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 .
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 3/27/2026 wherein the specification and claims 11, 14-16, 18, and 19 were amended.
Note(s): Claims 1-33 are pending.
Priority and Priority Document
This application is a 371 of PCT/EP2021/078181 filed 10/12/2021 which claims benefit to PCT/EP2020/078571 filed 10/12/2020.
Note(s): The earliest effective filing date is 10/12/2020 as the pending application is fully supported in PCT/EP2020/078571.
The Examiner acknowledges receipt of the prior document, PCT/EP2020/078571, filed 4/11/2023.
Claim Interpretation
Independent claim 1 is directed to a compound of Formula (1) V-(Y-P)n wherein V is a peptide comprising a vector; P is a group comprising one or more payloads P1; Y is a reactive moiety that is covalently attached to the side chain of an amino acid in V; and n is an integer from 1 to 3.
Claim 23 is directed to a kit comprising the compound of claim 1 and a buffer.
Claim 25 is directed to a method of regioselective modification of an antibody or fragment thereof wherein the antibody fragment is optionally incorporated into a Fc-fusion protein, the method comprising reacting an antibody or fragment thereof with a compound of claim 1.
Claim 27 is directed to a modified antibody or modified antibody fragment obtainable by reacting an antibody of antibody fragment, the antibody fragment is optionally incorporated into a Fc-fusion protein along with a compound of claim 1.
Claim 30 is directed to a method of diagnosing, monitoring, imaging or treating a disease as set forth therein.
Applicant’s Election
Applicant's election without traverse of Group I (pending claims 1-24) filed 3/27/2026 is acknowledged. The restriction requirement is still deemed proper and is therefore made FINAL.
Applicant elected the species,
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, wherein the following claims read on the species: (1) Formula (1) of claim 1; (2) Formula (2a) of claim 2; (3) P1 is a moiety (i) derived form a labeling moiety; (4) P1 is a chelating agent (1, 4, 7-triazacyclononane-1,4,7-triacetic acid (NOTA) optionally conjugated to a radionuclide; (5) claim 5 is directed to the radionuclides that may be conjugated to the compound of claim 1; (6) the linker (L) includes the polyalkylene oxide group of Formula (b1); (7) claim 12 includes the reactive moiety (Y) of Formula (4b); (8) claim 13 is directed to the group (M) represented by Formula (4c) wherein M’ is an aryl group, B is a single covalent bond, and E is C=O; (9) claim 14 is directed to the moiety (F1-RC-F2) represented by Formula (4a’) and the group (M) represented by Formula (5a); (10) claim 15 is directed to the reactive moiety (Y) represented by Formula (6a); (11) claim 16 represents peptide (V) comprising the sequence represent by Formula (7a) wherein Bxx = Ala; Axx = an amino acid; Hxx = an amino acid; Lxx1 and Lxx2 each represent a single covalent bond; Z1 = carbonyl containing group; Z2 = -NH2; and X2 = single covalent bond; (12) claim 18 is the peptide (V) represented by Formula (9a) wherein Exx = an amino acid with an amino group containing side chain and Gxx = Glu; (13) claim 19 is the peptide (V) represent by the Formula (10f); and (14) claim 22 is Applicant’s elected species supra represented by Formula (7a) in claim 16 wherein Z1 = acetyl; Lxx1 = bond; Axx = Asp; Bxx = Ala; Cxx = Trp; Dxx = His; Exx = Orn; Fxx = Gly; Gxx = Glu; Hxx = Thr; Lxx2 = bond; Z2 = NH2; and X2 = bond. Claims 1-5, 8, 12-16, 18, 19, and 22-24 read on the elected species.
Initially, Applicant’s elected species was searched. However, no prior art was found which could be used to reject the claims. Thus, the search was expanded to all the species of claim 22 and still no prior art was found to reject the claims. The search was once again extended, prior art was found to reject the claims. Thus, the search was not further extended.
Note(s): The search was not extended beyond claims 1-5, 8, 12-16, 18, 19, and 22-24.
Withdrawn Claims
Claims 6, 7, 9-11, 17, 20, 21, and 25-33 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention/species.
Information Disclosure Statement
The information disclosure statement filed 7/18/2023 and 12/15/2025 were considered.
Double Patenting Rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 8, 12-16, 18, 19, and 22-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 16-21, and 31-43 of copending Application No. 17/781,687 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to compounds comprising a peptide comprising vector conjugated to a reactive moiety and payload wherein the reactive moiety may incorporate a linking moiety (see copending independent claims 1, 6, 16, 18, and 19, for example). Thus, both inventions disclose
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
112 Second Paragraph Rejections
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 1-5, 8, 12-16, 18, 19, 23, and 24 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.
Claims 1-5, 8, 12-16, 18, 19, 23, and 24: Independent claim 1 is ambiguous for the following reasons: according to MPEP 2173.05(h), while a Markush grouping may include a large number of alternatives, and not necessarily be indefinite, in certain circumstances, a Markush group may be so expansive that a skilled artisan cannot determine the metes and bounds of the claimed invention. In the pending claims, the invention is directed to compounds of Formula (1): V-(Y-P)n wherein V is any peptide comprising a vector; P is any group comprising one or more payloads; and Y is any reactive group. In claim 2, P is P1 or P1-L, (P1-L)n’K or (P1)n’-K wherein P1 is any payload; L is any linker that is optionally cleavable; and K is any branching group that is bonded to Y and two or more linkers or payloads. P1 is any substance derived from a chromophore; any substance derived from a labeling moiety optionally including a radionuclide; any moiety comprising an optionally substituted conjugated diene, any optionally substituted tetrazine, an substituted alkyne or azide, any optionally substituted dibenzocyclooctyne, any optionally substituted trans-cyclooctene, any optionally substituted bicyclo[6.1.0]nonyne, any optionally substituted aldehyde, any optionally substituted ketone, any optionally substituted halogenoacetamide, an optionally substituted maleimide, or any optionally substituted or protected thiol; any moiety derived from an anti-neoplastic agent; any moiety derived from an immunomodulatory agent; any moiety derived from an anti-infectious disease agent; any moieties derived from radioisotopes; any moieties derived from metabolites; any moieties derived from pharmaceutically acceptable salts and prodrugs; or any moieties comprising one or more solubilizing groups.
Possible K values include those present in claims 9-11. Possible Y values include those of Formulae F1-RC-F2 and (F1-RC-F2)-M wherein F1 is a single bond, an atom, or any group of atoms; RC is any reactive center; F2 is any atom or group of atoms; and M is any group. F1-RC-F2 may be any of the structures appearing in claims 14 and 15, but not limited to structures therein. Possible peptides include, but are not limited to those, in claims 16-19.
Thus, the claim encompasses compounds defined by multiple Markush groups and subgroups thereof. As a result, pending claim 1 encompasses a massive number of distinct alternative members such that one skilled in the art cannot determine the metes and bounds of the claim. Hence, due to an inability to envision all of the compounds defined by the Markush groups, the claim is deemed to be vague and indefinite.
Since claims 2-5, 8, 12-16, 18, 19, 23, and 24 depend upon independent claim 1 for clarity, those claims are also vague and indefinite.
Claims 1-5, 8, 12-16, 18, 19, 23, and 24: Independent claim 1 is ambiguous because it is unclear what particular peptide sequence Applicant is referring to that also comprises a vector and is capable of interacting with a fragment crystallizable region of an antibody that may optionally be incorporated into a Fc-fusion protein. In addition, the claim is ambiguous because it is unclear what one or more payload groups Applicant is referencing that are compatible with the desired peptide comprising a vector and reactive group wherein the reactive moiety reacts with the side chain of one of the amino acids present in V. Since the clarity of claims 2-5, 8, 12-16, 18, 19, 23, and 24 depend upon the clarity of independent claim 1, those claims are also vague and indefinite.
Claim 1: The claim recites the limitations "the fragment crystallizable Fc region" (lines 5-6) and “the side chain of an amino acid” (line 9). There is insufficient antecedent basis for these limitations in the claim.
Claim 2: The claim recites the limitation "the following formulae" (line 2). There is insufficient antecedent basis for this limitation in the claim. In addition, claim 2 is ambiguous because it is unclear what branching group Applicant is referring to that is compatible with the pending invention.
Claim 3: The claim is ambiguous for the following reasons. It is unclear what is the actual substance being claimed that s derived from a chromophore or derived from a labeling moiety or derived from diene, tetrazine, alkyne, azide, dibenzocyclooctyne, trans-cyclooctene, bicyclo[6.1.0]nonye, aldehyde, ketone, halogenoacetamide, maleimide, or a thiol. Still, it is unclear what particular substances are being claims that are derivatives of an anti-neoplastic agent, an immunomodulatory agent, and anti-infectious disease agent, radioisotopes, metabolites, pharmaceutical salts, prodrugs, and solubilizing groups.
Claim 12: The claim recites the limitations "the following formulae" (line 2) and “the electron density” (line 9). There is insufficient antecedent basis for these limitations in the claim.
Claim 13: The claim recites the limitations "the following formulae" (line 2) and “the general formula” (line 13). There is insufficient antecedent basis for these limitations in the claim. In addition, the claim is ambiguous because it is unclear what are the actual moieties (M’) being claimed that are derived from succinimide or an aryl group having 6, 10, or 14 ring members and 1, 2, or 3 condensed rings or a heteroaryl group having 5-20 ring members, 1, 2, or 3 condensed rings and 1-4 heteroatoms.
Claim 14: The claim recites the limitation "the following formulae" (lines 2 and 3). There is insufficient antecedent basis for these limitations in the claim.
Claim 15: The claim recites the limitation "the following formulae" (line 2). There is insufficient antecedent basis for this limitation in the claim.
Claim 16: The claim recites the limitation "the following formulae" (lines 2, 11, and 71). There is insufficient antecedent basis for this limitation in the claim. In addition, the phrase "such as" (see lines 14, 15, 16, 21, 22, 24, 29-30, and 32) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 16: A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 16 recites the broad recitation “Axx2 amino acid” (line 15) , and the claim also recites “preferably Gly” (line 15) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 16: The claim is ambiguous because it is unclear what specific substance Applicant is referring to that is a group derived from a compound containing a conjugation group, an alkyne, an azide, a bromoacetamide, a maleimide, and a thiol (see lines 37-40 and 52-54). In addition, the claim is ambiguous because it is unclear what substances Applicant is referencing that are derived from a compound containing a conjugation group (see lines 64-65 and 69-70).
Claim 18: The claim is ambiguous because the sequence appearing in line 3 is not readable. Specifically, some of the text is missing or overlaps other text.
Claims 23 and 24: The claims are ambiguous for the following reasons. According to MPEP 2173.05(p), a single claim directed to both a product and method steps for using such product is indefinite. In particular, the claim is indefinite because while the claim initially sets forth a product (kit), the claim limitation is not directed to the product, but rather to actions involving the product which creates confusion as to when direct infringement occurs. Specifically, it is unclear whether infringement occurs when one has a kit comprising the compound of claim 1 and a buffer or when the antibody fragment is incorporated into a Fc-fusion protein (claim 23) or when the compound of claim 1 is immobilized on a solid phase matrix via a covalent linkage obtained by click reaction between an alkyne and azide via covalent linkage obtained by reaction between a thiol and an acetamide, via covalent linkage obtained by reaction between a derivative of TCO and a derivative of TZ, or via covalent linkage obtained by reaction between a thiol and maleimide.
Claim 24: The claim is ambiguous because it is unclear what derivative of TCO and TZ Applicant is referring to that result in the desired linkage of claim 24.
103 Rejection
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 1-5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Tornesello et al (Molecules, 2017, Vol. 22, No. 1282, pages 1-21).
Independent claim 1 is directed to a compound of Formula (1) V-(Y-P)n wherein V is a peptide comprising a vector; P is a group comprising one or more payloads P1; Y is a reactive moiety that is covalently attached to the side chain of an amino acid in V; and n is an integer from 1 to 3.
Claim 2 is directed to the compound of claim 1 wherein P = P1 or P = Formula (2a), (2b), or (2c) as set forth therein.
Claim 3 is directed to the compound of claim 1 wherein P1 is one of the moieties disclosed therein.
Claim 4 is directed to a compound of claim 1 wherein P1 = a chelating agent optionally comprising a radionuclide.
Claim 5 is directed to the compound of claim 3 wherein a radionuclide therein is present.
Tornesello et al is directed to bioactive peptides comprising chelating agents that are used for imaging and therapy. In particular, Tornesello et al disclose that the peptide conjugate comprises an amino acid sequence (that may have PEG substituents attached thereto) which to a linker-chelator-nuclide. Both the amino acid residues and linker may have PEG substituents attached thereto (see entire document, especially, abstract; page 2, Figure 1; pages 2-3, Table 1). Possible chelators that may be utilized include N2S2, N3S, N4, HNIC (page 9, ‘3.2.1 Technetium Chelators”), DTPA and analogs thereof (page 11, Figure 3), DOTA and analogues thereof (page 12, Figure 4). Possible radionuclides compatible with Tornesello et al include 90Y, 177Lu, 188Re, 67Cu, 212Bi, 213Bi, 211At, 225Ac, 99mTc, 111In, 68Ga, 64Cu, and 131I (page 9, “3.2 Radionuclides”). The peptide conjugates may have prosthetic groups present (page 14, second complete paragraph and Figure 5)
Hence, both Applicant and Tornesello et al disclose a composition comprising a peptide conjugated to a reactive moiety (e.g., Glycosil, page 2, Figure 1 or any moiety that Tornesello et al disclose that may bind to another component (insertion of non-natural amino acids into the peptides, conjugation of glycosylated moieties or poly ether compounds pages 3-4)) and a linker-payload group (PEG containing group-chelators) that optionally contains a radionuclide. In Figure 1 (page 2) one may have a linear, a multimeric, or cyclic targeting peptide with the various components present.
For the reasons set forth above, both Applicant and Tornesello et al disclose overlapping subject matter. Thus, the limitations of claims 1-5 and 8 are met.
Claim Objection
Claim 22 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Comments/Notes
It should be noted that the full scope of claim 22 was searched and no prior art was found which could be used to reject the claims.
Applicant is respectfully requested to thoroughly review the claims and remove the bullet, hash marks, open circles, and so forth from the claims. Applicant’s attention is directed to MPEP 608.01(i) which sets forth that where a claim contains a plurality of elements/steps, each element/step of the claim should be separated by a line indentation (for example, see claims 3, 13, 16, and 18).
Conclusion
Claims 1-5, 8, 12-16, 18, 19, and 22-24 are rejected. Claim 22 is objected. Claims 6, 7, 9-11, 17, 20, 21, and 25-33 are withdrawn.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G. 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.
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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
June 12, 2026
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