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 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 are the “analysis unit” and “processing unit” in claim 15.
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.
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 3 - 7, 10, 11, 14, 15, & 19 - 23 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 - 3 recite, “the collecting device… further comprising a reagent inlet for providing a liquid reagent into an analysis chamber.” However, as written, it is unclear if a separate chamber is required to act as the analysis chamber in addition to the particle collection chamber, or if the particle collection chamber of claim 1 is the same as the analysis chamber of claim 3 as stated on page 5 of the specification submitted by Applicant. Further clarification is required. Claims 4 - 6 are rejected by virtue of dependence on claim 3. Claims 10, 14, 15, and 20 are rejected on the same grounds as claim 3 above and claims 21 - 23 are rejected by virtue of dependence on claim 20.
In regard to claim 7, lines 2 - 3 recite, “wherein the inlet nozzles are configured at the second end to have a diameter in the range of 20 - 300 μm, such as 100 - 200 μm.” However, the metes and bounds of the claim are unclear because multiple ranges of diameter values are claimed. Further clarification is required.
In regard to claim 11, lines 1 - 8 indicate that the collecting device is configured to receive a liquid reagent and receive heat to carry out a process of particle lysis and DNA amplification. However, it is unclear what structure of the collecting device is generating the heat or controlling the processes of particle lysis and DNA amplification. As written, the claim only requires that the collecting device be able to receive a liquid reagent and heat in some way and the details about carrying out a process of particle lysis and DNA amplification are merely intended use. Claim 23 is rejected on the same grounds as claim 11 above.
In regard to claim 14, line 3 recites, “the analysis chamber,” which lacks antecedent basis. The phrase “the analysis chamber,” should be amended to -- an analysis chamber --.
In regard to claim 15, line 7 recites, “the analysis chamber,” which lacks antecedent basis. The phrase “the analysis chamber,” should be amended to -- an analysis chamber --.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 - 4, 6 - 8, & 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takenaka (US 20160223435 A1 - CITED BY APPLICANT).
In regard to claim 1, Takenaka discloses a collecting device for collection of particles and presentation of collected particles for analysis (FIG. 1, component 1), said collecting device comprising:
a first layer and a second layer, wherein the first layer and the second layer are arranged to be spaced apart for defining a particle collection chamber between the first and the second layer, wherein the particle collection chamber has a first and a second side defined by the first layer and the second layer, respectively; Takenaka discloses a first layer (see annotated FIG. 1, component 112) and second layer (see annotated FIG. 1, component 114) with a small gap or space between the first and second layer that makes up a particle collection chamber (see annotated FIG. 1, paragraph [0051]).
PNG
media_image1.png
485
640
media_image1.png
Greyscale
wherein the first layer comprises a first surface configured to receive a flow of air carrying airborne particles and a second surface facing the second layer, wherein the first layer comprises a plurality of inlet nozzles having a first end at the first surface of the first layer and a second end at the second surface of the first layer, wherein the inlet nozzles are configured to extend through the first layer for transporting the flow of air therethrough from the first end to the second end; Takenaka discloses that the first layer (see annotated FIG. 1, component 112) is configured to receive a flow of air through a coupling pipe (see annotated FIG. 1, component 1281; paragraph [0073]) where air flows in the direction of the first layer to the second layer (see annotated FIG. 1, component 1222; paragraph [0054]) and the air contains particles such as a microorganism or viral particle (FIG. 1, component 150; paragraphs [0049], [0052]). Takenaka further discloses that the first layer (see annotated FIG. 1, component 112) includes a plurality of inlet nozzles (see annotated FIG. 1, component 115) that extend from the surface of the first surface of the first layer to the second layer of the first surface that faces in to the spacing between the first and second layer (FIG. 1). The inlet nozzles are configured to facilitate the flow of air from the first end to the second end of the first layer into the spacing between layers and to the second layer (FIG. 1, component 1222).
PNG
media_image2.png
485
640
media_image2.png
Greyscale
wherein the second ends of the inlet nozzles are configured to face a first surface of the second layer for capturing airborne particles in the flow of air entering the particle collection chamber through the second ends of the inlet nozzles by impaction of airborne particles on the first surface of the second layer; Takenaka discloses the second ends of the inlet nozzles are configured to face a first surface of the second layer in the direction of air flow (FIG. 1, component 1222) where the particles are pushed through the particle collection chamber through the inlet nozzles. Takenaka further discloses that the particles are collected on the first surface of the second layer using an impaction method (paragraph [0054]), where the air carrying the particles is forced through the plurality of inlet nozzles (FIG. 1, component 115) and then flows in a different direction around the surface of the second layer (FIG. 1, component 114). The particles are collected when they collide with the surface of the second layer due to an inertial force that causes deviation of the movement of the particles from the flow of air (paragraph [0054]).
wherein the collecting device is configured to provide optical access for performing a measurement, based on light, of airborne particles collected in the particle collection chamber at a first measurement position arranged such that the second layer is between the second side of the particle collection chamber and the first measurement position or at a second measurement position, which is arranged at an opposite side to the first measurement position in relation to the second side of the particle collection chamber. Takenaka discloses that the collecting device is configured to provide optical access for performing a light based measurement of the collected airborne particles where the second layer (FIG. 1, component 114) acts as an optical window for fluorescent imaging using an optical sensor (FIG. 1, component 124; paragraph [0087]). The second layer functions as a light-guiding path of the excitation light and fluorescence (FIG. 1, components 1241 & 1242) for imaging the collected particles, which is achieved by making the second layer (FIG. 1, component 114) from an optically transparent resin such as glass, quartz, or other transparent resin material (paragraph [0087]). Takenaka further discloses that the second layer is between the particle collection chamber (See annotated FIG. 1 above) and the first measuring position (FIG. 1, component 124).
In regard to claim 2, Takenaka discloses the invention as set forth for claim 1, wherein the second layer comprises a plurality of outlet nozzles, wherein the outlet nozzles have a first end at the first surface of the second layer and a second end at a second surface of the second layer and the outlet nozzles are configured to extend through the second layer for transporting the flow of air therethrough from the first end to the second end, wherein a position of the first ends of the outlet nozzles is shifted with respect to a position of the second ends of the inlet nozzles such that the outlet nozzles are not collinear with the inlet nozzles. Takenaka discloses that the second layer includes a plurality of outlet nozzles (FIG. 1, component 116; paragraph [0052]) where the outlet nozzles have a first end at the first surface of the second layer facing in to the particle collection chamber and a second end at a second surface of the second layer in the direction of airflow (FIG. 1, component 1222). Takenaka further discloses that the outlet nozzles are not collinear with the inlet nozzles, which can be seen in FIG. 1 where the outlet nozzles further on the periphery of the second layer than the inlet nozzles of the first layer (See annotated FIG. 1 below).
PNG
media_image3.png
485
640
media_image3.png
Greyscale
In regard to claim 3, Takenaka discloses the invention as set forth for claim 1, further comprising a reagent inlet for providing a liquid reagent into an analysis chamber. Takenaka discloses the use of a reagent container (FIG. 2, component 123) which is coupled with the particle collecting and analysis device of FIG. 1 (paragraph [0059]) and provides a vent or inlet (FIG. 2, component 1222) that supplies a liquid reagent, such as a mist that comprises fluorescence dye liquid, into an analysis chamber (see Annotated FIG. 2 below). Examiner notes that Applicant states that the particle collection chamber may also form an analysis chamber and the terms "particle collection chamber" and "analysis chamber" may be used interchangeably on page 5 of the specification.
PNG
media_image4.png
381
542
media_image4.png
Greyscale
In regard to claim 4, Takenaka discloses the invention as set forth for claim 3, wherein the collecting device is configured to seal the analysis chamber for trapping a liquid sample in the analysis chamber. Takenaka discloses that the device includes a pipe (FIG. 2, component 1281) that couples the breath collection bag (FIG. 1, component 121) and the liquid reagent container (FIG. 1, component 123) to the analysis chamber (See annotated FIG. 2 above). Takenaka further discloses that a valve for opening or closing a pipe used for coupling elements can include a valve for opening or closing the pipe (paragraph [0091]). One of ordinary skill in the art would recognize that closing the pipe would seal the analysis chamber.
In regard to claim 6, Takenaka discloses the invention as set forth for claim 4, wherein the collecting device comprises valves for sealing the analysis chamber. Takenaka further discloses a valve for opening or closing a pipe used for coupling elements can include a valve for opening or closing the pipe (paragraph [0091]). One of ordinary skill in the art would recognize that closing the pipe would seal the analysis chamber.
In regard to claim 7, Takenaka discloses the invention as set forth for claim 1, wherein the inlet nozzles are configured at the second end to have a diameter in a range of 20-300 μm, such as 100-200 μm. Takenaka discloses that the dimensions of the inlet nozzles (FIG. 1, component 115) include a diameter of 70 μm (paragraph [0068]), which is substantially within the designated range of 20 - 300 μm as specified in claim 7. Takenaka further discloses that an optimum diameter of each of the inlet nozzles (FIG. 1, component 115) changes according to a measurement objection (paragraph [0083]).
In regard to claim 8, Takenaka discloses the invention as set forth for claim 1, wherein a number of inlet nozzles is larger than 100. Takenaka discloses that the optimum number of inlet nozzles (FIG. 1, component 115) changes according to a measurement object (paragraph [0083]). Takenaka further discloses that in an example where viral particles are being collected, the number of inlet nozzles is within the range of 1 to 10,000 inlet nozzles (paragraph [0084]), which substantially encompasses the range of greater than 100 inlet nozzles specified in claim 8.
In regard to claim 19, Takenaka discloses a method for collection of particles for analysis, said method comprising:
passing a flow of air carrying airborne particles through a plurality of inlet nozzles through a first layer of a collecting device for passing the flow of air from the inlet nozzles into a particle collection chamber, wherein the particle collection chamber has a first and a second side defined by the first layer and a second layer, respectively; Takenaka discloses a first layer (FIG. 1, component 112) and second layer (FIG. 1, component 114) with a small gap or space between the first and second layer that makes up a particle collection chamber (paragraph [0051]). The air sample carrying airborne particles (FIG. 1, component 150) passes through the plurality of inlet nozzles (FIG. 1, component 115) on the first layer of the collecting device into the particle collection chamber (FIG. 1, component 1222).
and capturing airborne particles through impaction in the particle collection chamber by the flow of air being passed into the particle collection chamber impinging on a first surface of the second layer facing the first layer in the particle collection chamber; Takenaka further discloses that the particles are collected on the first surface of the second layer using an impaction method (paragraph [0054]), where the air carrying the particles is forced through the plurality of inlet nozzles (FIG. 1, component 115) and then flows in a different direction around the surface of the second layer (FIG. 1, component 114). The particles are collected when they collide with the surface of the second layer due to an inertial force that causes deviation of the movement of the particles from the flow of air (paragraph [0054]).
wherein the particle collection chamber provides optical access for performing a measurement, based on light, of airborne particles collected in the particle collection chamber at a first measurement position arranged such that the second layer is between the second side of the particle collection chamber and the first measurement position or at a second measurement position, which is arranged at an opposite side to the first measurement position in relation to the second side of the particle collection chamber. Takenaka discloses that the collecting device is configured to provide optical access for performing a light based measurement of the collected airborne particles where the second layer (FIG. 1, component 114) acts as an optical window for fluorescent imaging using an optical sensor (FIG. 1, component 124; paragraph [0087]). The second layer functions as a light-guiding path of the excitation light and fluorescence (FIG. 1, components 1241 & 1242) for imaging the collected particles, which is achieved by making the second layer (FIG. 1, component 114) from an optically transparent resin such as glass, quartz, or other transparent resin material (paragraph [0087]). Takenaka further discloses that the second layer is between the particle collection chamber (See annotated FIG. 1 above) and the first measuring position (FIG. 1, component 124).
Claims 20 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park (US 20170059466 A1 - CITED BY APPLICANT).
In regard to claim 20, Park discloses method for analysis of samples of particles in air, said method comprising:
receiving a plurality of sample collectors in a plurality of receiving positions of an analysis instrument, wherein each sample collector comprises a collecting device carrying a sample of airborne particles being captured in an analysis chamber in the collecting device by impaction therein; Park discloses a method for measuring airborne microbial particles that includes a plurality of sample collectors (FIG. 2, component 215), each made up of one hole in the analysis instrument (FIG. 2, component 200), where each sample collector is in a plurality of receiving positions of the analysis instrument (FIG. 2, component 200). Each sample collector includes a collecting device (FIG. 2, component 220) and a space that acts as an analysis chamber where the microbial particles are collected by impaction onto the filter part which acts as a collecting device (FIG. 2, component 220; paragraph [0067]).
performing measurements based on light in each of the receiving positions, wherein a light detector detects light from the sample in the analysis chamber while the collecting device is arranged in the sample collector; Park discloses that the filter case (FIG. 2, component 210) is able to rotate to expose each collecting device to a light receiving device (FIG. 6, component 320; paragraph [0062]), which is part of a luminescence measurement device (FIG. 1, component 300) used to collect light emitted from the captured particles within each collection device (paragraph [0070]).
and processing a signal from the light detector for analyzing the sample. Park discloses that the light receiving part (FIG. 6, component 320) is configured to detect and amount or intensity of light emitted from the microbial particles in the analysis chamber of each collection device using a control device (FIG. 1, component 400; paragraphs [0048] & [0071]).
Examiner notes that applicant includes the phrasing, “method for analysis of samples of particles in human breath,” in the preamble. However, the preamble does not hold patentable weight and intended claim limitations should be included in the body of the claim. Additionally, while Park is concerned with sampling and analysis of airborne pathogens, it would be obvious to one of ordinary skill in the art that a breath sample would be considered to be an air sample that could be input into the system for analysis.
In regard to claim 21, Park discloses the invention as set forth for claim 20, further comprising, before performing measurements, introducing a liquid reagent in the analysis chamber, while the collecting device is arranged in the sample collector. Park further discloses that their method includes supplying a lysis reagent to the analysis chamber of the collecting device (FIG. 2, component 220) via a lysis agent supply device (FIG. 4, component 370) which delivers a lysis reagent to each filter hole or collecting device (FIG. 2, component 220) via a supply passage (FIG. 4, component 375).
Claim Rejections - 35 USC § 103
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Takenaka (US 20160223435 A1 - CITED BY APPLICANT) as applied to claim 4 above, and further in view of Hill (US 7631567 B1).
In regard to claim 5, Takenaka discloses the invention as set forth for claim 4. Takenaka does not disclose that the inlet nozzles comprise a first portion extending from the first end to a constriction arranged at the second end of the inlet nozzles, wherein the inlet nozzles has a smaller cross-sectional size in the constriction than in the first portion for forming a capillary force to maintain the liquid sample in the analysis chamber.
However, Hill teaches a system for collecting particles where an inlet nozzle (FIG. 1, component 120) has a smaller cross-sectional size in the constriction at the second end of the inlet nozzle that prevents the fluid in a chamber (FIG. 1, component 108) from flowing in the direction of the inlet nozzle via capillary forces (Column 13, lines 1 - 8), causing the liquid to remain in the chamber (FIG. 1, component 108).
It would have been obvious to one of ordinary skill in the art to have modified the inlet nozzles disclosed by Takenaka with the teaching that an inlet nozzle can have a smaller cross-sectional size in the constriction at the second end of the inlet nozzle that causes liquid remain in the chamber via capillary forces because designing inlet nozzles with a smaller cross-sectional size in the constriction prevents the liquid sample from escaping from the analysis chamber (Hill, Column 13, lines 1 - 8).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Takenaka (US 20160223435 A1 - CITED BY APPLICANT) as applied to claim 1 above, and further in view of Holmes (US 20130078733 A1).
In regard to claim 9, Takenaka discloses the invention as set forth for claim 1. While Takenaka does not specifically disclose that the collecting device is configured to provide a collection efficiency of at least 50% for particles having a diameter larger than 300 nm when the collecting device receives a flow of air having a pressure in a range of 10-30 mbar, Takenaka does discuss that different metrics, including diameter and number of inlet nozzles, deviation amount of each inlet nozzle, or suction amount (paragraphs [0069], [0083] - [0084]), may be adjusted according to the measurement object or particle of interest to improve the capture of particles based on the characteristics of the particles of interest, such as diameter of the particle (paragraph [0083] - [0084]).
Schwoebel additionally teaches that collection efficiency of particles using an impactor device can be improved by adjusting parameters such as the flowrate, sampling rate, sampling time (paragraph [0534]) and modification to the collection surface including additional coating promoting adhesion of biological particles or changing the surface geometry to promote deposition of particles in defined regions of the surface of the collecting chamber (paragraph [0252].
It would have been obvious to one of ordinary skill in the art to have modified the invention disclosed by Takenaka with the teaching of Schwoebel that collection efficiency of particles using an impactor device can be improved by adjusting design parameters of the device because doing so would allow for the capture of more viral particles for analysis (Schwoebel, paragraph [0252])
While neither Takenaka nor Schwoebel discuss Takenaka a collecting device that is configured to provide a collection efficiency of at least 50% for particles having a diameter larger than 300 nm when the collecting device receives a flow of air having a pressure in a range of 10-30 mbar, one of ordinary skill in the art would recognize that collection efficiency can be optimized through routine experimentation, such as by optimizing different design metrics, including diameter, number and deviation amount of each inlet nozzle (Takenaka, paragraphs [0069], [0083] - [0084]), or altering the surface of the collection portion of the second surface (Schwoebel, paragraph [0252]), such that the collection efficiency would be at least 50% for particles with a diameter larger than 300 nm when air flow has a pressure in a range of 10-30 mbar.
Claims 10 & 11 are rejected under 35 U.S.C. 103 as being unpatentable over Takenaka (US 20160223435 A1 - CITED BY APPLICANT) as applied to claim 1 above, and further in view of Holmes (US 20130078733 A1).
In regard to claim 10, Takenaka discloses the invention as set forth for claim 1. While Takenaka discloses that their system collects and analyzes different types of biological particles from breath samples and additionally provides a liquid sample to an analysis chamber, they do not specify that the system further comprises at least one contact arranged on the first or the second layer for receiving energy to provide heating to a liquid sample in an analysis chamber.
However, Holmes teaches a system and method for sample processing that includes receiving a sample, performing one or more of a sample preparation, assay, and detection steps (paragraph [0016]). Holmes additionally teaches that a sample processing system can include multiple modules within the same structure to perform multiple types of assays, including culture assays, microscopic assays, colorimetric assays, immunoassays, and nucleic acid assays (paragraph [0016]; FIG. 3). The system taught by Holmes additionally includes a cartridge for generating heat locally to enhance the kinetics of a reaction (paragraph [0320]).
It would have been obvious to one of ordinary skill prior to the effective filing date of the claimed invention to have modified the system disclosed by Takenaka with the teaching that a sample preparation and analysis system can include multiple modules for analysis and a cartridge for generating heat locally because it allows for the enhancement of the kinetics of a reaction. One of ordinary skill in the art would recognize that different assays, including fluorescent labelling of a biological sample, can proceed at different rates based on incubation temperature and that the ability to control the kinetics of the reaction by controlling the temperature is beneficial to the system.
In regard to claim 11, Takenaka as modified discloses the invention as set forth for claim 10, wherein the collecting device is configured for receiving a liquid reagent to be mixed with the collected particles in an analysis chamber, receiving heat for thermal lysis to expose RNA of severe acute respiratory syndrome coronavirus 2, SARS-CoV-2, in the collected particles, converting the RNA to DNA using reverse transcriptase based on the reagent in the analysis chamber and providing thermal cycling for amplification of the DNA using quantitative polymerase chain reaction. Examiner notes that the claim as written only requires that the collecting device is able to receive a liquid reagent and able to receive heat stimulus, the steps of mixing particles within the analysis chamber, thermal lysing to expose RNA, and converting RNA to DNA using reverse transcriptase are merely intended use and do not hold patentable weight. Takenaka discloses the use of a reagent container (FIG. 2, component 123) which is coupled with the particle collecting and analysis device of FIG. 1 (paragraph [0059]) and provides a vent or inlet (FIG. 2, component 1222) that supplies a liquid reagent, such as a mist that comprises fluorescence dye liquid, into the analysis chamber and Holmes further teaches the use of a cartridge for generating heat locally to enhance the kinetics of a reaction which includes temperature control isolated to the sample based on the desired test, including nucleic acid tests (paragraph [0320]).
Claims 12 - 14 are rejected under 35 U.S.C. 103 as being unpatentable over Takenaka (US 20160223435 A1 - CITED BY APPLICANT) as applied to claim 1 above, and further in view of Hojer (US 20200221973 A1 - CITED BY APPLICANT).
In regard to claim 12, Takenaka discloses the invention as set forth for claim 1, including the collecting device according to claim 1;
While Takenaka discloses that the breath of a patient is utilized as a sample for the collecting device described above in the 102 rejection of claim 1, they do not disclose that the breath is collected using a mouthpiece for receiving a flow of air from exhalation by a human being or that the collecting device is arranged in the sample collector to receive the flow of air from the mouthpiece.
However, Hojer teaches that the breath of a patient can be collected using a mouthpiece (FIG. 1, component 110) connected to a collecting device (FIG. 1, component 100), where the mouthpiece is configured to allow a subject to exhale air into the system (paragraph [0065]). The breath flows from the mouthpiece down into the direction of the collecting device including the impactor (FIG. 1, component 10) where particles are collected from the breath (FIG. 7, component “P”).
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 system disclosed by Takenaka, including the collected breath used for analysis, with the collection method taught by Hojer where the breath is collected directly from the patient using a mouth piece because it would be considered simple substitution of one known element, in this case the breath bag used for breath collection disclosed by Takenaka, with another, the teaching that breath can be collected using a mouth piece connected to a collection system, to yield the predictable result of analyzing the particles within the breath of a patient.
In regard to claim 13, Takenaka as modified discloses the invention as set forth for claim 12, further comprising a flow meter for providing a measure of a volume of air being provided through the mouthpiece. Hojer further teaches that the system includes two flow meters (FIG. 1, components 118 and 119) downstream of the mouthpiece.
In regard to claim 14, Takenaka as modified discloses the invention as set forth for claim 12, wherein at least a portion of a wall of the sample collector is transparent for enabling analysis of airborne particles in the analysis chamber of the collecting device by a measurement based on light through the transparent portion of the wall of the sample collector. Examiner notes that as written, the sample collector includes the collecting device of claim 1. Takenaka discloses that the collecting device is configured to provide optical access for performing a light based measurement of the collected airborne particles where the second layer (FIG. 1, component 114) acts as an optical window for fluorescent imaging using an optical sensor (FIG. 1, component 124; paragraph [0087, which is achieved by making the second layer (FIG. 1, component 114) from an optically transparent resin such as glass, quartz, or other transparent resin material (paragraph [0087]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Takenaka (US 20160223435 A1 - CITED BY APPLICANT) in view of Hojer (US 20200221973 A1 - CITED BY APPLICANT) as applied to claim 12 above, and further in view of Park (US 20170059466 A1 - CITED BY APPLICANT) and in further view of Maltezos (US 20090275113 A1).
In regard to claim 15, Takenaka as modified discloses the invention as set forth for claim 12, and further discloses an analysis instrument for analyzing difference characteristics of particles in human breath, such as the concentration of particles (FIG. 4B). Takenaka discloses that the analysis system includes a processing unit for processing a signal from the light detector for analyzing the sample (FIG. 19; paragraph [0137]) to detect an airborne substance rapidly and automatically with high sensitivity (paragraph [0017]).
Takenaka does not specify that the analysis system includes:
a holder defining a plurality of receiving positions for receiving a plurality of sample collectors according to claim 12;
a plurality of analysis units, wherein one analysis unit is associated with each receiving position, wherein each analysis unit comprises a light source for illuminating a sample in the analysis chamber of the collecting device of the sample collector, and a light detector for detecting light from the sample;
However, Park teaches a method for measuring airborne microbial particles that includes a holder (FIG. 2, component 200) that includes a plurality of sample collectors (FIG. 2, component 215). Each sample collector includes a collecting device (FIG. 2, component 220) and a space that acts as an analysis chamber where the microbial particles are collected by impaction onto the filter part which acts as a collecting device (FIG. 2, component 220; paragraph [0067]).
It would have been obvious to one of ordinary skill in the art to have modified Takenaka with the teaching of Park that a holder can be used to define a plurality of holding positions of a plurality of sample collectors for analysis because it would be considered combining prior art elements according to known methods to yield the predictable result of collecting particles from a breath sample and analyzing the particles using optical detection methods.
While both Takenaka and Park discuss the use of analysis units with a light source for illuminating a sample and a light detector for detecting light from the sample, they do not specify a plurality of analysis units where each unit includes a light source and light detector.
However, Maltezos teaches an analysis device with optical detection components for detecting a signal from a sample vessel (paragraph [0011]) that can be configured to excite multiple samples using LEDs (paragraph [0130]) with different light sources configured in the optical assembly and separately detected using a plurality of optical detectors, allowing detection of multiple samples to occur at the same time (paragraph [0133]).
It would have been obvious to one of ordinary skill in the art to have modified Takenaka as modified by Park with the teaching that multiple analysis units with a light source and light detector can be used to analyze multiple samples because doing so allows detection of multiple sample to occur at the same time or in parallel (paragraph [0133]).
Claims 22 & 23 are rejected under 35 U.S.C. 103 as being unpatentable over Park (US 20170059466 A1 - CITED BY APPLICANT) as applied to claim 21 above, and further in view of Holmes (US 20130078733 A1).
In regard to claim 22, Park discloses the invention as set forth for claim 21. While Park discloses a sample collection and analysis method that includes introducing a liquid reagent, they do not specifically disclose that their method includes before performing measurements and after introducing a liquid reagent, providing thermal energy to the analysis chamber, while the collecting device is arranged in the sample collector, for controlling a reaction in the analysis chamber.
However, Holmes teaches a system and method for sample processing that includes receiving a sample, performing one or more of a sample preparation, assay, and detection steps (paragraph [0016]). Holmes additionally teaches that a sample processing system can include multiple modules within the same structure to perform multiple types of assays, including culture assays, microscopic assays, colorimetric assays, immunoassays, and nucleic acid assays (paragraph [0016]; FIG. 3). The system taught by Holmes additionally includes a cartridge for generating heat locally to enhance the kinetics of a reaction (paragraph [0320]).
It would have been obvious to one of ordinary skill prior to the effective filing date of the claimed invention to have modified the system disclosed by Park with the teaching that a sample preparation and analysis system can include multiple modules for analysis and a cartridge for generating heat locally because it allows for the enhancement of the kinetics of a reaction. One of ordinary skill in the art would recognize that different assays, including lysing a biological particle or labelling of a biological sample, can proceed at different rates based on incubation temperature and that the ability to control the kinetics of the reaction by controlling the temperature is beneficial to the system.
In regard to claim 23, Park as modified discloses the invention as set forth for claim 22, wherein the thermal energy is provided for thermal lysis to expose RNA of severe acute respiratory syndrome coronavirus 2, SARS-CoV-2, in the captured particles, converting the RNA to DNA using reverse transcriptase based on the reagent in the analysis chamber and providing thermal cycling for amplification of the DNA using quantitative polymerase chain reaction. Examiner notes that the claim as written only requires that the collecting device is able to receive a liquid reagent and able to receive heat stimulus, the steps of mixing particles within the analysis chamber, thermal lysing to expose RNA, and converting RNA to DNA using reverse transcriptase are merely intended use and do not hold patentable weight. Park further discloses that their method includes supplying a lysis reagent to the analysis chamber of the collecting device (FIG. 2, component 220) via a lysis agent supply device (FIG. 4, component 370) which delivers a lysis reagent to each filter hole or collecting device (FIG. 2, component 220) via a supply passage (FIG. 4, component 375) and Holmes further teaches the use of a cartridge for generating heat locally to enhance the kinetics of a reaction which includes temperature control isolated to the sample based on the desired test, including nucleic acid tests (paragraph [0320]).
Conclusion
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