Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The limitations being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph are
control means in claims 1 and 11;
flow control means in claim 4;
means for analyzing in claim 13
Applicant discloses the control means in claims 1 and 11 to be one or several processors, for example microprocessors or microcontrollers (para. [0129]).
Applicant discloses the flow control means of claim 4 to be a pump (para. [0119]: Flow control means 15, here a pump immerged in the fluid reservoir 14).
Applicant discloses the means for analyzing are imaging, optical (such as optical microscopy), or spectroscopy techniques (para. [0072], [0082]).
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: optional means configured to measuring a pressure drop in claim 13 (optional means, as the name implied, is not a required feature of the claim or any of its dependents); and flow controlling means of claims 13 and 14 (flow controlling means is not a required feature in claim 13, and is structurally defined in claim 14).
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 1-15 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.
Regarding claims 1 and 15, the lines 19-20 of claim 1 and lines 14-15 of claim 15 recite “setting at least one temperature setting information selected from a target temperature and a target temporal temperature profile”. The claim limitation may raise clarity issue as it is unclear if the claim limitation requires at least one input/setting for both target temperature or temperature profile, or the limitation. “at least one temperature setting information” is referring to a closed list of alternatives of a target temperature or target temporal temperature profile. In this case, Examiner recommended applicant to uses phrases like “selected from the group consisting of”. For the purpose of examination, Examiner interpreted the claim limitation is reciting a closed list of alternatives.
Similar issue occurs in claim 6. The claim recites “the thermal conductive layer is chosen from a plate made of a rigid material and a layer made of a soft material”. The claim lacks clarity as it is unclear if the thermal conductive layer needed to be made of both a plate made of a rigid material and a layer made of a soft material, or the claim simply requires the conductive layer to be made of one of the materials. From page 9, lines 4-14 of the specification, the specification discloses the conductive layer simply needs to be made from one of the materials, so long the materials are conductive.
Claims 2-5 and 7-14 are also rejected for being dependent on claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1-6, 10-13, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Medoro (U.S. Pub. No. 2020/0055043 A1) as cited in IDS.
Regarding claim 1, Medoro discloses a system for controlling the temperature of a microfluidic chip (para. [0054]; microfluidic device 11, Fig. 2), said microfluidic chip being of the general form of a flat plate having two opposite main faces and in which is embedded at least one microchannel for receiving a substance, said system comprising:
a Peltier module (para. [0041]; heat pump 16 comprises (is) a Peltier cooler; Fig. 2) having a cold face and a hot face (features of every standard Peltier cooler) and connected to a power generator (para. [0042]: heat pump 16 (Peltier cooler) is designed to operate with a power of 5-8 Watt),
a thermal regulation device (para. [0044]: liquid heat exchanger 18, Fig. 2) having a thermal regulated face applied against one of the cold and hot faces of the Peltier module (Figs. 1 and 4)),
at least one temperature sensor (para. [0045]: temperature sensor 24, Fig. 1) positioned on the other face of the cold and hot faces of the Peltier module and being intended to be applied against one of the main faces of the microfluidic chip (See Fig. 1),
control means configured to control the power generator of the Peltier module depending on a temperature of the thermal regulation device (para. [0063]: the control device 30 adjusts the operation of the heat pump 16 according to the parameters detected by the sensor 24 (and by the sensor 25)) and at least one temperature setting information selected from a target temperature (para. [0063]: reference temperature), and to regulate a temperature of the face of the Peltier module provided with said at least one temperature sensor to said at least one temperature setting information (para. [0063]: control device 30 operates the heat pump 16),
and said system being provided with a through hole traversing the Peltier module and the thermal regulation device, said hole having an axis perpendicular to the faces in contact of these elements (see Fig. 4, right hand side: the through hole through items 16 and 18 for what seems to be a bolt).
Furthermore, Medoro discloses the optional feature of the optional thermal conductive layer (para. [0033]: heat transfer element 15) made of a thermal conductor material (para. [0033]: the element 15 comprises (is made of) a material designed to conduct heat) and within which is placed the temperature sensor (fig. 1), the thermal conductive layer being applied on the other face of the cold and hot faces of the Peltier module (fig. 2) and being intended to be applied against one of the main faces of the microfluidic chip (para. [0080]: element 15 is arranged in contact with the device 11),
and said system being provided with a through hole traversing the optional thermal conductive layer, said hole having an axis perpendicular to the faces in contact of the conductive layer (see Fig. 4, right hand side: the through hole through item 15 what seems to be a bolt).
Regarding claim 2, Medoro discloses the claimed system as discussed above in claim 1. Medoro discloses the cold face of the Peltier module is applied against the thermal regulated face of the thermal regulation device (See fig. 4).
Regarding claim 3, Medoro discloses the claimed system as discussed above in claim 1. Medoro discloses the thermal regulation device and the Peltier module have faces in contact of same dimensions and form (16 and 18 in fig. 4).
Regarding claim 4, Medoro discloses the claimed system as discussed above in claim 1. Medoro discloses the thermal regulation device include:
a fluid reservoir (para. [0044]) for storing a heat transfer fluid (radiator 20; fig. 1),
a thermal regulation element (heat exchanger 18, fig. 1) inside which a channel or a chamber is embedded, said channel or chamber being in fluid communication with said fluid reservoir (para. [0041], two ducts 21 and 22, which fluidically connect the heat exchanger 18 and the radiator 20; ducts 21, 22 fluidly connect items 18 and 20, fig. 1), one face of said thermal regulation element being the thermal regulated face applied against the hot face of the Peltier module (see fig. 4), said thermal regulation element being provided with a traversing through hole, the axis of which is perpendicular to the thermal regulated faces (see Fig. 4, right hand side: the through hole)
flow control means for controlling the flow rate of the heat transfer fluid within said channel (pump 23, fig. 1),
and the temperature of the thermal regulated device is the temperature of the fluid in the fluid reservoir (para. [0044]).
Regarding claim 5, Medoro discloses the claimed invention as discussed above in claim 4. Medoro discloses the thermal regulation element is made of a material chosen from copper (para. [0030]: The system 1 further comprises a regulating assembly 13, which comprises at least one regulating device 14 having at least one heat transfer element 15 arranged at (in particular, in contact with) the reservoir 6 to adjust the temperature of the reservoir 6...More precisely, the element 15 comprises (is made of) a material designed to conduct heat (in particular, metal; more specifically, copper).
Regarding claim 6, Medoro discloses the claimed system as discussed above in claim 1. Medoro discloses wherein, when present, the thermal conductive layer is chosen from a plate made of copper (para. [0033]).
Regarding claim 8, Medoro discloses the claimed system as discussed above in claim 1. Medoro discloses wherein, when present, the thermal conductive layer has a traversing hole in which is nested said at least one temperature sensor (see Fig. 2, item 15 and 24 in the same layer; see Fig. 4, right hand side: the through hole through item 15 what seems to be a bolt).
Regarding claim 10, Medoro discloses the claimed system as discussed above in claim 1. Medoro discloses wherein the through hole has a defined size and form (para. [0081]; Advantageously but not necessarily, the regulating device 14 (more precisely, the element 15) has a through opening (a hole) 42.).
Regarding claim 11, Medoro discloses a temperature controlled microfluidic assembly comprising:
a microfluidic chip of the general form of a flat plate having two opposite main faces (para. [0054]: microfluidic device 11), and in which is embedded at least one microchannel for receiving a substance (Fig. 6),
at least one temperature controlling system according to claim 1 (see claim 1), the face of the Peltier module thereof provided with said at least one temperature sensor being applied against one of the main faces of the microfluidic chip (See fig. 1).
Regarding claim 12, Medoro discloses the claimed assembly as discussed above in claim 11. Medoro discloses wherein said face of the Peltier module recovers at least partly a monitoring area of the main face of the microfluidic chip (interpreted as the area of contact of the microfluidic chip and Peltier module, see fig. 1).
Regarding claim 13, Medoro discloses a microfluidic apparatus (para. [0058]: apparatus 12) for monitoring a substance present in a microfluidic chip (para. [0054]; microfluidic device 11, Fig. 2) of the general form of a flat plate having two opposite main faces and in which is embedded at least one microchannel for receiving the substance (para. [0054]), comprising
at least one temperature controlling system according to claim 1, the face of the Peltier module thereof provided with said at least one temperature sensor being intended to be applied against one of the main faces of the microfluidic chip (See claim 1),
means for analyzing the substance within said at least one microchannel (para. [0056]: separation unit comprises a system chosen from the group consisting of…optical tweezers…),
control means for controlling said at least one temperature controlling system (para. [0063]: control device 30) and said analyzing means (para. [0055] - [0059]).
Regarding claim 15, Medoro discloses a method for monitoring a substance using the microfluidic apparatus of claim 13, and a microfluidic chip of the form of a flat plate having two opposite main faces and in which is embedded at least one microchannel for receiving the substance, comprising:
placing one main face of the microfluidic chip in contact with the face of the Peltier module of said at least one temperature regulating system provided with said at least one temperature sensor (See 16 and 18 in fig. 4 being assembled and in contact with chip 11 of fig. 1).,
introducing said substance inside said at least one microchannel before placing the microfluidic chip or after connecting said at least one microchannel of the microfluidic chip to said at least one fluidic circuit (para. [0030]),
setting the temperature of the thermal regulation device at a first value (para. [0035]: In particular, the regulating assembly 13, by means of the regulating device 14, which acts, in use, via the element 15, is designed to adjust the temperature of the reservoir 6 (more specifically, so as to maintain the temperature of the reservoir 6 within a given range); para. [0037]: It has been experimentally and surprisingly observed that by controlling the temperature of the liquid in the reservoir 6 it is possible to obtain a more reliable, accurate and reproducible movement of the particles.),
setting at least one temperature setting information selected from a target temperature (para. [0063]: reference temperature) for the temperature of the face of the Peltier module of said at least one temperature regulating system provided with said at least one temperature sensor (para. [0063]: control device 30 operates the heat pump 16),
regulating the temperature of the face of the Peltier module of said at least one temperature regulating system provided with said at least one temperature sensor to said at least one temperature setting information by controlling the power generator of the Peltier module (paragraphs [0081]-[0082]),
monitoring the substance using means for analyzing the substance (separation unit 3) (separation unit comprises a system chosen from the group consisting of…optical tweezers. Para. [0056]) within said at least one microchannel during the temperature regulating step (para. [0064]).
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Medoro.
Regarding claim 7, Medoro discloses the claimed system as discussed above in claim 1. Medoro discloses wherein, when present, the thermal conductive layer has a thickness, measured perpendicularly to the face of the Peltier module against which it is applied (fig. 1: items 15 and 24).
Medoro does not disclose the conductive layer has equal or substantially equal to a thickness of said at least one temperature sensor. It is known in the art that heat transfer conduction is modeled by Fourier’s Law:
Q
=
k
A
Δ
T
L
Wherein Q is the heat transfer rate, k is the conductivity, A is the surface area, T is the temperature difference, and L is the thickness of the material. As the heat transfer rates are variables that can be modified, among others, by adjusting the material thickness, with heat transfer rate both increasing as the material thickness is decreased, the precise thickness of both sensor and the thermal conductive layer would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed equal or substantially equal thickness cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the sensor and conductive layer thickness in Medoro to obtain the desired balance between the heat transfer rates of the sensor and conductive layer (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), with increasing heat transfer rates allow the heat to transfer to the sensor faster, since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Claim(s) 9 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Medoro in view of Cappi (U.S. Pub. No. 2020/0353467 A1).
Regarding claim 9, Medoro discloses the claimed invention as discussed above in claim 1. Medoro does not explicitly disclose the temperature sensor is a resistance temperature detector. In an analogous art, Cappi discloses a biological sample processing device (2, fig. 1) comprising temperature sensors integrated with a base structure/plate, heating unit, and/or heat transfer unit, wherein the device is configured to measure the temperature of a microfluidic device (8, fig. 1c) (para. [0083]). Furthermore, Cappi discloses the temperature sensor may comprise various sensors per se well known in the art, with a preferred embodiment being a resistive sensor (para. [0083]). It would have been obvious to one of ordinary skill in the art before the effective filing date to have incorporated a resistive sensor to the device of Medoro based on the disclosure of Cappi, as Cappi discloses one of ordinary skill in the art have flexibility in selecting temperature sensor (with preference to resistive sensor) so long the sensor forms part of a temperature control system configured to control the operation of the thermal unit (para. [0083]).
Regarding claim 14, Medoro discloses the claimed invention as discussed above in claim 13. Medoro discloses a fluidic circuit (para. [0028]) connected to a microchannel of the microfluidic chip and an actuator for controlling the flow of the fluid (paragraph [0028]: actuator 7; fig. 1) but does not disclose a flow controlling means chosen from a flow monitor, a flow meter, a pressure monitor, and a pressure sensor.
In an analogous art, Cappi discloses a biological sample processing device (2, fig. 1) comprising temperature sensors integrated with a base structure/plate, heating unit, and/or heat transfer unit, wherein the device is configured to measure the temperature of a microfluidic device (8, fig. 1c) (para. [0083]). Furthermore, Cappi discloses the reservoir system/fluid feeding system can be controlled by a control system comprising a pressure sensor such as a manometer (para. [0161]).
Since Medoro have already disclosed a flow control system using an actuator, it would have been obvious to one of ordinary skill in the art before the effective filing date to have incorporate a flow or a pressure sensor (as taught by Cappi or other arts in similar field) to the flow actuators system of Medoro to derive the claimed invention. Doing so provide a pressure/flow rate reading to the actuators to better regulate the fluid transfer of the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICKEY HUANG whose telephone number is (571)272-7690. The examiner can normally be reached M-F 9:30-5:30 PM ET.
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/M.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758