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 .
Election/Restrictions
Applicant’s election without traverse of species HIV associated antigen and a nanopore of less than 5nm in diameter in the reply filed on 3/30/2026 is acknowledged.
Specification
The disclosure is objected to because of the following informalities: Pages 8 and 16 contain nucleotide sequences without the appropriate sequence identifier (e.g., SEQ ID NO: X). Further, there is no sequence listing in paper or computer readable form.
Additionally, there is no description provided for Figure 4H, and Figure 27A should be amended to recite Figure 27 as there is no Figure 27A.
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 1-3 and 6-14 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.
The instant claims are directed to method of detecting an antigen, the method comprising:
a. providing a sample comprising the antigen;
b. incubating the sample with a capture antibody-modified bead and a detection antibody-modified copper-based nanoparticle to form a sandwich structure complex;
c. separating the sandwich structure complex from the sample;
d. releasing copper ions from the separated sandwich structure complex in an acidic environment;
e. coupling a modified nucleic acid molecule and a second molecule comprising an azido functional group in the presence of the copper ions to form a polynucleotide complex, wherein the modified nucleic acid molecule is coupled to the azido functional group via a click reaction;
f. non-covalently bonding a probe to the polynucleotide complex to form a polynucleotide probe;
g. loading the polynucleotide-probe into a nanopore;
h. applying an electrical potential across said nanopore to induce translocation of the polynucleotide-probe through said nanopore; and
i. detecting an electrical signal associated with the translocation of said polynucleotide-probe through the nanopore;
wherein a characteristic of the signal is indicative of the presence or concentration of the antigen in the sample.
Regarding step (e), there is no written support that any known modified nucleic acid (e.g., a sugar modified nucleic acid, a based modified nucleic acid, or a backbone modified nucleic acid) may be used in the “click reaction”. The specification teaches that a an alkyne modified nucleic acid is paired with the molecule comprising an azido function group. There is no teaching that any other modified nucleic acids can be used with the molecule comprising an azido function group.
Regarding step (f), there is no written support that any known type of probe can be used along with the nanopore. The specification teaches that the probe can be cucurbit[7]uril hydrate (CB[7]), cucurbit[6]uril hydrate (CB[6]), cyclodextrins or a combination thereof. There is no teaching of other structures that can be used as a probe for the recited nanopore. There is also no written description that any known probe can work with any known nanopore. According to the specification, cucurbit[7]uril hydrate (CB[7]), cucurbit[6]uril hydrate (CB[6]), and cyclodextrins work with the α-hemolysin nanopore. There is no teaching/description in the specification for pairing a particular probe with a particular nanopore. Additionally, there is no written description for non-covalently bonding the probe to any position on the nucleic acid. According to Figure 1, the probe is bonded only to the azido group of the polynucleotide complex.
Accordingly, the full breadth of the claims does not meet the written description provision of 35 U.S.C. 112, first paragraph.
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 12 and 13 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 12 recites the limitation "wherein (d) further comprises: inserting the nanopore into a phosphate lipid bilayer . . . ". There is insufficient antecedent basis for this limitation in the claim. Claim 1, part (d) does not recite a nanopore.
Claim 13 recites the limitation "wherein (e) further comprises: applying an external positive voltage to a trans facing side of the bilayer . . . ". There is insufficient antecedent basis for this limitation in the claim. Claim 1, part (e) does not recite a bilayer.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole Kinsey White whose telephone number is (571)272-9943. The examiner can normally be reached M to Th 6:30 am to 6:00 pm.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
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