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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 27 - 46 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 27 is indefinite because the claim is directed to a system, but recites an active state/step of “the generated graphical representation is used prior to or during insertion of the medical device within the patient's body to enable accurate placement in a target location” (last paragraph). The claim is therefore a hybrid apparatus/method claim, which the Federal Circuit has held are indefinite under §112, second paragraph. See Rembrandt Data Techs., LP v. AOL, LLC, 641F.3d 1331, 1339 (Fed. Cir. 2011) (holding apparatus claim reciting active transmitting step indefinite). This is a critical defect because it is unclear whether the claim covers a device that is merely capable of performing the recited function or if the function must actually be performed. To overcome this rejection, examiner suggests amending the claim to recite that the representation is “configured to be” used as recited, if this is what is intended.
Claim 29 is indefinite because the claim is directed to a system, but recites an active state/step of “the single plane is used to determine a distance in a third direction”. The claim is therefore a hybrid apparatus/method claim, which the Federal Circuit has held are indefinite. It is unclear if the processor is configured to determine the distance in the third direction, or if some other meaning is intended.
Claim 30 is indefinite because the claim is directed to a system, but recites an active state/step of “the plurality of external detector devices are … used to determine a relative position of the medical device”. The claim is therefore a hybrid apparatus/method claim, which the Federal Circuit has held are indefinite. It is unclear if the processor is configured to determine the relative position of the medical device, or if some other meaning is intended.
Claim 37 is indefinite because it is unclear if “the generated graphical representation is used prior to or during insertion of the medical device within the patient's body to enable accurate placement in a target location” (last paragraph) attempts to set forth that the method includes a step of using the representation as recited, or if the language merely intends that the representation is intended to be used in the recited manner.
Claim 37 is indefinite because there is unclear antecedent basis for the “insertion of the medical device” in the last paragraph. It is unclear how the “insertion of the medical device” in the last paragraph relates to the insertion in the 3rd line. It is unclear if these are two different insertions.
Claim 45 is indefinite because it is unclear if “the single plane is used to
determine a distance in a third direction” attempts to set forth that the method includes a step of using the plane as recited, or if the language merely intends that the plane is intended to be used in the recited manner.
Claim 46 is indefinite because it is unclear if “ … and used to determine a relative position of the medical device” attempts to set forth that the method includes a step of using position detector devices as recited, or if the language merely intends that the position detector devices are intended to be used in the recited manner.
Dependent claims that are listed in the rejection header above as being rejected while not having been specifically addressed are rejected by virtue of dependency.
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 27 - 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 23 of U.S. Patent No. 11,273,288. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to systems and methods for medical device positioning, involving using a plurality of external detector devices positioned on the patient's body to interrogate one another; defining an electromagnetic three-dimensional (3D) volume based on determined distances between the detector devices; determining the patient's external and internal anatomical shape and size within the defined electromagnetic 3D volume; and generating a graphical representation of the patient's internal anatomy on the display device. In particular:
Claims 27 and 37 are suggested by reference claim 6 - 9 and/or 18 - 19. For the purpose of double patenting analysis, the limitations of the instant claims reciting “the generated graphical representation is used prior to or during insertion of the medical device within the patient's body to enable accurate placement in a target location” are interpreted as intended use that is met by the reference claims.
Claims 28 and 44 are suggested by reference claim 2 - 4 and/or 16 - 17.
Claims 29 and 45 are suggested by reference claim 16.
Claims 30 and 46 are suggested by reference claim 9 and/or 20.
Claim 31 is suggested by reference claim 7.
Claims 32 and 38 are suggested by reference claim 9 and/or 20.
Claims 27 - 32, 37 - 38, and 44 - 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 20 of U.S. Patent No. 11,944,761. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to systems and methods for medical device positioning, involving using a plurality of external detector devices positioned on the patient's body to interrogate one another; defining an electromagnetic three-dimensional (3D) volume based on determined distances between the detector devices; determining the patient's external and internal anatomical shape and size within the defined electromagnetic 3D volume; and generating a graphical representation of the patient's internal anatomy on the display device. In particular:
Claims 27 and 37 are suggested by reference claim 7 - 9 and/or 18 - 19. For the purpose of double patenting analysis, the limitations of the instant claims reciting “the generated graphical representation is used prior to or during insertion of the medical device within the patient's body to enable accurate placement in a target location” are interpreted as intended use that is met by the reference claims.
Claims 28 and 44 are suggested by reference claim 2 - 4 and/or 15.
Claims 29 and 45 are suggested by reference claim 15.
Claims 30 and 46 are suggested by reference claim 9 and/or 19.
Claim 31 is suggested by reference claim 7.
Claims 32 and 38 are suggested by reference claim 9 and/or 19.
Claims 33 - 34, 36, 39, and 43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 23 of U.S. Patent No. 11,273,288 and/or claims 1 - 20 of U.S. Patent No. 11,944,761 in view of Old et al. (US 2015/0196229).
Regarding claim 33, the reference claims fail to recite the at least one sensor comprises a first sensor and one or more second sensors, wherein the first sensor comprises a position sensor and the one or more second sensors comprises a carbon dioxide sensor, a vacuum decay sensor, a light sensor, a sound sensor, a pressure sensor, a pH sensor, a humidity sensor, a temperature sensor, or a combination thereof.
Old discloses monitoring a medical device within the GI tract. Old teaches the at least one sensor comprises a first sensor (“pill 14 can also include transmit and/or receive circuitry”, [0041]; [0046]) and one or more second sensors, wherein the first sensor comprises a position sensor (i.e., the transmit and/or receive circuitry is used to determine position) and the one or more second sensors comprises a carbon dioxide sensor, a vacuum decay sensor, a light sensor, a sound sensor, a pressure sensor, a pH sensor, a humidity sensor, a temperature sensor, or a combination thereof (“one or more additional sensors that output data, which the pill can transmit to the receiving antennas for processing by the processor. Examples of such sensors include pressure sensors, pH sensors, temperature sensors, camera(s), salinity sensors, and the like”, [0033]; [0129]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of the reference claims to include the recited features, as taught by Old, in order to facilitate diagnosing and treating GI tract pathophysiology, as suggested by Old ([0026]).
Regarding claims 34 and 39, the reference claims fail to recite interpreting, via the processor, signals obtained via the at least one sensor to instruct a display device in electronic communication with the processor to generate a real-time display of a current position and a tracing path of the medical device in conjunction with the graphical representation of the patient's internal anatomy.
Old discloses monitoring a medical device within the GI tract. Old teaches interpreting, via the processor, signals obtained via the at least one sensor to instruct a display device in electronic communication with the processor to generate a real-time display of a current position and a tracing path of the medical device in conjunction with the graphical representation of the patient's internal anatomy (“pill trajectory … shown on the display 30”, [0060]; “… see the location of the pill with respect to the patient's anatomy…,” [0120]; “display 30 may show real time location of the pill 14 with respect to human anatomy”, [0121] and fig. 10).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of the reference claims to include the recited features, as taught by Old, in order to facilitate diagnosing and treating GI tract pathophysiology, as suggested by Old ([0026]).
Regarding claims 36 and 43, the reference claims fail to recite the graphical representation of the patient's internal anatomy comprises at least one organ shape.
Old discloses monitoring a medical device within the GI tract. Old teaches the graphical representation of the patient's internal anatomy comprises at least one organ shape (see organ shapes in fig. 10).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of the reference claims to include the recited features, as taught by Old, in order to facilitate diagnosing and treating GI tract pathophysiology, as suggested by Old ([0026]).
Claims 35 and 40 - 42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 23 of U.S. Patent No. 11,273,288 and/or claims 1 - 20 of U.S. Patent No. 11,944,761 in view of Old et al. (US 2015/0196229) and Sutaria et al. (2018/0078195).
Regarding claims 35 and 40, the reference claims fail to recite interpreting when the signals of the at least one sensor indicate that the tracing path of the medical device has deviated from the patient's digestive tract; and displaying a notification or warning in response to determining that the medical device has deviated from the patient's digestive tract.
Sutaria discloses guiding medical care based on sensor data from the gastrointestinal tract. Sutaria teaches interpreting when signals of at least one sensor (acoustic sensor 104, [0138] and fig. 1C) indicate that a tracing path of a medical device has deviated from a patient's digestive tract; and displaying a notification or warning in response to determining that the medical device has deviated from the patient's digestive tract (“status indicator 401, which displays the color green to signify the tube is placed correctly …,” [0140] and fig. 4).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of the reference claims to include the recited features, as taught by Sutaria, in order to facilitate placing a feeding tube to allow the patient to receive nutrition when he/she cannot receive nutrition through the mouth, cannot swallow safely or to provide supplemental nutrition, as suggested by Sutaria ([0014]).
Regarding claim 41, the reference claims fail to recite wherein the at least one sensor comprises a first sensor and one or more second sensors, wherein the first sensor comprises a position sensor and the one or more second sensors comprises a carbon dioxide sensor, a vacuum decay sensor, a light sensor, a sound sensor, a pressure sensor, a pH sensor, a humidity sensor, a temperature sensor, or a combination thereof.
Old discloses monitoring a medical device within the GI tract. Old teaches the at least one sensor comprises a first sensor (“pill 14 can also include transmit and/or receive circuitry”, [0041]; [0046]) and one or more second sensors, wherein the first sensor comprises a position sensor (i.e., the transmit and/or receive circuitry is used to determine position) and the one or more second sensors comprises a carbon dioxide sensor, a vacuum decay sensor, a light sensor, a sound sensor, a pressure sensor, a pH sensor, a humidity sensor, a temperature sensor, or a combination thereof (“one or more additional sensors that output data, which the pill can transmit to the receiving antennas for processing by the processor. Examples of such sensors include pressure sensors, pH sensors, temperature sensors, camera(s), salinity sensors, and the like”, [0033]; [0129]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of the reference claims to include the recited features, as taught by Old, in order to facilitate diagnosing and treating GI tract pathophysiology, as suggested by Old ([0026]).
Regarding claim 42, the reference claims fail to recite interpreting the signals from the at least one sensor to confirm the position of the medical device; displaying a notification in a first warning color when the first sensor indicates that the medical device has deviated from a predetermined path; and changing the notification on the display device from the first warning color to a second warning color upon at least one sensor confirming the indication that the medical device has deviated from the predetermined path.
Sutaria discloses guiding medical care based on sensor data from the gastrointestinal tract. Sutaria teaches interpreting signals from at least one sensor (acoustic sensor 104, [0138] and fig. 1C) to confirm the position of a medical device; displaying a notification in a first warning color when the first sensor indicates that the medical device has deviated from a predetermined path; and changing the notification on the display device from the first warning color to a second warning color upon at least one sensor confirming the indication that the medical device has deviated from the predetermined path(“status indicator 401, which displays the color green to signify the tube is placed correctly … the tube is placed in the trachea or a bronchus, the status indicator 401 displays the color red,” [0140] and fig. 4).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of the reference claims to include the recited features, as taught by Sutaria, in order to facilitate placing a feeding tube to allow the patient to receive nutrition when he/she cannot receive nutrition through the mouth, cannot swallow safely or to provide supplemental nutrition, as suggested by Sutaria ([0014]).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 27 - 34, 36 - 39, and 43 - 46 are rejected under 35 U.S.C. 102(a)(1)as being anticipated by Old et al. (US 2015/0196229).
Regarding claims 27 and 37, Old shows a medical device positioning system and method of use thereof. The system comprises:
a processor (processor 22, [0037] and fig. 1);
a memory device (memory 24, [0037] and fig. 1);
a display device (display 30, [0038] and fig. 1; [0121] and fig. 10);
a medical device configured to be inserted into a patient's body (“pill 14 … antennas to transmit signals as it passes through the GI tract”, [0036] and fig. 1); and
a plurality of external detector devices (“transceiver units (TU) 16”, [0036] and fig. 1) configured to be positioned on the patient's body ([0039] and fig. 1), interrogate one another (“… transmission … from the plurality of TUs 16… non-transmitting TUs can receive the first transmitted waveform …”, [0045]; [0064]; [0068]), and send signals to the processor ([0045]), wherein each of the plurality of external detector devices comprises at least one electromagnetic emitter (transmit circuit 144, [0040] and fig. 1B) and electromagnetic receiver (receive circuit 142, [0040] and fig. 1B);
wherein the processor and the memory device are configured to:
assess the signals received from the plurality of external detector devices and determine a distance and relative angular orientation between the electromagnetic receivers of the plurality of external detector devices (“ … calculate the location of the plurality of Tus …”, [0045]; orientation of the Tus, [0062]; tracking the location of Tus, [0063]; [0064]; “… distances of the antenna k to antenna n”, [0073]; TU position vectors, [0075]);
define an electromagnetic three-dimensional (3D) volume based, at least in part on the determined distances and relative angular orientations between the electromagnetic receivers of the plurality of external detector devices (TU-centric coordinates, [0069] and coordinate system of fig. 11; antenna-centric coordinates, [0078])
determine, using one or more algorithms stored in the memory device, the patient's external and internal anatomical shape and size within the defined electromagnetic 3D volume (translate antenna-centric coordinates to body-centric coordinates, [0120]); and
generate, using one or more image processing algorithms, a graphical representation of the patient's internal anatomy on the display device, wherein the generated graphical representation is used prior to or during insertion of the medical device within the patient's body to enable accurate placement in a target location (“… see the location of the pill with respect to the patient's anatomy…,” [0120]; “display 30 may show real time location of the pill 14 with respect to human anatomy”, [0121] and fig. 10).
In the method of use, the medical device is provided and inserted; and the processor implements the algorithmic configurations.
Regarding claims 28 and 44, Old discloses the claimed invention substantially as noted above. Old further shows the plurality of external detector devices comprise a first external detector device, a second external detector device, and a third external detector device ([0036] and fig. 1).
Regarding claims 29 and 45, Old discloses the claimed invention substantially as noted above. Old further shows triangulating, via the processor, signals obtained from the plurality of external detector devices, to define the patient's upper external anatomy shape and size within the 3D volume by forming one of three points in space that define a single plane, wherein the single plane is used to determine a distance in a third direction ([0069]; triangulation, [0178]).
Regarding claims 30 and 46, Old discloses the claimed invention substantially as noted above. Old further shows the plurality of external detector devices are associated with a position detector or signal generator of the medical device (“pill 14 can also include transmit and/or receive circuitry”, [0041]; [0046]) and used to determine a relative position of the medical device (“track location of the pill with respect to the plurality of antennas”, [0035]; [0037]; “Example Pill Location Process”: [0058] - [0062]).
Regarding claim 31, Old discloses the claimed invention substantially as noted above. Old further shows the one or more algorithms define a predefined anthropometric relationship between the external anatomy and internal anatomy of the patient's body (“the patient's body … model thereof”, [0182]. Note that the model necessarily defines “a predefined anthropometric relationship between the external anatomy and internal anatomy of the patient's body”. See fig., 10 showing relationship between the external anatomy and internal anatomy of the patient's body).
Regarding claims 32 and 38, Old discloses the claimed invention substantially as noted above. Old further shows at least one sensor associated with the medical device that is configured to measure and deliver signals containing information relating to a position of the medical device (“pill 14 can also include transmit and/or receive circuitry”, [0041]; [0046]) within a patient's body to the processor via a wired or wireless electrical connection (“wirelessly output or receive wireless communication signals”, [0046]).
Regarding claim 33, Old discloses the claimed invention substantially as noted above. Old further shows the at least one sensor comprises a first sensor (“pill 14 can also include transmit and/or receive circuitry”, [0041]; [0046]) and one or more second sensors, wherein the first sensor comprises a position sensor (i.e., the transmit and/or receive circuitry is used to determine position) and the one or more second sensors comprises a carbon dioxide sensor, a vacuum decay sensor, a light sensor, a sound sensor, a pressure sensor, a pH sensor, a humidity sensor, a temperature sensor, or a combination thereof (“one or more additional sensors that output data, which the pill can transmit to the receiving antennas for processing by the processor. Examples of such sensors include pressure sensors, pH sensors, temperature sensors, camera(s), salinity sensors, and the like”, [0033]; [0129]).
Regarding claims 34 and 39, Old discloses the claimed invention substantially as noted above. Old further shows interpreting, via the processor, signals obtained via the at least one sensor to instruct a display device in electronic communication with the processor to generate a real-time display of a current position and a tracing path of the medical device in conjunction with the graphical representation of the patient's internal anatomy (“pill trajectory … shown on the display 30”, [0060]; “… see the location of the pill with respect to the patient's anatomy…,” [0120]; “display 30 may show real time location of the pill 14 with respect to human anatomy”, [0121] and fig. 10).
Regarding claims 36 and 43, Old discloses the claimed invention substantially as noted above. Old further shows the graphical representation of the patient's internal anatomy comprises at least one organ shape (see organ shapes in fig. 10).
Claim Rejections - 35 USC § 103
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.
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 35 and 40 - 42 are rejected under 35 U.S.C. 103 as being unpatentable over Old in view of Sutaria et al. (2018/0078195).
Regarding claims 35 and 40, Old discloses the claimed invention substantially as noted above.
Old fails to show interpreting when the signals of the at least one sensor indicate that the tracing path of the medical device has deviated from the patient's digestive tract; and displaying a notification or warning in response to determining that the medical device has deviated from the patient's digestive tract.
Sutaria discloses guiding medical care based on sensor data from the gastrointestinal tract. Sutaria teaches interpreting when signals of at least one sensor (acoustic sensor 104, [0138] and fig. 1C) indicate that a tracing path of a medical device has deviated from a patient's digestive tract; and displaying a notification or warning in response to determining that the medical device has deviated from the patient's digestive tract (“status indicator 401, which displays the color green to signify the tube is placed correctly …,” [0140] and fig. 4).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Old to include interpreting when the signals of the at least one sensor indicate that the tracing path of the medical device has deviated from the patient's digestive tract; and displaying a notification or warning in response to determining that the medical device has deviated from the patient's digestive tract, as taught by Sutaria, in order to facilitate placing a feeding tube to allow the patient to receive nutrition when he/she cannot receive nutrition through the mouth, cannot swallow safely or to provide supplemental nutrition, as suggested by Sutaria ([0014]).
Regarding claim 41, the combined invention of Old and Sutaria discloses the claimed invention substantially as noted above. Old further shows the at least one sensor comprises a first sensor (“pill 14 can also include transmit and/or receive circuitry”, [0041]; [0046]) and one or more second sensors, wherein the first sensor comprises a position sensor (i.e., the transmit and/or receive circuitry is used to determine position) and the one or more second sensors comprises a carbon dioxide sensor, a vacuum decay sensor, a light sensor, a sound sensor, a pressure sensor, a pH sensor, a humidity sensor, a temperature sensor, or a combination thereof (“one or more additional sensors that output data, which the pill can transmit to the receiving antennas for processing by the processor. Examples of such sensors include pressure sensors, pH sensors, temperature sensors, camera(s), salinity sensors, and the like”, [0033]; [0129]).
Regarding claim 42, Old discloses the claimed invention substantially as noted above.
Old fails to show interpreting the signals from the at least one sensor to confirm the position of the medical device; displaying a notification in a first warning color when the first sensor indicates that the medical device has deviated from a predetermined path; and changing the notification on the display device from the first warning color to a second warning color upon at least one sensor confirming the indication that the medical device has deviated from the predetermined path.
Sutaria discloses guiding medical care based on sensor data from the gastrointestinal tract. Sutaria teaches interpreting signals from at least one sensor (acoustic sensor 104, [0138] and fig. 1C) to confirm the position of a medical device; displaying a notification in a first warning color when the first sensor indicates that the medical device has deviated from a predetermined path; and changing the notification on the display device from the first warning color to a second warning color upon at least one sensor confirming the indication that the medical device has deviated from the predetermined path(“status indicator 401, which displays the color green to signify the tube is placed correctly … the tube is placed in the trachea or a bronchus, the status indicator 401 displays the color red,” [0140] and fig. 4).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Old to include interpreting the signals from the at least one sensor to confirm the position of the medical device; displaying a notification in a first warning color when the first sensor indicates that the medical device has deviated from a predetermined path; and changing the notification on the display device from the first warning color to a second warning color upon at least one sensor confirming the indication that the medical device has deviated from the predetermined path, as taught by Sutaria, in order to facilitate placing a feeding tube to allow the patient to receive nutrition when he/she cannot receive nutrition through the mouth, cannot swallow safely or to provide supplemental nutrition, as suggested by Sutaria ([0014]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIE R DAVIS whose telephone number is (571)270-7240. The examiner can normally be reached Monday-Friday, 9:30 - 6:00 PST.
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798
Prosecution Insights