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 6/17/2022 wherein claims 5, 14, and 15 were amended; claims 10-12 were canceled; and claims 16-23 was added.
Note(s): Claims 1-9 and 13-23 are pending.
Priority and Priority Document
This application is a 371 of PCT/EP2020/086398 filed 12/16/2020 which claims priority to EPO EP19217647.7 filed 12/18/2019.
Note(s): The earliest effective filing date is 12/18/2019 as the pending invention is fully defined in the priority document.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Interpretation
Independent claim 1 is directed to a polypeptide comprising SEQ ID No. 1.
Claims 14 and 22 are directed to a methods of imaging as set forth therein.
Clarification of the Record
Applicant’s arguments filed regarding the restriction requirement are duly noted. In particular, is asserted that SEQ ID No. 1 is present in the entirety in SEQ ID No. 2 (see amino acids 13-76). Thus, the restriction into Groups requirement in the office action filed 10/8/2025 is WITHDRAWN.
Applicant’s Election
The Examiner acknowledges receipt of Applicant’s elected species filed 11/29/2025. Applicant elected the species wherein the polypeptide comprises SEQ ID No. 1 which is linked to a cyanine dye. Initially, Applicant’s elected species was searched. However, since no prior art was found to reject the claims, the search was expanded to the full scope of the pending claims.
Information Disclosure Statement
The information disclosure statements filed 11/27/2024 and 6/17/2022 were considered.
Statutory Double Patenting Rejection
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-5, 13, 14, 16, 21, and 22 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-5, 13, 14, 16, 21, and 22 of copending Application No. 17/786,669 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Obviousness-type 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, 3, 5-9, 14-20, 22, and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 6-9, 14-20, 22, and 23 of copending Application No. 17/786,669 (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 polypeptides comprising SEQ ID No. 1 and an imaging agent wherein the imaging agent includes all of the components in claim 6. The copending application differs in that it lacks a nanoparticle based moiety. Similarly, claims 15 and 23 differ from the copending application in that it does not exclude “correlated with optical imaging”. Thus, the skilled artisan would recognize that the pending invention encompasses that of the copending application.
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 3-9, 14, 15, 17-20, 22, and 23 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 3 and 4: The claims recite make reference to SEQ ID No. 1 which does not provide antecedent basis for SEQ ID No. 2. Specifically, all of the amino acids of SEQ ID No. 1 are present in SEQ ID No. 2, not reverse. Thus, SEQ ID No. 1 does not comprise or consist of SEQ ID No. 2. The reverse is true, SEQ ID No. 1 is encompassed within SEQ ID No. 2. Thus, there is insufficient antecedent basis for this limitation in the claim.
Claims 6-9 and 17-20: Claims 6 and 9 are ambiguous because of the phrase ‘nanoparticle based moiety. In particular, it is unclear what nanoparticle containing moieties Applicant is referencing that are compatible with the pending invention. Since claims 7-9 and 18-20 depend upon claims 6 and 9 for clarity, those claims are also vague and indefinite.
Claims 14, 15, 22, and 23: Claims 14 and 21 are ambiguous for the following reasons: (1) it is unclear for what purpose(s) the imaging is being done and (2) the method makes reference to some diagnostic device which is vague and indefinite for various reasons including the fact that the apparatus (device) being is unclear along with what and why imaging is being performed. Since claims 15 and 23, respectively depend upon claims 14 and 22, those claims are also vague and indefinite.
Claims 15 and 22: The claims are ambiguous because of the phrase ‘correlated with optical imaging’. The term ‘correlate’ according to Merriam Webster’s Dictionary is defined as ‘describing the relationship between two things that change together or are complementary’. Did Applicant intend to write ‘optical imaging’ instead as the metes and bounds of what is defined as being ‘correlated with optical imaging’ is unclear.
Claims 8 and 19: The claims are ambiguous because of the phrase ‘other radioisotopes of indium, gallium, yttrium, bismuth, radioactinides, and radiolanthanides’. Specifically, not only is it unclear what specifical radioisotopes of the various elements are included and excluded from the phrase and compatible with the pending invention.
112 Fourth Paragraph Rejections
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 3 and 4 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 3 is listed as comprising the amino acid sequence present in SEQ ID No. 2. However, SEQ ID No. 1 does not contain all of the amino acids present in SEQ ID No. 2 and as a result SEQ ID No. 1 does not comprise or consist of SEQ ID No. 2. 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.
Note(s): It is duly noted that SEQ ID No. 2 contains more amino acid residues than that present in SEQ ID No. 1. In addition, amino acid residues 13-76 of SEQ ID No. 2 are those of SEQ ID No. 1. Thus, SEQ ID No. 2 encompasses SEQ ID No. 1, not the reverse.
Comments/Notes
It should be noted that no prior art is cited against the pending invention. However, Applicant must address and overcome the 112 and double patenting rejection above. In particular, the claims are distinguished over the prior art of record because the prior art neither anticipates nor renders obvious the polypeptide of independent claim 1 and uses thereof.
Conclusion
Claims 1-9 and 13-23 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.
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 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
March 16, 2026