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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “434” has been used to designate both second end (¶ [0038]) and threads (¶ [0038]). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 3 objected to because of the following informalities: “A length of interface” should read “a length of the interface” in lines 1-2. 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 14-15 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 14 recites “the third portion” in line 2 and “the second portion” in line 3 in relation to the proximal body. However, the third portion and the second portion of the proximal body have not been positively recited. It is unclear if the third and second portions are intended to be the same third and second portions of the receiving section in claim 12 or if they are additional and separate third and second portions of the proximal body. Dependent claim 15 is likewise rejected.
Claim 15 recites “the receiving portion” in line 4. It is unclear if this is referring to the receiving portion 122 noted in ¶ [0050] of the specification or if this is referring to be the receiving section recited in claim 1. If it is intended to be the receiving portion, there is a lack of antecedent basis. If it is intended to be the receiving section from claim 1, the word “portion” should be replaced with “section” for clarity.
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) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sederholm (US 2005/0004679 A1).
Regarding claim 1, Sederholm teaches a hip prosthesis (10, hip prothesis, fig. 1), comprising:
an elongated stem including a receiving section (14, proximal body, fig. 1) and a body section (12, stem, fig. 1), the receiving section having a bore (86, bore, fig. 6C);
a proximal body (16, neck, fig. 1) having a neck (52, neck portion, fig. 4B) and a calcar section (50, base portion, fig. 4B); the calcar section including a through hole (60 and 62, cylindrical bore and second bore, fig. 4B);
an interface (18, sleeve, fig. 1) configured to be disposed on the receiving section between the body section and the proximal body when the stem and the proximal body are assembled (fig. 2), the interface including an opening (104, bore, fig. 7D);
one or more fastener components (70, screw, fig. 1) configured to be disposed within the through hole of the proximal body (fig. 2) and the bore of the receiving section when the stem and the proximal body are assembled (The phrase “one or more fastener components configured to be disposed within . . . the bore of the receiving section when the stem and the proximal body are assembled” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the screw is considered to be capable of passing through the cylindrical bore 86 of the proximal body 14 while assembling the prothesis 10 by attaching the stem 12 to the neck 16.) so as to fasten or mate the elongated stem and the proximal body (¶ [0055]); and
wherein when the stem and the proximal body are assembled and mated, the proximal body is configured to radially rotate about the interface with respect to the elongated stem (fig. 9, ¶ [0064]).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sederholm in view of Gordon (US 2021/0077260 A1).
Regarding claim 2, Sederholm fails to teach the interface is a polyethylene bushing. However, Gordon discloses a bone prosthesis with a rotatable portion that teaches a polyethylene bushing (210, bushing, fig. 2). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the interface of Sederholm to include a polyethylene bushing as taught by Gordon in order to in order to allow rotation without translation (¶ [0044], Gordon).
Regarding claim 3, Sederholm further teaches a length of interface is longer than a length of the through hole (fig. 1).
Regarding claim 4, Sederholm further teaches when the stem and proximal body are mated and fastened, a portion of the interface between the proximal body and the body section is exposed. It would have been an obvious matter of design choice to have a portion of the interface between the proximal body and the body section is exposed, since applicant has not disclosed that having a portion of the interface between the proximal body and the body section is exposed solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with a portion of the interface being partially exposed or not. Further it is obvious to try. There are a finite number of layouts of the interface. When the stem and proximal body are mated and fastened, a portion of the interface will be exposed or will not be exposed.
Regarding claim 5, Sederholm further teaches a bolt (70, screw, fig. 5C, Mirriam-Webster defines bot as “a metal rod or pin for fastening objection together hat usually has a head on one end and a screw thread at the other end and is secured by a nut, in this case the threaded cylindrical bore 34 would act as the nut), the bolt including a head (72, head portion, fig. 5C) and a shaft (74, shaft, fig. 5C).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sederholm in view of Gordon as applied to claim 5 above, and further in view of McCarthy (US 7,425,241 B1).
Regarding claim 6, Sederholm and Gordon fail to teach a mounting member with a through hold through which a bone is configured to be disposed. However, McCarthy discloses a connection within a hip prosthesis that teaches a mounting member (74, sleeve, fig. 7) having a through hole through which a bolt is configured to be disposed when assembled (fig. 6). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the fastener components of Sederholm and Gordon to include a mounting member with a through hole which a bolt is configured to be disposed as taught by McCarthy in order to reduce friction between components as the drive shaft rotates and since it is a use of a known technique to improve similar devices (methods, or products) in the same way, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Regarding claim 7, Sederholm and Gordon fail to teach the mounting member is a boss. However, McCarthy further teaches the mounting member is a boss (fig. 7). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the mounting member of Sederholm and Gordon to include the mounting member is a boss as taught by McCarthy in order to reduce friction between components as the drive shaft rotates and since it is a use of a known technique to improve similar devices (methods, or products) in the same way, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sederholm in view of Gordon and McCarthy as applied to claim 6 above, and further in view of Bassik (US 7,135,044 B2).
Regarding claim 8, Sederholm and Gordon fail to teach the mounting member includes one or more sections. However, McCarthy further teaches the one or more section includes a first section (see annotated fig. 7, below), a second section (see annotated fig. 7, below), and a third section (see annotated fig. 7, below); a first section has an outer diameter that is larger than an outer diameter of the second section (fig. 7). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the mounting member of Sederholm and Gordon to include the mounting member includes one or more sections as taught by McCarthy in order to reduce friction between components as the drive shaft rotates and since it is a use of a known technique to improve similar devices (methods, or products) in the same way, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
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Sederholm, Gordon and McCarthy fail to teach the third section has an outer diameter with a shape that is different than the first and second sections. However, Bassik discloses a modular hip prosthesis that teaches the third section has an outer diameter having a shape that is different from a shape of the outer diameter of the first section and a shape of the outer diameter of the second section (32, tab, fig. 3, col 6 lines 21-53). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the third section of the mounting member to include a different shape as taught by Bassik in order to permit a taper lock (col 6 lines 21-45, Bassik).
Regarding claim 9, Sederholm and Gordon fail to teach the mounting member has a length that is shorter than a length of a shaft of the bolt so that the shaft of the bolt extends past the mounting member when disposed in the mounting member. However, McCarthy further teaches the mounting member has a length that is shorter than a length of a shaft of the bolt so that the shaft of the bolt extends past the mounting member when disposed in the mounting member (figs. 6-7). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the mounting member of Sederholm and Gordon to include the mounting member has a length that is shorter than a length of a shaft of the bolt so that the shaft of the bolt extends past the mounting member when disposed in the mounting member as taught by McCarthy in order to reduce friction between components as the drive shaft rotates and since it is a use of a known technique to improve similar devices (methods, or products) in the same way, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Allowable Subject Matter
Claims 10-13 and 16-17 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art Sederholm (US 2005/0004679 A1) fails to teach alone or in combination a hip prostheses comprising an elongated stem an elongated stem including a receiving section and a body section, the receiving section having a bore; a proximal body having a neck and a calcar section; the calcar section including a through hole; an interface configured to be disposed on the receiving section between the body section and the proximal body when the stem and the proximal body are assembled, the interface including an opening; a bolt and a mounting member having a through hole configured to be disposed within the through hole of the proximal body and the bore of the receiving section when the stem and the proximal body are assembled so as to fasten or mate the elongated stem and the proximal body; and wherein when the stem and the proximal body are assembled and mated, the proximal body is configured to radially rotate about the interface with respect to the elongated stem the through hole of the proximal body includes one or more sections, the one or more sections including a first section and a second section; and when the proximal body and the stem are assembled, the second section is configured to be disposed so as to surround the interface and the receiving section. Dependent claims 11-13 and 16-17 are likewise objected.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799