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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a translation member” and “a rotation member” in claims 7 and “a reversing mechanism” in claim 20. The corresponding structure identified in the specification is the receiver with at least an internal thread, see ¶44, for the translation member, a geared portion 652, see ¶46 and 47, as the rotation member and the protrusion of the housing 672 as the reversing mechanism.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 8 is 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. The claim recites that rotation member drives the rotation and translation but claim 7 recites a translation member which presumably drives translation so it is unclear if both the rotary member and the translation drive translation or just the rotation member.
Claim 19 is 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. It is unclear what is meant by the first length corresponds to the second length. In what way does it correspond?
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.
Claim(s) 1 and 4-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nock et al. US 2019/0008493 in view of Moore et al. US 2010/0292607.
Regarding claim 1, Nock discloses a biopsy device ([FIG.1][¶38] device 10), the biopsy device comprising:
(a) a body including an outer housing ([FIG.1][¶38-39] probe 100);
(b) a needle extending distally from the body ([FIG.1][¶49] needle 110);
(c) a cutter configured to rotate and translate relative to the needle ([FIG.3][¶50] cutter 130); and
(d) a cutter drive assembly ([FIG.5][¶55] cutter drive 502), the cutter drive assembly including a cutter overmold secured to a portion of the cutter, the cutter overmold including a threaded portion ([FIG.5][¶56] threaded portion 522) and one or more channels ([FIG.5][¶56] longitudinal channel 528), the threaded portion being configured to drive translation of the cutter, the one or more channels being configured to drive rotation of the cutter ([FIG.5][¶56] the threaded portion 522 engages with the translation member 530 to provide translation to the cutter drive 502. The longitudinal channel 528 engages drive gear 540 to provide rotation to the cutter drive 502),
Nock does not specifically disclose the outer housing defining a resilient member extending inwardly from an inner surface of the outer housing, the resilient member being configured to engage the cutter overmold to apply either a proximally oriented force or a distally oriented force to the cutter overmold. Moore teaches a similar biopsy device where the outer housing defining a resilient member extending inwardly from an inner surface of the outer housing, the resilient member being configured to engage the cutter overmold to apply either a proximally oriented force or a distally oriented force to the cutter overmold ([¶68] members 134 extend from the housing 32 and with 132 and 130 provide a resilient member that biases the cutter assembly. Moore also teaches that the resilient member can have configurations other than a spring). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Nock with the teachings of Moore in order to bias the screw assembly 102 to engage the translation member 110 ([¶68]).
Regarding claim 4, Nock discloses the cutter overmold defining a distal zero pitch portion and a proximal zero pitch portion, the threaded portion being disposed between the distal zero pitch portion and the proximal zero pitch portion ([FIG.5][¶56]).
Regarding claim 5, Moore teaches the resilient member being configured to engage the distal zero pitch portion ([FIG.23] the zero pitch portions engage with the resilient members on either side).
Regarding claim 6, Moore teaches the resilient member being a first resilient member, the outer housing further defining a second resilient member, the first resilient member and the second resilient member extending inwardly from the inner surface of the outer housing in opposite directions ([FIG.23][¶68-70] bias member 154 that presses against the inward projection of the housing 150 is a resilient member which provides a proximal bias and bias member 130 presses against the extension of the housing 134 and forms a resilient member that provides a distal bias. They are opposite in that they are formed such that they are on opposite sides of the threaded portion.).
Regarding claim 7, Nock discloses the cutter drive assembly further including a translation member and a rotation member, the translation member being configured to engage the threaded portion of the cutter overmold, the rotation member being configured to engage the one or more channels of the cutter overmold ([FIG.5][¶56] the threaded portion 522 engages with the translation member 530 to provide translation to the cutter drive 502. The longitudinal channel 528 engages drive gear 540 to provide rotation to the cutter drive 502).
Regarding claim 8, Nock discloses the rotation member being further configured to receive a single rotary input to drive simultaneous rotation and translation of the cutter ([¶60] rotation of drive gear 540 via a gear in the holster drive rotation of the cutter which cause rotation and translation).
Regarding claim 9, Nock discloses the translation member including one or more threads being configured to engage the threaded portion of the cutter overmold ([¶57] threads 536 engage the threaded portion of the cutter).
Regarding claim 10, Moore teaches the resilient member being configured to maintain at least partial engagement between the one or more threads of the translation member and threaded portion of the cutter overmold during reversal of a translation direction of the cutter ([¶66,68,70] the resilient members provide a bias to keep the threaded portion engaged with translation member 110).
Regarding claim 11, Moore teaches the resilient member being configured to maintain at least partial engagement between the one or more threads of the translation member and threaded portion of the cutter overmold during reversal of translation of the cutter from a distal direction to a proximal direction and during reversion of translation of the cutter from the proximal direction to the distal direction ([66,68,70] threads 116,118 are kept in contact with the threaded portion during forward and reverse translation).
Regarding claim 12, Moore teaches the resilient member being configured to disengage from the cutter overmold for a predetermined range of cutter translation ([¶68,70] there is a range of movement where neither flange 108 or 106 engages either resilient member).
Regarding claim 13, Moore teaches the cutter overmold being configured to freely rotate relative to the resilient member ([¶57] the cutter 50 rotates within the housing and is not impeded by the resilient member).
Regarding claim 14, Moore teaches the cutter overmold further including a flange, the resilient member being configured to engage the flange ([FIG.20][¶68,70] flange 108 and 106).
Regarding claim 15, Moore teaches the flange being disposed distally of the threaded portion ([FIG.20] both flanges are distal depending on the perspective, which is not specified for the claim).
Regarding claim 16, Nock discloses probe for use with a biopsy device ([FIG.1][¶38] device 10), the probe comprising:
(a) a housing ([FIG.1][¶38-39] probe 100);
(b) a needle extending distally from the housing ([FIG.1][¶49] needle 110);
(c) a cutter configured to rotate and translate relative to the needle ([FIG.3][¶50] cutter 130); and
(d) a cutter drive assembly ([FIG.5][¶55] cutter drive 502), the cutter drive assembly including a sleeve coaxial with the cutter and configured to drive rotation and translation of the cutter, the sleeve including a threaded portion ([FIG.5][¶56] threaded portion 522) and a keyed portion ([FIG.5][¶56] longitudinal channel 528), the threaded portion being configured to drive translation of the cutter, the keyed portion being configured to drive rotation of the cutter ([FIG.5][¶56] the threaded portion 522 engages with the translation member 530 to provide translation to the cutter drive 502. The longitudinal channel 528 engages drive gear 540 to provide rotation to the cutter drive 502).
Nock does not specifically disclose a portion of the housing extending into a hollow interior of the outer housing to engage at least a portion of the sleeve when the sleeve is in a distal position and a proximal position. Moore teaches a similar biopsy device where disclose the outer housing defining a resilient member extending inwardly from an inner surface of the outer housing, the resilient member being configured to engage the cutter overmold to apply either a proximally oriented force or a distally oriented force to the cutter overmold ([FIG.23][¶68-70] bias member 154 that presses against the inward projection of the housing 150 is a resilient member which provides a proximal bias and bias member 130 presses against the extension of the housing 134 and forms a resilient member that provides a distal bias. They are opposite in that they are formed such that they are on opposite sides of the threaded portion. Moore also teaches that the resilient member can have configurations other than a spring). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Nock with the teachings of Moore in order to bias the screw assembly 102 to engage the translation member 110 ([¶68]).
Regarding claim 17, Moore teaches the biasing members but does not disclose the portion of the housing extending into the hollow interior of the outer housing including an elongate strip, the elongate strip being configured to bend in response to movement of the sleeve within the housing.
However, at the time of filing, it would have been an obvious matter of design choice to a person of ordinary skill in the art to use elongated resilient members because Applicant has not disclosed that elongated strip provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Moore and applicant' s invention, to perform equally well with either the biasing members taught by Moore or the claimed elongated strip because both features would perform the same function of biasing the cutter equally well considering the similar configuration and that Moore teaches that the biasing members can be various things other than springs ([¶50])
Therefore, it would have been prima facie obvious to modify Moore to obtain the invention as specified in the claim because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Moore.
Regarding claim 18, Moore teaches the sleeve including a flange and a distal zero pitch portion, the elongate strip being configured to alternatingly engage the flange and the distal zero pitch portion to maintain engagement between the threaded portion and a portion of the cutter drive assembly ([¶68,70] the flanges and the unpitched portions of the cutter engage with the biasing members to maintain contact between the threads and the drive mechanism).
Regarding claim 19, Moore discloses the flange and the distal zero pitch portion being separated by a first length, the threaded portion defining a second length, the first length corresponding to the second length ([FIG.10]).
Regarding claim 20, Nock discloses a probe for use with a biopsy device ([FIG.1][¶38] device 10), the probe comprising:
(a) a housing ([FIG.1][¶38-39] probe 100);
(b) a needle extending distally from the housing ([FIG.1][¶49] needle 110);
(c) a cutter configured to rotate and translate relative to the needle ([FIG.3][¶50] cutter 130);
(d) a cutter drive assembly ([FIG.5][¶55] cutter drive 502), the cutter drive assembly including a sleeve coaxial with a longitudinal axis defined by the cutter and configured to drive rotation and translation of the cutter, the sleeve including a threaded portion ([FIG.5][¶56] threaded portion 522) and a keyed portion ([FIG.5][¶56] longitudinal channel 528), the threaded portion being configured to drive translation of the cutter, the keyed portion being configured to drive rotation of the cutter ([FIG.5][¶56] the threaded portion 522 engages with the translation member 530 to provide translation to the cutter drive 502. The longitudinal channel 528 engages drive gear 540 to provide rotation to the cutter drive 502),; and
Nock does not specifically disclose a reversing mechanism mechanically grounded to a portion of the housing, the reversing mechanism being configured to bias the sleeve in a predetermined direction parallel to the longitudinal axis of the cutter. Moore teaches a similar biopsy device where the outer housing and resilient member form a reversing mechanism ([¶68,70] member 154 and the inward members of 150 form a reversing mechanism that biases the cutter 50 rearward. Moore also teaches that the resilient member can have configurations other than a spring). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Nock with the teachings of Moore in order to bias the screw assembly 102 to engage the translation member 110 ([¶68]).
Claim(s) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nock et al. US 2019/0008493 in view of Moore et al. US 2010/0292607 further in view of Fojtik US 2014/0142594.
Regarding claim 2, Moore teaches the resilient member being configured to apply both the proximally oriented force and the distally oriented force to the cutter overmold ([¶68-70] bias member 154 provides a proximal bias and resilient member 134,130 provides a distal bias. Moore does not teach a resilient member that does both. Fojtik teaches a similar biopsy device ([¶115]) that has a single biasing element that provides a proximal and distal bias ([¶70,71] element 92). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Nock and Moore with the teachings of Fojtik in order to enable smooth movement of the rotatable element.
Regarding claim 3, Fojtik teaches the resilient member being configured to apply the proximally oriented force or the distally oriented force to the cutter overmold depending on the orientation of the cutter overmold relative to the resilient member ([¶70,71] element 92).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 5712723672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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