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 .
DETAILED ACTION
Claims 1 and 11-25 are currently pending and the claims as originally filed on 07/24/2026 are acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/24/2026 was filed before the mailing date of the instant action on the merits. The submissions thereof are in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statement has been considered by the examiner, and signed and initialed copy is enclosed herewith.
New Grounds of Objection/Rejections --- as necessitated by amendment
Claim Objections
Claim 21 is objected to a minor informality under 37 CFR 1.75.
Claim 21 recites “added salt” in line 2, but which would be better to recite “the added salt”. Appropriate correction is requested.
Claim Rejections - 35 USC § 112
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.
Claims 1 and 11-14 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.
Claim 1 recites claim 1 recites “a solution” in line 7, but which lacks an antecedent basis because this “solution” is a new element. Applicant may consider amending “An oral care solution composition comprising …. wherein the solution … a pH range of about 4.5 to about 9.”
Further, claim 1 recites “the one or more surfactant”, but which also lacks sufficient antecedent basis because claim 1 requires at least two surfactants, i.e., main surfactant and co-surfactant. Claim 13 reciting “the one or more surfactants” has the same issue.
Appropriate correction is requested.
The remaining claims are also rejected due to the rejection of base claim 1.
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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 15-25 are rejected under 35 U.S.C. 103 as being unpatentable over St. John et al. (US2022/0096364A1, IDS of 11/07/2024).
Applicant claims the below claim 15 filed on 07/24/2026:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical oral care composition research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from oral care medicine, pharmacy, physiology and chemistry— without being told to do so. In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness
Regarding instant claims 15, 20, 21 and 23-25, St. John discloses that an oral care composition comprising prenylated flavonoid that is extracted from hops extract ([0056]), i.e., hops beta acid having higher antibacterial and/or anticaries activity in an amount of about 2 to about 12% ([0032]-[0038]), one or more surfactant including SLS, lauryl glucoside, sodium cocoyl glutamate, poloxamer, etc. ([0118]-[0126]), flavoring agent (e.g., [0138]) and buffering agent such as citric acid and sodium citrate in an amount of about 0.1 to about 30% ([0078]) which reads on the claimed added salt and the amount overlaps the instant range of at least 2.5% or at least 3%; the composition has a pH of about 4 to about 10 ([0106]) which overlaps the instant pH range of about 5 to about 7.5 of instant claim 15; and the composition further thickening agent to provide a gelatinous structure that stabilizers the dentifrice and/or toothpaste against phase separation ([0130]) which reads on the claimed phase stability (instant claims 15, 20 and 23); the oral care composition can be dentifrice ([0027])(instant claim 24); and the composition further comprises flavoring agent such as wintergreen oil, peppermint or spearmint oil ([0138]) (instant claim 25).
Regarding instant claims 16-19 and 22, St. John discloses one or more surfactant includes one or more surfactants including sodium lauryl sulfate (SLS) , sodium methyl acyl taurate, coco-betaine (=cocamidopropyl betaine), poloxamer, sodium cocoyl glutamate, lauryl glucoside … combinations thereof (e.g., [0119], [0122], [0123], [0125], [0126]) (instant claims 16-17); St. John does not expressly disclose the surfactant is free of poloxamer, and however, non-selecting poloxamer surfactant would be a matter of choice or design when preparing the composition because any other equivalent surfactant can be used from the standpoint of the ordinary artisan (instant claim 18); and St. John remains silent about polysorbate 80 as a surfactant (instant claim 19); and St. John teaches one or more metal ion source from Sn, Zn, Cu, Mn, Mg, Sr, Ti, Fe, Mo, B, Ba, Ce, Al, In and/or mixtures thereof ([0083]) and thus it would have been obvious to take Ti instead of Zn salt as a matter of choice or design (instant claim 22).
Although St. John does not expressly teach weight ratio of added salt to water of instant claim 21, this prior art teaches the composition has water in an amount from 0% to about 99% ([0098]) and the added salt e.g., sodium citrate in an amount of about 0.1 to about 30% ([0078]). Thus, the ordinary artisan would have optimized the ratio of added salt to water with the claimed ratio without undue experimentation, in the absence of criticality evidence of the claimed range (instant claim 21).
In light of the foregoing, instant claims 15-25 are obvious over St. John.
Response to Arguments
Applicant’s arguments have been fully considered, but are not persuasive because Applicant’s arguments based on OD600, combination of two surfactants, and alleged unexpected results are focused on the invention of instant claim 1, not of instant claim 15.
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 claims at issue 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 reference 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. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 15-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8, 16 and 17 of patent no. 11,690,792B2 in view of St. John (US2022/0096364A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims set require hops acid including non-hydrogenated hops beta acid, metal ion including tin and zinc, buffering agent such as added salt, and overlapping pH.
However, the claims of patent ‘792 do not expressly teach one or more surfactant and their species. The deficiencies are cured by St. John teaches one or more surfactants. It would have been obvious to modify the claims of patent ‘792 with addition of surfactants in order to enhance the properties of oral care composition.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘792 subject matter.
Claims 15-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7, 9-11, 13 and 14 of patent no. 11,918,681B2 in view of St. John (US2022/0096364A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims set require hops acid including non-hydrogenated hops beta acid, metal ion tin, buffering agent and overlapping pH.
However, the claims of patent ‘681 do not expressly teach one or more surfactant and their species. The deficiencies are cured by St. John disclosing one or more surfactants. It would have been obvious to modify the claims of patent ‘681 with addition of surfactants in order to enhance the properties of oral care composition.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patent ‘681 subject matter.
Claims 15-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12 and 13-17 of copending application no. 18/884510 in view of St. John (US2022/0096364A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims set require hops acid including hops beta acid, metal ion including tin (=stannous ion) and overlapping amounts thereof.
However, the claims of copending ‘510 do not expressly teach one or more surfactant and their species. The deficiencies are cured by St. John disclosing one or more surfactants. It would have been obvious to modify the claims of copending ‘510 with addition of surfactants in order to enhance the properties of oral care composition.
Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending ‘510 subject matter.
This is a provisional double patenting rejection since the conflicting claims have not yet been patented.
Conclusion
All claims examined are rejected.
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 KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/ Primary Examiner, Art Unit 1613
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