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 .
Priority
Instant application 18/009,757 filed on 12/12/2022 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
Claims 1-5 ,9, 14, 15, 18, 19, 21, 30, 53-56, 61, 62, 65, 66, 70, 71, 73, 75 and 76 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/23/2022, 07/31/2024, and 10/18/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, directed to a composition comprising a cannabidiol, a naringenin, and a methylsulfonylmethene in the reply filed on 03/26/2026 is acknowledged.
Claims 53-56, 61, 62, 65, 66, 70, 71, 73, 75 and 76 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/26/2026.
Regarding species election, Applicant’s election without traverse of a composition comprising capsule comprising cannabidiol (CBD), naringenin, methylsulfonylmethane (MSM), D-limonene, a plant extract, a sugar, glucosamine, chondroitin sulfate, and vitamin C in the reply filed on 03/26/2026 is acknowledged.
Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
Claim Rejections - 35 USC § 112
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 1 and 3 are 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 claims contain 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.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The courts have stated that, “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 claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully 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.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated that, “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …”) 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 and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed genus is sufficient. See MPEP § 2163.
In the instant case, claims 3 is drawn to “derivative” without limitation. It is not clear what derivatives of a monoterpene are encompassed by the claim.
The genus of “a derivative” is not fully structurally defined. It is unclear what is encompassed by the term “derivative”. The specification provides a definition for a “derivative” only as follows:
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In addition, the instant specification in paragraph [0035] teaches:
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However, the term “structurally related compound” has not been defined.
Methods of synthesizing compounds are, in general, known to the person of ordinary skill.
For example, Zebec (Ziga Zebec, Current Opinion in Chemical Biology 2016, 34:37–43) teaches synthesis of monoterpenes and derivatives using synthetic biology (see title and abstract). Zebec teaches “Traditionally, monoterpenes and their derivatives are extracted from natural sources (generally plants), but this extraction process can be low yielding, costly, and some- times highly dependent on raw material availability [4]; a synthetic biology approach to their synthesis provides a sustainable route to production and opens new possibilities for diversification and discovery”. Further, in the conclusion section, Zebec teaches ”in the near future, we expect to see new computational tools identifying even more genes to add to the monoterpene/ monoterpenoid diversification toolbox; advances in metabolomics and proteomics that will more rapidly identify bottlenecks in engineered biosynthetic pathways; progress in directed protein evolution that will increase product purity and chemical diversity; and ever faster and more robust genome editing techniques that will facilitate the rapid and automated introduction and combinatorial assembly of biosynthetic pathway variants into tailormade high-performance industrial chassis strains. Together, these tools will enable a profound transformation in the bio-industrial production of an increasingly diverse range of monoterpenes and their derivatives.”
Methods of making the myriad of compounds embraced by the instant claims is beyond the skill of the artisan, particularly when certain elements, such as “a derivative” are merely described partially.
As such, the instant specification and instant claims do not provide sufficient description such that one could anticipate what additional elements may be present in the derivatives of monoterpene.
Further, not all possible derivatives of a monoterpene would be useful as pharmaceutical compositions, and the specification does not provide any guidance which derivatives should be synthesized.
"[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated”. See Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004).
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
The rejection would be overcome by amending the claims to remove the term “derivative”.
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, 4, 5, 9, 14, 15, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over GEDO (WO2020021545) in view of LI (Yi-Rong Li, et al., The Journal of Nutritional Biochemistry, Volume 26, Issue 12, 2015, Pages 1467-1478).
GEDO teaches and claims a composition comprising cannabidiol (CBD) and methylsulfonylmethene (MSM) for treating arthritis (see claims 1 and 9):
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Regarding instant claim 2, GEDO teaches oral administration of the composition in “tablets, capsules, lozenges, chewable tablets, suspensions, emulsions and the like” (see paragraph [0075]).
Regarding instant claim 4, GEDO teaches, for example, fatty oils such as sesame oil (see paragraph [0060]).
Regarding instant claim 5, GEDO teaches “Some examples of substances which can serve as pharmaceutically acceptable carriers or components thereof are sugars, such as lactose, glucose and sucrose” (see paragraph [0090]). GEDO also teaches the compositions may further comprise sweeteners (e.g. aspartame, citric acid) (see [0091]).
Regarding instant claim 9, it should be noted that the composition disclosed by GEDO comprises cannabidiol (see claim 1). GEDO also teaches “cannabidiol, or a functional variant thereof” (see paragraph [0042]).
Regarding instant claim 14, the composition disclosed by GEDO comprises glucosamine (see claim 1).
Regarding instant claim 15, the composition disclosed by GEDO comprises chondroitin (see claim 1). GEDO further teaches “In some embodiments, chondroitin is chondroitin sulfate” (see paragraph [0029]).
Regarding instant claim 18, GEDO teaches vitamin E, vitamin D, vitamin K and vitamin A:
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Regarding instant claim 19, GEDO teaches the composition may comprise ascorbic acid (commonly known as Vitamin C) as an antioxidant (see paragraph [0084]).
GEDO does not teach a composition comprising naringenin.
However, LI teaches that naringenin has antiarthritic properties (see page 1477, last paragraph):
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Since GEDO teaches a composition comprising CBD and MSM for treatment of inflammatory joint diseases, including arthritis, and LI teaches naringenin has antiarthritic properties - Applying KSR prong (A) - Combining prior art elements according to known methods to yield predictable results, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine CBD, MSM and naringenin with a reasonable expectation of success. A person of ordinary skill in the art would have been motivated to use the combination for the same purpose - treating inflammations and arthritis.
MPEP 2144.06 states that “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)”.
In the instant case, a person of ordinary skill in the art would be motivated to combine naringenin and the ingredients of the composition disclosed by GEDO to achieve an additive effect in treatments of inflammations and arthritis.
Claims 3 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over GEDO (WO2020021545) in view of LI (Yi-Rong Li, et al., The Journal of Nutritional Biochemistry, Volume 26, Issue 12, 2015, Pages 1467-1478) and further in view of d’Alessio (Patrizia A. d'Alessio et al., Life Sciences92(2013)1151–1156) and in view of NCBI (International Agency for Research on Cancer; 1993. (IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, No. 56.) d-LIMONENE. https://www.ncbi.nlm.nih.gov/books/NBK513608/).
The teachings of GEDO and LI have been discussed above and the teachings are incorporated by reference herein.
Regarding claims 3 and 21, the combination of teachings of GEDO is silent about a composition comprising monoterpene.
d'Alessio teaches d-Limonene (monoterpene) displays anti-inflammatory activities (see title and abstract and conclusion):
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Since GEDO teaches a composition comprising CBS and MSM for treatment of inflammatory joint diseases, including arthritis and LI teaches naringenin has antiarthritic properties, d'Alessio teaches that d-Limonene displays anti-inflammatory properties as diet supplementation - Applying KSR prong (A) - Combining prior art elements according to known methods to yield predictable results, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine CBD, MSM, naringenin and d-Limonene with a reasonable expectation of success. A person of ordinary skill in the art would have been motivated to use it for the same purpose - treating arthritis and inflammations.
In addition, NCBI teaches that d-limonene is a natural liquid extracted from citrus peels with a strong, pleasant lemon-orange aroma, commonly used as a food-grade flavoring additive, fragrance, and natural solvent (see page 3, section 1.2.2). Therefore, one of ordinary skill in the art would have been motivated to prepare compositions comprising d-limonene to achieve a pleasant lemon-orange aroma.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over GEDO (WO2020021545) in view of LI (Yi-Rong Li, et al., The Journal of Nutritional Biochemistry, Volume 26, Issue 12, 2015, Pages 1467-1478) and further in view of Janik (US-2007/0071808-A1) and in view of Al-Tabakha (Al-Tabakha, M. M. (2010). HPMC Capsules: Current Status and Future Prospects. Journal of Pharmacy & Pharmaceutical Sciences, 13(3), 428–442).
The teachings of GEDO and LI have been discussed above and those teachings are incorporated herein by reference.
Regarding the instant claim 30, the combination of teachings of GEDO and LI does not teach the capsule is hydroxymethylcellulose capsule.
Janik teaches and claims hydroxymethyl cellulose capsule:
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Janik teaches that vegetable-based capsules may be preferred by individuals who wish to avoid animal products (see paragraph [0017]):
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Furthermore, Janik teaches the capsules contain honey and may contain additional ingredients such as vitamins and nutritional supplements:
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It should be noted that hydroxymethyl cellulose capsules are also known as hydroxypropyl methylcellulose capsules (HPMC).
Al-Tabakha teaches that Vegicaps Soft are hydroxypropyl methylcellulose (HPMC) (see page 429, last paragraph and Table 1):
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Al-Tabakha teaches that hydroxypropyl methylcellulose (HPMC) is employed for a wide variety of pharmaceutical and food preparation (abstract).
Further, Al-Tabakha teaches hydroxypropyl methylcellulose (HPMC) is used in shell material for capsules (see page 428, second paragraph).
Moreover, Al-Tabakha teaches “The HPMC capsule shells have found popularity for their use with nutraceuticals and over the counter (OTC) formulations (page 430, last paragraph).
Al-Tabakha teaches “the use of HPMC for making capsules without a gelling system may reduce problems associated with dissolution/disintegration” because HPMC capsules are soluble even below 30°C and as low as 10° C and therefore can be taken with cold water” (see page 438, last paragraph and page 439, the first two lines).
In addition, Al-Tabakha teaches “The main area where HPMC capsules can have better prospect compered to gelatin capsules is in wider patients' preferences and the dietary sensitivities in certain markets”.
Since GEDO teaches a composition comprising CBS and MSM for treatments of inflammatory joint diseases, including arthritis and LI teaches naringenin has antiarthritic properties - Applying KSR prong (A) - Combining prior art elements according to known methods to yield predictable results, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine CBD, MSM and naringenin with a reasonable expectation of success. A person of ordinary skill in the art would have been motivated to use the combination for the same purpose - treating arthritis.
Further, regarding claim 30, one of ordinary skill would have been motivated to use hydroxypropyl methylcellulose (HPMC) for making capsules to reduce problems associated with dissolution/disintegration. As taught by Al-Tabakha traditional gelatin capsules should be taken with a worm drink whereas hydroxypropyl methylcellulose capsules can be taken with cold water (see discussion on pages 438/439). In addition, as thought by Janik, hydroxymethyl cellulose capsules are preferred by individuals who wish to avoid animal products (see paragraph [0017]).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
/I.S./Examiner, Art Unit 1621
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