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 amendments and remarks, filed on 2/9/2026, has been entered. The claim amendments overcome the previous 112(b) rejection of claim 6.
The amendments and remarks, filed on 2/9/2026, has been entered. The claim amendments do not overcome the previous prior art rejection, and the prior art rejection is applied to address the claim amendments.
Claim Status
Claims 1-20 are pending and being examined.
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 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.
Claim(s) 1-5 and 7-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shimada et al (US 20190011462 A1; hereinafter “Shimada”; already of record).
Regarding claim 1, Shimada teaches a vial adapted for preservation of a metabolite profile of a fecal sample during transport thereof (Shimada; Abstract; para [7]; feces sampling container…provide a feces sampling container to increase a storage stability of a component, such as hemoglobin, in a feces sample and to measure the component in a feces sample with a small amount of feces collected), the vial comprising:
a body comprising a volume of preservative (Shimada; Fig. 1; para [40, 53]; the aqueous medium for dissolving a component in a feces sample…a feces sampling container comprising a pierce part 14 for introducing an aqueous medium for dissolving a component in a feces sample in a top part of a fitting body 10); and,
a cap configured to engage with the body and to seal sample fluid comprising a mixture of the preservative and fecal sample within the vial during transport by a common carrier1 (Shimada; Fig. 1; para [33]; In order to impart the airtight function to the feces sampling stick having the gripping part as a cap member, it is possible to provide a screw part at the base end of the stick part of the feces sampling stick and install the feces sampling stick in an airtight condition by screwing and inserting the feces sampling stick in the inner peripheral surface of the opening part of the container body);
wherein once the body and the cap have been sealed together with the fecal sample disposed therein, the vial provides a liquid tight environment adequate for preservation of the metabolite profile during transport (Shimada; para [33]; In order to impart the airtight function to the feces sampling stick having the gripping part as a cap member, it is possible to provide a screw part at the base end of the stick part of the feces sampling stick and install the feces sampling stick in an airtight condition by screwing and inserting the feces sampling stick in the inner peripheral surface of the opening part of the container body).
1 The limitation is directed to the function and/or the manner of operating the vial, all the structural limitations of the claim has been disclosed by Shimada and the vial of Shimada is capable of “transport by a common carrier”. As such, it is deemed that the claimed vial is not differentiated from the vial of Shimada (see MPEP §2114).
Regarding claim 2, Shimada teaches the vial as in claim 1, configured for receiving a swipe adapted for retention of the fecal sample (Shimada; Fig. 1; para [52]; a stick part 7 of the feces sampling stick 2 is inserted in a bottomed tubular container body 20 in an upright state via a tubular guide part 13 of a fitting body 10). The limitation is directed to the function and/or the manner of operating the vial, all the structural limitations of the claim has been disclosed by Shimada and the vial of Shimada is capable of “receiving a swipe adapted for retention of the fecal sample”. As such, it is deemed that the claimed vial is not differentiated from the vial of Shimada (see MPEP §2114).
Regarding claim 3, Shimada teaches the vial as in claim 1, wherein the metabolite profile is associated with at least one of a type of pathogen, a type of bacteria, a type of virus, a gastrointestinal infection, an inflammatory bowel disease, a parasite, a digestive disorder, a gut microbiome, and cancer. The limitation “the metabolite profile” is not a positively recited limitation, because the limitation is intended use of the vial. As such, it is deemed that the claimed vial is not differentiated from the vial of Shimada (see MPEP §2114). Thus, the limitation is not required as the “metabolite profile” is not required because the limitation is not positively recited.
Regarding claim 4, Shimada teaches the vial as in claim 1, wherein the preservative comprises at least one of water, ethanol, methanol, sodium acetate, formalin, polyvinyl alcohol (PVA), a Cary-Blair medium and sodium thioglycolate (Shimada; para [40]; an aqueous medium such as deionized water, distilled water).
Regarding claim 5, Shimada teaches the vial as in claim 1, wherein at least one of the body and the cap comprises at least one of dimples, detents, ridges, splines, threads, a snap, an interlock and at least one sealing feature (Shimada; Fig. 1; para [33]; In order to impart the airtight function to the feces sampling stick having the gripping part as a cap member, it is possible to provide a screw part at the base end of the stick part of the feces sampling stick and install the feces sampling stick in an airtight condition by screwing and inserting the feces sampling stick in the inner peripheral surface of the opening part of the container body).
Regarding claim 7, Shimada teaches the vial as in claim 1, wherein the body comprises a cover adapted for retention of the preservative until installation of the cap, thereupon causing a free-flow of the preservative between the cap and the body (Shimada; Fig. 1; para [42]; The fitting body to be fitted to the inner part of the container body preferably has a tubular guide part capable of liquid-tightly shielding the inside of the container body)
Regarding claim 8, Shimada teaches the vial as in claim 7, wherein the cap comprises an engagement feature for causing breakage of the cover (Shimada; para [42, 43]; the fitting body include a fitting body composed of a single fitting block provided with the first leveling hole and the second leveling hole on the tubular guide part…the second leveling hole may be provided with a thin-film sealing film).
Regarding claim 9, Shimada teaches the vial as in claim 1, further comprising a plunger configured for compressing a swipe containing the fecal sample upon centrifugation of the vial (Shimada; para [52]; a stick part 7 of the feces sampling stick 2). The examiner notes that the stick part interpreted as the plunger compresses/pushes the swipe interpreted as the feces sampling part through the first and second leveling hole of the fitting body. The limitation is directed to the function and/or the manner of operating the plunger, all the structural limitations of the claim has been disclosed by Shimada and the plunger of Shimada is capable of “compressing a swipe containing the fecal sample upon centrifugation of the vial”. As such, it is deemed that the claimed apparatus is not differentiated from the plunger of Shimada (see MPEP §2114).
Regarding claim 10, Shimada teaches the vial as in claim 1, wherein the body is configured for receiving a swipe containing the fecal sample (Shimada; para [52]; a stick part 7 of the feces sampling stick 2 is inserted in a bottomed tubular container body 20).
Regarding claim 11, Shimada teaches the vial as in claim 1, wherein the cap comprises a chamber configured for receiving a swipe containing the fecal sample (Shimada; Fig. 2; para [52]; feces sample B). The “swipe” is not a positively recited limitation of the vial, thus the limitation is not required. The cap comprises the chamber which holds the feces sample as seen in Fig. 2
Regarding claim 12, Shimada teaches the vial as in claim 1, wherein the body is configured for evaluation by analytical equipment of a laboratory (Shimada; para [41]; As to the analysis system, there is no restriction as long as it is a system that can analyze the component in the feces sample dissolved in the aqueous medium, and examples thereof in case the component in the feces sample is hemoglobin include a hemoglobin analyzer).
Regarding claim 13, Shimada teaches a kit for collecting a fecal sample, the kit comprising:
a vial adapted for preservation of a metabolite profile of a fecal sample during transport thereof (Shimada; Abstract; para [7]; feces sampling container…provide a feces sampling container to increase a storage stability of a component, such as hemoglobin, in a feces sample and to measure the component in a feces sample with a small amount of feces collected), the vial comprising: a body comprising a volume of preservative (Shimada; Fig. 1; para [40, 53]; the aqueous medium for dissolving a component in a feces sample…a feces sampling container comprising a pierce part 14 for introducing an aqueous medium for dissolving a component in a feces sample in a top part of a fitting body 10); and, a cap configured to engage with the body and to seal sample fluid comprising a mixture of the preservative and fecal sample within the vial during transport by a common carrier (Shimada; Fig. 1; para [33]; In order to impart the airtight function to the feces sampling stick having the gripping part as a cap member, it is possible to provide a screw part at the base end of the stick part of the feces sampling stick and install the feces sampling stick in an airtight condition by screwing and inserting the feces sampling stick in the inner peripheral surface of the opening part of the container body); and,
a swipe for collection of the fecal sample, the swipe configured for being loaded into the vial (Shimada; para [52]; feces is collected by sticking a feces sampling part 5 in a feces or rubbing the surface of the feces with a feces sampling part 5),
wherein once the body and the cap have been sealed together with the fecal sample disposed therein, the vial provides a liquid tight environment adequate for preservation of the metabolite profile during transport (Shimada; para [33]; In order to impart the airtight function to the feces sampling stick having the gripping part as a cap member, it is possible to provide a screw part at the base end of the stick part of the feces sampling stick and install the feces sampling stick in an airtight condition by screwing and inserting the feces sampling stick in the inner peripheral surface of the opening part of the container body).
Regarding claim 14, Shimada teaches the kit as in claim 13, further comprising at least one of hygienic accessories (Shimada; para [52]; a gripping part 3 of the feces sampling stick 2 with hand; the examiner notes that the gripping part is interpreted as a hygienic accessory because the user is capable of avoiding direct contact) and a shipping container (Shimada; para [52]; tubular container body).
Regarding claim 15, Shimada teaches the kit as in claim 13, wherein the swipe is substantially lint-free (Shimada; para [34]; the feces sampling stick include low-density polyethylene and ABS resin).
Claim(s) 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kirkpatrick et al (US 20220032295 A1; hereinafter “Kirkpatrick”; already of record).
Regarding claim 16, Kirkpatrick teaches a system for ascertaining metabolite profile information from a fecal sample (Kirkpatrick; Abstract), the system comprising:
sample handling equipment for analytical preparation of the fecal sample (Kirkpatrick; Fig. 2; para [130]; prep pod device 200), the fecal sample provided in a vial configured for transport by a common carrier (Kirkpatrick; Fig. 2; para [130]; the analysis device may include, but not limited to, a lateral flow assay cartridge 205; examiner interprets the common carrier as the cartridge), the vial comprising a body (Kirkpatrick; Fig. 1; para [124]; swab chamber 100) and a cap engaged with the body and sealing sample fluid (Kirkpatrick; Fig. 1; para [129]; cap 130) comprising a mixture of preservative and a swipe with the fecal sample therein (Kirkpatrick; para [8]; sample extraction device for extracting a biological analyte from a biological sampling device, such as a swab…The sample extraction device may further include a mechanism configured to apply compressive mechanical and/or piercing force on the reagent storage vessel to release a reagent contained in the reagent storage vessel into the sample chamber) and providing a liquid tight environment adequate for preservation of the metabolite profile during transport (Kirkpatrick; para [181]; In some embodiments the metering cap 2300 may include a slot 2305, 2320, 2345, and 2355 for an external O-ring to ensure a tight seal when the prep pod and metering cap assembly is inverted and inserted into the cartridge sample well. This O-ring seal prevents undesirable leaking of the liquid sample off the test strip or into other unintended regions of the cartridge);
analysis equipment suited for analyzing the prepared fecal sample (Kirkpatrick; para [234]; analytical methods, diagnostic testing methods, or other methods that may be used with samples extracted from the sample preparation device); and
a processor comprising machine executable instructions stored on non-transitory machine readable media, the instructions for at least one of operating the sample handling equipment, operating the analysis equipment, interpreting output of the analysis equipment and providing a report containing the metabolite profile information (Kirkpatrick; para [136, 234]; software application or app on the smartphone 515 may continuously capture video or images of the lateral flow assay cartridge result window or analyte detection zone to determine if a liquid sample has been added to the cartridge 505 for automated timing of the assay duration and automated timing of when to initiate signal acquisition…metabolic analysis). The examiner notes that the device listed by Kirkpatrick comprises a processor/controller to operate, thus the limitation is met as the analysis equipment performs metabolic analysis.
Regarding claim 17, Nagao Kirkpatrick ka teaches the system as in claim 16, wherein the analysis equipment is configured for at least one of gas chromatography-mass spectrometry (GC-MS); liquid chromatography-mass spectrometry (LC-MS); nuclear magnetic resonance (NMR) spectroscopy; and fourier transform infrared (FTIR) spectroscopy (Kirkpatrick; para [234]; analytical methods, diagnostic testing methods, or other methods that may be used with samples extracted from the sample preparation device…GC-MS).
Regarding claim 18, Kirkpatrick teaches the system as in claim 16, wherein the instructions are configured to adjust the metabolite profile information according to a data set comprising information about at least one of the swipe and the sample fluid (Kirkpatrick; para [268]; the sample prep device allows a multistep process for extraction of DNA or other analytes from the fecal matter including enzymatic digestion with various reconstituted enzymes, chemical lysis, neutralization, emulsification using surfactants such as AOT, and flocculation of certain components of the feces. Applications for analysis of fecal samples could include microbiome sequencing to provide actionable information to users about their gut microbial species, thereby enabling dietary changes or other interventions that can improve health).
Regarding claim 19, Kirkpatrick teaches the system as in claim 16, wherein the instructions perform the interpreting by implementation of artificial intelligence (Al) (Kirkpatrick; para [234]; In some embodiments analysis of the sample may include use of artificial intelligence).
Regarding claim 20, Kirkpatrick teaches the system as in claim 16, wherein the report contains metabolite profile information containing at least one of molecular identity information, concentration information, and pathology information (Kirkpatrick; para [174]; the detection zone of the strip may be a nitrocellulose membrane that has immobilized affinity reagents that give a signal that indicates the presence or absence of one or more analytes, and in some embodiments the signal can give quantitative information about the concentration of the analyte in the sample).
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Shimada in view of Gao (US 20200056965 A1; hereinafter “Gao”; already of record).
Regarding claim 6, Shimada teaches the vial as in claim 5, with the sealing feature.
Shimada does not teach wherein the sealing feature comprises at least one of a sealing ring and a separate washer.
However, Gao teaches an analogous art of a device for collecting and extracting fecal samples (Gao; Abstract) comprising a vial (Gao; Fig. 2; para [21]; a bottom container 2) and a cap (Gao; Fig. 2; para [21]; top cap 4 and middle cap 3; examiner interprets the cap to comprise the top cap and bottom cap) comprising a sealing feature (Gao; para [13]; the middle cap comprises a bottom part having an inner thread able to sealably engage an external thread provided on the top part of the bottom container), wherein the sealing feature comprises at least one a sealing ring and a separate washer (Gao; para [32]; a annular seal (7′) made of elastic materials, e.g. a rubber O-ring). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the sealing feature of Shimada to comprise the at least one sealing ring as taught by Gao, because Gao teaches that O-ring aids in sealing the middle cap and the bottom container (Gao; para [32]).
Response to Arguments
Applicant’s arguments filed, 2/9/2026, have been fully considered. The arguments are not found to be persuasive, and the non-persuasive arguments are addressed below.
In the Applicant’s arguments, on page 2-3, the Applicant argues that Shimada fails to teach “preservation of a metabolite profile during transport”. The examiner respectfully disagrees. a vial adapted for preservation of a metabolite profile of a fecal sample during transport thereof (Shimada; Abstract; para [7]; feces sampling container…provide a feces sampling container to increase a storage stability of a component, such as hemoglobin, in a feces sample and to measure the component in a feces sample with a small amount of feces collected). Further, Applicant argues that Shimada fails to teach wherein once the body and the cap have been sealed together with the fecal sample disposed therein, the vial provides a liquid tight environment adequate for preservation of the metabolite profile during transport. The examiner respectfully disagrees. Shimada teaches in order to impart the airtight function to the feces sampling stick having the gripping part as a cap member, it is possible to provide a screw part at the base end of the stick part of the feces sampling stick and install the feces sampling stick in an airtight condition by screwing and inserting the feces sampling stick in the inner peripheral surface of the opening part of the container body (para [33]).
In the Applicant’s arguments, on page 4, the Applicant argues that Kirkpatrick fails to teach the vial. Specifically, the prep pod device as discussed is not equivalent and substantially different from the claim. The examiner respectfully disagrees. The device taught by Kirkpatrick does provide structural limitations that does not distinguish the device of Kirkpatrick from the claimed invention. Specifically, Kirkpatrick teaches all structural and functional limitations as cited above. Examiner notes that the broadest reasonable interpretation of a “vial” is interpreted as a container which is capable of holding something, all of which is disclosed by Kirkpatrick.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/A.Q.L./Examiner, Art Unit 1796 /DUANE SMITH/ Supervisory Patent Examiner, Art Unit 1759