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 .
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.
Claim(s) 43-52 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11484597 further in view of the teachings Niu US 20110230476 and Yang, US 9724352.
.Although the claims at issue are not identical, they are not patentably distinct from each other, in a genus (instant)-species (‘597) relationship.
The entirety of the teachings of Niu and Yang is reproduced, is reproduced here, in the obviousness analysis:
Niu teaches irreversible inhibitors. multiple examples. of PI3 Kinases and conjugates.
Exemplified compounds of Niu are shown in page 36, Column B to page 39 column A.
Comparison of the structural make-up of the above shown conjugates of Niu and those of the exemplified compounds (see dependent claims 35, 36, 38 reveals that the only difference is in that the instantly claimed compounds have a different the core structure of P13 Kinase inhibitor, that is being conjugated (for covalent modification).
Therefore the deficiency of Niu is the bicyclic heterocyclic core, the P13 Kinase inhibitor of the core formula of base claim 20.
The deficiency of the Niu is cured by the teachings of Yang, because Yang teaches the instant P13 kinase inhibitors, multiple examples at columns 7-29 containing the instantly pictured bicyclic heterocyclic moiety. The examples of Yang demonstrates that the P13 kinase inhibiting property can be optimized by modification of the substituents decorating the invariable structural moiety of the bicyclic heterocyclic group.
With the combined teachings of Niu and Yang one of skill in the art would arrive at the instant claim limitations by
1.applying the idea of covalent modification of P13K inhibitors of Niu with Michael Acceptors
2. Replacing the heterocyclic core P13K inhibitor of Niu with that of the inhibitor of Yang
to make alternate P13K inhibitor conjugates
as per instant claims and those in the claims of 11484597.
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Substitution of the known structural element of Yang to make modified Niu compounds is unobvious. The multiple examples noted above with respect to Niu and Yang exemplification correspond to the instant R and L and X variables which are the limitations of dependent claims in anticipatory manner.
For example claim 22 line 2 second structure X (MA) is the same as the one in above pictured Niu compound.
R3 as in claim 27 is the same as the one in above pictured Yang compound.
R4 as in claim 31 is the same as the one in above pictured Yang compound.
Genus-Species:
CLM in ‘597 claim 1 formula is the same as in instant claim 22 and so on.
Instant elected species See Remarks filed 09/05/2025 numbered page 18 is the compound at claim column 139 3rd compound!.
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988) and In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992).
Note: the duplicative, redundant, re-entering of Niu and Yang teachings is as per Examination guidelines (so as to make the rejection independent and complete in itself to OSA!).
The following does not include the above awkward re-entering of Niu and Yang teachings.
Likewise (Likewise means for the same rationale)
claim(s) s 43-52 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-46 of copending Application No. 17642945 further in view of the teachings Niu US 20110230476 and Yang, US 9724352. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims contain overlapping subject matter.
Instant elected species and species of claim 43 of 17642945 are, respectively:
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and
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These claims are isosteric modification NH for O of each other and also compare pictured Yang compound and 17642945 claim 46 compound.
Also note the file wrapper of 17642945 has approved terminal disclaimer for claims of US 11484597.
Likewise (Likewise means for the same rationale)
claim(s) s 20-37 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17, 22, 39 of copending Application No. 18849949 further in view of the teachings Niu US 20110230476 and Yang, US 9724352. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims contain overlapping subject matter.
Rejections - 35 USC § 103 is invoked here in the obviousness analysis.
Instant elected species and species of claim 5 of 18849949 are, respectively:
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and
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These claims are isosteric modification NH for O of each other and represent anticipation as seen in instant claim 31!, and pictured Yang compound.
This is a provisional nonstatutory double patenting rejection.
Likewise (Likewise means for the same rationale)
claim(s) s 43-52 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 38, 40, 41 of copending Application No. 18550878 further in view of the teachings Niu US 20110230476 and Yang, US 9724352. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims contain overlapping subject matter.
The entirety of Niu and Yang teachings discussed under section Claim Rejections - 35 USC § 103 is invoked here in the obviousness analysis.
Instant elected species
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Claim 38;
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Dependent claim 41
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This is a provisional nonstatutory double patenting rejection.
The prior art made of record and not relied upon is considered pertinent here:
Feldman, Understanding ‘Evergreening’ : Making Minor Modifications Of Existing
Medications To Extend Protections, Health Affairs June 2022 41:6, 801-804
Dwivedi, Evergreening: A deceptive device in patent rights, Technology in Society 32
(2010) 324–330.
Copending Applications
A search in USPTO data base for conjugates of returns 51 hits. As such Applicant is encouraged to check for additional copending applications and issued patents for overlapping subject matter in the claims and file terminal disclaimers.
MPEP 2001.06(b) Information Relating to or From Copending United States Patent Applications [R-08.2012]: The individuals covered by 37 CFR 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are “material to patentability” of the application in question. As set forth by the court in Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972):
[W]e think that it is unfair to the busy examiner, no matter how diligent and well informed he may be, to assume that he retains details of every pending file in his mind when he is reviewing a particular application . . . [T]he applicant has the burden of presenting the examiner with a complete and accurate record to support the allowance of letters patent.
THIS ACTION IS MADE FINAL. 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 NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
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