Detailed Action
This is the first office action on the merits for US application number 19/070,936.
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 .
Election/Restrictions
Applicant’s election of Invention II of a method in the reply filed on June 1, 2026 is acknowledged, which indicated that claims 14-30 read on the elected species. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “pin guide” of ¶32 and claims 26-30 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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) 14-19, 21-24, and 26-29 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Firmbach et al. (US 2023/0285032, hereinafter “Firmbach”).
As to claim 14, Firmbach discloses a method of surgically preparing a patient's femur during performance of an orthopaedic knee procedure (Figs. 1-13), the method comprising: resecting a distal end of the patient's femur so as to create a resected planar surface (S, Figs. 5 and 6, ¶49 discloses that “S” is a resected femur distal end), determining an amount of cartilage loss on a posterior femoral condyle of the patient's femur (¶s 25 and 63 disclose different degrees of wear of the posterior condyles), selecting a shim (400, 400’, 400”, 400’’’, Fig. 9, ¶s 63 and 64) having a thickness (Fig. 9, ¶s 63 and 64) that corresponds to the determined amount of cartilage loss on the posterior femoral condyle of the patient's femur from a plurality of shims of differing thicknesses (400, 400’, 400”, 400’’’, Fig. 9, ¶s 63 and 64), installing the selected shim onto a paddle (2051, 2052, Figs. 5 and 6, ¶62) positioned on a posterior end of a 4-in-1 femoral cutting block (100, Figs. 5 and 6, ¶s 49 and 62), and positioning the 4-in-1 femoral cutting block on the resected distal end of the patient's femur such that (i) a backside surface of the 4-in-1 femoral cutting block contacts the resected planar surface (Figs. 5 and 6, ¶s 11 and 53), and (ii) the shim installed on the paddle contacts the posterior femoral condyle of the patient's femur (Figs. 5 and 6, ¶s 11 and 25).
As to claim 15, Firmbach discloses pinning the 4-in-1 femoral cutting block to the patient's femur subsequent to positioning thereof on the resected distal end thereof (Figs. 5 and 6, ¶s 53 and 54), and performing further resections on the patient's femur by use of the pinned 4-in-1 femoral cutting block (¶s 49 and 54).
As to claim 16, Firmbach discloses that the performing further resections comprises performing an anterior resection (via 107, ¶s 49 and 54), a distal resection(via 108,¶s 49 and 54), and a pair of chamfer resections (via 109 and 110, ¶s 49 and 54)on the patient's femur by use of the pinned 4-in-1 femoral cutting block (¶s 49 and 54).
As to claim 17, Firmbach discloses that the determining the amount of cartilage loss comprises determining an amount of cartilage loss on a medial posterior femoral condyle of the patient's femur (¶s 25, 62, and 63, where ¶25 discloses medial shims for contacting the medial posterior condyle, ¶62 discloses medial paddle 2052 for contact with the medial posterior condyle KM), selecting the shim comprises selecting a shim (400, 400’, 400”, 400’’’, Fig. 9, ¶s 63 and 64) having a thickness (Fig. 9, ¶s 63 and 64) that corresponds to the determined amount of cartilage loss on the medial posterior femoral condyle of the patient's femur from a plurality of shims of differing thicknesses (400, 400’, 400”, 400’’’, Fig. 9, ¶s 63 and 64), installing the selected shim comprises installing the selected shim onto a medial paddle (2052, Figs. 5 and 6, ¶62) positioned on the posterior end of the 4-in-1 femoral cutting block (Figs. 5 and 6, ¶62), and positioning the 4-in-1 femoral cutting block comprises positioning the 4-in-1 femoral cutting block on the resected distal end of the patient's femur such that (i) the backside surface of the 4-in-1 femoral cutting block contacts the resected planar surface (Figs. 5 and 6, ¶s 11 and 53), and (ii) the shim installed on the medial paddle contacts the medial posterior femoral condyle of the patient's femur (Figs. 5 and 6, ¶s 11, 25, 62, and 63).
As to claim 18, Firmbach discloses that the determining the amount of cartilage loss comprises determining an amount of cartilage loss on a lateral posterior femoral condyle of the patient's femur (¶s 25, 62, and 63, where ¶25 discloses lateral shims for contacting the lateral posterior condyle, ¶62 discloses lateral paddle 2051 for contact with the lateral posterior condyle KL), selecting the shim comprises selecting a shim (400, 400’, 400”, 400’’’, Fig. 9, ¶s 63 and 64) having a thickness (Fig. 9, ¶s 63 and 64) that corresponds to the determined amount of cartilage loss on the lateral posterior femoral condyle of the patient's femur from a plurality of shims of differing thicknesses (400, 400’, 400”, 400’’’, Fig. 9, ¶s 63 and 64), installing the selected shim comprises installing the selected shim onto a lateral paddle (2051, Figs. 5 and 6, ¶62) positioned on the posterior end of the 4-in-1 femoral cutting block (Figs. 5 and 6, ¶62), and positioning the 4-in-1 femoral cutting block comprises positioning the 4-in-1 femoral cutting block on the resected distal end of the patient's femur such that (i) the backside surface of the 4-in-1 femoral cutting block contacts the resected planar surface (Figs. 5 and 6, ¶s 11 and 53), and (ii) the shim installed on the lateral paddle contacts the lateral posterior femoral condyle of the patient's femur (Figs. 5 and 6, ¶s 11, 25, 62, and 63).
As to claim 19, Firmbach discloses that the determining the amount of cartilage loss comprises determining an amount of cartilage loss on both a medial posterior femoral condyle of the patient's femur (¶s 25, 62, and 63, where ¶25 discloses medial shims for contacting the medial posterior condyle, ¶62 discloses lateral paddle 2052 for contact with the medial posterior condyle KM) and a lateral posterior femoral condyle of the patient's femur (¶s 25, 62, and 63, where ¶25 discloses lateral shims for contacting the lateral posterior condyle, ¶62 discloses lateral paddle 2051 for contact with the lateral posterior condyle KL), selecting the shim comprises (i) selecting a medial shim (400, 400’, 400”, 400’’’, Fig. 9, ¶s 63 and 64) having a thickness (Fig. 9, ¶s 63 and 64) that corresponds to the determined amount of cartilage loss on the medial posterior femoral condyle of the patient's femur from a plurality of shims of differing thicknesses (400, 400’, 400”, 400’’’, Fig. 9, ¶s 63 and 64), and (ii) selecting a lateral shim (400, 400’, 400”, 400’’’, Fig. 9, ¶s 63 and 64) having a thickness (Fig. 9, ¶s 63 and 64) that corresponds to the determined amount of cartilage loss on the lateral posterior femoral condyle of the patient's femur from the plurality of shims of differing thicknesses (400, 400’, 400”, 400’’’, Fig. 9, ¶s 63 and 64), installing the selected shim comprises (i) installing the selected medial shim onto a medial paddle (2052, Figs. 5 and 6, ¶62) positioned on a posterior end of a 4-in-1 femoral cutting block (Figs. 5 and 6, ¶62), and (ii) installing the selected lateral shim onto a lateral paddle (2051, Figs. 5 and 6, ¶62) positioned on the posterior end of the 4-in-1 femoral cutting block (Figs. 5 and 6, ¶62), and positioning the 4-in-1 femoral cutting block comprises positioning the 4-in-1 femoral cutting block on the resected distal end of the patient's femur such that (i) the backside surface of the 4-in-1 femoral cutting block contacts the resected planar surface (Figs. 5 and 6, ¶s 11 and 53), (ii) the medial shim installed on the medial paddle contacts the medial posterior femoral condyle of the patient's femur (Figs. 5 and 6, ¶s 11, 25, 62, and 63), and (iii) the lateral shim installed on the lateral paddle contacts the lateral posterior femoral condyle of the patient's femur (Figs. 5 and 6, ¶s 11, 25, 62, and 63).
As to claim 21, Firmbach discloses a method of surgically preparing a patient's femur during performance of an orthopaedic knee procedure (Figs. 1-13), the method comprising: determining an amount of cartilage loss on a posterior femoral condyle of the patient's femur (¶s 25 and 63 disclose different degrees of wear of the posterior condyles), selecting a shim (400, 400’, 400”, 400’’’, Fig. 9, ¶s 63 and 64) having a thickness (Fig. 9, ¶s 63 and 64) that corresponds to the determined amount of cartilage loss on the posterior femoral condyle of the patient's femur from a plurality of shims of differing thicknesses (400, 400’, 400”, 400’’’, Fig. 9, ¶s 63 and 64), installing the selected shim onto a paddle (2051, 2052, Figs. 5 and 6, ¶62) positioned on a posterior end of a femoral cutting block (100, Figs. 5 and 6, ¶s 49 and 62), and positioning the femoral cutting block on a distal end of the patient's femur such that (i) a backside surface of the femoral cutting block contacts the distal end of the patient's femur (Figs. 5 and 6, ¶s 11 and 53), and (ii) the shim installed on the paddle contacts the posterior femoral condyle of the patient's femur (Figs. 5 and 6, ¶s 11 and 25).
As to claim 22, Firmbach discloses pinning the femoral cutting block to the patient's femur subsequent to positioning thereof on the distal end thereof (Figs. 5 and 6, ¶s 53 and 54), and performing resections on the patient's femur by use of the pinned femoral cutting block (¶s 49 and 54).
As to claim 23, Firmbach discloses that the determining the amount of cartilage loss comprises determining an amount of cartilage loss on a medial posterior femoral condyle of the patient's femur (¶s 25, 62, and 63, where ¶25 discloses medial shims for contacting the medial posterior condyle, ¶62 discloses medial paddle 2052 for contact with the medial posterior condyle KM), selecting the shim comprises selecting a shim (400, 400’, 400”, 400’’’, Fig. 9, ¶s 63 and 64) having a thickness (Fig. 9, ¶s 63 and 64) that corresponds to the determined amount of cartilage loss on the medial posterior femoral condyle of the patient's femur from a plurality of shims of differing thicknesses (400, 400’, 400”, 400’’’, Fig. 9, ¶s 63 and 64), installing the selected shim comprises installing the selected shim onto a medial paddle (2052, Figs. 5 and 6, ¶62) positioned on the posterior end of the femoral cutting block (Figs. 5 and 6, ¶62), and positioning the femoral cutting block comprises positioning the femoral cutting block on the distal end of the patient's femur such that (i) the backside surface of the femoral cutting block contacts the distal end of the patient's femur (Figs. 5 and 6, ¶s 11 and 53), and (ii) the shim installed on the medial paddle contacts the medial posterior femoral condyle of the patient's femur (Figs. 5 and 6, ¶s 11, 25, 62, and 63).
As to claim 24, Firmbach discloses that the determining the amount of cartilage loss comprises determining an amount of cartilage loss on a lateral posterior femoral condyle of the patient's femur (¶s 25, 62, and 63, where ¶25 discloses lateral shims for contacting the lateral posterior condyle, ¶62 discloses lateral paddle 2051 for contact with the lateral posterior condyle KL), selecting the shim comprises selecting a shim (400, 400’, 400”, 400’’’, Fig. 9, ¶s 63 and 64) having a thickness (Fig. 9, ¶s 63 and 64) that corresponds to the determined amount of cartilage loss on the lateral posterior femoral condyle of the patient's femur from a plurality of shims of differing thicknesses (400, 400’, 400”, 400’’’, Fig. 9, ¶s 63 and 64), installing the selected shim comprises installing the selected shim onto a lateral paddle (2051, Figs. 5 and 6, ¶62) positioned on the posterior end of the femoral cutting block (Figs. 5 and 6, ¶62), and positioning the femoral cutting block comprises positioning the femoral cutting block on the distal end of the patient's femur such that (i) the backside surface of the femoral cutting block contacts the distal end of the patient's femur (Figs. 5 and 6, ¶s 11 and 53), and (ii) the shim installed on the lateral paddle contacts the lateral posterior femoral condyle of the patient's femur (Figs. 5 and 6, ¶s 11, 25, 62, and 63).
As to claim 26, Firmbach discloses a method of surgically preparing a patient's femur during performance of an orthopaedic knee procedure (Figs. 1-13), the method comprising: determining an amount of cartilage loss on a posterior femoral condyle of the patient's femur (¶s 25 and 63 disclose different degrees of wear of the posterior condyles), selecting a shim (400, 400’, 400”, 400’’’, Fig. 9, ¶s 63 and 64) having a thickness (Fig. 9, ¶s 63 and 64) that corresponds to the determined amount of cartilage loss on the posterior femoral condyle of the patient's femur from a plurality of shims of differing thicknesses (400, 400’, 400”, 400’’’, Fig. 9, ¶s 63 and 64), installing the selected shim onto a paddle (2051, 2052, Figs. 5 and 6, ¶62) positioned on a posterior end of a femoral pin guide (100, Figs. 5 and 6, ¶s 49, 54, and 62; where 100 is capable of guiding a femoral pin via 111s as labeled on Fi. 7 in as much as Applicant’s shown guide), and positioning the femoral pin guide on a distal end of the patient's femur such that (i) a backside surface of the femoral pin guide contacts the distal end of the patient's femur (Figs. 5 and 6, ¶s 11 and 53), and (ii) the shim installed on the paddle contacts the posterior femoral condyle of the patient's femur (Figs. 5 and 6, ¶s 11 and 25).
As to claim 27, Firmbach discloses pinning the femoral pin guide to the patient's femur subsequent to positioning the femoral pin guide on the distal end thereof (Figs. 5 and 6, ¶s 53 and 54).
As to claim 28, Firmbach discloses that the determining the amount of cartilage loss comprises determining an amount of cartilage loss on a medial posterior femoral condyle of the patient's femur (¶s 25, 62, and 63, where ¶25 discloses medial shims for contacting the medial posterior condyle, ¶62 discloses medial paddle 2052 for contact with the medial posterior condyle KM), selecting the shim comprises selecting a shim (400, 400’, 400”, 400’’’, Fig. 9, ¶s 63 and 64) having a thickness (Fig. 9, ¶s 63 and 64) that corresponds to the determined amount of cartilage loss on the medial posterior femoral condyle of the patient's femur from a plurality of shims of differing thicknesses (400, 400’, 400”, 400’’’, Fig. 9, ¶s 63 and 64), installing the selected shim comprises installing the selected shim onto a medial paddle (2052, Figs. 5 and 6, ¶62) positioned on the posterior end of the femoral pin guide (Figs. 5 and 6, ¶62), and positioning the femoral pin guide comprises positioning the femoral pin guide on the distal end of the patient's femur such that (i) the backside surface of the femoral pin guide contacts the distal end of the patient's femur (Figs. 5 and 6, ¶s 11 and 53), and (ii) the shim installed on the medial paddle contacts the medial posterior femoral condyle of the patient's femur (Figs. 5 and 6, ¶s 11, 25, 62, and 63).
As to claim 29, Firmbach discloses that the determining the amount of cartilage loss comprises determining an amount of cartilage loss on a lateral posterior femoral condyle of the patient's femur (¶s 25, 62, and 63, where ¶25 discloses lateral shims for contacting the lateral posterior condyle, ¶62 discloses lateral paddle 2051 for contact with the lateral posterior condyle KL), selecting the shim comprises selecting a shim (400, 400’, 400”, 400’’’, Fig. 9, ¶s 63 and 64) having a thickness (Fig. 9, ¶s 63 and 64) that corresponds to the determined amount of cartilage loss on the lateral posterior femoral condyle of the patient's femur from a plurality of shims of differing thicknesses (400, 400’, 400”, 400’’’, Fig. 9, ¶s 63 and 64), installing the selected shim comprises installing the selected shim onto a lateral paddle (2051, Figs. 5 and 6, ¶62) positioned on the posterior end of the femoral pin guide (Figs. 5 and 6, ¶62), and positioning the femoral pin guide comprises positioning the femoral pin guide on the distal end of the patient's femur such that (i) the backside surface of the femoral pin guide contacts he distal end of the patient's femur (Figs. 5 and 6, ¶s 11 and 53), and (ii) the shim installed on the lateral paddle contacts the lateral posterior femoral condyle of the patient's femur (Figs. 5 and 6, ¶s 11, 25, 62, and 63).
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 of this title, 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) 20, 25, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Firmbach in view of Steensen et al. (US 2019/0231365, hereinafter “Steensen”).
As to claim 20, Firmbach discloses the invention of claim 14.
Firmbach is silent to determining the amount of cartilage loss on the posterior femoral condyle of the patient's femur comprises advancing a depth probe into cartilage of the posterior femoral condyle of the patient's femur.
Steensen teaches a similar method of surgically preparing a patient's femur during performance of an orthopaedic knee procedure (Figs. 11A-12F and 14A-14C, ¶107 discloses distal femoral resection), the method comprising: resecting a distal end of the patient's femur so as to create a resected surface (abstract, ¶s 107-109), determining an amount of cartilage loss on a condyle of the patient's bone (¶s 20 and 107), wherein the determining the amount of cartilage loss on the posterior femoral condyle of the patient's femur comprises advancing a depth probe (550, Figs. 14A-14C, ¶s 92 and 96) into cartilage of the posterior femoral condyle of the patient's femur (¶s 92, 96, and ¶107).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the method of determining the amount of cartilage loss as disclosed by Firmbach to comprise advancing a depth probe into cartilage of the posterior femoral condyle of the patient's femur as taught by Steensen in order to enable the surgeon to read reference marking to determine the thickness of the cartilage at the beginning of the procedure (Steensen ¶s 92 and 96) to quantify the amount of wear of the area (Steensen ¶107) to adjust a cutting block to compensate for the wear on each condyle (Firmbach ¶25; Steensen ¶107).
As to claim 25, Firmbach discloses the invention of claim 21.
Firmbach is silent to determining the amount of cartilage loss on the posterior femoral condyle of the patient's femur comprises advancing a depth probe into cartilage of the posterior femoral condyle of the patient's femur.
Steensen teaches a similar method of surgically preparing a patient's femur during performance of an orthopaedic knee procedure (Figs. 11A-12F and 14A-14C, ¶107 discloses distal femoral resection), the method comprising: resecting a distal end of the patient's femur so as to create a resected surface (abstract, ¶s 107-109), determining an amount of cartilage loss on a condyle of the patient's bone (¶s 20 and 107), wherein the determining the amount of cartilage loss on the posterior femoral condyle of the patient's femur comprises advancing a depth probe (550, Figs. 14A-14C, ¶s 92 and 96) into cartilage of the posterior femoral condyle of the patient's femur (¶s 92, 96, and ¶107).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the method of determining the amount of cartilage loss as disclosed by Firmbach to comprise advancing a depth probe into cartilage of the posterior femoral condyle of the patient's femur as taught by Steensen in order to enable the surgeon to read reference marking to determine the thickness of the cartilage at the beginning of the procedure (Steensen ¶s 92 and 96) to quantify the amount of wear of the area (Steensen ¶107) to adjust a cutting block to compensate for the wear on each condyle (Firmbach ¶25; Steensen ¶107).
As to claim 30, Firmbach discloses the invention of claim 26.
Firmbach is silent to determining the amount of cartilage loss on the posterior femoral condyle of the patient's femur comprises advancing a depth probe into cartilage of the posterior femoral condyle of the patient's femur.
Steensen teaches a similar method of surgically preparing a patient's femur during performance of an orthopaedic knee procedure (Figs. 11A-12F and 14A-14C, ¶107 discloses distal femoral resection), the method comprising: resecting a distal end of the patient's femur so as to create a resected surface (abstract, ¶s 107-109), determining an amount of cartilage loss on a condyle of the patient's bone (¶s 20 and 107), wherein the determining the amount of cartilage loss on the posterior femoral condyle of the patient's femur comprises advancing a depth probe (550, Figs. 14A-14C, ¶s 92 and 96) into cartilage of the posterior femoral condyle of the patient's femur (¶s 92, 96, and ¶107).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the method of determining the amount of cartilage loss as disclosed by Firmbach to comprise advancing a depth probe into cartilage of the posterior femoral condyle of the patient's femur as taught by Steensen in order to enable the surgeon to read reference marking to determine the thickness of the cartilage at the beginning of the procedure (Steensen ¶s 92 and 96) to quantify the amount of wear of the area (Steensen ¶107) to adjust a cutting block to compensate for the wear on each condyle (Firmbach ¶25; Steensen ¶107).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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/AMY R SIPP/ Primary Examiner, Art Unit 3775
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