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 .
See interview summary filed 04/17/2026.
This is second Non-Final Rejection.
Amended claims 1-7, 10-12, 15, 17-22, 24-26, 36, 37, 43-45, 52, 56,58 are pending.
Previously presented rejections are withdrawn.
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 1-7, 10-12, 15, 17-22, 24-26, 36, 37, 43-45, 52, and 56-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of US12168060. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims encompass the compounds of the instant claims in genus-species relationship
wherein the formula
PNG
media_image1.png
24
56
media_image1.png
Greyscale
of claim 1 of US12168060 is the genus that includes the instant formula I species.
J targeting moiety of instant formula is antibody (as per example instant claims 43) of the above formula
PNG
media_image1.png
24
56
media_image1.png
Greyscale
.
The G part of above formula is defined in claims 10 and 11 of US12168060 provide more visualizable structural moieties in recited formula I and overlap in anticipatory fashion.
The instant Q part defined as active moiety (as clarified and defined in instant dependent claims 20-22) is defined in claim 16 of US12168060, in anticipatory fashion.
For definition of terms such as the targeting moiety and active moiety in the instant claims and active agent in conflicting claims, in addition to the dependent claims, disclosure in the conflicting cases are consulted. See Note below.
The pertinenet art made of record and not relied upon is considered pertinent to applicant's disclosure.
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.
Note that Reliance on specification of a potentially conflicting patent or application is generally prohibited. However limited exceptions do exist. Exceptions to the General Prohibition of Using the Disclosure of a Potentially Conflicting Patent or Application include Dictionary for claim terminology, Portions of the disclosure which provide support for the claims in the potentially conflicting patent or application.
The MPEP refers to two exceptions to the general prohibition of using the disclosure of a potentially conflicting patent or application in an ODP-Obviousness analysis. The two exceptions are:
1. The disclosure can be used as a dictionary for claim terminology; and
2. “[T]hose portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent” (MPEP § 804).
The MPEP further notes:
The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first “determine how much of the patent disclosure pertains to the invention claimed in the patent” because only “[t]his portion of the specification supports the patent claims and may be considered.” The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103 since only the disclosure of the invention claimed in the patent may be examined.”)
Likewise (Likewise for the same reasons discussed above)
Claims 1-7, 10-12, 15, 17-22, 24-26, 36, 37, 43-45, 52, and 56-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of
US11807628. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter.
US11807628 Claim 1 formulae contains the critical structural elements of the instantly claimed formula in a genus-species relationship.
For example, see claim 1 as found in Certificate of correction page 2 of 2 .
Further evidence that meta disubstituted aryl and pyridyl compounds are part of the claim 1 of the conflicting claims is found in the compounds disclosed at column 163-172 and at column 177-178.
The compounds disclosed here contains all the structural moieties,
meta substituted phenylene, 3,5 substituted pyridine, targeting moiety J and active moiety Q of the instant claim 1 formula.
Likewise (Likewise for the same reasons discussed above)
Claims 1-7, 10-12, 15, 17-22, 24-26, 36, 37, 43-45, 52, and 56-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of US12274898 . Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims encompass the compounds of the instant claims in genus-species relationship. For example buried in the definition of the formula of US12274898, at column 248, the Z moiety corresponds to the meta-disubstituted aryl and pyridyl formula of the instant formula I.
Likewise (Likewise for the same reasons discussed above)
Claims 1-7, 10-12, 15, 17-22, 24-26, 36, 37, 43-45, 52, and 56-58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 27 of copending Application No. 18827143 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other in genus-species relationship, wherein the instant claim is the genus and the claim of 18827143 species claim.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The pertinenet art made of record and not relied upon is considered pertinent to applicant's disclosure.
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.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
11945827
2274898
11807628
RN 2395004-75-6 HCAPLUS
CN 3-Pyridinecarboxamide, N-(17-azido-3,6,9,12,15-pentaoxaheptadec-1-yl)-5-[3-[(4-methylphenyl)sulfonyl]-1-oxopropyl]- (CA INDEX NAME)
PNG
media_image2.png
164
1025
media_image2.png
Greyscale
Claim 1, 2, 4, 12, 17-19, 22,
M =N
R46 is aryl
L is linker as in claim 19 (which depends on claim 12), as in claim 17 and 18 (which depend on claim 12 ‘comprises alkylene, CH2-CH2 in peg
Q is azide (as in claim 22)
12168060 17358306
Prosecution Insights