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 .
Status of the Application
The Response and Amendment filed December 23, 2025 is acknowledged.
Claims 1-14 were pending. Claims 1-9 and 12-14 are being examined on the merits. Claims 10-11 are canceled.
Response to Arguments
Applicant’s arguments filed December 23, 2025 have been fully considered.
The following objections and rejections are WITHDRAWN in view of Applicant’s arguments and amendments to the claims and specification:
Objections to claims 1-2, 4-5, 7 and 12
Rejection of claims 1-14 under 35 USC § 112(b), indefiniteness
Rejection of claims 10-11 under 35 USC § 112(d)
The following objections are MAINTAINED:
Objections to the Specification
Response to arguments regarding Objections to the Specification
Applicant has amended the specification to address the objections related to the use of tradenames or marks in the specification. However, Applicant overlooked two instances, as follows:
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The objection is maintained as to those two instances.
Specification
The use of terms for various fluorophores, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Specifically, the following trade names appear at least on p. 10 at para. 1: Cy3 and Cy5.
Claim Interpretation
Claim 1 recites, in part, a nucleic acid aptamer which specifically binds to certain Cronobacter spp.
The instant specification defines an aptamer as “a nucleic acid molecule that has a stable tertiary structure and can bind to target substances … with specificity and affinity” (p. 6, para. 4). The instant specification also teaches that “specifically bind[s]” means that “the aptamer does not substantially bind to microorganisms other than [the target microorganisms]” (p. 6, para. 5).
It is further understood in the art that the aptamer three-dimensional structure comprises surfaces with binding sites that are complementary in shape and charge to the desired target”.1
Thus, the claim 1 aptamer is being construed as at least one of the nucleic acid
sequences of SEQ ID NOs: 1-4, which adopts a particular three-dimensional structure and which structure has binding sites that are complementary to the desired target. This type of “specific[] binding” is in contrast to the “specific binding” that occurs when two single-stranded linear nucleic acids with complementary sequences hybridize to one another as, e.g., in PCR.
Claim Rejections - 35 USC § 112
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 4 and 7 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 7 recites the limitation “[a] kit for detecting Cronobacter”, which is a statement of
intended use. Since the recited kit for detecting Cronobacter need not have any components in addition to the aptamer(s) recited in claim 1, and since the specification does not define “kit” in such a way as to require any additional components, the statement of intended use does not result in a structural difference in the claim 1 aptamer, and thus claim 7 does not further limit claim 1. Consequently, claim 7 is in improper dependent form. Claim 4 similarly recites the statement of intended use “[a] composition for multi-detection of Cronobacter” and is rejected with corresponding reasoning with “composition” analyzed in the same manner as “kit”.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Prior Art and Patent Eligibility
The closest prior art is Kim2 (Specific detection of Cronobacter sakazakii in powdered infant formula using ssDNA aptamer, Analyst, 146(11): 3534-3542, June 2021). Kim teaches a method of detecting C. sakazakii in packaged food products, and, in particular in infant formula (section 1). More specifically, Kim describes a method for screening a library of aptamers which resulted in identifying an aptamer that specifically binds to C. sakazakii (Fig. 1; section 3.3). However, neither Kim nor any other art teaches or suggests any of SEQ ID NOs: 1-4 in the form of a stable three-dimensional structure with binding sites that are complementary to and specific for the recited targets.
Therefore, independent claim 1 and its dependent claims are free of the art.
Claims 1-9 and 12-14 are patent eligible because each of the aptamers recited in claim 1, which comprise at least one of SEQ ID NOs: 1-4 and which have a stable three-dimensional structure with binding sites that are complementary to and specific for the recited targets, are not naturally occurring molecules.
Claims 1-3 are allowed.
Claims 4 and 7 are free of the art, but stand rejected under 35 USC § 112, as noted above.
Claims 5-6, 8-9 and 12-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1-9 and 12-14 are being examined. Claims 1-3 are allowed. Claims 4 and 7 are rejected. Claims 5-6, 8-9 and 12-14 are objected to, but are otherwise directed to allowable subject matter.
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 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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/CAROLYN L GREENE/Primary Examiner, Art Unit 1681
1 Yu (Aptamers can Discriminate Alkaline Proteins with High Specificity, Chembiochem, 12(17): 2659-2666, 2011): p. 1, para. 2).
2 Kim was cited in the Information Disclosure Statement submitted December 17, 2024.