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 .
Response to Arguments
In view of the amendments filed on 1/20/2026, the claim objection, cited in the office action of 10/17/2025, is moot.
Applicant's arguments filed 1/20/2026 have been fully considered but they are not persuasive. The Applicant contends that Lang does not disclose quadrants, preferred characteristics, geometric dimensions, measurements, and/or preferred dimensions of the medial anterior quadrant, medial posterior quadrant, lateral anterior quadrant, and lateral posterior quadrant. The examiner respectfully disagrees. Lang discloses imaging and modeling the entire joint of a patient and taking measurements of upper and lower articulating surfaces of the joint (paras. 0025-0029, 0078, 0108-0109). Modeling the entire joint will encompass the medial anterior and posterior portions of the joint and the lateral anterior and posterior portions of the joint. Lang further discloses using this information to construct an implant with preferred characteristics/geometries to fit a particular patient’s implantation site (paras. 0018, 0025-0026, 0194-0196). In view of these disclosures, it is maintained that Lang reads on the amended claim language, as described below.
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 1, 12, 20, and their dependent claims 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites “the one or more preferred characteristics of the implant comprise: a medial anterior preferred characteristic; a medial posterior preferred characteristic; a lateral anterior preferred characteristic; and a lateral posterior preferred characteristic.” It is unclear how more than one preferred characteristic can be determined if a single preferred characteristic comprises all of the medial anterior preferred characteristic, the medial posterior preferred characteristic, the lateral anterior preferred characteristic, and the lateral posterior preferred characteristic. Likewise, claim 12 recites the one or more preferred geometric dimensions of the implant comprise: a medial anterior geometric dimension; a medial posterior geometric dimension; a lateral anterior geometric dimension; and a lateral posterior geometric dimension. It is unclear how more than one preferred geometric dimensions can be determined if a single preferred geometric dimension comprises all of the medial anterior geometric dimension, the medial posterior geometric dimension, the lateral anterior geometric dimension, and the lateral posterior. In claim 20, it is unclear how more than one first radial measurement can be determined if a single first radial measurement comprises all of at the least one first radial measurement of the medial anterior quadrant; at least one first radial measurement of the medial posterior quadrant; at least one first radial measurement of the lateral anterior quadrant; and at least one first radial measurement of the lateral posterior quadrant. And it is unclear how more than one second radial measurement can be determined if a single second radial measurement comprises all of at the least one second radial measurement of the medial anterior quadrant; at least one second radial measurement of the medial posterior quadrant; at least one second radial measurement of the lateral anterior quadrant; and at least one second radial measurement of the lateral posterior quadrant. Appropriate correction and/or clarification is required.
Claim 20, lines 24-25, recites “calculating a ratio based on the first radial measurement and the second radial measurement.” It is unclear which first radial measurement and which second radial measurement this language is referring to. Appropriate correction and/or clarification is required.
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) 1-5 and 8-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lang et al. (WO 2004/032806 A1; hereinafter “Lang”).
As best interpreted, Lang discloses the following regarding claim 1: a method of performing an ankle arthroplasty procedure (paras. 0018, 0194-0196), the method comprising: collecting imaging data of an ankle of a patient (paras. 0018, 0038-0039, 0167, 0086-0088, 0090-0095); identifying a plurality of geometric regions on at least one surface of at least one bone of the ankle of the patient (paras. 0018, 0024, 0078-0082, 0086-0088, 0090-0095), wherein the plurality of geometric regions comprise four quadrants (paras. 0027-0029, 0078, 0108-0109), wherein the four quadrants comprise: a medial anterior quadrant; a medial posterior quadrant; a lateral anterior quadrant; and a lateral posterior quadrant (paras. 0027-0029, 0078, 0108-0109, as the procedure describes modeling the entire joint structure, it will encompass the claimed four quadrants); collecting at least one measurement of the at least one bone of the ankle of the patient (paras. 0078-0082, 0086-0088, 0090-0095, 0132-0134); performing one or more calculations based on the at least one measurement (paras. 0078-0082, 0086-0088, 0090-0095, 0132-0134); determining, based on the one or more calculations, one or more preferred characteristics of an implant for the patient (paras. 0078-0082, 0086-0088, 0090-0095, 0132-0134, 0194-0196), wherein the one or more preferred characteristics of the implant comprise: a medial anterior preferred characteristic; a medial posterior preferred characteristic; a lateral anterior preferred characteristic; and a lateral posterior preferred characteristic; selecting at least a portion of the implant based on the preferred characteristics (paras. 0018, 0025-0026, 0194-0196); and placing the implant within a joint space of the patient (paras. 0018, 0025-0026, 0194-0196).
Lang discloses the following regarding claim 2: the method of claim 1, wherein the imaging data comprises at least one of CT data or MRI data (para. 0075).
Lang discloses the following regarding claim 3: the method of claim 1, further comprising creating a virtual model of at least a portion of the ankle of the patient based on the imaging data (paras. 0018, 0078-0081).
Lang discloses the following regarding claim 4: the method of claim 1, wherein the at least one surface comprises at least one articulating surface of at least one bone of the ankle of the patient (paras. 0018, 0194-0196).
Lang discloses the following regarding claim 5: the method of claim 4, wherein the articulating surface comprises at least one of a superior surface of a talus or an inferior surface of the tibia of the patient (paras. 0018, 0194-0196).
Lang discloses the following regarding claim 8: the method of claim 5, wherein the at least one measurement comprises one or more radial measurements of the talus (paras. 0194-0196).
Lang discloses the following regarding claim 9: the method of claim 8, wherein the radial measurements of the at least one of the superior surface of the talus or the inferior surface of the tibia are measured substantially in the sagittal plane (paras. 0086-0088, 0090-0095, 0135, 0194-0196).
Lang discloses the following regarding claim 10: the method of claim 9, wherein the calculations comprise ratios calculated from the radial measurements of the at least one of the superior surface of the talus or the inferior surface of the tibia (paras. 0078-0082, 0086-0088, 0090-0095, 0135, 0194-0196).
Lang discloses the following regarding claim 11: the method of claim 1, wherein the preferred characteristics comprise geometric dimensions of the at least a portion of the implant (paras. 0078-0082, 0086-0088, 0090-0095, 0135, 0194-0196).
As best interpreted, Lang discloses the following regarding claim 12: a method of performing an ankle arthroplasty procedure (paras. 0018, 0194-0196), the method comprising: collecting imaging data of an ankle of a patient (paras. 0018, 0038-0039, 0167, 0086-0088, 0090-0095); identifying a plurality of geometric regions on at least one articulating surface of a talus or tibia of the patient (paras. 0018, 0024, 0078-0082, 0086-0088, 0090-0095, 0194-0196); collecting at least one radial measurement from the at least one articulating surface of the talus or tibia (paras. 0078-0082, 0086-0088, 0090-0095, 0194-0196); calculating at least one ratio based on the at least one radial measurement (paras. 0078-0082, 0086-0088, 0090-0095, 0135, 0194-0196); determining, based on the at least one ratio, one or more preferred geometric dimensions of an implant (paras. 0078-0082, 0086-0088, 0090-0095, 0132-0134, 0194-0196), wherein the one or more preferred geometric dimensions of the implant comprise: a medial anterior geometric dimension; a medial posterior geometric dimension; a lateral anterior geometric dimension; and a lateral posterior geometric dimension (paras. 0027-0029, 0078, 0108-0109, as the procedure describes modeling the entire joint structure, it will encompass the claimed geometric dimensions); selecting at least a portion of the implant based on the preferred geometric dimensions (paras. 0018, 0025-0026, 0194-0196); and placing the implant within a joint space of the patient (paras. 0018, 0025-0026, 0194-0196).
Lang discloses the following regarding claim 13: the method of claim 12, wherein the at least one radial measurement comprises at least one radial measurement of the talus (paras. 0194-0196).
Lang discloses the following regarding claim 14: the method of claim 12, wherein the at least one radial measurement comprises at least one radial measurement of the tibia (paras. 0194-0196).
Lang discloses the following regarding claim 15: the method of claim 12, further comprising defining four quadrants on at least one articulating surface of the tibia or talus (paras. 0018, 0024, 0078-0082, 0086-0088, 0090-0095, 0194-0196).
Lang discloses the following regarding claim 16: the method of claim 12, wherein the at least one ratio corresponds to at least one geometric dimension of at least a portion of the implant (paras. 0078-0082, 0086-0088, 0090-0095, 0135, 0194-0196).
Lang discloses the following regarding claim 17: the method of claim 12, wherein the preferred characteristics comprise geometric dimensions of the at least a portion of the implant (paras. 0078-0082, 0086-0088, 0090-0095, 0135, 0194-0196).
Lang discloses the following regarding claim 18: the method of claim 12, wherein the at least one ratio is calculated based on a first radial measurement of the articulating surface of the talus and a second radial measurement of the articulating surface of the tibia (paras. 0078-0082, 0086-0088, 0090-0095, 0135, 0194-0196).
Lang discloses the following regarding claim 19: the method of claim 12, wherein the at least one ratio corresponds to at least one of the plurality of geometric regions on the at least one articulating surface of the talus or tibia (paras. 0031-0032, 0078-0082, 0086-0088, 0090-0095, 0132-0135, 0194-0196).
As best interpreted, Lang discloses the following regarding claim 20: a method of performing an ankle arthroplasty procedure (paras. 0194-0196), the method comprising: collecting CT data of an ankle of a patient (paras. 0018, 0038-0039, 0167, 0086-0088, 0090-0095); identifying four quadrants on a first articulating surface of a talus and a second articulating surface of a tibia of the patient (paras. 0018, 0024, 0078-0082, 0086-0088, 0090-0095, 0194-0196), wherein the four quadrants comprise: a medial anterior quadrant; a medial posterior quadrant; a lateral anterior quadrant; and a lateral posterior quadrant (paras. 0027-0029, 0078, 0108-0109, as the procedure describes modeling the entire joint structure, it will encompass the claimed four quadrants); collecting at least one radial measurement from the first articulating surface (upper surfaces) (paras. 0018, 0024, 0078-0082, 0086-0088, 0090-0095, 0194-0196); wherein the at least one first radial measurement comprises: at least one first radial measurement of the medial anterior quadrant; at least one first radial measurement of the medial posterior quadrant; at least one first radial measurement of the lateral anterior quadrant; and at least one first radial measurement of the lateral posterior quadrant (paras. 0018, 0024-0029, 0078-0082, 0086-0088, 0090-0095, 0108-0109, 0194-0196, as the entire joint including the upper surfaces are measured and modeled); collecting at least one second radial measurement from the second articulating surface (lower surfaces), wherein the at least one second radial measurement comprises: at least one second radial measurement of the medial anterior quadrant; at least one second radial measurement of the medial posterior quadrant; at least one second radial measurement of the lateral anterior quadrant; and at least one second radial measurement of the lateral posterior quadrant (paras. 0018, 0024-0029, 0078-0082, 0086-0088, 0090-0095, 0108-0109, 0194-0196, as the entire joint including the lower surfaces are measured and modeled); calculating a ratio based on the first radial measurement and the second radial measurement (paras. 0031-0032, 0078-0082, 0086-0088, 0090-0095, 0132-0135, 0194-0196); determining, based on the ratio, preferred dimensions of an ankle implant (paras. 0078-0082, 0086-0088, 0090-0095, 0135, 0194-0196), wherein the preferred dimensions of the ankle implant comprise: a medial anterior preferred dimension that corresponds to the at least one first radial measurement and the at least one second radial measurement of the medial anterior quadrant; a medial posterior preferred dimension that corresponds to the at least one first radial measurement and the at least one second radial measurement of the medial posterior quadrant; a lateral anterior preferred dimension that corresponds to the at least one first radial measurement and the at least one second radial measurement of the lateral anterior quadrant; and a lateral posterior preferred dimension that corresponds to the at least one first radial measurement and the at least one second radial measurement of the lateral posterior quadrant (paras. 0018, 0024-0029, 0078-0082, 0086-0088, 0090-0095, 0108-0109, 0194-0196); selecting the ankle implant based on the preferred dimensions (paras. 0018, 0025-0026, 0194-0196); and placing the ankle implant within a joint space of the patient (paras. 0018, 0025-0026, 0194-0196).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774