DETAILED ACTION
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.
Claim(s) 1-2, 12, and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Felson (USP #3,485,235) in view of Lyutakov et al. (US 2023/0263510).
As to claim 1, Felson teaches an ingestible device (15) for sampling material in a gastrointestinal (GI) tract (col. 2 lines 13-15), the ingestible device comprising: a cap (16) and a module (17) configured to slide over the cap (Fig. 2-3), allowing for an expansion of the ingestible device (Fig. 3), wherein the module includes at least one chamber (30) having an inlet (26) and to be filled with a material to be sampled when the inlet of the at least one chamber overlaps with an opening (25) of the cap (Fig. 3); and an actuator (23) positioned at one end of the module covered by the cap (Fig. 1), wherein the actuator is configured, when activated, for sliding over the module so that the inlet of the at least one chamber overlaps with the opening of the cap to collect the material to be sampled (Fig. 3; col. 3 lines 1-11).
Felson fails to teach that the module is an electronics module. Lyutakov teaches a swallowable capsule for obtaining a fluid sample from the GI tract of a subject (Abstract) in which the device includes electronic components (11) to allow additional functionality, such as storing data or to allow better control of its various components ([0074]). It would have been obvious to modify Felson with Lyutakov to utilize an electronics module to allow for additional functionalities to the device for better control of the device.
As to claim 2, Felson fails to teach the actuator comprises: a gas generating cell positioned at one end of the electronics module that is covered by the cap, wherein the gas generating cell is configured to generate gas when the actuator is activated; and a small cap having one or more holes, coupled to the gas generating cell. Lyutakov teaches the use of a gas-generating cell (10) sitting within the electronics area (Fig. 2a), wherein the cell is configured to generate gas when the actuator is activated ([0074]) and a small cap having one or more holes (20), coupled to the gas generating cell (Fig. 4, middle portion of shell 2). It would have been obvious to modify the actuator of Felson with Lyutakov to allow for more precision in controlling when/where to open and close the sampling device, and improve the sample collection process.
As to claim 12, while the above combination does not teach the cap comprises one or more ridges configured to fit in a second set of grooves in the electronics module, and configured to prevent rotation of the cap over the electronics module and prevent the cap from sliding away from the electronics module, the examiner gives official notice that the use of ridges and grooves to paired components to prevent movement is well known in the art.
As to claim 15, Lyutakov teaches a body portion providing a hollow inner space sealed against environment of the body portion (17).
As to claim 16, Lyutakov teaches the hollow inner space of the body portion comprises a trigger unit (12) configured to activate the actuator ([0078]).
As to claim 17, Lyutakov teaches the hollow inner space of the body portion comprises a data recording unit for recording data during usage of the ingestible device ([0074]).
As to claim 18, while Lyutakov does not state verbatim that the data is environment data or localization data, as it can be used to store any kind of data, one such data would be the timing/location of when/where the sampling occurred, which would be a type of localization data.
As to claim 19, Lyutakov teaches a wireless data transmission unit for wirelessly transmitting environment data or localization data in real time during usage of the ingestible device ([0047]).
As to claim 20, Lyutakov teaches the ingestible device has a shape of a pill or a cylinder, or after the actuator is activated, a length of the ingestible device is lower than 31 millimeters, or a diameter of the ingestible device is lower than 9.9 millimeters (Fig. 1).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Felson (USP #3,485,235) in view of Lyutakov et al. (US 2023/0263510), and further in view of Srivastava et al. (US 2023/0181172).
The above combination fails to teach the chamber comprises a hydrophilic material having hydrogel configured to wick the material to be sampled. Srivastava teaches an oral capsule comprising a container (102) having on the inside a hydrogel (103) that is configured to absorb the intestinal content present in the vicinity of the container into the hydrogel ([0109]). As such, it would have been obvious to modify the above combination with Srivastava to use a hydrogel as a wicking material to enable faster and/or increase the amount of sampling.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Felson (USP #3,485,235) in view of Lyutakov et al. (US 2023/0263510) and Srivastava et al. (US 2023/0181172), and further in view of Shalon (US 2020/0138416).
As to claim 7, the above combination fails to teach hydrophilic material expands in volume when the material to be sampled is collected, and configured to release a preloaded substance from the at least one chamber. Shalon teaches a device for collecting gastrointestinal samples (Abstract) in which a hydrogel actuator expands when body fluids enter the device, pushing out preloaded thin disks (20) which allows for a succession of collecting members to be exposed to the GI tract for collecting fluids ([0117]). It would have been obvious to modify the above combination with Shalon to allow for collection of samples from multiple parts of the GI tract.
Claim(s) 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Felson (USP #3,485,235) in view of Lyutakov et al. (US 2023/0263510), and further in view of Shalon (US 2020/0138416).
As to claim 8, the above combination fails to teach at least three chambers, wherein the at least one chamber is one of the at least three chambers. Shalon teaches the use of multiple chambers (18) to allow for multiple samples to be collected. It would have been obvious to modify the above combination with Shalon to allow for collection of samples from multiple parts of the GI tract.
As to claim 9, Shalon teaches each chamber comprises an inlet (42) configured to align with the opening (18) of the cap to collect the material to be sampled when the cap slides over the electronics module (Fig. 4-5).
As to claims 10 and 11, the examiner gives official notice that O-rings are commonly used in the art to create a tight seal between different elements to prevent fluids from entering or escaping, and would have been obvious to incorporate into the structure to seal off individual components.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Felson (USP #3,485,235) in view of Lyutakov et al. (US 2023/0263510), and further in view of Srivastava et al. (US 2023/0181172) and Jones (US 2018/0052084).
As to claims 13 and 14, the above combination fails to teach a part of the inner inner space of the at least one chamber comprises a stabilizing substance for preserving the sampled material, said stabilizing substance being a quencher embedded in a hydrophilic material.
Srivastava teaches a hydrophilic material having hydrogel configured to wick the material to be sampled ([0109]). Jones teaches a GI sampling device in which preservatives (quenchers) can be used to stabilize the collected sample ([0425]). It would have been obvious to modify the above combination with Srivastava and Jones, so that the collected sample does not under go undesired changes between the time of sampling to the time of testing, so that the tested sample can be accurately reflective of the conditions at the time of sampling for greater accuracy.
Allowable Subject Matter
Claims 3-5 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As to claim 3, the prior art fails to teach and/or fairly suggest, in combination with all other recited limitations, that the generated gas flows through the holes of the small cap and fills a cavity formed between an end of the cap and the small cap. Instead Lyutakov’s holes function as a pressure-relieving outlet so that the pressure within the cavity does not build up over a certain amount.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/Primary Examiner, Art Unit 3791 7/23/26
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