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 .
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.
Election/Restrictions
Applicant’s election of Group I, claims 1-19 without traverse in the reply filed on 5/09/2026 is acknowledged.
Applicant elected compliant species of calcium channel inhibitor: verapamil
Examiner found prior art on applicant elected species therefore Markush search was not extended to other species of Autophagy disease according to Markush search practices.
Elected species reads on claims 1-19.
Claim 25 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/09/2026
Current Status of 18/708,955
This Office Action is in response to the amended claims of 05/09/2024.
Claims 1-2, 6-8, 18 and 25 are original; and 3-4, 9-17 and 19 are currently amended.
Claim 25 is withdrawn.
Claims 1-19 are examined in this office action.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 05/09/2024. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Priority
Effected filing date is 11/10/2021.
Claim Rejections - 35 USC § 102
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, 10, 11, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by J P BALLANTYNE et.al. (Journal of Neurology, Neurosurgery, and Psychiatry 1987;50:199-206)
J P BALLANTYNE et.al. discloses treatment myotonic disorder in patients with verapamil (applicant elected species) (page 199, second paragraph). Thus, anticipates the subject-matter of present claims 1, 3-4, 10-11, and 19. Please note J P BALLANTYNE et.al. further teaches method of treating myotonic disorder with nifedipine(another species of calcium channel inhibitor, in claim 3).
Claim 2 is directed to calcium channel as the Cav1. calcium channel, examiner interpret this as inherent properties of the verapamil to block Cav1 calcium channel. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01(I). Thus anticipating claim 2.
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) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over
J P BALLANTYNE et.al. (Journal of Neurology, Neurosurgery, and Psychiatry 1987;50:199-206)
In view of
Montagnese, F ( Curr Treat Options Neurol (September 27, 2021) 23: 31)
In further view of
Anisel et.al. (PHARMACEUTICAL DOSAGE FORMS AND DRUG DELIVERY SYSTEMS) 7th edition, 1999.
1. Determining the scope and contents of the prior art.
JP Ballantyne et.al teaches claims 1-4, 10-11, and 19.
Montagnese discloses treatment of myotonic disorder with mexiletine, lamotrigine, carbamazepine, oxcarbazepine, flecainide, propaphenone, phenytoin, and ranolazine(page 4,5) (partially teaching claims 17-18).
Anisel et.al. teaches dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50)
2. Ascertaining the differences between the prior art and the claims at issue.
Although JP Ballantyne et.al teaches treatment of myotonia with verapamil, Ballantyne does not teach the use of additional agent for treating myotonic disorder or the dosage of verapamil.
Although Montagnese, F teaches treatment of myotonia with mexiletine, lamotrigine, carbamazepine, oxcarbazepine, flecainide, propaphenone, phenytoin, and ranolazine (partially teaching claims 17-18) Montagnese, F does not teach use of verapamil or nifedipine for treating myotonic disorder.
Although Anisel teaches dosage of pharmaceutical compounds to the patients, Anisel does not teach the dosage of verapamil administered to patients.
3. Resolving the level of ordinary skill in the pertinent art.
The level of ordinary skill is an artisan who have sufficient background in developing treatment myotonic disorder and is looking to improve the prognosis of the disorder
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A person skilled in the art would be motivated to combine prior art of JP Ballantyne et.al which teaches use of verapamil and nifedipine (Ballantyne et.al, page 199, second paragraph) for treating myotonic disorder; and prior art of Montagnese, F for treating myotonic disorder with mexiletine, lamotrigine, carbamazepine, oxcarbazepine, flecainide, propaphenone, phenytoin or ranolazine (Montagnese, F , page 4-5) because the both verapamil and additional agents, mexiletine, lamotrigine, carbamazepine, oxcarbazepine, flecainide, propaphenone, phenytoin or ranolazine are used for treating myotonic disorder. It would be expected combination of verapamil with additional agent such as carbamazepine would have a better prognosis in treating myotonic disorder than individually. Therefore it would be prima facia obvious to combine the teaching of Ballantyne et.al, with Montagnese, F for treating myotonic disorder. Thus teaching all the elements of claims 1-4, 10-11, and 17-19
Claims 4-9, are drawn to different type of myotonic disorder. J P BALLANTYNE et.al.is silent on the type of myotonic disorder treated with verapamil examiner interpret this using broadest reasonable interpretation to include various type of myotonic disorder including myotonic dystrophy, autosomal dominant or recessive myotonia congenita,or sodium channel myotonia etc (teaching claims 4-9).
Claim 16 is directed to the method of administering agent to the subject. J P BALLANTYNE et.al.is silent on this topic, therefore using broadest claim interpretation, a person skilled in the art is expected to deliver agent to the subject intratumorally, intravenously, subcutaneously, intraosseously, orally, transdermally, sublingually, in sustained release, in controlled release, in delayed release, or as a suppository since these are all well-known routes of administration. Thus teaching claim 16.
Claims 12-15 are directed to dosage and frequency of the dosage of compound of calcium channel inhibitor. Examiner interprets these attributes as variables the artisan would normally be expected to routinely optimize. For example, dosages of pharmaceuticals and frequency of the dosage are routinely optimized based on body weight and body surface area (Anisel et.al. page 50). Generally, dosage will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such attributes are critical. The specification does not indicate the dosage and frequency of the dosage to be critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A).
Conclusion
No claims are allowable as written.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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