DETAILED ACTION
This action is pursuant to the claims filed on 09/08/2025. Currently claims 1-6, 10, 12,15, 18-29 are pending with claims 18-29 withdrawn and claims 7-9, 11, 13-14, 16-17, 30 canceled. Below follows a complete action on the merits of claims 1-6, 10, 12, 15.
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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Foreign Priority date of 01/23/2019 acknowledged by examiner.
Continued Examination Under 37 CFR 1.114
Receipt is acknowledged of a request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e) and a submission, filed on 09/08/2025.
Response to Amendment
The examiner acknowledges that no new amendments have been made in accordance with the request for continued examination. The following action is the rejection and examiner response to the arguments submitted with the request for continued examination.
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.
Claim(s) 1-6, 12, 15 is/are rejected under 35 U.S.C. 103 as being anticipated by Pham et al (US Patent No 2011/0077644) in view of Azure (US Patent No 20080071264).
Regarding claim 1, Pham teaches a tissue ablation device (tissue treatment device 100, para [0041]), the device comprising: a sheath comprising a distal end that is position-able at an ablation site in the tissue (delivery cannula 102 can be introduced within a patient, para [0041]), a proximal end and a lumen extending therebetween (cannula lumen 114, para [0042]); one or more electrodes that are advanceable and retractable through the lumen, wherein a distal portion of the one or more electrodes is deployable into a tissue ablating configuration from the distal end of the sheath upon advancement, and the one or more electrodes are removable from the lumen via the proximal end of the sheath upon retraction (the distal handle member 144 can be moved relative to the proximal handle member 146 to alternately deploy the proximal and distal electrode arrays 138, 140 out from the probe shaft 136 and retract the proximal and distal electrode arrays 138, 140 within the probe shaft 136, para [0044], wherein the hollow space of the probe shaft 136 is found within the lumen 114, see also fig 1), whereupon the lumen becomes vacated (central lumen 114 sized so that shaft 136 may be slid in and out of the lumen, para [0055]) wherein the sheath is configured for a surgical material to traverse the vacated lumen for delivery from the distal end of the sheath into the tissue (cannula lumen 114 terminates at an axial opening 118 located at the distal tip of the cannula shaft 108. As will be described in further detail below, the axial opening 118 serves as a port out which respective operative elements of the biopsy stylet 104 or any pharmaceutical agents are delivered to a targeted tissue region, para [0059]).
Pham does not teach wherein the tissue ablating configuration of the or each of the one or more electrodes is independently circular or helical in shape, nor does it Pham explicitly teach the distal end of the sheath comprises crenulations for guiding an initial direction of deployment of the one or more electrodes.
However, the analogous deployable RF ablation system disclosed by Azure does teach the tissue ablating configuration where each of the one or more electrodes is independently circular or helical in shape (See from Azure figs 12A-12C, which show that the deployable electrodes may be circular or coiled in shape, [0060]). Azure also teaches the distal end of the sheath comprises crenulations for guiding an initial direction of deployment of the one or more electrodes (See from Azure figs 15A-15C, wherein the distal tip contains individual microcatheters 330 which naturally create notches or crenulations on the delivery member 330 used for guiding and deploying the treatment electrodes, [0064]).
Therefore, it would have been obvious to one skilled in the art prior to the effective filing date to combine the tissue ablation system taught by Pham to contain the specific helical electrode structure and electrode crenulations disclosed by Azure in order to provide the treatment system with greater elasticity and working area for reaching harder treatment regions as well as providing the system with a more efficient electrode guiding configuration as taught by Azure, [0064].
Regarding claim 2, Pham teaches the device of claim 1, further comprising a dispenser which is operable to dispense the surgical material (wherein the surgical material is the pharmaceutical agent 90, para [0082]) into the vacated lumen (After the probe 106 is removed from the cannula 102, the proximal portion 76a and the distal portion 76b of the outer tube 76b are selectively translated to deliver the pharmaceutical agent 90, see para [0082] for how the outer tube further 76a and 76b act as the dispenser).
Regarding claim 3, Pham teaches the device of claim 2, wherein the dispenser is attachable to the proximal end of the sheath (cannula 102 is then manipulated from the proximal end 109, such that the distal end 111 is positioned at the next tissue region where the pharmaceutical agent 90 is to be delivered, para [0084]).
Regarding claim 4, Pham teaches the device of claim 1, wherein the one or more electrodes are configured to have a polarity during ablation opposite that of a grounding pad positioned on the body of a patient, whereby ablation occurs between the electrode(s) and the grounding pad (the proximal and distal electrode arrays 138, 140 are in a monopolar arrangement where the current passes from the proximal and distal electrode arrays 138, 140, which are configured to concentrate the energy flux in order to have an injurious effect on the surrounding tissue, to a dispersive electrode located remotely from the electrode arrays 138, 140. The dispersive electrode may be attached externally to the patient, e.g., using a contact pad, para [0054]).
Regarding claim 5, Pham teaches the device of claim 1, wherein the one or more electrodes are configured to have a polarity during ablation opposite that of an electrically conductive portion of the sheath, whereby ablation occurs between the electrode(s) and the electrically conductive portion of the sheath (the proximal and distal electrode arrays 138, 140 are in a bipolar arrangement. Thus, when RF energy is conveyed to the ablation probe 112, the RF current passes between the arrays 138, 140, and the probe 112, para [0053], whereby the ablation probe is an extension of the sheath).
Regarding claim 6, Pham teaches the device of claim 1, wherein the one or more electrodes comprise a plurality of electrodes configured to have opposite polarities during ablation (the proximal and distal electrode arrays 138, 140 are in a bipolar arrangement. Thus, when RF energy is conveyed to the ablation probe 12, the RF current passes between the arrays 138, 140, para [0053]).
Regarding claim 12, Pham teaches the device of claim 1, wherein the sheath is configured for percutaneous insertion into the tissue or for endoscopic insertion into the tissue (To facilitate percutaneous introduction of the delivery cannula 102 through tissue, the optional obturator 107 takes the form of a conventional trocar 107, para [0057]).
Regarding claim 15, Pham teaches the device of claim 1, further comprising a deployment handle which is operable to advance and retract the one or more electrodes through the lumen (distal handle member 144 can be moved relative to the proximal handle member 146 to alternately deploy the proximal and distal electrode arrays 138, 140, para [0044]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pham et al (US Patent No 2011/0077644) in view of Azure (US Patent No 20080071264) further in view of Eladoumikdachi (US Patent No 2018/0036062)
Regarding claim 10, Pham and Azure teach the device of claim 1.
Pham and Azure do not teach wherein the one or more electrodes are configured for single use.
However, single use or disposable electrodes are well known in the art as it is taught by the analogous electrosurgical device of Eladoumikdachi in which the active electrodes are provided as sterile, disposable units for single use, para [0020].
Therefore, it would have been obvious for one skilled in the art to combine the structure of the tissue ablation device disclosed by the previous combination to contain single use or disposable electrodes taught by Eladoumikdachi in order to maintain a healthy and sterile surgical environment (para [0020]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 regarding the prior art of record of Shuman and Deckman and how they were not an obvious combination to make with the primary reference of Pham 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.
Specifically, with regards to the arguments of claim 1 that the prior art of record of Shuman or Deckman are not analogous pieces of prior art, and still do not teach the helical shaped electrodes nor the crenulations for electrode guidance have been considered. However, due to the request for continued examination and the arguments presented this has necessitated further search and consideration from the examiner in which it has been found that the new prior art of record rejection of Pham in view of Azure teach the tissue ablating configuration where each of the one or more electrodes is independently circular or helical in shape (See from Azure figs 12A-12C, which show that the deployable electrodes may be circular or coiled in shape, [0060]). Azure also teaches the distal end of the sheath comprises crenulations for guiding an initial direction of deployment of the one or more electrodes (See from Azure figs 15A-15C, wherein the distal tip contains individual microcatheters 330 which naturally create notches or crenulations on the delivery member 330 used for guiding and deploying the treatment electrodes, [0064]). Therefore, the new prior art of record of Azure teaches all possible deficiencies which may have been found in the previous office action, and the claim 1 remains rejected under the new prior art of record rejection of Pham in view of Azure as seen in the present office action.
As no further remarks or arguments have been made regarding any other claims, they too remain rejected under the new prior art of record rejection as per their dependency on the independent rejected claim 1.
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/KYLE M. BROWN/Examiner, Art Unit 3794