DETAILED ACTION
Specification
The abstract of the disclosure is objected to because it contains legal phraseology such as “such as” in lines 3-4, lines 11-12 and “comprise” in line 6. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 7-8 are objected to because of the following informalities:
Claim 7 recites in part” wherein said base tissue graft comprises human tissue.” In line 1 should be “wherein said base tissue graft is configured to comprise human tissue.”
Claim 8 recites in part” wherein said human tissue comprise soft, none-bone tissue.” In line 1 should be “wherein said human tissue is configured to comprise soft, none-bone tissue.” Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 AlA. 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 1,4-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,4,6-10,12-13 of U.S. Patent No. 12,496,179 (Amended allowable claims on 8/19/2025) in view of Hunter et al et al U.S 2005/0175703.
Here, claim 1 of U.S Pat 12,496,179, recites
Claim 1 of U.S Pat 12,496,179 (not published yet)
A multi-layer, medicated, reconstructive tissue graft comprising: a base tissue graft having a top surface and a bottom surface, said base tissue graft modified by compressing, cutting and/or removing one or more portions of either or both said top surface and said bottom surface to create one or more designed surface features; a second graft layer or sheet applied to either or both said top surface and said bottom surface of said base tissue graft; and one or more medicants associated with said multi-layer reconstructive graft.
Claim 1 of U.S Pat’179 differs from pending claim 1 in that it fails to disclose “a second graft layer or sheet sprayed onto either or both said top surface and said bottom surface of said base tissue graft”. Hunter et al teach that the tissue cavity or surgical pocket into which a device or implant is placed can be treated with an anti-infective and/or fibrosis-inhibiting therapeutic agent prior to, during, or after the procedure. This can be accomplished in several ways including: (a) topical application of the agent into the anatomical space or surface where the device will be placed (particularly useful for this embodiment is the use of polymeric carriers which release the agent over a period ranging from several hours to several weeks. Compositions that can be used for this application include, e.g., fluids, microspheres, pastes, gels, microparticulates, sprays, aerosols, solid implants and other formulations which release a therapeutic agent into the region where the device or implant will be implanted); (b) microparticulate forms of the therapeutic agent are also useful for directed delivery into the implantation site; (c) sprayable collagen-containing formulations such as COSTASIS and crosslinked derivatized poly(ethylene glycol)-collagen(see paragraph 418); the present invention, therapeutic compositions of anti-infective and/or fibrosis-inhibiting agents may be fashioned in the form of microspheres, microparticles and/or nanoparticles having any size ranging from 50 nm to 500 .mu.m, depending upon the particular use. These compositions can be. These compositions can be formed by spray-drying methods, milling methods, coacervation methods, W/O emulsion methods, W/O/W emulsion methods, and solvent evaporation methods. In other aspects, these compositions can include microemulsions, emulsions, liposomes and micelles. Alternatively, such compositions may also be readily applied as a "spray", which solidifies into a film or coating for use as a device/implant surface coating or to line the tissues of the implantation site.(see paragraph 434). Therefore, it would have been obvious to modify the apparatus of claim 1 U.S Pat’179 with the teaching of spraying a therapeutic agent to the tissue graft as taught by Hunter et al in order to release a therapeutic agent into the region of the implanted device.
As to claims 4-11 are not patentably distinct from each other because they are essentially the same to claims 4,6-10,12-13.
Claim Rejections - 35 USC § 102
(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 Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Bates et al U.S 2008/0181950.
Claim 1: Bates et al disclose a multi-layer, medicated, reconstructive tissue graft (see paragraphs 48,49) comprising: a base tissue graft 39, see paragraph 55 having a top surface and a bottom surface (see fig. 3), said base tissue graft modified by compressing, cutting (see paragraph 124) and/or removing one or more portions of either or both said top surface and said bottom surface to create one or more designed surface features (see paragraphs 62, 66); a second graft layer or sheet (36 spray layer) sprayed onto either or both said top surface and said bottom surface of said base tissue graft (see paragraph 105). Note that the term "bioremodelable" refers to a natural or synthetic material capable of inducing tissue remodeling in a subject or host. A bioremodelable material can include at least one bioactive agent (e.g., growth factor, etc.) capable of inducing tissue remodeling. The ability to induce tissue remodeling may be ascribed to one or more bioactive agents in a bioremodelable material stimulating the infiltration of native cells into an a cellular matrix, stimulating new blood vessel formation (capillaries) growing into the matrix to nourish the infiltrating cells (angiogenesis), and/or effecting the degradation and/or replacement of the bioremodelable material by endogenous tissue. The bioremodelable material may include extracellular collagen matrix (ECM) material, including but not limited to submucosal tissue, such as small intestine submucosal (SIS) tissue or it may include other natural tissue source materials, or other natural or synthetic materials, including one or more bioactive substances capable of inducing tissue remodeling (see paragraph 33). Alternatively, it would have been obvious that the above description of Bates et al device show that one or more medicants (i.e., growth factor is part of medicants as applicant stated in claim 9 “said one or more medicants comprise at least one of … a growth factor) associated with said multi-layer reconstructive graft (see paragraph33). Thus, claim 1 is unpatentable over Bates et al.
Further, it is noted that, the claimed phrase “the base tissue graft being made by compressing, cutting or removing, or the second graft layer being sprayed on “ is product by process (see MPEP 2113, the steps do not hold any weight on the device claim.)
Claims 2-3: Bates et al disclose wherein said one or more medicants are also sprayed onto either or both said top surface and said bottom surface of said base tissue graft., wherein said one or more medicants are sprayed onto said base tissue graft before said second graft layer or sheet is sprayed onto said base tissue graft, whereby said second graft layer is located over said one or more medicants (see paragraphs 33, 105).
Claims 4-6: Bates et al disclose wherein said second graft layer or sheet comprises amnion membrane material (see paragraph 85)., wherein said one or more medicants are injected or inserted into said base tissue graft through said second graft layer or sheet (see paragraph 105)., wherein said one or more medicants are injected using a needle (an infusion needle, see paragraph 199) which is passed through said second graft layer or sheet.
Claims 7-9: Bates et al disclose wherein said base tissue graft comprises human tissue (see paragraph 84)., wherein said human tissue comprises soft, non-bone tissue (see paragraphs 48,49)., wherein said one or more medicants comprise at least one of: an antibiotic, a hormone, a growth factor (see paragraph 33), and a chemo-therapeutic agent.
Allowable Subject Matter
Claims 10-11 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
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/VI X NGUYEN/Primary Examiner, Art Unit 3771