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 .
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,446,056. Although the claims at issue are not identical, they are not patentably distinct from each other because both application and patent claim a transperineal prostate biopsy device with a transrectal probe.
U. S. Application No. 19,345,031
U. S. Patent No. 11,446,056
1. A transperineal biopsy guide configured for use with an access needle and a transrectal imaging probe configured to provide imaging in an imaging plane, the transrectal imaging probe including a proximal end and a distal end opposite the proximal end, the transperineal biopsy guide comprising: a mount comprising a distal surface and being attachable to the transrectal imaging probe between the proximal end and the distal end; a guide member extending from the mount and comprising: a first extension member comprising a first distal edge extending upwardly and distally relative to the distal surface of the mount; and a first guide rail extending from the first extension member and comprising a first guide rail distal end, a first guide rail proximal end opposite the first guide rail distal end, and a first distal member at the first guide rail distal end, the first distal member being distally and vertically offset from the mount; and an access needle support structure engageable with the first guide rail and slidable in a distal-proximal direction relative to the first guide rail, wherein sliding of the access needle support structure in a distal direction is limited by the first distal member, the access needle support structure configured to support the access needle in an alignment relative to the imagine plane of the transrectal imaging probe when the access needle support structure is engaged with the first guide rail.
1. A method of performing a transperineal biopsy procedure on a prostate of a patient using a transrectal ultrasound probe configured to provide imaging, the patient comprising a perineal access site leading to the prostate, the method comprising: imaging the prostate of the patient with the transrectal ultrasound probe, wherein a transperineal biopsy guide is coupled to the transrectal ultrasound probe, the transperineal biopsy guide comprising a mount coupled to the transrectal ultrasound probe, a guide member coupled to the mount and including a rail receiving channel extending a first length between a proximal end and a distal end of the rail receiving channel, and a displacement member including a rail member extending a second length between a proximal end and a distal end of the rail member and a vertically extending member extending from the distal end of the rail member, the vertically extending member including a plurality of needle receiving ports, wherein the rail receiving channel is positioned generally parallel with a longitudinal axis of the transrectal ultrasound probe; sliding the rail member within the rail receiving channel so as to position the vertically extending member of the displacement member adjacent the perineal access site of the patient; inserting an access needle into the perineal access site of the patient, the access needle supported by one of the plurality of needle receiving ports; and inserting a needle through the access needle and into a first location of the prostate of the patient.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,583,310. Although the claims at issue are not identical, they are not patentably distinct from each other because both application and patent claim a transperineal prostate biopsy device with a transrectal probe.
U. S. Application No. 19,345,031
U. S. Patent No. 11,583,310
1. A transperineal biopsy guide configured for use with an access needle and a transrectal imaging probe configured to provide imaging in an imaging plane, the transrectal imaging probe including a proximal end and a distal end opposite the proximal end, the transperineal biopsy guide comprising: a mount comprising a distal surface and being attachable to the transrectal imaging probe between the proximal end and the distal end; a guide member extending from the mount and comprising: a first extension member comprising a first distal edge extending upwardly and distally relative to the distal surface of the mount; and a first guide rail extending from the first extension member and comprising a first guide rail distal end, a first guide rail proximal end opposite the first guide rail distal end, and a first distal member at the first guide rail distal end, the first distal member being distally and vertically offset from the mount; and an access needle support structure engageable with the first guide rail and slidable in a distal-proximal direction relative to the first guide rail, wherein sliding of the access needle support structure in a distal direction is limited by the first distal member, the access needle support structure configured to support the access needle in an alignment relative to the imagine plane of the transrectal imaging probe when the access needle support structure is engaged with the first guide rail.
1. A method of performing a transperineal biopsy procedure on a prostate of a patient using a transrectal ultrasound probe configured to provide imaging in at least a sagittal imaging plane, the patient comprising a perineal access site leading to the prostate, the method comprising: imaging the prostate of the patient with the transrectal ultrasound probe, wherein a transperineal biopsy guide is coupled to the transrectal ultrasound probe, the transperineal biopsy guide comprising a mount including an adjustable fastener coupled to the transrectal ultrasound probe, a guide member coupled to the mount and including a rail receiving channel extending a first length between a proximal end and a distal end, and a displacement member including a rail member extending a second length between a proximal end and a distal end, and a vertically extending member coupled to the distal end of the rail member, the vertically extending member including a plurality of needle receiving ports; sliding the rail member within the rail receiving channel so as to position the vertically extending member of the displacement member adjacent the perineal access site of the patient; inserting an access needle through one of the plurality of needle receiving ports and into the perineal access site of the patient, the access needle positioned within the sagittal imaging plane; and inserting a needle through the access needle and into a first location of the prostate of the patient.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,547,436. Although the claims at issue are not identical, they are not patentably distinct from each other because both application and patent claim a transperineal prostate biopsy device with a transrectal probe.
U. S. Application No. 19,345,031
U. S. Patent No. 11,547,436
1. A transperineal biopsy guide configured for use with an access needle and a transrectal imaging probe configured to provide imaging in an imaging plane, the transrectal imaging probe including a proximal end and a distal end opposite the proximal end, the transperineal biopsy guide comprising: a mount comprising a distal surface and being attachable to the transrectal imaging probe between the proximal end and the distal end; a guide member extending from the mount and comprising: a first extension member comprising a first distal edge extending upwardly and distally relative to the distal surface of the mount; and a first guide rail extending from the first extension member and comprising a first guide rail distal end, a first guide rail proximal end opposite the first guide rail distal end, and a first distal member at the first guide rail distal end, the first distal member being distally and vertically offset from the mount; and an access needle support structure engageable with the first guide rail and slidable in a distal-proximal direction relative to the first guide rail, wherein sliding of the access needle support structure in a distal direction is limited by the first distal member, the access needle support structure configured to support the access needle in an alignment relative to the imagine plane of the transrectal imaging probe when the access needle support structure is engaged with the first guide rail.
1. A method of performing a transperineal biopsy procedure on a prostate of a patient using a transrectal ultrasound probe configured to provide imaging, the patient comprising a perineal access site leading to the prostate, the transrectal ultrasound probe including a shaft and a handle proximal to the shaft, the method comprising: inserting an access needle into the perineal access site of the patient, the access needle including a hub at a proximal end of the access needle and a tubular shaft extending distally from the hub, the tubular shaft including a lumen sized to receive a biopsy needle therethrough; inserting at least a portion of the tubular shaft of the access needle into one of a plurality of needle receiving ports of a displacement member of a transperineal biopsy guide, the transperineal biopsy guide comprising: a mount releasably coupled to the transrectal ultrasound probe; a guide member coupled to the mount; and the displacement member configured to slide relative to the guide member and including a vertically extending member including the plurality of needle receiving ports; coupling the access needle to the one of the plurality of needle receiving ports of the displacement member of the transperineal biopsy guide such that a position and angle of the access needle relative to the displacement member is retained; and inserting the biopsy needle through the access needle and into a first location of the prostate of the patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANJAY CATTUNGAL whose telephone number is (571)272-1306. The examiner can normally be reached M-F 9-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at 571-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SANJAY CATTUNGAL/Primary Examiner, Art Unit 3798
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