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 Group I, claims 1-17, in the reply filed on 05/15/26 is acknowledged.
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.
Claim 11 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.
Regarding claim 11, the claim recites a fourth chamber containing a detection reagent. The claim limitation raises indefiniteness issue as it is unclear if “a detection reagent” is referring to “a detection reagent” of claim 9 or a second detection reagent that is different from the detection reagent of claim 9.
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.
Claim(s) 1, 7, 8, 12, 14, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pieprzyk (US 20140045184 A1) as cited in IDS.
Regarding claim 1, Pieprzyk teaches a test device, comprising: a body (Figure 1, 180; the body is interpreted as being defined by the block 180);
at least one fluid passageway (channel 130, Fig. 1; channel 330, Fig. 3) extending within the body, the at least one fluid passageway comprising an inlet (inlet of channel 130, denoted as arrow A in Fig. 1; inlet of channel 330 in Fig. 4) and a plurality of chambers in adjacent, spaced-apart relationship (chambers 120 and 140, Fig. 1 and 320 and 340, Fig. 3; the chambers are fluidly connected to each other via the channels including 130), the at least one fluid passageway configured for sequential passage of a fluid sample through (interface valve 162 (open); Fig. 2) at least some of the plurality of chambers (As shown here with reference to the “B” arrows, the first material can flow from first reaction chamber 140, through via 131, through reaction channel 170, past interface valve 162, through via 111, and into second reaction chamber 120, para. [0158]);
and a plurality of isolation valves, each isolation valve selectively operable to control fluid flow into and out of one or more of the plurality of chambers (a first isolation valve 132 and a second isolation valve 112, Fig. 1).
Regarding claim 7, Pieprzyk teaches the device of Claim 1. Pieprzyk further teaches wherein the body comprises a translucent or transparent polymeric material (Because the devices can be made of materials that are relatively optically transparent (e.g., elastomeric materials), para. [0084]).
Regarding claim 8, Pieprzyk teaches the device of Claim 7. Pieprzyk further teaches the polymeric material is PDMS (para. [0137]).
Regarding claim 12, Pieprzyk teaches the device of Claim 1. Pieprzyk further teaches wherein the plurality of chambers comprise a chamber (chamber 140, Fig. 1) configured to receive an input sample (With reference to the "A" arrows in FIG. 1, a first material, such as an assay reagent, can flow through first channel 130, past first isolation valve 132, and into first chamber 140. Similarly, with reference to the "B" arrows, a second material, such as an assay sample, can flow through second channel 110, past second isolation valve 112, through via 111, and into second chamber 120, para. [0149]), and a detection chamber (second chamber 120, Fig. 1) containing a detection reagent configured to undergo a visually detectable change (Often, the presence, absence, or extent of any reaction between the first and second materials, or involving either or both of the first and second materials, within the second reaction chamber can be characterized, confirmed, detected, or quantified by inspection, for example with a reader, sensor, or imaging device 190. Para. [0158]).
Regarding claim 14, Pieprzyk teaches the device of Claim 1. Pieprzyk further teaches wherein the at least one fluid passageway comprises a plurality of fluid passageways in adjacent, spaced apart relationship (Figure 1, channels 110 and 130; Note that the channels 110 and 130 are interpreted as each defining an individual fluid passageway, with each of the passageways in an adjacent, spaced apart relationship).
Regarding claim 15, Pieprzyk teaches the device of Claim 1. Pieprzyk further teaches wherein the at least one fluid passageway comprises two or more fluid passageways that are used to test for a presence of two or more target molecules (Figure 1; and Figure 3; FIG. 3 illustrates a perspective view of a matrix 300 having four unit cells ... arranged in two rows and two columns ... It is appreciated that the unit cell architecture embodiments disclosed herein can be scaled to provide a matrix having any number of desired unit cells … Consequently, a greater number of samples can be analyzed within the block during a single procedure; para. [0159]-[0160]; Note that since four unit cells are depicted in Figure 3, where an individual unit cell is depicted in Figure 1, this is interpreted as teaching at least four fluid passageways, each used to test for the presence of a target molecule, thus providing testing for the presence of four target molecules).
Claim Rejections - 35 USC § 103
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pieprzyk in view of Yuan (US 20100102261 A1) as cited in IDS.
Regarding claim 2, Pieprzyk teaches the device of Claim 1 but does not teach wherein each isolation valve comprises a port extending within the body transverse to the at least one fluid passageway and a rod slidably or rotatably movable within the port. Pieprzyk discloses device is configured to uses restriction features, which can include valve or actuated element such as a guided pin (para. [0024])
In an analogous art, Yuan teaches a valve mechanism for use with microfluidic devices, comprising a fluid inlet (input channel 10, Fig. 3) and a fluid outlet (output channel 12, Fig. 3) defining a fluid passageway, a port extending within the fluid passageway (plunger channel 14, Fig. 3), and a rod/plunger which is slidably movable within the port (Figure 3, plunger 20)(Abstract, para [0013], [0015], [0027], and [0028]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have tried substituting an appropriate valve mechanism, such as the one taught by Yuan, place of the isolation valve(s) in the device as taught by Pieprzyk to derive the claimed invention as Pieprzyk discloses flow restriction/manipulation can be done using guided pin (para. [0023]-[0024]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pieprzyk in view of Ismagilov (US 20140202546 A1) as cited in IDS.
Regarding claim 3, Pieprzyk teaches the device of Claim 1 but does not teach wherein at least one of the plurality of chambers is funnel or flute-shaped to facilitate fluid flow into an adjacent, downstream chamber.
In an analogous art, Ismagilov teaches an adapter for connecting channels of microfluidic chips together, where the adapter is funnel shaped to facilitate fluid flow from a first chamber into a second downstream channel (Figure 15, adapter 2 and chip 24).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the shape of at least one chambers of the device as taught by Pieprzyk to funnel-shape as taught by Ismagilov to derive the claimed invention. Using a funnel-shape may preferentially connects components/channels of the device of Pieprzyk (Ismagilov, para. [0024]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pieprzyk in view of Yuan as applied to claim 2 above, and further in view of Fluga as cited in IDS (US 5101556 A).
Regarding claim 4, Modified Pieprzyk teaches the device of Claim 2 as discussed above but does not teach wherein each rod is a carbon fiber rod.
In an analogous art, Fluga teaches a piston which comprises a carbon fiber material, where the carbon fibers are effective to reinforce the body of the piston (Figure 1; and Abstract, A method of manufacturing a piston for transferring an output force to a member in responsive to pressurized fluid being communicated to a bore in a housing. The piston has a cylinder body made of a plurality of triaxial braided layers of carbon fibers…).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have tested and substituted the rod material of Yuan (after incorporation with Pieprzyk), by routine experimentation, with carbon fiber as taught by Fluga to derive the claimed invention in order to test the effectiveness of rod material handling pressurized fluid (Abstract, Fluga).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pieprzyk in view of Yuan as applied to claim 2 above, and further in view of Matkovich as cited in IDS (US 4,976,926 A).
Regarding claim 5, Modified Pieprzyk teaches the device of Claim 2 as discussed above but does not teach wherein the port has a polygonal cross-sectional configuration, and wherein the rod has a corresponding polygonal cross-sectional configuration such that the rod is snugly movable within the port.
In an analogous art, Matkovich teaches a diagnostic device comprising a rod/piston which is held within a bore/port, where both rod/piston and bore/port can have a square cross-sectional shape (Figure 2; and col 11 In 1-3, Alternatively, a non-circular piston, e.g., a square piston, and commensurately shaped bore may be employed).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the shape of the rod and port having a circular-shaped cross-section as taught by Yuan (after incorporation into Pieprzyk) with square cross-sectional shape as taught by Matkovich, by routine experimentation, to derive a configuration with a polygonal cross sectional ports and rods, wherein the rod has a corresponding polygonal cross-sectional configuration such that the rod is snugly movable within the port. Using a polygonal shape may prevent unwanted rotation of the circular rods within the circular ports (Matkovich, The piston is also provided with a means to prevent rotation within the upper housing section, such as by employing a key either on one of an internal surface of the bore or the peripheral surface of the piston and a keyway on the other of the surfaces. Col. 10, ln 65- col. 11, ln 1).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pieprzyk in view of Yuan as applied to claim 2 above, and further in view of Atkinson (US 5,653,264 A) as cited in IDS.
Regarding claim 6, Modified Pieprzyk teaches the device of Claim 2 as discussed above but does not teach wherein each rod has visual indicia to correlate to a respective chamber.
However, Atkinson does teach a plastic body which is molded of a color related to the size of the orifice, thus providing visual indicia for identification of the body (Abstract, An orifice device includes a pneumatic orifice fitting having a molded tubular plastic body ... The orifice body is molded of a color related to the size of the orifice and the color is visible through the body and particular the hex portion. Other forms of visible indicia may be used).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to provide an appropriate identification mechanism for the valves and rods in Modified Pieprzyk by specifically providing the colored visual indicia as taught by Atkinson. This advantageously provides an identification mechanism for the individual valves in Modified Pieprzyk.
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pieprzyk in view of Li (Instrument-free, CRISPR-based diagnostics of SARS-CoV-2 using self-contained microfluidic system, 2022) as cited in IDS.
Regarding claim 9, Pieprzyk teaches the device of Claim 1. Pieprzyk further teaches wherein the plurality of chambers comprise a first chamber configured to receive an input sample (a sample chamber for containing a sample fluid; para. [0020]; Fig. 13, sample channel 904 connected to a sample chamber (not shown)), a second chamber (a reagent chamber for containing a reagent fluid, para. [0020]; Fig. 13, reagent channel 908 connected to a reagent chamber (not shown)) containing an amplification reagent (para. [0072]), and a third chamber (902, Fig. 13) wherein the reaction chamber can be analyzed with an imaging reader (Often, the presence, absence, or extent of any reaction between the first and second materials, or involving either or both of the first and second materials, within the second reaction chamber can be characterized, confirmed, detected, or quantified by inspection, for example with a reader, sensor, or imaging device 190. Para. [0158]). Pieprzyk does not specifically teach the third chamber containing a detection reagent.
Analogous art Li does teach a microfluidic chip for the detection of SARS-CoV-2, which comprises a first chamber for RT-RPA amplification and a second chamber for CRISPR-Cas12a cleavage reactions. and a third downstream chamber comprising a lateral flow strip (reagent in LFS is interpreted as the detection reagent) for visual detection (Abstract, Here, we developed a simple, sensitive, instrument-free, CRISPR-based diagnostics of SARS-CoV-2 using a self-contained microfluidic system; and Figure 1B and its caption).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the CRISPR-Cas12a reagent in CRISPR chamber taught by Li to the reaction chamber/third chamber of the device as taught by Pierprzyk to specifically provide the first chamber configured to receive an input sample and a second chamber containing an amplification reagent, and third third chamber for CRISPR cleavage reaction of device of Pierprzyk in order to advantageously provide the application of effectively testing for the presence of pathogenic or viral sample.
Regarding claim 10, Modified Pierprzyk teaches the device of Claim 9 as discussed above. Li, after incorporation with Pierprzyk, further teaches wherein the detection reagent includes a CRISPR/Cas reagent (pg 2 col 1 para 2).
Regarding claim 11, Modified Pierprzyk teaches the device of Claim 9 as discussed above. Li (after incorporation with Pierprzyk) further teaches further comprising a fourth chamber containing a detection reagent (reagent in LFS is interpreted as the detection reagent) (Abstract, Here, we developed a simple, sensitive, instrument-free, CRISPR-based diagnostics of SARS-CoV-2 using a self-contained microfluidic system; and Figure 1B and its caption) configured to undergo a visually detectable change (Figure 1, Note that the chamber which holds the lateral flow strip is interpreted as the fourth chamber containing a detection reagent configured to undergo a visually detectable change, where the detection reagent is held on the test band depicted in Figure 2C) .
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pierprzyk in view of Unno (US 20040141884 A1) as cited in IDS.
Regarding claim 13, Pierprzyk teaches the device of Claim 1 but does not teach wherein the body comprises indicia that indicates a proper orientation of the device during use.
However, Unno does teach a microfluidic device which comprises various structures such as pins, posts, blocks, tabs, which acts as indicia that indicate a proper orientation of the device during use (Abstract, Microfluidic devices and systems that include keying, registration or indication elements that communicate a functionality of the microfluidic device to the instrumentation which is used in conjunction with these devices; and para [0025], A variety of registration or indicator structures are
optionally employed in this aspect of the present invention. For example, a series of pins, posts, blocks, tabs).
Therefore, it would have been obvious to one of ordinary skill in the art to provide appropriate indicia for ensuring that the device as taught by Pierprzyk maintains a proper orientation, for example to provide any of the various structures as taught by Unno, thus advantageously providing a device with a body that comprises indicia that indicate a proper orientation of the device during use.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pierprzyk in view of Katz (US 20180339292 A1) as cited in IDS.
Regarding claim 16, Pierprzyk teaches the device of Claim 1 but does not teach wherein the body is configured to be opened such that the fluid sample can be accessed from one of the plurality of chambers.
In an analogous art, Katz teaches an assay device which comprises an actuating lid, such that a user can obtain a sample from a chamber within the assay device (Figure 1, 2; and Figure 6A, lid 2 and swab 17; para [0043]).
Therefore, it would have been obvious to one of ordinary skill in the art to provide an appropriate mechanism for accessing the chambers of the device as taught by Pierprzyk, specifically to couple the actuating lid of Katz with the body of the device of Pierprzyk to derive the claimed invention. Doing so provides a mechanism for allowing a user to access the interior chambers of the device (Katz, para [0055], Actuation of lid 2 allows a user to simply and easily insert an item ... i.e., a sampling device such as swab 17 ... into the mixing chamber 14 via opening 13, without the item itself directly puncturing the puncturable seal).
Regarding claim 17, Modified Pierprzyk teaches the device of claim 16. Pierprzyk does not explicitly teach the body is configured to be opened such that a detection strip can be dipped or such that a pipette can obtain the fluid sample. The limitation of “such that a detection strip can be dipped or such that a pipette can obtain the fluid sample” is recitation of intended use. Manner of operating an apparatus does not differentiate apparatus claim from the prior art. A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114, II). A recitation of intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Moreover, Katz, after incorporation into Pierprzyk, discloses a swab can be inserted to sample the fluid after opening the lid (para. [0055]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICKEY HUANG whose telephone number is (571)272-7690. The examiner can normally be reached M-F 9:30-5:30 PM ET.
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/M.H./ Examiner, Art Unit 1758
/MARIS R KESSEL/ Supervisory Patent Examiner, Art Unit 1758
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