DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Claims 132-146 are 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 132 as amended requires the lifting device is “non-occluding”, and is adapted to affect the patient’s incontinence “without occluding the urethra”. Various dependent claims recite the same “non-occluding” limitation. Applicant’s original specification describes use of the lifting device for adjusting the position, or lift, of the urethra in order to treat the patient’s incontinence (pg. 13, paragraph 1). However, applicant’s original specification does not expressly state the lifting device is non-occluding or does not occlude the urethra, thus this limitation is new matter.
Claim Rejections - 35 USC § 103
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, 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 negated by the manner in which the invention was made.
Claims 132, 133, 135, and 138-141 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 6,074,341 (Anderson et al.) in view of U.S. Patent Application Publication No. 2005/0102005 (Krig et al.).
Regarding claim 132, Anderson teaches an apparatus to treat urinary incontinence in a patient (abstract; col. 1, lines 5-15; col. 4, lines 35-40; col. 9, lines 9-35), comprising at least one adjustable U-shaped lifting device (12’) adapted to lift a urethra or neck of a urine bladder, thereby affecting the patient's incontinence (Figures 4A-5B), the at least one adjustable lifting device (12’) comprising first and second fixation devices and an interconnecting part extending uninterruptedly between the first and second fixation devices (The “first and second fixation devices” are construed as the elements shown in Figures 4A-5B securing the member 12' to the pubic bone. The “interconnecting part” is construed as the portion of member 12’ extending between the securing elements as shown in Figures 4A-4B. See col. 9, lines 9-35), wherein the at least one lifting device (12’) is adapted to post-operatively and non-invasively adjust the level of lift of the urethra by changing at least one of the width and the length of the interconnecting part (The length of the member 12’ is changed to lift and lower the urethra, thus changing the distance between the urethra and each fixation position by changing a length of the "interconnecting part”. See Figures 4A-5B and col. 9, lines 8-33 and lines 36-44; col. 2, lines 60-64).
Anderson does not teach the apparatus includes a battery for powering the at least one adjustable non-occluding lifting device.
However, Anderson teaches an alternative embodiment of an apparatus to treat urinary incontinence in a patient (abstract; col. 1, lines 5-15; col. 4, lines 35-40), comprising at least one adjustable non-occluding lifting device (12) adapted to lift a urethra or neck of a urine bladder, thereby affecting the patient’s incontinence without occluding the patient’s urethra; and a battery for powering the at least one adjustable non-occluding lifting device (col. 9, line 36-44). It would have been obvious to one of ordinary skill in the art to modify the apparatus of Figures 4A-5B to be automated, thus including a battery for powering the device, as taught by Figure 6, in order to permit automated adjustment of the lifting device. Anderson teaches manual and automated adjustment of the lifting device are suitable alternative configurations.
The limitations “non-occluding” and “affecting the patient’s incontinence without occluding the urethra” are functional language. Since the lifting device of Anderson is adjustable (“can be readily programmed for different parameter settings, functions, etc.”, col. 10, lines 12-16), meaning it may be adjusted to various lengths resulting in different placements of the urethra, and consequently apply different amounts of pressure to the urethra, the lifting device of Anderson is capable of “affecting”, construed as impacting at least to some degree, the patient’s incontinence without occluding the urethra. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Anderson does not teach the apparatus further includes a first implantable sensor or measuring device configured to sense a temperature, a second implantable sensor or measuring device configured to sense the current state of the battery, and a feedback device for wirelessly sending feedback related to the sensed temperature and the sensed current state of the battery to a wireless receiver located external to the body of the patient.
However, Krig teaches a system for monitoring battery status of an implantable medical device (abstract), comprising: a battery (108) for powering the implantable medical device ([006]-[0017]); a first implantable sensor or measuring device (120) configured to sense a temperature ([0019]); a second implantable sensor or measuring device (112, 114) configured to sense the current state of the battery (108) ([0019]); and a feedback device (118) for wirelessly sending feedback related to the sensed temperature and the sensed current state of the battery to a wireless receiver (104) located external to the body of the patient ([0016]; [0019]; [0031]; Figure 1). 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 apparatus of Anderson to include the first implantable sensor or measuring device for sensing a temperature, the second implantable sensor or measuring device for sensing the current battery state, and a feedback device for wirelessly sending feedback related to the sensed temperature and current battery state to a wireless, external receiver as taught by Krig, in order to allow the user and practitioner to monitor the status of the implanted battery, its current charge, and remaining usable life (Krig: [0007]; [0017]).
Regarding claim 133, Anderson in view of Krig teaches all the limitations of claim 132. Anderson as modified teaches the feedback device (118) is further configured to wirelessly send feedback related to a transfer of energy for charging the battery (The limitation “to wirelessly sending feedback related to the transfer of energy for charging an implanted energy source” is functional language. Krig teaches the battery charge status is wirelessly sent by communication circuit 118, [0019]. The status of the battery charge is construed as “related to” energy transfer for charging an implanted energy source. Accordingly, Anderson as modified by Krig meets the functional limitation.).
Regarding claim 135, Anderson in view of Krig teaches all the limitations of claim 132. Anderson as modified teaches the feedback device (118) is further configured to wirelessly sending feedback related to an electrical parameter (Krig teaches battery status, which is an electrical parameter, is wirelessly sent, [0019]).
Regarding claims 138 and 139, Anderson in view of Krig teaches all the limitations of claim 132. Anderson as modified teaches the at least one non-occluding adjustable lifting device is mechanically regulated (col. 9, lines 8-35); and further comprises an electrical motor for mechanically regulating the at least one adjustable non-occluding lifting device (“motor” construed as driver 68, col. 9, lines 36-50; Figure 6).
Regarding claim 140, Anderson in view of Krig teaches all the limitations of claim 132. Anderson as modified teaches the adjustable non-occluding lifting device is adapted to regulate the distance between the first and second fixation devices (“first and second fixation devices” are construed as the elements shown in Figures 4A-5B securing the occlusive member 12' to the pubic bone; see col. 9, lines 9-35).
Regarding claim 141, Anderson in view of Krig teaches all the limitations of claim 132. Anderson as modified teaches a wireless energy transmitter, and wherein the adjustable non-occluding lifting device is adapted to be non-invasively regulated by the energy transmitter (Anderson: “driver 68 could be connected to externally supplied power outside the patient”, col. 9, lines 45-46; and wireless power transfer, col. 10, lines 5-12).
Claim 134 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 6,074,341 (Anderson et al.) in view of U.S. Patent Application Publication No. 2005/0102005 (Krig et al.) as applied to claim 132 above, and further in view of U.S. Patent No. 5,509,888 (Miller).
Regarding claim 134, Anderson in view of Krig teaches all the limitations of claim 132. Anderson as modified does not teach the feedback device is further configured to wirelessly send feedback related to the blood flow.
However, Miller teaches an apparatus for treating urinary incontinence (abstract; col. 1, lines 8-12), comprising: a feedback device configured to receive feedback related a blood flow (blood pressure sensor 1308, col. 5, line 63-col. 6, line 3; col. 10, lines 3-22; Figure 12). 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 apparatus of Anderson and Krig such that the feedback device is configured to receive feedback related to blood flow as taught by Miller, because Miller teaches basing opening and closing of the urethra in part on the measured blood pressure in order better meet the needs of the individual patient (col. 5, line 63-col. 6, line 3).
Claim 136 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 6,074,341 (Anderson et al.) in view of U.S. Patent Application Publication No. 2005/0102005 (Krig et al.) as applied to claim 132 above, and further in view of U.S. Patent Application Publication No. 2003/0105385 (Forsell).
Regarding claim 136, Anderson in view of Krig teaches all the limitations of claim 132. Anderson as modified does not teach the feedback device is further configured to wirelessly send feedback related to a pressure.
However, Anderson further teaches in its alternative embodiment that the device includes a sensor configured for measuring an abdominal pressure, wherein the sensed pressure is received by an implanted controller and the lifting device is adjusted based on the sensed pressure (col. 9, lines 36-67). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anderson and Krig to include the sensor for measuring pressure in order to further automate the position of the lifting device to meet the needs of the patient. Anderson as modified does not teach the feedback is further configured to wirelessly send feedback related to the pressure.
However, Forsell teaches an apparatus to treat urinary incontinence in a patient, comprising: at least one adjustable device adapted to lift the urethra or neck of the urine bladder (“restriction device”, [0001]; [0024]), thereby affecting the patient’s incontinence; a sensor for sensing a pressure (sensor implanted for sensing a physical parameter of the patient, [0051], [0098]), wherein a feedback device is configured to wirelessly send feedback related to the pressure (pressure data wirelessly sent by implanted control unit transceiver to external device: [0051]; [0098]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed inventio to modify the apparatus of Anderson and Krig to include a sensor configured to detect a pressure, wherein a feedback device is configured to wirelessly send the sensed pressure data as taught by Forsell, in order to permit the user or practitioner to monitor the pressure data and the function of the lifting device in response.
Claims 137, 142, and 143 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 6,074,341 (Anderson et al.) in view of U.S. Patent Application Publication No. 2005/0102005 (Krig et al.) as applied to claim 132 above, and further in view of U.S. Patent No. 7,395,822 (Burton et al.).
Regarding claims 137, 142, and 143, Anderson in view of Krig teaches all the limitations of claim 132. Anderson does not teach the at least one adjustable non-occluding lifting device is hydraulically regulated; the interconnecting part includes an adjustable part whose length and diameter can be adjusted to thereby adjust the level of lift of the urethra by changing the length and diameter of the adjustable part; wherein the adjustable part is a bellows which is fillable with a fluid from a reservoir so as to expand the bellows and thereby decrease the diameter and increase the length of the bellows in response to a selected amount of fluid being added to the bellows from the reservoir.
However, Burton teaches an apparatus for treating urinary incontinence in a patient (abstract), comprising: an adjustable lifting device comprising an interconnecting part (54, 55, 56) extending between first and second fixation devices (13) having an adjustable part (50) whose length and diameter can be adjusted to thereby adjust the level of lift of the urethra by changing the length and diameter of the adjustable part, wherein the adjustable part (50) is a bellows which is fillable with a fluid from a reservoir (15) so as to expand the bellows and thereby decrease the diameter and increase the length of the bellows in response to a selected amount of fluid being added to the bellows from the reservoir (col. 4, lines 26-34; col. 5, lines 1-10 and lines 39-52; Figure 5). 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 apparatus of Anderson and Krig such that the interconnecting part includes a bellows that is fillable with fluid from a reservoir to adjust its length and diameter as taught by Burton in order to allow for additional postoperative adjustment of the lifting device (Burton: col. 5, lines 1-10 and 39-52).
Claim 144 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 6,074,341 (Anderson et al.) in view of U.S. Patent Application Publication No. 2005/0102005 (Krig et al.) as applied to claim 132 above, and further in view of U.S. Patent Application Publication No. 2004/0172087 (Forsell, herein referred to as “Forsell ‘087”).
Regarding claim 144, Anderson in view of Krig teaches all the limitations of claim 132. Anderson as modified does not teach implantable electrical components including at least one voltage level guard.
However, Forsell ’087 teaches an implantable urinary incontinence device (abstract), comprising: implantable electrical components including at least one voltage level guard ([0040]). 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 apparatus of Anderson as modified to include at least one voltage level guard as taught by Forsell ‘087 in order to improve control of the “charge and discharge” of the internal battery (Forsell ‘087: [0040]).
Claim 145 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 6,074,341 (Anderson et al.) in view of U.S. Patent Application Publication No. 2005/0102005 (Krig et al.) as applied to claim 132 above, and further in view of U.S. Patent No. 4,661,107 (Fink).
Regarding claim 145, Anderson in view of Krig teaches all the limitations of claim 132. Anderson as modified does not teach the apparatus further comprises implantable electrical components including at least one constant current guard.
However, Fink teaches an implanted medical device (abstract), comprising implantable electrical components including at least one constant current guard (“constant current guard” construed as current limiter 39, col. 3, lines 44-59; Figure 6). 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 apparatus of Anderson as modified to include a constant current guard as taught by Fink in order to prevent overcharging the battery, as is “well known in the art” (Fink, col. 3, lines 44-47).
Claim 146 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 6,074,341 (Anderson et al.) in view of U.S. Patent Application Publication No. 2005/0102005 (Krig et al.) as applied to claim 132 above, and further in view of U.S. Patent No. 5,876,425 (Gord).
Regarding claim 146, Anderson in view of Krig teaches all the limitations of claim 132. Anderson as modified does not teach the apparatus further comprises a control device for controlling the transmission of wireless energy from an energy-transmission device, and an implantable internal energy receiver for receiving the transmitted wireless energy, the internal energy receiver being connected to implantable energy consuming components of the apparatus for directly or indirectly supplying received energy thereto, the apparatus further comprising a determination device adapted to determine an energy balance between the energy received by the internal energy receiver and the energy used for the implantable energy consuming components of the apparatus, and wherein the control device controls the transmission of wireless energy from the external energy-transmission device, based on the energy balance determined by the determination device.
However, Gord teaches an implantable medical device (abstract), comprising
a control device (30) for controlling the transmission of wireless energy from an energy-transmission device (34), and
an implantable internal energy receiver (40) for receiving the transmitted wireless energy, the internal energy receiver being connected to implantable energy consuming components (48 and internal components) of the apparatus for directly or indirectly supplying received energy thereto,
the apparatus further comprising a determination device (32, 42, 46) adapted to determine an energy balance between the energy received by the internal energy receiver and the energy used for the implantable energy consuming components (48 and internal components) of the apparatus, and
wherein the control device (30) controls the transmission of wireless energy from the external energy-transmission device, based on the energy balance determined by the determination device (col. 6, lines 15-45; col. 9, line 12-col. 10, line 61; Figures 1A and 2). 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 apparatus of Anderson and Krig to include the control device, implantable internal energy receiver, energy-transmission device, external energy transmission device, and determination device as taught by Gord in order to provide a power control loop to non-invasively transmit power when needed to increase the battery life (Gord: col. 3, line 62-col. 4, line 17).
Response to Arguments
Applicant’s arguments, see page 5, filed 8 December 2025, with respect to the rejections under 35 U.S.C. 112(b) have been fully considered and are persuasive in light of the amendments to the claims. The rejections of 10 June 2025 have been withdrawn.
Applicant's arguments filed 8 December 2025 with respect to the rejections under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant contends Anderson fails to disclose a non-occluding lifting device as required in the amended claims, as Anderson is “completely focused on the occlusion of the urethra” (arguments, page 6). The examiner does not find this argument to be persuasive. The limitations “non-occluding” and “affecting the patient’s incontinence without occluding the urethra” are functional language. Anderson discloses a lifting device that may be selectively adjusted to “different parameter settings, functions, etc.” before and after implantation (col. 10, lines 12-16). Since the lifting device of Anderson is adjustable, meaning it may be adjusted to various lengths resulting in different placements of the urethra, and consequently apply different amounts of pressure to the urethra, the lifting device of Anderson is capable of “affecting”, construed as impacting at least to some degree, the patient’s incontinence without occluding the urethra. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Conclusion
Applicant's amendment necessitated any 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 Carrie R Dorna whose telephone number is (571)270-7483. The examiner can normally be reached 8am-5pm.
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/CARRIE R DORNA/Primary Examiner, Art Unit 3791