DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claims 11-20 as amended on 9/18/2024 are currently pending and under consideration on the merits.
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.
Claims 11-20 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 terms “substantially” in claim 11 and “about” in claims 11-13, 16, 17, and 20 are relative terms which renders these claims indefinite. The terms “substantially” and “about” are not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification and/or correction is required.
Because claims 12-20 depend from claim 11 and do not resolve the point of confusion, these claims must also be rejected with claim 11 as indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 11-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
Independent claim 11 recites a natural product, collagenase type I and type II, which is naturally found in the microorganism Clostridium histolyticum. For example, see ¶0004 of Sabatino et al. (US 2007/0224183; provided in the IDS dated 12/06/2024). At this time, there is no evidence of record that the claimed collagenase enzymes possess any markedly different characteristic than their natural counterpart. See M.P.E.P. § 2106.04(c).
Regarding the purity and “substantially” clostripain-free limitations of claim 11, this judicial exception is not integrated into a practical application because and do not include additional elements that are sufficient to amount to significantly more because it was routine and conventional in this art to purify collagenase type I and II from Clostridium histolyticum to at least 95% purity and substantially clostripain-free in view of Sabatino. Sabatino teaches a composition comprising isolated and purified collagenase I and II from Clostridium histolyticum wherein the collagenase I and the collagenase II are substantially clostripain-free (e.g. < 1% by area) and at least 95% pure by area as measured by reverse phase high pressure liquid chromatography (RP-HPLC) (¶0360 and Table A).
Regarding the product-by-process limitations of claims 11-20, this judicial exception is not integrated into a practical application and do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no evidence of record that the product-by-process limitations impart any markedly different characteristic to the claimed collagenase enzymes as compared to their natural counterpart. See M.P.E.P. § 2106.04(c)(I)(B) and 2113, in that product-by-process claims are not limited to the manipulations of the recited steps but only any structure implied by said steps.
For the reasons above, claims 11-20 are rejected as patent ineligible under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102 and 103
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 –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
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).
Claims 11-20 are rejected under pre-AIA 35 U.S.C. 102 (b) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Sabatino et al. (US 2007/0224183; provided in the IDS dated 12/06/2024).
Sabatino teaches a composition comprising isolated and purified collagenase I and II from Clostridium histolyticum wherein the collagenase I and the collagenase II are substantially clostripain-free (e.g. < 1% by area) and at least 95% pure by area as measured by reverse phase high pressure liquid chromatography (RP-HPLC) (¶0360 and Table A), made by a method comprising a) fermenting Clostridium histolyticum; b) harvesting a crude product comprising collagenase I and collagenase II; c) purifying collagenase I and collagenase II from the crude harvest via filtration and column chromatography; and d) combining the collagenase I and collagenase II purified from step (c) at a ratio of about 1 to 1. (¶0361-0366), anticipating or reading on claims 11-20.
In a separate embodiment, Sabatino teaches a preferred culture medium for producing the collagenase, the medium comprising greater than 9 g/L salts, Phytone (i.e. vegetable peptone), yeast extract, potassium phosphate, dipotassium phosphate, disodium phosphate, sodium chloride, ferrous sulfate, riboflavin, niacin, and calcium pantothenate (the table between ¶0516 and ¶0517), anticipating or reading on the culture medium of claims 11-15 and 18. Sabatino teaches that the Phytone is present at 4.68% w/v (the table between ¶0516 and ¶0517, calculated by (65.45 g ÷1400 ml) * 100), anticipating or reading on claims 16 and 17.
Claim 11 is a product-by-process claim. Claims 12-20 depend from claim 11 and recites product-by-process limitations. M.P.E.P. § 2113; product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. Furthermore, alternate grounds of rejection under both 102 and 103 is permissible given the lack of physical description of product-by-process claims and the inability of the USPTO to manufacture and compare products. See M.P.E.P. § 2113 (III). Once a product appearing to be substantially identical is found and an art rejection made, the burden shifts to the applicant to show an unobvious difference. In this case, the burden is shifted to Applicant to show that the manufacturing process steps of the product-by-process claims impart any novel and/or non-obvious structural characteristics to the claimed product as compared to the composition taught by Sabatino. Sabatino teaches a substantially identical composition comprising isolated and purified collagenase I and II from Clostridium histolyticum wherein the collagenase I and the collagenase II are substantially clostripain-free (e.g. < 1% by area) and at least 95% pure by area as measured by reverse phase high pressure liquid chromatography (RP-HPLC). Particularly, if the product-by process limitations of claims 11-20 impart no structural difference then the claims are anticipated. If the product-by process limitations of claims 11-20 impart a structural difference, then Applicant must clearly set forth why any structural difference between the claimed composition and the composition of Sabatino is non-obvious.
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.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:00am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653