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 .
DETAILED ACTION
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3: "a first femoral plate from a plurality of tibial plates" should read "a first femoral plate from a plurality of femoral plates".
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 3, 7, 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 pre-AIA the applicant regards as the invention.
Claim 3 recites the limitation "each femoral plate". There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites “a proximal end of a patient’s tibia” and “a distal end of a patient’s femur”. It is unclear if these elements are the same as those defined in claim 1, from which claim 7 depends.
Claim 8 recites “a proximal end of a patient’s tibia”. It is unclear if this element is the same as the element defined in claim 7 and/or in claim 1, both of which claim 8 depends on.
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)(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 1 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tetsuya et al. (WO 2012020460) .
Regarding claim 1, Tetsuya et al. disclose a method of operating an orthopaedic instrument [0022], comprising: selecting a tibial plate including a medial pad and a lateral pad configured to engage a proximal end of a patient’s tibia [0028] figs. 2, 3, 26 (3, 13, 15, 21), coupling the selected tibial plate to a superior end of a first instrument component fig. 6 (23a, 23b), selecting a femoral plate including a medial pad and a lateral pad configured to engage a distal end of a patient’s femur figs. 9 and 12 (5) (see fig. below), coupling the selected femoral plate to a superior end of a second instrument component fig. 2 (7) such that the selected femoral plate is operable to pivot relative to the second instrument component [0025], coupling the second instrument to the first instrument component such that an inferior-superior distance is defined between the selected femoral plate and the selected tibial plate [0030] fig. 4 (31), coupling a pair of distractor arms fig. 16 (71a, 73a) of a third instrument component to the first instrument component and the second instrument component [0050], and moving a second distractor arm fig. 16 (73a) of the pair of distractor arms relative to a first distractor arm to move the selected femoral plate relative to the selected tibial plate and change the inferior-superior distance [0061, 0064].
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Claims 1-3, 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Plaskos et al. (US 2019/0008501 A1).
Regarding claim 1, Plaskos et al. disclose a method of operating an orthopaedic instrument, comprising: selecting a tibial plate fig. 2d (12) including a medial pad and a lateral pad (see fig. below) configured to engage a proximal end of a patient’s tibia [0103, 0104], coupling [0102] the selected tibial plate to a superior end of a first instrument component fig. 2d (9)[0102], selecting a femoral plate [0095] including a medial pad fig. 2d (22) and a lateral pad fig. 2d (24) configured to engage a distal end of a patient’s femur, coupling the selected femoral plate fig. 2d (22, 24) to a superior end of a second instrument component fig. 2b (17) [0097] such that the selected femoral plate is operable to pivot relative to the second instrument component [0092], coupling the second instrument component to the first instrument component such that an inferior-superior distance is defined between the selected femoral plate and the selected tibial plate [0100, 0107], coupling a pair of distractor arms fig. 2c (21, 23) of a third instrument component fig. 2d to the first instrument component and the second instrument component, and moving a second distractor arm of the pair of distractor arms relative to a first distractor arm to move the selected femoral plate relative to the selected tibial plate and change the inferior-superior distance fig. 9c [0146].
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Regarding claim 2, Plaskos et al. disclose the method of claim 1, wherein selecting the tibial plate includes selecting a first tibial plate from a plurality of tibial plates [0025, 0103], each of the plurality of tibial plates having a different size [0025, 0098, 0103].
Regarding claim 3, Plaskos et al. disclose the method of claim 1, wherein selecting the femoral plate includes selecting a first femoral plate from a plurality of femoral plates [0100, 0101], each of the plurality of femoral plates having a different size [0100].
Regarding claim 5, Plaskos et al. disclose the method of claim 1, wherein coupling the selected femoral plate to the superior end of the second instrument component includes: aligning an elongated pin fig. 2a (45) of the selected femoral plate with a bore, defined in the second instrument component fig. 2d (30, 31) [0112], the elongated pin being positioned anterior of the medial pad and the lateral pad of the selected femoral plate, and advancing the elongated pin into the bore [0112].
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.
Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Tetsuya et al. (WO2012020460) in view of Sherman et al. (US 20130261505 A1).
Regarding claim 2, Tetsuya et al. disclose the method of claim 1.
However, Tetsuya et al. do not disclose wherein selecting the tibial plate includes selecting a first tibial plate from a plurality of tibial plates, each tibial plate of the plurality of tibial plates having a different size.
Regarding claim 2, Sherman et al. disclose wherein selecting the tibial plate fig. 2 (34), includes selecting a first tibial plate from a plurality of tibial plates, each tibial plate of the plurality of tibial plates having a different size [0064].
It would have been obvious to one of ordinary skill in the art at the time of filing to combine the teachings of Tetsuya et al. with those of Sherman et al. to allow a surgeon to select an appropriately sized tibial plate for patient’s anatomy for the knee balancing instrument.
Regarding claim 3, Tetsuya et al. and Sherman et al. disclose the method of claim 1, wherein selecting the femoral plate includes selecting a first femoral plate from a plurality of tibial plates, each femoral plate of the plurality of femoral plates having a different size [0064 of Sherman et al.].
Regarding claim 4, Tetsuya et al. and Sherman et al. disclose the method of claim 1, wherein coupling the selected tibial plate to the superior end of the first instrument component includes: aligning a slot positioned between the medial pad and the lateral pad of the selected tibial plate with a posterior end of a support arm of the first instrument component [0057 of Tetsuya et al.] fig. 2 (33) of Tetsuya et al., positioning the posterior end of the support arm in the slot of the selected tibial plate [0032 of Tetsuya et al.] fig. 16 (73) of Tetsuya et al., and operating a moveable flange fig. 19 (89) of Tetsuya et al. to engage the posterior end of the support arm to secure the selected tibial plate to the first instrument component [0032 of Tetsuya et al.] fig. 6 (33) of Tetsuya et al.
Regarding claim 5, Tetsuya et al. and Sherman et al. disclose the method of claim 1, wherein coupling the selected femoral plate to the superior end of the second instrument component includes: aligning an elongated pin (47) of the selected femoral plate with a bore defined in the second instrument component figs. 12 and 14 (7, 57) of Tetsuya et al. [0067 of Tetsuya et al.], the elongated pin being positioned anterior of the medial pad and the lateral pad of the selected femoral plate (see fig. below), and advancing the elongated pin into the bore [0040 of Tetsuya et al.].
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Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Tetsuya et al. (WO2012020460) and Sherman et al. (US 20130261505 A1), as applied to claim 5 above, further in view of Supper et al. (US 20060155295 A1).
Regarding claim 6, Tetsuya et al. and Sherman et al. disclose the method of claim 5.
However, Tetsuya et al. and Sherman et al. do not disclose wherein coupling the selected femoral plate to the superior end of the second instrument component further includes: aligning a key of the selected femoral plate with a keyway defined in the second instrument component, the key being positioned adjacent to the elongated pin, advancing the key into a posterior opening of the keyway, and rotating the selected femoral plate to advance the key along a section of the keyway extending into a medial-lateral direction.
Regarding claim 6, Supper et al. disclose wherein coupling the selected femoral plate to the superior end of the second instrument component further includes: aligning a key of the selected femoral plate fig. 1 (30) with a keyway fig. 1 (31) defined in the second instrument component, the key being positioned adjacent to the elongated pin, advancing the key into a posterior opening of the keyway [0023], and rotating the selected femoral plate to advance the key along a section of the keyway extending into a medial-lateral direction [0031].
It would have been obvious to one of ordinary skill in the art at the time of filing to combine the teachings of Tetsuya et al. and Sherman et al. with those of Supper et al. as the key and keyway connection as taught by Supper et al. is an alternative handle/ actuation mechanism that can be used to insert and position the knee balancer instrument.
Regarding claim 7, Tetsuya et al., Sherman et al., and Supper et al. disclose the method of claim 1, further comprising: inserting the selected femoral plate and the selected tibial plate between a proximal end of a patient’s tibia and a distal end of a patient’s femur [0025 of Tetsuya et al.], and using a visual gauge of the third instrument component to determine a ligament tension while moving the first distractor arm of the pair if distractor arms relative to the second distractor arm [0020 of Supper et al.] fig. 1 (24, 25) of Supper et al. and moving the selected femoral plate relative to the selected tibial plate [0029 of Supper et al.].
Regarding claim 8, Tetsuya et al., Sherman et al., and Supper et al. disclose the method of claim 7, wherein inserting the selected femoral plate and the selected tibial plate between the proximal end of the patient’s tibia and the distal end of the patient’s femur includes inserting the selected femoral plate and the selected tibial plate between a proximal end of a patient’s tibia and an unresected distal end of the patient’s femur [0012 of Tetsuya et al.].
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Tetsuya et al. (WO2012020460), Sherman et al. (US 20130261505 A1), and Supper et al. (US 20060155295 A1), as applied to claim 7 above, further in view of Booth, Jr. et al. (US 5,540,696 A).
Regarding claim 9, Tetsuya et al., Sherman et al., and Supper et al. disclose the method of claim 7.
However, Tetsuya et al., Sherman et al., and Supper et al. do not disclose wherein inserting the selected femoral plate and the selected tibial plate between the proximal end of the patient’s tibia and the distal end of the patient’s femur includes inserting the selected femoral plate and the selected tibial plate between a resected proximal surface of the patient’s tibia and a resected distal end of the patient’s femur.
Regarding claim 9, Booth, Jr. et al. disclose wherein inserting the selected femoral plate and the selected tibial plate between the proximal end of the patient’s tibia and the distal end of the patient’s femur includes inserting the selected femoral plate and the selected tibial plate between a resected proximal surface of the patient’s tibia and a resected distal end of the patient’s femur fig. 3 [col. 3, lines 44-49].
It would have been obvious to one of ordinary skill in the art at the time of filing to combine the teachings of Tetsuya et al., Sherman et al., and Supper et al. with those of Booth, Jr. et al. as the devices as taught by Tetsuya et al., Sherman et al., and Supper et al., are used in knee replacement surgery, which is detailed by Booth, Jr et al. and could be used in the same way/ similarly as the device as taught by Booth, Jr. et al. and achieve the same outcome.
Regarding claim 10, Tetsuya et al., Sherman et al., Supper et al., and Booth, Jr. et al. disclose the method of claim 7, further comprising: coupling a fourth instrument component to the second instrument component figs. 9-10A (100, 110) of Booth, Jr. et al., and advancing a stylus of the fourth instrument component into engagement with an anterior surface of the patient’s femur figs. 5 and 6 (104) of Booth, Jr. et al.
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Plaskos et al. (US 2019/0008501 A1) in view of Supper et al. (US 2006/0155295 A1).
Regarding claim 6, Plaskos et al. disclose the method of claim 5.
However, Plaskos et al. do not disclose coupling the selected femoral plate to the superior end of the second instrument component further includes: aligning a key of the selected femoral plate with a keyway defined in the second instrument component, the key being positioned adjacent to the elongated pin, advancing the key into a posterior opening of the keyway, and rotating the selected femoral plate to advance the key along a section of the keyway extending in a medial-lateral direction.
Regarding claim 6, Supper et al. disclose coupling the selected femoral plate to the superior end of the second instrument component further includes: aligning a key fig. 1 (30) of the selected femoral plate with a keyway fig. 1 (31) defined in the second instrument component, the key being positioned adjacent to the elongated pin, advancing the key into a posterior opening of the keyway [0023], and rotating the selected femoral plate to advance the key along a section of the keyway extending in a medial-lateral direction [0031].
It would have been obvious to one of ordinary skill in the art at the time of filing to combine the teachings of Plaskos et al. with those of Supper et al. as both teach devices for distracting a knee joint during orthopedic surgery, allowing for resection, implant trialing, and realignment correction of a patient’s knee. The method of actuating taught by Supper et al. is similar to the method taught by Plaskos et al., through use of a bellow assembly. Both methods allow for the linear motion of a device tibial and femur plates.
Regarding claim 7, Plaskos et al. and Supper et al. disclose the method of claim 1, further comprising: inserting the selected femoral plate and the selected tibial plate between the proximal end of the patient’s tibia and the distal end of the patient’s femur fig. 6a of Plaskos et al., and using a visual gauge fig. 2h (130) of Plaskos et al. of the third instrument component to determine a ligament tension while moving the first distractor arm of the pair of distractor arms relative to the second distractor arm [0134 of Plaskos et al.] and moving the selected femoral plate relative to the selected tibial plate.
Regarding claim 8, Plaskos et al. and Supper et al. disclose the method of claim 7, wherein inserting the selected femoral plate and the selected tibial plate between the proximal end of the patient’s tibia and the distal end of the patient’s femur includes inserting the selected femoral plate and the selected tibial plate between the proximal end of the patient’s tibia and an unresected distal end of the patient’s femur [0109 of Plaskos et al.].
Regarding claim 9, Plaskos et al. and Supper et al. disclose the method of claim 7, wherein inserting the selected femoral plate and the selected tibial plate between the proximal end of the patient’s tibia and the distal end of the patient’s femur includes inserting the selected femoral plate and the selected tibial plate between a resected proximal surface of the patient’s tibia and a resected distal end of the patient’s femur fig. 13a (416) of Plaskos et al.
Claims 10 is rejected under 35 U.S.C. 103 as being unpatentable over Plaskos et al. (US 2019/0008501 A1) in view of Supper et al. (US 2006/0155295 A1) as applied to claim 7, further in view of Booth, Jr. et al. (US 5,540,696 A).
Regarding claim 10, Plaskos et al. and Supper et al. disclose the method of claim 7.
However, Plaskos et al. and Supper et al. do not disclose coupling a fourth instrument component to the second instrument component, and advancing a stylus of the fourth instrument component into engagement with an anterior surface of the patient’s femur.
Regarding claim 10, Booth, Jr. et al. disclose coupling a fourth instrument component to the second instrument component figs. 9 and 10a (100, 110), and advancing a stylus of the fourth instrument component into engagement with an anterior surface of the patient’s femur figs. 5 and 6 (104).
It would have been obvious to one of ordinary skill in the art at the time of filing to combine the teachings of Plaskos et al. and Supper et al. with those of Booth, Jr. et al. as all 3 disclose a device for distracting a knee joint. The arm taught by Booth, Jr. et al. is designed to provide visual alignment of the device, allowing for the surgeon to quickly reference the location of the device. This arm is an alternative to the various “optical tracking systems” disclosed by Plaskos et al., which, like the arm of Booth, Jr. et al., is intended to be a non-invasive tracking system during surgery.
Claim 4 is rejected under under 35 U.S.C. 103 as being unpatentable over Plaskos et al. (US 2019/0008501 A1).
Regarding claim 4, Plaskos et al. disclose the method of claim 1, wherein coupling the selected tibial plate to the superior end of the first instrument component includes: aligning a slot fig. 3b (15) [0113]… positioning the posterior end of the support arm [0113, quick release of 10 from slot rails 15 using button 14] and in the slot of the selected tibial plate, and operating a movable flange to engage the posterior end of the support arm to secure the selected tibial plate to the first instrument component figs. 3a-3d (14, 15) [0113].
However, Plaskos et al. do not exclusively disclose the slot being positioned between the medial pad and the lateral pad of the selected tibial plate with a posterior end of a support arm of the first instrument component. It would be obvious to one of ordinary skill in the art at the time of filing that these features could alternatively exist closer to the center of the body 9 rather than one either side as depicted by Plaskos et al., depending on the mechanism for connecting/disconnecting components of the device. Plaskos et al. happens to teach these on either side of the body 9 to fit the use of two actuating bellows 17. Conclusion
This is a child of applicant's earlier Application No. 16369451. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMEH RAAFAT BOLES whose telephone number is (571)270-5537. The examiner can normally be reached 9-5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached 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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/SAMEH R BOLES/Primary Examiner, Art Unit 3775
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