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 action is in response to the amendment and remarks received on June 27, 2025.
Response to Arguments
Applicant's arguments filed June 27, 2025 have been fully considered but they are not persuasive.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper.1
In this case, the rejection of SWAYZE et al. in view of the secondary teachings of ARONHALT et al. specifically relies upon the knowledge of ARONHALT et al. per column 119 lines 53-57. Examiner maintains that it would have been obvious to one having ordinary skill in the art at the time of filing the invention to have modified the adjunct of SWAYZE et al. to utilize a moisture-sensitive shape memory material as claimed since column 119 lines 53-57 of ARONHALT et al. suggest such a modification will cause the adjunct to provide compression to the tissue to which it is attached for the purpose of improving the hemostatic behavior of the tissue.
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.2 Applicant argues on page 8 of the June 27, 2025 remarks that neither SWAYZE et al. nor ARONHALT et al. disclose the combined features of tabs for securing a tissue effecting portion from a moisture-sensitive material. As shown in Diagram I below, SWAYZE et al. clearly discloses tabs for securing a tissue effecting portion to a stapling surface of an end effector. ARONHALT et al. is relied upon for its teachings in the art to form tissue-effecting surfaces from a moisture-sensitive material. The rejection of the claimed invention as unpatentable over the combined disclosures of SWAYZE et al. in view of ARONHALT et al. is found to be proper.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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 21, 22 and 24-37are rejected under 35 U.S.C. 103 as being unpatentable over SWAYZE et al. (US 2015/0196296) in view of ARONHALT et al. (US 9,386,984).
In reference to claims 21, 22, 27 & 29, SWAYZE et al. discloses an adjunct 736 comprising: a plurality of tabs 714 coupled to a tissue-effecting portion (figure 33) that extends in a longitudinal direction (B, figure 1), the tabs 714 comprising a polymeric shape memory material (claim 17) that transition from a first state (compressed to press-fit within aperture 704) to a second state (deflected for removal from aperture 704) to releasably attaches the tissue-effecting portion to a stapling surface of stapler end effector (paragraph [0097]); wherein the tissue-effecting portion is configured to contact tissue clamped by the end effector during closure thereof, and wherein the tissue-effecting portion is further configured to be pierced and captured by staples ejected from the end effector (figure 2). SWAYZE et al. does not disclose the adjunct to be specifically formed from a moisture-sensitive shape memory material.
ARONHALT et al. teaches an adjunct formed from a composite shape memory material, such as foam, that is moisture-sensitive; wherein the adjunct is configured to absorb fluid from tissue to which the adjunct is attached thereby allowing the adjunct to have a first stiffness prior to absorption of fluid and a second stiffness post absorption (column 119 line 31- column 120 line 5). It would have been obvious to one having ordinary skill in the art at the time of filing the invention to have modified the adjunct of SWAYZE et al. to utilize a moisture-sensitive shape memory material as claimed since column 119 lines 53-57 of ARONHALT et al. suggest such a modification will cause the adjunct to provide compression to the tissue to which it is attached for the purpose of improving the hemostatic behavior of the tissue.
Regarding claims 24-26, SWAYZE et al. discloses an adjunct having at least one integral tab 714 formed from a polymeric shape memory material that permits the tab(s) to be compressed into a first state to pass through a recess 704 and expanded to an/the uncompressed state to releasably secure the adjunct to a deck of the end effector 14.
Regarding claim 28, SWAYZE et al. discloses the plurality of tabs 714 to be transversely-opposed (see Diagram I below of figure 33) and coupled to outer sides of the tissue-effecting portion.
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Diagram I
With respect to claims 32 and 33, SWAYZE et al. discloses the tissue-effecting portion of the adjunct B to have a lattice structure (figures 62-63; claim 17, 21 & 22) integral with compressible nodules 1305.
In reference to claim 35, SWAYZE et al. discloses a surgical stapler (figure 1) including an end effector 14 comprising: a first stapling surface cooperating with a second stapling surface to clamp and staple tissue T; and an adjunct B having a plurality of tabs 714 coupled to a tissue-effecting portion (figure 33) that extends in a longitudinal direction, the tabs 714 comprising a polymeric shape memory material (claim 17) that transition from a first state (compressed to press-fit within aperture 704) to a second state (deflected for removal from aperture 704) to releasably attaches the tissue-effecting portion to a stapling surface of stapler end effector (paragraph [0097]); wherein the tissue-effecting portion is configured to contact tissue clamped by the end effector during closure thereof, and wherein the tissue-effecting portion is further configured to be pierced and captured by staples ejected from the end effector (figure 2).
In reference to claims 36 & 37, SWAYZE et al. discloses a stapling body (figure 1) including an upwardly-facing deck 728 having at least one recess 704; an adjunct B including a tissue-effecting portion (figure 33) that extends in a longitudinal direction (figure 1), the tabs 714 comprising a polymeric shape memory material (claim 17) removably received within the at least one recess 704 to releasably attach the tissue-effecting portion to the deck of the stapling body (paragraph [0097]); wherein the tissue-effecting portion is configured to contact tissue clamped by the end effector during closure thereof, and wherein the tissue-effecting portion is further configured to be pierced and captured by staples ejected from the end effector (figure 2).
With respect to claims 30 & 31, SWAYZE et al. discloses an adjunct including a tissue-effecting portion integrally formed with deformable tabs 714, but does not disclose whether and/or how the material of the adjunct reacts to moisture.
ARONHALT et al. teaches an adjunct formed from a composite shape memory material, such as foam, that is moisture-sensitive; wherein the adjunct is configured to absorb fluid from tissue and subsequently (automatically) deform in a transverse direction (expand; column 119 lines 38-53). It would have been obvious to one having ordinary skill in the art at the time of filing the invention to have modified the adjunct of SWAYZE et al. to utilize a moisture-sensitive shape memory material as claimed since column 119 lines 53-57 of ARONHALT et al. suggest such a modification will cause the adjunct to provide compression to the tissue to which it is attached for the purpose of improving the hemostatic behavior of the tissue.
Allowable Subject Matter
Claims 38-40 are allowed.
The following is an examiner’s statement of reasons for allowance: Upon examination, the art considered as a whole, alone or in combination, neither anticipated nor renders obvious the claimed method of applying an adjunct to an end effector of a surgical stapler comprising the steps of transitioning at least one tab 714 of the adjunct from a first state of a first stiffness to a second stiffness less than the first stiffness; and transitioning the at least one tab from the second state to the first state, thereby deforming the at least one tab into at least one respective recess of the end effector for the purpose of selectively attaching the adjunct to the end effector.
The prior art discloses the knowledge in the art to provide an adjunct with tabs formed from a deformable and moisture reactive material that allows the adjunct and tabs to change degrees of stiffness. However, the prior art teaches such adjuncts releasable attached to an end effector in a reverse manner than what is claimed; that is, the adjunct transitions from the first state to the second state after the tab has deformed into the respective recess rather than a means to facilitate deformation of the tab into the respective recess. Thus, it is Examiner’s opinion that it would not have been obvious to one having ordinary skill in the art at the time of the invention to combine or modify the prior art in order to arrive at Applicant's invention as claimed.
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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Refer to the attached PTO-892 for a notice of references cited and recommended for consideration based on their disclosure of limitations related to the claimed invention.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 GLORIA R WEEKS whose telephone number is (571)272-4473. The examiner can normally be reached M-F 8am-2pm & 5pm-7pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thanh Truong can be reached on 571-272-4472. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GLORIA R WEEKS/Primary Examiner, Art Unit 3731
October 4, 2025
1 See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
2 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).