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 § 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.
Claim 59 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.
Claim 59 recites the limitation "the obturator" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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) 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,758,228 to Zenz-Olson et al. (Zenz-Olson) in view of US 2021/0402050 to Agnello et al. (Agnello).
Zenz-Olson teaches:
A method for delivering an implant to a targeted area in a subject, the method comprising:
coupling a bone fastener (100, Fig. 6) with an implant (50, Fig. 6) by passing the bone fastener therethrough;
inserting the bone fastener (100, Fig. 6) at least partially into a bone at the targeted area, thereby securing the implant to said bone (Fig. 6);
manipulating a portion of the implant not secured via the bone fastener so as to facilitate placement of said portion of the implant about a soft tissue of the targeted area (28, Fig. 6); and
securing said portion of the implant to the soft tissue by inserting one or more soft tissue fasteners (51, Fig. 6) through the implant and the soft tissue.
Zenz-Olson fails to teach:
The implant comprises a plurality of bioresorbable hyaluronan-based fibers and a plurality of non-resorbable fibers.
Agnello teaches:
Composite medical textile with non-resorbable fibers and bioresorbable hyaluronan-based fibers.
It would have been obvious to one of ordinary skill in the art at the time of the invention was filed to modify the mesh comprising a plurality of bioresorbable hyaluronan-based fibers and a plurality of non-resorbable fibers as taught by Agnello into Zenz-Olson in order to controlled rate of bioresorption, para. 0005.
Claim(s) 58-60, 65 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0059883 to Westling et al. (Westling) in view of US 2021/0275322 to Churchill et al. (Churchill) and further in view of US 5,405,360 to Tovey.
Westling teaches:
Claim 58: A method for delivering the implant to a targeted area, the method comprising: using a bone fastener tool (BFT) (144, Figs. 10A-10B), coupling a bone fastener (100, Fig. 10A) with an implant (50, Fig. 6) by passing the bone fastener therethrough; and
securing said portion of the implant to the soft tissue by inserting a soft tissue fastener (multiple staples, staples can secure to bone and soft tissue, Fig. 4) through the implant and the soft tissue.
Westling fails to teach:
Claim 58: aligning a cannula passage about the targeted area;
inserting the BFT through the cannula passage so as to insert the bone fastener at least partially into a bone at the targeted area, thereby securing the implant to said bone;
moving a slider from a retracted position to a deployed position, thereby causing a distal end of a pusher to move distally and radially so as to position a portion of the implant about a soft tissue at the targeted area.
Claim 59: aligning the cannula passage about the targeted area comprises using the obturator to facilitate insertion of the cannula within the subject.
Claim 60: the BFT retrieves the bone fastener from a caddy system by inserting one or more spikes through elongated shafts of the bone fastener.
Claim 65: the pusher positions the implant from a medial to lateral position about the targeted area.
Churchill teaches:
In the same field as endeavor, a device for delivering implant and fastener to patient’s shoulder, comprises a cannula (305, Fig. 3), an obturator (400, Fig. 3) about the targeted area (in order to deliver the implant);
the BFT retrieves the bone fastener (100, Fig. 8) from a caddy system (500, Fig. 16) by inserting one or more spikes (134A, 134B, Fig. 9) through elongated shafts (through passage ways 124A, Fig. 8, the portion having the passage ways 124A are considered elongated shaft) of the bone fastener (100, Fig. 8).
It would have been obvious to one of ordinary skill in the art at the time of the invention was filed to employ the cannula and obturator as taught by Churchill into Westling in order to facilitate inserting the bone fastener and implant by inserting the instrument through the cannula and obturator passage, as shown in Fig. 3 of Churchill, at least partially into a bone at the targeted area, thereby securing the implant to said bone.
Tovey teaches:
Resilient arm mesh deployer comprises a device (30, Fig. 1) comprises a slider (18, Fig. 1) from a retracted position (Fig. 3, retraction of the implant) to a deployed position (Fig. 2, deployment of the implant), thereby causing a distal end of a pusher (13 with arms 11, Fig. 2) to move distally and radially so as to position a portion of the implant about a soft tissue at the targeted area.
The pusher (13, with arms 11, Fig. 2) positions the implant (mesh 17, Fig. 5) from a medial to lateral position about the targeted area (since the mesh 17 is in contracted position within the delivery tube and being push out then expanded, the examiner’s position is that when the mesh first being pushed out, that’s the medial position, and when the mesh is expanded, that’s being toward the lateral position).
It would have been obvious to one of ordinary skill in the art at the time of the invention was filed to employ the implant delivery device as taught by Tovey into Westling in order to spread the implant over the tissues to be treated.
Claim(s) 62-63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Westling in view of Churchill and Tovey and further in view of US 10,758,228 to Zenz-Olson et al. (Zenz-Olson).
Westling in view of Churchill and Tovey teaches:
The method of claim 58 (see rejection of claim 58 above).
Westling in view of Churchill and Tovey fails to teach:
Inserting the soft tissue fastener through the implant and the soft tissue is via a soft fastener tool (SFT).
Inserting the SFT through the cannula passage for insertion of the soft tissue fastener.
Zenz-Olson teaches:
In the same field as endeavor, fastener delivery system and related methods, comprises Soft tissue fastener (51, Fig. 6) and bone fastener (100, Fig. 6).
Westling discloses a bone fastener tool but fails to disclose a soft tissue fastener tool. However, Zenz-Olson discloses this limitation. Hence, it is inherent that the soft tissue fastener 51 is being delivered by a soft tissue fastener tool. Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention was filed to employ the soft tissue fastener tool to deliver a soft tissue fastener as taught by Zenz-Olson into Westling in order to ease the impact force to soft tissue verse the impact of stapling a bone fastener into which would take a lot more force. Regarding claim 63, the soft tissue fastener tool would have been inserting through the cannula as taught by Churchill for insertion of the soft tissue fastener, see rejection of claim 58 above.
Allowable Subject Matter
Claim 61, 64 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 following is a statement of reasons for the indication of allowable subject matter: Regarding claim 61, none of the prior art disclose coupling the bone fastener with the implant comprises placing the implant on an implant recess on a caddy system prior to passing the bone fastener through the implant. The prior art Churchill discloses two different devices for inserting the implant and the fastener and the fastener only inserting through the implant after the implant inserted into the body. Churchill discloses a caddy system/stapler loader 500 but fails to disclose an implant recess on the caddy system. Regarding claim 64, none of the prior art disclose rotating a handle of the BFT so as to cause the pusher to sweep clockwise and/or counterclockwise to further facilitate positioning of the implant about the targeted area. The prior art Tovey discloses delivering of a mesh implant by pushing the implant connected to plurality of arms connected to the implant from retracted position to expanded position by pushing the arms distally and the arm radially expand. The arms in Tovey are not sweeping clockwise or counter clockwise.
Conclusion
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/PHONG SON H DANG/Primary Examiner, Art Unit 3771