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 1, shown in Figs. 1-6 in the reply filed on 06/15/2026 is acknowledged. Claims 1-22 are pending. Claim 6 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim.
Claim Objections
Claims 1-5 and 7-22 are objected to because of the following informalities:
In claims 1-5 and 7-22, replace “Device” for --A device--. 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 1-5 and 7-22 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, line 5 recites the limitation "at least one intraosseous screw.” There is insufficient antecedent basis for this limitation in the claim. Claims 2-5 and 7-22 are rejected as depending from a rejected base claim.
Claim 3 recites “a first stop surface, that cooperates with a corresponding surface,” and subsequently recites “is limited by a first stop surface.” It is unclear whether the second recitation refers to the previously recited first stop surface or to an additional, distinct structure.
Claim 9 recites that the adjusting device “can only be screwed into the plate as far as a predefined position,” and subsequently recites “beyond a predefined position of the adjusting device.” It is unclear whether these recite the same position or different positions, rendering the metes and bounds of the claim uncertain.
Claim 22 recites “when the device is arranged on a thigh bone.” A claim directed to an apparatus that positively recites a patient’s anatomy renders the scope indefinite, as it is unclear whether the bone is a required element of the claimed device. Examiner suggests reciting the limitation as a functional capability (e.g., “configured such that bone cement can be introduced…”).
Claims 12 and 18 recite “approximately normal,” “approximately parallel,” and “approximately cylindrical.” These are relative terms of degree. The specification does not provide a standard for ascertaining the requisite degree of approximation, and one of ordinary skill in the art would not be reasonably apprised of the scope. See MPEP § 2173.05(b).
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) 1-3, 5, 10, 13-15, 17 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Watanabe et al. (U.S. 8,939,978 B2).
Regarding claim 1, Watanabe et al. disclose a device for treating a fracture having a plate (see Fig. 42, element 150) for attaching to a thigh bone, one or more intraosseous screws (receiving in plate openings) by means of which the plate through intraosseous screw openings can be fixed to a thigh shaft, a coupling device (see Fig. 41, element 702), which is arranged proximally to the at least one intraosseous screw and by means of which the plate can be connected at a coupling device opening through the thigh shaft and a thigh neck to a thigh head, wherein the coupling device is connected to the plate with play such that the coupling device can be moved in the lateral direction relative to the plate, wherein an adjusting device (see Fig. 41, element 704) is provided which is connected to the plate, and which can be positioned at different positions relative to the plate and by means of which the play can be adjusted.
Regarding claim 2, wherein the adjusting device (704) is connected to the plate substantially rigidly in the lateral direction and the medial direction.
Regarding claim 3, wherein the coupling device (702) has a first stop surface (712 and see col. 14, lines 31-32), that cooperates with a corresponding surface (714 and see col. 14, lines 31-32) on the adjusting device and/or the plate to such effect that a movability of the coupling device relative to the plate in medial direction is limited by a first stop surface.
Regarding claim 5, wherein the coupling device has a second stop surface (last ratchet tooth located within 712 and 714 engagement – see col. 14, lines 31-32) which bears on the adjusting device when the coupling device is in the lateral end position.
Concerning claim 10, wherein the coupling device (702) is movable between limit stops (ratchet teeth) between a medial end position and a lateral end position, wherein the medial end position is defined by a first stop surface (last tooth) on the coupling device in cooperation with the adjusting device (704), and the lateral end position is defined by a second stop surface (first tooth) in cooperation with the adjusting device (see col. 14, lines 31-32).
Concerning claim 13, wherein the adjusting device (see Fig. 39, element 604) is embodied as adjusting screw and the coupling device (see Fig. 39, element 602) is embodied as bone screw, wherein a longitudinal axis of the adjusting screw (see tip portion of element 604) is aligned at an angle from 0.5 degrees to 15 degrees, to a longitudinal axis of the bone screw.
Concerning claim 14, wherein the adjusting device is embodied as adjusting screw (see Figs. 42 and 39, element 604), which is arranged in a thread in the plate and may be positioned variably by means of the thread.
Concerning claim 15, wherein the adjusting device (see Fig. 39, element 604) is positionable variably along an adjustment direction relative to the plate (see Fig. 42, element 150).
Concerning claim 17, wherein the coupling device (see Fig. 41, element 702) has a shoulder (712), wherein the shoulder forms a second stop surface, which bears on the adjusting device (see Fig. 41, element 704) in a lateral end position of the coupling device.
Concerning claim 21, wherein a longitudinal axis of the coupling device is aligned at a femoral neck angle (γ) from 10 degrees to 60 degrees relative to a longitudinal axis of the intraosseous screw (see Fig. 42 where the intraosseous screw is received within the plate openings).
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watanabe et al. (U.S. 8,939,978 B2) as applied to claim 1 above, in view of Hansson (U.S. 2018/0177538 A1) (as cited in the IDS filed 07/30/2024).
Watanabe et al. disclose the invention substantially as described above. However, Watanabe et al. do not explicitly disclose that the coupling device has a collar laterally which cooperates with the plate to form a limit stop, up to which the coupling device may be advanced into the plate medially.
Hansson disclose a device for treating a fracture comprising a collar laterally which cooperates with the plate to form a limit stop (see Fig. 7, near element 10aa), up to which the coupling device may be advanced into the plate medially
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Watanabe’s device to includes a collar laterally which cooperates with the plate to form a limit stop, the concept of which is disclosed by Hansson, in order to fix the travel boundary for the components. Without the limit stop over-compression could occur.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watanabe et al. (U.S. 8,939,978 B2) as applied to claim 1 above, in view of Kuramoto (JP 2004097446) (as cited in the IDS filed 07/30/2024).
Watanabe et al. disclose the invention substantially as described above. However, Watanabe et al. do not explicitly disclose a traction bolt arranged parallel to a longitudinal axis of the coupling device.
Kuramoto discloses a device having a traction bolt (see Fig. 1, element 4) arranged parallel to a longitudinal axis of a coupling device (see Fig. 1, element 3) in the same field of endeavor the for the purpose of enhancing security of the device to the bone.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Watanabe’s implant to include a traction bolt, as disclosed by Kuramoto, in order to enhance the security of the device to bone thereby reducing the chance of revision surgery.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watanabe et al. (U.S. 8,939,978 B2) as applied to claim 1 above, in view of Rakes et al. (U.S. 12,453,585 B2).
Watanabe discloses the invention substantially as described above. However, Watanabe et al. do not explicitly disclose that the coupling device is of hollow design, so that bone cement can be introduced into the region of the thigh head through the coupling device when the device is arranged on a thigh bone.
Rakes et al. teach a coupling device of hollow design (see Fig. 5, element 138) in the same field of endeavor.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Watanabe’s coupling device to be cannulated, as taught by Rakes et al., because provision of a hollow/cannulated coupling device permitting introduction of bone cement into the region of the thigh head is a well-known augmentation technique for improving fixation purchase in osteoporotic femoral heads, and would have been obvious to incorporate for that predictable benefit.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at 571 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773
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