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 .
Response to Amendment
The amendments received 11/18/2025 have been entered. Claims 1-7, 13, 15-16, 22-28, 34, 40, and 42 are pending. Claims 5-7, 16, 22-28, 34, 40 and 42 remain withdrawn. Any objection or rejection previously set forth in the Office Action mailed 08/18/2025 that is not maintained herein has been overcome and is withdrawn. Moreover, Examiner has considered Applicant’s arguments regarding the rejection under 35 U.S.C. 103 over WO 2016/120196 A1 and finds them persuasive. The rejection has been withdrawn. Examiner has therefore also withdrawn the nonstatutory double patenting rejection over U.S. Patent No. 10428063 B2, which is a 371 of WO 2016/120196 A1, for the same reasons. The rejections under 35 U.S.C. 103 over WO 2020/216773 A1, WO 2020/216774 A1, and WO 2020/216781 A1 have been withdrawn as the aforementioned references have been disqualified as prior art under the 35 U.S.C. 102(b)(2)(C) exception.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c). See the sequences disclosed in the specification (filed 11/18/2025) on pages 328 (line 11), 330 (line 31), 332 (line 13), 333 (line 30), and 340 (line 11).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 15 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the chemotherapeutic anti-cancer agents as listed on pages 30-32 of the specification, does not reasonably provide enablement for chemotherapeutic anti-cancer agents ant target-specific anti-cancer agents generally. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
The instant claims are drawn to pyrrolopyridinone derivatives of formula (I). The instant claims are further directed to a combination comprising a compound of formula (I) and a second active ingredient selected from chemotherapeutic anti-cancer agents and target-specific anti-cancer agents. The specification does not define that which is intended in the use of “chemotherapeutic anti-cancer agents”. Combinations of agents are generally considered in the art to be unpredictable despite a high level of skill. It is well established that "the scope of enablement varies inversely with the degree of unpredictability of the factors involved" and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
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.
Claims 1-4, 13, and 15 is/are rejected under 35 U.S.C. 103 as being obvious over Siegel et al. (WO 2019/081486 A1; published May 2019, effectively filed 2017; IDS filed 09/22/2022).
Siegel et al. discloses the following compounds (p. 233, 254, 257). See additional examples on pages 221-283.
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Siegel et al. additionally discloses pharmaceutical compositions comprising the compounds and an auxiliary (p. 48) and combinations of the compounds with anti-cancer agents (p. 58-59).
The compounds of Siegel et al. differ from those of the instant invention, wherein R3 and R4 are both hydrogen.
While the exact compounds of formula I and claim 4 are not disclosed by Siegel et al., it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 126 U.S.P.Q. 477, 53 U.S. P.Q. 40 (C.C.P.A. 1942); In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963); In re Lohr, 317 F.2d 388, 137 U.S.P.Q. 548 (C.C.P.A. 1963); In re Hoehsema, 399 F.2d 269, 158 U.S.P.Q. 598 (C.C.P.A. 1968); In re Wood, 582 F.2d 638, 199 U.S. P.Q. 137 (C.C.P.A. 1978); In re Hoke, 560 F.2d 436, 195 U.S.P.Q. 148 (C.C.PA.A. 1977); Ex parte Fauque, 121 U.S.P.Q. 425 (P.O.B.A. 1954); Ex parte Henkel, 130 U.S.P.Q. 474, (P.O.B.A. 1960). Absent unexpected or unobvious results of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to substitute the “H” group to a “methyl” such that one would arrive at the compounds of the instant invention.
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 1-4, 13, and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11339157 B1. Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the ‘157 patent are directed to compounds of the following genus and particular species thereof. Claims 6 and 7 are further directed toward compositions and combinations thereof.
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The genus substantially overlaps in scope with the instant invention, but differs in that R3 and R4 are both hydrogen.
While the exact compounds of formula I and claim 4 are not disclosed by Siegel et al., it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 126 U.S.P.Q. 477, 53 U.S. P.Q. 40 (C.C.P.A. 1942); In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963); In re Lohr, 317 F.2d 388, 137 U.S.P.Q. 548 (C.C.P.A. 1963); In re Hoehsema, 399 F.2d 269, 158 U.S.P.Q. 598 (C.C.P.A. 1968); In re Wood, 582 F.2d 638, 199 U.S. P.Q. 137 (C.C.P.A. 1978); In re Hoke, 560 F.2d 436, 195 U.S.P.Q. 148 (C.C.PA.A. 1977); Ex parte Fauque, 121 U.S.P.Q. 425 (P.O.B.A. 1954); Ex parte Henkel, 130 U.S.P.Q. 474, (P.O.B.A. 1960). Absent unexpected or unobvious results of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to substitute the “H” group to a “methyl” such that one would arrive at the compounds of the instant invention.
Claims 1-4, 13, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 13, and 15 of copending Application No. 17/605,975 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the ‘975 application are directed to compounds of the following genus, species thereof, compositions thereof, and combinations thereof.
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The genus substantially overlaps in scope with the instant invention, but differs in that R3 and R4 are both hydrogen.
While the exact compounds of formula I and claim 4 are not disclosed by Siegel et al., it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 126 U.S.P.Q. 477, 53 U.S. P.Q. 40 (C.C.P.A. 1942); In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963); In re Lohr, 317 F.2d 388, 137 U.S.P.Q. 548 (C.C.P.A. 1963); In re Hoehsema, 399 F.2d 269, 158 U.S.P.Q. 598 (C.C.P.A. 1968); In re Wood, 582 F.2d 638, 199 U.S. P.Q. 137 (C.C.P.A. 1978); In re Hoke, 560 F.2d 436, 195 U.S.P.Q. 148 (C.C.PA.A. 1977); Ex parte Fauque, 121 U.S.P.Q. 425 (P.O.B.A. 1954); Ex parte Henkel, 130 U.S.P.Q. 474, (P.O.B.A. 1960). Absent unexpected or unobvious results of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to substitute the “H” group to a “methyl” such that one would arrive at the compounds of the instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 13, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Application No. 17/605,990 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the ‘990 application are directed to a method of treating cancer, which necessarily discloses compounds of the following genus, species thereof, compositions thereof, and combinations thereof.
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The genus substantially overlaps in scope with the instant invention, but differs in that R3 and R4 are both hydrogen.
While the exact compounds of formula I and claim 4 are not disclosed by Siegel et al., it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 126 U.S.P.Q. 477, 53 U.S. P.Q. 40 (C.C.P.A. 1942); In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963); In re Lohr, 317 F.2d 388, 137 U.S.P.Q. 548 (C.C.P.A. 1963); In re Hoehsema, 399 F.2d 269, 158 U.S.P.Q. 598 (C.C.P.A. 1968); In re Wood, 582 F.2d 638, 199 U.S. P.Q. 137 (C.C.P.A. 1978); In re Hoke, 560 F.2d 436, 195 U.S.P.Q. 148 (C.C.PA.A. 1977); Ex parte Fauque, 121 U.S.P.Q. 425 (P.O.B.A. 1954); Ex parte Henkel, 130 U.S.P.Q. 474, (P.O.B.A. 1960). Absent unexpected or unobvious results of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to substitute the “H” group to a “methyl” such that one would arrive at the compounds of the instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 13, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 13, and 15 of copending Application No. 17/605,956 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the ‘956 application are directed to compounds of the following genus, species thereof, compositions thereof, and combinations thereof.
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The genus substantially overlaps in scope with the instant invention, but differs in that R3 and R4 are both hydrogen.
While the exact compounds of formula I and claim 4 are not disclosed by Siegel et al., it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 126 U.S.P.Q. 477, 53 U.S. P.Q. 40 (C.C.P.A. 1942); In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963); In re Lohr, 317 F.2d 388, 137 U.S.P.Q. 548 (C.C.P.A. 1963); In re Hoehsema, 399 F.2d 269, 158 U.S.P.Q. 598 (C.C.P.A. 1968); In re Wood, 582 F.2d 638, 199 U.S. P.Q. 137 (C.C.P.A. 1978); In re Hoke, 560 F.2d 436, 195 U.S.P.Q. 148 (C.C.PA.A. 1977); Ex parte Fauque, 121 U.S.P.Q. 425 (P.O.B.A. 1954); Ex parte Henkel, 130 U.S.P.Q. 474, (P.O.B.A. 1960). Absent unexpected or unobvious results of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to substitute the “H” group to a “methyl” such that one would arrive at the compounds of the instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 43-44 of copending Application No. 18/949,801 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the ‘801 application are drawn to species of compounds, including that below, and compositions thereof.
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The compound substantially overlaps in scope with the instant invention, but differs in that R3 and R4 are both hydrogen.
While the exact compounds of formula I and claim 4 are not disclosed by Siegel et al., it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 126 U.S.P.Q. 477, 53 U.S. P.Q. 40 (C.C.P.A. 1942); In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963); In re Lohr, 317 F.2d 388, 137 U.S.P.Q. 548 (C.C.P.A. 1963); In re Hoehsema, 399 F.2d 269, 158 U.S.P.Q. 598 (C.C.P.A. 1968); In re Wood, 582 F.2d 638, 199 U.S. P.Q. 137 (C.C.P.A. 1978); In re Hoke, 560 F.2d 436, 195 U.S.P.Q. 148 (C.C.PA.A. 1977); Ex parte Fauque, 121 U.S.P.Q. 425 (P.O.B.A. 1954); Ex parte Henkel, 130 U.S.P.Q. 474, (P.O.B.A. 1960). Absent unexpected or unobvious results of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to substitute the “H” group to a “methyl” such that one would arrive at the compounds of the instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 11/18/2025 have been fully considered but they are not persuasive.
35 U.S.C. 103 and Double Patenting
Regarding the rejection under 35 U.S.C. 103 over Siegel et al. (WO 2019/081486 A1), Applicant argues that Siegel et al. does not qualify as prior art under 35 U.S.C. 102(a)(1) because it was published less than one year from the earliest priority date of the instant application (Examiner clarifies that the earliest priority date is March 31, 2020 rather than May 31, 2020) and the Siegel et al. document includes several joint inventors also listed as joint inventors of the instant application (Remarks, p. 24-25). However, Applicant’s statement is insufficient to disqualify Siegel et al. as prior art. Per 35 U.S.C. 102(b)(1)(A), “a disclosure made 1 year or less before the effective filing date of a claimed invention shall not be prior art to the claimed invention under subsection (a)(1) if—(A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor” (emphasis added). Siegel et al. names other inventors (“another”) who are not listed as joint inventors of the instant application (e.g., Ulrich Klar, Eis Knut, Manh Phi Dinh, etc.). As the inventive entity of the two applications is not the same, it is unclear whether the subject matter cited by the Examiner was disclosed by or obtained from a common joint inventor. Moreover, in order to disqualify prior art under 35 U.S.C. 102(a)(1) by invoking the exception under 35 U.S.C. 102(b)(1)(A), Applicant must submit an affidavit or declaration under 35 U.S.C. 1.130 (see MPEP 717 and MPEP 2155.01).
Applicant additionally argues that substitution in the R3 or R5 position of the claimed genus results in an unexpected effect not taught by Siegel et al., “The claimed genus represents more than substitution of a hydrogen of a methyl… but instead illustrates that substitution at several positions maintains or increases compound efficacy. This result is unexpected” (Remarks, p. 25-26). This is not persuasive. A compound that is virtually equivalent in efficacy compared to the prior art is not considered unexpected, nor does Applicant provide any evidence to the matter. Per MPEP 716.02(a), greater than expected results or superiority of a property shared with the prior art may be used as evidence of nonobviousness. The data provided by the working examples of the instant specification do not establish that the claimed compounds are superior to the compounds of Siegel et al., as alleged by Applicant. For example, both the instant application and Siegel et al. perform the same assays in order to demonstrate the activity of their respective compounds. The instant specification (filed 11/18/2025) discloses the following compound (Example 85, p. 281).
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Example 85 differs from the following compound of Siegel et al. (Example 63, p. 254), as cited above, by a single methyl group in the R3 position.
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In the mutEGFR kinase assay on page 338 of the instant specification, Example 85 has an IC50 of 9.48 E-10, while in the same assay on page 300 of Siegel et al., Example 63 has an IC50 of 5.09 E-10 which is lower than that of the instant invention. Generally, no difference in efficacy can be seen when comparing the compounds of the instant invention to those of Siegel et al. (see Table 9 of Siegel et al.). The instant invention therefore fails to demonstrate unexpected results over the prior art.
Finally, Applicant argues that the Examiner has failed to provide a motivation to select any of the compounds of Siegel et al. as a lead compound to be modified (p. 26-27). This is not persuasive. In their argument, Applicant particularly refers to Takeda Chemical v. Alphapharm, 492 F.3d 1350, 1353 which allegedly establishes the requirement for selecting a lead compound. However, the facts of Takeda v. Alphapharm notably differ from that of the instant application. First, the prior art compound cited by Alphapharm differed from the compound of Takeda by two necessary modifications: substitution of a methyl group with an ethyl group, and moving the ethyl group to a different position on the ring. Second, the differences between the prior art and the Takeda patent included additional factors, wherein the prior art taught away from the compound cited by Alphapharm and the Takeda patent taught unexpected superior properties of the claimed compounds. The instant case, regarding Siegel et al. and the instantly claimed compounds, only differ by a single modification, wherein the compounds of Siegel et al. are equally effective compared to the claimed compounds and lack any disclosure that would dissuade one of ordinary skill from selecting the compounds of Siegel et al. As such, these important factors considered by the court in Takeda v. Alphapharm, which were considered in deciding whether the cited compound would be selected as a lead compound, are nowhere to be found in the instant case.
As previously stated, substitution of H vs. Me is not deemed patentably disctinct absent evidence of superior and/or unexpected properties. See additionally In re Wood 199 USPQ 137 and In re Lohr 137 USPQ 548 regarding addition of the methyl group to a known compound. Thus, one having ordinary skill in the art would have expected the structurally homologous compounds to possess similar properties.
The rejection is maintained. For the same reasons, the above nonstatutory double patenting rejections are also maintained.
35 U.S.C. 112(a)
In the Remarks filed 11/18/2025, Applicant argues that the specification adequately defines the term “chemotherapeutic anti-cancer agents” and additionally incorporates by reference other anti-hyperproliferative agents known in the art. This is not persuasive.
Examiner first notes that Applicant cites non-patent publications (Gilman’s The Pharmacological Basis of Therapeutics (Ninth Edition)) which incorporate by reference known anti-hyperproliferative agents. Per 37 CFR 1.57(d), “’Essential material’ may be incorporated by reference, but only by way of an incorporation by reference to a U.S. patent or U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference.” Non-patent publications cannot be used to incorporate essential material, such as claimed subject matter, by reference.
The applicants may only claim whatever he or she regards as his or her invention, i.e., the applicant may not claim subject matter that he or she does not regard as his or her invention. The use of “chemotherapeutic anti-cancer agent” does not set forth that which the applicants regard as their invention. The applicants are not entitled to preempt the efforts of others in future discoveries, wherein the claims are directed toward agents that have yet to be discovered. The applicants are only entitled to those additional active ingredients, i.e., anti-cancer agents, contemplated at the time of filing.
Where the utility is unusual or difficult to treat or speculative, such as in the case of treating cancer, the examiner has authority to require evidence that tests relied upon are reasonably predictive of in vivo efficacy by those skilled in the art. See In re Ruskin, 148 USPQ 221; Ex parte Jovanovics, 211 USPQ 907; MPEP 2164.05(a). Applicant has not demonstrated that the instant invention would be effective against cancer in combination with any and all anti-cancer agents. Moreover, combinations of pharmaceuticals can be antagonistic, even if they are known to have similar properties or indications.
Patent Protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. Tossing out the mere germ of an idea does not constitute enabling disclosure. Genentech Inc. v. Novo Nordisk 42 USPQ2d 1001.
As stated in the MPEP, 2164.08 "[t]he Federal Circuit has repeatedly held that the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). Nevertheless, not everything necessary to practice the invention need be disclosed. In fact, what is well known is best omitted. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991). All that is necessary is that one skilled in the art be able to practice the claimed invention, given the level of knowledge and skill in the art. Further the scope of enablement must only bear a reasonable correlation to the scope of the claims. See, e.g., In re Fisher, 427 F.2d 833, 839,166 USPQ 18, 24 (CCPA 1970). As concerns the breadth of a claim relevant to enablement, the only relevant concern should be whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims. In re Moore, 439 F.2d 1232, 1236, 169 USPQ 236, 239 (CCPA 1971). See also Plant Genetic Sys., N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1339, 65 USPQ2d 1452, 1455 (Fed. Cir. 2003) (alleged pioneer status of invention irrelevant to enablement determination).”
The rejection is maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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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/M.E.B./Examiner, Art Unit 1624 12/08/2025
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624