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 Claims
The Amendment filed December 19, 2025 has been entered. Claims 6-8 and 16-17 have been amended; claims 18-22 are new; claims 1-5 and 11-15 have been withdrawn previously; and claims 9-10 have been cancelled. Claims 6-8 and 16-22 are currently examined herein.
Status of the Rejection
Applicant’s amendments to the Claims have overcome each objection and 112(a) and 112(b) rejections previously set forth in the Non-Final Office Action mailed October 6, 2025.
New grounds of claim objection are necessitated by the amendment as outlined below.
New grounds of rejection under 35 U.S.C. § 112(a) and 112(b) are necessitated by the amendment as outlined below.
Claim Objection
Claims 6 and 17 are objected to because of the following informalities:
Claim 6: please amend “a DNA polymerase chain reaction that comprises” to -- a DNA polymerase chain reaction, wherein the molecular-weight marker [[that]] comprises--.
Claim 17: please amend “a same mobility as a mobility of the nucleic acid fragment of the nucleic acid sample of the target base length” to – [[a]] the same mobility as [[a]] the mobility of the nucleic acid fragment of the target base length [[of]] in the nucleic acid sample --.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 7 and 22 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 7 recites “wherein the polyphosphoric acid is a linear polyphosphoric acid”, and the instant specification discloses “a linear polyelectrolyte may be used” [para. 0035] in PG-Pub, and does not support that the polyphosphoric acid is a linear polyphosphoric acid. Therefore, claim 7 is a new matter.
Claim 22 recites “a 3% (w/v) agarose gel” and “a 0.5% (w/v) toluidine blue aqueous solution”. The instant specification discloses “The agarose gel was prepared by pouring 3% SeaKem (registered trademark) GTG-TAE (manufactured by Lonza KK.) into a plastic container and molding it” [para. 0064] in PG-Pub, and “ 0.5% toluidine blue aqueous solution” [para. 0080] in PG-Pub. The specification does not support the unit of “(w/v)” in “3% (w/v)” and “0.5% (w/v)”. Therefore, claim 22 is a new matter.
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 6-8 and 16-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Regarding claim 6, claim 6 recites “a nucleic acid sample containing nucleic acid fragments of various base lengths”, “a nucleic acid having a specific base length” and “a nucleic-acid fragment of a target base length”. It is unclear if “a nucleic-acid fragment of a target base length” is the same as or different than “a nucleic acid having a specific base length”. It is unclear if “a nucleic acid having a specific base length” and “a nucleic-acid fragment of a target base length” are parts of the nucleic acid fragments of various base lengths in the nucleic acid sample. Thus, the scope of claim 6 is indefinite. Claims 7-8 and 16-22 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 6.
Regarding claim 18, claim 18 recites “the nucleic acid”, which lacks antecedent basis, and it is unclear if it refers to the nucleic acid having a specific base length, the nucleic-acid fragment of a target base length, or nucleic acid fragments of various base lengths. Therefore, the scope of claim 18 is indefinite.
Regarding claim 22, claim 22 recites “SeaKem GTG”, which is a registered trademark. If the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). [MPEP 2173.05(u)]. Therefore, the scope of claim 22 is indefinite.
Response to Arguments
Applicant's arguments, see Remarks Pgs. 8-13, filed 12/19/2025, with respect to the claim objection, 35 U.S.C. § 102(a) and 35 U.S.C. § 112(b) rejections have been fully considered, and the claim objection, 112(a) and 112(b) rejections from the previous office action are withdrawn.
Conclusion
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 SHIZHI QIAN whose telephone number is (571)272-3487. The examiner can normally be reached Monday-Thursday 8:00 am-5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan V Van can be reached on 571-272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIZHI QIAN/Primary Examiner, Art Unit 1795
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