Ex Parte Felix et al

Patent Trial and Appeal BoardJul 9, 2018

13063605 (P.T.A.B. Jul. 9, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/063,605 22913 7590 Workman Nydegger 60 East South Temple Suite 1000 03/11/2011 07/11/2018 Salt Lake City, UT 84111 FIRST NAMED INVENTOR Brent A. Felix 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 16312.13a.7 4134 EXAMINER JOHANAS, JACQUELINE T ART UNIT PAPER NUMBER 3733 NOTIFICATION DATE DELIVERY MODE 07/11/2018 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): Docketing@wnlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte BRENT A. FELIX, DAVID N. MCKEAN, and DAVID A. HERSHGOLD 1 Appeal2017-007159 Application 13/063,605 Technology Center 3700 Before RICHARD M. LEBOVITZ, JOHN E. SCHNEIDER, and RYAN H. FLAX, Administrative Patent Judges. FLAX, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. Â§ 134(a) involving claims to a bone screw and method of manufacturing a bone screw. The Examiner's rejection of claims 54--56, 58---62, 64---66, 74, and 76-79 under 35 U.S.C. Â§ 103(a) is appealed. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We affirm-in-part and set forth a new ground of rejection under 35 U.S.C. Â§ 103(a), pursuant to our authority under 37 C.F.R. Â§ 4 l .50(b ). 2 1 The Real Party in Interest is identified as "Innovasis, Inc." Appeal Br. 2. 2 We have considered, and herein refer to, the Specification of Mar. 11, 2011 ("Spec."); Final Office Action of Jan. 7, 2016 ("Final Action"); Appeal Brief Appeal2017-007159 Application 13/063,605 STATEMENT OF THE CASE The Background of the Specification states: because [conventional] bone screws are made of metal, the bone screws block X-rays passing through the body, in effect obscuring adjacent bone and other X-ray viewable internal structures surrounding the area and thereby preventing the surgeon from viewing those structures on an X-ray photograph. The metal bone screws can also disrupt MRI and other types of images. This can limit a surgeon's ability to ensure proper placement of the bone screws and diagnose and treat problems that arise near the location of the bone screws after the bone screws have been implanted. Spec. ,r 4. Independent claims 54 and 66, reproduced below, are representative: 54. A bone screw comprising: an elongate shaft extending longitudinally between a proximal end and an opposing distal end, the shaft bounding a first passageway at least partially extending between the proximal end and the distal end, the shaft being comprised of a radiolucent material; a core disposed within the first passageway of the shaft, the core being comprised of a radiopaque material that comprises a metal, that shaft being comprised of a prefabricated sheet comprised of the one or more radio lucent fibers and an adhesive that encircles the radiopaque core so that the one or more radiolucent fibers radially encircling the core; an enlarged head disposed at an end of the core and being comprised of the same radiopaque material as the core, the core and the head being integrally formed as a single, one piece, unitary member, the enlarged head having a maximum diameter that is larger than a maximum diameter of the core; and of Sept. 6, 2016 ("Appeal Br."); and Examiner's Answer of Jan. 12, 2017 ("Answer"). No Reply Brief was submitted. 2 Appeal2017-007159 Application 13/063,605 a helical thread recessed into the pre-fabricated sheet encircling the radiopaque core. 66. A method of manufacturing a bone screw, the method compnsmg: forming an elongated shaft about a core, an enlarged head being integrally formed on an end of the core, the shaft having a longitudinal axis extending between a proximal end and an opposing distal end with a first passageway that extends completely through the shaft along the longitudinal axis, the core being disposed within the first passageway and extending along the longitudinal axis, the shaft being comprised of a radiolucent material that includes one or more radiolucent fibers that radially encircles the core, the core and head being comprised of a radiopaque material, wherein the shaft is formed by: winding the one or more radiolucent fibers having an adhesive thereon about the radiopaque core; or winding a sheet comprised of the one or more radiolucent fibers and an adhesive about the radiopaque core; and forming a helical thread on an exterior surface of the shaft by removing a portion of the exterior surface of the shaft. Appeal Br. 15, 17 (Claims App'x). The following rejections are appealed: 3 Claims 54--56, 60-62, 64, 74, and 76 stand finally rejected under 35 U.S.C. Â§ I03(a) over Dewey, 4 Heinz, 5 and Bhatnagar. 6 Final Action 3.7 3 An obviousness rejection of claim 63 was withdrawn. Answer 12. 4 US 2007/0233071 Al (pub. Oct. 4, 2007) ("Dewey"). 5 US 2008/0154306 Al (pub. June 26, 2008) ("Heinz"). 6 US 2009/0082810 Al (pub. Mar. 26, 2009) ("Bhatnagar"). 7 We note that claim 64 is not listed in the initial paragraph of the Final Office Action introducing this rejection, but the claim is substantively 3 Appeal2017-007159 Application 13/063,605 Claims 58 and 59 stand finally rejected under 35 U.S.C. Â§ I03(a) over Dewey, Heinz, Bhatnagar, and Erickson. 8 Id. at 6. Claims 54 and 65 stand finally rejected under 35 U.S.C. Â§ I03(a) over Dewey, Heinz, and Bhatnagar. Id. at 9. Claims 66 and 77-79 stand finally rejected under 35 U.S.C. Â§ I03(a) over Dewey, Heinz, and Bhatnagar. Id. at 12. DISCUSSION "[T]he examiner bears the initial burden, on review of the prior art or on any other ground, of presenting aprimafacie case ofunpatentability. If that burden is met, the burden of coming forward with evidence or argument shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). A proper Â§ 103 analysis requires "a searching comparison of the claimed invention-including all its limitations-with the teachings of the prior art." In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995). "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398,416 (2007). "[T]he analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418. "What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid underÂ§ 103." Id. at 419. "[R]ejections on obviousness grounds discussed thereafter as rejected. See Final Action 2, 5. Therefore, we treat claim 64 as rejected. 8 US 2007 /0270851 Al (pub. Nov. 22, 2007) ("Erickson"). 4 Appeal2017-007159 Application 13/063,605 cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness." Id. at 418 (quoting In re Kahn, 441 F.3d 977,988(Fed.C~.2006D. The Examiner presented essentially two obviousness rejections, one of which was repeated several times, but for different claims. The Examiner determined that claims 54--56, 60-62, 64--66, 74, and 76-79 would have been obvious over the Dewey-Heinz-Bhatnagar combination and that claims 5 8 and 59 would have been obvious over this same combination, but also adding Erickson, as respectively indicated in the Final Action and Answer. Final Action 2-16 and Answer 2-17 (citing Dewey ,r,r 34, 36, 39--41, 49, Figs. 3, 6, 13, 14, 16; Heinz ,r 23; Bhatnagar ,r,r 124--128, 192, Figs. 5, 6; and Erickson ,r 33). Except as otherwise indicated below, we discern no error in the Examiner's findings of fact, rationale, and determinations of obviousness. We address Appellants' arguments below. Appellants argue the Examiner has not established a valid rationale for combining the teachings of Dewey and Bhatnagar (i.e., that it was well known in the art to assemble composite bone screws using a prefabricated sheet and adhesive whereby the sheet is secured about the core of the implant). Appeal Br. 7 ( citing Final Action 4 ); see also id. at 9 (presenting the same argument for claim 66). This argument is not persuasive. The Examiner responded to this argument by identifying that Bhatnagar discloses that its sheet can be flexibly-adhered ( or applied in several other ways) to a screw (like that disclosed by Dewey). Answer 13-14 (citing Bhatnagar ,r,r 124, 125, 128). 5 Appeal2017-007159 Application 13/063,605 The Examiner's rationale for attaching the disclosed sheet to the screw is that when applying a bone growth promoter to a bone screw, doing so as a pre-fabricated sheet, as disclosed in Bhatnagar (at ,r 124), is an obvious alternative way of doing so. Id. Consistently, Dewey specifically discloses that promoting an increase of bone growth around the bone engaging portion of its screw is desirable. See Dewey ,r 35. Thus, there was ample reason to combine Dewey's screw (particularly its bone interface portion 18, i.e., its shaft) and Bhatnagar's bone growth promoting agent (i.e., a sheet 110). Appellants argue that, even if Dewey and Bhatnagar were combined, doing so "would not produce 'a helical thread recessed into the pre- fabricated sheet encircling the radiopaque core,' as recited in claim 54." Appeal Br. 8; see also id. at 10 (presenting the same argument for claim 66). This argument is not persuasive. Bhatnagar discloses its sheet is flexible and adhered to an underlying screw. Bhatnagar ,r,r 124--128. Further, as identified by the Examiner, Dewey discloses forming threads in a bone interface portion 18 of its screw. Dewey ,r 40. Doing so would produce a helical thread recessed into the bone growth promoting layer of the bone interface portion when the components of Dewey and Bhatnagar were combined, as suggested. The claimed element would have been obvious over the prior art combination. Appellants argue that the prior art combination would not produce predictable results, i.e., there would be no reasonable likelihood of successfully combining the references to achieve the invention of claim 54. Appeal Br. 8-9; see also id. at 10 (presenting the same argument for claim 66). 6 Appeal2017-007159 Application 13/063,605 This argument is not persuasive. Appellants present no persuasive evidence that the field of the invention is unpredictable or that the skilled artisan would not have reasonably expected to successfully combine the familiar elements of the cited prior art according to known methods as disclosed in the cited prior art. For the reasons above, we affirm the rejection of claims 54--56, 58- 62, 64--66, 7 6, 77, and 79 as obvious. Regarding claims 7 4 and 78, Appellants argue the claims recite "wherein the one or more radiolucent fibers radially encircle the core in a helical pattern that extends along a length of the core," that the Examiner points to Dewey Figure 3 as teaching such an element, and that neither Dewey ( at Figure 3 or elsewhere) nor Bhatnagar teaches or suggests such an element. Appeal Br. 11-13. The Examiner responds to this argument stating: As set forth in the rejection of claim 54, above, the combination teaches a shaft comprised of radiolucent fibers, specifically wherein the fibers are presented in the form of carbon fiber reinforced PEEK (see pg. 3 above). The shaft is also threaded in a helical pattern as seen in Dewey fig. 3. Because the shaft is machined to have helical threads radially encircling the core along the length of the core, and the threads themselves are comprised of the radiolucent fibers, one or more of the radiolucent fibers also radially encircle the core in a helical pattern that extends along a length of the core. For these reasons, the combination teaches a bone screw wherein the one or more radiolucent fibers radially encircle the core in a helical pattern that extends along a length of the core, and the rejection of claims 7 4 and 7 8 are proper. Answer 16-17. 7 Appeal2017-007159 Application 13/063,605 To address this rejection and Appellants' argument, we must understand what the respective claims mean by "wherein the one or more radiolucent fibers radially encircle the core in a helical pattern that extends along a length of the core." The plain language of the claim requires the fibers ( or at least a fiber) to encircle the core in a helical pattern. Looking to the Specification, paragraph 97, in describing Figure 14, it refers to "fibers" helically wound around a core. Thus, we interpret the claim element to require at least a fiber to be provided in a helical pattern, similar to that shown in Figure 14. The Examiner's rationale for finding a helical pattern obvious over the combination of Dewey and Bhatnagar does not comport with such a claim interpretation. While providing a sheet patterned in a helical thread over a screw, as would be the case if a sheet as in Bhatnagar were provided over a bone interface portion and then cut with it as disclosed by Dewey, would provide a helical pattern in such a sheet, generally, it is unclear that any fiber would be in such a helical pattern. We, therefore, reverse the obviousness rejection as to claims 74 and 78. NEW GROUND OF REJECTION Claims 74 and 78 are rejected under 35 U.S.C. Â§ 103(a) as obvious over Dewey, Heinz, and Bhatnagar. As further added to below, except as contrary to our discussion below, we adopt and incorporate the respective findings of fact by the Examiner in the Final Action and Answer, noted supra. "If a person of ordinary skill can implement a predictable variation [ of a known work],Â§ 103 likely bars its patentability." KSR, 550 U.S. at 417. 8 Appeal2017-007159 Application 13/063,605 The obviousness analysis "can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418. "A person of ordinary skill is also a person of ordinary creativity, not an automaton." Id. at 421. Although the Examiner cited Bhatnagar as teaching the pre-fabricated sheet as recited by claims 54 and 66, upon which claims 74 and 78 respectively depend, the Examiner pointed to Dewey as teaching the claimed "wherein the one or more radiolucent fibers radially encircle the core in a helical pattern that extends along a length of the core," indicating that such a radial encirclement and helical pattern would be caused by cutting threads into the shaft/sheet. As discussed above, because we interpret the helically patterned fibers to require an arrangement of a fiber, similar to that as illustrated in the Specification at Figure 14 and described at paragraph 97, we find that merely cutting a sheet having fibers into a helix shape will not necessarily result in any fibers being in a helical pattern. However, although not identified by the Examiner, Bhatnagar discloses: In some embodiments, however, a bone growth promoting agent may be applied in particular patterns throughout a portion. Depending on the circumstances, different types of patterns may be used to promote bone growth. Examples of some patterns include stripes, spots, helical or spiral, geometric patterns, or combinations incorporating one or more of these basic pattern elements. The term geometric pattern refers to any polygonal pattern including square (shown in the Figures), rectangular, polygon, honeycomb, repeating, non-repeating, regular, irregular, as well as other types of patterns. A striped pattern includes thin lines of bone growth promoting agent that are disposed along a particular portion. In 9 Appeal2017-007159 Application 13/063,605 this arrangement, there is no bone growth promoting agent between the stripes. A spotted pattern may include small spots of the bone growth promoting agent. In a similar manner, a geometric pattern may include alternating shapes of a bone growth promoting agent. Various patterns may be used depending on the way in which the user wants to induce bone growth along or adjacent to the prosthetic. FIGS. 10-13 illustrate various patterns of bone growth promoting agents applied to rods. Bhatnagar ,r,r 134--136 (emphasis added). Bhatnagar illustrates a helically patterned bone growth promoting agent application at Figure 13, reproduced below: 174 FIG. 13 Bhatnagar's Figure 13 shows in "a preferred embodiment, bone growth promoting agent 174 may be disposed in a spiral or helical pattern along first portion 172. Generally, the thickness and spacing of this spiral pattern may be varied." Id. ,r 139. Bhatnagar, therefore, teaches and suggests that any geometric pattern, including a helix, of bone growth promoting agent, which may take the form of a sheet made of a mesh fabric adhered to a screw, is possible. The 10 Appeal2017-007159 Application 13/063,605 claimed "one or more radiolucent fibers radially encircle the core in a helical pattern that extends along a length of the core," and, therefore, claims 74 and 78, would have been obvious in view of such a disclosure. SUMMARY The obviousness rejections are affirmed as to claims 54--56, 58---62, 64---66, 76, 77, and 79, and reversed as to claims 74 and 78. Claims 74 and 78 are rejected under 35 U.S.C. Â§ 103(a) as obvious over Dewey, Heinz, and Bhatnagar. TIME PERIOD FOR RESPONSE This Decision contains a new ground of rejection pursuant to 37 C.F.R. Â§ 4I.50(b), which provides, "[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review." 37 C.F.R. Â§ 4I.50(b) also provides: When the Board enters such a non-final decision, the appellant, within two months from the date of the decision, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amend- ment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the prosecution will be remanded to the examiner. The new ground of rejection is binding upon the examiner unless an amendment or new Evidence not previously of Record is made which, in the opinion of the examiner, overcomes the new ground of rejection designated in the decision. Should the examiner reject the claims, appellant may again appeal to the Board pursuant to this subpart. (2) Request rehearing. Request that the proceeding be reheard under Â§ 41.52 by the Board upon the same Record. The 11 Appeal2017-007159 Application 13/063,605 request for rehearing must address any new ground of rejection and state with particularity the points believed to have been misapprehended or overlooked in entering the new ground of rejection and also state all other grounds upon which rehearing is sought. Further guidance on responding to a new ground of rejection can be found in the Manual of Patent Examining ProcedureÂ§ 1214.01. AFFIRMED-IN-PART 37 C.F.R. Â§ 4I.50(b) 12