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.
Election/Restrictions
Applicant’s election without traverse of Species III in the reply filed on 06/17/2026 is acknowledged. Claims 1-10 are not drawn to Figure 28A. The claim very specifically details that the first structure includes a plurality of spline alignment features. Cited paragraph [0138] is what is being relied upon to withdraw claims 1-10 as each structure only includes one space or detent. It is a singular alignment feature per structure with respect to elected Figure 28A. Its clear that the plurality alignment features is meant to encompass the alignment posts (110) and alignment channels (112) of Figures 26.
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.
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.
Claims 11 and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Morency US Patent 6,119,030 (hereinafter Morency).
Regarding claim 11, Morency discloses a basket catheter, comprising: a catheter shaft having a proximal end, a distal end, and defining a longitudinal axis therebetween (column 5 lines 4-6); a basket electrode assembly extending distally from the distal end of the catheter shaft, the basket electrode assembly comprising: a plurality of splines (14), each of the plurality of splines comprising a distal portion, a medial portion, and a proximal portion (see Figures 1-2, 4 at splines 14); and a distal tip having a plurality of detents disposed along a sidewall thereof (elements 28/30 which are recesses that can lock in and prevent the movement of the splines, see also column 4 lines 58-60, the passage that is the detent extends from one sidewall of the tip to the other), wherein the distal portions of each of the plurality of splines is secured within a respective detent of the plurality of detents of the distal tip (Figures 3-4 which shows the tip of the spline 20/22 that interacts with the passage 28/30), wherein the distal portions of each of the plurality of splines are secured within the distal tip in a predetermined angular relationship via the plurality of detents (Figures 2 and 4 show the predetermined locations).
Regarding claims 18-19, Morency discloses that the first configuration is an expanded configuration (Figure 1), wherein the second configuration is a collapsed configuration (claim 1 which details having both configurations for during use and the other during implantation/removal as is known in the art).
Claim 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Danek et al. US Patent 7,425,212 (hereinafter Danek).
Regarding claim 20, Danek discloses a basket catheter, comprising: a catheter shaft (102) having a proximal end, a distal end, and defining a longitudinal axis therebetween catheter (102); a basket electrode assembly extending distally from the distal end of the catheter shaft (104), the basket electrode assembly comprising: a plurality of splines (106, see Figure 5B), each of the plurality of splines comprising a distal portion, a medial portion, and a proximal portion (Figures 5A-B at elements 106); and a distal tip coupled to the distal portions of each of the plurality of splines (118 in Figure 5B, better shown in Figures 6A-B at element 208), a first structure comprising an interior space for receiving distal portions of each of the plurality of splines (Figures 6A-B at element 218 which is a disc that includes multiple lumens within an interior) such that the distal portions of each of the plurality of splines are coupled to the distal tip in a predetermined angular relationship (Figures 5B, 6A-B which has the splines spaced apart given the lumens and with the square cross section would also keep them in an angular spacing); and a second structure (216), wherein the distal portions of each of the plurality of splines are secured relative to the second structure by the first structure (Figure 6A shows that the two work together to keep the splines 106 locked into place in the distal tip).
In the alternate, given the broadness of the limitations detailing the first structure and second structures, the tip of Danek could also be read in that the distal end of wire 212 which is soldered to the splines 106 is the second structure and element 216 would read as the first structure which includes an interior space given how the other elements are located within it, both structures sandwich the splines between them as per Figure 6A.
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 non-obviousness.
Claims 14-15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Morency in view of Danek.
Regarding claims 14-15 and 17, Morency discloses splines (106) and mentions its known to have splines with a rectangular cross-section and to be made of nitinol (column 1 lines 19-24), but does not detail that its own their own design. Danek explicitly details both aspects of splines (column 12 lines 41-50 where a rectangular cross section inherently includes an inner and outer facing surface). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the material and shaping of the splines as taught by Danek with the splines of Morency to ensure the splines do not permanently deform. The two cross sections (circular and rectilinear) are also art recognized equivalents and either could be used as desired.
Claims 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Morency in view of Kordis US Patent 5,893,847 (hereinafter Kordis).
Regarding claims 14-15 and 17, Morency discloses splines (106) and mentions its known to have splines with a rectangular cross-section and to be made of nitinol (column 1 lines 19-24), but does not detail that its own their own design. Kordis discloses a similar basket catheter that details both aspects of splines (Figures 10, 12-13 spline 22, as well as column 5 lines 61-63, column 6 lines 46-48). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the material and shaping of the splines as taught by Kordis with the splines of Morency to ensure the splines do not permanently deform. The two cross sections (circular and rectilinear) are also art recognized equivalents and either could be used as desired.
Regarding claim 16, Morency discloses that each of the plurality of splines comprises at least one electrode (column 5 lines 1-4), but doesn’t quite detail which way the electrodes are facing, and it isn’t inherent to every design to have electrodes facing outward. Kordis teaches splines with rectangular cross sections (above), that includes electrodes disclosed on an outer facing surface (electrodes 96 as per Figure 41, which has the electrodes disposed on the spline 22, though there are intervening layers; consisting of isn’t utilized so they can be present). It would have been obvious to the skilled artisan before the effective filing date to utilize the electrode location as taught by Kordis with the splines and electrodes of Morency as predictable results would have ensued (allowed the electrodes to be contact with tissue).
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.
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.
/BRIAN M ANTISKAY/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights