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 Objections
Claims 1, 2 and 7 are objected to because of the following informalities:
Claim 1, line 1: --a-- should be added between “in” and “patient”.
Claim 1, line 13: --an-- should be added before “orientation”.
Claim 2, line 1: --a-- should be added between “in” and “patient”.
Claim 2, line 6: “a” (between “comprises” and “computing”) should be changed to --the--.
Claim 2, line 11: “an” (between “recording” and “image”) should be removed.
Claim 2, line 16: --an-- should be added between “recording” and “orientation”.
Claim 7, line 2: --a-- should be added between “or” and “portion”.
Appropriate correction is required.
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.
Claims 1-8 are 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 1 recites the limitation "the location" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the joint" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the orientation" in line 14. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the location" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the joint" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the anatomy" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation “the one or more anatomic features” in line 15. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the orientation" in line 18. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the indication" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Stein et al., U.S. PG-Pub 2014/0135616.
Regarding claim 1, Stein et al. discloses a method of implanting a prosthesis in a patient undergoing a joint arthroplasty using a surgical navigation system, wherein the surgical navigation system comprises: a handheld surgical tool (2500) with computer-aided navigation (via sensor 2006), wherein the handheld surgical tool comprises a handle (2406) and an instrument shaft (2408) (Fig. 6A); a graphical user interface (GUI) module executed by a computing device, wherein the GUI module comprises a visual display (2016) that is configured to indicate a location of the handheld surgical tool (Figs. 3-4); and an imaging device (paragraph [0084]); the method comprising: exposing a joint (2204) of the joint arthroplasty; placing a marker (2223) on anatomical features of the joint; engaging the handheld surgical tool with the marker and recording (as seen on display 2016) an orientation of the handheld surgical tool during the engagement; registering the orientation of the handheld surgical tool relative to an orientation of the joint (see “probe orientation” on display 2016); displaying the orientation of the handheld surgical tool and a predetermined target orientation for the handheld surgical tool and the visual display (Fig. 3 and paragraph [0160]); and implanting the prosthesis using the handheld surgical tool and the visual display, wherein the orientation of the handheld surgical tool is adjusted according to the predetermined target orientation for the handheld surgical tool (Fig. 4 and paragraph [0161]).
Regarding claim 2, Stein et al. discloses a method of implanting a prosthesis in a patient undergoing a joint arthroplasty using a surgical navigation system, wherein the surgical navigation system comprises: a handheld surgical tool (2500) with computer-aided navigation (via sensor 2006), wherein the handheld surgical tool comprises a handle (2406) and an instrument shaft (2408) (Fig. 6A); a graphical user interface (GUI) module executed by a computing device, wherein the GUI module comprises the computing device and a visual display (2016) that is configured to indicate a location of the handheld surgical tool (Figs. 3-4); and an imaging device (paragraph [0084]); the method comprising: exposing a joint (2204) of the joint arthroplasty; recording image data of anatomy of the joint, or a portion thereof, using the imaging device; generating three-dimensional image or contour of the anatomy of the joint, or the portion thereof, using the GUI module (as seen on display 2016); engaging the handheld surgical tool with one or more anatomic features on the joint and recording an orientation of the handheld surgical tool during the engagement; registering the orientation of the handheld surgical tool relative to an orientation of the joint (see “probe orientation” on display 2016); displaying a three-dimensional image/contour, the orientation of the handheld surgical tool, and a predetermined target orientation for the handheld surgical tool, on the visual display (Fig. 3 and paragraph [0160]); and implanting the prosthesis using the handheld surgical tool and the visual display, wherein the orientation of the handheld surgical tool is adjusted according to the predetermined target orientation for the handheld surgical tool (Fig. 4 and paragraph [0161]).
Regarding claims 3 and 4, Stein et al. discloses wherein the handle (2406) comprises a processor and a sensor unit (2006) (Fig. 5 and paragraph [0162]); and wherein the sensor unit comprises a 3-axis accelerometer, a 3-axis rate gyroscope, a 3-axis magnetometer, or a combination thereof (paragraphs [0058] and [0071]).
Regarding claims 5 and 6, Stein et al. discloses wherein the sensor unit is configured to generate orientational data of the handheld surgical tool, and the processor or the computing device is configured to determine, based on the orientational data, the orientation of the handheld surgical tool and compare the orientation of the handheld surgical tool with at least one preset target orientation (paragraph [0332]); and wherein the visual display (2016) is configured to indicate a deviation of the orientation of the handheld surgical tool from the at least one preset target orientation (via the +/- degree orientation) (Figs. 3-4).
Regarding claims 7 and 8, Stein et al. further comprises generating a three-dimensional image or contour of a surface of the patient’s anatomy or a portion thereof for display in conjunction with an indication of the location of the handheld surgical tool (Figs. 3-4 and paragraph [0160]); and wherein the joint arthroplasty is a hip arthroplasty (Figs. 33-34A) or a knee arthroplasty (Figs. 1-2).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571) 272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC S GIBSON/ Primary Examiner, Art Unit 3775