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 without traverse of Group I and species in the reply filed on 12/08/2025 is acknowledged.
No prior art was found for the compound of formula 1 with Z1 is NR5R6 or OR7, wherein at least one of R1 to R11 is a moiety substituted with phosphoramidite or active ester.
The examination has been extended to Formula 2, wherein Ar1=unsubstituted C6 aryl, Z2=O, Y=CR9R10, with R9=unsubstituted C1 alkyl, R10=C5 alkyl substituted with an active ester, and R1- R2=hydrogen.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
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.
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 it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
The instant specification discloses nucleic acid sequences in pages 45-48.
For compliance with sequence rules, it is necessary to include the sequence in the "Sequence Listing" and identify them with SEQ ID NOS for both nucleic acid sequences and amino acids sequences of more than three amino acids. In general, any nucleotide sequence that is disclosed that otherwise meets the criteria of CFR 1.821(a), must be set forth in the "Sequence Listing" (See MPEP 2422.03 for further guidance).
While the Examiner has made every attempt to check the instant specification for sequence compliance, Applicant is required to carefully check the entire specification for any and all issues regarding sequence compliance.
Specification
The disclosure is objected to because of the following informalities: The structures in the Preparation Example 1. Synthesis of compound 1 (page 42), and Preparation Example 2. Synthesis of compound 2 (page 44) are not clear.
Appropriate correction is required.
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.
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.
Claims 1-10 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.
In claims 1, 9-10 the term “substituted” is recited throughout and is vague and indefinite because it is unclear of exactly what type of substituent moieties are used.
Note that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. Also see In re Van Geuns, 988 F.2d 1181,26 USPQ2d 1057 (Fed. Cir. 1993). Also see, In reZletz, 13 USPQ2d 1320,1322. “An essential purpose of patent examination is to fashion claims that are precise, clear, correct and unambiguous.”
Claim Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for reporter of Formula 1 and 2 as shown in Examples 1-2 , does not reasonably provide enablement for a reporter comprising a broad structure of formula 1 and 2 because of the high numbers of substituents for Ar1, Z1, Z2, Y, X, R1-R11. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The instant claims encompass a reporter for labeling a nucleic acid represented by Formula 1 or 2, covering a very wide range of compounds because of the parameters Ar1, Z1, Z2, Y, X, R1-R11.
The invention is a reporter represented by Formula 1 or 2 that are useful for labeling a nucleic acid for PCR applications.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure: Since there are only 2 examples, and no written description of the groups included in the generic definition of Ar1, Z1, Z2, Y, X, R1-R11, the amount of experimentation is very high and burdensome. Therefore, it is not seen where the instant specification enables the ordinary artisan to make and/or use the instantly claimed invention.
MPEP 2164.01 (a) states, "A conclusion of lack of enablement means that based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed.Cir. 1993)." That conclusion is clearly justified here. Thus, undue experimentation will be required to practice Applicants' invention.
Claims 1-10 are rejected under 35 U.S.C. 112, first paragraph, 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(s), at the time the application was filed, had possession of the claimed invention.
To satisfy the Written description requirement, applicant must convey with reasonable clarity to one skilled in the art, as of the filing date that applicants were in possession of the claimed invention. Applicant’s claims are drawn to a reporter for labeling a nucleic acid represented by Formula 1 or 2, covering a very wide range of compounds because of the parameters Ar1, Z1, Z2, Y, X, R1-R11. The invention is a reporter represented by Formula 1 or 2 that are useful for labeling a nucleic acid for PCR applications.
The expression of generic groups /moieties substituted or non-substituted aryl or heteoroaryl, substituted or non-substituted alkyl, alkenyl, alkynyl, groups, acylamino, acyloxy, phosphino, carboxyl, sulfonyl, ester, ketone, halogens, germanium, boron, aluminum, and so on, for the parameters Ar1, Z1, Z2, Y, X, R1-R11 for example, does not convey to one of ordinary skill in the art that applicants were in possession of the claimed subject matter. The functional language recited without any correlation does not meet the written description requirement, as one of ordinary skill in the art could not recognize or understand which groups/moieties are included by the mere recitation of the generic term. Claims employing generic term language at the point of novelty, such as applicants’, neither provide those elements required to practice the inventions, nor “inform the public” during the life of the patent of the limits of the monopoly asserted. The expression could encompass myriads of groups/ moieties and applicants claimed expression represents only an invitation to experiment regarding possible combinations and compounds.
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.
Claim(s) 1, 5-7, 9-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Song et al. EP 3309552A1.
Song et al. discloses a compound of Formula 2, wherein Ar1=unsubstituted C6 aryl, Z2=O, Y=CR9R10, with R9=unsubstituted C1 alkyl, R10=C5 alkyl substituted with active ester (N-hydroxy succinimide derivative), and R1- R2=hydrogen (see page 65 compound 46). Song et al. discloses the compound of Formula 3 of claim 7, wherein x=5 and E=active ester; and the compound of Formula 6 of claim 10, wherein Z2=O, X=O, Y=CR9R10, with R9=unsubstituted C1 alkyl, R10=C5 alkyl substituted with active ester, and R1-R4 and R12- R15=hydrogen.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEZIA RILEY whose telephone number is (571)272-0786. The examiner can normally be reached 7:30-6:00pm.
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, Gary Benzion can be reached at 571-272-0782. 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.
/JEZIA RILEY/Primary Examiner, Art Unit 1681 21 January 2026