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 .
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first threaded section of the first pushing rod section comprises external screw threads (claim 14) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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
Claims 11 and 14 are objected to because of the following informalities:
Claim 11, remove “comprises” at the end of the sentence.
Claim 14, “first thread section” should be “first threaded section” for consistency purposes.
Appropriate correction is required.
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.
Claim(s) 1-7, 9-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (CN 112790849 A) in view of Pham et al. (US Publication No. 2018/0071000 A1)
Regarding Claim 1, Huang discloses a device (fig. 5) comprising:
an external screw (21+22) comprising: a first channel extending along a longitudinal axis (shown in Fig. 6- channel accepts part 12), and the first channel comprising a first inner side (wall of hexagonally shaped channel, see Fig. 3-4); and
an internal screw (11+12+13) comprising: a first pushing rod section (12) comprising a first threaded section (shown accepting threaded element 31 in Fig. 4) and the first pushing rod section is configured to slide within the first channel along the longitudinal axis (fig. 3-4) (“In addition, the inner core 11 and the outer sleeve 21 are connected by a connecting structure, the combination of the two makes the inner core 11 has relative sliding movement, and the distance-limiting structure can prevent excessive sliding, promoting the femoral neck breaking end healing, and maintaining the femoral neck length.”).
Huang is silent to the first channel having at least one protrusion which accommodates at least one groove of the internal screw. However, Huang discloses that the sliding connection between the internal and external screws has a corresponding keyed connection- a hexagonal channel and prism- to prevent the relative rotation of the internal and external screws.
Pham discloses an orthopedic screw in the same field of endeavor which comprises a keyed sliding connection wherein the male component (124) has at least one groove (130) which accept at least one protrusion (162) from a female component (134) in order to prevent relative rotation of the parts and transmit torque [0046, 0049, 0062] (Fig. 1, 3) .
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the hexagonal shaped keyed connection of Huang with the keyed connection taught by Pham (grooved male component and protrusions on a female component) in order to use a predictable configuration which would allow sliding yet prevent relative rotation of the two parts during operation.
Regarding Claim 2, Huang discloses the first pushing rod section of the internal screw further comprises a second channel, the second channel comprises a second inner side, and the first threaded section is located on the second inner side (see below).
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Regarding Claim 3, Huang discloses the second channel is configured to accommodate a length adjuster (31), the length adjuster comprises a knob (proximal portion which engages a tool for turning), a smooth section (see figure below )and a second threaded section (lower distal section, see figure below), and the second threaded section is compatible with the first threaded section (shown engaged in Fig. 4).
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Regarding Claim 4, the first channel comprises a first region and a second region, a diameter of the first region is greater than a diameter of the second region, and the diameter of the second region is smaller than a diameter of the knob (at location 24, see figure below).
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Regarding Claim 5-6, Huang discloses the external screw comprises a first continuous protrusion part (22), and the internal screw comprises a second continuous protrusion part (13) (Fig. 5), which are screw threads (Fig. 5)
Regarding Claim 7, a first spacing of the first continuous protrusion part (22) is different from a second spacing of the second continuous protrusion part (13) (“the second outer screw thread 22 and the first outer screw thread 13 thread pitch is different”, “the outer sleeve 21 of the second outer thread 22 of the thread pitch is less than the inner core 11 of the first outer thread 13 of the thread pitch”)
Regarding Claim 9, the device of Huang as modified by Pham is described above. Pham teaches that the plurality of protrusions is evenly distributed on the circumference of the channel in the female member [0062, Pham].
Regarding Claim 10, Pham shows two protrusions separated by 180 degrees but contemplates four protrusions [0062]. It would have been obvious to use four grooves/protrusions as taught by Pham and space them evenly in order to symmetrically apply torque from one component to the other.
Regarding Claim 11, the device of Huang as modified by Pham is described above. Pham teaches that the plurality of grooves is evenly distributed on the circumference of the sliding surface of the male member [0046, Pham].
Regarding Claim 12, Pham shows two grooves separated by 180 degrees but contemplates four grooves [0046]. It would have been obvious to use four grooves/protrusions as taught by Pham and space them evenly in order to symmetrically apply torque from one component to the other.
Regarding Claim 13, Huang discloses wherein an adjustable sliding distance of the internal screw relative to the external screw is no more than 2 cm (“the outer sleeve is provided with a limited distance structure; to limit the relative sliding distance of the inner core and the outer sleeve”, “the limiting structure limits the sliding range of the inner core 11 to be 5mm”).
Regarding Claim 14, the device of Huang in view of Pham depicts the first thread[ed] section has having internal (female) threads which engage external (male) threads of the length adjuster (31). However, it would have been obvious to one having ordinary skill in the art to reverse the male/female connection and have external threads on the first threaded section and internal threads on the length adjuster since reversal of a male/female connection would be an obvious alternative of a threaded connection. In re Gazda, 219 F.2d 449, 104 USPQ 400.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (CN 112790849 A) in view of Pham et al. US Publication No. 2018/0071000 A1) in further view of Carrier (US Publication No. 2021/0212739)
Huang in view of Pham discloses the device as described in the rejection of claim 1 above. However, Huang in view of Pham is silent to the material of the internal and external screw.
Carrier teaches a bone screw in the analogous art of orthopedic fasteners and teaches either Ti-6Al-4V or stainless steel are suitable materials to make the fastener from [0035].
It would have been obvious to one having ordinary skill in the art before the effective filing date to use Ti-6Al-4V or stainless steel as the material for the device of Huang in view of Pham since Carrier teaches that these are suitable materials to create bone fasteners.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (CN 112790849 A) in view of Pham et al. US Publication No. 2018/0071000 A1) in further view of Zastrozna (US Publication No. 2020/0093525 A1).
Regarding Claim 8, Huang discloses that the pitch of the first thread 22 (proximal thread) is less than the pitch of the second thread 13 (distal thread) (“the outer sleeve 21 of the second outer thread 22 of the thread pitch is less than the inner core 11 of the first outer thread 13 of the thread pitch”), however is silent to the ratio being specifically 1:2.
Zastrozna teaches a bone screw in the analogous art of orthopedic fasteners and teaches different proximal and distal threads. Zastrozna teaches that the ratio of the distal pitch P1 to the proximal pitch P2 can be about 2:1 [0036].
It would have been obvious to one having ordinary skill in the art before the effective filing date to create the distal to proximal pitch ratio of the device of Huang in view of Pham as 1:2 since Zastrozna teaches that this is a suitable ratio for compression bone fasteners with dual threaded ends.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (CN 112790849 A) in view of Pham et al. US Publication No. 2018/0071000 A1) in further view of Jackson (US Publication No. 2011/0015683 A1).
Regarding Claim 17, Huang discloses providing a device, the device comprising an internal screw (11+12+13) and an external screw (21+22), the external screw comprising a first channel configured to accommodate a length adjuster (31) (Fig. 4-6), the internal screw comprising a first pushing rod section (12), the first pushing rod section (12) comprising a second channel (see figure above with regards to claim 2 rejection), a second inner side of the second channel comprising internal screw threads (accepting threads of 31, Fig. 4),;
inserting the first pushing rod section of the internal screw into the first channel of the external screw, the internal screw and the external screw being slidable relative to each other (Fig.4);
placing the length adjuster (31) in the first channel of the external screw, the length adjuster being provided with a second thread section which comprises external screw threads, and the external screw threads on the second thread section being made compatible with the internal screw threads of the first pushing rod section (fig. 4);
rotating the length adjuster to adjust a sliding distance of the internal screw relative to the external screw (31 limits the length of sliding and it is screwed into the proximal end (first threaded section of the internal screw).
Huang is silent to 1) the first channel having at least one protrusion which accommodates at least one groove of the internal screw. However, Huang discloses that the sliding connection between the internal and external screws has a corresponding keyed connection- a hexagonal channel and prism- to prevent the relative rotation of the internal and external screws, and 2) the step of removing the length adjuster (31).
Pham discloses an orthopedic screw in the same field of endeavor which comprises a keyed sliding connection wherein the male component (124) has at least one groove (130) which accept at least one protrusion (162) from a female component (134) in order to prevent relative rotation of the parts and transmit torque [0046, 0049, 0062] (Fig. 1, 3) .
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the hexagonal shaped keyed connection of Huang with the keyed connection taught by Pham (grooved male component and protrusions on a female component) in order to use a predictable configuration which would allow sliding yet prevent relative rotation of the two parts during operation.
Jackson discloses a bone screw assembly in the analogous art of orthopedic fasteners. Jackson discloses that the bone screw assembly is disassembled by unscrewing its components in reverse order if removal is necessary [0069].
It would have been obvious to remove the length adjuster of Huang in order to remove the assembly as taught by Jackson in situations where the implant has failed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Form PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
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/JACQUELINE T JOHANAS/ Primary Patent Examiner, Art Unit 3773