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 .
Amendment Entered
In response to the amendment filed on March 2nd, 2026, amended claim 6 and new claims 57-62 are entered. Claims 11-16 are cancelled. Claims 1-10 and 57-62 are currently pending and under examination.
Response to Arguments
Applicant's remarks and amendments with respect to the claim objections have been fully considered. The objections are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the drawing objections have been fully considered. Although the objections regarding insufficient quality have been withdrawn, a new drawing objection has been made in view of the replacement drawing sheets.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections are withdrawn in view of the amendment.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 103 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.
Claim Objections
Claims 59-60 are objected to because of the following informalities:
Claim 59 recites “comprise” in line 2, but should read “comprises”
Claim 60 recites “comprise” in line 2, but should read “comprises”
Appropriate correction is required.
Drawings
The replacement drawings were received on March 2nd, 2026. These drawings are unacceptable because although the figures are now legible and of sufficient quality, the Applicant has indicated both the figures on Page 15 and Page 17 of the replacement drawings as “Figure 10A”.
Therefore, the drawings are objected to because it seems as though the Applicant has mislabeled what was supposed to be “Figure 10C” as “Figure 10A”. In order to overcome the objection, the Examiner suggests that the Applicant change the label of the figure shown on Page 17 of the drawings from “Figure 10A” to “Figure 10C”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 61 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 61 recites “a subject” in line 2. It is unclear as to whether this limitation is referring to the previously introduced “subject” from Claim 1, or a separate element.
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.
Claims 1-8, 10, 57, and 59-61 are rejected under 35 U.S.C. 103 as being unpatentable over Miyake et al (U.S. Publication No. 2024/0138731; previously cited) in view of Chiao (U.S. Publication No. 2008/0234599).
Regarding Claim 1, Miyake discloses an internal estimation system (sensor system, reader, and sensor; Abstract) comprising:
a first resonator (reader side resonant circuit 10; [0113]),
a second resonator (sensor side resonant circuit 20; [0113]; Figure 1) configured to attach to a skin surface of the subject (the sensor side resonant circuit 20 is located on the surface of the human body or inside the body. The sensor side resonant circuit 20 is, for example, provided on the surface of a living body (skin, organ, blood vessel, brain, tooth, or the like) or implanted in the body. When the object to be sensed is a biochemical substance contained in human sweat, the sensor device is exemplified by a mode such as a patch-type sensor device that is attached to the skin; [0181]), wherein the first and second resonator are resonantly coupled (The reader side resonant circuit (gain circuit) 10 and the sensor side resonant circuit (loss circuit) 20 are wirelessly connected to each other through magnetic field resonant coupling; [0127]); and
a controller (measurement device 30) connected to the first resonator and the second resonator (a measurement device 30 that measures the resistance value of the sensor element 23 in the sensor side resonant circuit 20 through the reader side resonant circuit 10; [0188]).
Although Miyake teaches a relationship between the coupling coefficient and the distance of the system (using these resonant circuits (loss circuit and gain circuit), a dissipative system (loss-loss coupling circuit) and a partially conservative system (gain-loss coupling circuit) were actually constructed, and changes in the coupling system were observed when the distance d (coupling coefficient k) between the resonant circuits was changed; [0237]; magnetic resonant coupling is mainly based on magnetic field coupling in the near field, and the coupling coefficient is a dimensionless number representing how much the magnetic field generated from a primary coil interlinks with a secondary coil. The coupling coefficient k can be defined by a vertical distance d between the coils, a horizontal displacement 1 (1 is a lower case letter of L), a tilt angle θ, a magnetic permeability μ0), and a coil radius r1, r2=13 (mm), number of turns N1, N2=1, and inductance L1, L2=32 (nH) of each resonant circuit (FIG. 5 , Formula 47 below, and Non-Patent Document 30); [0212]), Miyake fails to specifically teach a flexible tube having a first resonator, the flexible tube configured to advance into an anatomical lumen of a subject; and wherein the controller is configured to estimate a distance between the first and second resonator based on an electrical signal parameter measured by the first resonator.
In a similar technical field, Chiao teaches a passive wireless gastroesophageal sensor (Abstract), comprising a flexible tube having a first resonator, the flexible tube configured to advance into an anatomical lumen of a subject (FIG. 18A shows an array implant configuration 1800 wherein five sensors 1802 a, 1802 b, 1802 c, 1802 d and 1802 e are attached to, partially encapsulated by, or connected by a biodegradable substrate 1804 that attaches to the esophagus wall at point 1806; [0071]); wherein the controller is configured to estimate a distance between the first and second resonator based on an electrical signal parameter measured by the first resonator (FIGS. 18A and 18B illustrate various array configurations in accordance with the present invention. FIG. 18A shows an array implant configuration 1800 wherein five sensors 1802 a, 1802 b, 1802 c, 1802 d and 1802 e are attached to, partially encapsulated by, or connected by a biodegradable substrate 1804 that attaches to the esophagus wall at point 1806. The substrate 1804 degrades and breaks apart after approximately 48 hours. The sensors 1802 then pass through the GI tract and are expelled. Each sensor 1802 is on a flexible substrate, has its own resonant frequency and its own RFID to identify location. FIG. 18B shows an array implant configuration 1850 wherein a capsule 1852 is connected to four sensor electrodes 1854 a, 1854 b, 1854 c and 1854 d that are attached to, partially encapsulated by, or connected by a biodegradable substrate 1804 that attaches to the esophagus wall at point 1806. The substrate 1804 degrades and breaks apart after approximately 48 hours. The sensors electrodes 1854 then pass through the GI tract and are expelled. The metal also breaks apart and is expelled; [0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the wireless location identification teachings of Chiao into those of Miyake in order to provide an improved system that accurately monitors a patient that is more compact, untethered, improves patient comfort, and does not depend upon an implanted power source for its function (Chiao [0007]).
Regarding Claim 2, Miyake discloses wherein the electrical signal parameter is signal amplitude (As illustrated in FIG. 1 , the sensor system of the present invention is connected with a measurement device 30 that measures the resistance value of the sensor element 23 in the sensor side resonant circuit 20 through the reader side resonant circuit 10…a vector network analyzer (VNA) is used as such a measurement device and power supply device. The VNA has a function of applying a frequency sweep type signal to a connected device under test and measuring an amplitude and a phase of reflected waves and traveling waves to evaluate the frequency characteristics of the device; [0189]).
Regarding Claim 3, Miyake discloses wherein the electrical signal parameter is signal frequency (As illustrated in FIG. 1 , the sensor system of the present invention is connected with a measurement device 30 that measures the resistance value of the sensor element 23 in the sensor side resonant circuit 20 through the reader side resonant circuit 10…a vector network analyzer (VNA) is used as such a measurement device and power supply device. The VNA has a function of applying a frequency sweep type signal to a connected device under test and measuring an amplitude and a phase of reflected waves and traveling waves to evaluate the frequency characteristics of the device; [0189]).
Regarding Claim 4, Miyake discloses wherein the electrical signal parameter is signal quality (linear amplitude modulation (AM) is possible with respect to the resistance change on the sensor side, and even if the resistance change on the sensor side is weak, the reader side can obtain an amplified index of modulation. By utilizing this characteristic, it is possible to improve the sensitivity of an LCR resonator type sensor that exerts a weak resistance change in response to bio-signals or environmental changes; [0265]).
Regarding Claim 5, Miyake discloses wherein the controller is configured to estimate a parameter of content within the anatomical lumen based on the electrical signal parameter (Examples of the fluid include one or more fluids selected from the group consisting of tears, saliva, sweat, urine, feces, exhaled breath, blood, lymph, interstitial fluid, cell fluid, tissue fluid, organ fluid, and other body fluids…examples of objects to be sensed include metabolites (glucose, lactate, urea, or the like), ions (sodium, potassium, calcium, magnesium, chlorine, or the like), alcohol, stress markers (cortisol, catechol, or the like), and cancer markers (exosomes, or the like), inflammatory markers (matrix metalloproteinase, procalcitonin, ferritin, or the like), and the like; [0159-0170]; According to the present invention, for example, it is possible to wirelessly and highly sensitively measure weak signal changes from a living body (resonant circuit characteristic changes are small; in the above example, the glucose concentration in tears was demonstrated as a model). Since the biochemical components contained in tears contain many contaminants, an enzyme electrode having reaction selectivity is generally used. However, since the concentration of sugar content in tears is extremely low (0 to 1.0 (mM)), the current value obtained is only 5 to 25 (μA), and the resistance value is approximately 160 to 32 (kΩ). Measurement of glucose in tears using contact lenses (publicly known technology) is classified into enzyme sensors (Non-Patent Documents 3, 4, and 5), FET-type sensors (Non-Patent Documents 6 and 7), chemical resistors (Non-Patent Document 8), and the like; [0393-0395]).
Regarding Claim 6, Miyake discloses wherein the content comprises at least one selected from the group consisting of air content, liquid content, and solid content (Examples of the fluid include one or more fluids selected from the group consisting of tears, saliva, sweat, urine, feces, exhaled breath, blood, lymph, interstitial fluid, cell fluid, tissue fluid, organ fluid, and other body fluids. Objects to be sensed are not particularly limited, and include, for example: glucose in tears, blood, saliva, and interstitial fluid; lactate in sweat, saliva, interstitial fluid, and blood; alcohol in exhaled breath and sweat; cortisol in sweat, saliva, and tears; proteins in tears, sweat, saliva, and interstitial fluid; antibodies in tears; bacteria in saliva; adrenaline and stress substances in sweat, and the like; [0159-0169]).
Regarding Claim 7, Miyake discloses wherein the first resonator is one of a plurality of resonators (A sensor according to the present invention (not shown) is used as a part of a sensor system having a reader side resonant circuit 10 and a sensor side resonant circuit 20. The sensor includes the sensor side resonant circuit 20. Note that one reader may read a plurality of sensors, and one sensor may be read by a plurality of readers; [0115]).
Miyake fails to disclose wherein the resonators are attached to the flexible tube.
In a similar technical field, Chiao teaches a passive wireless gastroesophageal sensor (Abstract), comprising a plurality of resonators attached to the flexible tube (FIGS. 18A and 18B illustrate various array configurations in accordance with the present invention. FIG. 18A shows an array implant configuration 1800 wherein five sensors 1802 a, 1802 b, 1802 c, 1802 d and 1802 e are attached to, partially encapsulated by, or connected by a biodegradable substrate 1804 that attaches to the esophagus wall at point 1806. The substrate 1804 degrades and breaks apart after approximately 48 hours. The sensors 1802 then pass through the GI tract and are expelled. Each sensor 1802 is on a flexible substrate, has its own resonant frequency and its own RFID to identify location. FIG. 18B shows an array implant configuration 1850 wherein a capsule 1852 is connected to four sensor electrodes 1854 a, 1854 b, 1854 c and 1854 d that are attached to, partially encapsulated by, or connected by a biodegradable substrate 1804 that attaches to the esophagus wall at point 1806. The substrate 1804 degrades and breaks apart after approximately 48 hours. The sensors electrodes 1854 then pass through the GI tract and are expelled. The metal also breaks apart and is expelled; [0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the multiple resonator teachings of Chiao into those of Miyake in order to provide to wirelessly monitor the patient via multiple electrodes that pass through the GI tract (Chiao [0071]).
Regarding Claim 8, Miyake discloses wherein the second resonator (sensor side resonant circuit 20; [0113]; Figure 1) is one of a plurality of resonators (A sensor according to the present invention (not shown) is used as a part of a sensor system having a reader side resonant circuit 10 and a sensor side resonant circuit 20. The sensor includes the sensor side resonant circuit 20. Note that one reader may read a plurality of sensors, and one sensor may be read by a plurality of readers; [0115]) attached to the skin surface of the subject (the sensor side resonant circuit 20 is located on the surface of the human body or inside the body. The sensor side resonant circuit 20 is, for example, provided on the surface of a living body (skin, organ, blood vessel, brain, tooth, or the like) or implanted in the body. When the object to be sensed is a biochemical substance contained in human sweat, the sensor device is exemplified by a mode such as a patch-type sensor device that is attached to the skin; [0181]).
Regarding Claim 10, Miyake fails to disclose wherein the first resonator is attached to an outer wall of the flexible tube.
In a similar technical field, Chiao teaches a passive wireless gastroesophageal sensor (Abstract), wherein the first resonator is attached to an outer wall of the flexible tube (Figures 18A-18B; [0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the multiple resonator teachings of Chiao into those of Miyake in order to provide to wirelessly monitor the patient via multiple electrodes that pass through the GI tract (Chiao [0071]).
Regarding Claim 57, although Miyake discloses a second resonator (Miyake: sensor side resonant circuit 20; [0113]), Miyake fails to disclose wherein the resonator is planar.
In a similar technical field, Chiao teaches a passive wireless gastroesophageal sensor (Abstract), wherein the resonator is planar (Figures 18A-18B show wherein the resonators are planar).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the wireless location identification teachings of Chiao into those of Miyake in order to provide an improved system that accurately monitors a patient that is more compact, untethered, improves patient comfort, and does not depend upon an implanted power source for its function (Chiao [0007]).
Regarding Claim 59, Miyake discloses wherein at least one of the first resonator and the second resonator comprises a copper wire winding (Inductances L1 and L2 of the copper loop coil; [0204]; Figure 2).
Regarding Claim 60, Miyake discloses wherein at least one of the first resonator and the second resonator comprises a polyamide surface layer (the sensor side resonant circuit 20 is located on a surface of or inside an object. Objects include living organisms (including animals and human bodies), clothing, bedding, diapers, buildings, crops, implants, glass, food containers, and other polymeric substances; [0178]; the sensor side resonant circuit 20 is provided on the surface of polymer or glass, or embedded inside polymer or glass, for example; [0183]).
Regarding Claim 61, Miyake fails to disclose wherein the flexible tube comprises a feeding tube configured to advance into a stomach or intestine of a subject.
In a similar technical field, Chiao teaches a passive wireless gastroesophageal sensor (Abstract), wherein the flexible tube comprises a feeding tube configured to advance into a stomach or intestine of a subject (FIGS. 18A and 18B illustrate various array configurations in accordance with the present invention. FIG. 18A shows an array implant configuration 1800 wherein five sensors 1802 a, 1802 b, 1802 c, 1802 d and 1802 e are attached to, partially encapsulated by, or connected by a biodegradable substrate 1804 that attaches to the esophagus wall at point 1806. The substrate 1804 degrades and breaks apart after approximately 48 hours. The sensors 1802 then pass through the GI tract and are expelled. Each sensor 1802 is on a flexible substrate, has its own resonant frequency and its own RFID to identify location. FIG. 18B shows an array implant configuration 1850 wherein a capsule 1852 is connected to four sensor electrodes 1854 a, 1854 b, 1854 c and 1854 d that are attached to, partially encapsulated by, or connected by a biodegradable substrate 1804 that attaches to the esophagus wall at point 1806. The substrate 1804 degrades and breaks apart after approximately 48 hours. The sensors electrodes 1854 then pass through the GI tract and are expelled. The metal also breaks apart and is expelled; [0071]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the wireless location identification teachings of Chiao into those of Miyake in order to provide an improved system that accurately monitors a patient that is more compact, untethered, improves patient comfort, and does not depend upon an implanted power source for its function (Chiao [0007]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Miyake and Chiao as applied to claim 1 above, and further in view of Nagai (U.S. Publication No. 2013/0147580; previously cited).
Regarding Claim 9, although Miyake discloses a first resonator (reader side resonant circuit 10; [0113]), Miyake and Chiao fail to disclose wherein the resonator has a spiral geometry.
In a similar technical field, Nagai teaches an electromagnetic resonance coupler (Abstract), comprising a resonator that has a spiral geometry (A feature of an electromagnetic resonance coupler according to Embodiment 2 is that its transmission and reception resonators have a wound shape (spiral shape); [0180]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the spiral teachings of Nagai into those of Miyake and Chiao in order to enable highly efficient signal transmission and reduction in size (Nagai [0183]).
Claim 62 is rejected under 35 U.S.C. 103 as being unpatentable over Miyake and Chiao as applied to claim 1 above, and further in view of Zheng (U.S. Publication No. 2024/0066296).
Regarding Claim 62, Miyake and Chiao fail to specifically disclose wherein the controller is configured to estimate the distance by applying a regression model to the electrical signal parameter.
Zheng teaches an apparatus comprising multiple exterior electrodes; and means for controlling input electrical signals provided to a sub-set of the multiple exterior electrodes to control a three-dimensional location in a body of a subject where the input electrical signals combine to selectively stimulate at least first sensational receptors of the body (Abstract), wherein the controller is configured to estimate the distance by applying a regression model to the electrical signal parameter (The processing of the data, whether local or remote, may involve artificial intelligence or machine learning algorithms. The data may, for example, be used as learning input to train a machine learning network or may be used as a query input to a machine learning network, which provides a response. The machine learning network may for example use linear regression, logistic regression, vector support machines or an acyclic machine learning network such as a single or multi hidden layer neural network; [0238-0240]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the regression model teachings of Zheng into those of Miyake and Chiao in order to enable discrete outputs and continuous outputs (Zheng [0238-0240]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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/CHANEL J YOON/Examiner, Art Unit 3791
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