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 § 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, 3, 4, 6, 7, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hayhurst (5,810,848) in view of Karasic et al. (2020/0113586).
Claim 1:
Hayhurts discloses a proximal handle (see figure below) connected to a distal guide end (see figure below) by a shaft (see figure below); at least a first lumen (22) and a second lumen (24) (Fig. 2-3 and Col. 2 Lines 36-47), the first and second lumens extending through the handle and the shaft (see figure below); and a third lumen (see figure below) extending through the guide end (see figure below); wherein the first lumen and second lumens converge into the third lumen at the guide end (see figure below and Col. 2 Lines 36-47); wherein a suture slot (70) extends from the guide end to a position on the shaft (Fig. 12 and Col. 4 Lines 30-37).
Hayhurst teaches all the claimed limitations discussed above however, Hayhurts does not disclose that the guide end is angled relative to a longitudinal axis of the handle and shaft by an angle between about 15 and 45 degrees.
Karasic discloses discloses another well-known anchor delivery and drill device that can either use a shaft with an angled guide end (30) on shaft (20) (Fig. 2a-b and [0027-28]) and or a straight guide end (30) on shaft (22) (Fig. 2a-b and [0027-28]). Karasic further states that the guide end is angled relative to a longitudinal axis of the handle (26) and shaft (20) by an angle between about 15 and 45 degrees (Fig. 2a and [0028]).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the guide end of Hayhurst to have an angle of 15 degrees, as taught by Karasic, 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).
Furthermore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Hayhurst with angled distal end in view of the teachings of Karasic, in order to direct passing instruments around anatomy during surgery, especially anatomy that prevents a straight trajectory ([0026]).
The combination of Hayhurst in view of Karasic would have an angled guide end wherein the suture slot (70 of Hayhurst) has the angle and extends from the guide end to a position on the shaft proximal of the angle (Fig. 12 of Hayhurst where the slot extends proximal the guide end 30).
Claim 3: Hayhurts discloses wherein an anchor introducer (60) (Fig. 2-5) engageable to a suture anchor (44, 46, 48, 50) (Fig. 2-5) at a distal end is positioned in the second lumen such that the suture anchor is extendable out of the second lumen, through the third lumen, and past the guide end (Fig. 2-5)
Claim 4: Hayhurts discloses wherein the guide end comprises a pointed or serrated tip (34) (Fig. 2-3 and Col. 2 Lines 52-55).
Claim 6: Hayhurts discloses wherein the first lumen and the second lumen are stacked in a direction of the guide end angle (see figure below where they are stacked along the longitudinal axis).
Claim 7: Hayhurts discloses wherein the first lumen, the second lumen, and the third lumen each comprise a plurality of apertures (Fig. 2-12 where each have the distal opening where the lumen ends, the proximal opening where the lumen starts, and the second and third lumen have the slot 70 which is an opening on the side).
Claim 9: Hayhurts discloses wherein the first lumen and/or the second lumen comprises a spring-loaded button (12) (Fig. 1 that when pressed causes the rod 60 in the second lumen to move the anchors through the lumen).
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Claim(s) 1-3, 6, and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoeppnner (2015/0250469) in view of Fortier et al. (4,661,110) and further in view of Karasic et al. (2020/0113586).
Claim 1:
Hoeppner discloses an anchor drill device (20) (Fig. 3-5) comprising a distal guide end (see figure below) (Fig. 2a-5 and [0033]) and a shaft (60) (Fig. 2a-5); at least a first lumen (66) and a second lumen (68) (Fig. 2a-5 and [0033]), the first and second lumens extending through the shaft (Fig. 2a-5); and a third lumen (76) (Fig. 2a-5 and [0033]) extending through the guide end (Fig. 2a-5 and [0033]); wherein the first lumen and second lumens converge into the third lumen at the guide end (Fig. 2a-5 and [0033]); wherein a suture slot (see figure below) extends from the guide end to a position on the shaft (Fig. 12 and Col. 4 Lines 30-37).
Hoeppner teaches all the claimed limitations discussed above however, Hoeppner does not disclose a handle connected to the distal guide by the shaft where the first and second lumen extend through the shaft and handle.
Fortier discloses a handle (16) (Fig. 1 and 5-6) which is connected to the distal guide (14) by the shaft (12) (Fig. 1) where the first and second lumens extend through the shaft and the handle (Fig. 1).
It would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Hoeppner with the handle of Fortier, in order to facilitate the use of the device for various purposes and allow the easier interchangeability and closure of each opening (Col. 1 Lines 37-47).
Hoeppner in view of Fortier teaches all the claimed limitations discussed above however, Hoeppner in view of Fortier does not disclose that the guide end is angled relative to a longitudinal axis of the handle and shaft by an angle between about 15 and 45 degrees.
Karasic discloses discloses another well-known anchor delivery and drill device that can either use a shaft with an angled guide end (30) on shaft (20) (Fig. 2a-b and [0027-28]) and or a straight guide end (30) on shaft (22) (Fig. 2a-b and [0027-28]). Karasic further states that the guide end is angled relative to a longitudinal axis of the handle (26) and shaft (20) by an angle between about 15 and 45 degrees (Fig. 2a and [0028]).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the guide end of Hoeppner in view of Fortier to have an angle of 15 degrees, as taught by Karasic, 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).
Furthermore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Hoppner in view of Fortier with angled distal end in view of the teachings of Karasic, in order to direct passing instruments around anatomy during surgery, especially anatomy that prevents a straight trajectory ([0026]).
The combination of Hoeppner in view of Fortier and Karasic would have an angled guide end wherein the suture slot (see figure below) has the angle and extends from the guide end to a position on the shaft proximal of the angle ( see figure below where the slot extends proximal the guide end).
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Claim 2: Hoeppner further discloses a drill stem (124) terminating in a distal drill tip (distal end as seen in Fig. 1) is positioned in the first lumen (Fig. 5) such that the distal drill tip is extendable out of the first lumen, through the third lumen, and past the guide end (Fig. 5).
Claim 3: Hoeppner discloses wherein an anchor introducer (116) engageable to a suture anchor (30) at a distal end is positioned in the second lumen such that the suture anchor is extendable out of the second lumen, through the third lumen, and past the guide end (Fig. 6-7) .
Claim 6: Hoeppner discloses that the first lumen and the second lumen are stacked in a direction of the guide end angle (see figure below where they are stacked along the longitudinal axis).
Claim 7: Hoeppner discloses that the first lumen, the second lumen, and the third lumen each comprise a plurality of apertures (Fig. 4-7 where each have the distal opening where the lumen ends, the proximal opening where the lumen starts, and the second lumen has the opening at the side where 90 is located).
Response to Arguments
Applicant’s arguments filed on 7/27/26 have been considered but are moot in view of the new grounds of rejection.
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 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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