DETAILED ACTION
Status of the Claims
Claims 9-21, 24-26, and 28-31 are currently pending.
Claims 17-21 and 24 have been withdrawn as being drawn to non-elected subject matter (see below).
Claims 1-8, 20-21, and 27 are canceled by applicant.
Claims 9-16, 25-26, and 28-31 are examined herein.
The following Office Action is in response to Applicant’s communication dated 02/19/2026. Rejection(s) and/or objection(s) not reiterated from previous office actions are hereby withdrawn. The following rejection(s) and/or objection(s) are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Restriction Requirement
Applicant's election with traverse of Invention II in the reply filed on 11/10/2025 is acknowledged. The traversal is on the ground(s) that Inventions II and III overlap in scope and are intended to be used together. This is not found persuasive because the two inventions are related as apparatus and product made. The inventions in this relationship are distinct if either or both of the following can be shown: (1) that the apparatus as claimed is not an obvious apparatus for making the product and the apparatus can be used for making a materially different product or (2) that the product as claimed can be made by another and materially different apparatus (MPEP § 806.05(g)). In this case the product can be made by a materially different apparatus such as manually with a series of pipettes.
Claims 17-21 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/10/2025.
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Response to Arguments
The 02/19/2026 remarks argue: Inventions should be rejoined.
Applicant's arguments have been fully considered but they are not persuasive for at least the following reasons.
Note that the restriction requirement has been updated as above. Further, it is noted that upon indication of allowable subject matter for elected Invention II, any withdrawn claims comprising all the limitations of allowed claims will be considered for rejoinder and allowance.
New Claim Objections
Necessitated by Amendment
Claim 29-31 is objected to as being dependent upon a rejected base claim, but would be free from the prior art if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Appropriate correction is required.
Maintained Claim Rejections – 35 U.S.C. 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 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)(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.
Wei et al.
Claims 9, 11-16, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wei et al. (Production of dumbbell probe through hairpin cleavage-ligation and increasing RCA sensitivity and specificity by circle to circle amplification. Sci Rep 6, 29229 (2016). https://doi.org/10.1038/srep29229, of record).
Regarding claim 9, Wei discloses a plurality of oligonucleotides, comprising a plurality of different oligonucleotide hairpins each comprising a loop region, a stem region, and an overhang region (e.g., the oligonucleotide hairpins resulting from ligating constructs previously cleaved with EcoRI, PstI, or NsiI, and/or listed in Table S1) and comprising a plurality of different “invading” single-stranded oligonucleotides (e.g., the RCA primers as per Fig. 3 and/or in Table S1). Regarding the functional language of payload regions encoding for arbitrary information, it is noted that nucleic acid regions or sequences can inherently encode for information, as per the claim, by virtue of their identities and/or order of nucleotide(s). See MPEP § 2114.
Regarding claim 11, the loops of hairpins taught by Wei comprise at least one nucleotide (e.g., as per the Formation of circular DP by cleavage-ligation of hairpin section on p. 2 and/or Table S1).
Regarding claim 12, Wei discloses that the loop regions comprise one or more nucleotides (e.g., as per the Formation of circular DP by cleavage-ligation of hairpin section on p. 2 and/or Table S1) and therefore the identities of these nucleotide(s) can reasonably represent one or more bits.
Regarding claim 13, Wei discloses the above, wherein the overhangs are at least 3 nucleotides (e.g., as per the Formation of circular DP by cleavage-ligation of hairpin section on p. 2 and/or Table S1).
Regarding claim 14, Wei discloses the above, wherein the stem regions are at least 5 base pairs (e.g., as per the Formation of circular DP by cleavage-ligation of hairpin section on p. 2 and/or Table S1).
Regarding claim 15, Wei discloses the above, wherein the first oligonucleotide hairpin and the second oligonucleotide hairpin have nucleotide sequences such that an end nucleotide on a non-overhang side of the first stem region of the first oligonucleotide is directly adjacent to an end nucleotide on the second overhang region of the second oligonucleotide hairpin when the first overhang region of the first oligonucleotide hairpin is hybridized to the second overhang region of the second oligonucleotide hairpin (e.g., as per Fig. 1A).
Regarding claim 16, Wei discloses the above, wherein the first loop region includes at least one nucleotide that is not part of the first payload region (e.g., since the loops regions are several nucleotides in length and the “payload region” is an arbitrary portion thereof).
Regarding claim 26, Wei discloses the above, wherein each invading strand has a sequence configured to open the corresponding oligonucleotide hairpin through branch migration (e.g., via the strand displacement activity of Phi29 polymerase as per the Methods section on p. 8).
Regarding claim 27, Wei discloses the above, wherein each invading strand has a sequence configured to hybridize the corresponding oligonucleotide hairpin without hybridizing to other oligonucleotide hairpins (e.g., as a means to increase specificity, as per Fig. 6).
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Response to Arguments
The 02/19/2026 remarks argue: not all elements are taught.
Applicant's arguments have been fully considered but they are not persuasive for at least the following reasons.
RE: “the first payload region and the second payload region must be interpreted as different sequences” (page 18) and “if the ‘first payload region’ and the ‘second payload region’ of independent claim 9 both encoded the same arbitrary information, this would be clearly inconsistent with the specification's teachings because all hairpins would include the same payloads and a user of the invention will be limited to creating a string of only 0's or only 1's; it would be impossible to ‘encode[] a specific string of arbitrary information in the assembled oligonucleotide.’ Specification, paragraph [0008]. Interpreting the first and second payload regions as potentially having the same sequence is clearly inconsistent with interpretation that those skilled in the art would reach and inconsistent with the specification” (page 19).
Here, Applicant asserts that the first payload region and the second payload region must be interpreted as different sequences and that to do so otherwise would limit the invention to only being able to generate strings of only 1’s or only 0’s. However, this is not consistent with the specification. For example, para [0032] states (in part):
The payload region 118A is at least one nucleotide long but may be much longer. The length of the payload region 118A depends upon the arbitrary information and the encoding scheme. For example, the nucleotide base G or C may be used to encode the binary digit 0 while the nucleotide base A or T may be used to encode the binary digit 1. A length of the payload region 118A can be 1-5 nucleotides.
The disclosure makes it clear that the payload region can be as short as one nucleotide and may encode for one of two possible values, namely, 0 or 1 (in one embodiment). If Applicant’s interpretation were correct and the first and second payload regions must be different, then one would only be able to encode a series such as 01010101…
Rather, the examiner’s interpretation (which is consistent with the specification) is that the first payload region can be the same or different from the second payload region. In this light, the claims are properly anticipated by the Wei reference, as detailed above.
Maintained Claim Rejections – 35 U.S.C. 103(a)
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Wei et al.
Claims 9-16, 25-26, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Wei et al. (Production of dumbbell probe through hairpin cleavage-ligation and increasing RCA sensitivity and specificity by circle to circle amplification. Sci Rep 6, 29229 (2016). https://doi.org/10.1038/srep29229, of record).
Wei is relied on as above for claims 9, 11-16, and 26.
Regarding claim 10, Wei does not explicitly disclose that the plurality of oligonucleotides is present in different containers. However, it is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). In the instant case, it is noted that oligonucleotides of different sequences are generally synthesized separately (e.g., using phosphoramidite chemistry), and therefore there is reason to believe that they at one point would reside in different containers.
Regarding claims 25 and 28, Wei is silent on the limitations that each oligonucleotide hairpin has a total length of 18-25 nucleotides and are present in the different containers at concentrations that are independently 0.5-50 nM. However, in general, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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. Further, Wei discusses the lengths of the oligonucleotides used to form hairpins are result-effective variables and are subject to optimization (e.g., as per the Formation of circular DP by cleavage-ligation of hairpin section on p. 2).
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Response to Arguments
Applicant does not offer further arguments regarding the above obviousness rejections beyond what was set forth with regard to the 35 U.S.C. § 102 rejection, above. To the extent that Applicant is merely repeating their previous argument, the Examiner contends that those issues were adequately addressed in the above sections, which are incorporated in their entireties herein by reference.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEREMY FLINDERS whose telephone number is (571)270-1022. The examiner can normally be reached M-F 10-6:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached on (571)272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEREMY C FLINDERS/Primary Examiner, Art Unit 1684
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