DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendments
Applicant's amendments filed 4/14/2026 to claims 11-14, 16, and 17 have been entered. Claims 1-10 canceled. Claims 21-26 have been added. Claims 11-26 remain pending, and are being considered on their merits. No claims are withdrawn from consideration at this time. References not included with this Office action can be found in a prior action. The instant amendments have overcome the 35 U.S.C. § 112(b) rejections of record, which are withdrawn.
Any other rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
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 11-26 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 collagenase purity limitations of claim 11, 24, and 25, 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 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 and comprise less than 1U of clostripain per mg of total collagenase (¶0360 and Table A, and Table 8).
Regarding the product-by-process limitations of claims 11-20 and 26, 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.
Regarding claims 11 and 21-23, adding 10 mM Tris and 60 mM sucrose at a pH = 8 is routine and conventional over Sabatino at ¶0415.
For the reasons above, claims 11-26 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 11-26 are rejected under pre-AIA 35 U.S.C. 102 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) and comprise less than 1U of clostripain per mg of total collagenase (¶0360 and Table A, and Table 8), the composition comprising 10 mM Tris and 60 mM sucrose at a pH = 8 (¶0415), and 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- and 21-26.
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 and 26 depend from claim 11 and recite 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 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) and comprise less than 1U of clostripain per mg of total collagenase, and the composition comprising 10 mM Tris and 60 mM sucrose at a pH = 8. Particularly, if the product-by process limitations of claims 11-20 and 26 impart no structural difference then the claims are anticipated. If the product-by process limitations of claims 11-20 and 26 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.
Response to Arguments
Applicant's arguments on pages 5-7 of the reply have been fully considered, but not found persuasive of error. All of Applicant’s arguments allege that the instant claim amendments have overcome the 35 U.S.C. § 101 and alternate 102/103 rejections of record. In addition to the modified grounds of rejection set forth above necessitated by the instant claim amendments, the arguments are not persuasive because:
1) there is no showing of any markedly different characteristic(s) at this time for the claimed enzymes nor do the claims recite any additional element that is not routine and conventional under 35 U.S.C. § 101, and
2) Applicant has not yet shown by any preponderance of evidence that the product-by-process limitations impart any novel or nonobvious structure to the claimed enzymes as compared to the substantially identical collagenase I and II composition taught by Sabatino for the alternate 35 U.S.C. § 102/103 rejections. Applicant relies entirely on the product-by-process limitations, without clearly setting forth in the record what impact said process limitations have (if at all) on the claimed product. Patentability of product-by-process claims is based on the product itself, see M.P.E.P. § 2113(I), and Applicant is claiming a composition comprising the collagenases and so the broadest reasonable interpretation of claim 11 does not include any glucose-free culture medium as alleged on pages 5-6 of the reply.
In response to applicant's argument on pages 6-7 of the reply that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., no residual leupeptin) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). However, even if the claims were amended accordingly, Sabatino teaches a composition that further comprises less than 1% μg/mg (w/w) of leupeptin at claim 6. It is not immediately clear at this time how such an amendment would otherwise advance prosecution over Sabatino.
Conclusion
No claims are allowed. No claims are free of the art.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 7:30am-3:30pm EDT/EST (M-F).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at 571-272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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