DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Objections
Claims 1, 2, 4-9, 11-15 are objected to because of the following informalities:
Regarding claims 1, 2, 4-9, 11-15, remove the following elements from the claims: S0, S1, S2, S21, S210, S22, S220A, S2201, S2202, S23A, S23B, S24, S25A, S25B, S3, S310A, S31A, S31B, S4, S5, S5, S51A, S51B1, S51B2, S510A2, S52, S521, S522, S5210B, S53, S53A, S530A, S532B, S533A, S534A, 10, 20, 40, 50, 60, 70.
Regarding claims 4, 6, and 8, “The method according to anyone of claims 2” should read “The method according to claim 2.”
Regarding claim 9, “the smart pill comprises a nitric oxide sensor” should read “the smart pill comprises the nitric oxide sensor.”
Regarding claim 10, “the measured nitric oxide concentrations to a predetermined threshold” should read “the measured nitric oxide concentrations to the predetermined threshold.”
Regarding claim 11, “the smart pill comprises an ammonium ion sensor” should read “the smart pill comprises the ammonium ion sensor.”
Regarding claim 15, in light of the 112b below: Applicant is advised that should claim 1 be found allowable, claim 15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Appropriate correction is required.
The claims are objected to because the lines are crowded too closely together, making reading difficult. Substitute claims with lines one and one-half or double spaced on good quality paper are required. See 37 CFR 1.52(b).
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 1-15 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.
In Claim 1, 3, and 15, the claim limitation “two or more sensors” and “each sensor” and “the sensors” renders the claim indefinite because the limitation is unclear. It is unclear whether these sensors are the same or different. For purposes of examination, the claim limitation “each sensor” is interpreted as “each of the two or more sensors,” and “sensors” is interpreted as “the two or more sensors.”
In Claim 1 and 15, the claim limitation “measuring concentrations of analytes” and “measuring a concentration of an analyte” renders the claim indefinite because the limitation is unclear. It is unclear regarding the following: if “a concentration of an analyte” is meant to refer back to “concentrations of analytes” or not; if “a concentration of two or more analytes” is meant to refer back to “concentrations of analytes.” For purposes of examination, the claim limitation is interpreted as “measuring concentrations of analytes” and “measuring a concentrations of two or more analytes.”
In Claim 1 and 15, the claim limitation “analyte” and “analytes” and “one analyte” renders the claim indefinite because the limitation is unclear. It is unclear whether one analyte is measured or two or more analyte are measured. For purposes of examination, the claim limitations for “analyte,” “analytes,” and “one analyte” are interpreted as “analytes.”
In Claim 1 and 15, the claim limitation “the measured concentrations” renders the claim indefinite because the limitation lacks proper antecedent basis. For purposes of examination, the indefinite limitation is interpreted as “the concentrations of the two or more.”
In Claim 2, the claim limitation “the measured analyte concentrations” renders the claim indefinite because the limitation lacks proper antecedent basis. For purposes of examination, the indefinite limitation interpreted as “a measured analyte concentrations.”
In Claim 2, the claim limitation “the measured concentrations of analytes” renders the claim indefinite because the limitation is unclear. It is unclear whether the analytes are referring to two or more analytes as discloses in Claim 1. For purposes of examination, the claim limitation is interpreted as “the concentrations of the two or more analytes.”
In Claim 3, the claim limitation “said sensors” renders the claim indefinite because the limitation lacks proper antecedent basis. For purposes of examination, the indefinite limitation interpreted as “said two or more sensors.”
In Claim 9, the claim limitation “the presence or absence of ulcers and/or inflammation” renders the claim indefinite because the limitation lacks proper antecedent basis. For purposes of examination, the indefinite limitation is interpreted as “a presence or absence of ulcers and/or inflammation.”
In Claim 10, the claim limitation “the stomach, the small intestine and the large intestine” renders the claim indefinite because the limitation lacks proper antecedent basis. For purposes of examination, the indefinite limitation interpreted as “a stomach, a small intestine and a large intestine.”
In Claim 13, the claim limitation “the sensors” renders the claim indefinite because the limitation lacks proper antecedent basis. For purposes of examination, the indefinite limitation interpreted as “the two or more sensors.”
In Claim 15, the claim limitation “The smart pill (10) according to claims 13, configured to perform a method for measuring concentrations of analytes in a gastrointestinal tract of a subject, the method comprising:” renders the claim indefinite because the limitation is unclear. It is unclear what the intended statutory category is. Claim 15 is dependent on claim 13 which is a device, and claim 15 appears to be a method. For purposes of examination, the claim limitation is interpreted as “A method for measuring concentrations of analytes in a gastrointestinal tract of a subject, the method comprising:”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends; Claim 15 is a duplicate of Claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Applicant is advised that should claim 1 be found allowable, claim 15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 101
Claims 2, 4-11 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 2, 4-11 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 2, 4-11 recites at least one step or instruction for determining whether the patient has a Helicobacter pylori infection 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 2, 4-11 recites an abstract idea.
Specifically, Claim 2 recites “The method according to claim 1, further comprising assessing gut health of the subject based on the measured analyte concentrations by: transmitting (S4) the measured concentrations of analytes from the base device to a processing device or a cloud; and assessing (S5), gut health of the subject based on the measured concentrations of analytes of the two or more sensors using the processing device or cloud.”
Further, dependent Claims 4-11 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Specifically, dependent claim 4 recites, “The method according to anyone of claims 2, wherein the subject is suspected to be suffering from a Helicobacter pylori infection and the smart pill comprises an ammonium sensor for measuring ammonium ion concentrations as a concentration of one analyte, wherein the measuring (S2) a concentration of the two analytes and transmitting (S3) the measured concentrations comprises: continuously measuring (S21), using the pH sensor, hydrogen ion concentrations to determine a location of the smart pill in the gastrointestinal tract; determining (S22), based on the measured hydrogen ion concentrations, that the smart pill has reached a stomach of the subject; measuring (S23A), using the ammonium sensor, a baseline ammonium ion concentration; orally administering (S24) a predetermined amount of urea to the subject; continuously measuring (S25A), using the ammonium sensor, ammonium ion concentrations after administration of urea; and continuously transmitting (S31A), using the communication interface, the measured concentrations from the two sensors to the base device.”
Dependent claim 5 recites, “The method according to claim 4, wherein assessing (S5) gut health of the subject based on the measured analyte concentrations comprises: determining (S51A) a degree of elevation of ammonium ion concentrations in the gastrointestinal tract by subtracting the baseline ammonium ion concentration from the measured ammonium ion concentrations after administration of urea; correlating (S52) the degree of elevation of ammonium ion concentrations to the presence or absence of Helicobacter pylori activity in the stomach of the subject; and assessing (S53) gut health of the subject based on the presence or absence of Helicobacter pylori activity, wherein a significant degree of elevation is correlated with the presence of Helicobacter pylori activity and wherein a non-significant degree of elevation or lack of elevation is correlated with the absence of Helicobacter pylori activity.”
Dependent claim 6 recites, “The method according to anyone of claims 2, wherein the subject is suspected to be suffering from a Helicobacter pylori infection and the smart pill comprises an ammonium sensor for measuring ammonium ion concentrations as a concentration of one analyte and a nitric oxide sensor for measuring nitric oxide concentrations as a concentration of one analyte, wherein the measuring (S2) a concentration of the three analytes and transmitting (S3) the measured concentrations comprises: continuously measuring (S21), using the pH sensor, hydrogen ion concentrations to determine a location of the smart pill in the gastrointestinal tract; determining (S22), based on the measured hydrogen ion concentration, that the smart pill has reached a stomach of the subject; measuring (S23B), using the ammonium sensor, a baseline ammonium ion concentration; orally administering (S24) a predetermined amount of urea to the subject; continuously measuring (S25B), using the ammonium sensor and nitric oxide sensor, respectively, ammonium ion concentrations and nitric oxide concentrations after administration of urea; and continuously transmitting (S31 B), using the communication interface, the measured concentrations from the three sensors to the base device.”
Dependent claim 7 recites, “The method according to claim 6, wherein assessing (S5) gut health of the subject based on the measured analyte concentrations comprises: determining (S51B1) a degree of elevation of ammonium ion concentrations in the gastrointestinal tract by subtracting the baseline ammonium ion concentration from the measured ammonium ion concentrations after administration of urea and determining (S51 B2) a degree of elevation of nitric oxide concentrations in the gastrointestinal tract by comparing the measured nitric oxide concentrations to a predetermined threshold; correlating (S521) the degree of elevation of ammonium ion concentrations to the presence or absence of Helicobacter pylori activity in the stomach of the subject; correlating (S522) the degree of elevation of nitric oxide concentrations to the presence or absence of ulcers and/or inflammation, wherein a measured concentration of nitric oxide being above or equal to the predetermined threshold is considered as a significant degree of elevation; and assessing (S53B) gut health based on the presence or absence of Helicobacter pylori activity and ulcers and/or inflammation, wherein (S531A) 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 (S532A) 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 (S533A) 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 (S534A) 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.”
Dependent claim 8 recites, “The method according to anyone of claims 2, wherein the subject is suffering from, or is suspected to be suffering from, inflammatory bowel disease and/or suspected of presenting increased protein fermentation, and the smart pill comprises a nitric oxide sensor for measuring nitric oxide concentrations or an ammonium sensor for measuring ammonium ion concentrations as a concentration of one analyte, wherein the measuring (S2) a concentration of the two analytes and transmitting (S3) the measured concentrations comprises: continuously measuring (S210), using the pH sensor, hydrogen ion concentrations to determine, based on the hydrogen ion concentrations and a time that has passed from oral administration of the smart pill, a location of the smart pill in the gastrointestinal tract; continuously measuring (S220A), using the nitric oxide sensor or ammonium sensor, nitric oxide concentrations or ammonium ion concentrations as the smart pill travels through the gastrointestinal tract, wherein said measuring includes measuring in stomach (S2201), measuring in small intestine (S2202) and measuring in large intestine (S2203); continuously transmitting (S31OA), using the communication interface, the measured concentrations from the two sensors to the base device.”
Dependent claim 9 recites, “The method according to claim 8, wherein the smart pill comprises a nitric oxide sensor and wherein assessing (S5) gut health of the subject based on the measured analyte concentrations comprises: determining (S510A1) a degree of elevation of nitric oxide concentrations in the gastrointestinal tract by comparing the measured nitric oxide concentrations to a predetermined threshold; correlating (S521 OA) the degree of elevation of nitric oxide concentrations to the presence or absence of ulcers and/or inflammation, wherein a measured concentration of nitric oxide being above or equal to the predetermined threshold is considered as a significant degree of elevation; and assessing (S530A) gut health based on the presence or absence of ulcers and/or inflammation, wherein a significant degree of elevation nitric oxide concentrations are correlated with the presence of ulcers and/or inflammation, and wherein a non-significant degree of elevation of nitric oxide concentrations are correlated with the absence of ulcers and inflammation.”
Dependent claim 10 recites, “The method according to claim 9, wherein determining (S510A1) a degree of elevation of nitric oxide concentrations in the gastrointestinal tract by comparing the measured nitric oxide concentrations to a predetermined threshold is performed at different locations in the gastrointestinal tract of the subject, including the stomach, the small intestine and the large intestine, and wherein a significant degree of elevation of nitric oxide concentrations restricted to the large intestine is indicative of Ulcerative Colitis, a significant degree of elevation of nitric oxide concentrations throughout the gastrointestinal tract, not restricted to the large intestine, is indicative of Crohn's Disease.”
Dependent claim 11 recites, “The method according to claim 9, wherein the smart pill comprises an ammonium ion sensor and wherein assessing (S5) gut health of the subject based on the measured analyte concentrations comprises: determining (S510A2) a degree of elevation of ammonium ion concentrations in the gastrointestinal tract by comparing the measured ammonium ion concentrations to a reference value; correlating (S5210B) the degree of elevation of ammonium ion concentrations to a level of protein fermentation; and assessing (S530A) gut health based on the level of protein fermentation, wherein a significant degree of elevation of ammonium ion concentrations indicates a high level of protein fermentation, a non-significant degree of elevation of ammonium ion concentrations indicates a low level of protein fermentation, and/or a positive degree of elevation of ammonium ion concentrations compared to the reference value indicates an increased level of protein fermentation and a negative degree of elevation of ammonium ion concentrations compared to the reference value indicates a decreased level of protein fermentation.”
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in each of Claims 2, 4-11 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in Claims 2, 4-11), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: orally administering a smart pill, measuring analyte concentrations from two/three or more sensors, reference electrode, power source, transmitting the data collected through communication interface, electronic circuits, base device, processing device, cloud, nitric oxide sensor, ammonium sensor, pH sensor are generically recited computer elements in Claims 2, 4-11 which do not improve the functioning of a computer, or any other technology or technical field. The limitations of claim 1 merely indicate a field of use and are necessary extra-solutionary data gathering. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in Claims 2, 4-11 is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., processing device and cloud as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in Claims 2, 4-11 is not integrated into a practical application under the 2019 PEG.
Accordingly, Claims 2, 4-11 are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 2, 4-11 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: orally administering a smart pill, measuring analyte concentrations from two/three or more sensors, reference electrode, power source, transmitting the data collected through communication interface, electronic circuits, base device, processing device, cloud, nitric oxide sensor, ammonium sensor, pH sensor.
The above-identified additional elements 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.
Per Applicant’s specification, orally administering a smart pill is swallowed by the patient and assesses for H. pylori activity through the various sensors to collect raw data from the GI track (Paragraph 0049-0050); measuring analyte concentrations from two/three or more sensors are used to collect raw data signals from the GI, the sensors include a nitric oxide sensor, ammonium sensor, and pH sensor (Paragraphs 0049-0050); reference electrode provides baseline signals from the environment, GI tract, and does not interact with the analytes (Paragraph 0073); power source is a battery that powers the smart pill (Paragraph 0089); transmitting the data collected through communication interface is an audio-visual interface that displays the data collected by the smart pill (Paragraph 0073); electronic circuits connects the sensors and reference electrode (Paragraph 0006); base device receives the raw data signals from the sensors (Paragraph 0035, The concentrations may be measured indirectly, by measuring for example a raw potential or current in the sensor, which may be correlated to a concentration. In this case the raw data signal (potential/current) is transmitted from the sensors to the base device); processing device receives measured concentrations from the base device (Paragraph 0004, transmitting the measured concentrations from the base device to a processing device or a cloud infrastructure, and assessing gut health of the subject based on the measured concentrations of analytes of the two or more sensors using the processing device or cloud); cloud is used to communicate information from the base device to the processing device (Paragraph 0049, the processing device 75 may be communicatively coupled to the base device 70, e.g. via the cloud).
Accordingly, in light of Applicant’s specification, the claimed term communication interface, processing device, base device, and cloud are reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the processing device, base device, and cloud. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 2, 4-11 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the method of Claims 2, 4-11 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 2, 4-11 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in Claims 2, 4-11 do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. The limitations of claim 1 merely indicate a field of use and are necessary extra-solutionary data gathering. Thus, Claims 2, 4-11 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 2, 4-11 amounts to significantly more than the abstract idea itself. Accordingly, Claims 2, 4-11 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, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Palti et al. (US 20060052667 A1) in view of Jones et al. (US 20200262908 A1), Rabinovitz et al. (US 20140316222 A1), and Kahn et al. (US 20120187000 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, An imaging system may include an illumination unit 23, typically comprising a plurality of illumination sources such as white LEDs, an image sensor 24, such as a CMOS or CCD, an optical system (not shown) for focusing an image onto the image sensor, a transmitter 26 for transmitting, such as by RF, image signals of the image sensor 24, and a power source 25, such as a silver oxide battery, that provides power to electrical elements of the imaging device), wherein the sensor is a pH sensor (image sensor – element 24) for measuring hydrogen ion concentrations as a concentration of one analyte (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); and
transmitting (S3), using the communication interface (transmitter – element 26; Paragraph 0016), the measured concentrations from the sensor to a base device (receiving unit – element 1000) located outside of a body of the subject (Paragraphs 0022-0024).
Palti is silent in disclosing the smart pill comprising one or more sensors; each sensor 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; measuring (S2) a concentration of one or more analytes using the one or more sensors; and wherein 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 teaches the smart pill (Jones | ingestible device – element 100) comprising one or more sensors (Jones | 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;);
each sensor being able to measure a concentration of an analyte in the gastrointestinal tract of the subject (Jones | Paragraph 0365), wherein the one or more sensors measure different analytes (Jones | 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;);
measuring (S2) a concentration of one or more analytes (Jones | Paragraph 0211) using the two or more sensors (Jones | 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;)
and wherein 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 to incorporate the teachings of a smart pill containing one or more 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 (Jones | Paragraph 0005).
Additionally, Palti in view of 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 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).
In the teachings of Rabinovitz regarding Palti in view of Jones and Rabinovitz, discusses the smart pill containing a reference and working electrode, but they are silent in teaching two or more sensors/electrodes that collect analyte concentrations;
Kahn teaches two or more sensors that collect different analyte concentrations (Kahn | Paragraph 0237-0238). 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 Rabinovitz to incorporate the teachings of two or more working electrodes from Kahn because measuring two different analyte concentrations simultaneously provides a comprehensive and accurate data collection for diagnosing a disease or disorder, and improves diagnostic accuracy within a complex environment, like the GI Track for determining whether a patient may or may not have H. pylori (Kahn | Paragraph 0143, 0234).
Regarding Claim 2, Palti in view of Jones, Rabinovitz, and Kahn teaches the method according to claim 1, further comprising assessing gut health of the subject based on the measured analyte concentrations by:
transmitting (S4) the measured concentrations of 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 in view of Jones and Rabinovitz is silent in teaching assessing (S5), gut health of the subject based on the measured concentrations of analytes of the two or more sensors using the processing device or cloud; Jones teaches assessing (S5), gut health of the subject based on the measured concentrations of analytes of the one or more 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 Jones, Rabinovitz, and Kahn 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).
In the teachings of Rabinovitz regarding Palti in view of Jones, Rabinovitz, and Kahn, discusses the smart pill containing a reference and working electrode, but they are silent in teaching two or more sensors/electrodes that collect analyte concentrations;
Kahn teaches two or more sensors that collect different analyte concentrations (Kahn | Paragraph 0237-0238). 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 Kahn to incorporate the teachings of two or more working electrodes from Kahn because measuring two different analyte concentrations simultaneously provides a comprehensive and accurate data collection for diagnosing a disease or disorder, and improves diagnostic accuracy within a complex environment, like the GI Track for determining whether a patient may or may not have H. pylori (Kahn | Paragraph 0143, 0234).
Regarding Claim 12, Palti in view of Jones, Rabinovitz, and Kahn teaches the method according to claim 1. Palti in view of Jones, Rabinovitz, and Kahn fail to teach calibrating (SO) the two or more sensors before oral administration to the subject;
Rabinovitz teaches calibrating (SO) the one or more sensors before oral administration to the subject (Rabinovitz | Paragraph 0862, the ingestible device is individually calibrated (for example, by comparing to a positive or negative control as described herein), wherein the fluorescent properties of the absorbable sponge held in the sampling chamber of the device are determined prior to the introduction of the sample. The ingestible device as described herein is useful for detecting or quantifying viable bacterial cells in vivo.). 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 Kahn 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, the ingestible device is individually calibrated (for example, by comparing to a positive or negative control as described herein), wherein the fluorescent properties of the absorbable sponge held in the sampling chamber of the device are determined prior to the introduction of the sample. The ingestible device as described herein is useful for detecting or quantifying viable bacterial cells in vivo.).
In the teachings of Rabinovitz regarding Palti in view of Jones, Rabinovitz and Kahn, discusses the smart pill containing a reference and working electrode, but they are silent in teaching two or more sensors/electrodes that collect analyte concentrations;
Kahn teaches two or more sensors that collect analyte concentrations (Kahn | Paragraph 0237). 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 Kahn to incorporate the teachings of two or more working electrodes from Kahn because the working electrode, along with the reference electrode, measures target analyte concentrations (Kahn | Paragraph 0143).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Palti et al. (US 20060052667 A1) in view of Jones et al. (US 20200262908 A1), Rabinovitz et al. (US 20140316222 A1), Kahn et al. (US 20120187000 A1), and Bulitta et al. (US 20110092787 A1).
Regarding Claim 3, Palti in view of Jones, Rabinovitz and Kahn teaches the method according to claim 1, wherein the smart pill (Palti | in vivo device – element 10) comprises the sensors (Palti | Paragraph 0007). a non-degradable permeable polymeric membrane, said membrane enabling continuous and/or repeated measurements using said sensors.
Palti in view of Jones, Rabinovitz and Kahn, discusses the smart pill containing a reference and working electrode, but they are silent in teaching two or more sensors/electrodes that collect analyte concentrations;
Kahn teaches two or more sensors that collect analyte concentrations (Kahn | Paragraph 0237-0238). 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 Kahn to incorporate the teachings of two or more working electrodes from Kahn because the working electrode, along with the reference electrode, measures target analyte concentrations (Kahn | Paragraph 0143).
Lastly, Palti in view of Jones, Rabinovitz, and Kahn is silent in teaching at least one of the sensors comprising a non-degradable membrane; membrane enabling continuous and/or repeated measurements using said sensors;
Bulitta teaches sensors comprising a non-degradable membrane (Bulitta | Paragraph 0026, 0040); membrane enabling continuous and/or repeated measurements using said sensors (Bulitta | Paragraph 0016). 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 Kahn to incorporate the teachings of a non-degradable membrane. Doing so will prevent the erosion of the sensors from the patient's GI tract, which is typically an acidic environment. The semipermeable aspect of the membrane allows for the sensor to measure target analyte concentrations (Bulitta | Paragraphs 0026, 0040, 0044).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Palti et al. (US 20060052667 A1) in view of Jones et al. (US 20200262908 A1), Rabinovitz et al. (US 20140316222 A1), Kahn et al. (US 20120187000 A1), Bulitta et al. (US 20110092787 A1), and Hubbard et al. (US 20040077965 A1).
Regarding Claim 4, Palti in view of Jones, Rabinovitz, and Kahn teaches the method according to anyone of claims 2, 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); orally administering (S24) a predetermined amount of urea to the subject (Palti | Paragraph 0014, 0027);
Palti in view of Jones, Rabinovitz, and Kahn is silent in teaching continuously measuring (S21), using the pH sensor, hydrogen ion concentrations to determine a location of the smart pill in the gastrointestinal tract; determining (S22), based on the measured hydrogen ion concentrations, that the smart pill has reached a stomach of the subject;
Jones teaches continuously measuring (S21), using the pH sensor, hydrogen ion concentrations 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 (S22), based on the measured hydrogen ion concentrations, that the smart pill has reached a stomach of the subject (Jones | Paragraph 0365, ingestible device 300 may be configured to determine whether it has entered stomach 306 based at least in part on a plurality of parameters, such as but not limited to the use of light or temperature measurements (e.g., via detector 122 (FIG. 2) or via a thermometer within ingestible device 300), pH measurements (e.g., via a pH meter within ingestible device 300), time measurements (e.g., as detected through the use of clock circuitry included within PCB 120 (FIG. 2)), or any other suitable information).
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 Kahn 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).
Additionally, Palti in view of Jones, Rabinovitz, and Kahn is silent in teaching wherein the measuring (S2) a concentration of the two analytes and transmitting (S3) the measured concentrations; continuously measuring (S25A), using the ammonium sensor, ammonium ion concentrations after administration of urea; continuously transmitting (S31A), using the communication interface, the measured concentrations from the two sensors to the base device;
Rabinovitz teaches wherein the measuring (S2) a concentration of the two analytes and transmitting (S3) the measured concentrations (Rabinovitz | Paragraph 0037); continuously measuring (S25A), using the ammonium sensor, ammonium ion concentrations after administration of urea (Rabinovitz | Paragraph 0036); continuously transmitting (S31A), using the communication interface (Rabinovitz | display unit – element 18), the measured concentrations 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 Jones, Rabinovitz, and Kahn 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).
In the teachings of Rabinovitz regarding Palti in view of Jones, Rabinovitz and Kahn, discusses the smart pill containing a reference and working electrode, but they are silent in teaching two sensors/electrodes that collect analyte concentrations;
Kahn teaches two electrodes that collect analyte concentrations (Kahn | Paragraph 0237-0238). 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 Kahn to incorporate the teachings of two or more working electrodes from Kahn because the working electrode, along with the reference electrode, measures target analyte concentrations (Kahn | Paragraph 0143).
Palti in view of Jones, Rabinovitz, and Kahn is silent in teaching an ammonium sensor in the smart pill that measures ammonium within the GI track; ammonium sensor for measuring ammonium ion concentrations as a concentration of one analyte;
Bulitta teaches an ammonium sensor in the smart pill (Bulitta | endocapsule – element 2) that measures ammonium within the GI track (Bulitta | Paragraph 0026, 0030, 0040); ammonium sensor for measuring ammonium ion concentrations as a concentration of one analyte (Bulitta | Paragraphs 0039-0040). 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 Kahn to incorporate the teachings of an ammonium sensor in a smart capsule from Bulitta because the detection of ammonia within the GI tract is used as a key indicator for the presence or absence of H. pylori (Bulitta | Paragraph 0026).
Lastly, Palti in view of Jones, Rabinovitz, Kahn and Bulitta is silent in teaching measuring (S23A), using the ammonium sensor, a baseline ammonium ion concentration;
Hubbard teaches measuring (S23A), 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 Jones, Rabinovitz, Kahn and Bulitta 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 Jones, Rabinovitz, Kahn, Bulitta, and Hubbard the method according to claim 4. Palti in view of Jones, Rabinovitz, Kahn, Bulitta, and Hubbard is silent in teaching all of the claim limitations within claim 5.
Hubbard teaches wherein assessing (S5) gut health of the subject based on the measured analyte concentrations comprises:
determining (S51A) a degree of elevation of ammonium ion concentrations in the gastrointestinal tract by subtracting the baseline ammonium ion concentration from the measured ammonium ion concentrations after administration of urea (Hubbard | Table 2; Figure 4; Paragraphs 0073-0076);
correlating (S52) the degree of elevation of ammonium ion concentrations to the presence or 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 (S53) gut health of the subject based on the presence or absence of Helicobacter pylori activity, wherein a significant degree of elevation is correlated with the presence of Helicobacter pylori activity and wherein a non-significant degree of elevation or lack of elevation 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 Jones, Rabinovitz, Kahn, Bulitta, and Hubbard 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 et al. (US 20060052667 A1) in view of Jones et al. (US 20200262908 A1), Rabinovitz et al. (US 20140316222 A1), Kahn et al. (US 20120187000 A1), Bulitta et al. (US 20110092787 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).
Regarding claim 6, Palti in view of Jones, Rabinovitz, and Kahn teaches the method according to anyone of claims 2, wherein the subject is suspected to be suffering from a Helicobacter pylori infection (Palti | Paragraph 0014, 0027) and the smart pill (Palti | in vivo device – element 10); orally administering (S24) a predetermined amount of urea to the subject (Palti | Paragraph 0014, 0027).
Palti in view of Jones, Rabinovitz, and Kahn is silent in teaching continuously measuring (S21), using the pH sensor, hydrogen ion concentrations to determine a location of the smart pill in the gastrointestinal tract; determining (S22), based on the measured hydrogen ion concentration, that the smart pill has reached a stomach of the subject;
Jones teaches continuously measuring (S21), using the pH sensor, hydrogen ion concentrations 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 (S22), based on the measured hydrogen ion concentration, that the smart pill has reached a stomach of the subject (Jones | Paragraph 0365, ingestible device 300 may be configured to determine whether it has entered stomach 306 based at least in part on a plurality of parameters, such as but not limited to the use of light or temperature measurements (e.g., via detector 122 (FIG. 2) or via a thermometer within ingestible device 300), pH measurements (e.g., via a pH meter within ingestible device 300), time measurements (e.g., as detected through the use of clock circuitry included within PCB 120 (FIG. 2)), or any other suitable information).
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 Kahn 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).
Additionally, Palti in view of Jones, Rabinovitz, and Kahn is silent in teaching wherein the measuring (S2) a concentration of the one or more analytes and transmitting (S3) the measured concentrations; continuously transmitting (S31 B), using the communication interface, the measured concentrations from the one or more sensors to the base device; continuously measuring (S25B), using the ammonium sensor, respectively, ammonium ion concentrations after administration of urea; continuously transmitting (S31 B), using the communication interface, the measured concentrations from the one or more sensors to the base device;
Rabinovitz teaches wherein the measuring (S2) a concentration of the one or more analytes and transmitting (S3) the measured concentrations (Rabinovitz | Paragraph 0037);
continuously transmitting (S31 B), using the communication interface (Rabinovitz | display unit – element 18), the measured concentrations from the three sensors to the base device (Rabinovitz | Paragraph 0037).
continuously measuring (S25B), using the ammonium sensor (Rabinovitz | Paragraph 0036), respectively, ammonium ion concentrations after administration of urea (Rabinovitz | Paragraph 0036); and
continuously transmitting (S31 B), using the communication interface (Rabinovitz | display unit – element 18), the measured concentrations from the one or more 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 Jones and Rabinovitz 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).
In the teachings of Rabinovitz regarding Palti in view of Jones, Rabinovitz and Kahn, discusses the smart pill containing a reference and working electrode, but they are silent in teaching three sensors/electrodes that collect three analyte concentrations;
Kahn teaches three electrodes that collect three analyte concentrations (Kahn | Paragraph 0237-0238, 0395). 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 Kahn to incorporate the teachings of two or more working electrodes from Kahn because the working electrode, along with the reference electrode, measures target analyte concentrations (Kahn | Paragraph 0143).
Additionally, Palti in view of Jones, Rabinovitz, and Kahn is silent in teaching the smart pill comprises an ammonium sensor for measuring ammonium ion concentrations as a concentration of one analyte;
Bulitta teaches the smart pill (Bulitta | endocapsule – element 2) comprises an ammonium sensor for measuring ammonium ion concentrations as a concentration of one analyte (Bulitta | Paragraph 0026, 0030, 0039-0040). 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 Kahn to incorporate the teachings of an ammonium sensor in a smart capsule from Bulitta because the detection of ammonia within the GI tract is used as a key indicator for the presence or absence of H. pylori (Bulitta | Paragraph 0026).
Lastly, Palti in view of Jones, Rabinovitz, Kahn, and Bulitta is silent in teaching measuring (S23A), using the ammonium sensor, a baseline ammonium ion concentration;
Hubbard teaches measuring (S23A), 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 Jones, Rabinovitz, and Bulitta 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).
Lastly, Palti in view of Jones, Rabinovitz, Jones, Rabinovitz, Kahn, Bulitta, and Hubbard is silent in teaching a nitric oxide sensor for measuring nitric oxide concentrations as a concentration of one analyte; continuously measuring (S25B), using the nitric oxide sensor, respectively, nitric oxide concentrations after administration of urea;
Gobert teaches a 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 (S25B), 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 Jones, Rabinovitz, Kahn, Bulitta, 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 et al. (US 20060052667 A1) in view of Jones et al. (US 20200262908 A1), Rabinovitz et al. (US 20140316222 A1), Kahn et al. (US 20120187000 A1), Bulitta et al. (US 20110092787 A1), Hubbard et al. (US 20040077965 A1), Gobert et al. (“Helicobacter pylori arginase inhibits nitric oxide production by eukaryotic cells: A strategy for bacterial survival,” 2001, reference U on PTO-892), 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).
Regarding Claim 7, Palti in view of Jones, Rabinovitz, Kahn, Bulitta, Hubbard, and Gobert the method according to claim 6. Palti in view of Jones, Rabinovitz, Kahn, Bulitta, Hubbard, and Gobert are silent in teaching all of the claim limitations within claim 7.
Hubbard teaches wherein assessing (S5) gut health of the subject based on the measured analyte concentrations comprises: determining (S51B1) a degree of elevation of ammonium ion concentrations in the gastrointestinal tract by subtracting the baseline ammonium ion concentration from the measured ammonium ion concentrations after administration of urea (Hubbard | Table 2; Figure 4; Paragraphs 0073-0076);
correlating (S52) the degree of elevation of ammonium ion concentrations to the presence or 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 (S53B) gut health based on the presence or absence of Helicobacter pylori activity (Hubbard | Table 2; Paragraph 0076) 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.];
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, Bulitta, Hubbard, and Gobert 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).
Additionally, Palti in view of Jones, Rabinovitz, Kahn, Bulitta, Hubbard, and Gobert is silent in teaching determining (S51 B2) a degree of elevation of nitric oxide concentrations in the gastrointestinal tract by comparing the measured nitric oxide concentrations to a predetermined threshold; wherein a measured concentration of nitric oxide being above or equal to the predetermined threshold is considered as a significant degree of elevation;
Gobert teaches determining (S51 B2) a degree of elevation of nitric oxide concentrations in the gastrointestinal tract by comparing the measured nitric oxide concentrations 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.]); wherein a measured concentration of nitric oxide being above or equal to the predetermined threshold is considered as a significant degree of elevation (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 Palti in view of Jones, Rabinovitz, Kahn, Bulitta, Hubbard, and Gobert 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.).
Lastly, Palti in view of Jones, Rabinovitz, Kahn, Bulitta, Hubbard, and Gobert is silent in teaching correlating (S522) the degree of elevation of nitric oxide concentrations to the presence or absence of ulcers and/or inflammation; wherein (S531A) 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 (S532A) 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 (S533A) 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 (S534A) 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 (S522) 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 (S531A) 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 (S532A) 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 (S533A) 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 (S534A) 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 Jones, Rabinovitz, Kahn, Bulitta, 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 et al. (US 20060052667 A1) in view of Jones et al. (US 20200262908 A1), Rabinovitz et al. (US 20140316222 A1), Kahn et al. (US 20120187000 A1), and Tsutsumi at al. (US 20020197342 A1).
Regarding Claim 8, Palti in view of Jones, Rabinovitz, and Kahn teach the method according to anyone of claims 2, the smart pill (Palti | in vivo device – element 10); ammonium ion concentrations as the smart pill travels through the gastrointestinal tract, wherein said measuring includes measuring in stomach (S2201), measuring in small intestine (S2202) and measuring in large intestine (S2203) (Palti | Paragraph 0007).
Palti in view of Jones, Rabinovitz, and Kahn is silent in teaching continuously measuring (S210), using the pH sensor, hydrogen ion concentrations to determine, based on the hydrogen ion concentrations and a time that has passed from oral administration of the smart pill, a location of the smart pill in the gastrointestinal tract;
continuously measuring (S210), using the pH sensor, hydrogen ion concentrations to determine, based on the hydrogen ion concentrations and a time that has passed from oral administration of the smart pill, 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 Jones, Rabinovitz, and Kahn 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 Jones, Rabinovitz, and Kahn is silent in teaching the smart pill comprises a nitric oxide sensor for measuring nitric oxide concentrations or an ammonium sensor for measuring ammonium ion concentrations as a concentration of one analyte, wherein the measuring (S2) a concentration of the two analytes and transmitting (S3) the measured concentrations; continuously measuring (S220A), using the nitric oxide sensor or ammonium sensor; continuously transmitting (S31OA), using the communication interface, the measured concentrations from the two sensors to the base device;
Rabinovitz teaches the smart pill comprises a nitric oxide sensor for measuring nitric oxide concentrations or an ammonium sensor for measuring ammonium ion concentrations as a concentration of one analyte (Rabinovitz | Paragraph 0036 [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.]), wherein the measuring (S2) a concentration of the two analytes and transmitting (S3) the measured concentrations (Rabinovitz | Paragraph 0037);
continuously measuring (S220A), using the nitric oxide sensor or ammonium sensor (Rabinovitz | Paragraph 0036 [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.]);
continuously transmitting (S31OA), using the communication interface (Rabinovitz | display unit – element 18), the measured concentrations 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 Jones, Rabinovitz, and Kahn 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 Jones, Rabinovitz, and Kahn is silent in teaching 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 Jones, Rabinovitz, and Kahn 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 et al. (US 20060052667 A1) in view of Jones et al. (US 20200262908 A1), Rabinovitz et al. (US 20140316222 A1), Kahn et al. (US 20120187000 A1), Tsutsumi at al. (US 20020197342 A1), Gobert et al. (“Helicobacter pylori arginase inhibits nitric oxide production by eukaryotic cells: A strategy for bacterial survival,” 2001, reference U on PTO-892), 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).
Regarding Claim 9, Palti in view of Jones, Rabinovitz, Kahn and Tsutsumi the method according to claim 8, wherein the smart pill (Palti | in vivo device – element 10)
Palti in view of Jones, Rabinovitz, Kahn and Tsutsumi is silent in teaching comprises a nitric oxide sensor and wherein assessing (S5) gut health of the subject based on the measured analyte concentrations; determining (S510A1) a degree of elevation of nitric oxide concentrations in the gastrointestinal tract by comparing the measured nitric oxide concentrations to a predetermined threshold; correlating (S521 OA) the degree of elevation of nitric oxide concentrations to the presence or absence of ulcers and/or inflammation, wherein a measured concentration of nitric oxide being above or equal to the predetermined threshold is considered as a significant degree of elevation;
Gobert teaches comprises a nitric oxide sensor and wherein assessing (S5) gut health of the subject based on the measured analyte concentrations (Gober | Page 2, under section “Measurement of NO Concentration”);
determining (S510A1) a degree of elevation of nitric oxide concentrations in the gastrointestinal tract by comparing the measured nitric oxide concentrations 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 (S521 OA) the degree of elevation of nitric oxide concentrations to the presence or absence of ulcers and/or inflammation, wherein a measured concentration of nitric oxide being above or equal to the predetermined threshold is considered as a significant degree of elevation (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 Palti in view of Jones, Rabinovitz, Kahn 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.).
Palti in view of Jones, Rabinovitz, Kahn, Tsutsumi, and Gobert is silent in teaching assessing (S530A) gut health based on the presence or absence of ulcers and/or inflammation, wherein a significant degree of elevation nitric oxide concentrations are correlated with the presence of ulcers and/or inflammation, and wherein a non-significant degree of elevation of nitric oxide concentrations are correlated with the absence of ulcers and inflammation;
Sakaguchi teaches assessing (S530A) gut health based on the presence or absence of ulcers (Sakaguchi | Page 6 – first Paragraph under Discussion) and/or inflammation,
wherein a significant degree of elevation nitric oxide concentrations are correlated with the presence of ulcers (Sakaguchi | Page 6 – first Paragraph under Discussion) and/or inflammation, and
wherein a non-significant degree of elevation of nitric oxide concentrations are 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 Palti in view of Jones, Rabinovitz, Kahn, 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 et al. (US 20060052667 A1) in view of Jones et al. (US 20200262908 A1), Rabinovitz et al. (US 20140316222 A1), Kahn et al. (US 20120187000 A1), Tsutsumi at al. (US 20020197342 A1), Gobert et al. (“Helicobacter pylori arginase inhibits nitric oxide production by eukaryotic cells: A strategy for bacterial survival,” 2001, reference U on PTO-892), Sakaguchi et al. (“Increased Expression Of Inducible Nitric Oxide Synthase And Peroxynitrite In Helicobacter Pylori Gastric Ulcer,” 1999, reference V on the PTO-892) 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).
Regarding Claim 10, Palti in view of Palti in view of Jones, Rabinovitz, Kahn, Tsutsumi, Gobert, and Sakaguchi teach the method according to claim 9. Palti in view of Jones, Rabinovitz, Kahn, Tsutsumi, and Gobert, and Sakaguchi is silent in teaching 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;
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 Jones, Rabinovitz, Kahn, Tsutsumi, Gobert, 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).
Additionally, Palti in view of Jones, Rabinovitz, Kahn, Tsutsumi, Gobert, and Sakaguchi is silent in teaching wherein determining (S510A1) a degree of elevation of nitric oxide concentrations in the gastrointestinal tract;
Gobert teaches determining (S510A1) a degree of elevation of nitric oxide concentrations 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 Jones, Rabinovitz, Kahn, Tsutsumi, Gobert, 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.).
Lastly, Palti in view of Jones, Rabinovitz, Kahn, Tsutsumi, Gobert, and Sakaguchi is silent in teaching and wherein a significant degree of elevation of nitric oxide concentrations restricted to the large intestine is indicative of Ulcerative Colitis, a significant degree of elevation of nitric oxide concentrations throughout the gastrointestinal tract, not restricted to the large intestine, is indicative of Crohn's Disease;
Kimura teaches wherein a significant degree of elevation of nitric oxide concentrations restricted to the large intestine is indicative of Ulcerative Colitis, a significant degree of elevation of nitric oxide concentrations throughout the gastrointestinal tract, 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 Jones, Rabinovitz, Kahn, 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 et al. (US 20060052667 A1) in view of Jones et al. (US 20200262908 A1), Rabinovitz et al. (US 20140316222 A1), Kahn et al. (US 20120187000 A1), Tsutsumi at al. (US 20020197342 A1), Gobert et al. (“Helicobacter pylori arginase inhibits nitric oxide production by eukaryotic cells: A strategy for bacterial survival,” 2001, reference U on PTO-892), 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), and Hubbard et al. (US 20040077965 A1).
Regarding Claim 11, Palti in view of Jones, Rabinovitz, Kahn, Tsutsumi, Gobert, and Sakaguchi teaches the method according to claim 9, wherein the smart pill (Palti | in vivo device – element 10).
Palti in view of Jones, Rabinovitz, Kahn, Tsutsumi, Gobert, and Sakaguchi is silent in teaching correlating (S5210B) the degree of elevation of ammonium ion concentrations to a level of protein fermentation; and assessing (S530A) gut health based on the level of protein fermentation, wherein a significant degree of elevation of ammonium ion concentrations indicates a high level of protein fermentation, a non-significant degree of elevation of ammonium ion concentrations indicates a low level of protein fermentation, and/or a positive degree of elevation of ammonium ion concentrations compared to the reference value indicates an increased level of protein fermentation and a negative degree of elevation of ammonium ion concentrations compared to the reference value indicates a decreased level of protein fermentation;
Tsutsumi teaches correlating (S5210B) the degree of elevation of ammonium ion concentrations to a level of protein fermentation (Tsutsumi | Paragraph 0020); and
assessing (S530A) gut health based on the level of protein fermentation, wherein a significant degree of elevation of ammonium ion concentrations indicates a high level of protein fermentation (Tsutsumi | Paragraph 0020), a non-significant degree of elevation of ammonium ion concentrations 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 ammonium ion concentrations compared to the reference value indicates an increased level of protein fermentation and a negative degree of elevation of ammonium ion concentrations 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 Jones, Rabinovitz, Kahn, Tsutsumi, 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 Jones, Rabinovitz, Kahn, Tsutsumi, Gobert, and Sakaguchi are silent in teaching comprises an ammonium ion sensor and wherein assessing (S5) gut health of the subject based on the measured analyte concentrations comprises: determining (S510A2) a degree of elevation of ammonium ion concentrations in the gastrointestinal tract by comparing the measured ammonium ion concentrations to a reference value;
Hubbard teaches comprises an ammonium ion sensor and wherein assessing (S5) gut health of the subject based on the measured analyte concentrations; determining (S510A2) a degree of elevation of ammonium ion concentrations in the gastrointestinal tract by comparing the measured ammonium ion concentrations 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).
Claims 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Palti et al. (US 20060052667 A1) in view of Jones et al. (US 20200262908 A1), Rabinovitz et al. (US 20140316222 A1), Kahn et al. (US 20120187000 A1), and Bulitta et al. (US 20110092787 A1).
Regarding Claim 13, Palti discloses a smart pill (10) (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 (20) (power source- element 25),
a communication interface (transmitter – element 26; Paragraph 0016) (50) comprising a transceiver for enabling wireless communication between the smart pill (10) and a base device (70) and being configured to transmit and receive data between the sensors (30) and the base device (receiving unit – element 1000) (Paragraphs 0022-0024).
Palti is silent in teaching one or more sensors (30), being configured to measure concentrations of different analytes inside the gastrointestinal tract of the subject; electronic circuits (40) for enabling a connection between the sensors (30), the reference electrode (60) and the communication interface (50), and being configured to convey data from the sensors (30) to the communication interface (50);
Jones teaches the smart pill (Jones | ingestible device – element 100) comprising one or more sensors (30), being configured to measure concentrations of different analytes inside the gastrointestinal tract of the subject (Jones | 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; [Examiner’s note, one skilled in the art can determine the one or more chemical sensors are used to measure analytes.]),
electronic circuits (Jones | printed circuit board – element 120) (40) for enabling a connection between the sensors (30), the reference electrode (60) and the communication interface (50), and being configured to convey data from the sensors (30) to the communication interface (50) (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 Jones is silent in teaching at least one of the one or more sensors comprising a non-degradable membrane; a reference electrode (60). Rabinovitz teaches at least one of the one or more sensors (Rabinovitz | Paragraph 0046, In some embodiments, reference electrode 12 may be made of an inert material, e.g., gold. In some embodiments, working electrode 13, may be made of an inert material, e.g., gold, and substantially entirely coated with a salt dissolvable in the presence of ammonia, e.g., silver-chloride; [Examiner’s note, gold is a nondegradable membrane.]); a reference electrode (60) (Rabinovitz | reference electrode – element 12).
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 to incorporate the teachings of one or more sensors 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).
In the teachings of Rabinovitz regarding Palti in view of Jones and Rabinovitz, discusses the smart pill containing a reference and working electrode, but they are silent in teaching two or more sensors/electrodes that collect analyte concentrations;
Kahn teaches two or more sensors that collect different analyte concentrations (Kahn | Paragraph 0237-0238). 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 Kahn to incorporate the teachings of two or more working electrodes from Kahn because the working electrode, along with the reference electrode, measures target analyte concentrations (Kahn | Paragraph 0143).
Lastly, Palti in view of Jones, Rabinovitz, and Kahn is silent in teaching at least one of the sensors comprising a non-degradable membrane;
Bulitta teaches sensors comprising a non-degradable membrane (Bulitta | Paragraph 0026, 0040). 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 Kahn to incorporate the teachings of a non-degradable membrane. Doing so will prevent the erosion of the sensors from the patient's GI tract, which is typically an acidic environment. The semipermeable aspect of the membrane allows for the sensor to measure target analyte concentrations (Bulitta | Paragraphs 0026, 0040, 0044).
Regarding Claim 15, Palti in view of Jones, Rabinovitz, Kahn, and Bulitta teaches the smart pill (10) according to claims 13, configured to perform a method for measuring concentrations of analytes in a gastrointestinal tract of a subject, the method comprising:
orally administering (S1) a smart pill to the subject (Paragraph 0034), 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
wherein one of the sensors is a pH sensor (image sensor – element 24) for measuring hydrogen ion concentrations as a concentration of one analyte 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 (S3), using the communication interface (receiving unit – element 1000), the measured concentrations from the two or more sensors to a base device located outside of a body of the subject (Paragraphs 0022-0024).
Palti in view of Jones, Rabinovitz, Kahn, and Bulitta is silent in teaching the smart pill comprising two or more sensors; measuring (S2) a concentration of two or more analytes using the two or more sensors; electronic circuits, each sensor 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; wherein 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 teaches the smart pill (Jones | ingestible device – element 100) comprising one or more sensors (Jones | 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; [Examiner’s note, one skilled in the art can determine the one or more chemical sensors are used to measure analytes.]);
measuring (S2) a concentration of one or more analytes (Jones | Paragraph 0211) using the one or more sensors (Jones | 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; [Examiner’s note, one skilled in the art can determine the one or more chemical sensors are used to measure analytes.]);
electronic circuits (Jones | printed circuit board – element 120; Paragraph 0358), each sensor being able to measure a concentration of an analyte in the gastrointestinal tract of the subject (Jones | Paragraph 0365), wherein the one or more sensors measure different analytes (Jones | 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;);
wherein 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 Jones and Rabinovitz 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 Jones and Rabinovitz is silent in teaching a reference electrode; Rabinovitz teaches a reference electrode (Rabinovitz | reference electrode – element 12). 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 Rabinovitz 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).
In the teachings of Rabinovitz regarding Palti in view of Jones, Rabinovitz, Kahn, and Bulitta discusses the smart pill containing a reference and working electrode, but they are silent in teaching two or more sensors/electrodes that collect analyte concentrations;
Kahn teaches two or more sensors that collect different analyte concentrations (Kahn | Paragraph 0237-0238). 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 Rabinovitz to incorporate the teachings of two or more working electrodes from Kahn because measuring two different analyte concentrations simultaneously provides a comprehensive and accurate data collection for diagnosing a disease or disorder, and improves diagnostic accuracy within a complex environment, like the GI Track for determining whether a patient may or may not have H. pylori (Kahn | Paragraph 0143, 0234).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Palti et al. (US 20060052667 A1) in view of Jones et al. (US 20200262908 A1), Rabinovitz et al. (US 20140316222 A1), Kahn et al. (US 20120187000 A1), Bulitta et al. (US 20110092787 A1) and Betesh et al. (US 20070156016 A1).
Regarding Claim 14, Palti in view of Jones, Rabinovitz, Kahn, and Bulitta teaches the smart pill (10) according to claim 13. Palti in view of Jones and Rabinovitz is silent in teaching the smart pill further comprising one or more additional sensor, wherein said additional sensor is able to correct for interference of other compounds. Betesh teaches the smart pill further comprising one or more additional sensor, wherein said additional sensor is able to correct for interference of other compounds (Betesh | interference sensor – element 160; Paragraph 0003, Detection of interfering signals may be performed by an interference sensor that may be contained in the ingestible imaging device and/or in the external recorder). 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 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).
Conclusion
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/SRISTI DIVINA GOMES/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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