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.
Claim Objections
Claims 1 and 3 are objected to because of the following informalities:
Lines 10-12 of claim 1 should recite “the second serum or plasma sample has decreased from the amount of the biomarker in the first serum or plasma sample”; and
it appears the limitation “wherein the weight loss comprises a complete and balanced pet food” should recite “wherein the weight loss diet comprises a complete and balanced pet food” in lines 1-2 of claim 3.
Appropriate correction is required.
Prior Art
D1: United States Patent US 5,628,328 to Nissen et al. (herein Nissen) as cited on the 29 February 2024 IDS.
D2: International Publication WO 2021/156181 to Martin et al. (herein Martin) as cited on the 29 February 2024 IDS.
D3: International Publication WO 01/74345 to Ingram as cited on the 29 February 2024 IDS.
D4: French Publication FR 2927771 to Dabadie (see machine translation provided).
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claims 1-7:
Step 1: Claims 1-7 are directed toward a process and thus fall within one of the four statutory categories of invention (see MPEP 2106.03 I. The Four Categories).
Step 2A Prong 1: Independent, instant claim 1 recites the limitation “determining the weight loss diet is efficacious if the amount of the biomarker in the second serum or plasma sample has decreased from the amount in the first serum sample or determining the weight loss diet is inefficacious if the amount of the biomarker in the second serum or plasma sample has not changed or increased from the amount of the biomarker in the first serum or plasma sample” which under its broadest reasonable can be performed in the mind, falling under the mental processes grouping of abstract ideas, and thus the claims recites a judicial exception (see MPEP 2106.04(a) III. Mental Processes).
Step 2A Prong 2: The judicial exception of claim 1 is not integrated into a practical application because after the determining step, nothing else is done. The additional steps of determining the amount of biomarker in a first or second sample are themselves abstract ideas. Furthermore, the additional steps of analyzing amount to mere data gathering which is an insignificant extra-solution activity (see MPEP 2106.05(g) Insignificant Extra-Solution Activity) and the courts have held that adding an insignificant extra-solution activity to the judicial exception fails to integrate said judicial exception into a practical application (see MPEP 2106.04(d) Integration of a Judicial Exception Into A Practical Application). Dependent claims 2-6 merely further limit the insignificant extra-solution activity of data gathering. Claim 7 recites “advising a different weight loss diet for the canine”, however, this does not integrate the judicial exception into a practical application because while there is a treating step following the determination step, the treatment is not sufficiently particular (see MPEP 2106.04(d)(2) Particular Treatment and Prophylaxis in Step 2A Prong Two). The treatment of advising a different weight loss diet is extremely generalized and not particular to the specific biomarkers for determining efficacy.
Step 2B: The method of claim 1 is considered well-understood routine and conventional (WURC) in the art as evidence by primary reference US 5,628,328 to Nissen et al. and, per MPEP 2106.05 Eligibility Step 2B: Whether a Claim Amounts to Significantly More, using the judicial exception with what is WURC cannot qualify as significantly more. Dependent claims 2-7 fail to provide additional steps/structure that would amount to significantly more than the judicial exception.
Claims 8-15:
Step 1: Claims 8-15 are directed toward a process and thus fall within one of the four statutory categories of invention (see MPEP 2106.03 I. The Four Categories).
Step 2A Prong 1: Independent, instant claim 8 recites the limitation “determining the weight loss diet is efficacious if the amount of the biomarker in the second serum or plasma sample has decreased from the amount in the first serum sample or determining the weight loss diet is inefficacious if the amount of the biomarker in the second serum or plasma sample has not changed or increased from the amount of the biomarker in the first serum or plasma sample” which under its broadest reasonable can be performed in the mind, falling under the mental processes grouping of abstract ideas, and thus the claims recites a judicial exception (see MPEP 2106.04(a) III. Mental Processes).
Step 2A Prong 2: The judicial exception of claim 8 is not integrated into a practical application because after determining if the weight loss diet is efficacious, nothing else is done. Note that determining the weight loss diet is inefficacious, and thus the recited composition and dependent claims 9-13, are an alternate clause. The additional steps of determining the amount of biomarker in a first or second sample are themselves abstract ideas. Furthermore, the additional steps of analyzing amount to mere data gathering which is an insignificant extra-solution activity (see MPEP 2106.05(g) Insignificant Extra-Solution Activity) and the courts have held that adding an insignificant extra-solution activity to the judicial exception fails to integrate said judicial exception into a practical application (see MPEP 2106.04(d) Integration of a Judicial Exception Into A Practical Application). Dependent claims 14-15 merely further limit the insignificant extra-solution activity of data gathering.
Step 2B: The method of claim 8 is considered well-understood routine and conventional (WURC) in the art as evidence by primary reference US 5,628,328 to Nissen et al. and, per MPEP 2106.05 Eligibility Step 2B: Whether a Claim Amounts to Significantly More, using the judicial exception with what is WURC cannot qualify as significantly more. Dependent claims 9-15 fail to provide additional steps/structure that would amount to significantly more than the judicial exception.
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.
Claims 1-2, 4-7, 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).
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 in efficacious. Furthermore, Nissen discloses administering a weight loss diet at least one week prior (see Col. 9, lines 54-56). Thus Nissen anticipates all the limitations of the method of claim 1.
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 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 claim 7, Nissen discloses the method of claim 1. As determining whether the weight loss diet is inefficacious in claim 1 is an alternate clause, thus the limitations of claim 7 are not further limiting.
However, note that secondary references Ingram and Martin disclose a composition for controlling weight gain and/or inducing weight loss of an individual (see abstract of Ingram and abstract/pg. 3, 3rd paragraph of Martin), wherein the individual is a dog (see pg. 6, lines 4-5 of Ingram and pg. 12, 3rd paragraph of Martin).
Nissen, Ingram, and Martin are all analogous in the field of monitoring weight loss in canines. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to advise the diets of Ingram or Martin in a canine with inefficacious weight loss for the benefit of inducing weight loss/decreasing weight gain in an individual (see abstract of Ingram and abstract/pg. 3, 3rd paragraph of Martin).
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 in efficacious. Furthermore, Nissen discloses administering a weight loss diet at least one week prior (see Col. 9, lines 54-56). Thus Nissen anticipates all the limitations of the method of claim 1.
As determining whether the weight loss diet is inefficacious is an alternate clause, the limitation “wherein, when the weight loss diet is inefficacious, providing an efficacious weight loss diet to the canine that comprises protein, fat, carbohydrates, omega-3 fatty acids, and isoflavones; wherein the protein to carbohydrate is in a ratio ranging from 4.5:1 to 2.5:1 by weight as fed” is not further limiting nor are any of the claims further limiting the wherein clause, such as claims 9-13.
However, note that secondary reference 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 Ingram 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 Ingram 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. 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 Ingram 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). 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 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 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. 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.
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, Nissen discloses the method of claim 8, 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.
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 3 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent US 5,628,328 to Nissen et al. (herein Nissen).
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 15, Nissen discloses the method of claim 8, 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.
Conclusion
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/KATHRYN ELIZABETH LIMBAUGH/Primary Examiner, Art Unit 1797