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 .
Drawings
The drawings were received on May 31, 2023. These drawings are accepted.
Claim Objections
Claim 12 is objected to because of the following informalities: Applicant has recited “the block” in line 6, the term of which has been previously recited to describe the shape of the chip. Applicant should consider the use of consistent terminology when referring to claimed embodiments; specifically, “the block” should likely recite “the chip” or “the microfluidic sample chip”. Appropriate correction is required.
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 16 and 18 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.
Claim 16 recites the limitation "the tap of the chip" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the transparent block" in line 5. There is insufficient antecedent basis for this limitation in the claim.
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 (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 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 12-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nakao (US 2011/0285990 A1) (provided by applicant in IDS dated 5/31/2023) in view of Huff et al (US 2018/0126381 A1).
With respect to claim 12 Nakao discloses a system to test a microfluidic sample chip to perform a polymerase chain reaction (PCR) type testing of biological samples, the chip having a shape of a block, said chip comprising at least one hollow chamber to receive a sample, delimited by a first wall made out of a high thermal conductivity material, a material with a thermal conductivity greater than 15Wm'K-, and a second wall made at least partially out of a transparent material, the block comprising at least two first openings to allow introduction of the sample into said at least one hollow chamber and evacuation of the atmosphere in said at least one hollow chamber during the introduction of the sample, the first wall and the second wall being parallel to each other, the chip comprising a tab arranged in an extension of the first and second walls, and a sealing device, arranged in contact with the second wall, the system (analysis tool 10) comprising:
a side wall (upper surface 11) provided with a second opening (attachment section 12) to allow a passage of the chip towards a thermalization element (bottom surface 20 of counterbore section 19; main body of analysis tool 10 receives heat from heat block 50 by bottom surface of the counterbore section and transmits heat to the flow path chip 30 from mount surface 30; See Figs. 3-4 and Paras. 0045-0047);
a complementary polarizing element (concave section 17a) configured to cooperate with a polarizing element on the chip (concave sections 17a, 17b for fixing micro flow path chip 30 by engaging with convex sections 39a, 39b of micro flow path chip 30 (cf. FIG. 5) are formed on left side surface 16 (left end surface in FIG. 4 side; See Para. 0046); and
a transparent element (optically transparent notch section 21; See Para. 0048 for discussion of how notch section 21 is formed to include a part corresponding to an optical path of the light radiated from the lens of optical unit 60 (hereinafter referred to simply as "optical path") L when analysis tool 1 is arranged on heat block 50) configured to maintain the chip in contact with the thermalization element after introduction the chip through the second opening, the contact between the chip and the thermalization element being generated by a cooperation of the polarizing element on the chip and the complementary polarizing element (See Para. 0061 for discussion of how the chip is pressed into the analysis tool 10 and concave section 17a/b and convex section 39a/b are engaged, and then the analysis tool is arranged on a heat block 50).
Applicant should note that the italicized recitations are drawn to the specifics of the microfluidic sample chip. The chip has not been positively recited as feature of the claimed system, but rather, something that the claimed system is intended to act up on. As such, the system taught by the utilized prior art merely needs to be capable of being used with the microfluidic sample chip.
While Nakao does discuss radiating light to the sample from the lens of optical unit 60 and observing fluorescent wavelength of the sample (See Para. 0066), there is no specific discussion of the inclusion of a sensor to measure fluorescence of the sample.
Huff teaches an analyte detection device configured to operate an analyte detection chip to prepare a test sample and to detect an analyte related signal from the prepared test sample in the analyte detection chip is disclosed. The analyte detection region may be configured for detection of a light signal generated when the analyte is present in the sample. The DMF region may be used to transfer a droplet for analysis to a region where the droplet will be analyzed optically or electrically. Optical detection may be colorimetric detection, turbidimetric detection, fluorescent detection, and/or image analysis. Image analysis may include a detection of an optical signal from the analyte detection cartridge. Optical signal may be a light signal, such as a colorimetric, turbidimetric, or fluorescent signal (See Para. 0448). The analyte detection instrument may be configured to include means for detecting an optical signal and an electrical signal. For example, the analyte detection instrument may include imaging sensors such as CMOS, CCD or enhanced CCD (eCCD) camera, PMT, APD. In addition, the analyte detection instrument may include means for sample illumination such as LED, lasers, and the like (See Para. 0502).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the fluorescence-sensing sensor taught by Huff into the system of Nakao to ensure that the system of Nakao is specifically configured with a means of detecting a fluorescent optical signal (See Para. 0502 of Huff).
With respect to claim 13 the combination of Nakao and Huff teaches that the system further comprises a fluorescence imager (See Para. 0066 of Nakao and Paras. 0048 and 0502 of Huff).
With respect to claim 14, applicant should note that the claim is further drawn to the configuration of the chip, not the claimed system. The chip has not been positively recited as feature of the claimed system, but rather, something that the claimed system is intended to act upon. As such, the system taught by the utilized prior art merely needs to be capable of being used with the microfluidic sample chip.
With respect to claim 15, applicant should note that the claim is further drawn to the configuration of the chip (“polarizing element”), not the claimed system. The chip has not been positively recited as feature of the claimed system, but rather, something that the claimed system is intended to act upon. As such, the system taught by the utilized prior art merely needs to be capable of being used with the microfluidic sample chip.
With respect to claim 16, applicant should note that the claim is further drawn to the configuration of the chip (“notch” of the polarizing element), not the claimed system. The chip has not been positively recited as feature of the claimed system, but rather, something that the claimed system is intended to act upon. As such, the system taught by the utilized prior art merely needs to be capable of being used with the microfluidic sample chip.
With respect to claim 17, applicant should note that the claim is further drawn to the configuration of the chip (“hollow chamber” of the chip), not the claimed system. The chip has not been positively recited as feature of the claimed system, but rather, something that the claimed system is intended to act upon. As such, the system taught by the utilized prior art merely needs to be capable of being used with the microfluidic sample chip.
With respect to claim 18, applicant should note that the claim is further drawn to the configuration of the chip (“hollow chamber” of the chip), not the claimed system. The chip has not been positively recited as feature of the claimed system, but rather, something that the claimed system is intended to act upon. As such, the system taught by the utilized prior art merely needs to be capable of being used with the microfluidic sample chip.
With respect to claim 19, applicant should note that the claim is further drawn to the configuration of the chip (“protective film” being placed over the at least two first openings of the chip), not the claimed system. The chip has not been positively recited as feature of the claimed system, but rather, something that the claimed system is intended to act upon. As such, the system taught by the utilized prior art merely needs to be capable of being used with the microfluidic sample chip.
With respect to claim 20, applicant should note that the claim is further drawn to the configuration of the chip (“identification label at the tab” of the chip), not the claimed system. The chip has not been positively recited as feature of the claimed system, but rather, something that the claimed system is intended to act upon. As such, the system taught by the utilized prior art merely needs to be capable of being used with the microfluidic sample chip.
With respect to claim 21, applicant should note that the claim is further drawn to the configuration of the chip (“second wall” of the chip), not the claimed system. The chip has not been positively recited as feature of the claimed system, but rather, something that the claimed system is intended to act upon. As such, the system taught by the utilized prior art merely needs to be capable of being used with the microfluidic sample chip.
With respect to claim 22, applicant should note that the claim is further drawn to the configuration of the chip (“chip comprises at least four chambers”), not the claimed system. The chip has not been positively recited as feature of the claimed system, but rather, something that the claimed system is intended to act upon. As such, the system taught by the utilized prior art merely needs to be capable of being used with the microfluidic sample chip.
With respect to claim 23, applicant should note that the claim is further drawn to the configuration of the chip (“opaque wall is arranged between each of said at least four chambers” of the chip), not the claimed system. The chip has not been positively recited as feature of the claimed system, but rather, something that the claimed system is intended to act upon. As such, the system taught by the utilized prior art merely needs to be capable of being used with the microfluidic sample chip.
With respect to claim 24, applicant should note that the claim is further drawn to the configuration of the chip (shape of the chip), not the claimed system. The chip has not been positively recited as feature of the claimed system, but rather, something that the claimed system is intended to act upon. As such, the system taught by the utilized prior art merely needs to be capable of being used with the microfluidic sample chip.
With respect to claim 25, applicant should note that the claim is further drawn to the configuration of the chip (“first wall” of the chip), not the claimed system. The chip has not been positively recited as feature of the claimed system, but rather, something that the claimed system is intended to act upon. As such, the system taught by the utilized prior art merely needs to be capable of being used with the microfluidic sample chip.
With respect to claim 26, applicant should note that the claim is further drawn to the configuration of the chip (characteristic of the tab of the chip), not the claimed system. The chip has not been positively recited as feature of the claimed system, but rather, something that the claimed system is intended to act upon. As such, the system taught by the utilized prior art merely needs to be capable of being used with the microfluidic sample chip.
With respect to claim 27, applicant should note that the claim is further drawn to the configuration of the chip (composition of the tab of the chip), not the claimed system. The chip has not been positively recited as feature of the claimed system, but rather, something that the claimed system is intended to act upon. As such, the system taught by the utilized prior art merely needs to be capable of being used with the microfluidic sample chip.
With respect to claim 28, applicant should note that the claim is further drawn to the configuration of the chip (composition of the tab of the chip), not the claimed system. The chip has not been positively recited as feature of the claimed system, but rather, something that the claimed system is intended to act upon. As such, the system taught by the utilized prior art merely needs to be capable of being used with the microfluidic sample chip.
With respect to claim 29, applicant should note that the claim is further drawn to the configuration of the chip (orientation of the tab relative to other features of the chip), not the claimed system. The chip has not been positively recited as feature of the claimed system, but rather, something that the claimed system is intended to act upon. As such, the system taught by the utilized prior art merely needs to be capable of being used with the microfluidic sample chip.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITTANY I FISHER whose telephone number is (469)295-9182. The examiner can normally be reached IFP.
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/BRITTANY I FISHER/Examiner, Art Unit 1796 January 8, 2026