DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the AIA first to file provisions. 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.
Application Status
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/2/2025 has been entered.
Claims 15-26 and 29-30 are currently pending and being examined.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 15, 17-25, and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Murray et al. US 2008/0082126 in view of Shelton et al. US 2007/0045379.
Regarding claim 15:
The combination of Murray and Swayze a surgical instrument system, comprising: a staple cartridge assembly (see FIG. 118; 508), comprising: a longitudinal slot (520); a first longitudinal row of first staple cavities (526) ,wherein each first staple cavity is oriented at a first angle (534) with respect to said longitudinal slot; a second longitudinal row of second staple cavities (528), wherein each second staple cavity is oriented at a second angle (536) relative to said longitudinal slot, wherein said second angle is different than said first angle; a plurality of first staples removably stored in said first longitudinal row of first staple cavities, wherein each first staple comprises a first staple base and first staple legs extending from said first staple base; and a plurality of second staples removably stored in said second longitudinal row of second staple cavities, wherein each second staple comprises a second staple base and second staple legs extending from said second staple base (all described in [0227]); a plurality of drivers (338) configured to eject said first staples from said first staple cavities and eject said second staples from said second staple cavities during a firing stroke ([0200]), wherein each driver is configured to eject one of said first staples [or] one of said second staples; and an anvil (602), comprising: a longitudinal row of first forming pockets (618) configured to deform the first staples during the firing stroke; and a longitudinal row of second forming pockets (618) configured to deform the second staples during the firing stroke (both envisaged in FIGS. 125 and 126, [0231]).
Murray does not teach wherein each driver comprises a ramp extending along a longitudinal ramp axis, wherein each ramp is drivingly engaged to eject one of said first staples and one of said second staples asymmetrically positioned relative to said longitudinal ramp axis.
However, this staple driver configuration is a well-known alternative to Murray’s one driver for one staple arrangement. For example, Swayze discloses the use of “double drivers” (330a), wherein each driver comprises a ramp (362) extending along a longitudinal ramp axis each configured to eject one of a first staple (222a) of a first longitudinal row of staples and one of a second staple (222b) of a second longitudinal row of staples (see FIGS. 13-15; [0099]-[0100]), teaching “only one inside driver configuration is employed which thereby eliminates the need for two different inside staple driver configurations for channels on each side of the elongated slot” ([0100]).
It would have been obvious to a person having ordinary skill in the art, at the effective filing date of the invention, to modify the drivers of Murray by using the ramped double driver arrangement of Swayze, such that each driver is configured to eject one of said first staples and one of said second staples asymmetrically positioned relative to said longitudinal ramp axis, since this would reduce the number of movable parts of the system while allowing the adjacent rows to be stapled in a more controlled and coupled manner, as taught by Swayze.
Regarding claim 17 and 27:
The combination of Murray and Swayze the surgical instrument system of claim 15, as discussed above, wherein the first staple legs of each said first staple comprise a proximal first staple leg and a distal first staple leg, and wherein said proximal first staple leg and said distal first staple leg are asymmetric prior to being deformed by said first staple forming pockets (Murray, e.g., as shown in FIG. 125, the sharp point of the end of the proximal leg is on the distal side of the proximal leg whereas the sharp point of the end of the distal leg is on the proximal side of the distal leg).
Regarding claim 18, 21, and 28:
The combination of Murray and Swayze the surgical instrument system of claim 17, as discussed above, wherein the second staple legs of each said second staple comprise a proximal second staple leg and a distal second staple leg, and wherein said proximal second staple leg and said distal second staple leg are asymmetric prior to being deformed by said second staple forming pockets (Murray, e.g., as shown in FIG. 125, the sharp point of the end of the proximal leg is on the distal side of the proximal leg whereas the sharp point of the end of the distal leg is on the proximal side of the distal leg).
Regarding claims 19 and 29:
The combination of Murray and Swayze the surgical instrument system of claim 15, as discussed above, further comprising a distal end and a firing drive including an electric motor and a firing member advanceable toward said distal end during a staple firing stroke to eject said first staples and said second staples from said staple cartridge assembly (Murray, [0179] last sentence).
Regarding claims 20-23 and 25:
The combination of Murray and Swayze the staple cartridge assembly of claims 20-23 and 25, as discussed in the rejections above.
Regarding claim 24:
The combination of Murray and Swayze teaches the staple cartridge assembly of claim 20, as discussed above, wherein said first proximal leg comprises a first bend prior to said first proximal leg being deformed against the anvil, wherein said first distal leg comprises a second bend prior to said first distal leg being deformed against the anvil, and wherein said first bend is at different height relative to said first staple base than said second bend (Murray, see FIGS. 96 and 98).
Regarding claim 30:
The combination of Murray and Swayze teaches the surgical instrument system of Claim 25, wherein each driver comprises a ramp extending along a longitudinal ramp axis, and wherein said first staple and said second staple supported by said driver are unequally spaced from said longitudinal ramp axis (envisaged in Swayze FIG. 14 when modified for Murray’s asymmetric staples).
Claims 16 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Murray and Swayze, as applied above, and further in view of Shelton et al. US 2007/0045379.
Regarding claims 16 and 26:
The combination of Murray and Swayze the surgical instrument system of claim 15, as discussed above, but does not teach wherein said first forming pockets are configured to deform said first staples to a first formed height, wherein said second forming pockets are configured to deform said second staples to a second formed height, and wherein said second formed height is different than said first formed height.
In a different surgical stapler, Shelton discloses “it would be advantageous for the staples that are closest to the cut line to have one formed height that is less than the formed height of those staples that are farthest from the cut line. In practice, the rows of inside staples serve to provide a hemostatic barrier, while the outside rows of staples with larger formed heights provide a cinching effect where the tissue transitions from the tightly compressed hemostatic section to the non-compressed adjacent section” ([0004]) and achieves this by having first forming pockets configured to deform first staples to a first formed height, second forming pockets configured to deform second staples to a second formed height, wherein said second formed height is different than said first formed height (see [0109] last three sentences).
It would have been obvious to a person having ordinary skill in the art, at the effective filing date of the invention, to modify the surgical instrument of the combination of Murray and Swayze by having first forming pockets configured to deform first staples to a first formed height, second forming pockets configured to deform second staples to a second formed height, wherein said second formed height is different than said first formed height, as taught by Shelton, since this would be advantageous for the tissue near the cut line, as discussed by Shelton.
Response to Arguments
Applicant’s remarks have been carefully considered but are not persuasive due to the new grounds of rejection made in this action, necessitated by amendment. Examiner maintains the position that it would have been obvious to a person having ordinary skill in the art, at the effective filing date of the invention, to use a ramped double driver, as taught by Swayze, adapted to fit the asymmetric arrangement of staples shown in the FIG. 118 embodiment of Murray, in order to “eliminate[] the need for two different inside staple driver configurations for channels on each side of the elongated slot” (Swayze, [0100]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DARIUSH SEIF whose telephone number is (408) 918-7542. The examiner can normally be reached on Monday-Friday 9:30 AM-6:00 PM PST.
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/DARIUSH SEIF/Primary Examiner, Art Unit 3731