DETAILED ACTION
This Office Action is in response to Applicant’s Amendment filed on 10/02/2025.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to inventprovisions.
Specification Objection
Specification Objections as raised in Office Action dated 05/05/2025 were maintained because the instructions in “Amendment to Specification” dated 10/02/2025 to amend the specification in order to overcome specification objection raised in Office Action dated 05/05/2025, referenced paragraph numbers from the published application. Instructions to amend need to be with respect to or relative to the immediate previous/prior version or the most recent version of the specification as-filed i.e. specification dated 03/24/2021 of record and not the published specification. See MPEP 714.
The disclosure is objected to because of the following informalities:
“sufficently” and “errection” in at least [0002] of instant application specification needs to be corrected to – sufficiently-- and –er[[r]]ection--.
“artificial sphinters” in [0005] of instant application specification needs to be corrected to -- artificial sphincters--.
“the present invention insures that the patient even is continent when he or she sneezes or coughs, or performs other physical activity that causes a sudden pressure increase in the patient's bladder/urinary tract” in [0026] needs to be corrected. A suggested correction is --the present invention insures that the patient [[even]] is continent even when he or she sneezes or coughs, or performs other physical activity that causes a sudden pressure increase in the patient's bladder/urinary tract--.
The listing of references in the specification such as in for example para. [0004-0005], [0009] of instant application specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper."
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 1193-1196 under examination are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 17/210,710 (reference copending application claims dated 01/23/2026). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims merely recite the same device or essentially the same device as claimed in the reference copending application in claims 1202-1205. Furthermore, although the claims being examined are not identical, they are not patentably distinct from each other because claims 1202-1205 of copending Application No. 17/210,710 are a species of and thus, anticipate the more generic or broader claims now pending. More specifically, examined claim 1193 is substantially identical to claim 1202, examined claim 1194 is substantially identical to claim 1203, examined claim 1195 is substantially identical to claim 1204, and examined claim 1196 is substantially identical to claim 1205.
Claims 1193-1196 under examination are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application No. 17/211,874 (reference copending application claims dated 02/05/2026). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims merely recite the same device or essentially the same device as claimed in the reference copending application in claims 312-315 and thus, anticipate the claims now pending. More specifically, examined claim 1193 is substantially identical to claim 312, examined claim 1194 is substantially identical to claim 313, examined claim 1195 is substantially identical to claim 314, and examined claim 1196 is substantially identical to claim 315.
Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 U.S.C. § 103(a)
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 1193-1195 are rejected under 35 U.S.C. 103(a) as being unpatentable over Forsell, Peter (Pub. No.: US 20030144575 A1, hereinafter referred to as "Forsell") and further in view of Dlugos (Pub. No.: 2006/0211913, hereinafter referred to as " Dlugos").
As per independent Claim 1193, Forsell discloses an apparatus for controlling a flow of urine in a urethra of a patient (Forsell in at least fig. 6, fig. 34-38, fig. 45, abstract, [0001], [0009], [0013], [0015], [0019], [0078], [0125], [0128], [0146], [0158-0159], [0166-0168] for example discloses relevant subject-matter. More specifically, Forsell in at least fig. 45, abstract, [0001], [0166] for example discloses apparatus for controlling a flow of urine in a urethra 435 of a patient. See at least abstract “urinary incontinence treatment apparatus comprises an adjustable non-inflatable restriction device (434) implanted in a patient suffering from urinary incontinence. The restriction device engages the urethra (435) or urine bladder to restrict the urine passageway. An adjustment device mechanically adjusts the restriction device to restrict the urine passageway or temporarily release the urine passageway to allow the patient to urinate”), comprising:
an implantable adjustable constriction device for constricting the urethra to influence the flow in the urinary tract (Forsell in at least abstract, fig. 34, fig. 45, [0001], [0166] for example discloses an implantable adjustable constriction device 434 for constricting the urethra to influence the flow in the urinary tract. See at least Forsell [0001] “a urinary incontinence treatment apparatus for treatment of a patient, who suffers from urinary incontinence, comprising an adjustable restriction device implantable in the patient for engaging a portion of the urethra or urine bladder of the patient to restrict a urine passageway therein”);
a control device for controlling the constriction device, wherein the control device is configured to control the constriction device to constrict the urethra or to release a constriction of the urethra (Forsell in at least fig. 34, fig. 45, [0062], [0151], [0166] for example discloses a control device 338 for controlling the constriction device, wherein the control device is configured to control the constriction device to constrict the urethra or to release a constriction of the urethra. See at least Forsell [0151] “Control unit 338 comprises a demodulator and a microprocessor… microprocessor of the control unit 338 receives the digital packet, decodes it and… sends a signal via a signal line 344 to the motor 22 to either increase or decrease the size of the restriction opening of the restriction member depending on the received command code.”); and
an operation device for operating the constriction device to change the constriction of the urethra (Forsell in at least abstract, fig. 34, fig. 45, [0001], [0038], [0045], [0048], [0060], [0064], [0146], [0166] for example discloses an operation device such as a motor 22, servo means for operating the constriction device to change the constriction of the urethra . Forsell [0001] “an operable adjustment device adapted to mechanically adjust the restriction device to change the restriction of the urine passageway”; [0146] “apparatus of the invention including a motor, for instance the electric motor 22”); and
an energy source for supplying energy for the operation device (Forsell in at least abstract, fig. 34, fig. 45, [0001], [0010], [0049], [0052], [0060-0061], [0065], [0150], [0166] for example discloses an energy source 326 for supplying energy for the operation device. See at least Forsell [0150] “an implanted energiser unit 326 draws energy from the high frequency electromagnetic wave signal received by the receiving antenna 334. The energiser unit 326 stores the energy in a power supply, such as a large capacitor, powers the control unit 338 and powers the electric motor 22 via a line 342”);
Forsell does not explicitly disclose the temperature sensor features.
However, in an analogous an apparatus for controlling the flow of material through a lumen of a patient field of endeavor, Dlugos discloses an apparatus for controlling the flow of material through a lumen of a patient (Dlugos in at least fig. 2, fig. 11-12, fig. 19-20, fig. 38, abstract, [0053], [0062], [0065], [0074], [0105], [0128] for example discloses relevant subject-matter. More specifically, Dlugos in at least abstract, for example discloses apparatus for controlling the flow of material through a lumen of a patient. See at least Dlugos abstract “An implantable restriction device is configured to provide a restriction in a patient as a function of the pressure of fluid. The implantable restriction device includes one or more pressure sensors configured to sense pressure of the fluid within the implantable restriction device. Pressure data obtained by the one or more pressure sensors may be communicated to a device located external to the patient, which may process the pressure data…Where the implantable restriction device comprises an adjustable …band, the one or more pressure sensors may be located in any number of the following locations: an injection port… band… or elsewhere.”)
an implantable adjustable restriction device (Dlugos, Fig. 2) for providing a specific amount of pressure to a lumen of a patient (see Dlugos at least abstract “implantable restriction device is configured to provide a restriction in a patient as a function of the pressure of fluid. The implantable restriction device includes one or more pressure sensors configured to sense pressure of the fluid within the implantable restriction device. Pressure data obtained by the one or more pressure sensors may be communicated to a device located external to the patient, which may process the pressure data, and may further provide a display to a user including information relating to the processed pressure data. Where the implantable restriction device comprises an adjustable gastric band, the one or more pressure sensors may be located in any number of the following locations: an injection port, an interface between the injection port and a catheter, in a catheter, in-line with a catheter, adjacent to a catheter, in a gastric band, in a gastric band buckle, or elsewhere.”), wherein the restriction device includes an adjustable restriction band 38 and a port 42 (Fig. 2 and [0053], [0128]),
wherein the control device comprises a temperature sensor configured to sense a temperature of the constriction device of the apparatus or a temperature of the energy source of the apparatus (Here, the claim limitation is being interpreted broadly yet reasonably as encompassing both indirect/direct interactions, arrangement, associations, linkages, operation, functions and results. In addition, a broad yet reasonable interpretation of the optional “or” encompassing limitation “wherein the control device comprises a temperature sensor configured to sense a temperature of the constriction device of the apparatus or a temperature of the energy source of the apparatus” would also encompass the recitation -- wherein the control device comprises a temperature sensor configured to sense a temperature of the constriction device of the apparatus--. Consequently, this limitation is being broadly yet reasonably interpreted as reciting -- wherein the control device comprises a temperature sensor configured to at least indirectly sense a temperature of the constriction device of the apparatus--. Dlugos in at least abstract, fig. 11-12, fig. 19-20, fig. 38, [0062], [0065], [0074], [0105], [0128] for example discloses the control device/internal control module 132 comprises a temperature sensor 112 configured to at least indirectly sense a temperature of the constriction device of the apparatus. Examiner notes that Dlugos in at least fig. 38, abstract, [0128] discloses the implantable restriction device comprises an adjustable gastric band with one or more pressure sensors may be located in any number of the following locations: an injection port, an interface between the injection port and a catheter, in a catheter, in-line with a catheter, adjacent to a catheter, in a gastric band, in a gastric band buckle, or elsewhere and in [0074] discloses that pressure sensing systems may further comprise a temperature sensor. See at least Dlugos abstract “Where the implantable restriction device comprises an adjustable gastric band, the one or more pressure sensors may be located in any number of the following locations: an injection port, an interface between the injection port and a catheter, in a catheter, in-line with a catheter, adjacent to a catheter, in a gastric band, in a gastric band buckle, or elsewhere”; [0062] “Microcontroller 106 is integrated into a circuit board 110 within housing 94. A temperature sensor 112 measures the temperature within the implanted port and inputs a temperature signal to microcontroller 106. Microcontroller 106 uses the temperature signal from sensor 112 to compensate for variations in body temperature … Compensating the pressure measurement signal for variations in body temperature increases the accuracy of the pressure sensing system”; [0065] “internal control module 132 includes a rectifier/power regulator 160, microcontroller 106 described above, a memory 162 associated with the microcontroller, temperature sensor 112, pressure sensor 84 and a signal conditioning circuit 164 for amplifying the signal from the pressure sensor. Internal control module 132 transmits the temperature adjusted pressure measurement from pressure sensor 84 to external control module 126”; Dlugos [0074] “Additional alternative sensor systems 1088, 1188 suitable for incorporation into port 42 … Other suitable configurations will be apparent to those of ordinary skill in the art….Each of these pressure sensing systems 1088, 1118 further comprise a microcontroller 106, a TET/telemetry coil 114, and a capacitor 116. Each of these pressure sensing systems 1088 may further comprise a temperature sensor”; [0128] “a pressure sensor 500 may be located within a gastric band 502…pressure sensor 500 may be positioned within an inflatable portion of gastric band 502”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify sensor system used in the apparatus for controlling a flow of urine in a urethra of a patient as taught by Forsell, by further including a temperature sensor, as taught by Dlugos. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage [a] of using the temperature signal from sensor to compensate for variations in body temperature since compensating the pressure measurement signal for variations in body temperature increases the accuracy of the pressure sensing system (Dlugos, [0062]); and/or [b] that it may be desirable to account for temperature and other factors when considering measurements of pressure within implanted portion (Dlugos ,[0105]).
As per dependent Claim 1194, the combination of Forsell and Dlugos as a whole further discloses apparatus wherein the control device further comprises an internal signal transmitter arranged to transmit a signal based on the temperature measurements (Forsell in at least fig. 34-35, [0156] discloses that the control device further comprises an internal signal transmitter arranged to transmit a signal based on monitored measurements. Dlugos in at least abstract and [0062] for example discloses the restriction device includes a temperature sensor 112 for measuring a temperature within the implanted port, which enables compensation for variations in body temperature which could lead to inaccurate pressure sensing and transmission. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrange the signal transmitter as taught by Forsell, to transmit a signal based on temperature measurements as suggested by Dlugos. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage [a] of using the temperature signal from sensor to compensate for variations in body temperature since compensating the pressure measurement signal for variations in body temperature increases the accuracy of the pressure sensing system (Dlugos, [0062]); and/or [b] that it may be desirable to account for temperature and other factors when considering measurements of pressure within implanted portion (Dlugos ,[0105]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrange the signal transmitter as taught by Forsell, to transmit a signal a signal to an external signal receiver as disclosed by Dlugos. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage that transmission from an internal device to an external device enables receive/transmission of sensor data for subsequent change of parameters of the system as necessary (Dlugos [0065])).
As per dependent Claim 1195, the combination of Forsell and Dlugos as a whole further discloses apparatus wherein the internal signal transmitter is arranged to transmit the signal to an external signal receiver (Dlugos in at least fig. 14, [0065] for example discloses wherein the internal signal transmitter 156 is arranged to transmit the signal to an external signal receiver 144. See at least Dlugos [0065] “Coil 156 forms a tuned tank circuit that is inductively coupled with … primary telemetry coil 144 to receive and transmit data. A telemetry transceiver 158 controls data exchange with coil 156. …Internal control module 132 transmits the temperature adjusted pressure measurement from pressure sensor 84 to external control module 126”;
Claims 1196 are rejected under 35 U.S.C. 103(a) as being unpatentable over Forsell, in view of Dlugos and further in view of Hamel (Pub. No.: 2004/0113790, hereinafter referred to as "Hamel").
As per independent Claim 1196, the combination of Forsell and Dlugos as a whole further discloses apparatus according to claim 1193 (see claim 1193 above), wherein the temperature sensor is configured to measure the temperature on a regular basis (Forsell in [0156] for example disclose the control device is configured to monitor measured values on a regular basis while Dlugos in at least [0062] for example discloses the temperature sensor is configured to measure the temperature. Thus, the combination of applied art, Forsell and Dlugos as a whole discloses the limitation as now explicitly, positively and specifically recited by the Applicants. See at least Forsell [0156] “microprocessor 376 also monitors the amount of stored energy in the storage capacitor 358” and Dlugos at least [0062] “temperature sensor 112 measures the temperature within the implanted port and inputs a temperature signal to microcontroller 106. Microcontroller 106 uses the temperature signal from sensor 112 to compensate for variations in body temperature”;),
The combination of Forsell and Dlugos as a whole does not explicitly disclose control device is configured to store the measured values.
However, in an analogous electronic sensor based telemetry field of endeavor, Hamel discloses electronic telemetry system (Hamel in at least [0003], [0106-0107] for example discloses relevant subject-matter. More specifically, Hamel in at least [0003], [0106-0107] for example discloses a sensor telemetry system for remotely interrogating sensor data. See at least Hamel [0003] “a circuit for remotely powering and interrogating a sensor”),
wherein the control device is configured to store the measured values (Hamel in at least [0106-0107] for example discloses the control device is configured to store the measured values. See at least Hamel [0106] “Microprocessor 54, included in each sensor transponder 202 … instructs each transponder 202 to modulate its receiver coil to transmit sensor address and sensor data after the fixed time interval… fixed delay time number can be factory provided given the number of sensor transponders ordered or it can be reset in the field if bidirectional communication is included”; and [0107] “sensor transponder 202 can have onboard memory or data storage 208… it is possible for… sensor transponders 202 to acquire and store sensor data …Additional or alternate non-volatile data storage can also be provided, such as static RAM, magnetic RAM, or flash memory. They can then communicate the stored data back… by logging the data in data storage 208, energy is saved … If a static RAM storage device is used then battery or capacitor backup power is preferably available to retain data.”).
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 control device enabling transmission of sensor data used in the apparatus for controlling a flow of urine in a urethra of a patient as taught by Forsell as modified by Dlugos, such that control device is configured to store the measured values i.e. includes onboard storage for storing acquired, remote sensor data, as taught by Hamel. A person of ordinary skill would have been motivated to do so, with a reasonable expectation of success, for the advantage that the onboard storage enables transmission of data at later/delayed more convenient time, and additionally saves energy as compared to immediate serial transmission (Hamel, [0106-0107]).
Response to Amendment
According to the Amendment, filed 10/02/2025, the status of the claims is as follows:
Claims 1193-1194, 1196 are currently amended;
Claims 1195 are previously presented;
Claims 1198-1212 are withdrawn; and
Claims 1-1192, 1197 are cancelled.
Specification Objections as raised in Office Action dated 05/05/2025 were maintained because the instructions in “Amendment to Specification” dated 10/02/2025 to amend the specification in order to overcome specification objection raised in Office Action dated 05/05/2025, referenced paragraph numbers from the published application. Instructions to amend need to be with respect to or relative to the immediate previous/prior version or the most recent version of the specification as-filed i.e. specification dated 03/24/2021 of record and not the published specification. See MPEP 714.
By the current amendment, as a result, claims 1193-1196 are now pending in this application and are being examined on the merits as being drawn to elected invention/species.
Response to Arguments
Issues Raised and Arguments/Remarks to Rejections/Objections Not Based On Prior Art presented on Page 1-2 of Applicant’s Amendment dated 10/02/2025
[A]: The Examiner agrees with the Applicant, and in light of the amendments/arguments, withdraws the following non prior art related objections/rejections raised in Office Action dated 05/05/2025: [A1] The objection to Drawings is withdrawn in view of the amendment and arguments, filed 10/02/2025; [A2] The objection to claims is withdrawn in view of the amendment and arguments, filed 10/02/2025; [A3] The 35 U.S.C. 112 First Paragraph, rejections to claims as raised in Office Action dated 05/05/2025 are withdrawn in view of the amendment, filed 10/02/2025; [A4] The 35 U.S.C. 112 Second Paragraph, rejections to claims as raised in Office Action dated 05/05/2025 are withdrawn in view of the amendment, filed 10/02/2025.
[B]: The Examiner disagrees with the Applicant, and in light of the amendments/arguments, maintains the following non prior art related objections/rejections raised in Office Action dated 05/05/2025: [B1] Specification Objections as raised in Office Action dated 05/05/2025 were maintained because the instructions in “Amendment to Specification” dated 10/02/2025 to amend the specification in order to overcome specification objection raised in Office Action dated 05/05/2025, referenced paragraph numbers from the published application. Instructions to amend need to be with respect to or relative to the immediate previous/prior version or the most recent version of the specification as-filed i.e. specification dated 03/24/2021 of record and not the published specification. See MPEP 714.
Issues Raised and Arguments/Remarks to Double Patenting Rejections presented on Page 2 of Applicant’s Amendment dated 10/02/2025 where Applicant’s’ remarks inter alia that:
Double Patenting
[i] Applicant respectfully requests that the double patenting objections are held in abeyance until the conflicting claims have been patented.
Applicant’s request [i] above for abeyance of non-statutory obviousness-type double patenting is acknowledged. However, in the interest of clarity and thoroughness of the prosecution record, claims 1194-1196 provisional rejection on the ground of nonstatutory double patenting as being unpatentable over claims of copending Applications is being reiterated.
Issues Raised and Arguments/Remarks to Rejections Based On Prior Art presented on Pages 2-3 of Applicant’s Amendment dated 10/02/2025 where Applicant’s’ remarks inter alia that:
35 U.S.C. § 103 Rejection of the Amended Independent Claim 1193
[A] Claim 1193 iarejected under 35 U.S.C. 103(a) as being unpatentable over Forsell, Peter (Pub. No.: US 20030144575 Al, hereinafter referred to as "Forsell") and further in view of Dlugos (Pub. No.: 2006/0211913, hereinafter referred to as "Dlugos").
[B]Amended claim 1193 now specifies that the control device comprises a temperature sensor configured to sense a temperature of the constriction device of the apparatus or a temperature of the energy source of the apparatus.
[C] Dlugos is silent on a temperature sensor configured to sense a temperature of the gastric band 38, which is the implant of Dlugos. Dlugos also does not disclose that the temperature measured is the temperature of capacitor 114.
Consequently, Dlugos does not cure the deficiencies of Forsell.
[D] Claim 1193 is therefor novel and non-obvious in view of the cited art. Withdrawal of the rejection under 35 USC §103(a) is therefore respectfully requested.
Applicant’s arguments [A-D] with respect to the above claim limitation in amended independent Claim 1193 have been considered but are not persuasive.
First, with respect to Applicant’s arguments [B-C] above, please note that USPTO personnel are to give claims their broadest reasonable interpretation in light of the supporting disclosure. In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997). Limitations appearing in the specification but not recited in the claim should not be read into the claim. E-Pass Techs., Inc. v. 3Com Corp., 343 F.3d 1364, 1369, 67 USPQ2d 1947, 1950 (Fed. Cir. 2003) (claims must be interpreted "in view of the specification" without importing limitations from the specification into the claims unnecessarily). In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-551 (CCPA 1969). See also In re Zletz, 893 F.2d 319, 321-22, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989) ("During patent examination the pending claims must be interpreted as broadly as their terms reasonably allow.... The reason is simply that during patent prosecution when claims can be amended, ambiguities should be recognized, scope and breadth of language explored, and clarification imposed.... An essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process."). Consequently, the claim limitation is being interpreted broadly yet reasonably as encompassing both indirect/direct interactions, arrangement, associations, linkages, operation, functions and results. In addition, a broad yet reasonable interpretation of the optional “or” encompassing limitation “wherein the control device comprises a temperature sensor configured to sense a temperature of the constriction device of the apparatus or a temperature of the energy source of the apparatus” would also encompass the recitation -- wherein the control device comprises a temperature sensor configured to sense a temperature of the constriction device of the apparatus--. Consequently, this limitation is being broadly yet reasonably interpreted as reciting -- wherein the control device comprises a temperature sensor configured to at least indirectly sense a temperature of the constriction device of the apparatus--.
Second with respect to Applicant’s arguments [B-C] above, Dlugos in at least abstract, fig. 11-12, fig. 19-20, fig. 38, [0062], [0065], [0074], [0105], [0128] for example discloses the control device/internal control module 132 comprises a temperature sensor 112 configured to at least indirectly sense a temperature of the constriction device of the apparatus. Examiner notes that Dlugos in at least fig. 38, abstract, [0128] discloses the implantable restriction device comprises an adjustable gastric band with one or more pressure sensors may be located in any number of the following locations: an injection port, an interface between the injection port and a catheter, in a catheter, in-line with a catheter, adjacent to a catheter, in a gastric band, in a gastric band buckle, or elsewhere and in [0074] discloses that pressure sensing systems may further comprise a temperature sensor. See at least Dlugos abstract “Where the implantable restriction device comprises an adjustable gastric band, the one or more pressure sensors may be located in any number of the following locations: an injection port, an interface between the injection port and a catheter, in a catheter, in-line with a catheter, adjacent to a catheter, in a gastric band, in a gastric band buckle, or elsewhere”; [0062] “Microcontroller 106 is integrated into a circuit board 110 within housing 94. A temperature sensor 112 measures the temperature within the implanted port and inputs a temperature signal to microcontroller 106. Microcontroller 106 uses the temperature signal from sensor 112 to compensate for variations in body temperature … Compensating the pressure measurement signal for variations in body temperature increases the accuracy of the pressure sensing system”; [0065] “internal control module 132 includes a rectifier/power regulator 160, microcontroller 106 described above, a memory 162 associated with the microcontroller, temperature sensor 112, pressure sensor 84 and a signal conditioning circuit 164 for amplifying the signal from the pressure sensor. Internal control module 132 transmits the temperature adjusted pressure measurement from pressure sensor 84 to external control module 126”; Dlugos [0074] “Additional alternative sensor systems 1088, 1188 suitable for incorporation into port 42 … Other suitable configurations will be apparent to those of ordinary skill in the art….Each of these pressure sensing systems 1088, 1118 further comprise a microcontroller 106, a TET/telemetry coil 114, and a capacitor 116. Each of these pressure sensing systems 1088 may further comprise a temperature sensor”; [0128] “a pressure sensor 500 may be located within a gastric band 502…pressure sensor 500 may be positioned within an inflatable portion of gastric band 502”
For the above reasons, the 35 U.S.C. § 103 rejection of amended independent claim 1193 over the combination of the combination of Forsell and Dlugos as a whole still applies and is proper and is being maintained at this time. Please also cross-reference detailed claim 1193 interpretation, claim limitation mapping to prior art disclosed features and method steps and detailed explanations above.
Issues Raised and Arguments/Remarks to Rejections Based On Prior Art presented on Pages 10-11 of Applicant’s Amendment dated 10/02/2025 where Applicant’s’ remarks inter alia that:
35 U.S.C. § 103 Rejection of Claims 1194-1196.
[a] Claims 1194-1195, 1197 are rejected under 35 U.S.C. 103(a) as being unpatentable over Forsell, Peter (Pub. No.: US 20030144575 Al, hereinafter referred to as "Forsell") and further in view of Dlugos (Pub. No.: 2006/0211913, hereinafter referred to as "Dlugos").
[b] Consequently, Dlugos does not cure the deficiencies of Forsell. Claim 1193 is therefor novel and non-obvious in view of the cited art. Withdrawal of the rejection under 35 USC §103(a) is therefore respectfully requested.
[c] In view of the foregoing, it is believed that all of the claims pending in the application, i.e., claims 1193 – 1196, are now in condition for allowance, which action is earnestly solicited.
Applicant’s arguments with respect to dependent claims 1194-1196 been considered but are not persuasive. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the dependent claims 1194-1196 define a patentable invention based on their dependency on base claims without specifically pointing out how the language of the dependent claims patentably distinguishes them from the references.
Please also cross-reference detailed claims 1194-1196 interpretation, claim limitation mapping to prior art disclosed features and method steps and detailed explanations above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and/or the claims.
Prior art US 20050004618 A1 to Scott et al. in at least abstract and [0063] discloses implanted device wherein the control device comprises a temperature sensor configured to sense a temperature of the energy source of the apparatus similar to that claimed (See [0063] “components of control module 30 receive energy from the nonhermetic battery within power source module 32 via interconnect member 44 (FIG. 3). In some embodiments in which the nonhermetic battery is rechargeable, control module 30 receives energy inductively captured by recharge module 34 via interconnect member 46, and includes power management circuitry 70 that controls the recharging and discharging of the nonhermetic battery. Power management circuitry 70 may ensure that the nonhermetic battery is not overcharged, over-discharged, or harmed. In some embodiments, power management circuitry 70 includes circuits to measure voltages, currents or temperatures associated with the nonhermetic battery, or rates of change of these parameters, and controls recharging and discharging according to the measured values”).
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 extension fee 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 date of this final action.
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/SUNITA REDDY/Primary Examiner, Art Unit 3791