The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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), 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):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f), 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f), 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), 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), 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), 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 photodetector configured to be” and “a calculator operatively coupled to the photodetector and configured to” in claim 1.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f), 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), applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) (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).
Examiner makes the following statements with respect to how the language of certain claims has been treated for examination purposes. With respect to claim 1, for examination purposes, examiner will treat the “photodetector configured to be” language as follows: the photodetector includes structure capable of optically coupling the photodetector to the sample measurement container and the standard solution measurement container. Additionally there is sufficient control structure present to control the photodetector to detect the stated first and second luminescence of a sample stored in the sample measurement container and the stated first and second standard luminescence of a standard solution measurement container in the stated sequence and output the respective first and second light intensity signals and standard light intensity signals. Examiner will not place any restriction on whether the optical connection needs to be continuous/constant or can have a structure that brings the sample measurement container and the standard solution measurement container into and out of a position that is optically coupled to the photodetector. Additionally, for examination purposes, the “calculator operatively coupled to the photodetector and configured to subtract” language has been treated by examiner as including sufficient structure to receive and store the respective first and second light intensity signals and standard light intensity signals in the sequence they are output from the photodetector and a set of instructions or software to perform the required subtractions. With respect to claim 2, for examination purposes, the “sequentially detect” language is being treated as requiring the detection of the first and second luminescence of the sample stored in the sample measurement container to occur either before or after the detection of the first and second standard luminescence of the sample stored in the standard solution measurement container. However it is being treated as excluding simultaneous detection or sequential detection in which the second luminescence and the second standard luminescence are detected either simultaneously or sequentially prior to detecting the first luminescence and first standard luminescence detected either simultaneously or sequentially.
Claims 1-5 and 7-10 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. With respect to claim 1, it is not clear what the “wherein a light stored in the sample measurement container and a light stored in the standard solution measurement container are different from each other are different” is intended to claim. Is it that the claim does not cover the specific situation in which the second light intensity signal and the second standard light intensity signal are equal/equivalent/identical? Or does it mean that the detected frequency of the second luminescence is different from the detected frequency of the second standard luminescence? For examination purposes, examiner will treat this language as inherent since the likelihood of the second light intensity signal and the second standard light intensity signal being equal/equivalent/identical is extremely small. Additionally, it is not clear if the “background luminescence of the sample measurement container” language in the calculator paragraph of claim 1 is equivalent to the “second standard luminescence of the sample measurement container” language in the last full paragraph of claim 1 on page 1 of the claims (page 2 of the response filed 3/12/26). If the phrases are equivalent, then applicant should use consistent terminology throughout the claims rather than two different terms. If the phrases are not equivalent (i.e., the background luminescence refers to a dark current measurement and/or a measurement without sample in the sample measurement container), then the claims should be changed to clearly define the background luminescence. For examination purposes, examiner will treat the portion of the calculator paragraph (the first full paragraph on page 2 of the claims – page 3 of the response) of claim 1 starting with the word “thereby” as a repeat of the portion of the paragraph that precedes the word “thereby”. Thus the calculator simply is configured and/or has software capable of subtracting the second light intensity signal from the first light intensity signal to calculate a value related to an amount of the biological signal in the sample. With respect to several of the claims that depend from claim 1, they include further structural elements without defining a structural relationship to the element present in the claims from which they depend or they add additional function for already claimed elements. Thus similar to claim 1 above, it is not clear if applicant is simply claiming a plurality of parts or if the intent is to claim a structurally connected device? To the extent that the further functional language is directed toward the photodetector or the calculator, it will be treated as also being subject to 35 U.S.C. 112(f). For structure that is not being treated as subject to 35 U.S.C. 112(f), the functional language will be treated as not further limiting. With respect to claim 8, the claim includes language similar to that in claim 1 requiring the light stored in the sample measurement container and the standard solution measurement containers to be different from each other. This claim 8 suffers the same clarity issue relative to this language as described with respect to claim 1 above. With respect to claim 9, the structural relationship between the disposal box and the remaining structure of claim 1 is not clear. Is the disposal box located near either of the sample measurement container, the standard solution measurement container, the photodetector or the calculator? Is there some sort of structure for using and discarding the pipette tips or is the disposal box simply a box on a table that an operator manually places pipette tips in for the purpose of discarding them? Claims not specifically addressed above are dependent from one or more of the above claims and fail to remedy the problem(s) outlined above.
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.
Claims 1-5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Noda (US 2012/0250024) in view of Barr (US 5,139,745), Chappelle (US 4,385,113) and Ramsay (US 2005/0221471, newly cited and applied) or Alves (US 2016/0102338, newly cited and applied). With respect to claim 1, Noda teaches a biological sample analysis device shown in figures 1A-1C and 2A-2B. The device has a reagent/sample container holder (22, solution containers 23-28, stores a sample containing a biological substance and a luminescent reagent in a container) and a photo detector (10) that detects the luminescence and outputs a light intensity signal (see at least figure 5 with its associated discussion) and a calculator (control apparatus 2) that controls the apparatus as described in paragraph [0138] to subtract the light intensity signal obtained before the sample and the luminescent reagent react (background light signal of the luminescent reagent) from the light intensity signal obtained after the sample and the luminescent reagent react (the ATP luminescence signal) to remove light stored in the container, and calculates a value related to an amount of the biological substance (an ATP luminescence amount 48 derived from viable cells is calculated from an intensity difference between the intensity of the peak and an average in several seconds to several hundred seconds of the background light signal). In other words, Noda teaches at least a container, a photodetector capable of detecting luminescence and outputting a light intensity signal and some form of calculator or computing device capable of performing the required calculations. Paragraph [0138] also teaches that viable cell counts can be calculated from the obtained ATP amount on the basis of a relation between ATP of known concentration and luminescence intensity (a CPS value) at that point. Figure 6 is a diagram schematically showing a method of calculating an ATP luminescence amount and calculating viable cell counts. 49 denotes an ATP calibration curve obtained by preparing ATP of known concentration and plotting the number of ATP molecules on x axis and plotting luminescence intensity (CPS) on y axis. 50 denotes calibration curves of three kinds of viable microbes obtained by adjusting the concentrations of model species A, B, and C and plotting the number of microbes (CFU) on x axis and plotting luminescence intensity (CPS) on y axis. 51 denotes a graph showing a relation between cell counts (CFU) of the species A, B, and C and ATP amounts on the basis of the ATP calibration curve 49 and the calibration curves 50 of the three kinds of viable microbes. A relation between microbe counts concerning representative microbial cells (index microbes) and ATP amounts is compiled as a database in advance as shown in Figure 6. This makes it possible to calculate viable microbe counts based on a measured amount of luminescence. In other words Noda teaches the presence of at least one standard solution container used to create calibration curves. With respect to the dispensing of fluids, paragraph [0022] teaches that it is possible to measure an amount of ATP molecule equivalent to 1 amol using a dispensing system comprising a washing function for preventing external contamination and a bioluminescence detecting system in which a high-sensitivity detector is arranged in a space in the same apparatus where light is blocked and contaminants from the outside are suppressed. Relative to the measurement process of paragraph [0138], paragraph [0142] teaches that a nozzle washing step is not described in the operation flow shown in Figures 7A and 7B. However, in general, the outer wall (of the nozzle) is immersed in a washing solution before reagent suction and after reagent dispensing. Further, an appropriate amount of buffer solution in a pipe is discharged to wash the nozzle inner wall. In this flow, it is preferable to insert a step of washing the nozzles in the fourth solution container 26 before suction of the ATP eliminating solution, a step of washing the nozzles in the fifth solution container 27 after dispensing of the ATP eliminating solution or before suction of the ATP extraction solution, and/or a step of washing the nozzles in the sixth solution container 28 before suction of the pretreated sample. Relative to claim 2, it adds further function for the photodetector and calculator. Since Noda has a plurality of containers that are treated in sequence, the additional limitations of claim 2 are taught by Noda. Similarly, the limitation of claim 3 adds further function for the calculator. Since Noda teaches a reagent to measure an ATP luminescent signal, the additional limitation of claim 3 is also taught by Noda. With respect to claim 4, the calculator which controls the apparatus as described in paragraph [0138] of Noda and the dispensing mechanism described in paragraph [0128] of Noda teach the respective controller and dispensing mechanism required by claim 4. Since Noda teaches a reagent to measure an ATP luminescent signal, the additional limitation of claim 5 is also taught by Noda. With respect to claim 6, the structure shown in figure 1A, teaches the housing body and door of claim 6. This process also is related to the steps of claim 8. It is noted that examples 2 and 3 discuss measuring a background and the treatment is different. The difference between instant claims 1 and 8 and Noda is what is in the container during the measurement of a second light intensity and a first light intensity: the sample and the sample plus a luminescent reagent respectively and the steps to measure a standard solution.
With respect to claims 1 and 8, Barr teaches a luminometer (10) with a container (14) configured to hold the sample and luminescent reagent and a photodetector configured to record background and signal from the container. Figure 3 shows that the sample 16 is in the container in front of window 28 which allows what is happening in the container to be recorded by the photodetector. Operation of the luminometer is described beginning on column 5, line 40. To begin, the material (16) to be analyzed is placed in container. The container with the material to be analyzed is then placed into optical chamber (12) as substantially shown in figure 2. The optical chamber is closed in order to establish a dark environment within chamber. The container is further moved downward into the position shown in figure 3. With the container and material to be analyzed in the dark environment of the optical chamber, reagents from fluid sources 82, 90 are respectively pumped via fluid lines 80, 92 into the container according to a predetermined assay. What these reagents do for the actual operation of luminometer is described with reference to figure 4 which shows a graph plotting light intensity (I) within optical chamber (as detected by sensor 48) against time (t) for a typical operation of the luminometer. As shown in figure 4, an operational cycle for luminometer begins at t0. Between t0 to t1 is a warm-up period 104 for sensor 48. Immediately following warm-up period 104, a background signal 106 is determined which represents the ambient light intensity within the dark environment of the optical chamber during a sampling period 108 which extends from t1 to t2. After background signal 106 is established, a first reagent held in fluid source 82 can be pumped into the container during the time period 110 that extends from t2 to t3. This is followed by the pumping of a second reagent from fluid source 90 into vial 14 at t4. Approximately between two tenths and three tenths (0.2-0.3) of a second after t4, the material 16 in the container will begin to "light-off". This "light-off" is characterized by a rapid increase in light intensity within the optical chamber 12 as indicated by the curve in figure 4. After curve 114 peaks, there is a more gradual decrease in the light intensity detected by sensor 48 until the curve 114 again indicates that light intensity within the dark environment of optical chamber 12 has returned to a level which is represented by background signal 106. As will be readily appreciated by the skilled artisan, the luminescence from material 16 which is represented by curve 114 is characteristic of the material 16. More specifically, the area under curve 114 is indicative of the concentration of certain constituents in the material 16. Thus, by using well known electronic circuitry in microprocessor 54 to sum all of the instantaneous intensities (i.e. transient instantaneous intensity 118 et al.) during programmable period 116, a descriptive signal can be generated which gives the concentration of certain constituents in material 16. This descriptive signal can be refined to be made more precise by subtracting background signal 106 therefrom.
With respect to claims 1 and 8, Chappelle teaches a bioluminescent assay for ATP in water borne bacteria by adding nitric acid to a water sample with concentrated bacteria to rupture the bacterial cells. The sample is diluted with sterile, deionized water, then mixed with a luciferase-luciferin mixture and the resulting light output of the bioluminescent reaction is measured and correlated with bacteria present. A standard and a blank also are processed so that the light output can be correlated to bacteria in the sample and system "noise" can be subtracted from the readings. An automatic system automatically performs a bioluminescent ATP assay on a concentrated bacterial sample. Reservoirs (containers) are provided for the sample, standard and blank. These are sequentially mixed with nitric acid from a reservoir by using two channels of a peristaltic pump. This acid mixture is then mixed with sterile, deionized water from another reservoir using two additional channels of a peristaltic pump and the resulting mixture is then mixed with a luciferase-luciferin mixture from an additional reservoir by employing two more channels of a peristaltic pump. The resulting solution flows through a photometer which indicates the level of the bioluminescent light reaction. Column 5, lines 21-51 teach that to have the light reading from the ATP in the sample correlated with a known amount of ATP, a standard must be processed with a known amount of ATP. This is done by taking a known amount of pure dehydrated ATP and diluting it to an appropriate concentration in water, e.g., 0.1 µg ATP/ml H2O and adding 0.6 N nitric acid in a 6:1 ratio by volume. The resulting mixture is mixed 1:1 with sterile, deionized water and injected into the luciferase-luciferin mixture in the photometer. To establish a threshold for system "noise" which accounts for part of the light reading, a blank must be processed. The blank involves mixing sterile, deionized water in a 6:1 ratio with 0.6 N nitric acid, then 1:1 with water and injecting it into the luciferase-luciferin mixture. The standard and the blank, therefore, are processed exactly like the bacteria containing sample. In practice, once the blank and standard light reading are obtained, the blank reading is subtracted from both the standard and the sample readings. Since the standard reading is usually very high and the blank reading very low, it is not important to subtract the blank reading from the standard. However, since many sample readings are low, the blank reading is subtracted from those. When the subtraction process is completed, the determination of bacteria in the sample is made through proportionality with the standard since the readings are linear. (The limits of the instrument set the working limits, and the reagents, including enzyme, are adjusted so that a linear relationship is maintained). Examples IV and VII discuss creating blanks (zero solutions) as part of the process.
With respect to claims 1 and 8, Ramsay teaches a device suitable for use in determining the accuracy of a swab technique. Various tests are available that can be used to assess the cleanliness of a surface. Such tests include those based on the detection of ATP using the firefly luciferase reaction, tests based on the detection of protein using colorimetry, tests based on the detection of micro-organisms using microbiological culture techniques, and tests based on detection of micro-organisms using immunochemical techniques. Surfaces can be sampled using either a swab device, or by direct contact with an agar medium. Although the above tests are useful in the detection of a contaminated surface, they are typically prone to errors. These errors may be due to the performance of the measurement apparatus (a light detection device, such as a luminometer, color detection by human assessor, or test result interpretation by human assessor). Paragraph [0009] teaches that the use of chemical standards (such as the use of solutions of ATP to calibrate ATP tests) is known. These can be applied in two ways. The ratio of the signal from the test sample to that of the standard can be used to calculate the amount of analyte present in the sample.
With respect to claims 1 and 8, Alves teaches methods for detecting and quantifying succinate in a sample. Paragraph [0147] teaches that the amount of ATP generated is determined using a luciferase/luciferin reaction. The ATP is utilized by the luciferase, along with luciferin and sufficient molecular oxygen (O2) to drive the detection of ATP, thereby generating AMP, PPi, oxyluciferin, CO2, and light. The herein described assay generates measurable luminescence. Quantifying the amount of luminescence quantifies the amount of ATP, and thus the amount of succinate in a sample. The luminescence (relative light units; RLUs) measured is proportional to the level of succinate present in the sample. Quantitative ATP values are realized, for example, when the luminescence generated from a test sample, is compared to the luminescence generated from a control sample (standard solution) or to a standard curve (calibration curve) determined by using known amounts of ATP and/or succinate, and the same luciferase and reaction conditions (i.e., temperature, pH, etc.). It is understood that quantification involves subtraction of background values or calculating the signal above background. Paragraph [0152] contains a similar teaching. Paragraph [0202] teaches that it may be desirable to include a control sample (standard solution) in any of the herein described methods. The control sample may be a sample that has not been contacted with the compound. The control sample may be analyzed concurrently with the test sample, as described above. The results obtained from the test sample may be compared to the results obtained from the control sample. Standard curves may be provided, with which assay results for the test sample may be compared. Such standard curves present levels of marker as a function of assay units, i.e. luminescent signal intensity.
With respect to claims 1 and 8, it would have been obvious to one of ordinary skill in the art at the time the application was filed to measure the background which is subtracted from the luminescent signal on the sample in the container as taught by Barr and the luminescent signal of a blank (zero solution) as taught by Chappelle because as shown by Barr and/or Chappelle such a process is typical in the luminometer art and is known to remove system noise or light that is normally present when measuring a luminescent signal from a luminescent reagent. It additionally would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the Noda system and method to incorporate the a container for a standard solution as taught by the standard of Ramsay or the control sample of Alves to be analyzed concurrently with the sample as taught by at least Alves for quantifying the analyte as taught by Ramsay or Alves because of the known use of a standard or control solution as an alternative to the calibration /standard curve used by Noda for that purpose as taught by Ramsay or Alves.
With respect to claim 2, Noda teaches a single photodetector with means to move containers sequentially into an optical coupling configuration with the photodetector so that modification of Noda as described above would directly lead to sequential detection of the sample and standard solution in their respective containers. With respect to claim 3, the fact that paragraph [0138] teaches an ATP luminescence amount shows that claim 3 is taught by at least Noda. With respect to claims 4-5, paragraphs [0128]-[0132] of Noda describe the dispensing system shown in figures 2A-2B and the various solutions that are dispensed thereby.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Noda in view of Barr, Chappelle and Ramsay or Alves as applied to claim 1 above, and further in view of Alavie (US 2006/0210435), Keller (US 2010/0136563) or Hori (US 2017/0089934). The difference between instant claim 9 and Noda is the presence of a disposal box that includes disposal spaces respectively partitioned for pipette tips to be discarded.
With respect to claim 9, Alavie teaches an automated analyzer that compactly integrates subsystems for sample dispensing, liquid handling, microplate transport, thermal incubation, vortexing, solid phase separation and optical reading. Paragraph [0096] describes figure 29 as a perspective view of the optical head subsystem used to measure absorbance, luminescence or fluorescence within a reaction plate well. Paragraph [0113] teaches that in the device shown in figure 1, a liquid dispensing system 109 is provided within the analyzer 100 for transferring liquid reagents, calibrators, controls, standards and samples into a microplate well 210. The system 109 may comprise a single robotic pipette or may comprise other liquid handling system configurations, such as a multichannel pipettor for dispensing from one microplate 200 to another and a single channel system for accurately dispensing sample. The liquid dispensing system 109 may employ air displacement, peristaltic, syringe, positive displacement, or other dispensing technologies. The dispensing head may employ disposable tips or may use a single tip that is cleansed in a washing station that is further included within the analyzer. Paragraph [0150] teaches that disposable pipette tips are used to simplify the operation of the analyzer and remove the need for tip washing. Shown in figure 7 is a microplate tip box 500 containing 96 disposable tips 505. A tip 505 is loaded onto the pipette by moving the pipette downwards onto a given tip (or set of tips in the case of a multichannel pipettor) and applying sufficient pressure. Following the use of a tip, it is disposed into the same location in the tip box by lowering the pipette tip into the selected tip receptacle within the tip box and ejecting the tip from the automated pipette.
With respect to claim 9, Keller teaches a system and method for the processing of nucleic acids containing fluids involving manipulation of magnetically responsive particles contained therein. Paragraph [0007] teaches that the invention relates generally to nucleic acids containing fluid processing, and more particularly to a system and method for the automated processing of nucleic acids containing fluids involving manipulation of magnetically responsive particles contained therein. The system providing for the extraction of nucleic acids prior to their amplification has small dimensions relative to the prior art, is easy to manufacture and reliable in use and enables fast extraction of nucleic acids without enlarged risk of contamination and/or spilling of the fluids. Paragraph [0105] teaches that the system 1 has six racks 8-13 including a processing rack 8, a tip rack 9, a first reagent rack 10, a second reagent rack 11, a bottle rack 12, and a waste rack 13. Each rack has a number of retaining sections 18 for accommodating and holding various objects such as multi-well plates, tip cartridges, and bottle cartridges. In Figures 1 and 2, the processing rack 8 is shown to be loaded with three multi-well plates, which is a processing plate 19 to be filled with nucleic acids containing fluids used as starting materials for the extraction of nucleic acids and two output plates 20 to be filled with solutions containing the extracted (purified) nucleic acids. The processing plate 19 and the output plates 20 are micro-well plates in one embodiment, which are also known as microtiter plates, and in another embodiment may be generally a plurality of containers. The tip rack 9 is loaded with three tip cartridges 21 that may be filled with tips, the first and second reagent racks 10, 11 may be loaded with various processing solutions such as buffer and wash solutions which is not further detailed in the figures, the bottle rack 12 may be loaded with plural bottle cartridges to be filled with bottles containing various liquids such as suspensions of magnetically responsive particles which is also not further detailed in the figures, and the waste rack 13 is loaded with three empty tip cartridges 22 to receive waste tips and a waste plate 23 to receive waste liquids arising in processing the nucleic acids containing fluids.
With respect to claim 9, Hori teaches a sample analysis device for speedily and accurately analyzing a plurality of items for a fluid to be measured. Paragraph [0033] teaches that a preferred embodiment of the biochemical analysis device and a preferred embodiment of an analysis chip of are described with reference to the drawings. In this embodiment, a biochemical analysis device 50 that determines an allergy of an analyte as target liquid by means of chemiluminescence resulting from antigen-antibody reaction by employing the ELISA (enzyme linked immunosolvent assay) process and an analysis chip 10 used in the biochemical analysis device 50 are described as an example of a sample analysis device and an example of an analysis chip of the present invention respectively. Paragraph [0079] teaches that the pipette chip attachment position of the pipetting unit 90 is a position employed for attaching an unused pipette chip 95 to be placed in the reagent holder unit 58. The pipette chip detachment position of the pipetting unit 90 is a position employed when a used pipette chip 95 is detached from the pipetting nozzle 92 by a pipette chip detachment mechanism (not illustrated in the drawings) of the reagent holder unit 58. Paragraphs [0091]-[0093] describe the reagent holder unit 58 as being for installation of a reagent cartridge 96 and the pipette chip 95. The reagent cartridge 96 stores multiple types of target liquid to be injected into the analysis chip 10 including a blocking solution, an analyte, a luminescent substrate, a cleaning liquid, etc. A plurality of unused pipette chips 95 are also placed in the reagent cartridge. The pipette chip 95 is attached to the pipetting nozzle 92 of the pipetting unit 90. The pipette chip 95 is a disposable chip to be changed for each liquid to be injected. The reagent holder unit 58 of this embodiment includes a disposal housing part 97 for housing a used pipette chip 95 and the pipette chip detachment mechanism (not illustrated in the drawings). The pipette chip detachment mechanism detaches a used pipette chip 95 from the pipetting nozzle 92. The disposal housing part 97 is shown as having receptacles for the used pipette chips.
With respect to claim 9, it would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the Noda system and method to use disposable pipets and place the used pipets in a disposal box that is either the original tip rack as taught by Alavie or a separate disposal rack or housing as taught by Keller or Hori having receptacles for individual pipets as taught by Alavie, Keller or Hori because of their recognized benefits related to contamination prevention, analyzer operation simplification and elimination of the need for tip washing as taught by at least Alavie.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Noda in view of Barr, Chappelle and Ramsay or Alves as applied to claim 1 above, and further in view of Cable (US 2004/0127781). The difference between instant claim 10 and Noda is the presence of uneven structures on contact portions of the housing opening and the door which fit to each other when the door closes the opening.
With respect to claim 10, Cable teaches an improved imaging apparatus that allows a user to perform numerous imaging operations. The imaging apparatus may include one or more improvements to imaging box design to improve illumination control within the imaging box, such as improved door seal arrangements, improved door closing mechanisms, and improved light seals. Paragraph [0003] teaches that a specialized type of imaging involves the capture of low intensity light--on the order of individual photons--from a light emitting sample. Such imaging applications present particular challenges to the design of a box or chamber in which the sample is contained during imaging. Paragraph [0004] teaches that one particular challenge to imaging box design is the diverse lighting needs required during image capture. Photographic image capture typically requires the sample to be illuminated. Luminescent image capture requires substantially no light other than minute amounts produced within the sample. Conventional "light boxes", or "specimen chambers" have thus been developed to maintain the sample being imaged in relative darkness during luminescent image capture. Figures 1B and 1C illustrate a seal 4 situated between the door 1 of an imaging device and the front wall of the box that the door is attached to. The seal is taught as allowing a significant amount of light to enter the light box. Paragraph [0006] teaches that conventional imaging boxes or specimen chambers may not be adequate for many imaging applications, e.g., when the imaging involves the capture of low intensity light on the order of individual photons. In view of the foregoing, improved imaging apparatus would be desirable. Paragraph [0054] teaches that figures 4, 5A, 5B, 5C and 5D illustrate different embodiments of a light-tight seal formed by cooperation between the door 18 and the body 14 of an imaging box shown in figure 3. Each of the seals 61a, 61b, 61c and 61d in figures 5A, 5B, 5C and 5D, respectively, may include a compressible material 62. In one embodiment, the compressible material 62 is non-transparent, preferably black, and made from a resiliently deformable material. In a specific embodiment, the compressible material 62 is an elastomer having a modulus of elasticity of less than about 1000 psi. Preferably, the compressible material's modulus of elasticity is less than about 200 psi, and more preferably is less than about 100 psi. In another embodiment, the material has a durometer rating of between about 10 and about 50, and preferably between about 20 and 30. Each of the seals has uneven structures respectively provided on contact portions of the opening of the housing body and the door, the uneven structures being fitted to each other in a state where the door closes the opening. Paragraphs [0055]-[0064] give a detailed description of the structure shown in figures 4 and 5A including the various components and how they fit with each other when the door closes the opening to block the light from entering the imaging box. Paragraph [0065] describes the modification of the figure 5A structure shown in figure and its ability to provide additional light sealing. Paragraphs [0070]-[0072] describe the seal structure shown in figure 5D and the reasons it blocks the light from entering the imaging box. Paragraphs [0066]-[0069] describe the seal structure shown in figure 5C and the reasons it blocks the light from entering the imaging box. Paragraph [0082] teaches that advantageously, the design of the seal 61 and the distributed manner in which the seal 61 is engaged when the door 18 is closed provide a substantially more light-tight imaging box than was previously available, as evidenced by the comparison testing described in paragraphs [0104]-[0106].
With respect to claim 10, it would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the Noda system and method to incorporate the uneven structures such as shown/taught in figures 5C and 5D of Cable respectively provided on contact portions of the opening of the Noda housing body and the door, the uneven structures being fitted to each other in a state where the door closes the opening as taught by Cable for a housing and door uses to measure weak luminescent signals because of the improvement in light blocking when such a light blocking seal is used as taught by Cable.
Claim 7 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b), set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the art of record fails to teach or fairly suggest the combined structure of claim 7.
Applicant's arguments filed March 12, 2026 have been fully considered but they are not persuasive. In response to the amendments, the new matter rejection has been withdrawn, the clarity rejection has been modified to cover additional problems and/or claim changes resulting from the amendments and the obviousness rejection has been modified to cover the changes to at least claims 1 and 8. The arguments directed toward the withdrawn rejection are moot.
With respect to the claim interpretation and examiner’s use of 35 U.S.C 112(f) with respect to the photodetector and calculator, examiner agrees that they are known devices/elements. However, 35 U.S.C 112(f) is directed to situations in which the claims include a means or similar generic placeholder for performing a specified function without the recital of structure, material, or acts in support thereof. A photodetector and calculator can come in many forms and be controlled to perform many different functions so that by themselves, they are terms that are generic in nature. If applicant were just claiming a photodetector or a calculator that would not be a problem with respect to 35 U.S.C 112(f). The connectivity of these elements to the other elements of the device also does not create a problem that needs the use of interpretation under 35 U.S.C 112(f). A photodetector is an element capable of detecting/measuring light and its structural relationship to another element of the device helps define the claim scope. However, if applicant wants examiner to consider how the photodetector functions as part of the claim structure – detecting a second luminescence of the container after the sample is stored in the container and before a luminescent reagent is added to the container, and a first luminescence of the container after the sample is stored in the container and after the luminescent reagent is added to the container, and output a first light intensity signal corresponding to the first luminescence and a second light intensity signal corresponding to the second luminescence – some sort of controller/microprocessor with software is needed. That structure is not ordinarily part of a photodetector nor is it part of the structure required in claim 1 so that the photodetector is configured to perform the function. The use of 35 U.S.C. 112(f) to interpret these claim elements is because the claim(s) do not contain sufficient structure (i.e. a control structure with appropriate software, instructions and/or structure) to perform the stated function(s). Thus the term photodetector is acting as a generic placeholder that recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Based on this, the presumption that the claim limitation should not be interpreted under 35 U.S.C. 112(f), is rebutted and examiner’s interpretation of the claim limitation under 35 U.S.C. 112(f) is proper for the photodetector. Similarly the calculator is a generic label for something that performs mathematical operations as applicant has explained. However, subtracting the second light intensity signal from the first light intensity signal to calculate a value related to an amount of the biological substance in the sample is a fairly specific mathematical operation that requires a specific set of commands. In other words the calculator either needs some sort of controller/memory with associated software or analog circuitry capable of performing the stated function. Such circuitry or controller/memory and associated software are not claimed in claim 1. Here again, if applicant wants examiner to consider the specific function of the calculator as a limitation of the device, examiner’s interpretation of the claim limitation under 35 U.S.C. 112(f) is proper. An evidence that applicant intends for the functional language to have patentable moment can be found in the arguments directed toward the obviousness rejection. On page 14 of the response, applicant argued that the “configuration” for a sample measurement container and a standard solution measurement container includes/requires the timing and/or sequence of detecting a first and second luminescence under certain conditions that are claimed as part of the function associated with the photodetector element of claim 1. The only way that argument carries patentable moment is if the photodetector language of the claims is interpreted under 35 U.S.C. 112(f). With respect to the calculator, the detection of the first and second luminescence do not occur simultaneously so that the second light intensity signal derived from the detection of the second luminescence needs to be held/stored until it can be subtracted from the first light intensity signal. Thus in order for the functional language to happen, there needs to be sone sort of structure/controller capable of holding/storing the second light intensity signal until the first light intensity signal is available and some sort of set of instructions that causes the subtraction to occur when the first and second signals have been obtained. While a calculator may potentially have a memory/storage location and a set of instructions to perform a subtraction of two numbers, the conditions after/under which the subtraction occurs in not something inherent to every calculator. Thus, the only way that the argument(s) directed toward the calculator would have patentable moment that distinguishes over the applied art is if the calculator language of the claims is interpreted under 35 U.S.C. 112(f). Thus the argument is not persuasive and the claims are still being interpreted under 35 U.S.C. 112(f).
With respect to the clarity rejection, first examiner notes that whether the elements of the device appear in the independent claim or a dependent claim, clarity requires that the structural relationship to the other elements of the device is defined. Thus whether the disposal box and/or the housing are elements of an independent claim or a dependent claim the structural relationship with the other elements of the claim and/or the claim(s) from which it depends need to be defined. With respect to the question of whether a separate controller is required is a valid question since the claim does not claim a structure that is capable of controlling the photodetector and/or unclaimed structure used to provide the optical coupling between the photodetector and the sample measurement container and/or the standard solution measurement container if that optical coupling is not a continuous optical coupling. Additionally the fact that the calculator might perform timing and signal processing functions does not change the fact that the claims do not designate/define structure that controls the photodetector to perform the accompanying functional language. For example is it simply a timing issue or does the device need to monitor when a sample or standard solution has been placed in the respective measurement containers or when a luminescent reagent has been added to the respective containers? Alternatively, is applicant attempting claim a scope that would cover the manual performance of the assay so that the claim literal covers two containers, a device capable of measuring luminescence and outputting a signal/number related to the amount of luminescence that was detected/measured and a calculator that the person performing the assay can use to perform the required subtractions so that the person performing the assay is causing/controlling when the respective luminescence is detected and a signal is outputted and provides the operative connection between the photodetector and the calculator? Use of the configured to language to define the function of the photodetector and the calculator point to some sort of control in the device that causes them to function in a certain manner. Part of examiner’s reason for making these rejections is to point out that the claims do not have sufficient structure to enable the functioning of the photodetector and/or the calculator in the stated manner. Thus if applicant wishes to have examiner stop interpreting the claims under 35 U.S.C. 112(f), the claims need to define sufficient structure to enable the elements to perform the stated functions. Thus the amendments failed to correct the clarity issues that remain from the previous office action and/or the new issues resulting from the amendments made by applicant.
With respect to the obviousness rejection, the newly cited and applied Alves and Ramsay references are directed to methods for measuring luminescence and show that the inclusion of a standard or control sample having a known concentration of the analyte is an alternative to a calibration curve to quantify the analyte from the luminescence measurements. Alves in particular teaches concurrent analysis of the sample and control/standard which would require the presence of a container for optical coupling to the photodetector. Thus the application of these newly cited and applied references is examiner’s response to the claim changes to claims 1 and 8. Examiner notes that the Cable reference is no longer applied against claims 1 or 8 since the limitations that required it have been moved to claim 10. Thus the response to the argument against the obviousness rejection is the addition of these new references to the rejection. For the above reasons the arguments are not persuasive.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additionally cited art is related to various luminescence measurement methods and devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Arlen Soderquist whose telephone number is (571)272-1265. The examiner can normally be reached 1st week Monday-Thursday, 2nd week Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached on (571)272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARLEN SODERQUIST/Primary Examiner, Art Unit 1797
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