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 . 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.
Claim Rejections - 35 USC § 112 –
Indefiniteness, Indefinite Language,
Broad to Narrow Limitations, Lack of Antecedent Basis
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 1-24, 27-28 and 31 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.
Regarding broad to narrow limitations, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 1 recites the broad recitation “urokinase Plasminogen Activator Receptor”, and the claim also recites “(uPAR)” which is the narrower statement of the range/limitation.
In the present instance, claim 4 recites the broad recitation “aminoisobutyric acid”, and the claim also recites “(Aib)” which is the narrower statement of the range/limitation.
In the present instance, claim 9 recites the broad recitation “targeted radionuclide therapy”, and the claim also recites “(alpha, beta-emitters or auger)” which is the narrower statement of the range/limitation.
In the present instance, claims 13 and 19 recite the broad recitation “TRAP”, and the claim also recites “(PRP9)” which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The Applicant is encouraged to remove the parentheses from the claims, at each instance of occurrence.
Regarding indefinite language, and further regarding claims 1 and 4-5, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Further regarding indefinite language, and further regarding claims 7-9, 12-13, 17-19 and 24, the phrases "in particular" and “preferably” render the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The Applicant is encouraged to remove the indefinite language from the claims, at each instance of occurrence.
Regarding lack of antecedent basis, claim 4 recites the limitation "natural amino acids" in line two. There is insufficient antecedent basis for this limitation in the claim.
Further regarding lack of antecedent basis, claim 5 recites the limitation "synthetic amino acids" in line two. There is insufficient antecedent basis for this limitation in the claim.
The Applicant is encouraged to amend the claims, to correct the lack of antecedent basis, at each instance of occurrence.
Claim Rejections - 35 USC § 103 - Obviousness
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.
Claim(s) 1-13, 20, 24, 27-28 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Cuthbertson et al (USP 8,568,689 B1).
Cuthbertson taught contrast agents for detection of the Urokinase Plasminogen Activator Receptor (uPAR). More specifically, Cuthbertson related to contrast agents comprising a peptidic vector binding to the uPAR, and labelled with an imageable moiety [abstract]. The peptide sequence comprised Z1—W1—X0-Cha-Phe-Ser-Arg-Tyr-Leu-Trp-Ser-X6—W2—Z2 [claim 9], where Z was an imageable moiety capable of detection either directly or indirectly in in vivo diagnostic imaging, and wherein Z was chelated with a chelating agent Y [col 6, lines 42-50; col 6, line 66 to col 7, line 7]; W was a monodisperse polyethylene glycol (PEG) building block comprising 1 to 10 units of said building block [col 3, lines 28-40]; and, X0 represented 1-5 amino acids [see claim 1], including Glu [col 2, line 55], wherein the bonding was covalent [col 5, lines 3-12; see also col 6 at lines 39 and 52]. PEG acted as a spacer, with biomodifier properties, linking the imageable moiety to the peptidic vector [col 3, lines 58-62].
Claim 1 is rendered prima facie obvious over the teachings of Cuthbertson, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results. In the instant case, all the claimed elements (e.g., uPAR-targeting peptide conjugate comprising, radionuclide, chelating agent, linker) were known in the prior art (e.g., Cuthbertson) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would yield nothing more than predictable results (e.g., a uPAR-targeting peptide conjugate) to one of ordinary skill in the art. MPEP 2143.A.
Cuthbertson reads on claims 1-2, 6, 10, 11.
Claims 3-4 are rendered prima facie obvious because Cuthbertson taught β-alanine [claim 1].
Claim 5 is rendered prima facie obvious because Cuthbertson taught cyclohexylalanine [claims 6 and 9].
Claims 7-9 are rendered prima facie obvious because Cuthbertson taught PET and SPECT imaging [col 4, line 59]; 68Ga [col 6, line 49]; and, 99mTc [col 5, line 24]; 177Lu [col 5, line 26].
Claim 12 is rendered prima facie obvious because Cuthbertson taught a binding affinity of < 50 nM, preferably < 25 nM [col 10, lines 4-29].
Claims 13 and 20 are rendered prima facie obvious because Cuthbertson taught DOTA [col 7, line 5]. At Example 6, DOTA was included in the uPAR-peptide [see also col 26, lines 19-33].
Claims 24 and 28 are rendered prima facie obvious because Cuthbertson taught colorectal cancer [col 11, lines 4-5].
Claim 27 is rendered prima facie obvious because Cuthbertson taught a pharmaceutical composition [col 11, lines 10-16].
Claim 31 is rendered prima facie obvious because Cuthbertson taught atherosclerosis [col 11, line 9].
Claim Objections
Claims 14-19 and 21-23 are 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:
The peptide sequences recited in claims 14-19 and 21-23 appear to be free of the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CELESTE A RONEY whose telephone number is (571)272-5192. The examiner can normally be reached Monday-Friday; 8 AM-6 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612