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 .
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.
Claim(s) 1-4,9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frangioni et al. (US 2016/0347727 A1), in view of Bodapati et al. “Highly soluble perylene diimide and oligomeric diimide dyes combining perylene and hexa(ethylene glycol) units: Synthesis, characterization, optical and electrochemical properties”, Dyes and Pigments 79 (2008) 224–235.
Response to Arguments
Applicant's arguments filed 11/3/2025 have been fully considered but they are not persuasive.
Applicants assert the structure of Frangioni is different for groups R5,R6,R7 and R3 which only include O-alkyl or H different from the claims recited alkyl groups or H.
For the obviousness rejection the R6 and R7 groups are being substituted with ethylene glycol, thus the argument for these groups is moot. With regard to R5 H is recited as an alternative, and H is recited in the same position in the structure claimed. With regard to R3, it is noted that H and methyl are generally considered obvious to substitute for one another unless such a substation results in an unexpected result. With regard to substitution group hydrogen versus methyl group, it is well established that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Wood, 199 U.S.P.Q. 137 (C.C.P.A. 1978) and In re Lohr, 137 U.S.P.Q. 548, 549 (C.C.P.A. 1963). The claimed compounds are so closely related structurally to the homologous compounds of the reference as to be structurally obvious therefore in the absence of any unobviousness or unexpected properties.
Applicants pick on the secondary reference Bodapati for teaching the dyes are soluble in several types of organic solvents and sulfuric acid while their claimed compounds are water soluble. Applicants assert the oligomers of Badopati have a MW not compatible with crossing the BBB, have a hydrophobic core and are neutral while the claimed dyes are cationic. Applicants continue to attack the secondary references use of hexamehthlene glycol as a spacer to make higher MW dyes and the absorption and emission spectra being incompatible with NIRF imaging.
First In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., water solubility of compounds, MW incompatible with crossing BBB and NIRF imaging) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Secondly 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). Clearly only PEG was substituted onto the dyes taught by the primary reference Frangioni from the secondary reference Bodapati. The secondary reference was not used to meet any other limitation other then to show that PEGylation to amine functional groups on dyes was well known in the art at the time of the claimed invention. The entire dye of Bodapati was not bodily incorporated onto the dye of Frangioni. Therefore the properties recited by applicants said to be outside of the their inventions properties are irrelevant. Naturally when PEG oligomer is added to the amine of the dye compound of Frangioni the compound will feature the same properties, including solubility, charge, fluorescence, ability to travel across BBB as it is within the scope of the claimed compounds. Any property, including those not recited in the claims, will be a natural result from the combination.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
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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/JAMES W ROGERS/Primary Examiner, Art Unit 1618