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
Applicants’ election without traverse of Group 1 and the species of trehalose (claim 1) in the reply filed on April 3, 2025 is acknowledged. Applicants did not indicate explicitly whether the election was with or without traverse. Because Applicants did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 1, 4 and 11 have been amended. Claims 5-10 and 12-14 have been canceled. Claim 15 has been added. Claims 1-4, 11 and 15 are examined on the merits herewith.
Claim Objections
Claim 15 is objected to because of the following informalities. Appropriate correction is required. It is understood that the documents in the instant application may be a machine or literal translation from the Japanese. Nevertheless, claim 15 should be amended as shown below, to recite the limitations in standard and correct English.
15. (currently amended) The method according to claim 2, wherein the proportion of the fibroblasts in the G2 phase of the cell cycle is 1 to 50% of all fibroblasts that constitute the dermal cell structure.
Claim Rejections - 35 USC § 112, (b)
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.
Claims 1-4, 11 and 15 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. The claims are indefinite, because they are vague and ambiguous. In claim 1, are the fibroblasts treated with a trehalose solution, or a trehalose-containing culture medium, and then removed from this solution or medium and subsequently co-cultured with keratinocytes in a second culture medium? Or are the two kinds of cells co-cultured in a medium comprising trehalose? An interpretation is needed to provide Applicants with expedited prosecution. The claim has been interpreted to mean either possibility, either type of cell culture. Clarification and appropriate correction are required.
In claim 2, are the fibroblasts cultured inside a cell support, to create the dermal cell structure, or are they culture on the cell support externally? An interpretation is needed to provide Applicants with expedited prosecution. The claim has been interpreted to mean either possibility, either type of cell culture. Clarification and appropriate correction are required.
In claim 3, what is the epithelial tissue layer separated from? An interpretation is needed to provide Applicants with expedited prosecution. The claim has been interpreted to mean that the epithelial tissue layer, the co-culture of the two cell types on the cell support, is removed from the container encasing the cell support (a cell culture dish or flask or bioreactor), so that the construct, the co-culture on the cell support, can be implanted in or on a subject in need thereof suffering from a skin wound or skin damage, for skin tissue regeneration and repair. Clarification and appropriate correction are required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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) 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Hashimoto et al. (WO 2007/029676 A1), cited in Applicants’ PCT application and IDS of Feb. 25, 2022, an English machine translation of which is referred to, as Examiner cannot read Japanese. Hashimoto et al. disclose a method making an epithelial tissue layer, for wound repair and skin regeneration, comprising culturing epithelial keratinocytes on a support comprising epithelial fibroblasts. The support is amniotic tissue, an amniotic membrane, that was treated with a solution of trehalose, at a concentration of 5 – 20%, w/v (50-200 mg/ml). The trehalose strengthens the amniotic membrane, normalizes its moisture content, improves its cohesion and elasticity and makes the amniotic membrane less antigenic. Multiple epithelial tissue layer constructs can be prepared and stacked on top of each other and next to each other, to create larger constructs for skin tissue repair and regeneration.
See Abstract and paragraphs 1, 2, 8, 17 (the composition/structure is highly therapeutic and safe) on pp. 4-5 (paragraphs 1 and 4; this paragraph is eight paragraphs long), 23, 24 (paragraphs 1 and 3; this paragraph is six paragraphs long), 26-29, 41 (this paragraph is six paragraphs long), 45, and section 6 on pp. 15-16. See claims 1, 2 and 4.
The epithelial tissue layer construct was removed from the culture vessel and incubator in which it was made and transplanted onto a subject in need thereof (a murine subject). Thus, it was separated. See paragraphs 79 and 80. See claim 3.
The reference does not use the same words that Applicants do, particularly as both documents are translations from the Japanese. But the reference discloses the subject matter of the claims. In view of the foregoing, a holding of obviousness is required.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Hashimoto et al. (WO 2007/029676 A1), cited in Applicants’ PCT application and IDS of Feb. 25, 2022, an English machine translation of which is referred to, as Examiner cannot read Japanese, in view of Boquest et al. (“Flow cytometric cell cycle analysis of cultured porcine fibroblast cells,” Biology of Reproduction 60:1013-1019, 1999). The teachings of Hashimoto et al. are discussed above; Hashimoto et al. do not disclose the percentage of the fibroblasts that are in the G2 phase of the cell cycle.
Boquest et al. studied fibroblasts as fetal fibroblasts and measured concurrently the amounts of DNA and protein in the fibroblasts that were separated into their fraction/phase of the cell cycle by cytometry. Fibroblasts that were proliferating (referred to as “cycling”) and those that were stationary, in confluent culture, were studied. The G2 phase fibroblasts in proliferating culture were present at a level of 18.2%. The G2 fibroblasts in stationary/confluent culture were present at a level of 8.8%. See Table 1 on p. 1016. Expectedly, most of the cells in the G2 phase (diploid) were large, not medium or small. See Table 2 on p. 1016. Fibroblasts in the G2 and M phases were measured together, because cells in these two phases cannot be distinguished on the basis of DNA + protein content alone. Nevertheless, the artisan of ordinary skill at the time that the invention was filed would have had every expectation, and would have had at least a reasonable expectation, that at least 1% of the fibroblasts and less than 50% of the fibroblasts in the whole culture were in the G2 phase. That is, if about 9% of the fibroblasts in stationary culture were in the G2 phase, as a reasonable expectation, at least 1%, at least 1/9 of these fibroblasts, would have been in the G2 phase. This claim does not distinguish the invention over the prior art.
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The first cited reference, Hashimoto et al., do not disclose that the trehalose concentration in the solution used to treat the cell support on which the fibroblasts are cultured has a concentration of 10 mg/ml, or 1% w/v.
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/ROSANNE KOSSON/Primary Examiner, Art Unit 1759 2025-04-07
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