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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Within the abstract of the present invention, the applicant uses the language “said”. Applicant must avoid using such phrases.
Appropriate correction is required.
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 1-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Claim 1 is indefinite because it states that it is drawn to an “active” ingredient but does not state what the ingredient is “active” for.
Claims 2, 4, and 5 are indefinite due to a lack of antecedent basis for the limitation “The cosmetic active ingredient” as recited in line 1 of the claims.
Claim 3 is indefinite because it is unclear what “glucose/mannose ratio greater than 60%” means; the specification does not list the exact meaning of the phrases. The claim does not specifically state a ratio. It is unclear if the applicant means 60% more glucose than mannose or 60% more mannose than glucose or some other interpretation. Thus, the metes and bounds of the claim are unclear.
Claim 3 is indefinite because it is unclear what “/” means. The specification does not list the exact meaning of “/” – if it means “and”, “or”, or “and/or”. Thus, the metes and bounds of the claim are unclear.
Claims 8-13 are indefinite because they are directed to a cosmetic “use”. “Use” type claims are not a statutory category of invention. Thus, it is unclear if the claims are a method or a composition. Thus, the metes and bounds of the claim are unclear. For the sake of examination, these claims are examined as a composition with an intended use because this is broadest reasonable interpretation of the claims and because the claims do not contain any active method steps.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 states that the extract of claim 1 “is capable of being obtained” by the listed steps. However, “capable of being obtained” indicates that all of the steps are optional. Thus, claim 5 does not require any further limitations to claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. It is suggested that applicant amend “is capable of being obtained” to deleted “capable of being” to clarify this issue.
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 1-13 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.
The claimed invention is directed to non-statutory subject matter. The claim(s) 8-13 does not fall within at least one of the four categories of patent eligible subject matter because “use” is not a statutory category; within claims 8-13 of the present invention, the “use” claims, claims 8-13 will be examined as a composition with an intended use.
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 plants 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 plant 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 plant matter away from the naturally-occurring ingredients, the result of extraction is still a mixture of ingredients which are naturally-found in the plant 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. 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 of improving 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 of treating 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.
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 atleast 0.01 to 30% of yeast cytoplasmic macromolecules based on dry weight (page 1, line 25-26).
Sanchez does not teach a S. cerevisiae extract that corresponds to the cytosolic fraction comprising oligo-glucans and does not teach a glucose/mannose ratio greater than 60%.
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 β-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 contains 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.
The references do not specifically teach glucose/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 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 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 large amount (more than 60%) of glucose and/or mannose compounds.
Claim(s) 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 a mechanical method to achieve the extracted form of S. cerevisiae.
Claim(s) 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 claims 1 and 5 of the present invention.
Claim(s) 6-13 is/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), teaches that the yeast extract is about 2-6% wt % based on the total weight of the personal care composition (abstract), teaches that extracts from S. cerevisiae can function topically to improve the appearance of skin (paragraph 0005), teaches that the composition containing S. cerevisiae reduces post-inflammatory hyperpigmentation, regulating the elasticity of skin (paragraph 0032), teaches improving skin appearance and/or feel (paragraph 0032), and Gruber also teaches regulating the elasticity of skin (paragraph 0032).
One of ordinary skill in the art would reasonably expect that the combination of 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, more specifically impacting the immune and vascular systems, and associated growth factors (also associated with the skin) as stated within claim 10 of the present invention. It would be obvious to one of ordinary skill in the art that the cutaneous vasculature (which is part of the skin structure) ([referring to vascular in claim 9 of the present invention]) functions to supply nutrients or substances to the skin to keep it healthy, therefore also making it obvious that the cosmetic composition that contains S. cerevisiae would encompass all of the components as stated within claims 6-13 of the present invention, in terms of improving the skin.
Conclusion
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
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655