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 .
DETAILED ACTION
This Office Action is in response to Applicant’s Arguments and Amendment filed, 11/24/2025, wherein the Amendment amended claims 1, and 17-18, cancelled claims 8, and added claims 22-24.
Claims 1-7, 9-10, and 17-24 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
Claim Objections
The cancellation of claim 8 is sufficient to overcome this objection.
35 U.S.C. § 112(a)
Applicant’s amendment to claim 1 that deletes “preventing” is sufficient to overcome this rejection.
35 U.S.C. § 102 over Yeshurun
Applicant’s amendment to claim 17 that adds the limitations of previous claim 18, is sufficient to overcome this rejection.
REJECTIONS-Modified & New
Applicant’s amendments to the claims have resulted in the below new and modified rejections. Applicant’s amendments to independent claims 1 and 17 have modified the scope of these claims. As such, the prior art rejections have been modified or are new. CN1253806 and WO 2017/191630 to Yeshurun continue to be relied upon as primary references in the prior art rejections.
Claim Rejections - 35 USC § 112(a)-New Matter
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.
(New) Claims 18-24 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 new matter rejection.
In claim 18, lines 3-4, and claim 23, lines 1-3, the phrases “two cannabinoids in a synergistically effective amount,” and “two cannabinoids. . .in a synergistically effective amount,” respectively, are new matter. The instant specification only provides support for a synergistic effect between CBD and THC in [0266], [0268], and Fig. 10. The instant specification is silent in reference to “a synergistically effective amount” in general, let alone in reference to “two cannabinoids.” Remarks, pg. 6 points to Figs. 10-11 and paragraphs [0269] and [0271] as providing support for this limitation. However, Fig. 10 only shows a synergistic effect between 150uM CBD and 10uM THC, and Fig. 11 only shows additive effects between CBD10 and CBG5; CBD10 and CBG10; CBD5 and CBDV10; CBD5 and CBDV20; and CBD10 and CBDV10. Neither [0269] nor [0271] reference synergism, let alone synergistic effective amounts.
Thus, a careful review of the originally filed specification and claims does not provide support for these limitations.
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
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.
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.
(New) Claims 18-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claims 18, line 4, and 23, lines 2-3, the phrase “synergistically effective amount” renders the claims indefinite. Neither the instant specification nor the prior art provide a limiting definition of a synergistically effective amount in reference two cannabinoids, and it is not clear what baseline measure distinguishes an effective amount of two cannabinoids from a synergistically effective amount of two cannabinoids. This phrase is analogous to a functional limitation as discussed in MPEP 2173.05(g):
When a claim limitation employs functional language, the examiner’s determination of whether the limitation is sufficiently definite will be highly dependent on context (e.g., the disclosure in the specification and the knowledge of a person of ordinary skill in the art). Halliburton Energy Servs., 514 F.3d at 1255, 85 USPQ2d at 1663. For example, a claim that included the term “fragile gel” was found to be indefinite because the definition of the term in the specification was functional, i.e., the fluid is defined by what it does rather than what it is (“ability of the fluid to transition quickly from gel to liquid, and the ability of the fluid to suspend drill cuttings at rest”), and it was ambiguous as to the requisite degree of the fragileness of the gel, the ability of the gel to suspend drill cuttings (i.e., gel strength), and/or some combination of the two. Halliburton Energy Servs., 514 F.3d at 1255-56, 85 USPQ2d at 1663.
…
Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim.
Binding case law from Federal Circuit such as Geneva Pharmaceuticals v. Glaxosmithkline, 349 F.3d 1373, 1384 (Fed. Cir. 2003) has dealt with the same issue regarding “synergistically effective amount” as presented in the instant claims:
A claim is indefinite if its legal scope is not clear enough that a person of ordinary skill in the art could determine whether a particular composition infringes or not. See35 U.S.C. § 112 (2000). Here, "synergy" refers to activity against bacteria that the claims do not identify. By GSK's proposed construction, a formulation (including AUGMENTIN®) might infringe or not depending on its usage in changing circumstances. In other words, a given embodiment would simultaneously infringe and not infringe the claims, depending on the particular bacteria chosen for analysis. Thus, one of skill would not know from one bacterium to the next whether a particular composition standing alone is within the claim scope or not. That is the epitome of indefiniteness.
Geneva Pharmaceuticals v. Glaxosmithkline, 349 F.3d 1373, 1384 (Fed. Cir. 2003). Applied in this case, “synergistic” is unclear as to what effect is being measured. Furthermore, the claim term and the specification do not make clear how the effect is to be evaluated to be within the scope of the claims, whether simply working together in a productive way as defined in legal dictionaries or something else such as greater than individually additive effects.
In the instant case, (1) there is no definition or “clear cut indication” of the scope “synergistically effective amount” provided by the specification or known in the art; (2) the phrase only states a desired result obtained; (3) one of skill in the art would not know how to evaluate whether a given amount is sufficiently synergistic or not based on the claim terms. Thus, the phrase is ambiguous as to the precise scope and is therefore indefinite.
In view of compact prosecution, for the purpose of applying prior art, “a synergistically effective amount” is interpreted as a therapeutically effective amount.
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
(Modified) Claims 1 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 1253806 (published 2000, Translation, PTO-892 of 08/25/2025).
Regarding claim 1, CN ‘806 teaches a topical medicine for treating rhinitis comprising cannabis and vegetable oil or hemp and vegetable oil, wherein vegetable oil is a pharmaceutically acceptable carrier (see [0169] of the instant specification that defines “carrier” and specifies oils as such carriers) (claims 1 and 2; pg. 3, Examples 1, 3).
CN ‘806 teaches rhinitis as including nasal congestion, acute and chronic rhinitis, sinusitis, and multiple nasal polyps (pg. 2). CN ‘806 specifically teaches its medicine as having an over 95% cure rate for nasal polyps (pg. 3) and exemplifies a composition comprising cannabis for the treatment of nasal polyps (pgs. 3-4, Examples 1-6).
Regarding claim 1, the limitation "consisting essentially of" is interpreted no differently than "comprising,” since the instant specification provides no discussion or teaching of what limitations "materially affect the basic and novel characteristic(s)" of the claimed method, see MPEP 2111.03. Thus, the pharmaceutical composition within the method of claim 1 is interpreted as “a pharmaceutical composition comprising an active agent of at least one cannabinoid and a pharmaceutically acceptable carrier.”
Regarding claim 9, CN ‘806 teaches nasal administration (pg. 3).
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 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.
(Modified) Claims 1, 6-7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over CN 1253806 (published 2000, Translation, PTO-892 of 08/25/2025).
CN ‘806 is applied to claims 1 and 9 as discussed above and incorporated herein.
Regarding claims 6 and 7, while CN ‘806 teaches a method of treating nasal polyps and chronic rhinitis by administering cannabis and a pharmaceutically acceptable carrier, it differs from that of instant claims 6 and 7, in that it does not explicitly teach treating a subject with nasal polyps that is afflicted with chronic rhinosinusitis.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select patients with nasal polyps that are afflicted with chronic rhinosinusitis, as the patients in CN ‘806, to arrive at instant claims 6-7. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-CN ‘806 teaches its compositions for the treatment of rhinitis that includes chronic rhinitis, sinusitis, and multiple nasal polyps.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection, to predictably arrive at a method of treating patients with nasal polyps with chronic rhinosinusitis.
Regarding claim 10, while CN ‘806 teaches a method of treating nasal polyps by administering cannabis and a pharmaceutically acceptable carrier, topically to the nasal cavity, it differs from that of instant claim 10 in that it does not explicitly teach contacting the nasal polyp with the composition.
An artisan having ordinary skill in the art would have predictably expected that topically administering the composition to the nasal cavity to patients with nasal polyps would result in contacting the nasal polyps.
(Maintained) Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over CN 1253806 (published 2000, Translation, PTO-892 of 08/25/2025) as applied to claims 1, 6-7 and 9-10 above, and further in view of Burstein (Cannabidiol (CBD) and its analogs: a review of their effects on inflammation, Bioorg Med Chem, published 2015, IDS of 03/05/2025).
CN ‘806 is applied as discussed above and incorporated herein.
While CN ‘806 teaches a method of treating nasal polyps by administering cannabis and a pharmaceutically acceptable carrier, it differs from that of instant claim 2 in that it does not teach the species of cannabinoid in the cannabis.
Burstein teaches CBD and its effects on inflammation (title), and specifically teaches that CBD has anti-inflammatory activity and treats clinical inflammation (paragraph spanning pgs. 11-12).
Burstein teaches the combination of THC and CBD as having a better therapeutic profile in a variety of actions than each cannabinoid component alone (paragraph spanning pgs. 23-24).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select CBD or CBD and THC as in the cannabis of CN ‘806, or modify the cannabis of CN ‘806 to concentrate CBD or CBD and THC, to arrive at instant claim 2. One of ordinary skill in the art would have been motivated to make such a selection or modification, with a reasonable expectation of success, because CN ‘806 teaches its cannabis compositions as having anti-inflammatory effects and Burstein teaches CBD and CBD and THC as having therapeutically effective anti-inflammatory effects.
As such, an artisan having ordinary skill in the art would have been motivated make such a selection or modification to predictably arrive at a composition with potent anti-inflammatory effects to treat nasal polyps.
(Maintained) Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over CN 1253806 (published 2000, Translation, PTO-892 of 08/25/2025) as applied to claims 1, 6-7 and 9-10 above, and further in view of Seiberling (Efficacy of Dexamethasone Versus Fluticasone Nasal Sprays in Postoperative Patients with Chronic Rhinosinusitis with Nasal Polyps, published 201, PTO-892 of 08/25/2025).
CN ‘806 is applied as discussed above and incorporated herein.
While CN ‘806 teaches a method of treating nasal polyps by administering cannabis and a pharmaceutically acceptable carrier, it differs from that of instant claim 3-4 in that it does not teach a glucocorticoid or dexamethasone.
Seiberling teaches that topical nasal steroids are commonly prescribed to patients with chronic rhinosinusitis with nasal polyposis following endoscopic sinus surgery because they improve symptoms and quality of life as well as reduce the incidence of nasal polyp recurrence. Seiberling teaches dexamethasone as such a topical nasal steroid (Abstract).
Seiberling teaches that topical nasal steroid sprays have minimal systemic absorption and can be safely used as a long-term maintenance therapy in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Seiberling teaches that it is well known that topical corticosteroids reduce the rate of polyp recurrence, increase time to polyp recurrence and more (paragraph spanning pgs. 478-479).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to add dexamethasone to CN ‘806’s cannabis composition, to arrive at instant claims 3-5. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-Seiberling teaches that topical nasal steroids, such as dexamethasone, are commonly prescribed to patients with chronic rhinosinusitis with nasal polyposis because they improve symptoms and quality of life as well as reducing the incidence of nasal polyps recurrence, and
-"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
As such, an artisan having ordinary skill in the art would have been motivated to make such an addition to predictably arrive at a more therapeutically effective method of treating nasal polyps that treats nasal polyps and reduces their incidence of reoccurring.
Since the combination of CN ‘806 and Seiberling teach a single composition, the limitation of “concomitantly” in claim 5 is met.
(New) Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over CN 1253806 (published 2000, Translation, PTO-892 of 08/25/2025) in view of Burstein (Cannabidiol (CBD) and its analogs: a review of their effects on inflammation, Bioorg Med Chem, published 2015, IDS of 03/05/2025), as applied to claims 1-2, 6-7 and 9-10 above, and further in view of ElSohly (Constituents of Cannabis Sativa, Chapter 1, published 04/01/2020, PTO-892).
CN ‘806 and Burstein are applied as discussed above and incorporated herein.
While CN ‘806 teaches a method of treating nasal polyps by administering cannabis and a pharmaceutically acceptable carrier, it differs from that of instant claims 23-24 in that it does not specify the cannabinoids in its cannabis or hemp, or specifically teach two cannabinoids present in its composition in a synergistically effective amount.
ElSohly teaches cannabis as a widely distributed plant (pg. 3, “1.1”). ElSohly teaches that many compounds have been identified or isolated from C. sativa, and that the chemical substances isolated from C. sativa include THC, CBG, CBC, CBD, and others (pg. 3, “1.2” and “1.2.1”; pg. 4, Table 1).
An ordinary skilled artisan, in view of the teachings of ElSohly, would reasonably expect the cannabis in the combined method of CN ‘806 and Burstein to comprise both CBD and THC, since ElSohly teaches THC and CBD as major constituents in cannabis (pg. 4, Table 1; pgs. 4-5, “1.2.1.1” and “1.2.1.2; pg. 10, “1.2.1.5.”), and because a) CN ‘806 teaches its cannabis compositions as having anti-inflammatory effect, and b) Burstein teaches CBD and THC as having therapeutically effective anti-inflammatory effects, and further teaches the combination of THC and CBD as having a better therapeutic profile of action than each cannabinoid component alone.
Thus, an artisan having ordinary skill in the art would reasonably expect the cannabis of CN ‘806 to comprise CBD and THC.
And while CN ‘806 does not teach two cannabinoids in a synergistically effective amount, CN ‘806 does teach the cure rate of nasal polyps as over 95%. As such, an ordinary skilled artisan would reasonably expect the cannabinoids in the cannabis of CN ‘806 as in amounts that provide a synergistically effective amount to treat nasal polyps. Moreover, in view of the 112(b) rejection above, a synergistically effective amount is interpreted as a therapeutically effective amount.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
(Modified) Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/191630 to Yeshurun (published 2017, IDS of 03/05/2025).
Yeshurun teaches a method for enhancing the therapeutic effect of a steroid and/or reducing the dose thereof by co-administering CBD with a steroid, and Yeshurun exemplifies administering CBD and dexamethasone (abstract; [052]; [072]; [076]; [0109]; pg. 58, claim 1; pg. 56, Example 5).
Regarding claim 17, while Yeshurun teaches co-administering CBD and dexamethasone, it does not teach mole per mole amounts.
Yeshurun exemplifies administering 150mg oral CBD twice per day and orally administering 3, 2, and 1.5 mg dexamethasone twice a day (pg. 56, Example 5).
Yeshurun teaches the steroid daily dose as a single dose per day or 2-8 doses per day in an amount of 0.2-25 mg/kg, and teaches daily administration of 5-1000mg CBD ([072]). Yeshurun further teaches that the amount of CBD can be modified to produce a therapeutic effect or an amount that elicits the biological or medical response of a tissue or human that is being sought by a researcher, medical doctor, or other clinician, or by the subject himself ([0105]; [0120]).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to modify the m/m ratio of CBD to dexamethasone, to arrive at instant claim 17. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Yeshurun teaches modifying the amounts of CBD and dexamethasone,
-Yeshurun teaches modifying amounts to produce specific therapeutic, biological or medical responses, and
- "[W]here 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." MPEP 2144.05(II)
As such, an artisan having ordinary skill in the art would have been motivated to make a modification to predictably arrive at the most therapeutically effective composition for the patient.
Regarding the “instructions for administering” in claim 17, where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. See MPEP 2112.01.
Yeshurun teaches its compositions in a kit ([076]). Moreover, the teaching of a composition for therapeutic use, implies a kit since compositions for therapeutic administration must be contained.
The phrase “to a subject afflicted with a nasal polyp,” in part (c) of claim 17, is an intended use limitations. Since the prior art composition is capable of performing the intended use, then it meets the limitations of the claim. The intended use of a composition is considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. See MPEP 2112.01 and 2111.02.
(New) Claims 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/191630 to Yeshurun (published 2017, IDS of 03/05/2025) as applied to claim 17 above, and further in view of US 2003/0021752 to Whittle (published 2003, PTO-892).
Yeshurun is applied as discussed above and incorporated herein.
Regarding claim 18, while Yeshurun teaches co-administering CBD and dexamethasone for the treatment of Rheumatoid Arthritis (pg. 56, Example 5), it differs from that of instant claim 18 in that it does not teach two cannabinoids in a synergistically effective amount.
Yeshurun teaches embodiments wherein its compositions comprises THC in amount of less than 20%v/v and/or w/w ([048]).
Whittle teaches a method of treating rheumatoid arthritis by administering a composition comprising CBD and THC (pg. 25-27, claims 49-50, 53 and 100).
Whittle teaches the useful effects of combining THC and CBD ([0105]), and teaches that combinations of THC and CBC in varying proportions are particularly useful in the treatment of certain therapeutic conditions ([0106]-[0107], [0112], [0116]).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add THC to the composition of Example 5 of Yeshurun, to arrive at instant claim 18. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-Yeshurun teaches a method of treating rheumatoid arthritis by administering CBD and dexamethasone,
-Yeshurun teaches that THC can be a component in its compositions,
-Whittle teaches combining CBD with THC for the treatment of rheumatoid arthritis,
-Whittle teaches the combination of CBD and THC as having useful effects in treating diseases, and
- "[W]here 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." MPEP 2144.05(II)
As such, an ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a composition that is effective in treating rheumatoid arthritis and wherein the combination of CBD and THC provides a further beneficial effect in treating the rheumatoid arthritis.
Regarding the synergistically effective amount, the optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Moreover, in view of the 112(b) rejection above, a therapeutically effective amount, i.e., and amount of CBD and THC to treat rheumatoid arthritis, meets the limitation of “two cannabinoids present in. . .a synergistically effective amount.”
As discussed in the above rejection over Yeshurun, alone, “to a subject afflicted with a nasal polyp” is an intended use recitation that is met by the teachings of Yeshurun. Regarding the rejection of Yeshurun in view of Whittle, Applicant is reminded that the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See MPEP 2144 (IV).
Regarding claim 19, Yeshurun teaches dexamethasone.
Regarding claims 20-21, the limitations of these claims are intended use limitations. Since the prior art composition is capable of performing the intended use, then it meets the limitations of the claim. The intended use of a composition is considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. See MPEP 2112.01 and 2111.02.
Moreover, a) Yeshurun teaches oral administration and concomitant administration, and b) the limitations of claims 20-21 are referencing the “instructions.”
(New) Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/191630 to Yeshurun (published 2017, IDS of 03/05/2025) and US 2003/0021752 to Whittle (published 2003, PTO-892), as applied to claims 17-21 above, and further in view of Moia (Lycopene used as Anti-inflammatory Nanodrug for the Treatment of Rheumatoid Arthritis: Animal assay, Pharmacokinetics, ABC Transporter and Tissue Deposition, Colloids and Surfaces B: Biointerfaces, published 01/20/2020, PTO-892).
Yeshurun and Whittle are applied as discussed above and incorporated herein.
While the combination of Yeshurun and Whittle teaches co-administering CBD, THC, and dexamethasone to treatment of Rheumatoid Arthritis (pg. 56, Example 5), it differs from that of instant claim 22 in that it does not teach terpenes.
Moia teaches nanodrug lycopene as useful as an anti-inflammatory for the treatment of rheumatoid arthritis (title, abstract). The anti-inflammatory effects of lycopene are attributed to its ability to modulate pathways responsible for the induction of inflammatory mediators, as well as the signaling pathway of NF-kB (paragraph spanning pgs. 1-2).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add lycopene to the combined co-administration of CBD, THC, and dexamethasone of Yeshurun and Whittle, to arrive at instant claim 22. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-both Moia and the combination of Yeshurun and While, are directed toward the treatment of rheumatoid arthritis, and
-Moia teaches lycopene as an anti-inflammatory for the treatment of rheumatoid arthritis.
As such, and ordinary skilled artisan would have been motivated to make such an addition to predictably arrive at a more potent formulation for the treatment of rheumatoid arthritis.
Response to Arguments
In view of the amendments to the claims, the above rejections have been modified or are new. As such, many of Applicant’s arguments are rendered moot in view of the modified and new rejections. Arguments pertinent to the above rejections are addressed.
On pgs. 8-9, Remarks, Applicant argues that amending claim 1 to recite “consisting essentially of” distinguishes CN ‘806 from instant claim 1.
This argument has been fully considered, but is not found persuasive. As discussed in the above, modified rejection, the limitation "consisting essentially of" is interpreted no differently than "comprising” since the instant specification provides no discussion or teaching of what limitations "materially affect the basic and novel characteristic(s)" of the claimed method, see MPEP 2111.03. Thus, the pharmaceutical composition within the method of claim 1 is interpreted as “a pharmaceutical composition comprising an active agent of at least one cannabinoid and a pharmaceutically acceptable carrier.”
On pgs. 9-10, Remarks, regarding the rejection over CN ‘806 in view of Burstein, Applicant argues that there is no motivation to modify the cannabis of CN ‘806 by selecting or concentrating specific cannabinoids since the cure rate is 95% and that such a modification would significantly reformulate CN ‘806’s composition.
This argument has been fully considered, but is not found persuasive. Burstein teaches CBD as CBD having anti-inflammatory activity that treats clinical inflammation (paragraph spanning pgs. 11-12), and further teaches the combination of THC and CBD as having a better therapeutic profile in a variety of actions than each cannabinoid component alone (paragraph spanning pgs. 23-24).
As such, an artisan having ordinary skill in the art would have been motivated to modify the cannabis of CN ‘806 to concentrate the amount of CBD or CBD and THC, since Burstein teaches these components as having a clinically anti-inflammatory effect, to predictably arrive at a composition with potent anti-inflammatory effects to treat nasal polyps.
On pg. 10, Remarks, Applicant points to claims 1 and 2 of CN ‘806 and further argues that “even in the event that the Hemp/fructus cannabis is formulated at its maximum amount according to either claim 1 or 2, and the other active agents. . .are kept to the minimum. . .the partial amount of Hemp/fructus cannabis within the ‘active agent’ portion would not exceed 40% or 15%,” and “It is clear that a person of skill in the art would not regard Hemp/fructus cannabis as “the active agent” let alone the active agent consists essentially of at least one cannabinoid.”
This argument has been fully considered, but is not found persuasive. As discussed above, “consisting essentially of” is interpreted no differently as “comprising.” And Applicant has provided no evidence that the cannabis of CN ‘806 does not contain CBD or CBD and THC. Since Burstein teaches that CBD, alone, and CBD in combination with THC, as providing clinical anti-inflammatory effects, an artisan having ordinary skill in the art would reasonably expect CBD and THC to be contained within the cannabis, and would be motivated to modify the amounts within the cannabis to arrive at a formulation with the most effective anti-inflammatory effects. And while CN ‘806 teaches a 95% or higher cure rate for nasal polyps, CN ‘806 additionally teaches its compositions as treating acute and chronic rhinitis. As such, an ordinary skilled artisan would still be motivated to modify the amounts/concentration of CBD or CBD and THC to predictably arrive at a composition that is maximally effective to treat both nasal polyps and acute or chronic rhinitis.
On pg. 10, Remarks, Applicant argues that cannabis contains numerous cannabinoids that may work together to achieve an effect, and removing or altering the balance of these components could predictably affect the therapeutic outcome.
This argument has been fully considered, but is not found persuasive. It is first noted that neither the composition nor the active agents of claim 1 exclude additional unrecited elements or components. Second, Applicant has provided no evidence that modifying CBD or CBD and THC amounts in the cannabis recited in CN ‘806 would affect the therapeutic effect of the composition of CN ‘806, especially in view of Burstein which teaches CBD and CBD and THC as having clinical anti-inflammatory effects. Applicant is respectfully reminded that the arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. See MPEP 716.01(c). While Applicant does reference a publication on pg. 10, Remarks, it is noted that this publication has not been provided and there is no further evidence that correlates any teachings of the publication to the formulations of CN ‘806.
On pg. 11, Remarks, regarding Yeshurun, Applicant argues that claim 17 has been amended to recite “to a subject afflicted with a nasal polyp” and that Yeshurun has no implication with respect to this particular subject and/or indication.
This argument has been fully considered, but is not found persuasive. As discussed in the above rejection, the phrase “to a subject afflicted with a nasal polyp,” in part (c) of claim 17, is an intended use recitation. Since the prior art formulation, i.e., Yeshurun, is capable of performing the intended use, then it meets the limitations of the claim. The intended use of a composition is considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. See MPEP 2112.01 and 2111.02.
For these reasons, the instant arguments are not sufficient to overcome the instant rejections.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LAUREN WELLS/Examiner, Art Unit 1622