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 .
Election/Restrictions
Applicant’s election of Group I, Species of method of claim 1, part [B], for detecting a viral antigen (claim 5) with an antibody mimetic (claim 7) in the reply filed on February 12, 2026 is acknowledged. Claims 1, 4, 6-7 and 18-20 are currently under examination. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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 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 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.
Claim(s) 1, 6-7, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ju (WO 2020/023405) in view of “Ju 2015” (US 2015/0111759).
Regarding claim 1[B], Ju teaches a method of determining the presence of an antigen in an environmental or biological sample ([Abstract]: methods to detect compounds (analytes) utilizing antibodies and nanopore-detectable tags using specially designed nanopores; p. 2, ll. 22-23: to detect antigens; p. 34, l. 17: e.g., blood, urine) comprising:
(a) contacting the environmental or biological sample potentially comprising the antigen with an antibody mimetic (p. 8, ll. 12-13: antibodies can be replaced by antibody mimetics) with high affinity and specificity for said antigen (p. 3, ll. 3-5: step (a); ll. 10-11, step (c)), wherein said antibody mimetic is covalently attached to a polymer tag (p. 22, last para.: the tag comprises a polymeric molecule) to produce a polymer-tagged antibody mimetic (p. 3, l. 12: step (d): a tagged compound),
(b) introducing the resulting polymer-tagged antibody mimetic obtained in (a) to a device comprising one or more nanopores (p. 3, ll. 4-5: step (a): a nanopore),
(c) applying a voltage gradient across the one or more nanopores (p. 3, ll. 17-19: step (e)), in order to draw the polymer tag into the one or more nanopores (p. 3, ll. 21-22: step (f): at least one tag of the tagged compound entering the nanopore; further, this limitation is the intended result of the “applying” step and does not further limit the method as claimed because it does not require steps to be performed; in method claims, it is the overall method steps that are given patentable weight not the intended result; MPEP 2111.04),
(d) measuring the current in the one or more nanopores (p. 3, ll. 20-22: step (f)), wherein a continuous current blockade indicates binding of the antigen to the polymer-tagged antibody mimetic, and wherein absence of a continuous blockade current indicates absence of binding of the antigen to the polymer-tagged antibody mimetic (here, this limitation would naturally occur in the measured current in the claimed method and does not further limit the method as claimed because it does not require steps to be performed; in method claims, it is the overall method steps that are given patentable weight not the intended result; MPEP 2111.04),
thereby determining the presence or absence of viral antigens in the sample (p. 3, l. 23).
Ju does not disclose wherein the resulting polymer-tagged antibody mimetic has substantially smaller dimensions than said antigen or wherein the diameter of one or more nanopores is larger than the dimensions of the polymer-tagged antibody mimetic, but smaller than the dimensions of the antigen.
However, Ju 2015 teaches sequencing nucleic acids using nucleotide analogues and translocating of tags from incorporated nucleotide analogues through a nanopore ([Abstract]). The nanopore has various types, and a suitable nanopore may be selected based on various characteristics of the analyte molecule such as the size of the analyte molecule in relation to the pore size of the nanopore (¶167), which renders the nanopore diameter a result-effective variable.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ju by adjusting the diameter of the nanopore so that it larger than that of antigen but smaller than that of the tagged compound as claimed because the nanopore diameter is a result-effective variable and can be optimized through routine experimentation. MPEP 2144.05 (II)(B).
Regarding claim 6, Ju teaches wherein in [B], the device comprising one or more nanopores comprises an array of nanopores (Fig. 16; p. 15, l. 8: nanopore array).
Regarding claim 7, Ju teaches wherein in [B], the antibody mimetic comprises an affibody (p. 21, para. 2: affibody).
Regarding claim 18, Ju teaches wherein the polymer-tagged antibody mimetic comprise oligonucleotide tags (p. 10, l. 12: an oligonucleotide tag).
Regarding claim 20, Ju and Ju 2015 discloses all limitations of claim 1, but fail to teach wherein the oligonucleotide tags have different diameters for multiplex determination of viral antigens.
However, the fact that different oligonucleotide tags have different diameters does not further limit the method as claimed because it does not require steps to be performed and in method claims it is the overall method steps that are given patentable weight not the intended result. MPEP 2111.04. As described in claim 1, Ju 2015 teaches sequencing nucleic acids using nucleotide analogues and translocating of tags from incorporated nucleotide analogues through a nanopore ([Abstract]). The nanopore has various types, and a suitable nanopore may be selected based on various characteristics of the analyte molecule such as the size of the analyte molecule in relation to the pore size of the nanopore (¶167), which renders the nanopore diameter a result-effective variable.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ju and Ju 2015 by selecting the oligonucleotide tags with different diameters as appropriate corresponding to the diameter of the nanopore because the nanopore diameter is a result-effective variable and can be optimized through routine experimentation for different oligonucleotide tags with different diameters for the claimed method of determining the presence of viral antigen. MPEP 2144.05 (II)(B).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ju in view of Ju 2015, and further in view of Lewandowski (K. Lewandowski, Metagenomic Nanopore Sequencing of Influenza Virus Direct from Clinical Respiratory Samples, J. Clinical Microbiology, 2020(58), e00963-19, pp. 1-15).
Regarding claim 4, Ju and Ju 2015 discloses all limitations of claim 1, but fail to teach wherein in [B], the antigen is a viral antigen, wherein the viral antigen comprises an antigenic protein of SARS-CoV-2, SARS-CoV, MERS, influenza A, influenza B, HIV-1, HBV, HCV and Ebola virus, and the polymer-tagged antibody mimetic comprises an antibody mimetic with high affinity and specificity for an antigenic protein of SARS-CoV- 2, SARS-CoV, MERS, influenza A, influenza B, HIV-1, HBV, HCV and Ebola virus.
However, Lewandowski teaches using the nanopore platform for diagnosis and genetic analysis of influenza virus and other respiratory viruses ([Abstract]), as shown as nanopore sequencing for influenza virus (Fig. 1). The influenza virus includes influenza A or B virus (p. 2, last line).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ju and Ju 2015 by applying the claimed method to detecting the presence of the antigen, e.g., the viral influenza A or B antigen, as taught by Lewandowski because nanopore technology is suitable for sequencing the influenza virus. Here, the claimed limitations are obvious because 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 yielded nothing more than predictable results. MPEP 2143(I)(A).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ju in view of Ju 2015, and further in view of Wohlstadter (US 2021/0349104).
Regarding claim 19, Ju and Ju 2015 discloses all limitations of claim 18, but fail to teach wherein the oligonucleotide tags comprise single stranded, double stranded, hairpin, triplex or quartet DNA molecules.
However, Wohlstadter teaches detecting a coronavirus using an oligonucleotide tag, which comprises a single-stranded oligonucleotide (¶524).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Ju and Ju 2015 by substituting the oligonucleotide tag with a single-stranded one as taught by Wohlstadter. The suggestion for doing so would have been obvious because the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07. Here, the substitution of one known element for another would yield nothing more than predictable results. MPEP 2141(III)(B).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLYN M SUN whose telephone number is (571)272-6788. The examiner can normally be reached M-F: 8:30am - 5:30pm.
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, Luan Van can be reached on 571-272-8521. 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.
/C. SUN/Primary Examiner, Art Unit 1795