DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 11 is objected to because of the following informalities: in line 2, it appears that “can” should read --and--. Appropriate correction is required.
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 1-20 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 claim(s) contains 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 inventor(s), at the time the application was filed, had possession of the claimed invention.
In regards to claim 1, the claim requires a cardiac lead with at least one electrode in the distal region. Although Fig. 3A appears to depict an electrode that extends along both the left and right sides of the atrial septum, and several embodiments have an additional electrode or electrodes in locations remote from the atrial septum, the examiner was unable to find support in the original disclosure for at least one electrode that simultaneously meets all limitations of extending along both the left and right sides of the atrial septum, being in electrical communication with endocardium of both the left and right atrium, and extending away from a structure engaged with opposite sides of an atrial septum. Although the previous claims were drawn to a lead that could place an electrode or electrodes in various locations, the examiner was unable to find support for a lead with at least one electrode in the distal region with the electrode meeting the requirements of the claim.
In regards to claims 8, 9, 15 and 20, the examiner was unable to find support in the original disclosure for a transeptal structure in the form of a clip. The only mention of a clip is in paragraph 0055 and referring to an unrelated feature. If a “clip” requires or implies some sort of functionality or structure beyond a “dip,” this does not appear to be supported by the original disclosure.
In regards to claims 12-15, the claims appear to be drawn to an unsupported mixing of embodiments in light of the amendments to claim 1. Claim 1 requires the at least one electrode to be at a distal region of the cardiac lead and the transeptal structure to cause the electrode to extend along both the right and left sides of the atrial septum. Claims 12-15 requires that the at least one electrode is configured as a lattice. The only mention of a lattice in the original disclosure is drawn to the embodiment of Figs. 8C, 8D, and paragraphs 0074-0076. No embodiments include “at least one electrode” that both extends along the left and right side of the atrial septum (the “structure” appears to be in reference to the embodiment of Figs. 3A-G) and is a lattice (the “lattice” of the disclosure referring to elements 813, 814 and 815 in Fig. 8C). Further, claim 15 further sets forth a “U-shaped clip.” This appears to be the “structure” already set forth in claim 1 and the original disclosure does not appear to support a combination of a structure meeting the requirements of claim 1 and a second, additional “U-shaped clip” that meets the requirements of claim 15.
In regards to claims 19 and 20, these claims appear to be drawn to an unsupported mixing of embodiments. Claim 1 requires the at least one electrode to be at a distal region of the cardiac lead and the transeptal structure to cause the electrode to extend along both the right and left sides of the atrial septum. Claim 19 requires that the at least one electrode is part of a mitral valve device (see Fig. 9). There does not appear to be an embodiment where the at least one electrode contacts the left and right side of the atrial septum, is on the distal portion of the lead and is part of a mitral valve device.
The remaining claims are rejected by virtue of their dependency.
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 14 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 14 recites that the at least one electrode is on the lattice, but claim 12 (from which it depends) recites that the at least one electrode is configured as a lattice. It appears that this requires two mutually exclusive concepts that the electrode is both itself a lattice and the electrode is on the lattice. Appropriate clarification is respectfully requested.
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 1-11 and 16-18 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by McGee et al. (US 5,855,592, hereinafter “McGee”).
In regards to claim 1, McGee discloses an implantable medical device (Figs. 13 and 14), comprising: a cardiac lead having a distal region and a proximal end (Fig. 13, element 136), the proximal end of the cardiac lead adapted to be coupled to an electronics enclosure (element 60, col. 14, lines 29-40), the distal region of the cardiac lead having at least one electrode (Figs. 13 and 14, distal elements 134 and distal portions of splines 132), a structure configured to be implanted by being engaged with opposite sides of an atrial septum (Figs. 13 and 14; body 126 and bases of splines 132; col. 15, lines 56-col. 16, line 4, “[t]he spline sets 132 are memory-biased toward the body 126 (as FIG. 14 shows)…[t]he memory bias hold the electrodes 134 against the septal wall”) the structure, when engaged with the opposite sides of the atrial septum, causing the at least one electrode of the distal region of the cardiac lead to (i) extend along both the left and right sides of the atrial septum and (ii) be in electrical communication with endocardium of both the left and right atrium (Figs. 13 and 14) via the at least one electrode that extend away from the structure (Figs. 13 and 14; col. 15, lines 56-col. 16, line 4).
In regards to claim 2, the structure comprises a septal closure device (Figs. 13 and 14, element 126, plugging the hole formed in the septum).
In regards to claim 3, a first elongated portion of the at least one electrode extends along the left side of the atrial septum and further along the endocardium of the left atrium away from the atrial septum, and wherein a second elongated portion of the at least one electrode extends along the right side of the atrial septum and further along the endocardium of the right atrium away from the atrial septum (Figs. 13 and 14, top right and left arms of the system; the examiner is considering this to be “away from the atrial septum” because the electrodes on this portion are on locations where a line normal to the electrode points out the top of the heart instead of into the atrial septum).
In regards to claim 4, the at least one electrode includes (i) a first electrode supported by the structure and configured to extend away from and to maintain contact with the atrial septum and the person's endocardium in the left atrium and (ii) a second electrode supported by the structure and configured to extend away from and to maintain contact with the atrial septum and endocardium in the right atrium (Figs. 13 and 14, col. 15, lines 56-col. 16, line 4).
In regards to claim 5, the at least one electrode further includes a second electrode that extends along the endocardium within the left atrium of the patient's heart (Figs. 13 and 14, top right arm; see also col. 15, lines 53-56, Fig. 8), and wherein the second electrode extends along the endocardium within the right atrium of the patient's heart (Figs. 13 and 14, top left arm; see also col. 15, lines 53-56, Fig. 8).
In regards to claim 6, the structure comprises a shape memory material (col. 15, line 65 to col. 16, line 4).
In regards to claim 7, the structure includes protrusions configured to mate to the left and right sides of the atrial septum (Figs. 13 and 14, bottom left and right arms of the system; see also col. 15, lines 53-56, Fig. 8).
In regards to claim 8, the structure includes a U- shaped clip (Figs. 13 and 14, the U-shape formed between the upper left and upper right opposing arms of the system; col. 15, line 65-col. 16, line 4; the opposing arms are biased towards each other, forming a clip).
In regards to claim 9, the at least one electrode is on the U- shaped clip (Figs. 13 and 14).
In regards to claim 10, the distal region is coupled to the structure, and wherein the at least one electrode is configured to have a side surface restrained against the left and right side of the atrial septum and endocardium in the left and right atrium (Figs. 13 and 14; col. 15, lines 50 to col. 16, line 4; Fig. 8; the electrodes are restrained against the left and right side of the septum and endocardium with the spline sets).
In regards to claim 11, at least one electrode includes protrusions extending along sides thereof and configured to mate to the endocardium (Figs. 8, 13, 14; the “one or more electrodes” comprises multiple electrodes 134, each having sides protruding from the splines and configured to mate with the endocardium).
In regards to claim 16, an elongated portion of the at least one electrode includes a plurality of electrodes that extend along the endocardium of the left atrium away from the atrial septum (Figs. 13 and 14; top right arm of the system; the examiner is considering each of the electrodes 134 to be “away from the atrial septum” because the electrodes on this portion are on locations where a line normal to the electrode points out the top of the heart instead of into the atrial septum.
In regards to claim 17, the system further comprises a second plurality of electrodes connected to the structure and configured to extend away from and to maintain contact with the endocardium of the right atrium person's endocardium (Figs. 13 and 14, any of the top left, bottom left or bottom right arms of the system; col. 15, lines 50-58; Fig. 8).
In regards to claim 18, the plurality of electrodes extend from the structure within the left atrium of the patient's heart (Fig. 13), and wherein the second electrodes extend away from the structure within the right atrium of the patient's heart (Figs. 13 and 14, the left top or bottom arm of the system).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 12-15, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over McGee in view of Osypka (US 2013/0331920, hereinafter “Osypka”). McGee discloses the essential features of the claimed invention except for:
the at least one electrode being configured as a lattice;
wherein the lattice is configured to electrically couple the cardiac lead to the person's endocardium in both the left and right atrium;
wherein the at least one electrode is on the lattice;
wherein the system further includes a U-shaped clip configured to attach to a septum of the person, and wherein the lattice comprises: a first wire coupled to the U-shaped clip and configured to be restrained against the person's endocardium; a second wire also coupled to the U-shaped dip and configured to be restrained against the person's endocardium; and an interconnecting wire connected to the first and second wires to space apart the first and second wires while restrained against the person's endocardium;
the system further including a mitral valve device, and the electrode is part of the mitral valve device;
or that the structure includes a U-shaped clip configured to be attached to the person's septum; and the electrode is coupled to the U-shaped clip by way of a shape memory wire that is configured to be restrained against the person's endocardium between the mitral valve device and the U-shaped clip.
However, Osypka in the same field of endeavor of intracardiac stimulation systems teaches:
at least one electrode being configured as a lattice (e.g., Fig. 8c; par. 0031);
wherein the lattice is configured to electrically couple the cardiac lead to the person's endocardium in both the left and right atrium (e.g., Fig. 2, restrained to the endocardium at the septum and wall of the left atrium; electrically coupling by forming the circuit with electrode 2);
wherein the at least one electrode is on the lattice (Fig. 2; the electrode is secured via lead passing through the lattice, and so the examiner is considering the electrode to be “on” the lattice – no direct connection between the electrode and lattice is required, and the lattice itself is a bipolar electrode (pars. 0031, 0048)); and
wherein the system further includes a U-shaped clip configured to attach to a septum of the person (e.g., Fig. 2; the top half of element 1 forms a U-shape configured to attach to a septum), and wherein the lattice comprises: a first wire coupled to the U-shaped clip and configured to be restrained against the person's endocardium (Fig. 8c; pars. 0047-0048, one of the two bipolar conductors); a second wire also coupled to the U-shaped dip and configured to be restrained against the person's endocardium (Fig. 8c; pars. 0047-0048, the other of the two bipolar conductors); and an interconnecting wire connected to the first and second wires to space apart the first and second wires while restrained against the person's endocardium (Fig. 8c, any of the other struts connecting the bipolar conductors) to provide the predictable results of a large surface area electrode for permanent placement that is self-expandable and forms a double disc that bridges the left and right artium to thereby allow for left atrial heart stimulation (pars. 0010, 0011, 0033).
Osypka further teaches the system further including a mitral valve device, and the electrode is part of the mitral valve device (Fig. 3b; portion of lead passing through the mitral valve and in the left ventricle);
and that the structure includes a U-shaped clip configured to be attached to the person's septum (Fig. 3b, the top half of element 1 forms a U-shape and is attached to the septum); and the electrode is coupled to the U-shaped clip by way of a shape memory wire that is configured to be restrained against the person's endocardium between the mitral valve device and the U-shaped clip (Fig. 3b, par. 0047; the electrode is (indirectly) coupled to the clip of element 1 via the memory metal threads of element 1 (par. 0047) and is restrained against the septal endocardium over the portion between the mitral valve device and clip) to provide the predictable results of a large surface area electrode for permanent placement that is self-expandable and forms a double disc that bridges the left and right artium to thereby allow for left ventricle heart stimulation (pars. 0010, 0011, 0035). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify McGee by providing the modifications above to provide the predictable results set forth above.
Response to Arguments
Applicant's arguments filed 10/7/2025 have been fully considered but they are not persuasive in part and moot in part. In regards to McGee, Applicant argued that the body 126 of McGee merely passes through the atrial septum, but is not engaged with opposite sides of an atrial septum. However, the examiner respectfully maintains the basis of rejection with the “structure” recited in claim 1 being the body 126 of McGee in combination with the base portions of splines 132. McGee describes in Figs. 13 and 14 and at the bottom of column 15 to the top of column 16 that these splines are memory biased and “hold the electrodes 134 against the septal wall within the left atrium” and “holds the electrodes 134 against the septal wall within the right atrium,” and so the examiner maintains that this fairly discloses the claimed subject matter. The rejections under section 102 in view of Osypka and (separately) Wolf, as well as the double-patenting rejections have been withdrawn. Please note the new rejections, necessitated by amendment, under section 112 above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792