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 .
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0009] on page 4 of the specification should be amended to the following: A protective cover can be provided for the flexible connector at a portion of the flexible connector comprising at least one selected from the group consisting of the intra-connector sliding loop engagement portion and the connector-device sliding loop engagement portion. The protective cover reduces friction and chafing.
Paragraph [0011] on page 5 of the specification should be amended to the following (delete comma before period): The implantable device can be a graft. The implantable medical device can be a second cleat comprising first and second holes. The connector- device engagement portion of the flexible connector can be threaded through one of the holes in a first direction and through the other of the holes in a second direction forming a sliding connector-device engagement. The implantable medical device can include a plate comprising first and second holes. The connector-device engagement portion of the flexible connector can be threaded through one of the holes in a first direction and through the other of the holes in a second direction forming a sliding connector-device engagement.
Paragraph [0076] on page 23 of the specification should be amended to the following: A recess or groove 243 is disposed between the proximate ends of aperture 234 and aperture 236. Groove 243 is generally concave, as viewed from the perspective of Fig. 2, and in certain embodiments, has edges that are chamfered or curved. As will be understood upon review of the further description below, apertures 234, 236, and groove 243 are sized to accommodate suture material for an adjustable cleat and suture combination.
Paragraph [0120] on page 37 of the specification should be amended to the following: As shown in Figs. 28-29, the tail 622 can be passed over the upward facing bend 639 to form a downward facing bend 642 that rests on the upward facing bend 639 with an ascending portion 648 and a descending portion 652. An upward facing bend 650 is thereby formed. The descending portion 652 is turned upward at a bend 658 to form an ascending portion 654. A portion 662 of the ascending portion 654 is captured longitudinally within a portion 661 of the portion 646 and enters at an aperture 666 and exits at an aperture 670.
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10,722,344 B2 (hereinafter “the ‘344 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are either anticipated by or an obvious variation of the claims of the ‘344 patent.
Claim Comparison:
Independent claim 1 of the instant application recites: An adjustable fixation device, comprising: a cleat comprising first and second cleat openings and a connector seat between the openings; a flexible connector having first and second cleat loops through the first and second openings of the cleat and a tensioning end portion, the connector comprising an intra-connector sliding loop engagement portion and a connector-device sliding loop engagement portion, the tensioning end portion of the flexible connector further comprising an axial sliding connector-connector engagement portion and a transverse sliding connector-connector engagement portion transversely engaging the first and second cleat loops and extending between portions of the cleat loops and the connector seat.
Claim 1 of the ‘344 patent recites: An adjustable fixation device, comprising: a cleat comprising first and second cleat openings and a connector seat between the openings; a flexible connector having first and second cleat loops through the first and second openings of the cleat and a tensioning end portion, the connector comprising an intra-connector sliding loop engagement portion where the first cleat loop slidably traverses the second cleat loop and a connector-device sliding loop engagement portion, the tensioning end portion of the flexible connector further comprising an axial sliding connector-connector engagement portion and a transverse sliding connector-connector engagement portion transversely engaging the first and second cleat loops and extending between portions of the first and second cleat loops and the connector seat.
The claims are nearly identical except that the instant claim 1 omits the specific functional limitation, “where the first cleat loop slidably traverses the second cleat loop.” This omission does not patentably distinguish the claims, as the structure and function are the same. One of ordinary skill in the art would have recognized the claimed device of the instant application as an obvious variation of, or fully encompassed by, the device claimed in the ‘344 patent.
Dependent claims 2-10 of the instant application are rejected for the same reasons, as they recite the same or obvious additional features (e.g., suture material, specific axial/transverse threading, tapered openings, lateral guide holes, protective cover) already present in or obvious over claims 2-10 of the ‘344 patent.
Independent claim 11 (system) and its dependents (12-18) are similarly rejected over claims 11-18 of the ‘344 patent. The additional limitations (e.g., implantable medical device being a graft, second cleat, or plate; 4:1 mechanical advantage) are identical to or obvious variations of the corresponding claims in the ‘344 patent.
Independent claim 19 (method) and its dependents (20-29) are rejected over claims 19-29 of the ‘344 patent for the same reasons. The recited steps of providing the device, positioning it in the body, and tensioning are coextensive with the method claimed in the ‘344 patent.
Claims 30-34 are also rejected on the ground of non-statutory double patenting. These claims recite minor variations in cleat hole geometry (symmetric hole and tapered hole), adjustable splice, sheath with tails, and explicit 4:1 mechanical advantage with loop/tail positioning. These features would have been obvious to one of ordinary skill in view of the claims of the ‘344 patent, which already describe and enable an adjustable suture-cleat construct with the same mechanical advantage and sliding loop engagements.
Claim Objections
Claims 3 and 21 are objected to because of the following informalities:
Claim 3 should be amended to the following, “The adjustable fixation device of claim 1, wherein the axial sliding connector-connector engagement portion comprises a portion of the tensioning end being positioned in an axial channel through a portion of a cleat loop.”
Claim 21 should be amended to the following, “The method of claim 19, wherein the axial sliding connector-connector engagement portion comprises a portion of the tensioning end being positioned in an axial channel through a portion of a cleat loop.”
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 1-29 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.
Claims 1, 11 and 19 recite the limitation "portions of the cleat loops." There is insufficient antecedent basis for this limitation in the claim. It is unclear if “portions of the cleat loops” refers to some portion of the first and/or second cleat loop, or portions of both the first and/or second cleat loops, or another portion of an additional cleat loop. Appropriate correction of clarification is required.
Claims 2-10 are rejected by virtue of their dependency on claim 1. Claims 12-18 are rejected by virtue of their dependency on claim 11. Claims 20-29 are rejected by virtue of their dependency on claim 19.
Claims 3 and 21 recite the limitation "a cleat loop." It is unclear if “a cleat loop” refers to the first cleat loop, the second cleat loop or an additional cleat loop. Appropriate correction of clarification is required.
Claim 4 is rejected by virtue of its dependency on claim 3. Claims 22-25 are rejected by virtue of their dependency on claim 21.
Claims 5 and 23 recite the limitation "a cleat loop." It is unclear if “a cleat loop” refers to the first cleat loop, the second cleat loop or an additional cleat loop. Appropriate correction of clarification is required.
Claims 6-7 are rejected by virtue of their dependency on claim 5. Claims 24-25 are rejected by virtue of their dependency on claim 23.
Claims 6 and 24 recite the limitation "a portion of a cleat loop." It is unclear if “a cleat loop” refers to the first cleat loop, the second cleat loop, the cleat loop as in claims 5 and 23, or an additional cleat loop. Appropriate correction of clarification is required.
Claim 7 is rejected by virtue of its dependency on claim 6. Claim 25 is rejected by virtue of its dependency on claim 24.
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.
Claim(s) 1-7, 10-12, 17-25, 28-29, 32-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller (US 2012/0109194 A1).
Regarding claims 1-2, 11-12, 19 and 20, Miller discloses, an adjustable fixation system and device (10, see Figs. 1-5, para [0020]) and also method for the adjustable fixation of an implantable device such as a graft (see para [0025]), comprising:
a cleat (12, Fig. 1) comprising first and second cleat openings (20, 22, Fig. 1, para [0020]) and a connector seat (24, Fig. 1) between the openings;
a flexible connector that is a suture (suture 30, para [0020]) having first and second cleat loops (A, B, see Fig. 4) through the first and second openings of the cleat and a tensioning end portion (36 and/or 38, Fig. 1), the connector comprising an intra-connector sliding loop engagement portion (see annotated Fig. 1 below; “loop engagement portion” has been interpreted according to the broadest reasonable interpretation as any part of the connector that forms the intra-connector sliding loop) and a connector-device sliding loop engagement portion (bottom loop portion at 31, see annotated Fig. 1; “loop engagement portion” has been interpreted according to the broadest reasonable interpretation as any part of the connector that forms the connector-device sliding loop), the tensioning end portion of the flexible connector further comprising an axial sliding connector-connector engagement portion (see annotated Fig. 1 below; axial portions of 36, 38 that extend along the axis shown by “L”) and a transverse sliding connector-connector engagement portion transversely engaging the first and second cleat loops and extending between portions of the cleat loops and the connector seat (see annotated Fig. 1 below; middle portion of suture engaging cleat at 24)
an implantable medical device that is a graft slidably connected to the adjustable fixation device at the connector-device sliding loop engagement portion (graft, see para [0021]; paras [0025]-[0026]).
Regarding claim 19, Miller discloses providing the device as stated above for claims 1 and 11, and also positioning the adjustable fixation device (10) and the implantable medical device (graft) in the body of the patient (para [0025]); applying a tensioning force to the tensioning end portion of the flexible connector to tighten and secure the adjustable fixation device and the implantable medical device in position in the body of the patient (paras [0025]-[0026]; also para [0021]).
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Regarding claims 3 and 21, Miller discloses the adjustable fixation device of claims 1 and method of claim 19, wherein the axial sliding connector-connector engagement portion comprises a portion of the tensioning end being positioned in an axial channel through a portion of a cleat loop (see Figs. 3-4, para [0020]; portion 32 is positioned through axial channel of 30).
Regarding claims 4 and 22, Miller discloses the adjustable fixation device of claim 3 and method of claim 21, wherein the axial channel is formed by axial threading of the tensioning end through the portion of the cleat loop (see Figs. 3-4; portion 32 is axial threaded through a portion of 30).
Regarding claims 5 and 23, Miller discloses the adjustable fixation device of claim 1 and method of claim 21, wherein the transverse sliding connector-connector engagement portion comprises a portion of the tensioning end being transversely threaded through a cleat loop (see Figs. 3-4, para [0020]).
Regarding claims 6 and 24, Miller discloses he adjustable fixation device of claim 5 and method of claim 23, wherein the transverse sliding connector-connector engagement portion comprises a portion of the tensioning end being positioned in a transverse channel through a portion of a cleat loop (see Figs. 3-4, para [0020]).
Regarding claims 7 and 25, Miller discloses the adjustable fixation device of claim 6 and method of claim 24, wherein the transverse channel is formed by transverse threading of the tensioning end through the connector-connector engagement portion of the cleat loop (see Figs. 3-4, para [0020]).
Regarding claims 10 and 17, Miller discloses the adjustable fixation device of claims 1 and 11, further comprising a protective cover (40, Fig. 1, para [0020]) for the flexible connector at a portion of the flexible connector comprising at least one selected from the group consisting of the intra-connector sliding loop engagement portion and the connector-device sliding loop engagement portion (see Fig. 1).
Regarding claims 18 and 29, Miller discloses the adjustable fixation system of claim 11 and method of claim 19, wherein the system provides a 4:1 mechanical advantage (see para [0021]; pulley-type characteristics provide a 4:1 advantage).
Regarding claim 28, Miller discloses the method of claim 19, wherein the method is applied to at least one selected from the group consisting of ligamentum teres repair, anterior cruciate ligament repair, and syndesmosis repair (see para [0025]; ACL repair).
Regarding claim 32, Miller discloses an adjustable fixation device (10, Figs. 1-5, paras [0020]-[0026]) comprises a cleat portion (12, Fig. 1) and a suture portion (30, Fig. 1), said suture portion including a suture tail (36, 38, Fig. 1), said suture tail being configured, when placed in tension, to tighten a loop of said suture portion so as to convey a mechanical advantage from said tail portion to said loop (see para [0021]; mechanical advantage of pulley type system).
Regarding claim 33, Miller discloses the adjustable fixation device of claim 32, wherein said mechanical advantage comprises a 4:1 mechanical advantage (see para [0021]; pulley-type characteristics provide a 4:1 advantage).
Regarding claim 34, Miller discloses the adjustable fixation device of claim 32, wherein said loop portion is disposed on a first side of said cleat portion (Fig. 1, para [0020) and said tail portion is disposed on a second opposite side of said cleat portion (Fig. 1, para [0020]), whereby said tail may be placed in tension after said cleat portion is installed to support a surgical graft with said loop portion (para [0025]).
Claim(s) 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Justin (US 2012/0065731 A1).
Regarding claim 30, Justin discloses, an adjustable fixation device (10, Figs. 10, loop 29 is adjustable, para [0145]) comprising:
a cleat (plate 11, Figs. 10, para [0145]), said cleat including a body member (body of plate 11, Fig. 10), said body member having an upper surface and a lower surface (upper and lower surfaces of plate 11, Fig. 10), said upper surface being disposed in substantially parallel spaced relation to said lower surface (Fig. 10, para [0145]), said cleat having disposed therethrough between said upper and lower surfaces a first symmetric hole (hole 14D, Figs. 10-11) and a second tapered hole (hole 14A, Figs. 10-11); and
a suture portion (line 24 is suture, Figs. 10-11, para [0130]), wherein a first region of said suture portion is disposed within said first symmetric hole and a second region of said suture portion is disposed within said tapered hole (portions 27/30 of 24 pass through hole 14D and portion 28 of 24 passes through hole 14A, Fig. 10), said suture being configured to include an adjustable splice (see further explanation and also paras [0130]; [0174]; [0145]). The language, "configured to include an adjustable splice," merely recites an intended use of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. "Configured to include an adjustable splice," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The Office submits that the device of Justin meets the structural limitations of the claim, and is capable of including an adjustable splice since suture line 24 is braided or woven as stated in para [0130] and therefore can be spliced, and also additional loops can be formed as stated in para [0174] such as adjustable loop 29 of suture 24, see Fig. 10, para [0145]).
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) 8-9, 15, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller, in view of Justin.
Regarding claims 8, 15 and 26, Miller discloses the adjustable fixation device of claims 1, 11 and 19, and that an additional hole can be placed on the cleat 12 for positioning (not shown, para [0020]; pulling-suture aperture), but does not expressly teach wherein the cleat further comprises lateral guide holes for receiving guiding sutures.
However, Justin, in the same field of art, namely adjustable fixation devices teaches a device having a cleat (plate 11, Figs. 1-7, 11, para [0145]), said cleat including a body member (body of plate 11, Fig. 1), said body member having an upper surface and a lower surface (upper and lower surfaces of plate 11, Fig. 1), said upper surface being disposed in substantially parallel spaced relation to said lower surface (Fig. 1, para [0145]), said cleat having disposed therethrough between said upper and lower surfaces a first hole (hole 14, Figs. 1-2) and a second hole (hole 14B, Figs. 1-2); and a suture portion (line 24 is suture, Figs. 1, 11, para [0130]), wherein a first region of said suture portion is disposed within said first symmetric hole and a second region of said suture portion is disposed within said tapered hole (portions 27/30 of 24 pass through hole 14D and portion 28 of 24 passes through hole 14A, Fig. 11). Justin further teaches wherein the cleat (11) further comprises lateral guide holes for receiving guiding sutures (additional holes 14c, 14d, Fig. 1, para [0127]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the cleat of Miller with the lateral guide holes as taught by Justin in order to provide the stated advantages of routing the suture through the cleat to position and enhance the locking of the suture to the treatment site (Justin, para [0127]).
Regarding claim 9, Miller discloses the adjustable fixation device of claim 1, and that the first and second cleat opening can have different shapes and/or sizes (para [0027]), but is silent as to wherein at least one of said first and second cleat openings is tapered.
However, Justin, in the same field of art, namely adjustable fixation devices teaches a device having a cleat (plate 11, Figs. 10, para [0145]), said cleat including a body member (body of plate 11, Fig. 10), said body member having an upper surface and a lower surface (upper and lower surfaces of plate 11, Fig. 10), said upper surface being disposed in substantially parallel spaced relation to said lower surface (Fig. 10, para [0145]), said cleat having disposed therethrough between said upper and lower surfaces a first symmetric hole (hole 14D, Figs. 10-11) and a second tapered hole (hole 14A, Figs. 10-11); and a suture portion (line 24 is suture, Figs. 10-11, para [0130]), wherein a first region of said suture portion is disposed within said first symmetric hole and a second region of said suture portion is disposed within said tapered hole (portions 27/30 of 24 pass through hole 14D and portion 28 of 24 passes through hole 14A, Fig. 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make at least one of the cleat opening of Miller with the tapered shape as taught by Justin in order to provide the stated advantages of enhancing the locking of the suture line as it is routed through the tapered shape and allow for additional loops or lines of suture to be inserted through the openings, which would enhance the mechanical advantage of the Miller system (Justin, para [0127] and Miller, para [0021]).
Claim(s) 13-14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller, in view of Albertorio (US 2010/0256677 A1).
Regarding claims 13-14, Miller discloses the adjustable fixation system of claim 11, but does not expressly teach wherein the implantable medical device is a second cleat or plate comprising first and second holes, and wherein the connector-device engagement portion of the flexible connector is threaded through one of the holes in a first direction and through the other of the holes in a second direction forming a sliding connector-device engagement.
However, Albertorio, in the same field of art, teaches an adjustable fixation system (100, Figs. 9-13) having a device with a cleat having first and second cleat openings (20, see Figs. 10-13) and a flexible connector/suture (2) that go through the first and second cleat openings, and an implantable medical device slidably connected to the adjustable fixation device by a sliding loop engagement portion (3) of the flexible connector (Figs. 9-13). Albertorio further teaches the implantable medical device is a second cleat or plate comprising first and second holes (20, Fig. 10, para [0051]), and wherein the sliding engagement portion of the flexible connector is threaded through one of the holes in a first direction and through the other of the holes in a second direction forming a sliding connector-device engagement (second loop 3, Figs. 10-13, para [0051]).
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 Miller implantable device to be the second plate or cleat as taught in Albertorio in order to provide the stated advantages of an integrated system that can be implanted as a single unit saving time for fixation of the system and creating overall stronger repair (see Albertorio, para [0055]).
Regarding claim 16, Miller discloses the adjustable fixation system of claim 11, but is silent as to further comprising a second adjustable fixation device having a second connector-device sliding loop engagement portion, the implantable medical device being slidably connected between the connector-device sliding loop engagement portion of the adjustable fixation device and the connector-device sliding loop engagement portion of the second adjustable fixation device.
However, Albertorio, as described above, teaches an adjustable fixation system (Figs. 9-13, para [0051]) that has a second adjustable fixation device (10, 20, Figs. 10-13) having a second connector-device sliding loop engagement portion (3), the implantable medical device (30) being slidably connected between the connector-device sliding loop engagement portion of the adjustable fixation device and the connector-device sliding loop engagement portion of the second adjustable fixation device (loops 3, see Fig. 10, para [0052]).
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 Miller implantable device to have a second adjustable fixation device as taught in Albertorio in order to provide the stated advantages of an integrated system that can be implanted as a single unit saving time for fixation of the system and creating overall stronger repair (see Albertorio, para [0055]).
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller, in view of Zajac (US 2012/0123474 A1).
Regarding claim 27, Miller discloses the method of claim 19, but does not expressly teach wherein the implantable medical device is a plate and the fixation is for syndesmosis repair.
However, Zajac, in the same field of art, teaches an adjustable suture-button construct (Abstract, see Figs. 16-32, paras [0076]-[0079]) that has a cleat or button with openings (button 20, Fig. 16) and a flexible connector/suture (30, 44a, 44b, Fig. 16) threaded through the openings to form loops (splices, portions at 30, Figs. 17-20) that engage an implantable medical device such as a plate (300, Figs. 28-29, para [0079]) and the fixation is for syndesmosis repair (paras [0076]-[0079]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the system of Miller with the implantable medical device that is a plate for syndesmosis repair as taught by Zajac in order to repair different areas of the body and increase the flexibility of the system (Zajac, para [0076]).
Claim(s) 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller, in view of Justin.
Regarding claim 30, Miller discloses an adjustable fixation device (10, see Figs. 1-5, para [0020]) comprising: a cleat (12, Fig. 1), said cleat including a body member (body of 12, Fig. 1), said body member having an upper surface and a lower surface (Fig. 1), said upper surface being disposed in substantially parallel spaced relation to said lower surface (Figs. 1-2), said cleat having disposed therethrough between said upper and lower surfaces a first hole (20) and a second hole (22); and a suture portion (30), wherein a first region of said suture portion is disposed within said first hole and a second region of said suture portion is disposed within said second hole (Fig. 1, para [0020]), said suture being configured to include an adjustable splice (para [0025]). The language, "configured to include an adjustable splice," merely recites an intended use of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. "Configured to include an adjustable splice," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The Office submits that the device of Miller meets the structural limitations of the claim, and is capable of including an adjustable splice since suture line 30 is braided or woven and therefore can be spliced, and also additional loops can be formed in the suture portion 30 as stated in para [0021].
Miller does not expressly teach that the first hole is symmetric and the second hole is tapered. However, Justin, in the same field of art, namely adjustable fixation devices teaches a device having a cleat (plate 11, Figs. 10, para [0145]), said cleat including a body member (body of plate 11, Fig. 10), said body member having an upper surface and a lower surface (upper and lower surfaces of plate 11, Fig. 10), said upper surface being disposed in substantially parallel spaced relation to said lower surface (Fig. 10, para [0145]), said cleat having disposed therethrough between said upper and lower surfaces a first symmetric hole (hole 14D, Figs. 10-11) and a second tapered hole (hole 14A, Figs. 10-11); and a suture portion (line 24 is suture, Figs. 10-11, para [0130]), wherein a first region of said suture portion is disposed within said first symmetric hole and a second region of said suture portion is disposed within said tapered hole (portions 27/30 of 24 pass through hole 14D and portion 28 of 24 passes through hole 14A, Fig. 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make at least one of the cleat opening of Miller with the tapered shape as taught by Justin in order to provide the stated advantages of enhancing the locking of the suture line as it is routed through the tapered shape and allow for additional loops or lines of suture to be inserted through the openings, which would enhance the mechanical advantage of the Miller system (Justin, para [0127] and Miller, para [0021]).
Regarding claim 31, Miller as modified discloses the adjustable fixation device of claim 30, wherein said suture portion further includes a loop portion (30, Fig. 1, para [0020]), said loop portion being disposed coaxially within a sheath (40), said sheath including first and second tails (end portions of 40, Fig. 1) for fixing a graft adjacent to said loop portion of said suture portion (para [0025]; implantable medical device such as graft can be fixed to portion at 40).
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Justin, in view of Miller.
Regarding claim 31, Justin discloses the adjustable fixation device of claim 30, wherein said suture portion further includes a loop portion (29, Fig. 1), but is silent as to said loop portion being disposed coaxially within a sheath, said sheath including first and second tails for fixing a graft adjacent to said loop portion of said suture portion.
However, Miller, in the same field of art, and as discussed above teaches wherein said suture portion further includes a loop portion (30, Fig. 1, para [0020]), said loop portion being disposed coaxially within a sheath (40), said sheath including first and second tails (end portions of 40, Fig. 1) for fixing a graft adjacent to said loop portion of said suture portion (para [0025]; implantable medical device such as graft can be fixed to portion at 40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the loop of Justin with a sheath as taught by Miller in order to provide the advantages of helping to anchor the implantable medical device in position (Miller, para [0020]).
Conclusion
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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