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 .
Claim Objections
Claim 6 is objected to because of the following informalities: “triggereing” is misspelled. 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.
Claim 6 is 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 6 recites the limitation "the inlet of the second chamber" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites an inlet in the first chamber and an outlet in the second toroidal chamber. It is unclear if the claim limitation is referring to the outlet or an additional inlet.
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(s) 1-2, 4, 11, 13-14, 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (CN 109330627 B), hereinafter Yang, in view of Mojarrad et al. (US 20230302264 A1).
Regarding claim 1, Yang discloses an ingestible device for sampling material in a gastrointestinal (GI) tract (title, [0014]: “simultaneously sample and release drugs… digestive tract system”), the ingestible device comprising: a first chamber that is enlargeable in space (Fig 3 element 119, [0034]: "sampling compartment 119", to figure 5 element 119, wherein the sampling compartment expands in space) and that comprises an inlet (Fig 3 element 103, [0051]: "sampling port"); a second chamber comprising a reservoir that is diminishable in space (Fig 3 element 105, [0034]: "drug compartment", to fig 5 element 105, wherein the compartment diminishes in space); and an actuating mechanism, wherein the actuating mechanism is configured such that triggering the actuating mechanism causes the reservoir to deflate such that the first chamber enlarges to collect the material to be sampled through the inlet into the first chamber (Fig 3 element 110 to Fig 5 element 110, [0006]: "spring pushes the sampling device so that the sampling pool is aligned with the sampling hole to start sampling", and Fig 3 element 105, [0034]: "drug compartment", to fig 5 element 105, wherein the compartment diminishes in space) and further such that the second chamber diminishes to release a liquid therefrom through at least one outlet of the toroidal reservoir ( [0036]: "when the spring 110 is released and pushes the piston 108 to release the drug,").
Yang fails to disclose a toroidal reservoir.
Mojarrad discloses an ingestible device (title) including a toroidal reservoir ([0097]: "the reservoir 904 has a hollow cylindrical or annular shape with an outer diameter D1 in the initial state." Fig 9A element 904).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to substitute the known shape of the reservoir disclosed by Yang to the toroidal reservoir disclosed by Mojarrad for the predictable result of containing a sample.
Regarding claim 2, Yang discloses wherein the first chamber collects the material through the inlet due to an under pressure ([0042]: "At this time, because the sampling pool 109 is in a low-pressure state, the external high pressure pushes the liquid into the sampling pool 109."), wherein the inlet is configured to seal once the material is collected ([0006]: "After sampling is completed, the fusible wire is spun out, and the spring continues to push the sampling pool forward, causing the sampling pool opening to be misaligned with the sampling hole, thus sealing the sampling pool"), and wherein the toroidal reservoir in the second chamber releases the liquid therefrom through the at least one outlet due to an over pressure when the second chamber is diminished ([0041]: ", which on the one hand squeezes drug chamber 105, pushes out oil seal or plug in drug release hole 104, and sprays out drug;").
Regarding claim 4, Yang discloses wherein the actuating mechanism comprises: a spring (Fig 3 element 110); and a puncturing element operatively coupled to the toroidal reservoir, wherein the puncturing element is configured to puncture the toroidal reservoir in response to triggering of the actuating mechanism ([0041]: “Spring 110 pushes piston 108, which on the one hand squeezes drug chamber 105, pushes out oil seal or plug in drug release hole 104, and sprays out drug; on the other hand, needle of needle tube 106 pierces rubber layer 107 of piston 108, and sampling pool 109 is connected to the outside through needle tube 106 and sampling port 103.”); wherein the spring is arranged with respect to the toroidal reservoir to apply a force onto the toroidal reservoir such that puncturing the toroidal reservoir leads to the spring decompressing and deflating the toroidal reservoir ([0041], [0042]: “At this time, because the sampling pool 109 is in a low-pressure state, the external high pressure pushes the liquid into the sampling pool 109.”), wherein the spring is arranged with respect to the first chamber such that the first chamber is enlarged by the decompression of the spring ([0041], Fig 3 to Fig 5 element 119), and wherein the spring is arranged with respect to the second chamber such that the second chamber is diminished by the decompression of the spring (Fig 3 to Fig 5 element 105).
Regarding claim 9, Yang discloses wherein a height of the toroidal reservoir when deflated is between 2 millimeters and 3 millimeters and a height of the toroidal reservoir when inflated is between 4 millimeters and 6 millimeters ([0039]: “length of the medicine container 105 along the axial direction of the capsule is preferably 4 to 12 mm”, and Fig 5 wherein the compartment is fully deflated).
Regarding claim 11, Yang discloses wherein the inlet comprises a passive one-way valve ([0042]).
Regarding claim 13, Yang discloses wherein at least one of: (i) the material comprises gastrointestinal content ([0014]), or (ii) the liquid comprises a drug ([0034]).
Regarding claim 14, Yang discloses wherein at least a part of an internal space of the first chamber comprises a stabilizing substance configured to prevent the material from undergoing additional chemical reactions ([0042]: "In its initial state, the syringe 106 is filled with mineral oil, etc., which can prevent external liquids from slowly flowing into the syringe along the connection port of the syringe 106, causing the sample to be drawn into the sampling pool along with the sample and contaminating the sample.").
Regarding claim 16, Yang discloses an energy source for supplying electric power to the actuating mechanism; a remote trigger unit that is configured to receive at least one remote trigger signal in order to trigger the actuating mechanism; a data recording unit for recording at least one of environment data or localization data; or a wireless data transmission unit configured to wirelessly transmit data ([0034]: “communication module”)
Regarding claim 17, Yang discloses wherein the body portion comprises at least one sensor ([0034]: “The capsule sensing and control module 115 is integrated with a pH sensor, an image sensor”).
Regarding claim 18, Yang discloses wherein the ingestible device has a shape of a pill or a cylinder (Fig 3, wherein the capsule is pill shaped).
Regarding claim 19, Yang discloses wherein a length of the ingestible device is less than 24 millimeters following triggering of the actuating mechanism ([0038]: “the length of the capsule shell 101 is in the range of 20-30 mm,”).
Regarding claim 20, Yang discloses wherein a diameter of the ingestible device is less than 9 millimeters ([0038]: “and the diameter is in the range of 9-12mm).
Claim(s) 5-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Mojarrad in further view of John et al. (US 20250025675 A1), hereinafter John.
Regarding claim 5, Yang as modified by Mojarrad discloses the device of claim 1. Yang further discloses, wherein the toroidal reservoir comprises: a base part having an opening (Fig 3 element 120 and the hole formed by element 106); and a stretchable sheet positioned on top of the base part ([0036]: “rubber membrane 107”), wherein the stretchable sheet is configured to inflate when filled with the liquid ( Fig 3, wherein the sample chamber is filled, and consistent with applicant's specification para [0048]: "the term "inflated" is referred to as filling the toroidal reservoir 2 or the further toroidal reservoir "), wherein the stretchable sheet is configured to deflate when the stretchable sheet is punctured (Fig 5 to Fig 6, [0034]: “The needle of the syringe 106 can pierce the rubber layer 107”).
Yang as modified by Mojarrad fails to disclose an umbrella valve disposed in the opening of the base part.
John discloses an ingestible device (abstract) including an umbrella valve ([0274]: “The valve may be, for example, an umbrella valve” ) disposed in the opening of a base part ( [0273]: “A sealed chamber at least partially formed by the elastic material membrane 722 or formed by a balloon may be filled at manufacture and provided to clinicians loaded with the therapeutic matter, and sealed… via a one-way valve at the balloon aperture”).
It would have been obvious to a person of ordinary skill in the art prior the effective filing date to modify the device disclosed by Yang as modified by Mojarrad to include the umbrella valve disposed in the opening of a base part disclosed by John in order to allow the chamber to be filled with fluid while forming a seal to the environment external to it (John [0274]).
Regarding claim 6, John further discloses wherein the toroidal reservoir is fillable with the liquid through the umbrella valve , which is coupled to the inlet of the second chamber ([0273]: “the sealed chamber may be filled at clinician or pharmacy via a mechanism such as a syringe or equivalent configured to insert content into the balloon via a one-way valve at the balloon aperture.”), and wherein the umbrella valve prevents the liquid from flowing out of the toroidal reservoir prior to triggering of the actuating mechanism ([0273]: “allow for the sealed chamber to be filled with fluid while forming a seal between the interior of the balloon and the environment external to the balloon.”).
Regarding claim 7, Yang further discloses wherein an inner diameter of the base part is between 3 millimeters and 7 millimeters and an outer diameter of the base part is between 7 millimeters and 12 millimeters 9 millimeters ([0038]: “and the diameter is in the range of 9-12mm).
Regarding claim 8, Yang discloses the invention essentially as claimed as discussed above and further discloses the wherein a diameter of the umbrella valve is less than a few millimeters ([0038]: “and the diameter is in the range of 9-12mm”)
However, Yang does not expressly disclose herein a diameter of the umbrella valve between 2.5 millimeters and 6.5 millimeters.
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 diameter disclosed in Yang to between 2.5 millimeters and 6.5 millimeters as applicant appears to have placed no criticality on the claimed range (see applicant’s specification [0027]) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 9, Yang further discloses a height of the toroidal reservoir when deflated is between 2 millimeters and 3 millimeters and a height of the toroidal reservoir when inflated is between 4 millimeters and 6 millimeters. ([0039]: “length of the medicine container 105 along the axial direction of the capsule is preferably 4 to 12 mm”)
Allowable Subject Matter
Claims 3 and 10 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Quintana et al. (US 20250195855 A1) – discloses an ingestible capsule
Wang et al. (US 20140371674 A1) – discloses a stretchable sheet
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791