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
Claims 1 – 8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected method, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11 November 2025.
Applicant's election with traverse of Group II in the reply filed on 11 November 2025 is acknowledged. The traversal is on the grounds that the amended claims would not cause a serious search or examination burden. This is not found persuasive because the two inventions are directed to different statutory categories.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 20 February 2023 and 29 August 2024 were filed. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9 – 19 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as based on a disclosure which is not enabling. The disclosure does not enable one of ordinary skill in the art to practice the invention without undue experimental determination of the fluidic line diameter, fluidic line length, fluidic line orientation, fluid plug length, air plug length, and fluid composition, which are critical or essential to the practice of the invention but not included in the claims. See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976). MPEP 2164.01(a) outlines the Wands factors as means to assess whether any necessary experimentation required by the specification is “undue.”
With regards to independent claim 9;
Factor A (the breadth of the claims);
The preamble of independent claim 9 merely recites “an in-vitro diagnostic analyzer”, which has a broadest reasonable interpretation encompassing everything from a handheld blood glucose meter to a benchtop laboratory device and which potentially extends to a flow-through analyzer in an industrial chemical pipeline. The additional structural features of a sensor located in a flow-through sensor path, a fluid supply comprising a deoxygenated calibration fluid, a fluid-selection valve, a fluidic line, and a controller do not meaningfully limit the breadth of the claims. The specification of the instant invention recites that a fluidic line “can be a hollow conduit such as a tubing, a channel, a chamber […] which can have any shape and size” (see [0026]), and as such does not limit the scope of the analyzer.
Factor B (the nature of the invention);
The claimed invention is directed to the aeration of a liquid slug/plug, a problem which has been significantly researched in the fields of fluid dynamics. The problem of liquid slug aeration is of particular relevance to commercial pumping, including oil transport, commercial water infrastructure, and pipeline reagent transport in industrial chemistry.
Factor C (the state of the prior art); Factor D (the level of one of ordinary skill in the art); Factor E (the level of predictability in the art);
In a 2003 article, Bonizzi and Issa identify key parameters affecting the entrainment of gases in horizontal fluidic lines (A copy of this document has been provided with this office action). Bonizzi and Issa identifies surface tension as a key fluid property affecting how gases enter the fluid slug (Page 1687, paragraph 4, “Hence, surface tension is an important factor in the break-up of the interface between the elongated bubble and the slug front (Fabre and Line, 1992).”). Bonizzi and Issa likewise identify fluid viscosity as a key property (see page 1688, paragraph 5). Page 1688 identifies several proposed empirical models for air entrainment in liquid slugs, including models dependent on fluid line diameter.
In a related study, Brauner and Ullman 2004 (attached with this action) identify key features affecting aeration including surface tension (page 243, paragraph 1); liquid and gas slug length (page 248, section 2.5); and fluidic line diameter and orientation (page 261, section 4.4).
Bonizzi and Issa also acknowledge the unpredictable role of fluid line geometry in slug aeration (Page 1688, paragraph 6, “Most, if not all, of the available correlations for the average slug void fraction in liquid slugs were found to be unsatisfactory when applied to different geometries from those used in extracting the empirical correlations (Paglianti et al., 1992).”; Section 6.2 on page 1712 begins a discussion on V-sections and undulations in pipes, and the impact of incline on gas entrainment).
Factor F (the amount of direction provided by the inventor); Factor G (the existence of working examples);
With regards to the fluidic line length, diameter, and orientation, the specification of the instant invention merely recites that a fluidic line “can be a hollow conduit such as a tubing, a channel, a chamber […] which can have any shape and size.” (see [0026]). No mention of the fluid line’s orientation (i.e., whether the fluid line is arranged horizontally, vertically, or coiled) is made in the instant specification.
With regards to the fluid plug length, the instant specification recites that a smaller volume of calibration fluid is preferred due to faster oxygenation and that the fluid plug should be long enough to cover the sensor path (see [0043]). No further details are provided or preferred volumes/lengths given.
With regards to the air plug lengths, no details are provided in the instant specification. The entire head and tail of the fluid line may be filled with air, but the scope of the claim encompasses an embodiment with fluid bracketing either side of the air plugs. No details are provided in the specification to the length, volume, or pressure of air required to keep the fluid plug isolated from other materially in the fluidic line. Additionally, no description is given about managing pressure in the fluidic line. Is an upstream check valve required to let in additional air when the pump switches direction, or is a vacuum created within the line as the fluidic plug oscillates? These limitations are of special concern with regards to the orientation of the fluidic line, as a line which includes inclined or looped sections may require backpressure to keep the fluid plug from sliding downwards.
With regards to the fluid composition, the instant specification defines a fluid as “either a gas or liquid or mixtures thereof. A fluid may be for example a sample, a reference fluid […], a cleaning fluid, a wetting fluid, air, or other gas.” Independent claim 9 specifically recites “a deoxygenated calibration fluid,” which is identified in the specification as “a reference or standard solution” (see [0031]). Taken together, these limitations are quite broad, and encompass the deoxygenated calibration fluid being a gaseous mix, an aqueous fluid, an oil, or a fluid with a surfactant. Given the importance of surface tension and viscosity on the aeration of a fluid, it is not clear how one of ordinary skill in the art would adapt the disclosed invention to meet the physical requirements of a given calibration fluid.
The disclosure of the current invention does teach that the fluid velocity is critical to oxygenation, and that the fluid velocity must be managed so as to avoid breaking up the liquid plug (see [0046]). Other than teaching that a “predefined speed limit” should be set, no details are provided on the pumping mechanics or means by which the formation of large bubbles or foam within the fluid plugs could be avoided. One of ordinary skill in the art will recognize that, even if the fluid plug is still coherent, the presence of a gas bubble or foam could interfere with the sensor (especially an optical sensor).
Factor H (The quantity of experimentation needed to make or use the invention based on the content of the disclosure);
A person of ordinary skill in the art would have to first ascertain the composition of the calibration fluid and its physical properties. Then, based on the scale of the device and the properties of the fluid, such a person would need to determine the diameter and orientation of the fluidic line, as well as the surface properties of the fluidic line with respect to surface tension. Once these experimental determinations are complete, further experimentation would be needed to find the appropriate length of the fluid and air plugs with respect to the fluidic line diameter and orientation, followed by additional experimentation to find the appropriate velocity (and acceleration) of the fluid plug to allow it to travel without generating large bubbles or foam. Once all of these determinations are completed, such a person would still need to determine the number of oscillations required to oxygenate the calibration fluid.
Conclusion;
These experimental determinations encompass major factors of all of the positively recited structural features of the device. Given this, and in light of the subject matter’s innate requirement for standardized and reproducible results (an imprecise quality control feature cannot perform its function), the disclosure of the current application is not enabling.
Claims 10 – 19 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as based on a disclosure which is not enabling due to their dependence on claim 9. These claims do not recite any further structural features which address the deficiencies discussed above.
Allowable Subject Matter
Claims 9 – 20 encompass subject matter which is allowable over the prior art.
The following is a statement of reasons for the indication of allowable subject matter:
Pfeiffer et al (US 20150079685 A1) teaches that calibration fluid can be equilibrated with ambient air, by oscillating a flexible bag. However, Pfeiffer et al does not disclose any pumping along a length of fluidic line, or two zones of ambient air.
Samsoondar (US 20220091148 A1) teaches the use of air bubbles to separate regions of a calibration fluid in a fluidic line, but does not teach any oscillation or oxygenation of the calibration fluid.
Ismagilov et al (US 20060003439 A1) teaches the use of fluid plugs to transport fluids within a microfluidic system, but teaches away from the inclusion of oxygen into the fluid plugs.
Troughton et al (US 20110120206 A1) teaches methods of calibrating sensors with deoxygenated calibration fluid, and that any oxygenator known in the art can be used to reach a desired oxygen concentration. However, it does not teach the use of a calibration fluid plug, or oscillation of the fluid plug.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON CLAIRE GERHARD whose telephone number is (571)270-0945. The examiner can normally be reached M-F, 9:00 - 5:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (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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/ALISON CLAIRE GERHARD/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797