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 Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites two images. For reasons of clarity and to prevent confusion they should be labeled as separate images. For example, “receive a first image” and “receive a second image” or the like. Appropriate correction is required.
Response to Arguments
Applicant's arguments filed 09/10/2025 and 10/16/2025 have been fully considered but they are not persuasive. Applicant does not specifically point out why the prior art, specifically Nikonovas (US 2011/0313418 A1), does not teach the claimed subject matter. Therefore, the rejection is maintained.
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) 1 – 13 and 15 - 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nikonovas (US 2011/0313418 A1).
Regarding claim 1, Nikonovas discloses a system (Abstract) fully capable for correcting a foot of a patient in need thereof, comprising:
a bone fixation device (Fig. 1) comprising a first ring (ref. 106) and a second ring (ref. 108) connected by at least two interposed struts (Fig. 1, ref. 116), each strut having a respective adjustable length (paragraph [0015]);
a display (paragraph [0024] discloses displaying captured images); and
a processor (paragraph [0005] discloses a processor) configured to:
receive an indication of an orientation of at least one of the first and second rings with respect to a transverse plane of the patient's foot (the processor is fully capable of receiving an indication of an orientation as shown in Fig. 2, paragraph [0026]);
receive an indication of which of the first ring or the second ring is a reference ring (the hardware required to receive an orientation would also be capable of indicating a reference ring);
receive initial lengths of each strut (paragraph [0026]);
receive an image (ref. 126, Fig. 2) of the patient's foot in a first axis (ref. 304) with a pair of spaced apart fiducials affixed to a surface of the foot (paragraph [0049] discloses marker elements implanted on the patient and are fully capable of being planted on a surface of the foot);
receive an image of the patient's foot in a second axis (ref. 128, Fig. 2) with the pair of fiducials affixed to the surface of the foot, wherein both images are in the same view and the fiducials are not the same distance apart in the first axis image and the second axis image (because the processor is configured to receive multiple images, it is therefore fully capable of receiving two different images in the same view but along different axes);
receive an indication of an initial anatomical position of at least one bone in the patient's foot (paragraph [0022], Fig. 3, refs. 304, 06);
receive an indication of a planned anatomical position of the bone in the patient's foot (ref. 310, Fig. 3); and
generate a strut adjustment plan relative to the reference ring for changing the length of at least one strut, thereby moving the bone toward the planned anatomical position (Fig. 3, refs. 310, 312, 314).
Regarding claim 2, Nikonovas discloses the system of claim 1, wherein the processor is further configured to store the reference ring indication and use the reference ring indication to generate subsequent additional planning screens (paragraph [0056] discloses memory, thus being fully capable of storing information).
Regarding claim 3, Nikonovas discloses the system of claim 1, wherein the processor is further configured to display cut lines to represent different osteotomy locations (the processor is fully capable of display cut lines because it configured to display image parameters).
Regarding claim 4, Nikonovas discloses the system of claim 3, wherein the processor is further configured to suggest at least one cut line or joint line location (the processor is fully capable of suggesting a location or action for the surgeon based upon image parameters gathered).
Regarding claim 5, Nikonovas discloses the system of claim 1, wherein the processor is further configured to determine a first fragment and a second fragment of the bone based on an osteotomy selection (the processor if sully capable of determining fragments based upon markers or image analysis, Fig. 3, ref. 304).
Regarding claim 6, Nikonovas discloses the system of claim 1, wherein the processor is further configured to receive an assignment of a plurality of bones of the foot to the reference ring (the processor is fully capable of receiving information pertaining to the bones and reference ring, Fig. 3, refs. 304, 306).
Regarding claim 7, Nikonovas discloses the system of claim 1, wherein the processor is further configured to overlay at least one of a label or a measurement over an image of the patient's foot and the bone fixation device (paragraphs [0048-49] discloses the use of points, lines, conics or the like in addition to marker elements used in the 3-D representation, Fig. 2).
Regarding claim 8, Nikonovas discloses the system of claim 1, wherein the processor is further configured to store at least one of a first center line and a second center line, a first reference point and a second reference point, or an indication of pronation or supination (paragraph [0048] discloses reference points and paragraph [0056] discloses memory, thus being fully capable of storing a center line or reference point or indication of pronation or supination).
Regarding claim 9, Nikonovas discloses the system of claim 1, wherein the processor is further configured to store information regarding a change in the length of the at least one strut and use the information to update the strut adjustment plan (the processor is fully capable of storing information via the memory capabilities).
Regarding claim 10, Nikonovas discloses the system of claim 1, wherein the processor is further configured to:
divide a set of movements required to achieve the planned anatomical position into incremental subsets of movements over a period of time;
compare each change in the length of at least one strut required in a subset to a predetermined value; and
if the change in the length of the at least one strut is less than or equal to the predetermined value, store the strut adjustment plan (the processor is fully capable of performing these functions because it is configured to perform image analysis, mathematical computations and generate a treatment plan, see Fig. 3).
Regarding claim 11, Nikonovas discloses the system of claim 1, wherein the processor is further configured to:
compare the images to determine a three-dimensional (3D) model of the initial anatomical position (Fig. 2, ref. 129);
determine a rotation to move from the initial anatomical position to the planned anatomical position (the processor is fully capable of determining a rotation, see ref. 310, 312); and
determine changes in the struts' lengths to produce the correction (ref. 310, 312).
Regarding claim 12, Nikonovas discloses the system of claim 1, wherein the processor is further configured to:
receive input comprising a tracing of the bone in the second axis image; and extrapolate a position of the bone in the first axis image from the tracing (the processor is fully capable of performing these steps because it is configured to receive input, ref. 306, and extrapolate or calculate a position of the bone or component of the device ref, 312).
Regarding claim 13, Nikonovas discloses the system of claim 1, wherein the processor is further configured to:
receive an image of the patient's foot in a third axis with the pair of fiducials affixed to the surface of the foot, wherein all three images are in the same view (the processor is fully capable of receiving a variety of images, paragraph [0022] discloses a plurality of images which may be taken in the same view but at different angles).
Regarding claim 15, Nikonovas discloses the system of claim 1, wherein respective positions of the fiducials are used to determine a center of rotation or a translation for the planned anatomical position and/or to create a three-dimensional (3D) bone model (paragraphs [0048, 50] discloses the use of the fiducials refs. 134, 136 to help generate the 3D bone model).
Regarding claim 16, Nikonovas discloses the system of claim 1, wherein the bone fixation device comprises a third ring (paragraph [0012]) and a total of twelve struts, wherein six struts are interposed between the first and second rings, and wherein six struts are interposed between the second and third rings (Fig. 2 shows 6 struts between two adjacent rings, thus a total of 12 struts when the third ring is used).
Regarding claim 17, Nikonovas discloses a system (Abstract) fully capable of being for correcting a foot of a patient, comprising:
a bone fixation device comprising a first ring (ref. 106) and a second ring (ref. 108) connected by at least two interposed struts (ref. 116, Fig. 1), each strut having a respective adjustable length (paragraph [0015]);
a display (paragraph [0024] discloses displaying captured images); and
a processor (paragraph [0005] discloses a processor) configured to:
receive an indication of which of the first ring or the second ring is a reference ring (the hardware required to receive an orientation would also be capable of indicating a reference ring);
receive an image (ref. 126, Fig. 2) of the patient's foot in a first axis (ref. 304) with a pair of spaced apart fiducials affixed to a surface of the foot (paragraph [0049] discloses marker elements implanted on the patient and are fully capable of being planted on a surface of the foot);
receive an image of the patient's foot in a second axis (ref. 128, Fig. 2) with the pair of fiducials affixed to the surface of the foot, wherein both images are in the same view and the fiducials are not the same distance apart in the first axis image and the second axis image (because the processor is configured to receive multiple images, it is therefore fully capable of receiving two different images in the same view but along different axes);
display a representation of the patient's foot in a first view (Fig. 2. Ref. 127);
display a representation of the patient's foot in a second view (Fig. 2, ref. 129);
receive an indication of a three-dimension planar cut of at least one bone in the patient's foot to afford a first fragment and a second fragment (the processor is fully capable of receiving an indication of a 3D cut since the processor is configured to receive image data and display a 3D representation); and
generate a strut adjustment plan relative to the reference ring for changing the length of at least one strut, thereby moving at least one of the fragments from an initial anatomical position toward a planned anatomical position (Fig. 3, refs. 310, 312, 314).
Regarding claim 18, Nikonovas discloses the system of claim 17, wherein the processor is further configured to:
display cut lines to represent different osteotomy locations; or suggest at least one cut line or joint line location (the processor is fully capable of displaying cut lines or suggesting a cut line location since the processor is configured to display image scene parameters ref. 306).
Regarding claim 19, Nikonovas discloses the system of claim 17, wherein the processor is further configured to receive an assignment of a plurality of bones of the foot to the reference ring (Fig. 3, refs. 304, 306, 308), wherein at least one of the bones of the plurality of bones is not directly mechanically fixed to the reference ring but will move based on its attachment to other bones of the plurality of bone (this is considered an intended use limitation because the bones are not part of the claimed system but part of the intended use of the system, therefore the system and processor are fully capable of functioning in such a way since they are disclosed as being configured to receive an assignment of bones to be identified).
Regarding claim 20, Nikonovas discloses the system of claim 17, wherein the processor is further configured to:
determine a rotation to move from the initial anatomical position to the planned anatomical position; and
determine changes in the struts' lengths to produce the correction (the processor is fully capable of determining a rotation and changes to length through calculations and analysis of the image parameters, Fig. 3, ref. 314).
Regarding claim 21, Nikonovas discloses the system of claim 17, wherein the processor is further configured to store an indication of pronation or supination (paragraph [0056] discloses different types of memory, thus being fully capable of storing information, such as an indication of pronation or supination).
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 TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
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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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/TESSA M MATTHEWS/Examiner, Art Unit 3773