DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after September 14, 2023, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
Receipt is acknowledged of Applicants’ claimed invention filed on 09/14/2023 in the matter of Application N° 18/368,373. Said documents are entered on the record. The Examiner further acknowledges the following:
Status of Claims
Claims 1-3, 5-7, 9-11, 14, and 18-25 represent all claims currently under consideration.
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.
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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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 1-3, 5-7, 9-11, 14, and 18-25 rejected under 35 U.S.C. 103 as being unpatentable over Hinrichs et al. (WO2017116444A1), in view of Axe et al. (WO2010112577).
Regarding claims 1, 6, 21, 23, and 25, Hinrichs et al. teach oral care compositions comprising cationic surfactants, amine base and amine fluoride (See paragraph 0034 and 0036). useful in the present disclosure such as the ammonium cation surfactants; A zinc source chosen from zinc chloride, zinc citrate, zinc acetate, zinc sulfate, and a zinc source (See paragraph 0065 and 0040). Hinrichs et al. teach dentifrice compositions with superior antibacterial properties (See paragraph 0001 and 0004). The following composition is taught by Hinrichs et al. (See paragraph 0076, Table 2). There is no zinc source in Hinrich’s compositions 1 or 2. Zinc salts, like zinc citrate, can be added to its composition as an odor-neutralizing agent, according to Hinrichs. The compositions are free of stannous fluoride. Therefore, using zinc citrate in the compositions above with a reasonable expectation of neutralizing odor would have been obvious to one skilled in the art.
With regards to the instant claim 6, the concentration of the amine base has 0.72 weight percent (See table 2). Hinrichs et al. teach 1.84 weight percent amine fluoride. There is no zinc source in Hinrichs et al. compositions 1 or 2. Zinc salts, like zinc citrate, can be added to its composition as an odor-neutralizing agent. a recognized result and, therefore, the determination of the optimum or workable dosage range would have been well within the practice of routine experimentation by the skilled artisan, absent factual evidence to the contrary.
Thus, Hinrichs et al. makes instant claims 1, 6, and 10 obvious.
Hinrichs et al. further teach that the amine base is meant to represent the base part of amine fluoride (often referred to as “olaflur”), which is N,N,N,-tris (2-hydroxyethyl), with regard to instant claims1, 2, 3, and 5. As the amine base -N-octadecyl-1,3-diamonopropane, which teaches instant linear saturated C12-20 alkyl polyamine base, is another name for instant N-octadecyltrimethylendiamine-N,N,N-tris(2-ethanol) (See paragraph 0034 and 0036).
The amine fluoride found in the above compositions does not impart the instant fluoride source of claim 7, according to instant claim 7. Hinrichs et al. teach that one or more fluoride ion sources, such as sodium fluoride, potassium fluoride, or ammonium fluoride, may also be included in its dentifrice compositions (See paragraph 0033 and 0034).
Regarding instant claim 11, Hinrichs et al. teach at least one alpha-hydroxy acid, like malic acid, may be present in the compositions of immediate claim 11 (See paragraph 0038).
Regarding claim 14, Hinrichs et al. also teach the present specification’s instantly recited states that amine fluoride is formed in a salination reaction carried out by mixing an amine with a fluoride source and an acid, resulting in an amine fluoride and a salt (See paragraph 0012), Hinrichs et al. composition, which consists of an instant amine base, an instant fluoride source, and an instant acid (malic acid).
However, Hinrichs et al. fails to teach the quantity of its zinc salt (zinc citrate),
Axe et al. teach, with regards to instant claim 9, the equivalency or interchangeability of Hinrichs et al. zinc citrate and instant zinc lactate, both of which are zinc salt compounds that can be appropriately used in a composition for combining oral malodor or bad breath (See pg. 6, lines 11-13).
Axe et al. teach that zinc salt compounds, like zinc citrate, can be used in a composition for fighting bad breath or oral malodor in amounts of 0.01-2.50 weight percent, depending on the overall composition (See pg. 6, lines 7-15). Oral care compositions that contain a source of zinc ions are known to combat oral malodor (See pg. 4, lines 4-5). It would have been obvious to a person of ordinary skill in the art to use 0.01-2.50 wt.% of zinc citrate in Hinrich’s composition with a reasonable expectation of combating oral malodor or bad breath, because Hinrich et al. already teach that their composition can include a zinc salt, such as zinc citrate, as an odor neutralizing agent, but without revealing the amount to be used. Immediate ranges are prima facie obvious because the range that Axe et al. teach overlaps with the immediate range (about 0.5-2.0 weight percent) of claim 10. According to In re Wertheim, 541 F.2d 257,191 USPQ 90 (CCPA 1976), there would be a prima facie case of obviousness in the situation “where the claimed range overlap or lie inside ranges disclosed by the prior art,” which might be overcome by a showing of unanticipated results.
Regarding claim, 18, Axe et al. teach oral healthcare products frequently contain antibacterial agents. Cationic pyridinium chloride is frequently included (See pg. 4, paragraph 30). The cationic cetylpyridinium chloride is frequently added (See pg. 3, paragraph 30, As regarded by instant claim 14, and 18).
Regarding claim 18, Axe et al. teach zinc lactate (See pg. 7, line 12).
Regarding claims 19, 22, 24, and 25, Axe et al. teach mouthwashes are the usual type of formulation for the oral mixture of the present invention (See pg.10, paragraph 30).
Hinrichs et al. fail to expressly teach the particular quantity of zinc citrate in the oral composition. However, Axe teaches the equivalency and interchangeability of zinc citrate with zinc lactate, both of which are zinc salt compounds known in the art as effective odor-neutralizing agents for controlling oral malodor or bad breath. While Hinrichs et al. does not disclose the use of zinc lactate, one of ordinary skill in the art would have recognized that zinc lactate is an obvious substitute for zinc citrate because both salts are chemically similar, used in the same technical field (oral care compositions), and provide the same utility of odor neutralization.
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the instant application, to modify the oral composition of Hinrichs et al. by employing zinc lactate in place of zinc citrate, with a reasonable expectation of success, in view of the teachings of Axe. One would have been motivated to combine these references because they are directed to the same field of endeavor, concern the same problem addressed by applicant (oral malodor control), and share common ingredients and utilities, consistent with the reasoning set forth in MPEP2141.01(a).
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 AlA. 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 |.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 1-3, 5-7, 9-11, 14-15, and 17-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18, of copending Application No. 17/632,179 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reason:
Although the copending claims are composition claims overlap composition claims. It would have been obvious to practice using the manufactured oral composition with a reasonable expectation of success in practicing the instant claims. Both sets of oral composition recite a composition comprising an amine base, a fluoride source and a zinc source selected from zinc lactate and zinc citrate, wherein the composition is free of stannous fluoride and contains the zinc source in the amount of 0.1-2.5 wit.%.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 5-7, 9-11, 14-15, and 17-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 17,632,182. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reason:
Both sets of claims recite the same composition and therefore one of ordinary skill in the art would have been motivated to practice the instant claims using the copending claims with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 5-7, 9-11, 14-15, and 17-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of copending Application No. 17/627,852. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reason:
Both sets of claims recite the same composition and therefore one of ordinary skill in the art would have been motivated to practice the instant claims using the copending claims with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed December 18, 2025 have been fully considered but they are not persuasive.
Claims 1-3, 5-7, 9-11, 14, and 18-25 are rejected under 35 U.S.C. 103 as being unpatentable over Hinrichs et al. in view of Axe et al. and further in view of Arvanitidou et al.
The rejection under 35 U.S.C. 112 has been considered in view of applicant’s amendments and arguments and is hereby withdrawn.
The nonstatutory obviousness-type double patenting rejection is maintained.
Applicant has amended claim 1 to recite an oral care composition comprising an amine base, a fluoride source, a zinc source selected from zinc lactate and zinc citrate, and cetylpyridinium chloride in an amount of from about 0.05 wt.% to about 1 wt.% based on the total weight of the composition, wherein the composition is free of stannous fluoride.
Applicant argues that neither Hinrichs et al. nor Axe et al. alone or in combination, teaches or suggests the claimed combination of components. This argument is not persuasive.
Hinrichs et al. disclose oral care compositions comprising cationic surfactants, amine bases, and fluoride sources, including amine fluorides. Hinrichs et al. further teach zinc sources including zinc chloride, zinc citrate, zinc acetate, and zinc sulfate, wherein zinc salts such as zinc citrate are used as odor neutralizing agents. Hinrich’s et al. also disclose compositions that are free of stannous fluoride. Thus, Hinrich’s et al. teach an amine base, a fluoride source, and a zinc source selected from zinc citrate.
Arvanitidou et al. disclose dentifrice compositions comprising cetylpyridinium chloride in amounts of about 0.30 wt.% to about 0.75 wt.%, which falls within the claimed range of about 0.05 wt.% to about 1 wt.%.
Axe et al. are relied upon for additional teachings regarding oral care compositions and the use of known antibacterial agents and formulation components.
It would have been obvious to one of ordinary skill in art at the time of the invention to modify the compositions of Hinrichs et al. to include cetylpyridinium chloride in the amounts taught by Arvanitidou et al. for its known antibacterial properties. One of ordinary skill in the art would have been motivated to combine these teachings because cetylpyridinium chloride is a well-known antibacterial agent in oral care compositions, and its inclusion would have predictably improved antimicrobial efficacy. The selection of zinc citrate as the zinc source would likewise have been obvious for its known odor-neutralizing function. The combination of these known elements according to their established functions would have yielded predictable results with a reasonable expectation of success.
Applicant’s argument regarding the absence of stannous fluoride is not persuasive, as stannous fluoride is only one of many known fluoride sources, and Hinrichs et al. already disclose compositions that do not require stannous fluoride.
Accordingly, the combination of Hinrichs et al., Axe et al., and Arvanitidou et al. renders the claimed invention obvious. Therefore, the rejection under 35 U.S.C. 103 is maintained.
Conclusion
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 Kimberly Barber whose telephone number is (703) 756-5302. The examiner can normally be reached on Monday through Friday from 6:30 AM to 3:30 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax, can be reached at telephone number (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIMBERLY BARBER/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615