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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Current Status of 18/572,447
This Office Action is responsive to the election received 9 February 2026.
Claims 1-3, 5, 7-8, 10-12, 14-16, 18-19, 21-22, 24, and 26 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Group I, being claims 1-3, 5, 7-8, 10-12, and 14-16 in the reply filed on 9 February 2026 is acknowledged.
Applicant has also elected the following species:
A species of formula (II) of Fig. 37, shown below:
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A species of “cargo”, being dinaciclib.
The elected species of formula (II) does not appear to read on any of the claims within Group I. This is because the definition of R8, within claim 1, does not allow for the group present within the structure above. The Examiner will herein examine claims 1, 5, 7-8, 10, and 14-16.
Claims 2-3, 11-12, 18-19, 21-22, 24, and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
Applicant’s claim for the benefit of the prior-filed patent applications PCT/US2022/034302 (filed 21 June 2022) and 63/213,053 (filed 21 June 2021) under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) received on 4 June 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, this information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
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, 5, 7-8, 10, and 16 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 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 inventors, at the time the application was filed, had possession of the claimed invention.
Factors to be considered in making the determination as to whether one skilled in the art would recognize that the applicant was in possession of the claimed invention as a whole at the time of filing include: (a) Actual reduction to practice; (b) Disclosure of drawings or structural chemical formulas; (c) Sufficient relevant identifying characteristics such as: (i) Complete structure, (ii) Partial structure, (iii) Physical and/or chemical properties, or (iv) Functional characteristics when coupled with a known or disclosed correlation between function and structure; (d) Method of making the claimed invention; (e) Level of skill and knowledge in the art; and (f) Predictability in the art. While all of these factors are considered, a sufficient number for a prima facie case are discussed below.
Claims 1 and 8 recite the phrase “and combinations thereof” when referring to alternate chemical moieties (claim 1 recites this phrase in multiple locations). For example, the definition of R4 recites C1-C6 alkyl, C3-C8 cycloalkyl, halogen, and so on, concluding with “and combinations thereof”. This quoted phrase allows these R groups (such as R4) to include an infinite number of possible moieties using infinite possible combinations. If Applicant is claiming an infinite number of compounds, this is strong evidence that they did not have possession of the claimed invention. Infinitely complex moieties would indicate that the portion of the total structure explicitly shown by Applicant is exceedingly small, which in turn provides little information about the claimed compounds to one of ordinary skill in the art. Due to the unpredictability in the chemical arts, particularly when attempting to elicit a biological response, one of ordinary skill in the art would not know from the instant disclosure which of the infinite compounds would be useful as anti-tumor agents. Applicant may choose to remove all occurrences of the “and combinations thereof” language within claims 1 and 8. This lack of written description is inherited by claims 5, 7, 10, and 16, meaning that claims 1, 5, 7-8, 10, and 16 lack written description.
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 14-15 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 14 shows R8 and R9 as moieties that are in different locations as compared to R8 and R9 in the parent claim, claim 1. R9 is close to R6 in claim 1, but R9 is close to R7 in claim 14. The definition of R8 within claim 14 does not fall within the definition of R8 in claim 1. For claim 14 to be a proper dependent claim, depending upon claim 1, the W-A-CH2-X group of claim 14 would need to fall within the definition of R8 in claim 1, but it doesn’t. Perhaps Applicant intended the CH2-X portion, connected to Y, to be a part of the linker, but currently this cannot be the case, because Y is explicitly defined as the linker in claim 14. Claim 15 does not remedy the problems arising from claim 14.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5, 7-8, 10, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
SIMBERG (WO 2019/126565 A1, International Publication Date 27 June 2019).
Claim 1 of SIMBERG teaches a lipophilic membrane dye that is covalently linked to a cargo moiety. SIMBERG teaches the specific lipophilic membrane dye shown below, referred to as DIR-SS-daunorubicin and compound 9, on pages 59 and 62 therein.
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Compound 9 of SIMBERG can be shown to fall within the scope of a compound of formula (II), of instant claim 1, by defining the variables of the compound of formula (II) as follows: q and r are each equal to 0, R6 and R7 are each C18 straight-chain alkyl groups, R8 is a C1 alkyl group, there is a linker covalently attached to the indocarbocyanine group, and there is a small-molecule chromophore covalently attached at the left side of the structure above.
Claim 28 of SIMBERG teaches the administration of the compounds therein through oral administration. Example 9 of SIMBERG teaches that the compounds therein can be used to act as biosensors within the tumor microenvironment (Pg. 49, Ln. 5-21). SIMBERG specifically teaches the use of a breast cancer tumor mouse model for in vivo testing of the compounds therein (Pg. 52, Ln. 5-9).
Regarding claim 10: Claim 10 narrows the definition of the chemotherapeutic agent of claim 8 or the antibody of claim 8, but claim 10 does not require the presence of either of these cargo moieties. Therefore, because SIMBERG teaches an embodiment of claim 8 that does not violate the requirements of claim 10, claim 10 is also anticipated.
Conclusion
No claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN D MCANANY whose telephone number is (571)270-0850. The examiner can normally be reached 8:30 AM - 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANDREW D 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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/JDMc/Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625