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 .
Specification
The Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the implied phrasing “[0001] The present disclosure relates to…” in line 1 is improper. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
an imaging system in claim 1;
one or more external computing devices in claim 13;
an imaging system in claim 19; and
an imaging system in claim 20.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-20 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.
Claim 1 recites “the presence of one or more patient conditions” in line 6 in which there is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites “operate the vortex mixer” in line 27, but it is not clear if this recitation is the same as, related to, or different from the recited function “to mix the patient sample with the buffer extraction solution to generate a mixture” of claim 1, lines 9-10. The two recitations seem like they are related, but the claim does not link them together in any meaningful way. This ambiguity renders claim 1 indefinite.
Claim 1 recites “operate the conveyor belt” in line 28, but it is not clear if this recitation is the same as, related to, or different from the recited functions of “receive the test strip at a first location within the kiosk; transfer the test strip from the first location to a second location within the kiosk; and transfer the test strip from the second location to a third location within the kiosk” of claim 1, lines 12-16. The two recitations seem like they are related, but the claim does not link them together in any meaningful way. This ambiguity renders claim 1 indefinite.
Claim 1 recites “operate the robotic pipette module” in line 29, but it is not clear if this recitation is the same as, related to, or different from the recited functions “to retrieve the pipette tip from the second chamber and dispense at least a portion of the mixture onto the test strip using the pipette tip while the test strip is located at the second location” of claim 1, lines 17-19. The two recitations seem like they are related, but the claim does not link them together in any meaningful way. This ambiguity renders claim 1 indefinite.
Claim 1 recites “operate the imaging system” in line 30, but it is not clear if this recitation is the same as, related to, or different from the recited function “to capture an image of the test strip while the test strip is located at the third location” of claim 1, lines 20-21. The two recitations seem like they are related, but the claim does not link them together in any meaningful way. This ambiguity renders claim 1 indefinite.
Claim 1 recites “operate the display” in line 34, but it is not clear if this recitation is the same as, related to, or different from the recited function “to display instructions regarding using the test cartridge, the test strip, or the kiosk” of claim 1, lines 22-23. The two recitations seem like they are related, but the claim does not link them together in any meaningful way. This ambiguity renders claim 1 indefinite.
Claims 2-18 are rejected by virtue of their dependence from claim 1.
Claim 3 recites “one or more components of the test cartridge” in line 2, but it is not clear if this recitation is the same as, related to, or different from “a first chamber configured to store a patient sample and a buffer extraction solution” of claim 1, lines 3-4 and/or “a second chamber configured to store a pipette tip” of claim 1, line 5. The relationship among these recitations should be made clear.
Claim 5 recites “test cartridge” in line 1, but it is not clear if this recitation is the same as, related to, or different from “a test cartridge” of claim 1, line 2. If they are the same, “test cartridge” in claim 5 should be “the test cartridge”. If they are different, their relationship 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 recitation of “the test cartridge”, such as in claim 5, lines 2-3, should make it clear which recitation is being referred to.
Claim 5 recites “results of the image analysis performed by the processor” in line 4, but it is not clear if this recitation is the same as, related to, or different from the determination of whether at least one of the one or more patient conditions is present, as recited in claim 1, lines 32-33. The relationship between these two recitations should be made clear.
Claim 6 recites “the conveyor belt receiving the test strip at the first location comprises receiving the test cartridge at the first location; the conveyor belt transferring the test strip from the first location to the second location comprises transferring the test cartridge from the first location to the second location; and the conveyor belt transferring the test strip from the second location to the third location comprises transferring the test cartridge from the second location to the third location” in lines 3-8, which reads as method steps 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)).
Claim 7 recites “first chamber” in line 6, but it is not clear if this recitation is the same as, related to, or different from “a first chamber” of claim 1, line 3. If they are the same, “first chamber” in claim 7 should be “the first chamber”. If they are different, their relationship should be made clear and 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).
Claim 8 recites “wherein retrieving the wash buffer using the pipette tip comprises retrieving the wash buffer from the third chamber using the pipette tip” in lines 2-3, which reads as a method 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)).
Claim 10 recites “a test strip” in line 2, but it is not clear if this recitation is the same as, related to, or different from “a test strip” of claim 1, line 6. If they are the same, “a test strip” in claim 10 should be “the test strip”. If they are different, their relationship between these two recitations should be made clear and 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).
Claim 10 recites “test cartridge” in line 2, but it is not clear if this recitation is the same as, related to, or different from “a test cartridge” of claim 1, line 2. If they are the same, “test cartridge” in claim 10 should be “the test cartridge”. If they are different, their relationship between these two recitations should be made clear and 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).
Claim 11 recites “wherein the robotic pipette module comprises: one or more linear actuators configured to translate along one or more cartesian coordinate directions; and one or more rotational actuators configured to rotate about one or more rotational axes” in lines 1-4, but it is not clear what relationship these components have with the claimed functions which are ascribed to the robotic pipette module in claim 1, lines 17-19. This ambiguity renders claim 11 indefinite.
Claim 14 recites “wherein the one or more external computing devices comprise a cloud-based storage unit” in lines 1-2, but it is not clear if this recitation is part of the claimed system. Claim 13 from which claim 14 depends connotes that the one or more external computing devices is not part of the claim invention while the recitation of claim 14 connotes that it is. This ambiguity renders claim 14 indefinite. Also, if the one or more external computing devices is not part of the claimed system, it is not clear what the meaning of the recitation of claim 14 is since it further defines an element that is not part of the claimed invention. This creates confusion as to the metes and bounds of the claim, which renders claim 14 indefinite.
Claim 14 recites “results of the image analysis performed by the processor” in line 4, but it is not clear if this recitation is the same as, related to, or different from the determination of whether at least one of the one or more patient conditions is present, as recited in claim 1, lines 32-33. The relationship between these two recitations should be made clear.
Claim 14 recites “wherein communicating with the one or more external computing devices comprises providing, to the cloud-based storage unit: results of the image analysis performed by the processor; a test cartridge number associated with the test cartridge; a test order number; or a self-testing kit identification number” in lines 2-7, which reads as a method 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)).
Claim 15 recites “wherein the kiosk communicates with the one or more external computing devices over the network according to a protocol that complies with one or more privacy regulations” in lines 1-3, which is a method step in a system 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)).
Claim 16 recites “wherein the one or more computing devices comprises a computing device of a patient associated with the patient sample or a computing device associated with a physician of the patient associated with the patient sample” in lines 1-3, but it is not clear if this recitation is part of the claimed system. Claim 13 from which claim 16 depends connotes that the one or more external computing devices is not part of the claim invention while the recitation of claim 16 connotes that it is. This ambiguity renders claim 16 indefinite. Also, if the one or more external computing devices is not part of the claimed system, it is not clear what the meaning of the recitation of claim 16 is since it further defines an element that is not part of the claimed invention. This creates confusion as to the metes and bounds of the claim, which renders claim 16 indefinite.
Claim 17 recites “wherein the network comprises the public Internet” in line 1, but it is not clear if this recitation is part of the claimed system. Claim 13 from which claim 17 depends connotes that the network is not part of the claim invention while the recitation of claim 17 connotes that it is. This ambiguity renders claim 17 indefinite. Also, if the network is not part of the claimed system, it is not clear what the meaning of the recitation of claim 17 is since it further defines an element that is not part of the claimed invention. This creates confusion as to the metes and bounds of the claim, which renders claim 17 indefinite.
Claim 17 recites “the public Internet” in line 1 in which there is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites “wherein the test cartridge comprises: a first chamber configured to store the patient sample and the buffer extraction solution; and a second chamber configured to store a pipette tip” in lines 4-7, but it is not clear if this recitation is part of the claimed system. The recitation “A kiosk configured to receive and process a test cartridge and a test strip” of claim 19, line 1 connotes that the test cartridge is not part of the claim invention while the recitation of claim 19, lines 4-7 connotes that it is. This ambiguity renders claim 19 indefinite. Also, if the test cartridge is not part of the claimed system, it is not clear what the meaning of the recitation of claim 19 is since it further defines an element that is not part of the claimed invention. This creates confusion as to the metes and bounds of the claim, which renders claim 19 indefinite.
Claim 19 recites “the presence of one or more patient conditions” in line 10 in which there is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites “operate the vortex mixer” in line 24, but it is not clear if this recitation is the same as, related to, or different from the recited function “to mix a patient sample with a buffer extraction solution to generate a mixture” of claim 19, lines 3-4. The two recitations seem like they are related, but the claim does not link them together in any meaningful way. This ambiguity renders claim 19 indefinite.
Claim 19 recites “operate the conveyor belt” in line 25, but it is not clear if this recitation is the same as, related to, or different from the recited functions of “receive the test strip at a first location within the kiosk, wherein the test strip is usable to indicate the presence of one or more patient conditions; transfer the test strip from the first location to a second location within the kiosk” of claim 19, lines 9-13. The two recitations seem like they are related, but the claim does not link them together in any meaningful way. This ambiguity renders claim 19 indefinite.
Claim 19 recites “operate the robotic pipette module” in line 26, but it is not clear if this recitation is the same as, related to, or different from the recited functions “to retrieve the pipette tip from the second chamber and dispense at least a portion of the mixture onto the test strip using the pipette tip while the test strip is located at the second location” of claim 19, lines 14-16. The two recitations seem like they are related, but the claim does not link them together in any meaningful way. This ambiguity renders claim 19 indefinite.
Claim 19 recites “operate the imaging system” in line 27, but it is not clear if this recitation is the same as, related to, or different from the recited function “to capture an image of the test strip while the test strip is located at the third location” of claim 19, lines 17-18. The two recitations seem like they are related, but the claim does not link them together in any meaningful way. This ambiguity renders claim 19 indefinite.
Claim 19 recites “operate the display” in line 31, but it is not clear if this recitation is the same as, related to, or different from the recited function “to display instructions regarding using the test cartridge, the test strip, or the kiosk” of claim 19, lines 19-20. The two recitations seem like they are related, but the claim does not link them together in any meaningful way. This ambiguity renders claim 19 indefinite.
Claim 20 recites “the presence of one or more patient conditions” in lines 6-7 in which there is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites “a memory” in line 26, but it is not clear if this recitation is the same as, related to, or different from “a memory” of claim 20, line 24. If they are the same, “a memory” in line 26 should be “the memory”. If they are different, their relationship between these two recitations should be made clear and 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).
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 and 6-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2014/0234949 (Wasson), in view of WO85/03571 (Hulette), and further in view of U.S. Patent No. 5,209,903 (Kanamori).
Wasson teaches the use of a mixing apparatus (paragraphs 0232-0233, 0254, 0408, 0429, 0444, 0490, 0696, 0980-0981, and 1229 of Wasson). Hulette teaches a method of mixing in the form of vortex mixing (abstract and page 6-7 and 17 of Hulette). 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 vortex mixing of Hulette as the mixing apparatus of Wasson since (1) it is a simple substitution of one known element for another to obtain predictable results and/or (2) it provides a thorough mixing of the sample (page 17 of Hulette).
Wasson teaches a module-level sample handling system configured to transport items within a module (paragraph 1837 of Wasson). Further, Wasson teaches that a module may include a sample preparation station 310, an assay station 320, a detection station 330, and a fluid handling system 340 (paragraph 0478 and FIG. 3 of Wasson). Kanamori teaches a transport system in the form of a conveyor belt 108 (FIG 7 and col. 9, lines 10-30 of Kanamori). 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 conveyor belt of Kanamori as the transport system of Wasson to be used between stations in a module since (1) it is a simple substitution of one known element for another to obtain predictable results and/or (2) Wasson teaches that a transport system is used and Kanamori teaches one such transport system.
With respect to claim 1, the combination teaches or suggests a system comprising:
a test cartridge (the cartridge of Wasson; paragraphs 0238-0239, 0255, 0260-0262, 0266-0267, 0271, 0394-0404, 0406, 0411-0416, 0419-0423, 0426-0429, 0433-0451, 0465, 0480-0483, and 1198 of Wasson; FIGS. 75-84 of Wasson) comprising: a first chamber configured to store a patient sample (the biological sample of Wasson; paragraphs 0075, 0238, 0255, 0260-0262, 0266-0267, 0394-0404, 0411-0416, and 0444 of Wasson) and a buffer extraction solution (the buffer solutions of Wasson; paragraphs 0438, 0443, 0444, 0446, 1221, 1538, and 1557 of Wasson; the vessel in which the samples and reagents are mixed (paragraph 0444 of Wasson) with buffers considered to be such reagents (paragraphs 0446, 0449, and 1221 of Wasson)); and a second chamber configured to store a pipette tip (the pipette tips of Wasson; paragraphs 0260, 0397, 1922, 1947, and 1960 of Wasson);
a test strip usable to indicate the presence of one or more patient conditions (the test trip of Wasson; paragraphs 0397 and 1022-1033 of Wasson); and
a kiosk configured to receive and process the test cartridge and the test strip, wherein the kiosk comprises:
a vortex mixer configured to mix the patient sample with the buffer extraction solution to generate a mixture (the vortex mixing of Hulette in the fluid handling system of Wasson; paragraphs 0232-0233, 0254, 0408, 0429, 0444, 0490, 0696, 0980-0981, and 1229 of Wasson);
a conveyor belt configured to: receive the test strip at a first location within the kiosk; transfer the test strip from the first location to a second location within the kiosk; and transfer the test strip from the second location to a third location within the kiosk (the conveyor belt of Kanamori for transporting between stations in the module of Wasson);
a robotic pipette module configured to retrieve the pipette tip from the second chamber and dispense at least a portion of the mixture onto the test strip using the pipette tip while the test strip is located at the second location (the robotic arm of Wasson; paragraphs 0471, 0588, 0795, and 0890 of Wasson);
an imaging system configured to capture an image of the test strip while the test strip is located at the third location (the imaging device of Wasson; paragraphs 0030, 0082, 0102, 0156-0160, 0225-0231, 0488, 0519-520, 0848, 1364-1402 of Wasson);
a display configured to display instructions regarding using the test cartridge, the test strip, or the kiosk (paragraphs 0211, 0688, 1448-1451, and 1709 of Wasson); and
a processor communicatively coupled to the vortex mixer, the conveyor belt, the robotic pipette module, the imaging system, and the display, wherein the processor is configured to execute instructions stored within a memory to: operate the vortex mixer; operate the conveyor belt; operate the robotic pipette module; operate the imaging system; receive the image of the test strip from the imaging system; analyze the image of the test strip to determine whether at least one of the one or more patient conditions is present; and operate the display (the processor of Wasson; paragraphs 0162-0165, 0170, 0185, 0230, 0250, 0252-0253, 0256-0270, 0394, 0430, 0612, 0689, 0878-0879, 1394, 1427, 1435, 1475-1476, 1500-1501, 1507, 1509, 1713 of Wasson as modified to operate the conveyor belt of Kanamori and the vortex mixing of Hulette).
With respect to claim 6, the combination teaches or suggests that the test strip is configured to be stored within the test cartridge (the test strip of Wasson is so stored; paragraphs 0397 and 1022-1033 of Wasson), and wherein: the conveyor belt receiving the test strip at the first location comprises receiving the test cartridge at the first location; the conveyor belt transferring the test strip from the first location to the second location comprises transferring the test cartridge from the first location to the second location; and the conveyor belt transferring the test strip from the second location to the third location comprises transferring the test cartridge from the second location to the third location (the operation of the conveyor belt of Kanamori for transporting between stations in the module of Wasson).
With respect to claim 7, the combination teaches or suggests that the conveyor belt is further configured to, upon the imaging system capturing the image of the test strip while the test strip is located at the third location, transfer the test cartridge from the third location to the second location, and wherein the robotic pipette module is further configured to: retrieve a wash buffer using the pipette tip; and dispense the wash buffer into first chamber using the pipette tip (the operation of the conveyor belt of Kanamori for transporting between stations in the module of Wasson and the operation of the robotic arm of Wasson; paragraphs 0408, 0438, 0446, 0471, 0588, 0625, 0686, 0696, 0795, 0890, 1194, 1210, 1221, 1240-1249, 1328, 1404, and 1788-1789 of Wasson).
With respect to claim 8, the combination teaches or suggests that the test cartridge further comprises a third chamber configured to store the wash buffer, and wherein retrieving the wash buffer using the pipette tip comprises retrieving the wash buffer from the third chamber using the pipette tip (paragraphs 0408, 0438, 0446, 0471, 0588, 0625, 0686, 0696, 0795, 0890, 1194, 1210, 1221, 1240-1249, 1328, 1404, and 1788-1789 of Wasson).
With respect to claim 9, the combination teaches or suggest that the first chamber comprises a vial configured to store the patient sample and the buffer extraction solution (the vessel in which the samples and reagents are mixed (paragraph 0444 of Wasson) with buffers considered to be such reagents (paragraphs 0446, 0449, and 1221 of Wasson)), and wherein the vial comprises a self-sealing cap (the resealable membrane of Wasson; paragraphs 1034-1036, 1967, and 1969 of Wasson).
With respect to claim 10, the combination teaches or suggests that the conveyor belt comprises a plurality of slots (the slots 112 formed by the protrusions 110 Kanamori), and wherein each slot of the plurality of slots is configured to hold a test strip or test cartridge (col. 7, lines 45-55 of Kanamori).
With respect to claim 11, the combination teaches or suggests that the robotic pipette module comprises: one or more linear actuators configured to translate along one or more cartesian coordinate directions; and one or more rotational actuators configured to rotate about one or more rotational axes (the robotic arm of Wasson that movies horizontally, vertically, and rotationally using linear and rotational actuation mechanisms; paragraphs 0111, 0140, 0471, 0588-0589, 0595, 0708, 0755-0756, 0795, 0799, and 0890 of Wasson).
With respect to claim 12, the combination teaches or suggests that the imaging system comprises: one or more light-emitting diodes (LEDs)(the LEDs of Wasson; paragraphs 0860, 1350, 1355, and 1377 of Wasson); and one or more cameras (the cameras of Wasson; paragraphs 0030, 0083, 0153, 0183, 0394, 0488, 0533, 0588, 0848, 0874, 1367, 1370-1375, 1390, and 1394-1402 of Wasson).
With respect to claim 13, the combination teaches or suggests that the kiosk further comprises a communication interface configured to communicate with one or more external computing devices over a network (paragraphs 0089, 0318, 0579, 0601, 0616, 0655-0657, 1428, 1464-1468, 1479-1487, 1503, 1509, 1517, 1540, 1605, 1613, 1633, 1680, 1692, and 1706 of Wasson).
With respect to claim 14, the combination teaches or suggests that the one or more external computing devices comprise a cloud-based storage unit (paragraphs 0394, 0656, 0668, 0673, 0676, 1380, 1412, 1430, 1452, 1462, 1489, 1505, 1509, 1587, 1628, 1655, 1663-1664, 1689, 1692, 1706, 1708, and 1710-1711 of Wasson), and wherein communicating with the one or more external computing devices comprises providing, to the cloud-based storage unit: results of the image analysis performed by the processor; a test cartridge number associated with the test cartridge; a test order number; or a self-testing kit identification number (paragraphs 0261-0262, 0394, 0483, 0606, 0656, 0668, 0673, 0676, 0686, 1380, 1404, 1412, 1430, 1452, 1462, 1466, 1489, 1505, 1509, 1587, 1628, 1655, 1663-1664, 1469-1478, 1689, 1692, 1706, 1708, and 1710-1711 of Wasson).
With respect to claim 15, the combination teaches or suggests that the kiosk communicates with the one or more external computing devices over the network according to a protocol that complies with one or more privacy regulations (paragraphs 0261, 0529, 1463, and 1711 of Wasson).
With respect to claim 16, the combination teaches or suggests that the one or more computing devices comprises a computing device of a patient associated with the patient sample or a computing device associated with a physician of the patient associated with the patient sample (paragraphs 0117, 0184, 0381, 1515-1516, 1599, 1649-1650, 1661, 1665-1676, and 1679-1681 of Wasson).
With respect to claim 17, the combination teaches or suggests that the network comprises the public Internet (paragraphs 0615, 0655-0656, 1464, 1480, 1482, 1485, and 1633 of Wasson).
With respect to claim 18, the combination teaches or suggests that the robotic pipette module comprises a plunger configured to engage the vortex mixer to cause the vortex mixer to mix the patient sample with the buffer extraction solution to generate the mixture (paragraphs 0095-0096, 0098-0099, 0105, 0107, 0112-0116, 0128-0141, 0148, 0439, 0490, 0696-0698, 0719, 0794, 1192, 1925, 1928-1946, and 1969-1970 of Wasson suggests using the pipette with its plunger for mixing and it would have been obvious to do so for more thorough mixing).
With respect to claim 19, the combination teaches or suggests a kiosk configured to receive and process a test cartridge and a test strip, wherein the kiosk comprises:
a vortex mixer configured to mix a patient sample with a buffer extraction solution to generate a mixture (the vortex mixing of Hulette in the fluid handling system of Wasson; paragraphs 0232-0233, 0254, 0408, 0429, 0444, 0490, 0696, 0980-0981, and 1229 of Wasson), wherein the test cartridge comprises: a first chamber configured to store the patient sample and the buffer extraction solution; and a second chamber configured to store a pipette tip (the compartments for the biological sample, the buffer solutions, and the pipette tips of Wasson; paragraphs 0075, 0238, 0255, 0260-0262, 0266-0267, 0394-0404, 0411-0416, 0438, 0443-0444, 0446, 0449, 1221, 1538, 1557, 1922, 1947, and 1960 of Wasson);
a conveyor belt (the conveyor belt of Kanamori for transporting between stations in the module of Wasson) configured to: receive the test strip at a first location within the kiosk, wherein the test strip is usable to indicate the presence of one or more patient conditions; transfer the test strip from the first location to a second location within the kiosk; and transfer the test strip from the second location to a third location within the kiosk;
a robotic pipette module (the robotic arm of Wasson; paragraphs 0471, 0588, 0795, and 0890 of Wasson) configured to retrieve the pipette tip from the second chamber and dispense at least a portion of the mixture onto the test strip using the pipette tip while the test strip is located at the second location;
an imaging system (the imaging device of Wasson; paragraphs 0030, 0082, 0102, 0156-0160, 0225-0231, 0488, 0519-520, 0848, 1364-1402 of Wasson) configured to capture an image of the test strip while the test strip is located at the third location;
a display configured to display instructions regarding using the test cartridge, the test strip, or the kiosk (paragraphs 0211, 0688, 1448-1451, and 1709 of Wasson); and
a processor communicatively coupled to the vortex mixer, the conveyor belt, the robotic pipette module, the imaging system, and the display, wherein the processor is configured to execute instructions stored within a memory to: operate the vortex mixer; operate the conveyor belt; operate the robotic pipette module; operate the imaging system; receive the image of the test strip from the imaging system; analyze the image of the test strip to determine whether at least one of the one or more patient conditions is present; and operate the display (the processor of Wasson; paragraphs 0162-0165, 0170, 0185, 0230, 0250, 0252-0253, 0256-0270, 0394, 0430, 0612, 0689, 0878-0879, 1394, 1427, 1435, 1475-1476, 1500-1501, 1507, 1509, 1713 of Wasson as modified to operate the conveyor belt of Kanamori and the vortex mixing of Hulette).
With respect to claim 20, the combination teaches or suggests a method comprising:
receiving, by a kiosk, a test cartridge (receiving the cartridge of Wasson; paragraphs 0238-0239, 0255, 0260-0262, 0266-0267, 0271, 0394-0404, 0406, 0411-0416, 0419-0423, 0426-0429, 0433-0451, 0465, 0480-0483, and 1198 of Wasson; FIGS. 75-84 of Wasson) comprising: a first chamber configured to store a patient sample (the biological sample of Wasson; paragraphs 0075, 0238, 0255, 0260-0262, 0266-0267, 0394-0404, 0411-0416, and 0444 of Wasson) and a buffer extraction solution (the buffer solutions of Wasson; paragraphs 0438, 0443, 0444, 0446, 1221, 1538, and 1557 of Wasson); and a second chamber configured to store a pipette tip (the pipette tips of Wasson; paragraphs 0260, 0397, 1922, 1947, and 1960 of Wasson);
receiving, by the kiosk, a test strip (receiving the test trip of Wasson; paragraphs 0397 and 1022-1033 of Wasson) usable to indicate the presence of one or more patient conditions;
displaying, by a display of the kiosk, instructions regarding using the test cartridge, the test strip, or the kiosk (displaying of instructions; paragraphs 0211, 0688, 1448-1451, and 1709 of Wasson); and
processing, by the kiosk, the test cartridge and the test strip, wherein processing the test cartridge and the test strip comprises:
mixing, by a vortex mixer, the patient sample with the buffer extraction solution to generate a mixture (the vortex mixing of Hulette in the fluid handling system of Wasson; paragraphs 0232-0233, 0254, 0408, 0429, 0444, 0490, 0696, 0980-0981, and 1229 of Wasson);
receiving, by a conveyor belt, the test strip at a first location within the kiosk (the conveyor belt of Kanamori for transporting between stations in the module of Wasson);
transferring, by the conveyor belt, the test strip from the first location to a second location within the kiosk (the conveyor belt of Kanamori for transporting between stations in the module of Wasson);
retrieving, by a robotic pipette module, the pipette tip from the second chamber (the robotic arm of Wasson retrieving the pipette tip; paragraphs 0471, 0588, 0795, and 0890 of Wasson);
dispensing, by the robotic pipette module, at least a portion of the mixture onto the test strip using the pipette tip while the test strip is located at the second location (dispensing by the pipette tip; paragraphs 0097, 0104, 0110, 0117, 0120, 0150, 0152, 0154, 0168, and 1320 of Wasson);
transferring, by the conveyor belt, the test strip from the second location to a third location within the kiosk (the conveyor belt of Kanamori for transporting between stations in the module of Wasson);
capturing, using an imaging system, an image of the test strip while the test strip is located at the third location (using the imaging device of Wasson; paragraphs 0030, 0082, 0102, 0156-0160, 0225-0231, 0488, 0519-520, 0848, 1364-1402 of Wasson);
receiving, by a processor executing instructions stored within a memory, the image of the test strip from the imaging system (receiving images from the imaging device of Wasson; paragraphs 0030, 0082, 0102, 0156-0160, 0225-0231, 0488, 0519-520, 0848, 1364-1402 of Wasson); and
analyzing, by the processor executing the instructions stored within a memory, the image of the test strip to determine whether at least one of the one or more patient conditions is present (analyzing image using the processor of Wasson; paragraphs 0082, 0162-0165, 0170, 0183, 0185, 0230, 0250, 0252-0253, 0256-0270, 0394, 0430, 0612, 0689, 0878-0879, 1323, 1363, 1370, 1379, 1390, 1394, 1400-1401, 1427, 1435, 1475-1476, 1500-1501, 1507, 1509, 1663-1664, 1713, and 1795 of Wasson).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Wasson, in view of Hulette, and further in view of Kanamori, and further in view of U.S Patent Application Publication No. 2010/0020309 (Goldberger) and U.S. Patent No. 5,888,826 (Ostgaard).
The combination teaches or suggests a receiving, by a kiosk, a test cartridge (receiving the cartridge of Wasson; paragraphs 0238-0239, 0255, 0260-0262, 0266-0267, 0271, 0394-0404, 0406, 0411-0416, 0419-0423, 0426-0429, 0433-0451, 0465, 0480-0483, and 1198 of Wasson; FIGS. 75-84 of Wasson).
Wasson teaches that the whole cartridge may be sealed (paragraph 0446 of Wasson). Goldberger teaches a hermetically seal over a cartridge and/or include humidity controls means, such as, but not limited to a small bag of desiccant material (paragraph 0118 of Goldberger). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to hermetically seal the cartridge of the combination so as to ensure protection for the cartridge from environmental elements. Goldberger teaches that humidity controls may be used (paragraph 0118 of Goldberger). Ostgaard teaches that desiccant may be place on the seal (col. 7, lines 30-45 of Ostgaard). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use desiccant on the hermetic seal since (1) it is a simple substitution of one known element for another to obtain predictable results and (2) Goldberger suggests of humidity control means may be used and Ostgaard teaches one such humidity control means.
With respect to claim 2, the combination teaches or suggest that the test cartridge comprises an ergonomic shell (the hermetically seal suggested by Goldberger), wherein the ergonomic shell is made of moisture-impermeable material, and wherein the moisture-impermeable material comprises a seal layer (the hermetic material of the seal suggested by Goldberger) and a desiccant (the desiccant suggested by Ostgaard).
With respect to claim 3, Wasson teaches that seals are broken using a pipette (paragraph 0986 of Wasson). 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 pipette controlled by the robotic pipette module so as to break the hermetic seal since it permits access to the components of the cartridge of the combination. Thus, the combination teaches or suggest that the robotic pipette module is configured to pierce the seal layer in order to access one or more components of the test cartridge.
With respect to claim 4, the combination teaches or suggest that the test strip is configured to be stored within the test cartridge (the test strip of Wasson is so stored; paragraphs 0397 and 1022-1033 of Wasson), and wherein the seal layer is configured to encapsulate the test strip (the hermetically seal suggested by Goldberger).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Wasson, in view of Hulette, and further in view of Kanamori, and further in view of U.S Patent Application Publication No. 2004/0161368 (Holtlund) and U.S. Patent Application Publication No. 2009/0130745 (Williams).
Holtlund teaches the use of a bar-code placed on an assay cartridge and, reading this the computer running the apparatus can identify the nature of the assay and hence the assay steps necessary to effect use. The bar-code is used to also identify the patient so that the apparatus may generate a report identifying the patient and assay or may generate an entry in or for the patient’s computerized records (paragraph 0067 of Holtlund). Williams teaches that a part number may be one such identification (paragraph 0690 of Williams). 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 bar-code placed on an assay cartridge and having it linked to the computer such that the device can identify the nature of the assay, using the part number of Williams, and hence identify the assay steps necessary so as to effect use, identify the patient so as to generate a report identifying the patient and assay, and identify the patient so as to generate an entry in or for the patient’s computerized records since it ensures efficient operation relative to the cartridge and ensures that the results are ascribed to the correct patient.
Williams discloses the use of a bar-code for the identification of the cartridge which includes the cartridge type, the lot number, and the expiry date (paragraph 0449 of Williams). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the bar-code placed on an assay cartridge and having it linked to the computer such that the device can identify the cartridge type, the lot number, and the expiry date since it helps to track the testing equipment used to achieved the results for the patient.
Williams also teaches that the bar code may include a quantity, an expiration date, an optical UPC code, and storage limits (paragraph 0690-0691 of Williams). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the bar-code having information with respect to a quantity, an expiration date, an optical UPC code, and storage limits and having it linked to the computer since it helps to track the testing equipment used to achieved the results.
With respect to claim 5, the combination teaches or suggests that the test cartridge comprises an external label (the bar-code of Holtlund), wherein the external label comprises a barcode indicative of a test cartridge number associated with the test cartridge (the lot number of Williams), a test order number (the number with respect a quantity, an expiration date, an optical UPC code, and storage limits of Williams), and a test kit identification number (the part number of the cartridge for identifying the nature of the assay), and wherein the test cartridge number is usable to link results of the image analysis performed by the processor to a patient associated with the patient sample (the bar-code linked to the results of the patient; paragraph 0067 of Holtlund).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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