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 .
Claim Objections
Claim 52 is objected to because of the following informalities:
Claim 52 recites the following minor informality in line two “social anxiety disorder, disorder generalized anxiety disorder”.
Appropriate correction is required.
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.
Claims 61, 62, and 66-70 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.
The term “smaller” in claims 61 and 62 is a relative term which renders the claim indefinite. The term “smaller” 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. It is not clear what is meant by this term such that the artisan would reasonably appreciate the metes and bound of what is encompassed by it. It is not clear how far from the base dose structure one can deviate and still meet the requirement of the claim. For the purposes of examination, smaller will be interpreted to mean that each individual “split doses” deliver less active ingredient than the total daily dose.
The term “substantially equivalent” in claim 66 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. It is not clear what is meant by this term such that the artisan would reasonably appreciate the metes and bound of what is encompassed by it. It is not clear how far from the base dose structure one can deviate and still meet the requirement of the claim. For the purposes of examination, substantially equivalent will be interpreted to mean the split doses comprise the same cannabinoid concentration.
Claims 66-70 recite the limitation "daily dose of CBD". There is insufficient antecedent basis for “CBD” in the claim. For the purposes of examination, CBD will be interpreted to suffice as the “at least one cannabinoid” of instant claim 51.
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 (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 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.
Claims 51 and 63-65 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garti et al. (US 2022/0008381 A1, publication date 01/13/2022).
Garti relates to cannabinoid loaded formulations [abstract] and discloses “[t]o permit another form of oral administration, 5CS formulation was encapsulated in soft gel capsules” [0237]. The 5CS formulations are disclosed at Table 1-1 in paragraph 137 (page 8):
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Use of the formulation includes treating “disorders and conditions associated with anxiety” [0107].
The prior art anticipates instant claims 51 and 63-65 because a skilled artisan would have immediately envisioned oral administration of a composition comprising a cannabinoid, an oil, a hydrophilic surfactant, a co-surfactant and no water (less than 1 wt% water). Wherein the composition is formulated in a soft shell capsule. The prior art is implicitly a method of treating an anxiety disorder in a subject in need thereof because anxiety is a normal human function that everyone is subject to.
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.
1) Claims 51, and 63-65 are rejected under 35 U.S.C. 103 as being unpatentable over Garti et al. (US 2022/0008381 A1, publication date 01/13/2022).
Garti relates to cannabinoid loaded formulations [abstract] to treat disorder and conditions associated with anxiety (i.e., anxiety disorder). In one example, Garti discloses “[t]o permit another form of oral administration, 5CS formulation was encapsulated in soft gel capsules” [0237]. The 5CS formulations are disclosed at Table 1-1 in paragraph 137 (page 8):
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While Garti anticipates instant claim 1 as discussed above, Garti also renders the claims, as discussed presently.
Given the disclosure of each component individually, it would have been prima facie obvious for a person having ordinary skill in the art at, before the effective filling date of the claimed invention, to have selected and combined known components for their established functions with predictable results by following the teachings of Garti. MPEP 2143 and 2144.06(I). Therefore it, would have been obvious for one of ordinary skill in the art, before the effective filling date of the claimed invention, to have treated an anxiety disorder by orally administering a composition comprising a cannabinoid (CBD), an oil, a hydrophilic surfactant, a co-surfactant and less than 1%w/w water to a subject in need thereof. Wherein the composition is formulated as a soft gel capsule.
2) Claims 52-57 are rejected under 35 U.S.C. 103 as being unpatentable over Garti et al. (US 2022/0008381 A1, publication date 01/13/2022) as applied to claims 51 and 63-65 above, and further in view of Blessing et al. (Neurotherapeutics, 2015, v. 12, p. 825-836).
Garti, which is taught above, differs from the instant claims insofar as it does not teach a specific anxiety disorder.
Blessing relates to cannabidiol (CBD) as a potential treatment for anxiety disorders [title]. Blessing “found that existing preclinical evidence strongly supports CBD as a treatment for generalized anxiety disorder” [abstract]. Additionally, Blessing discloses “[e]vidence from human studies strongly supports the potential for CBD as a treatment for anxiety disorders: at oral doses ranging from 300 to 600 mg” [p. 833, col. 1, last paragraph].
The Examiner would like to note that the instant claims do not recite a treatment duration. Therefore the single dose suggested by the prior art reads on the instantly claimed “mg/day” doses because a single dose nevertheless a dose in a day (i.e., mg/day).
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have selected generalized anxiety as the anxiety disorder Garti desires to treat. One would have been motivated to, and had an expectation of success in treating generalized anxiety because Garti desires treating anxiety and Blessing discloses that evidence supports CBD as a treatment for generalized anxiety. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Furthermore, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case, the instantly claimed ranges for doses recited in instant claims 54-57 overlap with the range of the prior art 300-600mg/day, and so a prima facie case of obviousness exists.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have treated generalized anxiety disorder by orally administering the composition disclosed by Garti, and discussed above. Wherein the cannabinoid is administered at a dose within the ranges recited in instant claims 54-57.
Regarding instant claim 53, it is noted that the claim scope is not limited by claim language, i.e. "wherein" or "whereby" clauses, that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure (see MPEP 2111.04). The court in Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005) noted (quoting Minton v. Nat'l Ass'n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a "'whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited'"(see Id.). In the present case, a reduction in the scores recited by instant claim 53 would have been expected because the methods of the prior art describe the same method steps and compositions as instantly claimed.
3) Claims 54-60, and 66-68 are rejected under 35 U.S.C. 103 as being unpatentable over Garti et al. (US 2022/0008381 A1, publication date 01/13/2022) as applied to claims 51 and 63-65 above, and further in view of Friedman (US 10,898,463 B2, date of patent 01/26/2021).
Garti, which is taught above, differs from the instant claims insofar as it does not teach the instantly claimed doses and dosing regimen.
Friedman relates to an oral cannabinoid dosage form [title] and discloses “the pharmaceutical composition is used to treat psychiatric disorders; . . . anxiety” [col. 29, lines 34-35]. “According to some embodiments, the capsules comprises 100, 200, 300, 400, 500 or 600 mg of CBD. According to any one of the above embodiment, the treating comprises administering CBD in the amount of about 100, 200, 300, 400, 500, 600, 800, or 1000 mg/day. The administration comprise administering the pharmaceutical composition in one dose a day or in several doses, e.g. 2, 3, 4, 5, or 6 doses a day” (i.e., instant claims 59, 60 and 66) [col. 28, lines 44-53].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the dosing regimens of Friedman with the method of treating anxiety disorders taught by Garti because, according to Friedman, the dosing regimens disclosed therein are suitable doses for treating disorders such as anxiety. One would have had an expectation of success because Friedman and Garti both teach oral administration of CBD to treat anxiety. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Additionally, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). In the present case, the instantly claimed ranges recited in instant claims 54-58 and 66 overlap with the ranges of the prior art and so a prima facie case of obviousness exists.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have treated an anxiety disorder by orally administering the composition formulated as a soft gel capsule as taught by Garti, and discussed above, at a daily dosage within the ranges recited by instant claims 54-58 and 66. Wherein the daily dose is administered once a day or as a split dose (instant claims 59, 60 and 66).
Regarding instant claims 67-68, Friedman discloses that “the treating comprises improvement in scores of one or more of the rating scales selected from the group consisting of … Hamilton Anxiety (HAM-A)” [sentence spanning col. 25-26]. In a specific study, which included evaluation by HAM-A [ col. 41, line 46], Friedman discloses that “[d]rug capsules are administered orally twice daily, every morning and before bed-time for 6 weeks. There is a fixed dose titration period: subjects begin treatment with 200 mg/day for the first week and the dose is increased by 100 mg each successive week (end of the 2nd week and the 3rd week), to a maximum of 400 mg/day” [col. 44, lines 17-25].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the specific regimen of Friedman with the method of treating anxiety disorders taught by Garti because Friedman discloses that regimen is a suitable dosing regimen for CBD. One would have had an expectation of success because Friedman and Garti both teach oral administration of CBD to treat anxiety. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have treated an anxiety disorder by orally administering the composition taught by Garti, as discussed above, wherein the daily dosage increases from 200g/day to 400mg/day after 1 week of treatment, i.e., daily dose of CBD changes over the course of treatment.
4) Claims 61 and 62 are rejected under 35 U.S.C. 103 as being unpatentable over Garti et al. (US 2022/0008381 A1, publication date 01/13/2022) and Friedman (US 10,898,463 B2, date of patent 01/26/2021) as applied to claims 51, 54-60, and 63-68 above, and further in view of Hartenbach (mdterra, 08/28/2020 [accessed 06/24/2026], https://www.extractlabs.com/cbd-guides/when-is-the-best-time-to-take-cbd/).
Garti and Friedman, which are taught above, differ from the instant claims insofar as they do not teach substantially equivalent and inequivalent split doses.
Garti discloses the composition may be formulated as capsules, chewing gum, a patch, buccal patch, sachets, tablets, lozenge, and a variety of other food products and supplements [0104 & 106].
Friedman does disclose “the capsules comprises 100, 200, 300, 400, 500 or 600 mg of CBD. According to any one of the above embodiment, the treating comprises administering CBD in the amount of about 100, 200, 300, 400, 500, 600, 800, or 1000 mg/day. The administration comprise administering the pharmaceutical composition in one dose a day or in several doses, e.g. 2, 3, 4, 5, or 6 doses a day” [col. 28, lines 44-53].
Hartenbach relates to determining the perfect does of CBD [title & para. 1]. Hartenbach discloses that “people seeking to maximize their benefit from CBD use various products and delivery methods throughout their day to establish as ‘loading dose’ of CBD early on in the day -and then maintain it by grazing with different consumption methods throughout the day” [p. 7, last paragraph].
In an attempt to treat anxiety it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to optimize the dosage regimen such that CBD was administered in equal split doses, or as inequivalent split doses. It has been held that it is not inventive to discover the optimum workable ranges by routine experimentation where, as is here, the general conditions of the claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One of ordinary skill in the art would have been motivated to optimize the dosage regimen because Hartenbach teaches that the dosing schedule, i.e., timing and amount, is important to maximize the benefit of CBD. One would have had an expectation of success because Friedman discloses CBD may be administered several times a day and Garti discloses the composition may be have different formulations.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have treated an anxiety disorder by administering the composition taught by Garti, as discussed above, in a split dose in amounts as described in instant claims 61 and/or 62 (i.e., equal or inequivalent split doses)
5) Claims 69 and 70 are rejected under 35 U.S.C. 103 as being unpatentable over Garti et al. (US 2022/0008381 A1, publication date 01/13/2022) and Friedman (US 10,898,463 B2, date of patent 01/26/2021) as applied to claims 51, 54-60, and 63-68 above, and further in view of Sarris et al. (BMC Psychiatry, 2020, v. 20, issue 24).
Garti and Friedman, which are taught above, differ from the instant claims insofar as they do not teach increasing from 200mg/day to 400mg/day after 2 weeks, and increasing from 400mg/day to 600mg/day after two weeks. However, as discussed above, Friedman teaches administering CBD to treat anxiety wherein the daily dosage increases from 200g/day to 400mg/day at the end of the second week of treatment (see sentence spanning col. 25-26 and col. 44, lines 17-25). Friedman also discloses doses of CBD from 100-1000mg/day [col. 28, lines 49-50].
Sarris relates to cannabis for treating psychiatric disorders and discloses that studies have “revealed tentative support for cannabinoids (namely cannabidiol; CBD) for reducing social anxiety” [title & abstract]. With respect to treating anxiety, Sarris discloses “Another study is assessing the effect of CBD on reducing symptoms of anxiety disorders in a youth cohort (12–25 years old). The Australian-based study is a 12-week open-label pilot, which aims to see if 200 mg–800mg of oral CBD (titrated depending on age, tolerability, and efficacy) is safe and effective for a youth population” [p. 6, col. 1, para. 1].
In attempting to treat an anxiety disorder it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, administered CBD at the dosing amounts and regimens of the instant claims. It has been held that it is not inventive to discover the optimum workable ranges by routine experimentation where, as is here, the general conditions of the claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One of ordinary skill in the art would have been motivated to optimize the method of administering CBD taught by Garti and Friedman to ensure the dosage is suitable with respect to patient for age, tolerability and efficacy of treatment. One would have had an expectation of success because Sarris suggests titrating CBD dosage depending on age, tolerability and efficacy when treating anxiety. Additionally, one would have had an expectation of success because Friedman discloses increase daily CBD dosage at the end of the second week.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have treated anxiety by orally administering the composition taught by Garti, as discussed above, within the instantly claimed amounts and with the instantly claimed dosing regimen (i.e., instant claims 69 and 70).
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.
1) Claims 51-70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2-4, 8-10, 15 19, 21, 22, 26, 33, 37, 38, 43, 48, 50, 52, 70, 71, and 74-76 of copending Application No. US20240252519A1 in view of Friedman (US 10,898,463 B2, date of patent 01/26/2021).
The copending claims disclose a method of treating PTSD comprising orally administering to a subject in need thereof a composition comprising a cannabinoid, an oil, a hydrophilic surfactant, a co-surfactant and 1%wt water [claim 2] wherein the cannabinoid is CBD [claim 26].
The copending claims differ from the instant claims insofar as the copending claims do not disclose treating an anxiety disorder.
Friedman discloses anxiety disorder and PTSD are cannabinoid responsive disorders [col. 29 lines 12 and lines 36].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the teachings of the copending claims and Friedman to treat both anxiety and PTSD because Friedman discloses both disorders are cannabinoid responsive. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
This is a provisional nonstatutory double patenting rejection.
2) Claims 51-70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 3, 11-14, 16-18, 28, 33, 34, 41, 44, 46, 51, 56, 58, 60, 67, 75, 76, 79, and 83-93 of copending Application No. US20240366633A1 in view of Friedman (US 10,898,463 B2, date of patent 01/26/2021).
The copending claims disclose a method of treating opioid use disorder comprising orally administering to a subject in need thereof a composition comprising a cannabinoid, an oil, a hydrophilic surfactant, a co-surfactant and 1%wt water [claim 2] wherein the cannabinoid is CBD [claim 79].
Friedman discloses anxiety disorder and opioid addition withdrawal syndrome are cannabinoid responsive disorders [col. 29, lines 28 and lines 36].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the teachings of the copending claims and Friedman to treat both anxiety and opioid use because Friedman discloses both disorders are cannabinoid responsive. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
This is a provisional nonstatutory double patenting rejection.
3) Claims 51-70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-18, 24, 29, 30, 32, 37, 44, 47, 49, 54, 59, 61, 63, 69, 70, 78-84 of copending Application No. US20240316075A1 in view of Friedman (US 10,898,463 B2, date of patent 01/26/2021).
The copending claims disclose a method of treating opioid use disorder comprising orally administering to a subject in need thereof a composition comprising a cannabinoid, an oil, a hydrophilic surfactant, a co-surfactant and 1%wt water wherein one cannabinoid is CBD [claim 14].
Friedman discloses anxiety disorder and opioid addition withdrawal syndrome are cannabinoid responsive disorders [col. 29, lines 28 and lines 36].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the teachings of the copending claims and Friedman to treat both anxiety and opioid use because Friedman discloses both disorders are cannabinoid responsive. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/C.T.W./ Examiner, Art Unit 1612
/WALTER E WEBB/ Primary Examiner, Art Unit 1612
Prosecution Insights