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 .
Amendment Entered
In response to the amendment filed on February 25th, 2026, amended claims 1, 12, 17-19 are entered.
Response to Arguments
Applicant's remarks and amendments with respect to the claim objections have been fully considered. The objections are withdrawn in view of the amendment.
Applicant's remarks and amendments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections are withdrawn in view of the amendment.
Applicant’s arguments, filed on February 25th, 2026, with respect to the rejections under 35 U.S.C. 102 and 103 have been considered but are not fully persuasive. Although the previous rejections have been withdrawn in view of the amendment, Examiner respectfully disagrees that Sonkusale et al, Wrigglesworth et al, Singh et al, Shalon, and Jones fail to teach the limitations of Claim 1. The rejections have been further clarified and updated below.
At Pgs. 9-10 of the Reply, Applicant argues that D2 fails to teach all the limitations of Claim 3. Examiner agrees and has withdrawn the rejection. However, upon reconsideration, a new rejection has been made.
At Pg. 11 of the Reply, Applicant argues that “[c]laim 6 requires a ‘first piece’ that ‘forms a first plug that blocks said channel’ and also a ‘second piece’ that is ‘located so as to be transformable into a second plug that blocks’ that same channel”. The Examiner notes wherein the limitation “so as to be transformable into a second plug that blocks said channel” is a recitation of the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, the claimed element is transformable, as it is “capable of being transformed” (the definition of “transformable”).
At Pgs. 11-12 of the Reply, Applicant argues wherein D6 fails to teach the limitation “transition into a closed state that permits current…to flow through”. The Examiner notes wherein the limitation “that permits current driven by said voltage source to flow through said resistances” is a recitation of the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Furthermore, the Applicant argues that “[t]he examiner is perhaps broadly interpreting ‘voltage source’ as being any source of voltage. However, this is unreasonably broad”. Examiner respectfully disagrees. Currently, dependent claim 10 recites: “The apparatus of claim 1, further wherein said gut sampler further comprises a voltage source, switches, and resistances, wherein said switches transition into a closed state that permits current driven by said voltage source to flow through said resistances”. There are no specific requirements or limitations regarding the “voltage source”; therefore, the Examiner suggests that the Applicant amend the claims to add more specificities regarding the “voltage source” if a more specific interpretation is desired.
Further, at Pgs. 12-13 of the Reply, Applicant argues that “[a]n ordinary artisan would have expected a ‘panel’ to be a flat structure”. Examiner would like to clarify that the definition of a “panel” is “a flat or curved component”. Therefore, there is no clear requirement that a “panel” must be flat. Examiner suggests that the Applicant amend the claims to add the requirement of a “flat” panel if a more specific interpretation is desired.
With respect to newly added or amended claims, applicant should show support in the original disclosure for the new or amended claims. See, e.g., Hyatt v. Dudas, 492 F.3d 1365, 1370, n.4 (Fed. Cir. 2007) (citing MPEP § 2163.04 which provides that a "simple statement such as ‘applicant has not pointed out where the new (or amended) claim is supported, nor does there appear to be a written description of the claim limitation ‘_’ in the application as filed’ may be sufficient where the claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not pointed out where the limitation is supported."); see also MPEP §§ 714.02 and 2163.06 ("Applicant should ... specifically point out the support for any amendments made to the disclosure.").... MPEP 2163 II. A.
Lastly, Examiner notes that the Applicant’s reply does not show support for the claim amendments. Although amendments have been made to multiple claims, the Applicant has not pointed out where the amended claims are supported within the Applicant’s Specification. Examiner requests that in future amendments, for the Applicant to please specify where support can be found for the newly added claim limitations.
Claim Objections
Claims 12 and 19 are objected to because of the following informalities:
Claim 12 recites “an osmotic” in line 3, but should read “an osmotic”
Claim 19 recites “wherein said first piece forms a first plug that blocks said channel until said first plug piece is melted and wherein, after lapse of an interval, said second piece is melted so as to form a second plug that blocks said channel, whereby during said interval, sampling takes place” in lines 6-9, but should read “wherein said first piece forms a first plug that blocks said channel until said first plug piece is melted and wherein, during an interval of time, sampling takes place, and after lapse of said interval of time, said second piece is melted so as to form a second plug that blocks said channel”
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.
Claim 18 is 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 18 recites “wherein said panel is a flat panel”. However, the specification does not disclose a “flat” panel. It appears that Applicant relies on the drawings for support. In Hockerson-Halberstadt Inc. v. Avia Grp Int'l Inc., 55 USPQ2d 1487 (Fed. Cir. 2000), the patentee argued that "the specification contains figures depicting a groove that is wider than the fins." Id at 1491. The Court noted that the disclosure "is devoid of any indication that the proportions of the groove and fins are drawn to scale" and held "it is well established that patent drawings do not define the precise proportions of the elements and may not be relied on to show particular sizes if the specification is completely silent on the issue." Id. There is nothing in the specification of the instant application that indicates the drawings are drawn to scale. The specification does not state the shape of the panel. The drawings therefore cannot be relied on to support the claimed shape of the panel.
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 1-20 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 “a valve actuator” in line 8. However, the Examiner notes that there is no valve recited in independent claim 1. Therefore, it is unclear as to how the valve actuator can actuate something that does not exist, as it has not been claimed.
Claim 3 recites “a valve” in line 2. It is unclear as to whether this limitation is what the “valve actuator” of Claim 1 is supposed to be actuating, or if this is referring to a separate element.
Claim 6 recites “first and second pieces of a material and a channel” in lines 1-2. It is unclear as to what exactly this limitation entails, as the limitation could be interpreted in multiple ways, such as “first and second pieces of a material” and a separate “channel” or “first and second pieces”, wherein each of the pieces comprises both “a material and a channel”. Clarification is requested.
Claim 7 recites “a valve” in line 1. It is unclear as to whether this limitation is what the “valve actuator” of Claim 1 is supposed to be actuating, or if this is referring to a separate element.
Claim 9 recites “a valve” in lines 1-2. It is unclear as to whether this limitation is what the “valve actuator” of Claim 1 is supposed to be actuating, or if this is referring to a separate element.
Claim 9 recites “a controller configured to control actuation of said valve” in line 2. It is unclear as to whether this limitation is referring to the “valve actuator” of Claim 1, or if this is referring to a separate element. If this limitation is referring to a separate element, clarification is requested regarding how the “controller” and how the “valve actuator” differ from each other.
Claim 17 recites “wherein said transition between said first and second states of said shape-memory material causes said panel to transition between being in a raised state and being in a lowered state, thereby causing said inlet to transition between being closed and being opened” in lines 4-7. It is unclear as to whether the “first state” of the shape-memory material would cause the panel to be in a “raised state” and the “second state” of the shape-memory material would cause the panel to be in a “lowered state”, or the “first state” of the shape-memory material would cause the panel to be in a “lowered state” and the “second state” of the shape-memory material would cause the panel to be in a “raised state”. Clarification is requested.
Furthermore, regarding the same limitation in Claim 17 above, it is unclear as to whether the “raised state” of the panel would cause the inlet to be “closed” and the “lowered state” of the panel would cause the inlet to be “open”, or the “raised state” of the panel would cause the inlet to be “open” and the “lowered state” of the panel would cause the inlet to be “closed”. Figures 18-19 of the Applicant’s Drawings show that the “raised state” would cause the inlet to be “open”, while Figures 20-21 of the Applicant’s Drawings show that the “raised state” would cause the inlet to be “closed”. Clarification is requested.
Claim 19 recites “first and second pieces of a material and a channel” in lines 4-5. It is unclear as to what exactly this limitation entails, as the limitation could be interpreted in multiple ways, such as “first and second pieces of a material” and a separate “channel” or “first and second pieces”, wherein each of the pieces comprises both “a material and a channel”. Clarification is requested.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 4-5, 8-9, and 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sonkusale et al (WO 2019/178084; cited by Applicant; previously cited).
Regarding Claim 1, Sonkusale discloses an apparatus comprising an orally-administered gut sampler that traverses said gut and that obtains a sample of bacteria from a bacterial population that is present at a selected location within said gut (a gut rover 10 that is suitable for collecting samples of the microbiome as it traverses the gut 12; Page 9 Lines 17-18), said sampler comprising a body that extends from a proximal end to a distal end along a longitudinal axis thereof (A gut rover 10 includes a housing shaped like a capsule or pill so that it can begin its journey along the gut 12 by being swallowed; Page 9 Lines 18-21), wherein said body comprises an inlet (A typical collecting section 16 features one or more inlets 30; Page 10 Lines 19-20) and a sample chamber (The collecting section 16 houses a sampler 28 that is exposed to gut fluid so as to sample microbes that characterize the gut's microbiome; Page 10 Lines 16-18), wherein said gut sampler is further configured to cause said sample of bacteria to begin to pass into said inlet and into said sample chamber when said sampler arrives at said selected location (Fluid from the gut flows into the inlet 30 so that the sampler 28 is able to collect microbes from its environment; Page 10 Lines 20-21), and wherein said gut sampler comprises a valve actuator that is actuated in response to a measurement of a property of an environment in which said gut sampler is located (The timing of sampling can be controlled in other ways. For example, it is possible to delay the start of sampling in the gut using a hydrogel or polymer coating at the inlet of the pill. The composition and thickness of such a coating dictates its dissolution rate, and hence the start of the sampling procedure. On complete dissolution of this coating, the sampling process can be initiated. Delaying the sampling process provides a way to control which areas of the gut are to be sampled. This is particularly useful since the pill's volume is finite, and therefore the pill can only collect a finite sample volume. Another way to control the sampling starting time is to actively do so using an external trigger mechanism. Examples include the use of a reed switch that responds to magnetic field. A reed switch that causes an inlet valve to open can be actuated through thermal, electrochemical, electrical, magnetic, or chemical triggers. An alternative way to trigger the sampling procedure is to have an on-board radio receiver that receives, via a radio signal from an external source, an instruction to begin sampling; Page 6 Lines 5-23).
Regarding Claim 4, Sonkusale discloses wherein said gut sampler further comprises a coating around said body, wherein said coating is configured to begin to dissolve in response to exposure to fluid that is found at said selected location (the pills have been encased in an enteric coating to protect the pill as it passes through the stomach. The coating is configured to dissolve only in the gut, where the pill starts sampling…the timing of sampling can be controlled in other ways. For example, it is possible to delay the start of sampling in the gut using a hydrogel or polymer coating at the inlet of the pill. The composition and thickness of such a coating dictates its dissolution rate, and hence the start of the sampling procedure. On complete dissolution of this coating, the sampling process can be initiated. Delaying the sampling process provides a way to control which areas of the gut are to be sampled. This is particularly useful since the pill's volume is finite, and therefore the pill can only collect a finite sample volume; Page 6 Lines 1-14).
Regarding Claim 5, Sonkusale discloses wherein said gut sampler further comprises a channel (collection channel 54) and an osmotic membrane (semi-permeable membrane 52), wherein said channel extends distally from said inlet to said osmotic membrane (a collection channel 54 coupled to the inlet 30 with a semi-permeable membrane 52; Page 16 Lines 15-16; Examiner’s Note: Figure 7 shows wherein collection channel 54 extends distally from inlet 30, and wherein collection channel 54 extends to semi-permeable membrane 52), and wherein said sample chamber is distal to said osmotic membrane (Examiner’s Note: Figure 7 shows wherein said collecting section 16 is distal to semi-permeable membrane 52).
Regarding Claim 8, Sonkusale discloses wherein said gut sampler further comprises a magnet (The instrument section 14 houses a magnet 18 to enable the gut rover 10 to be moved or oriented by application of a magnetic field from outside the body…magnet 18 also permits the gut rover 10 to be held at a location within the gut 12 for an extended sampling period or to be moved backwards against peristaltic flow to re-sample an upstream section of the gut 12; Page 10 Lines 1-8).
Regarding Claim 9, Sonkusale discloses wherein said gut sampler further comprises a valve and a controller configured to control actuation of said valve (Another way to control the sampling starting time is to actively do so using an external trigger mechanism. Examples include the use of a reed switch that responds to magnetic field. A reed switch that causes an inlet valve to open can be actuated through thermal, electrochemical, electrical, magnetic, or chemical triggers; Page 6 Lines 15-23).
Regarding Claim 11, Sonkusale discloses wherein said gut sampler further comprises a fluorescent marker (To more easily identify the rover 10 in the feces, it is useful to provide a fluorescent dye or to have the outer surface be of a particularly conspicuous color, and in particular, to avoid brown; Page 5 Lines 13-16).
Regarding Claim 12, Sonkusale discloses wherein said gut sampler further comprises a plurality of inlets (A typical collecting section 16 features one or more inlets 30; Page 10 Lines 19-20) of which said inlet is a first inlet of said plurality of inlets (first inlet of one or more inlets 30), a stilling basin into which said inlets of said plurality of inlets open (a stilling chamber), an osmotic membrane (semipermeable membrane 52), and a plurality of channels (collection channels 54), wherein each of said channels extends distally from said stilling basin to said osmotic membrane (a stilling chamber between the beginning of the collection channel 54 and outer surface of the rover 10 so that fluid from the gut passes through the inlet 30 and into the stilling chamber before entering the collection channel 54; Page 16 Lines 25-29), and wherein said sample chamber is distal to said osmotic membrane (Examiner’s Note: Figure 7 shows wherein said collecting section 16 is distal to semi-permeable membrane 52).
Regarding Claim 13, Sonkusale discloses wherein said gut sampler comprises a screw (screw 80) and a motor (motor 64) coupled to said screw to cause rotation of said screw (shown in FIG. 12, features a power source 66 that powers a motor 64 that rotates a screw 80 within a cylindrical cavity to draw gut fluid through the inlet 30 into the collection chamber 56 and to expel gut fluid through the outlet 32 with a collected sample 86 having been retained in the collection chamber 56; Page 19 Line 29 – Page 20 Line 4).
Regarding Claim 14, Sonkusale discloses wherein said gut sampler comprises a screw (screw 80), a motor (motor 64), and a tube (Examiner’s Note: Figure 12 shows a tube (unlabeled) through which motor 64 and screw 80 extend), wherein said screw extends from said inlet to said motor (Examiner’s Note: Screw 80 extends from inlet 30 to motor 64 in Figure 12), wherein said tube extends from said inlet to a point proximal to said motor where said tube is in fluid communication with said sample chamber (Examiner’s Note: Figure 12 shows the extension of the unlabeled tube from inlet 30 to point proximal to motor 64 in fluid communication with collection chamber 56), wherein said screw passes through said tube (Examiner’s Note: Screw 80 extends through unlabeled tube in Figure 12), wherein said motor rotates said screw about said longitudinal axis (shown in FIG. 12, features a power source 66 that powers a motor 64 that rotates a screw 80 within a cylindrical cavity to draw gut fluid through the inlet 30 into the collection chamber 56 and to expel gut fluid through the outlet 32 with a collected sample 86 having been retained in the collection chamber 56; Page 19 Line 29 – Page 20 Line 4), and wherein said screw, when being rotated by said motor, draws sample through said tube and into said sample chamber (shown in FIG. 12, features a power source 66 that powers a motor 64 that rotates a screw 80 within a cylindrical cavity to draw gut fluid through the inlet 30 into the collection chamber 56 and to expel gut fluid through the outlet 32 with a collected sample 86 having been retained in the collection chamber 56; Page 19 Line 29 – Page 20 Line 4).
Claims 1, 4, and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wrigglesworth et al (U.S. Publication No. 2017/0252016; cited by Applicant; previously cited).
Regarding Claim 1, Wrigglesworth discloses an apparatus (sampling device 100; [0040]) comprising an orally-administered gut sampler that traverses said gut and that obtains a sample of bacteria from a bacterial population that is present at a selected location within said gut (the device 100 is designed to withstand any pressure (such as chewing) and/or change in environment. In particular, the device 100 is designed to travel along the gastrointestinal tract of an animal. The device 100 must be able to withstand peristalsis of the gastrointestinal tract, as well as the chemical and mechanical environment of the gastrointestinal tract; [0044]), said sampler comprising a body that extends from a proximal end to a distal end along a longitudinal axis thereof (Figures 1A-1B), wherein said body comprises an inlet (opening 106) and a sample chamber (chamber 104), wherein said gut sampler is further configured to cause said sample of bacteria to begin to pass into said inlet and into said sample chamber when said sampler arrives at said selected location (an internal substance to be drawn in through the opening 106 into the chamber 104…space or volume for receiving and storing a sample within the chamber 104 of the sampling device 100; [0040]), and wherein said gut sampler comprises a valve actuator that is actuated in response to a measurement of a property of an environment in which said gut sampler is located (the sampling device 100 can comprise a retention means 112 that is a material that reacts to pH, temperature, light, moisture, solute concentration or enzyme activity or concentration. In particular, the material can be degradable, digestible or soluble. The material may surround the entire device 100 or may partially cover only certain parts of the device 100 or be located at a particular part of the device. The material may be located and/or cover the end of the device 100 which ejects the separate compartment 110. The material may also cover the opening 106, for example the inlet, outlet 106B and/or inlet 106 and outlet 106B. In particular, the material may be in the form of a coating, pin and/or washer; [0163-0168]).
Regarding Claim 4, Wrigglesworth discloses wherein said gut sampler further comprises a coating around said body, wherein said coating is configured to begin to dissolve in response to exposure to fluid that is found at said selected location (the sampling device 100 can comprise a retention means 112 that is a material that reacts to pH, temperature, light, moisture, solute concentration or enzyme activity or concentration. In particular, the material can be degradable, digestible or soluble. The material may surround the entire device 100 or may partially cover only certain parts of the device 100 or be located at a particular part of the device. The material may be located and/or cover the end of the device 100 which ejects the separate compartment 110. The material may also cover the opening 106, for example the inlet, outlet 106B and/or inlet 106 and outlet 106B. In particular, the material may be in the form of a coating, pin and/or washer; [0163-0168]).
Regarding Claim 6, Wrigglesworth discloses wherein said gut sampler further comprises first and second pieces of a material (tether 116 and closure means 118) and a channel, wherein said channel connects to said inlet (Figures 1B, 2A-2B, 3, 4 show that there is a channel connected to the opening/inlet 106), wherein said first piece forms a first plug that blocks said channel and second piece located so as to be transformable into a second plug that blocks said channel (the tether 116 is drawn though opening 106 of the device 100. A closure means 118 is attached at a point on the tether 116 that serves to block the opening 106 of the device 100, when the actuation means 108 is completely extended; [0262]; Examiner’s Note: The Examiner notes wherein the limitation “so as to be transformable into a second plug that blocks said channel” is a recitation of the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, the claimed element is transformable, as it is “capable of being transformed”, which is the definition of “transformable”).
Claims 1, 4, 7, 9, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Singh et al (U.S. Publication No. 2018/0164221; previously cited).
Regarding Claim 1, Singh discloses an apparatus comprising an orally-administered gut sampler (ingestible device) that traverses said gut and that obtains a sample of bacteria from a bacterial population that is present at a selected location within said gut (the method comprises collecting the sample from the GI tract of a subject; [0125]), said sampler comprising a body that extends from a proximal end to a distal end along a longitudinal axis thereof (the ingestible device, comprises: a housing defined by a first end, a second end substantially opposite from the first end, and a wall extending longitudinally from the first end to the second end; [0128]), wherein said body comprises an inlet (a first opening in the wall of the housing; [0128]) and a sample chamber (a curved chamber connecting the first opening and the second opening, wherein at least a portion of the curved chamber forms a sampling chamber within the ingestible device; [0128]), wherein said gut sampler is further configured to cause said sample of bacteria to begin to pass into said inlet and into said sample chamber when said sampler arrives at said selected location ([0125-0132]), and wherein said gut sampler comprises a valve actuator that is actuated in response to a measurement of a property of an environment in which said gut sampler is located (The ingestible device 200 includes a mechanical actuator 218 coupled to the valves 214 and 216. In some embodiments, the mechanical actuator 218 is used to move one or both of the valves 214 and 216 between an open and a closed position…a microcontroller on board the ingestible device 200 may be configured to open the valves 214 and 216 only when the ingestible device 200 is within the small intestine, thereby obtaining a sample from within the small intestine; [1014-1016]).
Regarding Claim 4, Singh discloses wherein said gut sampler further comprises a coating around said body, wherein said coating is configured to begin to dissolve in response to exposure to fluid that is found at said selected location (the housing of ingestible device 4000 may have a pH-sensitive enteric coating to detect or otherwise be sensitive to a pH level of the environment external to the ingestible device 4000, based on which the controller may determine whether the ingestible device has arrived at a target location; [1127]).
Regarding Claim 7, Singh teaches gastrointestinal tract detection methods, devices and systems (Abstract), wherein said gut sampler further comprises a valve (one-way valve; [1031]) and a pair of electric heaters that are disposed to heat first and second portions of said valve (each of the sub-chambers may be opened by activating their respective heating elements, and may be automatically sealed off from the sampling chamber 304 after a sufficient amount of the sample has been obtained. In general, any type of valve or other suitable mechanism may be used to isolate samples contained in the sub-chambers; [1031]).
Regarding Claim 9, Singh discloses wherein said gut sampler further comprises a valve and a controller configured to control actuation of said valve (The ingestible device 200 includes a mechanical actuator 218 coupled to the valves 214 and 216. In some embodiments, the mechanical actuator 218 is used to move one or both of the valves 214 and 216 between an open and a closed position…a microcontroller on board the ingestible device 200 may be configured to open the valves 214 and 216 only when the ingestible device 200 is within the small intestine, thereby obtaining a sample from within the small intestine; [1014-1016]).
Regarding Claim 20, Singh teaches wherein said gut sampler comprises a photodetector (ingestible device 65100 may have various sensors and illuminators located within the housing 65102, and behind the transparent window 65114. This may allow ingestible device 65100 to be configured to transmit illumination at different wavelengths through transparent window 65114 to an environment external to housing 65102 of ingestible device 65100, and to detect a reflectance from a portion of the illumination that is reflected back through transparent window 65114 from the environment external to housing 65102. Ingestible device 65100 may then use the detected level of reflectance in order to determine a location of ingestible device 65100 within a GI tract…ingestible device 65100 may have multiple sets of sensors and illuminators positioned at different locations azimuthally behind window 65114; [1199]; detector 65122; [1202-1204]; The diffracted light can be detected using any appropriate light detector(s). Examples of light detectors include photodetectors; [1587]), a light source (ingestible device 65100 may have various sensors and illuminators located within the housing 65102…ingestible device 65100 may have multiple sets of sensors and illuminators positioned at different locations azimuthally behind window 65114; [1199]; illuminator 65124; [1202-1204]), a dye source ([0061-0074]), and a controller that receives a signal from said photodetector (microcontroller…PCB 65120 may include a detector 65122 and an illuminator 65124, which together form sensing sub-unit 65126; [1202]), wherein said light source is configured to illuminate a dye released by said dye source and said photodetector is disposed to view said dye and to provide a signal indicative of a state of said dye (sensing sub-unit 65126 may be configured to generate an illumination using illuminator 65124, which is directed through the window 65114 in a radial direction away from ingestible device 65100. This illumination may reflect off of the environment external to ingestible device 65100, and the reflected light coming back into ingestible device 65100 through window 65114 may be detected as a reflectance by detector 65122; [1202]; the illumination source may provide diffuse illumination to the dye. For example, an array of multiple point light sources (e.g., LEDs) may simply be employed to provide relatively diffuse illumination…the detector may be any device known in the art that is capable of sensing a signal; [1378-1379]).
Claims 1-2, 4, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shalon (U.S. Patent No. 12,096,920; previously cited).
Regarding Claim 1, Shalon discloses an apparatus comprising an orally-administered gut sampler (device 10) that traverses said gut and that obtains a sample of bacteria from a bacterial population that is present at a selected location within said gut (tube-shaped body 12 with a radially collapsed lumen forming collecting member 18 is packed tightly and randomly inside an external body to maximize the volume of collected sample per the volume of device 10 before swallowing; Column 31 Lines 56-60), said sampler comprising a body that extends from a proximal end to a distal end along a longitudinal axis thereof (capsule 72), wherein said body comprises an inlet (sampling opening 42 of body 12) and a sample chamber (collecting member 18 of body 12), wherein said gut sampler is further configured to cause said sample of bacteria to begin to pass into said inlet and into said sample chamber when said sampler arrives at said selected location (body 12 comprises a tube that is coiled, spooled, twisted, folded or compressed tightly enough inside capsule 72 to elastically or reversibly collapse the hollow lumen within body 12 that forms collecting member 18…the collapsed collecting member is placed inside capsule 72 in such a manner that capsule 72 prevents the collapsed lumen of body 12 from expanding radially. Capsule 72 or body 12 can be coated or comprise enteric degradable covering element 30. When capsule 72 dissolves or degrades, the collapsed lumen of body 12 starts to transition to its normal relaxed circular cross sectional shape with an expanded hollow space that forms collecting member 18. The hollow space forming collecting member 18 is opened either due to elastic nature of body 12 material or due to capillary forces of liquid collected therein. As body 12 unwinds, untwists, unfolds or expands, liquid and gas gastrointestinal samples are sucked through sampling opening 42 inside collecting member 18 and collected therein; Column 30 Line 49 – Column 31 Line 10), and wherein said gut sampler comprises a valve actuator that is actuated in response to a measurement of a property of an environment in which said gut sampler is located (The device can comprise a covering element. In some embodiments, the device comprises a pH sensitive degradable covering element configured to cover the opening. The device can comprise a second opening covered by a second pH sensitive degradable covering element. In another aspect, a device for collecting gastrointestinal samples is provided. The device comprises a body; an opening in fluid communication with the body configured to allow gastrointestinal samples to enter the body; and an external pH sensitive degradable covering element covering the opening; and an internal pH sensitive degradable covering element covering the opening; Column 4 Lines 43-55; Column 19 Lines 34-65).
Regarding Claim 2, Shalon discloses wherein said gut sampler further comprises a channel that extends from said inlet to said sample chamber (channel between sampling opening 42 of body 12 and collecting member 18 of body 12), wherein said sample chamber comprises a bag having a volume that has been reduced as a result of having been folded within said body (body 12 comprises a tube that is coiled, spooled, twisted, folded or compressed tightly enough inside capsule 72 to elastically or reversibly collapse the hollow lumen within body 12 that forms collecting member 18…the collapsed collecting member is placed inside capsule 72 in such a manner that capsule 72 prevents the collapsed lumen of body 12 from expanding radially. Capsule 72 or body 12 can be coated or comprise enteric degradable covering element 30. When capsule 72 dissolves or degrades, the collapsed lumen of body 12 starts to transition to its normal relaxed circular cross sectional shape with an expanded hollow space that forms collecting member 18. The hollow space forming collecting member 18 is opened either due to elastic nature of body 12 material or due to capillary forces of liquid collected therein. As body 12 unwinds, untwists, unfolds or expands, liquid and gas gastrointestinal samples are sucked through sampling opening 42 inside collecting member 18 and collected therein; Column 30 Line 49 – Column 31 Line 10).
Regarding Claim 4, Shalon discloses wherein said gut sampler further comprises a coating around said body, wherein said coating is configured to begin to dissolve in response to exposure to fluid that is found at said selected location (The device can comprise a covering element. In some embodiments, the device comprises a pH sensitive degradable covering element configured to cover the opening. The device can comprise a second opening covered by a second pH sensitive degradable covering element. In another aspect, a device for collecting gastrointestinal samples is provided. The device comprises a body; an opening in fluid communication with the body configured to allow gastrointestinal samples to enter the body; and an external pH sensitive degradable covering element covering the opening; and an internal pH sensitive degradable covering element covering the opening; Column 4 Lines 43-55; Column 19 Lines 34-65).
Regarding Claim 9, Shalon discloses wherein said gut sampler further comprises a valve and a controller configured to control actuation of said valve (In further embodiments, the common connection point of the spoke elements comprises discrete sample openings, seals and/or valves connected to individual collecting members 18 units. As illustrated in FIG. 20 in a magnified cut away side view of one collecting member 18, opening 42 is covered by covering element 30. Seal 38 acts as a one-way valve to prevent collected samples in collecting member 18 from exposure to cross contamination or leakage during the rest of the transit through the GI tract. In this manner, a negative pressure differential inside collecting member 18 relative to the GI tract, for example by radial expansion of an elastically collapsed or evacuated collecting member 12, or alternatively capillary pressure alone, drives fluids into collecting member 18. The collected GI samples cannot flow back out via the one-way valve. Examples of one-way valves comprise flap valve, lay flat tubing, duck bill valve, umbrella valve, ball valve, dome valve, Belleville valve, and cross-slit valve. In some embodiments, the rate of sampling is controlled by the balance of two forces. The first force is the force of radial expansion of the compressed tube shaped body 12, which creates a pressure differential that drives fluid through sampling opening 42 into collecting member 18. The second opposing force is the resistance to flow through the one way valve in the forward flow direction. One way valves are generally biased closed to prevent flow in the backward direction when there is no pressure differential across the valve. The forward pressure required to open the valve is called the cracking pressure. The cracking pressure is the first component of the resistance to flow. The second component of the resistance to flow is the size of the opening(s) of the one way valve. The third component of the resistance to flow is the force of the sealing element acting to close the one way valve. All three components act together to create the resistance to forward flow in a one way valve; Column 23 Lines 21-56).
Claims 1, 4, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jones (U.S. Publication No. 2020/0121302; cited by Applicant; previously cited).
Regarding Claim 1, Jones discloses an apparatus comprising an orally-administered gut sampler that traverses said gut and that obtains a sample of bacteria from a bacterial population that is present at a selected location within said gut (a gastrointestinal sampling device 1; [0038]), said sampler comprising a body that extends from a proximal end to a distal end along a longitudinal axis thereof (a gastrointestinal sampling device 1 may have an open configuration length of approximately 24 mm and a closed configuration length of approximately 20 mm…the volume of the enclosed sample may be approximately 0.50 ml or eight (8) drops of fluid sample; [0038), wherein said body comprises an inlet (ports 21) and a sample chamber (chamber enclosed by walls 26 and 27), wherein said gut sampler is further configured to cause said sample of bacteria to begin to pass into said inlet and into said sample chamber when said sampler arrives at said selected location (The number of ports 21, their size, shape, or their configuration on the casings may be varied to satisfy sample collection or material delivery efficacy. However, it should be noted that the casing walls 26 and 27 are of such lengths L1 and L2 so as to cover and effectively seal the ports 21 in the other casing's walls such that all of the holes 21 in the gastrointestinal sampling device are fluid tight such that the sample enclosed therein does not leak out after the time of closing; [0039]), and wherein said gut sampler comprises a valve actuator that is actuated in response to a measurement of a property of an environment in which said gut sampler is located (Because stomach acid ranges from a pH of 1-3.5, the outer capsule 10 may necessarily need to be acid resistant below a 3.5 pH from a few minutes for liquids to five hours for meat and high fat substances. Thickness and material can adjust for this timing. The digestible outer capsule 10 is an excipient that dissolves in the stomach or intestines in a desired timeframe providing fluid access to and through the normally open ports 21 of the gastrointestinal sampling device 1. The fluid flow here comprises local community microbiota along with their environment including ingesta, loosely adherent mucus layer particles, and bodily chemistries into the gastrointestinal sampling device 1; [0055-056]).
Regarding Claim 4, Jones discloses wherein said gut sampler further comprises a coating around said body, wherein said coating is configured to begin to dissolve in response to exposure to fluid that is found at said selected location (Because stomach acid ranges from a pH of 1-3.5, the outer capsule 10 may necessarily need to be acid resistant below a 3.5 pH from a few minutes for liquids to five hours for meat and high fat substances. Thickness and material can adjust for this timing. The digestible outer capsule 10 is an excipient that dissolves in the stomach or intestines in a desired timeframe providing fluid access to and through the normally open ports 21 of the gastrointestinal sampling device 1. The fluid flow here comprises local community microbiota along with their environment including ingesta, loosely adherent mucus layer particles, and bodily chemistries into the gastrointestinal sampling device 1; [0055-0056]).
Regarding Claim 16, Jones discloses wherein said gut sampler comprises a panel that translates along said longitudinal axis between first and second positions that are offset from each other along said longitudinal axis (outer casing 4; Figure 14; [0056]), wherein, in said first position, said panel closes said inlet (The digestible outer capsule 10 is an excipient that dissolves in the stomach or intestines in a desired timeframe providing fluid access to and through the normally open ports 21 of the gastrointestinal sampling device 1. The fluid flow here comprises local community microbiota along with their environment including ingesta, loosely adherent mucus layer particles, and bodily chemistries into the gastrointestinal sampling device 1. The fluid flow enters the gastrointestinal sampling device 1, envelopes the dissolvable, non-toxic strut 24 causing it to fail structurally, which in turn allows the tension provided by the elastomeric filament 23 to pull or slide the inner casing 2 further into the outer casing 4 and hold gastrointestinal sampling device 1 in a closed, sealed port position (see, FIG. 13); [0056]), and wherein, in said second position, said panel opens said inlet (The digestible outer capsule 10 is an excipient that dissolves in the stomach or intestines in a desired timeframe providing fluid access to and through the normally open ports 21 of the gastrointestinal sampling device 1; [0056]; Examiner’s Note: Figure 12 shows the open configuration).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Wrigglesworth in view of Shalon.
Regarding Claim 3, Wrigglesworth discloses wherein said gut sampler further comprises a channel (Figure 1B shows channel between opening 106 and chamber 104) and a valve (the inlet opening 106 can comprise a valve; [0069]), wherein said channel extends between said inlet and said sample chamber (Figure 1B shows channel between opening 106 and chamber 104), wherein said valve is biased to block said channel, and thereby causing a pressure differential across said valve, said pressure differential being sufficient to open said valve and diminishing over time such that said valve closes when said pressure differential is no longer sufficient to overcome said bias (the inlet opening 106 can comprise a valve. The valve can be any valve known in the art and will depend on the use of the sampling device 100. The valve includes an aperture. The valve can be made from rubber or synthetic elastomer. Preferably, the valve is made of elastomer which is resistant to low pressure therefore opening the aperture. In other embodiments, the opening 106 can be an inlet and an outlet 106A. The opening can be a two way valve. Most preferably, the opening 106 is a one-way valve; [0069]).
Wrigglesworth fails to specifically disclose wherein said sample chamber is configured to expand in volume.
In a similar technical field, Shalon teaches devices and methods for collecting gastrointestinal samples (Abstract), wherein said sample chamber is configured to expand in volume (tube-shaped body 12 with a radially collapsed lumen forming collecting member 18 is packed tightly and randomly inside an external body to maximize the volume of collected sample per the volume of device 10 before swallowing; Column 31 Lines 56-60; body 12 comprises a tube that is coiled, spooled, twisted, folded or compressed tightly enough inside capsule 72 to elastically or reversibly collapse the hollow lumen within body 12 that forms collecting member 18…the collapsed collecting member is placed inside capsule 72 in such a manner that capsule 72 prevents the collapsed lumen of body 12 from expanding radially. Capsule 72 or body 12 can be coated or comprise enteric degradable covering element 30. When capsule 72 dissolves or degrades, the collapsed lumen of body 12 starts to transition to its normal relaxed circular cross sectional shape with an expanded hollow space that forms collecting member 18. The hollow space forming collecting member 18 is opened either due to elastic nature of body 12 material or due to capillary forces of liquid collected therein. As body 12 unwinds, untwists, unfolds or expands, liquid and gas gastrointestinal samples are sucked through sampling opening 42 inside collecting member 18 and collected therein; Column 30 Line 49 – Column 31 Line 10) thereby causing a pressure differential across said valve, said pressure differential being sufficient to open said valve and diminishing over time such that said valve closes when said pressure differential is no longer sufficient to overcome said bias (In some embodiments, movement of gastrointestinal samples into the tube-shaped body is driven by a pressure differential between a radially collapsed and radially expanded body. In some embodiments, the open end of the tube-shaped body can comprise a one way valve. The cracking pressure of the one way valve can be in the range of about 0.03 to 15 pounds per square inch. The maximal outward radial pressure exerted by expanding tube-shaped body can be in the range of about 10 to 150 grams-force per cm length of body. The flow of fluid sample through the open end of the body can be between 1 to 500 microliters per hour; Column 1 Line 59 – Column 2 Line 3; In further embodiments, the common connection point of the spoke elements comprises discrete sample openings, seals and/or valves connected to individual collecting members 18 units. As illustrated in FIG. 20 in a magnified cut away side view of one collecting member 18, opening 42 is covered by covering element 30. Seal 38 acts as a one-way valve to prevent collected samples in collecting member 18 from exposure to cross contamination or leakage during the rest of the transit through the GI tract. In this manner, a negative pressure differential inside collecting member 18 relative to the GI tract, for example by radial expansion of an elastically collapsed or evacuated collecting member 12, or alternatively capillary pressure alone, drives fluids into collecting member 18. The collected GI samples cannot flow back out via the one-way valve. Examples of one-way valves comprise flap valve, lay flat tubing, duck bill valve, umbrella valve, ball valve, dome valve, Belleville valve, and cross-slit valve. In some embodiments, the rate of sampling is controlled by the balance of two forces. The first force is the force of radial expansion of the compressed tube shaped body 12, which creates a pressure differential that drives fluid through sampling opening 42 into collecting member 18. The second opposing force is the resistance to flow through the one way valve in the forward flow direction. One way valves are generally biased closed to prevent flow in the backward direction when there is no pressure differential across the valve. The forward pressure required to open the valve is called the cracking pressure. The cracking pressure is the first component of the resistance to flow. The second component of the resistance to flow is the size of the opening(s) of the one way valve. The third component of the resistance to flow is the force of the sealing element acting to close the one way valve. All three components act together to create the resistance to forward flow in a one way valve; Column 23 Lines 21-56).
Accordingly, it would have been obvious to a person having ordinary skill in the art to have incorporated the expandable body teachings of Shalon into the apparatus of Wrigglesworth, in order to provide a dual advantage of limiting the sampling rate (thus reducing collection of gas as compared to prior art devices) and providing a much larger volume collecting member 18 within the confined space provided by a swallowable capsule (Shalon Column 30 Lines 33-38).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Sonkusale in view of Dal Molin et al (U.S. Patent No. 8,255,048; cited by Applicant; previously cited).
Regarding Claim 10, Sonkusale fails to teach wherein said gut sampler further comprises a voltage source, switches, and resistances, wherein said switches transition into a closed state that permits current driven by said voltage source to flow through said resistances.
In a similar technical field, Dal Molin teaches a circuit for controlled commutation of multiplexed electrodes, for an active implantable medical device (Abstract), comprising a voltage source (voltage across circuit 22; Fig. 3; Col 5 Lines 4-40), switches (switch(es) 36; Fig. 3; Col 5 Lines 4-40), and resistances (resistor 38; Fig. 3; Col 5 Lines 4-40), wherein said switches transition into a closed state that permits current driven by said voltage source to flow through said resistances (closing of switch(es) 36 to complete circuit; Fig. 3; Col 5 Lines 4-55; Examiner’s Note: The Examiner notes wherein the limitation “that permits current driven by said voltage source to flow through said resistances” is a recitation of the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations).
Accordingly, it would have been obvious to a person having ordinary skill in the art to have employed the circuit of Dal Molin upon the apparatus of Sonkusale, in order to effectively remotely control the opening and closing operation of the apparatus.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Sonkusale in view of Casper et al (U.S. Patent No. 5,170,801; cited by Applicant; previously cited).
Regarding Claim 15, Sonkusale fails to teach a panel that rotates about said longitudinal axis between first and second positions, wherein, in said first position, said panel opens said inlet, and wherein, in said second position, said panel closes said inlet.
In a similar technical field, Casper teaches a medical capsule device (Abstract), comprising a panel that rotates about said longitudinal axis between first and second positions (Capsule device 10 includes a capsule body 12 and a sleeve member 14 which is slidably received and rotatably mounted within capsule body 12; Column 3 Lines 27-29; Figures 1-2), wherein, in said first position, said panel opens said inlet (apertures 12A, 14A; Figures 1-2), and wherein, in said second position, said panel closes said inlet (As can now be appreciated, actuator mechanism 16 and sleeve member 14 essentially serve as a sleeve valve to release a drug or other substance from the reservoir space in capsule device 10 defined generally between the lower compartment of sleeve member 14 and capsule body 12. Shape memory alloy fingers 16I, 16J will tend to straighten when acted on by heat from resistive heaters 16D-16F and by applying force against retainer wires 20 (see FIGS. 5A-5B and 6A-6B) will thus serve to rotate sleeve member 14 within capsule body 12. This movement opens the capsule by positioning apertures 14A of sleeve member 14 and apertures 12A of capsule body 12 in circumferential registration. The sleeve valve takes advantage of the relatively large aperture area which may be achieved with only a small rotational relative displacement of sleeve member 14 within capsule body 12. Though the instant invention may be made with only a single through-put aperture in capsule device 10, preferably a plurality of apertures are provided around the circumference of sleeve member 14 and capsule body 12 to (1) assure that the release time of a drug carried thereby is not dependent on the orientation of the capsule device in the gastrointestinal tract and (2) to decrease the possible negative effects of high drug concentration on the gastrointestinal mucosa; Column 4 Lines 38-62).
Accordingly, it would have been obvious to a person having ordinary skill in the art to have employed the rotating panel of Casper upon the apparatus of Sonkusale, in order to effectively collect and retain a desired amount of sample within the chamber without loss.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable in view of Singh et al.
Regarding Claim 18, Singh teaches a panel, wherein said panel is disposed at said proximal end, wherein said inlet is at said proximal end, wherein said panel rotates about said longitudinal axis between first and second positions, wherein, when said panel has been rotated into said first position, said panel opens said inlet, and wherein, when said panel has been rotated into said second position, said panel closes said inlet (Ingestible device 704 illustrates how a rotary valve may be used as a moveable valve (e.g., as moveable valve 614 of ingestible device 600 (FIG. 6)), with diagram 704A showing the rotary valve in a closed position, and diagram 704B showing the rotary valve in an open position. In diagram 704A, the ingestible device 704 has a rotary pin oriented such that the sample is prevented from entering the sampling chamber from the opening in the ingestible device 704. In diagram 704B, the ingestible device 704 has a rotary pin that has been rotated into an orientation where the sample is free to flow into the sampling chamber from the opening in the ingestible device 704. In order to operate the rotary valve, the mechanical actuator in ingestible device 704 may be a rotatory actuator, which is capable of rotating the rotary pin to switch between the open position and the closed position; [1055]).
Although Singh fails to teach wherein said panel is a flat panel, there is no evidence of record that establishes that changing the shape would result in a difference in function of the claimed device. Further, a person having ordinary skill in the art, being faced with modifying the device of Singh would have a reasonable expectation of success in making such a modification and it appears the device would function as intended regardless of the specific shape. Lastly, Applicant has not disclosed that the claimed shape solves any stated problem, as the Applicant’s Specification seems to fail to even recite that the panel is “flat”. Therefore, there appears to be no criticality placed on the shape as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the rotary valve of Singh to comprise a flat panel as an obvious matter of design choice within the skill of the art.
Conclusion
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/CHANEL J YOON/Examiner, Art Unit 3791
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