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 .
Status of Claims
Claims 1-2, 4-15 and 17-22 are pending in the instant application. Claims 1, 4-7, 11 and 17 are amended, claims 21-22 are added and claims 3 and 16 are cancelled via the amendment filed May 23rd, 2026.
Priority
This application claims priority to 63/504,431, filed May 25th, 2023 and 63/385,896, filed December 2nd, 2022.
Information Disclosure Statement
The Information Disclosure Statements (IDS) dated 04/07/2026, 05/23/2026 and 06/23/2026 were considered by the Examiner.
Withdrawn Objections
Applicant’s arguments and amendments, filed May 23rd, 2026, with respect to objection of claim 1 have been fully considered and are persuasive. The objection of claim 1 has been withdrawn.
Applicant has overcome this objection by amending claim 1 to spell out the first abbreviation of alpha 7 nAChR.
Withdrawn Rejections
Applicant’s arguments and amendments, filed May 23rd, 2026, with respect to the 112(a) rejection of claims 1-2, 8-15 and 18-20 have been fully considered and are persuasive. The 112(a) rejection of claims 1-2, 8-15 and 18-20 has been withdrawn.
Applicant has overcome this rejection by amending claim 1 to recite “wherein the α7 nAChR modulator is (R)-3-(6-p-tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane or a pharmaceutically acceptable salt thereof.”
Applicant’s arguments and amendments, filed May 23rd, 2026, with respect to the 112(b) rejection of claim 11 have been fully considered and are persuasive. The 112(b) rejection of claim 11 has been withdrawn.
Applicant has overcome this rejection by providing clarification that the claim is in proper Jepson claim format.
Applicant’s arguments and amendments, filed May 23rd, 2026, with respect to the 35 U.S.C. 102 rejection of claims 1-3 and 8 have been fully considered and are persuasive. The 35 U.S.C. 102 rejection of claims 1-3 and 8 has been withdrawn.
Applicant has overcome this rejection by amending claim 1 to recite that the modulator is administered as a monotherapy.
Applicant’s arguments and amendments, filed May 23rd, 2026, with respect to the 35 U.S.C. 103 rejection of claims 1-20 have been fully considered and are persuasive. The 35 U.S.C. 103 rejection of claims 1-20 has been withdrawn.
Applicant has overcome this rejection by amending claims 1 and 11 to recite that the modulator is administered as a monotherapy.
Applicant’s arguments and amendments, filed May 23rd, 2026, with respect to the double patenting rejection of claims 1-20 have been fully considered and are persuasive. The double patenting rejection of claims 1-20 has been withdrawn.
Applicant has overcome this rejection by amending claims 1 and 11 to recite that the modulator is administered as a monotherapy.
Response to Remarks
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
New 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) 1-2 and 5-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Trinius et al (EP 2 742 940 A1, published June 18th, 2014, as cited on the IDS dated December 4th, 2023), as nessecitated by Applicant’s amendments.
Regarding claims 1-2, Trinius teaches the administration of (R)-3-(6-(4-methylphenyl)-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane for use in the treatment of general anxiety disorder (claim 4).
Regarding claims 5-7, Trinius teaches that the dosage of the drug is 5mg, 10mg or 20mg (claim 126).
Regarding claim 8, Trinius teaches that the drug is administered as a capsule with an excipient to be administered orally (paragraph [0051])
New 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.
Claim(s) 1-2, 4-9, 11, 14-15 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trinius et al (EP 2 742 940 A1, published June 18th, 2014, as cited on the IDS dated December 4th, 2023) in view of Stein et al (Lancet. 2008 Mar 29;371(9618):1115-25), as necessitated by Applicant’s amendment.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Regarding claims 1-2, Trinius teaches the administration of (R)-3-(6-(4-methylphenyl)-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane for use in the treatment of general anxiety disorder (claim 4).
Regarding claims 5-7, Trinius teaches that the dosage of the drug is 5mg, 10mg or 20mg (claim 126).
Regarding claim 8, Trinius teaches that the drug is administered as a capsule with an excipient to be administered orally (paragraph [0051])
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art is deemed to anticipate instant claims 1-2 and 5-8 where anticipation is the epitome of obviousness. In re Pearson, 494 F.2d 1399, 1402 (CCPA 1974)).
The prior art also does not specify the exact type of acute anxiety to be treated or that the patient is a female.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding claim 4, one of ordinary skill in the art would have been motivated by these teachings to optimize the dosage amounts of (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane. See MPEP 2144.05:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is 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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“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) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was “unexpectedly good”); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying “the need for caution in granting a patent based on the combination of elements found in the prior art.”).
As for the limitations concerning the specific type of anxiety and gender of the patient, Stein teaches that social anxiety is the most common anxiety disorder (abstract). Stein also teaches that the lifetime prevalence of social anxiety disorder is 12.1%, with higher prevalence in females (page 1115, right column, paragraph 2).
Regarding claims 9-11 and 14, as Trinius teaches a method of treating anxiety with a nicotinic acetylcholine alpha 7 receptor agonist, one of ordinary skill in the art would have been motivated to alter the method to include females with social anxiety disorder as Stein teaches that social anxiety is the most common anxiety disorder and that it has a higher prevalence in females.
Regarding claim 15, as seen above, Trinius teaches that the α7 nAChR modulator is a nicotinic acetylcholine alpha 7 receptor agonist.
As such regarding claims 17 and 20, one of ordinary skill in the art would have been motivated by these teachings to optimize the dosage amounts of (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane.
Regarding claim 18, Trinius teaches that the preferred route of administration is orally, in capsules (paragraph [0015]-[0016]).
Regarding claim 19, Stein teaches that individuals with social anxiety experience symptoms such as heart racing, sweating and trembling (page 115, left column, paragraph 2). Trinius is silent regarding " heart racing, sweating and trembling". However: "heart racing, sweating and trembling " will inevitably flow from the teachings of the prior art (see above rejection), since the same compound ((R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane) is being administered to the same subjects (a subject suffering from social anxiety). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding heart racing, sweating and trembling ", by practicing the method taught by the prior art: "the administration of (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane to a patient suffering from social anxiety", one will also be " art racing, sweating and trembling,” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage (“heart racing, sweating and trembling ") of the method taught by the prior art ("the administration of (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane to a patient suffering from social anxiety").
MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Claim(s) 1-2, 4-15 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable Trinius et al (EP 2 742 940 A1, published June 18th, 2014, as cited on the IDS dated December 4th, 2023) in view of Stein et al (Lancet. 2008 Mar 29;371(9618):1115-25), as applied to claims 1-11 and 14-20 above, and in further view of Melaragno et al (Focus Vol. 19, No. 2, Spring 2021), as necessitated by Applicant’s amendment.
The 103 rejection of claims 1-2, 4-9, 11, 14-15 and 17-20 over Trinius and Stein is incorporated herein by reference.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Neither Trinius nor Stein explicitly teach that (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane is to be administered about 2 hours prior to the individual experiencing an acute anxiety-inducing setting. Trinius does teach that the compound can be administered at difference time intervals (paragraph [0084]).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not explicitly teach that (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane is to be administered about 2 hours prior to the individual experiencing an acute anxiety-inducing setting.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, Melaragno teaches that medications to be used in social anxiety disorder treatment should be administered 1-2 hours before a situation (page 154, right column, paragraph 2).
Regarding claims 12-13, as Trinius teaches that (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane can be administered at different times during the course of therapy, one of ordinary skill in the art would have been motivated to administer (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane 2 hours before an anxiety inducing situation as Melaragno teaches that medications to be used in treatment of a social anxiety disorder should be administered 1-2 hours before an anxiety inducing situation.
New 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 1-2, 4-15 and 17-20 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6, 8, 10-17, 19, 21-22, 24-25 and 70-71 of copending Application No. 18/249,920 (reference application) in view of Trinius et al (EP 2 742 940 A1, published June 18th, 2014, as cited on the IDS dated December 4th, 2023), Stein et al (Lancet. 2008 Mar 29;371(9618):1115-25) and Melaragno et al (Focus Vol. 19, No. 2, Spring 2021).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending application claims a method of treatment of an individual suffering from public speaking anxiety or a symptom thereof, the method comprising administering to the individual (R)-3-(6-p-Tolyl-pyridin-3-yloxy)-1-aza-bicyclo[2.2.2]octane (claim 1). The copending application also claims that the individual suffers from public speaking anxiety as presenting symptom of social anxiety disorder (claim 2). The copending application also claims dosage amounts for the compounds (Claims 21-22). The instant claims are deemed to be variants of the subject matter of copending Application No. 18/249,920 for the same reasons as under 35 USC 103.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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.
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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