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 .
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.
Claim Objections
Claim 1 objected to because of the following informalities:
“and comprising” in line 4 should be written “comprising”
Appropriate correction is required.
Claim 4 objected to because of the following informalities:
“plurality pairs” in line 1 should be written “plurality of pairs”
Appropriate correction is required.
Claim 20 objected to because of the following informalities:
“The end effector of any claim 1” in line 1 should be written “The end effector of claim 1”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-20 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.
Claim 1 recites the limitation “pulse filed ablation” in line 6. It is unclear whether this limitation should be interpreted as “pulse field ablation” or some other interpretation.
Claims 2-10 are rejected as being dependent upon a rejected base claim.
Claim 11 recites the limitation “pulse filed ablation” in line 3. It is unclear whether this limitation should be interpreted as “pulse field ablation” or some other interpretation.
Claims 12-20 are rejected as being dependent upon a rejected base claim.
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.
Claim(s) 1-14, 16, and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ebrahimi et al., (US 20230200895; hereinafter Ebrahimi).
Regarding claim 1, Ebrahimi (Figures 1-6) discloses an end effector (400) of a medical probe (100), the end effector (400) comprising: a planar body comprising a first side (one flat side of element 400) and a second side (opposite flat side of element 400) opposite the first side and extending along a longitudinal axis ([0055]-[0060]); and a plurality of ablation electrodes ([0066]-[0067]: groups of electrodes 472, on either side of element 400, which may be configured to activate simultaneously to form larger ablation electrodes A-D, as shown in annotated Figure 6 below) and comprising a first ablation electrode (electrode B shown in annotated Figure 6 below, located on the first flat side of element 400) disposed on the first side of the planar body (400) and a second ablation electrode (the electrode located on the second flat side of element 400 corresponding/opposite to electrode C on the first flat side of element 400 shown in annotated Figure 6 below), the end effector (400) being configured to provide bipolar pulse filed ablation electrical signals between the first ablation electrode (electrode B on first side) and the second ablation electrode (electrode on second side corresponding/opposite to electrode C), ([0003], [0023], [0026]-[0027], [0067]), the first ablation electrode (electrode B on first side) and the second ablation electrode (electrode on second side corresponding/opposite to electrode C) each having a respective length of at least half of a total length of the end effector (400) as measured from a distal end of the end effector (400) to a distal end of a shaft (122) of the medical probe (100) such that the respective length of the first ablation electrode (electrode B on first side) and the second ablation electrode (electrode on second side corresponding/opposite to electrode C) define a distal portion of the end effector (400), ([0056]-[0060]: the length of electrodes A/D extends at least half a total length of the end effector as shown in annotated Figure 6 below).
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Annotated Figure 6 from the Ebrahimi reference
Regarding claim 2, Ebrahimi (Figures 1-6) further discloses at least one diagnostic electrode (electrodes 462 in segments 1/2, shown in annotated Figure 6 above, which may be configured as diagnostic electrodes) disposed on at least one of the first side (first flat side) or second side (second opposite flat side) of the planar body (400), the at least one diagnostic electrode (diagnostic electrodes in segments 1/2 shown in annotated Figure 6 above) being electrically isolated from the plurality of ablation electrodes (A-D) and configured to receive electrical signals from tissue ([0060], [0066]).
Regarding claim 3, Ebrahimi (Figures 1-6) further discloses the at least one diagnostic electrode (electrodes 462 in segments 1/2, shown in annotated Figure 6 above, which may be configured as diagnostic electrodes) comprises plural pairs of diagnostic electrodes (electrodes 462 which may be configured as diagnostic electrodes) with each pair being disposed diametrically along an axis orthogonal to the longitudinal axis with respect to each other on respective first and second (flat) sides ([0040], [0060], [0066]: electrodes may be arranged in pairs along longitudinally extending portions 346).
Regarding claim 4, Ebrahimi (Figures 1-6) further discloses a plurality pairs of tissue contact electrodes (tissue contact electrode pairs X/Y, as shown in annotated Figure 6 above, on each flat side of element 400 providing pairs of electrodes X/Y on each side) spaced apart orthogonally along the longitudinal axis, each pair of the plurality of pairs of tissue contact electrodes (X/Y) being disposed on at least one of the first side or the second side proximate the distal portion of the end effector ([0060], [0066]).
Regarding claim 5, Ebrahimi (Figures 1-6) further discloses a plurality of first ablation electrodes (electrodes A-D on one flat side of element 400 shown in annotated Figure 6 above) comprising four individual first ablation electrodes (A-D), said first ablation electrode (B) being one of the four individual first ablation electrodes (A-D), in which each of the four first ablation electrodes (A-D) can be connected to the other three ablation electrodes to form one or more combined first ablation electrodes with a greater electrode area than any individual first ablation electrode (A-D); and a plurality of second ablation electrodes (electrodes A-D on the other flat side of element 400 shown in annotated Figure 6 above) comprising four individual second ablation electrodes (A-D), said second ablation electrode (C) being one of the four individual second ablation electrodes (A-D), in which each of the four second ablation electrode (A-D) can be connected to any of the other three second ablation electrodes to form a combined second ablation electrode with a greater electrode area than any individual second ablation electrode (A-D), ([0055]-[0060], [0066]).
Regarding claim 6, Ebrahimi (Figures 1-6) further discloses the first ablation electrode (electrode B shown in annotated Figure 6 above) comprising a plurality of longitudinally elongated segments (segments 446 carrying diagnostic electrode segments 1/2 shown in shown in annotated Figure 6 above) positioned left or right of each other, each segment (segment 446 carrying segments 1/2) of the plurality of longitudinally extending segments defining a width and a length, wherein a diagnostic electrode (electrode 462 which may be configured as a diagnostic electrode) is positioned entirely within the width and entirely within the length of a respective longitudinally extending segment (segment 446 carrying segments 1/2) corresponding to the first ablation electrode (A), ([0060], [0066]).
Regarding claim 7, Ebrahimi (Figures 1-6) further discloses wherein each ablation electrode of the plurality of ablation electrodes (electrodes A-D shown in annotated Figure 6 above) comprises a serpentine shape (shown in Figure 6), wherein the serpentine shape of the first ablation electrode (electrode B shown in annotated Figure 6 above) bends around at least three of four sides of a diagnostic electrode ([0060], [0066]: the serpentine shape of electrode B bends at least 3 times around 3 curves of diagnostic electrode segment 1).
Regarding claim 8, Ebrahimi (Figures 1-6) further discloses the plurality of ablation electrodes (electrodes A-D shown in annotated Figure 6 above) each being flush with the planar body (flat body of element 400) to provide a first planar surface (first surface 440) to the end effector (400) corresponding to the first side of the planar body and a second planar surface (second surface 440) to the end effector (400) corresponding to the second side of the planar body ([0055]-[0060], [0066]).
Regarding claim 9, Ebrahimi (Figures 1-6) further discloses the planar body (flat body of element 400) being symmetric about a centerline bisecting the planar body along the longitudinal axis, the planar body having a left half and a right half as viewed on the first side, the left half being left of the centerline, the right half being right of the centerline, and the first ablation electrode (electrode A shown in annotated Figure 6 above) defining a first electrode region disposed entirely in the left half ([0055]-[0060], [0066]).
Regarding claim 10, Ebrahimi (Figures 1-6) further discloses a pair of tissue contact electrodes (contact electrode pair X-Y shown in annotated Figure 6 above) disposed on the first side of the planar body (body of element 400) across the centerline; and a reference electrode (reference electrode X shown in annotated Figure 6 above located on the other flat side of element 400 across the centerline from the contact electrode pair X-Y above) disposed on the first side of the planar body across the centerline ([0055]-[0060], [0066]).
Regarding claim 11, Ebrahimi (Figures 1-6) further discloses the plurality of ablation electrodes further comprising a third ablation electrode (electrode A shown in annotated Figure 6 above) and a fourth ablation electrode (electrode D shown in annotated Figure 6 above), the end effector (400) being configured to provide bipolar pulse filed ablation electrical signals between the third ablation electrode (electrode A) and the fourth ablation electrode (electrode D), ([0055]-[0060], [0066]).
Regarding claim 12, Ebrahimi (Figures 1-6) further discloses the first, second, third, and fourth ablation electrodes (electrodes A-D shown in annotated Figure 6 above) having approximately equal surface area to each other ([0055]-[0060], [0066]).
Regarding claim 13, Ebrahimi (Figures 1-6) further discloses each of the first, second, third, and fourth ablation electrodes (electrodes A-D shown in annotated Figure 6 above) defining a respective electrode region (electrode segments 446), each of the respective electrode regions (446) being disposed entirely in the right half of the planar body (flat body of element 400) or entirely in the left half of the planar body (flat body of element 400), ([0055]-[0060], [0066]).
Regarding claim 14, Ebrahimi (Figures 1-6) further discloses the planar body (flat body of element 400) comprising a planar high dielectric layer (442) overlapping and parallel to each of the plurality of ablation electrodes (electrodes A-D shown in annotated Figure 6 above), ([0055]-[000], [0066]).
Regarding claim 16, Ebrahimi (Figures 1-6) further discloses the planar body (flat body of element 400) comprising longitudinally elongated regions (446) comprising the planar high dielectric layer (substrate 442), lacking a framework, and lacking electrical circuitry ([0055]-[0060], [0066]).
Regarding claim 19, Ebrahimi (Figures 1-6) further discloses the second ablation electrode (electrode on second side corresponding/opposite to electrode C) being disposed on the second side of the planar body (flat body of element 400) and non-overlapping with the first ablation electrode (electrode B shown in annotated Figure 6 above), the planar body (flat body of element 400) having a left half and a right half as viewed on the first side, the left half being left of a centerline bisecting the planar body (flat body of element 400) along the longitudinal axis, the right half being right of the centerline, the first ablation electrode (electrode B shown in annotated Figure 6 above) defining a first electrode region disposed entirely in the left half, and the second ablation electrode (electrode on second side corresponding/opposite to electrode C) defining a second electrode region disposed entirely in the right half ([0055]-[0060], [0066]).
Regarding claim 20, Ebrahimi (Figures 1-6) further discloses the plurality of ablation electrodes (electrodes A-D shown in annotated Figure 6 above) comprising exactly two, three, or four ablation electrodes on the first side of the planar body (flat body of element 400) and exactly two, three, or four ablation electrodes on the second side of the planar body (flat body of element 400), ([0055]-[0060], [0066]).
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.
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) 15 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ebrahimi, as applied to claims 1 and 14 above, and further in view of Toth et al., (US 20160351292; hereinafter Toth).
Regarding claim 15, Ebrahimi discloses the end effector of claim 14, but fails to disclose the planar high dielectric layer comprising ceramic doped polymer. However, Toth (Figure 1) teaches a medical probe (100), ([0046]), wherein a dielectric material used for insulation may comprise a ceramic doped polymer ([0092]: ceramic loaded polymer). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ebrahimi to include the planar high dielectric layer comprising ceramic doped polymer, as taught by Toth, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.07.
Regarding claim 17, Ebrahimi (Figures 1-6) further discloses the planar body (flat body of element 400) comprising a plurality of longitudinally extending plates (446) being angled (in a serpentine shape) such that the plurality of longitudinally extending plates (446) are configured to overlap, longitudinal side on longitudinal side, upon retraction of the end effector (400) into a sheath (124), ([0055]-[0060], [0066]). Ebrahimi fails to disclose that the plurality of longitudinally extending plates are ceramic. However, Toth (Figure 1) teaches a medical probe (100), ([0046]), wherein a base dielectric material used for insulation may comprise a ceramic ([0092]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ebrahimi to include the plurality of longitudinally extending plates being ceramic, as taught by Toth, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.07.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ebrahimi, as applied to claim 1 above, and further in view of Maor, (US 20160113709).
Regarding claim 18, Ebrahimi (Figures 1-6) further discloses the end effector (400) being configured to provide pulse field ablation electrical pulses between pairs of ablation electrodes (pairs of electrodes A-D shown in annotated Figure 6 above) of the plurality of ablation electrodes (A-D), ([0067]), but fails to teach the pulses having a voltage of about 600 volts and about 1,200 volts. However, Maor teaches an end effector for a medical probe configured to provide pulse field ablation electrical pulses having a voltage of about 600 volts ([0221]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Ebrahimi to include the electrical pulses having a voltage of about 600 volts and about 1,200 volts, as taught by Maor, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE PREMRAJ whose telephone number is (571)272-8013. The examiner can normally be reached Monday - Friday: 8:00 AM - 5:00 PM.
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
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