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 .
Status of claims
Pending claims 3-20 have been examined on the merits.
Withdrawn rejections
The rejection of claim 3 under 35 U.S.C. 112(b) is withdrawn due the claim amendment.
The rejection of claims 3-20 under 35 U.S.C. 103 as being unpatentable over Berkman et al. (WO 2018098390) in view of DiMagno (US 20180066298) and Babich et al. (WO 2018187631), is withdrawn due to Applicant’s argument.
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.
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 3-20 are rejected under 35 U.S.C. 103 as being unpatentable over Berkman et al. (WO 2018/098390) in view of Babich et al. (WO 2018187631), Ali et al., J. Chem. Soc. Pak., Vol. 36, No. 1, 2014, 150-169, Patani et al., Chem. Rev. 1996 Dec 19;96(8):3147-3176.
Regarding claim 3-10, Berkman (page 50, claim 18) teaches a compound of formula (Ij) that meets each and every chemical structure variable of the claimed invention; wherein each R1 to R8 are hydrogen; R is a detectable label or therapeutic drug; n is 3; m is 2; p is 1; L1 and L2 are each independently a covalent bond or a divalent linking group.
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Berkman (page 50, claim 18) teaches Z linker with an extra ethyl group and also a similar linker in compound of Formula (Ii), without the ethyl group, showing that alkyl length is a variable. Thus, a person of ordinary skill in the art (POSITA) would consider selecting different alkyl lengths as routine optimization in drug development and arrive at the claimed invention.
Berkman does not explicitly teach thioamide linkage.
Ali (page 155) teaches O and S are classical bioisosteres, indicating they are interchangeable. Therefore, a POSITA would have been motivated to substitute sulfur for an
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oxygen with reasonable expectation that such modification could improve the compound’s pharmacological properties. This is supported by Patani (page 3155, section B) which teaches divalent bioisosteres which involve the interchange of atoms that are involved in a double bond, such as in the series; C=C, C=N, C=O, and C=S. Patani (page 3155, section B) also teaches replacement of the sulfur atom with oxygen or selenium , another well-known divalent isosteric replacement, resulted in weaker activity relative to the thio analogue. (See MPEP 2143(B)).
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Regarding claim 11-12, Berkman (page 51), and as applied to claim 3-10 above, teaches a compound comprises the L2 structural variable as claimed.
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Regarding claim 13-14, Berkman (page 51), and as applied to claim 3-10 above, teaches a compound comprises the L2 structural variable as claimed.
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Regarding claim 15, Berkman (page 51), and as applied to claim 2-10 above, teaches a compound comprises the L2 structural variable as claimed.
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Regarding claim 16-20, Babich (page 113, RSP077), and as applied to claim 3-10 above, teaches a compound wherein n= 3, m and p = 1; all of the Rs are hydrogen, L1 linker attaches to a chelating agent, and L2 linker. Although Babich’s compound RSP077 comprises four acetic acids instead of three, however, Babich (page 88) discloses compound 617, which has three acetic acids and compound 068 has four acetic acids on the chelating agent. Therefore, a POSITA would have recognized that the number of acetic acids is a variable feature and that a chelating agent containing either three or four acetic acids were contemplated as alternative options.
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Response to Arguments
Applicant argues the 103 rejection is not proper because DiMagno reference was published less than one year before the effective filing date of the claimed invention. Applicant also provided an Affidavit confirm that the publication is Applicant’s own work. Applicant’s argument is persuasive; thus the 103 rejection is withdrawn.
Applicant also argues that that neither Berkman and Babich teach a thioamide linkage and, therefore the 103 rejection is not valid. Applicant’s argument is not percussive. The newly recited prior art in the 103 rejection above teach that O and S, and C=S and C=O, are bioisosteres. Thus, providing motivation to POSITA to reasonably exchange C=O with C=S, and arrive at the claimed thioamide linkage. (See MPEP 2143(B)).
Conclusion
Therefore, claims 3-20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JAMES H ALSTRUM-ACEVEDO can be reached on (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
