DETAILED ACTION
The following is a non-final office action is response to communications received on 11/21/2023. Claims 1-19 are currently pending and addressed below.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 7 & 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 11,857,419. The elements of the instant application are to be found in the Patent and therefore are anticipated. Although the conflicting claims are not identical, they are not patentably distinct from each other because the Patent and the instant application all recite the same basic structure with a permutation of similar elements throughout.
Regarding Claims 1, 7 & 9, patent claim 15 recites the same limitations.
Claims 1, 4 & 7-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 10 & 14 of U.S. Patent No. 11,857,419 in view of Verlaan et al. (US 2021/0177466).
Regarding Claims 1 & 7, US 11,857,419 discloses the invention substantially as claimed. However, US 11,857,419 does not specifically disclose wherein the system comprises a bone fastener comprising a head and a shank extending from the head. Verlaan teaches a bone fastener (20) comprising a head and a shank extending from the head (Fig 4) configured to retain a graft collar (1). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize the bone fastener, as taught by Verlaan, in order to retain the graft collar of US 11,857,419 while anchoring to underlying bone.
Regarding Claim 4, patent claim 9 recites the same limitations.
Regarding Claim 8, patent claim 10 recites the same limitations.
Regarding Claims 9-12, patent claim 14 recites the same limitations.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 & 13 state “wherein the graft collar is a non-load bearing structure” in lines 8 and 4 respectively. It is unclear how the claimed graft collar can be reasonably considered to be non-load bearing. In fact, several of the dependent claims contain limitations directed towards the graft collar bearing at least some load. For example, claim 4 requires that the graft collar is threaded to engage the threaded shank (a load) of the fastener. Claim 5 states wherein the graft collar is secured (a load) on the fastener. Claims 8 & 14 require that the graft collar exhibits a first shape at rest and a second shape when compressed between the bone fastener ana biological structure (a load). All of these dependent claims reasonably place the graft collar under some amount of load. The specification provides no further guidance on how the graft collar could be interpreted as non-load bearing. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5, & 6 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Verlaan et al. (US 2021/0177466).
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Regarding Claim 1, as best understood (see 112 rejection supra), Verlaan teaches a system (Fig 4), comprising: a graft collar (1) including a body having an upper surface (shown) and a spaced apart lower surface (shown) defining an outer wall (shown) and surface therebetween, a substantially planer engagement section (shown) on the lower surface to engage a bone surface (52); and a through hole (3) extending axially through the body between the upper surface and the lower surface thereof, and a bone fastener (20) including a head (24) and a shank (21) extending from the head, wherein: the through hole of the graft collar being sized to receive the shank from the bone fastener (Fig 4), the graft collar is a non-load-bearing structure, and the bone fastener is a load-bearing structure (threaded into bone 51).
Regarding Claim 2, Verlaan teaches wherein the shank (21) of the bone fastener includes a threaded portion (22) for engagement with bone tissue (Fig 4).
Regarding Claim 5, Verlaan teaches wherein a non-threaded portion (shown) of the shank (21) of the bone fastener is located between the head and the threaded portion of the shank; and the graft collar is secured on the non-threaded portion of the shank (Fig 4).
Regarding Claim 6, Verlaan teaches wherein the non-threaded portion of the shank of the bone fastener is tapered (Fig 4).
Claim(s) 1 & 7-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Neill et al. (US 9,044,277).
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Regarding Claim 1, as best understood (see 112 rejection supra), O’Neill teaches a system (10), comprising: a graft collar (12) including a body having an upper surface (shown) and a spaced apart lower surface (shown) defining an outer wall (shown) and surface therebetween, a substantially planer engagement section (shown) on the lower surface to engage a bone surface; and a through hole (32) extending axially through the body between the upper surface and the lower surface thereof, and a bone fastener (14) including a head (20) and a shank (22) extending from the head, wherein: the through hole of the graft collar being sized to receive the shank from the bone fastener (Fig 2A), the graft collar is a non-load-bearing structure, and the bone fastener is a load-bearing structure (threaded into bone).
Regarding Claims 7 & 15, O’Neill teaches wherein the graft collar (12) includes graft material having one or more of: hard allograft (Col 11: lines 56-60), soft allograft, and synthetic bone void fillers.
Regarding Claims 8 & 14, O’Neill teaches wherein the graft collar exhibits a first shape at rest (Fig 2A) and a second shape when compressed between the head of the bone fastener (14) and a biological structure of a patient into which the system is implanted. The device of O’Neill is fully capable of having a second shape when compressed. As O’Neill meets all the structural limitations of the claim(s) 1, 7, 8 & 14, O’Neill anticipates the functional language recited herein. The functional language does not further limit the claim because the structure (i.e., material and orientation) that accomplishes the function is recited by O’Neill.
Regarding Claims 9 & 16, O’Neill teaches wherein the graft material provides for wicking of liquid biologics. The device of O’Neill is fully capable of wicking liquid biologics. As O’Neill meets all the structural limitations of the claim(s) 1, 7, 9 & 16, O’Neill anticipates the functional language recited herein. The functional language does not further limit the claim because the structure (i.e., material and orientation) that accomplishes the function (i.e., wicking) is recited by O’Neill.
Regarding Claim 10, O’Neill teaches wherein the graft collar exhibits a first shape (Fig 2A) prior to the wicking of liquid biologics, and acquires a second shape following absorption of the liquid biologics. As O’Neill meets all the structural limitations of the claim(s) 1, 7, 9 & 10, O’Neill anticipates the functional language recited herein. The functional language does not further limit the claim because the structure (i.e., material and orientation) that accomplishes the function (i.e., wicking) is recited by O’Neill.
Regarding Claim 11, O’Neill teaches wherein the liquid biologics includes at least one of blood and cells of a patient into which the system is implanted. As O’Neill meets all the structural limitations of the claim(s) 1, 7, 9 & 11, O’Neill anticipates the functional language recited herein. The functional language does not further limit the claim because the structure (i.e., material and orientation) that accomplishes the function (i.e., wicking) is recited by O’Neill.
Regarding Claim 12, O’Neill teaches wherein the liquid biologics are absorbed after the bone fastener and graft collar have been implanted into the patient. As O’Neill meets all the structural limitations of the claim(s) 1, 7, 9, 11 & 12, O’Neill anticipates the functional language recited herein. The functional language does not further limit the claim because the structure (i.e., material and orientation) that accomplishes the function (i.e., wicking) is recited by O’Neill.
Regarding Claim 13, O’Neill teaches the method of implanting the system of rejected claim 1. Further O’Neill teaches wherein the graft material is an annular shape (Fig 2A).
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hayeck et al. (US 7,229,445).
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Regarding Claim 1, as best understood (see 112 rejection supra), Hayeck teaches a system (Fig 3), comprising: a graft collar (10) including a body having an upper surface (shown) and a spaced apart lower surface (shown) defining an outer wall (shown) and surface therebetween, a substantially planer engagement section on the lower surface (shown) to engage a bone surface; and a through hole (30) extending axially through the body between the upper surface and the lower surface thereof (Fig 3), and a bone fastener (100) including a head (102) and a shank (104) extending from the head, wherein: the through hole of the graft collar being sized to receive the shank from the bone fastener (Fig 3), the graft collar is a non-load-bearing structure, and the bone fastener is a load-bearing structure (threaded to the bone).
Regarding Claim 2, Hayeck teaches wherein the shank of the bone fastener includes a threaded portion for engagement with bone tissue (Figs 3 & 15).
Regarding Claim 3, Hayeck teaches wherein the threaded portion of the shank is adjacent to the head of the bone fastener and extends the length of the shank (Fig 15), and graft collar is secured adjacent to the head of the bone fastener (Fig 1).
Regarding Claim 4, Hayeck teaches wherein the through hole of the graft collar (10) is threaded (Fig 3) to engage the threaded shank of the load-bearing bone fastener (Fig 15).
Allowable Subject Matter
Claims 17-19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN AINSLEY DUKERT whose telephone number is (571)270-3258. The examiner can normally be reached Mon-Fri 6am-4pm.
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/BRIAN A DUKERT/Primary Examiner, Art Unit 3774