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 .
Status of the Claims
Claims 1-21 are currently pending and under examination.
Priority
The instant application 18/934,671 filed on November 1, 2024 claims priority to, and the benefits of U.S. Provisional Application No. 63/595,300 filed on November 1, 2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/09/2025, 02/20/2025, 11/04/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 11, 14, 17, 19, and 21 are objected to because of the following informalities:
In claim 11, “Then method” should be changed to the method.
In claim 14, “a EQ-5D-5L score” should be changed to an EQ-5D-5L score. A comma should also be inserted before the final “or any combination thereof.”
In claim 17, “the additional, additional therapeutically effective amount” should be corrected by deleting the repeated word “additional.”
In claim 19, the phrase “treatment of pain treatment of pain” is repeated twice and should be corrected. The phrase “the minimum effective level of therapeutically effective amount” also should be revised into a grammatically complete expression, such as the minimum therapeutically effective amount.
In claim 21, the phrase “administration of the therapeutically effective amount … administered is discontinued” is redundant and should be revised, for example, to recite that administration of the therapeutically effective amount … is discontinued.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “treatment of pain associated with trigeminal neuralgia” in the preamble while the same claims recite “thereby treating trigeminal neuralgia in the patient.” Those concepts are not necessarily identical. Treating TN-associated pain does not necessarily mean treating the underlying TN disease/pathology. These disclosures do not resolve which scope is required by claim 1. Claims 2-21 depend directly or indirectly from claim 1 and inherit this ambiguity.
Claim 16 requires administration “about every 12 hours,” while dependent claim 17 requires the amount to be increased “about every 30 minutes to 5 hours.” The specification discloses embodiments in which an additional dose is administered about 30 minutes to about 5 hours following the initial dose, including examples in which an initial 0.5 mg dose is followed by a 1 mg dose about 30 minutes later and an initial 1 mg dose is followed by a 2.5 mg dose about 2 hours later. The specification, however, does not clarify how the approximately 30-minute-to-5-hour dose-increase limitation of claim 17 is to operate together with the approximately 12-hour administration interval inherited from claim 16. Accordingly, it remains unclear whether claim 17 changes the administration interval required by claim 16, requires the dose amount somehow to be increased during the 30-minute-to-5-hour period while administration remains approximately every 12 hours, or requires some other dosing regimen.
Claims 18 and 19 are indefinite because they depend from indefinite claim 17.
Claim 19 is additionally indefinite because “the minimum effective level of therapeutically effective amount” does not identify with reasonable certainty whether the claim refers to a dose amount, a plasma concentration, a dosing frequency, or another treatment parameter. The repeated phrase “treatment of pain treatment of pain” further obscures the intended scope.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, 5, 7-10, and 15 are rejected under 35 U.S.C. §103 as being unpatentable over Pricolo (WO 2016/127221 A1).
Regarding claim 1, Pricolo teaches methods and pharmaceutical compositions for treating pain by administering an analgesic together with a sedating antihistamine (see e.g., p. 4, line 6). Pricolo expressly identifies neuropathic pain and trigeminal neuralgia as pain conditions to be treated (see e.g., p. 19, line 5). Pricolo also identifies trimeprazine as a sedating antihistamine suitable for use in the disclosed pain-treatment methods and expressly discloses approximately 2.5-25 mg of trimeprazine per unit dose (see e.g., p. 13, line 15). Although Pricolo administers the sedating antihistamine together with an analgesic, claim 1 uses the open transitional term “comprising” and therefore does not exclude administration of an additional analgesic.
Pricolo does not expressly exemplify the particular selection of trimeprazine for a patient having trigeminal neuralgia. However, Pricolo identifies both trimeprazine as an antihistamine for its pain-treatment regimen and trigeminal neuralgia as a neuropathic pain condition to which that regimen is applicable.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select trimeprazine from Pricolo’s expressly disclosed sedating antihistamines for treating the expressly identified pain associated with trigeminal neuralgia. Such a selection would have involved use of a disclosed active agent for a disclosed pain indication according to Pricolo’s express teachings. One of ordinary skill would have reasonably expected the treatment to provide symptomatic relief from trigeminal-neuralgia pain because Pricolo expressly teaches use of the sedating antihistamine-containing regimen to reduce or ameliorate neuropathic pain, including trigeminal neuralgia
Regarding claims 4 and 5, Pricolo teaches orally administered solid dosage units, including tablets and capsules contraindicated (see e.g., p. 23, line 27). Because claim 4 recites alternative routes in the disjunctive, Pricolo’s oral administration satisfies the claimed route alternative.
Regarding claim 7, Pricolo’s 2.5-25 mg trimeprazine range is contained within the claimed range of about 0.5-80 mg (see e.g., p. 13, line 15).
Regarding claim 8, Pricolo expressly discloses both 2.5 mg and 5 mg amounts within the claimed range of about 2.5-5 mg (see e.g., p. 13, line 15).
Regarding claim 9, Pricolo expressly discloses 2.5 mg, which is the upper endpoint of the claimed range of about 0.5-2.5 mg. Selection of that expressly disclosed dose would have been obvious (see e.g., p. 13, line 15).
Regarding claim 10, Pricolo defines treatment as reducing or ameliorating the severity, incidence, progression, or duration of pain (see e.g., p. 22, line 5). Thus, Pricolo teaches reducing the intensity, frequency, or duration of pain.
Regarding claim 15, Pricolo teaches administering trimeprazine in unit doses beginning at about 2.5 mg, with the disclosed range extending to about 25 mg. Pricolo does not expressly identify a dose within about 2.5 mg to about 5 mg as the “initial dose.” However, every treatment regimen necessarily begins with a first administered dose, and the lower portion of Pricolo’s expressly disclosed trimeprazine dosage range overlaps the claimed 2.5–5 mg initial-dose range. It would have been obvious to begin treatment with a dose at the lower end of the disclosed range, such as about 2.5–5 mg, in order to assess therapeutic response while limiting unnecessary exposure to the known sedating antihistamine.
Accordingly, claims 1, 4, 5, and 7-10 are unpatentable over Pricolo.
Claims 1 and 2 are rejected under 35 U.S.C. § 103 as being unpatentable over Pricolo in view of THERALENE (5 mg, pharmaciebechieau, ANSM, updated June 10, 2021).
Pricolo teaches treatment of pain, including pain associated with trigeminal neuralgia, using a regimen comprising trimeprazine as discussed above. Pricolo further teaches administration of a sedating-antihistamine-containing dosage unit at a time when sedation or sleep is desirable or not contraindicated.
Pricolo does not expressly teach administration of trimeprazine once daily.
THERALENE teaches alimemazine. Alimemazine and trimeprazine are names for the same active substance; FDA GSRS identifies “ALIMEMAZINE” as a synonym of “TRIMEPRAZINE.”
THERALENE expressly instructs that alimemazine/trimeprazine is “Take once a day in the evening, 15 to 30 minutes before bedtime”. THERALENE teaches an adult dose of 5–10 mg, exceptionally up to 20 mg (THERALENE, § 4.2, Dosage and method of administration).
It would have been obvious to one of ordinary skill in the art before the effective filing date to administer Pricolo’s trimeprazine-containing treatment once daily according to the known once-daily dosing schedule taught for the same drug by THERALENE. Pricolo expressly contemplates administration of the sedating antihistamine when sedation or sleep is desirable, and THERALENE establishes that trimeprazine itself may suitably be administered as a single daily evening dose. The modification therefore would have been a predictable use of a known dosage frequency for the same active agent, with a reasonable expectation of successful administration.
Accordingly, claims 1 and 2 are unpatentable over Pricolo in view of THERALENE.
Claims 1 and 3 are rejected under 35 U.S.C. § 103 as being unpatentable over Pricolo in view of Carbamazepine (the carbamazepine prescribing information, revised 2013).
Pricolo teaches treatment of pain associated with trigeminal neuralgia using a regimen comprising trimeprazine as discussed above but does not expressly teach administering trimeprazine twice daily.
Carbamazepine specifically teaches pharmacological treatment of trigeminal neuralgia. Under “Dosage and Administration—Trigeminal Neuralgia,” the prescribing information teaches an initial tablet regimen of 100 mg twice daily for a total daily dose of 200 mg.
It would have been obvious to one of ordinary skill in the art before the effective filing date to administer Pricolo’s trimeprazine-containing trigeminal-neuralgia treatment twice daily according to the established twice-daily pharmacological dosing practice for the same pain condition taught by Carbamazepine. One of ordinary skill would have been motivated to use divided dosing to maintain treatment of the recurrent TN pain condition and would have reasonably expected success because twice-daily administration was an established dosing regimen for drug treatment of trigeminal neuralgia.
Accordingly, claims 1 and 3 are unpatentable over Pricolo in view of the Carbamazepine prescribing information.
Claims 1 and 6 are rejected under 35 U.S.C. § 103 as being unpatentable over Pricolo in view of Paiement et al. (US 2019/0231685 A1).
Pricolo teaches oral administration of trimeprazine as a sedating antihistamine for treating pain, including trigeminal-neuralgia pain, but does not expressly teach administering trimeprazine in an oral thin-film formulation.
Paiement et al. teach oral thin-film dosage forms containing safe and therapeutically effective amounts of antihistamines [0002]. Paiement et al. teach that the film may be configured for oral, buccal, transmucosal, or sublingual delivery [0018] and explain that oral films may improve ease of administration and provide oral or transmucosal delivery [0022]. Paiement et al. expressly include promethazine among the antihistamines suitable for the disclosed film and encompass other active agents having comparable antihistamine effects [0036].
It would have been obvious to one of ordinary skill in the art before the effective filing date to formulate Pricolo’s trimeprazine in the oral-film dosage form taught by Paiement et al. Pricolo identifies trimeprazine as a sedating antihistamine, while Paiement et al. teach oral-film delivery as a useful delivery platform for antihistamines, including a phenothiazine antihistamine such as promethazine. The modification would have predictably provided an alternative oral dosage form having the known administration advantages of an oral thin film, with a reasonable expectation of successfully delivering the antihistamine.
Accordingly, claims 1 and 6 are unpatentable over Pricolo in view of Paiement et al.
Claims 1, and 10-14 are rejected under 35 U.S.C. § 103 as being unpatentable over Pricolo in view of Symonds et al. (Journal of Pain Research, 2018 11:1067-1073).
Pricolo teaches treatment of trigeminal-neuralgia pain and teaches reducing the severity, incidence, and duration of pain as discussed above. Pricolo does not expressly describe the claimed reductions in terms of individual TN episodes or a series of at least two separate TN episodes, does not expressly characterize the pain using the particular manifestations recited in claim 13, and does not identify the Penn Facial Pain Scale-Revised.
Symonds et al. describe trigeminal neuralgia as an episodic facial-pain disorder and identify TN as involving sudden, severe, brief, stabbing, recurrent episodes of pain. Symonds et al. further develop the Penn Facial Pain Scale-Revised (Penn-FPS-R), a twelve-item outcome measure for assessing and monitoring the impact of trigeminal-neuralgia treatment interventions (see, e.g., p. 1067, Introduction, Results, and Conclusion).
Regarding claim 10, Pricolo teaches reduction in the severity, incidence, and duration of pain, corresponding to reduction in intensity, frequency, and duration, respectively.
Regarding claim 11, Symonds et al. establish that TN manifests as discrete, brief, recurrent episodes. It would therefore have been obvious to assess Pricolo’s disclosed reduction in duration with respect to the duration of an individual episode and/or a series of such episodes because those episodes are the known clinical manifestation of the condition being treated.
Regarding claim 12, Symonds et al. characterize the TN pain episodes as recurrent. A recurrent series encompasses at least two separate episodes. Thus, evaluating Pricolo’s reduction in pain duration over a series containing at least two separate TN episodes would have been a predictable clinical assessment of treatment response.
Regarding claim 13, Symonds et al. expressly identify TN as involving “stabbing” episodes of pain. Claim 13 encompasses stabbing pain among the recited pain manifestations. Application of Pricolo’s treatment to a patient presenting with stabbing TN pain therefore would have been obvious because Symonds et al. establish stabbing pain as a recognized manifestation of the same condition.
Regarding claim 14, Symonds et al. expressly teach the Penn-FPS-R as an outcome measure for assessing and monitoring the impact of TN treatment interventions. Because claim 14 recites the listed measurement methods in the alternative, use of the Penn-FPS-R satisfies the claimed measurement limitation.
It would have been obvious to one of ordinary skill in the art before the effective filing date to apply the known episodic characterization and TN-specific assessment method taught by Symonds et al. when administering and evaluating Pricolo’s trigeminal-neuralgia pain treatment. The skilled artisan would have been motivated to evaluate therapeutic response according to the recognized episodic manifestations of the condition and using a validated TN-specific outcome instrument, with a reasonable expectation that doing so would reliably assess whether the treatment reduced the patient's TN pain.
Accordingly, claims 1 and 10–14 are unpatentable over Pricolo in view of Symonds et al.
Claims 1, 3, 15, 16, 20, and 21 are rejected under 35 U.S.C. § 103 as being unpatentable over Pricolo in view of Carbamazepine (the carbamazepine prescribing information, revised 2013).
Pricolo teaches treatment of pain associated with trigeminal neuralgia using a regimen comprising trimeprazine and teaches approximately 2.5–25 mg trimeprazine per unit dose, as discussed above. Pricolo therefore teaches a dosage range overlapping the claimed 2.5–5 mg initial dose of claim 15.
Pricolo does not expressly teach administering an additional trimeprazine amount about every 12 hours conditioned upon a determination that treatment of the pain has not been achieved, decreasing the dose to the minimum effective level at least about every three months, or discontinuing administration at least about every three months.
Carbamazepine teaches a response-guided dosing regimen specifically for trigeminal neuralgia. It teaches:
an initial dose of 100 mg twice daily;
increasing the daily dose by up to 200 mg/day using increments of 100 mg every 12 hours only as needed to achieve freedom from pain;
maintaining pain control at an effective dose, with some patients requiring substantially lower maintenance amounts; and
at least once every three months throughout the treatment period, making attempts to reduce the dose to the minimum effective level or even discontinue the drug.
Regarding claim 15, Pricolo’s disclosed trimeprazine range overlaps the claimed 2.5–5 mg range. It would have been obvious to use an amount within that lower overlapping portion as the first dose of treatment, particularly where Pricolo teaches that patient dosage and timing may be adjusted according to patient-specific factors.
Regarding claim 16, Carbamazepine does not merely teach arbitrary repeat dosing. It expressly conditions the additional dose increase on the patient's therapeutic response: an increase is made every 12 hours only as needed to achieve freedom from pain. Thus, the reference establishes the claimed conditional relationship—when the desired pain treatment has not yet been achieved, an additional amount is administered at approximately 12-hour intervals. Applying that established TN response-guided dosing procedure to Pricolo’s trimeprazine treatment would have rendered claim 16 obvious.
Regarding claim 20, Carbamazepine expressly teaches the claimed frequency and treatment condition. At least once every three months throughout treatment, the clinician is instructed to attempt to reduce the dose to the minimum effective level. Thus, rather than merely teaching generally that lower doses are desirable, Carbamazepine expressly identifies both the at-least-once-every-three-months interval and reduction to the minimum effective level recited by claim 20. In a patient whose pain remains controlled as the dose is reduced, carrying out the expressly recommended reduction results in the claimed decrease to the minimum effective amount.
Regarding claim 21, Carbamazepine likewise expressly identifies the claimed frequency and expressly presents discontinuation as one of the recommended TN dose-management alternatives: at least once every three months throughout treatment, an attempt should be made to reduce the dose to the minimum effective level or even discontinue the drug.
The rejection does not rely on the proposition that every attempt at discontinuation necessarily succeeds. Rather, Carbamazepine expressly instructs the clinician at the claimed interval to pursue discontinuation as a treatment-management option. For a patient in whom withdrawal is clinically successful, carrying out that expressly recommended option results in cessation of administration as required by claim 21. Claim 21 does not require that discontinuation be permanent, that every TN patient successfully discontinue treatment, or that treatment never subsequently be restarted. Thus, selection and performance of the expressly recommended discontinuation alternative in an appropriate patient would have been an obvious implementation of Carbamazepine’s TN treatment instructions.
It would have been obvious to one of ordinary skill in the art before the effective filing date to apply Carbamazepine’s established response-guided trigeminal-neuralgia dose-management procedure to Pricolo’s trimeprazine treatment. Both references concern pharmacological management of trigeminal-neuralgia pain. The skilled artisan would have been motivated to begin with a relatively low trimeprazine dose, administer an additional dose when pain control had not been achieved, maintain only the amount necessary for pain control, and periodically reduce or discontinue medication so as to obtain adequate pain relief while avoiding unnecessarily high or prolonged drug exposure. One of ordinary skill would have had a reasonable expectation of success because Carbamazepine expressly teaches these response-guided procedures for the same clinical condition.
Accordingly, claims 1, 3, 15, 16, 20, and 21 are unpatentable over Pricolo in view of the Carbamazepine prescribing information.
Claims 1 and 15-19 are rejected under 35 U.S.C. §103 as being unpatentable over Pricolo in view of Carbamazepine, and further in view of Rosen et al. (Journal of Pharmacy and Pharmacology, 1960, 12(Suppl.):237T–244T).
Pricolo teaches treating pain, including pain associated with trigeminal neuralgia, using a regimen comprising trimeprazine and teaches approximately 2.5–25 mg trimeprazine per unit dose.
Pricolo does not expressly teach the response-dependent escalation procedure of claims 16–19 or an increased subsequent amount administered within the approximately 30-minute-to-5-hour interval of claim 17.
Carbamazepine teaches a response-guided regimen specifically for trigeminal neuralgia. It teaches increasing the administered dose in defined increments every 12 hours only as needed to achieve freedom from pain. Once pain control is obtained, the patient is maintained at an effective level, Carbamazepine expressly directs periodic reduction toward the minimum effective level.
Thus, Carbamazepine expressly establishes that dose amount is increased according to whether TN pain remains uncontrolled, that escalation continues as needed until freedom from pain is achieved, and that following successful pain control treatment is maintained at the lowest effective level.
Carbamazepine does not teach a trimeprazine-specific administration interval within about 30 minutes to 5 hours.
Rosen et al. directly teaches human oral administration of trimeprazine itself. Rosen et al. administer 5 mg oral doses of non-sustained-release trimeprazine at time 0, 4 hours, and 8 hours (see e.g., p. 237T, abstract). Thus, Rosen et al. demonstrates actual repeated human administration of trimeprazine at a 4-hour interval, which falls within claim 17’s approximately 30-minute-to-5-hour interval. Rosen et al. further teaches a first 5 mg trimeprazine dose, which falls within claim 15’s claimed initial-dose range.
Regarding claim 15, Rosen et al. teaches an initial 5 mg oral trimeprazine dose at time zero, expressly falling within the claimed 2.5–5 mg initial dose.
Regarding claim 16, Carbamazepine expressly teaches that an additional dose increase is made at 12-hour intervals only as needed to achieve freedom from pain. Thus, the additional dosing is directly conditioned upon failure to achieve the desired pain-control result.
Regarding claim 17, claim 17 is separately rejected under 35 U.S.C. § 112(b). For purposes of prior-art examination, claim 17 is reasonably interpreted as requiring an increase in a subsequent trimeprazine amount at an interval falling within about 30 minutes to 5 hours while pain remains uncontrolled, with dose escalation continuing until treatment is achieved.
Carbamazepine teaches the increase in amount and the condition for continued escalation—the dose is increased only as needed until freedom from TN pain is achieved. Rosen et al. teaches that trimeprazine itself may be repeatedly administered to humans at 4-hour intervals. Thus, Carbamazepine supplies the response-guided dose-escalation principle, while Rosen et al. supply a trimeprazine-specific repeat-administration interval squarely within the claimed range.
Regarding claim 18, Carbamazepine teaches that once pain control is obtained, treatment is maintained at an effective amount and further instructs that dose reduction should be attempted to reach the minimum effective level. Thus, maintaining the trimeprazine amount that successfully provides pain control at the minimum effective level would have been a predictable application of Carbamazepine’s express TN maintenance-dose principle.
Regarding claim 19, Carbamazepine expressly conditions upward dose adjustment on lack of freedom from pain and teaches maintaining the dose once pain control is obtained. Therefore, if pain subsequently recurs while a patient is receiving the minimum effective maintenance amount, the patient again satisfies the same expressly taught condition—lack of freedom from pain—that triggers dose escalation. Reapplying Carbamazepine’s expressly taught response-guided titration until freedom from pain is again obtained would have been a predictable continuation of the same dosing procedure. Claim 19 additionally states that the amount “may be further increased,” making the subsequent increase permissive rather than an absolute requirement in every patient.
It would have been obvious to one of ordinary skill in the art before the effective filing date to apply Carbamazepine’s response-guided TN titration procedure to Pricolo’s trimeprazine treatment using the known trimeprazine dosage and administration interval demonstrated by Rosen et al. Pricolo and Carbamazepine address treatment of TN pain, Carbamazepine establishes that the amount should be increased according to whether pain control has been achieved, and Rosen et al. teaches that trimeprazine was successfully administered to humans in 5 mg doses at four-hour intervals. A skilled artisan therefore would have been motivated to use the known trimeprazine four-hour interval while adjusting the amount according to the patient's TN pain response, in order to obtain pain control without unnecessarily delaying reassessment or administering more drug than required. The skilled artisan would have had a reasonable expectation of success because each component of the resulting regimen—trimeprazine administration, response-guided TN dose escalation, and four-hour repeat administration of trimeprazine—was known in the prior art.
Accordingly, claims 1 and 15–19 are unpatentable over Pricolo in view of the Carbamazepine prescribing information and further in view of Rosen et al.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10, 13-16, 20, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending U.S. Application No. 18/862,220, published as US 2025/0288591 A1, alone or in view of Paiement et al., Symonds et al., Pricolo, and the carbamazepine prescribing information as applicable.
Claims 1-5 of the reference application claim the same central method of administering trimeprazine to treat trigeminal neuralgia, including once-daily administration, twice-daily administration, the same broad group of administration routes, and oral administration.
Reference claim 6 recites sublingual administration. Reference claims 7 and 8 recite about 0.5-20 mg and about 5 mg, respectively. Reference claims 11-15 recite reducing pain and measuring treatment using Penn-FPS-R, Penn-FPS, PGIC, EQ-5D-5L, and WPAI scores. Reference claim 16 recites the same basic method of reducing pain from trigeminal neuralgia by administering trimeprazine.
The instant claims differ principally by reciting:
a pharmaceutically acceptable salt;
an oral thin-film embodiment;
overlapping or adjoining dose ranges;
particular descriptions of known TN pain;
particular expressions of pain reduction;
a 2.5-5 mg initial amount;
response-guided approximately 12-hour administration; and
periodic reduction or discontinuation approximately every three months.
These differences do not render the instant claims patentably distinct. Pharmaceutically acceptable salts are conventional forms of trimeprazine. The oral thin film would have been obvious in view of Paiement et al.. The claimed dosage ranges overlap the reference claims’ approximately 0.5-20 mg and 5 mg doses and Pricolo’s 2.5-25 mg dose. The pain descriptions and measurement methods are conventional TN characteristics and assessments, as shown by Symonds. The initial dose, approximately 12-hour dosing, and three-month dose-reduction or discontinuation procedures would have been obvious in view of the conventional trigeminal-neuralgia dosing procedure in the carbamazepine label.
The reference claims and the instant claims therefore are not patentably distinct because the instant claims merely recite obvious dosage, formulation, measurement, and dose-management variations of the same trimeprazine treatment for trigeminal neuralgia.
This rejection is provisional because the reference application has not been confirmed as an issued patent. A provisional nonstatutory double-patenting rejection may be overcome by establishing patentable distinctness or by filing a complaint terminal disclaimer, subject to the applicable common-ownership and other requirements.
Conclusion
No claims are allowed.
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/G.S./ Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628
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