DETAILED ACTION
The following is a final office action is response to communications received on 09/24/2025. Claims 20-39 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 .
Response to Arguments
Applicant's arguments filed 09/24/2025 have been fully considered but they are not persuasive. Applicant argues that the rejection is moot as original claims 1-19 are cancelled, and that new claims 20-39 are not anticipated by McKay (US 9,364,583).
The examiner respectfully disagrees. A new ground(s) of rejection is made infra in view of McKay (US 9,364,583) addressing all of the claim limitations as necessitated by amendment.
Claim Objections
Claim 36 is objected to because of the following informalities: Claim is missing a period (punctuation). Appropriate correction is required.
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 20-31 & 35-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,241,317. 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 Claim 20, patent claims 1, 11, 18 & 19 recite the same limitations.
Regarding Claim 21, patent claim 18 recites the same limitations.
Regarding Claims 22-26, patent claims 2-6 recite the same limitations.
Regarding Claims 27-30, patent claims 12-15 recite the same limitations.
Regarding Claim 31, patent claim 19 recites the same limitations.
Regarding Claims 35-38, patent claims 7-10 recite the same limitations.
Regarding Claim 39, patent claim 21 recites the same limitations.
Claims 1-3, 6-8 & 11-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,121,440. 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 20, 21, 27, 29, 31, 35, 37 & 38, patent claims 1 & 2 recite the same limitations.
Regarding Claim 28, patent claim 3 recites the same limitations.
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.
Claim(s) 20-31 & 35-39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McKay (US 9,364,583).
Regarding Claim 20, McKay teaches a method of preparing an implantable bone graft device, the method comprising:
providing an open-ended (Col 22:lines 37-47) bioresorbable casing (112) comprising a cavity (114) for receiving and containing a fill material (Fig 2) and a surface having both micropores and macropores (Col 9: lines 5-8), wherein the macropores are created in a sheet of bioresorbable material by mechanical (Col 15: lines 14-17 and Col 19: lines 20-34), chemical, or thermal process and patterned (Col 15: Lines 5-16 teaches a mesh, which would be patterned) and sized to prevent the fill material within the cavity from escaping therethrough (Col 14: lines 16-27 teaches fill fibers with a size incapable of passing through the pore size taught) while allowing osteogenic cells to pass through (Col 13: lines 45-47); and
filling the open-ended bioresorbable casing with a fill material (Col 22: lines 37-47).
Regarding Claim 21, McKay teaches wherein the fill material comprises one or more of the group consisting of demineralized bone matrix (DBM) and bioceramics (Col 13: lines 40-45).
Regarding Claim 22, McKay teaches wherein the bioresorbable casing comprises collagen (Col 15: lines 5-16).
Regarding Claim 23, McKay teaches wherein the collagen casing contains demineralized bone matrix (DBM) in one or more formats selected from the group consisting of fibers, granules, paste, powder, chips, strips, and sponge (Col 13: lines 56-63).
Regarding Claim 24, McKay teaches wherein the DBM is processed from one or more of the group consisting of cortical and cancellous bone (Col 9: lines 21-24).
Regarding Claim 25, McKay teaches wherein the collagen casing contains bioceramics (Col 17: lines 13-27; Col 7: lines 37-38) in one or more formats selected from the group consisting of fibers, granules, paste, powder, chips, strips, and sponge.
Regarding Claim 26, McKay teaches wherein the collagen casing contains demineralized bone matrix (DBM) (Col 9: lines 21-24) and bioceramics (Col 17: lines 13-27; Col 7: lines 37-38).
Regarding Claim 27, McKay teaches wherein the bioresorbable casing is formed by one or more strips of collagen (Col 15: lines 5-16) joined together with sutures (Col 22: lines 42-44).
Regarding Claim 28, McKay teaches wherein the sutures comprise a bioabsorbable material selected from the group consisting of polyglycolic acid, polylactic acid, and poly(lactic-co- glycolic acid).
Regarding Claim 29, McKay teaches wherein the bioresorbable casing is formed from a single strip of folded collagen (Fig 4).
Regarding Claim 30, McKay teaches wherein the bioresorbable casing is molded in a single piece (Fig 4).
Regarding Claim 31, McKay teaches wherein the method further comprises: implanting the implantable bone graft device at a target site; and closing the open end of the filled bioresorbable casing, wherein closing comprises suturing the open end of the filled bioresorbable casing (Col 22: lines 42-44).
Regarding Claim 35, McKay teaches wherein the micropores are random (Col 16: line 64-Col 17: line 12 teaches several random natural materials).
Regarding Claim 36, McKay teaches wherein the macropores are generated through molding (Col 17: lines 36-44).
Regarding Claim 37, McKay teaches wherein the macropores are generated through mechanical or thermal techniques (Col 15: lines 14-17 and Col 19: lines 20-34).
Regarding Claim 38, McKay teaches wherein the bioresorbable casing is closed (Col 22: lines 37-47).
Regarding Claim 39, McKay teaches wherein the device is sized and configured for placement in an anatomical structure of a spine (Col 21: lines 31-47).
Allowable Subject Matter
Claims 32-34 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN A DUKERT/Primary Examiner, Art Unit 3774