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 .
Receipt is acknowledged of Applicant’s Amendment filed on 11/18/2025.
Claims 1, 3 have been amended.
Claims 4-5, 8-14, 34-38 have been canceled.
Claims 1-3, 6-7 are pending in the instant application.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Rejections - 35 USC § 112, 2nd paragraph
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, "Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table 'is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.' Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993)" (MPEP 2173.05(s)). In claim 1, Applicant recites “Table 1”.
The Examiner suggests copying Table 1 contents into the claim itself.
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.
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, 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over UNGER et al (US 2013/0022550) in view of OLIVEIRA et al (Peptide-Based Fibrin-Targeting Probes for Thrombus Imaging. Dalton Trans. 2017 October 31; 46(42): 14488–14508).
UNGER teaches microbubbles (see [0082]) comprised of: lipids (see [0024]), such as 10 moles of DPPE-PEG2000-fibrin binding peptide (see [0082]), which reads on microbubbles having fibrin-binding ligands attached, wherein the linker is PEG with a MW of 2000; and gas-filled with perfluoropropane (see [0082]; and [0015] at Table 1), which is the same as octafluoropropane. Additional disclosures include: formulated in aqueous environment (see [0063]; [0064) and suspensions or emulsions (see [0020]-[0023]); suspension may contain one or more bioconjugates, which comprise a targeting moiety attached to the PEG spacer on one of the lipids (see [0024]), such as fibrin binding peptide targeting moiety (see [0082]); stabilizing agents, such as trehalose (see [0062]).
UNGER does not teach using specific fibrin-binding peptides/ligands selected from Table 1, which are Tn6, Tn7 and Tn10.
OLIVEIRA teaches the prior art had known of peptide-based fibrin-targeted probes for molecular imaging of thrombosis (see title and abstract), such as Tn6, Tn7 and Tn10 (see pg. 26 at Figure 3), which has about 11-16 amino acids (see pg. 45 at Table 1).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate using specific fibrin-binding peptides selected from Table 1, which are Tn6, Tn7 and Tn10. The person of ordinary skill in the art would have been motivated to make those modifications, because these peptides would allow specific targeting of thrombosis, and reasonably would have expected success because the primary reference teaches using fibrin binding peptides to detect clot/thrombosis.
Response to Arguments
Applicant argues that that neither Unger I nor Unger 2 discloses anything in regard to fibrin binding ligands. Therefore, there would be no incentive or motivation to modify the microbubbles of Unger I with the fibrin-targeted probe of Oliveira et al.
The Examiner finds this argument unpersuasive, because UNGER specifically teaches “fibrin binding peptide” (see [0082]), wherein OLIVEIRA specifically teaches “peptide-based fibrin-targeting probes” (see title).
Applicant argues that Unger I does not disclose that the aqueous emulsion or suspension comprises trehalose or D (+) trehalose dihydrate as a stabilizing agent.
The Examiner finds this argument unpersuasive, because UNGER specifically teaches using trehalose as a stabilizing agent (see [0062]).
Applicant argues that there is a lack of reasonable expectation of success for such modification or combination since undue experimentation would be needed to make the required modification and combination successful.
The Examiner finds this argument unpersuasive, because 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 incorporate using specific fibrin-binding peptides selected from Table 1, which are Tn6, Tn7 and Tn10. The person of ordinary skill in the art would have been motivated to make those modifications, because these peptides would allow specific targeting of thrombosis, and reasonably would have expected success because the primary reference teaches using fibrin binding peptides to detect clot/thrombosis.
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.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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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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/JAKE M VU/Primary Examiner, Art Unit 1618