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 .
DETAILED ACTION
Applicant’s amendment in the reply filed on 5/8/26 is acknowledged. Claims 1-16 are pending. Claims 11-16 are withdrawn. Claims 1-10 are examined on the merits.
Any rejection that is not reiterated is hereby withdrawn.
Claim Rejections –35 USC § 112, 2nd
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.
Claims 1-10 are newly rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
This is a new rejection necessitated by the Applicant’s amendment filed on 5/8/26.
Claim 1 recites “A composition comprising low molecular weight hydrolyzed collagen and at least one proteinaceous amino acid, wherein the low molecular weight hydrolyzed collagen has a molecular weight of about 500-1,000 Daltons”. The recitation is very confusing, as hydrolyzed collagen itself is a proteinaceous amino acid, does Applicant mean to recite ““at least one proteinaceous amino acid selected from the group consisting of whey, whey isolate, and/or hydrolyzed whey”?
Therefore, the metes and bounds of claims are rendered vague and indefinite. The lack of clarity renders the claims very confusing and ambiguous since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
All other cited claims depend directly or indirectly from rejected claims and are, therefore, also, rejected under U.S.C. 112, second paragraph for the reasons set forth above.
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 1, 9, and 10 remain rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Yu et al (CN 108210975 A).
This rejection is maintained for reasons of record set forth in the Office Action mailed out on 1/9/26, repeated below, slightly altered to take into consideration Applicant’s amendment filed on 5/8/26. Applicants’ arguments filed have been fully considered but they are not deemed to be persuasive.
Yu et al teach a dressing liquid for treating acne, characterized in that the dressing liquid is mainly composed of 1 to 10 parts of marine hydrolyzed collagen (thus at least one protenaceous amino acid), 0.5 to 4 parts of dipotassium glycyrrhizinate, 0.2 to 1 part of aloe vera gel powder (thus claim 10 is met, thus an active agent), and prepared by 1000 parts of water (see claim 1). Yu et al teach the dressing liquid according to claim 1, wherein the molecular weight of said marine hydrolyzed collagen (thus claim 1 is met) is 400~1500 Daltons, such as 400 Daltons, 500 Daltons, 600 Daltons (thus the claimed 500-1000Da), 700 Daltons, 800 Daltons, 900 Daltons, 1000 Daltons, 1100 Daltons, 1200 Daltons, 1300 Daltons, or 1400 Daltons (see claim 3).
Yu et al teach in the half-face experiment, both individuals used the dressing described in Example 4 of this invention on the right half of their face (thus cosmetic, thus claim 9 is met), while the left half of their face served as a control [0090].
Yu et al teach acne can persist for years, causing disfigurement or leaving permanent scars and having a serious negative impact on a patient's psychological [0004].
Therefore, the reference is deemed to anticipate the instant claim above.
Applicant’s argument about Yu on pages 1-3 have been carefully considered, but they are not found persuasive.
First of all, “marine hydrolyzed collagen” itself in Yu et al is a “at least one proteinaceous amino acid”, thus the claim limitation is met. Applicant should have added “at least one proteinaceous amino acid selected from the group consisting of whey, whey isolate, and/or hydrolyzed whey” or “at least one additional proteinaceous amino acid selected from the group consisting of whey, whey isolate, and/or hydrolyzed whey”.
Secondly, the current claim 1 uses open language “comprising”, it does not preclude the presence of other components such as Dipotassium glycyrrhizate or aloe vera etc. to achieve any synergistic effect. If Applicant amends claim 1 using “consisting of” language, then the Yu et al reference is not qualified.
Thirdly, what is being claimed is a composition, not a method claim. What Yu et al teach acne is not relative.
Claim Rejections –35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-10 remain rejected under 35 U.S.C. 103(a) as being unpatentable over Yu et al as applied to claims 1, 9, and 10 above, and further in view of Petito (US 20160220645 A1).
This rejection is maintained for reasons of record set forth in the Office Action mailed out on 1/9/26, repeated below, slightly altered to take into consideration Applicant’s amendment filed on 5/8/26. Applicants’ arguments filed have been fully considered but they are not deemed to be persuasive.
The teachings of Yu et al are set forth above and applied as before.
The teachings of Yu et al do not specifically teach the incorporation of bovine source hydrolyzed collagen or a hydrolyzed whey in the composition; neither do Yu et al teach the claimed percentages of each different source or a therapeutic agent in claim 6, a medical food in claim 7, or nutritional supplement in claim 8.
Petito teaches the composition for tissue/cell repair facilitates healing of damaged tissues, promoting tissue and cell growth, protecting cells and tissues, and reducing scar tissue. The composition includes hydrolyzed collagen, and may include high molecular weight hydrolyzed collagen. The hydrolyzed collagen may be combined with native collagen and/or at least one other therapeutic agent. For example, the therapeutic agent may be a polysulfated glycosaminoglycan (thus claims 6 and 10 are met), a glucosamine salt, or mixtures thereof. The collagen may be derived from two or more different sources, and may be combined with hydrolyzed whey and/or elastin (see Abstract).
Petito teaches further examples of this wound healing composition optimized for different applications include: about 70% bovine sourced hydrolyzed collagen (thus claim 5 is met) and about 30% marine sourced hydrolyzed collagen; about 50% bovine sourced hydrolyzed collagen, about 30% marine sourced hydrolyzed collagen, and about 20% hydrolyzed whey (thus claim 2 is met); about 40% bovine sourced hydrolyzed collagen, about 20% marine sourced hydrolyzed collagen, about 20% hydrolyzed whey, and about 20% elastin; about 20% bovine sourced hydrolyzed collagen, about 40% marine sourced hydrolyzed collagen, about 20% hydrolyzed whey, and about 20% elastin; about 20% bovine sourced hydrolyzed collagen, about 40% marine sourced hydrolyzed collagen, and about 40% hydrolyzed whey; and about 30% bovine sourced hydrolyzed collagen, about 30% marine sourced hydrolyzed collagen, about 30% hydrolyzed whey, and about 10% elastin. The bovine hydrolyzed collagen can have a molecular weight of about 500 Daltons to about 10,000 Daltons [0029] (thus overlaps with the claimed 500-1000 Daltons).
Petito teaches the composition may be formulated as a nutritional supplement. For example, at least one of vitamin A, vitamin C, vitamin E, vitamin B12, magnesium oxide, chelated manganese, grape seed extract, zinc, an alginate, cellulose, honey, chromium picolinate, selenium, glutamine, and glycosaminoglycans can be added to the composition to produce a nutrient composition for oral intake [0036] (thus claims 7 and 8 are met).
Petito teaches the composition may be useful for applications relating to cosmetic and plastic surgery, e.g., as a filler for lines and wrinkles formed in the skin [0031].
Petito teaches the composition may take a physical form used in topical administration, such as a gel, spray, powder, paste, foam, film for incorporation in a dressing bandage, or a topically applied patch. The composition may take a physical form used in internal administration, such as an injectable liquid or an orally ingestible liquid [0032].
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the combination of bovine and marine sourced hydrolyzed collagen and hydrolyzed whey since Petito teaches to do so.
It would also have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the composition as medical food or nutritional supplement since Petito teaches to do so.
Since both of the references teach using marine sourced hydrolyzed collagen with a molecular weight of about 500-1000 Daltons in cosmetics regarding reducing scar tissue, one of ordinary skill in the art would have been motivated to make and use the invention.
Regarding the claimed amount of each component in claim 5, determining an appropriate amount of the components within the composition is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the references, it is apparent that one of the ordinary skills in the art would have had a reasonable expectation of success in producing the claimed invention.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Applicant’s argument about Petito on pages 3-4 have been carefully considered, but they are not found persuasive.
First of all, this is a 103 rejection instead of a 102 rejection, the primary reference Yu et al already meets the molecular weight requirement of a hydrolyzed collagen, Petito is used to meet the rest of the claim amendment. Secondly, Petito explicitly teach the bovine hydrolyzed collagen can have a molecular weight of about 500 Daltons to about 10,000 Daltons [0029], which overlaps with the claimed 500-1000 Daltons. Petito is allowed to have different embodiments that teach different molecular weight other the claimed range in current claims.
Applicant's arguments have been fully considered but they are not persuasive, and therefore the rejections in the record are maintained.
Conclusion
No claim is 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QIUWEN MI whose telephone number is (571)272-5984. The examiner can normally be reached on Monday-Friday 8:30 am to 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655
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