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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
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 10-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12121225 in view of Hibner et al. (US 2012/0203136). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application is the method of using the apparatus of the patent. The apparatus details the functions of the lead screw which are the same as how the lead screw is used in the method. The differences are concerning the other steps of the method which are taught by Hibner in at least Paragraphs [0078]-[0083]. It would have been obvious to one of ordinary skill in the art to have modified the patent with Hibner because Hibner teaches a method that is usable for a wide variety of procedures and biopsies in multiple anatomical locations (Paragraph 0032) thus one would have reasonable expectation of yielding predictable results of obtaining a biopsy sample through the modification of using the method of Hibner.
Instant Application 18/887,395
Conflicting US Patent No. 12121225
10. A method of operating a biopsy device including a needle assembly having an outer cannula and an inner cannula, the method comprising:
inserting a portion of the needle assembly into tissue of a patient;
firing the biopsy device, wherein, when the needle assembly is in a fired configuration, an outer cannula drive member coupled to the outer cannular is locked in a distal fired position and an inner cannula drive member coupled to the inner cannula is in an unlocked position, and wherein the outer cannula drive member is operatively coupled to the inner cannula drive member via a lead screw coupled to a drive shaft and configured to translate axially along the drive shaft; and
initiating a cutting cycle of the inner cannula including:
begin a cutting stroke of the inner cannula by rotating the lead screw via a motor to retract the inner cannula drive member in a proximal direction;
continue the cutting stroke of the inner cannula by reversing rotation direction of the lead screw via the motor to advance the inner cannula drive member in a distal direction; and
once the inner cannular drive member reaches a full distal position, operating the lead screw in a dwell mode, wherein, when the lead screw is in the dwell mode, continued rotation of the lead screw via the motor compresses a dwell spring while rotating the inner cannula without axial movement.
1. A biopsy system driver, comprising:
a support structure;
a motor secured to the support structure and comprising a rotatable motor output shaft;
a spline rotatably coupled to the support structure and operatively connected to the motor output shaft, wherein activation of the motor rotates the spline;
a drive shaft rotatably coupled to the support structure, wherein the drive shaft is operatively coupled to the spline, wherein rotation of the spline rotates the drive shaft;
an elongate lead screw axially-translatably coupled to the drive shaft, wherein rotation of the drive shaft rotates the lead screw about an axis of the lead screw, wherein the lead screw is axially translatable relative to the drive shaft between a proximal position and a distal position; and
a biopsy instrument drive member comprising a biopsy needle engagement element to operatively couple the biopsy instrument drive member to at least a portion of a biopsy needle, wherein the biopsy instrument drive member is movably coupled to the lead screw between a first position and a second position,
wherein when the lead screw is in the distal position and the biopsy instrument drive member is in the first position, rotation of the lead screw in a first lead screw rotational direction causes axial translation of the biopsy instrument drive member towards the second position, and
wherein when the lead screw is in the distal position and the biopsy instrument drive member is in the second position, rotation of the lead screw in the first lead screw rotational direction causes axial translation of the lead screw towards the proximal position.
Claims 10-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10022110 in view of Hibner et al. (US 2012/0203136). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application is the method of using the apparatus of the patent. The apparatus details the functions of the lead screw which are the same as how the lead screw is used in the method. The differences are concerning the other steps of the method which are taught by Hibner in at least Paragraphs [0078]-[0083]. It would have been obvious to one of ordinary skill in the art to have modified the patent with Hibner because Hibner teaches a method that is usable for a wide variety of procedures and biopsies in multiple anatomical locations (Paragraph 0032) thus one would have reasonable expectation of yielding predictable results of obtaining a biopsy sample through the modification of using the method of Hibner.
Instant Application 18/887,395
Conflicting US Patent No. 11045172
10. A method of operating a biopsy device including a needle assembly having an outer cannula and an inner cannula, the method comprising:
inserting a portion of the needle assembly into tissue of a patient;
firing the biopsy device, wherein, when the needle assembly is in a fired configuration, an outer cannula drive member coupled to the outer cannular is locked in a distal fired position and an inner cannula drive member coupled to the inner cannula is in an unlocked position, and wherein the outer cannula drive member is operatively coupled to the inner cannula drive member via a lead screw coupled to a drive shaft and configured to translate axially along the drive shaft; and
initiating a cutting cycle of the inner cannula including:
begin a cutting stroke of the inner cannula by rotating the lead screw via a motor to retract the inner cannula drive member in a proximal direction;
continue the cutting stroke of the inner cannula by reversing rotation direction of the lead screw via the motor to advance the inner cannula drive member in a distal direction; and
once the inner cannular drive member reaches a full distal position, operating the lead screw in a dwell mode, wherein, when the lead screw is in the dwell mode, continued rotation of the lead screw via the motor compresses a dwell spring while rotating the inner cannula without axial movement.
1. A biopsy system driver, comprising:
a motor having a rotatable motor output shaft;
a support structure;
a drive shaft rotatably coupled to the support structure, the drive shaft comprising or otherwise being operatively connected to the motor output shaft such that activation of the motor rotates the drive shaft;
an elongate lead screw coupled to the drive shaft such that rotation of the drive shaft rotates the lead screw about an axis of the lead screw, the lead screw being axially translatable relative to the drive shaft and to the support structure;
a biopsy instrument drive member threadably coupled to the lead screw such that rotation of the lead screw causes axial translation of one of the lead screw and biopsy instrument drive member relative to the other one of the lead screw and biopsy instrument drive member and to the support structure; and
an elongate cam rotatably coupled to the support structure, wherein the cam is configured to be rotated between a locked position and an unlocked position, and wherein the cam is configured to prevent axial translation of the biopsy instrument drive member relative to the lead screw and to the support structure when the cam is in the unlocked position.
Claims 10-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10022110 in view of Hibner et al. (US 2012/0203136). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application is the method of using the apparatus of the patent. The apparatus details the functions of the lead screw which are the same as how the lead screw is used in the method. The differences are concerning the other steps of the method which are taught by Hibner in at least Paragraphs [0078]-[0083]. It would have been obvious to one of ordinary skill in the art to have modified the patent with Hibner because Hibner teaches a method that is usable for a wide variety of procedures and biopsies in multiple anatomical locations (Paragraph 0032) thus one would have reasonable expectation of yielding predictable results of obtaining a biopsy sample through the modification of using the method of Hibner.
Instant Application 18/887,395
Conflicting US Patent No. 10022110
10. A method of operating a biopsy device including a needle assembly having an outer cannula and an inner cannula, the method comprising:
inserting a portion of the needle assembly into tissue of a patient;
firing the biopsy device, wherein, when the needle assembly is in a fired configuration, an outer cannula drive member coupled to the outer cannular is locked in a distal fired position and an inner cannula drive member coupled to the inner cannula is in an unlocked position, and wherein the outer cannula drive member is operatively coupled to the inner cannula drive member via a lead screw coupled to a drive shaft and configured to translate axially along the drive shaft; and
initiating a cutting cycle of the inner cannula including:
begin a cutting stroke of the inner cannula by rotating the lead screw via a motor to retract the inner cannula drive member in a proximal direction;
continue the cutting stroke of the inner cannula by reversing rotation direction of the lead screw via the motor to advance the inner cannula drive member in a distal direction; and
once the inner cannular drive member reaches a full distal position, operating the lead screw in a dwell mode, wherein, when the lead screw is in the dwell mode, continued rotation of the lead screw via the motor compresses a dwell spring while rotating the inner cannula without axial movement.
1. A biopsy system driver, comprising:
a motor having a rotatable output shaft;
a support structure;
a drive shaft rotatably coupled to the support structure, the drive shaft comprising or otherwise being operatively connected to the motor output shaft such that activation of the motor rotates the drive shaft;
an elongate lead screw coupled to the drive shaft such that rotation of the drive shaft rotates the lead screw about an axis of the lead screw, the lead screw being axially translatable relative to the drive shaft and to the support structure;
a biopsy instrument drive member threadably coupled to the lead screw such that rotation of the lead screw causes axial translation of one of the lead screw and biopsy instrument drive member relative to the other one and to the support structure; and
a dwell spring assembly coupled to the lead screw,
the dwell spring assembly including a cylindrical dwell spring holder having a dwell spring seated therein, wherein a reduced diameter distal extension portion of the lead screw extends through an opening in a proximal end wall of the dwell spring holder, and through a lumen of the dwell spring, respectively, and is connected to a thrust bearing plate adjacent a distal end of the dwell spring,
the dwell spring being sized and configured such that, when the dwell spring holder is fixed to the support structure, the dwell spring resists compression between the thrust bearing plate and proximal end wall of the dwell spring holder sufficient to thereby maintain the lead screw in a fixed position relative to the respective dwell spring holder and support structure during activation of the motor, so that the biopsy instrument drive member moves freely relative to the lead screw.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK FERNANDES whose telephone number is (571)272-7706. The examiner can normally be reached Monday-Thursday 9AM-3PM EST.
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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