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 .
EXAMINER’S COMMENT
The amendment submitted on 10/30/2024 has been entered and will be examined in this paper.
There does not appear to be any overlapping subject matter requiring a Double Patenting over US Patent 12127769 at this time.
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.
Claim(s) 92-94 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Frey (US 20180271602).
With respect to claim 92, Frey discloses a method for treating a patient in an operative setting (see abstract, para. 25-26, 29), comprising: obtaining patient data in the operative setting (see fig. 39); manually bending a rod using a tool during a patient operation in the operative setting (see para. 377), wherein the rod is configured to be attached to a plurality of spine segments of the patient (see para. 29); after obtaining the patient data and bending the rod, comparing the rod to a patient-specific plan in the operative setting (see para. 25-26, 29 and fig. 39 below), wherein the patient-specific plan is generated based at least in part on the patient data (see fig. 39 below, steps 2708, 2712, 2716) and includes a preidentified desired contour for the rod (see fig. 39 below, step 2716); in response to the rod complying with the patient-specific plan, proceeding with the patient operation (see fig. 39 below, steps 2732, 2740, 2744); and in response to the rod not complying with the patient-specific plan, repeating the operations of manually bending and comparing until the rod complies with the patient-specific plan (see fig. 39 below and steps 2732, 2736, 2740, 2744).
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As for claim 93, Frey, further discloses the method of claim 92 wherein comparing the rod to the patient-specific plan includes: accessing a patient-specific jig (e.g., template 2602) manufactured based on the patient-specific plan (see fig. 39 above, steps 2720, fig. 37b below), wherein the patient-specific jig includes an inner contour guide (e.g., 2608) corresponding to the preidentified contour for the rod (see para. 393); placing the rod against the inner contour guide of the patient-specific jig using a proper orientation of the rod relative to the patient-specific jig (see para. 395); and confirming by visual and physical inspection whether the rod conforms to a contoured shape of the inner contour guide (see para. 395 and also fig. 39 above, step 2732).
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As for claim 94 method of claim 92 wherein comparing the rod to the patient-specific plan includes: accessing a virtual model associated with the patient-specific plan (see para. 194, 362-363, fig. 39 above), the virtual model showing a corrected anatomical configuration for the plurality of spine segments of the patient (see para. 194, 362-363, 366-367and 393, fig. 39 above); and comparing the rod to the corrected anatomical configuration (see para. 401, fig. 39 above).
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(s) 45-48 and 91 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hobeika (WO 2018203100A1) in view of Scholl (US 20170135770).
With respect to claim 45, Hobeika teaches a method for using a patient-specific jig (e.g., tool 20) to confirm a correct contour of a fixation element (e.g., spinal correction rod implant) in an operative setting (see page 14 lines 1-16 below, specifically lines 7-11), the method comprising the steps of: accessing the patient-specific jig in the operative setting (see page 14 lines 1-16 below, specifically lines 7-11); placing the fixation element against an inner contour guide (21) of the patient-specific jig using proper orientation of the fixation element relative to the patient-specific jig (see page 14 lines 1-16 below); and confirming by visual and physical inspection whether the fixation element conforms to a contoured shape of the inner contour guide of the patient-specific jig (see page 14 lines 1-16 below, specifically, lines 7-11).
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Hobeika does teach assessing whether the fixation element requires further bending, but does not appear to specifically teach the step of manually bending the fixation element using a tool during a patient operation in the operative setting.
Scholl, also drawn to methods to assessing and bending fixation elements (e.g., rods, see para. 7, 134, 151), teaches that bending a fixation element (rod) manually using a tool (see para. 7, 134, 151) during a patient operation in the operative setting (see para. 7) in order to provide a known method of bending/contouring the rod as needed by surgical plan (see para. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Hobeika to include manually bending the fixation element using a tool during a patient operation in the operative setting, in view of Scholl, in order to provide a known method of bending/contouring the rod as needed by surgical plan.
As for claim 46, Hobeika, as modified by Scholl, further teaches the method of claim 45 wherein the patient-specific jig is provided on a flat surface (see fig. 5 above and note that 20 is a plate with a flat back surface, also see fig. 6b and accompanying text for an example of a flat back surface) in the operative setting with the inner contour guide of the patient-specific jig facing up (see fig. 5 above).
As for claim 47, Hobeika, as modified by Scholl, further teaches the method of claim 45 wherein the patient-specific jig has a front surface (e.g., top surface) in which the inner contour guide is formed (see fig. 5-6a above).
As for claim 48, Hobeika, as modified by Scholl, further teaches the method of claim 47 wherein the front surface includes a top position marking (e.g. at 22, see fig. 5 above) to assist in the proper orientation of the fixation element relative to the patient-specific jig.
As for claim 91, Hobeika, as modified by Scholl, further teaches the method of claim 45 wherein the fixation element is a rod (spinal correction rod implant, see page 14 lines 1-16 above).
Claim(s) 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hobeika (WO 2018203100A1) and Scholl (US 20170135770), as applied to claim 47 above, in view of Frey (US 20180271602) in view of Garcia- Bengochea (US 20110184473).
As for claim 49, Hobeika, as modified by Scholl, does not teach wherein a plurality of bone anchor position indicators are provided on the front surface and wherein the method further includes the step of making a mark on the fixation element corresponding to each of the bone anchor position indicators.
Frey, also drawn to methods to assessing and bending fixation elements (e.g., rods, see abstract and fig. 39), further teaches a template (e.g., see fig. 35a-35e and 37a-37b) wherein a plurality of bone anchor position indicators are provided on the front surface (e.g., see fig. 35a-35e and 37a-37b, para. 378-380, 391-396, note that “purpose of the rod” in lines 2-3 of para. 396 is indicative of bone anchor location as described in para. 378-380 and 391-396) in order to duplicate and indicate the pre-surgically planned screw trajectory for a specific patient on the patient-specific jig (template) (see para. 395-396).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hobeika, as modified by Scholl, wherein a plurality of bone anchor position indicators are provided on the front surface, in view of Frey, as a matter of engineering design choice, in order to duplicate and indicate the pre-surgically planned screw trajectory for a specific patient on the patient-specific jig (template).
Garcia- Bengochea, also drawn to patient-specific jigs for fixation elements (spinal rods) (see para. 31-32), teaches the step of making a mark (e.g., 92) on the fixation element corresponding to a desired indicator (see para 32) in order to provide the surgeon with pertinent information regarding the patient-specific jig using a known visual aid (see para. 32).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hobeika, as modified by Scholl and Frey, wherein the method further includes the step of making a mark on the fixation element corresponding to each of the bone anchor position indicators, in view of Garcia- Bengochea, in order to provide the surgeon with pertinent information regarding the patient-specific jig using a known visual aid.
Claim(s) 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hobeika (WO 2018203100A1), Scholl (US 20170135770), Frey (US 20180271602) and Garcia- Bengochea (US 20110184473), as applied to claim 49 above, in view of Graf (US 5306301).
As for claim 50, Hobeika, as modified by Scholl, Frey and Garcia- Bengochea, does not teach wherein each mark is made on the fixation element using a surgical marker.
Graf, also drawn to surgical implants, teaches using a surgical marker to mark a fixation element (e.g., graft) in order to indicate to the surgeon information pertinent to the fixation element (see col. 5 lines 25-36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hobeika, as modified by Scholl, Frey and Garcia- Bengochea, wherein each mark is made on the fixation element using a surgical marker, in view of Graf, in order to indicate to the surgeon information pertinent to the fixation element with a known marking implement.
Claim(s) 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hobeika (WO 2018203100A1), Scholl (US 20170135770), Frey (US 20180271602) and Garcia- Bengochea (US 20110184473), as applied to claim 49 above, in view of Smisson (US 20110224740).
As for claim 51, Hobeika, as modified by Scholl, Frey and Garcia- Bengochea, does not teach wherein each mark is made on the fixation element using a surgical marker.
Smisson, also drawn to surgical implants, teaches using a laser etch to mark a fixation element (e.g., 1162 or 1164) in order to indicate to the surgeon information pertinent to the fixation element (see para. 150).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Hobeika, as modified by Scholl, Frey and Garcia- Bengochea, wherein each mark is made on the fixation element using a surgical marker, in view of Smisson, in order to indicate to the surgeon information pertinent to the fixation element with a known marking implement.
Claim(s) 95, 96 and 100 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frey (US 20180271602), as applied to claims 92 and 94 above, in view of Scholl (US 20170135770).
As for claims 95 and 96, Frey does not appear to teach wherein the virtual model includes a digital representation of a rod having the preidentified desired contour; and further comprising: in response to the rod not complying with the corrected anatomical configuration, updating the virtual model to show a new predicted corrected anatomical configuration.
Scholl, also drawn to a method for treating a patient in an operative setting, teaches wherein the virtual model includes a digital representation of a rod having the preidentified desired contour (see abstract and para. 9-10, 129); and further comprising: in response to the rod not complying with the corrected anatomical configuration, updating the virtual model to show a new predicted corrected anatomical configuration (para. 129-130) in order to allow the surgeon to plan, perform and assess surgical correction during a spinal procedure, as is known in this field of endeavor (see abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Frey to include wherein the virtual model includes a digital representation of a rod having the preidentified desired contour; and further comprising: in response to the rod not complying with the corrected anatomical configuration, updating the virtual model to show a new predicted corrected anatomical configuration, in view of Scholl, in order to allow the surgeon to plan, perform and assess surgical correction during a spinal procedure, as is known in this field of endeavor.
As for claim 100, Frey does not appear to teach the method further comprising: in response to the rod not complying with the patient-specific plan, providing one or more instructions to guide further bending of the rod before repeating the operations of manually bending and comparing.
Scholl, also drawn to a method for treating a patient in an operative setting (see abstract), teaches the step of in response to the rod not complying with the patient-specific plan, providing one or more instructions to guide further bending of the rod before repeating the operations of manually bending and comparing (see para. 128) in order to provide the surgeon with the ability to appropriately plan, perform and assess surgical correction during a spinal procedure, as is known in this field of endeavor (see abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Frey with the method further comprising: in response to the rod not complying with the patient-specific plan, providing one or more instructions to guide further bending of the rod before repeating the operations of manually bending and comparing, in view of Scholl, in order to provide the surgeon with the ability to appropriately plan, perform and assess surgical correction during a spinal procedure, as is known in this field of endeavor.
Claim(s) 97, 98, 101-103 and 105 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frey (US 20180271602), as applied to claim 94 above, in view of Mosnier (US 20200315708).
As for claims 97-98, Frey does not appear to teach wherein comparing the rod to the patient-specific plan includes: accessing a machine learning model trained on surgery outcomes of spinal rod implants; and evaluating, via the machine learning model, a likelihood of achieving the corrected anatomical configuration using the rod; and wherein evaluating the likelihood of achieving the corrected anatomical configuration is further based on predicting one or more of stress, strain, load deformation, fracture toughness, and/or fatigue life of the rod. Mosnier, also drawn to a method for treating a patient in an operative setting, teaches wherein comparing the rod to the patient-specific plan includes: accessing a machine learning model trained on surgery outcomes of spinal rod implants (see para. 145); and evaluating, via the machine learning model, a likelihood of achieving the corrected anatomical configuration using the rod (see para. 144-145); and wherein evaluating the likelihood of achieving the corrected anatomical configuration is further based on predicting one or more of stress, strain, load deformation, fracture toughness, and/or fatigue life of the rod (see para. 112 and note the “previous surgical outcomes and/or one or more parameters of previously implanted rods or other implants to predict, design, develop and/or plan patient spinal rods”, i.e., load deformation) in order to augment a patient-specific spinal procedure by providing a patient specific spinal treatment that uses predictive modeling to predict the outcome of the procedure (see abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Frey wherein comparing the rod to the patient-specific plan includes: accessing a machine learning model trained on surgery outcomes of spinal rod implants; and evaluating, via the machine learning model, a likelihood of achieving the corrected anatomical configuration using the rod; and wherein evaluating the likelihood of achieving the corrected anatomical configuration is further based on predicting one or more of stress, strain, load deformation, fracture toughness, and/or fatigue life of the rod, in view of Mosnier, in order to augment a patient-specific spinal procedure by providing a patient specific spinal treatment that uses predictive modeling to predict the outcome of the procedure. With respect to claim 101, Frey teaches a method for treating a patient, the method comprising: bending a rod configured to be attached to a plurality of spine segments in accordance with a patient-specific preoperative plan (see fig. 39 above, para. 25-26), wherein the patient-specific preoperative plan includes a corrected anatomical configuration for the plurality of spine segments and a preidentified desired contour for the rod for achieving the corrected anatomical configuration (see fig. 39 above, step 2716); after bending the rod, comparing the rod to the preidentified desired contour for the rod (see fig. 39 above); and in response to the likelihood meeting an acceptable threshold, proceeding with a surgical operation in accordance with the patient-specific surgical plan (see fig. 39 above, step 2732, 2740, 2744); and in response to the likelihood not meeting the acceptance threshold, repeating the operations of bending, comparing, and evaluating (see fig. 39 below and steps 2732, 2736, 2740, 2744).
Frey does not teach evaluating, using a machine learning model trained on surgical outcomes of other surgeries to implant spinal rods in other patients, a likelihood of achieving the predicted surgical outcome associated with the patient-specific preoperative plan based at least in part on a conformity of the rod to the preidentified desired contour for the rod.
Mosnier, also drawn to a teaches a method for treating a patient, teaches using a machine learning model trained on surgical outcomes of other surgeries to implant spinal rods in other patients, a likelihood of achieving the predicted surgical outcome associated with the patient-specific preoperative plan based at least in part on a conformity of the rod to the preidentified desired contour for the rod (see para. 145-146 and para. 112, and note the “previous surgical outcomes and/or one or more parameters of previously implanted rods or other implants to predict, design, develop and/or plan patient spinal rods”, i.e., load deformation) in order to augment a patient-specific spinal procedure by providing a patient specific spinal treatment that uses predictive modeling to predict the outcome of the procedure (see abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Frey to include evaluating, using a machine learning model trained on surgical outcomes of other surgeries to implant spinal rods in other patients, a likelihood of achieving the predicted surgical outcome associated with the patient-specific preoperative plan based at least in part on a conformity of the rod to the preidentified desired contour for the rod, in view of Mosnier, in order to augment a patient-specific spinal procedure by providing a patient specific spinal treatment that uses predictive modeling to predict the outcome of the procedure.
As for claim 102, Frey, as modified by Mosnier, further teaches the method of claim 101 wherein comparing the rod to the patient-specific preoperative plan includes: accessing a patient-specific jig (e.g., template 2602, see fig. 37b above) manufactured based on the patient-specific preoperative plan (see fig. 39 above), wherein the patient-specific jig includes an inner contour guide (e.g., 2608) corresponding to the preidentified contour for the rod (see fig. 37b above); placing the rod against the inner contour guide of the patient-specific jig using a proper orientation of the rod relative to the patient-specific jig (see fig. 39 above); and confirming by visual and physical inspection whether the rod conforms to a contoured shape of the inner contour guide (see fig. 39 above).
As for claim 103, Frey, as modified by Mosnier, further teaches the method of claim 101 wherein comparing the rod to the patient-specific preoperative plan includes: accessing a virtual model associated with the patient-specific preoperative plan (see para. 194, 362-363, fig. 39 above), the virtual model showing a corrected anatomical configuration for the plurality of spine segments of the patient and a digital representation of a rod having the preidentified desired contour (see para. 194, 362-363, 366-367 and 393, see fig. 39 above); and comparing the rod to the virtual model (see para. 401, fig. 39 above).
As for claim 105, Frey, as modified by Mosnier, further teaches the method of claim 101 wherein bending the rod includes manually bending the rod using a tool (see fig. 39 below and steps 2732, 2736, 2740, 2744).
Claim(s) 99 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frey (US 20180271602), as applied to claims 94 above, in view of Saget (US 20190122330).
As for claim 99, Frey does not appear to teach wherein comparing the rod to the patient-specific plan includes determining, in real-time or in near real-time, a risk score for the patient using a machine learning model.
Saget, also drawn to a method for treating a patient in an operative setting (see abstract), teaches wherein comparing the rod to the patient-specific plan includes determining, in real-time or in near real-time, a risk score for the patient using a machine learning model (see para. 4, 75) in order to allow the surgeon to predict problems and provide guidance in real-time situations (see para. 75).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Frey wherein comparing the rod to the patient-specific plan includes determining, in real-time or in near real-time, a risk score for the patient using a machine learning model, in view of Saget, in order to allow the surgeon to predict problems and provide guidance in real-time situations.
Claim(s) 104 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frey (US 20180271602) and Mosnier (US 20200315708), as applied to claim 101 above, in view of Scholl (US 20170135770).
As for claim 104, Frey does not teach the method including in response to the likelihood not meeting the acceptance threshold, providing one or more instructions to guide further bending of the rod before repeating the operations of bending, comparing, and evaluating.
Scholl, also drawn to a method for treating a patient (see abstract), teaches the step of in response to the rod not complying with the patient-specific plan, providing one or more instructions to guide further bending of the rod before repeating the operations of manually bending and comparing (see para. 128) in order to provide the surgeon with the ability to appropriately plan, perform and assess surgical correction during a spinal procedure, as is known in this field of endeavor (see abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Frey with the method further comprising: in response to the rod not complying with the patient-specific plan, providing one or more instructions to guide further bending of the rod before repeating the operations of manually bending and comparing, in view of Scholl, in order to provide the surgeon with the ability to appropriately plan, perform and assess surgical correction during a spinal procedure, as is known in this field of endeavor.
Claim(s) 106 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frey (US 20180271602) and Mosnier (US 20200315708), as applied to claim 101 above, in view of Saget (US 20190122330).
As for claim 106, Frey does not appear to teach wherein comparing the rod to the patient-specific plan includes determining, in real-time or in near real-time, a risk score for the patient using a machine learning model.
Saget, also drawn to a method for treating a patient (see abstract), teaches wherein comparing the rod to the patient-specific plan includes determining, in real-time or in near real-time, a risk score for the patient using a machine learning model (see para. 4, 75) in order to allow the surgeon to predict problems and provide guidance in real-time situations (see para. 75).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Frey wherein comparing the rod to the patient-specific plan includes determining, in real-time or in near real-time, a risk score for the patient using a machine learning model, in view of Saget, in order to allow the surgeon to predict problems and provide guidance in real-time situations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 20110270262; US 20110265538; US 20180289396; US 20090261505; US 20090270922.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tara Carter whose telephone number is (571) 272-3402. The examiner can normally be reached on M-F 7am-3pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, 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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/TARA ROSE E CARTER/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773