DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the cited rejections 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.
3. Response to Election/Restriction filed on 5/5/2026 is acknowledged.
4. Claim filed on 5/5/2026 is acknowledged.
5. Claims 3, 5, 6, 9, 11, 12, 14-16, 18-22, 24, 26-31, 33, 34, 37, 39-43, 45-47, 49-51, 53, 55, 59 and 60 have been cancelled.
6. Claims 1, 2, 4, 7, 8, 10, 13, 17, 23, 25, 32, 35, 36, 38, 44, 48, 52, 54 and 56-58 are pending in this application.
7. Claim 58 is withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim.
8. Claims 1, 2, 4, 7, 8, 10, 13, 17, 23, 25, 32, 35, 36, 38, 44, 48, 52, 54, 56 and 57 are under examination.
Elections/Restrictions
9. Applicant’s election without traverse of Group 1 (claims 1, 2, 4, 7, 8, 10, 13, 17, 23, 25, 32, 35, 36, 38, 44, 48, 52, 54, 56 and 57) and election without traverse of Example 57 with the structure
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as species of compound of Formula I or a pharmaceutically acceptable salt thereof in the reply filed on 5/5/2026 is acknowledged. The requirement is made FINAL in this office action.
Group 1 is drawn to a compound of Formula I
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, or a pharmaceutically acceptable salt thereof; and a pharmaceutical composition comprising such compound and a pharmaceutically acceptable excipient. A search was conducted on the elected species; and this appears to be free of prior art. A search was extended to the genus in claim 1; and prior art was found. Claims 1, 2, 4, 7, 8, 10, 13, 17, 23, 25, 32, 35, 36, 38, 44, 48, 52, 54, 56 and 57 are examined on the merits in this office action.
Objections
10. The specification is objected to for the following minor informality: The specification recites the chemical structure/formula of Acd0574 on page 102, and the chemical structure/formula of KTFE on page 113 of instant specification. The quality of these chemical structures/formulae is poor. Applicant is required to provide clear image of these chemical structures/formulae.
Please note: The specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification (see MPEP § 608.01).
11. Claim 1 is objected to for the following minor informality: Applicant is suggested to amend claim 1 as “A compound of Formula I
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, wherein: R3 is…and the number of ring atoms in ring A is 15 to 17…”.
12. Claims 2, 4, 25, 38, 48 and 54 are objected to for the following minor informality: Applicant is suggested to amend these claims as “The compound or the pharmaceutically acceptable salt thereof of claim 1…”.
Furthermore, claim 38 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
13. Claims 7, 8 10, 13, 17, 23, 32, 35, 36, 44 and 52 are objected to for the following minor informality: Applicant is suggested to amend these claims as “The compound or the pharmaceutically acceptable salt thereof of claim 1, wherein:…”.
Furthermore, claims 32 and 35 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In addition, Applicant is suggested to add a semicolon after the recited “X9 is
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” in instant claim 52.
14. Claim 56 is objected to for the following minor informality: Applicant is suggested to amend claim 56 as ““The compound of claim 1, wherein the compound is selected from the group consisting of…”.
Furthermore, Applicant is required to incorporate the chemical structure of Examples 1-693 into claim 56.
Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
15. The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
16. Claim 56 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
17. Claim 56 recites “The compound of claim 1 having the structure of any one of Examples 1-693”. With regards to Examples 1-693, the instant specification fails to disclose the structure of Example 681 or 682. Therefore, the metes and bounds of instant claim 56 is vague and indefinite.
Claim Rejections - 35 U.S.C. § 112 paragraph (d)
18. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
19. Claim 52 is rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA ), 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
20. Claim 52 depends on claim 1; and claim 52 recites “X9 is
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”. However, X9 recited in instant claim 1 is C1-3 alkylene substituted with R9b and R9c…R9b and R9c are each independently H, C1-6 alkyl, C1-6 haloalkyl, C1-6 alkyl-OH, C2-6 alkoxyalkyl, C3-6 cycloalkyl, C1-4 alkyl-C3-6 cycloalkyl, heteroaryl, or C1-4 alkyl-heteroaryl, wherein each heteroaryl has 5 to 6 ring members and from 1 to 3 heteroatoms each independently N, O, or S, and each cycloalkyl and heteroaryl is independently substituted with 0 to 3 R9c1; alternatively, R9b and R9c together with the carbon to which each is attached combine to form a C3-4 cycloalkyl substituted with 0 to 2 R9c2…each R9c1 and R9c2 is independently C1-4 alkyl, -OH, C1-4 alkoxy, halo, C1-4 haloalkyl, or C1-4 haloalkoxy”. Therefore, the scope of X9 recited in instant claim 52 is broader than the scope of X9 recited in claim 1. Claim 52 does not further limit the structure of the compound or the pharmaceutically acceptable salt thereof of claim 1; thus, claim 52 is improper dependent forms for failing to further limit the subject matter of claim 1.
Furthermore, for the purpose of this examination, the Examiner is interpreting X9 in claim 52 as the recited structure without
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and
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.
Claim Rejections - 35 U.S.C. § 103
21. 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 of this title, 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.
22. 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 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.
23. Claims 1, 2, 4, 7, 8, 10, 13, 17, 23, 25, 36, 44, 48, 54 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Bair et al (US 2004/0077549 A1, filed with IDS).
The instant claims 1, 2, 4, 7, 8, 10, 13, 17, 23, 25, 36, 44, 48, 54 and 57 are drawn to a compound of Formula I
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, or a pharmaceutically acceptable salt thereof; and a pharmaceutical composition comprising such compound and a pharmaceutically acceptable excipient.
Bair et al, throughout the patent, teach compounds that inhibit the interaction of the transcription factor E2F-1 to Cyclin A; and a pharmaceutical composition comprising such compound and a pharmaceutically acceptable excipient, for example, Abstract; and page 8, paragraph [0185]. It meets the limitation of “a pharmaceutically acceptable excipient” recited in instant claim 57. One of such compounds in Bair et al is Cpr-Lys-(CH(CH3)(C13H27))-Lys-(Lys-Leu-Phe-Gly), for example, pages 10-11, Example 1. The compound Cpr-Lys-(CH(CH3)(C13H27))-Lys-(Lys-Leu-Phe-Gly) in Bair et al reads on R3 being
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, R4a, R4b and R5a being H, R5b and R5c being H and
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, R6a and R6b being H, X6 being
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, R6d and R9a being H, X9 being CH2, R8a, R8b, R8d and R8e being H, B being phenyl, m8 being 0, R7a being H, R7b and R7c being H or
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, and the number of ring atoms in ring A being 16 in the compound recited in instant claims 1, 2, 4, 7, 8, 10, 13, 17, 23, 25, 36, 44, 48, 54 and 57, except the limitations of R4c, wherein the compound in Bair et al does not teach R4C1 and R4C2 in instant claimed compound. Bair et al further teach Lys in such compound can be one substituted by C1-C17 alkyl, including a compound with the structure
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, for example, page 2, paragraphs [0042] and [0047]; and pages 11-12, paragraph [0215]. It meets the limitations of the compound recited in instant claims 1, 2, 4, 7, 8, 10, 13, 17, 23, 25, 36, 44, 48, 54 and 57 except the R4c of instant claimed compound.
The difference between the reference and instant claims 1, 2, 4, 7, 8, 10, 13, 17, 23, 25, 36, 44, 48, 54 and 57 is that the reference does not have an example that teaches the R4c of instant claimed compound.
However, the only difference between the compounds, in particular the compound with the structure
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taught in Bair et al above and instant claimed compound is the length of alkyl group used to modify the Lys residue (the R4c of instant claimed compound). And since they differ only by a methylene group in such a large molecule, they are considered homologs and expect to possess similar properties. The MEPE states: “A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. “An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties…” (see MPEP § 2144.09 I); and “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties…” (see MPEP § 2144.09 II). And in the instant case, as taught in Bair et al, C1-C17 alkyl shares similar utilities.
Therefore, it would have been obvious to one of ordinary skilled in the art to modify the compounds, in particular the compound with the structure
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taught in Bair et al above and develop a compound recited in instant claims 1, 2, 4, 7, 8, 10, 13, 17, 23, 25, 36, 44, 48, 54 and 57; and a pharmaceutical composition comprising such compound and a pharmaceutically acceptable excipient.
Please note: The structural difference in the instant application and prior art is precisely by deleting one –CH2- unit in both alkyl chains linking to the ε-amino group of the Lys in
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part of the compound with the structure
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taught in Bair et al. One of ordinary skilled in the art would have had a reasonable expectation of success given that Bair et al explicilty teach C1-C17 alkyl shares similar utilities.
Thus, the invention as a whole is prima facie obvious over the reference, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI N KOMATSU whose telephone number is (571)270-3534. The examiner can normally be reached Mon-Fri 8am-4pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached on 5712707430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658
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