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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 29, 2025 has been entered. The Examiner acknowledges the amendments to claims 7-8, 12-14, 16, 21-24, 26-27 and 29, and the cancellation of claims 1-6 and 18-20. Claims 7-17 and 21-29 are currently pending.
Response to Arguments
Applicant’s arguments, see remarks, filed August 29, 2025, with respect to rejection of claim 26 under 35 USC 112(a) and with respect to the rejection of claims 26 & 27 under 35 USC 112(b) have been fully considered and are persuasive. The previous rejection of claim 26 under 35 USC 112(a) and the rejection of claims 26 & 27 under 35 USC 112(b) have been withdrawn.
Applicant’s arguments, see remarks, filed August 29, 2025, with respect to the rejection of claims 7-17 & 27-29 under 35 USC 103 over Williams, McKillip, and Hathaway have been fully considered and are persuasive. The Examiner agrees that Williams, McKillip, and Hathaway fail to teach at least one floating flexure strip attached to first and second sidewalls of the body (as recited in claim 7) and at least one floating flexure strip that is attached at a first end to a first side wall of the body and at a second end to a second side wall of the body (as recited in claim 27). Thus, the previous rejections of claims 7-17 & 27-29 under 35 USC 103 over Williams, McKillip, and Hathaway have been withdrawn.
However, with respect to claims 21-26, the Examiner disagrees with Applicant’s arguments that Williams does not teach, suggest, or provide any reason for at least one floating flexure strip coupled to the cannula piston, wherein the floating flexure strip is movable between a first strip position and a second strip position, as claimed, and McKillip does not teach, suggest, or provide any reason for at least one floating flexure strip coupled to the cannula piston, wherein the floating flexure strip is movable between a first strip position and a second strip position, as claimed. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a floating flexure strip that is not in contact with top or bottom walls and is free from frictional engagement with other device components, which provides improvements such as reduced friction, improved energy storage and release, and enhanced reliability in actuation) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Moreover, Williams teaches a body (i.e., an outer portion of the biopsy device) (see outer portion of device in Williams, fig. 1), an outer cannula 24 (see Williams, par 0022, 0025, fig. 1), an actuation mechanism disposed within the body (see Williams, figs. 1, 3A-3B, par 0027, 0031, 0034-0037) comprising: a cannula piston 74 (i.e., a trigger or actuator) moveably disposed within the piston cavity and coupled to the outer cannula such that the outer cannula is axially constrained in relation to the cannula piston (see Williams, figs. 1, 3A-3B, par 0027, 0031, 0034-0037); and at least one spring 78 coupled to the cannula piston, wherein the spring is movable between a first position and a second position (i.e., the spring is movable between a compressed position and a relaxed position) (see Williams, fig. 1, par 0027, 0034, 0037, 0039, 0047), wherein movement of the actuation handle from the intermediate handle position toward the first handle position causes the actuation mechanism to urge the outer cannula distally (see Williams, par 0034, 0039, 0041, 0047). Williams fails to teach at least one floating flexure strip that is coupled to the cannula piston, wherein the floating flexure strip is movable between a first strip position and a second strip position. McKillip teaches an actuating device 100 with multiple stable positions (i.e., three stable positions) comprising a first flexure member 104 and a second flexure member 106 (see McKillip, figs. 1-3, Col. 4, lines 66-67 – Col. 5, lines 1-6). The first and second flexure members together comprise an active portion of the actuating device (see McKillip, figs. 1-3, Col. 4, lines 66-67 – Col. 5, lines 1-6), and can be configured or arranged with respect to each other to have a number of stable positions that permit actuation of the actuating device (see McKillip, Col. 5, lines 35-51, Col. 5, lines 59-67 – Col. 6, lines 1-27). Therefore, the combination of Williams as modified by McKillip teaches at least one floating flexure strip that is coupled to the cannula piston, wherein the floating flexure strip is movable between a first strip position and a second strip position that constitutes an improvement to the device of Williams as the flexure members are able to move the device into one of a plurality of stable positions for effective exertion of an actuation force against opposing forces (i.e., such as aerodynamic or hydrodynamic forces) (see McKillip, abstract, Col. 3, lines 21-32). As such, claims 21-26 are still rejected under 35 USC 103 over Williams as modified by McKillip. See 35 USC 103 Rejections below.
Claim Objections
Claims 7, 13, 21 and 28 are objected to because of the following informalities:
at claim 7, lines 20-22 “the floating flexure strip coupled to the cannula piston, wherein the floating flexure strip is moveable” should read as -- the at least one floating flexure strip coupled to the cannula piston, wherein the at least one floating flexure strip is moveable--;
at claim 13, line 3, “wherein the at least one distal floating flexure strip comprises at least two distal floating flexure strip” should read as --wherein the at least one distal floating flexure strip comprises at least two distal floating flexure strips--;
at claim 21, line 23, “wherein the floating flexure strip” should read as –wherein the at least one floating flexure strip--;
at claim 28, the claim should end in a period.
Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 21-24 & 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 20120253230-- as previously cited--, hereinafter referenced as "Williams" in view of US Patent 6,220,550 --as previously cited--, hereinafter referenced as "McKillip".
With respect to claim 21, Williams teaches a biopsy device comprising:
(a) a body (i.e., an outer portion of the biopsy device) (see outer portion of device in Williams, fig. 1);
(b) a biopsy needle 20 extending from a distal end of the body (see Williams, fig. 1, par 0022) the biopsy needle comprising:
(i) an outer cannula 24 (see Williams, par 0022, 0025, fig. 1);
and (ii) an inner needle 22 (i.e., an inner member or stylet) slidably disposed within the outer cannula (see Williams, par 0022-0023, 0026, fig. 1, 3A-3B);
(c) an actuation handle 26 extending from a proximal end of the body and removably coupled to the inner needle (see Williams, par 0022-0023, 0025-0028, fig. 1, 3A-3B) the actuation handle comprising::
(i) an elongate handle body 72 (i.e., a housing) moveably disposed at least partially within the body (i.e., the handle body at least partially makes up the body of the biopsy device) (see Williams, fig. 1, 3A-3B);
and (ii) a piston cavity 83 (i.e., a central channel) defined within the elongate body 72 (see Williams, par 0027, figs. 3A-3B); wherein the actuation handle 26 is moveable between a distal handle position, a proximal handle position, and an intermediate handle position (i.e., the handle is moveable between a cocking step that prepares the handle to fire the cannula over the stylet, an insertion step wherein the stylet and cannula are inserted into the body, and a firing step wherein the cannula is released to be rapidly moved forward over the stylet, and to return to the unstressed state) (see Williams, par 0027, 0039, 0041, 0043-0047);
and (d) an actuation mechanism disposed within the body (see Williams, figs. 1, 3A-3B, par 0027, 0031, 0034-0037), the actuation mechanism comprising:
(i) a cannula piston 74 (i.e., a trigger or actuator) moveably disposed within the piston cavity and coupled to the outer cannula such that the outer cannula is axially constrained in relation to the cannula piston (see Williams, figs. 1, 3A-3B, par 0027, 0031, 0034-0037);
and (ii) at least one spring 78 coupled to the cannula piston, wherein the spring is movable between a first position and a second position (i.e., the spring is movable between a compressed position and a relaxed position) (see Williams, fig. 1, par 0027, 0034, 0037, 0039, 0047),
wherein movement of the actuation handle from the intermediate handle position toward the first handle position causes the actuation mechanism to urge the outer cannula distally (see Williams, par 0034, 0039, 0041, 0047).
Williams fails to teach at least one floating flexure strip that is coupled to the cannula piston, wherein the floating flexure strip is movable between a first strip position and a second strip position.
McKillip teaches an actuating device 100 with multiple stable positions (i.e., three stable positions) comprising a first flexure member 104 and a second flexure member 106 (see McKillip, figs. 1-3, Col. 4, lines 66-67 – Col. 5, lines 1-6). The first and second flexure members together comprise an active portion of the actuating device (see McKillip, figs. 1-3, Col. 4, lines 66-67 – Col. 5, lines 1-6), and can be configured or arranged with respect to each other to have a number of stable positions that permit actuation of the actuating device (see McKillip, Col. 5, lines 35-51, Col. 5, lines 59-67 – Col. 6, lines 1-27).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Williams such that it comprises at least one floating flexure strip that is coupled to the cannula piston, wherein the floating flexure strip is movable between a first strip position and a second strip position because flexure members are able to move devices into one of a plurality of stable positions for effective exertion of an actuation force against opposing forces (i.e., such as aerodynamic or hydrodynamic forces) (see McKillip, abstract, Col. 3, lines 21-32).
With respect to claims 22-24, Williams as modified by McKillip teaches the biopsy device of claim 21. Williams as modified by McKillip further teaches when the actuation handle is in the distal handle position and the at least one floating flexure strip is in the first strip position, the outer cannula and the inner needle are disposed in an extended position, when the actuation handle is in the proximal handle position and the at least one floating flexure strip is in the second strip position, the outer cannula and the inner needle are disposed in a retracted position, and when the actuation handle is in the intermediate handle position and the at least one floating flexure strip is in the second strip position, the outer cannula and the inner needle are disposed in a tissue collection position, wherein a distal end of the inner needle extends from the outer cannula such that a tissue collection channel on the inner needle is exposed (i.e., the handle is moveable between a cocking step that prepares the handle to fire the cannula over the stylet, an insertion step wherein the stylet and cannula are inserted into the body, and a firing step wherein the cannula is released to be rapidly moved forward over the stylet, and to return to the unstressed state, and further the flexure can be moved through a number of stable positions that permit actuation) (see Williams, par 0027, 0039, 0041, 0043-0047, see McKillip, Col. 5, lines 35-51, Col. 5, lines 59-67 – Col. 6, lines 1-27).
With respect to claim 26, Williams as modified by McKillip teaches the biopsy device of claim 21. Williams as modified by McKillip further teaches the at least one floating flexure strip is disposed within the body such that a longitudinal axis of the at least one floating flexure strip is not parallel with a longitudinal axis of the biopsy needle (i.e., the flexure can have a configuration that is optimal for the device for which it is used for) (see McKillip, Col. 6, lines 27-56).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of McKillip, as applied to claim 21.
With respect to claim 25, Williams as modified by McKillip does not explicitly teach that the outer cannula is urged distally at a speed ranging from about 1.5 m/s to about 20 m/s and a force ranging from about 15 N to about 75 N.
Nonetheless, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the biopsy device of Williams as modified such that the outer cannula is urged distally at a speed ranging from about 1.5 m/s to about 20 m/s and a force ranging from about 15 N to about 75 N because Williams as modified teaches that a force is applied to the outer cannula 24 by pushing grip 86 that releases the hold on spring 78 which causes its potential energy to be transferred to outer cannula 24 and thereby causes cannula 24 to be thrusted over stylet 22 at a speed (see Williams, par 0037). Therefore, it would merely be a matter of routine optimization to arrive at the speed range of 1.5 m/s to about 20 m/s and the force range of 15 N to 75 N that the outer cannula is thrusted at, since it has been held that "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Routine Optimization A. Optimization within Prior Art Conditions or Through Routine Experimentation.
ALLOWABLE SUBJECT MATTER
The following is a list of pertinent prior art to applicant’s invention:
US Patent Application Publication 2018/0333145, see par 0058, figs. 1 & 5, disclosing a semi-automatic biopsy needle device and methods of use, comprising finger grips 177 used to actuate a cannula and trocar of the biopsy needle device.
US Patent 5,709,697, see figs. 1-5, Col. 4, lines 28-51, disclosing an apparatus and method for removing tissue, comprising grips 148 that facilitate gripping by a user upon actuation of the apparatus.
Regarding claim 7, none of the prior art teaches or suggests, either alone or in combination, at least one floating flexure strip attached to first and second sidewalls of a body, in combination with the other claimed elements.
Regarding claim 27, none of the prior art teaches or suggests, either alone or in combination, at least one floating flexure strip that is attached at a first end to a first side wall of the body and at a second end to a second side wall of the body, in combination with the other claimed elements.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Destiny J Cruickshank whose telephone number is (571)270-0187. The examiner can normally be reached M-F, 9am-6pm.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/D.J.C./Examiner, Art Unit 3791
Prosecution Insights