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 .
Applicant’s preliminary amendment filed on June 29, 2023 is acknowledged. Claims 1-14 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 29, 2023 has been considered by the examiner.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (CN 111337669 2020-06-26 in IDS on 6/29/2023) in view of Kamradt et al. (US Patent Application Publication US 2022/0236267).
Regarding preset claims 1-3.Wang et al. teaches a method of detection of viruses such as SARS-CoV-2 comprising using a device comprising a body, and at least one support, the method comprising obtaining a water sample entering the device wherein the water sample undergoes an the immuno-chromatographic reaction on the support of said device or of said system, first on the examination portion and then on the control portion of said support; thereby allowing evaluating a concentration of the at least one environmental contaminant present in the air or water sample by relating said concentration to a standard concentration scale (see paragraphs [0009-0016], [0044], and Example 1).
Regarding preset claims 4, 10 and 12-14. Wang et al. teaches gold-labeled SARS-CoV-2 lgM and lgG antibodies attached to the absorbent pad react with a SARS-CoV-2 antigen to form an antigen-antibody complex, said complex travels to a nitrocellulose membrane and binds to the ACE2 protein linked to biotin, avidin and HRP on the detection line T which changes color, while gold-labeled SARS-CoV-2 lgM and lgG antibodies travelling to the control line C will react with anti-lgM and anti-lgG antibodies triggering a color change of the control line C) (see Example 1).
Regarding preset claim 5. Wang teaches Spike-RBD anti-SARS-CoV-2 antibody ( "The antibody ACE2 protein on the detection line T recognizes the antigen to be tested". The antibody ACE2 protein is known as a cell receptor binding with the receptor binding domain (RBD) of the spike protein of SARS-CoV-2).
Regarding preset claim 6. Wang further discloses that the support is a nitrocellulose membrane ( "the support plate 5 is made of non-absorbent material, such as PVC or other hard materials, and a nitrocellulose membrane is fixed on the support plate 5", "The NC membrane of the reaction color-developing zone 3'].
Wang does not expressly teach the device comprising body, at least one hole, at least one filter and at least one support, said at least one support being equipped with a first part equipped with at least one examination portion and with a second part equipped with at least one control portion.
Regarding claims 1-3 and 7-9 and 11. Kamradt et al. teaches a system comprising the device and an air circulation/recirculation system ( "air filter 200 within an air handling system'1, wherein said device (100) is installed into said circulation/recirculation/exhaust system lateral flow immunoassays and detectors for detecting toxin and antigen presence or absence of target airborne particles, comprising: at least one lateral flow immunochromatographic assay having a filter sample window therein, the filter sample window configured to collect target airborne particles flowing through an airborne environment for use in the at least one lateral flow immunochromatographic assay; and wherein the at least one lateral flow immunochromatographic assay indicates the presence or absence of the target airborne particles (see claims 1, 4-8, paragraphs [0046]).
It would have been prima facie obvious to provide the Wangs method using Wang’s assay wherein the device is constructed to resemble the device of Kamradt, because Kamradt teaches that his device can be adapted to perform an immunoassay on environmental pathogens such as viruses (see paragraphs [0007-0008]).
Kamradt paragraph [0007] In additional embodiments, the filter toxin and antigen detectors disclosed herein may be used on positive pressure airway devices, including respiration/ventilation/breathing devices, including continuous positive airway pressure (CPAP) devices, and bilevel positive airway pressure devices (BIPAP). In these embodiments, the filter toxin and antigen detectors may be integrated into a cassette, test cartridge, or test strip that fits onto a port (such as the inlet/inhalation port or expiratory end) of a respiration/ventilation/breathing/CPAP/BIPAP device to detect/test if the machine is clean of harmful toxins, antigens, viruses, bacteria, etc. The detectors may provide a quick test result (within 10-15 minutes) of device cleanliness or contamination. These detectors can reduce the rate of ventilator associated pneumonia (VAP) in medical facilities, could also easily be used on home CPAP/BIPAP machines, and could quickly become the standard of care in the monitoring of respiratory equipment cleanliness and safety.
[0008] The ability to monitor air quality for the presence of harmful toxins or antigens may be utilized for a multitude of scenarios, including, but not limited to residential or commercial detection of toxic mold, hospital or heath care monitoring for infectious airborne diseases (such as Tuberculosis, Norovirus, or Legionnaire's disease), identification of biologic toxin exposure (such as Anthrax, Ebola, or Smallpox virus in military installations), identification of airborne communicable diseases in areas of public transit (such as airliners or cruise ships), identification of bacterial pathogens causing ventilator associated pneumonia (the most common nosocomial infection of critically ill patients) etc. within respirators, ventilators, CPAP/BIPAP devices, etc.
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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, Thomas Visone can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648