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 .
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.
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 1, 2, 4, 5, 8-10, 12, 14-16, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Fields et al. (US 2020/0022735 A1) in view of Wilder et al. (US 2016/0128573 A1) and Toth et al. (US 2015/0164401 A1).
Claim 1. Fields discloses a spinal implant (screw 20, anchoring member 30, set screw 50, and washer 60) comprising:
an electronics portion (set screw 50) including a removable electronics bundle (integrated circuits 302, electronics components 304, and strain gauge 306) including an electronics assembly (integrated circuits 302 and electronics components 304) and a battery (para. 0076 states that integrated circuits 302 can be battery powered and include batteries);
at least one antenna (antenna 300) in electrical communication with the electronics assembly (via connecting member 308); and
at least one sensor (strain gauge 306 and temperature sensor 712) in electrical communication with the electronics assembly, wherein the at least one antenna is located external to the electronics portion and is configured to transmit information received from the at least one sensor to an external device (Figs. 1-4A and 16; paras. 0052-0062 and 0086).
Claim 2. Fields discloses wherein:
the electronics bundle has at least one antenna interface (connecting member 308); and
the electronics portion is configured to receive the removable electronics bundle (Figs. 1-4A and 16; paras. 0052-0062 and 0086).
Claim 4. Fields discloses wherein the at least one sensor is located within the removable electronics bundle (Figs. 1-4A and 16; paras. 0052-0062 and 0086).
Claim 5. Fields discloses wherein:
the spinal implant comprises a pedicle screw (see para. 0072) including a set screw (set screw 50);
the removable electronics bundle has at least one antenna interface (connecting member 308); and
the set screw is configured to receive the removable electronics bundle (Figs. 1-4A and 16; paras. 0052-0062 and 0086).
Claim 8. Fields discloses wherein:
the spinal implant comprises a pedicle screw (see para. 0072); and
the at least one antenna is configured to flexibly extend away from the pedicle screw (Fig. 4A shows that antenna 300 extends at least partially upward from set screw 50 – thus antenna 300 extends away from the pedicle screw; para. 0086 states that antenna 300 can include a RFID coil – it is well-known that a coil would have at least a minimal amount of flexibility) (Figs. 1-4A and 16; paras. 0052-0062 and 0086).
Claim 9. Fields discloses wherein the at least one sensor comprises at least one temperature sensor (temperature sensor 712) configured to measure a temperature of a surgical site (Figs. 1-4A and 16; paras. 0052-0062 and 0086).
Claim 10. Fields discloses wherein the at least one sensor comprises at least one strain gauge (strain gauge 306) configured to measure a localized force experienced by the spinal implant (Figs. 1-4A and 16; paras. 0052-0062 and 0086).
Claim 12. Fields discloses wherein the at least one sensor is chosen from the group comprising: accelerometer, gyroscope, strain gauge (strain gauge 306), pressure sensor, pH sensor, impedance sensor, optical sensor, and temperature sensor (temperature sensor 712) (Figs. 1-4A and 16; paras. 0052-0062 and 0086).
Claim 14. Fields discloses a surgical site monitoring system comprising:
a first spinal implant (screw 20, anchoring member 30, set screw 50, and washer 60) comprising:
a first electronics portion (set screw 50) including a first removable electronics bundle (integrated circuits 302, electronics components 304, and strain gauge 306) including a first electronics assembly (integrated circuits 302 and electronics components 304) and a first battery (para. 0076 states that integrated circuits 302 can be battery powered and include batteries) therein;
at least one first antenna (antenna 300) in electrical communication with the first electronics assembly (via connecting member 308); and
at least one first sensor (strain gauge 306 and temperature sensor 712) in electrical communication with the first electronics assembly, wherein the at least one first antenna is located external to the first electronics portion and is configured to transmit first information received from the at least one first sensor to an external device; and
a second spinal implant (screw 20, anchoring member 30, set screw 50, and washer 60; see Fig. 16, which shows four spinal implants) comprising:
a second electronics portion (set screw 50) including a second removable electronics bundle (integrated circuits 302, electronics components 304, and strain gauge 306) including a second electronics assembly (integrated circuits 302 and electronics components 304) and a second battery (para. 0076 states that integrated circuits 302 can be battery powered and include batteries) therein;
at least one second antenna (antenna 300) in electrical communication with the second electronics assembly (via connecting member 308); and
at least one second sensor (strain gauge 306 and temperature sensor 712) in electrical communication with the second electronics assembly, wherein the at least one second antenna is located external to the second electronics portion and is configured to transmit second information received from the at least one second sensor to the external device (Figs. 1-4A and 16; paras. 0052-0062 and 0086).
Claim 15. Fields discloses wherein:
the first and second electronics bundles have at least one antenna interface (connecting member 308); and
the first and second electronics portions are configured to receive the first and second removable electronics bundles (Figs. 1-4A and 16; paras. 0052-0062 and 0086).
Claim 16. Fields discloses wherein the at least one first sensor and the at least one second sensor comprise at least one temperature sensor (temperature sensor 712) configured to collect temperature measurements within a patient (Figs. 1-4A and 16; paras. 0052-0062).
Claim 18. Fields discloses wherein the first and second spinal implants each comprises a pedicle screw (see para. 0072) or an interbody cage (Figs. 1-4A and 16; paras. 0052-0062 and 0086).
Claim 19. Fields discloses wherein the first and second antennas are each configured to flexibly extend away from the first and second spinal implants, respectively (Fig. 4A shows that antenna 300 extends at least partially upward from set screw 50 – thus antenna 300 extends away from the spinal implant; para. 0086 states that antenna 300 can include a RFID coil – it is well-known that a coil would have at least a minimal amount of flexibility) (Figs. 1-4A and 16; paras. 0052-0062 and 0086).
Fields fails to disclose wherein the removable electronics bundle is a housing defining a sealed cavity for supporting the electronics assembly and the battery therein (claim 1), wherein the at least one antenna is a monopole antenna (claim 1), wherein the at least one monopole antenna extends away from the housing (claim 1), wherein the housing comprises a hermetically sealed, removable electronics cartridge (claim 2), wherein the housing comprises a removable electronics cartridge (claim 5), wherein the at least one antenna is configured extend into tissue surrounding the pedicle screw (claim 8), wherein the first removable electronics bundle is a first housing defining a first sealed cavity for supporting the first electronics assembly and the first battery therein (claim 14), wherein the at least one first antenna is a monopole antenna (claim 14), wherein the at least one first monopole antenna extends away from the first housing (claim 14), wherein the second removable electronics bundle is a second housing defining a second sealed cavity for supporting the second electronics assembly and the second battery therein (claim 14), wherein the at least one second antenna is a monopole antenna (claim 14), wherein the at least one second monopole antenna extends away from the second housing (claim 14), and wherein the first and second housings comprise hermetically sealed, removable electronics cartridges (claim 15).
However, with respect to the antenna, it is noted that Fields states that the antenna can take a variety of forms (see para. 0057).
Wilder teaches a spinal implant (apparatus 100) comprising: an electronics portion (bridge 102) including a removable electronics bundle (housing 104 including circuitry 130) in the form of a housing (housing 104; para. 0013 states that housing 104 is mounted to bridge 102) defining a sealed cavity (interior 128) for supporting an electronics assembly (circuitry 130) therein, wherein the housing comprises a hermetically sealed (see para. 0024), removable electronics cartridge (housing 104 can be considered to be a cartridge) (Figs. 1-5; paras. 0013-0027).
Toth teaches an implant comprising: an electronics portion including a housing (housing 2510) for supporting an electronics assembly (microcircuits 2515 and sensing tips 2520 and 2525); and a flexible monopole antenna (tail 2530 – see para. 0357, which states that tail 2530 functions as a whip antenna) in electrical communication with the electronics assembly (see para. 0357), wherein the monopole antenna extends away from the housing into tissue surrounding the implant (see Fig. 25b) and is configured to transmit information to an external device (see para. 0357) (Figs. 25a-25b; paras. 0356-0359). Regarding a whip antenna, the Examiner notes that Applicant indicates that a whip antenna is a monopole antenna (see para. 0042 of Applicant’s disclosure).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spinal implants of Fields such that the removable electronics bundle is a housing defining a sealed cavity for supporting the electronics assembly and the battery therein (claim 1), the housing comprises a hermetically sealed, removable electronics cartridge (claim 2), the housing comprises a removable electronics cartridge (claim 5), the first removable electronics bundle is a first housing defining a first sealed cavity for supporting the first electronics assembly and the first battery therein (claim 14), the second removable electronics bundle is a second housing defining a second sealed cavity for supporting the second electronics assembly and the second battery therein (claim 14), and the first and second housings comprise hermetically sealed, removable electronics cartridges (claim 15), as suggested by Wilder, as the use of such a hermetically sealed housing would protect the internal electronics from exposure to bodily fluids and tissue. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spinal implants of Fields such that the at least one antenna is a monopole antenna (claim 1), the at least one monopole antenna extends away from the housing (claim 1), the at least one antenna is configured extend into tissue surrounding the pedicle screw (claim 8), the at least one first antenna is a monopole antenna (claim 14), the at least one first monopole antenna extends away from the first housing (claim 14), the at least one second antenna is a monopole antenna (claim 14), and the at least one second monopole antenna extends away from the second housing (claim 14), as suggested by Toth, as such is merely a substitution of one type of antenna for another, wherein both types of antenna can transmit information received from electronic components to an external device.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Fields et al. (US 2020/0022735 A1) in view of Wilder et al. (US 2016/0128573 A1) and Toth et al. (US 2015/0164401 A1) as applied to claim 2 above, and further in view of Jackson et al. (US 2014/0214097 A1).
Fields, Wilder, and Toth fail to teach wherein the removable electronics cartridge has a threaded exterior that mates with the electronics portion (claim 3).
Jackson teaches that an inner component (inner plug 20) can be secured to an outer component (outer structure 19) by mating of a threaded exterior (thread 232) of the inner component with a threaded interior (thread 210) of the outer component (Figs. 16-21).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the spinal implant of Fields such that the removable electronics cartridge has a threaded exterior that mates with the electronics portion (claim 3), as suggested by Jackson, as it is well-known in the art to use a threaded connection to secure one component to another.
Claims 13 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Fields et al. (US 2020/0022735 A1) in view of Wilder et al. (US 2016/0128573 A1) and Toth et al. (US 2015/0164401 A1) as applied to claims 1 and 14 above, and further in view of Caylor (US 2008/0133009 A1).
Fields, Wilder, and Toth fail to teach wherein the battery is configured to be inductively recharged (claim 13) and wherein at least one of the first battery and the second battery are configured to be inductively recharged (claim 20).
Caylor teaches an electronics assembly (circuitry 100) and battery (power source 116; para. 0042 states that power source 116 can be a battery), wherein the battery is configured to be inductively recharged (see para. 0042), and wherein an inductively charged battery is one of a variety of batteries that can provide the needed power to the electronics assembly (see para. 0042) (Fig. 2; para. 0042).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the spinal implants of Fields such that the battery is configured to be inductively recharged (claim 13) and at least one of the first battery and the second battery are configured to be inductively recharged (claim 20), as suggested by Caylor, as an inductively charged battery is one of a variety of batteries that can provide the needed power to an electronics assembly.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 14 have been considered but are moot because 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.
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 JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571)272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773