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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/22/2025 has been entered.
Response to Arguments
Applicant’s arguments, filed 12/22/2025, with respect to the amendments overcoming the previous 35 USC 102a2 rejections over Malkowski et al. have been fully considered and are persuasive. The 35 USC 102a2 rejection of claims 28-46 over Malkowski has been withdrawn. In view of the amendments, new rejections are presented below.
Claim Objections
Claims 37-46, 49 and 50 are objected to because of the following informalities: in lines 13-14 of claim 37, “the rotation of the actuator” should read “the rotation of the portion of the actuator that extends radially out from the gear cylinder” for consistency with lines 11-12 of claim 37, noting it is understood that “the rotation” refers to the previously recited step of rotating. Claims 38-46, 49 and 50 are objected to by virtue of their dependence from claim 37. 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 49 and 50 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.
Claims 49 and 50 depend from method claim 37, but recite the preamble “The surgical instrument of claim….”, thus rendering the scope of claims 49 and 50 indefinite. As best understood, the preamble of claim 49 should read “The method of claim 37” and the preamble of claim 50 should read “The method of claim 49”, and have been thus treated for purposes of claim interpretation.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 28-29, 34-36, and 47-48 is/are rejected under 35 U.S.C. 102a2 as being anticipated by Baril et al. (US 2019/0038375). Baril discloses a surgical instrument comprising: a handle (12; fig. 1a); an elongated shaft assembly (14) extending distally from the handle, the elongated shaft assembly configured to receive a plurality of fasteners (clips “C”; fig. 1b) therein; a trigger (18; fig. 2) movably coupled to the handle, the trigger movable between an actuated position and an unactuated position ([0021]); and a fastener deployment system (e.g., 28,26,23) operatively coupled to the trigger and the elongated shaft assembly, the fastener deployment system configured to deploy a fastener of the plurality of fasteners from the elongated shaft assembly in response to movement of the trigger from the unactuated position to the actuated position ([0021]), wherein the handle includes a fastener level indicator system (200) configured to indicate a number of fasteners of the plurality of fasteners that remain within the elongated shaft assembly ([0022]), the fastener level indicator system comprising: an indicator comprising a gear cylinder (252, noting actuating features 256); and an actuator (202a, 230,260) positioned at least partially within the gear cylinder (noting post 206 of 202a is positioned within the gear cylinder) wherein the actuator includes a portion (230) that extends radially out from the gear cylinder (figs. 5a-5c), operatively coupled to the trigger and the indicator such that movement of the trigger from the unactuated position to the actuated position (from fig. 5A-5C) causes the portion (230) that extends radially out from the gear cylinder to rotate (see figs. 5b-5c, noting 230 rotates about pin 226c; see [0043]-[0044]) and change a position of the indicator by rotating the indicator (from fig. 5a-5b).
Regarding claim 29, the actuator comprises a first tooth (any one of teeth 208 on post 206 of 202a), and wherein the gear cylinder includes internal gear teeth (264; [0033]) located on an interior of the gear cylinder (fig. 3b), the first tooth configured to engage the internal gear teeth such that the indicator is configured to rotate in response to a movement of the actuator (of portion 230 of the actuator) when the first tooth is engaged with the internal gear teeth (fig. 4a, 4b; note that internal gear teeth 264 are not illustrated in figs. 5a-5c, but are present; the internal gear teeth will ride over first tooth during rotation of indicator; see [0036]).
Regarding claim 34, the fastener level indicator system further comprises a window (24; fig. 1, 2) formed in the handle, wherein a viewable portion of the indicator is configured to be viewed through the window ([0023], [0047]).
Regarding claim 35, the viewable portion of the indicator is configured to indicate the number of fasteners of the plurality of fasteners that remain within the elongated shaft assembly based on the position of the indicator ([0011]).
Regarding claim 36, the viewable portion of the indicator is an upper surface of the gear cylinder (fig. 1, 2, 3c, noting this is dependent on orientation of device).
Regarding claim 47, the surgical instrument of Baril further comprises a reciprocating arm (240; [0039]) configured to move in response to movement of the trigger and including a cam track (aperture 246a or 246b) wherein a portion (230) of the actuator that extends radially out from the gear cylinder includes a pin (226c), wherein movement of the reciprocating arm (240) causes movement of the pin (226) that rotates the indicator (252) (see fig. 5a to 5b).
Regarding claim 48, movement of the trigger causes linear reciprocating movement of the reciprocating arm (240) (along slot 218; see figs. 5a to 5b; [0039]).
Claim(s) 28 and 34-42 is/are rejected under 35 U.S.C. 102a2 as being anticipated by Sadler et al. (US 2004/0167545). Sadler discloses a surgical instrument comprising: a handle (see fig. 1); an elongated shaft assembly (unnumbered, but shown in fig. 1) extending distally from the handle, the elongated shaft assembly configured to receive a plurality of fasteners (clips; [0042]) therein; a trigger (100) movably coupled to the handle, the trigger movable between an actuated position and an unactuated position ([0075]); and a fastener deployment system (e.g., 1008) operatively coupled to the trigger and the elongated shaft assembly, the fastener deployment system configured to deploy a fastener of the plurality of fasteners from the elongated shaft assembly in response to movement of the trigger from the unactuated position to the actuated position ([0074]), wherein the handle includes a fastener level indicator system (400) configured to indicate a number of fasteners of the plurality of fasteners that remain within the elongated shaft assembly ([0016], [0058]), the fastener level indicator system comprising: an indicator comprising a gear cylinder (426; figs. 5, 13); and an actuator (402 and 425; fig. 7,13 ) positioned at least partially within the gear cylinder (noting 4026 of 402, in fig. 7, is received in gear cylinder 426 as understood in view of fig. 5) wherein the actuator includes a portion (425) that extends radially out from the gear cylinder (fig. 13), operatively coupled to the trigger and the indicator such that movement of the trigger from the unactuated position to the actuated position causes the portion (425) that extends radially out from the gear cylinder to rotate ([0082]) and change a position of the indicator by rotating the indicator ([0082]).
Regarding claim 34, the fastener level indicator system further comprises a window (410) formed in the handle, wherein a viewable portion of the indicator (426) is configured to be viewed through the window ([0058]).
Regarding claim 35, the viewable portion of the indicator is configured to indicate the number of fasteners of the plurality of fasteners that remain within the elongated shaft assembly based on the position of the indicator ([0058], [0056]).
Regarding claim 36, the viewable portion of the indicator is an upper surface of the gear cylinder (noting this is dependent on orientation of device, device may be held such that viewable portion forms upper surface of the gear cylinder).
Regarding claim 37, Sadler discloses a method of operating a surgical instrument, the method comprising: moving a trigger (100) of the surgical instrument from an unactuated position to an actuated position to deploy a fastener of a plurality of fasteners (clips) from an elongated shaft assembly (unnumbered, but shown in fig. 1) of the surgical instrument, wherein moving the trigger rotates an actuator (rotates portion 425 of actuator 402,425); and moving an indicator (426) of the surgical instrument from a first position to a second position to indicate a number of fasteners of the plurality of fasteners that remain within the elongated shaft assembly ([0016], [0056], [0059]), wherein the indicator comprises a gear cylinder (426), wherein the actuator is positioned at least partially within the gear cylinder (note post 4026 of 402 in fig. 7; which fits inside gear cylinder as understood in view of fig. 5) and includes a portion (425; fig. 5 and 13) that extends radially out from the gear cylinder, and wherein moving the indicator from the first position to the second position comprises rotating, in response to the movement of the trigger, the portion (425) of the actuator that extends radially out from the gear cylinder ([0049]), and moving, in response to the rotation of the actuator (in particular, portion 425 of actuator), the indicator with the actuator (rotation of 425 causes rotation of 426 through intermeshed teeth; [0082]).
Regarding claim 38, moving the indicator further comprises moving a viewable portion of the indicator (426) relative to a window (410) of the surgical instrument, the viewable portion configured to be viewed through the window ([0058]).
Regarding claim 39, the viewable portion of the indicator is configured to indicate the number of fasteners of the plurality of fasteners that remain within the elongated shaft assembly based on the position of the indicator ([0056], [0058]).
Regarding claim 40, the viewable portion of the indicator is an upper surface of the gear cylinder (noting "upper" surface is dependent on orientation in which the device is being held, and the device may be held such that the surface on which the viewable portion is located forms the “upper” surface of the gear cylinder).
Regarding claim 41, moving the indicator further comprises moving a reciprocating arm (406; see arrow 407 in fig. 9 and arrow 416 in fig. 4) operatively coupled to the trigger and the indictor to rotate the indicator ([0068], [0075]).
Regarding claim 42, moving the indicator further comprises moving the actuator (at least portion 425) operatively coupled to the reciprocating arm (via 422,424) and the gear cylinder (426) to rotate the gear cylinder ([0082]).
Allowable Subject Matter
Claims 30-33 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The closet prior art of Baril fails to disclose, in combination with the other limitations as discussed with respect to claim 29 above, the first tooth (any one of teeth 208) being disposed on a resilient arm of the actuator. The prior art of Sadler fails to disclose, in combination with the limitations of claim 28 as discussed above, that the gear cylinder includes internal gear teeth located on an interior of the gear cylinder.
Claims 43-46 are objected to for the minor informality above and as being dependent upon a rejected base claim, but would be allowable if rewritten to address the minor informality associated with claim 37 and in independent form including all of the limitations of the base claim and any intervening claims. The closest prior art of Sadler fails to disclose, in combination with the remaining limitations of claims 43-46, at least that the gear cylinder includes internal teeth located on an anterior of the gear cylinder. The prior art of Baril fails to expressly disclose the step of “moving, in response to the rotation of the actuator, the indicator with the actuator” (see claim 37, from which claims 43-46 depend). Although Baril discloses that movement of the trigger from the actuated position to the actuated position causes the portion (230) of the actuator that extends radially out from the gear cylinder to rotate (from fig. 5b to fig. 5c) and change a position of the indicator by rotating the indicator (from fig. 5a-5b), the indicator is not moved in response to the rotation of the actuator. Instead, the indicator is moved (rotated) in response to the linear motion of the portion 230 of the actuator (from fig. 5a to 5b), and the rotation of the actuator (from fig. 5b to 5c) does not move the indicator.
Claims 49 and 50 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. The closest prior art of Sadler discloses the method of claim 37 as discussed above, but fails to disclose the additional limitations of claims 49 and 50.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
EP 1304079 A1 to Giddins: paragraph [0004] of Sadler (US 2004/0167545) indicates that the invention of Saddler finds particular but not exclusive use in ensuring the performance of an applications such as described in British patent application No. 9919170.2, which corresponds to EP 1304079A1. Note that multiple clips (140) are housed in the shaft assembly.
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KSH 2/25/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771