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 .
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 1 recites the limitations "the rotation of a first generatrix" in line 4 and “the rotation of a second generatrix” in line 5. There is insufficient antecedent basis for these limitations in the claim.
Claim 4 recites the limitations "the extension of said first and second external surfaces" in line 2 and “the extension of said first and second portions” in line 3. There is insufficient antecedent basis for this limitation in the claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 5 recites the broad recitation “between 0 and 5”, and the claim also recites “preferably between 0.20 and 3” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Additionally, claim 5 recites the term “preferably”. It is unclear if the “preferable” ratio is required or an optional limitation.
Claim 6 recites the limitations “the ratio” in line 2 and "the prolongation" in lines 3-4. There is insufficient antecedent basis for these limitations in the claim.
Claims 2-3 and 7-18 are rejected under 35 U.S.C. 112(b) as they depend from a rejected base claim and do not rectify the issue(s) at hand.
Claim Interpretation
The claimed phrases “obtained by the rotation of a first generatrix” claim 1, “obtained by the rotation of a second generatrix” in line 1, “cutting” in claim 8, and “by means of additive printing technology” in claims 12-13are being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. With regard to claims 1-18, it is noted that the device of Bonitati and Dickerson appear to be substantially identical to the device claimed, although produce by a different process, therefore the burden is upon the applicant to come forward with evidence establishing an unobvious difference between the two. In re Marosi, 218 USPQ 289 (Fed. Cir. 1983).
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.
Claims 1-3, 5-7 and 11-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dickerson (US 8,623,093).
Regarding claim 1, Dickerson discloses sleeve for a prosthetic implant able to be implanted in a bone, wherein said sleeve comprises an external wall (119) defined by a first portion (see figure below) and a second portion (see figure below), and which has, on said first portion, a first external surface (see figure below) obtained by the rotation of a first generatrix (A, see figure below) about a first longitudinal axis (X, see figure below), and, on said second portion, a second external surface (see figure below) obtained by the rotation of a second generatrix (B, see figure below) about a second longitudinal axis (Y, see figure below), wherein said longitudinal axes are reciprocally inclined by an angle of inclination (see figure below), and in that at least said second external surface (13b) is at least partly concave toward the inside of said sleeve (figure 6, the cylindrical shape forms a concave inside surface).
Regarding claim 2, Dickerson discloses said first generatrix consists of a set of polynomials connected to each other, and said second generatrix is an arc of circumference, parabola, ellipse, hyperbolae, or a curve consisting of a set of polynomials connected to each other (if one chooses to form the sleeve in this manner).
Regarding claim 3, Dickerson discloses the first generatrix is a broken line or a straight line parallel to said first longitudinal axis (see figure below), and said second generatrix is concave toward the inside of the sleeve (see figure below, due to its cylindrical shape).
Regarding claim 5, Dickerson discloses the ratio between the extension of said first and second external surfaces (13a, 13b) is comprised between 0 and 5, preferably between 0.20 and 3 (figure 6).
Regarding claim 6, Dickerson discloses the external surface of said external wall also consists of, in addition to said first and second external surfaces, a third external surface (see figure below) obtained by the prolongation, along said first longitudinal axis, of the profiles of said second portion (figure 6).
Regarding claim 7, Dickerson discloses the rotation of said first and second generatrices generates a first and a second volume which define at least said first and second external surfaces respectively, wherein the external surface of said sleeve consists of a part of the external surface of a final volume constituted by the union of said first and second volumes (figure 6).
Regarding claim 11, Dickerson discloses the second portion is provided with one or more through holes (126’s) which can have a cylindrical, elliptical or spline section (figure1A). Regarding claim 12, Dickerson discloses the external wall comprises a solid part (110) and a part with a trabecular structure (119, column 6, lines 21-38), and in that both said solid part and also said part with a trabecular structure are made in single body by means of additive printing technology.
Regarding claim 13, Dickerson discloses the entire external wall has a trabecular structure (column 6, lines 21-38) and is made in a single body by means of additive printing technology. Regarding claim 14, Dickerson discloses an internal surface (see figure below) able to allow a coupling with an intermediate component (e.g. 102) of a prosthetic implant which, in turn, is configured to couple with a rod (e.g. 130) of said prosthetic implant (figure 1A, 3, 7A).
Regarding claim 15, Dickerson discloses a modular prosthetic assembly (figure 1A) comprising at least three component modules (102, 110, 130) able to be coupled together (figure 7A), of which at least one intramedullary rod (130) and an intermediate neck component (102) able to be associated with said rod (figure 7A) and with a prosthetic head (H, figure 7A), said at least one rod and intermediate neck component being comprised in a prosthetic implant; a sleeve as in claim 1 (110), configured to stably couple to said intermediate neck component (figure 1A).
Regarding claim 16, Dickerson discloses a modular prosthetic assembly (figures 1A, 3, 7A) as in claim 15, wherein at least said rod, said intermediate neck component and said sleeve are distinct and separate component modules able to be connected to each other in a selectively decouplable manner (figures 1A, 3, 7A).
Regarding claim 17, Dickerson discloses wherein it also comprises said prosthetic head (H, figure 7A). Regarding claim 18, Dickerson discloses wherein said rod, said intermediate component and said sleeve are provided with modular sizes (column 3, lines 37-59, column 8, lines 49-62).
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Claims 1, 4 and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bonitati (US 2013/0304220).
Regarding claim 1, Bonitati discloses sleeve for a prosthetic implant able to be implanted in a bone, wherein said sleeve comprises an external wall (216) defined by a first portion (see figure below) and a second portion (see figure below), and which has, on said first portion, a first external surface (206’s 216) obtained by the rotation of a first generatrix (A, see figure below) about a first longitudinal axis (X, see figure below), and, on said second portion, a second external surface (208’s 216) obtained by the rotation of a second generatrix (B, see figure below) about a second longitudinal axis (Y, see figure below), wherein said longitudinal axes are reciprocally inclined by an angle of inclination (see figure below), and in that at least said second external surface (13b) is at least partly concave toward the inside of said sleeve (figure 14 @236).
Regarding claim 4, Bonitati discloses that the extension of said first and second external surfaces is variable, and it depends on the extension of said first and second portions, respectively (figure 14).
Regarding claim 8, Bonitati discloses sad part is obtained by "cutting" said final volume along two cutting planes (T1, T2, see figure below) which are axially distanced along said first longitudinal axis (see figure below).
Regarding claim 9, Bonitati discloses said cutting planes (T1, T2) are parallel to each other (see figure below).
Regarding claim 10, Bonitati discloses that at least one of said cutting planes (T1, T2) has a step-shaped profile (see figure below, stepped at first terrace 218).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00.
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/MATTHEW J LAWSON/ Primary Examiner, Art Unit 3619
