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 Application
The Amendment and Response filed March 31, 2026 is acknowledged.
Claims 1-23 were pending. Claims 11-21, 23 and new claims 24-33 are being examined on the merits. Claim 22 is canceled. Claims 1-10 were withdrawn and are now canceled.
Response to Arguments
Applicant’s arguments filed March 31, 2026 have been fully considered.
The following objections and rejections are WITHDRAWN in view of Applicant’s arguments and claim amendments:
Objections to claims 17 and 21
Rejection of claims under 35 USC § 101
Prior art rejections
Claim Interpretation
The specification recites that an “adulterant” is an “unwanted substance[]” that “can be added to the processed botanical material accidently, negligently, or intentionally” (para. 83). The specification also recites that a “non-target” species is an “adulterant” (para. 85). Thus, the terms “adulterant” and “non-target species” are interpreted as having the same meaning.
Claim 23 recites, in part, “a sequence as set forth in SEQ ID NO: 31 or 33” and “a sequence as set forth in SEQ ID NO: 32 and 34”. Both the sequence listing and the specification indicate that SEQ ID NOs: 31 through 34 comprise nucleotides with phosphorothioate linkage modifications (Example 3, p. 40). Thus, the phrase “a sequence as set forth in SEQ ID NO: [31/32/33/34]” is being interpreted as requiring both the corresponding recited linear nucleotide sequence and the phosphorothioate modifications. This is in contrast to instant SEQ ID NOs: 29 and 30 which have the same linear nucleotide sequences as SEQ ID NOs. 31 and 33, and 32 and 34, respectively, but do not comprise the phosphorothioate modifications.
Claim Objections
Claim 23-33 is objected to because of the following informalities:
In claim 23, the limitation “SEQ ID NO: 31 or 33 complementary to …” should be “SEQ ID
NO: 31 or 33 that is complementary to …”, and the limitation “SEQ ID NO: 32 or 34 complementary to …” should be “SEQ ID NO: 31 or 33 that is complementary to …”.
Claims 24-33 are objected to for incorporating the informalities of claim 23.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 30 is 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 30 recites the limitation "the DNA polymerase" in l. 1. There is insufficient antecedent basis for this limitation in the claim. Claim 23, from which claim 30 depends, does not recite a DNA polymerase.
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 19-21 and 26-28 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.
Claim 19 recites the limitation that the processed botanical material is a ginseng root material, while claim 20 recites specifically P. ginseng or Petroselinum crispum. Claim 21 recites various non-target species, e.g., P. quinquefolius and P. notoginseng. Claim 11, from which each of claims 19-21 depends, requires that the system comprises an inner forward primer of SEQ ID NO: 12 and an inner reverse primer of SEQ ID NO: 13. However, referring to instant Fig. 2, which depicts a consensus sequence of P. ginseng and several non-target species, SEQ ID NOs: 12 and 13 (specification, p. 45, and sequence listing) are different embodiments of the inner reverse primer sequence. Thus, at least as to a system for distinguishing P. ginseng from at least some non-target species, SEQ ID NOs: 12 and 13 are not a forward and reverse primer pair, as required by claim 11. Consequently, there are at least some embodiments of claims 19-21 that do not further limit claim 11, and are in improper dependent form.
Claim 26 recites that “the inner forward primer and/or inner reverse primer have a … 3’
end phosphorothioate bonds modification …”. Claim 23, from which claim 26 depends, requires a primer pair of SEQ ID NOs: 31 or 33 and SEQ ID NOs: 32 or 34. As noted in the instant specification, SEQ ID NOs: 31 and 32 have 4 phosphorothioate bond modifications, while SEQ ID NOs: 33 and 34 have 3 phosphorothioate bond modifications (pp. 47-48). Thus, to the extent that claim 26 is directed to embodiments that only require phosphorothioate bond modifications, these embodiments do not further limit claim 23. Consequently, claim 26 is in improper dependent form. Claim 27 recites that the inner forward and/or inner reverse primer have 1-9 3’ end phosphorothioate bond modifications. To the extent that claim 27 is directed to embodiments that require fewer than the corresponding number of phosphorothioate bond modifications required in SEQ ID NOs: 31-34, these embodiments do not further limit claim 23, and claim 27 is in improper dependent form. Claim 28 similarly recites that the inner forward and/or inner reverse primer have 4 consecutive 3’ end phosphorothioate bond modifications. Claim 28 is rejected with analogous reasoning as claims 26 and 27.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Prior Art
Regarding claims 11 and 23, the following art1 is relevant: GenBank Accession No. DQ500902.1 (Polianthes longiflora tRNA-Leu (trnL) gene, intron; chloroplast, 2006); GenBank Accession No. HQ917115.1 (Loranthus grewingkii voucher GUH-3998 tRNA-Leu (trnL) gene, partial sequence; trnL-trnF intergenic spacer, complete sequences; and tRNA-Phe (trnF) gene, partial sequence; chloroplast, 2011); GenBank Accession No. JZ705370.1 (KSU-FB-SSH-ST59 Vicia faba L. cDNA suppression subtractive hybridization library Vicia faba cDNA clone KSU-FB-SSH-ST59, mRNA sequences, 2014); GenBank Accession No. EF590501.1 (Angelica archangelica voucher NMNH 06-8344 ribulose-1,5-bisphosphate carboxylase/oxygenase large subunit (rbcL) gene, partial cds; chloroplast, 2016).
SEQ ID NO: 12 is identical to the reverse complement of GenBank Accession No. DQ500902.1 nucleotides 491-514.
SEQ ID NO: 13 has 96.6% homology to the reverse complement of GenBank Accession No. HQ917115.1 nucleotides 215-239.
SEQ ID NOs: 31 and 33 have the same nucleotide sequence as instant SEQ ID NO: 29, however, SEQ ID NOs: 31 and 33 comprise four or three, respectively, phosphorothioate linkage modifications. SEQ ID NO: 29 is identical to GenBank Accession No. JZ705370.1 nucleotides 45-65. However, the phosphorothioate linkages in SEQ ID NOs: 31 and 33 are not known in the art.
SEQ ID NOs: 32 and 34 have the same nucleotide sequence as instant SEQ ID NO: 30, however, SEQ ID NOs: 32 and 34 comprise four or three, respectively, phosphorothioate linkage modifications. SEQ ID NO: 30 is identical to the reverse complement of GenBank Accession No. EF590501.1 nucleotides 366-351. However, the phosphorothioate linkages in SEQ ID NOs: 32 and 34 are not known in the art.
Thus, there are individual sequences known in the art corresponding to, at least, SEQ ID NOs: 12 and 31-34, and a sequence with a high degree of homology to SEQ ID NO: 13. Generally primer design and optimization is known in the art, as is the modification or primers with phosphorothioate linkages, e.g., to increase specificity. However, the instant primer pairs of SEQ ID NOs: 12-13, and SEQ ID NOs: 31 or 33, and 32 or 34 are not taught in the art. In order to design such pairs, the ordinary artisan would have to know that the corresponding target and non-target sequences have a single nucleotide mismatch at a particular position, and then design the primer pair so that 3’ terminal end of one primer is complementary to one of the mismatched nucleotides, while the 3’ terminal end of the other primer is complementary to the other mismatched nucleotide. Since the art does not teach sequences or alignments showing such mismatches in the target and/or non-target species, there does not appear to be any motivation for ordinary artisan to design these particular primer pairs. Thus, the primer pairs recited in claims 11 and 23 are free of the art.
Allowable Subject Matter
Claims 11-18 are allowed.
Conclusion
Claims 11-21 and 23-33 are being examined. Claims 19-21, 26-28 and 30 are rejected. Claims 23-33 are objected to. Claims 11-18 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 CAROLYN GREENE whose telephone number is (571)272-3240. The examiner can normally be reached M-Th 7:30-5:30 EST.
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/CAROLYN L GREENE/Primary Examiner, Art Unit 1681
1 These references were cited in the PTO-892 Notice of References Cited ailed November 20, 2025.
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