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 § 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 14-15 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 14 at line 2 the limitation recites “chevron-shaped cutting slot is substantially superimposed over a first metatarsal”.
In claim 14 at line 4-5 the limitation recites “at least one curvilinear edge extends vertically along a first metatarsal”.
These limitations cannot be satisfied without the inclusion of the human organism, or the metatarsal, 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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 12-16, 18, 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Budoff (US Patent Pub. 20120130383A1).
Budoff recites a cutting guide system for creating an osteotomy. Specifically in regards to claim 12, Budoff recites a main body shaped to conform to an outside surface of a foot of a patient (Budoff recites that the mounting surface 28 is also nominally matched to the opposite ulnar surface 32. As for the recitation of the guide being used on the foot of a patient it is being interpreted as intended use recitation. 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.) (Fig. 2-4; Para. [0055]). The main body having: a first side end, a second side end, a length extending from the first to the second end; an axis (axis through center of 78/22/18) extending along the length (Fig. 6); a cutting slot (slot of 78) extending through the axis (Fig. 6); an alignment slot ( u-shaped slot for knob 60 in 22, Fig. 5-6) extending along the axis; and at least one adjustment hole (hole in 18 for 60 and opening 34, Fig. 2, 5-6); an insert (82) situated about the cutting slot (slot of 78); and at least one guide wire (36) insertable into the at least one adjustment hole (34) (Fig. 2-12; and Para. [0055]-[0058],[0060],[0066]-[0084]).
In regards to claim 13, Budoff recites wherein the cutting slot (slot of 78) is a chevron-shaped cutting slot (Fig. 6); wherein the main body is rotatable about the at least one guide wire (36) between a first position wherein the axis is substantially horizontal; and a second position where the axis is substantially vertical (The guide shown in Fig. 6, with only a guide wire 36 located adjacent the most distal edge is fully capable of being rotated so that the axis that bisects the guide is either horizontal or vertical.) (Fig. 6).
In regards to claim 14, Budoff recites wherein in the first position the chevron shaped cutting slot (slot of 78) is substantially superimposed over a first metatarsal (As for the recitation of the guide being used on the metatarsal in the first position it is being interpreted as intended use recitation. 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.) (Fig. 6).
In regards to claim 15, Budoff recites wherein the main body further comprises at least one curvilinear edge (edge along bottom surface 28 close to openings 34, Fig. 2) extending along a bottom perimeter of the main body; and wherein the at least one curvilinear edge extends vertically along a first metatarsal in the second position (Budoff recites that the mounting surface 28 is also nominally matched to the opposite ulnar surface 32 therefore, the edge of the lower surface would be curvilinear to match the bone. As for the recitation of the guide being used on the metatarsal in the second position it is being interpreted as intended use recitation. 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.) (Fig. 2, Para. [0055]).
In regards to claim 16, Budoff recites a targeting guide (191) comprising: a body; a targeting guide cannula (openings in 191) extending through the body (body of 191); and a pointer extending from the body (190) (Fig. 14-15; and Para. 0088]).
In regards to claim 18, Budoff recites a cutting guide system for an osteotomy medical procedure. Specifically, Budoff recites a cutting guide (22/78/18) comprising: a main body shaped to conform to an outside surface of a foot (Budoff recites that the mounting surface 28 is also nominally matched to the opposite ulnar surface 32. As for the recitation of the guide being used on the foot of a patient it is being interpreted as intended use recitation. 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.) (Fig. 2-4; Para. [0055]). The main body having: a first side end, a second side end, at least one alignment notch or slot (u-shaped slot for knob 60 in 22, Fig. 5-6) (Fig. 5-6); a plurality of openings (34/46, Fig. 2 and opening for knob in 18, Fig. 2) formed in the main body; and a cutting guide (slot of 78) formed in the main body (Fig. 6); at least one alignment screw (60) rotatably connected to the main body about at least one of the plurality of openings (opening for knob in 18, Fig. 2); at least one guide wire (36, Fig. 6); and an implant (172, Fig. 12) configured to secure two pieces of bone (130/132) together (Fig. 12) (Budoff recites that the fastener 60 and posts 38 create a three-point connection arrangement that positively maintains the desired orientation between the joined positioning guide 22 and base assembly 18.) (Fig. 2-12; and Para. [0055]-[0058],[0060],[0066]-[0089]).
In regards to claim 21, Budoff recites wherein the cutting slot (slot of 78) is a chevron-shaped cutting slot (Fig. 6).
Claim Rejections - 35 USC § 103
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 and 10-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Budoff (US Patent Pub. 20120130383A1) in view of O’Brien (US Patent Pub. 20080294170A1).
Budoff recites method of performing a medical procedure using a cutting guide system. Specifically in regards to claim 1 and 10, Budoff recites the steps of: making an incision in the patient and inserting a guide wire (36) into a bone (Fig. 5); aligning a cutting guide (18/22/78, Fig. 2 and 6) relative to a bone of a patient about the guide wire (36), the cutting guide (18/22/78) comprising: a main body having a first side end, a second side end, and an axis (axis through center of 78/22/18) extending from the first side end to the second side end (Fig. 6); a plurality of openings (46/34) formed therein (Fig. 2); and at least one edge (curved edge of 22/78); cutting a portion of a bone (124) through the cutting guide (78/18/22, Fig. 6) into a first bone piece (130) and a second bone piece (132) (Fig. 6); adjusting the location of one of the bone piece relative to the other bone piece (Fig. 10-11); and securing the first bone piece to the second bone piece (The pieces are secured by means of 172 as shown in Fig. 12) (Fig. 1-12; and Para. [0055]-[0058],[0060],[0066]-[0084]). However, the reference is silent as to the guide system being used on the foot of a patient.
O’Brien recites method of performing a medical procedure using a cutting guide system. Specifically in regards to claim 1 and 10, O’Brien recites a cutting guide (100) used on the foot of a patient specifically a metatarsal (10), and inserting a retractor into the incision (The O’Brien reference recites wherein Having a single device provide the osteotomy guide as well as retraction capabilities reduces the number of independent retractors needed for the procedure and allows bunionectomies to be performed without assistance. This thereby allows a person of skill to infer that while the tool retracts independent retractors can still be used.) (Fig. 4; and Para. [0015], [0026], [0036]-[0040]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the system and method of Budoff by using the tool on a foot with a retractor as taught in O’Brien in order to allow the device on various bones and to allow for the movement of tendons out of the way of blades.
In regards to claim 2, Budoff recites the steps of aligning a chevron-shaped cutting slot (82) of the cutting guide with a portion of a first metatarsal; and cutting the first metatarsal through the chevron-shaped cutting slot (82) (Fig. 7-9).
In regards to claim 3, Budoff recites the steps of temporarily securing a targeting guide (191) to the main body (Fig. 14-15); and inserting at least one guide wire (wire shown in Fig. 16) through the targeting guide (191) and into a first bone (Fig. 14-16; and Para. 0088]).
In regards to claim 11, Budoff recites the step of tightening at least one adjustment screw (60) rotatably attached to the main body to secure the main body to the foot (Fig. 2-6; Para. [0060],[0064]).
Allowable Subject Matter
Claims 4-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 12-19 and 21 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 9-16of U.S. Patent No. 12295589B2, referred herein as Pat. ‘589. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 12-15 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 12295589B2. Pat. ‘589 recites a main body shaped to conform to an outside surface of a foot of a patient [claim 1 Col. 14 lines 42-45], the main body having: a first end; a second end; a length extending from the first end to the second end; an axis extending along the length [claim 1 Col. 14 lines 46-53]; a cutting slot extending through the axis [claim 1 Col. 14 lines 54-55]; an alignment slot extending along the axis [claim 3]; and at least one adjustment hole [claim 1 Col. 14 lines 53]; an insert situated about the cutting slot axis [claim 1 Col. 14 lines 54-55]; and at least one guide wire insertable into the at least one adjustment hole axis [claim 1 Col. 14 lines 56-57]; wherein the main body is rotatable about the at least one guide wire between: a first position where the axis is substantially horizontal; and a second position where the axis is substantially vertical [claim 1 Col. 14 lines 58-67]; wherein in the first position the chevron-shaped cutting slot is substantially superimposed over a first metatarsal axis [claim 1 Col. 14 lines 64-67]; and wherein the main body further comprises at least one curvilinear edge extending along a bottom perimeter of the main body axis [claim 1 Col. 14 lines 51-52]; and wherein the at least one curvilinear edge extends vertically along a first metatarsal in the second position axis [claim 1 Col. 14 lines 61-63].
Claims 16-17 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-10 and 12 of Pat. ‘589 for reciting substantially similar limitations.
Claims 18 and 21 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 13-14 of U.S. Patent No. 12295589B2. Pat. ‘589 recites cutting guide system for osteotomy medical procedure comprising: a cutting guide [Claim 1 Col. 14 lines 42-43] comprising: a main body shaped to conform to an outside surface of a foot [Claim 1 Col. 14 lines 44-45]; a first end, a second end [Claim 1 Col. 14 lines 46-47]; at least one alignment notch or slot [Claim 3]; a plurality of openings formed in the main body [Claim 1 Col. 14 lines 53]; and a cutting guide formed in the main body chevron shaped insert [Claim 1 Col. 14 lines 54-55]; at least one alignment screw rotatably connected to the main body about at least one of the plurality of openings; at least one guide wire [Claim 1 Col. 14 lines 56-57]; and an implant configured to secure two pieces of bone together [Claim 13-14].
Claims 19 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-16 of Pat. ‘589 for reciting substantially similar limitations.
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 . SHIRSAT
Primary Examiner
Art Unit 3775
Prosecution Insights