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
The present application is a National Stage entry of International application PCT/CN2023/106944 filed 07/12/2023, which claims the benefit of Foreign application CN202210820950.3 filed 07/13/2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, although it is noted that no English translation was provided.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 01/13/2025, in the matter of Application N° 18/993,723. Said documents have been entered on the record. The Examiner further acknowledges the following:
Claims 1-11 are pending.
Claims 1-11 are presented for examination and rejected as set forth below.
Drawings
The drawings are objected to because Figure 1B is objected for being too dark and Figures 3(d), (e), and (f) appear blurry. All images/drawings would generally benefit from improved resolution, if possible and at the discretion of the Applicant.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claim 9 recites a “use”, which is not a statutory category. The Examiner interprets the claims to be read as a method claim of claim 1, that does not contain any active steps, and therefore does not further limit claim 1, which would additionally be considered improper (per 112(d); see MPEP 608.01(n)).
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 1-8 and 10-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature or natural phenomenon without significantly more.
Claims 1-8 and 10-11 simply recite a composition comprising hyaluronic acid (naturally-occurring) and yeast fermentation filtrate and/or lysate. Therefore, the instant claims recite a product of nature. Goldfeld (US20130251660A1) teaches yeast fermentation compositions are produced under aerobic and/or anerobic conditions in the presence of a yeast, carbohydrates, nutrients, water, which occurs naturally [0016-0024]. There is no evidence within the specification that the compositions recited in claims 1-8 and 10-11 contain markedly different characteristics from their naturally-occurring counterparts. Claim 5 does not resolve the product of nature rejection, because low molecular weight hyaluronic acid is found naturally, per Naya (2026): “Hyaluronic acid in its natural form has a molecular weight of 4,000 to 8,000,000 Daltons (Da) - an enormous range” (pg 4). Note that claim 9 is already rejected under 101 (see above).
This judicial exception is not integrated into a practical application because the instantly amended claims do not introduce any additional limitations which transform or improve on the judicial exceptions recited in claims 1-8 and 10-11 and do not do anything beyond generally linking the use of the judicial exception to a particular technological environment.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because compositions comprising the instantly claimed ingredients as pharmaceutical compositions, are well-understood as possessing routine, and conventional activity. Goldfeld (US20130251660A1) further teaches aqueous compositions comprising yeast fermentation mixtures and hyaluronic acid, as cosmetic for hair and/or skin (e.g., skin on the scalp) (abstract, [0001, 0041]). Claims 1-8 and 10-11 are directed to a judicial exception and do not qualify as eligible subject matter under 35 U.S.C. §101.
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.
Claims 1-11 are 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.
Claims 1-2 and 11 recite wt% ranges, but it has not been made clear if the wt% is in relation to another component or based on the total weight of the composition. Thus, these claims are incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. For the purpose of compact examination, the Examiner interprets wt%, as based on the total weight of the composition.
All claims that depend from claim 1 are additionally rejected.
Claims 2-5, 7, 9, and 11 recite exemplary language (e.g., preferably) that is indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP 2173.05(d). For examination purposes, the examples provided by the exemplary language are not considered limitations of the claim, and the broadest reasonable interpretation is used.
Claims 2-5 and 11 recite broad and narrow ranges, which is indefinite. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For examination purposes, the broadest range is used.
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.
Claims 1-4 and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Goldfeld (US20130251660A1), and in further view of Xie (CN104721129; machine translation provided) and Deszell (2011).
Applicant’s claims are directed to a moisture-locking and repairing composition for hair, wherein its functional components comprise a yeast fermentation product filtrate or lysate and a composite hyaluronic acid or a salt thereof, the content of the yeast fermentation product filtrate or lysate is 1-90wt%, and the content of the composite hyaluronic acid or a salt thereof is 1-20 wt%. Note that moisture-locking and repairing are considered intended uses of the composition that do not particularly provide patentable weight.
Goldfeld teaches skin care and hair care compositions [0001] such as hair cleansers (which affects both the scalp and hair follicle) [0041], comprising yeast fermentation derived mixtures (abstract), where the yeast components improve on current cosmetic products [0050].
Regarding claim 1: Goldfeld teaches yeast fermentation derived mixture (Goldfeld – claim 11) in 0.01% and about 20% [0037] and hyaluronic acid (Goldfeld – instant claim 17). The “moisture-locking” and/or “repairing” aspect is an intended use and does not provide patentable weight in a composition claim.
Regarding claim 8: Goldfeld teaches water makes up the balance (Table 1, [0048]).
Regarding claim 9: Goldfeld teaches a hair cleanser [0041], with good rinsability [0013].
Regarding claim 10-11: The further incorporation of the instant composition 1 into a hair product, implies a dilution of the initial composition to make a finished product, which is made obvious by Goldfeld’s secondary dilution performed in Table 2 [0050] and the finished products listed, including a hair cleanser [0041], whereby the instant ranges were previously made obvious (i.e., 0.01% and about 20% [0037] and hyaluronic acid (Goldfeld – instant claim 17)). With regard to the numerical range, note that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) (see 2144.05(I)).
In summary, Goldfeld teaches aqueous compositions comprising yeast fermentation mixtures and hyaluronic acid, as cosmetic for hair and/or skin (e.g., skin on the scalp). However, Goldfeld does not teach the amount of hyaluronic acid (instant claim 1 and 2), the terms filtrate/lysate or the source of fermentation (instant claim 1 and 7), and the specific ratio of yeast to hyaluronic acid (instant claim 3-4).
Xie teaches a moisturizing/hydrating cosmetic composition (abstract), that comprises 7-14 wt% (i.e., 7-14 weight parts) of rice and yeast fermentation (from filtrate), and hyaluronic acids 1-5 wt% (i.e., a 7 part yeast to 5 part hyaluronic acid mixtures, fall within the broader instant ranges of claims 3 and 4). Thus, by the description of the “filtrate” term, it is obvious to a PHOSITA that the filtrate comes from the process of fermenting rice with yeast (reads on claim 7).
Deszell, additionally, teaches SK-II, whereby this cosmetic, contains Pitera (i.e., brand name of a fermented yeast), which “boosts” the work of hyaluronic acid to be very moisturizing, thus motivating the specific combination of fermented yeast and hyaluronic acid, as obvious (pg 2).
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 modify Goldfeld’s composition to use yeast fermentation from filtrate and a certain amount/ratio of hyaluronic acid, as taught by Xie, because Xie teaches compositions that incorporate appropriate yeast fermentation from filtrate and hyaluronic acid amounts are moisturizing/hydrating cosmetic compositions, which relates to Goldfeld’s disclosure that demonstrates application to skin and hair care [0001], with moisturizing properties [0050]. Furthermore, Deszell additionally teaches SK-II, whereby this cosmetic contains Pitera (i.e., fermented yeast), which “boosts” the work of hyaluronic acid to be very moisturizing, thus rendering the combination as obvious (pg 2).
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Goldfeld (US20130251660A1), Xie (CN104721129; machine translation provided) and Deszell (2011), as applied to claims 1-4 and 7-11 are above, and in further view of Mastrodonato (US20100003311A1).
As discussed above, the combined Prior Art teaches moisturizing hair and skin care compositions that comprise yeast filtrate mixtures in combination with hyaluronic acid in obvious amounts. However, they do not teach the molecular weight of hyaluronic acid (instant claim 5) or the salt forms of hyaluronic acid (instant claim 6).
Mastrodonato teaches hyaluronic acid compositions (abstract) for incorporation into shampoos, etc. [0037], where the hyaluronic acid is used in any suitable amount [0038], because it is a topical antimicrobial agent [0010], which aids in cleaning functions. Mastrodonato teaches low and high MW hyaluronic acid that ranges of 1 and 10 kDa and less than 100 kDa for hyaluronic acid (reads on instant claim 5) [0011]. Furthermore, Mastrodonato teaches that hyaluronic acid and salts of hyaluronic acid are functionally equivalent in shampoos for example [0037], including sodium, magnesium or calcium salts (reads on instant claim 6) [0012].
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 modify the compositions of the combined Prior Art to specify a hyaluronic acid to have the molecular weight and/or salt form, as discussed by Mastrodonato, because Mastrodonato teaches that hyaluronic acid and salts of hyaluronic acid are functionally equivalent in shampoos for example [0037], including sodium, magnesium or calcium slats [0012], and that low and high MW hyaluronic acid that ranges of 1 and 10 kDa and less than 100 kDa for hyaluronic acid [0011] are also suitable for shampoos [0037], by acting as a topical antimicrobial agent [0010], which is beneficial in hair care products described by Goldfeld such as hair cleansers [0041]. Additionally, it merely specifies as subgroup of hyaluronic acid, whereby the generic hyaluronic acid genus is taught as obvious by Goldfeld and Xie.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAJAN PRAGANI whose telephone number is (703)756-5319. The examiner can normally be reached 7a-5p EST (M-Th).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.P./Examiner, Art Unit 1614 8/24/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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