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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/26/2024 is being considered by the examiner.
Claim Objections
Claim 15 is objected to because of the following informalities: Claims 15 and 19, line 3 read "to the heat" should read "to the heart". Appropriate correction is required.
Applicant is advised that should claim 13 be found allowable, claim 16 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. Similarly, should claim 15 be found allowable, claim 19 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 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 "tissue" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Dependent claims inherit the same deficiencies.
Claim 20 recites the limitation "tissue" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 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 1-3, 5-11, 14 and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ahmad et al. (US 10471257 B2), hereinafter Ahmad.
Regarding claim 1, Ahmad teaches a medical device (Fig. 2, element 22 – pulse generator) comprising:
an elongated structure (Fig. 2, element 60 – electrical lead) configured to extend from an access point of a patient (col. 2, 23-25 (sheath has a lumen extending therethrough that is sized and configured to accommodate both the electrical lead and the tunneler), col. 2, lines 48-50 (inserting through an incision in the patient's skin the sheath with the tunneler disposed therein)) through an intercostal space within the patient (Fig. 13 & 15 – shows the patient’s ribs and a plurality of intercostal nerve bundles, as well as the electrical lead 70 being implanted); and
a plurality of electrodes (col. 5, lines 4-5 (distal portion comprises a plurality of electrodes)) comprising a first subset of electrodes (Fig. 2, element 62 – plurality of electrodes) and a second subset of electrodes (Fig. 2, element 16 – plurality of electrodes),
wherein at least the first subset of electrodes is carried on a distal portion of the elongated structure (col. 5, lines 4-5 (distal portion comprises a plurality of electrodes)),
wherein the first subset of electrodes of the plurality of electrodes is configured to deliver electrical therapy to a heart of the patient or sense cardiac activity (col. 8, lines 42-44 (can also be connected to pulse generator 22 to apply an electromagnetic field to intercostal nerve bundles)), and
wherein the second subset of electrodes of the plurality of electrodes is configured to deliver energy to tissue proximate a ribcage of the patient (col. 2, lines 52-55 (sheath can be positioned substantially perpendicular to the patient's ribs or intercostal nerve bundles or substantially parallel to the patient's ribs or intercostal nerve bundles)) to reduce a sensation in one or more intercostal nerves (col. 4, lines 21-23 (devices for delivering an intercostal nerve block to alleviate pain in a patient suffering therefrom), col. 2, lines 15-17 (an electromagnetic field is applied to the plurality of intercostal nerve bundles after the surgery)).
Regarding claim 2, Ahmad teaches the medical device of claim 1, wherein to deliver energy to tissue proximate the ribcage of the patient, the second subset of electrodes is configured to deliver at least one of peripheral nerve stimulation or electroporation energy anterior to the heart to reduce pain associated with extension of the elongated structure through the intercostal space (col. 5, lines 14-16 (an electrode 16 of the plurality of electrodes is placed over each of a plurality of intercostal nerve bundles 20 of the patient's body), col. 5, lines 31-33 (an electromagnetic field is then applied via pulse generator 22 to the plurality of intercostal nerve bundles 20)).
Regarding claim 3, Ahmad teaches the medical device of claim 1, wherein at least a portion of the second subset of electrodes is configured to be oriented toward the intercostal space (col. 2, lines 57-61 (distal portion of the electrical lead is oriented such that the plurality of un-insulated electrically conductive sections is facing towards the plurality of intercostal nerve bundles and away from the cutaneous fibers of the patient's body)).
Regarding claim 5, Ahmad teaches the medical device of claim 1, wherein the second subset of electrodes is configured to remain implanted after the elongated structure is navigated through the patient (Fig. 16 illustrates the subset of electrodes remaining after implantation).
Regarding claim 6, Ahmad teaches the medical device of claim 1, wherein the second subset of electrodes is carried by the elongated structure (col. 5, line 4 (distal portion 14 comprises a plurality of electrodes 16)).
Regarding claim 7, Ahmad teaches the medical device of claim 1, wherein the second subset of electrodes is carried by the elongated structure (col. 5, line 4 (distal portion 14 comprises a plurality of electrodes 16)) such that the second subset of electrodes is positioned in the intercostal space when implanted within the patient (Fig. 2).
Regarding claim 8, Ahmad teaches the medical device of claim 1, wherein the second subset of electrodes is carried by a medical device housing (Fig. 2, element 22 – pulse generator), the medical device housing configured to couple to the elongated structure (col. 2, lines 62-64 (proximal portion of the electrical lead is connected to a pulse generator)).
Regarding claim 9, Ahmad teaches the medical device of claim 1, wherein the second subset of electrodes is carried by a delivery device, wherein the delivery device is configured to deliver the elongated structure to an implant location within the patient (col. 2, 23-25 (sheath has a lumen extending therethrough that is sized and configured to accommodate both the electrical lead and the tunneler), col. 2, lines 48-50 (inserting through an incision in the patient's skin the sheath with the tunneler disposed therein), Fig. 15 - shows the electrical lead 70 being implanted)).
Regarding claim 10, Ahmad teaches the medical device of claim 1, wherein the elongated structure is a first elongated structure (Fig. 2, element 60), wherein the medical device further comprises: a second elongated structure (Fig. 2, element 11 – lead body), wherein the second subset of electrodes is carried on the second elongated structure (col. 5, line 4 (distal portion 14 comprises a plurality of electrodes 16)).
Regarding claim 11, Ahmad teaches the medical device of claim 1, wherein the tissue comprises at least one of muscle tissue or nerve tissue (col. 5, lines 22-24 (electrodes are preferably placed as close to the intercostal nerve bundles as possible and can be fixated to adjacent tissue, such as intercostal muscles)).
Regarding claims 14 and 18, Ahmad teaches the medical device of claim 1, further comprising a shield (Fig. 5A, element 41 – insulated cover) configured to impede delivery of energy from the second subset of electrodes toward the heart or an intercostal vascular bundle (col. 6, lines 18-21 (lead can include an insulated cover… to shield the non-stimulation surface from receipt of the current)).
Regarding claim 17, Ahmad teaches the medical device of claim 1, wherein the elongated structure is a catheter, an introducer, or an implantable medical lead (Fig. 2, element 1 – electrical lead).
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ahmad and in view of Dham et al. (US 20220305256 A1), hereinafter Dham.
Regarding claim 4, Ahmad teaches the medical device of claim 1, and the first subset of electrodes (Fig. 2, element 62 – electrode) and the second subset of electrodes (Fig. 2, element 16 – electrode).
Ahmad does not teach wherein the first and second subset of electrodes share at least one common electrode.
Dham teaches a first subset of electrodes (Fig. 1A, element 502 – far field electrodes) and a second subset of electrodes (Fig. 1A, element 504 – near-field electrodes) share at least one common electrode (para. 0057 (far-field electrodes 502 and near-field electrodes 504 may share at least one common electrode)).
Ahmad and Dham are considered to be analogous to the claimed invention because they are in the same field of implantable leads coupled to a pulse generator. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ahmad’s first and second subset of electrodes to incorporate the common electrode taught by Dham, and provide a common electrode between the two subsets of electrodes. Dham teaches a plurality of leads that are implanted within the heart, and a generator, that may serve as a far-field electrode or near-field electrode (para. 0057). Therefore, by incorporating a common electrode within the generator, allows for sensing of leads without the need to reposition the lead.
Claims 12, 13, 15-16, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ahmad and in view of Sanghera et al. (US 20210370080 A1), hereinafter Sanghera.
Regarding claim 12, Ahmad teaches the medical device of claim 1, wherein to deliver electrical therapy to the heart of the patient (col. 8, lines 42-44 (can also be connected to pulse generator 22 to apply an electromagnetic field to intercostal nerve bundles)), and the first subset of electrodes (Fig. 2, element 62 – electrode).
Ahmad does not explicitly disclose pacing or cardioversion/defibrillation shock to the heart of the patient.
Sanghera teaches a first subset of electrodes configured to provide one or more pacing or cardioversion/defibrillation shock to the heart of the patient (para. 0009 (an initial set of electrodes on a defibrillation lead including more than two defibrillation electrodes, from which to deliver a defibrillation pulse), 0160 (distal portion of the lead may include defibrillation electrodes or cardiac pacing electrodes), 0164 (lead wires can conduct defibrillation and pacing pulses and/or sensing signals to and/or from a connected pulse generator)).
Ahmad and Sanghera are considered to be analogous to the claimed invention because they are in the same field of implantable leads in the intercostal area, coupled to a pulse generator. Ahmad teaches electrodes electrically coupled to a pulse generator (col. 5, lines 12-13). Sanghera teaches lead wires are connected to a pulse generator to conduct defibrillation (para. 0164). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ahmad’s first subset of electrodes to incorporate the defibrillation shock taught by Sanghera. Doing so improves the medical device, by allowing the generator to provide defibrillation, followed by electromagnetic therapy to alleviate pain, with the use of the electrodes.
Regarding claims 13 and 16, Ahmad teaches the medical device of claim 1, and the distal portion of the elongated structure (Fig. 2, element 60 – electrical lead).
Ahmad does not teach the distal portion being configured to deliver a therapy agent to tissue proximate the ribcage of the patient, and wherein the therapy agent comprises at least one of an anti-inflammatory agent, an analgesic agent, a neurotoxin, or an antimicrobial agent.
Sanghera teaches wherein a distal portion of an elongated structure (para. 0154 (electrode may be configured to couple with distal portion of lead)) is configured to deliver a therapy agent to tissue proximate the ribcage of the patient, and wherein the therapy agent comprises at least one of an anti-inflammatory agent, an analgesic agent, a neurotoxin, or an antimicrobial agent (0159 ([distal portion of the lead] are well-suited for implantation near and/or along a patient's sternum), 0157 (an anti-inflammatory agent may be incorporated … in hollow area to reduce the patient’s tissue inflammatory response)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ahmad’s distal portion of the elongated structure, to incorporate the therapy agent taught by Sanghera. Doing so reduces the tissue’s inflammatory response from the electrical therapy of the electrodes.
Regarding claims 15 and 19, Ahmad teaches the medical device of claim 1, and the first subset of electrodes (Fig. 2, element 62 – electrode).
Ahmad does not teach the first subset of electrodes comprising one or more coil electrodes configured to deliver defibrillation therapy, and wherein the first subset comprises one or more electrodes configured to deliver pacing to the heart or sense cardiac activity.
Sanghera teaches a first subset of electrodes comprising one or more coil electrodes (Fig. 27, element 2720 – coil electrodes) configured to deliver defibrillation therapy, and wherein the first subset comprises one or more electrodes configured to deliver pacing to the heart or sense cardiac activity (para. 0160 (distal portion of the lead may include defibrillation electrodes or cardiac pacing electrodes)
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ahmad’s first subset of electrodes to incorporate the coil electrode taught by Sanghera, and provide a coil electrode to deliver defibrillation therapy. Doing so increases the surface area of the electrode for defibrillation.
Regarding claim 20, Ahmad teaches a medical device (Fig. 2, element 22 – pulse generator) comprising:
a cardiac lead (Fig. 2, element 60 – electrical lead) configured to extend from an access point of a patient (col. 2, 23-25 (sheath has a lumen extending therethrough that is sized and configured to accommodate both the electrical lead and the tunneler), col. 2, lines 48-50 (inserting through an incision in the patient's skin the sheath with the tunneler disposed therein)) through an intercostal space within the patient (Fig. 13 & 15 – shows the patient’s ribs and a plurality of intercostal nerve bundles, as well as the electrical lead 70 being implanted); and
a plurality of electrodes carried on a distal portion of the lead (col. 5, lines 4-5 (distal portion comprises a plurality of electrodes), Fig. 2, element 16 – plurality of electrodes),
wherein at least a subset of electrodes of the plurality of electrodes is configured to at least deliver electrical therapy to a heart of the patient or sense cardiac activity (col. 2, lines 15-17 (an electromagnetic field is applied to the plurality of intercostal nerve bundles after the surgery)).
Ahmad does not wherein the distal portion of the lead is configured to deliver a therapy agent to tissue proximate a ribcage of the patient, and wherein the therapy agent comprises at least one of an anti-inflammatory agent, an analgesic agent, a neurotoxin, or an antimicrobial agent.
Sanghera teaches a cardiac lead (Fig. 1, element 100 – cardiac lead), wherein the distal portion of the lead (para. 0154 (electrode may be configured to couple with distal portion of lead)) is configured to deliver a therapy agent to tissue proximate a ribcage of the patient, and wherein the therapy agent comprises at least one of an anti-inflammatory agent, an analgesic agent, a neurotoxin, or an antimicrobial agent. (para. 0159 ([distal portion of the lead] are well-suited for implantation near and/or along a patient's sternum), 0157 (an anti-inflammatory agent may be incorporated … in hollow area to reduce the patient’s tissue inflammatory response)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ahmad’s distal portion of the elongated structure, to incorporate the therapy agent taught by Sanghera. Doing so reduces the tissue’s inflammatory response from the electrical therapy of the electrodes.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant' s disclosure. Sanghera et al. (US 10022539 B2) is an example of a pulse generator comprising multiple leads within the intercostal space. Vachon et al. (US 5447533) is an example of a pacing lead delivering an anti-inflammatory drug within the distal portion. Teague et al. (US 20230381496 A1) is an example of an implantable lead with a shield coupled to the electrodes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EILEEN ROBLES whose telephone number is (571)429-9383. The examiner can normally be reached Monday-Friday: 8:00 - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EILEEN ROBLES/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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