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 .
Claims 1-15 are pending.
Claims 7-9 and 13-15 are withdrawn.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/03/2025 has been entered.
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.
Claims 1-6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over EBERT (Cyanine dyes as contrast agents for near-infrared imaging in vivo: acute tolerance, pharmacokinetics, and fluorescence imaging. Journal of Biomedical Optics. 2011.) in view of WANG (Near-Infrared Optical Imaging of Integrin AvB3 in Human Tumor Xenografts. Molecular Imaging. 2004).
EBERT teaches the following compound for tumor imaging (abstract):
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(figure 1), which reads on this section on the contrast agent aspect of instant claim 12 (see below),
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.
EBERT does not teach attaching a targeting agent.
WANG teaches the following compound, in particular the Cyclic RGDfK peptide below:
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(figure 1), which reads on the targeting agent aspect in claim 12. Cyclic RGDfK peptide has the following structure:
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. Cyclic RGDfK peptide targets the αVβ3 integrin which assists in targeting tumors (Page 350, paragraph 3). The composition was injected into mice (abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to conjugate a targeting agent, such as Cyclic RGDfK peptide as taught by WANG, to the imaging agent disclosed by EBERT. The person of ordinary skill in the art would have been motivated to make those modifications, because Cyclic RGDfK peptide allows the imaging agent to be targeted to the correct location and reasonably would have expected success because both references are in the same field of endeavor, such as tumor imaging agents.
Claims 1-6 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over EBERT (Cyanine dyes as contrast agents for near-infrared imaging in vivo: acute tolerance, pharmacokinetics, and fluorescence imaging. Journal of Biomedical Optics. 2011.) and WANG (Near-Infrared Optical Imaging of Integrin AvB3 in Human Tumor Xenografts. Molecular Imaging. 2004) in view of BERKMAN (US 20070219165).
EBERT and WANG teach Applicant’s invention as discussed above.
EBERT and WANG do not teach adding a pharmaceutical excipient or a diagnostic kit.
BERKMAN teaches a fluorescent compound that is used for imaging (abstract) that has a pharmaceutically acceptable excipient, carrier or dilutant (claim 24) and that is further used in a diagnostic kit (claim 25).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a pharmaceutical excipient and a diagnostic kit. The person of ordinary skill in the art would have been motivated to make those modifications, because a carrier and diagnostic kit allows the composition to be readily available for administration to subjects for therapeutic purposes, and reasonably would have expected success because all references are in the same field of endeavor, such as fluorescent compounds.
Response to Arguments
Applicant argues in the remarks that it would not be obvious to combine the teachings of the
references due to the unpredictability of the art and that there would be no expectation of success.
Examiner does not find the argument persuasive because obviousness does not require
complete predictability and less preferred embodiments do not constitute a teaching away. In the
instant case, both compounds are used as dyes for tumors and whether the dye is conjugated or
unconjugated both are preforming the same function of highlighting a specific area desired for medical
purposes. Dyes are commonly chosen in the art to perform this specific purpose.
Additionally, it would have been obvious to the person of ordinary skill in the art at the time the
invention was made to conjugate a targeting agent, such as Cyclic RGDfK peptide as taught by WANG, to
the imaging agent disclosed by EBERT. The person of ordinary skill in the art would have been motivated
to make those modifications, because Cyclic RGDfK peptide allows the imaging agent to be targeted to
the correct location and reasonably would have expected success because both references are in the
same field of endeavor, such as tumor imaging agents.
Furthermore, the unexpected results in comparison to LATTUADA are not persuasive because in order to overcome a prima facie case of obviousness, it is incumbent upon the Applicant to provide
comparative test evidence that demonstrates unexpected superiority of the claimed composition sversus the closest prior art compositions, and not simply an advantage predictable from the prior art.
See In re Chapman, 148 USPQ 711, 715 (CCPA, 1966). Moreover, such proffered comparisons must be
commensurate in scope with the breadth of the claims. See In re Clemens, 206 USPQ 289, 296 (CCPA,
1980) and In re Coleman, 205 USPQ 1172, 1175 (CCPA 1980). In the instant case, the comparative results provided are towards prior art, LATTUADA, that was not used to reject the instant claims. EBERT and WANG was used to reject the instant claims.
The affidavit under 37 CFR 1.132 filed 11/03/2025 is insufficient to overcome the rejection of
claims 1-6 and 12 based upon EBERT in view of WANG as set forth in the last Office action because:
Applicant argues in the affidavit that the claimed invention has an unexpected property, such as
increased internalization capability.
Examiner does not find the argument persuasive because, the fact that the inventor has
recognized another advantage which would flow naturally from following the suggestion of the prior art
cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte
Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In the instant case, although ERBERT and WANG
do not teach this advantage, it would be inherent that the prior art’s composition would have the same
chemical/physical properties as argued by Applicant, because the prior art has the same components as
claimed by Applicant, unless proven otherwise.
The unexpected results in comparison to LATTUADA are not persuasive because in order to
overcome a prima facie case of obviousness, it is incumbent upon the Applicant to provide comparative
test evidence that demonstrates unexpected superiority of the claimed compositions versus the closest
prior art compositions, and not simply an advantage predictable from the prior art. See In re Chapman,
148 USPQ 711, 715 (CCPA, 1966). Moreover, such proffered comparisons must be commensurate in
scope with the breadth of the claims. See In re Clemens, 206 USPQ 289, 296 (CCPA, 1980) and In re Coleman, 205 USPQ 1172, 1175 (CCPA 1980). In the instant case, the comparative results provided are
towards prior art, LATTUADA, that was not used to reject the instant claims. EBERT and WANG was used
to reject the instant claims.
Furthermore, the claims are towards a composition, not towards a method of making or a
method of using the composition within a patient that would be tied to the results after administration
into said patient.
Applicant argues in the affidavit that it would not be obvious to combine the teachings of the
references due to the unpredictability of the art and that there would be no expectation of success.
Examiner does not find the argument persuasive because obviousness does not require
complete predictability and less preferred embodiments do not constitute a teaching away. In the
instant case, both compounds are used as dyes for tumors and whether the dye is conjugated or
unconjugated both are preforming the same function of highlighting a specific area desired for medical
purposes. Optimal dyes, using their optical properties and ways of highlighting the tumors are
commonly chosen in the art to perform this specific purpose.
The Examiner finds Applicant’s argument unpersuasive, because in response to applicant's
arguments against the references individually, one cannot show nonobviousness by attacking references
individually where the rejections are based on combinations of references. See In re Keller, 642
F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In this instance, as discussed in the rejection, it would have been obvious to the person of ordinary skill
in the art at the time the invention was made to conjugate a targeting agent, such as Cyclic RGDfK
peptide as taught by WANG, to the imaging agent disclosed by EBERT. The person of ordinary skill in the
art would have been motivated to make those modifications, because Cyclic RGDfK peptide allows the imaging agent to be targeted to the correct location and reasonably would have expected success
because both references are in the same field of endeavor, such as tumor imaging agents.
Conclusion
No claims are allowable
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL 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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/S.L.M./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618