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 .
Curently amended claim(s) 8-13 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claim(s) 8-13 are now drawn to a method of using the composition.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim(s) 8-13 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim(s) 1-7 are pending.
Withdrawn Objections
Applicant’s arguments filed May 29, 2026 have been fully considered. In regards to the objection of the abstract, applicant has submitted a replacement abstract that is in compliance and therefore, the objection of the specification has been withdrawn.
Withdrawn Rejections
Applicant’s arguments filed May 29, 2026 have been fully considered.
In regards to the rejection under 35 U.S.C. 112(b) for indefiniteness, applicant has amended the claims as appropriate. Thus, the rejection of claim(s) 1-7 under 35 U.S.C. 112(b) has been withdrawn.
In regards to the rejection under 35 U.S.C. 112(d) for improper dependent form, applicant has amended the claim as appropriate. Thus, the rejection of claim 5 under 35 U.S.C. 112(d) has been withdrawn.
Pending Rejection(s)
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(s) 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. A composition comprising a Saccharomyces cerevisiae (S. cerevisiae) extract of claim 1 encompasses naturally occurring substances.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant's claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant's claims recite an extract from S. cerevisiae is a naturally occurring fungus. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that "When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A."
MPEP § 2106.04(c)(I) states that "if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states "The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product's structure, function, and/or other properties…".
In this case, extraction of fungus only concentrates and portions the naturally occurring compounds in the fungus which are soluble or insoluble in the particular solvent. General extraction does not necessarily result in a markedly distinct change in the naturally occurring compounds from the fungus. Thus, while a solvent extract itself may not be found in the nature, the compounds which are present in the fungus and soluble in the selected solvent are found in nature. The creation of a solvent extract only partitions and concentrates the molecules that are naturally in the fungus. There is no evidence or reason to expect that any new compounds are formed. The extract itself is a mixture of the naturally occurring compounds that are simply soluble in a particular solvent. Thus, while extraction of the compounds with the selected solvent would separate a portion of the fungus matter away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally-found in the fungus material; i.e., the compound is not inventive or "man-made." Thus, the extract in turn is a mixture of the naturally occurring compounds found in the fungus. The extract from the fungus leads to a naturally occurring compound from the fungus. Thus, the claim is drawn to a naturally occurring product.
There is no indication that the specified extract as commensurate in scope with the stated claim changes the structure, function, or other properties of the extract in any marked way in comparison with the closest naturally occurring counterpart. The closest naturally occurring counterpart for the extract is a mixture of the naturally occurring compounds that are present in the extract. Because, as discussed above, the fungal extract contains only a mixture of the naturally occurring compounds found in the fungus. The extract composition appears to maintain its naturally occurring structure and properties and is merely present in the product. Thus, the claimed product as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts.
In regards to product-by-process claims please note that MPEP § 2106.4(c)(I)( B) states "For a product-by-process claim (e.g., a claim to a cloned farm animal produced by a nuclear transfer cloning method), the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its naturally occurring counterpart " Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant's claims are directed to a composition with an intended use for application to the skin. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to "an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the 'improvement of the skin' consideration." Therefore, applicant's intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by "Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself." In this case, the additional element in the claims is the presence of an extract. However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception.
Moreover, applicant's intended use for application to the skin using the extract of S. cerevisiae is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), "Generally linking the use of the judicial exception to a particular technological environment or field of use" is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
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.
Claim(s) 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez (WO 2019/158637 A1, Published August 22, 2019) in view of Hirayama et al (Journal of Biological Chemistry, (Year: 2010), vol. 285, issue. 16, pp. 12390-12404), and Williams et al (Carbohydrate Research, (Year: 1991), vol. 219, pp. 203-213).
Sanchez teaches that yeast [contains] cytoplasmic macromolecules (page 1, line 7), the yeast cytoplasmic macromolecules have a molecular weight >3 kDa (page 1, line 28), Sanchez also teaches [that] characterized in the composition comprises at least 0.01 to 30% of yeast cytoplasmic macromolecules based on dry weight (page 1, line 25-26).
Sanchez does not explicitly teach a S. cerevisiae extract that corresponds to the cytosolic fraction comprising oligo-glucans (as stated within claim 1 of the present invention). Sanchez does not teach that the cosmetic active ingredient according to claim 1, wherein the oligo-glucans represent between 10 and 35 wt.% dry matter of the extract (as stated within claim 2 of the present invention). Sanchez does not teach a glucose/mannose ratio greater than 60% (as stated within claim 3 of the present invention). Sanchez does not teach that the cosmetic active ingredient according to claim 1, wherein the extract is a mechanical lysate of Saccharomyces cerevisiae (as stated within claim 4 of the present invention). Sanchez does not teach the cosmetic active ingredient according to claim 1, wherein the cosmetic active ingredients being obtained by a method comprising the following steps (the steps that are recited within claim 5 of the present invention). Sanchez does not teach a cosmetic composition for topical application to the skin, the cosmetic composition comprising a therapeutically effective amount of at least one active ingredient according to claim 1 and a physiologically acceptable medium for application to the skin (as stated within claim 6 of the present invention). Sanchez does not explicitly teach that the active ingredient in liquid form represents at least 0.1 wt.% of the total weight of the composition (as stated within claim 7 of the present invention).
Hirayama et al teaches the extraction of cytosolic free oligosaccharides from yeast ([S. cerevisiae]) cells (page 12392).
Williams et al produced a table outlining the process for extracting ß-glucan from S. cerevisiae (figure 1).
The composition as taught by Sanchez can be modified to include the information that the yeast extract cytoplasm includes the cytosol that would contain free oligosaccharides as taught by Hirayama et al, organelles and any associated macromolecules, in which, macromolecules can also include β’glucan[‘s] as taught by Williams et al. In addition, one of ordinary skill in the art would reasonably expect for the extract that contains the S. cerevisiae would contain an amount of glucose to mannose greater than 60%, given that extraction tends to concentrate on specific components. Moreover, one skilled in biochemistry and molecular biology would also understand that polysaccharides (i.e. β-glucan) tend to be larger than oligosaccharides, however, polysaccharides can potentially be broken down into smaller oligosaccharides which is a technique that can be used by one skilled in the art to achieve such oligosaccharides.
The aforementioned references do not specifically teach a ratio of glucose to mannose in the amounts as claimed by applicant. However, as discussed in MPEP section 2144.05(II)(A), "Generally, differences in concentration or temperature 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)." The references teach the use of each of the ingredients in a pharmaceutical composition. Varying the concentration of ingredients within a composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the compounds produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant's claimed invention. One of ordinary skill in the art would reasonably expect that the combination of information from the aforementioned references would lead one to determine that an S. cerevisiae extract would contain macromolecules, including but not limited to oligo-glucans and glucans (also stated within page 9 of the specification of the current invention) that would enable one skilled in the art to modify the composition to have a reasonable molar mass that would represent no less than 10 and no more than 35 wt% dry matter of the extract, and lastly, would comprise a ratio of glucose to mannose greater than 60%.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Sanchez ((WO 2019/158637 A1, Published August 22, 2019) in view of Hirayama et al (Journal of Biological Chemistry, (Year: 2010), vol. 285, issue. 16, pp. 12390-12404) and Williams et al (Carbohydrate Research, (Year: 1991), vol. 219, pp. 203-213) as applied to claims 1-3 above, and further in view of Bunte Thomas (EP 0297457 A2 - English translation provided).
The teachings of Sanchez, Hirayama et al, and Williams et al are above.
Bunte Thomas teaches a mechanically obtained lysate of yeast cultures of the species Saccharomyces cerevisiae (abstract).
One of ordinary skill in the art would reasonably expect to use Bunte Thomas mechanical method in order to achieve the extracted form of S. cerevisiae.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sanchez ((WO 2019/158637 A1, Published August 22, 2019) in view of Hirayama et al (Journal of Biological Chemistry, (Year: 2010), vol. 285, issue. 16, pp. 12390-12404) and Williams et al (Carbohydrate Research, (Year: 1991), vol. 219, pp. 203-213) as applied to claims 1-3 above, and further in view of Taizo (JP 3847649 B2 - English translation provided).
The teachings of Sanchez, Hirayama et al, and Williams et al are above.
Taizo teaches that yeast may be homogenized in an extraction solvent ([such as water]) (paragraph 0022); Taizo also teaches that the yeast (S. cerevisiae) was filtered, concentrated and freeze-dried to obtain a yeast extract (paragraph 0074).
Claim 5 is considered a product-by-process claim and the product (in this case, S. cerevisiae) is not limited by the method of making. Therefore, the method as taught by Taizo to obtain an extract of S. cerevisiae is sufficient to reject this claim. "[T]he lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). One of ordinary skill in the art would reasonably expect that the method as taught by Taizo to obtain an extract of S. cerevisiae is sufficient to achieve the desired product, as stated within claim(s) 1 and 5 of the present invention.
Claim(s) 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Sanchez (WO 2019158637 A1 - English translation provided) in view of Hirayama et al (Journal of Biological Chemistry, (Year: 2010), vol. 285, issue. 16, pp. 12390-12404), Williams et al (Carbohydrate Research, (Year: 1991), vol. 219, pp. 203-213) as applied to claims 1-3 above, and further in view of Gruber (U.S. Pub No. US 2012/0128755 A1).
The teachings of Sanchez, Hirayama et al, and Williams et al are above.
Gruber teaches oil-in-water emulsion carriers ([which are also known as lotions or creams]) (paragraph 0024). Gruber teaches that the yeast extract is about 2-6% wt % based on the total weight of the personal care composition (abstract). Gruber teaches that extracts from S. cerevisiae can function topically to improve the appearance of skin (paragraph 0005). Gruber teaches other conventional skin care product additives may also be included in the compositions of the present invention [such as] jojoba oil (paragraph 0028).
One of ordinary skill in the art would reasonably expect that the combination of the aforementioned references would form a cosmetic composition using the active ingredient, S. cerevisiae that is contained within a physiologically acceptable medium, like an oil-in-water emulsion, as taught by Gruber that has the ability of improving the overall appearance of the skin.
Response to Arguments
Applicant’s arguments filed May 29, 2026 have been fully considered. The arguments regarding the rejection under 35 U.S.C. 101 for natural products and the rejection under 35 U.S.C. 103 for obviousness are found to be non-persuasive.
Regarding the 35 U.S.C. 101 rejection for natural products, applicant states “the active ingredient according to claim 1 does not comprise DNA or cell membrane and therefore it is structurally different from S. cerevisiae. The cosmetic active ingredient is also different chemically from S. cerevisiae because it is obtained from the cytosolic fraction of Saccharomyces cerevisiae yeast. It is therefore not the organism itself but rather an extract that has undergone a process carried out by the inventor to separate a fraction of interest. In particular, this extract is obtained by mechanical lysis as recited in claim 4 (as stated on page 7 of applicant arguments) … the cosmetic active agent is also different from a corresponding counterpart in nature because the cosmetic active agent has undergone man-made transformation in a process conducted by the inventor (as stated on page 8 of applicant arguments)”. Applicant arguments presented for the rejection under 35 U.S.C. 101 are more specific than the currently presented claims based on what is provided within pages 7 and 8 of applicant’s arguments. More specifically, regarding the discussion of “the active ingredient according to claim 1 does not comprise DNA or cell membrane [and] this extract is obtained by mechanical lysis as recited in claim 4. This process step is defined as the destruction of the membrane of a biological cell by a physical agent, such as a mechanical means, as opposed to a chemical or biological agent”, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). See MPEP 2145. In addition, given that the applicant also discusses the mechanical separation method used to separate a fraction of interest; generally speaking, the use of a mechanical separation process in order to achieve the extracted form of S. cerevisiae would not change the original structure or possess a materially different characteristic just because it was separated within a different environment. It is known in the art that there has to be some type of human or man-made interaction in order to achieve the extract, therefore, extraction serves to concentrate and portion the naturally occurring compounds in the fungus which are soluble or insoluble in the particular solvent. General extraction does not necessarily result in a markedly distinct change in the naturally occurring compounds from the fungus. Moreover, regarding claim(s) 6 and 7, the composition being applied to the skin comprising a physiologically acceptable medium such as water or a plant oil (i.e. jojoba oil) also does not create a markedly distinct characteristic. Thus, the presently amended claim(s) 1-7 are a product of nature that does not possess markedly different characteristics under Step 2A, Prong One due to there still having the components that are already naturally present within S. cerevisiae. Therefore, the rejection under 35 U.S.C. 101 for being directed to natural products/product of nature is maintained.
Regarding the rejection under 35 U.S.C. 103 for obviousness, applicant overall argues that the combination of Sanchez with Hirayama et al, Williams, Taizo and Gruber across claim(s) 1-7 “do not enable or motivate a person skilled in the art to specifically obtain oligo-glucans with molecular weights between 2 and 5 kDa derived from the cytosolic fraction of Saccharomyces cerevisiae as recited in claim 1 and its dependent claims (as stated in page 12 of arguments)”. The combination of all the aforementioned references within each of the respective claims does teach how to obtain the composition – which is an extract of S. cerevisiae; in addition, there is nothing unobvious to a person of ordinary skill in the art with the method(s) used in order to obtain the cosmetic active ingredients. In addition, given that the primary reference, Sanchez, does teach that the yeast cytoplasmic macromolecules have a molecular weight >3 kDa (page 1, line 28), that does not negate the fact that the cytoplasmic macromolecules found are still within the range of 2-5 kDa – the extracted molecules found will overlap with the ranges provided within claim 1 of the present invention thus Sanchez is still applicable. Moreover, although applicant also states that “in contrast to the cited art, the above-captioned patent application discloses a specific process which allows for production of an extract derived from the cytosol of S. cerevisiae, which differs from prior art extracts or the cytosol of S. cerevisiae in terms of its composition, the nature of molecules, molecular weight, and molecular distribution (as stated at the bottom of page 11 of applicants arguments)…[and that] a person skilled in the art would obtain a cytoplasmic extract containing numerous molecules larger than 3 kDa, derived from any Saccharomyces and would overlook the specific active ingredient which comprises oligo-glucans with molecular weights between 2 and 5 kDa (as stated towards the bottom of page 12 of applicants arguments)”. A person of ordinary skill in the field of biology would know that an extract of the cytoplasm would include that of the cytosol and the components that would be contained within it; in addition, given that the independent claim, namely claim 1 uses the term “comprises” this is open-ended and therefore, the applicant of the present invention leaves room for other components to naturally be present within an extract of S. cerevisiae which includes but are not limited to oligo-glucans that may be greater than 3 kDa but still falls within the range of 2-5 kDa, as stated within claim 1 of the present invention. Furthermore, applicant does state on page 9 of applicant arguments that “the active ingredient of claim 1 is a filtrate in which the yeast extract is filtered to retain only the cytosolic fraction containing only molecules of smaller size as recited in claim 1”. In this situation too, part of applicant’s remarks throughout this statement and some other statements throughout applicant’s arguments under 35 U.S.C. 103 are not commensurate in scope and that also, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). See MPEP 2145. Thus, the rejection under 35 U.S.C. 103 for obviousness is maintained.
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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NASHARA L MOREAUExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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