DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendments
Applicant's amendments filed 7/02/2026 to claims 14, have been entered. Claims 1-13 are 21 are canceled. Claims 14-20 and 22-31 remain pending, of which claims 20 and 22-31 are being considered on their merits. Claims 14-19 remain withdrawn from consideration. References not included with this Office action can be found in a prior action. Any rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 20 and 22-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
See MPEP § 2163(I)(B), 2163.06, and 2163.07 for a more detailed discussion of the written description requirement and its relationship to new matter. The proscription against the introduction of new matter in a patent application (35 U.S.C. 132 and 251) serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981).
In this case, claim 20 recites “the opposite second exposed surface of the allograft dermal tissue form comprises from 90% to 10% reticular dermis from the donor skin tissue and from 10% to 90% adipose tissue-from the hypodermis of the donor skin tissue, and lacks other component layers of skin.”, which lacks original support. The claimed percentage ranges of reticular dermis and adipose tissue do not appear to be found in the original disclosure, as there does not appear to be support for the amendments in the specification, the drawings, nor the original claims filed 2/23/2024.
Applicant must either specifically point out the original descriptive support for the full scope of claim 20 to obviate the new matter rejection necessitated by Applicant’s amendment to claim 20, or amend claim 20 accordingly in the next reply to remove the new matter as set forth above.
In so much that claims 22-31 depend from claim 20, these claims must incorporate the new matter of claim 20 and so must be rejected under 35 U.S.C. § 112(a) for new matter.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 20 and 23-26 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Livesey et al. (US 8,067,149; provided in the IDS submitted on 4/22/2025) in view of Krejci et al. (J Invest Dermatol 97:843-848, 1991; Reference U) and Rosson et al. (US 2011/0183001).
Livesey teaches an acellular reticular dermal matrix and methods of making thereof, the method comprising: 1) providing a donor skin tissue harvested from human or porcine sources with a dermatome (Example 1 at Col. 21, lines 52-60), 2) placing said donor skin tissue reticular side-down in a de-epidermizing solution comprising 1M NaCl (Example 1 at Col. 22, lines 5-23), 3) removing the epidermis as an intact sheet with forceps (Example 1 at Col 22, lines 16-19), 4) peeling away the epidermis and cutting the remaining dermis to identify the upper and lower dermal surfaces (Example 1 at Col. 22, lines 20-23), 5) rinsing the dermis with sterile wash solution (Example 1 at Col. 22, lines 24-31), 6) contacting the dermis with decellularization solution followed by additional washing (Example 1 at Col. 22, lines 32-54), 7) cutting the treated dermis into sheets/strips with 0.5-1 cm wide and 1 cm long (Example 1 at Col. 22, lines 55-64), and then packaging said treated dermis (Example 1 at Col 22, lines 65-67), reading in-part on claim 20 and on the composition lacking an epidermis of claim 20. Livesey teaches that the acellular reticular dermal matrix contains intact (extracellular matrix) (Example 1 at Col. 23, lines 43-48), reading in-part on claim 20. Livesey teaches an embodiment comprising the processed dermis and meshed graft (Col. 24, line 60-67), reading on claims 23 and 24. Livesey teaches an embodiment of reconstituting the acellular dermal matrix with cells such as keratinocytes (Col. 6, lines 39-49), reading on claim 25 and the embodiment of keratinocytes for claim 26. Livesey teaches a need in this art to improve methods of making acellular allogeneic tissue matrices, as there is limited supplies of autologous tissues and there are known deficiencies with man-made/synthetic materials when implanted into subjects as prosthetic heart valves, and fresh allogeneic skin is typically rejected by the host even with the use of immunosuppressive drugs (Col. 2, line 46 through Col. 4, line 2), reading on claim 20.
Regarding claim 20, Livesey is silent if the remaining dermis lacks a papillary dermis, papillary-reticular dermis interface, and a portion of the papillary-reticular dermis interface and reticular dermis and is in bilayer form. Regarding claim 20, Livesey is silent regarding any adipose tissue present in the acellular reticular dermal matrix bilayer composition. Regarding claim 20, Livesey does not teach any particular ratio of reticular dermis-to-adipose tissue from the donor skin tissue.
Krejci teaches a composition consisting of reticular dermis obtained from donor skin tissue and prepared by cutting with a dermatome twice and wherein the epidermis and basement membrane are removed (also referred to as second cut dermis or SCD) (p843-844, subheading “Dermal Preparations), reading on claim 6. Krejci teaches that a composition consisting of reticular dermis and fibroblasts is a good substrate for keratinocyte growth, and differentiation (Abstract), reading on claim 20.
Rosson teaches a composition comprising acellular biomaterial made from subcutaneous adipose tissue (Abstract and ¶0004). Rosson teaches that the acellular biomaterial made from subcutaneous adipose tissue (e.g. obtained from lipoaspirate) contains an intact extracellular matrix (i.e. ECM) (Example 3), reading on claim 20. teaches that the acellular biomaterial made from subcutaneous adipose tissue integrates into surrounding host tissue with minimal inflammation (Example 6), reading on claim 20
Regarding claim 20, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further remove the basement membrane from the reticular dermis composition of Livesey in view Krejci. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Krejci and Livesey are directed towards reticular dermis compositions. The skilled artisan would have been motivated to do so because Krejci teaches that a composition consisting of reticular dermis and fibroblasts is a good substrate for keratinocyte growth, and differentiation, and so the modification would predictably improve upon the reticular dermis composition of Livesey.
Regarding claim 20, it would have been obvious to a person of ordinary skill in the art before the invention was filed to add the acellular biomaterial made from subcutaneous adipose tissue of Rosson to the acellular reticular dermal matrix of Livesey. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Rosson and Livesey are directed towards acellular extracellular matrix compositions made from tissue. The skilled artisan would have been motivated to do so because Rosson teaches that the acellular biomaterial made from subcutaneous adipose tissue integrates into surrounding host tissue with minimal inflammation when administered to subject(s), so the addition would predictably improve upon the composition of Livesey to elicit minimal inflammation when administered to a subject.
Regarding the ratio of reticular dermis-to-adipose tissue from the donor skin tissue of claim 20, optimization within prior art conditions or through routine experimentation will generally not support patentability absent a showing of criticality of the claimed range to the contrary. See M.P.E.P. § 2144.05, particularly subsections II and III. In this case, the preponderance of evidence makes clear that adding Rosson’s adipose tissue to Livesey reticular dermis composition would be predictably advantageous to elicit minimal inflammation when administered to a subject, and so any particular ratio of reticular dermis to adipose tissue in Livesey’s reticular dermal composition in view of Rosson would be optimization within prior art conditions or through routine experimentation. Thus, the burden is shifted back to establish criticality of the claimed ratio of reticular dermis-to-adipose tissue by objective evidence.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 22 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Livesey, Krejci, and Rosson as applied to claim 20 above, and further in view of Griffey et al. (US 7,358,284; provided in the IDS dated 4/22/2025).
The teachings of Livesey, Krejci, Rosson are relied upon as set forth above.
Regarding claim 22, Livesey, Krejci, and Rosson do not teach a particulate formulation of the allograft dermal tissue.
Griffey teaches methods of processing an acellular tissue matrix into a particulate acellular tissue matrix (Abstract), reading on claim 22. Griffey teaches that a particulate formulation is advantageous for injection and would extend the beneficial properties of acellular dermal matrices such as AlloDerm® to new applications (Col. 2, lines 13-18) and that the injected particulate matrix repopulates with the subject’s endogenous cells and without any severe acute inflammatory response (Col. 9, lines 6-24), reading on claim 9. Griffey teaches forming the particulate acellular dermal matrix in-part by cryofracturing (Col. 8, lines 26-63), reading on claim 22.
It would have been obvious before the invention was made to further process the acellular dermal matrix of Livesey into a particulate formulation according to Griffey. A person of ordinary skill in the art would have had a reasonable expectation of success in doing so because both Livesey and Griffey are directed towards acellular dermal matrix compositions, and because Griffey teaches detailed methods of cryofracturing the acellular dermal matrix to generate the particulate formulation. The skilled artisan would have been motivated to do so because Griffey teaches that a particulate formulation is advantageous for injection and would extend the beneficial properties of acellular dermal matrices such as AlloDerm® to new applications and that the injected particulate matrix repopulates with the subject’s endogenous cells and without any severe acute inflammatory response.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made.
Claims 27-30 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Livesey, Krejci, and Rosson as applied to claim 20 above, and further in view of Rosenberg et al. (US 7,582,309; provided in the IDS submitted on 4/22/2025).
The teachings of Livesey, Krejci, Rosson are relied upon as set forth above.
This rejection addresses the embodiment of allogeneic absorbable demineralized bone fibers for the generic biological substance of claim 27 and the generic allograft tissue form of claim 28, and for the absorbable fiber for claims 29 and 17.
Regarding claims 27-30, Livesey, Krejci, and Rosson do not teach adding absorbable demineralized bone fibers.
Rosenberg teaches methods of making demineralized bone matrix fibers capable of grafting/absorbing onto to bone (Abstract, Examples 3-6 for different formulations, Example 7 for implantation) and obtained from allogeneic sources (Col. 3, lines 1-5), reading on claims 27-30. Rosenberg envisions adding osteoconductive compounds such as collagen and collagen derivatives (Col. 7, lines 14-24), reading on claims 27-30. Rosenberg teaches that all short fiber demineralized bone matrix compositions showed bone formation and osteoblastic activity (Col. 13, lines 42-49).
Regarding claims 27-30, it would have been obvious before the invention was made to add the short fiber demineralized bone matrix compositions of Rosenberg to the acellular dermal matrix of Livesey. A person of ordinary skill in the art would have had a reasonable expectation of success in making the addition because Rosenberg envisions adding collagen to the short fiber demineralized bone matrix compositions and because Livesey teaches that the acellular dermal matrix composition comprises collagen. The skilled artisan would have been motivated to make the addition because Rosenberg teaches that short fiber demineralized bone matrix compositions are predictably advantageous in methods of bone healing.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill at the time the invention was made.
Claims 29 and 31 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Livesey, Krejci, and Rosson and as applied to claim 20 above, and further in view of Butler (2004, Plast. Reconstr. Surg., v114, p464-473; provided in the IDS submitted on 4/22/2025).
The teachings of Livesey, Krejci, and Rosson are relied upon as set forth above.
Regarding claims 29 and 31, Livesey, Krejci, and Rosson do not teach adding one or more non-absorbable fibers as reinforcing elements.
Butler teaches composite implant compositions comprising AlloDerm (i.e. a decellularized human dermal composition) and polypropylene (Abstract), reading on claims 29 and 31. Butler teaches there is a need in the art to improve or reduce abdominal adhesions when using prosthetic mesh (crossover paragraph on pages 464-465). Butler teaches that permanent and biodegradable substrates have been considered by skilled artisans as a barrier to separate prosthetic mesh and intraabdominal structures at the repair site (crossover paragraph on pages 464-465). Butler teaches that a composite mesh comprising polypropylene and AlloDerm is particularly advantageous as a graft material in methods of repairing hernias by reducing adherence of the graft to the abdominal tissues and by reduction of scar tissue (Table 1; Figure 3; p467, subheading “Gross Results”; p467-468, subheading “Histological Results”), reading on claims 29 and 31.
Regarding claims 29 and 31, it would have been obvious before the invention was made to combine the acellular dermal matrix of Livesey with the polypropylene of Butler. A person of ordinary skill in the art would have had a reasonable expectation of success in making the addition because Livesey and Butler are directed to the compositions comprising acellular dermal matrices. The skilled artisan would have been motivated to make the addition because Butler teaches that a composite mesh comprising polypropylene and an acellular dermal equivalent is particularly advantageous as a graft material in methods of repairing hernias by reducing adherence of the graft to the abdominal tissues and by reduction of scar tissue.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill at the time the invention was made.
Response to Arguments
Applicant's arguments on pages 7-30 of the reply have been fully considered, but not found persuasive of error for the reasons given below. Applicant’s specific remarks traversing the rejections of record start at page 13 of the reply.
On pages 13-14 of the reply, Applicant alleges that the instant amendments to claim 20 overcomes the new matter rejections of record. This is not found persuasive of error as claim 20 was not amended with the instant reply.
On pages 14-15 of the reply and again on pages 20 and 23-25, Applicant alleges that Livesey and/or Krejci teach away from the claimed invention. This is not found persuasive, because nothing in Livesey and/or Krejci as cited by Applicant criticizes, discredits, or otherwise discourages the claimed solution; See M.P.E.P. § 2145(X)(D). Regarding Livesey on page 20 of the reply, that Livesey does not teach every element of claim 20 is not disputed. However, Livesey is not applied alone under any anticipation rejection under 35 U.S.C. § 102, but in combination with Krejci and Rosson under 35 U.S.C. § 103, and the claimed invention becomes prima facie obvious when the references are considered together as a whole rather than each alone and none of Applicant’s arguments address the specific rationale to combine Krejci and Rosson with Livesey as set forth in above in the rejections of record to reject claim 20. Regarding Krejci on pages 23-25 of the reply, Applicant’s arguments are not persuasive as they completely ignore the teachings of Krejci at p844-845 as cited above in the rejections of record wherein Krejci expressly degrades/removes the basement membrane. The relevant portion of Krejci is reproduced below:
“In order to degrade components of the basement membrane, DED was incubated in trypsin 1: 250 (GIBCO) at 37°C for 5 h and then transferred to culture medium containing 10% calf serum to inactivate the trypsin.”
In response to applicant’s argument on page 15 of the reply that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the arguments are not persuasive because again, none of Applicant’s arguments address the specific rationale to combine Krejci and Rosson with Livesey as set forth in above in the rejections of record.
On pages 16-20 of the reply, Applicants urge that Livesey is deficient by teaching a combination of papillary and reticular dermis. This is not found persuasive because Livesey is not applied alone under any anticipation rejection under 35 U.S.C. § 102, but in combination with Krejci under 35 U.S.C. § 103, and the claimed invention becomes prima facie obvious when the references are considered together as a whole rather than each alone. Again, none of Applicant’s arguments address the specific rationale to combine Krejci with Livesey as set forth above in the rejections of record. Furthermore, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Applicant is alleging error over Livesey alone, but the rejections of record are over the combination of Livesey and Krejci and Applicant’s arguments do not persuasively address what the combination of references would (or would not) suggest to a person of ordinary skill in the art.
Applicant’s arguments on pages 21-27 of the reply, because while Applicant acknowledges that the rejections of record are over Livesey in view of Krejci and Rosson, Applicant then proceeds to repeat the preceding and piecemeal arguments over only Livesey and does not present any arguments over what the combination of Livesey in view of Krejci and Rosson would (or would not) suggest to a person of ordinary skill in the art.
On pages 27-28 of the reply, Applicants rely on arguments traversing the above rejection of claims 20 and 23-26 over Livesey in view of Krejci and Rosson to traverse the rejection of claim 22 further in view of Griffey, claims 27-30 further in view of Rosenberg, and claims 29 and 31 further in view of Butler. Therefore, the response set forth above to arguments also applies to this rejection.
In so much that the elected claims under consideration on the merits are not in condition for allowance at this time, Applicant’s request for rejoinder on pages 28-29 of the reply is not persuasive. See M.P.E.P. § 821.04 for general guidance regarding rejoinder of non-elected claims.
Conclusion
No claims are allowed. No claims are free of the art.
THIS ACTION IS MADE FINAL. 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 SEAN C BARRON whose telephone number is (571) 270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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