DETAILED ACTION
Claims 1-20 are pending in this application.
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
Claim 3 is objected to because of the following informalities: in line 3 it reads “an adjustable perimeter” and should read as --the adjustable perimeter--, since claim 3 is dependent on claim 2 that recites “an adjustable perimeter” in line 5. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 11-12, 15-16, and 20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 11 recites “the first soft anchor and the second soft anchor are secured within or on a first tissue” in lines 1-2, and “the securing device is secured within a second tissue” in line 3. However, the limitations should be read as --the first soft anchor and the second soft anchor are configured to be secured within or on a first tissue—and --the securing device is configured to be secured within a second tissue--, respectively.
Claim 12 recites “the securing device is secured within a stepped tunnel formed within the second tissue” and should rather read as --the securing device is configured to be secured within a stepped tunnel formed within the second tissue--.
Claim 15 recites “the securing device is secured within a stepped tunnel formed within the second tissue” and should rather read as --the securing device is configured to be secured within a stepped tunnel formed within the second tissue--. Claim 16 is rejected due to its dependency on Claim 15.
Claim 20 recites “two soft suture anchors secured on a surface of a first tissue” in lines 1-2 and “a suture sheath knotlessly attached to the two suture anchors and secured within a stepped tunnel formed within the second tissue” in lines 3-4.
However, the limitations should be read as -- two soft suture anchors configured to be secured on a surface of a first tissue-- and --a suture sheath knotlessly attached to the two suture anchors and configured to be secured within a stepped tunnel formed within the second tissue--, respectively.
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.
Claims 1-2, 4-7, 9, 11-12, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stone et al., hereinafter “Stone” (U.S. Pub. No. 2016/0022261).
Regarding claim 1, Stone discloses a knotless, all-suture, surgical construct comprising:
a first soft anchor 150a (Figure 22; [0058]) knotlessly connected to a second soft anchor 150b by a flexible coupler 900 ([0047], [0059]-[0060]); and
a securing device (“retaining device 906”; [0058]) attached to the flexible coupler.
Regarding claim 2, Stone discloses the flexible coupler 900 passes at least once through a first tubular sheath of the first soft anchor 150a and at least once through a second tubular sheath of the second soft anchor 150b to form at least one closed, continuous, flexible loop 910 with an adjustable perimeter ([0058]-[0059]).
Regarding claim 4, Stone discloses the flexible coupler 900 enters the first tubular sheath (of 150a) at a first location 160 (Figure 22; [0058]), extends within the first tubular sheath and exits the first tubular sheath at a second location 162, wherein the second location is different from the first location (Id.).
Regarding claim 5, Stone discloses the flexible coupler 900 enters the second tubular sheath (of 150b) at a first location 160 (Id.), extends within the second tubular sheath and exits the second tubular sheath at a second location 162, wherein the second location is different from the first location (Id.).
Regarding claim 6, Stone discloses the flexible coupler 900 is spliced through itself at one or more locations 908 (Figure 22; [0059]).
Regarding claim 7, Stone discloses each of the first soft anchor 150a and the second soft anchor 150b is an all-suture anchor ([0058]; anchors may be made of braided or woven material), the flexible coupler is round suture (Id.; 900 can be tubular), and the securing device is a soft-body fixation device (Id.; 906 is part of flexible strand 900, and is a soft-body fixation in terms of being used in soft tissue repair [see abstract]).
Regarding claim 9, Stone discloses the construct consists essentially of suture ([0040], [0044], [0058]). It is noted that “consisting essentially of” will be construed as equivalent to “comprising”. See MPEP 2111.03. III.
Regarding claim 11, Stone discloses the first soft anchor 150a and the second soft anchor 150b are capable of being secured within or on a first tissue, and wherein the securing device 906 is capable of being secured within a second tissue (Figure 22). It is noted that “secured within” first or second tissue are interpreted as functional claim language, indicating that the claimed device need only be capable of being used in such a manner and the Office submits that the device of Stone meets the structural limitations of the claim, and is capable of being secured within first or second tissue as claimed.
Regarding claim 12, Stone discloses the securing device 906 is capable of being secured within a stepped tunnel formed within the second tissue (Id.). It is noted that “secured within a stepped tunnel” is interpreted as functional claim language, indicating that the claimed device need only be capable of being used in such a manner and the Office submits that the device of Stone meets the structural limitations of the claim, and is capable of being secured within a stepped tunnel within the second tissue.
Regarding claim 20, Stone discloses a surgical repair consisting essentially of two soft suture anchors 150a, 150b (Figure 22, [0040], [0058]) capable of being secured on a surface of a first tissue to be attached to a second tissue, and a suture sheath 900 ([0058]; 900 can be tubular or hollow form) knotlessly attached to the two soft suture anchors ([0059]) and capable of being secured within a stepped tunnel formed within the second tissue. It is noted that “consisting essentially of” will be construed as equivalent to “comprising”. See MPEP 2111.03. III. Furthermore, it is noted that “secured on a surface of a first tissue” and “secured within a stepped tunnel” are interpreted as functional claim language, indicating that the claimed device need only be capable of being used in such a manner and the Office submits that the device of Stone meets the structural limitations of the claim, and is capable of being secured on a surface of first tissue and within a stepped tunnel within a second tissue.
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.
Claims 3, 8, and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Stone (U.S. Pub. No. 2016/0022261) in view of Kaiser et al., hereinafter “Kaiser” (U.S. Pub. No. 2016/0242760).
Regarding claim 3, Stone discloses the claimed invention, as discussed above, including a securing device (“a small knot or other retaining device 906…formed adjacent a first end 902” of flexible coupler/suture 900; Figure 22, [0058]), except does not disclose the securing device being passed through and looped around the at least one closed, continuous, flexible loop with the adjustable perimeter.
In the same field of art, namely surgical constructs, Kaiser teaches a securing device (collapsible fabric tubes can be coupled to suture ends, such as fabric tube 74; Figures 16C-16D, [0056]-[0057]) attached to a flexible coupler (suture 22) including a closed, continuous, flexible loop 46 or 47 with an adjustable perimeter (via applied tension; Id.), and the securing device being passed through and looped around the closed, continuous, flexible loop (see Figure 16D; fabric tube 74 passes through and loops around the closed, continuous, flexible loops 46, 47 since 74 wraps around the suture 22 of the loops). Kaiser teaches the securing device maintains tension to lock a diameter configuration of the loop without the use of knots (Kaiser; [0061]) which may be very time consuming to tie (Kaiser; [0004]).
It would have been obvious to one of ordinary skill before the effective filing date to modify the securing device such that it is passed through and looped around the at least one closed, continuous, flexible loop with the adjustable perimeter, as taught by Kaiser, as an alternative securing device to the knot 906 in Stone that maintains tension and secures the end of the flexible coupler to the loop to lock first and second tissues securely together (Kaiser; [0057]).
Regarding claim 8, Stone as modified teaches the claimed invention, as discussed above, except for the securing device is a suture, suture tape, suture tube, or suture sheath. However, Kaiser teaches collapsible tube 74 is a fabric tube or sheath that can be made of resorbable material ([0056], [0060], [0080]), wherein Stone further teaches similar tubes 150 made of braided resorbable suture material ([0040]). Therefore, it would have been obvious to one of ordinary skill before the effective filing date to modify the securing device to be a suture tube or suture sheath, as taught by Stone, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use.
Regarding claim 13, Stone discloses a surgical assembly for tissue repairs, comprising:
a first fixation device 150a (Figure 22; [0058]) and a second fixation device 150b, each consisting essentially of suture ([0040], [0044], [0058; it is noted that “consisting essentially of” will be construed as equivalent to “comprising” - See MPEP 2111.03. III.);
a flexible coupler 900 ([0047], [0059]-[0060]) passed through the first fixation device and through the second fixation device (Id.), the flexible coupler forming in a knotless manner at least one splice (at 908; Figure 22; [0059]) and at least one continuous, adjustable, tensionable loop extending between the first fixation device and the second fixation device ([0047], [0059]-[0060); and
a securing device (“retaining device 906”; [0058]).
However, Stone does not disclose the securing device passed through and looped around the at least one continuous, adjustable, tensionable loop
In the same field of art, namely surgical constructs, Kaiser teaches a securing device (collapsible fabric tubes can be coupled to suture ends, such as fabric tube 74; Figures 16C-16D, [0056]-[0057]) attached to a flexible coupler (suture 22) including a continuous, adjustable, tensionable loop 46 or 47 with an adjustable perimeter (via applied tension; Id.), and the securing device being passed through and looped around the continuous, adjustable, tensionable loop (see Figure 16D; fabric tube 74 passes through and loops around continuous, adjustable, tensionable loops 46, 47 since 74 wraps around the suture 22 of the loops). Kaiser teaches the securing device maintains tension to lock a diameter configuration of the loop without the use of knots (Kaiser; [0061]) which may be very time consuming to tie (Kaiser; [0004]).
It would have been obvious to one of ordinary skill before the effective filing date to modify the securing device such that it is passed through and looped around the at least one continuous, adjustable, tensionable loop with the adjustable perimeter, as taught by Kaiser, as an alternative securing device to the knot 906 in Stone that maintains tension and secures the end of the flexible coupler to the loop to lock first and second tissues securely together (Kaiser; [0057]).
Regarding claim 14, Stone as modified teaches a delivery needle 102 (Stone; Figure 1, [0039]) for sequentially deploying the first fixation device 150a and the second fixation device 150b within a first tissue to be attached to a second tissue (Stone; [0005], Figure 9).
Regarding claim 15, Stone as modified teaches the securing device capable of being secured within a stepped tunnel formed within the second tissue. It is noted that “secured within a stepped tunnel” is interpreted as functional claim language, indicating that the claimed device need only be capable of being used in such a manner and the Office submits that the device of Stone as modified, as discussed above, meets the structural limitations of the claim, and is capable of being secured within a stepped tunnel within the second tissue.
Regarding claim 16, Stone as modified teaches when the flexible coupler is pulled, the securing device is capable of being pulled into the stepped tunnel and fixated therein. It is noted that “when the flexible coupler is pulled, the securing device is pulled into the stepped tunnel and fixated therein” is interpreted as functional claim language, indicating that the claimed device need only be capable of being used in such a manner and the Office submits that the device of Stone as modified, as discussed above, meets the structural limitations of the claim, and is capable of being pulled into the stepped tunnel and fixated therein as claimed.
Regarding claim 17, Stone as modified teaches each of the first fixation device 150a and the second fixation device 150b includes a tubular sheath with two open ends (Stone; as in Figures 1A, 22).
Regarding claims 18-19, Stone as modified teaches the tissue repair is rotator cuff repair (Stone; [0038]), AC joint repair (Id.), syndesmosis repair, Achilles tendon repair, patellar tendon repair, ACL/PCL reconstruction (Id.), hip and shoulder reconstruction, AC joint reconstruction (Id.), syndesmosis reconstruction, quad/patellar tendon rupture repair, plantar repair, or hallux-valgus repair, or wherein the tissue repair is plantar plate repair (Id.; it is noted that "wherein the tissue repair is…" constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner and the Office submits that the device meets the structural limitations of the claim, and is capable of the recited types of repairs).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Stone (U.S. Pub. No. 2016/0022261) in view of Saint et al., hereinafter “Saint” (U.S. Pub. No. 2009/0248071).
Regarding claim 10, Stone discloses the claimed invention, as discussed above, except for the flexible coupler consists essentially of elastic material. It is noted that “consisting essentially of” will be construed as equivalent to “comprising” - See MPEP 2111.03. III.
In the same field of art, namely surgical constructs, in [0186]-[0187], [0196], Saint teaches a flexible coupler consisting essentially of elastic material (elastic suture), which accommodates healing tissue while supporting tissue, prevents suture pull-out yet recovers to its initial length, thus providing a gradual and more effective remodeling of tissue over time.
It would have been obvious to one of ordinary skill before the effective filing date to modify the flexible coupler such that it consists essentially of elastic material, as taught by Saint, to maintain support of healing tissue (Id.) and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANE D YABUT whose telephone number is (571)272-6831. The examiner can normally be reached M-F 9am-5pm.
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/DIANE D YABUT/Primary Examiner, Art Unit 3771
