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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1 – 7, and 9) drawn to a compound represented by formula (I) or a pharmaceutically acceptable salt thereof:
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wherein Y, L, A, X, R1-6, m, n, and p are defined and the species election of
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in the reply filed on October 15th, 2025 is acknowledged.
Claims 8 and 10 – 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II (a preparation method) and Group III (a method of inhibiting PD-1/PD-L1), there being no allowable generic or linking claim. Moreover, claim 3 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species wherein instant R8 is not an alkyl group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 15th, 2025.
Claims 1 – 11 are currently pending in the application. However, due to a restriction requirement, claims 3, 8, and 10 – 11 are withdrawn from further consideration and claims 1 –2, 4 – 7, and 9 are being examined on the merits herein. Nevertheless, upon initial search the elected species of structure
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was found to befree of the prior art. Thus the search has been expanded to include all chemical species; hence, all chemical species as recited in instant claim 1 have been rejoined. Therefore, the election of species requirement set forth in the office action mailed September 19th, 2025 has been withdrawn; but the restriction requirement between groups is still maintained.
Hence claims 1 – 7, and 9 are examined on the merits herein.
Drawings
The drawings are objected to because the drawings contains a trademark name. More Specifically, Figures 1A and 1B contain the word, “Keytruda,” which is the trade name for pembrolizumab. The use of the term Keytruda, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 2 and 7 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.
Claim Rejections - 35 USC § 112
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 pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 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.
Claim 3 recites, the compound or pharmaceutically acceptable salt thereof according to claim 1, wherein R1 and R2 each are independently represents OH,
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which implies that the carbons wherein R9-11 are attached are attached through instant R7. However, in claim 1, R1 and R1 each independently represent NR7R8, OR8 or a substituted C4-C6 azacycloalkyl wherein R7 represents H or C1-C3 alkyl. Thus according to instant claim 1 R7 can only be a H or a C1-C3 alkyl group that is unsubstituted. Therefore, given this interpretation instant claim 3 fails to further limit instant claim 1. 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.
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.
Claims 1, 4 – 6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018305315 A1 to Aktoudianakis et. al. (herein after Aktoudianakis’315; cited on IDS).
Regarding claims 1, 4 – 6, and 9, Aktoudianakis’315 teach species compound example 69 of structure
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(instant claim 1) (page 194 paragraph 1742) wherein instant R3 and R4 are CH3 (instant claim 4); instant Y is O; instant L is -CH2O- ; instant A is phenyl; instant m is 1; instant R1 and R2 are NR7R8 wherein R7 is H and R8 is propyl substituted with OH, that is
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(instant claim 5); instant R5 is Cl (instant claims 4 – 5), instant R6 is 5-cyanopyridin-3-yl (instant claims 4 – 5). Additionally, Aktoudianakis’315 teach compounds of the disclosure as inhibitors of PD-1/PD-L1, or the PD-1/PD-L1 interaction (page 1 paragraph 0002) and as therapeutic for methods of treating cancer (page 76 paragraph 1099). Moreover, Aktoudianakis’315 teach compounds of the disclosure include pharmaceutical salt of the compounds of the disclosure which encompasses inorganic acids salts that further include hydrochloric acid and hydrobromic acid (instant claim 6) (page 12 paragraph 0177). Furthermore, Aktoudianakis’315 teach compounds of the disclosure may be administered in a pharmtuically formulation comprising carriers (instant claim 9) such as sesame oil, corn oil, or peanut oil for injectable emulsions (page 78 paragraph 1111).
However, Aktoudianakis’315 fail to teach a compound wherein instant X is O and instant n = 1 (instant claim 1).
[AltContent: oval]Nevertheless, the only difference between compounds of the instant application and prior art compound example 69 of structure
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is the connectivity of the circled area. Wherein instant claim 1 requires the diphenyl to be bonded to the O followed by a -CH2- unit, prior art compound teach compound example 69 wherein the diphenyl system is connected to the -CH2- unit followed by the O; thus, the only difference is a structural difference. Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977)(MPEP 2144.09(II)).
Conclusion
Claims 1, 3 – 6, and 9 are rejected. Claims 2, and 7 are objected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627