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 .
Claims 79-95 are pending. Claims 90-95 are being examined on the merits. Claims 79-89 are withdrawn.
Election/Restrictions
Applicant’s election of Group II (claims 90-95) in the reply filed on June 3, 2026 is acknowledged. 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)).
Claims 79-89 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 3, 2026.
Information Disclosure Statement
The Information Disclosure Statements submitted August 4, 2023 and June 3, 2026 have each been considered.
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 – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings. Specifically, nucleotide sequences appear in Fig. 3F, but are not identified by sequence identifiers.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, 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.
Specification
The disclosure is objected to because of the following informalities: the “Related Applications” paragraph on p. 1 should be updated to indicate that US Serial No. 15/542,953 has issued into US Patent No. 11,639,522.
Appropriate correction is required.
Claim Objections
Claim 90 is objected to because of the following informalities:
In claim 90, the limitation “the first … and the second nucleic acid probe each comprises
…” in l. 1 of step (a) should be “the first … and the second nucleic acid probe each comprise …”. Similarly, the limitation “the first primers each comprises …” in l. 1 of step (iii) should be “the first primers each comprise …”.
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 90-95 are is 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.
Claim 90 recites, in part, “the first … and the second nucleic acid probe each comprise[]
… a double-stranded … (UMI) region comprising a UMI sequence” and “the first primers each comprise[] a single-stranded UMI region comprising a UMI sequence”, the meaning of which is unclear. First, it is unclear how many different UMI sequences are present in the claim. That is, the claim recites “a [single] UMI sequence”, however it is not clear if that is intended to mean that all of the UMI sequences are the same. It is additionally unclear what component(s) of the composition is/are intended to be capable of being uniquely identified. For example, is each of the first and second nucleic acid probes and the first primers intended to be distinguishable one from another, in which case it seems that at least 3 different UMIs would be required, or is the protein target intended to be uniquely identified, in which case it seems that only 1 UMI would be required? Finally, it is unclear if the UMI is double-stranded or single-stranded as both options seem to be contemplated in the claim. Since the ordinary artisan would not be able to determine the metes and bounds of the claim, it is indefinite.
Claims 91-95 depend from claim 90 and thus incorporate the indefiniteness issues of claim 90.
Claim 94 contains the trademark/trade name “DeepVentR”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the source of an enzyme and, accordingly, the identification/description is indefinite.
Prior Art
Claims 90-95 are free of the art. The closest art is Soederberg1 (US Patent App. Pub. No. 2017/0009278 A1; effective filing date 2014), Jones2 (WO 2014/144371) and Chee3 (US 9,879,313; effective filing date 2013).
Soederberg is directed to methods and compositions for detecting an analyte in a
sample using proximity probes comprising an analyte-binding domain and a nucleic acid domain. Specifically, Soederberg teaches that the proximity probes comprise antibodies, with specific binding affinity for a protein target, where the antibody is coupled to a nucleic acid probe. Soederberg also teaches oligonucleotides in addition to the nucleic acid domains for use in a hybridization chain reaction assay, which does not require the use of an enzyme (e.g., Fig. 1; paras. 4, 11-13, 160; claims 27-34).
Jones is directed to methods and compositions for the simultaneous detection of target
protein and target nucleic acids in a single cell comprising methods and reagents for detection and analysis of nucleic acids. The methods employ proximity extension assays for detection of a target nucleic acid of interest. The methods can additionally be used in multiplex assays with a protein proximity extension assay to detect protein. Jones uses a pair of oligonucleotides for proximity probes, and teaches that one of the proximity probes can comprise a blocking group at the 3’ end (Abstract; paras. 8; Figs. 1-2; claims 1 and 10).
Chee is directed to methods and assay systems for use in spatially encoded biological assays, including assays to determine a spatial pattern of abundance, expression and/or activity of one or more biological targets, including proteins, across multiple sites in a sample. Chee additionally teaches methods and assay systems capable of high levels of multiplexing where reagents are provided to a biological sample in order to address tag the sites to which reagents are delivered, instrumentation capable of controlled delivery of reagents, and a decoding scheme providing a readout that is digital in nature. Chee further teaches that nucleic acid probes with various nucleic acid binding sites and barcodes, and teaches that the address tags can be uniquely identified (Abstract; Figs. 3-6; Example 5; col. 28, ll. 26-67; col. 29, ll. 1-43).
However, Soederberg, Jones and Chee, whether considered alone or in combination, do not teach the combination of molecules recited in claim 90, nor do they teach the particular structures of the first and second nucleic acid probes and the first and second primers. Further, while many of the individual component features are known in the art, as noted, there does not appear to be any motivation to modify the compositions of any of Soederberg, Jones and Chee to arrive at the particular combination of molecules and component feature arrangements recited in claim 90.
Conclusion
Claims 90-95 are being examined and are rejected. Claim 90 is objected to. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN GREENE whose telephone number is (571)272-3240. The examiner can normally be reached M-Th 7:30-5:30 EST.
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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.
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/CAROLYN L GREENE/Primary Examiner, Art Unit 1681
1 Soederberg was cited in the Information Disclosure Statement submitted June 3, 2026.
2 Jones was cited in the Information Disclosure Statement submitted August 4, 2023.
3 Chee was cited in the Information Disclosure Statement submitted August 4, 2023.
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