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 12/10/2024 wherein claims 1-30 were canceled and claims 31-33 were added.
Note(s): Claims 31-33 are pending.
Priority
This application is a CON of 18/233,822 filed 8/14/2023 (now abandoned);
18/233,822 is a CON of 18/100,311 filed 1/23/2023 (now abandoned);
18/100,311 is a CON of 16/704,955 filed 12/5/2019 (now abandoned);
16/704,955 is a DIV of 14/855,355 filed 9/15/2015 (now abandoned);
14/855,355 is a CON of PCT/US2014/056177 filed 9/17/2014;
PCT/US2014/056177 claims benefit to PRO 61/990,101 filed 5/7/2014;
PCT/US2014/056177 claims benefit to PRO 61/879,096 filed 9/17/2013; and
PCT/US2014/056177 claims benefit to PRO 61/879,108 filed 9/17/2013.
Note(s): The earliest effective filing date is 5/7/2014 because the pending invention is fully supported in provisional application 61/990,101. It is duly noted that provisional applications 61/879,096 and 61/879,108do not provide support of SEQ ID No: 9. If Applicant is in disagreement with the Examiner’s position, it is respectfully requested that one point to page and line (or paragraph) number wherein support for SEQ ID No: 9 may be found.
Claim Interpretation
Independent claim 31 is directed to a method of selectively labeling a cancer cell in a subject, the method comprising:
intravenously administering a peptide conjugate to the subject wherein the peptide conjugate comprises an indocyanine green conjugated to a peptide having at least 90% sequence identity to SEQ ID NO: 9; and
allowing binding the peptide conjugate selectively to the cancer cell thereby selectively labeling the cancer cell.
Independent claim 32 is directed to a pharmaceutical composition comprising:
a buffer wherein the buffer comprises histidine;
a sugar alcohol wherein the sugar alcohol comprises mannitol; and
a peptide conjugate wherein the peptide conjugate comprises indocyanine green conjugated to a peptide having at least 90% sequence identity to SEQ ID NO: 9, the compositions has an ionic strength of less than 50 mM.
Independent claim 33 is directed to a lyophilized composition comprising:
a peptide conjugate wherein the peptide conjugate comprises indocyanine green conjugated to a peptide having at least 90% sequence identity to SEQ ID NO: 9;
a buffer wherein the buffer comprises histidine; and
a sugar alcohol wherein the sugar alcohol comprises mannitol.
Specification
The disclosure is objected to because of the following informalities: (1) the sequence identification numbers are missing in the specification. Applicant is respectfully requested to incorporate the “SEQ ID No:” information in all appropriate portions of the disclosure. (2) On pages 271-272, portions of the charts are missing.
Appropriate correction is required.
Double Patenting Rejections
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.
Claim 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 24, and 27 of U.S. Patent No. 12,048,732. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to selectively labeling cancer cells by intravenously administering a conjugate comprising indocyanine green and SEQ ID No: 9. Patented claim 1 discloses that a detectable agent in combination with SEQ ID No: 9 is administered to a subject intravenously (see patented claim 2) and cancer cells are selectively labeled (see patented claim 1). While the patented claims do not specifically list indocyanine green as the detectable agent, review of the patent disclosure (column 31, line 24) specifically sets forth that indocyanine green is a detectable agent encompassed by the pending invention. Therefore, the general terminology ‘detectable agent’ in the patented claims covers indocyanine green. Hence, the claims are directed to overlapping subject matter.
Claims 31-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 10, and 14-18 of U.S. Patent No. 12,048,750. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to intravenously administered compositions comprising SEQ ID No: 9, histidine, mannitol, and indocyanine green (see patented claim 1) wherein the ionic strength of the composition is less than 10 mM (see patented claim 10). The composition may be lyophilized as set forth in patented claim 14. While the patented claims do not specifically state that cells are selectively labeled, both inventions use identical compositions that are administered intravenously to a subject. Thus, according to MPEP 2112.01, products of identical chemical composition cannot have mutually exclusive properties, thus, since both inventions have overlapping compositions that are administered intravenously, then in both instances cancer cells will be selectively label. Hence, the inventions disclose overlapping subject matter.
Claim 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, and 7 of U.S. Patent No. 11,559,580. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims involve selectively labeling cancer cells by intravenously administering compositions comprising indocyanine green conjugated to a peptide having a least 90% sequence identity to SEQ ID No: 9 (see patented claim 1). Thus, the inventions disclose overlapping subject matter.
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.
Claim 31 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.
Claim 31: The claim is ambiguous because of the phrase ‘binding the peptide conjugate selectively to the cancer cell’. Specifically, the phrase is confusing because it is not the person that administers the intravenous composition to the subject that binds the peptide conjugate to the cancer cell, but one allows time for the conjugate to bind cancer cells. Did Applicant intend to replace the phrase with ‘allowing the conjugate to bind the cancer cell’?
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.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Olson (US Patent No. 9,944,683).
Independent claim 31 is directed to a method of selectively labeling a cancer cell in a subject, the method comprising:
intravenously administering a peptide conjugate to the subject wherein the peptide conjugate comprises an indocyanine green conjugated to a peptide having at least 90% sequence identity to SEQ ID NO: 9; and
allowing binding the peptide conjugate selectively to the cancer cell thereby selectively labeling the cancer cell.
Olson is directed to chlorotoxin variants and conjugates compositions and method of using the variants and compositions (see entire document, especially, abstract). In particular, Olson discloses that the chlorotoxin variant may be SEQ ID No: 4 which is equivalent to Applicant’s SEQ ID No: 9 (Figures 1 and 2, SEQ ID No:4; columns 4-5, bridging paragraph). Olson’s SEQ ID No: 4 is also known as K15R_K23R CTX (Figures 1 and 2).
The modified chlorotoxin may be conjugate to a fluorescent label (column 2, lines 38-50). Tissue imageable by chlorotoxin involve containing tissue imageable by chlorotoxin with a chlorotoxin conjugate. The tissue may be cancerous tissue (columns 2-3, bridging paragraph; column 3, lines 4-20). Possible fluorescent moieties include cyanine compounds which have relatively high extinction coefficients and favorable fluorescence quantum yields (column 7, lines 42-54). Indocyanine green is listed as a suitable fluorophore for the invention of Olson (column 8, line 50).
For the reasons set forth supra, the limitations of claim 31 are meet as both Applicant and Olson disclose inventions directed to labeling a cancer cell by administering a conjugate comprising indocyanine green conjugated to a peptide having at least 90% sequence identity to SEQ ID No: 9.
Note(s): Olson was filed November 9, 2012 as Serial No. 13/673,779. The document is a continuation of PCT/US2011/023797 filed February 4, 2011 which is prior to Applicant’s effective filing date for the pending invention.
Comments/Notes
In the amendment filed 12/10/2024, Applicant inadvertently omitted the claim identifiers for the newly added claims. Applicant is respectfully reminded that all amendments should include claim identifiers.
The Examiner is aware of numerous applications with similar subject matter. However, while every effort has been made to review all applications containing overlapping subject matter, some applications may have been missed. Thus, Applicant is respectfully requested to submit all serial numbers of applications containing overlapping subject matter for review by the Examiner.
Conclusion
Claims 31-33 are rejected.
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 24, 2026
Prosecution Insights