DETAILED CORRESPONDENCE
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-8 are pending in the application and are being examined on the merits.
Priority
This application is filed under 35 U.S.C. 120 as a continuation application of U.S. non-provisional application no. 17/115,223, filed December 8, 2020, which issued as U.S. Patent No. 12,134,634, which claims domestic priority under 35 U.S.C. 119(e) to U.S. provisional application no. 62/947,155, filed December 12, 2019.
Applicant states that this application is a continuation application of the prior-filed application. A continuation application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the following matter not disclosed in the prior-filed application: “quantifying a Near Infra-Red (NIR) tissue transparency window fluorescence” in claim 1 and “other light source excitation” in claim 6. Claims 1-8 have an effective filing date of September 24, 2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 24, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner.
Specification/Informalities
The specification is objected to because the sequence incorporation statement lists the size of the XML file in kilobytes. The size of the XML file should be listed in bytes (not kilobytes). See MPEP 2413.04. Appropriate correction is required.
The listing of references in the specification at pp. 67-71 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.
Drawing Figures
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2), yet fails to comply with the requirements of 37 CFR 1.821 through 1.825; applicants’ attention is directed to the final rulemaking notice published at 55 FR 18230 (May 1, 1990), and 1114 OG 29 (May 15, 1990). See particularly drawing figure 1(a).
To be in compliance, applicants should identify nucleotide sequences of at least 10 nucleotides and amino acid sequences of at least 4 amino acids in the specification by a proper sequence identifier, i.e., “SEQ ID NO:” (see MPEP 2422.01). If these sequences have not been listed in the computer readable form and paper copy of the sequence listing, applicant must provide an initial computer readable form (CRF) copy of the “Sequence Listing”, an initial paper copy of the “Sequence Listing”, as well as an amendment directing its entry into the specification, and a statement that the content of the paper and CRF copies are the same and, where applicable, include no new matter as required by 37 C.F.R. 1.821(e) or 1.821(f) or 1.821(g) or 1.821(b) or 1.825(d).
Claim Objections
Claim 8 is objected to in the recitation of “biological tissue within living animal” and in the interest of improving claim form, it is suggested that the noted phrase be amended to recite (with markings to show changes made) “biological tissue within a living animal.”
Claim Rejections - 35 USC § 112(b)
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 1-8 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 (claims 2-8 dependent therefrom) recites “miRFP718nano protein, with a sequence of at least 95% identity to SEQ ID NO: 4,” which is inconsistent with the disclosure of the specification describing “miRFP718nano protein” as SEQ ID NO: 4 (e.g., specification at p. 73) and not as a protein with a sequence of at least 95% identity to SEQ ID NO: 4. It is suggested that applicant clarify the meaning of “miRFP718nano protein.”
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 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Verkhusha et al. (U.S. 2021/0179675 A1; cited on the attached Form PTO-892; hereafter “Verkhusha”). As stated above, claims 1-8 have an effective filing date of September 24, 2024.
The claims are drawn to a method for optical imaging a biological sample comprising exposing a biological sample containing therein an isolated fluorescent miRFP718nano protein, with a sequence of at least 95% identity to SEQ ID NO: 4, to an fluorescence excitation wavelength and quantifying a Near Infra-Red (NIR) tissue transparency window fluorescence therefrom so as to image the biological sample.
Regarding instant claim 1, Verkhusha teaches a bright near infra-red fluorescent protein miRFP718nano (paragraph [0011]), which has the amino acid sequence of SEQ ID NO: 4 (paragraph [0018]). SEQ ID NO: 4 of Verkhusha is identical to instant SEQ ID NO: 4. Verkhusha teaches a method of optical imaging, the method comprising the step of expressing in a cell a nucleic acid sequence encoding one of the proteins as described herein and detecting or quantifying fluorescence therefrom (paragraph [0030]). Verkusha teaches the excitation/emission wavelengths for miRFP718nano are 690 nm/718 nm (paragraph [0193]; Table 1), which are within a NIR tissue transparency window of 650-900 nm (paragraph [0052]).
Regarding instant claims 2 and 8, Verkhusha teaches the expression system may be used in prokaryotic or eukaryotic hosts (paragraph [0112]).
Regarding instant claims 3, 4, and 8, Verkhusha teaches the fluorescent proteins find use as a biomolecule labels, or cell organelle labels in living and fixed cells (paragraph [0147]).
Regarding instant claims 5 and 8, Verkhusha teaches expressing the nucleic acid in a mammalian expression system (paragraph [0110]).
Regarding instant claims 6 and 8, Verkhusha teaches imaging live cells using a laser for excitation (paragraph [0228] and a halide arc lamp (paragraph [0231].
Regarding instant claim 7, Verkhusha teaches using the miRFPnano for deep-tissue imaging (paragraph [0212]).
Therefore, Verkhusha anticipates claims 1-8 as written.
Citation of Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Oliinyk et al. (Nature Methods 20:70-74, January 2023; cited on the attached Form PTO-892) discloses miRFP718nano and its use for deep-tissue imaging (see whole document).
Conclusion
Status of the claims:
Claims 1-8 are pending.
Claims 1-8 are rejected.
No claim is in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID J STEADMAN whose telephone number is (571)272-0942. The examiner can normally be reached Monday to Friday, 7:30 AM to 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MANJUNATH N. RAO can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/David Steadman/Primary Examiner, Art Unit 1656
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