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
1. Applicant’s election without traverse of group I in the reply filed on October 22, 2025 is acknowledged.
Status of the Application
2. Claims 1-16 are considered for examination. Claims 17-20 are withdrawn from further consideration as being drawn to nonelected group.
Priority
3. This application filed on November 14, 2022 is a CON of PCT/US 2021/032404 filed on May 14, 2021 which claims priority benefit of US 63/086,956 filed on October 02, 2020 and US 63/025,420 filed on May 15, 2020.
Specification
4. The disclosure is objected to because of the following informalities:
(i) The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (para 0109, 0116, 0121, 0151). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
(ii) The use of the term (fluorescent label- FAM, HEX, SUN, ROX) in para 0025, 0079, 0082, 0172, 0175-0178, 0191), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. The trademarks are not followed by generic names. Appropriate correction is required.
Claim Rejections - 35 USC § 112
5. 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 14 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 14 contains the trademark/trade name (FAM, SUN, HEX, ROX). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe source of the product and, accordingly, the identification/description of the product is indefinite.
Claim Rejections - 35 USC § 102
6. 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.
Claims 1 and 3-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ngo et al. (Scientific Reports, Vol. 8, 4075, p. 1-13, (2018)).
Ngo et al. teach a method of claim 1, detecting a nucleic acid in a single reaction chamber, comprising: (a) obtaining a patient specimen suspected of comprising a first nucleic acid (page 11, paragraphs under nucleic acid detection in blood lysate section, indicating blood sample from malaria infected malaria-infected cells ); (b) forming a crude lysate from the patient specimen (page 11, paragraphs under nucleic acid detection in blood lysate section); (c) forming a reaction mixture by combining the crude lysate with an infrared-absorbing material, a detecting nucleic acid, and at least one reporter molecule in the single reaction chamber (page 11, paragraphs under nucleic acid detection in blood lysate section: indicating reporter probe functionalized nanorattles (goldNP@cage cube disclosed on page 9-10, paragraphs under materials and methods section); (d) heating the reaction mixture to at least 35°C by irradiating the reaction mixture with infrared light (page 11, paragraphs under nucleic acid detection in blood lysate section: indicating hybridization temperature 40 C); and (e) detecting a presence of the at least one reporter molecule, wherein the presence of the at least one reporter molecule indicates the patient specimen contains the first nucleic acid, and wherein steps (b) through (d) occur in the single reaction chamber (page 11, paragraphs under ‘nucleic acid detection in blood lysate section’).
With reference to claim 3, Ngo et al. teach that the infrared-absorbing material comprises gold nanoparticles (page 9-10, paragraphs under materials and methods section).
With reference to claim 4, Ngo et al. teach that the first nucleic acid is amplified using isothermal amplification (page 11, paragraphs under ‘nucleic acid detection in blood lysate section’). For all the above the claims are anticipated.
Claim Rejections - 35 USC § 103
7. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A. Claims 1 and 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Ngo et al. (Scientific Reports, Vol. 8, 4075, p. 1-13, (2018)) in view of Ying et al. (WO 2018/132062).
Ngo et al. teach a method for a nucleic acid in a sample as discussed above in section 6. However, Ngo et al. did not teach isothermal amplification is a loop-mediated isothermal amplification.
Ying et al. teach a method for detecting target nucleic acid in a sample using gold nanoparticles, labeled oligonucleotides (page, wherein the method comprises amplification of a target nucleic acid in a loop mediated isothermal amplification (page 17, line 17 to line 32 on page 18).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the invention to combine the method of Ngo et al.
with the loop mediated isothermal amplification (LAMP) as taught by Ying et al. to develop an improved method for detecting a target nucleic acid. The ordinary person skilled in the art would have motivated to combine the method as taught by Ngo et al. with LAMP as taught by Ying et al. and have a reasonable expectation of success that the combination would result in rapid method for detecting a target nucleic acid because Ying et al. explicitly taught use of LAMP for detecting a target nucleic acid in a sample which improves the efficiency and requires shorter time to complete (page 18, line 1-6) and such a modification of the method is considered obvious over the prior art.
B. Claims 1-4 and 6-16 are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg et al. (US 2006/0166249) in view of Ngo et al. (Scientific Reports, Vol. 8, 4075, p. 1-13, (2018)).
Rothberg et al. teach a method of claim 1, 3, detecting a nucleic acid in a single reaction chamber, comprising: (a) and (b) obtaining sample that includes patient sample suspected of comprising a first nucleic acid (para 0014-0016, 0102, 0152, 0157 indicating use of a patient or clinical sample); (c) forming a reaction mixture by combining the sample with an infrared-absorbing material (gold nanoparticles), a detecting nucleic acid, and at least one reporter molecule in the single reaction chamber (0010-0016, 0034, 0191-0195); (d) heating the reaction mixture to at least 35°C by irradiating the reaction mixture with infrared light (temperature increase or heating) (para 0012, 0034, 0191-0195); and (e) detecting a presence of the at least one reporter molecule, wherein the presence of the at least one reporter molecule indicates the patient specimen contains the first nucleic acid, and wherein steps (b) through (d) occur in the single reaction chamber (0012, 0034, 0191-0195, 0010-0016).
With reference to claim 2, Rothberg et al. teach that the at least one reporter molecule comprises at least two reporter molecules (FRET labels) (para 0053-0054).
With reference to claim 4, 6-10, Rothberg et al. teach that the first nucleic acid is amplified using one of polymerase chain reaction (PCR), wherein the heating of the reaction mixture denatures the first nucleic acid at a denaturing temperature , adding nucleotides to the reaction mixture, and allowing extension of the annealed nucleic acid with the nucleotides and the method further comprising cooling the reaction mixture to an annealing temperature after step (d), and allowing the detecting nucleic acid to anneal to the first nucleic acid, forming an annealed nucleic acid, wherein a temperature within the reaction chamber cycles between a denaturing temperature and an annealing temperature at least 10 times) wherein the first nucleic acid is ribonucleic acid (RNA), further comprising reverse transcribing the RNA prior to the heating of the reaction mixture (para 0191-0195).
With reference to claim 11, Rothberg et al. teach that a method for detecting a presence or absence of a plurality of different molecules (fluorescent labels) within a reaction container comprising: (a) illuminating contents of the reaction container using infrared light until a temperature within the reaction container reaches a denaturing temperature (para 0187-0195, 0034-0036, ); (b) allowing the heated contents of the reaction container to cool until a temperature within the reaction container reaches an annealing temperature (para 0194, 0034-0036, 0191-0195); (c) and (d) illuminating the contents of the reaction container with excitation light and obtaining, while the contents of the reaction container are being illuminated with the excitation light, a respective measured spectrum of light that is being emitted by the contents of the reaction container (para 0191-0195, 0034-0036); (e) deconvolving the respective measured spectrum into a plurality of respective individual spectra, each of which corresponds to a respective one of the different molecules (para 0034-0036,0053-0054, 0191-0195); (f) outputting data corresponding to each of the respective individual spectra; and (g) repeating steps (a) through (f) at least 10 times (para 0191-0195, 0151, 0034-0036, 0054-0059).
With reference to claim 12-13, Rothberg et al. teach that the step (g) comprises repeating steps (a) through (f) at least 40 times and wherein the plurality of different molecules comprises at least three different molecules (para 0195).
With reference to claim 14, Rothberg et al. teach that the plurality of different molecules comprises at least two molecules selected from the group consisting of FAM, SUN, HEX, and ROX (para 0053-0054).
With reference to claim 15, Rothberg et al. teach that each of the plurality of different molecules comprises a fluorescent dye having an excitation wavelength between 480 and 600 nm and an emission wavelength between 500 and 625 nm (para 0059).
With reference to claim 16, Rothberg et al. teach that the reaction container contains gold nanoparticles dispersed in a liquid (para 0010-0012, 0034).
However, Rothberg et al. did not teach use of cell lysate.
Ngo et al. teach a method of detecting a nucleic acid in a single reaction chamber, comprising: (a) obtaining a patient specimen suspected of comprising a first nucleic acid (page 11, paragraphs under nucleic acid detection in blood lysate section, indicating blood sample from malaria infected malaria-infected cells ); (b) forming a crude lysate from the patient specimen (page 11, paragraphs under nucleic acid detection in blood lysate section); (c) forming a reaction mixture by combining the crude lysate with an infrared-absorbing material, a detecting nucleic acid, and at least one reporter molecule in the single reaction chamber (page 11, paragraphs under nucleic acid detection in blood lysate section: indicating reporter probe functionalized nanorattles (goldNP@cage cube disclosed on page 9-10, paragraphs under materials and methods section).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the invention to combine the method of Rothberg et al.
with the cell lysate as taught by Ngo et al. to develop an improved method for detecting a target nucleic acid. The ordinary person skilled in the art would have motivated to combine the method as taught by Rothberg et al. with the cell lysate as taught by Ngo et al. and have a reasonable expectation of success that the combination would result in improved method for detecting a target nucleic acid because Ngo et al. explicitly taught use of cell lysate without purification for direct detection of a target nucleic acid in a sample (page 1, abstract) and such a modification of the method is considered obvious over the
prior art.
Conclusion
No claims are allowable.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681