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 .
This Office action is responsive to the Reply to Office Action filed May 20, 2025. The Examiner acknowledges the amendments to claim 1. Claims 1-9, 11-12 & 14 are currently pending.
Response to Arguments
Applicant’s arguments, see remarks, filed May 20, 2025, with respect to the rejection of the claims under 35 USC 112(b) have been fully considered and are persuasive. The previous rejection of the claims under 35 USC 112(b) has been withdrawn.
However, Applicant’s arguments, see remarks, filed May 20, , with respect to the rejection of the claims under 35 U.S.C. 103 over Devlin in view of Pereira, have been fully considered but they are not fully persuasive. Applicant argues that the jaw base diameter of the claimed invention is 2.0-2.5mm to firmly support the sampling needle without any deformation, whereas Devlin discloses the barb is supported by the control wire of which the diameter is 0.19-0.2mm. Applicant further argues that the barb of Devlin is supported by the control wire and cannot withstand a force as big as the sampling needle that is supported by the jaw base of the claimed invention, and therefore fails to continuously penetrate a first sample and a second sample. Moreover, Applicant argues that Devlin fails to teach a sampling needle with a cylindrical needle body and a conical needle point, with a rear end of the cylindrical needle body being fixed into the third fixing slot and further that Devlin teaches the barb can move lengthwise of the shaft, whereas in the claimed invention the sampling needle cannot move relative to the jaw base. The features upon which applicant relies (i.e., a jaw base that has a diameter of 2.0-2.5mm, a jaw assembly of biopsy forceps that is configured to continuously penetrate a first sample and a second sample, and a sampling needle that cannot move relative to the jaw base) 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). Regarding the limitations pertaining to the shape of the sampling needle (i.e., the cylindrical needle body and the conical needle point) and the shape of the limiting element (i.e., the limiting element is a cylindrical structure), the Examiner agrees that Devlin in view of Pereira fails to teach those limitations. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art references that teach the newly added limitations in the claims. See 35 USC 103 rejections below.
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) 1-9, 11-12 & 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent 5238002 – as previously cited--, hereinafter referenced as "Devlin", in further view of US Patent Application Publication 20170079638 --as previously cited--, hereinafter referenced as "Pereira", US Patent 8062306, hereinafter referenced as “Nobis”, and US Patent Application Publication 20070073185, hereinafter referenced as “Nakao”.
With respect to claim 1, Devlin teaches a jaw assembly (see Devlin, fig. 3) of biopsy forceps, comprising:
a jaw base 36 (i.e., a tubular clevis) (see Devlin, Col. 3, lines 46-52, fig. 3), a first jaw 20, a second jaw 20 (i.e., a pair of biopsy jaws) (see Devlin, Col. 2, lines 52-65, fig. 3), a limiting element 80 (i.e., a camming pin) (see Devlin, Col. 4, lines 31-57, fig. 3), a pulling member 14 (i.e., a control wire) (see Devlin, Col. 2, lines 49-56, Col. 3, lines 36-45, fig. 3), and a shaft member 48 (i.e., a pivot pin) (see Devlin, Col. 3, lines 53-67, fig. 3 & 7),
wherein the jaw base comprises a hollow tube 36 (i.e., a tubular clevis) (see Devlin, Col. 3, lines 46-52, figs. 3 & 6), a first arm 44 (i.e., an arm of a pair of arms that fits between slots 40 & 42), and a second arm 44 (i.e., an arm of a pair of arms that fits between slots 40 & 42) (see Devlin, Col. 4, lines 15-30, figs. 3 & 7), which are integrally formed, the first arm and the second arm standing oppositely at a front end of the hollow tube (see Devlin, fig. 7), and an elongated slot (i.e., an elongated interior portion of the hollow tube of the jaw base) (see Devlin, fig. 7) between the first arm and the second arm for accommodating the first jaw and the second jaw;
the first jaw and the second jaw are openable and closeable (see Devlin, Col. 2, lines 53-56, figs. 3 & 4), and are movably arranged in the elongated slot of the jaw base (see Devlin, figs. 3-7);
a rear end 50 (i.e., a proximal segment of the arms of each jaw) (see Devlin, Col. 3, lines 56-67) of the first jaw and a rear end 50 (i.e., a proximal segment of the arms of each jaw) (see Devlin, Col. 3, lines 56-67) of the second jaw are relatively rotatably connected with a front end 62 (i.e., a proximal end of the pulling member 14) of the pulling member 14 (see Devlin, Col. 4, lines 1-14, figs. 3 & 7), and the pulling member 14 extends rearward within a cavity of the hollow tube (see Devlin, figs. 3 & 7);
the limiting element 80 is arranged between the first jaw and the second jaw (see Devlin, fig. 3-4), two ends of the limiting element are respectively fixed to front ends of the first arm 44 and the second arm 44 (i.e., the pin is fixed to cam surfaces of the front ends of the arms such that when the control wire 14 is pulled, the pin urges the cam surfaces proximally or distally to open/close the arms) (see Devlin, figs. 5 & 7, Col. 4, lines 31-57), and the limiting element 80 is configured to limit a maximum stroke of the pulling member 14 pushing forward (see Devlin, fig. 3);
a sampling needle 58, 64 (i.e., a barb with a sharpened tip/point) is fixed in the limiting element 80 to facilitate penetration and sample storage (i.e., a sharpened point is at a distal end of the barb that is fixed to the limiting element, to facilitate penetration and sample storage) (see Devlin, figs. 3-4 & 7, Col. 4, lines 1-14 & lines 58-66);
and the first jaw 20 and the second jaw 20 are individually provided with a ramp 68, 70 (i.e., an inwardly and outwardly facing camming surface) for being matched with the limiting element 80 to open or close the first jaw and the second jaw (see Devlin, Col. 4, lines 31-57, figs. 3 & 4), the ramps 68, 70 on the first jaw 20 and the second jaw 20 abut against both sides of the limiting element 80 respectively, and are slidable relative to the limiting element 80 (see Devlin, figs. 1-3, Col. 4, lines 31-57).
Devlin fails to teach the middle of the limiting element is provided with a third fixing slot, and an opening of the third fixing slot faces forwardly to fix a rear end of the sampling needle.
Pereira teaches a knotting device that comprises a needle 240 disposed within a slot 218 for stabilization of the needle when it is coupled to a groove 201 (see Pereira, par 0070, figs. 2 & 7). The slot has an opening for receiving the needle 240 and the opening faces forwardly (see Pereira, fig. 7).
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 system of Devlin such that the middle of the limiting element is provided with a third fixing slot, and an opening of the third fixing slot faces forwardly to fix a rear end of the sampling needle, because that would permit stabilization of the needle via the limiting element (see Pereira, par 0070, figs. 2 & 7).
Devlin as modified by Pereira fails to teach neither the limiting element is a cylindrical structure arranged between the first jaw and the second jaw, nor the sampling needle includes a cylindrical needle body and a conical needle point.
Nobis teaches manually articulating devices, wherein in an embodiment a cylindrical element 22 (i.e., a second link) is coupled to an end effector 14 comprising two jaws 18a, 18b (see Nobis, figs. 1A & 1B, Col. 4, lines 47-67 – Col. 5, lines 1-7). The cylindrical element 22 permits lateral movement of the end effector 14 in a single plane, which enables the manually articulating device to be used in surgical environments for biopsy (see Nobis, Col. 1, lines 47-58, Col. 5, lines 45-58).
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 system of Devlin as modified by Pereira such that it comprises a limiting element that is a cylindrical structure arranged between the first jaw and the second jaw, because a limiting element that is a cylindrical structure arranged between the first jaw and the second jaw permits lateral movement of jaws of a device, which enables the device to be articulated in surgical environments for biopsy (see Nobis, Col. 1, lines 47-58, Col. 5, lines 45-58).
Devlin as modified by Pereira and Nobis fails to teach the sampling needle includes a cylindrical needle body and a conical needle point.
Nakao teaches needle biopsy forceps with an integral sample ejector that comprises a needle 11 that is cylindrical in shape and has a conical point, wherein the needle is positioned inside of cups at a distal end of the needle biopsy forceps (see Nakao, par 0052, figs. 1 & 8). The needle permits penetration of tissue which can be retained inside the cups after penetration (see Nakao, par 0052).
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 system of Devlin as modified by Pereira and Nobis such that the sampling needle includes a cylindrical needle body and a conical needle point because a sampling needle including a cylindrical needle body and a conical needle point permits penetration of tissue for sampling during biopsy (see Nakao, par 0052).
With respect to claim 2, Devlin as modified by Pereira, Nobis, and Nakao teaches the jaw assembly of biopsy forceps according to claim 1. Devlin further teaches that a distance between the ramp 68, 70 of the first jaw 20 and the ramp 68, 70 of the second jaw 20 is gradually reduced to the rear end of the first jaw 20 and the rear end of the second jaw 20 (i.e., the ramps are angular such that the space between the two ramps of each jaw is smaller at the rear ends of the jaws as opposed to the front ends of the jaws) (see Devlin, fig. 3).
With respect to claim 3, Devlin as modified by Pereira, Nobis, and Nakao teaches the jaw assembly of biopsy forceps according to claim 2. Devlin further teaches that the ramp 68, 70 of the first jaw 20 or the second jaw 20 is located in front of the shaft member 48 (see Devlin, fig. 3).
With respect to claim 4, Devlin as modified by Pereira, Nobis, and Nakao teaches the jaw assembly of biopsy forceps according to claim 2. Devlin further teaches that a minimum distance between the ramp 68, 70 of the first jaw 20 and the ramp 68, 70 of the second jaw 20 is between the limiting element 80 and the shaft member 48 (i.e., the limiting element and shaft member are contained within the smallest distance between the two ramps of each jaw) (see Devlin, fig. 4).
With respect to claim 5, Devlin as modified by Pereira, Nobis, and Nakao teaches the jaw assembly of biopsy forceps according to claim 4. Devlin further teaches that the minimum distance is smaller than a size of the limiting element 80 located between the ramp 68, 70 of the first jaw 20 and the ramp 68, 70 of the second jaw 20 (i.e., the minimum distance between the ramps is smaller than a size of the limiting elements located between the ramps, such as no distance between the two ramps) (see Devlin, fig. 4).
With respect to claim 6, Devlin as modified by Pereira, Nobis, and Nakao teaches the jaw assembly of biopsy forceps according to claim 4. Devlin further teaches that the first arm 44 is provided with a first fixing slot 40, the second arm is provided with a second fixing slot 42 (see Devlin, Col. 4, lines 15- 30, fig. 7), both ends of the limiting element 80 are fixed to the first fixing slot 40 and the second fixing slot 42 respectively (see Devlin, fig. 7, wherein the limiting element is fixed perpendicularly to the first and second fixing slots), and the first fixing slot and the second fixing slot are less than the elongated slot in depth (see Devlin, fig. 7).
With respect to claim 7, Devlin as modified by Pereira, Nobis, and Nakao teaches the jaw assembly of biopsy forceps according to claim 2. Devlin further teaches that the first jaw and the second jaw individually comprise a jaw spoon 46 and a handle (i.e., the portion of the jaw body below the jaw spoon) (see Devlin, fig. 7), which are integrally formed, the handle comprises a handle body 52 (i.e., an outwardly offset intermediate segment) (see Devlin, fig. 7) and a connecting portion 50 (see Devlin, Col. 3, lines 53-68), and the handle body 52 is configured to connect the jaw spoon 46 and the connecting portion 50 (see Devlin, fig. 7); and the first jaw and the second jaw are relatively rotatably connected at the connecting portion (i.e., the first and second jaw are pivotable at the connection portion) (see Devlin, Col. 3, lines 53-68).
With respect to claim 8, Devlin as modified by Pereira, Nobis, and Nakao teaches the jaw assembly of biopsy forceps according to claim 7. Devlin further teaches that the jaw spoon 46, the handle 52, and the connecting portion 50 are integrally formed along a straight line to form a rigid structure (i.e., a straight line is formed at the jaw spoon as a result of the handle and connecting portion, to permit a rigid structure of the jaw spoon) (see Devlin, fig. 7).
With respect to claim 9, Devlin as modified by Pereira, Nobis, and Nakao teaches the jaw assembly of biopsy forceps according to claim 7. Devlin further teaches that the connecting portion 50 connects the first jaw 20 and the second jaw 20 (i.e., the connecting portion 50 permits the connection of the first and second jaw via pivot pin 48) (see Devlin, fig. 7) and is connected to the pulling member 14 (i.e., the connecting portion connects the first and second jaw to the pulling member 14 via a proximal end of a barb 58) (see Devlin, fig. 7, Col. 4, lines 1-14) and the connecting portion 50 and the pulling member 14 together move forward or rearward relative to the jaw base 36 (see Devlin, fig. 3).
With respect to claim 11, Devlin as modified by Pereira, Nobis, and Nakao teaches the jaw assembly of biopsy forceps according to claim 1. Devlin further teaches that the rear end of the first jaw 20 and the rear end of the second jaw 20 have opposite portions in inclined contour (i.e., the rear end of the jaws near the jaw base have portions opposite each other that are in an inclined contour configuration) (see Devlin, fig. 3).
With respect to claim 12, Devlin as modified by Pereira, Nobis, and Nakao teaches the jaw assembly of biopsy forceps according to claim 1. Devlin further teaches that the pulling member 14 comprises a pull rod 18 (i.e., actuating means) (see Devlin, fig. 1, Col. 3, lines 28-45) and a connecting tube 22 (i.e., a stationary member that connects the pulling member to the pull rod) (see Devlin, fig. 1, Col. 3, lines 28-45), a front end of the pull rod 18 is provided with an annular connecting portion 31 (i.e., a point of attachment), and the pull rod 18 is inserted into a front end of the connecting tube 22 to be fixed (see Devlin, fig. 1, Col. 3, lines 28-45),
the annular connecting portion 31 (i.e., point of attachment) is arranged at a front end of the pull rod 18, and the shaft member 48 penetrates through the annular connecting portion 31 to realize riveting of the pulling member with the first jaw 20 and the second jaw 20 (i.e., the pivot pin is connected to the control wire of the actuating means which penetrates through the point of attachment to realize riveting of the first jaw and the second jaw when the control wire is actuated) (see Devlin, figs. 1-3, Col. 3, lines 28-45 & lines 53-68, Col. 4, lines 1-14 & 31-57).
With respect to claim 14, Devlin as modified by Pereira, Nobis, and Nakao teaches a biopsy forceps, comprising the jaw assembly according to claim 1 (see above). Devlin further teaches:
a spring tube 12 (i.e., a helical coil), a controlling wire 14 (i.e., a control wire), and an operating handle 24 (see Devlin, figs. 1-2, Col. 2, lines 44-65, Col. 3, lines 28-45) wherein a front end of the spring tube is fixed to a rear end of the jaw base (see Devlin, figs. 1 & 2), a rear end of the spring tube is fixed to the operating handle (see Devlin, figs. 1 & 2), a rear end of the pulling member is fixed to a front end of the controlling wire, the controlling wire extends rearward through the spring tube 12 (see Devlin, figs. 1 & 2), and a rear end of the controlling wire is fixed to the operating handle 24 (see Devlin, figs. 1 & 2).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/D.J.C./Examiner, Art Unit 3791