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 .
DETAILED ACTION
1. Claims 1, 5 are amended. Claim 3 is canceled. New claims 7, 8 are added. Claims 1, 2, 4-8 are under consideration.
Declaration Submission
2. The Declaration under 37 CFR 1.132 filed 10/29/2025 is sufficient to overcome the rejection of claims 1-6 as indicated below.
Claim Objections
3. (previous objection, withdrawn as to claim 5; maintained as to claim 1; new as to claim 8) Claim 1, 8 are objected to because of the following informalities:
Applicant contends: claim 1 is amended to correct the spelling of “promotor”; claim 5 is amended.
Applicant’s arguments are considered and found persuasive as to claim 5, but unpersuasive as to claim 1.
See the objection as recited in the previous Office Action.
It is noted claim 1 still recites “promotor” in line 7. The objection is maintained.
As to new claim 8, for improved clarity, the claim should recite “AGGT”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
4. (previous rejection, withdrawn) Claims 1-6 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and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.
Applicant contends: a Declaration under 1.132 as been submitted to provided more detailed explanations and terminology; claim 1 has been amended; paragraph [0083] explains “allows for”; claim 1 is amended as to “a gene product of the reporter sequence”; “designed to be capable of” is explained by the application as filed; the comma has been deleted; paragraph [0083] explains “allows for”; claim 3 is canceled; paragraph [0082] teaches synthesis of the reporter (-) strand DNA occurs when replication of HBV progresses, thereby the amount of the reporter (-) strand DNA reflect replication activity of HBV.
In view of applicant’s amendments and the submission of the Declaration under 37 CFR 1.132, the rejection is withdrawn.
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.
5. (new, necessitated by amendment) Claims 1, 2, 4-8 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.
See claims 1, 2, 4-8 as submitted 10/29/2025.
As to claim 1, the amended claim recites “a primer pair consisting of a forward primer and a reverse primer which is designed to be capable of detecting the reporter sequence in reporter minus strand DNA”. It is not clear if “which is” refers to the primer pair or just the reverse primer, of it the claim intends to recite “of a forward primer and a reverse primer which are…”, or “… a forward primer and a reverse primer, either of which is designed…”.
Further as to amended claim 1, the claim recites “the 2 to 3 nucleotides in the elongation direction”. There is insufficient antecedent basis for this limitation in the claim.
Further as to new claim 7, it is not clear what “design only the 2 to 3 nucleotides at the 3’ terminal side thereof match to the 2 to 3 nucleotides” means.
Conclusion
6. No claims are allowed.
7. 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 M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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, Thomas Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
Prosecution Insights