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 .
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.
Response to Amendment
In view of Applicant’s Amendments filed 30 April 2026, previous objection of claims 1 and 3 has been withdrawn.
Response to Arguments
Applicant’s arguments, see pgs. 6-7, filed 30 April 2026, with respect to the rejection of claims 1 an 8 under 35 U.S.C. 101 have been fully considered and are persuasive. Newly amended independent claims 1 and 8 apply a judicial exception to affect a particular treatment, in this instance gathering data to determine inefficacy of a current diet plan to administer a specific diet formulation in canines and thus integrates the judicial exception into a practical application (see 2106.04(d)(2) Particular Treatment and Prophylaxis in Step 2A Prong Two). The rejection has been withdrawn.
Applicant’s arguments, see pgs. 7-8, filed 30 April 2026, with respect to the rejection of claims 1-2, 4-6, and 8-14 under 102(a)(1) have been fully considered and are persuasive. Claim 7 has been canceled. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection under 35 U.S.C. 103 is made in view of International Publication WO 2021/156181 to Martin et al. (herein Martin) as cited on the 29 February 2024 IDS; International Publication WO 01/74345 to Ingram as cited on the 29 February 2024 IDS; and French Publication FR 2927771 to Dabadie (see machine translation provided).
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 1-6 and 8-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Patent US 5,628,328 to Nissen et al. (herein Nissen) in view of International Publication WO 2021/156181 to Martin et al. (herein Martin) as cited on the 29 February 2024 IDS; International Publication WO 01/74345 to Ingram as cited on the 29 February 2024 IDS; and French Publication FR 2927771 to Dabadie (see machine translation provided).
Regarding claim 1, Nissen discloses a method for determining muscle mass in a human subject useful for monitoring weight loss by measuring the amount of a metabolic marker for 3-methylhistidine in blood samples collected periodically thereafter (see abstract).
The method comprising:
Obtaining the total body weight of the subject;
Administering to said subject a known amount of a metabolic marker for 3-methylhistidine;
Periodically removing blood or urine samples from said subject and recording time to the nearest second;
Measuring the amount of said marker and of 3-methylhistidine in each sample;
generating a three-compartment mathematical model from said measurements comprising values for the functional transfer rates in and out of said compartments, values for the mass of 3-methylhistidine in each compartment and values for the mass transfer rates of 3-methylhistidine in and out of said compartments;
calculating muscle mass as a function of the numerical value of at least one of said values and the total body weight of the subject (see Col. 7, lines 1-33)
Nissen discloses the method can be performed on dogs (i.e., canines) as well as humans (see Table 4) and Nissen discloses that the biomarker is expected to decrease between a first sample and subsequent samples (i.e., efficacious) (see Fig. 2) which stands to reason not following this curve (i.e., stays the same or increases) would be considered inefficacious. Furthermore, Nissen discloses administering a weight loss diet at least one week prior (see Col. 9, lines 54-56).
Nissen fails to disclose “based on determining that the weight loss diet is inefficacious, advising a different weight loss diet for the canine, wherein the different weight loss diet for the canine comprises protein, fat, carbohydrate, omega-3 fatty acids, and isoflavones and has a ratio of the protein to the carbohydrate from 4.5:1 to 2.5:1 by weight fed” as recited in the instant claim.
Martin disclose a composition for controlling weight gain and/or inducing weight loss of an individual (see abstract and pg. 3, 3rd paragraph), wherein the individual is a dog (see pg. 12, 3rd paragraph). Martin discloses the composition comprises protein, fat, and carbohydrates (see pg. 23, lines 23-25). Martin discloses wherein the percentage of carbohydrate is up to 46.4% and protein is up to 32.5% (see pg. 20, lines 9-15). As “up to” reads on the particular percentage or less, the conceivable ratios of protein to carbohydrates of Martin overlap the claimed ratios of 4.5:1 to 2.5:1 by weight as fed. Per MPEP 2144.04 I. Overlapping, Approaching, and Similar Ranges, Amounts, and Proportions, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date for the composition of Martin for the protein to carbohydrate ratios to be 4.5:1 to 2.5:1 by weight as fed for benefit of adjusting protein and carbohydrate intake as desired in view of other medical conditions present.
Nissen and Martin are all analogous in the field of monitoring weight loss in canines. Both Nissen and Martin deal with maintaining muscle mass in the presence of weight loss (see pg. 4, 1st and last paragraph of Martin). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to advise the diet composition of Nissen in a canine with inefficacious weight loss for the benefit of inducing weight loss/decreasing weight gain in an individual (see abstract/pg. 3, 3rd paragraph of Martin).
Ingram discloses a composition for controlling weight gain and/or inducing weight loss of an individual, wherein the individual is a dog (see abstract; pg. 6, lines 4-5). Ingram discloses administering isoflavones, genistein, daidzein, formononetin, and biochanin A in combination with food (see pg. 4, 2nd paragraph and pg. 5, 2nd paragraph).
Nissen, Ingram, and Martin are all analogous in the field of monitoring weight loss in canines. Furthermore, Ingram is directed toward anti-obesity treatment that doesn’t put stress on muscles (see pg. 2, 2nd paragraph). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to add the isoflavones of Ingram to the composition of Nissen in view of Martin for the benefit of inducing weight loss/decreasing weight gain individual (see abstract of Ingram).
Dabadie discloses a dietary composition comprising fats such as EPA , DHA, and alpha linolenic acid (i.e., omega-3 fatty acids) that are present in 3.5 to 12.5 % (see paragraphs 10-12 of machine translation).
Dabadie, Nissen, Ingram, and Martin are all analogous in the field of monitoring weight loss. Ingram doesn’t explicitly disclose weight loss related to muscle as the other references do, however, is still related in the field of monitoring weight loss and absent reason not to try would be obvious. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the composition of Nissen in view of Martin and Ingram with the omega-3 fatty acids of Dabadie for the benefit of adding unsaturated fats that have been shown to reduce risk of metabolic syndrome (see paragraph 7 of machine translation of Dabadie).
Regarding claim 2, Nissen discloses the method of claim 1, and discloses wherein the weight loss diet has been administered for at least one week (see Col. 9, lines 54-56). As the broadest reasonable interpretation of Nissen is anything one week or greater, Nissen reads on the broadest reasonable interpretation of “on a regular basis” as recited in the instant claim.
Regarding claim 3, Nissen discloses the method of claim 1, and discloses wherein the weight loss diet has been administered for at least one week (see Col. 9, lines 54-56). As the broadest reasonable interpretation of Nissen is anything one week or greater, Nissen overlaps with “at least 1 month” or in others one month or greater as recited in the instant claim. Per MPEP 2144.04 I. Overlapping, Approaching, and Similar Ranges, Amounts, and Proportions, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to administer the weight loss diet for at least one month for the benefit of tracking a longer weight loss period.
Regarding claim 4, Nissen discloses the method of claim 1, As Nissen discloses administering a weight-management diet to subjects and the subject can be a dog (i.e., pet), any food given to said pet under a weight-management diet would broadly read on “a complete balanced pet food” as recited in the instant claim (see Col. 9, lines 54-56).
Regarding claim 5, Nissen discloses the method of claim 1,and Nissen discloses administering a weight-management diet to subjects (i.e., canine) (see Col. 9, lines 54-56).
Regarding claim 6, Nissen discloses the method of claim 1, and Nissen discloses monitoring lean body mass (see Table 1; Col. 12, lines 8-18); wherein the biomarker could indicate certain metabolic situations such as diabetes (see Col. 5, lines 32-34); and monitoring weight loss programs (i.e., treating overweight or obese subjects).
Regarding claims 8-13 Nissen discloses a method for determining muscle mass in a human subject useful for monitoring weight loss by measuring the amount of a metabolic marker for 3-methylhistidine in blood samples collected periodically thereafter (see abstract).
The method comprising:
Obtaining the total body weight of the subject;
Administering to said subject a known amount of a metabolic marker for 3-methylhistidine;
Periodically removing blood or urine samples from said subject and recording time to the nearest second;
Measuring the amount of said marker and of 3-methylhistidine in each sample;
generating a three-compartment mathematical model from said measurements comprising values for the functional transfer rates in and out of said compartments, values for the mass of 3-methylhistidine in each compartment and values for the mass transfer rates of 3-methylhistidine in and out of said compartments;
calculating muscle mass as a function of the numerical value of at least one of said values and the total body weight of the subject (see Col. 7, lines 1-33)
Nissen discloses the method can be performed on dogs (i.e., canines) as well as humans (see Table 4) and Nissen discloses that the biomarker is expected to decrease between a first sample and subsequent samples (i.e., efficacious) (see Fig. 2) which stands to reason not following this curve (i.e., stays the same or increases) would be considered inefficacious. Furthermore, Nissen discloses administering a weight loss diet at least one week prior (see Col. 9, lines 54-56).
Nissen fails to disclose “based on determining that the weight loss diet is inefficacious, advising a different weight loss diet for the canine, wherein the different weight loss diet for the canine comprises protein, fat, carbohydrate, omega-3 fatty acids, and isoflavones, wherein the protein to the carbohydrate is in a ratio ranging from 4.5:1 to 2.5:1 by weight fed” as recited in the instant claim.
Martin disclose a composition for controlling weight gain and/or inducing weight loss of an individual (see abstract and pg. 3, 3rd paragraph), wherein the individual is a dog (see pg. 12, 3rd paragraph). Martin discloses the composition comprises protein, fat, and carbohydrates (see pg. 23, lines 23-25). Martin discloses wherein the percentage of carbohydrate is up to 46.4% and protein is up to 32.5% (see pg. 20, lines 9-15). As “up to” reads on the particular percentage or less, the conceivable ratios of protein to carbohydrates of Martin overlap the claimed ratios of 4.5:1 to 2.5:1 by weight as fed and 4.25:1 to 3.75:1 by weight as fed (see claim 13). The cited amount of protein in Martin falls within the claimed range of claim 12. The cited amount of carbohydrate covers the range as recited in claim 12. Per MPEP 2144.04 I. Overlapping, Approaching, and Similar Ranges, Amounts, and Proportions, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date for the composition of Martin for the protein to carbohydrate ratios to be 4.5:1 to 2.5:1 or 4.25:1 to 3.75:1 by weight as fed for benefit of adjusting protein and carbohydrate intake as desired in view of other medical conditions present.
Nissen and Martin are all analogous in the field of monitoring weight loss in canines. Both Nissen and Martin deal with maintaining muscle mass in the presence of weight loss (see pg. 4, 1st and last paragraph of Martin). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to advise the diet composition of Nissen in a canine with inefficacious weight loss for the benefit of inducing weight loss/decreasing weight gain in an individual (see abstract/pg. 3, 3rd paragraph of Martin).
Ingram discloses a composition for controlling weight gain and/or inducing weight loss of an individual, wherein the individual is a dog (see abstract; pg. 6, lines 4-5). Ingram discloses administering isoflavones, genistein, daidzein, formononetin, and biochanin A in combination with food (see pg. 4, 2nd paragraph and pg. 5, 2nd paragraph) (see claim 10). Ingram discloses the amount of isoflavones, regardless of the amount of food, is 5-500 mg/day (see pg. 5, last paragraph) which falls within the claimed range 300 mg to 1,500 mg per kilogram of the pet food composition as recited in instant claim 11. Per MPEP 2144.04 I. Overlapping, Approaching, and Similar Ranges, Amounts, and Proportions, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date for the amount of isoflavones to be 300 to 1,500 mg per kg of pet food for the benefit of controlling the isoflavone to pet food ratio.
Nissen, Ingram, and Martin are all analogous in the field of monitoring weight loss in canines. Furthermore, Ingram is directed toward anti-obesity treatment that doesn’t put stress on muscles (see pg. 2, 2nd paragraph). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to add the isoflavones of Ingram to the composition of Nissen in view of Martin for the benefit of inducing weight loss/decreasing weight gain individual (see abstract of Ingram).
Dabadie discloses a dietary composition comprising fats such as EPA , DHA, and alpha linolenic acid (i.e., omega-3 fatty acids) that are present in 3.5 to 12.5 % (see paragraphs 10-12 of machine translation), which overlaps with the claimed range of 0.1 to about 5%. Per MPEP 2144.04 I. Overlapping, Approaching, and Similar Ranges, Amounts, and Proportions, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date for the composition of Dabadie to have said omega-3 fatty acids present in the composition in the range of 0.1 to about 5% for the benefit of being able to control the fat content as desired (see claim 9).
Dabadie, Nissen, Ingram, and Martin are all analogous in the field of monitoring weight loss. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the composition of Nissen in view of Martin and Ingram with the omega-3 fatty acids of Dabadie for the benefit of adding unsaturated fats that have been shown to reduce risk of metabolic syndrome (see paragraph 7 of machine translation of Dabadie).
Regarding claim 14, the combination of references above render obvious the method of claim 8, and discloses wherein a weight loss diet has been administered for at least one week (see Col. 9, lines 54-56). As the broadest reasonable interpretation of Nissen is anything one week or greater, Nissen reads on the broadest reasonable interpretation of “on a regular basis” as recited in the instant claim. While Nissen doesn’t explicitly disclose “after determining the weight loss diet in inefficacious”, however, Nissen discloses this is the appropriate amount of time to a weight loss diet prior to reassessing efficacy.
Regarding claim 15, the combination of references above render obvious the method of claim 8, and discloses wherein a weight loss diet has been administered for at least one week (see Col. 9, lines 54-56). As the broadest reasonable interpretation of Nissen is anything one week or greater, Nissen overlaps with “at least 1 month” or in others one month or greater as recited in the instant claim. Per MPEP 2144.04 I. Overlapping, Approaching, and Similar Ranges, Amounts, and Proportions, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to administer the weight loss diet for at least one month for the benefit of tracking a longer weight loss period. While Nissen doesn’t explicitly disclose “after determining the weight loss diet in inefficacious”, however, Nissen discloses this is the appropriate amount of time to a weight loss diet prior to reassessing efficacy.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E LIMBAUGH whose telephone number is (571)272-0787. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHRYN ELIZABETH LIMBAUGH/Primary Examiner, Art Unit 1797
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