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 6/6/2025, in reply to the Office Action mailed 2/13/2025, is acknowledged and has been entered. Claim 25 has been amended. Claims 1, 4, 5, 10-19, 21-23 and 25-28 are pending and are examined herein on the merits for patentability.
Response to Arguments
Any rejection not reiterated herein has been withdrawn as being overcome by claim amendment.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, 10-16, 21, 25 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Shum et al. (J. Endourol. Case Rep., 2016, 2(1), p. 189-197) in view of Carroll (Fluorescence imaging vision system in robotic assisted surgery receives expanded clearance, 2013) in further view of Butte (WO 2019/191497), for reasons set forth in the previous Office Action.
Claim(s) 1, 10-16, 21 and 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Shum et al. (J. Endourol. Case Rep., 2016, 2(1), p. 189-197) in view of Carroll (Fluorescence imaging vision system in robotic assisted surgery receives expanded clearance, 2013) and Butte (WO 2019/191497), in further view of Kularatne et al. (US 2017/0285040), for reasons set forth in the previous Office Action.
Claim(s) 1, 10-16, 21-23, 25 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Shum et al. (J. Endourol. Case Rep., 2016, 2(1), p. 189-197) in view of Carroll (Fluorescence imaging vision system in robotic assisted surgery receives expanded clearance, 2013) in further view of Butte (WO 2019/191497) and Cade (US 2017/0151357), for reasons set forth in the previous Office Action.
Claim(s) 1, 4, 5, 10-19, 21-23, 25 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Shum et al. (J. Endourol. Case Rep., 2016, 2(1), p. 189-197) in view of Carroll (Fluorescence imaging vision system in robotic assisted surgery receives expanded clearance, 2013) in further view of Butte (WO 2019/191497) and Predina et al. (Journal of Thoracic Oncology, 22018, 13 (7), p. 1028-1036), for reasons set forth in the previous Office Action.
Response to arguments
Applicant argues that Shum does not teach or suggest at least the features of “wherein the final space or distance is 1-2 cm from the end of the biological tissue or intervention site” and “wherein the method further comprises monitoring responses to surgical procedures, chemotherapy, immunotherapy, and/or radiotherapy in the human or animal subject” as required by Claim 1. Applicant asserts that the Patent Office has misconstrued the terms of the claim. The Patent Office seems to assert that [0142]-[0143] of Butte teach this feature, which refers to the working distance from an objective lens of the optical system to the tissue being imaged. This is not the distance recited in Claim 1. Applicant asserts that claim 1 recites the tissue depth distance - not the working distance described in Butte. As disclosed in [0059] of the Present Application the use of the compound helps an operator (e.g., surgeon) navigate the final 1-2 cm through the biological tissue.
Applicant’s arguments have been fully considered but are not found to be persuasive. With regard to the arguments directed to the tissue depth, it is respectfully submitted that the claim does not recite the term tissue depth. Rather the claim recites
wherein the final space or distance is 1-2 cm from the end of the biological tissue or intervention site. Absent evidence to the contrary it is interpreted that the final site consistent with the site of the probe and the site of the tissue is the site of the end of the biological tissue or intervention site. Accordingly the distance between the optical probe and the tissue, from among distances known in the art to be suitable in order to determine the desired fluorescence imaging is interpreted to encompass the claim limitations.
Applicant further argues that the Office Action is silent as to the term “wherein the
method further comprises monitoring responses to surgical procedures, chemotherapy, immunotherapy, and/or radiotherapy in the human or animal subject.” Applicant asserts that as explained in [0075] of the Present Application, “the compounds disclosed herein can also be administered to a subject to perform optical imaging of a previous surgical or intervention site to monitor tumor progression or regression or response to treatment or surgery.” Shum is silent as to monitoring a previous surgical or intervention site. None of the references Carroll, Butte, Kularatne, Cade, nor Predina, alone or together, cure the deficiencies of Shum.
With regard to the argument that the Office Action is silent as to the term “wherein the method further comprises monitoring responses to surgical procedures, chemotherapy, immunotherapy, and/or radiotherapy in the human or animal subject,” it is respectfully submitted that Shum’s recitation of identification of any residual disease immediately after excision is at least consistent with monitoring responses to surgical procedures, as claimed. Carroll, Butte, Kularatne, Cade, or Predina are provided to address limitaitons of the dependent claims.
Applicant further argues that although the Patent Office asserts on page 8 of the Office Action that “[i]t would have been obvious...,” the Patent Office fails to provide a reasoned explanation as to why it would have been obvious.
With regard to the assertion that Patent Office fails to provide a reasoned explanation as to why it would have been obvious, it is respectfully submitted that the previous Office Action states that it would have been obvious that the imaging system taught by Shum comprises a flexible probe upon performing an interventional procedure… because Shum teaches that a da Vinci® Fluorescence Imaging Vision System (Intuitive Surgical, inc., Sunnyvale, CA) is used to identify tumor margins, and further notes that Carroll teaches that a da Vinci Surgical System includes an HD 3D vision system, which consists of a 3D endoscope - a flexible tube with a camera and light at the tip - and image processing equipment that provides images of the patient’s anatomy. Accordingly, the Carrroll reference is provided to clarify that the imaging system in Shum incorporates a flexible tube. A reasoned explanation of selection of imaging distance is further set forth. Applicant’s arguments have been fully considered but the rejections are maintained.
Conclusion
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