Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a National Stage entry of PCT/GB2022/051606, filed 06/23/2022, and claims foreign priority to GB2109018.8, filed 6/23/2021.
Information Disclosure Statement
The IDS filed on 12/20/2023 has been considered. See the attached PTO 1449 form.
Claim Status
Claims 1-19 are currently pending and under examination.
Claim Objections
Claims 4, 12-13 are objected to because of the following informalities:
In claim 4, between each alternative agonist of a 5-HT receptor, there is either a comma or a semicolon. For example, the claim recites “psilocybin, psilocin” which are two alternatives separated by a comma and the claim also recites “cis-2a; RR-2b” which are two alternative separated by a semicolon. For grammatical consistency, all the alternative agonist of a 5-HT receptor should be separated by only a comma or only a semicolon.
Similarly, in claim 13, between each alternative disease/disorder listed for treatment, there is either a comma or a semicolon. For example, the claim recites “autoimmune disease, Alzheimer’s disease” which are two alternatives separated by a comma and the claim also recites “dyspepsia; non-cardiac chest pain” which are two alternative separated by a semicolon. For grammatical consistency, all the alternative disease/disorder should be separated by only a comma or only a semicolon.
In claim 12, the recitation “the composition, is for” should delete the comma after “composition” as it is unnecessary.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 5 and 13 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.
Claim 5 in line 4 recites “PSEM 895”. The examiner is unable to find any reference or a commercial source which discloses this particular component. Therefore, it is unclear to the examiner as to what exactly is the component referred to as PSEM 895 in the claim. PSEM89s is a known 5HT3 receptor agonist in the art. The art does not disclose or suggest that PSEM 895 is an alternative name of PSEM89s and thus it is unclear whether PSEM 895 is referring to PSEM89s or not.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 13 recites the broad recitation “pain” in line 4, and the claim also recites “chronic pain” in line 4, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 13 also recites “emesis such as cancer therapy induced vomiting by cytotoxic drugs and radiation”. The phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-15 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Wai et al. (WO2019186207) in view of Dulieu et al. (WO2008127669) and Battaglia (US20140371210).
Wai et al. throughout the reference teaches compositions for treatment of autoimmune disease.
Wai et al. teaches a combined preparation of naltrexone and vitamin D or an active metabolite thereof, in the form of a tablet and oral administration where: “Numerous pharmaceutical forms and formulations for biologically active agents are known in the art, and any and all of these are contemplated by the present invention.” (see e.g. Page 7, 2nd paragraph; Page 9). A tablet is a single unit dosage form. The vitamin D or analogue thereof is administered at a daily dose in the range of about 400 IU to about 10000 IU per dosage form (Page 8, 2nd paragraph), which is about 400/40 = 10 mcg to about 10000/40 = 250 mcg and overlaps the claimed range of 80-200 mcg, or the composition may comprise from 0.01-25% by weight of the vitamin D product (Page 8, last paragraph). The naltrexone is employed in a therapeutically effective amount from about 0.01 to 50 mg (Page 10, 1st paragraph; claims 10-13), which overlaps the claimed range of naltrexone and the claimed weight ratio of calcitriol to naltrexone, with excipients (Page 10, 3rd and 4th paragraphs). See MPEP 2144.05(I): In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Wai et al. teach employing vitamin D or an active metabolite. Wai teaches calcitriol as suitable metabolite of the vitamin D that can be used in the composition. (see e.g. Pages 5-6). The naltrexone and vitamin D products may be provided as a combined preparation, where the vitamin D product may be provided in a crystalline or amorphous form. The combined preparation will be provided in a form that is acceptable, tolerable, and effective for the subject. Numerous pharmaceutical forms and formulations for biologically active agents are known in the art, and any and all of these are contemplated by the present invention. For example, the combined preparation may be formulated in an oral solution, a caplet, a capsule, an injectable, an infusible, a suppository, a lozenge, a tablet, a cream or salve or an alternative topical ointment and the like. (see e.g. Page 7, 2nd paragraph).
The difference between the instant claims and Wai et al. is that Wai et al. do not expressly teach calcitriol formulated for sublingual absorption in an amount of 80-200 micrograms in a ratio to naltrexone of 1:1 to 10:1; wherein the first formulation comprising naltrexone is in the form of a tablet and wherein the second formulation comprising calcitriol is a lyophilized and frozen liquid solution, suspension or emulsion which is attached to the tablet. This deficiency in Wai et al. is cured by the teachings of Dulieu et al. and Battaglia.
Battaglia teaches pharmaceutical compositions for the rapid transbuccal delivery of calcitriol (Claims 19 and 22), thereby bypassing first-pass liver metabolism and gastric/intestinal degradation [0002]. Battaglia also teaches sublingual dosage delivery forms are known to the artisan [0004].
Dulieu et al. teach bilayer dosage forms designed to adhere to the oral mucosa (Abstract; Figure 1; claims 1-39) where the bilayer dosage form allows release of APIs with different rates such as fast and sustained release of the one or more APIs (Page 4, lines 9-12) and contain a mixture of coated and non-coated APIs where the non-coated APIs will be absorbed through the mucous membranes of the mouth, where they enter into the blood stream, and therefore will be fast- acting. On the other hand, the coated APIs will be swallowed and passed through the gastrointestinal system in order to enter the blood stream, and therefore will take much longer to deliver therapeutic effect (Page 4, lines 26-31; page 27, lines 15-24). The API can be in the form of grains, granules, pellets, beads powders, mini-tablets (Page 17, line 32 through page 18, line 2). The APIs are without limitation and include anti-cancers (Page 18, lines 3-7) and vitamin D (page 18, line 32) and 1, 25-dihydroxycholecalciferol (Page 19, lines 4-5), which is calcitriol. Dulieu et al. teach: “Sublingual, gingival and/or buccal medications are administered by placing them in the mouth, either under the tongue (sublingual), on gum tissue (gingival) or between the gum and the cheek (buccal).” (Page 3, lines 1-12), which can help avoid first pass metabolism (Page 13, lines 4-8). Dulieu et al. teach an embodiment where the lyophilized layer (a) is for immediate release while lozenge/tablet (b) is for extended release (Example 9). Dulieu et al. teach that the bilayer dosage form is prepared by providing a suspension suitable for preparing the lyophilized layer (a), providing layer (b) in the form of a tablet or lozenge suitable for preparing the lyophilized mucoadhesive layer (b), adding the suspension layer (a) on said layer (b), freezing the system and lyophilizing (Page 10, lines 4-14; page 32, lines 4-11), which attaches the lyophilized and frozen liquid solution/suspension/emulsion to the tablet/lozenge. Dulieu et al. teach an embodiment where the lyophilized layer (a) is for immediate release while lozenge/tablet (b) is for extended release (Example 9), hence (b) is for release and/or absorption after the other formulation (a) is released and/or absorbed. The tablet/lozenge can be placed in a mould container such as a blister prior to adding the other component (Page 11, lines 25-32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the tablet of Wai et al. with calcitriol formulated for sublingual absorption in an amount of 80-200 micrograms in a ratio to naltrexone of 1:1 to 10:1 wherein the first formulation comprising naltrexone is in the form of a tablet and wherein the second formulation comprising calcitriol is a lyophilized and frozen liquid solution, suspension or emulsion which is attached to the tablet where the naltrexone is formulated for delayed release/absorption after the calcitriol is released/absorbed, as suggested by Dulieu et al. and Battaglia, and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because of the following rationale. Wai et al. suggest an active metabolite of vitamin D, and in this art, the ordinary artisan is aware that calcitriol is the active form of vitamin D and thus obvious over the disclosure of an active metabolite of vitamin D by Wai et al. As discussed supra, Wai also teaches calcitriol as suitable metabolite of the vitamin D that can be used in the composition. It is then merely routine optimization to have a 1:1 to 10:1 ratio of the calcitriol to naltrexone in the single unit dosage form of Wai et al. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Wai et al. suggest employing known pharmaceutical formulations and Dulieu et al. provides a bilayer tablet for sublingual administration that can contain more than 1 API including calcitriol where the bilayer dosage form is prepared by providing a suspension suitable for preparing the lyophilized layer (a), providing layer (b) in the form of a tablet or lozenge suitable for preparing the lyophilized mucoadhesive layer (b), adding the suspension layer (a) on said layer (b), freezing the system and lyophilizing, which attaches the lyophilized and frozen liquid solution/suspension/emulsion to the tablet/lozenge. Wai discloses where the vitamin D product may be provided in a crystalline or amorphous form and Battaglia suggests calcitriol for transmucosal administration as well. Accordingly, it is obvious to formulate a single unit oral dose pharmaceutical tablet composition with calcitriol formulated in a composition for sublingual absorption and naltrexone formulated in a separate delayed release formulation for absorption in the GI tract from the esophagus onwards after the calcitriol is released/absorbed. Sublingual is just the position the bilayer tablet is placed in the oral cavity. In view of the combined references, the ordinary artisan would have a reasonable expectation of success.
Regarding the claimed limitations wherein the single unit oral dose pharmaceutical composition is for use and administered in combination with an agonist of 5-HT receptor for treatment of cognitive/neurological disorders and other diseases recited in the claims, the examiner interprets that these limitations are an intended use of the single unit oral dose pharmaceutical composition and these limitation do not further add to the structure of the claimed single unit oral dose pharmaceutical composition. Thus, the claims reciting these limitations are also included in the rejection.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
Claims 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Wai et al. (WO2019186207) in view of Dulieu et al. (WO2008127669) and Battaglia (US20140371210) as applied to claims 1-15 and 17-18 above and further in view of Maleki et al. (Food Chemistry 2019;299:11 pages), Toledano (US20140275142) and Wendschuh et al. (US20160250270).
The references of Wai et al., Dulieu et al. and Battaglia are discussed in detail above.
The difference between the instant application and Wai et al. as modified by Dulieu et al. and Battaglia, is that Wai et al. as modified by Dulieu et al. and Battaglia, do not expressly teach adding the cannabinoids, flavonoids or terpenes claimed. The deficiency in Wai et al. as modified by Dulieu et al. and Battaglia, is cured by the teachings of Toledano, Maleki et al. and Wendschuh et al.
Maleki et al. teach that flavonoids are anti-inflammatory and include kaempferol, luteolin and catechin (Title; Abstract; Tables 1-2; page 3, 4. Anti-inflammatory effects of flavonoids: Mechanisms of action).
Toledano teaches the compositions for the treatment of pain comprising the combination of naltrexone (Claims 1-2) and calcitriol (Claim 6) for treating migraine (Claim 17) and cancer pain [0021]. Toledano adding one or more pharmacologically active agents such as anti-inflammatory drugs, muscle relaxants and tetrahydrocannabinol derivatives [0049] and NSAIDs [0025-0026].
Wendschuh et al. teach compositions of cannabinoids with flavonoids and terpenes (Abstract; claim 1) where: the cannabinoids include, for example, cannabigerol, cannabidolic acid, cannabidiol, cannabivarin and tetrahydrocannabivarin (Claims 8-10; [0365-0368]) as well as cannabinoids within the context of this disclosure include compounds belonging to any of the following classes of molecules, their derivatives, salts, or analogs: Tetrahydrocannabinol (THC), Tetrahydrocannabivarin (THCV), Cannabichromene (CBC), Cannabichromanon (CBCN), Cannabidiol (CBD), Cannabielsoin (CBE), Cannabidivarin (CBDV), Cannbifuran (CBF), Cannabigerol (CBG), Cannabicyclol (CBL), Cannabinol (CBN), Cannabinodiol (CBND), Cannabitriol (CBT), Cannabivarin (CBV), and Isocanabinoids [0018]; the terpenes include, for example, limonene, myrcene, camphene, bisabolol, humulene and pinene (Claims 6-7, 15-20) as well as terpenoids in their forms ofhemiterpenoids, monoterpenoids, sesquiterpenoids, sesterterpenoid, sesquarterpenoids, tetraterpenoids, Triterpenoids, tetraterpenoids, Polyterpenoids, isoprenoids, and steroids [0022, 0364]; and the flavonoids include, for example, apigenin, catechin and quercetin (Claim 13-14) as well as flavonoids chosen from phenolic acids, stilbenoids, dihydroflavonols, anthocyanins, anthocyanidins, polyphenols, tannins, flavones, flavan-3-ols, Flavan-4-ol, Flavan-3,4-diol flavonols, phytochemicals, antioxidants, homoisoflavonoids, phenylpropanoids, Phloroglucinols coumarins, Naphthodianthrones, Steroid glycosides, bioflavonoids, isoflavonoids, and neoflavonoids [0370].
It would have been obvious to one of ordinary skill in the art before to the effective filing date of the claimed invention to formulate the tablet of Wai et al. as modified by Dulieu et al. and Battaglia with a cannabinoid or flavonoid, as suggested by Dulieu et al., Toldedano, Maleki et al. and Wendschuh et al., and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because of the following rationale. Dulieu et al. teach that APIs include those for treatment of pain and migraine (Page 18, lines 13 and 15) as well as anti-inflammatories (Page 18, line 4). Toledano teach synergistic action from the combination of naltrexone and calcitriol [0027] and to add the cannabinoid tetrahydrocannabinol as well as anti-inflammatory drugs. The artisan in this art is well-aware through the teachings of Maleki et al. that flavonoids are anti-inflammatory compounds. The types of cannabinoid derivatives to employ in combination with flavonoids and terpenes is taught by Wendschuh et al. Consequently, it is obvious to add the cannabinoids, flavonoids and terpenes claimed to the single unit dose pharmaceutical composition of Wai et al. as modified by Dulieu et al. and Battaglia for at least an additive effect of the combined materials with a reasonable expectation of success.
From the combined teaching of the cited reference, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art.
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 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 8, 10, 11, 18 of copending Application No. 18273710 (US20240108583A1). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘710 also claims a single unit oral dose pharmaceutical composition comprising a first active ingredient in a first formulation and a second active ingredient in a second formulation. First active is for absorption in the GI tract and second active is for absorption in the oral cavity. First active is naltrexone in amount of 0.01 to 10 mg and the second active is calcitriol in amount of 80 to 200 mcg. First formulation comprising naltrexone is in form of tablet and second formulation comprising calcitriol is a lyophilized and frozen liquid solution, suspension or emulsion which is attached to the tablet. Second formulation comprising calcitriol is for sublingual absorption. Weight ratio of calcitriol to naltrexone is in range of 1:1 to 10:1. The composition further comprises cannabinoid, flavonoid or terpene including cannabidiol.
Regarding the claimed limitations wherein the single unit oral dose pharmaceutical composition is for use and administered in combination with an agonist of 5-HT receptor for treatment of cognitive/neurological disorders and other diseases recited in the claims, the examiner interprets that these limitations are an intended use of the single unit oral dose pharmaceutical composition and these limitation do not further add to the structure of the claimed single unit oral dose pharmaceutical composition. Thus, the claims reciting these limitations are also included in the rejection.
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to combine the members of the recited categories of components in the
copending claims, because they recite to do SO. Necessary selections of amounts of each component
and routine work by the artisan of ordinary skill in light of the concentration teachings render the
claimed concentrations obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9, 11-20 of copending Application No. 18231114 (US20230381171A1) in view of Wai et al. (WO2019186207), Dulieu et al. (WO2008127669), Battaglia (US20140371210), Maleki et al. (Food Chemistry 2019;299:11 pages), Toledano (US20140275142) and Wendschuh et al. (US20160250270).
‘114 claims a pharmaceutical composition comprising a naltrexone in a combined formulation with a vitamin D product or an active metabolite. Naltrexone is present in amount of from 0.01 top 40 mg per tablet. Vitamin D is administered at a dose of 2,000 IU (50 mcg) to 8,000 IU (200 mcg) per dosage form.
‘114 do not expressly teach calcitriol formulated for sublingual absorption in an amount of 80-200 micrograms in a ratio to naltrexone of 1:1 to 10:1; wherein the first formulation comprising naltrexone is in the form of a tablet and wherein the second formulation comprising calcitriol is a lyophilized and frozen liquid solution, suspension or emulsion which is attached to the tablet. ‘114 also do not expressly teach adding the cannabinoids, flavonoids or terpenes claimed. Wai, Dulieu, Battaglia, Maleki, Toledano and Wendschuh cures these deficiencies.
The teachings of Wai, Dulieu, Battaglia, Maleki, Toledano and Wendschuh discussed supra are incorporated herein.
As discussed supra, Wai, Dulieu, Battaglia render obvious calcitriol formulated for sublingual absorption in an amount of 80-200 micrograms in a ratio to naltrexone of 1:1 to 10:1; wherein the first formulation comprising naltrexone is in the form of a tablet and wherein the second formulation comprising calcitriol is a lyophilized and frozen liquid solution, suspension or emulsion which is attached to the tablet. Maleki, Toledano and Wendschuh render obvious adding the cannabinoids, flavonoids or terpenes claimed.
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to combine the members of the recited categories of components in the
copending claims, because they recite to do SO. Necessary selections of amounts of each component
and routine work by the artisan of ordinary skill in light of the concentration teachings render the
claimed concentrations obvious.
Regarding the claimed limitations wherein the single unit oral dose pharmaceutical composition is for use and administered in combination with an agonist of 5-HT receptor for treatment of cognitive/neurological disorders and other diseases recited in the claims, the examiner interprets that these limitations are an intended use of the single unit oral dose pharmaceutical composition and these limitation do not further add to the structure of the claimed single unit oral dose pharmaceutical composition. Thus, the claims reciting these limitations are also included in the rejection.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/ALI S SAEED/ Examiner, Art Unit 1616
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