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 .
Priority
This application is a 371 of PCT/US2020/29199 filed on 04/22/2020 which claims benefit of U.S. Serial Application 62/839,845 filed on 04/29/2019.
Status of the Applications, Amendments and/or Claims
This action is written in response to applicant's correspondence(s) submitted on 03/21/2025. In the paper of 03/21/2025, Applicant amended claims 1, 6, 8-9, 11-14, 17 and canceled claims 2-5, 7, 10, 15-16, 18-24 and added new claims 26-41. Accordingly, claims 1, 6, 8-9, 11-14, 17, 26-41 are pending and under review.
Election/Restrictions
Applicant’s election without traverse of the following species in the reply filed on 03/21/2025 is acknowledged.
Concerning species group A: Set-up for identifying at least one nucleic acid, Applicant elects:
Having at least one camera filter positionable to filter light entering the camera (claim 1).
Concerning species group B: Type of nucleic acid to be detected, Applicant elects:
Both DNA or RNA (claim 1).
Concerning species group C: Specific step(s) to be repeated, Applicant elects:
step (g) is repeated at least one time (claim 2).
Concerning species group D: Defined flow path type, Applicant elects:
a curved segment.
Concerning species group E: Source of nucleic acid for identification, Applicant elects:
bacterial (claims 14-15).
Status of the claims
Claims 1, 6, 8-9, 11-14, 17 and 26-41 are pending and under review.
Claim Objections
Claim 29 is objected to because of the following informalities: Claim 29 recites the limitation “wherein the step of controlling the temperature controls the temperature of the first fluid and the second fluid by cycling the temperature of the first fluid”. This limitation contains spelling and/or grammatical errors. The amendment of this limitation to “controlling the temperature of the first and second fluids comprises cycling the temperature of the first fluid”, is suggested to maintain claim clarity. Appropriate correction is required.
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.
Claims 6 and 8-9 and 40 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 6 and 40 each recites the limitations “one of fluorescent intensity, size and position” which are found lacking in clarity since it is unclear whether the limitations are directed to fluid property being fluorescent intensity, fluorescent size or fluorescent position; or whether the limitations are directed to fluid property being directed to fluorescent intensity, fluid size and fluid position. Amendment is required.
Claims 8-9 recite the limitations “the sequence of steps”. There is no antecedent basis for this limitation “the sequence” in the claim. Furthermore, it is unclear of whether claims 8-9 is simply requiring the method of claim 1, further comprising repeating step (c) and step (d) for at least 10 times or up to 40 times.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 6, 8-9, 11-14, 17 and 26-41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zec et al. (Epub March 26, 2018, Nanoengineering, 4(1)17097, pp.1-10).
Regarding claim 1, Zec et al. teach a continuous flow PCR method for identifying at least one nucleic acid in a sample (see abstract, wherein Zec et al discloses a droplet based genotyping method for genotyping maize genomic DNA utilizing a microfluidic device comprising nano sample processors).
The method of Zec et al. comprises:
(a) providing a flow path (see abstract and see the continuous droplet flow pathway as illustrated in pg 2, Fig. 1a; and see pg 2, left col., 2nd para: and pg 2, right col., 1st para, wherein Zec et al teach two inlets provided on the nano sample processors which are used to sequentially load samples into a microfluidic device and within the device, each sample is digitized into droplets and each sample droplet is directly injected, without the need of droplet synchronization, into a corresponding SNP-interrogating reagent/probe based on the isothermal and robust Invader assay chemistry. Zec et al. discloses that multiple DNA sample droplets are being generated and sequentially injected with reagents/probes and further downstream, DNA–probe droplets are simultaneously incubated to carry out the Invader reaction and detected for an in-line fluorescence read-out, Zec et al. discloses sequence of individual droplets is maintained as it flows throughout the device, allowing for accurate droplet identification by spatial indexing);
a camera positioned to image the flow path (see pg 2, Fig. 1a, portion of the illustration depicted as in-line detection for assay read-out),
an illumination source positioned to illuminate the flow path (see pg 2, Fig. 1a, portion of illustration depicted as in-line detection for assay read-out; see also pg 3, Fig. 2b, CCD camera illustrated),
a memory, and a processor, wherein the processor is in operable connectivity with the camera, the illumination source and the memory (pg 3, see Fig. 2b which shows CCD connected with detection optics);
(b) introducing the sample to the flow path in a first fluid and in a second fluid, wherein the first fluid further comprises first reagents comprising at least one fluorescent compound, and wherein the second fluid further comprises second reagents comprising at least one fluorescent compound and wherein the first fluid and the second fluid are separated by a third fluid;
(c) imaging the flow path by illuminating the flow path using the illumination source and capturing at least one image of the flow path using the camera to create an image set (see pg 3, Fig. 2b, wherein Zec et al. teach LED to illuminate the microfluidic device and see illustrations for CCD and Detection optics in Fig. 2b, these elements are for capturing signals from flow path);
(d) registering the first fluid and the second fluid across the image sets, the image set having at least two images, by determining at least one property of the first fluid and identifying the first fluid across the at least two images of the image set based on the at least one property of the first fluid and determining at least one property of the second fluid and identifying the second fluid across the at least two images of the image set based on the at least one property of the second fluid (pg 8, Fig. 5); and
(e) identifying the at least one nucleic acid in the sample (pg 8, left col., 1st and 2nd para below Fig. 5 and all text of right col., and all text of pg 9).
Regarding claim 6, Zec et al. teach wherein the at least one property of the first fluid of step (d) is at least one of fluorescent intensity, size and position and the at least one property of the second fluid of step d is at least one of fluorescent intensity, size and position (pg 7, section entitled “Fluorescence detection of invader products in droplets”).
Regarding claim 8, Zec et al. teach the sequence of steps (c) and (d) is repeated 10 to 40 times (pg 2, right col., Materials and Methods, “Multiplexed PCR”).
Regarding claim 9, Zec et al. teach the sequence of steps (c) and (d) is repeated 38 to 40 times (pg 2, right col., Materials and Methods, “Multiplexed PCR”).
Regarding claim 11, Zec et al. teach the flow path contains at least one of a linear segment, a curved segment, a spiral segment, and a serpentine segment (pg Fig. 1a, illustrates curved segment or serpentine channels).
Regarding claim 12, Zec et al. teach the first fluid is aqueous, the second fluid is aqueous, and the third fluid is at least one of oil and gas (pg 4, all text of section entitled “On-chip SNP genotyping invader assay(synthetic and genomic targets)”).
Regarding claim 13, Zec et al. teach at least one illumination filter is positionable to filter light exiting the illumination source (pg 3, Fig. 2b).
Regarding claim 14, Zec et al. teach at least one nucleic acid is selected from the group consisting of viruses, bacteria, fungi, animals, insects, plants, and artificial constructs (pg 2, right col., 1st para, SNPs of maize DNA genotyped).
Regarding claim 17, Zec et al. teach at least one nucleic acid is at least one of DNA and RNA (pg 2, right col., 1st para, SNPs of maize DNA genotyped).
Regarding claim 26, Zec et al. teach method of claim 1, further comprising providing a thermal device in thermal connectivity with the flow path (pg 2, right col., Materials and Methods, “Multiplexed PCR” and/or pg 4, all text of section entitled “On-chip SNP genotyping invader assay (synthetic and genomic targets)” and pg 4, right col., section entitled “Fluorescence detection set-up and data analysis” and/or pg 7, right col., section entitled “On-chip genotyping of synthetic DNA samples’).
Regarding claim 27, Zec et al. teach method further comprising controlling the temperature of the first fluid and the second fluid using the thermal device to amplify the at least one nucleic acid in the first fluid and the second fluid by polymerase chain reaction (PCR) (pg 2, Figs. 1a-1b and pg 2, right col., Materials and Methods, “Multiplexed PCR” and pg 3, left col., 1st para and pg 6, right col., section entitled “Benchtop verification of invader assay”).
Regarding claim 28, Zec et al. teach the step of controlling the temperature is repeated at least one time (pg 2, right col., Materials and Methods, “Multiplexed PCR”.
Regarding claim 29, Zec et al. teach controlling the temperature controls by cycling the temperature of the first fluid and the second fluid between a temperature above 75 degrees Celsius and a temperature below 75 degrees Celsius using the thermal device (pg 2, right col., Materials and Methods, “Multiplexed PCR”).
Regarding claim 30, Zec et al. teach further comprising providing at least one camera filter positionable to filter light entering the camera (see optical BP filters and other filters that are illustrated on pg 3, Fig. 2b).
Regarding claim 31, Zec et al. teach the step (c) of imaging the flow path also uses the at least one camera filter (see optical BP filters and other filters that are illustrated on pg 3, Fig. 2b).
Regarding claim 32, Zec et al. teach imaging the flow path comprises illuminating the flow path using the illumination source and capturing at least one background image of the flow path using the camera (pg 8, Fig. 5 and all text of pg 8-9).
Regarding claim 33, Zec et al. teach wherein the step (c) of imaging the flow path further comprises subtracting the at least one background image to create an image set (pg 8, Fig. 5 and all text of pg 8-9).
Regarding claim 34, Zec et al. teach the first reagents further comprise polymerase chain reaction (PCR) reagents (pg 2, right col., Materials and Methods, “Multiplexed PCR”).
Regarding claim 35, Zec et al. teach the second reagents further comprise polymerase chain reaction (PCR) reagents (pg 2, right col., Materials and Methods, “Multiplexed PCR”).
Regarding claim 36, Zec et al. teach computing the movement of the first fluid and the second fluid in the flow path and applying a correction factor for the movement (pg 4, right col., Fluorescence detection set-up and data analysis” and all text and figures of page 5 and pg 8, Fig. 5).
Regarding claim 37, Zec et al. teach associating a fluorescent intensity of the first fluid and the second fluid in the image set with the at least one nucleic acid to create a fluorescent intensity group for the at least one nucleic acid for the first fluid and second fluid (pg 4, right col., Fluorescence detection set-up and data analysis” and all text and figures of page 5 and pg 8, Fig. 5 and all text of pg 8-9).
Regarding claim 38, Zec et al. teach computing at least one curve property of the fluorescent intensity group for the at least one nucleic acid (pg 4, right col., Fluorescence detection set-up and data analysis” and all text and figures of page 5 and pg 8, Fig. 5 and all text of pg 8-9).
Regarding claim 39, Zec et al. teach comparing the at least one curve property to a library of the at least one curve property of known nucleic acids (pg 4, right col., Fluorescence detection set-up and data analysis” and all text and figures of page 5 and pg 8, Fig. 5 and all text of pg 8-9).
Regarding claim 40, Zec et al. teach associating the fluorescent intensity associates the fluorescent intensity of the first fluid in the image set with the at least one nucleic acid by using at least one of the size, fluorescent intensity, and position of the first fluid and the fluorescent intensity of the second fluid in the image set with the at least one nucleic acid by using at least one of the size, fluorescent intensity, and position of the second fluid (pg 4, right col., Fluorescence detection set-up and data analysis” and all text and figures of page 5 and pg 8, Fig. 5 and all text of pg 8-9).
Regarding claim 41, Zec et al. teach at least one curve property of the fluorescent intensity group of the step of computing the at least one curve property is at least one of crossing threshold (Ct) and relative fluorescent units (RFU) (pg 4, right col., Fluorescence detection set-up and data analysis” and all text and figures of page 5 and pg 8, Fig. 5 and all text of pg 8-9).
Accordingly, the instant claims 1, 6, 8-9, 11-14, 17 and 26-41 are anticipated by Zec et al.
Conclusion
No claims are currently allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLAYINKA A OYEYEMI whose telephone number is (571)270-5956. The examiner can normally be reached Monday -Thursday: 9:00 am - 5:00 pm, EST.
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OLAYINKA A. OYEYEMI
Examiner
Art Unit 1681
/OLAYINKA A OYEYEMI/Examiner, Art Unit 1681
/GARY BENZION/Supervisory Patent Examiner, Art Unit 1681