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 .
Response to Arguments
Applicant’s amendments and arguments with respect to claim(s) 1, 3-10, 13-15, 17-24 and 26 have been fully considered and merit new grounds for rejection under 35 U.S.C. § 103 further in view of Wentorf (U.S. Patent Application Publication No. 2012/0022660).
Applicant’s remarks are confined to whether the combination of references of record as previously applied teach the amended claims, specifically with respect to the claimed alignment features. The remarks directed to Stein and Caylor are considered moot, as the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 23 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 23 does not appear to add additional limitations other than what is already claimed in claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, 8, 10, 22-23, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein et al. (U.S. Patent Application Publication No. 2013/0079675) hereinafter referred to as Stein; in view of Caylor et al. (U.S. Patent Application Publication No. 2012/0071735) hereinafter referred to as Caylor; in view of Wentorf (U.S. Patent Application Publication No. 2012/0022660) hereinafter referred to as Wentorf.
Regarding claim 1, Stein teaches an implantable medical device (Fig. 3, 200), comprising:
an implantable reporting processor (Fig. 3, element 100 insert) comprising:
a casing (Fig. 7, elements 102 and 104) having a first end (Fig. 7, support element 104), a second opposite the first end (Fig. 7, support element 102), and the casing separating an interior of the implantable reporting processor from an exterior of the implantable reporting processor (Figs. 3, 7, support structure forms a housing ¶[0032]); and
a sensor circuitry (¶[0076] sensors 602, interconnect 604, PCBs 622, circuitry 618, power source 616) comprising a printed circuit assembly (element 622, printed circuit boards, ¶[0076], Fig. 17) configured to fit within the interior of the implantable reporting processor (Fig. 17, these elements are within element 102/104, ¶[0032] and Fig. 7), and at least one sensing component associated with the printed circuit assembly (sensors 602, ¶[0076]) and configured to generate data in response to movement of the implantable medical device (¶[0075] magnitude and position of loading applied to a compartment of the knee); and
a battery coupled to the sensor circuitry and configured to fit within the interior of the implantable reporting processor (¶[0041] battery also in the support housing 102/104 along with the electronic circuitry, Fig. 7, element 616 power source);
a prosthesis configured to replace or supplement a body part (Fig. 3, tibial prosthetic component element 206) the prosthesis having a receptacle comprising a hollow portion (Fig. 7, element 206 has a hollow portion in element 504 open end/cavity) with a single open end (Fig. 17, open tray shape, see element 206 in Fig. 7, single open end of hollow portion element 504), wherein the receptacle of the prosthesis is configured to receive the first end of the casing such that the casing partially fits within the hollow portion of the receptacle (Fig. 17, element 104 bottom half of support structure housing fits within hollow portion element 506) and partially extends from the receptacle (Fig. 17, elements 102/104 support structure housing partially extends proud of receptacle element).
Stein does not teach a first affixing mechanism for the casing and a complementary affixing mechanism for the receptacle, and when the casing is fitted within the hollow portion of the receptacle then the battery is positioned at least partially within the receptacle of the prosthesis and when the casing is fitted within the hollow portion of the receptacle then the complementary affixing mechanism of the receptacle of the prosthesis is configured to engage with the affixing mechanism at the first end of the casing of the implantable reporting processor. Stein further does not teach an alignment mark and a complementary alignment mark to enable movement of the casing relative to the prosthesis to thereby enable an alignment of the alignment mark of the casing with the complementary alignment mark of the prosthesis.
Attention is drawn to the Caylor reference, which teaches a first affixing mechanism (Fig. 5A-D, threaded screw portion 112) for a casing (Fig. 5A-D, casing is considered to be taught by housing, element 108) and a complementary affixing mechanism (¶[0036] threaded aperture) for a receptacle (¶[0036] stem 104, Fig. 4), and when the casing is fitted within the hollow portion of the receptacle then the power supply is positioned at least partially within the receptacle of the prosthesis (¶¶[0043-0044]) and when the casing is fitted within the hollow portion of the receptacle then the complementary affixing mechanism of the receptacle of the prosthesis is configured to engage with the affixing mechanism at the first end of the casing of the implantable reporting processor (Fig. 4, ¶[0036]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the press-fit or interference fit of Stein between the casing and receptacle, to use an affixing mechanism and complementary affixing mechanism, as taught by Caylor, because Caylor teaches that affixing mechanisms and press-fitting, adhesives, and more securing means are all considered equivalents in the art (Caylor ¶¶[0036-0037]) and because “(i)t is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.” In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929).
Caylor also does not teach, specifically, a battery located in the casing that, when the casing is assembled into the receptacle, the battery is located at least partially in the receptacle, or an alignment mark and a complementary alignment mark to enable movement of the casing relative to the prosthesis to thereby enable an alignment of the alignment mark of the casing with the complementary alignment mark of the prosthesis.
It is noted that locating the electronic elements of the device, including sensors, a battery, and others, in any portion of the casing or receptacle, would not modify the operation of the device, and applicant has disclosed no criticality to their location within the casing.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the casing and receptacle arrangement of Stein to locate the electronic elements into any portion of the casing, in the receptacle, because Caylor specifically discloses that any location inside the tibial portion of a prosthesis is an appropriate location for the electronic elements of a sensing prosthesis (¶[0043] in the chamber, in the stem and/or platform) and because the courts have held that rearrangement of parts is an obvious matter of design choice (In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975), See MPEP § 2144).
Attention is brought to the Wentorf reference, which teaches a tibial prosthesis comprising an alignment mark and a complementary alignment mark (Fig. 4A-B, alignment indicia elements 70A and 70P) to enable movement of the casing relative to the prosthesis to thereby enable an alignment of the alignment mark of the casing with the complementary alignment mark of the prosthesis (Fig. 4A-B).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the prosthesis of Stein as modified to include alignment marks, as taught by Wentorf, to facilitate rotational alignment (Wentorf ¶[0133]).
Regarding claim 3, Stein as modified teaches the implantable medical device of claim 1.
Stein further teaches wherein the at least one sensing component is an accelerometer configured to generate data indicative of linear acceleration along a corresponding axis (¶[0060]).
Regarding claim 8, Stein as modified teaches the implantable medical device of claim 1.
Stein further teaches wherein the sensor circuitry further comprises at least one peripheral sensor configured to generate data, the at least one peripheral sensor corresponding to one of a pressure sensor and a temperature sensor (¶[0062] pressure and local temperature).
Regarding claim 10, Stein as modified teaches a method of monitoring movement of an implanted medical device in a patient, the method comprising:
generating data in response to movement of the implantable medical device of claim 1 (see rejection of claim 1) when the implantable medical device is implanted in the patient (as this is a method claim, the function following a contingent limitation “when” is not required); and analyzing the data to characterize a movement of the patient or to characterize a movement of the implanted medical device within the patient (¶[0027]).
Regarding claim 22, Stein as modified teaches the implantable medical device of claim 1.
Caylor further teaches wherein the affixing mechanism of the implantable reporting processor comprises one of threads (Fig. 5A-D, threaded screw portion 112).
Regarding claim 23, Stein as modified teaches the implantable medical device of claim 1.
Attention is brought to the Wentorf reference, which teaches a tibial prosthesis comprising an alignment mark and a complementary alignment mark (Fig. 4A-B, alignment indicia elements 70A and 70P) to enable movement of the casing relative to the prosthesis to thereby enable an alignment of the alignment mark of the casing with the complementary alignment mark of the prosthesis (Fig. 4A-B).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the prosthesis of Stein as modified to include alignment marks, as taught by Wentorf, to facilitate rotational alignment (Wentorf ¶[0133]).
Regarding claim 26, Stein as modified teaches the implantable medical device of claim 1.
Wentorf further teaches wherein the first end of the casing and the receptacle of the prosthesis have cylindrical characteristics (Fig. 4B, this comprises at least some characteristics of a cylinder as it comprises a radius of curvature and a height, Applicant has not claimed a strictly cylindrical shape) and the enabled movement comprises a rotational movement (¶[0133]).
Claim(s) 4-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein, Caylor, and Wentorf as applied to claim 1 above, and further in view of Donofrio et al. (U.S. Patent Application Publication No. 2007/0179739) hereinafter referred to as Donofrio.
Regarding claim 4, Stein as modified teaches the implantable medical device of claim 1.
Stein does not teach wherein the at least one sensing component is a gyroscope configured to generate data indicative of rotational acceleration about a corresponding axis.
Attention is brought to the Donofrio reference, which teaches at least one sensing component is a gyroscope configured to generate data indicative of rotational acceleration about a corresponding axis (¶[0043] gyroscope, rate of rotation in the inertial measurement unit).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the sensors of Stein as modified to include a gyroscope pedometer, as taught by Donofrio, to provide additional information about implant usage and provide sensing redundancy (Donofrio ¶[0088]) and to provide additional information for a clinician to review (Donofrio ¶[0089]).
Regarding claim 5, Stein as modified teaches the implantable medical device of claim 1.
Stein does not teach wherein the at least one sensing component is a pedometer configure to generate data indicative of a number of steps taken by a subject in which the implantable medical device is implanted.
Attention is brought to the Donofrio reference, which teaches at least one sensing component is a pedometer configure to generate data indicative of a number of steps taken by a subject in which the implantable medical device is implanted (¶[0043], ¶[0087] steps).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the sensors of Stein as modified to include a pedometer, as taught by Donofrio, to provide additional information about implant usage and provide sensing redundancy (Donofrio ¶[0088]) and to provide additional information for a clinician to review (Donofrio ¶[0089]).
Regarding claim 6, Stein as modified teaches the implantable medical device of claim 1.
Stein further teaches wherein the at least one sensing component is an accelerometer configured to generate data indicative of linear acceleration along a corresponding axis (¶[0060]).
Stein does not teach at least one gyroscope.
Attention is brought to the Donofrio reference, which teaches at least one sensing component is a gyroscope configured to generate data indicative of rotational acceleration about a corresponding axis (¶[0043] gyroscope, rate of rotation in the inertial measurement unit, ¶[0088]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the sensors of Stein as modified to include a gyroscope and accelerometer based pedometer, as taught by Donofrio, to provide additional information about implant usage and provide sensing redundancy (Donofrio ¶[0088]) and to provide additional information for a clinician to review (Donofrio ¶[0089]).
Regarding claim 7, Stein as modified teaches the implantable medical device of claim 1.
Stein does not teach wherein the at least one sensing component is an inertial measurement unit comprising: three accelerometers arranged relative to each other to sense and generate data indicative of linear acceleration along a respective corresponding axis; and three gyroscopes arranged relative to each other to sense and generate data indicative of rotational acceleration about a respective corresponding axis.
Attention is brought to the Donofrio reference, which teaches at least one sensing component is an inertial measurement unit comprising: three accelerometers arranged relative to each other to sense and generate data indicative of linear acceleration along a respective corresponding axis (¶[0089] three-axis accelerometer); and three gyroscopes arranged relative to each other to sense and generate data indicative of rotational acceleration about a respective corresponding axis (¶[0089] three-axis gyroscope).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the sensors of Stein as modified to include a gyroscope and accelerometer based pedometer, as taught by Donofrio, to provide additional information about implant usage and provide sensing redundancy (Donofrio ¶[0088]) and to provide additional information for a clinician to review (Donofrio ¶[0089]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein et al. (U.S. Patent Application Publication No. 2013/0079675) hereinafter referred to as Stein; in view of Caylor et al. (U.S. Patent Application Publication No. 2012/0071735) hereinafter referred to as Caylor; in view of Wasielewski et al. (U.S. Patent Application Publication No. 2015/0051455) hereinafter referred to as Wasielewski; in view of Wentorf (U.S. Patent Application Publication No. 2012/0022660) hereinafter referred to as Wentorf.
Regarding claim 9, Stein teaches an implantable medical device, comprising:
an implantable reporting processor (Fig. 3, element 100 insert) comprising:
a casing (Fig. 7, elements 102 and 104) having a first end (Fig. 7, support element 104), a second opposite the first end (Fig. 7, support element 102), and the casing separating an interior of the implantable reporting processor from an exterior of the implantable reporting processor (Figs. 3, 7, support structure forms a housing ¶[0032]); and
a sensor circuitry (¶[0076] sensors 602, interconnect 604, PCBs 622, circuitry 618, power source 616) comprising a printed circuit assembly (element 622, printed circuit boards, ¶[0076], Fig. 17) configured to fit within the interior of the implantable reporting processor (Fig. 17, these elements are within element 102/104, ¶[0032] and Fig. 7), and at least one sensing component associated with the printed circuit assembly (sensors 602, ¶[0076]) and configured to generate data in response to movement of the implantable medical device (¶[0075] magnitude and position of loading applied to a compartment of the knee);
communication circuitry configured to transmit data (¶[0076] short-range transmission of the measurement data) generated by the at least one sensing component (¶[0076] sensor data), the communication circuitry comprising a radio circuit associated with the printed circuit assembly and an antenna coupled to the radio circuit (¶[0076] antenna formed on PCB), and
a prosthesis configured to replace or supplement a body part (Fig. 3, tibial prosthetic component element 206) the prosthesis having a receptacle comprising a hollow portion (Fig. 7, element 206 has a hollow portion in element 504 open end/cavity) with a single open end (Fig. 17, open tray shape, see element 206 in Fig. 7, single open end of hollow portion element 504), wherein the receptacle of the prosthesis is configured to receive the first end of the casing such that the casing partially fits within the hollow portion of the receptacle (Fig. 17, element 104 bottom half of support structure housing fits within hollow portion element 506) and partially extends from the receptacle (Fig. 17, elements 102/104 support structure housing partially extends proud of receptacle element).
Stein does not teach a first affixing mechanism for the casing and a complementary affixing mechanism for the receptacle, and when the casing is fitted within the hollow portion of the receptacle then the battery is positioned at least partially within the receptacle of the prosthesis and when the casing is fitted within the hollow portion of the receptacle then the complementary affixing mechanism of the receptacle of the prosthesis is configured to engage with the affixing mechanism at the first end of the casing of the implantable reporting processor. Stein further does not teach an alignment mark and a complementary alignment mark to enable movement of the casing relative to the prosthesis to thereby enable an alignment of the alignment mark of the casing with the complementary alignment mark of the prosthesis.
Attention is drawn to the Caylor reference, which teaches a first affixing mechanism (Fig. 5A-D, threaded screw portion 112) for a casing (Fig. 5A-D, casing is considered to be taught by housing, element 108) and a complementary affixing mechanism (¶[0036] threaded aperture) for a receptacle (¶[0036] stem 104, Fig. 4), and when the casing is fitted within the hollow portion of the receptacle then the power supply is positioned at least partially within the receptacle of the prosthesis (¶¶[0043-0044]) and when the casing is fitted within the hollow portion of the receptacle then the complementary affixing mechanism of the receptacle of the prosthesis is configured to engage with the affixing mechanism at the first end of the casing of the implantable reporting processor (Fig. 4, ¶[0036]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the press-fit or interference fit of Stein between the casing and receptacle, to use an affixing mechanism and complementary affixing mechanism, as taught by Caylor, because Caylor teaches that affixing mechanisms and press-fitting, adhesives, and more securing means are all considered equivalents in the art (Caylor ¶¶[0036-0037]) and because “(i)t is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.” In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929).
Caylor also does not teach, specifically, a battery located in the casing that, when the casing is assembled into the receptacle, the battery is located at least partially in the receptacle.
It is noted that locating the electronic elements of the device, including sensors, a battery, and others, in any portion of the casing or receptacle, would not modify the operation of the device, and applicant has disclosed no criticality to their location within the casing.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the casing and receptacle arrangement of Stein to locate the electronic elements into any portion of the casing, in the receptacle, because Caylor specifically discloses that any location inside the tibial portion of a prosthesis is an appropriate location for the electronic elements of a sensing prosthesis (¶[0043] in the chamber, in the stem and/or platform) and because the courts have held that rearrangement of parts is an obvious matter of design choice (In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975), See MPEP § 2144).
Stein as modified does not teach that the antenna is elongated, and extending from the printed circuit assembly in a direction toward the second end of the casing, the elongated antenna comprising two substantially linear portions respectively coupled to the radio circuit and a curved portion between the linear portions or an alignment mark and a complementary alignment mark to enable movement of the casing relative to the prosthesis to thereby enable an alignment of the alignment mark of the casing with the complementary alignment mark of the prosthesis.
Attention is drawn to the Wasielewski reference, which teaches an elongated antenna (element 32, Figs. 3-4) extending from a printed circuit assembly (Figs. 3-4, elements 38 and 40 EMD and transmitter, ¶[0090])) in a direction toward an end of a casing, the elongated antenna comprising two substantially linear portions respectively coupled to the radio circuit and a curved portion between the linear portions (Figs. 3-4, element 32 is an elongated loop that has two linear portions and arcs between the linear portions), extending along a superior/inferior anatomical axis (Figs. 3-4, ¶[0089] upper vertical post comprises the antenna).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the implant device of Stein as modified to include an antenna as taught by Wasielewski, because Wasielewski states that the disclosed telemetry design is a “major advancement” for the orthopedic industry and specifically designed for use with a small rechargeable battery (Wasielewski ¶[0141] and ¶[0091]).
Stein as modified does not teach an alignment mark and a complementary alignment mark to enable movement of the casing relative to the prosthesis to thereby enable an alignment of the alignment mark of the casing with the complementary alignment mark of the prosthesis.
Attention is brought to the Wentorf reference, which teaches a tibial prosthesis comprising an alignment mark and a complementary alignment mark (Fig. 4A-B, alignment indicia elements 70A and 70P) to enable movement of the casing relative to the prosthesis to thereby enable an alignment of the alignment mark of the casing with the complementary alignment mark of the prosthesis (Fig. 4A-B).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the prosthesis of Stein as modified to include alignment marks, as taught by Wentorf, to facilitate rotational alignment (Wentorf ¶[0133]).
Claim(s) 13, 17-21, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein et al. (U.S. Patent Application Publication No. 2013/0079675) hereinafter referred to as Stein; in view of Caylor et al. (U.S. Patent Application Publication No. 2012/0071735) hereinafter referred to as Caylor; in view of Singh et al. (U.S. Patent Application Publication No. 2017/0056722) hereinafter referred to as Singh; in view of Wentorf (U.S. Patent Application Publication No. 2012/0022660) hereinafter referred to as Wentorf.
Regarding claims 13 and 24, Stein teaches an implantable medical device (Abstract, Fig. 2), comprising:
an implantable reporting processor (Fig. 3, element 100 insert) comprising:
a casing (Fig. 7, elements 102 and 104) having a first end (Fig. 7, support element 104), a second opposite the first end (Fig. 7, support element 102), and the casing separating an interior of the implantable reporting processor from an exterior of the implantable reporting processor (Figs. 3, 7, support structure forms a housing ¶[0032]); and
a sensor circuitry (¶[0076] sensors 602, interconnect 604, PCBs 622, circuitry 618, power source 616) comprising a printed circuit assembly (element 622, printed circuit boards, ¶[0076], Fig. 17) configured to fit within the interior of the implantable reporting processor (Fig. 17, these elements are within element 102/104, ¶[0032] and Fig. 7), and at least one sensing component associated with the printed circuit assembly (sensors 602, ¶[0076]) and configured to generate data in response to movement of the implantable medical device (¶[0075] magnitude and position of loading applied to a compartment of the knee); and
a battery coupled to the sensor circuitry and configured to fit within the interior of the implantable reporting processor (¶[0041] battery also in the support housing 102/104 along with the electronic circuitry, Fig. 7, element 616 power source);
a prosthesis configured to replace or supplement a body part (Fig. 3, tibial prosthetic component element 206) the prosthesis having a receptacle comprising a hollow portion (Fig. 7, element 206 has a hollow portion in element 504 open end/cavity) with a single open end (Fig. 17, open tray shape, see element 206 in Fig. 7, single open end of hollow portion element 504), wherein the receptacle of the prosthesis is configured to receive the first end of the casing such that the casing partially fits within the hollow portion of the receptacle (Fig. 17, element 104 bottom half of support structure housing fits within hollow portion element 506) and partially extends from the receptacle (Fig. 17, elements 102/104 support structure housing partially extends proud of receptacle element).
Stein does not teach a first affixing mechanism for the casing and a complementary affixing mechanism for the receptacle, and when the casing is fitted within the hollow portion of the receptacle then the battery is positioned at least partially within the receptacle of the prosthesis and when the casing is fitted within the hollow portion of the receptacle then the complementary affixing mechanism of the receptacle of the prosthesis is configured to engage with the affixing mechanism at the first end of the casing of the implantable reporting processor. Stein further does not teach an alignment mark and a complementary alignment mark to enable movement of the casing relative to the prosthesis to thereby enable an alignment of the alignment mark of the casing with the complementary alignment mark of the prosthesis.
Attention is drawn to the Caylor reference, which teaches a first affixing mechanism (Fig. 5A-D, threaded screw portion 112) for a casing (Fig. 5A-D, casing is considered to be taught by housing, element 108) and a complementary affixing mechanism (¶[0036] threaded aperture) for a receptacle (¶[0036] stem 104, Fig. 4), and when the casing is fitted within the hollow portion of the receptacle then the power supply is positioned at least partially within the receptacle of the prosthesis (¶¶[0043-0044]) and when the casing is fitted within the hollow portion of the receptacle then the complementary affixing mechanism of the receptacle of the prosthesis is configured to engage with the affixing mechanism at the first end of the casing of the implantable reporting processor (Fig. 4, ¶[0036]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the press-fit or interference fit of Stein between the casing and receptacle, to use an affixing mechanism and complementary affixing mechanism, as taught by Caylor, because Caylor teaches that affixing mechanisms and press-fitting, adhesives, and more securing means are all considered equivalents in the art (Caylor ¶¶[0036-0037]) and because “(i)t is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.” In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929).
Caylor also does not teach, specifically, a battery located in the casing that, when the casing is assembled into the receptacle, the battery is located at least partially in the receptacle.
It is noted that locating the electronic elements of the device, including sensors, a battery, and others, in any portion of the casing or receptacle, would not modify the operation of the device, and applicant has disclosed no criticality to their location within the casing.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the casing and receptacle arrangement of Stein to locate the electronic elements into any portion of the casing, in the receptacle, because Caylor specifically discloses that any location inside the tibial portion of a prosthesis is an appropriate location for the electronic elements of a sensing prosthesis (¶[0043] in the chamber, in the stem and/or platform) and because the courts have held that rearrangement of parts is an obvious matter of design choice (In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975), See MPEP § 2144).
Stein as modified does not teach wherein the processor transitions operation of the sensor circuitry between a low power mode in which a first set of sensors of the plurality of sensors is active to generate data at a first sampling rate, which data is indicative of linear acceleration, and a high power mode in which a second set of the plurality of sensors that includes the first set of sensors and at least one additional sensor is active to generate data at a second sampling rate greater than the first sampling rate, which data is indicative of linear acceleration and rotational acceleration.
It is noted that each of these modes does not comprise a mutually exclusive activation of sensors. Instead, the low power mode can comprise a plurality of active sensors as long as it is also active to generate data indicative of linear acceleration. Neither of the low or high power modes require that any of the sensors are inactive upon transition to said low or high power modes.
Attention is brought to the Singh reference, which teaches wherein a processor transitions operation of a sensor circuitry (Abstract, ¶[0017] computing device, sensor circuitry) between a low power mode in which a first set of sensors of a plurality of sensors is active to generate data at a first sampling rate (Fig. 3, Normal State, ¶[0038] the normal state set of sensor components includes an accelerometer, ¶[0037] sampling rate is a first, normal rate), which data is indicative of linear acceleration (¶[0038] accelerometer), and a high power mode in which a second set of the plurality of sensors that includes the first set of sensors and at least one additional sensor (Fig. 3, Upsampling State, ¶[0042] greater number of sensor components, include all sensor components) is active to generate data at a second sampling rate greater than the first sampling rate (¶[0038] Normal State includes fewer sensor components than the Upsampling State and lower sampling rate than the Upsampling state), which data is indicative of linear acceleration and rotational acceleration (¶[0017] all of the activity recognition sensors include both accelerometers and gyroscopes).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the implant processor of Stein as modified to include sensor resolution and upsampling management, as taught by Singh, because Singh teaches that upsampling reduces false positives and/or allows for recognizing user activity at a higher accuracy and with a lower latency (Singh, ¶[0102]).
Stein as modified does not teach an alignment mark and a complementary alignment mark to enable movement of the casing relative to the prosthesis to thereby enable an alignment of the alignment mark of the casing with the complementary alignment mark of the prosthesis.
Attention is brought to the Wentorf reference, which teaches a tibial prosthesis comprising an alignment mark and a complementary alignment mark (Fig. 4A-B, alignment indicia elements 70A and 70P) to enable movement of the casing relative to the prosthesis to thereby enable an alignment of the alignment mark of the casing with the complementary alignment mark of the prosthesis (Fig. 4A-B).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the prosthesis of Stein as modified to include alignment marks, as taught by Wentorf, to facilitate rotational alignment (Wentorf ¶[0133]).
Regarding claim 17, Stein as modified teaches the implantable medical device of claim 13.
Stein as modified does not teach wherein, in the low power mode the sensing sensor circuitry generates data at a first resolution, and in the high power mode the sensing sensor circuitry generates data at a second resolution higher than the first resolution.
Attention is brought to the Singh reference, which teaches wherein, in the low power mode the sensing sensor circuitry generates data at a first resolution (Fig. 3, Normal State, ¶[0038] the normal state set of sensor components includes an accelerometer, ¶[0037] sampling rate is a first, normal rate resulting in a first, normal temporal resolution for sensor data), and in the high power mode (Fig. 3, Upsampling state) the sensing sensor circuitry generates data at a second resolution higher than the first resolution (¶[0038] Normal State includes fewer sensor components than the Upsampling State and lower sampling rate than the Upsampling state).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the implant processor of Stein as modified to include sensor resolution and upsampling management, as taught by Singh, because Singh teaches that upsampling reduces false positives and/or allows for recognizing user activity at a higher accuracy and with a lower latency (Singh, ¶[0102]).
Regarding claim 18, Stein as modified teaches the implantable medical device of claim 13.
Stein as modified does not teach wherein the processing circuitry is configured to transition the sensing sensor circuitry from low power mode to high power mode upon detection of a first trigger event.
Attention is brought to the Singh reference, which teaches wherein the processing circuitry is configured to transition the sensing sensor circuitry from low power mode to high power mode upon detection of a first trigger event (¶[0078] trigger a state transition to an Upsampling state based on activity detection).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the implant processor of Stein as modified to include sensor resolution and upsampling management, as taught by Singh, because Singh teaches that upsampling reduces false positives and/or allows for recognizing user activity at a higher accuracy and with a lower latency (Singh, ¶[0102]).
Regarding claim 19, Stein as modified teaches the implantable medical device of claim 18.
Stein as modified does not teach wherein the first trigger event corresponds to a number of steps by a person in which the implantable medical device is implanted.
Attention is brought to the Singh reference, which teaches the first trigger event corresponds to a number of steps by a person (¶[0023] the trigger event is a fitness activity, which includes walking and running, ¶[0027]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the implant processor of Stein as modified to include sensor resolution and upsampling management, as taught by Singh, because Singh teaches that upsampling reduces false positives and/or allows for recognizing user activity at a higher accuracy and with a lower latency (Singh, ¶[0102]).
Regarding claim 20, Stein as modified teaches the implantable medical device of claim 18.
Stein as modified does not teach wherein the processing circuitry is configured to transition the sensing sensor circuitry from high power mode to low power mode upon occurrence of a second trigger event.
Attention is brought to the Singh reference, which teaches wherein the processing circuitry is configured to transition the sensing sensor circuitry from high power mode to low power mode upon occurrence of a second trigger event (Fig. 3, step 318, ¶[0082] state transition from Upsampling state back to Normal state; step 320 Inactive also returns the state machine to Normal state).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the implant processor of Stein to include sensor resolution and upsampling management, as taught by Singh, because Singh teaches that upsampling reduces false positives and/or allows for recognizing user activity at a higher accuracy and with a lower latency (Singh, ¶[0102]).
Regarding claim 21, Stein as modified teaches the implantable medical device of claim 20.
Stein as modified does not teach wherein the second trigger event corresponds to either of a minimum number of steps by a person in which the implantable medical device is implanted, and a time lapse prior to the person taking the minimum number of steps.
Attention is brought to the Singh reference, which teaches wherein the second trigger event corresponds to either of a minimum number of steps by a person in which the implantable medical device is implanted, and a time lapse prior to the person taking the minimum number of steps (¶[0088] the user has been inactive for a defined period of time, return to Normal state in Fig. 3 in step 320)
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the implant processor of Stein as modified to include sensor resolution and upsampling management, as taught by Singh, because Singh teaches that upsampling reduces false positives and/or allows for recognizing user activity at a higher accuracy and with a lower latency (Singh, ¶[0102]).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stein, Caylor, Singh, and Wentorf as applied to claim 13 above, and further in view of Donofrio et al. (U.S. Patent Application Publication No. 2007/0179739, previously cited) hereinafter referred to as Donofrio.
Regarding claims 14-15, Stein as modified teaches the implantable medical device of claim 13.
Stein as modified does not teach wherein: the plurality of sensors comprises at least three accelerometers arranged relative to each other to sense and generate data indicative of linear acceleration along a respective corresponding axis.
Attention is brought to the Donofrio reference, which teaches at least one sensing component is an inertial measurement unit comprising: three accelerometers arranged relative to each other to sense and generate data indicative of linear acceleration along a respective corresponding axis (¶[0089] three-axis accelerometer); and three gyroscopes arranged relative to each other to sense and generate data indicative of rotational acceleration about a respective corresponding axis (¶[0089] three-axis gyroscope).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the sensors of Stein as modified to include a gyroscope and accelerometer based pedometer, as taught by Donofrio, to provide additional information about implant usage and provide sensing redundancy (Donofrio ¶[0088]) and to provide additional information for a clinician to review (Donofrio ¶[0089]).
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.
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792
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