DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 05/13/2026 is acknowledged.
Status of Application
Applicant has elected Group I in response to restriction requirement and for the examination.
Due to restriction, based on election of Group I, claims 5-8 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-8 are pending.
Claims 1-4 are present for examination at this time.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park et al. (WO 2023/282593).
U.S. Pat. Pub. 2024/0285828 is the national stage document of WO 2023/282593 and will be used as the translation. All references are to the U.S. Pat. Pub.
Rejection:
Park et al. teaches and claims a fibrotic acellular dermal matrix which comprises 0.5-20%wt water, has stem cells and/or growth factors, and a sheet (claims 10-17).
Accordingly the claims are anticipated.
The following is a quotation of the appropriate paragraphs of 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 –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Park et al. (WO 2023/282593).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
U.S. Pat. Pub. 2024/0285828 is the national stage document of WO 2023/282593 and will be used as the translation. All references are to the U.S. Pat. Pub.
Rejection:
Park et al. teaches and claims a fibrotic acellular dermal matrix which comprises 0.5-20%wt water, has stem cells and/or growth factors, and a sheet (claims 10-17).
Accordingly the claims are anticipated.
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Shin et al. (WO 2023/195633) in view of Livesey et al. (U.S. Pat. Pub. 2003/0035843).
U.S. Pat. Pub. 2025/0229000 is the national stage entry of WO 2023/195633 and serves as the translation of WO 2023/195633, all references are to the U.S. Pat. Pub.
It is noted that the instant composition claims are set forth in the form of product-by-process which are considered as product claims.
Rejection:
Shin et al. teaches a decellularized acellular dermal tissue with improved mechanical properties and improved levels of extracellular matrix preservation (abstract, [6, 7-9], claims 1-2, 4 and 12). The acellular dermal grafts maintains the structural proteins and three-dimensional structure of the tissue the dermis contains collagen fibers and elastin woven to have a mesh shape [30-31], has a Young’s modulus of 0.5-1.2 MPa (tensile strength, 0.5-1.2 MPa=0.5-1.2 N/mm2), contains growth factors like FGF-2 (claim 4, [20-21, 86-87]), and freeze-dried with a sugar and sugar alcohols. The samples are sheets (see Figure 1). Example 1 is a acellular dermal matrix sample (ADM) treated with NaCl, PBS, decellularized, rinsed with PBS, and either packaged as ready to use or freeze dried with malitol [144-147]; confirms the presence of growth factors in Example 5; and rehydrates it in Example 7 (see full document specifically areas cited).
Shin et al. does not expressly recite the water/moisture content of the ADM but does teach the ADM in freeze-dried and rehydrated form.
Livesey et al. teaches that it is known that when freeze-drying an ADM the residual moisture content is less than 6% and optimally 2% [149], and when rehydrating the ideal is at least 15% when using vapor rehydration and when using fluid rehydration to be between 20-70% [26].
Wherein it would be obvious to one of ordinary skill in the art to have the optimal water content of 2% in the freeze-dried ADM as suggested by Livesey et al. and produce the claimed invention; as it is prima facie obvious to have the freeze-dried ADM at the known optimal moisture content with a reasonable expectation of success.
In is noted that the instant claims are set forth in the form of product-by-process claims, which are considered product claims by the Office. Applicants are reminded that process limitations cannot impart patentability to a product that is not patentably distinguished over the prior art. In re Thorpe et al. (CAFC 1985), supra; In re Dike (CCPA 1968) 394 F2d 584, 157 USPQ 581; Tri-Wall Containers, Inc. v. United States et al. (Ct Cls 1969) 408 F2d 748, 161 USPQ 116; In re Brown et al. (CCPA 1972) 450 F2d 531, 173 USPQ 685; Ex parte Edwards et al. (BPAI 1986) 231 USPQ 981.
Claims 1-2, 4 are rejected under 35 U.S.C. 103 as being unpatentable over Chun et al. (U.S. Pat. 9623149) in view of Livesey et al. (U.S. Pat. Pub. 2003/0035843).
It is noted that the instant composition claims are set forth in the form of product-by-process which are considered as product claims.
Rejection:
Chun et al. teaches an acellular dermal matrix (ADM)where the cells are removed and the cryoprotectant comprises sucrose and is freeze-dried (abstract). The stability of the tissue of the ADM is improved (col. 3 line 21-24, 49-51). An example is prepared (size 5x10gm2 – sheet) which is washed, cells are removed, rinsed with PBS, bathed in the cryoprotectant sucrose liquid, and freeze-dried (Col. 5 line 5-51). It has better stability of tissue (Col. 5 line 52-57). While Chun et al. does recite the exact values for the tensile strength, the product is freeze-dried wherein it is in a stiff state and implicitly greater than 0.2N/mm2 (see Shin et al., N/mm2=MPa, see full document specifically areas cited).
Chun et al. does not expressly recite the water/moisture content of the ADM but does teach the ADM in freeze-dried form.
Livesey et al. teaches that it is known that when freeze-drying an ADM the residual moisture content is less than 6% and optimally 2% [149].
Wherein it would be obvious to one of ordinary skill in the art to have the optimal water content of 2% in the freeze-dried ADM as suggested by Livesey et al. and produce the claimed invention; as it is prima facie obvious to have the freeze-dried ADM at the known optimal moisture content with a reasonable expectation of success.
In is noted that the instant claims are set forth in the form of product-by-process claims, which are considered product claims by the Office. Applicants are reminded that process limitations cannot impart patentability to a product that is not patentably distinguished over the prior art. In re Thorpe et al. (CAFC 1985), supra; In re Dike (CCPA 1968) 394 F2d 584, 157 USPQ 581; Tri-Wall Containers, Inc. v. United States et al. (Ct Cls 1969) 408 F2d 748, 161 USPQ 116; In re Brown et al. (CCPA 1972) 450 F2d 531, 173 USPQ 685; Ex parte Edwards et al. (BPAI 1986) 231 USPQ 981.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Chun et al. (U.S. Pat. 9623149) in view of Livesey et al. (U.S. Pat. Pub. 2003/0035843) as applied to claims 1-2, 4 above, further in view of Chen et al. (CN 106390180).
Rejection:
The teaching of Chun et al. in view of Livesey et al. are addressed above.
Chun et al. in view of Livesey et al. do not expressly teach stem cells or growth factors but do teach an acellular dermal matrix.
Chen et al. teaches that fibroblast growth factor is known to be incorporated in acellular dermal matrixes and it promotes tissue regeneration and repair [4-7].
Wherein it would be obvious to one of ordinary skill in the art to incorporate fibroblast growth factor in the ADM as suggested by Chen et al. and produce the claimed invention; as it is prima facie obvious to incorporate the fibroblast growth factor as it promotes tissue regeneration and repair which is desirable with a reasonable expectation of success.
Conclusion
Claims 1-4 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
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