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
2. Claims 1-20 are under consideration.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 17 January 2025 was filed after the mailing date of the instant application on 01 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.
Drawings
4. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
5. Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
6. Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because the "Sequence Listing" part of the disclosure submitted as a PDF file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)) is not the same as the CRF of the "Sequence Listing" as required by 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii).
Required response - Applicant must provide:
A replacement "Sequence Listing" as described above in items 1) c) or d) in accordance with 37 CFR 1.825(b)(1)(ii) or (iii); as well as
An amendment specifically directing its entry into the application as required by 37 CFR 1.825(b)(2)(ii);
A statement that identified the locations of any deletions, replacements or additions to the “Sequence Listing” as required by 37 CFR 1.825(b)(3);
A statement that the "Sequence Listing" added by amendment includes no new matter as required by 37 CFR 1.825(b)(5);
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4); and
A statement that the content of the previously-filed CRF is identical to the "Sequence Listing" part of the disclosure added by amendment as required by 37 CFR 1.825(b)(7), where provided under item 1) c) or d) (note that where a "Sequence Listing" part of the disclosure is provided under item 1) a) or b), the text file will also serve as the CRF, and the statement of identity is not required);
OR
A CRF as required by 37 CFR 1.821(e)(1) or 1.821(e)(2); and
A statement that the content of the CRF is identical to the "Sequence Listing" part of the disclosure previously submitted as a PDF file (37 CFR 1.821(c)(2)) or on physical sheets of paper (37 CFR 1.821(c)(3)), as required by 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii).
Please see SEQ ID NO: 3 in the CRF, wherein the listing contains no information.
Specification
7. The disclosure is objected to because of the following informalities: the numbering of the tables is out of order. Appropriate correction is required.
8. 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:// or other browser-executable code. See MPEP § 608.01. Please see:
Page 23, ¶ 1
Page 31, ¶ 1
Page 37, ¶ 3
Page 77, ¶ 1
Page 78, ¶ 1
Note that these are merely examples and all improper uses of hyperlinks in the specification should be identified by Applicant and properly addressed.
9. The use of the terms: ‘iSeq’ (page 23, table 5 description; page 28, table 3), ‘MiSeq’ (page 29, table 3), ‘AMPure’ (page 36, ¶ 1), ‘Nextera’ (page 36, ¶ 1), ‘NCBI’ (page 37, ¶ 4), ‘SMRTbell’ (page 63, ¶ 1), ‘PacBio’ (page 63, ¶ 1), Kingfisher (page 71, ¶ 2), and ‘QIAcuity’ (page 72, ¶ 4), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Note that these are merely examples and all improper uses of trademarks in the specification should be identified by Applicant and properly addressed.
Claim Objections
10. Claims 4-5, 12-13, and 19 are objected to because of the following informalities:
Regarding claim 4, ‘RBD’ needs to be defined
Regarding claim 12, the first instance of ‘RT-PCR’ needs to be defined
Regarding claim 5, ‘a’ should be inserted after ‘testing’
Regarding claim 13, ‘the’ should be inserted after “prior to”
Regarding claim 19, ‘the’ should be inserted after ‘identify’
Appropriate correction is required.
Claim Interpretation
11. According to the instant specification, the terms ‘a’, ‘an’, and ‘the’ are hereby interpreted to mean “one or more” (Page 19, ¶ 1) and ‘or’ is hereby interpreted to mean ‘and/or’ (Page 20, ¶ 4). In addition, it is interpreted that the SEQ ID NOs require the full length of the sequence as listed without any additions/mutations/substitutions in between, but can have base pairs before/after, as long as the prior art reads on a primer.
The term ‘cryptic lineages’ will be interpreted according to the definition in the instant application: “These cryptic lineages are viral sequences that contain a combination of mutations that are rarely observed in currently circulating viral variants or clinical samples.” (Page 2, ¶ 3). “Each sequence with a unique combination of amino acids changes is referred to as a lineage… Amino acid combinations identified that have not been seen previously from patients are referred to as cryptic lineages. Cryptic lineages are those sequences identified in at least two independent samples. Cryptic lineages may comprise one or more non-synonymous substitutions, insertions, and/or deletions.” (Page 13, ¶ 4).
Claim Rejections - 35 USC § 112
12. 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.
13. Claims 1-20 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.
The term ‘prolonged’ in claim 1 is a relative term which renders the claim indefinite. The term ‘prolonged’ is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Additionally, it is unclear whether if “sequencing the variable regions of viral RNA” is an optional step as it requires wastewater, whereas the sample could be urine or stool instead.
Claims 2-20, which depend on claim 1, are similarly rejected.
Claim 1 recites the limitation "the variable regions". There is insufficient antecedent basis for this limitation in the claim. A suggested change would be to remove the ‘the’.
Claims 2-20, which depend on claim 1, are similarly rejected.
Claim 4 recites the limitation “the variable region” whereas claim 1 recites “the variable regions”. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the antigen" and “the Spike or membrane protein”. There is insufficient antecedent basis for this limitation in the claim.
Claim 4, which depends on claim 1, is similarly rejected.
Claim 5 recites the limitation “recombinant virus”. There is insufficient antecedent basis for this limitation in the claim.
Claims 6-8, which depend on claim 5, are similarly rejected.
Regarding claim 12, it is unclear if “comprising SEQ ID NO: 6 or 16 and 7” means “SEQ ID NO: 6 and 7 or SEQ ID NO: 16 and 7” or “SEQ ID NO: 6 by itself or SEQ ID NO: 16 and 7”. For purposes of compact prosecution, Examiner is interpreting this limitation to mean “SEQ ID NO: 6 and 7 or SEQ ID NO: 16 and 7”.
Claims 13-14, which depend on claim 12, are similarly rejected.
The term ‘concern’ in claim 18 is a relative term which renders the claim indefinite. The term ‘concern’ is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 101
14. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
15. Claims 1-13 and 15-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite ‘identifying’, ‘analyzing’, and ‘determining’. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. See MPEP 2106 for analysis framework.
The instant claims are drawn to a method with steps to identify antigenic variants, identify cryptic lineages, analyzing cryptic lineages, and determining if the antigenic variants become variants of concern. As such, the instant claims are drawn to a process, which is statutory category of matter (Step 1: Yes).
The instant claims are drawn to a judicial exception of an abstract idea, more specifically a mental process. The step of assessing could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). Thus, the claim is directed to at least one exception, which may be termed as an abstract idea (Step 2A, Prong 1: Yes). The instant claims are drawn solely to a judicial exception which is not integrated into a practical application with sufficient particularity because the claimed invention is not used to provide a particular treatment or prophylaxis for a disease or medical condition. Further, the claimed invention does not apply or use the judicial exception in a meaningful way and there is no inventive concept in the claims. Generally linking the use of the judicial exception to a particular technological environment or field of use, such as the study of viral lineages, is not indicative of integration into a practical application (see MPEP 2106.05(h) and Example 29, Claim 2 (Diagnosing and Treating Julitis) of the Subject Matter Eligibility Examples: Life Sciences found at https://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf)). Therefore, the instant claims do not recite any additional elements that integrate the exception into a practical application (Step 2A, Prong 2: No).
The instant claims are drawn to a judicial exception and do not recite any additional elements that amount to significantly more than the judicial exception (Step 2B: No).
In view of the foregoing, the instant claims do not constitute patent eligible subject matter under 35 U.S.C. § 101.
16. Claim 14, which reads on a method drawn to an abstract idea, is not being rejected as SEQ ID NO: 26 is clear and free of the prior art. Thus, making it patent eligible subject matter as the claim recites additional elements that amount to “significantly more” than the judicial exception (Step 2B: Yes).
Claim Rejections - 35 USC § 102
17. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
18. Claims 1-8, 12-13, and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smyth (medRxiv, 26 July 2021) (See IDS filed 17 January 2025).
Regarding claims 1-3 and 19, Smyth teaches “Wastewater was collected from the inflow at 14 NYC wastewater treatment plants and RNA isolated according to our previously published protocol.” (Wastewater Sample Processing and RNA Extraction, ¶ 1) and “To monitor New York City (NYC) for the presence of novel variants, we amplified regions of the SARS-CoV-2 Spike protein gene from RNA acquired from all 14 NYC wastewater treatment plants (WWTPs) and ascertained the diversity of lineages from these samples using high throughput sequencing. Here we report the detection and increasing frequencies of novel SARS-CoV-2 lineages not recognized in GISAID’s EpiCoV database.” (Abstract). In summary, Smyth collected wastewater, extracted the RNA, sequenced the Spike protein region of SARS-CoV-2, and used a database to determine which lineages were previously unidentified, as claimed.
Regarding claim 4, Smyth further teaches “Our targeted sequencing strategy entailed iSeq 100 and MiSeq sequencing of PCR-amplified regions of the SARS-CoV-2 Spike protein gene, particularly the receptor binding domain (RBD).” (Main, ¶ 1).
Regarding claims 5-8, Smyth further teaches “To test if the WNY lineages have gained resistance to neutralizing antibodies, we obtained three clinically approved neutralizing monoclonal antibodies representing these 3 classes, LY-CoV016 (etesevimab, Class 1)43, LY-CoV555 (bamlanivimab, Class 2)44, and REGN10987 (imdevimab, Class 3)45, and tested their ability to neutralize the WNY lineages. All four of the WNY lineages displayed complete resistance to LY-CoV555, despite the parent lineage remaining potently sensitive to this antibody (Fig.3). The WNY 1 and 2 remained at least partially sensitive to LY-CoV016 and REGN10987, but WNY 3 and 4 appeared to be completely resistant to all three neutralizing antibodies (Fig. 3).” (Lineages Detected from Wastewater Are Resistant to Some Neutralizing Antibodies, ¶ 2) and “Transfections of 10cm dishes of 293FT cells were performed 5 mg each of heavy and light chain vectors and 40 mg polyethyleneimine (PEI).” (Monoclonal antibody synthesis, ¶ 1). In summary, Smyth teaches an antibody neutralization assay (See Antibody Neutralization Assay section) to test the viruses and generated monoclonal antibodies that were somewhat capable of recognizing and neutralizing the variants, as claimed.
Regarding claims 12-13, Smyth teaches SEQ ID NO: 6-9 (Table 1), where:
SEQ ID NO: 6 (‘Qy’) corresponds to the forward primer (‘Db’) of “MiSeq RBD primary PCR primers (SARS-CoV-2 spike receptor binding domain)” and
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SEQ ID NO: 7 (‘Qy’) corresponds to the reverse primer (‘Db’).
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SEQ ID NO: 8 (‘Qy’) corresponds to the forward primer (‘Db’) of “MiSeq RBD Nested PCR primers - (SARS-CoV-2 spike receptor binding domain)” and
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SEQ ID NO: 9 (‘Qy’) corresponds to the reverse primer (‘Db’).
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Smyth also teaches “The primary RBD RT-PCR was performed using the Superscript IV One-Step RT-PCR System (Thermo Fisher Scientific). Primary RT-PCR amplification was performed as follows: 25°C(2:00) + 50°C(20:00) + 95°C(2:00) + [95°C(0:15) + 55°C(0:30) + 72°C(1:00)] x 25 cycles using the MiSeq primary PCR primers (Table 1).” (Targeted PCR, ¶ 3).
Regarding claim 18, Smyth teaches “Thus, the characteristics of these variant lineages provide them the capacity to be an increased threat to human health.” (Lineages Detected from Wastewater Are Resistant to Some Neutralizing Antibodies, ¶ 3).
Claim Rejections - 35 USC § 103
19. 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.
20. Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Smyth (medRxiv, 26 July 2021) (See IDS filed 17 January 2025) as applied to claim 1 above, and further in view of Meinke (US 20240293531 A1; 06 April 2021) (See PTO-892: Notice of Reference Cited).
Regarding claims 9-11, Smyth teaches the limitations of claim 1 in section 18 above. Smyth does not teach an inactivated vaccine using more than one of the antigenic variants. However, Meinke teaches “The SARS-CoV-2 particles in the vaccine composition may be derived from any known strain of SARS-CoV-2, or variants thereof. […] As described herein, the inactivation process may result in modification (e.g. alkylation or acylation) and/or fragmentation of viral RNA, and thus it will be understood that the inactivated viral particles may not comprise an intact RNA sequence as defined herein, but rather are derived from native viral particles which do comprise such a sequence.” (¶ [0070]) and “In some embodiments, the inactivated SARS-CoV-2 particles are combined with other inactivated SARS-CoV-2 particles in the vaccine (other=other sequence).” (¶ [0081]).
Therefore, it would have been obvious to a person of ordinary skill before the effective filing date of the claimed invention to use the methods of Smyth and further use more than one identified antigenic variant in an inactivated viral vaccine, as discussed in Meinke. 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 in the art would have had a reasonable expectation of success for using the identified antigenic variants in an inactivated viral vaccine. 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.
21. Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Smyth (medRxiv, 26 July 2021) (See IDS filed 17 January 2025) as applied to claims 1 and 12 above, and further in view of Smyth2 (Nat. Commun., 03 February 2022, 13, 635) (See IDS filed 17 January 2025).
Regarding claims 15-16, Smyth teaches the limitations of claim 1 in section 18, as well as SEQ ID NO: 7 in claim 12. Smyth also teaches SEQ ID NO: 18 (‘Qy’), which is the end fragment of SEQ ID NO: 9 (‘Db’) in claim 12.
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Smyth does not teach that the primers amplify at least a 1.5 kb region encoding SARS-Cov-2 Spike protein. However, Smyth2 is the corresponding journal article published from Smyth and uses the same primers for RT-PCR, but discloses: “In addition, we are PCR amplifying, cloning, and sequencing a 1.5 kb region of the spike protein gene to confirm the linkage of mutations of interest.” (Challenges, ¶ 4).
22. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Smyth (medRxiv, 26 July 2021) (See IDS filed 17 January 2025) and Smyth2 (Nat. Commun., 03 February 2022, 13, 635) (See IDS filed 17 January 2025) as applied to claim 15 above, and further in view of Wohlstadter (US 20210349104 A1; EFD 30 April 2021) (See PTO-892: Notice of References Cited).
Regarding claim 17, Smyth and Smyth2 teach the limitations of claim 15 in section 21, but do not teach SEQ ID NO: 17. However, Wohlstadter teaches SEQ ID NO: 221 (‘Db’), a primer for detecting SARS-CoV-2, which corresponds to SEQ ID NO: 17 (‘Qy’) in the instant application:
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Therefore, it would have been obvious to one of ordinary skill in the art to take the primers in Smyth and further apply the primer in Wohlstadter in a nested amplification step. 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 in the art would have had a reasonable expectation of success for applying the primer in a nested amplification step. 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.
23. Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Smyth (medRxiv, 26 July 2021) (See IDS filed 17 January 2025) as applied to claim 1 above, and further in view of Dergham (J. Clin. Med., 18 June 2021, 10(12), 2696) (See PTO-892: Notice of References Cited).
Regarding claim 20, Smyth teaches the limitations of claim 1 in section 18 but does not teach extracting the RNA from fecal matter or urine. However, Dergham teaches “In this study, we attempted to isolate by cell culture SARS-CoV-2 from stool samples received in our laboratory at the IHU Méditerranée Infection for patients suffering from COVID-19. […] The E gene of SARS-CoV-2 was amplified through RT-PCR…” (Materials and Methods, ¶ 1) and “In this work, we sought to determine whether the SARS-CoV-2 RNA positive stool contained infectious virus and then whether the stool could be a source of transmission.” (Discussion, ¶ 1). Therefore, it would have been obvious to one of ordinary skill in the art to take the methods of Smyth and further substitute the extracted RNA from feces as done in Dergham over the wastewater samples. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.). One of ordinary skill in the art would have had a reasonable expectation of success for substituting extracted fecal RNA over extracted RNA from wastewater. 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.
Allowable Subject Matter
24. Regarding claim 14, Brambati (US 20210340636 A1; Filed 13 July 2021) (See PTO-892: Notice of References Cited) teaches SEQ ID NO: 56 (‘Db’), a primer used for detecting SARS-CoV-2, which corresponds to SEQ ID NO: 25 (‘Qy’) of the instant application:
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SEQ ID NO: 8 and SEQ ID NO: 18 are found in the prior art, as discussed above in sections 18 and 21, respectively. However, while SEQ ID NO: 26 (‘Query’) reads on part of a naturally-occurring SARS-CoV-2 sequence (‘Sbjct’) (Nucleotide Accession: OV549208.1; Uploaded 17 January 2022) (See PTO-892: Notice of References Cited), that specific fragment used as a primer is free and clear of the art.
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Conclusion
25. No claim is 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.
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, Janet Andres can be reached at (571)-272-0867. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTINA E. LY/Examiner, Art Unit 1671
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672