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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 3, 2025, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan (2022-107740) on July 4, 2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 12 – 21 are examined here-in.
Claim Objections
Claims 12 and 20 are objected to because of the following informalities:
Claim 12 recites “comprising feeding a subject with an effective amount”. This phrase should be simplified to “comprising feeding a subject an effective amount”.
Claim 20 recites “wherein enhancement of the endurance”, which should be simplified to “wherein enhancement of endurance”.
Appropriate correction is required.
Claim Interpretation
The instant claims include the terms “highly unsaturated fatty acid” and “medium-chain fatty acid”. These terms appear to be defined in paragraphs 0028 and 0029 of the instant specification, which states “the highly unsaturated fatty acid is a fatty acid with 18 or more carbon atoms and 3 or more double bonds” and “the medium-chain fatty acid refers to that with 8 to 12 carbon atoms”. The terms “highly unsaturated fatty acid” and “medium-chain fatty acid” will thus be interpreted as defined above.
Instant claim 20 refers to “high-intensity exercise”, which appears to be defined in the instant specification as per the “Global Physical Activity Questionnaire” (paragraph 0034). The relative terms “prolonged”, “accelerated”, “increased”, “reduced” and “enhanced” are interpreted to be relative to a group which does not follow the method of the claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
As discussed above, a “medium-chain fatty acid” is defined in the instant specification as having 8 to 12 carbon atoms (paragraph 0029). Therefore, the limitation “wherein the medium-chain fatty acid is a C8 – C12 fatty acid” does not further limit the definition of medium-chain fatty acid as used in the previous claims. Therefore, claim 19 fails to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims complies with the statutory requirements.
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 12, 13, and 17 – 21 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Nakajima (US 6,313,167 B1).
Nakajima teaches a composition containing an n-3 highly unsaturated fatty acid, preferably in the form of a natural triglyceride, which improves maximum oxygen intake and increases anaerobic threshold values, thus enhancing exercise capacity (abstract). Nakajima teaches the composition includes an n-3 highly unsaturated fatty acid in the form of a natural triglyceride (column 3 lines 36 – 38). Nakajima teaches the n-3 highly unsaturated fatty acid accounts for more than 60% of the constituent fatty acids, with medium-chain fatty acids being the remaining amount (column 4 line 65 to column 5 line 5). These teachings anticipate instant claim 12, which recites a method of enhancing endurance by feeding a subject a composition including a triglyceride that contains a highly unsaturated fatty acid and a medium-chain fatty acid. Nakijima’s teaching that the composition improves maximum oxygen intake and increases anaerobic threshold values, thus enhancing exercise capacity (abstract) reads on “enhancing endurance” as recited in the instant claim because the instant specification states “if the anaerobic exercise threshold is significantly higher in the group of ingesting a test substance than in the group before or without ingestion of the test substance, the test substances is also considered to exert an endurance-enhancing effect” (paragraph 0022).
Nakajima’s teaching that the n-3 highly unsaturated fatty acid accounts for more than 60% of the constituent fatty acids, with medium-chain fatty acids being the remaining amount (column 4 line 65 to column 5 line 5) anticipates instant claim 13. In this case “more than 60%” falls within the range of 10 to 70 wt% and “the remaining amount” would be 40%, falling within the range of 20 to 70 wt% as recited in claim 13. Specific examples in the prior art that fall within the claimed range or prior art teachings that overlap the claimed range with sufficient specificity are anticipatory according to MPEP 2131.03(ii).
Nakajima’s teaching that the n-3 highly unsaturated fatty acid is eicosapentaenoic acid or docosahexaenoic acid (column 3 lines 33 – 35) anticipates instant claims 17 and 18.
Nakajima’s teaching that medium-chain fatty acids are constituent fatty acids in the triglyceride (column 4 line 65 to column 5 line 5) anticipates instant claim 19. As noted above, “medium-chain fatty acids” are defined as having carbon chains of 8 – 12 (instant specification paragraph 0029), therefore, Nakajima’s teaching for medium-chain fatty acids reads on the limitation “wherein the medium-chain fatty acid is a C8 – C12 fatty acid”.
Nakijima’s teaching that the composition improves maximum oxygen intake and increases anaerobic threshold values, thus enhancing exercise capacity (abstract) anticipates instant claim 20.
Nakajima teaches the composition is in the form of a food (column 2 lines 41 – 47), anticipating instant claim 21.
However, in the event that the previous does not have sufficient specificity to rise to anticipation, claims 12, 13, and 17 – 21 are also rejected under 35 U.S.C. 103 below.
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 non-obviousness.
Claims 12 – 21 are rejected under 35 U.S.C. 103 as being unpatentable over Nakajima (as cited above).
For the purposes of this ground of rejection only, and purely arguendo, the examiner will take the position that Nakajima does not teach a specific embodiment (i.e., preferred embodiment, working example, etc.) having all of the claimed elements arranged as required by claims 12, 13, and 17 – 21 without resorting to some “picking and choosing” within the prior art disclosure. That being said, although Nakajima thus would not be anticipatory by this interpretation of the facts, it nevertheless does fairly suggest the claimed invention, as shown below.
Nakajima teaches a composition containing an n-3 highly unsaturated fatty acid, preferably in the form of a natural triglyceride, which improves maximum oxygen intake and increases anaerobic threshold values, thus enhancing exercise capacity (abstract).
Nakajima teaches the composition includes an n-3 highly unsaturated fatty acid in the form of a natural triglyceride (column 3 lines 36 – 38). Nakajima teaches the n-3 highly unsaturated fatty acid accounts for more than 60% of the constituent fatty acids, with medium-chain fatty acids being the remaining amount (column 4 line 65 to column 5 line 5).
Nakajima teaches the composition is in the form of a food which improves exercise capacity and stamina (column 2 lines 41 – 47).
Nakajima teaches the n-3 highly unsaturated fatty acid is eicosapentaenoic acid or docosahexaenoic acid (column 3 lines 33 – 35).
Nakajima teaches the composition is administered over 10 weeks (Figures 3 – 6, column 7 lines 14 – 25).
As discussed above, for the purposes of this ground of rejection only, and purely arguendo, the examiner will take the position that Nakajima does not teach a specific embodiment having each of the claimed elements, however, claims 12 – 21 are rendered prima facie obvious over the teachings of Nakajima, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results (MPEP 2143(i)(a)). In the instant case, all the claimed elements (e.g., highly unsaturated fatty acids, medium-chain fatty acids, triglycerides) were known in the prior art (e.g., food compositions) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (e.g., a method for administering a composition which includes a triglyceride having a highly unsaturated fatty acid and a medium-chain fatty acid) to one of ordinary skill in the art.
Nakajima’s teaching for a food composition containing an n-3 highly unsaturated fatty acid, preferably in the form of a natural triglyceride also containing a medium-chain fatty acid, which improves maximum oxygen intake and increases anaerobic threshold values, thus enhancing exercise capacity (abstract, column 2 lines 41 – 47, column 4 line 65 to column 5 line 5) reads on instant claim 12. Nakajima’s claims and examples highlight the administration of the above composition, and Nakijima’s teaching that the composition improves maximum oxygen intake and increases anaerobic threshold values, thus enhancing exercise capacity (abstract) reads on “enhancing endurance” as recited in the instant claim because the instant specification states “if the anaerobic exercise threshold is significantly higher in the group of ingesting a test substance than in the group before or without ingestion of the test substance, the test substances is also considered to exert an endurance-enhancing effect” (paragraph 0022).
Nakajima’s teaching that the n-3 highly unsaturated fatty acid accounts for more than 60% of the constituent fatty acids, with medium-chain fatty acids being the remaining amount (column 4 line 65 to column 5 line 5) reads on instant claim 13. In this case “more than 60%” overlaps on the range of 10 to 70 wt% and “the remaining amount” would be 40%, falling within the range of 20 to 70 wt% as recited in claim 13. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
In Example 2, Nakajima teaches 18 capsules have a total of 1.6 g /day of eicosapentaenoic acid for a period of 10 weeks (column 13 lines 5 – 8, 13 – 17). The average body weight reported in Table 1 is 58.2 kg (Table 1, columns 3 – 4). By the Examiner’s calculations, the administration of 1.6 g to a 58.2 kg person is equal to 27.5 mg/kg body weight/day. Administration of 27.5 mg highly unsaturated fatty acid per kg of body weight per day overlaps on the instantly claimed range of 19 to 30 mg/kg body weight/day, as recited in claim 14. Nakajima’s teaching that the administration period is 10 weeks (column 13 lines 13 – 17), overlaps on the claimed range of 8 weeks or longer recited in claim 14. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
In Example 2, Nakajima’s control group does not receive fish oil capsules (column 13 lines 4 – 12). Although Nakajima does not explicitly discuss the normal diet of the study’s subjects, it is within the expertise of a person of skill in the art to design the experimental group and control group so as to avoid confounding variables such as the consumption of fishery products. In other words, since the study is targeted to understanding the role of fish oil on patient health, a person of skill in the art would necessarily recognize that consumption of fish products outside of those given in the experiment may confound results, therefore a person of skill in the art would limit the consumption of fish products for the subjects of the study. Optimization through routine experimentation, in this case, optimizing the limited consumption of fishery products to an amount less than 1.1 kcal/kg body weight/day as recited in claim 15, is prima facie obvious according to MPEP 2144.05(ii).
In Table 1, Nakajima reports the average maximum oxygen intake for athletes is 70.7 ml/kg/min, with a minimum value of 61.3 ml/kg/min and a maximum value of 75.9 ml/kg/min (Table 1, column 4 lines 3 – 5). A person of ordinary skill in the art has the necessary expertise to recognize that the maximum oxygen intake for non-athlete persons would be less than that of athletes. As such, a person of skill in the art would expect the average maximum oxygen intake for non-athlete persons to be less than 70.7 ml/kg/min. Since Table 1 shows a value of 61.3 ml/kg/min, a person of ordinary skill in the art would expect a non-athlete person to have a maximum oxygen intake which is less. A maximum oxygen intake less than 61.3 ml/kg/min overlaps on the claimed range of less than 60 ml/kg/min as recited in claim 16. Further, since the method is targeted to “enhancing endurance” a person of ordinary skill in the art would recognize that endurance enhancement would be most necessary for persons who have low endurance, such as those with a maximum oxygen intake less than the athletes reported in Table 1. For these reasons, a person of ordinary skill in the art would be motivated to choose subjects for the method of enhancing endurance which have a maximum oxygen intake less than 60 ml/kg/min as recited in claim 16.
Nakajima’s teaching that the n-3 highly unsaturated fatty acid is eicosapentaenoic acid or docosahexaenoic acid (column 3 lines 33 – 35) reads on instant claims 17 and 18.
Nakajima’s teaching that medium-chain fatty acids are constituent fatty acids in the triglyceride (column 4 line 65 to column 5 line 5) reads on instant claim 19. As noted above, “medium-chain fatty acids” are defined as having carbon chains of 8 – 12 (instant specification paragraph 0029), therefore, Nakajima’s teaching for medium-chain fatty acids reads on the limitation “wherein the medium-chain fatty acid is a C8 – C12 fatty acid”.
Nakijima’s teaching that the composition improves maximum oxygen intake and increases anaerobic threshold values, thus enhancing exercise capacity (abstract) reads on instant claim 20.
Nakajima’s teaching that the composition is in the form of a food (column 2 lines 41 – 47) reads on instant claim 21.
Conclusion
All claims are rejected. No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. EST.
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
