Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claim Status
2. This Office Action is in response to the amendment filed 10 August 2023, wherein Applicant amended claims 1-10 and added new claim 11.
Claims 1-11 are being considered.
Priority
3. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). For the purposes of applying prior art, the effective filing date of the Instant Application will be 11 February 2022.
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on 04 December 2023 was filed after the mailing date of the Instant Application on 10 August 2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
5. Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
6. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http://, www., or other browser-executable code. See MPEP § 608.01. See page 21 of the Instant Specification.
Claim Objections
7. Claim 7 objected to because of the following informalities: “bonding” appears to be a typo. Examiner recommends changing it to “binding”. Appropriate correction is required.
Claim Interpretation
8. According to the Instant Specification on page 14, “Specific antibody/antigen recognition” means that each antibody of the test recognizes and binds to an epitope of an antigen of the SARS-CoV-2 virus in a specific manner. Page 14 of the Instant Specification also defines “immunological test” as a test enabling detection of at least one antigen of SARS-CoV-2. In addition, page 11 of the Instant Specification defines “nasal vestibule” as interchangeable with multiple terms, but the sample must originate from the nasal vestibule, either by swabbing the nostril or having the individual sniff or clear their throat prior to sampling.
Therefore, Examiner is interpreting claims 1 and 9, which recite “at least one antigen specific” and “immunological test”, to be specific for SARS-CoV-2. Claim 1 also recites “secretions from the anterior nasal vestibule”, which will be interpreted as discussed above.
It is noted that any interpretation of the claims set forth does not relieve Applicant of the responsibility of responding to this Office Action. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office Action.
Claim Rejections - 35 USC § 112
9. 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.
10. Claims 1-2 and 4-11 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “virus”, and the claim also recites “immunological test” which is the narrower statement of the range/limitation as it is interpreted to be specific for SARS-CoV-2, as discussed in section 7. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. The presence of multiple interpretations renders the claims indefinite.
Claims 2 and 4-11, which depend on claim 1, are similarly rejected.
11. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
12. Claim 1-2 and 4-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for SARS-CoV-2, does not reasonably provide enablement for all viruses. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Claim 1 recites “a method for in vitro diagnosis of a viral infection due to presence of a virus…” . Page 12 of the Instant Specification states that the invention can be used to detect any viral infection, however, page 14 states that the antibodies/antigens and immunological test are specific for SARS-CoV-2. In addition, the working examples provided only show immunological testing for SARS-CoV-2. Therefore, it would not be enabled that a SARS-CoV-2-specific test would be able to detect any and all types of viruses as broadly as currently recited.
Claims 2 and 4-11, which depend on claim 1, are similarly rejected.
13. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
14. Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 7 recites that the “immunological test comprises at least one antibody bonding to at least one antigen specific for said virus”, which does not further limit claim 1 as “detecting at least one antigen specific for said virus by means of an immunological test” would inherently require an antibody since the immunological test on page 14 is defined to have such an antibody. Thus, claim 7 does not further limit the claim on which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form so long as no duplicates are made, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
15. Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 10 recites that the “immunological test comprises at least one antibody bonding to at least one antigen specific for the SARS-CoV-2 coronavirus”, which does not further limit claim 9 as “an immunological test comprising at least one antibody binding to at least one antigen specific for the virus” would already be specific for SARS-CoV-2 as discussed on page 14 and in the claim interpretation section above. Thus, claim 10 does not further limit the claim on which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form so long as no duplicates are made, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
16. 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.
17. Claims 1-7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Laderman (US 20230204581 A1; provisional filed in 2020) (See PTO-892: Notice of References Cited) in view of Chen (Emerg. Microbes Infect., 14 June 2020, 9(1): 1356-1359) (See PTO-892: Notice of References Cited) and Dhand (Am. J. Respir. Crit. Care Med., 01 September 2020, 202(5): 651-659) (See PTO-892: Notice of References Cited).
Regarding claims 1, 3, and 6-7, Laderman teaches “The present disclosure provides compositions and methods for the rapid detection of coronavirus, and in particular, SARS-CoV-2 antigens in a biological sample.” (¶ [0007]) and “In certain aspects, the invention relates to a method for detecting nucleic acids or polypeptides with a flow strip as defined herein, e.g. (lateral) flow tests or (lateral) flow immunochromatographic assays.” (¶ [0172]). In addition, Laderman teaches the various sample types for SARS-CoV-2 immunological tests specifically in humans: “In one embodiment described herein, a sample (e.g., a biological sample) is loaded onto a sample pad. […] selected from the group consisting of an oral sample, saliva, blood, blood plasma, blood serum, nasopharyngeal fluid, amniotic fluid, breast milk, vaginal secretions, semen, seminal fluid, urine, amniotic fluid, cerebrospinal fluid, nasal fluid, bronchoalveolar lavage fluid, tears, mucous, tissue, tissue homogenate, cellular extract, spinal fluid, fecal specimen and any combination of two or more of the foregoing. […] In some embodiments, the sample is taken from a human using a swab (e.g., a nasal swab or a throat swab).” (¶ [0105]). In addition, it is clear that the antibodies are SARS-CoV-2 specific, as Laderman further teaches “The sandwich-format lateral flow immunoassay is performed with one anti-SARS-CoV-2 IgG antibody conjugated to a reporter particle and a second anti-SARS-CoV-2 antibody immobilized on nitrocellulose membrane to serve as a capture reagent. In this assay, the functionalized reporter particle binds to a specific epitope of nucleocapsid protein in the tested sample and, upon crossing the test line on the lateral flow strip, binds to the capture antibody.” (¶ [0189], Example 4: Rapid Detection of SARS-CoV-2 Antigen in Oral Fluid/Saliva Sample). In addition, Table 2 discloses the different antibody pairs that can be used (Page 26).
Laderman does not disclose all the aspects of the claimed invention in one aspect nor the secretions from the anterior nasal vestibule. Chen teaches “Briefly, patients were asked to cough up saliva by clearing the throat and spit about 1 mL of posterior oropharyngeal saliva directly into a sterile bottle” (Sample Collection), which reads on secretions from the anterior nasal vestibule as described in the Instant Specification: the sample must originate from the nasal vestibule, either by swabbing the nostril or having the individual sniff or clear their throat prior to sampling. Since Chen teaches having the patient clear their throat before sampling, the sample reads on secretions from the anterior nasal vestibule. In addition, Dhand teaches “Large respiratory droplets containing pathogens like influenza can travel approximately 6 feet when a sick person coughs or sneezes.” (Cough, ¶ 6), which is further supported by Figure 2 that states: “Airborne viral droplets are coughed, sneezed, or expelled by humans.”. Dhand also teaches that “At the time of writing, the World Health Organization’s opinion is that SARS-CoV-2 is transmitted by respiratory droplets and by contact” (Airborne Transmission of Respiratory Viruses by Cough, ¶ 3). Therefore, the nasal fluid from the nasal vestibule would predictably contain virus as said vestibule is involved in the sneezing mechanism. One of ordinary skill in the art would have a reasonable expectation of success in using nasal swabs to get fluid from the nasal vestibule, including the anterior part, and the sample containing virus for detection. Combining this sample with other sample types, such as saliva, would also be predictable as Laderman discloses saliva as a sample type, as well as combinations of sample types (¶ [0105]).
Therefore, it would have been obvious to one of ordinary skill at the time of filing to take the teachings and sample collection methods of Laderman and combine them to make an immunochromatographic assay to detect SARS-CoV-2 antigens in the biological sample as described by Chen and Dhand. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.). A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02). One of ordinary skill would also know to combine the sample types as Laderman discloses “and any combination of two or more of the forgoing.” (¶ [0105]). In addition, the teachings of Laderman, Chen, and Dhand are all focused on viral load in SARS-CoV-2 samples and "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (See MPEP § 2144.06(I)). One of ordinary skill in the art would have had a reasonable expectation of success for combining the different aspects of Laderman with the biological sample collected of Chen and Dhand to arrive at the invention as claimed. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Regarding claim 2, Laderman further teaches the various sample types as discussed above, which includes saliva, nasal fluid, nasopharyngeal fluid, mucus, and bronchoalveolar lavage fluid. Page 11 of the Instant Specification defines that the expectorations are from the bronchi.
Regarding claims 4-5, Laderman further teaches “The method comprises the steps of a) dispersing a biological sample suspected of having a SARS-CoV-2 antigen in a sample buffer” (¶ [0016]). Since it is suspected of having the virus, this step is done before the obvious detection step.
Regarding claims 9-10, Laderman further teaches “The present disclosure also provides compositions and methods for the simultaneous or discrete rapid detection of coronavirus (e.g., SARS-CoV-2) and influenzavirus, in a single test kit.” (¶ [0007]). The saliva and anterior nostril samples were discussed above in claim 1, as well as the swabs needed to take the samples, the antibodies, and the immunological test. Regarding the reagents necessary for implementing the test, Laderman teaches a conjugated reaction buffer and a conjugated block buffer for the immunoassay, as well as the other components of the immunoassay in Table 1 (Page 25, Example 4: Rapid Detection of SARS-CoV-2 Antigen in Oral Fluid/Saliva Sample). Laderman does not teach a medical device for collecting the samples. However, Chen teaches spitting directly into a sterile bottle (Sample Collection). The obvious method would require: the swabs, sterile bottle, antibodies, immunological test, and the reagents, and in view of the suggestion of Laderman, it would have been obvious before filing of the instant application to put all these required materials into a kit for ease of use and is standard practice in this art.
18. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Laderman (Supra), Chen (Supra), and Dhand (Supra) as applied to claims 1-7 and 9-10 above, and further in view of Abbott (Abbott, 16 December 2020, accessed online on 26 January 2026) (See PTO-892: Notice of References Cited).
Regarding claim 8, the combination of Laderman, Chen, and Dhand makes claim 1 obvious. Claim 8 depends on claim 1 but adds an age range to the human patient. Laderman does not teach the specific age of the individual from which the biological specimen originates from. However, Abbott teaches “In an interim, ongoing analysis of data collected in the U.S. from four investigational sites – where people tested themselves or a child – on a total of 52 people ranging from less than one-year-old to 63 years of age…” (BinaxNOW at-home performance data). Therefore, it would have been obvious to one of ordinary skill before the time of filing to take the obvious method of Laderman and Chen and apply them to a person older than 3.
19. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Laderman (Supra), Chen (Supra), Dhand (Supra), and Abbott (Supra) as applied to claims 1-10 above, and further in view of Terranova (Int. J. Mol. Sci. 2018, 19(10), 3256) (See PTO-892: Notice of References Cited).
Regarding claim 11, the combination of Laderman, Chen, and Dhand renders obvious claim 5 on which claim 11 depends. None of these references teaches a fluidising agent based on N-acetylcysteine or dithiothreitol. However, Terranova teaches “The reactive sulphydryl groups of DTT have a mucolytic function and are used to reduce mucoprotein disulfide bonds. DTT is commonly used in standard microbiology to homogenize sputum samples, enhancing the isolation of microorganisms, and has been also adopted in different studies for microbiota analysis” (3. Discussion, ¶ 3).
Therefore, it would have been obvious to one of ordinary skill at the time of filing to take the methods of Laderman, Chen, and Dhand, and further use a fluidising agent/sample buffer based on DTT because of its mucolytic function. A rationale to support a conclusion that a claim would have been obvious is that there is some teaching, suggestion, or motivation in the prior art or in the knowledge generally available to one of ordinary skill in the art to modify the reference or combine reference teachings, and the modification or combination would have a reasonable expectation of success. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, G. and 2143.02). One of ordinary skill in the art would have had a reasonable expectation of success for using a sampling buffer with DTT with the immunological test of Laderman, Chen, and Dhand to arrive at the invention as claimed. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Conclusion
20. No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA E LY whose telephone number is (571)272-5169. The examiner can normally be reached Monday - Thursday, 8:00 am - 5:00 pm EST.
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/KRISTINA E. LY/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671