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 with traverse of Group I, claims 1-19 in the reply filed on October 14, 2025 is acknowledged. The traversal is on the grounds that the basis for finding lack of unity of invention differs from the cited art of Krumhar and Singh. Applicant’s state the present claims relate to novel emulgel compositions and Krumhar is drawn to oral administration. Applicant’s state the composition of Krumhar does not disclose methyls salicylate, menthol. Applicant’s state the compositions disclosed in Krumhar and Singh differ from the present application. . Applicant’s arguments have been fully considered; however, they are not found persuasive as indicated in the restriction requirement that was mailed on August 18, 2025. The claims lack unity of invention because the prior art references do disclose the effective amount of the compositions for treatment of arthritis and therefore the claimed invention does not make a contribution over the prior art.
The restriction requirement is still deemed proper and is therefore made FINAL.
Claim 24 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on October 14, 2025.
Claim Status:
Claims 3, 9, and 18 are amended.
Claims 20-23 are cancelled.
Claim 24 is withdrawn.
Claims 1-19 are pending and under examination.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application, filed on August 11, 2023. The priority date of Application No. PCT/IB2022/051406 is February 17, 2022, and IN2024141006775 is February 18, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 24, 2024 is being considered by the examiner. The signed IDS forms are attached with the instant office action.
Claim Rejections - 35 USC § 112 (Second Paragraph)
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.
Claim 3 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.
In claim 3, it is unclear what the phrase “augmented absorption technology” encompasses. What does augmented mean in the context? The phrase absorption technology is broad and encompasses multiple possible interpretation. It is unclear how the augmented absorption technology has been used in the scope of the claim. Clarification is requested.
Claims 6-13 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 6-13 recites the broad recitation of the phrase “and combination thereof”, and the claim 6 recites “preservative is”, claim 7 recites “gelling agent is”, claim 8 recites “chelating agent is”, claim 9 recites “wetting agent is”, claim 10 recites “antioxidant is”, claim 11 recites “emulsifier is”, claim 12 recites “stabilizer is”, and claim 13 recites “emollient is”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The resulting claims do not clearly set forth the metes and bounds of the patent protection desired and one would not reasonably be apprised of the claimed scope. Thus, the claim language is indefinite. Correction is required. A suggestion to overcome this indefinite scope is to eliminate the word “and combination thereof” and place “or a combination thereof”. Also, the word in claims the claim 6 recites “preservative is”, claim 7 recites “gelling agent is”, claim 8 recites “chelating agent is”, claim 9 recites “wetting agent is”, claim 10 recites “antioxidant is”, claim 11 recites “emulsifier is”, claim 12 recites “stabilizer is”, and claim 13 recites “emollient is”, eliminate the word “is” and place “contain one or more of”.
Regarding claim 7, the phrase " carbomer like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. What is encompassed by carbomer? Clarification is requested. See MPEP § 2173.05(d).
In addition, in claim 7, what are the modification to the carrageenan? The metes and bound are unclear as to the structural alterations.
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
Claim Rejections - 35 USC § 112 (First Paragraph)
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 7 and 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In instant case claim 7, recites the phrase “and derivatives thereof”.
The MPEP states that the purpose of the written description requirement is to ensure that the invention had possession, as of the filing date of the application, of the specific subject matter later claimed by him or her. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention.’ Lockwood v. American Airlines, Inc., 107 F. 3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F. 2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, no that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F. 3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient” MPEP § 2163.
Level of Skill and Knowledge in the Art:
The MPEP indicates:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
What constitutes a “representative number” is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a “representative number” depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly.
The specification does not clearly teach a specific meaning for what derivatives thereof. A number of examples are provided but are incomplete as to how to make and use the invention.
Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116).
There is no known means for derivatives thereof, besides the derivatives specifically described in the instant disclosure, with regard to claim 7 [e.g., gelling agent], and claim 9 [e.g. wetting agent]. The skilled artisan could not even relatively predict what other gelling agents and wetting agents and the derivatives can be used for the composition. Absent any discussion regarding correlation between structure and function, even the most skilled of artisans would need to guess what other extracts could potentially have the effect(s) listed in the claim(s).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a composition to prepare a product of nature without significantly more, and a product of nature (e.g. Curcumin, Boswellia serrata, Methyl salicylate and Menthol as active ingredients and pharmaceutically acceptable excipients, and Ginger, Glucosamine sulphate, Chondroitin sulphate). The pharmaceutically acceptable excipients can be a liquid such as water, and composition comprising water is considered natural product. The claim(s) recite(s) a composition of arthritis emulgel comprising Curcumin, Boswellia serrata, Methyl salicylate and Menthol as active ingredients and pharmaceutically acceptable excipients, and claim 4 recites the composition optionally contains one or more of Ginger, Glucosamine sulphate, Chondroitin sulphate and combination thereof. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since claim 1 and 4 are directed to a composition of arthritis emulgel comprising Curcumin, Boswellia serrata, Methyl salicylate and Menthol as active ingredients and pharmaceutically acceptable excipients, and Ginger, Glucosamine sulphate, Chondroitin sulphate, the claims are directed to a composition of matter.
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".
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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.
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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.
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Nature-based Product Claim Analysis
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Where the claim is to a nature-based product by itself, the markedly different characteristics analysis should be applied to the entire product.
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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.
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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.
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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.
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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 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., Curcumin, Boswellia serrata, Methyl salicylate and Menthol as active ingredients and pharmaceutically acceptable excipients (this can be a liquid such as water)), and Ginger, Glucosamine sulphate, Chondroitin sulphate 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 Curcumin, Boswellia serrata, Methyl salicylate and Menthol as active ingredients and pharmaceutically acceptable excipients, and Ginger, Glucosamine sulphate, Chondroitin sulphate. This equates to a natural plant. The closest naturally occurring counterparts of components are those same components when found existing in the plant, even when purified and/or concentrated because they are chemically identical 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 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 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 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 standards.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vad Vijay et. al. (WO-2011044381-A1).
In instant case, claim 1 recites, novel composition of arthritis emulgel comprising Curcumin, Boswellia serrata, Methyl salicylate and Menthol as active ingredients and pharmaceutically acceptable excipients. Vad et. al. ‘381 teaches, “composition for the relief of pain, a composition includes creams, gels, etc…(abstract);” “anti-inflammatory agent will be present as part of the oil, although they may also be part of the cream base or in the cream base alone. Exemplary anti-inflammatory agents include, Boswella, for example Boswella serrata, or an extract thereof, curcumin, for example white curcumin, wintergreen or wintergreen oil (Methyl salicylate as in instant claim 1), and Menthol, is an exemplary component used in the present formulation as a cooling component for soothing pain relief and as a signal of efficacy ([Detailed Description of Invention [para. 0035])”; As recited in claim 1, the pharmaceutically acceptable excipients, Vad et. al. ‘381 teaches “Compositions according to the invention can include additional components to provide additional physically beneficial effects, as well as for other purposes. Exemplary embodiments of the composition include muscle membrane stabilizers, any solubilizing solvent that provides a stable oil is acceptable, and include preservatives (Detailed Description of Invention [para. 0054]).” Thus, the reference anticipates a pain relief composition comprising elements present in instant claim 1.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir.1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
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 1-2, and 4-19 are rejected under 35 U.S.C. 103 as being unpatentable over Vad Vijay et. al. (WO-2011044381-A1) and further in view of Mayo, John Charles et. al. (US-20120220669-A1) and Morde Abhijeet et. al. (WO-2021090154-A1).
In instant case, claims 1-19 are drawn to novel composition of arthritis emulgel comprising Curcumin, Boswellia serrata, Methyl salicylate and Menthol as active ingredients and pharmaceutically acceptable excipients, wherein said arthritis emulgel comprising:(a) 3% to 10% (w/w) of Curcumin, Boswellia serrata, Methyl salicylate and Menthol as active ingredients,(b) 2% to 8% (w/w) of skin permeation enhancer,(c) 0.5% to 3% (w/w) of preservative, (d) 0.5% to 5% (w/w) of gelling agent,(e) 0.01% to 1% (w/w) of chelating agent,(f) 1% to 5% (w/w) of wetting agent,(g) 0.01% to 1% (w/w) of antioxidants,(h) 0.5% to 5% (w/w) of emulsifier,(i) 1% to 5% (w/w) of stabilizer, and optionally (j) 0.5% to 3% (w/w) of emollient. Vad et. al. ‘381 teaches, composition for the relief of pain, a composition includes creams, gels, etc…(abstract); “anti-inflammatory agent will be present as part of the oil, although they may also be part of the cream base or in the cream base alone. Exemplary anti-inflammatory agents include, Boswella, for example Boswella serrata, or an extract thereof, curcumin, for example white curcumin, ginger or an extract thereof (as in instant claim 4), wintergreen or wintergreen oil (Methyl salicylate as in instant claim 1 and 2a, 14-17a), anti-inflammatory agents can be present from about 0.001 to about 10% ([Detailed Description of Invention [para. 0028-0029]), and Menthol, is an exemplary component used in the present formulation as a cooling component for soothing pain relief and as a signal of efficacy, the cooling agent can be present in an amount from about 0.0001% to about 15% ([Detailed Description of Invention [para. 0035-0036]).” “The transducer is used to enhance skin permeation, can be present from about 0.001% to about 40% (Detailed Description of Invention [para. 0042-0043]) (as in instant claim 2b)”; “the composition can be prepared in the form of a gel. Gels can be prepared by addition of a gelling agent (Detailed Description of Invention [para. 0058]) (as in instant claim 2d, 7 and 14-17d).”
Furthermore, Vad et. al ‘381 teaches, “emulsifying agents include cetostearyl alcohol and triethanolamine (TEA), as emulsifying agents, surfactants and the like that stabilize emulsions (as in instant claim 2h and 2i, and 14h and 14i – 17h and 17i, 11-12, and 19) (Detailed Description [para. 0052]).”; “Exemplary active and inactive ingredients useful in the invention thus include, propylene glycol (Detailed Description of the Invention [para. 0057]) (as in instant claims 2j as emollient, claim13, 14k, and 16k).” Vad et. al. teachings, provide pain relief composition which can be made in gel, and most components taught by the reference are present as in instant claim.
In instant case claim 4 recites, the composition optionally contains one or more of Ginger, Glucosamine sulphate, Chondroitin sulphate and combination thereof. Vad et. al. ‘381 teaches, “the present invention can further include a joint or muscle soothing component that can also have anti-inflammatory effects. An exemplary joint or muscle soothing anti-inflammatory complex includes glucosamine (for example as sulfate), ginger root extract, chondroitin.” “Other non-active (i.e. non-active with respect to pain relief activity) ingredients can include, preservatives and antioxidants such as, for example, disodium EDTA…, parabens, for example propyl paraben, methyl parabens, etc., and pH adjustors such as, for example, citric acid (Summary of Invention [para. 0055]),” (as in instant claim 6).
Although Vad et.al. ‘381 does not explicitly teach, chelating agent such as EDTA sodium, antioxidant such as butylated hydroxytoluene (BHT), and butylated hydroxyanisole (BHA), however, Mayo et. al. ‘669 teaches, “Examples of "antioxidants" are butylated hydroxy anisol (BHA), butylated hydroxytoluene (BHT) (as in instant claims 2g, 10, and 14-17(g), (Detailed Description of the Invention [para. 0073]; and antioxidants, emollients, chelator (phosphatidyl choline), (Examples [para. 0099] Table 8 (as in instant claim 2e, 8, and 14-17b).
Furthermore, Mayo et. al. ‘669 teaches “the invention provides a formulation that comprises a lysophospholipid, a second phospholipid, such as phosphatidylcholine, and a nonionic surfactant (Summary of Invention [para. 0009]), (as in instant claims 5, and 14-17b). Regarding claim 2f, 9, and 14-17f, the wetting agents is referred to as surfactant in the art and Mayo et. al. ‘669 teaches, ”list of relevant surfactants and surfactant…, castor oil (Summary of Invention [para. 0059-0060]) as recited in instant case.” Regarding claim 2c, which recites preservative, and claims 14-17c recites benzyl alcohol, Mayo et. al. ‘669 teaches, “antimicrobial" agent is commonly added to reduce the bacterial count in pharmaceutical formulations. Some examples of microbicides are benzyl alcohol (Summary of Invention [para. 0072]).” Regarding claim 19, the gelling agent Mayo et. al. ‘669 teaches, “Thickeners" are used selected from, hydroxypropylmethyl- or methyl-cellulose (Detailed Description of Invnetion [para.0074])”.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the components from Vad et. al and Mayo et. al. into the composition of instant application because both references teach the components comprising elements listed in instant case and achieve a success for arthiritis emulgel composition. Since both of the references teach composition for arthritis and pain, one of the ordinary skills in the art would have been motivated to combine the teachings of the references together.
Additionally, Vad et. al. and Mayo et. al does not explicitly teach gelling agent as recited in claim 7, ethanol as recited in claims 14-17j, however, Morde et. al. ‘154, teaches “the solvent in preparation of the integrated active composition is ethanol, and the hydrophilic carrier employed in preparation of the integrated active composition is, polyethylene glycols, and plant polysaccharides (Detailed Description of the Invention [para.0017- 0018]),”
It would also have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the components recited by Vad et. al, Mayo et. al, and Morde et.al, because all the references teach a composition comprising elements recited in instant application. One of ordinally skilled in the art would be motivated to produce arthritis emulgel by combining the teachings of the references. Determining an appropriate amount of components to be used within the composition is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
It is prima facie obvious to combine the compositions each of which are taught by the prior art to be useful for the same purpose to provide a composition arthritis emulgel comprising Curcumin, Boswellia serrata, Methyl salicylate and Menthol as active ingredients and pharmaceutically acceptable excipients, and skin permeation enhancer, preservative, gelling agent, chelating agent, wetting agent, antioxidants, emulsifier, stabilizer, and optionally emollient, for in order to form another composition to be used for the very same purpose.... [T]he idea of combining the teachings from the references, flows logically from there having been individually taught in the prior art.
“In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).”
Further, for the composition of arthiritis emulgel, the components skin permeation enhancer, preservative, gelling agent, chelating agent, antioxidants, emulsifier, stabilizer, and emollient, which would have been routinely determined and optimized in the pharmaceutical art. Because of their properties for gels, creams or any type of liquid formulation for joint and muscle pain relief.
One would have had a reasonable expectation of success to achieve to provide a composition for arthritis emulgel comprising Curcumin, Boswellia serrata, Methyl salicylate and Menthol as active ingredients and pharmaceutically acceptable excipients, and skin permeation enhancer, preservative, gelling agent, chelating agent, wetting agent, antioxidants, emulsifier, stabilizer, and optionally emollient, because the cited references teach providing the composition in a similar manner, and because, success merely requires preparing the composition thereof, especially in the absence of the criticality of some undisclosed features, or unexpected results.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was effectively filled. As evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are presently allowed.
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/ALPA NILESH AMIN/Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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