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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-9 in the reply filed on 06/12/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-9 are being examined.
Claim Objections
Claim 1 is objected to because of the following informalities: Examiner suggests:
“the first and second channel ports” to read ‘the first channel port and the second channel port.’
“first and second valve positions” to read ‘a first valve position and a second valve position.’
Appropriate correction is required.
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) 1-9 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by “Smith” (Smith et al., US 2008/0038737 A1 with incorporated references Christel et al. U.S. Pat. No. 6,369,893 and Dority, U.S. Pat. No. 6,374,684).
Regarding claim 1, Smith teaches:
1. A system comprising:
a microfluidic body (e.g., 2000) having a body side (see Fig. 2A for example) and a fluidic network that includes a supply port (i.e., any of 2016, 2020, 2024, 2028, 2032, 2036) and a feed port (i.e., any of 2040, 2044), the supply port opening to the body side (see Fig. 2A for example);
a rotary valve (e.g., 2002) that is rotatably mounted to the body side (see Fig. 2A for example), the rotary valve having a first channel port (i.e., upstream side “port” such as a connecting passage 2010, 2011, 2013, or associated passages 2008, 2012), a second channel port (i.e., downstream side “port” such as a connecting passage 2010, 2011, 2013, or associated passages 2008, 2012), and a flow channel (i.e., a channel of 2010, 2011, 2013, 2008, 2012) that extends between the first channel port and second channel port (see i.e., “[...] connecting passages (2010), (2011), and (2013), which permit a port in one plane of the valve to be placed in fluid communication with ports of housing (2000) that are in the other plane of rotary valve (2002). [...] As illustrated in FIG. 2A, when such connecting passages are aligned at (2046) with ports of passages (2044) and (2016), passages (2044) and (2016) are in fluid communication.” ¶ 0074), the rotary valve configured to rotate between first valve position (position in Fig. 2C) and second valve position (position in Fig. 2E), the first channel port being in flow communication with the supply port of the microfluidic body when the rotary valve is in the first valve position (¶ 0077), the first channel port being sealed by the microfluidic body when the rotary valve is in the second valve position (¶ 0077); and
a pump assembly (e.g., piston-type pump 2006) configured to induce a flow of a fluid through the supply port and into the flow channel when the rotary valve is in the first valve position (see i.e., “Up-strokes of piston (2056) of pump (2006) pressurize chamber (2004) and force fluid contents out through whatever ports that may be in communication with reservoirs or the like; likewise, down strokes of piston (2056) of pump (2006) depressurize chamber (2004) and draw fluids in through whatever ports may be open and in communication with reservoirs or the like. Further descriptions of the operation and construction of such pump-rotary valve devices and the use of chamber (2004) for sample preparation is provided by Dority (cited above), which is incorporated by reference for this purpose.” ¶ 0074; “An up-stroke of piston (2056) drives the mixture of lysing reagent and sample, referred to as the "lysate" or simply the "sample," from interior chamber (2004) into sample reservoir (2022).” ¶ 0077 & Figs. 2A, 2C for example); and
a thermocycler (e.g., thermal cycler instrument ¶ 0037, thermal element ¶ 0051, temperature controller for amplification reaction ¶ 0071) positioned relative to the rotary valve and capable of controlling a temperature experienced by the fluid within the flow channel (see ¶ 0071-0073+ for example; see also thermal cycler 62 and thermal cycling system 60 of the incorporated reference Christel et al. U.S. Pat. No. 6,369,893; and C6/L16-33 of the incorporated reference Dority, U.S. Pat. No. 6,374,684).
With regard to limitations in claim 1 (e.g., [...] controls a temperature experienced by the fluid within the flow channel when the rotary valve is in the second valve position.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 2-9, Smith teaches:
2. The system of claim 1, wherein the microfluidic body includes a reservoir port that opens to the body side and is in flow communication with a reservoir, the rotary valve being rotatable to a third valve position in which the first channel port and the reservoir port are aligned, the pump assembly configured to induce a flow of the fluid in the flow channel through the reservoir port and into the reservoir (see i.e., “An up-stroke of piston (2056) drives the mixture of lysing reagent and sample, referred to as the "lysate" or simply the "sample," from interior chamber (2004) into sample reservoir (2022).” ¶ 0077 & Fig. 2C for example).
3. The system of claim 2, wherein the pump assembly is configured to induce a flow of the fluid from the reservoir through the flow channel and through the feed port of the microfluidic body (see i.e., “An up-stroke of piston (2056) drives the mixture of lysing reagent and sample, referred to as the "lysate" or simply the "sample," from interior chamber (2004) into sample reservoir (2022).” ¶ 0077 & Fig. 2C for example).
4. The system of claim 1, wherein the rotary valve is configured to rotate about an axis, the second channel port and the feed port being aligned with the axis (see Fig. 2A; see also Figs. 8-9 of the incorporated reference Christel et al. U.S. Pat. No. 6,369,893.
5. The system of claim 1, wherein the flow channel is a first flow channel, the rotary valve including a second flow channel extending between corresponding channel ports (see i.e., Rotary valve (2002) has various ports, for example (2050) and (2052), and associated passages, (2008) and (2012), that permit chamber (2004) to be in fluid communication with various reservoirs (described more fully below) or reaction chamber (2042) whenever such ports are aligned with corresponding ports to passages to such reservoirs or reaction chamber (2042). In the present exemplary embodiments, the longitudinal axes of such associated passages are radially disposed in rotary valve (2002) within either one of two planes perpendicular to the axis of rotary valve (2002)(shown with dashed lines (2048) and (2049)), such that chamber (2004) may be placed in fluid communication with ports of passages to reservoirs, and the like, disposed in housing (2000). Rotary valve (2002) further includes connecting passages (2010), (2011), and (2013), which permit a port in one plane of the valve to be placed in fluid communication with ports of housing (2000) that are in the other plane of rotary valve (2002). ¶ 0074).
6. The system of claim 1, further comprising a reaction chamber (e.g., 1070/2042) in flow communication with the feed port (see ¶ 0077+ for example) and a detection device that is positioned to detect designated reactions within the reaction chamber (see ¶ 0065, Claims 1, 29+ for example).
7. The system of claim 6, wherein the reaction chamber has a remote location with respect to the rotary valve (see Fig. 1C for example).
8. The system of claim 6, wherein a flow cell includes the reaction chamber, the detection device being an imaging detector (see C15/L41-43 of incorporated reference Christel et al. U.S. Pat. No. 6,369,893) that is positioned adjacent to the flow cell (see Figs. 23-24 of incorporated reference Christel et al. U.S. Pat. No. 6,369,893).
9. The system of claim 8, wherein the imaging detector and the flow cell are secured to each other (see C15/L41-43 & Figs. 23-24 of incorporated reference Christel et al. U.S. Pat. No. 6,369,893).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES CAPOZZI can be reached at (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
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