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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: an authentication chip adapted to provide authentication of the cartridge, identification of the cartridge, and data storage for the cartridge including providing test configuration parameters and storing test results, as recited in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Terminal Disclaimer
The terminal disclaimer filed on 12/19/25 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Application No. 16/855,709, No. 17/683,924, and No. 17/683,694 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 103
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.
Claims 1-7 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20100248258 (herein after “Lee”) in view of US 20190032114 (hereinafter “Trivedi”) and further in view US 20180011021 (hereinafter “Shoji”), and Buechler (WO 99/35486).
As to claim 1, Lee discloses the limitations as follows:
a cartridge [biochip, see para. 0011 or 0012 in Lee] comprising:
a first chamber configured to receive a test sample [first fluidic channel, para. 0011, 0012, 0040 or claim 14 of Lee, or alternatively, the purification chamber which receives the sample after attachment to the magnetic beads, para. 0040]
the first chamber filled in the cartridge with micromagnetic particles having antigens adapted to bind to antibodies raised against the pathogen immobilized on the micromagnetic particles [see magnetic particles and capture antibody binding the target, para. 0011, 0012, 0013, 0040, or claim 14].
Moreover regarding Applicant’s claim 1, Lee also discloses a first reservoir in the cartridge filled with detecting primary antibodies and secondary antibodies labeled with a fluorescent compound reactive to the presence of the pathogen [see antibody labeled with fluorescent molecule in the mixing chamber or storage chamber, paras. 0011, 0012, 0040, or claim 14] [see especially paragraph 0040 disclosing that if a fluorescent antibody binds to the target, a bound form of magnetic bead-capture antibody-target-fluorescent antibody complex will be formed].
Also regarding Applicant’s claim 1, Lee discloses a detection area. See paragraph 0010 disclosing a fluorescence detection area.
While Lee discloses a cartridge and storage chambers with reagents, Lee is silent as to the storage chambers (reservoirs) being hermetically sealed during manufacture of the cartridge. Since details of sealing the storage chamber of Lee is not given, it is not clear that the storage chambers are hermetically sealed during manufacture.
However, Trivedi teaches providing reagents in sealed blister pouches, which are understood to be hermetically sealed during manufacture. More specifically, Trivedi discloses the following.
Trivedi discloses a test cartridge that includes capping tabs [equivalent to prongs] to provide actuation force to dispense a blister reservoir [to pressurizes the blister within a chamber].
More specifically, Trivedi discloses the following.
“…In some embodiments, a test cartridge is configured to receive one or more test samples. For example, in some embodiments, a test cartridge is configured to receive a bacterial swab and/or a viral swab. In some embodiments, the test cartridge 2600 is configured to receive a single test sample in a sample lysis chamber 202. In some embodiments, chambers 2604 and 2606 contain wash buffers. In some embodiments, chamber 2608 contains elution buffer. In some embodiments, the buffers and solutions in chambers 2602, 2604, 2606, and 2608 may be contained in sealed pouches or blister packs inside the chamber. Additionally, in some embodiments, chamber 2602 may contain dry reagents to promote chemical lysis of target cells in a test sample. In some embodiments, the test cartridge includes capping tabs 2610 and 2612. In some embodiments, capping tabs are configured with puncturing features designed to puncture said pouches or blister packs upon closing the caps, thereby releasing the appropriate fluid in each chamber. In some embodiments, after inputting the sample in sample lysis chamber 2602, a user may seal the chambers using capping tabs 210 and 2612. In some embodiments, the capping tabs may be configured to compress ambient air inside each chamber to pressurize each chamber.” Paragraph 0427 (emphasis added).
Examiner notes that it is understood from paragraph 0427 that the capping tabs pressurize each chamber to release the fluid.
This is also shown in paragraph 0473 which discloses an embodiment in which “[t]he blister pack containing buffer is depressed to release buffer solution into the channels of the cartridge. The buffer solution flows through to the sample collection chamber and mixes with the sample. It may also flow into the hydrophilic filter and continue into the PCR chamber. However, to ensure smooth flow, the blister pack containing air is depressed, thereby pushing the mixed buffer and sample through the hydrophilic filter and into the PCR chamber 1111…” Para. 0473 (emphasis added).
Thus, Trivedi discloses providing blister pack to hold reagents in an assay device for use in an assay. It is understood that the blister packs are hermetically sealed during manufacture [since it is understood that the blister packs hold in the reagents and is provided as such to the user].
Thus Trivedi shows that a hermetically sealed blister containing reagent fluids for testing is known in the art, and its use in the Lee invention would have been obvious given that it would have produced a predictable outcome of providing a means to provide and use reagents for performing an assay. One skilled in the art would have had reasonable expectation of success in providing blister packs in the storage chambers of the Lee biochip since Trivedi teaches that these blister packs can be provided in an assay device (with channels and reaction zones, see para. 0039 and 0473) for containing reagents for use during the assay.
Furthermore, while Lee discloses use of fluorescent labels for detection, Lee does not give further details regarding the fluorescence detection.
Thus, regarding claims 1-3, Lee is silent as to a light source, and optical sensor to detect the fluorescent compound.
However Shoji discloses these limitations for detection of fluorescent labels (see claim 1 of Shoji). It would have been obvious to one skilled in the art to refer to Shoji for the details regarding the fluorescence detection, including providing a light source and optical sensor.
Buechler also suggests a computer that is adapted to provide authentication of the cartridge, identification of the cartridge, and data storage for the cartridge including providing test configuration parameters and storing test results. Examiner notes that Applicant’s specification does not describe what constitutes authentication. Therefore authentication is interpreted to include the disclosures of Buechler as follows.
Buechler recites in claim 1 a fluorometer for sending the fluorescence of a sample, comprising:
an assay device for carrying the sample to be tested;
an optical energy source;
an optical energy detector;
an encoded label disposed on the assay device to provide encoded sample information relating to the sample carried in the assay device…;
a processor for controlling the operation of the test in accordance with test instructions and for processing the emitted energy detected from… the sample to determine test results;
a ROM chip socket for accepting at least one of a plurality of ROM chips, wherein each said ROM chip stores data relating to one or more assays to be performed; and
a communications interface for transferring test information between the fluorometer and an external entity.
These elements are discussed by Buechler in more details as follows.
“The enhanced fluorometer according to the embodiment illustrated in FIG. 1 includes a processor 104, a power supply 108, a user interface 112, a memory 116, a communications interface 120, an assay device 124, a storage device 128, and removable storage media. In the example illustrated in FIG. 1, the removable media include a ROM chip 136 and ROM chip socket 132, and a disk drive 138. Any or all of these functionalities can be included with an enhanced fluorometer depending on the particular application.” Page 8, lines 18-24.
“Processor 104 controls the operation of the fluorometer and also provides control for the various functionalities provided with the fluorometer. Processor 104 can be a central processor that controls the functionality via a bus structure or other communications interface. Alternatively, for example, processor 104 can be implemented by distributing the processing functions among one or more of the various components utilized to implement the functionalities of the fluorometer.” Page 8, lines 25-30. Emphasis added.
Thus Buechler discloses that the processor is adapted to perform the disclosed functions such as functionalities provided to the processor by the ROM chip (see page 8, lines 21-28), which includes “to store operating instructions and to provide memory registers for operating and storage” (page 9, lines 27-28), “to store program instructions, control and calibration curves, operational data, history logs, and other data which may be desired to be stored within the fluorometer” (page 9, lines 27-32), and to contain “program instructions, calibration curves, control data, or other information” (page 10, lines 3-5). Software provided in a ROM Chip, and thus which is provided to the processor for performing the functionalities, include test software and associated calibration and control information, and software for a plurality of tests (page 11, lines 17-19).
Internal data storage can be used to store program instructions (including test instructions), calibration curves, control and calibration data as well as other data used in the operation of the fluorometer. Page 3, line 31-33.
Buechler also discloses that there may be an encoded tag on the assay device, such as a bar code label or magnetic stirp to allow sample, test, or reagent information to be encoded. Sample information can include an identification of the sample and sample type, identification of the patient from which the sample was drawn, an indication of the tests to be performed for the sample. Reagent information can include the type of reagents in a device, lot specific information, such as calibration information and expiration dating. Once a sample is correctly labeled, there is no longer a need for manual user intervention to enter this information. In fully automated embodiments, this information is stored along with test results and other pertinent information to create and maintain an accurate record of the tests and test results. See page 5, line 29 to page 6, line 6.
Examiner notes that the encoded tag discussed above is equivalent to an identifier that provides identification of the assay device (equivalent to the claimed cartridge), and that it is understood that the processor ultimately reads the information on the encoded tag (alternatively, using the processor to read the information would have been obvious to one skilled in the art as is well known in the art). The processor disclosed by Buechler is equivalent to the claimed authentication chip that is adapted to provide authentication of the cartridge [e.g., providing information from the internal data storage disclosed by Buechler discussed above], identification of the cartridge [e.g., providing information from the encoded tag on the assay device disclosed by Buechler discussed above], and data storage for the cartridge including providing test configuration parameters and storing test results [e.g., providing storage of any of the data disclosed on page 5, line 29 to page 6, line 6, such as reagent information, lot specific information, calibration information, etc.]
Thus a processor that is adapted to perform the claimed functions is disclosed by Buechler, and one skilled in the art would have been motivated to provide a processor with such capabilities for the benefits and purposes as disclosed by Buechler. One skilled in the art would have had reasonable expectation of success in providing such a processor in the modified assay system of Lee given that Buechler teaches that such a processor can be provided in an assay system.
Claim 1 further recites: “an authentication chip adapted to provide authentication of the cartridge, identification of the cartridge, and data storage for the cartridge including providing test configuration parameters and storing test results”.
Claim 1 also recites: “an apparatus comprising:
a light source disposed so as to excite the at least one fluorescent compound with a light; and
an optical sensor disposed so as to detect an emitted spectrum of light from the excited at least one fluorescent compound;
wherein the apparatus is configured to read data from the authentication chip upon insertion of the cartridge into the apparatus.
Lee is silent as to the above limitations.
However, Buechler teaches these limitations as follows.
Buechler teaches an energy source such as a laser for illumination of the sample and an energy detector (page 27, lines 3-16).
Buechler teaches that an encoder such as a magnetic strip encoder [equivalent to an authentication chip] encodes information on an assay device [equivalent to a cartridge], such that when the user inserts the assay device into the fluorometer [equivalent to an apparatus as claimed], a reader reads the information on the assay device and combines the assay results with the encoded information. See page 6 of Buechler, at lines 11-19. The encoder encodes information such as patient information, tests to be performed and the like that can be entered through a keypad or computer that downloads the information to the fluorometer (page 6, lines 11-15.)
It would have been obvious to one skilled in the art to provide this mechanism in the Lee invention for the benefits disclosed by Buechler, to read information on the assay device upon insertion into an apparatus such as a fluorometer, as would be desirable for ease of use or for convenience. As taught by Buechler the encoder encodes information such as patient information, tests to be performed and the like (page 6, lines 11-15.) Thus, the encoder of Buechler is equivalent to Applicant’s “authentication chip adapted to provide authentication of the cartridge, identification of the cartridge, and data storage for the cartridge including providing test configuration parameters and storing test results”.
Regarding claims 4-7, use of a plurality of fluorescent compounds with wavelengths ranges that do not overlap would have us to one skilled in the art for distinctly detecting the different fluorescent compounds simultaneously been obvious as suggested by Shoji (see claim 1 of Shoji).
Regarding claim 20, Trivedi teaches that reagents in chambers may be contained in sealed pouches or blister packs inside the chamber (para. 0427), and its use in the Lee invention requires ordinary skills in the art since it merely uses a known element in a familiar manner shown by Trivedi.
Allowable Subject Matter
Claims 8-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
[Examiner also notes that Application 17/683,694 also has similar allowable subject matter.]
The following is a statement of reasons for the indication of allowable subject matter.
It was not found in the prior art search a teaching or suggestion for an apparatus comprising: a loading bay disposed on the apparatus to receive a cartridge; a door disposed on the apparatus to cover the loading bay; at least one blunt prong disposed on an interior of the door to provide actuation force directly from the at least one blunt prong to at least one blister reservoir disposed on the cartridge when the door is closed, so as to dispense the at least one blister reservoir; and a device disposed relative to the cartridge to move contents of the cartridge among chambers of the cartridge.
Regarding claim 8, the previous grounds for rejection using the cited Jina reference [US 20060148096] are withdrawn given that Jina does not disclose an apparatus with chambers (or equivalents such as channels). Therefore, Jina does not teach or fairly suggest an apparatus that has a door with blunt prongs on a door that is capable of depressing blister reservoir(s) to dispense contents of the plurality of blister reservoirs into chambers of a cartridge associated with each blister reservoir. The invention of Jina is a device with a door with blunt prongs to depress a pouch or blister integrated with a test strip. Therefore, Jina does not fairly teach or suggest a device that is capable of depressing a pouch or blister that dispenses contents of blister(s) into chambers of a cartridge.
Moreover, neither the cited references Mototsu [US 20050118061] nor Trivedi [US 20190032114] disclose an apparatus that has blunt prongs on the interior of a door of the apparatus to depress a pouch or blister to dispense contents of the blister(s) into chambers of a cartridge.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
Applicant argues that the computer system of Bevilacqua is fundamentally different from an “authentication chip” (top of page 15 of the response 12/19/25).
Examiner notes that in the present Office action, Bevilacqua has been removed from the grounds for rejection.
As indicated above in the amended grounds for rejection, Buechler teaches that an encoder such as a magnetic strip encoder [equivalent to an authentication chip] encodes information on an assay device [equivalent to a cartridge], such that when the user inserts the assay device into the fluorometer [equivalent to an apparatus as claimed], a reader reads the information on the assay device and combines the assay results with the encoded information. See page 6 of Buechler, at lines 11-19. The encoder encodes information such as patient information, tests to be performed and the like that can be entered through a keypad or computer that downloads the information to the fluorometer (page 6, lines 11-15.)
It would have been obvious to one skilled in the art to provide this mechanism in the Lee invention for the benefits disclosed by Buechler, to read information on the assay device upon insertion into an apparatus such as a fluorometer, as would be desirable for ease of use or for convenience. As taught by Buechler the encoder encodes information such as patient information, tests to be performed and the like (page 6, lines 11-15.) Thus, the encoder of Buechler is equivalent to Applicant’s “authentication chip adapted to provide authentication of the cartridge, identification of the cartridge, and data storage for the cartridge including providing test configuration parameters and storing test results”.
Applicant also argues on page 18 that an “authentication chip” does not include the encoded tag of Buechler. However, Applicant provides no support for this interpretation.
Applicant also argues that Bevilacqua fails to disclosing the recited functions of the authentication chip, such as “providing test configuration parameters”.
However, Examiner notes that the claims recite “an authentication chip adapted to provide authentication of the cartridge, identification of the cartridge, and data storage for the cartridge including providing test configuration parameters and storing test results” (emphasis added). Examiner notes that “adapted to” is interpreted to mean --capable of--.
Buechler teaches that the encoder encodes information such as patient information, tests to be performed and the like that can be entered through a keypad or computer that downloads the information to the fluorometer (page 6, lines 11-15.) Thus, the encoder of Buechler is equivalent to Applicant’s “authentication chip adapted to provide authentication of the cartridge, identification of the cartridge, and data storage for the cartridge including providing test configuration parameters and storing test results”.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/Ann Montgomery/Primary Examiner, Art Unit 1678