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 .
Priority
The Applicant claimed the following domestic priority benefits in the Application Data Sheet filed on 5/30/2024: CON of 18/358,961, CIP of 17/453,490, CIP of 17/478,979, CON of 17/463,327, CON of 17/206,359, CON of PCT/IB/2021/052251, and CON of 17/153,875.
The Applicant did not claim any priority in the specification. According to the most recent filing receipt filed on 7/11/2024, no domestic benefits are claimed. Furthermore, the publication of the present application (U.S. PGPub No. 2025/0367455) has no priority claims listed. For examination purposes in this office action, the effective filing date of the present application is 5/30/2024.
This application discloses and claims only subject matter disclosed in the prior applications listed above, and names the inventor or at least one joint inventor named in the prior application. Accordingly, this application may constitute a continuation or divisional. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Election/Restrictions
Claims 17-19 and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 3/31/2026. The Applicant did not elect claim 12, yet elected claims 13-16 (which depend on claim 12). For examination purposes in this office action, it was assumed the Applicant meant to elect claims 12-16.
Information Disclosure Statement
The information disclosure statement filed on 6/06/2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because it includes incorrect patent publication numbers on a substantial number of references. All of the Pre-grant Publications are omitting one digit. Often it was “0” after the first 4 digits that was omitted. With the IDS having over 100 references with incorrect numbers, it was too burdensome for the examiner to correct. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference signs mentioned in the description: 10, 16, 18, 101, 102, 103, and 2010. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference characters not mentioned in the description: 304, 600, 616, 618, 624, and 2210. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference characters in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “101” has been used to designate both an atrial extrusion frame and a distal radio-opaque lead wire. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “102” has been used to designate both atrium lead conduits (lumens) and ventricle lead wires. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “103” has been used to designate both a central axial conduit (lumen) and ventricle lead wires. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because Figures 32-35 are out of order. Currently, Figures 32-35 follow Figure 11. It is recommended that the Applicant correct the order of the drawings, so that Figures 32-35 follow Figure 31. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-37 and 39-41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention. Claim 1 recites an “electrode system connectable to a pacemaker for synchronously pacing both the atrium and ventricle of a human heart.” The specification provides no written description of how both the atrium and ventricle are paced synchronously. It is unclear if pacing shocks are being delivered to the atrium and ventricle at the same moment in time, or if “synchronously” is referring to the overall coordination of contraction of the atrium and ventricle. AV synchronous pacing works by providing a pacing signal to contract the atrium, waiting for a delay to allow the atrium to empty completely into the ventricles, and then providing a pacing signal to contract the ventricle. For examination purposes, “synchronously pacing both the atrium and ventricle of a human heart” is being interpreted as providing AV synchronous pacing to a human heart.
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 1-41 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 atrium and ventricle" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the ventricle wall" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the atrium wall" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the atrial sheath" in line 3. There is insufficient antecedent basis for this limitation in the claim.
The term “about” in claims 5-8 and 38 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the shape of the atrium leads, the shape of the ventricle leads, the atrium leads length, the ventricle leads length, and the steerable catheter sheath diameter are not defined, and thus the scope of the claims is unclear.
Claim 12 recites the limitation "the ventricular sheath" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 is 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. There seem to be multiple limitations that are combined together, and it is unclear as to what the Applicant is trying to claim in claim 12. It is recommended that “an extension hub, the atrial sheath…” should read “an extension hub; the atrial sheath…” instead.
Claim 35 recites the limitation "the “dual chamber” mode" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 38 recites the limitation "the ventricle" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 39 recites the limitation "the catheter sheath" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 39 recites the limitation "the outer catheter sheath" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 39 recites the limitation "the operation" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-37 and 39-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-40 of U.S. Patent No. 12,151,099. Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose an electrode system connectable to a pacemaker for synchronously pacing both the atrium and ventricle of a human heart comprising: a plurality of insulated electrical leads comprising a first set of ventricle leads and a second set of atrium leads, each said lead having an insulated wire and an atraumatic tip, said atraumatic tip comprising a domed head connected to a cylindrical sidewall, said cylindrical sidewall having a proximal edge connected to a coupling, said coupling forming a transition to an outer diameter of the insulated wire, each of the ventricle leads having a resiliency and shape to be deployed in contact with the ventricle wall, each of the atrium leads having the resiliency and shape to be deployed in contact with the atrium wall, wherein the ventricle leads are not attachable to the ventricle wall, but are adapted to contact the ventricle wall, and the atrium leads are not attachable to the atrium wall, but are adapted to contact the atrium wall.
Claims 1-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,638,818. Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose an electrode system connectable to a pacemaker for pacing both the atrium and ventricle of a human heart comprising: a plurality of insulated electrical leads comprising a first set of ventricle leads and a second set of atrium leads, each said lead having an insulated wire and a tip portion, an outer steerable catheter sheath being retractable from the ventricle leads to deploy the ventricle leads in the ventricle, each of the ventricle leads having a resiliency and shape to be deployed in contact with the ventricle wall, each of the atrium leads having the resiliency and shape to be deployed in contact with the atrium wall, wherein the ventricle leads are not attachable to the ventricle wall, but are adapted to contact the ventricle wall, and the atrium leads are not attachable to the atrium wall, but are adapted to contact the atrium wall.
Claims 1-37 and 39-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,957,900. Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose an electrode system connectable to a pacemaker for pacing both the atrium and ventricle of a human heart comprising: a plurality of insulated electrical leads comprising a first set of ventricle leads and a second set of atrium leads, each said lead having an insulated wire and a tip portion, an outer steerable catheter sheath being retractable from the ventricle leads to deploy the ventricle leads in the ventricle, each of the ventricle leads having a resiliency and shape to be deployed in contact with the ventricle wall, each of the atrium leads having the resiliency and shape to be deployed in contact with the atrium wall, wherein the ventricle leads are not attachable to the ventricle wall, but are adapted to contact the ventricle wall, and the atrium leads are not attachable to the atrium wall, but are adapted to contact the atrium wall.
Claims 1-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-53 of U.S. Patent No. 11,980,756. Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose an electrode system connectable to a pacemaker for synchronously pacing both the atrium and ventricle of a human heart comprising: a plurality of insulated electrical leads comprising a first set of ventricle leads and a second set of atrium leads, each said lead having an insulated wire and an atraumatic tip, said atraumatic tip comprising a domed head connected to a cylindrical sidewall (“blunt, rounded” end see claim 2), each of the ventricle leads having a resiliency and shape to be deployed in contact with the ventricle wall, each of the atrium leads having the resiliency and shape to be deployed in contact with the atrium wall, wherein the ventricle leads are not attachable to the ventricle wall, but are adapted to contact the ventricle wall, and the atrium leads are not attachable to the atrium wall, but are adapted to contact the atrium wall.
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.
Claims 1, 3-11, 24-30, 33-35, and 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over Avellanet et al. (U.S. Patent No. 7,957,819) in view of Daniels et al. (U.S. Patent No. 11,420,046) and Eigler et al. (U.S. Patent No. 8,142,363).
Regarding claim 1, Avellanet teaches an electrode system (Col. 4, lines 4-5) connectable to a pacemaker (Fig. 1, Col. 3, line 57, 14) for synchronously pacing both the atrium and ventricle of a human heart comprising (Col. 4, lines 5-7): a plurality of insulated electrical leads (Col. 3, lines 60-61) comprising a first set of ventricle leads (Fig. 1, Col. 3, lines 61-62, 20) and a second set of atrium leads (Fig. 1, Col. 3, lines 62-63, 30), each said lead having an insulated wire (Col. 3, lines 9-11), each of the ventricle leads having a resiliency (Col. 4, lines 11-12) and shape (Col. 4, lines 16-23) to be deployed in contact with the ventricle wall (Col. 3, lines 65-67), each of the atrium leads having the resiliency (Col. 4, lines 11-12) and shape (Col. 4, lines 23-30) to be deployed in contact with the atrium wall (Col. 4, lines 1-2), wherein the ventricle leads are not attachable to the ventricle wall, but are adapted contact the ventricle wall (Col. 4, lines 52-55), and the atrium leads are not attachable to the atrium wall, but are adapted to contact the atrium wall (Col. 4, lines 60-63).
Avellanet does not teach that each lead has an atraumatic tip, wherein each atraumatic tip comprises a domed head connected to a cylindrical sidewall, said cylindrical sidewall having a proximal edge connected to a coupling, said coupling forming a transition to an outer diameter of the insulated wire.
Daniels, however, teaches a pacing guidewire (Fig. 2, Col. 6, lines 24-25, 248) that is connectable to a pacemaker (Fig. 2, Col. 6, lines 63-66, 242) and provides electrical stimuli to a part of the heart, such as the left ventricle (Col. 6, lines 27-28). Daniels teaches that the guidewire comprises an elongate body (Fig. 2, Col. 6, line 25, 250) that has an atraumatic (Col. 10, lines 26-27) distal end (Fig. 9-14, Col. 10, lines 4-5), where the atraumatic distal end comprises a domed head connected to a cylindrical sidewall (See Annotated Fig. 12).
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Annotated Fig. 12 (Daniels)
Eigler, however, teaches a cardiac rhythm management lead (Fig. 3, Col. 9, lines 21-22, 202) that includes an atraumatic tip (Col. 13, lines 23-25, 284) with a domed head connected to a cylindrical sidewall (See Annotated Fig. 4). Eigler further teaches that the cylindrical sidewall has a proximal edge connected to a coupling (Fig. 4, Col. 10, line 2, 234), said coupling forming a transition to an outer diameter of the insulated wire (Fig. 4, Col. 10, line 4, 204) (See Annotated Fig. 4).
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Annotated Fig. 4 (Eigler)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Avellanet to incorporate the teachings of Daniels and Eigler to include that each lead has an atraumatic tip, wherein each atraumatic tip comprises a domed head connected to a cylindrical sidewall, and each cylindrical sidewall has a proximal edge connected to a coupling that forms a transition to an outer diameter of the insulated wire. Doing so would ensure that the distal end of the lead has enhanced flexibility and low tip stiffness, so as to not damage or cause trauma to the endocardium, as recognized by Daniels (Col. 10, lines 24-31) and Eigler (Col. 13, lines 23-25).
Regarding claim 3, Avellanet in view of Daniels and Eigler discloses the claimed invention of claim 1. Avellanet further discloses the electrode system (Col. 4, lines 4-5) according to claim 1, wherein the first set comprises three ventricle leads (Fig. 1, Col. 3, lines 61-62, 20) and the second set comprises four atrium leads (Fig. 1, Col. 3, lines 62-63, 30).
Regarding claim 4, Avellanet teaches the electrode system (Col. 4, lines 4-5) of claim 1. Avellanet does not teach that the atraumatic tip includes a metal portion comprised of stainless steel, nickel-titanium alloy, gold, platinum, or iridium.
Daniels, however, teaches a pacing guidewire (Fig. 2, Col. 6, lines 24-25, 248) that is connectable to a pacemaker (Fig. 2, Col. 6, lines 63-66, 242) and provides electrical stimuli to a part of the heart (Col. 6, lines 27-28). Daniels teaches that the guidewire comprises an atraumatic (Col. 10, lines 26-27) distal end (Fig. 9-14, Col. 10, lines 4-5) that is made of nickel-titanium alloy (Col. 10, lines 32-35), and contains electrodes at the end made of platinum or iridium (Col. 12, lines 4-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Avellanet to incorporate the teachings of Daniels to include that the atraumatic tip includes a metal portion comprised of stainless steel, nickel-titanium alloy, gold, platinum, or iridium. Doing so would improve the resistance to polarization of the atraumatic tip and decrease the stimulation threshold (Col. 12, lines 7-8), as recognized by Daniels.
Regarding claim 5, Avellanet teaches the electrode system (Col. 4, lines 4-5) according to claim 1, wherein the atrium leads (Fig. 1, Col. 3, lines 62-63, 30) are the same length or different staggered lengths (Col. 4, lines 23-28 and 38-39), and have a pre-set curved shape (Col. 4, lines 23-24).
Avellanet discloses the claimed invention except for that the atrium leads extend about 2.00 inches from a central axis of the atrial sheath. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the dimension in which the atrium leads extend from a central axis of the atrial sheath, since it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984.) See the MPEP 2144.04. Furthermore, such a modification would provide the predictable results of optimizing implantation and treatment protocols to meet specific patient therapeutic needs and requirements.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality of the dimension in which the atrium leads extend from a central axis of the atrial sheath (See Paragraph 91 of Applicant’s Specification), this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claim 6, Avellanet teaches the electrode system (Col. 4, lines 4-5) according to claim 1, wherein the ventricle leads (Fig. 1, Col. 3, lines 61-62, 20) comprise a straight distal ventricle lead and two pre-set curved shape (Col. 4, lines 12-13) ventricle leads (See Annotated Fig. 1), the ventricle leads are the same length or different staggered lengths (Col. 4, lines 16-17), the straight distal ventricle lead extending along a central axis of the atrial sheath (See Annotated Fig. 1).
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Annotated Fig. 1 (Avellanet)
Avellanet discloses the claimed invention except for that the ventricle leads extend about 1.50 inches from a central axis of the atrial sheath. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the dimension in which the ventricle leads extend from a central axis of the atrial sheath, since it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984.) See the MPEP 2144.04. Furthermore, such a modification would provide the predictable results of optimizing implantation and treatment protocols to meet specific patient therapeutic needs and requirements.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality of the dimension in which the ventricle leads extend from a central axis of the atrial sheath (See Paragraph 92 of Applicant’s Specification), this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claim 7, Avellanet teaches the electrode system (Col. 4, lines 4-5) according to claim 1, wherein the atrium leads (Fig. 1, Col. 3, lines 62-63, 30) have a pre-set length (Col. 4, lines 23-28 and 38-39) and a pre-set curved shape (Col. 4, lines 23-24).
Avellanet teaches the claimed invention except for that the atrium leads have a length of about 3.14 inches (1/2C=pi/2*D). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include that the atrium leads have a length of about 3.14 inches, 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 [ or optimum value ] involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A.
Avellanet also discloses the claimed invention except for that the atrium leads extend about 2.00 inches from a central axis of the atrial sheath. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the dimension in which the atrium leads extend from a central axis of the atrial sheath, since it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984.) See the MPEP 2144.04. Furthermore, such a modification would provide the predictable results of optimizing implantation and treatment protocols to meet specific patient therapeutic needs and requirements.
Since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality of the length of the atrium leads and dimension in which the atrium leads extend from a central axis of the atrial sheath (See Paragraphs 91 and 93 of Applicant’s Specification), this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claim 8, Avellanet teaches the electrode system (Col. 4, lines 4-5) according to claim 1, wherein the ventricle leads (Fig. 1, Col. 3, lines 61-62, 20) comprise a distal ventricle lead and two pre-set curved shape ventricle leads (See Annotated Fig. 1 of Avellanet Above).
Avellanet teaches the claimed invention except for that the distal ventricle leads have a length of about 2.76+/-0.20 inches, and that the two pre-set curved shape ventricle leads have a length of about 2.355 inches (1/2C=pi/2*D). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include that the distal ventricle lead has a length of about 2.76+/-0.20 inches, and that the two curved ventricle leads have a length of about 2.355 inches, 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 [ or optimum value ] involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A.
Avellanet also discloses the claimed invention except for that the two curved ventricle leads extend about 1.50 inches from a central axis of the atrial sheath. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the dimension in which the two curved ventricle leads extend from a central axis of the atrial sheath, since it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984.) See the MPEP 2144.04. Furthermore, such a modification would provide the predictable results of optimizing implantation and treatment protocols to meet specific patient therapeutic needs and requirements.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality of the length of the distal lead and two curved ventricle leads and dimension in which the two curved ventricle leads extend from a central axis of the atrial sheath (See Paragraphs 92 and 94 of Applicant’s Specification), this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claim 9, Avellanet teaches the electrode system (Col. 4, lines 4-5) according to claim 1, wherein when deployed in the ventricle (Fig. 1), one of said ventricle leads is a distal ventricle lead extending along a central axis of the atrial sheath (See Annotated Fig. 1 of Avellanet Above), and two ventricle leads (See Annotated Fig. 1 of Avellanet Above) are memory shape-set (Col. 2, lines 62-63).
Avellanet discloses the claimed invention except for that the two curved ventricle leads are at 90 degrees to the central axis and are offset 180 degrees from each other in a plane perpendicular to the distal ventricle lead. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the angles in which the two curved ventricle leads are oriented, since it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984.) See the MPEP 2144.04. Furthermore, such a modification would provide the predictable results of optimizing implantation and treatment protocols to meet specific patient therapeutic needs and requirements.
Regarding claim 10, Avellanet teaches the electrode system (Col. 4, lines 4-5) according to claim 1, wherein when the atrium leads (Fig. 1, Col. 3, lines 62-63, 30) are deployed in the atrium (Fig. 1), the atrium leads are memory shape-set (Col. 2, lines 62-63).
Avellanet discloses the claimed invention except for that the atrium leads are at 90 degrees to the central axis and are offset 90 degrees from each other in a plane perpendicular to the central axis. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the angles in which the atrium leads are oriented, since it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984.) See the MPEP 2144.04. Furthermore, such a modification would provide the predictable results of optimizing implantation and treatment protocols to meet specific patient therapeutic needs and requirements.
Regarding claim 11, Avellanet in view of Daniels and Eigler discloses the claimed invention of claim 1. Avellanet further discloses the electrode system (Col. 4, lines 4-5) according to claim 1, where the atrium leads (Fig. 1, Col. 3, lines 62-63, 30) and the ventricular leads (Fig. 1, Col. 3, lines 61-62, 20) have different lengths (Col. 4, lines 38-39).
Regarding claim 24, Avellanet teaches the electrode system (Col. 4, lines 4-5) of claim 1 that includes the atrium leads (Fig. 1, Col. 3, lines 62-63, 30) and the ventricle leads (Fig. 1, Col. 3, lines 61-62, 20). Avellanet does not teach that the atraumatic tip of the atrium leads and the ventricle leads are the same size or different.
Daniels, however, teaches a pacing guidewire (Fig. 2, Col. 6, lines 24-25, 248) that is connectable to a pacemaker (Fig. 2, Col. 6, lines 63-66, 242) and provides electrical stimuli to a part of the heart (Col. 6, lines 27-28). Daniels teaches that the guidewire comprises an atraumatic (Col. 10, lines 26-27) distal end (Fig. 9-14, Col. 10, lines 4-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Avellanet to incorporate the teachings of Daniels to include that each lead has an atraumatic tip. Doing so would ensure that the distal end of the lead has enhanced flexibility and low tip stiffness (Col. 10, lines 24-31), so as to not damage or cause trauma to the endocardium, as recognized by Daniels.
Avellanet in view of Daniels discloses the claimed invention except for that the atraumatic tip of the atrium leads and ventricle leads are the same size or different. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the size of the atraumatic tip of the atrium leads and ventricle leads, since it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984.) See the MPEP 2144.04. Furthermore, such a modification would provide the predictable results of optimizing implantation and treatment protocols to meet specific patient therapeutic needs and requirements.
Regarding claim 25, Avellanet teaches the electrode system (Col. 4, lines 4-5) according to claim 1 that includes the atrium leads (Fig. 1, Col. 3, lines 62-63, 30). Avellanet does not teach that the atrium leads each have an atraumatic tip with an outer diameter of 8 FR (8 x 0.33 mm = 2.64 mm or 0.1039 in).
Daniels, however, teaches a pacing guidewire (Fig. 2, Col. 6, lines 24-25, 248) that is connectable to a pacemaker (Fig. 2, Col. 6, lines 63-66, 242) and provides electrical stimuli to a part of the heart, such as the left ventricle (Col. 6, lines 27-28). Daniels teaches that the guidewire comprises an elongate body (Fig. 2, Col. 6, line 25, 250) that has an atraumatic (Col. 10, lines 26-27) distal end (Fig. 9-14, Col. 10, lines 4-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Avellanet to incorporate the teachings of Daniels to include that each lead has an atraumatic tip. Doing so would ensure that the distal end of the lead has enhanced flexibility and low tip stiffness (Col. 10, lines 24-31), so as to not damage or cause trauma to the endocardium, as recognized by Daniels.
Avellanet in view of Daniels and Eigler teaches the claimed invention except for that the atrium leads each have an atraumatic tip with an outer diameter of 8 FR (8 x 0.33 mm = 2.64 mm or 0.1039 in). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include that the outer diameter is 8 FR (8 x 0.33 mm = 2.64 mm or 0.1039 in), 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 [ or optimum value ] involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A. Furthermore, such a modification would provide the predictable results of optimizing implantation and treatment protocols to meet specific patient therapeutic needs and requirements.
Regarding claim 26, Avellanet teaches the electrode system (Col. 4, lines 4-5) of claim 1 that includes three ventricle leads (Fig. 1, Col. 3, lines 61-62, 20) that can be different lengths (Col. 4, lines 16-17). Avellanet does not teach that at least two of the ventricle leads each have an atraumatic tip with an outer diameter of 8 FR (8 x 0.33 mm = 2.64 mm or 0.1039 in).
Daniels, however, teaches a pacing guidewire (Fig. 2, Col. 6, lines 24-25, 248) that is connectable to a pacemaker (Fig. 2, Col. 6, lines 63-66, 242) and provides electrical stimuli to a part of the heart, such as the left ventricle (Col. 6, lines 27-28). Daniels teaches that the guidewire comprises an elongate body (Fig. 2, Col. 6, line 25, 250) that has an atraumatic (Col. 10, lines 26-27) distal end (Fig. 9-14, Col. 10, lines 4-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Avellanet to incorporate the teachings of Daniels to include that each lead has an atraumatic tip. Doing so would ensure that the distal end of the lead has enhanced flexibility and low tip stiffness (Col. 10, lines 24-31), so as to not damage or cause trauma to the endocardium, as recognized by Daniels.
Avellanet in view of Daniels and Eigler teaches the claimed invention except for that at least two of the ventricle leads each have an atraumatic tip with an outer diameter of 8 FR (8 x 0.33 mm = 2.64 mm or 0.1039 in). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include that the outer diameter is 8 FR (8 x 0.33 mm = 2.64 mm or 0.1039 in), 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 [ or optimum value ] involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A. Furthermore, such a modification would provide the predictable results of optimizing implantation and treatment protocols to meet specific patient therapeutic needs and requirements.
Regarding claim 27, Avellanet teaches the electrode system (Col. 4, lines 4-5) of claim 1 that includes three ventricle leads (Fig. 1, Col. 3, lines 61-62, 20) that can be different lengths (Col. 4, lines 16-17). Avellanet does not teach that one of the ventricle leads is a distal ventricle lead (See Annotated Fig. 1 of Avellanet Above) and has an atraumatic tip with an outer diameter of 11 FR (11 x 0.33 mm = 3.63 mm or 0.1429 in).
Daniels, however, teaches a pacing guidewire (Fig. 2, Col. 6, lines 24-25, 248) that is connectable to a pacemaker (Fig. 2, Col. 6, lines 63-66, 242) and provides electrical stimuli to a part of the heart, such as the left ventricle (Col. 6, lines 27-28). Daniels teaches that the guidewire comprises an elongate body (Fig. 2, Col. 6, line 25, 250) that has an atraumatic (Col. 10, lines 26-27) distal end (Fig. 9-14, Col. 10, lines 4-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Avellanet to incorporate the teachings of Daniels to include that each lead has an atraumatic tip. Doing so would ensure that the distal end of the lead has enhanced flexibility and low tip stiffness (Col. 10, lines 24-31), so as to not damage or cause trauma to the endocardium, as recognized by Daniels.
Avellanet in view of Daniels and Eigler teaches the claimed invention except for one of the ventricle leads has an atraumatic tip with an outer diameter of 11 FR (11 x 0.33 mm = 3.63 mm or 0.1429 in). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include that the outer diameter is 11 FR (11 x 0.33 mm = 3.63 mm or 0.1429 in), 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 [ or optimum value ] involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A. Furthermore, such a modification would provide the predictable results of optimizing implantation and treatment protocols to meet specific patient therapeutic needs and requirements.
Regarding claim 28, Avellanet teaches the electrode system (Col. 4, lines 4-5) of claim 1, wherein each lead (Col. 3, lines 60-61) has an insulated wire (Col. 3, lines 9-11). Avellanet does not teach that the insulated wire has a fibrin-resistant coat along at least a part thereof, the fibrin-resistant coat comprised of parylene, silicone, siloxane, PEEK, PET, PFTE, or parylene co-polymer doped with a releasable anti-coagulant drug or anti-inflammatory drug.
Daniels, however, teaches a pacing guidewire (Fig. 2, Col. 6, lines 24-25, 248) that is connectable to a pacemaker (Fig. 2, Col. 6, lines 63-66, 242) and provides electrical stimuli to a part of the heart, such as the left ventricle (Col. 6, lines 27-28). Daniels teaches that the guidewire comprises an elongate body (Fig. 2, Col. 6, line 25, 250) that is insulated (Col. 7, line 2). Daniels also teaches that part of the elongate body (Col. 6, lines 28-29) has a fibrin-resistant coating that can include silicone (Col. 6, line 31) or PTFE (Col. 6, lines 30-31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Avellanet to incorporate the teachings of Daniels to include that the insulated wire has a fibrin-resistant coat along at least a part thereof that comprises silicon or PTFE. Doing so would ensure that the wire is able to easily move through a guide catheter and ease delivery of the leads (Col. 6, lines 31-33), as recognized by Daniels.
Although Daniels does not explicitly disclose that the hydrophilic coating is fibrin-resistant, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ a fibrin-resistant coating on at least a part of the insulated wire in order to provide the predictable results of limiting fibrin accumulation and blood clot formation on the insulated wire. Furthermore, silicone and PTFE coatings are well known in the implantable device arts to ensure that fibrin build-up does not occur.
Regarding claim 29, Avellanet teaches the electrode system (Col. 4, lines 4-5) according to claim 1, wherein each of said electrical leads (Col. 3, lines 60-61) has a distal portion made from a shape memory material (Col. 4, lines 11-12 and Col. 6, lines 33-35). Avellanet does not teach that each of said electrical leads has a proximal portion made from wire with a radio-opaque material.
Daniels, however, teaches a pacing guidewire (Fig. 2, Col. 6, lines 24-25, 248) that is connectable to a pacemaker (Fig. 2, Col. 6, lines 63-66, 242) and provides electrical stimuli to a part of the heart, such as the left ventricle (Col. 6, lines 27-28). Daniels teaches that the guidewire comprises an elongate body (Fig. 2, Col. 6, line 25, 250) with helical coils, where a portion of the helical coils can be applied with a radiopaque surface treatment (Col. 11, lines 26-29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Avellanet to incorporate the teachings of Daniels to include that each of said electrical leads has a proximal portion made from wire with a radio-opaque material. Doing so would ensure that the leads can be highly visible under fluoroscopy (Col. 11, lines 30-31) in order to ensure the leads are properly implanted and reach their intended location, as recognized by Daniels. Furthermore, fluoroscopy imaging is well known in the implantable device arts to ensure that medical devices are properly implanted.
Regarding claim 30, Avellanet teaches the electrode system (Col. 4, lines 4-5) according to claim 1. Avellanet does not teach that each of said atraumatic tips has a radio-opaque material.
Daniels, however, teaches a pacing guidewire (Fig. 2, Col. 6, lines 24-25, 248) that is connectable to a pacemaker (Fig. 2, Col. 6, lines 63-66, 242) and provides electrical stimuli to a part of the heart, such as the left ventricle (Col. 6, lines 27-28). Daniels teaches that the guidewire comprises an elongate body (Fig. 2, Col. 6, line 25, 250) that has an atraumatic (Col. 10, lines 26-27) distal end (Fig. 9-14, Col. 10, lines 4-5). Daniels also teaches that the atraumatic distal end can be made of a radiopaque material (Col. 12, lines 8-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Avellanet to incorporate the teachings of Daniels to include that each of said atraumatic tips has a radio-opaque material. Doing so would ensure that the atraumatic tips can be highly visible under fluoroscopy (Col. 12, lines 9-10) in order to ensure the leads are properly implanted and reach their intended location, as recognized by Daniels. Furthermore, fluoroscopy imaging is well known in the implantable device arts to ensure that medical devices are properly implanted.
Regarding claim 33, Avellanet in view of Daniels and Eigler discloses the claimed invention of claim 1. Avellanet further discloses the electrode system (Col. 4, lines 4-5) according to claim 1, wherein the atrium leads (Fig. 1, Col. 3, lines 62-63, 30) are memory shape-set (Col. 4, lines 11-12 and Col. 6, lines 33-35) to sense and stimulate (Col. 3, lines 34-37) an atrial endothelium area of the heart (Col. 4, lines 60-63), the ventricle leads (Fig. 1, Col. 3, lines 61-62, 20) are memory shape set (Col. 4, lines 11-12 and Col. 6, lines 33-35) to sense and stimulate (Col. 4, lines 49-51) a ventricular endothelium area of the heart (Col. 4, lines 52-56).
Regarding claim 34, Avellanet in view of Daniels and Eigler discloses the claimed invention of claim 1. Avellanet further discloses the electrode system (Col. 4, lines 4-5) according to claim 1, wherein each of said ventricle leads (Fig. 1, Col. 3, lines 61-62, 20) is connected to a ventricular sensor or stimulator in a pacemaker (Col. 4, lines 31-37) and each of said atrium leads (Fig. 1, Col. 3, lines 62-63, 30) is connected to an atrium sensor or stimulator in said pacemaker (Col. 4, lines 31-37).
Regarding claim 35, Avellanet in view of Daniels and Eigler discloses the claimed invention of claim 1. Avellanet further discloses the electrode system (Col. 4, lines 4-5) according to claim 1, wherein the electrical leads (Col. 3, lines 60-61) are connected to a pacemaker (Fig. 1, Col. 3, line 57, 14) that includes two sequential pulse generators (Fig. 1, Col. 4, lines 32-34, 16/18) to provide sensing and stimuli for a ventricle and for an atrium (Col. 4, line 67 and Col. 5, line 1) for sequentially pacing both the atrium and ventricle of a heart (Col. 4, lines 35-36) in the "dual chamber" mode (Col. 4, lines 64-67).
Regarding claim 39, Avellanet teaches a method for quickly deploying a cardiac pacing device to a heart in a patient (Col. 2, lines 48-61), comprising: (i) providing the system (Col. 4, lines 4-5) in claim 1; (ii) accessing a jugular vein in the patient and advancing the catheter sheath to a right ventricle of the heart of the patient (Col. 2, lines 55-61); (iii) Withdrawing the outer catheter sheath to a first position to deploy the first set of three ventricle leads (Col. 4, lines 52-56); (iv) Withdrawing the outer catheter sheath to a second position to deploy the second set of four atrium leads (Col. 4, lines 60-63); (vi) Performing a cardiac pacing routine appropriate as a treatment for the patient cardiac pattern using the system (Col. 4, lines 64-67 and Col. 5, lines 1-7).
Avellanet does not teach that the method includes the step of performing a diagnostic test using the first set of three ventricle leads and the second set of four atrium leads to identify patient cardiac patterns and to validate the operation of the system.
Daniels, however, teaches a pacing guidewire (Fig. 2, Col. 6, lines 24-25, 248) that is connectable to a pacemaker (Fig. 2, Col. 6, lines 63-66, 242) and provides electrical stimuli to a part of the heart, such as the left ventricle (Col. 6, lines 27-28). Daniels also teaches that diagnostic tests are able to be performed immediately following guidewire placement in order to identify cardiac patterns and validate the operation of the system (Col. 17, lines 11-15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Avellanet to incorporate the teachings of Daniels to include that diagnostic testing is performed to identify patient cardiac patterns and validate the operation of the system. Doing so would ensure the system can deliver the minimum amount of electrical energy to consistently trigger a heartbeat (Col. 17, line 14), as recognized by Daniels.
Avellanet also does not explicitly disclose the catheter sheath under ultrasound or other non-fluoroscopic imaging modality. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ an imaging modality, such as ultrasound or other non-fluoroscopic imaging, in order to provide the predictable results of ensuring the leads are properly implanted and reach their intended target location. Furthermore, ultrasound or other non-fluoroscopic imaging techniques are well known in the implantable device arts to ensure that medical devices are properly implanted.
Regarding claim 40, Avellanet in view of Daniels and Eigler discloses the invention substantially as claimed, but is silent as to how long the steps (i)-(iv) are performed. 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 time period for performing the deployment steps in a time period no longer than 3-5 minutes, 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 [ or optimum value ] involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A. Furthermore, such a modification would provide the predictable results of optimizing implantation and treatment protocols to meet specific patient therapeutic needs and requirements.
Regarding claim 41, Avellanet in view of Daniels and Eigler discloses the invention substantially as claimed, but is silent as to how long the system is deployed in a patient. 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 time period for how long the system is deployed in a patient to a time period from 1 hour up to 7 days of use, 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 [ or optimum value ] involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05-II-A. Furthermore, such a modification would provide the predictable results of optimizing implantation and treatment protocols to meet specific patient therapeutic needs and requirements.
Claims 12, 14, 16, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Avellanet et al. (U.S. Patent No. 7,957,819) in view of Daniels et al. (U.S. Patent No. 11,420,046) and Eigler et al. (U.S. Patent No. 8,142,363) as applied to claim 1 above, and further in view of Marin y Kall et al. (U.S. PGPub No. 2022/0226642).
Regarding claim 12, Avellanet teaches the electrode system (Col. 4, lines 4-5)
according to claim 1. Avellanet does not teach that electrode system has a steerable delivery catheter with a female Luer connector, a side-port Tuohy Borst access connector, a deployment stopper, a terminal connection connected to the electrical leads, and an extension hub, the atrial sheath disposed within the steerable delivery catheter, the ventricular sheath disposed within the atrial sheath.
Marin y Kall, however, teaches an electrode system (Paragraph 0125, line 2) with a steerable delivery catheter (Fig. 9A-9C, Paragraph 0146, lines 8-9) with a female Luer connector (Fig. 9A-9C, Paragraph 0146, line 4, 903), a side-port Tuohy Borst access connector (Fig. 1, Paragraph 0115, line 2, 115), a deployment stopper (Fig. 1, Paragraph 0115, lines 4-5, 117), a terminal connection connected to electrical leads (Fig. 2, Paragraph 0120, line 4, 119), and an extension hub (Fig. 1, Paragraph 0115, line 1, 114). Marin y Kall further teaches that an atrial sheath (Fig. 21, Paragraph 0158, line 9, 2102) is disposed within the steerable delivery catheter (Fig. 21, Paragraph 0158, lines 8-9), and a ventricular sheath (Fig. 21, Paragraph 0158, line 10, 2103) is disposed within the atrial sheath (Paragraph 0161, lines 1-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Avellanet to incorporate the teachings of Marin y Kall to include that the system has a steerable delivery catheter with a female Luer connector, a side-port Tuohy Borst access connector, a deployment stopper, a terminal connection connected to the electrical leads, and an extension hub, the atrial sheath disposed within the steerable delivery catheter, the ventricular sheath disposed within the atrial sheath. Doing so would ensure that the plurality of leads do not get tangled during installation and are positioned correctly (Paragraph 0160, lines 13-14), as recognized by Marin y Kall.
Regarding claim 14, Avellanet in view of Daniels, Eigler, and Marin y Kall discloses the claimed invention except for that the steerable delivery catheter has an outer diameter (OD) of 0.104 +/-0.003 inches, an inner diameter (ID) of 0.090 +/- 0.002 inches, and a working length of 12.00 +/- 0.30 inches. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the dimensions of the steerable delivery catheter, since it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984.) See the MPEP 2144.04. Furthermore, such a modification would provide the predictable results of optimizing implantation and treatment protocols to meet specific patient therapeutic needs and requirements.
Regarding claim 16, Avellanet teaches the electrode system (Col. 4, lines 4-5)
according to claim 12. Avellanet does not teach that the steerable delivery catheter has a dead-stop marker to indicate a maximum safe distance of insertion of the electrical leads.
Marin y Kall, however, teaches an electrode system (Paragraph 0125, line 2) with a steerable delivery catheter (Fig. 9A-9C, Paragraph 0146, lines 8-9) with distance markers every 10 cm along its entire length (Paragraph 0067, lines 41-43).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Avellanet to incorporate the teachings of Marin y Kall to include that the steerable delivery catheter has a dead-stop marker to indicate a maximum safe distance of insertion of the electrical leads. Doing so would ensure that the healthcare provider is able to visualize how much of the steerable delivery catheter has been inserted into the patient in order to ensure proper and safe implantation (Paragraph 0067, lines 41-43), as recognized by Marin y Kall.
Regarding claim 32, Avellanet teaches the electrode system (Col. 4, lines 4-5) according to claim 1. Avellanet does not teach that the atrium leads and the ventricle leads each connect to lead terminals that extend from a cable junction housing to a pacemaker, wherein the pacemaker comprises computer program instructions readable by a processor to provides functions selected from the group consisting of: a diagnostic function, a sensor operation, a stimulation signal, a program for an individual lead for sensing, a program to reduce over-sensing of the ventricular leads by T-waves or other noise or attenuating or interfering signals, a program to reduce over-sensing of the atrium leads by the R-wave, a program to minimize cross-talk, and a program to adjust sensing and stimulation on a lead-by-lead basis.
Marin y Kall, however, teaches an electrode system (Paragraph 0125, line 2) with a plurality of ventricle leads (Paragraph 0067, line 17) and a plurality of atrium leads (Paragraph 0067, line 19). Marin y Kall also teaches that the atrium leads and the ventricle leads each connect to lead terminals that extend from a cable junction housing to a pacemaker (Paragraph 0067, lines 51-54), wherein the pacemaker comprises computer program instructions readable by a processor to provides functions selected from the group consisting of (Paragraph 0067, lines 54-56): a diagnostic function, a sensor operation, a stimulation signal, a program for an individual lead for sensing, a program to reduce over-sensing of the ventricular leads by T-waves or other noise or attenuating or interfering signals, a program to reduce over-sensing of the atrium leads by the R-wave, a program to minimize cross-talk, and a program to adjust sensing and stimulation on a lead-by- lead basis (Paragraph 0067, lines 56-63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Avellanet to incorporate the teachings of Marin y Kall to include that the atrium and ventricle leads each connect to lead terminals that extend from a cable junction housing to a pacemaker, wherein the pacemaker comprises computer program instructions readable by a processor. Doing so would ensure that over-sensing does not occur, and interference signals are minimized (Paragraph 0067), as recognized by Marin y Kall.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Avellanet et al. (U.S. Patent No. 7,957,819) in view of Daniels et al. (U.S. Patent No. 11,420,046), Eigler et al. (U.S. Patent No. 8,142,363), and Marin y Kall et al. (U.S. PGPub No. 2022/0226642) as applied to claim 12 above, and further in view of Zeus (see PTO 892).
Regarding claim 13, Avellanet in view of Daniels and Marin y Kall discloses the
claimed invention except for that the steerable delivery catheter has an inner polymer liner selected from parylene or PTFE, a Tie layer, a braid, an outer jacket, and a heat shrink fusing sleeve located near a distal tip. Zeus, however, teaches a delivery catheter that has an inner polymer liner made of PTFE, a Tie layer, a braid, an outer jacked, and a heat shrink fusing sleeve located near a distal tip (See Below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Avellanet to incorporate the teachings of Zeus to include that the steerable delivery catheter has an inner polymer liner of PTFE, a Tie layer, a braid, an outer jacket, and a heat shrink fusing sleeve located near a distal tip. Doing so would ensure that adhesion between the liner and outer jacket is improved, as recognized by Zeus.
Claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Avellanet et al. (U.S. Patent No. 7,957,819) in view of Daniels et al. (U.S. Patent No. 11,420,046) and Eigler et al. (U.S. Patent No. 8,142,363) as applied to claim 1 above, and further in view of Min et al. (U.S. PGPub No. 2020/0353266).
Regarding claim 20, Avellanet teaches the electrode system (Col. 4, lines 4-5)
according to claim 1 that includes a plurality of electrical leads (Col. 3, lines 60-61).
Avellanet does not teach that the electrical leads are monopolar, either positive or negative polarity.
Min, however, teaches a system for His bundle pacing that includes a stimulation device (Fig. 1, Paragraph 0046, line 1, 10) and a plurality of electrical leads (Fig. 1, Paragraph 0046, line 3, 20/21/24/30), wherein the stimulation device can be a pacemaker (Paragraph 0049, line 12). Furthermore, Min teaches that the system can include any number of leads that may be monopolar (Paragraph 0045, lines 11-16).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Avellanet to incorporate the teachings of
Min to include that the electrical leads are monopolar. Doing so would improve direction of current and allow a larger area of the endocardium to be stimulated (Paragraph 0049), as recognized by Min.
Regarding claim 21, Avellanet teaches the electrode system (Col. 4, lines 4-5)
according to claim 1 that includes a plurality of electrical leads (Col. 3, lines 60-61). Avellanet does not teach that, when connected to a pacemaker, the distal ventricle lead and a second ventricle lead have a signal of a first polarity, and a third ventricle lead has a signal of an opposite polarity. Min, however, teaches a system for His bundle pacing that can include any number of leads that may be monopolar (Paragraph 0045, lines 11-16). As understood from Min, the ventricle leads can all be monopolar (positive or negative polarity) and can have a variety of polarity combinations.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Avellanet to incorporate the teachings of Min to include that when connected to a pacemaker, the distal ventricle lead and a second ventricle lead have a signal of a first polarity, and a third ventricle lead has a signal of an opposite polarity. Doing so would improve direction of current and allow a larger area of the endocardium to be stimulated (Paragraph 0049), as recognized by Min.
Regarding claim 22, Avellanet teaches the electrode system (Col. 4, lines 4-5)
according to claim 1 that includes a plurality of electrical leads (Col. 3, lines 60-61). Avellanet does not teach that, when connected to a pacemaker, two of the atrium leads have a signal of a first polarity and two of the atrium leads have a signal of an opposite polarity. Min, however, teaches a system for His bundle pacing that can include any number of leads that may be monopolar (Paragraph 0045, lines 11-16). As understood from Min, the ventricle leads can all be monopolar (positive or negative polarity) and can have a variety of polarity combinations.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Avellanet to incorporate the teachings of Min to include that when connected to a pacemaker, two of the atrium leads have a signal of a first polarity and two of the atrium leads have a signal of an opposite polarity. Doing so would improve direction of current and allow a larger area of the endocardium to be stimulated (Paragraph 0049), as recognized by Min.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Avellanet et al. (U.S. Patent No. 7,957,819) in view of Daniels et al. (U.S. Patent No. 11,420,046) and Eigler et al. (U.S. Patent No. 8,142,363) as applied to claim 1 above, and further in view of Dabney et al. (U.S. Patent No. 8,712,544).
Regarding claim 23, Avellanet teaches the electrode system (Col. 4, lines 4-5)
according to claim 1 that includes insulated wire (Col. 3, lines 9-11) for each of the atrium leads (Fig. 1, Col. 3, lines 62-63, 30) and ventricle leads (Fig. 1, Col. 3, lines 61-62, 20). Avellanet does not teach that the insulated wires are radio-opaque, comprised of parylene, PTFE or PTE, and prevent cross-talk.
Daniels, however, teaches a pacing guidewire (Fig. 2, Col. 6, lines 24-25, 248) that is connectable to a pacemaker (Fig. 2, Col. 6, lines 63-66, 242) and provides electrical stimuli to a part of the heart, such as the left ventricle (Col. 6, lines 27-28). Daniels teaches that the guidewire comprises an elongate body (Fig. 2, Col. 6, line 25, 250) that is insulated (Col. 7, line 2). Daniels also teaches that the elongate body can be radiopaque (Col. 11, lines 28-31), can include PTFE (Col. 6, lines 30-31), and can be braided (Col. 7, lines 18-22). The examiner notes that braided wires are commonly known in the electronics arts to cancel out electromagnetic interference and prevent cross-talk.
Dabney, however, teaches an electromagnetic shield for a passive electronic component in an active medical device implantable lead, wherein an exemplary medical device can be a pacemaker (Fig. 1, Col. 12, lines 63-64, 100C). Dabney teaches that a conformal coating can be applied over the electrical attachments to the leads, which can include a parylene coating (Col. 21, lines 1-3). Dabney also teaches that a portion of the lead can have an electromagnetic shield (Col. 11, lines 52-53), which prevents cross-talk.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Avellanet to incorporate the teachings of Daniels and Dabney to include that the insulated wire is radio-opaque, comprised of parylene, PTFE or PTE, and prevents cross-talk. Doing so would ensure that the wire is able to be easily visible under fluoroscopic imaging, that the wire can easily move through a guide catheter and ease delivery of the leads, and that interference signals are limited, as recognized by Daniels (Col. 6-7 and 11) and Dabney (Col. 11 and 21).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Avellanet et al. (U.S. Patent No. 7,957,819) in view of Daniels et al. (U.S. Patent No. 11,420,046) and Eigler et al. (U.S. Patent No. 8,142,363) as applied to claim 35 above, and further in view of An et al. (U.S. PGPub No. 2020/0188677).
Regarding claim 36, Avellanet teaches the electrode system (Col. 4, lines 4-5) according to claim 1. Avellanet does not teach that the pacemaker includes computer program instructions executable by a processor for performing digital signal processing for the ventricle leads and the atrium leads, wherein the digital signal processing is selected from the group consisting of: multiple input, multiple output (MIMO), single input multiple output (SIMO), single input single output (SISO), and multiple input single output (MISO).
An, however, teaches a patient management system (Fig. 1, Paragraph 0048, lines 1-2, 100) for an implantable medical device (Fig. 1, Paragraph 0048, lines 5-6, 110) that is electrically coupled to a heart of a patient (Paragraph 0048, line 6) through a plurality of leads (Fig. 1, Paragraph 0048, line 7, 108A-C). An teaches that the IMD can be a pacemaker (Paragraph 0048, lines 9-10), and that the leads can be placed in both the atrium and ventricle (Paragraph 0050).
Furthermore, An teaches that the pacemaker includes computer program instructions that are executable by a processor (Paragraph 0066, lines 13-14) for performing digital signal processing for the leads (Paragraph 0066, lines 8-9), which can include: single-input multiple output (SIMO), multiple-input multiple-output (MIMO), multiple-input single-output (MISO) (Paragraph 0117, line 21-24).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Avellanet to incorporate the teachings of An to include that processor is able to perform digital signal processing for the multiple leads. Doing so would analyze and enhance signals from the leads, as well as filter out unwanted noise (Paragraph 0117), as recognized by An.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Avellanet et al. (U.S. Patent No. 7,957,819) in view of Daniels et al. (U.S. Patent No. 11,420,046), Eigler et al. (U.S. Patent No. 8,142,363), and An et al. (U.S. PGPub No. 2020/0188677) as applied to claim 36 above, and further in view of Marin y Kall et al. (U.S. PGPub No. 2022/0226642).
Regarding claim 37, Avellanet teaches the electrode system (Col. 4, lines 4-5) according to claim 1. Avellanet does not teach that the computer program instructions that are executable by a processor provides one or more functions selected from: decreasing sensitivity of certain leads and increasing sensitivity of other leads during a depolarization cycle (PQRST) allows the invention to increase SNR in the sensing function, decreasing or increasing stimulatory signals to one or more leads allows the invention to more accurately provide stimulation to the atrial endothelium, ventricular endothelium, or other cardiac tissue to provide a level of granularity to the stimulation function, programming leads so that sensing leads are not required to share the function of a shocking/stimulation leads, and bypassing damaged or degraded leads to allow continued functioning without requiring the entire device to be removed from a patient, this increasing the longevity of implanted devices using the inventive technology.
Marin y Kall, however, teaches an electrode system (Paragraph 0125, line 2) computer program instructions that are executable by a processor provides one or more functions selected from: decreasing sensitivity of certain leads and increasing sensitivity of other leads during a depolarization cycle (PQRST) allows the invention to increase SNR in the sensing function, decreasing or increasing stimulatory signals to one or more leads allows the invention to more accurately provide stimulation to the atrial endothelium, ventricular endothelium, or other cardiac tissue to provide a level of granularity to the stimulation function, programming leads so that sensing leads are not required to share the function of a shocking/stimulation leads, and bypassing damaged or degraded leads to allow continued functioning without requiring the entire device to be removed from a patient, this increasing the longevity of implanted devices using the inventive technology (Paragraph 0081, lines 1-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Avellanet to incorporate the teachings of Marin y Kall to include that the computer program instructions that are executable by a processor provides one or more functions selected from: decreasing sensitivity of certain leads and increasing sensitivity of other leads during a depolarization cycle (PQRST) allows the invention to increase SNR in the sensing function, decreasing or increasing stimulatory signals to one or more leads allows the invention to more accurately provide stimulation to the atrial endothelium, ventricular endothelium, or other cardiac tissue to provide a level of granularity to the stimulation function, programming leads so that sensing leads are not required to share the function of a shocking/stimulation leads, and bypassing damaged or degraded leads to allow continued functioning without requiring the entire device to be removed from a patient, this increasing the longevity of implanted devices using the inventive technology. Doing so would allow customization of lead functions (Paragraph 0081), as recognized by Marin y Kall.
Claims 2, 15, and 38 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 2 would be allowable for disclosing the electrode system of claim 1
wherein the atraumatic tip comprises a domed head connected to a cylindrical sidewall, said cylindrical sidewall having a sloped proximal edge connected to a tapered coupling, said tapered coupling forming a smooth transition to an outer diameter of the insulated wire. Avellanet, Daniels, Eigler, Marin y Kall, Zeus, Min, Dabney, and An do not disclose that the cylindrical sidewall has a sloped proximal edge connected to a tapered coupling.
Eigler, which was identified as the closest prior art that details the domed head, cylindrical sidewall, tapered coupling, and insulated wire, does not disclose a sloped proximal edge that connects the cylindrical sidewall to the tapered coupling (See Annotated Fig. 4 below), and thus this claim would be allowable.
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Annotated Fig. 4 (Eigler)
Claim 15 would be allowable for disclosing the electrode system according to
claim 12, wherein the female Luer connector has a connector orientation that is keyed to a leads orientation of the electrical leads, wherein the connector orientation informs an operator of the leads orientation. Avellanet, Daniels, Eigler, Marin y Kall, Zeus, Min, Dabney, and An do not disclose that the female Luer connector has a connector orientation that is keyed to a leads orientation as stated in the above claim, and thus this claim would be allowable.
Claim 38 would be allowable for disclosing a self-positioning, quick-deployment low profile transvenous electrode system for pacing of a heart with a pacemaker, comprising: a pair of insulated electrical wires to form a first ventricle lead and a second ventricle lead, the first and the second ventricle leads disposed within an outer steerable catheter sheath, said outer steerable catheter sheath being removable from said first and said second ventricle leads when inserted into the heart for deploying the first ventricle lead and the second ventricle lead to the ventricle, said outer steerable catheter sheath being entirely removed from the ventricle when the transvenous electrode system is engaged, each of the first and the second ventricle leads have a proximal body portion, a distal end portion, and a tip portion, the proximal body portion made from a radiopaque polymer-covered copper wire, the distal end portion made from shape memory material, the shape memory material selected from stainless steel, spring steel, cobalt-chromium alloy, nickel-titanium alloy, and mixtures thereof, the tip portion comprising a domed head connected to a cylindrical sidewall, said cylindrical sidewall having a sloped proximal edge connected to a tapered coupling, said tapered coupling forming a smooth transition to an outer diameter of the insulated wire, the tip portion made from shape memory material and a radiopaque material, the radiopaque material selected from a barium-containing compound, a bismuth-containing compound, a steel compound, a tungsten-containing compound, and mixtures thereof, the two ventricle leads are offset 180 degrees from each other, the steerable catheter sheath is about 1.3mm diameter or 4 French and is comprised of a distal portion and a proximal portion, and has a distance marker every 10cm along its entire length, the distal portion of the steerable catheter sheath is 5cm in length and has a 0.010" pitch coil and a biocompatible polymer cover, the proximal portion of the steerable catheter sheath is 30cm in length, has a 0.020" pitch coil, a biocompatible polymer cover, at a proximal end of the proximal portion has a hub element, a Touhy-Borst access connector with a side port, an actuator dial that allows the steerable catheter sheath to be shaped and controlled, a deployment stop, and a cable junction housing.
Avellanet, Daniels, Eigler, Marin y Kall, Zeus, Min, Dabney, and An do not disclose that the cylindrical sidewall has a sloped proximal edge connected to a tapered coupling. Eigler, which was identified as the closest prior art that details the domed head, cylindrical sidewall, tapered coupling, and insulated wire, does not disclose a sloped proximal edge that connects the cylindrical sidewall to the tapered coupling (See Annotated Fig. 4 Above), and thus this claim would be allowable.
Conclusion
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/H.A.H./Patent Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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