DETAILED ACTION
Applicant's amendments and remarks, filed 6/23/26, are fully acknowledged by the Examiner. Currently, claims 1-3 and 5-20 are pending with claim 4 canceled, and claims 1, 16, and 19 amended. The following is a complete response to the 6/23/26 communication.
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 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.
Claim(s) 1-10 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urbanski (US 2021/0228268).
Regarding claim 1, Urbanski teaches a transseptal access and crossing system for perforating a septum in a patient's heart, the system comprising:
an outer guide member having a distal end and a proximal hub (sheath 20 and hub 21), and a lumen extending therebetween (lumen within 20 through 21);
a radiofrequency perforation device having a distal tip and a proximal portion (RF puncture device 110 as in par. [0094]), the radiofrequency perforation device being configured to translate within the lumen (as in par. [0117], RF guidewire 10 analogous to 110 as in par. [0094]);
the radiofrequency perforation device proximal portion comprising a distal marker, an intermediate marker, and a proximal marker (markers 117 and 116 as distal, intermediate, and proximal markers as in par. [0131]);
wherein each of the distal marker, the intermediate marker, and the proximal marker are positioned and sized to provide an indication of the location of the distal tip of the radiofrequency perforation device in relationship to the distal end of the outer guide member (markers to indicate location of puncture device as in par. [0129], [0138] relative to supporting member), and wherein the distal marker, the intermediate marker, and the proximal marker include contrasting colors (at least par. [0140] different colors to distinguish the markers),wherein the distal marker is positioned to indicate that the distal tip is retracted within the outer guide member (marker to indicate position relative to the supporting member as in par. [0129]).Urbanski is not explicit regarding a proximal edge of the distal marker is positioned to indicated that the distal tip is aligned with the distal end of the outer guide member and a distal edge of the proximal marker is positioned to indicate that the distal tip is advanced beyond the distal end of the outer guide member by a desired length.However, Urbanski teaches an embodiment of Fig. 5 where the position of the distal marker and proximal marker positioned to indicate relative positioning of the distal tip with respect to the outer guide member, (Fig. 5a-c with proximal edge of 104 aligning with 142 to indicate positioning of the puncture device and supporting member, and the proximal marker positioning to indicate the distal tip as in par. [0138]).It would have been obvious to one of ordinary skill in the art that the markers mean particular positionings of the distal tip with respect to the outer guide member, as in Urbanski, allowing for determining location of the distal tip. One of ordinary skill in the art, through routine experimentation, would arrive at the positioning of the claimed markers as a matter of determining what part of a marker best indicates a position of the device.
Regarding claim 2, Urbanski teaches wherein the distal marker, the intermediate marker, and the proximal marker are asymmetrically positioned along the proximal portion (Fig. 1Hii).
Regarding claim 3, Urbanski teaches wherein the distal marker, the intermediate marker, and the proximal marker are symmetrically positioned along the proximal portion (par. [0140] spaced).
Regarding claim 5, Urbanski teaches wherein a center of the intermediate marker is configured for gripping (tactile marker as in par. [0129]).
Regarding claim 6, Urbanski is not explicit regarding:
a distal intermediate marker and a proximal intermediate marker, the distal intermediate marker and
the proximal intermediate marker being configured to provide an indication of the distal tip of the radiofrequency perforation device being advanced out of the outer guide member.
However, Urbanski teaches a varying amount of markers (par. [0131], with 0, 1, 2 intermediate markers).
It would have been obvious to one of ordinary skill in the art to modify Urbanski with the five markers, as different quantities of markers would allow for granularity in assessing the relative positioning between the puncture device and the sheath (par. [0020]).
Regarding claim 7, Urbanski teaches wherein the outer guide member comprises a sheath (sheath 20).
Regarding claim 8, Urbanski teaches wherein the outer guide member includes a surface configured to align with a portion of the distal marker, the proximal marker, and the intermediate marker (par. [0020] marker relative to sheath).
Regarding claim 9, Urbanski teaches further comprising: one or more tactile markers located on the radiofrequency perforation device proximal portion (tactile markers on the proximal end of the puncture device as in par. [0020]).
Regarding claim 10, Urbanski teaches wherein the one or more tactile markers includes one or more recessed or raised features (par. [0132] tactility via raised PTFE layer).
Regarding claim 12, Urbanski teaches wherein the distal marker and the intermediate marker have different lengths (at least Fig. 1Hii with two different lengths of distal marker 117 and intermediate marker 117).
Regarding claim 15, Urbanski teaches wherein the radiofrequency perforation device does not include a handle coupled to the proximal portion (no handle on puncture device as in par. [0129]).
Regarding claim 16, Urbanski teaches a transseptal access and crossing device used in combination with an outer guide member (sheath 20) having a distal end, a proximal hub, and a lumen extending therebetween for perforating a septum in a patient's heart, the system comprising:
an elongate member having a distal tip and a proximal portion (110);
the proximal portion comprising a distal marker, an intermediate marker, and a proximal marker (markers 116, 117 as in par. [0131]);
wherein the distal marker, the intermediate marker, and the proximal marker are configured to provide an indication of the location of the elongate member in relationship to the outer guide member (markers to indicate location of puncture device as in par. [0129], [0138] relative to supporting member), wherein the distal marker is positioned to indicate that the distal tip is retracted within the outer guide member (marker to indicate position relative to the supporting member as in par. [0129]),and wherein the distal marker, the intermediate marker, and the proximal marker include contrasting colors (at least par. [0140] different colors to distinguish the markers).Urbanski is not explicit regarding a proximal edge of the distal marker is positioned to indicated that the distal tip is aligned with the distal end of the outer guide member and a distal edge of the proximal marker is positioned to indicate that the distal tip is advanced beyond the distal end of the outer guide member by a desired length.However, Urbanski teaches an embodiment of Fig. 5 where the position of the distal marker and proximal marker positioned to indicate relative positioning of the distal tip with respect to the outer guide member, (Fig. 5a-c with proximal edge of 104 aligning with 142 to indicate positioning of the puncture device and supporting member, and the proximal marker positioning to indicate the distal tip as in par. [0138]).It would have been obvious to one of ordinary skill in the art that the markers mean particular positionings of the distal tip with respect to the outer guide member, as in Urbanski, allowing for determining location of the distal tip. One of ordinary skill in the art, through routine experimentation, would arrive at the positioning of the claimed markers as a matter of determining what part of a marker best indicates a position of the device.
Regarding claim 17, Urbanski teaches wherein the distal marker, the intermediate marker, and the proximal marker are asymmetrically positioned along the proximal portion (at last Fig. 1H, with 117 with different thicknesses).
Regarding claim 18, Urbanski teaches wherein the distal marker, the intermediate marker, and the proximal marker are symmetrically positioned along the proximal portion (par. [0140] spaced).
Regarding claim 19, Urbanski teaches a transseptal access and crossing system for perforating a septum in a patient's heart, the system comprising:
an elongate member having a distal tip and a proximal portion (110 with a distal tip 114 and proximal section proximal to the distal tip);
the proximal portion comprising a plurality of markers (par. [0129]);
wherein the marks are configured to provide an indication of the location of the inner member in relationship to an outer member (markers to indicate location of puncture device as in par. [0129], [0138] relative to supporting member).
Urbanski is not specific regarding the proximal portion comprising a distal marker, a distal intermediate marker, an intermediate marker, a proximal intermediate marker, and a proximal marker, wherein the distal and proximal intermediate markers indicate that the distal tip is advanced out of the outer guide member.
However, Urbanski teaches a varying amount of markers (par. [0131], with 0, 1, 2 intermediate markers), and positioning of markers to indicate the position of the distal tip relative to the outer guide member (Fig. 5a-c).
It would have been obvious to one of ordinary skill in the art to modify Urbanski with the five markers, as different quantities of markers would allow for granularity in assessing the relative positioning between the puncture device and the sheath (par. [0020]). And allowing for the markers to indicate tip placement relative to the outer member (par. [0138]).
Regarding claim 20, the combination teaches wherein the distal marker, the distal intermediate marker, the intermediate marker, the proximal intermediate marker, and the proximal marker are symmetrically positioned along the proximal portion (par. [0140] spaced).
Claim(s) 11, 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Urbanski in view of Yang (US 2020/0205845).
Regarding claim 11, Urbanski is not explicit wherein the distal marker and the intermediate marker have a same length.
However, Yang teaches marker bands for detecting positions of a tubular body (claim 8, marker band length of 5 mm).
It would have been obvious to one of ordinary skill in the art to modify Urbanski with the marker lengths as in Yang, as known same marker lengths to determine locations of an elongate device.
Regarding claim 13, Urbanski is not explicit wherein a length of the distal marker, the intermediate marker, or the proximal marker is in the range of 1 mm to 8 mm.
However, Yang teaches marker bands for detecting positions of a tubular body (claim 8, marker band length of 5 mm).
It would have been obvious to one of ordinary skill in the art to modify Urbanski with the marker lengths as in Yang, as known marker lengths to determine locations of an elongate device.
Regarding claim 14, Urbanski is not explicit wherein a length of the distal marker, the intermediate marker, or the proximal marker is in the range of 4 mm to 12 mm.
However, Yang teaches marker bands for detecting positions of a tubular body (claim 8, marker band length of 5 mm).
It would have been obvious to one of ordinary skill in the art to modify Urbanski with the marker lengths as in Yang, as known marker lengths to determine locations of an elongate device.
Response to Arguments
Applicant’s arguments, see the remarks, filed 6/23/26, with respect to the rejection(s) of claim(s) 1-20 under 35 USC 102(a)(1) or 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Urbanski as a 103 rejection.
Applicant further argues that one would not modify Urbanski with Yang with the marker lengths. However, marker lengths along a catheter are taught by Yang, and the lengths of Yang would be known lengths that can be identified by a user. The length of the marker of Yang is within the ranges given in the claims.
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 BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 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, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
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