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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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, 4-5, 7, 15-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0336123 (Kumar) in view of US 2017/0238915 (Prior).
1. Kumar discloses a tissue closure device (instrument 10), the tissue closure device comprising:
an elongate body (body 12) having a longitudinal axis, a sidewall of the elongate body being provided with a suture receiving recess (apertures 42) extending from a proximal end to a distal end (see apertures 42 extending from a proximal end to a distal end in FIG. 3-4);
an operating portion (proximal end of body 12) disposed at the proximal end of the elongate body, the operating portion being provided with a proximal end engagement slot (proximal suture apertures 22) configured to clamp a suture (e.g., configured to clamp a suture with a greater dimension than the aperture 22)(FIG. 2; P0046);
a depth limiting mechanism comprising at least two wings (wings 50) disposed about the longitudinal axis (FIG. 1; P0037), a proximal end of each wing being pivotally connected to the distal end of the elongate body about a pivot that is perpendicular to the longitudinal axis to allow movement of the wing between a folded position (FIG. 6) and an unfolded position (FIG. 7)(P0051), wherein the at least two wings together form an extension section of the elongate body when the at least two wings are in the folded position (FIG. 6); and the at least two wings extend radially outward relative to the elongate body and together define a positioning plane at top surfaces of the at least two wings when the at least two wings are in the unfolded position (FIG. 7; P0051), and the depth limiting mechanism is provided with a distal end engagement slot (suture slot 52) for clamping the suture (FIG. 1; P0045), the distal end engagement slot being at least partially formed on the wing (FIG. 1; P0045),
wherein the tissue closure device is configured to allow the suture to be retained between the proximal end engagement slot and the distal end engagement slot and received in the suture receiving recess prior to entry of the tissue closure device into a tissue (FIG. 2), and to cause the suture to be stretched when the at least two wings are pivoted from the folded position to the unfolded position, so as to define a suture section that is at least partially parallel to the positioning plane and is configured to be gripped by an instrument (FIG. 7-8; P0052-P0054).
Kumar discloses the invention substantially as claimed as discussed above and further discloses the proximal end engagement slot (proximal suture apertures 22) but does not disclose the slot being a clamp configured to clamp a suture. Prior teaches a tissue closure device in the same field of endeavor having a clamp (e.g., actuator member 124 with apertures for looped end of suture 150 which can reasonably be considered a “clamp” since it is movably fastens the looped end of suture 150 to plunger 120 in FIG. 5A-5B) for the purpose of manually moving wings between the folded and unfolded positions by manipulating the clamp (FIG. 5A-5B; P0100). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal end engagement slot of Kumar to be a clamp in order to manually move wings between the folded and unfolded positions by manipulating the clamp.
2. The distal end engagement slot comprises a first distal end engagement slot (suture slot 52 on first wing 50; alternatively, needle slot 96) and a second distal end engagement slot (suture slot 52 on second wing 50), the first distal end engagement slot and the second distal end engagement slot being configured to enable (or at least capable of enabling) the suture to disengage from the first distal end engagement slot but remain engaged with the second distal end engagement slot when gripped by the instrument (see FIG. 9 where the portion of suture near end 81a has been is retracted such that it disengaged (or capable of being disengaged) from the first suture slot 52 but the second suture slot 52 remains engaged with the portion of suture near end 81b)(alternatively, see FIG. 9 where the portion of suture near end 81a has been is retracted such that it disengaged (or capable of being disengaged) from the needle slot 96 but the suture slot 52 remains engaged with the portion of suture near end 81b).
4. Both the first distal end engagement slot and the second distal end engagement slot are disposed on a wing of the at least two wings (FIG. 2).
5. The first distal end engagement slot is formed as a hook-shaped slot comprising an inclined slot extending distally and radially outward simultaneously (FIG. 2-3), the first distal end engagement slot having an inner dimension greater than a diameter of the suture (FIG. 2-3).
7. The first distal end engagement slot (needle slot 96) and the second distal end engagement slot (suture slot 52) are positioned such that the first distal end engagement slot is radially closer to the longitudinal axis than the second distal end engagement slot when the wing is in the unfolded position (FIG. 1).
15. Kumar discloses a tissue closure device (instrument 10), the tissue closure device comprising:
an elongate body (body 12) having a longitudinal axis, a sidewall of the elongate body being provided with a suture receiving recess (apertures 42) extending from a proximal end to a distal end (see apertures 42 extending from a proximal end to a distal end in FIG. 3-4);
an operating portion (proximal end of body 12) disposed at the proximal end of the elongate body, the operating portion being provided with a proximal end engagement slot (proximal suture apertures 22) configured to clamp a suture (e.g., configured to clamp a suture with a greater dimension than the aperture 22)(FIG. 2; P0046);
a depth limiting mechanism comprising at least two wings (wings 50) disposed about the longitudinal axis (FIG. 1; P0037), a proximal end of each wing being pivotally connected to the distal end of the elongate body about a pivot that is perpendicular to the longitudinal axis to allow movement of the wing between a folded position (FIG. 6) and an unfolded position (FIG. 7)(P0051), wherein the at least two wings together form an extension section of the elongate body when the at least two wings are in the folded position (FIG. 6); and the at least two wings extend radially outward relative to the elongate body and together define a positioning plane at top surfaces of the at least two wings when the at least two wings are in the unfolded position (FIG. 7; P0051), and the depth limiting mechanism is provided with a distal end engagement slot (suture slot 52) for clamping the suture (FIG. 1; P0045), the distal end engagement slot being at least partially formed on the wing (FIG. 1; P0045);
wherein the tissue closure device is configured to allow the suture to be retained between the proximal end engagement slot and the distal end engagement slot and received in the suture receiving recess prior to entry of the tissue closure device into a tissue (FIG. 2), and to cause the suture to be stretched when the at least two wings are pivoted from the folded position to the unfolded position, so as to define a suture section that is at least partially parallel to the positioning plane and is configured to be gripped by an instrument (FIG. 7-8; P0052-P0054).
Kumar discloses the invention substantially as claimed as discussed above and further discloses the wings transitioning from the folded position to the unfolded position (e.g., biased to the unfolded position at FIG. 6-7 and P0051) but does not disclose the operating portion being configured to transition the wings via the suture. Prior teaches a tissue closure device in the same field of endeavor having an operating portion (e.g., actuator member 124 with apertures for looped end of suture 150) configured to transition the wings from the folded position to the unfolded position (FIG. 5A-5B; P0095 and P0100) via the suture (e.g., at least through its looped securement to actuator member 124) for the purpose of manually moving wings between the folded and unfolded positions (FIG. 5A-5B; P0100) and as an equivalent to the wings being biased from the folded position to the unfolded position (P0100). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal end engagement slot of Kumar to be a clamp in order to manually move wings between the folded and unfolded positions and since Prior teaches manual transition and biased transition as being equivalents such that one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yields nothing more than predictable results to one of ordinary skill in the art (MPEP 2143).
16. The distal end engagement slot comprises a first distal end engagement slot (suture slot 52 on first wing 50; alternatively, needle slot 96) and a second distal end engagement slot (suture slot 52 on second wing 50), the first distal end engagement slot and the second distal end engagement slot being configured to enable (or at least capable of enabling) the suture to disengage from the first distal end engagement slot but remain engaged with the second distal end engagement slot when gripped by the instrument (see FIG. 9 where the portion of suture near end 81a has been is retracted such that it disengaged (or capable of being disengaged) from the first suture slot 52 but the second suture slot 52 remains engaged with the portion of suture near end 81b)(alternatively, see FIG. 9 where the portion of suture near end 81a has been is retracted such that it disengaged (or capable of being disengaged) from the needle slot 96 but the suture slot 52 remains engaged with the portion of suture near end 81b).
18. Both the first distal end engagement slot and the second distal end engagement slot are disposed on a wing of the at least two wings (FIG. 2).
19. Kumar discloses a tissue closure device (instrument 10), the tissue closure device comprising:
an elongate body (body 12) having a longitudinal axis, a sidewall of the elongate body being provided with a suture receiving recess (apertures 42) extending from a proximal end to a distal end (see apertures 42 extending from a proximal end to a distal end in FIG. 3-4);
an operating portion (proximal end of body 12) disposed at the proximal end of the elongate body, the operating portion being provided with a proximal end engagement slot (proximal suture apertures 22) configured to clamp a suture (e.g., configured to clamp a suture with a greater dimension than the aperture 22)(FIG. 2; P0046);
a depth limiting mechanism comprising at least two wings (wings 50) disposed about the longitudinal axis (FIG. 1; P0037), a proximal end of each wing being pivotally connected to the distal end of the elongate body about a pivot that is perpendicular to the longitudinal axis to allow movement of the wing between a folded position (FIG. 6) and an unfolded position (FIG. 7)(P0051), wherein the at least two wings together form an extension section of the elongate body when the at least two wings are in the folded position (FIG. 6); and the at least two wings extend radially outward relative to the elongate body and together define a positioning plane at top surfaces of the at least two wings when the at least two wings are in the unfolded position (FIG. 7; P0051), and the depth limiting mechanism is provided with a distal end engagement slot (suture slot 52) for clamping the suture (FIG. 1; P0045), the distal end engagement slot being at least partially formed on the wing (FIG. 1; P0045);
wherein the tissue closure device is configured to allow the suture to be retained between the proximal end engagement slot and the distal end engagement slot and received in the suture receiving recess prior to entry of the tissue closure device into a tissue (FIG. 2), and to cause the suture to be stretched when the at least two wings are pivoted from the folded position to the unfolded position, so as to define a suture section that is at least partially parallel to the positioning plane and is configured to be gripped by an instrument (FIG. 7-8; P0052-P0054).
Kumar discloses the invention substantially as claimed as discussed above but does not disclose the fixing block. Prior teaches a tissue closure device in the same field of endeavor having a fixing block (distal region 112b of shaft 110 in FIG. 1) for the purpose of providing the elongate body with a blunt tip (FIG. 5A; P0092). The fixing block (240) fixedly connected to the distal end of the elongate body and extending along the longitudinal axis (FIG. 2B). The fixing block being positioned such that the fixing block is located distal to a junction of the at least two wings when the at least two wings are in the unfolded position (FIG. 2B). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tissue closure device of Kumar to have a fixing block as taught by Prior in order to provide the elongate body with a blunt tip.
Allowable Subject Matter
Claims 3, 6, 8-14, 17, and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art of record does not disclose or suggest the combination of a rigid inner slot wall with an inner dimension greater than the suture and an elastic inner slot wall with an inner dimension less than the suture to form an interference fit at the distal engagement slots, as recited in claim 3.
The prior art of record does not disclose or suggest the combination of the wing being provided with a feature made of a flexible material and the second distal end engagement slot being formed in the feature, as recited in claim 6.
The specific relative opening directions and acute angular relationship, plus placement at the radially outer end of the wing, as recited in claim 8, are not taught or suggested by Kumar.
Response to Arguments
Applicant’s arguments regarding the new limitations with respect to Kumar have been considered but are moot because the arguments do not apply to the rejection in the previous office action (e.g., do not apply to claim limitations previously rejected). All arguments directed to new limitations in the amended claims are addressed in the rejection above.
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 TODD J SCHERBEL whose telephone number is (571)270-7085. The examiner can normally be reached Mon - Fri 9:00-6:00.
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, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
TJ SCHERBEL
Primary Examiner
Art Unit 3771
/TODD J SCHERBEL/Primary Examiner, Art Unit 3771