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
Claims 28,51-52,55,58,74,78,80-81 and 91-94 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/2/2025. Upon reconsideration the examiner withdraws the species election in the office action filed 4/30/2025, as the claims in their current state do not present an undue burden to search the polymer species together.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2,7,10,12-13,23 and 26 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Gao (US 9,751,970).
Gao discloses pH sensitive micelles containing the following block copolymers:
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336
312
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Greyscale
Including the more specific example below:
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200
276
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, note the 2nd structure contains PEO and DBA (reading on R1 and R2 are C1-C6 alkyl) and L is a fluorescent quencher and/or NIR label. See entire disclosure, especially abstract, Fig. 8, claims 1 and 11-14. R’’’ includes halogens, see claim 12. The integer for PEG in the example above is 114, within the range of n1 in claim 1 and 13 and x includes the data point 200, within the range of x1 in claim 1 and 7. Regarding claims 10 and 12, in the formula above y can be 0, which reads on formula I claimed in which y1 and z1 are 0. See col 4 lines 44-45. Regarding claims 23 and 26, these claims recite additional features of an optional component in independent claim 1 (therapeutic agent) and are not further limiting. Note the repeat unit z1 that includes Y can be 0 and therefore not present.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2,7,10,12-13,23 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9,751,970. Although the claims at issue are not identical, they are not patentably distinct from each other because the 9,751,970 patent overlaps with the claimed polymer formulas of the pending claims. The main difference is the presence of the optional therapeutic agent containing block of the pending claims, which is not claimed in the patent. However, since the block containing the therapeutic agent is optional the claims overlap and are not patentable distinct.
Claims 1-2,7,10,12-13,23 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,017,598. Although the claims at issue are not identical, they are not patentably distinct from each other because the 10,017,598 patent overlaps with the claimed polymer formulas of the pending claims. The main difference is the presence of the optional therapeutic agent containing block of the pending claims, which is not claimed in the patent. However, since the block containing the therapeutic agent is optional the claims overlap and are not patentable distinct.
Claims 1-2,7,10,12-13,23 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,098,150. Although the claims at issue are not identical, they are not patentably distinct from each other because the 11,098,150 patent overlaps with the claimed polymer formulas of the pending claims. The main difference is the presence of the optional therapeutic agent containing block of the pending claims, which is not claimed in the patent. However, since the block containing the therapeutic agent is optional the claims overlap and are not patentable distinct.
Claims 1-2,7,10,12-13,23 and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 17/614,638 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘638 application overlaps with the claimed polymer formulas of the pending claims. The main difference is the presence of the optional therapeutic agent containing block of the pending claims, which is not claimed in ‘638. However, since the block containing the therapeutic agent is optional the claims overlap and are not patentable distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2,7,10,12-13,23 and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 119 of copending Application No. 17/198,006 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘006 application overlaps with the claimed polymer formulas of the pending claims. The main difference is the presence of the optional therapeutic agent containing block of the pending claims, which is not claimed in ‘638. However, since the block containing the therapeutic agent is optional the claims overlap and are not patentable distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
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/JAMES W ROGERS/Primary Examiner, Art Unit 1618