DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Claims 1, 2, 4-14, 16, and 17 are currently pending. Claims 1-14 have been amended. Claims 3 and 15 have been cancelled. Claims 16 and 17 have been added
Claim Objections
Claim 10 is objected to because of the following informalities:
In claim 10, “the stomach, the small intestine and the large intestine” should read “a stomach, a small intestine and a large intestine.”
Appropriate correction is required.
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 1, 2, 4-14, 16, and 17 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.
In Claims 1, 4, 6, 8, 9, 11, and 13 the claim limitation “one of the two or more sensors” renders the claim indefinite because the limitation is unclear. It is unclear because Claim 1 refers the pH sensor as the “one of the two or more sensors.” How is the “one of the two or more sensors” from claim 1 different from the ones in claims 4, 6, 8, 9, 11, and 13. For purposes of examination, the examiner recommends the applicant to amend the claim to separate “one of the two or more sensors” from another one of the two or more sensors. Due to the rejection of the independent claim, the dependent claims are also rejected because they are failing to cure the deficiencies as stated in the independent claim.
In Claims 5, 7, and 9 the claim limitation “correlating the degree of elevation...to a presence or an absence of H. pylori/ulcers/inflammation” renders the claim indefinite because the limitation is unclear. It is unclear how the degree of elevation is correlated to either a presence or absence of H. pylori/ulcers/inflammation. For example, is the degree of elevation a numerical value or a threshold that is correlated to either the presence or absence of H. pylori/ulcers/inflammation. For purposes of examination, the claim limitation is interpreted as a numerical value.
In Claim 11, the claim limitation “one of the two or more sensors of the smart pill comprises the ammonium sensor” renders the claim indefinite because the limitation is unclear. It is unclear because Claim 8 states that the one of the two or more sensors is either an ammonium sensor or nitric oxide sensor and Claim 9 states that the one of the two or more sensors is a nitric oxide. Now, Claim 11 is stating the one of the two or more sensors is an ammonium sensor. From claim 1, one of the sensors is a pH sensor, then Claim 9 states the second sensor is a nitric oxide sensor. Is the ammonium sensor from Claim 11 the third sensor? For purposes of examination purposes, the examiner recommends the applicant to clarify which two sensors are being claimed.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.
Claims 1, 2, 4-14, and 16-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Each of Claims 1, 2, 4-14, and 16-17 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1, 2, 4-14, and 16-17 recites at least one step or instruction for determining the presence of Helicobacter pylori infection within the subject’s digestive system, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. Accordingly, each of Claims 1, 2, 4-14, and 16-17 recites an abstract idea.
Specifically, claims 1 and 13 recite the following abstract ideas, as evidenced by the claim language: “orally administrating a smart pill to the subject; measuring a concentration of two or more of the analytes using the two or more sensors.” The measuring step describes a concept performed in the human mind or by use of pen and paper (including an observation, evaluation, judgement, opinion), and the orally administrating step describes a concept of organizing human activity. Thus, this claim is drawn to a Mental Process, which is an Abstract Idea.
Step 2A, Prong 2
Regarding Claims 1 and 13 (and their respective dependent claims) meets Step 2A, Prong 2 because the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. For example, Claims 1 and 13 recites the transmitting step where “transmitting, using the communication interface, the measured concentrations of the two or more analytes from the two or more sensors to a base device located outside of a body of the subject,” which is merely adding extra-solution activity to the judicial exception (MPEP 2106.05(g). The transmitting step does not provide an improvement to the following: function of a particular machine, manufacture or other technology; treatment or prophylaxis for a disease or medical condition; or transforming or reducing of a particular article to a different state or thing (MPEP 2106.04(d)).
Step 2B
Lastly, the claims as a whole are analyzed to determine whether any elements, or in combination, to ensure that they amount to significantly more than the judicial exception itself. However, these claims do not appear to recite additional elements that amount to significantly more than the judicial exception.
Regarding Claims 1 and 13 (and their respective dependent claims), it recites additional elements, more specifically smart pill, two or more sensors, a reference electrode, pH sensor, ammonium sensor, and nitric oxide sensor; [examiner’s note, the two or more sensors are the reference electrode, pH sensor, ammonium sensor, and nitric oxide sensor], are not significantly more because US Reference 20050179805 A1 provides evidence within Paragraph 0003 that smart pill and image sensors are well-known, routine, and conventional [Examiner’s note, conventional CMOS image sensors can measure pH, ammonium, and nitric oxide].
Though the CMOS image sensor from US Reference 20050179805 A1 can measure pH, ammonium, and nitric oxide, it is silent in teaching individual sensors to measure each of those analytes. US Reference 20160045656 A1 provides evidence within Paragraph 0104 that ammonium sensors are well-known, routine, and conventional. US Reference 4790925 A provides evidence within Column 1 lines 10-16 that nitric oxide sensors are well-known, routine, and conventional. And US Reference 4824561 A provides evidence within Column 3 lines 35-37 that nitric oxide sensors are well-known, routine, and conventional.
The above-identified additional elements, more specifically the power source, a communication interface, electronic circuits, base device, processing device, and cloud, are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
The dependent claims also fail to add something more to the abstract independent claims. Claims 7 and 8 merely recite what the metric is, which does not add anything significantly more. Claim 9 recites a mathematical step that adds to the Abstract Idea. Claim 10 recites a step of pre-solutional activity of data gathering. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Therefore, none of the Claims 1, 2, 4-14, and 16-17 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1, 2, 4-14, and 16-17 are not patent eligible and rejected under 35 U.S.C. 101.
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.
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.
Claims 1, 2, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Palti et al. (US 20060052667 A1) in view of Altschul et al. (US 20150343144 A1), Jones et al. (US 20200262908 A1), Rabinovitz et al. (US 20140316222 A1), and Gerlinger et al. (US 20200200654 A1).
Regarding Claim 1, Palti discloses a method for measuring concentrations of analytes in a gastrointestinal tract of a subject (Paragraph 0007; [Examiner’s note, ammonia or bicarbonate are analytes that are measured in the subject’s GI tract]), the method comprising:
orally a-dministering (S1) a smart pill (in vivo device – element 10) to the subject (Paragraph 0036), the smart pill comprising a sensor (image sensor – element 24), a power source (power source- element 25), a communication interface (receiving unit – element 1000), and electronic circuits (Paragraphs 0016), a sensor being able to measure a concentration of an analyte (image sensor – element 24; Paragraph 0016; [Examiner’s note the image sensor detects the color change from the pH-sensitive color-changing material, element 101, to determine the environmental pH changes.]), wherein the sensor is a pH sensor for measuring a hydrogen ion concentration (image sensor – element 24; Paragraph 0019, Chamber 102 may be illuminated by illumination unit 23 such that optical changes, typically as a result of pH or changes in the pH, which may occur in the sample contained in the chamber 102, may be detected by image sensor 24),
transmitting, using the communication interface (transmitter – element 26; Paragraph 0016), the measured concentrations of the sensor to a base device (receiving unit – element 1000) located outside of a body of the subject (Paragraphs 0022-0024), wherein the sensor of the smart pill comprise a non-degradable permeable polymeric membrane, said membrane being selective or sensitive to one of said two or more analytes enabling continuous (Paragraph 0019) and/or repeated measurements using said sensor [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.].
Palti teaches of a sensor that measures a concentration of an analyte, but is silent in teaching the sensor is a two or more sensors being able to measure a concentration of an analyte in the gastrointestinal tract of the subject, wherein the two or more sensors measure different analytes; the measured concentrations of the two or more analytes from the two or more sensors.
Altschul teaches two or more sensors being able to measure a concentration of an analyte (Altschul | sensors – element 22; Paragraph 0088) in the gastrointestinal tract of the subject (Altschul | Paragraph 0158), wherein the two or more sensors measure different analytes (Altschul | sensors – element 22; Paragraph 0140); the measured concentrations of the two or more analytes from the two or more sensors (Altschul | sensors – element 22; Paragraph 0140). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti to incorporate the teachings of two or more sensors measuring two or more analytes within the subject’s digestive tract from Altschul because the plurality of sensors, within the smart pill, allows for the pill to detect for the presence of drug overdose or abuse by measuring for analyte changes within the user’s digestive tract. (Altschul | Paragraphs 0021-0023).
Palti teaches of a pH sensor and the concentration of hydrogen ions measured determines the pH concentration. However, Palti in view of Altschul is silent in teaching the measuring hydrogen ion concentration correlates to the location the smart pill has traveled within the gastrointestinal tract. Jones teaches the pH sensor is able to locate the smart pill in the gastrointestinal tract by correlating the measured hydrogen ion concentrations to a location in the gastrointestinal tract (Jones | Paragraph 0365). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul to incorporate the teachings of a locating the smart pill in the gastrointestinal tract based on the measured hydrogen ion concentrations from Jones because by tracking the sensor data confirms the smart pill has reached its intended destination within the GI track (Jones | Paragraph 0005).
Palti in view of Altschul and Jones is silent in teaching a smart pill with reference electrode. Rabinovitz teaches a smart pill (Rabinovitz | device – element 10) with a reference electrode (Rabinovitz | reference electrode – element 12; Paragraph 0031). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul and Jones to incorporate the teachings of a reference electrode from Rabinovitz because the reference electrode provides a stable, constant, and non-fluctuating potential against which the potential of the working electrode can be accurately measured. This stable reference potential is critical for obtaining reliable and precise data in the highly dynamic and complex environment of the GI tract. Additionally, the reference electrode provides information to the physician whether H. pylori is present within the patient (Rabinovitz | Paragraph 0043).
Regarding Claim 2, Palti in view of Altschul, Jones, and Rabinovitz teaches the method according to claim 1. Palti teaches transmitting the measured concentrations of the analytes from the base device (Palti | in vivo device – element 10) to a processing device (Palti | processing unit - element 1006; Paragraphs 0022-0024) or a cloud [Examiner’s note, the claim comprises multiple limitations; however, only one of the two alternatives needs to be supported by the prior art.].
Palti teaches the measured concentration of the analytes but is silent in teaching the analyte concentration is two or more analytes by the two or more sensors. Altschul teaches two or more analytes by the two or more sensors (Altschul | sensors – element 22; Paragraph 0088). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti to incorporate the teachings of two or more sensors measuring two or more analytes within the subject’s digestive tract from Altschul because the plurality of sensors, within the smart pill, allows for the pill to detect for the presence of drug overdose or abuse by measuring for analyte changes within the user’s digestive tract. (Altschul | Paragraphs 0021-0023).
Palti in view of Altschul, and Rabinovitz are silent in teaching assessing a gut health of the subject based on the measured analyte concentrations; and assessing, the gut health of the subject based on the measured concentrations of the analytes using the processing device or the cloud. Jones teaches assessing a gut health of the subject based on the measured analyte concentrations (Jones | Paragraph | Paragraph 0490); and assessing, the gut health of the subject based on the measured concentrations of analytes of the sensors using the processing device (Jones | Paragraph | Paragraph 0490, The one or more sensors can include a chemical sensor, an electrical sensor, an optical sensor, an electromagnetic sensor, a light sensor, and/or a radiofrequency sensor) or cloud [Examiner’s note, the claim comprises multiple limitations; however, only one of the two alternatives needs to be supported by the prior art.]. One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul, and Rabinovitz to incorporate the teachings of assessing the subject’s gut health from Jones because the processed data provides insight on diagnosing a patient with a particular GI disease or disorder, monitor the disease or disorder, and providing the necessary treatments for this disease or disorder by the subject’s physician (Jones | Paragraphs 0013, 0114, 0555).
Regarding Claim 12, Palti in view of Altschul, Jones, and Rabinovitz teaches the method according to claim 1. Palti in view of Jones are silent teaching two or more sensors. Altschul teaches two or more sensors (Altschul | sensors – element 22; Paragraph 0088). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Jones, and Gerlinger to incorporate the teachings of two or more sensors measuring two or more analytes within the subject’s digestive tract from Altschul because the plurality of sensors, within the smart pill, allows for the pill to detect for the presence of drug overdose or abuse by measuring for analyte changes within the user’s digestive tract. (Altschul | Paragraphs 0021-0023).
Palti in view of Altschul, and Jones in calibrating the sensors of the smart pill before oral administration of the smart pill to the subject. Rabinovitz teaches calibrating (SO) the sensors before oral administration to the subject (Rabinovitz | Paragraph 0862). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul, and Jones to incorporate the teachings of calibrating the sensors in the ingestible device from Rabinovitz because sensors degrade and lose accuracy over time due to wear, environmental stress, or drift. The calibration process corrects this by comparing a sensor's readings to a known, traceable reference standard and adjusting the sensor to align with that standard. Once the sensors are calibrated, the ingestible device can collect reliable and accurate data (Rabinovitz | Paragraph 0862).
Regarding Claim 13, Palti discloses a smart pill (in vivo device – element 10), configured to operate inside a gastrointestinal tract of a subject and being capable of measuring analyte concentrations therein (Figure 1A, 3; Paragraphs 0007, 0014), the smart pill comprising: a power source (power source- element 25), a sensor comprising a non-degradable permeable polymeric membrane, said membrane being selective or sensitive to an analyte enabling continuous (Paragraph 0019) and/or repeated measurements using said sensor [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.]; a communication interface (transmitter – element 26; Paragraph 0016) comprising a transceiver for enabling wireless communication between the smart pill and a base device and being configured to transmit and receive data between the sensors and the base device (receiving unit – element 1000) (Paragraphs 0022-0024).
Palti teaches of the sensor that measures the analyte concentration but is silent in teaching the sensor is two or more sensors and the analyte concentration is two or more analyte concentrations; and two or more sensors, each being configured to measure a concentration of one of the two or more different analytes inside the gastrointestinal tract of the subject.
Altschul teaches two or more sensors that measures two or more analyte concentrations (Altschul | sensors – element 22; Paragraph 0088, 0140); and two or more sensors (Altschul | sensors – element 22; Paragraph 0088, 0140), each being configured to measure a concentration of one of the two or more different analytes inside the gastrointestinal tract of the subject (Altschul | Paragraph 0158). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti to incorporate the teachings of two or more sensors measuring two or more analytes within the subject’s digestive tract from Altschul because the plurality of sensors, within the smart pill, allows for the pill to detect for the presence of drug overdose or abuse by measuring for analyte changes within the user’s digestive tract. (Altschul | Paragraphs 0021-0023).
Palti in view of Altschul is silent in teaching electronic circuits for enabling a connection between the sensors, the electrode, and the communication interface, and being configured to convey data from the two or more sensors to the communication interface. Jones teaches electronic circuits (Jones | printed circuit board – element 120) for enabling a connection between the sensors, the electrode, and the communication interface, and being configured to convey data from the two or more sensors to the communication interface (Jones | Paragraph 0358). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti to incorporate the teachings of a smart pill containing multiple sensors which measures different analytes and locating the smart pill in the gastrointestinal tract based on the measured hydrogen ion concentrations from Jones because tracking the sensor data, which confirms the smart pill has reached its intended destination within the GI track, ensures the drug is released exactly where it is needed. This prevents the drug from being diluted or compromised by the harsh digestive environment, guaranteeing a higher dose arrives at the target site and improving the overall treatment (Jones | Paragraph 0005).
Palti in view of Altschul and Jones is silent in teaching is silent in teaching the electrode is a reference electrode within the smart pill. Rabinovitz teaches a smart pill (Rabinovitz | device – element 10) with a reference electrode (Rabinovitz | reference electrode – element 12; Paragraph 0031). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul and Jones to incorporate the teachings of a reference electrode from Rabinovitz because the reference electrode provides a stable, constant, and non-fluctuating potential against which the potential of the working electrode can be accurately measured. This stable reference potential is critical for obtaining reliable and precise data in the highly dynamic and complex environment of the GI tract. Additionally, the reference electrode provides information to the physician whether H. pylori is present within the patient (Rabinovitz | Paragraph 0043).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Palti in view of Altschul, Jones, Rabinovitz, Gerlinger et al. (US 20200200654 A1), and Hubbard et al. (US 20040077965 A1).
Regarding Claim 4, Palti in view of Altschul, Jones, and Rabinovitz teaches the method according to claim 2. Palti teaches wherein the subject is suspected to be suffering from a Helicobacter pylori infection (Palti | Paragraph 0014, 0027), the smart pill (Palti | in vivo device – element 10) is orally administering a predetermined amount of urea to the subject (Palti | Paragraph 0014, 0027).
Palti teaches of a sensor within a smart pill but is silent in teaching the sensor is two or more sensors that measures a concentration of two or more analytes; wherein the measuring a concentration of the two or more analytes and the transmitting the measured concentrations of the two or more analytes from the two or more sensors. Altschul teaches two or more sensors that measures a concentration of two or more analyte concentrations (Altschul | sensors – element 22; Paragraph 0088, 0140); wherein the measuring a concentration of the two or more analytes and the transmitting (Altschul | transponder – element 26C) the measured concentrations of the two or more analytes from the two or more sensors (Altschul | Paragraphs 0088, 0140, 0157). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti to incorporate the teachings of two or more sensors measuring two or more analytes within the subject’s digestive tract from Altschul because the plurality of sensors, within the smart pill, allows for the pill to detect for the presence of drug overdose or abuse by measuring for analyte changes within the user’s digestive tract. (Altschul | Paragraphs 0021-0023).
Palti teaches of a pH sensor and the concentration of hydrogen ions measured determines the pH concentration. However, Palti in view of Altschul is silent in teaching the measuring hydrogen ion concentration correlates to the location the smart pill has traveled within the stomach. Jones teaches continuously measuring, using the pH sensor, the hydrogen ion concentration to determine a location of the smart pill in the gastrointestinal tract (Jones | Paragraph 0380, 0553, 0578, 0582-0583; [Examiner’s note, the environmental sensor measures the pH differences along the GI track to determine the pill’s location. Paragraphs 0583 goes into more depth about specific pH changes along the GI track.]); determining, based on the measured hydrogen ion concentration, that the smart pill has reached a stomach of the subject (Jones | Paragraph 0365). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul to incorporate the teachings of utilizing a pH sensor to determine the location of the smart pill and determine when it has reached the patient’s stomach from Jones because the smart pill equipped with a pH sensor enables physicians to gather accurate data once it reaches the patient's stomach. Without this sensor, the collected data would be inconclusive, as the pill's location in the GI tract could not be reliably confirmed. Once the pill is positioned in the stomach, the processed data offers critical insights, assisting physicians in diagnosing specific gastrointestinal diseases or disorders, monitoring their progression, and tailoring necessary treatments (Jones | Paragraphs 0013, 0114, 0555).
Palti in view of Altschul and Jones is silent in teaching continuously measuring, using the ammonium sensor, the ammonium ion concentration after administration of the predetermined amount of urea; and continuously transmitting, using the communication interface, the measured concentrations of the two or more analytes from the two sensors to the base device. Rabinovitz teaches continuously measuring, the ammonium ion concentration after administration of the predetermined amount of urea (Rabinovitz | Paragraph 0036); and continuously transmitting, using the communication interface (Rabinovitz | display unit – element 18), the measured concentrations of the two or more analytes from the two sensors to the base device (Rabinovitz | Paragraph 0037). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul and Jones to incorporate the teachings of measuring the ammonium ion concentrations to detect for the presence of H. pylori from Rabinovitz. The H. pylori bacteria produces the enzyme urease, which breaks down urea into ammonia. The ammonium sensor then measures the resulting ammonia ion concentration. Detecting ammonia in the patient's stomach after administering urea is a key indicator for physicians that an H. pylori infection is present (Rabinovitz | Paragraph 0036, Once the coated layer is compromised, current may pass between working electrode 13 and reference electrode 12 (i.e., there is an increase in current), and measurements of such increase in current may indicate presence of ammonia, thus indicate presence of H. pylori).
Palti in view of Altschul, Jones, and Rabinovitz does not explicitly teach the ammonium sensor that measures ammonium. Gerlinger teaches the ammonium sensor (Gerlinger | probe – element 101) that measures ammonium within the GI tract (Gerlinger | Paragraph 0073; [Examiner’s note, the membrane is selective to measuring ammonium once the pill is ingested by the patient.]). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensors within the smart pill of Palti in view of Altschul, Jones, and Rabinovitz to incorporate the teachings of an ion-selective electrode from Gerlinger because the ion-selective electrode allows for measuring specific analytes within an unknown environment. For example, the ion-selective electrode from Gerlinger teaches measuring ammonium within a liquid sample of an unknown composition (Gerlinger | Paragraph 0073).
Lastly, Palti in view of Altschul, Jones, and Rabinovitz, and Gerlinger is silent in teaching measuring, using the ammonium sensor, a baseline ammonium ion concentration. Hubbard teaches measuring, using the ammonium sensor, a baseline ammonium ion concentration (Hubbard | Paragraph 0040-0041). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul, Jones, Rabinovitz, and Gerlinger to incorporate the teachings of an ammonium sensor from Hubbard because the ammonium sensor is used as a key indicator for the presence of H. pylori. The baseline provides the physician information regarding the current environment of the patient’s stomach before the administration of urea. The before and after ammonia concentration differences will allow the physician to determine whether the patient has the H. pylori bacteria (Hubbard | Paragraph 0035).
Regarding Claim 5, Palti in view of Altschul, Jones, Rabinovitz, Gerlinger, and Hubbard teaches the method according to claim 4. Palti in view of Jones, Rabinovitz, and Gerlinger are silent in teaching the sensor is two or more sensors that measure a concentration of two or more analytes; wherein the measuring a concentration of the two or more analytes and the transmitting the measured concentrations of the two or more analytes from the two or more sensors. Altschul teaches two or more sensors that measures a concentration of two or more analyte concentrations (Altschul | sensors – element 22; Paragraph 0088, 0140); wherein the measuring a concentration of the two or more analytes and the transmitting (Altschul | transponder – element 26C) the measured concentrations of the two or more analytes from the two or more sensors (Altschul | Paragraphs 0088, 0140, 0157). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Jones, Rabinovitz, and Gerlinger to incorporate the teachings of two or more sensors measuring two or more analytes within the subject’s digestive tract from Altschul because the plurality of sensors, within the smart pill, allows for the pill to detect for the presence of drug overdose or abuse by measuring for analyte changes within the user’s digestive tract. (Altschul | Paragraphs 0021-0023).
Palti in view of Altschul, Jones, Rabinovitz, and Gerlinger are silent in teaching wherein assessing the gut health of the subject based on the measured analyte concentrations: determining a degree of elevation of the ammonium ion concentration in the gastrointestinal tract by subtracting the baseline ammonium ion concentration from the measured ammonium ion concentration after administration of the predetermined amount of urea; correlating the degree of elevation of ammonium ion concentration to a presence or an absence of Helicobacter pylori activity in the stomach of the subject; and assessing the gut health of the subject based on the presence or absence of Helicobacter pylori activity, wherein a significant degree of elevation of the ammonium ion concentration in the gastrointestinal tract is correlated with the presence of Helicobacter pylori activity and wherein a non-significant degree of elevation of the ammonium ion concentration in the gastrointestinal tract or lack of elevation of the ammonium ion concentration in the gastrointestinal tract is correlated with the absence of Helicobacter pylori activity.
Hubbard teaches wherein assessing the gut health of the subject based on the measured analyte concentrations: determining a degree of elevation of the ammonium ion concentration in the gastrointestinal tract by subtracting the baseline ammonium ion concentration from the measured ammonium ion concentration after administration of the predetermined amount of urea (Hubbard | Table 2; Figure 4; Paragraphs 0073-0076); correlating the degree of elevation of ammonium ion concentration to a presence or an absence of Helicobacter pylori activity in the stomach of the subject (Hubbard | Table 2; Paragraph 0076; [Examiner’s note, on Table 2 under the column labeled “% change: urea vs baseline,” highlights the key difference where the patient has the presence or absence of H. pylori. Where patients who have H. pylori have greater than 100% change when comparing urea and the baseline, while as patients who don’t have H. pylori have less than 100% change when comparing urea and the baseline.]); and assessing the gut health of the subject based on the presence or absence of Helicobacter pylori activity, wherein a significant degree of elevation of the ammonium ion concentration in the gastrointestinal tract is correlated with the presence of Helicobacter pylori activity and wherein a non-significant degree of elevation of the ammonium ion concentration in the gastrointestinal tract or lack of elevation of the ammonium ion concentration in the gastrointestinal tract is correlated with the absence of Helicobacter pylori activity (Hubbard | Table 2; Paragraph 0076; [Examiner’s note, on Table 2 under the column labeled “% change: urea vs baseline,” highlights the key difference where the patient has the presence or absence of H. pylori. Where patients who have H. pylori have greater than 100% change when comparing urea and the baseline, while as patients who don’t have H. pylori have less than 100% change when comparing urea and the baseline.]).
One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul, Jones, Rabinovitz, and Gerlinger to incorporate the teachings of an ammonium sensor from Hubbard because the ammonium sensor is used as a key indicator for the presence of H. pylori. The baseline provides the physician information regarding the current environment of the patient’s stomach before the administration of urea. The before and after ammonia concentration differences will allow the physician to determine whether the patient has the H. pylori bacteria (Hubbard | Paragraph 0035).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Palti in view of Altschul, Jones, Rabinovitz, Gerlinger et al. (US 20200200654 A1), Hubbard et al. (US 20040077965 A1), and Gobert et al. (“Helicobacter pylori arginase inhibits nitric oxide production by eukaryotic cells: A strategy for bacterial survival,” 2001, reference U on PTO-892; [Examiner’s note, NPL cited in PTO-892 filed in 10/17/25]).
Regarding Claim 6, Palti in view of Altschul, Jones, and Rabinovitz teaches the method according to claim 2. Palti teaches wherein the subject is suspected to be suffering from a Helicobacter pylori infection (Palti | Paragraph 0014, 0027) and the sensor (Palti | image sensor – element 24) within the smart pill (Palti | in vivo device – element 10); orally administering a predetermined amount of urea to the subject (Palti | Paragraph 0014, 0027).
Palti teaches of a sensor but is silent in teaching that the sensor is the three sensors which measures the three analyte concentrations. Altschul teaches the measured concentrations of each of the three analytes from the three sensors (Altschul | sensors – element 22; Paragraph 0088). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti to incorporate the teachings of two or more sensors measuring two or more analytes within the subject’s digestive tract from Altschul because the plurality of sensors, within the smart pill, allows for the pill to detect for the presence of drug overdose or abuse by measuring for analyte changes within the user’s digestive tract. (Altschul | Paragraphs 0021-0023).
Palti teaches of a pH sensor and the concentration of hydrogen ions measured determines the pH concentration. However, Palti in view of Altschul is silent in teaching the measuring hydrogen ion concentration correlates to the location the smart pill has traveled within the gastrointestinal tract. Jones teaches continuously measuring, using the pH sensor, the hydrogen ion concentration to determine the location of the smart pill in the gastrointestinal tract (Jones | Paragraph 0380, 0553, 0578, 0582-0583; [Examiner’s note, the environmental sensor measures the pH differences along the GI track to determine the pill’s location. Paragraphs 0583 goes into more depth about specific pH changes along the GI track.]); determining, based on the measured hydrogen ion concentration, that the smart pill has reached a stomach of the subject (Jones | Paragraph 0365). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul to incorporate the teachings of utilizing a pH sensor to determine the location of the smart pill and determine when it has reached the patient’s stomach from Jones because the smart pill equipped with a pH sensor enables physicians to gather accurate data once it reaches the patient's stomach. Without this sensor, the collected data would be inconclusive, as the pill's location in the GI tract could not be reliably confirmed. Once the pill is positioned in the stomach, the processed data offers critical insights, assisting physicians in diagnosing specific gastrointestinal diseases or disorders, monitoring their progression, and tailoring necessary treatments (Jones | Paragraphs 0013, 0114, 0555).
Palti in view of Altschul and Jones is silent in teaching continuously measuring, the ammonium ion concentration after administration of the predetermined amount of urea; and continuously transmitting, using the communication interface, the measured concentrations of each of the analytes from the sensors to the base device. Rabinovitz teaches continuously measuring, the ammonium ion concentration after administration of the predetermined amount of urea (Rabinovitz | Paragraph 0036); and continuously transmitting, using the communication interface (Rabinovitz | display unit – element 18), the measured concentrations of each of the analytes from the sensors to the base device (Rabinovitz | Paragraph 0037). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul and Jones to incorporate the teachings of measuring the ammonium ion concentrations to detect for the presence of H. pylori from Rabinovitz. The H. pylori bacteria produces the enzyme urease, which breaks down urea into ammonia. The ammonium sensor then measures the resulting ammonia ion concentration. Detecting ammonia in the patient's stomach after administering urea is a key indicator for physicians that an H. pylori infection is present (Rabinovitz | Paragraph 0036, Once the coated layer is compromised, current may pass between working electrode 13 and reference electrode 12 (i.e., there is an increase in current), and measurements of such increase in current may indicate presence of ammonia, thus indicate presence of H. pylori).
Palti in view of Altschul, Jones, and Rabinovitz, more specifically Altschul, teaches two or more sensors. Palti in view of Altschul and Jones is silent in explicitly teaching the ammonium sensor is one of the two or more sensors; an ammonium sensor for measuring ammonium ion concentrations. Gerlinger teaches the ammonium sensor is one of the two or more sensors (Gerlinger | probe – element 101; Paragraphs 0003, 0073-0074); the ammonium sensor is one of the two or more sensors; an ammonium sensor for measuring ammonium ion concentrations (Gerlinger | probe – element 101; Paragraphs 0003, 0073-0074). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensors within the smart pill of Palti in view of Altschul, Jones, and Rabinovitz to incorporate the teachings of an ion-selective electrode from Gerlinger because the ion-selective electrode allows for measuring specific analytes within an unknown environment. For example, the ion-selective electrode from Gerlinger teaches measuring ammonium within a liquid sample of an unknown composition (Gerlinger | Paragraph 0073).
Palti in view of Altschul, Jones, Rabinovitz, and Gerlinger is silent in teaching measuring, using the ammonium sensor, a baseline ammonium ion concentration. Hubbard teaches measuring, using the ammonium sensor, a baseline ammonium ion concentration (Hubbard | Paragraph 0040-0041). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul, Jones, Rabinovitz, and Gerlinger to incorporate the teachings of an ammonium sensor from Hubbard because the ammonium sensor is used as a key indicator for the presence of H. pylori. The baseline provides the physician information regarding the current environment of the patient’s stomach before the administration of urea. The before and after ammonia concentration differences will allow the physician to determine whether the patient has the H. pylori bacteria (Hubbard | Paragraph 0035).
Palti in view of Altschul, Jones, Rabinovitz, Gerlinger, and Hubbard, more specifically Altschul and Gerlinger, teaches one of the two or more sensors includes an ammonium sensor, but is silent in teaching one of the two or more sensors includes a nitric oxide sensor for measuring nitric oxide concentrations. Additionally, Palti in view of Altschul and Jones is silent in teaching continuously measuring, using the nitric oxide sensor, respectively, the nitric oxidea nitric oxide sensor for measuring nitric oxide concentrations as a concentration of one analyte (Gobert | Page 2, under section “Measurement of NO Concentration”); continuously measuring, using the nitric oxide sensor (Gobert | Page 2, under section “Measurement of NO Concentration”), respectively, nitric oxide concentrations after administration of urea (Gobert | Page 1 – Left Column First Paragraph, The substantially higher levels of NO generated by macrophages cocultured with rocF-deficient H. pylori resulted in efficient killing of the bacteria, whereas wild-type H. pylori exhibited no loss of survival under these conditions. Killing of the arginase-deficient H. pylori was NO-dependent, because peritoneal macrophages from iNOS/ mice failed to affect the survival of the rocF mutant. Thus, bacterial arginase allows H. pylori to evade the immune response by down-regulating eukaryotic NO production; [Examiner’s note, when urea is entered into the stomach, the urease in the H. pylori bacteria breaks down urea into ammonia. Nitric oxide’s (NO) role is to eliminate H. pylori. Thus if H. pylori is present within the stomach, there will be a smaller concentration of nitric oxide.]). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul, Jones, Rabinovitz, Gerlinger, and Hubbard to incorporate the teachings of measuring nitric oxide from Gobert because the concentration of nitric oxide can provide insight to a physician that there is presence of H. pylori, which may result in a domino effect of causing additional health issues (Gobert | Page 1 – Left Column Second Paragraph, H. pylori causes chronic gastritis, peptic ulcers, and gastric carcinoma and lymphoma, leading to its classification as a Class I carcinogen (2). Despite inciting substantial acute and chronic immune and inflammatory responses, H. pylori infection generally persists for the life of the host. Understanding how the bacterium evades the host response remains a critical issue in managing the public health burden of this infection.).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Palti in view of Altschul, Jones, Rabinovitz, Gerlinger, Hubbard, Gobert, and Sakaguchi et al. (“Increased Expression of Inducible Nitric Oxide Synthase And Peroxynitrite In Helicobacter Pylori Gastric Ulcer,” 1999, reference V on the PTO-892; [Examiner’s note, NPL cited in PTO-892 filed in 10/17/25]).
Regarding Claim 7, Palti in view of Altschul, Jones, Rabinovitz, Gerlinger, Hubbard, and Gobert teaches the method according to claim 6. As discussed in Claim 6, Palti is teaches of the sensor, but is silent in teaching the sensor is three sensors that measure three analyte concentrations. Altschul teaches the measured concentrations of each of the three analytes from the three sensors (Altschul | sensors – element 22; Paragraph 0088). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti to incorporate the teachings of two or more sensors measuring two or more analytes within the subject’s digestive tract from Altschul because the plurality of sensors, within the smart pill, allows for the pill to detect for the presence of drug overdose or abuse by measuring for analyte changes within the user’s digestive tract. (Altschul | Paragraphs 0021-0023).
Palti in view of Altschul, Jones, Rabinovitz, and Gerlinger are silent in teaching wherein assessing the gut health of the subject based on the measured analyte concentrations: determining a degree of elevation of the ammonium ion concentration in the gastrointestinal tract by subtracting the baseline ammonium ion concentration from the measured ammonium ion concentration after administration of the predetermined amount of urea and correlating the degree of elevation of the ammonium ion concentration to a presence or an absence of Helicobacter pylori activity in the stomach of the subject; assessing the gut health of the subject based on the presence or absence of Helicobacter pylori activity and ulcers and/or inflammation, wherein a significant degree of elevation of the ammonium ion concentration; are correlated with the presence of Helicobacter pylori activity; wherein the non-significant degree of elevation or no elevation of the ammonium ion concentration are correlated with an absence of Helicobacter pylori activity.
Hubbard teaches wherein assessing the gut health of the subject based on the measured analyte concentrations: determining a degree of elevation of the ammonium ion concentration in the gastrointestinal tract by subtracting the baseline ammonium ion concentration from the measured ammonium ion concentration after administration of the predetermined amount of urea (Hubbard | Table 2; Figure 4; Paragraphs 0073-0076); correlating the degree of elevation of the ammonium ion concentration to a presence or an absence of Helicobacter pylori activity in the stomach of the subject (Hubbard | Table 2; Paragraph 0076; [Examiner’s note, on Table 2 under the column labeled “% change: urea vs baseline,” highlights the key difference where the patient has the presence or absence of H. pylori. Where patients who have H. pylori have greater than 100% change when comparing urea and the baseline, while as patients who don’t have H. pylori have less than 100% change when comparing urea and the baseline.]); assessing the gut health of the subject based on the presence or absence of Helicobacter pylori activity and ulcers (Hubbard | Paragraph 0003) and/or inflammation [Examiner' s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.], wherein a significant degree of elevation of the ammonium ion concentration are correlated with the presence of Helicobacter pylori activity; and wherein the non-significant degree of elevation or no elevation of the ammonium ion concentration are correlated with an absence of Helicobacter pylori activity (Hubbard | Table 2; Paragraph 0076; [Examiner’s note, on Table 2 under the column labeled “% change: urea vs baseline,” highlights the key difference where the patient has the presence or absence of H. pylori. Where patients who have H. pylori have greater than 100% change when comparing urea and the baseline, while as patients who don’t have H. pylori have less than 100% change when comparing urea and the baseline.]). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul, Jones, Rabinovitz, and Gerlinger to incorporate the teachings of an ammonium sensor from Hubbard because the ammonium sensor is used as a key indicator for the presence of H. pylori. The baseline provides the physician information regarding the current environment of the patient’s stomach before the administration of urea. The before and after ammonia concentration differences will allow the physician to determine whether the patient has the H. pylori bacteria (Hubbard | Paragraph 0035).
Palti in view of Altschul, Jones, Rabinovitz, Gerlinger, and Hubbard are silent in teaching determining a degree of elevation of the nitric oxide concentration in the gastrointestinal tract by comparing the measured nitric oxide concentration to a predetermined threshold. Gobert teaches determining a degree of elevation of the nitric oxide concentration in the gastrointestinal tract by comparing the measured nitric oxide concentration to a predetermined threshold ((Gobert | Page 1; Figure 2 on Page 4; [Examiner’s note, The study compared wild-type H. pylori (WT) with a mutant strain (rocF::aphA3) that lacks the functional rocF gene. The experiment aimed to show that the WT strain, by possessing the rocF gene, is more resistant to the host's immune system. Figure 2 shows an increase in nitric oxide levels specifically when the rocF::aphA3 strain was present. This surge in nitric oxide, produced by the iNOS immune response, resulted in the elimination of the vulnerable rocF::aphA3 bacteria, demonstrating how the rocF gene provides a survival advantage for the wild-type strain.]). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul, Jones, Rabinovitz, Gerlinger, and Hubbard to incorporate the teachings of measuring nitric oxide from Gobert because the concentration of nitric oxide can provide insight to a physician that there is presence of H. pylori, which may result in a domino effect of causing additional health issues (Gobert | Page 1 – Left Column Second Paragraph, H. pylori causes chronic gastritis, peptic ulcers, and gastric carcinoma and lymphoma, leading to its classification as a Class I carcinogen (2). Despite inciting substantial acute and chronic immune and inflammatory responses, H. pylori infection generally persists for the life of the host. Understanding how the bacterium evades the host response remains a critical issue in managing the public health burden of this infection.).
Palti in view of Altschul, Jones, Rabinovitz, Gerlinger, Hubbard, and Gobert is silent in teaching correlating the degree of elevation of nitric oxide concentrations to the presence or absence of ulcers and/or inflammation; wherein a significant degree of elevation of ammonium ion concentrations and nitric oxide concentrations are correlated with the presence of Helicobacter pylori activity and ulcers and/or inflammation, wherein a significant degree of elevation of ammonium ion concentrations and a non-significant degree of elevation of nitric oxide concentrations are correlated with the presence of Helicobacter pylori activity but no ulcers and/or inflammation, wherein a non-significant degree of elevation or no elevation of ammonium ion concentrations and a significant degree of elevation of nitric oxide concentrations are correlated with the absence of Helicobacter pylori activity and the presence of ulcers and/or inflammation, and wherein a non-significant degree of elevation or no elevation of ammonium ion concentrations and a non-significant degree of elevation of nitric oxide concentrations are correlated with the absence of Helicobacter pylori activity and ulcers and/or inflammation.
Sakaguchi teaches correlating the degree of elevation of nitric oxide concentrations to the presence or absence of ulcers and/or inflammation (Sakaguchi | Page 6 – first Paragraph under Discussion); wherein a significant degree of elevation of ammonium ion concentrations [Examiner’s note, the art from Hubbard teaches when the H. pylori bacteria interacts with urea, the enzyme breaks it down to ammonia. Therefore, the presence of ammonia indicate the presence of H. pylori. The study from Sakaguchi teaches the nitric oxide concentrations are correlated with the presence of Helicobacter pylori activity and ulcers (Sakaguchi | Page 6 – first Paragraph under Discussion) and/or inflammation; wherein a significant degree of elevation of ammonium ion concentrations and a non-significant degree of elevation of nitric oxide concentrations are correlated with the presence of Helicobacter pylori activity [Examiner’s note, as discussed from Hubbard’s art, when the H. pylori bacteria interacts with urea, the enzyme breaks it down to ammonia. Therefore, the presence of ammonia indicate the presence of H. pylori] but no ulcers (Sakaguchi | Page 6 – first Paragraph under Discussion) and/or inflammation; wherein a non-significant degree of elevation or no elevation of ammonium ion concentrations and a significant degree of elevation of nitric oxide concentrations are correlated with the absence of Helicobacter pylori activity [Examiner’s note, as discussed from Hubbard’s art, when the H. pylori bacteria interacts with urea, the enzyme breaks it down to ammonia. Therefore, the presence of ammonia indicate the presence of H. pylori. However, once the patient takes urea and does not metabolize to ammonia, then the physician can determine there is no presence of H. pylori.] and the presence of ulcers (Sakaguchi | Page 6 – first Paragraph under Discussion) and/or inflammation, and wherein a non-significant degree of elevation or no elevation of ammonium ion concentrations and a non-significant degree of elevation of nitric oxide concentrations are correlated with the absence of Helicobacter pylori activity [Examiner’s note, as discussed from Hubbard’s art, when the H. pylori bacteria interacts with urea, the enzyme breaks it down to ammonia. Therefore, the presence of ammonia indicate the presence of H. pylori. However, once the patient takes urea and does not metabolize to ammonia, then the physician can determine there is no presence of H. pylori.] and ulcers and/or inflammation (Sakaguchi | Page 6 – first Paragraph under Discussion).
One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul, Jones, Rabinovitz, Gerlinger, Hubbard, and Gobert to incorporate the teachings of nitric oxide indicating the presence of ulcers from Sakaguchi because ulcer formations can occur whether H. pylori is present or not. The patient can develop gastric ulcers due to an increase in NO production. When a physician sees lab results that show the NO values being greater than the standard value, they will provide the necessary medications and treatment to reduce the ulcer from increasing (Sakaguchi | Page 6 – first Paragraph under Discussion).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Palti in view of Altschul, Jones, Rabinovitz, Gerlinger et al. (US 20200200654 A1), and Tsutsumi at al. (US 20020197342 A1).
Regarding Claim 8, Palti in view of Altschul, Jones, Rabinovitz, and Gerlinger teaches the method according to claim 2. Palti teaches the sensor (Palti | image sensor – element 24) within the smart pill (Palti | in vivo device – element 10); the smart pill travels through the gastrointestinal tract, wherein said measuring includes measuring in the stomach, measuring in the small intestine and measuring in the large intestine of the subject (Palti | Paragraph 0007).
Palti teaches of a sensor within a smart pill but is silent in teaching the sensor is two or more sensors that measures a concentration of two or more analytes; wherein the measuring a concentration of the two or more analytes and the transmitting the measured concentrations of the two or more analytes from the two or more sensors. Altschul teaches two or more sensors that measures a concentration of two or more analyte concentrations (Altschul | sensors – element 22; Paragraph 0088, 0140); wherein the measuring a concentration of the two or more analytes and the transmitting (Altschul | transponder – element 26C) the measured concentrations of the two or more analytes from the two or more sensors (Altschul | Paragraphs 0088, 0140, 0157). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti to incorporate the teachings of two or more sensors measuring two or more analytes within the subject’s digestive tract from Altschul because the plurality of sensors, within the smart pill, allows for the pill to detect for the presence of drug overdose or abuse by measuring for analyte changes within the user’s digestive tract. (Altschul | Paragraphs 0021-0023).
Palti teaches of a pH sensor and the concentration of hydrogen ions measured determines the pH concentration. However, Palti in view of Altschul is silent in teaching the measuring hydrogen ion concentration correlates to the location the smart pill has traveled within the gastrointestinal tract. Jones teaches continuously measuring, using the pH sensor, the hydrogen ion concentration to determine a location of the smart pill in the gastrointestinal tract (Jones | Paragraph 0380, 0553, 0578, 0582-0583; [Examiner’s note, the environmental sensor measures the pH differences along the GI track to determine the pill’s location. Paragraphs 0583 goes into more depth about specific pH changes along the GI track.]). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul to incorporate the teachings of utilizing a pH sensor to determine the location of the smart pill and determine when it has reached the patient’s stomach from Jones because the smart pill equipped with a pH sensor enables physicians to gather accurate data once it reaches the patient's stomach. Without this sensor, the collected data would be inconclusive, as the pill's location in the GI tract could not be reliably confirmed. Once the pill is positioned in the stomach, the processed data offers critical insights, assisting physicians in diagnosing specific gastrointestinal diseases or disorders, monitoring their progression, and tailoring necessary treatments (Jones | Paragraphs 0013, 0114, 0555).
Palti in view of Altschul and Jones is silent in teaching one of the two or more sensors of the smart pill comprises a nitric oxide sensor for measuring a nitric oxide concentration or one of the two or more sensors of the smart pill comprises a sensor for measuring an ammonium ion concentration as a concentration of one of the two or more analytes; continuously measuring, using the nitric oxide sensor or the sensor, the nitric oxide concentration or the ammonium ion concentration as the smart pill travels through the gastrointestinal tract; continuously transmitting, using the communication interface, the measured concentrations of the two analytes from the two sensors to the base device. Rabinovitz teaches one of the two or more sensors of the smart pill comprises a nitric oxide sensor for measuring a nitric oxide concentration [Examiner' s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.] or one of the two or more sensors of the smart pill comprises a sensor for measuring an ammonium ion concentration as a concentration of one of the two or more analytes (Rabinovitz | Paragraph 0036); continuously measuring, using the sensor, the ammonium ion concentration (Rabinovitz | Paragraph 0036); and continuously transmitting, using the communication interface (Rabinovitz | display unit – element 18), the measured concentrations of the two analytes from the two sensors to the base device (Rabinovitz | Paragraph 0037). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul and Jones to incorporate the teachings of measuring the ammonium ion concentrations to detect for the presence of H. pylori from Rabinovitz. The H. pylori bacteria produces the enzyme urease, which breaks down urea into ammonia. The ammonium sensor then measures the resulting ammonia ion concentration. Detecting ammonia in the patient's stomach after administering urea is a key indicator for physicians that an H. pylori infection is present (Rabinovitz | Paragraph 0036, Once the coated layer is compromised, current may pass between working electrode 13 and reference electrode 12 (i.e., there is an increase in current), and measurements of such increase in current may indicate presence of ammonia, thus indicate presence of H. pylori).
Palti in view of Altschul, Jones, and Rabinovitz, more specifically Altschul, teaches two or more sensors. Palti in view of Altschul and Jones is silent in explicitly teaching the ammonium sensor is one of the two or more sensors; an ammonium sensor for measuring ammonium ion concentrations. Gerlinger teaches the ammonium sensor is one of the two or more sensors (Gerlinger | probe – element 101; Paragraphs 0003, 0073-0074); the ammonium sensor is one of the two or more sensors; an ammonium sensor for measuring ammonium ion concentrations (Gerlinger | probe – element 101; Paragraphs 0003, 0073-0074). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensors within the smart pill of Palti in view of Altschul, Jones, and Rabinovitz to incorporate the teachings of an ion-selective electrode from Gerlinger because the ion-selective electrode allows for measuring specific analytes within an unknown environment. For example, the ion-selective electrode from Gerlinger teaches measuring ammonium within a liquid sample of an unknown composition (Gerlinger | Paragraph 0073).
Palti in view of Altschul, Jones, Rabinovitz, and Gerlinger is silent in teaching wherein the subject is suffering from, or is suspected to be suffering from, inflammatory bowel disease and/or suspected of presenting increased protein fermentation. Tsutsumi teaches the subject is suffering from, or is suspected to be suffering from, inflammatory bowel disease and/or suspected of presenting increased protein fermentation (Tsutsumi | Paragraph 0020; [Examiner’s note, the presence of increased protein fermentation is due to high concentrations of ammonium ions. Additionally, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.]). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul, Jones, Rabinovitz, and Gerlinger to incorporate the teachings of the linear relationship between protein fermentation and ammonium ion concentration from Tsutsumi because a detection of high amounts of ammonium ion concentrations within the patient can deteriorate their health and cause an illness (Tsutsumi | Paragraph 0020, it is known that increase of the blood ammonia concentration causes emesis, fever or pyrexia, and in serious cases, hepato celebral encephalopathy).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Palti in view of Altschul, Jones, Rabinovitz, Gerlinger, Tsutsumi, Gobert et al. (“Helicobacter pylori arginase inhibits nitric oxide production by eukaryotic cells: A strategy for bacterial survival,” 2001, reference U on PTO-892; [Examiner’s note, NPL cited in PTO-892 filed in 10/17/25]), and Sakaguchi et al. (“Increased Expression Of Inducible Nitric Oxide Synthase And Peroxynitrite In Helicobacter Pylori Gastric Ulcer,” 1999, reference V on the PTO-892; [Examiner’s note, NPL cited in PTO-892 filed in 10/17/25]).
Regarding Claim 9, Palti in view of Altschul, Jones, Rabinovitz, Gerlinger, and Tsutsumi teaches the method according to claim 8. Palti teaches the sensor (Palti | image sensor – element 24) within the smart pill (Palti | in vivo device – element 10).
Palti teaches of a sensor within a smart pill but is silent in teaching the sensor is two or more sensors that measures a concentration of two or more analytes. Altschul teaches two or more sensors that measures a concentration of two or more analyte concentrations (Altschul | sensors – element 22; Paragraph 0088, 0140). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti to incorporate the teachings of two or more sensors measuring two or more analytes within the subject’s digestive tract from Altschul because the plurality of sensors, within the smart pill, allows for the pill to detect for the presence of drug overdose or abuse by measuring for analyte changes within the user’s digestive tract. (Altschul | Paragraphs 0021-0023).
Altschul, Jones, Rabinovitz, Gerlinger, and Tsutsumi, more specifically Altschul, teaches one of the two or more sensors but is silent in teaching one of the two or more sensors includes a nitric oxide sensor for measuring nitric oxide concentrations. Additionally, they are silent in teaching wherein assessing the gut health of the subject based on the measured analyte concentrations; determining a degree of elevation of the nitric oxide concentration in the gastrointestinal tract by comparing the measured nitric oxidethe nitric oxide concentration. Gobert teaches nitric oxide sensor for measuring nitric oxide concentrations and wherein assessing the gut health of the subject based on the measured analyte concentrations (Gober | Page 2, under section “Measurement of NO Concentration”); determining a degree of elevation of the nitric oxide concentration in the gastrointestinal tract by comparing the measured nitric oxide concentration to a predetermined threshold (Gobert | Page 1; Figure 2 on Page 4; [Examiner’s note, The study compared wild-type H. pylori (WT) with a mutant strain (rocF::aphA3) that lacks the functional rocF gene. The experiment aimed to show that the WT strain, by possessing the rocF gene, is more resistant to the host's immune system. Figure 2 shows an increase in nitric oxide levels specifically when the rocF::aphA3 strain was present. This surge in nitric oxide, produced by the iNOS immune response, resulted in the elimination of the vulnerable rocF::aphA3 bacteria, demonstrating how the rocF gene provides a survival advantage for the wild-type strain.]); correlating the degree of elevation of the nitric oxide concentration to a presence or an absence of ulcers and/or inflammation, wherein the measured nitric oxide concentration being above or equal to the predetermined threshold is considered as a significant degree of elevation of the nitric oxide concentration (Gobert | Page 1; Figure 2 on Page 4; [Examiner’s note, figure 2 highlights the rocF::aphA3 strain contains nitric oxide being above the predetermined threshold which is the values of the WT strain.]). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Altschul, Jones, Rabinovitz, Gerlinger, and Tsutsumi to incorporate the teachings of measuring nitric oxide from Gobert because the concentration of nitric oxide can provide insight to a physician that there is presence of H. pylori, which may result in a domino effect of causing additional health issues (Gobert | Page 1 – Left Column Second Paragraph, H. pylori causes chronic gastritis, peptic ulcers, and gastric carcinoma and lymphoma, leading to its classification as a Class I carcinogen (2). Despite inciting substantial acute and chronic immune and inflammatory responses, H. pylori infection generally persists for the life of the host. Understanding how the bacterium evades the host response remains a critical issue in managing the public health burden of this infection.).
Altschul, Jones, Rabinovitz, Gerlinger, Tsutsumi, and Gobert are silent in teaching assessing the gut health of the subject based on the presence or absence of ulcers and/or inflammation, wherein the significant degree of elevation of the nitric oxide concentration is correlated with the presence of ulcers and/or inflammation, and wherein a non-significant degree of elevation of the nitric oxide concentration is correlated with the absence of ulcers and inflammation. Sakaguchi teaches assessing the gut health of the subject based on the presence or absence of ulcers (Sakaguchi | Page 6 – first Paragraph under Discussion) and/or inflammation [Examiner' s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.], wherein the significant degree of elevation of the nitric oxide concentration is correlated with the presence of ulcers (Sakaguchi | Page 6 – first Paragraph under Discussion) and/or inflammation [Examiner' s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.], and wherein a non-significant degree of elevation of the nitric oxide concentration is correlated with the absence of ulcers and inflammation (Sakaguchi | Page 6 – first Paragraph under Discussion). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Altschul, Jones, Rabinovitz, Gerlinger, Tsutsumi, and Gobert to incorporate the teachings of nitric oxide indicating the presence of ulcers from Sakaguchi because ulcer formations can occur whether H. pylori is present or not. The patient can develop gastric ulcers due to an increase in NO production. When a physician sees lab results that show the NO values being greater than the standard value, they will provide the necessary medications and treatment to reduce the ulcer from increasing (Sakaguchi | Page 6 – first Paragraph under Discussion).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Palti in view of Altschul, Jones, Rabinovitz, Gerlinger, Tsutsumi, Gobert, Sakaguchi, and Kimura et al. (“Increased nitric oxide production and inducible nitric oxide synthase activity in colonic mucosa of patients with active ulcerative colitis and Crohn's disease,” 1997, reference W on PTO-892; [Examiner’s note, NPL cited in PTO-892 filed in 10/17/25]).
Regarding Claim 10, Palti in view of Altschul, Jones, Rabinovitz, Gerlinger, Tsutsumi, Gobert, and Sakaguchi teaches the method according to claim 9. Palti in view of Altschul, Jones, Gerlinger, Tsutsumi, and Sakaguchi is silent in teaching tracking the data collection at different locations in the gastrointestinal tract of the subject, including the stomach, the small intestine and the large intestine. Rabinovitz teaches tracking the data collection at different locations in the gastrointestinal tract of the subject, including the stomach, the small intestine and the large intestine (Rabinovitz | ingestible device – element 100; Paragraph 0354). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul, Jones, Gerlinger, Tsutsumi, and Sakaguchi to incorporate the teachings of tracking the data collection at different locations in the gastrointestinal tract of the subject, including the stomach, the small intestine and the large intestine from Rabinovitz. Without tracking the location by the data then the data collection would be inconclusive, as the pill's location in the GI tract could not be reliably confirmed (Rabinovitz | Paragraph 0693).
Palti in view of Altschul, Jones, Rabinovitz, Gerlinger, Tsutsumi, and Sakaguchi are silent in teaching wherein the determining a degree of elevation of the nitric oxide concentration in the gastrointestinal tract. Gobert teaches wherein the determining a degree of elevation of the nitric oxide concentration in the gastrointestinal tract (Gobert | Page 5 – Left Column First Paragraph). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul, Jones, Rabinovitz, Gerlinger, Tsutsumi, and Sakaguchi to incorporate the teachings of measuring nitric oxide from Gobert because the concentration of nitric oxide can provide insight to a physician that there is presence of H. pylori, which may result in a domino effect of causing additional health issues (Gobert | Page 1 – Left Column Second Paragraph, H. pylori causes chronic gastritis, peptic ulcers, and gastric carcinoma and lymphoma, leading to its classification as a Class I carcinogen (2). Despite inciting substantial acute and chronic immune and inflammatory responses, H. pylori infection generally persists for the life of the host. Understanding how the bacterium evades the host response remains a critical issue in managing the public health burden of this infection.).
Palti in view of Altschul, Jones, Rabinovitz, Gerlinger, Tsutsumi, Gobert, and Sakaguchi are silent in teaching wherein the significant degree of elevation of the nitric oxide concentration restricted to the large intestine is indicative of Ulcerative Colitis, the significant degree of elevation of the nitric oxide concentration throughout the gastrointestinal tract of the subject, not restricted to the large intestine, is indicative of Crohn's Disease. Kimura teaches wherein the significant degree of elevation of the nitric oxide concentration restricted to the large intestine is indicative of Ulcerative Colitis, the significant degree of elevation of the nitric oxide concentration throughout the gastrointestinal tract of the subject, not restricted to the large intestine, is indicative of Crohn's Disease (Kimura | Page 1 – Abstract). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul, Jones, Rabinovitz, Gerlinger, Tsutsumi, Gobert, and Sakaguchi to incorporate the teachings of nitric oxide concentrations within the GI track from Kimura because the high nitric oxide (NO) concentrations in the colon can be an indicator of either Ulcerative Colitis or Crohn's Disease. If lab results show NO values above the standard range, a physician can use this information to help the patient manage their condition through dietary or lifestyle adjustments and by providing appropriate treatment (Kimura | Page 1 – Abstract).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Palti in view of Altschul, Jones, Rabinovitz, Gerlinger, Tsutsumi, Gobert, Sakaguchi, and Hubbard et al. (US 20040077965 A1).
Regarding Claim 11, Palti in view of Altschul, Jones, Rabinovitz, Gerlinger, Tsutsumi, Gobert, and Sakaguchi teaches the method according to claim 9. Palti teaches the sensor (Palti | image sensor – element 24) within the smart pill (Palti | in vivo device – element 10).
Palti teaches a sensor within a smart pill but is silent in teaching the sensor is two or more sensors that measures a concentration of two or more analytes. Altschul teaches two or more sensors that measures a concentration of two or more analyte concentrations (Altschul | sensors – element 22; Paragraph 0088, 0140). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti to incorporate the teachings of two or more sensors measuring two or more analytes within the subject’s digestive tract from Altschul because the plurality of sensors, within the smart pill, allows for the pill to detect for the presence of drug overdose or abuse by measuring for analyte changes within the user’s digestive tract. (Altschul | Paragraphs 0021-0023).
Palti in view of Altschul, Jones, Rabinovitz, Gerlinger, Gobert, and Sakaguchi are silent in teaching correlating the degree of elevation of ammonium ion concentration to a level of protein fermentation; and assessing the gut health of the subject based on the level of protein fermentation, wherein a significant degree of elevation of the ammonium ion concentration indicates a high level of protein fermentation, a non-significant degree of elevation of the ammonium ion concentration indicates a low level of protein fermentation, and/or a positive degree of elevation of the ammonium ion concentrations compared to the reference value indicates an increased level of protein fermentation and a negative degree of elevation of the ammonium ion concentration compared to the reference value indicates a decreased level of protein fermentation. Tsutsumi teaches correlating the degree of elevation of ammonium ion concentration to a level of protein fermentation (Tsutsumi | Paragraph 0020); and assessing the gut health of the subject based on the level of protein fermentation, wherein a significant degree of elevation of the ammonium ion concentration indicates a high level of protein fermentation (Tsutsumi | Paragraph 0020), a non-significant degree of elevation of the ammonium ion concentration indicates a low level of protein fermentation (Tsutsumi | Paragraph 0020; [Examiner’s note, the correlation between ammonium ion concentrations and protein fermentation is a linear relation. If there is high putrefaction, protein fermentation, then there will be high presence of ammonium ion concentration. If there is low putrefaction, then there will be low presence of ammonium ion concentration.]), and/or a positive degree of elevation of the ammonium ion concentrations compared to the reference value indicates an increased level of protein fermentation and a negative degree of elevation of the ammonium ion concentration compared to the reference value indicates a decreased level of protein fermentation [Examiner' s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.]. One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul, Jones, Rabinovitz, Gerlinger, Gobert, and Sakaguchi to incorporate the teachings of the linear relationship between protein fermentation and ammonium ion concentration from Tsutsumi because a detection of high amounts of ammonium ion concentrations within the patient can deteriorate their health and cause an illness (Tsutsumi | Paragraph 0020, it is known that increase of the blood ammonia concentration causes emesis, fever or pyrexia, and in serious cases, hepato celebral encephalopathy).
Palti in view of Altschul, Jones, Rabinovitz, Gerlinger, Tsutsumi, Gobert, and Sakaguchi are silent in teaching wherein assessing the gut health of the subject based on the measured concentrations of the analytes by the sensors comprises: determining a degree of elevation of the ammonium ion concentration in the gastrointestinal tract of the subject by comparing the measured ammonium ion concentration to a reference value (Hubbard | Paragraphs 0018-0020). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Jones, Rabinovitz, Kahn, Tsutsumi, Gobert, and Sakaguchi teaches to incorporate the teachings of an ammonium sensor from Hubbard because the ammonium sensor is used as a key indicator for the presence of H. pylori. The baseline provides the physician information regarding the current environment of the patient’s stomach before the administration of urea. The before and after ammonia concentration differences will allow the physician to determine whether the patient has the H. pylori bacteria (Hubbard | Paragraph 0035).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Palti in view of Altschul, Jones, Rabinovitz, and Betesh et al. (US 20070156016 A1).
Regarding Claim 14, Palti in view of Altschul, Jones, and Rabinovitz teaches the smart pill according to claim 13. Palti in view of Altschul, Jones, and Rabinovitz is silent in teaching further comprising one or more additional sensor, wherein said additional sensor is able to correct for interference of other compounds present inside the gastrointestinal tract of the subject. Betesh teaches further comprising one or more additional sensor, wherein said additional sensor is able to correct for interference of other compounds present inside the gastrointestinal tract of the subject (Betesh | interference sensor – element 160; Paragraph 0003). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the smart pill of Palti in view of Altschul, Jones, and Rabinovitz to incorporate the teachings of additional sensors to measure for interference from Betesh because the additional sensors are used to measure and remove background noise, signal drift, and other environmental interferences, which provides accurate raw signals and enables reliable data collection (Betesh | Paragraph 0025).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Palti in view of Altschul, Jones, Rabinovitz, and Gerlinger et al. (US 20200200654 A1).
Regarding Claim 16, Palti in view of Altschul, Jones, and Rabinovitz teaches the method according to claim 1. Palti in view of Altschul, Jones, and Rabinovitz are silent in teaching the non-degradable permeable polymeric membrane is configured to selectively bind to ammonium ions. Gerlinger teaches the non-degradable permeable polymeric membrane is configured to selectively bind to ammonium ions (Gerlinger | Paragraph 0073). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensors within the smart pill of Palti in view of Altschul, Jones, and Rabinovitz to incorporate the teachings of an ion-selective electrode from Gerlinger because the ion-selective electrode allows for measuring specific analytes within an unknown environment. For example, the ion-selective electrode from Gerlinger teaches measuring ammonium within a liquid sample of an unknown composition (Gerlinger | Paragraph 0073).
Regarding Claim 17, Palti in view of Altschul, Jones, and Rabinovitz teaches the smart pill according to claim 13. Palti in view of Altschul, Jones, and Rabinovitz are silent in teaching the non-degradable permeable polymeric membrane is configured to selectively bind to ammonium ions. Gerlinger teaches the non-degradable permeable polymeric membrane is configured to selectively bind to ammonium ions (Gerlinger | Paragraph 0073). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensors within the smart pill of Palti in view of Altschul, Jones, and Rabinovitz to incorporate the teachings of an ion-selective electrode from Gerlinger because the ion-selective electrode allows for measuring specific analytes within an unknown environment. For example, the ion-selective electrode from Gerlinger teaches measuring ammonium within a liquid sample of an unknown composition (Gerlinger | Paragraph 0073).
Response to Arguments
The applicant’s argument and amendment filed 01/09/2023 have been fully considered.
The applicant’s amendments to the abstract have overcome the specification objection, the claim objections, and the 35 U.S.C. 112b and 112d rejections.
Regarding the 35 U.S.C 101 Rejection, the amendments to the claims do not overcome the rejection because the claims meet Step 2A Prong 1, Step 2B Prong 2, and Step 2B. The amended claims meet Step 2A Prong 1 because the claims discuss instructions on detecting the presence of H. pylori within the user’s digestive system; the claims are read as a mental process. The amended claims meet Step 2A Prong 2 because the abstract idea in each of independent claims are not integrated into a practical application, refer to Step 2A, Prong 2 for further clarification. Lastly, the amended claims meet Step 2B because the additional elements of smart pill, two or more sensors, a reference electrode, pH sensor, ammonium sensor, and nitric oxide sensor; are well-known, routine, and conventional as taught in US Reference 20050179805 A1, US Reference 20160045656 A1, US Reference 4790925 A, and US Reference 4824561 A; the additional elements of power source, a communication interface, electronic circuits, base device, processing device, and cloud are generically claimed computer components.
Regarding the 35 U.S.C. 103 Rejection, the examiner agrees that prior art cited in the nonfinal office action filed on 10/17/2025 does not teach the claim limitations found in the amended claims. Due to the scope changes from the amended claims, further search and consideration was required. New references, Altschul et al. (US 20150343144 A1), and Gerlinger et al. (US 20200200654 A1), are used to modify the smart pill of Palti. Please refer to the 35 U.S.C 103 Rejection for further clarification.
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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/SRISTI DIVINA GOMES/Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
