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 .
DETAILED ACTION
This action is in response to applicant amendment received on 07/16/2026:
Amendments of Claims 21, 24, 30 and 32 are acknowledged.
Cancelation of Claims 25, 26 and 35-40 is acknowledged.
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 21 to 24 and 27 to 34 are rejected under 35 U.S.C. 103 as being unpatentable over Henderson (US 2012/0253298).
Regarding Claim 21:
Henderson discloses surgical instrument, comprising: (a) a first jaw; (b) a second jaw configured to cooperate with the first jaw to clamp and fasten tissue with a plurality of surgical fasteners; and (c) an adjunct that overlies a tissue contact surface of one or the first jaw or the second jaw and is configured to be penetrated by the surgical fasteners (Paragraph 0811, Figures 398, 399, stapling apparatus 20100 comprises an anvil 20105 that will be considered a second jaw and a staple cartridge 20110 that will be considered the first jaw, tissue thickness compensator 20130 will be considered the adjunct contacting the staple cartridge 20110 and staples 20120 will be considered the surgical fasteners),
the adjunct including: (i) a first adjunct layer comprising a first material and having a first thickness and a first compressibility, and (ii) a second adjunct layer overlying the first adjunct layer and comprising a second material different than the first material, the second adjunct layer having a second thickness greater than the first thickness and a second compressibility greater than the first compressibility (Figures 397 to 399, layer 20085 or 20140 will be considered first layers made of a film, while layer 20090 or 20145 are made of a biocompatible foam that will have more compressibility that the film layers),
wherein the first adjunct layer is sufficiently rigid to guide the surgical fasteners as they penetrate the first adjunct layer, wherein the second adjunct layer is sufficiently compressible to deform in response to closure of the first and second jaws (Figure 399 shows how the legs staples were guided across the adjunct towards the forming pockets on the anvil and compressing the foam layer 20145).
On this embodiment Henderson does not specifically disclose an adhesive layer configured to releasably attach the adjunct to the tissue contact surface, and a mesh material.
Henderson teaches using an adhesive layer to releasably attach the buttress material to the surface of the anvil or the cartridge (Paragraph 0582, buttress material 2560 can be removably attached to the surface 2541 by at least one adhesive, such as fibrin and/or protein hydrogel) and to include a mesh to the buttress material to provide additional flexibility, stiffness, and/or strength (paragraph 0702, a tissue thickness compensator could be reinforced with fibrous non-woven materials or fibrous mesh type elements, for example, that can provide additional flexibility, stiffness, and/or strength).
Therefore, it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to incorporate to the embodiment of Henderson of Figures 398, 399 the teachings of Henderson and use an adhesive layer to releasably attach the adjunct to the tissue contact surface since that is a common practice in the art, and a mesh material to provide additional flexibility, stiffness, and/or strength if required.
Regarding Claim 22:
Henderson discloses that the second adjunct layer is resiliently compressible and thereby configured to apply a compression spring force to the tissue through surgical fasteners fired on the tissue through the adjunct (Figure 399, layer 20145 is made of a biocompatible foam, and as any material it would have a degree of resiliency, when compressed by the staples 20120 as a reaction they would compress the tissue).
Regarding Claim 23 and 24:
Henderson discloses that the adjunct further includes a third adjunct layer that overlies the second adjunct layer such that the second adjunct layer is interposed between the first and third adjunct layers; the first and third adjunct layers comprise the same material and have the same thickness and compressibility, (Paragraph 0810, Figure 398, both layers 20135 and 20140 are made of a biocompatible film and overlay the foam layer 20145 so one of them can be considered as the first and the other the third adjunct layer, the first biocompatible film and second biocompatible film can comprise the same biocompatible material so they would have the same thickness and compressibility).
wherein the third adjunct layer is sufficiently rigid to guide the surgical fasteners as they penetrate the third adjunct layer (Figure 399 shows how the legs staples were guided across the adjunct towards the forming pockets on the anvil and penetrating both layers 20135 and 20140 ).
Regarding Claim 27:
Henderson discloses that the one or the first jaw or the second jaw includes a removable cartridge that houses a plurality of surgical fasteners and defines the tissue contact surface, the tissue contact surface having a plurality of openings through which the surgical fasteners are configured to be ejected (Paragraph 0748, Figure Jaw 20110 comprises a removable staple cartridge housing a plurality of staples 21210, a staple cartridge releasably hold a tissue thickness compensator to a support portion of the staple cartridge. In certain embodiments, the support portion can comprise a plurality of apertures defined in the deck surface, wherein the fasteners can extend through the tissue thickness compensator and can be releasably retained).
Regarding Claim 28:
Henderson discloses that the adjunct spans longitudinally and laterally across the tissue contact surface so as to overlie all of the openings (Figure 378 shows the tissue thickness compensator spanning longitudinally and laterally across the tissue contact surface to overlie all of the openings).
Regarding Claim 29:
Henderson discloses that the surgical fasteners comprise surgical staples, the surgical instrument further comprising an anvil configured to form the surgical staples (Paragraph 0533, Figure 399, staples 21210 that are deformed on forming pockets not numbered on the anvil, the staple forming surface or staple forming pockets have contacted the ends of the staple legs and have started to form or bend the legs over into a formed position).
Regarding Claim 30:
Henderson discloses surgical instrument, comprising:(a) a first jaw;(b) a second jaw configured to cooperate with the first jaw to clamp and fasten tissue with a plurality of surgical fasteners; and (c) an adjunct that overlies a tissue contact surface of one or the first jaw or the second jaw and is configured to be penetrated by the surgical fasteners (Paragraph 0811, Figures 398, 399, stapling apparatus 20100 comprises an anvil 20105 that will be considered a second jaw and a staple cartridge 20110 that will be considered the first jaw, tissue thickness compensator 20130 will be considered the adjunct contacting the staple cartridge 20110 and staples 20120 will be considered the surgical fasteners),
the adjunct including:(i) a first adjunct layer having a first thickness and a first compressibility,(ii) a second adjunct layer overlying the first adjunct layer and having a second thickness greater than the first thickness and a second compressibility greater than the first compressibility, and (iii) a third adjunct layer overlying the second adjunct layer and having the first thickness and the first compressibility (Paragraph 0811, Figures 398 and 399, a tissue thickness compensator 20130 comprising a first layer 20135, a second layer 20140, and a third layer 20145 that will be considered the second adjunct layer that is a foam layer, more compressible that 20135 and 20140, that can be made of the same film material, so they would have the same compressibility, Paragraph 0810, the first biocompatible film and second biocompatible film comprise the same biocompatible material),
wherein the first and third adjunct layers are sufficiently rigid to guide the surgical fasteners as they penetrate the first and third adjunct layers (Figure 399 shows how the legs staples were guided across the adjunct towards the forming pockets on the anvil and compressing the foam layer 20145),
wherein the second adjunct layer is sufficiently compressible to deform in response to closure of the first and second jaws (Figure 399 shows the foam 20145 being compressed after closure of the jaws).
On this embodiment Henderson does not specifically disclose a fourth adjunct layer overlying the first adjunct layer and configured to be interposed between the first adjunct layer and the tissue contact surface, wherein one of the fourth adjunct layer or the second adjunct layer comprises a mesh.
Henderson teaches using an adhesive layer to releasably attach the buttress material to the surface of the anvil or the cartridge (Paragraph 0582, buttress material 2560 can be removably attached to the surface 2541 by at least one adhesive, such as fibrin and/or protein hydrogel) and to include a mesh to the buttress material to provide additional flexibility, stiffness, and/or strength (paragraph 0702, a tissue thickness compensator could be reinforced with fibrous non-woven materials or fibrous mesh type elements, for example, that can provide additional flexibility, stiffness, and/or strength).
Therefore, it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, to incorporate to the embodiment of Henderson of Figures 398, 399 the teachings of Henderson and use an adhesive layer to releasably attach the adjunct to the tissue contact surface since that is a common practice in the art, and include a mesh material to the second adjunct layer to provide additional flexibility, stiffness, and/or strength if required.
Regarding Claim 31:
Henderson discloses that the third adjunct layer is opposed from the first adjunct layer about the second adjunct layer (Figure 398, layers 20135 and 20140 are in opposite sides of foam layer 20145, considered the second adjunct layer).
Regarding Claim 32:
Henderson discloses that the first and third adjunct layers comprise a first material and the second adjunct layer comprises a second material different than the first material (Paragraph 0810, the tissue thickness compensator may comprise a first biocompatible film and a second biocompatible film, and a biocompatible foam disposed between the first biocompatible film and second biocompatible film, so they are different materials one is a film and the second is a foam, first biocompatible film and second biocompatible film comprise the same biocompatible material); and as discussed for Claim 30 above, the fourth adjunct layer comprises and adhesive, such as fibrin and/or protein hydrogel, that will be considered a third material different than the first and second materials.
Regarding Claim 33:
Henderson discloses that the second adjunct layer is resiliently compressible and thereby configured to apply a compression spring force to the tissue through surgical fasteners fired on the tissue through the adjunct (Figure 399, layer 20145 is made of a biocompatible foam, and as any material it would have a degree of resiliency, when compressed by the staples 20120 as a reaction they would compress the tissue).
Regarding Claim 34:
Henderson discloses that the surgical fasteners comprise surgical staples, the surgical instrument further comprising an anvil configured to form the surgical staples (Figure 399, plurality of staples 20120 will be considered the surgical fasteners, anvil 20105 comprise not numbered forming pockets to deform the legs of the staples).
Response to Arguments
Applicant’s arguments with respect to the rejection of the claim under Henderson (US 2012/0253298) have been considered but are moot because the subject matter of the amended claims is also taught by other embodiments of the same reference. Certainly, the embodiment of Figures 389, 389 does not disclose the use of an adhesive layer to releasably attach the adjunct to the tissue contact surface or the use of a mesh, but those are both well-known practices in the art as it was shown on the rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, in particular Aronhalt (US 2014/0224857), Baxter (US 2012/0241499) and Gonzalez (US 2016/0345976) disclose similar adjuncts with 3 or more layers that could have been used for a proper rejection of at least the independent claims.
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 EDUARDO R FERRERO whose telephone number is (571)272-9946. The examiner can normally be reached M-F 9:30-7:00.
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, 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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/EDUARDO R FERRERO/Examiner, Art Unit 3731
/ROBERT F LONG/Primary Examiner, Art Unit 3731
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