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 .
Response to Amendment
Claims 15-28 are pending in the application. Claims 1-14 and 29-34 have been canceled.
Election/Restrictions
Applicant’s election without traverse of claims 15-28 in the reply filed on 1/5/26 is acknowledged.
The Applicant has canceled nonelected claims 29-34.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/19/23 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 19 is objected to because of the following informalities: in line 2, “releasable” should read --releasably--. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: in line 1, “releasable” should read --releasably--. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: in line 2, “releasable” should read --releasably--. 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.
Claim 21 is 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 21 recites the limitation "the snare bight" in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 15-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Singhatat et al. (US 2010/0249809 A1) (“Singhatat”).
Regarding claim 15, Singhatat discloses (Figures 13A-13F, 16A-16J) a method of arthroscopically forming a repair loop around a tear (18) through a tissue (14) using a suture passer (10), the suture passer including a handle end (proximal end of device) and a distal working end (Figures 13A-13F) with a first jaw member (414), a second jaw member (410), and a tissue penetrator (430) the suture passer housing a primary suture (440) and a snare (434), the method comprising: passing a first end of the snare through the tissue from a first external surface of the tissue to a second external surface of the tissue (Figure 13A), on a first side of the tear (proximal side of tear); passing a bight (448) of the primary suture through the tissue from the first external surface of the tissue to the second external surface of the tissue, on a second side of the tear (distal side of tear); coupling the primary suture bight (448) to the snare first end and then withdrawing the snare to draw the primary suture bight (448) first through the tissue (14) on the first side of the tear and then through an opening (444) defined by the primary suture to form the repair loop. NOTE: in the specification, the Applicant defines “snare” may be a filament material, similar or identical to the suture material, or in some variations a different material (e.g., having a different composition and/or diameter and/or surface property). The snare may be configured so that it forms a loop or bight, and the loop cannot be opened as with the bight of suture that is passed. For example, the loop forming the snare may be closed at both ends, or at one end forming the loop (paragraph 0230). The shuttling element (434) disclosed by Singhatat is a different material than the suture material and forms a loop that cannot be opened, to allow the shuttling element to be coupled to the needle (paragraph 0091).
Regarding claim 16, Singhatat discloses (Figure 13A) that the snare first end is preloaded onto the tissue penetrator (430) within the second jaw member (410) and wherein passing the snare first end through the tissue (14) includes advancing the tissue penetrator through the tissue, loaded with the snare first end (Figure 13A, paragraph 0092).
Regarding claim 17, Singhatat discloses that after passing the snare first end, the tissue penetrator (430) is withdrawn into the second jaw member (410) to load the primary suture bight onto the tissue penetrator (paragraph 0092).
Regarding claim 18, Singhatat discloses (Figures 13F and 13G) tensioning the primary suture to cinch the primary suture opening (paragraph 0094).
Regarding claim 19, Singhatat discloses (Figures 13A and 13B) after passing the snare first end through the tissue, releasable holding the snare first end with the first jaw member (414), while the primary suture bight is passed (paragraph 0092).
Regarding claim 20, Singhatat discloses releasably holding the primary suture bight (448) with the first jaw member (414) after passing the primary suture bight (paragraph 0092).
Regarding claim 21, Singhatat discloses (Figure 13C) withdrawing the suture passer with the primary suture bight and the snare bight releasable held with the first jaw member (paragraph 0093).
Allowable Subject Matter
Claims 22-28 are allowed.
The following is an examiner’s statement of reasons for allowance: Claim 22 recites method of arthroscopically forming a repair loop around a tear through a tissue, using a suture passer including a handle end and a distal working end with a first jaw member, and a replaceable jaw cartridge including a second jaw member, a tissue penetrator, a primary suture and a snare, the method comprising:
engaging the replaceable jaw cartridge to the suture passer; and then
engaging the tissue on a first side of the tear with the first jaw member and the second jaw member, and while engaged passing an end of the snare through the tissue from the first jaw member to the second jaw member;
engaging the tissue on a second side of the tear with the first jaw member and the second jaw member, and while engaged on the second side, passing an end of the primary suture through the tissue from the first jaw to the second jaw; and
threading the primary suture end through the snare end and withdrawing the snare to draw the primary suture end first through the tissue on the first side of the tear and then through an opening defined by the primary suture to form the primary suture repair loop.
These structural features and method steps in combination are not disclosed or suggested in the prior art of record. The Singhatat reference fails to disclose or suggest a replaceable jaw cartridge including a second jaw member and engaging the replaceable jaw cartridge to the suture passer, and then performing the steps to form the primary suture repair loop.
Murillo et al. (US 2012/0283754 A1) disclose (Figures 1-62B) various suture passers and methods of arthroscopically forming a repair loop around a tear through a tissue, using a suture passer including a handle end and a distal working end with a first jaw member, and a replaceable jaw cartridge including a second jaw member, a tissue penetrator, as claimed. However, Murillo et al. fails to disclose or suggest the combination of steps recited for forming the repair loop.
Claims 23-28 are all dependent on claim 22, thus are also allowable over the prior art of record.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN D KNAUSS whose telephone number is (571)272-8641. The examiner can normally be reached M-F 12:30-8:30.
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771