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
A series of singular dependent claims is permissible in which a dependent claim refers to a preceding claim which, in turn, refers to another preceding claim.
A claim which depends from a dependent claim should not be separated by any claim which does not also depend from said dependent claim. It should be kept in mind that a dependent claim may refer to any preceding independent claim. In general, applicant's sequence will not be changed. See MPEP § 608.01(n).
Claims 15, 16, 17, and 18 are objected to because of the following informalities: because Claims 15, 16, 17, and 18 are depending on non-existing claim 21.
For purpose of compact prosecution, claims 15, 16, 17, and 18 will be treated as if it were depending from Claim 1.
Appropriate correction is required.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,903,655 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because application claims 1-20 are anticipated by claims 1-20 of the patent, and it is not patentably distinct from claims 1-20 of the patent. Please, see the Table as shown below:
Under Examination Claims
Patented Claims
1. A method comprising:
obtaining at least one image of a subject;
obtaining, from the at least one image, a set of anatomical positions of at least two vertebrae of the subject;
determining a model of the subject based on the set of anatomical positions, wherein the model defines a sagittal curvature profile, a coronal curvature profile, and one or more spinal parameters;
receiving one or more simulated spinal correction inputs corresponding to a surgical procedure;
predicting a simulated postoperative surgical correction for the subject based on the one or more simulated spinal correction inputs and the model;
determining a surgical plan for the subject based on the simulated postoperative surgical correction; providing the surgical plan via a display;
designing a simulated spinal implant for use in conjunction with the simulated postoperative surgical correction;
manufacturing a personalized spinal implant configured to be implanted in the subject, the manufacturing being based on the simulated spinal implant; and
providing the personalized spinal implant for implantation into the subject.
Anticipated by patented claim 1:
1. A method comprising:
obtaining at least one image of a subject, wherein the at least one image is any of (i) an X-ray image, (ii) a computed tomography image, (iii) a magnetic resonance imaging image, (iv) a biplanar X-ray image, or (v) any combination of (i)-(iv);
obtaining, from the at least one image, a set of anatomical positions of at least two vertebrae of the subject;
determining a model of the subject based on the set of anatomical positions, wherein the model defines a sagittal curvature profile, a coronal curvature profile, and one or more spinal parameters;
receiving one or more simulated spinal correction inputs corresponding to a surgical procedure;
predicting a simulated postoperative surgical correction for the subject based on the one or more simulated spinal correction inputs and the model;
determining a surgical plan for the subject based on the simulated postoperative surgical correction;
providing the surgical plan via a display;
designing a simulated spinal implant for use in conjunction with the simulated postoperative surgical correction;
manufacturing a personalized spinal implant configured to be implanted in the subject, the manufacturing being based on the simulated spinal implant; and
providing the personalized spinal implant for implantation into the subject.
2. The method of claim 1, wherein obtaining, from the at least one image, the set of anatomical positions of the at least two vertebrae of the subject includes: receiving digitized positions that correspond to at least one position on each of the at least two vertebrae in the at least one image.
Anticipated by patented claim 2:
2. The method of claim 1, wherein obtaining, from the at least one image, the set of anatomical positions of the at least two vertebrae of the subject includes: receiving digitized positions that correspond to at least one position on each of the at least two vertebrae in the at least one image.
3. The method of claim 1, wherein the simulated postoperative surgical correction maintains a center of mass of the subject over the ankles of the subject.
Anticipated by patented claim 3:
3. The method of claim 1, wherein the simulated postoperative surgical correction maintains a center of mass of the subject over the ankles of the subject.
4. The method of claim 1, further comprising: calculating an optimized posture for the subject based on a comparison of the model and one or more predetermined models.
Anticipated by patented claim 4:
4. The method of claim 1, further comprising: calculating an optimized posture for the subject based on a comparison of the model and one or more predetermined models.
5. The method of claim 1, wherein predicting the simulated postoperative surgical correction includes predicting one or both of (v) postoperative muscle force data and (vi) postoperative muscle activation data.
Anticipated by patented claim 5:
5. The method of claim 1, wherein predicting the simulated postoperative surgical correction includes predicting one or both of (v) postoperative muscle force data and (vi) postoperative muscle activation data.
6. The method of claim 1, wherein the at least one image is of the subject in a standing lateral position.
Anticipated by patented claim 6:
6. The method of claim 1, wherein the at least one image is of the subject in a standing lateral position.
7. The method of claim 1, wherein designing the simulated spinal implant includes receiving input from a user for a location and a size of the simulated spinal implant.
Anticipated by patented claim 7:
7. The method of claim 1, wherein designing the simulated spinal implant includes receiving input from a user for a location and a size of the simulated spinal implant.
8. The method of claim 1, wherein the obtaining the set of anatomical positions of a patient from the at least one image includes applying image recognition software to the at least one image.
Anticipated by patented claim 8:
8. The method of claim 1, wherein the obtaining the set of anatomical positions of a patient from the at least one image includes applying image recognition software to the at least one image.
9. The method of claim 1, wherein the model is a musculoskeletal model.
Anticipated by patented claim 9:
9. The method of claim 1, wherein the model is a musculoskeletal model.
10. The method of claim 1, wherein determining the model comprises using inverse-inverse dynamics modeling.
Anticipated by patented claim 10:
10. The method of claim 1, wherein determining the model comprises using inverse-inverse dynamics modeling.
11. The method of claim 1, wherein the model includes joint kinematics.
Anticipated by patented claim 11:
11. The method of claim 1, wherein the model includes joint kinematics.
12. The method of claim 1, wherein predicting the simulated postoperative surgical correction includes a prediction of simulated anterior lumbar interbody fusion surgery.
Anticipated by patented claim 12:
12. The method of claim 1, wherein predicting the simulated postoperative surgical correction includes a prediction of simulated anterior lumbar interbody fusion surgery.
13. The method of claim 1, wherein the one or more simulated spinal correction inputs includes at least one of sagittal alignment and muscle recruitment criteria.
Anticipated by patented claim 13:
13. The method of claim 1, wherein the one or more simulated spinal correction inputs includes at least one of sagittal alignment and muscle recruitment criteria.
14. The method of claim 1, further comprising: outputting a value, based on the simulated postoperative surgical correction, corresponding to a variance from an optimal posture.
Anticipated by patented claim 14:
14. The method of claim 1, further comprising: outputting a value, based on the simulated postoperative surgical correction, corresponding to a variance from an optimal posture.
15. The method of claim 21, further comprising: providing a classification of the surgical plan as representing an overcorrection or an undercorrection.
Anticipated by patented claim 15:
15. The method of claim 1, further comprising: providing a classification of the surgical plan as representing an overcorrection or an undercorrection.
16. The method of claim 21, further comprising: receiving a modification of the surgical plan; modifying the surgical plan based on the modification to form a modified surgical plan; and providing the modified surgical plan via the display.
Anticipated by patented claim 16:
16. The method of claim 1, further comprising: receiving a modification of the surgical plan; modifying the surgical plan based on the modification to form a modified surgical plan; and providing the modified surgical plan via the display.
17. The method of claim 21, wherein the one or more spinal parameters include one or more parameters selected from the group consisting of: a pelvic tilt value, a pelvic incidence value, a sagittal vertical axis value, and a lumbar lordosis value.
Anticipated by patented claim 17:
17. The method of claim 1, wherein the one or more spinal parameters include one or more parameters selected from the group consisting of: a pelvic tilt value, a pelvic incidence value, a sagittal vertical axis value, and a lumbar lordosis value.
18. The method of claim 21, further comprising, implanting the personalized spinal implant in the subject.
Anticipated by patented claim 18:
18. The method of claim 1, further comprising, implanting the personalized spinal implant in the subject.
19. A method comprising:
obtaining at least one image of a subject;
obtaining, from the at least one image, a set of anatomical positions of at least two vertebrae of the subject;
determining a musculoskeletal model of a subject based on the set of anatomical positions, wherein the musculoskeletal model defines muscle force data, a sagittal curvature profile, a coronal curvature profile, and one or more spinal parameters;
receiving one or more simulated spinal correction inputs corresponding to a surgical procedure;
predicting a simulated postoperative surgical correction for the subject based on the received one or more simulated spinal correction inputs and the musculoskeletal model; providing the determined surgical plan via a display; communicating muscle force data associated with the determined surgical plan to a user;
determining a surgical plan for the subject based on the predicted simulated postoperative surgical correction;
designing a simulated spinal implant for use in conjunction with the simulated postoperative surgical correction;
manufacturing a personalized spinal implant configured to be implanted in the subject, the manufacturing being based on the designed simulated implant; and
providing the personalized spinal implant for implantation into the subject.
Anticipated by patented claim 19:
19. A method comprising:
obtaining at least one image of a subject, wherein the at least one image is an X-ray image, a computed tomography image, a magnetic resonance imaging image, or a biplanar X-ray image;
obtaining, from the at least one image, a set of anatomical positions of at least two vertebrae of the subject;
determining a musculoskeletal model of a subject based on the set of anatomical positions, wherein the musculoskeletal model defines muscle force data, a sagittal curvature profile, a coronal curvature profile, and one or more spinal parameters;
receiving one or more simulated spinal correction inputs corresponding to a surgical procedure;
predicting a simulated postoperative surgical correction for the subject based on the received one or more simulated spinal correction inputs and the musculoskeletal model; providing the determined surgical plan via a display; communicating muscle force data associated with the determined surgical plan to a user;
determining a surgical plan for the subject based on the predicted simulated postoperative surgical correction;
designing a simulated spinal implant for use in conjunction with the simulated postoperative surgical correction;
manufacturing a personalized spinal implant configured to be implanted in the subject, the manufacturing being based on the designed simulated implant; and
providing the personalized spinal implant for implantation into the subject.
20. A method comprising:
obtaining at least one image of a subject;
obtaining, from the at least one image, a set of anatomical positions of at least two vertebrae of the subject;
determining a model of the subject based on the set of anatomical positions, wherein the model defines a sagittal curvature profile, a coronal curvature profile, and one or more spinal parameters;
receiving one or more simulated spinal correction inputs corresponding to a surgical procedure;
predicting an effect the surgical procedure will have on a postoperative posture of the subject;
providing the determined surgical plan via a display;
determining a surgical plan for the subject based on the predicted effect of the surgical procedure on the postoperative posture of the subject;
designing a simulated spinal implant for use in conjunction with the surgical procedure;
manufacturing a personalized spinal implant configured to be implanted in the subject, the manufacturing being based on the designed simulated implant; and
providing the personalized spinal implant for implantation into the subject.
Anticipated by patented claim 20:
20. A method comprising:
obtaining at least one image of a subject, wherein the at least one image is an X-ray image, a computed tomography image, a magnetic resonance imaging image, or a biplanar X-ray image;
obtaining, from the at least one image, a set of anatomical positions of at least two vertebrae of the subject;
determining a model of the subject based on the set of anatomical positions, wherein the model defines a sagittal curvature profile, a coronal curvature profile, and one or more spinal parameters;
receiving one or more simulated spinal correction inputs corresponding to a surgical procedure;
predicting an effect the surgical procedure will have on a postoperative posture of the subject;
providing the determined surgical plan via a display;
determining a surgical plan for the subject based on the predicted effect of the surgical procedure on the postoperative posture of the subject;
designing a simulated spinal implant for use in conjunction with the surgical procedure;
manufacturing a personalized spinal implant configured to be implanted in the subject, the manufacturing being based on the designed simulated implant; and
providing the personalized spinal implant for implantation into the subject.
Allowable Subject Matter
Claims 1-20 are allowed if the above Doble Patenting rejection and claim objection overcomes.
The following is an examiner’s statement of reasons for allowance:
The primary reason for the allowance of the claim is the inclusion of the limitation “manufacturing a personalized spinal implant configured to be implanted in the subject, the manufacturing being based on the simulated spinal implant; and
providing the personalized spinal implant for implantation into the subject” as recited in independent claim 1, in all of the claims which is not found in the prior art references.
Claims 2-18 are allowed for the same reasons as claim 1, from which they depend.
The primary reason for the allowance of the claim is the inclusion of the limitation “manufacturing a personalized spinal implant configured to be implanted in the subject, the manufacturing being based on the designed simulated implant; and
providing the personalized spinal implant for implantation into the subject” as recited in independent claim 19, in all of the claims which is not found in the prior art references.
The primary reason for the allowance of the claim is the inclusion of the limitation “manufacturing a personalized spinal implant configured to be implanted in the subject, the manufacturing being based on the designed simulated implant; and
providing the personalized spinal implant for implantation into the subject” as recited in independent claim 20, in all of the claims which is not found in the prior art references.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BITEW A DINKE whose telephone number is (571)272-0534. The examiner can normally be reached M-F 7 a.m. - 5 p.m..
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/BITEW A DINKE/Primary Examiner, Art Unit 2812