Mayo Foundation for Medical Education and ResearchDownload PDFPatent Trials and Appeals BoardJul 30, 20212021001153 (P.T.A.B. Jul. 30, 2021) 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. 16/154,016 10/08/2018 John W. Sperling 630666.00901 3407 26710 7590 07/30/2021 QUARLES & BRADY LLP ATTN: IP DOCKET 411 E. WISCONSIN AVENUE SUITE 2400 MILWAUKEE, WI 53202-4428 EXAMINER SNOW, BRUCE EDWARD ART UNIT PAPER NUMBER 3774 NOTIFICATION DATE DELIVERY MODE 07/30/2021 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): pat-dept@quarles.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte JOHN W. SPERLING ____________ Appeal 2021-001153 Application 16/154,016 Technology Center 3700 ____________ Before STEFAN STAICOVICI, CARL M. DEFRANCO, and LISA M. GUIJT, Administrative Patent Judges. GUIJT, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 seeks our review under 35 U.S.C. § 134(a) of the rejection of claims 1–3 and 5 under 35 U.S.C. § 103 as being unpatentable over Brunnarius.2,3 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies Mayo Foundation for Medical Education and Research as the real party in interest. Appeal Br. 1. 2 Brunnarius et al. (US 2010/0274359 A1; published Oct. 28, 2010). 3 Claims 7 and 9–29 have been allowed, and claims 4, 6, and 30 are withdrawn. Final Act. 1. Appeal 2021-001153 Application 16/154,016 2 THE INVENTION Appellant’s invention relates to “methods for the optimization of joint arthroplasty component design and shoulder arthroplasty components such as stemless components and fracture stems for joint arthroplasty.” Spec. ¶ 3. Claim 1, reproduced below as the sole independent claim on appeal, is illustrative of the subject matter on appeal. 1. A prosthesis comprising: a central body having a longitudinal axis normal to a reference plane that extends through the central body; a plurality of fins extending laterally from an outer surface of the central body, the plurality of fins being spaced apart around the outer surface of the central body, wherein spacing of the plurality of fins is asymmetric in the reference plane, and wherein all of the plurality of fins do not create bilateral symmetry of all of the plurality of fins with respect to a longitudinal plane containing the longitudinal axis due to the spacing in the reference plane of the plurality of fins. OPINION Claim Construction The Examiner construes the claim language, “wherein all of the plurality of fins do not create bilateral symmetry of all of the plurality of the fins with respect to a longitudinal plane containing the longitudinal axis due to the spacing in the reference plane of the plurality of fins,” to require only that there exists one such longitudinal plane. See Final Act. 6 (“the longitudinal plane containing the longitudinal axis can be arbitrarily chosen” and thus, “[i]nherently, numerous planes maybe chosen to fulfill this limitation”); Ans. 6–7. Appellant submits that “[a]s long as ‘a plane’ may be Appeal 2021-001153 Application 16/154,016 3 oriented to create symmetry, then symmetry inherently exists,” which violates the negative limitation of claim 1. Reply Br. 8. During examination of a patent application, pending claims are given their broadest reasonable construction consistent with the specification. In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). The Specification discloses that “the plurality of fins [are] spaced apart around the outer surface of the central body, wherein spacing of the plurality of fins is asymmetric in the reference plane.” Spec. ¶ 8; see also id. ¶¶ 17, 19, 104; cf. id. ¶ 82 (with reference to Figures 3A–3C, “[t]he spacing of the fins 108, 110, 151, 152, 153, 154 is asymmetric with respect to the reference plane 104); id. ¶ 85 (with reference to Figures 4A, 5A, and 6A, “[t]he fins may be asymmetrically spaced around a central body of the prosthetic component 100A,” wherein “[t]he spacing of the fins around the central body may vary depending upon the desired position of the prosthetic component 100A within the patient”); see also id. ¶¶ 86–94, 107–116 (similarly disclosing that fins may be asymmetrically spaced around a central body of the prosthetic components 100B–100J, 200A–200J); ¶ 184 (“[t]he methodology enables the ability to design patient specific asymmetric implants”). Appellant provides a definition for the term “symmetrical”: “capable of division by a longitudinal plane into similar halves.” Appeal Br. 12 (citing Merriam-Webster; https://www.merriam-webster.com/dictionary/ symmetric). Thus, we understand that Appellant defines “asymmetrical” (or “asymmetric,” as claimed) to mean incapable of division by a longitudinal plane into similar (or identical) halves. We further understand the claim term “bilateral symmetry . . . with respect to a longitudinal plane” to mean Appeal 2021-001153 Application 16/154,016 4 having two similar (or identical) halves when divided by a longitudinal plane. We agree with the Examiner’s claim construction that all that is required by the claim limitation, “wherein all of the plurality of fins do not create bilateral symmetry of all of the plurality of fins with respect to a longitudinal plane containing the longitudinal axis due to the spacing in the reference plane of the plurality of fins,” is that there exists “a” or “one” or “at least one” longitudinal plane (which contains the longitudinal axis of the central body), such that all of the fins do not create bilateral symmetry (or two identical halves) with respect to all of the fins due to the spacing of the fins in the reference plane (which is normal to the longitudinal axis of the central body and in which the fins are asymmetrically spaced), regardless of whether bilateral symmetry of all of the fins exists with respect to different ones of such longitudinal planes. In comparison, we construe the claim limitation, “wherein spacing of the plurality of fins is asymmetric in the reference plane,” to mean that the spaces between the fins are such that it is not possible to divide the prosthesis by a longitudinal plane containing the longitudinal axis into similar (or identical) halves with respect to the placement of the fins in the reference plane. Independent claim 1 Regarding independent claim 1, the Examiner finds that Brunnarius teaches a prosthesis comprising a central body 4 having a longitudinal axis normal to a reference plane and a plurality of laterally extending fins 6, 16, as claimed. Final Act. 4–5 (citing Brunnarius ¶ 52). The Examiner also finds that Brunnarius teaches that “‘in some embodiments, the arms 6 are Appeal 2021-001153 Application 16/154,016 5 distributed unevenly about the body 4 to better suit the non-circular interior profile of the glenoid vault V.’” Id. at 5 (quoting Brunnarious ¶ 32) (emphasis added); see also Brunnarious ¶ 29. The Examiner determines that Brunnarius fails to “specifically state” that the spacing of the fins is asymmetric in the reference plane, as required by claim 1, however, the Examiner’s reasons that it would have been obvious to a skilled artisan to have spaced Brunnarius’ fins to be asymmetric in the reference plane “to better suit or customize to the non-circular interior profile of the glenoid vault of a particular patient.” Id. The Examiner concludes that “[i]t would have been obvious that uneven spacing includes asymmetric spacing,” noting that “[n]owhere does Brunnarius . . . teach the arms are symmetric.” Id. The Examiner further reasons that it would have been obvious to have spaced Brunnarius’ fins so as not to create the bilateral symmetry that is excluded by claim 1, reasoning, again, that to do so would “better suit or customize to the non-circular interior profile of the glenoid vault of a particular patient.” Id. at 6. Appellant argues that “Brunnarius discloses a symmetrical joint prosthesis,” and that the depiction of prostheses in Burnnarius’ figures do not support interpreting Brunnarius’ disclosure of “unevenly” spaced arms (or fins) as asymmetric. Appeal Br. 6–10; see id. at 8 (“the figures and description of Brunnarius all depict and describe symmetrical prostheses”). Appellant submits that “Brunnarius does not teach or suggest an asymmetric implant that would lack bilateral symmetry,” and because “no motivation is provided for how one skilled in the art may create an asymmetric implant based upon the teachings of Brunnarius,” the Examiner improperly relied on hindsight. Id. at 12. Appellant also submits that because “Brunnarius Appeal 2021-001153 Application 16/154,016 6 teaches an unevenly spaced symmetrical implant,” and “the Examiner provides no evidence that asymmetrical implant configurations are ‘better suited to the non-circular interior profile of the glenoid vault of a particular patient’ . . . [,] [the Examiner’s] reasoning “lacks substantial evidence supporting the conclusion [of obviousness].” Id. at 13. In further support, Appellant refers to the declaration of the inventor, John W. Sperling (id. at 15), wherein Mr. Sperling attests that “implant failure is a significant problem” and “asymmetric fin spacing provides an advantage to addressing this problem by providing superior pull-out strength than that provided by conventional, symmetric implants.” Decl. ¶ 4. Mr. Sperling also attests to “the unexpected results” of this comparison. Decl. ¶ 6. We are not persuaded by Appellant’s arguments. Brunnarius discloses, with reference to Figures 1, 2, and 5, that “the four arms 6 are distributed about the body 4, unevenly here, so as to define, between two successive arms 6 around the body 4, an empty passage 63 . . .” (Brunnarius ¶ 29) and that “[i]n some embodiments, the arms 6 are distributed unevenly about the body 4 to better suit the non-circular interior profile of the glenoid vault V” (id. ¶ 32) (emphasis added). We find that at least Figure 2 does not clearly depict whether arms 6 are bilaterally asymmetric or not. Notwithstanding, we agree with the Examiner that Brunnarius certainly does not teach that it is important for arms 6 to maintain a symmetry with respect to a bifurcating plane. Rather, a preponderance of the evidence supports the Examiner’s finding that it would be within the knowledge of a person of ordinary skill in the art to glean from Brunnarius’ teaching of uneven spacing between the arms 6 that an asymmetry with respect to a longitudinal plane may result, as required by Appeal 2021-001153 Application 16/154,016 7 claim 1, because the purpose of the design of the arms of Brunnarius is specifically to better suit the non-circular interior profile of the glenoid value V. In this way, Brunnarius itself provides the support for the Examiner’s proposed modification, to the extent Brunnarius only depicts unevenly spaced, but not asymmetrically spaced, arms. “A reference must be considered for everything that it teaches, not simply the described invention or a preferred embodiment.” In re Applied Materials, Inc., 692 F.3d 1289, 1298 (Fed. Cir. 2012). Regarding the Declaration, Appellant can rebut a prima facie case of obviousness by showing the criticality of the variable (i.e., asymmetric spaces between the fins or location of the fins about the central body in the reference plane). The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . [I]n such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range. In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). See also In re Scherl, 156 F.2d 72, 74–75 (CCPA 1946) (“Where the issue of criticality is involved, the applicant has the burden of establishing his position by a proper showing of the facts upon which he relies.”). Here, the inventor, John W. Sperling, provides test data showing the biomechanical pull-out strength test results of a “Symmetric” implant as compared to an “Asymmetric” implant. See Decl., Graph 1. Mr. Sperling declares that “asymmetric fin spacing, which is not disclosed in the cited reference of Brunnarius, provides for significant resistance to implant failure by being able to withstand twice as much torque at failure as compared to a Appeal 2021-001153 Application 16/154,016 8 symmetrical implant.” Id. ¶ 4. What is unclear from the Declaration, however, is whether the “Symmetric” implants subject to testing included implants with at least uneven spacing, as in Brunnarius, and whether the “Asymmetric” implants had the fins spaced asymmetrically with respect to all reference planes, as required by claim 1. See id. ¶ 2 (“I . . . conducted a biomechanical pull-out strength test comparing commercially-available, symmetrical stemless implants with asymmetrical stemless implants”); see also id. ¶ 4 (“asymmetric fin spacing provides . . . superior pull-out strength than that provided by conventional, symmetric implants”). More importantly, Mr. Sperling merely concludes that “my analysis in Items 4 and 5 above details the unexpected results that is exhibited in the data of Tables 1 and Graph 1 of this study,” without providing sufficient support or explanation as to why such a result was unexpected. Decl. ¶ 6 (emphasis added). In other words, the Declaration fails to show why it would be unexpected to achieve such results, for example, especially in view of the teachings of the prior art: One of the causes of failure or complication with shoulder arthroplasty is connected with poor attachment of the glenoid prosthetic body to the glenoid cavity. When the glenoid cavity of a patient undergoing surgery is worn and/or has an impaired bony makeup, the surgeon has difficulty . . . in firmly attaching the prosthetic body to the glenoid cavity, to ensure that the attachment is sufficiently strong. Brunnarius ¶ 2; see also id. ¶ 32 (“the arms 6 are distributed unevenly about the body 4 to better suit the non-circular interior profile of the glenoid vault V”). Appeal 2021-001153 Application 16/154,016 9 For these reasons, we find that Appellant has not overcome the Examiner’s rejection by rebutting the Examiner’s prima facie case obviousness by presenting sufficient evidence of unexpected results. Accordingly, we sustain the Examiner’s rejection of claim 1. Dependent claim 2 Claim 2 depends from independent claim 1 and recites, in relevant part, “wherein: a first fin . . . has a first fin length, . . . [and] a second fin . . . has a second fin length . . . less than the first fin length.” Appeal Br. A-1 (Claims App.). The Examiner finds that Figures 1 and 3 of Brunnarius depict the subject matter recited in claim 2. Final Act. 6; Ans. 9. Appellant argues that “claim 2 is patentable over the Brunnarius reference in its own regard,” and in support, Appellant recites claim 2. Appeal Br. 16. Appellant also submits that “Brunnarius discloses a symmetrical joint prosthesis,” as argued with respect to claim 1. Id. 4 Appellant’s recitation of claim 2 is insufficient to apprise us of error in the Examiner’s finding, and Appellant’s argument regarding symmetry is unpersuasive for the reasons stated supra. See also In re Lovin, 652 F.3d 4 Appellant argues for the first time in the Reply Brief that “[t]he fins being of different lengths in Brunnarius is . . . shown in a plane parallel to the longitudinal axis rather than normal to the longitudinal axis, as recited by the ‘reference plane’ in the current claims.” Reply Br. 8–9. We decline to consider this argument, as Appellant has not shown good cause as to why the argument was not presented in the Appeal Brief. See 37 C.F.R. § 41.41(b)(2) (2012) (“Any argument raised in the reply brief which was not raised in the appeal brief, or is not responsive to an argument raised in the examiner’s answer, . . . will not be considered by the Board for purposes of the present appeal, unless good cause is shown.”); Ex parte Borden, 93 USPQ2d 1473 (BPAI 2010) (informative). Appeal 2021-001153 Application 16/154,016 10 1349, 1357 (Fed. Cir. 2011) (stating “the Board reasonably interpreted Rule 41.37 to require more substantive arguments in an appeal brief than a mere recitation of the claim elements and a naked assertion that the corresponding elements were not found in the prior art”). Accordingly, we sustain the Examiner’s rejection of claim 2. Dependent claim 3 Claim 3, which depends from claim 1, recites, in relevant part, “wherein the central body has a first opening and a second opening, the first opening corresponding to a proximal side of the central body and the second opening corresponding to a distal side of the central body.” Appeal Br. A-2 (Claims App.). The Examiner finds that Figure 3 of Brunnarius depicts the first and second openings, as claimed. Final Act. 6. Appellant argues that “There is no teaching or suggestion in Brunnarius that device 3 would be anything but symmetrical.” Appeal Br. 16–17. Appellant’s argument regarding symmetry does not apprise us of error in the Examiner’s finding with respect to the subject matter of claim 3. Accordingly, we sustain the Examiner’s rejection of claim 3. Dependent claim 5 Claim 5, which depends from claim 1, recites, in relevant part, “wherein the central body and the plurality of fins are dimensioned for implantation into a humerus of a subject.” Appeal Br. A-2 (Claims App.). The Examiner finds that Brunnarius’ joint prosthesis attachment system is capable of being dimensioned for implantation into a humerus of a subject.” Final Act. 6. Appeal 2021-001153 Application 16/154,016 11 Appellant argues that “Brunnarius does not teach or suggest any application for implantation into a humerus of a subject” and that “the figures and description of Brunnarius are all directed to a glenoid implant.” Appeal Br. 18–19 (citing Brunnarius ¶¶ 23–24). Appellant submits that “the ‘uneven’ spacing disclosed in Brunnarius and relied upon by the Examiner is directly related to the glenoid.” Id. (citing Brunnarius ¶ 32). Appellant concludes that the Examiner has not stated a prima facie case of obviousness for claim 5. Id. 19. Where the Examiner believes the prior art to be capable of performing a recited function, the Examiner must provide sufficient evidence or scientific reasoning to establish the reasonableness of the Examiner's belief that the functional limitation is an inherent characteristic of the prior art. See In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997). Here, Brunnarius discloses generally that “[p]rosthetic systems, devices, and methods for attaching prosthetic joint components to a vault-shaped portion of the anatomy” and does not preclude Brunnarius prosthesis from being dimensioned for implantation into a humerus of a subject, as claimed. Brunnarius, Abstract. We find this is sufficient disclosure to shift the burden to Appellant to distinguish the structure of Appellant’s invention from the structure of Brunnarius’ invention and to explain why it would be beyond the knowledge of a person of ordinary skill in the art to dimension the fins for implantation into a humerus of a subject. Appellant does not undertake to do so. Accordingly, we sustain the Examiner’s rejection of claim 5. Appeal 2021-001153 Application 16/154,016 12 CONCLUSION The Examiner’s rejection of claims 1–3 and 5 is affirmed. DECISISON SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–3, 5 103 Brunnarius 1–3, 5 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). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation