DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09 July 2026 has been entered.
Status of Application
The amendments and response filed 09 July 2026 are acknowledged. Claims 1-20 are canceled and claims 21-36 are new and commensurate in scope with the previously examined claims and elected Group.
Withdrawal of Previous Rejections
The rejection of claim(s) 1-7 and 17-20 under 35 U.S.C. 103 as being unpatentable over Gjermansen et al. (WO2017059802 – cited on IDS of 11/04/2022) in view of Coquillat, J. (WO2017129331 – cited on IDS of 11/04/2022) and Ostergaard et al. (US 10781408 – cited previously) is withdrawn in view of the cancelation of said claims.
New Rejection(s)
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.
Claims 32-36 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 recite the limitation "the organic soil" in reference to claim 21. There is insufficient antecedent basis for this limitation in the claim because claim 21 does recite organic soil. It is noted, claim 29 recites “organic soil”.
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.
Claim(s) 21-36 are rejected under 35 U.S.C. 103 as being unpatentable over Coquillat, J. (WO2017129331 – cited on IDS of 11/04/2022) in view of Ostergaard et al. (WO 2019018724 – cited IDS 02/27/2026) and Ye et al. (Mat. Sci. and Eng., 2017 – cited PTO-892 10/27/2025).
Coiquillat teach regarding claim 21-25, 28, a method for cleaning a medical or dental implant instrument comprising soaking the medical or dental instrument in an aqueous composition comprising a protease/subtilisin and rinsing the instrument (See claims 1-2), wherein the pH of said aqueous composition is between 7-10 (See claim 5), and wherein the aqueous composition further comprises a DNase and additional cleaning components (See claims 4-5; p. 7, lines 24-28); see also p. 3, lines 5-36. Although this claim/paragraph describes multiple, alternative types of additional enzymes to be added to the subtilisin aqueous wash composition, DNase is one of only eight alternative embodiments and therefore, one of ordinary skill would have immediately envisaged such a composition. Regarding claims 29-30, 33-36, the method reduces the amount/cleans organic soil from medical devices such as blood, blood constituents, etc. (See claim 15; see also p. 3, lines 5-36) and upto 100% organic soil removal is achieved (See Example 1).
Coiquillat however, do not teach the precise DNase utilized in the medical instrument cleaning wherein the DNase has at least 98% sequence identity to instant SEQ ID NO: 2 nor the specific examples of removal of organic soil from medical instruments which comprise also rinsing, drying and disinfecting the device.
Ostergaard et al. teach methods and compositions for cleaning surfaces to remove biofilms comprising utilizing detergent compositions comprising DNase, wherein the DNase are all derived from Bacillus and wherein the DNase variants have improved washing performance. Specifically, the DNase variants from Bacillus cibi and include those having 100% sequence identity to instant SEQ ID NO: 2 (See Supplemental Content, 20260824_104009_us-17-923-489b-2.rag file, Duplicates of Result #1; and see Claim 5). The cleaning composition comprising said DNase is to be utilized for both laundry/textiles and hard surfaces alike (See p. 1, third paragraph; p. 3, line 35 to p. 4, line 12; claim 23). The cleaning composition comprising said DNase further comprises peracids (e.g. peracetic acid) See p. 177, lines 31-35.
Ye et al. teach a method of treating a simulated medical device, e.g. a titanium plate, by immersing the plate(s) in a composition comprising DNase I in a PBS buffer having a of pH 6.8 for 6 hours. This was followed by rinsing, drying and storing the plates. In addition, the instant specification defines “wash liquor” at paragraph 0037 (PG-Pub) as “a solution or mixture of water and a cleaning composition.”; and a “cleaning composition” is defined as: “refers to compositions that find use in the removal of undesired compounds from items to be cleaned, such as medical devices. The terms encompass any materials/compounds selected for the particular type of cleaning composition desired and the form of the product (e.g., liquid, gel, powder, granulate, paste, or spray compositions).” The DNase I composition of Ye et al. meets both of these definitions. The titanium plate was disinfected by ultrasonication in acetone, ethanol and deionized water prior to the wash step.
Therefore it would have been obvious to one of ordinary skill in the art at the time to utilize DNase’s for their intended purpose of medical cleaning compositions as taught by Coiquillat, Ostergaard and Ye et al. and to specifically utilize those derived from Bacillus having 100% identity to instant SEQ ID NO: 2 because Ostergaard et al. teach they possess improved wash performance (See p. 7, lines 12-23 and Examples). This would be motivation in and of itself. One skilled in the art would have a reasonable expectation of success in utilizing the DNase of Ostergaard and having 100% sequence identity to instant sEQ ID NO: 2 in the method of Coiquillat because Coiquillat, Ostergaard and Ye all utilize DNase’s for the exact same purpose.
Conclusion
No claim is allowed.
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 24 August 2026
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