DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Preliminary amendment filed on 06/21/2023 has been entered. Claims 3, 5, 7, 9, 11, 12, 14, 16, 17, 23, and 25-46 are cancelled. Claims 1, 2, 4, 6, 8, 10, 13, 15, 18-22, 24, and 47 are pending in this application. Claims 18-22, 24, and 47 are withdrawn. Claims 1, 2, 4, 6, 8, 10, 13, and 15 are currently under examination.
Priority
This application is a 371 of PCT/US2021/064254 filed on 12/19/2021 and claims benefit of US PRO 63/129,325 filed on 12/22/2020.
Election/Restrictions
Applicant's election with traverse of Group I invention (claims 1, 2, 4, 6, 8, 10, 13, 15, and 18-22) and species (A. A food source of oat; B. Caprylic acid (C8) and capric acid (C10) for the two or more medium chain fatty acids and eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) for the omega-3 polyunsaturated acids; and C. Lignin) in the reply filed on 02/05/2026 is acknowledged. The traversal is on the ground(s) that “both Group I and Group II are drawn towards the same category in invention, i.e., pet food compositions. Moreover, the Office has failed to establish any serious burden if restriction were not required… there would be no serious burden to examine at least Groups I and III together… not only is there no serious burden to examine such dependent claims, which are not in fact species of the independent generic claim at all” (p. 2, last 2 paragraphs; p. 3, para. 1 to 2). This is not persuasive because "Groups I/III and II/III are directed to distinct pet food ingredients. Groups I/II are directed to a technical feature: 1-3, 1-6 beta glucan (for example, yeast, disclosed in the Specification) and 1-3, 1-4 beta glucan (for example, oat, disclosed in the Specification), two or more medium chain saturated fatty acids, two or more omega-3 polyunsaturated fatty acids, and betaine. This technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Pan et al. (US 2020/0375934, published on Dec. 3, 2020, also listed in IDS filed on 06/21/2023) as evidenced by PubChem CID 247… Therefore, the technical feature of Groups I/II cannot be a special technical feature over the prior art”, as set forth no pages 4 to 6 of the Restriction/Election Requirement mailed on 12/08/2025. “Lack of unity of invention may be directly evident “ a priori ,” that is, before considering the claims in relation to any prior art, or may only become apparent “ a posteriori ,” that is, after taking the prior art into consideration. For example, independent claims to A + X, A + Y, X + Y can be said to lack unity a priori as there is no subject matter common to all claims. In the case of independent claims to A + X and A + Y, unity of invention is present a priori as A is common to both claims. However, if it can be established that A is known, there is lack of unity a posteriori, since A (be it a single feature or a group of features) is not a technical feature that defines a contribution over the prior art.“ (see MPEP § 1850 [R-01.2024], 37 CFR 1.475, II). Furthermore, as indicated in MPEP, only independent claims are considered.
Claims 18-22, 24, and 47 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Thus, claims 1, 2, 4, 6, 8, 10, 13, and 15 are currently under examination.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
Three information disclosure statements (IDS) filed on 06/21/2023, 07/17/2024, and 01/13/2025 have been considered.
Claim Objections
Claims 1 and 10 are objected to because of the following informalities: In claim 1, change the incorrect recitation “saturated fatty acids; two or more omega-3” (lines 5 to 6) to “saturated fatty acids and two or more omega-3” because the conjunction “and” is required to obtain “a total amount of about 0.5% or more” (lines 6 to 7), and to comply with the disclosure in the specification and the limitation in claim 8. In claim 10, insert the missing phrase “fatty acids” immediately after the recitation “C8 and C10” (line 2). Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 4, 6, 8, 10, 13, and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon or a product of nature without significantly more. The 2019 Revised Patent Subject Matter Eligibility Guidance (issued January 7, 2019)” (https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf) and “October 2019 Update: Subject Matter Eligibility (issued October 17, 2019)” (https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf), are followed here. The claim is directed to a statutory category, e.g., a composition of matter (Step 1: YES). The claim is then analyzed in Step 2A (Prong one) to determine whether it is directed to any judicial exception. The claims 1, 2, 4, 6, 8, 10, 13, and 15 recite a composition comprising 1-3, 1-6 beta glucan (for example, yeast, disclosed in the Specification) and 1-3, 1-4 beta glucan (for example, oat, disclosed in the Specification); two or more medium chain saturated (or C8 and C10) fatty acids and two or more omega-3 polyunsaturated (or EPA and DHA) fatty acids; and betaine (or further comprising lignin), which are products of nature. Accordingly, the claim is directed to at least one exception (Step 2A, prong one: YES). The claim is then analyzed in Step 2A (Prong two) and is determined that this judicial exception is not integrated into a practical application because there is no indication that mixing them in the recited weight ratio (i.e., equal to about 0.8% or more, wherein the 1-3, 1-4 beta glucan is about 83% or more, by weight, of the two beta glucans; a total amount of about 0.5% or more, wherein the two or more medium chain saturated fatty acids are at least 36%, by weight, of these fatty acids; about 0.5% or more betaine) changes the structure, function, or other properties of the 1-3, 1-6 beta glucan and 1-3, 1-4 beta glucan; two or more medium chain saturated (or C8 and C10) fatty acids and two or more omega-3 polyunsaturated (or EPA and DHA) fatty acids; betaine; or lignin in any marked way. Instead, they retain naturally occurring structures and properties (e.g., dietary fiber activity or hydrophobic substance). Thus, the claimed mixture as a whole does not display markedly different characteristics compared to the closest naturally occurring counterpart. Accordingly, the Step 2A (Prong two) is NO. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because prior to applicant’s invention and at the time of filing the application, mixing of the 1-3, 1-6 beta glucan and 1-3, 1-4 beta glucan; two or more medium chain saturated (or C8 and C10) fatty acids and two or more omega-3 polyunsaturated (or EPA and DHA) fatty acids; betaine; and lignin was well-understood, routine and conventional in the field, as evidenced by the reference under the 102 or 103 rejection below. The recitation of specific weight ratio does not affect this analysis, because it was also well-understood, routine and conventional at the time to mix specific weight ratio, e.g., to achieve commercially acceptable composition for different purposes. Thus, the mixing of different weight ratios, when recited at this high level of generality, does not meaningfully limit the claim, and the claim as a whole does not amount to significantly more than each “product of nature” by itself (Step 2B: NO). The claim does not qualify as eligible subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4, 6, 8, 10, 13, and 15 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Jewell et al. (US 2020/0239941, Jul. 30, 2020, filed on Dec.18, 2019, hereinafter referred to as Jewell ‘941) as evidenced by Captex 355 (Captex® 355 Medium-Chain Triglycerides, accessed on 03/14/2026) and Patterson et al. (https://www.ars.usda.gov/ARSUserFiles/80400535/Data/Choline /Choln02.pdf, January 2008, hereinafter referred to as Patterson ‘2008).
With regard to structural limitations “1-3, 1-6 beta glucan (for example, yeast, disclosed in the Specification) and 1-3, 1-4 beta glucan (oat, elected) present in a total amount equal to about 0.8% or more (or about 0.8% to about 5%), based on the weight of the pet food composition, wherein the 1-3, 1-4 beta glucan is about 83% or more (or from 83% to 95%), by weight, of the two beta glucans; two or more medium chain saturated fatty acids (or C8 caprylic acid and C10 capric acid) and two or more omega-3 polyunsaturated fatty acids (or EPA and DHA) present in a total amount of about 0.5% or more (or from about 0.5% to about 7%), based on the weight of the pet food composition, wherein the two or more medium chain saturated fatty acids are at least 36% (from about 36% to about 60%), by weight, of these fatty acids; and betaine present in an amount of about 0.5% or more (or about 0.5% to about 2%, or further comprising lignin, exemplified as pecan in the Specification, in an amount of at least 1.25 %)” (claims 1, 2, 4, 6, 8, 10, 13, and 15):
Jewell ‘941 disclosed a pet or cat daily diet. Table 4 describes ingredients used in certain
embodiments:
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661
484
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, in which weight ratio of oat bran/(oat bran + yeast) is 94.3% to 97.6% and that of Captex 355/(Captex 355+ Fish oil) is about 66.7%; and betaine also presents in other ingredients, including chicken livers, beet, and oat. Table 5 describes ingredients used in certain embodiments:
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831
413
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, in which weight ratio of oat bran/(oat bran + yeast) is up to 95.2%, and that of Captex 355/(Captex 355+ Fish oil) is up to 72.7%; and betaine also presents in other ingredients, including chicken livers, beet, and oat (page 21/27, [0165-0167]). Captex 355 (cited here as evidence only) disclosed Fatty Acid Composition of Captex 355 Medium-Chain Triglycerides:
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200
400
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(pages 1/9 and 6/9) . Patterson ‘2008 (cited here as evidence only) disclosed USDA Database for the Choline Content of Common Foods: betaine (mg/100g food) in chicken livers (13.0 to 21.0), beet (130.0 to 260.0), and oat bran (20.0 to 36.0) (pages 15/37, 21/37, and 31/37).
Thus, these teachings of Jewell ‘941 anticipate Applicant’s claims 1, 2, 4, 6, 8, 10, 13, and 15.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned 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, 2, 4, 6, 8, 10, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Jewell (US 2016/0287543, hereinafter referred to as Jewell ‘543) in view of Gebreselassie et al. (CURRENT DEVELOPMENTS IN NUTRITION, Abstract P11-002, Published online June 28, 2018, hereinafter referred to as Gebreselassie ‘2018) and O’Sullivan et al. (US 2016/0029627, Feb. 4, 2016, hereinafter referred to as O’Sullivan ‘627).
With regard to structural limitations “1-3, 1-6 beta glucan (for example, yeast, disclosed in the Specification) and 1-3, 1-4 beta glucan (oat, elected) present in a total amount equal to about 0.8% or more (or about 0.8% to about 5%), based on the weight of the pet food composition, wherein the 1-3, 1-4 beta glucan is about 83% or more (or from 83% to 95%), by weight, of the two beta glucans; two or more medium chain saturated fatty acids (or C8 caprylic acid and C10 capric acid) and two or more omega-3 polyunsaturated fatty acids (or EPA and DHA) present in a total amount of about 0.5% or more (or from about 0.5% to about 7%), based on the weight of the pet food composition, wherein the two or more medium chain saturated fatty acids are at least 36% (from about 36% to about 60%), by weight, of these fatty acids; and betaine present in an amount of about 0.5% or more (or about 0.5% to about 2%, or further comprising lignin, for example, hulls of grains, in an amount of at least 1.25 %)” (claims 1, 2, 4, 6, 8, 10, 13, and 15):
Jewell ‘543 disclosed a pet Food comprising EPA and DHA, added carnitine, added MCT (medium chain fatty acid having 6 to 14 carbon atoms, e.g., caproic acid, caprylic acid, capric acid, lauric acid, or myristic acid) oil and added n-6 fatty acids for improving renal function. See Table 4:
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665
528
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. eSum of the saturated fatty acids: 8:0 + 10:0 + 11:0 + 12:0 + 14:0 + 15:0 + 16:0 + 17:0 + 18:0 + 20:0 + 22:0 + 24:0. The weight ratio of MCT/(MCT + EPA +DHA) is 54.0 % (= 0.2/0.37) for test food 1 and 78.8% (= 1.45/1.84) for test food 2. A nutritionally balanced composition for pet is palatable and, together with water, provides the sole source of all of the nutrition necessary for maintenance of normal health. For example, dog food may contain protein, fat, carbohydrate, dietary fiber, amino acids, minerals, vitamins, and other ingredients. The compositions typically contain at least about 4% (or from about 4% to about 50%, or from about 8% to about 25%, or from about 15% to about 22%) total fat. Dietary fiber refers to components of a plant which are resistant to digestion by an animal's digestive enzymes. Crude fiber includes indigestible components contained in cell walls and cell contents of plants such as grains, e.g., hulls of grains such as rice, corn, and beans. Typical fiber amounts in the composition are from about 0 to about 10%, or from about 1% to about 5% (page 20/21, Table 4; page 2/21, [0024]; page 3/21, [0026, 0029, and 0032]).
Jewell ‘543 did not explicitly disclose the limitations (a) 1-3, 1-4 beta glucan (oat, elected) and betaine present in an amount of about 0.5% or more (or about 0.5% to about 2%), and (b) 1-3, 1-6 beta glucan (for example, yeast, disclosed in the Specification), required by claims 1, 2, and 13.
With regard to structural limitation (a) above, Gebreselassie ‘2018 disclosed a cat or pet food contained betaine, short-chain fructo-oligosaccharides (scFOSs), and long-chain oat β-glucan. The studies suggest a strong benefit of using betaine and fermentable fibers to minimize the accumulation of uremic toxins, and to improve body conditions and overall health in renal cats (page 7/12, right col.).
With regard to structural limitation (b) above, O’Sullivan ‘627 disclosed that ß-(1,3) glucans are a naturally occurring class of polysaccharides found in many species of yeast (including Baker's Yeast or S. cerevisiae), mushrooms, plants (including cereals) and some bacterial, lichen and algal species. The beta glucans isolated from cereal sources (like wheat, barley and oats) are linear homopolysaccharides (of glucose) with approximately 70% (1,4)-linkages and 30% (1,3)-linkages, while the glucans isolated from yeast consist predominantly of ß-(1,3) glucan chains with ß-(1,6) branching as well as a small incidence of ß-(1,6) linked chains. Algal ß-glucans, called laminarin, consist of ß-(1,3)-D-glucan with occasional (1,6) linked branches. Two individual constituents of the compositions, glucan and/or fucan, have been isolated and are used as dietary feed additives to enhance animal health; and as dietary Supplements in animals and humans (pages 14/32 to 15/32, [0122 to 0123]; page 11/32, [0081]).
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to substitute the L-carnitine and generic dietary fibers as taught by Jewell ‘543 with betaine and ß-glucans (1,3/1,4 ß-glucan plus 1,3/1,6 ß-glucan), respectively, in view of Gebreselassie ‘2018 and O’Sullivan ‘627, followed by optimization of weight ratios to improve renal function in pets because 1,3/1,4 ß-glucan (e.g. oat) plus 1,3/1,6 ß-glucan (e.g. yeast cell wall), widely used as dietary feed additives to enhance animal health, betaine, medium chain saturated and omega-3 polyunsaturated fatty acids, and hulls of grains are required ingredients to improve renal function in dog and cat, described above. Thus, one of skill in the art would have a reasonable expectation that by substituting the L-carnitine and generic dietary fibers as taught by Jewell ‘543 with betaine and ß-glucans (1,3/1,4 ß-glucan plus 1,3/1,6 ß-glucan), respectively, in view of Gebreselassie ‘2018 and O’Sullivan ‘627, followed by optimization of weight ratios to improve renal function in pets, one would achieve Applicant’s claims 1, 2, 4, 6, 8, 10, 13, and 15. "Exemplary rationales that may support a conclusion of obviousness include: (B) Simple substitution of one known element for another to obtain predictable results". See MPEP § 2143 [R-01.2024] [I]. "[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 [R-01.2024] [II.A].
Conclusion
No claims are allowed.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691