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 amendment filing on 08/27/2025.
Applicant’s cancelation of claims 1-15, 17, and 27-30 is acknowledged and require no further examining. Claims 19-21, 23-25, and 31-35 are withdrawn for being drawn to non-elected invention and non-elected species. Claims 16, 18, 22, and 26 are pending and examined below.
Upon further consideration, a new ground(s) of rejection is made in view of reference Smyers et al. (8,534,492). Due to the introduction of the new rejections, this action is made NON-FINAL.
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Claims 19-21, 23-25, and 31-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.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 Objections
Claim 16 is objected to because of the following informalities. Appropriate correction is required.
Regarding claim 16, the phrase “a longitudinal axis of the retainer; and a second retainer tab” appears to be a typographical error and should be written as “a longitudinal axis of the retainer; a second retainer tab”.
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, 18, 22, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over reference Shelton, IV et al. (10,172,617)(referred Shelton) in view of reference Smyers et al. (8,534,492).
Regarding claim 16, Shelton disclose a staple cartridge (70) comprising:
an elongate body (71),
wherein the elongate body (71) comprises a deck (73),
wherein the elongate body (71) defines a plurality of staple pockets (74), and
wherein each of the staple pockets (74) are accessible via an opening in the deck (73);
an implantable adjunct (200) removably secured to the deck (73); and
a retainer (300) removably securable to the elongate body (71),
wherein the retainer (300) comprises:
a first retainer tab (308) extending laterally with respect to the longitudinal axis of the retainer (300);
a second retainer tab (308) extending laterally with respect to the longitudinal axis of the retainer (300); and
a retainer body (302, 304) extending along the longitudinal axis
(Figure 5, 10-11 and Column 8 lines 8-15, Column 17 lines 15-24)
[AltContent: textbox (Retention Tabs)][AltContent: arrow][AltContent: arrow][AltContent: textbox (First Retainer Tab)][AltContent: arrow][AltContent: arrow][AltContent: textbox (Second Retainer Tab)][AltContent: textbox (Shelton)]
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In column 17 lines 21-26 of Shelton, the implantable adjunct (200) is disclosed to be compressed against the deck (73) in order to promote adhesion between the underside of the implantable adjunct (200) and the deck (73).
However, Shelton does 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, and does not disclose the first retainer tab and second retainer tab provide a force to compress the implantable adjunct against the deck.
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 a first position (Figure 4) to a second position (Figure 5),
wherein the first retainer tab and the second retainer tab (130), when in the second position (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 second position (Figure 5) than in the first position (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 5-8 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 retainer tab from the Smyers et al. reference for the fixed connection for the retainer tab of the Shelton 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, Shelton modified by Smyers et al. disclose the first retainer tab (Shelton – 308) and the second retainer tab (Shelton – 308) comprise an angled profile such that a portion of the respective tabs is positioned on a side of the elongated body (Shelton – 71) opposite the implantable adjunct (Shelton – 200). (Shelton – Figure 10-11)
Regarding claim 22, Shelton modified by Smyers et al. disclose one or more retention tabs (Shelton – 308) extending from the retainer (Shelton – 300), the retention tabs (Shelton – 308) being outwardly deflectable. (Shelton – Figure 10-11).
Regarding claim 26, Shelton modified by Smyers et al. disclose the first retainer tab (Shelton – 308) and the second retainer tab (Shelton – 308) are positioned centrally along a length between a distal end and a proximal end of an adjunct shelf (Shelton – 302, 304) to provide uniform compression along a length of the implantable adjunct (Shelton – 200). (Smyers et al. – Figure 3 and Column 3 lines 17-18, 39-41)
Response to Arguments
Applicant’s cancelation of claims 1-15, 17, and 27-30 is acknowledged and require no further examining. Claims 19-21, 23-25, and 31-35 are withdrawn for being drawn to non-elected invention and non-elected species. Claims 16, 18, 22, and 26 are pending in the application.
In response to the arguments of the rejections under 35 U.S.C. 112(b), in view of the amendments to the claims, Examiner withdraws the 112(b) rejections.
In response to the arguments of the rejections under 35 U.S.C. 102(a)(1) with reference Shelton, IV et al. (10,172,617), in view of the amendments to the claims, Examiner withdraws the 102 rejections. However, upon further consideration, a new ground(s) of rejection is made in view of reference Shelton, IV et al. (10,172,617) modified by reference Smyers et al. (8,534,492). Due to the introduction of the new rejections, this action is made NON-FINAL.
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 November 25, 2025
/STEPHEN F. GERRITY/Primary Examiner, Art Unit 3731 25 November 2025
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