DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 47-69 are pending in the instant invention. According to the Amendments to the Claims, filed May 26, 2026, claims 47, 53 and 54 were amended, claims 1-46 were cancelled and claims 67-69 were added.
Status of Priority
This invention is a Continuation (CON) of US Application No. 19/402,111, filed November 26, 2025, which is Continuation (CON) of abandoned US Application No. 19/183,730, filed April 18, 2025, which is Continuation (CON) of abandoned US Application No. 18/899,468, filed September 27, 2024, which is Continuation (CON) of abandoned US Application No. 18/051,439, filed October 31, 2022, which claims priority under 35 U.S.C. § 119(e) to US Provisional Application Nos.: a) 63/407,521, filed September 16, 2022; b) 63/390,834, filed July 20, 2022; c) 63/306,935, filed February 4, 2022; d) 63/278,419, filed November 11, 2021; and e) 63/273,697, filed October 29, 2021.
Although the inventor’s or joint inventor’s claim for the benefit of a prior-filed invention under 35 U.S.C. § 119(e) is acknowledged, the inventor or joint inventor has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. § 119(e) as follows:
The later-filed invention must be an invention for a patent, for an invention which is also disclosed in the prior-filed inventions (the provisional inventions). The disclosure of the invention in the prior-filed inventions and in the later-filed invention must be sufficient to comply with the requirements of 35 U.S.C. § 112(a). {See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)}.
The specifications of the prior-filed inventions, US Provisional Application Nos.: a) 63/390,834; b) 63/306,935; c) 63/278,419; and d) 63/273,697, respectively, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. § 112(a) for one or more claims of this invention for the following reason: the specification in the instant invention has been amended with respect to at least the proviso with respect to R2, and is no longer coextensive with that of US Provisional Application Nos.: a) 63/390,834; b) 63/306,935; c) 63/278,419; and d) 63/273,697, respectively.
Consequently, since the specifications of US Provisional Application Nos.: a) 63/390,834; b) 63/306,935; c) 63/278,419; and d) 63/273,697, respectively, lack adequate support or enablement for one or more claims of the elected invention of Group II, as defined below in Restrictions / Election of Species, and in the manner provided by 35 U.S.C. § 112(a), the first Office action on the merits of all relevant claims drawn to Group II will be prosecuted according to the earliest effective filing date afforded this invention, which is that of US Provisional Application No. 63/407,521, filed September 16, 2022.
Restrictions / Election of Species
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The inventor’s or joint inventor’s provisional election of the following, without traverse, in the reply filed on May 26, 2026, is acknowledged: a) Group II - claims 47-64 and 67-69; and b) substituted indole of Formula IV - p. 72, compound 152, shown to the right below, and hereafter referred to as (2R)-1,1,1,2,3,3-hexadeutero-3-[5-(trideuteromethoxy)indol-1-yl]-N,N-bis(trideuteriomethyl)propan-2-amine, where each Rc = -CD3; R1 = -CD3; Y1 = -D; Y2 = -D; Y3 = -D; Y4 = -H; Y5 = -H; Y6 = -H; Y7 = -OR2, wherein R2 = -CD3; Y8 = -H; and Y9 = -D. Claims 47-52, 55, 56, 58-60, 62-64 and 67-69 read on the elected species. Affirmation of this election must be made by the inventor or joint inventor in replying to this Office action.
Similarly, the inventor or joint inventor should further note that the requirement is still deemed proper and is therefore made FINAL.
Likewise, the inventor or joint inventor should further note that the elected species, shown to the right above, was not found to be free of the prior art.
Moreover, the inventor or joint inventor should further note that claims 65 and 66 were withdrawn from further consideration, pursuant to 37 CFR 1.142(b), as being drawn to a nonelected or cancelled invention, there being no allowable generic or linking claim.
Thus, a first Office action and prosecution on the merits of claims 47-64 and 67-69 is contained within.
Specification Objection - Disclosure
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(c). Revisions should particularly address bold-type, underline, and/or upper case formatting. Appropriate correction may be required.
Claim Objections
Claim 47 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), the existing recitation should be replaced with the following recitation:
A compound of Formula IV:
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Formula IV
or a pharmaceutically acceptable salt or stereoisomer thereof,
wherein:
each Rc is independently CH3 or CD3;
R1 is CH3 or CD3;
Y1 is H, D, CH3, or CD3;
Y2 is H or D;
Y3 is H or D;
Y4 is H or D;
Y5 is H or D;
Y6 is H or D;
Y7 is OR2;
R2 is CH3 or CD3;
Y8 is H or D; and
Y9 is H or D;
with the provisos that:
1) if R2 is CH3, then at least one of Y1, Y2, Y3, Y4, Y5, Y8, and Y9 is D; and
2) if R2 is CH3, then R1 is CD3.
Appropriate correction is required. See MPEP § 2173.02.
Claim 48 is objected to because of the following informalities: for clarity and precision, the claim is dependent upon a rejected base claim. Appropriate correction is required. See MPEP § 2173.02.
Claim 49 is objected to because of the following informalities: for clarity and precision, the claim is dependent upon a rejected base claim. Appropriate correction is required. See MPEP § 2173.02.
Claim 50 is objected to because of the following informalities: for clarity and precision, the claim is dependent upon a rejected base claim. Appropriate correction is required. See MPEP § 2173.02.
Claim 52 is objected to because of the following informalities: for clarity and precision, the claim is dependent upon a rejected base claim. Appropriate correction is required. See MPEP § 2173.02.
Claim 53 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 47, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein:
Y4 is H;
Y5 is H;
Y6 is H;
Y7 is OCH3;
Y8 is H; and
Y9 is H.
Appropriate correction is required. See MPEP § 2173.02.
Claim 54 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 52, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein:
Y4 is H;
Y5 is H;
Y6 is H;
Y7 is OCH3;
Y8 is H; and
Y9 is H.
Appropriate correction is required. See MPEP § 2173.02.
Claim 55 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 47, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein each Rc is independently CD3.
Appropriate correction is required. See MPEP § 2173.02.
Claim 56 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 52, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein each Rc is independently CD3.
Appropriate correction is required. See MPEP § 2173.02.
Claim 57 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 54, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein each Rc is independently CD3.
Appropriate correction is required. See MPEP § 2173.02.
Claim 58 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 47, or a stereoisomer thereof, wherein the compound, or stereoisomer thereof, is selected from the group consisting of:
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, and
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or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 59 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 47, or a stereoisomer thereof, wherein the compound, or stereoisomer thereof, is selected from the group consisting of:
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, and
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or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 60 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 47, or a stereoisomer thereof, wherein the compound, or stereoisomer thereof, is selected from the group consisting of:
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or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 61 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A compound selected from the group consisting of:
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and
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or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 62 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A compound selected from the group consisting of:
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and
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or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 63 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a compound of claim 47, or a pharmaceutically acceptable salt or stereoisomer thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 64 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a compound of claim 60, or a pharmaceutically acceptable salt or stereoisomer thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 67 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 47, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein:
Y4 is H;
Y5 is H;
Y6 is H;
Y7 is OCD3;
Y8 is H; and
Y9 is H.
Appropriate correction is required. See MPEP § 2173.02.
Claim 68 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 52, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein:
Y4 is H;
Y5 is H;
Y6 is H;
Y7 is OCD3;
Y8 is H; and
Y9 is H.
Appropriate correction is required. See MPEP § 2173.02.
Claim 69 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound of claim 68, or a pharmaceutically acceptable salt or stereoisomer thereof, wherein each Rc is independently CD3.
Appropriate correction is required. See MPEP § 2173.02.
Claim Rejections - 35 U.S.C. § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. § 112:
(a) IN GENERAL. The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Substituted indoles of the Formula IV
Claim 47 is rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or joint inventor, at the time the invention was filed, had possession of the claimed invention. Specifically, the proviso with respect to the substituted indoles of the Formula IV, wherein at least one of Y1, Y2, and Y3 is D, and/or R1 is CD3, lacks adequate support within the original specification, as filed. The specification, on page 7, discloses generic substituted indoles of the Formula IV, which expressly includes substituted indoles of the Formula IV, wherein when R2 is CH3, then at least one of Y1, Y2, Y3, Y4, Y5, Y8, and Y9 is D, or R1 is CD3. Consequently, one of ordinary skill in the art, at the time this invention was filed, may neither be reasonably apprised of the scope of the instantly recited substituted indoles of the Formula IV, nor recognize that the inventor or joint inventor was in possession of the instantly recited substituted indoles of the Formula IV, in view of the original specification of the invention.
The inventor or joint inventor should note that under 35 U.S.C. § 132 and 35 U.S.C. § 251, the proscription against the introduction of new matter in a patent invention serves to prevent an inventor or joint inventor from adding information that goes beyond the subject matter originally filed. {See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981); and MPEP § 2163.06-2183.07}.
Similarly, the inventor or joint inventor should further note that in order to comply with the written description requirement of 35 U.S.C. § 112(a), each claim limitation must be expressly, implicitly, or inherently supported in the originally filed specification. [W]hen an explicit limitation in a claim is not present in the written description whose benefit is sought, it must be shown that a person of ordinary skill would have understood, at the time the patent invention was filed, that the description requires that limitation. {See Hyatt v. Boone, 146 F.3d 1348, 1353, 47 USPQ2d 1128, 1131 (Fed. Cir. 1998); and In re Wright, 866 F.2d 422, 425, 9 USPQ2d 1649, 1651 (Fed. Cir. 1989)}.
Likewise, the inventor or joint inventor should further note that any negative limitation or exclusionary proviso must also have basis in the original specification. See MPEP § 2173.05(i).
Consequently, the inventor or joint inventor should further note that [N]ew or amended claims, which introduce elements or limitations which are not supported by the as-filed disclosure, violate the written description requirement. {See In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971); and In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972)}.
Also, the inventor or joint inventor should further note that when filing an amendment, support should be shown in the original specification for new or amended claims. See MPEP § 714.02 and § 2163.06.
The examiner suggests amending the claim, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim Rejections - 35 U.S.C. § 103
The following is a quotation of the appropriate paragraphs 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 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 nonobviousness.
Claims 47, 51, 53 and 63 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Olson, et al. in WO 20/176597.
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The inventor or joint inventor should note that the instant invention recites a substituted indole of the Formula IV, shown to the left, where each Rc = -CH3; R1 = -CD3; Y1 = -H; Y2 = -H; Y3 = -H; Y4 = -H; Y5 = -H; Y6 = -H; Y7 = -OR2, wherein R2 = -CH3; Y8 = -H; and Y9 = -H, respectively, and/or a pharmaceutical composition thereof, as a 5-hydroxytryptamine (5-HT) serotonin receptor agonist and/or antagonist.
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Similarly, the inventor or joint inventor should further note that Olson, et al. (WO 20/176597), as provided in the file and cited on the IDS, teaches a substituted indole, shown to the right, where at each Rc = -CH3; R1 = -CH3; Y1 = -H; Y2 = -H; Y3 = -H; Y4 = -H; Y5 = -H; Y6 = -H; Y7 = -OR2, wherein R2 = -CH3; Y8 = -H; and Y9 = -H, respectively, and/or a pharmaceutical composition thereof, as a 5-hydroxytryptamine (5-HT) serotonin receptor agonist and/or antagonist {p. 36, ¶[0112]; p. 95, Example 59; and pharmaceutical compositions - p. 5, ¶[0009]}.
Likewise, the inventor or joint inventor should further note that in the genus disclosure, Olson teaches that -CD3 and -CH3 are alternatively usable at R1 [for R1, see The present invention also includes isotopically labeled compounds of the present invention, wherein one or more atoms are replaced by one or more atoms having specific atomic mass or mass numbers. Examples of isotopes that can be incorporated into compounds of the invention include, but are not limited to, isotopes of hydrogen,… (such as 2H, 3H,…). {p. 47, ¶[0130]}.
Next, the inventor or joint inventor should further note that the only difference between the instantly recited substituted indole of the Formula IV, and/or pharmaceutical composition thereof, and Olson’s substituted indole, and/or pharmaceutical composition thereof, is R1 is -CD3 in the instantly recited substituted indole of the Formula IV, and/or pharmaceutical composition thereof, whereas R1 is -CH3 in Olson’s substituted indole, and/or pharmaceutical composition thereof.
Then, the inventor or joint inventor should further note that in the chemical arts, it is widely accepted that [S]tructural similarity between claimed and prior art subject matter, proved by combining references or otherwise, where the prior art gives reason or motivation to make the claimed compositions or compounds, creates a prima facie case of obviousness. {See Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., No. 06-1329, slip op. at 9 (Fed. Cir. June 28, 2007) (quoting In re Dillon, 919 F.2d 688, 692 [16 USPQ2d 1897] (Fed. Cir. 1990) (en banc)); and In re Papesch, 315 F.2d 381 [137 USPQ 43] (C.C.P.A. 1963)}.
Consequently, the inventor or joint inventor should further note that since: a) Olson teaches a substituted indole, where R1 is -CH3, and/or a pharmaceutical composition thereof; b) Olson teaches a substituted indole, where -CD3 and -CH3 are alternatively usable at R1, and/or a pharmaceutical composition thereof; and c) the courts have recognized that [S]tructural similarity between claimed and prior art subject matter, proved by combining references or otherwise, where the prior art gives reason or motivation to make the claimed compositions or compounds, creates a prima facie case of obviousness, one having ordinary skill in the art, before the effective filing date of the recited invention, would have been motivated to utilize the teachings of Olson and replace the -CH3 at R1 in Olson’s substituted indole, with an alternatively usable -CD3, and/or formulate a pharmaceutical composition thereof, with a reasonable expectation of success and similar therapeutic activity, rendering claims 47, 51, 53 and 63 obvious.
Moreover, the inventor or joint inventor should also note that this invention 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 as of the effective filing date of the claimed invention, absent any evidence to the contrary. The inventor or joint inventor 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.
Also, the inventor or joint inventor should further note that in the event the determination of the status of the invention as subject to AIA 35 U.S.C. § 103 (or as subject to pre-AIA 35 U.S.C. § 103) is incorrect, any correction of the statutory basis for the instant 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.
Allowable Subject Matter
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The examiner is also available on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624
Prosecution Insights