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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/12/2025 has been entered.
Remarks
This office action fully acknowledges Applicant’s remarks and amendments filed on 12 November 2025.
Claims 14-26 are pending.
Claims 1-13 are cancelled.
No claims are withdrawn.
No claims are newly added.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "262" and "224" have both been used to designate the “sealable inlet microfluidic channel” ([0076]), and the “inlets of the lightbulbs” ([0078]). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are further objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “224” has been used to designate both the “lightbulb” ([0074]) and “inlets of the lightbulbs” ([0078]). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Applicant is advised to further review the specification to ensure each reference numeral refers to only a single element of the device so as to avoid future drawings objections on further examination.
Specification
The amendment filed 11/12/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: Claim 17 is amended to recite “the inlet microfluidic channel is fluidly connected upstream within the cartridge via a region microfluidic channel” and Claim 18 is amended to recite heat sealing “disconnecting the lightbulb from the region microfluidic channel”. However, the specification does not mention a “region microfluidic channel”.
Applicant is required to cancel the new matter in the reply to this Office Action.
The amendment filed 11/12/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: Claim 14 and its dependents recite “a microfluidic lightbulb”. However, the specification does not mention a “microfluidic lightbulb”. While the specification does teach lightbulbs 224, the microfluidic lightbulbs are not present and do not appear to be a standard term of art. – See further the 35 USC 112 section below regarding the term “lightbulb”.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 14-26 are 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 claims require “the inlet microfluidic channel is fluidly connected upstream within the cartridge via a region microfluidic channel”; however, the instant specification does not mention a region microfluidic channel connecting the inlet channels upstream.
Applicant asserts these limitations are provided for by para. [0076] for Claim 17; however, para. [0076] does not provide for “the inlet microfluidic channel is fluidly connected upstream within the cartridge via a region microfluidic channel”. Further, Applicant asserts these limitations are provided for by para. [0078] for Claim 18; however, para. [0078] does not provide for the region microfluidic channel, instead merely stating “the microfluidic channel running within the qPCR lightbulb quantitative region 222” and remaining as failing to provide for the required “upstream” arrangement. Applicant may wish to refer to this “region microfluidic channel” as feeding each of the inlet channels and name it instead merely as “a microfluidic channel” in accordance with the instant specification.
Further, the amended claims require “a microfluidic lightbulb”; however, while the instant specification mentions “lightbulbs”, the specification does not mention “a microfluidic lightbulb”, and the term does is not a standard term of art, and such amended recitation is drawn to new matter.
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 14-26 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 14-26, where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999).
The term “microfluidic lightbulb” in the claims is used to mean channels and chambers as in Claim 14, while the accepted meaning of lightbulb is “a device used to convert electricity into light, consisting of a source of illumination,” and wherein microfluidic is construed to fluidic elements (i.e. channels, chambers) that are of micron-dimensions. The term is indefinite because the specification does not clearly redefine the term.
Does Applicant intend to recite this as a particular chamber within the device that is oval in shape (i.e. resembling a lightbulb’s shape)?
Regarding Claim 14, the claim recites in relevant part, “the chamber 110 connected to the lightbulb chamber is shaped to maximize a compartment volume”, rendering the claim indefinite. In microfluidic systems, compartment volume depends on the overall dimensions of the chip. Because the chip size is not recited, there is no single determinable “maximum” volume. Different designers could reasonably arrive at different geometries, all allegedly “maximized” (being a relative term), resulting in unclear claim boundaries. Applicant may wish to specify the particular dimensional relationships that cause the compartment volume to be maximized.
Regarding Claim 19, the claim recites “the cartridge receivable by the automated microfluidic system” wherein “the cartridge” lacks antecedent basis as it is merely inferentially recited in Claim 14 as a prospective structure containing the lightbulb. Further, the “automated” aspect is unclear given that no automation means/steps are provided. Further, it is unclear as to how the automated system is a microfluidic system given that Applicant provides the cartridge as a closed system in the amended Claim 14, thereby precluding microfluidic interfacing therewith.
Regarding Claim 23, where applicant acts as his or her own lexicographer to specifically define an uncommon/unofficial term of a claim, the written description must clearly define the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so define that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999).
The term “cater isolation membrane” in Claim 23 appears to be used by the claim to mean “a fluid permeable, gas impermeable membrane.” However, the phrase “cater isolation” does not appear to be a term of art, and the specification does not clearly define the term, thus rendering it is indefinite.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Hu et al. (US 2017/0167981 A1), hereinafter “Hu”, in view of Battrell et al. (US PAT 9,895,692 B2), hereinafter “Battrell”.
Regarding Claim 14, Hu teaches a microfluidic lightbulb of a cartridge (Fig. 1 shows the silicon cartridge/chip 102 housing the microfluidic lightbulb components. – Examiner further notes that the “a cartridge” is not a positively recited element of the claim and is merely a prospective workpiece incorporating the specifically claimed lightbulb.), comprising:
an inlet microfluidic channel 106 (Fig. 1 and [0033]: “The sample, be it for example blood plasma, some biological liquid, or some fluid chemical, is deposited into microfluidic channel branch 106 where it travels down until it meets the nanopillars 112 wherein the biomolecules are sorted.”),
a lightbulb chamber (the chamber holding biomolecules 116 as seen through Fig. 1) connected to the inlet microfluidic channel (Fig. 1 shows the lightbulb chamber connected to the inlet channel via the nanopillars channel 112.), wherein the lightbulb chamber is configured to receive a liquid and perform thermal-controlled amplification reactions while preventing bubble trapping (Fig. 1 shows the lightbulb chamber containing biomolecules 116 under analysis is connected to chamber 110 which comprises an outlet port which allows gas to escape, thereby reducing bubble trapping within the device. -- Further, the lightbulb chamber of Hu is fully capable of “perform[ing] thermal controlled amplification reactions”, as in Applicant’s amendments, in as much as is claimed given its commensurate structure as in the instant claims as a chamber to receive a liquid.),
and a chamber 110 connected to the lightbulb chamber, wherein the chamber 110 connected to the lightbulb chamber is shaped to maximize a compartment volume (Chamber 110 is commensurately shaped to maximize its volume on the microfluidic chip to an appropriate and desired level.), and configured to hold and retain compressed air from lightbulb chamber (Given the commensurate arrangement of channels, chambers, and fluid flow of Hu as in the instant Claim 14, the chamber 110 is interpreted as “configured to hold and retain compressed air due to inflow of liquid to the lightbulb chamber” given that it receives flow from the lightbulb chamber, thereby displacing and compressing air.),
thereby reducing pressure build-up within the microfluidic lightbulb of the microfluidic enclosed system and preventing bubble generation (As such pressure is caused as air is displaced as in Hu, as discussed above, the arrangement of Hu is interpreted as commensurately achieving reduced pressure build-up in the system for preventing bubble generation.),
as in Claim 14.
Further regarding Claim 14, Hu does not specifically teach the microfluidic lightbulb discussed above wherein the cartridge is configured as a microfluidic enclosed system for thermal-controlled amplification reactions, as in Claim 14.
However, Battrell teaches a respective sample testing cartridge 100 (Fig.s 1A and 4) comprising channels, chambers, and optical detection areas similar to that of Hu; wherein the cartridge of Battrell is further configured as a fully enclosed system comprising all of the components needed to prepare the sample for optical analysis (Abstract: “all dried and/or liquid reagents necessary for the assay are contained in the cartridge and the assay requires only the addition of sample”). Further, Battrell discusses the benefit of this arrangement as helping improve accuracy/repeatability and reducing contamination risks (col. 1, line 35).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Hu as a microfluidic enclosed system, such as suggested by Battrell, so as to achieve the discussed benefits of helping improve accuracy/repeatability and reducing contamination risks.
Further, while the device of Hu is fully capable of use in thermal-controlled amplification reactions (the lightbulb chamber being configured to perform thermal amplification reactions in as much as is claimed), Battrell additionally discusses the use of its microfluidic cartridge in thermal-controlled amplification/PCR reactions (col. 2, line 12). Such a modification of Hu to include the self-containment of Battrell thereby additionally resulting in a device specifically capable of use in thermal-controlled amplification reactions.
Examiner further notes that the claim does not positively require the cartridge, said cartridge merely being inferentially recited as a prospective containment system of the lightbulb. As such, the enclosed system is not actually required. However, solely to promote compact prosecution, Examiner has provided the combination of references above to provide for the enclosed microfluidic system.
Regarding Claim 16, the prior art meets the limitations of Claim 14 as discussed above. Further, Hu does not specifically teach the microfluidic lightbulb discussed above wherein the chamber connected to the lightbulb chamber is upside down spade shaped, as in Claim 16.
However, mere change in shape absent evidence to criticality, non-obviousness, or unexpected results associated with the claimed shape is an obvious matter of design choice – see MPEP 2144.04(IV)(B). Herein, one skilled in the art would find it obvious that the instant device having the claimed upside down spade shaped chamber would not function differently than the prior art device having a rectangular shaped compartment; absent evidence of criticality or unexpected results associated with the upside down spade shape of the instant claimed chamber.
Further, one of ordinary skill in the art would find it obvious to optimize through routine experimentation the size and shape of the chamber connected to the lightbulb chamber so as to appropriately permit a desired flow pattern through the device.
Claims 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hu in view of Battrell, as applied to Claims 14 and 16 above, and in further view of Song et al. (US 2007/0280857 A1), hereinafter “Song”.
Regarding Claim 15, the prior art meets the limitations of Claim 14 as discussed above. Further, Hu does not specifically teach the microfluidic lightbulb discussed above wherein an upper interior surface of the lightbulb chamber is round shaped to prevent bubble trapping, as in Claim 15.
However, Song teaches a respective microfluidic biological sample analysis device comprising analysis chambers which are round shaped so as to prevent bubble trapping ([0011]: “According to various embodiments, the at least one sample chamber may include a physical modification that is configured to control the movement of the meniscus of a biological sample as it loads the chamber and substantially hinder or prevent the entrapment of a gas bubble within the chamber. “ -- [0093]: “...in various embodiments, the portion of the chamber where the lateral surface portions meet the bottom surface may be rounded rather, for example as depicted in FIG. 3A, rather than meeting at a sharp, 90 degree angle.”), wherein this arrangement reduces error related to refraction of incident light for optical analysis through entrapped bubbles.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the microfluidic lightbulb of Hu wherein an interior surface of the lightbulb chamber is round shaped to prevent bubble trapping, such as suggested by Song, so as to reduce error related to refraction of incident light for optical analysis through entrapped bubbles; and would have a reasonable expectation of success therein.
Regarding Claim 17, the prior art meets the limitations of Claim 14 as discussed above. Further, Hu does not specifically teach the microfluidic lightbulb discussed above wherein the inlet microfluidic channel is fluidically connected upstream within the cartridge via a region microfluidic channel, as in Claim 17.
However, Battrell teaches a branching flow fed by a region microfluidic channel to feed each of the microfluidic “circuits” of the cartridge so as to performed multiplexed analysis (Fig. 14A and col. 21, line 16). Additionally, song teaches a commensurate arrangement wherein a main region channel 26 feeds a plurality of inlet channels 22 as seen through Fig. 1.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Hu wherein the inlet microfluidic channel is fluidically connected upstream within the cartridge via a region microfluidic channel, such as suggested by Song/Battrell, so as to provide a system capable of multiplexed analysis and sorting so as to achieve its processes simultaneously under variable conditions.
Further regarding Claim 17, Hu does not specifically teach the microfluidic lightbulb discussed above wherein the inlet microfluidic channel is sealable by heat, as in Claim 17.
However, Song teaches a respective microfluidic biological sample analysis device comprising channels and analysis chambers, wherein said channels and chambers are sealed/sealable to prevent fluid from leaking from the device ([0067]: “...a pressure sensitive adhesive film, laminated to the device so as to cover and seal fluid in the channels and chambers from leaking out of the device.”).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the microfluidic lightbulb of Hu wherein the inlet microfluidic channel is sealable by heat, such as suggested by Song, so as to reduce contamination due to leaks.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Hu in view of Battrell and Song, as applied to Claims 15 and 17 above, and in further view of Kim et al. (US 2018/0043360 A1), hereinafter “Kim”.
Regarding Claim 18, the prior art meets the limitations of Claim 17 as discussed above. Further, Hu does not specifically teach the microfluidic lightbulb discussed above where the inlet microfluidic channel is sealable by a sealing line, wherein the sealing line is configured to produce heat to melt and seal off the inlet microfluidic channel, thereby disconnecting the lightbulb from the region microfluidic channel, as in Claim 18.
However, Kim teaches a respective microfluidic device comprising channels with inlets and outlets, wherein the channel inlets and outlets are sealable by a sealing line configured to heat the inlet/outlet microfluidic channels and melt them to provide a sealing to the microfluidic channels ([0009]: “The sealing device may include: a support unit on which the microfluidic chip is arranged; and a heat-sealing unit for sealing an inlet unit and an outlet unit of the microfluidic chip by applying heat to the inlet unit and the outlet unit.”), wherein this arrangement prevents fluid from leaking or evaporating from the device ([0005]), thereby reducing error related to undesired fluid flow or evaporation. – As the device of Hu/Battrell commensurately provides inlet channels fed by a region channel, such melting of the inlet channel would commensurately cause isolation of the lightbulb from the region channel.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the microfluidic lightbulb of Hu where the inlet microfluidic channel is sealable by a sealing line, wherein the sealing line is configured to produce heat to melt the inlet microfluidic channel, thereby sealing the inlet microfluidic channel and disconnecting the lightbulb from the region microfluidic channel, such as suggested by Kim, so as to prevent fluid from leaking or evaporating from the device, thereby reducing error related to undesired fluid flow or evaporation; and would have a reasonable expectation of success therein.
Claims 19-22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Jovanovich et al (US 2011/0005932 A1), referred to hereinafter as “Jovanovich”, in view of Hu and Battrell. Hu and Battrell have been discussed above.
Regarding Claim 19, Jovanovich teaches an automated microfluidic system for detecting multiple different analytes in a single run ([0004]: “Advantages include…full automation to eliminate operator variances.” – [0153]: “…multiple analytes may be captured by combining affinity reagents or by using multiple modes of capture either on one type of bead or by mixing multiple bead or particle types.”) comprising:
a remote computer system ([0160]: “A computer module comprises computer executable code for processing and/or analyzing the data.” – [0160] “The system can be further configured to access the Internet, transmit data to an off-site server and receive information from the server.”),
a microfluidic analyzer connected with the remote computer system having an illumination source and a detection module ([0433]: “The temperature control device 400 can also have a detector 410. The detector can detect optical detection such as absorbance… The detector can comprise a light source…”); and
a cartridge receivable by the automated microfluidic system ([0024]: “In another aspect, the invention provides a system comprising: (a) a pneumatic assembly comprising: (i) a pneumatic manifold adapted to removably engage the cartridge on the fluidic side…”),
a sample tank and at least one reagent tank ([0022-0023]: “In another aspect, this invention provides a system comprising: a disposable cartridge comprising at least one set of fluidic chambers including a sample chamber… and a reagent card comprising reagents for performing a chemical reaction… wherein the card comprises a plurality of reagent chambers comprising reagents…”), as in Claim 19.
Further regarding Claim 19, Jovanovich does not specifically teach the automated analyzer discussed above wherein the cartridge has a plurality of the lightbulbs of Claim 14, as in Claim 19. – Note further the 35 USC 112 section above.
However, Hu/Battrell teaches a respective microfluidic cartridge for biodetection wherein an on-chip light source provides excitation light; and describes the benefit of this assembly as providing light precisely to the sensing region to detect the biomolecules of interest ([0025]), as in Claim 14 discussed above.
Further, while Hu teaches a single on-chip light source, and the instant claims require multiple light sources, mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see MPEP 2144.04(VI)(B). Herein, given that Jovanovich is drawn to parallel multiplexed analysis in microfluidic capillaries, one of ordinary skill in the art would find it obvious to provide a light source to each capillary where analysis takes place so as to precisely deliver light to each capillary.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the automatic analyzer taught by Jovanovich with a plurality of on-chip lightbulbs, such as suggested by Hu, so as to provide a structure which precisely delivers light to the sensing region of the device, thereby improving sensitivity and accuracy of the analysis; and would have a reasonable expectation of success therein.
Regarding Claim 20, the prior art meets the limitations of Claim 19 as discussed above. Further, Jovanovich teaches the automated analyzer discussed above wherein the detection module comprises a camera ([0029]: “In another embodiment, the photodetector comprises a CCD camera.”), as in Claim 20.
Regarding Claim 21, the prior art meets the limitations of Claim 19 as discussed above. Further, Jovanovich does not specifically teach the automated analyzer discussed above wherein the cartridge comprises spaces to hold up to 40 respiratory pathogens, as in Claim 21.
However, mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see MPEP 2144.04(VI)(B). Further, Jovanovich teaches multiplexed analysis wherein multiple samples are run in parallel and/or multiple analytes are detected ([0148]: “The instrument can comprise a plurality of parallel fluidic circuits by which fluidic operations can be performed in parallel.”).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the automatic analyzer cartridge of Jovanovich by merely duplicating the number of detection capillaries, such as to provide 40 capillaries to test for 40 different samples/analytes as claimed, so as to provide a structure capable of testing for and detecting the desired number of samples/analytes.
Further, limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). Thus, the use of the claimed invention for detecting respiratory pathogens does not confer novelty given that the device of Jovanovich is commensurately capable of testing for bacterial and viral pathogens which may or may not be of respiratory origin ([0199]: “In one embodiment the infectious agent is a bacteria, virus, fungi, mycoplasm or prion.”).
Regarding Claim 22, the prior art meets the limitations of Claim 19 as discussed above. Further, Jovanovich teaches the automated analyzer discussed above wherein the cartridge further comprises an extraction module ([0218]: “FIG. 53 shows a sample extraction module comprises a cartridge mated to a microfluidic chip.”), as in Claim 22.
Further regarding Claim 22, Jovanovich does not specifically teach the automated analyzer discussed above wherein the extraction module contains an elongated teardrop shaped chamber, as in Claim 22.
However, mere change in shape absent evidence to criticality, non-obviousness, or unexpected results associated with the claimed shape is an obvious matter of design choice – see MPEP 2144.04(IV)(B). Herein, one of ordinary skill in the art would find obvious that the claimed elongated teardrop extraction chamber and the prior art rectangular extraction chamber would not function differently from one another, thereby representing an obvious matter of design choice.
Regarding Claim 24, the prior art meets the limitations of Claim 19 as discussed above. Further, Jovanovich teaches the automated analyzer discussed above wherein the cartridge further comprises RT-PCR chamber ([0064]: “FIG. 27 shows detection of E. coli by immunomagnetic separation, followed by alkaline lysis and PEG-facilitated capture on magnetic beads, and analyzed by real-time PCR.” – As Jovanovich contemplates real-time PCR, the reaction chambers of the cartridge of Jovanovich are fully capable of being used for real-time PCR, wherein this recitation is further merely drawn to an intended use. Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II).), as in Claim 24.
Further regarding Claim 24, Jovanovich does not specifically teach the automated analyzer discussed above wherein the RT-PCR chamber comprises a U- shaped chamber, as in Claim 24.
However, mere change in shape absent evidence to criticality, non-obviousness, or unexpected results associated with the claimed shape is an obvious matter of design choice – see MPEP 2144.04(IV)(B). Herein, one of ordinary skill in the art would find obvious that the claimed U-shaped rtPCR chamber and the prior art circular reaction chamber would not function differently from one another, thereby representing an obvious matter of design choice.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Jovanovich in view of Hu and Battrell, as applied to Claims 19-22 and 24 above, and in further view of Coursey et al. (US 2015/0182966 A1), hereinafter “Coursey”.
Regarding Claim 23, the prior art meets the limitations of Claim 22 as discussed above. Further, Jovanovich/Hu does not specifically teach the device discussed above wherein the elongated teardrop shaped chamber further comprises a cater isolation membrane and a debubbler, wherein the cater isolation membrane is configured to capture nucleic acid, as in Claim 23.
However, Coursey teaches a respective microfluidic device comprising a gas-permeable, liquid-impermeable isolation membrane made of hydrophobic material to contain a liquid sample and isolate from air on the other side of the membrane, wherein said membrane is coupled with a vent port, a type of debubbler, so as to allow gas bubbles to escape the device, thereby reducing error associated with trapped bubbles ([0080]). – As the membrane is impermeable to liquid, it is configured to capture nucleic acid.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Jovanovich/Hu such that the extraction module further comprises a cater isolation membrane and a debubbler, such as suggested by Coursey, so as to allow gas bubbles to escape the device, thereby reducing error associated with trapped bubbles.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Jovanovich in view of Hu and Battrell, as applied to Claims 19-22 and 24 above, and in further view of Jones et al. (US PAT 9,767,343 B1), hereinafter “Jones”.
Regarding Claim 25, the prior art meets the limitations of Claim 24 as discussed above. Further, Jovanovich/Hu does not specifically teach the device discussed above wherein a slope is disposed at each ends of the chamber, as in Claim 25.
However, Jones teaches a respective microfluidic device wherein the edges of chambers contain therein are sloped to prevent bubble trapping ([col. 16, line 50]: “The chamber 405 may have asymmetrical sloped walls 484 and 491 to promote mixing of the sample and reagent and for removing bubbles from the mixture.”), thereby reducing error related to trapped bubbles.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the device of Jovanovich/Hu with a slope disposed at each end of the chamber, such as suggested by Jones, so as to reduce bubble trapping and thereby reduce error related to trapped bubbles; and would have a reasonable expectation of success therein.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Jovanovich in view of Hu and Battrell, as applied to Claims 19-22 and 24 above, and in further view of Arlett et al. (US 2018/0015474 A1), hereinafter “Arlett”
Regarding Claim 26, the prior art meets the limitations of Claim 19 as discussed above. Further, Jovanovich/Hu does not specifically teach the device discussed above wherein the cartridge further comprises a plug, wherein fluidic movements within the cartridge are realized by the vertical movements of the plug, as in Claim 26.
However, Arlett teaches a respective microfluidic cartridge comprising channels and chambers having one or more apertures covered by a fluid-impermeable membrane, wherein an outer actuator depresses the membrane through said aperture, thereby sealing off the channel/chamber, this valve mechanism being the “plug” ([0019]: “a first actuator mechanism for actuating the first valve membrane portion and a second actuator mechanism for actuating the second valve membrane portion”), wherein this arrangement allows for more precise control over fluid flow within the device, thereby reducing error due to improper flow patterns.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Jovanovich/Hu wherein the cartridge further comprises a plug, wherein fluidic movements within the cartridge are realized by the vertical movements of the plugs, such as suggested by Arlett, so as to provide for more precise control over fluid flow within the device, thereby reducing error due to improper flow patterns; and would have a reasonable expectation of success therein.
Response to Arguments
35 USC 112
Applicant’s amendments sufficiently overcome the rejection of Claims 16-26 as indefinite under 35 USC 112b, excluding that of Claim 23 reciting “a cater isolation membrane”. As such the rejection of Claims 16-26 under 35 USC 112b is hereby withdrawn, and that of Claim 23 is maintained. Regarding Claim 23, Examiner maintains that the term “cater isolation membrane” in Claim 23 appears to be used by the claim to mean “a fluid permeable, gas impermeable membrane.” However, the phrase “cater isolation” does not appear to be a term of art, and the specification does not clearly define the term, thus rendering it is indefinite. Applicant may wish to amend the claims to merely recite “an isolation membrane”. Additionally, upon further consideration, Examiner has set forth the rejection of Claims 14-26 as indefinite under 35 USC 112b for the additional reasons discussed above in the body of the action.
35 USC 102
Claim 14
Applicant’s arguments are on the grounds that the device of Hu is allegedly drawn to sorting molecules by size, thereby addressing a different technical problem than the present claimed invention. Applicant further alleges that Hu fails to teach the claimed channels and chambers as specifically claimed and being configured for thermal amplification reactions.
Applicant’s arguments are not persuasive because the prior art does not need to solve the same technical problem as the claimed invention so long as it teaches or suggests the claimed structure or would have been reasonably pertinent to one skilled in the art. When an apparatus is claimed, its patentability is based on the structure of the apparatus and not on the function it performs or the field in which it is applied – see MPEP 2111.02(II). Additionally, the device of Hu is used for analysis (Abstract: “The information from the optical detector can be analyzed further by connecting the microchip to a mobile computing device with its own processing abilities or abilities via the internet or cloud.). Further to this end, the device of Hu is fully capable of use in thermal amplification reactions; and the prior art of Battrell specifically provides for the cartridge used for thermal amplification/PCR. As discussed above in the body of the action, the combination of Hu and Battrell teaches each and every aspect of Claim 14.
Thus, Examiner sets forth the rejection of Claim 14 under 35 USC 103 as unpatentable over Hu in view of Battrell, as discussed above in the body of the action and as necessitated by Applicant’s amendments requiring the cartridge system be an enclosed system.
35 USC 103
Claim 14
Applicant further alleges that the use of Hu under 35 USC 103 is improper as Hu is allegedly a non-analogous device to the present invention.
Applicant’s arguments are not persuasive because Hu is analagous to the present invention as a microfluidic device comprising channels and chambers for performing fluid analysis, as discussed above. As Applicant acknowledges, MPEP 2141.01(a) states the reference is analagous if “the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem)”. The device of Hu and the present invention are of the same field of endeavor, being drawn to respective microfluidic devices of commensurate structure, and solve the same problem of liquid analysis.
Applicant again alleges that Hu does not teach the elements as claimed by the instant Claim 14. However, Applicant’s arguments are not persuasive because, as discussed above in the body of the action, the combination of Hu and Battrell teaches each and every aspect of Claim 14.
Claim 15
Applicant’s arguments are on the grounds that Song allegedly does not teach the upper interior surface of the lightbulb as round shaped. However, Applicant’s arguments are not persuasive because Song provides a chamber that is entirely round-shaped, thus satisfying the Claim 15 requirement that the upper interior surface of the lightbulb chamber be round shaped. Thus, Examiner maintains the rejection of Claim 15 under 35 USC 103.
Claim 16
Applicant’s arguments are on the grounds that the upside-down spade shaped compartment is critical to the function of the device, that said shape provides the unexpected benefits of enhancing bond strength of the cartridge layers. Applicant submitted a Declaration under 37 CFR 1.132 stating that the upside-down spade shaped compartment did not result in delamination of the sealed cartridge layers, whereas the rounded square/rectangular chambers resulted in delamination.
Applicant’s arguments are not persuasive because Applicant’s provided change in geometry between the rounded square/rectangular chambers to the upside down spade shaped chamber increases the contact area between the laminate film and the substrate, thereby increasing the adhesion/seal integrity as highlighted by the figure submitted with Applicant’s declaration and reproduced below.
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A person of ordinary skill in the art would reasonably expect improved adhesion, reduced peel initiation, and better sealing when the laminate is sealed over a wider contact area as shown above. Such a change in adhesion area represents a result-effective variable affecting sealing performance, and would thus be obvious to optimize by one of ordinary skill in the art. Thus, such effects would have been expected by one of ordinary skill in the art, as increased bonding area is a known factor influencing seal integrity. Accordingly, the results shown in the declaration are considered predictable consequences of routine optimization of compartment geometry representing no more than a mere non-critical change in chape respective to that of the prior art of Hu. Thus, Examiner maintains the rejection of Claim 16 under 35 USC 103.
Claim 17
Applicant’s arguments are on the grounds that neither Hu nor Song teaches the amended Claim 17 recitation "the inlet microfluidic channel is fluidly connected upstream within the cartridge via a region microfluidic channel, and wherein the inlet microfluidic channel is sealable by heat".
Applicant’s arguments are not persuasive because Battrell, incorporated into the rejection as necessitated by Applicant’s amendments, teaches a feeding “region channel” feeding a plurality of branching channels, wherein one skilled in the art would find it obvious to provide this arrangement to the device of Hu to allow for multiplexed analysis. Further, song teaches a main channel 26 feeding a plurality of inlet channels 22 for multiplexed and/or multiple analysis.
Thus, Examiner sets forth the rejection of Claim 17 under 35 USC 103 as unpatentable over Hu in view of Battrell and Song, as discussed above in the body of the action and as necessitated by Applicant’s amendments requiring the region channel.
Claim 18
Applicant’s arguments are on the grounds that Hu allegedly does not provide a structure for heat sealing as in Kim, and neither Hu nor Kim discusses sealing of an inlet.
Applicant’s arguments are not persuasive because Kim discusses sealing of an inlet channel ([0009]: “The sealing device may include: a support unit on which the microfluidic chip is arranged; and a heat-sealing unit for sealing an inlet unit and an outlet unit of the microfluidic chip by applying heat to the inlet unit and the outlet unit.”). Further, the device of Kim provides protrusions over the inlet/outlet to be melted by the heat sealer wherein one skilled in the art would find it obvious to provide such protrusions to the device of Hu when providing the modification of Kim so as to enable the desired heat sealing and achieve the reduced leaking effects. Kim is not relied upon for providing the microfluidic lightbulb or cure any other deficiency in Hu.
Thus, Examiner maintains the rejection of Claim 18 under 35 USC 103.
Claims 19-22 and 24
Regarding Claim 19, Applicant’s arguments are on the grounds that Jovanovich allegedly does not teach a microfluidic architecture for high-plex nucleic acid amplification for more than 40 targets within a sealed cartridge assembly.
Applicant’s arguments are not persuasive because Jovanovich is not relied upon for providing the specific microfluidic architecture of Claim 14 incorporated into Claim 19, but rather Jovanovich is relied on for providing the remote computer system and analyzer for reading the cartridge. The references of Hu and Battrell are provided as showing the cartridge of Claim 14, as discussed above in the body of the action. Further Limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). When an apparatus is claimed, its patentability is based on the structure of the apparatus and not on the function it performs or the field in which it is applied. In this case, whether the device is used for thermal amplification or some other process is immaterial. Thus, Examiner maintains the rejection of Claim 19 under 35 USC 103.
Regarding Claims 22 and 24, Applicant alleges that the elongated teardrop shaped extraction chamber of Claim 22 and the U-shaped RT-PCR chamber of Claim 24 represent more than an obvious matter of design choice because one skilled in the art would have recognized the geometry of a microfluidic device as critical.
Applicant’s arguments are not persuasive because arguments presented by Applicant cannot take the place of evidence in the record – see MPEP 2145(I). "An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness." – see In re Geisler (1997). Applicant has not provided any force of evidence or reasoning to support the elongated teardrop shaped extraction chamber of Claim 22 and the U-shaped RT-PCR chamber of Claim 24 as being critical shapes for the function of the device. Thus, Examiner maintains the rejection of Claims 22 and 24 under 35 USC 103.
Claim 23
Applicant’s arguments are on the grounds that Coursey allegedly does not provide a membrane for capturing nucleic acids, and that the mesh-covered ports of Coursey are materially different from the sealed debubbling arrangement of an RT-PCR chamber.
Applicant’s arguments are not persuasive because the membrane of COursey being configured to retain liquid is thereby configured to capture nucleic acid, not allowing it to flow through. Further, the mesh-covered ports of Coursey commensurately satisfy Applicant’s recited “debubbler” by allowing gas to escape to prevent bubble formation. If applicant wishes a specific architecture for the debubbler, Applicant must recite said architecture in the claims, not merely assert it is common in RT-PCR chambers.
Thus, Examiner maintains the rejection of Claim 23 under 35 USC 103.
Claim 25
Applicant’s arguments are on the grounds that Jones is allegedly non-analogous art for teaching a cell-analyzer apparatus for counting cells, not a microfluidic nucleic-acid amplification system.
Applicant’s arguments are not persuasive because Jones is drawn to a microfluidic device commensurately comprising channels and chambers in a laminated system. When an apparatus is claimed, its patentability is based on the structure of the apparatus and not on the function it performs or the field in which it is applied – see MPEP 2111.02(II). As Applicant acknowledges, MPEP 2141.01(a) states the reference is analagous if “the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem)”. The device of Jovanovich, Jones, and the present invention are of the same field of endeavor, being drawn to respective microfluidic devices of commensurate structure, and solve the same problem of liquid analysis. Thus, Examiner maintains the rejection of Claim 25 under 35 USC 103.
Claim 26
Applicant’s arguments are on the grounds that as Arlett teaches pneumatic fluid actuation as opposed to that of a vertically moving plug, that Arlett allegedly does not teach the device of Claim 26.
Applicant’s arguments are not persuasive because the valve mechanism of Arlett being the “plug” ([0019]: “a first actuator mechanism for actuating the first valve membrane portion and a second actuator mechanism for actuating the second valve membrane portion”), wherein this arrangement allows for more precise control over fluid flow within the device, thereby reducing error due to improper flow patterns. While fluid movement in Arlett is caused by pneumatic action, it is “realized” by the vertical actuation of the plug controlling such fluid movement, thereby satisfying the claim requirements. Thus, Examiner maintains the rejection of Claim 26 under 35 USC 103.
Conclusion
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/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798