DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 9 and 11-13 use the phrase “is provided” when introducing elements, wherein such language may be interpreted as being drawn to process-type language. Applicant is requested to amend the claims to instead recite the cuvette unit “further comprising...” the additional elements. The recitation “is provided” provides an implicit description of the element’s positive presence in the device.
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 limitations are:
“a reading device for reading” as in Claim 8.
“transmit/receive unit...which transmits” as in Claim 9.
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.
“a camera” as in para. [0022] of Applicant’s instant pre-grant publication US 2024/0408604 A1...and equivalents thereof.
“an antenna” as in para. [0038] of Applicant’s instant pre-grant publication US 2024/0408604 A1...and equivalents thereof, or “a signal cable” as in para. [0021] of Applicant’s instant pre-grant publication US 2024/0408604 A1...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 8-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the unique cuvette identification". There is insufficient antecedent basis for this limitation in the claim. The claim should be amended to recite “the
Claim 1 recites “wherein the cuvette rack unit does not comprise an analyte analyser” however, the claim also provides for “a separate analyser comprising a quantitative analyte analyser” wherein it is thereby unclear is the quantitative analyte analyser is what is being omitted or if the analyte analyser is a separate element. It is further thereby unclear is the quantitative analyte analyser is a positively necessitated element of the claim or is a mere expected workpiece worked upon by the rack unit merely by sending and receiving signals therewith. Additionally, it is unclear if the term “separate” referring to the analyser refers to the analyser being a separated element from the rack, or if an additional analyser is being provided for.
Claims 9 and 14 recite “a transmit/receive unit” wherein the term is ambiguous and renders unclear if the unit is for transmitting, receiving, or both. Applicant may wish to amend the claims to recite “a transmit and receive unit”. Further, Claim 14 relies on the “transmit/receive unit” term to seemingly provide for a second transmit/receive unit, thereby rendering the terminology confusing as to which of the units the term refers. Applicant may wish to amend the claim to recite “a second transmit/receive unit”.
Claim 12 recites “wherein an input key associated with the analysis preparation control is provided” wherein the “input key” is provided as a mere additional parts listing not being specifically structurally or functionally related to the cuvette unit. Merely reciting “associated with the analysis preparation control” is not sufficiently specific such that one of ordinary art would understand the input key’s position/function within the arrangement. Further, it appears that the “input key” may be drawn to a button for controlling the analysis as suggested by Applicant’s disclosure. If this is the case, Applicant may wish to recite the controller “configured with” the key to perform the desired function of activating or deactivating a process, such details being presently lacking in the claim.
Claim 13 recites “wherein an electric connector connected to the analysis preparation control is provided for directly connecting a further cuvette rack unit” wherein this recitation is unclear given that no particular electrical connector of the rack unit is positively provided. Applicant merely provides electric connectors to the control unit and does not specifically provide the actual means by which the respective rack units are connected and electrically interfaced. Thus, the metes and bounds of what constitute the “for directly connecting a further cuvette rack unit” are unclear.
Claim 14 recites “a separate scale-free analyser unit” wherein, similarly as above, it is unclear what the term “separate” is intended to convey. Further, the term “scale-free” is particularly ambiguous. If it is Applicant’s intent that the separate analyser unit not have a scale, Applicant may wish to amend the claim to recite “a separate analyser unit without a scale for determining weight”. Further, Applicant has provided a combination-type claim; however, the claim is lacking in a particular structural or functional relationship linking the scale-free unit to the rack unit of Claim 8, thereby amounting to a mere parts listing. The same is true of the “controller”, “transmit/receive unit”, and “reading device” of the scale-free unit, wherein these three elements are not particularly structurally or functionally related and are thereby drawn to a mere parts listing, the arrangement of which having inadequate metes and bounds and thereby is indefinite.
Claim 14 recites the limitation "the transmit/receive unit of the analysis preparation cuvette rack unit ". There is insufficient antecedent basis for this limitation in the claim. Claim 14 depends from Claim 1; however, the transmit/receive unit is only previously introduced by Claim 9. Applicant may wish to amend the claim to incorporate Claim 9 instead of Claim 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 8-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ulrich (US PAT 6,375,898 B1), hereinafter “Ulrich”, in view of Meusel et al. (EP 3249386 A1, as seen through the machine translation available on Google Patents and attached herein.), hereinafter “Meusel”.
Regarding Claim 8, Ulrich teaches a unit for analysis preparation, comprising:
a sample cuvette (See Fig. 6 showing cuvettes 144’’/144’’’ comprised in the overall sample carrier 102.) comprising a cuvette identification on a sample cuvette information carrier (col. 5, line 35: “The cuvettes or the system-reagent carrier may be provided with a machine-readable identification code for the respective reagent contained therein, and the analysis appliance may have a device for reading this identification code.”),
a reading device 64 for reading the unique cuvette identification of the sample cuvette information carrier of the sample cuvette held by the cuvette platform (See Fig. 3 and col. 6, line 39: “the cuvette or the system-reagent carrier is provided with a manufacturer identification coding which can be read and evaluated by a reading device...”); and
an analysis preparation controller 22 informationally connected to the reading device 64 for storing and transmitting an associated read cuvette identification to a separate analyzer comprising a quantitative analyte analyzer (col. 6, line 16: “a control device for controlling the drive of the rotor and the drive of the lifting/pivoting device, and for controlling the operation of the pipetting device and the detector device” – col. 5, line 42: “the control device of the analysis appliance, as well as the evaluation device, are able to further process the data obtained from the reading device” – col. 12, line 28: “The information concerning the reagent contained in the measuring cuvette 44 is passed to the evaluation device 23 by the reading device 64 which, when the measuring cuvette 44 moves past the reading device 64, reads the identification code which has been applied to the measuring cuvette 44 and transmits it to the memory device 23′.”),
wherein the cuvette rack unit does not comprise an analyte analyzer (See Fig. 5 showing the analysis appliance (carousel 89 and pipettor 18) as being separate from the cuvettes of Fig. 6, and the reader 64.),
as in Claim 8.
Further regarding Claim 8, Ulrich does not specifically teach the cuvette analysis unit discussed above further comprising a cuvette platform for holding upright a sample cuvette, and a platform scale for determining a weight value of the sample cuvette held by the cuvette platform, as in Claim 8.
However, Meusel teaches a respective unit for analysis preparation, comprising:
a cuvette platform 7 for holding upright a sample cuvette 3 (See Fig. 2 showing the cuvette 3 on the weighing platform 7.);
a platform scale for determining a weight value of the sample cuvette 3 held by the cuvette platform (Abstract: “a weighing device for weighing the cuvette” See also page 4, lines 22-25: “Straight measuring devices, which work by means of weighing or optical detection, are easy to integrate into a photometer. Since a photometer must have a cuvette holder, this can be designed as a weighing platform, so that the photometric measurement and the weight determination can be carried out together and thus a simple, fast and error-free measurement is possible.”).
Therein, this arrangement allows for rapid and accurate volume measurement of the contents of the cuvette. Meusel describes the necessity for such accurate volume measurements as being important for accurately determining a concentration of a sample by photometric analysis. Such photometric analysis is similarly discussed by Ulrich (col. 12, line 17: “the measuring cuvette 44 has reached the detector device 20, where the photometric analysis of the mixture of reagent and sample contained in the measuring cuvette 44 takes place in a known way.”). As such, it would be recognized that implementing the volume scale measurement of Meusel into Ulrich would enhance the accuracy of measurement in Ulrich as an accurate sample volume is determined by weight.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the analysis unit of Ulrich further comprising a cuvette platform for holding upright a sample cuvette, and a platform scale for determining a weight value of the sample cuvette held by the cuvette platform, such as suggested by Meusel, so as to improve measurement accuracy and precision in Ulrich for photometric concentration measurements, as is similarly contemplated by Ulrich, thereby representing a reasonable expectation of success.
Further as in Claim 8, regarding the “an analysis preparation controller informationally connected to the platform scale for storing and transmitting a sample volume parameter based on the weighed sample cuvette weight value to a separate analyzer comprising a quantitative analyte analyzer”, given that the device of Ulrich aims for a high level of automation (see col. 5, lines 35-48), and that Ulrich already utilized a control system to transmit sample-related information to an analysis system, one of ordinary skill in the art would find it obvious to provide a commensurate such arrangement regarding weight transmission to the analyzer so as to maintain such automation and the advantages thereto. Merely adding weight measurement to the information handling system of Ulrich would have a reasonable expectation of success because the claimed information handling architecture already exists in Ulrich.
Regarding Claim 9, the prior art meets the limitations of Claim 8 as discussed above. Further, modified Ulrich as in Claim 8 teaches the analysis unit discussed above wherein a transmit/receive unit informationally connected to the analysis preparation controller is provided, which transmits the sample volume parameter and the corresponding cuvette identification to the analyzer (col. 12, line 21: “The data recorded by the detector device 20 is then transmitted to the evaluation device 23, where it is evaluated in a manner known per se using calibration data stored in the memory device 23′, whereupon the data recorded by the evaluation device 23 are transmitted to the display device 82 and/or the printer 84.” – Therein, as the data recorded by the detector is “transmitted” to the evaluation device (analysis unit) the control unit 22 interfaced with the detector device must necessarily comprise a transmit/receive unit so as to send and receive signals to the preparation unit.), as in Claim 9.
Regarding Claim 10, the prior art meets the limitations of Claim 8 as discussed above. Further, Ulrich teaches the analysis unit discussed above wherein the information carrier is a label and the reading device is a camera (col. 9, line 35: “The analysis appliance 1 furthermore has a reading device 64, which is located in the area of and outside the circumference of the reaction rotor 12. The reading device 64 may be designed as a plain text reader, as a pixel code reader and/or as a bar code reader, in a known way” – The disclosed readers of Ulrich thereby reasonably suggest a camera be utilized as is general practice with such readers.), as in Claim 10.
Regarding Claim 11, the prior art meets the limitations of Claim 8 as discussed above. Further, Ulrich teaches the analysis unit discussed above wherein an optical information display connected to the analysis preparation control is provided (col. 9, line 29: “a display device 82, which is used to display the results”), as in Claim 11.
Regarding Claim 12, the prior art meets the limitations of Claim 8 as discussed above. Further, Ulrich teaches the analysis unit discussed above wherein an input key associated with the analysis preparation control is provided (col. 9, line 28: “inputting data to the control device 22”), as in Claim 12.
Regarding Claim 14, Ulrich in view of Meusel teaches an arrangement comprising a cuvette rack unit according to claim 8 (See Claim 8 above.) and
a separate scale-free analyzer unit comprising a quantitative analyte analyzer, the analyzer comprising an analyzer controller (col. 5, line 16: “the evaluation unit may also be formed by an external, commercially available computer, which is provided with suitable data and programs for evaluation and is connected to the analysis appliance of the analysis system via an interface” – See Fig. 2 showing the control device 22 and the evaluation device controller 23 and memory 23’. – See also col. 5, line 20: “If the analysis system is provided with an evaluation unit...”),
a transmit/receive unit for communicating with the transmit/receive unit of the analysis preparation cuvette rack unit for receiving the cuvette identification and the associated sample volume parameter (col. 12, line 21: “The data recorded by the detector device 20 is then transmitted to the evaluation device 23, where it is evaluated in a manner known per se using calibration data stored in the memory device 23′, whereupon the data recorded by the evaluation device 23 are transmitted to the display device 82 and/or the printer 84.” – Therein, as the data recorded by the detector is “transmitted” to the evaluation device (analysis unit) the evaluation device must necessarily comprise a transmit/receive unit so as to send and receive signals to the preparation unit. – col. 9, line 22: “The [photometric] detector device 20, the evaluation device 23 and the memory device 23′ are to this end connected to one another in order to exchange data, in a manner which is not shown.”), and
a reading device for reading the unique cuvette identification of the sample cuvette information carrier of the inserted sample cuvette (col. 12, line 28: “The information concerning the reagent contained in the measuring cuvette 44 is passed to the evaluation device 23 by the reading device 64 which, when the measuring cuvette 44 moves past the reading device 64, reads the identification code which has been applied to the measuring cuvette 44 and transmits it to the memory device 23′.”),
as in Claim 14
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ulrich in view of Meusel, as applied to Claims 8-12 above, and in further view of Holmes et al. (US 2014/0073043 A1), hereinafter “Holmes”.
Regarding Claim 13, the prior art meets the limitations of Claim 8 as discussed above. Further, Ulrich/Meusel does not specifically teach the analysis unit discussed above wherein an electric connector connected to the analysis preparation control is provided for directly connecting a further cuvette rack unit, as in Claim 13.
However, Holmes teaches a respective controller and modular “plug-and-play” system for laboratory liquid sample preparation and analysis wherein the controller comprises electric connectors for connecting modules of various type to the system ([0595]: “In some situations, the controller is configured to detect a module. In such a case, when a user plugs a module into the system [with an implicitly provided electric connector plug], the system detects the module and determines whether the module is a multi-use module or special-use module.”) including various grippers ([0339]) and/or pipettes ([0340]) for preparing the liquid sample for analysis. Therein, such a modular arrangement provides for a system having the benefits of adjustable throughput with the addition of more modules, as well as analytical multiplexing such that the system may perform several different assays.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the analysis unit of Ulrich/Meusel wherein an electric connector connected to the analysis preparation control is provided for directly connecting a further cuvette rack unit, such as suggested by Holmes, so as to provide a conveniently adjustable/customizable system for adjusting the level of throughput and the number of assays performed thereby.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN KASS whose telephone number is (703)756-5501. The examiner can normally be reached Monday - Friday from 9:00 A.M. to 5:00 P.M. EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi, can be reached at telephone number (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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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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