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 .
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 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.
DETAILED ACTION
Information Disclosure Statement
The information disclosure statements (IDS’s) submitted on 06/11/2025 and 07/01/2025 were filed after the mailing date of the non-final rejection on 03/20/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of claims
The amendment filed on 06/13/2025 is acknowledged. Claims 1-3 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments and arguments filed on 06/13/2025 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn. Applicant’s amendments have overcome the claim objection of claim 1 and 35 U.S.C. 102(a)(1) rejection of claims 1 and 2 over Miyamoto et al. (US 2018/0221268 A1) from the previous Office Action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Rejections maintained
The following rejections of the claims are remained for reasons of record and the following. the rejections are modified based on the amendments.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims under 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 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 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.
Claims 1-3 are rejected under 35 U.S.C. 103(a) as being unpatentable over Miyamoto et al. (US 2018/0221268 A1).
Miyamoto et al. teach (abstract) a composition comprising
0.2-2 mass % of a copolymer based on 2-(meth)acryloyloxyethyl phosphorylcholine (MPC) as a biofilm formation-preventing agent with a molecular weight (MW) of 820,000 and 200,000 (paragraph 117-118 and 120-121);
a disinfectant including chlorhexidine hydrochloride (paragraph 76);
0.05-2 mass % of surfactant including a polyoxyethylene hydrogenated castor oil (non-aromatic, non-cyclic, and thus aliphatic, the claimed polyoxyethylene aliphatic acid ester-based nonionic surfactant) (paragraph 96); and
5-20 mass % solvent including ethanol (paragraph 100).
Miyamoto et al. do not teach a combination of a MPC copolymer with a MW of 820,000 and a MPC copolymer with a MW of 200,000.
The deficiency is cured by the rationale that it is generally considered to be prime facie obvious to substitute compounds each of which is taught by the prior art to be useful for the same purpose in order to form a composition that is to be used for an identical purpose.
It would have been prime facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to modify the composition taught by Miyamoto et al. and to add an additional MPC copolymer. It is generally considered to be prime facie obvious to substitute compounds each of which is taught by the prior art to be useful for the same purpose in order to form a composition that is to be used for an identical purpose. Both a MPC copolymer with a MW of 820,000 and a MPC copolymer with a MW of 200,000 taught by Miyamoto et al. have the same function of preventing biofilm formation is well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for adding an additional MPC copolymer, i.e., a combination of a MPC copolymer with a MW of 820,000 and a MPC copolymer with a MW of 200,000, flows from their having been used individually in the prior art, from their belonging to same category, and from them being recognized in the prior art as useful for the same purpose. In re Kerkhoven, 626 F.2d 848, 205 USPQ 1069 (CCPA 1980). Furthermore, one of the MPC copolymer was claimed (dated 07/28/2022) and is disclosed in the instant specification as being suitable and thus the criticality of the now claimed a combination of two MPC copolymers with different MW over one MPC copolymer is not established.
Although MW of 820,000 is not the not the same as the now claimed 900,000-1,600,000, 820,000 is very close to the now claimed 900,000. A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Furthermore; MPC copolymer with a MW of 800,000-1,800,000 was claimed (dated 07/28/2022) and is disclosed in the instant specification as being suitable and thus the criticality of the now claimed MPC copolymer with a MW of 900,000-1,600,000 over a MPC copolymer with a MW of 820,000 is not established.
Miyamoto et al. do not teach the same weight percentage of lower alcohol (5-20% vs the claimed 20-40%).
This deficiency is cured by the rationale that a prima facie case of obviousness typically exists when the range of a claimed composition lies inside the range disclosed in the prior art, such as in the instant rejection.
The claimed range of lower alcohol is 20-40% by weight and the range of lower alcohol taught in the prior art is 5-20% by weight and therefor, overlaps with the claimed range. Furthermore, 5-90% of lower alcohol was claimed (dated 07/28/2022) and is disclosed in the instant specification as being suitable and thus the criticality of the now claimed 20-40% 5-20% by weight over 5-20% by weight 5-20% by weight is not established.
Miyamoto et al. do not specify the weight percentage of the disinfectant (the instant claim 3).
This deficiency is cured by Miyamoto et al.’s teachings of 0.05% by weight of chlorhexidine hydrochloride in examples 1-20 and 1-24.
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in paragraph 76 and examples 1-20 and 1-24 in Miyamoto et al. to specify the weight percentage of the disinfectant in the composition taught by Miyamoto et al. being 0.05 mass %. Incorporating 0.05 mass % of chlorhexidine hydrochloride disinfectant was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Response to Applicants’ arguments:
Applicant’s arguments based on the amendments are addressed in the modified rejection above (underlined).
Applicants argue that the surfactant taught by Miyamoto et al. is optional.
However, this argument is not deemed persuasive. A surfactant including polyoxyethylene hydrogenated castor oil is taught by Miyamoto et al., whether it is optional or not.
Applicants argue that comparative example 2 and 3 in the instant specification demonstrated MPC copolymer with a MW of 600,000 having inferior foam sustainability.
However, this argument is not deemed persuasive. It does appear that there are unexpected results, however, the scope of the coemption in the claims is much broader than the those of the compositions in the experiment with regard to the specific MPC copolymer and its specific MW vs the claimed combination of MPC copolymers, the specific lower alcohol, the specific surfactant, and their specific weight percentages. There is no adequate basis for reasonably concluding that the great number and variety of compositions included by the claims would behave in the same manner as the single tested composition. In other words, Applicant has not shown that based on this single example, it is reasonable to expect that other embodiments falling within the scope of the claims will behave similarly. Please refer to MPEP 716.02(b) III:
Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) and MPEP § 716.02(d) - § 716.02(e). See In re Blondel, 499 F.2d 1311, 1317, 182 USPQ 294, 298 (CCPA 1974) and In re Fouche, 439 F.2d 1237, 1241-42, 169 USPQ 429, 433 (CCPA 1971) for examples of cases where indirect comparative testing was found sufficient to rebut a prima facie case of obviousness.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-3 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 7,824,665 B2; claims 1-14 of U.S. Patent No. 10,195,131 B2; claims 1-5 of U.S. Patent No. 10,376,848 B2; and claims 1-14 of U.S. Patent No. 10,829,710 B2 in view of Miyamoto et al. (US 2018/0221268 A1).
The subject matter claimed in the instant application is fully disclosed in the patent and is covered by the patent since the patent and the application are claiming common subject matter, as follows:
The instant application claims 1-3 recite a disinfecting composition containing 0.001-5 mass % of a 2-(meth)acryloyloxyethyl phosphorylcholine (MPC) copolymer with a weight average molecular weight (Mw) of 10,000-400,000 or 800,000-1,800,000, 5-90 mass % of a lower alcohol, and 0.01-10 mass % of an aliphatic acid ester-based nonionic surfactant.
The US 7,824,665 B2 patent claims 1-12 recite a disinfectant gel for hands comprising 40-95 wt % of a lower alcohol, 0.001-10 wt % of a MPC polymer, and 4-55 wt % of water.
The US 10,195,131 B2 patent claims 1-14 recite an oral composition comprising a phosphorylcholine-containing polymer MPC with a Mw of 10,000-10,000,000.
The US 10,376,848 B2 patent claims 1-5 recite a fouling inhibitor comprising a MPC copolymer having a Mw of 10,000-300,000.
The US 10,829,710 B2 patent claims 1-14 recite an article comprising a crosslinked body of a copolymer having a Mw of 10,000-1,000,000 containing a 2-methacryloyloxyethyl phosphorylcholine unit.
The US 10,195,131 B2 patent claims 1-14 do not claim a lower alcohol and an aliphatic acid ester-based nonionic surfactant; the US 7,824,665 B2 patent claims 1-12 do not claim an aliphatic acid ester-based nonionic surfactant, the US 10,376,848 B2 patent claims 1-5 do not claim a lower alcohol and an aliphatic acid ester-based nonionic surfactant; and the US 10,829,710 B2 patent claims 1-14 do not claim a lower alcohol and an aliphatic acid ester-based nonionic surfactant.
This deficiency is cured by Miyamoto et al. whose teachings are discussed above and applied in the same manner.
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Miyamoto et al. and the recitation in the US 10,195,131 B2 patent claims 1-14, the US 7,824,665 B2 patent claims 1-12, the US 10,376,848 B2 patent claims 1-5, and the US 10,829,710 B2 patent claims 1-14 to add a lower alcohol and an aliphatic acid ester-based nonionic surfactant to the US 10,195,131 B2 patent claims 1-14; to add polyoxyethylene hydrogenated castor oil nonionic surfactant to the US 7,824,665 B2 patent claims 1-12, to add a lower alcohol and a polyoxyethylene hydrogenated castor oil nonionic surfactant to the US 10,376,848 B2 patent claims 1-5; and to add a lower alcohol and polyoxyethylene hydrogenated castor oil nonionic surfactant to the US 10,829,710 B2 patent claims 1-14. Incorporating a lower alcohol and an aliphatic acid ester-based nonionic surfactant in a composition comprising a MPC copolymer was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Although the patent and instant claims are not identical, they are not patentably distinct from each other because claims in both applications are drawn to the same composition.
Claims 1-3 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 9-21 of copending Application No. 18/039,567 in view of Miyamoto et al. (US 2018/0221268 A1). Although the patent and instant claims are not identical, they are not patentably distinct from each other because: the instant claims 1-3 are discussed above and applied in the same manner.
The 18/039,567 application claims 9-21 recite a MPC copolymer.
The 18/039,567 application does not claim a lower alcohol and an aliphatic acid ester-based nonionic surfactant.
This deficiency is cured by Miyamoto et al. whose teachings are discussed above and applied in the same manner.
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Miyamoto et al. and the recitation in the 18/039,567 claims 9-21 to add a lower alcohol and polyoxyethylene hydrogenated castor oil nonionic surfactant. Incorporating a lower alcohol and polyoxyethylene hydrogenated castor oil nonionic surfactant in a composition comprising a MPC copolymer was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Although the patent and instant claims are not identical, they are not patentably distinct from each other because claims in both applications are drawn to the same composition.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Response to Applicants’ arguments:
Applicant’s arguments based on the amendments are addressed in the modified rejection above (underlined).
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 extension fee 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 HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG YU/
Primary Examiner, Art Unit 1614