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 .
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 14, 2025 has been entered. Applicant’s remarks and amendments have been fully and carefully considered but are not found to be sufficient to put the application in condition for allowance. Any rejections or objections not reiterated herein have been withdrawn.
Claims 12-29, 32, 34, and 36-40 are currently pending.
Claims 12-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 reply filed on October 11, 2024.
Claim Rejections - 35 USC § 112
3. 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 29, 32, 34, and 36-40 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. This is a new matter rejection.
In the instant case the specification does NOT appear to provide support for the amendment of claim 29 to recite:
ii. at least one labelled probe comprising SEQ ID NO: 16, a 5' end fluorescent reporter, and a 3' end quencher;
iii. at least one labelled probe comprising SEQ ID NO: 17, a 5' end fluorescent reporter, and a 3' end quencher;
The specification has been reviewed for support for the claims as amended. The specification teaches the following:
[0055] In yet another preferred embodiment of the first or second aspect of the invention or of any of the preferred embodiments of the invention, the amplification reaction is carried out by means of a real-time polymerase chain reaction. Preferably, the detection of the amplification product is carried out by means of a fluorescent intercalating agent. Even more preferably, the detection of the amplification product(s) is carried out by means of a labeled probe, wherein the probe preferably comprises at its 5′ end a reporter pigment and at its 3′ end a “quencher” pigment or silencer or buffering agent. Preferably, in the case of Bilophila, the amplification reaction is carried out by using the following primers of SEQ ID NO 16 and 17:
Bil1 F GGT ATG TTC GAT CCG GCT ATC
R TGT TTT CCC GAC CAT CTT CC
While the specification discloses performing an amplification reaction using SEQ ID NOs: 16 and 17 as primers, the specification does not provide specific support for using SEQ ID NOs: 16 and 17 as probes to detect an amplification product. Further the specification does not teach that SEQ ID NOs: 16 and 17 may comprise a 5' end fluorescent reporter and a 3' end quencher.
The written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations that are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (an adequate description of a genus may not support claims to a subgenus or species within the genus).
Requirement for Information
4. Applicant and the assignee of this application are required under 37 CFR 1.105 to provide the following information that the examiner has determined is reasonably necessary to the examination of this application.
Claim 29 has been amended to recite:
ii. at least one labelled probe comprising SEQ ID NO: 16, a 5' end fluorescent reporter, and a 3' end quencher;
iii. at least one labelled probe comprising SEQ ID NO: 17, a 5' end fluorescent reporter, and a 3' end quencher;
The required information is as follows:
a. Please disclose if SEQ ID NO: 16 has the same nucleotide sequence as a naturally occurring Bilophila nucleic acid sequence. If so, how did the inventors get possession of this naturally occurring Bilophila nucleic acid sequence.
b. Please provide details on how the inventors designed the primer of SEQ ID NO: 16.
c. Please describe how the primers of SEQ ID NOs: 16 and 17 relate to the target Bilophila regions of SEQ ID NOs: 10-12. If possible, please provide an alignment showing how the primers are able to amplify the regions comprising SEQ ID NOs: 10-12.
The applicant is reminded that the reply to this requirement must be made with candor and good faith under 37 CFR 1.56. Where the applicant does not have or cannot readily obtain an item of required information, a statement that the item is unknown or cannot be readily obtained may be accepted as a complete reply to the requirement for that item.
This requirement is an attachment of the enclosed Office action. A complete reply to the enclosed Office action must include a complete reply to this requirement. The time period for reply to this requirement coincides with the time period for reply to the enclosed Office action.
5. Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA HANEY whose telephone number is (571)272-8668. The examiner can normally be reached Monday-Friday, 8:15am-4:45pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Shen can be reached on 571-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA HANEY/Primary Examiner, Art Unit 1682