DETAILED ACTION
Claims 1-29 are pending.
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
The instant application, filed 2/10/2023 is a Continuation of 17/749,748, filed 5/20/2022, now abandoned. 17/749,748 Claims Priority from Provisional Application 63/191,531, filed 5/21/2021.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 2/10/2023 in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statement is being considered by the Examiner.
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 1-23 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.
Claims 1, 2, and 3 all state the limitation to “Formula I or a pharmaceutically acceptable salt, prodrug or solvate thereof.” The Specification on Page 7 defines the Formula as:
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The Formula has 8 variables, which are not defined by reference to the Formula alone. Therefore the metes and bounds of the structures claimed by Applicant are indefinite.
Claim Rejections - 35 USC § 112(b)
Claims 1-12 and 18-23 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.
Claims 1-3 all require the limitation, “a disease associated with a RNA molecule having an abnormal repeat sequence in a subject.” The metes and bounds the diseases claimed by Applicant are indefinite. Firstly, “a RNA molecule having an abnormal repeat sequence” is not defined by Applicant in any way as to indicate what is “abnormal” and the number and scope of repeats required to cause a disease. There is no art accepted definition of “an abnormal repeat sequence” and there are no art accepted diseases associate with this abnormal RNA repeat. Applicant does list some diseases, see claims 13-14, and Applicant dose further refine the repeats, see claims 15-17, but Applicant has not defined this broad term in claims 1-3 and therefore the diseases and the abnormal repeat sequences are not defined and the metes and bounds of these terms are indefinite.
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 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.
Claims 1-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoffman Neurology Live October 31, 2018 with evidence from Clinical Trials.gov Identifier NCT02858908 published December 27, 2018.
Claim 1 requires a method of treating a disease associated with a RNA molecule having an abnormal repeat sequence in a subject, comprising administering to a subject in need thereof a therapeutically- effective amount of a compound of Formula I or a pharmaceutically acceptable salt, prodrug or solvate thereof.
Interpretation, “a disease associated with a RNA molecule having an abnormal repeat sequence in a subject,” includes within the scope the species of myotonic dystrophy type 1.
Interpretation, “a compound of Formula I,” includes Tideglusib.
Hoffman teaches patients with myotonic dystrophy type 1 were given 400 mg and 1000 mg of Tideglusib, treating the disease and improving neuromuscular symptoms.
Claim 2 is anticipated by the same teaching as “a method of preventing a disease associated with a RNA molecule having an abnormal repeat sequence in a subject” includes preventing the progression of the symptoms of a patient with myotonic dystrophy type 1.
Claim 3 is anticipated as “inhibiting a RNA molecule” is a physical property of the drug. Since myotonic dystrophy type 1 has the RNA, and Tideglusib is administered, the drug will naturally inhibit the RNA.
Claims 4-12 are all to the physical structure of the drug, Tideglusib meets the limitation, thereby anticipating the claims.
Claims 13-17 are directed towards the RNA molecule that is inhibited. This is a natural property of the disease, myotonic dystrophy type 1, as such this is anticipated.
Claims 18-23 are to an oral formulation. The drug was given orally as noted in Hoffmann.
Claims 24-29 are more specific, and to a dose of 300-100 mg. This is taught by Hoffman as well.
All the claims are anticipated.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J SCHMITT whose telephone number is (571)270-7047. The examiner can normally be reached M-F 8-6 MidDay Flex.
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/MICHAEL J SCHMITT/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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