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 .
Response to Preliminary Amendment
The preliminary amendment filed 11/21/2025 has been entered. Claims 20-40 are pending in the application.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the term/phrase “second latch” in claims 35 and 38 is not found in the specification. Presumably, the second latch is - - jaw (246) - -? Since the claimed invention is directed to figs. 20-21 which also refer to figs. 6-7; Examiner is interpreting the second latch as referring to jaw (246).
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.
Claim 40 is 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.
Claim 40 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: Claim 40 depends on cancelled claim 19 making claim 40 incomplete and indefinite. Since claim 40 is a method claim presumably claim 40 depends on method claim 39?
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 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.
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.
Claim(s) 20-23 and 33-40 is/are rejected under 35 U.S.C. 103 as obvious over Bedi et al. (US 20110087276 A1) in view of Agarwal et al. (US 20140353357 A1) and further in view of Patankar et al. (US 20160262756 A1).
Regarding claim 20, Bedi et al. discloses a surgical instrument (100/100’, figs. 1-10, 17, and 37-42), comprising:(a) a first elongate body (104) having a distal portion that supports a first operative surface (158); (b) a second elongate body (102) configured to releasably couple with the first elongate body and having a distal portion that supports a second operative surface (132) configured to cooperate with the first operative surface to clamp and fasten tissue with a plurality of surgical fasteners (400, figs. 49-58);
(c) a protrusion (131/393) disposed at a proximal end of the first elongate body; and
(d) a latch (180/380/398b) disposed at a proximal end of the second elongate body (102) and configured to releasably capture the protrusion (figs. 6-7, 37 and 40), wherein the latch is selectively actuatable relative to the second elongate body to eject the protrusion (“398b which can be positioned against another and/or opposite side of bearing 393 such that an opening force can be applied to the bearing 393 via latch arm 388. As the latching mechanism 380 is moved into its open position, the bearing 393 can move out of slot 397” [0125], figs. 6-7 and 37-40), and thereby promote separation of the first and second elongate bodies ([0081-0089, 0123-0126], figs. 39-41).
Bedi et al. also teaches the first and second elongate bodies are pivotable relative to one another about protrusion (111) when latch (180) is open and captures protrusion (131/393, [0084-0090], figs. 4-7 and 32) and teaches having a cam (183) on the latch (180/380) that moves/ejects a protrusion/pin lock 228 out of a lock slot 229 [0093-0094], figs. 2, 4-7 and 15-16).
Bedi et al. states: “cam 183, for example, can be configured to contact cam surface 223' and, owing to the contoured, beveled, and/or angled surface of cam surface 223', cam 183 can be configured to drive lock 222' distally [0094] …398b which can be positioned against another and/or opposite side of bearing 393 such that an opening force can be applied to the bearing 393 via latch arm 388. As the latching mechanism 380 is moved into its open position, the bearing 393 can move out of slot 397” [0125]
Bedi et al. fails to disclose the first and second elongate bodies are pivotable relative to one another about the protrusion (131/393) when captured by the latch.
Patankar et al. teaches having first and second elongate bodies (12/14) configured to pivot relative to one another about a proximal protrusion (184/186) that snap fits into a slot (188 [0093-0094], figs. 1-3 and 20-30) also teaches having a latch member (206) is selectively actuatable to release a clamp member (16) wherein the latch member (206) is pivotably coupled (pivots via living hinge 213 [0099]) to a proximal end of the clamp lever, wherein the latch member is configured to releasably capture a proximal end feature (214/214a), wherein the latch member is selectively actuatable to eject (214/214a) from the clamp ([0074-0099], figs. 1-33).
Agarwal et al. teaches a similar stapler (10) having first and second elongate bodies (100/200) that are configured to pivot relative to one another about a protrusion (121) and actuating a latch (556) to eject the protrusion (121) and thereby promote separation of the proximal ends of the first and second instrument halves ([0053-0085], figs. 1-9).
Given the teachings of Bedi et al. to have the first and second elongate bodies are pivotable relative to one another about a protrusion and actuating latches to eject protrusions to promote separation of the proximal ends of the first and second elongate bodies, it 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 to modify the protrusion that the first and second instrument halves are configured to pivot about with a latch that actuates to eject the protrusion and thereby promote separation of the proximal ends of the first and second instrument halves to have a ergonomic button/latch to move the protrusion from a clamping slot, more secure pivot connection, and/or for keeping the stapler together while removing different parts such as the cartridge purposes as taught by Patankar et al. and Agarwal et al.
Regarding claims 37, Bedi et al. discloses a surgical instrument (100/100’, figs. 1-10, 17, and 37-42), comprising:(a) a first instrument half (104) having a distal portion that presents a first operative surface (158); (b) a second instrument half (102) configured to releasably couple with the first instrument half and having a distal portion that presents a second operative surface (132) configured to cooperate with the first operative surface to clamp and fasten tissue with a plurality of surgical fasteners (400, figs. 49-58);
(c) a clamp (184/380) operably coupled with one of the first or second instrument halves (102) and movable from a disengaged state to an engaged state to releasably capture a portion (331) of the other of the first or second instrument halves and thereby approximate the first and second operative surfaces (figs. 6-7 and 37-40);
(c) a protrusion (131/393) disposed at a proximal end of the first instrument half; and
(d) a latch (388/398b) disposed at a proximal end of the second instrument half and configured to releasably capture the protrusion (393) and when the clamp (184/380) is in the disengaged state, wherein the latch is selectively actuatable relative to a body portion of the second instrument half to eject the protrusion (398b pushes 393 out of slot 397 [0125], figs. 6-7 and 37-40) and thereby promote separation of the first and second instrument halves when the clamp is in the disengaged state ([0081-0089, 0123-0126], figs. 39-41).
Bedi et al. also teaches the first and second elongate bodies are pivotable relative to one another about protrusion (111) when latch (180) is open and captures protrusion (131/393, [0084-0090], figs. 4-7 and 32) and teaches having a cam (183) on the latch (180/380) that moves/ejects a protrusion/pin lock 228 out of a lock slot 229 [0093-0094], figs. 2, 4-7 and 15-16).
Bedi et al. states: “cam 183, for example, can be configured to contact cam surface 223' and, owing to the contoured, beveled, and/or angled surface of cam surface 223', cam 183 can be configured to drive lock 222' distally [0094] …398b which can be positioned against another and/or opposite side of bearing 393 such that an opening force can be applied to the bearing 393 via latch arm 388. As the latching mechanism 380 is moved into its open position, the bearing 393 can move out of slot 397” [0125]
Bedi et al. fails to disclose the first and second instrument halves are pivotable relative to one another about the protrusion (393) when captured by the latch.
Patankar et al. teaches having first and second instrument halves (12/14) configured to pivot relative to one another about a proximal protrusion (184/186) that snap fits into a slot (188 [0093-0094], figs. 1-3 and 20-30) also teaches having a latch member (206) is selectively actuatable to release a clamp member (16) wherein the latch member (206) is pivotably coupled (pivots via living hinge 213 [0099]) to a proximal end of the clamp lever, wherein the latch member is configured to releasably capture a proximal end feature (214/214a), wherein the latch member is selectively actuatable to eject (214/214a) from the clamp ([0074-0099], figs. 1-33).
Agarwal et al. teaches a similar stapler (10) having first and second instrument halves (100/200) that are configured to pivot relative to one another about a protrusion (121) and actuating a latch (556) to eject the protrusion (121) and thereby promote separation of the proximal ends of the first and second instrument halves ([0053-0085], figs. 1-9).
Given the teachings of Bedi et al. to have the first and second instrument halves pivotable relative to one another about a protrusion and actuating latches to eject protrusions to promote separation of the proximal ends of the first and second instrument halves, it 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 to modify the protrusion that the first and second instrument halves are configured to pivot about with a latch that actuates to eject the protrusion and thereby promote separation of the proximal ends of the first and second instrument halves to have a ergonomic button/latch to move the protrusion from a clamping slot, more secure pivot connection, and/or for keeping the stapler together while removing different parts such as the cartridge purposes as taught by Patankar et al. and Agarwal et al.
Regarding claims 39-40, Bedi et al. discloses a method of operating a surgical instrument (100/100’, figs. 1-10, 17, and 37-42) having a first instrument half (104) and a second instrument half (102) configured to releasably couple together and cooperate to clamp and fasten tissue with a plurality of surgical fasteners (400, figs. 49-58), the method comprising:
aligning a protrusion (131/393 and/or 111) located at a proximal end of the first instrument half with a latch (180/380) located at a proximal end of the second instrument half; capturing the protrusion (393) with the latch and thereby coupling together the proximal ends of the first and second instrument halves and actuating the latch (180/380/398b) to eject the protrusion (398b pushes 393 out of slot 397 [0125], figs. 6-7 and 37-40) and thereby promote separation of the proximal ends of the first and second instrument halves (latch and protrusion “promote separation”) wherein actuating the latch (180/380/398b) to eject the protrusion (393) includes cammingly engaging the protrusion with a cam surface (curved sidewall 398b, fig. 40) of the latch ([0081-0089, 0123-0126], figs. 39-41).
Bedi et al. also teaches the first and second elongate bodies are pivotable relative to one another about protrusion (111) when latch (180) is open and captures protrusion (131/393, [0084-0090], figs. 4-7 and 32) and teaches having a cam (183) on the latch (180/380) that moves/ejects a protrusion/pin lock 228 out of a lock slot 229 [0093-0094], figs. 2, 4-7 and 15-16).
Bedi et al. states: “cam 183, for example, can be configured to contact cam surface 223' and, owing to the contoured, beveled, and/or angled surface of cam surface 223', cam 183 can be configured to drive lock 222' distally [0094] …398b which can be positioned against another and/or opposite side of bearing 393 such that an opening force can be applied to the bearing 393 via latch arm 388. As the latching mechanism 380 is moved into its open position, the bearing 393 can move out of slot 397” [0125]
Bedi et al. fails to disclose the first and second instrument halves are configured to pivot relative to one another about the protrusion and actuating the latch to eject the protrusion and thereby promote separation of the proximal ends of the first and second instrument halves.
Patankar et al. teaches having first and second instrument halves (12/14) configured to pivot relative to one another about a proximal protrusion (184/186) that snap fits into a slot (188 [0093-0094], figs. 1-3 and 20-30) also teaches having a latch member (206) is selectively actuatable to release a clamp member (16) wherein the latch member (206) is pivotably coupled (pivots via living hinge 213 [0099]) to a proximal end of the clamp lever, wherein the latch member is configured to releasably capture a proximal end feature (214/214a), wherein the latch member is selectively actuatable to eject (214/214a) from the clamp ([0074-0099], figs. 1-33).
Agarwal et al. teaches a similar stapler (10) having first and second instrument halves (100/200) that are configured to pivot relative to one another about a protrusion (121) and actuating a latch (556) to eject the protrusion (121) and thereby promote separation of the proximal ends of the first and second instrument halves ([0053-0085], figs. 1-9).
Given the teachings of Bedi et al. to have the first and second instrument halves pivotable relative to one another about a protrusion and actuating latches to eject protrusions to promote separation of the proximal ends of the first and second instrument halves, it 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 to modify the protrusion that the first and second instrument halves are configured to pivot about with a latch that actuates to eject the protrusion and thereby promote separation of the proximal ends of the first and second instrument halves to have an ergonomic button/latch to move the protrusion from a clamping slot, more secure pivot connection, and/or for keeping the stapler together while removing different parts such as the cartridge purposes as taught by Patankar et al. and Agarwal et al.
Regarding claims 21-23, Bedi et al. teaches the protrusion (131/393) has a longitudinal axis that extends transversely to a longitudinal axis of the first elongate body, wherein the protrusion is fixed along the longitudinal axis of the first elongate body, wherein the protrusion comprises a pin (131/393), wherein the latch (180/380) includes a user- engageable portion (latch cover 186) that is accessible on an exterior of the surgical instrument ([0081-0089, 0123-0126], figs. 39-41).
Regarding claim 33, Bedi et al. teaches a first instrument half that includes the first elongate body (104) and a second instrument half that includes the second elongate body (102), wherein one of the first or second instrument halves includes a clamp (184/380) that is selectively actuatable by a user to capture a portion of the other of the first or second instrument halves and thereby approximate the first and second operative surfaces ([0081-0089, 0123-0126], figs. 39-41).
Regarding claim 34, Bedi et al. teaches the latch (380/398b) is configured to eject the protrusion (393, fig. 40) only when the clamp is disengaged from the other of the first or second instrument halves ([0081-0089, 0123-0126], figs. 39-41).
Regarding claims 35 and 38, Bedi et al. teaches the latch comprises a first latch (380/398b), wherein the clamp comprises a lever (380) movable relative to the first elongate body between open and closed positions and having a second latch (398a/388, fig. 40) configured to releasably retain the lever and/or clamp in the closed position ([0125], fig. 40).
Regarding claim 36, Bedi et al. teaches a replaceable staple cartridge (152) having a plurality of surgical staples (400), wherein the replaceable staple cartridge defines one of the first or second operative surfaces ([0081-0083, 0091, 0102, 0126], figs. 2, 8-14 and 37).
Allowable Subject Matter
Claims 24-32 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.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Reasons for Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance: the prior art of record fails to teach or render obvious a surgical stapling device comprising all the structural and functional limitations and further comprising, amongst other limitations/features, a latch member that advances and retracts a protrusion and secures the protrusion in proximal pivot to secure stapling jaws/instrument halves assembled together and the latch is actuatable in a direction parallel to a longitudinal axis of the surgical instrument between a first longitudinal position in which the latch is configured to accept or eject the protrusion and a second longitudinal position in which the latch is configured to capture the protrusion. Though Bedi et al. (US 20110087276 A1) teaches a latch member that advances and retracts a protrusion, Bedi et al.’s latch is not actuatable in a direction parallel to a longitudinal axis of the surgical instrument between a first longitudinal position in which the latch is configured to accept or eject the protrusion and a second longitudinal position in which the latch is configured to capture the protrusion and one of ordinary skill would recognize that a second cable cannot be added to single roller without having to add other rollers and modify the clamping member to function with a two cable system. Having the efficiency and ergonomically easily accessible latch that is actuatable in a direction parallel to a longitudinal axis of the surgical instrument between a first longitudinal position in which the latch is configured to accept or eject a pivoting protrusion and a second longitudinal position in which the latch is configured to capture the protrusion provides a quick connect/disconnect of a surgical instrument.
While various features of the claimed subject matter are found individually in the prior art, a skilled artisan would have to include knowledge gleaned only from the applicant's disclosure to combine or modify the teachings of the prior art to produce the claimed subject matter, and thus obviousness would not be proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). There is no teaching, suggestion, or motivation found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art to combine or modify the teachings of the prior art to produce the claimed invention, and thus obviousness would not be proper. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Additional prior art considered pertinent: see form 892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT LONG whose telephone number is (571)270-3864. The examiner can normally be reached M-F, 9am-5pm, 8-9pm (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SHELLEY SELF can be reached at (571) 272-4524. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT F LONG/Primary Examiner, Art Unit 3731
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