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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/21/25, 09/19/224, 01/31/24, 10/02/23 and 07/18/23 have been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Invention I (Claims 37-55 and 74-78) in the reply filed on 02/02/26 is acknowledged. Invention II (Claims 56-71) have been withdrawn
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 37-46, 48-51, 53-55 and 74-78 are rejected under 35 U.S.C. 103 as being unpatentable over Kline (US 2004/0162500 A1) and in further view of Sato (JPH 07103974 A) and Baddour (US 2003/0208132 A1).
Kline and Sato were applied in Applicant’s IDS filed on 10/02/23
Baddour was applied in Applicant’s IDS filed on 09/19/24
Regarding claim 37, Kline teaches an endothermic device for collecting a biological sample from breath of a user [fig. 1, element 10; par. 17, 66, 85], the device comprising: (a) a tube [fig. 1, element 24] adapted to allow the user to exhale their breath into the device [par. 17, 85]; (b) a collection chamber [fig. 1, element 82] in fluid communication with the tube [par. 17], the collection chamber having a capture surface [fig. 20, element 94; par. 80]; and (c) a receptacle [fig. 1, element 80] for receiving the collection chamber [par. 79], the receptacle containing a coolant that undergoes an endothermic process to cool the capture surface to a temperature at or below the freezing point of water [par. 84], whereby the biological sample from the breath of the user condenses or freezes on the capture surface of the collection chamber [par. 84], wherein the tube has a first end for the user to exhale into the device [fig. 5, element 14; par. 17], and wherein the receptacle is a disposable article [par. 88]
However, Kline does not teach the collection chamber is disposed over a second end of the tube
Sato teaches the collection chamber is disposed over a second end of the tube [fig. 1, elements 12, 18; par. 14, 20]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kline, to incorporate the collection chamber is disposed over a second end of the tube, for ensuring the collection tube is sufficiently cooled, as evidence by Sato [par. 20].
However, Kline does not teach whereby a direction of the flow of breath exiting the second end of the tube is reversed towards the capture surface
Baddour teaches whereby a direction of the flow of breath exiting the second end of the tube is reversed towards the capture surface [par. 41]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kline, to incorporate whereby a direction of the flow of breath exiting the second end of the tube is reversed towards the capture surface, for helping to improve condensation efficiency along the walls of collecting tube, as evidence by Baddour [par. 41].
Regarding claim 38, Kline further teaches the receptacle is configured to retain the collection chamber in contact with the coolant [par. 80]
Regarding claim 39, Baddour further teaches a turbulence inducer disposed in or around the tube to cause flow of breath to become turbulent to enhance contact between the capture surface and exhaled breath of the user [fig. 4, element 65; par. 41]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kline, to incorporate a turbulence inducer disposed in or around the tube to cause flow of breath to become turbulent to enhance contact between the capture surface and exhaled breath of the user, for helping to improve condensation efficiency along the walls of collecting tube, as evidence by Baddour [par. 41].
Regarding claim 40, Kline further teaches the collection chamber has an interior capture surface [par. 84], whereby flow of breath flows so that the biological sample condenses or freezes on the interior capture surface [par. 84].
However, Kline does not teach the collection chamber is a vial, whereby flow of breath reverses around interior walls of the vial
Baddour teaches the collection chamber is a vial [fig. 1, element 60; par. 39, 40], whereby flow of breath reverses around interior walls of the vial [par. 41, 42]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kline, to incorporate the collection chamber is a vial, whereby flow of breath reverses around interior walls of the vial, for sealing the condensate sample within collecting tube, preventing any fluid exchange with matter or air outside of collecting tube, and helping to improve condensation efficiency along the walls of collecting tube, as evidence by Baddour [par. 39, 41].
Regarding claim 41, Kline further teaches wherein the collection chamber comprises a syringe barrel, and wherein the tube is configured to fit into the syringe barrel [fig. 1, element 80; par. 66].
Regarding claim 42, Sato further teaches the collection chamber terminates with a closed end collector [fig. 1, element 12; par. 14].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kline, to incorporate the collection chamber terminates with a closed end collector, for containing the refrigerant in the cooling vessel, as evidence by Sato [par. 20].
Regarding claim 43, Baddour further teaches the collection chamber has a volume between 0.5 mL and 50 mL [par. 34; Examiner notes that with the given dimensions, the volume may be between 0. 5mL and 50 mL]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kline, to incorporate the collection chamber has a volume between 0.5 mL and 50 mL, for preventing low condensation efficiency, as evidence by Baddour [par. 34].
Regarding claim 44, Baddour further teaches the capture surface has a surface area of less than or equal to 50 cm2 [par. 34; Examiner notes that with the given dimensions, the surface area may be less than or equal to 50 cm2]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kline, to incorporate the capture surface has a surface area of less than or equal to 50 cm2, for preventing low condensation efficiency, as evidence by Baddour [par. 34]
Regarding claim 45, Sato further teaches wherein the coolant is dry ice [par. 16].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kline, to incorporate the coolant is dry ice, for allowing the exhaled air to be cooled sufficiently in the collecting section, and for the components in the exhaled breath to condense or sublimate together with the water vapor in the exhaled breath and adhere to the inner wall of the collection section, as evidence by Sato [par. 11].
Regarding claim 46, Kline further teaches the coolant is a coolant mixture comprising two or more components [par. 80; Examiner notes the coolant comprises ammonium nitrate and water]
Regarding claim 48, Kline further teaches further comprising a mixing vessel for combining and mixing the components of the coolant mixture [par. 80; Examiner notes the condensing chamber acts as a mixing vessel].
Regarding claim 49, Baddour further teaches the mixing vessel comprises a first mixing container [fig. 1, element 70; par. 37] and a second mixing container [fig. 1, element 60; par. 37], the first and second mixing containers being connectable in a first configuration to define an enclosed mixing volume [Examiner notes the first configuration is that of the first mixing container being connected to the second mixing container in order to slide over the second mixing container; par. 5, 37]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kline, to incorporate the mixing vessel comprises a first mixing container and a second mixing container, the first and second mixing containers being connectable in a first configuration to define an enclosed mixing volume, for cooling the cooling sleeve to a temperature lower than that of the collecting tube prior to being slid thereover, as evidence by Baddour [par. 5].
Regarding claim 50, Baddour further teaches the first and second mixing containers are connectable in a second configuration to define the receptacle [fig. 1; elements 60, 70; par. 37; Examiner notes the second configuration is when the first mixing container is fully slid over the second mixing container]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kline, to incorporate the first and second mixing containers are connectable in a second configuration to define the receptacle, for allowing the first mixing container to cool the second mixing container, as evidence by Baddour [par. 37].
Regarding claim 51, Baddour further teaches the first and second mixing containers each comprise a tubular section, and wherein the first mixing container is dimensioned to be sleeved around the second mixing container in the second configuration [[fig. 1; elements 60, 70; par. 37].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kline, to incorporate the first and second mixing containers each comprise a tubular section, and wherein the first mixing container is dimensioned to be sleeved around the second mixing container in the second configuration, for allowing the first mixing container to cool the second mixing container, as evidence by Baddour [par. 37].
Regarding claim 53, Baddour further teaches the receptacle is substantially devoid of metal [par. 34, 37; Examiner notes the collecting tube may be made of plastic and the cooling sleeve may be made of any high specific heat, durable, reusable material which does not deteriorate when wet and tends to retain and maintain a low temperature when cooled]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kline, to incorporate the receptacle is substantially devoid of metal, for functioning to collect, condense and store vaporized and aerosolized particles from breath exhaled thereinto, as evidence by Baddour [par. 34].
Regarding claim 54, Kline further teaches the collection chamber is made from paper or plastic material [par. 79]
Regarding claim 55, Kline further teaches the tube is in a vertical configuration, a horizontal configuration, or a configuration between horizontal and vertical [fig. 1, element 24]
Regarding claim 74, Kline further teaches a kit comprising the device of claim 37, wherein the kit comprises a plurality of disposable elements of at least one of the device [par. 66, 69] and reagents for processing the biological sample [par. 95, 97]
Regarding claim 75, Kline further teaches wherein the plurality of disposable elements comprises the receptacle [fig. 1, element 84], and the collection chamber [fig. 1, element 82; par. 88; Examiner notes the syringe comprises the collection chamber].
Baddour teaches wherein the plurality of disposable elements comprises the tube [par. 39]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kline, to incorporate the plurality of disposable elements comprises the tube, for ensuring no complicated cleaning or contamination issues arise from use of device, as evidence by Baddour [par. 39].
Regarding claim 76, Baddour further teaches the plurality of disposable elements further comprises one or more components of the coolant [par. 58, “all wetted parts of device 10 can easily be made disposable to minimize contamination, cleaning, and cost”]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kline, to incorporate the plurality of disposable elements further comprises one or more components of the coolant, to minimize contamination, cleaning, and cost, as evidence by Baddour [par. 58].
Regarding claim 77, Kline further teaches the plurality of disposable elements further comprises a plastic mouthpiece cover [par. 66].
Regarding claim 78, Kline further teaches the plurality of disposable elements further comprises one or more components of the coolant and a plastic mouthpiece cover [par. 66]
Baddour teaches the plurality of disposable elements further comprises one or more components of the coolant [par. 58, “all wetted parts of device 10 can easily be made disposable to minimize contamination, cleaning, and cost”]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kline, to incorporate the plurality of disposable elements further comprises one or more components of the coolant, to minimize contamination, cleaning, and cost, as evidence by Baddour [par. 58].
Claim 47 is rejected under 35 U.S.C. 103 as being unpatentable over Kline, Sato and Baddour and in further view of Aguren (US 2023/0175042 A1).
Regarding claim 47, Kline, Sato and Baddour teach an endothermic device for collecting a biological sample from breath of a user, as disclosed above
However, Kline, Sato and Baddour do not teach the two or more components of the coolant mixture comprise any of:(a) water and ice; (b) water and ammonium chloride;(c) water and sodium nitrate (III);(d) water and ammonium thiocyanate;(e) ice and sodium acetate;(f) ice and ammonium chloride;(g) ice and sodium chloride;(h) ice and ammonium nitrate (V);(i) ice and sodium bromide;(j) ice and potassium chloride;(k) ice and magnesium chloride;(1) ice and sulfuric acid (VI) 66%; and(m) ice and calcium chloride hexahydrate
Aguren teaches the two or more components of the coolant mixture comprise any of:(a) water and ice; (b) water and ammonium chloride;(c) water and sodium nitrate (III);(d) water and ammonium thiocyanate;(e) ice and sodium acetate;(f) ice and ammonium chloride;(g) ice and sodium chloride;(h) ice and ammonium nitrate (V);(i) ice and sodium bromide;(j) ice and potassium chloride;(k) ice and magnesium chloride;(1) ice and sulfuric acid (VI) 66%; and(m) ice and calcium chloride hexahydrate [par. 59 “coolants using water and ammonium nitrate, calcium ammonium nitrate or urea causing an endothermic reaction”]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kline, Sato and Baddour, to incorporate the two or more components of the coolant mixture comprise any of: (a) water and ice; (b) water and ammonium chloride;(c) water and sodium nitrate (III);(d) water and ammonium thiocyanate;(e) ice and sodium acetate;(f) ice and ammonium chloride;(g) ice and sodium chloride;(h) ice and ammonium nitrate (V);(i) ice and sodium bromide;(j) ice and potassium chloride;(k) ice and magnesium chloride;(1) ice and sulfuric acid (VI) 66%; and(m) ice and calcium chloride hexahydrate, for causing an endothermic reaction, as evidence by Aguren [par. 59].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791