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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/23/26 has been entered.
Response to Arguments
Applicant's arguments filed with respect to the rejection of claims under 35 USC 103 have been fully considered but they are not persuasive.
With respect to the “body” of Schmidt, the examiner has clearly interpreted “body” to equate to the fluid passages of Schmidt, the layers 90, 92, 94, and 96. This has been clearly indicated in the marked figure, in the matching limitations, and throughout examiner’s comments. The applicant’s summary on 3 of item matching is correct and agreed upon for the previous actions. (As noted below, because of certain amendments, a reinterpretation of parts of Schmidt is required and will be clearly stated).
The applicant argues at the bottom of page 3 that since the two reaction locations 310 and 314 are within the same transparent channel element 94 they are “coextensive and concurrent, not sequential in the downstream direction”. The examiner is not persuaded. The channel 14 of Schmidt is divided into sequential locations, the first portion, the interrogation zone, and the second portion, subsequentially further broken into an upstream and downstream part. As marked in the figure below, these location in Schmidt are connected and sequential to each other, just as in applicant’s figure 3. The applicant asserts that the detection and interrogation zones are coextensive and concurrent. The examiner disagrees since Schmidt clearly talks about the progression of the sample through “a succession of positions” in the path (Col.5, l 55-58) and how a series of detector cells are positioned in flow direction to subsequently detect an object moving in the channel (Col.5, l 64-67). Schmidt discloses a “series of sensing components, each of which obtains information about object 16 as it travels within a respective straight portion of channel 14” (Col.7, l 41-46). The applicant argues that the reactions and excitation occur “essentially in parallel” with the sensor array, however this is untrue.
However, with respect to the amendments to claim 4, a reinterpretation of certain components of Schmidt are necessary such that the second portion with first and second apertures distinct from the translucent tube so as to permit detection of flow in the second portion by the sensor device without interference from the interrogation zone. Schmidt still discloses these components but elements will be relied upon in Figure 1 as described below in the rejection.
The applicant argues that the sensor of Schmidt is not “external to the body” relying upon confusion of elements to make the point. However, there is no confusion as to elements. The body of Schmidt are the layers of the substrate 80-98 and the sensor itself sits atop these layers, not internal to the layers.
The examiner agrees that the applicant’s invention is different from Schmidt, however it is the claim language that sets the boundaries of an invention and in this case, the claim language does not exclude Schmidt but rather describes it.
The applicant’s arguments are not persuasive.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 4, and 14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The newly added claim amendments: “the sensor device…not fixedly attached to or integrated with the body” and “the upstream and downstream locations…spatially separated from the translucent tube” are not sufficiently supported in the original disclosure.
For “not fixedly attached to or integrated with the body” is a negative claim. Negative limitations must have a clear basis in the original specification and not be a mere absence of positive recitation. There is no disclosure that describes the sensor as not fixedly attached or integrated with the body. The specification only discloses that the sensor device is external to the cell. There is no further detail about what that means.
With respect to “the upstream and downstream locations …spatially separated from the translucent tube” is not supported either. There is no recitation at all regarding this limitation. Figure 3 discloses the upstream and downstream locations located alongside the translucent tube. There is no support for the new limitation.
For these reasons, the claims are rejected for lack of written description.
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) 1, 2, 4, 12, 14, and 15, are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt et al. U.S. Patent #7,547,904 in view of Hong U.S. Patent #7,830,503.
With respect to claim 1, Schmidt discloses a flow cell comprising:
A sensor device (Figure 14, sensor device = ICs 66, 68, and 70)
A body having at least one channel disposed therein, the channel configured to permit fluid flow therethrough, the at least one channel comprising first and second portions (Figure 1, body = flow channels and substrates, layers 80-98 in Figure 2 and 14, channel = 14, Col.5, l 10-14, first portion = area before interrogation zone 56, second portion = area after interrogation zone 56)
A portion of the channel coupling the first portion to the second portion, the channel defining an interrogation zone and being positioned to permit interrogation of the channel by the sensor device external to the body of particles carried by a fluid passing through the channel, the sensor device being external to the body and not fixedly attached to or integrated with the body; wherein the first portion of the channel is upstream of the interrogation zone and the second portion of the channel is downstream of and distinct from the interrogation zone (Figure 14 wherein body = substrate as defined above layers 80-98 in Figure 2 and 14, channel = 14, a portion of the channel = interrogation zone = area 56, Col.12, l 44-48, wherein sensor is external to the body as described above, separated by spacers 292, first portion = area before interrogation zone 56, second portion = area after interrogation zone 56)
The body further comprising an entry aperture fluidly coupling the at least one channel to ambient and configured to receive the fluid into the at least one channel (Figure 14, Figure 1, entry aperture = apertures 20 and 24, channel 14 coupled to external at inputs 20 and 24)
First and second optical elements and within the second portion of the channel, disposed within the body, the first elements positioned to permit detection of flow of the fluid at an upstream location of a second portion of the at least one channel, the second element positioned to permit detection of flow of the fluid at a downstream location of the second portion of the at least one channel, the upstream and downstream locations being both downstream of and spatially separated from the interrogation location in the channel wherein the fluid flows through the first portion through the translucent tube and into the second portion before reaching the first and second optical elements (Figure 14, first optical element = transparent area under sensor 68, Col.12, l 23-26, second optical element = transparent area under 70, Col.13, l 63-Col.14, l 2, body = layers 80-98, interrogation location = channel 14 section under 56 as in Figure 1, Col.9, l 16-19, Col.10, l 45-50)
However, Schmidt fails to disclose a translucent tube at least partially enclosed within the body. Schmidt simply discloses the fluid passing through the etched channel in the substrate.
Hong U.S. Patent #7,830,503 discloses a flow through cell comprising:
A translucent tube at least partially enclosed within the body and coupling the first portion to the second portion (Figure 3, body = base 3, wherein base 3 has an etched channel, and tube = 1, Col.3, l 61- Col.4, l 3)
It would have been obvious to one of ordinary skill in the art at the time of the invention to include a translucent tube within a channel as in Hong for the channel for the channel of Schmidt since Hong discloses using the transparent tube solves leakage and dead angle problems as well as minimizing the creation of micro-bubbles. Both Hong and Schmidt are interested in optically measuring flowing fluid through a snaking pathway. But using the tube of Hong within the snaking pathway of Schmidt, the inner pathway is ensured to be smooth so microbubbles are not detained and the turns contain no dead angle exiting. (Col.2 of Hong).
With respect to claims 2, , Schmidt in view of Hong discloses all of the limitations as applied to claim 1 above. In addition, Schmidt discloses:
A suction aperture disposed at an end of the at least one channel opposite the entry aperture, the suction aperture fluidly coupling the at least one channel to ambient (Col.6, l 50-65, wherein the suction aperture = flush and initial fluid loading functions with pressure, outlet 34)
With respect to claim 4, Schmidt in view of Hong discloses all of the limitations as applied to claim 1 above. In addition, Schmidt discloses:
The first and second optical elements are light-transmissive, positioned in fluid communication with the fluid, and respectively positioned in the first and second sensor apertures so as to permit detection of flow in the second portion by the sensor device without interference from the interrogation zone (where first and second optical elements are light transmissive = Col.13, l 62-66, Col.22, l 21-23, first optical element = transparent area under sensor 68, Col.12, l 23-26, second optical element = transparent area under 70, Col.13, l 63-Col.14).
However, Schmidt and Hong fail to disclose the first and second optical elements are positioned in first and second sensor apertures.
It would have been obvious to one of ordinary skill in the art at the time of the invention to include apertures that define a viewing field along the optical elements of Schmidt. Rather than having a single transparent optical element as in Schmidt, having an opaque element with apertures for transparent elements within it would result in minimizing noise and increasing sensitivity. Apertures allow for more predictable location for the sensor to receive light from and minimizes the influence of external light. It has been held that integrating and separating known components is within ordinary skill in the art. In re Larson 340 F.2d 965 144 USPQ 437 and Nerwin v Erlichman, 168 USPQ 177, 179.
With respect to claim 12, Schmidt discloses a flow cell comprising:
A sensor device (Figure 14, sensor device 290)
A body having at least one channel disposed therein, the channel configured to permit fluid flow therethrough, the at least one channel comprising first and second portions (Figure 1, body = flow channels and substrates, layers 80-98 in Figure 2 and 14, channel = 14, Col.5, l 10-14, first and second portions of channel shown in figure below)
A portion of the channel coupling the first portion to the second portion, the channel being positioned to permit interrogation of the channel by the sensor device external to the body of particles carried by a fluid passing through the channel, the sensor device being external to the body (Figure 14 wherein body = substrate as defined above layers 80-98 in Figure 2 and 14, channel = 14, a portion of the channel = marked in figure below as translucent tube, under sensor 290 sensor device = 290, Col.12, l 44-48, wherein sensor is external to the body as described above, separated by spacers 292, first portion and second portion defined as in figure below)
The body further comprising an entry aperture fluidly coupling the at least one channel to ambient and configured to receive the fluid into the at least one channel (Figure 14, Figure 1, entry aperture = apertures 20 and 24, channel 14 coupled to external at inputs 20 and 24)
First and second optical elements, disposed within the body, the first elements positioned to permit detection of flow of the fluid at an upstream location of a second portion of the at least one channel, the second element positioned to permit detection of flow of the fluid at a downstream location of the second portion of the at least one channel, the upstream and downstream locations being both downstream of the interrogation location in the channel (Figure 14, first optical element = transparent area of 94 where reaction labeled 310 as in figure marked up below, second optical element = transparent area of 94 where reaction labeled 314 as marked in figure below, body = 10, interrogation location = channel 14 section under 58 as in Figure 14, Col.9, l 16-19, Col.10, l 45-50)
The sensor device is configured to be connected to the body such that the body is removably insertable onto the sensor device and the body is received alongside the sensor device, the sensor device surrounds at least a portion of the body to shield the translucent tube from ambient light (Figure 10, step 252 wherein the fluidic structure = body, fluidic components =detector/sensors, Col.20, l 23-30, Col.12, l 44-67, Figure 2, )
However, Schmidt fails to disclose a translucent tube at least partially enclosed within the body and that the sensor device is configured to receive the body therein. Schmidt simply discloses the fluid passing through the etched channel in the substrate and connecting the body and the device together.
Hong U.S. Patent #7,830,503 discloses a flow through cell comprising:
A translucent tube at least partially enclosed within the body and coupling the first portion to the second portion (Figure 3, body = base 3, wherein base 3 has an etched channel, and tube = 1, Col.3, l 61- Col.4, l 3)
It would have been obvious to one of ordinary skill in the art at the time of the invention to include a translucent tube within a channel as in Hong for the channel for the channel of Schmidt since Hong discloses using the transparent tube solves leakage and dead angle problems as well as minimizing the creation of micro-bubbles. Both Hong and Schmidt are interested in optically measuring flowing fluid through a snaking pathway. But using the tube of Hong within the snaking pathway of Schmidt, the inner pathway is ensured to be smooth so microbubbles are not detained and the turns contain no dead angle exiting. (Col.2 of Hong).
Additionally, it would have been obvious to one of ordinary skill in the art at the time of the invention to receive the body into the sensor device rather than generically attached together. Having a housing of the sensor device that encloses the body prevents external light and minimizes noise to that causes errors in the measurement, well-recognized benefits in the art.
With respect to claim 14, Schmidt discloses a flow cell comprising:
A body having at least one channel disposed therein, the channel configured to permit fluid flow therethrough, the at least one channel comprising first and second portions (Figure 1, body = flow channels and substrates, layers 80-98 in Figure 2 and 14, channel = 14, Col.5, l 10-14, first and second portions of channel shown in figure below)
A portion of the channel coupling the first portion to the second portion, the channel being positioned to permit interrogation of the channel by the sensor device of particles carried by a fluid passing through the tube, the sensor device being external to the body of particles carried by a fluid passing through the channel, the sensor device being external to the body and not fixedly attached to or integrated with the body (Figure 14 wherein body = substrate as defined above layers 80-98 in Figure 2 and 14, channel = 14, a portion of the channel = marked in figure below as translucent tube, under sensor 290 sensor device = 290, Col.12, l 44-48, wherein sensor is external to the body as described above, separated by spacers 292 not integrated with body, first portion = area before interrogation zone 56, second portion = area after interrogation zone 56)
First and second optical elements, disposed within the body, the first elements positioned to permit detection of flow of the fluid at an upstream location of a second portion of the at least one channel, the second element positioned to permit detection of flow of the fluid at a downstream location of the second portion of the at least one channel, the upstream and downstream locations being both downstream of and spatially separated from the channel, wherein the fluid flows from the first portion through the translucent tube and into the second portion before reaching the first and second optical elements (Figure 14, first optical element = transparent area under sensor 68, Col.12, l 23-26, second optical element = transparent area under 70, Col.13, l 63-Col.14, l 2, body = layers 80-98, interrogation location = channel 14 section under 56 as in Figure 1, Col.9, l 16-19, Col.10, l 45-50)
However, Schmidt fails to disclose a translucent tube at least partially enclosed within the body. Schmidt simply discloses the fluid passing through the etched channel in the substrate.
Hong U.S. Patent #7,830,503 discloses a flow through cell comprising:
A translucent tube at least partially enclosed within the body and coupling the first portion to the second portion (Figure 3, body = base 3, wherein base 3 has an etched channel, and tube = 1, Col.3, l 61- Col.4, l 3)
It would have been obvious to one of ordinary skill in the art at the time of the invention to include a translucent tube within a channel as in Hong for the channel for the channel of Schmidt since Hong discloses using the transparent tube solves leakage and dead angle problems as well as minimizing the creation of micro-bubbles. Both Hong and Schmidt are interested in optically measuring flowing fluid through a snaking pathway. But using the tube of Hong within the snaking pathway of Schmidt, the inner pathway is ensured to be smooth so microbubbles are not detained and the turns contain no dead angle exiting. (Col.2 of Hong).
With respect to claim 15, Schmidt discloses a method for analyzing particles in a fluid comprising:
Flowing a fluid through a first portion of a channel disposed within a body (Figure 1, first portion = area before zone labeled 56, body = layers 90-98, channel = 14, Col.6, l 1-20)
Passing the fluid from the first portion through a channel at least partially enclosed in the body (Figure 1, channel = sensing area 56, channel = 14, body = layers 90-98, Figure 2, Col.6, l 1-20, Col.10, l 51-57)
The channel defining an interrogation zone within the body (Figure 1, sensing area 56 = interrogation zone)
Interrogating particles in the fluid within the channel using a sensor device external to the body (Figure 1, sensor device external to body = IC 68, Figure 2 shows sensor 87 apart from=external to the body, Col.7, l 41-43, Col.8, l 32-36)
Flowing the fluid from the channel into a second portion of the channel downstream of and distinct from the interrogation zone (Figure 1, second portion = everywhere downstream of interrogation zone 56,
Detecting flow of the fluid at a first location within the second portion using a first optical element disposed within the body (Figure 1, first optical element = suitable optical elements, Col.12, l 23-25, Col.9, l 17-34)
And detecting flow of the fluid at a second location within the second portion downstream of the first location using a second optical element disposed within the body (Col.12, l 62-64, glass = second optical element, Col.9, l 17-34)
However, Schmidt fails to disclose a translucent tube at least partially enclosed within the body. Schmidt simply discloses the fluid passing through the etched channel in the substrate.
Hong U.S. Patent #7,830,503 discloses a flow through cell comprising:
A translucent tube at least partially enclosed within the body and coupling the first portion to the second portion (Figure 3, body = base 3, wherein base 3 has an etched channel, and tube = 1, Col.3, l 61- Col.4, l 3)
It would have been obvious to one of ordinary skill in the art at the time of the invention to include a translucent tube within a channel as in Hong for the channel for the channel of Schmidt since Hong discloses using the transparent tube solves leakage and dead angle problems as well as minimizing the creation of micro-bubbles. Both Hong and Schmidt are interested in optically measuring flowing fluid through a snaking pathway. But using the tube of Hong within the snaking pathway of Schmidt, the inner pathway is ensured to be smooth so microbubbles are not detained and the turns contain no dead angle exiting. (Col.2 of Hong).
Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA CAROLE BRYANT whose telephone number is (571)272-9787. The examiner can normally be reached M-F, 12-4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kara Geisel can be reached at 571-272-2416. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA C BRYANT/ Primary Examiner, Art Unit 2877
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