DETAILED ACTION
This action is pursuant to the claims filed on July 13, 2023. Claims 1-20 are pending. Claims 18-20 is/are withdrawn. A first action on the merits of claims 1-17 is as follows.
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 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.
Election/Restrictions
Applicant’s election without traverse of Group I directed to medical dilation in the reply filed on December 8, 2025 is acknowledged.
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.
(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 1-3, 10-11, and 16 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Moak et al. (hereinafter ‘Moak’, WO 2018/165277, see IDS).
In regards to independent claim 1, Moak discloses a medical dilator (a dilator 120 of an apparatus 100 in Fig. 2) comprising:
an elongate member having a proximal end portion, an opposed distal end portion (pg. 5, ln. 24-25: “[t]he dilator includes an outer surface, a proximal end, a distal end terminating in a tapered distal tip”), and
a lumen (lumen for receiving a retractable transseptal needle 130) extending through the elongate member from the proximal end portion of the distal end portion (pg. 5, ln. 25-26: “a lumen extending between the proximal and distal ends of the dilator”);
a dilating tip (tapered distal tip shown in Fig. 2) at the distal end portion, the dilating tip having first end of enlarged cross-sectional area and tapering going in the distal direction to a second end of reduced cross-sectional area (the varying cross-sectional area is inherent to the tapered distal tip shown in Fig. 2);
at least a first electrode (electrode 140a) associated with the dilating tip (electrode 140a disposed on the tapering section of the dilator 120 in Fig. 2); and
an electrical conductor (wire 145a) electrically connected to the first electrode (wire 145a extends along the dilator 120 to connect to the electrode 140a, col. 8, ln. 14-15) and extending proximally from the first electrode towards the proximal end portion for electrical connection with an electroanatomical mapping system (pg. 7, ln. 24-27: “distal and proximal electrode pairs 140a/140b… for measuring electrophysiological activity while simultaneously recording its position in space to generate a three-dimensional map of the cardiac chambers); and
an electroanatomical mapping system (pg. 7, ln. 1-8: a guidance system configured to measure electrophysiological activity via the electrode pairs 140a/104b and record its position in space to generate a three dimensional map of the cardiac chamber) electrically connectable to the electrically conductor and configured to receive an electroanatomical mapping signal from the electrode and determine a location of the dilating tip based on the electroanatomical mapping signal (pg. 9, ln. 29-pg. 10, ln. 12: a guidance system configured to measure electrophysiological activity via the electrode pairs 140a/104b and record its position in space to generate a three dimensional map of the cardiac chamber).
In regards to claim 2, Moak further discloses the first electrode is positioned between the first end of the dilating tip and the second end of the distal tip (the electrode 140a is disposed between the maximum cross-sectional area and the minimum cross-sectional area of the tapering distal section of the dilator 120 as shown in Fig. 2).
In regards to claim 3, Moak further discloses wherein the first electrode is positioned proximal of the first end of the dilating tip (the electrode 140a is disposed between the maximum cross-sectional area which is the first end, and the minimum cross-sectional area of the tapering distal section; therefore, the electrode 140a is adjacent to the distal end of the dilator 120 as shown in Fig. 2).
In regards to claim 10, Moak further discloses wherein the first electrode is removable from the elongate member (the examiner notes that ‘removable’ limitation is not the same as removeably attachable, therefore, the electrode is capable of being removed permanently from the elongate member of the dialator).
In regards to claim 11, Moak further discloses comprising a second electrode (electrode 140b in Fig. 2) mounted to the elongate member and spaced from the first electrode (electrode 140b is spaced apart from the first electrode 140a in Fig. 2).
In regards to claim 16, Moak discloses a medical dilation system, comprising:
a medical dilator (apparatus 100 comprising dilator 120 in Fig. 2) comprising:
an elongate member having a proximal end portion, an opposed distal end portion (pg. 5, ln. 24-25: “[t]he dilator includes an outer surface, a proximal end, a distal end terminating in a tapered distal tip”), and
a lumen extending through the elongate member from the proximal end portion of the distal end portion (pg. 5, ln. 25-26: “a lumen extending between the proximal and distal ends of the dilator”);
a dilating tip at the distal end portion (tapered distal tip shown in Fig. 2), the dilating tip having first end of enlarged cross-sectional area and tapering going in the distal direction to a second end of reduced cross-sectional area (the varying cross-sectional area is inherent to the tapered distal tip shown in Fig. 2);
at least a first electrode associated with the dilating tip (electrode 140a in Fig. 2); and
an electrical conductor electrically connected to the first electrode (wire 145a extends along the dilator 120 to connect to the electrode 140a, col. 8, ln. 14-15) and extending proximally from the first electrode towards the proximal end portion for electrical connection with an electroanatomical mapping system (pg. 7, ln. 24-27: “distal and proximal electrode pairs 140a/140b… for measuring electrophysiological activity while simultaneously recording its position in space to generate a three-dimensional map of the cardiac chambers); and
an electroanatomical mapping system (pg. 7, ln. 1-8: a guidance system configured to measure electrophysiological activity via the electrode pairs 140a/104b and record its position in space to generate a three dimensional map of the cardiac chamber) electrically connectable to the electrically conductor and configured to receive an electroanatomical mapping signal from the electrode and determine a location of the dilating tip based on the electroanatomical mapping signal (pg. 9, ln. 29-pg. 10, lin. 12: a guidance system configured to measure electrophysiological activity via the electrode pairs 140a/104b and record its position in space to generate a three dimensional map of the cardiac chamber).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 4-5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Moak as applied to claim 1 above, and further in view of Brucker et al. (hereinafter ‘Brucker’, U.S. Pat. No. 5,500,012).
In regard to claims 4-5 and 12, Moak discloses the invention substantially as claimed in claim 1 and discussed above.
However, Moak does not disclose wherein the dilating tip has a tip circumferential outer surface having a circumferential groove defined therein, and the first electrode is annular and is seated in the groove, wherein the first electrode has an electrode outer surface, and the electrode outer surface is flush with the tip circumferential outer surface.
Brucker teaches a catheter (a catheter 100 in Fig. 10) comprising a plurality of electrodes (electrodes 102 and 104 in Fig. 10) being disposed in a circumferential groove defined along an outer surface of the catheter and each of the electrodes (electrodes 102 and 104) has an electrode outer surface which is flushed with the tip circumferential outer surface (Fig. 10 shows that electrodes 102 and 104 are embedded along its respective groove of the elongate member of the catheter 100 so that the electrodes and the outer surface of the catheter are flushed). Note that the circumference groove inherently comprises a proximal piece having a distal-facing shoulder surface (the proximal wall of the groove configured to abut the proximal-most circumferential face of the electrode), a neck extending distally from the shoulder face (the lower surface of the groove extending from the proximal wall of the groove towards distal portion), and a distal piece (the distal wall of the groove configured to abut the distal-most circumferential face of the electrode). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the first electrode of Moak, and embed the first electrode into the dilator so that the outer surface of the first electrode and the outer surface of the dilator are flushed as taught by Bruker, as doing so involves routine skill in the art and provide a smooth surface along the dilator distal tip.
Claims 6 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Moak as applied to claim 1 above, in view of Krishnan (U.S. PGPub. No. 2008/0103400) and further in view of O’Dea et al. (hereinafter ‘O’ Dea’, U.S. PGPub. No. 2010/0228202).
In regard to claims 6 and 13-14, Moak discloses the invention substantially as claimed in claim 1 and discussed above.
However, Moak does not disclose wherein the dilating tip has a tip circumferential outer surface, a tip circumferential inner surface, and a tip sidewall extending between the tip circumferential inner surface and the circumferential outer surface, the electrical conductor extends from the first electrode through the tip sidewall.
Kirshnan teaches a dilator (dilator 50 in Figs. 7-8) comprising a pair of electrodes (electrodes 65 and 66) where one of the electrodes (electrode 65) forms a distal tip (70) of the dilator ([0081]). Note that an outer surface of the dilator tip (dilator tip 70 in Fig. 8) defines a tip circumferential outer surface, an inner surface of the (inner surface of dilator tip 70 facing the guidewire lumen) defines a tip circumferential inner surface and a tip sidewall is the thickness of the dilator tip (70). Fig. 8 illustrates a conductor (electrical lead 73) extending from the electrode (65) through a side will (elongate member forming the dilator 52). Kirshnan explains that the electrode (65) at the distal tip is used to detect unipolar electrograms to locate fossa ovalis ([0081]). Note that the electrode (65) is formed from a metallic member having a first section (proximal portion of the electrode 65) which abuts a distal-most end of the elongate member (distal end of the sleeve of the dilator 52 adjacent to the proximal end of the electrode 65) while a second section provides the first electrode and the dilating tip (the distal portion of the first electrode 65 forming the distal-most end of the dilator 52). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the position of the electrodes of Moak such that the distal electrode forms the dilating tip as taught by Kirshman, as doing so allows for the electrode to come to contact and locate fossa ovalis via unipolar electrocardiogram during transseptal procedures ([0081]).
However, Moak/Kirshnan combination does not disclose that the electrical conductor which extends from the first electrode through the sidewall extends into the lumen.
O’Dea discloses an internal arrangement in which an electrical conductor (wire 10 in Fig. 3) connected to an electrode (electrode 5) extends through a sidewall of an elongate member (extending through an opening 12 of an elongate member 6) and into a main lumen (lumen 9) so that the conductor wire extends to a proximal end of a medical device (30). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the arrangement of the electrical conductor which is embedded in the elongate member of Moak/Kirshnan combination but passes through the elongate member into the lumen as taught by O’Dea, as doing so is merely one of two ways one of ordinary skill in the art would choose from to route electrical conductor(s) within a medical elongate member (e.g. embed along the elongate member or disposed within a lumen).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Moak as applied to claim 1 above, in view of Kirshnan.
In regards to claim 7, Moak discloses the invention substantially as claimed in claim 1 and discussed above.
Moak does not disclose wherein the elongate member has a circumferential outer surface, a circumferential inner surface, and a sidewall extending along the length of the elongate member between the circumferential inner surface and the circumferential outer surface, and the electrical conductor is embedded in the sidewall and extends from the first electrode to the proximal end portion.
Kirshnan teaches a dilator (dilator 50 in Figs. 7-8) formed from an insulative sleeve (elongate member 52 of the dilator 50 in Figs. 7-8) which define a circumferential outer surface (outer surface of the elongate member 52), a circumferential inner surface (inner surface of the elongate member 52 facing the lumen (not labeled) and a sidewall extending along the length of the elongate member between the circumferential inner surface and the circumferential outer surface (the radial thickness of the elongate member 52). Kirshnan further discloses a pair of electrodes (electrodes 65 and 66) where one of the electrodes (electrode 65) forms a distal tip (70) of the dilator ([0081]) and Fig. 8 specifically illustrates a conductor (electrical lead 73) extending from the electrode (65) and embedded in the sidewall (lead 73 embedded in member 73). Kirshnan explains that the electrode (65) is used to detect unipolar electrograms to locate fossa ovalis ([0081]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the position of the electrodes of Moak such that the distal electrode forms the dilating tip as taught by Kirshman, as doing so allows detection of unipolar electrograms to locate fossa ovalis ([0081]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Moak and Kirshnan as applied to claim 7 above, and further in view of O’Dea.
In regards to claim 8, Moak/Kirshnan combination discloses the invention substantially as claimed in claim 7/1 and discussed above.
However, Moak/Kirshnan combination does not disclose that the circumferential outer surface has a longitudinal groove defined therein and extending from the first electrode to the proximal end portion and wherein the electrical conductor is seated in the longitudinal groove.
O’Dea discloses an internal arrangement in which an electrical conductor (wire 10 in Fig. 4) connected to an electrode (electrode 5) extends through a sidewall of an elongate member (extending through an opening 12 of an elongate member 6) and into a main lumen (lumen 9) so that the conductor wire extends to a proximal end of a medical device (30). Specifically, O’Dea explains that the skived end of the electrical conductor is accommodated in longitudinally extending groove (51) which extend longitudinally from the corresponding radial communicating opening (12) of the elongate member (6), ([0126]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the arrangement of the electrical conductor of Moak/Kirshnan combination so that a skived end of the electrical conductor extends in a groove defined along a surface of the elongate member and routed through an opening of the elongate member into a lumen as taught by O’Dea, as doing so is merely one of two ways one of ordinary skill in the art would choose from to route electrical conductor(s) within a medical elongate member (e.g. embed along the elongate member or disposed within a lumen). Furthermore, securing the skived ends of the electrical conductor into the groove of the elongate surface allows for a better electrical contact between the electrical conductor and the electrode ([0126]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Moak and Kirshnan as applied to claim 7/1 above, and further in view of Howat et al. (hereinafter ‘Howat’, U.S. PGPub. No. 2010/0217257).
In regards to claim 7, Moak/Kirshnan combination discloses the invention substantially as claimed in claim 1 and discussed above.
However, Moak/Kirshnan combination does not disclose wherein the elongate member comprises an outer tube defining the circumferential outer surface, and an inner liner within the outer tube and defining the circumferential inner surface, and wherein the electrical conductor is a tubular braid and is positioned between the outer tube and the inner liner.
Howat teaches a catheter comprising an elongate member (shaft 12) which includes an outer tube (outer layer in Fig. 8), an inner layer (26), and a braid assembly (28) which serves as electrical conductor between electrodes and an external device ([0032],[0051]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the elongate member of Moak/Kirshnan combination to embed a conductive braid between outer tube and inner liner as taught by Howat so that the braid assembly/electrical conductor is embedded in the sidewall and extends from the electrode to the proximal end portion of the dilator as doing so allows for sufficient number of articulations without causing tears that lead to electrical damages or shorts of the electrical conductor ([0020]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Moak as applied to claim 1 above, and further in view of Hartley et al. (hereinafter ‘Hartley’, U.S. Pat. No. 7,048,733).
In regards to claim 15, Moak discloses the invention substantially as claimed in claim 1 and discussed above.
However, Moak does not disclose the first electrode is radiopaque or has an echogenic profile.
Hartley teaches forming an electrode from an electrically conductive and radiopaque material to provide location information of the electrode during an transseptal access (col. 4, ln. 48-58). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the electrode of Moak and formed with radiopaque material as taught by Hartley so that the electrode can be detected via imaging during transseptal access (col. 4, ln. 48-58).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Moak as applied to claim 16 above, and further in view of Philips (NPL: Imaging beyond the catheter KODEX-EPD Cardiac Imaging and Mapping System).
In regards to claim 17, Moak discloses the invention substantially as claimed in claim 16 and discussed above.
However, Moak does not disclose wherein the electroanatomical mapping system is a dielectric open source system.
Philips teaches a cardiac imaging and mapping system called KODEX-EPD system that is an open platform or open source system which would work with any EP catheter and uses dielectric imaging to give physicians new insights to guide their intervention (pg. 2, para. 1). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Moak and incorporate the KODEX-EPD system, which is a dielectric open source system, as taught by Philips, as doing so works well with any EP catheters including Moak’s so that the dielectric imaging gives new insights during electroactivation mapping (pg. 2, para. 1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 1/21/2026