DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s response filed on May 4, 2026 has been entered.
Claims 1-18, 22, 24, and 26-30 are pending.
Claims 1, 2, 4, 5, 12, and 30 are under examination. As noted previously, Applicant has elected “Species A and SEQ ID NO: 1” for examination.
Claim 3 is newly withdrawn in view of the amendments to the claim, which cause it to be drawn to a non-elected species.
Claims 6-11, 13-18, 22, 24, and 26-29 remain withdrawn from consideration as being drawn to a nonelected invention.
Response to Arguments
3. Applicant’s arguments filed on May 4, 2026 have been fully considered.
Objection to the Specification
Applicant argues that the objection should be withdrawn in view of the specification amendment filed with the response (Remarks, page 8).
This argument was persuasive. The objection has been withdrawn.
Claim Objections
Applicant argues that the objections to claims 1, 3, 4, and 12 should be withdrawn in view of the claim amendments (Remarks, page 8).
This argument was persuasive. The objections have been withdrawn.
Rejection of claims 1-5, 12, and 30 under 35 U.S.C. 101
Applicant argues that the rejection should be withdrawn in view of the amendments to claims 1, 2, and 12 (Remarks, page 8).
This argument was persuasive. The rejection has been withdrawn.
Rejection of claims 2-5, 12, and 30 under 35 U.S.C. 112(b)
Applicant argues that the rejection should be withdrawn in view of the amendments to claims 2, 5, and 30 (Remarks, page 9).
In response, Applicant’s argument was persuasive with respect to claims 2, 4, and 5. The rejection has been withdrawn with respect to those claims.
As to claim 3, Applicant’s argument is moot since the claim is now withdrawn because the amendments cause it to be drawn to a non-elected species.
As to claim 12, Applicant’s response does not address the claim, and the amendments do not address all of the issues raised previously. Further, the amendment to claim 12 creates a new indefiniteness issue. Accordingly, claim 12 remains rejected under 35 U.S.C. 112(b).
As to claim 30, Applicant’s argument was persuasive. The indefiniteness issues raised previously are moot in view of the amendments to claim 30, but the amendments also create a new indefiniteness issue, which is discussed below. Accordingly, claim 30 remains rejected under 35 U.S.C. 112(b), but for a different reason.
Rejection of claims 1-5 and 12 under 35 U.S.C. 102(a)(1) as being anticipated by Ohba
Applicant argues that the rejection should be withdrawn in view of the amendments to claim 1 (Remarks, pages 9-10).
This argument was persuasive. The rejection has been withdrawn because the Pag313 primer of Ohba does not include a non-naturally occurring detectable label as required by amended claim 1.
Rejection of claims 1-5, 12, and 30 under 35 U.S.C. 102(a)(1) as being anticipated by Azzazy
Applicant argues that the rejection should be withdrawn in view of the amendments to claim 1, which require the oligonucleotide to contain a non-naturally occurring detectable label (Remarks, pages 9-10).
This argument was not persuasive because Azzazy does teach that the disclosed oligotargeters, which include SEQ ID NO: 196 discussed in the rejection, may contain a 5’ detectable label (e.g., FAM) (see paras. 87, 189, 203). Thus, Azzazy still teaches all of the elements of the rejected claims, and the rejection is maintained with modifications to address the claim amendments.
Double Patenting
Applicant argues that the provisional rejection made previously citing co-pending Application Serial No. 17/920,571 is moot since the ‘571 application has been abandoned (Remarks, page 10).
This argument was persuasive. The rejection has been withdrawn.
Claim Interpretation
4. The elected oligonucleotide, SEQ ID NO: 1, contains two variable positions: (i) R, which may be A or G, at position 9; and (ii) Y, which may be C or T, at position 17. Since independent claims 1, 2, 12, and 30 recite “an oligonucleotide” or “a primer,” they are considered to encompass oligonucleotides in which one of the options for each variable position is satisfied. In other words, the claims are not interpreted as requiring a mixture of all four possible oligonucleotides encompassed by SEQ ID NO: 1, and are interpreted as encompassing single oligonucleotides that contain one of the permitted options at each variable position.
Claim Rejections - 35 USC § 112
5. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 4, 5, 12, and 30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to require the isolated oligonucleotide to contain “a non-naturally occurring detectable label.”
Claims 2, 4, and 5 are drawn to a composition comprising “at least one oligonucleotide of claim 1.”
Claims 12 and 30 are drawn to a composition and kit, respectively, comprising “at least one primer of claim 1” (claim 12) or “one or more primers of claim 1” (claim 30).
Thus, all of the claims under examination require an isolated oligonucleotide containing a non-naturally occurring detectable label.
Applicant’s response does not point to any particular portion(s) of the original disclosure as providing support for this new requirement in claim 1.
The original disclosure has been reviewed, but support was not found for an isolated oligonucleotide containing the sequence features set forth in claim 1 as well as a non-naturally occurring detectable label. The specification discloses a labeled probe (p. 21, para. 62), but this probe is not required to have the sequence features set forth in claim 1. The specification also describes labels in the context of lateral flow assays and sandwich assays (pp. 30-33), but there is nothing in this portion of the specification to support the subject matter of the amended claims, which require an isolated oligonucleotide containing the sequence features set forth in claim 1 as well as a non-naturally occurring detectable label. Accordingly, claims 1, 2, 4, 5, 12, and 30 are rejected under 35 U.S.C. 112(a) for containing new matter.
Claim Rejections - 35 USC § 112
6. 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 12 and 30 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 12
Claim 12 is indefinite because it is unclear how a microbe can be any combination of bacteria, mycobacteria, babesia, and/or fungi as recited in lines 1-2 since a microbe (singular) would necessarily fall into just one of the aforementioned categories, with the exception of mycobacteria, which are a particular type of bacteria. Applicant could address the issue by amending the claim to recite, for example, “A composition for detecting bacteria, mycobacteria, babesia, fungi, or any combination thereof.”
Claim 12 is also indefinite because it refers in line 3 to “at least one primer of claim 1,” but claim 1 does not require the recited oligonucleotide to be a primer. Accordingly, there is a lack of clear antecedent basis for “at least one primer of claim 1” as recited in claim 12.
Claim 30
Claim 30 is indefinite because it refers in line 2 to “one or more primers of claim 1,” but claim 1 does not require the recited oligonucleotide to be a primer. Accordingly, there is a lack of clear antecedent basis for “at least one primer of claim 1” as recited in claim 30.
Claim Rejections - 35 USC § 102
7. 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.
8. Claims 1, 2, 4, 5, 12, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Azzazy et al. (US 2014/0356859 A1; cited previously).
Regarding claims 1, 2, and 4, Azzazy discloses an isolated oligonucleotide, SEQ ID NO: 196, that comprises the instant SEQ ID NO: 1 plus three additional nucleotides at the 5’ end and five additional nucleotides at the 3’ end (p. 48, para. 402). As well, regarding the amendment to claim 1, Azzazy also teaches that the disclosed oligotargeters, which include SEQ ID NO: 196, may contain a 5’ detectable label (e.g., FAM) (see paras. 87, 189, and 203). Azzazy further teaches that SEQ ID NO: 196 may be provided in a composition together with reagents for detecting mycobacteria (paras. 82-91 and 97-100). As noted previously, the claims do not require a mixture of all four oligonucleotides encompassed by the variable positions and embrace a single oligonucleotide, provided that the single oligonucleotide contains one of the two possible options at each variable position. In this case, SEQ ID NO: 196 of Azzazy meets this requirement. Thus, Azzazy anticipates the isolated oligonucleotide of claim 1 as well as the compositions of claims 2 and 4.
Regarding claim 5, the composition of Azzazy is used to detect bacterial nucleic acids (see, e.g., para. 402 and also paras. 82-91 and 97-100).
Regarding claim 12, as discussed above, SEQ ID NO: 196 of Azzazy comprises the instant SEQ ID NO: 1 plus three additional nucleotides at the 5’ end and five additional nucleotides at the 3’ end (p. 48, para. 402). This oligonucleotide may also contain a non-naturally occurring detectable label (see, e.g., paras. 87, 189, and 203). As also discussed above, Azzazy further teaches providing this oligonucleotide in a composition together with reagents for detecting mycobacteria (paras. 82-91 and 97-100). Azzazy does not state that SEQ ID NO: 196 is a primer, but as can be seen in para. 402, the oligonucleotide of SEQ ID NO: 196 is not blocked at the 3’ end nor is it too long to function as a primer. Therefore, Azzazy also anticipates the composition of claim 12.
Regarding claim 30, Azzazy teaches that the disclosed SEQ ID NO: 196, which as noted above meets the requirements of “a primer,” may be provided in a kit (paras. 125-129). The kit of Azzazy may also include reaction containers (para. 204). These containers meet the requirement in claim 30 for the kit to contain “a compartment adapted to contain one or more primers of claim 1.” Thus, Azzazy anticipates the kit of claim 30.
Conclusion
9. No claims are currently allowable.
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 Angela Bertagna whose telephone number is (571)272-8291. The examiner can normally be reached 8-5, M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANGELA M. BERTAGNA/Primary Examiner, Art Unit 1681
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