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 1-9, 15, 17, 18, 20, 24-28, 36, 37, 45 and 46 are pending in the instant invention. According to the Amendments to the Claims, filed April 22, 2026, claims 1-4, 15 and 17 were amended, claims 10-14, 16, 19, 21-23, 29-35 and 38-44 were cancelled and claims 45 and 46 were added.
Status of Priority
This invention is a Continuation (CON) of International Application No. PCT/EP2021/081081, filed November 9, 2021, which claims priority under 35 U.S.C. § 119(e) to US Provisional Application No. 63/112,498, filed November 11, 2020.
Status of Restrictions / Election of Species
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The inventor’s or joint inventor’s affirmation of the following election, with traverse, in the reply filed on April 22, 2026, is acknowledged: a) Group I - claims 1-4, 15, 17, 45 and 46; and b) substituted pyrrolo[3,2-c]pyridine of formula (I) - pp. 109-110, Example 2.
Similarly, the inventor or joint inventor should further note that the requirement was made FINAL in the Non-Final Rejection, mailed on January 22, 2026.
Likewise, the inventor or joint inventor should further note that this invention contains claims 5-9, 18, 20, 24-28, 36 and 37, drawn to nonelected inventions, with traverse, in the reply filed on April 22, 2026. A complete reply to the Final Rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144). See MPEP § 821.01.
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 January 22, 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should further note that any rejections and/or objections of record not explicitly addressed herein below, are hereby withdrawn, in light of the inventor’s or joint inventor’s arguments and/or the Amendments to the Claims, filed April 22, 2026.
Thus, a second Office action and prosecution on the merits of claims 1-4, 15, 17, 45 and 46 is contained within.
New Claim Objections
Claim 1 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 (I):
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(I)
or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof,
wherein:
R1 represents H, Cl, Br, CN, CH3, CF3, CH2CH3, CH2CHF2, OCH3, or OCHF2;
R2 represents H, F, Cl, Br, CH3, or CH2CH3;
R3 represents H or F;
R4 represents H, CH3, or CF3;
R5 represents H, CH3, or CF3; or
R4 and R5, together with the carbon atom to which they are attached, represent a C3-C6 cycloalkyl;
R6 represents:
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,
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, or
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; and
R7 represents H or CH3.
Appropriate correction is required. See MPEP § 2173.02.
Claim 2 is objected to because of the following informalities: for brevity, clarity and precision, the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein:
R1 represents H, CH3, OCH3, or OCHF2;
R2 represents H, F, or Cl;
R4 represents H or CH3;
R5 represents H or CH3; or
R4 and R5, together with the carbon atom to which they are attached, represent a C3-C5 cycloalkyl; and
R6 represents:
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,
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, or
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.
Appropriate correction is required. See MPEP § 2173.02.
Claim 3 is objected to because of the following informalities: for brevity, clarity and precision, the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, wherein:
R1 represents CH3, OCH3, or OCHF2;
R2 represents H, F, or Cl;
R3 represents H;
R4 represents H or CH3;
R5 represents H or CH3; or
R4 and R5, together with the carbon atom to which they are attached, represent a cyclobutyl; and
R6 represents:
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, or
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.
Appropriate correction is required. See MPEP § 2173.02.
Claim 4 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a stereoisomer thereof, wherein the compound, or stereoisomer thereof, is selected from the group consisting of:
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, ,
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and
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or a pharmaceutically acceptable salt or tautomer thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 15 is objected to because of the following informalities: for brevity, clarity and precision, the existing recitation should be replaced with the following recitation:
A pharmaceutical composition comprising at least one pharmaceutically acceptable auxiliary together with at least one compound according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 17 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
A combination comprising at least one compound according to claim 1, or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof, and at least one additional active ingredient selected from the group consisting of a chemotherapeutic anti-cancer agent and a target-specific anti-cancer agent.
Appropriate correction is required. See MPEP § 2173.02.
Claim 45 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 (I):
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(I)
or a pharmaceutically acceptable salt, stereoisomer, or tautomer thereof,
wherein:
R1 represents H, Cl, Br, CN, CF3, CH2CH3, CH2CHF2, OCH3, or OCHF2;
R2 represents H, F, Cl, Br, CH3, or CH2CH3;
R3 represents H or F;
R4 represents H, CH3, or CF3;
R5 represents H, CH3, or CF3; or
R4 and R5, together with the carbon atom to which they are attached, represent a C3-C6 cycloalkyl;
R6 represents:
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; and
R7 represents H or CH3.
Appropriate correction is required. See MPEP § 2173.02.
Claim 46 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound according to claim 45, or a stereoisomer thereof, wherein the compound, or stereoisomer thereof, is:
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,
or a pharmaceutically acceptable salt or tautomer thereof.
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.
Claim 45 is rejected under 35 U.S.C. § 103(a) as being unpatentable over Milgram, et al. in US 2023/0364070.
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The inventor or joint inventor should note that the instant invention recites a substituted pyrrolo[3,2-c]pyridine of the formula (I), shown to the left, where R1 = -CH2CH3; R2 = -F; R3 = -H; R4 = -H; R5 = -H; and R6 = -CH2-(1-acryloylpyrrolidin-2-yl), respectively, as an epidermal growth factor receptor (EGFR) inhibitor.
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Similarly, the inventor or joint inventor should further note that Milgram, et al. (US 2023/0364070), as cited in the Non-Final Rejection, mailed on January 22, 2026, teaches a substituted pyrrolo[3,2-c]pyridine of the formula (I), shown to the right, where R1 = -CH3; R2 = -F; R3 = -H; R4 = -H; R5 = -H; and R6 = -CH2-(1-acryloylpyrrolidin-2-yl), respectively, as an epidermal growth factor receptor (EGFR) inhibitor {p. 60, Compound #140; p. 276, Example 9, Compound 140; 63/082324 - p. 171, Example 9, Compound 140}.
Likewise, the inventor or joint inventor should further note that in the genus disclosure, Milgram teaches that -CH2CH3 and -CH3 are alternatively usable at R1 {for R1, see Ring A is Rg ¶[0036], wherein Rg is C6-10 aryl optionally substituted with from 1-4 Rc ¶[0045] and ¶[0049], where each occurrence of Rc is… C1-10 alkyl ¶[0042]}.
Next, the inventor or joint inventor should further note that the only difference between the instantly recited substituted pyrrolo[3,2-c]pyridine of the formula (I) and Milgram’s substituted pyrrolo[3,2-c]pyridine is R1 is -CH2CH3 in the instantly recited substituted pyrrolo[3,2-c]pyridine of the formula (I), whereas R1 is -CH3 in Milgram’s substituted pyrrolo[3,2-c]pyridine.
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) Milgram teaches a substituted pyrrolo[3,2-c]pyridine, where R1 is -CH3; b) Milgram teaches a substituted pyrrolo[3,2-c]pyridine, where -CH2CH3 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 Milgram and replace the -CH3 at R1 in Milgram’s substituted pyrrolo[3,2-c]pyridine, with an alternatively usable -CH2CH3, with a reasonable expectation of success and similar therapeutic activity, rendering claim 45 obvious.
Moreover, the inventor or joint inventor should further note that, although not explicitly discussed herein, the Milgram reference contains additional species that may obviate the instantly recited substituted pyrrolo[3,2-c]pyridine of the formula (I). Consequently, any amendments to the claims and/or arguments formulated to overcome rejections rendered under 35 U.S.C. § 103(a) should address this reference as a whole and should not be limited to the species discussed or disclosed explicitly herein.
Furthermore, 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
The inventor’s or joint inventor’s arguments and/or the Amendments to the Claims, filed April 22, 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
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