DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendments filed 12 November 2025 have been entered. Claims 1 - 18 are pending. Applicant’s amendments to the claims have overcome each and every objection to the specification and claims previously applied in the office action dated 18 August 2025. Applicant’s amendments have overcome each and every rejection under 35 U.S.C. 112 previously applied in the office action dated 18 August 2025.
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 14 – 15 and 18 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 14 recites the term “and the at least one sensor comprises at least two sensors”. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 14 recites the broad recitation “at least one sensor”, and the claim also recites “which comprises at least two sensors” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purposes of examination, the term “and the at least one sensor comprises at least two sensors” is deemed to claim, “and the at least one sensor comprises”. Claim 15 is similarly rejected due to its dependence on Claim 14.
Claim 14 recites the limitation “one sensor arranged at a location” in line 3. It is unclear if this is intended to be the same or different than the “at least one sensor which comprises at least two sensors” previously recited in the claim or a different sensor. For the purposes of examination, and considering the 112(b) interpretation above, the term “one sensor arranged at a location” is deemed to claim “a first sensor.” Claim 15 is similarly rejected due to its dependence on Claim 14.
Claim 18 recites the limitation "connected to the at least two sensors" in line 10. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited “at least two sensors” in the claim. For the purposes of examination, the term "connected to the at least two sensors" is deemed to claim "connected to the at least three sensors."
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 – 4, 6, and 10 – 17 are rejected under 35 U.S.C. 103 as being unpatentable over Toth et. al., (United States Patent Application Publication US 2019/0110732 A1), hereinafter Toth in view of Toth.
Regarding Claim 1, Toth Embodiment 25c discloses A disposable medical device assembly for measuring a physiological parameter in a urinary or gastrointestinal tract of a mammal being ([Abstract], [0358] “pressure”)(Examiner notes that in the absence of additional described characteristics, any catheter system, such as that disclosed by Toth, is broadly disposable.), the assembly comprising:
a probe ([0358] “implantable device”, Fig 25c) having an insertable part for insertion into a bodily opening of said mammal being (Fig 25c, section of “implantable device” within “urethra 1” and “bladder 2”), and a non-insertable part ([0359] “external tab housing 2580”; Figure 25c), said probe-including at least one sensor at a fixed position along the insertable part ([0358] “electrodes 2565 a – c” within “urethra 1”; Fig 25c) and
a control unit ([0359] “tab housing 2580) comprising an energy source connected to said at least one sensor ([0359] “tab housing 2580…may include one or more of a power source…”, “external tab housing 2580 attached to the tether 2560.”; [0358] “tether 2560 may include one or more electrodes 2565a-c”; Fig 25c)
wherein the control unit is connected to or integral with the non-insertable part of the probe ([0359] “tab housing 2580…may include one or more of a power source…”, Fig 25c, “tab housing 2580” located outside of the body, not inserted)
Toth Embodiment 25c does not disclose wherein said energy source is a biofuel cell.
Toth Embodiment 25a teaches wherein said energy source is a biofuel cell (Fig 25a, [0355] “housing 2510 may further include a power source such as…a biofuel cell”)
Toth Embodiment 25c and Toth Embodiment 25a are both implantable devices with a small housing with a power source to power sensors to measure bladder pressure that can interface with removal tethers, Toth Embodiment 25c with an interior housing mounted to the bladder wall with sensors tethered through the urethra (to accommodate additional sensors in the urethra) to a second external housing that includes a “power source”; Toth Embodiment 25a with an interior housing mounted to the bladder wall with sensors that includes a power source (biofuel cell) to power sensors and a small [0355] “tail 2530 which may function as a whip antenna for communicating 2535 with…a tether, a removal cord, etc.” Toth provides a motivation to combine at [0355] with “The housing 2510 may further include a power source such as a battery, a biofuel cell (i.e. a glucose biofuel cell, a urine based biofuel cell, etc.)…” and [0356] “…the implantable device may be configured to monitor…bladder pressures…for a period of time following a surgical procedure (i.e., days, weeks, months, indefinitely)…” A person with ordinary skill in the art would recognize that incorporating a power source such as a biofuel cell would allow for an implantable probe device to have an on-board power source for the patient’s convenience, in order to obtain bladder and urethral measurements over an extended period of time. It would have been predictable to use the biofuel cell power source in any similar implantable bladder instrumentation device with electrodes, as it would continue to operate with the function of providing power to the electronics in the bladder-inserted device.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the “power source” in the small housing for an implantable bladder measurement probe broadly-disclosed by Toth Embodiment 25c with the biofuel cell power source in the small housing for an implantable bladder measurement probe taught by Toth Embodiment 25a, creating a single bladder pressure measurement probe with an on-board biofuel power source for obtaining measurements over time for a patient with increased convenience and mobility.
Regarding Claim 2, Toth Embodiment 25c in view of Toth Embodiment 25a discloses as described above, The disposable medical device assembly of claim 1. For the remainder of Claim 2, Toth discloses further comprising an interface ([0358] “antenna”; Fig 25c) arranged to transfer measurement data from said at least one sensor to an external receiver ([0358] “…tether 2560 may include an antenna…”, “a tether 2560 for communicating 2575 with an externally placed reader…”; [0359] “…antenna…for communicating with the sensing tips included in the housing 2550”; Fig 25c)
Regarding Claim 3, Toth Embodiment 25c in view of Toth Embodiment 25a discloses as described above, The disposable medical device assembly of claim 2. For the remainder of Claim 3, Toth discloses wherein the interface ([0358] “antenna”; Fig 25c) comprises a connector ([0358] “antenna, optionally positioned within a region of the tether 2560…so as to improve the communication range thereof”; [0358] “a tether 2560 for communicating 2575 with an externally placed reader….”; Fig 25c)(Examiner notes that the “antenna” is able to communicate data from the sensors to the reader, or serve as a data connector. It is also mechanically connected on the tether) arranged to connect to a wire ([0358] “antenna, optionally position within a region of the tether 2560”, “…tether 2560 may be used to withdraw the implantable device from the subject…”)(Examiner notes that the antenna is able to communicate or connect with a “tether” removal cord, with is broadly a wire.).
Regarding Claim 4, Toth Embodiment 25c in view of Toth Embodiment 25a discloses as described above, The disposable medical device assembly of claim 2. For the remainder of Claim 4, Toth discloses wherein the interface ([0358] “antenna”; Fig 25c) is a wireless interface, and comprises a transmitter for wireless communication ([0358] “antenna, optionally positioned within a region of the tether 2560…so as to improve the communication range thereof”, “a tether 2560 for communicating 2575 with an externally placed reader….”; Fig 25c)(Examiner notes that an antenna functions as a transmitter that communicates wirelessly).
Regarding Claim 6, Toth Embodiment 25c discloses A disposable medical device assembly for measuring a physiological parameter in a urinary or gastrointestinal tract of a mammal being (Abstract, Fig 25c), the assembly comprising:
a probe ([0358] “implantable device”, Fig 25c) for insertion into a bodily opening of said mammal being (Fig 25c, section of “implantable device” within “urethra 1” and “bladder 2”), said probe including at least one sensor at a fixed position along the probe ([0358] “anchored to the wall of the bladder via a plurality of hook-like electrodes 2555a,b/2560”, “one or more electrodes 2565a-c”; Fig 25c)(Examiner notes that this set of hook-like electrodes sensors are fixed at the end of the overall probe, aligned inside the bladder.) and an energy source connected to said at least one sensor ([0359] “tab housing 2580…may include one or more of a power source…”, “external tab housing 2580 attached to the tether 2560.”; [0358] “a plurality of hook-like electrodes 2555a,b/2560”,“tether 2560 may include one or more electrodes 2565a-c”; Fig 25c)
wherein the probe is made of a biodegradable material ([0204] “a hook-like tool in accordance with the present disclosure ( e.g., with one or more sensing tips thereupon, configured as an electrode element, etc.)”, “hook may include…biodegradable structures”; [0360])(Examiner notes that part of the bill of materials that the probe is at least in part made from includes the “biodegradable structures” for the hook electrode.).
Toth Embodiment 25c does not specifically disclose wherein said energy source is a biofuel cell.
Toth Embodiment 25a teaches wherein said energy source is a biofuel cell (Fig 25a, [0355] “housing 2510 may further include a power source such as…a biofuel cell”)
The motivation for Claim 6 to combine Toth Embodiment 25c with Toth Embodiment 25a is the same as that described in more detail in Claim 1. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the “power source” in the small housing for an implantable bladder measurement probe broadly-disclosed by Toth Embodiment 25c with the biofuel cell power source in the small housing for an implantable bladder measurement probe taught by Toth Embodiment 25a, creating a single bladder pressure measurement probe with an on-board biofuel power source for obtaining measurements over time for a patient with increased convenience and mobility.
Regarding Claim 10, Toth Embodiment 25c in view of Toth Embodiment 25a discloses as described above, The disposable medical device assembly of claim 1. For the remainder of Claim 10, Toth discloses wherein the at least one sensor is at least one of a pressure sensor ([0358] “include a pressure sensing tip for monitoring bladder pressures”), a temperature sensor, a position sensor, an imaging sensor, an accelerometer, a gyroscope, a pH sensor or a flow sensor.
Regarding Claim 11, Toth Embodiment 25c in view of Toth Embodiment 25a discloses as described above, The disposable medical device assembly of claim 1. For the remainder of Claim 11, Toth discloses wherein the at least one sensor comprises at least one pressure sensor ([0358] “include a pressure sensing tip for monitoring bladder pressures”).
Regarding Claim 12, Toth Embodiment 25c in view of Toth Embodiment 25a discloses as described above, The disposable medical device assembly of claim 1. For the remainder of Claim 12, Toth discloses wherein the at least one sensor comprises a sensor arranged at a location on or adjacent to an insertable tip of the probe ([0358] “include a pressure sensing tip for monitoring bladder pressures”; Fig 25c)(Examiner notes that the “pressure sensing tip” is insertable into the bladder), and the at least one sensor is arranged on an insertable part of the probe ([0358] “the implantable device”) at a location on or proximal to said insertable tip ([0358] “the implantable device may include a pressure sensing tip for monitoring bladder pressures.”)(Examiner notes that the “pressure sensing tip” is insertable into the bladder and part of the overall“; Fig 25c),
Regarding Claim 13, Toth Embodiment 25c in view of Toth Embodiment 25a discloses as described above, The disposable medical device assembly of claim 1. For the remainder of Claim 13, Toth discloses wherein the probe ([0358] “an implantable device”; Figure 25c) is arranged for insertion into a urethra or rectum of the mammal being ([0013] “an elongate delivery member configured and dimensioned to be inserted into a bladder through a urethra…”; [0358] “…traverse the urethra 1”; Fig 25c).
Regarding Claim 14, Toth Embodiment 25c in view of Toth Embodiment 25a discloses as described above, The disposable medical device assembly of claim 1. For the remainder of Claim 14, Toth discloses wherein the probe ([0358] “an implantable device”; Figure 25c) is arranged for insertion into a urethra of the mammal being (Fig 25c; [0358] “…traverse the urethra 1”; [0013]), and the at least one sensor comprises at least two sensors (Fig 25c, [0358] “electrodes 2565 a – c”; [0358] “hook-like electrodes 2555a,b/2560”, “insertable pressure sensing tip for monitoring bladder pressures in coordination with the EMG monitoring”), one sensor arranged at a location on or adjacent to an insertable tip of the probe (Fig 25c, [0358] “implantable device may include a pressure sensing tip for monitoring bladder pressures in coordination with the EMG monitoring”), for measurement of a pressure inside a bladder (Fig 25c, [0358] “implantable device may include a pressure sensing tip for monitoring bladder pressures in coordination with the EMG monitoring”), and at least a second sensor arranged on an insertable part of the probe at a location on or proximal to said insertable tip (Fig 25c, “electrodes 2565 a – c”;[0358] “the tether 2560 may include…electrodes 2565 a – c”), for measurement of a pressure inside the urethra (Fig 25c, “electrodes 2565 a – c”; [0358] “one or more electrodes 2565 a – c for assessing electrophysiological activity within the urethra 1”).
Regarding Claim 15, Toth Embodiment 25c in view of Toth Embodiment 25a discloses as described above, The disposable medical device assembly of claim 14. For the remainder of Claim 15, Toth Embodiment 25c discloses wherein the at least the second sensor for measurement of the pressure inside the urethra (Fig 25c, “electrodes 2565a-c” in “urethra 1”) comprises one sensor arranged to measure the pressure adjacent a prostate (Fig 25c, “electrode 2565b” in “urethra 1”)(Examiner notes that “electrode 2565b” is measuring the pressure in the urethra, which is a lumen biological structure that is adjacent the prostate. Therefore, it is measuring pressure adjacent a prostate.), and one sensor arranged to measure the pressure inside the urethra (Fig 25c, “electrode 2565a” in “urethra 1”).
Regarding Claim 16, Toth Embodiment 25c in view of Toth Embodiment 25a discloses as described above, The disposable medical device assembly of claim 1. For the remainder of Claim 16, Toth Embodiment 25c does not specifically disclose further comprising a second probe, the second probe also comprising at least one sensor. Toth Embodiment 25c does disclose the probe ([0358] “implantable device”, Fig 25c) comprising at least one sensor ([0358] “electrodes 2565 a – c” within “urethra 1”; Fig 25c)(Examiner notes that Applicant’s specification describes at [0066] regarding the “additional second probe” that it allows insertion to multiple lumens of the body, “e.g., possible to use one of the probes for insertion into the urethra, and use one probe for insertion into the rectum.”
Toth Embodiment 25a teaches at [0354] “…an implantable device for monitoring and/or modulating neural activity along the wall of a hollow organ (i.e., a bladder, a uterus, a rectum, etc.). Toth Embodiment 25a and Toth Embodiment 25c are both implantable probe devices with instrumented housings that can attach to the internal wall of a hollow organ, both shown relative to the bladder in Figs. 25a and 25c.
Further, Toth overall teaches at ([0391] “a procedural tool may be placed upon a first organ (e.g. a bladder wall, a bowel wall…) and a monitoring tool may be placed upon a second organ (…a rectum…)” “a procedural tool may monitor one or more surgical locations on the first organ, perhaps in combination with monitoring performed on the second organ by the monitoring tool” and at [0365] “…the implantable devices discussing in Figs 25a-c may be configured to monitor the effect of the neuromodulating substance on the surrounding tissues over time, for following up on a surgical procedure”. ,
Toth Embodiment 25c in view of Toth Embodiment 25a discloses monitoring tool probes that can be used in multiple locations, thereby having at least a second probe, per Applicant’s definition of being able to be inserted in multiple locations. Further, Toth overall teaches a motivation that multiple monitoring tools can be used together, including a tool in the bladder and one in the rectum. A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that using a second “implantable device” would allow for simultaneous monitoring more than one location.
Based on applicability in multiple body lumens, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the “implantable device” unit disclosed by Toth Embodiment 25c for one lumen region to include a second probe device to be used in to simultaneously monitor a second region (as in Toth Embodiment 25c in view of Toth Embodiment 25a). Mere duplication of parts has no patentable significance unless a new and unexpected result is produced, see MPEP 2144.04, VI, B. Duplication of Parts.
Regarding Claim 17, Toth Embodiment 25c in view of Toth Embodiment 25a discloses as described above, The disposable medical device assembly of claim 1. For the remainder of Claim 17, Toth Embodiment 25c discloses wherein the power source ([0359] “…tab housing 2580…may include one or more of a power source…”) is arranged separately from said at least one sensor ([0359] “…tab housing 2580…may include one or more of a power source…”; Fig 25c,”tab housing” 2580 shown outside of the body, separately from “electrodes 2565 a-c” and the “sensing tips included in the housing 2550” [0359]), and wherein a conductor is provided in the probe forming a conductive path between the biofuel cell and the at least one sensor (Fig 25c; [0358] “…tether 2560 is electrically and mechanically coupled with the housing 2550…include one or more electrodes…”; [0359] “…external tab housing 2580 attached to the tether 2560…may include or more of a power source…for communicating with the sensing tips”)
Toth Embodiment 25c does not specifically disclose the biofuel cell as the power source.
Toth Embodiment 25a teaches the biofuel cell (Fig 25a, [0355] “housing 2510 may further include a power source such as…a biofuel cell”)
The motivation for Claim 17 to combine Toth Embodiment 25c with Toth Embodiment 25a is the same as that described in more detail in Claim 1. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the “power source” in the small housing for an implantable bladder measurement probe broadly-disclosed by Toth Embodiment 25c with the biofuel cell power source in the small housing for an implantable bladder measurement probe taught by Toth Embodiment 25a, creating a single bladder pressure measurement probe with an on-board biofuel power source for obtaining measurements over time for a patient with increased convenience and mobility.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Toth Embodiment 25c in view of Toth Embodiment 25a, further in view of Gellman et. al., (United States Patent Application Publication US 2004/0068203 A1), hereinafter Gellman.
Regarding Claim 5, Toth Embodiment 25c in view of Toth Embodiment 25a discloses as described above, The disposable medical device assembly of claim 2. For the remainder of Claim 5, Toth Embodiment 25c does not specifically disclose wherein the interface comprises at least one of a display and a speaker.
Gellman teaches an instrumented insertable device for measuring pressure applied to a urethra of a patient, in which the pressure sensor data is transmitted for display on a display system. Specifically for Claim 5, Gellman teaches wherein the interface comprises at least one of a display and a speaker ([0008] “…signals output by the pressure sensors can be received by a display and subsequently displayed…providing a representation of the amount of pressure represented by the signals”; [0038] …display element 57…visual or graphical notification to an operator…value of the pressure measured by the pressure sensor”).
Toth Embodiment 25c and Gellman both disclose and teach insertable instrumented urethral pressure sensor systems that can transmit sensor data external to the body. Gellman provides a motivation to combine at [0038] with “The display element 57 provides a visual or graphical notification to an operator indicating, in this embodiment, that the value of the pressure measured by the pressure sensor 41.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that having a display interface to communicate pressure information from the sensors would be useful to conveniently inform users of conditions within the lumen in which the catheter resides.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the insertable instrumented urethral pressure sensor system that can transmit sensor data external to the body disclosed in Toth Embodiment 25c with the urethral pressure data transmitted to an external display for display taught by Gellman, creating a single insertable instrumented urethral pressure sensor system that can transmit sensor data to a display for convenient review by users.
Claims 7 – 9 are rejected under 35 U.S.C. 103 as being unpatentable over Toth Embodiment 25c in view of Toth Embodiment 25a, further in view of Le Goff et. al. (United States Patent Application Publication US 2021/0249676 A1), hereinafter Le Goff.
Regarding Claim 7, Toth Embodiment 25c in view of Toth Embodiment 25a discloses as described above, The disposable medical device assembly of claim 1, wherein the biofuel cell (see citations in Claim 1).
For the remainder of Claim 7, Embodiment 25c in view of Toth Embodiment 25a does not disclose wherein the biofuel cell comprises a microbial and/or enzymatic solution, and wherein the biofuel cell is an enzymatic fuel cell.
Le Goff teaches a small button-type biocell with a biofuel reservoir that incorporates biodegradable, metal-free materials and an enzymatic solution. Specifically for Claim 7, Le Goff teaches wherein the biofuel cell ([0041] “the biofuel cell of the invention…”) comprises a microbial and/or enzymatic solution ([0012] “an anode made of…mixed with a first enzyme capable of catalyzing…”; [0013] “a cathode consisting of…mixed with a second enzyme capable of catalyzing…”), and wherein the biofuel cell is an enzymatic fuel cell ([0022] “enzyme biocell”; [0026] “an enzymatic system used at the anode…”).
The power source disclosed by Toth and Le Goff are both small biofuel cells that can use urine to produce power: Toth Embodiment 25c in view of Toth Embodiment 25a disclosing a small “biofuel cell” ([0355] “a biofuel cell (.e. a glucose biofuel cell, a urine based biofuel cell, etc.)) within the “housing 2510” of Figure 25a; Le Goff teaching a small biodegradable enzymatic “biofuel cell” with allows production of power using glucose or urine. Le Goff provides a motivation to combine at [0006] with ‘Indeed, the enzymes have a unique selectivity which allows the production of power in complex media which can allow the use of liquid and in particular of various biological fluids: sugar (glucose), sugary drinks, physiological fluids (saliva, blood, urine), of animal or vegetable origin (fruit juice) etc.) as an activator and/or fuel.“ A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that it would be useful to draw power from urine in a biofuel cell used in the urethral-inserted instrumented measurement system.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the small “biofuel cell (i.e. a glucose biofuel cell, a urine based biofuel cell)” within the “housing 2510” of Figure 25a broadly disclosed in Toth Embodiment 25c in view of Toth Embodiment 25a with the enzymatic “biofuel cell” powered by glucose or urine taught by Le Goff, creating a single insertable probe device for measuring a physiological parameter in a urinary tract, enzymatically powered by a biodegradable biofuel cell that can draw power from available liquids from the urethra. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved.
Regarding Claim 8, Toth Embodiment 25c in view of Toth Embodiment 25a discloses as described above, The disposable medical device assembly of claim 1. For the remainder of Claim 8, Toth Embodiment 25c in view of Toth Embodiment 25a discloses the biofuel cell ([0355] “a power source such as…a biofuel cell”; Fig 25a).
Toth Embodiment 25c in view of Toth Embodiment 25a does not disclose wherein the biofuel cell is made of materials comprising a biodegradable and/or compostable material, and a metal free organic material.
Specifically for the biofuel cell, Le Goff teaches a small button-type biocell with a biofuel reservoir that incorporates biodegradable, metal-free materials. Specifically for Claim 8, Le Goff teaches wherein the biofuel cell ([0041] “the biofuel cell of the invention…”) is made of materials comprising a biodegradable ([0043] “membrane can be a thin sheet…of paper…advantageously biodegradable”) and/or compostable material, and a metal free organic material ([0043] “paper”)(Examiner notes that this material is metal free, organic, and biodegradable.).
Le Goff provides a motivation to combine at [0005] “The present invention relates more particularly to the manufacture of a “button” type biocell…which can optionally be thrown away without risk for the environment.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that having an environmentally-safer biofuel source for a medical device would benefit the environment and also potentially pose less risk to patients for devices left in contact with the body. The power source disclosed by Toth and Le Goff are both small biofuel cells: Toth Embodiment 25c in view of Toth Embodiment 25a disclosing a small “biofuel cell” within the “housing 2510” of Figure 25a; Le Goff teaching a small biodegradable “biofuel cell” with paper film component.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute small “biofuel cell” within the “housing 2510” of Figure 25a broadly disclosed in Toth Embodiment 25c in view of Toth Embodiment 25a with the “biofuel cell” made of paper taught by Le Goff, creating a single insertable probe device for measuring a physiological parameter in a urinary tract, powered by a biodegradable biofuel cell that can be optionally thrown away without risk for the environment. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved.
Regarding Claim 9, Toth Embodiment 25c in view of Toth Embodiment 25a discloses as described above The disposable medical device assembly of claim 1. For the remainder of Claim 8, Toth Embodiment 25c in view of Toth Embodiment 25a discloses the biofuel cell ([0355] “a power source such as…a biofuel cell”; Fig 25a).
Toth Embodiment 25c in view of Toth Embodiment 25a does not specifically disclose wherein the biofuel cell and/or the probe is made of materials comprising a biobased material.
Le Goff teaches wherein the biofuel cell and/or the probe is made of materials comprising a biobased material ([0041] “the biofuel cell of the invention…”; [0043] “membrane can be a thin sheet…of paper…advantageously biodegradable”)(Examiner notes that Applicant’s Specification notes at [0027] that biobased is “a material wholly or partly of biogenic origin…”, which would include natural silk or paper.)
The motivation to for Claim 9 to combine Toth Embodiment 25c in view of Toth Embodiment 25a with Le Goff is similar to that described in more detail above in Claim 8. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute small “biofuel cell” within the “housing 2510” of Figure 25a broadly disclosed in Toth Embodiment 25c in view of Toth Embodiment 25a with the “biofuel cell” made of paper taught by Le Goff, creating a single insertable probe device for measuring a physiological parameter in a urinary tract, powered by a biodegradable biofuel cell that can be optionally thrown away without risk for the environment. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Shin et. al., (United States Patent Application Publication US 2023/0157603 A1) in view of Gellman et. al., (United States Patent Application Publication US 2004/0068203 A1), hereinafter Gellman.
Regarding Claim 18, Shin discloses A disposable medical device assembly for measuring a physiological parameter in a urinary or gastrointestinal tract of a mammal being ([Abstract], [0009] “catheter…a pressure sensor array…measuring bladder pressure”)(Examiner notes that in the absence of additional described characteristics, any catheter system, such as that disclosed by Shin, is broadly disposable.) the assembly comprising:
a probe for insertion into a bodily opening of said mammal being (Fig 1; [0015] “catheter inserted into bladder through urethra and prostate…a pressure sensor array installed in the catheter”), wherein the probe is configured for insertion into a urethra of the mammal being (Fig 1; [0015] “catheter inserted into bladder through urethra and prostate…a pressure sensor array installed in the catheter”);
at least three sensors coupled to the probe at fixed positions therealong (Fig 1, “bladder pressure sensor 30”, “prostate pressure sensor 40”, and “urethral pressure sensor 50”), wherein the at least three sensors include one sensor arranged at a location on or adjacent an insertable tip of the probe (Fig 1 and Fig 2, “bladder pressure sensor 30” shown near the tip of “catheter 10”; [0037] bladder pressure sensor 30 is formed on a portion of the base substrate 20 to be positioned in the bladder”) for measurement of a pressure inside a bladder ([0037] “pressure sensor array 60…measures bladder pressure.”, “pressure sensor array 60 includes…a bladder pressure sensor 30”) and a second sensor arranged on an insertable part of the probe at a location on or proximal to said tip (Fig 1 and Fig 2, “urethral pressure sensor 50” proximal to the distal tip 10, shown separated by a length of material on the “pressure sensor array 60” between “urethral pressure sensor 50” and “bladder pressure sensor 30”) for measurement of a pressure inside the urethra ([0037] “pressure sensor array 60…measure…urethral pressure.”, “pressure sensor array 60 includes…a urethral pressure sensor 50”), and a third sensor for measuring pressure adjacent a prostate ([0037] “pressure sensor array 60…measure…prostate pressure.”, “pressure sensor array 60 includes…a prostate pressure sensor 40”); and
Shin does not specifically disclose an energy source connected to the at least two [three] sensors. (Examiner notes the 112(b) interpretation above as “at least three sensors”.) However, Shin does disclose that the pressure sensors are strain gauges ([0045] “…prostate pressure sensor 40 and the urethral pressure sensor 50 are strain gauges”), and that the strain gages are connected to control circuitry ([0041] “The base substrate 20 is a printed circuit board…capable of transmitting pressure values … to an external controller through a circuit wiring 25.”, Fig 4). The presence of strain gages usually indicates that they are powered, in order to obtain a result.
For a specific teaching, Gellman teaches an instrumented catheter system with strain gage pressure sensors with wires for electrical power to measure pressure in a urethra and bladder. Specifically for Claim 18, Gellman teaches an energy source connected (Fig 1, [0037] “The wires 44 act as electrical leads to conduct electrical signals to (e.g., for providing electrical power to the sensors) and/or from (e.g., for conducting signals to a monitor or display) the pressure sensors 41a through 41h.”) to the strain gage sensors that measure pressure ([0044] “other types of sensors can be used to measure pressure…For example, resistive strain gages…”; [0007] “…plurality of pressure sensors…outputting a signal that is representative of an amount of pressure applied to the urethra at the location of that sensor”).
Shin and Gellman are both insertable instrumented urethral strain gage systems that can use wires, operating to measure pressure within the urethra. A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that using a conductive wire to pass electricity from a power source to a sensor is a common solution to delivering power to a sensor that is separate from its power source.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Shin’s disclosed “strain gauge” pressure sensor array with a wired connection with the electrical power source provided by the wiring connection to strain gages taught by Gellman, creating a single insertable medical device having a route for power between its power source and its sensors.
Response to Arguments
Applicant’s arguments with respect to claims 1 – 18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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 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.
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791