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 .
Election/Restrictions
Applicant’s election without traverse of Group IV (claims 20-24) in the reply filed on July 21st, 2026 is acknowledged.
Response to Amendment
The amendment filed July 21st, 2024 has been entered. Claims 25-32 are new. Claims 1-19 are canceled. Claims 20-32 remain pending.
Claim Objections
Claim 21 is objected to because of the following informalities: “one or more of the openings” should be – one or more of the plurality of openings—; as introduced in claim 20. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
Claims 20-21, 25, & 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mahapatra et al. (US 20100114093 A1), hereinafter “Mahapatra”.
Regarding claim 20, Mahapatra discloses a vacuum drain device ([0059]) comprising: a tube ([0057]; Figures 1 & 2C—element 2) comprising a linear portion ([0057] & [0062]; Figures 1 & 2—element “PS”; the examiner is considering the linear portion to be the proximal segment “PS”) and a curved portion extending from a distal end of the linear portion ([0057] & [0062]; Figures 1 & 2—elements 3, 4, “MS”, & “DS”; the examiner is considering the curved portion to be the medial segment “MS” and distal segment “DS” which have curvatures 3 & 4)), the tube defining a lumen ([0063]; Figures 1 & 3A—element 2; the lumen being the lumen of tube 2), the curved portion defining a plurality of openings through a wall of the tube and into the lumen ([0063]; Figure 3A—elements 14, 15, 22, 23, 24, & 25); and a plurality of electrodes attached to the curved portion ([0063]; Figure 3A—elements 16, 18, 20, & 21).
Regarding claim 21, Mahapatra discloses all of the limitations of claim 20, as described above.
Mahapatra further discloses wherein one or more of the openings are disposed between adjacent electrodes of the plurality of electrodes ([0063]; Figure 3A; Figure 3A portrays openings 22, 23, 24 disposed between adjacent electrodes 16, 18, 20, & 21).
Regarding claim 25, Mahapatra discloses all of the limitations of claim 20, as described above.
Mahapatra further discloses wherein the electrodes of the plurality of electrodes are independently wired and independently controllable ([0074]; Figure 8—elements 36).
Regarding claim 32, Mahapatra discloses all of the limitations of claim 20, as described above.
Mahapatra further discloses wherein the plurality of electrodes are configured to deliver at least one of electroporation energy or ablation energy ([0063]).
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.
Claims 22-24 & 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Mahapatra in view of Schuler et al. (US 20210177509 A1), hereinafter “Schuler”.
Regarding claims 22-24 & 29-31, Mahapatra discloses all of the limitations of claim 20, as described above.
Mahapatra does not disclose a wire mesh surrounding at least a portion of the curved portion (claim 22); a shaft including a distal end portion to which the wire mesh is attached (claim 23); wherein the shaft defines a lumen configured to slidably receive the tube such that the curved portion can be disposed within an interior space defined by the wire mesh (claim 24); wherein the wire mesh comprises Nitinol or stainless steel (claim 29); wherein the wire mesh is configured to act as an electrode in conjunction with the plurality of electrodes (claim 30); wherein the wire mesh is manually expandable and retractable to a low-profile configuration (claim 31).
Schuler teaches an ablation device comprising a tube and a portion comprising a plurality of electrodes ([0043], [0045], [0046], [0198], [0201]; Figures 17A & 17B—elements 1602 & 1604; the treatment element 1604 may include an array of electrodes); a wire mesh surrounding at least a portion of the portion (claim 22) ([0169], [0170], [0206], [0208], & [0209]; Figure 16C, 17A, & 17B—element 1501); a shaft including a distal end portion to which the wire mesh is attached (claim 23) ([0170], [0206], [0208], & [0209]; Figures 16C, 17A, & 17B—element 1508); wherein the shaft defines a lumen configured to slidably receive the tube such that the portion can be disposed within an interior space defined by the wire mesh (claim 24) ([0170], [0206], [0208], & [0209]; Figures 16C, 17A, & 17B—element 1509); wherein the wire mesh comprises Nitinol or stainless steel (claim 29) ([0173]); wherein the wire mesh is configured to act as an electrode in conjunction with the plurality of electrodes (claim 30) ([0170] & [0174]; Figure 16C—element 1504); wherein the wire mesh is manually expandable and retractable to a low-profile configuration (claim 31) ([0175], [0178], & [0207]; the mesh 1502 may be constructed to expand actively such that a user can manipulate a lever to actively expand or collapse the wires of the mesh).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the ablation catheter, as disclosed by Mahapatra, to include a wire mesh surrounding at least a portion of the distal portion of the ablation catheter, as taught by Schuler, as both references and the claimed invention are directed toward electrosurgical devices for ablating tissue. As disclosed by Schuler, the ablation catheter can be used in conjunction with a mapping catheter comprising an expandable mesh structure, such that the ablation catheter can be inserted into the interior of the mesh mapping structure, this permits mapping to be accomplished while the delivery of therapy originates with the ablation catheter ([0209]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the ablation catheter, as disclosed by Mahapatra, to include a wire mesh surrounding at least a portion of the distal portion of the ablation catheter, as taught by Schuler, as such a modification would allow for simultaneous mapping and ablating to be performed.
Claims 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Mahapatra in view of Flanagan (US 20200297414 A1), hereinafter “Flanagan”.
Regarding claims 26-28, Mahapatra discloses all of the limitations of claim 20, as described above.
Mahapatra does not disclose a light source comprising a low energy laser or one or more light emitting diodes (claim 26); wherein the light source is configured to emit blue light or violet light (claim 27); wherein the light source is configured to emit the blue light at a wavelength between four hundred five nanometers and four hundred seventy nanometers (claim 28).
Flanagan teaches an ablation catheter ([0055]; Figure 1—element 10) comprising a light source comprising a low energy laser or one or more light emitting diodes (claim 26) ([0059] & [0069]; Figures 1 & 2—element 56/66); wherein the light source is configured to emit blue light or violet light (claim 27); wherein the light source is configured to emit the blue light at a wavelength between four hundred five nanometers and four hundred seventy nanometers (claim 28) ([0059], [0069], [0081]; Figure 2—elements 56/66; the catheter includes a light source 66, such as an LED, that is configured to transmit a first light beam 70 via an optical fiber 56; the first light beam 70 can be an ultraviolet light or a blue light with wavelengths ranging from approximately 380 to 500 nm).
A person of ordinary skill in the art, before the effective filing date of the claimed invention, would have been motivated to modify the ablation catheter, as disclosed by Mahapatra, to include a light source configured to emit a blue light or violet light, as taught by Flanagan, as both references and the claimed invention are directed toward electrosurgical devices for ablating tissue. As disclosed by Flanagan, the ablation catheter may include a light source and optical fibers for assessing the degree of blood perfusion in the target tissue to be ablated which can provide useful information to the clinician during an ablation procedure such as indicating when ablation energy should be applied and assessing the formation of lesions ([0059] & [0073]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the ablation catheter, as disclosed by Mahapatra, to include a light source configured to emit a blue light or violet light, as taught by Flanagan, as such a modification would allow for the ablation catheter system to assess the degree of blood perfusion in the target tissue to be ablated which can provide useful information to the clinician during an ablation procedure such as indicating when ablation energy should be applied and assessing the formation of lesions.
Conclusion
Accordingly, claims 20-32 are rejected.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Tu et al. (US 20050240249 A1) discloses a vacuum drain device comprising: a tube comprising a linear portion ([0109]; Figure 17—element 111) and a curved portion extending from a distal end of the linear portion ([0109]; Figure 17—element 112), the tube defining a lumen ([0109]; Figure 17—element 118), the curved portion defining a plurality of openings through a wall of the tube and into the lumen ([0109]; Figure 17—elements 116); and a plurality of electrodes attached to the curved portion ([0078]; Figure 17—elements 114).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARINA D TEMPLETON whose telephone number is (571)272-7683. The examiner can normally be reached M-F 8:00am to 5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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