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 preliminary amendment filed 30 July 2024 has been entered. Claim(s) 1-3, 5, 8, 10-13, and 29-39 remain pending in the application.
Claim Objections
Claim 10 is objected to because of the following informalities:
Claim 10, line 2-3 “said beads” should be “said plurality of beads”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 5, 8, 10-13, and 29-39 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 “said opening” in line 4 of the claim. There is insufficient antecedent basis for this limitation of the claim. The “opening” is currently interpreted as referring to the “inlet” of line 2 of the claim.
Claim 29 recites the limitation “said voltage source” in line 3 of the claim. There is insufficient antecedent basis for this limitation of the claim. It is not clear if the claim should instead depend from claim 12, which introduces a voltage source but additionally provides antecedent basis for a switch and a fusible thread, or if the claim correctly depends from claim 1 but should be amended to include a voltage source in the list of elements in lines 1-2 of the claim.
Claim 32 recite the limitation “said measurement” in line 1 of the claim. There is insufficient antecedent basis for this limitation of the claim.
Claim 34 recite the limitation “said measurement” in line 1 of the claim. There is insufficient antecedent basis for this limitation of the claim.
Claim 39 recites the limitation “said capsule” in line 3 of the claim. There is insufficient antecedent basis for this limitation of the claim.
Claims 2-3, 5, 8, 10-13, and 29-38 are additionally rejected under 35 U.S.C. 112(b) as indefinite due to their dependence on claim 1 which has been rejected as indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2 and 39 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Thelu (US 20200297329 A1).
Regarding claim 1, Thelu teaches an apparatus for sampling liquid from a gastrointestinal tract (Paragraph 0011), said apparatus comprising an ingestible capsule (Casing 1) comprising an inlet (Opening 3), a valve (Flap 4; paragraph 0064), and a bead (Inner material 2) that closes said valve after having absorbed liquid that enters said opening (Paragraph 0101-0126--the intake of intestinal fluid into the device causes swelling of the inner material which induces the closure of the mechanism for closing the opening(s)… The more the volume of intestinal fluid taken into the device increases, the more the pressure applied by the inner material 2 onto the flap 4 increases, which strengthens the contact between the flap 4 and the casing 1, making it possible to block the opening 3 effectively.).
Regarding claim 2, Thelu teaches the apparatus of claim 1. Thelu additionally teaches wherein said valve blocks said inlet when said bead is swollen with liquid that has entered said opening (Paragraph 0101-0126--the intake of intestinal fluid into the device causes swelling of the inner material which induces the closure of the mechanism for closing the opening(s)… The more the volume of intestinal fluid taken into the device increases, the more the pressure applied by the inner material 2 onto the flap 4 increases, which strengthens the contact between the flap 4 and the casing 1, making it possible to block the opening 3 effectively).
Regarding claim 39, Thelu teaches a method comprising sampling liquid from a specified portion of a gastrointestinal tract (Paragraph 0011, 0101-0106—a method (P1) for collecting a sample of intestinal fluid), said method comprising causing said liquid to begin entering said capsule (Casing 1) when said capsule has arrived at said portion (Paragraph 0038, 0042, 0045, 0108-- the casing comprises 1, 2, 3, 4 or 5 openings, preferably a single opening. The opening allows the intake of intestinal fluid into the device, and therefore into the inner material… the gastro-resistant material is chosen according to the solubility thereof at the pH at the location where the intestinal fluid is to be collected) wherein liquid that enters said capsule causes a bead (Inner material 2) in said capsule to swell with said liquid, thereby closing a valve (Flap 4) in said capsule and preventing further entry of liquid (Paragraph 0101-0126--the intake of intestinal fluid into the device causes swelling of the inner material which induces the closure of the mechanism for closing the opening(s)… The more the volume of intestinal fluid taken into the device increases, the more the pressure applied by the inner material 2 onto the flap 4 increases, which strengthens the contact between the flap 4 and the casing 1, making it possible to block the opening 3 effectively.), said method further comprising recovering said capsule after said capsule has been ejected from said gastrointestinal tract (Paragraph 0106, 0128—retrieval of the device(s)).
Claim(s) 1-2, 10, and 39 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Duan (US 20200237350 A1).
Regarding claim 1, Duan teaches an apparatus for sampling liquid from a gastrointestinal tract (Paragraph 0030-0031—digestive tract multi-region liquid biopsy sampling device), said apparatus comprising an ingestible capsule comprising (Enclosure 10) an inlet (Holes 13), a valve (Piston ring 26), and a bead (Expandable materials 22) that closes said valve after having absorbed liquid that enters said opening (Paragraph 0040-0041-- after absorbing liquid, the expandable materials 22 expand to push the piston ring 26 to block the through holes 13; Figs. 5-9).
Regarding claim 2, Duan teaches the apparatus of claim 1. Duan additionally teaches wherein said valve blocks said inlet when said bead is swollen with liquid that has entered said opening (Paragraph 0040-0041-- after absorbing liquid, the expandable materials 22 expand to push the piston ring 26 to block the through holes 13; Fig. 5-9).
Regarding claim 10, Duan teaches the apparatus of claim 1. Duan additionally teaches wherein said bead is one of a plurality of beads that are between plates of said valve (See figs. 5-9, multiple beads of expandable material 22), wherein, during swelling thereof, said beads cooperate to urge said plates apart so as to close said valve (Paragraph 0040-0041; Figs. 5-9-- expansion of each bead of the expandable materials 22 causes the plates 26 at each end of the capsule to be urged apart to block the holes 13).
Regarding claim 39, Duan teaches a method comprising sampling liquid from a specified portion of a gastrointestinal tract (Paragraph 0006-0007), said method comprising causing said liquid to begin entering said capsule when said capsule has arrived at said portion (Paragraph 0033-- Different targeted dissolution membranes 21 that can dissolve at different targeted regions cover the through holes 13 of each sampling chamber 12; targeted dissolution membrane 21), wherein liquid that enters said capsule causes a bead in said capsule to swell with said liquid, thereby closing a valve in said capsule and preventing further entry of liquid (Paragraph 0040-0041-- the expandable materials 22 are disposed at a side of the piston ring 26 away from the through holes 13, and after absorbing liquid, the expandable materials 22 expand to push the piston ring 26 to block the through holes 13; Figs. 5-9), said method further comprising recovering said capsule after said capsule has been ejected from said gastrointestinal tract (Paragraph 0005-0007, 0032-0033-- digestive tract multi-region liquid biopsy sampling device can accurately sample liquid at a plurality of targeted regions. It is noted that as the disclosure describes the collection of liquid to be used in diagnosis of disease and describes the passage of the device through the body, the device must be retrieved in order to perform analysis of the collected liquid).
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duan in view of Jones (US 20200113521 A1).
Regarding claim 3, Duan teaches the apparatus of claim 1. Duan additionally teaches said valve comprises plates, wherein said bead, when swollen, urges said plates apart (Paragraphs 0040-0041; Fig. 5-9—expansion of the expandable materials 22 causes the plates 26 at each end of the capsule to be urged apart to block the holes 13).
However, Duan fails to disclose a spring that urges said plates together.
Jones, in the same field of endeavor of a gastrointestinal sampling device (Device 1), discloses a valve of the device may include two plates and a spring (Plates 126, spring 124), wherein the spring urges the plates together (Paragraph 0053-0055). While the particular arrangement of Jones functions to close the valve by urging the springs together, Jones generally makes clear that a spring may be utilized to bias plates of a valve to a particular condition which may be overcome by the presence of material which biases the plates in the opposite direction (see description of PVOH material 125 in paragraphs 0054-0055, which forces the plates apart).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Duan to include a spring between the plates as disclosed by Jones in order to ensure that the holes remain open until a maximum amount of fluid has been collected to predictably improve the amount of fluid which may be collected for further analysis.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duan in view of Sprenkels (WO 2007061305 A2).
Regarding claim 8, Duan teaches the apparatus of claim 1. However, Duan fails to disclose or suggest a microfluidic diode that extends from said inlet into an interior of said capsule, said microfluidic diode being oriented to promote flow into said capsule and inhibit flow out of said capsule.
Sprenkels, in the same field of endeavor of a swallowable GI sampling device, discloses the device includes a microfluidic diode that extends from said inlet into an interior of said capsule, said microfluidic diode being oriented to promote flow into said capsule and inhibit flow out of said capsule (Paragraph 0039, 0044-- the perimeter and length of the channel and the material of body 10 and cover 40 are selected such that capillary forces can be used for sampling liquids from the GI tract… One may desire to tune the flow of GI liquid into channel 30 (i.e. sampling speed)). It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Duan to include a microfluidic diode such as that taught by Sprenkels in order to predictably improve the device by controlling the flow of liquid into the sample chamber in order to ensure that liquid is sampled throughout the entire portion of interest of the GI tract rather than only one part.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duan in view of Houzego (US 20020055734 A1).
Regarding claim 12, Duan teaches the apparatus of claim 1. However, Duan is silent as to a fusible thread that is configured to urge said valve to remain closed and a switch that, when closed, connects a voltage source to said fusible thread, thereby destroying said fusible thread.
Houzego, in the same field of endeavor of an ingestible device (Abstract), discloses the device comprising a fusible thread (paragraph 0116--thread 19 made of or at least including a sharp melting point material; Fig. 4) that is configured to urge a cylindrical piston 16 to a distal position (Fig. 1; paragraph 0123) and a switch (paragraph 0124--PCB having a receiver which directs current to a heater upon passing through an electromagnetic field), that when closed connects a voltage source to said fusible thread, thereby destroying said fusible thread (paragraph 0124-- heat from the heater 20 melts or renders highly ductile the thread 19, whereby piston 16 becomes free to move towards bung 14 powered by the energy stored in the spring).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Duan to include a fusible thread configuration as described by Houzego, to predictably improve the device by temporarily holding the rings 26 in a sealed position prior to sampling, to prevent premature sampling during delivery of the capsule to the portion(s) of the GI tract which is of interest.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duan in view of Imran (US 20170258732).
Regarding claim 13, Duan teaches the apparatus of claim 1. Duan additionally teaches that when the valve is open, sampling of said liquid occurs (Paragraph 0040-0041). However, Duan is silent as to a magnet and a reed switch, wherein exposure of said reed switch to a magnetic field provided by said magnet causes said valve to open.
Imran, in the same field of endeavor of a swallowable device, teaches a device including a magnet and a reed switch wherein exposure of said reed switch to a magnetic field provided by said magnet causes said valve to open (paragraph 0102).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Duan to include a switch arrangement as disclosed by Imran, to predictably improve the device by temporarily holding the rings 26 in a sealed position prior to sampling, to prevent premature sampling during delivery of the capsule to the portion(s) of the GI tract which is of interest.
Claim(s) 29-31 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duan in view of Houzego, further in view of Shalon (US 20200138416 A1).
Regarding claim 29, Duan teaches the apparatus of claim 1. However, Duan is silent as to further comprising an electrochemical sensor, a controller, a switch, a wire, and a fusible thread, wherein said wire connects said fusible thread to said voltage source via said switch, wherein said electrochemical sensor is disposed on said capsule to monitor an environment of said capsule and to provide information representative of said environment, and wherein said controller controls said switch based at least in part on said information.
Houzego, in the same field of endeavor of an ingestible device (Abstract), discloses the device comprising a fusible thread (paragraph 0116--thread 19 made of or at least including a sharp melting point material; Fig. 4) that is configured to urge a cylindrical piston 16 to a distal position (Fig. 1; paragraph 0123) and a switch (paragraph 0124--PCB having a receiver which directs current to a heater upon passing through an electromagnetic field), that when closed connects a voltage source to said fusible thread, thereby destroying said fusible thread (paragraph 0124-- heat from the heater 20 melts or renders highly ductile the thread 19, whereby piston 16 becomes free to move towards bung 14 powered by the energy stored in the spring).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Duan to include a fusible thread configuration as described by Houzego, to predictably improve the device by temporarily holding the rings 26 in a sealed position prior to sampling, to prevent premature sampling during delivery of the capsule to the portion(s) of the GI tract which is of interest.
However, the combination fails to disclose electrochemical sensor, a controller, wherein said electrochemical sensor is disposed on said capsule to monitor an environment of said capsule and to provide information representative of said environment, and wherein said controller controls said switch based at least in part on said information.
Shalon, in the same field of endeavor of an ingestible device for collecting gastrointestinal samples, teaches a capsule having an electrochemical sensor (Paragraph 0162—pH sensor 78. s), a controller (Paragraph 0162—can be programmed in device 10), a switch (Paragraph 0304—moisture sensitive switch), an opening mechanism connected to a voltage source via said switch (Paragraph 0303-- an electrical or chemical power source that causes a phase change in a material that subsequently enables or triggers sample collection), wherein said electrochemical sensor is disposed on said capsule to monitor an environment of said capsule and to provide information representative of said environment, and wherein said controller controls said switch based at least in part on said information (Paragraph 0162— valve seal 38 is controlled by pH sensor 78. During transit of device 10 through the GI tract, when specific pH levels, or the rates of change of pH levels, are sensed by pH sensor 78 in a predicted and pre-programed sequence corresponding to ascending pH though the small intestine and then descending pH in the right colon, pH sensor 78 triggers the momentary opening of normally-closed valve seal 38 to enable collection of gastrointestinal samples; Paragraph 0304-0305-- a moisture sensitive switch is activated that starts a timing circuit that triggers sampling events at set time points to sample specific sampling regions of the small intestine and colon based on known transit times through these regions).
It would have been obvious to one having ordinary skill in the art the time of filing to modify the device of Duan and Houzego, including a fusible thread and switch for allowing the device to begin sampling at a desired time and location, to include the electrochemical sensor and controller of Shalon in order to predictably improve the device by allowing the timing of sampling to be controlled according to the environment of the capsule to limit sampling to the portion(s) of the GI tract which is of interest.
Regarding claim 30, the combination of Duan, Houzego, and Shalon teaches the apparatus of claim 29. Shalon additionally teaches wherein said electrochemical sensor is functionalized for measurement of acidity or alkalinity of said gastrointestinal tract (Paragraph 0162—pH sensor).
Regarding claim 31, the combination of Duan, Houzego, and Shalon teaches the apparatus of claim 29. Shalon additionally teaches that position of the GI tract sampled by the device may be determined by different parameters (Paragraph 0265-0277), where the parameter may include presence of bile (Paragraph 0277-- clear samples are associated with the stomach, yellow tinted samples are associated with the bile acids present in the proximal portion of the small intestine, light green tinted samples are associated with the distal small intestines, dark green or light brown tinted samples are associated with the proximal or ascending colon, and dark brown tinted samples are associated with the fecal matter present in the distal colon).
As a result, it would have been obvious to one having ordinary skill in the art at the time of filing to modify the apparatus of the combined Duan, Houzego, and Shalon, including an environmental sensor for determining a position of the device within the GI tract, to measure bile in said gastrointestinal tract as a means of predictably improving the specific delivery of the device to a desired portion of the GI tract before sampling is begun.
Regarding claim 37, the combination of Duan, Houzego, and Shalon teaches the apparatus of claim 29. Shalon additionally teaches that position of the GI tract sampled by the device may be determined by different parameters (Paragraph 0265-0277), where the parameter may include dissolved oxygen concentration (Table 4—examples of position identification parameters—dissolved or free gas content--oxygen).
As a result, it would have been obvious to one having ordinary skill in the art at the time of filing to modify the apparatus of the combined Duan, Houzego, and Shalon, including an environmental sensor for determining a position of the device within the GI tract, to measure dissolved oxygen concentration in said gastrointestinal tract as a means of predictably improving the specific delivery of the device to a desired portion of the GI tract before sampling is begun.
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duan in view of Houzego, further in view of Shalon, further in view of Sprenkels.
Regarding claim 36, the combination of Duan, Houzego, and Shalon teaches the apparatus of claim 29. Shalon additionally teaches that position of the GI tract sampled by the device may be determined by different parameters (Paragraph 0265-0277). However, Shalon does not disclose wherein the measured parameter may be amounts of short-chain fatty acids in said gastrointestinal tract.
Sprenkels, in the same field of endeavor of a swallowable GI sampling device, discloses that short-chain fatty acids may be associated with a particular position within the GI tract (Paragraph 0137-- the presence and concentration of butyrate is interesting, as this is the preferred fuel of colonocytes, the epithelial cells lining the large intestine).
As a result, it would have been obvious to one having ordinary skill in the art at the time of filing to modify the apparatus of the combined Duan, Houzego, and Shalon, including an environmental sensor for determining a position of the device within the GI tract, to measure short-chain fatty acids in said gastrointestinal tract as disclosed by Sprenkels as a means of predictably improving the specific delivery of the device to a desired portion of the GI tract before sampling is begun.
Allowable Subject Matter
Claims 5, 11, 32-35, 38 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 and rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 5, the most pertinent prior art of the record, Duan, discloses wherein said bead is a first bead and wherein said apparatus further comprises a second bead that absorbs said liquid (See figs. 5-9, multiple beads of expandable material 22). However, Duan fails to disclose wherein said second bead is outside said valve such that swelling of said second bead does not urge said valve to close. As the valve encompasses the entire capsule between the sets of holes (holes 13), Duan may be seen to teach away from a second bead which is outside said valve such that swelling of said second bead does not urge said valve to close. The second most pertinent prior art, Thelu, similarly fails to disclose wherein said bead is a first bead and wherein said apparatus further comprises a second bead that absorbs said liquid, wherein said second bead is outside said valve such that swelling of said second bead does not urge said valve to close. Even if Thelu were modified to include multiple beads, the positioning of the bead as described by Thelu would require that each bead contributes to urging the valve closed.
Regarding claim 11, the most pertinent prior art of the record, Duan, discloses a ballast disposed in said capsule (Balance weights 25, Figs. 5-9). However, Duan teaches away from the ballast being variable-weight and configured to increase in weight during sampling of said liquid (Paragraph 0039).
Regarding claims 32-35 and 38, the most pertinent prior art of the record, Shalon, discloses using an electrochemical sensor to measure various parameters which correspond to particular positions along the GI tract in order to determine when an ingestible capsule should begin sampling liquid. However, Shalon does not disclose or suggest measuring glucose, lactate, dopamine, serotonin, or neurotransmitters for this purpose.
Conclusion
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/ANNA ROBERTS/ Examiner, Art Unit 3791
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