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 .
Information Disclosure Statement
The information disclosure statement filed October 27, 2023 is acknowledged and has been considered by the examiner.
Drawings
The drawings are objected to for the following reasons.
The graphs of Fig. 5C, Fig. 6C, Fig. 7, Fig. 8A, and Fig. 8B provide line graphs comparing the properties of two compositions each. However, the colors and markings of the pair of curves on these graphs are not sufficiently different so as a reader can readily assign the appropriate curve to the correct composition.
The images of Fig. 5B and Fig. 6B are not readily interpretable in their current state. Both figures are associated with a scale intended to communicate the intensity of a measured value. However, the examiner is unable to interpret the meaning of the dark colored regions of the figures as this may correspond to either high or low intensities based on the provided scales.
The text of Fig. 10 is low resolution and difficult to read.
Appropriate correction is required.
Specification
The use of the terms ULTRAVIST and DOTAREM, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear 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.
The examiner objects to the brief descriptions of Figures 11 and 12. Based on the mass spectra displayed in the figures themselves and the expected MW values provided in the brief description, the examiner understands the brief description currently assigned to Figure 11 to describe Figure 12 and the current description of Figure 11 to describe the data presented in Figure 12.
Appropriate correction is required.
Claim Interpretation
The examiner interprets claims 1 and 2 to contain functional language. In claim 1, the phrases “…for diagnosis of vascular disease … and targeting serine protease in a blood vessel wall” recite an intended use of the Gd-DOTA-click-SF composition and do not provide additional structural restriction on the composition. Claim 2 only narrows the scope of the “diagnosis of vascular disease” intended use of claim 1 and does not provide additional structural restriction on the composition. Furthermore, the recitation of “magnetic resonance imaging (MRI) or computed tomography (CT) contrast agent” in the preambles of claims 1 and 2 is also considered to be a description of the intended use as the claims are specifically drawn to the Gd-DOTA-click-SF composition itself. Please note that a recitation of intended use does not distinguish over the prior art since a composition claim covers what the composition is and now what it is used for. A chemical composition and its properties are inseparable (MPEP § 2112.01). Therefore, as long as the prior art teaches the claimed structural features of the composition, it reads on the claim.
Regarding the Gd-DOTA-click-SF nomenclature for the composition, the Gd, DOTA, and click portions are understood to have standard definitions in the art. In light of Figure 1 of the disclosure, “SF” is interpreted as to refer to the phenylsulfonyl fluoride moiety of the molecule presented in Formula 1.
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 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Yan (Yan, X. et. al., Angew. Chem. Int. Ed., 2012) in view of Okamura (Okamura, H. et. al., Circ. Cardiovasc. Imaging., 2014), as evidenced by Bottrill (Bottrill, M., Chem. Soc. Rev., 2006).
Yan teaches a nearly identical molecule to Formula 1, only differing in a DOTA-coordinated europium ion instead of the gadolinium ion of the claimed invention (pg. 3359, Scheme 1). The Yan molecule contains a lanthanide metal coordinated in a DOTA chelating group and the phenylsulfonyl fluoride serine protease activity-based reactive probe moiety. The Yan molecule further teaches combining the aforementioned groups through the same linker moiety as the claimed molecule synthesized by the same azide-alkyne cycloaddition click chemistry.
Yan fails to teach a molecule comprising a coordinated gadolinium ion.
Okamura teaches an MRI contrast agent comprising Gd-DOTA. This molecule, LMI1174 (pg. 694, Fig. 3A), uses gadolinium as the lanthanide for the contrast agent portion of the composition. Like Yan, the lanthanide-DOTA is covalently linked to a targeting moiety. In this way, the structural features of LMI1174 are analogous to those of the claimed Gd-DOTA-click-SF and the composition serves the same purpose as the claimed invention addresses.
As evidenced by Bottrill, both gadolinium and europium are lanthanide metals known to be effectively used in MRI contrast agents (pg. 560, section 2 and pg. 561, section 3.1, respectively). A chemical composition and its properties are inseparable (MPEP §2112.01). Thus, the Yan Eu-DOTA-click-SF composition has the property that it would be capable of use as an MRI contrast agent.
A person of ordinary skill in the art would have recognized that both the Eu-DOTA-click-SF and LMI1174 molecules were capable of serving as contrast agents for imaging. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the serine protease targeting agent of Yan by incorporating the teaching of Okamura and substitute gadolinium into the DOTA group instead of europium because both europium and gadolinium are known to be lanthanide metals used in contrast agents, as evidenced by Bottrill. This would yield the predictable result of a serine protease targeting MRI contrast agent capable of use for imaging vascular disease.
Furthermore, as discussed above, claim 2 is interpreted to require the structure of claim 1. Therefore, the combined teachings of Yan and Okamura, as evidenced by Bottrill, render claims 1 and 2 obvious.
Conclusion
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric P Mosher whose telephone number is (571)272-3258. The examiner can normally be reached Monday-Friday 9am-5pm.
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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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/E.P.M./Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612