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 .
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 3, 6, 11, 12, 14 - 16, 21, 24, and 26 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.
In regard to claim 3, lines 1 - 2 recite, “the tubular body of the first part is coaxial with the tubular body of the second part…” However, “the tubular body of the first part” and “the tubular body of the second part” lack antecedent basis.
In regard to claim 6, claim 6 depends from claim 5, which has been cancelled. The metes and bounds of claim 6 are unclear because there is uncertainty about what claim details are being included in claim 6. For the purpose of examination, Examiner is assuming that claim 6 depends from and includes the limitations of claim 1.
In regard to claim 11, claim 11 depends from claim 10, which has been cancelled. The metes and bounds of claim 11 are unclear because there is uncertainty about what claim details are being included in claim 11. For the purpose of examination, Examiner is assuming that claim 11 depends from and includes the limitations of claim 1.
In regard to claim 12, claim 12 depends from claim 9, which has been cancelled. The metes and bounds of claim 12 are unclear because there is uncertainty about what claim details are being included in claim 12. For the purpose of examination, Examiner is assuming that claim 12 depends from and includes the limitations of claim 1. Additionally, it is unclear if the coupling mechanism disclosed in claim 12 is the same as the coupling mechanism disclosed in claim 1 between the second part of the housing and the sample collection tube and would thus require the coupling mechanism between the second part of the housing and the sample collection tube to include a first set of threads or a frustoconical portion and a plurality of ribs extending from the frustoconical portion and additionally an angled coupling surface or if the angled coupling surface is meant to describe the coupling mechanism between the first and second part of the housing. Further detail is required to define the metes and bounds of the claim.
In regard to claim 14, claim 14 depends from claim 13, which has been cancelled. The metes and bounds of claim 14 are unclear because there is uncertainty about what claim details are being included in claim 13. For the purpose of examination, Examiner is assuming that claim 14 depends from and includes the limitations of claim 1.
Additionally, claim 14 recites, “the plurality of radial ribs comprises radial ribs.” However, “the plurality of radial ribs” lacks antecedent basis. It is also unclear if “the plurality of radial ribs” is the same as “a plurality of ribs extending from the frustoconical portion” disclosed in claim 1. Claims 15 and 16 are rejected by virtue of dependence on claim 14.
In regard to claim 21, lines 1 - 2 recite, “a sample collection tube capable of coupling with the second part and/or the coupling portion,” while claim 1 from which claim 21 depends recites that “the second part comprises a coupling mechanism constructed for coupling with a sample collection tube”. The phrasing of claim 21 is unclear because “the second part” and “the coupling portion” are implied to be separate pieces that the sample collection tube is capable of coupling with while claim 1 describes “the coupling portion” as a component of “the second part”, making the claim limitations of claim 21 inconsistent with claim 1.
In regard to claim 24, line 4 recites, “the exhalation piece or portion,” while claim 1, lines 3 - 4 recite, “the first part comprising an exhalation piece”. The phrase “the exhalation piece or portion,” make the metes and bounds of claim 24 unclear because the “portion” is not defined and is inconsistent with the requirements of claim 1. Claim 26 is rejected by virtue of dependence on claim 24.
In regard to claim 26, lines 1 - 2 recite, “the transferring is done by applying a liquid onto the porous sample collection media.” However, claim 24 from which claim 26 depends includes the limitation, “the transferring is done by pushing with a plunger.” It is unclear if both “applying a liquid onto the porous sample collection media” and “pushing with a plunger” is required to meet the claim limitations of claim 26 or if “applying a liquid onto the porous sample collection media” is meant to take the place of “pushing with a plunger”. Further clarification is required to define the metes and bounds of the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6, 11, 12, and 14 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 6 depends from claim 5, which has been cancelled. Claim 11 depends from claim 10, which has been cancelled. Claim 12 depends from claim 9, which has been cancelled. Claim 14 depends from claim 13, which has been cancelled. Additionally, claim 14 recites, “the plurality of radial ribs comprises radial ribs.” However, this claim is not further limiting because a plurality of radial ribs would have to comprise radial ribs by definition and the claim does not give further details about the radial ribs that would further describe the structure. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1 - 4, 6, 7, 20 - 24, & 26 are rejected under 35 U.S.C. 103 as being unpatentable over Wohl (WO 2022155392 A1) in view of Penezina (US 20040242714 A1).
In regard to claim 1, Wohl discloses a sample collection device (FIG. 18) comprising:
a housing comprising a first part and a second part removably coupled with one another, and an airflow path extending through the first and second parts, the first part comprising an exhalation piece and the second part comprising a coupling end constructed for coupling with a sample collection tube; Wohl discloses that the sample collection device (FIG. 18) which includes a housing (FIG. 18, see “Housing”) comprises a modular design with a first part made up of an upper portion (FIG. 18, see “Air & Reagent Flow Chamber”) and a second part made up of bottom portion (FIG. 18, see “Bottom chamber”). The first and second parts are modular, where the first part is removably coupled to the second part using a coupling mechanism such as screw threading (paragraph [00124]; FIG. 19A). Wohl further discloses that the first part comprises an exhalation piece where the patient breaths and directs air into the inlet (FIG. 1) and an airflow pathway between the first and second part of the collection device (FIG. 1, see “Air flow out”). Wohl additionally discloses that the second part can be configured to reversibly couple to a sample collection tube or vial (FIG. 22B, see “Vial connected to device).
and porous sample collection media, partially disposed between the first and second parts and arranged to occlude the airflow path. Wohl further discloses a capture substrate or porous sample collection media (FIG. 18, see “capture substrate”) configured to collect material contained in a bio-aerosol sample (paragraph [0077]) where the capture substrate is made up of synthetic fibers or electret film composed of poly lactic acid or polypropylene (paragraph [0085 - 0086]). Wohl further discloses that the capture substrate is porous where the pore size of the capture substrate can be selected based on the analyte of interest (paragraph [0077]).
wherein the second part comprises a coupling mechanism constructed for coupling with a sample collection tube, the coupling mechanism comprising either a first set of threads or a frustoconical portion and a plurality of ribs extending from the frustoconical portion. Wohl additionally discloses that the second part can be configured to reversibly couple to a sample collection tube or vial (FIG. 22B, see “Vial connected to device). Wohl further discloses that each housing unit of the sample collection device can include multiple modular elements that can be attached and detached from the device, where the modular elements can be coupled by threads, friction-fittings, or other appropriate coupling mechanisms suitable for reversibly coupling the elements (paragraph [00108]).
While Wohl discloses a porous sample collection media (FIG. 18, see “capture substrate”) configured to collect material contained in a bio-aerosol sample (paragraph [0077]) made out of synthetic fibers or electret film composed of poly lactic acid or polypropylene (paragraph [0085 - 0086]), they do not specify that the porous sample collection media comprises nonwoven material.
However, Penezina teaches a porous membrane used to capture or immobilize biomolecules (paragraph [0080]) can be configured to a variety of forms including flat sheets, hollow fibers, or tubes of any shape. The porous membrane is composed of any suitable porous substrate including polypropylene and compose fibers that are non-woven (paragraph [0061]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the porous sample collection media or capture substrate disclosed by Wohl with the teaching of Penezina that a porous sample collection media can comprise non-woven fibers composed of polymeric materials such as polypropylene because Wohl already discloses that the porous sample collection media comprise fibers that polymeric materials including polypropylene and modifying the porous sample collection media with the non-woven porous sample collection media taught by Penezina would be considered simple substitution of one known element for another to obtain the predictable result of capturing biological samples on a substrate.
In regard to claim 2, Wohl as modified discloses the invention of claim 1, wherein each of the first part and the second part comprise a tubular body. Wohl discloses that the first part and second part of the housing (FIG. 18, see “Air & Reagent Flow Chamber” and “Bottom Chamber”) are tubular.
In regard to claim 3, Wohl as modified discloses the invention of claim 1, wherein the tubular body of the first part is coaxial with the tubular body of the second part when the first and second parts are coupled. Wohl discloses Wohl discloses that the first part and second part of the housing (FIG. 18, see “Air & Reagent Flow Chamber” and “Bottom Chamber”) are tubular and fit within one another when coupled (FIGs. 18 & 19).
In regard to claim 4, Wohl as modified discloses the invention of claim 1, wherein the second part comprises a ledge and the first part comprises a distal end, and wherein an outer edge of the porous sample collection media is captured between the ledge and the distal end when the first and second parts are coupled. Wohl discloses that the coupling mechanism between the first and second parts of the housing (FIG. 18, see “Air & Reagent Flow Chamber” and “Bottom chamber”) additionally act to capture and hold the capture substrate or porous sample collection media in place within the device housing (paragraph [00124]).
In regard to claim 6, Wohl as modified discloses the invention of claim 1, wherein the nonwoven material comprises polylactic acid, polypropylene, or a combination thereof. Consistent with the 112(b) and 112(d) rejection issued on claim 6 for its dependence from cancelled claim 5, Examiner is interpreting claim 6 to depend from and include the limitations of claim 1. Wohl discloses that the capture substrate or porous sample collection media (FIG. 18, see “capture substrate”) is made up of synthetic fibers or electret film such as poly lactic acid or polypropylene (paragraph [0085 - 0086]).
In regard to claim 7, Wohl as modified discloses the invention of claim 1, wherein the first and second parts are coupled by bayonet coupling, interference fit, snap fit, or threaded coupling. Wohl discloses that the first and second parts of the housing are removably coupled using a coupling mechanism such as screw threading (paragraph [00124]; FIG. 19A).
In regard to claim 20, Wohl as modified discloses the invention of claim 1, and further discloses a system for collecting a sample from breath comprising the sample collection device of claim 1 and a plunger for releasing the porous sample collection media from the housing. Wohl discloses that the system includes different mechanisms for transferring and collecting the capture substrate (FIG. 20, see “Capture substrate) or porous sample collection media including a movable internal plunger (FIG. 20B; paragraph [0034]).
In regard to claim 21, Wohl as modified discloses the invention of claim 20, further comprising a sample collection tube capable of coupling with the second part and/or the coupling portion. Wohl discloses a sample collection tube or vial (FIG. 22B, see “Vial connected to device) that can be configured to reversibly couple to the second part of the housing (FIG. 22B, see “Vial connected to device).
In regard to claim 22, Wohl as modified discloses the invention of claim 20, wherein the system is constructed to release the porous sample collection media into the sample collection tube coupled with the sample collection device upon pushing with the plunger. Wohl discloses that the system includes different mechanisms for transferring and collecting the capture substrate (FIG. 20, see “Capture substrate) or porous sample collection media including a movable internal plunger (FIG. 20B; paragraph [0034]). The plunger is used to apply pressure to the capture substrate or porous sample collection media and release the porous sample collection media into the reversibly attached sample collection tube (paragraph [00125]; FIG. 20).
In regard to claim 23, Wohl as modified discloses the invention of claim 20, further comprising a seal between (1) the second part or the coupling portion and (2) the sample collection tube. Wohl discloses that the coupling mechanism between modular components, specifically the first and second part of the housing, is configured to form a seal (paragraph [0012]). One of ordinary skill in the art would recognize that the coupling mechanism used for the other modular components of the device, including the second part and sample collection tube which are reversibly coupled, would also form a seal between modular components.
In regard to claim 24, Wohl as modified discloses the invention of claim 1, and further discloses a method of obtaining a sample using a sample collection device comprising:
providing the sample collection device of claim 1. Wohl discloses that the sample collection device of claim 1 is provided to a subject or patient (paragraph [00104]).
breathing into the exhalation piece or portion to collect a sample on the porous sample collection media. Wohl discloses that the subject or patient breaths or directs an air sample through the mouth, one or both nostrils, or a combination of the mouth and nose (paragraph [00104]). Wohl further discloses that the air expelled by the subject enters the sample collection device through an inlet where the air travels to a capture substrate or porous sample collection media that is positioned within the bio-aerosol collection device where analytes contained in the bioaerosol sample are captured (paragraph [00104]).
coupling the housing with a sample collection tube; Wohl discloses that the second part of the housing is coupled with a sample collection tube (FIGs. 22A - 22C).
and transferring the collected sample on the porous sample collection media into the sample collection tube, wherein the transferring is done by pushing with a plunger. Wohl discloses that the system includes different mechanisms for transferring and collecting the capture substrate (FIG. 20, see “Capture substrate) or porous sample collection media including a movable internal plunger (FIG. 20B; paragraph [0034]). The capture substrate or porous sample collection media is transferred directly into the sample collection tube that is reversibly coupled to the device (paragraph [00126]; FIG. 21B).
In regard to claim 26, Wohl as modified discloses the invention of claim 24, wherein the transferring is done by applying a liquid onto the porous sample collection media. Wohl discloses that the system includes different mechanisms for transferring and collecting the capture substrate, including applying an elution liquid to the capture substrate or porous sample collection media and entirely or partially dislodging the capture substrate such that the sample is collected in the sample collection tube reversibly attached to the second part of the housing (FIGs. 22A - 22C; paragraph [0036]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Wohl (WO 2022155392 A1) in view of Penezina (US 20040242714 A1) as applied to claim 1 above, and further in view of Friedman (US 20090187113 A1)
In regard to claim 8, Wohl discloses the invention of claim 1. While Wohl discloses a housing, they do not specify that the housing comprises a finger support extending outwardly from a body of the first part or the second part.
However, Friedman teaches a breath collecting device with a facemask assembly or housing coupled to a collection vial to provide an inlet for breath collection (paragraph [0019]). Friedman further teaches a finger support extending outwardly from the breath collection device housing (FIG. 3, component 206) to allow finger placement while removing or connecting the modular components of the system together (paragraph [0057]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to have modified the sample collection device disclosed by Wohl with the teaching of Friedman that a housing of a sample collection device can include a finger support extending outwardly from a body of a housing of a sample collection device because it would be considered combining prior art elements, in this case the first or second parts of the housing disclosed by Wohl and the finger support taught by Friedman, to yield the predictable result of assembling and removing modular pieces of a sample collection device.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Wohl (WO 2022155392 A1) in view of Penezina (US 20040242714 A1) as applied to claim 1 above, and further in view of Boone (US 5582723 A).
In regard to claim 11, Wohl discloses the invention of claim 1. Consistent with the 112(b) and 112(d) rejection issued on claim 11 for its dependence from cancelled claim 10, Examiner is interpreting claim 11 to depend from and include the limitations of claim 1. While Wohl discloses that each housing unit of the sample collection device can include multiple modular elements that can be attached and detached from the device, including the second part of the housing and a sample collection tube (FIG. 22B), where the modular elements can be coupled by threads, friction-fittings, or other appropriate coupling mechanisms suitable for reversibly coupling the elements (paragraph [00108]), they do not specify that the coupling mechanism comprises a second set of threads of a different size than the first set of threads.
However, Boone teaches a coupling mechanism that includes two sets of screw threads (FIG. 4, components 66 and 62) where the first set of threads (FIG. 4, component 66) are larger than that of the second set of threads (FIG. 4, component 62). Having two sets of threads on opposite sides of the coupling mechanism allows for the coupling of a component (FIG. 4, component 60) to two other components at the same time (FIG. 4, component 16 & 68).
It would have been obvious to one of ordinary skill prior to the effective filing date of the claimed invention to have modified the sample collection device disclosed by Wohl with the teaching of Boone that a coupling mechanism can include two sets of screw threads (FIG. 4, components 66 and 62) where the first set of threads (FIG. 4, component 66) are larger than that of the second set of threads (FIG. 4, component 62) because Wohl already discloses that multiple methods can be utilized to couple modular elements including the use of threads, friction-fittings, or other appropriate coupling mechanisms suitable for reversibly coupling the elements (paragraph [00108]) and additionally that the second part of the housing can be removably coupled to both the first part of the housing and a sample collection tube or vial (FIGs. 18 & 22A - 22C), using the coupling mechanism taught by Boone would be considered simple substitution of one known element for another, in this case the coupling mechanisms, to yield the predictable result of attaching components of a modular device together.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Wohl (WO 2022155392 A1) in view of Penezina (US 20040242714 A1) as applied to claim 1 above, and further in view of Bolan (US 6016255 A).
In regard to claim 12, Wohl discloses the invention of claim 1. Consistent with the 112(b) and 112(d) rejection issued on claim 12 for its dependence from cancelled claim 9, Examiner is interpreting claim 11 to depend from and include the limitations of claim 1. While Wohl discloses that each housing unit of the sample collection device can include multiple modular elements that can be attached and detached from the device, including the second part of the housing and a sample collection tube (FIG. 22B), where the modular elements can be coupled by threads, friction-fittings, or other appropriate coupling mechanisms suitable for reversibly coupling the elements (paragraph [00108]), they do not specify that the coupling mechanism comprises an angled coupling surface.
However, Bolan teaches a coupling mechanism with an angled coupling surface where one part (FIG. 41I, component 3800) is pushed into the structure of a second part (FIG. 41I, component 4182) and the deformation of the second part holds the first part by the flange or angled coupling surface (See annotated FIG. 41I below).
PNG
media_image1.png
127
464
media_image1.png
Greyscale
It would have been obvious to one of ordinary skill prior to the effective filing date of the claimed invention to have modified the sample collection device disclosed by Wohl with the teaching of Bolan that includes a coupling mechanism with an angled coupling surface because Wohl already discloses that multiple methods can be utilized to couple modular elements including the use of threads, friction-fittings, or other appropriate coupling mechanisms suitable for reversibly coupling the elements (paragraph [00108]), such that using the coupling mechanism taught by Bolan would be considered simple substitution of one known element for another, in this case the coupling mechanisms, to yield the predictable result of attaching components of a modular device together.
Claims 14 - 16 are rejected under 35 U.S.C. 103 as being unpatentable over Wohl (WO 2022155392 A1) in view of Penezina (US 20040242714 A1) as applied to claim 1 above, and further in view of Kelly (US 6179787 B1).
In regard to claim 14, Wohl discloses the invention of claim 1. Consistent with the 112(b) and 112(d) rejection issued on claim 14 for its dependence from cancelled claim 13, Examiner is interpreting claim 14 to depend from and include the limitations of claim 1 and further, Examiner is interpreting the claim to mean that the coupling mechanism between the second part of the housing and the sample collection tube comprises multiple radial ribs. While Wohl discloses that each housing unit of the sample collection device can include multiple modular elements that can be attached and detached from the device, including the second part of the housing and a sample collection tube (FIG. 22B), where the modular elements can be coupled by threads, friction-fittings, or other appropriate coupling mechanisms suitable for reversibly coupling the elements (paragraph [00108]), they do not specify that the plurality of radial ribs comprises radial ribs.
However, Kelly teaches a coupling mechanism between a part of a collection container (FIG. 3, component 78) and a removable bottom portion (FIG. 3, component 100) that includes a plurality of annular ribs (FIG. 3, component 106) that provide an interface or friction fit between the two components (Column 4, lines 35 - 67, & Column 5, lines 22 - 28).
It would have been obvious to one of ordinary skill prior to the effective filing date of the claimed invention to have modified the sample collection device disclosed by Wohl with the teaching of Kelly that includes a coupling mechanism with a plurality of annular ribs because Wohl already discloses that multiple methods can be utilized to couple modular elements including the use of threads, friction-fittings, or other appropriate coupling mechanisms suitable for reversibly coupling the elements (paragraph [00108]), such that using the coupling mechanism taught by Kelly would be considered simple substitution of one known element for another, in this case the coupling mechanisms, to yield the predictable result of attaching components of a modular device together.
In regard to claims 15 & 16, Wohl as modified discloses the invention of claim 14, wherein the radial ribs comprise a first rib adjacent the coupling end and having a first diameter, and a second rib having a second diameter that is greater than the first diameter. One of ordinary skill in the art would recognize that the size of the radial ribs would influence the attachment or fit of modular components that are designed to be reversibly coupled to one another. As such, one could optimize the diameters of the individual ribs making up the plurality of radial ribs, including to have the parameters as set forth in claims 15 and 16, to provide an optimal fit between component pieces such as the second part of the housing and sample collection tube described by Wohl.
Claims 17 - 18 are rejected under 35 U.S.C. 103 as being unpatentable over Wohl (WO 2022155392 A1) in view of Penezina (US 20040242714 A1) as applied to claim 1 above, and further in view of Borody (US 5273032 A).
In regard to claim 17, Wohl discloses the invention of claim 14. While Wohl discloses a bio-aerosol collection device with a first part (FIG. 18, see “Air & Reagent Flow Chamber”) comprising an inlet that a patient breaths into (FIG. 1, see “closable inlet” and “Patient directs air sample into inlet”) and allows airflow to the rest of the sampling device, Wohl does not specify that the first part comprises a flange extending outwardly from a proximal end of the tubular body.
However, Borody teaches a mouth piece that allows airflow that comprises a short rigid tube (FIG. 4, component 7) that opens into a flange (FIG. 4, component 9) at the proximal end such that the flange contacts and overlays the lip area of a patient and allowing for a comfortable contact with the tubing.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to have modified the sample collection system disclosed by Wohl with the teaching of Borody that an inlet can include a mouthpiece with a flange that allows airflow through the tube because both Wohl and Borody are interested in structures that allow for airflow between a device and the mouth of a patient, modifying the inlet disclosed by Wohl with the teaching of Borody would be considered combining prior art elements, in this case the inlet tube disclosed by Wohl with the mouthpiece taught by Borody, according to known methods to yield the predictable result of facilitating airflow between a device and the mouth of a patient. Additionally, the modification would be obvious because Borody teaches that this modification allows for comfortable contact between the patient and the tubing.
In regard to claim 18, Wohl as modified discloses the invention of claim 17, wherein the flange comprises a cut-away (See annotated Borody, FIG. 4 below).
PNG
media_image2.png
241
340
media_image2.png
Greyscale
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lampropoulos (US 20220178922 A1) discloses a pathogen sampling and testing device and method that includes the collection of breath samples through a modular sample collection device (FIG. 4A; paragraph [0002]) with a reversibly coupled sample collection tube (FIG. 4A, component 300) and flange on the proximal end of a first part of a housing (FIG. 4A, component 404)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIENNA CHRISTINE PYLE whose telephone number is (703)756-5798. The examiner can normally be reached 8 am - 5:30 pm M - T; Off first Fridays; 8 am - 4 pm second Fridays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor, II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
/S.C.P./Examiner, Art Unit 3791