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 .
Acknowledgement of Receipt
Applicant’s Response, filed 5/26/26, in reply to the Office Action mailed 3/11/2026, is acknowledged and has been entered. Claims 1, 2, 4, 8-13, 16, 17, 20-24 have been amended. Claim 26 is newly added. Claims 1, 2, 4, 8-14, 16, 17 and 20-26 are pending, of which claims 4, 12, 21, 25 and 26 are withdrawn from consideration at this time as being drawn to a non-elected invention. Claims 1, 2, 8-11, 13, 14, 16, 17 and 20 and 22-24 encompass the elected invention and are examined herein on the merits for patentability.
Response to Arguments
Applicant’s arguments have been fully considered. Any rejection not reiterated herein has been withdrawn as being overcome by claim amendment. The Examiner’s response to Applicant’s arguments is incorporated below.
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.
Claim(s) 1, 2, 8-11, 13, 14, 16, 17, 20 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (Nanoscale, 2019, 11, 2211) in view of Luo et al. (Biomaterials, 2013, 34, 2244-51), for reasons set forth in the previous Office Action.
Response to arguments
Applicant argues that the object of Wang is to achieve drug delivery, not infrared imaging. Applicant asserts that the GA group of GA-Cy7 is significantly different from the -(CH₂)n¹- L-R²² group of the subject application. With the disclosure of Wang, the skilled artisan would not be motivated to replace the GA group of Wang with the -(CH₂)n¹-L-R²² group of the subject application, and would not be able to predict that the fluorescence of the compounds of Formula I or Formula I' of the subject application can be quenched before contacting cancer cells and recovered after recognizing cancer cells. Example 11 of the subject application demonstrates that compound 8 (the same compound of GA-Cy7 in Wang) cannot selectively recognize tumor tissue, indicating that not all compounds with tumor accumulation effects can achieve specific fluorescence imaging. Applicant asserts that Luo only discloses that IR-808DP has inhibition effect of lung cancer cells. See Fig. 3a. Luo discloses that "we screened a series of IR- 808 analogs and IR-808DB, a butyl ester derivative of IR-808, was identified with simultaneous cancer targeted NIR imaging and potent anticancer activities". Appliant argues that Luo demonstrates that compound IR-808DB can simultaneously achieve tumor recognition and therapeutic effects, but does not disclose or imply that all IR-808 derivatives both have tumor recognition effects. Applicant further notes that compounds disclosed by Luo that the structure of the compounds is symmetric, whereas in the present application, the -(CH₂)n¹-L-R²² group is different the -(CH₂)n²-R²¹ group.
Applicant’s arguments have been fully considered but are not found to be persuasive. With regard to the argument that Wang is concerned with tumor therapy, rather than infrared imaging, is respectfully submitted that Wang also teaches NIR imaging, see page 2215. Regarding the argument that the structures of Wang and Luo are significantly different is noted that the phenyl of Luo and the moiety of Wang allow the compounds to be tumor targeting, as such one could have substituted one for another. With regard to the argument that one would not be able to predict that the fluorescence of the compounds of Formula I or Formula I' of the subject application can be quenched before contacting cancer cells and recovered after recognizing cancer cells, it is respectfully submitted that obviousness does not require absolute predictability, see MPEP 2144. Obviousness does not require absolute predictability, only a reasonable expectation of success, i.e., a reasonable expectation of obtaining similar properties. See, e.g.,In re O’Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988). In the instant case, each of Wang and Luo are directed to tumor targeting using a cyanine dye having overlapping structural features. With regard to the argument that Luo teaches symmetric structures, it is noted that the rejection is based on the combination of Luo with Wang, which teaches an asymmetric conjugate dye.
Claim(s) 11, 13, 14, 16 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Small (WO 20/190735) in view of Luo et al. (Biomaterials, 2013, 34, 2244-51), for reasons set forth in the previous Office Action.
Response to arguments
Applicant argues that Small discloses a NIR dye for targeting tumors. Similarly, the -(CH₂)n¹-L-R²² group of the subject application is significantly different from the corresponding group of the compound of Small. With the disclosure of Small, the skilled artisan would not be motivated to replace the R₂ groups of Small with the -(CH₂)n¹-L-R²² group of the subject application, and would not be able to predict that the fluorescence of the compounds of Formula I or Formula I' of the subject application can be quenched before contacting cancer cells and recovered after recognizing cancer cells. Applicant asserts that Luo does not disclose that IR-808DP has fluorescence imaging effect, and IR-808DP is only used as a IR-808 derivative for screening. Due to the significant difference in structure between IR-808DB and the compounds of the subject application, the skilled artisan would not obtain the compound of Formulae I and I' of the subject application, and would not be able to predict that the fluorescence of the compounds of Formula I or Formula I' of the subject application can be quenched before contacting cancer cells and recovered after recognizing cancer cells.
Applicant’s arguments have been fully considered but are not found to be persuasive. Regarding the argument that the structures of Small and Luo are significantly different is noted that the phenyl of Luo and the moiety of Wang allow the compounds to be tumor targeting, as such one could have substituted one for another. With regard to the argument wherein one would not be able to predict that the fluorescence of the compounds of Formula I or Formula I' of the subject application can be quenched before contacting cancer cells and recovered after recognizing cancer cells, it is respectfully submitted that obviousness does not require absolute predictability, see MPEP 2144. Obviousness does not require absolute predictability, only a reasonable expectation of success, i.e., a reasonable expectation of obtaining similar properties. See, e.g.,In re O’Farrell, 853 F.2d 894, 903, 7 USPQ2d 1673, 1681 (Fed. Cir. 1988). In the instant case, each of Wang and Luo are directed to tumor targeting using a cyanine dye having overlapping structural features.
Claim(s) 1, 2, 8-11, 13, 14, 16, 17, 20 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Small (WO 20/190735) in view of Luo et al. (Biomaterials, 2013, 34, 2244-51), in further view of Ho (WO 14/028057), for reasons set forth in the previous Office Action.
Response to arguments
Applicant argues that Ho discloses a cyanine dye conjugate comprising an enzymatically cleavable oligopeptide sequence and that difference in structure between the cyanine dye conjugates of Ho and the compound of the subject application is substantial.
Applicant’s arguments have been fully considered but are not found to be persuasive. It is respectfully submitted that Ho is not relied upon for the structure of the dye itself, rather for the routine use of an anionic surfactant in formulation of cyanine dyes. For example, Ho teaches that cyanine dye conjugates are suitably formulated with wetting agents, emulsifiers and lubricants, such as sodium lauryl sulfate and magnesium stearate; and that the pharmaceutical compositions may be suitable for parenteral administration comprise one or more agents of the invention in combination with one or more acceptable sterile isotonic aqueous or nonaqueous solutions. Applicant’s arguments have been fully considered but the rejections are maintained.
Conclusions
No claims are allowed at this time.
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.
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/LHS/
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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