Office Action 1: Non-Final Rejection (2023-12-28)
Rejection types: 103 - Obviousness, 112 - Written Description/Enablement

CLAIMS:
AMENDMENTS TO THE CLAIMS

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

LISTING OF CLAIMS:

1\. (Currently amended) 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 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 valv , 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 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 chambers 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\. (Currently amended) 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 interfac , and wherein the sample delivery tube is removably connected to the sample outlet.

3\. (Currently amended) 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\. (Currently amended) 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\. (Currently amended) 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\. (Currently amended) 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\. (Currently amended) The breath sampler according to claim 6, wherein the volumetric breath sampler 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\. (Currently amended) 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\. (Currently amended) 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\. (Currently amended) The breath sampler according to claim 1, further comprising a plurality of selectively connectable modules.

11\. (Currently amended) 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\. (Currently amended) 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\. (Currently amended) The breath sampler according to claim 1, wherein the sample collection chamber further comprises an integrated testing module .

15\. (Currently amended) The breath sampler according to claim 14, wherein the integrated testing module is a lab-on-chip device.

16\. (Currently amended) The breath sampler according to claim 14 , wherein the integrated testing module comprises a PCR unit.

17\. (Currently amended) 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/of pathogens.

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

19\. (Currently amended) 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\. (Currently amended) The breath sampler according to claim 19, wherein the sampler cap is arranged to cover the exhaust .

21\. (Currently amended) The breath sampler according to claim 19, wherein the sampler cap comprises connection means corresponding to the sample collection chamber .
\-3- -4- -5- -6- Attorney Docket No.: P6075123PCT/US

OFFICE ACTION:
Notice of Pre-AIA  or AIA  Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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: “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 as a wall (page 13 line 28); 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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b)  CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 and 13-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA  35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation the breath from the patient in lines 25-26.  There is insufficient antecedent basis for this limitation in the claim. The limitation should recite the breath sample from the patient.
Claims 2-11 and 13-21 are rejected by virtue of depending from rejection claim 1.
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 1-4, 10-11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Dr Moschos (US 20210093226 A1) in view of Pan (US 20040077093 A1), further in view of Sherwood et al. (US 20180110444 A1) (herein Sherwood).
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Annotated figures 1A and 11 of Dr Moschos
Regarding claim 1, Dr Moschos discloses a breath sampler for collecting a breath sample from a patient, the breath sampler (figure 13, paragraphs [0001, 0086], an exhaled breath condensate collection device; mouthpiece module 100 and collection vessel housing 200) comprising: a non-rebreather part (figure 13, paragraph [0086], mouthpiece module 100) comprising: a sample inlet (figure 1, paragraph [0074], a mouthpiece breath inlet port 122 and mouthpiece breath inlet tube 132); an outlet arranged to allow air to exit the non-rebreather part (figure 1a, mouthpiece breath outlet tube 134) the outlet and the sample inlet defining a first portion of an internal breath flow pathway therebetween (figure 1a, paragraph [0074], mouthpiece first chamber 130; mouthpiece breath inlet tube 132 and mouthpiece breath outlet tube 134 providing a breath passageway from within the mouthpiece first chamber 130); and a sample delivery part in fluid communication with the non-rebreather part at an upstream end via the outlet (annotated figure 1a,  paragraph [0090], collection vessel has a vessel breath inlet (326) for admitting exhaled breath into the chamber; and in fluid communication with the mouthpiece breath outlet port (124))), the sample delivery part defining a second portion of the internal breath flow pathway (annotated figure 1A, second chamber), the sample delivery part (annotated figure 1A, paragraphs [0074, 0090], second chamber having mouthpiece breath outlet port 124 in fluid communication with vessel breath inlet 326, and mouthpiece exhaust tube 138) comprising: a sample outlet in the upstream portion (figure 1a, paragraphs [0074, 0082], mouthpiece breath outlet tube 134 and mouthpiece breath outlet port 124; vessel breath tube 330); a return inlet in the downstream portion and in fluid communication with an exhaust (figure 4, paragraphs [0074, 0077, 0082, 0087], mouthpiece exhaust inlet port 136; a mouthpiece exhaust outlet port 140 at a downstream end; vessel exhaust tube 332; and mouthpiece exhaust 164 through which exhaled breath can exit the device); and a sample collection chamber connector (paragraphs [0086], recess connection members 170) configured to form a seal with an opening of a sample collection chamber (figures 10 and 13-14, paragraphs [0086-0087], collection vessel housing 200 is typically attached to the mouthpiece module 100 whilst the mouthpiece is in the sealed configuration; lip 324 acts to withdraw the sliding lid 322 whereby to expose the sealing film (not shown) covering the openings of the vessel breath inlet 326 and the vessel exhaust outlet 328), the connector defining a perimeter (annotated figure 11, paragraph [0086], recess connection members 170 having a perimeter), the sample outlet and the return inlet being disposed within the perimeter (annotated figure 11, paragraphs [0085- 0086], recess connection members 170 having a perimeter having mouthpiece exhaust inlet port 136 and mouthpiece breath outlet port 124), wherein the breath sampler further comprises the sample collection chamber coupled to the sample collection chamber connector (figure 14, paragraphs [0086-0087], collection vessel housing 200 is mounted to the mouthpiece module 100; collection vessel 300 is inserted into the collection vessel housing 200 through the collection vessel receiving opening 206), wherein the breath sampler is configured so that, during operation, the breath from the patient passes through the non-rebreather part (paragraph [0074], first chamber 130; mouthpiece breath inlet port 122 configured to receive exhaled breath from a subject and a mouthpiece breath outlet port 124 arranged to be in fluid communication with the mouthpiece breath inlet port 122 to form a breath passageway and to output exhaled breath out of the mouthpiece module 100), is delivered via the sample delivery part to the sample outlet into the sample collection chamber (paragraph [0090], fluid conduction from a mouthpiece breath inlet port (122) for receiving exhaled breath to a mouthpiece breath outlet port (124); and collection vessel (300) defines a sealed and resealable chamber for collecting exhaled breath condensate in use; having breath inlet (326) for admitting exhaled breath into the chamber, 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 (paragraphs [0077, 0082, 0085], mouthpiece exhaust 164 through which exhaled breath can exit the device; a vessel exhaust outlet 328; a breath passageway from the mouthpiece 162 to the mouthpiece housing breath outlet port 166 and from the mouthpiece housing exhaust inlet port 168 to the mouthpiece exhaust 164). Dr. Moschos further discloses a dividing member 128 divides the mouthpiece inner component 120 and defines a boundary of the mouthpiece first chamber 130 (and second chamber) (paragraph [0074]). Dr Moschos does not disclose a one-way outlet valve; an air inlet 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; an air diverter, in the sample delivery part, arranged to divide the sample delivery part into an upstream portion and a downstream portion; the sample collection chamber comprising a liquid capture interface; and wherein the breath sampler is configured so that, during operation, the breath from the patient 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.
In a similar technical field, Pan discloses a one-way outlet valve arranged to allow air to exit the non-rebreather part (figure 2, paragraph [0063],  check valve 123 disposed in the collection branch 109 permits the breath sample to flow through the branch and into the container 117); an air inlet 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 (figure 2, paragraph [0063], check valve 115 permits air to be taken in through the intake end 113, but does not permit the subject's breath to pass out through the intake end); the sample collection chamber comprising a liquid capture interface(paragraph [0065], the container 117 of the detection unit 105 is constructed for holding a volume of liquid L; diffusion of the breath sample by the head 125 facilitates retention of any ammonia in the sample by the liquid L); and wherein the breath sampler is configured so that, during operation, the breath from the patient 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 (paragraph [0065], the container 117 of the detection unit 105 is constructed for holding a volume of liquid L; diffusion of the breath sample by the head 125 facilitates retention of any ammonia in the sample by the liquid L).
In a similar technical field, Sherwood discloses an air diverter, in the sample delivery part, arranged to divide the sample delivery part into an upstream portion and a downstream portion (paragraph [0086], gas sampling device 1010 has a diverter valve 1050 (or other component) that is configured to selectively route exhaled air to the exhaust port 1054 and the gas testing chamber 1026).
It would have been obvious to one of ordinary skill It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the breath sampler further comprises a one-way outlet valve arranged to allow air to exit the non-rebreather part; an air inlet  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; an air diverter, in the sample delivery part, arranged to divide the sample delivery part into an upstream portion and a downstream portion; the sample collection chamber comprising a liquid capture interface; and wherein the breath sampler is configured so that, during operation, the breath from the patient 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 as disclosed by Pan as such a modification would have been predictable, namely incorporating the check valve 115 of Pan into the mouthpiece breath inlet tube 132 of Dr Moschos to permit air to be taken in through the intake end, but does not permit the subject's breath to pass out through the intake end (Pan, paragraph [0063]), incorporating the check valves 123 of Pan into the mouthpiece breath outlet port 124 of Dr Moschos such that that the orientation of the check valve 123 is reversed to permit the breath sample to flow outwardly from the mouthpiece end through the tube, sample collection branch, container and vent, and to block air flow through the vent, sample collection branch, container and tube toward the mouthpiece end (Pan, paragraph [0064]), substituting the wall of Dr Moschos for the diverter valve of Sherwood to selectively route air (Sherwood, paragraph [0086]) and incorporating the liquid L of Pan into the collection vessel 300 of Dr Moschos to  facilitate the retention of any ammonia in the sample by the liquid L (Pan, paragraph [0065]). Further upon the modification of Dr Moschos to incorporate the liquid L of pan into the collection vessel 300 of Dr Moschos, Dr Moschos further discloses wherein the breath sampler is configured so that, during operation, the breath 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 chambers 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.
Regarding claim 2, upon the modification of Dr Moschos to incorporate the liquid of Pan into the collection vessel 300, as described with respect to claim 1 above, Dr Moschos further discloses 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 (paragraph [0074], mouthpiece breath inlet port 122 and mouthpiece breath outlet tube 134 providing a breath passageway from within the mouthpiece first chamber 130 to the mouthpiece breath outlet port 124), and wherein the sample delivery tube is removably connected to the sample outlet (figure 2b, paragraph [0075], second inner component 123 is removable from the first inner component 121 of the mouthpiece inner component 120 for cleaning of the saliva trap formed therein).
Regarding claim 3, Dr Moschos discloses the breath sampler according to claim 2 and a vessel breath tube 330 which extends within the phial 302 (paragraph [0082]). Dr Moschos does not disclose 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.
In a similar technical field, Pan discloses a diffuser coupled to the sample delivery tube (paragraph [0065], sample connection branch 109 which includes a diffuser head 125 is immersed in the liquid), the diffuser comprising an inlet (sample connection branch 109 including diffuser head 125) and a network of channels to divide the breath sample from the inlet into a plurality of streams (paragraph [0065], small openings 126 in the diffuser head 125; diffusion of the breath sample by the head 125 facilitates retention of any ammonia in the sample by the liquid L).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the breath sampler further comprises 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 as disclosed by Pan, as such a modification would have been predictable, namely incorporating the diffuser head 125 having small openings 126 of Pan onto the vessel breath tube 330 of Dr Moschos such that the head 125 facilitates retention of any ammonia in the sample by the liquid L (Pan, paragraph [0065]).
Regarding claim 4, Dr Moschos further discloses the breath sampler according to 1, wherein the air diverter comprises a wall extending in a plane that is transverse to the longitudinal axis of the sample delivery part (figure 2b, annotated figure 1A, paragraph [0074], dividing member 128 divides the mouthpiece inner component 120 and defines a boundary of the mouthpiece first chamber 130 and second chamber).
Regarding claim 10, Dr Moschos further discloses the breath sampler according to claim 1, further comprising a plurality of selectively connectable modules (figures 2b and 6, paragraphs [0075, 0078], first inner component 121 further comprises two connection members 125 arranged to slidably engage with corresponding connection members 127 provided on the second inner component 123; connecting protrusion 202 on each side of the collection vessel housing 200 into the two recess connection members 170).
Regarding claim 11, upon the modification of Dr Moschos to incorporate the check valves 115 and 123 of Pan, as described with respect to claim 1 above, Dr Moschos further discloses the breath sampler according to claim 10, wherein: a first module comprises the non-rebreather, the one-way outlet valve and the one-way air inlet part (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).
Regarding claim 14, Dr Moschos further discloses the breath sampler according to claim 1. Dr Moschos does not disclose wherein the sample collection chamber further comprises an integrated testing module.
In a similar technical field, Pan discloses wherein the sample collection chamber further comprises an integrated testing module (figure 3, paragraphs [0066, 0068], optical reader 131/231; may be of the type which sends light signals toward the membrane 127 so that a photo-detector (not shown) may read the color of the membrane. The optical reader 131 has a display 137 to output a suitable message indicative of the presence or absence of ammonia in the sampled breath based on the color of the membrane 127 detected).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the sample collection chamber further comprises an integrated testing module as disclosed by Pan, as such a modification would have been predictable, namely incorporating the optical reader of Pan into the collection vessel housing 200 having collection vessel 300 of Dr Moschos and incorporating the ammonia sensing membrane 127 into the collection vessel 300  of Dr Moschos such that the optical reader sends light signals toward the membrane so that a photo-detector may read the color of the membrane and output a suitable message indicative of the presence or absence of ammonia in the sampled breath based on the color of the membrane detected (Pan, paragraph [0067]).
Claims 5 is rejected under 35 U.S.C. 103 as being unpatentable over Dr Moschos in view of Pan, further in view of Sherwood, as applied to claim 1 above, and further in view of Dompeling et al. (US 20100292601 A1) (herein Dompeling).
Regarding claim 5, Dr Moschos further discloses the breath sampler according to claim 1. Dr Moschos does not disclose a volumetric breath quantifier configured to measure a volume of breath delivered to the sample outlet.
In a similar technical field, Dompeling discloses a volumetric breath quantifier (paragraph [0037], flow meter 14) configured to measure a volume of breath delivered to the sample outlet (paragraph [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 one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the breath sampler further comprises a volumetric breath quantifier configured to measure a volume of breath delivered to the sample outlet as disclosed by Dompeling as such a modification would have been predictable, namely incorporating the flow meter of Dompeling into the mouthpiece module 100 of Dr Moschos to calculate the amount of breath exhaled and hence the amount of breath collected in the gas container (Dompeling, paragraph [0037).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Dr Moschos in view of Pan, further in view of Sherwood, further in view of Dompeling, as applied to claim 5 above, and further in view of King-Smith (US 20170035326 A1).
Regarding claim 6, Dr Moschos, as modified to incorporate the volumetric breath quantifier, further discloses the breath sampler according to claim 5. Dr Moschos does not disclose wherein the volumetric breath quantifier is configured to separate the breath sample into at least two sub-samples.
In a similar technical field, King-Smith directed to device for capturing and concentrating volatile organic compounds (VOCs) in a sample of breath air, discloses wherein the volumetric breath quantifier is configured to separate the breath sample into at least two sub-samples (figure 6, paragraphs [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 one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the volumetric breath quantifier is configured to separate the breath sample into at least two sub-samples as disclosed by King-Smith as such a modification would have been predictable, namely incorporating the multiple compartments 714 of King-Smith into the collection vessel 300 of Dr Moschos 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, paragraphs [0116-0117).
Regarding claim 7, Dr Moschos further discloses the breath sampler according to claim 6, wherein the volumetric breath sampler further comprises a closure member (paragraph [0082], cap 320 comprises a sealing mechanism in the form of a sliding lid 322 arranged to seal a vessel breath inlet 326 and a vessel exhaust outlet 328 when the lid is closed; sliding lid 322 is provided with a lip 324 operable to move the sliding lid 322 into or out of position; when the sliding lid 322 is open, the vessel breath inlet 326 and the vessel exhaust outlet 328 are accessible). Dr Moschos does not disclose wherein the volumetric breath sampler 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 a similar technical field, King-smith discloses wherein the volumetric breath sampler further comprises a closure member (paragraph [0095], Ionic Liquid Collector 710 may have a sealing mechanism that is automatically opened and closed by the Concentrator 600) configured to selectively close the sample outlet to prevent a first sub-sample being delivered to the sample collection chamber (paragraphs [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 one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the volumetric breath sampler 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 as disclosed by King-Smith as such a modification would have been predictable, namely 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, paragraphs [0095, 0118, 0131]).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Dr Moschos in view of Pan, further in view of Sherwood, further in view of Dompeling, further in view of King-Smith, as applied to claim 7 above, further in view of Ahmad et al. (US 20170119280 A1) (herein Ahmad), and further in view of Akouka et al. (WO 2018071441 A1) (herein Akouka).
Regarding claim 8, Dr Moschos further discloses the breath sampler according to claim 7. Dr Moschos does not 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.
In a similar technical field, Ahmad directed to a breath capture device for determining the concentration of acetone in a breath sample from a user, 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, paragraphs [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).
In a similar technical field, 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, paragraph [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 one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that 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 as disclosed by Ahmad and Akouka as such a modification would have been predictable, namely 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, merely substituting the gear of Ahmad for the Geneva gear of Akouka, and manipulating the gear to provide variations in between the open and closed scenario (Ahmad, paragraphs [0320-0323).
Regarding claim 9, Dr Moschos further discloses the breath sampler according to claim 8. Dr Moschos does not 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.
In a similar technical field, Ahmad discloses wherein the volumetric breath quantifier is positioned downstream of the outlet valve (figures 70-71, paragraphs [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, paragraphs [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, paragraphs [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, paragraphs [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).
In a similar technical field, 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, paragraph [0200], Geneva drive 1000).
In a similar technical field, King-Smith discloses opening the closure member to allow a second sub-sample to be delivered to the sample collection chamber (paragraphs [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 one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that 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 as disclosed by Ahmad, Akouka, and King-Smith as such a modification would have been predictable, namely 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, merely substituting the gear of Ahmad for the Geneva gear of Akouka, and manipulating the gear to provide variations in between the open and closed scenario (Ahmad, paragraphs [0320-0323) such that Ionic Liquids that are preferential to the adsorption of particular VOCs are selected 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, paragraphs [0095, 0118, 0131]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Dr Moschos in view of Pan, further in view of Sherwood, as applied to claim 1 above, and further in view of Eichler (US 20160338616 A1).
Regarding claim 13, Dr Moschos further discloses the breath sampler according to claim 1. Dr Moschos does not disclose a delivery port in fluid communication with the non- rebreather part, configured for connection to a nebuliser.
In a similar technical field, Eichler directed to a medical apparatus for determining constituents of expiration volume discloses a delivery port in fluid communication with the non- rebreather part, configured for connection to a nebuliser (figure 2, paragraph [0103], liquid dispensing device 17 is a nebulizer, which via a separate air inlet suctions in filtered ambient air by means of a pump 20 triggered by the control unit 12, and adds to this the liquid for generating an aerosol mist; into the air distributor 1 in the direction of flow in front of the through-flow sensor 6; and the tempering of the through-flow sensor 6 through humidification can thus be conducted as a separate method step).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the breath sampler further comprises a delivery port in fluid communication with the non- rebreather part, configured for connection to a nebuliser as disclosed by Eichler, as such a modification would have been predictable, namely 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 Dr Moschos in view of Pan, further in view of Sherwood, as applied to claim 14 above, and further in view of Meka et al. (US 20070173731 A1) (herein Meka).
Regarding claim 15, Dr Moschos, as modified with respect to claim 14, further discloses the breath sampler according to claim 14.  Dr Moschos does not disclose wherein the integrated testing module is a lab-on-chip device.
In a similar technical field, Meka directed to a system for collecting an exhaled breath sample and exhaled breath aerosol from a subject discloses (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 one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the integrated testing module is a lab-on-chip device as disclosed by Meka, as such a modification would have been predictable, namely incorporating the miniaturized analysis chip of Meka into the collection vessel housing 200 having collection vessel 300 of Dr Moschos 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 Dr Moschos in view of Pan, further in view of Sherwood, as applied to claim 14 above, and further in view of Ku et al. (US 20120004571 A1) (herein Ku).
Regarding claim 16, Dr Moschos further discloses the breath sampler according to claim 14. Dr Moschos does not disclose wherein the integrated testing module comprises a PCR unit.
In a similar technical field, Ku directed to a device for collecting material from lung aerosols discloses wherein the integrated testing module comprises a PCR unit (paragraphs [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).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the integrated testing module comprises a PCR unit as disclosed by Ku as such a modification would have been predictable, namely 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 (paragraphs [0064, 0070]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable Dr Moschos in view of Pan, further in view of Sherwood, as applied to claim 1 above, further in view of Eichler and further in view of Lui et al. (US 20150072889 A1) (herein Lui)
Regarding claim 17, Dr Moschos further discloses the breath sampler according to claim 1. Dr Moschos 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.
In a similar technical field, 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”).
In a similar technical field, 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 one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that 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 as disclosed by Eichler and Lui, as such a modification would have been predictable, namely incorporating the sensor of Eichler to detect disease markers or inflammation markers selected from nucleic acid disease markers, cytokines, C-reactive proteins, chemokines, to detect pathogen-identifying material (Lui, paragraphs [0032, 0043, 0028, 0368]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Dr Moschos in view of Pan, further in view of Sherwood, as applied to claim 14 above, and further in view of Phillips (US 5465728 A).
Regarding claim 18, Dr Moschos further discloses the breath sampler according to claim 1. Dr Moschos does not disclose wherein the exhaust comprises a filter or mesh.
In a similar technical field, Pan discloses a filter or mesh (paragraph [0043], that the device can further contain a microbead layer, where microbeads can desirably attach to the desired ammonia, thereby preventing it from escaping as a vapor through the gas permeable filter)
In a similar technical field, 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).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the exhaust comprises a filter or mesh as disclosed by Phillips, as such a modification would have been predictable, namely incorporating the microorganism filter of Phillips into the exhaust of Dr Moschos to trap microorganisms such that the microorganism filter of Phillips prevents microorganisms from escaping the permeable filter (Phillips, column 6 lines 47-48 and Pan, paragraph [0043]).
Claim 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Dr Moschos in view of Pan, further in view of Sherwood, as applied to claim 14 above, and further in view of Kline (US 20040138577 A1).
Regarding claim 19, Dr Moschos further discloses the breath sampler according to claim 1. Dr Moschos 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.
In a similar technical field, Kline directed to a breath condensate collection apparatus, 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 one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the breath sampler further comprises 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 as disclosed by Kline, as such a modification would have been predictable, namely substituting the exhaust 164 of Dr Moschos for the removable 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 20, Dr Moschos further discloses the breath sampler according to claim 19. Dr Moschos does not disclose the breath sampler according to claim 19, wherein the sampler cap is arranged to cover the exhaust.
In a similar technical field, Kline discloses wherein the sampler cap is arranged to cover the exhaust (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 one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the sampler cap is arranged to cover the exhaust as disclosed by Kline, as such a modification would have been predictable, namely substituting the exhaust 164 of Dr Moschos for the removable 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, Dr Moschos further discloses the breath sampler according to claim 19. Dr Moschos does not disclose wherein the sampler cap comprises connection means corresponding to the sample collection chamber.
In a similar technical field, 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 one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that 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 substituting the exhaust 164 of Dr Moschos for the removable 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 consideration of this application is respectfully requested in view of the above amendments and the following remarks.
By this Amendment, claims 1 and 7 have been amended. No claims have been added or cancelled. Claims 1-11 and 13-21 are thus currently pending in this application, with claim 1 being the only independent claim. Support for the amendments can be found, for example, in Figs. 6E and 6F and in paragraph [0097] of the published description. No new matter is added.
Rej
ection under 35 U.S.C.
§
Claims 1-11 and 13-21 stand rejected under 35 U.S.C. § 112(b) as allegedly being indefinite for failing to particularly point out and distinctly claim the subject matter regarded as the invention, mainly for a lack of antecedence of claim term(s).
Claim 1 has been amended as provided herewith to clarify that "the breath from the patient" is --the breath sample from the patient--, as suggested by the examiner, and thereby rendering the rejection moot.
Reconsideration and withdrawal of the rejection is respectfully requested.
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 and U.S. Patent Application Publication No. 2018/0110444 to Sherwood et al.
Further, claim 5 stands rejected under 35 U.S.C. § 103 as allegedly being unpatentable over Dr Moschos in view of Pan, Sherwood, 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, 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, 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, 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, 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, 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, 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, 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, and U.S. Patent Application Publication No. 2004/0138577 to Kline.
The rejections are respectfully traversed for at least the following reasons.
Independent claim 1 has been amended as provided herewith to recite, in combination with other features, a non-rebreather part that comprises 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 in fluid communication with the first portion of the internal breath flow pathway. This combination of features is neither known nor derivable from the cited references.
Dr Moschos concerns an exhaled breath condensate collection device. The device includes a mouthpiece inner component (120) that comprises a first inner component (121) and a second inner component (123). The mouthpiece inner component is fully seated within a mouthpiece housing component (160) and the mouthpiece breath inlet port (122) and the mouthpiece exhaust outlet port are said to be aligned with the mouthpiece (162) and the mouthpiece exhaust (164). Dr Moschos admittedly does not disclose or suggest a non-rebreather part comprising a one-way outlet valve and an air inlet. The Official Action, therefore, cites Pan to supposedly remedy this deficiency (See Official Action, page 10).
Pan generally relates to a method and apparatus to detect the presence of bacteria in a subject. Pan provides a check valve (115) near the intake end (113) of the tube (107) that restricts flow through the tube at the intake end to a direction toward the mouthpiece end (111) and blocks flow out of the intake end (see Pan at para. [0063] and Fig. 2). However, Pan fails to disclose or suggest slits or openings of any kind in the any of the check valve, intake end, or the tube.
Sherwood was also cited by the Official Action to reject independent claim 1, but solely to teach an air diverter in the sample delivery part arranged to divide the sample delivery part into an upstream portion and a downstream portion. Sherwood lacks any teaching or reasonable suggestion of the recited air inlet comprising a plurality of slits in a wall of the breath sampler, and as such, cannot be applied to cure the aforementioned deficiencies of Dr Moschos and Pan.
Accordingly, it is respectfully submitted that Dr Moschos, Pan, and Sherwood, whether taken individually or in combination, fail to disclose, reasonably suggest, or render obvious a breath sampler having all the features of the amended claim 1.
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 inlet comprising a plurality of slits in a wall of the breath sampler. 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, and Sherwood.
For at least the reasons discussed herein, it is respectfully submitted that the disclosures in Dr Moschos, Pan, Sherwood, 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 the amended 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 .
Amendment Entered
In response to the amendment filed on April 27th, 2024, amended claims 1-11 and 13-21 remain pending in the application.
Response to Arguments
Applicant’s remarks and amendments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections under 35 U.S.C. 112(b) are withdrawn in view of the amendment.
Applicant’s arguments with respect to claims 1-12 and 13-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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: “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 as a wall (page 13 line 28); 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 1-4, 10-11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Dr Moschos (US 20210093226 A1) in view of Pan (US 20040077093 A1), further in view of Sherwood (US 20180110444 A1), and further in view of Yadidi (US 10195147 B1).
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Annotated figures 1A and 11 of Dr Moschos
Regarding claim 1, Dr Moschos discloses a breath sampler for collecting a breath sample from a patient, the breath sampler (figure 13, paragraphs [0001, 0086], an exhaled breath condensate collection device; mouthpiece module 100 and collection vessel housing 200) comprising: a non-rebreather part (figure 13, paragraph [0086], mouthpiece module 100) comprising: a sample inlet (figure 1, paragraph [0074], a mouthpiece breath inlet port 122 and mouthpiece breath inlet tube 132); an outlet arranged to allow air to exit the non-rebreather part (figure 1a, mouthpiece breath outlet tube 134) the outlet and the sample inlet defining a first portion of an internal breath flow pathway therebetween (figure 1a, paragraph [0074], mouthpiece first chamber 130; mouthpiece breath inlet tube 132 and mouthpiece breath outlet tube 134 providing a breath passageway from within the mouthpiece first chamber 130); and a sample delivery part in fluid communication with the non-rebreather part at an upstream end via the outlet (annotated figure 1a,  paragraph [0090], collection vessel has a vessel breath inlet (326) for admitting exhaled breath into the chamber; and in fluid communication with the mouthpiece breath outlet port (124))), the sample delivery part defining a second portion of the internal breath flow pathway (annotated figure 1A, second chamber), the sample delivery part (annotated figure 1A, paragraphs [0074, 0090], second chamber having mouthpiece breath outlet port 124 in fluid communication with vessel breath inlet 326, and mouthpiece exhaust tube 138) comprising: a sample outlet in the upstream portion (figure 1a, paragraphs [0074, 0082], mouthpiece breath outlet tube 134 and mouthpiece breath outlet port 124; vessel breath tube 330); a return inlet in the downstream portion and in fluid communication with an exhaust (figure 4, paragraphs [0074, 0077, 0082, 0087], mouthpiece exhaust inlet port 136; a mouthpiece exhaust outlet port 140 at a downstream end; vessel exhaust tube 332; and mouthpiece exhaust 164 through which exhaled breath can exit the device); and a sample collection chamber connector (paragraphs [0086], recess connection members 170) configured to form a seal with an opening of a sample collection chamber (figures 10 and 13-14, paragraphs [0086-0087], collection vessel housing 200 is typically attached to the mouthpiece module 100 whilst the mouthpiece is in the sealed configuration; lip 324 acts to withdraw the sliding lid 322 whereby to expose the sealing film (not shown) covering the openings of the vessel breath inlet 326 and the vessel exhaust outlet 328), the connector defining a perimeter (annotated figure 11, paragraph [0086], recess connection members 170 having a perimeter), the sample outlet and the return inlet being disposed within the perimeter (annotated figure 11, paragraphs [0085- 0086], recess connection members 170 having a perimeter having mouthpiece exhaust inlet port 136 and mouthpiece breath outlet port 124), wherein the breath sampler further comprises the sample collection chamber coupled to the sample collection chamber connector (figure 14, paragraphs [0086-0087], collection vessel housing 200 is mounted to the mouthpiece module 100; collection vessel 300 is inserted into the collection vessel housing 200 through the collection vessel receiving opening 206), wherein the breath sampler is configured so that, during operation, the breath from the patient passes through the non-rebreather part (paragraph [0074], first chamber 130; mouthpiece breath inlet port 122 configured to receive exhaled breath from a subject and a mouthpiece breath outlet port 124 arranged to be in fluid communication with the mouthpiece breath inlet port 122 to form a breath passageway and to output exhaled breath out of the mouthpiece module 100), is delivered via the sample delivery part to the sample outlet into the sample collection chamber (paragraph [0090], fluid conduction from a mouthpiece breath inlet port (122) for receiving exhaled breath to a mouthpiece breath outlet port (124); and collection vessel (300) defines a sealed and resealable chamber for collecting exhaled breath condensate in use; having breath inlet (326) for admitting exhaled breath into the chamber, 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 (paragraphs [0077, 0082, 0085], mouthpiece exhaust 164 through which exhaled breath can exit the device; a vessel exhaust outlet 328; a breath passageway from the mouthpiece 162 to the mouthpiece housing breath outlet port 166 and from the mouthpiece housing exhaust inlet port 168 to the mouthpiece exhaust 164). Dr. Moschos further discloses a dividing member 128 divides the mouthpiece inner component 120 and defines a boundary of the mouthpiece first chamber 130 (and second chamber) (paragraph [0074]). Dr Moschos does not disclose a one-way outlet valve; 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; an air diverter, in the sample delivery part, arranged to divide the sample delivery part into an upstream portion and a downstream portion; the sample collection chamber comprising a liquid capture interface; and wherein the breath sampler is configured so that, during operation, the breath from the patient 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.
In a similar technical field, Pan discloses a one-way outlet valve arranged to allow air to exit the non-rebreather part (figure 2, paragraph [0063],  check valve 123 disposed in the collection branch 109 permits the breath sample to flow through the branch and into the container 117); an air inlet 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 (figure 2, paragraph [0063], check valve 115 permits air to be taken in through the intake end 113, but does not permit the subject's breath to pass out through the intake end); the sample collection chamber comprising a liquid capture interface(paragraph [0065], the container 117 of the detection unit 105 is constructed for holding a volume of liquid L; diffusion of the breath sample by the head 125 facilitates retention of any ammonia in the sample by the liquid L); and wherein the breath sampler is configured so that, during operation, the breath from the patient 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 (paragraph [0065], the container 117 of the detection unit 105 is constructed for holding a volume of liquid L; diffusion of the breath sample by the head 125 facilitates retention of any ammonia in the sample by the liquid L).
In a similar technical field, Sherwood discloses an air diverter, in the sample delivery part, arranged to divide the sample delivery part into an upstream portion and a downstream portion (paragraphs [0086], gas sampling device 1010 has a diverter valve 1050 (or other component) that is configured to selectively route exhaled air to the exhaust port 1054 and the gas testing chamber 1026).
In a similar technical field, Yadidi directed to apparatuses and methods for delivery of API to the lungs by inhalation for treating disease (column 1 lines 19-21); (see page 4 lines 30-33 of the instant application specification “breath sampler can further comprise a delivery port in fluid communication with the first conduit. The delivery port be configured for connection to a nebuliser for delivering an inhaled medicament to the user”); discloses an air inlet comprising a plurality of slits in a wall of the breath sampler (column 7 lines 10-11 & 42-45, housing 105 defining a chamber 110 having one or more air inlets 115; inlets 115 may comprise a plurality of tangentially oriented slots 220. When a user inhales through the endpiece 210, outside air is caused to flow through the inlets 115 (e.g., tangential slots 220)).
It would have been obvious to one of ordinary skill It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the breath sampler further comprises a one-way outlet valve arranged to allow air to exit the non-rebreather part; an air inlet comprising a plurality of slits in a wall of the breath sampler as disclosed by Yadidi 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 as disclosed by Pan; an air diverter, in the sample delivery part, arranged to divide the sample delivery part into an upstream portion and a downstream portion as disclosed by Sherwood; the sample collection chamber comprising a liquid capture interface; and wherein the breath sampler is configured so that, during operation, the breath from the patient 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 as disclosed by Pan as such a modification would have been predictable, namely incorporating the air inlets comprising a plurality of tangentially oriented slots of Yadidi and the check valve 115 of Pan into the exhaled breath condensate collection device of Dr Moschos such that outside air is caused to flow through the inlets (Yadidi, column 7 lines 10-11 & 42-45), but does not permit the subject's breath to pass out through the intake end (Pan, paragraph [0063]), incorporating the check valves 123 of Pan into the mouthpiece breath outlet port 124 of Dr Moschos such that that the orientation of the check valve 123 is reversed to permit the breath sample to flow outwardly from the mouthpiece end through the tube, sample collection branch, container and vent, and to block air flow through the vent, sample collection branch, container and tube toward the mouthpiece end (Pan, paragraph [0064]), substituting the wall of Dr Moschos for the diverter valve of Sherwood to selectively route air (Sherwood, paragraph [0086]) and incorporating the liquid L of Pan into the collection vessel 300 of Dr Moschos to  facilitate the retention of any ammonia in the sample by the liquid L (Pan, paragraph [0065]). Further upon the modification of Dr Moschos to incorporate the liquid L of pan into the collection vessel 300 of Dr Moschos, Dr Moschos further discloses wherein the breath sampler is configured so that, during operation, the breath 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 chambers 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.
Regarding claim 2, upon the modification of Dr Moschos to incorporate the liquid of Pan into the collection vessel 300, as described with respect to claim 1 above, Dr Moschos further discloses 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 (paragraph [0074], mouthpiece breath inlet port 122 and mouthpiece breath outlet tube 134 providing a breath passageway from within the mouthpiece first chamber 130 to the mouthpiece breath outlet port 124), and wherein the sample delivery tube is removably connected to the sample outlet (figure 2b, paragraph [0075], second inner component 123 is removable from the first inner component 121 of the mouthpiece inner component 120 for cleaning of the saliva trap formed therein).
Regarding claim 3, Dr Moschos discloses the breath sampler according to claim 2 and a vessel breath tube 330 which extends within the phial 302 (paragraph [0082]). Dr Moschos does not disclose 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.
In a similar technical field, Pan discloses a diffuser coupled to the sample delivery tube (paragraph [0065], sample connection branch 109 which includes a diffuser head 125 is immersed in the liquid), the diffuser comprising an inlet (sample connection branch 109 including diffuser head 125) and a network of channels to divide the breath sample from the inlet into a plurality of streams (paragraph [0065], small openings 126 in the diffuser head 125; diffusion of the breath sample by the head 125 facilitates retention of any ammonia in the sample by the liquid L).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the breath sampler further comprises 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 as disclosed by Pan, as such a modification would have been predictable, namely incorporating the diffuser head 125 having small openings 126 of Pan onto the vessel breath tube 330 of Dr Moschos such that the head 125 facilitates retention of any ammonia in the sample by the liquid L (Pan, paragraph [0065]).
Regarding claim 4, Dr Moschos further discloses the breath sampler according to 1, wherein the air diverter comprises a wall extending in a plane that is transverse to the longitudinal axis of the sample delivery part (figure 2b, annotated figure 1A, paragraph [0074], dividing member 128 divides the mouthpiece inner component 120 and defines a boundary of the mouthpiece first chamber 130 and second chamber).
Regarding claim 10, Dr Moschos further discloses the breath sampler according to claim 1, further comprising a plurality of selectively connectable modules (figures 2b and 6, paragraphs [0075, 0078], first inner component 121 further comprises two connection members 125 arranged to slidably engage with corresponding connection members 127 provided on the second inner component 123; connecting protrusion 202 on each side of the collection vessel housing 200 into the two recess connection members 170).
Regarding claim 11, upon the modification of Dr Moschos to incorporate the check valves 115 and 123 of Pan, as described with respect to claim 1 above, Dr Moschos further discloses the breath sampler according to claim 10, wherein: a first module comprises the non-rebreather, the one-way outlet valve and the one-way air inlet part (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).
Regarding claim 14, Dr Moschos further discloses the breath sampler according to claim 1. Dr Moschos does not disclose wherein the sample collection chamber further comprises an integrated testing module.
In a similar technical field, Pan discloses wherein the sample collection chamber further comprises an integrated testing module (figure 3, paragraphs [0066, 0068], optical reader 131/231; may be of the type which sends light signals toward the membrane 127 so that a photo-detector (not shown) may read the color of the membrane. The optical reader 131 has a display 137 to output a suitable message indicative of the presence or absence of ammonia in the sampled breath based on the color of the membrane 127 detected).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the sample collection chamber further comprises an integrated testing module as disclosed by Pan, as such a modification would have been predictable, namely incorporating the optical reader of Pan into the collection vessel housing 200 having collection vessel 300 of Dr Moschos and incorporating the ammonia sensing membrane 127 into the collection vessel 300  of Dr Moschos such that the optical reader sends light signals toward the membrane so that a photo-detector may read the color of the membrane and output a suitable message indicative of the presence or absence of ammonia in the sampled breath based on the color of the membrane detected (Pan, paragraph [0067]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Dr Moschos in view of Pan, further in view of Sherwood, further in view of Yadidi, as applied to claim 1 above, and further in view of Dompeling (US 20100292601 A1).
Regarding claim 5, Dr Moschos further discloses the breath sampler according to claim 1. Dr Moschos does not disclose a volumetric breath quantifier configured to measure a volume of breath delivered to the sample outlet.
In a similar technical field, Dompeling discloses a volumetric breath quantifier (paragraph [0037], flow meter 14) configured to measure a volume of breath delivered to the sample outlet (paragraph [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 one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the breath sampler further comprises a volumetric breath quantifier configured to measure a volume of breath delivered to the sample outlet as disclosed by Dompeling as such a modification would have been predictable, namely incorporating the flow meter of Dompeling into the mouthpiece module 100 of Dr Moschos to calculate the amount of breath exhaled and hence the amount of breath collected in the gas container (Dompeling, paragraph [0037).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Dr Moschos in view of Pan, further in view of Sherwood, further in view of Yadidi, further in view of Dompeling, as applied to claim 5 above, and further in view of King-Smith (US 20170035326 A1).
Regarding claim 6, Dr Moschos, as modified to incorporate the volumetric breath quantifier, further discloses the breath sampler according to claim 5. Dr Moschos does not disclose wherein the volumetric breath quantifier is configured to separate the breath sample into at least two sub-samples.
In a similar technical field, King-Smith directed to device for capturing and concentrating volatile organic compounds (VOCs) in a sample of breath air, discloses wherein the volumetric breath quantifier is configured to separate the breath sample into at least two sub-samples (figure 6, paragraphs [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 one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the volumetric breath quantifier is configured to separate the breath sample into at least two sub-samples as disclosed by King-Smith as such a modification would have been predictable, namely incorporating the multiple compartments 714 of King-Smith into the collection vessel 300 of Dr Moschos 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, paragraphs [0116-0117).
Regarding claim 7, Dr Moschos further discloses the breath sampler according to claim 6, wherein the volumetric breath quantifier further comprises a closure member (paragraph [0082], cap 320 comprises a sealing mechanism in the form of a sliding lid 322 arranged to seal a vessel breath inlet 326 and a vessel exhaust outlet 328 when the lid is closed; sliding lid 322 is provided with a lip 324 operable to move the sliding lid 322 into or out of position; when the sliding lid 322 is open, the vessel breath inlet 326 and the vessel exhaust outlet 328 are accessible). Dr Moschos does not 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.
In a similar technical field, King-smith discloses wherein the volumetric breath quantifier further comprises a closure member (paragraph [0095], Ionic Liquid Collector 710 may have a sealing mechanism that is automatically opened and closed by the Concentrator 600) configured to selectively close the sample outlet to prevent a first sub-sample being delivered to the sample collection chamber (paragraphs [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 one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that 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 as disclosed by King-Smith as such a modification would have been predictable, namely 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, paragraphs [0095, 0118, 0131]).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Dr Moschos in view of Pan, further in view of Sherwood, further in view of Yadidi, 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, Dr Moschos further discloses the breath sampler according to claim 7. Dr Moschos does not 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.
In a similar technical field, Ahmad directed to a breath capture device for determining the concentration of acetone in a breath sample from a user, 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, paragraphs [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).
In a similar technical field, 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, paragraph [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 one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that 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 as disclosed by Ahmad and Akouka as such a modification would have been predictable, namely 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, merely substituting the gear of Ahmad for the Geneva gear of Akouka, and manipulating the gear to provide variations in between the open and closed scenario (Ahmad, paragraphs [0320-0323).
Regarding claim 9, Dr Moschos further discloses the breath sampler according to claim 8. Dr Moschos does not 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.
In a similar technical field, Ahmad discloses wherein the volumetric breath quantifier is positioned downstream of the outlet valve (figures 70-71, paragraphs [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, paragraphs [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, paragraphs [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, paragraphs [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).
In a similar technical field, 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, paragraph [0200], Geneva drive 1000).
In a similar technical field, King-Smith discloses opening the closure member to allow a second sub-sample to be delivered to the sample collection chamber (paragraphs [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 one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that 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 as disclosed by Ahmad, Akouka, and King-Smith as such a modification would have been predictable, namely 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, merely substituting the gear of Ahmad for the Geneva gear of Akouka, and manipulating the gear to provide variations in between the open and closed scenario (Ahmad, paragraphs [0320-0323) such that Ionic Liquids that are preferential to the adsorption of particular VOCs are selected 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, paragraphs [0095, 0118, 0131]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Dr Moschos in view of Pan, further in view of Sherwood, further in view of Yadidi, as applied to claim 1 above, and further in view of Eichler (US 20160338616 A1).
Regarding claim 13, Dr Moschos further discloses the breath sampler according to claim 1. Dr Moschos does not disclose a delivery port in fluid communication with the non- rebreather part, configured for connection to a nebuliser.
In a similar technical field, Eichler directed to a medical apparatus for determining constituents of expiration volume discloses a delivery port in fluid communication with the non- rebreather part, configured for connection to a nebuliser (figure 2, paragraph [0103], liquid dispensing device 17 is a nebulizer, which via a separate air inlet suctions in filtered ambient air by means of a pump 20 triggered by the control unit 12, and adds to this the liquid for generating an aerosol mist; into the air distributor 1 in the direction of flow in front of the through-flow sensor 6; and the tempering of the through-flow sensor 6 through humidification can thus be conducted as a separate method step).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the breath sampler further comprises a delivery port in fluid communication with the non- rebreather part, configured for connection to a nebuliser as disclosed by Eichler, as such a modification would have been predictable, namely 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 Dr Moschos in view of Pan, further in view of Sherwood, further in view of Yadidi, as applied to claim 14 above, and further in view of Meka (US 20070173731 A1).
Regarding claim 15, Dr Moschos, as modified with respect to claim 14, further discloses the breath sampler according to claim 14.  Dr Moschos does not disclose wherein the integrated testing module is a lab-on-chip device.
In a similar technical field, Meka directed to a system for collecting an exhaled breath sample and exhaled breath aerosol from a subject discloses (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 one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the integrated testing module is a lab-on-chip device as disclosed by Meka, as such a modification would have been predictable, namely incorporating the miniaturized analysis chip of Meka into the collection vessel housing 200 having collection vessel 300 of Dr Moschos 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 Dr Moschos in view of Pan, further in view of Sherwood, further in view of Yadidi, as applied to claim 14 above, and further in view of Ku (US 20120004571 A1).
Regarding claim 16, Dr Moschos further discloses the breath sampler according to claim 14. Dr Moschos does not disclose wherein the integrated testing module comprises a PCR unit.
In a similar technical field, Ku directed to a device for collecting material from lung aerosols discloses wherein the integrated testing module comprises a PCR unit (paragraphs [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).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the integrated testing module comprises a PCR unit as disclosed by Ku as such a modification would have been predictable, namely 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 (paragraphs [0064, 0070]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable Dr Moschos in view of Pan, further in view of Sherwood, further in view of Yadidi, as applied to claim 1 above, further in view of Eichler and further in view of Lui (US 20150072889 A1).
Regarding claim 17, Dr Moschos further discloses the breath sampler according to claim 1. Dr Moschos 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.
In a similar technical field, 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”).
In a similar technical field, 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 one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that 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 as disclosed by Eichler and Lui, as such a modification would have been predictable, namely incorporating the sensor of Eichler to detect disease markers or inflammation markers selected from nucleic acid disease markers, cytokines, C-reactive proteins, chemokines, to detect pathogen-identifying material (Lui, paragraphs [0032, 0043, 0028, 0368]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Dr Moschos in view of Pan, further in view of Sherwood, further in view of Yadidi, as applied to claim 14 above, and further in view of Phillips (US 5465728 A).
Regarding claim 18, Dr Moschos further discloses the breath sampler according to claim 1. Dr Moschos does not disclose wherein the exhaust comprises a filter or mesh.
In a similar technical field, Pan discloses a filter or mesh (paragraph [0043], that the device can further contain a microbead layer, where microbeads can desirably attach to the desired ammonia, thereby preventing it from escaping as a vapor through the gas permeable filter)
In a similar technical field, 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).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the exhaust comprises a filter or mesh as disclosed by Phillips, as such a modification would have been predictable, namely incorporating the microorganism filter of Phillips into the exhaust of Dr Moschos to trap microorganisms such that the microorganism filter of Phillips prevents microorganisms from escaping the permeable filter (Phillips, column 6 lines 47-48 and Pan, paragraph [0043]).
Claim 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Dr Moschos in view of Pan, further in view of Sherwood, further in view of Yadidi, as applied to claim 14 above, and further in view of Kline (US 20040138577 A1).
Regarding claim 19, Dr Moschos further discloses the breath sampler according to claim 1. Dr Moschos 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.
In a similar technical field, Kline directed to a breath condensate collection apparatus, 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 one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the breath sampler further comprises 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 as disclosed by Kline, as such a modification would have been predictable, namely substituting the exhaust 164 of Dr Moschos for the removable 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 20, Dr Moschos further discloses the breath sampler according to claim 19. Dr Moschos does not disclose the breath sampler according to claim 19, wherein the sampler cap is arranged to cover the exhaust.
In a similar technical field, Kline discloses wherein the sampler cap is arranged to cover the exhaust (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 one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that the sampler cap is arranged to cover the exhaust as disclosed by Kline, as such a modification would have been predictable, namely substituting the exhaust 164 of Dr Moschos for the removable 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, Dr Moschos further discloses the breath sampler according to claim 19. Dr Moschos does not disclose wherein the sampler cap comprises connection means corresponding to the sample collection chamber.
In a similar technical field, 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 one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dr Moschos such that 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 substituting the exhaust 164 of Dr Moschos for the removable 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's amendment necessitated the new ground(s) of rejection presented in this Office action.  Accordingly, THIS ACTION IS MADE FINAL.  See MPEP § 706.07(a).  Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action.  In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action.  In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.

CITED REFERENCE SUMMARIES: 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 configured to be user-operable to cause movement of the one or more moveable components to cause the collection vessel to become unsealed and in the sample collection configuration when in use.
The kit of claim 1 , wherein the collection vessel comprises a resealing mechanism configured to reseal the collection vessel as the collection vessel is removed from the assembly or at least from the one or more parts of the assembly in which the collection vessel is cooled in use.
The kit of claim 8 , in which the collection vessel and one or more other parts of the assembly are configured such that the resealing mechanism is configured to cooperate with the one or more other parts of the assembly to cause the collection vessel to be resealed.
The kit of claim 8 , wherein the resealing mechanism is biased towards a sealed configuration, and wherein the collection vessel and one or more other parts of the assembly are configured to: keep the resealing mechanism out of the sealed configuration when the collection vessel is inserted into the assembly for sample collection; and allow the resealing mechanism to return to the sealed configuration as the collection vessel is removed from the assembly.
keep the resealing mechanism out of the sealed configuration when the collection vessel is inserted into the assembly for sample collection; and
allow the resealing mechanism to return to the sealed configuration as the collection vessel is removed from the assembly.
The kit of claim 8 , wherein the resealing mechanism comprises a sliding lid which covers and seals at least the vessel breath inlet when the resealing mechanism is in a sealed configuration.
The kit of claim 11 , wherein the collection vessel and one or more other parts of the assembly are configured such that the sliding lid of the resealing mechanism is urged open upon insertion into the assembly.
The kit of claim 11 , wherein the collection vessel and one or more other parts of the assembly are configured such that the sliding lid of the resealing mechanism is urged shut upon removal from the assembly.
The kit of claim 11 , wherein a collection vessel housing configured for receiving the collection vessel for cooling during sample collection or the mouthpiece module is configured to engage with a lip of the sliding lid to cause the sliding lid to be urged open and/or shut.
The kit of claim 11 , wherein the sliding lid abuts in the resealing mechanism against a resilient sealing material configured to seal the collection vessel when the sliding lid is closed.
The kit of claim 15 , wherein the resealing mechanism is configured such that the sliding lid is urged against the resilient sealing material to reinforce the seal if there is an overpressure inside the collection vessel.
The kit of claim 1 , wherein the mouthpiece module further comprises a seal configured to prevent air from flowing in the breath passageway at least through the mouthpiece breath inlet port when not in use.
The kit of claim 1 , further comprising a cooling component configured to cool the collection vessel to a temperature below minus 60 degrees Celsius.
The kit of claim 1 , wherein the mouthpiece module further comprises a mouthpiece configured to be in fluid communication with the mouthpiece breath inlet port when in use.
The kit of claim 1 , wherein the mouthpiece module further comprises a saliva trap between the mouthpiece breath inlet port and the mouthpiece breath outlet port.
The kit of claim 1 , wherein the collection vessel is configured to be centrifuge resistant and shaped to cause exhaled breath condensate to collect at a bottom of the chamber during centrifuging.
The kit of claim 1 , wherein the collection vessel further comprises an extraction port for removal of the exhaled breath condensate from the collection vessel.
The kit of claim 22 , wherein the extraction port is coupleable to a syringe and wherein an overpressure in the collection vessel causes the exhaled breath condensate collected adjacent the extraction port to be ejected from the collection vessel and into the syringe.
A method, comprising: coupling a collection vessel to a mouthpiece module wherein the coupling causes cooling of the collection vessel; based on the coupling of the collection vessel to the mouthpiece module, unsealing the collection vessel such that a mouthpiece inlet port of the mouthpiece module is in fluid communication with a vessel breath inlet of the collection vessel such that the collection vessel is prepared to receive a sample; collecting exhaled breath condensate within a chamber of the collection vessel, wherein the chamber is coupled to the vessel breath inlet of the collection vessel; decoupling the collection vessel from the mouthpiece module; and based on the decoupling of the collection vessel from the mouthpiece module, resealing the collection vessel.
coupling a collection vessel to a mouthpiece module wherein the coupling causes cooling of the collection vessel;
based on the coupling of the collection vessel to the mouthpiece module, unsealing the collection vessel such that a mouthpiece inlet port of the mouthpiece module is in fluid communication with a vessel breath inlet of the collection vessel such that the collection vessel is prepared to receive a sample;
collecting exhaled breath condensate within a chamber of the collection vessel, wherein the chamber is coupled to the vessel breath inlet of the collection vessel;
decoupling the collection vessel from the mouthpiece module; and
based on the decoupling of the collection vessel from the mouthpiece module, resealing the collection vessel.
The method of claim 27 , further comprising: centrifuging the collection vessel to cause the exhaled breath condensate to collect at a bottom of the collection vessel; and extracting the collected exhaled breath condensate from the collection vessel through a port provided at the bottom of the collection vessel.
centrifuging the collection vessel to cause the exhaled breath condensate to collect at a bottom of the collection vessel; and
extracting the collected exhaled breath condensate from the collection vessel through a port provided at the bottom of the collection vessel.
The kit of claim 8 , wherein the collection vessel further comprises a sealed vessel exhaust outlet to emit collected breath in use, 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, and wherein the resealing mechanism comprises a sliding lid covers and seals at least the vessel breath inlet and the vessel exhaust outlet when the resealing mechanism is in a sealed configuration.
The kit of claim 12 , wherein the sliding lid of the resealing mechanism is urged open upon insertion into the assembly by a lip of the sliding lid that catches on the assembly.
The kit of claim 13 , wherein the sliding lid of the resealing mechanism is urged shut upon removal from the assembly by a lip of the sliding lid that catches on the assembly.
The kit of claim 22 , wherein the extraction port is arranged at a location of the chamber at which the exhaled breath condensate collects during centrifuging.
A device, comprising: a mouthpiece module, the mouthpiece module comprising: a mouthpiece breath inlet port; a mouthpiece breath outlet port; and a breath passageway that provides fluid communication between the mouthpiece breath inlet port and mouthpiece breath outlet port; and a collection vessel coupleable to the mouthpiece module and configured to cool a fluid within the device, the collection vessel comprising: a vessel breath inlet that is sealed closed until the collection vessel is coupled to the mouthpiece module, wherein when the collection vessel is coupled to the mouthpiece module the vessel breath inlet is in fluid connection with the mouthpiece breath outlet port, and further wherein the vessel breath inlet becomes resealed when the mouthpiece module is decoupled from the collection vessel; and a chamber that is configured to collect condensate from the fluid and is coupled to the vessel breath inlet.
a mouthpiece module, the mouthpiece module comprising: a mouthpiece breath inlet port; a mouthpiece breath outlet port; and a breath passageway that provides fluid communication between the mouthpiece breath inlet port and mouthpiece breath outlet port; and
a mouthpiece breath inlet port;
a mouthpiece breath outlet port; and
a breath passageway that provides fluid communication between the mouthpiece breath inlet port and mouthpiece breath outlet port; and
a collection vessel coupleable to the mouthpiece module and configured to cool a fluid within the device, the collection vessel comprising: a vessel breath inlet that is sealed closed until the collection vessel is coupled to the mouthpiece module, wherein when the collection vessel is coupled to the mouthpiece module the vessel breath inlet is in fluid connection with the mouthpiece breath outlet port, and further wherein the vessel breath inlet becomes resealed when the mouthpiece module is decoupled from the collection vessel; and
a vessel breath inlet that is sealed closed until the collection vessel is coupled to the mouthpiece module, wherein when the collection vessel is coupled to the mouthpiece module the vessel breath inlet is in fluid connection with the mouthpiece breath outlet port, and further wherein the vessel breath inlet becomes resealed when the mouthpiece module is decoupled from the collection vessel; and
a chamber that is configured to collect condensate from the fluid and is coupled to the vessel breath inlet.
Ref US20100292601A1: Claims:
- 15 . (canceled)
A breath condensing apparatus, the apparatus comprising: a mouthpiece, a condenser having an inlet in fluid communication with the mouthpiece, a first container for collecting condensate in fluid communication with an outlet of the condenser, and a second container for collecting residual, non-condensed exhaled breath in fluid communication with the condenser.
a condenser having an inlet in fluid communication with the mouthpiece,
a first container for collecting condensate in fluid communication with an outlet of the condenser, and
a second container for collecting residual, non-condensed exhaled breath in fluid communication with the condenser.
The apparatus according to claim 16 , wherein the second container is a collapsible bag made of a flexible, thin-walled material.
The apparatus according to claim 17 , wherein the flexible, thin-walled material comprises a film of an inert synthetic material.
The apparatus according to claim 16 , wherein the second container is connected to both the inlet and the outlet of the condenser thus enabling recirculation of breath collected in the second container through the condenser.
The apparatus according to claim 16 , wherein the second container has a volume of between approximately 10 liters and approximately 100 liters.
The apparatus according to claim 16 , further comprising one or more heating elements for maintaining residual, non-condensed exhaled breath gaseous and at a temperature of between approximately 30° C. and approximately 42° C.
The apparatus according to claim 21 , further comprising a casing, wherein the second container and the heating elements are disposed inside the casing.
The apparatus according to claim 16 , further comprising a wiper positionable inside the condenser to wipe condensate from the inner wall of the condenser and towards the first container for collecting condensate.
The apparatus according to claim 16 , further comprising one or more channels located at or below the inlet and having both a tangential and an axial component, relative to the central axis of the condenser, to direct exhaled breath towards the inner wall of the tube.
The apparatus according to claim 16 , wherein at least one of the mouthpiece or a duct connecting the mouthpiece to the condenser comprises one of: a two-way non-rebreathing valve system, a flow meter, and a saliva-trap.
a two-way non-rebreathing valve system,
a flow meter, and
The apparatus according to claim 16 , further comprising a sensor for measuring the relative humidity of the contents of the second container.
The apparatus according to claim 16 , further comprising a ventilator adapted to force recirculation of non-condensed exhaled breath.
A method of condensing exhaled breath, the method comprising: receiving exhaled breath from a subject into a condenser, condensing at least part of the exhaled breath, collecting at least part of residual, non-condensed exhaled breath, recirculating at least part of the collected residual breath through the condenser, condensing at least part of the recirculated breath, and collecting condensate.
receiving exhaled breath from a subject into a condenser,
condensing at least part of the exhaled breath,
collecting at least part of residual, non-condensed exhaled breath,
recirculating at least part of the collected residual breath through the condenser,
condensing at least part of the recirculated breath, and
collecting condensate.
The method according to claim 28 , further comprising collecting the residual, non-condensed air in a collapsible bag.
The method according to claim 29 , wherein the bag is collapsed when exhaled breath is received into the condenser.
The method according to claim 28 , further comprising heating the residual, non-condensed exhaled breath to a temperature of between approximately 30° C. and 42° C.
The method of claim 28 , wherein condensing at least part of the exhaled breath comprises condensing at least 10 liters of the exhaled breath.
The method of claim 28 , the condenser comprising a first condenser and a second condenser, wherein receiving exhaled breath into a condenser comprises receiving exhaled breath into the first condenser, and recirculating at least part of the collected residual breath through the condenser comprises recirculating at least part of the collected residual breath through the second condenser.
A breath condensing apparatus, the apparatus comprising: a mouthpiece, a condenser having an inlet in fluid communication with the mouthpiece, a container for collecting condensate in fluid communication with an outlet of the condenser, and one or more heating elements for maintaining residual, non-condensed exhaled breath gaseous and at a temperature of between approximately 30° C. and approximately 42° C.
a container for collecting condensate in fluid communication with an outlet of the condenser, and
one or more heating elements for maintaining residual, non-condensed exhaled breath gaseous and at a temperature of between approximately 30° C. and approximately 42° C.
The apparatus according to claim 3
[Truncated to input limit]