Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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.
Claim 16 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.
Claim 16 recites the limitation “the marker” in line 2. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 8-13, and 17-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Marshall et al. (US Pub.: 2016/0158567 A1 – Applicant Cited).
Regarding claim 1, Marshall discloses an implantable medical electrical lead (e.g. Figs. 1A, 2, 3A – medical electrical lead 10) comprising:
a lead body defining a proximal portion and a distal portion (e.g. Fig. 1A – elongated lead body 12; paragraph 0006), wherein at least a part of the distal portion of the lead body (12) defines a three-dimensional undulating configuration (e.g. Fig. 1A – undulating configuration 22; paragraphs 0035, 0042 – 3-dimensional serpentine shape);
a proximal end of the distal portion disposed adjacent to the three-dimensional undulating configuration (e.g. paragraphs 0035, 0042);
a first defibrillation electrode (e.g. Figs. 1A, 3A – defibrillation electrode segment 28a)
and a second defibrillation electrode (e.g. Figs. 1A, 3A – defibrillation electrode segment 28b) disposed along the three-dimensional undulating configuration (22) spaced apart from one another by a distance (e.g. paragraph 0035);
and a pacing electrode (e.g. Figs. 1A, 3A – pace/sense electrode 32b) disposed between the first defibrillation electrode (28a) and the second defibrillation electrode (28b), the pacing electrode (32b) configured to perform at least one of delivering a pacing pulse to a heart and sensing cardiac electrical activity of the heart (e.g. paragraphs 0040, 0044),
wherein the first defibrillation electrode (28a) is disposed between the proximal end and the pacing electrode (32b) (e.g. Fig. 3A; paragraph 0041),
a first portion of the first defibrillation electrode (28a), a first portion of the second defibrillation electrode (28b), and the pacing electrode (32b) are disposed along a plane (e.g. Fig. 3A; paragraph 0042 – horizontal (i.e. x-y) plane),
and a second portion of the first defibrillation electrode (28a) adjacent to the pacing electrode (32b) arcs in a direction orthogonal to the plane (e.g. paragraph 0042 – extend in the z-direction, perpendicular to the horizontal plane).
Regarding claim 2, Marshall discloses the implantable medical lead of claim 1 as discussed above, and Marshall further teaches wherein the first portion of the first defibrillation electrode (28a), the first portion of the second defibrillation electrode (28b), the proximal end of the distal portion, and the pacing electrode (32b) are disposed along the plane (e.g. Fig. 3A; paragraph 0042).
Regarding claim 3, Marshall discloses the implantable medical lead of claim 1 as discussed above, and Marshall further teaches wherein a second portion of the second defibrillation electrode (28b) adjacent to the pacing electrode (32b) arcs in a direction orthogonal to the plane (e.g. Fig. 3A; paragraph 0042).
Regarding claim 4, Marshall discloses the implantable medical lead of claim 1 as discussed above, and Marshall further teaches wherein the three-dimensional undulating configuration (22) defines a three-dimensional parametric curve (e.g. paragraph 0042).
Regarding claim 8, Marshall discloses the implantable medical lead of claim 1 as discussed above, and Marshall further teaches wherein the proximal end comprises a second pacing electrode (e.g. Figs. 1A, 3A – pace/sense electrode 32a), wherein the second pacing electrode (32a) is configured to perform at least one of delivering a pacing pulse to a heart and sensing cardiac electrical activity of the heart (e.g. paragraphs 0040, 0044), and the first defibrillation electrode (28a) is disposed between the pacing electrode (32b) and the second pacing electrode (32a) (e.g. Fig. 3A; paragraphs 0038, 0041).
Regarding claim 9, Marshall discloses the implantable medical lead of claim 8 as discussed above, and Marshall further teaches wherein a longitudinal axis passes through the pacing electrode (32b) and the second pacing electrode (32a) (e.g. paragraphs 0041-0042), and the first defibrillation electrode (28a) and the second defibrillation electrode (28b) disposed along the three-dimensional undulating configuration (22) are positioned apart from the longitudinal axis (e.g. Fig. 3A; paragraphs 0041-0042).
Regarding claim 10, Marshall discloses the implantable medical lead of claim 1 as discussed above, and Marshall further teaches wherein the first defibrillation electrode (28a) and the second defibrillation electrode (28b) are configured to be positioned adjacent to a sternum or to contact the sternum (e.g. paragraphs 0027, 0041-0042).
Regarding claim 11, Marshall discloses the implantable medical lead of claim 10 as discussed above, and Marshall further teaches wherein the first defibrillation electrode (28a) and the second defibrillation electrode (28b) are configured to contact the sternum, wherein the contact with the sternum is to cause the pacing electrode (32b) to be positioned away from the sternum and towards the heart (e.g. paragraphs 0027, 0041).
Regarding claim 12, Marshall discloses the implantable medical lead of claim 1 as discussed above, and Marshall further teaches wherein the pacing electrode (32b) is configured to contact the heart or to be positioned adjacent to the heart (e.g. paragraphs 0040-0042).
Regarding claim 13, Marshall discloses the implantable medical lead of claim 12 as discussed above, and Marshall further teaches wherein the second pacing electrode (32a) is configured to contact the heart or positioned adjacent to the heart (e.g. paragraphs 0040-0042).
Regarding claim 17, Marshall discloses an implantable medical system (e.g. Fig. 1A – implantable cardioverter-defibrillator system 8) comprising:
an implantable medical device (e.g. Fig. 1A – ICD 9) comprising:
a housing (e.g. paragraphs 0025, 0043);
and therapy delivery circuitry within the housing (e.g. Fig. 10 – therapy module 104; paragraphs 0064, 0068);
and an implantable medical lead (e.g. Figs. 1A, 2, 3A – medical electrical lead 10) configured to be coupled to the medical device (9) comprising:
a lead body defining a proximal portion and a distal portion (e.g. Fig. 1A – elongated lead body 12; paragraph 0006), wherein at least a part of the distal portion of the lead body (12) defines a three-dimensional undulating configuration (e.g. Fig. 1A – undulating configuration 22; paragraphs 0035, 0042 – 3-dimensional serpentine shape);
a proximal end of the distal portion disposed adjacent to the three-dimensional undulating configuration (e.g. paragraphs 0035, 0042);
a first defibrillation electrode (e.g. Figs. 1A, 3A – defibrillation electrode segment 28a)
and a second defibrillation electrode (e.g. Figs. 1A, 3A – defibrillation electrode segment 28b) disposed along the three-dimensional undulating configuration (22) spaced apart from one another by a distance and disposed distally along the three-dimensional undulating configuration (e.g. Fig. 3A; paragraph 0035);
and a pacing electrode (e.g. Figs. 1A, 3A – pace/sense electrode 32b) disposed between the first defibrillation electrode (28a) and the second defibrillation electrode (28b), the pacing electrode (32b) configured to perform at least one of delivering a pacing pulse to a heart and sensing cardiac electrical activity of the heart (e.g. paragraphs 0040, 0044),
wherein the first defibrillation electrode (28a) is disposed between the proximal end and the pacing electrode (32b) (e.g. Fig. 3A; paragraph 0041),
a first portion of the first defibrillation electrode (28a), a first portion of the second defibrillation electrode (28b), and the pacing electrode (32b) are disposed along a plane (e.g. Fig. 3A; paragraph 0042 – horizontal (i.e. x-y) plane),
and a second portion of the first defibrillation electrode (28a) adjacent to the pacing electrode (32b) arcs in a direction orthogonal to the plane (e.g. paragraph 0042 – extend in the z-direction, perpendicular to the horizontal plane).
Regarding claim 18, Marshall discloses the implantable medical system of claim 17 as discussed above, and Marshall further teaches wherein the first portion of the first defibrillation electrode (28a), the first portion of the second defibrillation electrode (28b), the proximal end of the distal portion, and the pacing electrode (32b) are disposed along the plane (e.g. Fig. 3A; paragraph 0042).
Regarding claim 19, Marshall discloses the implantable medical system of claim 17 as discussed above, and Marshall further teaches wherein a second portion of the second defibrillation electrode (28b) adjacent to the pacing electrode (32b) arcs in a direction orthogonal to the plane (e.g. Fig. 3A; paragraph 0042).
Regarding claim 20, Marshall discloses the implantable medical system of claim 17 as discussed above, and Marshall further teaches wherein the proximal end comprises a second pacing electrode (e.g. Figs. 1A, 3A – pace/sense electrode 32a), wherein the second pacing electrode (32a) is configured to perform at least one of delivering a pacing pulse to a heart and sensing cardiac electrical activity of the heart (e.g. paragraphs 0040, 0044), and the first defibrillation electrode (28a) is disposed between the pacing electrode (32b) and the second pacing electrode (32a) (e.g. Fig. 3A; paragraphs 0038, 0041).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 5-6 are rejected under 35 U.S.C 103 as being unpatentable over Marshall and further in view of Marshall et al. (US Pub.: 2021/0031048 A1) (hereinafter, “Marshall ‘048”).
Regarding claim 5, Marshall discloses the implantable medical lead of claim 1 as discussed above, and Marshall further teaches that the pacing electrode may be any of a number of different types of electrodes including a ring/directional electrode (e.g. paragraph 0040).
However, Marshall does not explicitly teach wherein the pacing electrode is segmented.
Marshall ‘048, in a same field of endeavor of cardiac stimulation, discloses wherein the pacing electrode is segmented (e.g. paragraph 0048).
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 the implantable medical lead of Marshall to incorporate wherein the pacing electrode is segmented, as taught and suggested by Marshall ‘048, because it is a simple substitution of one known electrode type for another in order to obtain the predictable results of reliably delivering pacing pulses to the heart.
Regarding claim 6, Marshall in view of Marshall ‘048 teaches the implantable medical lead of claim 5 as discussed above, and Marshall further teaches wherein the pacing electrode is positioned about the circumference of the lead body (e.g. paragraphs 0040-0042).
Claim 7 is rejected under 35 U.S.C 103 as being unpatentable over Marshall and further in view of Zhou et al. (US Pub.: 2021/0015390 A1).
Regarding claim 7, Marshall discloses the implantable medical lead of claim 1 as
discussed above. However, Marshall does not explicitly teach wherein a mask is disposed at least over a portion of an outer surface of the pacing electrode.
Zhou, in a same field of endeavor of cardiac stimulation, discloses wherein a mask is disposed at least over a portion of an outer surface of the pacing electrode (e.g. paragraph 0054).
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 the implantable medical lead of Marshall to incorporate wherein a mask is disposed at least over a portion of an outer surface of the pacing electrode, as taught and suggested by Zhou, in order to allow for more targeted pacing at a tissue site (Zhou, paragraph 0054).
Claims 14 and 16 are rejected under 35 U.S.C 103 as being unpatentable over Marshall and further in view of Cole et al. (US Pub.: 2014/0255298 A1).
Regarding claim 14, Marshall discloses the implantable medical lead of claim 1 as
discussed above. However, Marshall does not explicitly teach further comprising a marker to indicate orientation of the lead.
Cole, in a same field of endeavor of cardiac stimulation, discloses further comprising a marker to indicate orientation of the lead (e.g. paragraphs 0006, 0034 – radiopaque markers).
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 the implantable medical lead of Marshall to incorporate a marker to indicate orientation of the lead, as taught and suggested by Cole, in order to allow for the implantable lead to be visible on an x-ray so that administering personnel can have a visual assurance that the lead is designed for safe application of the medical procedure of interest (Cole, paragraph 0006).
Regarding claim 16, Marshall discloses the implantable medical lead of claim 1 as discussed above. However, Marshall does not explicitly teach a marker and wherein the marker is a radiopaque marker.
Cole, in a same field of endeavor of cardiac stimulation, discloses a marker and wherein the marker is a radiopaque marker (e.g. paragraphs 0006, 0034 – radiopaque markers).
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 the implantable medical lead of Marshall to incorporate a marker wherein the marker is a radiopaque marker, as taught and suggested by Cole, in order to allow for the implantable lead to be visible on an x-ray so that administering personnel can have a visual assurance that the lead is designed for safe application of the medical procedure of interest (Cole, paragraph 0006).
Claim 15 is rejected under 35 U.S.C 103 as being unpatentable over Marshall and further in view of Cole and further in view of Stewart et al. (US Pub.: 2012/0265084 A1).
Regarding claim 15, Marshall in view of Cole teaches the implantable medical lead of
claim 14 as discussed above. However, Marshall in view of Cole does not explicitly teach wherein the marker indicates orientation of the pacing electrode.
Stewart, in a same field of endeavor of cardiac sensing/implantation systems, discloses wherein the marker indicates orientation of the pacing electrode (e.g. paragraph 0030).
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 the combination of Marshall and Cole to incorporate wherein the marker indicates orientation of the pacing electrode, as taught and suggested by Stewart, for the purpose of being able to better track the position/location of the pacing electrode in real-time during a medical procedure and to allow for more tailored therapy (Stewart, paragraph 0030).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
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/D.T./Examiner, Art Unit 3792
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
