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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11 September 2025 has been entered.
Status
Applicant’s response dated 11 September 2025 to the previous Office action dated 11 July 2025 is acknowledged. Pursuant to amendments therein, claims 2-4, 7-9, and 13-20 are pending in the application.
The drawings remain objected to as discussed below.
The claim objection made in the previous Office action is withdrawn in view of applicant’s claim amendments, but a new claim objection is made herein.
The rejection under 35 U.S.C. 103 made in the previous Office action is withdrawn in view of applicant’s claim amendments, but new rejections under 35 U.S.C. 102 and 103 are made herein in view of applicant’s claim amendments.
Drawings
The drawings were received on 11 September 2025. These drawings are unacceptable.
The drawings are objected to because each view is not independently identified by “FIG.” (i.e., all capital letters) followed by a number followed by a capital letter (if needed) as required by 37 CFR 1.84(u)(1) (e.g., each figure should be independently labeled FIG. 1A, FIG. 1B, etc. and should not also be labeled FIG. 1, FIG. 1 (cont’d), etc.); and also the view numbers for FIG. 12E and FIG. 13A are partially cut off. Although applicant provided replacement sheets adding Fig. 1A, Fig. 1B, etc. as view numbers, applicant failed to remove all the incorrect view numbers (e.g., “Fig. 1” on the right side of sheet 1, etc.). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 2 is objected to because of the following informalities: for clarity regarding the Markush grouping of disorders, the “and” should be deleted from the 7th line from the end of the claim, and the “and” in the 6th line from the end of the claim should be changed to “or”. Appropriate correction is required.
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) 2-3, 7-9, and 13-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johnson, II et al. (US 2012/0122792 A1; published 17 May 2012).
Johnson, II et al. discloses a method of treating a disease or condition of the Central Nervous System (CNS) such as Parkinson's disease, Alzheimer's disease, Amyotrophic lateral sclerosis (ALS), or Huntington's disease (i.e., dementia-associated tauopathies) (claim 5) comprising administering to a subject in need thereof a second generation anti-psychotic agent such as amisulpride (i.e., a structure of formula (II)), clozapine (i.e., a structure of formula (VI)), or lurasidone (i.e., a structure of formula (III)) (i.e., 5-HT7 receptor antagonists) (claim 7).
Regarding claim 7, since the claimed compound and the compound of Johnson, II et al., are identical as discussed above, they necessarily result in identical properties (i.e., the properties are inherent), including the claimed property of prevention of both receptor-induced phosphorylation and accumulation of Tau proteins when administered, given that compositions that are physically the same must have the same properties per MPEP 2112.01(II), and thus must produce the same results when administered, and also given that the method of Johnson, II et al. is the same as the clamed method.
Regarding claims 13-19, although such claims further limit particular substituents in formulas (I)-(VI), they do not specify that the claimed method must comprise any particular formula (I)-(VI), and Johnson, II et al. discloses compounds of formulas (II), (III), and (VI) as discussed above. Nevertheless, regarding claims 16-17, the amisulpride of Johnson, II et al. has R2 and R4 ethyl and R3 methyl, as claimed; and regarding claim 18, the lurasidone of Johnson, II et al. has D as claimed; and regarding claim 19, the clozapine of Johnson, II et al. has R13 C1 alkyl, as claimed.
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.
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) 2-4, 7-9, and 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gibbs et al. (WO 2013/038200 A2; published 21 March 2013; of record) in view of Stone et al. (U.S. Patent Number 5,281,607; issued 25 January 1994).
Gibbs et al. discloses an adrenoceptor antagonist such as SB-269,970 (i.e., a compound encompassed by instant formula (I), having a molecular weight of about 352 Dalton, a 5-HT7 receptor antagonist) or mianserin (i.e., a compound encompassed by instant formula (V)) (claim 22) used in the treatment, prevention or amelioration of neurodegenerative disorders such as Alzheimer’s disease, Huntington’s disease, or Parkinson’s disease (i.e., tauopathies, dementia-associated tauopathies) (claim 24) wherein a composition including the antagonist is administered to a person in need of such treatment (page 10 lines 4-35).
Although Gibbs et al. discloses treatment of neurodegenerative disorders, Gibbs et al. does not explicitly disclose treatment of a specific tauopathy other than Alzheimer’s disease, Huntington’s disease, or Parkinson’s disease, as claimed.
Stone et al. discloses a method for treating an animal such as a human suffering from a neurodegenerative disease comprising administering to the animal an adrenergic receptor (i.e., adrenoreceptor) antagonist (claims 1, 3) wherein neurodegenerative diseases include Alzheimer’s disease, Huntington’s Chorea (i.e., Huntington’s disease), Parkinson’s disease, Senile Dementia of Lewy body type (i.e., Dementia with Lewy Bodies), progressive supranuclear palsy, infantile spinal muscular atrophy, and juvenile spinal muscular atrophy (i.e., spinal muscular atrophy (SMA)) (claim 4; column 4 line 37 to column 5 line 2).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gibbs et al. and Stone et al. by using the method of Gibbs et al. to treat patients with neurodegenerative conditions such as infantile spinal muscular atrophy or juvenile spinal muscular atrophy (i.e., tauopathies, dementia-associated tauopathies), with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so because Gibbs et al. teaches treatment of neurodegenerative conditions in general with an adrenoceptor antagonist such as SB-269,970 or mianserin, and infantile spinal muscular atrophy and juvenile spinal muscular atrophy, as well as Alzheimer’s disease, Huntington’s disease, and Parkinson’s disease, are all neurodegenerative conditions known to be treated with adrenoceptor antagonists per Stone et al.
Regarding claim 7, since the claimed compound and the compound of Gibbs et al., are identical as discussed above, they necessarily result in identical properties (i.e., the properties are inherent), including the claimed property of prevention of both receptor-induced phosphorylation and accumulation of Tau proteins when administered, given that compositions that are physically the same must have the same properties per MPEP 2112.01(II), and thus must produce the same results when administered, and also given that the method of Gibbs et al. in view of Stone et al. is the same as the clamed method.
Regarding claims 13-19, although such claims further limit particular substituents in formulas (I)-(VI), they do not specify that the claimed method must comprise any particular formula (I)-(VI), and Gibbs et al. discloses a compound of formula (I) as discussed above. Regarding claim 13, the SB-269,970 of Gibbs et al. has R1 as methyl. Regarding claim 14, although the claim further limits the optional substituent, it does not specify that R1 must have such substituent, but nevertheless the SB-269,970 of Gibbs et al. has a meta-substituent at A as claimed.
Response to Arguments
Applicant's arguments regarding obviousness filed 11 September 2025 have been fully considered but they are not persuasive.
Applicant argues that Gibbs et al. and Tagliati et al. fail to teach or suggest a method a structure according to formula (I) or (V) that is not used for treating the conditions excluded by the claims (remarks page 11). In response, Johnson, II et al. and Stone et al. are cited to remedy such deficiency as discussed above.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached on (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617