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 .
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.
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Claims 3-16 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,324,693 (Bertram ‘693). Although the claims at issue are not identical, they are not patentably distinct from each other because the narrower claims of the current application are anticipated by the broad claims of Betram ‘693
Regarding claim 3:
Bertram ‘693 discloses a method of projecting an incision marker emitted from a laser onto a patient using an associated medical imaging system including an x-ray detector and a gantry, the gantry comprising a base and a ring carrying the x-ray detector, wherein the x-ray detector is movable on the ring, wherein the laser and the x-ray detector are mutually attached for movement of the laser together with movement of the x-ray detector, the method comprising:
capturing, using the x-ray detector disposed at a first position on the ring of the gantry, a fluoroscopic image of at least a part of bony structure of the patient from a viewing direction onto the patient (Claim 1);
setting a virtual marker at a first position in the captured fluoroscopic image (Claim 1);
moving the laser relative to the patient by moving the x-ray detector mutually attached with the laser along the ring to a second position of the x-ray detector on the ring (Claim 1), wherein the second position of the x-ray detector on the ring is different than the first position of the x-ray detector on the ring (Claim 1); and
with the x-ray detector disposed at the second position on the ring, controlling the laser to project the incision marker onto the patient from a projection direction different than the viewing direction (Claim 1), wherein the incision marker is projected onto the patient at a first position on the patient in accordance with the virtual marker set at the first position in the fluoroscopic image (Claim 1).
Regarding claim 4:
Bertram ‘693 discloses the method of claim 3, wherein an angle between the viewing direction and the projection direction lies between 85° and 95° (claim 2).
Regarding claim 5:
Bertram ‘693 discloses the method of claim 3, further comprising:
with the x-ray detector at the first position on the ring, projecting, by the laser, an imaging marker onto the patient, wherein the imaging marker indicates a position of the fluoroscopic image on the patient when the fluoroscopic image is captured (Claim 3).
Regarding claim 6:
Bertram ‘693 discloses the method of claim 5, wherein the setting the virtual marker at the first position in the fluoroscopic image comprises:
overlaying an initial virtual marker over the fluoroscopic image of the least a part of the bony structure of the patient (Claim 7), wherein a position of the initial virtual marker overlaid in the fluoroscopic image corresponds with a position of the imaging marker projected onto the patient (Claim 7).
Regarding claim 7:
Bertram ‘693 discloses the method of claim 6, further comprising: changing the position of the initial virtual marker to obtain the virtual marker (Claim 8).
Regarding claim 8:
Bertram ‘693 discloses the method of claim 3, wherein the setting the virtual marker in the fluoroscopic image comprises setting a point in the fluoroscopic image (Claim 4)
Regarding claim 9:
Bertram ‘693 discloses the method of claim 8, further comprising projecting by the laser a point or a crosshair as the incision marker (claim 9).
Regarding claim 10:
Bertram ‘693 discloses the method of claim 3, wherein: the capturing the fluoroscopic image of the at least a part of the bony structure of the patient comprises
capturing a fluoroscopic image of at least a part of a spine of the patient (Claim 5); and
the setting the virtual marker comprises setting a virtual marker that indicates a vertical position on the spine (Claim 5).
Regarding claim 11:
Bertram ‘693 discloses the method of claim 10, wherein:
the controlling the laser to project the incision marker onto the patient in accordance with the virtual marker comprises projecting a line onto the patient (Claim 10).
Regarding claim 12:
Bertram ‘693 discloses the method of claim 3, further comprising:
setting a second virtual marker in the fluoroscopic image (Claim 6); and
controlling the laser to project a second incision marker in accordance with the second virtual marker (Claim 6).
Regarding claim 13:
Bertram ‘693 discloses A non-transitory computer readable storage medium storing a program that, when running on a computer that is connected with an associated medical imaging system including an x-ray detector, a laser, and a gantry, the gantry comprising a base and a ring carrying the x-ray detector, wherein the x-ray detector is rotatable on the ring, wherein the laser and the x-ray detector are mutually attached for movement of the laser together with the x-ray detector, causes the computer to perform steps comprising:
acquiring a fluoroscopic image of at least a part of bony structure of a patient from a viewing direction onto a patient (Claim 11), the fluoroscopic image being captured by the x-ray detector disposed at a first position on the ring of the gantry;
receiving user input representing a virtual marker set at a first position in the acquired fluoroscopic image (claim 11); and
outputting control parameters for:
moving the laser relative to the patient by moving the x-ray detector mutually attached with the laser along the ring to a second position of the x-ray detector on the ring (Claim 11), wherein the second position of the x-ray detector on the ring is different than the first position of the x-ray detector on the ring (Claim 11); and
controlling the laser with the x-ray detector disposed at the second position on the ring to project an incision marker onto the patient from a projection direction different from the viewing direction (Claim 11), wherein the incision marker is projected onto the patient at a first position on the patient in accordance with the virtual marker set at the first position in the fluoroscopic image (Claim 11).
Regarding claim 14:
Bertram ‘693 discloses the non-transitory computer readable storage medium according to claim 13, further comprising:
with the x-ray detector at the first position on the ring, controlling the laser to project an imaging marker onto the patient (claim 12) , wherein the imaging marker indicates a position of the fluoroscopic image on the patient when the fluoroscopic image is captured (Claim 12),
Regarding claim 15:
Bertram ‘693 discloses the non-transitory computer readable storage medium according to claim 14, further comprising:
overlaying an initial virtual marker over the fluoroscopic image (Claim 14), wherein a position of the initial virtual marker in the fluoroscopic image corresponds with a position of the imaging marker projected onto the patient (Claim 14).
Regarding claim 16:
Bertram ‘693 discloses the non-transitory computer readable storage medium according to claim 13, further comprising:
controlling the laser to project at least one of point, a line and/or a crosshair as the incision marker (Claim 13).
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Stoutenburgh (U.S. 2015/0208998) in view of Kotian (U.S. 2018/033208).
Regarding claim 1:
Stoutenburgh discloses a medical imaging system comprising:
a gantry (Fig. 2a, 33) comprising a base (Fig. 2a, 40) and a ring (Fig. 2a, 61);
an x-ray source (Fig. 2a, 31) operably coupled with the gantry (Fig. 2a, 33), the x-ray source being operable to emit an x-ray beam ([0038], radiation emission);
an x-ray detector (Fig. 2a, 32) movable on the ring of the gantry (Fig. 2a, 33), the x-ray detector being operable to detect the emitted x-ray beam ([0038], detector detects radiation); and
a laser ([0046], laser).
However, Stoutenburgh fails to disclose a laser mutually attached with the x-ray detector for movement of the laser together with movement of the x-ray detector on the ring of the gantry.
Kotian teaches a laser mutually attached with the x-ray detector ([0037], laser attached with the detector) for movement of the laser together with movement of the x-ray detector on the ring of the gantry ([0064], detector rotates which means the lasers rotate with the detector).
It would have been obvious to one of an ordinary skill in the art before the effective filing date to combine the system of Stoutenburgh with the laser taught by Kotian in order to improve the accuracy of the needle guidance by improving laser positioning (Kotian; [0072]). KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Stoutenburgh (U.S. 2015/0208998) in view of Kotian (U.S. 2018/033208) as applied to claim 1, and further in view of Shalayev (U.S. 2019/0076195).
Regarding claim 2:
The combination of Stoutenburgh and Kotian discloses the medical imaging system according to claim 1.
However, the combination of Stoutenburgh and Kotian fails to disclose wherein: the x-ray detector is operable to capture, being disposed at a first position on the ring of the gantry, a fluoroscopic image of at least a part of bony structure of a patient from a viewing direction onto the patient; and the laser is operable to project, with the x-ray detector being disposed at a second position on the ring of the gantry different than the first position on the ring of the gantry, an incision marker onto the patient from a projection direction different than the viewing direction.
Shalayev teaches the x-ray detector is operable to capture, being disposed at a first position on the ring of the gantry, a fluoroscopic image of at least a part of bony structure of a patient from a viewing direction onto the patient (Shayalev; [0031] and [0042], imaging of spine); and
the laser is operable to project, with the x-ray detector being disposed at a second position on the ring of the gantry different than the first position on the ring of the gantry (Shayalev; [0031] and [0042], imaging of spine), an incision marker onto the patient from a projection direction different than the viewing direction ([0041], lasers project incision path).
It would have been obvious to one of an ordinary skill in the art before the effective filing date to combine the system of Stoutenburgh with the bony imaging taught by Shayalev. One would have been motivated to make such combination in order to provide imaging of the spine for better incision trajectory around the area. Therefore, it would have been obvious to one of an ordinary skill in the art to combine the system of Stoutenburgh with the bony imaging taught by Shayalev to yield predictable results. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Allowable Subject Matter
Claims 3-16 would be allowable if rewritten or amended to overcome the double patenting rejection(s), set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior arts are Shalayev (U.S. 2019/0076195) in view of Kotian (U.S. 2018/033208), and Stoutenburgh (U.S. 2015/0208998).
Regarding claim 3:
Shalayev discloses a method of projecting an incision marker onto a patient using an associated medical imaging system comprising at least one laser that is adjustable relative to the gantry, the method comprising:
capturing a fluoroscopic image of at least a part of bony structure of the patient from a viewing direction onto the patient ([0052], fluoroscopic image captured of bones)
setting a virtual marker at a first position in the fluoroscopic image (Fig. 3b, 304);
controlling the at least one laser to project the incision marker onto the patient from a projection direction different from the viewing direction ([0041], lasers project incision path), wherein the incision marker is projected onto the patient at a first position on the patient in accordance with the virtual marker set at the first position in the fluoroscopic image ([0041], lasers project incision path).
Stoutenburgh teaches the gantry (Fig. 2a, 33) comprising a base (Fig. 2a, 40) and a ring (Fig. 2a, 61) carrying the x-ray detector (Fig. 2a, 32), wherein the x-ray detector is movable on the ring ([0019], detector rotation).
Kotian teaches wherein the laser and the x-ray detector are mutually attached for movement of the laser together with movement of the x-ray detector ([0064], detector rotates which means the lasers rotate with the detector),
moving the laser relative to the patient by moving the x-ray detector mutually attached with the laser along the ring to a second position of the x-ray detector on the ring([0064], detector rotates which means the lasers rotate with the detector), wherein the second position of the x-ray detector on the ring is different than the first position of the x-ray detector on the ring ([0064], detector rotates which means the detectors are at a different position).
However, Shalayev, Kotian, and Stoutenburg fail to teach capturing, using the x-ray detector disposed at a first position on the ring of the gantry, a fluoroscopic image; and with the x-ray detector disposed at the second position on the ring, controlling the laser to project the incision marker onto the patient from a projection direction different than the viewing direction.
Since the prior art of record fails to teach the details above, nor is there any reason to modify or combine prior art elements absent of applicant’s disclosure, the claim is deemed patentable over the prior art of record, if rewritten to overcome the Double patenting rejection above. Claims 4-12 are allowable by virtue of their dependency.
Regarding claim 13:
Shalayev discloses a non-transitory computer readable storage medium storing a program that, when running on a computer that is connected with an associated medical imaging system comprising a laser that is adjustable relative to the gantry, causes the computer to perform steps comprising:
acquiring a fluoroscopic image of at least a part of bony structure of a patient from a viewing direction onto a patient ([0052], fluoroscopic image captured of bones);
receiving user input representing a virtual marker set at a first position in the fluoroscopic image (Fig. 3A-3B, 304, markers; [0030], user selects path);
outputting control parameters for:
controlling the laser to project an incision marker onto the patient in accordance with the virtual marker from a projection direction different from the viewing direction ([0041], lasers show incision path), wherein the incision marker is projected onto the patient at a first position on the patient in accordance with the virtual marker set at the first position in the fluoroscopic image ([0041], lasers show incision path).
Stoutenburgh teaches the gantry (Fig. 2a, 33) comprising a base (Fig. 2a, 40) and a ring (Fig. 2a, 61) carrying the x-ray detector (Fig. 2a, 32), wherein the x-ray detector is movable on the ring ([0019], detector rotation).
Kotian teaches wherein the laser and the x-ray detector are mutually attached for movement of the laser together with movement of the x-ray detector ([0064], detector rotates which means the lasers rotate with the detector),
moving the laser relative to the patient by moving the x-ray detector mutually attached with the laser along the ring to a second position of the x-ray detector on the ring([0064], detector rotates which means the lasers rotate with the detector), wherein the second position of the x-ray detector on the ring is different than the first position of the x-ray detector on the ring ([0064], detector rotates which means the detectors are at a different position).
However, Shalayev, Kotian, and Stoutenburg fail to teach acquiring a fluoroscopic image of at least a part of bony structure of a patient from a viewing direction onto a patient, the fluoroscopic image being captured by the x-ray detector disposed at a first position on the ring of the gantry; and with the x-ray detector disposed at the second position on the ring, controlling the laser to project the incision marker onto the patient from a projection direction different than the viewing direction.
Since the prior art of record fails to teach the details above, nor is there any reason to modify or combine prior art elements absent of applicant’s disclosure, the claim is deemed patentable over the prior art of record, if rewritten to overcome the Double patenting rejection above. Claims 14-16 are allowable by virtue of their dependency.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOORENA KEFAYATI whose telephone number is (469)295-9078. The examiner can normally be reached M to F, 7:30 am to 4:30 pm.
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/S.K./Examiner, Art Unit 2884
/DAVID J MAKIYA/Supervisory Patent Examiner, Art Unit 2884
