DETAILED ACTION
Claims 1-29 were pending; Applicant has amended claims 1-3 and 28-29; and canceled claims 4, 7, 10, 15-17, 20, 23 per the reply of 6/16/2026.
Claims 1-3, 5-6, 8-9, 11-14, 18-19, 21-22, and 24-29 are pending and the subject of the Office Action below.
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.
Claim Rejections - 35 USC § 102
(Maintained)
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 1-3, 5-6, 8-9, 11-14, 18-19, 21-22, and 24-29 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 5-6, 8-9, and 11-12 are all to the physical structure of the drug, Tideglusib meets the limitation, thereby anticipating the claims.
Claims 13-14 are directed towards the disease including DM1. This is a natural property of the disease, myotonic dystrophy type 1, as such this is anticipated.
Claims 18-19, 21-22 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.
Response to Arguments: Applicant argues that the prior art fails to teach or suggest the fact that Tideglusib binds to RNA with CUG repeats. Applicant states the art does not teach binding to RNA repeats. Therefore, Applicant believes the art is insufficient to reject the claims.
The MPEP 2112, II “INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE RELEVANT TIME” states:
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) ("[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention."); Abbott Labs v. Geneva Pharms., Inc., 182 F.3d 1315, 1319, 51 USPQ2d 1307, 1310 (Fed. Cir. 1999) ("If a product that is offered for sale inherently possesses each of the limitations of the claims, then the invention is on sale, whether or not the parties to the transaction recognize that the product possesses the claimed characteristics."); Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1348-49, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999) ("Because ‘sufficient aeration’ was inherent in the prior art, it is irrelevant that the prior art did not recognize the key aspect of [the] invention.... An inherent structure, composition, or function is not necessarily known."); SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343-44, 74 USPQ2d 1398, 1406-07 (Fed. Cir. 2005) (holding that a prior art patent to an anhydrous form of a compound "inherently" anticipated the claimed hemihydrate form of the compound because practicing the process in the prior art to manufacture the anhydrous compound "inherently results in at least trace amounts of" the claimed hemihydrate even if the prior art did not discuss or recognize the hemihydrate); In re Omeprazole Patent Litigation, 483 F.3d 1364, 1373, 82 USPQ2d 1643, 1650 (Fed. Cir. 2007) (The court noted that although the inventors may not have recognized that a characteristic of the ingredients in the prior art method resulted in an in situ formation of a separating layer, the in situ formation was nevertheless inherent. "The record shows formation of the in situ separating layer in the prior art even though that process was not recognized at the time. The new realization alone does not render that necessary [sic] prior art patentable.").
In this case the art teaches giving a patient with DM1 400 mg and 1000 mg of Tideglusib which resulted in treating the disease and improving neuromuscular symptoms. The Tideglusib once administered to the patient will inherently (as a function of its chemical properties interacting with the patient) inhibit CUG RNA repeats. Therefore the teaching of the art, while silent on this property anticipated the instant claims.
Conclusion
No claims allowed.
THIS ACTION IS MADE FINAL. 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 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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