DETAILED ACTION
Response to Amendment
Applicant’s response to the office action filed on December 17, 2025 has been entered. The claims pending in this application are claims 1-27 wherein claims 10, 12, 13, and 15-27 have been withdrawn due to the restriction requirement in the office action mailed on May 27, 2025. The objections and rejections not reiterated from the previous office action are hereby withdrawn in view of applicant’s amendment filed on May 27, 2025. Claims 1-9, 11, and 14 will be examined.
Claim Objections
Claim 1 is objected to because of the following informality: “is detected” in the last line should be “are detected”.
Claim 3 or 14 is objected to because of the following informality: “in a feline subject” in the “analyzing step” should be “in the feline subject”.
Appropriate correction is required.
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.
New Matter
Claims 1-9 and 11 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
A limitation “administering to the feline subject a composition comprising an effective amount of a pet food composition to delay onset or reduce severity of cat kidney disease, when the presence of one or 2 copies of the minor allele of one or more single nucleotide polymorphisms selected from the group consisting of SNP A3 117040611, SNP A3 117041908 and SNP A3 117081913 and a single nucleotide polymorphism in linkage disequilibrium with one or more thereof is detected” is added to independent claim 1 and a limitation “administering to the feline subject identified as having an increased likelihood of developing cat kidney disease a composition comprising an effective amount of a pet food composition to delay onset or reduce severity of cat kidney disease” is added to independent claim 3. Although the specification describes that “[C]hronic renal disease (chronic kidney disease, CKD) is a common affliction of aging cats with a prevalence rate of 1-3% in all cats and up to 80% of geriatric cats”, “2PY can be used as a biomarker for renal disease in cats. In humans, N-methyl-2-pyridone-5-carboxamide (2PY), which is a metabolite of nicotinic acid (Niacin, Vitamin B3), has been designated as a uremic toxin which additionally may exacerbate kidney tissue damage through its inhibition of poly ADP-ribose polymerase 1 (PARP-1). PARP-1 is thought to detect DNA damage and initiate DNA repair mechanisms and its inhibition may lead to apoptosis and cell death. Nicotinamide is the water-soluble amine derivative of nicotinic acid. Nicotinamide is methylated to N-methyl-nicotinamide which is then converted into either 2PY or N-methyl-4-pyridone-5-carboxamide (4PY) by aldehyde oxidase (AOX) (EC Number 1.2.3.1)”, “2PY levels were found to be elevated in cats having CKD. Accordingly, measuring 2PY levels in cats that present as being healthy, including those considered to be at a higher risk for CKD, can be performed as part of a general screening procedure. Measured 2PY levels in such cats can be compared to a standard level that is representative of 2PY levels in cats without disease and a finding of elevated 2PY levels indicates that the cat is likely to have renal disease. 2PY can also be used to evaluate cats suspected as having renal disease, i.e., demonstrating some symptoms of renal disease as well as to confirm the presence of disease in cats who have been diagnosed as having renal disease. Additionally, 2PY has been found in short term studies to be more sensitive than the commonly used biomarker, creatinine, for demonstrating efficacy of dietary and other interventions. Thus, 2PY allows for improved ability to monitor response to treatment as well as to improve the ability to develop more efficacious interventions at a faster pace. Two different formulations have been developed that effectively reduce the 2PY levels of both normal and renal cats”, “[L]evels of 2PY may be measured in blood samples. Blood is collected in order to determine plasma metabolomic profiles”, and diet 1 supplemented with 0.5% betaine, 0.586% oat beta glucan and 0.047% short-chain fructo-oligosaccharide and diet 2 supplemented with 0.5% betaine, 0.586% oat beta glucan and 3.44% apple pomace significantly reduce plasma levels of 2PY in cats having CKD (see paragraphs [0004], [0045] to [0047], [0126], and [0127], Tables 5 and 6 of US 2023/0151410 A1, which is US application of this instant application), paragraphs [0012], [0013], [0049] to [0057], [0082], [0087], and [0123] of the specification suggested by applicant do not describe such limitations recited in claims 1 and 3 since the specification only describes that diet 1 supplemented with 0.5% betaine, 0.586% oat beta glucan and 0.047% short-chain fructo-oligosaccharide and Diet 2 supplemented with 0.5% betaine, 0.586% oat beta glucan and 3.44% apple pomace significantly reduce plasma levels of 2PY in cats having CKD and does not describe other pet food composition which can delay onset or reduce severity of cat kidney disease.
MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” MPEP 2163.02 teaches that “Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed...If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application.” MPEP 2163.06 further notes “When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not “new matter” is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure” (emphasis added).
Scope of Enablement
Note that the rejection is different from the rejection under 35 U.S.C. 112(a) mailed on September 3, 2025.
Claims 1-9, 11, and 14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for detecting the presence of one copy or 2 copies of a minor allele of one or more single nucleotide polymorphisms selected from the group consisting of SNP A3_ 117040611, SNP A3_ 117041908 and SNP A3_ 117081913 in a feline subject and identifying whether a feline subject has an increased likelihood of developing cat kidney disease when genotype G/G in a polymorphism SNP A3_ 117040611 in the feline subject changes to genotype A/G or genotype G/G in a polymorphism SNP A3_ 117081913 in the feline subject changes to genotype A/G or A/A, does not reasonably provide enablement for performing the methods recited in claims 1-9, 11, and 14. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988). Wands states at page 1404,
“Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.”
The Nature of The Invention
The claims are drawn to a method of detecting the presence of one copy or 2 copies of a minor allele of one or more single nucleotide polymorphisms selected from the group consisting of SNP A3_ 117040611, SNP A3_ 117041908 and SNP A3_ 117081913 and a single nucleotide polymorphism in linkage disequilibrium with one or more thereof in a feline subject and a method of identifying whether a feline subject has an increased likelihood of developing cat kidney disease. The invention is a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology.” Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
The Breadth of The Claims
Claims 1 and 2 encompass a method of detecting the presence of one copy or 2 copies of a minor allele of one or more single nucleotide polymorphisms selected from the group consisting of SNP A3_ 117040611, SNP A3_ 117041908 and SNP A3_ 117081913 and a single nucleotide polymorphism in linkage disequilibrium with one or more thereof in a feline subject, the method comprising: obtaining a biological sample from the feline subject; analyzing the biological sample to detect one copy or 2 copies of a minor allele of one or more single nucleotide polymorphisms selected from the group consisting of SNP A3_117040611, SNP A3_117041908 and SNP A3_117081913 and a single nucleotide polymorphism in linkage disequilibrium with one or more thereof, wherein the single nucleotide polymorphism in linkage disequilibrium is selected from SNP A3_117040611, SNP A3_117041908, and SNP A3_ 117081913; and administering to the feline subject a composition comprising an effective amount of a pet food composition to delay onset or reduce severity of cat kidney disease, when the presence of one or 2 copies of the minor allele of one or more single nucleotide polymorphisms selected from the group consisting of SNP A3_117040611, SNP A3_117041908 and SNP A3_117081913 and a single nucleotide polymorphism in linkage disequilibrium with one or more thereof are detected. Claims 3-9 and 11 encompass a method of identifying whether a feline subject has increased likelihood of developing cat kidney disease comprising: obtaining a biological sample from the feline subject; analyzing the biological sample for the presence of one copy or 2 copies of a minor allele of two or more single nucleotide polymorphisms selected from the group consisting of SNP A3_ 117040611, SNP A3_ 117041908 and SNP A3_ 117081913 and a single nucleotide polymorphism in linkage disequilibrium with one or more thereof in a feline subject; wherein the single nucleotide polymorphism in linkage disequilibrium is selected from SNP A3_117040611, SNP A3_117041908, and SNP A3_117081913; and administering to the feline subject identified as having an increased likelihood of developing cat kidney disease a composition comprising an effective amount of a pet food composition to delay onset or reduce severity of cat kidney disease; wherein the presence of one copy or 2 copies of the minor allele of two or more single nucleotide polymorphisms selected from the group consisting of SNP A3_ 117040611, SNP A3_ 117041908 and SNP A3_ 117081913 indicates that the feline subject has an increased likelihood of developing cat kidney disease within its lifetime. Claim 14 encompasses a method of identifying whether a feline subject has an increased likelihood of developing cat kidney disease (CKD) comprising: obtaining a biological sample from the feline subject; analyzing the biological sample for the presence of one copy or 2 copies of a minor allele of two or more single nucleotide polymorphisms selected from the group consisting of SNP A3 117040611, SNP A3 117041908 and SNP A3 117081913 and a single nucleotide polymorphism in linkage disequilibrium with one or more thereof in a feline subject, wherein the single nucleotide polymorphism in linkage disequilibrium is selected from SNP A3_117040611, SNP A3_117041908, and SNP A3_117081913, wherein the sample is analyzed by performing DNA sequencing, restriction enzyme digest, polymerase chain reaction (PCR), hybridization, real-time PCR, reverse transcriptase PCR, or ligase chain reaction, and wherein the presence of one copy or 2 copies of the minor allele of two or more single nucleotide polymorphisms selected from the group consisting of SNP A3_117040611, SNP A3_117041908 and SNP A3_ 117081913 indicates that the feline subject has an increased likelihood of developing cat kidney disease within its lifetime; and administering to the feline subject identified as having an increased likelihood of developing cat kidney disease a composition comprising an effective amount of a pet food composition to delay onset or reduce severity of cat kidney disease, wherein the administering comprises feeding the feline subject a diet that comprises effective amounts of betaine, oat beta glucan, one or more of short-chain fructo-oligosaccharide, and apple pomace; wherein the method further comprises monitoring the health of the feline subject comprising: quantifying at two or more time points the level of 2PY present in a blood sample from the feline wherein an elevation of 2PY levels over time indicates that the feline subject is developing kidney disease.
Working Examples
Although the specification provides 3 working examples (see pages 12-14 of US 2023/0151410 A1, which is US publication of this instant case), the specification provides no working example for the methods recited in claims 1-9, 11, and 14.
The Amount of Direction or Guidance Provided and The State of The Prior Art
The specification provides 3 working examples (see pages 12-14 of US 2023/0151410 A1, which is US publication of this instant case). However, the specification provides no working example for the methods recited in claims 1-9, 11, and 14. Furthermore, there is no experimental condition and/or experimental data in the specification to support the claimed invention. During the process of the prior art search, the examiner has not found any prior art which is related to the methods recited in claims 1-9, 11, and 14.
Level of Skill in The Art, The Unpredictability of The Art, and The Quantity of Experimentation Necessary
While the relative skill in the art is very high (the Ph.D. degree with laboratory experience), there is no predictability whether the methods recited in claims 1-9, 11, and 14 can be performed.
Since Example 2 of the specification teaches that SNPs A3_117041908 and A3_117081913 are linked, SNP A3_117040611 is an independent locus based on a linking analysis, and the level of N-methyl-2-pyridone-5-carboxamide (2PY) in serum of a feline subject is increased when genotype G/G in a polymorphism SNP A3_ 117040611 in the feline subject changes to genotype A/G or genotype G/G in a polymorphism SNP A3_ 117081913 in the feline subject changes to genotype A/G or A/A, and 2PY can be used as a biomarker for renal disease in cats (see paragraphs [0045], [0121] to [0124], and Tables 3 and 4 of US 2023/0151410 A1, which is US publication of this instant case), the specification clearly indicates that a feline subject has an increased likelihood of developing cat kidney disease when genotype G/G in a polymorphism SNP A3_ 117040611 in the feline subject changes to genotype A/G or genotype G/G in a polymorphism SNP A3_ 117081913 in the feline subject changes to genotype A/G or A/A. Since the specification and available art do not indicate that the level of N-methyl-2-pyridone-5-carboxamide (2PY) in serum of a feline subject is correlated with a polymorphism SNP A3_ 117041908, a feline subject having one or 2 copies of the minor allele of a single nucleotide polymorphism SNP A3_117041908 or a feline subject having one or 2 copies of the major allele of single nucleotide polymorphism SNP A3_ 117040611 or a feline subject having one or 2 copies of the major allele of single nucleotide polymorphism SNP A3_ 117081913 does not have increased likelihood of developing cat kidney disease such that it is unclear why the feline subject is required to be administered a composition comprising an effective amount of a pet food composition to delay onset or reduce severity of cat kidney disease when the presence of one or 2 copies of the minor allele of a single nucleotide polymorphism SNP A3_117041908 and a single nucleotide polymorphism SNP A3_ 117041908 in linkage disequilibrium are detected as recited in claim 1. Furthermore, although Example 3 of the specification teaches that diet 1 supplemented with 0.5% betaine, 0.586% oat beta glucan and 0.047% short-chain fructo-oligosaccharide and diet 2 supplemented with 0.5% betaine, 0.586% oat beta glucan and 3.44% apple pomace significantly reduce plasma levels of 2PY in cats (see paragraphs [0126] and [0127], and Table 6 of US 2023/0151410 A1, which is US publication of this instant case), since the specification and available arts do not show that, besides diet 1 supplemented with 0.5%
betaine, 0.586% oat beta glucan and 0.047% short-chain fructo-oligosaccharide and diet 2 supplemented with 0.5% betaine, 0.586% oat beta glucan and 3.44% apple pomace, which other pet food composition or a diet that comprises effective amounts of betaine, oat beta glucan, one or more of short-chain fructo-oligosaccharide, and apple pomace can delay onset or reduce severity of cat kidney disease, without undue experimentations, how a skilled artisan knows that which other pet food composition or the diet that comprises effective amounts of betaine, oat beta glucan, one or more of short-chain fructo-oligosaccharide, and apple pomace can delay onset or reduce severity of cat kidney disease such that it is unclear why the feline subject is required to be administered a composition comprising an effective amount of any kind of pet food composition to delay onset or reduce severity of cat kidney disease when the presence of one or 2 copies of the minor allele of one or more single nucleotide polymorphisms selected from the group consisting of SNP A3_117040611, SNP A3_117041908 and SNP A3_ 117081913 and a single nucleotide polymorphism in linkage disequilibrium with one or more thereof are detected as recited in claims 1 and 2, why the feline subject identified as having an increased likelihood of developing cat kidney disease is required to be administered a composition comprising an effective amount of any kind of pet food composition to delay onset or reduce severity of cat kidney disease as recited in claims 3-9 and 11, and why the feline subject identified as having an increased likelihood of developing cat kidney disease is required to be administered a diet that comprises effective amounts of betaine, oat beta glucan, one or more of short-chain fructo-oligosaccharide, and apple pomace.
Case law has established that “(t)o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright 990 F.2d 1557, 1561. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) it was determined that “[T]he scope of the claims must bear a reasonable correlation to the scope of enablement provided by the specification to persons of ordinary skill in the art”. The amount of guidance needed to enable the invention is related to the amount of knowledge in the art as well as the predictability in the art. Furthermore, the Court in Genentech Inc. v Novo Nordisk 42 USPQ2d 1001 held that “[I]t is the specification, not the knowledge of one skilled in the art that must supply the novel aspects of the invention in order to constitute adequate enablement”.
In view of above discussions, the skilled artisan will have no way to predict the experimental results. Accordingly, it is concluded that undue experimentation is required to make the invention as it is claimed. The undue experimentation at least includes to test whether the methods recited in claims 1-9, 11, and 14 can be performed.
Conclusion
In the instant case, as discussed above, the level of unpredictability in the art is high, the specification provides one with no guidance that leads one to claimed methods. One of skill in the art cannot readily anticipate the effect of a change within the subject matter to which the claimed invention pertains. Thus given the broad claims in an art whose nature is identified as unpredictable, the unpredictability of that art, the large quantity of research required to define these unpredictable variables, the lack of guidance provided in the specification, the absence of any working example related to claimed invention and the no teaching in the prior art balanced only against the high skill level in the art, it is the position of the examiner that it would require undue experimentation for one of skill in the art to perform the method of the claim as broadly written.
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 14 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.
Claim 14 is rejected as vague and indefinite in view of the administering step because it is unclear whether a diet that comprises effective amounts of betaine, oat beta glucan, one or more of short-chain fructo-oligosaccharide, and apple pomace is a part of a composition comprising an effective amount of a pet food composition to delay onset or reduce severity of cat kidney disease or not. Please clarify.
Response to Arguments
Applicant’s arguments with respect to claims 1-9, 11 and 14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Frank Lu, Ph. D., whose telephone number is (571)272-0746. The examiner can normally be reached Monday to Friday, 9 AM to 5 PM.
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/FRANK W LU/
Primary Examiner, Art Unit 1683
January 20, 2025