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 Acknowledgment s are made that this application claims the priority to the following: . Information Disclosure Statement The information disclosure statement s (IDS) comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits. Sequence Non-compliance The claims and disclosure are objected to because of the following informalities: 37 CFR 1.821(c) states that amino acid sequences encompassed by the sequence rules should be disclosed in a sequence listing and 37 CFR 1.821(d) states that the corresponding sequences should be identified by sequence identifier. In the instant case, claims 4-7 and pages 9, 14-15, 19-21, 32-33, 36-38, 42-43, and 46-47 of the specification recites the sequences, but these are not represented by corresponding SEQ ID NOs. Also, it appears that no sequence listing is provided in the disclosure . Proper correction is required. 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 applicant regards as his invention. Claim 1-14 and 18-25 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 pre-AIA the applicant regards as the invention. (i) Claims 1 and 8 recites 18 F, which is a fluorine isotope for nuclide M. However, fluorine does not form a complex with the recited complexing agents. Specification also failed to define binding sites for fluorine isotope on the recited complexing agents or on linker or on peptide. So, it is not clear where fluorine isotope binds in the compound of formula (I). Accordingly, claim 1 and 8, and their dependents are rendered indefinite. (ii) Claims 1 and 3 recites terms “derivative” and/or “analogue” for the recited compounds Specification defined ‘derivative’ as follows: The present disclosure also provides a derivative of the compounds disclosed herein. The derivative may be a compound as disclosed herein wherein the chelator has been modified. For instance, one or more of the carboxylic acid groups of the chelator may be converted into e.g. an ester group or an amide group . The above paragraph is not a definition for the term “derivative”. It is unclear what other compounds applicant intends to cover by the recited derivatives and analogs. There is no provided definition for analogue in the specification , but its dictionary meaning is a substance that is similar, but not identical to another, wherein “similar” is relative word. If a word is relative, then the specification must define its definitive definition. So, t he terms “ derivative ” or “analogue” rendered its scope unclear, since it is not known to the skilled reader which structure are intended to be encompassed by this term. Such as term includes compounds from another compound by a chemical reaction (including compounds which are structurally remote from the starting material), functional derivatives (such as compounds, wherein heteroatoms are exchanged by alternative atoms), compounds with numerous different types of side groups etc. However, there is no clear definition in the application to which extent the compounds might be modified while still being regarded as derivatives. This has the effect that the person skilled in the art cannot decide clearly which compounds are to be covered by said claim and which are not. Accordingly, claims 1 and 3, and their dependents are rendered indefinite. (iii) claims 12, 14 and 23-25 cite “such as” in the claim language. MPEP 2173.05(d) states that “ Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112 , second paragraph should be made. The examiner should analyze whether the metes and bounds of the claim are clearly set forth. Note that the mere use of the phrase "such as" or "for example" in a claim does not by itself render the claim indefinite ”. Accordingly, claims 12, 14 and 23-25 are rendered indefinite. 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 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 of this title, 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 set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. I. Claims 1-14 and 18-25 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao ( China’s Excellent Master’s Thesis Full-Text Database, Medical and Health Science and Technology, issue 10, Page E060-32, October 15, 2018; see applicants filed IDS dated 08/27/2024 ) in view of Hamley (Biomacromolecules, 2014, 15, 1543-1559) and Greenwald (Journal of Controlled Release, 2001, 74, 159-171) . For claim 1 : Zhao teaches the following conjugate: [see page 8]. In the above compound, Gd reads applicants M, cyclic compound, i.e., DOTA reads applicants complexing agent, and the sequence (LRELHLNNN G ) overlaps with applicants SEQ ID NO:1 (LRELHLNNN) . Zhao teach es that peptide used in their experiment has poor water solubility, and so, G ly at C-terminus is added to increase water solubility [see page 6, 2 nd paragraph] . Zhao further teaches ester form of DOTA, wherein carboxylic acid groups are converted to ester form [see Fig. 1-3 in page 15]. The above is interpreted as a composition comprising a compound of DOTA-Linker-Peptide and nuclide Gd. Differences between Zhao and instant claims are as follows: (i) Zhao is silent on applicants linker , which is PEG ; (ii) Zhao has additional Gly at C-terminus of their peptide (LRELHLNNN G ) , whereas applicants claimed SEQ ID NO:1 (LRELHLNNN) does not require Gly. With regard to (i) of above, in fact coupling of PEG to drugs or proteins to improve solubility is well known in the art. For example, Hamley teaches that attachment of PEG to peptides or proteins offers improved water solubility, stability, reduced clearance through the kidneys, and leading to a longer circulation time [see Introduction and, Summary and Outlook]. Greenwald teaches PEG, either bound or not bound to the drug, increases solubility of drug compound [see Introduction ; sections 2 , 3 and 6 ] . So, in this case, PEG increases solubility of both peptide and complexing agent. Therefore, one would be motivated to replace the linker in the teachings of Zhao and arrive at applicants compound of formula 1 with a reasonable expectation of success in light of guidelines provided in the cited art. With regard to (ii) of above, according to teachings of Zhao , the purpose of additional Gly at C-terminus to increase solubility of peptide. However, as explained above under (i), the PEG is more superior to Gly, because PEG can increase solubility of both peptide and complexing agent. In addition, PEG also increase stability of the compound. Therefore, a skilled person in the art prefer PEG over Gly in the compound of formula I. For claim 2 : In the conjugate in the teachings of Zhao , see above under For claim 1 , the ratio is equals to one. For claim 3 : Zhao teaches DOTA, which is nothing but applicants chelator in the formula Ia. However, Zhao is silent on PEG group in the formula Ia. See advantages of PEG and the reasoning provided above under For claim 1 . For claims 4-8 : As explained in For claim 1 above, the compound of Zhao reads at least applicants claimed Cmpd 5. The differences are addressed in For claim 1 above. For claim 9 : Zhao teaches their conjugate is dissolved in water and pH is adjusted to 6.5-7 [see page 16]. Water can be a diluent or carrier or excipient. For claim 10-14 : Though the cited use of composition of claim 1 is intended use, and so, the claimed uses are expected in the conjugate of Zhao . Regardless, Zhao also teaches their probe s are useful to study the MRI of mouse liver fibrosis on type I collagen , which includes diagnosis and monitoring fibrosis [see pages 1-2]. For claims 18-19 : As explained in For claim 1 above, the compound of Zhao reads at least applicants claimed Cmpd 5. The differences are addressed in For claim 1 above. For claims 20-24 : Though the cited use of composition of claim 1 is intended use, and so, the claimed uses are expected in the conjugate of Zhao . Regardless, Zhao also teaches their probes are useful to study the MRI of mouse liver fibrosis on type I collagen, which includes diagnosis and monitoring fibrosis [see pages 1-2]. For claim 25 : Zhao teaches a method of diagnosis and monitoring liver fibrosis by administering Gd-DOTA-peptide probe [see pages I-II]. The differences in the compound or composition is explained under For claim 1 above. Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual components in the composition and their utility as probes diagnosing and monitoring fibrosis etc., were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art. T he motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed subject matter with a reasonable expectation of success. Further, t he strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983). In the instant case, one is simply substituting a PEG linker from Hamley and Greenwald into the composition of Zhao . II. Claims 1-14 and 18-25 are rejected under 35 U.S.C. 103 as being unpatentable over Velikyan ( Nuclear Medicine and Biology, 2014, 41, 728-736 ; see applicants filed IDS dated 12/16/2022 ) in view of Federico (Angew.Chem.Int.Ed., 2015, 54, 10980-10984 ; see applicants filed IDS dated 12/16/2022 ) and Simecek (ChemMedChem, 2013, 8, 95-103) . For claim 1 : Velikyan teaches a cyclic peptide c[CPGRVMHGLHLGDDEGPC] conjugated either to 2-(4,7-bis(2-(tert-butoxy)-2- oxoethyl)-1,4,7-triazonan-1-yl)acetic acid ( NOTA (tBu)2) or 4-(4,7-bis(2-(tert-butoxy)-2-oxoethyl)-1,4,7-triaza-cyclononan-1-yl)-5-(tert-butoxy)-5-oxopentanoic acid ( NODAGA (tBu)3) via polyethylene glycol link ( PEG2 ) was synthesized and labeled with 68 Ga. , wherein the cyclic peptide has micromolar affinity to collagen and excessive production of extracellular matrix macromolecules such as collagen I and III results in fibrotic tissue [see abstract and Introduction ]. The above synthesized compounds can be represented by the following structures: , wherein Ga is 68 Ga , which reads claimed nuclide [see Fig.1 ; section 3.1 for their preparative methods ] , wherein NO2A (NOTA) and NODAGA reads applicants complexing agents , wherein PEG2 is linker. The above is interpreted as a composition comprising a compound of NOTA (or NODAGA)- Linker-Peptide and nuclide Gd. Difference is that Velikyan silent on applicants SEQ ID NO:1 (LRELHLNNN) . The above deficiency can be cured by the teachings of Federico , which teaches LRELHLNNN , which is identical applicants SEQ ID NO:1 and it has nano molar affinity for collagen I [see Table 1 ]. So, a skilled person it the art would be motivated to replace large cyclic peptide in the teachings of Velikyn with a short peptide of Federico , in light of its high affinity for collagen and its size. For claim 2 : In the conjugate in the teachings of Velikyn , see above under For claim 1 , the ratio is equals to one. For claim 3 : Velikyn teaches NOTA and NODAGA, which are nothing but applicants chelator in the formula Ib and If. For claims 4- 7 : As explained in For claim 1 above, the compound of Velikyn reads at least applicants claimed Cmpd 16 . For claim 8 : Velikyn silent on DOTA. However, based on teaching of Velikyn , it is obvious to extrapolate teachings of Velikyn to DOTA, as it is commercially established chelating agent like NOTA in the imaging, absent evidence to the contrary. Regardless, Simecek teaches that both DOTA and NOTA are most frequently utilized chelators in 68 Ga radiopharmaceuticals [see Fig.1]. Accordingly, these are interpreted as equivalents. Case law holds that the mere substitution of an equivalent (something equal in value or meaning, as taught by analogous prior art) is not an act of invention; where equivalency is known to the prior art, the substitution of one equivalent for another is not patentable. See In re Ruff 118 USPQ 343 (CCPA 1958). For claim 9 : Velikyn teaches their conjugate is dissolved in water and pH is adjusted [see section 2.3 Radiolabeling and in situ stability test ]. Water can be a diluent or carrier or excipient. For claim 10-14 : Velikyn also teaches their probes are useful for imaging and quantification of fibrosis [see title and abstract]. For claims 18 : Velikyn silent on DOTA. However, based on teaching of Velikyn , it is obvious to extrapolate teachings of Velikyn to DOTA, as it is commercially established chelating agent like NOTA in the imaging, absent evidence to the contrary. Regardless, Simecek teaches that both DOTA and NOTA are most frequently utilized chelators in 68 Ga radiopharmaceuticals [see Fig.1]. Accordingly, these are interpreted as equivalents. Case law holds that the mere substitution of an equivalent (something equal in value or meaning, as taught by analogous prior art) is not an act of invention; where equivalency is known to the prior art, the substitution of one equivalent for another is not patentable. See In re Ruff 118 USPQ 343 (CCPA 1958). For claim 19 : As explained in For claim 1 above, the compound of Velikyn reads at least applicants claimed Cmpd 16 . The differences are addressed in For claim 1 above. For claims 20-24 : Velikyn also teaches their probes are useful for imaging and quantification of fibrosis [see title and abstract]. For claim 25 : Velikyn teaches a method of diagnosis and monitoring fibrosis by administering Gd- NOTA (or NODAGA) -peptide probe [see Fig.4-8 ]. The differences in the peptide is explained under For claim 1 above. Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual components in the composition and their utility as probes diagnosing and monitoring fibrosis etc., were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art. The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed subject matter with a reasonable expectation of success. Further, the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983). In the instant case, one is simply replace a large cyclic large peptide in the teachings of Velikyn with a short peptide from the teachings of Federico , in light of its advantages. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SUDHAKAR KATAKAM whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9929 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 8:30 am to 5 pm . 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 . 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. FILLIN "Examiner Stamp" \* MERGEFORMAT SUDHAKAR KATAKAM Primary Examiner Art Unit 1658 /SUDHAKAR KATAKAM/ Primary Examiner, Art Unit 1658