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 .
Amendments
Applicants’ amendments to the claims filed 12/2/2025 have been entered. Any objection\rejections from the previous office action filed 9/3/2025 not addressed below has been withdrawn.
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) 1,3-6,11,15,28 and 33-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aubin-Walker et al. (US 2019/0241956 A1) in view of Kjaer et al. (WO 2016/041558 A1), cited by applicants, for the reasons set forth in the previous action filed 9/3/2025.
Regarding new claims 33-36, these claims recite features from the previous rejected claims and are obvious for the reasons set forth in the previous action. Polysorbate-20 is listed at [0005].
Claim(s) 1,3-6,11,14-15,28 and 33-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aubin-Walker et al. (US 2019/0241956 A1) in view of Kjaer et al. (WO 2016/041558 A1), cited by applicants, in view of Pyne et al. “Solute Crystallization in Mannitol–Glycine Systems-Implications on Protein Stabilization in Freeze-Dried Formulations, JOURNAL OF PHARMACEUTICAL SCIENCES, VOL. 92, NO. 11, NOVEMBER 2003, for the reasons set forth in the previous action filed 9/3/2025.
Regarding new claims 33-38, these claims recite features from the previous rejected claims and are obvious for the reasons set forth in the previous action. Regarding new claim 38, sucrose is taught at [0050] of Aubin-Walker, while mannitol is provided as disclosed in the previous action by Pyne.
Claim(s) 1,3-6,11,14-15,28 and 33-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jochheim et al. (WO 2015/042202) in view of Kjaer et al. (WO 2016/041558 A1), for the reasons set forth in the previous action filed 9/3/2025.
Regarding new claims 33-38, these claims recite features from the previous rejected claims and are obvious for the reasons set forth in the previous action. Mannitol and sucrose and combinations are taught at [0203] and polysorbate-20 at [0216].
Response to Arguments
Applicant's arguments filed 12/2/2025 have been fully considered but they are not persuasive.
Applicants assert their compounds provide markedly improved stability of ICG-Glu-Glu-AE105 for more than a year at RT and the references do not teach how to stabilize to such a magnitude.
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., stability over time) 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 since the composition of the combined teachings is within the claimed scope any property discovered by applicants is merely the natural result from the combination.
Applicants state Jockheim teaches away from the invention as it exhibits lower stability. Applicants further assert that Jockheims compounds contain chlorotoxin and are toxic and not suitable in combination with ICG-Glu-Glu-AE105 which is non-toxic.
These assertions are unsupported and as such cannot be considered persuasive. There is no comparison make to the prior art in terms of data and the allegations are merely unsupported opinion. There is no data that compares the stability nor the effectiveness of the composition.
Applicants next pick on the Aubin-Walker and Jockhem references for teaching compounds with longer lengths of peptide sequences then ICG-Glu-Glu-AE105 which would affect solubility.
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 neither reference teaches ICG-Glu-Glu-AE105 which is the reason they were combined with Kjaer which teaches the same compound claimed. When the fluorophore targeting conjugates of the primary references are substituted with ICG-Glu-Glu-AE105 any properties discovered by applicants will naturally be the same since the compositions are the same.
Applicants assert the recited pH level being physiological pH is not covered by the primary references.
The relevance of this assertion is unclear since the examiner stated in the last action that the pH disclosed in each is within the claimed pH range of a physiological or substantially physiological pH.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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