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 .
Claim Objections
Claim 31 is objected to because of the following informalities: in line 6, the term “configured” should be inserted prior to the term “for” to positively recite the functionality of the one or more locations. Appropriate correction is required.
Note Regarding Prior Art
Examiner cites particular sections, columns, line numbers, paragraphs and figures, in the references as applied to the claims below for the convenience of the Applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the Applicant fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 – 8, 11 – 14, 21 – 28, 30 and 31 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Huff et al. (US 11,016,053 B2; hereinafter “Huff”).
Regarding claim 1, Huff teaches throughout the publication a method for analyzing a droplet on a surface of a cartridge, wherein the droplet comprises a plurality of particles (col. 19, lines 42 – 49), the method comprising:
transporting, via a plurality of electrodes of the cartridge, the droplet along a single path on the surface of the cartridge, wherein the single path is substantially linear and the plurality of electrodes is configured to transport the droplet along the single path on the surface of the cartridge (col. 73, lines 21 – 32; col. 74, lines 59 – 64; col 96, line 34 – col. 97, line 7; col. 98, lines 19 – 25; col. 105, lines 18 – 21; col. 106, lines 54 – 58; col. 107, lines 13 – 17; figures 2C, 51A, 51B and 52C); and
analyzing the droplet at one or more locations along the single path on the surface of the cartridge (col. 98, lines 19 – 25; col. 105, lines 29 – 35).
Regarding claim 2, Huff teaches the method of claim 1, wherein the plurality of particles comprises at least one paramagnetic, bar-coded bead (col. 5, lines 26 and 27; col. 30, line 66 – col. 31, line 1; col. 36, lines 15 – 20; col. 46, line 66 – col. 47, line 22).
Regarding claim 3, Huff teaches the method of claim 2, wherein the at least one paramagnetic, bar-coded bead comprises one or more unique bar codes (col. 46, line 66 – col. 47, line 22).
Regarding claim 4, Huff teaches the method of claim 2, wherein the at least one paramagnetic, bar-coded bead comprises at least one non-spherical, paramagnetic, bar-coded bead (col. 30, line 66 – col. 31, line 1; col. 45, line 41; col. 46, line 66 – col. 47, line 11).
Regarding claim 5, Huff teaches the method of claim 2, wherein the at least one paramagnetic, bar-coded bead is between approximately 0.1 to 100 microns in size (col. 46, line 23 – 58).
Regarding claim 6, Huff teaches the method of claim 1, wherein single path on the surface of the cartridge comprises a dielectric material, and wherein transporting, via a plurality of electrodes of the cartridge, the droplet on the surface of the cartridge comprises applying an electric current to the electrodes of the cartridge (col. 73, line 55 – col. 74, line 7).
Regarding claim 7, Huff teaches the method of claim 6, wherein the electric current comprises a direct electric current (col. 56, lines 25 – 46).
Regarding claim 8, Huff teaches the method of claim 6, wherein the electric current comprises an alternating electric current (col. 24, lines 28 – 48).
Regarding claim 11, Huff teaches the method of claim 1, wherein the method further comprises immobilizing, via at least one magnet of the cartridge, the droplet at a particular location along the single path on the surface of the cartridge, wherein the at least one magnet is configured to immobilize the droplet along the single path on the surface of the cartridge (col. 35, lines 62 – 65; col. 36, lines 15 – 67).
Regarding claim 12, Huff teaches the method of claim 11, wherein immobilizing, via at least one magnet of the cartridge, the droplet at a particular location along the single path on the surface of the cartridge, comprises immobilizing the at least one paramagnetic, bar-coded bead of the droplet (col. 6, lines 26 and 27; col. 30, line 66 – col. 31, line 1; col. 36, lines 15 – 67; col. 46, line 66 – col. 47, line 11).
Regarding claim 13, Huff teaches the method of claim 11, wherein analyzing the droplet at one or more locations along the single path on the surface of the cartridge comprises analyzing the droplet while the droplet is immobilized at a particular location along the single path on the surface of the cartridge (col. 5, lines 26 and 27; col. 30, line 66 – col. 31, line 1; col. 36, lines 15 – 67; col. 98, lines 19 – 25).
Regarding claim 14, Huff teaches the method of claim 11, wherein the method further comprises transporting along the single path an additional droplet, wherein the additional droplet comprises at least one of a sample and a reagent, and wherein the additional droplet interacts with the immobilized droplet (col. 36, lines 15 – 42; col. 69, lines 40 – 43).
Regarding claim 21, Huff teaches the method of claim 1, wherein analyzing the droplet at one or more locations along the single path on the surface of the cartridge comprises performing one or more assay procedures on the droplet at the one or more locations along the single path on the surface of the cartridge, and wherein, during the one or more assay procedures, determining a parameter of the droplet (col. 85, lines 41 – 48; col. 100, lines 29 – 32; col. 101, lines 23 – 27; col. 103, lines 43 – 47).
Regarding claim 22, Huff teaches the method of claim 21, wherein determining a parameter of the droplet comprises identifying a particular feature of the plurality of particles (col. 85, lines 41 – 48).
Regarding claim 23, Huff teaches the method of claim 22, wherein analyzing the droplet at one or more locations along the single path on the surface of the cartridge comprises generating an image of the droplet at the one or more locations along the single path on the surface of the cartridge, wherein the image comprises an image of the plurality of particles (col. 24, lines 25 – 27; col. 77, lines 14 – 24; col. 77, lines 52 – 58, col. 112, lines 50 – 55; col. 77, lines 30 – 33); and
based on the generated image, determining a parameter of the droplet (col. 85, lines 41 – 44).
Regarding claim 24, Huff teaches the method of claim 23, wherein determining a parameter of the droplet comprises comparing the generated image of the droplet to a previously generated image of the droplet (e.g., via CMOS or CCD cameras; col. 77, lines 30 – 33; col. 85, lines 41 – 44).
Regarding claim 25, Huff teaches the method of claim 23, wherein analyzing the droplet further comprises, while generating an image of the droplet at the one or more locations along the single path on the surface of the cartridge, applying an ultraviolet light to the droplet (e.g., via CMOS or CCD cameras; col. 77, lines 30 – 33; col. 85, lines 41 – 44; col 120, lines 15 and 16).
Regarding claim 26, Huff teaches the method of claim 21, wherein the method further comprises: transmitting instructions that cause a graphical user interface to display a graphical representation of the determined parameter of the droplet (col. 24, lines 25 – 27; col. 77, lines 14 – 24; col. 77, lines 30 – 58; col. 112, lines 50 – 55).
Regarding claim 27, Huff teaches the method of claim 1, wherein analyzing the droplet at one or more locations along the single path on the surface of the cartridge comprises performing a plurality of assay procedures on the droplet at the one or more locations along the single path on the surface of the cartridge, and wherein, during the plurality of assay procedures, determining a presence of one or more analytes adhered to the at least one paramagnetic, barcoded bead of the droplet (col. 5, lines 26 and 27; col. 30, line 66 – col. 31, line 1; col. 36, lines 15 – 67; col. 46, line 66 – col. 47, line 11; col. 100, lines 29 – 32; col. 101, lines 23 – 27col. 103, lines 43 – 47).
Regarding claim 28, Huff teaches the method of claim 1, wherein the droplet further comprises a solution for washing the plurality of particles of the droplet (e.g., via a wash step; col. 32, lines 6 – 52).
Regarding claim 30, Huff teaches a non-transitory computer-readable medium, having stored thereon program instructions that, upon execution by a controller, cause a controller to perform a set of operations (col. 78, lines 12 – 19; col. 76, line 47 – col. 78, line 12) comprising:
transporting, via a plurality of electrodes of a cartridge, a droplet along a single path on a surface of the cartridge, wherein the droplet comprises a plurality of particle, and wherein the single path is substantially linear and the plurality of electrodes is configured to transport the droplet along the single path on the surface of the cartridge (col. 73, lines 21 – 32; col. 74, lines 59 – 64; col 96, line 34 – col. 97, line 7; col. 98, lines 19 – 25; col. 105, lines 18 – 21; col. 106, lines 54 – 58; col. 107, lines 13 – 17; figures 2C, 51A, 51B and 52C); and
analyzing the droplet at one or more locations along the single path on the surface of the cartridge (col. 98, lines 19 – 25; col. 105, lines 29 – 35).
Regarding claim 31, Huff teaches a cartridge (col. 19, lines 42 – 49) comprising:
a plurality of electrodes (col. 19, lines 42 – 49; col. 73, lines 21 – 31);
a single path for transporting a droplet on a surface of the cartridge, wherein the single path is substantially linear and the plurality of electrodes is configured to transport a droplet along the single path on the surface of the cartridge, and wherein the droplet comprises a plurality of particle (col. 73, lines 21 – 32; col. 74, lines 59 – 64; col 96, line 34 – col. 97, line 7; col. 98, lines 19 – 25; col. 105, lines 18 – 21; col. 106, lines 54 – 58; col. 107, lines 13 – 17; figures 2C, 51A, 51B and 52C); and
one or more locations for analyzing the droplet along the single path on the surface of the cartridge (col. 98, lines 19 – 25; col. 105, lines 29 – 35).
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 9, 10 and 15 – 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huff et al. (US 11,016,053 B2; hereinafter “Huff”).
Regarding claim 9, Huff does not specifically teach the method of claim 1, wherein the single path on the surface of the cartridge further comprises a sample reservoir and a waste reservoir.
However, Huff does teach the use of multiple reservoirs in other embodiments (col. 7, lines 54 – 65; col. 61, lines 50 and 51) and waste reservoirs (col. 132, lines 7 – 25). It would have been within the ambit of a person of ordinary skill in the art to configure the cartridge with a sample reservoir and a waste reservoir to process and transfer various sample, reagent and other fluids within the cartridge as needed. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Furthermore, the Supreme Court decision in KSR International Co. v. Teleflex Inc., 550 U.S. 82 USPQ2d 1385 (2007) has affirmed that the threshold requirement for a prima facie case of obviousness is “demonstrating that each element was, independently, known in the prior art.” Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the single path on the surface of the cartridge further comprises a sample reservoir and a waste reservoir so that the cartridge can handle processing and analyzing multiple fluids. Examiner submits that these arguments are in line with the Supreme Court unanimous opinion, KSR International v. Teleflex, Inc., 127 S. Ct. 1727, 1741 (2007), in which the Court stated that “[a] court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions.” Id. at 1731.
Regarding claim 10, Huff teaches the method of claim 9, wherein analyzing the droplet at one or more locations along the single path on the surface of the cartridge comprises analyzing the droplet in the sample reservoir (col. 131, lines 63 – col. 132, line 6; figures 13A and 13B).
Regarding claim 15, Huff does not specifically teach the method of claim 14, wherein the additional droplet is transported along the single path such that the additional droplet interacts with the immobilized droplet more than once.
However, Huff does teach that beads may be interacted with more than one additional droplet (col. 36, lines 23 – 42; col. 113, lines 50 – 55). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the additional droplet is transported along the single path such that the additional droplet interacts with the immobilized droplet more than once, in order to facilitate additional processing, reacting or analysis steps or washing steps as needed.
Regarding claim 16, Huff does not specifically teach the method of claim 15, wherein during the analyzing the droplet at one or more locations along the single path on the surface of the cartridge, an increased analysis signal is produced due to the more than one interaction between the droplet and at least one of the sample and the reagent of the additional droplet.
However, Huff does teach that beads may be interacted with more than one additional droplet (col. 36, lines 23 – 42; col. 113, lines 50 – 55). The additional droplets can contain reagents comprising tags, cleavage reagents or secondary reagents for enhanced signal detection. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein during the analyzing the droplet at one or more locations along the single path on the surface of the cartridge, an increased analysis signal is produced due to the more than one interaction between the droplet and at least one of the sample and the reagent of the additional droplet so that more accurate detection data can be acquired.
Regarding claim 17, Huff does not specifically teach the method of claim 11, wherein immobilizing, via at least one magnet of the cartridge, the droplet at a particular location along the single path on the surface of the cartridge, comprises immobilizing the at least one paramagnetic, bar-coded bead of the droplet and wherein the method further comprises transporting fluid contained in the droplet to a waste reservoir.
Huff does teach immobilizing the at least one paramagnetic, barcoded bead within a droplet (col. 5, lines 26 and 27) and processing the droplet (col. 46, line 66 – col. 47, line 11).
Huff does teach the use of multiple reservoirs in other embodiments (col. 7, lines 54 – 65; col. 61, lines 50 and 51) and waste reservoirs (col. 132, lines 7 – 25). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein immobilizing, via at least one magnet of the cartridge, the droplet at a particular location along the single path on the surface of the cartridge, comprises immobilizing the at least one paramagnetic, bar-coded bead of the droplet and wherein the method further comprises transporting fluid contained in the droplet to a waste reservoir, so that unwanted fluids are effectively removed.
Regarding claim 18, Huff teaches the method of claim 17, wherein the method further comprises transporting along the single path an additional droplet, wherein the additional droplet comprises at least one of a sample and a reagent, and wherein the additional droplet interacts with the immobilized at least one paramagnetic, bar-coded bead (col. 5, lines 26 and 27; col. 30, line 66 – col. 31, line 1; col. 36, lines 15 – 67; col. 46, line 66 – col. 47, line 11; col. 69, lines 40 – 43).
Regarding claim 19, Huff teaches the method of claim 18, wherein the additional droplet is transported along the single path such that the additional droplet interacts with the immobilized at least one paramagnetic, bar-coded bead more than once (col. 36, lines 23 – 42).
Regarding claim 20, Huff teaches the method of claim 19, wherein the method further comprises analyzing the at least one paramagnetic, bar-coded bead, and wherein during the analyzing the at least one paramagnetic, bar-coded bead at one or more locations along the single path on the surface of the cartridge (col. 5, lines 26 and 27; col. 30, line 66 – col. 31, line 1; col. 36, lines 15 – 67 and col. 46, line 66 – col. 47, line 11), wherein implicitly an increased analysis signal is produced due to the more than one interaction between the at least one paramagnetic, bar-coded bead and at least one of the sample and the reagent of the additional droplet.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huff et al. (US 11,016,053 B2; hereinafter “Huff”) in view of Chamberlin et al. (US 2022/0196638 A1; hereinafter “Chamberlin”).
Regarding claim 29, Huff does not specifically teach the method of claim 1, wherein the droplet further comprises a read buffer solution.
However, Chamberlin teaches pertinent assay apparatus and methods using read buffers that enhance automated sampling, sample preparation and analysis (paragraphs 111, 211, 245 and 247). Consequently, as evidenced by Chamberlin, the use of a read buffer would have been considered to be suitable and predictable to a person of ordinary skill in the art. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide wherein the droplet further comprises a read buffer solution in order to enable more effective sample detection and analysis.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796
