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 .
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 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.
Claims 1-5, 7-8, 11-17, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hatamian (US 2018/0303390).
Regarding Claim 1, Hatamian discloses a fluid analysis system for analyzing and controlling fluid transfer, the fluid analysis system comprising:
- a controller (Fig 11 and at least para 114, controller 520) communicatively coupled to an optical device (optical measurement element 610 comprises "an absorber 1120");
- a light source (emitter 1110) disposed adjacent the optical device, the light source (1110) being configured to produce light in a viewing zone of the optical device (see Fig 11, Examiner's annotations), such that the optical device can capture the light produced by the light source (disclosed at paras 114-116); and
- a fluid channel (fluid path 1140) disposed adjacent the optical device (1120) and within the viewing zone of the optical device, the fluid channel being configured to provide a fluid flow path (para 114);
- wherein the controller is configured to store and analyze images provided by the optical device to identify characteristics of a fluid flowing through the fluid channel.
Per at least para 97, "the processor 520 may receive and analyze data from the optical measurement elements 610-615. The processor 520 may have an associated memory (not shown)." Hatamian additionally discloses camera 1250 as a component of absorber 1120 (see para 121). Per Hatamian, paras 126, 168, and Fig 5, said camera passes images to UI module 550, also controlled by controller 520.
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Regarding Claim 2, Hatamian discloses a fluid analysis system for analyzing and controlling fluid transfer, wherein the fluid flows from a fluid source (Fig 11, Examiner's annotations) through a tube (Examiner's annotations) to the fluid channel (via forward flow direction 1150, see para 114).
Regarding Claim 3, Hatamian discloses a fluid analysis system for analyzing and controlling fluid transfer, wherein the fluid source is one or more of a cartridge (para 9: "The sample may be collected via a receptacle (e.g., a recess in a surface of the cartridge) using a pump, valve, fluid sensing chip, tubing or other flow pathways, storage cavities, and/or other appropriate feature"), a tube, a bag, and a syringe.
Hatamain additionally makes several references to analyzing samples provided in cartridges throughout the disclosure, see at least para 88 and Fig 6.
Regarding Claim 4, Hatamian discloses a fluid analysis system for analyzing and controlling fluid transfer, wherein the fluid channel extends through a cartridge (sample collection element 605, disclosed as part of "the disposable cartridge" per para 88 and Fig 6) disposed adjacent the optical device and within the viewing zone of the optical device. See Fig 6.
Regarding Claim 5, Hatamian discloses a fluid analysis system for analyzing and controlling fluid transfer, wherein the light source (1110) is configured to produce light that illuminates the fluid channel (para 114).
Regarding Claim 7, Hatamian discloses a fluid analysis system for analyzing and controlling fluid transfer, wherein the controller comprises a field programmable gate array (FPGA), a memory, and an input-output device (para 200), wherein the controller is configured to receive images from the optical device, store the images in the memory, and analyze the images stored in the memory using the field programmable gate array (See Examiner's rejection of Claim 1 above, and paras 97, 126, 128, and Fig 5).
Regarding Claim 8, Hatamian discloses a fluid analysis system for analyzing and controlling fluid transfer, wherein the field programmable gate array analyzing the images comprises: detecting or identifying inner and outer edges of the fluid channel and detecting or identifying a forwardmost fluid edge of the fluid flowing through the fluid channel. See para 160.
Regarding Claim 11, Hatamian discloses a method of using a fluid analysis system to monitor and control fluid transfer (through the normal operation of the apparatus as described in the rejection of Claim 1 above), the method comprising:
- flowing a fluid from a fluid source through a fluid channel (see the rejection of Claim 1 above, and Fig 11, Examiner's annotations, and item 1140);
- capturing, by an optical device (1120), images of the fluid channel and the fluid flowing through the fluid channel (1140); and
- storing and analyzing, by a controller (520), the images to identify characteristics of the fluid flowing through the fluid channel (paras 114-116).
Regarding Claim 12, Hatamian discloses a method of using a fluid analysis system to monitor and control fluid transfer, wherein the characteristics of the fluid flowing through the fluid channel include one or more of a flow rate of the fluid, a forwardmost fluid edge of the fluid (para 160), and the type of fluid.
Regarding Claim 13, Hatamian discloses a method of using a fluid analysis system to monitor and control fluid transfer, further comprising producing, by a light source (1110), light that illuminates the fluid channel (1140) and the fluid flowing through the fluid channel.
Regarding Claim 14, Hatamian discloses a method of using a fluid analysis system to monitor and control fluid transfer, further comprising capturing, by the optical device (1120), the light produced by the light source (Fig 11 and paras 114-116).
Regarding Claim 15, Hatamian discloses a method of using a fluid analysis system to monitor and control fluid transfer, further comprising storing the images produced by the optical device within a memory of the controller (see Examiner's rejections of Claims 1 and 11 above, and paras 97, 126, 128, and Fig 5).
Regarding Claim 16, Hatamian discloses a method of using a fluid analysis system to monitor and control fluid transfer, further comprising analyzing, by a field programmable gate array (FPGA) of the controller, the images stored within the memory of the controller (see Examiner's rejections of Claims 1 and 11 above, and paras 97, 126, 128, 200, and Fig 5).
Regarding Claim 17, Hatamian discloses a method of using a fluid analysis system to monitor and control fluid transfer, wherein the field programmable gate array analyzing the images comprises: detecting or identifying, by the field programmable gate array, an inner edge and an outer edge of the fluid channel; and detecting or identifying, by the field programmable gate array, a forwardmost fluid edge of the fluid flowing through the fluid channel. (see Examiner's rejections of Claims 1 and 11 above, and paras 97, 126, 128, 200, and Fig 5).
Regarding Claim 19, Hatamian discloses a method of using a fluid analysis system to monitor and control fluid transfer, further comprising graphically enhancing, by the field programmable gate array, the detected inner edge and outer edge of the fluid channel graphically enhancing, by the field programmable gate array, the detected forwardmost fluid edge of the fluid flowing through the fluid channel.
See Examiner's rejections of Claims 1 and 11 above, and paras 97, 126, 128, 200, and Fig 5. Additionally:
- Para 96 discloses the use of cameras with "high definition, 4K, and/or other appropriate formats of any resolution", and " Higher resolutions may provide more image processing capability if needed".
- Para 97 states "The processor 520 may be an electronic device capable of executing instructions and/or processing data."
- Para 200 states: "When these instructions are executed by one or more computational element(s) (e.g., microprocessors, microcontrollers, digital signal processors (DSPs), application-specific integrated circuits (ASICs), field programmable gate arrays (FPGAs)) the instructions cause the computational element(s) to perform actions specified in the instructions.".
Examiner broadly interprets these teachings as reading upon the above claim limitations.
Further regarding Claim 19, Hatamian additionally discloses a method of using a fluid analysis system to monitor and control fluid transfer, further comprising outputting, by an input-output device of the controller, an enhanced image graphically illustrating the inner edge of the fluid channel, the outer edge of the fluid channel, and the forwardmost fluid edge of the fluid flowing through the fluid channel.
- Para 121 teaches UI interface 1260 as part of absorber 1120. Per para 126, " The UI interface 1260 may receive captured data from the camera 1250 and provide the data to a resource such as UI module 550. The camera 1250 and UI interface 1260 may allow a patient or practitioner to monitor sample flow during a test."
This teaching, along with the previously noted FPGA teaching of para 200, is broadly interpreted as reading upon this claim limitation.
Claim Rejections - 35 USC § 103
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 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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 6, 9, 10, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hatamian, in view of Cowan et al. (US 20210/170113).
Regarding Claim 6, Hatamian teaches the claimed invention, to include a light source 1110. Hatamian does not discuss the type of light used, so does not explicitly state that “the light produced by the light source is polarized light of any wavelength.”
However, the use of polarized light is well known, as evidenced by Cowan et al. who teaches the light produced by the light source is polarized light of any wavelength. See para 129: "the electromagnetic radiation source 112 can be configured to emit polarized light or certain wavelengths of filtered light, which can be more easily distinguished from ambient light".
The Hatamian and Cowen references each teach analysis of fluid specimens via optical sensing means. Cowen et al. additionally teaches the use of polarized light as an enhanced approach to more easily detect objects. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to ensure that the light emitter 1110 of Hatamian uses polarized light, as taught by Cowen et al., in order to gain the advantages of easier detection of objects.
Regarding Claims 9, 10, and 20, Hatamian teaches the claimed reference to include a fluid analysis system (see the rejection of Claims 1 and 11 above). However, Hatamian is silent on the use of the disclosed invention to “transfer fluids” (as claimed by Applicant at Claims 9 and 20), and doesn’t identify the fluid as one of “a liquid nutrient, liquid medication, or liquid pain reliever” (as claimed by Applicant at Claims 10 and 20).
Further regarding Claims 9 and 20, therefore, Hatamian does not explicitly state that the disclosed fluid analysis system is configured to control fluid transfer in a medical fluid transfer system, as claimed at Claims 9 and 20. However, Examiner notes the following:
Applicant’s disclosure teaches controller 12, and states the claimed limitation of “the fluid analysis system is configured to analyze and control fluid transfer in a medical fluid transfer system” (See paras 12 and 38). However, the disclosure does not provide any guidance on the actual controlling of the transfer of fluid, interpreted by Examiner as at least starting/stopping fluid flow and/or adjusting fluid flow rate. Instead, the disclosure is solely drawn to the controller 12 receiving and storing images of fluid position within the fluid channel 20 of cartridge 18, by “controlling” optical device 14, and light source 16. The disclosure does not teach any mechanism, such as pumps or valves, that are capable of actually controlling the flow of fluid. Additionally, although the disclosure teaches the monitoring and or calculation of fluid flow rate, there is no mention of any component that actually modifies a fluid flow rate.
The Hatamian reference teaches the same aspects of Applicant’s disclosure, namely the control of a light source to determine the position of a fluid within a cartridge, and the subsequent ability to store and interact with the resulting images of said fluid. Examiner therefore asserts that the Hatamian reference teaches “the fluid analysis system is configured to analyze and control fluid transfer in a medical fluid transfer system” of Claims 9 and 20, in a manner similar to that as claimed by Applicant.
Should Applicant traverse the above finding, and in the interests of compact prosecution, Examiner further relies on Cowan et al., who (more explicitly) teaches a fluid analysis system configured to analyze and control fluid transfer in a medical fluid transfer system.
Specifically, Cowan et al. teaches analysis such as edge detection at least at para 182. The reference additionally teaches "Fluid flow from the at least one syringe may be regulated by a fluid control module operated by a controller, such as a detachable touch screen controller 82 or any suitable device" at least at para 258. Therefore, Cowan et al. teaches the above limitations of Claims 9 and 20.
Further regarding Claims 10 and 20, with regard to the type of fluid, as claimed at Claims 10 and 20, Applicant is advised that a claim is only limited by positively recited elements. Thus, inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims. See MPEP 2115.
Regardless, Cowan et al. teaches applicability for saline solution, which would be a "liquid medication" and therefore teaches these limitations of Claims 10 and 20.
The Hatamian and Cowen references each teach analysis of fluid specimens within cartridges via optical sensing means (Cowen teaches a “cartridge” in the form of a syringe; Examiner broadly interprets these storing items as being equivalent). The Cowen reference additionally teaches utility for controlling/regulating fluid transfer for medical purposes. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to combine the cartridge of the Hatamian reference (which includes optical sensing components for liquid edge position measurements) with the fluid flow control mechanisms as taught by Cowen et al., in order to gain the advantages of using liquid edge measurements to regulate fluid transfer and flow.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Hatamian, in view of Tokunaga (WO 2005093483 A1).
Regarding Claim 18, Hatamian teaches the claimed invention, to include the use of a field programmable gate array to detected the fluid edge (see the rejections of Claims 1 and 11 above, and para 160). Hatamian additionally discloses (para 96) a camera 570 with “high definition, 4K, and/or other appropriate formats of any resolution,” and additionally states “Higher resolutions may provide more image processing capability if needed.”
Hatamian doesn’t explicitly recite the degree of accuracy of the fluid analysis system, and therefore does not explicitly recite the field programmable gate array detects or identifies the forwardmost fluid edge of the fluid flowing through the fluid channel to within 20 micrometers, as claimed by Applicant. However, Examiner notes that Applicant’s disclosure merely states this claimed limitation verbatim, and offers no discussion on how “within 20 micrometers” is achieved, what components are necessary to achieve this level of accuracy, or why this level of accuracy (or the components used) would be novel over the state of the art or otherwise unexpected. Examiner concludes that one of ordinary skill in the art would be motivated to use the most accurate measuring tool(s) available for the obvious result of utilizing more accurate measurements for other, follow-on operations, and doing so would be a matter of routine optimization. In the present case, one of ordinary skill in the art would have a reasonable expectation of success by using the most accurate tool(s) available.
Regardless, and in the interests of compact prosecution, Examiner additionally relies on Tokunaga, who teaches the ability of the prior art to “to obtain an accuracy on the order of a micrometer” for measured samples. Please see “Description”, fourth paragraph.
Hatamian and Tokunaga each teach the use of optical equipment to measure the position of samples. The Tokunaga additionally teaches it is known to the prior art to achieve and accuracy “on the order of a micrometer” for measured samples. It would have been obvious to one of ordinary skill in the art to utilize the further teachings of Tokunaga, to include use of the necessary tools to reach this level of accuracy and program the field programmable gate array of Hatamian to use these tools, in order to reach an accuracy of within a micrometer.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20130336814 additionally teaches the limitations of at least the independent claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER M AFFUL whose telephone number is (571)272-8421. The examiner can normally be reached Monday - Thursday: 7:30 AM - 5:00 PM Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Craig Schneider can be reached at 5712723607. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER M AFFUL/Primary Examiner, Art Unit 3753