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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-8) in the reply filed on February 9th, 2026 is acknowledged.
Claims 9 an withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 9th, 2026. The requirement is deemed proper and is therefore made FINAL.
Claims 1-8 were examined on the merits.
Information Disclosure Statement
The information disclosure statement filed August 7th, 2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because of illegible text in Figures 2 and 4 of de Campos et al. (BMC Res Notes 2025, 8, 269), possibly from inadequate scanning resolution. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
A copy of de Campos et al. (BMC Res Notes 2025, 8, 269) has been supplied and cited on the PTO-892 form.
Drawings
The drawings were received on November 14th, 2023. These drawings are acceptable.
Specification
The use of the terms ANOVA, Dun, SkinScanner, Gibco, Thermo Scientific, SICOL, and Biocolor; each of which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, each term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1-4 and 6 objected to because of the following informalities: lists are recited with the following incorrect punctuation pattern: A, B, C and/or D; for proper punctuation, correct to A, B, C, and/or D; for instance: "Casearia sylvestris, Schinus terebinthifolius, Hymenaea courbaril, Lactobacillus and cosmetically acceptable adjuvants" (claim 1) should be corrected to "Casearia sylvestris, Schinus terebinthifolius, Hymenaea courbaril, Lactobacillus, and cosmetically acceptable adjuvants"; and "extract, oil or butter" (claim 6) should be corrected to "extract, oil, or butter". Appropriate correction is suggested.
Claim 5 is objected to because of the following informalities: the phrase "in the form of a cream, gel, suspension, emulsion, elixir, serum, oil, ointment" should be changed to "in the form of a cream, gel, suspension, emulsion, elixir, serum, oil, or ointment" for correct punctuation and grammar. Appropriate correction is suggested.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The term “adjuvant” (instant claim 1) is understood as overlapping with the term “vehicle” given the broadest generally accepted meanings of these terms, and the examples of adjuvants in the instant specification (paragraph [26]) some of which (such as oils, solubilizers, water, and glycerin) have utility as vehicles for spreading a cosmetic composition over skin. The list in instant claim 5 “cream, gel, suspension, emulsion, elixir, serum, oil, ointment” is interpreted by the examiner as a list of alternative forms, because it is preceded by the phrase “in the form of a”, where “the form” is singular. The activity of “treating signs resulting from skin aging” (instant claim 8) is understood to overlap with anti-aging activity, because anti-aging activity reasonably results in a diminishing of the signs of skin aging.
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 and 5-8 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are: the characteristic referred to in the composition. What is meant by “characterized” in the composition. The examiner suggests removing the word “characterized” and reciting in the affirmative the composition: its physical form (claim 5), components (claims 1, 6, and 7), and its intended use (claim 8).
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 8 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating signs resulting from skin aging, does not reasonably provide enablement for preventing signs resulting from skin aging. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a cosmetic composition comprising Casearia sylvestris, Schinus terebinthifolius, Hymenaea courbaril, Lactobacillus, and cosmetically acceptable adjuvants, for use in preventing and/or treating signs resulting from skin aging. Thus, the claims taken together with the specification imply the instantly claimed composition prevents signs resulting from skin aging.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
Zhang and Duan (Cell Transplantation 2018, 27 (5), 729–738) recite "Telomeres are repetitive nucleotide sequences that cap and save the ends of chromosomes from degradation and abnormal recombination. They become shorter with each cell division and ultimately result in cellular senescence and limited numbers of cell division. Telomerase is an enzyme that adds telomere repetitions to the end to prevent telomeres from getting shorter. Telomerase-deficient mice exhibited accelerated telomere shortening, resulting in defective tissue regeneration. Moreover, proliferation capacity of epidermal stem cells with short telomeres was suppressed, whereas telomerase reintroduction in mice with critically short telomeres is sufficient to correct epidermal stem cell defects4” (page731, Telomere Shortening).
Zhang and Duan further recite “Although telomerase activation seems to be an ideal approach to reverse skin aging, and indeed high-level expression of telomerase reverse transcriptase (TERT) in skin fibroblasts and keratinocytes results in a significantly enhanced proliferative capacity85, but risks of epidermal carcinogenesis increase meanwhile86” (page 734, Telomere Modification).
Since the prevention of telomere shortening without increasing cancer risk remains largely unsolved, means for preventing signs of skin aging that result from telomere shortening is highly unpredictable.
(5) The relative skill of those in the art:
The relative skill of those in the art is high. Zhang and Duan recognize the utility of topically-applied tretinoin in suppressing the expression of MMPs and preventing the degradation of collagen (page 733, Retinoids), but also recognize the cancer risk induced by telomerase activation (page 734, Telomere Modification).
Accordingly, one would have turned to the instant disclosure for additional direction and guidance.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided examples of treating signs of skin aging. However, the specification does not provide examples of preventing the (otherwise inevitable) shortening of telomeres with cell division, and thereby preventing the resulting cell senescence and signs of skin aging.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Zhang and Duan and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to prevent signs of skin aging.
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 are rejected under 35 U.S.C. 101 because the claimed invention is directed to materials from without significantly more. The claim(s) recite(s) a cosmetic . This judicial exception is not integrated into a practical application because the applicant has not provided evidence in the specification that the claimed compositions significantly improve the therapeutic efficacy of the claimed product of nature. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed product of nature is embodied merely comprising materials routinely used in cosmetic compositions (cosmetically acceptable adjuvants).
The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since claims 1-8 are directed to a composition comprising materials from recited plants and bacteria (instant claim 1), the claims are directed to a composition.
Effective January 7, 2019, subject matter eligibility determinations under 35 U.S.C. § 101 follow
the procedure explained in the Federal Register notice titled 2019 Revised Patent Subject Matter
Eligibility Guidance (Federal Register, Vol. 84, No.4, 50-57), which is found at:
https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf. Applicants are kindly asked
to review this guidance as well as MPEP 2106.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines,
manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject
matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The
Office released guidance on December 16, 2014 for the examination of claims reciting natural products
under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular
Pathology v. Myriad Genetics, Inc. (569 U.S. ___, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)) and
Mayo Collaborative Services v. Prometheus Laboratories (566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d
1961 (2012)), Diamond v. Chakrabarty, 447 U.S. 303 (1980)) and Funk Brothers Seed Co. v. Kalo Inoculant Co. - 333 U.S. 127 (1948)). (inter alia). See eg. MPEP 2106.04(b)
The Supreme Court has explained that the judicial exceptions reflect the Court’s view
that abstract ideas, laws of nature, and natural phenomena are "the basic tools of scientific and
technological work", and are thus excluded from patentability because "monopolization of those
tools through the grant of a patent might tend to impede innovation more than it would tend to
promote it." Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980 (quoting Myriad, 133 S. Ct. at
2116, 106 USPQ2d at 1978 and Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S.
66, 71, 101 USPQ2d 1961, 1965 (2012)). The Supreme Court’s concern that drives this
"exclusionary principle" is pre-emption. Alice Corp., 134 S. Ct. at 2354, 110 USPQ2d at 1980.
The Court has held that a claim may not preempt abstract ideas, laws of nature, or natural
phenomena; i.e., one may not patent every "substantial practical application" of an abstract
idea, law of nature, or natural phenomenon, even if the judicial exception is narrow.
While preemption is the concern underlying the judicial exceptions, it is not a standalone
test for determining eligibility. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119
USPQ2d 1370, 1376 (Fed. Cir. 2016). Instead, questions of preemption are inherent in and
resolved by the two-part framework from Alice Corp. and Mayo (the Alice/Mayo test referred to
by the Office as Steps 2A and 2B). It is necessary to evaluate eligibility using the Alice/Mayo
test, because while a preemptive claim may be ineligible, the absence of complete preemption
does not demonstrate that a claim is eligible.
Products of Nature: When a law of nature or natural phenomenon is claimed as a
physical product, the courts have often referred to the exception as a "product of nature".
Products of nature are considered to be an exception because they tie up the use of naturally
occurring things, but they have been labeled as both laws of nature and natural phenomena.
See Myriad 133 S. Ct. at 2116-17, 106 USPQ2d at 1979 (claims to isolated DNA held ineligible because they "claim naturally occurring phenomena" and are "squarely within the law of nature
exception"); Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 76 USPQ 280, 281
(1948) (claims to bacterial mixtures held ineligible as "manifestations of laws of nature" and
"phenomena of nature"). Step 2A of the Office’s eligibility analysis uses the terms "law of
nature" and "natural phenomenon" as inclusive of "products of nature".
It is important to keep in mind that product of nature exceptions include both naturally
occurring products and non-naturally occurring products that lack markedly different
characteristics from any naturally occurring counterpart. Instead, the key to the eligibility of all
non-naturally occurring products is whether they possess markedly different characteristics from
its closest naturally occurring counterpart.
When a claim recites a nature-based product limitation, examiners 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. Nature-based products, as used herein,
include both eligible and ineligible products and merely refer to the types of products subject to
the markedly different characteristics analysis used to identify product of nature exceptions.
The Markedly Different Characteristics Analysis
The markedly different characteristics analysis is part of Step 2A, because the courts use this
analysis to identify product of nature exceptions. If the claim includes a nature-based product
that has markedly different characteristics, then the claim does not recite a product of nature
exception and is eligible. If the claim includes a nature-based product that does not exhibit
markedly different characteristics from its closest naturally occurring counterpart in its natural
state, then the claim is directed to a "product of nature" exception (Step 2A: YES), and requires
further analysis in Step 2B to determine whether any additional elements in the claim add
significantly more to the exception.
Nature-based Product Claim Analysis
Where the claim is to a nature-based product by itself, the markedly different
characteristics analysis should be applied to the entire product. Where the claim is to a nature-
based product produced by combining multiple components, the markedly different
characteristics analysis should be applied to the resultant nature-based combination, rather than
its component parts. Where the claim is to a nature-based product in combination with non-
nature based elements, the markedly different characteristics analysis should be applied only to
the nature-based product limitation. For a product-by-process claims, the analysis turns on whether the nature-based product in the claim has markedly different characteristics from its
naturally occurring counterpart.
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, and are evaluated based
on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-
based product limitation does not exhibit markedly different characteristics, then that limitation is
a product of nature exception. If the analysis indicates that a nature-based product limitation
does have markedly different characteristics, then that limitation is not a product of nature
exception. Because the markedly different characteristics analysis compares the nature-based
product limitation to its naturally occurring counterpart in its natural state, the first step in the
analysis is to select the appropriate counterpart(s) to the nature-based product. When there are
multiple counterparts to the nature-based product, the comparison should be made to the
closest naturally occurring counterpart. When the nature-based product is a combination
produced from multiple components, the closest counterpart may be the individual nature-based
components of the combination. Because there is no counterpart mixture in nature, the closest
counterparts to the claimed mixture are the individual components of the mixture, i.e., each
naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281
(comparing claimed mixture of bacterial species to each species as it occurs in nature).
Markedly changed characteristics can include structural, functional, chemical changes.
In order to show a marked difference, a characteristic must be changed as compared to nature,
and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an
incidental change in a characteristic of the naturally occurring counterpart. Myriad, 133 S. Ct. at
2111, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, applicant must have
caused the claimed product to possess at least one characteristic that is different from that of
the counterpart. If there is no change in any characteristic, the claimed product lacks markedly
different characteristics, and is a product of nature exception.
Step 1: Determine if the claims are directed to one of the four statutory categories of patentable
subject matter identified by 35 U.S.C. 101: a process, machine, manufacture or composition of matter.
YES, the claims are directed to a composition of matter and a process, which are statutory categories
within at least one of the four categories of patent eligible subject matter.
Step 2A: PRONG ONE: Evaluate whether the claim recites a Judicial Exception (e.g., law of nature, natural phenomenon, or an abstract idea; see MPEP 2106.04). YES, the claims are product claims reciting something that appears to be a nature-based product (i.e., a composition comprising materials from recited plants and bacteria (instant claim 1)) which is not markedly different from the closest naturally-occurring counterpart (i.e., the individual nature-based products).
Because the claim states the nature-based products which are plant extracts the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claims recite the naturally occurring components from several listed plant species and the bacteria Lactobacillus (instant claim 1), specifically Lactobacillus plantarum (instant claim 7). This equates to a plant extract. The process of creating a plant extract is by partitioning the starting plant material into separate compositions based upon some property. The closest naturally occurring counterparts of extracted components are those same components when found existing in the plant in an unseparated form, even when purified and/or concentrated because they are chemically identical to the extracted compounds/components. All of these are naturally occurring in nature and are not markedly different from its naturally occurring counterpart in its natural state. The properties of the
nature-based product as claimed are not markedly different than the properties of these naturally
occurring counterparts found in nature as these activities would inherently be found in the plant they
come from. The components which would give the activities claimed in the instant invention would
inherently do the same in nature as there has been nothing done in the instant invention that would
make them act in any different way.
Step 2A: prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a)
identifying whether there are any additional recited elements in the claim beyond the judicial exception
and (b) evaluating those additional elements individually and in combination to determine whether the
claim as a whole integrates the exception into a practical application.
This judicial exception is not integrated into a practical application because the plant extract
composition is only comprising the nature-based components. The claims do not integrate the judicial
exceptions into a practical application because in this context, such integration for a claimed product
would be a physical form of the specific practical application instead of a more general composition that
is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more
than the judicial exception because these components and their activity are already found naturally
occurring in nature and the addition of an intended use does not impart any added benefit to the
compounds or integrate the composition into a practical application.
Step 2B evaluates whether the claim as a whole, amounts to significantly more than the recited
exception, i.e., whether any additional element, or combination of additional elements, adds an
inventive concept to the claim (see MPEP § 2106.05(b)).
The claims as a whole do not amount to more than the recited exceptions because there aren’t
any other additional elements to consider, which does not add an inventive concept to the claims. Thus,
the claims are not eligible subject matter under current 35 U.S.C. 101 statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Paes et al. (US 20200315950 A1), and further in view of Chen et al. (US 20190247295 A1), Estevão et al. (Acta Cir Bras. 2017, 32 (9), 726-735), and De Oliveira et al. (BR-112019009838-A2).
Claim 1 recites “A cosmetic composition characterized in that it comprises Casearia sylvestris, Schinus terebinthifolius, Hymenaea courbaril, Lactobacillus and cosmetically acceptable adjuvants”. Claim 2 recites “The cosmetic composition according to claim 1, characterized in that it comprises from 0.00 1 to 5% Casearia sylvestris, from 0.00 1 to 5% Schinus terebinthifolius, from 0.00 1 to 5% Hymenaea courbaril and from 0.00 1 to 2% Lactobacillus by weight of the composition”. Claim 3 recites “The cosmetic composition according to claim 1, characterized in that it comprises from 0.00 1 to 0.2% Casearia sylvestris, from 0.00 1 to 1% Schinus terebinthifolius, from 0.00 1 to 1 % Hymenaea courbaril and from 0.00 1 to 1 % Lactobacillus by weight of the composition”. Claim 4 recites “The cosmetic composition according to claim 2, characterized in that it comprises 0.1 % Casearia sylvestris, 0.025 % Schinus terebinthifolius, 0.25% Hymenaea courbaril and 0.5% Lactobacillus by weight of the composition”. Claim 5 recites “The cosmetic composition according to The cosmetic composition according to characterized in that it is in the form of a cream, gel, suspension, emulsion, elixir, serum, oil, ointment”. Claim 6 recites “The cosmetic composition according to The cosmetic composition according to characterized in that Casearia sylvestris and Schinus terebinthifolius are in form of an extract and Hymenaea courbaril in the form of extract, oil or butter”. Claim 7 recites “The cosmetic composition according to claim 1, characterized in that the Lactobacillus is selected from Lactobacillus plantarum”. Claim 8 recites “The cosmetic composition according to The cosmetic composition according to characterized in that it is for use in preventing and/or treating signs resulting from skin aging”.
Paes et al. recites the following composition:
“1. A composition for modulating genes responsible for the general functions of the skin, characterized by comprising at least one plant extract and at least one cosmetically acceptable vehicle.
2. The composition according to claim 1, characterized in that said plant extract is selected from the group consisting of Acmella oleracea (spot flower), Avena sativa, Camellia sinensis (green tea), Casearia sylvestris (guaçatonga), Cichorium intybus (chicory), Hymenaea courbaril (courbaril tree), Paeonia albiflora (peony), Passifloraceae (passionflower), Schinus terebinthifolius (California pepper tree), Secale cereal extracts; or combinations thereof” (claims 1 and 2; instant claims 1 and 6), and recites the intended use of their invention “Accordingly, the compositions according to the present invention efficiently act on cell differentiation and proliferation, providing its use in cosmetic applications in the skin in general” (Paes et al., paragraph [0066]; instant claim 1).
Paes et al. further recites: “The compositions of the present invention are preferably anti-sign cosmetic compositions and can be in the form of gel, gel cream, elixir, serum, inter alia, as known by those skilled the art from the used cosmetic vehicles” (paragraph [0067]; instant claims 1 and 5).
Paes et al. also recites “In amounts of about 0.25% of courbaril tree xyloglucan and about 1.5% of a mixture of sodium cocoyl amino acids and sarcosine and potassium aspartate and magnesium aspartate, a synergistic modulation occurs in such genes, particularly in modulating the expression of collagen, elastin protein and/or expression of hyaluronic acid protein, providing its use in cosmetic applications in the skin in general” (paragraph [0059]; instant claims 2-4), where the courbaril tree is Hymenaea courbaril (paragraph [0029]; instant claims 2-4).
Paes et al. also recites “In amounts of about 0.1% of Casearia sylvestris, about 0.025% of Schinus terebinthifolius and about 5% of hyaluronic acid, a synergistic modulation occurs in such genes, particularly in modulating the expression of the collagen I, elastin, ki-67 and involucrin proteins, providing its use in cosmetic applications in the skin in general” (paragraph [0064]; instant claims 2-4).
Although Paes et al. does not recite a composition comprising Lactobacillus plantarum, Chen et al. recites “Collagen and ceramide in skin will lose gradually under the influence of age growth or bad habits, so complement and restoration of collagen and ceramide contents in skin is relatively important for the skin care, wrinkle-resistance, anti-UV damage, anti-aging. Through the in vitro experiments, the evaluation from the present invention found that Lactobacillus plantarum GMNL-6 can promote the secretion of collagen and the expression of ceramide synthase, representing that GMNL-6 has the special effects on the skin” (paragraph [0063]). Although Paes et al. does not recite the activities of Casearia sylvestris, Schinus terebinthifolius, and Hymenaea courbaril as individual components; relevant activities are recited by De Oliveira et al. and Estevão et al. De Oliveira recites Casearia sylvestris and Hymenaea courbaril having activity against cellular senescence, i.e. cellular aging (paragraphs [0015]-[0025]) and Estevão recites, in the context of a wound-treatment model, that Schinus terebinthifolius Raddi leaves oil treatment significantly increased collagen fibers deposition, as compared to control group (Abstract, Results paragraph). Considering the importance of collagen restoration in the skin for wrinkle-resistance and anti-aging of record above, it would have been obvious to one of skill in the art that Lactobacillus plantarum GMNL-6 and Schinus terebinthifolius have some activity against skin aging.
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to combine the instant ingredients for their known benefit since each is well known in the art for the same purpose and for the following reasons: Casearia sylvestris, Schinus terebinthifolius, Hymenaea courbaril, and Lactobacillus plantarum, are individually thought to possess activities against skin aging. In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton."). The Supreme Court thus implicitly endorsed the principle, stated in In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) (citations omitted), that: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art” (instant claims 1, 7, and 8).
Although Paes et al. and Chen et al. do not recite a composition that is 0.5 % Lactobacillus by weight, this weight percentage is obvious over routine optimization (instant claims 2-4). One of skill in the art could weigh cultured Lactobacillus material and other materials to be mixed therewith to control the weight percentage of Lactobacillus in the composition. One of skill in the art could then apply compositions comprising different weight percentages of Lactobacillus to test subjects, and use a high-order digital skin detector for analysis of wrinkles (Chen et al., paragraph [0062]). This experimentation would demonstrate which composition is optimal for treating the signs resulting from skin aging.
Paes et al., Chen et al., De Oliveira et al., and Estevão et al. are relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teachings provided by the references with respect to providing the weight percentages of Casearia sylvestris, Schinus terebinthifolius, Hymenaea courbaril, and Lactobacillus, the adjustments of particular conventional working conditions (e.g., the selection from among known components and determining one or more suitable ranges (amounts, proportions, ratios thereof) in which to provide the cosmetic 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 Paes et al. in view of Chen et al., De Oliveira et al., and Estevão et al.; the invention as a whole, drawn to a cosmetic composition as described in Claim 1, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing
Applicants’ composition with the composition of the prior art, the burden is on applicant to show
a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “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).
Conclusion
No claims are allowed.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655