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 .
Response to Amendment
The amendments to claims 1-21 filed 05/01/2026 are acknowledged and the claim objections are withdrawn.
The amendments to claims 1 (to overcome the previous 112b rejection of claims 4 and 5) and 7 filed 05/01/2026 are acknowledged and the 112(b) rejections are withdrawn.
The amendment to claim 19 to define the indexing structure as the sidewall is acknowledged and the previous 112(d) interpretation is withdrawn.
Response to Arguments
Applicant’s arguments, see page 2, filed 05/01/2026, with respect to the rejection(s) of claim(s) 1-2, 4-7, 9-15, 19, and 20 under a 102 rejection over Torrie have been fully considered and are persuasive. The examiner agrees that Torrie fails to disclose or suggest “the shaft having a distal end that is blunt”. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Torrie in view of Weber et al. (US 20160338691).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4-7, 9-15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Torrie et al. (US 20220104804) [hereinafter Torrie] in view of Weber et al. (US 20160338691) [hereinafter Weber].
Regarding claim 1, Torrie discloses a device 100 (Fig. 5, para. 0046) comprising:
a tubular segment (interpreted as working end 104 which is a segment of tubular shaft 103, Fig. 5, para. 0046) having a first end face (see annotated Fig. 6B below), a second end (see annotated Fig. 6B below), a center axis L-L (Fig. 6A, para. 0047), and a sidewall extending from the first end face (see annotated Fig. 6C below), the sidewall having a first curved segment and a second curved segment (see annotated Fig. 6A below), the first end face contiguous with the second end and aligned on the center axis (see Fig. 6A, para. 0047), the sidewall forming a throat portion configured as an aperture 126 disposed proximate to the first end face and between the first end face and the second end (Fig. 6A, para. 0047: “Jaw 120 defines a cavity 125 for receiving tissue therein, the tissue entering through lateral opening 126”), further including a projection extending outward from the first end face (see annotated Fig. 6C below, Fig. 6D, para. 0051: “Cleat 132 includes a base 138 and spring arm 131 with a suture holding opening 134 therebetween”), the projection spaced proximally from a distal tip of the first end face (see annotated Fig. 6C below) and positioned between the first curved segment and the second curved segment (see Figs. 6D-F of Torrie which illustrates the projection positioned between the two lateral curved segments of the sidewall).
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Annotated Fig. 6C of Torrie
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Annotated Fig. 6A of Torrie
Torrie further discloses a needle 110 configured for axial movement relative to the tubular segment 104 and within a portion of the tubular segment in order to pierce through tissue and capture suture (Figs. 6A-C, para. 0050).
However, Torrie fails to disclose a shaft configured for axial movement relative to the tubular segment and within a portion of the tubular segment, the shaft having a distal end that is blunt and configured to exert a clamping force between the distal end of the shaft and a portion of the first end face.
Weber in the same field of endeavor of medical devices teaches that it is known in the art to include a shaft 40 configured for axial movement relative to a tubular segment (interpreted as distal end of tubular member 12 including distal jaw 10) and within a portion of the tubular segment (Figs. 1-2 and 6, para. 0025), the shaft 40 having a distal end that is blunt and configured to exert a clamping force between the distal end of the shaft and a portion of a first end face (interpreted as distal surface comprising opening 19, see Fig. 2, para. 0029) (see Figs. 10-11, para. 0041).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the device in Torrie to include the shaft of Weber in order to clamp and thereby stabilizing and securely holding the tissue in place before passing the needle therethrough (para. 0041 of Weber).
Regarding claim 2, modified Torrie discloses wherein the first end face is cantilevered to the sidewall (See Figs. 6A-B, 6D which illustrates the first end face affixed to the sidewall, para. 0051. The examiner notes that the interpretation is in light of page 2, lines 9-11 of the instant application’s specification).
Regarding claim 4, modified Torrie discloses wherein the projection includes a linear dimension aligned with a segment of the sidewall (see annotated Fig. 6A [1] of Torrie below).
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Annotated Fig. 6A [1] of Torrie
Regarding claim 5, modified Torrie discloses wherein the projection includes a cross section (see Fig. 6D, para. 0050-0051) configured to control rotary motion about the center axis (see note below).
Note: “configured to control rotary motion about the center axis” is interpreted as functional language and intended use of the device. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Since Torrie discloses all of the structural components (i.e. a projection having a cross-section) required for the functional limitation, Torrie thereby discloses the functional limitation such that the projection is capable of controlling rotary motion about the center axis. For example, the cross-section of the projection triangular such that it supports needle 110 (see Fig. 6D, para. 0051). Depending on the size of the needle, the cross-section of the projection is capable of allowing rotation of the needle about the center axis. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 6, modified Torrie discloses wherein the first end face is oblique relative to the center axis (see annotated Fig. 6A [2] of Torrie below).
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Annotated Fig. 6A [2] of Torrie
Regarding claim 9, modified Torrie discloses wherein the aperture 126 includes an edge having a non- perpendicular angle relative to the center axis (see annotated Fig. 6A [3] of Torrie below).
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Annotated Fig. 6A [3] of Torrie
Regarding claim 10, modified Torrie discloses wherein a proximal end of the shaft 40 is configured to engage with a manual actuator tool (interpreted as trigger mechanism 22; Fig. 1, para. 0033 of Weber: “The trigger mechanism 22 may consist of a finger lever 22 which, when actuated, is designed to move the proximal jaw 40 (movable member 40) relative to the distal jaw 10 (tip 10)”)).
Regarding claim 11, modified Torrie discloses wherein the second end of the tubular segment 104 is configured to engage with a manual actuator tool (interpreted as needle actuator 102; Fig. 5, para. 0046 of Torrie: “Passer 100 comprises a handle 101, a needle actuator 102 such as a lever, slide or button operatively coupled to the handle 101, an elongate shaft 103 extending distally from the handle 101, and a working end 104 defining a distal end of the passer 100”).
Regarding claim 12, Torrie discloses a device 100 (Fig. 5, para. 0046) comprising:
a foot affixed to a sheath 103 (see annotated Fig. 6A [5] below, para. 0047), wherein a portion of the foot is aligned with a longitudinal axis L-L of the sheath (see annotated Fig. 6A [5] below, para. 0047) , wherein the portion of the foot is a jaw face that includes a projection extending outward therefrom (see annotated Fig. 6C [1] below, para. 0051), wherein the projection is positioned proximal of a tip of the foot (see annotated Fig. 6D [1] below), between a first curved segment of a sidewall that extends between the foot and the sheath and between a second curved segment of the sidewall between the foot and the sheath (see annotated Fig. 6A above in regards to the first and second curved segments; see Figs. 6D-F of Torrie which illustrates the projection positioned between the two lateral curved segments of the sidewall), and wherein the sheath 103 includes a throat portion (interpreted as portion comprising opening 126) adjacent the foot (see annotated Fig. 6A [5] below, para. 0047).
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Annotated Fig. 6A [5] of Torrie
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Annotated Fig. 6C [1] of Torrie
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Annotated Fig. 6D [1] of Torrie
Torrie further discloses a needle 110 within the sheath 103, wherein the needle 110 is configured for axial movement relative to the sheath 103 and wherein a portion of the foot is aligned with a longitudinal axis of the needle 110 (Figs. 6A-C, para. 0050).
However, Torrie fails to disclose a shaft within the sheath, wherein the shaft is configured for axial movement relative to the sheath, wherein the shaft includes a distal end that is blunt, and wherein a portion of the foot is aligned with a longitudinal axis of the shaft.
Weber in the same field of endeavor of medical devices teaches that it is known in the art to include a shaft 40 within a sheath 12, wherein the shaft is configured for axial movement relative to the sheath 12 (Figs. 9-10, para. 0025), the shaft 40 includes a distal end that is blunt (see Figs. 10-11, para. 0041), and wherein a portion of a foot 10 is aligned with a longitudinal axis 40a of the shaft 40 (see Fig. 2, para. 0025).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the device in Torrie to include the shaft of Weber in order to clamp and thereby stabilizing and securely holding the tissue in place before passing the needle therethrough (para. 0041 of Weber).
Regarding claim 13, modified Torrie discloses wherein the throat portion 126 includes an aperture 125 in a sidewall of the sheath (Fig. 6A, para. 0047 of Torrie).
Regarding claim 14, Torrie discloses wherein the foot includes a clamp face aligned oblique with the longitudinal axis (see annotated Fig. 6A [6] of Torrie below).
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Annotated Fig. 6A [6] of Torrie
Regarding claim 15, modified Torrie discloses wherein the shaft 40 is configured to exert a compressive force in a direction of the clamp face (Fig. 10, para. 0041 of Weber).
Regarding claim 19, modified Torrie discloses wherein the foot includes the sidewall as an indexing structure to enable controllable rotation of an object engaged with the foot and the shaft (Fig. 6C, para. 0047 of Torrie; see note below).
Note: “to enable controllable rotation of an object engaged with the foot and the shaft” is interpreted as functional language and intended use of the device. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Since modified Torrie discloses all of the structural components (i.e. the foot having the sidewall) required for the functional limitation, modified Torrie thereby discloses the functional limitation such that the sidewall is capable of controlling rotation of an object engaged with the foot and the shaft. The curved configuration of the sidewall provides a barrier such that, depending on the size of the object, a level of rotation is capable of being provided to the object such as tissue 10a (see Fig. 6C of Torrie) held between the foot and the shaft. As shown in Fig. 6C of Torrie, the sidewall would limit, and thereby control rotation of the object since the tissue 10a abuts a portion of the sidewall. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 21, Torrie discloses wherein the shaft 40 includes a rounded end profile (see Fig. 2 of Weber).
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Torrie et al. (US 20220104804) [hereinafter Torrie] in view of Weber et al. (US 20160338691) [hereinafter Weber], as applied to claim 1 above, and further in view of Sinnott et al. (US 20130231669) [hereinafter Sinnott].
Regarding claim 7, modified Torrie discloses all of the limitations set forth above in claim 1. However, modified Torrie fails to disclose wherein the distal end of the shaft is oblique relative to the center axis.
Sinnott in the same field of endeavor of medical devices teaches that it is known in the art for a distal end 884 of a shaft 868 used for clamping an object (best shown in Fig. 47, para. 0085: “the tube 868 has been allowed to move against the bone 1080 under spring pressure to clamp the suture retriever 900 to the bone 1080”) to be oblique relative to a center axis 802 of the device (Figs. 28-29, para. 0072: “The guide 860 includes a hollow body 862 containing a clamping and guiding mechanism 864. The mechanism 864 includes a handle 866, a tube 868…The distal end of the tube 868 includes a bevel 884 and teeth 886 opposing the proximal facing surface 816 of the foot”).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the shape of the distal end of the shaft of modified Torrie to be beveled, and therefore oblique relative to the center axis as taught by Sinnot, since it has been held that the variations in shape were a matter of choice and only involves routine skill in the art. See In re Dailey, 357 F.2d 669, 149 USPQ (CCPA 1966). (See MPEP 2144.04).
Conclusion
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 LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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