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 .
Formal Matters
Claims 1, 5-7, 10-13, 16, 23, 27-32, 34, 39, 44-45, and 58-66 are pending.
Claims 2-4, 8-9, 14-15, 17-22, 24-26, 33, 35-38, 40-43, and 46-57 are canceled.
Election/Restriction
Applicant’s election without traverse of Group I, now claims 1, 5-7, 10-13, 16, 23, 27-32, 44-45, and 58-64 in the reply filed on 01/20/2026 is acknowledged.
Applicant has also elected the following in the reply filed on 01/20/2026:
Microcrystalline cellulose as the species of the one or more pharmaceutically acceptable excipients; and
OPADRY® amb II as the species of the polymer(s) comprising the anti-moisture barrier.
Claims 34, 39, and 65-66 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1, 5-7, 10-13, 16, 23, 27-32, 44-45, and 58-64 are under consideration in the instant Office action to the extent of the elected species, i.e., the one or more pharmaceutically acceptable excipients is microcrystalline cellulose and the polymer(s) comprising the anti-moisture barrier is OPADRY® amb II.
Priority
This application is a CON of 19/052,933 filed 02/13/2025 and claims foreign priority to EPO 24306216.3 filed 07/18/2024.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) filed 10/10/2025 and 02/04/2026 have been considered by the Examiner. Regarding the IDS filed 10/10/2025 it is noted that each cited foreign patent document and each cited non-patent literature publication is not present in the instant application file, but is present in the application filed of parent application 19/052,933. A signed copy of each IDS is included with the present Office Action.
Specification
The abstract of the disclosure is objected to because of the typographical error “p” appearing at the end of the last line that should be deleted.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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.
Claims 5-7, 11, 44-45, and 58-64 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.
Claims 5, 11, 44-45, and 62-63 contain the following trademark/trade names: ACRYL-EZE®, OPADRY® amb II, and WAKIX®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade names are used to identify/describe coating products (ACRYL-EZE® and OPADRY® amb II) and a tablet (WAKIX®) and, accordingly, the identification/description is indefinite. Additionally, claims 6-7 are rejected for depending from claim 5 and claims 58-61 and 64 are rejected for depending from claim 44.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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, 5-7, 10-13, 16, 23, 27-32, 44-45, and 58-64 are rejected under 35 U.S.C. 103 as being unpatentable over Raga et al (US 8,207,197 B2, published 06/26/2012, cited in IDS dated 10/10/2025) in view of Stutzman et al (CA 3219239 A1, published 12/15/2022, the corresponding US PGPub, US 2024/0285539 A1, is cited in IDS dated 10/10/2025).
Raga et al teach a unit-dosage form composition preferably in the form of a coated tablet for oral administration to a human patient comprising 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine monohydrochloride as an active ingredient from 1 to 200 mg, more usually from 5 to 100 mg, normally administered from 1 to 6 times daily (See entire document, e.g., Abstract, Col. 3 Lines 34-53). The 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine monohydrochloride is crystalline having an X-ray powder diffraction pattern with characteristic peaks (2θ): 11.2°, 19.9°, 20.7°, 34.1° (±0.2°) (e.g., Col. 1 Lines 53-57). Raga et al found that 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine monohydrochloride is readily soluble in water at room temperature and readily soluble in pH 4.5 simulating gastric media (e.g., Example 4 in Col. 10 Lines 17-45). Raga et al teach administration of the composition comprising 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine monohydrochloride, preferably in the form of a coated tablet, together with pharmaceutically acceptable diluents/excipients or carriers, wherein the pharmaceutically acceptable diluents/excipients or carriers may be selected from lists including microcrystalline cellulose (e.g., Col. 3 Lines 12-17 and 48-50, Col. 4 Lines 10-24, claim 10). Raga et al teach that the composition, preferably in the form of a coated tablet, comprises a film coating polymer such as an acrylic acid polymer or polyvinyl alcohol and may also include plasticizers, lubricants and pigments when necessary, e.g., polyethylene glycol (e.g., Col. 3 Lines 48-50, Col. 4 Lines 10-12, 39-40, 47-53, and 57-58).
Raga et al do not teach the coating of the tablet comprising an anti-moisture barrier comprising OPADRY® amb II surrounding the core of the tablet and an enteric coating comprising ACRYL-EZE® surrounding the core and anti-moisture barrier.
These deficiencies are made up for in the teachings of Stutzman et al.
Stutzman et al teach the application of a protective coating for moisture (i.e., water) sensitive pharmaceutical compositions, for example pharmaceutical tablets (See entire document, e.g., Title, Abstract). The protective coating of Stutzman et al can be applied to a tablet comprising an active pharmaceutical ingredient, wherein the active pharmaceutical ingredient may be any of the many categories of active pharmaceutical ingredients, e.g., histamine receptor antagonists (e.g., [0009], [0021]-[0022]). Stutzman et al teach that the protective coating comprises a wax layer, a film coating layer comprising OPADRY® moisture barrier film coatings such as OPADRY® AMBII, and an enteric coating that is coated onto the film coating layer comprising an ACRYL-EZE® enteric coating (e.g., [0009], [0045], [0047]).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the composition taught by Raga et al with the protective coating taught by Stutzman et al, i.e., provide a composition in the form of a coated tablet comprising 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine monohydrochloride (i.e., pitolisant monohydrochloride) from 5 to 100 mg together with microcrystalline cellulose for oral administration to a human patient from 1 to 6 times daily, wherein 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine monohydrochloride has the properties of being crystalline with an X-ray powder diffraction pattern having characteristic peaks (2θ): 11.2°, 19.9°, 20.7°, 34.1° (±0.2°), wherein the tablet is coated with a wax layer, a film coating layer comprising OPADRY® AMBII moisture barrier film coating, and an enteric coating coated onto the film coating layer comprising ACRYL-EZE®, and wherein the coating further comprises polyethylene glycol.
One of ordinary skill in the art would have been motivated to apply the protective coating taught by Stutzman et al to the tablet taught by Raga et al because Stutzman et al teach this coating as effective for water sensitive pharmaceutical compositions, for which Raga et al teach that 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine monohydrochloride is readily water soluble, which would allow for targeted dissolution of the tablet in the gastrointestinal tract of the human patient. There would have been a reasonable expectation of success in applying the protective coating taught by Stutzman et al to the tablet taught by Raga et al because of the compatibility of the pharmaceutical compositions taught by Raga et al and Stutzman et al, e.g., Raga et al teach compatibility of the film coating layer with polymers based on acrylic acid and polyvinyl alcohol (see above) and Stutzman et al teach compatibility of the protective coating with coated tablets comprising any active pharmaceutical ingredient such as histamine receptor antagonists (see above) as well as binders such as microcrystalline cellulose (see Par. [0029] of Stutzman et al).
The modified coated tablet of Raga et al in view of Stutzman et al render obvious the oral dosage form of instant claims 1, 5-7, 10-13, 16, 23, 27-32, 44-45, and 58-64.
The modified coated tablet of Raga et al in view of Stutzman et al comprising pitolisant monohydrochloride from 5 to 100 mg renders obvious each of the requirements of pitolisant monohydrochloride being present in the oral dosage form in about 20 mg (instant claims 12 and 59) and about 5 mg (instant claims 13 and 60).
Because the modified coated tablet of Raga et al in view of Stutzman et al is the same as the oral dosage form of the instant claims, the modified coated tablet of Raga et al in view of Stutzman et al would necessarily have the properties recited in each of instant claims 28-32 and 62-63. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. "Products of identical chemical composition cannot have mutually exclusive properties" (In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established (In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not" (In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 5-7, 10-13, 16, 23, 27-32, 44-45, and 58-64 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-12, 15-17, 21, and 23-24 of copending Application No. 18/917,144 (hereafter ‘144; reference application) in view of Raga et al (as cited above) and Stutzman et al (as cited above).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
With respect to instant claims 1, 11, and 16, instant claims 1, 11, and 16 recite an oral dosage form comprising a core that comprises pitolisant monohydrochloride and one or more pharmaceutically acceptable excipients; an anti-moisture barrier that surrounds the core; and an enteric coating that surrounds the core and the anti-moisture barrier, wherein the anti-moisture barrier comprises OPADRY® amb II, and wherein the one or more pharmaceutically acceptable excipients are selected from the group consisting of microcrystalline cellulose, crospovidone, talc, magnesium stearate, and colloidal silica.
Claims 1-2, 9-11, and 15-16 of ‘144 recite an oral dosage form comprising a core, and a delayed-release coating that surrounds the core, wherein the core comprises pitolisant or a pharmaceutically acceptable salt, solvate, or hydrate thereof, an alkaline agent, and optionally one or more pharmaceutically acceptable excipients, wherein the core comprises pitolisant monohydrochloride, wherein the dosage form further comprises an anti-moisture barrier, wherein the anti-moisture barrier is positioned between the core and the delayed-release coating, wherein the anti-moisture barrier comprises an OPADRY® polymer, e.g., OPADRY® amb II, wherein the dosage form comprises at least one pharmaceutically acceptable excipient, and wherein the pharmaceutically acceptable excipient is selected from the group consisting of lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and colloidal silica (e.g., anhydrous colloidal silica).
Thus, claim 16 of ‘144 with the dependent limitations of claims 1-2, 9-11, and 15 of ‘144 anticipate instant claims 1, 11, and 16 to the extent of the elected species, i.e., the one or more pharmaceutically acceptable excipients is microcrystalline cellulose and the polymer(s) comprising the anti-moisture barrier is OPADRY® amb II.
With respect to instant claims 44-45 and 64, instant claims 44-45, and 64 recite an oral dosage form comprising a tablet, wherein the tablet comprises a core that comprises crystalline pitolisant monohydrochloride and one or more pharmaceutically acceptable excipients; an anti-moisture barrier that surrounds the core, wherein the anti-moisture barrier comprises an OPADRY® polymer; and an enteric coating that surrounds the core and the anti-moisture barrier, wherein the enteric coating comprises ACRYL-EZE® and a plasticizer, wherein the anti-moisture barrier comprises OPADRY® amb II, and wherein the one or more pharmaceutically acceptable excipients are selected from the group consisting of microcrystalline cellulose, crospovidone, talc, magnesium stearate, and colloidal silica.
Claims 1, 7, 9-11, 15-17, and 23 of ‘144 recite an oral dosage form comprising a core, and a delayed-release coating that surrounds the core, wherein the core comprises pitolisant or a pharmaceutically acceptable salt, solvate, or hydrate thereof, an alkaline agent, and optionally one or more pharmaceutically acceptable excipients, wherein the delayed-release coating comprises a plasticizer, wherein the dosage form further comprises an anti-moisture barrier, wherein the anti-moisture barrier is positioned between the core and the delayed-release coating, wherein the anti-moisture barrier comprises an OPADRY® polymer, e.g., OPADRY® amb II, wherein the dosage form comprises at least one pharmaceutically acceptable excipient, wherein the pharmaceutically acceptable excipient is selected from the group consisting of lactose, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and colloidal silica (e.g., anhydrous colloidal silica), wherein the pitolisant or a pharmaceutically acceptable salt, solvate, or hydrate thereof is crystalline pitolisant monohydrochloride, and wherein the oral dosage form is a tablet.
Thus, claim 23 of ‘144 with the dependent limitations of claims 1, 7, 9-11, and 15-17 of ‘144 anticipate instant claims 44-45 and 64 to the extent of the elected species, i.e., the one or more pharmaceutically acceptable excipients is microcrystalline cellulose and the polymer(s) comprising the anti-moisture barrier is OPADRY® amb II.
With respect to instant claims 5-7, 10, 12-13, 23, 27-32, and 58-63, instant claims 1, 5-7, 10, 12-13, 23, 27-32, and 62 recite an oral dosage form comprising a core that comprises pitolisant monohydrochloride and one or more pharmaceutically acceptable excipients; an anti-moisture barrier that surrounds the core; and an enteric coating that surrounds the core and the anti-moisture barrier, wherein the enteric coating comprises ACRYL-EZE®, wherein the enteric coating further comprises a plasticizer, wherein the plasticizer comprises polyethylene glycol (PEG), wherein the anti-moisture barrier comprises a polyvinyl alcohol (PVA)-based polymer, wherein the oral dosage form comprises about 20 mg of pitolisant monohydrochloride, wherein the oral dosage form comprises about 5 mg of pitolisant monohydrochloride, wherein the pitolisant monohydrochloride is crystalline and has an X-ray diffractogram that comprises characteristic peaks (2θ) at 11.2°, 19.9°, 20.7°, and 34.1° (±0.2°), wherein the oral dosage form is a tablet, wherein the oral dosage form is bioequivalent to another oral dosage form comprising pitolisant monohydrochloride in the same amount, and wherein the another oral dosage form does not comprise an anti-moisture barrier and an enteric coating, wherein orally administering the oral dosage form to a subject provides a Cmax of pitolisant in the subject that is substantially the same as the Cmax of pitolisant provided by orally administering another oral dosage form to a subject comprising pitolisant monohydrochloride in the same amount, wherein the another oral dosage form does not comprise an anti-moisture barrier and an enteric coating, wherein orally administering the oral dosage form once daily to a subject for a period of about 7 days provides a steady state Cmax of pitolisant that is substantially the same as the steady state Cmax of pitolisant following orally administering once daily to a subject for a period of about 7 days another oral dosage form comprising pitolisant monohydrochloride in the same amount, wherein the another oral dosage form does not comprise an anti-moisture barrier and an enteric coating, wherein orally administering the oral dosage form to a subject provides an AUC of pitolisant that is substantially the same as the AUC of pitolisant obtained following orally administering another oral dosage form to a subject comprising pitolisant monohydrochloride in the same amount, wherein the another oral dosage form does not comprise an anti-moisture barrier and an enteric coating, wherein orally administering the oral dosage form once daily to a subject for a period of about 7 days provides a steady state AUC of pitolisant that is substantially the same as the steady state AUC of pitolisant following orally administering once daily to a subject for a period of about 7 days another oral dosage form comprising pitolisant monohydrochloride in the same amount, wherein the another oral dosage form does not comprise an anti-moisture barrier and an enteric coating, and wherein the oral dosage form is bioequivalent to a WAKIX® tablet comprising the same amount of pitolisant monohydrochloride and instant claims 44, 58-61, and 63 recite an oral dosage form comprising a tablet, wherein the tablet comprises a core that comprises crystalline pitolisant monohydrochloride and one or more pharmaceutically acceptable excipients; an anti-moisture barrier that surrounds the core, wherein the anti-moisture barrier comprises an OPADRY® polymer; and an enteric coating that surrounds the core and the anti-moisture barrier, wherein the enteric coating comprises ACRYL-EZE® and a plasticizer, wherein the plasticizer comprises polyethylene glycol (PEG), wherein the oral dosage form comprises about 20 mg of pitolisant monohydrochloride, comprises about 5 mg of pitolisant monohydrochloride, wherein the pitolisant monohydrochloride is crystalline and has an X-ray diffractogram that comprises characteristic peaks (2θ) at 11.2°, 19.9°, 20.7°, and 34.1° (±0.2°), and wherein the oral dosage form is bioequivalent to a WAKIX® tablet comprising the same amount of pitolisant monohydrochloride.
Claims 1-2, 6-12, 15, 17, 21, and 23-24 of ‘144 recite an oral dosage form comprising a core; and a delayed-release coating that surrounds the core, wherein the core comprises pitolisant or a pharmaceutically acceptable salt, solvate, or hydrate thereof; an alkaline agent, and optionally one or more pharmaceutically acceptable excipients, wherein the core comprises pitolisant monohydrochloride, wherein the delayed-release coating comprises ACRYL-EZE®, wherein the delayed-release coating comprises a plasticizer, wherein the plasticizer comprises polyethylene glycol (PEG), e.g., PEG8000, or triethyl citrate, wherein the oral dosage form further comprises an anti-moisture barrier, wherein the anti-moisture barrier is positioned between the core and the delayed-release coating, wherein the anti-moisture barrier comprises an OPADRY® polymer, e.g., OPADRY® amb II, wherein the oral dosage form comprises between about 1 mg and about 100 mg pitolisant or a pharmaceutically acceptable salt, solvate, or hydrate thereof (e.g., between about 1 mg and about 80 mg, between about 1 mg and about 40 mg, between about 1 mg and about 40 mg, between about 20 mg and about 40 mg, between about 40 mg and about 60 mg, or between about 50 mg and about 70 mg), wherein the oral dosage form comprises at least one pharmaceutically acceptable excipient, wherein the pitolisant or a pharmaceutically acceptable salt, solvate, or hydrate thereof is crystalline pitolisant monohydrochloride, wherein the pitolisant or a pharmaceutically acceptable salt, solvate, or hydrate thereof has an X-ray diffractogram that comprises characteristic peaks (2θ) at 11.2°, 19.9°, 20.7°, and 34.1° (±0.2°), wherein the oral dosage form is a tablet, and wherein the dosage form is bioequivalent to a dosage form comprising pitolisant or a pharmaceutically acceptable salt, solvate, or hydrate thereof, in the same amount, that does not comprise a delayed release coating (e.g., WAKIX®), or wherein the dosage form provides a superior bioavailability of pitolisant (e.g., an increase in bioavailability of about 5%, about 10%, about 20%, or greater).
Claims 1-2, 6-12, 15-17, 21, and 23-24 of ‘144 do not recite the oral dosage form comprising an anti-moisture barrier between the core and the delayed-release coating that is OPADRY® amb II, or the oral dosage form comprising at least one pharmaceutically acceptable excipient that is microcrystalline cellulose in a single embodiment.
These deficiencies are made up for in the teachings of Raga et al and Stutzman et al, which have been discussed in detail supra.
It would have been prima facie obvious to one of ordinary skill in the art, based on the teachings of Raga et al and Stutzman et al, to provide a composition in the form of a coated tablet comprising pitolisant monohydrochloride from 5 to 100 mg together with microcrystalline cellulose for oral administration to a human patient from 1 to 6 times daily, wherein 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine monohydrochloride has the properties of being crystalline with an X-ray powder diffraction pattern having characteristic peaks (2θ): 11.2°, 19.9°, 20.7°, 34.1° (±0.2°), wherein the tablet is coated with a wax layer, a film coating layer comprising OPADRY® AMBII moisture barrier film coating, and an enteric coating coated onto the film coating layer comprising ACRYL-EZE®, and wherein the coating further comprises polyethylene glycol. One of ordinary skill in the art would have been motivated to provide pitolisant monohydrochloride together with microcrystalline cellulose because Raga et al teach the administration to a human patient of pitolisant monohydrochloride together with pharmaceutically acceptable diluents/excipients or carriers, wherein the pharmaceutically acceptable diluents/excipients or carriers may be microcrystalline cellulose (see supra) and one of ordinary skill in the art would have been motivated to provide an anti-moisture barrier between the core and the delayed-release coating that is OPADRY® amb II because Stutzman et al teach a protective coating comprising a wax layer, a film coating layer comprising OPADRY® moisture barrier film coatings such as OPADRY® AMBII, and an enteric coating that is coated onto the film coating layer comprising an ACRYL-EZE® enteric coating that is effective for water sensitive pharmaceutical compositions (see supra), for which Raga et al teach that pitolisant monohydrochloride is readily water soluble (see supra), which would allow for targeted dissolution of the dosage form in the gastrointestinal tract of the human patient.
Thus, claims 1-2, 6-12, 15, 17, 21, and 23-24 of ‘144 in view of Raga et al and Stutzman et al render obvious instant claims 5-7, 10, 12-13, 23, 27-32, and 58-63 to the extent of the elected species, i.e., the one or more pharmaceutically acceptable excipients is microcrystalline cellulose and the polymer(s) comprising the anti-moisture barrier is OPADRY® amb II. Specifically regarding instant claims 28-32 and 62-63, because the oral dosage form of claims 1-2, 6-12, 15, 17, 21, and 23-24 of ‘144 in view of Raga et al and Stutzman et al is the same as the oral dosage form of the instant claims, the oral dosage form of claims 1-2, 6-12, 15, 17, 21, and 23-24 of ‘144 in view of Raga et al and Stutzman et al would necessarily have the properties recited in each of instant claims 28-32 and 62-63.
Instant claims 1, 5-7, 10-13, 16, 23, 27-32, 44-45, and 58-64 are directed to an invention not patentably distinct from claims 1-2, 6-12, 15-17, 21, and 23-24 of commonly assigned U.S. Patent No. 18/917,144. Specifically, see above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411 ). Commonly assigned U.S. Patent No. 18/917,144, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAELEIGH ELIZABETH OLSEN whose telephone number is (703)756-1962. The examiner can normally be reached M-F 8-5 PM.
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/K.E.O./Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619