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 § 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2021/0244477 to Singh et al. in view of U.S. Patent Pub. No. 2021/0391058 to Kostrzewski et al.
As to Claim 1, Singh discloses a method (80) for remediating a condition present in a patient’s foot [0010, 0076]. The method comprises providing a deformity identifier (200) of a patient’s foot to a module [0080-0081], the module determining a preliminary cutting guide model configured to correct the deformity identified by the deformity identifier [0083-0084], and providing the preliminary cutting guide model configured to define a cutting guide (422) configured to remediate a condition present in a patient’s foot [0087-0088].
As to Claim 2, Singh discloses a method wherein the deformity identifier identifies a bunion deformity (143, deformities described in [0080]) and the method further comprises generating a cutting guide (422) based on the preliminary cutting guide model, the cutting guide (422) configured to remediate the deformity identified by the deformity identifier (model described in [0087-0089]).
As to Claim 3, Singh discloses a method wherein generating the cutting guide (422) comprises manufacturing a patient-specific cutting guide based on the preliminary cutting guide model [0089-0090].
As to Claim 4, Singh discloses a method further comprising providing anatomic data (141) of the patient’s foot to the module [0080-0081], and determining the deformity identifier (200) for the deformity by the module based on at least one of the anatomic data, a bone model (400), and a Computer Aided Design (CAD) model [0083-0085].
As to Claim 5, Singh discloses a method further comprising providing a plurality of input parameters to the module [0080], the module configured to use the input parameters to determine the deformity identifier [0081-0084].
As to Claim 6, Singh discloses a method wherein providing the preliminary cutting guide model comprises the module generating the preliminary cutting guide model [0082-0085].
As to Claim 7, Singh discloses a method providing the preliminary cutting guide model comprises the module selecting the preliminary cutting guide model from a set of template cutting guide models (cuts described in [0086], various guides corresponding to each described in [0088]).
As to Claim 8, Singh discloses a method further comprising the module determining at least one fixator to use in an osteotomy procedure planned for the patient’s foot and wherein the osteotomy procedure comprises the cutting guide configured to remediate a condition present in a patient’s foot (e.g. graft 442 described in [0105]).
As to Claim 9, Singh discloses a method (80) for remediating a condition present in a patient’s foot [0010, 0076]. The method comprises determining, by a module [0080-0081], a bunion deformity between a first metatarsal and a second metatarsal of a patient’s foot (143, deformities described in [0080]), the determined bunion deformity based on at least one of anatomic data (141), a bone model (400), and a Computer Aided Design (CAD) model [0083-0085], providing the determined bunion deformity to the module [0081-0084], selecting, by a module, a preliminary cutting guide model from a set of template cutting guide models (cuts described in [0086], various guides corresponding to each described in [0088]), the preliminary cutting guide model configured to correct the determined bunion deformity [0086-0088], and generating a cutting guide (422) based on the selected preliminary cutting guide model [0088-0091].
As to Claim 10, Singh discloses a method wherein the bone model comprises a bone model of at least the first metatarsal and the second metatarsal of the patient’s foot [0080, 0084, 0118-0119].
As to Claim 11, Singh discloses a method wherein generating the cutting guide comprises modifying the selected the preliminary cutting guide model to form a patient-specific cutting guide model that is used to generate the cutting guide [0089].
As to Claim 12, Singh discloses a method wherein generating the cutting guide comprises manufacturing a patient-specific cutting guide (422) based on the selected the preliminary cutting guide model [0088-0090].
As to Claim 13, Singh discloses a method wherein generating the cutting guide (422) comprises determining a contour of bones that will contact (at 425) the preliminary cutting guide model [0090], the contour based on at least one of a bone model of the bones and anatomic data of the patient [0090], applying the contour to the selected preliminary cutting guide model to contour a bone apposition side of the selected preliminary cutting guide model [0089-0090].
As to Claim 14, Singh discloses a method further comprising modifying the selected preliminary cutting guide model to include one or more modifications provided by a user [0089].
As to Claim 15, Singh discloses a method further comprising an artificial intelligence module determining at least one fixator to use in an osteotomy procedure planned for the patient’s foot (e.g. graft 442 described in [0105]) and wherein the osteotomy procedure comprises the cutting guide (422) configured to remediate a condition present in a patient’s foot [0090-0092].
As to Claim 16, Singh discloses a non-transitory computer-readable medium storing a set of instructions [0077] for remediating a condition present in a patient’s foot [0010, 0076]. The set of instructions comprising one or more instructions that, when executed by one or more processors of a device, cause the device to, by a module [0080-0081], the determined deformity based on a bone model comprising bone models of at least the first metatarsal and the second metatarsal of the patient’s foot (143, deformities described in [0080]), provide the determined deformity to the module [0081-0084], select, by the module, a preliminary cutting guide model from a set of template cutting guide models (cuts described in [0086], various guides corresponding to each described in [0088]), the preliminary cutting guide model configured to correct the determined deformity of the first metatarsal in relation to the second metatarsal [0086-0088], and generate a cutting guide (422) based on the selected preliminary cutting guide model [0088-0091].
As to Claim 17, Singh discloses a non-transitory computer-readable medium wherein the one or more instructions that cause the device to generate the cutting guide (422), cause the device to modify the selected the preliminary cutting guide model to form a patient-specific cutting guide model that is used to generate the cutting guide [0084].
As to Claim 18, Singh discloses a non-transitory computer-readable medium wherein the one or more instructions that cause the device to generate the cutting guide (422), cause the device to manufacture a patient-specific cutting guide based on the selected the preliminary cutting guide model [0088-0090].
As to Claim 19, Singh discloses a non-transitory computer-readable medium wherein the one or more instructions, when generating the cutting guide (422), cause the device to determine a contour of bones of the patient that will contact (at 425) the preliminary cutting guide model [0090], the contour based on the bone model [0090], and apply the contour to the selected preliminary cutting guide model to contour a bone apposition side of the selected preliminary cutting guide model [0089-0090].
As to Claim 20, Singh discloses a non-transitory computer-readable medium wherein the one or more instructions further cause the device to: modify the selected preliminary cutting guide model to include one or more modifications provided by a user [0089].
As to Claims 1-20, Singh discloses the claimed invention except for wherein the module is an artificial intelligence module, providing anatomic data of the patient’s foot to the artificial intelligence module, providing a plurality of input parameters to the artificial intelligence module, the artificial intelligence module configured to use the input parameters to determine the deformity identifier, wherein providing the preliminary cutting guide model comprises the artificial intelligence module generating the preliminary cutting guide model.
Kostrzewski discloses a surgical method [0009] including the use of an artificial intelligence module (1300, [0158, 0162, 0177-0179]) in order to assist in determining a correction plan for the patient [0177-0179]. The method includes providing anatomic data of the patient’s bone to the artificial intelligence module (1200-1204, [0159]), providing a plurality of input parameters to the artificial intelligence module (1200-1204, [0159]), the artificial intelligence module configured to use the input parameters to determine the deformity identifier [0162], wherein providing the preliminary cutting guide model comprises the artificial intelligence module generating the preliminary cutting guide model [0177-0179] in order to provide means for increasing accuracy in creating a custom guide for improved patient outcomes post-surgery [0158].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the surgical method of Singh with the artificial intelligence module modification of Kostrzewski in order to provide means for increasing accuracy in creating a custom guide for improved patient outcomes post-surgery.
Conclusion
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775