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 .
Please note: The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election/Restriction
Applicant’s election of Group I (claims 1-15) in the telephone call with Steven Highlander on 11/7/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement in their response filed on 4/16/2026, the election has been treated as an election without traverse and is made FINAL (MPEP § 818.01(a)).
Claim Status
Claims 1-9, 11-17, 19-20, and 26 are pending.
Claims 16-17, 19-20, and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1-9 and 11-15 are being examined on the merits.
Response to Amendment
The amendment to the claims filed on 4/16/2026 does not comply with the requirements of 37 CFR 1.121(c) because the subject matter added to claim 8 (the word “comprises”) was not properly indicated with underlining of the added text. Amendments to the claims filed on or after July 30, 2003 must comply with 37 CFR 1.121(c) which states:
(c) Claims. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
(1) Claim listing. All of the claims presented in a claim listing shall be presented in ascending numerical order. Consecutive claims having the same status of “canceled” or “not entered” may be aggregated into one statement (e.g., Claims 1–5 (canceled)). The claim listing shall commence on a separate sheet of the amendment document and the sheet(s) that contain the text of any part of the claims shall not contain any other part of the amendment.
(2) When claim text with markings is required. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. Only claims having the status of “currently amended,” or “withdrawn” if also being amended, shall include markings. If a withdrawn claim is currently amended, its status in the claim listing may be identified as “withdrawn—currently amended.”
(3) When claim text in clean version is required. The text of all pending claims not being currently amended shall be presented in the claim listing in clean version, i.e., without any markings in the presentation of text. The presentation of a clean version of any claim having the status of “original,” “withdrawn” or “previously presented” will constitute an assertion that it has not been changed relative to the immediate prior version, except to omit markings that may have been present in the immediate prior version of the claims of the status of “withdrawn” or “previously presented.” Any claim added by amendment must be indicated with the status of “new” and presented in clean version, i.e., without any underlining.
(4) When claim text shall not be presented; canceling a claim.
(i) No claim text shall be presented for any claim in the claim listing with the status of “canceled” or “not entered.”
(ii) Cancellation of a claim shall be effected by an instruction to cancel a particular claim number. Identifying the status of a claim in the claim listing as “canceled” will constitute an instruction to cancel the claim.
(5) Reinstatement of previously canceled claim. A claim which was previously canceled may be reinstated only by adding the claim as a “new” claim with a new claim number.
As noted above, the amendment under consideration herein fails to comply with 37 CFR 1.121 because the claim listing does not contain the appropriate markings indicating matter added to the amended claims. Thus, the amendment could be considered non-responsive. However, in the interest of compact prosecution the amendment at issue will not be considered non-responsive. However, any future responses failing to comply with 37 CFR 1.121 will be held non-responsive, and will not be considered.
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.
No IDS was provided in the reply filed on 4/16/2026. Therefore, any references in the specification not cited by the Examiner on form PTO-892 remain unconsidered.
Drawings
Applicant’s submission of new Drawings on 4/16/2026 in black and white is acknowledged and the new Drawings are accepted.
Abstract
Applicant’s amendment to the Abstract (submitted on 4/16/2026) to be under 150 words in length is acknowledged.
The abstract of the disclosure is objected to because it 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).
Response to Remarks
The objection to the Abstract is maintained given that the substitute Abstract filed on 4/16/2026 did not correct the above-mentioned typo.
Claim Objections
Withdrawn:
The objection to claims 8 and 9 as detailed in the Office Action of 11/18/2025 are withdrawn in light of Applicant’s amendments to the claims.
New (Necessitated by Amendments):
Claims 1, 9, and 15 are objected to because of the following informalities:
Claim 1 reads “a second region that is a non-randomized contiguous L-DNA segment is correlated with” and should read “a second region that is a non-randomized contiguous L-DNA segment that is correlated with”.
Claim 9 reads “said third region comprises or consists of an L-DNA segment, a D-DNA segment, or is comprises chimeric L-DNA/D-DNA segment” and should read “said third region comprises or consists of an L-DNA segment, a D-DNA segment, or [[is]] comprises a chimeric L-DNA/D-DNA segment”.
Claim 15 reads “wherein said first, second and optionally third sequence can occur in any order” and should read “wherein said first, second and optionally third [[sequence]]region can occur in any order” to maintain consistent claim terminology.
Appropriate correction is required.
Claim Rejections - 35 USC § 112b - Indefiniteness
Withdrawn:
The rejection of claims 2, 4-5, 7-13, and 15 under 35 U.S.C. 112(b) as detailed in the Office Action of 11/18/2025 are withdrawn in light of Applicant’s amendments to the claims and cancellation of claim 10.
New (Necessitated by Amendments):
Claims 8 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 8: The scope of claim 8 encompasses the limitation wherein the second region comprises or consists of a D-DNA segment or comprises a chimeric L-DNA/D-DNA segment. Claim 8 depends from claim 2 and ultimately claim 1. In claim 1, a second region is defined as “a non-randomized contiguous L-DNA segment”. It is unclear how the second region, which is an L-DNA segment, can comprise or consist of a D-DNA segment or comprise a chimeric L-DNA/D-DNA segment. This would be inconsistent with the claim limitations of claim 1, and therefore makes scope of claim 8 unclear. Clarification is required.
Claim 15: The scope of claim 15 indicates that the third sequence (region) is optionally included as being able to occur in any order. However, claim 15 depends from claim 2, which requires that the nucleic acid molecule comprises a third region. It is unclear how the third region being optionally included as being in any order in the nucleic acid molecule affects the structure of said nucleic acid molecule. It is also unclear if this is in direct contradiction to the limitations of claim 2. Is it optional that the third sequence is present in the nucleic acid or is it optional that it occur in any order? Clarification is required.
Claim Rejections - 35 USC § 112d
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 8 and 15 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 8: The scope of claim 8 encompasses the limitation wherein the second region comprises or consists of a D-DNA segment or comprises a chimeric L-DNA/D-DNA segment. However, this does not include all the limitation of the claim upon which it depends. Claim 8 depends from claim 2 and ultimately claim 1. In claim 1, a second region is defined as “a non-randomized contiguous L-DNA segment”. Therefore, the second region is an L-DNA segment and cannot comprise or consist of a D-DNA segment or comprise a chimeric L-DNA/D-DNA segment. Claim 8 is inconsistent with the claim limitations of claim 1 and fails to include all the limitations of the claim upon which it depends.
Claim 15: The scope of claim 15 indicates that the third sequence (region) is optional. However, claim 15 depends from claim 2, which requires that the nucleic acid molecule comprises a third region. Therefore, claim 15 fails to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Withdrawn Claim Rejections - 35 USC § 102 and 103
The rejection of claims 1-6, 8-9, and 13 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) is withdrawn in light of Applicant’s amendments to the claims.
The rejection of claims 5, 7, 9, and 13-15 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) is withdrawn in light of Applicant’s amendments to the claims.
The rejection of claims 10 and 12 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) is withdrawn in light of Applicant’s amendments to the claims and cancellation of claim 10.
New Claim Rejections - 35 USC § 103
Necessitated by Amendments
Claims 1, 3, 6, and 14 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; cited on PTO-892 of 11/18/2025) in view of Kim (Kim et al., Nucleic Acids Research 2007; ; cited on PTO-892 of 11/18/2025).
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 (reads on a first region; paragraphs [0015, 0033]). 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]). The characteristic positions that encode information read on a second region. Yazdi teaches that the nucleic acid can be L-DNA (paragraph [0059]).
Yazdi does not teach that the first and second L-DNA regions are separated by a first D-DNA spacer. 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 (the loop of the hairpin loop; Abstract and Table 2).
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 in 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.
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 6: Yazdi teaches that the nucleic acid molecule is 100 nucleotides in length (paragraph [0054]).
Regarding claim 14: Kim teaches the nucleic acid molecule comprises a quenchable agent (a fluorophore; Figure 1 and Introduction).
Claims 2, 4-5, 7-9, 13, and 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; cited on PTO-892 of 11/18/2025) in view of Kim (Kim et al., Nucleic Acids Research 2007; cited on PTO-892 of 11/18/2025) as applied to claims 1, 3, 6, and 14 above, and further in view of Yin (Yin et al., US 2021/0019973 A1; EFD 3/22/2018; cited on PTO-892 of 11/18/2025).
The teachings of Yazdi in view of Kim as they apply to claims 1, 3, 6, and 14 are detailed above. Relevant to the instantly rejected claims, Yazdi in view of Kim teach 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 in view of Kim teach that these nucleic acid molecules comprise L-DNA segments separated by D-DNA spacers.
Yazdi in view of Kim do not teach that the nucleic acid molecule comprises a third region comprising a capture moiety (claims 2, 9, and 13), that the information encoded by the second region is the lot number (claim 7), 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.
Regarding claims 2 and 13: 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 2 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 in view of Kim 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 in view of Kim.
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 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 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 claim 9: Yin teaches that all domains of the tag (unique sequences, capture sequences, etc.) can be L-DNA (paragraph [0160]).
Regarding claim 15: Yin teaches that the domains/regions can be in any order (paragraph [0162]).
Response to Remarks
Applicant's arguments filed 4/16/2026 (pages 8-9 of Remarks) have been fully considered but they are not persuasive. The arguments pertain to the anticipation of claim 1 by Yazdi. This rejection has been withdrawn in light of Applicant’s amendments to claim 1.
Applicant argues on page 8 of Remarks that “the mere mention of L-DNA cannot provide a sufficient teaching to place the claimed methods in the public domain”. However, Yazdi teaches a molecule which can contain L-DNA segments and further teaches, within the paragraph provided by Applicant, why those of skill in the art would choose to use L-DNA. Yazdi teaches that L-DNA has “improved resistance to biodegradation” which is advantageous in the case of using nucleic acid sequence tags which are exposed to the environment. Applicant next argues that the disclosure provides “absolutely no information on how one would actually employ an L-DNA sequence in a useful method” or “how one could interrogate a sample that putatively contains such a molecule”. The use of L-DNA, and L-DNA/D-DNA chimeric molecules is well-known in the art, as exemplified by one of the references used above, Kim. Kim teaches construction of a molecular beacon in which two segments of L-DNA are separated by a D-DNA spacer. Kim teaches that this molecule can generate a signal output when hybridized with complementary L-DNA oligonucleotides which cause separation of a fluorophore and quencher and thus exemplifies how such a molecule could be used.
Applicant states that the subject matter of previous claim 10 (now canceled) was not rejected. However, in the previous Office Action of 11/18/2025 claim 10 was rejected over Yazdi in view of Kim. Newly amended claim 1, which contains the limitation of claim 10 of a D-DNA spacer, is newly rejected under 35 USC 103 as being unpatentable over Yazdi in view of Kim.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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