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 1, 5-10 and 12-24 are objected to because of the following informalities:
Claim 1 recites “the electrical parameter” in line 22, which seems like it should recite “the measured electrical parameter” in light of the previously recited “measure an electrical parameter”.
Claim 1 recites “the tissue” in line 23, which should recite “the tissue around the wall of the LAA” in order to provide consistent terminology throughout the claim language.
Claim 5 recites “and tissue energizing module” in lines 3-4, which should recite “and the tissue energizing module” to provide proper antecedence. Appropriate correction is required.
Claim 6 recites “a section of the wall” in lines 2-3, which should recite “a second of the wall of the LAA” in order to provide consistent terminology throughout the claim language.
Claim 6 recites “the section” in line 4 and “the section of tissue” in line 8, both should recite “the section of the wall of the LAA” in order to provide consistent terminology throughout the claim language. Subsequent recitations should be likewise corrected.
Claim 7 recites “perform steps”, which should recite “perform the steps” in order to provide proper antecedence.
Claim 24 recites “that one or more tissue areas” in lines 3-4, which should recite “that the one or more tissue areas” in order to provide proper antecedence.
Claim 24 recites “to one or more tissue areas” in line 5, which should recite “to the one or more tissue areas” in order to provide proper antecedence.
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, 5-10 and 12-24 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 “configured to energise the plurality of electrodes or a plurality of sets of the plurality of electrodes” in lines 14-15 and 25-26 of the claim. There is insufficient antecedent basis for this limitation in the claim in light of the recitation of “a plurality of electrodes” in line 8 of the claim. It is not clear if there are multiple plurality of electrodes or if the plurality of electrodes is being further defined as a plurality of sets of electrodes. Subsequent recitations of “the plurality of electrodes” in dependent claims are then additionally unclear since this may or may not be further defined as a plurality of sets of electrodes. Applicant can further define the plurality of electrodes to be a plurality of sets, but then that language needs to be used consistently throughout the claims so it is clear what is being claimed.
Claim 23 recites “based on an electrical parameter profile” in line 18 of the claim. There is insufficient antecedent basis for this limitation in the claim in light of the recitation of “an electrical parameter of the tissue’ in lines 13-14 and “the electrical parameter comprising an electrical impedance or electrical activity” in lines 14-15 of the claim. It is not clear if or how an electrical parameter profile is related to these previously recited electrical parameters.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 5-10, 12-15, 19-21, 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Gruba et al (2020/0008870) in view of Fleischman et al (6,416,505).
Referring to claim 1, Gruba et al teaches a device to occlude a left atrial appendage (LAA) of a heart of a subject (paragraphs 0059-0060; Figure 7), comprising: an implantable occlusion apparatus (212) configured for radial expansion upon deployment to fluidically occlude the LAA (paragraph 0094); an elongated catheter member (218) having a distal end attachable to the implantable occlusion apparatus for transluminal delivery of the implantable occlusion apparatus to the LAA (paragraph 0080; Figure 6); a tissue energizing module (214) having a plurality of electrodes disposed around a circumference of the implantable occlusion apparatus in which each of the plurality of electrodes is configured to contact a wall of the LAA at a tissue focal point upon deployment of the implantable occlusion apparatus (paragraph 0092); and an electrical controller (252) including a pulsed field energy delivery generator operably attachable to an electrical power source (50) and the plurality of electrodes (214) and configured to energize the plurality of electrodes in a pulsed field ablation modality (paragraph 0100),
Gruba et al teaches a tissue parameter sensor (126) configured to measure an electrical parameter of one section of the tissue around the wall of the LAA (paragraph 0068) the device comprises a processor operably coupled to the electrical controller and configured to generate an electrical parameter profile of the LAA from the measured electrical parameter of the plurality of circumferential sections of the tissue around the wall of the LAA and wherein the electrical parameter is electrical impedance or electrical activity (paragraphs 0060, 0067 and 0068; Figures 6-8).
Gruba et al fails to teach that the electrical controller is configured to energize the plurality of electrodes independently to apply a non-uniform pulsed field ablation treatment circumferentially around the wall of the left atrial appendage and modify the output of the electrical controller so as to independently energize the electrodes. Fleischman et al teaches an analogous device for treating the heart (Col. 6, lines 8-16) comprising an electrical controller is configured to energize the plurality of electrodes independently to apply a non-uniform pulsed field ablation treatment circumferentially around the wall of the left atrial appendage and modify the output of the electrical controller so as to independently energize the electrodes or sets of electrodes in a pattern synergistic with the tissue parameter profile to energize some electrodes or sets of electrodes with greater ablative power than others to create a non-uniform tissue ablation circumferentially around the wall of the LAA, tuned to the specific anatomy of the subject (Col. 38, lines 1-40 and Col. 50, line 1 through Col. 51, line 3). 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 controller, as taught by Gruba et al, to energize the plurality of electrodes independently to apply a non-uniform pulsed field ablation treatment circumferentially around the wall of the left atrial appendage and modify the output of the electrical controller so as to independently energize the electrodes, as taught by Fleishman et al, in order to allow the physician to selectively control the supply of power to individual electrodes (Col. 31, lines 56-58).
It is noted that the prior art does not need to be specifically targeting the LAA since this is an apparatus claim the prior art needs to only be capable of occluding the LAA. Additionally, lines 19-20 of the claim recite “a tissue parameter sensor configured to measure an electrical parameter of one or a plurality of circumferential sections of the tissue around the wall of the LAA” (emphasis added) and as such subsequent recitations referring to a plurality of circumferential sections are therefore not required.
Referring to claim 5, the modified Gruba teaches the tissue parameter sensor comprises the electrical controller and the tissue energizing module and in which the processor is configured to actuate the controller and tissue energizing module in at least two separate modalities selected from: a tissue ablation modality configured to deliver a pulsed field ablation treatment at one or more sections around the circumference of the wall of the LAA (paragraphs 0060, 0080, 0092-0094 and 0100 of Gruba and Col. 38, lines 1-40 and Col. 50, line 1 through Col. 51, line 3 of Fleischman).
Referring to claim 6, the modified Gruba teaches processor is configured to (a) compare the electrical parameter measurement for a section of the wall with a reference electrical parameter value, (b) calculate a pulsed field ablation power to be delivered to the section based on comparing the electrical parameter measurement with the reference electrical parameter value, and (c) modify the output characteristics of the electrical controller to independently energize selected electrodes of the plurality of electrodes to deliver pulse field ablation therapy to the section of tissue at the calculated power (paragraphs 0060, 0080, 0092-0094 and 0100 of Gruba and Col. 38, lines 1-40 and Col. 50, line 1 through Col. 51, line 3 of Fleischman).
Referring to claims 7 and 8, the modified Gruba reference teaches wherein the processor is configured to perform steps (a), (b) and (c) for each of a plurality of sections of the wall of the LAA and in which the plurality of sections together make up a full circumference of the LAA (paragraphs 0060, 0080, 0092-0094 and 0100 of Gruba and Col. 38, lines 1-40 and Col. 50, line 1 through Col. 51, line 3 of Fleischman).
Referring to claim 9, Gruba et al teaches that the controller is configured to measure electrical impedance across a section of the wall of the LAA by configuring one pair of electrodes of the plurality of electrodes to supply measuring current and a separate pair of electrodes of the plurality of electrodes to detect voltage drop produced by current flowing across the section of tissue (paragraphs 0060, 0080, 0092-0094 and 0100).
Referring to claim 10, Gruba et al teaches having at least four electrodes (214) circumferentially spaced around the wall of the occlusion apparatus (Figures 6).
Referring to claim 12, Gruba et al teaches the device is configured to: deliver by the controller and electrodes a pulsed field ablation treatment at a section of the wall of the body lumen, determine by the controller and electrodes an electrical impedance value of the tissue at the treated section; and correlate by the processor an output indication of electrical isolation of the section of the wall of the body lumen based on the electrical impedance value (paragraphs 0060, 0061, 0066, 0067, 0073, 0080, 0092-0096 and 0100). Gruba specifically teaches that the energy source and/or the mapping source measure impedance to determine when the ablation procedure is complete (paragraph 0061).
Referring to claim 13, Gruba et al teaches wherein the processor is configured to receive as an input the measured electrical impedance value for the section of tissue, compare the value with one or more reference electrical impedance values, and calculate an output indication of electrical isolation of the section of the wall based on the comparison (paragraphs 0060, 0061, 0066, 0067, 0073, 0080, 0092-0096 and 0100). Gruba specifically teaches that the energy source and/or the mapping source measure impedance to determine when the ablation procedure is complete (paragraph 0061).
Referring to claim 14, the modified Gruba reference teaches in which the device is configured to: determine by the controller and electrodes a first electrical parameter value selected from an electrical impedance or electrical activity of tissue at a section of the wall of the body lumen, deliver by the controller and electrodes a pulsed field ablation treatment at the section of the wall of the body lumen, determine by the controller and electrodes a second electrical parameter value selected from an electrical impedance or electrical activity of the tissue at the treated section; and calculate by the processor an output indication of electrical isolation of the section of the wall of the body lumen based on a comparison of the first and second electrical parameter measurements (paragraphs 0060, 0080, 0092-0094 and 0100 of Gruba and Col. 38, lines 1-40 and Col. 50, line 1 through Col. 51, line 3 of Fleischman).
Referring to claim 15, Gruba et al teaches an earth electrode configured for attachment to a surface of the subjects body, in which the processor is configured to determine the electrical parameter of the tissue at a specific location using an electrode of the tissue energizing module and the earth electrode (paragraphs 0064, 0084, 0090 and 0099).
Referring to claim 19, Gruba et al teaches a device capable of which the pattern synergistic with the electrical parameter profile of the LAA is configured to generate a non-uniform e-field which is higher in a first set of circumferential sections around the wall of the LAA and lower in a second set of circumferential sections around the wall of the LAA (paragraphs 0060, 0067 and 0068; Figures 6-8). This is a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. No additional structural elements are required by this claim.
Referring to claim 20, Gruba et al teaches an electrical parameter is electrical impedance and is capable of having the first set of circumferential sections correspond to circumferential sections of the tissue with a low tissue impedance measure and the second set of circumferential sections correspond to circumferential sections of the tissue with a high tissue impedance measure (paragraphs 0060, 0067 and 0068; Figures 6-8). This is a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim
Referring to claim 21, Gruba et al teaches the electrical parameter is electrical activity and is capable of having the first set of circumferential sections correspond to circumferential sections of the tissue with a low tissue activity measure and the second set of circumferential sections correspond to circumferential sections of the tissue with a high tissue activity measure (paragraphs 0060, 0067 and 0068; Figures 6-8). This is a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim
Referring to claim 23, Gruba et al teaches a device to occlude a left atrial appendage (LAA) of a heart (paragraphs 0059-0060; Figure 7), comprising: an implantable occlusion apparatus (212) configured for radial expansion upon deployment (paragraphs 0094); an elongated catheter member (218) having a distal end attachable to the implantable occlusion apparatus (paragraphs 0080 and 0090; Figure 6); a tissue energising module (214) comprising: a plurality of electrodes disposed around a circumference of the implantable occlusion apparatus (paragraphs 0090 and 0092); an electrical controller (252) including a pulsed field energy delivery generator configured to energise a plurality of the electrodes in a pulsed field ablation modality (paragraphs 0092 and 0099); a tissue parameter sensor configured to measure an electrical parameter of the tissue around a wall of the LAA (paragraph 0064), the electrical parameter comprising an electrical impedance or electrical activity (paragraphs 0061, 0064, 0066-0067 and 0092); and a processor operably coupled to the electrical controller (paragraphs 0060 and 0068), in which the electrical controller is configured to energise the plurality of electrodes independently to apply a non-uniform pulsed field ablation treatment configured to modify an output of the electrical controller so as to independently energise the plurality of electrodes based on an electrical parameter profile.
Gruba et al fails to teach wherein the electrical controller is configured to energise the plurality of electrodes independently to apply a non-uniform pulsed field ablation treatment and configured to modify an output of the electrical controller so as to independently energise the plurality of electrodes based on an electrical parameter profile. Fleischman et al teaches an analogous device for treating the heart (Col. 6, lines 8-16) comprising an electrical controller is configured to energise the plurality of electrodes independently to apply a non-uniform pulsed field ablation treatment and configured to modify an output of the electrical controller so as to independently energise the plurality of electrodes based on an electrical parameter profile (Col. 38, lines 1-40 and Col. 50, line 1 through Col. 51, line 3). 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 controller and processor, as taught by Gruba et al, to energise the plurality of electrodes independently to apply a non-uniform pulsed field ablation treatment and configured to modify an output of the electrical controller so as to independently energise the plurality of electrodes based on an electrical parameter profile, as taught by Fleischman et al, in order to allow the physician to selectively control the supply of power to individual electrodes (Col. 31, lines 56-58).
Referring to claim 24, Gruba et al teaches wherein the electrical parameter of the tissue includes an impedance level corresponding to one or more tissue areas, and is capable of outputting to each of the plurality of electrodes is modified such that one or more tissue areas having a higher impedance level receive lower power in comparison to one or more tissue areas having a lower impedance level (paragraphs 0060, 0067 and 0068; Figures 6-8). This is a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Gruba et al (2020/0008870) in view of Fleischman et al (6,416,505) as applied to the claims above, and further in view of Stewart et al (2019/0223948).
Referring to claims 16-18, Gruba et al teaches the pulse train includes a voltage of approximately 500 to 2500 volts (paragraph 0007). Due to a lack of criticality and unexpected results 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 pulsed field energy delivery generator, as taught by Gruba et al, to deliver a voltage of approximately 500 to 2500 volts 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. In re Aller, 105 USPQ 233.
Gruba et al fails to teach each pulse train of energy including: inter-phase delay between 0 μs and 5 μs, an inter-pulse delay of 2 to 500 μs, a pulse width of 1 to 15 μs, and a voltage of 500 to 2500 V. Stewart et al teaches an analogous device for treating the hear comprising a pulsed field energy delivery generator configured to deliver inter-phase delay between 0 μs and 5 μs, an inter-pulse delay of 2 to 500 μs, a pulse width of 1 to 15 μs (paragraph 0004). 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 pulsed field energy delivery generator, as taught by Gruba et al, to deliver inter-phase delay between 0 μs and 5 μs, an inter-pulse delay of 2 to 500 μs, a pulse width of 1 to 15 μs, as taught by Stewart et al, in order to not cause collateral damage to non-targeted (paragraph 0004). Due to a lack of criticality and unexpected results 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 pulsed field energy delivery generator, as taught by Gruba et al, to deliver at least 60 pulses 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. In re Aller, 105 USPQ 233.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Gruba et al (2020/0008870) in view of Fleischman et al (6,416,505) as applied to the claims above, and further in view of Auth et al (2006/0122680).
Referring to claim 22, Gruba et al teaches that the electrical parameter is electrical activity (paragraphs 0060, 0067 and 0068; Figures 6-8), however fails to teach that the electrical activity comprises a measured voltage. Auth et al teaches an analogous cardiac device (paragraph 0051) comprising a tissue parameter sensor comprising measuring voltage (paragraph 0020). 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 electrical parameter, as taught by Gruba et al, to be measured voltage, as taught by Auth et al, in order to aid the surgeon in guiding the catheter, and to prevent from supplying excessive energy to the cardiac tissue (paragraph 0020).
Response to Arguments
Applicant's arguments filed March 27, 2026 have been fully considered but they are not persuasive. Applicant argues that the modified Gruba reference fails to teach a processor configured to generate an electrical parameter profile of the LAA from the electrical parameter of the plurality of circumferential sections of the tissue and modify an output of the electrical controller so as to independently energise the plurality of electrodes or the sets of the plurality of electrodes in a pattern synergistic with the electrical parameter profiled of the LAA, however the examiner respectfully disagrees. First off, as currently written claim one in lines 19-20 recite “a tissue parameter sensor configured to measure an electrical parameter of one or a plurality of circumferential sections of the tissue around the wall of the LAA” (emphasis added) and as such subsequent recitations referring to a plurality of circumferential sections are therefore not required. However, even if they were the combination of references meet the limitation of the claim.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). None of the presented arguments address the teachings of Fleischman et al.
Gruba et al teaches a processor configured to generate an electrical parameter profile of the LAA from the measured electrical parameter of the plurality of circumferential sections of the tissue around the wall of the LAA (paragraphs 0060, 0067 and 0068; Figures 6-8), however fails to teach that the electrical controller is configured to energize the plurality of electrodes independently to apply a non-uniform pulsed field ablation treatment circumferentially around the wall of the left atrial appendage and modify the output of the electrical controller so as to independently energize the electrodes. Fleischman et al teaches an analogous device for treating the heart (Col. 6, lines 8-16) comprising an electrical controller is configured to energize the plurality of electrodes independently to apply a non-uniform pulsed field ablation treatment circumferentially around the wall of the left atrial appendage and modify the output of the electrical controller so as to independently energize the electrodes or sets of electrodes in a pattern synergistic with the tissue parameter profile to energize some electrodes or sets of electrodes with greater ablative power than others to create a non-uniform tissue ablation circumferentially around the wall of the LAA, tuned to the specific anatomy of the subject (Col. 38, lines 1-40 and Col. 50, line 1 through Col. 51, line 3). 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 controller, as taught by Gruba et al, to energize the plurality of electrodes independently to apply a non-uniform pulsed field ablation treatment circumferentially around the wall of the left atrial appendage and modify the output of the electrical controller so as to independently energize the electrodes, as taught by Fleishman et al, in order to allow the physician to selectively control the supply of power to individual electrodes (Col. 31, lines 56-58).
It is noted that the prior art does not need to be specifically targeting the LAA since this is an apparatus claim the prior art needs to only be capable of occluding the LAA. Applicant’s representative is encouraged to contact the examiner to discuss ways to further prosecution after a power of attorney has been filed.
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 SAMANTHA M GOOD whose telephone number is (571)270-7480. The examiner can normally be reached Mon to Wed, 7am to 3pm.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SAMANTHA M GOOD/ Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/ Primary Examiner, Art Unit 3794
Prosecution Insights