45DETAILED 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 without traverse of Group I, claims 51-62 in the reply filed on November 1, 2024 is acknowledged.
Claims 63-69 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Response to Arguments
Applicant's arguments filed March 3, 2026 have been fully considered but they are not persuasive.
As to the art rejection applicant states:
“With respect to Yuan, there is no disclosure whatsoever relating to automatic control of the pressure applied to the flow channels. In fact, Yuan is not controlling pressure at all. Rather, Yuan measures pressure at one or more locations along the flow channels based on a set flow to determine viscosity (see, e.g., paragraphs [0078] and [0079] of Yuan). Thus, Yuan's disclosure addresses the problem of how to incorporate the pressure sensors into the device in a cost-effective and flexible manner (see, e.g., paragraph [0004] of Yuan). The Office Action relies on control means (7) in Fig. 2 of Yuan as teaching an automatic controller, but as disclosed in paragraph [0079] of Yuan, control means (7) controls the flow of fluid from micro pump (3), not pressure.”
The examiner disagrees. Yuan US 2013/0125627 discloses “the pumping means is a pressure pump, that is, pumping means adapted to drive the fluid flow by applying a controlled pressure to the fluid under test.” (paragraph 0035). “The micro pump is controlled to generate suction to draw sample liquid down from the micro reservoir into the flow channel 14 and also to fill the side-volumes inside the pressure sensor holes 22 and 23. After loading, the micro pump is then controlled to generate the desired flow and the pressure sensors are used to obtain measurements of fluid pressure at the two positions along the flow channel 14 with which the holes 22 and 23 are in communication.” (paragraph 0079). Controlling the flow (which is generate by the application of pressure and such flow produces, applies fluid pressure) in the flow channel is controlling pressure in the flow channels.
Yuan further discloses that “the apparatus also comprises pumping means 3 in the form of a pressure pump. This pressure pump comprises a high pressure source 31, such as a cylinder of compressed gas. This high pressure source 31 is connected to a controllable regulator 32 under the control of a controller 7. The controllable regulator 32 is connected to the reservoir 5 and determines a pressure of a volume V2 of fluid inside the reservoir and in contact with a surface of the volume of test fluid. The controller 7 controls the controllable regulator 32 to set the pressure of this volume of fluid V2 in the reservoir 5, and in this particular embodiment the pressure is controllable to any value up to the pressure of the high pressure source 31. Thus, the pressure pumping means sets a pressure applied to the test fluid and, by applying this pressure to the test fluid, causes test fluid to flow simultaneously along flow channels 14A and 14B. Thus, fluid flow can be driven with a constant pressure, if desired. The drive pressure in turn determines the flow rate of fluid through the plurality of flow channels. Although two flow channels are shown in the figure, in alternative embodiments the pressure pump may drive fluid flow in just a single channel, or along an even greater number of flow channels simultaneously. Advantageously, this pressure drive enables steady state flow conditions to be achieved rapidly, hence requiring only small volumes of sample (i.e. test) fluid. As steady state conditions are achieved rapidly, only small volumes of sample fluid may be consumed in arriving at that steady state condition. This pressure drive is in contrast to alternative embodiments in which the pumping means is arranged to displace some actuating membrane in contact with the test fluid so as to determine flow rate. Such simples include syringe pumps and piezo electric pumps. In such embodiments, where flow rate is controlled, the resultant pressure in the system is determined by flow rate.” (paragraph 0098). Therefore, Yuan clearly discloses a controller configured to automatically control the applied pressure of the pressure control unit.
Therefore, the rejection is hereby maintained.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
It is noted that claim 51 mentions a sample, air, and fluid. However, no sample, air, and fluid are positively claimed as elements of the invention. The prior mentioned are materials and/or articles that are intended to be worked upon and do not structurally define the claimed invention. Furthermore, it is noted that a fluid sample and a fluid recited throughout the claims are not required to be the same.
It is noted that the terms “inlet” and “outlet” are claimed as being any specific structures. The terms are moreso directed to the intended use of the structure. However, it is noted that structure labeled as an “inlet “is not necessarily precluded being used as an outlet and vice versa.
It is noted that the terms “or” and “and/or” provides for alternatives than are not requirements.
As to claim 57, it is presumed that “the automatic controller” is intended to be the same as the controller of claim 51. Therefore, for consistency it appears as if claim 51 should be amended to read as “an automatic controller”.
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 72-73 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 72-73 recite the limitation "the sample in each of the at least two microfluidic circuits”. There is insufficient antecedent basis for this limitation in the claims. It appears as if the claims should depend upon claim 61.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 51-53, 56-57, 59-62, and 70-74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yuan, WO 2012/017246 (US 20130125627 and US 9354152) and further in view of Sauter, US 6,149,815 or Wilding et al., US 2003/0199081.
Yuan discloses an assembly comprising:
a) a microfluidic cartridge (fig. 1 and 2, block 1) comprising at least two microfluidic circuits (fig. 3 and/or 4, channels 14a-14c), each microfluidic circuit comprising:
i) an inlet (fig. 2b, first holes 21a-21c);
ii) at least one microfluidic channel comprising:
a first channel section (constricting portions 141a-141c) having a first diameter and an end in direct fluidic communication with the inlet (fig. 2a-2b), and
a second channel section (fig. 3 and/or 4, see the right side portions of channels 14a-14c that follow constrictions 141 a-141 c) having an optically clear channel subsection, or being completely optically clear (page 13, line 4, transparent material), and having a second diameter greater than the first diameter, wherein the second section is in direct fluidic communication with the first section at an end opposite the inlet (see fig. 3 and/or 4), and
iii) an outlet (fig. 2b, fifth holes 25a-25c) in fluid communication with the second section at an end opposite the first channel section (fig. 2a-2b),
wherein the first channel section provides a resistance to a fluid traversing said microfluidic channel that is at least 80% and less than 100% of a combined resistance of the first and second channel sections, and/or of the microfluidic circuit (this clause is structurally unclear such that one cannot determine what is required by the clause as noted above).
b) an image recording system optically connected to the optically clear channel section of the at least two microfluidic circuits (page 5, 3rd par., "micro-particle image velocimetry and other rhea-optical measurements''); and
c) a pressure control unit (fig. 2, micro pump 3, regulator 32, and control means 7) configured to deliver fluid into each of the at least two microfluidic circuits.
d) an automatic controller (control means 7) operably coupled to the pressure control unit, wherein the controller is configured to automatically control the applied pressure of the pressure control unit. (paragraphs 0035, 79, 98 and Figure 1).
Yuan does not specify that the image recording system is a video camera configured to provide video, moving image of a fluid-air interface between a fluid sample and air within the microfluidic channel.
However, cameras that can provide for still images and video images were well known in the art prior to the filing date of the instant application.
Sauter discloses an apparatus comprising clear conduits/capillary tubes for transporting fluids. The apparatus employs a video camera connected to the video input of an RCA 2000 color monitor, and set the video equipment at approximately a 45 degree angle so that the liquid and the meniscus can be seen directly on the monitor and recorded on video tape. (column 4, lines 30-41).
Wilding discloses a device comprising microfluidic channel circuits. The device is manufactured from a transparent material that allows for contents of the channels to be viewed. (paragraphs 0020, 24). The device also comprises optical system 70 that includes a lens system for magnifying the channel contents, as well as a light source. The video camera 68 and screen 64 allow changes in sample fluid properties, such as flow properties or color, induced by the presence of polymerized polynucleotide, to be monitored visually and optionally recorded using the appliance. (paragraph 0046).
It would have been obvious to one ordinary skill in the art before the effective filing date of the invention to modify the device of Yuan to include an image recording system comprising a video camera to monitor and record properties of samples/fluids (including a fluid-air interface) transported within the device as taught by Sauter and Wilding.
As to claim 52, the reference discloses a third channel: fig. 3 and/or 4, the left side portions of channels 14a-c before constrictions 141a-c.
As to claim 53, "The steady flow rate" ... "(is) adjustable by means of suitable control of the micro pump 3 by the control means 7 the control means 7 which comprises a PC (programmable) and controller, AD/DA converters and data analysis means. page 14, lines 7-9.
The first and second channels are directly connected. See Figures 3-4.
As to claim 56, "Upper body 12" ... "is a service module for rheo-chips to control flow and temperature". Figure 2, 2b, page 15, lines 1-3 of the first full paragraph.
As to claims 57, the temperature control unit and pressure control unit are connected to an automatic controller. See fig. 2, control means 7.
As to claims 59-60, the reference discloses a light source and an image analysis function (program) to determine velocity of the fluid. See page 5, 3rd paragraph, "micro-particle image velocimetry and other rhea-optical measurements".
As to claim 61, the reference discloses calculation of shear stress. See page 16, 4th (next-to-last) paragraph and page 5, 3rd paragraph relates to "micro-particle image velocimetry and other rhea-optical measurements".
As to claim 62, Yuan does not specify that the at least two microfluidic circuits comprise 10 to 12 microfluidic circuits.
The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness.
As to claim 62, it would have been an obvious to and with the common sense, knowledge, and skill of one of ordinary skill in the art before the effective filing date of the invention to manufacture the device of Yuan to comprise 10 to 12 microfluidic circuits as such is an obvious matter of design choice and only requires a duplication of parts, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art.
As to claim 70, Yuan discloses the applied pressure can be constant. (paragraph 0098).
As to claim 71, t would have been an obvious to and with the common sense, knowledge, and skill of one of ordinary skill in the art before the effective filing date of the invention to control the applied pressure as desired to provide for a pressure ramp as desired to control flow within the channels as such would yield predictable results.
As to claim 72-73 it would have been an obvious to and with the common sense, knowledge, and skill of one of ordinary skill in the art before the effective filing date of the invention to include the same or different samples in the channels as desired as such would yield predictable results.
As to claim 74, Yuan discloses a user interface. (Figure 1, control means 7).
Conclusion
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 BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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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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/BRIAN R GORDON/Primary Examiner, Art Unit 1798