Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This action is in response to Applicant’s amendment filed January 29, 2026 in reply to the Non-final Office Action mailed November 13, 2025. Claim 17 has been amended; and claims 1-16, 19, 20, and 34 have been canceled. Claims 17, 18, and 21-34 are now pending in the application. Claims 17, 18, and 21-33 are currently under examination.
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.
Claims 17, 18, and 21-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 first provides that the method is for “treating an inflammatory disease, disorder or condition”, and then stipulates in a wherein clause that “the method reduces basal inflammation and enhances acute inflammation”, which renders the claim indefinite for the following reasons:
1. First, as anyone of ordinary skill in the art would readily know, a healthy canine will have a basal level of inflammation. Without any doubt, a basal level of inflammation is not an inflammatory disease or disorder, but rather can be a necessity for health in a normal canine by e.g. fighting off infections and helping repair tissues. Hence, by “reducing basal inflammation”, one can in effect weaken the immune system and hinder its ability to perform essential, healthy functions. In effect, this would appear induce an inflammatory disease or disorder. Further, by “enhancing acute inflammation”, one can exacerbate the inflammatory imbalance and/or introduce another inflammatory disease or disorder. Hence, the claimed method on the one hand requires treating an inflammatory disease, disorder, or condition, but then appears on the other hand to provide for triggering or exasperating an inflammatory disease, disorder, or condition. As one of ordinary skill in the art would recognize, this is incongruous. Hence, one of ordinary skill in the art cannot make heads or tails out of the claimed subject matter.
2. Even assuming, arguendo, that “basal inflammation” and “acute inflammation” do in fact fall under the purview of “inflammatory disease, disorder, or condition”, without question, anyone of ordinary skill in the art would recognize that “an inflammatory disease, disorder, or condition” is far broader in scope than “basal inflammation” and/or “acute inflammation”. Hence, even if “reducing basal inflammation” and/or “enhancing acute inflammation” somehow fall under the purview of “treating an inflammatory disease, disorder, or condition”, one of ordinary skill in the art cannot definitively ascertain whether “treating an inflammatory disease, disorder, or condition” is necessarily limited exclusively to reducing basal inflammation and enhancing acute inflammation, or rather whether these effects are mere examples of what could occur. If “treating an inflammatory disease, disorder, or condition” is necessarily limited exclusively to reducing basal inflammation and enhancing acute inflammation, one of ordinary skill in the art cannot definitively ascertain whether the claim simultaneously requires both “reducing basal inflammation” and “enhancing acute inflammation”, or rather whether the claim is limited to either “reducing basal inflammation” or “enhancing acute inflammation”, or what.
***Claim 17 is being interpreted as the method results in at least one of reducing basal inflammation and/or enhancing acute inflammation.
Claims 18 and 21-33 are indefinite for depending from an indefinite claim.
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 17, 18, and 21-33 are rejected under 35 U.S.C. 103 as being unpatentable over Middleton et al. (U.S. Patent Application Pub. No. 2018/0168197), in view of Luyer et al. (U.S. Patent Application Pub. No. 2008/0108548).
Applicant Claims
Applicant claims a method for treating an inflammatory disease, disorder, or condition in a canine in need thereof comprising administering to the canine a composition comprising 1,500-7,000 ppm by mass of betaine and 100-700 ppm by mass of carnitine; wherein the mass ratio of betaine to carnitine is 25:1 to 8:1; wherein the said composition being administered is “wet” or “dry”; wherein the said composition being administered further comprises an “anti-inflammatory adjuvant” selected from curcumin, clove, ginger, rosemary, paprika, and “a berry”; and wherein the said composition being administered further comprises an additional ingredient selected from a vitamin, a mineral, a carbohydrate, a protein, a fat, a fiber, an amino acid, a carotinoid, an antioxidant, a fatty acid, a “glucose mimetic”, a probiotic, a prebiotic, or a combination thereof.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Middleton et al. disclose a pet food composition for e.g. a dog, which can be “wet” or “dry”, comprising carbohydrate, protein, fat, fiber, and one or more metabolites; wherein the metabolites can be e.g. betaine and carnitine; wherein the betaine can be present in the amount of e.g. 0.61 wt% (i.e. 6100 ppm); and wherein the composition can further comprise e.g. clove and ginger (see e.g. paragraphs 0007, 0023, 0031, 0032, 0055, 0058-0062, 0071, 0074, 0075, 0078; Tables 3, 7, 15, 19, and 23).
Luyer et al. disclose that a pet food composition for e.g. a dog, which can be “wet” or “dry”, comprising carbohydrate, protein, fat, fiber, and further comprising e.g. 0.5-5 wt% betaine and 0.1-2 g/L (i.e. 0.01-0.2 g/100 mL, or 0.01-2 wt%) carnitine can treat, prevent, or ameliorate a symptom associated with an inflammatory disease, disorder, or condition (see, for example, abstract; paragraphs 0001, 0013, 0015, 0021, 0028-0030, 0033-0036, 0041).
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Middleton et al. do not explicitly disclose that the carnitine amount is e.g. 50-700 ppm; that the mass ratio of betaine to carnitine is about 25:1 to 8:1; and that the composition treats, prevents, or ameliorates a symptom associated with an inflammatory disease, disorder, or condition. These deficiencies are cured by the teachings of Luyer et al.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Middleton et al. and Luyer et al., outlined supra, to devise Applicant’s presently claimed composition and method.
Middleton et al. disclose a dog food composition comprising carbohydrate, protein, lipid, fiber, and select metabolites, e.g. betaine and carnitine; wherein the betaine can be present in the amount of e.g. 0.61 wt% (i.e. 6100 ppm); and wherein the composition can further comprise e.g. clove and ginger. Since Luyer et al. disclose that a dog food composition comprising carbohydrate, protein, lipid, fiber, and further comprising e.g. 0.5-5 wt% betaine and 0.1-2 g/L (i.e. 0.01-0.2 g/100 mL, or 0.01-2 wt%) carnitine can treat, prevent, or ameliorate a symptom associated with an inflammatory disease, disorder, or condition; one of ordinary skill in the art would thus be motivated to include e.g. about 0.61 wt% betaine (i.e. 6100 ppm) and 0.01-0.2 wt% carnitine (i.e. 100-2000 ppm), with the reasonable expectation that the resulting dog food composition when orally administered to a dog, can successfully treat, prevent, or ameliorate a symptom associated with an inflammatory disease, disorder, or condition.
With 6100 ppm betaine and 100-2000 ppm carnitine, the mass ratio of betaine to carnitine would thus be about 61:1 to about 3:1.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed January 29, 2026 have been fully considered but they are not persuasive.
i) Applicant contends that “Luyer focuses only on reducing an inflammatory response”; that “both Middleton and Luyer are completely silent with respect to reducing basal inflammation while also increasing acute inflammation”; that “the combination of betaine and carnitine synergistically reduced basal inflammation, which is a desirable effect in animals with inflammation, while simultaneously enhancing acute inflammation, which is a desirable effect in animals fighting an infection”; and that “as shown in Table 2, carnitine alone served to increase unstimulated cytokine (i.e. basal inflammation), while the addition of betaine completely reversed this effect” by reducing “the unstimulated cytokines to an even greater extent than betaine alone and also to increase LPS-stimulated cytokines”.
The Examiner, however, would like to point out the following:
1. The present claims are directed to “a method of treating an inflammatory disease, disorder, or condition”, not directed to a method of treating an infection. There need not necessarily be any “LPS-stimulated cytokines” as there need not be any LPS, i.e. from the presence of an infection.
2. Luyer discloses that a pet food composition for e.g. a dog, which can be “wet” or “dry”, comprising carbohydrate, protein, fat, fiber, and further comprising e.g. 0.5-5 wt% betaine and 0.1-2 g/L (i.e. 0.01-0.2 g/100 mL, or 0.01-2 wt%) carnitine can treat, prevent, or ameliorate a symptom associated with an inflammatory disease, disorder, or condition. Without question, it would be obvious to treat an inflammatory disease, disorder, or condition in a canine by administering a dog food composition comprising carbohydrate, protein, fat, fiber, and further comprising e.g. 0.5-5 wt% betaine and 0.1-2 g/L (i.e. 0.01-0.2 g/100 mL, or 0.01-2 wt%) carnitine.
3. Both Middleton and Luyer disclose dog food compositions that can contain both betaine and carnitine. Applicant’s dog food composition contains 700-10,000 ppm betaine and 50-700 ppm carnitine. Luyer’s dog food composition, which can treat an inflammatory disease, disorder, or condition, can contain e.g. 0.5-5 wt% betaine and 0.1-2 g/L (i.e. 0.01-0.2 g/100 mL, or 0.01-2 wt%) carnitine, i.e. 5,000-50,000 ppm betaine and 100-20,000 ppm carnitine. The values for betaine and carnitine are not patentably distinct from the claimed values. Since e.g. Luyer discloses that both betaine and carnitine can both be present, and in amounts not patentably distinct from the claimed amounts, and that the composition treats an inflammatory disease, disorder, or condition, it can reasonably be assumed that the combination of betaine and carnitine in Luyer has the same synergistic effect. In other words, Applicant has merely identified a property of the Luyer composition.
4. Moreover, the method one of ordinary skill in the art would arrive at by following the teachings and reasonable suggestions of the cited prior art would thus involve administering the dog food containing e.g. betaine and carnitine in the requisite amounts, and that this composition would be administered to a subject with an inflammatory disease, disorder or condition to thus treat the inflammatory disease, disorder, or condition, it must therefore follow that the method one of ordinary skill in the art would thus arrive at would e.g. reduce basal inflammation, even if the cited prior art did not disclose this verbatim.
5. The claims are much broader in scope than the data of Table 2. It is also noted that the data of Table 2 does not properly establish superior and unexpected results for the treatment of any specific inflammatory disease, disorder, or condition. For example, the data of Table 2 does not properly establish that the combination of the claimed amounts of betaine and carnitine have a synergistic effect in treating e.g. distemper, or e.g. rabies, or e.g. arthritis. Applicant has merely shown an effect on certain select cytokine levels.
For the foregoing reasons, the 35 USC 103 rejection is hereby maintained.
Conclusion
No claims are allowed.
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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617