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
Status of the Claims
Claims 1-4, 10-15, 18, 20-22, 24-27, 30-31 and 33-35 are pending. Claims 1-4, 11, 15, 20-22, 24-26 and 34 are the subject of this NON-FINAL Office Action. Claims 10, 12-14, 18, 27, 30-31 and 35 are withdrawn. This is the first action on the merits.
Election/Restrictions
Applicant’s election without traverse of Group 1 and the species of (1) nanopore sequencing (2) helicase motor protein, (3) single-stranded polynucleotide blocker, (4) loading site for blocking and (5) claim 11 in the reply filed on 08/22/2025 is acknowledged. The elections read on claims 1-4, 11, 15, 20-22, 24-26 and 34.
Claims 10, 12-14, 18, 27, 30-31 and 35 are withdrawn.
Claim Rejections - 35 USC § 112- Indefiniteness
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.
Claims 1-4, 11, 15, 20-22, 24-26 and 34 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 pre-AIA the applicant regards as the invention.
As to claims 1-4, they are utterly confusing in light of claim 11, which reflects the election of species. Specifically, the following two statements are mutually exclusive: “wherein the blocking moiety prevents the motor protein from moving off the spacer” (claims 1-4); versus “wherein binding the blocking moiety to the polynucleotide adapter forces the motor protein onto the spacer.” In other words, claims 1-4 require a step of “positioning the motor protein on the spacer” before binding the blocking moiety so that the blocking moiety cannot force the motor protein onto the spacer. Applicants must amend the claims to remove this confusing conflict.
Claim 4 is confusing because it recites “a motor protein,” but claim 3 already recites “a motor protein.” Is this a different motor protein?
Claims 20-21 confusingly include a “non-hybridised polynucleotide” that binds to the loading site. How can a non-hybridized polynucleotide be hybridized? In addition, if this is a blocking moiety, how does it block the motor protein if it is not hybridized to the adaptor? In fact, claims 1 and 3 require the blocking moiety is bound to the adaptor. This is mutually exclusive of non-hybridized.
Claim 22 is an utterly improper Markush Grouping as is evident on its face. See MPEP §§ 2117 & 2173.05(h).
Claim 24 recites “preferably,” which is confusing. See MPEP § 2173.05(d).
Claim 25 is an improper Markush group missing the proper transitional phrasing. See MPEP §§ 2117 & 2173.05(h).
Claim 25 is also confusing because its states “wherein the spacer comprises [various versions of -S-N-] wherein each S is a spacer unit and each N is a nucleotide.” It is unclear how a spacer comprises itself.
In claim 26, it is not clear what Applicants mean by “independently selected.” For example, independent of what?
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 11, 15, 20-22, 24-26 and 34 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by RAND (US 20180030525).
As to claims 1-3 and 26, RAND teaches providing adaptor 304-306 with spacer 306 (Fig. 3); contacting adaptor 304-306 with helicase 308 (Fig. 3); the helicase 308 positioned on the spacer 306 (Fig. 3); and blocking moiety 304 bound to adaptor (Fig. 3; para. 0062).
As to claims 4 and 11, the blocking moiety 304 is bound to a loading site and prevents helicase from proceeding to loading site (Fig. 3; paras. 0059 & 0061-62).
As to claims 15, 20-21, the loading moiety includes single strand as does blocking moiety (id.)
As to claims 22 and 24-25, the spacer 306 includes nucleotides (para. 0015).
As to claim 34, taking one or more measurements as the target polynucleotide moves with respect to the nanopore, wherein the one or more measurements are indicative of one or more characteristics of the target polynucleotide, and thereby characterising the target polynucleotide as it moves with respect to the nanopore (e.g. Abstract and Figs. 1 & 4).
Prior Art
The following prior art also teaches nanopore systems with blocking moiety on adaptor for helicase-based movement: US 20130327644 (Fig. 4); US20160010147; US 20170306398; US 20170240955; US 20170253910; US 20170253923; US 20190071721; US 20190194722; US 20200024654; US 20190004029; US11560589; US 10059988; US 20100035260; US 20150152495; US20220042967.
Conclusion
No claims are allowed.
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/AARON A PRIEST/Primary Examiner, Art Unit 1681