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 .
Information Disclosure Statement
Receipt is acknowledged of an Information Disclosure Statement (IDS), filed 18 June 2026, which has been placed of record in the file. An initialed, signed, and dated copy of each PTO-1449 or PTO-SB-08 form is attached to the Office action.
Response to Preliminary Amendment
Receipt is acknowledged of a preliminary amendment, filed 13 April 2026, which has been placed of record and entered in the file.
Status of the claims:
Claims 21-40 are pending.
Claims 21-40 are new.
Claims 1-20 are canceled.
Specification and Drawings:
Amendments to the specification have been submitted in the amendment filed 13 April 2026.
Amendments to the drawings have not been submitted in the amendment filed 13 April 2026.
Claim Objections
Claim 24 is objected to because of the following informalities:
Claim 24 is objected to as depending from itself. For examination purposes, claim 24 is considered to depend from claim 23.
Appropriate correction is required.
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)(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.
Claims 21-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bittner et al. (US Patent No. 5,878,938).
With respect to claim 21, Bittner et al. disclose a surgical fastening instrument (surgical stapler 20), comprising: (a) a first elongate instrument portion having a first proximal body and a first distal jaw configured to receive a cartridge having a plurality of surgical fasteners (lower frame piece 50 having a body and a jaw 53 configured to receive a cartridge 60, fig. 1); (b) a second elongate instrument portion having a second proximal body and a second distal jaw configured to form the surgical fasteners (upper frame piece 30 having a jaw 32 defining an anvil, fig. 1), the first and second elongate instrument portions configured to releasably couple together to clamp and surgically fasten tissue positioned between the first and second distal jaws while the first and second proximal bodies are gripped by a user (fig. 1); (c) a surgical fastener actuator advanceable distally relative to the first and second elongate instrument portions to fire the surgical fasteners into the clamped tissue, an underside of the surgical fastener actuator including a recess (firing assembly 40 including knife blade 44, underside 44a of knife blade 44 includes a spring notch 44b, fig. 4); and (d) a lockout spring (biasing leaf spring 57, fig. 3), wherein when an unspent cartridge is absent from the first distal jaw, the lockout spring is configured to bias the surgical fastener actuator into a lockout state and thereby inhibit distal actuation thereof (biasing leaf spring 57 urges knife blade 44 upwardly into the first locked position, fig. 4, col. 6, l. 60 - col. 7, l. 2), wherein when an unspent cartridge is seated within the first distal jaw, the surgical fastener actuator is configured to assume a firing state in which the surgical fastener actuator is advanceable distally relative to the lockout spring in a resiliently deflected position such that a portion of the lockout spring is received within the recess (movement of the knife blade 44 from the locked position to the unlocked position is effected by disposition of an unused staple cartridge 60, fig. 6, col. 7, l. 28-39). As shown in figs. 5 and 6, when the knife blade 44 is in the unlocked position, the leaf spring 57 is received in the notch 44b.
With respect to claim 22, Bittner et al. disclose the lockout spring is longitudinally fixed relative to the first and second elongate instrument portions such that the surgical fastener actuator is longitudinally advanceable relative to the lockout spring (the spring 57 is longitudinally fixed to the lower frame piece 50, fig. 2).
With respect to claim 23, Bittner et al. disclose the lockout spring comprises a leaf spring (biasing leaf spring 57) having a distal base (anchor portion 57b, 57c, fig. 3) and a proximal leg extending angularly relative to the distal base (finger 57a), the proximal leg being deflectable relative to the distal base by the surgical fastener actuator (movement of the knife blade 44 from the locked position to the unlocked position is effected by disposition of an unused staple cartridge 60, member 66 engages surface 47 of knife blade 44, fig. 6, col. 7, l. 28-39) so that the proximal leg is received within the recess upon distal advancement of the surgical fastener actuator (the notch 44b includes an inclined surface 44c extending proximally, and therefore the spring 57 is received in the notch 44b, 44c while the knife blade 44 is guided distally over the spring 57, fig. 4, col. 6, l. 60 - col. 7, l. 2).
With respect to claim 24, Bittner et al. disclose the distal base is configured to assume a deflected state when the proximal leg is deflected by the surgical fastener actuator (anchor portion 57b extends from finger 57a and deflects when finger 57a deflects, figs. 10a-d).
With respect to claim 25, Bittner et al. disclose the recess includes an open distal end (open end at stop surface 44d, fig. 4) configured to receive a proximal end of the lockout spring when the surgical fastener actuator is advanced distally in the firing state (the notch 44b includes an inclined surface 44c extending proximally, and therefore the spring 57 is received in the notch 44b, 44c while the knife blade 44 is guided distally over the spring 57, fig. 4, col. 6, l. 60 - col. 7, l. 2).
With respect to claim 26, Bittner et al. disclose the surgical fastener actuator includes a block (roof member 70, fig. 1) and at least one beam extending distally from the block (firing beams extending from the roof member 70, fig. 1), the recess being disposed in the block (notch 44b is disposed in the roof member 70 when the notch 44b passes through the roof member, figs. 1, 2).
With respect to claim 27, Bittner et al. disclose the recess is disposed in an underside of the block (underside 44a of knife blade 44 includes a spring notch 44b, notch 44b is disposed in underside of the roof member 70 when knife blade passes through the roof member, figs. 2, 4).
With respect to claim 28, Bittner et al. disclose the at least one beam includes a knife configured to cut the clamped tissue as the surgical fastener actuator advances distally (knife blade 44 including cutting surface 45, fig. 1).
With respect to claim 29, Bittner et al. disclose the first elongate instrument portion (lower frame 50) includes a floor having an opening (spacer 41 with aperture 41c, fig. 3) with which the recess is configured to align when the surgical fastener actuator is actuated distally such that the lockout spring is received into the recess and the opening simultaneously (end tab 57c is received in aperture 41c and finger 57a is received in notch 44b simultaneously, fig. 3).
With respect to claim 30, Bittner et al. disclose a guide secured to the first instrument portion and configured to guide distal advancement of the surgical fastener actuator (roof member 70 guides advancement of knife blade 44, fig. 1).
With respect to claim 31, Bittner et al. disclose the lockout spring is secured to the guide (spring 57 is secured to roof member 70 via the spacer 41, fig. 2).
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 32-40 are rejected under 35 U.S.C. 103 as being unpatentable over Bittner et al. (US Patent No. 5,878,938).
With respect to claim 32, Bittner et al. disclose a method of operating a surgical fastening instrument (surgical stapler 20, fig. 1) having first and second jaws (jaw 53, jaw 32), a surgical fastener actuator (firing assembly 40 including knife blade 44, underside 44a of knife blade 44 includes a spring notch 44b, fig. 4), and a lockout spring (biasing leaf spring 57, fig. 3), the method comprising: receiving an unspent cartridge with the first jaw (unspent cartridge 60 is received in jaw 53), the unspent cartridge having a plurality of surgical fasteners (staple cartridge 60 includes staples, fig. 1); with the unspent cartridge, deflecting the lockout spring to thereby transition the surgical fastener actuator from a lockout state to a firing state (movement of the knife blade 44 from the locked position to the unlocked position is effected by disposition of an unused staple cartridge 60, fig. 6, col. 7, l. 28-39); approximating the first and second jaws from an open position to a closed position (handle portion 51 for approximating jaws 53, 32, fig. 1); and guiding the surgical fastener actuator in the firing state distally over the lockout spring so that a portion of the lockout spring is received into a recess disposed in an underside of the surgical fastener actuator (when the knife blade 44 is in the unlocked position, the leaf spring 57 is received in the notch 44b, figs. 5, 6), thereby discouraging plastic deformation of the lockout spring. As shown in fig. 4 and described in col. 6, l. 60 - col. 7, l. 2, the notch 44b includes an inclined surface 44c extending proximally, and therefore the spring 57 is received in the notch 44b, 44c while the knife blade 44 is guided distally over the spring 57.
See MPEP 2111.04 I. which states:
However, the court noted that “a whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited”.
See MPEP 2111.04 II. which states:
The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the conditions(s) precedent are not met.
The clause “thereby discouraging plastic deformation of the lockout spring” simply expresses the intended result of the recited step of “guiding the surgical fastener actuator in the firing state distally over the lockout spring so that a portion of the lockout spring is received into a recess disposed in an underside of the surgical fastener actuator”. Therefore, the clause “thereby discouraging plastic deformation of the lockout spring” need not be given weight, in accordance with MPEP 2111.04 I.
Moreover, to the extent that Bittner et al. can be considered not to expressly disclose “thereby discouraging plastic deformation of the lockout spring”, this result is implicit in the disclosure of Bittner et al. at least because Bittner et al. expressly disclose of the step of “guiding the surgical fastener actuator in the firing state distally over the lockout spring so that a portion of the lockout spring is received into a recess disposed in an underside of the surgical fastener actuator”. Thus, one of ordinary skill in the art would reasonably draw the inference that plastic deformation of the lockout spring would be discouraged by the presence of the notch in the knife blade which decreases the degree of bending of the spring.
Accordingly, 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 Bittner et al. method to include thereby discouraging plastic deformation of the lockout spring, since Bittner et al. disclose guiding the surgical fastener actuator in the firing state distally over the lockout spring so that a portion of the lockout spring is received into a recess disposed in an underside of the surgical fastener actuator, and one of ordinary skill in the art would reasonably draw the inference that plastic deformation of the lockout spring would be discouraged. ("[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968)). MPEP 2144.01.
With respect to claim 33, Bittner et al. disclose the lockout spring remains longitudinally fixed as the surgical fastener actuator advances distally (the spring 57 is longitudinally fixed to the lower frame piece 50, fig. 2).
With respect to claim 34, Bittner et al. disclose deflecting the lockout spring with the unspent cartridge includes driving a portion of the surgical fastener actuator against the lockout spring with the unspent cartridge (movement of the knife blade 44 from the locked position to the unlocked position is effected by disposition of an unused staple cartridge 60, member 66 engages surface 47 of knife blade 44, fig. 6, col. 7, l. 28-39).
With respect to claim 35, Bittner et al. disclose the lockout spring comprises a leaf spring (leaf spring 57) having a base (anchor portion 57b) and a leg (spring finger 57a), wherein deflecting the lockout spring includes deflecting the leg relative to the base (figs. 3-6), the leg being received into the recess when the surgical fastener actuator advances distally (spring finger 57a received in notch 44b).
With respect to claim 36, Bittner et al. disclose the surgical fastener actuator includes a block (roof member 70, fig. 1) and at least one beam extending distally from the block (firing beams extending from the roof member 70, fig. 1), the recess being disposed in the block (notch 44b is disposed in the roof member 70 when the notch 44b passes through the roof member, figs. 1, 2).
With respect to claim 37, Bittner et al. disclose the recess is disposed in an underside of the block (underside 44a of knife blade 44 includes a spring notch 44b, notch 44b is disposed in underside of the roof member 70 when knife blade passes through the roof member, figs. 2, 4).
With respect to claim 38, Bittner et al. disclose the at least one beam includes a knife configured to cut a medium clamped between the first and second jaws as the surgical fastener actuator advances distally (knife blade 44 including cutting surface 45, fig. 1).
With respect to claim 39, Bittner et al. disclose a guide that guides longitudinal advancement of the surgical fastener actuator (roof member 70 guides advancement of knife blade 44, fig. 1), the lockout spring being secured to the guide (spring 57 is secured to roof member 70 via the spacer 41, fig. 2).
With respect to claim 40, Bittner et al. disclose the lockout spring (biasing leaf spring 57) includes a distal base (anchor portion 57b, 57c, fig. 3) and a proximal leg (finger 57a), wherein guiding the surgical fastener actuator distally over the lockout spring includes deflecting the proximal leg relative to distal base with the surgical fastener actuator while permitting the distal base to deflect within an interior space of the guide (anchor portion 57b extends from finger 57a and deflects when finger 57a deflects, figs. 10a-d, end tab 57c deflects in aperture 41c, fig. 2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Collins et al. (US Patent Publ. No. 2019/0137349) disclose a firing actuator including a recess on the underside (fig. 56).
Chen (US Patent Publ. No. 2015/0265275) disclose a lockout spring (fig. 3a).
Weng (EP 2,163,209) disclose a firing actuator including a recess on the underside.
Nalagatla et al. (US Patent Publ. No. 2009/0308907) disclose a linear stapler including a lockout.
Bittner et al. (US Patent No. 5,673,842) disclose a linear stapler including a spring lockout.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linda J. Hodge whose telephone number is (571)272-0571. The examiner can normally be reached Monday-Friday 8:00-5:00.
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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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/LINDA J. HODGE/Primary Examiner, Art Unit 3731
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