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 Amendment
Claims 1-19 are pending in the application. Claims 1-5, 11, 12, and 15-19 are withdrawn. Claims 6-10, 13, and 14 are rejected.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 6-10, 13 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lieberman et al (US PG Pub 2014/0081411).
Regarding claim 6, Lieberman teaches an orthopaedic system (see, for example, Fig. 1) comprising:
a plurality of femoral cone1 augments (24, 24A, 24B, and 24C or 224, 224A, and 224B) (See Figs 3-10, and 15-18; paragraphs [0075] and [0099]) configured2 to be implanted into a surgically-prepared cavity in a distal end of a femur of a patient, wherein each of the plurality of femoral cone augments has (i) a medial/lateral augment taper angle that is the same as each of the other of the plurality of femoral cone augments, (See paragraphs [0083] and [0105]-[0108]; note Lieberman teaches the sleeves are “essentially identical over the axial length” and “differ only in the size of the bases” paragraph [0083]) and (ii) a medial/lateral augment width (dimension of the bases 262, 262A, and 262B) that is different from each of the other of the plurality of femoral cone augments (See paragraphs [0083] and [0109]-[0110]), and
a plurality of femoral surgical broaches (302, 302A, and 302B) having cutting teeth (312, 312A, and 312B) (See Figs. 21-25; paragraphs [0110]-[0112]) configured3 to cut bone to form the surgically-prepared cavity in the distal end of the femur of the patient (See paragraph [0115]), wherein each of the plurality of femoral surgical broaches has (i) a medial/lateral broach taper angle that is the same as each of the other of the plurality of femoral surgical broaches (See paragraphs [0112]-[0113]), the medial/lateral broach taper angle being the same as the medial/lateral augment taper angle (See paragraph [0116]-[0117]), and (ii) a medial/lateral broach width (distal end) that is different from each of the other of the plurality of femoral surgical broaches (See Figs. 21-23; paragraphs [0111]-[0112], [0114], [0120] and [0127]).
Regarding claim 7, Lieberman teaches the orthopaedic system as required by claim 1 as set forth above and further teaches each of the plurality of femoral cone augments has an anterior/posterior augment taper angle (See paragraphs [0083] and [0105]-[0108]) that is the same as each of the other of the plurality of femoral cone augments (note Lieberman states the femoral sleeves have the same geometry except for the total length and the dimension of the distal bases, see paragraphs [0083] and [0099]), and
each of the plurality of femoral surgical broaches (302, 302A, and 302B) has an anterior/posterior broach taper angle that is the same as each of the other of the plurality of femoral surgical broaches (note the outer geometries of the broaches are the same over the axial length portion L (See paragraph [0110]), the anterior/posterior broach taper angle being the same as the anterior/posterior augment taper angle. (See paragraphs [0110] and [0115] which state the outer geometry of the broach is the same as the corresponding outer geometry of the augments/ sleeves)
Regarding claim 8, Lieberman teaches the orthopaedic system as required by claim 1 as set forth above and further teaches a stem trial component (See paragraphs [0072], [0078] and [00111]4) having a threaded post extending from a proximal end thereof (See Tsukayama Fig. 1; Col. 6, lines 7-14), wherein:
each of the plurality of femoral surgical broaches has a threaded aperture formed in a distal end thereof and the threaded aperture formed in each of the plurality of femoral surgical broaches is sized to threadingly receive the threaded post of the stem trial component. (See paragraph [0111] of Lieberman which expressly incorporates Tsukayama; See Col. 6, lines 15-25 of Tsukayama).
Regarding claim 9, Lieberman teaches an orthopaedic system (see, for example, Fig. 1) comprising:
a plurality of knee cone augments (24, 24A, 24B, and 24C or 224, 224A, and 224B) (See Figs 3-10, and 15-18; paragraphs [0075] and [0099]) configured5 to be implanted into a surgically-prepared cavity in a distal end of a bone of a patient’s knee, wherein each of the plurality of knee cone augments has (i) a medial/lateral augment taper angle that is the same as each of the other of the plurality of knee cone augments, (See paragraphs [0083] and [0105]-[0108]) and (ii) a medial/lateral augment width (dimension of the bases 262, 262A, and 262B) that is different from each of the other of the plurality of knee cone augments (See paragraphs [0083] and [0109]-[0110]), and
a plurality of knee surgical broaches (302, 302A, and 302B) having cutting teeth (312, 312A, and 312B) (See Figs. 21-25; paragraphs [0110]-[0112]) configured6 to cut bone to form the surgically-prepared cavity in the distal end of the bone of the patient’s knee (See paragraph [0115]), wherein each of the plurality of knee surgical broaches has (i) a medial/lateral broach taper angle that is the same as each of the other of the plurality of knee surgical broaches (See paragraphs [0112]-[0113]), the medial/lateral broach taper angle being the same as the medial/lateral augment taper angle (See paragraph [0116]-[0117]), and (ii) a medial/lateral broach width (distal end) that is different from each of the other of the plurality of knee surgical broaches (See Figs. 21-23; paragraphs [0111]-[0112], [0114], [0120] and [0127]).
Regarding claim 10, Lieberman teaches the orthopaedic system as required by claim 9 as set forth above and further teaches each of the plurality of knee cone augments has an anterior/posterior augment taper angle (See paragraphs [0083] and [0105]-[0108]) that is the same as each of the other of the plurality of knee cone augments (note Lieberman states the femoral sleeves have the same geometry except for the total length and the dimension of the distal bases, see paragraphs [0083] and [0099]), and
each of the plurality of knee surgical broaches (302, 302A, and 302B) has an anterior/posterior broach taper angle that is the same as each of the other of the plurality of knee surgical broaches (note the outer geometries of the broaches are the same over the axial length portion L (See paragraph [0110]), the anterior/posterior broach taper angle being the same as the anterior/posterior augment taper angle. (See paragraphs [0110] and [0115] which state the outer geometry of the broach is the same as the corresponding outer geometry of the augments/ sleeves).
Regarding claim 13, Lieberman teaches the orthopaedic system as required by claim 9 as set forth above and further teaches each of the plurality of knee cone augments comprises a femoral cone augment (24, 24A, 24B, and 24C or 224, 224A, and 224B) (See Figs 3-10, and 15-18; paragraphs [0075] and [0099])
Regarding claim 14, Lieberman teaches the orthopaedic system as required by claim 9 as set forth above and further teaches a stem trial component (See paragraphs [0072], [0078] and [00111]7) having a threaded post extending from a proximal end thereof (See Tsukayama Fig. 1; Col. 6, lines 7-14), wherein:
each of the plurality of knee surgical broaches has a threaded aperture formed in a distal end thereof and the threaded aperture formed in each of the plurality of knee surgical broaches is sized to threadingly receive the threaded post of the stem trial component. (See paragraph [0111] of Lieberman which expressly incorporates Tsukayama; See Col. 6, lines 15-25 of Tsukayama).
Response to Arguments
Applicant’s arguments with respect to the 112 rejections have been fully considered and are persuasive. The 35 U.S.C. 112 rejections have been withdrawn.
Applicant's arguments filed January 13, 2026 have been fully considered but they are not persuasive.
Applicant argues the applied Lieberman reference (US PG Pub 2014/0081411) cannot be relied upon because of the 112 interpretation. This is unpersuasive. Lieberman expressly teaches the “medial-lateral dimension” is the same. See paragraph [0083] which states the geometries of the femoral sleeve “are essentially identical over axial length L” and “differ only in the size of the bases and distal portions corresponding with the axial extensions”
Applicant argues that Lieberman fails to teach a “cone augment” since “a cone augment is distinct from a sleeve augment given sleeve augments are mechanically locked to a revision knee prosthesis prior to implantation of the prosthesis”. Applicant continues that since Lieberman describes the invention as “a sleeve augment” it cannot apply.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a cone augment is distinct from a sleeve augment given sleeve augments are mechanically locked to a revision knee prosthesis prior to implantation of the prosthesis) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
It is noted that the claims do not have any specific limitations which require the cone augment to have a smooth continuous outer surface, only that the taper angles is the same as the other cone augments which can clearly be seen in the Figures of Lieberman as well as in the description. (See, for example, paragraphs [0083]; [0105]-[0108]; [0110]-[0117]; and [0120])
It is further noted that even if applicant’s arguments regarding the differences between cone augments and sleeves are true, there are no limitations in the claim which require or prohibit the augment from being “mechanically locked” to a revision prosthesis prior to implantation. The claims are silent as to a revision knee prosthesis. Furthermore, It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II).
Lieberman’s disclosure anticipates applicant’s device as currently presented in the claims. As stated in MPEP §2141.01(a) “However, there is no analogous art requirement for a reference being applied in an anticipation rejection under 35 U.S.C. 102. In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997).”
Applicant’s final argument is that examiner has not sufficiently provided analysis or evidence of inherency. It is noted that since Lieberman expressly teaches all of the claimed limitations, any analysis of inherency is unnecessary.
The remainder of applicant’s arguments amount to an allegation of patentability based on the alleged deficiencies of the primary reference. For the reasons set forth above, this is unpersuasive.
Conclusion
THIS ACTION IS MADE FINAL. 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 RACHEL S. HIGHLAND whose telephone number is (571)270-3254. The examiner can normally be reached on Monday through Thursday between 9:30am and 2:30pm .
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/R.S.H/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
1 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. In the instant case, “femoral cone augments” requires only that the implant be capable of placement in the femur and be generally conical. As can be clearly seen in the Figs., the device of Lieberman fits the broadest reasonable interpretation of this limitation. It is further noted that applicant is free to add additional limitations to the claims to further define the invention.
2 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). In the instant case, Lieberman explicitly teaches implanting the sleeve into a prepared opening in the distal end of a femur (See paragraph [0086]).
3 See footnote 1 above, note Lieberman explicitly teaches the broaches are designed to cut bone to form the opening in the femur into which the sleeve is placed. (See paragraph [0115])
4 Note paragraph [0111] incorporates by reference application 13/834862 (U.S. Patent No. 9,554,810) which expressly teaches the stem trial component (18) has a threaded post 28 extending therefrom which threadingly mates with a bore in the surgical broach (20) (See Col. 6, lines 7-50)
5 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). In the instant case, Lieberman explicitly teaches implanting the sleeve into a prepared opening in the distal end of a femur (See paragraph [0086]).
6 See footnote 1 above, note Lieberman explicitly teaches the broaches are designed to cut bone to form the opening in the femur into which the sleeve is placed. (See paragraph [0115])
7 Note paragraph [0111] incorporates by reference application 13/834862 (U.S. Patent No. 9,554,810) which expressly teaches the stem trial component (18) has a threaded post 28 extending therefrom which threadingly mates with a bore in the surgical broach (20) (See Col. 6, lines 7-50)