DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-18 were previously pending.
By virtue of a Preliminary Amendment, filed by Applicant on 24 January 2025, claims 2-18 were amended and claims 19-20 were added. No claims were cancelled.
Therefore, claims 1-20 are now pending and currently under examination.
Priority
Acknowledgement is made of Applicant’s claim to the following priority:
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Information Disclosure Statement (IDS)
The IDSs (5) filed on 24 January 2025, 31 March 2025, 16 May 2025, 30 July 2025, and 18 March 2026 have been considered by the examiner. Signed copies are enclosed.
Applicant is reminded of their duty to disclose to the Office all information known to the person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section.”
Claim Warning
Applicant is advised that should claim 1 be found allowable, claim 8 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 8 recites “[a] pharmaceutical composition comprising a combination of claim 1, and optionally one or more pharmaceutically acceptable excipients.” The characterization of claim 8 as a ‘pharmaceutical composition’ does not, without additional structural or compositional requirements, distinguish the claimed subject matter from the combination recited in claim 1. Further, the recitation of ‘optionally one or more pharmaceutically acceptable excipients’ does not require the presence of an excipient and therefore, does not further limit the combination of claim 1. Consequently, claims 1 and 8 encompass the same subject matter.
Claim Rejections
Claim Rejections - 35 USC § 112(a):
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 6 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the administration of specific pitolisant formulations for treating certain diseases or disorders, does not reasonably provide enablement for the full scope of the claimed method of prevention. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01(A)).
These include:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based
on the content of the disclosure
All of the Wands factors have been considered with regard to the instant claims as discussed below. The Wands factors support a finding of nonenablement.
(A)/(B) The breadth of the claims/The nature of the invention and (F)/(G) The amount of direction provided by the inventor/The existence of working examples:
Claim 6 is directed to a method of treating or preventing a disease or disorder chosen from the group consisting of excessive daytime sleepiness (EDS), cataplexy, narcolepsy, sleep apnea, sleep induced apnea, diurnal somnolence, severe fatigue, and idiopathic hypersomnia by administering a combination of a salt of pitolisant with an alkalinizing agent. Through its dependency from claim 1, the method encompasses administering any salt of a pitolisant in combination with any alkalinizing agent in any amount, ratio, dosage form, dosage regimen, or route of administration. Further, the claim encompasses preventing any one of eight separately identified diseases or disorders. The conditions of the claimed diseases are not manifestations of a single, uniform pathology.
For purposes of this rejection, ‘preventing’ is given its broadest reasonable interpretation as prophylactically administering the claimed combination to prevent or reduce the likelihood of the initial occurrence or recurrence of at least one of the listed diseases or disorders. Although the specification may state generally that ‘treatment’ includes preventing occurrence or reoccurrence (see [0115]), such as statement does not, by itself, teach how to prevent the full range of broadly recited diseases and disorders using the claimed combinations.
Prevention is materially different from treatment of an existing condition. Treatment may be evaluated by observing improvement of symptoms in a patient already exhibiting these symptoms. Prevention generally requires identifying an at-risk, but unaffected or presently asymptomatic population, administering the composition before onset or recurrence, and determining whether the incidence of the condition is reduced relative to an appropriate control population.
Moreover, the claimed diseases or disorders are not manifestations of a single, uniform pathological mechanism. Narcolepsy and idiopathic hypersomnia are central disorders of hypersomnolence, whereas sleep apnea is generally associated with repeated interruption of breathing during sleep and may have obstructive causes. EDS, diurnal somnolence, severe fatigue, and cataplexy are symptoms or manifestations that can arise from different underlying conditions.
Accordingly, evidence that a pitolisant salt treats EDS or cataplexy in a patient with narcolepsy does not reasonably establish that pitolisant prevents narcolepsy from developing or prevents etiologically distinct disorders such as sleep apnea.
Claim 6 is therefore exceptionally broad.
The specification provides insufficient direction concerning prophylactic use of the claimed combination. Although the disclosure describes pitolisant formulations containing alkalinizing agents and provides alleged improvements in absorption, permeability, or pharmacokinetic properties, it does not provide meaningful guidance identifying: 1) patients who should receive the composition before onset of the claimed disease or disorder; 2) risk factors indicating susceptibility to the initial development of the disease or disorder; 3) prophylactic doses or schedules; 4) duration of administration; 5) prevention endpoints; 6) magnitude of risk reduction which would constitute ‘prevention’; and 7) the specific combination of ptiolisant salt and alkalinizing agent. Guidance concerning preparation of a formulation or modification of pitolisant absorption does not reach whether or how the formulation prevents the initial occurrent or recurrence of each claimed disease or disorder. Therefore, the disclosure provides little more than an invitation to investigate whether particular formulations might possess prophylactic efficacy.
In addition, the specification does not provide representative working examples demonstrating prevention of the claimed diseases or disorders. The disclosed studies primarily concern formulation properties, stability, permeability, pharmacokinetics, bioavailability, or treatment-related use (Examples 1 through 5). The specification further does not provide a prophetic example containing sufficient procedural detail to instruct a skilled artisan how to conduct prophylactic treatment and determine prevention has occurred.
The absence of working examples relating to prevention is not, by itself, dispositive. However, in this instance it is significant considering the breadth of the claim, the limited prophylactic guidance, and the unpredictability of whether a pharmacokinetic modification will produce the claimed preventive clinical effect.
(C)/(E) The state of the prior art/The level of predictability in the art:
As of the effective filing date of the claimed invention, pitolisant was known in the art for treating EDS and cataplexy in patients with narcolepsy.1 The existence of an established therapeutic use may assist a skilled artisan in treating those existing symptoms. It does not, however, establish that pitolisant prevents the initial development of narcolepsy, sleep apnea, idiopathic hypersomnia, or any of the bother broadly recited conditions. Thus, the prior art does not supply the missing prophylactic guidance or provide a generally accepted correlation from which preventive efficacy across the claimed conditions could reasonably be predicted. Thus, the prior art does not supply the missing prophylactic guidance or provide a generally accepted correlation from which preventive efficacy across the claimed conditions could reasonably be predicted.
The art is unpredictable with respect to the claimed preventive result. The effect of alkalinizing agent on pitolisant depends on variables including the identity and quantity of the alkalinizing agent, the pitolisant salt, gastrointestinal pH, dissolution, ionization, precipitation, formulation stability, release location, intestinal permeability, and patient physiology.
Even if a particular alkalinizing agent increasing pitolisant permeability or systemic exposure, it cannot be predicted from that result alone that the formulation will prevent the initial occurrent or recurrence of the broadly claimed diseases or disorders. The clinical response is also unpredictable among the different claimed diseases or disorders. Prevention of a cataplexy episode in a patient already diagnosed with narcolepsy does not establish prevention of narcolepsy itself. The specification does not overcome the lack of prior art disclosure as the specification fails to provide a common mechanism by which the claimed formulations would predictably prevent all listed alternatives of diseases or disorders.
D) The level of one of ordinary skill:
The skilled artisan would possess knowledge of pharmaceutical formulation, pharmacokinetics, and treatment of sleep-related disorders. This level of skill would permit preparation of conventional pitolisant dosage forms and performance of routine formulation or pharmacokinetic testing.
Nevertheless, a high level of skill does not substitute for the absence of disclosed prophylactic regimens or evidence of preventive efficacy. The skilled artisan would still be required to design and conduct substantial research to determine whether any particular combination prevents a particular claimed disease or disorder. Such research would involve making significant clinical and pharmacological discoveries rather than merely applying routine techniques to a sufficiently described invention.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
A substantial quantity of experimentation would be required to practice the claimed method throughout its scope. For each claimed disease or disorder, a skilled artisan would need to determine, at a minimum: 1) which patient population is sufficiently at risk to warrant prophylactic treatment; 2) which pitolisant salt should be administered; 3) which alkalinizing agent is compatible with that salt and pharmaceutically acceptable at the required dose; 4) the relative quantities of pitolisant salt and alkalinizing agent; 5) the appropriate dosage form and route of administration; 6) the timing and duration of prophylactic administration; 7) the dose necessary to obtain a preventive, rather than merely symptomatic or therapeutic effect; 8) the objective clinical endpoint by which prevention is determined; and 9) whether the formulation actually prevents the initial occurrence or recurrence of the selected condition.
The aforementioned determinations could not be made merely by preparing the claimed combination. They would require separate formulation, pharmacokinetic, dose ranging, and controlled prophylactic efficacy studies for materially different patient populations and diseases/disorders. The required experimentation is therefore extensive in both quantity and scope.
Accordingly, while the specification may provide information relevant to the treatment of the claimed diseases/disorders, the specification does not enable
the full scope of claim 6 insofar as the prevention of the claimed diseases/disorders. Therefore, claim 6 is not enabled commensurate with its scope and is rejected under 35 USC 112(a) for lack of enablement.
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 3, 5-8, 10, and 18 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 3 and 18 are rejected under 35 USC 112(b) because both claims recite a list of alkalinizing agents that are grammatically and chemically ambiguous. It is unclear whether ‘salts’ modifies: 1) only potassium, magnesium, calcium, or sodium (see specification, [0045]); 2) all preceding compounds; 3) only sodium; or 4) combinations of the recited anions and cations. A clearer claim would separately identify complete species or genera.
Claim 5 is rejected under 35 USC 112(b) because the claim recites the limitation ‘alkalinizing agent/alkalinizing agent+pitolisant salt’ in parenthesis. The limitation is written in mathematical formula format, instead of using ordinary language associated with ratios such as alkalinizing agent to alkalinizing agent and pitolisant salt. The parenthetical limitation does not clearly define the claimed weight ratio because it is unclear which terms are included in the denominator. Specifically, the expression may be interpreted as either:
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In addition, claim 5 further recites “…wherein the weight ratio…is between 5 and 99%.” Because of the claim construction, it is unclear whether the endpoints 5% and 99% are included in the recited ratio.
Accordingly, one of ordinary skill in the art could not determine, with reasonable certainty, how the claimed ratio is to be calculated and interpreted, rendering the scope of claim 5 indefinite.
Claims 6-8 are rejected under 35 USC 112(b) because each claim recites “…a combination of claim 1” (primary antecedent basis) when claim 1 already recites ‘a combination.’ It is unclear what combination claims 6-8 are referring to as reference to any previously recited limitation from which the claims depend should establish secondary antecedent basis by use of either ‘said’ or ‘the.’
Claim 10 is rejected under 35 USC 112(b) because the claim recites the limitation ‘the tablet’ in claim 8. Claim 8 does not recite a tablet and therefore, there is insufficient antecedent basis for this limitation in claim 10.
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, 8-11, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Wakix (FDA Label, revised 10/2020) in view of Raga (US Pat. No. 8,207,197 B2; date of patent: 26 June 2012) and further in view of Bertelsen (US Pat. No. 8,231,899 B2; date of patent: 31 July 2012).
Wakix teaches pitolisant tablets for oral use (p. 1). Wakix teaches the tablets contain pitolisant hydrochloride and other pharmaceutically acceptable excipients (p. 10). Wakix therefore teaches a salt of pitolisant, particularly pitolisant hydrochloride. Wakix further teaches the tablet is used to treat excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy (p. 1). Finally, Wakix teaches the tablets are film-coated wherein the core contains pitolisant hydrochloride (p. 10).
Wakix teaches an orally administered, film-coated tablet comprising a pitolisant hydrochloride core to treat EDS and cataplexy in adults with narcolepsy. While Wakix does not expressly teach an alkalinizing agent, this limitation is made obvious by Raga and Bertelsen.
Raga is directed to the same active pharmaceutical ingredient used in Wakix, 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine monohydrochloride (i.e., pitolisant hydrochloride), and the respective manufacture, methods of use, and compositions containing such a compound (abstract). Raga further identifies preferred dosage forms as tablets and coated tablets (col. 3, lines 48-50).
Raga further identifies suitable carriers comprising: a diluent; binder; disintegrant; lubricant; glidant; and film-coating polymer. Most importantly, Raga expressly identifies magnesium carbonate as a suitable diluent in pharmaceutical compositions containing pitolisant hydrochloride wherein the total weight of the diluent ranges from 20 to 90% (col. 4, lines 13-22). Raga also identifies other diluents such as microcrystalline cellulose and lactose, and lubricants such as magnesium stearate (col. 4, lines 13-22; col. 4, lines 39-43). Raga additionally teaches treatment of sleep disorders, sleep apnea, sleep induced apnea, and diurnal somnolence by administering the composition containing pitolisant hydrochloride and pharmaceutically acceptable diluents or carriers (col. 3, lines 1-19).
Bertelsen teaches pharmaceutical compositions in which an active drug ingredient is brought into contact with an alkaline substance with which Bertelsen identifies as sodium bicarbonate, sodium carbonate, magnesium carbonate, and magnesium hydroxide (col. 3, lines 59-67; col. 4, lines 35-44). Bertelsen further teaches the combination of active drug ingredient and alkaline substance results in a controlled, quick release of the active drug ingredient in vivo (col. 6, lines 3-30). Finally, Bertelsen teaches coated tablets as the preferred embodiment of the invention (col. 43, claim 18).
Regarding claim 1, Wakix teaches pitolisant hydrochloride tablets. Raga teaches combining pitolisant hydrochloride with magnesium carbonate and Bertelsen confirms that magnesium carbonate is an alkaline pharmaceutical substance capable of combination with an active pharmaceutical ingredient.
Therefore, the combined teachings render obvious a combination of a salt of pitolisant with an alkalinizing agent.
Regarding claim 2, Wakix and Raga expressly identify the pitolisant salt as pitolisant hydrochloride.
Regarding claim 3, Raga and Bertelsen identify magnesium carbonate as capable of formulation with an active pharmaceutical ingredient.
Regarding claims 4 and 19, Raga expressly identifies magnesium carbonate as a suitable diluent in pitolisant-HCl pharmaceutical compositions. Bertelsen further identifies magnesium carbonate as an alkaline substance suitable for contact with an active pharmaceutical ingredient in a coated tablet.
Regarding claim 5, Raga teaches magnesium carbonate in a total weight range of 20 to 90%. Bertelson further teaches bringing the alkalinizing agent into contact with the active pharmaceutical ingredient and adjusting the quantities to obtain the desired quick-release and local pH properties. Although the references do not express the relative quantities using the claimed formula, the claimed range of 5-99% is extremely broad and encompasses conventional formulations containing materially less alkalinizing agent than API, approximately equal quantities, and materially more alkalinizing agent than API.
Selection of the relative amounts would have constituted routine formulation optimization because the amount of magnesium carbonate was known in the art to affect dilution, tablet mass, local pH, dispersion, and release properties. The claimed range does not identify a critical point or narrow region apart from the known quantities previously disclosed in the art.
Raga teaches pitolisant-HCl unit doses of 20 mg and 40 mg in coated tablets having a total weight of 125 mg (col. 21 and 22, examples 14-17), which corresponds to 16 wt% and 32 wt% respectively. Raga further teaches magnesium carbonate as a suitable diluent in a range of 20-90 wt%. Applying the claimed ratio formula, Raga’s disclosed outer combinations provide ratios ranging from approximately 38% to 85%. This range falls entirely within the claimed range of 5-99%. Accordingly, the claimed ratio would have been obvious from Raga’s disclosed component amounts.
Regarding claim 6, Wakix teaches orally administering pitolisant-HCl to subjects in need of treatment for EDS and cataplexy associated with narcolepsy. Raga additionally teaches administering pitolisant-HCL to treat sleep disorders, sleep apnea, sleep induced apnea, and diurnal somnolence.
Modification of the administered Wakix tablet to include magnesium carbonate would not change pitolisant’s known therapeutic purpose.
Regarding claim 8, Wakix expressly teaches a pharmaceutical composition containing pitolisant-HCl and pharmaceutically acceptable excipients. Raga renders inclusion of magnesium carbonate obvious.
Regarding claim 9, Wakix teaches a pitolisant-HCl tablet.
Raga teaches pitolisant-HCl tablets containing magnesium carbonate at a total concentration of 20-90 wt%. That range overlaps with the claimed range of alkalinizing agent at 2 to 50 wt%. Raga further teaches pitolisant-HCl unit doses of 1-200 mg in conventional tablets. Selection of tablet mass and active ingredient content to provide 0.5-20 wt% pitolisant HCl would have been a routine dosage form calculation governed by the selected therapeutic dose, tablet size, compressibility, and excipient requirements.
Therefore, the claimed ranges would have been obvious results of routine formulation optimization, particularly because Applicant has not identified a criticality associated with the broadly claimed ranges.
Regarding claim 10, Wakix teaches a film-coated tablet containing pitolisant HCl and excipients in its core. The skilled artisan would understand Wakix’s teachings as a conventional film-coated tablet formulation whereby the API and tablet excipients are contained in the compressed core while the polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide form or contribute to the film coating.
Raga expressly teaches preparing pitolisant-HCl compositions by blending and compressing the Api with excipients and then coating the tablet. It would have been obvious to include magnesium carbonate in the compressed blend, which becomes the tablet core, before applying the film coating.
Regarding claim 11, Wakix and Raga expressly teach including pharmaceutically acceptable excipients in the pitolisant-HCl tablet core, including microcrystalline cellulose, disintegrants, lubricants, and glidants.
It would have been obvious to a person of ordinary skill in the pharmaceutical formulation art, before the effective filing date of the claimed invention, to modify the Wakix pitolisant-HCl tablet to include magnesium carbonate, as taught by Raga and Bertelsen.
Wakix teaches a marketed oral pitolisant-HCl tablet to treat EDS and cataplexy associated with narcolepsy. Raga concerns the same pitolisant-HCl API and expressly teaches magnesium carbonate as a suitable tablet diluent for pitolisant-HCl compositions. Bertelsen further teaches magnesium carbonate and sodium carbonate are conventional alkaline pharmaceutical ingredients that may be combined with an API in a tablet formulation to increase the local pH and promote quick release.
One of ordinary skill would have a reason to select magnesium carbonate from Raga’s expressly disclosed pitolisant-HCl excipients and incorporate it into the Wakix tablet core to perform its known functions as a pharmaceutical diluent, alkaline pH modifier, and quick-release/dispersing ingredient.
The combination would have involved using a known pharmaceutical ingredient, expressly taught as suitable for use with the same API by Raga, according to its established formulation functions. A skilled artisan would have reasonably expected magnesium carbonate to retain its known alkaline and tablet formulation properties when used with pitolisant-HCl.
Claims 7, 14-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Wakix (FDA Label, revised 10/2020), Raga (US Pat. No. 8,207,197 B2; date of patent: 26 June 2012), Bertelsen (US Pat. No. 8,231,899 B2; date of patent: 31 July 2012) as applied to claims 1-6, 8-11, and 19 above, and further in view of Nachiappan (US Pat. No. 9,693,978 B2; date of patent: 04 July 2017).
The teachings of Wakix, Raga, and Bertelsen are discussed above. While the combination of these references does not expressly teach the limitations of claims 7, 14-18, and 20, these limitations are made obvious in further view of Nachiappan.
Nachiappan teaches pharmaceutical compositions comprising a salt of an API and a deionizing agent (abstract). Nachiappan further teaches the deionizing agent causes partial deionization (neutralization) of the salt of the API resulting in enhanced bioavailability of salts weakly acidic, basic, or amphoteric active agents (abstract). Nachiappan identifies exemplary hydroxide ion species as deionizing agents include sodium hydroxide, potassium hydroxide, calcium hydroxide, aluminum hydroxide, and magnesium hydroxide (col. 4, lines 40-44).
Nachiappan teaches the deionizing agent functions by causing partial deionization of the API salt and when the API is a salt of a weak base and a strong acid, the deionizing agent is preferably a hydroxide ion species (col 4, lines 22-32). Nachiappan further teaches that the general inventive approach applied to drugs containing basic groups, including piperidinyl (col. 3, lines 17-24). Pitolisant contains a piperidinyl group and is administered in Wakix as the hydrochloride salt of a weak base.
Regarding claims 7, 14-18, and 20, the combination of the references renders obvious administering pitolisant-HCl with an alkalinizing agent to accelerate and/or increase absorption. Raga and Bertelson render the combination of pitolisant-HCl with an alkalinizing agent obvious. Furthermore, Bertelsen supplies the quick-release objective while Nachiappan supplies the enhanced bioavailability objective associated with a salt of an API. Therefore, one of ordinary skill would have a reasonable expectation that the formula would increase the rate or amount of absorption.
It would have been obvious to a person of ordinary skill in the pharmaceutical formulation art, before the effective filing date of the claimed invention, to use the alkaline agent taught by Raga and Bertelsen with pitolisant-HCl not only as a tablet excipient, but to raise local pH and partially neutralize or deionize the hydrochloride salt.
Nachiappan teaches the known pharmaceutical principle that partial neutralization of the salt of a weakly basic API by a hydroxide ion-producing agent can enhance bioavailability. Bertelsen teaches using magnesium carbonate, sodium carbonate, or magnesium hydroxide in solid tablets to create a local pH increase and quick release properties. Raga expressly identifies magnesium carbonate as suitable for compositions containing the same pitolisant-HCl API.
A skilled artisan would have reason to combine the teaches of Wakix, Raga, Bertelsen, and Nachiappan to obtain a pitolisant formulation having a modified release profile and accelerated absorption characteristics. The skilled artisan would reasonably have expected an alkaline microenvironment to partially neutralize pitolisant-HCl thereby affecting drug availability and membrane transport.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Wakix (FDA Label, revised 10/2020), Raga (US Pat. No. 8,207,197 B2; date of patent: 26 June 2012), Bertelsen (US Pat. No. 8,231,899 B2; date of patent: 31 July 2012) as applied to claims 1-6, 8-11, and 19 above, and further in view of Khanna (WO 2017/033107 A1; date of publication: 02 March 2017).
The teachings of Wakix, Raga, and Bertelsen are discussed above. While the combination of these references does not expressly teach the limitations of claim 12, these limitations are made obvious in further view of Khanna.
As previously discussed, Wakix teaches a coated tablet containing pitolisant-HCl, microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide. Raga teaches a pitolisant-HCl coated tablet containing magnesium carbonate as a diluent in a total amount of 20-90 wt%, microcrystalline cellulose and lactose as alternative or additional diluents, disintegrants between 2-5 wt%, lubricants up to 5 wt%, glidants between 0.1-1 wt%, and conventional film coating of the resulting tablet. Accordingly, the selection of 3-15 wt% pitolisant-HCl; 20-50 wt% magnesium carbonate; 35-50 wt% total excipients; and a conventional film coating of 2-5 wt% would have amounted to nothing more than routine optimization of known result-effective tablet formulation variables.
For the particular 2-5 wt% coating amount as recited in claim 12:
Rhanna teaches a direct compression tablet comprising Afatinib or a pharmaceutically acceptable salt thereof (abstract). Rhanna expressly teaches the tablet may be film coated and the film coating present in the range of 2-5 wt% (p. 36, claim 11).
It would have been obvious to a person of ordinary skill in the pharmaceutical formulation art, before the effective filing date of the claimed invention, to use the formulation parameters taught by Wikix, Raga, and Bertelsen with the conventional coating parameters taught by Rhanna to arrive at the currently claimed formulation in claim 12.
A skilled artisan would have applied Khanna’s conventional coating amount to Raga’s film-coated pitolisant-HCl tablet to obtain sufficient coverage while minimizing unnecessary tablet mass and manufacturing time.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Wakix (FDA Label, revised 10/2020), Raga (US Pat. No. 8,207,197 B2; date of patent: 26 June 2012), Bertelsen (US Pat. No. 8,231,899 B2; date of patent: 31 July 2012) as applied to claims 1-6, 8-11, and 19 above, and further in view of Ghosh (WO 2007/080601 A1; date of publication: 19 July 2007).
The teachings of Wakix, Raga, and Bertelsen are discussed above. While the combination of these references does not expressly teach the limitations of claim 13 these limitations are made obvious in further view of Ghosh.
As previously discussed, Wakix teaches a coated tablet containing pitolisant-HCl, microcrystalline cellulose, magnesium stearate, and colloidal silicon dioxide. Raga teaches a pitolisant-HCl coated tablet containing magnesium carbonate as a diluent in a total amount of 20-90 wt%, microcrystalline cellulose and lactose as alternative or additional diluents, disintegrants between 2-5 wt%, lubricants up to 5 wt%, glidants between 0.1-1 wt%, and conventional film coating of the resulting tablet. Accordingly, the selection of 0.5-20 wt% pitolisant-HCl; 2-20 wt% magnesium carbonate; 40-60 wt% total excipients; and a conventional film coating of 5-15 wt% gastro-resistant coating agents and 2-5 wt% plasticizers and coating systems would have amounted to nothing more than routine optimization of known result-effective tablet formulation variables.
For the particular gastro-resistant coating as recited in claim 13:
Ghosh teaches gastro-resistant oral pharmaceutical compositions comprising an API core and an enteric coating (abstract). Ghosh teaches:
An enteric layer that is soluble in intestinal fluid and resistant to gastric fluids to protect the API from acidic degradation while the dosage form transits the stomach (p. 11, lines 1-5);
An enteric layer that comprises enteric polymers, plasticizers, colorants, and flavoring agents (p. 11, lines 6-9);
The enteric polymer coating in an amount of 5-15 wt%;
The plasticizers in an amount of 1-5 wt%; and
Application of the gastro-resistant coating to a pharmaceutical core (p. 11, lines 1-5).
It would have been obvious to a person of ordinary skill in the pharmaceutical formulation art, before the effective filing date of the claimed invention, to select the enteric-polymer and plasticizer amounts of Ghosh to obtain adequate gastric resistance, coating integrity, and intestinal release while minimizing unnecessary coating mass. The prior art discloses conventional formulation ingredients at conventional formulation ranges. No criticality or unexpected results have been shown for the broadly claimed ranges. As such, the prior art teaches result-effective tablet formulation variables which are known to be routinely optimized through standard dissolution testing.
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.
Co-pending application no. 18/849,569
Claims 1-11 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 18/849,569 (reference application ‘569) and in further view of Raga (US Pat. No. 8,207,197 B2; date of patent: 26 June 2012) and Bertelsen (US Pat. No. 8,231,899 B2; date of patent: 31 July 2012).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the claims of ‘569 are drawn to a method comprising administration of a pitolisant hydrochloride.
The ‘569 claims are drawn to a method of treating severe fatigue comprising administering a dose of pitolisant. The difference between the ‘569 claims and the instantly claimed invention is that ‘569 claim 1 does not expressly require the pharmaceutically acceptable excipient be an alkalinizing agent. However, the modification of ‘569 to include an alkalinizing agent is made obvious in view of Raga and Bertelsen as previously discussed in the preceding rejection section. Furthermore, the method of using such a composition as claimed in ‘569 would render obvious the composition of the instantly claimed invention.
Therefore, the claims of ‘569 in further view of Raga and Bertelsen make obvious that which is instantly claimed in claims 1-11 and 14-20.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 12 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 18/849,569 (reference application ‘569) and in further view of Raga (US Pat. No. 8,207,197 B2; date of patent: 26 June 2012), Bertelsen (US Pat. No. 8,231,899 B2; date of patent: 31 July 2012), Khanna (WO 2017/033107 A1; date of publication: 02 March 2017), and Ghosh (WO 2007/080601 A1; date of publication: 19 July 2007).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the claims of ‘569 are drawn to a method comprising administration of a pitolisant hydrochloride.
The formulations of claims 12 and 13 are considered routine optimization of known pharmaceutical formulation variables at known formulation ranges as previously discussed in the preceding rejection section. Therefore, in view of the teachings of Raga, Bertelsen, Khanna, and Ghosh, it would be obvious to formulate the dosage form of ‘569 using previously disclosed formulation variables at previously disclosed formulation ranges as taught by the combined references.
Therefore, the claims of ‘569 in further view of Raga, Bertelsen, Khanna, and Ghosh make obvious that which is instantly claimed in claims 12-13.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending application no. 18/679,624
Claims 1-11 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 18/679,624 (reference application ‘624) and in further view of Raga (US Pat. No. 8,207,197 B2; date of patent: 26 June 2012) and Bertelsen (US Pat. No. 8,231,899 B2; date of patent: 31 July 2012).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the claims of ‘624 are drawn to a method comprising administration of a pitolisant hydrochloride.
The ‘624 claims are drawn to a method of treating EDS comprising administering a dose of pitolisant monohydrochloride. The difference between the ‘624 claims and the instantly claimed invention is that ‘624 claim 1 does not expressly require the pharmaceutically acceptable excipient be an alkalinizing agent. However, the modification of ‘624 to include an alkalinizing agent is made obvious in view of Raga and Bertelsen as previously discussed in the preceding rejection section. Furthermore, the method of using such a composition as claimed in ‘624 would render obvious the composition of the instantly claimed invention.
Therefore, the claims of ‘624 in further view of Raga and Bertelsen make obvious that which is instantly claimed in claims 1-11 and 14-20.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 12 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 18/679,624 (reference application ‘624) and in further view of Raga (US Pat. No. 8,207,197 B2; date of patent: 26 June 2012), Bertelsen (US Pat. No. 8,231,899 B2; date of patent: 31 July 2012), Khanna (WO 2017/033107 A1; date of publication: 02 March 2017), and Ghosh (WO 2007/080601 A1; date of publication: 19 July 2007).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the claims of ‘624 are drawn to a method comprising administration of a pitolisant hydrochloride.
The formulations of claims 12 and 13 are considered routine optimization of known pharmaceutical formulation variables at known formulation ranges as previously discussed in the preceding rejection section. Therefore, in view of the teachings of Raga, Bertelsen, Khanna, and Ghosh, it would be obvious to formulate the dosage form of ‘624 using previously disclosed formulation variables at previously disclosed formulation ranges as taught by the combined references.
Therefore, the claims of ‘624 in further view of Raga, Bertelsen, Khanna, and Ghosh make obvious that which is instantly claimed in claims 12-13.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending application no. 18/912,077
Claims 1-11 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-35 and 46-56 of copending Application No. 18/912,077 (reference application ‘077) and in further view of Raga (US Pat. No. 8,207,197 B2; date of patent: 26 June 2012) and Bertelsen (US Pat. No. 8,231,899 B2; date of patent: 31 July 2012).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the claims of ‘077 are drawn to a pharmaceutical composition comprising a pitolisant hydrochloride, a pharmaceutically acceptable excipient, and a method of using such to treat sleep disorder.
The ‘077 claims are drawn to a composition and method comprising a Form II polymorph of pitolisant hydrochloride. The difference between the ‘077 claims and the instantly claimed invention is that ‘077 claim 25 does not expressly require the pharmaceutically acceptable excipient be an alkalinizing agent. However, the modification of ‘077 to include an alkalinizing agent is made obvious in view of Raga and Bertelsen as previously discussed in the preceding rejection section.
Therefore, the claims of ‘077 in further view of Raga and Bertelsen make obvious that which is instantly claimed in claims 1-11 and 14-20.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 12 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-35 and 46-56 of copending Application No. 18/912,077 (reference application ‘077) and in further view of Raga (US Pat. No. 8,207,197 B2; date of patent: 26 June 2012), Bertelsen (US Pat. No. 8,231,899 B2; date of patent: 31 July 2012), Khanna (WO 2017/033107 A1; date of publication: 02 March 2017), and Ghosh (WO 2007/080601 A1; date of publication: 19 July 2007).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the claims of ‘077 are drawn to a pharmaceutical composition comprising a pitolisant hydrochloride, a pharmaceutically acceptable excipient, and a method of using such to treat sleep disorder.
The formulations of claims 12 and 13 are considered routine optimization of known pharmaceutical formulation variables at known formulation ranges as previously discussed in the preceding rejection section. Therefore, in view of the teachings of Raga, Bertelsen, Khanna, and Ghosh, it would be obvious to formulate the dosage form of ‘077 using previously disclosed formulation variables at previously disclosed formulation ranges as taught by the combined references.
Therefore, the claims of ‘077 in further view of Raga, Bertelsen, Khanna, and Ghosh make obvious that which is instantly claimed in claims 12-13.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending application no. 18/917,144
Claims 1-11 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-48 of copending Application No. 18/817,144 (reference application ‘144).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the claims of ‘144 are drawn to a composition containing pitolisant-HCl and an alkalinizing agent and a method of use.
Instant Application Claim No.
‘144 Claim No.
Drawn to
1, 2
1, 2
Combination of pitolisant-HCl w/ an alkalinizing agent
3, 4, 19
3
Alkalinizing agent is magnesium carbonate or sodium carbonate
5, 9
12, 38
Formulation variables
(further evidenced by Raga)
6
35
Method of treatment
7, 14-18, and 20
24, 25
Bioavailability of pitolisant
8-11
38
Formulation variables
Therefore, the claims of ‘144 anticipate that which is claimed in instant claims 1-11 and 14-20.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 12 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-48 of copending Application No. 18/817,144 (reference application ‘144) and in further view of Raga (US Pat. No. 8,207,197 B2; date of patent: 26 June 2012), Khanna (WO 2017/033107 A1; date of publication: 02 March 2017), and Ghosh (WO 2007/080601 A1; date of publication: 19 July 2007).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the claims of ‘144 are drawn to a composition containing pitolisant-HCl and an alkalinizing agent and a method of use.
The formulations of claims 12 and 13 are considered routine optimization of known pharmaceutical formulation variables at known formulation ranges as previously discussed. Therefore, in view of the teachings of Raga, Khanna, and Ghosh, it would be obvious to formulate the oral dosage form of ‘144 using previously disclosed formulation variables at previously disclosed formulation ranges as taught by the combined references.
Therefore, the claims of ‘144 in further view of Raga, Khanna, and Ghosh make obvious that which is instantly claimed in claims 12-13.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Co-pending application no. 19/355,702
Claims 1-11 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-7, 10-13, 16, 23, 27-32, 44-45, 58-64, and 67 of copending Application No. 19/355,702 (reference application ‘702) and in further view of Raga (US Pat. No. 8,207,197 B2; date of patent: 26 June 2012) and Bertelsen (US Pat. No. 8,231,899 B2; date of patent: 31 July 2012).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the claims of ‘702 are drawn to a composition containing pitolisant-HCl and method of use.
The ‘702 claims are drawn to an oral dosage form of pitolisant monohydrochloride, a pharmaceutically acceptable excipient, and a method of treating a sleep disorder using such. The difference between the ‘702 claims and the instantly claimed invention is that ‘702 claim 1 does not expressly require the pharmaceutically acceptable excipient be an alkalinizing agent. However, the modification of ‘702 to include an alkalinizing agent is made obvious in view of Raga and Bertelsen as previously discussed in the preceding rejection section.
Therefore, the claims of ‘702 in further view of Raga and Bertelsen make obvious that which is instantly claimed in claims 1-11 and 14-20.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 12 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-7, 10-13, 16, 23, 27-32, 44-45, 58-64, and 67 of copending Application No. 19/355,702 (reference application ‘702) and in further view of Raga (US Pat. No. 8,207,197 B2; date of patent: 26 June 2012), Bertelsen (US Pat. No. 8,231,899 B2; date of patent: 31 July 2012), Khanna (WO 2017/033107 A1; date of publication: 02 March 2017), and Ghosh (WO 2007/080601 A1; date of publication: 19 July 2007).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the claims of ‘702 are drawn to a composition containing pitolisant-HCl and a method of use.
The formulations of claims 12 and 13 are considered routine optimization of known pharmaceutical formulation variables at known formulation ranges as previously discussed in the preceding rejection section. Therefore, in view of the teachings of Raga, Bertelsen, Khanna, and Ghosh, it would be obvious to formulate the tablet dosage form of ‘702 using previously disclosed formulation variables at previously disclosed formulation ranges as taught by the combined references.
Therefore, the claims of ‘702 in further view of Raga, Bertelsen, Khanna, and Ghosh make obvious that which is instantly claimed in claims 12-13.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
US Pat. No. 11,179,329 B2
Claims 1-11 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of US Pat. No. 11,179,329 B2 (‘329) and in further view of Raga (US Pat. No. 8,207,197 B2; date of patent: 26 June 2012) and Bertelsen (US Pat. No. 8,231,899 B2; date of patent: 31 July 2012).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the claims of ‘329 are drawn to a method of treating sleep disorders by administering a composition containing pitolisant-HCl.
The ‘329 claims are drawn to administering a composition comprising pitolisant-HCl. The difference between the ‘329 claims and the instantly claimed invention is that ‘329 claim 1 does not expressly require a pharmaceutically acceptable excipient and that pharmaceutically acceptable excipient is an alkalinizing agent. However, the modification of ‘329 to include an alkalinizing agent is made obvious in view of Raga and Bertelsen as previously discussed in the preceding rejection section. Raga further makes obvious the use of pitolisant monohydrochloride to treat sleep disorders.
Therefore, the claims of ‘329 in further view of Raga and Bertelsen make obvious that which is instantly claimed in claims 1-11 and 14-20.
Claims 12 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of US Pat. No. 11,179,329 B2 (‘329) and in further view of Raga (US Pat. No. 8,207,197 B2; date of patent: 26 June 2012), Bertelsen (US Pat. No. 8,231,899 B2; date of patent: 31 July 2012), Khanna (WO 2017/033107 A1; date of publication: 02 March 2017), and Ghosh (WO 2007/080601 A1; date of publication: 19 July 2007).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the claims of ‘329 are drawn to a composition containing pitolisant-HCl.
The formulations of claims 12 and 13 are considered routine optimization of known pharmaceutical formulation variables at known formulation ranges as previously discussed in the preceding rejection section. Therefore, in view of the teachings of Raga, Bertelsen, Khanna, and Ghosh, it would be obvious to formulate the dosage form of ‘329 using previously disclosed formulation variables at previously disclosed formulation ranges as taught by the combined references.
Therefore, the claims of ‘329 in further view of Raga, Bertelsen, Khanna, and Ghosh make obvious that which is instantly claimed in claims 12-13.
US Pat. No. 12,145,916 B2
Claims 1-11 and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of US Pat. No. 12,145,916 B2 (‘916) and in further view of Raga (US Pat. No. 8,207,197 B2; date of patent: 26 June 2012) and Bertelsen (US Pat. No. 8,231,899 B2; date of patent: 31 July 2012).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the claims of ‘916 are drawn to a composition containing pitolisant-HCl.
The ‘916 claims are drawn to a pharmaceutical composition comprising pitolisant monohydrochloride and a pharmaceutically acceptable excipient. The difference between the ‘916 claims and the instantly claimed invention is that ‘916 claim 11 does not expressly require the pharmaceutically acceptable excipient be an alkalinizing agent. However, the modification of ‘916 to include an alkalinizing agent is made obvious in view of Raga and Bertelsen as previously discussed in the preceding rejection section. Raga further makes obvious the use of pitolisant monohydrochloride to treat sleep disorders.
Therefore, the claims of ‘916 in further view of Raga and Bertelsen make obvious that which is instantly claimed in claims 1-11 and 14-20.
Claims 12 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of US Pat. No. 12,145,916 B2 (‘916) and in further view of Raga (US Pat. No. 8,207,197 B2; date of patent: 26 June 2012), Bertelsen (US Pat. No. 8,231,899 B2; date of patent: 31 July 2012), Khanna (WO 2017/033107 A1; date of publication: 02 March 2017), and Ghosh (WO 2007/080601 A1; date of publication: 19 July 2007).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the claims of ‘916 are drawn to a composition containing pitolisant-HCl.
The formulations of claims 12 and 13 are considered routine optimization of known pharmaceutical formulation variables at known formulation ranges as previously discussed in the preceding rejection section. Therefore, in view of the teachings of Raga, Bertelsen, Khanna, and Ghosh, it would be obvious to formulate the tablet dosage form of ‘916 using previously disclosed formulation variables at previously disclosed formulation ranges as taught by the combined references.
Therefore, the claims of ‘916 in further view of Raga, Bertelsen, Khanna, and Ghosh make obvious that which is instantly claimed in claims 12-13.
Conclusion
Claims 1-20 are rejected. No claim is allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Julia A. Rossi whose telephone number is (571)272-0138. The examiner can normally be reached M-Th 7:30-5:30 (MST).
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/JULIA A. ROSSI/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
1 See Calik, “Update on the treatment of narcolepsy: clinical efficacy of pitolisant” (published 2017).
