DETAILED ACTION
This Office action details a first action on the merits for the above referenced application No. Claims 1-10 are pending in this application.
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 is a 35 USC 371 National Stage filing of international application No. PCT/KR2019/007172 filed on 14 Jun. 2019 and claims benefit under 35 USC 119(e) to foreign application No. 1020190070047 filed on 13 Jun. 2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 24 Aug. 2022 has been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-5 in the reply filed on 11 Dec. 2024 is acknowledged.
Claims 6-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11 Dec. 2024.
Applicant’s election without traverse of species (see below), claims 1-4 in the reply filed on 11 Dec. 2024 is acknowledged.
Claim 5 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11 Dec. 2024.
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Claim Objections
Claim 1 is objected to because of the following informalities: in claim 1, the structure of chemical formula 2 is objected to because the double bond between the R5 and R6 groups is missing. Appropriate correction is required. For the purpose of compact prosecution, chemical formula 2 is being interpreted as having a double bond between the R5 and R6 groups consistent with the elected species.
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.
Claims 1-4 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.
In claim 1, the recitation of “increases renal excretion of the materials remaining after tumor targeting” is indefinite because the recitation is a relative term and it is not what the recitation is in relation to. In addition, “the materials remaining in vivo” is indefinite because it is not clear what materials the recitation is referring to. Claims 2-4 depend to claim 1 and fall therewith.
In the claim 3, the “-L-PEG-(CH2)2CONH-“ is indefinite because claim 3 depends to claim 2 which requires a compound of chemical formula 3 wherein n is an integer from 0 to 114; however the recitation broadly recites PEG, which can be of any length, and so it is not clear if claim 3 further limits claim 2.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The following rejection is based upon art which was found incidental to the search for the elected species. This is not indicative that the entire scope of the claims has been examined; however, the following art is being applied in an effort to promote compact prosecution of the case.
Claim(s) 1 and 4 is/are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by Frangioni et al. (US 2012/0028291 A1; published 2 Feb. 2012; see IDS filed on 24 Aug. 2022).
Regarding claims 1 and 4, Frangioni et al. teach cRGD-MM-19
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(Fig. 7). (This reads on a contrast agent comprising a compound which emits fluorescence such that a tumor signal to background ratio is detected at 1.1 or higher. The compound absorbs light in the 800 region and is of chemical formula 2
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wherein i=+1, Z=C(Me)2; R1=R3=R4=R5=R7=R8=H; R2=R6=(Y)mSO3, m=0; R9=R10=(Y)mN(Me)3+, Y=CH2, m=3; R11=R12=C3 alkyl group, R11 and R12 are linked to form an aliphatic ring; L’=structure linked to O; and TL= cRDG targeting ligand.)
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.
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.
The following rejection is based upon art which was found incidental to the search for the elected species. This is not indicative that the entire scope of the claims has been examined; however, the following art is being applied in an effort to promote compact prosecution of the case.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frangioni et al. (US 2012/0028291 A1; published 2 Feb. 2012; see IDS filed on 24 Aug. 2022), in view of Jamous et al. (Nucl. Med. Biol.; published 2014; see attached 892).
Frangioni et al. teach as discussed above. Frangioni et al. teach charged-balanced imaging agents (see title). Frangioni et al. teach imaging agents that have desirable in vivo properties that result in improved signal to noise background (see abstract). Frangioni et al. teach comparative in vivo behavior of conjugates. The cRDG-MM-19 conjugate has superior imaging properties. The MM-19 based conjugate had a much higher tumor to background ratio at all time points and exhibited rapid renal clearance. cRGD-MM-19 had a TBR of 17.2 (signal to background ratio >1.1) (example 10; Fig. 8). Frangioni et al. teach a reactive linking group having a molecular weight from about 50 to 500 Da that is capable of conjugating with a targeting ligand. The reactive linking group includes at least one reactive group selected from the carboxylic acid group or anhydride or ester thereof ([0148]).
Frangioni et al. do no further teach a contrast agent wherein L’ comprises a PEG linker represented by a compound of the following Chemical Formula 3 or wherein L’=-L-PEG-(CH2)2CONH-.
Jamous et al. teach that PEG spacers of different length influence the biological profile of bombesin-based radiolabeled antagonists (see title). Jamous et al. teach that the introduction of low molecular weight polyethylene glycol spacers may lead to improved pharmacokinetics, in particular to lower kidney uptake and short retention in the kidneys without causing loss of affinity (see pg. 465). Jamous et al. teach MJ1 (PEG2) and MJ2 (PEG4). Conjugation to PEG usually provides improved pharmacokinetics (pg. 467). The pharmacokinetics of the radiopeptides result in impressive tumor to kidney ratios (pg. 468). Pegylation effectively enhances the radiotherapeutic efficacy improving tumor targeting and prolonging tumor retention (pg. 468).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify the contrast agent of Frangoni et al. (cRGD-MM-19) so that the linker L’ comprises a PEG linker of formula 3 wherein L=O and n=2 or 4 or so that the linker L’=-L-PEG-(CH2)2CONH- as taught by Frangioni et al. and Jamous et al. because those PEG linkers would have been expected to advantageously enable lower kidney uptake and short retention in the kidneys.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frangioni et al. (US 2012/0028291 A1; published 2 Feb. 2012; see IDS filed on 24 Aug. 2022), in view of Jamous et al. (Nucl. Med. Biol.; published 2014; see attached 892) and Miwa et al. (US 7,488,468 B1; issued 10 Feb. 2009; see attached 892).
Frangioni et al. teach as discussed above.
Frangioni et al. do not further teach the elected species shown above.
Jamous et al. teach as discussed above.
Miwa et al. teach near infrared fluorescent contrast agent and fluorescence imaging (see title). Miwa et al. teach the compound
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(col. 19). Miwa et al. teach substituted or unsubstituted alkylthio as a suitable monovalent group (col. 35).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify the compound of Frangioni et al. so that a thio group (-S-) replaces the linking oxygen (-O-) as taught by Miwa et al. because the linking thio group would have been expected to provide an equivalent linking group suitable for attaching targeting ligand to the methine of the fluorophore.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN R DONOHUE whose telephone number is (571)270-7441. The examiner can normally be reached on Monday - Friday, 8:00 - 5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on (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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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
/SEAN R. DONOHUE/
Examiner, Art Unit 1618