distal portion having an exterior dimension suitable for insertion into the uterus of the subject as a procedural instrument in an embryo delivery procedure, the distal portion having a beveled opening, such that a length of the shaft to a first point at the beveled opening is a first length and a length of the shaft to a second point at the beveled opening is a second length longer than the first length, a portion of the tubular body of the shaft extending a length distally from the second point and defining a tip, wherein the tip comprises a material that has sufficient rigidity to penetrate an endometrial lining of the subject and sufficient flexibility to resist penetration of a uterine muscle of the subject, and wherein the tip has a shape that is suitable for insertion into the endometrial lining of the subject as a microsurgical instrument to form a pocket in the endometrial lining that is to receive the embryo through the beveled opening. 1 This appeal is related to Appeal 2010-010201 in related Application 10/080,177 and Appeal 2011-005321 in related Application 10/725,623. Appeal 2012-001507 Application 11/388,467 3 THE EVIDENCE The Examiner relies upon the following evidence: Owings US 2,904,045 Sep. 15, 1959 Saito US 5,575,780 Nov. 19, 1996 Fisher US 6,709,408 B2 Mar. 23, 2004 THE REJECTIONS Appellant seeks review of the following rejections: 1. Claim 12 is rejected under 35 U.S.C. § 101 as being directed to patent-ineligible subject matter. 2. Claims 1, 3-5, 7, 10-12, 14-27, and 29-46 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Fisher and Saito. 3. Claim 2 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Fisher, Saito, and Owings.2 The Final Office Action from which this appeal is taken includes a rejection of claim 28 under 35 U.S.C. § 112, first paragraph, for failing to comply with the written description requirement. Final Office Action, p. 3; see also Ans. 5. Appellant lists claim 28 as a claim on appeal but does not include the rejection of claim 28 under 35 U.S.C. § 112, first paragraph, in the listing of the Grounds of Rejection to be Reviewed on Appeal and does not present arguments against this ground of rejection. App. Br. 4, 10. As 2 Appellant lists claim 2 as a claim on appeal but does not include the separate ground of rejection of claim 2 under 35 U.S.C. § 103(a) in the listing of the Grounds of Rejection to be Reviewed on Appeal. App. Br. 4, 10. We understand Appellant to be seeking review of the rejection of claim 2 based on the arguments presented against the base combination of Fisher and Saito as they apply to independent claim 1, from which claim 2 depends. Appeal 2012-001507 Application 11/388,467 4 such, we summarily sustain the rejection of claim 28 under 35 U.S.C. § 112, first paragraph. ISSUES The issues presented by this appeal are: Is a claim directed to a catheter comprising an embryo in the distal portion directed to patent-ineligible subject matter? Did the Examiner articulate adequate reasoning based on rational underpinnings to explain why one of ordinary skill in the art would have been led, in light of Saito, to modify the beveled opening on Fisher’s aspiration biopsy needle to include a tip extended therefrom? ANALYSIS Rejection under 35 U.S.C. § 101 The Examiner rejected claim 12 because it positively recites non- statutory subject matter, i.e., a human embryo. Ans. 5. Appellant argues that claim 12 does not claim an embryo, but rather claims a catheter having an embryo in the distal portion. App. Br. 20. Appellant further argues that “as claimed, the embryo in the catheter is a non-naturally occurring combination (e.g., outside the human body), which does not occur in nature (i.e., extracted embryos within catheters do not occur in nature), but rather is the product of human ingenuity.” App. Br. 20-21. We disagree with Appellant’s contention that claim 12 does not positively recite an embryo. Claim 12 is directed to the combination of a catheter and an embryo, and thus positively recites an embryo. If Appellant had intended not to encompass an embryo, the claims could have recited that Appeal 2012-001507 Application 11/388,467 5 “the distal portion of the catheter is adapted to receive/hold an embryo.” Appellant chose, however, to positively claim an embryo within the distal portion. Appellant does not challenge the Examiner’s determination that a human embryo is non-statutory subject matter. Rather, Appellant argues that because the non-statutory subject matter is claimed in combination with statutory subject matter, the claims are directed to statutory subject matter. The fact that the claims cover patent-eligible subject matter, i.e., a catheter or device, in combination with patent-ineligible subject matter, a human embryo, does not render the claims patent eligible. To allow one to sidestep 35 U.S.C. § 101 by simply pairing in combination patent-ineligible subject matter with patent-eligible subject matter would impermissibly exalt claim strategy (form) over claimed subject matter (substance).3 As such, we affirm the rejection of claim 12 under 35 U.S.C. § 101 as being directed to patent- ineligible subject matter. Rejections under 35 U.S.C. § 103(a) The Examiner determined that Fisher discloses a hollow needle having a beveled opening, but does not disclose that the second point of the needle shaft is distally extended defining a tip. Ans. 6. The Examiner 3 We note that section 33(a) of the Leahy-Smith America Invents Act (AIA) creates a statutory expression of the Office’s longstanding position that human organisms are not patent-eligible subject matter. AIA, Public Law 112-29, sec. 33(a), 125 Stat. 284 (Sept. 16, 2012) (“Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.”). Appeal 2012-001507 Application 11/388,467 6 determined that Saito discloses a medical needle including a beveled distal portion where a portion of the shaft extends distally from the second point defining a tip. Ans. 6-7. The Examiner concluded that “it would have been obvious to one skilled in the art to modify the Fisher’s beveled opening at the distal end to include a tip extended from the second point, taught by Saito, for purposes of maintaining materials thereon.” Ans. 7. Appellant argues that the Examiner failed to articulate adequate reasoning based on rational underpinning to modify Fisher’s aspiration biopsy needle to include the tip of Saito, because such a modification would place the scraped cellular material farther from the entry of the lumen where the material would be subjected to reduced vacuum levels, and that maintaining materials on the tip is contrary to the objective of Fisher of sucking or drawing the materials into the lumen of the needle. App. Br. 15. Fisher discloses a hollow aspiration biopsy needle having a first sharp edge comprised of a beveled distal end of the needle. Fisher, col. 3, ll. 48- 53. Fisher also discloses a second sharp edge formed on the opening of a slot disposed transversely relative to the longitudinal axis of the needle. Fisher, col. 3, ll. 55-63. These first and second sharp edges enable Fisher’s needle to scrape cellular material during both proximal-to-distal and distal- to-proximal travel of the needle. Fisher, col. 3, ll. 48-63. Fisher discloses that the structure also includes conventional means for applying a vacuum to a proximal end of the needle so that cellular material removed by the first and second sharp edges is pulled into the lumen. Fisher, col. 3, l. 63 – col. 4, Appeal 2012-001507 Application 11/388,467 7 l. 2. Fisher does not discuss a need to maintain materials on a tip of the aspiration biopsy needle. Saito discloses “a medical hollow needle, such as a needle for hypodermic injection, dialysis, intravenous drip and blood collection, and a cannular needle. . . .” Saito, col. 1, ll. 7-9. Saito discloses that the sharp edge of the needle is made “extremely thin” so that “a patient or the like hardly gets hurt in blood vessel at the injection part at the time of execution of injection . . . and he can hardly feel the pain at the injection part.” Saito, col. 2, ll. 16-24. Saito does not disclose forming a thinned portion on the sharp edge of the needle so as to maintain materials on a tip of the needle. The Examiner failed to adequately explain why one of ordinary skill in the art would have found it desirable to modify the needle of Fisher to render it capable of maintaining materials on a tip of the needle, and neither reference describes maintaining materials on the tip of the needle during use. As such, the Examiner’s articulated reasoning is inadequate to explain why one of ordinary skill in the art would have been led to make the proposed modification to result in the claimed invention. “[R]ejections on obviousness grounds cannot be sustained by merely conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (cited with approval in KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)). Accordingly, we reverse the rejection of claims 1, 3-5, 7, 10-12, 14-27, and 29-46 under 35 U.S.C. § 103(a) based on Fisher and Saito. Appeal 2012-001507 Application 11/388,467 8 The Examiner’s rejection of dependent claim 2 under 35 U.S.C. § 103(a) as being unpatentable over Fisher, Saito, and Owings suffers from the same deficiency in that the rejection is based on inadequate reasoning to modify Fisher with the teaching of Saito. Ans. 9. Accordingly, we also reverse the rejection of claim 2 under 35 U.S.C. § 103(a) as being unpatentable over Fisher, Saito, and Owings. CONCLUSIONS The claim directed to a catheter comprising an embryo in the distal portion is directed to patent-ineligible subject matter. The Examiner failed to articulate adequate reasoning based on rational underpinnings to explain why one of ordinary skill in the art would have been led, in light of Saito, to modify the beveled opening on Fisher’s aspiration biopsy needle to include a tip extended therefrom. DECISION We AFFIRM the decision of the Examiner to reject claim 12 under 35 U.S.C. § 101 and claim 28 under 35 U.S.C. § 112, first paragraph. We REVERSE the decision of the Examiner to reject claims 1-5, 7, 10-12, 14- 27, and 29-46 under 35 U.S.C. § 103(a). No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED-IN-PART Appeal 2012-001507 Application 11/388,467 9 mls