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.
Claim(s) 57-63, 65-74, 77-81 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Wang et al (USP 4663277).
Regarding claim 57, Wang teaches a diagnostic platform for detecting a biological pathogen in a sample (Abstract: dipstick for detecting virus), the platform comprising at least one XRF identifiable marker operably linked via complexation or ionic or covalent interaction (Col. 5 lines 5-14; Claim 15) to at least one functional component associable with the biological pathogen for detecting the biological pathogen or a part thereof, wherein the functional component enables marking the pathogen in the sample with the at least one XRF identifiable marker, wherein the at least one functional component is a component of a polymerase chain reaction (PCR), a reverse transcription, a nucleic acid hybridization, an antibody test, or a serological antibody test (col. 7 lines 21-50: microspheres with antibody (Abv) specific to antigens of viruses and detected by X-ray fluorescence).
Regarding claims 58, 67, Wang teaches the at least one XRF identifiable marker and the at least one functional component are operably linked by at least one non-specific (multifunctional) component. (col. 5 lines 11-25: F.sub.c portion linking the Ab.sub.v)
Regarding claim 59, Wang teaches the at least one functional component is a component of a polymerase chain reaction (PCR), a reverse transcription, a nucleic acid hybridization, an antibody test, a serological antibody test. (col. 5 lines 10-35: antibody test)
Regrading claim 60, Wang teaches the at least one functional component is a nucleotide, an oligonucleotide, an amino acid, a peptide. (col. 7 line 29; col. 53-56: conjugated Ab.sub.v, reads on "a conjugate")
Regarding claim 61, Wang teaches the at least one functional component is a primary of a secondary antibody (col. 5 lines 20-30: Ab.sub.v and Ab.sub.s).
Regarding claims 62, 72, Wang teaches the biological pathogen is a viral or a bacterial pathogen in a mammalian disease (col. 8 lines 18-36: Measles virus, Hepatitis A and B viruses).
Regarding claims 63, 74, Wang teaches the sample is a biological sample obtained from a mammal at risk of being infected or already infected with the biological pathogen (Col. 8 lines 18-36: nasal secretions, stool).
Regarding claims 65, 77, Wang teaches the biological sample is a sample of a body fluid, a body discharge, a body secretion obtained from a mammal at risk of being infected or already infected with the biological pathogen (Col. 8 lines 18-36: nasal secretions, stool).
Regarding claim 66, Wang teaches a composition comprising at least one XRF identifiable marker operably linked to at least one functional component for detecting a biological pathogen or a part thereof, for marking the pathogen with the at least one XRF identifiable marker that is detectable by an XRF reading device. (col. 7 lines 21-50: microspheres with Abv specific to antigens of viruses and detected by X-ray fluorescence).
Regarding claim 68, Wang teaches a method for detecting a biological pathogen in a sample, the method comprises contacting the sample with diagnostic platform according to claim 57, thereby marking the pathogen in the sample with the at least one XRF identifiable marker wherein upon association of the at least one functional component linked to the at least one XRF identifiable marker with the pathogen, the formed construct is identifiable by an XRF-based device; and irradiating said sample with X-ray or gamma-ray radiation to thereby determine presence or absence of the construct and thereby of the pathogen.. (col. 7 lines 21-50: microspheres with Abv specific to antigens of viruses and detected by X-ray fluorescence).
Regarding claims 70, Wang teaches for determining presence of a virus in the sample. (col. 7 lines 21-50: detected by X-ray fluorescence inherently irradiates with x-ray radiation, see USP 4,436,826 incorporated by reference col. 4 lines 5-15, x-ray irradiation to detect x-ray fluorescence).
Regarding claim 71, Wang teaches the at least one XRF identifiable marker, the at least one functional component are operably linked by covalent bond. (col. 5 lines 11-25: F.sub.c portion linking the Ab.sub.v; Ab.sub.s is covalently bound to the solid phase)
Regarding 73, Wang teaches the mammalian disease is a human disease. (col. 8 lines 18-36: Measles virus, Hepatitis A and B viruses).
Regarding claim 78, Wang teach the biological sample is a sample of blood, serum, saliva, a sample of nasal or lung discharge, urine or fecal sample or a sample of tear drops.(Col. 8 lines 18-36: nasal secretions, stool)
Regarding claim 79, Wang teach the microspheres can include Abs (col. 8 lines 57-58: Example 1: Abs rabbit anti goat) that interacts to the Goat Abv (col. 9 lines 1-2, Example 1: Goat Abv anti-cytomegalovirus). It is noted that the Abs antibody on the microsphere (reads on as the "XRF identifiable marker") interactions with the Abv include electrostatic interaction in how the anti-goat antibody on the Abs interacts with the goat antibody of the Abv ("ionic interaction to an amino acid or a peptide selected to interact or associate with a viral pathogen").
Regarding claim 80, Wang teach the microsphere is labelled with different metal elements and antibodies (col. 7 line 40-48: Abv proteins conjugated to microsphere labelled with different metal elements, reads on "organometallic complex of a metal atom and an organic ligand")
Regarding claim 81, Wang teach the at least one functionality is selected and operable to selectively associate to at least one region of a virus (Wang: col. 5 lines 23-25: functional epitope Abv for the viral Ag)
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 64 and 76 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Hart et al US 2002/0164582.
Regarding claims 64 and 76, Wang teach detecting a viral pathogen, but is silent to the viral or the bacterial pathogen is selected from the pathogens of Cholera, Plague and Yellow Fever, Severe Acute Respiratory Syndrome (SARS), Ebola, Zika, Middle East Respiratory Syndrome (MERS) (See 112 rejection), Human Immunodeficiency Virus (HIV/AIDS), Influenza A (H1N1)pdm/09, Tuberculosis (TB) and Corona Virus Disease 19 (COVID-19).
Hart et al teach a method for detecting the presence of Ebola virus in a sample using fluorescent antibody spectroscopy or colorimetry to provide diagnosis of an Ebola virus infection. (Para. 0053). It is desirable to detect Ebola virus in a sample to provide early detection and prevent widespread infections of the highly infectious Ebola from spreading. Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the virus in Wang for Ebola of Hart et al to provide the above advantage of preventing widespread infections of the highly infectious Ebola from spreading.
Claim(s) 75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Hart et al US 2002/0164582 and further in view of Casanova et al, "Assessment of Self-Contamination During Removal of Personal Protective Equipment for Ebola Patient Care" Infection Control & Hospital Epidemiology. 2016;37(10):1156-1161.
Regarding claim 75, Wang teach samples to detect viruses but are silent to the sample is a non-biological sample obtained from a surface, an object, or a part thereof, which was in contact or is suspected to be in contact with a mammal at risk of being infected or already infected with the biological pathogen.
Casanova et al teach the sample for detecting viruses can be the personal protective equipment to prevent viral self-contamination. It is desirable to detect highly infectious viruses on the PPE to ensure the healthcare personnel are protected against exposure. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the e sample is a non-biological sample obtained from a surface, an object, or a part thereof, which was in contact or is suspected to be in contact with a mammal at risk of being infected or already infected with the biological pathogen of Casanova to the method of Wang to provide the above advantage of ensuring the healthcare personnel are protected against exposure.
Response to Arguments
Regarding 35 USC 112b, the arguments are persuasive and the rejection is withdrawn.
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive. Applicants argue that Wang teaches that the XRF marker is provided in the microspheres, but that the markers are neither complex, or ionically associated, or covalently associated therewith. This is not convincing because the interaction with the anti-virus antibody (Abv) and the mobile solid phase are covalently bound (Col. 5 lines 5-14; Claim 15). The argument that the "In Wang, the construct is complex. At col. 5, line 9, the system is depicted as: solid-phase+Abv+viral antigen+Abv+microspheres containing XRF marker. The platform of the present invention can be comparatively described as: XRF marker+Abv (or other component)+viral antigen…As may be noted, the system of the present invention is much simpler and does not require the complexity of a solid and a mobile phase." is not convincing because the argument is not commensurate with the claim limitations. The claim does not require having only "a single functional component for associating to the virus, as claimed" as the claim uses the "comprising" language that is open for additional components.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS MICHAEL WHITE whose telephone number is (571)270-3747. The examiner can normally be reached M-F 8:30am-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, Maris R. Kessel can be reached at (571) 270-7698. 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.
/Dennis White/Primary Examiner, Art Unit 1758