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 12/05/2024 has been entered. Claims 1-20 are pending in the application.
Claim Objections
Claim 11 is objected to because of the following informalities: In claim 11, the term “clip roller” is recited but there is no recitation of a clip. Examiner is interpreting “clip roller” as a wheel/roller. Appropriate correction is required.
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) 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bakos et al. (US 20220079592 A1).
Regarding claim 11, Bakos et al. discloses an anvil buttress loading assembly (600, [0106-0111], fig. 25) comprising: an anvil buttress loading tool including a carrier (604) having a support plate (608) and a clip roller (644) extending proximally from the support plate (fig. 26 shows rollers 644 on proximal and distal ends of plate 608); and an anvil buttress (304) including a buttress body (figs. 14-17 and 26), the anvil buttress releasably retained on the anvil buttress loading tool with the buttress body positioned on the support plate ([0106-0113], figs. 25-26).
Regarding claim 12, Bakos et al. discloses the clip roller includes a post (642) extending proximally from the support plate (642- is proximal with a post extend from the roller 644) and a cylinder (roller pin securing roller 644 to post 642) extending laterally from the post ([0108]).
Claim(s) 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bruns et al. (US 20200237368 A1).
Regarding claim 17, Bruns et al. discloses tool assembly (812, [0166], fig. 21) comprising: a staple cartridge assembly (37 [0099, 0170]); and an anvil assembly (818) including a tissue facing surface (inner surface of 818/819) and a snap clip (821) disposed on the tissue facing surface (base 825/835 inserted into anvil tissue facing surface, [0171-0177], fig. 24), the snap clip movable between a closed position having a generally concave shape relative to the tissue facing surface (deformable first discrete curved orientation position fig. 24) and an open position having a generally convex shape relative to the tissue facing surface (second discrete position flared orientation [0169-0177], figs. 28-29).
Regarding claim 18, Bruns et al. discloses in the closed position, a free end (converging ends 827 and rivet 829) of the snap clip (821) is adjacent to the tissue facing surface (fig. 24) and, in the open position (figs. 28-29), the free end of the snap clip is spaced from the tissue facing surface (free end converging ends 827 and rivet 829 in open position fig. 24 is curved closer/adjacent tissue facing surface and open position figs. 28-29 is opened away/spaced further from tissue facing surface).
Claim(s) 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton, IV et al. (US 20180271520 A1).
Regarding claim 17, Shelton, IV et al. discloses tool assembly (31012, fig. 225) comprising: a staple cartridge assembly (staple cartridge 30/25000, [0354, 0368, 0530] figs. 1 and 207); and an anvil assembly (31060) including a tissue facing surface (surface having forming pockets 31066) and a snap clip (inner film 31024 and outer film 31022) disposed on the tissue facing surface (figs. 225-227), the snap clip movable between a closed position having a generally concave shape relative to the tissue facing surface (fig. 225) and an open position having a generally convex shape relative to the tissue facing surface (capable of being “moveable” to an open position either by deforming/bending or flipping upside down, [0538-0540], figs. 225-227).
Regarding claim 18, Shelton, IV et al. discloses in the closed position, a free end (31027/31023) of the snap clip (inner film 31024 and outer film 31022) is adjacent to the tissue facing surface (surface having forming pockets 31066, fig. 227) and, in the open position, the free end of the snap clip is spaced from the tissue facing surface (as discussed “open position” can be moved away from the anvil, away from the tissue facing surface or bent).
Regarding claim 19, Shelton, IV et al. discloses an anvil buttress (31026) having a proximal portion and a distal portion, the proximal portion releasably retained on the anvil assembly by the snap clip (inner film 31024 and outer film 31022) when the snap clip is in the closed position ([0538-0540], figs. 225-227).
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) 13-14 is/are rejected under 35 U.S.C. 103 as obvious over Bakos et al. (US 20220079592 A1) alone.
Regarding claims 13-14, Bakos et al. teaches the anvil buttress loading tool (604) includes a pair of proximal protrusions (342/retainer arms 228 [0064-0065, 0073-0074]) extending from the support plate and the anvil buttress includes a pair of proximal tabs (346 and/or 344 mechanical attachment feature similar to 342/228 [0073-0074]) extending from the buttress body, the pair of proximal tabs engaged with the pair of proximal protrusions ([0073-0074], figs. 12-17) and Bakos et al. teaches having up to four roller/arms (644/642) with two on each side of 608 and teaches having “other versions, movable member may be in the form of a slider, a puck, a ski, or any other structure known in the art that facilitates linear translation of a body relative to a chassis” [0108-0109] but fails to teach the tabs and protrusions in the embodiment off figs. 25-26 and that the clip roller is disposed between the pair of proximal protrusions.
Given the teachings of Bakos et al. to have a mechanical attachment features with protrusions extending from the support plate and the anvil buttress includes a pair of proximal tabs and having up to four roller/arms on each side, 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 pair of proximal protrusions extending from the support plate and the anvil buttress includes a pair of proximal tabs extending from the buttress body, the pair of proximal tabs engaged with the pair of proximal protrusions and the clip roller is disposed between the pair of proximal protrusions to have precise secure attachment of the buttress, add more rollers for guiding/alignment, reducing friction and/or for easier insertion of the loader in the jaws as taught by Bakos et al.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as obvious over Bakos et al. (US 20220079592 A1) in view of Shelton, IV et al. (US 20180235626 A1) and further in view of Shelton, IV et al. (US 20180271520 A1).
Regarding claims 15-16, Bakos et al. teaches the anvil buttress loading tool (604) has a film (346) and teaches having a loading block/base (302) but fails to disclose the anvil buttress loading tool further includes a cover disposed over the support plate of the carrier, wherein the cover includes a distal protrusion extending outwardly from an outer surface of the cover and a distal opening disposed proximal to the distal protrusion, and the anvil buttress includes a distal flap, the distal flap extending through the distal opening and engaged with the distal protrusion.
Shelton, IV et al.’626 teaches having an anvil buttress loading tool (6800) further with a cover (elastic member 6810) disposed over a support plate (6806/6808) of a carrier (6802/6804) for attaching buttress (6275 [0435-0440], fig. 53) and teaches having cover (14607) on the buttress or on the loader (14305) to aid in attaching a buttress ([0772-0781], figs. 115-124) wherein the cover includes a distal protrusion (gripping members 6814a, 6814b) extending outwardly from an outer surface of the cover (fig. 53) and a distal opening disposed proximal to the distal protrusion (slot between 6814a/b for buttress 6274), and the anvil buttress includes a distal flap, the distal flap extending through the distal opening and engaged with the distal protrusion (end portions of buttress 6274 are flaps with openings that engage protrusions 6814a/b).
Shelton, IV et al.’520 teaches having an anvil buttress loading tool (31020, fig. 225) further with a cover (inner film 31024) disposed over a support plate (31021) of a carrier (outer film 31022) for attaching buttress (compensation material 31026) and teaches having flanges (31025) with catch/protrusion (31027) to attach to anvil (31060) in groove (31064) of the anvil ([0538-0540], figs. 225-227). Shelton, IV et al.’520 also teaches having a loading tools (19/200/19500 with protrusions figs. 71 and 90-100) and a loading tool (19400) with holes and protrusions to attach buttress (fig. 84).
Given the teachings of Bakos et al. to have a mechanical attachment features, base, and a film to attach a buttress, 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 anvil buttress loading tool to include a cover disposed over the support plate of the carrier wherein the cover includes a distal protrusion extending outwardly from an outer surface of the cover and a distal opening disposed proximal to the distal protrusion, and the anvil buttress includes a distal flap, the distal flap extending through the distal opening and engaged with the distal protrusion to have support for the buttress, aid in attaching the buttress and/or for having an elastic cover for compressing the buttress in the jaws as taught by Shelton, IV et al.’626 and Shelton, IV et al.’520
Allowable Subject Matter
Claims 1-10 are allowed.
Claims 20 is 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 an anvil buttress loading system comprising all the structural and functional limitations and further comprising, amongst other limitations/features, an anvil assembly including a tissue facing surface and a snap clip disposed on the tissue facing surface, the snap clip movable between a closed position having a generally concave shape relative to the tissue facing surface and an open position having a generally convex shape relative to the tissue facing surface; an anvil buttress loading tool including a carrier having a support plate and a clip roller extending proximally from the support plate; and an anvil buttress including a buttress body, the anvil buttress releasably retained on the anvil buttress loading tool with the buttress body positioned on the support plate, the anvil buttress transferrable from the anvil buttress loading tool to the anvil assembly such that the buttress body is captured between the snap clip and the tissue facing surface of the anvil assembly, the snap clip movable from the closed position to the open position by the clip roller when advancing the anvil buttress loading tool onto the anvil assembly and from the open position to the closed position when separating the anvil buttress loading tool from the anvil assembly. Though Bakos et al. (US 20220079592 A1).teaches a similar anvil buttress loader with rollers, Bakos et al. fails to disclose snap clip disposed on the tissue facing surface to have the anvil buttress “transferrable from the anvil buttress loading tool to the anvil assembly such that the buttress body is captured between the snap clip and the tissue facing surface of the anvil assembly, the snap clip movable from the closed position to the open position by the clip roller when advancing the anvil buttress loading tool onto the anvil assembly and from the open position to the closed position when separating the anvil buttress loading tool from the anvil assembly” . Having the efficiency and ease of a buttress loader having a snap clip open/closed with a roller to secure the buttress onto the anvil, provides and effective secure buttress loading system.
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