DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 12, 2025, has been entered.
Claims 1-18, 20, 24-26, 34, 35, and 37 are cancelled.
Claims 19, 21, 23, 27-33, 36, and 38 are pending and examined on the merits.
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.
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Claims 19, 21, 23, 27, 28, and 38 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,090,411 in light of Thitiset (International Journal of Molecular Sciences. 2013. 14: 2056-2071. Previously cited).
Although the claims at issue are not identical, they are not patentably distinct from each other because the method of claim 1 of `411 sets forth the claimed composition since claim 1 of `411 recites an osteoinductive implant containing demineralized bone matrix (DBM) fibers, wherein the osteoinductive implant is formed without a carrier. Since the osteoinductive implant is formed without a carrier, then the DBM fibers, directed to the claimed ‘demineralized bone fibers,’ are free from a carrier. Additionally, claim 1 of `411 recites that the osteoinductive implant is exposed to electron beam radiation at a dose of from about 10 kilograys to 100 kilograys for a period of time to reduce microorganisms in the osteoinductive implant, wherein the electron beam irradiated osteoinductive implant retains at least about 80% of its osteoinductive properties (meets the claimed limitation of ‘reduced osteoinductive properties by 0% to 20%’). Claim 7 of `411 recites the limitation of the electron beam irradiation reducing microorganisms to a sterility assurance level (SAL) of about 10-6. It would have been prima facie obvious to apply the limitation of claim 7 of `411 to independent claim 1 of `411 and its dependent claims. Thus, the osteoinductive implant recited in the claims of `411 incorporating claim 7 of `411 is directed to the irradiated osteoinductive implant of instant claim 19. Though claim 1 of `411 recites the additional limitation that the electron irradiated osteoinductive implant contains dry DBM fibers having a length from about 1 to about 70 micrometers, it is directed to a narrower scope that is wholly encompassed by the claimed osteoinductive implant. As such, claim 7 of `411 as well as claim 1 of `411 incorporating claim 7 of `411, each renders obvious instant claim 19.
Regarding instant claim 21, claim 2 of `411 recites the claimed limitation. Thus, claim 2 of `411 incorporating claim 7 of `411 renders obvious instant claim 21.
Regarding instant claim 23, claim 8 of `411 recites the claimed limitation. Thus, claim 8 of `411 incorporating claim 7 of `411 renders obvious instant claim 23.
Regarding instant claim 27, as evidenced by Thitiset, demineralized bone powder (DBP), prepared by acid extraction of allograft bone, retains collagen (page 2057, first paragraph). Therefore, the demineralized bone matrix fibers of the claims of `411 inherently comprise collagen. As such, instant claim 27 is rendered obvious by each of claim 7 of `411 and claim 1 of `411 incorporating claim 7 of `411 (in light of Thitiset, cited as evidence).
Regarding instant claim 28, as evidenced by Thitiset, demineralized bone powder (DBP) comprises bone morphogenetic proteins (page 2057, first paragraph). Therefore, the demineralized bone matrix fibers of the claims of `411 inherently contain bone morphogenetic protein. As such, instant claim 28 is rendered obvious by each of claim 7 of `411 and claim 1 of `411 incorporating claim 7 of `411 (in light of Thitiset, cited as evidence).
Regarding instant claim 38, it is directed to an intended use. Claim 11 of `411 recites that the osteoinductive implant is molded to conform to a bone cavity after it is hydrated. Since the osteoinductive implant can be molded after hydration, then the osteoinductive implant is suitable for being configured to be placed into a syringe for delivery to a patient as claimed. Thus claim 11 of `411 incorporating claim 7 of `411 renders obvious instant claim 38.
Claims 29, 30, 32, 33, and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,090,411 in view of Dowd (US 5,507,813. Previously cited).
As discussed above, the claims of `411 (in light of Thitiset, cited as evidence) render obvious claims 19, 21, 23, 27, 28, and 38. However, the claims of `411 differ from instant claim 29 in that they do not recite that the demineralized bone fibers comprise cortical bone. The claims of `411 differ from instant claim 30 in that they do not recite that the demineralized bone fibers are ribbon shaped. The claims of `411 differ from instant claim 32 in that they do not recite that the demineralized bone fibers comprise cancellous bone. The claims of `411 differ from instant claim 33 in that they do not recite that the demineralized bone fibers comprise <10%, <5% or <1% by weight residual calcium content. The claims of `411 differ from instant claim 36 in that they do not recite that the osteoinductive implant contains an antimicrobial agent.
Dowd discloses surgically implantable shaped materials comprising a coherent mass of elongate, mechanically entangled demineralized bone particles (claim 1 of Dowd; abstract). When applied to a site of a bone defect, it leads to new bone ingrowth which can be by osteoinduction (column 2, lines 1-5). Thus the surgically implantable shaped material of Dowd is directed to an ‘osteoinductive implant’ as claimed. The elongate bone particles can be described as fibers (column 3, lines 13-15). Therefore, the surgically implantable shaped material of Dowd comprises demineralized bone fibers.
Dowd teaches that the bone particles can be obtained from cortical or cancellous bone (column 3, lines 18-20). Dowd teaches that the elongate bone particles can be described as fibers, and slender or narrow strips (column 3, lines 13-16). Also, Dowd teaches that when the elongated bone particles are subjected to demineralization, it can be performed to reduce their inorganic content to a low level such as not more than about 5% by weight of residual calcium, and preferably not more than about 0.5% by weight residual calcium (column 3, lines 26-31). Dowd teaches that any of a variety of medically and/or surgically useful substances can be incorporated in, or associated with, the bone particles (column 4, lines 18-21). The medically/surgically useful substances which can be readily combined with the demineralized bone particles include antimicrobials (column 4, lines 26-32).
It would have been obvious to apply the teachings of Dowd regarding their surgically implantable shape materials to the invention of the claims of `411, specifically with respect to the type of bone used for the demineralized bone matrix fibers (cortical or cancellous bone), the shape of the demineralized bone matrix fibers (slender or narrow strips which are directed to ‘ribbon shaped’), the residual calcium content of the demineralized bone matrix fibers, and the inclusion of antimicrobials. Since the teachings of Dowd are directed to demineralized bone particles that can be described as fibers and are used in a surgically implantable material for implantation, then the skilled artisan would have recognized their teachings regarding demineralized bone particles would be suitable for the demineralized bone matrix fibers of the osteoinductive implant of the claims of `411. Additionally, one of ordinary skill in the art would have been motivated to include an antimicrobial in the osteoinductive implant of the claims of `411 since it is a medically/surgically useful substance and was found to be suitable for inclusion in a surgically implantable material comprising demineralized bone fibers. Thus the claims of `411 (claim 7 of `411, and each of the other claims of `411 incorporating claim 7 of `411) in view of Dowd render obvious instant claims 29, 30, 32, 33, and 36.
Response to Arguments
Applicant’s arguments, filed September 12, 2025, with respect to the rejection under 35 U.S.C. 112(b) of claims 19, 21-23, 27-33, 36, and 38, the rejection under 35 U.S.C. 102(a)(1) and 102(a)(2) of claims 19, 21, 23, 27-33, 36, and 38 as being anticipated by Dowd in light of Thitiset, the rejection under 35 U.S.C. 103 of claim 22 as being obvious over Dowd in light of Thitiset, the nonstatutory double patenting rejection of claims 19, 21, 23, 27, 28, 31, and 38 as being unpatentable over claims 1-15 of U.S. Patent No. 9,999,520 in view of Thitiset, and the nonstatutory double patenting rejection of claims 29, 30, 32, 33, and 36 as being unpatentable over claims 1-15 of U.S. Patent No. 9,999,520 in view of Thitiset and further in view of Dowd, have been fully considered and are persuasive.
In particular, the rejection under 35 U.S.C. 112(b) has been overcome by the amendment to claim 19. The rejections under 35 U.S.C. 102 and 103 over Dowd (in light of Thitiset) have been overcome by the arguments concerning the evidence of Kim (Biomaterials Research. 2015. 19:10. Listed on IDS filed 9/12/25) on page 5, first and second paragraphs of the Remarks filed September 12, 2025. In particular, the teachings regarding the effects of electron beam irradiation (EBI) on bony material in the paragraph bridging pages 8 and 9 of Kim are persuasive in demonstrating that the claimed electron beam irradiation would have been expected to confer properties on demineralized bone fibers that distinguish it from the demineralized bone fibers of Dowd disinfected by an aqueous ethanol solution. Additionally, the nonstatutory double patenting rejections over the claims of U.S. Patent No. 9,999,520 have been overcome by the amendment to claim 19 since the claims of `520 do not recite an electron beam-irradiated osteoinductive implant having reduced microorganisms to a sterility assurance level (SAL) of about 10-6, and that limitation is not obvious over the claims of `520.
Therefore, these rejections have been withdrawn.
However, Applicant’s arguments are unpersuasive with respect to the nonstatutory double patenting rejections over the claims of U.S. Patent No. 11,090,411. Applicant asserts that said Restriction Requirement classified the current claims in A61L 27/3608 which is patentably distinct from the claims in the `411 patent classified under a different classification. However, this does not signify that a nonstatutory double patenting rejection cannot be made over the claims of `411, nor is there a prohibition against a double patenting rejection under 35 U.S.C. 121 over the `411 patent since the instant application is not a divisional application of U.S. Patent Application No. 15/008,676. Applicant notes that the division has a proper priority claim and is indeed based on the parent application 15/008,676. However, the nonstatutory double patenting rejection is not based on whether there is a proper priority claim to parent application 15/008,676. While the instant application is a child of the parent application 15/008,676, this does not signify that the instant application is a divisional application of 15/008,676.
Conclusion
Claims 19, 21, 23, 27-30, 32, 33, 36, and 38 are not allowed.
Claim 31 is 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.
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/SUSAN E. FERNANDEZ/Examiner, Art Unit 1651