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/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
Group I. Claims 1-15, drawn to a nucleic acid, classified in C12Q1/6876.
Group II. Claims 16-17 and 19-20, drawn to a method of labeling a product, classified in C12Q2563/179.
Group III. Claim 26, drawn to a method of identifying a product or sample, classified in C12Q1/6818.
The inventions are independent or distinct, each from the other because:
The inventions of Group I and Groups II-III are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the L-DNA nucleic acid molecule of Group I could be used in a materially different process, such as hybridization-based enrichment.
The inventions of Group II and Group III are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have materially different designs. The process of Group II requires attaching an L-DNA segment having a unique identifier to a product, while the process of Group III does not. The process of Group III requires contacting a key molecule with a label molecule, while the process of Group II does not. Therefore, the processes of Groups II and III are materially different in design and mutually exclusive. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions have acquired a separate status in the art in view of their different classification
the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Steven Highlander on 11/7/2025 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-15. Affirmation of this election must be made by applicant in replying to this Office action. Claims 16-17,19-20, and 26 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Status
Claims 1-17, 19-20, and 26 are pending.
Claims 16-17, 19-20, and 16 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 telephone conversation with Steven Highlander on 11/7/2025.
Claims 1-15 are being examined on the merits.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement (see pg 9, ln 6-7). 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.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it is over 150 words and contains a typo. The first sentence reads “directed to the use of left-handed DNA (L-DNA) tracer to identify” and should read “directed to the use of left-handed DNA (L-DNA) tracers to identify”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 8 and 9 objected to because of the following informalities:
Claim 8 and claim 9 read “comprises or consists of an L-DNA segment, a D-DNA segment, or is a chimeric L-DNA/D-DNA segment” and should read “comprises or consists of an L-DNA segment, a D-DNA segment, or [[is]] a chimeric L-DNA/D-DNA segment”. This makes it clear that the chimeric L-DNA/D-DNA is an option for what the second or third region comprises or consists of, rather than being an entirely separate option.
Appropriate correction is required.
Claim Rejections - 35 USC § 112b - Indefiniteness
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 2, 4-5, 7-13, and 15 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 2 recites the limitation "said product" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claims 4-5, 8-13, and 15 depend from claim 2, inherit this deficiency, and are rejected on the same basis.
Claim 7 contains the phrase "such as", which renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Additionally, claim 7 contains a list of options for what the at least one piece of data or information comprises (“a date of manufacture…a location of manufacture…a manufacturer…a lot number…an expiration date”). However, there is no conjunction in this list (such as “and” or “or”). This renders the claim indefinite because it is unclear if the scope of the claim is that the piece of date or information comprises all of this information, or just one or more of these pieces of data/information. For purposes of examination these options are being interpreted as alternatives (or). Clarification is required.
Claim 11 recites the limitation "the first DNA spacer" in line 3. There is insufficient antecedent basis for this limitation in the claim. A first D-DNA spacer is defined in claim 10, but not in claim 2 or claim 1, from which claim 11 depends. Additionally, it is not defined whether this is L-DNA or D-DNA. Given that there are two main forms of DNA that the claims are directed to, it is imperative that the DNA type is defined to remove any ambiguity. For purposes of examination, the DNA spacers are interpreted to be D-DNA spacers, which is consistent with the phrasing in claim 10, however clarification is required.
Claim 12 recites the limitation "said second DNA spacers" in line 2. There is insufficient antecedent basis for this limitation in the claim. a second DNA spacer is defined in claim 11, but not in claim 10, claim 2, or claim 1, from which claim 11 depends. Additionally, it is not defined whether this is L-DNA or D-DNA. Given that there are two main forms of DNA that the claims are directed to, it is imperative that the DNA type is defined to remove any ambiguity. For purposes of examination, the DNA spacers are interpreted to be D-DNA spacers, which is consistent with the phrasing in claim 10, however clarification is required.
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 8-9, and 13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yazdi (Yazdi et al., US 2025/0092384 A1; EFD of 1/18/2022).
Yazdi teaches a method of labeling products with nucleic acid sequence tags for product validation (Abstract).
Regarding claim 1: Yazdi teaches a nucleic acid molecule having a randomized contiguous sequence that is a unique identifier for the nucleic acid molecule (paragraphs [0015, 0033]). Yazdi teaches that the nucleic acid can be L-DNA (paragraph [0059]).
Regarding claim 2: Yazdi teaches that the nucleic acid also comprises “characteristic positions” which encode information pertaining to a product that is being labeled (paragraph [0043, 0052]). The characteristic positions are non-random and contiguous (paragraph [0052, 0074, 0123]).
Regarding claim 3: Yazdi teaches that the random nucleic acid sequence (the first region) may be at least 10 nucleotides, at least 15 nucleotides, at least 20 nucleotides, at least 25 nucleotides or 10 to 30 nucleotides in length (paragraph [0035]).
Regarding claim 4: Yazdi teaches that the second region (the non-randomized sequence) is at least 5 nucleotides, at least 10 nucleotides, at least 15 nucleotides, at least 20 nucleotides or 10 to 30 nucleotides in length (paragraph [0074]).
Regarding claim 6: Yazdi teaches that the nucleic acid molecule is 100 nucleotides in length (paragraph [0054]).
Regarding claim 8: Yazdi teaches that the entirety of the nucleic acid molecule can comprise L-DNA, which would necessarily include the first and second regions (paragraph [0059]).
Regarding claims 5, 9, and 13: Claims 5, 9, and 13 further limit the optional third region of claim 2. Therefore, given that the third region is optional and Yazdi teaches the second region of claim 2, claims 5, 9, and 13 are also anticipated by Yazdi.
Claim Rejections - 35 USC § 103
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.
Claims 5, 7, 9, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Yazdi (Yazdi et al., US 2025/0092384 A1; EFD of 1/18/2022) as applied to claims 1-6, 8-9, and 13 above, and further in view of Yin (Yin et al., US 2021/0019973 A1; EFD 3/22/2018).
The teachings of Yazdi as they apply to claims 1-6, 8-9, and 13 are detailed above. Relevant to the instantly rejected claims, Yazdi teaches labeling products with nucleic acid molecules that comprise randomized/unique sequence domains and non-random sequence that encodes information associated with the product being labeled. Yazdi teaches that these nucleic acid molecules can be L-DNA.
Yazdi does not teach that the nucleic acid molecule comprises a third region comprising a capture moiety (claim 2b (optional), 9, and 13), that the information encoded by the second region is the lot number (claim 7), that the nucleic acid comprises a quenchable or activatable/inducible signaling agent (claim 14), or that the regions can occur in any order (claim 15). However, these features of a nucleic acid used in labeling a product are known in the art, as taught by Yin.
Yin teaches a method of labeling products with synthetic nucleic acid molecules (paragraph [0004]). Yin teaches that the nucleic acid “tags” (“barcodes”, “keys”, paragraph [0005]); reads on nucleic acid molecule) are used to uniquely identify products or product batches based on their unique oligonucleotide sequence (paragraph [0004]). Yin teaches that these tags can comprise multiple distinct domains (reads on regions; paragraph [0007]), and that the tags can include a sequence that is identified by a complement to the tag (paragraph [0127 and 0150]). Binding of a complementary sequence to the tag itself inherently means that the tag comprises a third region that consists of a capture moiety/capture sequence (claim 2b and claim 13).
It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the method of Yazdi with that of Yin to include a capture sequence in the molecule tag. One would be motivated to do so given the teaching of Yin that inclusion of a capture sequence allows identification/authentication of the tag with a complementary sequence (paragraph [0127]). One would have a reasonable expectation of success given that Yin additionally teaches the usage of L-DNA in product tags (paragraph [0160]), indicating to those skilled in the art that the complementarity authentication method as taught by Yin would be compatible with the L-DNA nucleic acid molecule as taught by Yazdi.
Regarding claim 5: Yin does not explicitly teach a range of nucleotide length for the third capture region. However, it is noted that the courts have found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Yin teaches that the overall length of the nucleic acid molecule is less than 50 nucleotides (paragraph [0145]). Determining the optimum length of capture sequence that is sufficient for hybridization to enable detection is achievable through routine experimentation by one skilled in the art.
Regarding claim 7: Yin teaches that the information associated with the product comprises a lot number (paragraph [0146 and 0148]).
Regarding claim 9: Yin teaches that all domains of the tag (unique sequences, capture sequences, etc.) can be L-DNA (paragraph [0160]).
Regarding claim 14: Yin teaches that the nucleic acid comprises fluorophore (quenchable agent; paragraph [0007, 0233-0234]).
Regarding claim 15: Yin teaches that the domains/regions can be in any order (paragraph [0162]).
Claims 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Yazdi (Yazdi et al., US 2025/0092384 A1; EFD of 1/18/2022) as applied to claims 1-6, 8-9, and 13 above, and further in view of Kim (Kim et al., Nucleic Acids Research 2007).
The teachings of Yazdi as they apply to claims 1-6, 8-9, and 13 are detailed above. Relevant to the instantly rejected claims, Yazdi teaches labeling products with nucleic acid molecules that comprise randomized/unique sequence domains and non-random sequence that encodes information associated with the product being labeled. Yazdi teaches that these nucleic acid molecules can be L-DNA.
Yazdi does not teach that the L-DNA domains are separated by D-DNA spacers (claim 10) which are substrates for nucleases (claim 12). However, L-DNA domains separated by D-DNA spacers are known in the art, as taught by Kim.
Kim teaches hairpin molecular beacons that are used for nucleic acid detection. Kim teaches the construction of a molecular beacon comprised of two L-DNA regions (the stem of the hairpin loop) separated by a D-DNA region (claim 10; the loop of the hairpin loop; Abstract and Table 2). Kim teaches that the D-DNA loop region is a substrate for nucleases (claim 12; Results - Biostablility of LS MBs).
It would have been prima facie obvious to one having ordinary skill in the art, before the effective filing date of the instant application, to have modified the method of Yazdi with that of Kim to space the first and second L-DNA regions with a D-DNA region. One would be motivated to do so given the teaching by Kim that employment of L-DNA regions with fluorophores and quenchers in a molecular beacon assay allows for detection of a target nucleic acid (Abstract), which could be utilized in the authentication of the molecular tag as taught by Yazdi (paragraph [0092]). Additionally, one would be motivated to employ this spacing structure given the assertion by Kim that L-DNA stems “prevents the probe from being opened by non-specific D-DNA sequences that contain short sequences complementary to the stem” (which eliminates false-positive signals) and “universally stabilize hairpin conformations of nucleic acid probes as long as D-type nucleic acids are used the loop” (Conclusion). One would have a reasonable expectation of success given that Kim successfully constructs a nucleic acid molecule with two L-DNA regions separated by a D-DNA spacer.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAILEY E CASH whose telephone number is (571)272-0971. The examiner can normally be reached Monday-Friday 8:30am-6pm ET.
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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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/KAILEY ELIZABETH CASH/Examiner, Art Unit 1683
/STEPHEN T KAPUSHOC/Primary Examiner, Art Unit 1683