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 01/20/2026.
Applicant’s cancelation of claims 1-15, 17, 27-30, and 32 is acknowledged and require no further examining. Claims 19-21, 23-25, 31, and 33-35 are withdrawn for being drawn to a non-elected invention and species. Claims 16, 18, 22, and 26 are pending and examined below.
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Claims 19-21, 23-25, 31, and 33-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.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 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 (see figure 11 below) extending laterally with respect to the longitudinal axis of the retainer (300);
a second retainer tab (see figure 11 below) 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 16 lines 44-46 and 53-55 of Shelton, the tabs (308) are disclosed to be made of resilient material so that the retainer releasably secured to the elongate body.
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 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 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 – see figure 11 above) and the second retainer tab (Shelton – see figure 11 above) 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 – see figure 11 above) extending from the retainer (Shelton – 300), the retention tabs (Shelton – see figure 11 above) being outwardly deflectable. (Shelton – Figure 10-11).
Regarding claim 26, Shelton modified by Smyers et al. disclose the first retainer tab (Shelton – see figure 11 above) and the second retainer tab (Shelton – see figure 11 above) 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
The Amendments filed on 01/20/2026 have been entered. Applicant’s cancelation of claims 1-15, 17, 27-30, and 32 is acknowledged and require no further examining. Claims 19-21, 23-25, 31, and 33-35 are withdrawn for being drawn to a non-elected invention and species. Claims 16, 18, 22, and 26 are pending in the application.
In response to the arguments of the objections towards the claims, in view of the amendments to the claims, Examiner withdraws the claim objections.
In response to the rejections under 35 U.S.C. 103 with reference Shelton, IV et al. (10,172,617) modified by reference Smyers et al. (8,534,492), Examined finds the arguments not persuasive.
Applicant states:
The structure and function of the retention tabs, namely their ability to outwardly deflect and their lack of a living hinge, serves to secure the retainer to the staple cartridge without compressing the implantable adjunct.
In column 16 lines 53-55 of Shelton, IV et al., the retainer tabs are disclosed to be configured to releasably secure the retainer to the end effector. Shelton, IV et al. do not disclose the retainer tabs cannot or should not apply any pressure or force to the implantable adjunct. Rather, in column 17 lines 21-24 of Shelton, IV et al., a compressing force is disclosed to be applied to the implantable adjunct in order for the promote adhesion between the implantable adjunct and the elongate body.
Furthermore, since Applicant does not provide any evidence to support the assertion that a living hinge cannot be used, the assertion is mere speculation. “An assertion of what seems to follow from common experience is just attorney arguments and not the kind of factual evidence that is required to rebut a prima facie case of obviousness”. [MPEP 2145 (I)] Therefore, in view of Applicant no providing support for the assertion, and in view of Shelton, IV et al. disclosing the need of compressing force, Applicant’s argument is rendered moot.
Applicant states:
There is no motivation to modify Shelton’s resilient latches (308), which are “outwardly deflectable” retention tabs, at best, that do not and cannot “hinge” with the living hinge from Smyers.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, Shelton, IV et al. is not relied upon for teaching a tab that hinges nor the teaching of a living hinge. Shelton, IV et al. is relied upon for the teaching of a retainer removably securable to an elongated body, wherein said retainer comprises a first retaining tab and a second retainer tab. Smyers et al. is relied upon for the teaching of a device comprising a first retaining tab and a second retaining tab, wherein the first and second retaining tabs are connected to the body of the device via a living hinge. When modifying Shelton, IV et al. in view of Smyers et al., the first and second retaining tabs are interpreted to be connected to the retainer body of the retainer via living hinges.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. 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).
In column 16 lines 53-55 of Shelton, IV et al., the retainer tabs are disclosed to be configured to releasably secure the retainer to the end effector. In column 17 lines 21-24 of Shelton, IV et al., a compressing force is disclosed to be applied to the implantable adjunct in order for the promote adhesion between the implantable adjunct and the elongate body.
In column 1 lines 6-8 of Smyers et al., the use of retaining tabs including living hinges are disclosed to help overcome difficulties when securing the device to another element. In column 2 lines 34-37 of Smyers et al., the use of retaining tabs including living hinges are disclosed to apply compressing force to an adjunct situated on the device.
Therefore, since Shelton, IV et al. discloses the need of a retainer tab that releasably secure the retainer to the end effector and the need of applying compressing force to the implantable adjunct, and since Smyers et al. discloses retaining tabs including living hinges allows for easier securing and releasing of the retainer and allows compressing force to be applied, the person of ordinary skill in the art would be motivated to modifying Shelton, IV et al. in view of Smyers et al..
Conclusion
THIS ACTION IS MADE FINAL. 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 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 May 14, 2026
/SHELLEY M SELF/Supervisory Patent Examiner, Art Unit 3731
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