DETAILED ACTION
This office action is in response to applicant’s filing dated February 25, 2026.
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 claims
Claims 1 – 13, 15 and 17 - 22 are pending in the instant application. Acknowledgment is made of Applicant’s amendments filed February 25, 2026.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on February 25, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Objections and/or Rejections and Response to Arguments
Applicants' arguments, filed on February 25, 2026, have been fully considered.
Acknowledgement is made of the Applicant’s amendment of claim 21. The amendments as shown herein: “The method according to claim 3, wherein the levodopa, or a pharmaceutically acceptable derivative thereof, is administered total daily dose equivalent to 500 to 1000 mg of levodopa”.
Accordingly, the rejection of claim 21 under 35 U.S.C. 112(b) for insufficient antecedent basis of limitation is withdrawn.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections, NOT Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Maintained Objections and/or Rejections
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 – 7, 10 – 13, 15 and 17 – 22 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Soares da Silva et al (WO 2016/083875 A1, hereinafter Soares da Silva).
Regarding claims 1, 4 – 5, 10 – 13 and 17 - 19, drawn to a method of treating the symptoms of Parkinson’s disease (PD) in a patient suffering from unpredictable motor fluctuations such as “end-of-dose” motor fluctuations, comprising administering to the patient a therapeutically effective amount of opicapone or a pharmaceutically acceptable derivative thereof, in combination with a therapeutically effective amount of levodopa, or a pharmaceutically acceptable derivative thereof, where the combination further comprising a DOPA decarboxylase inhibitor (DDCI) such as carbidopa or benserazide, where the treatment reduces the time spent suffering from unpredictable motor fluctuations. Said treatment further reduces absolute "off'-time by at least 30 minutes per day and accompanied by an equivalent increase in absolute "on"-time, wherein the treatment lasts at least 10 weeks.
Soares da Silva teaches a method of slowing or delaying the progression of PD by administering to a patient:
(i) levodopa;
(ii) carbidopa or benserazide; and
(iii) opicapone (page 6, lines 35 - 38 and page 7, lines 1 – 3).
Opicapone may be indicated as adjunctive therapy to immediate release or modified release preparations of levodopa/benserazide or levodopa/carbidopa in adult patients with Parkinson's disease and end-of-dose motor fluctuations (page 9, lines 25 – 28). The method of treatment, taught by Soares da Silva demonstrates a reduction in OFF time compared to starting the treatment and an increase in ON time compared to starting the treatment. The reduction in OFF time could suitably be of at least 30 minutes, and a corresponding relative improvement in ON time without troublesome dyskinesia (drug-induced involuntary muscle movements) may similarly be employed to determine progression of disease (page 16, lines 31 – 37 and page 17, lines 1 – 7; page 27 and 28, Figures 1 and 2). The therapy intends to reduce the unpredictable motor complications or fluctuation (e.g. paroxysmal ON-OFF phenomenon, freezing) duration (page 4, lines 13 – 14).
Regarding duration of a treatment, Soares da Silva teaches 1-year open label (OL)-part trial, in which all patients were treated with opicapone (OPC, 25 or 50-mg), where all subjects began with 25-mg OPC once daily (QD) for 1-week, then, the investigator freely adjusted the levodopa therapy (page 17, example 1A). One year is approximately equivalent to 52 weeks, which is longer than 10 weeks and, thus falls within the claimed limitations “at least 10 weeks”.
Regarding claims 2, 3, 6 – 7 and 20 - 22, drawn to treatment dosages, wherein:
opicapone is administered once daily at a dose equivalent to 10 to 100 mg or once daily at a dose equivalent to 25 to 50 mg;
levodopa, or a pharmaceutically acceptable derivative thereof, is administered 3 to 10 times per day at a total daily dose equivalent to 300 to 2000 mg or at a daily dose equivalent to 500 to 1000 mg;
carbidopa or benserazide is administered 3 to 10 times per day at a total daily dose of 25 to 500 mg or 3 to 10 times per day at a total daily dose of 75 to 250 mg, wherein the levodopa, or a pharmaceutically acceptable derivative thereof, and the carbidopa or benserazide are administered in a single dosage unit.
Soares da Silva teaches the administration of opicapone by once a day dosing, where individual dose is 50 mg per day (page 8, lines 6 – 8). The levodopa and carbidopa or benserazide will usually be administered at the single dosage unit in a mass ratio of 1:4 of carbidopa or benserazide with levodopa, for example 25 mg benserazide or carbidopa together with 100 mg levodopa (page 8, lines 24 – 25 and 32 – 33), 2 to 10 times a day (page 9, line 1). If single dosage unit of carbidopa or benserazide containing 25 mg benserazide or carbidopa with levodopa containing 100 mg of levodopa is administered to the patient 3 times a day, as taught by Soares da Silva, the daily dosage of levodopa will be 300 mg and daily dosage of benserazide or carbidopa will be 75 mg. If single dosage unit of carbidopa or benserazide with levodopa containing 25 mg benserazide or carbidopa and 100 mg levodopa is administered to the patient 10 times a day, as taught by Soares da Silva, the daily dosage of levodopa will be 500 mg and daily dosage of benserazide or carbidopa will be 250 mg. Thus, dosages taught by Soares da Silva fall within the ranges of instant claims. MPEP 2131.03.I states: "[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)). "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023).
Regarding claim 15, drawn to a method wherein the patient is diagnosed with Parkinson's disease prior to administering the therapeutically effective amount of opicapone, or a pharmaceutically acceptable derivative thereof, in combination with levodopa, or a pharmaceutically acceptable derivative thereof.
Soares da Silva teaches the method of slowing or delaying progression of PD in a patient diagnosed with, but have not previously taken medication for treatment of Parkinson's disease (page 12, lines 27 – 28).
Thus, the method taught by Soares da Silva anticipates the method of instant claims 1 – 7, 10 – 13, 15 and 17 – 22.
Response to Arguments
Applicant argues:
- Present claims 1 and 17 and their dependent claims are directed to a method of treating the symptoms of Parkinson's disease in a patient suffering from unpredictable motor fluctuations and a method of treating unpredictable motor fluctuations in a patient suffering from Parkinson's disease;
- The Examiner's rejection relies on "end-of-dose" motor fluctuations being considered within the scope of unpredictable motor fluctuations. They are not. Page 6, lines 24-28, of the present application define "end-of-dose motor fluctuations" as "the predictable re-emergence or worsening of symptoms before administration of the next dose of levodopa therapy".
- The Cited Reference of Soares da Silva discloses a reduction in OFF time, which is a reduction in predictable motor complications in a patient.
Examiner’s response:
Applicant's arguments have been fully considered but they are not persuasive because: instant claim 10, which recites the method for treating, where the symptom being treated is "end-of-dose" motor fluctuations. Claim 1, on which claim 10 is being dependent, recites the method “of treating the symptoms of Parkinson’s disease (PD) in a patient suffering from unpredictable motor fluctuations”. Thus, "end-of-dose" motor fluctuations symptom falls within the scope of claim 1, which discloses the method for treatment of unpredictable motor fluctuations in Parkinson’s patient. Furthermore, instant claims 11 and 12, recite the method where the disclosed treatment reduces absolute "off'-time and increase in absolute "on"-time. Since claims 11 and 12 are also being dependent on claim 1, claims 11 and 12 are within the scope of claims 1 which recites the method of treating unpredictable motor fluctuations in Parkinson’s patient.
Thus, Soares da Silva discloses the method for treating the same symptoms (unpredictable motor fluctuations) in the same patient (patient suffering from Parkinson’s disease) with the same drug combination (levodopa, opicapone and carbidopa or benserazide), given in the same or similar doses as instantly claimed.
Therefore, Applicant’s arguments are not persuasive and the rejection of claims 1 – 7, 10 – 13, 15 and 17 – 22 as anticipated by Soares da Silva is maintained.
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, 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Soares da Silva et al (WO 2016/083875 A1), in view of Quinn (Neurology. 1998 Aug;51(2 Suppl 2):S25-9).
Instant claims are drawn to a method of treating the symptoms of Parkinson’s disease (PD) in a patient suffering from unpredictable motor fluctuations, comprising administering to the patient a therapeutically effective amount of opicapone in combination with a therapeutically effective amount of levodopa and carbidopa or benserazide, wherein patient suffering from sudden and random changes from an "on" state to an "off' state over a period of less than 10 minutes, such as over a period of 5 seconds to 5 minutes, with no apparent relationship to the timing of administration of levodopa.
Soares da Silva teaches a method of slowing or delaying the progression of PD by administering to a patient:
(i) levodopa;
(ii) carbidopa or benserazide; and
(iii) opicapone (page 6, lines 35 - 38 and page 7, lines 1 – 3). Soares da Silva further teaches that in highly advanced PD, patients may suffer from severe and highly unpredictable and rapid motor fluctuations, and the therapy intends to reduce the unpredictable motor complications or fluctuation (e.g. paroxysmal ON-OFF phenomenon, freezing) duration (page 4, lines 13 – 14).
Soares da Silva does not explicitly teach where sudden and random changes from an "on" state to an "off' state over a period of less than 10 minutes, such as over a period of 5 seconds to 5 minutes, with no apparent relationship to the timing of administration of levodopa.
However, Quinn teaches short-duration motor fluctuations in patient with PD, where the fluctuations last seconds to minutes and comprise sudden transient freezing (or motor blocks), and its opposite, paradoxic kinesis (page S26, table 1). This sort of condition is not predictably influenced by any modification in drug treatment and more disease-related than treatment-related (page S25, left column 2nd -4th paragraph and right column 1st paragraph). Moreover, UPDRS (Unified Parkinson's Disease Rating Scale) questionnaire, in part IV, section B contains following questions:
36. Are "off" periods predictable?
37. Are "off" periods unpredictable?
38. Do "off" periods come on suddenly, within a few seconds?
(https://neurotoolkit.com/updrs/).
Although, prior art teaches time period of sudden changes from an "on" state to an "off' state as a “few seconds to a few minutes” without pointing out particular time it is relevant to instantly claimed sudden changes over time period of “5 seconds to 5 minutes”. Furthermore, according to prior art teachings, unpredictable and rapid motor fluctuations symptoms appears to be more or less common in PD patients.
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply a known in the art treatment combination of opicapone, levodopa and carbidopa or benserazide to all the PD patients with motor fluctuation of different etiology, frequency and duration with the reasonable expectation of success. The one of ordinary skills would be motivated to do so in search of an effective method of treatment of patients suffering from PD, since prior art teaches opicapone, levodopa and carbidopa or benserazide drug combination is effective in slowing down PD progress and improving life condition in PD patients.
Therefore, taking all together, taught by prior art, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant argues:
- The Examiner's analysis does not recognize that Soares da Silva fails to teach the treatment of unpredictable motor fluctuations of any type. The introduction of Quinn also discusses predictable and unpredictable motor fluctuations, albeit using slightly outdated terminology.
- all relevant documents agree that predictable and unpredictable motor fluctuations are different symptoms occurring at different stages of disease, so, patients with unpredictable motor fluctuations require specific treatment.
- The combination of Soares da Silva and Quinn cannot render the claims obvious. Further, Applicant has performed statistical analysis on patients who developed unpredictable motor fluctuations (n = 278) and those who did not (n = 480) during the course of a clinical study. The results confirm that those who developed motor fluctuations observed a greater reduction in total OFF time is not only reduced in the patients with unpredictable motor fluctuations, but also treated to a greater extent over though it is considered the "complicated stage" of the disease. Such an improvement could not be predicted by theory and confirms that the claims involve inventive step.
Examiner’s response:
Applicant's arguments have been fully considered but they are not persuasive because: as explained above in the 102 rejection section, Soares da Silva discloses the method for treating the same symptoms in the same patient with the same regimen as instantly claimed. Although Applicant demonstrates the results of improvement of patient conditions, the method, taught by Soares da Silva would inherently have the same outcomes, because: "treatment to a greater extent over though it is considered the "complicated stage" of the disease" will naturally flow from the teachings of (or method made obvious by) the prior art (see above rejection), since the same regimen (levodopa, opicapone and carbidopa or benserazide) is being administered to the same subjects (patient suffering from unpredictable motor fluctuations associated with Parkinson’s disease). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. Moreover, as applied in the above rejection, Soares da Silva teaches that in highly advanced PD, patients may suffer from severe and highly unpredictable and rapid motor fluctuations, and the therapy intends to reduce the unpredictable motor complications or fluctuation (e.g. paroxysmal ON-OFF phenomenon, freezing) duration.
Therefore, Applicant’s arguments are not persuasive and the rejection of claims 1, 8 and 9 as obvious over teachings of Soares da Silva and Quinn is maintained.
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 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims:
1, 2, 5, 6,10, 11 and 17 - 21 of U.S. Patent No. US 10,357,468 B2;
1, 2, 3, 5 and 6 of U.S. Patent No. US 10,065,944 B2;
1, 6,10 and 11, of U.S. Patent No US 12,129,247 B2;
1, 2, 5, 6 – 11 and 15, of U.S. Patent No. US 8,524,746 B2;
1, 2, 4, 5, 9 - 12, 14 and 15 of U.S. Patent No. US 9,745,290 B2;
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method of treating the symptoms of Parkinson’s disease (PD) in a patient suffering from unpredictable motor fluctuations, comprising administering to the patient a therapeutically effective amount of opicapone (2,5-dichloro-3-[5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl]-4,6-
dimethylpyridine 1-oxide) or a pharmaceutically acceptable derivative thereof, in combination with a therapeutically effective amount of levodopa, or a pharmaceutically acceptable derivative thereof, where the combination further comprising a DOPA decarboxylase inhibitor (DDCI) such as carbidopa or benserazide.
The claims of U.S. Patent No. US 10,357,468 B2 are directed to a method of slowing progression of Parkinson's Disease which comprises administering to a patient not previously treated with a COMT inhibitor an effective amount of:
(i) levodopa;
(ii) an AADC inhibitor such as carbidopa or benserazide; and
(iii) opicapone.
The claims of U.S. Patent No. US 10,065,944 B2 are directed to a method of treatment of Parkinson's disease comprising administering to a human patient suffering from said disease a therapeutically effective amount of compound 5-[3-(2,5-dichloro-4,6-dimethyl-1-oxy-pyridin-3-yl)-[1,2,4]oxadrnzol-5-yl]3-nitrobenzene-1,2-diol (opicapone) or a pharmaceutically acceptable salt, wherein the compound is administered in combination with levodopa and an AADC inhibitor, carbidopa or benserazide.
The claims of U.S. Patent No. US 12,129,247 B2 are directed to a method of treating of Parkinson's disease comprising administering to a human patient suffering from said disease a therapeutically effective amount of compound 5-[3-(2,5-dichloro-4,6-dimethyl-1-oxy-pyridin-3-yl)-[1,2,4]oxadrnzol-5-yl]3-nitrobenzene-1,2-diol (opicapone) or a pharmaceutically acceptable salt, wherein the compound is administered in combination with levodopa and an AADC inhibitor carbidopa or benserazide.
The claims of U.S. Patent No. US 8,524,746 B2 are directed to a method of treating a movement disorder in a patient in need thereof comprising administering to the patient a pharmacologically effective dose of 5-[3-(2,5-dichloro-4,6-dimethyl-1-oxy-pyridin-3-yl)-[1,2,4]oxadrnzol-5-yl]3-nitrobenzene-1,2-diol (opicapone) or a pharmaceutically acceptable salt thereof wherein the compound is administered in combination with levodopa and an AADC inhibitor, and wherein the movement disorder is Parkinson's disease.
The claims of U.S. Patent No. US 9,745,290 B2 are directed to a composition comprising 5-[3-(2,5-dichloro-4,6-dimethyl-1-oxy-pyridin-3-yl)-[1,2,4]oxadrnzol-5-yl]3-nitrobenzene-1,2-diol (opicapone) in combination with levodopa and an AADC inhibitor. The patented claims are also directed to a method of treating Parkinson's disease in a patient in need thereof comprising administering to the patient said composition.
Thus, method of treatment of Parkinson’s disease using composition of the granted clams would anticipate the instantly claimed composition and its method of use.
Claims 1 – 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8, 27, 28, 29, 31 of Patent No. US 9,132,094 B2.
The instant claims are directed to a method of treating the symptoms of Parkinson’s disease (PD) in a patient suffering from unpredictable motor fluctuations, comprising administering to the patient a therapeutically effective amount of opicapone (2,5-dichloro-3-[5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl]-4,6-
dimethylpyridine 1-oxide) or a pharmaceutically acceptable derivative thereof, in combination with a therapeutically effective amount of levodopa, or a pharmaceutically acceptable derivative thereof, where the combination further comprising a DOPA decarboxylase inhibitor (DDCI) such as carbidopa or benserazide.
The claims of Patent No. US 9,132,094 B2 are directed to a pharmaceutical formulation comprising 2,5-dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine 1-oxide (opicapone) in combination with L-DOPA, and a peripheral AADC inhibitor. Said formulation is useful for treatment of symptoms of Parkinson’s disease.
Thus, since prior art teaches the pharmaceutical formulation, useful for treatment of symptoms of Parkinson’s disease, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply a known in the art combination of opicapone, levodopa and AADC inhibitor to treat PD patients since prior art teaches this combination is useful for treatment PD conditions with the reasonable expectation of success.
Thus, the instantly claims method would be rendered obvious over formulation of patented claims.
Claims 1 – 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims:
1, 4, 18 and 19 of copending Application No. 18/273,515;
61 – 65 and 77 – 79, of copending Application No. 18/924,015;
1, 5, 7, 15 and 16 of copending Application No. 18/201,920 (reference applications).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method of treating the symptoms Parkinson’s disease (PD) in a patient suffering from unpredictable motor fluctuations such as “end-of-dose” motor fluctuations, comprising administering to the patient a therapeutically effective amount of opicapone (2,5-dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine 1-oxide) or a pharmaceutically acceptable derivative thereof, in combination with a therapeutically effective amount of levodopa, or a pharmaceutically acceptable derivative thereof, where the combination further comprising a DOPA decarboxylase inhibitor (DDCI) carbidopa or benserazide.
The copending claims of Application No.18/273,515 are directed to a method for the treatment of pain associated with Parkinson's disease, comprising administering a therapeutically effective amount of opicapone, or a pharmaceutically acceptable derivative thereof, in combination with a therapeutically effective amount of levodopa, or a pharmaceutically acceptable derivative thereof and DOPA decarboxylase inhibitor (DDCI, wherein the patient to be treated experiences end-of-dose motor fluctuations.
The copending claims of Application No.18/924,015 are directed to a method of treating Parkinson’s disease comprising administering to a human patient therapeutically effective amount of opicapone (2,5-dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine 1-oxide) in combination with a therapeutically effective amount of levodopa, or a pharmaceutically acceptable derivative thereof, where the combination further comprising a DOPA decarboxylase inhibitor (DDCI) carbidopa or benserazide.
The copending claims of Application No.18/201,920 are directed to a method of treating a patient with Parkinson's disease, comprising administering to the patient an effective amount of opicapone with an effective amount of levodopa and an effective amount of a DDCI.
Thus, the method of copending claims anticipate the instantly claimed method.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues:
Applicant notes that US 10,357,468 is derived from Soares da Silva (the reference cited by the Examiner in the novelty and obviousness rejections), thus the present claims would be patentably distinct should the claims be held inventive over Soares da Silva.
Examiner’s response:
Applicant's arguments have been fully considered but they are not persuasive because: as applied to the arguments’ response above, Soares da Silva discloses the method for treating the same symptoms in the same patient with the same regimen as instantly claimed. Thus, instant claims are not patentably distinct form claims of US Patent US 10,357,468. Other patents and copending applications, listed in the above Double patenting rejection section, teach the same of similar formulations suitable to treat the same disease or conditions.
Therefore, Applicant’s arguments are not persuasive and the rejection of claims on the ground of nonstatutory double patenting over claims of U.S. Patent No. US 10,357,468 B2, U.S. Patent No. US 10,065,944 B2, U.S. Patent No US 12,129,247 B2, U.S. Patent No. US 8,524,746 B2, U.S. Patent No. US 9,745,290 B2, as well as provisional nonstatutory double patenting rejection over claims of copending applications No. 18/273,515, No. 18/924,015 and No. 18/201,920 is maintained.
Conclusion
Claims 1 – 13, 15 and 17 – 22 are rejected. No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELENA V VISHNYAKOVA whose telephone number is (571)272-3781. The examiner can normally be reached 7:30am - 5pm ET.
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/E.V.V./Examiner, Art Unit 1691
/SAVITHA M RAO/Primary Examiner, Art Unit 1691