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 amendment filed 1/6/2025 has been entered including the amendment to the specification.
Claims 16-26, 28-31, 33-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species. These claims, as amended, all require a NK-1 receptor-binding moiety having an SF5 group, while the elected species for the NK-1 receptor-binding moiety required a CF3 moiety. Thus, these claims are withdrawn as no longer reading on the elected species.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 32, 37 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Van Hagen et al. (from IDS; WO 92/18536; "Van Hagen") in view of Harrison et al. (from IDS; 1995 Bioorg. Med.Chem. Lett. 5: 209-212; "Harrison"), as applied to claims 16 - 19, 25 - 28, and 33 - 36 above, and further in view of Varasteh et al. (2013 Bioconjug. Chem. 17; 24: 1144-1153; "Varasteh"), for the reasons set forth in the office action mailed 3/14/2024.
Note new claims 37-38 encompass conjugates taught in the previous rejection having the same chelating agent, PEG linker and NK-1 receptor-binding moiety, and therefore are included herein for reasons of record.
Double Patenting
The text of the basis for nonstatutory double patenting not included in this action can be found in a prior Office action.
Claim 32, 37 and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,141,494 ("US'494") in view of Van Hagen et al. (from IDS; WO 92/18536; "Van Hagen"), for the reasons set forth in the office action mailed 3/14/2024.
Note new claims 37-38 encompass conjugates taught in the previous rejection having the same chelating agent, PEG linker and NK-1 receptor-binding moiety, and therefore are included herein for reasons of record.
Response to Arguments
Applicant's arguments filed 1/6/2025 have been fully considered but they are not persuasive.
With regard to the 103 rejection, Applicant asserts that Varasteh only teaches that a PEG linker provides favorable pharmacokinetic properties for the specific conjugates described therein and thus one of ordinary skill in the art would not be motivated to modify Van Hagen and Harrison by using a PEG linker.
This is not found persuasive. The 103 rejection set forth in the previous office action is based on the obviousness of combining three well known components (e.g., chelating agent-linker-NK receptor binding molecule) to arrive at conjugates as set forth in claim 32. Van Hagen teaches such conjugates but does not teach the specific PEG linker (which is taught by Varasteh) or specific NK-1 receptor binding molecule (which is taught by Harrison). The use of PEG linkers is well known in the art as shown by Varasteh. Contrary to applicant’s assertion, Varasteh does teach the use of PEG to modulate the pharmacokinetics of such conjugates, such that that PEG adds to the hydrophilicity to provide favorable pharmacokinetic properties of such conjugates, which would be expected to hold true for various conjugates due to the property of hydrophilicity of PEG. This is specifically what is taught by Varasteh. Obviousness does not require absolute predictability.
With regard to the obviousness type double patenting rejection, since applicant requests that the rejection be held in abeyance at this time, said rejection is maintained for reasons of record.
Conclusion
No claims are allowed at this time.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael G Hartley whose telephone number is (571)272-0616. The examiner can normally be reached 10-6:30.
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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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