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 .
Response to Arguments/Amendments
Applicant's arguments filed September 22, 2026, have been fully considered but they are not persuasive.
The claims have not been amended to over each of the prior 112 rejections.
As to claim 44, applicant states:
“In regard to claim 44, the Examiner contends it is allegedly unclear if "a workspace surface" is intended to be an element of the invention, as reciting the prior claimed base is located on a workspace surface does not require such workspace surface to be an element of the system. Applicant respectfully submits the workspace surface is not a structural component, but rather is intended to describe directional motion in the X-direction and the Y-direction. The workspace surface, as used in claim 44, simply means a surface the prior claimed base is disposed upon. Reconsideration is respectfully requested.”
It is noted that applicant states that the workspace surface is not a structural component of the invention. However, the claim clearly recites the base is disposed upon the workspace surface. Therefore, the claim is clearly defining the invention relative to the workspace surface and requiring the base to be located on the workspace surface. Therefore, the claim is contradictory to the workspace surface not being structural element of the claim. The issue could be remedied either claiming the system comprise a workspace surface… or deleting the recitation directed to such and defining the X-Y plane relative to a horizontally extending upper surface of the previously claimed base. Such as the X-Y plane is parallel to a horizontally extending upper surface of the base.
As to the new matter rejection of claim 34, applicant no longer asserts the claim is supported by paragraph 0048 (which does not support the claim as indicated in the prior Office Action). Applicant now states:
“Claim 34 finds support in, at least, paragraphs [0064], [0065], and [0069] of the Specification as filed. Paragraph [0064] establishes there is a "first motor configured to cause the plunger to move upward or downward relative to the syringe body." Paragraph [0065] then establishes the automated pipettor sends "command instructions to the first motor to cause the plunger to move downward relative to the syringe body." It follows that the automated pipettor is therefore also capable of sending command instructions to the first motor to cause the plunger to move upward relative to the syringe body. Claim 34 depends from claim 1, which recites the controller sends one or more commands to at least one of the first motor to actuate the plunger or the second motor to actuate the syringe in response to a determination made using analysis of the received air pressure measurements. The Specification provides literal support for "preventing the automated pipettor from aspirating any liquid" (para. [0069]) in response to analysis of pressure data from the pressure sensor. Thus, if the controller sends commands to the first motor to control movement of the plunger, and the automated pipettor is preventing aspiration of any liquid, it follows that the controller may send at least one command to prevent the plunger from moving upward or downward relative to the syringe body. A person of ordinary skill in the art would understand this, and thus be enabled to make and use the invention according to claim 34.”
The examiner disagrees. As admitted by applicant, none of the referenced paragraphs of the originally filed specification and originally filed claims describe or recite the controller is programmed to send at least one command to the first motor to prevent the plunger from moving upward or downward relative to the syringe body. Instead, applicant is asserting that what one opines as what way may be, could be understood (inferred, assumed, presumed, etc.) from the disclosure entitles applicant to claim such. The examiner disagrees. The only mention of any commands directed to preventing anything is that directed to preventing aspiration. The claim is not constituent with the specification. Therefore, for reasons previously stated in the prior Office Action and those herein, the new matter rejection is hereby maintained.
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 does not disclose each and every limitation of amended independent claims 1 and 42. Specifically, Muller does not disclose a controller programmed to receive air pressure measurements from a pressure sensor, analyze the received air pressure measurements to determine, based on a change in air pressure within the syringe, at least one of that the pipette tip is contacting a liquid in a container, a level of the liquid in the container, a volume of the liquid in the container, and a time at which the pipette tip contacts the liquid in the container, and send one or more commands to at least one of the first motor to actuate the plunger or the second motor to actuate the syringe in response to determination, as recited in claim 1. Nor does Muller disclose a controller in communication with a pressure sensor and programmed to receive air pressure measurements from the pressure sensor, analyze the received air pressure measurements to determine based on a change in air pressure within the syringe, that the pipette tip is contacting a liquid in a container and send one or more commands to at least one of the first motor and the second motor to aspirate at least a portion of the liquid from the container, as recited in claim 42.
The Examiner contends Muller discloses a controller using pressure data to determine when a pipette tip is in contact with a sample liquid (Office Action, p.15). The Examiner, however, misrepresents the cited paragraph of Muller. The paragraph reads "when the pipette tip is in contact with a sample liquid and as the piston or plunger moves up, air pressure in the tip is lowered and a liquid sample is pushed into a pipette tip by the atmospheric pressure. Deviations from this standard curve can detect errors related to functions of pipette tip, such as a clogged tip during aspiration based on a pressure threshold for clots and incomplete aspiration of a liquid sample into a pipette tip based on a pressure threshold for insufficient liquid in a pipette tip" (para. [OSS]). Muller teaches that pressure measurements while aspirating a liquid can be used to determine if there are any issues. This is not equivalent to a controller programmed to use pressure measurements while not aspirating a liquid to determine that a pipette tip is contacting a liquid in a container. The use of pressure measurements as taught by Muller assumes the pipette tip is contacting a liquid, and therefore cannot anticipate a controller determining if a pipette tip is contacting a liquid.”
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 “programmed 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 be programmed to use pressure measurements while not aspirating a liquid to determine that a pipette tip is contacting a liquid in a container 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. “For example, when the pipette tip is in contact with a sample liquid and as the piston or plunger moves up, air pressure in the tip is lowered and a liquid sample is pushed into a pipette tip by the atmospheric pressure”. (paragraph 0055). Therefore, when the air pressure measured in the device is lowered, it is determined that the pipette tip is in contact with the sample liquid.
Therefore, Muller does disclose a controller “programmed 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.
Furthermore, it is noted that analyzing pressure changes to determine contact of a tip with a liquid (and other determinations) is not a novel and nonobvious technique in the art. For example, as exemplified by Obi; Hiroshi et al., US 5,158,748; determination of liquid level as in Atake US 4,780,833; Bjornson; Torleif Ove et al., US 7,479,391; Kilmer, US 5,665,601 and other prior references.
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.
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”))
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.
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.
As to claims 37, 39, 42, and 44-45, it is noted that a Z-axis, X-axis, and Y-axis and X-Y plane are not structural elements of the inventions 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.
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 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.
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).
Claim 45 is rejected via dependency upon a rejected claim.
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 (programmed 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
