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. Priority This application filed 08/09/2023 is a National Stage entry of PCT/EP2022/053621, i nternational f iling d ate: 02/15/2022 and claims foreign priority to 21157213.6, filed on 02/15/2021 . Information Disclosure Statement The information disclosure statement s (IDS) submitted on 08/09/2023, 09/18/2023, 01/09/2026 complies with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Status The claim listing filed 08/09/2023 is pending. Claim 12 is cancelled. Claims 3-11 and 13-14 are currently amended. Claims 15-17 are new. Claims 1-11 and 13-17 are pending and under examination. 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 appl icant regards as his invention. Claims 8 and 10 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. Claim 8 recites “ a method of diagnosing ” whilst the body of the claim is directed to the administering of a radiolabelled polypeptide to a subject. “[T] he preamble is not merely a statement of effect that may or may not be desired or appreciated, but rather is a statement of the intentional purpose for which the method must be performed (see MPEP 2111.02(II). In the instant case, it is unclear how the diagnosing is accomplished as the claim only requires administration and there is a disconnect between the preamble and the body of the claim . Appropriate correction is required. Claim 10 recites “a method of establishing a prognosis” whilst the body of the claim is directed to the administering of a radiolabelled polypeptide to a subject. In the instant case, it is unclear how the prognosis is accomplished as the claim only requires administration and there is a disconnect between the preamble and the body of the claim . Accordingly, and as noted above, appropriate correction is required. 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. Claim s 1, 3, 4, 6-11, 1 4, 15 and 17 are rejected under 35 U.S.C. 103 as being obvious over Erik Nordling et al., hereinafter Nordling (Nordling et al., Patent number US 9,982,022B2; Date: 29 May, 2018) in view of Hamideh Sabahnoo et al., hereinafter Sabahnoo (Hamideh Sabahnoo et al., European Journal of Medicinal Chemistry , 127 (2017) 1012-1024) . The applied reference has a common Applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02. Regarding claim 1, Nordling teaches SEQ ID NO: 28 (see Fig 1B) with affinity for HER2 as shown in Example 12 , and hav ing improved stability (see page 29, line 60). SEQ ID NO: 28 AEAKYAKEMRNAYWEIALLPNLTNQQKRAFIRKLYDDPSQSSELLSEAKKLSESQ APK as taught in Nordling, matches (underlined) with 55 amino acid residues (of the total 5 9 residues) of SEQ ID NO: 1 in the instant claim 1 (SEQ ID NO: 1 AEAKYAKEMRNAYWEIALLPNLTNQQKRAFIRKLYDDPSQSSELLSEAKK LSESQ GGGC ) . Please note, amino acids that are identical in the sequence of Nordling (i.e. SEQ ID NO: 28) and the instant claim (SEQ ID NO: 1) are underlined. Nordling teaches that polypeptide variants disclosed , comprise a common scaffold sequence and binding specificity defined by the amino acid sequence within a binding motif (BM) (see SEQ ID NO: 63; page 26). Binding motif corresponds to positions 1-29 of the polypeptide variant sequence (see page 26, line 43). Nordling teaches disclosed polypeptides having 0-3 amino acid residues at the C-terminus . The additional amino acid residues play a role in the binding of the polypeptide, but may equally well serve other purposes, related for example to one or more of the production, purification, stabilization, coupling or detection of the polypeptide. Nordling specifically teaches that s uch additional amino acid residues may comprise one or more amino acid residues added for purposes of chemical coupling. An example of this is the addition of a cysteine residue at the very first or very last position in the polypeptide chain, i.e. at the N- or C-terminus. A cysteine residue to be used for chemical coupling may also be introduced by replacement of another amino acid on the surface of the protein domain, preferably on a portion of the surface that is not involved in target binding (see page 25, column 5; last 2 paragraphs) . Nordling does not teach that the additional amino acids in the C-terminus is GGGC. Sabahnoo teaches anti-HER2 target peptide c onjugated with cysteine-based chelators CGGG (Cys-Gly-Gly-Gly) (see page 1013, last paragraph Introduction ). Sabahnoo teaches target peptide labell ing by incorporating 99m Tc to cysteine-based CGGG (Cys-Gly-Gly-Gly ) (see Abstract). Sabahnoo specifically teaches that chelating moieties comprised of a combination of amino acids have advantages such as easy addition to small peptides during solid phase synthesis and increased receptor binding affinity (see page 1013, last paragraph Introduction ). Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis). Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the HER2 affinity peptide of Nordling , which corresponds to 93.2 % sequence identity to the peptide in the instant application, and introduce CCCG chelator at the C-terminus, as taught in Sabahnoo to create the peptide as in the instant application. One motivated to do so would have a reasonable expectation of success as Nordling identifies SEQ ID NO: 28 as having improved stability (see page 29, line 60) and teaches that additional amino acid residues may comprise one or more amino acid residues added for chemical coupling. An example of this is the addition of a cysteine residue at the very first or very last position in the polypeptide chain, i.e. at the N- or C-terminus. Nordling further teaches , that the cysteine residue to be used for chemical coupling may also be introduced by replacement of another amino acid on the surface of the protein not involved in target binding (see page 25, column 5; last 2 paragraphs) -binding specificity as disclosed in Nordling, is position 1-29 of the polypeptide variant sequence (see page 26, line 43). Thus, one would have recognized that applying the teaching of Nordling , on HER2 affinity peptide , to the method of Sabahnoo , as demonstrated on the HER2 binding peptide, would have yielded predictable results and improved the biological suitability of the peptide as claimed (See MPEP § 2143 I(A)(D)). Regarding claim s 3 , 4 and 15, in addition to rationale as applied in claim 1, Sabahnoo teaches Technetium-99 m ( 99m Tc; half-life, 6.02 h; g ray ¼ 142 keV) (i.e. radionuclide ), in molecular imaging applications , photon energy (nearly ideal for Single Photon Emission Tomography (SPECT)), low cost, widespread availability, and low absorbed-dose burden to the patient (see page 1013, last paragraph Introduction ). Embodiments of the i nstant specification d isclose ‘radionuclide’ suitable for medical imaging as selected from the group consisting of 99m Tc, 51 Mn, 52m Mn, 52 Mn, 186 Re and 188 Re (see page 13, line 14); and ‘radiochelate’ as provided by the nitrogen atoms of three consecutive peptide bonds and a cysteine residue at the C-terminal of the polypeptide (see page 13, line 8). Sabahnoo teaches that peptide conjugated with cysteine-based chelators CGGG (Cys-Gly-Gly-Gly) and CSSS (Cys-Ser-Ser-Ser) (i.e. radiochelate) for labeling with 99m Tc. The 99m Tc-labeling is used in vitro and in vivo for the purpose of finding a favorable HER2-targeted peptide for tumor imaging in vivo (see page 1013, last paragraph Introduction ; page 1020, last paragraph; sections 2.11, 2.12, 3.10; Fig 9). Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the peptide of Nordling , with radiochelate ‘ CCCG ’, and radionucleide 99m Tc , as taught in Sabahnoo , to create the radiolabelled polypeptide in instant claims 3 and 4. One motivated to do so would have a reasonable expectation of success as Sabahnoo asserts that traditional method s for radiolabeling peptides with 99m Tc is via stabilization of [Tc(V)O]3 + metal core with ligands of the so-called N 3 S type . Among heteroatom N 3 S type ligands, chelating moieties comprised of a combination of amino acids have advantages such as easy addition to small peptides during solid phase synthesis and increased receptor binding affinity (see page 1013, last paragraph Introduction ). Thus, one would have recognized that applying the teaching of Nordling to the method of Sabahnoo , would have yielded predictable results and improved the biological suitability of the peptide for medical imaging (See MPEP § 2143 I(A)(D)). Regarding claim s 6 and 17 , including rationale as applied in claim 1, embodiments of the specification disclose pharmaceutically acceptable excipient or carrier as selected to enable or enhance the administration of radiolabeled polypeptide to a subject to be treated or imaged ( see page 14; line 10 ) . Sabahnoo teaches 99m Tc-conjugated peptides diluted in saline and injected via the tail vein into healthy mice (0.1 mL/200 mCi, peptide dose z1 mg), and the biodistribution evaluated at 1, 2, 4, and 24 h postinjection using four mice for each time point (see section 2.9, page 1014) . Regarding claim s 7 , 8, 9, 10, 11 th e Examiner interprets the disjunctive conjunctive ‘or’ as presenting a set of alternatives. So, in claim 7, the Examiner interprets “or” in the claims as -at least one: “ treating ” or “ diagnosing ” or “ prognosing ” . Embodiments of the instant specification disclose “diagnosing” as comprising in vivo imaging and establishing said diagnosis on the basis of the obtained images (see page 16, line 11). The specification discloses “prognosis” as comprising performing the method of in vivo imaging and establishing said prognosis on the basis of obtained images (see page 16, line 16). As disclosed, method of treatment of a mammalian, including human, subject having a cancer characterized by overexpression of HER2, comprising the step of administering a therapeutically effective amount of a radiolabeled polypeptide , comprising a radionuclide suitable for therapy, to said subject . The instant specification does not disclose a therapeutically effective amount (see page 16, line 25). In addition to the rationale for rejection under 35 U.S.C. 103 as applied to claims 1, 3 and 4, Sa bahnoo teaches SKOV3 cell s as HER2 overexpressing (see Fig 2 legend, section 2.5). I maging of HER2 expression in SKOV-3 ovarian cancer xenografts nude mice using 99m Tc-cysteine-triglycine (see Fig 9) i s captured using an E-CAM dual head equipped with a low energy high resolution collimeter (see section 2.12) . Peptides in SKOV3 tumor bearing mice exhibi t considerable tumor uptake at 1 h and 4 h. Images are acquired at 1 h and 4 h after injection (see section 3.10 , Tumor imaging) . Sabahnoo teaches that specific targeted molecule in combination with a suitable radionuclide, result in a selective and sensitive imaging technique (see page 1018, 2 nd paragraph). Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the peptide of Nordling , with radiochelate ‘CCCG’, and radionucleide 99m Tc , as taught in Sabahnoo, and administer the radiolabeled peptide to a mammal (i.e. HER2 overexpressing SKOV3 xenograft model) and acquire images in the body of the mammal (see Fig 9) . One motivated to do so would have a reasonable expectation of success as Sabahnoo specifically teaches that specific targeted molecule in combination with a suitable radionuclide, result in a selective and sensitive imaging technique (see page 1018, 2 nd paragraph). Regarding claim 14, Nordling teaches recombinant expression of a polynucleotide encoding the desired polypeptide. The production may also be carried out using chemical synthesis of the desired polypeptide de nov o (see page 29, column 13) . Nordling teaches polynucleotide encoding a polypeptide or a fusion polypeptide as described. Also encompassed in Nordling is a method of producing a polypeptide or fusion polypeptide as described above comprising expressing such a polynucleotide; an expression vector comprising the polynucleotide; and a host cell comprising said expression vector (see page 27, column 9) . Claims 5, 1 3 and 1 6 are rejected under 35 U.S.C. 103 as being obvious over Erik Nordling et al., hereinafter Nordling (Nordling et al., Patent number US 9,982,022B2; Date: 29 May, 2018) in view of Hamideh Sabahnoo et al., hereinafter Sabahnoo (Hamideh Sabahnoo et al., European Journal of Medicinal Chemistry , 127 (2017) 1012-1024) further in view of Lepareur et al., hereinafter Lepareur (Nicolas Lepareur et al., Current Clinical Applications in Oncology and Promising Perspectives , 6 (2019) 132). Regarding claims 5, 13 and 16, in addition to the rationale for rejection under 35 U.S.C. 103 as applied to the previous claims, Nordling teaches SEQ ID NO: 28 polypeptide with HER2 affinity (see Example 12, see page 29, line 60). Nordling discloses that polypeptides have many applications, for example applications of therapeutic, diagnostic or prognostic significance for disease including cancer (See page 26, column 7 and 8; page 27, column 9; see claims 38 and 39). Sabahnoo teaches radiolabeled HER2 binding polypeptide with radiochelate ‘CCCG’, and radionucleide 99m Tc , and imaging of HER2 expression in SKOV-3 ovarian cancer xenografts nude mice using 99m Tc-cysteine-triglycine (see Fig 9). Sabahnoo does not teach radionuclide suitable for therapy is 186 Re and 188 Re. Lepareur teaches that 186 Re is particular ly suitable for treating small to mid-sized tumors while 188 Re is a better match for larger sized tumors (see Introduction) . Lepareur teaches that peptide receptor radionuclide therapy (PRRT) demonstrate s clinical effectiveness, with some radiopharmaceuticals currently approved and a many more under clinical investigation (see page 8, 2 nd paragraph). Lepareur teaches that Rhenium-188 and technetium-99m exhibit similar chemical properties and represent a “theranostic pair.” Thus, preparation and targeting of 188 Re agents for therapy is similar to imaging agents prepared with 99m Tc, the most commonly used diagnostic radionuclide (see Abstract) . Lepareur teaches that m ore widespread use of 188 Re-radiopharmaceuticals will rely on availability of fully pharmaceutical grade generators and wide clinical proofs of its interest in radionuclide therapy, particularly with the possibility of having a matched theranostic pair with 99m Tc. Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the peptide of Nordling , with the method of Sabahnoo, and use Rhenium therapeutic radionuclide as taught in Lepareur. One motivated to do so would have a reasonable expectation of success as Lepareur specifically teaches that 99m Tc-labeled radiopharmaceuticals serve as a model to prepare 186/188 Re-radiotracers using similar labeling methods (see Introduction). Allowable Subject Matter Claim 2 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. The following is a statement of reasons for the indication of allowable subject matter in claim 2: Claim 2 is directed to the sequence consisting of SEQ ID NO: 1. The closest prior art to SEQ ID NO: 1 is taught in Nordling et al., in SEQ ID NO: 28 and is 93.2% identical to the sequence as claimed . Double Patenting 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 1 is rejected on the ground of nonstatutory double patenting a s being unpatentable over claim s 1 and 8 of U.S. Patent No. US 9,982, 022 B2 . Although the claims at issue are not identical, they are not patentably distinct from each other . Regarding claim 1, reference patent claims sequence comprising SEQ ID NO: 55, selected from an amino acid sequence which has at least 91% identity to SEQ ID NO: 55, wh ich meets the limitations of the instant claim (see claims 1 and claim 8 in reference patent). The critical limitations, that is the peptide sequence, in claim 1 are the same in the conflicting claims 1 and 8. The application depends on the inherent property of the peptide sequence. See MPEP § 2112. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. Although the claims at issue are not identical, they are not patentably distinct from each other. This is a nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. 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