DETAILED ACTION
The receipt is acknowledged of applicant’s election filed 10/27/2025; and IDS filed 03/06/2023.
Claims 1-19 are pending.
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 of the following species: topical administration; topical formulation comprising emulsion, lotion, dispersion, ointment, gel, tincture, and powder; and skin condition to be treated, claims 1-4, 6-8, 11-18, in the reply filed on 10/27/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Note, claims 5 and 19 are directed to transdermal formulations, and not the elected topical formulations.
Claims 5, 9, 10 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/27/2025.
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 1-4, 6-8, and 11-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
First, the claimed invention must be to one of the four statutory categories. 35 U.S.C. 101 defines the four categories of invention that Congress deemed to be the appropriate subject matter of a patent: processes, machines, manufactures and compositions of matter. The latter three categories define "things" or "products" while the first category defines "actions" (i.e., inventions that consist of a series of steps or acts to be performed). See 35 U.S.C. 100(b) ("The term ‘process’ means process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material."). See MPEP § 2106.03 for detailed information on the four categories.
Second, the claimed invention also must qualify as patent-eligible subject matter, i.e., the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception. The judicial exceptions (also called "judicially recognized exceptions" or simply "exceptions") are subject matter that the courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013). See MPEP § 2106.04 for detailed information on the judicial exceptions.
The claims do not include additional elements that are sufficient to amount
to significantly more than the judicial exception because instant claim 1-4, 6-8, 11-18 are directed to a composition containing one or more alkaloids of Mitragyna speciosa and one or more cannabinoids of cannabis indica or cannabis sativa, and nominal method of using the composition without any specific steps.
Analysis of the flowchart:
Step 1, is the claim to a process, machine, manufacture or composition of matter?
Yes. The claim is drawn to a composition of matter and method of its use without reciting any steps.
Step 2A. Prong one: Is the claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea?
Yes, the claims are drawn to a product of nature, one or more alkaloids of Mitragyna speciosa and one or more cannabinoids of cannabis indica or cannabis sativa. There is no indication that the plants have any characteristics that are different from the naturally occurring components in alkaloids of Mitragyna speciosa and in cannabinoids of cannabis indica or cannabis sativa.
Step 2A. Prong two: Does the claims recite additional elements that amount to significantly more than the judicial exception?
No. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception, as there is no indication that alkaloids of Mitragyna speciosa and cannabinoids of cannabis indica or cannabis sativa have been altered by any way, other than extraction, that caused active components of extracted plants to have any characteristics that are different from the naturally occurring components.
Step 2B. If additional elements of the claim provide an inventive concept (Step 2B) (also called "significantly more" than the recited judicial exception).
No, in the instant case no additional elements are added to the plants, even extraction and addition of excipients do no alter the nature of the plants or their ingredients in the extracts. The claims read on mixing the plants with water and rubbing them to the skin, which read on extracted plant mixed with excipient, forming composition applied to the skin. The composition of claim 1 uses a mixture of two plants. Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 US 127, 131 (1948). As in Funk Brothers, Applicants did not create or alter the natural components in the composition, but simply put them together. These components existed in nature before used by applicant. At best, Applicants' contribution was recognizing that these natural products may have clinical uses in certain patient populations. Applicant does not contend there are any changes to the used elements that result from the combination of elements of claim 1. The claims recite natural components put together, and the claimed natural components are altered less than the isolated nucleic acid in Myriad, where chemical bonds were severed to release the nucleic acid from the chromosome, see Myriad, 133 S. Ct. at 2118. Unlike the nucleic acid in Myriad, the claimed components of the instant product are chemically unchanged. Applicants do not contend there are any chemical changes that result from forming the components into formulation as claimed by claims 1, 6, 11-14.
Claims 1, 2 and 15-18 recite certain amounts that cannot alter the nature of the alkaloids or cannabinoids from how they exist in nature. Even certain amounts of such ingredients present in the composition, the characteristics of the plants are not markedly altered from the ingredients in the plants present in nature.
Claim 3 recite purified extract, however, extraction and purification and isolation do not alter the nature of the ingredients of the plant from. There is no indication that any component or any manipulation of the claimed plants ingredients result in a different characteristic of the plants ingredients as compared to components of the extract that occur in the nature.
Claim 4 recites specific alkaloids of Mitragyna speciosa and specific cannabinoids of cannabis plant that are inherent component of the plants and are present in the composition as they exist in nature.
The formulations recites by claims 6 and 11, even the ingredients of the plants are included in topical formulation, the nature of the ingredients of plants are not altered. There is no indication that any component or any manipulation of the claimed plants result in a different characteristic of the plants as compared to components of the extract that occur in the nature.
Regarding method of using the composition of claim 1 comprising mixture of plants as claimed by claims 7, 8, 12 and 14, the method of using the composition does not alter the nature of the plants. There is no method step that alter nature of the plant ingredients. Therefore, the claimed method using the claimed plant extracts is not markedly different from their closest naturally occurring counterparts and thus are product of nature judicial exceptions. Rubbing wet plants to skin or scalp will read on the claims.
Therefore, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements beyond the claimed plants ingredients. Further, regarding the method claims, there are no claimed method steps, there are no additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception themselves. Therefore, the claims do not recite something significantly more than a judicial exception and are thus deemed patent ineligible subject matter.
Like Funk Brothers, and unlike Diamond v. Chakrabarty, 447 U.S. 303 (1980), the claimed elements of the instant composition were not a "product of human ingenuity" with a "distinctive character", Diamond, 447 U.S. at 31 O, but rather an "aggregation of select" components from nature, unchanged individually in their chemical nature and not alleged to acquire new properties by their formulation or inclusion in any formulation, see Funk Brothers, 333 U.S. at 131. In other words, there is nothing markedly different between Ginseng saponin, Glycyrrhiza glabra extract, bifida ferment lysate and Centella asiatica used in the instant composition and their natural products. Supreme Court precedent constrains us to find that neither isolating natural products nor combining them together represents an act of invention unless the combination results in something "markedly different", and no such result has been demonstrated in the instant case. See Myriad, 133 S. Ct. at 2117; Funk Brothers, 333 U.S. at 132.
Principles of Law
"' [L]aws of nature, natural phenomena, and abstract ideas' are not patentable." Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S.Ct. 1289, 1293 (2012).
"Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention." Ass 'n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116-17 (2013).
Accordingly, the claimed composition recites something that appears to be a natural product that is not markedly different in structure from naturally occurring elements and hence reads on a patent ineligible subject matter under the above guidelines mentioned.
The Court has made clear that to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words "apply it." Essentially, appending conventional steps specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible.
Court’s decision rested upon an examination of the particular claims in light of the Court's precedents, specifically Bilski, Flook and Diehr. The Court repeated the long standing exceptions (laws of nature, natural phenomena, and abstract ideas) to categories of patent eligibility defined in 35 U .S.C. § 101. In conducting the analysis, the Court addressed the "machine-or-transformation" test explained in Bilski with a reminder that the test is an "important and useful clue" to patentability but that it does not trump the "law of nature" exclusion. A claim that recites a law of nature or natural correlation, with additional steps that involve well-understood, routine, conventional activity previously engaged in by researchers in the field is not patent-eligible, regardless of whether the steps result in a transformation. On the other hand, reaching back to Neilson, the Court pointed to an eligible process that included not only a law of nature (hot air promotes ignition) but also several unconventional steps (involving a blast furnace) that confined the claims to a particular, useful application of the principle.
Claim Rejections - 35 USC § 112(a)
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.
Claims 7-8, 11-12 are 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 skin disorder, does not reasonably provide enablement for preventing skin disorder before it even happens. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to: (a) the nature of the invention; (b) the breadth of the claims; (c) the state of the prior art; (d) the amount of direction provided by the inventor; (e) the existence of working examples; (f) the relative skill of those in the art; (g) whether the quantity of experimentation needed to make or use the invention based on the content of the disclosure is "undue"; and (h) the level of predictability in the art (MPEP 2164.01 (a)).
Nature of the invention and Breadth of the claims: The claims are directed to a method of preventing and/or treating skin disorders and/or conditions, comprising the step of using the preparation comprising one or more alkaloids of Mitragyna speciosa and one or more cannabinoids of Cannabis indica or Cannabis sativa. The enabling disclosure must teach the skilled artisan how to use the claimed composition to prevent all claimed skin disorders. Further, it is well established that, the enabling specification must teach those skilled in the art to make and use the full scope of the claimed invention without undue experimentation. “Although not explicitly stated in section 112, to be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without "undue experimentation." Vaeck, 947 F.2d at 495, 20 USPQ2d at 1444; Wands, 858 F.2d at 736-37, 8 USPQ2d at 1404; In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (the first paragraph of section 112 requires that the scope of protection sought in a claim bear a reasonable correlation to the scope of enablement provided by the specification).” In re Wright (CAFC) 27 USPQ2d 1510 at 1513.
With regard to scope, Applicant is purporting treatment and prevention of all skin conditions as claimed by claim 7. However, only treatment and not prevention of skin conditions by administering the claimed composition is provided, not even their cure. The claim encompasses prevention of disorders that may have potential causes other than those disclosed in the specification. This may or may not be addressed by the administration of the claimed composition. Moreover, the specification is directed to treating skin conditions by the instant composition. The claims encompass prevention of all skin conditions including conditions in susceptible patients, and the burden of enabling prevention of conditions would be greater than that of enabling a treatment due to the need of additional testing and screening to those humans and dogs susceptible to conditions that may or may not happen. Prevention of skin conditions may not be addressed by the administration of the instantly claimed composition.
Amount of direction provided by the inventor and existence of working examples: At the outset, it is noted that the instant disclosure does not provide a working example wherein any disorder within the scope of the claims actually prevented. Although, the specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970), lack of a working example is a factor to be considered, especially in a case involving an unpredictable and undeveloped art. Topical treatment of skin conditions are generally viewed as unpredictable and achieving a useful therapeutic outcome in preventing skin disorders is highly unpredictable. Thus, the relevant question in light of the failure of the application to provide a working example is whether the manner and process of preventing skin disorders. For example, skin cancer may require radiotherapy or chemotherapy after it happens but not to be prevented by the instant composition. Skin trauma may require surgical interference after it happens, but cannot be prevented. Skin autoimmune diseases may require specific immunosuppressive drugs after diagnosis but not prevented before they happen. Therefore, the skilled artisan would be able to use the invention commensurate with the full scope of what is claimed in term of preventing skin disorders.
The instant disclosure describes and has enabled treating skin conditions with the claimed composition. The specification provides only speculation regarding prevention. The specification provides no guidance, in the way written description, that any skin condition is prevented. This is because it is not obvious from the disclosure of treating a disorder with a composition if the same composition will work in preventing occurrence of the disorder. A disclosure should contain representative examples, which provide reasonable assurance to one skilled in the art that the compositions fall within the scope of a claim will possess the alleged activity. See In re Riat et al. (CCPA 1964) 327 F2d 685, 140 USPQ 471 ; In re Barr et al. (CCPA 1971) 444 F 2d 349, 151 USPQ 724.
Thus, with regard to preventing skin disorders, the application appears to assert a hypothetical possibility that the claimed composition can be used for prevention.
State of the prior art and level of predictability in the art: The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability.
Using the claimed plants extracts in treating skin disorders is recognized by the cited art, and it is predictable, not prevention of any condition see the art rejections below for Kariman and Changoer. (MPEP 2164.03.) In cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific laws. In cases involving unpredictable factors, such as pharmaceutical art involving plants, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved. In the instant case, at the time the instant application was filed the state of the art with regard to preventing skin conditions using plants was at an early stage of development and obtaining therapeutically effective outcomes by administering compositions such as the composition currently claimed was highly unpredictable. The unpredictability of the prevention of skin condition before it happens is very high. The lack of significant guidance from the specification or prior art with regard completely preventing of such condition with the administration of the instant composition makes practicing the claimed invention unpredictable in terms of the prevention.
Relative skill of those in the art and quantity of experimentation needed to make or use the invention: The relative level of skill possessed by one of ordinary skill in the art of treating topical skin conditions research is relatively high, as a majority of lead investigators directing scientific research and development in this particular technological area possess a Ph.D. or M.D. in a scientific discipline such medicinal chemistry, biochemistry, pharmacology, biology or the like.
Although the relative level of skill in the art is high, one of ordinary skill would not have been able to prevent the broad scope of skin conditions encompassed by the claims without undue experimentation. Given the highly unpredictable state of the art, the skilled artisan clearly would not be able to extend the teachings of the art and develop prevent the broad scope of skin conditions covered by the claims without extensive trial and error experimentation.
In fact, what is disclosed in the instant application with respect to preventing skin disorders amounts to no more that theoretical speculation in a highly unpredictable art. The law is clear that the first paragraph of 35 USC § 112 requires more that the disclosure of a theoretical possibility. “Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that ‘a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.’) Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.” Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, 1005. See also Rasmusson v. SmithKline Beecham Corp., 75 USPQ2d 1297 (Fed. Cir. 2005) (In response to Rasmusson’s argument that the enablement requirement of section 112 does not mandate a showing of utility or, if it does, it mandates only a showing that it is “not implausible” that the invention will work for its intended purpose, the Court states, “As we have explained, we have required a greater measure of proof, and for good reason. If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to ‘inventions’ consisting of little more than respectable guesses as to the likelihood of their success. When one of the guesses later proved true, the ‘inventor’ would be rewarded the spoils instead of the party who demonstrated that the method actually worked. That scenario is not consistent with the statutory requirement that the inventor enable an invention rather than merely proposing an unproved hypothesis.”)
The art and the specification demonstrated treating skin conditions. Since the prevention of a disorder before it happens cannot be predicted, but must be determined in each individual from case to case by experimental study, and when the above factors are weighed together, one of ordinary skill in the art would be burdened with undue experimentation to determine susceptible patients and to make/use the instant compositions for preventing skin conditions, whether responsive to the claimed plants extracts, is entirely prevented without guidance from the specification or the prior art. One of ordinary skill in the art would have to conduct time-consuming and costly experimental methods comprising functional and non-functional assays representing both in vitro and in vivo experiments to determine which "skin condition" of "a patient" will be effectively treated or prevented by the instantly claimed method. Therefore, undue experimentation becomes the burden of the practitioner.
In view of the broad scope of the claims, the nascent and unpredictable state of the art and the failure of the application to teach one of skill in the art how to make and use the claimed invention as asserted in the disclosure in clear, concise and exact terms, it must be concluded that one would not be enabled to make and use the invention as broadly as claimed.
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.
Claims 1-4, 6-8, 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Kariman (US 2018/0193399) and Changoer et al. (US 2019/0060251) both references are cited on IDS filed 03/06/2023.
Applicant Claims
Claim 1 is directed to a cosmetic and pharmaceutical preparation for topical or inhalatory use containing one or more alkaloids of Mitragyna speciosa and one or more cannabinoids of Cannabis indica or Cannabis sativa, wherein the preparation contains at most 20 wt.-%, of said one or more alkaloids and at most 20 wt.-%, of said one or more cannabinoids.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Kariman teaches pharmaceutical composition and methods for reducing inflammation using the composition. The composition comprises Mitragyna speciose alkaloids and Cannabis sativa based compounds (abstract). Both Cannabis and Mitragyna have anti-inflammatory effect and used to reduce inflammation (¶¶ 0020, 0028, 0045, 0150, 0154; claims 1, 12, 26, 30). The use of the combinations of Cannabis sativa and Mitragyna speciosa extracts is more effective in the treatment of inflammation in subjects in need thereof than each extract alone (¶ 0045). The extracts of Mitragyna speciose alkaloids comprises isopaynantheine, speciociliatine spaciogynine and mitragynine, and Cannabis extract comprises A(9)-tetrahydrocannabinol (THC), cannabidiol (CBD), tetrahydro-cannabinolic acid (THCA) and cannabidiolic acid (CBDA) (¶ 0051). The composition comprises 0.1-70% Cannabis extract; and 0.1-20% Mitragyna speciose extract (¶ 0053). The plants are extracted and purified (¶¶ 0027, 0099, 0100; claims 11, 22). The composition is topical composition, e.g. cream, ointment, etc. (¶¶0104, 0111, 0124). The composition can be administered to a patient in combination with other compounds or drugs having similar or different biological activities, for example, anti-inflammatory agents (¶ 0110).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Karima teaches topical composition comprising combination of Cannabis and Mitragyna speciosa for treating inflammation, and suggests 0.1-20% of Mitragyna speciosa, the reference teaches broad amount of 0.1-70% of Cannabis, that is still embrace the claimed amount, however, for completeness of record, Changoer reference is cited that teaches the claimed amount of cannabis in a topical composition.
Changoer teaches method for treating atopic dermatitis comprising applying topical composition comprising extract of Cannabis in amount of 3-20%. The topical composition can be ointment. Atopic dermatitis is skin inflammation. The topical composition can be administered concomitantly with systemic oral cannabis composition to increase efficacy of the topical application (abstract; ¶¶ 0003, 0010, 0026, 0028, 0040, 0051, 0054, 0062, 0093).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Kariman does not teach a single embodiment with the claimed amounts of the claimed extracts. As such, the reference does not appear to provide sufficient specificity, i.e., involves some much “picking and choosing” to give rise to anticipation. See, Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). That being said, it must be remembered that “[w]hen 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.... the combination is obvious”. KSRv. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). Therefore, Changoer reference is cited
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide a topical composition to treat inflammation comprising 0.1-20% Mitragyna speciosa extract, and 0.1-70% Cannabis extract to treat inflammation as taught by Kariman, and adjust the amount of Cannabis to 3-20% as taught by Changoer. One would have been motivated to do so because Changoer teaches 3-20% in a topical composition treats skin inflammation, e.g. atopic dermatitis. One would reasonably expect formulating topical composition comprising 0.1-20% Mitragyna speciosa extract, and 3-20% Cannabis extract that effectively and successfully treats inflammation of the skin, e.g. atopic dermatitis.
Regarding the claimed amount of as claimed by claims 1, 2, 15-18, the claimed amounts either fall within or overlap with that taught by the cited references. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding claim 3 that purified extracts including alkaloids and cannabinoids isolated from Mitragyna speciosa and Cannabis, respectively, Kariman teaches alkaloids isolated from Mitragyna speciosa and cannabinoids isolated from Cannabis indica and Cannabis sativa.
Regarding alkaloids claimed by claim 4, Kariman teaches isopaynantheine, speciociliatine spaciogynine and mitragynine.
Regarding cannabinoids claimed by claim 4, Kariman teaches CBD, CBDA, THC and THCA.
Regarding topical composition claimed by claims 6, both references teaches topical composition comprising cream, ointment, etc.
Regarding claims 7, 11 and 13 of method of treating skin using topical composition comprising composition of claim 1, combination of the cited references teaches treating skin condition using topical composition of claim 1.
Regarding conditions to be treated as claimed by claim 8, Changoer teaches treating atopic dermatitis which is an inflammatory condition of skin, and Kariman teaches treating inflammation in general.
Regarding claims 12 and 14 that topical administration is used in combination with a dosage form for systemic administration, this is suggested by Changoer to improve efficacy of the treatment.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./