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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 15 October 2025 has been entered. Claim(s) 1 and 18-20 are currently amended. Claims 1-8 and 10-21 are pending in the application. Applicant’s amendments to the claims have overcome the rejections under 35 U.S.C. 112(b) previously set forth in the Final Office Action mailed 20 August 2025.
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.
Claims 1-5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Howard et al. (WO 2022/046777), hereinafter Howard, in view of Messing (US Patent No. 6,611,699).
Regarding claim 1, Howard teaches a transseptal apparatus (Fig. 2A: apparatus 102; par. 0099: “a tissue penetrating apparatus 102 in a transseptal crossing system”), comprising:
a body assembly (Fig. 2A: hub 114);
a shaft extending distally from the body assembly (Fig. 2A: tubular body 104), the shaft including: (i) a distal end (Fig. 2A: distal segment 207), and (ii) a lumen having a lumen diameter at a plane, the plane being longitudinally aligned with the distal end and perpendicular to the shaft axis (Fig. 2B: lumen 208); and
a tip member secured at the distal end of the shaft (Fig. 2D: functional tip region 110), the tip member and the distal end of the shaft being sized and configured to fit within a chamber of a heart of a human subject (par. 0099: “a tissue penetrating apparatus 102 in a transseptal crossing system […]. Apparatus 102 comprises an elongate tubular body 104 having a distal region 106, and a proximal region 108. Distal region 106 is adapted to be inserted within and along a lumen of a body of a patient, such as a patient's vasculature, and maneuverable therethrough to a desired location proximate material, such as tissue, to be perforated”),
the tip member including (i) a distal tip, the distal tip being configured to deliver electrical energy to tissue (Fig. 2D: dome-shaped energy delivery tip 112; par. 0103: “an energy delivery component and optionally also functions as an impedance and/or ECG measuring device. Functional tip region 110 comprises at least one energy delivery tip 112 made of a conductive and optionally radiopaque material, such as stainless steel, tungsten, platinum, or another metal”),
and (ii) at least one fluid passageway in fluid communication with the lumen of the shaft (Fig. 2D: opening 109; par. 0103: “Distal region 106 may contain at least one opening 109 which is in fluid communication with main lumen 208”),
at least a portion of the at least one fluid passageway of the tip member being positioned proximally in relation to the distal end of the shaft (Fig. 2D: a portion of the opening 109 positioned proximally in relation to the distal end of the shaft 104).
Howard does not explicitly teach a distal tip portion having a distal tip diameter that is smaller than the lumen diameter at the plane to thereby define a gap, the distal tip portion having the distal tip diameter extending distally beyond the distal end of the shaft and the plane such that the distal tip diameter is constant in a distal direction beyond the distal end of the shaft and the plane. However, in a related art, Messing teaches an RF catheter with a distal tip having a distal tip diameter that is smaller than the lumen diameter at the plane to thereby define a gap, the distal tip portion having the distal tip diameter extending distally beyond the distal end of the shaft and the plane such that the distal tip diameter is constant in a distal direction beyond the distal end of the shaft and the plane, which allows irrigating fluid to flow over the distal section to be cooled (Figs. 4A-4B: distal section 435, 480 with gaps 420, 495; col 7, lines 20-25: “an irrigating fluid, for example, a saline solution, flows through an irrigation channel 485 via flow path 490 and exits the electrode 470 through exit ports 495 extending through the distally facing surface 477 proximal the distal end 480. As the irrigating fluid exits the electrode 470, it is directed to flow over the straight distal end 480 to "cool itself."”).
Messing teaches the constant-diameter shape for the distal tip as an explicit alternative to a curved shape for the distal tip (col 7, lines 15-17: “a catheter tip electrode 470 may be shaped such that a distal section 480 is straight rather than mushroom-shaped, as illustrated in FIG. 4B”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Howard by providing a distal tip portion with a diameter smaller than the lumen diameter at the distal end of the shaft for fluid injection, as taught by Messing, in order for irrigating fluid to flow over the distal section to be cooled, as taught by Messing. It would further have been obvious to make the distal tip diameter constant in a distal direction beyond the distal end of the shaft and the plane, as taught by Messing, since a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claims 2-5, the combination teaches the device of claim 1 as described previously. Messing further teaches the tip member further including a body (Fig. 4B: distal section 480), the at least one fluid passageway including a recess formed in a side portion of the body, the recess including a distal portion and a proximal portion, the distal portion being positioned distally in relation to the distal end of the shaft, the proximal portion being positioned proximally in relation to the distal end of the shaft (Fig. 4B: exit ports 495 relative to tip electrode 470),
the at least one fluid passageway including at least two recesses angularly spaced apart from each other equidistantly about a central longitudinal axis extending through the body (Fig. 4B: angularly spaced exit ports 495),
the recess extending inwardly toward a central longitudinal axis extending through the body (Fig. 4B: exit ports 495 extending inwardly towards central longitudinal axis of the body).
Regarding claim 14, the combination teaches the device of claim 1 as described previously. Howard further teaches the distal tip comprising a dome shape (Fig. 2D: dome-shaped distal tip 112).
Claims 6-8 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Howard in view of Messing and further in view of Wang et al. (US Patent No. 8,348,937), hereinafter Wang.
Howard in view of Messing teaches the device of claim 1 as described previously but does not teach the following features:
the tip member comprising a distal body and a proximal body coupled with the distal body, the proximal body being secured to the shaft, the at least one fluid passageway being formed through the proximal body,
the proximal body comprising a disc shape
the lumen comprising an inner diameter, the distal body defining a first outer diameter, the proximal body defining a second outer diameter, the second outer diameter being sized to correspond with the inner diameter, the first outer diameter being smaller than the inner diameter such that the distal body defines a gap with the lumen
the proximal body being positioned within the lumen of the shaft
the at least one fluid passageway including a plurality of openings formed through the proximal body, the openings being angularly spaced apart from each other about a central longitudinal axis extending through the proximal body
the tip member further comprising an intermediate body interposed between the proximal body and the distal body, the intermediate body being narrower than the proximal and distal bodies
However, in an analogous art, Wang teaches an irrigated ablation catheter with the following features at its tip:
the tip member comprising a distal body and a proximal body coupled with the distal body (Fig. 1: distal electrode 108 coupled with proximal flow distributor 124), the proximal body being secured to the shaft (Fig. 1 and col 3, lines 66-67: “flow distributor 124 is bonded, or press fit, to an internal surface of middle tubular member 104”), the at least one fluid passageway being formed through the proximal body (Fig. 3: passageways 146; col 4, lines 51-55: “Passageways 146 allow fluid to flow from the space between inner tubular member 102 (shown in FIG. 1) and middle tubular member 104 (shown in FIG. 1) to an outside of catheter 100 (shown in FIG. 1) and cool electrode 108 (shown in FIG. 1)”),
the proximal body comprising a disc shape (Fig. 1: disc-shaped flow distributor 124)
the lumen comprising an inner diameter, the distal body defining a first outer diameter, the proximal body defining a second outer diameter, the second outer diameter being sized to correspond with the inner diameter (col 3, lines 66-67: “flow distributor 124 is bonded, or press fit, to an internal surface of middle tubular member 104;” examiner interprets a press fit as corresponding outer and inner diameters), the first outer diameter being smaller than the inner diameter such that the distal body defines a gap with the lumen (see Annotated Fig. 1)
the proximal body being positioned within the lumen of the shaft (Fig. 1 and col 3, lines 66-67: “flow distributor 124 is bonded, or press fit, to an internal surface of middle tubular member 104”)
the at least one fluid passageway including a plurality of openings formed through the proximal body, the openings being angularly spaced apart from each other about a central longitudinal axis extending through the proximal body (Fig. 3: plurality of passageways 146 angularly spaced apart from each other about a central longitudinal axis)
the tip member further comprising an intermediate body interposed between the proximal body and the distal body, the intermediate body being narrower than the proximal and distal bodies (see Second Annotated Figure 1)
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Annotated Figure 1
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Second Annotated Figure 1
Wang teaches that the disclosed configuration for fluid delivery provides cooling for an external surface of the electrode (col 1, lines 51-53) rather than internally, which can make accurate monitoring and ablation control more difficult (col 1, lines 32-39: “Open ablation catheters typically deliver the cooling fluid through open orifices on the electrode. The current open irrigated ablation catheters use the inner cavity of the electrode, or distal member, as a manifold to distribute saline solution. The saline flows directly through the open orifices of the distal electrode member. This direct flow through the distal electrode member lowers the temperature of the electrode member during operation, rendering accurate monitoring and control of the ablative process more difficult”). It would therefore have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Howard by using the fluid delivery configuration taught by Wang so that the external surface of the electrode is cooled, including the claimed features, in order to avoid the difficulty in accurate monitoring and ablation control that comes with delivering cooling fluid internally through the electrode, as taught by Wang.
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Howard in view of Messing and further in view of Kimmel et al. (US PGPub No. 2013/0304036), hereinafter Kimmel.
Regarding claim 15, Howard in view of Messing teaches the device of claim 1 as described previously. Howard further teaches wherein the body assembly includes a handle body (Fig. 2A: hub 114) but does not teach wherein the body assembly includes a depth stop member, the depth stop member being movable relative to the handle body and relative to the shaft, the depth stop member being configured to restrict a depth of insertion of the shaft into a guiding sheath based on a position of the depth stop member relative to the handle body and shaft. However, in an analogous art, Kimmel teaches a transseptal apparatus with a body assembly (Fig. 19A: assembly 930) including a depth stop member (Fig. 19A: adjustable puncture spacer 988), the depth stop member being movable relative to a handle body and relative to a shaft (Figs. 19A-19D: adjustable puncture spacer 988 movable in directions D, E, F relative to handle bodies 938 and 950 and shaft 932), the depth stop member being configured to restrict a depth of insertion of the shaft into a guiding sheath based on a position of the depth stop member relative to the handle body and shaft (Fig. 19A: puncture distance 992; par. 0082: “the adjustable puncture spacer 988 is slidable along proximal handle 950 to adjust a distance 992 between the distal handle 938 and the adjustable puncture spacer 988. […] the distance 992 determines a length of a puncture performed by the transseptal needle assembly 930 when the proximal handle 950 is slid forward with respect to the distal handle 938”).
Kimmel teaches that limiting the puncture distance using the disclosed mechanism decreases the risk of inadvertent exposure of the puncturing tip (par. 0090: “the present subject matter can decrease the risk of inadvertent exposure of the inner cannula tip”), which may potentially cause injury to the patient (par. 0075: “such a configuration limits potential injury to the patient due to inadvertent exposure of the patient to the inner cannula 34”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Howard by providing a depth stop member movable relative to the handle body and shaft and configured to restrict a depth of insertion of the shaft into a guiding sheath based on a position of the depth stop member relative to the handle body and shaft, as taught by Kimmel, in order to decrease risk of inadvertent exposure of the tip and thereby decrease risk of injury to the patient, as taught by Kimmel.
Regarding claim 16, the combination teaches the device of claim 15 as described previously. Kimmel further teaches the body assembly further comprising an actuator (Fig. 19A: locking button 990), the actuator being operable to drive movement of the depth stop member relative to the handle body and relative to the shaft, which allows the user to set a desired puncture length (par. 0082: “the physician or other user can set a desired puncture length by unlocking the adjustable puncture spacer 988 using the locking button 990, sliding the adjustable puncture spacer 988 to a desired distance 992, and locking the adjustable puncture spacer 988 using locking button 990”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the device of the combined reference by providing an actuator operable to drive movement of the depth stop member relative to the handle body and relative to the shaft, as taught by Kimmel, in order to allow the user to set a desired puncture length, as taught by Kimmel.
Regarding claim 17, the combination teaches the device of claim 15 as described previously. Howard further teaches the body assembly further comprising a port in fluid communication with the lumen of the shaft, the port being configured to couple with a tube (Fig. 2A: adapter 119 attached to hub 14; par. 0104: “An adapter 119 such as a Luer connector is attached to hub 114 as well, for placing external fluid sources or devices into communication with the central lumen 208”).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Howard in view of Roman et al. (US PGPub No. 2010/0057073), hereinafter Roman.
As laid out previously in the rejection of claims 1 and 14, Howard teaches a transseptal apparatus comprising:
a body assembly;
a shaft extending distally from the body assembly, the shaft including: (i) a distal end and (ii) a lumen; and
a tip member secured at the distal end of the shaft, the tip member and the distal end of the shaft being sized and configured to fit within a chamber of a heart of a human subject,
the tip member including a dome-shaped distal tip, the distal tip being configured to deliver electrical energy to tissue.
Howard further teaches a hollow interior region in fluid communication with the lumen of the shaft and an opening in direct communication to an outside environment (Fig. 2D: hollow passage and distal end of opening 109; par. 0103: “Distal region 106 may contain at least one opening 109 which is in fluid communication with main lumen 208”) but does not explicitly teach at least one opening is proximal to the dome-shaped distal tip and the hollow interior region extends distally beyond the at least one opening such that the hollow interior region is impermeable to fluid distally beyond the at least one opening. However, in a related art, Roman teaches an ablation catheter with a hollow, dome-shaped distal tip configured to deliver electrical energy to tissue with at least one opening proximal to the dome-shaped distal tip and in fluid communication with the hollow interior region, the hollow interior region extending distally beyond the at least one opening such that the hollow interior region is impermeable to fluid distally beyond the at least one opening, the at least one opening being in direct communication to an outside environment (Fig. 15: chamber 410 impermeable to fluid distally beyond opening 405b), to cool the tip electrode as well as neighboring tissue and blood (par. 0144: “As the cooling fluid passes through chamber 410, heat is absorbed from walls 410 of tip electrode 131. Fluid exiting second delivery tube 405b cools neighboring tissue, blood, and one or more shaft electrodes 121, such as the most proximate shaft electrode 121”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Howard by providing an opening proximal to the distal ship and a hollow interior region extending distally beyond the opening such that the hollow interior region is permeable to fluid distally beyond the opening, as taught by Roman, in order to cool the tip electrode as well as neighboring tissue and blood, as taught by Roman.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Howard in view of Kimmel and further in view of Richard (US PGPub No. 2010/0047737).
Regarding claim 19, Howard in view of Kimmel teaches the following features as laid out previously in the rejections of claims 1 and 15:
a transseptal apparatus comprising:
a body assembly, the body assembly including a handle body and a depth stop;
a shaft extending distally from the body assembly, the shaft including: (i) a distal end and (ii) a lumen; and
a tip member secured at the distal end of the shaft, the tip member and the distal end of the shaft being sized and configured to fit within a chamber of a heart of a human subject,
the tip member including (i) a distal tip, the distal tip being configured to deliver electrical energy to tissue, and (ii) at least one fluid passageway in fluid communication with the lumen of the shaft;
the depth stop being movable relative to the handle body and relative to the shaft, the depth stop being configured to restrict a depth of insertion of the shaft into a guiding sheath based on a position of the depth stop relative to the handle body and shaft.
Kimmel further teaches wherein the depth stop includes a detent (Figs. 19A-19D: locking button 990) and a flange (Figs. 19A-19D: adjustable puncture spacer 988), the detent being configured to retain a position of depth stop member relative to the handle body (par. 0082: “the locking button 990 locks the adjustable puncture spacer 988 at a desired distance 992 […] the physician or other user can set a desired puncture length by unlocking the adjustable puncture spacer 988 using the locking button 990, sliding the adjustable puncture spacer 988 to a desired distance 992, and locking the adjustable puncture spacer 988 using locking button 990”). The combination does not explicitly teach wherein the flange is a distal-most flange, the detent and the distal-most flange being monolithic with one another. However, in an analogous art, Richard teaches a depth stop for restricting a depth of insertion of an insertable element, including a detent (Fig. 3: transverse detents 17) and a distal-most flange (Figs. 1 and 3: abutment means 6), the detent and the distal-most flange being coupled with one another (Fig. 6 and par. 0078: “A connecting bridge 6c extends from the distal section 6b in order to connect it to the connecting section 7”), the detent being configured to retain a position of the depth stop relative to the handle body (Figs. 1 and 3: immobilizing means 16 and detents 17; par. 0081: “Immobilizing means 16 prevent any translation of the longitudinal connecting rod 7a in the guide sleeve 8a”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute one known element (a depth stop with a distal-most flange connected to the detent as shown in Richard) for another (a depth stop with separate flange and detent as shown in Kimmel), since the substitution would have yielded predictable results, namely, allowing the depth of insertion of the shaft to be restricted based on a position of the depth stop relative to the handle using a distal-most flange connected to the detent. It would further have been obvious to make the distal-most flange and the detent monolithic, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Regarding claim 20, the combination teaches the device of claim 19 as described previously. Kimmel teaches further comprising a guiding sheath (Fig. 19A: outer cannula 932 and corresponding Fig. 10A: outer cannula 32), the guiding sheath including an insertion port configured to receive a shaft and puncturing tip member (Figs. 10A-11B: inner cannula 34 insertable into outer cannula 32; Figs. 19A-19B: proximal side of distal handle 938; par. 0075: “the translational location of the inner cannula 34 in relation to the outer cannula 32 can be controlled by the position of the proximal handle 50 in relation to the distal handle 38”), the depth stop being configured to engage the insertion port to thereby restrict a depth of insertion of the shaft into the guiding sheath based on a position of the depth stop relative to the handle body and shaft (Figs. 19A-19B: adjustable puncture spacer 988 engaging proximal side of distal handle 938 and thereby restricting a depth of insertion of the inner cannula into the outer cannula 932). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use these depth limiting features taught by Kimmel in the device of the combined reference, for the same reasons described previously in the rejections of claims 15 and 19, namely, in order to decrease risk of inadvertent exposure of the tip and thereby decrease risk of injury to the patient, as taught by Kimmel (par. 0090).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Howard in view of Kimmel and Richard and further in view of Chaney et al. (US PGPub No. 2014/0276850), hereinafter Chaney.
Howard in view of Kimmel and Richard teaches the device of claim 19 as described previously. Kimmel further teaches the depth stop and the handle body together defining an effective length of the body assembly (Figs. 19B, 19D: puncture distance 992 and proximal handle 950; par. 0082: “the distance 992 determines a length of a puncture performed by the transseptal needle assembly 930 when the proximal handle 950 is slid forward with respect to the distal handle 938;” examiner interprets the proximal handle length minus the puncture distance as an effective length, as broadly as claimed), the depth stop being longitudinally movable relative to the handle body to thereby vary the effective length of the body assembly (Figs. 19B-19D and par. 0082: “the physician or other user can set a desired puncture length by unlocking the adjustable puncture spacer 988 using the locking button 990, sliding the adjustable puncture spacer 988 to a desired distance 992, and locking the adjustable puncture spacer 988 using locking button 990”).
The combination does not explicitly teach the depth stop extending distally relative to the handle body. However, in an analogous art, Chaney teaches a depth stop for a surgical instrument extending distally relative to a handle body (Fig. 10: depth stop 16 and mounting brackets 76 extending distally relative to handle body 14). Before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person of ordinary skill in the art to configure the depth stop extending distally relative to the handle body, as shown in Chaney, because applicant has not disclosed that the specific distal extension of the depth stop provides an advantage, is used for a particular purpose, or solves a stated problem. Furthermore, one of ordinary skill in the art would have expected the device of the combined reference and applicant’s invention to perform equally well with either the puncture spacer taught by Kimmel or the claimed distally extending depth stop because both depth stops would perform the same function of limiting the effective puncturing length of the surgical instrument. Therefore, it would have been prima facie obvious to modify the combined reference to obtain the invention as specified in claim 21 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Howard in view of Kimmel and Chaney.
Response to Arguments
Applicant’s arguments, filed 15 October 2025, with respect to the rejection(s) of claim(s) 1, 18, and 19 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, in light of the amendments to the claims, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Messing, Roman, and Richard, respectively. As previously described, Messing teaches a constant distal tip diameter, Roman teaches a hollow interior region that is impermeable to fluid distally beyond an opening, and Richard teaches a distal-most flange for a depth-stop that is connected directly to a detent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794