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 .
This communication is in response to response filed on 07/09/2026.
In the application claims 1-26 are pending.
Applicant’s election without traverse of claims 1-4, 6-11, 20-21, and 24 in the reply filed on 07/09/2026 is acknowledged. In view of the cited prior art, non-elected claims were reconsider; however, it would place an undue burden at the Office to search and cite additional art, and make additional prima facie case of obviousness for the non-elected claims.
Applicant is requested to amend the claimed term “and/or” with either “and” or “or,” in an effort to establish clear bounds of claimed limitations.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a first external device, configured to control the IMD using a wireless connection, and to detect the presence of a second external device…” in claim 1, is interpreted to be “an IMD may be configured to wirelessly communicate with one or more external devices. Such devices include, e.g., a patient remote control device 104 provided to or accessible by the subject (alternatively referred to as a “PRC device” herein), that allows the subject to access, view, and/or control one or more settings or functions of the IMD. The PRC device 104 may comprise a dedicated hardware device, or software executed on a general-purpose computer or other electronic device (e.g., software executed on a tablet or laptop computer) capable of wirelessly communicating with the IMD.” See ¶ 0032;
“a second external device configured to wirelessly communicate with and control the IMD” in claim 1, is interpreted to be “the IMD may also be configured to wireless communicate with a separate external device operated by a clinician programmer (alternatively referred to as a “CP” herein). The CP device 105 may provide any or all of the functionality provided by the PRC device 104… the CP device 105 is understood to be an external electronic device operated by a medical professional and capable of wireless communication with the IMD, that provides an interface to access, view, and/or control one or more settings or functions of the IMD.” See ¶ 0033
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites, “the first external device received the signal from a cloud-based infrastructure.” However, the preceding claims 8 has establish “after receiving a signal from the second external device.” Claim 11 is improperly changing the subject matter established in the preceding claims, and makes it unclear to the Examiner, subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
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.
Claim(s) 1-4, 6-11, 20-21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Helvick, Richard et al. (US 2020/0298011 A1), and further in view of Grubis (US 2018/0007639 A1).
Consider claim 1, Helvick teaches, a system for managing wireless communication with an implanted medical device (Helvick’s IPG), Helvick teaches, “a method for managing a wireless communication between an implantable medical device and at least two external devices” See ¶ 0007, comprising:
an implantable medical device (“IMD”), (Helvick’s IPG), Helvick teaches, “system 1 including an implantable medical device IPG, a first external device PR and a second external device CP.” See ¶ 0032;
a first external device (Helvick’s patient remote PR), configured to control the IMD using a wireless connection, Helvick teaches, “the implantable medical device IPG is a pulse generator for spinal cord stimulation (SCS) that is implanted in the body of a patient. The first external device PR is a patient remote to be carried by the patient. In normal use, the patient remote PR continuously maintains a wireless connection BLE based on the Bluetooth Low Energy protocol with the implanted pulse generator IPG. The patient remote PR has a first user interface UX1, which allows the patient, e.g., to retrieve information on the operation of the pulse generator and input control commands.” See ¶ 0032,
and the first external device (Helvick’s patient remote PR), configured to detect the presence of a second external device (Helvick’s clinician's programmer CP), configured to wirelessly communicate with and control the IMD, Helvick teaches, “When the patient has a follow-up session with the clinician, a handoff from the patient remote PR to the clinician's programmer CP needs to be effected. The handoff may correspond to a transition from the normal use situation as schematically illustrated in FIG. 1A to the follow-up situation as schematically illustrated in FIG. 1B.” See ¶ 0037;
wherein the first external device is configured to detect the presence of the [[second external device]], Helvick teaches, “the patient remote is connected and associated (step S1) with the implantable pulse generator IPG, in accordance with the normal-use situation depicted in FIG. 1A. The clinician then applies a magnet to the implantable pulse generator IPG, thereby causing the implantable pulse generator IPG to enter its search mode (step S2). For example, the magnet may be placed on or close to the skin of the patient in the vicinity of the implanted pulse director IPG for a predetermined minimum period of time, such as, e.g. 10 seconds, so as to activate the search mode.” See ¶ 0045, Helvick teaches “a blocking mode of the patient remote PR is activated in response to the activation of the search mode of the implantable pulse generator IPG, wherein, in the blocking mode, the patient remote PR is disconnected from the implantable pulse generator IPG and does not attempt to connect with the implantable pulse generator IPG.” See ¶ 0043, “The first user interface UX1 of the patient remote PR indicates the activation of the blocking mode to the patient.” See ¶ 0047, Nonetheless, in an analogous art, Grubis teaches, “method for wireless component monitoring. The method includes entering a low power mode to associate a radio frequency identification (RFID) component with a patient monitoring device within a first range. The method may also include entering a high power mode wherein the patient monitoring device is to detect the RFID component within a second range of the patient monitoring device, wherein the second range is larger than the first range.” See ¶ 0002. Grubis teaches, “At 502, a low power mode to associate a radio frequency identification (RFID) component with a patient monitoring device within a first range is entered. At block 504, a high power mode is entered. In the high power mode, the patient monitoring device is to detect the RFID component within a second range of the patient monitoring device, wherein the second range is larger than the first range.” See ¶ 0039, based on
a) an actual or estimated physical distance between the first external device and the second external device, the first external device and the IMD, and/or the second external device and the IMD; and/or, Grubis teaches, “a low power mode wherein the RFID transceiver communicates with one or more RFID components within a predefined first distance range of the patient monitor and associates the one or more RFID components with the patient monitoring device; and a high power mode wherein the patient monitoring device detects the RFID component within a predefined second distance range of the patient monitoring device,” See Claim 21.
[[b) geographic location data for the first external device, the second external device, and/or the IMD;]]
wherein the first external device is further configured to terminate the wireless connection used to control the IMD in response to
detecting the presence of the [[second external device]] magnet within a predetermined distance from the first external device and/or the IMD,
Helvick teaches, “the patient or the clinician may use the first user interface UX1 on the patient remote PR to activate a disconnected mode, in which the patient remote PR is and remains disconnected from the implantable pulse generator IPG. The clinician can then use the second user interface UX2 on the clinician's programmer to connect and associate the clinician's programmer CP to the implantable pulse generator IPG. At this point, the clinician may use the second user interface UX2 on the clinician's programmer CP to perform the follow-up procedures.” See ¶ 0038, Helvick teaches, “the patient remote is connected and associated (step S1) with the implantable pulse generator IPG, in accordance with the normal-use situation depicted in FIG. 1A. The clinician then applies a magnet to the implantable pulse generator IPG, thereby causing the implantable pulse generator IPG to enter its search mode (step S2). For example, the magnet may be placed on or close to the skin of the patient in the vicinity of the implanted pulse director IPG for a predetermined minimum period of time, such as, e.g. 10 seconds, so as to activate the search mode.” See ¶ 0045; nonetheless, it would be obvious in view of Grubis, wherein Grubis teaches, “a low power mode wherein the RFID transceiver communicates with one or more RFID components within a predefined first distance range of the patient monitor and associates the one or more RFID components with the patient monitoring device; and a high power mode wherein the patient monitoring device detects the RFID component within a predefined second distance range of the patient monitoring device,” See Claim 21;
and/or
[[based upon the geographic location data indicating that the first external device, the second external device, and/or the IMD are located at a predetermined geographic location.]]
It would have been obvious to one of ordinary skilled in the art at the time of invention (effective filing date for AIA application) to modify the invention of Helvick and place Helvick’s “patient remote PR is disconnected from the implantable pulse generator IPG” in “a disconnected mode” when “an RFID component” taught by Grubis, associated with Helvick’s clinician's programmer CP “within a predefined first distance range of the patient monitor and associates the one or more RFID components with the patient monitoring device” as suggested by Grubis, in effort to automatically detect RFID component, “the patient monitoring device is to detect the RFID component” See ¶ 0039 in an effort to “prevent[] incorrect medical care” See ¶ 0033.
Consider claim 2, the system of claim 1, wherein the IMD is an implantable pulse generator (“IPG”), Helvick teaches, “system 1 including an implantable medical device IPG,” See ¶ 0032.
Consider claim 3, the system of claim 1, wherein the first external device and/or the second external device is an electronic device configured to:
a) access or modify one or more settings of the IMD, “The patient remote PR has a first user interface UX1, which allows the patient, e.g., to retrieve information on the operation of the pulse generator and input control commands.” See Helvick ¶ 0032; and/or
b) wirelessly receive data from, or transfer data to, the IMD, “The first external device PR is a patient remote to be carried by the patient. In normal use, the patient remote PR continuously maintains a wireless connection BLE based on the Bluetooth Low Energy protocol with the implanted pulse generator IPG.” See Helvick ¶ 0032
Consider claim 4, the system of claim 1, wherein the first external device is a patient remote control device configured to be operated by a subject (i.e. patient) implanted with the IMD, See Helvick ¶ 0032-0033, and/or the second external device is a clinician programmer device configured to be operated by a medical professional (i.e. clinician), See Helvick ¶ 0036-0038.
Consider claim 6, the system of claim 1, wherein the first external device is configured to terminate the wireless connection used to control the IMD, Helvick ¶ 0038:
a) directly; or
b) by transmitting a signal to the IMD that triggers the IMD to terminate the wireless connection, Helvick teaches, “the patient or the clinician may use the first user interface UX1 on the patient remote PR to activate a disconnected mode,” See ¶ 0038.
Consider claim 7, the system of claim 6, wherein the IMD is configured to switch to a mode that only allows establishment of a wireless connection with the second external device for a predefined period of time, after receiving the signal from the first external device triggering the IMD to terminate the wireless connection, Helvick teaches, “the patient remote PR may include a timer, which automatically starts when the blocking mode is activated, wherein patient remote PR may be configured to automatically exit the blocking mode when the timer expires. The duration of the timer may be chosen so as to cover at least a typical duration of a follow-up procedure.” See ¶ 0049.
Consider claim 8, the system of claim 1, wherein the first external device is configured to terminate the wireless connection used to control the IMD, See Helvick ¶ 0038, after receiving a signal from the second external device, See Grubis ¶ 0045, Claim 21
Consider claim 9, the system of claim 8, wherein the first external device is further configured to switch to a disconnected mode wherein attempts to detect and wirelessly connect to the IMD are disabled, Helvick teaches, “a blocking mode of the patient remote PR is activated in response to the activation of the search mode of the implantable pulse generator IPG, wherein, in the blocking mode, the patient remote PR is disconnected from the implantable pulse generator IPG and does not attempt to connect with the implantable pulse generator IPG.” See Helvick ¶ 0043,
after receiving a signal from the second external device, See Grubis ¶ 0045, Claim 21
Consider claim 10, the system of claim 9, wherein the first external device is configured to remain in the disconnected mode:
a) for a predetermined period of time, wherein the period of time is optionally 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, or 60 minutes, or a period of time within a range defined by endpoints selected from any of the foregoing lengths of time, See Helvick ¶ 0049;
b) until a predetermined signal to exit disconnected mode is received, wirelessly, “Once the follow-up is completed, the clinician's programmer CP is disassociated and disconnected from the implantable pulse generator IPG. At this point, the implantable pulse generator IPG is no longer in its search mode, but in a normal mode, in which it may advertise with the search mode status “inactive.”” See ¶ 0048; and/or
c) based on manual input entered into an interface of the first external device, “first user interface UX1 of the patient remote PR indicates the activation of the blocking mode to the patient.” See ¶ 0047.
Consider claim 11, the system of claim 8, wherein the first external device received the signal from a cloud-based infrastructure. Examiner takes Office notice that is well-known in the prior art for a wireless communication device such as patient monitoring device to receive a signal from a cloud-based infrastructure, i.e. a remote server.
Consider claim 20, a method for managing wireless communication with an implanted medical device, comprising:
providing an implantable medical device (“IMD”);
providing a first external device, configured to control the IMD using a wireless connection, and to detect the presence of a second external device configured to wirelessly communicating with and control the IMD;
detecting, by the first external device, the presence of the second external device based on
a) an actual or estimated physical distance between the first external device and the second external device, the first external device and the IMD, and/or the second external device and the IMD; and/or
b) geographic location data for the first external device, the second external device, and/or the IMD; and
terminating the wireless connection between the first external device and the IMD in response to
detecting the presence of the second external device within a predetermined distance from the first external device and/or the IMD, and/or
ii) based upon the geographic location data indicating that the first external device, the second external device, and/or the IMD are located at a predetermined geographic location, See rejection of claim 1.
Consider claim 21, the method of claim 20, wherein the first external device is configured to terminate the wireless connection with the IMD:
a) directly; or
b) by transmitting a signal to the IMD that triggers the IMD to terminate the wireless connection, See rejection of claim 6.
Consider claim 24, the method of claim 20, wherein the first external device is a patient remote control device configured to be operated by a subject implanted with the IMD, and/or the second external device is a clinician programmer device configured to be operated by a medical professional, See rejection of claim 4.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Omer S. Khan whose telephone number is (571)270-5146. The examiner can normally be reached 10:00 am to 8:00 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian A. Zimmerman can be reached at 571-272-3059. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Omer S Khan/Primary Examiner, Art Unit 2686
Prosecution Insights