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 I, claims 1-11 in the reply filed on August 18, 2026 is acknowledged.
Claims 12-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 18, 2026.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the steps listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
It is noted that the term “and/or” is interpreted minimally as ‘or” that provides for alternatives, not requirements.
It is noted that “a laboratory automated device” not is not defined by any specific structures in the claim, including any structure (computer, processor, controller, programmed electrical structure) that can provide for any automation. It is noted such “laboratory automated device” as recited in the claim 1 is structurally defined as only a pipette.
It is noted that the phase “at least one of:” such as in claim 5 only requires one.
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 1-11 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.
It is unclear who and/or what is required to perform the method as defined by each of the steps recited in the claims because the claims do not recite such. It is noted that the “unknown” liquid is not required to be aspirated from nor dispensed to any specified structure/location. Furthermore, it is noted that the determining” steps can be performed mentally and/or manually. For example, one can view and observe “a pipette” relative to a ruler (or any structure/means that can provide for measurements) and other structures of known dimensions such that physical parameters (dimensions; properties including a radius, diameter, length, width, height, etc.) of the pipette and/or liquid can be visually observed/ and/or determined mentally.
As to claim 1 (and any other claim), it is unclear what is considered as “physical parameters of an unknown liquid” because the claim does not provide for such. It is noted that “physical properties” can be considered as the same as “physical parameters”. Furthermore, it is unclear what is required of a liquid to be considered as “unknown” because the claim does not provide for such. Any liquid and parameter, can be subjectively considered as “unknown” relative to someone/something who does not know.
The term “unknown” in claims 1-3, 6-7, and 9-11 is a relative term which renders the claims indefinite. The term “unknown” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “unknown” is not defined in the specification by any specific definition nor in the claims. There is no indication as to what is required of a of liquid and parameters to be considered as “unknown”. Just because one person or thing does not know something about a liquid and parameter does not mean another person does not know anything about (what is) the liquid and a physical (property) parameter of the liquid. The same rationale is applicable to the term “known” as employed in claims 2-3.
As to claims 1-2, it is unclear what is structural nexus of the “a pipette” recited in the first paragraph of claim 1 beginning with “determining…” (and “a pipette” recited in the second paragraph of claim 2) to the “a pipette” recited in the next paragraph of claim 1 beginning with “aspirating sand/or dispensing….”; if such are the same pipette or different because the claims do not clearly recite such. Therefore, it is unclear which/what pipette is being referenced by the phrase “the pipette” later recited in claims 1-3, 5-7, and 9-10.
Furthermore, it is unclear what is required to be done by/who or what to be considered as “measuring a measured pressure curve in the pipette during aspirating and/or dispensing” because the claim does not specify such. It is noted that “a pressure curve” is not structure of a pipette, but is a graphical, mathematical representation of pressure measurements. This can also be performed manually (via paper, writing on paper….forming mathematical calculations, drawing/plotting measured pressure values on paper (and/or via conventionally known graphing calculator, computer, etc.)…to provide for a graph where such data provides for a “curve”) and/or mentally via ones’ eyes and/brain.
Furthermore, in the second paragraph of claim 1, it is unclear what aspirating and/or dispensing is being reference by and/or is inclusive within the phrase “during aspirating and/or dispensing” because the claim does not clearly recite such. If such phrase, is intended to refer to the “aspirating/dispensing of the unknown liquid”, the claim should clearly recite such. Also applicable to last paragraph of claim 1, and the phrase as recited in claims 2 and 7.
As to the last paragraph of claim 1, it is unclear what is required, to be done by who and/or what to be considered as “determining the physical parameters of the unknown liquid by minimizing an objective function depending on a difference between a simulated pressure curve and the measured pressure curve” because of reasons state above and additionally because “an objective function” (is this structure?…of any structure recited in the claim?) is defined the claim nor is there any indication as to what “objective function” of what is being referenced in the in the claim and what is required of such objection function to be considered as being related to physical parameters of the liquid because the claim does not clearly recite such. Also applicable to “the objective function” recited in claims 2, and 7-8.
Furthermore, it is noted that the claim does provide for/list any step that requires anyone nor anything to perform any simulating of anything to provide or a “simulated pressure curve”. This can also be done manually and mentally as previously stated. No curves/plots of any pressure value(s) are required to be tangible nor to compared (by anyone or anything) to provide for any “difference”. However, it is noted that any “difference” is a difference. As noted above, the claim does not provide for what is required to be considered as “an objective function”. Furthermore, it is unclear what is required to be done by who/what to be considered as “minimizing” an unspecified, undefined “objective function”. Also applicable to claim 2.
Furthermore, it is unclear what is calculated by who/what and what is required for such calculation to be considered as “based on a physical model of the laboratory automation device including the physical parameters of the pipette” because in addition to remarks above, it is unclear what is required to be considered as “a physical model of the laboratory automation device” because such is not clearly defined in the claims. It is unclear if such is intended to refer to a model such as in a computer model (i.e. a specific computer program, algorithm, etc.), a model drawing, an actual “physical model” such as a physical structural, scaled physical representation (like or similar to known airplane, car, building, architectural, construction, models, etc. a scaled “physical model” of anything indented to be built, manufactured, etc.), or some other physical model, then the claim should clearly recite such. Also applicable to claim 2.
Furthermore, it is unclear what is required to include “the physical parameters of the pipette”…the model of the laboratory automation device, or device itself, because the claim does not clearly recite such. However, as previously stated, such model of the laboratory automation device, device, and physical parameters of the pipette are not clearly defined in the claim. The only physical parameter of the pipette recited in the claim is “a tip radius”.
As to the last 2 lines of claim 1, see rejections above directed to “physical parameters” and “objective function”. Neither of such are clearly defined in the claim. Furthermore, it is unclear what is required to be done by who/what to be considered as “the physical parameters of the unknown liquid are varied to minimize the objective function” because the claim does not clearly recite such. There is no step recited in the claim that requires “varying” (no defined) of any physical parameters of the unknown liquid to (results in) minimizing of an unspecified “objection function”.
Claims 2-11 are rejected via dependency upon a rejected claim.
As to claim 2, it is unclear how the pressure curve of claim 1 is a second curve because there prior no prior mention of first a pressure curve nor requirement for a first pressure to be involved in and produced in the method claim 1. Renaming, referring to the pressure curve of claim 1 as second, third, etc. pressure curve does not require any further steps to that recited in claim 1 as defining the method.
The term “known” in claims 2-3 is a relative term which renders the claims indefinite. The term “unknown” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term “known” is not defined in the specification by any specific definition nor in the claims. There is no indication as to who/what is required know constitutes “known”. See also rejection above directed to the term “unknown”.
As to claim 2, in addition to the above applicable rejections, it is unclear what is the nexus of “a simulated pressure curve” to “a simulated pressure curve” recited in claim 1 “a physical model of the laboratory automation device” and “a physical model of the laboratory automation device”, if such are the same or different because the claim does not provide for such. Furthermore, it is unclear what is required to be done by who/what such the physical parameters of the pipette are “varied to minimize the objective function” because the claim does not recite such.
As to claim 3, it is unclear what is considered as an “equal pipette” and “equally shaped” because the claim does not clearly recite such. It is unclear what an “equal pipette”, what such is and how is such pipette is equal to anything because the first paragraph of the claim does not provide for such. It is noted that the last 3 “wherein” paragraphs of the claim are directed to alternatives, not requirements as indicated by the term “or”. Therefore, only one of the paragraphs are required. Therefore, the second, equal pipette is not required to be “equally shaped the pipette” (presumed to be referring to the pipette previously recited in claim 2) because the claim does not clearly provide for such. It is unclear if this meant for the second equal pipette to have just a same shape and not necessarily all of the exact same dimensions because the claim does not clearly recite such. It is noted that a single pipette can have number of shapes (of cross-sections). Therefore, both pipettes can have a same shaped circular cross-section and not be of the same dimensions. If applicant intends for such pipettes to be exactly the same as in same size, shape, and dimensions, then the clam should clearly recite such.
As to claim 3, it is unclear what is required by the last two alternative paragraphs because the method does provide for any step that requires anyone nor anything to pick up any pipette from any container nor step of manufacturing any pipettes. How the pipettes were previously manufactured by any prior processes does not further limit the instant method being claimed. Furthermore, it is one is responsible for the prior manufacturing of such pipettes one already knows physical parameters (properties) of the pipettes.
As to claim 4, it is unclear which/what physical parameters and of what is being referenced by “the physical parameters” because the claim does not recite such.
Claim 4 recites the limitation "the second measured pressure curve" in line 3. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear what aspiration is being referenced in claim by “the aspiration” because no aspirating of anything is required to be performed in claim 1. Aspirating is an alternative to dispensing as indicated by the term “or”. If applicant intends for method to require a step(s) directed aspirating something specific from something specific, then the claims should clearly provide for such.
As to claim 5, it is unclear what is “a geometric model” because of the same reasons stated above relative to “a physical model”. See above rejection of claim 1. Furthermore, the phrase “an interior surface the pipette” appears to be grammatically incorrect.
Claim 5 recites the limitation "the orifice” in line 4. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear what conical section of what is being referenced in the phrase “a conical section ending in the orifice”.
Furthermore, it is unclear what is required by “a second radius at another end of the conical section” because there is prior mention of any first radius and what conical second of what is being referenced by “the conical section” because the claim does not clearly recite such. However, it is noted that the claim previously recites “at least one conical section” and there is no prior mention of any (first) end to determine what is considered as “another end”.
Claim 5 recites the limitation "the other end” in line 5. There is insufficient antecedent basis for this limitation in the claim. The other end of what? Nothing has been claimed as comprising any ends.
As to claim 5, it is unclear what ends of further conical sections of what is being referenced in the last line and what is required of such conical sections to be “further” and how any ends are related to and define such “further conical sections” because the claim does not recite such. The claim as a whole in view of claim 1 is confusing.
As to claim 6, it is unclear how a pipette can have a filter resistance without the pipette being required to comprise a filter. Furthermore, it is unclear what the surface tensions and wetting angle of the unknown liquid is being referenced in the claim because each of such would not solely depend upon the liquid itself, but also depends on the location of such liquid (in and in contact with). For example, a liquid in contact with one surface will not necessarily have the same wetting angle when contact with a second different surface. Here, no relative basis is provided for in the claim.
As to claim 7, it is unclear if a pipette of claim 1 is required to be employed in the aspirating and dispensing the unknown liquid from where/what and to where/what because the claim does not recite such. As presently drafted, no pipette is required to employed is such step and the unknown liquid is not required to be aspirated from any specific structural location nor dispensed to any specific location. See also prior rejection above directed to “during aspirating and dispensing”. It is presumed that such is intended to be directed to the aspirating and dispensing of the unknown liquid.
As to claim 9, it is unclear what is the nexus of physical properties of the unknown liquid and pipette, if such are the same or different because the claim does not clearly recite such. It is further unclear if it is intended for the claims to comprise a different step(s) of determining physical properties of the unknown liquid and a pipette other than the prior “determining” steps recited in claim 1, then the claim should clearly recite such.
Furthermore, it is unclear what is required to be done by who or what to be considered as “multidimensional optimization” and “multistep optimization” because the claim does not provide for such. It is noted that what may be considered as “optimal” and “optimized” is relative, subjective. Here there is no clear and definitive indication of such recited in the claim.
As to claim 10, it is unclear what the pipette is not required to be wetted before because the claim does not recite such. There is no relative basis for to indicate “before” what?
As to claim 11, the term “and” appears to be missing at the end of the first paragraph. Furthermore, it is unclear where such steps are required relative to the steps of claim 1 because the claim does not recite such. Furthermore, it is unclear what is required to be done by who or what to perform the storing and assay procedure because the claim does not recite such.
It is unclear what is “a liquid class” because such is not clearly defined in the claim nor specification. Therefore, it is unclear what is required to be performed to perform “storing…” The phrase, liquid class, is subjective and the storing can be performed mentally.
The term “liquid class” in claim 11 is a relative term which renders the claim indefinite. The term “liquid class” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. What may be considered as a liquid class to one person may not be considered as such to another and vice versa. There is no indication as to how any liquid class is related to any physical parameters. However, a person can sort such parameters as desired. Including mentally in any liquid class as one desires.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.
Claims 1-11 are rejected under 35 U.S.C. 101 because
the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) steps of determining physical parameters of a pipette, the physical parameters including geometric parameters of the pipette, which at least include a tip radius of an orifice of the pipette and determining the physical parameters of the unknown liquid by minimizing an objective function depending on a difference between a simulated pressure curve and the measured pressure curve, which both can performed mentally. Therefore, this is an abstract idea.
This judicial exception is not integrated into a practical application because once the determining step is completed, nothing is done with the information from the determining steps. Therefore, there is no application much less a particular practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because although claim 1 recites measuring a measured pressure curve in the pipette during aspirating and/or dispensing. This is a conventionally known technique in the art for making a determination of if the pipette is operating properly as intended by for example, detecting for the presence of air bubbles, foam, clogging, etc. This is well understood, routine and conventionally known in the art.
The dependent claims 2-11 do not solve the issues of above. Viewing the limitations as a combination, the claim simply instructs the practitioner to compare and/or correlate information to make a subjective determination. When viewed either as individual limitations or as an ordered combination, the claims as a whole do not add significantly more to the abstract idea of using results/data to make a subjective determination.
Therefore, the claims are directed to abstract ideas. The claims are not patent eligible.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over, Zuppiger; Adi et al.; US 7,964,160.
Zuppiger discloses a method for determining physical parameters of an unknown liquid to be aspirated and/or dispensed by a laboratory automation device (implicit, see for example column 1, lines 34-38: "in the technical field of liquid handling, in particular with respect to pipetting fluids, there has long been a need to evaluate pipetted samples on the basis of predetermined quality criteria. Primarily, in the case of the automatic pipetting of fluids in microplates with for instance 96, 384 or 1536 wells, [ ... ]"), the method comprising:
determining physical parameters of the pipette (within "1 . Generation of a Simulated Curve": "the geometry of a disposable pipette tip"), the physical parameters including geometric parameters of the pipette, which at least include a tip radius of an orifice of the pipette (implicit);
aspirating and/or dispensing the unknown liquid with a pipette of the laboratory automation device and measuring a measured pressure curve in the pipette during aspirating and/or dispensing (At the end of this section: "Apparatus and methods for measuring a pressure characteristic curve in a pipetting apparatus have on the one hand been known for a long time (cf. e.g. U.S. Pat Nos. 4,340,390; 4,675,301; 4,794,085) and on the other hand have recently been patented (cf. e.g. U.S. Pat. No. 6,938,504)." and reference to "measured curve 41");
determining the physical parameters of the unknown liquid (acceptable or not as a pipetted liquid sample*) by minimizing a difference between a simulated pressure curve ("simulated curve 42") and the measured pressure curve, wherein the simulated pressure curve simulates a pressure in the pipette during aspirating and/or dispensing and is calculated based on a physical model of the laboratory automation device ("2. Fitting the Simulated Curve", first to fifth "approximation step") including the physical parameters of the pipette ("second approximation step[ ... ] takes the[ ... ] radius of the pipette tip into consideration").
It is noted that both of the terms "physical parameter" and "unknown" are vague and broadly interpretable. The claim does not specify what physical parameter is required to be determined and in what sense the liquid is "unknown". See also Claim Interpretations and 112 rejections above.
"Known", in the context of the application, does not necessarily mean something like: "it's blood" or "it's urine, since examples of physical parameters of unknown liquids to be determined are provided, for example in the last optional part of claim 5: "wherein the physical parameters of the unknown liquid (22) comprise at least one of a density, a viscosity, a surface tension and a wetting angle." See also Claim Interpretations and 112 rejections above.
Therefore, if "physical parameter" is interpreted as "suitability for pipetting" and "unknown liquid" is interpreted as "liquid of which it is unknown whether it is suitable for pipetting", then the methods as disclosed in 01 qualify as such.
Zuppiger does not disclose 1) curve fitting is done by minimizing an objective function; and the physical parameters of the unknown liquid are varied to minimize the objective function.
The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness.
In Zuppiger in a number of "approximation steps" (a first to a fifth), certain parameters are varied or "taken into account", which seems to have the effect of fitting certain parts of the "simulated curve 42" with the "measured curve 41 ". (column 7, lines 4-14).
Subsequently: "During pipetting various errors can occur that can be attributed to properties of the pipetted samples, the pipette tips and vessels used, and the pipetting apparatus employed. All these errors are manifested in the form of specific signatures or changes in the characteristic pressure or flow curves recorded. These signatures can therefore be used to detect and differentiate errors." (column 7, lines 28-34).
The "physical parameters of an unknown liquid" to be determined in Zuppiger ("suitability for pipetting", see the explanation above) is not varied in Zuppiger. In Zuppiger, many parameters can be changed (or "taken into account") during the first to fifth approximations.
The technical effect of these differences is that the determination of physical parameters is automated and simplified. Minimizing one objective function is easier to automate than performing 5 approximation steps (with possible iterations between them). Also, the physical parameter to be determined results from the best curve fit (which is what the minimization of the objective function amounts to): it is the physical parameter for which there is the best curve fit.
Therefore, it would have been obvious to and within the common sense, predictability, knowledge, and skill of one of ordinary skill in the art to define an objective function and then minimizing it to automate parameter determination.
Furthermore, for example, Zuppiger suggests to take "the viscosity of the sample" into consideration in the "third approximation step".
It is therefore considered to be an obvious step, starting from Zuppiger, to keep all other parameters constant, namely: sample density, the wetting contact angle and the presence of system liquid" of the first approximation step; aspiration rate and the radius of the pipette tip" of the second approximation step; "the static (diluter/plunger) friction" of the fourth approximation step; "the attenuation behavior of the system liquid" of the fifth approximation step; in order to determine the viscosity by varying the value of the viscosity and determining the value that provides the best curve fit, especially since Zuppiger already teaches an iterative approach: "It has also been shown that the simulated curve 42 can achieve a very good match between the iterative curve 43 and the actual measured pressure curve 41 by adjusting the physical parameters using the especially developed fitting routines.” (column 7, lines 9-14).
As to claims 10-11, it would have been obvious to and within the common sense, predictability, knowledge, and skill of one of ordinary skill in the art to employ a clean, unused pipette to avoid contamination and any step of using the unknown liquid can be considered as a part of an “assay procedure”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Keller; Michael et al.; Keller; Michael et al.; OTT; Philipp; Ingenhoven; Nikolaus et al.; INGENHOVEN; Nikolaus et al.; Kaplit; Michael; and Kureshy, Fareed et al. discloses pipetting device and methods of use.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798
