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 .
Election/Restrictions
Applicant’s election without traverse of Group II (claims 26-32) and Species 13 (claim 30) in the reply filed on 04/03/2026 is acknowledged.
Claims 26-30 are being examined.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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:
a module configured to perform a function on an item in the module; a plurality of sensors, each of the plurality of sensors configured to monitor the function or the item and generate sensor data in response to monitoring; and a computer configured to: check an operational status of a first sensor; receive sensor data from at least one of the plurality of sensors; and scale sensor data generated by the first sensor in response to the operational status and the sensor data to generate revised sensor data in claim 26.
the computer is further configured to impute sensor data of the first sensor in response to the operational status and the sensor data in claim 27.
at least one of the plurality of sensors is a pressure sensor configured to measure pressure of a liquid during an aspiration process or a dispense process in claim 28.
at least one of the plurality of sensors is an imaging device configured to capture an image of the item, the image comprising image data in claim 29.
the computer is configured to receive user input, and wherein the computer is configured to scale the sensor data in response to the user input in claim 30.
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.
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 26-30 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 26-30 are not clear with respect to what applicant is claiming. The claims do not clearly set forth the metes and bounds of the patent protection desired. Claims 26-30 are unclear what structural configurations are being claimed. For example, claim 26 is unclear reciting “a module configured to perform a function on an item in the module; a plurality of sensors, each of the plurality of sensors configured to monitor the function or the item and generate sensor data in response to monitoring; and a computer configured to: check an operational status of a first sensor; receive sensor data from at least one of the plurality of sensors; and scale sensor data generated by the first sensor in response to the operational status and the sensor data to generate revised sensor data” because it is unclear whether the limitation(s) following the phrase “configured to” are part of the claimed invention as they include elements that have not been positively claimed (i.e., an item in the module, sensor data, a first sensor, etc.). Claim 26 is further unclear reciting “a plurality of sensors [...] a first sensor” because it is unclear whether the first sensor is part of the plurality of sensors. For the reasons above, claims 27-30 are similarly unclear.
Claim 26 recites the limitation "the function or the item" in L5. There is insufficient antecedent basis for this limitation in the claim.
Claim 27 recites the limitation "sensor data" in L2. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "at least one of the plurality of sensors" in L1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation "at least one of the plurality of sensors" in L1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 30 is unclear reciting "the sensor data" in L3 because it is unclear which sensor data the limitation is referring to (the sensor data from: each of the plurality of sensors, the at least one of the plurality of sensors, or the first sensor).
Claim limitation ‘configured to [...]’ has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the term “means” or generic placeholder is modified by a word, which is ambiguous regarding whether it conveys structure or function; and/or the claim limitation uses the word “means” or a generic placeholder coupled with functional language, but it is modified by some structure or material that is ambiguous regarding whether that structure or material is sufficient for performing the claimed function. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
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 (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 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.
Claim(s) 26-30 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Holmes (US 2014/0170735 A1).
Regarding claim 26, Holmes teaches:
26. A diagnostic laboratory system (systems of sample collection, sample preparation, assay, and/or detection for accurate diagnoses, ongoing monitoring, and guidance of treatment; Fig. 3; ¶ 0007), comprising:
a module capable of performing a function on an item in the module (see i.e., Devices may comprise one or more module. A module may be capable of performing one or more, two or more, or all three of a sample preparation step, assay step, and/or detection step. FIG. 3 shows an example of a module 300. A module may comprise one or more, two or more, or three or more of a sample preparation station 310, and/or an assay station 320, and/or a detection station 330. In some embodiments, multiple of a sample preparation station, assay station, and/or detection station are provided. A module may also include a fluid handling system 340. ¶ 0479);
a plurality of sensors, each of the plurality of sensors capable of monitoring the function on the item and generate sensor data in response to monitoring (see i.e., A module (300) may include one or more detection stations (330). A detection station may include one or more sensors that may detect visual/optical signals, infra-red signals, heat/temperature signals, ultraviolet signals, any signal along an electromagnetic spectra, electric signals, chemical signals, audio signals, pressure signals, motion signals, or any other type of detectable signals. The sensors provided herein may or may not include any of the other sensors described elsewhere herein. [...] A detection station may contain, for example, a spectrophotometer, a PMT, a photodiode, a camera, an imaging device, a CCD or CMOS optical sensor, or a non-optical sensor. In some embodiments, a detection station may contain a light source and optical sensor. In some embodiments, a detection station may contain a microscope objective and an imaging device. ¶ 0489); and
a computer capable of :
checking an operational status of a first sensor (see i.e., a controller determines a current device state by using a first sensor feedback in trying to correct a detected error or malfunction ¶ 1390);
receiving sensor data from at least one of the plurality of sensors (see i.e., the controller receives data collections from a plurality of sensors of the detection units of the detection station ¶ 1390); and
scaling sensor data generated by the first sensor in response to the operational status and the sensor data to generate revised sensor data (see i.e., the controller processes sensor signals in a mutually-dependent manner interpreting sensor signals from multiple types of sensors or detection units for verification or as a coarse first measurement which is then used to refine a second measurement, and therefore refines for generating revised sensor data, Fig. 3, ¶ 1391, 1392, 1412, 1413).
Regarding claims 27-30, Holmes teaches:
27. The diagnostic laboratory system of claim 26, wherein the computer is further capable of imputing sensor data of the first sensor in response to the operational status and the sensor data (see i.e., the controller processes sensor signals in a mutually-dependent manner interpreting sensor signals from multiple types of sensors and thus imputes the dynamic resource allocation based on real-time feedback when a resource is functionally unavailable, Fig. 3, ¶ 1391, 1392, 1412, 1413).
28. The diagnostic laboratory system of claim 26, wherein at least one of the plurality of sensors is a pressure sensor capable of measuring pressure of a liquid during an aspiration process or a dispense process (see i.e., one or more sensors provide pressure data to a control system and based on the signals from sensors, the controller dispenses and/or aspirates a sample, ¶ 0852, 1390).
29. The diagnostic laboratory system of claim 26, wherein at least one of the plurality of sensors is an imaging device capable of capturing an image of the item, the image comprising image data (see i.e., module 300 includes an assay station 320 comprising a cytometer, and a detection station 330 comprising a camera, an imaging device, a CCD, or a CMOS optical sensor, for digital imaging comprising collections of images or video, each outputting image data, ¶ 0479, 0482, 0489, 1372).
30. The diagnostic laboratory system of claim 26, wherein the computer is capable of receiving user input, and wherein the computer is capable of scaling the sensor data in response to the user input (see i.e., a graphical user interface GUI enables a subject to interact with device, such as operator input to instruct the device to run calibrations, also including a processing protocol adjustable by a user for a particular use, or modified or updated while the protocol is in use, ¶ 1444, 1513, 1557, 1698).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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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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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
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