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 invention I and the required species in the reply filed on 8/18/2023 and 4/18/2024 is acknowledged.
Claims 13-19 and 21 are drawn to non-elected species and therefore are withdrawn.
Claims 1, 3-8, 11-12, 20, 22 and 23 are examined on the merits.
Prior Claim Objections-withdrawn in lieu of claim amendments
Claim Objections
(New Objection) Claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
(Prior Rejection Withdrawn in response to claim amendments) Claim 23 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to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.
(New Rejection Necessitated by Amendments) Claims 3, 4 and 22 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. Claims 3, 4, and 22 depend from cancelled claim 2, therefore, it is unclear which claims the limitations of 3, 4 and 22 are attempting to further limit.
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.
(New Rejection Necessitated by Amendments) Claims 3, 4 and 22 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. Claims 3, 4, and 22 depend from claim 2, but claim 2 has been cancelled by applicant. Therefore, claims 3, 4 and 22 do not further limit claim 2. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 –
(a)(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.
(Prior Rejection Maintained and extended to claim 23 due to amendments) Claim(s) 1, 5, 7, 8, 11, 12, 20-21 and 23 are rejected under 35 U.S.C. 102a1 as being anticipated by Mir (US PGPub 2005/0244863).
The claimed invention is drawn to an in-vitro method for detecting one or more copies of a target nucleic acid in a sample, comprising:
a) contacting the sample with a probe wherein the probe is labeled with a fluorescent dye and adapted to hybridize with the target nucleic acid;
b) irradiating the probe with an excitation light to excite the fluorescent dye;
c) observing, with a detector, for an emission of light from the fluorescent dye; and
d) determining if the target nucleic acid is in the sample based on a detection of light of a predefine peak (wavelength) emitted by the fluorescent dye;
wherein the probe is immobilized to a carrier element (a liquid swelling polymer) prior to contact with the sample, and an optical element is positioned proximate to the carrier element and adapted to permit light emitted from fluorescent dye to pass therethrough to the detector;
wherein the light emitted by the fluorescent dye is sufficient to record fluorescent spectra of the fluorescent dye attached to the nucleic acid; and
wherein the method allows a detection of each single hybrid between the probe and the target and a determination of hybridization events between the probe and the target to detect at least one target nucleic acid and probe hybrid molecule in the sample without amplification of the nucleic acids in the sample.
The excitation light is a laser beam.
The method also requires an analyzing unit for detecting that involves a light source configured to emit excitation light to carrier, a detector for receiving light emitted from a carrier element and a microprocessor that received data from the detector in order to determine if the target nucleic acid is present. The method also requires the use of a beam splitter for high pass optical filter, the detector is configured to receive light through an optical element of an optical fiber, and the focusing of an element configured to delivery excitation light from light source to a carrier element. The method further requires that at least one beam collimating element configured to collect light emitted from a carrier element.
The probe is a molecular beacon.
Mir teach the development of a nucleic acid detection method that utilizes probes for detecting individual (single) nucleic sequences present in a sample, which would be able to detect less than 10 target nucleic acids. [see paragraphs 87-93, 316-319, 322, 325, and 425] The detection method does not rely on amplification. The probes can be a molecular beacon and the solid support can be a polymer, such as a gel, which is inherently a liquid swelling polymer. [see paragraph 74] The detection can take place with the probe immobilized on a solid support and the probe hybridizes with complementary nucleic acid sequences present in the sample. The amount of probe or oligonucleotide to be used can be at a concentration of 5-10 pmol. [see paragraph 782] Laser beams can be used to excite a fluorescent dye on the probe and the detection would involve a light source, detector and computer/microprocessor that is configured to receive information from the detector to determine if the amount of light is indicative of a hybridization event. [see paragraphs 225, 328, 330, and 1021] Mir also teach that a beam splitting apparatus can be employed [see paragraph 1039] and light detected through a fiber optic can be employed. [see paragraphs 75, 93, 203 and 276] The method would employ an element capable of focusing light towards the solid support (carrier element) and a beam for collecting light from a carrier element and the use of glass slides or coverslips in facilitating fluorescence signal transmission. [see paragraphs 337, 347-351, 353, 1020-1023 and 1042]
Therefore, Mir anticipate the instant invention.
Response to arguments:
Applicant’s arguments have been fully considered, but they are not persuasive for the following reasons:
Presently the claimed invention rejected requires the use of a liquid swelling polymer for immobilizing a probe that is used to detect nucleic acid sequences. Mir et al. teach that a gel can be use used as a solid support and that probes can be immobilized on solid supports. [see paragraphs 74 and 425] While applicants state that their polymer would have a benefit as being able to fit more probe on the 3 dimensional surface, the claims do not require that the polymer is 3 dimensional (such as a particle). Furthermore, since claim 2 was cancelled and its dependent claims were not amended to depend from claim 1, the claim limitations of probe concentrations on the carrier element are not part of the rejected invention (see 35 USC 112b/d rejections above). Lastly, any unexpected benefits or properties of using the claimed polymer are not persuasive since this is an anticipatory rejection and not an obviousness type rejection.
Conclusion
No claims 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 BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671