DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of cyanidin,
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as the flavylium, and glycerol as the solvent in the reply filed on January 21, 2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Claim 11 is currently under examination as it appears that cyanidin is present in tart cherry powder, although potentially not in the liquid phase, although it is not clear what the metes and bounds of claim 11 are (see below).
Claim Interpretation
Independent claim 1, from which all other claims depend, recites “a liquid phase that consists of chemical species that comprise tetrahydrocannabinol, one or more flavyliums, and solvent” (emphasis added). This phrasing does not limit the liquid phase to tetrahydrocannabinol (THC), one or more flavyliums, and solvent as any chemical species are permitted in the liquid phase. Tetrahydrocannabinol, one or more flavyliums, and solvent are required to be amongst the chemical species present in the liquid phase but any chemical species can be present in the liquid phase.
Claim 1 also recites the phrase “the liquid phase comprises the solvent at a greater concentration by mass than any other chemical species of the liquid phase”. In the response to Restriction Requirement that indicated mixtures of compounds could be elected as the solvent, Applicants indicates that this claim language disallows compositions with more than one solvent. This interpretation is not present in the disclosure as originally filed that could serve to define “solvent” other than the standard definition to one of ordinary skill in the art. Hawley’s Chemical Dictionary defines “solvent” as “a substance capable of dissolving another substance (solute) to form a uniformly dispersed mixture (solution) at the molecular or ionic size level”. Note that in a claim using an open-ended transition term "comprising," the article "a" ordinarily means "one or more." SanDisk Corp. v. Kingston Tech. Co., 695 F.3d 1348, 1360 (Fed. Cir. 2012) ("general rule that the use of the indefinite articles 'a' or 'an' means 'one or more"') and while the liquid phase consists of chemical species, those chemical species comprise a solvent. Therefore the broadest reasonable interpretation of the claims in light of the specification is that “a solvent” can be a combination of materials that alone or in combination are capable of dissolving and the amount by mass of those materials as a whole must be greater than any other chemical species in the liquid phase.
Claim Rejections - 35 USC § 112 – Written Description
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 15 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. This is a written description rejection.
Note for this rejection, the “if” in line 2 of the claim is being interpreted as “is”.
The disclosure as originally filed does not provide sufficient written description of specific formulations and/or general characteristics of such formulations such that “a portion of the tetrahydrocannabinol of the composition is absorbed into the epithelial lining of the gastrointestinal tract of a human following oral administration by the human before the composition enters the stomach of the human”. The residence time in the mouth and esophagus, the only parts of the human gastrointestinal (GI) tract before the stomach, is generally very short, which limits that amount of time and/or amount of contact with the mucosal surfaces of the GI tract that would be expected when a composition is orally administered. While this limitation would be met by any amount of THC absorption, there is no discussion as to a structure-function relationship (e.g., components of the solvent, the viscosity of the composition, manner of administration such as swishing in the mouth prior to swallowing) that can result in such absorption. ¶ [0004] of the PGPub of the instant application discusses that the flavylium component can alter the interaction and behavior of the THC including interactions with other molecules in the GI tract and the epithelial lining, so are certain flavyliums and/or concentrations of the flavylium and/or THC required to bring absorption in this specific region of the GI tract? Must ingredients that limit the availability of THC for possible interaction with the epithelial lining be excluded so such absorption can take place? No example formulations are prepared in the specification and therefore nothing is administered to a subject so no data for any formulation is provided. A description that merely renders a claimed invention obvious may not sufficiently describe the invention for the purposes of the written description requirement of 35 U.S.C. 112 (MPEP 2163 (I)). Here no formulations are prepared, there is no structure function relationship given between the claimed formulations and the claimed parameters to sufficiently demonstrate possession of the full scope of formulations that provide the function of THC absorption in the GI tract of a human before it reaches the stomach after oral administration of the THC and flavylium containing composition.
Claims 16 and 17 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 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. This is a written description rejection.
Each of these claims recites particular pharmaceutical parameters, bioavailability and Tmax of the tetrahydrocannabinol (THC), that are well-known to those of ordinary skill in the art. There is no guidance as to what formulations, e.g., solvents, concentrations, ratio of the ingredient that could affect the absorption of the, etc. result in a formulation that can provide the required THC bioavailability or Tmax upon oral administration. ¶ [0004] of the PGPub of the instant application discusses that the flavylium component can alter the interaction and behavior of the THC including interactions with other molecules in the GI tract and the epithelial lining. This would be reasonably be expected to alter the pharmacokinetics such as the extent and rate of absorption of the THC. No example formulations are prepared in the specification and therefore nothing is administered to a subject so no data for any formulation is provided. A description that merely renders a claimed invention obvious may not sufficiently describe the invention for the purposes of the written description requirement of 35 U.S.C. 112 (MPEP 2163 (I)). Here no formulations are prepared, there is no structure function relationship given between the claimed formulations and the claimed parameters beyond that the flavylium can alter compete with the THC and alter interaction with the epithelial lining, a step required for absorption, to sufficiently demonstrate possession of the full scope of formulations that provide the function required by claims 16 and 17 at the time the application was filed.
Claim Rejections - 35 USC § 112 – Indefiniteness
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 11 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. Claim 11 requires the presence of tart cherry powder, a solid material and therefore is not present in the liquid phase. The liquid phase is required to contain at least one flavylium (claim 1) and claim 11 further requires that that at least one flavylium is “derived from tart cherry powder”, defining at least one of the one or more flavyliums that must be present in the liquid phase of the claimed composition. Based on usage of derived such as at ¶ [0152] of the PGPub of the instant application, derived from is not referring to extraction as such as interpretation does not make sense in view of the phrases such as “wherein at least one flavylium of the one or more flavyliums is derived from the acai berries or the extract thereof” (emphasis added). Does this derived from phrasing mean that at least some of the flavylium must dissolve from the tart cherry powder and/or that some chemical transformation of the compounds present in the tart cherry powder to result in dissolution in the liquid phase is required? Derived implies that some level of structural changes are permitted to the 2-phenylchromenylium flavylium compound but neither the claims nor specification provide any indication of what the scope of at least one flavylium derived from tart cherry powder and its relationship to the powder material that must also be present in the composition so the metes and bounds of claim 11 cannot be determined. Please clarify.
Claim 15 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. Claim 15 recites the word “if” in line 2 but there is no indication what happens “then” and therefore the metes and bounds of the claim cannot be determined as only the first part of the “if then” statement is present as the claim appears to be missing a limitation. Please clarify.
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 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.
Claim(s) 1, 3, 5, 7, 8, 12, 13 and 15 – 20 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2014/154025 (WO’025; all citations from machine translation that accompanies this action) in view of Gaffal et al. (Allergy, 2013) and Rosenkrantz et al. (J Pharm Sci, 1972).
WO’025 discloses flavonoids to inhibit the synthesis and release of leukocyte inflammatory mediators caused by microorganisms or chemical irritants and to promote white blood cell production and release of anti-inflammatory factors to promote the regression of inflammation (p 1, ¶ 1 of spec). Flavonoid compounds are widely distributed in plants and the basic parent nucleus is 2-phenylchromone (formular 1) and such compounds include cyanidin (p 2, ¶ 2 of spec; see also p 5, ¶ top of p 5 of spec). Flavonoids are dissolved such as in water or an organic solvent (p 3, ¶ 1 of spec) and the flavanoid is prepared using a glycerol solvent as a carrier (p 3, ¶ 10 of spec). Disclosed unit dosage forms include sprays and aerosols (p 3, ¶ 1 of spec) and drug administration forms include oral or skin (p 3, ¶ 2 of spec). The dosage and dosage forms are not limited as patients have different conditions so the dosage and administration route will also change and the appropriate dosage and dosage form are selected to be within the ability range of the clinician (bottom of p 4 of the spec).
The presence of THC in the formulation is not disclosed.
Gaffal et al. investigated the anti-inflammatory activity of THC when topically applied to mice (abstract). THC application decreased keratinocyte-derived pro-inflammatory mediators to attenuate contact allergic inflammation (abstract).
Rosenkrantz et al. investigated useful vehicles for the administration of THCs and crude marijuana extracts (whole document, e.g., abstract). THCs are highly viscous oils at room temperature (p 1106, col 2, ¶ 1). As shown in table I, Δ9-THC produced a viscous material with glycerol as the solvent and has a solubility of 0.39 mg/mL.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition comprising cyanidin, THC and a solvent such as glycerol. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because cyanidin and THC are both known in the art to possess anti-inflammatory activity. “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) MPEP 2144.06. Both cyanidin and THC are known in the art as anti-inflammatories so therefore it is prima facie to combine them into a third composition that also would be anti-inflammatory. Glycerol can be used as a solvent for both components as taught by WO’025 and Rosenkrantz et al. WO’025 discussed various dosage forms such as aerosols and sprays and that the form and dosage can be selected by clinicians. The amount of a specific ingredient in a composition 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 reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results depending on factors such as the condition being treated and administration route. There is no evidence of record as to the criticality of the amounts and/or ratio between the flavylium and THC. The amounts of the ingredients will also determine the nutritional energy per gram of the formulation. There is no evidence of record as to the criticality of the nutritional energy per gram or the total volume of the formulation. The total volume of the formulation is also a results effective parameter that can depend on the administration route and the volume and dosage to be administered.
As to the THC absorption upon oral administration prior to reaching the stomach and the pharmacokinetic parameters of the formulation upon administration, it is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 There is no evidence of record that a formulation comprising THC and flavylium in a solvent such as glycerol does not result in the functions required of each of these claims. One of ordinary skill in the art would seek to increase bioavailability so that more of the active agents administered are absorbed by the patient to bring about the desired therapeutic effect while a short Tmax will results in faster absorption and onset of those therapeutic effects after absorption.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over WO’025, Gaffal et al. and Rosenkrantz et al. as applied to claims 1, 3, 5, 7, 8, 12, 13 and 15 – 20 above, and further in view of Shukitt-Hale et al. (Antioxidants, 2016).
WO’025, Gaffal et al. and Rosenkrantz et al. are discussed above.
The presence of tart cherry powder in the claimed composition is not disclosed.
Shukitt-Hale et al. discloses the pretreatment of cell with Montmorency tart cherry powder decreased levels of nitric oxide, tumor necrosis factor-alpha (TNF-α) and cycloxygnease-2 (COX-2) in a dose- and time-dependent manner (whole document, e.g., abstract). Tart cherries like other dark-colored fruits may be effective in reducing inflammation and OS (oxidative stress)-mediated signals (abstract).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate tart cherry powder in the cyanidin, THC and glycerol containing composition of WO’025, Gaffal et al. and Rosenkrantz et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because just as with cyanidin and THC, tart cherry powder is known in the art to possess anti-inflammatory accitivty. “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) MPEP 2144.06. That cyanidin was added to the liquid phase rather than entering the liquid phase from the tart cherry powder when mixed with the liquid phase does not patentably distinguish the instant claims over the prior art which are drawn to a product and not the process of preparing the claimed product.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 5, 7, 8, 11 – 13 and 15 – 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7, 8 12, 14, 15, 17, 33, 40, 61 - 72 of copending Application No. 17/621,879 in view of WO 2014/154025 (WO’025; all citations from machine translation that accompanies this action) in view of Gaffal et al. (Allergy, 2013) and Rosenkrantz et al. optionally further in view of Shukitt-Hale et al. (Antioxidants, 2016). The claims of US’879 recite a composition with a cannabinoid anion, at least present in the solid phase of the composition, and a cannabinoid molecule (claim 7) that can also comprise a solvent (claim 12). The composition is intended for human consumption by drinking and therefore is formulated for oral administration (claim 61).
That the cannabinoid is THC and the presence of flavyliums in the composition is not claimed.
WO’025, Gaffal et al. and Rosenkrantz et al. are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition comprising cyanidin, THC and a solvent such as glycerol. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because cyanidin and THC are both known in the art to possess anti-inflammatory activity. “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) MPEP 2144.06. Both cyanidin and THC are known in the art as anti-inflammatories so therefore it is prima facie to combine them into a third composition that also would be anti-inflammatory. Glycerol can be used as a solvent for both components as taught by WO’025 and Rosenkrantz et al. WO’025 discussed various dosage forms such as aerosols and sprays and that the form and dosage can be selected by clinicians. The amount of a specific ingredient in a composition 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 reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results depending on factors such as the condition being treated and administration route. There is no evidence of record as to the criticality of the amounts and/or ratio between the flavylium and THC. The amounts of the ingredients will also determine the nutritional energy per gram of the formulation. There is no evidence of record as to the criticality of the nutritional energy per gram or the total volume of the formulation. The total volume of the formulation is also a results effective parameter that can depend on the administration route and the volume and dosage to be administered.
As to the THC absorption upon oral administration prior to reaching the stomach and the pharmacokinetic parameters of the formulation upon administration, it is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 There is no evidence of record that a formulation comprising THC and flavylium in a solvent such as glycerol does not result in the functions required of each of these claims. One of ordinary skill in the art would seek to increase bioavailability so that more of the active agents administered are absorbed by the patient to bring about the desired therapeutic effect while a short Tmax will results in faster absorption and onset of those therapeutic effects after absorption.
The presence of tart cherry powder in the claimed composition is not disclosed.
Shukitt-Hale et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate tart cherry powder in the cyanidin, THC and glycerol containing composition of US’879, WO’025, Gaffal et al. and Rosenkrantz et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because just as with cyanidin and THC, tart cherry powder is known in the art to possess anti-inflammatory accitivty. “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) MPEP 2144.06. That cyanidin was added to the liquid phase rather than entering the liquid phase from the tart cherry powder when mixed with the liquid phase does not patentably distinguish the instant claims over the prior art which are drawn to a product and not the process of preparing the claimed product.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618