Patent Application 18926991 - SOFT TISSUE REPAIR ALLOGRAFTS AND METHODS FOR - Rejection

Patent Application 18926991 - SOFT TISSUE REPAIR ALLOGRAFTS AND METHODS FOR

Title: SOFT TISSUE REPAIR ALLOGRAFTS AND METHODS FOR PREPARING SAME

Application Information

• Invention Title: SOFT TISSUE REPAIR ALLOGRAFTS AND METHODS FOR PREPARING SAME
• Application Number: 18926991
• Submission Date: 2025-05-16T00:00:00.000Z
• Effective Filing Date: 2024-10-25T00:00:00.000Z
• Filing Date: 2024-10-25T00:00:00.000Z
• Examiner Employee Number: 89188
• Art Unit: 1653
• Tech Center: 1600

Rejection Summary

• 102 Rejections: 0
• 103 Rejections: 5

Cited Patents

No patents were cited in this rejection.

Office Action Text

    DETAILED ACTION
The present application is being examined under the pre-AIA  first to invent provisions. 

Response to Amendments
Applicant's amendments filed 5/06/2025 to claim 6 have been entered. Claims 1-16 remain pending, of which claims 6-16 are being considered on their merits. Claims 1-5 remain withdrawn from consideration. References not included with this Office action can be found in a prior action. 
Applicant’s arguments on pages 14-15 of the reply are found persuasive, and the statutory double patenting rejections of record are withdrawn.
Any other rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.

Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA  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 –

(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.

Claim 6 is rejected under pre-AIA  35 U.S.C. § 102 (b) as anticipated by Livesey et al. (US 8,067,149) as evidenced by Shuster et al. (1975, British Journal of Dermatology, v93, p639-643) and a schematic structure of the skin by Ownby (2010; of record).
Other species were found during the search. This rejection addresses the embodiment of keratinocytes for claims 10-12.
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), either anticipating claim 6 (i.e. the dermatome as a separating tool). 
Regarding claim 6 directed towards (collagen matrix) density, skin collagen matrix density is an inherent/latent property as evidenced by Shuster, who teaches that skin collagen density (thus understood as the inverse to porosity) depends on the age and sex of the subject (Summary). Furthermore, any distribution of collagen density between the different skin layers is simply a latent property of the donor skin taught Livesey that reads on claim 6; Livesey teaches the same composition as claimed (i.e. donor skin) and so any properties are necessarily inherent to that structure, see In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the teachings of Livesey as evidenced by Shuster reads on the collagen matrix density of claim 6.
Regarding the wherein clause of claim 6 directed towards rapid and efficient cellular ingrowth, the composition of Livesey is reasonably presumed capable of meeting the intended use of the claim absent any persuasive showing to the contrary. See M.P.E.P. § 2111.02 and 2111.04 for further guidance on statements of intended use.
Regarding claim 6 Livesey is silent if the remaining dermis comprises papillary and reticular dermis. However, Ownby is relied upon as evidentiary support that the layered structure of intact skin from the outermost surface to the innermost surface comprising: the epidermis, the papillary dermis, the reticular dermis, and the hypodermis was known before the invention was made (see the figure next to “structure of the skin” and the upper figure next to “two zones of the dermis). Therefore, the teachings of Livesey towards obtaining skin and removing the epidermis from the dermis and retaining the dermis as cited above inherently reads on the papillary dermis and reticular dermis of claim 6 of skin as evidenced by Ownby. 

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 6 and 8-12 are rejected under pre-AIA  35 U.S.C. 103(a) as being unpatentable over Livesey et al. (US 8,067,149) as evidenced by Shuster et al. (1975, British Journal of Dermatology, v93, p639-643) and a schematic structure of the skin by Ownby (2010; of record).
The teachings of Livesey as evidenced by Shuster and Ownby are relied upon as set forth above in rejecting claim 6 as anticipated under pre-AIA  35 U.S.C. § 102(b).
Livesey further teaches an embodiment comprising the processed dermis and meshed graft and having a number of clinical applications in full thickness skin injury such as the treatment of burn patients (Col. 23, line 60-67), reading on claims 8 and 9. Livesey teaches an embodiment of reconstituting the acellular dermal matrix with cells such as keratinocytes (Col. 6, lines 39-49) and having a number of clinical applications in full thickness skin injury such as the treatment of burn patients (Col. 23, line 60-67), reading on claims 10 and 12 and the embodiment of keratinocytes for claim 11. 
Regarding claims 8-9, it would have been obvious to a person of ordinary skill in the art before the invention was made to further formulate the processed dermis of Livesey into a meshed graft as further taught by Livesey.  A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Livesey expressly considers the formulating the processed dermis as a meshed graft. The skilled artisan would have been motivated to do so because the further formulation would be predictably advantageous to then clinically treat subjects suffering from burn injuries.
Regarding claims 10-12, it would have been obvious to a person of ordinary skill in the art before the invention was made to further add keratinocytes to the processed dermis of Livesey A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Livesey expressly considers the combination. The skilled artisan would have been motivated to do so because the combination would be predictably advantageous to then clinically treat subjects suffering from burn injuries.
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.

Claim 7 is rejected under pre-AIA  35 U.S.C. 103(a) as being unpatentable over Livesey as evidenced by Ownby as applied to claim 6 above, and further in view of Griffey et al. (US 7,358,284).
The teachings of Livesey as evidenced by Ownby are relied upon as set forth above.
Regarding claim 7, Livesey as evidenced by Ownby does 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 9. 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 7. Griffey teaches forming the particulate acellular dermal matrix in-part by cryofracturing (Col. 8, lines 26-63), reading on claim 7.
It would have been obvious before the invention was made to further process the acellular dermal matrix of Livesey into a particulate formulation according the 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 10 and 11 rejected under pre-AIA  35 U.S.C. 103(a) as being unpatentable over Livesey as evidenced by Shuster and Ownby as applied to claim 6 above, and further in view of Orbay et al. (Aesth Plast Surg (2011), 35, 756-763).
The teachings of Livesey as evidenced by Shuster and Ownby are relied upon as set forth above.
Regarding claims 10 and 11, Livesey as evidenced by Shuster and Ownby does not the elected species of stem cells.
Orbay teaches that adding autologous adipose-derived stem cells to acellular dermal matrix improves the collagen content of said matrix and improves the durability of acellular dermal matrix as a soft tissue filler (Abstract), reading on claims 10 and 11. Orbay teaches that soft tissue augmentation is sometimes required for both aesthetic and reconstructive purposes (p756, 1st paragraph under the Abstract in the right column), reading on claims 10 and 11.
It would have been obvious to a person of ordinary skill in the art before the invention was made to further add the adipose-derived stem cells of Orbay to the acellular 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 Livesey and Orbay are directed in-part towards acellular dermal matrix compositions comprising mammalian cells.  The skilled artisan would have been motivated to do so because combination would predictably enhance the properties of the acellular dermal matrix of Livesey to be a suitable soft tissue filler material to subjects in need thereof.
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 12-15 are rejected under pre-AIA  35 U.S.C. 103(a) as being unpatentable over Livesey as evidenced by Ownby as applied to claim 6 above, and further in view of Rosenberg et al. (US 7,582,309).
The teachings of Livesey and as evidenced by Ownby are relied upon as stated above. This rejection addresses the embodiment of allogeneic absorbable demineralized bone fibers for the generic biological substance of claim 12 and the generic allograft tissue form of claim 13, and for the absorbable fiber for claims 14 and 15.
	Regarding claims 12-15, Livesey and as evidenced by Ownby 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 12-15. Rosenberg envisions adding osteoconductive compounds such as collagen and collagen derivatives (Col. 7, lines 14-24), reading on claims 14-17. Rosenberg teaches that all short fiber demineralized bone matrix compositions showed bone formation and osteoblastic activity (Col. 13, lines 42-49).
Regarding claims 12-15, 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 14 and 16 are rejected under pre-AIA  35 U.S.C. 103(a) as being unpatentable over Livesey as evidenced by Ownby and as applied to claim 6 above, and further in view of Butler (2004, Plast. Reconstr. Surg., v114, p464-473).
The teachings of Livesey as evidenced by Ownby are relied upon as stated above.
Regarding claims 14 and 16, Livesey as evidenced by Ownby 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 14 and 16. 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 14 and 16.
Regarding claims 14 and 16, 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.

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 6-16 are  rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,881,501 B2. 
Note that there are exceptions to the prohibition against nonstatutory double patenting rejections under 35 U.S.C. § 121. See M.P.E.P. §  804.01. In this case, no restriction was made in parent case 16/244,190 before US Patent No.10,881,501 B2  issued.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 6 of the ‘501 patent is directed towards the narrower embodiment of an allograft dermal tissue form for use in surgical procedures, comprising a portion of dermal tissue derived from a sample of dermal tissue recovered from a donor and comprising an upper portion of papillary dermis, a lower portion of papillary dermis, and a reticular dermis, wherein the portion of dermal tissue has a first exposed surface formed by a first cut and a second exposed surface formed by a second cut opposite said first exposed surface, said portion of dermal tissue comprising a collagen matrix having uniform density and porosity between said first exposed surface and said second exposed surface, and wherein the portion of dermal tissue comprises at least a portion of the lower portion of papillary dermis and at least a portion of the reticular dermis and essentially lacks an epidermis, a dermis-epidermis junction, the upper portion of papillary dermis and a hypodermis., thus reading on instant claim 6.
Regarding the wherein clause of claim 6 directed towards rapid and efficient cellular ingrowth, the composition of claim 1 of the ‘501 patent is reasonably presumed capable of meeting the intended use of the claim absent any persuasive showing to the contrary. See M.P.E.P. § 2111.02 and 2111.04 for further guidance on statements of intended use.
In same order as presented, claims 2-13 of the ‘501 patent read on instant claims 7-16.


Response to Arguments
Applicant's arguments on pages 7-16 of the reply have been fully considered, but not found persuasive of error for the reasons given below.
Regarding claim 6 and Applicant’s arguments on pages 7-8 and again on pages 9-10 of the reply, while “consisting essentially of” occupies a middle ground between fully closed and open claims, Applicant also bears the burden to clearly set forth what materials and/or steps that would not affect the basic and novel characteristics of the claimed invention; absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” See M.P.E.P. § 2111.03. In this case, since the specification in this case does not particularly point out the basic and novel characteristics of the claimed composition, “consisting essentially of” in claim 6 has been interpreted as “comprising” for the purpose of art rejections. Therefore, the additional skin layers of Livesey alleged as erroneous are permitted within the scope of independent claim 6 as “consisting essentially of” has been construed as equivalent to “comprising”.
Regarding Applicant’s arguments on page 8 and again on page 10 of the reply, collagen density is an inherent property of the skin of Livesey. Because Livesey teaches the same composition as claimed (i.e. donor skin and defaulting to the “comprising” transitional phrase), any properties are necessarily inherent to that structure, see In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the teachings of Livesey as evidenced by Shuster reads on the collagen matrix density of claim 1 absent any showing or claim amendments to the contrary.
On page 10 of the reply, Applicant appears to allege error over Livesey by not selecting several dermal layers for removal. This is not found persuasive of error because Livesey clearly teaches removing the epidermis leaving behind the dermis and reticular dermis, and collagen density is an inherent property of the skin of Livesey for the reasons given in the preceding paragraph.
	On pages 10-11 of the reply, Applicant appears to allege that Livesey is deficient by not teaching every product-by-process limitation of claim 6. This is not found persuasive because product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps; see M.P.E.P. §  2113. In this case, Livesey clearly teaches a dermal tissue composition comprising reticular dermis, thus anticipating claim 6 (while noting “consisting essentially of” has defaulted to “comprising”).
On pages 11-13 of the reply, Applicants rely on arguments traversing the above rejection of claim 6 over Livesey and under 35 U.S.C. § 102 to traverse this rejection of claims 6 and 8-12 under 35 U.S.C. § 103. Therefore, the response set forth above to arguments also applies to this rejection. Also regarding claim 6, "lack of novelty is the epitome of obviousness." May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974)).
	Applicant’s request for rejoinder on pages 13-14 of the reply is acknowledged, but not persuasive at this time as no allowable subject matter has been indicated. The withdrawn claims will be considered for rejoinder when and if such time that the elected claims are found allowable.
	Applicant’s arguments regarding the non-statutory double patenting rejection of record is acknowledged, but not found persuasive of error.

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 7:00am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653