DETAILED ACTION
Applicants' arguments, filed 05/04/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
Priority
The instant application claims foreign priority to JP2020-122198 filed 07/16/2020. The instant application is a 371 of PCT/JP2021/026617 filed 07/15/2021.
Claim Interpretation
The instant application defines a semi-solid as “In the oral care agent of the present invention, the term "semi-solid" means that the oral care agent has an intermediate property between liquid and solid and can maintain a constant shape like a solid, and at the same time, is viscous and freely deformable like a liquid. In the oral care agent of the present invention, the term "semi-solid" may mean, for example, a state of having thixotropic and rheological properties, and of being changeable to a high viscosity state (gel) and a low viscosity state (sol). More specifically, the "semi-solid" in the oral care agent of the present invention means preferably, for example, a state of being capable of applying to the oral cavity and remaining on the applied surface without flowing down therefrom as it is. In the prevention, the "semi-solid "may be, for example, a gel form or a state similar to an ointment, a toothpaste, or the like. The viscous property of the "semi-solid" in the oral care agent of the present invention can be expressed, for example, in viscosity, which is the degree of viscous property of the fluid. The first oral care agent of the present invention is semi-solid as described above, and the viscosity thereof is not particularly limited.” (Instant specification at [0015]). As such, the Examiner is interpreting a gel, ointment or toothpaste as a semi-solid.
With regards to the limitation “,wherein the semi-solid oral care agent is configured to be applied onto the oral deposit adhered in the oral cavity of a subject so as to soften the oral deposit” the term “so as to soften the oral deposit” is interpreted as an intended use of the composition that does not result in a structural difference in the composition and therefore does not further limit the claim.
With regards to instant claim 24, the claim recites “The oral care agent according to claim 1, wherein the oral deposit adhered in the oral cavity of a subject is softened while the oral care agent is being applied onto the oral deposit.” the term “so as to soften the oral deposit” is interpreted as an intended use of the composition that does not result in a structural difference in the composition and therefore does not further limit the claim.
With regards to instant claim 25, the claim recites “The oral care agent according to claim 1, wherein the oral deposit adhered in the oral cavity of a subject is softened while the oral care agent is applied onto the oral deposit so that the oral deposit is removed without damaging the oral surface.” Which is interpreted as an intended use of the composition that does not result in a structural difference in the composition and therefore does not further limit the claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 24 and 25 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 24 and 25 depend from claim 1. Claims 24 and 25 are intended use and do not further limit the claim from which they depend. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1,9, 11, and 13-25 are rejected under 35 U.S.C. 103 as being unpatentable over Mongtomery (US Patent Application Publication 20050026107 A1) in view of Takamori et al (JP2017109978A).
Mongtomery recites a liquid oral therapeutic dental composition, that increases in viscosity upon contact with moisture following application to an oral cavity surface, comprising: a moisture responsive gel carrier comprising a moisture sensitive polymer complex and a water-soluble salt; and a therapeutic agent dispersed in the responsive gel carrier (Mongtomery at claim 1). Mongtomery recites wherein the moisture responsive gel carrier further comprises a thermally responsive polymer (Mongtomery at claim 2). Mongtomery recites wherein the moisture responsive gel carrier further comprises a pH or ion responsive polymer (Mongtomery at claim 3). Mongtomery recites wherein the therapeutic agent is selected from the group consisting of antimicrobial agents, tooth whiteners, anti-inflammatory agents, tooth desensitizers, anticaries agents, tartar control agents, tooth and gum surface protectants, tooth stain prevention agents and agents effective against dental plaque, halitosis, gingivitis, periodontal disease, oral ulcers and other diseases, afflictions or symptoms of the oral cavity (Mongtomery at claim 4). Mongtomery recites wherein the therapeutic agent comprises a tooth whitener (Mongtomery at claim 5). Mongtomery recites wherein the tooth whitener is selected from the group consisting of an alkali metal percarbonate, carbomide peroxide, sodium perborate, potassium persulfate, calcium peroxide, zinc peroxide, chlorine dioxide, sodium chlorite, a hydrogen peroxide complex, hydrogen peroxide and mixtures of any of the foregoing (Mongtomery at claim 6). Mongtomery recites wherein the tooth whitener comprises about 0.01% (w/w) to about 20.0% (w/w) of hydrogen peroxide (Mongtomery at claim 7). Mongtomery recites wherein the tooth whitener comprises about 2.0% (w/w) to about 30.0% (w/w) of carbamide peroxide (Mongtomery at claim 9). Mongtomery recites wherein the moisture responsive gel carrier comprises from about 80.0% (w/w) to about 99.99% (w/w) of the composition (Mongtomery at claim 10). Mongtomery recites wherein the moisture sensitive polymer complex comprises carboxypolymethylene and polyvinylpyrrolidone (Mongtomery at claim 11). Mongtomery recites wherein the water soluble salt is selected from the group consisting of sodium saccharin, sodium chloride, potassium chloride, and ammonium chloride (Mongtomery at claim 12). Mongtomery recites wherein the temperature sensitive polymer comprises methylcellulose (Mongtomery at claim 13). Mongtomery recites wherein the temperature sensitive polymer comprises hydroxypropyl methylcellulose (Mongtomery at claim 14). Mongtomery recites wherein the temperature sensitive polymer comprises a poly(oxyethylene)-poly(oxypropylene) block copolymer (Mongtomery at claim 15). Montgomery teaches the use of suitable humectants includes but is not limited to glycerin, sorbitol, xylitol, mannitol, lactitol, maltitol, and other sugar alcohols, polyethylene glycol, propylene glycol, and other edible polyhydric alcohols and mixtures thereof (Mongtomery at [0051]). Mongtomery teaches the use of ammonium salts (Mongtomery at [0034]). Mongtomery teaches the use of acids (Mongtomery at [0055).
The teachings of Mongtomery differ from the instant claims insofar as they don’t teach a wider range of ammonium salts. The teachings of Takamori et al cure this deficit.
Takamori recites a radical generation catalyst and a radical generation source, the said radical generating catalyst contains the one or both of the substance which has at least one of an ammonium and its salt, and the substance which has at least one of a Lewis acid and a Bronsted acidity. The drug according to claim 1, wherein the ammonium is represented by the following chemical formula (XI).
In the chemical formula (XI),
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R 11 , R 21 , R 31 , and R 41 are each a hydrogen atom or an alkyl group, and may include an ether bond, a ketone (carbonyl group), an ester bond, an amide bond, or an aromatic ring. , R 11 , R 21 , R 31 , and R 41 may be the same or different, X − is an anion (Takamori at claims). Takamori recites wherein the ammonium represented by the chemical formula (XI) is an ammonium represented by the following chemical formula (XII).
In the chemical formula (XII),
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R 111 is an alkyl group having 5 to 40 carbon atoms, and may include an ether bond, a ketone (carbonyl group), an ester bond, an amide bond, or an aromatic ring, R 21 and X − are the same as those in the chemical formula (XI). (Takamori at claims). Takamori recites wherein the ammonium represented by the chemical formula (XII) is an ammonium represented by the following chemical formula (XIII).
In the chemical formula (XIII),
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R 111 and X − are the same as those in the chemical formula (XII) (Takamori at claims). Takamori recites ammonium represented by the chemical formula (XII) is benzethonium chloride, benzalkonium chloride, hexadecyltrimethylammonium chloride, tetramethylammonium chloride, ammonium chloride, tetrabutylammonium chloride, cetylpyridinium chloride, hexadecyltrimethylammonium bromide, Decalinium chloride, edrophonium, didecyldimethylammonium chloride, benzyltriethylammonium chloride, oxitropium, carbachol, glycopyrronium, safranine, sinapine, tetraethylammonium bromide, hexadecyltrimethylammonium bromide, squisametonium, sphingomyelin, denatonium, trigonelline , Neostigmine, paraquat, pyridostigmine, ferrodendrine, pralidoxime iodomethane , Betaine, betanin, bethanechol, betalains, lecithin, and at least is one third aspect agent selected from the group consisting of choline compounds (Takamori at claims). Takamori recites wherein the ammonium represented by the chemical formula (XII) is benzethonium chloride (Takamori at claims). Takamori recites wherein the radical generation source contains an oxo acid (Takamori at claims). Takamori recites the oxo acid is boric acid, carbonic acid, ortho carbonic acid, carboxylic acid, silicic acid, nitrous acid, nitric acid, phosphorous acid, phosphoric acid, arsenic, sulfurous acid, sulfuric acid, sulfonic acid, sulfinic acid, chromic acid, dichromic acid, peroxygen (Takamori at claims). Takamori recites which is at least one selected from the group consisting of manganic acid and halogenoxoacids (Takamori at claims). Takamori recites the halogen oxo acid is hypochlorous acid, chlorous acid, chloric acid, perchloric acid, hypobromous acid, bromous acid, bromic acid, perbrominated acid, hypoiodous acid, iodic acid, iodic acid (Takamori at claims). Takamori recites which is at least one selected from the group consisting of and periodic acid (Takamori at claims). Takamori recites the radical generating source includes at least one selected from the group consisting of a halogen ion, a hypohalite ion, a halite ion, a halogenate ion, and a perhalogenate ion (Takamori at claims). Takamori recites wherein the oxo acid is a halogen oxo acid or a salt thereof (Takamori at claims). Takamori recites wherein the halogen oxo acid is chlorine oxo acid (Takamori at claims). Takamori recites wherein the oxo acid contains chlorite ion (Takamori at claims). Takamori recites, the chemical medical agent as described in any one of Claim 1 to 13 containing at least one of water and an organic solvent (Takamori at claims). Takamori recites which is a bactericidal agent (Takamori at claims). Takamori teaches the composition is a oral care composition (Takamori at page 5).
The teaches of Takamori differ from instant claim 1 insofar as they do not specifically teach the use of a semi-solid. The teachings of Mongtomery cure this deficit.
It would have been prima facie obvious to have combined the ammonium salt of Tokamori with the ammonium salt of Mongtomery for the predictable result of an oral care composition with an ammonium salt. See MPEP 2144.06(I). See MPEP2144.07.
Regarding instant claim 1, Mongtomery recites a liquid oral therapeutic dental composition, that increases in viscosity upon contact with moisture following application to an oral cavity surface, comprising: a moisture responsive gel carrier comprising a moisture sensitive polymer complex and a water-soluble salt; and a therapeutic agent dispersed in the responsive gel carrier (Mongtomery at claim 1). Mongtomery recites wherein the therapeutic agent is selected from the group consisting of antimicrobial agents, tooth whiteners, anti-inflammatory agents, tooth desensitizers, anticaries agents, tartar control agents, tooth and gum surface protectants, tooth stain prevention agents and agents effective against dental plaque, halitosis, gingivitis, periodontal disease, oral ulcers and other diseases, afflictions or symptoms of the oral cavity (Mongtomery at claim 4). Montgomery teaches the use of ammonium salts (Montgomery at [0034]). Montgomery teaches the use of 2.5% of a (29% solution) of ammonium solution in Examples which would be approximately 0.7525%. Montgomery further teaches that carboxypolymethylene/PVP complexes achieve unexpectedly low viscosities in the presence of a water-soluble salts, including but not limited to alkali metal salts such as sodium and potassium salt and/or ammonium salt. It would have been prima facie obvious to one of ordinadry skill in the art to have optimized the amount of ammonium salt in the composition of Montgomery to control the viscosity of the composition. See MPEP 2144.05(II). Montgomery teaches the use of acids (Montgomery at [0055). Montgomery teaches the use of suitable humectants includes but is not limited to glycerin, sorbitol, zylitol, mannitol, lactitol, maltitol, and other sugar alcohols, polyethylene glycol, propylene glycol, and other edible polyhydric alcohols and mixtures thereof (Mongtomery at [0051]). Takamori teaches wherein the ammonium is represented by the following chemical formula (XI).
In the chemical formula (XI),
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R 11 , R 21 , R 31 , and R 41 are each a hydrogen atom or an alkyl group, and may include an ether bond, a ketone (carbonyl group), an ester bond, an amide bond, or an aromatic ring. , R 11 , R 21 , R 31 , and R 41 may be the same or different, X − is an anion (Takamori at claims). Takamori further recites wherein the ammonium represented by the chemical formula (XI) is an ammonium represented by the following chemical formula (XII).
In the chemical formula (XII), R 111 is an alkyl group having 5 to 40 carbon atoms, and may include an ether bond, a ketone (carbonyl group), an ester bond, an amide bond, or an aromatic ring, R 21 and X − are the same as those in the chemical formula (XI). (Takamori at claims).
Regarding instant claim 9, Takamori recites the halogen oxo acid is hypochlorous acid, chlorous acid, chloric acid, perchloric acid, hypobromous acid, bromous acid, bromic acid, perbrominated acid, hypoiodous acid, iodic acid, iodic acid (Takamori at claims).
Regarding instant claim 11, Takamori teaches the use of phosphocholine which is a phospholipid (Takamoria at page 3).
Regarding instant claim 13 and 15, Takamori teaches wherein the ammonium is represented by the following chemical formula (XI).
In the chemical formula (XI),
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R 11 , R 21 , R 31 , and R 41 are each a hydrogen atom or an alkyl group, and may include an ether bond, a ketone (carbonyl group), an ester bond, an amide bond, or an aromatic ring. , R 11 , R 21 , R 31 , and R 41 may be the same or different, X − is an anion (Takamori at claims). Takamori further recites wherein the ammonium represented by the chemical formula (XI) is an ammonium represented by the following chemical formula (XII).
In the chemical formula (XII), R 111 is an alkyl group having 5 to 40 carbon atoms, and may include an ether bond, a ketone (carbonyl group), an ester bond, an amide bond, or an aromatic ring, R 21 and X − are the same as those in the chemical formula (XI). (Takamori at claims).
Regarding instant claim 14, Mongtomery recites wherein the water soluble salt is selected from the group consisting of sodium saccharin, sodium chloride, potassium chloride, and ammonium chloride (Mongtomery at claim 12).
Regarding instant claim 16, Takamori teaches that the Lewis acidity of the radical generating catalyst contained in the agent of the present invention (hereinafter sometimes referred to as “radical generating catalyst of the present invention”) is, for example, 0.4 eV or more(Takamori at [1 .Drug]).
Regarding instant claim 17-25, Mongtomery recites a liquid oral therapeutic dental composition, that increases in viscosity upon contact with moisture following application to an oral cavity surface, comprising: a moisture responsive gel carrier comprising a moisture sensitive polymer complex and a water-soluble salt; and a therapeutic agent dispersed in the responsive gel carrier (Mongtomery at claim 1). Mongtomery recites wherein the therapeutic agent is selected from the group consisting of antimicrobial agents, tooth whiteners, anti-inflammatory agents, tooth desensitizers, anticaries agents, tartar control agents, tooth and gum surface protectants, tooth stain prevention agents and agents effective against dental plaque, halitosis, gingivitis, periodontal disease, oral ulcers and other diseases, afflictions or symptoms of the oral cavity (Mongtomery at claim 4).
Response to Arguments
Applicant's arguments filed 05/04/2026 have been fully considered but they are not persuasive.
Applicant argues the amended claims recite that the oral deposits are softened by the oral care composition and therefore the obviousness rejection should be withdrawn.
The Examiner does not agree. See the 112d rejection and claim interpretation above. The oral care composition is a composition comprising components. The intended use of the composition is an action the composition is intended to preform that does not provide a structural difference to the composition to the best of the Examiner’s understanding and is therefore not further limiting to the claim. As such, the Applicant’s arguments are not persuasive and the obviousness rejection is maintained.
Applicant argues that Montgomery teaches a liquid product that would not remain on the applied surface and therefore the obviousness rejection should be withdrawn.
The Examiner does not agree. Mongtomery recites a liquid oral therapeutic dental composition, that increases in viscosity upon contact with moisture following application to an oral cavity surface, comprising: a moisture responsive gel carrier comprising a moisture sensitive polymer complex and a water-soluble salt; and a therapeutic agent dispersed in the responsive gel carrier (Mongtomery at claim 1). The purpose of Mongtomery is that the viscosity changes, that it may be applied as a liquid that turns into a gel that stays on the oral cavity thereby eliminating the need for a dental tray or delivery device. “The present invention relates to a novel therapeutic dental gel composition having responsive gelling properties, such that when placed in the oral cavity, the composition increases in viscosity and the therapeutic agent contained therein retains activity at the site of application for longer periods of time than prior art compositions and methods of applying them.” (Mongtomery at [0011]). As such, the Applicant’s arguments are not persuasive and the obviousness rejection is maintained.
Applicant argues that Takamori is silent to viscosity and therefore the obviousness rejection should be withdrawn.
The Examiner does not agree. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As such, the Applicant’s arguments are not persuasive and the obviousness rejection is maintained.
Applicant argues that there would be no reason to combine Mongtomery and Takamori therefore the obviousness rejection should be withdrawn.
The Examiner does not agree. Mongtomery recites a liquid oral therapeutic dental composition, that increases in viscosity upon contact with moisture following application to an oral cavity surface, comprising: a moisture responsive gel carrier comprising a moisture sensitive polymer complex and a water-soluble salt; and a therapeutic agent dispersed in the responsive gel carrier (Mongtomery at claim 1). Mongtomery teaches the use of ammonium salts as a water-soluble salt to provide the viscosity change (Mongtomery at [0034]). Mongtomery further teaches the use of therapeutic agents or oral care agents (Mongtomery at [0043]). Mongtomery teaches the use of acids (Mongtomery at [0055).Takamori teaches that the composition can be an oral care agent (Takamori at page 5). It would have been prima facie obvious to have combined the ammonium salt of Tokamori with the ammonium salt of Mongtomery for the predictable result of an oral care composition with an ammonium salt. See MPEP 2144.06(I). See MPEP2144.07. As such, the Applicant’s arguments are not persuasive and the obviousness rejection is maintained.
Conclusion
No claims are presently allowable.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA MICHELLE PETRITSCH whose telephone number is (571)272-6812. The examiner can normally be reached M-F 08:30-17:00 EST ALT Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup, can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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