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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 133, 202, 205, and 206. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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 objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following must be shown or the feature(s) canceled from the claim(s):
(1) “a plurality of openings through the cartridge body in fluid communication with the diluted sample cavity and metering channel, wherein the plurality of openings are configured to be shut by a valve on a reader device” of claim 1;
(2) “an external push rod on the reader device” of claim 1; and
(3) “a plurality of openings in the cartridge each align with individual valves in the reader configured to open or close the openings in the cartridge” of claim 12.
No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
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.
No claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1 and 11-12 are objected to because of the following informalities:
in claim 1, line 11: “fist” should be “first”;
in claim 1, line 16: “fist” should be “first”; and
in claim 11, line 1: the semicolon after “more of” should be a colon;
in claim 11, line 1: THC should be “tetrahydrocannabinol (THC)”;
in claim 12, line 6: “respective” should be inserted before “openings”; and
in claim 12, line 12: a comma should be inserted after “a metering well”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 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.
Claims 1-11 are generally indefinite since it is not clear if the following terms are supposed to be the same as, different from, or related to each other:
“a subject's saliva” of claim 1, line 1;
“a diluted saliva sample” of claim 1, line 7;
“fluid” of claim 1, line 20;
“fluid” of claim 1, line 22;
“control fluid” of claim 4, line 3 (a type of fluid);
“a buffer solution” of claim 5, line 1 (a type of fluid);
“a saliva sample” of claim 6, line 2;
“saliva” of claim 7, line 3;
“saliva” of claim 7, line 5;
“a dilution buffer” of claim 8, line 3 (a type of fluid);
“a preservation solution” of claim 8, line 5 (a type of fluid);
“any saliva” of claim 9, line 4; and
“the mixed and diluted saliva” of claim 9, line 5.
All of the above are a type of fluid and/or saliva yet the claims do not attempt to relate or distinguish these terms to each other. Such overlapping terms creates confusion as to when certain terms are referring to the same fluid or different fluids. This confusion renders claims 1-11 indefinite.
Claim 1 recites “a plurality of openings through the cartridge body in fluid communication with the diluted sample cavity and metering channel” in lines 12-13, but it is not clear if each of the plurality of openings are in fluid communication with both the diluted sample cavity and metering channel or a portion of the openings are in fluid communication with the diluted sample cavity and another portion of the openings are in fluid communication with metering channel. Clarification is required.
Claim 1 recites “a reader device” in line 14, but it is not clear if this recitation is the same as, related to, or different from “a reader device” of claim 1, line 1. If they are the same, “a reader device” in line 14 should be “the reader device”. If they are different, the relationship between these two recitations should be made clear; they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent mention of “the reader device” should make it clear which recitation is being referred to.
Claim 1 recites “an external push rod on the reader device” in line 19, but it is not clear if the reader device is part of the claimed invention. The recitation “A cartridge for testing a subject's saliva for a drug using a reader device” of claim 1, line 1 suggests that the reader device is not part of the claimed invention. However, the recitation of a particular structure of the reader device in line 19 suggests that the reader device is part of the claimed invention. This confusion renders claim 1 indefinite.
Claim 1 recites “wherein displacement of the diaphragm by an external push rod on the reader device to the second distance pushes fluid through the serpentine mixing channel in a first direction and further wherein releasing the diaphragm to the neutral position pulls fluid through the serpentine mixing channel in a second direction” in lines 19-22, which is an action step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)).
Claims 1-11 are rejected by virtue of their dependence from claim 1.
Claim 7 recites “wherein the saliva collection body comprises a first swab piston extending distally from the collection body” in lines 1-2, but it is not clear how the first swab piston can extend distally from the collection body (which conveys that the first swab piston is different from the collection body) when the first swab piston is part of the collection body. This contradiction renders claim 7 indefinite.
Claim 7 recites “wherein the saliva collection body comprises…a second swab piston extending distally from the collection body” in lines 1-4, but it is not clear how the second swab piston can extend distally from the collection body (which conveys that the second swab piston is different from the collection body) when the second swab piston is part of the collection body. This contradiction renders claim 7 indefinite.
Claim 8 recites “the first swab piston” in line 2, “the second channel piston” in lines 2-3, “the collection body” in lines 4-5, and “the second swab piston” in line 7 in which there are insufficient antecedent bases for these limitations in the claim. Also, it is not clear what relationship the first swab piston, the second channel piston, the collection body, and the second swab piston have with the other structural features of the claim. Further, it is not clear if “the second channel piston” in lines 2-3 and “the second swab piston” in line 6 are supposed to be the same as or different from each other. Clarification is required.
Claim 9 is rejected by virtue of its dependence from claim 8.
Claim 9 recites “the first internal channel” in line 4 in which there is insufficient antecedent basis for this limitation in the claim. Also, it is not clear what relationship this first internal channel has with the other structural features of the claim. Clarification is required.
Claim 12 is generally indefinite since it is not clear if the following terms are supposed to be the same, different, or related to each other:
“a subject's saliva” of claim 12, line 1;
“fluid” of claim 12, line 11;
“fluid” of claim 12, line 18;
“air” of claim 12, line 19 (a type of fluid);
“fluid” of claim 12, line 21; and
“the fluid” of claim 12, line 24.
All of the above are a type of fluid and/or saliva yet the claim does not attempt to relate these terms to each other. Such overlapping terms creates confusion as to when certain terms are referring to the same fluid or different fluids. This confusion renders claim 12 indefinite.
Claim 12 recites “a diaphragm on the cartridge” in line 7, but it is not clear if this recitation is the same as, related to, or different from “a diaphragm on the cartridge” of claim 12, line 4. If they are the same, “a diaphragm on the cartridge” in line 7 should be “the diaphragm on the cartridge”. If they are different, the relationship between these two recitations should be made clear; they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent mention of “the diaphragm” should make it clear which recitation is being referred to.
Claim 12 recites “a first opening” in line 8, “a second opening” in line 10, and “a third opening” in line 15, but it is not clear if one or more of these recitations are the same as, related to, a subset of, or different from “a plurality of openings” of claim 12, line 4. The relationship among these recitations should be made clear.
Claim 12 recites “the mixing well” in lines 22-23 in which there is insufficient antecedent basis for this limitation in the claim. Also, it is not clear what relationship this mixing well has with the other structural features of the claim. Clarification is required.
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.
Claims 1-6 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2008/0118397 (Slowey), in view of U.S. Patent No. 6,942,771 (Kayyem), and further in view of U.S. Patent Application Publication No. 2016/0033412 (Tan), and further in view of U.S. Patent Application Publication No. 2011/0318774 (Larsen), and further in view of U.S. Patent Application Publication No. 2003/0175947 (Liu).
Slowey discloses a saliva collection system comprising: handle components 14a, 14b; test strips 16a, 16b; and the view ports 60 (FIG. 10 of Slowey), wherein the handle components 14a, 14b is configured for insertion into an electro-optical reader (the electronic reading device; paragraphs 0031 and 0092-0099 of Slowey).
Slowey teaches that the handle components 14a, 14b are configured for insertion into a reader (the electronic reading device; paragraphs 0031 and 0092-0099 of Slowey). Kayyem discloses an alternative to test strips using a microfluidic system for analysis of analytes in saliva (col. 6, lines 12-32 of Kayyem) using microchannels, storage module for assay reagents, detection modules, reagent storage wells for elution buffer, reaction modules, valves, waste wells, and pumps (FIGS. 1A-1D of Kayyem; col. 1, line 45 to col. 2, line 40; FIGS. 1A-1D of Kayyem). Tan teaches a cartridge having a housing portion containing an arrangement of a filter for filtering the biological sample, a cavity for metering the sample, a cavity for mixing the sample with reagents, and an optical reader in that order (paragraphs 0063-0064, 0080-0083, and 0088 of Tan). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a microfluidic system, as suggested by Kayyem, in the form of a housing with the filter, the metering cavity, the mixing cavity, and the path to the optical reader in that order, as suggested by Tan, since it is a simple substitution of one known element for another to obtain predictable results and it provides a tangible arrangement suitable for the processing of a target analyte in a biological fluid.
Kayyem teaches that pumps may be used (col. 1-2 of Kayyem). Tan also teaches the application of fluid pressure to push or pull fluid (including the sample fluid) into the compartments and allow mixing with the loaded reagents (paragraphs 0080-0083 and 0088 of Tan). Suction (negative pressure) may be applied at a port, such as an exit port and/or an entrance port, to pull fluid into or out of the chamber (paragraphs 0080-0083 and 0088 of Tan). Larsen teaches that the membrane may be located in the insertable element while the actuating element may be located in the docking element (paragraphs 0038 and 0062 of Larsen). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the membrane in the cartridge and the actuating element in the reader since it is a simple substitution of one known element for another to obtain predictable results and it provides a safeguard that the pumping operation cannot be instituted until the cartridge is in the reader.
Tan discloses that sensing surfaces on a sensing chip and optical waveguides are used to interface with electro-optical readers (paragraphs 0008-0019, 0039, 0044, and 0062-0065 of Tan). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the sensing surfaces on a sensing chip and optical waveguides of Tan in the handle components of Slowey since a method of transmission to the electro-optical components of the reader is required and Tan discloses such a method of transmission and/or it permits the more efficient transmission of the optical data.
Tan also teaches the use of valves and vents for manipulating the sample (paragraphs 0063-0064, 0080-0083, and 0088 of Tan). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the valves and vents of Tan in the combination since it provides a method for manipulating the movement of the samples through the microfluidic system. Larsen teaches that valves may be located in the docking element (paragraphs 0063 and 0154 of Larsen). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the valve in the reader for opening and closing flow to the vents since it provides a safeguard that the flowing operation cannot be instituted until the cartridge is in the reader.
Liu teaches that serpentine channels increase mixing (paragraph 0068 of Liu). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use serpentine channels in the combination as the mixing chamber since it would increase mixing and/or it is simple substitution of one known element for another to obtain predictable results.
With respect to claim 1, the combination teaches or suggests a cartridge for testing a subject's saliva for a drug using a reader device, the cartridge comprising:
a cartridge body (the handle components 14a, 14b of Slowey; the housing of Tan);
a photonic chip comprising a plurality of waveguides having an exposed edge on one end of the cartridge body (the plurality of waveguides of Tan), further comprising the drug bound to a surface of the photonic chip above the plurality of waveguides (the sensing surface on the sensing chip of Tan; drug detection of paragraphs 0061, 0081, 0088, 0096-0097, 0099 of Slowey);
a diluted sample cavity configured to hold a diluted saliva sample (the initial cavity in handle 114 of Slowey ‘397);
a metering channel within the cartridge body in fluid communication with the diluted sample cavity (the metering cavity of Tan);
a serpentine mixing channel in fluid communication with the metering channel at a fist end and in fluid communication with the photonic chip at a second end (the serpentine channel of Liu);
a plurality of openings through the cartridge body in fluid communication with the diluted sample cavity and metering channel (the vents suggested by Tan), wherein the plurality of openings are configured to be shut by a valve on a reader device (the valve of Tan in the reader as suggested by Larsen);
a diaphragm in the cartridge body (the diaphragm suggested by Tan and Larsen), the diaphragm having a neutral position, a first displaced position extending a fist distance from the neutral position and a second displaced position extending a second distance from the neutral position that is greater than the first distance; and
wherein displacement of the diaphragm by an external push rod on the reader device to the second distance pushes fluid through the serpentine mixing channel in a first direction and further wherein releasing the diaphragm to the neutral position pulls fluid through the serpentine mixing channel in a second direction (the action the actuating element in the reader as suggested by Tan and Larsen).
With respect to claim 2, Kayyem teaches that antibodies are used as reagents teaches that antibodies may be used (col. 11, lines 10-40 of Kayyem) and that fluorescent labels are used (col. 80, lines 25-37 of Kayyem). Tan teaches that lyophilized and fluorescently-marked antibodies may be used be used as reagents (paragraphs 0066, 0080, 0083, 0095, and 0100 of Tan). It would have been obvious to use a lyophilized and fluorescently-marked antibody in fluid communication with the metering channel since a form a reagent is required and Kayyem and Tan teach such forms.
With respect to claim 3, Tan teaches the use of a waste reservoir and a passage thereto so as to contain the reagents and sample after being used (0063-0064, 0080-0083, and 0088 of Tan). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the waste reservoir and a passage thereto of Tan in the combination since it provides a location where the reagents and sample can be contained after being used. Thus, the combination teaches or suggest a waste channel fluidly connected to a waste chamber and in fluid communication with the photonic chip.
With respect to claim 4, Tan teaches the use of a plurality of mixing chambers (paragraph 0008 and 0080 of Tan). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use multiple mixing chambers as suggested by Tan since it permits multiple opportunities for mixing. Liu teaches that serpentine channels increase mixing (paragraph 0068 of Liu). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use serpentine channels in the combination as the mixing chambers since it would increase mixing and/or it is simple substitution of one known element for another to obtain predictable results. Tan teaches the use of buffer solutions (paragraph 0074, 0083-0084, 0100 of Tan). Thus, the combination teaches or suggests a second serpentine mixing channel (the second serpentine mixing channel of the combination) in fluid communication with the photonic chip in fluid connection with a second metering channel coupled to a source of control fluid (the buffer solution of Slowey).
With respect to claim 5, Tan teaches the use of chambers with a buffer solution (paragraphs 0074, 0084, 0100 of Tan); Liu teaches the use of buffer solutions (paragraph 0165 of Liu); and Kayyem teach the use of buffer solutions (col. 1, lines 45-65; col. 9, lines 60-65; col. 12, lines 34-37 of Kayyem). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a chamber with a buffer solution so as to tailor the sample to a specific test’s requirements. Thus, the combination teaches a blister pack containing a buffer solution.
With respect to claim 6, the combination teaches or suggests a saliva collection body extending distally from the cartridge body, and configured to collect and dilute a saliva sample from the subject (the split absorbent pad 115 of Slowey).
With respect to claim 10, the combination teaches or suggests that the drug comprises one or more drugs of addiction (paragraphs 0096-0097 of Slowey).
With respect to claim 11, the combination teaches or suggests that the drug comprises one or more of; cocaine (paragraph 0009 of Slowey), THC (paragraphs 0012, 0057, 0061, and 0081 of Slowey), an opiate, and benzodiazepine (paragraphs 0097 of Slowey).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Slowey, in view of Kayyem, and further in view of Tan, and further in view of Larsen, and further in view of Lui, and further in view of U.S. Patent No. 3,792,699 (Tobin).
Slowey ‘397 discloses a split absorbent pad 115. Tobin discloses a dual swab configuration (FIG. 2 of Tobin) that is functionally equivalent to the split absorbent pad of Slowey ‘397. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the dual swab configuration of Tobin in place of the split absorbent pad of Slowey ‘397 since it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 7, the combination teaches or suggests that the saliva collection body comprises a first swab piston extending distally from the collection body, the first swab piston comprising a first internal channel configured to wick saliva from an open distal end of the first swab piston (the first swab of Tobin); and a second swab piston extending distally from the collection body, the second swab piston comprising a second internal channel configured to wick saliva from an open distal end of the second swab piston (the second swab of Tobin).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Slowey, in view of Kayyem, and further in view of Tan, and further in view of Larsen, and further in view of Lui, and further in view of Tobin, and further in view of U.S. Patent No. 5,827,675 (Skiffington) or U.S. Patent Application Publication No. 2006/0216196 (Satoh).
Slowey ‘397 discloses a split absorbent pad 115. Tobin discloses a dual swab configuration (FIG. 2 of Tobin) that is functionally equivalent to the split absorbent pad of Slowey ‘397. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the dual swab configuration of Tobin in place of the split absorbent pad of Slowey ‘397 since it is a simple substitution of one known element for another to obtain predictable results.
Slowey ‘397 further teaches that the compression tube 120 may be provided with caps for sealing (paragraph 0091 of Slowey ‘397). Skiffington or Satoh discloses membrane or frangible seals for containing solutions in tubes (seals 74, 20 of Skiffington; col. 6, lines 30-65 of Skiffington; seals 62 and 77; paragraphs 0044, 0046, and 0053-0054 of Satoh). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a seal for each tube in the compression tube 120 of Slowey ‘397 since (1) Slowey ‘397 teaches that the compression tube 120 may be provided with caps for sealing and Skiffington or Satoh teaches one such cap for sealing, and/or (2) it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 8, the combination teaches or suggests a cap having a first tube (one tube of the compression tube 120 of Slowey ‘397) configured to receive the first swab piston (one of the stems 47 of Tobin) and a second tube (the other tube of the compression tube 120 of Slowey ‘397) configured to receive the second channel piston (the other of the stems 47 of Tobin); a dilution buffer within the first tube (the buffer solution in the one tube of Slowey ‘397; paragraphs 0079 and 0091 of Slowey ‘397) and covered by a first frangible cover that is configured to be pierced by the first swab piston when the cap is attached to the collection body (the seals of the combination); and a preservation solution (the buffer solution in the other tube of Slowey ‘397; paragraphs 0079 and 0091 of Slowey ‘397), having a different composition than the dilution buffer, within the second tube and covered by a second frangible cover that is configured to be pierced by the second swab piston when the cap is attached to the collection body (the seals of the combination).
With respect to claim 9, the combination teaches or suggests a fastener configured to secure the cap to the collection body when a predetermined amount of force is applied (the lock 160 and key 162 of Slowey ‘397), wherein the first swab piston and first tube are configured so that securing the cap to the collection body drives the dilution buffer through the first internal channel to mix and dilute any saliva within the first internal channel and to push the mixed and diluted saliva into the diluted sample cavity.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Slowey, in view of Kayyem, and further in view of Tan, and further in view of Larsen, and further in view of Lui, and further in view of BR 112018074103 (Drews). Citations to Drews will rely upon the accompanying English machine translation.
Slowey discloses a saliva collection system comprising: handle components 14a, 14b; test strips 16a, 16b; and the view ports 60 (FIG. 10 of Slowey), wherein the handle components 14a, 14b is configured for insertion into an electro-optical reader (the electronic reading device; paragraphs 0031 and 0092-0099 of Slowey).
Slowey teaches that the handle components 14a, 14b are configured for insertion into a reader (the electronic reading device; paragraphs 0031 and 0092-0099 of Slowey). Kayyem discloses an alternative to test strips using a microfluidic system for analysis of analytes in saliva (col. 6, lines 12-32 of Kayyem) using microchannels, storage module for assay reagents, detection modules, reagent storage wells for elution buffer, reaction modules, valves, waste wells, and pumps (FIGS. 1A-1D of Kayyem; col. 1, line 45 to col. 2, line 40; FIGS. 1A-1D of Kayyem). Tan teaches a cartridge having a housing portion containing an arrangement of a filter for filtering the biological sample, a cavity for metering the sample, a cavity for mixing the sample with reagents, and an optical reader in that order (paragraphs 0063-0064, 0080-0083, and 0088 of Tan). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a microfluidic system, as suggested by Kayyem, in the form of a housing with the filter, the metering cavity, the mixing cavity, and the path to the optical reader in that order, as suggested by Tan, since it is a simple substitution of one known element for another to obtain predictable results and it provides a tangible arrangement suitable for the processing of a target analyte in a biological fluid.
Kayyem teaches that pumps may be used (col. 1-2 of Kayyem). Tan also teaches the application of fluid pressure to push or pull fluid (including the sample fluid) into the compartments and allow mixing with the loaded reagents (paragraphs 0080-0083 and 0088 of Tan). Suction (negative pressure) may be applied at a port, such as an exit port and/or an entrance port, to pull fluid into or out of the chamber (paragraphs 0080-0083 and 0088 of Tan). Larsen teaches that the membrane may be located in the insertable element while the actuating element may be located in the docking element (paragraphs 0038 and 0062 of Larsen). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the membrane of Tan in the cartridge and the actuating element in the reader since it is a simple substitution of one known element for another to obtain predictable results and it provides a safeguard that the pumping operation cannot be instituted until the cartridge is in the reader.
Tan discloses that sensing surfaces on a sensing chip and optical waveguides are used to interface with electro-optical readers (paragraphs 0008-0019, 0039, 0044, and 0062-0065 of Tan). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the sensing surfaces on a sensing chip and optical waveguides of Tan in the handle components of Slowey since a method of transmission to the electro-optical components of the reader is required and Tan discloses such a method of transmission and/or it permits the more efficient transmission of the optical data.
Tan also teaches the use of valves and vents for manipulating the sample (paragraphs 0063-0064, 0080-0083, and 0088 of Tan).1 It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the valves and vents of Tan in the combination since it provides a method for manipulating the movement of the samples through the microfluidic system. Larsen teaches that valves may be located in the docking element (paragraphs 0063 and 0154 of Larsen). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the valves for opening and closing flow to the vents in the reader since it provides a safeguard that the flowing operation cannot be instituted until the cartridge is in the reader.
Liu teaches that serpentine channels increase mixing (paragraph 0068 of Liu). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use serpentine channels in the combination as the mixing chamber since it would increase mixing and/or it is simple substitution of one known element for another to obtain predictable results.
In view of the above, the combination teaches or suggests the operation of filtering the biological sample using a filter, metering the sample using a cavity, mixing the sample with onboard reagents or the added reagents using a serpentine channel, and channeling the flow to an optical reader. These flow operations are performed with the application of fluid pressure to push or pull fluid (including the sample fluid) into the compartments and allow mixing with the loaded reagents (paragraphs 0080-0083 and 0088 of Tan) using a diaphragm in the cartridge, actuating members in the reader, valves, and vents for manipulating the sample (paragraphs 0063-0064, 0080-0083, and 0088 of Tan).
Drews teaches of oscillating the pump to move the reagents in the mixing volume to mix the reagents (paragraph 0089 on page 18 of Drews). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to oscillate the pump to move the reagents in the mixing volume, as suggested by Drews so as to ensure complete mixing of the reagent.
With respect to claim 12, the combination teaches or suggests a method of testing a subject's saliva for a drug, the method comprising:
inserting a cartridge into a reader so that: an outer edge of a photonic chip in the cartridge is aligned with an optical sensor in the reader (inserting the cartridge into the reader as suggested by Slowey), a piston in the reader (the actuating element in the reader as suggested by Tan and Larsen) aligns with a diaphragm on the cartridge (the diaphragm suggested by Tan and Larsen), and a plurality of openings in the cartridge (the vents suggested by Tan), each align with individual valves in the reader configured to open or close the openings in the cartridge (the valve of Tan in the reader as suggested by Larsen);
pushing, using the piston, on a diaphragm on the cartridge to displace the diaphragm from a neutral position to a first deflected position while a first opening in the cartridge is open (setting the pump for pulling the fluid through the system);
closing the first opening and opening a second opening in the cartridge (finish setting the pump and preparing for pulling fluid to the cartridge);
partially releasing the diaphragm by withdrawing the piston to pull fluid from a diluted sample cavity in the cartridge into a metering well (moving fluid into the metering well) wherein the second opening is in fluid communication with the diluted sample cavity distal to the metering well;
closing the second opening and opening a third opening that is in fluid communication with a region between the metering well and the diluted sample cavity (preparing for moving the fluid into the mixing chamber);
releasing the diaphragm further by further withdrawing the piston to pull fluid into the metering well and to introduce air between the metering well and the diluted sample cavity (moving the fluid into the mixing chamber);
alternatively pushing and releasing the piston to push and pull fluid from the metering well within a serpentine mixing channel in fluid communication with the mixing well (the oscillation suggested by Drews);
releasing the piston to pull the fluid from the serpentine mixing channel onto a surface of the photonic chip (moving the fluid to the chip); and
reading an evanescent optical signal from a waveguide of the photonic chip (making measurements using the chip).
Conclusion
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
1 Col. 14-15 of U.S. Patent No. 5,104,813 also teaches how vents and valves are used to manipulate fluid flow in cartridges.