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 .
Applicant’s election without traverse of Group II (Claims 26-29 and 40) in the reply filed on April 29, 2026 is acknowledged. Claims 1-4 and 20, 62, 64, 66, 73-77, 79 and 80 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 29, 2026.
For election of species, applicant elected Formula (IIE-1) (wherein L1 is –(C=O)N(RN)- and L2 is -O-CH2CH2-). Since there was no prior art found which anticipates or renders obvious the elected formula, the search was expanded to other formulas shown in claim 27.
As to applicant’s request for rejoinder of claims 1-4, 20, 62, 64, 66, 73-77 and 79-80 if the elected Group II claims are found to be allowable, it is to be noted that even if the elected Group II claims (claims 26-29 and 40) were found to be allowable, the non-elected claims 1-4, 20, 62, 64, 66, 73-77, 79 and 80 will not be rejoined since these non-elected claims are directed to different inventions (Groups I and II do not share the same or corresponding technical feature and Groups II and III do not share the same or corresponding technical feature) that were restricted out and do not depend on claim 26.
It is to be noted that the effective filing date of instant claims 26-29 and 40 is November 24, 2021, not March 1, 2021 (filing date of the provisional application 63/154,883) or November 24, 2020 (filing date of the provisional application 63/117,539) were filed since those provisional applications do not support the subject matter of instant claims 26-29 and 40.
Claim Objections
Claim 26 is objected to because of the following informalities: throughout the claim, applicant keep using the expression “ . . . is selected from A, B, C and D”. Applicant need to change such expression either to --- . . . is selected from A, B, C or D --- or to --- . . . is selected from the group consisting of A, B, C and D ---. For example, on the 2nd line following the chemical formula (II), applicant recite “X is selected from C(R3)2, NR3, O, S, and . . .”. Applicant need to change “and” to --- or ---. Alternatively, applicant can change instead “X is selected from” to --- X is selected from the group consisting of ---. Appropriate correction is required throughout the claim.
Claim 27 is objected to because of the following informalities: right before the last chemical formula shown in the claim, applicant need to change “Formula (IIE-14); and” to --- Formula (IIE-14); or ---. Alternatively, applicant can change instead “is selected from:” on line 1 to --- is selected from the group consisting of: ---. Appropriate correction is required.
Claim 28 is objected to because of the following informalities: right before the last chemical formula shown in the claim, applicant need to change “Formula (II-10); and” to --- Formula (II-10); or ---. Alternatively, applicant can change instead “is selected from:” on line 1 to --- is selected from the group consisting of: ---. Appropriate correction is required.
Claim 29 is objected to because of the following informalities: (i) on lines 1-2, applicant need to delete “the compound is a compound of Formula (II);” (as such phrase is redundant – claim 26 is drawn only to the compound of Formula (II)). (ii) on line 3, applicant need to change “H and C6-10 aryl;” to --- H or C6-10 aryl; ---. Appropriate correction is required.
Claim 40 is objected to because of the following informalities: (i) on lines 1-2, applicant need to delete “the compound is a compound of Formula (II) and” (as such phrase is redundant – claim 26 is drawn only to the compound of Formula (II)). (ii) on line 3, applicant need to change “and” to --- or ---. Appropriate correction is required.
Claim 26 is objected to because of the following informalities: (i) on the 4th line following the chemical formula (II), applicant need to change “C1-100 alkenyl, and” to --- C2-100 alkenyl, or ---; and change “R1” to --- R1B ---. (ii) applicant need to delete “and” as in “targeting ligand; each R3 is independently selected from H, C1-15 alkyl, C2-15 alkenyl, and C2-15 alkynyl, . . . “. (iii) on the 15th line from the bottom of the claim, applicant need to insert --- or --- between “5- to 10-membered heteroaryl,” and “4- to 10-membered heterocycloalkyl”. (iv) on the 14th line from the bottom of the claim, applicant need to delete “and” in front of “C2-15 alkynyl,”. (v) on the 13th line from the bottom of the claim, applicant need to change “and” (in front of “-N(RN)2;”) to --- or ---. (vi) on the 11th line from the bottom of the claim, applicant need to change “and” (in front of “C2-15 alkynyl forming”) to --- or ---. (vii) on the 7th line from the bottom of the claim, applicant need to change “and” (in front of “C2-15 alkynyl forming Ro”) to --- or ---. Appropriate correction is required.
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 26-29 and 40 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.
(i) In the middle of claim 26, applicant recite “each R3 is independently selected from H, C1-15 alkyl, C2-15 alkenyl, C2-15 alkynyl, C3-10 cycloalkyl, C6-10 aryl, 5- to 10-membered heteroaryl, and 4- to 10-membered heterocycloalkyl optionally substituted with one or more R10;”. It is unclear from the claim language whether the limitation “optionally substituted with one or more R10” applies to all of the R3 groups (except for the H atom) or only to the 4- to 10-membered heterocycloalkyl group.
For the purpose of examining the claim on the merit, the Examiner assumed (based on the reading of present specification (see pg.51, lines 14-31, pg.52, lines 1-5 present specification) that applicant meant the limitation “optionally substituted with one or more R10” to apply to all of the R3 groups (except for the H atom).
Instant 112(b) rejection can be overcome by changing “each R3 is independently selected from H, C1-15 alkyl, C2-15 alkenyl, C2-15 alkynyl, C3-10 cycloalkyl, C6-10 aryl, 5- to 10-membered heteroaryl, and 4- to 10-membered heterocycloalkyl optionally substituted with one or more R10;” to --- each R3 is independently selected from H, C1-15 alkyl, C2-15 alkenyl, C2-15 alkynyl, C3-10 cycloalkyl, C6-10 aryl, 5- to 10-membered heteroaryl, or 4- to 10-membered heterocycloalkyl, wherein the C1-15 alkyl, C2-15 alkenyl, C2-15 alkynyl, C3-10 cycloalkyl, C6-10 aryl, 5- to 10-membered heteroaryl, or 4- to 10-membered heterocycloalkyl is optionally substituted with one or more R10; ---.
(ii) on the 19th and 20th lines from the bottom of claim 26, applicant recite “each R11 is independently selected from C1-15 alkyl, C2-15 alkenyl, and C2-15 alkynyl optionally substituted with one or more R12;”. It is unclear from the claim language whether the limitation “optionally substituted with one or more R12” applies to all of the R11 groups listed above or only to the C2-15 alkynyl group.
For the purpose of examining the claim on the merit, the Examiner assumed that applicant meant the limitation “optionally substituted with one or more R12” to apply to all of the R11 groups listed in the claim.
Instant 112(b) rejection can be overcome by changing “each R11 is independently selected from C1-15 alkyl, C2-15 alkenyl, and C2-15 alkynyl optionally substituted with one or more R12;” to --- each R11 is independently selected from C1-15 alkyl, C2-15 alkenyl, or C2-15 alkynyl, wherein the C1-15 alkyl, C2-15 alkenyl or C2-15 alkynyl is optionally substituted with one or more R12; ---.
Claims 26-29 and 40 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.
In Claim 26, applicant recite that “each R4, R5, R6 and R7 is independently selected from . . . , or an R5 and an R6, together with the atoms to which they are attached, come together to form C6-10 aryl or 5- to 10-membered heteroaryl, wherein . . .”. (i) It is not clear to the Examiner whether or not the R5 and R6 that appear after “or” are the same as the R5 and R6 that are defined before “or”. That is, does the definition for the R5 and R6 that appear before “or” also apply for the R5 and R6 that appear after “or”? (ii) Also, what do applicant mean by “the atoms”? Are they referring to the atoms that appear in the definition (which appear before “or”), or are they referring to some other atoms? Appropriate clarification and/or correction is required.
Claim 27 is 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.
There is no definition for the variable “a2” in Formula (IIC) and Formula (IID) shown in claim 27, thus rendering the scope of the claim indefinite.
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.
Claim 27 is 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.
In Claim 27, Formula (IIE-2), Formula (IIE-3), Formula (IIE-4), Formula (IIE-5), Formula (IIE-6), Formula (IIE-12), Formula (IIE-13), Formula (IIE-14) and Formula (IIE-15) fail to further limit the general formula (II) shown in claim 26. That is, claim 26 does not indicate that Ring C and Ring D can directly be connected to each other (through a single bond) as shown in Formulas (IIE-4) and (IIE-5) (also, there seems to be no support for such scenario in the originally filed disclosure). Also, claim 26 does not indicate that Ring C and Ring D can be connected through two X moieties as shown in Formulas (IIE-2), (IIE-3), (IIE-12), (IIE-13), (IIE-14) and (IIE-15) (one X being NR3 and the other X being S, O or NR3) (also, there seems to be no support for such scenario in the originally filed disclosure). Claim 26 does not indicate that R3 (as in NR3) and Ring D can be connected to each other (through a -N(H) moiety) as shown in Formula (IIE-6) (also, there seems to be no support for such scenario in the originally filed disclosure). Thus, claim 27 fails to further limit the subject matter of instant claim 26.
In Claim 28, by the same logic, Formulas (II-3), (II-4), (II-5), (II-6) and (II-7) fail to further limit the general formula (II) shown in claim 26. Thus, claim 28 fails to further limit the subject matter of instant claim 26.
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 § 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)(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.
Claim(s) 26, 27 and 40 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by HEINRICH et al (US 2025/0032625 A1).
Heinrich teaches Compound 46 (see pg.134) which chemical structure is shown below:
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348
665
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Such compound teaches instant Formula (IIA) of instant claim 27 (and thus teaches instant Formula (II) of claim 26 as well): instant R1B is -CH3 (C1 alkyl), m = 1, both Ring C and Ring D are C6 aryl, x = 0, y = 0, R3 (as in -N-R3) is C6 aryl substituted with CF3 (instant R10 which is C1 haloalkyl), n = 0, L1 = -(C=O)N(RN)- (with RN being H atom), p = 2, L2 = -O-CH2CH2-, q = 4, R2 is a chemical moiety shown below;
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115
172
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which molecular weight is 272. Thus, the chemical moiety shown here teaches instant targeting ligand of claim 40, which is a small molecule (i.e., having molecular weight of less than 500 Daltons – see pg.80, line 10 of present specification).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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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 .
/SIN J LEE/
Primary Examiner, Art Unit 1613
June 20, 2026
Prosecution Insights