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 .
DETAILED ACTION
Status of the Claims
Claims 12-22 are pending. Claim 23 is withdrawn. Claims 12-19 and 21-22 are rejected. Claim 20 is objected to.
Election/Restrictions
Applicant's election of Group I drawn to a conjugate of formula I or TED compound of formula VI (now claims 12-22) and of the elected species compound 937 without traverse in the reply filed on 10/27/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 12-14, 18-20 and 22 read on Applicant’s species election of compound 937. Examination of the elected invention was conducted in accordance with the MPEP 803.02.
The elected species is free of the prior art; therefore, examination of the Markush-type claim has been extended to the scope of full scope of claims 12-22.
Claim 23 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Priority
This application is a 35 U.S.C. 371 National Stage Filing of International Application No. PCT/IB2021/052954, filed 04/09/2021, which claims priority under 35 U.S.C. 119(a-d) to. Acknowledgment is made of applicant's claim for foreign priority based on application CN202010276301.2, filed 04/09/2020. It is noted, however, that applicant has not filed an English translation of the certified copy of the CN202010276301.2 application as required by 37 CFR 1.55. Therefore, the effective filing date is 04/09/2021.
Information Disclosure Statement
The information disclosure statements (IDS) dated 10/11/2022, 09/04/2024 and 03/19/2025 have been considered.
Claim Objections
Claims 18 and 22 are objected to because of the following informalities:
Claim 18 is objected to for being written in improper Markush format. See MPEP 2173.05(h). In the paragraph beginning with “Ra” on page 23, the word “and” should be placed between the last two items of the list.
Claim 22 - “carriers” should be amended to “carrier”, unless Applicant intended multiple carriers in the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 18-22 are rejected under 35 U.S.C. 112(b) being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The last line of claim 18 refers to the “the linker group”, however the TED compounds of claim 12 do not have a clear definition of the intended “linker”. Many of the compounds of claim 12 have multiple NH and/or NH2 groups from which a hydrogen could be replaced by the W4-L3-W3- moiety of claim 18. Applicant may overcome the rejection by amending the claim to identify where the “linker group” of the TED compound.
Dependent claims 19-20 and 22-23 are rejected as indefinite for the same reason since they do not correct the indefiniteness issue of their parent claims.
Claim 19 uses the language "includes" which is an open-ended transition phrase. Per MPEP 2111.03 I, the use of such language "does not exclude additional, unrecited elements of method steps." Accordingly, the metes and bounds of the claims cannot be sufficiently interpreted by a person having ordinary skill in the art. Applicant may overcome the rejection by, for example, amending the claim to state “has” in place of “include”.
Regarding claim 21, the 1216 table entry includes the term “iRGD-C-M-PEG4-VC-PAB-961” of which “iRGD-C-M” is not defined in the specification and does not appear to be terminology a person having ordinary skill in the art would recognize. Applicant may overcome the rejection by deleting the term in the Table.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 12-18 and 21-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/699,857 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the pending claims.
Reference claim 6, for instance, discloses the conjugate
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(top left in the table) wherein R” is -W3-LT1-WP1-(RP)q1, per reference claim 1, which is identical to the structure of compound 961 in instant claims 12-13 and 15 before conjugation (i.e. when R” is H). Additionally, reference claim 6 discloses the conjugate
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(bottom right in the table) wherein R” is -W3-LT1-WP1-(RP)q1, per reference claim 1, which is identical to the structure of compound 1113,
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, in instant claims 12 and 16 before conjugation (i.e. when R” is H). Compound 937 of instant claim 14 is an obvious variant of the reference compound given its identical structure with only one stereocenter difference:
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(arrow added by Examiner). Instant claim 18 claims conjugates according to Formula (X):
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, wherein the definitions of Rp, W4, L3 and W3 are nearly identical to those of RP, W3, LT1 and WP1 of the reference claims. Thus, instant claims 12-18 are obvious.
Regarding instant claim 21, conjugate 1229,
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, is nearly identical in structure to the OLW-25 (a.k.a. UB-1811322) of reference claim 7. See Table D on page 208 of the reference specification:
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. The difference is in the number of PEG groups in the linker. Given that claim 4 of the reference application specifies a PEG linker,
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, wherein n5 is from 1-30, the claimed compound 1229 is obvious.
Regarding instant claim 22, drawn to a pharmaceutical composition comprising the conjugate, reference claim 10 is drawn to the same.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 12-22 are free of the prior art.
The closest appears to be WO 2016/105518, as cited in the IDS dated 03/19/2025 and CN 111018857, published 04/17/2020.
WO ‘518 discloses compounds dBET2, dBET7, dBET8, and dBET10 on pages 181, 183, 184 and 185, respectively. The prior art compounds are similar to some of the present claimed compounds instant claim 12. For instance, prior art compound dBET2,
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, differs from compound 937,
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, in that there is no cycloalkyl or alkyne group in the linker of the prior art compounds. Moreover, there is no motivation in the prior art to modify dBET2 or similar compounds in such a way to arrive at the presently claimed compounds or an obvious variant thereof.
CN ‘857 discloses the compound UB-180501:
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, see page 34 or page 42 of the English Machine Translation. The prior art compound is similar to compound 983,
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, of instant claim 12 except there is no triazole ring or other obvious substitution in the prior art. Moreover, there is no motivation in the prior art to modify UB-180501 in such a way to arrive at the presently claimed compounds or an obvious variant thereof.
Thus, the claims are free of the prior art.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jalisa H. Ferguson whose telephone number is (703)756-1489. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.H.F./Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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