Ex Parte Kibbe et al

Patent Trial and Appeal BoardJun 12, 2017

13641378 (P.T.A.B. Jun. 12, 2017)

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. 13/641,378 12/04/2012 Melina R. Kibbe 5369-00057 7223 26753 7590 06/14/2017 Andrus Intellectual Property Law, LLP 100 EAST WISCONSIN AVENUE, SUITE 1100 MILWAUKEE, WI 53202 EXAMINER SCHALL, MATTHEW WAYNE ART UNIT PAPER NUMBER 3738 NOTIFICATION DATE DELIVERY MODE 06/14/2017 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): patentdocketing @ andruslaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MELINA R. KIBBE and GUILLERMO A. AMEER1 Appeal 2016-004409 Application 13/641,378 Technology Center 3700 Before FRANCISCO C. PRATS, ULRIKE W. JENKS, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. JENKS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims directed to a stent. The Examiner rejects the claims as anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 According to Appellants, the Real Party in Interest is Northwestern University. Appeal Br. 1. Appeal 2016-004409 Application 13/641,378 STATEMENT OF THE CASE Claims 1 and 4—12 are on appeal, and can be found in the Claims Appendix of the Appeal Brief. Claim 1 is representative of the claims on appeal, and reads as follows: 1. A liquid cast biodegradable arterial stent, wherein the stent comprises a biodegradable polymer and the stent is formed by curing in situ a solution comprising prepolymers or monomers that polymerize or cross-link to form the biodegradable polymer. Appellants request review of the Examiner’s rejection of claims 1 and 4—12 as anticipated by Daniloff.2 The issue is: Does the preponderance of evidence of record support the Examiner’s finding that Daniloff anticipates claim 1? Findings of Fact FF1. Daniloff teaches that “[cjrosslinkable compositions are provided that readily crosslink in situ to provide crosslinked biomaterials.” Daniloff Abstract. Compositions “can be injected or otherwise applied to a specific site within a patient’s body, e.g., a site in need of augmentation, and allowed to crosslink at the site of injection.” Id. 1 75. Once inside the patient’s body, the reactive groups on the components inter-react with each other to form a three- dimensional matrix in situ. . . . some of the reactive electrophilic groups may also react with primary amino groups on lysine residues of collagen molecules within the patient’s own tissue, providing for “biological anchoring” of the composition with the host tissue. Id. 1583. 2 Daniloff et al., US 2005/0281883 Al, published Dec. 22, 2005 (“Daniloff’). 2 Appeal 2016-004409 Application 13/641,378 FF2. Daniloff teaches that: medical implants may be coated with, or otherwise adapted to release or incorporate an agent which inhibits the formation of reactive scar tissue on, or around, the surface of the device or implant. . . . Compositions and methods are described for coating medical devices and implants with drug-delivery compositions. Id. 1 628. “Examples of medical devices of particular utility for use in combination with a fibrosis-inhibiting agent include, but are not restricted to vascular stents.” Id. 1 630. Principles of Law “In determining validity of a product-by-process claim, the focus is on the product and not the process of making it.” Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1369 (Fed. Cir. 2009). Nonetheless, “if the process by which a product is made imparts structural and functional differences distinguishing the claimed product from the prior art, then those differences are relevant as evidence of no anticipation although they are not explicitly part of the claim.” Greenliant Systems, Inc. v. XicorLLC, 692 F.3d 1261, 1268 (Fed. Cir. 2012) (internal quotations omitted). As the court explained in Greenliant, “[consistent with our precedent, the Patent Office in determining patentability considers the process in which a product is formed if that process imparts distinctive structural characteristics . . . .” Id. (citing MPEP § 2113) (emphasis added) Analysis The Examiner interprets that the claimed limitations of “liquid cast” and “cured in situ” are product-by-process limitations and as such are “not 3 Appeal 2016-004409 Application 13/641,378 construed as being limited to the product formed by the specific process recited.” Ans. 3. For the following reasons, we agree with the Examiner that the recited limitations are product-by-process limitations. We first turn to the preamble to determine if limitations therein are necessary for the proper construction of the claim. We determine that the preamble reciting “liquid cast” is not further limiting because it does not add limitations to the body of the claim. “If the preamble adds no limitations to those in the body of the claim, the preamble is not itself a claim limitation and is irrelevant to proper construction of the claim.” IMS Technology, Inc. v. Haas Automation, Inc., 206 F.3d 1422, 1434 (Fed. Cir. 2000). Here, the body of the claim recites that the stent is formed by curing a solution (also known as a liquid) of prepolymers and monomers. Thus, the preamble reciting “liquid cast” does not add limitations to the body of the claim, because the body of the claim already tells us to cure the solution and thereby the preamble is not further limiting. In addition, we also agree with the Examiner’s position that “liquid cast” is reasonably interpreted to be a process limitation. “Liquid cast” tells the relevant audience that the process involves the use of a liquid and mold. As such, we agree with the Examiner position that the limitation “liquid cast” as found in the preamble is a product-by-process limitation. The Examiner also finds that the limitation “cured in situ” is also a product-by-process limitation. We find no error with this interpretation as well. Based on the Examiner’s reasonable interpretation that the claim terms “liquid cast” and “cured in situ” are product-by-process limitations, the Examiner concludes that the claim is anticipated by a stent that is coated 4 Appeal 2016-004409 Application 13/641,378 with a biodegradable polymer. Ans. 2 (“[cjlaim 1 simply requires a stent comprising a biodegradable polymer. A coating on a stent rejects this claim language”); FF1 andFF2. Appellants contend that curing the stent in situ imparts distinctive structural characteristics to the stent. Appeal Br. 6. “[B]y forming the claimed stent from pre-polymers and monomers that polymerize in situ, the outer surface of the stent thus formed will mirror the interior of the arterial wall and the stent will more precisely fit within the artery than a stent formed from a polymer made ex situ and subsequently placed in the artery.” Appeal Br. 14. Additionally, Appellants contend that a stent formed with a polymer in situ will allow the polymer to chemically react with the inner arterial wall to more firmly anchor the stent. See Id.', see also FF1 (“electrophilic groups may also react with primary amino groups on lysine residues of collagen molecules within the patient’s own tissue, providing for “biological anchoring” of the composition with the host tissue”). We find that Appellants have the better position. Appellants have directed us to structural differences between stent formed in situ versus stents produced by other means. Specifically, a stent cured in place will take on the shape of the environment in which the polymer is cured. The Examiner’s response does not address the structural aspect raised by Appellants. Because there are structural differences imparted to the product by the process of making the product, we do not find anticipation based on Daniloff. See Greenliant Systems, Inc. v. XicorLLC, 692 at 1268. Accordingly, we reverse the anticipation rejection based on Daniloff. REVERSED 5