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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/16/2026 has been entered.
Response to Amendment
The amendments received 07/16/2026 have been entered. Claims 1-17 and 19-28 are pending. Any objection or rejection set forth in the Office Action mailed 03/16/2026 has been overcome and is withdrawn.
Information Disclosure Statement
The Information Disclosure Statement filed on 04/06/2026 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of list of references cited from the IDS is included with this Office Action.
Claim Objections
Claims 1, 4, and 10 are objected to because of the following informalities:
Claims 1, 4, 10: "Aryl" should read "aryl".
Claim 1, 4: an extra comma is present before the structure of p-aminobenzyloxycarbonyl.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 and 19-28 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 sets forth definitions for Z and Z’ wherein “R55 is independently selected from…”. However, there are no moieties listed that contain R55. The scope of the claims is therefore unclear. The claims which depend from claim 1 do not clarify the limitation at issue and are also rejected.
Claim 1 and 6 recites “or combination above thereof”. It is unclear to which alternatives “above” refers. The claims which depend from claims 1 and 6 do not clarify the limitation at issue and are also rejected.
Claim 1, 4, 6 sets forth multiple definitions for R3 and R3’, p and p’. The claims which depend from claims 1, 4, and 6 do not clarify the limitation at issue and are also rejected.
Claims 6-7, 11-12, 19-20 are replete with instances of a listed alternative being set forth along with a second definition in parenthesis. In some instances, the definitions in the parenthesis seem to set forth shortened term by which the alternative listed before the parenthesis is known (such as “toluenesulfonyl (tosyl)” in claim 6). In other instances, the definitions in the parenthesis are broader or narrower in scope than the alternative listed before the parenthesis. It is unclear, in every instance of a second definition being set forth in parenthesis, whether each alternative is limited to what is set forth in the parenthesis, especially when the scope is either narrower or broader. Clarification is required.
Claim 6 recites “-S-cell-binding agent”. The term “cell-binding agent” does not convey a particular structure known in the art and could read on thousands of possible moieties.
Claim 9 depicts “Ph1” and “Ph2” but does not define either variable. Given that they are numbered, it is unclear whether Ph is supposed to mean “phenyl” as is typically understood in the art.
Claim 10 recites “independently comprise:”. A Markush list of alternatives must be closed (“consisting of” or “selected from the group consisting of” or “is”). It is unclear what other alternative limitations are encompassed by the claim.
Claims 11 and 19 have been amended such that “analog” and “derivative” have been replaced with “compound” or “compounds”. The specification, on page 18, defines “compound” to “include compounds for which a structure or formula or any derivative thereof has been disclosed in the present invention or a structure or formula or any derivative thereof that has been incorporated by reference. The term also includes, stereoisomers, geometric isomers, tautomers, solvates, metabolites, salts (e.g., pharmaceutically acceptable salts) and prodrugs, and prodrug salts of a compound of all the formulae disclosed in the present invention. The term also includes any solvates, hydrates, and polymorphs of any of the foregoing”. The definition for the term “compound” is an open definition and, besides explicitly including derivatives, solvates, metabolites, prodrugs, etc., would be reasonably interpreted to include other forms such as analogs. These terms are indefinite because they do not have a defined structure known in the art. One could not ascertain as to which analogs and derivatives are within the scope of the claim, nor would one be apprised to the degree of which a compound may differ from its parent structure (e.g., folate) to be considered a “derivative”, “analog”, prodrug, etc., resulting in millions of combinations. One could not possibly envisage all the possibilities of a “compound” of the instant invention.
Claim 19 recites “including” and “comprising” in multiple instances. A Markush grouping should be a closed list of alternatives. These terms are indefinite because it is unclear what other alternatives are included.
Claim 24 recites “wherein L1 and L2 independently comprise”. A Markush group should be a closed list of alternatives. These term “comprising” is indefinite because it is unclear what other alternatives are included.
Claim 26 recites “wherein r, r1, r2, and r’ are independently 0-200”, however, the structures depicted in claim 26 do not contain r1 or r2.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7, 9, 10, 11, 21, 22, 23, and 27 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 7 sets forth the structure for formula (V-05) and (VI-03) which is not within the scope of claim 6 because it contains a triple bond between L1 and L2. See also dependent claim 9 which sets forth the structures 277, C-20, and C-21.
Claim 10 recites “of Formula (I), (Ia), (Ib), (Ic), (Ie): (III), (II), (III), or (IV)”. Claim 10 depends on claim 1 wherein formulas (Ia), (Ib), (Ic), (Ie), (III), (II), or (IV) are not recited.
Claim 11 sets forth alternatives for the cell binding molecule of claim 1. Claim 1 recites:
PNG
media_image1.png
154
590
media_image1.png
Greyscale
However, the alternatives set forth in claim 11 are not all within the scope of the above limitations. For example, somatostatin is not an antibody or an antibody fragment, nor are analogs of vitamin B12. Correction is required.
Claim 21 recites “U and U’ are… C(O)NH”. Claim 1, from which claim 21 depends, does not include C(O)NH in the definition of U and U’.
Claims 22 and 23 set forth alternatives for E1 and E2 that are not within the scope of claim 1:
PNG
media_image2.png
74
392
media_image2.png
Greyscale
PNG
media_image3.png
78
208
media_image3.png
Greyscale
and
PNG
media_image4.png
160
630
media_image4.png
Greyscale
, respectively. These alternatives lack antecedent basis.
Claim 27 recites alternatives for L1-E1-Q-E2-L2 that are not within the scope of claim 1 because they lack a cross-linker such that one of L1-E1 or E2-L2 are absent. Per claim 1, L1 and L2 cannot be absent as at least a single bond must be shared between them.
PNG
media_image5.png
198
595
media_image5.png
Greyscale
The aforementioned claims therefore fail to incorporate all the limitations of the claims from which they depend and are of improper dependent form.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-17 and 19-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 4, and 6 have been amended to recite formulas (A), (B), and/or (C). However, no such formulae have been disclosed, either implicitly or explicitly, in the disclosure at the time of filing. Formulas (A), (B), and/or (C) are considered new matter and do not comply with the written description requirement.
Claims 22 and 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 22 and 23 set forth alternatives for E1 and E2:
PNG
media_image2.png
74
392
media_image2.png
Greyscale
and
PNG
media_image4.png
160
630
media_image4.png
Greyscale
, respectively. These moieties were not disclosed as alternatives for E1 and E2 at the time of filing, and can only be found within definitions for L1 and L2, but there is no suggestion that the same structures were considered to be within the scope of E1 and E2. These limitations therefore constitute as new matter. Correction is required.
Response to Arguments
Applicant's arguments filed 07/16/2026 have been fully considered but they are not persuasive.
Regarding the rejection of claims 22 and 23 under 35 U.S.C. 112(a) for introducing new matter, Applicant argues that the moieties recited in claims 22 and 23 are described in paragraphs [0123] and [0175] of the published application. However, paragraph [0123] does not depict any of the moieties recited in either claim 22 or 23. Moreover, this deficiency is not remedied by paragraph [0175]. Applicant argues that paragraph [0175] refers to “the linker” of which E1 and E2 are parts. However, neither the structure of Formula (I) nor the examples of E1 and E2 establish that E1 and E2 are part of “the linker”. It is unclear what “linker” Applicant argues that E1 and E2 are part of. The only variables clearly described as being part of a “linker” are L1 and L2, which are separate from E1 and E2 in the structure of Formula (I). The rejection is maintained.
The remaining rejections that are maintained above were not addressed or argued against by Applicant, nor did Applicant’s amendments to the claims overcome the rejections. While Applicant’s response is considered bona-fide, the rejections are maintained.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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, Jeffrey Murray can be reached at (571) 272-9023. 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.
/MADELINE E BRAUN/Examiner, Art Unit 1624 08/03/2026
Prosecution Insights