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. The Applicant’s response to the office action filed on May 14, 2026 is acknowledged.
Status of the Application
2. Claims 1-16 are pending under examination. Claims 17-20 are previously withdrawn from further consideration as being drawn to nonelected group. The Applicant’s arguments and the amendment have been fully considered and found persuasive in-part for the following reasons.
Objection to the Specification-Maintained
3. The disclosure is objected to because of the following informalities:
(i) 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.
Response to Arguments:
(i) the objection to the trademarks has been maintained because the amendment did not provide generic names for the fluorescent dyes.
(ii) The objection to the embedded hyperlink has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 112-Maintained
4. 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.
Response to Arguments:
With reference to the rejection of claims under 35 USC 112(b), the Applicant’s arguments and the amendment have been fully considered and found unpersuasive. As discussed in the rejection the trademarks in claims represent the source of the products, but not the product itself. The use of trademarks in claims is indefinite and unclear because it is not clear if the trademarks represent the source of the product or the product. The rejection is maintained and restated.
Claim Rejections - 35 USC § 102-Withdrawn
5. The rejection of claims under 35 USC 102(a)(1) as being anticipated by Ngo et al. has been withdrawn in view of the persuasive arguments.
Claim Rejections - 35 USC § 103-Withdrawn
6. The rejection of claims under 35 USC 103 as being obvious over Ngo et al. in view of Ying et al. and the rejection of claims under 35 USC 103 as being obvious over Rothberg et al. in view of Ngo et al. have been withdrawn in view of the persuasive arguments.
New Rejections
Claim Rejections - 35 USC § 102
7. 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.
A. Claims 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (Optics Express, Vol. 17(1), page 218-227, (2009)).
Kim et al. teach that a method of claim 11, for detecting a presence or absence of a plurality of different molecules (fluorescent molecules) 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 (page 221-227, paragraphs under sections 2.1-3.2); (b) allowing the heated contents of the reaction container to cool until a temperature within the reaction container reaches an annealing temperature (page 221-227, paragraphs under sections 2.4-3.2); (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 (page 221-227,, paragraphs under sections 2.4-3.2); (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 (page 221-227,, paragraphs under sections 2.4-3.2); (f) outputting data corresponding to each of the respective individual spectra; and (g) repeating steps (a) through (f) at least 10 times (page 221-227,, paragraphs under sections 2.4-3.2).
With reference to claim 12-13, Kim 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 (page 221-222, paragraphs under sections 2.4).
With reference to claim 14, Kim 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 (page 221-222, paragraphs under sections 2.4).
With reference to claim 15, Kim 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 (page 221-222, paragraphs under sections 2.4). For all the above the claims are anticipated.
B. Claims 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brennan et al. (Sensors and Actuators B 239, page 235-242, (2017)).
Brennan et al. teach that a method of claim 11, for detecting a presence or absence of a plurality of different molecules (molecular beacons comprising fluorescent molecules) 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 (page 236-237, paragraphs under section 2.5-2.8); (b) allowing the heated contents of the reaction container to cool until a temperature within the reaction container reaches an annealing temperature (page 236-237, paragraphs under section 2.5-2.8); (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 (page 236-237, paragraphs under section 2.5-2.8); (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 (page 236-237, paragraphs under section 2.5-2.8); (f) outputting data corresponding to each of the respective individual spectra; and (g) repeating steps (a) through (f) at least 10 times (page 236-240, paragraphs under section 2.5-3.4).
With reference to claim 12-13, Brennan 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 (page 236, paragraphs under section 2.5).
With reference to claim 14, Brennan 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 (page 237, paragraphs under section 2.8, page 240, paragraphs 1-2 under discussion section).
With reference to claim 15, Brennan 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 (page 237, paragraphs under section 2.8). For all the claims are anticipated.
Claim Rejections - 35 USC § 103
8. 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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Brennan et al. (Sensors and Actuators B 239, page 235-242, (2017)) in view of Harwood et al. (US 2016/0199853).
Brennan 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 236, paragraphs under section 2.1and 2.5);
(c) forming a reaction mixture by combining the sample with an infrared-absorbing material (magnets), a detecting nucleic acid (sample comprising a target nucleic acid), and at least one reporter molecule (molecular beacon probes comprising reporter molecules) in the single reaction chamber (page 236-240, paragraphs under section 2.5-3.4); (d) heating the reaction mixture to at least 35°C by irradiating the reaction mixture with infrared light (page 236-240, paragraphs under section 2.5-3.4); 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 236-240, paragraphs under section 2.5-3.4).
With reference to claim 2, Brennan et al. teach that the at least one reporter molecule comprises at least two reporter molecules (page 236-0240, paragraphs under section 2.5-3.4).
With reference to claim 4, Brennan et al. teach that the first nucleic acid is amplified using isothermal amplification (page 236, paragraphs under section 2.5).
With reference to claims 6-10, Brennan et al. teach that the first nucleic acid is amplified using isothermal amplification, 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) (page 236-0240, paragraphs under section 2.5-3.4).
However, Brennan et al. did not teach use of cell lysate.
Harwood et al. teach a method for detecting a target nucleic acid in a device comprising cell capture, cell lysis followed by Infrared light thermal controlled cycling, wherein the device is coated by light absorbing gold material (para 0152-0155, 0193-0194, 0227-0240). Harwood et al. also teach that the method further comprises reverse transcribing the RNA prior to the heating the reaction mixture and the amplification comprises loop-mediated isothermal amplification (para 0146).
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 Brennan et al. with the cell lysate as taught by Harwood 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 Brennan et al. with the cell lysate as taught by Harwood et al. and have a reasonable expectation of success that the combination would result in improved method for detecting a target nucleic acid because Harwood et al. explicitly taught use of cell lysate without purification for direct detection of a target nucleic acid in a sample (para 0152-0155) and such a modification of the method is considered obvious over the prior art. Further, it would be obvious to modify the method with RT-LAMP as taught by Harwood et al. to improve the method for detecting target RNA in a sample.
B. Claims 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Brennan et al. (Sensors and Actuators B 239, page 235-242, (2017)) in view of Harwood et al. (US 2016/0199853).
Brennan et al. teach a method for detecting plurality of different molecules as discussed above in 7B. However, Brennan et al. did not specifically teach gold particles.
Harwood et al. teach a method for detecting a target nucleic acid in a device comprising cell capture, cell lysis followed by Infrared light thermal controlled cycling, wherein the device is coated by light absorbing gold nanoparticle material (para 0152-0155, 0193-0194, 0227-0240).
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 Brennan et al. with the gold nanoparticles as taught by Harwood 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 Brennan et al. with gold nanoparticles as taught by Harwood et al. and have a reasonable expectation of success that the combination would result in improved method for detecting a target nucleic acid because Harwood et al. explicitly taught use gold particle material, which absorbs infrared light (para 0152-0155) and such a modification of the method is considered obvious over the prior art.
C. Claims 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (Optics Express, Vol. 17(1), page 218-227, (2009)) in view of Harwood et al. (US 2016/0199853).
Kim et al. teach a method for detecting plurality of different molecules as discussed above in 7A. However, Kim et al. did not specifically teach gold nanoparticles.
Harwood et al. teach a method for detecting a target nucleic acid in a device comprising cell capture, cell lysis followed by Infrared light thermal controlled cycling, wherein the device is coated by light absorbing gold nanoparticle material (para 0152-0155, 0193-0194, 0227-0240).
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 Kim et al. with gold nanoparticles as taught by Harwood 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 Kim et al. with gold nanoparticles as taught by Harwood et al. and have a reasonable expectation of success that the combination would result in improved method for detecting a target nucleic acid because Harwood et al. explicitly taught use gold particle material, which absorbs infrared light (para 0152-0155) 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
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