DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of the method of Claims 1-18 and 20 in the reply filed on 3 June 2026 is acknowledged. The traversal is on the ground(s) that the Examiner has only offered a rationale, and not objective evidence, for concluding the inventions are independent and distinct. This is unpersuasive because the Examiner is not obligated to provide objective evidence when finding that two inventions are independent and distinct: all that is required is a concise statement of particular reasons the Examiner has for concluding inventions are independent and distinct. See MPEP § 808.01. Moreover, Applicants are reminded that the Examiner is under no obligation to document a specific example representing such a concise statement. See MPEP 808.06(h)(indicating the burden is on the examiner to provide an example, but the example need not be documented)(emphasis added). Applicants arguments concerning the undue search burden are likewise unpersuasive, as the Examiner has provided not one but two indicia establishing an undue search burden, as not only are the two inventions classified separately (See MPEP 808.02(A)), but also would require different search queries to address on one had the shampoo of Invention II, and the other the shampoo/diet combination required by Invention I. (See MPEP 808.02(C)).
The requirement is still deemed proper and is therefore made FINAL.
Status of the Claims
Claims 1-20 are pending.
Claim 19 is withdrawn from consideration as directed to a non-elected invention.
Claims 1-18 and 20 are presented for examination and rejected as set forth in greater detail below.
Priority
The instant application claims the benefit of provisional U.S. application 63/524,059 filed 29 June 2026.
Claim Interpretation
Applicants Claims 1 and 20 are directed to methods of treating pets by feeding them a diet combining multiple fatty acids, quercetin, and one or more vitamins and within a certain amount of time applying a composition comprising defined quantities of each of an amphoteric surfactant, a non-ionic surfactant, and a polyol. Dependent claim 2 requires the composition be removed after a defined period of time. Claims 2-5, 17, and 18 recite results the method of Claim 1 are to achieve, and which therefore fail to recite additional limitations the art to be relied on must address. A “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005) (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Claims 6 and 7 narrow the identity of the amphoteric surfactant to, among others, cocamidopropyl betaine. Claim 8 narrows the identity of the nonionic surfactant, with Claims 9 specifying that the weight ration of amphoteric to nonionic surfactant should fall within a defined range. Claim 10 narrows the identity of the polyol, and Claim 11 requires the addition of any of a Markush-type listing of alternative oils. Claim 12 indicates the composition applied is to be free, or substantially free, of anionic surfactants. Claim 13 indicates the food is to combine each of an omega-3, -6, and -9 fatty acid, with Claim 14 indicating that the fatty acids are to be present in the food in defined ratios. Claim 15 indicates that both vitamins C and E are present in the food composition. Claim 16 adds sodium gluconate to the shampoo composition.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 12 recites the broad recitation “substantially free…of an anionic surfactant,” and the claim also recites “or free, of an anionic surfactant,” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 1-15, 17, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gross (WO2017/057291) in view of Saridomichelakis (Manolis N. Saridomichelakis & Thierry Olivry, An Update on the Treatment of Canine Atopic Dermatitis, 207 Vet. J 29 (2016)), Jiang (CN110787091)(Machine translation provided; all references are to the machine translation), and Paye (Marc Paye, Chapter 43: Mechanism of Skin Irritation by Surfactants and Anti-Irritants for Surfactant-Based Products in Handbook of Cosmetic Science and Technology, 3d Ed. (Andre Barel, Marc Paye & Moward Maibach, eds.), (2009).
Gross describes methods of managing non-food allergies. (Abs.). Gross indicates that canine atopic dermatitis (AD), incorporating symptoms of erythema and alopecia, among others, may be treated by the methods described, with early intervention and continuing treatment recommended during the time prior to exposure to irritants to support skin repair and reduction of immune response. [22-26]. Treatment according to Gross involves the administration of a pet food composition combining omega-3, omega-6, and omega-9 fatty acids of the instant claims along with quercetin of the instant claims and each of vitamins C and E of Claims 1 and 20, preferably in a composition which provides the ratio of omega-3:omega-6:omega-9 fatty acids of about 0.5:2.0:2.0 recited by instant Claim 14. [4-6]. Gross indicates that nutritional management for AD can inhibit the inflammatory response, but additionally indicates that unhealthy skin, including in the ear canal, may further be addressed externally through, among others, gentle cleansing. [30]. Gross indicates that the food product may be prescribed by a veterinarian and the efficacy of such a regimen tracked as treatment progresses. [48]. Gross identified an exemplary trial whereby an exemplary embodiments of these foods were administered to dogs daily. [57]. This implies a 24 hour window between each feeding.
Gross, despite describing the precise food composition encompassed by the claims as part of a regimen for the treatment of canine AD, as well as advocating for combining such food treatment with topical cleansing, nevertheless does not specify the use of the particular combination of amphoteric and nonionic surfactants with a polyol set forth by the present claims as a composition for use in such gentle cleansing.
Saridomichelakis indicates that defective skin barrier function has been consistently shown in the skin of dogs afflicted with AD, and advocates that epidermal barrier dysfunction should be assumed in dogs presenting with AD.. (Pg.32-33). Saridomichelakis indicates that oral supplementation with omega fatty acids can be used to treat canine AD, while also indicating that topical shampoo compositions are also advocated for the treatment of canine AD. (Pg.33).
Jiang describes shampoo compositions designed for the treatment of skin sensitized and irritated by allergens to reduce the sensitization and irritation of the skin to which it is applied. (Pg.2). Jiang indicates that these compositions should contain, among others, approximately 16-24% surfactant such as each of the presently claimed cocoamidopropyl betaine and lauryl glycoside, between 2.5-3.1% humectant such as glycerol, skin conditioning agents, and including almond oil as an component of an antiinflammatory agent. (Pg.3). Paye indicates that nonionic surfactants are generally considered the mildest and lead to less irritation when applied to the skin, that anionic surfactants generally are considered irritating, and that amphoteric surfactants are generally used as secondary surfactants, providing a rationale for excluding anionic surfactants per the requirements of Claim 12. (Pg.458). While not specifying the exact concentrations of each of the amphoteric and nonionic surfactants set forth by the instant claims, Jiang does indicate that preferred embodiments of allergen reducing non-irritating shampoo may contain up to 24% surfactant, and that both nonionic and amphoteric surfactants are among the preferred surfactants for use in such shampoos. Combined with the teachings of Paye concerning the use of nonionic surfactants as non-irritating cleansers, and the use of amphoteric surfactants, the skilled artisan is provided with a motivation to employ a greater concentration of nonionic surfactant than that of an amphoteric surfactant in the anti-allergy shampoos of Jiang. While this does advocate a weight ration of nonionic to amphoteric surfactant of greater than 1:1, the particular weight percentages or weight ratios recited by the instant claims are not specifically identified. However, Jiang describes each of cocoamidopropyl betaine and lauryl glycoside as providing surfactant and cleansing properties to the compositions into which they are incorporated. On this basis, a person of ordinary skill in the art would reasonably conclude that the amounts of each are result-effective variables that achieve the results each of the components referred to provide. As such, it would have been routine to optimize the amounts of these components within the total composition suggested by Jiang and Paye to arrive at the concentrations of amphoteric and nonionic surfactants, as well as their respective weight ratios, of the instant claims. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where 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.). Jiang describes an exemplary embodiment whereby the shampoo compositions are applied for 8 minutes, then removed with water, a time period falling within and therefore rendering obvious the limitations of Claim 2. (Pg.12).
It would have been prima facie obvious to one of ordinary skill in the art to have suggested by Jiang and Paye combined the anti-allergy food of Gross with the gentle cleansing shampoo suggested by Jiang and Paye, at least because Gross indicates that gentle cleansing to remove irritants may be combined with the foods described, and that Saridomichelakis indicates that each of fatty acid supplementation and topical cleansers are each advocated for use in the treatment of canine AD. Combined with the Jiang teaching concerning a gentle, anti-allergy and anti-irritant shampooing compositions, the skilled artisan would have had a motivation to utilize the gentle shampoos of Jian as just such a gentle cleanser. Because Gross indicates that the anti-allergy diet should be fed daily, a shampooing will necessarily occur within about 36 hours of a feeding as required by Claim 1.
Claims 1-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gross, Saridomichelakis, Jiang, and Paye as applied to claims 1-15, 17, 18, and 20, above, and further in view of Xu (CN109528588)(Machine translation provided; all references are to the machine translation).
Gross, Saridomichelakis, Jiang, and Paye, discussed in greater detail above, suggest treating AD in canines by combining an anti-allergy food containing each of omega-3, omega-6, and omega-9 fatty acids with quercetin and each of vitamins C and E of Claims 1 and 20, as a composition which provides a ratio of omega-3:omega-6:omega-9 fatty acids of about 0.5:2.0:2.0 with a regimen of gentle washing within 36 hours of having been fed the anti-allergy food a gentle shampoo containing cocoamidopropyl betaine lauryl glycoside, glycerol, a skin conditioning agent, and almond oil in the amounts and concentrations claimed, then removing with water the shampoo after about 8 minutes of its application.
None of Gross, Saridomichelakis, Jiang, or Paye suggest including sodium gluconate in such a shampoo composition.
This is cured by the teachings of Xu, which indicates that shampoos for addressing allergies, itch, and inflammation can incorporate about 1-2% sodium gluconate as a skin conditioning agent. (Pg.1, 3).
It would have been prima facie obvious to have included sodium gluconate as the skin conditioning agent in the gentle shampoo of Jiang, owing to the art-recognized utility of sodium gluconate as such as skin conditioning agent. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Conclusion
No Claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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