DETAILED ACTION
Notice of 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
Applicant's election with traverse of Group I, claims 1-8, in the reply filed on 18 August 2025 is acknowledged. The traversal is on the ground(s) that at least for Group I and II, 37 C.F.R. 1.475(b) states unity of invention exists if the claims are drawn to one of five categories including part (b) product and process of use of said product and that no objection to unity of invention was found by the ISA. This is not found persuasive because Applicant’s have not challenged the finding for breaking unity of invention based on the prior art cited. Said prior art can be utilized for breaking unity of invention for the special technical feature that does unify products and process of use of said products but as noted, Applicant’s have not challenged the cited art (See MPEP 1850 and 1893). With regard to Applicant’s arguments that “Significantly, no objection to unity of invention was raised at any point of the PCT phase.”, this is not convincing as this has no bearing on prosecution/lack of unity findings in national stage applications. MPEP 1893.03(d) stipulates: “The examiner may make a lack of unity requirement in a national stage application even if no such requirement was made by the ISA or IPEA.”
The requirement is deemed proper and therefore made Final.
Status of Application
Claims 1-13 and 15-16 are pending; Claims 9-13 and 15-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Thus, claims 1-8 are subject to examination on the merits.
Priority
The instant application is a 371 of PCT/EP2021/061988 filed 06 May 2021 which claims benefit of foreign priority document EP 20173450.6 filed 07 May 2020 is acknowledged. Said document has been received.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 29 January 2025, 26 November 2024 and 04 November 2022 have been considered by the examiner. See initialed and signed PTO/SB/08’s.
It is noted, three of the FOR references cited on the IDS from 26 November 2024 have not been considered as no English translation of at least the Abstract is provided (or references to an English equivalent).
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.
Claim 5 is 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.
Claim 5 recites the limitation "the organic soil" in reference to claim 1. There is insufficient antecedent basis for this limitation in the claim because claim 1 does not recite any organic soil (rather claim 2 does).
Claim 6 is 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.
Regarding claim 6, the phrases: “preferably”, “more preferably”, “even more preferably”, “most preferably” and "such as", all render the claim indefinite because it is unclear whether the limitations following the phrases are part of the claimed invention. See MPEP § 2173.05(d).
Claim 6 is 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 claim recites that method comprises a step “as measured in Example 2”. The claims are to be complete in themselves. Incorporation by reference to a particular method step as carried out in an Example does not make the claim complete. Similar to the indefiniteness of referencing Tables of Figures in a claim, the reference of said method as “in Example 2” here clearly is for Applicant’s convenience, rather than a necessity. (See 2173.05(s)).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 6-7 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Coquillat, J. (WO2017129331 – cited on IDS of 11/04/2022).
Coquillat teaches:
Regarding claim 1, 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 (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 (See claim 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 and, as such, the disclosure of Coquillat is taken as anticipatory over the claimed invention (See MPEP 2131.02(III)).
Regarding claims 2-3, 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).
Regarding claim 6, up to 100% organic soil removal is achieved (See Example 1).
Regarding claim 7, the DNase is preferably bacterial in origin, more preferably from Bacillus (See p. 13, lines 6-12).
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) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Coquillat, J. (WO2017129331 – cited on IDS of 11/04/2022) as applied to claims 1-3 and 6-7 above, and further in view of Gjermansen et al. (WO2017059802 – cited on IDS of 11/04/2022).
The teachings of Coquillat are recited above and incorporated in its entirety into the instant rejection.
Coiquillat do not, however, teach the precise DNase enzymes which are utilized in the cleaning composition for removing organic soil from medical devices.
Gjermansen et al. teach that biofilms can form on many surfaces including medical devices, teeth, ships and textiles (See p. 1, lines 14-35). They teach utilizing DNase formulations in methods of preventing, reducing or removing biofilms from the surfaces of items (See p. 5, lines 30-31).
The DNase can comprise SEQ ID NO: 21, which has 100% sequence identity to instant SEQ ID NO: 1 (Bacillus cibi; See p. 3, lines 4-10; and Supplemental Content, 20250825_121544_us-17-923-489b-1.rag, Result #1); or the DNase comprises SEQ ID NO: 122, which has 95% sequence identity with instant SEQ ID NO: 10 (See p. 3, lines 26-29; and Supplemental Content, 20250825_121544_us-17-923-489b-10.rag, Result #4). Although this paragraph describes multiple, alternative types of DNase enzymes, they are one of only a select number of alternative embodiments all having 98% sequence identity or more to one another, and therefore, one of ordinary skill would have immediately envisaged such a composition comprising the highly similar DNase enzymes, as such, the disclosure of Gjermansen et al. is taken as anticipatory over the claimed invention (See MPEP 2131.02(III)).
Furthermore, on p. 166, line 31 to p. 167, line 15, it is stated that DNase pharmaceutical formulations can be utilized to remove biofilms from medical devices, wherein said DNase comprise any of SEQ ID NOs: 8-11, which are DNase all derived from Bacillus species.
SEQ ID NO: 8 has 84.8% sequence identity to instant SEQ ID NO: 1; 77.9% identity to instant SEQ ID NO: 2; SEQ ID NO: 9 has 80.3% identity to instant SEQ ID NO: 1 and 76% identity to instant SEQ ID NO: 2; SEQ ID NO: 11 has 80.2% identity to instant SEQ ID NO 1 and 77.5% identity to instant SEQ ID NO: 2 – See SCORE, .rag files, dated 10/23/2025.
Specifically, SEQ ID NOs: 8-11 are utilized in the biofilm removal examples (See Examples 2-4).
Therefore it would have been obvious to one of ordinary skill in the art at the time to utilize the DNase’s taught by Gjermansen et al. which are mainly derived from Bacillus species, including SEQ ID NO: 8-11 and 21 (having between 76% to 100% sequence identity with instant SEQ ID NO: 1, a little low compared to SEQ ID NO: 2), and to utilize the DNase in the medical device cleaning method of Coiquillat because Coiquillat teaches to utilize Bacillus derived DNase. One skilled in the art would be motivated to add the DNase from Gjermansen et al., especially any of SEQ ID NO: 8-11, 21 because they specifically stipulate that these DNase can be used to remove biofilm/organic soil from medical devices (p. 166, line 31 to p. 167, line 15), which is also the goal of Coiquillat. One skilled in the art would have a reasonable expectation of success in adding the DNase from Gjermansen et al. to the formulations and methods of Coiquillat because each teach the required formulations and the methods of cleaning.
Claim(s) 1 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Ye et al., (Mat. Sci. and Eng., 2017 – cited herein).
Ye et al. teach:
Regarding claim 1, 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.
It is noted, the claims do not require that medical device have any sort of contamination/organic soil on them. 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.
Regarding claim 4, the titanium plate was disinfected by ultrasonication in acetone, ethanol and deionized water prior to the wash step.
Ye et al., however, do not teach subjecting a medical device per se to the steps of immersing it with the DNase I, pH 6.8 composition.
Nonetheless, Ye et al. specifically state the whole intention of their trials with titanium plates is to simulate medical implants (See first and last line of Abstract, Introduction and last line of Conclusion). Given the success demonstrated for cleaning/coating/preventing biofilm formation with the DNase I, pH 6.8 composition, it would therefore have been obvious to one of ordinary skill prior to the effective filing date of the claimed invention to utilize the method with medical implants/devices as suggested. The instant application at paragraph 0108 (PG-Pub) includes multiple implants which are considered as a medical device. One skilled in the art would be motivated to treat medical implants as suggested by Ye et al. with their method because as they acknowledge, biofilm formation is a huge source of infections for patients (See Introduction). One skilled in the are would have a reasonable expectation of success in using the methods of Ye et al. on medical implants, at least titanium medical implants, because of the detailed methods provide and the success achieved.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 12-19 of copending Application No. 18728035 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘035 application render obvious the instant claims.
The instant claims in their broadest are drawn to a method for cleaning a medical device comprising the steps of providing a wash liquor having a pH between 6.0-10.0, wherein said wash liquor comprises a polypeptide having DNase activity, and subjecting at least part of the medical device to the wash liquor; optionally rinsing, drying and/or packaging the device. Dependent claims further stipulate what specific DNase enzymes are, such as SEQ ID NOs: 1-10.
The claims to the ‘035 application in their broadest are drawn to methods of cleaning a medical device comprising the steps of: (a) contacting the medical device with a wash liquor comprising two or more enzymes selected from the group consisting of a protease, an enzyme having DNase activity and an enzyme having hexosaminidase activity; and optionally (b) rinsing the medical device. Dependent claim 4 recites the specific DNase is selected from SEQ ID NOs: 1-4.
Instant SEQ ID NO: 1 and SEQ ID NO: 4 from the ‘035 application have 100% sequence identity to one another (See Supplemental Content, 20250825_121544_us-17-923-489b-1.rapm file, Duplicates for Result #1).
Thus, the difference between the two sets of claims, thus is the recitation of the specific pH of the wash liquor as recited in the instant claims; and the inclusion of additional enzymes in the ‘035 application claims. Regarding the later, the instant claims are open and comprising and thus additional elements are permissible. Regarding the former and the pH of the wash liquor, in construing the scope of the application claims consistent with the specification, it is clear the wash liquor has a pH of 8.7 (See paragraphs 0047, 0380-0381, 0405), which is within the range of the instant claims wash liquor pH. As such, the claims to the ‘035 application render obvious the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 23 October 2025