Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claim 89 is objected to because of the following informalities:
Regarding claim 89, “the” should be before “urethra” in “transportation through urethra”.
Regarding claim 90, “an” in “an powered operation device” should be changed to “a”. There should be “the” before “urinary bladder” in “through the wall of urinary bladder”.
Appropriate correction is required.
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:
In claim 90, “a powered operation device” → defined as a powered pump (see page 3, line 23)
In claim 101, “a feedback device” → defined as an implantable energy receiver having an internal first coil and a first electronic circuit connected to the first coil (see page 10, lines 8-11)
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.
Claims 95, 98, and 100 are 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 95 recites the limitations “the operating hydraulic fluid” and “the bladder operating reservoir”, however those limitations are not mentioned in claim 86. There is insufficient antecedent basis for this limitation in the claim. Claim 95 also recites the limitation “a second reservoir comprised by the apparatus”, however it is unclear what this second reservoir is.
Claim 98 recites the limitation “the implantable hydraulic fluid reservoir”, however it is not mentioned in claim 90. There is insufficient antecedent basis for this limitation in the claim.
Claim 100 recites the limitation "the implantable wireless energy receiver", however it is not mentioned in claim 86. There is insufficient antecedent basis for this limitation in the claim.
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 86-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,602,424. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-16 of US Patent 11,602,424 substantially anticipates claims 86-105 of the instant application.
See table below for corresponding teachings of reference application 16/550,315.
Instant Application
Application 16/550,315
An apparatus for treating urinary retention of a patient by assisting the discharging of urine from a natural urinary bladder, comprising:
Claim 1, lines 36-38
an expandable member, adapted to be implanted inside the natural urinary bladder of the patient, for discharging urine from the natural urinary bladder as a result of its expansion in volume,
Claim 1, lines 39-42
an implantable control device for controlling the volume of the expandable member, and
Claim 1, lines 43-44
an interconnecting device configured to connect the expandable member to the implantable control device, the interconnecting device being configured to pass through the wall of the natural urinary bladder and seal against the wall of the natural urinary bladder.
Claim 1, lines 45-49
Regarding claim 86, claim 1 of the reference application discloses all the limitations of Forsell. Claims 87-105 are similarly rejected.
Claims 86-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,390,923 in view of Barrett (US 5370690 A). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 86-105 are rendered obvious over 1-16 of US Patent 10,390,923 in view of Barrett.
See table below for corresponding teachings of reference application 15/730,781.
Instant Application
Application 15/730,781
An apparatus for treating urinary retention of a patient by assisting the discharging of urine from a natural urinary bladder, comprising:
Claim 1, lines 13-15
an expandable member, adapted to be implanted inside the natural urinary bladder of the patient, for discharging urine from the natural urinary bladder as a result of its expansion in volume,
Claim 1, lines 16-17
an implantable control device for controlling the volume of the expandable member, and
Claim 1, lines 18-19
an interconnecting device configured to connect the expandable member to the implantable control device, the interconnecting device being configured to pass through the wall of the natural urinary bladder and seal against the wall of the natural urinary bladder.
Not present
Regarding claim 86, claim 1 of the reference application teaches all limitations but fails to disclose an interconnecting device.
However, Barrett teaches an interconnecting device configured to connect the expandable member to the implantable control device, the interconnecting device being configured to pass through the wall of the natural urinary bladder and seal against the wall of the natural urinary bladder (tubing members 17, 18, 19, 20, Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention have an interconnecting device as taught by Barrett to the claim language of the reference application, the motivation being that there must be a connection between the expandable member within the urinary bladder to the control device to control its volume. Claims 87-105 are similarly rejected over 10,390,923 in view of Barrett.
Claims 86-105 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,788,928 in view of Barrett (US 5370690 A). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 86-105 are rendered obvious over 1-16 of US Patent 10,390,923 in view of Barrett.
See table below for corresponding teachings of reference application 13/123,041.
Instant Application
Application 13/123,041
An apparatus for treating urinary retention of a patient by assisting the discharging of urine from a natural urinary bladder, comprising:
Claim 1, lines 28-30
an expandable member, adapted to be implanted inside the natural urinary bladder of the patient, for discharging urine from the natural urinary bladder as a result of its expansion in volume,
Claim 1, lines 31-34
an implantable control device for controlling the volume of the expandable member, and
Claim 1, lines 35-36
an interconnecting device configured to connect the expandable member to the implantable control device, the interconnecting device being configured to pass through the wall of the natural urinary bladder and seal against the wall of the natural urinary bladder.
Not present
Regarding claim 86, claim 1 of the reference application teaches all limitations but fails to disclose an interconnecting device.
However, Barrett teaches an interconnecting device configured to connect the expandable member to the implantable control device, the interconnecting device being configured to pass through the wall of the natural urinary bladder and seal against the wall of the natural urinary bladder (tubing members 17, 18, 19, 20, Fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention have an interconnecting device as taught by Barrett to the claim language of the reference application, the motivation being that there must be a connection between the expandable member within the urinary bladder to the control device to control its volume. Claims 87-105 are similarly rejected over 10,390,923 in view of Barrett.
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 86-88, 90, 91, and 94-105 are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Barrett (US 5370690 A) in view of Forsell (US 20040172087 A1).
Regarding claim 86, Barrett teaches an apparatus for treating urinary retention of a patient by assisting the discharging of urine from a natural urinary bladder comprising (“for allowing the urine to exit the body”, abstract):
An expandable member, adapted to be implanted inside the natural urinary bladder of the patient, for discharging urine from the natural urinary bladder as a result of its expansion in volume (“the inner shell 25 is flexible and expands as urine enters the bladder 11”, Col. 2, lines 54-55; inner shell 25, shown in annotated Fig. 1 below)
An interconnecting device being configured to pass through the wall of the natural urinary bladder and seal against the wall of the natural urinary bladder (tubing members 17, 18, 19, 20, shown in annotated Fig. 1 below).
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Barrett does not teach an implantable control device and the interconnecting device connecting the expandable member to the device.
However, Forsell teaches
An implantable control device for controlling the volume of the expandable member (“control device”, paragraph [0033], “control device may include an internal control unit to be implanted in the patient”, paragraph [0035]; control unit 60, shown in annotated Fig. 8 below)
An interconnecting device configured to connect the expandable member to the implantable control, the interconnecting device being configured to pass through the wall of the natural urinary bladder and seal against the wall of the natural urinary bladder (shown in annotated Fig. 8 below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the apparatus for treating urinary retention of Barrett with the control device of Forsell, by modifying the interconnecting device of Barrett to create a connection between the expandable member and the implanted control device passing through the walls of the urinary bladder, in order to control the volume of the expandable member and assist the patient with emptying the bladder.
Regarding claim 87, Barrett in view of Forsell teaches all the limitations of claim 86.
Furthermore, Forsell teaches the control device comprising an internal control unit comprising at least one of;
An electronic circuit (“control device comprises an implantable control unit the electronic circuit thereof”, paragraph [0042])
Wherein said internal control unit is operable from the outside of the patient’s body (“control device may also, or alternatively, comprise an external control unit outside the patient’s body, preferably incorporated in the hand-held wireless remote control”, paragraph [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the apparatus of Barrett in view of Forsell and incorporate an internal control unit within the control device to power and control the device to operate within and outside the patient’s body.
Regarding claim 88, Barrett in view of Forsell teaches all the limitations of claim 86, but does not teach the first and second mating part of the control device in order to establish a detachable coupling between the expandable member and the control device through the wall of the urinary bladder.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to reasonably modify the coupling between the expandable member and the control device with detachable means, allowing for the healthcare worker to take apart various components, such as needing to replace the expandable member.
Regarding claim 90, Barrett in view of Forsell teaches the expandable member being hydraulically controlled and comprises a cavity for hydraulic fluid (“biocompatible fluid is forced into the open space from the pump the bladder inner shell collapses forcing the urine through a valve and out of the body”, Col. 2, lines 14-17; open space 27, shown in annotated Fig. 1 below);
The control device comprises an implantable bladder operating reservoir for hydraulic fluid (reservoir 12, shown in annotated Fig. 1 below), wherein
The expandable member and the control device are adapted to be hydraulically connected through the wall of the urinary bladder, wherein the control device comprises an implantable tube to establish hydraulic connection and for transporting the hydraulic fluid between the bladder operating reservoir and the cavity (“reservoir 12 causes saline to be drawn from the open space 27 in the bladder 11 through the first tubing member 17”, Col. 4, lines 21-23), and herein the control device further comprises
A powered operation device (“pumping means to enable the biocompatible fluid to flow between the bladder, reservoir and pump”, Col. 1, lines 67-68, “those skilled in the art would recognize that electrical or electromechanical pumps could also be used”, Col. 3, Col. 24-26; pump 13, shown in annotated Fig. 1 below) being adapted to transport hydraulic fluid to and from the cavity and the bladder operating reservoir, wherein the powered operation device is capable of transporting hydraulic fluid to the cavity of the expandable member to obtain a suitable urinary pressure for discharging urine (“activated pump 13 also draws saline from the reservoir 12 and forces it into the open space 27 increasing the pressure in the bladder 11 and causing the inner shell 25 to collapse. The collapsing of the inner shell 25 assures that the bladder 11 is completely emptied”, Col. 4, lines 50-55).
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Regarding claim 91, Barrett in view of Forsell teaches the expandable member being adapted to be emptied by the pressure exerted by urine of the urinary bladder (Col. 4, lines 44-55) to transport the hydraulic fluid from the cavity to the bladder operating reservoir (“the negative pressure gradient between the reservoir 12 and the bladder 11 causes saline to flow from the bladder 11 to the reservoir 12”, Col. 3, lines 32-34).
Regarding claim 94, Barrett in view of Forsell teaches at least one implantable restriction device adapted to close the ureters when discharging urine from the urinary bladder (“flow-restricting means attached to the ureter means for preventing urine from moving from the inner flexible shell”, claim 2, lines 51-53).
Regarding claim 95, Barrett in view of Forsell teaches at least one restriction device adapted to open and close the ureters being hydraulically operable by hydraulic fluid (“increased pressure in the bladder 11 requires the use of the antireflux valves 23 on the ureter tubes 16 to prevent urine from backing up into the kidneys”, Col. 4, lines 56-58; antireflux valves 23, ureter tubes 16, shown in annotated Fig. 1 below), wherein the operating hydraulic fluid is displaced to the at least one restriction device from at least one of; the bladder operating reservoir (see claim 7).
Regarding claim 96, Barrett in view of Forsell teaches all the limitations of the claim 86.
Furthermore, Forsell teaches the control device further comprising an implantable stimulating device for electrically stimulating muscles of the urinary bladder to contract the same (“stimulation device to cause the urine bladder contraction muscle to contract the bladder”, paragraph [0023]), to co-operate with the expandable member to discharge urine from the urine bladder, wherein the electrically stimulating device comprises a plurality of electrodes configured to be attached to muscles of the urinary bladder (“stimulation device suitably comprises a band for application around the urethral sphincter or bladder contraction muscle, wherein the band is provided with the electrodes for engaging the muscle”, paragraph [0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the apparatus of Barrett in view of Forsell and integrate a stimulating device for the apparatus in order to stimulate the urinary bladder muscles and help contract the muscles in the bladder when the patient needs to urinate.
Regarding claim 97, Barrett in view of Forsell teaches the expandable member being adapted to be emptied by at least one;
The pressure exerted by urine of the urinary bladder to transport the hydraulic fluid from the cavity to the bladder operating reservoir (“during bladder filling, the negative pressure in the reservoir 12 causes saline to be drawn from the open space 27 in the bladder 11 through the first tubing member 17 and into the reservoir 12”, Col. 4, lines 20-23), and the pressure exerted by urine of the urinary bladder to transport the hydraulic fluid from the cavity to the bladder operating reservoir by a second connection between the expandable member and the bladder operating reservoir (Fig. 1 shows multiple tubing members 17, 18), sized such that the pumps pumping volume capacity is significantly larger than the emptying capacity of said second connection, when open, wherein the expandable member is adapted to be emptied by the pressure exerted by urine of the urinary bladder to transport the hydraulic fluid from the cavity to the bladder operating reservoir by said second connection (“first tubing member 17…enabling saline to travel from the bladder 11 to the reservoir 12”, Col. 3, lines 27-32, “second tubing member 18…attached to the pump 13 to allow saline to flow from the reservoir 12 to the pump 13”, Col. 3, lines 42-46).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the apparatus of Barrett in view of Forsell and have more than one connection, one for delivering fluid from the reservoir to the cavity (second tubing member 18, Forsell), and one for delivering fluid from the cavity to the reservoir when the expandable member is to be emptied by the pressure exerted by urine in the bladder (first tubing member 17, Forsell).
Regarding claim 98, Barrett in view of Forsell teaches the implantable hydraulic fluid reservoir being configured to be implanted in the abdomen of the patient (“for implantation into a patient”, abstract, if the device is for the connection between the kidneys and the bladder, it must be implanted within the abdominal region), and wherein an implantable conduit is configured to connect the implantable hydraulic fluid reservoir to the implantable expandable member, passing the wall of the natural urinary bladder (first tubing member 17 shown connecting reservoir 12 to the inner shell 25 in Fig. 1).
Regarding claim 99, Barrett in view of Forsell teaches all the limitations of claim 86.
Furthermore, Forsell teaches an implantable pressure sensor connected to the implantable control device, wherein the implantable pressure sensor is configured to sense the pressure of urine in the natural urinary bladder (“the present invention may include a pressure sensor for directly or indirectly sensing the pressure in the urine bladder”, paragraph [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the apparatus of Barrett in view of Forsell and integrate a pressure sensor into the apparatus in order to determine the pressure of the urine in the bladder, in order to sense when the patient needs assistance with emptying the bladder.
Regarding claim 100, Barrett in view of Forsell teaches all the limitations of claim 86.
Furthermore, Forsell teaches an implantable sensor configured to sense a parameter related to the energy received by the implantable wireless energy receiver (“at least one implantable sensor for sensing at least one physical parameter of the patient may be provided for sending to the control device signals based on the sensed physical parameter”, paragraph [0032], “external control unit…wireless remote control…external control unit may, suitably directly, control the stimulation device in response to signals from the sensor”, paragraph [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the apparatus of Barrett in view of Forsell and integrate another implantable sensor to sense other parameters to better gauge when the patient needs assistance to urinate, such as the physical orientation of the patient (“sensor sensing that the patient is lying down”, paragraph [0035]).
Regarding claim 101, Barrett in view of Forsell teaches all the limitations of claim 86.
Furthermore, Forsell teaches a feedback device comprising an implantable feedback device (“receiving antenna 134 may be placed for example inside the abdomen…receiving antenna 134 comprises a coil”, paragraph [0093]) for sending feedback information (“generator to send digital information via the power amplifier and the antennas 132, 134 to an implanted control unit”, paragraph [0094]) being related to at least one physical parameter related to the patient (“a transceiver may be combined with the sensor 54 for sending information on the sensed physical parameter to the external control unit”, paragraph [0089]) and a functional parameter being related to the apparatus.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the apparatus of Barrett in view of Forsell and incorporate a feedback device to receive the signals of the detected physical parameters, as well as the feedback device being configured to detect functional parameters of the apparatus, such as when the pressure sensors detect the pressure within the bladder (“pressure sensor for directly or indirectly sensing the pressure in the urine bladder”, paragraph [0033]).
Regarding claim 102, Barrett in view of Forsell teaches all the limitations of claim 86.
Furthermore, Forsell teaches an external energy transmission device for wireless transmission of energy from the outside of the patient’s body to the inside of the patient’s body (“wireless remote control adapted to control the stimulation device from outside the patient’s body”, paragraph [0021]) configured to operate the expandable member and other energy consuming implantable parts of the apparatus (“remote control also controls the additional stimulation device and is operable by the patient to switch off the additional stimulation device, when the patient wants to urinate, and switch on the additional stimulation device, when the patient has finished urinating”, paragraph [0026]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the apparatus of Barrett in view of Forsell and incorporate an external energy transmission device in order to control the apparatus from the outside of the body and engage the implantable parts such as the expandable member to expand when the patient needs assistance to urinate.
Regarding claim 103, Barrett in view of Forsell teaches all the limitations of claim 86.
Furthermore, Forsell teaches a wireless remote control for noninvasively controlling the apparatus (“control device including a hand-held wireless remote control adapted to control the stimulation device from outside the patient’s body”, paragraph [0012]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the apparatus of Barrett in view of Forsell to incorporate a remote control for the patient to use, in order to control the apparatus from the outside, whenever the patient needs to urinate.
Regarding claim 104, Barrett in view of Forsell teaches all the limitations of claim 103.
Furthermore, Forsell teaches the wireless remote control transmitting at least one wireless control signal for controlling the apparatus (“the wireless remote control is suitably operable by the patient to control the stimulation device to adjust the intensity of the electric stimulation”, paragraph [0016]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the remote control would be able to transmit at least one signal to the apparatus in order to control the electric stimulation of the apparatus in order to help the patient urinate.
Regarding claim 105, Barrett in view of Forsell teaches all the limitations of claim 104.
Furthermore, Forsell teaches the wireless control signal comprising a frequency or amplitude signal or a combination thereof (“remote control may transmit a carrier signal for carrying the control signal, wherein the carrier signal is frequency, amplitude, or frequency and amplitude modulated”, paragraph [0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the apparatus of Barrett in view of Forsell to configure the wireless control signal to comprise a frequency or amplitude signal in order to have a remote connection for the control of the electric stimulation of the apparatus.
Claim 89 is rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Barrett in view of Forsell and further in view of Guiset (US 4044401 A).
Regarding claim 89, Barrett in view of Forsell teaches all the limitations of claim 86, but does not teach the expandable member being replaceable.
However, Guiset teaches the expandable member (small balloon 27, Fig. 1) being replaceable by being capable of assuming a shape (balloon shape shown in Fig. 1) admitting its transportation through the urethra (“should the small balloon 27 rupture, it is easy to replace it externally either by means of carrier forceps inserted inside the cavity 2”, Col. 6, lines 18-20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the apparatus of Barrett in view of Forsell with the replaceable expandable member of Guiset in case the expandable membrane every breaks, it can be easily replaced and inserted in the device within the patient easily.
Claim 92 is rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Barrett in view of Forsell (hereon after referred to as Forsell A) and further in view of Forsell (US 20030114729 A1) (hereon after referred to as Forsell B).
Regarding claim 92, Barrett in view of Forsell A teaches all the limitations of claim 90, but does not teach an injection port for the hydraulic fluid.
However, Forsell B teaches the operation device (“operation device is adapted to operate the hydraulic adjustment”, paragraph [0039]) comprising an injection port to calibrate the amount of hydraulic fluid in the expandable member (“an injection port may be provided for subcutaneous implantation in the patient to be in fluid communication with the chamber of the reservoir”, paragraph [0040])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the apparatus of Barrett in view of Forsell A with the operation device with the injection port of Forsell B in order to further calibrate the amount of fluid in the bladder operating reservoir.
Claim 93 is rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Barrett in view of Forsell A and further in view of Mishkin (US 5902336 A).
Regarding claim 93, Barrett in view of Forsell A teaches all the limitations of claim 90, but does not teach the hydraulic fluid comprising an agent for preventing microbial growth.
However, Mishkin teaches the hydraulic fluid comprising an agent for counteracting microbial growth, such as an antibiotic (“pump 10…having a similar static injection port…allow for injection of antibiotics”, Col. 5, lines 56-58).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the apparatus of Barrett in view of Forsell A and incorporate the injection of antibiotics of Mishkin in order to prevent the growth of bacteria within the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARA LINH TRAN whose telephone number is (571)272-3598. The examiner can normally be reached 7:30am-5:00pm M-F.
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/L.L.T./Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791