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 .
Receipt is acknowledged of IDS filed on 05/06/2024 and 06/13/2025.
Claims 1, 18, 22, 24, 43-45, 47, 50-54, 57-58, 60, 63-64, 71 and 74 are pending.
Claims 2-17, 19-21, 23, 25-42, 46, 48, 49, 55, 56, 59, 61, 62, 65-70, 72, 73, and 75-104 are cancelled.
Claims 24, 43-45, 47, 50-54, 57-58, 60 and 63-64 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I and Species A in the reply filed on 07/31/2026 is acknowledged.
The requirement is deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112b
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.
Claim 1, 18, 22, 71 and 74 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 contains the term "KRAS", which is not defined by the claims. Claims must stand
alone to define the invention, and should not rely on the description or the drawings to give them
meaning (see Ex Parte Fressola, 27 USPQ 2d 1608). Thus, claim 1, at the very least, should define "
KRAS” by its formal name; once " KRAS " is defined, the term " KRAS " may be subsequently
Recited.
The claims are drawn to an almost unlimited number of variations due to the large number of different chemical substitutions set forth in the claims, such as, wherein Formula III, which has variables Q1, L1, L2, E, X, n, R2, R5, R7, R6, R12, L3, R14, R15, R15’, and m, etc. In certain circumstances, however, a Markush group may be so expansive that persons skilled in the art cannot determine the metes and bounds of the claimed invention. For example, if a claim defines a chemical compound using one or more Markush groups, and that claim encompasses a massive number of distinct alternative members, the claim may be indefinite under 35 U.S.C. 112(b) if one skilled in the art cannot determine its metes and bounds due to an inability to envision all of the compounds defined by the Markush group(s). In such a circumstance, a rejection of the claim for indefiniteness under 35 U.S.C. 112(b) is appropriate.
The dependent claims fall therewith.
Improper Markush Rejection
Claims 1, 18 71, and 74 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of the components of the formulation is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
The claims are directed to a radiopharmaceutical conjugate comprising a targeting ligand and a radionuclide.
The composition involves Formula III, which has variables Q1, L1, L2, E, X, n, R2, R5, R7, R6, R12, L3, R14, R15, R15’, and m, which according to Applicant’s claims,
ring Q1 is a 4-12 membered saturated or partially saturated monocyclic or bicyclic ring, wherein
the monocyclic or bicyclic ring is optionally substituted;
L1 is a bond, -C(=O)-, or optionally substituted C1-C3 alkylene;
L2 is a bond, -C(=O)-, O, S or NR15;
E is
PNG
media_image1.png
111
161
media_image1.png
Greyscale
X is C(=O), P(=O)OR2, C(=S), or S(=O)n, where n is 1 or 2;
R2 is hydrogen or optionally substituted C1-C3 alkyl;
R5 is hydrogen, cyano, halogen, C1-C6 alkyl, C1-C6 alkoxyl, C1-C6 heteroalkyl, C3-C6 cycloalkyl, or C2-C5 heterocycloalkyl, wherein each of the alkyl, alkoxyl, heteroalkyl, cycloalkyl or heterocycloalkyl is optionally substituted, and
R7 is hydrogen, cyano, halogen, C1-C6 alkyl, C1-C6 alkoxyl, C1-C6 heteroalkyl, C3-C1 cycloalkyl, C2-C1 heterocycloalkyl, or heteroaryl, wherein each of the alkyl, alkoxyl, heteroalkyl, cycloalkyl, heterocycloalkyl, or heteroaryl is optionally substituted; or
R5 and R7 taken together form a bond; or R5 and R7 taken together with the carbon atoms to which they are attached form a 5-8 membered partially saturated cycloalkyl, wherein the cycloalkyl is optionally substituted;
R6 is hydrogen, cyano, halogen, C1-C6 alkyl, C1-C6 alkoxyl, C1-C6 heteroalkyl, C3-C6 cycloalkyl, C2-C6 heterocycloalkyl, or heteroaryl, wherein each of the alkyl, alkoxyl, heteroalkyl, cycloalkyl, heterocycloalkyl, or heteroaryl is optionally substituted;
R12 is hydrogen, C1-C6 alkyl, C1-C6 heteroalkyl, -L3-NR15R15', heterocycloalkyl, -L3 heterocycloalkyl, cycloalkyl, -L3-cycloalkyl, aryl, heteroaryl, -L3-aryl, or -L3-heteroaryl, wherein each of the heterocycloalkyl, cycloalkyl, aryl, heteroaryl, alkyl or heteroalkyl is optionally substituted;
L3 is C1-C4 alkylene or C1-C4 heteroalkylene, each of which is optionally substituted;
each R13 is independently OH, halogen, oxo, substituted or unsubstituted C1-C6 alkyl, or substituted or unsubstituted C 1-C6 heteroalkyl;
R14 is hydrogen, cycloalkyl, heterocycloalkyl, aryl, or heteroaryl, wherein each of the cycloalkyl, heterocycloalkyl, aryl, and heteroaryl is optionally substituted;
each R15 is independently hydrogen or C1-C3 alkyl;
each R15' is independently hydrogen, acyl, C1-C3 alkyl, C1-C3 heteroalkyl or C1-C3 hydroxyalkyl;
M is 0, 1, or 2,
wherein the structure of Formula (III) is attached to the rest of the conjugate at any suitable
position;
It is duly noted that the above options for the variables can contain any variety of structures due to the variability, which can encompass various different chemical classes, such as proteins, antibodies, etc., which all have different structural features and utilities.
Applicants’ attention is directed to the third paragraph of MPEP 803.02 which discloses:
“Since the decisions in In re Weber, 580 F.2d 455, 198 USPQ 328 (CCPA 1978) and In re Haas, 580 F.2d 461, 198 USPQ 334 (CCPA 1978), it is improper for the Office to refuse to examine that which Applicants regard as their invention, unless the subject matter in a claim lacks unity of invention. In re Harnisch, 631 F.2d 716, 206 USPQ 300 (CCPA 1980); and Ex parte Hozumi, 3 USPQ2d 1059 (Bd. Pat. App. & Int. 1984). Broadly, unity of invention exists where compounds included within a Markush group (1) share a common utility, and (2) share a substantial structural feature essential to that utility.”
In response to this rejection, Applicant should either amend the claim(s) to recite only an individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1) (emphasis provided).
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 18, 22, 71 and 74 are rejected under 35 U.S.C. 103 as being unpatentable over CHRISTENSEN (WO 2020/118066) in view of SENTISSI (US 10,183,975 B2).
Regarding claims 1, 18, and 22, CHRISTENSEN teaches the following compound for treating KRas G12C cancers (abstract):
PNG
media_image2.png
148
134
media_image2.png
Greyscale
(page 177), which matches Applicant’s structure:
PNG
media_image3.png
170
166
media_image3.png
Greyscale
(instant claim 22) with the exception of using Bromide instead of the radionuclide Iodine-131. The compound is further used to treat non-small cell lung cancer (claim 81).
CHRISTENSEN does not teach adding the radionuclide Iodine-131.
SENTISSI teaches a compound to treat non-small cell lung cancer (claim 27) that utilizes Iodine-131 (I-131). I-131 can be used as an anticancer drug (column 2, paragraph 6). Specifically I-131 localizes at a tumor site and results in cell destruction (column 32, paragraph 5). Additionally I-131 can be used for imaging purposes for cancer (column 36, paragraph 1-2). I-131 in summary can be used as both a radiolabel, for imaging and a cytotoxic therapeutic agent, for the treatment/destruction of cancer (column 37, paragraph 3).
Regarding claim 71, CHRISTENSEN teaches the compound can include a pharmaceutically acceptable carrier, excipient or dilutant (page 83, paragraph 0127).
Regarding claim 74, CHRISTENSEN teaches the compound is administered to treat KRas G12C cancers (abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate the radionuclide Iodine-131. The person of ordinary skill in the art would have been motivated to make those modifications, because it can be used as both a therapeutic agent to treat cancer and as a radiolabel for imaging, and reasonably would have expected success because the references are in the same field of endeavor, such as compounds for the treatment of cancer, such as non-small cell lung cancer.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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, MICHAEL HARTLEY can be reached at (571) 272-0616. 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.
/S.L.M./ Examiner, Art Unit 1618
/Michael G. Hartley/ Supervisory Patent Examiner, Art Unit 1618
Prosecution Insights