DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/23/2026 and 12/30/2024 have been considered by the examiner.
Status of the Claims
The claims filed 12/11/2024 are under consideration.
Claims 12-26 are pending.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claim(s) 12-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-9 of US Pat. No. 11744729 and Lee-Sepsick, 20090277455.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Applicable to claim 12: The claims of the reference patent teach a method for occluding at least one fallopian tube in a human or animal body comprising a) providing to the uterus of a human or animal a controlled delivery device capable of delivering an effective amount of a composition comprising an occlusive material, wherein the delivery device comprises at least an insertion tube for providing at least one catheter; at least one catheter comprising an end structure on a delivery end that maintains the delivery end in at least one uterine cornua and aids in localized delivery of the composition; a handle comprising a level, a receptacle for receiving a material cartridge and a slider for moving a catheter slide, wherein the catheter slide moves the at least one catheter in a proximal or distal direction; a system plunger controlled by a lock, wherein the lock is movable between position one and position two; wherein the system plunger is reversibly coupled to a control rod, the control rod defining two sets of parallel connecting elements, one set comprising attachment elements for moving two air syringes, and a second set comprising positioning elements, for moving material plunger actuators; wherein the lock is movable between a first position and a second position, and, when the lock is in the first position, the system plunger and the control rod are coupled such that movement of the system plunger moves the control rod, and when the lock is in the second position, the system plunger and the control rod are uncoupled such that the system plunger can move independently of the control rod and a material cartridge containing the composition comprising an occlusive material positioned within the receptacle in the handle; b) delivering an effective amount of the composition comprising an occlusive material through and out the at least one catheter at or near the uterine cornua such that the occlusive material occludes the lumen of the fallopian comprising the following steps: i) with the system plunger rigidly coupled with the control rod and the lock in the lock position one, inserting the material cartridge containing the occlusive material within the receptacle in the handle; ii) moving the slider from a proximal position to a distal position so that the catheter slide moves the at least one catheter so that the at least one catheter delivery end exits the insertion tube and is positioned in the uterine cornua; iii) distally moving the rigidly coupled system plunger and control rod so that air is moved to fill the end structure of at least one catheter; iv) moving the lock to the lock position two which uncouples the system plunger from the control rod so that when system plunger moves, the control rod is stationary; v) moving the system plunger further distally, while the control rod remains stationary, so that the occlusive material is moved from the material cartridge through and out the delivery end of at least one catheter and into at least the uterine cornua; vi) returning the lock to the lock position one to rigidly reengage the system plunger and the control rod; vii) moving the rigidly engaged system plunger and control rod in a proximal direction which deflates the end structure of at least one catheter; and viii) withdrawing the insertion tube from the human or animal body. See claim 1.
The difference between the presently claimed invention and that of the reference claims is that the reference claims teach a device having at least one catheter whereas the presently claimed invention requires two catheters.
Lee-Sepsick teaches devices like those claimed by the reference patent wherein the device is used in a method for delivering an occlusive composition to two fallopian tubes through two catheters (Lee-Sepsick, e.g., 0041-0043, 0107, 0111-0113, and claims 1-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify the device in the method claimed by the reference patent by configuring the device with two catheters with a reasonable expectation of success. The instantly claimed number of catheters (two) is within the range of at least one catheter claimed by the reference patent. Moreover, Lee-Sepsick provides a teaching which would have prompted the skilled artisan to practice the method claimed by the reference patent on two fallopian tubes using a device with two catheters with a reasonable expectation of success. The skilled artisan would have had a reasonable expectation of success because Lee-Sepsick suggests such methods may be practiced by delivery to two fallopian tubes using two catheters without repositioning of the entire device using two catheters.
Limitations of dependent claims 13-26 are found in the dependent claims of the reference patent.
Accordingly, the subject matter of claims 12-26 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim(s) 12-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of US 12127968 and Lee-Sepsick, 20090277455.
The claims of the reference application teach a contraceptive device, comprising at least an insertion tube for providing at least one catheter; at least one catheter, comprising an end structure on a delivery end that maintains the delivery end in at least one uterine cornua and aids in localized delivery of the one or more compositions; a handle comprising a level, a receptacle for receiving a material cartridge and a slider for moving a catheter slide, wherein the catheter slide moves the at least one catheter in a proximal or distal direction; a system plunger controlled by a lock, wherein the lock is movable between position one and position 2; wherein the system plunger is reversibly coupled to a control rod, the control rod defining two sets of parallel connecting elements, one set comprising attachment elements for moving two air syringes, and a second set comprising positioning elements, for moving material plunger actuators; wherein the lock is movable between a first position and a second position, and, when the lock is in the first position, the system plunger and the control rod are coupled such that movement of the system plunger moves the control rod, and when the lock is in the second position, the system plunger and the control rod are uncoupled such that the system plunger can move independently of the control rod and optionally, the optional material cartridge, optionally positioned within the receptacle in the handle, and the optional material cartridge optionally containing a composition comprising an occlusive material.
Although the reference claims a device comprising at least one catheter, the reference claims do not expressly teach the device comprising two catheters.
Lee-Sepsick teaches methods of using devices like those of the reference patent claims for occluding fallopian tubes to achieve contraception. Methods comprise the use of two catheters (Lee-Sepsick, e.g., 0041-0043, 0107, 0111-0113, and claims 1-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify a device of the reference claims by configuring the device with two catheters as suggested by Lee-Sepsick with a reasonable expectation of success. The instantly claimed number of catheters (two) is within the range of at least one catheter claimed by the reference patent. Moreover, Lee-Sepsick provides a teaching which would have prompted the skilled artisan to modify the reference device with two catheters with a reasonable expectation of success. The skilled artisan would have had a reasonable expectation of success because Lee-Sepsick suggests such methods may be practiced by delivery to two fallopian tubes using two catheters without repositioning of the entire device using two catheters.
Limitations of dependent claims 13-26 are found in the reference dependent claims.
Accordingly, the subject matter of claims 12-26 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claim(s) 12-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of US 122582546.
The reference claims are directed to a method for occluding two fallopian tubes in communication with a uterus of a human or animal body, comprising,
a) providing to the uterus of a human or animal having two uterine cornuas a controlled delivery device capable of delivering an effective amount of a composition comprising an occlusive material, wherein the delivery device comprises at least an insertion tube for providing two catheters; two catheters, each catheter comprising an end structure on a delivery end that maintains the delivery end near the uterine cornuas and aids in localized delivery of the composition, a handle comprising a level, a receptacle for receiving a material cartridge and a slider for moving a catheter slide, wherein the catheter slide moves the two catheters in a proximal or distal direction; a system plunger controlled by a lock, wherein the lock is movable between position one and position two; wherein the system plunger is reversibly coupled to a control rod, the control rod defining two sets of parallel connecting elements, one set comprising attachment elements for moving two air syringes, and a second set comprising positioning elements, for moving material plunger actuators; wherein the lock is movable between a first position and a second position, and, when the lock is in the first position, the system plunger and the control rod are coupled such that movement of the system plunger moves the control rod, and when the lock is in the second position, the system plunger and the control rod are uncoupled such that the system plunger can move independently of the control rod and a material cartridge containing the composition comprising an occlusive material positioned within the receptacle in the handle;
The presently claimed invention recites an insertion tube for providing at least one catheter which reads on the insertion tube of the reference device for providing two catheters.
The reference claims anticipate the presently claimed device.
Limitations of dependent claims 13-26 are found in the reference dependent claims.
The skilled artisan would consider the presently claimed device to be an obvious variant of the device in the reference claims.
Claim(s) 12-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of US 19544550 and Lee-Sepsick, 20090277455.
The reference claims, e.g., claim 1, b), teach a controlled delivery device capable of delivering an effective amount of a composition comprising an occlusive material, wherein the delivery device comprises at least an insertion tube for providing at least one catheter; at least one catheter comprising an end structure on a delivery end that maintains the delivery end in at least one uterine cornua and aids in localized delivery of the composition; a handle comprising a level, a receptacle for receiving a material cartridge and a slider for moving a catheter slide, wherein the catheter slide moves the at least one catheter in a proximal or distal direction; a system plunger controlled by a lock, wherein the lock is movable between position one and position two; wherein the system plunger is reversibly coupled to a control rod, the control rod defining two sets of parallel connecting elements, one set comprising attachment elements for moving two air syringes, and a second set comprising positioning elements, for moving material plunger actuators; wherein the lock is movable between a first position and a second position, and, when the lock is in the first position, the system plunger and the control rod are coupled such that movement of the system plunger moves the control rod, and when the lock is in the second position, the system plunger and the control rod are uncoupled such that the system plunger can move independently of the control rod and a material cartridge containing the composition comprising an occlusive material positioned within the receptacle in the handle.
Although the reference claims a device comprising at least one catheter, the reference claims do not expressly teach the device comprising two catheters.
Lee-Sepsick teaches methods of using devices like those of the reference patent claims for occluding fallopian tubes to achieve contraception. Methods comprise the use of two catheters (Lee-Sepsick, e.g., 0041-0043, 0107, 0111-0113, and claims 1-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify a device of the reference claims by configuring the device with two catheters as suggested by Lee-Sepsick with a reasonable expectation of success. The instantly claimed number of catheters (two) is within the range of at least one catheter claimed by the reference patent. Also, Lee-Sepsick provides a teaching which would have prompted the skilled artisan to practice the reference method on two fallopian tubes using a device with two catheters with a reasonable expectation of success. The skilled artisan would have had a reasonable expectation of success because Lee-Sepsick suggests such methods may be practiced by delivery to two fallopian tubes using two catheters without repositioning of the entire device using two catheters.
Limitations of dependent claims 13-26 are found in the reference dependent claims.
Accordingly, the subject matter of claims 12-26 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
