DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 20, 2026 has been entered.
The Examiner acknowledges the amendments to claims 1, 8 and 9, as well as the cancellation of claim 7. Claim 10 is listed in the claim set as “Withdrawn,” but the claim was previously canceled by way of the Amendment filed February 5, 2025. Claim 10 will continue to be considered “Canceled”. Claims 1-6, 8, 9 and 11-14 are pending, while claim 13 remains Withdrawn from consideration.
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 .
Response to Arguments
In response to applicant's argument that the Devlin reference fails to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., insufficient storage space to support continuous two-time sampling, insufficient cutting force to sever tissue when closed, and miniaturization) are not recited in the rejected claims. 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).
Applicant's arguments regarding the applied references as they pertain to the “inclined contour” limitations have been fully considered but they are not persuasive. The limitation is deemed indefinite for the reasons set forth below.
Applicant’s remaining arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “rear end of the first jaw and the rear end of the second jaw [having] opposite portions in inclined contour” as recited in Amended Claim 1 must be shown or the features canceled from the claims. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1 and 12 are objected to because of the following informalities:
At claim 1, line 33, “handles” should read --handle--.
At claim 12, the limitation “the annular connecting portion is arranged at a front end of the pull rod” as recited at line 5 effectively repeats the limitation at lines 2-3 of the same claim.
Appropriate correction is required.
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.
Claims 1-6, 8, 9, 11, 12 and 14 are 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.
Regarding claim 1, the claim does not define how the “shaft member” recited at line 2 relates to the other elements of the forceps. While the specification points to reference character 5 (“rivet” illustrated in Fig. 4), the claim language is open to many possible interpretations that are potentially far removed from this element, including the proximal shaft of piercing element 8, the rod 6, or the tube 7, among others. This lack of clarity is compounded in claims 3, 4, and 12 which attempt to relate other elements of the forceps to the shaft member positioning.
Further regarding claim 1, the limitation “the rear end of the first jaw and the rear end of the second jaw [having] opposite portions in inclined contour” recited at lines 21-22 renders the claim indefinite. This feature is not illustrated in the drawings and is only described at the first paragraph of page 13 of the specification as “a contour of the rear end of the connecting portion 233 near the inner side (emphasis added) has an inclined structure. That is, opposite portions of the rear end of the first jaw 203 and the rear end of the second jaw 204 have an inclined contour.” It is unclear from that disclosure how the limitation is intended to define over the prior art. For example, while an inclined contour might be interpreted to lean, be angled or have a slope, the disclosure is unclear as to where that inclined contour is intended to occur. It does not appear that the inner sides of the connecting portions themselves are inclined, so is the contour on an upper outer side, a lower outer side, or an end surface/face of the rear end? Moreover, while opposite portions of the rear ends of the respective jaws have inclined contours, it is unclear whether the respective inclined contours interact with each other or serve any particular purpose.
Further regarding claim 1, the limitation “the same arc-shaped cross section in the length direction” at lines 30-31 renders the claim indefinite. It is unclear from the disclosure how the phrase “the same” is intended to limit the claim. Is this intended to indicate that the same arc-shaped cross section is present continuously along the length of the “handle body” or that the handle bodies of the respective jaws are intended to have cross sections that mirror one another in the same arc-shape?
Regarding claim 6, the limitation “both ends of the limiting element” renders the claim indefinite. It is unclear whether the limiting element has only the two ends defined at line 12 of claim 1, or if the limiting element has other previously undefined ends, e.g. a top end, bottom end, front end, back end, left end, right end, etc.
Regarding claim 8, it is unclear whether the limitations recited pertain to both the first jaw and the second jaw or to a particular one of the first jaw and the second jaw.
Further regarding claim 8, the limitation “the jaw spoon, the handle, and the connecting portion are integrally formed” renders the claim indefinite as the connecting portion is defined at line 26 of claim 1 as part of the handle. It is unclear whether “the handle” at line 3 of claim 8 should read --the handle body--.
Regarding claim 9, it is unclear whether the limitations recited pertain to both the connection portions of both the first jaw and the second jaw or to the connecting portion of a particular one of the first jaw and the second jaw.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 11 repeats the limitations recited at lines 21-22 of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-6, 8, 9, 11, 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Devlin (U.S. 5,238,002) in view of Gundberg et al. (U.S. 10,441,253), and further in view of Taylor (U.S. 6,419,640).
Regarding claims 1 and 11, 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 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 52,54 (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). The jaw spoon is wider than the handle body (see Delvin, fig. 6). 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. 7, lengthwise, outwardly-facing segment at 50).
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.
Gundberg et al. teach an endoscopic device for multiple sample biopsy. The device includes a forceps having a first jaw 20 and a second jaw 21, as well as a needle-shaped collecting member 30 with a conical point and cylindrical body mounted in a slot in coupling 33 between the jaws.
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 to substitute a needle-shaped collecting member similar to that of Gundberg et al. for the needle barb of Devlin, such that the needle-shaped collecting member is mounted in a fixing slot in the middle of the limiting element of Devlin as taught by Gundberg et al. in order to allow the collecting member to be easily removed from the stem and remainder of the forceps and allow the collecting member with multiple samples transfixed thereon to be removed for the distal end through the open jaws (see at least Gundberg et al., column 14, lines 35-51).
Devlin as modified by Gundberg et al. fails to teach the handle body has the same arc-shaped cross section in the length direction, and protrudes outwardly of the jaw spoon to form an inwardly facing groove in which a sample may be stored on the sampling needle between the jaw spoons and the handle bodies.
Taylor teaches a multiple-specimen, endoscopic biopsy forceps having a pair of jaws, where each jaw has a handle body 218 with a same arc-shaped cross section (see at least fig. 9) connecting a jaw spoon 220 and a connecting portion 208, where the handle body protrudes outwardly of the jaw spoon to form an inwardly facing groove in which a sample may be stored on the sampling needle 200 between the jaw spoons and the handle bodies (see at least fig. 10).
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 handle bodies of Devlin as modified by Gundberg et al. to have the same arc-shaped cross section in the length direction and protrude outwardly of the jaw spoon to form an inwardly facing groove in which a sample may be stored on the sampling needle between the jaw spoons and the handle bodies in order to increase the capacity of the biopsy device by allowing sufficient space for retention and storage of multiple specimens transfixed on the stylet (see at least Taylor, column 5, lines 47-65).
Regarding claim 2, Devlin as modified by Gundberg et al. and Taylor 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).
Regarding claim 3, Devlin as modified by Gundberg et al. and Taylor teach 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).
Regarding claim 4, Devlin as modified by Gundberg et al. and Taylor 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).
Regarding claim 5, Devlin as modified by Gundberg et al. and Taylor 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).
Regarding claim 6, Devlin as modified by Gundberg et al. and Taylor 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).
Regarding claim 8, Devlin as modified by Gundberg et al. and Taylor teaches the jaw assembly of biopsy forceps according to claim 1. 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).
Regarding claim 9, Devlin as modified by Gundberg et al. and Taylor teaches the jaw assembly of biopsy forceps according to claim 1. 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).
Regarding claim 12, Devlin as modified by Gundberg et al. and Taylor 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).
Regarding claim 14, Devlin as modified by Gundberg et al. and Taylor 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sharma (U.S. 12,023,013), Wolfe (U.S. 2015/0313581), and Hugueny (U.S. 6,425,910) teach biopsy forceps having a pair of jaws and a piercing needle disposed therebetween.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Charles A Marmor, II whose telephone number is (571)272-4730. The examiner can normally be reached Monday-Friday 9AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jonathan Moffat can be reached at (571) 272-4390. 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
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