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
Receipt of Applicant’s response dated 06/15/2026 is acknowledged.
Claims 1, 5-7, 10-13, 16, 23, 27-32, 34, 39, 44-45, and 58-67 are pending.
Claims 44 and 58 are amended.
Claim 67 is new.
Claims 2-4, 8-9, 14-15, 17-22, 24-26, 33, 35-38, 40-43, and 46-57 are canceled.
Claims 34, 39, and 65-66 remain withdrawn from consideration as being drawn to a nonelected invention.
Claims 1, 5-7, 10-13, 16, 23, 27-32, 44-45, 58-64, and 67 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 statements (IDS) filed 06/15/2026 and 06/17/2026 have been considered by the Examiner. A signed copy of each IDS is included with the present Office Action.
OBJECTIONS/REJECTIONS WITHDRAWN
Specification
The objection to the abstract set forth in the Office action dated 03/13/2026 is hereby withdrawn in light of Applicant’s amendment to the abstract.
Claim Rejections - 35 USC § 112(b)
The indefiniteness rejection of claims 44, 58-61, and 64 set forth in the Office action dated 03/13/2026 is hereby withdrawn in light of Applicant’s amendment to claim 44.
Double Patenting
The provisional rejection on the ground of nonstatutory double patenting over copending Application No. 18/917,144 set forth in the Office action dated 03/13/2026 is hereby withdrawn in light of Applicant’s filing of the terminal disclaimer dated 06/15/2026 and the approval of said terminal disclaimer.
MAINTAINED/NEW GROUNDS OF REJECTION
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, 45, 62-63, and 67 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.
Note: The instant rejection is a maintained ground of rejection over claims 5-7, 11, 45, and 62-63 and is a new ground of rejection over newly added claim 67.
Claims 5, 11, 45, 62-63, and 67 contain the following trademark/trade names: ACRYL-EZE®, OPADRY® amb II, WAKIX®, and EUDRAGIT® L 100-55. 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®, OPADRY® amb II, and EUDRAGIT® L 100-55) and a tablet (WAKIX®) and, accordingly, the identification/description is indefinite. Additionally, claims 6-7 are rejected for depending from claim 5.
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, cited in Notice of References Cited dated 03/13/2026; the corresponding US PGPub, US 2024/0285539 A1, is cited in IDS dated 10/10/2025).
Note: The instant rejection is a maintained ground of rejection over claims 1, 5-7, 10-13, 16, 23, 27-32, 45, and 59-64 and is a new ground of rejection over claims 44 and 58 as necessitated by Applicant’s amendments to claims 44 and 58.
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.
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over Raga et al (as cited above) in view of Stutzman et al (as cited above) as applied to claims 1, 5-7, 10-13, 16, 23, 27-32, 44-45, and 58-64 above, and further evidenced by Colorcon (“Acryl-EZE®”).
Note: The instant rejection is new ground of rejection over newly added claim 67.
The modified coated tablet of Raga et al in view of Stutzman et al has been discussed in detail supra. The enteric coating comprising ACRYL-EZE® in the modified coated tablet of Raga et al in view of Stutzman et al meets the limitation of “the enteric coating comprises EUDRAGIT® L 100-55” as required by instant claim 67 because, as evidenced by Coloron, ACRYL-EZE® itself comprises EUDRAGIT® L 100-55 (See Product Information Par. on Page 1).
Thus, the modified coated tablet of Raga et al in view of Stutzman et al additionally renders obvious instant claim 67.
Response to Applicant’s Arguments
Applicant’s arguments filed on 06/15/2026 have been considered.
Regarding the rejections under 35 USC 112(b), Applicant argues that the Office has not identified any factual or legal basis demonstrating that the recited trademarks fail to convey a definite meaning to a person of ordinary skill in the art. Applicant argues that the law and the MPEP support the use of a trademark in a claim, pointing to MPEP 608.01(v) alleging that the MPEP expressly permits use of trademarks and trade names and arguing that the USPTO routinely allows claims that recite trademarks including the very types of pharmaceutical excipients at issue here. Applicant argues that Ex parte Simpson reinforces the principle that a claim reciting a trademark is definite where the trademark conveys a well-understood meaning to a person of ordinary skill in the art and argues how each of ACRYL-EZE®, OPADRY® amb II, WAKIX®, and EUDRAGIT® L 100-55 have a well-established meaning to a person of ordinary skill in the art.
The above arguments have been fully considered by the Examiner but are not found persuasive because, firstly, section 608.01(v) of the MPEP applies to the parts of a patent application with the exception of the claims. Further, even if the specification provides a sufficiently descriptive definition of the trademark or the trade name and/or the trademark’s or trade name’s meaning is well-known to the skilled artisan, that trademark or trade name may not appear in the claims. If the 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 the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. In fact, the value of a trademark would be lost to the extent that it became the generic name of a product, rather than used as an identification of a source or origin of a product. Thus, the use of a trademark or trade name in a claim to describe a material or product would not only render a claim indefinite, but would also constitute an improper use of the trademark or trade name. See MPEP 2173.05(u) for more details. Lastly, the argument regarding the USPTO routinely allowing claims that recite trademarks is acknowledged, however, the Examiner is precluded from commenting on the prosecution history of other patent applications.
Regarding the rejection under 35 USC 103, Applicant argues that a person of ordinary skill in the art would have had no reason to apply Stutzman’s protective coating system to a pitolisant dosage form. Applicant argues that Raga teaches a dosage form designed for immediate gastric release whereas the claimed dosage form employs an enteric coating that prevents gastric release, and these approaches reflect fundamentally different and incompatible design objectives. Applicant argues that modifying the immediate-release formulation of Raga to be an enteric-coated formulation would be expected to materially alter pharmacokinetic parameters to delay and reduce drug absorption and, therefore, a person of ordinary skill would neither have been motivated to make the proposed modification nor have reasonably expected it to succeed. Applicant argues unexpected results via submission of a declaration under 37 CFR 1.132, for which Applicant argues that the claimed oral dosage form surprisingly achieves bioequivalence to the immediate release Raga formulation, specifically Cmax and AUC values that are substantially the same as those obtained with an exemplary dosage form of Raga (WAKIX®), which is highly surprising given the structural and functional differences between the formulations. Applicant argues that a person of ordinary skill in the art would not have expected that an enteric-coated formulation designed to avoid gastric release would exhibit bioequivalence to an immediate-release formulation and, to the contrary, such a modification would be expected to alter Cmax and AUC. Applicant argues that the rejection of claims 28-32 and 62-63 improperly invokes inherency because the present claims do not merely recite an unrecognized property of an otherwise obvious composition but rather the claimed formulation is not an obvious variant of the prior art and that by dismissing this property as merely inherent without considering its unexpected nature, the Office has committed legal error.
The above arguments have been fully considered by the Examiner but are not found persuasive because, firstly, the Examiner disagrees that person of ordinary skill in the art would have had no reason to apply Stutzman’s protective coating system to a pitolisant dosage form; as can be seen in the rejection under 35 USC 103 of claims 1, 5-7, 10-13, 16, 23, 27-32, 44-45, and 58-64 above, 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 to allow for targeted dissolution of the tablet in the gastrointestinal tract of the human patient and there would have been a reasonable expectation of success 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 and Stutzman et al teach compatibility of the protective coating with coated tablets comprising any active pharmaceutical ingredient such as histamine receptor antagonists as well as binders such as microcrystalline cellulose (see supra). Further, the Examiner disagrees that modifying the immediate-release formulation of Raga to be an enteric-coated formulation would dissuade a skilled artisan from making the proposed modification because of the expectation of altered pharmacokinetic parameters and, in fact, the data submitted in the declaration shows the bioequivalence of the claimed oral dosage form, which is the same as the modified coated tablet of Raga et al in view of Stutzman et al, to the immediate release Raga formulation. The observation of bioequivalence of the claimed oral dosage form to an immediate-release formulation does not render nonobvious an otherwise known invention. "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious" (Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)). The arguments alleging invoking improper inherency regarding the limitations of claims 28-32 and 62-63 have been fully considered by the Examiner but are not found persuasive because Applicant has not demonstrated that the tablet taught by the prior art applied in the rejection under 35 USC 103 above does not necessarily possess the claimed characteristics of the presently claimed oral dosage form. "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)). Regarding the argument of differing design objectives in the teaching of Raga versus the instant application, the art needs to provide “a motivation” and not the same motivation as Applicant or necessarily recognize the same problem/solution as Applicant. "In determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls." KSR Int'l Co. v. Teleflex lnc., 550 U.S. 398,419 (2007). Instead, "any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed." Id. at 420.
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
Prosecution Insights