Graham, MichaelDownload PDFPatent Trials and Appeals BoardMay 28, 202015015746 - (D) (P.T.A.B. May. 28, 2020) 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. 15/015,746 02/04/2016 Michael Graham 209.042 6526 30236 7590 05/28/2020 Houtteman Law LLC PO Box 370 Merrifield, VA 22116-0370 EXAMINER PRONE, CHRISTOPHER D ART UNIT PAPER NUMBER 3774 NOTIFICATION DATE DELIVERY MODE 05/28/2020 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): USPTO@dockettrak.com ibgamboa@houtteman.com wangxuzhuo@yahoo.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte MICHAEL GRAHAM ____________________ Appeal 2019-0053291 Application 15/015,746 Technology Center 3700 ____________________ Before PHILLIP J. KAUFFMAN, TARA L. HUTCHINGS, and ALYSSA A. FINAMORE, Administrative Patent Judges. FINAMORE, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant2 appeals from the Examiner’s decision to reject claims 1–13. We have jurisdiction under § 6(b). We AFFIRM. 1 The citations herein refer to the Specification filed February 4, 2016 (“Spec.”), Final Office Action mailed May 30, 2018 (“Final Act.”), Appeal Brief filed January 30, 2019 (“Appeal Br.”), Examiner’s Answer mailed May 17, 2019 (“Ans.”), and Reply Brief filed July 2, 2019 (“Reply Br.”). 2 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the inventor, Michael Graham, as the real party in interest. Appeal Br. 1. Appeal 2019-005329 Application 15/015,746 2 SUBJECT MATTER ON APPEAL The invention relates to “a medical apparatus for enhancing and for correcting skeletal mechanics,” and, more specifically, “the correction of certain bone alignment deformities that impair optimal biped mechanics.” Spec. ¶ 1. Claim 1, the sole independent claim, is illustrative of the subject matter on appeal, and reproduced below with italics to emphasize the limitation at issue. 1. A sinus tarsi implant for use in correcting anatomical alignment of a patient’s ankle bone structure comprising: a cylindrical body portion consisting of a cylindrical side surface, a circular medial end and a circular lateral end, said medial and lateral ends being perpendicular to an implant central axis, said cylindrical side surface comprising a plurality of grooves each perpendicular to the implant central axis, and a conical foot portion comprising a generally conical side surface, a circular top and circular base, said top being integrally connected, along the implant central axis, with the lateral end of the body portion, said conical side surfaces flare out to form an angle, θ, wherein θ is in the range 15° to 25° wherein said implant is capable of insertion into a patient’s ankle and corrects anatomical alignment of the patient’s ankle bone structure. Appeal Br., Claims App. (emphasis added). Appeal 2019-005329 Application 15/015,746 3 REJECTIONS Claim(s) Rejected 35 U.S.C. § References/Basis 1–3, 5, 9–13 103 Graham,3 Zang4 4 103 Graham, Zang, Rappaport5 6, 8 103 Graham, Zang, Zang ʼ1656 7 103 Graham, Zang, Zang ʼ165, Rappaport ANALYSIS Objections to the Drawings In addition to the claim rejections, the Examiner objects to the drawings. Final Act. 3–4. Specifically, the Examiner objects to the drawings under 37 C.F.R. § 1.83 because they do not show the convex, hemispherical, and concave conical side surfaces recited in claims 11–13. Id. at 3. The Examiner further objects to Figure 6, which Appellant submitted to illustrate the subject matter of claims 11–13, as containing new matter. Id. at 3–4. Appellant seeks appellate review of the drawing objections. Appeal Br. 4–5; Reply Br. 2–4. According to Appellant, appellate review is appropriate for two reasons: (1) in objecting to Figure 6 for containing new matter, the Examiner is interpreting a patent statute, 35 U.S.C. § 132; and (2) the Examiner is indirectly rejecting claims 11–13 by insisting that the unillustrated features be omitted from the claims. Reply Br. 2–4. 3 Graham, US 2005/0187636 A1, published Aug. 25, 2005. 4 Zang, US 5,522,843, issued June 4, 1996. 5 Rappaport, US 4,450,591, issued May 29, 1984. 6 Zang et al., US 2005/0177165 A1, published Aug. 11, 2005 (“Zang ’165”). Appeal 2019-005329 Application 15/015,746 4 The Board may review adverse decisions of Examiners which “relate, at least indirectly, to matters involving the rejection of claims.” In re Hengehold, 440 F.2d 1395, 1404 (CCPA 1971). The Examiner’s objections to the drawings are premised on whether the drawings depict the subject matter of claims 11–13 without introducing new matter. Final Act. 3–4. In contrast, the claim rejections involve the obviousness of the claimed subject matter under 35 U.S.C. § 103. Id. at 5–8. Notably, the Examiner confirms there are no new matter issues for the claims. The Examiner finds that “the claimed convex/hemispherical side surfaces (Claims 11-13) are supported within the originally filed claims so they are not considered new matter” (Final Act. 3), and that “[s]hould Figure 6 had been originally filed it likely would have been sufficient to support the claims” (id. at 4). Although the Examiner’s finding that Figure 6 supports the claims appears to abrogate the objections to the drawings, the drawing objections, nonetheless, are unrelated to the claim rejections. Thus, review of the Examiner’s objections to the drawings is a petitionable matter, not an appealable one. See Ex parte Frye, 2010 WL 889747 at *7–8 (BPAI 2010) (precedential) (holding the review of the Examiner’s objection to the drawings under 37 C.F.R. § 1.83(a) and the Examiner’s refusal to enter Appellant’s proposed amended drawings is a petitionable matter). Obviousness Based on Graham and Zang Appellant argues claims 1–3, 5, and 9–13 as a group. Appeal Br. 5–9; Reply Br. 4–7. We select independent claim 1 as representative, and claims 2, 3, 5, and 9–13 stand or fall with independent claim 1. 37 C.F.R. § 41.37(c)(1)(iv). Appeal 2019-005329 Application 15/015,746 5 In rejecting independent claim 1, the Examiner finds Graham discloses almost all of the claim limitations. Final Act. 5. In particular, the Examiner finds Graham discloses a sinus tarsi implant having a cylindrical side surface with grooves, i.e., channels 112. Id. Figure 4, reproduced below, shows Graham’s sinus tarsi implant, including channels 112. Figure 4 is a side view of sinus tarsi implant 100. Graham ¶¶ 31, 37. As shown in Figure 4, implant 100 includes cone-shaped first member 106 and second member 108 longitudinally attached to first member 106 at the smaller end of the cone. Id. ¶ 39, Figs. 3, 4. Second member 108 has an outer surface that is generally cylindrical in shape and includes a series of one or more channels 112. Id. ¶ 41, Fig. 4. The Examiner acknowledges Graham does not disclose grooves that are perpendicular to the implant central axis, as independent claim 1 requires. Final Act. 5. The Examiner finds Zang teaches a bone anchor having grooves that are perpendicular to the central axis. Id.; see also Ans. 7 (the Examiner’s annotated version of Zang’s Figure 4 identifying the Appeal 2019-005329 Application 15/015,746 6 perpendicularly extending grooves). Zang’s Figures 3, 4 and 6, reproduced below, show the bone anchor. Figure 3 is a side elevational view of the bone anchor, and Figure 4 is a cross-section view of the bone anchor taken along line IV-IV of Figure 3. Zang 3:27–31. Figure 6 is an end view of the bone anchor. Id. at 3:35–36. As shown in Figures 3 and 4, shaft portion 44 includes a plurality of Appeal 2019-005329 Application 15/015,746 7 frustoconical tines 46A–46F forming grooves that are perpendicular to the central axis of the bone anchor. Id. at 4:63–67. As shown in Figures 3 and 6, tines 46A–46F are divided into tine sections 74A–74C by vertical grooves 72A–72C running parallel to the central axis of the bone anchor. Id. at 5:18–21. According to the Examiner, it would have been obvious to replace Graham’s channels with the perpendicular grooves and protrusions of Zang to provide an anchor that resists twisting and backing out. Final Act. 5. Appellant argues a person of ordinary skill in the art would have looked to Zang’s grooves 72A–72C, not tines 46A–46F, for teaching the grooves recited in independent claim 1. Appeal Br. 6; Reply Br. 5–6. Appellant further contends grooves 72A–72C do not teach the recited grooves because grooves 72A–72C are oriented lengthwise, not perpendicular to the central axis as independent claim 1 requires. Appeal Br. 6; Reply Br. 5–6. Although we agree with Appellant that Zang expressly teaches grooves 72A–72C, the Examiner nonetheless relies on tines 46A–46F for teaching the recited grooves. Final Act. 5; see also In re Bond, 910 F.2d 831, 832 (Fed. Cir. 1990) (explaining there is no ipsissimis verbis test for determining whether a reference discloses a claim element, i.e., identity of terminology is not required). Accordingly, whether grooves 72A–72C teach the recited grooves is inconsequential. Appellant additionally argues Zang’s frustoconical tines 46A–46F are not grooves. Appeal Br. 5–6; Reply Br. 4–6. According to Appellant, Zang’s tines do not extend lengthwise to form grooves because they are interrupted by vertical grooves 72A–72C. Reply Br. 5; see also id. (“[T]he ‘grooves’ do not extend!”). Even with this interruption, however, each of Appeal 2019-005329 Application 15/015,746 8 tine sections 74A–74C includes grooves that extend between two of vertical grooves 72A–72C. Zang, Figs. 3, 4, 6. More to the point, independent claim 1 does not preclude such an interruption. The claim recites “a plurality of grooves each perpendicular to the implant central axis.” Appeal Br., Claims App. As shown in Figures 3 and 4, tines 46A–46F form grooves extending perpendicularly to the central axis. Zang, Figs. 3, 4; see also Ans. 7 (the Examiner’s annotated version of Zang’s Figure 4). Appellant also argues a sinus tarsi implant is not a bone anchor. Appeal Br. 6–7; Reply Br. 6–7. According to Appellant, a sinus tarsi implant allows for normal articulation between the ankle and heel bones, whereas Zang’s bone anchor prohibits movement between the bones being anchored. Appeal Br. 6–7; Reply Br. 6–7. Appellant further argues “it is only through hindsight reasoning . . . that the Examiner finds motivation to combine [Zang] with the prior art Graham device.” Appeal Br. 7. Appellant argues as if the rejection proposes to use a bone anchor as a sinus tarsi implant. Such is not the case. Rather, as explained above, Graham discloses a sinus tarsi implant, and the Examiner proposes to modify Graham to have tine segments as taught by Zang. Moreover, although a sinus tarsi implant differs in some respects from a bone anchor, a sinus tarsi implant and a bone anchor need to be properly positioned and secured within a patient’s body. Both Graham’s sinus tarsi implant and Zang’s bone anchor have grooves for positioning and securement. In particular, Graham discloses: “The second member provides the important function of anchoring the implant 100 in place and preventing collapse of the canalis tarsi canal. The channeling or threading serves to operably engage the surrounding soft tissue and ligaments and thus firmly Appeal 2019-005329 Application 15/015,746 9 and permanently anchors the implant in place.” Graham ¶ 42. Similarly, Zang teaches “[t]o the extent anchor 40 frictionally engages the bone during insertion, the outward flaring of respective tine segments 46A–46F (and particularly in the region of respective arcuate junctions 50) with respect to the bone proximate thereto will inhibit outward axial migration of anchor 40.” Zang 7:22–27. As set forth above, the Examiner proposes to replace Graham’s channels with the perpendicular grooves and protrusions of Zang to prevent twisting and backing out. Final Act. 5. Indeed, Zang’s tines 46A–46F inhibit backing out, and the Examiner is essentially substituting Graham’s securement means for that of Zang. Zang 7:22–27; see also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” (citation omitted)). Appellant, therefore, does not apprise us of error in the Examiner’s reason for the combining the teachings of Graham and Zang. Appellant further contends the claimed invention provides unexpected results, as evidenced by the Knight Report included as Appendix 1 with the Appeal Brief. Appeal Br. 7–9; Reply Br. 7. Per Appellant, the standard axial pullout test for metallic medical bone screws, namely ASTM F543-13, demonstrates the claimed invention is superior to the closest prior art. Appeal Br. 7. Specifically, Appellant alleges: The average pullout force of the claimed device was 683.7 N. This is significantly greater than the pull out force of the prior art device, 544.7 N. (See results, p. 4). Moreover, while the prior art implant was pulled out of the block, the claimed implant, in every case, could not be pulled out of the foam block until the foam block fractured! See photographs on page 7). Appeal 2019-005329 Application 15/015,746 10 Id. (citing Knight Report 4, 7). “Mere improvement in properties does not always suffice to show unexpected results.” In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995). The claimed invention must “exhibit[] some superior property or advantage that a person of ordinary skill in the relevant art would have found surprising or unexpected.” Id. at 750; see also In re Merck & Co., 800 F.2d 1091, 1098–99 (Fed. Cir. 1986) (analyzing whether the improvement was expected or unexpected). “[W]hen an applicant demonstrates substantially improved results, . . . and states that the results were unexpected, this should suffice to establish unexpected results in the absence of evidence to the contrary.” In re Soni, 54 F.3d at 751; see also In re Geisler, 116 F.3d 1465, 1471 (Fed. Cir. 1997) (applying this rule). Furthermore, “[i]t is well settled that unexpected results must be established by factual evidence. Mere argument or conclusory statements in the specification does not suffice.” In re Soni, 54 F.3d at 750 (quoting In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984); see also In re Geisler, 116 F.3d at 1471 (holding that naked attorney argument is insufficient to establish unexpected results). As shown on page 4 of the Knight Report, the HYP II-07 Specimen, which Appellant asserts is the claimed invention, has an axial pullout force of 683.7 N, and the HYP-05 Specimen, which Appellant considers the closest prior art device, has an axial pullout force of 544.7 N. Thus, the Knight Report demonstrates that the HYP II-07 Specimen provides a 25.5% improvement in axial pullout force. This evidence alone, however, does not constitute proof of “substantially improved results.” See In re Geisler, 116 F.3d at 1471 (explaining a 26% improvement, without more, is not proof of “substantially improved results”). Appellant asserts the pullout force for the Appeal 2019-005329 Application 15/015,746 11 HYP II-07 Specimen is “significantly greater” than the pullout force for the HYP-05 Specimen. Appeal Br. 7. This assertion, however, is attorney argument, not the requisite factual evidence. Turning to whether “the results were unexpected,” Appellant characterizes the pullout force associated with the HYP II-07 Specimen as “unexpectedly strong resistance to ‘pull out.’” Appeal Br. 7, 9. Such a characterization is simply attorney argument. Furthermore, unlike the HYP-05 Specimen, which includes a continuous thread for securing the implant, the HYP II-07 Specimen includes a plurality of grooves extending perpendicularly to the implant’s central axis for securing the implant. As set forth above, Zang teaches tines 46A–46F creating grooves perpendicular to the central axis, and Zang explicitly explains that the tines “inhibit outward axial migration.” Zang 7:22–27, Figs. 3, 4. Consequently, in view of the prior art, the improved axial pullout force appears to be an expected result. For these reasons, Appellant has not demonstrated that the claimed invention provides “substantially improved results” or that “the results were unexpected.” Appellant’s evidence of unexpected results is weak. Weighing the Examiner’s evidence of obviousness against Appellant’s evidence of nonobviousness, Appellant does not apprise us of error in the Examiner’s determination that the subject matter of independent claim 1 would have been obvious over the combined teachings of Graham and Zang. We, therefore, sustain the rejection of independent claim 1, with claims 2, 3, 5, and 9–13 falling therewith. Appeal 2019-005329 Application 15/015,746 12 Obviousness Based on Graham, Zang, and Rappaport and/or Zang ’165 Appellant does not present separate arguments for claims 4 and 6–8 apart from its arguments for independent claim 1. Appeal Br. 5–9; Reply Br. 4–7. For the same reasons as independent claim 1, we sustain the rejections of claims 4 and 6–8. CONCLUSION We sustain the rejections of claims 1–13. DECISION SUMMARY Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–3, 9–13 103 Graham, Zang 1–3, 9–13 4 103 Graham, Zang, Rappaport 4 6, 8 103 Graham, Zang, Zang ʼ165 6, 8 7 103 Graham, Zang, Zang ʼ165, Rappaport 7 Overall Outcome 1–13 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