DETAILED ACTION
Applicants' arguments, filed 07/06/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 is a CIP of 17/105,748 filed on 11/27/2020, which claims domestic priority to PRO 62/943,556 filed on 12/04/2019.
Claim Interpretation
With regards to the term petrolatum, the instant specification recites at [0016] “Preferred examples include petrolatum, a mineral oil (Vaseline oil), which may be any petroleum based product”. Searches also indicate that mineral oil is a synonym for Petrolatum 36%, Paraffinum Liquidum, Heavy Liquid Petrolatum, Liquid Petrolatum, Paraffin- Liquid, Petrolatum- Liquid and vaseline. See Pubchem search entry for mineral oil filed 09/09/2025. Applicant has made clear in the remarks filed 11/10/2025 that they consider petrolatum and mineral oil as district compounds wherein mineral oil is a liquid and petrolatum is a semi-solid gel. As such, the term petrolatum will be interpreted as a semi-solid gel.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4, 6-7, 15, 19, and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The amendment to claim 4 recites “A canine antimicrobial dental gel consisting of:” it is presently unclear that the Applicant has possession of a dental gel with just the listed ingredients in the totality of the listed range and no further thickeners or viscosity modifiers that the original claims comprising would allow to be included. It is presently unclear that a gel would be formed when 75% of the composition is corn syrup. The instant specification recites “Suitable humectants include, but are not limited to glycthen, lactic acid, polyols, propylene glycol, corn syrup, high fructose corn syrup (HFCS), including Cornsweet 55 and Cornsweet 42, and sorbitol. The preferred form of humectant is a combination of non-crystallizing liquid sorbitol (70 wt. % sorbitol in water) and glycerine. The preferred dental gel has about 34 to 75 wt. % humectant. The more preferred preferred dental gel has from about 14 wt. % to about 55 wt. % sorbitol and from about 20 wt. % to about 25 wt. % glycerin. In a preferred embodiment, the dental gel has a ratio of sorbitol to glycerin of about 1:2 to 2:1.”. This does not lend to enablement of a gel with just the listed components as the amount of high fructose corn syrup or corn syrup is not detailed further than a general listing in the humectant section. It is unclear how one of ordinary skill in the art would make a gel using just the listed components in the listed ranges. Further, all the examples of the specification detail a combination of sorbitol and glycerin. As such there is not sufficient support for the enablement or creation of a dental gel with just the listed ingredients in the totality of the listed ranges in the specification or the amended claims. As such claim 4 is rejected. The claims 6-7, 15, 19, and 22 depend from claim 4 and are therefore also rejected.
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 4, 6-7, 15, 19, and 22 are rejected above for enablement, the obviousness rejections provided for these claims below provide the Examiner’s examination of the original enabled open language of the claim “comprising” for the purpose of compact prosecution and to provide the closest possible prior art to the Applicant while the enablement rejection is resolved. The closest prior art may change as the enablement rejection is resolved.
A) Claims 1-4, 6-7, 14-15, 18-19 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Nordgren et al. (US Patent Application Publication 20160347829A1).
Nordgren teaches an oral health composition for humans and non-humans (Nordgren at abstract). Nordgren teaches that the composition can be used on canines (Nordgren at [0161]), and further teaches that composition is tested on beagles, a specific breed of dog (Nordgren at Examples). Nordgren teaches the use of lipids specifically PEG 3350 (Dow Chemical) and PEG 4000, corn oil, mineral oil, hydrogenated vegetable oils (STEROTEX or LUBRITAB), peanut oil and/or castor oil, in a range from 1% to 20% (Nordgren at [0120]). Nordgren teaches the use of lecithin, phospholipid surfactant, in a range of 0.25% to 25% (Nordgren at [0282-0284]). Nordgren teaches the use of sorbitol in a range of 1% to 50% (Nordgren at [0104-0105]) and glycerin in a range of 1% to 25% (Nordgren at [0112-0114]). Nordgren teaches the use of chlorhexidine digluconate, (Nordgren at [0050]) and further teaches the use of chlorhexidine in a range of 0.01% to 5% (Nordgren at [0121]). Nordgren does not require breath freshening agents nor does it require a surfactant with a HLB of 2.8 consisting of propylene glycol monoglyceride and propylene glycerol diglyceride. Nordgren teaches the use of sodium carbonate in a range of 0.1% to 5% (Nordgren at [0123]). Nordgren teaches the use of sodium bicarbonate (Nordgren at [0089]). Nordgren teaches the use of flavors like beef, cheese, and bacon in a range from 5% to 40% (Nordgren at [0124-0129]). Nordgren teaches the use of corn syrup in a range of about 1% to about 30% (Nordgren at [0111]). Nordgren teaches that the composition may be a gel, toothpaste or dentifrice (Nordgren at [0052]) and further teaches the use of an applicator (Nordgren at [0234, subset 35]).
Nordgren differs from the instant claims in this rejection insofar as it does not teach the combination of the instantly recited components with sufficient specificity for anticipation. Nordgren teaches the components of the instant recited composition and uses each component of their established function in the art but does not explicitly combine the components together into a single embodiment or a preferred composition. However, given the disclosure of each component individually, it would have been prima facie obvious to a person having ordinary skill in the art at a time prior to the filing of the present patent application and following the teachings of Nordgren to have selected and combined known components for their established functions with predictable results. MPEP §2143 and §2144.06(I).
Regarding instant claim 1, Nordgren teaches an oral health composition for humans and non-humans (Nordgren at abstract). Nordgren teaches that the composition can be used on canines (Nordgren at [0161]), and further teaches that composition is tested on beagles, a specific breed of dog (Nordgren at Examples). Nordgren teaches the use of lipids specifically PEG 3350 (Dow Chemical) and PEG 4000, corn oil, mineral oil, hydrogenated vegetable oils (STEROTEX or LUBRITAB), peanut oil and/or castor oil, in a range from 1% to 20% (Nordgren at [0120]), which overlaps the instantly claimed range of about 4% to 33%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Nordgren teaches the use of lecithin, phospholipid surfactant, in a range of 0.25 to 25% (Nordgren at [0282-0284]), which overlaps the instantly claimed range of about 8% to 29%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Nordgren teaches the use of corn syrup in a range of about 1% to about 30% (Nordgren at [0111]), which approaches the instantly claimed range of about 34% to 75% of humectant. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP§2144.05(I). It would be prima facie obvious to have optimized the amount of corn syrup in the composition to get the preferred texture and sweetness of the gel. See MPEP 2144.05(II). Nordgren teaches the use of chlorhexidine digluconate, (Nordgren at [0050]) and further teaches the use of chlorhexidine in a range of 0.01% to 5% (Nordgren at [0121]), which overlaps the instantly claimed range of about 0.01% to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Nordgren does not require breath freshening agents nor does it require a surfactant with a HLB of 2.8 consisting of propylene glycol monoglyceride and propylene glycerol diglyceride.
Regarding instant claim 2, Nordgren teaches the use of sodium carbonate in a range of 0.1% to 5% (Nordgren at [0123]), which overlaps the instantly claimed range of up to about up to 0.5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
Regarding instant claim 3, Nordgren teaches the use of flavors like beef, cheese, and bacon in a range from 5% to 40% (Nordgren at [0124-0129]), which overlaps the instantly claimed range of about 0.5% to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 4, Nordgren teaches an oral health composition for humans and non-humans (Nordgren at abstract). Nordgren teaches that the composition can be used on canines (Nordgren at [0161]), and further teaches that composition is tested on beagles, a specific breed of dog (Nordgren at Examples). Nordgren teaches the use of lipids specifically PEG 3350 (Dow Chemical) and PEG 4000, corn oil, mineral oil, hydrogenated vegetable oils (STEROTEX or LUBRITAB), peanut oil and/or castor oil, in a range from 1% to 5% (Nordgren at [0120]), which overlaps the instantly claimed range of about 4% to 5%. Nordgren teaches the use of lecithin, phospholipid surfactant, in a range of 0.25 to 25% (Nordgren at [0282-0284]), which overlaps the instantly claimed range of about 8% to 12%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Nordgren teaches the use of corn syrup in a range of about 1% to about 30% (Nordgren at [0111]), which approaches the instantly claimed range of about 34% to 75% of humectant. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP§2144.05(I). It would be prima facie obvious to have optimized the amount of corn syrup in the composition to get the preferred texture and sweetness of the gel. See MPEP 2144.05(II). Nordgren teaches the use of chlorhexidine digluconate, (Nordgren at [0050]) and further teaches the use of chlorhexidine in a range of 0.01% to 5% (Nordgren at [0121]), which overlaps the instantly claimed range of about 0.01% to 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Nordgren teaches the use of sodium carbonate in a range of 0.1% to 5% (Nordgren at [0123]), which overlaps the instantly claimed range of about 0% to 0.5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Nordgren teaches the use of flavors like beef, cheese, and bacon in a range from 5% to 40% (Nordgren at [0124-0129]), which overlaps the instantly claimed range of about 0.5% to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Nordgren does not require breath freshening agents nor does it require a surfactant with a HLB of 2.8 consisting of propylene glycol monoglyceride and propylene glycerol diglyceride.
Regarding instant claim 6, Nordgren teaches the use of chlorhexidine digluconate, (Nordgren at [0050]).
Regarding instant claim 7, Nordgren teaches the use of sodium carbonate (Nordgren at [0123]).
Regarding instant claim 14, Nordgren teaches the use of sorbitol from 1% to 50% (Nordgren at [0104-0105]) and glycerin in a range of 1% to 25% (Nordgren at [0112-0114]). Sorbitol and glycerin in these ranges would overlap with the instantly claimed ratio range of about 1:2 to 2:1. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 15, Nordgren teaches the use of sorbitol from 1% to 50% (Nordgren at [0104-0105]) and glycerin in a ratio range of 1% to 25% (Nordgren at [0112-0114]). Sorbitol and glycerin in these ranges would overlap with the instantly claimed ratio range of about 1:2 to 2:1. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 18, Nordgren teaches the use of lipids specifically PEG 3350 (Dow Chemical) and PEG 4000, corn oil, mineral oil, hydrogenated vegetable oils (STEROTEX or LUBRITAB), peanut oil and/or castor oil, in a range from 1% to 5% (Nordgren at [0120]). Nordgren does not require mineral oil.
Regarding instant claim 19, Nordgren teaches the use of lipids specifically PEG 3350 (Dow Chemical) and PEG 4000, corn oil, mineral oil, hydrogenated vegetable oils (STEROTEX or LUBRITAB), peanut oil and/or castor oil, in a range from 1% to 5% (Nordgren at [0120]). Nordgren does not require mineral oil.
Regarding instant claim 21, Nordgren does not require breath freshening agents.
Regarding instant claim 22, Nordgren does not require breath freshening agents.
B) Claims 8-12,16, 20, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Nordgren et al. (US Patent Application Publication 20160347829A1) as applied to claims 1-4, 6-7, 14-15, 18-19 and 21-22 above, and further in view of Zelgis (US Patent Application Publication 20060264497A1).
Nordgren teaches an oral health composition for humans and non-humans (Nordgren at abstract). Nordgren teaches that the composition can be used on canines (Nordgren at [0161]), and further teaches that composition is tested on beagles, a specific breed of dog (Nordgren at Examples). Nordgren teaches the use of lipids specifically mineral oil, aka petrolatum, in a range from 1% to 20% (Nordgren at [0120]). Nordgren teaches the use of lecithin, phospholipid surfactant, in a range of 0.25% to 25% (Nordgren at [0282-0284]). Nordgren teaches the use of sorbitol in a range of 1% to 50% (Nordgren at [0104-0105]) and glycerin in a range of 1% to 25% (Nordgren at [0112-0114]). Nordgren teaches the use of chlorhexidine digluconate, (Nordgren at [0050]) and further teaches the use of chlorhexidine in a range of 0.01% to 5% (Nordgren at [0121]). Nordgren does not require breath freshening agents nor does it require a surfactant with a HLB of 2.8 consisting of propylene glycol monoglyceride and propylene glycerol diglyceride. Nordgren teaches the use of sodium carbonate in a range of 0.1% to 5% (Nordgren at [0123]). Nordgren teaches the use of sodium bicarbonate (Nordgren at [0089]). Nordgren teaches the use of flavors like beef, cheese, and bacon in a range from 5% to 40% (Nordgren at [0124-0129]). Nordgren teaches the use of corn syrup in a range of about 1% to about 30% (Nordgren at [0111]). Nordgren teaches that the composition may be a gel, toothpaste or dentifrice (Nordgren at [0052]) and further teaches the use of an applicator (Nordgren at [0234, subset 35]).
Nordgren differs from the instant claims in this rejection insofar as it does not teach the use of petrolatum the semi-solid gel. The teachings of Zelgis cure this deficit.
Zelgis teaches that compositions are used to prevent and reverse oral mucosal disorders and bone loss (osteopenia and osteoporosis) associated with aging and chronic inflammation. Oral mucosal disorders include periodontitis, gingivitis and related oral mucosal inflammation. Formulations of the compositions of the invention include capsules, tablets, toothpastes, oral gels, mouthwashes, mouth rinses, lozenges, chewing gum, dental floss, and dental topical formulations, and fortified foods (Zelgis at abstract). Zelgis teaches that the subject is a mammal like a dog or cat or mouse (Zelgis at [0105]). Zelgis teaches that suitable viscosity modifiers can be added to the compositions of the present invention. These viscosity modifiers include, polybutene, mineral oil, oregano modified clays, petrolatum, silicas, and mixtures thereof. In one embodiment the viscosity modifier is silica. Where incorporated, the viscosity modifier is present in the polybutene component of the present invention at a level of from about 0.001% to about 30% (Zelgis at [0199]). Zelgis teaches that surfactants can be present in amount of about 0.5 to about 15 weight percent, more typically about 0.5 to about 10 weight percent (Zelgis at [0184]). Zelgis teaches that suitable humectants include sorbitol, glycerol, propylene glycol, 1,3-butylene glycol, polyethylene glycol, xylitol, maltitol, lactitol, or the like. The humectant can also be used as the bulk carrier in many instances, in which case it can be present in an amount of about 5 to about 90 weight percent (Zelgis at [0188]). Zelgis teaches the use of corn syrup and high fructose corn syrup (Zelgis at [0234]). Zelgis teaches the use of chlorhexidine digluconate (Zelgis at [0180]). Zelgis teaches the use of glycerin used in a range of 0.3% to about 30% (Zelgis at [0187]). Zelgis teaches that flavoring agents can be present, either individually or collectively, in an amount of about 0.1 to about 10 weight percent (Zelgis at [0190]).
Zelgis differs from the instant claims in this rejection insofar as it does not teach the use of lecithin or buffers. The teachings of Nordgren cure this deficit.
It would have been prima facie obvious to have combined petrolatum with the lipids of Nordgren for a predictable result of a gel with lipids. It would be prima facie obvious to one of ordinary skill in the art to have combined the mineral oil and petrolatum of Zelgis with the mineral oil of Nordgren to produce a composition with the appropriate viscosity texture and mouthfeel of a dental gel. See MPEP 2144.06(II). One would have a reasonable expectation of success because both Zelgis and Nordgren teach dental gels for dogs that contain humectants, surfactants, sorbitol, glycerol, glycerin, corn syrup, high fructose corn syrup and chlorhexidine digluconate. One would have been motivated to have added the petrolatum lipid of Zelgis to the composition of Nordgren for the benefit of viscosity modification as taught by Zelgis. See MPEP 2144(II).
Regarding instant claim 1, Nordgren teaches an oral health composition for humans and non-humans (Nordgren at abstract). Nordgren teaches that the composition can be used on canines (Nordgren at [0161]), and further teaches that composition is tested on beagles, a specific breed of dog (Nordgren at Examples). Nordgren teaches the use of lipids specifically PEG 3350 (Dow Chemical) and PEG 4000, corn oil, mineral oil, hydrogenated vegetable oils (STEROTEX or LUBRITAB), peanut oil and/or castor oil, in a range from 1% to 20% (Nordgren at [0120]), which overlaps the instantly claimed range of about 4% to 33%. Zelgis teaches the use of petrolatum in a range of about 0.001% to about 30% (Zekgus at [0199]), which overlaps the instantly claimed range of about 4% to 33%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Nordgren teaches the use of lecithin, phospholipid surfactant, in a range of 0.25 to 25% (Nordgren at [0282-0284]), which overlaps the instantly claimed range of about 8% to 29%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Nordgren teaches the use of corn syrup in a range of about 1% to about 30% (Nordgren at [0111]), which approaches the instantly claimed range of about 34% to 75% of humectant. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP§2144.05(I). It would be prima facie obvious to have optimized the amount of corn syrup in the composition to get the preferred texture and sweetness of the gel. See MPEP 2144.05(II). Nordgren teaches the use of chlorhexidine digluconate, (Nordgren at [0050]) and further teaches the use of chlorhexidine in a range of 0.01% to 5% (Nordgren at [0121]), which overlaps the instantly claimed range of about 0.01% to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Nordgren does not require breath freshening agents nor does it require a surfactant with a HLB of 2.8 consisting of propylene glycol monoglyceride and propylene glycerol diglyceride.
Regarding instant claim 2, Nordgren teaches the use of sodium carbonate in a range of 0.1% to 5% (Nordgren at [0123]), which overlaps the instantly claimed range of up to about up to 0.5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
Regarding instant claim 3, Nordgren teaches the use of flavors like beef, cheese, and bacon in a range from 5% to 40% (Nordgren at [0124-0129]), which overlaps the instantly claimed range of about 0.5% to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
Regarding instant claim 4, Nordgren teaches an oral health composition for humans and non-humans (Nordgren at abstract). Nordgren teaches that the composition can be used on canines (Nordgren at [0161]), and further teaches that composition is tested on beagles, a specific breed of dog (Nordgren at Examples). Nordgren teaches the use of lipids specifically PEG 3350 (Dow Chemical) and PEG 4000, corn oil, mineral oil, hydrogenated vegetable oils (STEROTEX or LUBRITAB), peanut oil and/or castor oil, in a range from 1% to 5% (Nordgren at [0120]), which overlaps the instantly claimed range of about 4% to 5%. Zelgis teaches the use of petrolatum in a range of about 0.001% to about 30% (Zekgus at [0199]), which overlaps the instantly claimed range of about 4% to 5%. Nordgren teaches the use of lecithin, phospholipid surfactant, in a range of 0.25 to 25% (Nordgren at [0282-0284]), which overlaps the instantly claimed range of about 8% to 12%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Nordgren teaches the use of corn syrup in a range of about 1% to about 30% (Nordgren at [0111]), which approaches the instantly claimed range of about 34% to 75% of humectant. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP§2144.05(I). It would be prima facie obvious to have optimized the amount of corn syrup in the composition to get the preferred texture and sweetness of the gel. See MPEP 2144.05(II). Nordgren teaches the use of chlorhexidine digluconate, (Nordgren at [0050]) and further teaches the use of chlorhexidine in a range of 0.01% to 5% (Nordgren at [0121]), which overlaps the instantly claimed range of about 0.01% to 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Nordgren teaches the use of sodium carbonate in a range of 0.1% to 5% (Nordgren at [0123]), which overlaps the instantly claimed range of about 0% to 0.5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Nordgren teaches the use of flavors like beef, cheese, and bacon in a range from 5% to 40% (Nordgren at [0124-0129]), which overlaps the instantly claimed range of about 0.5% to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Nordgren does not require breath freshening agents nor does it require a surfactant with a HLB of 2.8 consisting of propylene glycol monoglyceride and propylene glycerol diglyceride.
Regarding instant claim 6, Nordgren teaches the use of chlorhexidine digluconate, (Nordgren at [0050]).
Regarding instant claim 7, Nordgren teaches the use of sodium carbonate (Nordgren at [0123]).
Regarding instant claim 8, Nordgren teaches an oral health composition for humans and non-humans (Nordgren at abstract). Nordgren teaches that the composition can be used on canines (Nordgren at [0161]), and further teaches that composition is tested on beagles, a specific breed of dog (Nordgren at Examples). Nordgren teaches the use of lipids specifically PEG 3350 (Dow Chemical) and PEG 4000, corn oil, mineral oil, hydrogenated vegetable oils (STEROTEX or LUBRITAB), peanut oil and/or castor oil, in a range from 1% to 20% (Nordgren at [0120])Zelgis teaches the use of petrolatum in a range of about 0.001% to about 30% (Zekgus at [0199]), which overlaps the instantly claimed range of about 4% to 33%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Nordgren teaches the use of lecithin, phospholipid surfactant, in a range of 0.25 to 25% (Nordgren at [0282-0284]), which overlaps the instantly claimed range of about 8% to 29%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Nordgren teaches the use of sorbitol from 1% to 50% (Nordgren at [0104-0105]) and glycerin in a range of 1% to 25% (Nordgren at [0112-0114]), which overlaps about 14% to 55% of sorbitol and about 20% to 25% of glycerin. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Nordgren teaches the use of chlorhexidine digluconate, (Nordgren at [0050]) and further teaches the use of chlorhexidine in a range of 0.01% to 5% (Nordgren at [0121]), which overlaps the instantly claimed range of about 0.01% to 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). Nordgren teaches the use of sodium bicarbonate (Nordgren at [0089]) which is not required by the instant claim as it can be used in an amount of 0 wt%. Nordgren teaches the use of sodium carbonate in a range of 0.1% to 5% (Nordgren at [0123]), which overlaps the instantly claimed range of up to about up to 0.5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Nordgren teaches the use of flavors like beef, cheese, and bacon in a range from 5% to 40% (Nordgren at [0124-0129]), which overlaps the instantly claimed range of about 0.5% to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Nordgren does not require breath freshening agents nor does it require a surfactant with a HLB of 2.8 consisting of propylene glycol monoglyceride and propylene glycerol diglyceride.
Regarding instant claim 9, Nordgren teaches that the composition can be a gel that is applied to the canine tooth/teeth (Nordgen at claim 12). Nordgen further teaches an applicator (Nordgen at [0234]).
Regarding instant claim 10, Nordgren teaches the use of lecithin, phospholipid surfactant, in a range of 0.25 to 25% (Nordgren at [0282-0284]) which overlaps the instantly claimed range of about 8% to 12%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 11, Nordgren teaches the use of lipids specifically PEG 3350 (Dow Chemical) and PEG 4000, corn oil, mineral oil, hydrogenated vegetable oils (STEROTEX or LUBRITAB), peanut oil and/or castor oil, in a range from 1% to 20% (Nordgren at [0120]). Zelgis teaches the use of petrolatum in a range of about 0.001% to about 30% (Zekgus at [0199]), which overlaps the instantly claimed range of about 4% to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 12, Nordgren teaches the use of sorbitol from 1% to 50% (Nordgren at [0104-0105]), which overlaps with the instantly claimed range of about 45% to 55%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 14, Nordgren teaches the use of sorbitol from 1% to 50% (Nordgren at [0104-0105]) and glycerin in a range of 1% to 25% (Nordgren at [0112-0114]). Sorbitol and glycerin in these ranges would overlap with the instantly claimed ratio range of about 1:2 to 2:1. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 15, Nordgren teaches the use of sorbitol from 1% to 50% (Nordgren at [0104-0105]) and glycerin in a ratio range of 1% to 25% (Nordgren at [0112-0114]). Sorbitol and glycerin in these ranges would overlap with the instantly claimed ratio range of about 1:2 to 2:1. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 16, Nordgren teaches the use of sorbitol from 1% to 50% (Nordgren at [0104-0105]) and glycerin in a range of 1% to 25% (Nordgren at [0112-0114]). Sorbitol and glycerin in these ranges would fall within the instantly claimed ratio range of about 1:2 to 2:1. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 18, Nordgren teaches the use of lipids specifically PEG 3350 (Dow Chemical) and PEG 4000, corn oil, mineral oil, hydrogenated vegetable oils (STEROTEX or LUBRITAB), peanut oil and/or castor oil, in a range from 1% to 5% (Nordgren at [0120]). Nordgren does not require mineral oil.
Regarding instant claim 19, Nordgren teaches the use of lipids specifically PEG 3350 (Dow Chemical) and PEG 4000, corn oil, mineral oil, hydrogenated vegetable oils (STEROTEX or LUBRITAB), peanut oil and/or castor oil, in a range from 1% to 5% (Nordgren at [0120]). Nordgren does not require mineral oil.
Regarding instant claim 20, Nordgren does not require mineral oil nor does Zelgis require mineral oil.
Regarding instant claim 21, Nordgren does not require breath freshening agents.
Regarding instant claim 22, Nordgren does not require breath freshening agents.
Regarding instant claim 23, Nordgren does not require breath freshening agents nor does Zelgis require breath freshening agents.
C) Claims 9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Nordgren et al. (US Patent Application Publication 20160347829A1) and Zelgis (US Patent Application Publication 20060264497A1) as applied to claims 1-4, 6-7, 8-12, 14-16, and 18-23 above, and further in view of Yuhas et al (US Patent Application Publication 20070177929 A1).
The teachings of Nordgren and Zelgis are discussed above. Nordgren teaches that the composition can be a gel that is applied to the canine tooth/teeth (Nordgren at claim 12). Nordgen further teaches an applicator (Nordgren at [0234]). Nordgren teaches that the composition may be a gel, toothpaste or dentifrice (Nordgen at [0052]) and further teaches the use of an applicator (Nordgren at [0220]).
The teachings of Nordgren and Zelgis differ from instant claim 9 insofar as the components of the applicator are not described. The teachings of Yuhas cure this deficit.
Yuhas teaches an applicator for gel with multiple openings in the top and a tightening mechanism on the bottom. Yuhas contains a seal over the top openings to prevent leaking. The top of Yuhas applicator is smooth and curved as detailed in the figure below;
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(Yuhas at Figure 4). Notice in the diagram the incremental grip that increases the amount dispensed as it is rotated.
The teaching of Yuhas differs from the instant claim 1 insofar as it does not specifically teach the use of dental gel. The teachings of Nordgren and Zelgis cure this deficit.
One would be motivated to use the applicator of Yuhas for the dispersal of gels because of the top seal which prevents gel from leaking out. It would have been obvious to one of ordinary skill in the art have use the gel applicator of Yuhas for the gel taught in Nordgren for the benefit of a leak proof applicator as described in Yuhas. See MPEP 2144(II). It would be prima facie obvious for one of ordinadry skill in the art to have used the gel applicator of Yuhas to deliver the gel of Nordgren for the benefit of having a leak proof seal over the top opening. See MPEP 2143(I)(F) and MPEP 2143(I)(C).
Response to Arguments
Applicant's arguments filed 11/10/2025 have been fully considered but they are not persuasive.
Applicant argues that the prior art does not teach corn syrup for the same purpose or in a large enough amount therefore the obviousness rejection should be withdrawn.
The Examiner does not agree. Nordgren teaches the use of corn syrup in a range of about 1% to about 30% (Nordgren at [0111]), which approaches the instantly claimed range of about 34% to 75% of humectant. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP§2144.05(I). It would be prima facie obvious to have optimized the amount of corn syrup in the composition to get the preferred texture and sweetness of the gel. See MPEP 2144.05(II). The term “about” with regards to about 30% and about 34% could certainly be considered overlapping and definitely would be considered approaching, about is generally considered in plain language to be 5% to 10%. The term “about” being 10% would provide a range of 27-33% for the upper limit of the prior art and a range of 30.6% to 38.4% for the lower limit of the instant application which would be considered overlapping. The term “about” being 5% would provide a range of 28.5-31.5% for the upper limit of the prior art and a range of 32.3% to 35.7% for the lower limit of the instant application which would be considered approaching. The term “about” has not to the best of the Examiner’s understanding been defined in the instant claims or specification. Consistent with the well-established axiom in patent law that a patentee or applicant is free to be his or her own lexicographer, a patentee or applicant may use terms in a manner contrary to or inconsistent with one or more of their ordinary meanings if the written description clearly redefines the terms. See, e.g., Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). See MPEP 2173.05(a). The Examiner would like to note that the Examples of the instant specification do not use any corn syrup. As such, the Applicant’s argument is not persuasive, and the obviousness rejection is maintained.
Applicant argues that the Examiner used impermissible hindsight to combine the components of Nordgren and therefore the obviousness rejection should be withdrawn.
The Examiner does not agree. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). With regards to there being no reason to combine the components of Nordgren into a composition, Nordgren teaches the components in finite lists to be used together in a composition for dogs. (E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. See MPEP 2143(I)(E). The oral care components are taught to be used together to make a oral care composition therefore it would be obvious to have combined the taught oral care components for dogs for the same intended purpose in the art to be combined to form an oral care composition for dogs that provides the same intended purpose of oral care for dogs. As such, the Applicant’s argument is not persuasive, and the obviousness rejection is maintained.
Applicant argues that Zelgis does not teach petrolatum as the principle component at the claimed amount, teaching petrolatum as one of several viscosity modifiers including mineral oil, and has a preferred viscosity modifier of silica. Therefore, the obviousness rejection should be withdrawn.
The Examiner does not agree. Nordgren teaches the use of lipids specifically PEG 3350 (Dow Chemical) and PEG 4000, corn oil, mineral oil, hydrogenated vegetable oils (STEROTEX or LUBRITAB), peanut oil and/or castor oil, in a range from 1% to 20% (Nordgren at [0120]).Zelgis teaches the use of petrolatum in a range of about 0.001% to about 30% (Zelgis at [0199]), which overlaps the instantly claimed range of about 4% to 33%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I). One would have a reasonable expectation of success because Zelgis and Nordgren teach the use of lipids including mineral oil in similar ranges, it would be obvious to have combined the additional lipid, petrolatum, of Zelgis to the lipids of Nordgren for a canine gel containing lipids. See MPEP 2144.06(I). Zelgis provides a finite list which has components that overlap with Nordgren for lipids used in a canine gel. Selecting a lipid from a finite list would be obvious. See MPEP 2143(I)(E). "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). See MPEP2123(I). The prior art is good for all it contains that includes non-preferred embodiments and alternatives and general teachings like the use of petrolatum as a lipid. The teaching of preferred embodiments and examples do not teach away from the general teachings and non-preferred embodiments so even though Zelgis prefers silica it still teaches the use of petrolatum. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).See MPEP 2123(II). Furthermore, Nordgren and Zelgis do not need to teach the use of the lipids for the same reason as the instant application. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). See MPEP 2144(IV). As such, the Applicant’s argument is not persuasive, and the obviousness rejection is maintained.
Applicant argues that there would be no reason or motivation for Nordgren to use the petrolatum of Zelgis rather than the preferred silica as a viscosity modifier or to use a viscosity modifier at all rather than the mineral oil taught by Nordgren. Therefore, the obviousness rejection should be withdrawn
The Examiner does not agree. Zelgis teaches suitable viscosity modifiers can be added to the compositions of the present invention. These viscosity modifiers include, polybutene, mineral oil, oregano modified clays, petrolatum, silicas, and mixtures thereof. In one embodiment the viscosity modifier is silica (Zelgis at [0199]). Nordgren teaches may also include one or more lubricants/processing aids. In some cases, the lubricant/processing aid may also behave as a solvent, and accordingly, there some of the components of the inventive compositions may have dual functions. Lubricants/processing aids include, but are not limited to polyethylene glycols of various molecular weight ranges including PEG 3350 (Dow Chemical) and PEG 4000, corn oil, mineral oil, hydrogenated vegetable oils (STEROTEX or LUBRITAB), peanut oil and/or castor oil. In certain embodiments, the lubricant/processing aid is a neutral oil comprising a medium chain triglyceride or propylene glycol fatty acid esters including caprylic/capric triglycerides. Non-limiting examples of neutral oils are known by the trademark MIGLYOL® including MIGLYOL® 810, MIGLYOL® 812, MIGLYOL® 818, MIGLYOL® 829 and MIGLYOL® 840. If present, the lubricant/processing aid may be in the composition at a concentration of about 1% to about 20% (w/w) (Nordgren at [0120]). Lubricants and processing aids impact the viscosity, texture, and mouth feel of the composition. It would be prima facie obvious to have combined the mineral oil and petrolatum of Zelgis with the mineral oil of Nordgren to produce a composition with the appropriate viscosity texture and mouthfeel of a dental gel. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See MPEP 2144.06(I). The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). See MPEP2144.07. One would have been motivated to have used a viscosity modifier of Zelgis to optimize the viscosity and texture of the canine dental gel of Nordgren. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05(II). The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983).See MPEP 2144 (II). "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). See MPEP2123(I). The prior art is good for all it contains that includes non-preferred embodiments and alternatives and general teachings like the use of petrolatum as a lipid. The teaching of preferred embodiments and examples do not teach away from the general teachings and non-preferred embodiments so even though Zelgis prefers silica it still teaches the use of petrolatum. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).See MPEP 2123(II). Furthermore, Nordgren and Zelgis do not need to teach the use of the lipids for the same reason as the instant application. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). See MPEP 2144(IV). As such, the Applicant’s argument is not persuasive, and the obviousness rejection is maintained.
Applicant argues that Yuhas dispenses a continuous amount of product without clicking therefore the obviousness rejection should be withdrawn.
The Examiner does not agree. The applicator of Yuhas is substantially structurally identical to the described applicator of the instant application. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01. A threaded screw thread elevator would dispense product in a steady amount as the wheel is turned. Therefore, directions on how much to turn the wheel to dispense product would still work for the apparatus of Yuhas. Furthermore, the manner of operating the device does not differentiate the claim from the prior art. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). See MPEP 2114(II). The applicator of Yuhas adds more gel as the wheel is turned therefore it dispenses more as the wheel is turned. As such, the Applicant’s argument is not persuasive, and the obviousness rejection is maintained.
Applicator of Yuhas
Applicator of instant application
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Conclusion
No claims are presently allowable.
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 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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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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