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 .
Election/Restrictions
Applicant’s election without traverse of Species B in the reply filed on 11/7/2025 is acknowledged. The requirement is deemed proper and is therefore made FINAL.
Claim Objections
Claim 4 is objected to because of the following informalities: claim 4 recites “an inclination of said frontal wall.” Claim 4 should use a definite article for this element since the antecedent basis of this inclination was established in claim 3. 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.
Claim 10 and its 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 10 is dependent upon cancelled claim 8, and therefore, the metes and bounds of claim 10 cannot be properly determined. Appropriate correction 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, 2, and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blaylock et al. (Pub. No.: US 2004/0162619 A1; hereinafter “Blaylock”).
Blaylock discloses the following regarding claim 1: an augment element for tibial applications in a knee prosthesis, said augment element (10) comprising a metal body (para. 0042) of a substantially truncated conical shape (Figs. 1-6C) configured to be inserted into a bone extremity (paras. 0042-0043) and having an outer surface comprising a metal trabecular surface (para. 0042), said metal body being hollow (Figs. 1-2, 5) with an axial through-cavity (central through opening) defining a plurality of substantially annular transversal sections (upper and lower sections of element 10), wherein said metal body is inclined in a direction of inclination (direction of any of any of the tapered inclinations on element 10) (paras. 0046, 0048-0049), so as to define at least one eccentricity (tapering) between a first transversal section (upper transversal section) at a first end (upper end) of said axial through-cavity (Figs. 1, 3) and a second transversal section (lower transversal section) at a second end (lower end) of said axial through-cavity (Figs. 1, 3), wherein said first transversal section at said first end is larger in size than said second transversal section at said second end (Fig. 3, as the first, upper section is wider than the second, lower section), and wherein said metal body comprises lateral walls (walls of elements 24, 26) having respective curved and concave shapes with respect to the outside of said metal body (Figs. 1-2, 5; para. 0044), to replicate a medial/side and rear bone anatomy (Figs. 1-2, 5; paras. 0042-0045).
Blaylock discloses the following regarding claim 2: the augment element according to claim 1, wherein said axial cavity has a longitudinal axis (lengthwise axis positioned at the angle of incline of any of the tapered sections of element 10) (Fig. 3) inclined in said direction of inclination with respect to a vertical axis of said metal body (paras. 0046, 0048-0049), said vertical axis (lengthwise axis positioned straight through element 10) (Figs. 3, 6A-6C) being perpendicular to one of said first or second transversal section (as a transverse plane through the upper or lower sections will be perpendicular to the lengthwise, straight axis) (Figs. 3, 6A-6C).
Blaylock discloses the following regarding claim 18: the augment element according to claim 1, wherein said metal body comprises a smooth edge (edges lacking protrusions) on said outer surface surrounding said metal trabecular surface (Figs. 1-5; para. 0042).
Blaylock discloses the following regarding claim 19: the augment element according to claim 1, wherein said metal trabecular surface is made in one piece and seamlessly with said metal body (Figs. 1-5; para. 0042).
Blaylock discloses the following regarding claim 20: the augment element according to claim 1, wherein said metal body comprises walls having a substantially constant thickness (para. 0046).
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) 3-4 and 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blaylock.
Blaylock teaches the following regarding claim 3: the augment element according to claim 2, wherein said metal body comprise a frontal wall (anterior wall on element 16) extending towards said direction of inclination (Figs. 3-5, as the wall extends at an angle towards the tapering angle of element 22) and further comprises a rear wall (back wall of element 20) opposite said frontal wall (Figs. 3-5) and extended away from said direction of inclination (Figs. 3-5, as the outer wall extends at an angle away from the tapering angle of element 22).
Regarding claims 3, 4, and 6, Blaylock does not explicitly recite that the frontal wall has an inclination with respect to said vertical axis that is less than an inclination of said rear wall; and that the inclination of said frontal wall with respect to said vertical axis is comprised between 0° and 5°. Blaylock teaches that the dimensions of its implant may be modified and a variety of implants are provided in order to properly fit a particular patient’s anatomy (paras. 0042-0054). The optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal dimensions and tapering angles needed to achieve the desired results and properly fit a specific patient anatomy. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the dimensions and tapering angles of the augment, would have been obvious at the time of applicant's invention in view of the teachings of Blaylock. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
Blaylock teaches the following regarding claim 6: the augment element according to claim 4, wherein for tibial applications an inclination of said rear wall with respect to said vertical axis is comprised between 15° and 20° (Fig. 4; para. 0049).
Blaylock teaches the following regarding claim 7: the augment element according to claim 6, wherein said rear wall further has a curved and concave shape with respect to the outside of said metal body, to replicate a tibial bone rear anatomy (Figs. 1-2, 5; paras. 0042-0054).
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blaylock in view of German et al. (Patent No.: US 7,291,174 B2; hereinafter “German”).
Blaylock teaches the limitations of the claimed invention, as described above. It further teaches the upper, first transversal section being bilobed annular (at the upper, left and right halves) (Figs. 1-2, 5); and said outer surface of said metal body being tapered between said first transversal section and said second transversal section (paras. 0046, 0048-0049). However, it does not recite a pair of cutouts arranged at said lateral walls to open from said first end up to an intermediate portion on said metal body, and the second transversal section being circular annular. German teaches that it is well known in the art that a tibial augment device is provided with a pair of cutouts arranged at the inner and outer lateral walls to open from a first, upper end to an intermediate portion (area of the augment between the upper end and the lower end) on the body (Figs. 10, 12, 14-15); and a second, lower transversal section having a circular annular shape (Figs. 10-12). This construction allows the augment to accommodate additional implants applied to the knee and/or to accommodate the shape and volume of the patient’s bone at the implantation site (col. 4, lines 23-col. 5, lines 27). It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the shape of the augment of Blaylock to comprise the cutouts and the circular annular shape, taught by German, in order to accommodate additional implants applied to the knee and/or to accommodate the shape and volume of the patient’s bone at the implantation site. Such a modification would be made with a reasonable expectation of success.
Conclusion
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).
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/ANN HU/Primary Examiner, Art Unit 3774