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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "72" (See FIG 3) and "82" (See FIG 4 and 5) have both been used to designate a retention clip. 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. 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 Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 5-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gold et al. (US 2020/0352572).
Regarding claim 1, Gold et al. discloses a clamping system (FIG 6, paragraph [0028], including the clamp and drive elements of FIG 2, paragraph [0023]), comprising: a clamp head (604) having a housing (See annotated FIG 2 below) with a tubular neck (Tubular proximal portion of 604 including cylindrical v-groove 606, see annotated FIG 2 below), a first jaw (Left arm as viewed in FIG 6, or 206, FIG 2) that extends from the housing (FIG 2 shows a proximal portion of the arm extends distally from the housing), a second jaw (Right arm as viewed in FIG 6, or 204, FIG 2) that extends from the housing (FIG 2 shows a proximal portion of the arm extends distally from the housing), and a drive shaft (212) that extends into said housing (FIG 2 shows via dashed lines that 212 extends into the housing and forms worm 200, [0023]) through said tubular neck (FIG 2, the dotted lines show 212 extends through the tubular neck), wherein said first jaw can be moved relative said second jaw by rotating said drive shaft (Paragraphs [0023 and 0028]); forceps (600) that open and close ([0028]), said forceps having a ring clamp (602) thereon that opens and closes with said forceps (Due to being mechanically connected to one another, paragraph [0028]), and wherein said ring clamp is sized to receive and retain said tubular neck on said clamp head (Paragraph [0028]; “For example, distal portion 602 is shown to be curved in FIG. 6 so that it may grasp clamp 604 along its cylindrical V-groove 606 when control arms 608 are approximated (to bring them together).”); and a mechanical actuator (610, paragraph [0028] discloses this element is similar to the clamp applier of FIG 5, paragraph [0027]) supported by said forceps (FIG 6 shows the connection of the assembled apparatus such that 610 is supported by its attachment to the forceps), wherein said mechanical actuator has an elongated shaft (616) that aligns with said drive shaft when said ring clamp on said forceps is closed around said tubular neck of said clamp head (614 engages with 212; when the ring clamp is closed around the tubular neck, the drive shaft and elongated shaft are axially aligned with one another).
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Regarding claim 5, Gold et al. discloses said section jaw is stationary relative to said housing (jaw 204 is constrained to the housing and does not pivot or move relative thereto), and said first jaw is moved by rotating said drive shaft ([0023]).
Regarding claim 6, Gold et al. discloses said elongated shaft of said mechanical actuator extends along a central axis (Shown as the dashed line in FIG 6) and said mechanical actuator includes a handle (618) for selectively rotating said elongated shaft about said central axis and reciprocally moving said elongated shaft along said central axis (Paragraph [0028] rotation of 618 rotates the elongated shaft 616 and therefore drive shaft 212. Rotation of 212 also results in reciprocation).
Regarding claim 7, Gold et al. discloses said elongated shaft terminates with an engagement head (614) that moves with said elongated shaft (Paragraph [0028] discloses the elements are fixedly connected and therefore move together), wherein said elongated shaft selectively interconnects with said drive shaft of said clamp head when said ring clamp on said forceps is closed around said tubular neck of said clamp head (Paragraph [0028]; “In use, after clamp 604 has been positioned, the drive head 614 releasably engages any part of a rotationally actuated drive element, e.g., the drive shaft (212) in FIG. 2”).
Regarding claim 8, Gold et al. discloses said first jaw rotates about a pivot pin (220, paragraph [0023]).
Regarding claim 9, Gold et al. discloses said first jaw includes a pinion gear (202, including teeth 216) that rotates about said pivot pin (Paragraph [0023]).
Regarding claim 10, Gold et al. discloses said clamp head includes a worm gear (200, including gear teeth 218, FIG 2) that is rotated by said drive shaft (Paragraph [0023]), wherein said worm gear turns said pinion gear and moves said first jaw (Paragraph [0023 and 0028]).
Regarding claim 11, Gold et al. discloses said forceps includes a first shank (One of 608, 612) and a second shank (The other of 608, 612) joined at a scissor joint (Rotation point at areas identified as 610 in FIG 6), wherein said ring clamp includes a first half ring on said first shank (Bottom ring half which connects to 612 of the first shank) and a second half ring on said second shank (Top ring half which connects to 612 of the second shank).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 2-4 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Gold et al. (US 2020/0352572) in view of Whitfield et al. (US 2019/0200971).
Regarding claims 2-4, Gold et al. discloses the invention substantially as claimed, as set forth above for claim 1.
Gold et al. is silent regarding said first jaw being selectively detachable from said housing and held attached to said housing with a removable retention clip, wherein said first jaw has hinge pins extending therefrom that are received by said housing, wherein said removable retention clip engages said hinge pins, and wherein at least one tab extends from said retention clip to provide an accessible point for engaging said retention clip with a secondary surgical instrument.
However, Whitfield et al. teaches a clamping system (FIG 45-46) having a clamp head (100, [0066], FIGs 3-4. [0110] discloses that 300 is substantially similar to 100, with the difference being the location of the shipping lock. Therefore, the components of the jaws and housing member are understood to be the same as what is disclosed in relation to 100) having a pivotable first jaw (116, including 164, FIG 5) selectively detachable from a housing (Wherein the proximal base of 150 forms the housing, and 164 is pivotably secured thereto by screws 168, [0080] and is therefore selectively detachable because the screws can be removed) and held attached to said housing with a removable retention clip (400, FIGs 45, 46, and 50, [0120-0124]. The hinge pins are shown but not numbered in FIG 43-44. Lock 400 covered the pins as shown in FIG 45-46, therefore the first jaw is held attached to the housing because the jaw could not be removed when 400 is covering the hinge pins), wherein said first jaw has hinge pins (168) extending therefrom that are received by said housing (Openings 151a, [0080]), wherein said removable retention clip engages said hinge pins (By covering the pins, FIG 45-46), and wherein at least one tab (404) extends from said retention clip (FIG 46) to provide an accessible point for engaging said retention clip with a secondary surgical instrument ([0121-0122] discloses 404 is configured to grasped by a user but is also at least sized and shaped to be configured to engage with a secondary surgical instrument).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the clamping head of Gold et al. such that the first jaw is selectively detachable from the housing via hinge pins and to comprise a removable retention clip (i.e. a shipping lock), as taught by Whitfield, for the purpose of supplying the clamping system with a mechanism for preventing premature articulation of the jaws relative to the housing (Whitfield [0120]), therefore allowing the device to be safely handled by the user prior to beginning a procedure. Providing a detachable first jaw provides the additional benefit of improved ease of assembly or disassembly for sterilization.
Regarding claims 12-14, Gold et al. discloses a clamp head (604, FIG 6, paragraph [0028], including the clamp and drive elements of FIG 2, paragraph [0023]) for forceps (for use with the forceps of FIG 6), comprising: a housing (See annotated FIG 2 above); a stationary jaw (Right arm as viewed in FIG 6, or 204, FIG 2) affixed to said housing (FIG 2 shows a proximal portion of the arm is affixed to the housing); an articulating jaw (Left arm as viewed in FIG 6, or 206, FIG 2) connected to said housing (FIG 2 shows a proximal portion of the arm extends distally from the housing) with a hinged connection (Via pin 220); a shaft (212) that extends into said housing (FIG 2 shows via dashed lines that 212 extends into the housing and forms worm 200, [0023]) and moves said articulating jaw about said hinged connection as saif shaft is rotated within said housing (Paragraphs [0023 and 0028]).
Gold et al. is silent regarding a retention clip that maintains said hinged connection, wherein said articulating jaw is detachable from said housing when said retention clip is removed, wherein said articulating jaw has hinge pins extending therefrom that are received by said housing, wherein said retention clip engages said hinge pins, and wherein at least one tab extends from said retention clip to provide an accessible point for engaging said retention clip with a secondary surgical instrument.
However, Whitfield et al. teaches a clamping system (FIG 45-46) having a clamp head (100, [0066], FIGs 3-4. [0110] discloses that 300 is substantially similar to 100, with the difference being the location of the shipping lock. Therefore, the components of the jaws and housing member are understood to be the same as what is disclosed in relation to 100) having an articulating jaw (116, including 164, FIG 5) selectively detachable from a housing (Wherein the proximal base of 150 forms the housing, and 164 is pivotably secured thereto by screws 168, [0080] and is therefore selectively detachable because the screws can be removed) and held attached to said housing with a removable retention clip (400, FIGs 45, 46, and 50, [0120-0124]. The hinge pins are shown but not numbered in FIG 43-44. Lock 400 covered the pins as shown in FIG 45-46, therefore the first jaw is held attached to the housing because the jaw could not be removed when 400 is covering the hinge pins), wherein said articulating jaw has hinge pins (168) extending therefrom that are received by said housing (Openings 151a, [0080]), wherein said removable retention clip engages said hinge pins (By covering the pins, FIG 45-46), and wherein at least one tab (404) extends from said retention clip (FIG 46) to provide an accessible point for engaging said retention clip with a secondary surgical instrument ([0121-0122] discloses 404 is configured to grasped by a user but is also at least sized and shaped to be configured to engage with a secondary surgical instrument).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the clamping head of Gold et al. such that the articulating jaw is selectively detachable from the housing via hinge pins and to comprise a removable retention clip (i.e. a shipping lock), as taught by Whitfield, for the purpose of supplying the clamping system with a mechanism for preventing premature articulation of the jaws relative to the housing (Whitfield [0120]), therefore allowing the device to be safely handled by the user prior to beginning a procedure. Providing a detachable articulating jaw provides the additional benefit of improved ease of assembly or disassembly for sterilization.
Regarding claims 15-16, Gold et al./Whitfield discloses the invention substantially as claimed, as set forth above for claim 12. Gold further discloses said articulating jaw includes a pinion gear (202, including teeth 216) that rotates about a pivot pin (220, Paragraph [0023]) and wherein said clamp head includes a worm gear (200, including gear teeth 218, FIG 2) that is rotated by said drive shaft (Paragraph [0023]), wherein said worm gear turns said pinion gear and moves said articulating jaw (Paragraph [0023 and 0028]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771