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 .
Claim Objections
Claims 4, 13-14 objected to because of the following informalities:
Claim 4, line 1: “wherein in” should read --wherein--,
Claim 13, line 2: “comprise form” should read --form--,
Claim 14, line 3: “the a” should --a--.
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 1-15 & 18 are 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 “the path” in lines 11-12. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-8 are also rejected by virtue of their dependency on claim 1.
Regarding claim 9, the claim recites “a collapsed state” in line 11 and it is unclear if this is the same state as the “collapsed form” recited in line 4 or is a different state. For examination purposes, these are the same states and the limitation will be interpreted as “the collapsed form”.
Claim 9 recites the limitation “the path” in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claims 10-15 are also rejected by virtue of their dependency on claim 9.
Regarding claim 10, the claim recites “a slit” in line 3 and it is unclear if these are the same slits as the plurality of slits recited in claim 9, from which claim 10 depends, or if this is a different slit. For examination purposes, these are the same slits and the limitation will be interpreted as “a slit of the plurality of slits”.
Regarding claim 10, the claim recites “a collapsed state” in line 4 and it is unclear if this is the same state as the “collapsed form” recited claim 9, from which claim 10 depends, or is a different state. For examination purposes, these are the same states and the limitation will be interpreted as “the collapsed form”.
Claim 11 is also rejected by virtue of its dependency on claim 10.
Regarding claim 18, the claim recites “comprising nitinol …” but it is unclear what element from claim 16 comprises nitinol or the other materials listed, as it is unclear whether it is the expandable spine, the first electrode, the second electrode, the wire or combinations thereof. For examination purposes, the limitation will be interpreted as “wherein the expandable spine comprises nitinol…” until Applicant either amends or clarifies.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4, 9-10, 13, 16 & 19 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Govari et al. (U.S. Pub. No. 20150250424), herein referred to as “Govari”.
Regarding claim 1, Govari teaches an expandable spine assembly (Abstract: A medical probe includes an insertion tube for insertion into a patient's body, and multiple arms that are attached to a distal end of the insertion tube) comprising:
an expandable spine (arms 54; [0032]: During insertion of the catheter, the arms are grouped together in a collapsed position. After insertion into the heart cavity of interest, the arms are set to an expanded position as shown in FIG. 2) comprising a connecting portion that comprises a first slit facing an interior space formed by the expandable spine when the expandable spine is in an expanded state ([0033]: Each arm comprises a braid 55 of wires and each braid comprises multiple conductive wires to provide the braid mechanical support and flexibility; wherein one of the wires within the braid integrated onto the arm is seen as a slit since the wire occupies an indentation within the braid on the arm);
a first electrode (electrode 58 distal to the braid 55 in Fig. 2) attached to the expandable spine and disposed at a distal end of the first slit (see Fig. 2 where an electrode 58 is disposed at a distal end of the braid 55 & therefore is distal to the first slit);
a second electrode (electrode 58 proximal to the braid 55 in Fig. 2) attached to the expandable spine and disposed proximal to the first electrode and at a proximal end of the first slit (see Fig. 2 where an electrode 58 is disposed at a proximal end of the braid 55 & first electrode & therefore is proximal to them both); and
a wire (wires 55) configured to electrically connect the first and second electrodes ([0034]: In some embodiments, electrodes 58 and sensors 62 are electrically connected to selected pairs of wires in the braid, and these wires are used for transferring signals from the electrodes and sensors) and configured to be positioned within the first slit when the expandable spine is in a collapsed state and be positioned outside of the first slit such that the wire travels in a more direct path compared to the path of the connecting portion the first and second electrodes when in the expanded state ([0033]: Each arm comprises a braid 55 of wires and each braid comprises multiple conductive wires to provide the braid mechanical support and flexibility; wherein in this configuration, the braid is seen as providing each wire with its own slot that extends over a portion of the interior of the spine/arm such that upon expansion of the arms allows the wires to flex such that the wires are within their respective slits in the collapsed position and may be outside of their slits in the expanded state).
Regarding claim 4, Govari teaches wherein in the expandable spine is configured to curve away from the interior space when in the expanded state ([0032]: During insertion of the catheter, the arms are grouped together in a collapsed position. After insertion into the heart cavity of interest, the arms are set to an expanded position as shown in FIG. 2).
Regarding claim 9, Govari teaches an expandable basket assembly (Abstract: A medical probe includes an insertion tube for insertion into a patient's body, and multiple arms that are attached to a distal end of the insertion tube) comprising:
a plurality of spines (arms 54) extending along a longitudinal axis and configured to bow radially outward from the longitudinal axis when the expandable basket assembly is transitioned from a collapsed form to an expanded form ([0032]: During insertion of the catheter, the arms are grouped together in a collapsed position. After insertion into the heart cavity of interest, the arms are set to an expanded position as shown in FIG. 2);
a plurality of electrodes pairs (electrodes 58, a pair shown on each arm in Fig. 2), each electrode pair of the plurality of electrodes pairs being attached to a spine of the plurality of spines ([0033]: Each arm 54 comprises embedded sensors or electrodes, such as one or more mapping electrodes 58);
a plurality of slits facing an interior space formed by the expandable basket assembly when the expandable basket assembly is in the expanded form ([0033]: Each arm comprises a braid 55 of wires and each braid comprises multiple conductive wires to provide the braid mechanical support and flexibility; wherein one of the wires within the braid integrated onto the arm is seen as a slit since the wire occupies an indentation within the braid on the arm); and
a plurality of wires (wires 55) configured to electrically connect the plurality of electrode pairs ([0034]: In some embodiments, electrodes 58 and sensors 62 are electrically connected to selected pairs of wires in the braid, and these wires are used for transferring signals from the electrodes and sensors) and configured to be positioned within the plurality of slits when the expandable basket assembly is in a collapsed state and be positioned outside of the plurality of slits such that the plurality of wires travel in a more direct path compared to the path of the plurality of spines connecting the plurality of electrode pairs ([0033]: Each arm comprises a braid 55 of wires and each braid comprises multiple conductive wires to provide the braid mechanical support and flexibility; wherein in this configuration, the braid is seen as providing each wire with its own slot that extends over a portion of the interior of the spine/arm such that upon expansion of the arms allows the wires to flex such that the wires are within their respective slits in the collapsed position and may be outside of their slits in the expanded state).
Regarding claim 10, Govari teaches wherein at least one of the plurality of spines comprises a connecting portion disposed between a pair of electrodes of the plurality of electrode pairs, the connecting portion comprising a slit configured to receive a wire of the plurality of wires when the expandable basket assembly is in a collapsed state ([0033]: Each arm comprises a braid 55 of wires and each braid comprises multiple conductive wires to provide the braid mechanical support and flexibility; wherein one of the wires within the braid integrated onto the arm is seen as a slit since the wire occupies an indentation within the braid on the arm).
Regarding claim 13, Govari teaches wherein in the plurality of spines comprise form an approximately spherical shape or an approximately oblate-spheroid shape (see Fig. 2 where the arms in the expanded position form an approximately oblate-spheroid shape).
Regarding claim 16, Govari teaches an expandable spine assembly (Abstract: A medical probe includes an insertion tube for insertion into a patient's body, and multiple arms that are attached to a distal end of the insertion tube) comprising:
an expandable spine (arms 54; [0032]: During insertion of the catheter, the arms are grouped together in a collapsed position. After insertion into the heart cavity of interest, the arms are set to an expanded position as shown in FIG. 2) comprising a connecting portion ([0033]: Each arm comprises a braid 55 of wires and each braid comprises multiple conductive wires to provide the braid mechanical support and flexibility; wherein one of the wires within the braid integrated onto the arm is seen as a slit since the wire occupies an indentation within the braid);
a first electrode (electrode 58 distal to the braid 55 in Fig. 2) attached to the expandable spine at a distal end of the connecting portion (see Fig. 2 where an electrode 58 is disposed at a distal end of the braid 55 & therefore is distal to the braid);
a second electrode (electrode 58 proximal to the braid 55 in Fig. 2) attached to the expandable spine and disposed proximal to the first electrode and at a proximal end of the connecting portion (see Fig. 2 where an electrode 58 is disposed at a proximal end of the braid 55 & the first electrode & therefore is proximal to them both); and
a wire (wires 55) configured to electrically connect centers of the first and second electrodes ([0034]: In some embodiments, electrodes 58 and sensors 62 are electrically connected to selected pairs of wires in the braid, and these wires are used for transferring signals from the electrodes and sensors), be disposed separate from the connecting portion, and disposed within an interior space formed by the expandable spine in an expanded state ([0033]: Each arm comprises a braid 55 of wires and each braid comprises multiple conductive wires to provide the braid mechanical support and flexibility; wherein in this configuration, the braid is seen as providing each wire with its own slot that extends over a portion of the interior of the spine/arm such that upon expansion of the arms allows the wires to flex such that the wires are within their respective slits in the collapsed position and may be outside of their slits in the expanded state).
Regarding claim 19, Govari teaches wherein in the expandable spine is configured to curve away from the interior space when in the expanded state (see Fig. 2 where the arms 54 curve away from the interior space when in the expanded state).
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 2, 11 &17 are rejected under 35 U.S.C. 103 as being unpatentable over Govari as applied to claims 1, 9 & 16 above, and further in view of Goedeke et al. (U.S. Pub. No. 20180161577), herein referred to as “Goedeke”.
Regarding claim 2, Govari fails to explicitly disclose wherein an arc length of the connecting portion is greater than a length of the wire between the first and second electrodes when the expandable spine is in the expanded state.
However, Goedeke discloses wherein an arc length of the connecting portion is greater than a length of the wire between the first and second electrodes when the expandable spine is in the expanded state ([0842] FIG. 36L schematically illustrates another example of an expandable structure pattern. The parallel portions comprise a third non-diverging spline between the diverging parallel portions; wherein in this configuration, the middle spline is capable of having a shorter length than the arc length of the surrounding splines when the basket assembly is in the expanded state). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the expandable assembly of Govari to have the arc length and wire length, as taught by Goedeke, for the purpose of provide more flexibility in electrode positioning (Goedeke: [0842]).
Regarding claim 11, Govari fails to disclose wherein an arc length of the connecting portion is greater than a length of the wire when the expandable basket assembly is in the expanded form.
However, Goedeke discloses wherein an arc length of the connecting portion is greater than a length of the wire when the expandable basket assembly is in the expanded form ([0842] FIG. 36L schematically illustrates another example of an expandable structure pattern. The parallel portions comprise a third non-diverging spline between the diverging parallel portions; wherein in this configuration, the middle spline is capable of having a shorter length than the arc length of the surrounding splines when the basket assembly is in the expanded form). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the expandable assembly of Govari to have the arc length and wire length, as taught by Goedeke, for the purpose of provide more flexibility in electrode positioning (Goedeke: [0842]).
Regarding claim 17, Govari fails to disclose wherein an arc length of the connecting portion is greater than a length of the wire between the first and second electrodes when the expandable spine is in the expanded state.
However, Goedeke discloses wherein an arc length of the connecting portion is greater than a length of the wire between the first and second electrodes when the expandable spine is in the expanded state ([0842] FIG. 36L schematically illustrates another example of an expandable structure pattern. The parallel portions comprise a third non-diverging spline between the diverging parallel portions; wherein in this configuration, the middle spline is capable of having a shorter length than the arc length of the surrounding splines when the basket assembly is in the expanded state). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the expandable assembly of Govari to have the arc length and wire length, as taught by Goedeke, for the purpose of provide more flexibility in electrode positioning (Goedeke: [0842]).
Claims 3, 7-8, 12, 14-15, 18 & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Govari as applied to claims 1, 9 & 16, above, and further in view of Govari et al. (U.S. Pub. No. 20220071696), herein referred to as “Govari 2”.
Regarding claim 3, Govari fails to disclose comprising nitinol, cobalt chromium, stainless steel, titanium, or combinations thereof.
However, Govari 2 discloses comprising nitinol, cobalt chromium, stainless steel, titanium, or combinations thereof ([0050]: Spines 82 may have elliptical (e.g., circular) or rectangular (that may appear to be flat) cross-sections, and typically comprise a flexible, resilient material (e.g., a shape-memory alloy such nickel-titanium, also known as Nitinol)). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the expandable spines of Govari to comprise nitinol, as taught by Govari 2, for the purpose of enabling the spines to be flexible and resilient (Govari 2: [0050]).
Regarding claim 7, Govari fails to disclose wherein the first and second electrodes are coupled to the expandable spine and the first and second electrodes each define a lumen so that the expandable spine extends through the respective lumens.
However, Govari 2 discloses wherein the first and second electrodes are coupled to the expandable spine and the first and second electrodes each define a lumen so that the expandable spine extends through the respective lumens ([0067]: FIGS. 6 and 7 are longitudinal views of fitting lumen 70 of a given electrode body 40 on a given spine 82 (as indicated by an arrow 150 in FIG. 6)). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the first and second electrodes of Govari to each define lumens, as taught by Govari 2, for the purpose of preventing the given electrode from “breaking off” basket assembly (Govari 2: [0068]).
Regarding claim 8, Govari discloses wherein the first and second electrodes are configured to deliver electrical pulses for irreversible electroporation ([0010]: one or more of the electrodes include ablation electrodes that are configured to perform ablation of tissue in response to an ablation signal; wherein electrodes capable of delivering ablation signals are capable of both thermal ablation and electroporation), Govari fails to explicitly disclose the electrical pulses having a peak voltage of at least 900 volts (V).
However, Govari 2 discloses wherein the first and second electrodes are configured to deliver electrical pulses for irreversible electroporation, the electrical pulses having a peak voltage of at least 900 volts (V) ([0044]: IRE ablation module 56 is configured to generate IRE pulses comprising peak power in the range of tens of kilowatts. As described hereinbelow, medical system 20 performs IRE ablation by delivering IRE pulses to pairs of electrodes 40). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the electrical pulses of Govari to have a peak voltage of at least 900 volts, as taught by Govari 2, for the purpose of enabling nonthermal ablation based on the unrecoverable permeabilization of cell membranes caused by short pulses of high voltage delivered to the tissue (Govari: [0003]).
Regarding claim 12, Govari fails to disclose wherein at least one spine of the plurality of spines comprises nitinol, cobalt chromium, stainless steel, titanium, or combinations thereof.
However, Govari 2 discloses wherein at least one spine of the plurality of spines comprises nitinol, cobalt chromium, stainless steel, titanium, or combinations thereof ([0050]: Spines 82 may have elliptical (e.g., circular) or rectangular (that may appear to be flat) cross-sections, and typically comprise a flexible, resilient material (e.g., a shape-memory alloy such nickel-titanium, also known as Nitinol)). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the expandable spines of Govari to comprise nitinol, as taught by Govari 2, for the purpose of enabling the spines to be flexible and resilient (Govari 2: [0050]).
Regarding claim 14, Govari fails to disclose wherein the plurality of electrode pairs are coupled to respective spines of the plurality of spines and each define a lumen so that the a respective spine extends through the lumen.
However, Govari 2 discloses wherein the plurality of electrode pairs are coupled to respective spines of the plurality of spines and each define a lumen so that the a respective spine extends through the lumen ([0067]: FIGS. 6 and 7 are longitudinal views of fitting lumen 70 of a given electrode body 40 on a given spine 82 (as indicated by an arrow 150 in FIG. 6)). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the first and second electrodes of Govari to each define lumens, as taught by Govari 2, for the purpose of preventing the given electrode from “breaking off” basket assembly (Govari 2: [0068]).
Regarding claim 15, Govari discloses wherein the plurality of electrode pairs are configured to deliver electrical pulses for irreversible electroporation ([0010]: one or more of the electrodes include ablation electrodes that are configured to perform ablation of tissue in response to an ablation signal; wherein electrodes capable of delivering ablation signals are capable of both thermal ablation and electroporation), but Govari fails to explicitly disclose the electrical pulses having a peak voltage of at least 900 volts (V).
However, Govari 2 discloses wherein the plurality of electrode pairs are configured to deliver electrical pulses for irreversible electroporation, the electrical pulses having a peak voltage of at least 900 volts (V) ([0044]: IRE ablation module 56 is configured to generate IRE pulses comprising peak power in the range of tens of kilowatts. As described hereinbelow, medical system 20 performs IRE ablation by delivering IRE pulses to pairs of electrodes 40). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the electrical pulses of Govari to have a peak voltage of at least 900 volts, as taught by Govari 2, for the purpose of enabling nonthermal ablation based on the unrecoverable permeabilization of cell membranes caused by short pulses of high voltage delivered to the tissue (Govari: [0003]).
Regarding claim 18, Govari fails to disclose comprising nitinol, cobalt chromium, stainless steel, titanium, or combinations thereof.
However, Govari 2 discloses comprising nitinol, cobalt chromium, stainless steel, titanium, or combinations thereof ([0050]: Spines 82 may have elliptical (e.g., circular) or rectangular (that may appear to be flat) cross-sections, and typically comprise a flexible, resilient material (e.g., a shape-memory alloy such nickel-titanium, also known as Nitinol)). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the expandable spines of Govari to comprise nitinol, as taught by Govari 2, for the purpose of enabling the spines to be flexible and resilient (Govari 2: [0050]).
Regarding claim 20, Govari fails to disclose wherein the first and second electrodes are coupled to the expandable spine and the first and second electrodes each define a lumen so that the expandable spine extends through the lumen.
However, Govari 2 discloses wherein the first and second electrodes are coupled to the expandable spine and the first and second electrodes each define a lumen so that the expandable spine extends through the lumen ([0067]: FIGS. 6 and 7 are longitudinal views of fitting lumen 70 of a given electrode body 40 on a given spine 82 (as indicated by an arrow 150 in FIG. 6)). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the first and second electrodes of Govari to each define lumens, as taught by Govari 2, for the purpose of preventing the given electrode from “breaking off” basket assembly (Govari 2: [0068]).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Govari as applied to claim 1 above, and further in view of Willard et al. (U.S. Pub. No. 20140025069), herein referred to as “Willard”.
Regarding claim 5, Govari fails to disclose an electrically insulative jacket disposed between the first and second electrodes and the expandable spine, thereby electrically isolating the first and second electrodes from the expandable spine.
However, Willard discloses an electrically insulative jacket disposed between the first and second electrodes and the expandable spine, thereby electrically isolating the first and second electrodes from the expandable spine ([0051]: the entire frame 113 may be formed of any material desired and may be coated with an insulating material. Discrete individual electrodes 112, 114 may be affixed to the insulating material of the frame 113 … modulation system 100 may include separate electrical conductors for supplying energy to the electrodes). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the expandable spine assembly of Govari to include an electrically insulative jacket, as taught by Willard, for the purpose of providing electrical separation (Willard: [0055]).
Regarding claim 6, Govari in view of Willard disclose wherein the electrically insulative jacket comprises a second slit that corresponds with the first slit and comprises polyether keytone (PEEK), liquid crystal polymer (LCP), or both (Willard: [0051]: the entire frame 113 may be coated with an insulating material, with discrete areas of insulation later removed; [0097]: Some examples of suitable polymers that may be suitable for use in system 100 may include … polyetheretherketone (PEEK)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Ziegler whose telephone number is (571)272-1991. The examiner can normally be reached M-F 8:30 a.m. - 5 p.m. EST.
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794