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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claim 6 is provisionally rejected on the ground of nonstatutory double patenting as being anticipated by claim(s) 1, 5-7 and 12-15 of copending Application No. 18/391321. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the co-pending Application claims lies in the fact that the patent claims include many more elements and are thus much more specific as shown below (note that underlined and/or bolded sections indicate comparable elements):
Invention 18391064
Application 18/391321
6. An external fixation strut comprising: an elongated body having a variable length; at least a sensor embedded into the elongated body and able to detect at least a variation in length of the elongated body.
Claims 1, 5-7, 14 and 15:
1. An external fixation strut, comprising: an elongated body comprising at least a first shaft and a second shaft moveable with respect to each other to modify the length of said elongated body; at least a sensor integrated in the external fixation strut and adapted to perform at least a measurement which is indicative of the length of the elongated body; wherein the sensor communicates with a programmable tool for lengthening/shortening the external fixation strut through a data port which is engageable by said programmable tool, wherein the sensor uses either an inductive or a capacitive technology to determine the position of a movable element, wherein the movable element is an end-piece of the second shaft or a metering cursor which translates with the end-piece with respect to the second shaft, wherein the end-piece is slidable within a tubular body of the first shaft, wherein the sensor comprises a sensing strip arranged within the tubular body of the first shaft, wherein the sensing strip is a flexible printed circuit board, and it is attached on top of a rigid support plate, wherein the rigid support plate is made of ferromagnetic material and at least partly shields the sensing strip from external noise, wherein a longitudinal slit is provided at least internally along the tubular body of the first shaft, the sensing strip and the rigid support plate being inserted in said longitudinal slit.
12. An external fixation strut, comprising: an elongated body comprising at least a first shaft and a second shaft moveable with respect to each other to modify the length of said elongated body; at least a sensor integrated in the external fixation strut and adapted to perform at least a measurement which is indicative of the length of the elongated body, wherein the sensor communicates with a programmable tool for lengthening/shortening the external fixation strut through a data port which is engageable by said programmable tool The external fixation strut of claim 9, wherein the sensor uses either an inductive or a capacitive technology to determine the position of a movable element, wherein the movable element is an end-piece of the second shaft or a metering cursor which translates with the end-piece with respect to the second shaft, wherein the end-piece is slidable within a tubular body of the first shaft, wherein the sensor comprises a sensing strip arranged within the tubular body of the first shaft, wherein the sensing strip is a flexible printed circuit board, and it is attached on top of a rigid support plate, wherein the second shaft comprises a casing having a tubular body and a protruding portion extending beyond the diameter of said tubular body, the protruding portion housing an electronic board for sensor powering and data transmission which is not aligned with the sensing strip, the electronic board being connected to the sensing strip through a flexible signal line.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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) 1, 2, 5 and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross (WO2009105479A1).
With respect to claim 1, Ross discloses a programmable wrench (10, see para. 55) for automatically adjusting the length of external fixation struts (see abstract and fig. 1 below), the programmable wrench comprising: a mechanical connector (30) meant to releasably engage with the external fixation strut (e.g., via 60, see para. 31-32) thus enabling transmission of at least an adjustment torque from the programmable wrench to the external fixation strut (see para. 29-34, fig. 3 below); an electrical connector (e.g., 76 or 78, see fig. 6 below) meant to releasably connect with the external fixation strut thus enabling at least a data transmission from the external fixation strut to the programmable wrench (see para. 33); wherein the mechanical connector and the electrical connector are integrated in a common port (e.g., 58) and are jointly engaged and disengaged with the external fixation strut (see fig. 6 below).
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As for claim 2, Ross further discloses the programmable wrench according to claim 1, wherein the electrical connector further enables power transmission from the programmable wrench to the external fixation strut (see para. 29, 30, 33).
With respect to claim 5, Ross discloses an external fixation strut (52) comprising: an elongated body having a length variable through a rotatable adjustment mechanism (e.g., note threaded connection in fig. 3 above of members of 52 between rings 56 and 54, see para. 34); a mechanical connector (e.g., at 60) of the adjustment mechanism meant to releasably engage with a programmable wrench (10, see para. 55) thus enabling transmission of at least an adjustment torque from the programmable wrench to the external fixation strut (see para. 34); an electrical connector (e.g., 70, 72, see fig. 6 above) meant to releasably connect with the programmable wrench thus enabling data and/or power transmission between the external fixation strut and the programmable wrench (see para. 34); wherein the mechanical connector and the electrical connector are integrated in a common port (at 58) and are jointly engaged and disengaged with the programmable wrench (see para. 34).
With respect to claim 11, Ross discloses a programmable wrench (10, see para. 55) for automatically adjusting the length of external fixation struts of an external fixation system (see para. 29-34), wherein said programmable wrench is adapted to: acquire prescription data relating to a determined patient's case and comprising instructions for performing an adjustment of the external fixation strut of the patient (see para. 29-34); guide a user toward performing the adjustment of the external fixation struts according to said prescription data (see para. 29-34); updating a status of the external fixation system according to the readings of length sensors embedded in each external fixation strut (see para. 29-34).
As for claim 12, Ross further discloses the programmable wrench according to claim 11, wherein the step of guiding a user toward performing the adjustment of the external fixation struts includes at least a sub-step of indicating to the user which external fixation strut has to be adjusted (see para. 29-34).
As for claim 13, Ross further discloses the programmable wrench according to claim 12, wherein, in the step of guiding a user toward performing the adjustment of the external fixation struts, the wrench is activated in a direction and for a time which are automatically calculated in view of the strut currently engaged and of the updated prescription data (see para. 29-34).
As for claim 14, Ross further discloses the programmable wrench according to claim 13, wherein the activation time is feedback controlled according to the reading of the length sensor of the engaged external fixation strut (see para. 29-34).
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross (WO2009105479A1), as applied to claim 1 above, in view of Ferrante (WO2021061816A1).
As for claims 3 and 4, Ross teaches electrical connectors (70, 72, 74, 76) but does not teach wherein the electrical connector defines a wired contact with the external fixation strut, a first pole being connected via an inner connector, a second pole being connected via an outer connector; and wherein the inner connector is a pogo-pin, and the outer connector is a metal spring.
Ferrante, also drawn to automated external fixators (see abstract), teaches wherein the electrical connector defines a wired contact (e.g. pogo pin connector and socket assemblies) with the external fixation strut (see para. 140-144), a first pole being connected via an inner connector (e.g., pogo pin- note 3502), a second pole being connected via an outer connector (e.g., pogo socket 3504) (see para. 140-144); and wherein the inner connector is a pogo-pin, and the outer connector is a metal spring (see para. 127 and 144, fig. 4q, note that it is well known in field of endeavor for a spring in this type of electric contact to be metal) in order to provide a known customizable electric connector that ensures good electric connection (see para. 127 and 144).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Ross, wherein the electrical connector defines a wired contact with the external fixation strut, a first pole being connected via an inner connector, a second pole being connected via an outer connector; and wherein the inner connector is a pogo-pin, and the outer connector is a metal spring, in view of Ferrante, in order to provide a known customizable electric connector that ensures good electric connection.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross (WO2009105479A1) in view of Pursley (US 4973331).
With respect to claims 6-8, Ross teaches an external fixation strut (e.g., 52, see fig. 3 above) comprising: an elongated body (e.g., between rings 56 and 54, see fig. 3 above) having a variable length (see para. 34 and note threaded telescopic rod attached to ring 56 is received within the rod attached to ring 54 as shown in fig. 3 above); at least a sensor (70) embedded into the elongated body (see fig. 6 above); and wherein it further comprises at least a wired data port (e.g., 58) which is engageable with a programmable wrench (10, see para. 55) meant to automatically adjust the length of the external fixation strut in order to transmit data about the variation in length of said elongated body to the programmable wrench (see para. 34).
Ross does not appear to teach the sensor able to detect at least a variation in length of the elongated body; and wherein the sensor is a position sensor which detects a position of a first shaft with respect to a second shaft of the elongated body, the first shaft and the second shaft being telescopically connected to define the elongated body.
Pursley, also drawn to external fixators, teaches a sensor (40) able to detect at least a variation in length of the elongated body of an external fixation strut (20) (see fig. 1a-1b) (see col. 2 lines 13-21 and col. 5 lines 1-4); and wherein the sensor is a position sensor which detects a position of a first shaft with respect to a second shaft of the elongated body (see col. 1 line 60- col. 2 line 2 and col. 5 lines 1-23), the first shaft and the second shaft being telescopically connected to define the elongated body (see col. 1 lines 21-23 and 44-49, e.g.- Ilizarov- type system) in order to provide a known means for sensing and providing feedback on the amount of adjustment of the length of the external fixation rod and representing the sensed amount of adjustment to a controller (see col. 5 lines 1-4 and 54-55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Ross to include a sensor able to detect at least a variation in length of the elongated body; and wherein the sensor is a position sensor which detects a position of a first shaft with respect to a second shaft of the elongated body, the first shaft and the second shaft being telescopically connected to define the elongated body, in view of Pursley, in order to provide a known means for sensing and providing feedback on the amount of adjustment of the length of the external fixation rod and representing the sensed amount of adjustment to a controller, as is well known in the art.
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross (WO2009105479A1) and Pursley (US 4973331), as applied to claim 8 above, in view of Heotis (US 20220071662).
As for claim 9, Ross, as modified by Pursley, does not appear to teach wherein the sensor is either an inductive or a capacitive sensor; and wherein the sensor detects the position of a metering cursor, which is integral to either the first shaft or the second shaft, along a sensing strip which is integral to the other between the first shaft or the second shaft.
Heotis, also drawn to surgical tools, teaches a variety of alternate equivalent position sensors (e.g., 1200, see fig. 12, para. 135) including inductive and capacitive sensor (see para. 135); and wherein the sensor detects the position of a metering cursor (note 1204, see fig. 12, para. 135-136), which is integral to either the first shaft or the second shaft, along a sensing strip which is integral to the other between the first shaft or the second shaft (see para. 135, fig. 12) in order to provide a known sensor configuration that accomplishes the desired function of position measurement (i.e.- measuring the change of length in the strut- see para. 135-136).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Ross, as modified by Pursley, wherein the sensor is either an inductive or a capacitive sensor, in view of Heotis, as a matter of engineering design choice, in order to provide a known sensor configuration that accomplishes the desired function of position measurement (i.e.- measuring the change of length in the strut).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ross (WO2009105479A1).
As for claim 15, Ross further teaches a port (58) connecting the programmable wrench to the external fixation strut (see fig. 3), the programmable wrench being able to univocally identify the external fixation strut to which the programmable wrench is connected via said port (see para. 29-34) but does not teach wherein said programmable wrench comprises a port for connection with an external fixation strut.
It would have been obvious to one of ordinary skill in the art the time the invention was made to modify Ross wherein the location of the port in Ross is reversed such that the programmable wrench comprises a port for connection with an external fixation strut, as set forth in claim 15, because the purpose of the port connection (providing coupling between the two electrically connected elements) would not be modified and the rearrangement of parts would simply be a matter of design choice. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: WO2018169547A1 (sensors); US 20170354439 (strut with programmable tools); US 20220354539 (strut with sensors); US 20160113681 (strut with programmable tools).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tara Carter whose telephone number is (571) 272-3402. The examiner can normally be reached on M-F 7am-3pm.
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/TARA ROSE E CARTER/ Examiner, Art Unit 3773
/EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773