DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed February 12th, 2026 have been fully considered but they are not persuasive.
Applicant argues that the proposed modification of DiSilvestro et al. in view of McCarthy Soubeiran. Specifically, Applicant argues “the bong elongation device can be activated and then a pre-programmed program is started which performed incremental changes in the device” is not performed by the device of McCarthy. The Examiner respectfully disagrees with this assertion. As outlined in ¶54 of McCarthy, “the motor can be controlled with a pre-programmed microchip that is implanted with the device 92. The microchip may instruct the motor to perform lengthening steps as described above in terms of degree of movement of one plate relative to the other (e.g., {fraction (1/100)} mm per time, one hundred times per day, {fraction (1/10)} mm per time, ten times per day, or 1/4 mm per time, four times per day). The microchip may instruct the motor to run for set durations (e.g., on for 10 seconds, off for 50 minutes), where the time the motor runs is correlatable with the degree of movement of one plate relative to the other.” Therefore, the pre-programmed microchip which is the controller, is activated after implantation (see ¶53 and ¶54) and the pre-programmed program is started which preforms the incremental changes in the device (¶54) and therefore is anticipated by McCarthy as set forth in the previous rejections of claim 148 throughout prosecution.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claim 147, 149, 151-154 and 156-163 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over DiSilvestro et al. (US 2006/0069447) in view of McCarthy (US 2005/0234448) in view of Soubeiran (US 2010/0049204).
Regarding claim 147, DiSilvestro et al. disclose an implantable device for the elongation of a bone in a mammal, comprising at least one elongated device (22) adapted to be implanted in relation to said bone, two or more anchoring devices (24 + 26) adapted to be in contact with the bone in said mammal (figures 7 and 8), adapted to engage the bone and stabilizing in relation to the bone, wherein said anchoring devices are adapted to be implanted intramedullary in the bone of said mammal, wherein the two or more anchoring devices are adapted to engage said bone from the inside of the intramedullary cavity of the hone and carry weight on the inside of the bone (this is accomplished when the device is used in conjunction with the patient’s natural femoral head and neck), and an adjustment device (154 + 156) adapted to be implanted intramedullary in the bone of said mammal (figures 7 and 8), for adjusting at least one mechanical bone related parameter of said at least one elongated device (¶40, ¶52 and ¶62), wherein said adjustment device is constructed to postoperatively non-invasivelv adjust said at least one mechanical bone related parameter (¶40, ¶52 and ¶62), and wherein said adjustment device is adapted to at least adjust the distance between or orientation of the at least two anchoring devices, wherein the adjustment device further comprising a control device (100), and wherein the adjustment device is configured to be controlled by said control device (¶40, ¶44, ¶51-54, ¶56), wherein the control device is configured to be programmed to regular the apparatus according to input from a sensor sensing any possible physical parameter of the patient or any functional parameter of the system (¶67, via regulation of the subsidence of the implant into the femur), and wherein the elongated device is sized and adapted to be placed in a central portion of a medullar cavity in the bone (figures 1-3, column 2, line 41 – column 3, line 3) so that a first end (see figure below) of the elongated device is arranged at a distance from a proximal portion of the bone (the region of initial insertion into the medullar cavity closest to the pelvis) and that a second opposite end of the elongated device (see figure below) is arranged so that none of it extends out of the medullar cavity (the end inserted deepest into the medullar cavity of the bone closest to the knee joint).
However, DiSilvestro et al. fail to teach that the control device is configured to be at least one of; programmable from outside the patient’s body, programmed to regulate the apparatus according to a pre-programmed time-schedule, and programmed to regulate the apparatus according to input from a sensor sensing any possible physical parameter of the patient or any functional parameter of the system. Additionally, DiSilvestro et al. fails to expressly teach the control device follows a program of incremental changes, communicated to the control device alter implantation and or during the treatment (¶53-54 of McCarthy).
McCarthy teaches an implantable device for the adjustment of a bone in a mammal (figures 1-6B) the device includes an implantable internal control unit (¶53) that is adapted to directly control and regulate the implantable device according to a pre-programmed time-schedule (¶53-54) of incremental changes (¶53-54), communicated to the control device after implantation (¶54) or during treatment (¶53-54) to permit displacement of the bone to take place evenly throughout a range and at a specific rate of translation per day. Such that lengthening can occur continuously throughout all or part of each day, in a single step, or may be accomplished in a series of discrete lengthening steps thereby providing the patient with a more custom manner of treatment ¶53-54).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of invention to have constructed the implantable internal control unit to be pre-programmed according to a time schedule as taught by McCarthy to permit displacement of the bone to take place evenly throughout a range and at a specific rate of translation per day. Such that lengthening can occur continuously throughout all or part of each day, in a single step, or may be accomplished in a series of discrete lengthening steps thereby providing the patient with a more custom manner of treatment.
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With respect to claim 147, DiSilvestro et al. teach “the concepts of the present disclosure may also be used in the construction of fracture management devices thereby providing the device with the ability to compress a fracture site through external fixators, nails, and/or plates. The concepts of the present disclosure may also be used in the construction of expandable and contractible nails for use in, amongst other things, trauma procedures”, see ¶65. However, DiSilvestro et al. fail to expressly teach or disclose nail or fracture site stabilization device is adapted to be placed in a central portion of a medullary canal such that two ends opposite to one another do not extend out of the medullar cavity. Soubeiran discloses an adjustable implantable device (figures 7-12) which can be used in either prosthetic or intramedullary nail applications (Abstract, ¶2, ¶33, ¶64, ¶89). The implantable device adapted to be placed in a central portion of a medullar cavity in the bone (“intramedullary nail” Abstract, ¶2, ¶89) has a first end (@11, figures 7-8) and a second end (@35, figures 7-8) opposite the first in which neither end extends out of the medullar cavity (Abstract, ¶2, ¶33, ¶89) as the device is an intramedullary nail which is implanted in the medullary canal of the long bone (¶33). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of invention to modified the device of DiSilvestro et al. to be an intramedullary nail as DiSilvestro et al. teaches their invention can be adapted for us in a fracture fixation and contractible nails (¶65) in which the first and second ends of the intramedullary nail do not extend out of the medullar cavity as taught by Soubeiran as intramedullary nails for lengthening bones are disposed entirely in the medullar cavity due to their intramedullary nature. Additionally, Silvestro et al. fail to expressly teach or disclose at least one of the anchoring devices comprises an expandable part configured to expand at least partially perpendicular to the longitudinal extension of the elongated device.
Regarding claim 149, DiSilvestro et al. disclose that the adjustment is at least one of the lengthening of a bone, the compression of a bone, the healing of a fracture, the changing of a hone angle, the reshaping of a bone, a step in a treatment to correct a limb discrepancy caused by at least one of; a congenital condition, deformation or previous trauma, changing the curvature of a bone, changing the torsion of a bone, changing the angle between the diaphysis and the epiphysis, changing the thickness of a bone, changing the curvature of the spine, adjoining of vertebrae adapted to change at least one of; the curvature of the spine and to relieve a herniated lumbar disc or the like (¶19-21, ¶26 and ¶35 of DiSilvestro/ ¶53-54 of McCarthy). Regarding claim 151, DiSilvestro et al. disclose that the force exerted by the adjustment device is, at least one of; a longitudinal force, extending the length of the bone, directed to the end portions of tire medullar cavity, a longitudinal force, adjusting the angle or curvature of the hone, and applying torque to the bone, adjusting the torsion of the bone along it’s longitudinal axis (¶57-64). Regarding claim 152, DiSilvestro et al. disclose that the adjustment device is, at least one of adapted to comprise torsion of a bone, adapted to change the angle of a bone, adapted to have at least, two parts to rotate in relation to each other, wherein the adjustment device comprises at least two parts, adapted to have at least two parts to rotate in relation to each other, wherein said adjustment device comprises at least two parts, the relative rotation being anchored by at least two anchoring' devices, adapted to have at least two parts angled in relation to each other, wherein the adjustment device comprises at least two parts, adapted to change the curvature of a bone, adapted to change the curvature of the spine, adapted to adjoining vertebrae, adapted to change at least one of; the curvature of the spine and to relieve a herniated lumbar disc or the like, or adapted to non-adjoining vertebrae (figures 7 and 8, ¶57-65) . Regarding claim 153, DiSilvestro et al. disclose that the control device, at least one of controls incremental changes of the adjustment device, communicated to the receiver after implantation and/or during the treatment by using an comprised external control unit and an implantable receiver suitable for wireless communication with said external control unit, having a transmitter located outside the body, regulates the device non-invasively by manually pressing at least one subcutaneous switch, whereby the operation of the device is switched on and off, further comprising an implantable internal energy source for powering implantable energy consuming components of the apparatus, and regulates the device non-invasively by manually pressing at least one subcutaneous switch, wherein the switch sends information to the internal control unit to perform a certain predetermined performance (¶40, ¶44, ¶51-54 and ¶56). Regarding claim 154, DiSilvestro et al. disclose that the adjustment device comprises at least one of a mechanical device (154 + 156) for said bone adjustment, a mechanical device for said hone adjustment comprising at least one nut and screw, a mechanical device for said bone adjustment comprising at least one gearbox, a mechanical device for said hone adjustment comprises a servo mechanism, or mechanical amplifier, and at least one of; a hydraulic and mechanical device for said hone adjustment, which comprising a mechanical multi step locking mechanism, locking the mechanical device in its new position alter adjustment, and at least one of; a mechanical and hydraulic device for said bone adjustment, which comprising a mechanical multi step locking mechanism, locking the mechanical device in its new position after adjustment, comprising at least one of; a sprint, an elongated structure using the principle of saw teeth, flanges, barbs or a bonnet band, a nut, a gearbox, or a spring loaded locking principle (¶58). Regarding claim 156, DiSilvestro discloses that the adjustment device is at least one of flexible to allow introduction into the medullar cavity, at least partly elastic and is flexible to allow introduction into the medullar cavity, comprising a spring and is flexible to allow introduction into the medullar cavity, adapted to regain its shape after having been bent, adapted for exerting an intermittent and/or oscillating force, and comprising a locking device, which allows extension of the device but substantially prevents contraction, comprising a sensor (108, figures 7 and 8) direct or indirect sensing the position of the adjustment device (¶40, ¶52 and ¶54). Regarding claim 157, DiSilvestro et al. disclose that the device comprises a sensor (108) directly or indirectly sensing the position of the adjustment device, the device comprises a feedback transmitter adapted to transmit information, received direct or indirect from said sensor out from the human body, said transmitted information being adapted to be received by an external control unit (104) and relating to the position of the adjustment device (¶40, ¶52 and ¶54). Regarding claim 158, DiSilvestro et al. disclose the device further comprises at least one of a sensor or measuring device sensing or measuring a functional parameter correlated to the transfer of energy for charging an internal energy source, and a feedback device for sending feedback information from inside the patient’s body to the outside thereof, the feedback information being related to the functional parameter sensed by the sensor or measured by the measuring device, further comprising an implantable internal energy source for powering implantable energy consuming components of the apparatus, arid an external energy source for transferring energy in a wireless mode, wherein the internal energy source is chargeable by the energy transferred in the wireless mode, a feedback device for sending feedback information from inside the patient's body to the outside thereof, the feedback information being related to at least cure of a physical parameter of the patient and a functional parameter related to the apparatus, a sensor and/or a measuring device and an implantable internal control unit for controlling the apparatus in response to information being related to at least one of a physical parameter of the patient sensed by the sensor or measured by the measuring device and a functional parameter related to the apparatus sensed by the sensor or measured by the measuring device, or an external data communicator and an implantable internal data communicator communicating with the external data communicator, wherein the internal communicator feeds data related to the apparatus or the patient to the external data communicator and/or the external data communicator feeds data to the internal data communicator (140, 152 + 156). Regarding claim 159, DiSilvestro discloses the system including at least one switch implantable in the patient for manually and non-invasively controlling the device, a wireless remote control for non-invasively controlling the apparatus, and a hydraulic device having an implantable hydraulic reservoir, which is hydraulically connected to the apparatus, wherein the apparatus is adapted to be non-invasively regulated by manually pressing the hydraulic reservoir (104, figures 7-8). Regarding claim 160, DiSilvestro disclose the system including at least one of a wireless energy-transmission device for non-invasively energizing implantable energy consuming components of the apparatus with wireless energy, an implantable internal energy source for powering implantable energy consuming components of the apparatus, and an external energy source for transferring energy in a wireless mode and an implantable internal energy source for powering implantable energy consuming components of the apparatus, wherein the internal energy source is chargeable by the energy transferred in the wireless mode, implantable electrical components including at least one voltage level guard and/or at least one constant current guard, an energy-transforming device for transforming the wireless energy transmitted by the energy-transmission device from a first form into a second form of energy, wherein the second form energy is used at least partly to charge an accumulator (¶40 and ¶52-64). Regarding claim 161, DiSilvestro disclose the system includes at least one of an operation device for operating the apparatus, wherein the wireless energy is used in its wireless state to directly power the operation device to create kinetic energy for the operation of the apparatus, as the wireless energy is being transmitted by the energy-transmission device, or an energy-transforming device for transforming the wireless energy transmitted by the energy-transmission device from a first form into a second form of energy, wherein the energy-transforming device directly powers implantable energy consuming components of the apparatus with the second form energy, as the energy-transforming device transforms the first form energy transmitted by the energy-transmission device into the second form energy (¶40 and ¶52-64). Regarding claim 162, DiSilvestro disclose the system including a wireless energy-transmission device for non-invasively energizing implantable energy consuming components of the apparatus with wireless energy, further comprising a control device for controlling the transmission of wireless energy from the energy-transmission device, and an implantable internal energy receiver for receiving the transmitted wireless energy, the internal energy receiver being connected to implantable energy consuming components of the apparatus for directly or indirectly supplying received energy thereto, the system further comprising a determination device adapted to determine an energy balance between the energy received by the internal energy receiver and the energy used for the implantable energy consuming components of the apparatus, wherein the control device controls the transmission of wireless energy from the external energy-transmission device, based on the energy balance determined by the determination device (¶40 and ¶52-64). Regarding claim 163, DiSilvestro discloses the system including a feedback device for sending feedback information from inside the patient’s body to the outside thereof, the feedback information being related to at least one of a physical parameter of the patient and a functional parameter related to the apparatus, and an implantable internal energy receiver for receiving wireless energy, the energy receiver having an internal first coil and a first electronic circuit connected to the first coil, and an external energy transmitter for transmitting wireless energy, the energy transmitter having an external second coil and a second electronic circuit connected to the second coil, wherein the external second coil of the energy transmitter transmits wireless energy which is received by the first coil of the energy receiver, the system further comprising a feedback device for communicating out the amount of energy received in the first coil as a feedback information, and wherein the second electronic circuit includes a determination device for receiving the feedback information and for comparing the amount of transferred energy by the second coil with the feedback information related to the amount of energy received in the first coil to obtain the coupling factors between the first and second coils, wherein said implantable device for the adjustment of a bone is adapted to be wirelessly powered, directly or indirectly, and adapted to receive wireless energy, non-invasively transmitted from an external source for adjusting said at least one mechanical bone related parameter by said adjustment device, wherein the implantable device further comprising a feedback device for sending feedback information from inside the patient’s body to the outside thereof, the feedback information being related to at least one of a physical parameter of the patient and a functional parameter related to the implantable device, wherein the feedback information comprises at least information relating to an amount of energy received in a first coil, when and during the wireless energy being received, and wherein the two or more anchoring devices are adapted to securely engage the surrounding bone from inside the medullar cavity, and comprise a part securing and extending at least partially perpendicular to the longitudinal extension of the elongated device for engaging and stabilizing the anchoring device in relation to the bone (¶40 and ¶52-64).
Claim 155 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over DiSilvestro et al. (US 2006/0069447) in view of McCarthy (US 2005/0234448) and Soubeiran (US 2010/0049204) in further view of Magill et al. (US 2009/0088766). Regarding claim 155, DiSilvestro et al. in view of McCarthy disclose the claimed invention except for the adjustment device is a hydraulic device for the bone adjustment. The hydraulic device comprises a cylinder and a piston.
Magill et al. disclose a bone adjustment device (figures 6A and 6B) which comprises a hydraulic device (¶8, ¶32 and ¶37) which comprises a cylinder (323 + 324, figures 6A and 6B) and a piston (322, figures 6A and 6B) as it is a known alternative mechanism for adjusting the spacing of bones/bone fragments (¶8, ¶32 and ¶37). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the adjustment device of DiSilvestro in view of McCarthy to be a hydraulic device comprising a cylinder and piston as taught by Magill et al. as it is a known alternative mechanism for adjusting the spacing of bones/bone fragments and would predictably yield a device capable of adjusting the spacing between the two bones/bone fragments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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