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Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Non-Statutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 25-36, and 40-42 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, and 8 of U.S. Patent No. 9,579,448. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 25, patent claim 1 discloses an apparatus comprising: (a) a body (e.g., handle of patent) having a distal end (Col. 17, line 2); (b) a guide shaft (sinus guide catheter; a guide catheter is a specific type of guide shaft element) extending distally from the distal end of the body (Col. 17, line 5); (c) a movable guiding element (guiding element, Col. 17, line 6; Col. 17, lines 12-14 disclose the guiding element as slidable or movable) for accessing a passageway in a head of a patient (Col. 17, line 6 discloses accessing the sinus which is a passageway in the head), the movable guiding element being slidable relative to the guide shaft (Col. 17, lines 12-13); (d) a dilation catheter (Col. 17, line7 discloses a balloon dilation catheter which is a specific type of dilation catheter) for dilating a passageway in a head of the patient (the sinus), the dilation catheter being slidable relative to the guide shaft (Col. 17, lines 12-13 disclose each element as slidable); (e) a dilation catheter slider (the dilation catheter movement mechanism is claimed as slidable in the patent) slidable along the body (Col. 17, line 7 and line 21 which discloses the sliding relationship); and (f) a guiding element actuator (guiding element movement actuator) slidable along the body (Col. 17, line 12); wherein the dilation catheter slider and the guiding element actuator are slidable along the body for single handed movement of the movable guiding element and dilation catheter to access and dilate the passageway in the head of the patient while the guide shaft is disposed in the head of the patient (the guiding element is for accessing the sinus; Col. 17, lines 12-15); wherein the guiding element actuator and the dilation catheter slider are configured to be longitudinally co-located with each other (Col. 17, lines 18-19 disclose that they are longitudinally aligned which is considered to be co-located); wherein the dilation catheter slider is located on top of the guiding element actuator and is configured to slide over the guiding element actuator (claim 1 discloses that the guiding element movement mechanism and balloon catheter movement mechanism are longitudinally co-located as balloon catheter moves over the top of the guiding element movement mechanism which implies that at some point during movement of one element relative to the other, that they are co-located; Col. 17, lines 18-22).
Regarding claim 26, the subject matter is known from claim 1 of the patent which discloses the balloon inflation lumen.
Regarding claim 27, the subject matter is known from claim 1 of the patent which discloses the guiding element lumen.
Regarding claim 28, the subject matter is known from claim 1 of the patent (the handle of claim 1 of the patent has a “handle” between the proximal and distal ends of the handle body disclosed).
Regarding claims 29-31, the subject matter is known from claim 2 of the patent which discloses single finger use of the sliders (the dilation catheter will move relative to the body or the guide shaft as its manipulated; claim 1 sets forth single-handed use of the sliders via the handle and claim 2 discloses the use of a single finger or thumb).
Regarding claim 32, the subject matter is known from claim 4 of the patent.
Regarding claim 33, the subject matter is known from claim 8 of the patent which discloses the sinus illumination system.
Regarding claim 34, the subject matter is known from claim 1 of the patent wherein the balloon catheter guiding element movement mechanism is on top of the guiding element movement mechanism and slides over it. Therefore, they are movable relative to one another as claimed.
Regarding claim 35, the subject matter is known from claim 1 of the patent wherein the balloon catheter guiding element movement mechanism is on top of the guiding element movement mechanism and slides over it. Therefore, they are movable relative to one along at least a similar longitudinal rage as one another as claimed. The claim does not require the movement portions to move the exact same axial or longitudinal distance, but only that they overlap.
Regarding claim 36, patent claim 1 discloses, An apparatus comprising: (a) a guide shaft (sinus guide catheter is a specific type of guide shaft); (b) a guiding element (Col. 17, line 6); (c) a guiding element actuator (Col. 17, line 12; “guiding element movement mechanism” is a type of actuator), the guiding element actuator being operable to drive longitudinal movement of the guiding element relative to the guide shaft (Col. 17, lines 12-22; the elements are “slidable along the handle” which describes longitudinal movement); (d) a dilation catheter (balloon dilation catheter) comprising: (i) a proximal end, (ii) a distal end, and (iii) a shaft extending between the proximal end and the distal end (a catheter has all of the claimed ends and a shaft extending therebetween); and (e) a dilation catheter actuator (balloon catheter movement mechanism is an actuator) located on top of the guiding element actuator and configured to slide over the guiding element actuator (Col. 17, lines 12-22 disclose this relationship), the dilation catheter actuator being secured to the shaft of the dilation catheter (in order to allow slidable movement the actuator must be secured to the shaft so as to manipulate it via the slidability along the handle), the dilation catheter actuator being operable to drive longitudinal movement of the dilation catheter relative to the guide shaft (the actuator is used to move the balloon dilation catheter relative to the guiding element shaft which is considered to meet the claim limitations; the two movement elements are disclosed as sliding along the handle or body of the device).
Regarding claim 40, the subject matter is known from claim 1 of the patent (Col. 17, lines 12-22).
Regarding claim 41, the subject matter is known from claim 1 of the patent wherein the balloon catheter guiding element movement mechanism is on top of the guiding element movement mechanism and slides over it. Therefore, they are movable relative to one another as claimed.
Regarding claim 42, the subject matter is known from claim 1 of the patent wherein the balloon catheter guiding element movement mechanism is on top of the guiding element movement mechanism and slides over it. Therefore, they are movable relative to one along at least a similar longitudinal rage as one another as claimed. The claim does not require the movement portions to move the exact same axial or longitudinal distance, but only that they overlap.
Claims 37-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,579,448 in view of Goldfarb et al. (US 2012/0071856).
Regarding claim 37, patent claim 1 discloses the dilation catheter actuator, and further discloses the proximal and distal shaft sections in claim 6. However, the patent fails to explicitly place the dilation catheter actuator on the proximal shaft section.
Goldfarb et al. (henceforth Goldfarb) teaches a catheter system comprising a balloon dilation catheter (108; Figure 4) having a proximal shaft section (engaged with slider 114) and a distal shaft section (comprising balloon 110), wherein the dilation catheter actuator is secured to the proximal shaft section (Figure 4, the actuator 114 is secured to a portion of the balloon catheter within handle 102 which would be at the proximal end of the balloon catheter as depicted).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the patent device to place the dilation catheter actuator on a proximal segment of the dilation catheter so as to allow the dilation catheter to be guided to the target site via the handle assembly as taught by Goldfarb.
Regarding claim 38, the patent fails to explicitly disclose the balloon on the distal shaft section of the dilation catheter. However, Goldfarb teaches (Figure 4) that the balloon (110) is located on the distal shaft of the balloon dilation catheter (Figure 4).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the distal shaft of the patent balloon catheter device to comprise the balloon so as to allow for the balloon to be delivered to the target site for dilation while using the handle at the proximal end as taught by Goldfarb.
Regarding claim 39, the patent fails to explicitly disclose the guiding element including a guidewire. However, Goldfarb teaches (Figure 4) wherein a catheter system comprises a guiding element as a guidewire (106).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the patent guiding element to be a guidewire, as taught by Goldfarb, so as to allow a user to guide the balloon dilation catheter to a target location in a patient’s vasculature during a procedure as taught by Goldfarb (¶¶ [0078]-[0079]).
Claims 43 and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,579,448 in view of Johnson et al. (US 5,460,185).
Regarding claim 43, patent claim 1 discloses an apparatus comprising: (a) a guide member (sinus guide catheter); (ii) a guide member actuator (guiding element actuator; Col. 17, lines 12-14), the guidewire actuator being operable to drive translation of the guidewire relative to the guide member (Col. 17, lines 12-14); and (c) a dilation catheter assembly (balloon dilation catheter), comprising: (i) a catheter shaft having a proximal portion and a distal portion (shaft of the catheter), (ii) an expandable dilator positioned at the distal portion of the catheter shaft (balloon), and (iii) a dilation catheter actuator positioned at the proximal portion of the catheter shaft (Col. 17, lines 12-22), the dilation catheter actuator being operable to drive translation of the dilation catheter shaft relative to the guide member (Col. 17, lines 12-22); the dilation catheter actuator is configured to be located on top of the guidewire actuator and to slide over the guidewire actuator (Col. 17, lines 17-22 disclose the sliding relationship). The patent fails to disclose the guiding element as a guidewire and the U-shaped cavity.
Johnson et al. (henceforth Johnson) teaches (Figure 1) an apparatus comprising a guide member embodied as a guidewire (24) which is manipulated via a handle (33) comprising a U-shaped slot for receiving another element and sliding over the top of said element (the handle slides along the balloon catheter (Col. 6, line 62-Col. 7, line 8). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the patent device to utilize a guidewire as the guiding element as such a guide element is well-known in the art for locating balloon dilation catheters at a target site during a procedure as taught by Johnson (see e.g., Col. 7, line 55-Col. 8, line 39 which disclose the use of the device and describe the guidewire as located within the patient’s vasculature).
As above, the patent also fails to teach the U-shaped cavity. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the dilation catheter guiding element to comprise a U-shaped cavity for moving over the top of the guidewire actuator so as to provide a means of maintaining alignment of the two elements during deployment as taught by Johnson (e.g., Col. 6, line 62-Col. 7, line 8). In such a configuration, the patent already discloses that the dilation catheter actuator slides over-the-top of the guidewire actuator and in such a combination, the dilation catheter would be modified to comprise the cavity of Johnson to receive the guidewire actuator and allow the two elements to move relative to one another while maintaining a desired orientation between the two actuators during use as taught above by Johnson.
Regarding claim 44, the subject matter is known from claim 1 of the patent (Col. 17, lines 1-22; both actuators are slidable along the handle).
Claims 25-36 and 40-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-17 of U.S. Patent No. 11,844,539. Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 25, the patent discloses an apparatus comprising: (a) a body having a distal end (Col. 17, line 8, a handle is a type of body); (b) a guide shaft (Col. 17, line 10) extending distally from the distal end of the body (Col. 17, line 10, attached to the distal end of the handle would be extending therefrom); (c) a movable guiding element (Col. 17, lines 11-13; the guiding element is slidable and therefore movable) for accessing a passageway in a head of a patient, the movable guiding element being slidable relative to the guide shaft (Col. 17, lines 11-13); (d) a dilation catheter for dilating a passageway in a head of the patient, the dilation catheter being slidable relative to the guide shaft (Col. 17, lines 14-18); (e) a dilation catheter slider (Col. 17, lines 17-18; the actuator is slidable and is therefore a “slider” as claimed) slidable along the body (Col. 17, lines 14-30); and (f) a guiding element actuator slidable along the body (Col. 17, line 19, it’s slidable along the handle); wherein the dilation catheter slider and the guiding element actuator are slidable along the body for single handed movement of the movable guiding element and dilation catheter to access and dilate the passageway in the head of the patient while the guide shaft is disposed in the head of the patient (Col. 17, lines 11-22 disclose the relative movement without removing the medical device form the head); wherein the guiding element actuator and the dilation catheter slider are configured to be longitudinally co-located with each other (Col. 17, lines 26-27, longitudinally aligned and on top of one another describes co-located); wherein the dilation catheter slider is located on top of the guiding element actuator and is configured to slide over the guiding element actuator (Col. 17, lines 28-30).
Regarding claim 26, the subject matter is known from claim 2 of the patent which discloses the inflation lumen.
Regarding claim 27, the subject matter is known from claim 3 of the patent which discloses the guiding element lumen in the dilation catheter and which would receiving the guiding element.
Regarding claim 28, the subject matter is known from claim 1 of the patent (the handle of claim 1 of the patent has a “handle” between the proximal and distal ends of the handle body disclosed).
Regarding claim 29, the subject matter is known from claim 5 of the patent.
Regarding claim 30, the subject matter is known from claim 6 of the patent.
Regarding claim 31, the subject matter is known from claim 7 of the patent.
Regarding claim 32, the subject matter is known from claim 8 of the patent.
Regarding claim 33, the subject matter is known from claim 9 of the patent.
Regarding claim 34, the subject matter is known from claim 10 of the patent.
Regarding claim 35, the subject matter is known from claim 11 of the patent (they’re longitudinally aligned as per claim 1 and so movement along the handle will be in the same longitudinal range of motion as claimed).
Regarding claim 36, patent claim 16, discloses: an apparatus comprising: (a) a guide shaft (Col. 18, line 9); (b) a guiding element (Col. 18, line 10); (c) a guiding element actuator (Col. 18, line 11), the guiding element actuator being operable to drive longitudinal movement of the guiding element relative to the guide shaft (claim 16; Col. 18, lines 30-32); (d) a dilation catheter comprising: (i) a proximal end, (ii) a distal end, and (iii) a shaft extending between the proximal end and the distal end (Col. 18, lines 13-15); and (e) a dilation catheter actuator located on top of the guiding element actuator and configured to slide over the guiding element actuator (Col. 18, lines 16-20), the dilation catheter actuator being secured to the shaft of the dilation catheter (it’s located on the shaft system as per (iii) and is therefore secured thereto so as to drive the longitudinal motion of the dilation catheter), the dilation catheter actuator being operable to drive longitudinal movement of the dilation catheter relative to the guide shaft (set forth in claim 16).
Regarding claim 40, the subject matter is known from claim 16 of the patent.
Regarding claim 41, the subject matter is known from claim 17 of the patent.
Regarding claim 42, the subject matter is known from claim 16 of the patent wherein the balloon catheter guiding element movement mechanism is on top of the guiding element movement mechanism and slides over it. Therefore, they are movable relative to one along at least a similar longitudinal rage as one another as claimed. The claim does not require the movement portions to move the exact same axial or longitudinal distance, but only that they overlap.
Claims 37-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,844,539 in view of Goldfarb et al. (US 2012/0071856).
Regarding claim 37, patent claim 1 discloses the dilation catheter actuator, and further discloses the proximal and distal shaft sections in claim 6. However, the patent fails to explicitly place the dilation catheter actuator on the proximal shaft section.
Goldfarb et al. (henceforth Goldfarb) teaches a catheter system comprising a balloon dilation catheter (108; Figure 4) having a proximal shaft section (engaged with slider 114) and a distal shaft section (comprising balloon 110), wherein the dilation catheter actuator is secured to the proximal shaft section (Figure 4, the actuator 114 is secured to a portion of the balloon catheter within handle 102 which would be at the proximal end of the balloon catheter as depicted).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the patent device to place the dilation catheter actuator on a proximal segment of the dilation catheter so as to allow the dilation catheter to be guided to the target site via the handle assembly as taught by Goldfarb.
Regarding claim 38, the patent fails to explicitly disclose the balloon on the distal shaft section of the dilation catheter. However, Goldfarb teaches (Figure 4) that the balloon (110) is located on the distal shaft of the balloon dilation catheter (Figure 4).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the distal shaft of the patent balloon catheter device to comprise the balloon so as to allow for the balloon to be delivered to the target site for dilation while using the handle at the proximal end as taught by Goldfarb.
Regarding claim 39, the patent fails to explicitly disclose the guiding element including a guidewire. However, Goldfarb teaches (Figure 4) wherein a catheter system comprises a guiding element as a guidewire (106).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the patent guiding element to be a guidewire, as taught by Goldfarb, so as to allow a user to guide the balloon dilation catheter to a target location in a patient’s vasculature during a procedure as taught by Goldfarb (¶¶ [0078]-[0079]).
Claims 43 and 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,844,539 in view of Johnson et al. (US 5,460,185). Regarding claim 43, patent claim 1 discloses an apparatus comprising: (a) a guide member (guide shaft); (ii) a guide member actuator (guiding element actuator; Col. 17, line 19), the guide member actuator being operable to drive translation of the guidewire relative to the guide member (Col. 17, lines 19-25); and (c) a dilation catheter assembly (Col. 17, line 14), comprising: (i) a catheter shaft having a proximal portion and a distal portion (shaft of the catheter), and (iii) a dilation catheter actuator positioned at the proximal portion of the catheter shaft (Col. 17, lines 19-20), the dilation catheter actuator being operable to drive translation of the dilation catheter shaft relative to the guide member (Col. 17, lines 14-16); the dilation catheter actuator is configured to be located on top of the guidewire actuator and to slide over the guidewire actuator (Col. 17, lines 26-30 disclose the sliding relationship). The patent fails to disclose the guiding element as a guidewire, the expandable dilator at the distal end of the shaft, and the U-shaped cavity.
Johnson et al. (henceforth Johnson) teaches (Figure 1) an apparatus comprising a guide member embodied as a guidewire (24) which is manipulated via a handle (33) comprising a U-shaped slot for receiving another element and sliding over the top of said element (the handle slides along the balloon catheter (Col. 6, line 62-Col. 7, line 8); and further wherein a dilator catheter (balloon catheter 12) comprises an expandable dilator (balloon 14) on its distal end ( Figure 1). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the patent device to utilize a guidewire as the guiding element as such a guide element is well-known in the art for locating balloon dilation catheters (having the balloon at the distal end) at a target site during a procedure as taught by Johnson (see e.g., Col. 7, line 55-Col. 8, line 39 which disclose the use of the device and describe the guidewire as located within the patient’s vasculature).
As above, the patent also fails to teach the U-shaped cavity. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the dilation catheter guiding element to comprise a U-shaped cavity for moving over the top of the guidewire actuator so as to provide a means of maintaining alignment of the two elements during deployment as taught by Johnson (e.g., Col. 6, line 62-Col. 7, line 8). In such a configuration, the patent already discloses that the dilation catheter actuator slides over-the-top of the guidewire actuator and in such a combination, the dilation catheter would be modified to comprise the cavity of Johnson to receive the guidewire actuator and allow the two elements to move relative to one another while maintaining a desired orientation between the two actuators during use as taught above by Johnson.
Regarding claim 44, the subject matter is known from claim 1 of the patent (Col. 17, lines 17-19 disclose both the guide member and actuator as slidable and Col. 17, lines 9-10 disclose the guide shaft attached to the distal end of the handle).
Claims 25 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of prior U.S. Patent No. 11,167,080.
Regarding claim 25, patent claim 1 discloses an apparatus comprising: (a) a body having a distal end (Col. 17, line 8; a handle is a body and is analogous in scope); (b) a guide shaft (Col. 17, lines 9-10) extending distally from the distal end of the body (Col. 17, lines 9-10); (c) a movable guiding element (Col. 17, lines 11-13; it's slidable) for accessing a passageway in a head of a patient, the movable guiding element being slidable relative to the guide shaft (Col. 17, lines 11-13); (d) a dilation catheter for dilating a passageway in a head of the patient, the dilation catheter being slidable relative to the guide shaft (Col. 17, lines 14-16); (e) a dilation catheter slider (Col. 17, lines 17-18; the actuator is slidable) slidable along the body (Col. 17, lines 17-18); and (f) a guiding element actuator slidable along the body (Col. 17, line 19, it’s slidable along the handle); wherein the dilation catheter slider and the guiding element actuator are slidable along the body for single handed movement of the movable guiding element and dilation catheter to access and dilate the passageway in the head of the patient while the guide shaft is disposed in the head of the patient (Col. 17, lines 19-25 disclose the single-handed slidable movement); wherein the guiding element actuator and the dilation catheter slider are configured to be longitudinally co-located with each other (Col. 17, lines 26-28); wherein the dilation catheter slider is located on top of the guiding element actuator and is configured to slide over the guiding element actuator (Col. 17, lines 29-31).
Conclusion
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783