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 .
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.
Claim Objections
Claim 1 objected to because of the following informalities:
“and conform” in line 5 should be written “and configured to conform”
“at least one electrodes” in line 7 should be written “at least one electrode”
Appropriate correction is required.
Claim 3 objected to because of the following informalities:
“arranged to such” in line 2 should be written “arranged such”
“at least one electrodes” in lines 2-3 should be written “at least one electrode”
Appropriate correction is required.
Claim 4 objected to because of the following informalities:
“at least one electrodes” in line 1 should be written “at least one electrode”
Appropriate correction is required.
Claim 5 objected to because of the following informalities:
“the radiofrequency ablation” in line 1 should be written “the radiofrequency ablation energy”
Appropriate correction is required.
Claim 6 objected to because of the following informalities:
“the splines” in line 1 should be written “the plurality of splines”
“at least one electrodes” in lines 2-3 should be written “at least one electrode”
Appropriate correction is required.
Claim 8 objected to because of the following informalities:
“the splines” in line 1 should be written “the plurality of splines”
Appropriate correction is required.
Claim 12 objected to because of the following informalities:
“the other” in line 2 should be written “another”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 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 “flexible basket catheter” in lines 3-4. It is unclear whether this limitation is referring to the “basket catheter” recited in line 1 or a different basket catheter.
Claims 2-8 are rejected as being dependent upon a rejected base claim.
Claim 9 recites the limitation “a plurality of electrodes” in line 1. It is unclear whether this limitation is referring to the “at least one electrode” recited in claim 1 or a different plurality of electrodes.
Claims 10-20 are rejected as being dependent upon a rejected base claim.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-5 and 7-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by de la Rama et al., (US 20110118726; hereinafter de la Rama).
Regarding claim 1, de la Rama (general catheter shown in Fig.1 and specific basket catheter embodiment shown in Fig. 4) discloses a basket catheter (10) comprising: an elongated catheter shaft (12) including a proximal end (not shown, but at the opposite end of shaft 12 from distal end 14) and a distal end (14); a flexible basket catheter (20) comprising a basket electrode assembly (Fig. 4, element 80) having a proximal end (Fig. 1, element 26), a distal end (Fig.1, element 28), and a plurality of splines (Fig. 1, element 24), the flexible basket catheter (20) coupled to the distal end of the catheter shaft (12) and configured to conform to tissue when extended into a deployed configuration (shown in Fig. 4b); at least one electrode (82) mounted to each of the plurality of splines (24), wherein each of the at least one electrodes (82) is configured for ablating the tissue; and an adjusting member (85) between the distal end of the basket electrode assembly (80) and the proximal end of the catheter shaft (12) for transitioning the basket electrode assembly (80) between the deployed configuration (shown in Fig. 4b) and a contracted configuration (shown in Fig. 4a), wherein, in the contracted configuration (shown in Fig. 4a), the plurality of splines (24) are configured to nest within adjacent splines (24), ([0029]-[0030], [0039], [0041]).
Regarding claim 2, de la Rama (general catheter shown in Fig.1 and specific basket catheter embodiment shown in Fig. 4) further discloses wherein each of the plurality of splines (24) comprises a proximal portion (26) and a distal portion (28), wherein the at least one electrode (82) is mounted to the distal portion of the respective spline (24) of the plurality of splines (24), ([0029]-[0030], [0039], [0041]).
Regarding claim 3, de la Rama (general catheter shown in Fig.1 and specific basket catheter embodiment shown in Fig. 4) further discloses wherein, in the deployed configuration, the distal portions of each of the plurality of splines are arranged to such that each of the at least one electrodes contacts tissue for ablating the tissue.
Regarding claim 4, de la Rama (general catheter shown in Fig.1 and specific basket catheter embodiment shown in Fig. 4) further discloses wherein each of the at least one electrodes are configured to deliver radiofrequency ablation energy to the tissue.
Regarding claim 5, de la Rama (general catheter shown in Fig.1 and specific basket catheter embodiment shown in Fig. 4) further discloses wherein the radiofrequency ablation is unipolar ablation energy or bipolar ablation energy.
Regarding claim 7, de la Rama (general catheter shown in Fig.1 and specific basket catheter embodiment shown in Fig. 4) further discloses wherein each of the plurality of splines include a plurality of pads that extend transverse to a length of the splines and are configured the at least one electrode, wherein the pads on adjacent splines are longitudinally offset to facilitate interleaving of the pads when the flexible basket catheter is actuated in the contracted configuration.
Regarding claim 8, de la Rama (general catheter shown in Fig.1 and specific basket catheter embodiment shown in Fig. 4) further discloses wherein each of the splines is substantially saw- tooth shaped.
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.
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over de la Rama as applied to claim 1 above, and further in view of Marecki et al., (US 20150351652; hereinafter Marecki).
Regarding claim 6, de la Rama discloses the basket catheter of claim 1, but fails to disclose wherein the splines comprises flexible electronic circuits that are communicatively and mechanically coupled to the each of the at least one electrodes. However, Marecki (Figures 1 and 6) teaches a basket catheter (10), wherein the splines (60) comprises flexible electronic circuits (82, 84) that are communicatively and mechanically coupled to at least one electrode ([0078], [0096]-[0097]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify de la Rama to include the splines comprising flexible electronic circuits that are communicatively and mechanically coupled to the each of the at least one electrodes because the modification would provide spline electronics which are configured to conform to a surface of a target area while maintaining connectivity ([0079], [0096]).
Claim(s) 9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over de la Rama as applied to claim 1 above, and further in view of Auerbach et al., (US 20180085064; hereinafter Auerbach).
Regarding claims 9 and 12, de la Rama discloses the basket catheter of claim 1, but fails to disclose wherein each of the plurality of splines comprises a plurality of electrodes, further wherein one or more of the plurality of electrodes is configured for mapping and the other of the plurality of electrodes are configured to deliver ablation energy to the tissue. However, Auerbach (Figures 1-2) teaches a basket catheter (22), ([0020]), wherein each of a plurality of splines (62) comprises a plurality of electrodes (64), further wherein one or more of the plurality of electrodes (for example, the top group of electrodes 64 shown in Fig. 2) is configured for mapping and the other of the plurality of electrodes (for example, the bottom group of electrodes 64 shown in Fig. 2) are configured to deliver ablation energy to the tissue ([0029]: each spline may include a group of mapping electrodes and a group of ablation electrodes). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify de la Rama to include each of the plurality of splines comprising a plurality of electrodes, wherein one or more of the plurality of electrodes is configured for mapping and the other of the plurality of electrodes are configured to deliver ablation energy to the tissue, as taught by Auerbach, because the modification would enable diagnostic and therapeutic functionality in one device (Auerbach; [0020]).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over de la Rama/Auerbach, as applied to claim 9 above, and further in view of Marecki.
Regarding claims 10-11, de la Rama/Auerbach teaches the basket catheter of claim 9, but fails to teach wherein the plurality of electrodes are arranged in at least two columns along the respective spline, further wherein the plurality of electrodes are arranged in an offset pattern in the at least two columns along the respective spline. However, Marecki (Figures 5B) teaches a basket catheter (10), wherein a plurality of electrodes (74) are arranged in at least two columns (a, b) along a respective spline (60), further wherein the plurality of electrodes (74) are arranged in an offset pattern in the at least two columns (a, b) along the respective spline (60), ([0086]-[0090]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify de la Rama/Auerbach to include the plurality of electrodes are arranged in at least two columns along the respective spline, wherein the plurality of electrodes are arranged in an offset pattern in the at least two columns along the respective spline, as taught by Marecki, because the modification would reduce impedance and noise issues (Marecki; [0089]-[0090]).
Claim(s) 13-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over de la Rama/Auerbach, as applied to claim 9 above, and further in view of de la Rama et al., (US 20150374252; hereinafter R2).
Regarding claim 13, de la Rama/Auerbach teaches the basket catheter of claim 9, but fails to teach wherein each of the plurality of electrodes are grouped into cliques of three or more electrodes and each clique of electrodes is configured to sample electrical characteristics of contacted tissue in at least two substantially transverse directions. However, R2 (Figures 10-16) teaches a catheter including a linear element (10E), wherein each of a plurality of electrodes (18) are grouped into cliques of three or more electrodes (any group of three or more adjacent electrodes) and each clique of electrodes is configured to sample electrical characteristics of contacted tissue in at least two substantially transverse directions ([0064], [0073]-[0079]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify de la Rama/Auerbach to include each of the plurality of electrodes grouped into cliques of three or more electrodes and each clique of electrodes configured to sample electrical characteristics of contacted tissue in at least two substantially transverse directions, as taught by R2, because the modification would provide more accurate mapping and ablation (R2; [0106]).
Regarding claim 14, de la Rama/Auerbach/R2 further teaches wherein a center-to-center distance between the electrodes (R2; 18) in each clique is between 0.5 and 4 millimeters (R2; [0064], [0073]-[0079]).
Regarding claim 15, de la Rama/Auerbach/R2 further teaches wherein an edge-to-edge distance between at least two pairs of electrodes (R2; 18) within each clique is equal (R2; [0064], [0073]-[0079]: longitudinal spacing between adjacent electrodes SC = circumferential spacing between adjacent electrodes SL, so the distance between each electrode within the cliques will be equal since the electrodes in a clique are always adjacent to one another).
Regarding claim 16, de la Rama/Auerbach/R2 further teaches wherein an center-to-center distance between at least two pairs of electrodes (R2; 18) within each clique is equal (R2; [0064], [0073]-[0079]: longitudinal spacing between adjacent electrodes SC = circumferential spacing between adjacent electrodes SL, so the distance between each electrode within the cliques will be equal since the electrodes in a clique are always adjacent to one another).
Regarding claim 17, de la Rama/Auerbach/R2 further teaches wherein each of the electrodes within of the cliques of three or more electrodes (R2; 18) form an isosceles triangle with a vertex angle between 30° and 140° (R2; [0064], [0073]-[0079]: an example of a clique forming an isosceles triangle is shown below in annotated Figure 12 of R2).
PNG
media_image1.png
275
421
media_image1.png
Greyscale
Annotated Figure 12 of R2
Regarding claim 18, de la Rama/Auerbach/R2 further teaches wherein the cliques of three or more electrodes form a right triangle (R2; [0064], [0073]-[0079]: an example of a clique forming a right triangle is shown above in annotated Figure 12 of R2).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over de la Rama/Auerbach, as applied to claim 9 above, and further in view of Afonso et al., (US 20130274582; hereinafter Auerbach).
Regarding claim 19, de la Rama/Auerbach teaches the basket catheter of claim 9, but fails to teach wherein the plurality of electrodes are spot electrodes. However, Afonso (Figures 1 and 5) teaches a catheter (28) comprising a plurality of spot electrodes (30B), ([0058]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the plurality of electrodes taught by de la Rama/Auerbach with the plurality of spot electrodes taught by Afonso since both plurality of electrodes perform the same function of providing an electrical contact with a target area and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B).
Regarding claim 20, de la Rama/Auerbach teaches the basket catheter of claim 9, but fails to teach wherein the plurality of electrodes are ring electrodes. However, Afonso (Figures 1 and 5) teaches a catheter (28) comprising a plurality of ring electrodes (30A/C), ([0058]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the plurality of electrodes taught by de la Rama/Auerbach with the plurality of ring electrodes taught by Afonso since both plurality of electrodes perform the same function of providing an electrical contact with a target area and it has been held that substituting parts of an invention which perform the same function involves only routine skill in the art. MPEP 2144.06 (II)(B).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE PREMRAJ whose telephone number is (571)272-8013. The examiner can normally be reached Monday - Friday: 8:00 AM - 5:00 PM.
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, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794
