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 . Claims 1-23 filed December 19, 2025 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Group (I), claims 1-4 and 21-22 in the reply filed on 05/21/2026 is acknowledged.
Claims 5-20 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 05/21/2026.
Secondly, election without traverse of methyl phenidate as the species of one or more further pharmacological interventions in the reply filed on 05/21/2026 is acknowledged. Claims 22 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of one or more further pharmacological interventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/21/2026.
Priority
Acknowledgement is made of the continuation in part of Application 19247183 filed 06/24/2025. Application 19247183 is a continuation of Application 18274945 filed -7/28/2023. Application 18274945 claims foreign priority to PCT/EP2022/052142 filed 01/28/2022 and foreign application GB2101291.9 filed 01/29/2021.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The word “novel” should not be included at the beginning of the title of the invention and will be deleted when the Office enters the title into the Office’s computer records. See MPEP 606.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park (Clinical Therapeutics Vol. 28 pages 1837-1847. Published 2006).
Claim interpretation is as follows: Claims 1-4 are directed to a composition of S(-)-amlodipine.
Park (Clinical Therapeutics Vol. 28 pages 1837-1847. Published 2006) teaches a composition comprising the calcium channel antagonist S-amlodipine in a single administered dose of 5 mg (page 1837 left col., page 1838 left col., page 1839 left col. Figure 1).
Regarding the claimed limitation directed to use of the composition for the treatment of attention deficit hyperactivity disorder, or the administration of said composition once or twice a day (claims 3-4), such a limitation of the instant claims fails to patentably distinguish the instant claims over the cited prior art because such a limitation is an intended use of the composition (i.e., an intent to use the disclosed composition as treatment for attention deficit hyperactivity disorder, or an intent to administer a composition once or twice a day), which does not impart any physical or material characteristics to the composition that is not already present in the cited prior art. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble of not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.2d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 378, 42 USPQ2d 1550, 1554 and MPEP §2112.02(11). In the instant case, the cited prior art 5 mg dose of S(-)-amlodipine composition taught by Park meets each and every structural and physical limitation of the instantly claimed composition and, thus, would be reasonably expected to be capable of performing the intended use as instantly claimed, absent factual evidence to the contrary and further absent any apparent structural difference between the composition of the prior art and that of the instant claims.
Claim 21 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoyle (US2011/0136793 published 06/09/2011) as evidenced by Luksa (Journal of Chromatography B Vol. 703 pages 185-193 published 1997).
Claim 21 is directed to a composition (kit) comprising S(-)-amlodipine in combination with one or more pharmacological interventions selected from methylphenidate, amphetamine, lisdexamfetamine, atomoxetine, viloxazine, clonidine and guanfacine.
As recited in MPEP 2111.03, the transitional term "comprising" is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004). In the present case, the composition embodied within claim 21 does not exclude additional, unrecited elements, such as R(+)-amlodipine.
Applicant is also reminded of MPEP 2112 wherein the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004) (Claim at issue was a kit requiring instructions and a buffer agent. The Federal Circuit held that the claim was anticipated by a prior art reference that taught a kit that included instructions and a buffer agent, even though the content of the instructions differed, explaining "[i]f we were to adopt [applicant’s] position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product.").
Hoyle (US2011/0136793 published 06/09/2011) teaches CNS stimulants for treating attention deficit hyperactivity disorder, including the elected methylphenidate ([0019]-[0020], [0024]-[0026]). Hoyle teaches formulating amlodipine with methylphenidate as the calcium channel antagonist amlodipine is an adjuvant therapy for methylphenidate as methylphenidate is linked to causing high blood pressure in subjects (abstract, [0024]-[0029], [0031]-[0048], [0091], [0104], [0110] claims 1-6, 8). Hoyle teaches administering amlodipine in doses of 0.5 to 2.4 mg, which reads on the amounts embraced in claims 1-4 ([0063]-[0064]). Hoyle teaches a composition comprising the CNS stimulant in combination with the calcium channel antagonist in separate dosage forms, or alternatively in a single dosage form ([0079]).
As evidenced by Luksa (Journal of Chromatography B Vol. 703 pages 185-193 published 1997) amlodipine is on the market and in therapeutic use as a racemate in 1:1 ratio of both the R and S enantiomer (page 185 left col.). As such, the composition comprising amlodipine and methylphenidate as taught by Hoyle above comprises the claimed S(-)-amlodipine enantiomer in combination with both methylphenidate and the R(+)-amlodipine enantiomer, which reads on the composition embraced within the instant claims.
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.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Hoyle (US2011/0136793 published 06/09/2011) and Luksa (Journal of Chromatography B Vol. 703 pages 185-193 published 1997).
Hoyle (US2011/0136793 published 06/09/2011) teaches CNS stimulants for treating attention deficit hyperactivity disorder, including the elected methylphenidate ([0019]-[0020], [0024]-[0026]). Hoyle teaches formulating amlodipine with methylphenidate as the calcium channel antagonist amlodipine is an adjuvant therapy for methylphenidate as methylphenidate is linked to causing high blood pressure in subjects (abstract, [0024]-[0029], [0031]-[0048], [0091], [0104], [0110] claims 1-6, 8). Hoyle teaches administering amlodipine in doses of 0.5 to 2.4 mg, which reads on the amounts embraced in claims 1-4 ([0063]-[0064]). Hoyle teaches a composition comprising the CNS stimulant in combination with the calcium channel antagonist in separate dosage forms, or alternatively in a single dosage form ([0079]).
The difference between the instantly claimed composition and that of Hoyle is that Hoyle does not specifically teach wherein amlodipine is present as the S-enantiomer.
Luksa (Journal of Chromatography B Vol. 703 pages 185-193 published 1997) teaches the potent calcium channel blocker amlodipine is efficacious at treating hypertension and angina (abstract, page 185 left col.). Luksa teaches that like most other calcium channel blockers, amlodipine is administered as a racemate in 1:1 ratio of both the R and S enantiomer (page 185 left col.) Luksa also teaches enantiopure R(+)-amlodipine and S(-)-amlodipine. Luksa teaches that the R(+)-enantiomer and the S(-)-enantiomer do not have the same biological activity, as only S(-)-amlodipine possesses vasodilating properties (page 185 right col.).
Therefore, one of ordinary skill in the art of preparing a composition comprising the ADHD treating CNS stimulant methylphenidate and the calcium channel antagonist amlodipine, as amlodipine is an adjuvant therapy for a methylphenidate regimen, as methylphenidate is linked to causing high blood pressure in subjects as taught by Hoyle above, said skilled artisan would have found it prima facie obvious to utilize amlodipine, as the S(-)-enantiomer, in view of Luksa, arriving at the presently claimed composition.
MPEP 2143 provides rationale for a conclusion of obviousness including (A): Combining prior art elements according to known methods to obtain predictable results;
In the present case, it was known in the prior art of Luksa that the R(+)-enantiomer and the S(-)-enantiomer of amlodipine do not have the same biological activity, as only S(-)-amlodipine possesses the desired vasodilating properties (page 185 right col.). As such, said skilled artisan would have formulated amlodipine in the amlodipine and methylphenidate composition taught by Hoyle, as the S(-)-enantiomer to take advantage of the desired vasodilating properties afforded only by the S(-)-enantiomer.
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.
Claim 21 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of copending Application No. 18274945 in view of Hoyle (US2011/0136793 published 06/09/2011).
Claim 17 is directed to a kit comprising a compound of Formula (II) and further comprising one or more pharmacological interventions.
Formula (II) is the racemic form of amlodipine, which embraces both the R-enantiomer and the S-enantiomer, as found in the presently claimed kit composition.
The difference between the presently claimed kit composition and that of claim 17 of copending Application 18274945 is that claim 17 of Application 18274945 does not specifically teach wherein the one or more pharmacological interventions is selected from the group consisting of methylphenidate, amphetamine, lisdexamfetamine, atomoxetine, viloxazine, clonidine, and guanfacine.
Hoyle (US2011/0136793 published 06/09/2011) teaches CNS stimulants for treating attention deficit hyperactivity disorder, including the elected methylphenidate ([0019]-[0020], [0024]-[0026]). Hoyle teaches formulating amlodipine with methylphenidate as the calcium channel antagonist amlodipine is an adjuvant therapy for methylphenidate as methylphenidate is linked to causing high blood pressure in subjects (abstract, [0024]-[0029], [0031]-[0048], [0063]-[0064], [0091], [0104], [0110] claims 1-6, 8). Hoyle teaches administering amlodipine in doses of 0.5 to 2.4 mg, which reads on the amounts embraced in claims 1-4 ([0063]-[0064]). Hoyle teaches a composition comprising the CNS stimulant in combination with the calcium channel antagonist in separate dosage forms, or alternatively in a single dosage form ([0079]).
Therefore, one of ordinary skill in the art prior to the time of the invention would have found it prima facie obvious to incorporate methylphenidate into the kit comprising the racemic form of amlodipine (Formula (II)) as taught by claim 17 of copending Application 18274945, in view of Hoyle, arriving at the presently claimed composition with a reasonable expectation of success.
Motivation to incorporate methylphenidate with amlodipine flows logically from the fact that Hoyle teaches formulating amlodipine with methylphenidate as the calcium channel antagonist amlodipine is an adjuvant therapy for the ADHD medication methylphenidate, as methylphenidate is linked to causing high blood pressure in subjects (abstract, [0024]-[0029], [0031]-[0048], [0091], [0104], [0110] claims 1-6, 8).
Accordingly, said artisan would have readily predicted that the combination of amlodipine to the methylphenidate composition would have reduced cardiovascular disorders in the administered subject.
Claims 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 36-37of copending Application No. 19247813.
Claims 36-37 of copending Application 19247813 are directed to a kit comprising Formula (II) and further comprising one or more pharmacological interventions, wherein the one or more pharmacological interventions is selected from methylphenidate, amphetamine, lisdexamfetamine, atomoxetine, viloxazine, clonidine, and guanfacine. Said kit composition of claims 36-37 of copending Application 19247813 overlaps with the presently claimed kit composition as Formula (II) is the racemic form of amlodipine, which embraces both the R-enantiomer and the S-enantiomer, as found in the presently claimed kit composition.
Conclusion
In view of the rejections set forth above, no claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE W KOSTURKO whose telephone number is (571)270-5903. The examiner can normally be reached M-F 9:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CLINTON A BROOKS can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
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