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 11/6/2025 wherein claims 1-56, 62-70, 73-75, and 77 were canceled and claims 57, 60, 61, 71, and 72 were amended.
Note(s): Claims 57-61, 71, 72, 76, and 78-87 are pending.
Priority and Priority Document
This application is a 371 of PCT/GB2020/051442 filed 6/15/2020 which claims benefit to
United Kingdom GB1908573.7 filed 6/14/2019 and United Kingdom GB2004360.0 filed 3/26/2020.
The Examiner acknowledges receipt of certified copies of papers required by 37 CFR 1.55. Both priority documents were submitted on 12/13/2021.
Note(s): The earliest effective filing date is 6/14/2019 because the pending invention is fully supported in United Kingdom GB1908573.7 filed 6/14/2019.
Response to Applicant’s Amendment and/or Arguments
The Applicant's arguments and/or amendment filed 11/6/2025 to the rejection of claims 57-78 made by the Examiner under 35 USC 103 and/or 112 have been fully considered and deemed persuasive-in-part for the reasons set forth below.
It is duly noted that the claims were amended to read on a different sequence from which was previously presented. Specifically, Applicant’s initially presented SEQ ID No. 1 for examination and has now amended the claims to read on SEQ ID No. 7 which includes portions of SEQ ID No. 1.
The search was expanded over newly amended pending independent claim 1.
103 Rejection
The 103 rejection is WITHDRAWN.
112 Second Paragraph Rejections
The outstanding 112 second paragraph rejections are WITHDRAWN because Applicant amended the claims to overcome the rejections.
Claims Not Further Limiting
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 58-61 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. In particular, the claim is not further limiting of the compound because the phrase ‘at least one of imaging and radiotherapy’ is the intended use of the compound, not limitations that further incorporate components into the product (compound). In order to further limit a compound, one should incorporation addition product components, not limit the compound by its intended use which is generally reserved for method of use claims. Similar, the radioactive moieties I claims 58, 59, and 61 do not further limit the product of claim 57. In particular, the compound of claim 57 does not require the present of a radioactive moiety. Lines 46-47 read, ‘ suitable for complexing a radioactive moiety’. The term ‘suitable’ is interpreted as ‘capable of’. If a radioactive moiety is required, it is respectfully suggested that Applicant amend the claim to read, ‘IM is a chelating agent complexed to a radioactive moiety’ (see lines 46-47). 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.
APPLICANT’S ASSERTIONS
It is asserted that the claim has be amended to be in proper dependent form.
EXAMINER’S RESPONSE
Applicant’s response was considered, but deemed non-persuasive for the following reason. Claim 60 depends upon independent claim 57 which does not require a radioactive moiety. For example, independent claim 57, lines 2-3 are the intended used of the compound. The intended use is that the compound is suitable for preparation of an agent useful for imaging and radiotherapy. Independent claim 57, lines 46-47 is directed to a chelating agent that is capable of being complexed to a radioactive moiety. A radioactive moiety is not required. If Applicant is requiring a radioactive moiety, then independent claim 57 should be amended as such. Specifically, it is respectfully suggested that the claim be amended to state that ‘IM is a chelating agent complexed to a radioactive moiety’ (see lines 46-47). Otherwise, the references to radioactive moieties in claims 58, 59, and 61 are not proper.. In regards to claim 60 Applicant is attempting to limit the compound by its intended used (types of imaging and radiotherapy). For the reasons herein, claim 60 as well asl 58, 59, and 61 are not properly formatted.
NEW GROUNDS OF REJECTIONS
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 57-61, 71, 72, 76, and 78 are rejected under 35 U.S.C. 103 as being unpatentable over Iveson et al (US Patent No 9,533,059).
Independent claim 57 is directed to compound of Formula I,
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121
193
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, wherein the variable are defined therein. cMBP is a cMet binding peptide having SEQ ID No. 7 as set forth therein.
Claims 58 and 59 are directed to alpha, beta, and/or gamma emitters.
Claim 60 is directed to PET, SPECT, or radiotherapy.
Claim 61 is directed to various radioactive moieties as set forth therein which includes 18F.
Claim 71 is directed to Q being MIG.
Claim 72 is directed to Z1 = acetyl and Z2 = primary amide.
Claim 76 is directed to a pharmaceutical composition comprising the compound of claim 57 and a biocompatible carrier.
Claim 78 is directed to a pharmaceutical composition further comprising a radioactive moiety.
Iveson et al is directed to peptide radiotracer compositions that are imaging agent composition and comprising radiolabeled c-Met binding peptides. The imaging agents are used for positron emission tomography (PET) imaging in vivo. The c-Met binding peptides are labeled with the radioisotope 18F (see entire document, especially, abstract). The compound has the formula
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26
92
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wherein Z1 is attached to the N-terminus of cMBP and may be MIG; Z2 is attached to the C-terminus of cMBP and may be MIG (column 3, lines 25 and 49-57).
Iveson et al discloses that the metabolism inhibiting group, MIG, is at either the amino terminus (Z1) or carboxy terminus (Z2). In particular, it is disclosed that well known to those skilled in the art is for the peptide amine terminus to be NH(C=O)RG wherein RG is selected from C1-C6 alkyl, C3-C10 aryl groups, or groups that comprise polyethylene glycol (PEG). For the peptide carboxy terminus, well known groups are selected form carboxamide, tert-butyl ester, benzyl ester, cyclohexyl ester, amino alcohol, or a PEG building block (column 4, lines 44-57).
Iveson et al disclose Applicant’s SEQ ID No. 7 , Ala-Gly- Ser-Cysa-Tyr-Cysc Ser-Gly-Pro-Pro-Arg-Phe-Glu-Cysd-Trp-Cysb-Tyr-Glu-Thr- Glu-Gly-Thr-Gly-Gly-Gly-Lys, in column 7, lines 16-17). In column 7, lines 18-26, Iveson et al disclose that for preferred imaging agents, both Z1 and Z2 are MIG. In addition, it is disclosed that when both Z1 and Z2 are MIG, preferably Z1 is acetyl and Z2 is a primary amide or amine. Also, it is disclosed that one may have 18F attached to the compound (column 7, lines 33-39)
A biocompatible carrier may also be present (column 10, lines 26-44).
For the reasons set forth herein, the limitations of claims 57-61, 71, 72, 76, and 78 are met.
Claim Not Further Limiting
Claim 72 is 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 72 does not further limit independent claim 57 because Applicant neither allows the variable Z1 to be acetyl nor the variable Z2 to be a primary amine. In the definitions Z1 and Z2, neither is consistent with the values in claim 72. 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.
Withdrawn Claims
Claims 79-87 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention/species.
Conclusion
Claims 57-61, 71, 72, 76, and 78 are rejected and claims 79-87 are withdrawn.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
March 2, 2026