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 § 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 1-2, 6, 8-9, 11-16, 25-27, 29-30, 33, 53, and 55 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reddy US20200337594.
Regarding claim 1, Reddy discloses a method (Abstract, system-100 implements the method) for diagnosing a subject for a COVID-19 infection state (Paragraph 0123), comprising: collecting an exhaled breath sample from a subject (Paragraph 0121); passing the breath sample into contact with a volatile organic compound (VOC) sensor operable to detect at least one VOC biomarker for a COVID-19 infection state (Paragraph 0046, 0121-0123, 0201); producing a readable sensor output for the at least one VOC biomarker (Paragraph 0045-0046, 0241); and diagnosing the COVID-19 infection state of the subject based on the readable sensor output (Paragraph 0096-0097).
Regarding claim 2, Reddy discloses the sensor comprises a GC-MS. (Paragraph 0088)
Regarding claim 6, Reddy discloses the at least one VOC biomarker is selected from the group consisting of an ester having a molecular weight of less than 200 g/mol, an aldehyde and a terpene. (Paragraph 0038, paragraph 0145)
Regarding claim 8, Reddy discloses the aldehyde is selected from the group consisting of Hexanal, 3,5,5-trimethyl-;5-Heptenal, 2,6-dimethyl; isomers thereof; and a combination of two or more thereof. (Paragraph 0038, 0110, 0113-0117, 0145)
Regarding claim 9, Reddy discloses the terpene is selected from the group consisting of o-Cymene; Eucalyptol; alpha-Bisabolene; beta-Bourbonene; alpha-Phellandrene; alpha-Cedrene; Dihydromyrcenol; 3-Thujene; Terpinene; Linalool; D-Limonene; Camphor; 1- Menthone; Copaene; Terpinen-4-ol; Caryophyllene; 3-carene; and a combination of two or more thereof.
Regarding claim 11, Reddy discloses the at least one VOC biomarker comprises at least two unsaturated terpenes, each having 5, 10 or 15 carbons, and at least one aldehyde. (Paragraph 0030, 0038, 0050-0054, 0110, 0149)
Regarding claim 12, Reddy discloses the at least one VOC biomarker comprises at least three VOCs wherein at least two of the VOCs are terpenes. (Paragraph 0030, 0038, 0050-0054, 0110, 0149)
Regarding claim 13, Reddy discloses the at least one VOC biomarker comprises at least three VOCs wherein at least one of the VOCs is a terpene and at least one of the VOCs is an aldehyde or a ketone. (Paragraph 0030, 0038, 0050-0054, 0110, 0149)
Regarding claim 14, Reddy discloses the at least one VOC biomarker comprises at least three VOCs wherein at least one of the VOCs is an aldehyde and at least one of the VOCs is a ketone. (Paragraph 0030, 0038, 0050-0054, 0110, 0149)
Regarding claim 15, Reddy discloses the at least one VOC biomarker comprises at least three VOCs wherein at least one of the VOCs is an aldehyde and at least one of the VOCs is an alcohol. (Paragraph 0030, 0038, 0050-0054, 0107, 0193, 0203, 0207)
Regarding claim 16, Reddy discloses the at least one VOC biomarker comprises at least three VOCs wherein at least two of the VOCs are esters and at least one of the VOCs is a terpene. (Paragraph 0030, 0038, 0050-0054, 0110, 0149)
Regarding claim 25, Reddy discloses determining a correlation between the readable sensor output and a predefined signal or signal pattern associated with the COVID-19 infection state (Paragraph 0241); and identifying, based at least in part on the determination of a correlation with the predefined signal or signal pattern, the presence of the COVID-19 infection state (Paragraph 0034, 0096, 0201-0202).
Regarding claim 26, Reddy discloses processing the readable sensor output via a neural network or pattern recognition algorithm, wherein the readable sensor output correlates with a predefined signal or signal pattern associated with the COVID-19 infection state (Paragraph 0088); and identifying, based at least in part on the determination of a correlation with the predefined signal or signal pattern, the presence of the COVID-19 infection state (Paragraph 0034, 0091, 0096, 0201-0202).
Regarding claim 27, Reddy discloses the VOC sensor comprises a first sensor component operable to expose one or more nanoparticles to a first one of the at least one VOC biomarker in the alveolar air breath sample (Paragraph 0053), wherein the one or more nanoparticles are operable to react to a presence of or contact with the first of the at least one VOC biomarker (Paragraph 0054); a second sensor component operable to generate an electronic signal when the one or more nanoparticles react to the presence of or contact with the first of the at least one VOC biomarker (Claim 18),; wherein the electronic signal is associated with a concentration or amount of the first of the plurality of VOC biomarkers (Claim 18); and an electronic circuit (Claim 18) operable to transmit the electronic signal to an output device or computer processor.
Regarding claim 29, Reddy discloses a system (system-100) for detecting and identifying at least one VOC biomarker for a COVID-19 infection state in exhaled breath of a subject (Paragraph 0121-0123), the system comprising: a mouth piece (mouth piece-106) connected to a housing (housing-104), the mouth piece operable to receive the exhaled breath of the subject (Paragraph 0037); a sensor module (sensor module-108) disposed in the housing, the sensor module operable to detect the at least one VOC biomarker in the exhaled breath (Paragraph 0046, 0121-0123, 0201), and further operable to produce a readable sensor output for the at least one VOC biomarker (Paragraph 0045-0046, 0241); and a communication module (module--10) disposed in the housing and in communication with the sensor module, the communication module operable to transmit collected data from the sensor module (Paragraph 0037, 0078-0081).
Regarding claim 30, Reddy discloses the sensor module (module-108) comprises at least one array of sensor subunits, wherein each sensor subunit is operable to detect at least one VOC biomarker. (Paragraph 0046-0054, 0062-0077)
Regarding claim 33, Reddy discloses the at least one VOC biomarker is selected from the group consisting of an ester having a molecular weight of less than 200 g/mol, an aldehyde and a terpene. (Paragraph 0038, paragraph 0145)
Regarding claim 53, Reddy discloses a biomarker processing module (module-122) in communication with the sensor module (module-108), the biomarker processing module operable to process the collected data associated with detection of the at least one VOC biomarker and to identify the at least one VOC biomarker. (Paragraph 0055, 0078, 0080-0081, 0084, 0086-0088, 0091, 0094-0097)
Regarding claim 55, Reddy discloses the biomarker processing module (module-122) is further operable to process the collected data in conjunction with other sensor data, wherein a result from the biomarker processing module is received by the communication module (module-110) for output to a software application loaded on a computer or a hand-held electronic device. (Paragraph 0055, 0078, 0080-0081, 0084, 0086-0088, 0091, 0094-0098)
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.
Claims 3, 7, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Reddy US20200337594 in view of Respiration Scan LTD WO2021028928 (hereinafter “Respiration”).
Regarding claim 3, Reddy discloses the method according to claim 2.
However, Reddy fails to disclose the sensor comprises a GC-MS QTOF. Respiration disclose the sensor comprises a GC-MS QTOF. (Page 36, Paragraph 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date to include the design of Respiration into Reddy for the purpose of increasing detection accuracy. The modification would allow for higher formula determination and increased spectral clarity.
Regarding claim 7, Reddy disclose the method according to claim 6.
However, Reddy fails to disclose the ester is selected from the group consisting of Acetic Acid, hexyl ester; 3,5,5-Trimethylhexyl acetate; Bicyclo[2.2.1] heptan-2-ol, 1,3,3- trimethyl-, acetate, (1 S-exo)-; 4-tert-Butylcyclohexyl acetate; Benzenemethanol, alpha-methyl-, acetate; alpha-Terpinyl acetate, isomers thereof; and combinations of two or more thereof. Respiration discloses the ester is selected from the group consisting of Acetic Acid, hexyl ester; 3,5,5-Trimethylhexyl acetate; Bicyclo[2.2.1] heptan-2-ol, 1,3,3- trimethyl-, acetate, (1 S-exo)-; 4-tert-Butylcyclohexyl acetate; Benzenemethanol, alpha-methyl-, acetate; alpha-Terpinyl acetate, isomers thereof; and combinations of two or more thereof. (Page 7 paragraph 3 – Page 8 paragraph 1, Page 14 paragraph 5- Page 15 Paragraph 3, Claim 27)
It would have been obvious to one of ordinary skill in the art before the effective filing date to include the design of Respiration into Reddy for the purpose of increasing detection accuracy. The modification would allow for higher formula determination in diagnosing if a patient has COVID-19 or not.
Regarding claim 10, Reddy disclose the method according to claim 6.
However, Reddy fails to disclose the at least one VOC biomarker is selected from the group consisting of Acetic Acid, hexyl ester; Hexanal, 3,5,5-trimethyl-; o-Cymene; Eucalyptol; 3,5,5-Trimethylhexyl acetate; Bicyclo[2.2.1] heptan-2-ol, 1,3,3-trimethyl-, acetate, (1S-exo)-; Cyclohexane, 2-butyl-1,1,3-trimethyl-; Linalool; 1-Decanol, 2-ethyl-; alpha- Bisabolene; 2-Octanone; alpha-Cedrene; 5-Heptenal, 2,6-dimethyl-; beta-Bourbonene; alpha- Phellandrene; Nonane, 2,2,4,4,6,8,8-heptamethyl-; Dihydromyrcenol; 3-Thujene; Terpinene; Hexane, 3,4-bis(1,1-dimethylethyl)-2,2,5,5-tetramethyl-; Benzene, 1,3-dichloro-; Hexane, 1- (hexyloxy)-5-methyl-; Nonane, 3,7-dimethyl-; D-Limonene; Camphor; Dodecane, 2,7,10- trimethyl-; Hexadecane; 4-tert-Butylcyclohexyl acetate; 3-Undecene, 5-methyl-; alpha-Terpinyl acetate; 3-carene; 1-Menthone; Copaene; Undecane, 2,3-dimethyl-; Diethyl Phthalate; Terpinen- 4-ol; Toluene; 2-Undecene, 9-methyl-; Caryophyllene; Benzenemethanol, alpha-methyl-, acetate; isomers thereof; and a combination of two or more thereof. Respiration the at least one VOC biomarker is selected from the group consisting of Acetic Acid, hexyl ester; Hexanal, 3,5,5-trimethyl-; o-Cymene; Eucalyptol; 3,5,5-Trimethylhexyl acetate; Bicyclo[2.2.1] heptan-2-ol, 1,3,3-trimethyl-, acetate, (1S-exo)-; Cyclohexane, 2-butyl-1,1,3-trimethyl-; Linalool; 1-Decanol, 2-ethyl-; alpha- Bisabolene; 2-Octanone; alpha-Cedrene; 5-Heptenal, 2,6-dimethyl-; beta-Bourbonene; alpha- Phellandrene; Nonane, 2,2,4,4,6,8,8-heptamethyl-; Dihydromyrcenol; 3-Thujene; Terpinene; Hexane, 3,4-bis(1,1-dimethylethyl)-2,2,5,5-tetramethyl-; Benzene, 1,3-dichloro-; Hexane, 1- (hexyloxy)-5-methyl-; Nonane, 3,7-dimethyl-; D-Limonene; Camphor; Dodecane, 2,7,10- trimethyl-; Hexadecane; 4-tert-Butylcyclohexyl acetate; 3-Undecene, 5-methyl-; alpha-Terpinyl acetate; 3-carene; 1-Menthone; Copaene; Undecane, 2,3-dimethyl-; Diethyl Phthalate; Terpinen- 4-ol; Toluene; 2-Undecene, 9-methyl-; Caryophyllene; Benzenemethanol, alpha-methyl-, acetate; isomers thereof; and a combination of two or more thereof. (Page 7 paragraph 3 – Page 8 paragraph 1, Page 14 paragraph 5- Page 15 Paragraph 3, Claim 27)
It would have been obvious to one of ordinary skill in the art before the effective filing date to include the design of Respiration into Reddy for the purpose of increasing detection accuracy. The modification would allow for higher formula determination in diagnosing if a patient has COVID-19 or not.
Conclusion
The prior art as cited on the PTO-892 is made of record and not relied upon but considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIGEL H PLUMB whose telephone number is (571)272-8886. The examiner can normally be reached Monday-Friday 7am-5pm.
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, John Breene can be reached at 571-272-4107. 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 (USA or CANADA) or 571-272-1000.
/NIGEL H PLUMB/Examiner, Art Unit 2855
/Eric S. McCall/Primary Examiner, Art Unit 2855