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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/01/2026 has been entered.
Formal Matters
Claims 1, 6-7, 10, 12-13, 16, 23, 27-32, 34, 39, 44, 58-61, and 64-65 are pending.
Claims 2-5, 8-9, 11, 14-15, 17-22, 24-26, 33, 35-38, 40-43, 45-57, 62-63, and 67 are canceled.
Claims 1, 6, 10, and 44 are amended.
Claims 34, 39, and 65-66 remain withdrawn from consideration as being drawn to a nonelected invention.
Claims 1, 6-7, 10, 12-13, 16, 23, 27-32, 44, 58-61, and 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.
Information Disclosure Statement
The information disclosure statement (IDS) filed 09/01/2026 has been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
REJECTIONS WITHDRAWN
Claim Rejections - 35 USC § 112(b)
The rejection set forth in the Office action dated 07/07/2026 is hereby withdrawn in light of Applicant’s cancelation of claims 5, 11, 45, 62-63, and 67 and Applicant’s amendment to claim 6.
Claim Rejections - 35 USC § 103
The rejections set forth in the Office action dated 07/07/2026 are hereby withdrawn in light of Applicant’s amendments to the claims and in favor of the new grounds of rejection set forth below.
NEW GROUNDS OF OBJECTION/REJECTION
Claim Objections
Claims 6 and 61 objected are to because of the following:
Following Applicant’s cancelation of claim 5, “further” appearing in line 2 of claim 6 should be deleted in order to improve claim readability; and
Because claim 44 already recites “crystalline pitolisant monohydrochloride”, “the pitolisant monohydrochloride is crystalline and has” spanning lines 1-2 of claim 61 should be amended to “the crystalline pitolisant monohydrochloride has” in order to improve claim readability.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 27 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 27 recites “wherein the oral dosage form is a tablet”, however claim 1 already recites that the oral dosage form comprises a tablet, and therefore claim 27 is rejected for failing to further limit the subject matter of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 6-7, 10, 12-13, 16, 23, 27-32, 44, 58-61, and 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 Caron et al (WO 2023/137428 A1, published 07/20/2023, effectively filed 01/13/2022).
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 (i.e., pitolisant 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 pitolisant 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). The composition may be formulated by conventional methods of admixture including blending (e.g., Col. 4 Lines 7-9). Suitable carriers for use in the composition include a binder selected from a group including microcrystalline cellulose (e.g., Col. 4 Lines 10-11 and 23-24). The composition comprises a film coating polymer selected from a group including acrylic acid polymer and polyvinyl alcohol (e.g., Col. 4 Lines 11-12 and 47-53). The film coating polymer may alco include plasticizers, lubricants, and pigments, e.g., polyethylene glycol (e.g., Col. 4 Lines 39-40 and 57-58).
Although Raga et al teach that the composition, preferably in the form of a coated tablet, may comprise a film coating polymer selected from a group including acrylic acid polymer and polyvinyl alcohol as well as plasticizers, lubricants, and pigments, e.g., polyethylene glycol, on the blended active ingredient and carrier, e.g., pitolisant monohydrochloride blended with microcrystalline cellulose, Raga et al do not teach the film coating layer comprising a first layer being a polymeric anti-moisture barrier comprising the polyvinyl alcohol polymer OPADRY® amb II coated onto the blended active ingredient and carrier and a second layer being an enteric coating comprising a copolymer of methacrylic acid and ethyl acrylate and polyethylene glycol surrounding the first layer.
These deficiencies are made up for in the teachings of Caron et al.
Caron et al teach pharmaceutical compositions contained within an oral dosage form, which may be in the form of a tablet, having a coating enabling improved oral delivery (See entire document, e.g., Title, Abstract, [0020]). The composition may comprise a first coating comprising polyvinyl alcohol (partially hydrolysed) further comprising talc, glycerol monocaprylocaprate type 1 and sodium lauryl sulfate, commercially available as OPADRY® amb II, and a second coating comprising methacrylic acid and ethyl acrylate copolymer dispersion also comprising sodium lauryl sulfate and polysorbate 80, commercially available as Eudragit L100, Eudragit L30 D-55, or Kollicoat MAE 30DP (e.g., [0031]-[0032]). Caron et al teach that OPADRY® amb II is a brand name formulation used mainly as a moisture barrier film coating and as a sub-coat to improve the adhesion of functional coatings onto the dosage surface (e.g., [0062]).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, based on the teachings of Raga et al and Caron et al, to provide a unit-dosage form composition in the form of a coated tablet for oral administration to a human patient 1 to 6 times daily comprising crystalline pitolisant monohydrochloride having an X-ray powder diffraction pattern with characteristic peaks (2θ): 11.2°, 19.9°, 20.7°, 34.1° (±0.2°) as an active ingredient from 5 to 100 mg blended with microcrystalline cellulose as carrier and coated with a first coating layer being polyvinyl alcohol (partially hydrolysed) further comprising talc, glycerol monocaprylocaprate type 1 and sodium lauryl sulfate, commercially available as OPADRY® amb II, and a second coating layer being methacrylic acid and ethyl acrylate copolymer dispersion also comprising sodium lauryl sulfate and polysorbate 80, commercially available as Eudragit L100, Eudragit L30 D-55, or Kollicoat MAE 30DP.
One of ordinary skill in the art would have been motivated to add the first and second coating layers taught by Caron et al to the tablet taught by Raga et al because Caron et al teach that the coating improves oral delivery of the pharmaceutical composition. One of ordinary skill in the art would have been motivated to use specifically OPADRY® amb II in the first coating layer because Caron et al teach that OPADRY® amb II is used a moisture barrier film coating and as a sub-coat improving the adhesion of functional coatings onto the dosage surface. There would have been a reasonable expectation of success in adding the first and second coating layers taught by Caron et al to the tablet taught by Raga et al because Raga et al teach the composition as being compatible with a polymer selected from a group including acrylic acid polymer and polyvinyl alcohol and also including plasticizers, lubricants, and pigments, e.g., polyethylene glycol.
The coated tablet of Raga et al in view of Caron et al comprising pitolisant monohydrochloride blended with microcrystalline cellulose meets the limitation of a core tablet of pitolisant monohydrochloride blended with one or more pharmaceutically acceptable excipients of the instant claims. The first coating layer in the coated tablet of Raga et al in view of Caron et al being OPADRY® amb II meets the limitation of the polymeric anti-moisture barrier of the instant claims. The second coating layer in the coated tablet of Raga et al in view of Caron et al being methacrylic acid and ethyl acrylate copolymer dispersion also comprising sodium lauryl sulfate and polysorbate 80 (i.e., polyoxyethylene (20) sorbitan monooleate), commercially available as Eudragit L100, Eudragit L30 D-55, or Kollicoat MAE 30DP, meets the limitation of the enteric coating of the instant claims comprising a copolymer of methacrylic acid and ethyl acrylate of instant claim 44 and meets the limitation of the enteric coating comprising polyethylene glycol of instant claims 7 and 58 as polysorbate 80 (i.e., polyoxyethylene (20) sorbitan monooleate) contains polyethylene glycol chains.
The coated tablet of Raga et al in view of Caron 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 coated tablet of Raga et al in view of Caron et al is identical to the oral dosage form of the instant claims, i.e., a unit-dosage form for oral administration in the form of a tablet comprising crystalline pitolisant monohydrochloride having an X-ray powder diffraction pattern with characteristic peaks (2θ): 11.2°, 19.9°, 20.7°, 34.1° (±0.2°) from 5 to 100 mg blended with microcrystalline cellulose and coated with a first coating layer being OPADRY® amb II, wherein the first coating layer surrounds the pitolisant monohydrochloride and microcrystalline cellulose blended tablet, and a second coating layer being Eudragit L100, Eudragit L30 D-55, or Kollicoat MAE 30DP, wherein the second coating layer surrounds the pitolisant monohydrochloride and microcrystalline cellulose blended tablet and the OPADRY® amb II first coating layer, the coated tablet of Raga et al in view of Caron et al necessarily has each of the pharmacokinetic properties recited in each of instant claims 28-32. 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)). Further, the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicant's pharmacokinetic properties differ, and if so to what extent, from the coated tablet of Raga et al in view of Caron et al, and therefore, the burden of establishing non-obviousness by objective evidence is shifted to Applicant.
Thus, the coated tablet of Raga et al in view of Caron et al renders obvious the oral dosage form of instant claims 1, 6-7, 10, 12-13, 16, 23, 27-32, 44, 58-61, and 64 to the extent of the elected species.
Response to Applicant’s Arguments
Applicant’s arguments filed 09/01/2026 have been fully considered by the Examiner, however the rejections under 35 USC 103 over Raga et al and Stutzman et al set forth in the Office action dated 07/07/2026 have been withdrawn and the combination of Raga et al and Stutzman et al is not being applied in a prior art rejection in the instant Office action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached at (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.E.O./Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
