Office Action 3: Non-Final Rejection (2024-08-30)
Rejection types: 103 - Obviousness

CLAIMS:
CLAIMS

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

LISTING OF CLAIMS:

Office Action dated June 12, 2024 Response dated August 12, 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 sample delivery 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 testing module is a lab-on-chip device.

16\. (Previously presented) The breath sampler according to claim 14, wherein the integrated testing module 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 sample delivery 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, further 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 .
Response to Amendment
Applicant's request for reconsideration of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn.
Response to Arguments
Applicant’s remarks with respect to the rejections of claims 1-11 and 13-21 under 35 U.S.C. 103 have been fully considered and are persuasive.  Therefore, the rejection has been withdrawn.  However, upon further consideration, a new ground(s) of rejection is made in view of Pan (US 20040077093 A1) in view of Chua (US 20140276169 A1).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA  35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.  The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph:
(A)	the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B)	the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C)	the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.  Such claim limitation(s) is/are: “air diverter … arranged to divide the sample delivery part …” in claim 1; “sample collection chamber connector configured to form a seal with an opening” in claim 1; “liquid capture interface … which captures at least one of chemical markers and biological markers from the breath sample” in claim 1; “air diverter … arranged to divide the sample delivery part into an upstream portion and a downstream portion” in claim 1; “a volumetric breath quantifier configured to measure a volume of breath” in claims 5-6; and “closure member configured to selectively close the sample outlet” in claim 7.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The sample collection chamber connector is defined as a push fit, screw fit or bayonet attachment (page 8 lines 31-34); the liquid capture interface is defined as a salt solution (e.g., a phosphate buffered salt solution), a culture medium (e.g. a tryptic soy broth) or water for injection (page 10 lines 9-13); The air diverter is defined, on page 13 lines 27-31 and page 15 lines 3-11, as a wall, a wall comprising a notch; wall configurations, a network of channels; the volumetric breath quantifier is defined as one or more rotatably mounted blades or sails (page 15 lines 29-33); and the closure member is defined as a binary valve (page 16 lines 4-6 and line 18).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph, applicant may:  (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA  35 U.S.C. 112, sixth paragraph.
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.
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.
Claims 1, 10, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Pan (US 20040077093 A1) in view of Chua (US 20140276169 A1).
Regarding claim 1, Pan discloses a breath sampler for collecting a breath sample from a patient (Abstract), the breath sampler comprising: a non-rebreather part (107) comprising: a sample inlet (111); a one-way outlet valve (115) arranged to allow air to exit the non-rebreather part (para [0063]), the one-way outlet valve and the sample inlet defining a first portion of an internal breath flow pathway therebetween (unlabeled, but as can be seen in Figs. 1-2); and an air inlet comprising a slit in a wall of the breath sampler (“slit,” para [0063]) and arranged to be closed by a one-way valve arranged to allow air to enter the non-rebreather part (para [0063]), the air inlet being in fluid communication with the first portion of the internal breath flow pathway (as can be seen in Figs. 1-2); and a sample delivery part (the structure that branches away from 107 via 109 shown in Figs. 1-2) in fluid communication with the non-rebreather part at an upstream end via the one-way outlet valve (the branch 109 is upstream of 115 as shown in Figs. 1-2), the sample delivery part defining a second portion of the internal breath flow pathway (unlabeled, but as can be seen in Figs. 1-2), the sample delivery part comprising: an air diverter (123, “conical walls” para. [0063-0064]), in the sample delivery part (as can be seen in Figs. 1-2), arranged to divide (Examiner’s Note: functional language, i.e., capable of) the sample delivery part into an upstream portion and a downstream portion (para [0064]); a sample outlet (109) in the upstream portion (as can be seen in Figs. 1-2); a return inlet (121) in the downstream portion (as can be seen in Figs. 1-2) and in fluid communication with an exhaust (119); and a sample collection chamber connector (117) configured to form a seal with an opening (opening of 105 as can be seen in Figs. 1-2) of a sample collection chamber (Examiner’s note: the space inside as denoted by reference numeral 105 being the “chamber”), the connector defining a perimeter (as can be seen in Figs. 1-2), the sample outlet and the return inlet being disposed within the perimeter (as can be seen in Figs. 1-2); wherein the breath sampler further comprises the sample collection chamber coupled to the sample collection chamber connector (as can be seen in Figs. 1-2), the sample collection chamber comprising a liquid capture interface (L) (Fig. 2) (para [0065]), wherein the breath sampler is configured so that, during operation, the breath sample from the patient passes through the non-rebreather part (para [0063]), is delivered via the sample delivery part to the sample outlet into the sample collection chamber (para [0064]), passes through the liquid capture interface in the sample collection chamber (para [0064]), which captures at least one chemical markers and biological markers from the breath sample (para [0065]), the breath then re-enters the sample delivery part from the sample collection chamber via the return inlet (para [0064]), and escapes the breath sampler via the exhaust (para [0064]). Pan does not expressly disclose the air inlet comprising a plurality of slits.
However, Chua discloses the air inlet (valve 50) comprising a plurality of slits (“plurality of slits”, para. [0033]).
It would have been obvious to a skilled artisan to modify Pan for air inlet comprising a plurality of slits, in view of the teachings of Chua, as such a modification is merely a substitution of the check-valve of Pan for the valve of Chua.
Regarding claim 10, Pan further discloses 10, the breath sampler according to claim 1, further comprising a plurality of selectively connectable modules (figs. 3 & 6, “snap together attachment”, para. [0070]).
Regarding claim 14, Pan further discloses the breath sampler according to claim 1, wherein the sample collection chamber further comprises an integrated testing module (227, para. [0068]).
Claims 2-3, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Pan in view of Chua, as applied to claim 1 above, and further in view of Dr Moschos (US 20210093226 A1).
Regarding claim 2, Pan further discloses the breath sampler according to claim 1, further comprising a sample delivery tube (109) coupled to the sample outlet for delivering the breath sample (para. [0064]) to the liquid capture interface ((L) (Fig. 2, para. [0065]). Pan does not expressly disclose wherein the sample delivery tube is removably connected to the sample outlet.
However, Dr Moschos discloses wherein the sample delivery tube is removably connected to the sample outlet (para. [0075], removable from the first inner component 121 of the mouthpiece inner component 120 for cleaning of the saliva trap formed therein).
It would have been obvious to a skilled artisan to modify Pan wherein the sample delivery tube is removably connected to the sample outlet, in view of the teachings of Dr Moschos, for the obvious advantage cleaning the saliva trap formed therein.
Regarding claim 3, Pan further discloses the breath sampler according to claim 2, further comprising a diffuser (125) coupled to the sample delivery tube, the diffuser comprising an inlet and a network of channels (126) to divide the breath sample from the inlet into a plurality of streams (para. [0065]).
Regarding claim 11, Pan further discloses the breath sampler according to claim 10, the non-rebreather part, the one-way outlet valve and the one-way air inlet (as seen in figure 1); and the sample delivery part (as seen in figure 1) (as seen in figures 5-6).  Pan does not expressly disclose a first module and a second module and the sample collection chamber connector.
However, Dr Moschos discloses a first module (paragraph [0074], first chamber 130 including mouthpiece breath inlet port 122 (with incorporated check valve of Pan) and mouthpiece breath outlet tube 134 (with incorporated check valve of Pan)); and a second module comprises the sample delivery part and the sample collection chamber connector (figure 8a, paragraphs [0082, 0087], collection vessel housing 200 having collection vessel 300 including vessel breath tube 330 (see also para. [0088-0089])).
It would have been obvious to the skilled artisan to modify Pan to comprise a first module and a second module wherein the first module comprises the non-rebreather, the one-way outlet valve and the one-way air inlet part and the second module comprises the sample delivery part and the sample collection chamber connector, in view of the teachings of Dr Moschos, for the obvious advantage of removing the collection vessel for centrifuging and emptying the collection vessel for analysis (Dr. Moschos para. [0089]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Pan in view of Chua, as applied to claim 1 above, and further in view of Nashed (US 10086166 B1).
Regarding claim 4, Pan further discloses the breath sampler according to claim 1. Pan does not expressly disclose wherein the air diverter comprises a wall extending in a plane that is transverse to the longitudinal axis of the sample delivery part.
However, Nashed discloses wherein the air diverter comprises a wall extending in a plane that is transverse to the longitudinal axis of the sample delivery part (figures 4-5, “transverse divider wall 24”). Nashed further discloses a valve disc 36 (figure 4) and a valve seat (col. 15 lines 45-48).
It would have been obvious to a skilled artisan to modify Pan wherein the air diverter comprises a wall extending in a plane that is transverse to the longitudinal axis of the sample delivery part, in view of the teachings of Nashed, as such a modification is merely a substitution of the conical walls of the valve 123 of Pan for the transverse divider wall of Nashed that has a valve seat and valve disc to provide a seal through which gas could not freely pass.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Pan in view of Chua, as applied to claim 1 above, and further in view of Dompeling (US 20100292601 A1).
Regarding claim 5, Pan further discloses the breath sampler according to claim 1. Pan does not disclose a volumetric breath quantifier configured to measure a volume of breath delivered to the sample outlet.
However, Dompeling discloses a volumetric breath quantifier (para. [0037], flow meter 14) configured to measure a volume of breath delivered to the sample outlet (para. [0037], flow meter 14 used to calculate the amount of breath exhaled and hence the amount of breath collected in the gas container 6).
It would have been obvious to the skilled artisan modify Pan such that the breath sampler further comprises a volumetric breath quantifier configured to measure a volume of breath delivered to the sample outlet in view of the teachings of Dompeling, for the obvious advantage of calculating the amount of breath exhaled and hence the amount of breath collected in the gas container (Dompeling, para. [0037).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Pan in view of Chua, further in view of Dompeling, as applied to claim 5 above, and further in view of King-Smith (US 20170035326 A1).
Regarding claim 6, Pan further discloses the breath sampler according to claim 5. Pan does not expressly wherein the volumetric breath quantifier is configured to separate the breath sample into at least two sub-samples.
However, King-Smith discloses wherein the volumetric breath quantifier is configured to separate the breath sample into at least two sub-samples (figure 6, para.[0065, 0116-0118], the Exhaled Air Sampler 320 will direct a volume of exhaled air through the optional Filter 800 into the Concentrator 600; multiple Compartments 714 may hold a unique Ionic Liquid or the same Ionic Liquid as another Compartment and by mixing and matching the Ionic Liquid, different VOCs can be preferentially adsorbed by the Ionic Liquid in different Compartments; and a breath sample may be steered to one or all of the Ionic Liquid Containers at different times and by doing so, the location of a cancer within the lungs may be identified).
It would have been obvious to the skilled artisan to modify Pan such that the volumetric breath quantifier is configured to separate the breath sample into at least two sub-samples, in view of the teachings of King-Smith, for the obvious advantage of incorporating the multiple compartments 714 of King-Smith into the container of Pan such that different VOCs can be preferentially adsorbed by the Ionic Liquid in different compartments and such that a breath sample may be steered to one or all of the Ionic Liquid Containers at different times and by doing so, the location of a cancer within the lungs may be identified (King-Smith, para. [0116-0117).
Regarding claim 7, Pan further discloses the breath sampler according to claim 6. Pan does not expressly disclose 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.
However, King-smith discloses wherein the volumetric breath quantifier further comprises a closure member (para. [0095], sealing mechanism) configured to selectively close the sample outlet to prevent a first sub-sample being delivered to the sample collection chamber (para. [0095, 0118, 0131], the Ionic Liquid Collector 710 may have a sealing mechanism that is automatically opened and closed by the Concentrator 600; a breath sample may be steered to one or all of the Ionic Liquid Containers at different times and by doing so, the location of a cancer within the lungs may be identified; if a multi-chamber Ionic Liquid Collector 710 is used it is possible to select Ionic Liquids that are preferential to the adsorption of particular VOCs).
It would have been obvious to the skilled artisan to modify Pan 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, in view of the teachings of King-Smith, for the obvious advantage of incorporating the multiple Ionic Liquid containers having sealing members and the automatic opening and closing of the sealing members of King-Smith such that Ionic Liquids that are preferential to the adsorption of particular VOCs are selected and a breath sample may be steered to one or all of the Ionic Liquid Containers at different times so that the location of a cancer within the lungs may be identified (King-Smith, para. [0095, 0118, 0131]).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Pan in view of Chua, further in view of Dompeling, further in view of King-Smith, as applied to claim 7 above, further in view of Ahmad (US 20170119280 A1), and further in view of Akouka (WO 2018071441 A1).
Regarding claim 8, Pan further discloses the breath sampler according to claim 7. Pan does not expressly disclose 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.
However, Ahmad discloses wherein the volumetric breath quantifier comprises a gear configured to open the closure member when a predetermined volume of breath has entered the volumetric breath quantifier (figures 70-71, para. [0073, 0320- 0323], volume of the breath sample through the flow path is greater than 350 ml; the processor controls a solenoid valve 10015, which is manipulated through the use of an actuating mechanism; solenoid valve 10105 is attached to a linear actuator 10110 that is controlled by a dial 10115 attached to gear 10120 that can be manipulated; the rotation of the gear directly influences the pivot angle of the solenoid valve 10105, which can provide variations in between the open and closed scenario; flow sensors 10125, 10130 in both flow paths 10135, 10140 to determine when the desired vented volume has been evacuated, when to switch flow paths, and when a test has been completed).
It would have been obvious to a skilled artisan to modify Pan wherein the volumetric breath quantifier comprises a gear configured to open the closure member when a predetermined volume of breath has entered the volumetric breath quantifier, in view of the teachings of Ahmad, for the obvious advantage of using flow sensors in the flow paths to determine when the desired vented volume has been evacuated, when to switch flow paths, and when a test has been completed and communicating with a processor which controls the valve through a linear actuator that is controlled by a dial attached to gear, and manipulating the gear to provide variations in between the open and closed scenario (Ahmad, para. [0320-0323).
The combination of Pan and Ahmad does not expressly disclose a Geneva gear.
However, Akouka directed to an inhaler and methods of use thereof as a device for use in administering medicament in powder form discloses a Geneva gear (figure 10, para. [0200], Geneva drive 1000). The instant application specification discloses a breath sampler apparatus and on page 11 lines 26-31 discloses the apparatus has a delivery port 510 facilitates a connection of a nebuliser, such as nebuliser 520, or similar breathing aide, and enables the delivery of medication such as bronchodilators, which is in the same technical field as Akouka directed to a device for use in administering medicament in powder form.
It would have been obvious to a skilled artisan to modify Pan wherein the volumetric breath quantifier comprises a Geneva gear, in view of the teachings of Akouka, as such a modification is merely a substitution of the gear of Ahmad for the Geneva gear of Akouka.
Regarding claim 9, Pan further discloses the breath sampler according to claim 8. Pan does not expressly disclose 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.
However, Ahmad discloses wherein the volumetric breath quantifier is positioned downstream of the outlet valve (figures 70-71, para. [0320-0323], first flow path contains flow sensor 10045 and solenoid valve 10015) 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 (figures 70-71, solenoid valve 10015; the pivot angle of the solenoid valve 10105 provides variations in between the open and closed scenario); a geared coupling between the turnstile and the gear (figures 70-71, para. [0320-0323],  linear actuator 10110, dial 10115, and gear 10120); wherein the turnstile is configured to move the gear from a first position to a second position (figures 70-71, para. [0320-0323], rotation of the gear directly influences the pivot angle of the solenoid valve 10105, which can provide variations in between the open and closed scenario identified in FIG. 70), and wherein movement of the Geneva gear from the first position to the second position is configured to open the closure member (figures 70-71, para. [0320-0323], rotation of the gear directly influences the pivot angle of the solenoid valve 10105, which can provide variations in between the open and closed scenario identified in FIG. 70).
It would have been obvious to a skilled artisan to modify Pan 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 gear; wherein the turnstile is configured to move the gear from a first position to a second position, and wherein movement of the gear from the first position to the second position is configured to open the closure member, in view of the teachings of Ahmad, for the obvious advantage of using flow sensors in the flow paths to determine when the desired vented volume has been evacuated, when to switch flow paths, and when a test has been completed and communicating with a processor which controls the valve through a linear actuator that is controlled by a dial attached to gear, and manipulating the gear to provide variations in between the open and closed scenario (Ahmad, para. [0320-0323)
The combination of Pan and Ahmad does not expressly disclose a Geneva gear.
However, Akouka discloses a Geneva gear (figure 10, para. [0200], Geneva drive 1000).
It would have been obvious to a skilled artisan to modify Pan wherein the volumetric breath quantifier comprises a Geneva gear, in view of the teachings of Akouka, as such a modification is merely a substitution of the gear of Ahmad for the Geneva gear of Akouka.
The combination of Pan, Ahmad, and Akouka does not expressly disclose opening the closure member to allow a second sub-sample to be delivered to the sample collection chamber.
However, King-Smith discloses opening the closure member to allow a second sub-sample to be delivered to the sample collection chamber (para.[0095, 0118, 0131], the Ionic Liquid Collector 710 may have a sealing mechanism that is automatically opened and closed by the Concentrator 600; a breath sample may be steered to one or all of the Ionic Liquid Containers at different times and by doing so, the location of a cancer within the lungs may be identified; if a multi-chamber Ionic Liquid Collector 710 is used it is possible to select Ionic Liquids that are preferential to the adsorption of particular VOCs).
It would have been obvious to a skilled artisan to modify Pan for opening the closure member to allow a second sub-sample to be delivered to the sample collection chamber, in view of the teachings of King-Smith, for the obvious advantage of selecting Ionic Liquids that are preferential to the adsorption of particular VOCs and steering the breath sample to one or all of the Ionic Liquid Containers at different times so that the location of a cancer within the lungs may be identified (King-Smith, para. [0095, 0118, 0131]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Pan in view of Chua, as applied to claim 1 above, and further in view of Eichler (US 20160338616 A1).
Regarding claim 13, Pan further discloses the breath sampler according to claim 1. Pan does not disclose a delivery port in fluid communication with the non-rebreather part, configured for connection to a nebuliser.
However, Eichler discloses a delivery port (valve 22) in fluid communication with the non- rebreather part (air distributor 1), configured for connection to a nebulizer (“nebulizer”, para. [0103]).
It would have been obvious to a skilled artisan to modify Pan to further comprise a delivery port in fluid communication with the non-rebreather part, configured for connection to a nebuliser, in view of the teachings of Eichler, for the obvious advantage of incorporating the separate air inlet and liquid dispensing device of Eichler to generate an aerosol mist in the direction of flow in front of the through-flow sensor such that a tempering of the through-flow sensor through humification can be conducted as a separate method step (Eichler, paragraph [0103]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Pan in view of Chua, as applied to claim 14 above, and further in view of Meka (US 20070173731 A1).
Regarding claim 15, Pan further discloses the breath sampler according to claim 14.  Pan does not disclose wherein the integrated testing module is a lab-on-chip device.
However, Meka discloses wherein the integrated testing module is a lab-on-chip device (figure 1A, paragraph [0046], a miniaturized analysis chip 54, may contain microfluidic handling capability, then processes the fluid such that constituent chemical, biochemical, and biological species can be identified and/or quantified).
It would have been obvious to the skilled artisan to modify Pan wherein the integrated testing module is a lab-on-chip device, in view of the teachings of Meka, for the obvious advantage of incorporating the miniaturized analysis chip of Meka such that the analysis chip processes the fluid such that constituent chemical, biochemical, and biological species can be identified and/or quantified (Meka, paragraph [0046]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Pan in view of Chua, as applied to claim 14 above, and further in view of Ku (US 20120004571 A1).
Regarding claim 16, Pan further discloses the breath sampler according to claim 14.  Pan does not disclose wherein the integrated testing module comprises a PCR unit (para. [0064, 0070], one or more detectors 441 operable to detect the presence or absence of a bacteria, virus, fungus, antibody, protein, or chemical such as carbon dioxide, carbon monoxide, nitric oxide, alcohol; detection of material from either the upper airway or the lower airway is optionally by polymerase chain reaction (PCR), real-time PCR, reverse-transcription PCR).
However, Ku discloses wherein the integrated testing module comprises a PCR unit.
It would have been obvious to the skilled artisan to modify Pan wherein the integrated testing module comprises a PCR unit, in view of the teachings of Ku, for the obvious advantage of using polymerase chain reaction (PCR), real-time PCR, reverse-transcription PCR to detect material (bacteria, virus, fungus, antibody, protein, or chemical such as carbon dioxide, carbon monoxide, nitric oxide, alcohol) from either the upper airway or the lower airway (Ku, para. [0064, 0070]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable Pan in view of Chua, as applied to claim 1 above, further in view of Eichler and further in view of Lui (US 20150072889 A1).
Regarding claim 17, Pan further discloses the breath sampler according to claim 1. Pan does not disclose wherein at least one of the non-rebreather part and the sample delivery part comprises a sensor configured to measure additional biomarkers, including one or more of: nucleic acids, cytokines, chemokines, C- reactive protein, hosts and/or pathogens.
However, Eichler discloses wherein at least one of the non-rebreather part and the sample delivery part comprises a sensor (paragraphs [0018, 0084], through-flow sensor 6 installed in a flow guide tube 8; is preferably a sensor selected from the group “electrochemical sensors, biochemical sensors, enzymatic sensors, chemiluminescence sensors, NO sensors, O2 sensors, H2O2 sensors, CO2 sensors, CO sensors”).
However, Lui directed to systems, methods, and devices for detecting infections in a clinical sample discloses a sensor (paragraph [0088], an optical sensor) configured to measure additional biomarkers, including one or more of: nucleic acids, cytokines, chemokines, C- reactive protein, hosts and/or pathogens (paragraphs [0032, 0043, 0227, 0368], performing two or more assays for the detection of disease markers; disease markers are selected from; a nucleic acid disease marker; a cytokine; C-reactive protein; testing a sample or samples for a marker for inflammation; a chemokine; a sample may be a breath sample; a sample processing device may be configured to detect, or to identify, or to measure pathogen-identifying material).
It would have been obvious to the skilled artisan to modify Pan wherein at least one of the non-rebreather part and the sample delivery part comprises a sensor configured to measure additional biomarkers, including one or more of: nucleic acids, cytokines, chemokines, C- reactive protein, hosts and/or pathogens, in view of the teachings of Eichler and Lui, for the obvious advantage of detecting disease markers or inflammation markers selected from nucleic acid disease markers, cytokines, C-reactive proteins, chemokines, to detect pathogen-identifying material (Lui, para. [0032, 0043, 0028, 0368]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Pan in view of Chua, as applied to claim 14 above, and further in view of Phillips (US 5465728 A).
Regarding claim 18, Pan further discloses the breath sampler according to claim 1, an exhaust (119) and a filter or mesh (para. [0043], “gas permeable filter”). Pan does not disclose wherein the exhaust comprises the filter or mesh.
However, Phillips discloses wherein the exhaust comprises a filter or mesh (figure 4, column 4 lines 19-20 and column 6 lines 47-48, end 16 is essentially closed, vented by a breath exit portal 20; vent 20 includes a microorganism filter 56 and a respirometer 58).
18. (Previously presented) The breath sampler according to claim 1, wherein the exhaust comprises a filter or mesh.
It would have been obvious to the skilled artisan to modify Pan wherein the exhaust comprises the filter or mesh, in view of the teachings of Phillips, for the obvious advantage of trapping microorganisms and preventing the microorganisms from escaping the permeable filter (Phillips, column 6 lines 47-48 and Pan, para. [0043]).
Claim 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Pan in view of Chua, as applied to claim 14 above, as applied to claim 14 above, and further in view of Kline (US 20040138577 A1).
Regarding claim 19, Pan further discloses the breath sampler according to claim 1. Pan does not disclose 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.
However, Kline discloses 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 (paragraphs [0066, 0069], outlet cap 60 is preferably disposed at the end of the central chamber 324 opposite the inlet 36; facilitates the passage of exhaled air through the central chamber 324 in only a single direction; outlet cap 60 may be removed without danger of the condensate inside the syringe 320 escaping).
It would have been obvious to the skilled artisan to modify Pan to further comprise 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, in view of the teachings of Kline, for the obvious advantage of incorporating the outlet cap onto the vent 119 of Pan for facilitating the passage of exhaled air through the central chamber 324 in only a single direction and being removable without danger of the condensate inside the syringe 320 escaping (Kline, para. [0066, 0069]).
Regarding claim 20, Pan further discloses the breath sampler according to claim 19. Pan does not disclose the wherein the sampler cap is arranged to cover the exhaust.
However, Kline discloses wherein the sampler cap is arranged to cover the exhaust (para. [0066, 0069], outlet cap 60 is preferably disposed at the end of the central chamber 324 opposite the inlet 36; facilitates the passage of exhaled air through the central chamber 324 in only a single direction; outlet cap 60 may be removed without danger of the condensate inside the syringe 320 escaping).
It would have been obvious to the skilled artisan to modify Pan such that the sampler cap is arranged to cover the exhaust as disclosed by Kline, as such a modification would have been predictable, namely incorporating into the vent 119, of Pan, the outlet cap 60, of Kline, such that the outlet cap facilitates the passage of exhaled air through the central chamber 324 in only a single direction and may be removed without danger of the condensate inside the syringe 320 escaping (Kline, paragraphs [0066, 0069]).
Regarding claim 21, Pan further discloses the breath sampler according to claim 19. Pan does not disclose wherein the sampler cap comprises connection means corresponding to the sample collection chamber.
However, Kline discloses wherein the sampler cap comprises connection means corresponding to the sample collection chamber (paragraphs [0065-0066, 0069], syringe 320 defines a central chamber 324; outlet cap 60 includes an outlet 338 and a second valve 342, which is an exit valve disposed in or adjacent to the outlet 338 in order to facilitate the passage of exhaled air through the central chamber 324 in only a single direction; outlet cap 60 may be removed without danger of the condensate inside the syringe 320 escaping; suitable connection means, such as corresponding screw threads or the like, are preferably provided on the syringe 320 and the outlet cap 60 to facilitate such removal).
It would have been obvious to the skilled artisan to modify Pan wherein the sampler cap comprises connection means corresponding to the sample collection chamber as disclosed by Kline, as such a modification would have been predictable, namely incorporating into the vent 119, of Pan, the outlet cap 60, of Kline, such that the outlet cap facilitates the passage of exhaled air through the central chamber 324 in only a single direction and may be removed without danger of the condensate inside the syringe 320 escaping (Kline, paragraphs [0066, 0069]).
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 1-4, 10, 11, and 14 stand rejected under 35 U.S.C. § 103 as allegedly being unpatentable over U.S. Patent Application Publication No. 2021/0093226 to Dr Moschos in view of U.S. Patent Application Publication No. 2004/0077093 to Pan, U.S. Patent Application Publication No. 2018/0110444 to Sherwood et al., and U.S. Patent No. 10,195,147 to Yadidi.
Further, claim 5 stands rejected under 35 U.S.C. § 103 as allegedly being unpatentable over Dr Moschos in view of Pan, Sherwood, Yadidi, and U. S. Patent Application Publication No. 2010/0292601 to Dompeling et al.; claims 6 and 7 stand rejected under 35 U.S.C. § 103 as allegedly being unpatentable over Dr Moschos in view of Pan, Sherwood, Yadidi, Dompeling, and U.S. Patent Application Publication No. 2017/0035326 to King-Smith; claims 8 and 9 stand rejected under 35 U.S.C. § 103 as allegedly being unpatentable over Dr Moschos in view of Pan, Sherwood, Yadidi, Dompeling, King-Smith, U.S. Patent Application Publication No. 2017/0119280 to Ahmad et al., and International Patent Application Publication No. WO 2018/071441 to Akouka et al.; claim 13 stands rejected under 35 U. S. C. § 103 as allegedly being unpatentable over Dr Moschos in view of Pan, Sherwood, Yadidi, and U. S. Patent Application Publication No. 2016/0338616 to Eichler; claim 15 stands rejected under 35 U.S.C. § 103 as allegedly being unpatentable over Dr Moschos in view of Pan, Sherwood, Yadidi, and U.S. Patent Application Publication No. 2007/0173731 to Meka et al.; claim 16 stands rejected under 35 U.S.C. § 103 as allegedly being unpatentable over Dr Moschos in view of Pan, Sherwood, Yadidi, and U.S. Patent Application Publication No. 2012/0004571 to Ku et al.; claim 17 stands rejected under 35 U. S. C. § 103 as allegedly being unpatentable over Dr Moschos in view of Pan, Sherwood, Yadidi, 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 Dr Moschos in view of Pan, Sherwood, Yadidi, 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 Dr Moschos in view of Pan, Sherwood, Yadidi, and U.S. Patent Application Publication No. 2004/0138577 to Kline.
The rejection is respectfully traversed for at least the following reasons.
Independent claim 1 recites, in combination with other features, a sample delivery part that comprises an air diverter arranged to divide the sample delivery part into an upstream portion and a downstream portion. A breath sampler having at least this feature in combination with the other features set forth in claim 1 is neither derivable from nor rendered obvious by the cited references.
The Official Action acknowledges that Dr Moschos does not disclose the recited air diverter, and therefore, further cites Sherwood to supposedly remedy the deficiency (See Official Action, top of page 10 and the first paragraph on page 11).
Sherwood concerns a gas sampling device that includes a diverter valve (1050) or other component that is configured to selectively route exhaled air to either the exhaust post (1054) or the gas testing chamber (1026) (see para. [0086]). As is clear from at least Fig. 10 of Sherwood, the diverter valve is movable between two different positions - a first position, as illustrated in Fig. 10, that blocks the exhaled air from entering the gas chamber (1026) and permitting passage of the exhaled air through the exhaust port (1054); and a second position, as indicated by the arrow on the air diverter in Fig. 10, that permits entry of the exhaled air into the gas chamber (1026) and blocks the exhaled air from passing through the exhaust port (1054). Sherwood also explains that this arrangement is advantageous so that the patient's exhaled air is sampled at an optimum point (see para. [0087], which provides "the data collected by the sensor 1052 can dictate whether the exhaled air is exhausted from the housing 1020 or collected as sample gas in the gas testing chamber 1026. For example, the CO2 content of the air from the patient can be monitored and the exhaled air can be diverted to the gas testing chamber 1026 when the CO2 content plateaus").
Based on Sherwood, the Official Action has taken the position that it would have been obvious to substitute the wall (dividing member 128) of Dr Moschos for the diverter valve of Sherwood to selectively route air (See Official Action, bottom of page 12). However, if the ordinary skilled person were to have modified Dr Moschos' exhaled breath condensate collection device to have Sherwood's diverter valve in place of the dividing member as proposed by the Official Action, the diverter valve would necessarily interfere with the flow path of an exhaled breath through Dr Moschos device.
In particular, the dividing member of Dr Moschos divides the breath sampler into the first chamber 130 and the second chamber (i.e., non-rebreather part and sample delivery part) and not the second chamber (sample delivery part) into two parts like the air diverter of claim 1. Substituting the diverter valve for the dividing member would modify the boundary between the
two chambers and would necessarily affect the flow of air from the breath inlet tube 132 to the breath outlet port 124. More specifically, arranging the diverter valve in place of the dividing member would
either
permit the exhaled breath to flow normally (as intended in Dr Moschos) from the breath inlet port 122 through the breath outlet port 124 (when the diverter valve is in the first position that blocks the exhaled air from entering the gas chamber and permits passage of the exhaled air through the exhaust port) or block the exhaled breath from flowing through the breath outlet port 124 entirely (when the diverter vale is in the second position that permits entry of the exhaled air into the gas chamber and blocks the exhaled air from passing through the exhaust post).
Given that both the sample delivery part (second chamber of annotated Fig. la)
an
d
the exhaust (exhaust outlet port 140) are arranged downstream of the dividing member in Dr Moschos, substituting the diverter valve in place of the dividing member would also not have the same intended effect as Sherwood's diverter valve, i.e. selectively routing the exhaled air to one of the exhaust port or the gas testing chamber. Not to mention, the second position of the diverter valve (that blocks the exhaled breath from passing through the exhaust port) would be problematic since an exhaled breath would be blocked from flowing through the breath outlet port (124) and would have no other way of exiting from the device apart from through the point of entry therein (at breath inlet port 122).
For at least these reasons, it is respectfully submitted that even if the ordinary skilled person had been equipped with Sherwood, if and when seeking to modify the exhaled breath condensate collection device of Dr Moschos, he/she still would not have been directed to arrive at the breath sampler set forth in claim 1. Further, Pan and Yadidi both fail to teach or suggest the recited air diverter, and as such, neither document can reasonably be applied to remedy the aforementioned deficiencies of Dr Moschos and Sherwood.
For the sake of completeness, it is recognized that 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. Dompeling, King-Smith, Ahmad, Akouka, Eichler, Meka, Ku, Lui, Phillips, and Kline each lack any disclosure or reasonable suggestion of the recited air diverter. Consequently, none of Dompeling, King-Smith, Ahmad, Akouka, Eichler, Meka, Ku, Lui, Phillips, and Kline can be applied to remedy the aforementioned deficiencies of Dr Moschos, Pan, Sherwood, and Yadidi.
For at least the reasons discussed herein, it is respectfully submitted that the disclosures in Dr Moschos, Pan, Sherwood, Yadidi, 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,

NEXT 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

CITED REFERENCE SUMMARIES: Ref US20140276169A1: Claims:
A nasal cannula comprising: an elongate face piece comprising first and second nares, and the first nare facilitates communication with a first nostril of a patient while the second nare facilitates communication with a second nostril of the patient; a septum dividing the face piece into first and second flow paths such that the first flow path communicating with the first nare and the second flow path communicating with the second nare; a leading end of the first nare being configured to form a fluid barrier within a first nostril of the patient to facilitate only supplying an insufflation gas, via the first flow path, to the patient and prevent exhausting any of an exhaust gas, from the patient, through the first nostril of the patient; and a leading end of the second nare being configured to facilitate collecting some of the exhaust gas, from the patient, via the second flow path as well as exhausting a remainder of the exhaust gas, from the patient, out through the second nostril of the patient.
an elongate face piece comprising first and second nares, and the first nare facilitates communication with a first nostril of a patient while the second nare facilitates communication with a second nostril of the patient;
a septum dividing the face piece into first and second flow paths such that the first flow path communicating with the first nare and the second flow path communicating with the second nare;
a leading end of the first nare being configured to form a fluid barrier within a first nostril of the patient to facilitate only supplying an insufflation gas, via the first flow path, to the patient and prevent exhausting any of an exhaust gas, from the patient, through the first nostril of the patient; and
a leading end of the second nare being configured to facilitate collecting some of the exhaust gas, from the patient, via the second flow path as well as exhausting a remainder of the exhaust gas, from the patient, out through the second nostril of the patient.
The nasal cannula according to claim 1 , wherein the nasal cannula is tubular and the septum is disposed generally centered within the face piece, between a pair of respective flow passages, which facilitate communication with the respective first and second nares.
The nasal cannula according to claim 1 , wherein a first opening is formed in a first end of the face piece while a second opening is formed in an opposite second end of the face piece, and a supply tube is connected to the first opening, while a detection tube is connected to the second opening.
The nasal cannula according to claim 3 , wherein a second opposed end of the supply tube is connected to a source of an insufflating gas while a second opposed end of the detection tube is connected to a carbon dioxide monitoring device.
The nasal cannula according to claim 1 , wherein at least one opening is formed in a sidewall of the first nare.
The nasal cannula according to claim 5 , wherein the at least one opening in the first nare has a diameter of between 0.05 and 0.07 inches.
The nasal cannula according to claim 5 , wherein the at least one opening in the first nare permits the insufflating gas to collect and accumulate temporarily in a nasal region closely surrounding and adjacent the first nare, so that the accumulated insufflating gas may then reenter into the first nare, through the at least one opening, and be inhaled by the patient and maximize the insufflating gas delivered to the patient.
The nasal cannula according to claim 5 , wherein the first nare has a one-way valve which, when open, permits the flow of the insufflating gas into the first nostril of the patient, and when closed, prevents the flow of the exhaust gas from the patient into the first nare.
The nasal cannula according to claim 1 , wherein at least one opening is formed in a sidewall of the second nare, and the at least one opening prevents an undesirable level of suction from developing at an inlet of a tip of the second nare, thereby preventing drawing the tip of the second nare into contact with nasal tissue, and preventing occlusion of the inlet of the second nare.
The nasal cannula according to claim 7 , wherein the at least one opening in the second nare has a diameter of between 0.05 and 0.07 inches.
The nasal cannula according to claim 1 , wherein the first nare has a peripheral sealing member which snugly engages with adjacent tissue of a nasal passage of the first nostril of the patient, once the first nare is located therein, so as to form a perimeter nasal seal.
The nasal cannula according to claim 11 , wherein the peripheral sealing member is located at a leading end of the first nare and has an inverted mushroom shape head which is sized, shaped and configured so as to intimately and snugly engage with adjacent tissue of the nasal passage of the first nostril of the patient and thereby form a perimeter nasal seal therewith which prevents passage of any exhaust gas, from the patient, through the first nostril and also prevents inhalation of any room air via the first nostril past the perimeter nasal seal.
The nasal cannula according to claim 1 , wherein a flexible one-way valve covers and seals an outlet of the first nare to assist with converting the first nostril, which receives the first nare, into a dedicated insufflation nostril which only permits the supply of the insufflating gas to the patient.
The nasal cannula according to claim 13 , wherein the one-way valve comprises a sealed opening which is provided with at least one slit, and the one-way valve of the first nare is normally biased into a closed position so as to prevent any exhaust gas, during exhalation of the patient, from flowing into the outlet of the first nare while, during inhalation of the patient, allowing the insufflating gas to flow past the one-way valve into the first nostril and be inhaled by the patient.
The nasal cannula according to claim 1 , wherein the second nare is sized to be smaller than the second nostril so as to permit exhalation of the exhaust gases, of the patient, via the second nostril of the patient which receives the second nare.
The nasal cannula according to claim 15 , wherein the second nostril which receives the second nare is a dedicated sampling nostril for exhausting the exhaust gas from the patient and for measuring the end tidal CO, of the patient, and a transverse cross-sectional area of the second nare occupies approximately 50% or less than a total transverse cross-sectional area of the second nostril so as to provide a sufficient open and unobstructive cross sectional area to facilitate exhausting the exhaust gas of the patient while still facilitating measurement of the end tidal CO, of the patient
The nasal cannula according to claim 2 , wherein a first opening is formed in a first end of the face piece while a second opening is formed in the opposite second end of the face piece, and an oxygen supply tube is connected to the first opening while an end-tidal CO, detection tube is connected to the second opening, a second opposed end of the oxygen supply tube is connected to a source of an oxygen gas while a second opposed end of the end-tidal CO, detection tube is connected to a carbon dioxide monitoring device.
A nasal cannula comprising: an elongate face piece comprising first and second nares, and the first nare facilitates communication with a first nostril of a patient while the second nare facilitates communication with a second nostril of the patient; a septum dividing the face piece into first and second flow paths such that the first flow path communicates with the first nare and the second flow path communicates with the second nare; a leading end of the first nare being configured to form a fluid barrier within the first nostril of the patient to facilitate only supplying an insufflation gas, via the first flow path, to the patient and prevent exhaust any of exhaust gas, from the patient, through the first nostril of the patient; at least one opening being formed in a sidewall of the first nare, and the at least one opening in the first nare permits the insufflating gas to collect and accumulate temporarily in a nasal region closely surrounding and adjacent the first nare, and reenter into the first nare, through the at least one opening, and be inhaled by the patient during inhalation by the patient; a leading end of the second nare being configured to facilitate collection of some of the exhaust gas, from the patient, via the second flow path as well as exhausting a remainder of the exhaust gas, from the patient, out through the second nostril of the patient; and a first opening being formed in a first end of the face piece while a second opening being formed in the opposite second end of the face piece, an oxygen supply tube being connected to the first opening while an end-tidal CO 2 detection tube being connected to the second opening, a second opposed end of the oxygen supply tube being connected to a source of an oxygen gas while a second opposed end of the end-tidal CO 2 detection tube being connected to a carbon dioxide monitoring device.
a septum dividing the face piece into first and second flow paths such that the first flow path communicates with the first nare and the second flow path communicates with the second nare;
a leading end of the first nare being configured to form a fluid barrier within the first nostril of the patient to facilitate only supplying an insufflation gas, via the first flow path, to the patient and prevent exhaust any of exhaust gas, from the patient, through the first nostril of the patient;
at least one opening being formed in a sidewall of the first nare, and the at least one opening in the first nare permits the insufflating gas to collect and accumulate temporarily in a nasal region closely surrounding and adjacent the first nare, and reenter into the first nare, through the at least one opening, and be inhaled by the patient during inhalation by the patient;
a leading end of the second nare being configured to facilitate collection of some of the exhaust gas, from the patient, via the second flow path as well as exhausting a remainder of the exhaust gas, from the patient, out through the second nostril of the patient; and
a first opening being formed in a first end of the face piece while a second opening being formed in the opposite second end of the face piece, an oxygen supply tube being connected to the first opening while an end-tidal CO 2 detection tube being connected to the second opening, a second opposed end of the oxygen supply tube being connected to a source of an oxygen gas while a second opposed end of the end-tidal CO 2 detection tube being connected to a carbon dioxide monitoring device.
The nasal cannula according to claim 18 , wherein the first nare has a one-way valve which, when open, permits the flow of the insufflating gas into a nostril of the patient, and when closed, prevents the flow of exhaust gases into the first nare, and at least one opening is formed in a sidewall of the second nare, and the at least one opening in the second nare prevents an undesirable level of suction, at an inlet of the second nare, from developing and drawing the inlet of the second nare into nasal tissue and occluding the inlet of the second nare.
A method of improving measurement of end tidal CO 2 gas exhaled by a patient with a divided cannula which comprises an elongate face piece comprising first and second nares, and the first nare facilitates communication with a first nostril of the patient while the second nare facilitates communication with a second nostril of the patient; a septum dividing the face piece into first and second flow paths such that the first flow path communicating with the first nare and the first nostril and the second flow path communicating with the second nare and the second nostril; a leading end of the first nare being configured to form a fluid barrier within the first nostril of the patient to facilitate only supplying an insufflation gas, via the first flow path, to the patient and prevent exhausting any of exhaust gas, from the patient, through the first nostril of the patient; and a leading end of the second nare being configured to facilitate collecting some of the exhaust gas, from the patient, via the second flow path as well as exhausting a remainder of the exhaust gas, from the patient, out through a second nostril of the patient; the method comprising the steps of: dedicating the first nostril of the patient for solely supplying the insufflation gas to the patient and preventing exhausting any exhaust gas through the first nostril; and dedicating the second nostril of the patient for solely exhaling gas from the patient and sampling the end tidal CO 2 gas, exhaled by the patient, via the second nare.
dedicating the first nostril of the patient for solely supplying the insufflation gas to the patient and preventing exhausting any exhaust gas through the first nostril; and
dedicating the second nostril of the patient for solely exhaling gas from the patient and sampling the end tidal CO 2 gas, exhaled by the patient, via the second nare.
Ref US10086166B1: Claims:
A demand gas valve apparatus, comprising: a housing having a proximal end and a distal end, said housing defining a longitudinal axis and defining an internal passage extending between said distal end and said proximal end of said housing, such that gas can pass from said distal end to said proximal end through said internal passage; a transverse divider wall disposed within said housing and including a valve seat, said transverse divider wall dividing said housing into a proximal compartment and a distal compartment located respectively on opposite sides of said valve seat, said internal passage including an opening disposed through said transverse divider wall; a valve member disposed within said housing and including a piston and a stem, wherein said stem extends axially from said piston through said opening from said proximal compartment into said distal compartment; a resilient bias member disposed within said distal compartment of said housing and in communication with said valve member, such that said valve member and said resilient bias member move congruent with one another with said resilient bias member causing axial movement of said stem within said opening, a retainer washer coupled to said stem in proximity to a distal tip of said stem, wherein a proximal end of said resilient bias member engages or is otherwise disposed adjacent to said transverse divider wall, wherein a distal end of said resilient bias member engages or is positioned directly adjacent to said retainer washer, such that said resilient bias member is maintained on its proximal end by said transverse divider wall and on its distal end by said retainer washer; and a sleeve extending distally from said transverse divider wall into said distal compartment, said sleeve surrounding said resilient bias member, said valve apparatus having a closed position and an open position, said closed position of said valve apparatus being a default position in the absence of negative pressure along said proximal end of said housing, such that gas cannot pass from said distal end to said proximal end through said internal passage of said housing, said resilient bias member not being under any stress or force in said closed position, wherein said resilient bias member maintains said valve member in said closed position as said default position, said piston positioned in said proximal compartment directly adjacent to said valve seat in said closed position, wherein said piston engages said valve seat to fully obstruct said opening of said internal passage in said closed position, thus preventing flow of gas through said internal passage, said open position occurring due to axial movement of said valve member and said resilient bias member as a result of the presence of negative pressure along said proximal end of said housing, such that gas can pass from said distal end to said proximal end through said internal passage of said housing, said resilient bias member being under a stress or force caused by said negative pressure in said open position, wherein at least a portion of said valve member moves axially within said internal passage, said opening of said internal passage being only partially obstructed by said valve member or not obstructed at all in said open position, thus permitting flow of gas through said internal passage, wherein said retainer washer contacts said sleeve in said open position to prevent said valve member and said resilient bias member from traversing further proximally when said demand valve transitions from said closed position to said open position.
a housing having a proximal end and a distal end, said housing defining a longitudinal axis and defining an internal passage extending between said distal end and said proximal end of said housing, such that gas can pass from said distal end to said proximal end through said internal passage;
a transverse divider wall disposed within said housing and including a valve seat, said transverse divider wall dividing said housing into a proximal compartment and a distal compartment located respectively on opposite sides of said valve seat,
said internal passage including an opening disposed through said transverse divider wall;
a valve member disposed within said housing and including a piston and a stem, wherein said stem extends axially from said piston through said opening from said proximal compartment into said distal compartment;
a resilient bias member disposed within said distal compartment of said housing and in communication with said valve member, such that said valve member and said resilient bias member move congruent with one another with said resilient bias member causing axial movement of said stem within said opening,
a retainer washer coupled to said stem in proximity to a distal tip of said stem,
wherein a proximal end of said resilient bias member engages or is otherwise disposed adjacent to said transverse divider wall,
wherein a distal end of said resilient bias member engages or is positioned directly adjacent to said retainer washer, such that said resilient bias member is maintained on its proximal end by said transverse divider wall and on its distal end by said retainer washer; and
a sleeve extending distally from said transverse divider wall into said distal compartment, said sleeve surrounding said resilient bias member,
said valve apparatus having a closed position and an open position, said closed position of said valve apparatus being a default position in the absence of negative pressure along said proximal end of said housing, such that gas cannot pass from said distal end to said proximal end through said internal passage of said housing,
said resilient bias member not being under any stress or force in said closed position, wherein said resilient bias member maintains said valve member in said closed position as said default position,
said piston positioned in said proximal compartment directly adjacent to said valve seat in said closed position, wherein said piston engages said valve seat to fully obstruct said opening of said internal passage in said closed position, thus preventing flow of gas through said internal passage,
said open position occurring due to axial movement of said valve member and said resilient bias member as a result of the presence of negative pressure along said proximal end of said housing, such that gas can pass from said distal end to said proximal end through said internal passage of said housing,
said resilient bias member being under a stress or force caused by said negative pressure in said open position,
wherein at least a portion of said valve member moves axially within said internal passage,
said opening of 
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