Ex Parte Kamrava

Patent Trial and Appeal BoardNov 26, 2012

10725623 (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. 10/725,623 12/01/2003 Michael M. Kamrava 5603P001X2 4992 8791 7590 11/26/2012 BLAKELY SOKOLOFF TAYLOR & ZAFMAN 1279 Oakmead Parkway Sunnyvale, CA 94085-4040 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 2011-005321 Application 10/725,623 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 1-18 and 26-34. Claims 19-25 are canceled. We have jurisdiction under 35 U.S.C. § 6(b). Appeal 2011-005321 Application 10/725,623 2 We AFFIRM-IN-PART.1 THE INVENTION Appellant’s claimed invention relates to a catheter or apparatus for introducing an embryo into a uterus of a subject. Spec., para. [0007]. Claims 1, 11, and 34 are independent. Claim 1, reproduced below, is representative of the subject matter on appeal. 1. A catheter comprising: a shaft comprising a body with a proximal portion and a distal portion, the body having a length configured for placement through an endoscopic device in an assisted embryo transfer procedure and the body defining an opening from the proximal portion to the distal portion, the distal portion having an exterior dimension suitable for insertion into a body of a subject as a procedural instrument for transferring an embryo, the distal portion having an end that is beveled in a first direction across the opening, such that a length of the shaft to a first point on the end is a first length and a length of the shaft to a second point on the end is a second length longer than the first length, a portion of the shaft including the second point is beveled in a second direction opposite the first direction defining a tip shaped to be inserted into an endometrial lining of the subject, and wherein the tip comprises a material that has sufficient rigidity to penetrate the endometrial lining of the subject and sufficient flexibility to resist penetration of a uterine muscle of the subject. THE EVIDENCE The Examiner relies upon the following evidence: Gobby US 4,474,576 Oct. 2, 1984 1 This appeal is related to Appeal 2010-010201 in related Application 10/080,177 and Appeal 2012-001507 in related Application 11/388,467. Appeal 2011-005321 Application 10/725,623 3 Bacich US 5,472,419 Dec. 5, 1995 THE REJECTIONS2 Appellant seeks review of the following rejections: 1. Claims 30 and 33 are rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter. 2. Claims 1-18 and 26-34 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Gobby and Bacich. ISSUES The issues presented by this appeal are: Are claims directed to a catheter/apparatus comprising an embryo in the distal portion directed to patent-ineligble subject matter? Would the combined teachings of Gobby and Bacich have rendered obvious to one of ordinary skill in the art a catheter having a shaft with a tip shaped to be inserted into an endometrial lining of the subject, as claimed?3 Appellant also seeks the Board’s review of the Examiner’s objection to drawings. App. Br. 9-10. This objection is petitionable, not appealable. 2 The Examiner withdrew a rejection of claims 1, 11, 28, and 32 under 35 U.S.C. § 112, first paragraph, for failing to comply with the written description requirement. Ans. 8. 3 Independent claim 1 recites the claim language as presented in the statement of the issue. Independent claim 11 similarly recites an apparatus comprising a shaft with an angled tip having a shape that is suitable for insertion into an endometrial lining of the subject, and independent claim 34 similarly recites an apparatus comprising a microsurgical instrument with an angled tip that is shaped for insertion into an endometrial lining. Appeal 2011-005321 Application 10/725,623 4 See Ex parte Frye, 94 USPQ2d 1072, 1078 (BPAI 2010) (precedential) (for discussion of petitionable matters versus appealable matters). ANALYSIS Rejection under 35 U.S.C. § 101 The Examiner rejected claims 30 and 33 because the claim language “an embryo in the distal portion” “positively claim[s] non-statutory subject matter.” Ans. 4. Appellant argues that claims 30 and 33 do not claim an embryo, but rather claim a catheter having an embryo in the distal portion. App. Br. 10. 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, but rather which is the product of human ingenuity.” Id. We disagree with Appellant’s contention that claims 30 and 33 do not positively recite an embryo. Claims 30 and 33 are directed to the combination of a catheter and an embryo, and thus positively recite an embryo. As noted by the Examiner, if Appellant had intended not to encompass an embryo, the claims could have recited that “the distal portion of the catheter is adapted to receive/hold an embryo.” Ans. 8. 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 Appeal 2011-005321 Application 10/725,623 5 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).4 As such, we affirm the rejection of claims 30 and 33 under 35 U.S.C. § 101 as being directed to patent-ineligible subject matter. Rejection under 35 U.S.C. § 103(a) The Examiner acknowledged that Gobby does not disclose a beveled distal end portion as called for in the claims. Ans. 4. Indeed, Gobby discloses that the apparatus, which is used for artificial insemination, has a rounded end so as not to inflict injury during the artificial insemination operation. Gobby, col. 4, ll. 34-42. The Examiner determined that Bacich discloses a transfer catheter body comprising a distal portion having a beveled end, and that it would have been obvious to modify the Gobby apparatus such that the distal portion would be beveled. Ans. 5-6. The Examiner determined that “Figures 4 & 8 in the Bacich reference illustrate the tip of catheter body (13, 13a) is shaped to be inserted into the endometrial lining of the subject.” Ans. 6. 4 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 2011-005321 Application 10/725,623 6 Bacich discloses an IVF transfer catheter having a blunt distal end 25 “[t]o reduce the likelihood of trauma.” Bacich, col. 2, ll. 26-27; col. 4, l. 54; col. 6, ll. 8-16; figs. 2, 5, 6, and 8. As such, Gobby, as modified to add the beveled end of Bacich as proposed by the Examiner, would not result in a catheter having a tip that is shaped to be inserted into an endometrial lining of a subject, as called for in independent claims 1, 11, and 34. Accordingly, we reverse the rejection of claims 1-18 and 26-34 under 35 U.S.C. § 103(a) as being unpatentable over Gobby and Bacich. CONCLUSIONS The claims directed to a catheter/apparatus comprising an embryo in the distal portion are directed to patent-ineligible subject matter. The combined teachings of Gobby and Bacich would not have rendered obvious to one of ordinary skill in the art a catheter having a shaft with a tip shaped to be inserted into an endometrial lining of the subject, as claimed. DECISION We AFFIRM the decision of the Examiner to reject claims 30 and 33 under 35 U.S.C. § 101. We REVERSE the decision of the Examiner to reject claims 1-18 and 26-34 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 2011-005321 Application 10/725,623 7 mls