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, 48, 50-59 and 63-76 are pending in the instant invention. According to the Amendments to the Claims, filed September 8, 2026, claims 47, 52-59, 63, 64, 67 and 68 were amended, claims 1-46, 49 and 60-62 were cancelled and claims 70-76 were added.
Status of Priority Objection - Priority Date
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 No. 63/407,521, filed September 16, 2022.
Similarly, the inventor or joint inventor should further note that this invention’s claim to priority under 35 U.S.C. § 119(e) to US Provisional Application Nos.: a) 63/390,834, filed July 20, 2022; b) 63/306,935, filed February 4, 2022; c) 63/278,419, filed November 11, 2021; and d) 63/273,697, filed October 29, 2021, respectively, was objected to in the Non-Final Rejection, mailed on June 9, 2026. Consequently, the effective filing date, for examination and prosecution on the merits, is that of US Provisional Application No. 63/407,521, filed September 16, 2022.
Status of Restrictions / Election of Species
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The inventor’s or joint inventor’s affirmation of the following election, without traverse, in the reply filed on September 8, 2026, is acknowledged: a) Group II - claims 47, 48, 50-59, 63, 64 and 67-76; and b) substituted indole of Formula IV - p. 72, compound 152.
Similarly, the inventor or joint inventor should further note that the requirement was made FINAL in the Non-Final Rejection, mailed on June 9, 2026.
Likewise, the inventor or joint inventor should further note that this invention contains claims 65 and 66, drawn to nonelected inventions, without traverse, in the reply filed on September 8, 2026. A complete reply to the Final Rejection may include cancellation of nonelected claims or other appropriate action (37 CFR 1.144). See MPEP § 821.02.
Next, the inventor or joint inventor should further note that the sections of U.S.C. Title 35 that formed the basis of prior rejections formulated, as well as any references supporting said rejections, that are not included with this Office action, may be found in the Non-Final Rejection, mailed on June 9, 2026.
Moreover, the inventor or joint inventor should further note that any rejections and/or objections of record not explicitly addressed herein below, are hereby withdrawn, in light of the inventor’s or joint inventor’s arguments and/or the Amendments to the Claims, filed September 8, 2026.
Thus, a second Office action and prosecution on the merits of claims 47, 48, 50-59, 63, 64 and 67-76 is contained within.
Status of Claim Rejections - 35 U.S.C. § 103
The inventor’s or joint inventor’s arguments, on page 12 of the Remarks, filed September 8, 2026, with respect to claims 47, 51, 53 and 63, have been fully considered, but are not persuasive. Consequently, the rejection of claims 47, 51, 53 and 63, made in the Non-Final Rejection, mailed on June 9, 2026, is hereby maintained for the reasons of record.
The inventor or joint inventor primarily argues that the Examiner has not articulated a reasoned explanation of why a skilled artisan would have selected the reference substituted indole of Olson from among the numerous substituted indoles disclosed in WO 20/176597 for further modification. Similarly, the inventor or joint inventor further argues that (1) the Examiner has not articulated a reasoned explanation of why a skilled artisan would have decided to modify the reference substituted indole of Olson by deuterating it with a CD3 group at position R1, and that (2) the inventor’s or joint inventor’s specification demonstrates that substituted indoles having CD₃ modification at the R1 position demonstrate increased clearance rates and shorter half-lives relative to the corresponding non-deuterated substituted indoles and, before the present invention was filed, it could not have been predicted with a reasonable expectation of success, that the instantly recited substituted indoles would possess such properties.
In response to the inventor’s or joint inventor’s argument that (1) the Examiner has not articulated a reasoned explanation of why a skilled artisan would have selected the reference substituted indole of Olson from among the numerous substituted indoles disclosed in WO 20/176597 for further modification, and that (2) the Examiner has not articulated a reasoned explanation of why a skilled artisan would have decided to modify the reference substituted indole of Olson by deuterating it with a CD3 group at position R1, the Examiner respectfully disagrees, since MPEP § 2144-I states that [T]he rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. {See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000); In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990); In re Nilssen, 851 F.2d 1401, 1403, 7 USPQ2d 1500, 1502 (Fed. Cir. 1988); Ex parte Clapp, 227 USPQ 972 (Bd. Pat. App. & Inter. 1985); and Ex parte Levengood, 28 USPQ2d 1300 (Bd. Pat. App. & Inter. 1993)}.
Likewise, the Examiner recognizes that [O]bviousness can only be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. {See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); and In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992)}.
Next, the inventor or joint inventor should note further that in the present instance, 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]}.
Then, in response to the inventor’s or joint inventor’s argument that the inventor’s or joint inventor’s specification demonstrates that substituted indoles having CD₃ modification at the R1 position demonstrate increased clearance rates and shorter half-lives relative to the corresponding non-deuterated substituted indoles and, before the present invention was filed, it could not have been predicted with a reasonable expectation of success, that the instantly recited substituted indole would possess such properties, the Examiner further respectfully disagrees, since it is noted that the feature upon which the inventor or joint inventor relies (i.e. pharmacological activity) is not recited in the rejected claims. [A]lthough the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. {See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993)}.
Moreover, the inventor or joint inventor should further note that [T]he fact that the inventor or joint inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. {See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)}.
Here, the inventor or joint inventor should further note that [A] prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. {See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963); In re Wiechert, 370 F.2d 927, 152 USPQ 247 (CCPA 1967); and In re Peterson, 65 USPQ2d 1379 (Fed. Cir. 2003)}.
Now, the inventor or joint inventor should further note that if intent is to rely on unexpected or unforeseen results, attention is invited to MPEP § 716. Absent clear, convincing, side-by-side, date-demonstrating unobviousness vis-à-vis the prior art commensurate with the scope of protection sought, the claims are considered prima facie obvious.
Furthermore, the inventor or joint inventor should also note that since arguments of counsel may not take the place of factually supported objective evidence in the record, [A]n assertion of what seems to follow from common experience, which is merely deemed as attorney argument, is not the kind of factual evidence that is required to rebut a prima facie case of obviousness. {See In re Huang, 100 F.3d 135, 139-40, 40 USPQ2d 1685, 1689 (Fed. Cir. 1996); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984); In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)}.
Also, the inventor or joint inventor should further note that rebuttal evidence may be appropriately submitted by way of an affidavit or declaration under 37 CFR 1.132.
As a result of the Amendments to the Claims, filed September 8, 2026, and to clarify the record, the original rejection, made in the Non-Final Rejection, mailed on June 9, 2026, is amended below, in the section entitled New Claim Rejections - 35 U.S.C. § 103, to omit previously rejected claim 51 and encompass new independent claim 76.
New Claim Objections
Claim 47 is objected to because of the following informalities: for clarity and precision, 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 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.
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 51 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 54 is objected to because of the following informalities: for clarity and precision, the claim is dependent upon an objected base claim. Appropriate correction is required. See MPEP § 2173.02.
Claim 55 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 56 is objected to because of the following informalities: for clarity and precision, the claim is dependent upon an objected base claim. Appropriate correction is required. See MPEP § 2173.02.
Claim 57 is objected to because of the following informalities: for clarity and precision, the claim is dependent upon an objected base claim. Appropriate correction is required. See MPEP § 2173.02.
Claim 58 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 59 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 64 is objected to because of the following informalities: for clarity and precision, the claim is dependent upon an objected base claim. Appropriate correction is required. See MPEP § 2173.02.
Claim 67 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 68 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 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 70 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 71 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 72 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 73 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 74 is objected to because of the following informalities: for clarity and precision, 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 D;
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.
Appropriate correction is required. See MPEP § 2173.02.
Claim 75 is objected to because of the following informalities: for clarity and precision, 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 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.
Appropriate correction is required. See MPEP § 2173.02.
Claim 76 is objected to because of the following informalities: for clarity and precision, 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 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.
Appropriate correction is required. See MPEP § 2173.02.
New 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, 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 = -CH3; Y1 = -H; Y2 = -D; 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 in the Non-Final Rejection, mailed on June 9, 2026, 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 -D and -H are alternatively usable at Y2 [for Y2, 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 Y2 is -D in the instantly recited substituted indole of the Formula IV, and/or pharmaceutical composition thereof, whereas Y2 is -H 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 Y2 is -H, and/or a pharmaceutical composition thereof; b) Olson teaches a substituted indole, where -D and -H are alternatively usable at Y2, 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 -H at Y2 in Olson’s substituted indole, with an alternatively usable -D, and/or formulate a pharmaceutical composition thereof, with a reasonable expectation of success and similar therapeutic activity, rendering claims 47, 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.
Claim 74 is 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 = -CH3; Y1 = -D; Y2 = -H; Y3 = -H; Y4 = -H; Y5 = -H; Y6 = -H; Y7 = -OR2, wherein R2 = -CH3; Y8 = -H; and Y9 = -H, respectively, 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 in the Non-Final Rejection, mailed on June 9, 2026, 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, as a 5-hydroxytryptamine (5-HT) serotonin receptor agonist and/or antagonist {p. 36, ¶[0112]; p. 95, Example 59}.
Likewise, the inventor or joint inventor should further note that in the genus disclosure, Olson teaches that -D and -H are alternatively usable at Y1 [for Y1, 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 Olson’s substituted indole is Y1 is -D in the instantly recited substituted indole of the Formula IV, whereas Y1 is -H in Olson’s substituted indole.
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 Y1 is -H; b) Olson teaches a substituted indole, where -D and -H are alternatively usable at Y1; 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 -H at Y1 in Olson’s substituted indole, with an alternatively usable -D, with a reasonable expectation of success and similar therapeutic activity, rendering claim 74 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.
Claim 75 is 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 = -CH3; Y1 = -H; Y2 = -H; Y3 = -D; Y4 = -H; Y5 = -H; Y6 = -H; Y7 = -OR2, wherein R2 = -CH3; Y8 = -H; and Y9 = -H, respectively, 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 in the Non-Final Rejection, mailed on June 9, 2026, 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, as a 5-hydroxytryptamine (5-HT) serotonin receptor agonist and/or antagonist {p. 36, ¶[0112]; p. 95, Example 59}.
Likewise, the inventor or joint inventor should further note that in the genus disclosure, Olson teaches that -D and -H are alternatively usable at Y3 [for Y3, 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 Olson’s substituted indole is Y3 is -D in the instantly recited substituted indole of the Formula IV, whereas Y3 is -H in Olson’s substituted indole.
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 Y3 is -H; b) Olson teaches a substituted indole, where -D and -H are alternatively usable at Y3; 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 -H at Y3 in Olson’s substituted indole, with an alternatively usable -D, with a reasonable expectation of success and similar therapeutic activity, rendering claim 75 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.
Claim 76 is 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, 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 in the Non-Final Rejection, mailed on June 9, 2026, 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, as a 5-hydroxytryptamine (5-HT) serotonin receptor agonist and/or antagonist {p. 36, ¶[0112]; p. 95, Example 59}.
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 Olson’s substituted indole is R1 is -CD3 in the instantly recited substituted indole of the Formula IV, whereas R1 is -CH3 in Olson’s substituted indole.
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; b) Olson teaches a substituted indole, where -CD3 and -CH3 are alternatively usable at R1; 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, with a reasonable expectation of success and similar therapeutic activity, rendering claim 76 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.
Finally, 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
The inventor’s or joint inventor’s arguments and/or the Amendments to the Claims, filed September 8, 2026, necessitated the new ground of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). The inventor or joint inventor 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 extension fee 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 date of this final action.
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
