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 .
Response to Amendment
The amendment filed 21 May 2026 has been entered. Claims 1, 18, and 19 are currently amended. Claims 1-8 and 10-21 are pending in the application.
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 19-21 are 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 19 recites the limitation "the detent" in line 22. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, this limitation will be read as the plurality of detents recited earlier in the claim. Dependent claims 20-21 are necessarily rejected as depending upon a rejected base claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
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 outer diameter that is smaller than the lumen diameter at the plane to thereby define a gap at the plane, the distal tip portion having the distal tip outer diameter extending proximally relative to the distal end of the shaft and the plane, the distal tip portion having the distal tip outer diameter extending distally beyond the distal end of the shaft and the plane, the distal tip portion having the distal tip outer diameter further extending distally beyond the distal end of the shaft and the plane, such that the distal tip outer 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 outer diameter that is smaller than the lumen diameter at the plane to thereby define a gap at the plane, the distal tip portion having the distal tip outer diameter extending distally beyond the distal end of the shaft and the plane such that the distal tip outer 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 further teaches wherein the distal tip outer diameter extends proximally relative to the distal end of the shaft and the plane (Figs. 4A-4B: distal tips 435, 480 extending proximally relative to distal ends of shafts 410, 470).
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 Messing and further 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 wherein the distal-most tip defines an outer shaft diameter but does not explicitly teach wherein the dome-shaped distal tip defines an outer dome diameter that is smaller than the outer shaft diameter, or further comprising a tubular body having a body diameter extending from the dome-shaped distal tip to the distal end of the shaft, the body diameter being equal to the outer dome diameter such that a diameter of the tip member is constant from a proximal portion of the dome-shaped distal tip to the distal end of the shaft.
However, Messing teaches an RF catheter with a dome-shaped distal tip defining an outer dome diameter that is smaller than the outer shaft diameter (Fig. 4B: dome-shaped distal tip of distal section 480 smaller in diameter than shaft 470), and further comprising a tubular body having a body diameter extending from the dome-shaped distal tip to the distal end of the shaft, the body diameter being equal to the outer dome diameter such that a diameter of the tip member is constant from a proximal portion of the dome-shaped distal tip to the distal end of the shaft (straight distal section 480 as shown in Fig. 4B), 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."”).
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 dome-shaped distal tip with a tubular body and a diameter smaller than the outer shaft diameter 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 tubular body diameter constant between the distal end of the shaft and the dome-shaped tip, 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.
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 wherein at least one opening is positioned on the tubular body (that 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 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Howard in view of Kimmel and further in view of Santangelo et al. (US PGPub No. 2018/0116654), hereinafter Santangelo.
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, and the depth stop includes the distal-most flange and an elongate member having a plurality of detents, the elongate member, the plurality of detents, and the distal-most flange being monolithic with one another, and wherein the shaft is configured to translate through the elongate member.
However, in an analogous art, Santangelo teaches a tissue treatment apparatus with a depth stop for limiting insertion depth of an insertable element, the depth stop comprising a distal-most flange and an elongate member having a plurality of detents, wherein the insertable element (that is, a shaft) is configured to translate through the elongate member (see annotated Fig. 1: needle 104, depth stop 108; par. 0029: “The handle 102 includes a body with a longitudinal axis 106 and may include an adjustable depth stop 108 for limiting the depth that the needle 104 may be inserted into a tissue site. The axial position of the depth stop 108 may be adjustably fixed with respect to the handle 102, such that the extent of axial motion of translatable elements responsible for deploying implants from the needle 104 is limited by the depth stop 108”).
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Annotated Figure 1
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 and an elongate member having a plurality of detents as shown in Santangelo) 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, the elongate member, and the plurality of detents 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).
Regarding claim 21, the combination teaches the device of claim 19 as described previously. Santangelo further teaches the depth stop extending distally relative to the handle body (Fig. 1: depth stop 108 extending distally relative to handle 102), the depth stop and the handle body together defining an effective length of the body assembly, the depth stop being longitudinally movable relative to the handle body to thereby vary the effective length of the body assembly (par. 0029: “The axial position of the depth stop 108 may be adjustably fixed with respect to the handle 102”).
Response to Arguments
Applicant’s arguments, filed 21 May 2026, with respect to the rejection of claim 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 Santangelo. As described previously, Santangelo teaches a depth stop including a distal-most flange and an elongate member having a plurality of detents, wherein the insertable element is configured to translate through the elongate member.
Applicant’s arguments with respect to the rejection of claim 1 have been fully considered but they are not persuasive. Although the examiner previously indicated in the interview of 21 May 2026 that the proposed amendments appear to overcome the current rejection, with the understanding that the amendments to claim 1 are intended to correspond to the embodiment of the invention shown in Fig. 11 of the applicant’s specification, examiner notes upon further consideration that the claims do not explicitly recite wherein the portion of the distal tip that extends proximal to the distal end of the shaft has a constant outer diameter with the rest of the distal tip, as shown in Fig. 11. Rather, a constant outer diameter is only recited for the portion of the distal tip extending distal to the distal end of the shaft, which is shown in Messing’s Fig. 4B. Messing also teaches in the same figure that the distal tip outer diameter (broadly recited in claim 1 such that a decreased diameter is not excluded from interpretation) extends proximally relative to the distal end of the shaft.
Examiner further notes that although Messing does not explicitly teach that the proximally-extending portion of the distal tip is constant in outer diameter, in light of Messing’s alternative embodiments in Figs. 4A-4B (see constant proximal diameter in Fig. 4A, in particular), it would have been an obvious matter of design choice to a person of ordinary skill in the art to make the proximal diameter constant, since Applicant has not disclosed that the shape or angle of the proximal diameter provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art would have expected either of the distal tips disclosed in Messing’s Figs. 4A-4B and Applicant’s invention to perform equally well with either the proximal diameter shapes taught by Messing or the proximal diameter of the claimed invention, because both would perform the same general function of providing an irrigation flow path directed over the distal tip for cooling.
Applicant’s arguments with respect to the rejection of claim 18 under 35 U.S.C. 103 are persuasive in that the amendments to the claim distinguish over the previous rejection in view of Howard and Roman. However, a new ground of rejection is made in view of Howard and Roman and further in view of Messing, for the same reasons articulated previously in the arguments with respect the application of Messing’s teachings to claim 1.
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 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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/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights