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
Status of the Claims
Claims 1-2 are pending and the subject of this FINAL Office Action.
Withdrawn Rejection
The Anticipation rejection based on TAKEDA (US 8,248,604) is withdrawn because it fails to recite valves or three independent pressure sources.
Claim Interpretations
During examination, claims receive the broadest reasonable interpretation in light of the specification. MPEP § 2111. Applicants are also reminded that “[a]n essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous” because “[o]nly in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.” In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989). Finally,
the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiners demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation.
Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255 (Fed. Cir. 2008).
Claims 1-2 encompass controlling pressure to maintain flow rates constant (which therefore yields constant flow width). In fact, this is explicitly described in the Specification (pg. 23). This is routine in the art.
Claims 1-2 are amended to recite “wherein a sample flow rate is controlled by controlling pressures which are applied to the first reservoir, the second reservoir, and the fourth reservoir, separately.” However, this encompasses valving to control the flow of each reservoir. In other words, if there are three reservoirs, there could be two pressure sources, and valves to allow one or more of the pressure sources to control multiple reservoirs.
It is also noted that the actual invention disclosed is a device used to sort cells, which is not claimed. Instead, the claims are directed to a mere flow path cartridge with channels and reservoirs controlled by pressure sources. This encompasses a large amount of prior art, and will likely prevent a finding of allowable subject matter, even if TAKEDA is somehow overcome.
Claim Rejections - 35 USC § 102 - Maintained
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 –
(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 1-2 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by TAKEDA (US 2012/0288920).
As to claims 1-2 TAKEDA teaches first path 1/27, second path 2 (right or left), third path 2 (right or left), fourth path 4-1 and fifth path 4-2 (Figs. 2-4), and maintaining pressure in paths 2, 27 and 4-1 and 4-2 so that “[t]he width of the sample liquid after joining is about one-tenth of the width of the flow path” (para. 0100). The paths and reservoirs/tanks of TAKEDA are used for identical purpose as that claimed (e.g. sheath liquid surrounds sample liquid in flow channel, Figs. 1-3). A discharge reservoir 11 and 5 is also included (Fig. 4).
Response to Arguments
Applicants’ arguments do not convince the Examiner that He erred because, first, examples from the specification will not be imported into the claims that do not explicitly do so; second, the claim breadth encompasses valve configurations of the cited prior art; finally, TAKEDA teaches a third pressure source for sample reservoir. Applicants argue that
the claimed invention requires the different pressures being separately applied to the first reservoir, the second reservoir, and the fourth reservoir respectively, as shown in the below annotated FIGS. 2(A) and (E). More specifically, the first reservoir (11) is air-pressed by the hallow needle (30), the second reservoir (12) is air-pressed by the hallow needle (31), and the fourth reservoir (21) is air-pressed by the hallow needle (34)
(Reply, pg. 5). However, the claims do not require the first reservoir (11) is air-pressed by the hallow needle (30), the second reservoir (12) is air-pressed by the hallow needle (31), and the fourth reservoir (21) is air-pressed by the hallow needle (34). As explained above, all that is required is “a sample flow rate is controlled by controlling pressures which are applied to the first reservoir, the second reservoir, and the fourth reservoir, separately.” To this end, Takeda teach valves to control pressures in each reservoir (e.g. paras. 0025-27).
Regardless, TAKEDA (US20120288920) teaches
As shown in FIG. 4, a predetermined air pressure may apply to the inside of the reservoir 20 positioned at the upstream end of the chip by a constant-pressure pump which is not shown in FIG. 4. A sample reservoir 10 is formed in the reservoir 20, and the sample liquid is poured into the sample reservoir and the sheath liquid is poured into the outside of the sample reservoir. Phosphate buffer saline (PBS) is preferably used as the sheath liquid. The air pressure common to the sample reservoir and the reservoir 20, causes the sample liquid 1 and the sheath liquid 2 to the right and left of the sample liquid to flow downstream. The three flow paths are joined and the sample liquid flows thinly in the joining flow path 27 while surrounded by the sheath liquids. The width of the flow path 27 is 80 μm and a depth thereof is 50 μm. The width of the sample liquid after joining is about one-tenth of the width of the flow path. The flow path 27 has the oppositely-branched sorting flow paths 4-1 and 4-2 on sides thereof, and the oppositely-branched sorting flow paths connect with the reservoir 5
(para. 0100). In other words, a third pressure source (other two are 8-1 and 8-2 in Fig. 4) is added in order to provide pressure to the sample reservoir 10/20. This allows independent/individual control of three different reservoirs.
Prior Art
The following prior art, among many, demonstrates that independent pressure sources for each reservoir, including syringes/pistons were routine in the art: US 20020153047 (“In the case of pressure-based systems, operation of the overall system including a valve module typically involves the application of a negative or positive pressure source that is operably coupled to one of the inlet side or outlet side of the overall system, e.g., reservoir 112 or 114, respectively, in FIG. 1. Pressure control also involves the use of controllable pressure sources (positive and/or negative) operably coupled to the reservoirs in the valve module, e.g., reservoirs 116 and 118, where the pressure source or sources coupled to the inlet and outlet sides of the channel system are independently controllable from each other and/or the pressure sources coupled to the valve module. Examples of systems that include multiple, independently controllable pressure sources are described in, e.g., published International Patent Application No. WO 01/63270, which is incorporated herein by reference in its entirety for all purposes. Typically, such systems employ multiple independent pressure pumps, e.g., syringe pumps that are separately operably coupled to each of the reservoirs at which more active and precise control of pressures is desired, e.g., the valve module reservoirs and at least one of the inlet and/or outlet side reservoirs. Control of flow can be accomplished either by monitoring flow while adjusting relative flow rates until the desired flow profile is achieved, or by predetermining the parameters of the control system and channel network, and operating within those parameters (see, e.g., PCT Application NO WO 01/63270, incorporated above).”).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON PRIEST whose telephone number is (571) 270-1095. The examiner can normally be reached on Monday-Friday 10am-6pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached on 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON A PRIEST/Primary Examiner, Art Unit 1681