DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendments
Applicant's amendments filed 3/03/2026 to claims 1 and 6 have been entered. Claim 17 is canceled. 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 Claims 1-5 remain withdrawn from consideration.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.
The instant amendments to claim 6 have overcome the 35 U.S.C. § 112(b), 102, 103, and nonstatutory double patenting rejections of record, which are withdrawn. New grounds of rejection are set forth below necessitated by the instant amendments.
Any other rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 10-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6, from which claims 10-16 depend, was amended in the instant reply to recite a dermal tissue form consisting of reticular dermis. Therefore, claims 10-16 are rejected as indefinite because they recite the broader and open-ended transitional phrase “comprising”. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 10-16 recite the broad recitation of additional limitations based upon the “comprising” transitional phrase and the claims also depends from and must incorporate the limitations of claim 6, and claim 6 recites the transitional phrase “consisting of”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Correction is required.
Claims 10-16 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In this case, claim 6, from which claims 10-16 depend, recites the narrower “consisting of” transitional phrase but claims 10-196 recite the broader “comprising” transitional phrase. Therefore, claims 10-16 fail to limit the scope of claim 6 by broadening the scope of the claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 6 and 10-12 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Krejci et al. (J Invest Dermatol 97:843-848, 1991; Reference U).
Other species were found during the search. This rejection addresses the embodiment of keratinocytes and fibroblasts for claims 10 and 11, and as species of biological substances for claim 12.
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 (also referred to as second cut dermis or SCD) (p843-844, subheading “Dermal Preparations), anticipating claim 6. Krejci teaches adding keratinocytes and fibroblasts (p844, subheading “Keratinocyte and Fibroblast Culture and Seeding”), anticipating those embodiments of claims 10 and 11 and the embodiment of keratinocytes and fibroblasts for the one or more biological substances of claim 12.
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).
Claim 6 and 8-12 are rejected under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Livesey et al. (US 8,067,149) in view of Krejci et al. (J Invest Dermatol 97:843-848, 1991; Reference U).
Livesey teaches a composition comprising an acellular reticular dermal matrix and basement membrane 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), anticipating claim 6 (i.e. the dermatome as a separating tool). 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 claim 6, Livesey does not teach a reticular dermis lacking a basement membrane.
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 (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 6.
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.
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 and Krejci as applied to claim 6 above, and further in view of Griffey et al. (US 7,358,284).
The teachings of Livesey and Krejci are relied upon as set forth above.
Regarding claim 7, Livesey and Krejci 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 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 and Krejci 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 and Krejci are relied upon as set forth above.
Regarding claims 10 and 11, Livesey and Krejci do 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 and Krejci as applied to claim 6 above, and further in view of Rosenberg et al. (US 7,582,309).
The teachings of Livesey and Krejci 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 Krejci 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 and Krejci and as applied to claim 6 above, and further in view of Butler (2004, Plast. Reconstr. Surg., v114, p464-473).
The teachings of Livesey and Krejci are relied upon as stated above.
Regarding claims 14 and 16, Livesey and Krejci 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.
Claims 6, 7, and 10-12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Krejci et al. (J Invest Dermatol 97:843-848, 1991; Reference U) in view of in view of Griffey et al. (US 7,358,284).
The teachings of Krejci are relied upon as set forth above in rejecting claim 6 and 10-12 as anticipated under pre-AIA 35 U.S.C. § 102(b).
Regarding claim 7, Krejci does not teach the reticular dermis composition formulated as a particulate.
Griffey teaches methods of processing an acellular tissue matrix into a particulate acellular tissue matrix (Abstract), reading on claim 7. 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 reticular dermal composition of Krejci 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 Krejci and Griffey are directed towards 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, and so would predictably improve upon the reticular dermis composition of Krejci.
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 6 and 8-12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Krejci et al. (J Invest Dermatol 97:843-848, 1991; Reference U) in view of Livesey et al. (US 8,067,149).
The teachings of Krejci are relied upon as set forth above in rejecting claim 6 and 10-12 as anticipated under pre-AIA 35 U.S.C. § 102(b).
Regarding claim 8, Krejci does not teach a perforated reticular dermis composition. Regarding claim 9, Krejci does not teach the reticular dermis composition formulated as a mesh.
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). Livesey teaches an embodiment comprising formulating the processed dermis as 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 and 9, it would have been obvious to a person of ordinary skill in the art before the invention was made to further formulate the reticular dermis of Krejci into a perforated meshed graft in view of Livesey. 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, and 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 as taught by Livesey, thus improving upon the reticular dermis composition of Krejci.
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 6 and 10-12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Krejci et al. (J Invest Dermatol 97:843-848, 1991; Reference U) in view of Orbay et al. (Aesth Plast Surg (2011), 35, 756-763).
The teachings of Krejci are relied upon as set forth above in rejecting claim 6 and 10-12 as anticipated under pre-AIA 35 U.S.C. § 102(b).
Regarding claims 10 and 11, Krejci does not teach the elected species of stem cells. Regarding claim 12, Krejci does not teach stem cells as a species of biological substance.
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 10-12.
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 reticular dermis composition of Krejci. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Krejci 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 Krejci 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 6 and 10-15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Krejci et al. (J Invest Dermatol 97:843-848, 1991; Reference U) in view of Rosenberg et al. (US 7,582,309).
The teachings of Krejci are relied upon as set forth above in rejecting claim 6 and 10-12 as anticipated under pre-AIA 35 U.S.C. § 102(b). Krejci teaches further adding fibronectin or collagen type IV to the surface of the reticular dermis composition (p845, subheading “Human Reticular Second-cut Dermis (SCD)”), reading in-part on claims 12-15.
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, Krejci does not teach the embodiment of allogeneic 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 reticular dermis composition of Krejci. 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 Krejci teaches in-part adding collagen to the reticular dermis composition. 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, and so the addition would predictably improve upon the reticular dermis composition of Krejci.
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 6, 10-12, 14, and 16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Krejci et al. (J Invest Dermatol 97:843-848, 1991; Reference U) in view of Butler (2004, Plast. Reconstr. Surg., v114, p464-473).
The teachings of Krejci are relied upon as set forth above in rejecting claim 6 and 10-12 as anticipated under pre-AIA 35 U.S.C. § 102(b).
Regarding claims 14 and 16, Krejci does 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 reticular dermis composition of Krejci 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 Krejci 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 in view of Krejci et al. Krejci et al. (J Invest Dermatol 97:843-848, 1991; Reference U).
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.
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.
In same order as presented, claims 2-13 of the ‘501 patent read on instant claims 7-16.
Regarding claim 6, claim 1 of the ‘501 patent does not claim an allograft tissue form consisting of reticular dermis.
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 (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 6.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to further remove any additional skin tissue from the reticular dermis composition of the ‘501 patent 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 the ‘501 patent 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 ‘501 patent
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Response to Arguments
Applicant's arguments on pages 6-18 of the reply have been fully considered, but not found persuasive of error over the entirely new grounds of rejection set forth above and necessitated by the claim amendments.
Any arguments regarding Livesey as applied under 35 U.S.C. § 103 are not persuasive over the new grounds of rejection above, which now include Krejci as a secondary reference.
Conclusion
No claims are allowed. No claims are free of the art.
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.
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/Sean C. Barron/Primary Examiner, Art Unit 1653