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 .
This Office Action is in response to the applicant’s RCE filing on 08/27/2026.
Applicant’s cancelation of claims 1-15, 17, 22, 27-30, 32, and 35 is acknowledged and require no further examining. Claims 19-21, 23-25, 31, and 33-34 are withdrawn for being drawn to a non-elected invention and species. Claims 16, 18, and 26 are pending and examined below.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/27/2026 has been entered.
Election/Restrictions
Applicant’s election without traverse of invention I and species I in the reply filed on 04/11/2025 and 06/25/2025 is acknowledged.
Claims 19-21, 23-25, 31, and 33-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/11/2025 and 06/25/2025.
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 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over reference Freidel et al. (11,497,494) in view of reference Shelton, IV et al. (10,172,617)(referred Shelton) and Smyers et al. (8,534,492).
Regarding claim 16, Freidel et al. disclose a stapling cartridge (37) comprising:
an elongated body (70),
wherein the elongated body (70) comprises a deck (72),
wherein the elongated body (70) defines a plurality of staple pockets (51), and
wherein each of the staple pockets (51) are accessible via an opening in the deck (72);
a retainer (100) removably securable to the elongate body,
wherein the retainer (100) comprises:
a first retainer tab (106) extending laterally with respect to a longitudinal axis of the retainer (100);
a second retainer tab (106) extending laterally with respect to a longitudinal axis of the retainer (100);
a retainer body (102) extending along the longitudinal axis,
wherein the first retainer tab (106) and second retainer tab (106) are connected to the retainer body (102), and
wherein the first retainer tab (106) and second retainer tab (106) engage the bottom surface of the staple cartridge (37) opposite the deck (72); and
one or more retainer tabs (104) extending from the retainer (100),
wherein the one or more retainer tabs (104) are distinct from the first retainer tab (106) and second retainer tab (106),
wherein the one or more retainer tabs (104) engage with the elongate body (70) to secure the retainer (100) to the elongate body such that the staple cartridge (37) and the retainer form a preassembled unit (Figure 8) insertable together into a channel of a first jaw frame (16) of an end effector (12)
(Figures 8-9, 12A-12B and Column 5 lines 44-46, 56-65)
However, Freidel et al. do not disclose an implantable adjunct removably secured to the deck, and do not disclose the first retainer tab and second retainer tab are connected to the retainer body via a first living hinge and a second living hinge, wherein the first retainer tab and second retainer tab provide a force to compress the implantable adjunct against the deck.
Shelton disclose a staple cartridge (70) comprising:
an elongate body (71),
wherein the elongate body (71) comprises a deck (73); and
an implantable adjunct (200) removably secured to the deck (73).
(Figure 12D and Column 8 lines 8-15, Column 15 lines 32-33)
It would have been obvious to the person of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to have modified the staple cartridge of Freidel et al. by incorporating the implantable adjunct as taught by Shelton, since column 12 lines 54-57 of Shelton states such a modification would provided reinforcement to the mechanical fastening of tissue provided by staples.
Smyers et al. discloses a device comprising:
a body (110);
a first retainer tab (130);
a first living hinge (140) connecting the first retainer tab (130) to the body (110);
a second retainer tab (130); and
a second living hinge (140) connecting the second retainer tab (130) to the body (110),
wherein the first retainer tab and the second retainer tab (130) are movable from an unfolded state (Figure 4) to folded state (Figure 5),
wherein the first retainer tab and the second retainer tab (130), when in the folded state (Figure 5), provide a force to compress an adjunct (40) against a surface (72), and
wherein the first retainer tab and the second retainer tab (130) are closer to the surface (72) in the folded state (Figure 5) than in the unfolded state (Figure 4).
(Figure 3-5 and Column 2 lines 19-23, Column 3 lines 7-14)
It would have been obvious to the person of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to have modified the tabs of Shelton by incorporating the living hinges of Smyers et al., since column 1 lines 6-8 of Smyers et al. states such a modification would allow easier securing of the retainer while providing compressing forces to the adjunct.
In this instance, a skilled artisan would have recognized that the substitution of the living hinge connection for the first and second retainer tabs from the Smyers et al. reference for the fixed connection for the first and second retainer tabs of the Freidel 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.
Regarding claim 18, Freidel et al. modified by Shelton and Smyers et al. disclose the first retainer tab (Freidel et al. – 106) and the second retainer tab (Freidel et al. – 106) comprise an angled profile such that a portion of the respective tabs is positioned on a side of the elongated body (Freidel et al. – 70) opposite the implantable adjunct (Shelton – 200). (Freidel et al. – Figure 8)
Allowable Subject Matter
Claim 26 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.
Response to Arguments
The Amendments filed on 08/27/2026 have been entered. Applicant’s cancelation of claims 1-15, 17, 22, 27-30, 32, and 35 is acknowledged and require no further examining. Claims 19-21, 23-25, 31, and 33-34 are withdrawn for being drawn to a non-elected invention and species. Claims 16, 18, and 26 are pending in the application.
In response to the arguments of the rejections under 35 U.S.C. 103 with reference Shelton, IV et al. (10,172,617) modified by Smyers et al. (8,534,492), in view of the amendments to the claims, Examiner withdraws the 103 rejections. However, upon further consideration, a new ground(s) of rejection is made in view of reference Freidel et al. (11,497,494).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK B FRY whose telephone number is (571)272-0396. The examiner can normally be reached on Mon-Thur 7am-4pm.
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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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/PATRICK B FRY/Examiner, Art Unit 3731 September 18, 2026
/JOSHUA G KOTIS/Examiner, Art Unit 3731
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