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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-15 and 36-46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stein (U.S. 2016/0089079). Stein discloses a sensor device for an implantable medical device (Abstract; “The orthopedic implant can include electronic circuitry, a power source, and one or more sensors for measuring a parameter of the muscular-skeletal system or a parameter of in proximity to the implant”), the sensor device comprising: a housing (par. 0225; “Electronic circuitry 3110 can be fitted in the cavity formed by housing 3122 of structure 3102. In one embodiment, the cavity is formed in an unloaded or lightly loaded area of prosthetic component 3100”), wherein the housing includes a diaphragm portion (par. 0224); a sensor measurement component positioned within the housing and at least partially aligned with the diaphragm portion (element 3106, 3120; par. 0225; “Interconnect 3106 and the sensors therein couple to electronic circuitry 3110. Interconnect 3106 include interconnect that couples the sensors to electronic circuitry 3110”), wherein, when the medical device is implanted within a patient (par. 0074; “sensor 100 can be used for other joint surgeries; it is not limited to knee replacement implant or implants”), the sensor measurement component is configured to measure one or more physiological parameters of the patient (par. 0216; “Measuring an elapsed time of a large number of measurement cycles can be used to generate an average time period of a measurement cycle when change in the parameter being measured occurs slowly in relation to physiological changes such as occurs in the muscular-skeletal system”); and a coupling element positioned between the diaphragm portion and the sensor measurement component and at least partially covering or encapsulating the sensor measurement component (Fig. 31; “element 3112, 3114; par. 0227; The force, pressure, or load applied to articular surface 3118 and 3120 is respectively transferred to surface 3112 and 3114 of structure 3102. It should be noted that surface 3112 and surface 3114 are compliant and not rigid. Each surface has sufficient compliance that allows the underlying sensors to compress. In one embodiment, surface 3112 and surface 3114 is thinned or made thin to achieve compliance”), wherein the coupling element is composed of a solid elastomeric material (par. 0224 and 0227; “Alternatively, support structures 3112 and 3114 can comprise a material that is compliant such as a polymer material”).
Regarding claim 2, Stein discloses (Abstract) the diaphragm portion is configured to transmit the one or more physiological parameters to the measurement component (“one or more sensors for measuring a parameter of the muscular-skeletal system”).
Regarding claim 3, Stein discloses (Fig. 31) the coupling element has an end portion, and wherein the diaphragm portion at least partially contacts the end portion.
Regarding claim 4, Stein discloses (Fig. 31) the diaphragm portion has a first geometry and the end portion has a second geometry, and wherein the first geometry corresponds with the second geometry.
Regarding claim 5, Stein discloses (Fig. 31) the diaphragm portion has a first thickness and a portion of the housing surrounding the diaphragm portion has a second thickness greater than the first thickness.
Regarding claim 6, Stein discloses (par. 0224) at least a portion of a surface area of the housing further includes a pressure-responsive complex, and wherein the pressure- responsive complex includes the diaphragm portion.
Regarding claim 7, Stein discloses (par. 0224) the pressure-responsive complex further includes one or more pressure-sensitive regions.
Regarding claim 8, Stein discloses (Fig. 31) the pressure-responsive complex extends at least partially along an axis parallel to a longitudinal axis of the housing.
Regarding claim 9, Stein discloses (Fig. 31) the pressure-responsive complex extends at least partially radially around the housing in a direction approximately perpendicular to a longitudinal axis of the housing.
Regarding claim 10, Stein discloses (Fig. 31 surface area of 3120) the pressure-responsive complex includes at least 5% of a surface area of the housing.
Regarding claim 11, Stein discloses (Fig. 31 surface area of 3120) the pressure-responsive complex includes at least 50% of a surface area of the housing.
Regarding claim 12, Stein discloses (Fig. 31) the pressure-responsive complex has a same thickness as the housing.
Regarding claim 13, Stein discloses (par. 0226) a barrier component (hermetic or other seal) proximate to the pressure responsive complex, and wherein the barrier component is configured to at inhibit or otherwise limit host tissue from forming tissues bridges with at least a portion of the pressure-responsive complex.
Regarding claim 14, Stein discloses (Fig. 31) the barrier component is positioned to function as a strain relief mechanism that at least partially limits transmittal of forces from native tissues to at least a portion of the pressure-responsive complex.
Regarding claim 15, Stein discloses (Fig. 31) the barrier component defines an outer perimeter or boundary that at least partially surrounds the pressure-responsive complex.
Regarding claim 36, Stein discloses a sensor device for an implantable medical device (Abstract; “The orthopedic implant can include electronic circuitry, a power source, and one or more sensors for measuring a parameter of the muscular-skeletal system or a parameter of in proximity to the implant”), the sensor device comprising: a housing (par. 0225; “Electronic circuitry 3110 can be fitted in the cavity formed by housing 3122 of structure 3102. In one embodiment, the cavity is formed in an unloaded or lightly loaded area of prosthetic component 3100”), wherein the housing includes a pressure-responsive complex portion (par. 0221; “A force, pressure, or load applied to articular surfaces 3118 and 3120 apply a corresponding force, pressure, or load to support surfaces 3112 and 3114”), and wherein the pressure-responsive complex portion includes at least 5% of a surface area of the housing (Fig. 31 surface area of 3120); a sensor measurement component positioned within the housing and aligned with the pressure-responsive complex portion (element 3106, 3120; par. 0225; “Interconnect 3106 and the sensors therein couple to electronic circuitry 3110. Interconnect 3106 include interconnect that couples the sensors to electronic circuitry 3110”), wherein, when the medical device is implanted within a patient (par. 0074; “sensor 100 can be used for other joint surgeries; it is not limited to knee replacement implant or implants”), the sensor measurement component is configured to measure one or more physiological parameters of the patient (par. 0216; “Measuring an elapsed time of a large number of measurement cycles can be used to generate an average time period of a measurement cycle when change in the parameter being measured occurs slowly in relation to physiological changes such as occurs in the muscular-skeletal system”); and a coupling element positioned between the pressure-responsive complex portion and the sensor measurement component and at least partially covering or encapsulating the sensor measurement component (Fig. 31; element 3112, 3114; par. 0227; “The force, pressure, or load applied to articular surface 3118 and 3120 is respectively transferred to surface 3112 and 3114 of structure 3102. It should be noted that surface 3112 and surface 3114 are compliant and not rigid. Each surface has sufficient compliance that allows the underlying sensors to compress. In one embodiment, surface 3112 and surface 3114 is thinned or made thin to achieve compliance”), wherein the coupling element is composed of a solid elastomeric material (par. 0227; “Alternatively, support structures 3112 and 3114 can comprise a material that is compliant such as a polymer material”).
Regarding claim 37, Stein discloses the pressure-responsive complex portion extends at least partially along an axis parallel to a longitudinal axis of the housing (Fig. 31; extension of element 3118, 3120 and 3122; par. 0193]; “These parameters can be evaluated by sensor measurement, alignment, direction, or position as well as movement, rotation, or acceleration along an axis or combination of axes by wireless sensing modules or devices positioned on or within a body”).
Regarding claim 38, Stein discloses (Fig. 31) the pressure-responsive complex portion extends at least partially radially around the housing in a direction approximately perpendicular to a longitudinal axis of the housing.
Regarding claim 39, Stein discloses (Fig. 31) the pressure-responsive complex portion has a same thickness as the housing.
Regarding claim 40, Stein discloses the pressure-responsive complex portion is configured to transmit the one or more physiological parameters to the sensor measurement component (par. 0223; “A force, pressure, or load applied to articular surfaces 3118 and 3120 is respectively applied to a support surface 3112 and a support surface 3114 of structure 3102. The support surfaces 3112 and 3114 transfer the force, pressure, or load to a corresponding sensor array. The load pads 3108 are at predetermined locations corresponding to articular surfaces 3118 and 3120. Load pads 3108 transfer the force, pressure, or load at the predetermined location to the underlying sensors for measurement”).
Regarding claim 41, Stein discloses a sensor device for an implantable medical device (Abstract; “The orthopedic implant can include electronic circuitry, a power source, and one or more sensors for measuring a parameter of the muscular-skeletal system or a parameter of in proximity to the implant”), the sensor device comprising: a housing (par. 0225; “Electronic circuitry 3110 can be fitted in the cavity formed by housing 3122 of structure 3102. In one embodiment, the cavity is formed in an unloaded or lightly loaded area of prosthetic component 3100”), wherein the housing includes a pressure-responsive complex region (par. 0221; “A force, pressure, or load applied to articular surfaces 3118 and 3120 apply a corresponding force, pressure, or load to support surfaces 3112 and 3114”), and wherein the pressure-responsive complex region has a same thickness as the housing (par. 0224); a sensor measurement component positioned within the housing and aligned with the pressure-responsive complex portion (element 3106, 3120; par. 0225; “Interconnect 3106 and the sensors therein couple to electronic circuitry 3110. Interconnect 3106 include interconnect that couples the sensors to electronic circuitry 3110”), wherein, when the medical device is implanted within a patient (par. 0074; “sensor 100 can be used for other joint surgeries; it is not limited to knee replacement implant or implants”), the sensor measurement component is configured to measure one or more physiological parameters of the patient (par. 0216; “Measuring an elapsed time of a large number of measurement cycles can be used to generate an average time period of a measurement cycle when change in the parameter being measured occurs slowly in relation to physiological changes such as occurs in the muscular-skeletal system”); and a coupling element positioned between the pressure-responsive complex portion and the sensor measurement component and at least partially covering or encapsulating the sensor measurement component (Fig. 31; element 3112, 3114; par. 0227; “The force, pressure, or load applied to articular surface 3118 and 3120 is respectively transferred to surface 3112 and 3114 of structure 3102. It should be noted that surface 3112 and surface 3114 are compliant and not rigid. Each surface has sufficient compliance that allows the underlying sensors to compress. In one embodiment, surface 3112 and surface 3114 is thinned or made thin to achieve compliance”), wherein the coupling element is composed of a solid elastomeric material (par. 0227; “Alternatively, support structures 3112 and 3114 can comprise a material that is compliant such as a polymer material”).
Regarding claim 42, Stein discloses (Fig. 31) the pressure-responsive complex region extends at least partially along an axis parallel to a longitudinal axis of the housing.
Regarding claim 43, Stein discloses (Fig. 31) the pressure-responsive complex region extends at least partially radially around the housing in a direction approximately perpendicular to a longitudinal axis of the housing.
Regarding claim 44, Stein discloses (Fig. 31 surface area of 3120) the pressure-responsive complex region includes at least 5% of a surface area of the housing.
Regarding claim 45, Stein discloses (Fig. 31 surface area of 3120) the pressure-responsive complex region includes at least 50% of a surface area of the housing.
Regarding claim 46, Stein discloses (par. 0223; “A force, pressure, or load applied to articular surfaces 3118 and 3120 is respectively applied to a support surface 3112 and a support surface 3114 of structure 3102. The support surfaces 3112 and 3114 transfer the force, pressure, or load to a corresponding sensor array. The load pads 3108 are at predetermined locations corresponding to articular surfaces 3118 and 3120. Load pads 3108 transfer the force, pressure, or load at the predetermined location to the underlying sensors for measurement”) the pressure-responsive complex region is configured to transmit the one or more physiological parameters to the sensor measurement component.
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 15 is rejected under 35 U.S.C. 103 as being unpatentable over Stein (U.S. 2016/0089079). Stein discloses the claimed invention except for the barrier component is composed of Nitinol. It would have been obvious to one of ordinary skill in the art at the time of the invention to provide a barrier component of Nitinol, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792
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