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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 20, 2026, has been entered.
Response to Amendment
According to the amendment filed March 20, 2026, claims 1 and 17 have been amended, claim 18 has been canceled, and new claims 19 and 20 have been added.
Election/Restrictions
Claim 17 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species C, as currently amended, there being no allowable generic or linking claim. Election was made without traverse in a telephone conversation with Adam Forman on May 5, 2025, and confirmed in the reply filed on August 18, 2025.
Response to Arguments
Applicant's arguments filed March 20, 2026, have been fully considered but they are not persuasive.
On page 8 of Remarks, regarding the rejection of claims 1-10 and 17 under 35 U.S.C. 103 as unpatentable over Lamm (US 2020/0015865 A1) in view of Muller (US 2019/0125418 A1) and Zakhary (US 2020/0170655 A1), Applicant asserts that the Office’s “reliance on Zakhary is misplaced” and asserts the following:
First, “a person of ordinary skill in the art would not understand Zakhary’s compression portion 20 to be a part of the head as described in the Office’s first interpretation, even under the broadest reasonable interpretation approach” – where Zakhary describes the implant including three portions: insertion portion 18, compression portion 20 and fixation portion 22, such that one would only reasonably modify the central portion (neck 124) of Lamm to include an aperture for the second fastener (page 8)
Second, because the Office’s second interpretation of Zakhary acknowledges that the second aperture 30 is not located on the head of the implant (and instead on a neck portion of the implant), Applicant concludes that the first interpretation in which the Office defined the head portion of Zakhary’s implant differently so as to include the second aperture) is incorrect.
Examiner respectfully disagrees. It is noted that the term “head” is understood, in the context of an object, as a portion of the object or device that performs or corresponds to the primary function(s) thereof, typically associated with an enlarged part of the object. Other definitions of the term taken from Merriam-Webster (https://www.merriam-webster.com/dictionary/head) include: “the uppermost extremity or projecting part of an object” (defn. 9a) and “the part of an apparatus that performs the chief function or a particular function” (defn. 18a).
Firstly, the Office’s reliance on one interpretation of Zakhary defining the second aperture in a “neck” of the implant” (i.e., the second interpretation applied in the rejection of claims 1 and 18) does not preclude or invalidate the alternate interpretation of the second aperture being located in the head of the implant (i.e., first interpretation applied in the rejection of claims 1-10 and 17) (as applied in the rejection of claims. In view of the definitions of the term “head” noted above, one of ordinary skill in the art would reasonably consider that Zakhary’s implant (depicted in Fig. 1A, copied below for reference) may be understood as having a head portion defined solely by portion 22 (between end 16 and midpoint 24b, where such a head portion is an enlarged part and performs a primary function of the device by receiving fasteners in corresponding apertures) or, alternatively, a head portion defined collectively by portion 22 and at least a portion of compression section 20 that includes the second aperture 30 (where such a head portion includes an enlarged part of the device and still performs a primary function of the device, receiving the above-mentioned fasteners in portion 22 and a compression fastener in second aperture 30).
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Fig. 1A of Zakhary
Secondly, Zakhary is applied as a teaching reference to modify the implant of Lamm to include a second aperture for effecting compression between proximal and distal metatarsal portions. Lamm’s implant is depicted below for reference, shown having the head portion 120, a neck portion 124 and an anchor portion 122. In response to Applicant’s argument that one of ordinary skill in the art would only reasonably modify Lamm’s implant to comprise Zakhary’s second aperture in the neck portion 124, Examiner notes that Lamm recites, in paragraph [0052], that the “length of the nail between the first and second ends 106, 108 can vary, as can the relative lengths of the head, neck and/or anchor portions” and that the “width of the neck 124 between the superior 114 and inferior 116 sides may also vary”.
Thus, one of ordinary skill in the art would reasonably extend/elongate the length of Lamm’s head portion, or widen a portion of the neck near the head portion, so as to accommodate Zakhary’s second aperture, wherein the modified portion comprising Lamm’s first aperture and Zakhary’s second aperture defines the “head” of the implant (i.e., having an enlarged part and apertures providing for a primary function of the implant), because Zakhary recognizes that providing first and second apertures and fasteners in the head portion of an implant aids in attaching the implant and effecting compression between the resected first and second metatarsal bone portions (see Zakhary, Figs. 7-8I and para. 0085-0086). Further, it is noted that while Lamm’s figures depict an implant where the neck and anchor are free from openings, Lamm contemplates the inclusion of other openings, stating in paragraph [0052] that “other embodiments could include openings for supplementary fixation”.
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Fig. 3A of Lamm
For at least these reasons, Applicant’s arguments regarding the rejection of claim 1 are unpersuasive, and the rejection of claim 1 under 35 U.S.C. 103 as being unpatentable over Lamm, Muller and Zakhary has been maintained below.
Claim Objections
Claim 2 is objected to because of the following informalities:
In line 2 of claim 2, “sliding cannulated screw” should read ---sliding the cannulated screw---.
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 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lamm (US 2020/0015865 A1) in view of Muller (US 2019/0125418) and Zakhary (US 2020/0170655 A1).
Regarding claim 1 (Currently Amended), 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 (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 a 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.
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, Zakhary, in analogous art, is directed towards an implant for correcting a bunion (see implant 2 in Figs. 1A-C, for correcting a bunion deformity as shown in Figs. 7 and 8A-8I; para. 0043-0045, 0077-0086), the implant (2; Figs. 1A-1C) comprising a monolithic body (as shown; Figs. 1A-1C) having a head (defined by fixation portion 22 and at least a portion of compression portion 20 having aperture 30; Fig. 1A; para. 0045) and an anchor (defined by insertion portion 18; Fig. 1A; para. 0045).
Zakhary discloses wherein the head (22, 20; Fig. 1A) comprises a first aperture (40a; Fig. 1A) and a second aperture (30; Fig. 1A), and the method for correcting a bunion includes:
inserting a first fastener (722a; Fig. 8E) through the first aperture of the head of the implant and into the distal metatarsal portion (at step 614 in Fig. 7, illustrated in Fig. 8E, a first screw 722a is inserted through first aperture 40a in portion 22 of the head of implant 2 and into first metatarsal portion 702a; para. 0082; also see Figs. 1A-C); and
inserting a second fastener (724; Fig. 8I) through the second aperture of the implant and into the proximal metatarsal portion that underlies the second aperture (at step 624 in Fig. 7, illustrated in Fig. 8I, a second screw 724 is inserted through second aperture 30 in portion 20 of the head of implant 2 and into the second metatarsal portion 702b; para. 0086; also see Figs. 1A-C);
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 comprise a section with a second aperture for receiving a second fastener, so that the method includes inserting a second fastener/screw through the second aperture and into the proximal metatarsal portion, as taught by Zakhary (i.e., where the second aperture is angled so that a screw inserted therethrough engages the first metatarsal portion for further attaching the implant head to the metatarsal portions with the first fastener coupling the head to the distal metatarsal portion), because Zachary teaches that providing first and second apertures and fasteners in the claimed configuration aids in attaching the implant and effecting compression between the resected first and second metatarsal bone portions (see Zakhary, Figs. 7-8I and para. 0085-0086).
Regarding claim 2, the combined teachings of Lamm, Muller and Zakhary 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, Muller and Zakhary 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, Muller and Zakhary 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, Muller and Zakhary 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 Zakhary’s second aperture 30 and second fastener 724 in the form of a screw, see Figs. 1A, 8I and para. 0086 of Zakhary, the second aperture being angled so that the second fastener/screw attaches Lamm’s modified implant head to the proximal metatarsal portion).
Regarding claim 6, the combined teachings of Lamm, Muller and Zakhary 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, Muller and Zakhary 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, Muller and Zakhary 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, Muller and Zakhary 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, Muller and Zakhary 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 (New), the combined teachings of Lamm, Muller and Zakhary 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 (New), the combined teachings of Lamm, Muller and Zakhary 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 or Zakhary, 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Other relevant references can be found in the attached PTO-892, including Muller (US 2021/003045 A1) which teaches an implant having first and second apertures formed in a head portion of the implant, the apertures being aligned along a proximal-distal direction of the implant.
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 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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