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 .
Specification
The disclosure is objected to because of the following informalities: paragraph 0001 needs to be updated to reflect the status of copending applications 16/6722,921 (now US Patent No. 11,097,096) and 17/379,928 (now US Patent No. 12,201,829).
Within the claims and specification the word “Bluetooth” is used, this should read “Bluetooth®”.
Appropriate correction is required.
Claim Objections
Claims 3-17 objected to because each claim depend from claim 1 which has been cancelled. For the purposes of examination it will be assumed that the claims depend from claim 2.
Claim 2 recites “the second external device” in line 15, this language lacks proper antecedent basis, there is no previous “second” external device mentioned in claim two. It is assumed that this should read “the external device”. This claim is objected to as opposed to being rejected in that it is understood that the external device is singular and there is not a second external device because there is a programmer which is also external.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 11 depends from claim 10, claim 10 specifies that the charging device includes a third communication link to provide power “a third communication link to charge the power supply”. Claim 11 then specifies that this link is BLE. Bluetooth, including BLE, is a wireless communication protocol and is not known to transfer power via a communication link. The specification provides no disclosure as to how applicant intends to use BLE to charge the power supply, therefore the specification is lacking written description for the claimed matter of claim 11. For the purpose of examination it will be assumed that the BLE is for communication as is known.
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.
Claims 2-5, 7, 9-10, 12-16, 18-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Kaula et al. US 2016/0361545 in view of Freeberg et al. US 2007/0049983.
Regarding claim 2: Kaula discloses a medical system19 (figure 2B) comprising;
an implantable device 19 (figure 2B) comprising:
a stimulation element (“electrodes”, paragraph 0037) which delivers stimulation to the patient (paragraph 0037) and;
a controller 415 (“microcontroller”, paragraph 0076 and figure 8) which provides stimulation signals to the electrode (paragraph 0077; “The stimuli are provided by a stimulation portion 425 in response to commands from the microcontroller 415.”);
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a programmer 22 (figure 2B) comprising a user interface to receive user input to change a stimulation program (paragraph 0038; the programmer 22 includes keys and a display considered to be a user interface, the programmer 22 permits a clinician to program the neurostimulation therapy); and
an external device 23 (“patient programmer”, figure 2B) coupled to the programmer via a first communication link and to the implanted device via a second communication link, the first and second communication links are separate, and
wherein the external device 23 (figure 2B) is configured to transmit data to the implanted device via the second communication link to change the stimulation program based on the user input, the data comprising a command to deliver the stimulation energy based on the changed stimulation program (paragraph 0039; the external device 23 transmits and receives data as shown in figure 2B by the bidirectional arrow, the external device 23 can alter the stimulation program based on duration, amplitude, pulse width and pulse rate adjustments).
However, Kaula does not disclose that the programmer is configured to monitor, via the first communication link, the second communication link between the external device and the implanted device. Freeberg however teaches of a system which assesses RF link quality (abstract). In figure 4 of Freeburg the IMD 410 is connected to the programmer 420 via the arrow. A second, external device 430 receives RF communication between the implant and the programmer (paragraph 0024). It is further taught by Freeburg that the link quality assessment device can be a stand-alone device or contained within the programmer ( paragraph 0022) and is used to assess the viability of the telemetry link between the programmer and the implant (paragraph 0022). Therefore, the components of the LQA 430 can be within a stand-alone unit or within a programmer, demonstrating that the LAQ can be within any of the external devices. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Kaula to include a link quality assessment device/circuit taught by Freeburg within the programmer or the external device of Kaula to assess telemetry links, as taught by Freeburg in order to determine link quality for radio frequency transmission (Freeburg, abstract).
Regarding claim 3: Kaula discloses patient programmer 23/104 (figures 2B and 4 respectively), the programmer 104 is shown to have an antenna in figure 4 which is part of communication module 154. The communication module 154 further includes a transceiver 172 (figure 4) to communicate with the IPG (paragraph 0048) which is considered to drive the antenna. The programmer 140 (figure 4) also includes a power supply 180 (figure 4) which supplies power to the components of the programmer (paragraph 0049) and a controller 152 (figure 4) to control the components of the pocket controller (paragraph 0047).
Regarding claim 4: Kaula discloses that the IMD 20 (figures 2A and 8) includes an antenna 412 (figure 8) which receives data from the external device via the communication link (paragraphs 0047, 0076).
Regarding claim 5: Kaula discloses that the patient programmer 23/104 (figures 2B and 4 respectively) is a pocket programmer which is approximately the size of a key fob (paragraph 0043) and can fit into a pocket. In this rejection the pocket of the patient’s clothing is considered to be the attachment device, and the fabric holding the pocket controller would be the housing for slidably receiving the external device. Kaula further disclose the sue of a key ring or lanyard (paragraph 0050).
Regarding claim 7: Kaula disclose that the external device transmits power to the implant (paragraphs 0048-49).
Regarding claim 9: Kaula discloses that the IMD includes an antenna 412 (figure 8) which receives data from the external device 23 (figure 2B, paragraphs 0048, 0076) via the second communication link; and a receiver 405 (“transceiver”, figure 8) which receivers the data from the antenna 412 (figure 4).
Regarding claim 10: Kaula discloses that the external device 23 /104 (figures 2B/4) includes a power supply 180 (figure 4) and the system further includes a charging device configured to communicate with the external device via a third communication link to charge the power supply (paragraphs 0042, 0049 and 0050).
Regarding claim 12: Kaula discloses that the programmer 22 (figure 2B) is a portable computer (paragraph 0105).
Regarding claim 13: Kaula discloses that the programmer 22 (figure 2B) is a first programmer and the system further comprises a second programmer 106 (paragraph 0042) communicably coupled to the external device via a third communication link (paragraphs 0042, 0049-50).
Regarding claim 14: Kaula discloses that the user interface is a first user interface, and the second programmer 106 includes a second user interface 250 (figure 3, paragraph 0033) which receives user input to change stimulation programs (paragraphs 0057-59, “operating parameters”, paragraphs 0044 and 0058).
Regarding claims 15-16: Kaula discloses that the user input includes modification of stimulation amplitude and settings (paragraph 0044).
Regarding claim 18: Kaula discloses a medical system19 (figure 2B) comprising;
an implantable device 19 (figure 2B) comprising:
a stimulation element (“electrodes”, paragraph 0037) which delivers stimulation to the patient (paragraph 0037) and;
a controller 415 (“microcontroller”, paragraph 0076 and figure 8) which provides stimulation signals to the electrode (paragraph 0077; “The stimuli are provided by a stimulation portion 425 in response to commands from the microcontroller 415.”);
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a programmer 22 (figure 2B) comprising a user interface to receive user input to change a stimulation program (paragraph 0038; the programmer 22 includes keys and a display considered to be a user interface, the programmer 22 permits a clinician to program the neurostimulation therapy); and
an external device 23 (“patient programmer”, figure 2B) coupled to the programmer via a first communication link and to the implanted device via a second communication link, the first and second communication links are separate, and
wherein the external device 23 (figure 2B) is configured to transmit data to the implanted device via the second communication link to change the stimulation program based on the user input, the data comprising a command to deliver the stimulation energy based on the changed stimulation program (paragraph 0039; the external device 23 transmits and receives data as shown in figure 2B by the bidirectional arrow, the external device 23 can alter the stimulation program based on duration, amplitude, pulse width and pulse rate adjustments).
Regarding claim 19: Kaula discloses that the user input includes modification of stimulation amplitude and settings (paragraph 0044).
Regarding claim 21: Kaula discloses that the external device can be on a lanyard or placed in a pocket (paragraph 0050), which is removable.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kaula et al. US 2016/0361545 in view of Freeberg et al. US 2007/0049983 and further in view of Mashiach et al. US 2014/0379049.
Regarding claim 6: Kaula/Freeberg discloses the claimed invention however Kaula/Freeberg does not disclose the use of an adhesive to couple the external device housing to a patient. Mashiach however teaches of an external unit 120 (figure 1) which includes a housing that includes an adhesive to attach the external unit to a desired location (paragraph 0048). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Kaula/Freeberg to include an adhesive on the housing of the external device, as taught by Mashiach, in order to adhere the external device to an appropriate location.
Claims 8, 11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kaula et al. US 2016/0361545 in view of Freeberg et al. US 2007/0049983 and further in view of Reed et al. US 2016/0030746.
Regarding claims 8, 11 and 20: Kaula/Freeberg discloses the claimed invention however Kaula/Freeberg does not disclose the use of Bluetooth® low energy. It is noted that Kaula discloses the use of Bluetooth® (paragraphs 0040, 0069 and 0086). Reed teaches of using either Bluetooth® or Bluetooth low energy® (paragraph 0220). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Kaula/Freeberg to include the use of Bluetooth low energy®, as taught by Reed, in order to wirelessly communicate (Reed, paragraph 0220).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kaula et al. US 2016/0361545 in view of Freeberg et al. US 2007/0049983 and further in view of Sharma et al. US 2014/0228911.
Regarding claim 17: Kaula/Freeberg discloses the claimed invention however Kaula/Freeberg does not disclose that the patient can indicated using user input that they have transitioned from and upright to a supine position. Sharma however teaches of a user input interface which allows the user to input whether they are supine or non-supine to enable a supine stimulation mode. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Kaula/Freeberg to include a patient indication at an external device of either an upright or supine position, as taught by Sharma, in order to apply the appropriate stimulation.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Kaula et al. US 2016/0361545 in view of Freeberg et al. US 2007/0049983 and further in view of Skelton et al. US 2010/0010584.
Regarding claim 22: Kaula/Freeberg discloses the claimed invention however Kaula/Freeberg does not disclose that the external device automatically detects patient posture. Skelton however teaches of automatically adjust stimulation based on a sensed posture state either from a sensor in the IMD or in “another device” that communicates with the IMD (paragraph 0005). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Kaula/Freeberg to include a posture state module in the external device (“another device”), as taught by Skelton, in order to automatically adjust stimulation based on posture.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 18, 20 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 and 21 of U.S. Patent No. 12,201,829. Although the claims at issue are not identical, they are not patentably distinct from each other as shown below.
18/976,997
12,201,829
Claim 18.
A medical system for a patient, comprising: an implantable device comprising: at least one stimulation element configured to deliver stimulation energy to the patient; and a controller configured to control the at least one stimulation element;
a first external device configured to adjust stimulation parameters of the stimulation energy; and
a second external device communicably coupled to the first external device via a first communication link and to the implantable device via a second, different communication link,
wherein the second external device is configured to transmit data to the implantable device via the second communication link to change a stimulation program based on the adjusted stimulation parameters,
the data comprising a command to deliver the stimulation energy based on the changed stimulation program, and wherein the first external device is further configured to monitor, via the first communication link, the second communication link between the second external device and the implantable device.
Claim 1.
A medical apparatus for a patient, comprising: an implantable device comprising: at least one stimulation element configured to deliver stimulation energy to the patient; and control structure configured to control the at least one stimulation element;
a first external device comprising a user interface including a patient posture interface configured to receive user input to change a stimulation program based on the patient position; and
a second external device communicably coupled to the first external device via a first communication link and to the implantable device via a second, different communication link,
wherein the second external device is configured to transmit data to the implantable device via the second communication link to change the stimulation program based on the user input,
the data comprising a command to deliver the stimulation energy based on the changed stimulation program, and wherein the first external device is further configured to monitor, via the first communication link, the second communication link between the second external device and the implantable device.
Claim 20.
The system of claim 18, wherein the first communication link comprises a near field communication (NFC) network, an RFID network, or a Bluetooth low energy (BLE) network.
Claim 21.
The apparatus according to claim 1, wherein the first communication link comprises a near field communication (NFC) network, and RFID network, or a Bluetooth low energy (BLE) network.
Claim 22.
The system of claim 18, wherein the external device is configured to automatically detect a patient position.
Claim 4.
The apparatus according to claim 3, wherein the second external device is configured to automatically detect when the patient is in an upright or a supine position.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
Prosecution Insights