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
Priority
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, is acknowledged.
Status of Claims
Claims 1-3, 5, 6, 9-11, 18-20, 24, 26, 33, 34, 46, 47, and 50 are currently pending in the application.
Receipt is acknowledged of amendment / response filed on July 22, 2026 and that has been entered.
Information Disclosure Statement
Receipt is acknowledged of Information Disclosure Statement (IDS), filed on 01/17/2024, which has been entered in the file.
Response to Election/Restriction
In response to the restriction requirement Applicants have elected Group I, which includes claims 1-3, 5, 6, 24, 26, 33, 34, 46, and 47 drawn to a Ligand Drug Conjugate composition represented by Formula 1 and the elected species as set forth a Ligand Drug Conjugate, such as,
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with traverse, is acknowledged. Applicant’s arguments (to withdraw the restriction requirements) have been fully considered and found partially persuasive and therefore, Examiner agreed to modify the restriction requirements to include and examine Groups II and III claims 9-11 and 18-20 together with the elected invention of Group I, because they commensurate within the scope of the elected invention.
However, Applicant’s other arguments have been fully considered and found unpersuasive at this time because the Invention groups I-IV differ materially in structure and in element from each other and therefore, are capable of supporting their own patents. The invention groups I-IV are related to a set of structurally diverse compounds / compositions and their method of uses (chemical structures, which are similar, are presumed to function similarly, whereas chemical structures that are not similar are not presumed to function similarly), which do not possess a substantial common core wherein a reference anticipating one would not necessarily render the other obvious and to search all the above Groups in a single application would be an undue burden on the Examiner. Because of several classes and subclasses in each of the Group, a separate search considerations are involved, which would impose a serious burden on the Examiner to perform a complete search of the defined areas if unrestricted. Also, the fields of search are not coextensive. The wide disparity among the groups requires that many divergent fields must be searched, including all classes and subclasses of U.S. and foreign patents as well as journals and publications. Moreover, the Examiner must perform a commercial database search on the subject matter of each group in addition to a paper search, which is quite burdensome to the Examiner. Nevertheless, Examiner may reconsider to rejoin non-elected inventions commensurate in scope with the product claims when the case would be found in condition for allowance [provided those claims are free from 35 U.S.C. §112 first (including written description, reach-through claim language and/or scope-enablement issues) and second paragraphs]. For these reasons, Applicant’s arguments are found unpersuasive and, therefore, the requirement for restriction and election of species is still deemed proper and made it final.
Claim 50 is withdrawn from further consideration pursuant to 37 C.F.R. 1.142 (b) as being drawn to a non-elected subject matter.
Applicants preserve their right to file a divisional on the non-elected subject matter.
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. See 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-3, 5, 6, 9-11, 18-20, 24, 26, 33, 34, 46, and 47 are rejected under the judicially created doctrine of obviousness-type double patenting, as being unpatentable over claims 1, 2, 4, 7, 13-15 and 20 of co-pending application No. 18/940,208 (US ‘208). This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the same art recognized subject matter. A reference anticipating one set of claim will render the other obvious and it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, since US ‘208 co-pending application teaches the generic conjugate compounds, compositions and their method of uses which are similar to the instantly claimed inventions. The subject matter claimed in the instant application is fully recited and covered in the claims of US ‘208 co-pending application. Therefore, the disclosure of US ‘208 co-pending application that teaches many permutation and combinations, which would easily place Applicant’s invention in possession of the public before the effective filing date of the claimed invention. The indiscriminate selection of “some'' among “many'' is prima facie obvious, In re Lemin, 141 USPQ 814 (1964). Therefore, in the instant case, one skilled in the chemical art would be motivated to choose to replace variable substitutions in permutation and combinations in core structure to obtain the desired compound of formula I, in view of the known teaching of the art, such as,
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(claim 1 of US ‘208 co-pending application). The claimed compounds and their compositions are so closely related structurally to the homologous and /or analogous compounds of the reference as to be structurally and methodically obvious, therefore in the absence of any un-obviousness or unexpected properties. Moreover, any other differences are but obvious structural and/or methodically modifications, which would be apparent to one skilled in the chemical art that can use similar substitutions, would expect to have the same or essentially the same results and therefore, is obvious, absent evidence to the contrary.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Golam Shameem, Ph.D. whose telephone number is (571) 272-0706. The examiner can normally be reached on Monday-Thursday from 7:30 AM - 6:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks, Ph.D. can be reached at (571) 270-7682.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://portal.uspto.gov/external/portal. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist, whose telephone number is (571) 272-1600.
/GOLAM M SHAMEEM/Primary Examiner, Art Unit 1621
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