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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-13 & 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sauer (US 2010/0211082).
Regarding claim 1, an invention relating to suturing devices, Sauer discloses (Figs. 1, 4, 6B, 8A, 13C) a prosthetic suturing device (10), comprising: a housing (22 & 24): a shaft (34) extending from a proximal end (34D) to a distal end (34A) along a shaft axis (see annotated figure below), wherein a first portion of the shaft is coupled to a first portion of the housing (Par. 0087 & 0096); an actuator (64) coupled to a second portion of the housing (Par. 0094), the actuator being displaceable between a first position (Fig. 13A) and a second position (Fig. 13C; Par. 0112); a guide tip (32) extending along the shaft axis from a proximal end (see annotated figure below) to a distal end (32J), a first portion of the guide tip being disposed at or adjacent to the distal end of the shaft (Par. 0087), wherein a notch (32R) is disposed along a second portion of the guide tip between the proximal end of the guide tip and the distal end of the guide tip, the notch extending from a distal end to a proximal end (see annotated figure below); a first needle [i.e. one of the needles from a pair of elongate needles (56)] extending from a proximal end (56E) to a distal end (56D) along a first needle axis (see annotated figure below), wherein a distal tip (56A) is disposed at the distal end of the first needle (Par. 0103), and wherein a first portion of the first needle is coupled to a first portion (see annotated figure below) of the actuator such that (a) when the actuator is in the first position, the distal tip of the first needle is disposed proximal to the proximal end of the notch, and (b) when the actuator is in the second position, the distal tip of the first needle is disposed distal to the distal end of the notch (Par. 0095 & 0112); a second needle [i.e. the other of the needles from the pair of elongate needles (56)] extending from a proximal end (56E) to a distal end (56D) along a second needle axis (see annotated figure below), wherein a distal tip (56A) is disposed at the distal end of the second needle (Par. 0103), and wherein a first portion of the second needle is coupled to a second portion (see annotated figure below) of the actuator such that (a) when the actuator is in the first position, the distal tip of the second needle is disposed proximal to the proximal end of the notch, and (b) when the actuator is in the second position, the distal tip of the second needle is disposed distal to the distal end of the notch (Par. 0095 & 0112); a needle guide tube (41) having first and second guide tracks (41D), wherein at least a portion of the needle guide tube is coupled to at least one of (a) a second portion of the shaft and (b) a third portion of the housing (Par. 0098), and wherein a second portion of the first needle is disposed within the first guide track and a second portion of the second needle is disposed within the second guide track (Par. 0103 & 0123) such that (a) the proximal end of the first needle and the proximal end of the second needle are aligned in a first plane [i.e. a plane parallel to the circular cross-section of the needle] proximal to the needle guide tube and (b) the distal end of the first needle and the distal end of the second needle are aligned in a second plane [i.e. a plane along the needle axes] distal to the needle guide tube, wherein the first plane is not parallel to the second plane [i.e. the planes are perpendicular] (Figs. 2 & 13B).
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Regarding claim 2, Sauer discloses the prosthetic suturing device of claim 1. Sauer further discloses wherein the wherein the first plane [i.e. a plane parallel to the circular cross-section of the needle] is perpendicular to the second plane [i.e. a plane along the needle axes] (Figs. 2 & 13B).
Regarding claim 3, Sauer discloses the prosthetic suturing device of claim 1. Sauer further discloses wherein at least a portion of the first needle axis is non-linear and at least a portion of the second needle axis is non-linear [i.e. the needles would be bent to navigate through the bent shaft] (Fig. 5; Par. 0035, 0093, 0099).
Regarding claim 4, Sauer discloses the prosthetic suturing device of claim 1. Sauer further discloses wherein a first portion of the first needle axis is not aligned with or parallel to a second portion of the first needle axis, and a first portion of the second needle axis is not aligned with or parallel to a second portion of the second needle axis [i.e. the needles would be bent to navigate through the bent shaft so one portion would be transverse to the other portion] (Fig. 5; Par. 0035, 0093, 0099).
Regarding claim 5, Sauer discloses the prosthetic suturing device of claim 1. Sauer further discloses wherein the proximal end of the first needle is coupled to the first portion of the actuator, and the proximal end of the second needle is coupled to the second portion of the actuator (Par. 0095).
Regarding claim 6, Sauer discloses the prosthetic suturing device of claim 1. Sauer further discloses wherein the shaft includes one or more interior surfaces [i.e. luminal wall] defining an interior portion [i.e. lumen], and wherein a portion of the first needle and a portion of the second needle are each disposed within the interior portion of the shaft (Par. 0093).
Regarding claim 7, Sauer discloses the prosthetic suturing device of claim 6. Sauer further discloses wherein at least a portion of the needle guide tube is disposed within interior portion of the shaft (Figs. 2 & 4).
Regarding claim 8, Sauer discloses the prosthetic suturing device of claim 1. Sauer further discloses wherein the proximal end of the shaft is coupled to the first portion of the housing (Par. 0093).
Regarding claim 9, Sauer discloses the prosthetic suturing device of claim 1. Sauer further discloses wherein the needle guide tube is elongated and extends along a tube axis (see annotated figure below) from a proximal end to a distal end, wherein the tube axis is aligned with the shaft axis.
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Regarding claim 10, Sauer discloses the prosthetic suturing device of claim 9. Sauer further discloses wherein the first guide track is formed along a first portion of an exterior surface of the needle guide tube, and the second guide track is formed along a second portion of the exterior surface of the needle guide tube (Figs. 6A & 8A; Par. 0103).
Regarding claim 11, Sauer discloses the prosthetic suturing device of claim 9. Sauer further discloses wherein the first guide track extends from the proximal end of the needle guide tube to the distal end of the needle guide tube, and the second guide track extends from the proximal end of the needle guide tube to the distal end of the needle guide tube (Figs. 6A & 8A).
Regarding claim 12, Sauer discloses the prosthetic suturing device of claim 9. Sauer further discloses wherein the proximal end of the needle guide tube is disposed at or adjacent to the proximal end of the shaft (Fig. 6A).
Regarding claim 13, Sauer discloses the prosthetic suturing device of claim 10. Sauer further discloses wherein the proximal end of the guide tip is disposed at or adjacent to the distal end of the shaft (Fig. 1).
Regarding claim 15, Sauer discloses the prosthetic suturing device of claim 1. Sauer further discloses wherein when the actuator is in the second position, the distal tip of the first needle is disposed at or adjacent to the distal end of the guide tip and the distal tip of the second needle is disposed at or adjacent to the distal end of the guide tip (Par. 0112).
Regarding claim 16, Sauer discloses the prosthetic suturing device of claim 1. Sauer discloses (Figs. 7B & 10B) the distal tip further comprising: a first channel (32F) that extends from the distal end of the notch to the distal end of the guide tip, wherein the distal tip of the first needle is configured to extend into the first channel when the actuator is displaced from the first position to the second position; and a second channel (32F) that extends from the distal end of the notch to the distal end of the guide tip, wherein the distal tip of the second needle is configured to extend into the second channel when the actuator is displaced from the first position to the second position (Par. 0104-0105, 0107).
Regarding claim 17, Sauer discloses the prosthetic suturing device of claim 16. Sauer discloses (Figs. 9A-D)further comprising: a first ferrule (52A) coupled to a first portion of suture (52C), the first ferrule disposed in a portion of the first channel, wherein the distal tip of the first needle is configured to releasably couple to the first ferrule when the actuator is displaced from the first position to the second position; and a second ferrule (52A) coupled to a second portion of suture, the second ferrule disposed in a portion of the second channel, wherein the distal tip of the second needle is configured to releasably couple to the second ferrule when the actuator is displaced from the first position to the second position (Par. 0103-0105).
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 14 is rejected under 35 U.S.C. 103 as being unpatentable over Sauer (US 2010/0211082) [i.e. Sauer’082] as applied to claim 10 above, and further in view of Sauer et al. (US 2005/0154402) [i.e. Sauer’402].
Regarding claim 14, Sauer’082 discloses the prosthetic suturing device of claim 10. Sauer’082 fails to further disclose wherein the first guide track and the second guide track each has a spiral shape that extends around the first portion and the second portion, respectively, of the exterior surface of the needle guide tube.
In the same field of endeavor, which is suturing devices, Sauer’402 teaches (Figs. 27A-F) wherein a first guide track having a spiral shape [i.e. obliquely oriented slot] that extends around the first portion of an exterior surface of a needle guide tube (138), respectively, of the exterior surface of the needle guide tube (Par. 0161).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sauer’082 to have wherein the first guide track and the second guide track each has a spiral shape that extends around the first portion and the second portion, respectively, of the exterior surface of the needle guide tube. Doing so would permits ferrule stripping (Par. 0161), as taught by Sauer’402. Also, 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 apparatus by duplicating the guide track having a spiral shape that extends around the portion of an exterior surface of a needle guide tube, respectively, of the exterior surface of the needle guide tube, such that the first guide track and the second guide track each has a spiral shape that extends around the first portion and the second portion, respectively, of the exterior surface of the needle guide tube, since it has been held that mere duplication of parts would not produce a new and unobvious result. In re Harza, 274 F.2d 669, 124 USPQ 378.
Claims 18 is rejected under 35 U.S.C. 103 as being unpatentable over Sauer (US 2010/0211082) [i.e. Sauer’082] as applied to claim 17 above, and further in view of Modesitt et al. (US 2003/0093093).
Regarding claim 18, Sauer’082 discloses the prosthetic suturing device of claim 17. However, Sauer’082 fails to further disclose wherein a proximal portion of the first channel has a first diameter and an intermediate portion of the first channel has a second diameter that is smaller than the first diameter, wherein the intermediate portion of the first channel is disposed between the distal end of the notch to the distal end of the guide tip; and wherein a proximal portion of the second channel has a first diameter and an intermediate portion of the second channel has a second diameter that is smaller than the first diameter, wherein the intermediate portion of the second channel is disposed between the distal end of the notch to the distal end of the guide tip.
In the same field of endeavor, which is suturing devices, Modesitt teaches (Figs. 6A-C) wherein a proximal portion of the first channel has a first diameter [i.e. the larger diameter located at needle receptacle (52) entrance] and an intermediate portion of the first channel has a second diameter [i.e. smaller diameter located in needle receptacle, adjacent distal fitting (40)] that is smaller than the first diameter, wherein the intermediate portion of the first channel is disposed between the distal end of the notch to the distal end of the guide tip; and wherein a proximal portion of the second channel has a first diameter [i.e. the larger diameter located at needle receptacle (52) entrance] and an intermediate portion of the second channel has a second diameter [i.e. smaller diameter located in needle receptacle, adjacent distal fitting (40)] that is smaller than the first diameter, wherein the intermediate portion of the second channel is disposed between the distal end of the notch to the distal end of the guide tip (Par. 0068).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sauer’082 to have wherein a proximal portion of the first channel has a first diameter and an intermediate portion of the first channel has a second diameter that is smaller than the first diameter, wherein the intermediate portion of the first channel is disposed between the distal end of the notch to the distal end of the guide tip; and wherein a proximal portion of the second channel has a first diameter and an intermediate portion of the second channel has a second diameter that is smaller than the first diameter, wherein the intermediate portion of the second channel is disposed between the distal end of the notch to the distal end of the guide tip. Doing so would guide the advancing needles into engagement with fittings/ ferrules (Par. 0068), and help to push the needles back into alignment with the fittings so as to overcome any unintended deflection of the needles by tissue or vessel wall (Par. 0089), as taught by Modesitt.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Chima Igboko whose telephone number is (571)272-8422. The examiner can normally be reached on Monday-Friday 9:00am-6:00pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jackie Ho, at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.U.I/ Examiner, Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 June 22, 2026
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