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 1-25, drawn to an anti-allergenic composition wherein the plant extract is selected from consisting of Camellia sinensis leaf extract and/or Melaleuca alternifolia leaf oil, in the reply filed on 04/03/2026 has been acknowledged. Claims 26-27 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention without traverse. The requirement is still deemed proper and therefore made FINAL.
Pending claims 1-25 are pending and have been examined on the merits.
Information Disclosure Statement
The information disclosure statements filed on July 1st, 2024 and August 27th, 2025 have been considered by the examiner. The signed IDS form is attached with the instant office action.
The information disclosure statement filed April 25th, 2026 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because of the reasons recited below. It has been placed in the application file, but the information referred to therein for the lined-through references 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).
Foreign patent document Cite No 1 appears to be missing
Foreign patent document Cite No 11 should have the document number 01/51048 per the document included in the file wrapper. Non-Patent Literature Cite No 1 is missing.
While not affecting the consideration of references, there appears to be duplicate references: U.S. Patent application Publications Cite Nos 4 and 7 are duplicates and Cite Nos 5 and 6 are duplicates; for Cite Nos 6 and 7 the applicant has listed inventor names in the box designated for the name of the patentee or applicant of the cited document.
The information disclosure statement filed August 15th, 2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because of the reasons recited below. It has been placed in the application file, but the information referred to therein for the lined-through references 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).
U.S. Patent Application publication Cite No 1 has a non-matching assignee and publication date: US-20210021293-A1 has the assignee Cable Vision Electronics Co., LTD and was published on January 21st, 2021. It is unclear what document the applicant intended to cite here.
Foreign patent document 1 appears to have an English language abstract that is only partly legible because the text is too small relative to the graphic resolution of the document.
While not affecting the consideration of the document, U.S. Patent Application publication Cite No 2 (US-20090300864-A1) has an inventor name listed in place of the patentee or applicant 20090300864.
Specification
The disclosure is objected to because of the following informalities: the term "Malaleuca" is misspelled; the term should be spelled "Melaleuca". Th.
Appropriate correction is required.
The use of the terms Brij, Pluronic, and USP, each of which is a trade name or a mark used in commerce, has been noted in this application. Each 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
Claim 1 is objected to because of the following informalities: the term "Malaleuca" is misspelled; the term should be spelled "Melaleuca". Th. 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 19 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The term “about” in claims 19 and 20 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The refractive index and specific gravity of the .
Claim 25 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. It is not clear whether the percents recited in claim 25 are weight/weight, weight/volume, or volume/volume.
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 1-24 are rejected under 35 U.S.C 101 because the claimed invention is directed to a product of nature (Camellia sinensis, lauramine oxide, decyl glucoside and Melaleuca alternifolia). The claims recite a composition containing Camellia sinensis leaf extract and/or Melaleuca alternifolia leaf oil, a glycolipid, an amphiphilic preservative lauramine oxide, a surfactant decyl glucoside and water for an anti-allergenic composition. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since claim 1 is drawn to a product of Camellia sinensis leaf extract and Melaleuca alternifolia leaf oil the claim is directed to a composition. Dependent claims further limit the combination composition glycolipids, surfactants and amphiphilic preservatives and are thus also directed to compositions from naturally occurring components. Claim 6 refers to a component lauramine oxide which is a naturally occurring compound and plant metabolite. Claims 11-14 refer to components such as decyl glucoside which is a natural, non-ionic surfactant.
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, which is a statutory category 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, he claims are product claims reciting something that appears to be a nature-based product (i.e., Camellia sinensis, lauramine oxide, decyl glucoside, and Melaleuca alternifolia leaf oil) 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 claim recites the naturally occurring components found within Camellia sinensis leaf extract, lauramine oxide, decyl glucoside and Melaleuca alternifolia leaf oil. 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 combination comprises branched chain fatty acids, which are also found in nature. 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 1-24 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 2 B 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 there cited exceptions because there aren’t any other additional elements to consider, which does not add an inventive concept to the claims.
Thus, the claims 1-24 are not eligible subject matter under current 35 U.S.C. 101
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 1-25 are rejected under 35 U.S.C 103 as being unpatentable over Yu et al. (WO-2008134712-A2).
Claim 1 recites an anti-allergenic composition comprising: (i) at least 0.01% w/w of a plant extract, wherein the plant extract is selected from the group consisting of Camellia sinensis leaf extract, Malaleuca alternifolia leaf oil, and mixtures thereof; (ii) a glycolipid; (iii) an amphiphilic preservative; and (iv) water. Claim 2 recites the anti-allergenic composition according to Claim 1, wherein the glycolipid is selected from the group consisting of sphingolipids, ceramides, glycerophospholipids, sphingolipid derivatives, and combinations thereof. Claim 3 recites the anti-allergenic composition according to Claim 2, wherein the glycolipid is a sphingolipid selected from the group consisting of sphingosine, sphinganine, phytosphingosine, a phytosphingosine salt, tetraacetyl-phytosphingosine, N-acetylphytosphingosine, and mixtures thereof. Claim 4 recites the anti-allergenic composition according to Claim 3, wherein the sphingolipid is in the range of 0.1% to 0.3% w/w. Claim 5 recites the anti-allergenic composition according to Claim 1, wherein the amphiphilic preservative is present in the range of 0.01% to 5% w/w. Claim 6 recites the anti-allergenic composition according to Claim 1, wherein the amphiphilic preservative is selected from the group consisting of lauramine oxide, myristamine oxide, a combination of lauramine oxide and myristamine oxide, N,N-dialkyl amine oxide with long alkyl chain between C10-C18, and mixtures thereof. Claim 7 recites the anti-allergenic composition according to Claim 1, further comprising at least one polyol. Claim 8 the anti-allergenic composition according to Claim 7, wherein the polyol has 2-12 carbon atoms. Claim 9 recites the anti-allergenic composition according to Claim 8, wherein the polyol is a 1,2-diol selected from the group consisting of 1,2-hexanediol, 1,2-octanediol, 1,2-decanediol, and mixtures thereof. Claim 10 recites the anti-allergenic composition according to Claim 9, wherein the polyol is present in the range of 0.01% to 5% w/w. Claim 11 recites the anti-allergenic composition according to Claim 1, further comprising one or more surfactants. Claim 12 recites the anti-allergenic composition according to Claim 11, wherein the one or more surfactants are present in the range of 0.1 to 20% w/w. Claim 13 recites the anti-allergenic composition according to Claim 11, wherein the one or more surfactants comprise decyl glucoside and polysorbate 20. Claim 14 recites anti-allergenic composition according to Claim 11, wherein a first surfactant has an HLB value between 10 and 18. Claim 15 recites the anti-allergenic composition according to Claim 14, wherein a second surfactant has an HLB value between 10 and 18 or between 5 and 10. Claim 16 recites the anti-allergenic composition according to Claim 1, further comprising a foam stabilizer. Claim 17 recites the anti-allergenic composition according to Claim 16, wherein the foam stabilizer is a polyethylene glycol diester of methyl glucose and a fatty acid. Claim 18 recites the anti-allergenic composition according to Claim 1, wherein the pH is in the range of 3.5 to 6.5. Claim 19 recites the anti-allergenic composition according to Claim 1, wherein the refractive index is about 1.33 to 1.35. Claim 20 recites the anti-allergenic composition according to Claim 1, wherein the specific gravity is about 0.99 to 1.01. Claim 21 recites the anti-allergenic composition according to Claim 1, further comprising one or more moisturizers, emollients, humectants, and lubricants. Claim 22 recites the anti-allergenic composition according to Claim 1, further comprising one or more skin conditioning agents, antioxidants, soothing agents, cooling agents, viscosity modifiers, and nutrients. Claim 23 recites the anti-allergenic composition according to Claim 1, wherein the composition is combined with a substrate capable of being impregnated with a desired amount of the composition. Claim 24 recites the anti-allergenic composition and substrate according to Claim 23, wherein the composition-impregnated substrate is configured as a single use product. Claim 25 recites an anti-allergenic composition consisting of: 0.1-0.3% phytosphingosine HCl, 0.01-5% hexanediol, 0.01-5% octanediol, 0.1-20% polysorbate 20, 0.1-20% decyl glucoside, at least 0.01% tea tree oil, at least 0.01% green tea extract, 0.01-5% lauramine oxide, and water q.s. to 100%.
The applicant is reminded that when reading the preamble in the context of the entire claim, the recitation "anti-allergenic" (claims 1-25) is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claims is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Yu et al. teaches a composition comprising an MMP inhibitor and a cosmetically suitable vehicle or pharmaceutically acceptable excipient (Abstract). Yu et al. teaches the following ingredients in the composition.
Preservatives/Antioxidants/Chelating Agents – see Yu et al. paragraph [0096]
In regards to Claim 1, Yu et al. discloses Camellia sinensis leaf oil, Melaleuca alternifolia (Tea Tree) leaf oil, the inventive composition may include 0% to approximately 4% by weight of the preservative, antioxidant, or chelating agent.
Plant Extracts - see paragraph [00101]
In Regards to claims 1 and 25, Yu et al. discloses the inventive cosmetic compositions may include an extract from a plant, plant extract may be added to the inventive composition to nourish the skin. Exemplary plants can include tea tree (green tea). The plant extract is used in an amount ranging from 0.01 to 1.0% by weight of the total composition, calculated as a residue obtained after distillation of extraction solvent therefrom. It is within the knowledge of one of skill in the art to add water, in varying amounts, to dilute active ingredients of a composition for administration into a living subject, an example of this use of water appears disclosed by Yu et al. in Example 9 (paragraph [00171]). Furthermore, water is listed among the exemplary solvents in Yu et al. paragraph [00113].
Salts
In Regards to claims 1-4, Yu et al. discloses various salts may be added to the inventive compositions, the salt used in the inventive compositions may be inorganic salt or an organic salt. Exemplary salts include phytosphingosine HCl (see paragraph [00114]). Typically, the concentration of the salt in the final composition is in the range of about 0.5% to about 5%. While 0.5% w/w is a higher concentration at this present invention, one of ordinary skill would know to stay within the ranges of 0.1-0.5% w/w as these ranges provide the most effective to the skin’s natural lipid barrier and at higher ranges such as between 0.3-0.5, offer more robust antimicrobial and anti-inflammatory action. (see paragraph [00115])
Surfactants/ Detergents/ Emulsifiers
In regards to claims 1, 5, 6, 11-15, and 25 it is within the knowledge of one of skill in the art to include at least one surfactant in the instantly claimed composition to blend the oil and water fractions (instant claim 1) through emulsification of the oil fraction (solubilising the oil, in the broad sense of the word solubilising). Yu et al. discloses surfactants that may be used in the cosmetic compositions. Yu et al. explicitly discloses polysorbate 20 as a solubilizer for certain MMP inhibitors (paragraph [0086]). The composition contains a surfactant in the range from about 0.01 to about 20% by weight (see paragraph [00113]).
In paragraph [00114], Yu et al. discloses various mixtures of coco glucoside with salts: disodium coco-glucoside citrate, disodium coco-glucoside sulfosuccinate, and sodium coco-glucoside tartrate, and in paragraph [00115] recites a range of about 1% to about 20% by weight for the concentration of salt in the final composition. One of skill in the art could have substituted coco-glucoside/coco glucoside with decyl glucoside in any of these mixtures with the predictable effect of a mixture containing a glucoside with surfactant properties like coco-glucoside, but more soluble in water because of the shorter aliphatic chain (12-carbon chain for coco glucoside vs 10-carbon chain for decyl glucoside). Although Yu et al. does not recite an intended use for coco-glucoside as a surfactant, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
While Yu et al. does not expressly recite the HLB value of either surfactant, the HLB value of each surfactant is considered an inherent property of the surfactant; therefore, the HLB values recited in claims 14 and 15 are obvious over the obvious use of the surfactants having those HLB values. The applicant has specified that “The HLB values of decyl glucoside and polysorbate 20 are 12.8 and 16.7, respectively” between 10 and 18 (claims 14 and 15); therefore, the limitations of claims 14 and 15 are met over the obviousness of including decyl glucoside and polysorbate over Yu et al. and knowledge of one of skill in the art.
Yu et al. explicitly discloses lauramine oxide under Fragrances/Perfumes (paragraph [00103]), where Yu et al. recites “Fragrance ingredient, as defined by the International Fragrance Association, is "any basic substance used in the manufacture of fragrance materials for its odorous, odor- enhancing, or blending properties’” ; therefore, lauramine oxide is reasonably a surfactant that blends certain odorous substances into the composition. Yu et al. specifies “The perfume or fragrance may be used in the cosmetic composition in an amount ranging from 0.0001% to 10% by weight” (paragraph [00103]). Although Yu et al. does not recite an intended use for lauramine oxide as a preservative, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (instant claims 1, 5, and 6). Furthermore, one of skill in the art would be motivated to include lauramine oxide in the instantly claimed invention to emulsify the oil fraction in the aqueous solvent as recited above. One of skill in the art would have a reasonable expectation of success at using lauramine oxide to emulsify plant oils such as Melaleuca alternifolia leaf oil in an aqueous solvent because of its surfactant property, having a polar head group and aliphatic hydrophobic tail.
Solvent
In regards to claims 7-10 and 25 Yu et al. discloses the inventive cosmetic compositions typically include a solvent or combination of solvents to dissolve or solubilize the components of the composition. Exemplary solvents include 1,2-hexanediol and ethyl hexanediol (octane-3,3-diol), the solvent may make up from about 1% to about 99% by weight of the composition (see paragraph [00113]).
Thickeners/Viscosity Modifiers
In regards to claims 16, 17, and 22, Yu et al. discloses the inventive cosmetic compositions may include a thickening agent or a viscosity modifier. The thickening agent may be a natural or synthetic thickening agent. Examples of thickeners include PEG-120 Methyl Glucose Trioleate. This is a polyethylene glycol diester derivative of methyl glucose and a fatty acid (see paragraph [00105]).
Humectants
In regards to claim 21, Yu et al. further teaches the inventive cosmetic composition may include a humectant. Humectants are typically found in cosmetic compositions to reduce static and/or provide a moisturizing quality to the composition. Examples of humectants include diglyceryl or hyaluronic acid (see paragraph [00102]).
Further teachings of Yu et al.
Yu et al. explicitly teaches a “patch” as a form of administering the MMP inhibitor to the skin, implying a substrate impregnated with liquid components of the composition and applied to the skin: “The MMP inhibitor may be administered to the skin in the form of a cream, lotion, ointment, powder, spray, solution, gel, paste, serum, stick, foam, patch, face masks, etc.” (paragraph [0012]; instant claim 23). It is also within the knowledge of one of skill in the art to use a substrate impregnated with a liquid composition to control the application of the liquid on the skin, for example, using a cotton ball impregnated with a liquid cosmetic composition to spread the composition over the skin (instant claim 23). One of skill in the art would have been motivated to configure an impregnatable substrate for single-use dermal application, to avoid reintroducing onto the skin oils, bacteria, and/or fungi that have been absorbed by the impregnated substrate. One of skill in the art would have had a reasonable expectation of success at configuring the impregnated substrate as a single use product (instant claim 24), by impregnating a disposable material made of cotton or cellulose with the instantly claimed composition as recited in claims 1-22 and 25.
Yu et al. also does not expressly recite the exact given w/w ranges as the claimed invention, however, the ranges as provided in the art do overlap with the ranges of the claimed invention and would be deemed prima facie obvious as determined by MPEP §2144.05:
I. OVERLAPPING, APPROACHING, AND SIMILAR RANGES, AMOUNTS, AND PROPORTIONS
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range).
Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205-206 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); In re Becket, 88 F.2d 684 (CCPA 1937) ("Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys."); In re Dreyfus, 73 F.2d 931, 934, 24 USPQ 52, 55 (CCPA 1934)(the prior art, which taught about 0.7:1 of alkali to water, renders unpatentable a claim that increased the proportion to at least 1:1 because there was no showing that the claimed proportions were critical); In re Lilienfeld, 67 F.2d 920, 924, 20 USPQ 53, 57 (CCPA 1933)(the prior art teaching an alkali cellulose containing minimal amounts of water, found by the Examiner to be in the 5-8% range, the claims sought to be patented were to an alkali cellulose with varying higher ranges of water (e.g., "not substantially less than 13%," "not substantially below 17%," and "between about 13[%] and 20%"); K-Swiss Inc. v. Glide N Lock GmbH, 567 Fed. App'x 906 (Fed. Cir. 2014)(reversing the Board's decision, in an appeal of an inter partes reexamination proceeding, that certain claims were not prima facie obvious due to non-overlapping ranges); In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018)(the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of "less than 6 pounds per cubic feet" and the prior art range of "between 6 lbs./ft3 and 25 lbs./ft3" were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.).
"[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005) (claimed alloy held obvious over prior art alloy that taught ranges of weight percentages overlapping, and in most instances completely encompassing, claimed ranges; furthermore, narrower ranges taught by reference overlapped all but one range in claimed invention). However, if the reference’s disclosed range is so broad as to encompass a very large number of possible distinct compositions, this might present a situation analogous to the obviousness of a species when the prior art broadly discloses a genus. Id. See also In re Baird, 16 F.3d 380, 383, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994) ("[a] disclosure of millions of compounds does not render obvious a claim to three compounds, particularly when that disclosure indicates a preference leading away from the claimed compounds."); MPEP § 2144.08; and subsection III.D below for an additional discussion on consideration of prior art disclosures of a broad range.
A range can be disclosed in multiple prior art references instead of in a single prior art reference depending on the specific facts of the case. Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322, 73 USPQ2d 1225, 1228 (Fed. Cir. 2004). The patent claim at issue was directed to a weight plate having 3 elongated openings that served as handles for transporting the weight plate. Multiple prior art patents each disclosed weight plates having 1, 2 or 4 elongated openings. 392 F.3d at 1319, 73 USPQ2d at 1226. The court stated that the claimed weight plate having 3 elongated openings fell within the "range" of the prior art and was thus presumed obvious. 392 F.3d at 1322, 73 USPQ2d at 1228. The court further stated that the "range" disclosed in multiple prior art patents is "a distinction without a difference" from previous range cases which involved a range disclosed in a single patent since the "prior art suggested that a larger number of elongated grips in the weight plates was beneficial… thus plainly suggesting that one skilled in the art look to the range appearing in the prior art." Id.
Routine Optimization of Ranges
Instant claims 18-20 are distinguished from the cited prior art in reciting the following properties of the instantly claimed composition:
A pH in the range of 3.5 to 6.5 (claim 18)
A refractive index of about 1.33 to 1.35 (claim 19)
A specific gravity of about 0.99 to 1.01 (claim 20)
However, these claim limitations are obvious to one of skill in the art over routine optimization. One of skill in the art could adjust pH through the addition of strong acids and/or bases to the composition, and could have varied the water content of the composition to adjust the specific gravity and refractive index . One of skill in the art could use a pH probe to measure pH, a refractometer to measure refractive index, and an analytical balance and volumetric glassware to measure mass and volume, respectively, to calculate specific gravity. Furthermore, it is not clear that these ranges recited in claims 18-20 are unexpected from the teachings of the prior art.
Yu et al. is 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 ingredients of the instantly claimed composition, 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 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 Yu et al., the invention as a whole, drawn to a composition as described in claims 1-25, 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
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