DETAILED ACTION
Non Final
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/17/2025 appears to be in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. It is noted that per MPEP 609.02 II.A.2. that
…when examining: (A) a continuation application filed under 37 CFR 1.53(b), (B) a divisional application filed under 37 CFR 1.53(b), or (C) a continuation-in-part application filed under 37 CFR 1.53(b). A listing of the information need not be resubmitted in the continuing application unless the applicant desires the information to be printed on the patent.
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.
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 19-38 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.
The following Claims recite limitations which have insufficient antecedent basis. The Claims and respective limitations include the following: Claims 19, 27 and 33 each recite “the method” in line 1; Claim 19, "each inlet hole" in line 6, "the molten thermally responsive substance" in line 7, "the respective valve channel" in line 7; Claim 23, "the microfluidic network" in line 1; Claim 27, "the bottom" in line 4, “each inlet hole” in line 6; Claim 38, "an upper surface" in line 2; Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 19, 21, 23-27, 33, 35-38 are rejected (as indefinitely understood) under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Parunak (US 6575188) (where it is noted that Parunak has a publication date (1/30/2003) at least 1 year earlier than the earliest date of filing of the instant application (that being 11/14/2005)) in view of Mileaf (US 5652149);
Claim 20 is rejected (as indefinitely understood) under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Parunak in view of Mileaf as applied to claim 19 (as indefinitely understood) above, and further in view of Colin (US 2003/0186295);
Claim 22, 30 is rejected (as indefinitely understood) under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Parunak in view of Mileaf as applied to claim 19 (as indefinitely understood) above, and further in view of Brown (US 5503803);
Claim 28, 29 is rejected (as indefinitely understood) under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Parunak in view of Mileaf as applied to claim 27 (as indefinitely understood) above, and further in view of Koesdjojo (US 8999265);
Claim 31 is rejected (as indefinitely understood) under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Parunak in view of Mileaf and Brown as applied to claims 27 and 30 (as indefinitely understood) above, and further in view of Koesdjojo;
Claim 32 is rejected (as indefinitely understood) under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Parunak in view of Mileaf as applied to claim 27 (as indefinitely understood) above, and further in view of McNeely (US 2004/0037739);
Claim 34 is rejected (as indefinitely understood) under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Parunak in view of Mileaf as applied to claim 33 (as indefinitely understood) above, and further in view of Parce (US 5885470.)
Parunak discloses in claim 19: A method of making a microfluidic cartridge (Col 2 ln 14-23 or Col 11 ln 38- Col 12 ln 46, figures 1, 12a-12c and see claims 11 and 12), the method comprising: providing a substrate comprising a plurality of inlet holes (as seen in figure 13a, there are multiple drilled holes for introduction of TRS into the channels including a reservoir channel via exemplary hole 40/1015, the channel/aperture must id and also see figures 11a-d as applicable to embodiment in figures 12a-c) on a top side of the substrate (40/1015 is on a top substrate side) and a plurality of valve channels on a bottom side of the substrate (the channels 1012, 1006/1008 and 1004 extend to the bottom side of the substrate), wherein a bottom layer (the bottom layer is best seen in figure 1 and…) is attached to the bottom side of the substrate to seal the plurality of valve channels; propelling (introducing TRS into a reservoir channel, the channel/aperture must have an inlet hole of sorts for the introduction of the TRS, see Col 8 ln 5-10) a quantity of molten thermally responsive substance into each inlet hole, wherein the molten thermally responsive substance is drawn into the respective valve channel by capillary action to form a valve (Col 11 ln 63 – Col 12 ln 30); and attaching a top layer to the top side of the substrate (a bonded quartz cover per Col 13 ln 50-52);
but Parunak does not explicitly disclose: the covering to seal the plurality of inlet holes; Mileaf teaches: attaching a label (50) over an inlet (48) as part of the top layer (Col ln 43-53), for the purpose of preventing accidental actuation of the reservoir or samples, and considering that Parunak teaches: forming the top substrate with a bonded quartz cover (as discussed above);
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing of the invention to provide Parunak as taught in Mileaf and discussed above, with a top substrate with a bonded quartz cover as well as a label that covers the inlet holes of Parunak as taught in Mileaf, all for the purpose of providing for fluid containment and contaminant free system.
Parunak discloses (as modified for the reasons discussed above) in claim 20: The method of claim 19, but does not disclose, although Colin teaches: the microfluidic cartridge is configured to process multiple samples in parallel (paragraph 0071, provided for the purpose of increasing processing throughput of multiple sample reactions.)
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing of the invention to provide in Parunak as taught in Colin, the microfluidic cartridge is being arranged to process multiple samples in parallel as taught in Colin, and all provided for the purpose of increasing processing throughput of multiple sample reactions.
Parunak discloses (as modified for the reasons discussed above) in claim 21: The method of claim 19, wherein the substrate comprises a plurality of amplification channels (each channel or chamber can be an amplification channel depending on the use Col 13 ln 30-35 and as arranged…) on the bottom side of the substrate.
Parunak discloses (as modified for the reasons discussed above) in claim 22: The method of claim 19, does not disclose, although Brown teaches: attaching a vent layer to the top side of the substrate (oleophobic vent layer 222 Col 8 ln 45-56, provided for the purpose of allowing air in the channel to escape and leave only the liquid in the channel, for accurate sampling.)
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing of the invention to provide Parunak as taught in Brown, attaching a vent layer to the top side of the substrate, such as taught in Brown, an oleophobic vent layer, and provided for the purposes of allowing air in the channel to escape and leave only the liquid in the channel, for accurate sampling.
Parunak discloses (as modified for the reasons discussed above) in claim 23: The method of claim 19, wherein all of the microfluidic network defining structures are defined on the substrate (as shown the substrate is formed as the integral defining structure, and see Col 13 ln 45-60.)
Parunak discloses (as modified for the reasons discussed above) in claim 24: The method of claim 19, wherein the top layer traps air used for valve actuation (air Col 12 ln 13-16 is used to displace the TRS.)
Parunak discloses (as modified for the reasons discussed above) in claim 25: The method of claim 19, wherein the bottom layer comprises a heat sealable laminate layer (Col 14 ln 22 – 50 where the heaters are formed as a second substrate layer and laminated/bonded to the first substrate layer.)
Parunak discloses (as modified for the reasons discussed above) in claim 26: The method of claim 19, Parunak/Mileaf teaches: attaching a label (50) as part of the top layer (Col ln 43-53), for the purpose of preventing accidental actuation of the reservoir or samples (all for the reasons as discussed above)
Parunak discloses in claim 27: A method of making a microfluidic cartridge (Col 2 ln 14-23 or Col 11 ln 38- Col 12 ln 46, figures 1, 12a-12c and see claims 11 and 12), the method comprising: providing a substrate comprising a plurality of inlet holes (as seen in figure 13a, there are multiple drilled holes for introduction of TRS into the channels including a reservoir channel via exemplary hole 40/1015, the channel/aperture must id and also see figures 11a-d as applicable to embodiment in figures 12a-c) and a plurality of valve channels (id); applying a laminate layer to the bottom of the substrate to cover the plurality of valve channels (Col 14 ln 22 – 50 where the heaters are formed as a second substrate layer and laminated/bonded to the first substrate layer); loading a thermally responsive substance into each inlet hole (introducing TRS into a reservoir channel, the channel/aperture must have an inlet hole of sorts for the introduction of the TRS, see Col 8 ln 5-10); and applying a strip to the top of the microfluidic substrate to cover the plurality of inlet holes (a bonded quartz cover per Col 13 ln 50-52); but but Parunak does not explicitly disclose: the covering to seal the plurality of inlet holes; Mileaf teaches: attaching a label (50) over an inlet (48) as part of the top layer (Col ln 43-53), for the purpose of preventing accidental actuation of the reservoir or samples, and considering that Parunak teaches: forming the top substrate with a bonded quartz cover (as discussed above);
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing of the invention to provide Parunak as taught in Mileaf and discussed above, with a top substrate with a bonded quartz cover as well as a label that covers the inlet holes of Parunak as taught in Mileaf, all for the purpose of providing for fluid containment and contaminant free system.
Parunak discloses (as modified for the reasons discussed above) in claim 28: The method of claim 27, but does not disclose, although Koesdjojo teaches: trimming the laminate layer (with a laser trimmer Col 18 ln 60-65 and then inspecting per Col 23 ln 27-35 the features with a microscope, for the purpose of production and meeting manufacturing tolerances.)
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing of the invention to perform for Parunak as taught in Koesdjojo trimming the laminate layer with a laser trimmer as taught in Koesdjojo and then inspect the features with a microscope, for the purpose of production and meeting manufacturing tolerances.
Parunak discloses (as modified for the reasons discussed above) in claim 29: The method of claim 27, the thermally responsive substance is loaded and that the laminate layer is adhered to the substrate (as discussed above, Col 8 ln 5-10); but Parunak but does not disclose: inspecting the substrate for adherence and application standards, although Koesdjojo (US 8999265) teaches: inspecting per Col 23 ln 27-35 the features with a microscope, for the purpose of production and meeting manufacturing tolerances.
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing of the invention to perform for Parunak as taught in Koesdjojo inspect the features with a microscope, for the purpose of production, adherence, application and for meeting manufacturing tolerances.
Parunak discloses (as modified for the reasons discussed above) in claim 30: The method of claim 27, does not disclose although Brown teaches: applying a hydrophobic vent membrane to the top of the substrate (oleophobic vent layer 222 Col 8 ln 45-56, provided for the purpose of allowing air in the channel to escape and leave only the liquid in the channel, for accurate sampling.)
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing of the invention to provide Parunak as taught in Brown, attaching a vent layer to the top side of the substrate, such as taught in Brown, an oleophobic vent layer, and provided for the purposes of allowing air in the channel to escape and leave only the liquid in the channel, for accurate sampling.
Parunak discloses (as modified for the reasons discussed above) in claim 31: The method of claim 30, further comprising the hydrophobic vent membrane is applied [and secured] to the substrate; but Parunak but does not disclose: inspecting the substrate for adherence and application standards, although Koesdjojo (US 8999265) teaches: inspecting per Col 23 ln 27-35 the features with a microscope, for the purpose of production and meeting manufacturing tolerances.
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing of the invention to perform for Parunak as taught in Koesdjojo inspect the features with a microscope, for the purpose of production, adherence, application and for meeting manufacturing tolerances.
Parunak discloses (as modified for the reasons discussed above) in claim 32: The method of claim 27, does not disclose, although McNeely teaches: stacking a plurality of microfluidic cartridges (ph 0146, provided for the purpose of minimizing space occupied by the cartridges/slides); Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing of the invention to provide Parunak as taught in McNeely, stacking a plurality of microfluidic cartridges as taught in McNeely and all provided for the purpose of minimizing space occupied by the cartridges/slides.
Parunak discloses in claim 33: A method of making a microfluidic cartridge (Col 2 ln 14-23 or Col 11 ln 38- Col 12 ln 46, figures 1, 12a-12c and see claims 11 and 12), the method comprising: providing a substrate comprising an inlet hole (as seen in figure 13a, there are multiple drilled holes for introduction of TRS into the channels including a reservoir channel via exemplary hole 40/1015, the channel/aperture must id and also see figures 11a-d as applicable to embodiment in figures 12a-c) on an upper surface (at 40/1015 is on an upper surface thereof) of the substrate and a valve channel on a lower surface of the substrate (the channels 1012, 1006/1008 and 1004 extend to the bottom side of the substrate), wherein a heat transfer layer is attached to the lower surface of the substrate (Col 14 ln 22 – 50 where the heaters are formed as a second substrate layer and laminated/bonded to the first substrate layer), wherein the heat transfer layer is configured to enable heat transfer from a heater (id) for operation of a valve; dropping a quantity of thermally responsive substance into the inlet hole (introducing TRS into a reservoir channel, the channel/aperture must have an inlet hole of sorts for the introduction of the TRS, see Col 8 ln 5-10) which flows by capillary action into the valve channel to form the valve (Col 11 ln 63 – Col 12 ln 30); and attaching an upper layer to the upper surface of the substrate (a bonded quartz cover per Col 13 ln 50-52);
but Parunak does not explicitly disclose: the covering to seal the plurality of inlet holes; Mileaf teaches: attaching a label (50) over an inlet (48) as part of the top layer (Col ln 43-53), for the purpose of preventing accidental actuation of the reservoir or samples, and considering that Parunak teaches: forming the top substrate with a bonded quartz cover (as discussed above);
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing of the invention to provide Parunak as taught in Mileaf and discussed above, with a top substrate with a bonded quartz cover as well as a label that covers the inlet holes of Parunak as taught in Mileaf, all for the purpose of providing for fluid containment and contaminant free system.
Parunak discloses (as modified for the reasons discussed above) in claim 34: The method of claim 33, wherein the substrate comprises a plastic (Col 13 ln 48, polymeric materials for substrate material); Parunak does not disclose: injection molding for portions of the substrate; but Parce teaches: injection molding for a polymeric substrate that provides for microfabrication and repeated manufacturing throughput (Col 5 ln 15-30);
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing of the invention to provide Parunak as taught in Parse with the substrate with at least portions of Parunak as taught in Parse being produced via injection molding for a polymeric portion of substrate all for the purpose of providing for microfabrication and repeated manufacturing throughput.
Parunak discloses (as modified for the reasons discussed above) in claim 35: The method of claim 33, wherein the substrate comprises a non-venting material (the material can be silicon or glass, Col 13 ln 45-55 and that can seal and not vent.)
Parunak discloses (as modified for the reasons discussed above) in claim 36: The method of claim 33, wherein the substrate comprises a low autofluorescence material (Col 14 ln 60 to Col 15 ln 5, using Topas material which has robust properties that are not as auto-fluorescent.)
Parunak discloses (as modified for the reasons discussed above) in claim 37: The method of claim 33, but does not disclose: the upper layer serves as a location for operator markings; but Mileaf (US 5652149) teaches: attaching a label (50) as part of the top layer (Col ln 43-53), for the purpose of preventing accidental actuation of the reservoir or samples and labeling of the device;
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing of the invention to provide Parunak as taught in Mileaf, with a top layer label, provided for the purpose of preventing accidental actuation of the reservoir or samples and labeling of the device.
Parunak discloses (as modified for the reasons discussed above) in claim 38: The method of claim 33, wherein the upper layer seals a plurality of inlet holes on an upper surface of the substrate.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW W JELLETT, whose telephone number is 571-270-7497. The examiner can normally be reached on Monday-Friday (9:30AM-6:00PM EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisors can be reached by phone. Ken Rinehart can be reached at (571)-272-4881, or Craig Schneider can be reached at (571) 272-3607. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Matthew W Jellett/Primary Examiner, Art Unit 3753