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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/12/2025 has been entered.
Status of the Claims
The amendment filed 8/12/2025 has been entered. Claims 6, 10, and 17 have been amended. Claims 1-17 are currently pending, and claims 6-10 and 16-17 are examined herein.
Status of the Rejection
Applicant’s amendments to the claims have overcome various rejections previously set forth in the Final Rejection filed 5/22/2025.
All 35 U.S.C. § 103 rejections from the previous office action are withdrawn in view of the Applicant’s amendment.
New claim objections and grounds of rejection under 35 U.S.C. § 112(a) and 112(b) are necessitated by the amendments as outlined below.
Claim Objections
Claims 6 and 16-17 are objected to because of the following informalities:
In claim 6 lines 11-12, “no more than + 5 % when the concentration of an agarose gel is changed from 0.8 % w/v to 3 % w/v” should be amended to -- no more than +5% 0.8% w/v to 3% w/v
In claim 6 line 15, “a nucleic-acid fragment of a target base length” should be amended to --a nucleic-acid fragment of the nucleic acid sample of a target base length--.
In claim 6 line 17, “the nucleic acid” should be amended to --the nucleic acid sample--.
In claim 6 line 23, “the portion[“ should be amended to --the portion
In claim 16 line 3, “an electrophoresed sample” should be amended to --[[an]] the electrophoresed sample--.
In claim 17 lines 3-4, “a nucleic acid fragment of the nucleic acid sample of a target base length” should be amended to --[[a]] the nucleic acid fragment of the nucleic acid sample of [[a]] the target base length--.
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 6-10 and 16-17 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 6 recites “a molecular-weight marker […] that comprises a linear inorganic polyphosphate salt having 50 to 500 phosphate repeat units and a number-average molecular weight of 5 kDa to 50 kDa” in lines 4-8. While the molecular-weight marker comprising a linear polyphosphate salt is taught in the instant specification (“Examples of the homopolymer that can be used as the molecular weight marker for electrophoresis of the present embodiment include a polyphosphoric acid […] and salts or derivatives thereof,” para. [0030, 0035]), there is no mention in the specification of the number of phosphate repeat units or the molecular weight in kDa of a polyphosphate salt molecular-weight marker. Thus, this limitation is deemed to be new matter.
Claim 6 further recites “exhibiting an electrophoretic mobility that varies by no more than + 5 % when the concentration of an agarose gel is changed from 0.8 % w/v to 3 % w/v” in lines 11-12. There is no mention in the instant specification regarding the change in electrophoretic mobility of a phosphate salt in an agarose gel with an adjusted concentration. Thus, this limitation is deemed to be new matter.
Claim 6 further recites “determining a position in the lane of the electrophoresed sample that matches a predetermined position […] cutting out a portion of the lane that contains the molecular-weight marker at the predetermined position” in lines 19-22. There is no mention in the instant specification of a “predetermined position” of the sample or that the position of the electrophoresed sample would be known before electrophoresis. Thus, this limitation is deemed to be new matter.
Claims 7-10 and 16-17 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of claim 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 6-10 and 16-17 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 6 recites “determining a position in the lane of the electrophoresed sample that matches a predetermined position” in lines 19-20. In light of the specification, it is unclear how the position of the electrophoresed sample is “predetermined.” Claims 7-10 and 16-17 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 6.
Claim 7 recites the limitation "the polyelectrolyte" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the polyelectrolyte" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the polyelectrolyte" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the polyelectrolyte" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the polyelectrolyte" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Response to Arguments
Applicant's arguments, see Remarks pgs. 7-13, filed 8/12/2025, with respect to the 35 U.S.C. § 103 rejections have been fully considered, and all 35 U.S.C. § 103 rejections from the previous office action are withdrawn in view of the Applicant’s amendment. However, applicant’s arguments are moot in view of the new grounds of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLEE Y TSENG whose telephone number is (703)756-5542. The examiner can normally be reached Mon - Fri 9-6 PT.
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/K.T./Examiner, Art Unit 1795
/LUAN V VAN/Supervisory Patent Examiner, Art Unit 1795
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