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 Amendment
The amendment filed 10/08/2025 has been entered. Claims 16, 18-30, 33, and 35-39 are pending in the application.
Claim Objections
Claims 16 and 36 are objected to because of the following informalities: In claim 16, the phrase “a compatible stable cartridge” is in error since “stable” is not found in the specification and presumably should be recited - - a compatible staple cartridge - -. Also, claim 36 recites “staple” rather than “stable”. Appropriate correction is required.
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 “compatible stable cartridge” is not found in the specification. See claim objection above/supra
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 16, 22-30, and 35-36 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.
The terms/phrases “compatible stable cartridge” and “ready-to-fire staple cartridge” in claims 16 and 36 respectively is/are relative terms/phrases which renders the claims indefinite. The term “compatible stable cartridge and ready-to-fire staple cartridge” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Both terms “compatible” and “ready” are subjective and arbitrary absent any particular/specific structural recitation. The functions/results “compatible” and “ready” lack the structural members/mechanisms that achieve the functions/results “compatible” and “ready” in the functions are indefinite to how to determine what is “compatible” and “ready”. Also, claim 16 recites “stable cartridge” – see claim objection above.
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.
(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) 16, 22, 26-28, 30, and 35-36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton, IV et al. (US 20190298350 A1)
Regarding claims 16 and 36, Shelton, IV et al. discloses a surgical stapling system (13000), comprising: a shaft (13100); an end effector (13200) coupled to a distal end of the shaft, the end effector comprising: an elongate channel (13210); an anvil (13300); a firing actuator/closure actuator (14820) movable from an unfired position toward a fired position during a firing stroke, wherein the firing actuator is configured to deploy staples from a staple cartridge positioned in the end effector based on the firing actuator moving toward the fired position and has a knife (13824), and
a pivot (rivet 13401/ rivet 14401, at end cap 13400, figs. 65-80) pivotably coupling the anvil to the elongate channel about a first pivot axis, wherein the anvil is pivotable relative to the elongate channel between an open position and a closed position;
a closure actuator (13820/14820) movable from a first position toward a second position during a closure stroke, wherein the closure actuator is configured to move the anvil toward the closed position; and
a closure lockout (pivot arms 13540/pivoting closure link assembly 13530 pivotally attached to end portion 14314) pivotable about a second pivot axis between: a locked state in which the closure lockout engages the closure actuator at a location proximal with respect to the pivot to prevent the closure actuator from moving the anvil toward the closed position; and an unlocked state in which the closure actuator is permitted to move the anvil toward the closed position, wherein the second pivot axis is proximal to the first pivot axis ([0702-0720], figs. 65-80); and
a firing/closure lockout (14840/14850), configurable between: a second locked state in which the firing actuator is prevented from moving toward the fired position; and a second unlocked state in which the firing actuator (14820) is permitted to move toward the fired position (and anvil 13900 lockout [0712-0715]) wherein installation of a compatible stable cartridge/ready-to-fire staple cartridge in the elongate channel is configured to pivot the lockout to the unlocked state (functional/intended use of “a compatible stable cartridge” – is this compatible stable cartridge the same prior recited staple cartridge?). Shelton, IV et al. also having “other pivot arrangements” [0706].
Regarding claim 22, Shelton, IV et al. discloses the closure actuator (13820/14820) comprises: an elongate bar (firing drive shaft 13810 and/or 13540) extending along a first axis; and a flange (13826/13828) extending distally from the elongate bar along a second axis transverse to the first axis (channel engagement tabs 13826 & anvil engagement tabs 13828 also 13540 has flange portion shown attached to closure shuttle 13520, [0702-0720], figs. 65-80), wherein the first position of the closure actuator comprises a distal position, and wherein the second position of the closure actuator comprises a proximal position and further comprising an unlocking bar (lock tab 13918 and/or firing drive shaft 13810 rotates to axially move closure shuttle 13520 and/or anvil lockout assembly 13900) rotatable between a first position and a second position, wherein the unlocking bar (lock tab 13918/anvil 13900 lockout [0712-0715]) is configured to engage the anvil to transition the closure lockout toward the unlocked state based on the unlocking bar rotating toward the second position (via shuttle 13520 and link/bar 13540 have a converse relationship of proximal and distal position in which the second proximal position is the shuttle [0702-0720], figs. 65-80).
Regarding claim 35, Shelton, IV et al. discloses a staple cartridge comprising a key (cartridge body 13702/key member 13760/fin 13762), wherein the key is configured to move the unlocking bar toward the second position to transition/engage the closure lockout toward to place the unlocked state and a second key (14840) configured to engage the firing lockout to place the firing lockout into the second unlocked state (13900 [0721-0730], figs 75-80).
Regarding claims 26-27, Shelton, IV et al. discloses: a firing actuator/closure actuator (14820) movable from an unfired position toward a fired position during a firing stroke, wherein the firing actuator is configured to deploy staples from a staple cartridge positioned in the end effector based on the firing actuator moving toward the fired position; and a firing lockout (14840/14850), configurable between: a firing lockout state in which the firing actuator is prevented from moving through the firing stroke; and a firing unlocked state in which the firing actuator is permitted to move through the firing stroke, wherein the closure actuator is further movable from the second position to a third position during a firing stroke, wherein closure actuator is configured to deploy staples from a staple cartridge positioned in the end effector based on the closure actuator moving from the second position toward the third position ([0722-0730], figs. 75-80 Also, Note – applicants speciation recites “the firing actuator can be considered both a closure actuator and/or a firing actuator” [0034, 0039]).
Regarding claim 30, Shelton, IV et al. discloses the closure actuator (13820/14820) comprises a hook (14848 figs. 76-77), wherein the closure lockout (14840/14850) comprises a first tab (148/146 and/or 14842/backstop wall 14827), and wherein: in the locked state of the closure lockout, the first tab (148/146) is longitudinally aligned with the hook to prevent the closure actuator from moving through the closure stroke; and in the unlocked state of the closure lockout, the first tab (148/146) is displaced from the hook to allow the closure actuator to move through the closure stroke wherein the closure actuator (13820/14820) defines an aperture (fig. 75), and wherein: in the locked state, the tab is received in the aperture to prevent the closure actuator from moving the anvil toward the closed position; and in the unlocked state, the tab is displaced from the aperture to allow the closure actuator to move the anvil toward the closed position ([0722-0730], figs. 75-80).
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.
Claim(s) 23-25 is/are rejected under 35 U.S.C. 103 as obvious over Shelton, IV et al. (US 20190298350 A1) in view of Williams et al. (US 20140263569 A1).
Regarding claims 23-25, Shelton, IV et al. discloses, an unlocking bar (firing drive shaft 13810 rotates to axially move closure shuttle 13520 and/or anvil lockout assembly 13900), moveable between a first position and a second position, wherein the unlocking bar is configured to engage the anvil to transition the closure lockout toward the unlocked state based on the unlocking bar rotating toward the second position (via shuttle 13520 [0702-0720], figs. 65-80) wherein the unlocking bar is biased (lock spring 13920) toward the first position, a staple cartridge comprising a key (cartridge body 13702/key member 13760/fin 13762), wherein the key is configured to move the unlocking bar toward the second position to transition/engage the closure lockout toward to place the unlocked state and a second key configured to engage the firing lockout to place the firing lockout into the second unlocked state (13900 [0712-0715]).
Shelton, IV et al. fails to disclose the unlocking bar is rotatable between a first position and a second position to lock/unlock.
Williams et al. teaches having unlocking bar (432/840 and locking lever 1030) that is rotatable between a first position and a second position to lock/unlock ([0292-0309], figs. 109-137) and teaches having a locking member (132) that pivots upwardly via member (126 [0199], figs. 8-9).
Given the teachings of Shelton, IV et al. to have an unlocking bar moveable between a first position and a second position, wherein the unlocking bar is configured to engage the anvil to transition the closure lockout toward the unlocked state based on the unlocking bar rotating toward the second position, 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 unlocking bar to be moveable via being rotatable between a first position and a second position to lock/unlock for easier and more effective pivoting engagement, leverage purposes, and/or for spacing purposes as taught by Williams et al.
Allowable Subject Matter
Claims 18-21, 33, and 37-39 are allowed.
Claims 29 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.
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 Potential 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 instrument that has a firing lockout and a closure lockout comprising all the structural and functional limitations and further comprising, amongst other limitations/features, a closure actuator, firing actuator; firing lockout and a closure lockout move from a locked state to an unlocked state wherein the closure actuator comprises a hook, wherein the closure lockout comprises a first tab, and wherein: in the locked state of the closure lockout, the first tab is longitudinally aligned with the hook to prevent the closure actuator from moving through the closure stroke; and in the unlocked state of the closure lockout, the first tab is displaced from the hook to allow the closure actuator to move through the closure stroke, wherein said closure lockout further comprises: a flange; a first lockout a first lockout arm pivotably coupled to said flange about said second pivot axis, wherein said first tab extends transversely from said first lockout arm; and a second lockout a second lockout arm pivotable coupled to said flange about said second pivot axis, wherein a second tab extends from transversely from said second lockout arm toward said first lockout arm; wherein: in said locked state of said closure lockout, said first tab and said second tab longitudinally aligned with said hook to prevent said closure actuator from moving through said closure stroke; and in said unlocked state of said closure lockout, said first tab and said second tab are displaced from said hook to allow said closure actuator to move through said closure stroke. Though by Shelton, IV et al. (US 20210290233 A1) and Jasemian et al. (US 20170290584 A1) teaches having a firing lockout and a closure lockout; Shelton, IV et al. fails to teach having a flange with a first lockout a first lockout arm pivotably coupled to said flange about said second pivot axis, wherein said first tab extends transversely from said first lockout arm; and a second lockout a second lockout arm pivotable coupled to said flange about said second pivot axis, wherein a second tab extends from transversely from said second lockout arm toward said first lockout arm; wherein: in said locked state of said closure lockout, said first tab and said second tab longitudinally aligned with said hook to prevent said closure actuator from moving through said closure stroke; and in said unlocked state of said closure lockout, said first tab and said second tab are displaced from said hook to allow said closure actuator to move through said closure stroke and one of ordinary skill would recognize that a flange with pivotal arms locking/mating tabs with a hook would not be possible without having to add a flange to the lockout, pivotal arms and other structural features to modify the clamping/jaw members to function with a two arm flange lockout system. Having the efficiency and secure locking of the added pivotal arms provides an effective clamping, locking/unlocking and safe compressive clamping of for healing/suturing the closure of a surgical area.
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.”
Response to Arguments
Applicant’s arguments with respect to claim(s) 16, 18-30, 33, and 35-39 have been considered but are moot because the new ground of rejection does not rely on new 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph issues applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The Double Patenting Rejection has been withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 20250120714 A1- “lockout 100340 is pivotably coupled …be pivotably coupled at any suitable location in the stapling instrument” [0110] & see references cited, form 892.
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 ROBERT LONG whose telephone number is (571)270-3864. The examiner can normally be reached M-F, 9am-5pm, 8-9pm (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Truong Truong can be reached at (571) 272-4472. 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