DETAILED ACTION
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 .
Claims 1-14 are pending. Claims 1-14 are examined on the merits.
Claim Rejections –35 USC § 112, 2nd
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.
Claim 11 is rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 11 recited the following limitations in the claims, and there are insufficient antecedent basis for these limitations in the claims:
“wherein the step of separating an epidermal layer and a dermal layer…” in claim 11, at lines 1-2.
Therefore, the metes and bounds of claims are rendered vague and indefinite. The lack of clarity renders the claims very confusing and ambiguous since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
All other cited claims depend directly or indirectly from rejected claims and are, therefore, also, rejected under U.S.C. 112, second paragraph for the reasons set forth above.
Claim Rejections –35 USC § 103
The following is a quotation of 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 through the invention is not identically disclosed or described as set forth in section 102 of this title, 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 negatived by the manner in which the invention was made.
Claims 13 and 14 are rejected under 35 U.S.C. 103(a) as being unpatentable over Bai et al (CN 111265718 A) (see IDS filed on 10/7/24).
Bai et al teach an acellular dermal tissue preparation method comprising the steps of: separating skin tissue, which is isolated from a subject, into epidermis and dermis (thus claim 13 a) is met); and obtaining acellular dermis from the separated dermis, using a supercritical fluid extraction device (thus claim 13 b) is met), and the feature wherein the acellular dermal tissue has good biocompatibility and is widely used in various fields such as burns and plastic surgery (see paragraph [0002] and claim 1). Bai et teach in step S6, during the supercritical CO_NER25 extraction process of the dermal matrix, 50ml to 100ml of entrainer is added [0047], and the entrainer is ethanol (thus claim 14 is met), hydrogen peroxide, or peracetic acid [0048]. Bai et teach according to current reports, decellularized dermal matrix is usually treated with surfactants or enzymes, such as sodium dodecyl sulfate, tributyl phosphate (thus the claimed phosphate buffer), sodium deoxycholate, Triton X-100, trypsin, pepsin or neutral protease. Most of the above chemical reagents are toxic to some extent. If the reagents remain, they will inevitably lead to adverse reactions in the body. In addition, excessive chemical treatment [0004]. Bai et teach second cleaning: The dermal matrix after the epidermis has been removed is cleaned again with purified water for 15 to 30 minutes [0013].
Bai et al do not teach washing the dermal layer extracted with a supercritical fluid with a phosphate buffer (claim 13 c).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to wash the dermal layer extracted with a supercritical fluid with a phosphate buffer since Bai et al teach the dermal matrix after the epidermis has been removed is cleaned again with purified water for 15 to 30 minutes and decellularized dermal matrix is usually treated with surfactants or enzymes, such as tributyl phosphate (thus the claimed phosphate buffer) etc. Determining an appropriate washing agent is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the references, it is apparent that one of the ordinary skills in the art would have had a reasonable expectation of success in producing the claimed invention.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Conclusion
Claims 1-10, and 12 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QIUWEN MI whose telephone number is (571)272-5984. The examiner can normally be reached on Monday-Friday 9:00 am to 5:00 pm.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655
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