DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed on January 20, 2026 was considered by the examiner. Claims 1-11, 13, 15-16, and 19 are pending in the application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is: a magnetic body in claim 8 and claim 20.
Prong 1: “body” is a generic placeholder. See MPEP 2181 §I, subsection A, ¶1.
Prong 2: the transition word “that” is used, followed by functional language:
“a magnetic body that… controlled by a magnetic field formed outside”.
Prong 3: there is not sufficient structure to modify the generic placeholder “body”.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
There is no corresponding structure in the specification for the magnetic body.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1, 8-9, and 13 are objected to because of the following informalities:
in claim 1, line 9: “a” should be inserted before “first”;
in claim 1, line 18: “sensor respectively” should be “sensor, respectively,”;
in claim 8, line 4: “is” should be inserted before “controlled”;
in claim 9, line 6: “is” should be inserted after “sensor”; and
in claim 13, line 4: “a” should be inserted before “second”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-11, 13, 15-16, and 19 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “a processor” in line 6. The specification only describes the usage of a control unit (see ¶[0041] and Fig. 1); however, the specification does not detail any processor, or that the control unit may comprise a processor. A control unit is not necessarily a processor, even if a processor could be considered a control unit. Therefore, the processor as recited in amended claim 1 is new matter that one of ordinary skill in the art would not have recognized Applicant was in possession of at the time the application was effectively filed.
Claims 2-11, 13, 15-16, and 19 are rejected by virtue of their dependence from claim 1.
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 1-11, 13, 15-16, and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “the sensor unit” in line 9. There is insufficient antecedent basis for this limitation in the claim. Amending this recitation to “the sensor” would overcome this rejection. The claim is being read as such for the purposes of examination.
Claim 1 recites “which are accommodated in the plurality of first accommodation spaces” in lines 19-20; however, it is not clear what is accommodated in the plurality of first accommodation spaces. The plurality of decomposition sections, the plurality of sensors, or a combination of both? It is not clear whether such each first accommodation space has the same arrangement as the others. These inconsistencies render claim 1 indefinite. Appropriate clarification is required.
Claim 1 recites “the processor is configured to remove any one of the plurality of cover sections by controlling the heating wire in a state in which the capsule is moved to any one position in a body, and then remove another one of the plurality of cover sections by controlling the heating wire in a state in which the capsule is moved to another position” in lines 26-29. This recitation appears to suggest that a single heating wire is utilized to remove any one of the wax covers. However, the recitation “each of the plurality of cover sections is formed of a wax material and includes a heating wire” in lines 24-25 indicates that each of the cover sections “is formed of a wax material and includes a heating wire”. This inconsistency renders claim 1 indefinite. Appropriate clarification is required.
Claims 2-11, 13, 15-16, and 19 are rejected by virtue of their dependence from claim 1.
Claims 2-11, 13, 15-16, and 19 recite “helicobacter pylori” in their respective preambles in line 1, and claim 6 additional recites “helicobacter pylori” in line 4. However, it is not clear if these recitations are the same as, related to, or different from the recitation of “helicobacter pylori” in claim 1, line 1. The similar phraseology suggests that they are the same, but the lack of the definite article “the” suggests that they are different. The recitations in claim 1, lines 3 and 7 including “the” further supports that these recitations are the same. If the recitations are the same, the present recitation should be “the helicobacter pylori”. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, these recitations are being interpreted as the same.
Claim 2 recites the limitation “the control unit” in line 4. There is insufficient antecedent basis for this limitation in the claim. Amending this recitation to “the processor” would overcome this rejection. The claim is being read as such for the purposes of examination.
Claim 3 recites the limitation “the control unit” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Amending this recitation to “the processor” would overcome this rejection. The claim is being read as such for the purposes of examination.
Claim 5 recites “the decomposition section” in line 3; however, it is not clear to which of, or to all of, the plurality of decomposition sections (see claim 1, lines 18-19) the singular recitation of claim 5 is referring to. Appropriate clarification is required.
Claim 6 recites “the decomposition section” in line 3; however, it is not clear to which of, or to all of, the plurality of decomposition sections (see claim 1, lines 18-19) the singular recitation of claim 6 is referring to. Appropriate clarification is required.
Claim 7 recites “the is configured to transmit the measured pH value to the first outside” in lines 6-7; however, it is not clear what is configured to transmit. Amending the claim to recite “the processor is configured to transmit the measured pH value to the first outside” would overcome the present rejection. The claim is being read as such for the purposes of examination.
Claim 8 limitation “magnetic body” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. There is no corresponding structure in the specification for the magnetic body. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 9 recites “the decomposition section” in lines 4, 5 and 6-7; however, it is not clear to which of, or to all of, the plurality of decomposition sections (see claim 1, lines 18-19) the singular recitations of claim 9 are referring to. Appropriate clarification is required.
Claim 11 recites “the decomposition section” in line 3; however, it is not clear to which of, or to all of, the plurality of decomposition sections (see claim 1, lines 18-19) the singular recitation of claim 11 is referring to. Appropriate clarification is required.
Claim 13 recites “second outside of the body section” in line 4. However, it is not clear whether the second outside is “of the body section” or whether it is an area outside of the body section. It appears as if the second outside is an area outside of the body section. Deleting “of the body section” would overcome the present rejection. The claim is being read as such for the purposes of examination.
Claim 15 recites “the decomposition section” in lines 3 and 5-6; however, it is not clear to which of, or to all of, the plurality of decomposition sections (see claim 1, lines 18-19) the singular recitations of claim 15 are referring to. Appropriate clarification is required.
Claim 15 recites “an inlet of the body section” in line 6, but it is not clear if this recitation is the same as, related to, or different from the recitation “a plurality of inlets” in claim 1, line 14. The similar phraseology suggests that they are the same, but the indefinite article “a” and “plurality” suggest that they are different. If the recitations are the same/related, the sealing lid section relationship to each of the inlets should be properly conveyed. If the recitations are different, the relationship between these recitations should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). For the purposes of examination, the recitations are being interpreted as the same/related.
Claim 16 is rejected by virtue of its dependence from claim 15.
Claim 16 recites “the decomposition section” in lines 3 and 5-6; however, it is not clear to which of, or to all of, the plurality of decomposition sections (see claim 1, lines 18-19) the singular recitations of claim 16 are referring to. Appropriate clarification is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 7-11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Rabinovitz et al. (US Patent Application Publication 2014/0296666 – cited in prior action), hereinafter Rabinovitz, and in view of Palti et al. (US Patent Application Publication 2006/0052667 – cited by Applicant), hereinafter Palti, and in view of Iddan et al. (US Patent Application Publication 2008/0208077 – cited in prior action), hereinafter Iddan, and in view of Jones et al. (US Patent Application Publication 2018/0168490), hereinafter Jones.
Regarding Claim 1, Rabinovitz teaches in-vivo devices, systems, and methods for the detection of blood within in-vivo bodily fluids within the GI-tract via light source/detector modality (see abstract and Fig. 9), in which the device may also be used for detecting H. pylori (see ¶[0129]), and the various aspects of the various embodiments are combinable with one another (see ¶[0359]). Rabinovitz teaches a capsule (see abstract and Fig. 9) for diagnosis of helicobacter pylori (see ¶[0129]), comprising:
a body section (¶[0157] the housing 501; Fig. 9) configured to introduce a gastrointestinal fluid including the helicobacter pylori (¶[0157]-[0159] the gap 502 for allowing GI fluid to flow therewithin; Fig. 9);
a decomposition section that is accommodated in the body section (¶[0157]-[0159] the gap 502 for allowing fluid to flow therewithin; Fig. 9);
a sensor configured to measure information on a result of the GI fluid in the decomposition section (¶[0157] the illumination sources 503 and the detector 504; Fig. 9); and
a processor configured to transmit the information measured by the sensor unit to first outside (¶[0160]-[0161] the processor 514 for processing the data and the transmitter 515 for transmitting the data to the external receiver);
a second accommodation space, the processor is accommodated in the second accommodation space (see Fig. 9, the portion of the housing 510 with the processor 514 and the transmitter 515), receives information from each of the sensors and transmits the information to the first outside (¶[0160]-[0161] the processor 514 for processing the data and the transmitter 515 for transmitting the data to the external receiver).
Rabinovitz is silent that the decomposition section contains urea.
Palti teaches a method and system for in vivo detection of H. pylori (see abstract), in which an in vivo device (capsule) 10 that may utilize an imaging system including the illumination unit 23 and the image sensor 24 for detecting pH, such as via color changing pH sensitive material, based off of the reaction of urea with bacteria urease (from the H. pylori bacteria) to indicate H. pylori presence which is then transmitted from the device (see ¶[0014]-[0016] and ¶[0027]-[0029]; Figs. 1A and 2), in which image data is transmitted from the device (see ¶[0022] and Fig. 1B).
Accordingly, it would have been obvious to implement the pH based H. pylori sensing modality of Palti with the illumination sources 503 and the detector 504 for the H. pylori sensing of Rabinovitz because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) Rabinovitz teaches detecting H. pylori but not specifically the modality and Palti teaches one such modality of H. pylori detection.
Here, urea is present in the GI fluid, so urea would therefore enter the decomposition section as being present within the GI fluid. As the claim only requires that urea be within the decomposition section, the modified Rabinovitz teaches that element of claim 1.
The modified Rabinovitz is silent regarding a plurality of first accommodation spaces including decomposition sections and sensor units therewithin.
Iddan teaches a device, system, and method for in-vivo sampling including sampling chamber (see abstract), in which the sensor may comprise an illumination source 20 and detector 22 about sampling chamber 12 (see ¶[0062] and Fig. 2), in which there may be multiple sampling chambers 12 gated for certain times (see ¶[0059] and ¶[0061]; see also ¶[0068]-[0071], the gate may include a dissolvable material, such as wax; Fig. 1), multiple illumination sources (see ¶[0107]), and multiple cameras as the detectors (see ¶[0063]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the gap and sensors in the modified Rabinovitz as shown by the multi-chamber sampling modality of Iddan because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the multi-chamber/gap modality would allow different samples to be drawn into the testing chambers at specified times or locations to enable more precise knowledge of the location from which a sample was taken (see Iddan ¶[0059]); and/or (3) this would be a mere duplication of parts that has no patentable significance because there is no new and unexpected result (see MPEP 2144.04(VI)(B)). In this case, the sampling at different locations in the body as taught in the present application is taught by Iddan, so it is not a new or unexpected result.
The modified Rabinovitz further teaches the body section has an upper portion in which a plurality of inlets respectively communicating with the plurality of first accommodation spaces are formed and has partition walls that are formed in the body portion and respectively separate the plurality of first accommodation spaces (see Iddan Fig. 1, the plurality inputs to the chambers 12; see Rabinovitz Fig. 9, a duplication of the gap and sensor portion);
a plurality of cover sections that are respectively installed at the plurality of inlets of the body section and removed as the cover sections come into contact with the gastrointestinal fluid (see Iddan ¶[0059] the gates that allow samples to be drawn into the testing chambers at specified times or locations to enable more precise knowledge of the location from which a sample was taken; Fig. 1); and
wherein the processor is configured to remove any one of the plurality of cover sections in a state in which the capsule is moved to any one position in a body, and then remove another one of the plurality of cover sections in a state in which the capsule is moved to another position (see Iddan ¶[0059] the gates that allow samples to be drawn into the testing chambers at specified times or locations to enable more precise knowledge of the location from which a sample was taken, indicating multiple locations; Fig. 1).
The modified Rabinovitz does not specifically teach that the plurality of cover sections include a heating wire for the dissolvable (i.e., the wax) material.
Jones teaches an ingestible device for producing spectral data of one or more analytes, and methods for characterizing the gastrointestinal tract of a subject (see abstract and Fig. 1), in which the device may comprise a sampling chamber that may be sealed by a single use sealing device, unsealed with a heating element (see ¶[0059]-[0060]), in which the single use sealing device 306 may comprise a wax plug and the heating element 308 may comprise a resistive heater (i.e., a wire) that undergoes ohmic heating as an electrical current is passed through (see ¶[1492]; Fig. 66).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the wax and resistive heater of Jones as the gates in the modified Rabinovitz because (1) it is the simple substitution of one known element for another to yield predictable results and/or (2) the modified Rabinovitz requires a gated structure to melt/dissolve so as to allow in GI fluid and Jones teaches one such melting modality.
Regarding Claim 2, Rabinovitz in view of Palti, Iddan, and Jones teaches the device of claim 1 as stated above. Rabinovitz further teaches a power supply that is accommodated in the body section and supplies power to the control unit (¶[0160] the internal power source 505; Fig. 9).
Regarding Claim 3, Rabinovitz in view of Palti, Iddan, and Jones teaches the device of claim 1 as stated above. Rabinovitz further teaches a power supply that is installed outside the body section and drives the control unit through a radio frequency identification (RFID) technique (¶[0160] the internal power source 505, ¶[0274] the power source may alternatively be a wireless power receiving unit based on RF power transmission; Fig. 9).
Regarding Claim 4, Rabinovitz in view of Palti, Iddan, and Jones teaches the device of claim 1 as stated above. Rabinovitz further teaches the upper portion of the body section is formed in a partially open shape (see Fig. 9, the portion of the housing 501 with the gap 502), and
the sensor and the processor are arranged in order below the decomposition section (see Fig. 9, the inner space of the housing 501 with the illumination sources 503 and the detector 504, with the processor 514 and the transmitter 515 below).
Regarding Claim 5, Rabinovitz in view of Palti, Iddan, and Jones teaches the device of claim 1 as stated above. Rabinovitz further teaches the decomposition section is arranged to be separated from the plurality of inlets of the body section (¶[0190]-[0192] the cover 1605 with filter and/or holes 1604 separated from the gap 1602 with the illumination sources 1613 and the light detector 1614; Figs. 16A-16C).
Regarding Claim 7, Rabinovitz in view of Palti, Iddan, and Jones teaches the device of claim 1 as stated above. The modified Rabinovitz further teaches the sensor is configured to measure a pH value of the gastrointestinal fluid that is changed by ammonia generated as the urea is decomposed (see Palti ¶[0014]-[0016] and ¶[0027]-[0029], the in vivo device (capsule) 10 that may utilize the imaging system including the illumination unit 23 and the image sensor 24 for detecting pH, such as via color changing pH sensitive material, based off of the reaction of urea with bacteria urease (from the H. pylori bacteria) to indicate H. pylori presence which is then transmitted from the device; Figs. 1A and 2), and
the processor is configured to transmit the measured pH value to the first outside (see Rabinovitz ¶[0160]-[0161], the processor 514 for processing the data and the transmitter 515 for transmitting the data to the external receiver).
Regarding Claim 8, Rabinovitz in view of Palti, Iddan, and Jones teaches the device of claim 1 as stated above. Rabinovitz further teaches a magnetic body that is accommodated in the body section and controlled by a magnetic field formed outside (¶[0038] the permanent magnet assembly that interacts with an external magnetic field so as to steer the device).
Regarding Claim 9, Rabinovitz in view of Palti, Iddan, and Jones teaches the device of claim 1 as stated above. The modified Rabinovitz further teaches a light source that is accommodated in the inner space of the body section and illuminates the decomposition section (see Rabinovitz ¶[0157], the illumination sources 503; Fig. 9),
wherein the decomposition section further includes an acid-base indicator, and the sensor configured to measure image information of the decomposition section illuminated by the light source unit (see Palti ¶[0014]-[0016] and ¶[0027]-[0029], the in vivo device (capsule) 10 that may utilize the imaging system including the illumination unit 23 and the image sensor 24 for detecting pH, such as via color changing pH sensitive material (the acid-base indicator), based off of the reaction of urea with bacteria urease (from the H. pylori bacteria) to indicate H. pylori presence which is then transmitted from the device; Figs. 1A and 2).
Regarding Claim 10, Rabinovitz in view of Palti, Iddan, and Jones teaches the device of claim 9 as stated above. The modified Rabinovitz further teaches the light source is installed on an inner wall of the body section (see Rabinovitz Fig. 9 and/or Fig. 16B, the illumination sources 503/1613 and the light detector 504/1614 are installed on inside walls of the capsule), and
the processor is further configured to transmit the image information formed by the sensor to the first outside as the light source unit illuminates the decomposition section (see Palti ¶[0014]-[0016] and ¶[0027]-[0029], the in vivo device (capsule) 10 that may utilize the imaging system including the illumination unit 23 and the image sensor 24 for detecting pH, such as via color changing pH sensitive material (the acid-base indicator), based off of the reaction of urea with bacteria urease (from the H. pylori bacteria) to indicate H. pylori presence which is then transmitted from the device, Figs. 1A and 2; see Rabinovitz ¶[0160]-[0161], the processor 514 for processing the data and the transmitter 515 for transmitting the data to the external receiver).
Regarding Claim 11, Rabinovitz in view of Palti, Iddan, and Jones teaches the device of claim 9 as stated above. The modified Rabinovitz further teaches the image information is one of an actual image of the decomposition section and an RGB value of the decomposition section (see Palti ¶[0022] image data is transmitted from the device; Fig. 1B).
Regarding Claim 13, Rabinovitz in view of Palti, Iddan, and Jones teaches the device of claim 12 as stated above. Rabinovitz further teaches that each of the plurality of cover sections seals a corresponding inlet of the plurality of inlets from second outside of the body section (see Figs. 14A-14B, the cover 1015 the body of device 1000 from the GI tract, the second outside).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Rabinovitz in view of Palti, Iddan, and Jones as applied to claim 1 above, and in view of Singh et al. (US Patent Application Publication 2018/0164221 – cited in prior action), hereinafter Singh.
Regarding Claim 6, Rabinovitz in view of Palti, Iddan, and Jones teaches the device of claim 1 as stated above. The modified Rabinovitz is silent regarding that the decomposition section further includes a buffer and a bacteriostatic agent that inhibits growth and proliferation of helicobacter pylori.
Singh teaches GI tract detection methods, devices, and systems (see abstract), including taking in a biological sample, such as H. pylori (see ¶[0106]-[0107]), and may utilize a preservative including a buffer (see ¶[1099] Trehalose in solution acts as a buffer) and a bacteriostatic agent (see ¶[1108]-[1110]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the buffer and the bacteriostatic agent of Singh with the modified Rabinovitz because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the Trehalose buffer would help stabilize proteins (i.e., the bacteria urease) (see Singh ¶[1099]); and/or (3) the bacteriostatic agent would arrest the bacterial (H. pylori) growth and multiplication, such that the bacteria in the device is representative of the bacterial microflora that was present in the GI tract at the time the bacteria first entered the device (see Singh ¶[1109]).
Claims 15-16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Rabinovitz in view of Palti, Iddan, and Jones as applied to claim 1 above, and in view of Heseltine et al. (WIPO Publication 2021/219891 – cited in prior action), hereinafter Heseltine.
Regarding Claim 15, Rabinovitz in view of Palti, Iddan, and Jones teaches the device of claim 1 as stated above. Rabinovitz teaches the usage of piston 512 and piston bellows 513 to block and unblock the gap 502 (see ¶[0158]-[0159]; Fig. 9), but the modified Rabinovitz does not specifically teach wherein the decomposition section further includes a swelling gel material that swells as the gastrointestinal fluid is absorbed, and the capsule further includes a sealing lid section that is placed on the decomposition section and seals an inlet of the body section as the decomposition section expands.
Heseltine teaches a modular ingestible capsule to gather molecules or fluids at select locations within the body (see abstract and Fig. 1), in which an expandable material 112, such as a hydrogel, positioned within the capsule, may expand when exposed to fluids, pushing cap 114 about the inlet port 110 so as to seal the capsule (¶[0066], ¶[0058]-[0059], and ¶[0075]; Figs. 2-5E).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the expandable material (hydrogel) and sealing cap of Heseltine as the movement and seal in the modified Rabinovitz because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) this would allow a sample to be collected, as this would seal the sample compartment, ensuring a “clean” sample can be retrieved after the capsule exits the body (see Heseltine ¶[0049]). Here, the cap (sealing lid) would necessarily be placed on top of the gap decomposition/sensor portion, as otherwise, the capsule (including sensors and electronics) would not be sealed.
Regarding Claim 16, Rabinovitz in view of Palti, Iddan, Jones, and Heseltine teaches the device of claim 15 as stated above. The modified Rabinovitz further teaches the decomposition section is separated from a lower side of the plurality of inlets and is formed in the inner space of the body section (see Rabinovitz ¶[0190]-[0192] the cover 1605 with filter and/or holes 1604 separated from the gap 1602 with the illumination sources 1613 and the light detector 1614; Figs. 16A-16C), and
the sealing lid section is placed on an upper portion of the decomposition section (see Heseltine ¶[0066], ¶[0058]-[0059], and ¶[0075], the expandable material 112, such as a hydrogel, positioned within the capsule, may expand when exposed to fluids, pushing cap 114 about the inlet port 110 so as to seal the capsule; Figs. 2-5E). Here, the cap (sealing lid) would necessarily be placed on top of the gap decomposition/sensor portion, as otherwise, the capsule (including sensors and electronics) would not be sealed.
Regarding Claim 19, Rabinovitz in view of Palti, Iddan, and Jones teaches the device of claim 1 as stated above. Rabinovitz teaches the usage of piston 512 and piston bellows 513 to block and unblock the gap 502 (see ¶[0158]-[0159]; Fig. 9), but the modified Rabinovitz does not specifically teach wherein each of the plurality of decomposition sections further includes a gel material that swells as the gel material comes into contact with a gastrointestinal fluid, and the capsule further includes a plurality of sealing lid sections that are respectively accommodated in the plurality of first accommodation spaces, placed on the plurality of decomposition sections, and respectively seal the plurality of inlets of the body section as the plurality of decomposition sections each expand.
Heseltine teaches a modular ingestible capsule to gather molecules or fluids at select locations within the body (see abstract and Fig. 1), in which an expandable material 112, such as a hydrogel, positioned within the capsule, may expand when exposed to fluids, pushing cap 114 about the inlet port 110 so as to seal the capsule (¶[0066], ¶[0058]-[0059], and ¶[0075]; Figs. 2-5E).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the expandable material (hydrogel) and sealing cap of Heseltine as the movement and seal in each of the gap sensor portions in the modified Rabinovitz because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) this would allow a sample to be collected, as this would seal the sample compartment, ensuring a “clean” sample can be retrieved after the capsule exits the body (see Heseltine ¶[0049]). Here, the cap (sealing lid) would necessarily be placed on top of the gap decomposition/sensor portion, as otherwise, the capsule (including sensors and electronics) would not be sealed.
Response to Arguments
Applicant’s amendments, 35 U.S.C. § 112(f) interpretation
In light of Applicant’s amendments filed January 20, 2026, with respect to the interpretation of the claim limitations a sensor unit, a control unit, a power supply unit, and a light source under 35 U.S.C. § 112(f) have been fully considered, and the claim interpretations under 35 U.S.C. § 112(f) have been withdrawn.
Applicant’s arguments, 35 U.S.C. § 101
Applicant’s arguments, see pg. 7, filed January 20, 2026, with respect to the rejections of claims 1-20 under 35 U.S.C. § 101 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn.
Applicant’s arguments, 35 U.S.C. § 112
Applicant’s arguments, see pg. 7, filed January 20, 2026, with respect to the rejections of claims 1-20 under 35 U.S.C. § 112 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection are made under 35 U.S.C. § 112 that were necessitated by Applicant’s amendment filed on January 20, 2026.
Applicant’s arguments, 35 U.S.C. § 103
Applicant’s arguments, see pg. 7, filed January 20, 2026, with respect to the rejections of claims 1-20 under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Jones et al. (US Patent Application Publication 2018/0168490).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.D.M./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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