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 .
Status of Claims
Applicant's arguments, filed 12/16/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 12/16/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 1-4, 6-7, 11, 13-15, and 18-19.
Applicants have canceled/previously canceled claims 5 and 16.
Applicants have left claims 8-10, 12, 17, and 20 as originally filed/previously presented.
Claims 1-4, 6-15, and 17-20 are the current claims hereby under examination.
Claim Warnings - Withdrawn
Applicant’s arguments, see page 7 of Remarks, filed 12/16/2025, with respect to the claim warning have been fully considered and are persuasive. Applicants have amended the claims, rendering the claim warning moot. The claim warning has been withdrawn.
Claim Objections - Withdrawn and Newly Applied Necessitated by Applicant’s Amendments
Claim 6 is objected to because of the following informalities:
Regarding claim 6, lines 3-4 recite “a predefined threshold”, however it appears it should read --the predefined threshold-- (emphasis added).
Response to Arguments
Applicant’s arguments, see page 7 of Remarks, filed 12/16/2025, with respect to claims 2-7, 11, 13-16, and 19 have been fully considered and are persuasive. Applicants have amended the claims, rendering the objections moot. The objections of claims 2-7, 11, 13-16, and 19 have been withdrawn. However, Applicants amendments necessitated new claim objections.
Claim Rejections - 35 USC § 112(a) - Newly Applied Necessitated by Applicant’s Amendments
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2-4 and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 2-4, clam 1 recites “computing … a peak value of acceleration … identifying … a location of the ingestible device … by comparing the peak value ….”, claim 2 recites “further comprises determining a range of the acceleration measurements during the given period of time”, claim 3 recites “further comprises identifying the location of the ingestible device … in response to the range of the acceleration measurements …”, and claim 4 recites “further comprises identifying the location of the ingestible device … in response to the range of the acceleration measurements”. That is, claim 1 recites using a peak value of acceleration to identify a location, and claims 2-4 further recite using a range of the acceleration measurements to identifying the location. However, the specification does not reasonably convey to one skilled in the art the inventor or a joint inventor, had possession of the claimed invention.
Regarding claim 15, claim 14 recites “compute a peak value of acceleration … identifies the location of the ingestible device … in response to the peak value …”, and claim 15 recites “determines a range of the acceleration measurements … identifies the location of the ingestible device … in response to the range of the acceleration …”. That is, claim 14 recites using a peak value of acceleration to identify a location, and claim 15 further recites using a range of the acceleration measurements to identifying the location. However, the specification does not reasonably convey to one skilled in the art the inventor or a joint inventor, had possession of the claimed invention.
The specification recites in para. 45-46, “in one example, a peak value of acceleration will differ amongst the different regions of the gastrointestinal tract …”, “in another example … acceleration spread is higher in the small intestine than the stomach or in the large intestine”, and “a metric derived from the acceleration measurements (e.g., range or peak value) is continually computed and compared …”. Para. 53 also includes typical results of the spread and peak acceleration. That is, while the specification does recite separate embodiments of using a peak value or a range, the specification does not reasonably convey a single embodiment utilizing both the range and the peak value, along with what the distinct thresholds are.
Claim Rejections - 35 USC § 112(b) - Withdrawn and Newly Applied Necessitated by Applicant’s Amendments
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 3-4, 11, and 15 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.
Regarding claim 3, the claim recites “identifying the location of the ingestible device … in response to the range of the acceleration measurements exceeding a threshold”. However, claim 1 recites “identifying … a location of the ingestible device … by comparing the peak value of acceleration to a predefined threshold”. In light of the specification, it is currently unclear if “a threshold” recited in claim 3 is the same as, related to, or different from “a predefined threshold” in claim 1. The specification generically recites in para. 46-47 thresholds are used to identify the location, but does not explicitly differentiate between the range and peak value. For the purposes of examination, “a threshold” recited in claim 3 is being interpreted as any threshold related to the acceleration measurements.
The dependent claims of the above rejected claim are rejected due to their dependency.
Regarding claim 11, the claim recites the limitation "the metric" in line 4 and line 7. There is insufficient antecedent basis for this limitation in the claim. In light of the specification, it is currently unclear if “the metric” is referring to “a peak value of acceleration from the acceleration measurements, or a different metric. The specification recites in para. 45 a metric can be a peak value of acceleration or an acceleration spread. For the purposes of examination, “the metric”, recited in claim 11 is being interpreted as “the peak value of acceleration of the acceleration measurements”.
Regarding claim 15, the claim recites “identifies the location of the ingestible device … in response to the range of the acceleration measurements exceeding a threshold”. However, claim 14 recites “identifies the location of the ingestible device … in response to the peak value of acceleration measurements exceeding a predefined threshold”. In light of the specification, it is currently unclear if “a threshold” recited in claim 15 is the same as, related to, or different from “a predefined threshold” in claim 14. The specification generically recites in para. 46-47 thresholds are used to identify the location, but does not explicitly differentiate between the range and peak value. For the purposes of examination, “a threshold” recited in claim 15 is being interpreted as any threshold related to the acceleration measurements.
Regarding claim 15, the claim recites “identifies the location of the ingestible device … in response to the range of the acceleration measurements being less than a second threshold”. However, claim 14 recites “identifies the location of the ingestible device … in response to the peak value of acceleration measurements being less than a second predefined threshold”. In light of the specification, it is currently unclear if “a second threshold” recited in claim 15 is the same as, related to, or different from “a second predefined threshold” in claim 14. The specification generically recites in para. 46-47 thresholds are used to identify the location, but does not explicitly differentiate between the range and peak value. For the purposes of examination, “a second threshold” recited in claim 15 is being interpreted as any threshold related to the acceleration measurements.
Response to Arguments
Applicant’s arguments, see page 7 of Remarks, filed 12/16/2025, with respect to claims 18-19 have been fully considered and are persuasive. Applicants have amended the claims, rendering the rejection moot. The 112(b) rejection of claims 18-19 has been withdrawn. However, Applicant’s amendments necessitated new rejections.
Claim Rejections - 35 USC § 102 - Withdrawn
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Response to Arguments
Applicant’s arguments, see pages 7-8 of Remarks, filed 12/16/2025, with respect to the rejection(s) of claim(s) 1-7 and 15-16 under 35 USC 102 have been fully considered and are persuasive. Applicants have amended the claims to recite “a predefined threshold”. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Chang et al. (US 20130015976 A1).
Claim Rejections - 35 USC § 103 - Newly Applied Necessitated by Applicant’s Amendments
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, 6-7, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Yehuda et al. (US 20240115326 A1) (previously cited), hereinafter referred to as Yehuda, in view of Chang et al. (US 20130015976 A1), hereinafter referred to as Chang.
The claims are generally directed towards a method for tracking an ingestible device in a gastrointestinal tract of a subject, comprising: measuring, by an accelerometer disposed in the ingestible device, acceleration of the ingestible device as it traverses through the gastrointestinal tract; computing, by a processor, a peak value of acceleration from the acceleration measurements obtained by the accelerometer over a given period of time; and identifying, by the processor, a location of the ingestible device in the gastrointestinal tract by comparing the peak value of acceleration to a predefined threshold.
Regarding claim 1, Yehuda discloses a method for tracking an ingestible device in a gastrointestinal tract of a subject (Abstract, “ingestible in-vivo gastrointestinal device … a sensor … determine a location of the in-vivo gastrointestinal device …”, para. [0006], para. [0012], para. [0030]), comprising:
measuring, by an accelerometer disposed in the ingestible device, acceleration of the ingestible device as it traverses through the gastrointestinal tract (para. [0037-0039], “ingestible IGVD has at least one on-board sensor … 3-axial inertial sensor incorporating one or more of a triaxial accelerometer …”, para. [0042], “detecting the location of the IVGD …”, para. [0050-0053]);
computing, by a processor, a peak value of acceleration from the acceleration measurements obtained by the accelerometer over a given period of time (para. [0030], “IVGD with an internal processor and a sensor to determine the location of the IVGD …”, para. [0042], “processor to determine the location … IVGD will output an acceleration from the internal sensor dominantly in the Z axis …”, para. [0050-0053], “processor software continues to monitor the inertial sensor outputs … inertial sensor provides X, Y and Z outputs … dominant sequential Z acceleration …” - the peak value being related to the dominant Z acceleration); and
identifying, by the processor, a location of the ingestible device in the gastrointestinal tract by comparing the peak value of acceleration to a threshold (para. [0037-0039], para. [0042], para. [0050-0053], “as long as the inertial sensor outputs continue to indicate dominant single axis movement … IVGD is determined to be in the small intestine … IVGD transitions from the small intestine to the large intestine, a 3 axis movement beings … inertial sensor outputs do not continue to indicate dominant single axis movement … indication that the IVGD is in the large intestine” - the threshold being the indication of the dominant Z acceleration).
However, Yehuda does not explicitly disclose the comparing of the peak value of acceleration is to a predefined threshold.
Chang teaches an analogous system and method of monitoring and tracking movement through the use of an accelerometer (Abstract, para. [0003], para. [0030], para. [0037]). Chang teaches measuring an acceleration, computing a peak value of acceleration over a given period of time, and identifying a result by comparing the peak value of acceleration to a predefined threshold (para. [0085], “detect extrema of various different time-domain features and then analyzes the sequence of x, y, and z extrema and their properties (e.g., acceleration amplitude) with heurist rules to look for state transitions … match a pattern associated with a known transition …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Yehuda to explicitly compare the peak value of acceleration to a predefined threshold to identify the location, as taught by Chang. This is because Chang teaches comparing to pre-defined thresholds through rule-based monitoring is a known method of analyzing accelerometer data to determine specific movements (para. [0038], para. [0146]).
Regarding claim 2, modified Yehuda discloses the method of claim 1 further comprises determining a range of the acceleration measurements during the given period of time (para. [0050-0053], “output of the inertial sensor are dominantly indicative of motion in the Z axis … provides X, Y and Z outputs … continues to read outputs of the inertial sensor … dominant sequential Z acceleration, which continues for at least a predetermined time, e.g., for a minimum of 10 seconds … a dominant single axis movement begins … lasts few hours …” - a range of acceleration measurements being the X, Y and Z outputs and/or a range of acceleration measurements being the outputs being provided by the sensor over the period of time).
Regarding claim 3, modified Yehuda discloses the method of claim 2 further comprises identifying the location of the ingestible device in the gastrointestinal tract as small intestine in response to the range of the acceleration measurements exceeding a threshold (para. [0050-0053], “dominant sequential Z acceleration, which continues for at least a predetermined time … indicates that the IVGD has left the stomach and is now in the small intestines …” - the threshold being the indication of a dominant Z acceleration).
Regarding claim 4, modified Yehuda discloses the method of claim 3 further comprises identifying the location of the ingestible device in the gastrointestinal tract as large intestine in response to the range of the acceleration measurements being less than a second threshold (para. [0050-0053], “IVGD transitions from the small intestine to the large intestine, a 3 axis movement begins, i.e. the inertial sensor outputs do not continue to indicate dominant signal axis movement …” - “a second threshold” is being interpreted as being an amplitude threshold of the acceleration different from “a threshold” recited in claim 3. The second threshold being the lack of a dominant Z threshold over the period of time).
Regarding claim 6, modified Yehuda discloses the method of claim 1 further comprises identifying the location of the ingestible device in the gastrointestinal tract as small intestine in response to the peak value of the acceleration measurements exceeding a predefined threshold (para. [0050-0053], “dominant sequential Z acceleration, which continues for at least a predetermined time … indicates that the IVGD has left the stomach and is now in the small intestines …” - the threshold being the indication of a dominant Z acceleration. Further, see the rejection of claim 1 regarding the predefined threshold).
Regarding claim 7, modified Yehuda discloses the method of claim 6 further comprises identifying the location of the ingestible device in the gastrointestinal tract as large intestine in response to the peak value of the acceleration measurements being less than a second threshold (para. [0032], “located in the … large intestine, i.e., will not be confined to single axis motion …”, para. [0050-0053], “IVGD transitions from the small intestine to the large intestine, a 3 axis movement begins, i.e. the inertial sensor outputs do not continue to indicate dominant signal axis movement … Once the IVGD has reached the large intestine, the outputs of the inertial sensor will be randomly of X, Y, and Z, which is an indication that the IVGD is in the large intestine … ” - “a second threshold” is being interpreted as being an amplitude threshold of the acceleration different from “a predefined threshold” recited in claim 6. The IVGD is identified as being located within the large intestine when the outputs are randomly of X, Y, and Z. That is, the Z axis acceleration is no longer dominant, or the Z axis is below a second threshold because the X, Y, and Z are now random due to not being confined).
Regarding claim 14, Yehuda discloses an ingestible device for traversing a gastrointestinal tract (Abstract, “ingestible in-vivo gastrointestinal device … a sensor … determine a location of the in-vivo gastrointestinal device …”, Fig. 2A, para. [0006], para. [0030]), comprising:
a housing configured to be ingested by a subject (Fig. 2A, element 201, para. [0030], “ingestible device, such as a capsule …”, para. [0032], “oval element (a plastic capsule)”);
an accelerometer disposed inside the housing and operable to measure acceleration of the ingestible device as it traverses through the gastrointestinal tract of the subject (Fig. 2A, element 204, para. [0037-0039], “ingestible IGVD has at least one on-board sensor … 3-axial inertial sensor incorporating one or more of a triaxial accelerometer …”, para. [0042], “detecting the location of the IVGD …”, para. [0050-0053]); and
a microcontroller residing in the housing and interfaced with the accelerometer (Fig. 2A, elements 203 and 204, para. [0030], para. [0042]), wherein the microcontroller is configured to compute a peak value of acceleration from the acceleration measurements obtained by the accelerometer over a period of time (para. [0030], “IVGD with an internal processor and a sensor to determine the location of the IVGD …”, para. [0042], “processor to determine the location … IVGD will output an acceleration from the internal sensor dominantly in the Z axis …”, para. [0050-0053], “processor software continues to monitor the inertial sensor outputs … dominant single axis movement beings, which lasts few hours … randomly of X, Y and Z …”) identifies the location of the ingestible device in the gastrointestinal tract as small intestine in response to the peak value of acceleration measurements exceeding a threshold (para. [0050-0053], “dominant sequential Z acceleration, which continues for at least a predetermined time … indicates that the IVGD has left the stomach and is now in the small intestines …” - the threshold being the indication of a dominant Z acceleration); and identifies the location of the ingestible device in the gastrointestinal tract as large intestine in response to the peak value of acceleration measurements being less than a second threshold (para. [0032], “located in the … large intestine, i.e., will not be confined to single axis motion …”, para. [0050-0053], “IVGD transitions from the small intestine to the large intestine, a 3 axis movement begins, i.e. the inertial sensor outputs do not continue to indicate dominant signal axis movement … Once the IVGD has reached the large intestine, the outputs of the inertial sensor will be randomly of X, Y, and Z, which is an indication that the IVGD is in the large intestine … ” - “a second threshold” is being interpreted as being an amplitude threshold of the acceleration different from “a predefined threshold” recited in claim 6. The IVGD is identified as being located within the large intestine when the outputs are randomly of X, Y, and Z. That is, the Z axis acceleration is no longer dominant, or the Z axis is below a second threshold because the X, Y, and Z are now random due to not being confined).
However, Yehuda does not explicitly disclose the thresholds are a predefined threshold and a second predefined threshold.
Chang teaches an analogous system and method of monitoring and tracking movement through the use of an accelerometer (Abstract, para. [0003], para. [0030], para. [0037]). Chang teaches measuring an acceleration, computing a peak value of acceleration over a period of time, and identifying a result by comparing the peak value of acceleration to a predefined threshold (para. [0085], “detect extrema of various different time-domain features and then analyzes the sequence of x, y, and z extrema and their properties (e.g., acceleration amplitude) with heurist rules to look for state transitions … match a pattern associated with a known transition …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Yehuda to explicitly compare the peak value of acceleration to predefined thresholds to determine the location, as taught by Chang. This is because Chang teaches comparing to pre-defined thresholds through rule-based monitoring is a known method of analyzing accelerometer data to determine specific movements (para. [0038], para. [0146]).
Regarding claim 15, modified Yehuda discloses the ingestible device of claim 14 wherein the microcontroller determines a range of the acceleration measurements during the period of time (para. [0050-0053], “output of the inertial sensor are dominantly indicative of motion in the Z axis … provides X, Y and Z outputs … continues to read outputs of the inertial sensor … dominant sequential Z acceleration, which continues for at least a predetermined time, e.g., for a minimum of 10 seconds … a dominant single axis movement begins … lasts few hours …” - a range of acceleration measurements being the X, Y and Z outputs and/or a range of acceleration measurements being the outputs being provided by the sensor over the period of time); identifies the location of the ingestible device in the gastrointestinal tract as small intestine in response to the range of the acceleration measurements exceeding a threshold (para. [0050-0053], “dominant sequential Z acceleration, which continues for at least a predetermined time … indicates that the IVGD has left the stomach and is now in the small intestines …” - the threshold being the indication of a dominant Z acceleration); and identifies the location of the ingestible device in the gastrointestinal tract as large intestine in response to the range of the acceleration measurements being less than a second threshold (para. [0032], “located in the … large intestine, i.e., will not be confined to single axis motion …”, para. [0050-0053], “IVGD transitions from the small intestine to the large intestine, a 3 axis movement begins, i.e. the inertial sensor outputs do not continue to indicate dominant signal axis movement … Once the IVGD has reached the large intestine, the outputs of the inertial sensor will be randomly of X, Y, and Z, which is an indication that the IVGD is in the large intestine … ” - “a second threshold” is being interpreted as being an amplitude threshold of the acceleration different from “a threshold” recited above. The IVGD is identified as being located within the large intestine when the outputs are randomly of X, Y, and Z. That is, the Z axis acceleration is no longer dominant, or the Z axis is below a second threshold because the X, Y, and Z are now random due to not being confined).
Claims 8-12 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yehuda et al. (US 20240115326 A1) (previously cited), hereinafter referred to as Yehuda, in view of Chang et al. (US 20130015976 A1), hereinafter referred to as Chang, as applied to claims 1 and 14 above, and further in view of Jones et al. (US 20180279908 A1) (previously cited), hereinafter referred to as Jones.
Regarding claim 8, modified Yehuda discloses the method of claim 1.
However, Yehuda suggests, but does not explicitly disclose further comprises collecting a sample from the gastrointestinal tract using the ingestible device and tagging the sample with the location in the gastrointestinal tract at which the sample was collected. Yehuda suggests this because at paras. [0003] – [0004] and [0031] it is described where intestine diagnostics using capsules are used for a wide variety of medical applications and performing medical procedures that need to be carried out at a specific location and requires identification of said location.
Jones teaches a method of using an analogous ingestible device and determining the location of the ingestible device within a GI tract (Abstract, para. [0004]). Jones further teaches collecting a sample from the gastrointestinal tract using the ingestible device and tagging the sample with the location in the gastrointestinal tract at which the sample was collected (para. [0038], para. [0040], para. [0082], para. [0155], para. [0188]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by modified Yehuda to additionally collect a sample from the gastrointestinal tract using the ingestible device and tag the sample with the location in the gastrointestinal tract at which the sample was collected as taught by Jones. This is because Jones teaches collecting a sample and tagging the location allows for certain medical conditions to be detected based on the sample and location (para. [0155]). Further, modified Yehuda teaches enabling the IVGD to take an action such as performing a medical procedure, wherein collecting a sample falls within the scope of medical procedures. Therefore, one of ordinary skill in the art would have been capable of applying this known method of enhancement to the “base” method (device or product) in the prior art and the results would have been predictable.
Regarding claim 9, modified Yehuda discloses the method of claim 1.
However, Yehuda suggests, but does not explicitly disclose further comprises determining when the ingestible device passes through a particular location in the gastrointestinal tract and releasing a substance from the ingestible device while at the particular location. Yehuda suggests this because at paras. [0003-0004] and [0031] it is described where intestine diagnostics using capsules are used for a wide variety of medical applications and performing medical procedures that need to be carried out at a specific location and requires identification of said location.
Jones teaches a method of using an analogous ingestible device and determining the location of the ingestible device within a GI tract (Abstract, para. [0004]). Jones further teaches determining when the ingestible device passes through a particular location in the gastrointestinal tract and releasing a substance from the ingestible device while at the particular location (para. [0039-0040], para. [0075], para. [0156]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by modified Yehuda to additionally determine when the ingestible device passes through a particular location in the gastrointestinal tract and release a substance from the ingestible device while at the particular location as taught by Jones. This is because Jones teaches determining the location of the device and releasing a substance allows for the device to deliver therapeutics and medicaments at targeted locations within the GI tract (para. [0156]). Further, modified Yehuda teaches enabling the IVGD to take an action such as performing a medical procedure, wherein releasing medication falls within the scope of medical procedures. Therefore, one of ordinary skill in the art would have been capable of applying this known method of enhancement to the “base” method (device or product) in the prior art and the results would have been predictable.
Regarding claim 10, modified Yehuda discloses the method of claim 1.
However, Yehuda does not explicitly disclose further comprises wirelessly communicating the location in the gastrointestinal tract to another device outside of the gastrointestinal tract.
Jones teaches a method of using an analogous ingestible device and determining the location of the ingestible device within a GI tract (Abstract, para. [0004]). Jones further teaches wirelessly communicating the location in the gastrointestinal tract to another device outside of the gastrointestinal tract (para. [0188]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by modified Yehuda to additionally wirelessly communicate the location in the gastrointestinal tract to another device outside of the gastrointestinal tract as taught by Jones. This is because Jones teaches transmitting the location to another device outside of the gastrointestinal tract allows for a physician to analyze all of the data about the subject to provide recommendations (para. [0188]).
Regarding claim 11, modified Yehuda discloses the method of claim 1.
However, Yehuda does not explicitly disclose further comprises wirelessly communicating the acceleration measurements to another device outside of the gastrointestinal tract; computing, by the processor, the metric from the acceleration measurements obtained by the accelerometer over the given period of time; and identifying, by the processor, the location in the gastrointestinal tract based in part on the metric, where the processor resides in the another device.
Jones teaches a method of using an analogous ingestible device and determining the location of the ingestible device within a GI tract (Abstract, para. [0004]). Jones further teaches wirelessly communicating data indicative of location to another device outside of the gastrointestinal tract; computing, by the processor, the metric from the data indicative of location over the given period of time; and identifying, by the processor, the location in the gastrointestinal tract based in part on the metric, where the processor resides in the another device (Fig. 16, para. [0007], para. [0185-0186], para. [0188]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by modified Yehuda to additionally wirelessly communicate the acceleration measurements to another device outside of the gastrointestinal tract; compute, by the processor, the metric from the acceleration measurements obtained by the accelerometer over the given period of time; and identify, by the processor, the location in the gastrointestinal tract based in part on the metric, where the processor resides in the another device as taught by Jones. This is because Jones teaches transmitting data from the device to an external processor allows for the external processor to perform the analytics data, which one of ordinary skill in the art would recognize allows the device to preserve the battery life by offloading computation (para. [0188]).
Regarding claim 12, modified Yehuda discloses the method of claim 1.
However, Yehuda suggests, but does not explicitly disclose further comprises monitoring elapsed time from when the ingestible device entered the gastrointestinal tract; and tagging the location in the gastrointestinal tract with an elapsed time at which the ingestible device enters the location in the gastrointestinal tract. Yehuda suggests this because at paras. [0048], [0053], and [0060], it is described the IVGD will remain within different portions of the gastrointestinal tract for certain durations, and the IVGD is tagged as being within the different portions of the gastrointestinal tract.
Jones teaches a method of using an analogous ingestible device and determining the location of the ingestible device within a GI tract (Abstract, para. [0004]). Jones further teaches monitoring elapsed time from when the ingestible device entered the gastrointestinal tract; and tagging the location in the gastrointestinal tract with an elapsed time at which the ingestible device enters the location in the gastrointestinal tract (Fig. 7, Fig. 8, para. [0138-0143]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by modified Yehuda to additionally monitor the elapsed time from when the ingestible device entered the gastrointestinal tract; and tag the location in the gastrointestinal tract with an elapsed time at which the ingestible device enters the location in the gastrointestinal tract as taught by Jones. This is because Jones teaches monitoring the elapsed time and the transition times between different locations in the gastrointestinal tract allows for a physician to analyze the data to provide recommendations (para. [0188]).
Regarding claim 17, modified Yehuda discloses the ingestible device of claim 14.
However, modified Yehuda does not explicitly disclose further comprises a wireless transceiver interface with the microcontroller and wirelessly communicates the location in the gastrointestinal tract to another device located outside of the gastrointestinal tract.
Jones teaches an analogous ingestible device and determining the location of the ingestible device within a GI tract (Abstract, para. [0004]). Jones further teaches wirelessly communicating the location in the gastrointestinal tract to another device outside of the gastrointestinal tract (para. [0188]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ingestible device disclosed by modified Yehuda to additionally include a wireless transceiver interface with the microcontroller and wirelessly communicates the location in the gastrointestinal tract to another device located outside of the gastrointestinal tract as taught by Jones. This is because Jones teaches transmitting the location to another device outside of the gastrointestinal tract allows for a physician to analyze all of the data about the subject to provide recommendations (para. [0188]).
Regarding claim 18, modified Yehuda discloses the ingestible device of claim 14.
However, modified Yehuda does not explicitly disclose the ingestible device further comprises a cap connected to the housing and comprising a surface defining a sampling port; one or more sample collection chambers within the housing and configured to collect gastric-intestinal samples; a rotatable shaft disposed within the housing and is configured to rotate one of the cap or the one or more sample collection chambers; and a motor connected to the rotatable shaft within the housing and configured to axially rotate the rotatable shaft; wherein the microcontroller is configured to control the motor and rotatable shaft so as to selectively align the sampling port of the cap with at least one of the sample collection chambers, thereby exposing the at least one sample collection chamber to the gastric-intestinal tract for collection of one or more gastrointestinal fluid samples.
Jones teaches an analogous ingestible device and determining the location of the ingestible device within a GI tract (Abstract, para. [0004]). Jones further teaches the ingestible device comprises a cap connected to the housing (Fig. 2, element 106, para. [0079]) and comprising a surface defining a sampling port (Fig. 2, element 110, element 116, para. [0079], para. [0081]); one or more sample collection chambers within the housing and configured to collect gastric-intestinal samples (Fig. 2, element 118-3, para. [0082]); a rotatable shaft disposed within the housing and is configured to rotate one of the cap or the one or more sample collection chambers (Fig. 2, element 118, para. [0082]); and a motor connected to the rotatable shaft within the housing and configured to axially rotate the rotatable shaft (Fig. 2, element 118-1, para. [0082]); wherein the microcontroller is configured to control the motor and rotatable shaft so as to selectively align the sampling port of the cap with at least one of the sample collection chambers, thereby exposing the at least one sample collection chamber to the gastric-intestinal tract for collection of one or more gastrointestinal fluid samples (para. [0082]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ingestible device disclosed by modified Yehuda to additionally include a cap connected to the housing and comprising a surface defining a sampling port; one or more sample collection chambers within the housing and configured to collect gastric-intestinal samples; a rotatable shaft disposed within the housing and is configured to rotate one of the cap or the one or more sample collection chambers; and a motor connected to the rotatable shaft within the housing and configured to axially rotate the rotatable shaft; wherein the microcontroller is configured to control the motor and rotatable shaft so as to selectively align the sampling port of the cap with at least one of the sample collection chambers, thereby exposing the at least one sample collection chamber to the gastric-intestinal tract for collection of one or more gastrointestinal fluid samples as taught by Jones. This is because Jones teaches a sampling port in communication with a rotatable shaft and at least one sample collection chamber allows for the ingestible device to obtain fluid samples and/or provide medication to a user when the ingestible device is located in a desired location (para. [0082], para. [0155-0156]).
Regarding claim 19, modified Yehuda discloses the ingestible device of claim 18.
However, modified Yehuda suggests, but does not explicitly disclose wherein the microcontroller operates to collect the gastric-intestinal samples and tag the samples with the location in the gastrointestinal tract at which the sample was collected. Yehuda suggests this because at paras. [0003] – [0004] and [0031] it is described where intestine diagnostics using capsules are used for a wide variety of medical applications and performing medical procedures that need to be carried out at a specific location and requires identification of said location.
Jones further teaches collecting gastric-intestinal samples and tagging the samples with the location in the gastrointestinal tract at which the sample was collected (para. [0038], para. [0040], para. [0082], para. [0155], para. [0188]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ingestible device disclosed by modified Yehuda to additionally include collecting gastric-intestinal samples and tagging the samples with the location in the gastrointestinal tract at which the sample was collected, as taught by Jones. This is because Jones teaches collecting a sample and tagging the location allows for certain medical conditions to be detected based on the sample and location (para. [0155]). Further, Yehuda teaches enabling the IVGD to take an action such as performing a medical procedure, wherein collecting a sample falls within the scope of medical procedures. Therefore, one of ordinary skill in the art would have been capable of applying this known method of enhancement to the “base” method (device or product) in the prior art and the results would have been predictable.
Regarding claim 20, modified Yehuda discloses the ingestible device of claim 14.
However, Yehuda suggests, but does not explicitly disclose wherein the microcontroller monitors elapsed time from when the ingestible device entered the gastrointestinal tract; and tags the location in the gastrointestinal tract with an elapsed time at which the ingestible device enters the location in the gastrointestinal tract. Yehuda suggests this because at paras. [0048], [0053], and [0060], it is described the IVGD will remain within different portions of the gastrointestinal tract for certain durations, and the IVGD is tagged as being within the different portions of the gastrointestinal tract.
Jones teaches an analogous ingestible device and determining the location of the ingestible device within a GI tract (Abstract, para. [0004]). Jones further teaches a microcontroller monitors elapsed time from when the ingestible device entered the gastrointestinal tract; and tags the location in the gastrointestinal tract with an elapsed time at which the ingestible device enters the location in the gastrointestinal tract (Fig. 7, Fig. 8, para. [0138-0143]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ingestible device disclosed by modified Yehuda to additionally monitor elapsed time from when the ingestible device entered the gastrointestinal tract; and tag the location in the gastrointestinal tract with an elapsed time at which the ingestible device enters the location in the gastrointestinal tract as taught by Jones. This is because Jones teaches monitoring the elapsed time and the transition times between different locations in the gastrointestinal tract allows for a physician to analyze the data to provide recommendations (para. [0188]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Yehuda et al. (US 20240115326 A1) (previously cited), hereinafter referred to as Yehuda, in view of Chang et al. (US 20130015976 A1), hereinafter referred to as Chang, in view of Jones et al. (US 20180279908 A1) (previously cited), hereinafter referred to as Jones.
Regarding claim 13, Yehuda discloses a method for tracking an ingestible device in a gastrointestinal tract of a subject (Abstract, “ingestible in-vivo gastrointestinal device … a sensor … determine a location of the in-vivo gastrointestinal device …”, para. [0006], para. [0012], para. [0030]), comprising:
measuring, by an accelerometer disposed in the ingestible device, acceleration of the ingestible device as it traverses through the gastrointestinal tract (para. [0037-0039], “ingestible IGVD has at least one on-board sensor … 3-axial inertial sensor incorporating one or more of a triaxial accelerometer …”, para. [0042], “detecting the location of the IVGD …”, para. [0050-0053]);
computing, by a processor, a peak value of acceleration from the acceleration measurements (para. [0030], “IVGD with an internal processor and a sensor to determine the location of the IVGD …”, para. [0042], “processor to determine the location … IVGD will output an acceleration from the internal sensor dominantly in the Z axis …”, para. [0050-0053], “processor software continues to monitor the inertial sensor outputs … inertial sensor provides X, Y and Z outputs … dominant sequential Z acceleration …” - the peak value being related to the dominant Z acceleration); and
identifying the location of the ingestible device in the gastrointestinal tract as small intestine in response to the peak value of acceleration measurements exceeding a threshold (para. [0050-0053], “dominant sequential Z acceleration, which continues for at least a predetermined time … indicates that the IVGD has left the stomach and is now in the small intestines …” - the threshold being the indication of a dominant Z acceleration); and
identifying the location of the ingestible device in the gastrointestinal tract as large intestine in response to the peak value of acceleration measurements being less than a second threshold (para. [0032], “located in the … large intestine, i.e., will not be confined to single axis motion …”, para. [0050-0053], “IVGD transitions from the small intestine to the large intestine, a 3 axis movement begins, i.e. the inertial sensor outputs do not continue to indicate dominant signal axis movement … Once the IVGD has reached the large intestine, the outputs of the inertial sensor will be randomly of X, Y, and Z, which is an indication that the IVGD is in the large intestine … ” - “a second threshold” is being interpreted as being an amplitude threshold of the acceleration different from “a predefined threshold” recited in claim 6. The IVGD is identified as being located within the large intestine when the outputs are randomly of X, Y, and Z. That is, the Z axis acceleration is no longer dominant, or the Z axis is below a second threshold because the X, Y, and Z are now random due to not being confined).
However, Yehuda does not explicitly disclose the thresholds are a predefined threshold and a second predefined threshold.
Chang teaches an analogous system and method of monitoring and tracking movement through the use of an accelerometer (Abstract, para. [0003], para. [0030], para. [0037]). Chang teaches measuring an acceleration, computing a peak value of acceleration over a period of time, and identifying a result by comparing the peak value of acceleration to a predefined threshold (para. [0085], “detect extrema of various different time-domain features and then analyzes the sequence of x, y, and z extrema and their properties (e.g., acceleration amplitude) with heurist rules to look for state transitions … match a pattern associated with a known transition …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Yehuda to explicitly compare the peak value of acceleration to predefined thresholds to determine the location, as taught by Chang. This is because Chang teaches comparing to pre-defined thresholds through rule-based monitoring is a known method of analyzing accelerometer data to determine specific movements (para. [0038], para. [0146]).
However, modified Yehuda does not explicitly disclose wirelessly communicating acceleration measurements from the ingestible device to another device outside of the gastrointestinal tract; and the processor is located within the another device.
Jones teaches a method of using an analogous ingestible device and determining the location of the ingestible device within a GI tract (Abstract, para. [0004]). Jones further teaches wirelessly communicating acceleration measurements from the ingestible device to another device outside of the gastrointestinal tract; and the processor is located within the another device (Fig. 16, para. [0007], para. [0185-0186], para. [0188]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by modified Yehuda to additionally wirelessly communicate acceleration measurements from the ingestible device to another device outside of the gastrointestinal tract; and have the processor located within the another device as taught by Jones. This is because Jones teaches transmitting data from the device to an external processor allows for the external processor to perform the analytics data, which one of ordinary skill in the art would recognize allows the device to preserve the battery life by offloading computation (para. [0188]).
Response to Arguments
Applicant’s arguments, see pages 7-8 of Remarks, filed 12/16/2025, with respect to the rejection(s) of claim(s) 1-7 and 15-16 under 35 USC 102 have been fully considered and are persuasive. Applicants have amended the claims to recite “a predefined threshold”. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Chang et al. (US 20130015976 A1).
Additionally, Applicant’s arguments, see page 8 of Remarks, filed 12/16/2025, regarding Yehuda not teaching “determining a peak value of acceleration” is not considered persuasive.
The claims currently do not limit what “a peak value of acceleration is”. As reiterated above, Yehuda teaches determining a peak, or dominant, acceleration in a specific axis.
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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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791