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 .
This application 17/580,364 was filed on 01/20/2022.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-10) and Species “a” (one set of oligonucleotide primers comprising SEQ ID NO. 1-4 and 13, which target the gene RdRp), in the reply filed on January 20, 2022, is acknowledged. The traversal is on the ground(s) that “It is believed that multiple groups can be searched and examined together without undue burden. Additionally, considerable time and expense will be saved if all claims can be considered at this time, rather than pursuing multiple divisional applications.” This is not found persuasive because:
Inventions I and II are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h).
In the instant case, Invention I could be used with a different method that does not employ reverse transcription loop-mediated isothermal amplification (RT-LAMP), but instead employs polymerase chain reaction amplification.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
a) the inventions have acquired a separate status in the art in view of their different classification
b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter
c) the inventions require a different field of search (e.g., searching different classes /subclasses or electronic resources, or employing different search strategies or search queries including different structure/sequence searches).
Regarding the patentably distinct species of claims 1, 2 and 4, the species are independent or distinct because the oligonucleotides have different structures. Further, these species hybridize to different genes and amplify different genes. In addition, these species are not obvious variants of each other based on the current record. For instance, the teachings in the specification indicate that different LAMP compositions require different LAMP primer sets (including F3, B3, FIP, and BIP) for each of the RdRp gene, the E gene, and the N gene (pg. 13 and Table 1). The specification further teaches that RNA extraction requires specific probes for each gene (pg. 14 and Table 2).
There is a serious search and/or examination burden for these patentably distinct species as set forth above because at least the following reason(s) apply: Each oligonucleotide requires a different sequence similarity search query in nucleic acid sequence databases, in addition to different keyword and concept search queries of prior art. Further, prior art teaching one sequence is not likely to teach another sequence.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-20 are pending.
Claims 11-20 are withdrawn from consideration as being directed to a non-elected invention.
Claims 1-10 are currently under examination. Claims 1, 2, and 4 have been examined only to the extent that they read on the elected species: one set of oligonucleotide primers comprising SEQ ID NO. 1-4 and 13, which target the gene RdRp. The additional SEQ ID Nos. recited therein are withdrawn from consideration as being drawn to non-elected species. Prior to the allowance of claims, any non-elected subject matter which has not been rejoined with the elected subject matter will be required to be removed from the claims.
Claim Objections
Claim 4 is objected to because of the following informalities: claim 4 refers to the chamber as a “functional chamber” in line 2 but refers to the chamber as a “function chamber” in line 3. Appropriate correction is required.
Improper Markush Group
Claims 1-10 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claims 1, 2 and 4 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
Here, the recited alternative species of SEQ ID Nos. is considered to amplify one of each of the genes recited in Table 1 (claims, 1 and 2) and Table 2 (claim 4).
The recited alternative species in the groups set forth here do not share a single structural similarity, as each different gene that could be detected is itself located in a separate region of the genome and has its own structure. The SEQ ID Nos. recited in the instant claims, do not share a single structural similarity since each consists of a different nucleotide sequence that amplify different genes. The only structural similarity present is that all detected positions are part of nucleic acid molecules. The fact that the SEQ ID Nos. comprise nucleotides per se does not support a conclusion that they have a common single structural similarity because the structure of comprising a nucleotide alone is not essential to the common activity of targeting each of the recited SARS-CoV-2 genes. Accordingly, while the different SEQ ID Nos are asserted to have the property of detecting a specific SARS-CoV-2 gene, they do not share a single structural similarity.
MPEP 2117 (II)(A) provides the following guidance as to what constitutes a physical, chemical, or art recognized class:
“Members of a Markush group share a "single structural similarity" when they belong to the same recognized physical or chemical class or to the same art-recognized class. A recognized physical class, a recognized chemical class, or an art-recognized class is a class wherein there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved. For example, in the context of a claim covering a disposable diaper, a limitation "the fastener selected from the group consisting of a pressure sensitive adhesive and complementary release material, a complementary hook and loop structure, a snap, and a buckle" would likely be considered an art recognized class because a review of the prior art would establish that it was well known that each member could be substituted for each other with the expectation that the intended result (repositionable and refastenable) would occur.”
The recited SEQ ID Nos. do not belong to a recognized chemical class because there is no expectation from the knowledge in the art that these SEQ ID Nos will behave in the same manner and can be substituted for one another with the same intended result achieved. In other words, there is no expectation from the knowledge in the art that each of the recited set of SEQ ID Nos. in claims 1, 2 or claim 4 would function in the same way in the claimed method. Further there is no evidence of record to establish that the recited nucleotide sequences could be used interchangeably to target each of the genes in Table 1 (claims 1 and 2) and Table 2 (claim 4) to detect SAR-Cov-2.
MPEP 2117 (II) further states the following:
“Where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the compounds do not appear to be members of a recognized physical or chemical class or members of an art-recognized class, the members are considered to share a "single structural similarity" and common use when the alternatively usable compounds share a substantial structural feature that is essential to a common use. Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).”
The recited alternative species do not share a substantial common structure merely because they all have a sugar phosphate backbone. The sugar phosphate backbone of a nucleic acid chain is not considered to be a substantial common structural feature to the group of SEQ ID Nos. being claimed because it is shared by ALL nucleic acids. Further, the fact that the SEQ ID Nos. all have a sugar phosphate backbone does not support a conclusion that they have a common single structural similarity because the structure of comprising a sugar phosphate backbone alone is not essential to the asserted common use of targeting a SARS-Cov-2 gene.
Claims 3, and 5-10 depend from claim 1.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
Claim 2 recites the limitation "and wherein the temperature during the reaction of
LAMP is in a range of from 60°C to 65°C. " in line 4-5. There is insufficient antecedent basis for this limitation in the claim because claim 1 does not require “the reaction of LAMP”.
Claim 7 is 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.
With regard to claim 7, the phrase “set on both sides of the micropump and the microvalve” renders the claim as indefinite because the metes and bounds of “set on both sides” are not defined, such as whether it is set above and below or on in the same plane.
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.
Claim(s) 1- 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Broughton et al. (WO 2020/257356 A2) in view of Yuan et al. (CN111893213A, 2020; with English translation) and Chen et al. 2020 (CN111778359A, 2020).
Broughton et al. teaches “a microfluidic cartridge for detecting a target nucleic acid comprising: an amplification chamber fluidically connected to a valve; a detection chamber fluidically connected to the valve, wherein the valve is connected to a sample
metering channel; a detection reagent chamber fluidically connected to the detection chamber via a resistance channel---” (see Broughton pg. 41, [0273]). In Broughton et al., the cartridge is also referred to as a “chip”. Broughton further teaches the device was for SARS-CoV-2 detection (pg.7, [0030]).
Regarding claim 1, Broughton et al. teaches the microfluidic chip comprises a plurality of functional chambers (pg. 1, [0003] and Fig 5, e.g.), a flow control module for transporting the sample (pg. 1, [0003]) and a temperature control module (pg. 4, [0019], continued on pg.5) for controlling temperature (pg. 172, [0476]). The reference refers to a flow control module as a sample metering channel and refers to controlling temperature as thermoregulation. Broughton et al. teaches the chambers were used for loading a sample or reagent (pg. 359, [0891]) and the chambers comprised a LAMP composition (pg. 5, [0022], last sentence). The reference refers to a LAMP composition as LAMP reagents. Broughton further teaches the microfluidic chip comprises a flow control module for transporting the sample, the reagent, the buffer, or the mixture thereof between the chambers, and a temperature control module for controlling and/or keeping a temperature during a reaction (pg. 194, [0524] continued from pg. 193).
Regarding claim 2, Broughton et al. teaches wherein the temperature during the reaction of LAMP was in a range of 60ºC to 65ºC (pg. 271, [0664]).
Regarding claim 3, Broughton et al. teaches wherein the chambers further comprise at least one second functional chamber for loading the sample and/or conducting viral lysis (Pg. 2, [0006]).
Regarding claim 4, Broughton et al. teaches a chamber for RNA extraction (Fig. 46) that contains an RNA capture reagent that is a magnetic bead coated with an RNA probe (pg. 129, [0380]). Broughton et al. refers to the probe as a reporter. Broughton et al. further teaches an RNA probe for detection of SARS-CoV-2 in LAMP (Fig. 87A).
Regarding claim 5, Broughton et al. teaches wherein the temperature control
module comprises: a thermoelectric cooler, a relay configured to turn on the thermoelectric cooler for heating or to turn off the thermoelectric cooler for cooling, and a thermocouple (Fig.135 and Fig. 135 description, [0518]). In Broughton et al., a thermoelectric cooler is referred to as a “heater”, a relay is referred to as a “power control”, and a thermocouple is referred to as “a temperature feedback or a PID loop” [0518].
Regarding claim 6, Broughton et al., teaches wherein the microfluidic chip
further comprises: a fourth functional chamber having a micropump for mixing ([0465] continued from pg.167), and a microvalve arranged between any two adjacent ones of the chambers ([0474] and pg.168, [0465], continued from pg.167).
Regarding claim 9, Broughton et al., teaches wherein the LAMP composition further comprises a fluorescent dye (pg. 300, [0745]), and the integrated microfluidic device further comprises an optical detection module for exciting the fluorescent dye to generate a fluorescent signal and detecting the fluorescence signal (pg. 300 [0745] and pg. 359 [0890]).
Broughton et al. does not teach (i) wherein the LAMP composition in each of the
first functional chambers comprise primers of: SEQ ID Nos. 1 to 4 as recited in claim 1 and claim 2. Broughton further does not teach (ii) an RNA probe of SEQ ID NO. 13 as recited in claim 4.
However, Yuan et al. (CN111893213A, 2020) teaches “---specific screening and identification primers, identification methods and identification kits for screening and identifying novel coronaviruses.” (pg. 1, [0002]).
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Regarding claims 1 and 2, Yuan et al. teaches (i) LAMP primers that comprise SEQ ID No.1 (see Example 1, Page 9, and Table 2, nCoV-ORF1ab-F34). Yuan refers to the RdRp gene as the ORF1ab gene (pg. 3, [0011]). Therefore, the primer taught by Yuan et al. can amplify the same target region of the RdRp gene as SEQ ID No. 1 of the claimed invention. The alignment of SEQ ID No.1 and the corresponding primer taught by Yuan is shown above.
Yuan further teaches “It can be seen that how to obtain a SARS-CoV-2 nucleic acid detection method with simple equipment, easy operation, high sensitivity and specificity is an urgent problem that needs to be solved in the fight against the new coronavirus epidemic. In order to solve the problems in the prior art, the inventors conducted repeated experiments and explorations, compared the published full-length sequences of SARS-Co V2, SARS-Co V, MERS-CoV and other SARS-like viruses, selected the S gene and ORF1ab gene sequence specific regions of the SARS-Co V2
virus as detection targets, designed a set of LAMP primers with high sensitivity and good specificity, and explored the LAMP amplification system and procedure that can simultaneously detect the S gene and ORF1ab gene specific regions, and established a kit and method that can quickly, simply, highly sensitive and highly specific detect SA RS-Co V2.” (pg. 3, [0009]-[0011].
One of ordinary skill in the art, upon reading Yuan, would have recognized the desirability of trying the RdRp gene primers comprising SEQ ID No.1 in the LAMP composition taught by Broughton to provide primers that have high sensitivity and specificity ([0009]).
It would have been prima facie obvious, before the effective filing date of the claimed invention to have modified the LAMP composition taught by Broughton so as to include the RdRp primer comprising SEQ ID No.1 taught by Yuan because Yuan teaches that the primer was designed to target ORF1ab gene sequence- specific regions of the SARS-CoV2 virus in LAMP with high sensitivity and good specificity (pg. 3 [0011]).
Thus, it would have been obvious to one of ordinary skill in the art to try the RdRp gene primers taught by Yuan et al. comprising SEQ ID No.1 in the LAMP composition taught by Broughton to provide excellent performance in clinical detection, with a clinical sample detection compliance rate of 100 % (pg. 7 [0043]).
The combined teachings of Broughton et al. in view of Yuan et al. does not teach (i) wherein the first functional chambers contain primers of SEQ ID Nos. 2 to 4 as recited in claims 1 and 2. Broughton et al. in view of Yuan et al. further does not teach (ii) an RNA probe of SEQ ID NO. 13, as recited in claim 4.
However, Chen et al. 2020 teaches “--- an integrated microfluidic LAMP system for rapidly detecting a target nucleic acid fragment. One subject of the invention is to provide a kit for rapidly detecting a target nucleic acid fragment, the target nucleic acid fragment comprising a purification recognized fragment and an amplification specific fragment, which kit comprises: a magnetic bead linked to an oligonucleotide being able to hybridize to the purification recognized fragment; an inner primer pair and an outer primer pair being specific to the amplification specific fragment and suitable for loop-mediated isothermal amplification; and reagents for loop-mediated isothermal amplification.” (see Summary of the Invention, [0009] – [0013]).
Regarding claim 1 and claim 2, Chen et al. 2020 teaches (i) RT-LAMP primers for the RdRp gene (pg.19 [0114]) that comprise SEQ ID No. 2 and SEQ ID No.4. Chen et al. 2020 further teaches a primer that is functionally equivalent to SEQ ID No. 3. It is therefore inherent that this primer will amplify the same target region of the RdRp gene as SEQ ID No. 3 (pg.19 [0114]). These primers are shown in rows 2 – 4 of Table 5 of the original document (pg. 13, continued on page 14, [0110]).
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A copy of this table is shown below:
The alignments of SEQ ID Nos. 2, 3 and 4 of the instant invention to the corresponding primers taught by Chen et al 2020 are shown below:
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Chen et al. 2020 further teaches “The sequences of the fragments used for detection on the RdRp gene and N gene need to be different from the gene sequences of other pathogens (cannot form complementary binding), and the fragments used for
detection on these two genes need to be suitable for LAMP amplification. Not all unique fragments on the RdRp gene and the N gene can be used for LAMP amplification.
Among them, the unique fragments on the RdRp gene and the N gene refer to the fragments that do not or are not easily complementary to the genes of other pathogens, also known as specific fragments. During the research process of the present inventors, some specific fragments were found on the RdRp gene, and some specific fragments were also found on the N gene. The inventors designed LAMP primers for the above-mentioned specific fragments and verified the amplification effect through a large number of experiments. The results showed that: only a specific fragment on the RdRp gene can be successfully amplified by LAMP (we call this fragment the RdRp gene detection target fragment), and the first primer combination of this scheme is designed to achieve the detection of the RdRp gene.” (pg. 5, 172-185).
One of ordinary skill in the art, upon reading Chen et al. 2020, would have recognized the desirability of utilizing the RdRp gene primers comprising SEQ ID Nos. 2-4 in the LAMP composition taught by Broughton et al. in view of Yuan et al. to provide primers that are different from the gene sequences of other pathogens and also suitable for LAMP amplification.
It would have been prima facie obvious, before the effective filing date of the claimed invention to have modified the LAMP composition taught by Broughton et al. in view of Yuan et al. so as to include the RdRp primers taught by Chen et al. 2020 comprising SEQ ID Nos. 2-4 because Chen et al. 2020 teaches that the primers amplify a unique fragment of the RdRp gene and are also suitable for LAMP (pg. 5, 176-179).
Thus, it would have been obvious to one of ordinary skill in the art to try the RdRp gene primers taught by Chen et al. 2020 comprising SEQ ID Nos. 2-4 in the LAMP composition taught by Broughton et al. in view of Yuan et al. to provide a LAMP composition that can successfully amplify the RdRp gene fragment (pg. 5, 182-184).
Regarding claim 4 Chen et al. 2020 further teaches (ii) primers that hybridize to the RdRp gene corresponding to the region amplified by an RNA probe of SEQ ID NO. 13. Chen et al. 2020 does not specifically teach a probe of SEQ ID NO. 13. However, SEQ ID NO. 13 is within the target region that would be amplified by the LAMP primers that the reference teaches. The figure below shows primer location of the RdRp gene that Chen et al. 2020 teaches. The red box indicates the region that will hybridize SEQ ID No.13:
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The alignment of SEQ ID No. 13 to the primer location of the RdRp gene region taught by Chen et al. 2020 is below:
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One of ordinary skill in the art, upon reading Chen et al. 2020, would have recognized the desirability of following the example of an RNA capture reagent that is a magnetic bead coated with an RNA probe taught by Broughton et al. in view of Yuan et al. with the primer location of the RdRp gene taught by Chen to detect the target region of the RdRp gene containing SEQ ID No. 13.
It would have been prima facie obvious, before the effective filing date of the claimed invention to have modified the chamber for RNA extraction taught by Broughton et al. in view of Yuan et al. so as to contain a capture probe from the primer location of the RdRp gene taught by Chen et al. 2020 because Chen et al. 2020 teaches that the primers amplify a unique fragment of the RdRp gene and are also suitable for LAMP (pg. 5, 176-179).
Thus, it would have been obvious to one of ordinary skill in the art to try a capture probe from the primer location of the RdRp gene taught by Chen et al. 2020 to provide a probe that will aid in isolation of the target sequence of SEQ ID No. 13.
Claim(s) 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Broughton et al. (WO2020257356A2) in view of Yuan et al. (CN111893213A, 2020) and Chen et al. 2020 (CN111778359A, 2020) and further in view of Tanner et al. (US10968493B, 2020) and Chen et al. 2012 (US 2012/0141989A1).
The combined teachings of Broughton et al. in view of Yuan et al. and Chen et al. 2020 as they relate to the elements of claims 7 and 8 that require an integrated microfluidic device as recited in claim 1 are given above in the 103 rejection for claim 1.
Regarding claim 7, Broughton et al. in view of Yuan et al. and Chen et al. 2020 does not teach wherein the flow control module is a magnetic control module comprising a permanent magnet and an electromagnet respectively set on both sides of the micropump and the microvalve.
However, Chen et al. 2012 teaches “--- an integrated microfluidic LAMP system for rapidly detecting a target nucleic acid fragment.” (pg. 2 [0009]). Chen et al. 2012 further teaches “A microfluidic control module comprising two sets of pneumatic micro-pumps with three PDMS membranes and a floating block structure is used to precisely transport biosamples and to prevent backflow. The time-phased deformation of successive PDMS membranes underneath the microchannel generates a peristaltic effect that drives the liquid along the microchannel when the compressed air fills up the
interconnected air chambers sequentially. Two essential parameters including the driving frequency (fd) of the electromagnetic valve (EMV) and the applied compressed air pressure can be used to control the flow pumping rate for sample transport.” (pg. 6 [0073]). Chen et al. 2012 further teaches “The microfluidic chip also known as a lab-on-a chip, and the use of microfluidic chip for biomedical detection or analysis has advantages of reduced manual error, increased system stability, reduced energy consumption and reduced amount of samples, reduced the capacity and time-saving.” (pg.3 [0043]).
Regarding claim 7, Chen et al. 2012 teaches the flow control module is a magnetic control module comprising a permanent magnet and an electromagnet respectively set on both sides of the micropump and the microvalve (pg. 4 [0045]). Chen et al. 2012 refers to a flow control module as a microfluidic control module and the electromagnet as a magnetic stage.
Chen et al. 2012 further teaches “Despite the attractiveness of the LAMP technique, there are still some potential draw backs in developing rapid diagnostic devices utilizing these state-of-the-art laboratory techniques.” --- More importantly, bio-sample pre-treatment processes prior to analysis such as DNA/RNA extraction are always required and need to be performed by experienced personnel. Therefore, there is a great need to develop an integrated sample-to-answer system to carry out all the diagnostic processes with a high specificity and sensitivity, in an automatic manner.” (pg. 1 [0008], cont’d on pg.2).
One of ordinary skill in the art, upon reading Chen et al. 2012 , would have recognized the desirability of trying a magnetic control module comprising a permanent magnet and an electromagnet respectively set on both sides of the micropump and the microvalve to control the flow pumping rate for sample transport.
It would be obvious before the effective filing date of the instant application to have modified the method taught by Broughton et al. in view of Yuan et al. and Chen et al. 2020 to have used the magnetic control module comprising a permanent magnet and an electromagnet respectively set on both sides of the micropump and the microvalve because taught by Chen et al. 2012 because Chen et al. 2012 teaches the driving frequency (fd) of the electromagnetic valve (EMV) is essential to control the flow pumping rate for sample transport (pg. 6 [0073]).
Thus, it would have been obvious to one of ordinary skill in the art to try the magnetic control module comprising a permanent magnet and an electromagnet respectively set on both sides of the micropump and the microvalve to further develop an integrated sample-to-answer system to carry out all the diagnostic processes with a high specificity and sensitivity, in an automatic manner (pg.1 [0008], cont’d on pg.2).
Regarding claim 8, Broughton et al. teaches the flow control module is a pneumatic combined electromagnetic control module (pg. 171 [0474]) comprising a vacuum pump (pg. 44 [0298] and Fig. 127A). In Broughton et al. a vacuum pump is referred to as a pump. Broughton et al. further teaches the flow control comprises a compressor (pg. 358 [0887] and Fig. 127A). Broughton et al. refers to a compressor as “--- a pneumatic pumping manifold that can apply pressure to individual cartridge chambers”. (pg. 358 [0887] and Fig. 163).
Broughton et al. further teaches wherein the microfluidic chip further comprises an air hole for air flow controlled by the pneumatic combined electromagnetic control module. (pg. 358 [0887] and Fig. 163). In Broughton et al., and air hole is referred to as a port.
Broughton et al. in view of Yuan et al. and Chen et al. 2020 do not teach wherein
the flow control module comprises an electromagnetic valve.
However, Chen et al. 2012 teaches the flow control module comprises an electromagnetic valve (pg. 6 [0073]).
One of ordinary skill in the art, upon reading Chen et al. 2012 , would have recognized the desirability of trying wherein the flow control module comprises an electromagnetic valve to control the flow pumping rate for sample transport.
It would have been prima facie obvious, before the effective filing date of the instant application, to have modified the method taught by Broughton et al. in view of Yuan et al. and Chen et al. 2020 to have used an electromagnetic valve because Chen et al. 2012 teaches “Two essential parameters including the driving frequency (fd) of the electromagnetic valve (EMV) and the applied compressed air pressure can be used to control the flow pumping rate for sample transport.” (pg. 6 [0073]).
Thus, it would have been obvious to one skilled in the art to have the flow control module comprise an electromagnetic valve other to achieve reduced manual error, increased system stability, reduced energy consumption and reduced number of samples, reduced the capacity and time-saving. (pg.3 [0043]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Broughton et al. (WO2020257356A2) in view of Yuan et al. (CN111893213A, 2020) and Chen et al. 2020 (CN111778359A, 2020) and further in view of Tan et al. (WO 2008/124104 A1).
The combined teachings of Broughton et al. in view of Yuan et al. and Chen et al. 2020 as they relate to the elements of claim 10 that require an integrated microfluidic device as recited in claim 9 are given above in the 103 rejection for claim 9.
Regarding claim 10, Broughton et al. teaches wherein the optical detection module comprises a light source ([0896] and FIG. 168). Broughton et al. refers to the light source as light-emitting diodes.
Broughton et al. in view of Yuan et al. and Chen et al. 2020 does not teach wherein the optical detection module comprises an objective lens, and a photomultiplier tube.
However, Tan et al. teaches “The present disclosure provides fully integrated microfluidic systems to perform nucleic acid analysis.” --- “The present disclosure also provides optical detection systems and methods for separation and detection of biological molecules. In particular, the various aspects of the invention enable the simultaneous separation and detection of a plurality of biological molecules, typically fluorescent dye-labeled nucleic acids, within one or a plurality of microfluidic chambers or channels.” (Abstract). Tan et al. further teaches “There is an unmet need for the development of instruments and technologies that would permit fully integrated (i.e., sample-in to results-out) focused nucleic acid analysis, defined as the rapid identification (by nucleic acid sequencing or fragment sizing) of a subset of a given human, animal, plant, or pathogen genome.” (pg. 1, lines 17-21).
Regarding claim 10, Tan et al. teaches wherein the optical detection module comprises an objective lens and a photomultiplier tube. Tan et al. refers to an objective lens as a lens and the photomultiplier tube as both a photomultiplier tube (PMT) detector.
Tan et al. further teaches “The instrument comprises excitation and detection subsystems for interacting with and interrogating a sample.” (pg. 34, lines 5-10), and “The detection subsystem comprises one or more optical detectors, a wavelength dispersion device (which performs wavelength separation), and one or a series of optical elements including, but not limited to, lenses, pinholes, mirrors and objectives to collect emitted fluorescence from fluorophore-labeled DNA fragments that are present at the excitation/detection window.” Tan et al. further teaches “More than eight dyes can be detected by applying additional dichroic mirrors, bandpass filters and PMT.” (pg. 35 lines 8-10 and 14-17).
One of ordinary skill in the art, upon reading Tan et al., would have recognized the desirability of using an optical detection module comprising an objective lens and a photomultiplier tube to interact with and interrogate a sample.
It would have been prima facie obvious, before the effective filing date of the instant application, to have modified the method taught by Broughton et al. in view of Yuan et al. and Chen et al. 2020 to have used the optical detection module comprising an objective lens and a photomultiplier tube taught by Tan et al. because Tan et al. teaches that “There is an unmet need for the development of instruments and technologies that would permit fully integrated (i.e., sample-in to results-out) focused nucleic acid analysis, defined as the rapid identification (by nucleic acid sequencing or fragment sizing) of a subset of a given human, animal, plant, or pathogen genome.” (pg. 1, lines 17-21).
Thus, it would have been obvious to one skilled in the art to try the optical detection module comprises an objective lens and a photomultiplier tube taught by Tan et al in the optical detection module of Broughton et al. in view of Yuan et al. and Chen et al. 2020 in order to further develop instruments and technologies that would permit fully integrated (i.e., sample-in to results-out) focused nucleic acid analysis, of a subset of a pathogen genome.” (pg. 1, lines 17-21).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA POMPILIUS whose telephone number is (571)270-5581. The examiner can normally be reached Mon - Fri 9:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Winston Shen, can be reached at (571) 272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MELISSA S. POMPILIUS/ Examiner, Art Unit 1682
/WU CHENG W SHEN/ Supervisory Patent Examiner, Art Unit 1682