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 .
Status of the Claims
Claims 1-20 are pending (claim set as filed on 11/24/2025). Claims 1-10 are withdrawn from a restriction/election requirement. Claims 11-20 are currently under examination.
Election/Restrictions
Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected product, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/24/2025.
Priority
Acknowledgement is made of applicant’s claim for priority to the provisional application no. 63/038,305 filed on 6/12/2020. Thus the effective filing date of the invention is 6/12/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/9/2022 and 2/13/2026 considered, initialed, and attached hereto. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
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 15 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 15 recites “to increase a run time to exhaustion” and renders the claim indefinite. It is unclear if increasing the run time to exhaustion means to increase the time the mammal can run before becoming exhausted, or how many times a mammal can complete a run time to exhaustion, or if it means how fast a mammal can run before becoming exhausted. For examination purposes, the phrase has been broadly interpreted to mean to increase the amount of time the animal can run before becoming exhausted.
Claim Rejections - 35 USC § 102
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 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 11-15 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oertzen-Hagemann (Oertzen-Hagemann et al., “Effects of 12 Weeks of Hypertrophy Resistance Exercise Training Combined with Collagen Peptide Supplementation on the Skeletal Muscle Proteome in Recreationally Active Men”, 2019 May 14, Nutrients, 11(1072), pgs. 1-18) and as evidenced by Runners Need (Runners Need, “5 Exercises to Help you Run Faster for Longer”, 2019 Oct 16, https://www.runnersneed.com/expert-advice/training/5-exercises-to-run-faster-for-longer.html, accessed 2026 Jul 23).
Oertzen-Hagemann’s general disclosure relates to an experiment wherein students are administered collagen peptide supplement drinks or placebos daily to study its effects on endurance during physical exercise over a 12 week period (see abstract).
Regarding claim 11, Oertzen-Hagemann teaches the administering of 15 g of collagen peptide supplements to sports students (see Oertzen-Hagemann pg. 3 – “Participants” and “Supplementation”). Students are humans, which are also mammals. Collagen peptides are a kind of hydrolyzed collagen. The endurance of the students administered the supplement increased by more than 5% while deadlifting compared to students administered placebos over a 12 week period (see Oertzen-Hagemann pg. 6, Table 1). As defined by the instant specification, an improvement in “endurance” can be an increase in the level of exertion during the physical activity over the same amount of time (see specification [0025]). Under broadest reasonable interpretation, the increase in exertion the students exhibited in deadlifting over a 12 week period reads on the limitation. The instant specification further defines a sufficient amount of the collagen composition to be about 1-100 mg (see specification [00104]), thus the amount of 15 mg of collagen supplement as stated in the prior art reads on the limitation.
Regarding claim 12, Oertzen-Hagemann teaches that both the students administered the supplement and the students that were administered the placebo had undergone exercise routines such as squatting before the supplement study began (see pg. 3 – “Participants”) and were currently undergoing exercise training routines during the supplement study (see pg. 3 – “Supplementation”).
Regarding claim 13, Oertzen-Hagemann teaches that both the students administered the supplement and the student administered the placebo were subject to a exercise training routine (see pg. 3 – “Supplementation”) and the increase in endurance as indicated by increase in deadlifting weight was measured after the exercise training period (see pg. 6, Table 1).
Regarding claim 14, Oertzen-Hagemann teaches the time of the supplement study which included an exercise training routine was 12 weeks (see pg. 3 – “Supplementation”), and the endurance of the students was measured at the end of the 12 week period (see pg. 6, Table 1).
Regarding claim 15, Oertzen-Hagemann teaches the administering of 15 g of collagen peptide supplements to sports students (see Oertzen-Hagemann pg. 3 – “Participants” and “Supplementation”) and that the collagen peptide supplementation resulted in an increase in muscle strength (see Oertzen-Hagemann abstract) by over 5% compared to students administered a placebo (see Oertzen-Hagemann pg. 6, Table 1). The students increasing their muscle strength would also naturally increase their run time to exhaustion as evidenced by Runners Need (see Runners Need pg. 2, ¶ 3). As noted in the 112b rejections above, the phrase “to increase a run time to exhaustion” is indefinite and has been broadly interpreted to mean to increase the amount of time the animal can run before becoming exhausted and the phrase “in an amount sufficient to” renders the claim indefinite and thus the phrase has been broadly interpreted to mean any amount of collagen supplement that can result in the desired effect (e.g. increase a run time to exhaustion) reads on the claimed limitation. Regarding claim 18, Oertzen-Hagemann teaches the collagen peptide supplement was administered to the students daily (see pg. 3 – “Supplementation”).
Regarding claim 19, Oertzen-Hagemann teaches the collagen peptide supplement was administered to the students on training days where they were completing physical exercise (see pg. 3 – “Supplementation”).
Regarding claim 20, Oertzen-Hagemann teaches the collagen peptide supplement was dissolved in water and administered to the students as a drink (see pg. 3 – “Supplementation”).
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.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Oertzen-Hagemann (Oertzen-Hagemann et al., “Effects of 12 Weeks of Hypertrophy Resistance Exercise Training Combined with Collagen Peptide Supplementation on the Skeletal Muscle Proteome in Recreationally Active Men”, 2019 May 14, Nutrients, 11(1072), pgs. 1-18) and further in view of Woo (Woo et al., “Anti-Obesity Effects of Collagen Peptide Derived from Skate (Raja kenojei) Skin Through Regulation of Lipid Metabolism”, 2018 Aug 30, Marine Drugs, 16(306), pgs. 1-12), and as evidenced by Runners Need (Runners Need, “5 Exercises to Help you Run Faster for Longer”, 2019 Oct 16, https://www.runnersneed.com/expert-advice/training/5-exercises-to-run-faster-for-longer.html, accessed 2026 Jul 23).
Oertzen-Hagemann’s general disclosure has been set forth above.
Regarding claim 16, Oertzen-Hagemann teaches the administering of 15 g of collagen peptide supplements to sports students (see Oertzen-Hagemann pg. 3 – “Participants” and “Supplementation”). It is also taught that the endurance of the students administered the supplement increased by more than 5% while deadlifting compared to students administered placebos over a 12 week period (see Oertzen-Hagemann pg. 6, Table 1).
However, Oertzen-Hagemann does not teach the supplement decreases sterol regulatory element binding protein-1c (SREBP-1c) in a mammal by about 5% or more compared to mammals not administered the supplement.
Woo’s general disclosure relates to the administering of collagen peptides to mice which downregulates sterol regulatory element binding protein-1c, having an anti-obesity effect to lower body fat (see abstract).
Regarding claim 16, Woo teaches a decrease in expression of sterol regulatory element binding protein-1c by up to 18% in mice administered a collagen peptide supplement compared to mice who were in a control group (see pg. 5, ¶ 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date to arrive at the claimed invention by decreasing the level of sterol regulatory element binding protein-1c as taught in Woo with the collagen peptide administering method as taught in Oertzen-Hagemann. One would have been motivated because Woo teaches the collagen peptides were administered to the mice at a concentration of 200 mg/kg (or 0.2 g/kg) of body weight (see Woo abstract) while Oertzen-Hagemann teaches the administering of 15 g of collagen peptides to athletes with an average body weight of 77.9 kg (see Oertzen-Hagemann pg. 3 – “Participants), equaling a concentration of 0.19 g/kg. Thus the ordinary artisan would have had a reasonable expectation of success that since Woo and Oertzen-Hagemann contain similar concentrations of collagen peptide in their supplements, the method of Oertzen-Hagemann would also have the effect of decreasing malondialdehyde levels as Woo’s disclosure does.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Oertzen-Hagemann (Oertzen-Hagemann et al., “Effects of 12 Weeks of Hypertrophy Resistance Exercise Training Combined with Collagen Peptide Supplementation on the Skeletal Muscle Proteome in Recreationally Active Men”, 2019 May 14, Nutrients, 11(1072), pgs. 1-18), further in view of Han (Han et al., “Hepatoprotective Effect of Collagen Peptides From Cod Skin Against Liver Oxidative Damage In Vitro and In Vivo”, 2014 Oct 26, Cell Biochemistry Biophysics, 71, pgs. 1089-1095), and as evidenced by Runners Need (Runners Need, “5 Exercises to Help you Run Faster for Longer”, 2019 Oct 16, https://www.runnersneed.com/expert-advice/training/5-exercises-to-run-faster-for-longer.html, accessed 2026 Jul 23).
Oertzen-Hagemann’s general disclosure has been set forth above.
Regarding claim 17, Oertzen-Hagemann teaches the administering of 15 g of collagen peptide supplements to sports students (see Oertzen-Hagemann pg. 3 – “Participants” and “Supplementation”). It is also taught that the endurance of the students administered the supplement increased by more than 5% while deadlifting compared to students administered placebos over a 12 week period (see Oertzen-Hagemann pg. 6, Table 1). As noted in the 112b rejection above, the phrase “in an amount sufficient to” renders the claim indefinite and thus the phrase has been broadly interpreted to mean any amount of collagen supplement that can result in the desired effect (e.g. in decrease malondialdehyde levels in a mammal) reads on the claimed limitation.
However, Oertzen-Hagemann does not teach the supplement decreases malondialdehyde levels in a mammal by about 5% or more compared to mammals not administered the supplement.
Han’s general disclosure relates to administering cod-skin collagen peptides to mice, which has an effect of lowering malondialdehyde levels (see pg. 1091, ¶10 and Figure 4).
Regarding claim 17, Han teaches the administering of cod-skin derived collagen peptides to liver damaged mice which decreased their malondialdehyde levels to about 2-2.5 nmol/ml compared to the model mice who were not administered the collagen peptides and had a malondialdehyde level of about 3 nmol/ml (se see pg. 1091, ¶10 and Figure 4). This would be over a 5% decrease which reads on the claimed range.
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It would have been obvious to one of ordinary skill in the art before the effective filing date to arrive at the claimed invention by decreasing the level of malondialdehyde as taught in Han with the collagen peptide administering method as taught in Oertzen-Hagemann. One would have been motivated because Han teaches that the collagen peptides were administered to the mice at a concentration of 2 g/kg of body weight (see Han pg. 1090, ¶ 9) while Oertzen-Hagemann teaches the administering of 15 g of collagen peptides to athletes with an average body weight of 77.9 kg (see Oertzen-Hagemann pg. 3 – “Participants”), equaling a concentration of 0.19 g/kg. Thus the ordinary artisan would have had a reasonable expectation of success that since Han and Oertzen-Hagemann contain similar concentrations of collagen peptide in their supplements, the method of Oertzen-Hagemann would also have the effect of decreasing malondialdehyde levels as Han’s disclosure does.
Conclusion
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emmalee R. Williams whose telephone number is (571)272-5472. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.R.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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