Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-9, 11-16, 18, 20-36, 41-49, 57, 60, and 105) in the reply filed on 9/9/26 is acknowledged.
Claims 50-53 100 and107 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/9/26.
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed 7/28/26, 6/26/26 and 4/21/26. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
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)(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.
Claim(s) 1-5, 60 and 105 is/are rejected under 35 U.S.C. 102(a2) as being anticipated by Tumey et al. (US 2015/0140058).
Tumey et al. teach with regards of instant claim 1, wherein the skin tissue is removed from a small area of the donor (see 0050 0086), wherein the skin is placed in a container (See 0086) in a cultured medium i.e., sterile medium)wherein the sample comprises solution is separated, or the medium comprises fibroblast and keratinocytes (see 0076). With regards to instant claim 2, Tumey also teaches the medium comprises keratinocytes and fibroblast (see 0076 and 0087) that is combined with other matrix such as collagen and extracellular matrix proteins, wherein the cells are separated and are live cells(as required by instant claims 2-3, see 0055-0056, 0085-0092) wherein the skin is dissociated prior to placing in the sterile medium (see same as above, as required by instant claim 4) wherein the skin sample is at least 1 mm2 to 4 cm2 (see 0056, 0074, as required by instant claim 5). With regards to instant claim 60, the reference teaches the skin sample is reshaped and resized (see 0076, 0086-0087) and the skin graft is applied onto the wound (see 0059, as required by instant claim 105, see 0059).
Therefore, instant claims 1-5 and 60 are anticipated by Tumney et al.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-9, 11-16, 18, 20-36, 41-49, 57, 60, and 105 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tumey et al. (US 2015/0140058) in view of Dunbar et al. (WO 2019/066663)..
Tumey et al. teach with regards to instant claim 1, wherein the skin tissue is removed from a small area of the donor (see 0050 0086), wherein the skin is placed in a container (See 0086) in a cultured medium i.e., sterile medium)wherein the sample comprises solution is separated, or the medium comprises fibroblast and keratinocytes (see 0076). With regards to instant claim 2, Tumey also teaches the medium comprises keratinocytes and fibroblast (see 0076 and 0087) that is combined with other matrix such as collagen and extracellular matrix proteins, wherein the cells are separated and are live cells(as required by instant claims 2-3, see 0055-0056, 0085-0092) wherein the skin is dissociated prior to placing in the sterile medium (see same as above, as required by instant claim 4) wherein the skin sample is at least 1 mm2 to 4cm2 (see 0056, 0074, as required by instant claim 5). With regards to instant claim 60, the reference teaches the skin sample is reshaped and resized (see 0076, 0086-0087) and the skin graft is applied onto the wound (see 0059, as required by instant claim 105, see 0059).
However, Tumney failed to teach the specific container (as required by instant claims 6-7and the specific buffer.
Dunbar teaches getting skin sample comprising a dermis and epidermis and treating the sample with an enzyme (see claims 1-2, pg. 32, lines 16+)as required by instant claims 1,16) wherein the skin sample is cut into small sections that is at least 1 mm2 (see claim 12, as required by instant claim 5) in a dish (i.e., a container, see , wherein the cells where incubated at a temperature of 37ºC overnight (as required by instant claim 12-13, see pg. 38, lines 11+) wherein the saline medium is DMEM (as required by instant claim 8, see pg. 37, 5+) and the suspension was centrifuged (i.e., shaked as required by instant claim 20-21, 24, see pg. 38, lines 5+) and centrifuged for 10 mins (see same cited above as required by instant claim 26, thus 10 mins is within the claimed range), wherein the pH value of the matrix is 6.5-8 (as required by instant claim 32-33, see pg. 18, lines 14+)
With regards to instant claims 34 - 36, Dunbar teaches the collagen solution is a solution of Type I, II, III (see Table 1, pg. 24). Since Dunbar teaches the graft can be prepared as a skin patch (see pg. 36, lines 20+).
Although the cited references fail to teach that the samples collected are placed in a test tube or cryovial, nonetheless as evidenced by FACLR teaches skin graft samples are placed in a conical tube or cryovial (see attached). The references are silent in teaching in teaching centrifuging a second time at 1-300 g will depend on the amount of the fibroblast or keratinocyte produced by the graft.
Since both teachings are drawn to the same concept, the adjustment of particular conventional working conditions of preparing a skin graft deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Therefore, one of ordinary skill in the art would have been motivated to combine the cited references to achieve the instant claimed invention with a reasonable expectation of success because they are drawn to the same technical field and the teaching is pertinent to the problem which Applicant (see MPEP 2141.01(a))
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 10/3/26
