DETAILED ACTION
Applicant's response, filed 07/02/2026, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 1-17 and 20 are rejected.
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 .
Drawings
The drawings filed on 11/09/2022 are accepted.
Priority
This application is a 371 of application # PCT/US21/32538, filed 05/14/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. This application claims Domestic Benefit to provisional application #63/025,402, filed 05/15/2020. Domestic Benefit is acknowledged. Therefore, the effective filing date of claim(s) is 05/15/2020.
Information Disclosure Statement
The Information Disclosure Statement filed on 11/09/2022 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of list of references cited from each IDS is included with this Office Action.
Claim Objections
Claims 18 and 19 were objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
Claim(s) 1-11, 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Chee et al. (WO2019089836A1, henceforth “Chee”, newly cited) in view of Lopez et al. (NATURE COMMUNICATIONS, (2019) 10:2933) (henceforth “Lopez”, previously cited).
Regarding claim 1, Chee encodes protein binding event information in a nucleic acid chain (called a “recording tag”). The recording chain has a plurality of “encoder sequences” or codons (which encode a binding event) separated by spacer segments (addresses) (¶ 35) which distinguish the different events. Chee discloses sequencing the recording tag in a nanopore sequencer to read the protein binding events comprises using oligonucleotides complementary to the spacers (blockers) ([¶ 1221]). The duplexes formed by the probes bound to the spacers become transiently stalled at the constriction zone of the nanopore enabling a current readout of about three bases adjacent to the duplex region (the “codons”) ([¶ 1221]). Chee explains the stalling allows for more accurate encoder sequence readout.
Chee is silent to reading stored data using this method.
Lopez teaches translating measured currents into an output signal representative of stored data (abstract).
Regarding claims 2 and 3, a second current is measured after the dissociation in Chee, followed by a third current for the second codon (¶ 846).
Regarding claim 4, repeated patterns are used for repeated codons (¶ 846).
Regarding claim 5, the first current of the first codon has a current associated with the nucleotides of the first codon (¶ 846).
Regarding claims 6-8, Chee states that the stalling enables a current readout of “about” three bases. Two to five bases are within the scope of “about three” bases.
Regarding claim 9, Chee states that their method could be used for identification of a biomarker (¶ 1061).
Regarding claim 10, Chee states that a native nucleic acid could be used (¶ 1073).
Regarding claim 11, Chee’s method is enzyme-free and vectorial in that it occurs in a linear direction (¶ 1221).
Claim 15 is similar to claim 1, with an added limitation such that some of the data read in the “codons” precede the nucleotides bound with the blocker. The spacers of Chee can be binding agent specific, cycle specific, etc., such that the spacer/address includes “coding sequences”, and thus the blocker binds an address and information within a coding window (¶ 35).
Regarding claim 16, an equal coding window size and sequence is taught by Chee (¶ 1221).
Regarding claim 17, the spacers act as the addresses with address sequences (¶ 35).
Regarding claims 1-11, 15-17, An invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some teaching, suggestion, or motivation in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. There is a teaching to use the encoder sequences, spacer segments, and complementary oligonucleotides in the text of Chee, because it provides improved reading accuracy of the encoding sequence that stores information (¶ 1221). There would be a
reasonable expectation of success in making this combination to a person of ordinary skill in the art, because both Chee and Lopez are related to reading encoded sequences that store information. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time to modify the method of Chee by adapting it to be primarily for data storage as in Lopez, in order to provide improved reading accuracy of the encoding sequence that stores information (¶ 1221).
Claims 12-14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Chee and Lopez as applied to claims 1-11, 15-20 above, and further in view of Gu et al. (U.S. Patent No. 9,732,379) (henceforth “Gu”, previously cited) and Khan Academy (“Converting Analog data to binary”, 2020, https://www.khanacademy.org/computing/computers-and-internet/xcae6f4a7ff015e7d:digital-information/xcae6f4a7ff015e7d:representing-analog-data-in-binary/a/converting-analog-data-to-binary) (henceforth “Khan”, previously cited).
Concerning claim 12, Gu’s specification col 7 line 8 states that a charge of 120 mv is applied.
Regarding claims 13-14, Gu is silent as to the form of the output signal.
Khan teaches converting analog data into binary data (¶ 1). Khan suggests other types of bit encoding exist, such as quaternary. (¶ 7).
Concerning the kit of claim 20, the concept of a kit and the “blocker” or probe molecules are taught by claims 1-2 of Gu.
The universal nucleic acid chain is taught by figure 1 of Gu. The figure shows more than three nucleotides about to pass through the nanopore, comprising the coding windows. The address sequences are equivalent to the spacers of Chee (¶ 35).
The microfluidic device with inlet, nanopores, and a measuring device that measures current is taught by fig. 4 of Gu, which shows inlets, multiple nanopores, and a graph of the current through the nanopore. The measuring device is described in column 4, lines 29-34 of Gu’s specification.
Regarding claims 12-14, An invention would have been prima facie obvious to one of ordinary
skill in the art at the time of the effective filing date of the invention if some teaching, suggestion, or motivation in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. There is a teaching to use binary data, and a suggestion to use other bit encodings, in the text of Khan. There would be a reasonable expectation of success in making this combination to a person of ordinary skill in the art, as there is nothing stopping the analog electric signal data of the invention from being converted to binary or quaternary. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time to modify the method of Gu by converting the output data to binary, in order to make the data computer readable.
Regarding claims 12-14 and 20, An invention would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date of the invention if some teaching, suggestion, or motivation in the prior art would have led that person to combine the prior art teachings to arrive at the claimed invention. There is a teaching to use the microfluidic device, kit, and specific signals in the text of Gu and Khan, in order to improve the computer readability of the data. There would be a reasonable expectation of success in making this combination to a person of ordinary skill in the art, as all methods are related to information being encoded onto a nucleic acid strand. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time to modify the method of Chee and Lopez by integrating it with the specifics of Gu and Khan, in order to in order to improve the computer readability.
Response to Arguments - 35 USC § 103
Applicant’s arguments, see page 6 ¶ 2, filed 07/02/2026, with respect to the rejections of claims 1-20 under 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection
has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Chee.
Conclusion
35 U.S.C. § 101 was considered in the examination of this case, but the invention was found to contain eligible subject matter. While the independent claims are directed to processes (STEP 1: Yes), and are directed to an abstract idea (“measuring a first current” in claim 1, a mathematical relationship) (STEP 2A: Yes), the claims recite additional elements that, when considered in combination with the abstract idea, amount to significantly more than the judicial exception (‘the “applying an electric potential” that dissociates the blocker) (Step 2B: Yes).
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/G.M.H./Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685
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