94Notice 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 and Status of Claims
1. This application claims benefit the provisional application:
63434994 with a filing date 12/23/2022.
2. Applicant’s remarks filed on 4/29/2026 are acknowledged. Claims 1-8 are pending in the application.
Responses to Election/Restriction
3. Applicant’s election with traverse of Group I claim 1-3, in the reply filed on April 29, 2026 is acknowledged. Election of a compound TTA009, i.e., 1-cyclobutylpropan-2-yl) [2-(6-fluoro-1H-indole-3-yl)ethyl]amine is also acknowledged. The traversal is on the ground(s) that Compound TTA009 is structurally similar to the other compounds recited in claim 1, forms part of an inventive concept, and could be efficiently searched simultaneously.
This is found not persuasive, and the reasons are given infra.
Claims 1-8 are pending in the application.
The scope of the invention of the elected subject matter is as follows.
Claims 1-3, are drawn to a product composition thereof, and are prosecuted in the case.
The above-mentioned withdrawn invention Group II-III claims 4-8 in the invention which are withdrawn from consideration as being for non-elected subject matter differ
materially in structure and composition from the compounds of the elected invention.
Groups I and III are related as product and process of use. The inventions
can be shown to be distinct if either or both of the following can be shown: (1) the
process for using the product as claimed can be practiced with another materially
different product or (2) the product as claimed can be used in a materially
different process of using that product (MPEP § 806.05(h)). In the instant case,
the process for using the product as claimed can be practiced with another
materially different product such as 5-HT2A inverse agonist lisuride of Olney et al. US 5,902,815, see column 32.
The group set forth in the claims includes both independent and distinct
inventions, and patentably distinct compounds (or species) within each invention.
However, this application discloses and claims a plurality of patentably distinct
inventions far too numerous to list individually. Moreover, each of these inventions
contains a plurality of patentably distinct compounds, also far too numerous to list
individually. Moreover, the examiner must perform a commercial database search on
the subject matter of each group in addition to a paper search, which is quite
burdensome to the examiner.
Claims 1-3, are drawn toa product composition thereof, and are prosecuted in the case.
Claims 4-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.
The requirement is still deemed proper and therefore is made FINAL.
4. 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.
Claim Rejections - 35 USC § 102
5. 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 1 is rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Shinde et
al. CAS: 175:107102, 2021, and Mueller et al. US 5,684,014.
Applicants claim a therapeutically effective composition comprising [1-(1H-indol-3-yl)propan-2-yl][2-(oxolan-3-yl)ethyl]amine (TTA005); (1-cyclobutylpropan-2-yl)[2-(6-fluoro-1H-indol-3-yl)ethyl]amine (TTA009); [2-(6-fluoro-1H-indol-3-yl)ethyl](3-methylhexan-2-yl)amine (TTA011); [2-(6-fluoro-1H-indol-3-yl)ethyl](5-methylhexan-2-yl)amine (TTA012); [1-(5-fluoro-1H-indol-3-yl)propan-2-yl][(2R)-2-hydroxy-3-methoxypropyl]amine (TTA015); 1-{[4-(1H-indol-3-yl)-4-methylpentan-2-yl]amino}-3-methylbutan-2-ol (TTA0-19); 2-{[2-(5-fluoro-1H-indol-3-yl)ethyl]amino}propan-1-ol (TTA020); 2-{[1-(5-fluoro-1H-indol-3-yl)propan-2-yl]amino}-N-(prop-2-en-1-yl)propenamide (TTA024); 3-{[1-(5-fluoro-1H-indol-3-yl)propan-2-yl]amino}butan-2-ol (TTA031); (4-cyclopropylbutan-2-yl)[2-(6-fluoro-1H-indol-3-yl)ethyl]amine (TTA033); (4,4-dimethylhexan-3-yl)[2-(6-fluoro-1H-indol-3-yl)ethyl]amine (TTA035); (1-ethoxypropan-2-yl)[2-(6-fluoro-1H-indol-3-yl)ethyl]amine (TTA036); 2-{[1-(5-fluoro-1H-indol-3-yl)propan-2-yl]amino}-N-(prop-2-yn-1-yl)propenamide (TTA037); 3-{[2-(6-fluoro-1H-indol-3-yl)ethyl]amino}-2-methylbutan-2-ol (TTA038); [1-(1H-indol-3-yl)propan-2-yl][1-(thiophen-3-yl)ethyl]amine (TTA039), ligands TTM001, TTM002, TTM003, TTM004, TTM005, TTM006, TTM009, TTM013, TTM017, TTM019, TTM024, TTM028, TTM034, TTM038, TTM041, TTM045, TTM048, TTM057, TTM059, TTM068, TTM082, their pharmaceutically acceptable salts, or diastereomers thereof, see claim 1.
Shinder et al. ‘102 discloses a composition comprising N-Desmethyl ivabradine (i.e. RN: 215935-23-2 or instant compound TTM003).
Mueller et al. ‘014 discloses a composition comprising a compound, i.e.,
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(i.e., TM0041), see column 126.
Shinder et al. ‘102 and Mueller et al. ‘014 clearly anticipate the instant composition comprising TTM003 or TTM041.
Claim Rejections - 35 USC § 103
6. The following is a quotation of 35 U.S.C. 103(a) 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-3 are rejected under 35 U.S.C. 103(a) as being obvious over
Mueller et al. US 5,684,014.
Applicants claim a Applicants claim a therapeutically effective composition comprising [1-(1H-indol-3-yl)propan-2-yl][2-(oxolan-3-yl)ethyl]amine (TTA005); (1-cyclobutylpropan-2-yl)[2-(6-fluoro-1H-indol-3-yl)ethyl]amine (TTA009); [2-(6-fluoro-1H-indol-3-yl)ethyl](3-methylhexan-2-yl)amine (TTA011); [2-(6-fluoro-1H-indol-3-yl)ethyl](5-methylhexan-2-yl)amine (TTA012); [1-(5-fluoro-1H-indol-3-yl)propan-2-yl][(2R)-2-hydroxy-3-methoxypropyl]amine (TTA015); 1-{[4-(1H-indol-3-yl)-4-methylpentan-2-yl]amino}-3-methylbutan-2-ol (TTA0-19); 2-{[2-(5-fluoro-1H-indol-3-yl)ethyl]amino}propan-1-ol (TTA020); 2-{[1-(5-fluoro-1H-indol-3-yl)propan-2-yl]amino}-N-(prop-2-en-1-yl)propenamide (TTA024); 3-{[1-(5-fluoro-1H-indol-3-yl)propan-2-yl]amino}butan-2-ol (TTA031); (4-cyclopropylbutan-2-yl)[2-(6-fluoro-1H-indol-3-yl)ethyl]amine (TTA033); (4,4-dimethylhexan-3-yl)[2-(6-fluoro-1H-indol-3-yl)ethyl]amine (TTA035); (1-ethoxypropan-2-yl)[2-(6-fluoro-1H-indol-3-yl)ethyl]amine (TTA036); 2-{[1-(5-fluoro-1H-indol-3-yl)propan-2-yl]amino}-N-(prop-2-yn-1-yl)propenamide (TTA037); 3-{[2-(6-fluoro-1H-indol-3-yl)ethyl]amino}-2-methylbutan-2-ol (TTA038); [1-(1H-indol-3-yl)propan-2-yl][1-(thiophen-3-yl)ethyl]amine (TTA039), ligands TTM001, TTM002, TTM003, TTM004, TTM005, TTM006, TTM009, TTM013, TTM017, TTM019, TTM024, TTM028, TTM034, TTM038, TTM041, TTM045, TTM048, TTM057, TTM059, TTM068, TTM082, their pharmaceutically acceptable salts, or diastereomers thereof, see claim 1.
Dependent claims further limit the scope of compositions, i.e., specific compounds including TTA039 or TTA009.
Determination of the scope and content of the prior art (MPEP §2141.01)
Muller et al. ‘014 discloses a compound/composition comprising a compound of formula (I),
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, wherein R1 and R2 including the double bond connecting them, together form a phenyl or pyridyl ring, R3 and R4 including the double bond connecting them, together form a phenyl ring or a 4- to 8-membered cycloalkene or oxocycloalkene radical, D is hydrogen or cycloalkyl, E is
-CO-,L is NR9 and R9 is hydrogen or alkyl, and R5-R7 represent phenyl,hydrogen, carboxyl or alkyl, see columns 1-2.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Muller et al. ‘014 is that the instant
claims are embraced within the scope of Muller et al. ‘014.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 1-3 prima facie obvious because one would be motivated to employ the compound/composition of Muller et al. ‘014 to obtain instant invention.
The motivation to make the claimed compounds/compositions derived from the known compound/composition of Muller et al. ‘014 would possess similar activity to that which is claimed in the reference.
Conclusion
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to REI TSANG SHIAO whose telephone number is
(571)272-0707. The examiner can normally be reached on 8:30 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached on 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
August 10, 2026
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