DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Status of the Application
2. Applicant's response filed on June 17, 2026 has been entered.
Claims 34-38 and 60-70 are pending.
Claims 34-38, 61-64, and 66-68 are under examination. Claims 60, 65, 69, and 70 remain withdrawn as being drawn to a non-elected invention, but will be considered for rejoinder in accordance with MPEP 821.04 when the elected invention is allowable.
Response to Arguments
3. Applicant’s arguments filed on June 17, 2026 have been fully considered.
Objection to claim 64
Applicant argues that the objection to claim 64 should be withdrawn in view of the amendments to the claim, which adopt the suggestions made in the last Office action (Remarks, page 1).
This argument was persuasive. The objection has been withdrawn.
Rejection of claims 34-38, 61-64, and 66-68 under pre-AIA 35 U.S.C. 112, first paragraph (new matter)
Applicant argues that the rejection should be withdrawn in view of the amendments to claims (Remarks, page 2). Applicant’s response also points to paras. 25 and 47 as providing support for the subject matter of the amended claims (Remarks, page 1).
These arguments and the cited portions of the original disclosure have been fully considered and were persuasive in part. More specifically, Applicant’s argument was persuasive with respect to the issue of the 5’ extended probe tail in claims 34, 61-63, and 64. That basis for rejection has been withdrawn. Applicant’s argument was not persuasive with respect to the length of the isolated nucleic acid recited in claims 34-38 and 61-63 because, as discussed in the modified rejection, these claims still encompass longer nucleic acids that are not supported by the original disclosure. Applicant’s argument was also not persuasive with respect to claims 67 and 68 because those claims still recite 5’ extended probe tail sequences that are not supported by the original disclosure. Thus, claims 34-38, 61-63, 67, and 68 remain rejected under 35 U.S.C. 112, first paragraph for containing new matter.
Rejection of claims 63 and 66 under pre-AIA 35 U.S.C. 112, second paragraph
Applicant argues that the rejection of claim 63 should be withdrawn in view of the amendments to that claim (Remarks, page 2). Applicant also argues that the rejection of claim 66 should be withdrawn because the claim is, in fact, clear and definite.
These arguments were persuasive. The rejection has been withdrawn.
Rejection of claim 66 under pre-AIA 35 U.S.C. 112, fourth paragraph
Applicant argues that the rejection should be withdrawn (Remarks, page 2).
Applicant’s arguments on page 2 have been considered. The rejection has been withdrawn because upon further consideration claim 66 is further limiting. More specifically, claim 66 requires the first oligonucleotide to contain SEQ ID NO: 4 in addition to meeting the requirements of claim 64, from which it depends. An example of such an oligonucleotide is shown in para. 117 on page 28 of the clean copy of the substitute specification filed on January 7, 2026, where the second Scorpion primer contains SEQ ID NO: 28 at the 5’ end and SEQ ID NO: 4 at the 3’ end.
Claim Interpretation
4. Several claims under examination use the transitional phrase “having” or “has.” See claims 34 and 61-64. As discussed in MPEP 2111.03 IV, the transitional phrase “having” (or has) must be interpreted in light of the specification to determine whether open (comprising) language or closed (consisting of) language is intended.
In this case, claims 34, 61, 62, and 64 use the transitional phrase “has” to describe the 5’ extended probe tail sequence. See the last two lines of claim 34 and the last three lines of claim 64, where the claims recite “wherein the 5’ extended probe tail has SEQ ID NO: 13 or the complement thereof, or SEQ ID NO: 28 or the complement thereof.” Claims 61 and 62 use the same language to describe SEQ ID NO: 13 and its complement or SEQ ID NO: 28 and its complement, respectively. This use of the transitional phrase “has” in claims 34, 61, 62, and 64 is treated as closed (i.e., equivalent to “consisting of”) since the specification does not contain anything to indicate that broader language was contemplated for the sequences described with “has” (see, e.g., para. 30 of the clean copy of the substitute specification filed on January 7, 2026).
In claim 63, the transitional phrase “has” is used to describe a particular portion of the 5’ extended probe tail. This use of the transitional phrase “has” is treated as closed (i.e., equivalent to “consisting of”) since the specification does not contain anything to indicate that broader language was contemplated for the sequences described with “has” (see, e.g., para. 30 of the clean copy of the substitute specification filed on January 7, 2026).
Claim 64 additionally uses the transitional phrase “having” to describe a particular nucleic acid. More specifically, the claim recites, “a first oligonucleotide that specifically hybridizes to a nucleic acid having the sequence of SEQ ID NO: 2, or a complement thereof” in lines 1-2. This use of the transitional phrase “having” in claim 64 is treated as open (i.e., equivalent to “comprising”) because the disclosure is directed to nucleic acids capable of hybridizing to the IS481 sequence of Bordetella pertussis, of which SEQ ID NO: 2 is a part (see, e.g., paras. 9-11, 22, 34, 64, and 91 of the originally filed specification).
Claim Rejections - 35 USC § 112(a) (New Matter)
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 34-38, 61-63, 67, and 68 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 34
Claim 34 has been amended such that it is drawn to “An isolated nucleic acid comprising a primer between about 10 and about 100 nucleotides in length that is at least 95% identical in sequence to SEQ ID NO: 2, or a complement thereof.” The isolated nucleic acid also contains a 5’ extended probe tail comprising a hairpin structure that includes a fluorophore/quencher pair. Further, the 5’ extended probe tail has SEQ ID NO: 13 or its complement or SEQ ID NO: 28 or its complement.
Applicant’s response states that support for the claimed nucleic acid may be found at, for example, paras. 25 and 47 of the clean copy of the substitute specification filed on January 7, 2026 (Remarks, page 1).
The original disclosure, including the portions cited by Applicant, has been reviewed, but support was not found for the full scope of the isolated nucleic acids encompassed by amended claim 34. More specifically, the use of “comprising” in the preamble of the claim causes the claim to still encompass nucleic acids that are much longer than the lengths disclosed in the original disclosure for primers, probes and Scorpion™ primers. Put another way, the upper limit for the length of the isolated nucleic acid in claim 34 remains open-ended because of the presence of “comprising” in the preamble.
The original disclosure is much more limited, however, compared to the claim scope. More specifically, specific examples within the claimed genus are disclosed in para. 117 of the substitute specification on January 7, 2026, but these nucleic acids are only 48 or 50 nucleotides in length, and there is nothing to suggest that the much longer nucleic acids encompassed by claim 34 were contemplated. Para. 47 of the substitute specification filed on January 7, 2026 states that primers may be about 10-100 nucleotides in length, and para. 93 of this substitute specification discloses particular primers and probes useful for amplifying SEQ ID NO: 2. Neither of these paragraphs provides support for the full scope of claim 34, though, which as noted above, encompasses much longer nucleic acids. Para. 25, also cited in Applicant’s response, does not remedy this deficiency because it only relates to the 5’ extended probe tail sequences of SEQ ID NO: 13 or its complement, or SEQ ID NO: 28 or its complement. Thus, amended claim 34 still contains new matter.
Claims 35-38 and 61-63
These claims depend directly or indirectly from claim 34 and further describe the primer portion or 5’ extended probe tail portion of the isolated nucleic acid of claim 34. As with claim 34, these dependent claims still use open language to describe the isolated nucleic acid, and thus encompass nucleic acids with a total length much longer than the original disclosure supports. Accordingly, amended claims 35-38 and 61-63 still contain new matter.
Claims 67 and 68
Claims 67 and 68 each depend from claim 64 and state, respectively, that the 5’ extended probe tail “comprises the sequence of SEQ ID NO: 13 or the complement thereof” or “comprises the sequence of SEQ ID NO: 28 or the complement thereof.” These claims contain new matter because the original disclosure only provides support for “a 5’ extended probe tail that has the sequence of SEQ ID NO: 13 or a complement thereof” or “a 5’ extended probe tail that has the sequence of SEQ ID NO: 28 or a complement thereof” (see, e.g., para. 30 of the substitute specification filed on January 7, 2026).
Claim Rejections - 35 USC § 112
6. 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 37, 38, and 63 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.
Claims 37 and 38 each depend from claim 36 and recite, respectively, “wherein said primer is identical in sequence to SEQ ID NO: 3” and “wherein said primer is identical in sequence to the complement of SEQ ID NO: 3.”
Claim 36 requires the primer to be “between about 13 and about 25 nucleotides in length.” SEQ ID NO: 3, though, is much longer at 86 nucleotides. As a result, claims 37 and 38 encompass nucleic acids excluded by claim 36, and the claims fail to comply with 35 U.S.C. 112(d) for this reason. One way to address this issue would be to amend claims 37 and 38 such that they each depend from claim 34.
Claim 63 depends from claim 34 and recites “wherein the 5’ extended probe tail has a sequence that is complementary to and hybridizes to an amplicon generated from extension of the nucleotide sequence.” This is not further limiting because it is already required by claim 34. More specifically, SEQ ID NO: 13, SEQ ID NO: 28, and their complements recited in claim 34 already possess the property recited in claim 63 (see paras. 69, 92, and 117 of the clean copy of the substitute specification filed on January 7, 2026).
Applicant may cancel the claims, amend the claims to place them in proper dependent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
Allowable Subject Matter
7. Claims 64 and 66 are allowed.
Conclusion
8. Claims 34-38, 61-63, 67, and 68 are rejected. Claims 64 and 66 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 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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/ANGELA M. BERTAGNA/Primary Examiner, Art Unit 1681
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