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 Objections
Claims 4, 16, 18, 34, 44 and 47 are objected to because of the following informalities:
In claim 4, line 3, the phrase “the substantially planar surface” should read “the at least one substantially planar surface”.
In claim 16, line 4, the phrase “with first sharp blade” should read “with the first sharp blade”.
In claim 18, line 5, the phrase “while the blade withdrawn” should read “while the blade is withdrawn”.
In claim 34, line 3, the phrase “to exposes” should read “to expose”.
In claim 34, line 3, the phrase “the blade” should read “the first sharp blade” to remain consistent in referring to the first sharp blade.
In claim 34, line 6, the phrase “the blade” should read “the first sharp blade” to remain consistent in referring to the first sharp blade.
In claim 34, line 7, there appears to be an unnecessary period between the terms “back” and “removing”.
In claim 44, line 7, the phrase “while the blade withdrawn” should read “while the blade is withdrawn”.
In claim 47, line 2, the phrase “in distal direction” should read “in a distal direction”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-3, 5, 18, 45-46 and 50 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 2, the claim recites “the first leg”. There is insufficient antecedent basis for this limitation in the claim, since a first leg has not specifically been introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the leg previously introduced.
Regarding claim 3, the claim recites “a pair of barbs”. It is unclear whether the phrase includes the barb previously introduced, or is introducing new, separate barbs. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to a pair of barbs distinct from the barb previously introduced.
Regarding claim 5, the claim recites “the first leg” in line 2. There is insufficient antecedent basis for this limitation in the claim, since a first leg has not specifically been introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the leg previously introduced.
Regarding claim 18, the claim recites “the close behind the base”. It is unclear what “the close” is referring to, since a close has not been previously introduced and doesn’t appear to be referring to a structure. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to an area behind the base.
Regarding claim 45, the claim recites “only the one leg” in lines 2-3. It is unclear whether the phrase is referring to the tapered leg previously introduced, the tapered leg having a single leg, or introducing a new, separate one leg. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the tapered leg having a single leg.
Regarding claim 46, the claim recites “beyond the distal tip of first leg of the attachment device”. It is unclear whether “first leg” is referring to the leg previously introduced, or introducing a new, separate first leg. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the leg previously introduced.
Regarding claim 50, the claim recites “pre-loaded attachment devices” in line 2. It is unclear whether the phrase includes the attachment device previously introduced, or is introducing new, separate pre-loaded attachment devices. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to include the attachment device previously introduced.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-3, 16-18, 24-25, 34, 41 and 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zenz-Olson (US 2017/0189014 A1).
Regarding claim 1, Zenz-Olson discloses (see abstract; paras. [0055]-[0127]; figs. 1-24) a surgical attachment device (fig. 1) comprising:
a leg (102a, para. [0056]; fig. 1) extending from a proximal portion (proximal end of first arm 102a) to a distal tip (distal end of 102a) that is shaped with a taper (tapered at distal end, figs. 1-2 and 4); and
a base (104) connected to the proximal portion of the leg (para. [0056]), the base extending substantially perpendicular to the leg (includes perpendicular portion, fig. 4), wherein the base comprises an open portion (portion of bridge 104 extending continuously upward of first cavity 128a considered to be an open portion, e.g., cavity 128a is considered to be closed and the portion of bridge 104 extending proximally of cavity 128a is considered to be open, fig. 4) adjacent the proximal portion of the leg (fig. 4), the open portion configured to allow a sharp blade to extend through the base and along a side of the leg (allows arms 608 to extend through cavity 128a of staple 100, considered to extend by way of bridge 104 along the side of 102a, para. [0123]; fig. 23).
Regarding claim 2, Zenz-Olson discloses the device of claim 1. Zenz-Olson further discloses wherein the leg comprises a barb (122b, para. [0059]; fig. 4) protruding from the first leg (fig. 4), wherein the barb does not overhang the open portion of the base (fig. 4).
Regarding claim 3, Zenz-Olson discloses the device of claim 2. Zenz-Olson further discloses further comprising a pair of barbs (includes 122a and 122c, para. [0059]) extending in opposed lateral directions from each other (fig. 4).
Regarding claim 1, Zenz-Olson discloses (see abstract; paras. [0055]-[0127]; figs. 1-24), under an alternative interpretation with respect to the attachment device, a surgical attachment device (fig. 16) comprising:
a leg (at least one position retention member 204, para. [0092]; fig. 16) extending from a proximal portion (proximal end of 204) to a distal tip (distal end of 204) that is shaped with a taper (depicted in fig. 16); and
a base (annotated fig. 16) connected to the proximal portion of the leg (fig. 16), the base extending substantially perpendicular to the leg (fig. 16), wherein the base comprises an open portion (open portion of base, fig. 16) adjacent the proximal portion of the leg (fig. 16), the open portion configured to allow a sharp blade to extend through the base and along a side of the leg (members 272 extend through 204, para. [0117]; figs. 17-18).
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Annotated Figure 16 of Zenz-Olson
Regarding claim 16, Zenz-Olson discloses a system (includes delivery device 200, fig. 10) for fixing soft tissue, the system comprising: a delivery tool (200, para. [0090]; fig. 10) with an elongated shaft (273 of 270, para. [0115]; fig. 17) extending from a handle (includes 271, secured into housing 207 of 201, paras. [0115]-[0116]); at least a first sharp blade (272) extending distally from a distal end of the elongated shaft (fig. 17); the attachment device of claim 1 (fig. 16) positioned on the first sharp blade (fig. 18), with first sharp blade extending through the open portion of the base (considered to extend through open portion of 204).
Regarding claim 17, Zenz-Olson discloses the system of claim 16. Zenz-Olson further discloses wherein the blade, shaft, and handle are attached together as a subunit with no moving parts (271, 273 and 272 considered to move as a unit and therefore have no moving parts relative to each other, which appears to be consistent with the instant spec., para. [0107] of the published application, paras. [0115]-[0116] of Zenz-Olson; fig. 17), the delivery tool further comprising a sleeve (cover 202, para. [0094]; fig. 10) slidably disposed over the shaft (capable of translating relative to sheath assembly 232, para. [0097]; figs. 10-18), wherein the sleeve comprises a conical tip (tip including leaflets 215, considered to resemble a cone as leaflets taper distally and therefore meet the limitation of a conical tip, para. [0099]; fig. 10) and a slit (formed between leaflets) into the conical tip, dividing the conical tip into two half covers (two leaflets 215, para. [0095]) that can bend away from each other (via hinge, para. [0098]).
Regarding claim 18, Zenz-Olson discloses the system of claim 17. Zenz-Olson further discloses wherein translating the sleeve to a proximal position on the delivery tool causes the conical tip to open (expands outward in radial direction as cover is retracted, para. [0098]) as the conical tip passes over the base of the attachment device and the close behind the base (extends proximal of 204, fig. 11), wherein after the shaft has been used to drive the attachment device through a graft and into soft tissue (depicted in figs. 18 and 20), the closed conical tip sitting behind the base can be used to apply counterpressure to the base while the blade withdrawn from the attachment device (leaflets may move to a position proximal of a distal portion of sheath 203, considered to sit behind member 204 and be capable of use for applying counterpressure, note the claim limitation recites method steps within an apparatus claim and is treated as a functional limitation, because an apparatus claim covers what a device is, not what it does, see MPEP 2114(II), para. [0097]).
Regarding claim 16, Zenz-Olson discloses, under an alternative interpretation with respect to the handle, a system (includes delivery device 200, fig. 10) for fixing soft tissue, the system comprising: a delivery tool (200, para. [0090]; fig. 10) with an elongated shaft (273 of 270, para. [0115]; fig. 17) extending from a handle (201, para. [0091]); at least a first sharp blade (272) extending distally from a distal end of the elongated shaft (fig. 17); the attachment device of claim 1 (fig. 16) positioned on the first sharp blade (fig. 18), with first sharp blade extending through the open portion of the base (considered to extend through open portion of 204).
Regarding claim 24, Zenz-Olson discloses the system of claim 16. Zenz-Olson further discloses wherein the delivery tool comprises a sleeve (cover 202, para. [0094]) disposed over the shaft (figs. 10-18), wherein the sleeve is slidable between a proximal and a distal position (para. [0097]), wherein when the sleeve is in the distal position, the sleeve covers the first sharp blade (considered to cover 272 when cover 202 encloses sheath assembly, para. [0097]).
Regarding claim 25, Zenz-Olson discloses the system of claim 24. Zenz-Olson further discloses wherein the sleeve has a conical tip (leaflets 215 taper distally, considered to resemble a cone and therefore meet the claim limitation of a conical tip, figs. 10-12).
Regarding claim 34, Zenz-Olson discloses a method of attaching a graft or ligament to soft tissue (paras. [0114]-[0126]), the method comprising: navigating the conical tip of a system of claim 25 through an incision (para. [0114]); retracting the sleeve to exposes the blade carrying the attachment device (cover retracts in proximal direction, para. [0114]); piercing a graft and the soft tissue with the first sharp blade and by that carrying the attachment device through the graft and into the tissue (implant 310, figs. 18 and 20); sliding the sleeve in a distal direction relative to the handle (translates/slides with retractor member 210, considered to slide/translate proximally and distally, paras. [0097] and [0106]) so that the conical tip will provide counter pressure to the base of the attachment device while the blade is being pulled out from the tissue by pulling the handle back (trigger squeezed to remove insert 270, cover is considered to provide a level of pressure to sheath 203 and therefore retention members 204 when retracted proximal of 204, note the claim language does not describe the distal end of the sleeve abutting the base of the attachment device, such that any pressure provided by the cover is considered to be capable of providing counter pressure when the device is in use, further note the claim language does not positively recite the counter pressure, and instead recites a future tense, such that the conical tip is capable of providing counter pressure as discussed above, para. [0121]); removing the delivery tool from the incision (para. [0125]).
Regarding claim 41, Zenz-Olson discloses (see abstract; paras. [0055]-[0127]; figs. 1-24) a system for fixing soft tissue (includes delivery device 200, fig. 10), the system comprising:
a delivery tool (200, para. [0090]; fig. 10) with an elongated shaft (273, para. [0115]; fig. 17) extending from a body (210);
a handle (207) and a trigger (216) extending from the body (figs. 10-15); a sharp blade (272) extending distally from a distal end of the elongated shaft (fig. 17);
an attachment device (fig. 16) disposed on the blade (fig. 18), the attachment device comprising a tapered leg (at least one position retention member 204, depicted as tapered, para. [0092]; fig. 16) extending from a proximal portion to a distal tip (fig. 16), and a base (annotated fig. 16) connected to the proximal portion of the leg (fig. 16), the base extending substantially perpendicular to the tapered leg (fig. 16), wherein the base comprises an open portion adjacent the proximal portion of the leg (open portion of base, fig. 16), wherein the sharp blade extends through the base and along a side of the tapered leg when the attachment device is positioned on the sharp blade (members 272 extend through 204, para. [0117]; figs. 17-18); and
a sleeve (cover 202, para. [0094]; fig. 10) extending from the body and covering the sharp blade and the attachment device (encloses sheath assembly, para. [0097]), wherein squeezing the trigger towards the handle (actuation member 216 rotated towards handle, considered to be squeezed when user’s hand placed on 207 to engage 216, figs. 14-15) pulls the sleeve in a proximal direction towards the handle (para. [0114]), exposing the sharp blade and the attachment device (pulls sleeve proximally to expose retention members 204, fig. 15).
Regarding claim 44, Zenz-Olson discloses the system of claim 41. Zenz-Olson further discloses wherein the sleeve comprises a conical tip (tip including leaflets 215, considered to resemble a cone as leaflets taper distally and therefore meet the limitation of a conical tip, para. [0099]; fig. 10) and a slit (formed between leaflets) into the conical tip (fig. 10), dividing the conical tip into two half covers (two leaflets 215, para. [0095]) that can bend away from each other (via hinge, para. [0098]), wherein translating the sleeve to a proximal position on the delivery tool causes the conical tip to open (expands outward in radial direction as cover is retracted, para. [0098]) as the conical tip passes over the base of the attachment device and to close behind the base (extends proximal of 204, considered to close to a degree to form around shaft 203, fig. 11), wherein after the shaft has been used to drive the attachment device through a graft and into soft tissue (depicted in figs. 18 and 20), the closed conical tip sitting behind the base can be used to apply counterpressure to the base while the blade withdrawn from the attachment device (leaflets may move to a position proximal of a distal portion of sheath 203, considered to sit behind member 204 and be capable of use for applying counterpressure, note the claim limitation recites method steps within an apparatus claim and is treated as a functional limitation, because an apparatus claim covers what a device is, not what it does, see MPEP 2114(II), para. [0097]).
Regarding claim 41, Zenz-Olson discloses, under an alternative interpretation with respect to the attachment device, (see abstract; paras. [0055]-[0127]; figs. 1-24) a system for fixing soft tissue (includes delivery device 200, fig. 10), the system comprising:
a delivery tool (200, para. [0090]; fig. 10) with an elongated shaft (602, para. [0123]; fig. 22) extending from a body (210);
a handle (207) and a trigger (216) extending from the body (figs. 10-15); a sharp blade (arms of insert 600, structured similarly to insert 270 and considered to have a degree of sharpness, para. [0123]) extending distally from a distal end of the elongated shaft (fig. 22);
an attachment device (fig. 1) disposed on the blade (para. [0123]), the attachment device comprising a tapered leg (102a, tapered at distal end, para. [0056]; fig. 1) extending from a proximal portion (proximal end of first arm 102a) to a distal tip (distal end of 102a), and a base (104) connected to the proximal portion of the leg (para. [0056]), the base extending substantially perpendicular to the tapered leg (includes perpendicular portion, fig. 4), wherein the base comprises an open portion (portion of bridge 104 extending continuously upward of first cavity 128a considered to be an open portion, e.g., cavity 128a is considered to be closed and the portion of bridge 104 extending proximally of cavity 128a is considered to be open, fig. 4) adjacent the proximal portion of the leg (fig. 4), wherein the sharp blade extends through the base and along a side of the tapered leg when the attachment device is positioned on the sharp blade (allows arms 608 to extend through cavity 128a of staple 100, considered to extend by way of bridge 104 along the side of 102a and therefore considered to be capable of allowing a sharp blade to extend similarly, para. [0123]; fig. 23); and
a sleeve (includes cover 202 and sheath 203, para. [0094]; fig. 10) extending from the body and covering the sharp blade and the attachment device (fig. 10), wherein squeezing the trigger towards the handle (actuation member 216 rotated towards handle, considered to be squeezed when user’s hand placed on 207 to engage 216, figs. 14-15) pulls the sleeve in a proximal direction towards the handle (para. [0114]), exposing the sharp blade and the attachment device (pulls sleeve proximally, considered to expose staples and arms, figs. 22-24).
Claim(s) 1 and 4-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reeser (US 2012/0029538 A1).
Regarding claim 1, Reeser discloses (see abstract; paras. [0028]-[0075]; figs. 1-14) a surgical attachment device (fig. 1) comprising:
a leg (120, para. [0028]; fig. 1) extending from a proximal portion (proximal end of 120) to a distal tip (includes anchoring element 130) that is shaped with a taper (fig. 1); and
a base (110) connected to the proximal portion of the leg (fig. 1), the base extending substantially perpendicular to the leg (fig. 1), wherein the base comprises an open portion (115, para. [0030], fig. 4) adjacent the proximal portion of the leg (fig. 4), the open portion configured to allow a sharp blade to extend through the base and along a side of the leg (configured for fastener to slide along indexer, considered to be configured to allow a sharp blade to extend through 115 similarly, para. [0030]; figs. 4 and 6).
Regarding claim 4, Reeser discloses the device of claim 1. Reeser further discloses wherein the leg has at least one substantially planar surface along a length of the leg (annotated fig. 3), wherein the open portion has an inward facing flat portion (inward-facing wall of 115, fig. 3), wherein the substantially planar surface and the flat portion define a continuous flat surface adjacent an open space that allows a flat blade to slide proximally and distally against the continuous flat surface (depicted as a continuous flat surface, considered to allow flat structures such as a flat blade to slide proximally and distally, figs. 1-4 and 6).
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Annotated Figure 3 of Reeser
Regarding claim 5, Reeser discloses the device of claim 4. Reeser further discloses further comprising one or more barbs (includes 131 and 132, para. [0033]; fig. 1) configured to allow the first leg to be pushed in a distal direction into soft tissue and to impede the first leg from being withdrawn in a proximal direction out of the soft tissue (due to shape of barbs, para. [0033]).
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.
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) 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Zenz-Olson in view of Nering (US 2010/0292715 A1).
Regarding claim 42, Zenz-Olson discloses the system of claim 41. However, Zenz-Olson fails to disclose wherein the trigger comprises gears engaged with a crank shaft hub that is connected to the sleeve via a connecting rod, whereby squeezing the trigger rotates the crank shaft hub, pulling the sleeve via the connecting rod to translate over, and uncover, the sharp blade.
Nering teaches (paras. [0150]-[0152]; fig. 2), in the same field of endeavor, a system for fixing soft tissue (abstract) comprising a trigger (114) comprising gears (134) engaged with a crank shaft hub (136) that is connected to the instrument via a connecting rod (yoke 142), whereby squeezing the trigger rotates the crank shaft hub (paras. [0151]-[0152]), for the purpose of providing a mechanism for proximal and distal movement of the firing system (para. [0152]).
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 actuation member mechanism for the sleeve to include gears as claimed, in order to provide incremental proximal and distal movement of the sleeve when desired, based on the suggestions and teachings of Nering (para. [0152]).
Zenz-Olson (as modified) further teaches the crank shaft hub connected to the sleeve via a connecting rod (combination considered to further teach gears and yoke of actuation member of Zenz-Olson which is connected to cover 202), whereby squeezing the trigger rotates the crank shaft hub, pulling the sleeve via the connecting rod to translate over, and uncover, the sharp blade (combination considered to further teach squeezing of actuation member 216 of Zenz-Olson engaging gears and yoke such that sleeve is pulled proximally).
Regarding claim 43, Zenz-Olson (as modified) teaches the system of claim 42. Zenz-Olson (as modified) further teaches wherein the crank shaft hub is engaged with a ratchet mechanism (teeth of yoke 142 of Nering), and wherein squeezing the trigger a second time pushes the sleeve via the connecting rod to cover the sharp blade (combination considered to further teach proximal and distal movement of cover 202 via gears and yoke such that cover 202 is pushed).
Claim(s) 45 is rejected under 35 U.S.C. 103 as being unpatentable over Zenz-Olson in view of Krasniak (US 2023/0181186 A1).
Regarding claim 45, Zenz-Olson discloses the system of claim 41.
Zenz-Olson further discloses wherein the attachment device has only the one leg (single member 204 referenced such that attachment device is considered to include only the single member 204, see 112(b) rejection above).
However, Zenz-Olson fails to disclose wherein the attachment device includes at least two laterally opposed barbs pointing outward.
Krasniak teaches (para. [0109]), in the same field of endeavor, a system for fixing soft tissue (abstract) comprising an attachment device (300) including at least two laterally opposed barbs pointing outward (302a and 302b, considered to point outward in opposite directions), for the purpose of holding the anchor member within the bone as the piercing tip is extracted (para. [0109]).
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 position retention member of Zenz-Olson to include barbs as claimed, in order to hold the member within the tissue as other structures are extracted when desired, based on the teachings of Krasniak (para. [0109]).
Claim(s) 46 is rejected under 35 U.S.C. 103 as being unpatentable over Zenz-Olson in view of Gonzales (US 2009/0099577 A1).
Regarding claim 46, Zenz-Olson discloses the system of claim 41.
Zenz-Olson further discloses wherein the sharpened piercing tip of the sharp blade extends distally beyond the distal tip of first leg of the attachment device (fig. 18), and the sharp blade having various different shapes (para. [0115]).
However, Zenz-Olson fails to disclose wherein the sharp blade comprises a substantially flat piece with opposed first and second surfaces extending distally to a sharpened piercing tip.
Gonzales teaches (para. [0068]; figs. 45-46), in the same field of endeavor, a system for fixing soft tissue (abstract) comprising a sharp blade (ribbon 310) comprising a substantially flat piece with opposed first and second surfaces extending distally to a sharpened piercing tip (figs. 45-46), for the purpose of keeping the implant from moving side to side and restricting movement in one direction (para. [0068]).
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 shape of the sharp blade of Zenz-Olson to be a substantially flat piece extending distally to a sharpened piercing tip as claimed, in order to restrict movement in one direction of the position retention members 204 and provide a stable, straight position via the flat surface when desired, based on the suggestions and teachings of Gonzales (para. [0068]).
Claim(s) 47 and 49-50 are rejected under 35 U.S.C. 103 as being unpatentable over Zenz-Olson in view of Levy (US 2014/0257339 A1).
Regarding claim 47, Zenz-Olson, under the alternative interpretation with respect to the attachment device, discloses the system of claim 41.
However, Zenz-Olson fails to disclose wherein the sleeve includes a static comb with one or more steps that can push the attachment device in distal direction, wherein the static comb pushes the attachment device into tissue during surgery.
Levy teaches (para. [0041]), in the same field of endeavor, a system for fixing soft tissue comprising a static comb (hold comb) with one or more steps (depicted in fig. 5) that can push fasteners in a distal direction, wherein the static comb pushes the fasteners into tissue during surgery (considered to push fasteners in a distal direction via prevention of backward or downward movement, which appears to be consistent with the instant spec.), for the purpose of providing the capability of deploying a plurality of fasteners (para. [0031]).
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 sleeve of Zenz-Olson to further include a static comb as claimed, in order to provide the capability of deploying a plurality of fasteners when desired, to secure multiple locations of the implant to tissue with a single device, based on the teachings of Levy (paras. [0031] and [0038]).
Regarding claim 49, Zenz-Olson (as modified) teaches the system of claim 47. Zenz-Olson (as modified) further teaches wherein the static comb is in a fixed position with respect to the elongated shaft, and wherein the sleeve translates with respect to the static comb (combination considered to further teach static comb in a fixed position relative to the sleeve to prevent backwards/downward movement of the staples).
Regarding claim 50, Zenz-Olson (as modified) teaches the system of claim 49.
However, Zenz-Olson (as modified) fails to teach further comprising a dynamic comb fixed to the sleeve, wherein the dynamic comb pushes pre-loaded attachment devices in a distal direction down the sharp blade to position a subsequent device in position for delivery.
Levy teaches (paras. [0041] and [0043]), in the same field of endeavor, a system for fixing soft tissue (abstract) comprising a dynamic comb (957), wherein the dynamic comb pushes pre-loaded attachment devices in a distal direction to position a subsequent device in position for delivery (para. [0041]), for the purpose of pushing the fastener stack forward to drive the fasteners into tissue (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 sleeve of Zenz-Olson (as modified) to further include a dynamic comb, in order to push the staples forward to deploy a plurality of staples when desired, based on the suggestions and teachings of Levy (para. [0041]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/BRIGID K BYRD/Examiner, Art Unit 3771
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