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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 23 March 2026 has been entered.
Response to Amendment
Amendments to the claims filed on 23 March 2026 are acknowledged. Claims 1-3, 7-9, 19, and 20 are amended. At least claims 1 and 9 have been amended with improper mark-up. Claims 1-4, 7-9, 19, and 20 are pending and are presented for examination on the merits.
In response to the amendments filed on 23 March 2026, the objection to the specification is withdrawn; the objection to the claims is withdrawn; the rejections under 35 USC 112(b) are partially withdrawn and supplemented; and the rejections under 35 USC 112(a) regarding the written description requirement are maintained with modification. The rejections for anticipation by Wei ("N‑Terminal Derivatization-Assisted Identification of Individual Amino Acids Using a Biological Nanopore Sensor," ACS Sens. May 14, 2020) are maintained with modification.
The declaration under 37 CFR 1.132 filed 23 March 2026 is insufficient to overcome the rejection of the claims based upon Wei ("N‑Terminal Derivatization-Assisted Identification of Individual Amino Acids Using a Biological Nanopore Sensor," ACS Sens. May 14, 2020) as set forth in the last Office action. The declaration discusses the co-authors of Wei, X. et al. "Enabling nanopore technology for sensing individual amino acids by a derivatization strategy," J. Mater. Chem. B, 2020, 8, 6792-6797; which was first published on 26 May 2020, the filing date of the provisional application 63/029764. However, the rejection under 35 U.S.C. 102(a)(1) is based upon a different reference having a different set of co-authors. The declaration is silent regarding the following co-authors of "N‑Terminal Derivatization-Assisted Identification of Individual Amino Acids Using a Biological Nanopore Sensor": Jonathan L Gray, Libo Zhang, and Tianyu Zhu. Moreover, the record does not clearly establish whether the individuals discussed in the declaration are the same people as those co-authors of "N‑Terminal Derivatization-Assisted Identification of Individual Amino Acids Using a Biological Nanopore Sensor" having similar or identical names.
Title Warning
The title of the invention is not descriptive of the claimed invention ("…in Oligopeptides"). A new title is required that is clearly indicative of the invention to which the claims are directed. If a satisfactory title is not supplied by the applicant, the examiner may change the title on or after allowance. See MPEP 606.01.
Claim Rejections - 35 USC § 112
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.
Claims 1-4, 7-9, 19, and 20 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites the limitation "modifying at least one individual amino acid via reaction with at least one derivatization reagent to produce at least one modified individual amino acid." It is unclear whether the scope of the claim includes modifying a single individual amino acid via reaction with more than one derivatization reagent, which lacks written description support. The examiner suggests the limitation "modifying an individual amino acid via reaction with a derivatization reagent to produce a modified individual amino acid."
Claim 1 recites the limitation "at least one translocation signal characterized by current blockades and dwell times." It is unclear how a translocation signal(s) can be "characterized by" current blockades and dwell times. This does not appear to be the proper choice of English words to describe the desired concept. Claim 9 is indefinite for analogous reasons.
Claim 1 recites the limitation "identifying the at least one modified individual amnio acid via analysis of at least one translocation signal characterized by current blockades and dwell times generated during passage across the at least one nanopore biosensor." It is unclear whether the scope of the claim requires, if the at least one modified individual amnio acid is a single modified individual amnio acid, that plural dwell times are generated. Claim 7 is indefinite for analogous reasons.
Claim 1 recites the limitation "analysis of at least one translocation signal characterized by current blockades and dwell times generated during passage across the at least one nanopore biosensor." Passage of what?
Claims 2-4, 7-9, 19, and 20 are rejected under 35 USC 112(b) for inheriting the deficiencies of independent claim 1.
Claim 7 recites the limitation "wherein identifying the at least one individual amino acid is accomplished via …." There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "further comprising identifying the at least one modified individual amino acid via analyzing dwell times induced via the at least one modified amino acid." It is unclear whether this limitation further modifies claim1.
Claim 9 recites the limitation "the at least one modified individual ammo acid." There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "when the at least one modified individual [amino] acid translocates across the at least one nanopore biosensor." There is insufficient antecedent basis for this limitation in the claim. Claim 1 previously recites "passing the at least one modified individual amino acid across at least one nanopore biosensor."
Claim 20 recites the limitation "as the at least one modified individual amino acid passes through the at least one nanopore biosensor." There is insufficient antecedent basis for this limitation in the claim. Claim 1 previously recites "passing the at least one modified individual amino acid across at least one nanopore biosensor."
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.
Claims 1-4, 7-9, 19, and 20 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
The examiner respectfully reminds the Applicant that according to MPEP §2163:
"2163.02. Standard for Determining Compliance with Written Description Requirement:
The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, “does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed.” In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter.” Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)). Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the University of California v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharmaceutical, 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by “whatever characteristics sufficiently distinguish it”).
Independent claim 1 has been amended to recite the limitation "passing the at least one modified individual amino acid across at least one nanopore biosensor."
Dependent claims 9 and 20 recite related limitations.
The scope of claim 1 encompasses passing a single modified individual amino acid through plural nanopore biosensors. This is not supported by the original disclosure.
The original disclosure does not describe "biosensors" or the sequential passage of a single modified individual amino acid through more than one nanopore biosensor. In fact, Fig. 89 illustrates plural modified individual amino acids in a single nanopore.
The Applicants did not show possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention, by description of an actual reduction to practice, or by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention.
Dependent claims 2-4, 7-9, 19, and 20 are rejected for depending from independent claim 1.
Claim Rejections - 35 USC § 102
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.
Claims 1-4, 7-9, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wei ("N‑Terminal Derivatization-Assisted Identification of Individual Amino Acids Using a Biological Nanopore Sensor," ACS Sens. May 14, 2020; cited 03/24/2023 and previously relied upon).
This reference appears to be co-authored by the two joint inventors and ten non-inventors. It was published before, but within a year of, the filing dates of the instant application (March 25, 2021) and provisional application 63/029764 (May 26, 2020).
Regarding claim 1, Wei discloses a method for identifying individual amino acids (title) comprising:
modifying at least one individual amino acid via reaction with at least one derivatization reagent to produce at least one modified individual amino acid, wherein the at least one derivatization reagent is selected from the group consisting of o-phthalaldehyde (OPA), phenyl isothiocyanate (PITC), naphthalene isothiocyanate (NITC), and 2,3- naphthalenedicarboxaldehyde (NDA) (abstract, Fig. 1);
passing the at least one modified individual amino acid across at least one nanopore biosensor (abstract); and
identifying the modified individual amnio acid via passing the modified individual amino acid through at least one nanopore biosensor via analysis of at least one translocation signal characterized by current blockades and dwell times generated during passage across the at least one nanopore biosensor (abstract, Fig. 2).
Regarding claim 2, Wei discloses developing a characteristic translocation profile for the at least one modified individual amino acid via a statistical description of a translocation process of the at least one modified individual amino acid through the at least one nanopore biosensor (page 1709, right col.).
Regarding claim 3, Wei discloses analyzing current blockades and dwell times for the at least one individual amino acid within the at least one nanopore biosensor (Fig. 2).
Regarding claim 4, Wei discloses that the least one nanopore biosensor is an α-hemolysin nanopore (abstract).
Regarding claim 7, Wei discloses that identifying the at least one individual amino acid is accomplished via analyzing current blockades induced via presence of the at least one amino acid (Fig. 2).
Regarding claim 8, Wei discloses that identifying the modified individual amino acid is accomplished via analyzing dwell time induced via the at least one amino acid analyte (Fig. 2).
Regarding claim 9, Wei discloses generating a signal characterized by current blockades and dwell times when the at least one modified individual amino acid analyte translocates across the at least one nanopore (Fig. 2).
Regarding claim 19, Wei discloses that the individual amino acid is nonpolar, polar, or charged (AAs listed in abstract).
Regarding claim 20, Wei discloses establishing at least one translocation profile for the at least one modified individual amino acid as the at least one modified individual amino acid passes through the at least one nanopore biosensor (Figs. 2 and 3).
Response to Arguments
Applicant's arguments filed on filed on 23 March 2026 have been considered and are not fully persuasive and/or are moot in view of the new grounds of rejection.
Applicant's arguments do not specifically address the maintained grounds of rejection under 35 USC 112(a) and 35 USC 112(b).
The declaration filed on 23 March 2026 discusses the co-authors of a different reference that has been made of record and that has not been relied upon in rejections under 35 U.S.C. 102(a)(1). The declaration is insufficient to overcome the rejection of the claims based upon Wei ("N‑Terminal Derivatization-Assisted Identification of Individual Amino Acids Using a Biological Nanopore Sensor," ACS Sens. May 14, 2020) for the reasons set forth above in the "Response to Amendment" section.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE ADAMS whose telephone number is (571)270-5043. The examiner can normally be reached M, T, Th, and F, 12-4 P.M.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached on (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHELLE ADAMS/Examiner, Art Unit 1797
/JENNIFER WECKER/ Primary Examiner, Art Unit 1797
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