DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 05/26/2026 has been entered. Amendments to claims 1, 4, and 6 are acknowledged. Claims 1-20 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 02/24/2026.
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) in view of Klemm (US 20200046913 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 a puncturing element operatively coupled to the toroidal reservoir ([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.”); and an actuating mechanism, wherein the actuating mechanism is configured such that triggering the actuating mechanism causes the puncturing element to puncture 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, [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;”, wherein the plug is released by the action of puncturing the reservoir via the actuating mechanism) and further such that the second chamber diminishes to release a liquid therefrom through at least one outlet ([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.
Yang as modified by Mojarrad fails to disclose the second chamber diminishes to release a liquid therefrom through at least one outlet created by the puncturing element puncturing of the toroidal reservoir.
Klemm discloses release of a liquid therefrom through at least one outlet created by the puncturing element puncturing of a reservoir. ([0059]: “the chamber 25 is made with a soft material and in use, the main needle 17 pierces the chamber 25 so that the pain reduction agent can be released towards the micro-needles 19”)
It would have been obvious to a person of ordinary skill in the prior to the effective filing date to modify the device disclosed by Yang as modified by Mojarrad to substitute the known method of releasing liquid from an outlet created by the puncturing element via an actuating mechanism with the known method of releasing liquid from an outlet created directly by the puncturing element as disclosed by Klemm for the predictable result of release of a liquid.
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 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 view of Klemm 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.
Response to Arguments
Applicant’s arguments, see Remarks, filed 05/26/2026, with respect to the rejection(s) of claim(s) 1-20 under 35 U.S.C. § 103 have been fully considered and are persuasive. Applicant argues on pages 9 and 10 of the Remarks that the outlet created by Yang is based on a pre-existing outlet and is thus not created by the puncturing of the reservoir. However, per Yang [0041], the reservoir is sealed by the plug until the needle pierces the rubber layer, thus the deflation of the chamber is effectively caused by the puncturing element. MPEP 2183 states that a prior art element is equivalent when (A) The prior art element performs the identical function specified in the claim in substantially the same way, and produces substantially the same results as the corresponding element disclosed in the specification. Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1364, 54 USPQ2d 1308, 1315 (Fed. Cir. 2000). However, Yang fails to disclose that the outlet is directly created by the puncturing element. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. § 103 (see above).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAVYA SHOBANA BALAJI whose telephone number is (703)756-5368. The examiner can normally be reached Monday - Friday 8:30 - 5:30 ET.
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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