DETAILED ACTION
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 .
Election/Restrictions
Applicant's election with traverse of invention group I, claims 1-8, 11-14, in the reply filed on 06/25/2026 is acknowledged. The traversal is on the ground(s) that there is unity of invention after amendment. This is not found persuasive because the restriction requirement is based on the claims before restriction. Furthermore, the prior art also teaches the combination of arginine and phosphate for the treatment of microbial in the following 103 rejections.
The requirement is still deemed proper and is therefore made FINAL.
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/25/2026.
Claims 1-8, 11-20 are pending, claims 1-8, 11-14 are under examination.
Priority
Acknowledge is made that this application is national stage of international patent application PCT/US2021/071937, filed on 10/20/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/05/2024 and 05/21/2025 is being considered by the examiner.
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 of this title, 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.
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 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 1-8 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Pimenta et al. (US20140305461) in view of Souto et al. (“Prevalence of Enterococcus faecalis in subgingival biofilm and saliva of subjects with chronic periodontal infection”, Archives of Oral Biology, Volume 53, Issue 2, February 2008, Pages 155-160).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Pimenta et al. teaches aqueous oral care compositions (abstract). The oral care composition comprises 50-90% of water, 0.01-5% of Sodium phosphate monobasic, 0.01-5% of Disodium phosphate, 0.05-2% of Arginine (in free or salt form, by weight of the free base) and cellulose polymer such as hydroxypropyl methyl cellulose at 0.01-0.5% ([0020, 0023]). The oral care composition is in the form of mouthwash ([0024, 0050, 0062, 0064]). The administering of oral care composition to oral cavity is recited (claim 20).
Souto et al. teaches Enterococcus faecalis is frequently detected in the oral microbiota of periodontitis patients (abstract). In summary, the oral cavity has been shown to be a reservoir for E. faecalis. More importantly, our findings provide additional evidence for the association of this microorganism with the presence of periodontal infection. Considering that eradication of this species from subgingival biofilm in deep periodontal pockets may be limited, close attention should be given to these patients in order to reduce the risk for development of systemic diseases caused by E. faecalis in other areas of the body (page 159, last paragraph).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Pimenta et al. is that Pimenta et al. do not expressly teach suppressing collagenase. This deficiency in Pimenta et al. is cured by the teachings of Souto et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Pimenta et al., as suggested by Souto et al., and produce the instant invention.
Pimenta et al. teaches a mouthwash comprising 0.01-5% of Sodium phosphate monobasic, 0.01-5% of Disodium phosphate, 0.05-2% of Arginine and hydroxypropyl methyl cellulose. Both Sodium phosphate monobasic and Disodium phosphate are considered as phosphate in applicant’s claim 1 because Sodium phosphate monobasic and Disodium phosphate are the same at certain pH (for example pH 7.4). When the aqueous mouthwash has density about 1g/ml, when Sodium phosphate monobasic (MW 120) is at 0.3% by weight, in 1L of mouthwash, the weight of Sodium phosphate monobasic is 0.3% x1000g=3g, 3g/120=0.025 mol=25mM; Disodium phosphate (MW142) is at 0.355% by weight, in 1L of mouthwash, the weight of Disodium phosphate is 0.355%x1000g=3.55g, 3.55g/142=0.025 mol=25mM; when Arginine (MW174.2) is at 0.871%, in 1L of mouthwash, the weight of Arginine is 0.871%x 1000g=8.71g, 8.71g/174.2=0.05mol= 50mM. Thus, Pimenta et al. teaches a mouthwash comprising mouthwash comprising 50mM of arginine and 50mM of phosphate (25 mM of Sodium phosphate monobasic and 25 mM of Disodium phosphate) as well as administering this mouthwash to oral cavity, but Pimenta et al. is silent about suppressing collagenase and Enterococcus faecalis as well as providing a log reduction of microbes of less than 1.
As evidenced by Souto et al. that Enterococcus faecalis is frequently detected in the oral microbiota of periodontitis patients, when periodontitis patients are administered with mouthwash comprising 50mM of arginine and 50mM of phosphate, this process will result in suppressing collagenase (produced by Enterococcus faecalis) and Enterococcus faecalis as well as providing a log reduction of microbes of less than 1. In summary, although the reference is silent about all the functional properties instantly claimed, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same patient is being administered the same mouthwash comprising the same arginine and phosphate by the same mode of administration in the same amount in both the instant claims and the prior art reference. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method. Thus, prior art teaches, either expressly or inherently implied, each and every limitation of the instant claims. it remains the Examiner's position that the instantly claimed method is obvious.
Regarding claims 5-8 and 13, Pimenta et al. teaches mouthwash comprising hydroxypropyl methylcellulose, and solution is common form of mouthwash which is applied to mouth comprising mucosa.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1-8 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Huang (US20180271762) in view of Souto et al. (“Prevalence of Enterococcus faecalis in subgingival biofilm and saliva of subjects with chronic periodontal infection”, Archives of Oral Biology, Volume 53, Issue 2, February 2008, Pages 155-160).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Huang teaches oral care composition comprising arginine (abstract). The composition comprises arginine 0.1% to 6.0% by weight based on free form ([0022-0023]). In one embodiment, arginine is in the form of arginine phosphate ([0038]). The composition comprises cellulose such as hydroxyethyl cellulose ([0165]). The composition is in the form of mouth wash or rinse (claims 1 and 31). The composition inhibits microbial film formation after being applied to mouth (claim 34).
Souto et al. teaching has already been discussed in the above 103 rejection and is incorporated herein by reference.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Huang is that Huang does not expressly teach suppressing collagenase. This deficiency in Hung is cured by the teachings of Souto et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Huang, as suggested by Souto et al., and produce the instant invention.
Huang teaches mouthwash composition comprising arginine phosphate at 0.1% to 6.0% by weight based on free form of arginine. If the density of mouthwash is about 1 g/ml, when Arginine (MW174.2) is at 0.871%, in 1L of mouthwash, the weight of Arginine is 0.871%x 1000g=8.71g, 8.71g/174.2=0.05mol= 50mM; count ion phosphate in arginine phosphate is also 50mM. Thus, Huang teaches a mouthwash comprising mouthwash comprising 50mM of arginine and 50mM of phosphate as well as administering this mouthwash to oral cavity, but Huang is silent about suppressing collagenase and Enterococcus faecalis as well as providing a log reduction of microbes of less than 1.
As evidenced by Souto et al. that Enterococcus faecalis is frequently detected in the oral microbiota of periodontitis patients, when periodontitis patients are administered with mouthwash comprising 50mM of arginine and 50mM of phosphate, this process will result in suppressing collagenase (produced by Enterococcus faecalis) and Enterococcus faecalis as well as providing a log reduction of microbes of less than 1. In summary, although the reference is silent about all the functional properties instantly claimed, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same patient is being administered the same mouthwash comprising the same arginine and phosphate by the same mode of administration in the same amount in both the instant claims and the prior art reference. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method. Thus, prior art teaches, either expressly or inherently implied, each and every limitation of the instant claims. it remains the Examiner's position that the instantly claimed method is obvious.
Regarding claims 5-8 and 13, Huang teaches mouthwash comprising hydroxypropyl methylcellulose, and solution is common form of mouthwash which is applied to mouth comprising mucosa. Huang teaches cellulose encompassing hydroxypropyl methyl cellulose as common cellulose thickener.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
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 and 11-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12399488 in view of Pimenta et al. (US20140305461) and Souto et al. (“Prevalence of Enterococcus faecalis in subgingival biofilm and saliva of subjects with chronic periodontal infection”, Archives of Oral Biology, Volume 53, Issue 2, February 2008, Pages 155-160). The reference patent teaches oral care composition comprising arginine (claim 7) and phosphate (claim 19) for treating biofilm, in view of Pimenta et al. teaching arginine and phosphate each at 50mM, Souto et al. teaching Enterococcus faecalis is frequently detected in the oral microbiota of periodontitis patients, when periodontitis patients are administered with mouthwash comprising 50mM of arginine and 50mM of phosphate, this process will result in suppressing collagenase (produced by Enterococcus faecalis) and Enterococcus faecalis as well as providing a log reduction of microbes of less than 1. Thus, one artisan in the art would immediately recognize the obvious variant of applicant’s claimed invention over patented subject matter.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613
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