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
The information disclosure statements (IDS) submitted on 04/05/23 and 12/22/22 have been considered by the examiner.
Claim Objections
Claims 60, 61, 64, 69 and 71 are objected to because of the following informalities:
Claims 60 and 61 recite the term “the instrument body”. Does this refer to the instrument body recited in claim 59? Examiner notes claims 60 and 61 are not dependent from claim 59
Claim 64 recites the term “the actuator”. Does this refer to the drill actuator recited in claim 62? Again, Examiner notes claim 64 is not dependent from claim 62.
Claim 69 recites the term “the lumen”. A lumen is not previously mentioned
Claim 71: recites the limitations
“the biosensor”. Does this refer to the microbead biosensor recited in claim 69?
“recovery energy”. Examiner notes this should recite “recover energy”
“a batter”. Examiner notes this should recite “a battery”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 58-61, 65, 66 and 68 are rejected under 35 U.S.C. 103 as being unpatentable over Giordano (DE 102005014624 A1) and in further view of Nycz (U.S. Patent Application Publication 2009/0187120 A1)
Giordano and Nycz were applied in the Applicant’s IDS submitted on 12/22/22
Regarding claim 58, Giordano teaches a device for implantation of an implant [fig. 17, element 146; par. 156] into a bone segment [fig. 1, element 10] comprising: a hollow trocar [fig. 1, element 12] for accessing a subject's bone [par. 132], the trocar having a sharp tip for piercing tissue such that a distal tip segment of the trocar can be positioned adjacent to a target bone location [fig. 16, element 12; par. 153 “Using the edge 48 of the guide instrument 12, a defined, circular cut 168 is made” Examiner notes the tip of the guide instrument, 48 is sharp enough to cut tissue], a drill cartridge [fig. 16, element 26] for forming a cavity in a bone, the drill cartridge configured to facilitate passage of a drill through a lumen of the trocar to form a cavity in the bone segment at the target location [par. 154, 155], and an implant cartridge [fig. 17, element 28] configured for passage of an implant through the trocar to implant the implant within the cavity formed by the drill [par. 156],
However, Giordano does not teach a device for implantation of a biosensor into a bone segment
Nycz teaches a device for implantation of a biosensor into a bone segment [fig. 1, element 120; par. 8, 30]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Giordano, to incorporate a device for implantation of a biosensor into a bone segment, for detecting characteristics of joint tissues and to maintain the sensor in a fixed position in the bone, as evidence by Nycz [par. 8]
Regarding claim 59, Giordano further teaches the device further comprises an instrument body for storing the drill cartridge [fig. 1, element 24; par. 134, Examiner notes the perforation instrument 24 guides the drill] and the biosensor cartridge [fig. 1, element 28; par. 147, 148; Examiner notes the insertion instrument 28 guides the implant].
Regarding claim 60, Giordano further teaches the trocar is releasably couplable to the instrument body and, optionally, also includes a Luer-lock type coupler for connecting the trocar to the instrument body [par. 147, “an internal thread section corresponding to the external thread section 142 is provided, so that the insertion instrument 28 can be screwed to the guide instrument 12 on the proximal side”].
Regarding claim 61, Giordano further teaches the instrument body further comprises a selector for aligning the drill cartridge or the biosensor cartridge with the trocar lumen [fig. 10, element 142; par. 95, 147, Examiner notes the threaded portions allow the implant cartridge to be fixed to guide instrument]
Regarding claim 65, Giordano further teaches wherein the biosensor cartridge further comprises a cylindrical chamber for storing at least one biosensor prior to implantation [fig. 10, element 136; par. 147, 148]
Regarding claim 66, Giordano further teaches wherein the biosensor cartridge further comprises an implantation actuator, and wherein optionally the implantation actuator comprises a piston [fig. 13, element 32; par. 150; Examiner notes the element 32 is the implantation actuator].
Regarding claim 68, Giordano further teaches wherein the device further comprises a stop for limiting the penetration of the drill, biosensor, or both into the bone segment [fig. 12, element 126; par. 146]
Claims 62-64 rejected under 35 U.S.C. 103 as being unpatentable over Giordano and Nycz and in further view of Coppedge (U.S. Patent Application Publication 2019/0314059)
Regarding claim 62, Giordano and Nycz teach device for implantation of a biosensor into a bone segment, as disclosed above.
However, Giordano and Nycz do not teach wherein the drill cartridge further comprises a drill actuator for the drill.
Coppedge teaches wherein the drill cartridge further comprises a drill actuator [fig. 8, element 122] for the drill [par. 127].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Giordano and Nycz, for activating the motor to effectuate the gear box and extended gear shaft to rotate the stylet and cannula simultaneously for drilling within a target patient's skin and bone, as evidence by Coppedge [par. 12]
Regarding claim 63, Coppedge further teaches wherein the drill cartridge comprises a rotatable shaft [fig. 8, element 119] with a drill tip [fig. 8, element 116] disposed at its distal end [par. 127].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Giordano and Nycz, to incorporate the drill cartridge comprises a rotatable shaft with a drill tip disposed at the distal end, as the drive shaft 119 provides the necessary rotation of the stylet 116 and attached cannula 114 during operation, as evidence by Coppedge [par. 127]
Regarding claim 64, Coppedge further teaches wherein the actuator further comprises a drive coupler [fig. 8, element 120] for coupling the rotatable shaft [fig. 8, element 119] to a rotary motor [fig. 8, element 122; par. 127]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Giordano and Nycz, to incorporate the actuator further comprises a drive coupler for coupling the rotatable shaft to a rotary motor, as the drive shaft 119 provides the necessary rotation of the stylet 116 and attached cannula 114 during operation, as evidence by Coppedge [par. 127]
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over Giordano and Nycz and in further view of Giordano (U.S. Patent Application Publication 2015/0150617), hereby referred to as Giordano 2015
Regarding claim 67, Giordano and Nycz teach a device for implantation of a biosensor into a bone segment, as disclosed above.
However, Giordano and Nycz do not teach wherein the implantation actuator further comprises a pneumatic coupler for coupling the piston to a pneumatic pressure source
Giordano 2015 teaches wherein the implantation actuator further comprises a pneumatic coupler [fig. 2A, element 50] for coupling the piston to a pneumatic pressure source [par. 20, 57-60]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Giordano and Nycz, to incorporate the implantation actuator further comprises a pneumatic coupler for coupling the piston to a pneumatic pressure source, for driving the bone pin into bone, as evidence by Giordano 2015 [par. 60]
Claims 69-71 are rejected under 35 U.S.C. 103 as being unpatentable over Nycz and in further view of Trabish (U.S. Patent Application Publication 2020/0405239 A1)
Regarding claim 69, Nycz teaches a microbead biosensor [fig. 1, element 120; par. 61, “the sensor has a diameter less than 4mm”] for implantation into a bone segment [par. 8] comprising: an external surface a sensor [par. 8] and configured for passage through the lumen of a trocar for implantation into a bone segment [par. 30 “the sensor 120 is sized and shaped such that it may be injected into the bone using an injection gun and/or catheter”], and at least one kinematic sensor [par. 59]
However, Nycz does not teach a shell for enclosing a sensor and at least one kinematic sensor disposed within the shell
Trabish teaches a shell for enclosing a sensor [fig. 1B, element 12; par. 83] and at least one kinematic sensor disposed within the shell [par. 57]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Nycz, to incorporate a shell for enclosing a sensor and at least one kinematic sensor disposed within the shell, for sealing the sensor in the implant, as evidence by Trabish [par. 83]
Regarding claim 70, Nycz further teaches wherein the kinematic sensor further comprises at least one sensor from the group of accelerometers, gyroscopes and magnetic sensors [par. 59].
Regarding claim 71, Nycz further teaches the biosensor further comprises a power source and, optionally, an energy harvesting device to recovery energy from movement of the bone segment, wherein optionally the power source comprises a battery or a contactless energy coupler [par. 35, 58].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791