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 .
Status of Claims
No new claim set was filed.
Election/Restrictions
Applicants’ election of Group I (claims 1-15) drawn to a pharmaceutical composition comprising at least 20% punicic acid-self-emulsifying drug delivery system (SEDDS) comprising any one of full spectrum cannabis oil, CBD, THC, Cinnamon oleoresin, or any combination thereof, is acknowledged.
Because Applicants 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 § 818.03 (a)).
As the requirement for restriction is deemed proper, it is maintained and hereby made FINAL.
Claims 16-20 are hereby withdrawn from further consideration by the Examiner, pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. The instant claims have been examined commensurate with the scope of the elected invention. Applicants timely responded to the restriction requirement in the reply filed 1/5/26.
Accordingly, claims 1-15 are under current examination.
Claim Objections
Claims 6, 9-10, 12 and 14 are objected to because of the following informalities:
Claim 6 recites “…wherein the ratio between the CBD, THC and Cinnamon oleoresin to the pomegranate seed oil is between 1:12”. The second “between” is not necessary since there are not two ratios recites.
Claim 9 uses the improper abbreviation for gram. The Examiner suggests amending “gr” to “g” in line 2 in order to obviate this objection.
Claim 10 is not a complete sentence. In order to obviate this objection, the Examiner suggests amending the claim to “The pharmaceutical composition of claim 1, wherein the composition is free of mannitol”.
Claim 12 recites a list of ingredients with their corresponding concentrations. This list is separated by commas. The Examiner suggests adding an “and” or “or” between the last two in the list in order to obviate such objection.
Claim 12 recites “cannabis 0-5% w/w oil”. The Examiner suggests amending to “cannabis oil 0-5% w/w”.
Claim 14 lists multiple steps separated by commas. The Examiner suggests adding an “and” or “or” between the last two steps in the list in order to obviate such objection.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 2, 5-6, 9 and 12-14 rejected under 35 U.S.C. 112(b) 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.
Claims 2 and 5 recites the limitation "pomegranate or snake gourd oil" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claims 2 and 5 depend from claim 1, but claim 1 does not contain a “pomegranate or snake gourd oil” limitation. Therefore, it is unclear what this limitation refers to and how to interpret the claim. The Examiner suggests two options: (1) add pomegranate or snake gourd oil to claim 1 or (2) amend claims 2 and 5 to read “The pharmaceutical composition of claim 1, further comprises pomegranate or snake gourd oil and wherein a ratio between the full spectrum cannabis oil, CBD, THC, and cinnamon oleoresin to the pomegranate or snake gourd oil is between 1:250-1:1” in order to obviate this rejection.
Claims 2 and 5-6 are unclear. Claim 2 recites “wherein a (or the) ratio between the full spectrum cannabis oil, CBD, THC, and cinnamon oleoresin to the pomegranate or snake gourd oil is between 1:250-1:1”. Claim 5 recites “wherein the ratio between the CBD, THC and Cinnamon oleoresin to pomegranate or snake gourd oil is between 1:120-1:1”. The claims do not recite the unit of measurement (e.g., molar, weight, volume). Thus, the metes and bounds of the claims cannot be determined and the claims are indefinite.
Claim 9 recites the limitation "wherein the total amount of mannitol" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 9 depends from claim 1, but claim 1 does not contain a “mannitol” limitation. Therefore, it is unclear what this limitation refers to and how to interpret the claim. The Examiner suggests changing the claim dependency of claim 9 to claim 4 in order to obviate this rejection.
Claim 9 is unclear. Claim 9 recites “…wherein the total amount of mannitol is between 250 mg to 18 gr per day”; however, these claims are directed to a composition not a method of using, for example, administering the composition to a patient, wherein you could measure the amount of an ingredient measured per day. In the instant case, claim 9 is dependent on claim 1 and claim 1 merely recites ingredients in the pharmaceutical composition. That is, the composition has not been administered to anyone. One way to obviate this rejection is to amend claim 9 to recite an amount of mannitol that is in the pharmaceutical composition.
Claim 12 recites “…wherein the concentrations of the ingredients are…cannabis 0-5% w/w oil, CBD 0-5% w/w, THC, Cinnamon oleoresin 0-5% w/w”. Such is unclear because the claim indicates that it is going to list the concentrations of the ingredients; however, THC is listed without a concentration. Therefore, one of ordinary skill in the art would not understand if THC is required to be present in the composition of claim 12 or not. It is noted that all active ingredient species are listed in claim 1 and currently all can be at 0% w/w. In order to be further limiting of claim 1, at least one would need to be present in an amount greater than 0%.
Claims 12 and 14 contain the trademark/trade names: “Tween” and “Span”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a surfactant product and, accordingly, the identification/description is indefinite.
The term "substantially" in claim 13 is a relative term, which renders the claim indefinite. The term "substantially" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 14 is unclear. Claim 14 recites “…wherein the punicic acid-SEDDS is prepared using 250mg of an oil comprising at least 20% punicic acid, 350mg of Tween 80, 155mg of Span 80 and 50 µL of ethanol, mixed by a magnetic stirrer for 20 min, 10 µL of the mixture is then added to 3mL of deionized water, vortexed for 30-60 seconds per emulsion.” It is not clear how 250mg of an oil can comprise multiple ingredients that total more than 250mg. At the very least, the mixture of the Tween 80 and Span 80 is 350 mg + 155 mg = 505 mg plus the mass of 20% punicic acid and ethanol. It is also unclear what 20% punicic acid. Is it an aqueous solution comprising 20% punicic acid? And furthermore, is the 20% based on volume or weight? Thus, the metes and bounds of the claims cannot be determined and the claims are indefinite.
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-8 and 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Gabizon et al. (US 2015/0044314; published: 2/12/15), in view of Bassaganya-Riera et al. (US 2021/0251894; published: 8/19/21; in IDS dated 3/12/24).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Gabizon is directed to pomegranate oil for preventing and treating neurodegenerative diseases [Title].
With regards to instant claims 1, 3-4, 8 and 15, Gabizon teaches formulations for oral administration comprising the therapeutically active pomegranate seed oil, punicic acid fraction thereof into self-emulsifying composition (self-emulsifying drug delivery systems; SEDDS) and wherein said formulation further comprises additives such as mannitol [0088]. Gabizon teaches that the pomegranate seed oil comprises at least 50% punicic acid [claim 2]. Gabizon teaches that the abovementioned formulation is used to treat neurodegenerative diseases [see entire reference; e.g., abstract, claims].
With regards to instant claim 10, the language in [0088] makes it clear that the mannitol is not required to be present in the formulation (”mannitol may also be used”).
With regards to instant claim 11, Gabizon teaches wherein the composition further comprises a therapeutically acceptable diluent or carrier [0032].
With regards to instant claims 12 and 14, Gabizon teaches that the pomegranate oil SEDDS is prepared by: 250 mg of Pomegranate oil, 350 mg of Tween 80, 155 mg of Span 80 and 50 μl of ethanol were mixed by a magnetic stirrer for 20 min, 10 μl of the mixture was then added to 3 ml of deionized water and vortexed for 30-60 seconds an emulsion with nano-sized droplets [0136]. See the above 112b, for the unclear interpretation of the amount of cannabis oil, CBD, THC and/or cinnamon oleoresin. Currently, it is not clear how much CBD is required by instant claim 12 and as recited, the other species can be present at 0%.
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Although Gabizon teaches incorporating therapeutically active agents (see, for e.g., claim 17), Gabizon does not teach incorporating full spectrum cannabis oil, CBD, THC, Cinnamon oleoresin or any combination thereof, as required by instant claim 1. Gabizon does not teach the ratio between the abovementioned active ingredients to the pomegranate or snake gourd oil (e.g., 1:250-1:1, 1:120-1:1, or 1:12), as required by instant claims 2 and 5-6. However, such deficiency is cured by Bassaganya-Riera.
Bassaganya-Riera is directed to beverage compositions comprising water, lecithin, a punicic acid-containing oil, and a cannabinoid-containing oil. Bassaganya-Riera teaches that although CBD is not soluble in water, when vigorously mixed with water and pomegranate seed oil, CBD becomes immiscible [Figs. 3-6]. Bassaganya-Riera teach that punicic acid and cannabinoid synergistically decrease inflammation, can maintain or increase glucose uptake in CD4+ T-cells [claims]. With regards to the claimed ratio of pomegranate oil to full spectrum cannabis oil or CBD, Bassaganya-Riera teaches that the punicic acid-containing oil (e.g., pomegranate seed oil) is present in the composition in an amount ranging from 0.0001-5% w/v and the cannabinoid-containing oil (e.g., full spectrum cannabis oil or CBD) is present in the composition in an amount ranging from 0.001-5% w/v, which reads on, e.g., 1:1 or 1:12.
Gabizon does not teach in a particular embodiment wherein the punicic acid-SEDDS is formulated using snake gourd oil, as required by instant claim 7.
However, Gabizon teaches that punicic acid is also known as trichosanic acid and is found in the seed oil of Punica granatum (Punicaceae, Pomegranate) and Trichosanthes anguina (Cucurbitaceae, snake gourd) [0055].
With regards to instant claim 13, Gabizon teaches that formulating the pomegranate oil or fractions thereof into emulsions significantly enhances the stability [0021] and that the pomegranate oil within the emulsion is highly stable [0143], but does not teach the amount of time that it is stable, such as for 4 weeks, as required by instant claim 13. However, since the prior art comprises the same compounds at the approximately the same concentrations, the composition taught by Gabizon and Bassaganya-Riera must necessarily have the same physical/chemical characteristics as the instant composition; i.e., be capable of remaining substantially stable for 4 weeks. When the structure taught by the reference is identical or substantially identical to that of the claims, the claimed properties or functions are presumed to be inherent. MPEP 2112.01 (I).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Gabizon and Bassaganya-Riera are both directed to punicic acid-containing compositions. Based on these teachings, 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 modify the punicic acid-containing SEDSS of Gabizon by further incorporating a cannabinoid (e.g., CBD) in a 1:1 w/v ratio to pomegranate seed oil to achieve the predictable result of obtaining a composition suitable for providing therapeutic effects. One of ordinary skill in the art would have been motivated to do so because Bassaganya-Riera teaches that the combination of punicic acid and CBD is advantageous for providing a synergistic anti-inflammatory effect and furthermore, punicic acid aids in the miscibility of CBD in an aqueous system.
With regards to instant claims 7, based on these teachings, 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 substitute one punicic acid for another, each of which is taught by the prior art to be useful for the same purpose (punicic acid from Punica granatum (Punicaceae, Pomegranate) and Trichosanthes anguina (Cucurbitaceae, snake gourd) for the purpose of a biological effect in neurodegenerative diseases), in order to form a third composition to be used for the very same purpose (See MPEP 2144.06).
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 would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gabizon et al. (US 2015/0044314; published: 2/12/15) and Bassaganya-Riera et al. (US 2021/0251894; published: 8/19/21; in IDS dated 3/12/24) as applied to claims 1-8 and 10-15 above, and further in view of Hassan (US 2021/0069113; published: 3/11/21).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Gabizon and Bassaganya-Riera teach the limitations of instant claims 1-8 and 10-15 (see rejection above for details).
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Although Gabizon teaches incorporation of mannitol into its SEDDS composition, Gabizon does not teach wherein the total amount of mannitol is between 250 mg to 18 g per day, as required by instant claim 9. However, such deficiency is cured by Hassan.
Hassan is directed to solid unit dosage form for dose individualized drug delivery [Title]. Hassan teaches that such delivery system can be a self-emulsifying drug delivery system (SEDDS), like that of Gabizon. Hassan teaches that mannitol is a filler and is present in an amount ranging from 0.01 to 40% by weight of the solid unit dosage [0023], such as 20 wt% in SEDDS described in Example 25.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The amount of mannitol is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of mannitol in order to best achieve the desired results as such would provide advantageous formulation. 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 engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, one of ordinary skill in the art would have recognized that the amount of mannitol provides the basis (i.e., behaves as a filler) for the formulation and therefore be an optimizable variable.
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 would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Conclusion
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/GENEVIEVE S ALLEY/ Primary Examiner, Art Unit 1617