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 .
Election/Restrictions
Applicant’s election without traverse of Group II and species of cystatin C and isotonic saline in the reply filed on January 20, 2026 is acknowledged.
Specification
The disclosure is objected to because of the following informalities:
The use of the terms FASTIab™, TRACERIab™, AAALAC®, PETtrace™, CHROMAFIX®, Sep-Pak®, ThermoMixer®, MiniTrap™, Iodo-Gen®, nanoScan®, InterView™, Dionex™, UltiMate™, ProSwift™, Acclaim™, Prism® which are a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
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 20 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 20 recites “cytochrome C, cystatin C, aprotinin, lysozyme, and fragments and variants thereof.” The term “variants thereof” is vague and indefinite. This term could encompass an unlimited number of unspecified modification, rendering the scope of the claim ambiguous. The specification fails to provide any guidance as to what constitutes a “variant” of the recited “fragments.” The specification does not disclose a definition or structural criteria for determining the scope of the term “variants thereof.” One of ordinary skill in the art would not be able to determine the metes and bounds of the claimed invention due to the lack of guidance in the specification and the state of the art.
Clarification and/or amendment is required.
Claim Rejections - 35 USC § 103
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 14, 15, 17, 19, 20, 22, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Tenstad (WO 2010 066843; cited on PTO-892) in view of Olberg et al. (WO 2010 114723; cited on PTO-892).
Tenstad disclose a biomolecule complex comprising a biomolecule and a marker for use as a contrast agen in positron emission tomography (PET)-based imaging methods (claim 1). Regarding claims 14, and 20, Tenstad discloses that the biomolecule can be a ligand protein for megalin/cubilin receptor such as cystatin C (claim 44). Regarding claim 19, Tenstad discloses that the protein such as cystatin C can be freely filtered by the glomeruli and can be absorbed by the proximal tubular cells (page 38, lines 4-9; page 40, lines 15-18). Regarding claim 22, Tenstad discloses that the biomolecule can be consist of a cystatin C polypeptide having a relative molecular mass of about 13 kD (120 amino acids), reads on monomeric form (page 10, lines 1-3; page 22, lines 9-10). Regarding claim 23, Tenstad discloses that the composition comprising the biomolecule complex can further comprise a carrier suitable for the preparation of unit dosage administration (claim 41; page 66, lines 9-11). Regarding claims 14, 15, and 17, Tenstad discloses that the marker can be isotope of fluorine (claim 5).
Tenstad does not disclose a protein is labelled with a 6-[18F]fluoropyridin-3-ylcarboxy group, the 6- [18F]fluoropyridin-3-ylcarboxy group is attached to an N-terminal amino group of the protein or to an amino group present on a lysine sidechain of the protein, and the protein is labelled by acylating said amino group with an ester of 6-[18F]fluoronicotinic acid or with a 6-[18F]fluoronicotinic acid 2,3,5,6-tetrafluorophenyl ester.
Olberg discloses the efficient labeling of biomolecules such as peptide using a 6-[18F]fluoronicotinic acid 2,3,5,6-tetrafluorophenyl ester for radiopharmaceutical applications such as PET imaging (Abstract; page 8, Example 3). Olberg discloses that the 6-[18F]fluoropyridin-3-ylcarboxy group can be attached to an N-terminal amino group of a peptide containing RGD (Arg-Gly-Asp) via ester-mediated N-terminal amide acylation (page 9, Example 4).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to modify the biomolecule complex of Tenstad by labeling the protein with a 6-[18F]fluoropyridin-3-ylcarboxy group for radiopharmaceutical use. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Olberg teaches that 6-[18F]fluoronicotinic acid 2,3,5,6-tetrafluorophenyl ester enables the efficient labeling of proteins. A person of ordinary skill in the art would have been motivated to use this ester in order to achieve rapid labeling and high yields. Accordingly, applying the labeling method of Olberg to the biomolecular complex of Tenstad represents the application of a known method to a known complex to achieve the predictable result of an improved radiotracer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONG HWAN BAEK whose telephone number is (571)272-0670. The examiner can normally be reached Mon - Thu, 9 am - 3 pm ET.
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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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/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618