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 .
Priority
This application was filed on and is a U.S. national Stage application under 35 U.S.C. 371 of International Patent Application No. PCT/KR17/13749 filed 11/29/2017, which claims the benefit of the priority of Korean Patent Application No. 10-2017-0126876 filed 09/29/2017.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 7 is amended. Claims 1-6, 8-13, 19-20, 24-31, 33-35 are canceled. Claims 39-46 are new. Claims 7, 14-16, 18, 21-23, 32, and 36-46 are being examined on the merits in this office action.
Examiner notes that claim 38 contains the status identifier “New”. However, claim 38 needs to be listed as “Previously Presented” since the claim is not new.
Claim Objections - Withdrawn
The objection of claims 7, 19, and 32 is withdrawn in view of the claim amendments and because claim 19 is canceled.
Claim Rejections - Withdrawn
The rejection of claims 2-4, 7-8, 14-16, 18-19, 21-25, 32, and 36-38 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the claim amendments.
The rejection of claims 2-4 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, is withdrawn because the claims are canceled.
The rejection of claims 2-4, 7-8, 18-19, 21-25, and 38 under 35 U.S.C. 102(a)(1) as being anticipated by Jim Caras (US20220160648A1 – hereinafter “Caras”) is withdrawn in view of the claim amendments.
The rejection of claims 14-16, 32, and 36-37 under 35 U.S.C. 103 as being unpatentable over Jim Caras (US20220160648A1 – hereinafter “Caras”) as applied to claim 7 above, and further in view of Nelson (What Is Hydrolyzed Collagen? Plus 7 Proven Benefits - Levels – published 04/14/2022) is withdrawn in view of the claim amendments.
The rejection of claims 7, 15-16, 18, 21-23, and 36-38 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9 of copending Application No. 18/861,616 in view of Nelson is withdrawn in view of the claim amendments.
Claim Rejections - 35 USC § 103 - New
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.
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.
Claim Interpretation
Claim 7 recites the transitional phrase “consisting essentially of”. "A ‘consisting essentially of’ claim occupies a middle ground between closed claims that are written in a ‘consisting of’ format and fully open claims that are drafted in a ‘comprising’ format." PPG Industries v. Guardian Industries, 156 F.3d 1351, 1354, 48 USPQ2d 1351, 1353-54 (Fed. Cir. 1998). See also Atlas Powder v. E.I. duPont de Nemours & Co., 750 F.2d 1569, 224 USPQ 409 (Fed. Cir. 1984); In re Janakirama-Rao, 317 F.2d 951, 137 USPQ 893 (CCPA 1963); Water Technologies Corp. vs. Calco, Ltd., 850 F.2d 660, 7 USPQ2d 1097 (Fed. Cir. 1988). For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." (MPEP 2111.03).
Further, Examiner notes that it is known in the art that collagen hydrolysate and collagen peptides are terms used interchangeably and are referring to the same compound. See also instant specification Page 6, line 8-9. Thus, any prior art that teaches the use of collagen peptide, would read on collagen hydrolysate.
Claims 7, 14-16, 21-23, 32, 36-46 are rejected under 35 U.S.C. 103 as being unpatentable over Yong et al. (CN101168051A – hereinafter “Yong”) in view of Nelson (What Is Hydrolyzed Collagen? Plus 7 Proven Benefits - Levels – published 04/14/2022) and Charest et al. (Sleep Med Clin. 2020 Mar;15(1):41–57) and IPAQ (https://www.physio-pedia.com/images/c/c7/Quidelines_for_interpreting_the_IPAQ.pdf -published 2004).
The teaching of the CN101168051A publication are based on the English language translation of the CN101168051A publication obtained by WIPO and the citations are based on the English language translation.
Yong teaches the use of collagen peptide showed an improved effect on symptoms such as fatigue, forgetfulness and sleep and that the symptoms were significantly reduced (Page 5, section 5 and Table 6).
Yong does not explicitly teach that the collagen peptide was administered to athletes and does not teach the frequency of exercise.
However, since Yong teaches that collagen peptide improved sleep, one of ordinary skill in the art would be motivated to administer it to athletes since it is known the art that athletes still experience inadequate sleep as taught by Charest.
Charest teaches that numerous athletes still experience inadequate sleep and that athletes’ quality of sleep appears to be lower than their non-athlete peers. Charest teaches that athletes such as NFL players have higher rates of obstructive sleep apnea, which has tremendous deleterious impacts on health and daytime sleepiness (Introduction section).
Further, Nelson teaches collagen hydrolysate is popular among athletes and has been used to decrease joint pain for athletes (Page 4). Nelson further teaches that collagen hydrolysate can be used to provide better night rest and that it improves sleep quality, reduce the time it takes to get to sleep, lessen daytime sleepiness the next day, improve memory performance the next day and decrease fatigue the next day and the dose is about 3 mg (Page 6).
Regarding the frequency of exercise, IPAQ teaches scores of 2 or 3 correlates to 7 days of exercise for a total of over 3000 minutes (Page 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Yong and administer collagen peptide to athletes since it is known in the art that numerous athletes still experience inadequate sleep and Nelson teaches that collagen hydrolysate which is popular among athletes, has been used to improves sleep quality (Page 6). It would have been obvious to use the collagen peptide on athletes that exercise at the frequency and having the IPAQ score taught by IPAQ since it is known that athletes still experience inadequate sleep as taught by Charest. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in using collagen peptide on athletes so as to help with sleep improvement. Examiner notes that compositions that essentially comprise collagen hydrolysate or collagen peptide are known to ameliorate sleep. One of ordinary skill in the art would be motivated to use collagen hydrolysate or collagen peptide on a subject who needs sleep ameliorated including athletes. The disclosures render obvious claim 7.
Regarding claims 14 and 32, Nelson teaches that the collagen hydrolysate is administered before bed (Page 7). Examiner notes that “before bed” also reads on 2-4 hours before bedtime thus rendering obvious claims 14 and 32. It would have been obvious to administer collagen hydrolysate a few hours before bed as taught by Nelson since Nelson teaches that the effect of improved sleep was realized when the collagen hydrolysate was administered before bed (Page 7, section 6, last line).
Regarding claims 15 and 36, Nelson teaches collagen hydrolysate can be used to provide better night rest and that it improves sleep quality, reduce the time it takes to get to sleep, lessen daytime sleepiness the next day, improve memory performance the next day and decrease fatigue the next day and the dose is about 3 mg (Page 6) Nelson further teaches that’s sleep benefits were experienced when collagen hydrolysate was administered at a dose of 10mg ((Page 7, section 6, last line). It would have been obvious to administer collagen hydrolysate at a dose 3 mg or 10 mg as taught by Nelson since Nelson teaches that collagen hydrolysate administered at that dose led to improved sleep quality.
Regarding claims 16 and 37, Yong teaches that the collagen peptide is administered at a dose including 0.45 g/kg which is equivalent to about 30g for an adults at the dose is a daily dose (Page 3) which reads on every day.
Regarding claims 21-23, Yong teaches the use of collagen peptide showed an improved effect on symptoms such as fatigue, forgetfulness and sleep (Page 5, section 5 and Table 6). Further, Nelson teaches collagen hydrolysate can be used to provide better night rest and that it improves sleep quality, reduce the time it takes to get to sleep, lessen daytime sleepiness the next day, improve memory performance the next day and decrease fatigue the next day and the dose is about 3 mg (Page 6). It would have been obvious to administer collagen hydrolysate or collagen peptide to improve sleep quality.
Regarding claim 38, Charest teaches that some athletes are more prone to developing sleep difficulties such as sleep apnea (Introduction section). Since Yong teaches that collagen peptide improved sleep, it would have been obvious to one of ordinary skill in the art to use collagen peptide on athletes suffering from sleep apnea and would have had a reasonable expectation of success.
Regarding claims 39-40, Yong teaches the use of collagen peptide showed an improved effect on symptoms such as fatigue, forgetfulness and sleep (Page 5, section 5 and Table 6). Further, Nelson teaches collagen hydrolysate can be used to provide better night rest and that it improves sleep quality, reduce the time it takes to get to sleep, lessen daytime sleepiness the next day, improve memory performance the next day and decrease fatigue the next day and the dose is about 3 mg (Page 6). It would have been obvious to administer collagen hydrolysate or collagen peptide to improve sleep quality.
Regarding claim 41, Yong teaches that the collagen peptide is prepared in a composition such as a tablet, oral liquid or food (see claims 1-3). The composition appears to comprise only of collagen peptide.
Regarding claims 42-43, IPAQ teaches scores of 2 or 3 correlates to 7 days of exercise for a total of over 3000 minutes (Page 9). It would have been obvious to use the collagen peptide on athletes that exercise at the frequency and having the IPAQ score taught by IPAQ since that is the known frequency of most athletes.
Regarding claims 44-45, Nelson teaches collagen hydrolysate is popular among athletes and has been used to decrease joint pain for athletes (Page 4). Nelson further teaches that collagen hydrolysate can be used to provide better night rest and that it improves sleep quality, reduce the time it takes to get to sleep, lessen daytime sleepiness the next day, improve memory performance the next day and decrease fatigue the next day and the dose is about 3 mg (Page 6). It would have been obvious to use collagen hydrolysate on athletes to improve sleep.
Regarding claim 46, Yong teaches that the collagen peptide is administered at a dose of 0.225 g/kg (Page 3, 4th paragraph). Examiner notes that this about 15g for an adult human who weight 65kg.
Claims 18 is rejected under 35 U.S.C. 103 as being unpatentable over Yong et al. (CN101168051A – hereinafter “Yong”) in view of Nelson (What Is Hydrolyzed Collagen? Plus 7 Proven Benefits - Levels – published 04/14/2022) and Charest et al. (Sleep Med Clin. 2020 Mar;15(1):41–57) and IPAQ (https://www.physio-pedia.com/images/c/c7/Quidelines_for_interpreting_the_IPAQ.pdf -published 2004) as applied to claim 7 above, and further in view of Jianwei et al. (CN115363162A – hereinafter “Jianwei).
The teaching of the CN115363162A publication are based on the English language translation of the CN115363162A publication obtained by WIPO and the citations are based on the English language translation.
The teachings of Yong are disclosed above and incorporated herein by reference.
Yong does not teach the molecular weight of the collagen peptide as recited in claim 18 and does not teach the exercise frequency and IPAQ score as recited in claims 42-43.
Jianwei teaches collagen peptide in a composition such as a solid beverage (Page 3, line 1-2) and that subjects in outer space experience sleep deprivation and that the composition comprising collagen peptide effectively prevented sleep deprivation and lethargy (Page 52nd paragraph). Jianwei teaches that the subjects woke up feeling refreshed and relaxed, with improved energy and better sleep (Page 7, Example 5). Jianwei teaches that the collagen peptide has a molecular weight of 1000 to 3000 Daltons (claim 6; Page 4, 6th paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Yong and administer collagen peptide which has a molecular weight of 1000-3000 Daltons as taught by Jianwei since Jianwei teaches that a composition with the collagen peptide was effective in improving sleep. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in using collagen peptide on athletes so as to help with sleep improvement. The discloses render obvious claims 8.
Response to Arguments
Applicant’s arguments, see Applicant Argument, filed 09/30/2025, with respect to the rejection(s) of claim(s) 7, 14-16,18, 21-23, 32, 36-46 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Yong and Jianwei.
Conclusion
No claims are allowed.
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 Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/Examiner, Art Unit 1654 /LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654