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 .
Priority
This application, filed 07/28/2023 is a National Stage entry of PCT/EP2022/052142, International Filing Date: 01/28/2022. PCT/EP2022/052142 claims foreign priority to 2101291.9, filed 01/29/2021; foreign priority to 2101292.7, filed 01/29/2021; and foreign priority to 2101296.8, filed 01/29/2021. Certified copies of the foreign priority applications are of record.
Status of Claims
Claims 1-14, 17, and 19 are pending as of the response filed on 2/10/26. Claims 15-16 and 18 have been canceled. The amendments to the specification to address a typographical error, filed on 12/16/25, is acknowledged and accepted.
Applicant’s election without traverse of invention II, claims 1-14 and 19 in the reply filed on 12/16/25 is acknowledged.
Claim 17 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/16/25.
Claims 1-14 and 19 were examined and are rejected.
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.
Claim(s) 1 and 5-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoyle et. al., US 20110136793 A1, publ. 6/9/2011, cited in an IDS.
Hoyle teaches a method of ameliorating drug-induced elevations in blood pressure by the adjunctive use of antihypertensive drugs (title & abstract). Hoyle teaches patients treated with CNS stimulants, including those patients with attention deficit hyperactivity disorder (ADHD) are at risk for developing hypertension; to overcome this adverse effect, patients are concurrently treated with antihypertensive agents, particularly calcium channel blockers (abstract; para [0002], [0030]). Hoyle exemplifies amlodipine as a calcium channel blocker (para [0039], [0048]); amlodipine is the compound of formula (II) of the instant claims. In addition to calcium channel blockers, Hoyle teaches antihypertensive agents to include alpha blockers such as doxazosin (para [0036-0037]). Doxazosin is the compound of formula (III) of the instant claims. Hoyle teaches the amount of amlodipine to be administered to a patient to range from 0.1 mg. or lower, up to 25 mg. or more per day (para [0053], [0064]); additionally, Hoyle teaches these doses can apply to another antihypertensive (para [0076]). Hoyle teaches the antihypertensive agent, e.g., amlodipine, can be combined with the CNS stimulant in a single drug formulation for treatment, with specific combinations taught to include amlodipine and methylphenidate, amlodipine and methamphetamine, amlodipine and dextroamphetamine, and amlodipine and lisdexamphetamine (para [0090-0098]). Hoyle teaches administering the antihypertensive agent, e.g., amlodipine or doxazosin, on “at least a daily basis” (p. 9, claim 5); as such, it would have been prima facie obvious to one of ordinary skill in the art that Hoyle encompasses administering amlodipine or doxazosin at least once, twice, or multiple times daily as needed as recited by instant claim 12.
As such, one of ordinary skill in the art, before the effective filing date of the claims would have arrived at the claimed method of treating ADHD by administering a CNS stimulant in combination with an antihypertensive such as amlodipine or doxazosin in order to ameliorate the adverse effect of hypertension caused by CNS stimulants, and have had a reasonable expectation of success. Furthermore, as Hoyle teaches the therapeutic doses taught for amlodipine can be applied to another antihypertensive agent, it would have been prima facie obvious to have administered doxazosin at a dose from 0.1-16 mg. as recited by instant claim 10 in combination with a CNS stimulant to a patient with ADHD, once or multiple times daily, and have had a reasonable expectation of success.
Claim(s) 1-4, 13-14, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Waldo, WO 2008103538 A1, publ. 8/28/2008 in view of Bushra et. al., IJDDT, vol. 4(1), pp. 34-42, publ. 2013.
Waldo teaches a method of treating ADHD and other diseases involving inflammation and/or catecholamine imbalance by administering a CNS stimulant to a patient to maintain steady state serum drug levels for about 24 hours or longer after administration (title & abstract; para [0001], [0007]). Waldo teaches current treatments for ADHD include stimulants such as methylphenidate or amphetamine, but they do not address the catecholamine imbalance over the entire day (para [0006]). Waldo teaches an embodiment wherein the ADHD patient is administered a combination of a CNS stimulant and an anti-inflammatory agent to allow for effective serum levels of stimulant over the entire day (para [0009], [0020], [0024]). Waldo teaches anti-inflammatory agents for combination therapy include an NSAID (para [0074], [0079], [0098]).
Waldo doesn’t explicitly teach or suggest a compound of formula (I).
Bushra teaches aceclofenac as an NSAID that is stable to oxidative stress, heat, and photolytic stress (p. 34, 1st para & Fig. I):
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. Bushra further teaches aceclofenac is well-absorbed following oral administration (p. 34, 1st para), and is administered in one or two daily 100 mg. doses for anti-inflammatory and analgesic effects (pp. 35-36). Bushra teaches aceclofenac as both safe and effective, as well as having improved GI tolerance compared to other NSAIDs (p. 37, Conclusion).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have treated ADHD comprising administering to a subject in need thereof a CNS stimulant such as methylphenidate or amphetamine in combination with the compound of formula (I), aceclofenac, in consideration of the combined teachings of Waldo and Bushra. Waldo teaches a method of treating ADHD by administering a CNS stimulant in combination with an anti-inflammatory agent, such as an NSAID, while Waldo teaches aceclofenac as a safe and effective NSAID having improved GI tolerance compared to other NSAIDs. Waldo additionally teaches aceclofenac to be used as an anti-inflammatory or analgesic for various indications, at oral doses of 100 mg. administered once or twice daily. Therefore, one of ordinary skill in the art would have been motivated to have practiced the method of treating ADHD as taught by Waldo, utilizing aceclofenac as the NSAID for combination therapy, at the oral doses of 100 mg. administered once or twice daily given the guidance of Bushra, and have had a reasonable expectation of success.
Claim Rejections-Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 5-8, and 13-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-20 and 27-38 of copending Application No. 19247813 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a process of treating or prophylaxis of ADHD by administering a compound of formula (II)
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. Additionally, both sets of claims recite administering the compound at a dose from about 0.1-10 mg. (instant claim 6 & copending claim 27); and further administration of an additional agent selected from methylphenidate, dexamphetamine, lisdexamfetamine, atomoxetine, and guanfacine (instant claim 14 & copending claim 33).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 5-8, and 13-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 14, and 21-23 of copending Application No. 19427233 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a process of treating or prophylaxis of ADHD by administering a compound of formula (II). The copending claims recite the following enantiomer:
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, however, the instant claims encompass this enantiomer, from the shown structure of formula (II). Additionally, both sets of claims recite administering the compound at a dose from about 0.1-5 mg. (copending claim 2 & instant claim 6); further administration of an additional agent selected from methylphenidate, dexamphetamine, lisdexamfetamine, atomoxetine, and guanfacine (copending claim 12 & instant claim 14).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Information Disclosure Statements
The IDS filed on 7/28/23, 10/3/23, and 12/16/25 have been considered.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
Prosecution Insights