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 . Claims 1-20 are currently pending.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the frame member of claim 1 in combination to the frame of claim 11 need to be shown together or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Claim 11 is 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. The frame is disclosed throughout the specification (element 150) and is properly claimed; however the frame member is already claimed in claim 1 (possible antecedent basis issue), but the specification does not disclose both of these claimed elements as being two separate portions of the end effector.
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 11 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 11 recites the limitation "the frame" in line two while claim 1 recites a “frame member”. For purposes of prosecution these are being considered the same element given the original disclosure. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Basu et al. US publication 2021/00771833 (hereinafter Basu).
Regarding claim 1, Basu discloses an end effector for a medical probe comprising: a frame member that extends along a longitudinal axis (Figures 1-5 element 250); and first and second electrodes (first electrode 232 and second electrode 234 of Figure 7) disposed generally orthogonal with respect to the longitudinal axis of the frame member (Figure 5) so that one of the first and second electrodes is recessed with respect to the other of the first and second electrodes to prevent such recessed electrode from tissue contact (Figures 5 and 7, where the recessed electrode 234 of Figure 7 is within membrane 254 which is part of 216, while electrode 232 is on top of the substrate 252).
Regarding claim 11, Basu discloses the electrodes (230, 232, 234) and a first membrane (substrate 252 and membrane 254) extending between the one or more struts on a first side of the end effector ([0054] which details that central layer 250 can in fact being a series of strips which is being read as struts) and being exposed to ambient environment (Figures 2B, 5 which shows the membrane exposed to the environment), the first electrode (electrode 232, which is technically affixed to the membrane with intervening layers, directly affixed is not claimed) and the second electrode being affixed to the first membrane such that the second electrode is disposed within a recess of the first membrane (second electrode 234 is within a recess of 254 as per Figures 5, 7).
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.
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 non-obviousness.
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 1-4, 6-9, and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Beeckler US Publication 2020/0205737 (hereinafter Beeckler) in view of Mest et al. US Patent 6,405,067 (hereinafter Mest).
Regarding claim 1, Beeckler discloses a frame member (24) that extends along a longitudinal axis (Figures 1-2A); and first and second electrodes disposed generally orthogonal with respect to the longitudinal axis of the frame member (electrodes 36a-b) but is silent on one of the electrodes in the pair being recessed.
Mest teaches a catheter that includes bipolar sensing electrodes where one of the electrodes of the first and second electrodes is recessed with respect to the other of the first and second electrodes to prevent such recessed electrode from tissue contact (electrodes 35 and 39, where 39 is recessed; see Figure 5 as well as column 1 lines 44-53 and column 6 lines 33-37 which also details that the bipolar sensing pair affords far-field sensing). It would have been obvious to the skilled artisan before the effective filing date to utilize the recessed electrode as taught by Mest with the electrodes of Beeckler in order to allow for near-field sensing and far-field signal removal.
Regarding claim 2, Beeckler discloses that the first and second electrodes are disposed on a substrate spaced apart and not in contact with the frame member (Figure 2A electrodes 36a-b, substrate 30, frame 24, which shows the elements are spaced as claimed).
Regarding claim 3, Beeckler discloses that the frame member is encapsulated in a polymer to maintain a gap from the frame member to the first and second electrodes ([0056] which details multiple polymeric layers encapsulating the frame).
Regarding claim 4, Beeckler discloses that the second electrode is entirely circumscribed by the first electrode (Figure 2A, electrodes 36a-b).
Regarding claim 6, Beeckler discloses that the first electrode comprising a first surface area generally equal to a second surface area of the second electrode ([0055] which details that the areas can be within 5 or 10% of each other, which the Figure 2A supports, relatively without exact numbers).
Regarding claim 7, Beeckler discloses that the first electrode being configured to measure electrocardiogram signals from tissue (either of electrodes 36a-b can perform this task), and the second electrode being configured to sense far-field signals (electrodes 36a-b are fully capable without any additional structural modifications of performing this claimed functional language). It should be noted, though not relied upon for the purposes of prosecution, but Mest specifically details far-field sensing and its removal (column1 lines 45-53).
Regarding claim 8, Beeckler discloses that an end effector with a first side (top of the spline where the electrodes 36a-b are located), however a depression is not detailed. Mest teaches a depression that one of the electrodes sits within (Figure 5 near 38/39). Once applied to the device of Beeckler, the resultant combination would have reasonably included a recessed electrode that is within a depression of the substrate (this type of recess can be shown in teaching reference Marecki et al. US Publication 2015/0351652 at Figures 7A-B which shows that the second electrode can be flush or fully recessed within the substrate; this is simply shown as how the skilled artisan would have been inclined to arrange part of the combination of Beeckler and Mest with one of the electrodes being recessed within the substrate itself). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the electrode within the depression of the side as taught by Mest with the device of Beeckler in order to prevent the electrode from contacting tissue.
Regarding claim 9, Beeckler includes multiple pairs of electrodes (see Figures 2A which shows multiple pairs including a third and fourth electrode), however Beeckler is still silent on the depression. Mest teaches the same depression that applied to the first pair of electrodes (see contents of rejected claim 8 for the depression and motivation above).
Regarding claim 13, Beeckler discloses an end effector for a medical probe comprising: 13. a first electrode on a first side of the end effector (electrode 36b), the first electrode comprising a first surface exposed to ambient environment and configured to contact tissue (Figures 1-2A at 36); and a second electrode on the first side of the end effector (electrode 36a), the second electrode being at least partially circumscribed by the first electrode (Figure 2A at electrodes 36a-b), the second electrode comprising a second surface exposed to the ambient environment (Figure 2A), but is silent on the second electrode’s surface being inhibited from contacting tissue.
Mest and inhibited from contacting tissue by virtue of a first vertical gap between the first surface and the second surface (electrodes 35 and 39, where 39 is recessed; see Figure 5 as well as column 1 lines 44-53 and column 6 lines 33-37, where they are shown to have different heights to prevent the second electrode from contacting tissue). It would have been obvious to the skilled artisan before the effective filing date to utilize the recessed electrode as taught by Mest with the electrodes of Beeckler in order to allow for near-field sensing and far-field signal removal.
Regarding claim 14, Beeckler discloses that the first surface and the second surface comprising planar surfaces (Figure 2A electrodes 36a-b).
Regarding claim 15, Beeckler discloses that the first surface and the second surface extending along a longitudinal axis and facing orthogonal to the longitudinal axis (Figure 2A which shows the electrodes extending out in an orthogonal direction from the frame/spline).
Regarding claim 16, see contents of rejected claim 2 above, see also Figure 2A.
Regarding claim 17, see contents of rejected claim 8 above.
Regarding claim 18, see contents of rejected claims 8-9 above, where the resultant electrode configuration described above would meet these limitations and for the same reasons.
Regarding claim 19, Beeckler discloses that the first electrode and the third electrode are configured to measure electrocardiogram signals as a bipolar pair (the electrodes of both Beeckler and Mest are fully capable of this with no additional structural modification).
Regarding claim 20, see contents of rejected claims 8-9 above, where the resultant electrode configuration described above would meet these limitations and for the same reasons.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Beeckler in view of Mest, and in further view of Woloszko et al. US Publication 2004/0186469 (hereinafter Woloszko).
Regarding claim 5, Beeckler discloses the first and second electrodes (above), but is silent on the arcuate sections. Woloszko teaches an ablation catheter that includes a first electrode with a plurality of arcuate sections disposed around a perimeter of the second electrode such that plurality of arcuate sections are spaced apart from each other (Figure 14 and [0137] which details that several types of shapes can be utilized for the electrode as desired along with the complimenting recess). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the shaping as taught by Woloszko with the electrode shape of Beeckler as they are art recognized equivalents ([0137]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Beeckler in view of Mest, and in further view of Tobey et al. US Publication 2020/037101 (hereinafter Tobey).
Regarding claim 10, though the splines/frame of Beeckler as per Figure 1 could physically be flattened with small amounts of force given the material choice, during use there is no reason for the end effector to end up flattened. Tobey teaches a mapping catheter that includes an end effector being substantially planar along a longitudinal axis (Figures 10-15). It would have been obvious to the skilled artisan before the effective filing date to utilize the planar configuration as taught by Tobey with the device of Beeckler as the basket configurations are art recognized equivalents of each other (see Figures 8-18) and would have yielded predictable results of affording ablation or sensing along a specific portion of the human anatomy.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Beeckler in view of Mest, and in further view of Tobey and Govari et al. US Publication 2021/0128010 (hereinafter Govari).
Regarding claim 12, Beeckler is silent on the end effector being configured to expand to a planar configuration as well as the inductive loops. Tobey teaches the planar configuration (see contents of rejected claim 10 above), which is combinable for the same above mentioned reasons. Tobey is also silent on the inductive coils. Govari teaches a basket catheter that includes an end effector comprising: a plurality of inductive loops coupled to the end effector (elements 62/64 as per [0031]) such that each inductive loop of the plurality of inductive loops comprises a respective axis orthogonal to the end effector in the planar configuration (Figure 4B which shows the axis around the loop’s central axis stands orthogonal to the direction of the splines axis). It would have been obvious to the skilled artisan before the effective filing date to utilize the inductive loops as taught by Govari with the device of Beeckler in order to aid in determining the spline/frame position during use as is known in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian M Antiskay whose telephone number is (571)270-5179. The examiner can normally be reached M-F 10am-6pm EST.
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/BRIAN M ANTISKAY/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794