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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant’s amendment to include the closed distal end has required further consideration especially with respect to the claim
Claim Rejections - 35 USC § 102
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.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fischell et al (US 2014/0121644).
Regarding amended claim 1, Fischell et al which expressly discloses a medical system including a sheath with a closed distal end (Fig 2, 109), a tracked catheter with ultrasound transmissive properties (0060), a port configured for fluid reception, and an ultrasound energy application via ultrasound applicator. Finally, Fischell et al discloses that IVUS, OCT, and angiography (among other modalities, 0031, 0060) may be used for localization beyond the tube, IVUS including an imaging ultrasound transducer (0031, 0060).
Regarding claims 2-3 and 11 Fischell et al does disclose multiple lumens, and discloses delivery catheter (140, Fig 8) for delivering the catheter therein (Fig 8). Additionally, needle device(s) configured to be placed into at least one of the other lumen(s) is/are disclosed (Claim 1, 0007-0008) as well as flexible guide tubes/lumens (0016, 0042, 0048, 0165, 0173, 0187, 0249 (including teaching making the guide tubes as flexible as desired for application).
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, 6-7, 9-12, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al (US 2014/0121644) in view of Burdette et al (US 2015/02009551).
As disclosed above, and regarding amended claim 1 and 11, Fischell et al which expressly discloses a medical system including a sheath with a closed distal end (Fig 2, 109), a tracked catheter with ultrasound transmissive properties (0060), a port configured for fluid reception, and an ultrasound energy application via ultrasound applicator. Finally, Fischell et al discloses that IVUS, OCT, and angiography (among other modalities, 0031, 0060) may be used for localization beyond the tube, IVUS including an imaging ultrasound transducer (0031, 0060).
Regarding claims 2-3 and 11 Fischell et al does disclose multiple lumens, and discloses delivery catheter (140, Fig 8) for delivering the catheter therein (Fig 8). Additionally, needle device(s) configured to be placed into at least one of the other lumen(s) is/are disclosed (Claim 1, 0007-0008) as well as flexible guide tubes/lumens (0016, 0042, 0048, 0165, 0173, 0187, 0249 (including teaching making the guide tubes as flexible as desired for application).
Regarding claims 9-10, 12, and 15, Fischell et al fails to disclose ancillary devices like an ultrasound needle which expressly includes a piezoelectric transducer coupled thereto or utilizing multiple transducers on the distal portion of the catheter.
Attention is hereby directed to the teaching reference to Burdette et al which expressly teaches multi-lumen implementation (0005, 0072-0073), an ultrasonic needle (0045, 0048, 0107, 0110), as well as multiple transducer elements in the catheter (0054, 0072-0073) and ultrasound transmissive window in the sheath (0075). It would have been obvious to one of ordinary skill in the art at the time of the invention to have utilized the teachings of Burdette with those of Fischell et al to provide additional flexibility during imaging and biopsy with the prostate as the target (Burdette, 0035, 0041, 0045).
Regarding claims 6-7, Fischell et al further discloses and teaches the tapering of the lumen at a distal end (Fig 15), the inclusion of Luer fittings for connecting the injection needle device (0141, 0209), and electrical connection to apply RF energy (0054-0055).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al in view of Burdette et al (US 2015/02009551) as applied to claim 3 above, and in further view of University of Korea patent (KR 102180645, hereafter Univ of Korea ‘645). Fischell et al discloses what is listed above, but fails to disclose the IRE with a needle instead of electrode assembly (0036, Fig 1). Attention is hereby directed to the teaching reference to Univ of Korea ‘645 which expressly discloses and teaches the use of a needle (0023-0027, Fig 3) for the Irreversible electroporation along with echo markings (0057-0059). It would have been obvious to one of ordinary skill in the art at the time of the invention to have utilized the teachings of Univ of Korea ‘645 for IRE treatment with those of Fischell in view of Burdette et al in order to facilitate a modified treatment form the electrode assembly (0054-0058, abs, Fischell).
Claim(s) 8 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fischell et al in view of Greenwood et al (US 2022/0202397). While Fischell et al discloses all that is listed above, they fail to disclose the light source with needle element, including distal catheter light sources, though optical imaging is specifically recited (0060, OCT). The OCT imaging is simply not recited with enough specificity to denote the light source. Attention is hereby directed to the teaching reference to Greenwood et al which expressly discloses the inclusion of light based imaging and (Fig 3, 310, distal end) illumination during biopsy interrogation. It would have been obvious to one of ordinary skill in the art at the time of the invention to have utilized the teachings of Greenwood et al with those of Fischell et al to enable sensing and EM tracking at the distal end of the endoscopic biopsy device (0091-0092, Greenwood et al).
Fischell et al fails to disclose a console attached to the electrical connector for energy delivery, but attention is briefly directed to the reference to Greenwood et al which expressly discloses a separate console element for application of the RF energy/power (0087, including RF energy as with Fischell, 0122) as well as monitoring suite (0033). It would have been obvious to one of ordinary skill in the art at the time of the invention to have utilized electrical connections like those of Greenwood et al with the controller and monitoring thereof with the system of Fischell et al to enable electrical supply of the device from a console (0081-0086 for catheter elements of Greenwood, controlled by (0074, 0078-0079, 0087-0090, 0167)).
Response to Arguments
Applicant’s arguments with respect to the claim(s)have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 JOEL M. LAMPRECHT whose telephone number is (571)272-3250. The examiner can normally be reached Mon - Fri 9:00-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOEL LAMPRECHT/Primary Examiner, Art Unit 3798
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