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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 4, 2026 has been entered.
Response to Arguments/Amendments
Applicant's arguments filed June 4, 2026 have been fully considered but they are not persuasive.
It is noted that applicant has amended the claims, but still does not specify where each of the amendments (individually) are supported within the original filed specification. Therefore, the examiner again hereby requests that applicant provide for the specific text that supports each and all amendments.
The claims appear to be directed to new matter because the examiner fails to locate any description/support for each of the amended or claims. For example, the examiner fails to locate any description of the controller being configured to send at least one command to the first motor to prevent the plunger from moving upward or downward relative to the syringe body. The recitation of paragraph 0048 of the publication relied upon by applicant, “the apparatus might be further configured to prevent the automated pipettor from aspirating any liquid when a series of pressure spikes exhibits a lack of a regular repetition pattern” does not support claim 34. The passage makes no mention of a controller, the controller sending at least one command, first motor, plunger, nor any prevention of moving the plunger upward or downward. Therefore, such is considered as new matter.
As to the 112(b) rejections directed to claims 28-31, 33-35, 37, 39, and 45, applicant states:
“Claims 28-31, 33-35, 37, 39, and 45 refer to the controller, which is a component of the system. The controller is programmed to execute one or more commands. Applicant respectfully requests consideration of the function of the controller. "There is nothing inherently wrong with defining some part of an invention in functional terms... [and] a functional limitation must be evaluated and considered, just like any other limitation of the claim, for what it fairly conveys to a person of ordinary skill in the pertinent art in the context in which it was used. "MPEP § 2173.05(g).”
The examiner disagrees. It is noted that the section of the MPEP referenced by applicant specifically refers to “means-plus-function” language, which is not what is being employed in the instant claims. Although the claims are directed to a controller, the claims do not provide for any further structural elements of the controller. The “configured to” clauses are directed to what the controller can possibly do, is structurally capable of doing (if certain conditions occur, certain pressure measurements are made during use). However, it is noted that also that “configured to…” does mean nor is the same as “programmed to” as asserted by applicant. Changes in pressure measurements (values) are just that…changes in pressure values (regardless of what may cause such pressure changes). Reciting the phrase “configure to…” before each and every possible use of a controller does not necessarily provide for any further structure of the controller, nor is such a structural distinction from any other controller (computer).
Here, the claims are directed to an apparatus (system) not a process of use. There is no requirement for the system (apparatus) to be used in any method including with any unclaimed container, liquid, nor anything else such that any pressure changes (including pressure spikes) occur in the pipette tip. A conventionally known computer is structurally capable of receiving data (pressure values) from a pressure sensor and analyzing such measurements to determine pressure changes and subsequently indicating/determining what such pressure changes can be considered as correlated with, indicating, and/or meaning.
As to the 112 (b) rejection directed to the term “substantially equal” in claim 29, applicant asserts:
Here, the specification provides such guidance, describing peaks that are "identical to each other within a first predetermined threshold error value (which might include, but is not limited to ... a threshold error value in a range between about 1 ms to about 500 ms)" (Specification, para. [0080]). Thus, the specification provides an objective standard for determining what constitutes "substantially equal" with respect to the peaks, such that one of ordinary skill in the art would be reasonably apprised of the scope of the invention. Accordingly, the claim is not indefinite.
The examiner disagrees. Paragraph {0080] does not provide for a clear and definitive definition that states “substantially means…; “substantially equal means”; nor “substantially equal period means”. Even if were on to rely upon such, it is noted that the phrase “which might include, but is not limited to:” does not provide for any clear and definitive values. Furthermore, the paragraph provides for a list of alternative value ranges (none are required, but “might be included”) that include the subjective, relative term “about”. Therefore, the paragraph of the specification relied upon by applicant as being asserted as providing for what is definitively meant by “substantially equal periods” is also subjective. Therefore, the examiner maintains that term as employed in the claim is relative, subjective, and indefinite.
As to the slope, applicant asserts “when the rise and run correspond to physical quantities with units, such as pressure (mbar) and time (seconds), the resulting slope inherently carries units to reflect that ratio (i.e., mbar/s), and therefore is not dimensionless.”
The examiner disagrees. Applicant assertion contradicts the known definition of “slope” (a ratio of same units) and the known mathematical concepts (of division). A slope is a dimensionless value…it is ratio. When a ratio is formed from two quantities measured in the same units, the resulting ratio is dimensionless — it has no units. Therefore, the examiner maintains the previously stated position.
As to the 102 rejection based upon Muller, US 2020/0023351, applicant states:
“Muller fails to teach or suggest a controller configured to determine one or more of contact between a pipette tip and a liquid, liquid level, liquid volume, or timing of contact between a pipette tip and a liquid based on a change in air pressure measured by a pressure sensor, and much less configured to send one or more commands to a motor(s) in response to such a determination. Muller is directed to a fluid-tight flow system for processing liquid samples using pumps and microfluidic components. The system of Muller uses pressure- readings to determine flow rate without any additional sensor components (para. [0056]). Muller does not disclose any controller programmed to receive and analyze pressure changes to make determinations regarding pipette tip interaction with a liquid in a container, nor does it disclose a controller programmed to direct motor operations in response to such determinations.”
The examiner disagrees. The argument does not provide for any structural distinction between the language of the claims (positively claimed structural elements) and the teachings of Muller. The argument is directed to the “configured to” clauses as directed to the broad, structurally undefined controller. Furthermore, the argument is not commensurate in scope with the claim language because the controller is not claimed as, required to comprise any program nor be programmed to do anything as asserted by applicant.
However, Muller discloses the same and/or equivalent structural elements provided for in the claims. Including Muller discloses system including a controller 100, e.g. embodied in a computer. The controller 100 may be embodied in one or more computers, microprocessors or microcomputers, microcontrollers, programmable logic controllers, field programmable gate arrays, or other suitably configurable or programmable hardware components. The controller 100 may comprise control software, firmware, hardware or other programming instruction sets programmed to receive user inputs, and control instrument motors (e.g. pipettor arm drive motors such as X- and Y-drive motors; pipetting channel Z-drive motor; and pipetting drive motors 310, and 311); as well as provide for real-time feedback control according to embodiments of the present disclosure. (paragraph 0006, 42, 44-45, and described further throughout the reference, and shown in Figure 1B).
The controller 100 may comprise a non-transitory computer readable medium, stored in the memory device, and programmed to receive data from the first pressure sensor in real-time and data from the second pressure sensor in real-time, and adjust command of at least the first pump of the first automated pipetting channel or the second pump of the second automated pipetting channel to adjust a flow rate within the microfluidic chip using real-time feedback based on said data from the first pressure sensor and second pressure sensor. The controller 100 may comprise control software, firmware, hardware or other programming instruction sets programmed to receive data from instrument sensors (e.g. pressure sensors 314 and 315), receive user inputs, conduct analyses based on pressure data, and adjust control of the pump(s) of the automated pipetting channel(s). (paragraph 0046)
Muller further discloses that the pressure sensors monitors air pressure in the pipette tip and such air pressure data can be correlated with specific events based upon pressure values including, but not limited to: when the pipette tip is in contact with a sample liquid. (paragraph 0055).
Therefore, Muller does disclose a controller “configured to” make a determination of the pipette tip contacting a liquid based upon air pressure measurements/changes in the pipette tip.
Therefore, the prior art rejection is hereby maintained.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 structural 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 structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
It is noted that the claims mention a change in pressure measured (pressure of what, not specified), pressure spikes, periods, pressure peaks, Z-axis, container, X-axis, and Y-axis. All of such are materials/articles intended to be, can be worked upon. However, it is noted that pressure (including measured pressure values, pressure spikes, pressure peaks, periods, slope of pressure values, etc.) is not structure. Although a container is mentioned in claims 1 and 42, such container is not claimed as an element of the invention. There is no requirement for any broad, unspecified “container” to be present.
It is noted that the claims are directed to apparatuses. However, the claims are replete with language directed to intended, possible use and process steps that do not provide for structural elements of the apparatus. There is no requirement for the apparatus to be used in any method, to perform any method steps. There is no requirement for any pressure values/change in pressure value of anything to be measured, and for such to provide for nor include any spikes, peaks, periods, slope values, etc. Furthermore, there is no requirement for any moving of anything nor dispensing of anything to be performed.
The “configured to…” and similar such clauses are directed to intended, possible uses/process steps. There is no requirement for any steps to be performed to measure any pressure values of anything. There is also no requirement for any moving of anything along any structurally undefined axis (not claimed as structural element of the apparatuses). The claims are directed to apparatuses defined by the positively claimed structural elements, listed in the body of the claims not by any process of use (including possible pressure values).
It is noted that the phrases “in connection with” and “in communication with” do not provide for any specific connection/communication (does not preclude a non-physical connection/communication (“wireless”))
Although, no pressure change is ever required to occur nor be measured, it is noted that the claims do not specify what change in pressure of what is intended to be/can be measured.
It is noted that the phrase “at least one” only requires one.
It is noted that the phrase “at least two” only requires two.
It is noted that terms ending in “s” (such as; “spikes”; “peaks” etc.) only require two.
The term “or” is directed to alternative, options.
The controller is not a mechanical structure that can provide for any actuation (actions). The controller can send signals to specific elements of the automated pipettor such as the first and second motors to provide for (mechanical actuation) movement via other structures (actuators, screws, etc. ), the controller alone cannot actuate (move) the base, syringe, and pressure sensor as implied by the claims. It is noted that he specification and drawings provide, describe a number of structures required to perform movements of structures. However, the claims do not positively claim all of such disclosed/illustrated structures.
As to claim 41, it is note that “a position” is not required to be any structure (any location in space, air) where the container is stationary is relative to the base anything else. If applicant intends for the container to be located on some specific structure of the base, then the claim should clearly recite such.
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 28-31, 33-35, 37, 39, 41, and 44-45 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 what is further structurally required by claims 28-31, 33-35, 37, 39, 41, and 45 because the claims do not provide for any additional structural elements of the invention/apparatus nor any further structure of any prior positively claimed structural elements. The phrase “the controller is configured to…” in are directed to possible intended functions of the controller. There is no requirement for any actuation of anything to ever be performed.
Claims 28-31 are directed to possible, potential “air pressure measurements” and possible, potential “pressure peaks” that could occur be measured but such are not structure and do not structurally define the controller. Whether or not the apparatus is used such that any change in pressure of anything occurs (and such pressure change/values provide for that as recited in the claims) is a matter of choice, not requirements.
The term “substantially equal” in claim 29 is a relative term which renders the claim indefinite. The term “substantially equal” 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. It is unclear what are “periods” and how any pressure peaks that are not structure comprise periods because the claims (29-30) do not specify/define such. Furthermore, there is no indication as what variances from actually being equal are considered as “substantially equal” because the claim does not provide for such. What may be considered as substantially equal periods to one person may not be considered as such by another and vice versa.
As to claim 34, although no moving of the plunger nor anything is ever required to be performed, it is unclear what is structurally meant, required by the phrase “the controller configured to clause” because what is intended to be, can be prevented also does not structurally define the invention/apparatus. The examiner fails to locate any description of that recited in new claim 34 within the originally filed specification. Therefore, the claim is directed to new matter.
As to claims 37, 39, 42, and 44-45, it unclear if a Z-axis, X-axis, and Y-axis and X-Y plane are intended to be structures and structural elements of the inventions because the claims do not positively claim such as structural elements and such are not defined as being any specific structures. It appears that such are referring to intangible imaginary lines, planar geometrical spaces. However, it is noted that each of such are not specified, nor limited to any specific lines/directions. Although no movement along any axes is required to be performed along any structures nor imaginary lines, it is noted that one can label/name any movement direction as one desires and any movement of anything is relative to any other structure of the apparatuses (including the structurally undefined, “base”) and any other structure.
As to claim 41, it is unclear if applicant is intending claim, require the container to be located on the base or in some structural element of the base. A position relative to the base does not require such. Any location where the container is stationary is a position (in space or anything) that is “relative” to the base.
As to claim 44, it is unclear if “a workspace surface” is intended to be an element of the invention and what is structurally required to define such because the claim does not clearly recite such. Reciting the prior claimed base is located on a workspace surface (not previously claimed, and not structurally define) does not require such workspace surface to be an element of the system (nor any prior positively claimed element of the system).
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 34 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The examiner fails to locate any description of claim 34. See prior remarks and rejections above.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 28-31, 33-35, 37, and 39-45 is/are rejected under 35 U.S.C. 102(a)(1),(a)(2) as being anticipated by Muller et al., US 2020/0023351.
Muller discloses an apparatus comprising a deck 350 (base) supporting a microchip 440 (container); an automated pipettor 001; a pipette tip 316, 317 is attached to the automated pipettor; and a pressure sensor 314, 315 in fluid communication with the pipette tip. The apparatus further comprises controller 100 may control parameters of the pipetting instrument 001 such as, timing of movement and X, Y, Z positions of instrument arms 302 and 303, timing and control of pipetting drive motors 310 and 311 such as to control fluid flow rates of a liquid sample through a microfluidic chip (container).
The pumps of the automated pipetting channels are pistons or plungers 308 and 309 in communication with pipetting drive motors 310 and 311 (first motor) and pressure sensors 314 and 315. In one embodiment, the pressure sensors 314 and 315 are integrated into the pipetting channels 312 and 313 (syringe bodies).
The system further includes X- and Y-drive motors to position pipetting channel 1 and 2, each comprising a pipette tip, over the inlet and outlet ports of a microfluidic chip (step 520), command the z-drive motors to move pipetting channel 1 and 2 down to engage the pipette tips with the inlet and outlet ports of the microfluidic chip, respectively. (second, third, and fourth motos; paragraphs 0052, 54).
The controller 100 (controller) can transmit control signals or other instructions to electrical or electromechanical system components (e.g. such as motors or drives, servos, actuators, racks and pinions, gearing mechanisms, and other interconnected or engaging dynamic parts) via communication technologies to enable data communication (e.g. serial or Ethernet connections, Universal Serial Bus (USB), Institute of Electrical and Electronics Engineers (IEEE) Standard 1394 (i.e., “FireWire”) connections, wireless data communications technologies such as BLUETOOTH™ or other forms based upon infrared (IR) or radio frequency (RF) signals. (see the entire reference, including paragraphs 0045-48, all figures and descriptions of such).
The controller 100 may comprise a non-transitory computer readable medium, stored in the memory device, and programmed to receive data from the first pressure sensor in real-time and data from the second pressure sensor in real-time, and adjust command of at least the first pump of the first automated pipetting channel or the second pump of the second automated pipetting channel to adjust a flow rate within the microfluidic chip using real-time feedback based on said data from the first pressure sensor and second pressure sensor. The controller 100 may comprise control software, firmware, hardware or other programming instruction sets programmed to receive data from instrument sensors (e.g. pressure sensors 314 and 315), receive user inputs, conduct analyses based on pressure data, and adjust control of the pump(s) of the automated pipetting channel(s). (paragraph 0046)
Muller further discloses that the pressure sensors monitors air pressure in the pipette tip and such air pressure data can be correlated (via the controller) with specific events based upon pressure values including, but not limited to: when the pipette tip is in contact with a sample liquid. (paragraph 0055).
The reference discloses the same and/or structural equivalents of all of the positively claimed structural elements recited in the claims and is structurally capable of performing all of the recited intended uses, steps of the claims.
Claims 28-31 are directed to the measured pressure that is not a structural element. The system of Muller is capable of providing for such pressure values.
As to claim 33-35, 37, 39, the plunger and syringe can be moved as or not moved unless desired to be moved at the appropriate time in the desired directions.
As to claim 40, as noted above, Muller discloses the controller 100 can transmit control signals or other instructions to electrical or electromechanical system components (e.g. such as motors or drives, servos, actuators, racks and pinions, gearing mechanisms, and other interconnected or engaging dynamic parts) via communication technologies…(paragraph 0047).
As to claim 41, see deck 350 (base) supporting a microchip 440 (container) and further containers. (paragraphs 0042, 44; Figures 1A, 1B).
As to claims 42 and 44-45, all of the elements of the claims are disclosed in the reference as noted above.
As to claim 43, the system comprises a frame in connection with the automated pipettor (Figure 1B).
Conclusion
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..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798
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