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 Arguments
Regarding the previous 112 (d) rejection of claim 9, the cancellation of claim 9 is acknowledged and the 112(d) rejection of claim 9 is withdrawn. The examiner notes that claims 10 and 11 are still rejected under 112(d) since the limitations are duplications of limitations previously recited in claim 8.
Applicant's arguments filed 1/21/2026 have been fully considered but they are not persuasive.
Applicant argues that neither Zajac and/or Bonutti or Lin singly or in combination teach or suggest the sleeve as claimed nor “the push rod for implanting and deploying the syndesmosis suture construct, wherein the push rod comprises a boss that limits a depth to which the push rod may be advanced into the sleeve wherein the push rode comprises an elongate member including a shaft extending from a distal end to a proximal gripping end; the gripping end of the push rod adapted for being grasped during operation of the insertion assembly” as required by Claim 8.
The examiner respectfully disagrees. As recited in the previous office action, Zajac discloses the syndesmosis suture construct as recited in claim 8, but fails to disclose a delivery device as recited in claim 8.
Bonutti teaches a medical anchor deliver device comprising a sleeve 94n for housing an anchor (therefore it is capable of housing a syndesmosis suture construct of Zajac). The sleeve 94n is a generally elongate hollow tube 200n that includes a longitudinal opening (interpreted as central longitudinal opening 204n extending from entrance opening 206n to exit opening 208n, see Fig. 31), wherein the longitudinal opening has a diameter suitable for receiving the anchor (see Figs. 34-36 of Bonutti) and therefore, is capable of receiving the syndesmosis suture construct of Zajax (another form of bone anchor) and a push rod 386 into the sleeve 94n (Figs. 34-35, para. 0273: “The two inner members 386 and 388 (FIGS. 32 and 33) are sequentially inserted into the passage 204n” of Bonutti). The push rod 386 of Bonutti is for implanting and deploying the anchor and therefore, is capable of receiving the syndesmosis suture construct of Zajax (another form of bone anchor) (see Figs. 34-36 of Bonutti). The push rod 386 comprises a boss 394 that limits a depth to which the push rod 386 may be advanced into the sleeve 94n (Fig. 36, para. 0281: “When the anchor 30n has been moved to a desired position relative to the anchor retainer 280n (FIG. 37), the stop surface 396 on the stop section 394 of the inner member 386 (FIG. 36) is in abutting engagement with the end surface 408 on the tubular member 94n”), wherein the push rod 386 comprises an elongate member 392 including a shaft extending form a distal end 393 to a proximal gripping end 394 (Fig. 32, para. 0275); the gripping end 394 of the push rod 386 adapted for being grasped during operation of the insertion assembly (Figs. 35-36 illustrate the push rod 386 being advanced distally. Para. 0275 teaches that the gripping end 394 of the push rod 386 is the handle section of the push rod and para. 0279, 0281 teaches that the push rod is advanced distally to position the anchor in the anchor retainer 280n. Therefore, the handle section i.e. gripping end 394 is adapted for being grasped during operation of the insertion assembly to advance the push rod distally). Therefore, Bonutti teaches the push rod as claimed in claim 8.
Bonutti further teaches that the sleeve 94n includes a slit 102n that extends along the length of the sleeve (Fig. 31, para. 0269) and states that in para. 0279 that “The leading end surface 393 on the anchor positioning push rod 386 pushes the anchor 30n toward the anchor retainer 280n at the leading end portion 242m of the tubular outer member 94n. The leading end portion of the anchor 30n applies force against and resiliently deflects a projection 304n in the anchor retainer 280n” to allow the anchor retainer 280n to “firmly grip the anchor” as state in para. 0281. However, Bonutti fails to explicitly teach that the slit is what allows the sleeve to radially constrict so as to hold the anchor and push rod in an assembled configuration.
Lin in the same field of endeavor of bone anchor delivery devices (para. 0033: “a device 10 made according to a first embodiment of the present invention is used to anchor a tissue to a bone”) teaches that it is known in the art for a sleeve to be elastic by nature (para. 0041) and that a slit 51 on a sleeve 50 to imparts further elastic characteristics such that the sleeve may be widened for separation or disassembly of the device (para. 0041: “the slit 51 can be forced to widen to enable the sleeve 50 to be separated”) or to constrict around the anchor (para. 0041: “The sleeve 50 is used to fit around the contracted implant 11”). Therefore, one of ordinary skill in the art would understand from the teachings of Lin that providing elastic characteristics to a sleeve comprising a slit would allow the sleeve to constrict around the syndesmosis suture construct during assembly and further provide an alternative way to disassembly the sleeve from the rest of device when not in use. The combination of Zajac, Bonutti, and Lin would result in the insertion assembly as claimed in claim 8.
Applicant argues that Lin is not in the same field of endeavor as the previous prior art or the instant application. Therefore, there would be no motivation to combine Lin with Zajac and/or Bonutti.
The examiner respectfully disagrees. In response to applicant's argument that the device of Lin is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, as stated above, Lin is in the same field of endeavor as the previous prior art because it is bone anchor delivery devices (see Figs. 5a-d; para. 0033: “a device 10 made according to a first embodiment of the present invention is used to anchor a tissue to a bone”, para. 0042: “ Thereafter, the contracted implant 11, the suturing threads 21, and the connection tube 41 of the injection device 40 are fitted into the sleeve 50, which is then inserted into the hole 61 of the bone tissue 60.”). This is analogous to Zajac which discloses a syndesmosis suture construct (a type of bone anchor) (see Figs. 17-20, para. 0076-0077 of Zajac) and Bonutti which teaches a bone anchor delivery device (para. 0066: “the inserter 20 may be used to position anchors 30 in preformed openings in hard body tissue, such as bone”). In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, there would be motivation to combine since they are all in the same field of endeavor of bone anchors and bone anchor delivery and the rejection of Zajac in view of Bonutti and Lin is maintained.
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12, line 1: “the distal end” should recite “the distal end of the push rod”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 10-11 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10 recites the limitation “wherein the slit allows the sleeve to radially constrict so as to hold the syndesmosis suture construct and the push rod in an assembled configuration suitable for implantation into the bone hole.” which is a mere duplication of the newly added limitation in lines 7-11 of claim 8.
Claim 11 recites the limitation “wherein the push rod comprises a generally elongate member including a shaft extending from a distal end to a proximal end gripped end” which is a mere duplication of the newly added limitation in lines 9-10 of claim 8.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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, 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Zajac et al. (US 20120123474) [hereinafter Zajac] in view of Bonutti (US 20060142799) and Lin et al. (US 20040220615) [hereinafter Lin].
Regarding claims 8 and 10-11, Zajac discloses an insertion assembly (Figs. 16-20, para. 0068, 0076), comprising:
a syndesmosis suture construct 100 (Fig. 16, para. 0068) comprising a proximal fixator 10 configured to be in contact with a first bone 80 of a patient (Figs. 16-20, para. 0076), and a distal fixator 20 configured to be in contact with a second bone of the patient (Figs. 16-20, para. 0076);
wherein a suture 30 is looped through the proximal fixator 10 and the distal fixator 20 (Fig. 16, para. 0041);
the suture 30 comprising a splice 44a that slidably rides on portions of the suture 30 extending between the proximal 10 and distal fixators 20 (Figs. 12, 16, para. 0061, 0067-0068) wherein the splice 44a is configured to slidably ride on portions segments extending between the proximal 10 and distal fixators 20 (Figs. 12, 16, para. 0061, 0067-0068);
wherein a diameter of the splice 44a is less than a diameter of a bone hole 88 (Figs. 17-20, para. 0076 discloses that the suture construct 100 which includes the splice 44a is passed through the bone hole 88. Therefore, the diameter of the splice is less than the diameter of the bone hole.); and
wherein opposite suture ends of the suture 30 extend from the proximal fixator 10 (Fig. 16, para. 0065) and facilitate placing the syndesmosis suture construct 100 into a cinched configuration (Figs. 17-20, para. 0076-0077).
Zajac further discloses a suture construct delivery system comprising a needle 85 with pull-through sutures 86, 87 for the purpose deploying the suture construct to through a bone hole Figs. 17-20, para. 0076).
However, Zajac fails to disclose the following:
a sleeve for housing the syndesmosis suture construct in an elongate configuration, the sleeve being a generally elongate hollow tube that includes at least a longitudinal opening and a slit that extend along the length of the sleeve wherein the longitudinal opening has a diameter suitable for receiving the syndesmosis suture construct and a push rod into the sleeve (see note below in regards to functional language) and further wherein the slit allows the sleeve to radially constrict so as to hold the syndesmosis suture construct and the push rod in the assembled configuration;
a push rod for implanting and deploying the syndesmosis suture construct, wherein the push rod comprises a boss that limits a depth to which the push rod may be advanced into the sleeve wherein the push rod comprises an elongate member including a shaft extending form a distal end to a proximal gripping end;
the gripping end of the push rod adapted for being grasped during operation of the insertion assembly;
the boss comprising an outermost exterior diameter larger than an outermost exterior diameter of the sleeve;
wherein the boss is disposed at a position along the push rod such that the distal fixator completely exits a distal end of the sleeve when the boss contacts a proximal end of the sleeve.
Bonutti in the same field of endeavor teaches a medical anchor delivery device 20n (Figs. 31-37, para. 0269) comprising a sleeve 94n for housing an anchor 30n in an elongate configuration (interpreted as a state where the fixator of the anchor apparatus is positioned vertical within the sleeve, see Figs. 13-14 which illustrate a fixator in an elongate configuration compared to Fig. 15), the sleeve 94n being a generally elongate hollow tube 200n that includes at least a longitudinal opening (interpreted as the central longitudinal opening extending from entrance opening 206n to exit opening 208n, Fig. 31 para. 0269) and a slit 102n that extend along the length of the sleeve (Fig. 31, para. 0269) wherein the longitudinal opening has a diameter suitable for receiving the syndesmosis suture construct (see note below in regards to functional language) and a push rod 386 into the sleeve 94n (Figs. 34-35, para. 0278-0279); a push rod 386 for implanting and deploying the anchor 30n (Figs. 32, 35-36, para. 0273), wherein the push rod 386 comprises a boss 394 that limits a depth to which the push rod 386 may be advanced into the sleeve 94n (Figs. 32, 36, para. 0275, 0281) wherein the push rod 386 comprises an elongate member 392 including a shaft extending form a distal end 393 to a proximal gripping end 394 (Fig. 32, para. 0275);
the gripping end 394 of the push rod 386 adapted for being grasped during operation of the insertion assembly (Figs. 35-36 illustrate the push rod 386 being advanced distally. Para. 0275 teaches that the gripping end 394 of the push rod 386 is the handle section of the push rod and para. 0279, 0281 teaches that the push rod is advanced distally to position the anchor in the anchor retainer 280n. Therefore, the handle section i.e. gripping end 394 is adapted for being grasped during operation of the insertion assembly to advance the push rod distally);
the boss 394 comprising an outermost exterior diameter larger than an outermost exterior diameter of the sleeve 94n (see Figs. 36 which illustrates the outermost exterior diameter of the boss 394 being larger than the outermost exterior diameter of an annular end surface 408 of sleeve 94n, para. 0281); wherein the boss 394 is disposed at a position along the push rod 386 such that the anchor 30n completely exits a distal end of the sleeve 94n when the boss 394 contacts a proximal end of the sleeve 94n (Figs. 36-37, para. 0273, 0281-0282).
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 delivery system in Zajac to include delivery system comprising the sleeve and push rod having the boss and shaft comprising the distal end and the gripping end of Bonutti in order to protect the suture construct during delivery of the device to the bone hole (Figs. 34-36, para. 0283 of Bonutti) and allow the user to facilitate moving the suture construct to a desired position relative to the push rod and sleeve before insertion (para. 0007, 0283, 0287 of Bonutti).
However, modified Zajac fails to disclose wherein the slit allows the sleeve to radially constrict so as to hold the syndesmosis suture construct and the push rod in the assembled configuration.
Lin in the same field of endeavor of implant delivery devices (Fig. 3, para. 0037) teaches that it is known in the art to construct a sleeve 50 comprising a slit 52 extending along a longitudinal direction of the sleeve 50 (Fig. 3, para. 0037) with elastic characteristics in order to allow the slit to expand enough to separate the sleeve from the rest of the device in the disassembled configuration, and thereby allow the slit of the sleeve to radially constrict so as to hold an implant 11 and a push rod 41 in an assembled configuration (Figs. 4a, 5b, para. 0037, 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 in modified Zajac to include the elastic characteristics, as taught by Lin, order to allow the user to disassemble the system via. expansion of the slit (para. 0041 of Lin), thereby providing an alternative way to assemble or disassemble the device.
Note: The limitation “wherein the longitudinal opening has a diameter suitable for receiving the syndesmosis suture construct and a push rod into the sleeve” is interpreted as functional language, not structural language. The examiner notes that the claims are directed towards an apparatus, not a method. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Since Bonutti teaches the structural component required i.e. the sleeve including the at least one longitudinal opening and the slit extending along the length of the sleeve for the functional limitation, modified Zajack thereby discloses the functional limitation of the longitudinal opening of the sleeve capable of having a diameter suitable for receiving the syndesmosis suture construct and a push rod into the sleeve. This functional language interpretation is supported by Figs. 34-36, para. 0278-0279 of Bonutti which teaches that the longitudinal opening of the sleeve is designed to have a diameter suitable for receiving an anchor and a push rod into the sleeve. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since, the device of Biel meets the structural limitations required in claim 1, the device of Biel also meets the functional limitation.
Regarding claim 12, Modified Zajac discloses wherein the distal end 393 comprises a blunt surface (see Fig. 32, para. 0275 of Bonutti) configured for causing the distal fixator of the syndesmosis suture construct to exit the sleeve when the push rod is advanced in a distal direction (Figs. 34-36, para. 0279 of Bonutti teaches that the distal end 393 of the push rod 386 is designed to cause the anchor 30n to exit the sleeve 94n when the push rod 386 is advanced in a distal direction; see note below).
Note: the limitation “configured for causing the distal fixator of the syndesmosis suture construct to exit the sleeve when the push rod is advanced in a distal direction” is interpreted as functional language. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Since Zajac in view of Bonutti discloses the structural component required i.e. a push rod comprising a distal end with a blunt surface, as taught by Bonutti, for the functional limitation, Modified Zajac thereby discloses the functional limitation of the claim. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since, the device of Modified Zajac meets the structural limitations required in claim 12, the device of Modified Zajac also meets the functional limitation.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
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