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
According to the amendment filed August 25, 2026, claims 1-2, 7 and 9 have been amended, and new claim 21 has been added. Claims 1-17 and 19-21 are currently pending in this application, where claims 11-17 remain withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-10 and 19-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 2 is objected to because of the following informalities: at line 2, the comma between the words “comprising” and “sliding” should be deleted.
Appropriate correction is required.
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.
Claims 1-10 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Lamm (US 2020/0015865 A1) in view of Muller (US 2019/0125418).
Regarding claim 1, Lamm discloses method for correcting a bunion formed at a joint between a metatarsal and a great toe (shown in Figs. 4-12; described in at least para. 0006), the method comprising:
making an incision along a side of the metatarsal (para. 0056 describes making a small incision in the metatarsal at the medial side of the bunion);
resecting the metatarsal into a proximal metatarsal portion and a separate distal metatarsal portion, the proximal metatarsal portion having a distal-facing surface created by the resecting (para. 0060 describes resecting the metatarsal into proximal metatarsal portion 2a and distal metatarsal portion 2b, the proximal portion 2a having distal-facing surface 2c created by the resecting, as shown in Figs. 8-9);
implanting an implant through the incision into the distal-facing surface of the proximal metatarsal portion such that a head of the implant remains distal of the distal facing surface (as shown in Figs. 10 and 12, described in para. 0062, the implant nail 102 “is inserted through the incision and anchored into the prepared proximal metatarsal portion 2a” by driving the implant into the distal-facing surface 2c identified in Fig. 9), the implant (102; Figs. 1A-3C and 10-12; para. 0049) comprising a monolithic body (recited in para. 0049) having the head (120; Figs. 1A-B) and an anchor (122; Figs. 1A-B);
aligning a first aperture of the head of the implant with the distal metatarsal portion (first aperture 130 of head 120 of implant 102 is aligned with distal metatarsal portion 2b, as shown; Figs. 1A-3C and 10-12; para. 0051);
inserting a first fastener (104; Figs. 1A-2, 12; para. 0051) through the first aperture (130; Figs. 1A-2, 12) and into the distal metatarsal portion (2b; Fig. 2).
Lamm also discloses inserting a k-wire into the second metatarsal portion (shown in Figs. 5-6, inserting a k-wire 162 into second metatarsal portion 2b; para. 0056).
Lamm does not specifically disclose the steps of: (I) adjusting an alignment between the first and second metatarsal portions, (II) inserting a k-wire into the second metatarsal portion through the first aperture, and (III) inserting a second fastener through a second aperture of the head and into the proximal metatarsal portion that underlies the second aperture, wherein the first and second apertures are both located distal of the distal-facing surface and are aligned with each other with respect to the proximal-distal direction.
Regarding limitations (I) and (II), Muller is directed towards a method for correcting a bunion formed at a joint between a metatarsal and a great toe (see implant 100 in Figs. 1-3, having an extramedullary head portion 130 and intramedullary anchor portion 110, for use as shown in Fig. 12B for correcting a hallux valgus deformity, i.e. a bunion; para. 009346-0048), where the method includes the steps of implanting an implant having a head and an anchor through a distal-facing surface of a first metatarsal portion, adjusting an alignment between the first and second metatarsal portions (see Fig. 12A and para. 0069, which describes rotating the implant 100 to properly align distal bone section 412 with proximal section 410 of the cut/resected metatarsal by inserting a k-wire 251 through body 240 into distal second metatarsal portion 412; also see Fig. 12B), aligning a first aperture of the head of the implant with the second metatarsal portion (as shown in Fig. 12B, first aperture in head 130 is aligned with second metatarsal portion 412, the first aperture defined by distal fastener aperture 134 identified in Figs. 1-3; para. 0059, 0057), and inserting a k-wire into the second metatarsal portion through the first aperture (as shown in Fig. 12B and the flow chart of Fig. 12C, after inserting the implant 100 in an opening of proximal metatarsal portion 410 at step 1210, a distal k-wire is inserted through the body 240 of the guide into the distal metatarsal portion 412 at step 1212, the k-wire thus inserted through the first aperture 134 in the head 130).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the Muller’s steps of inserting a k-wire into the second metatarsal portion through the first aperture (of Lamm’s implant head) and adjusting alignment between the metatarsal portions, because Muller teaches these steps as appropriate for correcting a bunion deformity, where it is understood that such steps may aid in properly aligning the resected metatarsal portions to correct the deformity (see Muller, Figs. 12A-C and para. 0069) and inserting the k-wire through the first aperture in the implant allows a cannulated screw to be passed over the k-wire for insertion through the aperture (see Muller, Fig. 13, para. 0088 and claim 24).
Regarding limitation (III) above, Miller discloses an implant for use in the method described above (see implant 1400 in Figs. 17-19, described in para. 0092-0098), wherein the head (extramedullary portion 1432; Figs. 17-19; para. 0093) of the implant includes a first aperture and a second aperture (apertures 1434a, 1434b; Figs. 18-19; para. 0093), the apertures being aligned with each other with respect to a proximal-distal direction of the implant (aligned along axis 1420, as shown; Fig. 18), and each aperture configured to receive a fastener (see para. 0092).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lamm’s implant head to take the form of Muller’s as described above, where the head is an extramedullary portion that comprises first and second apertures for receiving fasteners, so that the method would necessarily include inserting a second fastener through the second aperture of the head and the first and second apertures are both located distal of the distal facing surface (noting that the extramedullary head portion described by Muller remains distal of the distal-facing surface, as shown in Fig. 13 of Muller), because Muller recognizes that the “addition of a second distal screw offers an additional point of fixation for sever hallux valgus or in the case of poor bone quality” (see para. 0089 of Muller).
Regarding claim 2, the combined teachings of Lamm and Muller disclose the method of claim 1.
Lamm also teaches wherein the first fastener is a screw (see screw 104; Fig. 12; para. 0053) inserted into the distal metatarsal portion (2b; Fig. 12) through the first aperture (130, as shown in Fig. 12 and described in para. 0064).
In the combination described above, the cited references do not specifically disclose wherein the screw is a cannulated screw and the method comprises sliding the cannulated screw over the k-wire and inserting the cannulated screw into the second metatarsal portion through the first aperture.
However, Muller discloses sliding a cannulated screw over the k-wire inserted into the second metatarsal portion through the first aperture in the head of the implant and inserting the cannulated screw into the second metatarsal portion through the first aperture (screw 452, shown inserted through opening in head 130 of implant 100, may be a cannulated screw, described in para. 0087-0088, and claim 24 describes that inserting the cannulated screw comprises inserting a k-wire at the proper location and sliding the cannulated screw over the k-wire; Fig. 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed Lamm’s first fastener/screw with a cannula, so that the screw is inserted through the implant’s first opening into the second metatarsal portion by sliding the screw over the k-wire placed in the second metatarsal portion, as suggested by Muller, because inserting a screw in such a manner is a known technique in the art for guiding and properly orienting the fastener for insertion, as recognized by Muller (see Muller, Fig. 13, para. 0087-0088 and claim 22).
Regarding claim 3, the combined teachings of Lamm and Muller disclose the method of claim 2, further comprising pre-drilling a cavity in the second metatarsal portion, the cavity configured to receive the cannulated screw (Lamm teaches using a reamer 192 to drill a cavity in second metatarsal portion 2b, shown in Fig. 13E and described in para. 0058, the cavity configured to receive Lamm’s screw 104 modified in view of Muller to be a cannulated screw, as described above with respect to claim 2).
Regarding claim 4, the combined teachings of Lamm and Muller disclose the method of claim 3.
In the combination, the above-cited references do not teach wherein the cavity is formed using a cannulated instrument aligned along the k-wire.
Muller discloses using a cannulated drill aligned along a k-wire to drill a hole into the second metatarsal section (see Figs. 12B-C and 13, where a cannulated drill 250 for drilling a hole 451 into the second metatarsal portion 412, i.e. at step 1214 in Fig. 12C, while the k-wire is still in place so that the cannulated drill is aligned with the k-wire; para. 0071 and 0081).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed Lamm’s cavity in the second metatarsal section using the cannulated drill aligned along the k-wire, as suggested by Muller, because aligning a cannulated drill over a k-wire is a known technique in the art for guiding such an instrument and forming the cavity at the proper location and orientation, as recognized by Muller.
Regarding claim 5, the combined teachings of Lamm and Muller disclose the method of claim 1, wherein the second fastener is a screw and the second aperture of the implant head attaches to the implant head to the proximal metatarsal portion (as described above with respect to claim 1, Lamm’s implant head is modified to include Muller’s second aperture, shown in Figs. 17-19, the second fastener/screw inserted through the second aperture attaches Lamm’s modified implant head to the proximal metatarsal portion).
Regarding claim 6, the combined teachings of Lamm and Muller disclose the method of claim 1, and Lamm discloses the method further comprising securing a length of suture to the great toe, tensioning the suture to re-align the great toe relative to the first metatarsal portion, and attaching the length of suture to the implant head (see Lamm, Figs. 11A-12 and para. 0063, illustrating securing a length of suture 250 to the great toe 6, tensioning the suture to align great toe 6 relative to first metatarsal portion 2a, and attaching the suture 250 to implant 102 at the head thereof).
Regarding claim 7, the combined teachings of Lamm and Muller disclose the method of claim 1, and Lamm discloses the method further comprising translating the second metatarsal portion to expose the distal-facing surface on the first metatarsal portion (see Lamm, Fig. 9 and para. 0061, teaching translating the second metatarsal portion 2b laterally relative to the first metatarsal portion 2a to expose distal-facing surface 2c of the first metatarsal portion 2a).
Regarding claim 8, the combined teachings of Lamm and Muller disclose the method of claim 1, wherein inserting the k-wire into the second metatarsal is performed with the joint in a corrected alignment (where Lamm’s method is modified to include Muller’s step of aligning the first and second metatarsal portions, the k-wire inserted into the second metatarsal portion as described above, into the aperture in the head of Lamm’s implant, the k-wire is inserted with the joint in a corrected alignment).
Regarding claim 9, the combined teachings of Lamm and Muller disclose the method of claim 8, wherein the k-wire is inserted in a centered position relative to the aperture (where Lamm’s method has been modified so that inserting the fastener 104 into aperture 130 in the implant head includes Muller’s step of inserting a k-wire through the aperture and inserting the fastener over the k-wire, and where Muller teaches in para. 0049 that the k-wire can be positioned in the same location as the fastener in the corresponding bone section, the k-wire is understood to be inserted in a centered position relative to the aperture, i.e. the same location as the fastener).
Regarding claim 10, the combined teachings of Lamm and Muller disclose the method of claim 1, wherein the k-wire is configured to control movement of the second metatarsal portion in a frontal plane (Lamm’s k-wire 162, shown in Figs. 5-6 inserted into second metatarsal portion 2b, is understood to be capable for controlling movement of the second metatarsal portion 2b in a frontal plane).
Regarding claim 19, the combined teachings of Lamm and Muller disclose the method of claim 1, wherein the implant further comprises a head first axis, a head second axis, a head third axis, and an implant axis (see Figs. 3B and 3C of Lamm showing a head first axis 111, a head second axis 107, a head third axis 109, and an implant axis 105), wherein a first angle between the head first axis and the implant axis (as shown by the perspective of Figs. 3B and 3C of Lamm, first angle between head first axis 111 and implant axis 105 is 90 degrees), a second angle between the head second axis and the implant axis (as shown in Fig. 3C of Lamm, second angle between head second axis 107 and implant axis 105, i.e. angle alpha, is 15 degrees, as stated in para. 0050), and a third angle between the head third axis and the implant axis are different (as shown in Fig. 3C of Lamm, third angle between head third axis 109 and implant axis 105, each of the first, second and third angles being different as claimed),
Regarding claim 20, the combined teachings of Lamm and Muller disclose the method of claim 19, wherein the first angle is 90° (as shown by the perspective of Figs. 3B and 3C of Lamm, first angle between head first axis 111 and implant axis 105 is 90 degrees).
Neither Lamm nor Muller explicitly teach wherein the second angle is between 30° and 60°, and the third angle is less than 45°.
Lamm does disclose wherein the second angle between the head second axis and the implant axis may be 15 degrees or, in other embodiments, may be between 0 and 25 degrees (see para. 0050).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have slightly modified the orientation of Lamm’s neck and anchor portions 122/124 relative to the head portion 120 so that the second and third angles are within the claimed ranges, since where Lamm’s implant is generally configured to have first, second and third angles near the claimed ranges, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 21, the combined teachings of Lamm and Muller disclose the method of claim 1, wherein the second aperture comprises threads for engagement with the second fastener, and wherein the second fastener comprises a locking fastener (where Lamm’s head has been modified to include the a second aperture as shown in the head structure of Muller shown in Figs. 17-19, including first and second apertures 1434a/b, it is understood that the second aperture in Lamm’s modified device takes the form of the first aperture 130 shown in Figs. 3A-3B, so that the second aperture includes Lamm’s threads 132 for engagement with threads of a fastener 104, e.g. a locking fastener; see para. 0051 of Lamm).
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 ANNA VICTORIA LITTLE whose telephone number is (571)272-6630. The examiner can normally be reached M-F 9a-6p EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571)272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNA V. LITTLE/Examiner, Art Unit 3773
/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773
