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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/12/26 has been entered.
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.
Claim(s) 1, 2, 7, 10, 11, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Laufer et al. (2005/0203552) in view of LoVuolo (6,595,911).
Claim 1:
Laufer discloses a needle (150) for deploying a T-bar suture (100) (Fig. 4a-c), comprising a footplate portion (102) (Fig. 4a-c) and a flexible thread portion (portion 106 is flexible however since the footplate is not positively claimed the needle is capable of delivering a t-bar with a flexible thread portion), the needle comprising: a feeding end (see figure below) comprising a first aperture (see figure below) for receiving the T-bar suture (Fig. 4a-c and [0038-42]); a pointed end (160) for creating an incision (Fig. 4a-c and [0038-42]), wherein the needle extends between the feeding end and the pointed end (Fig. 4a-c and [0038-42]); a second aperture (162, see figure below) proximal to and spaced from the pointed end (Fig. 4a-c and [0038-42]); wherein the second aperture extends through a wall of the needle (Fig. 4a-c and [0038-42]), wherein the first and second apertures are perpendicular to one another (Fig. 4a-b); a first needle portion (see figure below) extending between the feeding end and the second aperture (see figure below); and a second needle portion (see figure below) extending between the second aperture and the pointed end (see figure below); wherein the first and second needle portions are coaxially stacked (see figure below and Figure 4a-b where it is an elongated tubular member which is coaxial); the first needle portion comprising an interior channel (154) extending between the first aperture and the second aperture for transporting the T-bar suture from the first aperture to the second aperture (Fig. 4a-c and [0038-42]); wherein the interior channel comprises a deflection surface(see figure below) arranged to deflect the T-bar suture toward the second aperture (Fig. 4a-c and [0038-42]) and to deflect the footplate portion perpendicular to the second aperture when the T-bar suture is incident on the deflection surface (Fig. 4a-c and [0038-42]); wherein the footplate portion comprises a width perpendicular to the thread portion (Fig. 4a-c and [0038-42]) (note that the t-bar is not positively claimed therefore the needle of Laufer is capable of delivering a t-bar as stated), and a depth parallel to the thread portion (Fig. 4a-c and [0038-42]) (note that the t-bar is not positively claimed therefore the needle of Laufer is capable of delivering a t-bar as stated), and the interior channel comprises a bore wider than the depth of the footplate portion (Fig. 4a-c and [0038-42]) (note that the t-bar is not positively claimed therefore the needle of Laufer is capable of delivering a t-bar as stated), and narrower than the width of the footplate portion (Fig. 4a-c and [0038-42]) (note that the t-bar is not positively claimed therefore the needle of Laufer is capable of delivering a t-bar as stated).
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Laufer teaches all the claimed limitations discussed above however, Laufer does not disclose that the needle comprises markings indicating the side of the needle in which the second aperture is formed.
LoVuolo discloses another well known suture needle wherein the needle comprises markings (26, 46) (Fig. 1-2 and Col. 6 Line 55-Col. 7 Line 18) indicating the side of the needle in which the second aperture is formed (Fig. 1-2 and Col. 6 Line 55-Col. 7 Line 18 where it can indicate it).
It would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Laufer with markings in view of the teachings of LoVuolo, in order to indicate the orientation of the delivery needle (Col. 6 Lines 62-65).
Claim 2: wherein the pointed end comprises a bevel (Fig. 4b).
Claim 7: wherein a portion of the needle between the pointed end and the second aperture is closed (Fig. 4a).
Claim 10: wherein the deflection surface is on a side of the second aperture proximal to the pointed end of the needle (see figure above)
Claim 11: wherein the deflection surface comprises one side of the wall of the interior channel, which optionally forms a curve toward an edge of the second aperture proximal to the pointed end of the needle (see figure above).
Claim 14: wherein the needle is arranged to receive a pusher (156) for pushing the suture through the interior channel of the needle and out of the second aperture (Fig. 4a-c and [0038-42]).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Laufer et al. (2005/0203552) in view of LoVuolo (6,595,911) and further in view of Lamson et al. (10,105,132).
Laufer view of LoVuolo teaches all the claimed limitations discussed above however, Laufer view of LoVuolo does not disclose that the device is made of a material visible through fluoroscopic imaging or CT.
Lamson discloses another well known suture needle wherein the needle comprises a material visible through fluoroscopic imaging (Col. 59 Lines 54-67).
It would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Laufer view of LoVuolo with a material visible through fluoroscopic imaging or CT markings in view of the teachings of Lamson, in order to track and locate the needle during the operation.
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to use a material visible through fluoroscopic imaging or CT, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 15, 21, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Laufer et al. (2005/0203552) in view of LoVuolo (6,595,911) and further in view of Cantanese, III et al. (2008/0033488).
Laufer discloses all the limitations discussed above including a member (catheter, endoscope, etc as stated in [0010] and [0043]) for inserting into an orifice of the human or animal body (Fig. 4a-c and [0038-43]).
Laufer in view of LoVuolo discloses all the limitations discussed above including the use of a thread in LoVuolo however Laufer does not state that the t-bar has a thread portion as the connecting member and anchor nor that the member having a tapered end.
Cantanese discloses a kit for deploying sutures, comprising: at least one suture (16) (Fig. 6i-q and [0256-259]); at least one needle (210) (Fig. 6i-q and [0256-259]); and at least one pusher (64) (Fig. 6i-q and [0256-259]), arranged to push the suture through the interior channel of the needle and out of the second aperture (Fig. 6i-q and [0256-259]), wherein the at least one sutures are suture is a T-bar suture (Fig. 6i-q and [0256-259]); wherein each suture comprises a footplate portion (12) and a thread portion (16) (Fig. 6i-q and [0256-259]); wherein the suture comprises a free end (end connected to the pusher 32 as seen in Fig. 6o) and the kit comprises an anchoring device (12, 14) for securing the free end of each suture under tension at an anchoring point (where it is capable of performing this function) (Fig. 6i-q and [0256-259]); and further comprising a tunnelling device (32) for pulling the thread portion or free end of each suture through tissue to an anchoring point (Fig. 6i-q and [0256-259]).
Cantanese further discloses that the connecting member can be a variety of components including an elongate connector, tensioning member, filament, strand, thread, suture thread, string, wire, semi-rigid member, flexible member, elastic member, non-elastic member, resilient member, plastically deformable member, etc ([0041]). Thus, Cantanease discloses that these arrangements for the connecting member is well known equivalents in the art.
Therefore, it would have been obvious to one of ordinary skill in the art to modify the t-bar of Laufer to have a suture thread, as taught by Cantanese, since it has been held that a simple substitution of one known element for another will yield predictable results. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Canatanese discloses all the limitations discussed above including a member (28, resectoscope as stated [0163]) for inserting into an orifice of the human or animal body (Fig. 6i-q and [0256-259]), wherein the member is arranged to support the pointed end of the needle in a target human or animal tissue and wherein the member is cylindrical with a tapered end (Fig. 6i-q and [0256-259]).
Note that scopes are well known in the art and Laufer discloses that a variety of devices can be used as a member to assist in deliver ([0008], [0010], [0043]). Therefore member (28) of Canatanese could be used since it is a scope so it would be well known to be able to use such a device as a member in view of Laufer ([0008], [0010], [0043]).
Furthermore, it would have been obvious to one of ordinary skill in the art to modify the member of Laufer to have a tapered, as taught by Cantanese, since it has been held that a simple substitution of one known element for another will yield predictable results. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
In addition, it would have been obvious to one of ordinary skill in the art to modify the member of Laufer to have a tapered, as taught by Cantanese, in order to gradually reduce the diameter of the catheter/scope towards the tip, which helps it navigate, eases insertion, reduces trauma to tissues, and allows for smoother advancement in complex anatomy.
It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
Allowable Subject Matter
Claims 26 and 27 are allowed.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot in view of the new grounds of rejection.
Applicant's arguments filed 3/12/26 with respect to claim 15 have been fully considered but they are not persuasive.
In response to applicant's argument that an endoscope nor a catheter support the pointed end of the needle as claimed, 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANNE DORNBUSCH whose telephone number is (571)270-3515. The examiner can normally be reached Monday-Wednesday 9 am-3 pm.
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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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/DIANNE DORNBUSCH/Primary Examiner, Art Unit 3771
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