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 .
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.
Claim 6 is 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.
Claim 6 is rejected as indefinite for the recitation of “a coupling bump” in line 1. It is unclear if the coupling bump recited in claim 6 is meant to be the same as recite in claim 1 lines 5-7 or a new coupling bump. In the interest in compact prosecution the limitation will be interpreted as a further recitation of the bump recited in claim 1.
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.
Claim(s) 1, 5-6, 7-9, 11, 13-14, 16-17, 21, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luttrell et al (US Patent Pub. 20200046374A1).
Luttrell recites a surgical guide. Specifically in regards to claim 1 and 6, Luttrell recites a body (901) having a first portion (first half of 901 made up of 910/911) with a first and second ridges (ridges creating 913), and a second portion (second half of 901 made up of 910/911) with a first and second ridges (ridges creating 913); an insert (920) disposed between the first and second ridges of the first and second portions (Fig. 23), wherein the insert (920) is configured to rotate relative to the body (901); the insert (920) and body (901) defining a recess (913) and coupling bumps (921,922) and a guide aperture (aperture shown in fig. 23) disposed within the insert (920) that is sized to receive a surgical instrument (Fig. 19-23; and Para. [0073]-[0080]). However, this embodiment of Luttrell is silent as to a series of coupling bumps circumferentially arranged to retain the insert within the body.
Luttrell in a separate embodiment shown in Fig. 2a-2b, demonstrates a body (102d) and an insert (110/120) wherein one or more recess are sized and circumferentially arranged to receive corresponding coupling bumps (116a-h) to hold the insert (110/120) and body (102d) together (It would have been obvious to move the detents from the insert to be on the body and place the recess onto the insert since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art.) (Fig. 2b; and Para. [0034]). In regards to claim 6, Luttrell recites a coupling bump (116) is located within one of the circumferentially arranged recesses defined by the body (102d) so as to releasably fix the insert (120/110) relative to the body (Fig. 2b). It would have been obvious to one having ordinary skill in the art at the time the invention was file to modify the bumps (921/922) and recess (913) of the embodiment of Luttrell shown in Fig. 19-23 to be a series of bumps and recess as taught in the embodiment in Fig. 2b since it allows for a more precision rotational positioning of the insert within the body by the surgeon.
In regards to claim 5, Luttrell recites wherein the insert (920) further comprises one or more holes disposed through the insert configured to allow one or more fixation elements to pass through the insert and into a bone (The aperture in 920 is fully capable of allowing the passage of a fixation element.) (Fig. 23).
In regards to claim 7-8, Luttrell recites a plurality of indicia configured to indicate a change in orientation of the guide aperture as the insert is rotated, and wherein the insert (920) further comprises an indicator disposed on the insert (920) configured to point to one of the plurality of the indicia (Para. [0080]).
In regards to claim 9, Luttrell recites wherein the insert (920) is rotatable in 360 degrees with respect to the body (901) (Fig. 20-23; and Para. [0079]).
In regards to claim 11, Luttrell recites wherein the guide aperture is an opening configured to receive the surgical instrument (The opening shown in Fig. 23, is fully capable of accepting a surgical instrument.) (Fig. 23).
In regards to claim 13, Luttrell recites wherein the guide aperture (aperture Fig. 23) is a radiolucent material (claim 23).
In regards to claim 14, Luttrell recites wherein the insert (920) further comprises a plurality of radiopaque markers disposed within the insert (920) (Para. [0077]).
In regards to claim 16-17, Luttrell recites wherein the body (901) is generally circular, and wherein the insert (921) is generally circular (Fig. 19-23).
In regards to claim 21, Luttrell recites a handle (910/904 sticking out from 901) configured to remove the surgical guide from a bone (Fig. 19-21).
In regards to claim 23, Luttrell recites wherein the insert (920) defines an aperture that is sized and configured to receive a sight and an alignment ring (The aperture in 920 as shown in Fig. 23 has a counterbore in the top and bottom opening which are capable of fitting a ring therein.) (Fig. 23).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luttrell in view of Taylor et al (US Patent Pub. 20120253410A1).
Luttrell recites a surgical guide comprising a body having first and second portions each having first and second ridges for accepting an insert with a guide aperture. In regards to claims 2-3, Luttrell recites wherein the body (901) includes a plurality of first and second protrusions (904m/902m) (Fig. 19). However, the reference is silent as to a plurality of protrusions with openings for k-wires.
Taylor recites a surgical guide. In regards to claims 2-3, Taylor recites wherein the body (body of 3900) includes a plurality of first and second protrusions (3905/3913) that define a plurality of channels (3907/3909/3915) configured to allow one or more fixation elements (3919/3921/3923/3925) to pass through the body into a bone, and wherein the one or more fixation elements are k-wires (Fig. 39; and Para. [0353]-[0355]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the protrusions of Luttrell to have channels for k-wires as taught in Taylor as a means to secure the guide to the bone member once the guide is in the proper position (Para. [0354]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luttrell in view of Renne et al (US Patent Pub. 20190274785A1).
Luttrell recites a surgical guide comprising a body having first and second portions each having first and second ridges for accepting an insert with a guide aperture. However, the reference is silent as to an irrigation port.
Renne recites a surgical guide. In regards to claim 4, Renne recites a guide (500) comprising an irrigation port (506) configured to provide irrigation to a surgical site (Fig. 10; and Para. [0073]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the guide (900) of Luttrell to an irrigation port as taught in Renne to allow guided cooling around the drill site to ensure application and flow of irrigation solution at the surgical site (Para. [0073]).
Claim(s) 10, 12, 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luttrell in view of Frey et al (US Patent Pub. 20180271602A1).
Luttrell recites a surgical guide comprising a body having first and second portions each having first and second ridges for accepting an insert with a guide aperture. However, the reference is silent as to the guide aperture being a slot, made of metal, and the guide is patient specific.
Frey recites a surgical guide. In regards to claim 10, Frey recites a guide (10) wherein the guide aperture (20) is a slot configured to receive the surgical instrument (Fig. 3; and Para. [0184]). In regards to claim 12, Frey recites wherein the guide aperture (20) is a metal material (The insert 24 is a metal material.) (Fig. 3; and Para. [0191]). In regards to claim 18-19, Frey recites wherein the surgical guide (10) has a patient-specific surface (14a/14b), and wherein the patient-specific surface of the surgical guide is based at least in part on pre-operative imaging of a bone (Fig. 2-3; and Para. [0182]). In regards to claim 20, Frey recites wherein the guide aperture (20) is substantially rectangular, transverse, a wedge shape, or a chevron shape (Fig. 3). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the guide aperture of the insert (920) of Luttrell to be a metallic slot and be patient specific as taught in Frey in order to withstand the high temperatures used in the sterilization process (Para. [0191]), and to ensure that the guide can sit upon the surgical site in one specific correct direction.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luttrell in view of Sikora et al (US Patent Pub. 20180193034A1).
Luttrell recites a surgical guide comprising a body having first and second portions each having first and second ridges for accepting an insert with a guide aperture. However, the reference is silent as to the first and second portions being two parts coupled by pins.
Sikora recites a surgical guide. In regards to claim 15, Sikora recites a guide (200) having first and second portions (240/244), and wherein the first and second portions (240/244) are two separate parts that are coupled together with two pins (284) (Fig. 3a-3c; and Para. [0064]-[0066]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the body (901) of Luttrell to be two separate portions connected by pins as taught in Sikora since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luttrell in view of Dacosta et al (WO2021211993A1).
Luttrell recites a surgical guide comprising a body having first and second portions each having first and second ridges for accepting an insert with a guide aperture. However, the reference is silent as to the insert having holding features.
Dacosta recites a surgical guide. In regards to claim 22, Dacosta recites wherein the insert (408) defines one or more holding features (409) configured to receive a fixation element (406) (Fig. 21; and Para. [0069]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the insert (920) of Luttrell to have a holding feature as taught in Dacosta in order to allow for the insert to pivot and couple to a base (Para. [0069]).
Response to Arguments
Applicant’s arguments regarding the 112 rejection regarding the locking device of claim 6 are moot based on the amendments filed on 9/30/25. However, a new rejection has been made.
Applicant's arguments filed 9/30/25 have been fully considered but they are not persuasive. Applicant argues that the Luttrell reference does not demonstrate the insert and body having coupling bumps that fit into recesses in any of its embodiments (Remarks pg. 5-8). However, as shown in Fig. a-2b Luttrell demonstrates a series of detents that are circumferentially arranged around the insert thus joining the two pieces together. Therefore, the continued rejection of the claims is proper.
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 MARCELA I SHIRSAT whose telephone number is (571)270-5269. The examiner can normally be reached M-F 9:00am-5:30pm MST.
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/MARCELA I. SHIRSAT/ Primary Examiner, Art Unit 3775