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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/10/26 has been entered.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1 and 14 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
In claim 1 at lines 7-8 the limitation recites “the buttress includes a channel that can be used to provisionally position the bone fusion plate prior to attaching the buttress to the 1st metatarsal bone”.
In claim 14 at lines 6-7 the limitation recites “the buttress includes a channel that can be used to provisionally position the bone fusion plate prior to attaching the buttress to the 1st metatarsal bone”.
These limitations cannot be satisfied without the inclusion of the human organism, or the 1st metatarsal bone, therefore, applicant is claiming the metatarsal as part of the invention. Instead, applicant should use “adapted to” or “configured to” language to overcome the 101 rejection.
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) 1-2, 4-5, 7-11, 13-15, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCormick (US Patent Pub. 20140066995A1) in view of Schafer et al (US Patent Pub. 20220273348A1) and Coyne et al (US Patent Pub. 20210244443A1).
McCormick recites a bone fusion plate capable of treating hallux valgus/a lateral shift osteotomy buttress plate. Specifically in regards to claim 1 and 14, McCormick recites a plate portion (portion of 100 having 112/114) comprising a lower, distal surface; the plate portion (portion of 100 having 112/114) having a planar member having a lower, distal surface that is adapted to be attached to the surface of a metatarsal head; and a buttress (portion of 100 having 126) comprising a proximal surface wherein the buttress (portion of 100 having 126) is a thicker portion of the bone fusion plate (100) and includes a proximal surface configured to be attached to the proximal bone surface of a first metatarsal bone; and wherein the distal and proximal surfaces share an intervening buttress angle (theta) configured to fixate the first metatarsal bone and the metatarsal head (The recitation of the plate being affixed to a metatarsal bone is considered 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. In the current case the bone plate 100 is fully capable of buttressing against the metatarsal bone.) (Fig. 1-3; and Para. [0039]-[0045]). The proximal surface comprises a cut guide configured to guide cutting the first metatarsal bone (Applicant demonstrates the cutting guide as being merely the proximal surface as shown in Fig. 9a of the specification as originally filed. In the instant case the proximal surface of the buttress of the plate of McCormick can also serve as a cutting guide in a similar manner as applicant’s invention.) (Fig. 1-3). However, the reference is silent as to a buttress angle in the range of 70-110 degrees or wherein the proximal openings having a threaded countersink, or wherein the buttress includes a channel that can be used to provisionally position the bone fusion plate prior to attaching.
Schafer recites a bone fusion plate for treating hallux valgus/a lateral shift osteotomy plate. Specifically, Schafer in regards to claim 1 and 14, recites a bone fusion plate having distal and proximal surfaces which share an intervening buttress angle for fixating the 1st metatarsal bone (120) and the metatarsal head (116) (Fig. 3-4, and Para. [0006], [0023],[0025],[0028]-[0029]). Schafer regards to claims 4 and 19, recites wherein any one or more of the one or more proximal screw holes (110) includes a threaded countersink for threadably engaging a head portion of a proximal bone screw (114) (As shown in Fig. 1-2, the apertures 110 are countersunk.) (Fig. 1-6; and Para. [0033]-[0034]). In regards to claim 13 and 17, Schafer recites wherein the buttress angle ranges between about 70 degrees and about 110 degrees (Fig. 1-6; and Para. [0006],[0025]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the plate and proximal openings of McCormick to have a buttress angle in the range of 70-110 degrees and threaded countersink openings as taught in Schafer in order to allow for rotational control and easier correction and adjustment; and, the plate and its extensions provide for control and placement of the metatarsal head in the corrected construct after performance of an osteotomy (Para. [0006]). However, the references are silent as to the buttress including a channel that can be used to provisionally position the bone fusion plate prior to attaching.
Coyne recites a bone fusion plate for treating hallux valgus/a lateral shift osteotomy plate. Specifically, Schafer in regards to claim 1 and 14, recites a bone fusion plate (300, Fig. 25) having a lower, distal surface (311) that is adapted to be attached to the surface of a metatarsal head; and a buttress (313) comprising a proximal surface configured to be attached to the proximal bone surface of a first metatarsal bone, and the buttress (310/313) includes a channel (307) that can be used to provisionally position the bone fusion plate (300) prior to attaching the buttress to the 1st metatarsal bone (Fig. 5 and 25; and Para. [0052]-[0055], [0090]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the buttress of the plate of McCormick to have a channel for a guide pin in the buttress as taught in Coyne in order to allow for the implant to simultaneously be provisionally attached to an installer and surgical site for proper placement (Para. [0053]).
In regards to claims 2 and 18, McCormick recites wherein the buttress (portion of 100 having 126) includes one or more proximal screw holes (126) configured to receive bone screws (127) for attaching the buttress (portion of 100 having 126) to a proximal bone surface of a metatarsal bone (Fig. 1-2; and Para. [0040]).
In regards to claim 5, McCormick recites wherein the one or more proximal screw holes (126) are disposed in the buttress (portion of 100 having 126) at a proximal screw angle with respect to the plate portion (portion of 100 having 112/114) (Fig. 1 and 3).
In regards to claim 7, McCormick recites wherein the plate portion (portion of plate having 112/114) includes one or more distal screw holes (112/114) configured to receive bone screws (115) for attaching the plate portion to a metatarsal head (Fig. 1-3).
In regards to claim 8, McCormick recites wherein the one or more distal screw holes (112/114) are positioned at different distances from the buttress (portion with 126) (Fig. 1-3).
In regards to claim 9, McCormick recites wherein any one or more of the one or more distal screw holes (112) includes a threaded countersink (112) for threadably engaging a head portion of a distal bone screw (115) (As shown in Fig. 1-3 the non-locking screw hole 126 is oriented at an angle .theta. of about 45 degrees from the locking screw hole 112.) (Fig. 1-3; and Para. [0040]).
In regards to claim 10, McCormick recites wherein the proximal surface is configured to be attached to a proximal bone surface formed by cutting a metatarsal bone and laterally shifting the metatarsal head (The recitation of the plate being affixed to a metatarsal bone is considered 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. In the current case the bone plate 100 is fully capable of buttressing against the metatarsal bone.) (Fig. 1-3; and Para. [0039]-[0045]).
In regards to claim 11 and 15, McCormick recites wherein the proximal and distal surfaces share an intervening buttress angle suitable for fixating the metatarsal bone and the metatarsal head (Fig. 3; and Para. [0040]).
Claim(s) 3, 6, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCormick in view of Schafer and Coyne as applied to claims 2 and 18 above, and further in view of DaCosta et al (US Patent Pub. 20170325859A1).
McCormick in view of Schafer and Coyne discloses a buttress plate having a plate portion with a distal surface and distal openings and a buttress portion with a proximal surface and proximal openings. However, the reference is silent as to the proximal openings having a variable angle.
DaCosta recites a bone fusion plate for treating hallux valgus/a lateral shift osteotomy plate. Specifically, DaCosta recites a plate (400) having a proximal openings (432) and a plate portion (410/420) having distal openings (412/422) (Fig. 30-40; and Para. [0089]-[0093]). In regards to claims 3, 6, and 20, DaCosta recites wherein any one or more of the one or more proximal screw holes (432) includes a conical relief adapted to allow for variable screw angulation for a range of osteotomy shifts (Fig. 39-40; and Para. [0047], [0098]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the opening (126) of McCormick to be a variable angle opening as taught in DaCosta in order to allow for the fastener to be inserted in an off-axis position (Para. [0068]).
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the arguments do not apply to the new combination of references being used in the current rejection.
Conclusion
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
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