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 .
Claim Objections
Claims 10-11 are objected to because of the following informalities:
Claim 10, line 1: “one or more marker” should read –one or more markers--; and
Claim 11, line 1: “one or more marker” should read –one or more markers--.
Appropriate correction is required.
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 1-19 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.
The term “approximately 90 degrees” in claims 1 and 17 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, it is unclear how many degrees away from 90 degrees is disclosed by the language “approximately 90 degrees”. Clarity is needed.
Regarding dependent claims 2-16 and 18-19, dependent claims inherit the deficiencies from the claims from which they depend and are similarly rejected over 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 9-12, 15, 17, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kurth et al., US 20180064915, herein referred to as “Kurth”.
Regarding claim 1, Kurth discloses a system for use in a transseptal crossing ([0002]), comprising: an outer cannula having a proximal end (Figure 22: dilator 55 has a proximal end), a tapered distal end (Figure 23: the distal end of dilator 55 is tapered), a preset curve (Figure 24 and [0006]: “a flexible introducer having an interior lumen, a distal curve, and a distal taper; and a cannula having an interior lumen, a distal curve,”), and a proximal portion extending between the proximal end and the preset curve (Figure 24: the straight portion of dilator 55 is the proximal portion), wherein the preset curve is configured to position the tapered distal end at approximately 90 degrees relative to the proximal portion (Figure 24: the word approximately is very broad and thus the language “approximately 90 degrees” is interpreted broadly); an inner member configured to slide within the outer cannula between a first position and a second position (Figure 23: cannula 39 and [0121]), the inner member having a stiffness greater than a stiffness of the outer cannula ([0120]: “The untapered cannula 39 is used inside the introducer sheath 57 to shape the introducer assembly 31, provide it with enhanced steerability, and to provide columnar support for both the introducer assembly 31 and the floppy guidewire 59 allowing it to be pushed through the septum and thereafter assume an atraumatic J-shaped configuration as it is advanced further.”), wherein in the first position the tapered distal end is positioned approximately 90 degrees relative to the proximal portion (Figure 28) and in the second position the tapered distal end is positioned greater than 90 degrees relative to the proximal portion (Figure 29); and a control mechanism (Figure 1: control handle 26) having a first portion connected to the proximal end of the outer cannula and a second portion connected to a proximal end of the inner member, wherein the control mechanism is configured to move the inner member between the first position and the second position ([0082]: “The sheath and/or other components of the delivery system may be steerable by actuators (not shown) on the control handle 26 to aid in delivering the device along the tortuous vascular path leading to the patient's right atrium. ”).
Regarding claim 2, Kurth discloses the system of claim 1, further comprising a piercing member (Figure 30: guidewire 59 and [0126] and Figure 32: dilator 55).
Regarding claim 3, Kurth discloses the system of claim 2, wherein the piercing member includes a distal radiofrequency electrode ([0093]: “In yet another embodiment of the transseptal puncture device, the blunt, dilator is replaced by a radio frequency (RF) apparatus (not shown). ”).
Regarding claim 4, Kurth discloses the system of claim 1, wherein the control mechanism comprises a handle ([0082]: “The sheath and/or other components of the delivery system may be steerable by actuators (not shown) on the control handle 26 to aid in delivering the device along the tortuous vascular path leading to the patient's right atrium. ”).
Regarding claim 9, Kurth discloses the system of claim 1, wherein the outer cannula is formed of one or more polymer and metallic material ([0085]: “The blunt dilator 12 and the inner guidewire 14 are made from various metals such as, for example, nitinol, steel, or titanium, or alloys thereof or polymers such as polyimide, PEBAX, polyethylene, polytetrafluoroethylene (EPTFE), Fluorinated ethylene propylene (FEP), and polyurethane.”).
Regarding claim 10, Kurth discloses the system of claim 1, further comprising one or more marker located on a portion of the outer cannula or the inner member ([0088]: “The intermediate portion 16 may be comprised of a coil, or a series of spaced bands, more specifically this coil or bands may be a radiopaque material such as gold, platinum, tungsten, iridium, palladium, or any other material easily visible with x-ray, ultrasound, MRI, or other imaging technique. ”).
Regarding claim 11, Kurth discloses the system of claim 10, wherein the one or more marker is radiopaque ([0088]: “The intermediate portion 16 may be comprised of a coil, or a series of spaced bands, more specifically this coil or bands may be a radiopaque material such as gold, platinum, tungsten, iridium, palladium, or any other material easily visible with x-ray, ultrasound, MRI, or other imaging technique. ”).
Regarding claim 12, Kurth discloses the system of claim 1, wherein the outer cannula or the inner member includes a reinforcing material ([0088]: “he intermediate portion 16 may be comprised of a coil, or a series of spaced bands, more specifically this coil or bands may be a radiopaque material such as gold, platinum, tungsten, iridium, palladium, or any other material easily visible with x-ray, ultrasound, MRI, or other imaging technique.”, wherein a coil or band is a reinforcing material).
Regarding claim 15, Kurth discloses the system of claim 1, wherein the inner member includes a beveled or polished distal tip (Figure 23: dilator 55 has a beveled distal tip).
Regarding claim 17, Kurth discloses a dilator for use in a transseptal crossing ([0002]), comprising: an outer cannula having a proximal end (Figure 22: dilator 55 has a proximal end), a tapered distal end (Figure 23: the distal end of dilator 55 is tapered), a preset curve (Figure 24 and [0006]: “a flexible introducer having an interior lumen, a distal curve, and a distal taper; and a cannula having an interior lumen, a distal curve,”), and a proximal portion extending between the proximal end and the preset curve (Figure 24: the straight portion of dilator 55 is the proximal portion); an inner member configured to slide within the outer cannula between a first position and a second position (Figure 23: cannula 39 and [0121]), the inner member having a stiffness greater than a stiffness of the outer cannula ([0120]: “The untapered cannula 39 is used inside the introducer sheath 57 to shape the introducer assembly 31, provide it with enhanced steerability, and to provide columnar support for both the introducer assembly 31 and the floppy guidewire 59 allowing it to be pushed through the septum and thereafter assume an atraumatic J-shaped configuration as it is advanced further.”), wherein in the first position the tapered distal end is positioned approximately 90 degrees relative to the proximal portion (Figure 24: the word approximately is very broad and thus the language “approximately 90 degrees” is interpreted broadly and Figure 28) and in the second position the tapered distal end is positioned greater than 90 degrees relative to the proximal portion (Figure 29); and a control mechanism having a first portion connected to the proximal end of the outer cannula and a second portion connected to a proximal end of the inner member, wherein the control mechanism is configured to move the inner member between the first position and the second position ([0082]: “The sheath and/or other components of the delivery system may be steerable by actuators (not shown) on the control handle 26 to aid in delivering the device along the tortuous vascular path leading to the patient's right atrium. ”).
Regarding claim 20, Kurth discloses a method for performing a transseptal procedure ([0002]), comprising: positioning an outer cannula (Figure 26a: dilator 55) having an inner stiffening member ([0120]: “The untapered cannula 39 is used inside the introducer sheath 57 to shape the introducer assembly 31, provide it with enhanced steerability, and to provide columnar support for both the introducer assembly 31 and the floppy guidewire 59 allowing it to be pushed through the septum and thereafter assume an atraumatic J-shaped configuration as it is advanced further.”)into a right atrium of a patient (Figure 27); withdrawing the inner stiffening member from a portion of the outer cannula to change a shape of the outer cannula (Figure 28); placing a distal end of the outer cannula on the transseptal septum (Figure 29); advancing a piercing member though the inner stiffening member and the outer cannula (Figure 30); and puncturing the transseptal septum with the piercing member (Figures 31-33).
Claim Rejections - 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kurth in view of Scheller et al., US 20190343585, herein referred to as “Scheller”.
Regarding claim 5, Kurth discloses the system of claim 1, but does not explicitly disclose a system wherein the control mechanism comprises a slider.
However, Scheller teaches a system wherein the control mechanism comprises a slider (Figures 6A-E: actuation control 120).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Kurth so that the control mechanism comprises a slider as taught by Scheller so that a user can fix the system in a particular curved position (Scheller [0050]).
Regarding claim 6, Kurth in view of Scheller discloses the system of claim 5, and Scheller further discloses a system wherein the slider forms part of a ratcheting system configured to lock the inner member in a desired position within the outer cannula ([0050]: “Illustratively, a surgeon may actuate an actuation control 120 of a plurality of actuation controls 120 into a detent of an actuation control guide 210, e.g., to temporarily fix an actuation control 120 in a position relative to handle proximal end 202. In one or more embodiments, temporarily fixing an actuation control 120 of a plurality of actuation controls 120 in a position relative to handle proximal end 202 may be configured to temporarily fix flexible housing tube 300 in a particular curved position.”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Kurth so that the slider forms part of a ratcheting system configured to lock the inner member in a desired position within the outer cannula as taught by Scheller so that a user can fix the system in a particular curved position (Scheller [0050]).
Regarding claim 7, Kurth in view of Scheller discloses the system of claim 5, and Scheller further discloses a system wherein the slider moves along a track (Figures 6A-E: actuation control guide 210).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Kurth so that the slider moves along a track as taught by Scheller so that a user can fix the system in a particular curved position (Scheller [0050]).
Regarding claim 8, Kurth in view of Scheller discloses the system of claim 7, and Scheller further discloses a system wherein the track has a length that is substantially the same as an arc length of the preset curve (Figure 6A: actuation control 120 is at the proximal end of actuation control guide 210 and flexible housing tube 300 is fully curved and Figure 6E: actuation control 120 is at the distal end of actuation control guide 210 and flexible housing tube 300 is straight).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Kurth so that the track has a length that is substantially the same as an arc length of the preset curve as taught by Scheller so that a user can fix the system in a particular curved position (Scheller [0050]).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kurth.
Regarding claim 13, Kurth discloses the system of claim 1, but does not explicitly disclose a system wherein the outer cannula has a bend rigidity in the range of 0.01 to 4.62 lbf/in2 and a modulus of elasticity in the range of1X107 to 1X109 Pa. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select a material that has a bend rigidity and a modulus of elasticity in these ranges, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 14, Kurth discloses the system of claim 1, but does not explicitly disclose a system wherein the inner member has a bend rigidity in the range of 0.07 to 130.42 lbf/in2 and a modulus of elasticity in the range of 3X109 to 5X1011 Pa. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to select a material that has a bend rigidity and a modulus of elasticity in these ranges, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kurth in view of Urbanski et al. US 20210137584, herein referred to as “Urbanski”.
Regarding claim 16, Kurth discloses the system of claim 1, but does not explicitly disclose a system wherein the inner member includes one or more slot or groove and increases in flexibility from a proximal end to a distal end.
However, Urbanski teaches a system wherein the inner member (Figure 37: internal metal tube 146) includes one or more slot or groove and increases in flexibility from a proximal end to a distal end (Figure 37: slots 210 and [0080]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Kurth so that the inner member includes one or more slot or groove and increases in flexibility from a proximal end to a distal end as taught by Urbanski to define a boundary between a rigid portion and a flexible tip portion (Urbanski [0081]).
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kurth in view of Kurth et al., US 9821145, herein referred to as “Kurth 2”.
Regarding claim 18, Kurth discloses the dilator of claim 17, but does not explicitly disclose a dilator wherein the preset curve has an arc length in the range of 1 to 8 inches.
However, Kurth 2 teaches a dilator wherein the preset curve has an arc length in the range of 1 to 8 inches (Claim 3: 10-100 mm is about 0.4-4 inches).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the dilator disclosed by Kurth so that the preset curve has an arc length in the range of 1 to 8 inches as taught by Kurth 2 to steer the device to the desired anatomy of the heart (Col. 17, lines 42-47).
Regarding claim 19, Kurth discloses the dilator of claim 17, but does not explicitly disclose a dilator wherein the preset curve has an arc length in the range of 1 to 8 inches.
However, Kurth 2 teaches a dilator wherein the preset curve has a radius of curvature in the range of 2 to 5 inches (Claim 3: 25-100 mm is about 1-4 inches).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the dilator disclosed by Kurth so that the preset curve has a radius of curvature in the range of 2 to 5 inches as taught by Kurth 2 to steer the device to the desired anatomy of the heart (Col. 17, lines 42-47).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nora W Rhodes whose telephone number is (571)272-8126. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794