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, Applicant hereby elects a combination of label molecules A and C for the species of molecule having a phosphor, label molecule B for the species of molecule having a microparticle, and the label molecule B microparticles are magnetic.in the reply filed on 10/27/2025is acknowledged.
Claims 8-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 10/27/2025.
Priority
The instant application claims was filed 03/29/2023 and claims foreign priority to JP2022-054622, filed 03/29/2022. The priority document is not in English.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/29/2023, 11/7/2023, 5/2/2024 are being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.831(c). Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or the like) must appear either in the drawings or in the Brief Description of the Drawings.
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete.
Required response - Applicant must:
• 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.
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 1-9 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.
Claim 1 is indefinite because it lacks a positive active step relating back to the preamble. The preamble recites a method for producing a complex, however the last positive active step is drawn to of isolating the complex. Therefore it is unclear as to whether the method is drawn to producing a complex or of isolating the complex.
Claim 1 recites, “forming the complex comprising the target, the label molecule A, the label molecule B, and the label molecule C;”…”wherein the target is a nucleic acid, the label molecule A comprises a nucleic acid sequence capable of hybridizing to a part of the target and substantially complementary to a nucleic acid sequence of the target, the label molecule B comprises the nucleic acid sequence capable of hybridizing to a part of the target and substantially complementary to the nucleic acid sequence of the target, a substantially complementary nucleic acid sequence of the label molecule A is capable of hybridizing to a part of the target and a substantially complementary nucleic acid sequence of the label molecule B is capable of hybridizing to another part of the target, the label molecule C comprises a nucleic acid sequence capable of hybridizing to a part of the label molecule A and substantially complementary to the nucleic acid sequence of the label molecule A, and at least one of either the label molecule A or the label molecule C has a phosphor.” The claim is confusing and unclear as it requires the label molecule A comprises a nucleic acid sequence capable of hybridizing to a part of the target and substantially complementary to a nucleic acid sequence of the target however label molecule B requires, “the label molecule B comprises the nucleic acid sequence capable of hybridizing to a part of the target and substantially complementary to the nucleic acid sequence of the target.” Thus it is unclear if label molecule B is substantially complementary to the nucleic acid sequence of the target or merely capable of hybridizing a portion of the target. If label molecule B is substantially complementary to the target, it is unclear where or how label molecule A or C hybridize to the target. There is similar issues with label molecule C with label molecule A.
Claim 1 recites, target molecule A,” “target molecule B,” and Target molecule C.” These appear to merely be names which provide no structural limitations, but provide what may be considered a functional limitation. However the functional limitations are relative to other nucleic acids. The claims provide no specific guidance on metes and bounds of how the different nucleic relates, where the portions start or stop, if they overlap, etc. This rejection may be addressed by providing a specific structure.
Claim 3 recites, “the label molecule D, the label molecule D has a nucleic acid sequence capable of hybridizing to a part of the label molecule B and substantially complementary to the nucleic acid sequence of the label molecule B.” The metes and bounds are unclear as the claim requires, “a nucleic acid sequence capable of hybridizing to a part of the label molecule B” and then later requires, “substantially complementary to the nucleic acid sequence of the label molecule B.” Thus it is unclear if the claim is drawn to a sequence capable of hybridizing to part of B or is substantially complementary to all of B.
Claim 3 recites, target molecule B,” “target molecule C,” and Target molecule D.” These appear to merely be names which provide no structural limitations, but provide what may be considered a functional limitation. However the functional limitations are relative to other nucleic acids. The claims provide no specific guidance on metes and bounds of how the different nucleic relates, where the portions start or stop, if they overlap, etc. This rejection may be addressed by providing a specific structure.
Claim 4 recites, “the z region is a nucleic acid sequence capable of hybridizing to a part of the target and substantially complementary to the nucleic acid sequence of the target.” The metes and bounds are unclear as the claim requires, “the z region is a nucleic acid sequence capable of hybridizing to a part of the target” and then later requires, “substantially complementary to the nucleic acid sequence of the target.” Thus it is unclear if the claim is drawn to a sequence capable of hybridizing to part of target or is substantially complementary to all of target.
Claim 4 recites, target molecule A,” “target molecule C,” “x region,” “y region,” “z region,” “X region,” “Y region,” “Z region.” These appear to merely be names which provide no structural limitations, but provide what may be considered a functional limitation. However the functional limitations are relative to other nucleic acids. The claims provide no specific guidance on metes and bounds of how the different nucleic (or regions) relates, where the portions start or stop, if they overlap, etc. This rejection may be addressed by providing a specific structure.
Claim 5 recites, target molecule A,” “target molecule C,” “x region,” “y region,” “z region,” “X region,” “Y region,” “Z region.” These appear to merely be names which provide no structural limitations, but provide what may be considered a functional limitation. However the functional limitations are relative to other nucleic acids. The claims provide no specific guidance on metes and bounds of how the different nucleic (or regions) relates, where the portions start or stop, if they overlap, etc. This rejection may be addressed by providing a specific structure.
Claim 6 recites, “the w region is a nucleic acid sequence capable of hybridizing to a part of the target and substantially complementary to the nucleic acid sequence of the target.” The metes and bounds are unclear as the claim requires, “the w region is a nucleic acid sequence capable of hybridizing to a part of the target” and then later requires, “substantially complementary to the nucleic acid sequence of the target.” Thus it is unclear if the claim is drawn to a sequence capable of hybridizing to part of target or is substantially complementary to all of target.
Claim 6 recites, “target molecule B,” “target molecule D,” “u region,” “v region,” “W region,” “U region,” “V region,” “W region.” These appear to merely be names which provide no structural limitations, but provide what may be considered a functional limitation. However the functional limitations are relative to other nucleic acids. The claims provide no specific guidance on metes and bounds of how the different nucleic (or regions) relates, where the portions start or stop, if they overlap, etc. This rejection may be addressed by providing a specific structure.
Claim 7 recites, “target molecule B,” “target molecule D,” “u region,” “v region,” “W region,” “U region,” “V region,” “W region.” These appear to merely be names which provide no structural limitations, but provide what may be considered a functional limitation. However the functional limitations are relative to other nucleic acids. The claims provide no specific guidance on metes and bounds of how the different nucleic (or regions) relates, where the portions start or stop, if they overlap, etc. This rejection may be addressed by providing a specific structure.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lou (US 20130023433), Urdea (5,681,697), Mao (Electrochemistry Communications 10 (2008) 1847–185)
Urdea teaches
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Lou teaches
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Thus Urdea and Lou teach appear to teach the structure of claims, but the art does not specifically teach the limitations of claim 1.
Therefore it would have been prima facie obvious to one of ordinary skill in the art the teachings of Urdea and Lou provide for target molecule A, target molecule B and target molecule C of the claims to allow for isolation. The artisan would be motivated to use these structures to allow for cooperative binding of the target molecules to allow isolation and detection by fluorophores attached to A or C. The artisan would have a reasonable expectation of success as the artisan is merely using known nucleic acid constructs.
With regards to claim 2, Urdea and Lou teach the use of solid supports.
Urdea and Lou do not specifically the use of magnetic beads.
However, Mao teaches the use of magnetic beads (figure 1).
Therefore it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claims to substitute the magnetic beads for the solid support of Lou and Urdea. The artisan would be motivated to use magnetic beads to allow for detection and/or isolation of use by magnets. The artisan would have a reasonable expectation of success as the artisan is merely modifying known nucleic acids with known magnetic beads.
With regards to claim 3, Urdea teaches LE1 (A), :LE2 (B), AMP1 (C) and AMP2 (D).
With regards to claim 4-7, these claims provide terms or names for additional target molecules or regions, which are indefinite for the reasons of record.. The teachings of Urdea and Lou can be interpreted to have regions encompassed by the names of the dependent claims in view of the lack of the specific structures. Thus the claims are prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claims the teaches of Lou, Urdea and Mao render these claims obvious.
Summary
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN C POHNERT PhD whose telephone number is (571)272-3803. The examiner can normally be reached Monday- Friday about 6:00 AM-5:00 PM, every second Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571)272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Steven Pohnert/Primary Examiner, Art Unit 1683
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