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 .
Status of Claims
This office action is responsive to the amendment filed on 09/11/2023. As directed by the amendment: claims 1, 2, 6, 7, 11, 13,14, 16, 17, 21, 22, 24, 26, 28, 32-36 and 44 have been amended, and claims 3-5, 8-10, 12, 15, 18-20, 23, 25, 27, 29-31, 37-43, 45 and 46 have been cancelled. Thus, claims 1, 2, 6, 7, 11, 13,14, 16, 17, 21, 22, 24, 26, 28, 32-36 and 44 are presently pending in this application, and currently examined in the Office Action.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the catheter device comprising a handle comprising a rotatable deployment knob and a traveler, wherein the outer sheath is connected to the traveler and the deployment knob is operatively connected to the traveler such that the traveler and thereby the outer sheath are moved along the longitudinal axis; and the handle further comprising an outer sheath hub that is movable with respect to the grip portion of the handle to move the outer sheath with respect to the inner sheath, wherein the outer sheath is connected to the outer sheath hub (claim 36) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 6, 32 and 34-36 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.
Regarding claim 6, which sets forth the parameter of “the handle further comprises a rotatable axial positioning knob, and a rotatable deflection knob”, on lines 6-7; however this parameter is found to be confusing since it is not clear if these knobs are the same as the “rotatable axial positioning knob”, and the “rotatable deflection knob” as first set forth on lines 15-16 of claim 1 from which claim 6 depends, or if they are additional, and separate/distinct knobs from the ones set forth in claim 1. If they are different, then it is further unclear what exactly the structure of these knobs are, and/or how exactly they relate to the final structure of the catheter device, since the originally filed disclosure does not detail two sets of rotatable axial positioning knobs and two sets of rotatable deflection knobs; however, if they are the same, as they seem to be, then the above mentioned parameter on lines 6-7 is redundant and should be deleted in order to avoid confusion and clarify the claim.
Regarding claim 32, which sets forth the limitation of “a deflection sheath extending along the longitudinal axis”, on line 6; it is unclear if this “deflection sheath” is the same sheath/structure as “the deflection sheath” set forth on line 4 of the claim. If it is different, then it is further unclear what exact structure this sheath entails, and/or how exactly it relates to the final structure of the catheter device, since the originally filed disclosure does not detail two deflection sheaths; however, if it is the same, as it seems to be, then the above mentioned limitation on line 6 is redundant and should be deleted in order to avoid confusion and clarify the claim.
Regarding claim 36, which ultimately depends from claim 1 which sets forth the parameter of the handle comprising a rotatable deployment knob and a traveler, wherein the outer sheath is connected to the traveler and the deployment knob is operatively connected to the traveler, and claim 36 further sets forth “the handle comprises an outer sheath hub that is movable with respect to a grip portion of the handle to move the outer sheath with respect to the inner sheath, wherein the outer sheath is connected with a proximal end to the outer sheath hub”, on lines 1-5; however, this parameter is found to be confusing since it is not clear what exactly the structure of the “outer sheath hub” is, and/or if it is the same structure as the traveler. Specifically, the originally filed specification states that the traveler is “also denoted as outer sheath hub”, however, claim 36 presents the outer sheath hub as a completely different and distinct structure, of the catheter device, in addition to the traveler. Therefore, it is not clear how exactly the outer sheath hub is part of, and/or works with the rest of the structure set forth in the claims of the catheter device, specifically in regard to the traveler, or if it is actually the same structure as the traveler. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight; intended use/functional language and/or method of manufacturing is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2113 & 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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, 2, 6, 7, 11, 13, 14, 21, 22, 26, 28, 32-34 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Scheinbaum et al. (WO 2021/021368), hereinafter Scheinbaum.
Regarding claim 1, Scheinbaum discloses a catheter device (10), illustrated in Figures 1-2C, 4-8, 35, 36 and 39, for implanting a medical implant (70), comprising an outer sheath (22) extending along a longitudinal axis of the catheter device and surrounding a lumen of the outer sheath; an inner sheath (18) extending along the longitudinal axis, wherein the inner sheath is arranged in the lumen of the outer sheath (22), and connected to a support element (40) for supporting the medical implant ([0133] & [0137]); a capsule (106), connected to a distal end of the outer sheath, and being configured to cover the medical implant when the medical implant is arranged on the support element ([0145] & [0147]); a handle (14) comprising a grip portion (202), a rotatable deployment knob (210) and a traveler (2504), wherein the outer sheath (22) is connected to the traveler and wherein the deployment knob (210) is operatively connected to the traveler (2504) such that the traveler, and thereby the outer sheath, are moved along the longitudinal axis with respect to the inner sheath, and the handle comprising a rotatable axial positioning knob (214) and a rotatable deflection knob (206/208) illustrated in Figures 35, 36 and 39 ([0293]; [0294]; [0296]; [0297]; [0306] & [0307]), and a deflection sheath (20) for adjusting the angular orientation of the capsule/the medical implant, illustrated in Figures 2B and 6A ([0134] & [0137]); and though it is not specifically taught that the deployment knob is arranged proximally to the axial positioning knob, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step; it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate location/order for the deployment and axial positioning knobs, including having the deployment knob proximal to the axial positioning knob, since doing so amounts to a mere matter of rearranging known parts of the device, which has been held to involve only routine skill in the art (see MPEP 2144.04).
Regarding claim 2, Scheinbaum discloses the catheter device according to claim 1, wherein the rotatable axial positioning knob (214) is situated between the rotatable deployment knob (210) and the rotatable deflection knob (206/206), illustrated in Figure 35.
Regarding claim 6, Scheinbaum discloses the catheter device according to claim 1, wherein the deflection sheath (20) extends along the longitudinal axis, having a lumen, and arranged in the lumen of the outer sheath (22), wherein the inner sheath (18) is arranged in the lumen of the deflection sheath (20), illustrated in Figures 2A, 2B and 6A ([0137]), wherein the deflection sheath (20) is connected to the grip portion (202), the deflection knob (206/208) is operatively connected to a distal end section (135) of the deflection sheath (20) such that the deflection sheath, and thereby the inner and the outer sheaths, are deflected to adjust an angular orientation of the medical implant when the deflection knob is rotated in a first rotation direction ([0160]; [0293] & [0359]), and wherein the handle (14) comprises a handle core (204) which the inner and the outer sheath (18,22) are connected to, and the axial positioning knob (214) is operatively connected to the handle core (204), such that when the axial positioning knob (214) is rotated the inner and the outer sheath are simultaneously moved with the handle core with respect to the grip portion and the deflection sheath along the longitudinal axis, and wherein the deployment knob (210) is operatively connected to the traveler (2504), such that rotation of the deployment knob in a first rotation direction move the traveler, and thereby the outer sheath (22), along the longitudinal axis with respect to the inner sheath for deploying the medical implant ([0295]; [0297]; [0298]; [0306] & [0307]).
Regarding claim 7, Scheinbaum discloses the catheter device according to claim 1, wherein the deflection knob (206/208) is operatively connected to the distal end section of the deflection sheath (20) via an elongated pulling member (138/140) and via an anchor (135) of the handle, wherein the pulling member (138/140) connects the distal end section of the deflection sheath (20) to the anchor (135) that is configured to be moved with respect to the grip portion along the longitudinal axis in a proximal direction when the deflection knob (206/208) is rotated in the first rotation direction, such that the pulling member (138/140) is tensioned and the deflection sheath is deflected, and wherein the anchor is configured to be moved with the respect to the grip portion along the longitudinal axis in a distal direction when the deflection knob is rotated in an opposite second rotation direction, such that the pulling member is loosened and a deflection of the deflection sheath is reduced ([0160]; [0161] & [0293]).
Regarding claim 11, Scheinbaum discloses the catheter device according to claim 1, wherein the axial positioning knob (214) comprises a helical groove formed in an inside of the axial positioning knob (214), and wherein the handle core (204) comprises a protrusion/thread protruding from an outside of the handle core and engaging with the helical groove of the axial positioning knob (214) to operatively connect the axial positioning knob to the handle core such that the handle core, and therewith the inner and outer sheaths are simultaneously moved with respect to the grip portion along the longitudinal axis in the distal direction when the axial positioning knob (214) is rotated in a first rotation direction, and in the proximal direction when the axial positioning knob is rotated in an opposite second rotation direction, illustrated in Figure 39 ([0307] –[0309]).
Regarding claims 13 and 14, Scheinbaum discloses the catheter device according to claim 1, wherein the deployment knob (210) is rotatably supported on the handle core and comprises a helical groove formed in an inside of the deployment knob (210), wherein the traveler (2504) comprises first and second protrusions/threads protruding from an outside of the traveler (2504), wherein the first and second protrusions/threads engage with the helical groove of the deployment knob (210) such that the traveler (2504) and thereby the outer sheath are moved in a proximal direction along the longitudinal axis with respect to the inner sheath, wherein when the deployment knob (210) is rotated in the first rotation direction the capsule (106) is pulled away from the medical implant in the proximal direction to deploy the medical implant, and such that the traveler (2504), and thereby the outer sheath, is moved in a distal direction along the longitudinal axis with respect to the inner sheath when the deployment knob (210) is rotated in an opposite second rotation direction, so that the capsule (106) is moved back over to re-sheath the medical implant, illustrated in Figure 39 ([0306] –[0309]).
Regarding claims 21 and 26, Scheinbaum discloses the catheter device according to claim 1, wherein the deployment knob (210) comprises a helical groove formed in an inside of the deployment knob (210), wherein the traveler (2504) comprises first and second protrusions, wherein the protrusions comprise a bearing/thread, that engage with the helical groove of the deployment knob (210), such that the traveler (2504) and thereby the outer sheath (22) are moved in a proximal direction along the longitudinal axis with respect to the inner sheath when the deployment knob (210) is rotated in a first rotation direction, so that the capsule (106) is pulled away from the medical implant in the proximal direction to deploy the medical implant, wherein the handle (14) is configured to move the at least one first protrusion/thread out of the helical groove via the deployment knob (210), illustrated in Figure 39 ([0306] –[0309]).
that engages the helical groove of the deployment knob.
Regarding claim 28, Scheinbaum discloses the catheter device according to claim 21, wherein the handle (14) comprises a rod (2510) that extends along the longitudinal axis, wherein the traveler (2504) is configured to slide on said rod (2510) when the deflection knob (210) is rotated in the first or opposite second rotation direction, illustrated in Figure 39 ([0306] & [0307]).
Regarding claims 32 and 34, Scheinbaum discloses the catheter device according to claim 1, wherein the inner sheath (18) surrounds a first lumen for receiving a guidewire, and wherein the outer sheath (22) and the capsule (106) together surround a third lumen, wherein the deflection sheath (20) is arranged in the third lumen, and wherein the deflection sheath (20) surrounds a second lumen, wherein the inner sheath (18) extends through the second lumen, a stabilizing sheath (51) extending along the longitudinal axis and surrounding a fourth lumen, wherein the outer sheath (22) extends through the fourth lumen, illustrated in Figures 1-2B ([0130] & [0137]), and wherein the handle (14) further comprises a flushing port in flow connection with the first lumen, the second lumen, the third lumen and the fourth lumen so as to allow flushing of the first, second, third, and fourth lumen with a liquid medium which is split into first, second, third and fourth streams ([0301]); and though it is not specifically disclosed there are two flushing ports, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step; it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate number of flushing ports, including two, i.e. a first flushing port and a second flushing port, since doing so amounts to a mere matter of duplication of the essential working parts of the device, which has been held to involve only routine skill in the art (see MPEP 2144.04).
Regarding claims 33 and 44, Scheinbaum discloses a catheter device (10), illustrated in Figures 1-2C, 4-8, 35, 36 and 39, for implanting a medical implant (70), comprising an inner sheath (18) extending along a longitudinal axis and surrounding a first lumen for receiving a guidewire, a deflection sheath (20) extending along the longitudinal axis and surrounding a second lumen, wherein the inner sheath (18) extends through the second lumen, an outer sheath (22) extending along the longitudinal axis, a capsule (106) connected to a distal end of the outer sheath (22), for covering the medical implant (70), wherein the outer sheath (22) and the capsule (106) together surround a third lumen, wherein the deflection sheath (20) is arranged in the third lumen, a stabilizing sheath (51) extending along the longitudinal axis and surrounding a fourth lumen, wherein the outer sheath (22) extends through the fourth lumen, illustrated in Figures 1-2B ([0130] & [0137]), a handle (14) configured to move the outer sheath (22) with respect to the inner sheath (18) to release the medical implant, the handle (14) comprising a rotatable deployment knob (210), a rotatable axial positioning knob (214), and a rotatable deflection knob (206/208) operatively connected to a distal end section (135) of the deflection sheath (20), so that the deflection sheath (20) and thereby the inner and the outer sheaths are deflected to adjust an angular orientation of the capsule (106) when the deflection knob (206/208) is rotated in a first rotation direction ([0160]; [0293] & [0359]), and wherein the handle (14) comprises a handle core (204) which the inner and the outer sheath (18 & 22) are connected to, and the axial positioning knob (214) is operatively connected to the handle core (204) such that the inner and the outer sheath (18,22) are simultaneously moved with the handle core with respect to the grip portion and the deflection sheath (20) along the longitudinal axis when the axial positioning knob (214) is rotated, and wherein the deployment knob (210) is operatively connected to the outer sheath hub/traveler (2504) such that the outer sheath hub and thereby the outer sheath (22) are moved along the longitudinal axis with respect to the inner sheath for deploying the medical implant when the deployment knob (210) is rotated in a first rotation direction, illustrated in Figures 35, 36 and 36 ([0295]; [0297]; [0298]; [0306] & [0307]); wherein the handle (14) comprises a flushing port in flow fluid connection with the first lumen, the second lumen, the third lumen and the fourth lumen ([0301]); and though it is not specifically disclosed there are two flushing ports, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step; it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate number of flushing ports, including two, i.e. a first flushing port and a second flushing port, since doing so amounts to a mere matter of duplication of the essential working parts of the device, which has been held to involve only routine skill in the art (see MPEP 2144.04).
Allowable Subject Matter
Claims 16, 17 and 24 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 35 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
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/DINAH BARIA/Primary Examiner, Art Unit 3774 03/21/2026