DETAILED ACTION
Claims 13, 18, and 29-31 are pending and under consideration on the merits.
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 10/28/2025 was filed prior to the mailing date of a first Action on the merits after the filing of an RCE. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, it was considered by the Examiner.
Status of the Rejections
The 103 rejections over Pertile and over Kim are maintained and expanded to include newly added claims 29-30.
The 35 USC 112(b) rejection is withdrawn in view of the amendment.
A new claim objection is applied to newly added claim 31.
Notice of Subject Matter Free of the Prior Art
Claim 31 is free of the prior art. As argued by Applicant, Example 4 demonstrates unexpected synergism of the claimed invention when Tetraselmis extract and niacinamide are present in a weight ratio of 1:333, which is viewed as reasonably commensurate in scope with the 1:400 to 1:300 weight ratio recited by claim 31.
Claim Objections
Claim 31 is objected to as depending from a rejected base claim, but would be in condition for allowance if rewritten in independent form and including all limitations of base claim 13.
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.
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.
Claims 13, 18, and 29-30 are rejected under 35 U.S.C. 103 as unpatentable over Kim et al. (J. Fish.Sci. Tech. 4(2), 75-83; published 12.31.2020) in view of Pertile et al. (US Pat. Pub. 2010/0143267; published 6.10.20).
As to claims 13, 18, and 29-30, Kim discloses a composition comprising a tetraselmis succica extract obtained by homogenization at a temperature of 80 degrees Celsius, which is within the range recited by claim 13, and wherein the extractant is water, which is the liquid extractant recited by claim 13 (page 77, 3rd full paragraph and Figure 1). The Office further notes that claim 13 is written in the form of a product by process claim, such that the patentability of the claim is determined by the structure of the composition as claimed and not by the method steps of making the composition that are recited by the claim. MPEP 2113. “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983) (The claims were directed to a zeolite manufactured by mixing together various inorganic materials in solution and heating the resultant gel to form a crystalline metal silicate essentially free of alkali metal. The prior art described a process of making a zeolite which, after ion exchange to remove alkali metal, appeared to be “essentially free of alkali metal.” The court upheld the rejection because the applicant had not come forward with any evidence that the prior art was not “essentially free of alkali metal” and therefore a different and unobvious product.).
Ex parte Gray, 10 USPQ2d 1922 (Bd. Pat. App. & Inter. 1989) (The prior art disclosed human nerve growth factor (b-NGF) isolated from human placental tissue. The claim was directed to b-NGF produced through genetic engineering techniques. The factor produced seemed to be substantially the same whether isolated from tissue or produced through genetic engineering. While the applicant questioned the purity of the prior art factor, no concrete evidence of an unobvious difference was presented. The Board stated that the dispositive issue is whether the claimed factor exhibits any unexpected properties compared with the factor disclosed by the prior art. The Board further stated that the applicant should have made some comparison between the two factors to establish unexpected properties since the materials appeared to be identical or only slightly different.).
As to claims 13, 18, and 29-30, Kim does not expressly disclose the mineral, mannitol, galactose, glucose, amino acid, or nitrogen content as recited by claim 13.
The Kim method, however, comprises virtually the same method steps disclosed by the present specification at paragraphs 74 and 101, using a process comprising the same source material and extraction solvents that are recited by the present claims and/or specification, and at temperatures within the recited range. Therefore, the close similarity of the Kim method suggests that the extract product should comprise similar ingredients, and in similar amounts, to those recited by the claims, such that the mineral, mannitol, galactose, glucose, amino acid, and nitrogen content of the extract is viewed as being within the ranges of claim 13, or, alternatively, as being sufficiently similar to the claimed ranges to render the present claims prima facie obvious as per MPEP 2144.05. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01. Additionally, differences in concentration generally will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As to claims 13, 18, and 29-30, Kim does not further expressly disclose that the amount of the Tetraselmis extract is within the range of claim 13 or that the composition comprises niacinamide and which is present within the range of claim 13 so as to generate a weight ratio range of the extract to niacinamide within the range of claim 13, nor the presence of one of the additional agents of claim 18 such as anti- acne, dandruff, or inflammatory agents or other sebum reducing agents (claim 18), nor that the product comprises auxiliary substances and/or perfumes (claim 29) and is a skin and/or hair care product (claim 30).
Pertile discloses a Tetraselmis suecica extract formed by a method comprising the steps of extracting viable, freeze-dried, or dried cells of Tetraselmis with a liquid extractant selected from hexane, ethyl acetate, ethanol, water, methanol, isopropanol, or mixtures, followed by removal of the cell material to obtain the extract (see claim 1 of Pertile). Pertile teaches that the extract is useful in a cosmetic composition for modifying the growth of human hair and/or the pigmentation of human skin and/or hair (paragraph 31), and that the composition may further comprise niacinamide as a skin and hair lightening agent (paragraph 76). The cosmetic composition may also comprise anti-acne, antidandruff, anti-inflammatory agents, or other sebum reducing agents and may be used for the treatment, care, and cleansing of the skin or hair (a “skin and/or hair care product” of claim 13)(paragraphs 66 and 69). Pertile teaches that the final composition most preferably comprises 0.1-5 wt% of the extract by total weight of the composition (paragraph 58), which overlaps the range of claim 13. Example 12 of Pertile is a working example of a hair care cosmetic product comprising 100 ppm Tetraselmis extract (i.e., 0.01 wt%, which is within the range of claim 13) and 0.2 wt % niacinamide (which is within the range of claim 13), which results in a Tetraselmis:niacinamide ratio of 1:20, which is within the recited ratio of claim 13. The cosmetic composition may further comprise anti-acne, antidandruff, anti-inflammatory agents, or other sebum reducing agents of claim 18 and which arealso auxiliary substances of claim 29 (paragraphs 66 and 69).
As to claims 13, 18, and 29-30, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the teachings of Kim by incorporating niacinamide and an anti-acne, dandruff, or inflammatory agents or other sebum reducing agents within amounts within the claimed ranges to form a skin or hair care product because Pertile expressly teaches that tetraselmis succica extracts in amounts within the presently claimed ranges are useful in skin care and hair care products for the modification of hair growth or hair or skin pigmentation and that are formulated with niacinamide as a skin lightener in amounts within the claimed ranges and which will result in a ratio of Tetraselmis extract to niacinamide that is within the presently claimed ratio, and further expressly discloses that anti- acne, dandruff, or inflammatory agents or other sebum reducing agents are also useful for incorporation into such a product. Additionally, discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Applicant’s Arguments
Applicant reiterates previous arguments that the claimed invention has an unexpected synergistic effect from the combined use of Tetraselmis extract with nacinamide which is not taught by the cited art. In response to the Office pointing out that the allegedly unexpected synergism demonstrated in Example 4 related to a composition comprising Tetraselmis extract and niacinamide that are outside of the presently claimed ranges, Applicant submits a Declaration stating that Example 4 represents a lab-scale testing to show synergy, wherein the amounts of Tetraselmis extract and niacinamide were scaled according to well-plate scale to provide a representative testing of amounts that would be used in standard applications to skin or hair. The declaration concludes that the skilled person would understand that it is inconsequential that the claims recite weight percentages of the extract and niacinamide that are not embodied in the example because given the sample size appropriate for well plates. The declaration states that Example 4 shows a synergy effect for a composition comprising 0.15 ppm Tetraselmis extract and 50 ppm niacinamide, corresponding to a weight ratio of 1:333 which is encompassed by the claimed ratio, and that the skilled artisan would readily understand that it is the weight ratio that is the significant factor in producing synergy, and that the Example 4 amounts would need to be scaled up accordingly at an appropriate weight ratio when producing a fully formulated product.
In response, whether unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) (Claims were directed to a process for removing corrosion at "elevated temperatures" using a certain ion exchange resin (with the exception of claim 8 which recited a temperature in excess of 100C). Appellant demonstrated unexpected results via comparative tests with the prior art ion exchange resin at 110C and 130C. The court affirmed the rejection of claims 1-7 and 9-10 because the term "elevated temperatures" encompassed temperatures as low as 60C where the prior art ion exchange resin was known to perform well. The rejection of claim 8, directed to a temperature in excess of 100C, was reversed.). See also In re Peterson, 315 F.3d 1325, 1329-31, 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003) (data showing improved alloy strength with the addition of 2% rhenium did not evidence unexpected results for the entire claimed range of about 1-3% rhenium); In re Grasselli, 713 F.2d 731, 741, 218 USPQ 769, 777 (Fed. Cir. 1983) (Claims were directed to certain catalysts containing an alkali metal. Evidence presented to rebut an obviousness rejection compared catalysts containing sodium with the prior art. The court held this evidence insufficient to rebut the prima facie case because experiments limited to sodium were not commensurate in scope with the claims.). MPEP 70602(d).
Here, and as discussed by the Declaration, Example 4 shows a synergy effect for a composition comprising 0.15 ppm Tetraselmis extract and 50 ppm niacinamide, corresponding to a weight ratio of 1:333. Base claim 13, however, encompasses a weight ratio range of from 1:500 to 1:10. The Office notes that a 1:10 ratio is 33-fold less than the 1:333 ratio of Example 4. The skilled artisan could not have reasonably extrapolated from the synergism from using a weight ratio of 1:333 of Example 4 and conclude that it would have also been present in a 1:10 weight ratio of claim 13. Therefore, the showing of synergism is not viewed as reasonably commensurate in scope with claim 13 based upon the evidence currently of record.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/BENNETT M CELSA/Quality Assurance Specialist , Art Unit 1600