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 Information Disclosure Statement(s) (IDS), filed 20 December 2024, which have 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 20 December 2024, which has been placed of record and entered in the file.
Status of the claims:
Claims 1-15, 17-19, and 21-22 are pending.
Claims 16 and 20 are canceled.
Specification and Drawings:
Amendments to the specification have been submitted in the amendment filed 20 December 2024.
Amendments to the drawings have not been submitted in the amendment filed 20 December 2024.
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 4-5 and 14-15 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 4-5 and 14-15 are ambiguous as it is not clear to what element “that biasing member” refers. It is recommended that claims 4-5 and 14-15 be amended to change “that” to --said-- or --the--.
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 1-3, 6, and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton et al. (US Patent Publ. No. 2021/0186501).
With respect to claim 1, Shelton et al. disclose a surgical stapling device (fig. 1) comprising: an elongate body having a proximal portion and a distal portion (shaft 1110, fig. 2); a tool assembly supported on the distal portion of the elongate body (end effector 1200, fig. 2), the tool assembly including: an anvil assembly (jaw 1230, fig. 3); and a cartridge assembly coupled to the anvil assembly to facilitate movement of the tool assembly between open and clamped positions (jaw 1220, fig. 3), the cartridge assembly including a channel member (channel 1222, fig. 4) and a staple cartridge (cartridge 1400), the channel member defining a channel (channel 1222, fig. 4), the staple cartridge supported within the channel of the channel member and including a cartridge body, staples, pushers, and an actuation sled assembly (cartridge includes body, staples, pushers, actuation sled assembly, fig. 4, [0591], [0592]), the cartridge body having a tissue engaging surface and defining a knife slot and staple receiving slots positioned on each side of the knife slot, the staples received in the staple receiving slots (cartridge body having tissue engaging surface, knife slot, staple receiving slots, and staples, fig. 4, [0591], [0592]), the actuation sled assembly movable within the cartridge body from a sled retracted position to a sled advanced position to eject the staples from the staple receiving slots of the cartridge body ([0592], [0593]), the actuation sled assembly including an actuation sled (sled 40740, fig. 104), a knife (tissue cutting knife 40750), and a biasing member (pins 40752 and ridges 40425 prevent the knife 40750 from being retracted proximally and are thus considered a biasing member, fig. 112, [0631]), the knife received within the knife slot of the cartridge body and including a cutting edge (knife edge 40751), the knife secured to the actuation sled and movable from a lowered position in which the cutting edge is shielded within the knife slot of the cartridge body (lowered position, fig. 104) to a raised position in which the cutting edge of the knife extends from the knife slot above the tissue engaging surface of the cartridge body (up position, fig. 107), the biasing member secured to the actuation sled and positioned to urge the knife to the lowered position (pins 40752 and ridges 40425 hold the knife 40750 in the lowered position and prevent the knife 40750 from being retracted proximally, fig. 112, [0631]); and a drive assembly (staple firing system 40700) including a working member (firing bar 40720), the working member positioned proximally of the actuation sled assembly and movable into engagement with the knife of the actuation sled assembly to move the knife from the lowered position to the raised position (figs. 104-108).
With respect to claim 2, Shelton et al. disclose the actuation sled includes a central portion that is received in the knife slot of the cartridge body (center portion 40743 of sled 40740 travels in slot 40423, fig. 106, [0630]), the central portion defining a recess that receives the knife (arcuate recess in center portion 40743, annotated Figure 107).
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With respect to claim 3, Shelton et al. disclose the knife includes a base portion having a circular configuration that is rotatably received within the recess in the central portion of the actuation sled (arcuate surface of knife received in arcuate recess in center portion 40743, annotated Figure 107).
With respect to claim 6, Shelton et al. disclose the knife includes a curved proximally facing surface (arcuate cam surface 40754) and the working end of the drive assembly includes a distally facing curved cam surface (arcuate cam recess 40724), the distally facing curved cam surface of the working end of the drive assembly being movable into the curved proximally facing surface of the knife to move the knife from the lowered position to the raised position (figs. 104-108).
With respect to claim 11, Shelton et al. disclose a cartridge assembly comprising: a channel member (channel 1222, fig. 4) and a staple cartridge (cartridge 1400), the channel member defining a channel (channel 1222, fig. 4), the staple cartridge supported within the channel of the channel member and including a cartridge body, staples, pushers, and an actuation sled assembly (cartridge includes body, staples, pushers, actuation sled assembly, fig. 4, [0591], [0592]), the cartridge body having a tissue engaging surface and defining a knife slot and staple receiving slots positioned on each side of the knife slot, the staples received in the staple receiving slots (cartridge body having tissue engaging surface, knife slot, staple receiving slots, and staples, fig. 4, [0591], [0592]), the actuation sled assembly movable within the cartridge body from a sled retracted position to a sled advanced position to eject the staples from the staple receiving slots of the cartridge body ([0592], [0593]), the actuation sled assembly including an actuation sled (sled 40740, fig. 104), a knife (tissue cutting knife 40750), and a biasing member (pins 40752 and ridges 40425 prevent the knife 40750 from being retracted proximally and are thus considered a biasing member, fig. 112, [0631]), the knife received within the knife slot of the cartridge body and including a cutting edge (knife edge 40751), the knife secured to the actuation sled and movable from a lowered position in which the cutting edge is shielded within the knife slot of the cartridge body (lowered position, fig. 104) to a raised position in which the cutting edge of the knife extends from the knife slot above the tissue engaging surface of the cartridge body (up position, fig. 107), the biasing member secured to the actuation sled and positioned to urge the knife to the lowered position (pins 40752 and ridges 40425 hold the knife 40750 in the lowered position and prevent the knife 40750 from being retracted proximally, fig. 112, [0631]); and a drive assembly (staple firing system 40700) including a working member (firing bar 40720), the working member positioned proximally of the actuation sled assembly and movable into engagement with the knife of the actuation sled assembly to move the knife from the lowered position to the raised position (figs. 104-108).
With respect to claim 12, Shelton et al. disclose the actuation sled includes a central portion that is received in the knife slot of the cartridge body (center portion 40743 of sled 40740 travels in slot 40423, fig. 106, [0630]), the central portion defining a recess that receives the knife (arcuate recess in center portion 40743, annotated Figure 107).
With respect to claim 13, Shelton et al. disclose the knife includes a base portion having a circular configuration that is rotatably received within the recess in the central portion of the actuation sled (arcuate surface of knife received in arcuate recess in center portion 40743, annotated Figure 107).
Claims 1-2, 7-12, and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baxter et al. (US Patent Publ. No. 2019/0365384), cited by applicant.
With respect to claim 1, Baxter et al. disclose a surgical stapling device (fig. 1) comprising: an elongate body having a proximal portion and a distal portion (shaft, fig. 1); a tool assembly supported on the distal portion of the elongate body (end effector 40, fig. 1), the tool assembly including: an anvil assembly (anvil 60, fig. 2); and a cartridge assembly coupled to the anvil assembly to facilitate movement of the tool assembly between open and clamped positions (lower jaw 50), the cartridge assembly including a channel member and a staple cartridge (fig. 5), the channel member defining a channel (channel 52), the staple cartridge (cartridge 70) supported within the channel of the channel member and including a cartridge body, staples, pushers, and an actuation sled assembly (cartridge includes body, staples, pushers, sled, fig. 5), the cartridge body having a tissue engaging surface and defining a knife slot and staple receiving slots positioned on each side of the knife slot, the staples received in the staple receiving slots (cartridge body includes tissue engaging surface, knife slot, staple slots, staples, fig. 5), the actuation sled assembly movable within the cartridge body from a sled retracted position to a sled advanced position to eject the staples from the staple receiving slots of the cartridge body (sled movable to eject staples, figs. 7A-7B), the actuation sled assembly including an actuation sled (wedge sled 678, fig. 22), a knife (secondary cutting blade 680, fig. 22), and a biasing member (resilient member 686), the knife received within the knife slot of the cartridge body and including a cutting edge (blade 680 received in knife slot and including cutting edge 691, figs. 23, 24), the knife secured to the actuation sled and movable from a lowered position in which the cutting edge is shielded within the knife slot of the cartridge body (blade 680 includes retaining feature, lowered position, fig. 23) to a raised position in which the cutting edge of the knife extends from the knife slot above the tissue engaging surface of the cartridge body (raised position, figs. 24, 25), the biasing member secured to the actuation sled and positioned to urge the knife to the lowered position (resilient member 686 secured by fixation feature 688 to bias blade 680 toward the retracted position, fig. 23, [0105]); and a drive assembly including a working member (knife member 80 with distal projection 83, fig. 23), the working member positioned proximally of the actuation sled assembly and movable into engagement with the knife of the actuation sled assembly to move the knife from the lowered position to the raised position (figs. 23-24).
With respect to claim 2, Baxter et al. disclose the actuation sled includes a central portion that is received in the knife slot of the cartridge body (central portion 677, fig. 22), the central portion defining a recess that receives the knife (cavity 684, fig. 23).
With respect to claim 7, Baxter et al. disclose the biasing member includes an elastic band. Baxter et al. disclose the resilient member 686 comprises a leaf spring that flexes up and down (i.e. is elastic), and that the resilient member is a flat elongated member (i.e., is a band), and thus is considered to be an elastic band.
With respect to claim 8, Baxter et al. disclose the knife (blade 680) is movable vertically within the recess between the lowered position (fig. 23) and the raised position (fig. 24).
With respect to claim 9, Baxter et al. disclose the elastic band has a first end secured to the knife (retaining feature 694 engages resilient member 686, fig. 24) and a second end secured to the actuation sled (resilient member 686 secured at fixation feature 688, fig. 24).
With respect to claim 10, Baxter et al. disclose the knife has a proximally facing angled surface (proximally facing surface of blade 680, fig. 24) and the working member of the drive assembly includes an angled cam surface (distally facing surface of projection 83, fig. 24), the angled cam surface of the working member of the drive assembly movable into engagement with the proximally facing angled surface of the knife to move the knife from the lowered position to the raised position (figs. 23-24). The surfaces of the blade 680 and the projection 83 form a substantially right angle with the longitudinal axis of the end effector, and are therefore considered to be angled.
With respect to claim 11, Baxter et al. disclose a cartridge assembly comprising: a channel member defining a channel member defining a channel (channel 52), a staple cartridge (cartridge 70) supported within the channel of the channel member and including a cartridge body, staples, pushers, and an actuation sled assembly (cartridge includes body, staples, pushers, sled, fig. 5), the cartridge body having a tissue engaging surface and defining a knife slot and staple receiving slots positioned on each side of the knife slot, the staples received in the staple receiving slots (cartridge body includes tissue engaging surface, knife slot, staple slots, staples, fig. 5), the actuation sled assembly movable within the cartridge body from a sled retracted position to a sled advanced position to eject the staples from the staple receiving slots of the cartridge body (sled movable to eject staples, figs. 7A-7B), the actuation sled assembly including an actuation sled (wedge sled 678, fig. 22), a knife (secondary cutting blade 680, fig. 22), and a biasing member (resilient member 686), the knife received within the knife slot of the cartridge body and including a cutting edge (blade 680 received in knife slot and including cutting edge 691, figs. 23, 24), the knife secured to the actuation sled and movable from a lowered position in which the cutting edge is shielded within the knife slot of the cartridge body (blade 680 includes retaining feature, lowered position, fig. 23) to a raised position in which the cutting edge of the knife extends from the knife slot above the tissue engaging surface of the cartridge body (raised position, figs. 24, 25), the biasing member secured to the actuation sled and positioned to urge the knife to the lowered position (resilient member 686 secured by fixation feature 688 to bias blade 680 toward the retracted position, fig. 23, [0105]); and a drive assembly including a working member (knife member 80 with distal projection 83, fig. 23), the working member positioned proximally of the actuation sled assembly and movable into engagement with the knife of the actuation sled assembly to move the knife from the lowered position to the raised position (figs. 23-24).
With respect to claim 12, Baxter et al. disclose the actuation sled includes a central portion that is received in the knife slot of the cartridge body (central portion 677, fig. 22), the central portion defining a recess that receives the knife (cavity 684, fig. 23).
With respect to claim 17, Baxter et al. disclose the biasing member includes an elastic band. Baxter et al. disclose the resilient member 686 comprises a leaf spring that flexes up and down (i.e. is elastic), and that resilient member is a flat elongated member (i.e., is a band), and thus is considered to be an elastic band.
With respect to claim 18, Baxter et al. disclose the knife (blade 680) is movable vertically within the recess between the lowered position (fig. 23) and the raised position (fig. 24).
With respect to claim 19, Baxter et al. disclose the elastic band has a first end secured to the knife (retaining feature 694 engages resilient member 686, fig. 24) and a second end secured to the actuation sled (resilient member 686 secured at fixation feature 688, fig. 24).
Claims 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scirica et al. (US Patent Publ. No. 2013/0313305).
With respect to claim 21, Scirica et al. disclose a cartridge assembly (fig. 2) comprising: a channel member defining a channel (carrier 62 defining a channel 65, fig. 2); and a staple cartridge (cartridge 100, fig. 2) supported within the channel of the channel member and including a cartridge body, staples, pushers, and an actuation sled assembly (cartridge 100 including body 102, staples 110, pushers 120, sled 130, fig. 2), the cartridge body having a tissue engaging surface and defining a knife slot and staple receiving slots positioned on each side of the knife slot (cartridge body 102 including tissue engaging surface, knife slot 108, staple receiving slots 106, fig. 2) the staples received in the staple receiving slots (fig. 2), the actuation sled assembly movable within the cartridge body from a sled retracted position to a sled advanced position to eject the staples from the staple receiving slots of the cartridge body (sled 130 is urged through cartridge to eject fasteners, [0054]), the actuation sled assembly including an actuation sled (actuation sled 130), a knife (knife member 160), a cover (knife guard 170, fig. 3), and a biasing member (spring 178, fig. 3), the knife secured to the actuation sled and received within the knife slot of the cartridge body (knife member 160 engages sled 130, figs. 5, 6), the knife having a cutting edge (cutting surface 165, fig. 6), the cover pivotally secured to the knife and defining a pocket (knife guard 170 is pivoted via pegs 169 on the knife member 160, knife guard portions 172 define a pocket, fig. 3), the cover movable from a first position in which the cutting edge of the knife is received within the pocket of the cover (figs. 5, 5A) and a second position in which the cutting edge of the knife is exposed (figs. 5D, 6), the biasing member secured to the knife and positioned to urge the cover towards the first position (biasing members 178 bias knife guard 170 towards the storage position, fig. 5, [0058]). Scirica et al. disclose that the knife guard 170 is pivotable about pegs 174, and the knife guard 170 is secured to the knife 160 via the pegs 169 and the tracks 184, and thus the knife guard is considered to be pivotally secured to the knife.
With respect to claim 22, Scirica et al. disclose the biasing member (biasing members 178) includes a spring arm (arms/legs extending from biasing members 178, fig. 3) and the cover includes a finger (pegs 174, fig. 3), the spring arm engaged with the finger of the cover to urge the cover towards the first position (biasing members 178 bias knife guard 170 towards the storage position, fig. 5, [0058]).
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 4-5 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton et al. (US Patent Publ. No. 2021/0186501) in view of Gurumurthy et al. (US Patent Publ. No. 2012/0312861).
With respect to claims 4 and 14, Shelton et al. disclose the biasing member is secured to the central portion of the actuation sled (pins 40752 on central portion of sled), but fail to disclose a resilient finger that engages the base portion of the knife to urge the knife towards the lowered position.
Gurumurthy et al. disclose in a similar type of system that it is old and well known to have a biasing member having a resilient finger that engages a base portion of a rotatable member to urge the rotatable member toward a lowered position (torsion spring 152 having elongated legs/fingers to urge rotatable safety lockout 128 toward a position, fig. 17).
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 Shelton et al. device by substituting a torsion spring having a resilient finger as suggested by Gurumurthy et al., for the pins and ridges of Shelton et al., as the substitution of an art-recognized equivalent for biasing a rotatable element to a position. MPEP 2144.06 II. In this instance, a skilled artisan would have recognized that the substitution of the torsion spring having a resilient finger from the Gurumurthy et al. reference for pins and ridges of the Shelton et al. reference involves no more than the predictable use of prior art elements according to their established functions, and that one of ordinary skill in the art could have substituted one known element for another and the results of the substitution would have been predictable.
With respect to claims 5 and 15, Shelton et al. disclose the biasing member is secured to the central portion of the actuation sled (pins 40752 on central portion of sled), but fail to disclose a torsion spring that is engaged with the knife to urge the knife towards the lowered position.
Gurumurthy et al. disclose in a similar type of system that it is old and well known to have a torsion spring engaged with a rotatable member to urge the rotatable member into a lowered position (torsion spring 152 to urge rotatable safety lockout 128 toward a position, fig. 17).
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 Shelton et al. device by substituting a torsion spring as suggested by Gurumurthy et al., for the pins and ridges of Shelton et al., as the substitution of an art-recognized equivalent for biasing a rotatable element to a position. MPEP 2144.06 II. In this instance, a skilled artisan would have recognized that the substitution of the torsion spring from the Gurumurthy et al. reference for pins and ridges of the Shelton et al. reference involves no more than the predictable use of prior art elements according to their established functions, and that one of ordinary skill in the art could have substituted one known element for another and the results of the substitution would have been predictable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gupta et al. (U.S. Patent No. 9,271,728) disclose a rotatable knife cover.
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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/LINDA J. HODGE/Primary Examiner, Art Unit 3731
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