Ex Parte Berry et alDownload PDFPatent Trial and Appeal BoardFeb 8, 201812339766 (P.T.A.B. Feb. 8, 2018) Copy Citation 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. 12/339,766 12/19/2008 Bret M. Berry 641-10 7798 27538 7590 02/12/2018 frihsinn Rr Dernier T T P EXAMINER 89 Headquarters Plaza North PMB 1469 SCHALL, MATTHEW WAYNE Morristown, NJ 07960 ART UNIT PAPER NUMBER 3738 NOTIFICATION DATE DELIVERY MODE 02/12/2018 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): info@gdiplaw.com cmburgos @gdiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BRET M. BERRY, RICHARD D. GUYER, JACK E. ZIGLER, ADAM A. PIKE, and RANDALL F. LEE1 Appeal 2017-002879 Application 12/339,766 Technology Center 3700 Before ULRIKE W. JENKS, RICHARD J. SMITH, and TIMOTHY G. MAJORS, Administrative Patent .Judges. SMITH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to an intervertebral prosthesis. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. STATEMENT OF THE CASE Background “The present disclosure generally relates to apparatus and methods for treatment of spinal disorders using an intervertebral prosthesis which is 1 According to Appellants, the real party in interest is Amicus, LLC. (Br. 2.) Appeal 2017-002879 Application 12/339,766 disposed in an intervertebral space (or cavity) following removal of a damaged or diseased intervertebral disc.” (Spec. 11.) Claims on Appeal Claims 1—21 are on appeal. (Br. 14—18 (Claims Appendix).) Claims 1 and 21, the only independent claims, are illustrative and read as follows (emphases added): 1. An intervertebral prosthesis, comprising: a body including first and second spaced apart major surfaces and at least anterior and posterior sidewalls extending therebetween, the first major surface for engaging an endplate of a first vertebral bone of a spine, and the second major surface for engaging an endplate of an adjacent, second vertebral bone of the spine, and the first and second major surfaces defining a longitudinal axis extending substantially normal to said surfaces; a first aperture extending from within the body, transversely with respect to the longitudinal axis, and opening at the first major surface; a first anchoring element disposed within the first aperture and including a threaded shaft having proximal and distal ends; and a first gear disposed adjacent to and in meshed, threaded communication with the threaded shaft of the first anchoring element such that rotation of the first gear causes rotation of the first anchoring element, wherein a driving rotational force on the first gear causes the first anchoring element to rotate, deploy from the body, and thread into the first vertebral bone in a direction transverse to the longitudinal axis of the body and the spine. {Id. at 14.) 21. An intervertebral prosthesis, comprising: a body including first and second spaced apart major surfaces and at least anterior and posterior sidewalls extending therebetween, the first major surface for engaging an endplate 2 Appeal 2017-002879 Application 12/339,766 of a first vertebral bone of a spine, and the second major surface for engaging an endplate of an adjacent, second vertebral bone of the spine, and the first and second major surfaces defining a longitudinal axis extending substantially normal to said surfaces; and at least one anchoring element disposed within an aperture within the body and including a threaded shaft, the at least one anchoring element operating to deploy from the body in response to a driving rotational force and thread into the first vertebral bone in a direction transverse to the longitudinal axis of the body and the spine. (Id. at 18.) Examiner’s Rejections 1. Claims 1—21 stand rejected under 35 U.S.C. § 112, second paragraph, as being indefinite. (Ans. 4—5.) 2. Claims 1—21 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Moskowitz2 and Michelson.3 (Id. at 5—6.) DISCUSSION Rejection No. 1 Issue Whether a preponderance of evidence of record supports the Examiner’s rejection under Section 112. Analysis The Examiner contends that “[t]he term ‘transverse’ in claims 1 and 21 is used by the claims to mean ‘extending at an angle less than 90 degrees 2 Moskowitz et al., US 2007/0049943 Al, pub. March 1, 2007 (“Moskowitz”). 3 Michelson, US 6,749,636 B2, issued June 15, 2004. 3 Appeal 2017-002879 Application 12/339,766 away from the longitudinal axis of the device’, while the accepted meaning is ‘at a right angle from the longitudinal axis of the device.’” (Ans. 4—5.) Although the Examiner agrees with Appellants that Merriam Webster’s Collegiate Dictionary defines “transverse” as “(1) acting, lying or being across; set crosswise, and/or (2) made at right angles to the anterior/posterior axis of the body,” {id. at 6), according to the Examiner, “[o]ne of the definitions in Merriam-Webster[’s] dictionary defines the term as ‘made at right angles to the long axis of the body’” {id. at 5) (i.e. definition (2)). The Examiner thus finds that “[t]he term [transverse] is indefinite because the specification does not clearly redefine the term.” {Id.) Appellants contest the rejection, relying on the Berry Declaration.4 (Br. 6—10.) Appellants argue that “[t]here should be no dispute as to the actual accepted definition of the term ‘transverse,’ i.e., the definition encompasses two axes or members ‘crossing’ one another at an angle within a range of greater than 0 and including 90 degrees.” {Id. at 8, citing Decl. 1 6.) Appellants further argue that “the claims call for a configuration that is both supported by the written description, the drawing, and the actual accepted definition of ‘transverse’.” (Id. ) We find that Appellants have the better position. The conjunction “and/or,” used in the definition of “transverse” agreed to by the Examiner and Appellants, is “used as a function word to indicate that two words or expressions are to be taken together or individually.”5 As applied to the 4 Declaration of Bret M. Berry, dated July 5, 2012 (“Berry Declaration” or “Decl.”). 5 Meriam-Webster.com, https://www.merriam- webster.com/dictionary/and/or (last visited Jan. 31, 2018). 4 Appeal 2017-002879 Application 12/339,766 definition of “transverse,” that definition is thus understood to include all three of definitions (1) or (2), or both (1) and (2). Here, definition (1) (acting, lying, or being across; set crosswise) is consistent with Appellants’ use of the term “transverse.” Accordingly, we find that the term “transverse,” as used by Appellants in claims 1 and 21, is sufficiently clear to a person of ordinary skill in the art. See In re Packard, 751 F.3d 1307, 1313 (Fed. Cir. 2014); see also Ex parte McAward, Appeal 2015-006416, 2017 WL 3669566, at *5 (PTAB Aug. 25, 2017) (precedential) (adopting the approach for assessing indefmiteness approved by the Federal Circuit in Packard). The Examiner’s rejection of claims 1—21 under Section 112, second paragraph, is reversed. Rejection No. 2 Issue Whether a preponderance of evidence of record supports the Examiner’s rejection under 35 U.S.C. § 103(a). Analysis The Examiner finds that Moskowitz discloses “an intervertebral prosthesis comprising a body with first and second major surfaces, apertures in the surfaces, and anchoring elements [screws] (102) (103) threaded with gears (202) and capable of deploying from the body and threading into vertebral bone.” (Ans. 5, citing Moskowitz Figure 1A and 140.) The Examiner further finds that, although Moskowitz does not disclose the screws deploying at an angle from the longitudinal axis, “Michelson teaches an intervertebral prosthesis with screws deploying at an angle from the body 5 Appeal 2017-002879 Application 12/339,766 of the device and into vertebral bone, in the same field of endeavor, for the purpose of securing the device.” (Ans. 5, citing Michelson Figures 23—27 and col. 9,11. 5—20.) Based on those findings, the Examiner concludes that “[i]t would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the implant of Moskowitz to have the angled screws of Michelson, in order to secure the device in place.” (Ans. 6.) Appellants contest the rejection, and rely on the Berry Declaration. (Br. 5—6, 11—13.) In particular, Appellants argue that the Examiner has not addressed the Berry Declaration or provided any rebuttal or other response to the statements in the Berry Declaration. (Br. 11.) We separately address the rejection of independent claims 1 and 21. Claim 1 Claim 1 recites, in pertinent part, “a first anchoring element. . . and a first gear disposed adjacent to and in meshed, threaded communication with the threaded shaft of the first anchoring element.” (Br. 14.) The Berry Declaration states that “neither . . . [Moskowitz] nor . . . [Michelson] provides disclosure of a suitable gear mechanism that would be required to achieve the modification that the Examiner concludes is obvious.” (Decl. 114.) The Berry Declaration further states that “any attempt to take the axes of the spur gear 202 and either screws 102, 103 [(Moskowitz Fig. 2)] out of parallel (as would be required in order to deploy as illustrated in [Michelson]) would cause the illustrated gearing therebetween to bind.” (Decl. 115.) 6 Appeal 2017-002879 Application 12/339,766 Notwithstanding Appellants’ clear reliance on the Berry Declaration, the Examiner’s Answer fails to address the Berry Declaration or Appellants’ arguments with respect thereto. (See Ans. 3—7.) However, after a successful Petition by Appellants, the Berry Declaration was entered by the Examiner more than four years after the Berry Declaration was filed. (Advisory Action dated Aug. 19, 2016.) At that time, the Examiner stated that “the affidavit filed 7/23/2012 is entered for appeal purposes, however the opinions in the affidavit are not persuasive.” (Id.) On this record, we do not find the Examiner’s cursory response to be sufficient to persuasively address the Berry Declaration, particularly as it relates to the gear mechanism as recited in claim 1. Here, the Examiner provides no reasoning as to why “the opinions in the affidavit are not persuasive.” Accordingly, we reverse the rejection of claim 1 and dependent claims 2—20, all of which depend directly or indirectly on claim 1. Claim 21 We discern no error in the Examiner’s rejection of claim 21 for obviousness. Although Appellants acknowledge that “claims 1 and 21 are of differing scope,” Appellants incorrectly assert that claim 21 includes “a first gear disposed adjacent to and in meshed, threaded communication with the threaded shaft.” (Br. 12.) Rather, the pertinent structure recited in claim 21 is limited to “at least one anchoring element disposed within an aperture within the body and including a threaded shaft.” (Br. 18.) No gear mechanism is recited, and the “driving rotational force” recited in claim 21 to deploy the anchoring element may be applied directly to the anchoring 7 Appeal 2017-002879 Application 12/339,766 element with (for example) a wrench or screw driver. Thus, Appellants’ reliance on arguments and the Berry Declaration regarding a gear mechanism are unavailing as to claim 21. Appellants also argue that Moskowitz and Michelson are not enabled, citing Manual of Patent Examining Procedure (“MPEP”) § 2121.01. (Br. 12.) However, that argument is unpersuasive because the cited section of the MPEP clearly states that “a non-enabling reference may quality as prior art for the purpose of determining obviousness under [35 U.S.C. § 103].” (MPEP § 2121.01, quoting Symbol Techs., Inc. v. Opticon, Inc., 935 F.2d 1569, 1578 (Fed. Cir. 1991).) Accordingly, for the reasons of record and as set forth above, we affirm the rejection of claim 21. Conclusions A preponderance of evidence of record fails to support the Examiner’s rejection of claims 1—21 under 35 U.S.C. § 112, second paragraph. A preponderance of evidence of record fails to support the Examiner’s rejection of claims 1—20 under 35 U.S.C. § 103(a). A preponderance of evidence of record supports the Examiner’s rejection of claim 21 under 35 U.S.C. § 103(a). SUMMARY The rejection of claim 21 under Section 103(a) is affirmed, and the rejections of claims 1—21 under Section 112, second paragraph, and claims 1—20 under Section 103(a), are reversed. 8 Appeal 2017-002879 Application 12/339,766 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED-IN-PART 9 Copy with citationCopy as parenthetical citation