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 . Claims 1-11 and 13-15 are pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group I and a single disclosed species (compound P6) in the reply filed on 07/15/2026 is acknowledged.
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The examiner searched the elected species and found no prior art; thus, the search was expanded to cover full scope of the elected invention of Group I.
Claim Rejections - 35 USC § 112
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 1-11 are 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:
a. Claim 1 and claims dependent thereon are rejected because the phrase “A1 is selected such that A1-OH is a therapeutic, diagnostic or theranostic agent which contains an -OH group that is attached to a 5- or 6-membered aromatic or heteroaromatic ring” is not clear. What is the exact definition of A1? What does it mean “a therapeutic, diagnostic or theranostic agent which contains an -OH group”? Is the -OH attached to A1 (A1-OH) the same as the -OH in the therapeutic, diagnostic or theranostic agent? Is the definition of A1 a 5- or 6-membered aromatic or heteroaromatic ring contain an -OH? Note that the definition A1 is not straight forward and it is confusing. It is recommended that applicants review the definition of A1 and amend the claim so that the definition of A1 is clear. For example, A1 = alkyl, halogen, 5- or 6-membered aromatic or heteroaromatic ring, etc.
b. Claim 1 is rejected because the phrase “A2-NH-A3 are independently selected such that A2-NH-A3 is a therapeutic, diagnostic or theranostic agent which contains an -NH2 or -NH- moiety” is not clear. Is A2-NH-A3 the same as -NA2A3? How is A2-NH-A3 attached to ring A? Is the -NH2 or -NH- moiety attached to -NA2A3 shown below?
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Note that the definition of A2 and A3 is not straight forward and it is confusing. It is recommended that applicants review the definition of A2 and A3 and amend the claim so that the definition of A2 and A3 is clear. For example, A2 and A3 are independently H, alkyl, halo, etc.
c. Claim 1 and claims dependent thereon are rejected because the phrase “L is….a self-immolative spacer” is indefinite. What is covered and what is not? How can one tell if a given spacer is not covered by the claim?
d. Regarding claim 4, the term "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the term are part of the claimed invention. See MPEP § 2173.05(d).
Information Disclosure Statement
5. Applicant’s Information Disclosure Statement, filed on 12/19/2023 has been acknowledged. Please refer to Applicant’s copies of the 1449 submitted herewith.
Conclusion
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kahsay Habte Ph.D. whose telephone number is (571)272-0667. The examiner can normally be reached on 8:30 - 5:00 PM.
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 on 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 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 https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Kahsay Habte/
Primary Examiner, Art Unit 1624
July 29, 2026
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