Office Action 4: Notice of Allowance (2025-03-07)

CLAIMS:
CLAIMS

This listing of claims will replace all prior versions, and listings, of claims in the application.

LISTING OF CLAIMS:

Office Action dated: August 30, 2024 Response dated: November 26, 2024

1\. (Previously presented) A breath sampler for collecting a breath sample from a patient, the breath sampler comprising:a non-rebreather part comprising:
a sample inlet;
a one-way outlet valve arranged to allow air to exit the non-rebreather part, the one- way outlet valve and the sample inlet defining a first portion of an internal breath flow pathway therebetween; and
an air inlet comprising a plurality of slits in a wall of the breath sampler and arranged to be closed by a one-way inlet valve arranged to allow air to enter the non- rebreather part, the air inlet being in fluid communication with the first portion of the internal breath flow pathway; and
a sample delivery part in fluid communication with the non-rebreather part at an upstream end via the one-way outlet valve, the sample delivery part defining a second portion of the internal breath flow pathway, the sample delivery part comprising:
an air diverter, in the sample delivery part, arranged to divide the sample delivery part into an upstream portion and a downstream portion;
a sample outlet in the upstream portion;
a return inlet in the downstream portion and in fluid communication with an exhaust; and
a sample collection chamber connector configured to form a seal with an opening of a sample collection chamber, the connector defining a perimeter, the sample outlet and the return inlet being disposed within the perimeter;
wherein the breath sampler further comprises the sample collection chamber coupled to the sample collection chamber connector, the sample collection chamber comprising a liquid capture interface,

wherein the breath sampler is configured so that, during operation, the breath sample from the patient passes through the non-rebreather part, is delivered via the sample delivery part to the sample outlet into the sample collection chamber, passes through the liquid capture interface in the sample collection chamber, which captures at least one of chemical markers and biological markers from the breath sample, the breath then re-enters the sample delivery part from the sample collection chamber via the return inlet, and escapes the breath sampler via the exhaust.

2\. (Previously presented) The breath sampler according to claim 1, further comprising a sample delivery tube coupled to the sample outlet for delivering the breath sample to the liquid capture interface, and wherein the sampledelivery tube is removably connected to the sample outlet.

3\. (Previously presented) The breath sampler according to claim 2, further comprising a diffuser coupled to the sample delivery tube, the diffuser comprising an inlet and a network of channels to divide the breath sample from the inlet into a plurality of streams.

4\. (Previously presented) The breath sampler according to claim 1, wherein the air diverter comprises a wall extending in a plane that is transverse to the longitudinal axis of the sample delivery part.

5\. (Previously presented) The breath sampler according to claim 1, further comprising a volumetric breath quantifier configured to measure a volume of breath delivered to the sample outlet.

6\. (Previously presented) The breath sampler according to claim 5, wherein the volumetric breath quantifier is configured to separate the breath sample into at least two sub-samples.

7\. (Previously presented) The breath sampler according to claim 6, wherein the volumetric breath quantifier further comprises a closure member configured to selectively close the sample outlet to prevent a first sub-sample being delivered to the sample collection chamber.

8\. (Previously presented) The breath sampler according to claim 7, wherein the volumetric breath quantifier comprises a Geneva gear configured to open the closure member when a predetermined volume of breath has entered the volumetric breath quantifier.

9\. (Previously presented) The breath sampler according to claim 8, wherein the volumetric breath quantifier is positioned downstream of the outlet valve and comprises:a turnstile rotatably mounted within the breath flow pathway and comprising at least one fin configured to be rotatably displaced by a defined breath volume;
a geared coupling between the turnstile and the Geneva gear;
wherein the turnstile is configured to move the Geneva gear from a first position to a second position, and
wherein movement of the Geneva gear from the first position to the second position is configured to open the closure member to allow a second sub-sample to be delivered to the sample collection chamber.

10\. (Previously presented) The breath sampler according to claim 1, further comprising a plurality of selectively connectable modules.

11\. (Previously presented) The breath sampler according to claim 10, wherein:a first module comprises the non-rebreather part, the one-way outlet valve and the one-way air inlet; and
a second module comprises the sample delivery part and the sample collection chamber connector.

12\. (Cancelled)

13\. (Previously presented) The breath sampler according to claim 1, further comprising a delivery port in fluid communication with the non-rebreather part, configured for connection to a nebuliser.

14\. (Previously presented) The breath sampler according to claim 1, wherein the sample collection chamber further comprises an integrated testing module.

15\. (Previously presented) The breath sampler according to claim 14, wherein the integrated testingmodule is a lab-on-chip device.

16\. (Previously presented) The breath sampler according to claim 14, wherein the integrated testingmodule comprises a PCR unit.

17\. (Previously presented) The breath sampler according to claim 1, wherein at least one of the non-rebreather part and the sampledelivery part comprises a sensor configured to measure additional biomarkers including one or more of: nucleic acids, cytokines, chemokines, C- reactive protein, hosts and pathogens.

18\. (Previously presented) The breath sampler according to claim 1, wherein the exhaust comprises a filter or mesh.

19\. (Previously presented) The breath sampler according to claim 1, ftiurther comprising a breath sampler cap configured to removably attach to a distal end of the breath sampler, the distal end of the breath sampler being an end opposite to an end comprising the sample inlet.

20\. (Previously presented) The breath sampler according to claim 19, wherein the sampler cap is arranged to cover the exhaust.

21\. (Previously presented) The breath sampler according to claim 19, wherein the sampler cap comprises connection means corresponding to the sample collection chamber.

OFFICE ACTION:
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 .
Allowable Subject Matter
Claims 1-11 and 13-21 are allowed.
The following is an examiner’s statement of reasons for allowance: The closest prior art of record, Pan (US 20040077093 A1) and Dr Moschos (US 20210093226 A1), fails to disclose “a one-way outlet valve arranged to allow air to exit the non-rebreather part, the one- way outlet valve and the sample inlet defining a first portion of an internal breath flow pathway therebetween; and an air inlet comprising a plurality of slits in a wall of the breath sampler and arranged to be closed by a one-way inlet valve arranged to allow air to enter the non- rebreather part” and “wherein the breath sampler is configured so that, during operation, the breath sample from the patient passes through the non-rebreather part, is delivered via the sample delivery part to the sample outlet into the sample collection chamber, passes through the liquid capture interface in the sample collection chamber, which captures at least one of chemical markers and biological markers from the breath sample, the breath then re-enters the sample delivery part from the sample collection chamber via the return inlet, and escapes the breath sampler via the exhaust”.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee.  Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion

APPLICANT REBUTTAL: REMARKS
Favorable reconsideration of this application is respectfully requested in view of the following remarks.
Rej
ection under 35 U.S.C.
@
Claims 1, 10, and 14 stand rejected under 35 U.S.C. § 103 as allegedly being unpatentable over U.S. Patent Application Publication No. 2004/0077093 to Pan in view of U.S. Patent Application Publication No. 2014/0276169 to Chua.
claim 17 stands rejected under 35 U.S.C. § 103 as allegedly beingunpatentable over Pan in view of Chua, Eichler, and U.S. Patent Application Publication No. 2015/0072889 to Lui et al.; claim 18 stands rejected under 35 U.S.C. § 103 as allegedly being unpatentable over Pan in view of Chua and U.S. Patent No. 5,465,728 to Phillips; and claims 19- 21 stand rejected under 35 U.S.C. § 103 as allegedly being unpatentable over Pan in view of Chua and U.S. Patent Application Publication No. 2004/0138577 to Kline.
The rejections are respectfully traversed for at least the following reasons.
The Official Action relies on Pan as teaching most of the features of claim 1, except for an air inlet comprising a plurality of slits, which is considered to be derivable from Chua (see Official Action, point 2, pages 7-8).
Pan relates to an apparatus for detecting bacteria in a subject. Fig. 2 depicts a breath sampler (101), which has a tube (107) that extends between an open mouthpiece end (111) and an open intake end (113). A check valve (115) arranged near the intake end restricts flow through the tube to a direction toward the mouthpiece end and blocks flow out ofthe intake end. A sample collection branch (109) connected to a sample container (117) branches from the tube between the intake end and the mouthpiece end. A second check valve (123) is disposed in the sample collection branch. Further, the container has a vent (119) with yet another check valve (121) that permits the flow of air out of the container upon exhalation. This arrangement is structurally different than that of the breath sampler of claim 1.
To start, the Official Action has taken the check valve (115) as corresponding to the one- way outlet valve of the non-rebreather part
and
to the air inlet comprising a slit in a wall of the breath sampler (See Official Action, point 2, page 7, "a one-way outlet valve (115)...an air inlet comprising a slit in a wall of the breath sample ("slit," para [0063])). This is incompatible with the language of claim 1 and thus in error. Specifically, claim I recites that the non-rebreather part comprises a one-way outlet valve arranged to allow air to exit the non-rebreather part and an air inlet comprising a plurality of slits in a wall of the breath sampler. As mentioned above, Pan's check valve (115) explicitly "restricts flow through the tube at the intake end to a direction toward the mouthpiece end Ill and blocks flow out of the intake end" (Pan at para. [0063]). In this sense, check valve (115) permits air to be taken in through the intake end but does not permit air to exit the tube (non-rebreather part). Check valve (115) thus does not and cannot reasonably be considered to correspond to the recited one-way outlet valve.
Check valve (115) also cannot fully correspond with the recited air inlet since "Pan does not expressly disclose the air inlet comprising a plurality of slits," as already acknowledged by the Official Action (see Official Action, point 2, page 8). In addition to this general deficiency, it is further respectfully pointed out the claim I recites an air inlet comprising a plurality of slits
in
a
wall of
the
breath sampler.
Attention is respectfully drawn to the fact that the 'slit' mentioned in Pan is in the check valve (115), not in the wall of the tube (breath sampler) itself (Pan at para. [0063], which provides "check valve 115 may be of any suitable construction, such as a generally
cone-shaped diaphragm having a slit in its small end"). That the slit is not comprised in the wall of the tube (breath sampler) is further apparent from at least Fig. 3 of Pan. Compare Fig. 3 (intake end 113) of Pan with Fig. 6E (inlet 140), for example, of the present application.
Similarly, Chua, which relates to a divided nasal cannula, merely teaches another one-way valve 50; the valve generally comprises a sealed opening which is provided with at least one slit, and possibly a plurality of slits, which allows the valve to open when there is a suitable pressure differential on opposed sides of the valve (see Chua at para. [0033]). Chua suffers from the same deficiencies as Pan in that it does not teach or reasonably suggest an air inlet comprising a plurality of slits
in a wall of the breath sample
r
.
Accordingly, even if the ordinarily skilled artisan had consulted Chua if and when seeking to modify Pan's breath sampler, he/she would still not have arrived at the breath sampler of claim 1.
Turning back to Pan, the Official Action further takes "the structure that branches away from 107 via 109", i.e., the sample collection branch (109), as corresponding to the recited sample delivery part. However, this is structurally inconsistent with claim 1, which recites that the sample delivery part is in fluid communication with the non-breather part (tube 107) via the one-way outlet valve. As is clearly shown in Fig. 2 of Pan, check valve (115), which is arranged near the intake end (113) of the tube, cannot reasonably be considered to place the sample delivery part (109) branching away from (107) in fluid communication with the non-breather part (107).
the orientationof check valve (123) permits the breath sample to flow outwardly from the mouthpiece end (111) through the tube (107), sample collection branch (109) and to block air flow through the sample collection branch, container and tube toward the mouthpiece end (Pan at para. [0064]). Since the check valve (123) blocks air from flowing back through the sample collection branch (109), Pan lacks a sample outlet in the upstream portion.
Further, the Official Action takes the check valve (121) in vent (119) as corresponding to the recited return inlet in the downstream portion of the sample delivery part. This is also problematic since, like the other check valves, air is only permitted to flow in a single direction
(Pan at para. [0064], which provides that "check valve 121 in the vent 119 permits flow of air out of the container 117 upon exhalation, but when the subject is not providing air pressure, closes the container vent to the influx of ambient air and to outflow of liquid L"). Thus, check valve (121) is not a return inlet since it is not possible for air (the breath) to re-enter the sample delivery part therefrom.
In view of the foregoing structural inconsistencies between Pan and claim 1, it further logically follows, that Pan further fails to teach or render obvious the path of the breath sample therethrough; more specifically, Pan fails to teach or reasonably suggest that the breath sample passes through the non-rebreather part, is delivered via the sample delivery part to the sample outlet into the sample collection chamber, passes through the liquid capture interface in the sample collection chamber, then re-enters the sample delivery part from the sample collection chamber via the return inlet, and escapes the breath sampler via the exhaust.
For the sake of completeness, it is recognized that Dr Moschos, Nashed, Dompeling, King- Smith, Ahmad, Akouka, Eichler, Meka, Ku, Lui, Phillips, and Kline were also cited by the Official Action but solely with respect to features set forth in dependent claims. Dr Moschos, Nashed, Dompeling, King-Smith, Ahmad, Akouka, Eichler, Meka, Ku, Lui, Phillips, and Kline each lack any disclosure or reasonable suggestion of at least a non-rebreather part with a one-way outlet valve and an air inlet comprising a plurality of slits in a wall of the breath sampler. Consequently, none of Dr Moschos, Nashed, Dompeling, King-Smith, Ahmad, Akouka, Eichler, Meka, Ku, Lui, Phillips, and Kline can be applied to remedy the aforementioned deficiencies of Pan and Chua.
For at least the reasons discussed herein, it is respectfully submitted that the disclosures in Pan, Chua, Dr Moschos, Nashed, Dompeling, King-Smith, Ahmad, Akouka, Eichler, Meka, Ku, Lui, Phillips, and Kline, whether taken individually or in combination, would not have rendered the breath sampler set forth in claim 1 obvious.
The dependent claims are patentable over the cited references at least by virtue of their dependence from independent claim 1. A detailed discussion of the additional distinguishing features recited in the dependent claims is thus not set forth at this time. Applicant reserves the right to present such arguments later during prosecution or appeal.
Reconsideration and withdrawal of the rejection is respectfully requested.
Early and favorable action with respect to this application is respectfully requested. In view of the above amendments and remarks, it is respectfully submitted that all of the claims now pending in the instant application should be allowable, and reconsideration thereof is respectfully requested.
Should any questions arise in connection with this application or should the Examiner believe that a telephone conference with the undersigned would be helpful in resolving any remaining issues pertaining to this application, the undersigned respectfully requests to be contacted at the number or email indicated below.
Respectfully submitted,


CITED REFERENCE SUMMARIES: Ref US20040077093A1: Claims:
1. A method for detecting in the gastrointestinal tract of a subject the presence of a bacteria which when present in the gastrointestinal tract of the subject is associated with the catalytic degradation of urea to ammonia and carbon dioxide, the method comprising: 
(a) delivering a source of urea to the gastrointestinal tract of the subject,  (b) obtaining a fluid sample from the subject after the delivery of the urea source,  (c) combining the fluid sample with an aqueous solution,  (d) contacting the aqueous solution with a sensor after the aqueous solution has been combined with the fluid sample, the sensor comprising a porous hydrophobic polymer having a dye embedded within the pores but not on the exposed surface thereof, the dye being capable of being deprotonated and undergoing a color change in the presence of ammonia, the pores being permeable to ammonia gas derived from the aqueous solution but impermeable to the aqueous solution whereby ammonia gas derived from the aqueous solution can permeate the pores and deprotonate the dye to effect a color change, and  (e) detecting a color change in the sensor after the sensor is contacted with the fluid sample.
2. The method of claim 1 wherein the bacteria causes a gastrointestinal associated disorder in the subject, the gastrointestinal associated disorder being selected from the group consisting of gastritis, peptic ulceration, gastric cancer, non-ulcer dyspesia, duodenal ulcers, gastric ulcers, duodenitis, gastric non-Hodgkin's lumphomas, intestinal metaplasia, adenocarcinoma, and esophagitis.
3. The method of claim 1 wherein the bacteria is a Helicobacter.
4. The method of claim 1 wherein the bacteria is Helicobacter pylori.
5. The method of claim 1 wherein the fluid sample is selected from the group consisting of a breath sample, a saliva sample, a perspiration vapor sample and a gastric reflux sample.
6. The method of claim 1 wherein the fluid sample is a breath sample.
7. The method of claim 6 wherein the breath sample is an exhaled sample or multiple breath samples.
8. The method of claim 1 wherein the aqueous solution further comprises sodium hydroxide.
9. The method of claim 1 wherein a droplet of water placed on the surface of the hydrophobic polymer has a contact angle of not less than about 100 degrees.
10. The method of claim 1 wherein the polymer has an average pore size of less than about 9 microns.
11. The method of claim 10 wherein the polymer has an average pore size of about 1.0 microns to about 2.5 microns.
12. The method of claim 1 wherein the polymer is selected from the group consisting of polytetrafluoroethylene, polyvinylidene difluoride, acrylic-based polymers, ethylene propylene polymers, polycarbonate, polyproylene, polyvanilidine chloride, dimethyl polysiloxane.
13. The method of claim 1 wherein the polymer comprises polyvinylidene difluoride.
14. The method of claim 1 wherein the dye is selected from the group consisting of bromophenol blue, bromothymol, phenol red, methyl orange, methyl yellow, 2,4-dinitrophenol, 2,6-dinitrophenol, and cresol red.
15. The method of claim 1 wherein the dye is bromophenol blue.
16. The method of claim 1 wherein the sensor changes color within about 5 to about 60 seconds after the porous polymer is permeated with the ammonia gas.
17. The method of claim 1 wherein the subject is administered a mouth wash comprising an antibacterial agent prior to collection of the breath sample to reduce the number of bacteria present in the subject's mouth.
18. The method of claim 1 wherein the concentration of ammonia gas is determined by measuring the color change of the dye with an optical reader.
19. The method of claim 1 wherein the sensor is in the form of a membrane.
20. The method of claim 1 wherein the sensor is in the form of particulate matter.
21. A method to detect the presence of a bacteria in the gastrointestinal tract of a subject, which when present in the gastrointestinal tract of the subject is associated with the catalytic degradation of urea to ammonia and carbon dioxide, the method comprising: 
(a) delivering a source of urea to the gastrointestinal tract of the subject,  (b) obtaining a liquid sample from the subject after the delivery of the urea source,  (c) contacting the liquid sample or a derivative thereof with a sensor, the sensor comprising a hydrophobic polymeric material and a dye associated with the polymeric material, the dye having the capacity to become deprotonated and undergo a color change in the presence of ammonia,  (d) controlling the contact conditions such that the sensor responds to the presence of ammonia in the fluid sample but not to the pH of the fluid sample by undergoing an optically discernible color change, and  (e) optically detecting a color change in the sensor after the sensor is contacted with the fluid sample.
22. The method of claim 21 wherein the liquid sample is selected from the group consisting of a saliva sample and a tear sample.
23. A method to detect the presence of a bacteria in the gastrointestinal tract of a subject, which when present in the gastrointestinal tract of the subject is associated with the catalytic degradation of urea to ammonia and carbon dioxide, the method comprising: 
(a) delivering a source of urea to the gastrointestinal tract of the subject,  (b) inducing the subject to exhale a breath sample into a container, the container comprising an inlet, a vent, and a sensor, and being adapted to restrict the flow of gas out of the inlet, the sensor comprising a hydrophobic polymeric material and a dye associated with the polymeric material, the dye having the capacity to become deprotonated and undergo a color change in the presence of ammonia,  (d) controlling the contact conditions such that the sensor responds to the presence of ammonia in the breath sample but not to the pH of the breath or any liquid in the container by undergoing an optically discernible color change, and  (e) optically detecting a color change in the sensor after the subject exhales into the container.
24. The method of claim 23 wherein a droplet of water placed on the surface of the hydrophobic polymer has a contact angle of not less than about 100 degrees.
25. The method of claim 23 wherein the polymer has an average pore size of less than about 9 microns.
26. The method of claim 23 wherein the polymer has an average pore size of about 1.0 microns to about 2.5 microns.
27. The method of claim 23 wherein the polymer is selected from the group consisting of polytetrafluoroethylene, polyvinylidene difluoride, acrylic-based polymers, ethylene propylene polymers, polycarbonate, polyproylene, polyvanilidine chloride, dimethyl polysiloxane.
28. The method of claim 23 wherein the polymer comprises polyvinylidene difluoride.
29. The method of claim 23 wherein the dye is selected from the group consisting of bromophenol blue, bromothymol, phenol red, methyl orange, methyl yellow, 2,4-dinitrophenol, 2,6-dinitrophenol, and cresol red.
30. The method of claim 23 wherein the dye is bromophenol blue.
31. A breath sampler for use in detecting the presence of H. pylori in the gastrointestinal tract, the breath sampler comprising a breath handler and a detection unit including a sensor capable of reacting to the presence of an indicator in the breath sample of H. pylori in the gastrointestinal tract, the breath handler being adapted to route air through the breath sampler upon inhalation by the subject to the subject while substantially blocking flow of air through the detection unit to the subject, and being adapted upon exhalation of the subject to route exhaled air through the breath handler to the detection unit for detection of H. pylori in the gastrointestinal tract.
32. A breath sampler as set forth in claim 31 wherein air flow through the detection unit is substantially blocked except upon exhalation by the subject through the breath sampler.
33. A breath sampler as set forth in claim 32 wherein the detection unit is substantially isolated from ambient except upon exhalation by the subject through the breath sampler.
34. A breath sampler as set forth in claim 32 wherein the breath handler includes an air intake, a breath sample opening and a breath sample outlet, the detection unit being arranged to receive air from the breath handler by way of the breath sample outlet, the breath handler receiving ambient air through the air intake upon inhalation by a subject and directing air to the breath sample opening for inhalation by the subject, and blocking a path from the breath sample outlet to the breath sample opening, the breath handler directing exhaled air from the subject to the breath sample outlet and thence to the detection unit, and blocking a path from the breath sample opening to the air intake.
35. A breath sampler as set forth in claim 34 wherein the breath handler comprises a tube having the air intake at one end thereof and the breath sample opening at an opposite end thereof, and a collection branch in fluid communication with the tube and the detection unit and including the breath sample outlet.
36. A breath sampler as set forth in claim 35 wherein the breath handler further comprises a first valve located generally at the air intake end of the tube for permitting inhaled air to flow into the tube but blocking the breath sample from flowing out of the tube through the air intake, and a second valve located in the collection branch for permitting the breath sample to flow from the tube through the collection branch and into the detection unit and blocking flow of air from the detection unit through the collection branch into the tube.
37. A breath sampler as set forth in claim 36 wherein the detection unit includes a vent for exhausting excess exhaled air from the detection unit, and wherein the detection unit further comprises a third valve disposed for permitting exhaust of exhaled air under pressure through the vent from the detection unit and inhibiting the intake of ambient air through the vent from outside the detection unit.
38. A breath sampler as set forth in claim 37 wherein the first, second and third valves are one way valves biased to a closed position in the absence of an air pressure differential across the valves.
39. A breath sampler as set forth in claim 31 further comprising liquid in the detection unit, the breath handler being adapted to discharge the breath sample into the liquid.
40. A breath sampler as set forth in claim 31 wherein the detection unit includes a vent for exhausting excess gas from the detection unit, and the breath handler comprises a tube having an intake end including an air intake and a mouthpiece portion including a breath sample opening, the intake end being positioned to locate the air intake out of registration with the vent to inhibit inhalation of exhausted air from the detection unit.
41. A breath sampler as set forth in claim 40 wherein the breath handler is pivotally mounted in the detection unit.
42. A breath sampler as set forth in claim 31 wherein the breath handler comprises a tube having an intake end including an air intake and a mouthpiece portion including a breath sample opening, the mouthpiece portion being tapered toward the breath sample opening to facilitate reception into the back of the mouth near the throat.
43. A breath sampler as set forth in claim 31 wherein the detection unit comprises a collection receptacle and the sensor is mounted in the collection receptacle, the sensor being adapted to change color upon the detection of said indicator in the breath sample, and the collection receptacle being at least partially transparent to permit a line of sight to the sensor.
44. A breath sampler as set forth in claim 31 wherein the breath sample outlet is arranged relative to the detection unit for directing the breath sample against the sensor.
45. A breath sampler as set forth in claim 31 in combination with a reader arranged for reading the sensor of the detection unit and displaying a readout corresponding to the sensor indication, the reader having a self contained power source and being adapted for connection together with the breath handler and detection unit when used by the subject to obtain a breath sample.
46. The combination as set forth in claim 45 wherein the reader is formed with a handle for holding the reader, detection unit and breath handler as the breath sample is being obtained.
47. The combination as set forth in claim 46 further in combination with a supply of urea in the form of at least one of: a bottle of urea and at least one tablet of urea.
48. A breath sampler for use in detecting the presence of H. pylori in the gastrointestinal tract, the breath sampler comprising a breath handler for receiving a breath sample from a subject, and a detection unit operatively connected to the breath handler for receiving the breath sample from the breath handler, the detection unit comprising a collection receptacle, a sensor membrane disposed in the receptacle capable of reacting to the presence of ammonia in the breath sample indicating the presence of H. pylori in the gastrointestinal tract, and a liquid in the collection receptacle generally covering the membrane, the liquid being capable of capturing ammonia from the breath sample to retain it in proximity to the sensor membrane.
49. A breath sampler as set forth in claim 48 wherein the liquid is water.
50. A breath sampler as set forth in claim 48 wherein the collection receptacle includes a bottom wall, the sensor membrane being disposed on the bottom wall and covered by the liquid.
51. A breath sampler for use in detecting the presence of H. pylori in the gastrointestinal tract, the breath sampler comprising a breath handler for receiving a breath sample from a subject, the breath handler including a mouthpiece portion having a breath sample opening in a distal end thereof, the mouthpiece portion being shaped for reception in a subject's mouth to locate the breath sample opening proximate the throat, and a detection unit operatively connected to the breath handler for receiving the breath sample from the breath handler, the detection unit including a sensor for detecting an indicator present in the breath sample of H. pylori in the gastrointestinal tract.
52. A breath sampler as set forth in claim 51 wherein the mouthpiece portion tapers in at least one dimension toward the breath sample opening.
53. A breath sampler as set forth in claim 52 wherein the mouthpiece portion tapers in cross sectional width and height.
54. A breath sampler as set forth in claim 53 wherein the breath handler comprises a tube including the mouthpiece portion and breath sample opening, and a collection branch extending from the tube to the detection unit, the mouthpiece portion extending from the collection branch to the breath sample opening and having a length selected to extend to the back of the subject's mouth.
Ref US20210093226A1: Claims:
A kit of parts for an assembly into an exhaled breath condensate collection device, the kit comprising: a mouthpiece module comprising a breath passageway defined in the mouthpiece module providing fluid communication from a mouthpiece breath inlet port for receiving exhaled breath to a mouthpiece breath outlet port in use; a collection vessel for insertion into the assembly to cool the collection vessel in use, the collection vessel defining a chamber for collecting exhaled breath condensate in use, wherein the chamber is sealed and resealable and comprises a vessel breath inlet for admitting exhaled breath into the chamber, wherein the vessel breath inlet is sealed; the kit of parts being configured such that the collection vessel is: insertable into the assembly into a sample collection configuration in which the vessel breath inlet is unsealed and allows fluid communication with the mouthpiece breath outlet port of the mouthpiece module; and removable from the assembly in a sample containment configuration in which the chamber of the collection vessel is resealed; wherein one or more parts of the kit of parts separately or together provides a sealing mechanism which is configured and/or operable such that the collection vessel is caused to be resealed by the sealing mechanism into the sample containment configuration after sample collection before the collection vessel is fully removed from the assembly.
a mouthpiece module comprising a breath passageway defined in the mouthpiece module providing fluid communication from a mouthpiece breath inlet port for receiving exhaled breath to a mouthpiece breath outlet port in use;
a collection vessel for insertion into the assembly to cool the collection vessel in use, the collection vessel defining a chamber for collecting exhaled breath condensate in use, wherein the chamber is sealed and resealable and comprises a vessel breath inlet for admitting exhaled breath into the chamber, wherein the vessel breath inlet is sealed;
the kit of parts being configured such that the collection vessel is: insertable into the assembly into a sample collection configuration in which the vessel breath inlet is unsealed and allows fluid communication with the mouthpiece breath outlet port of the mouthpiece module; and removable from the assembly in a sample containment configuration in which the chamber of the collection vessel is resealed;
insertable into the assembly into a sample collection configuration in which the vessel breath inlet is unsealed and allows fluid communication with the mouthpiece breath outlet port of the mouthpiece module; and
removable from the assembly in a sample containment configuration in which the chamber of the collection vessel is resealed;
wherein one or more parts of the kit of parts separately or together provides a sealing mechanism which is configured and/or operable such that the collection vessel is caused to be resealed by the sealing mechanism into the sample containment configuration after sample collection before the collection vessel is fully removed from the assembly.
The kit of claim 1 , wherein one or more parts of the kit of parts is configured and/or operable such that the collection vessel is caused to be unsealed into the sample collection configuration on or following insertion of the collection vessel into the assembly.
The kit of claim 1 , wherein the mouthpiece module is configured such that the mouthpiece breath outlet port is moveable to cause the vessel breath inlet to become unsealed on or following insertion of the collection vessel into the assembly.
The kit of claim 1 , wherein the vessel breath inlet is sealed by a film seal and wherein the mouthpiece module is configured such that the mouthpiece breath outlet port is moveable to penetrate the film seal on coupling of the mouthpiece breath outlet port in fluid communication with the vessel breath inlet.
The kit of claim 1 , wherein the collection vessel further comprises a sealed vessel exhaust outlet to emit collected breath in use, wherein the vessel exhaust outlet is sealed, and wherein the mouthpiece module further comprises an exhaust passageway coupled to a mouthpiece exhaust inlet port to conduct exhausted breath away from the collection vessel in use, and wherein the mouthpiece exhaust inlet port is moveable to cause the vessel exhaust outlet to become unsealed on or following insertion of the collection vessel into the assembly.
The kit of claim 5 , wherein the vessel exhaust outlet is sealed by a film seal and wherein the mouthpiece exhaust inlet port is moveable to penetrate the film seal on coupling of the mouthpiece exhaust inlet port in fluid communication with the vessel exhaust outlet.
The kit of claim 1 , wherein the mouthpiece module is formed such that the mouthpiece breath outlet port and mouthpiece exhaust inlet port are rigidly coupled to one or more moveable components, and wherein the mouthpiece module is con
[Truncated to input limit]