DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-17 are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by Chen et al. (US 2008/0280285).
Regarding claim 1, Chen discloses a system for identifying the presence, absence, and/or quantity of a molecule of interest in a sample, comprising:
a reader (developer/controls fig. 1-2); and
a cartridge (fig. 1-2, cassette), that fits into the reader (para 64), the cartridge configured to accept a sample collection device that fits into the cartridge (a sample collection device is not positively recited in the instant claim and is not given patentable weight. The cartridge has a sample inlet that is capable of accepting a sample collection device);
wherein the cartridge (fig. 26) comprises:
a first reservoir (14) for storing a liquid (buffer/dilution liquid and sample), wherein a mixture comprising the liquid (dilution liquid; para 121) and the sample (para 121) is formed in the first reservoir when the sample collection device having the sample is inserted into the first reservoir (this limitation is drawn to a process/ intended use limitation and does not further structurally limit the instant claim. The sample is not positively recited in the claim because it can be added at a later time. Para 121, states a sample and a dilution liquid are mixed in dilution chamber 14);
a second reservoir (30) for storing a chemical substrate (reagent storage chamber);
an analysis channel (detection zone 16, having a channel leading thereto) comprising an electrochemical sensor (para 70-71; 99; 114); and
a first phase change valve (20; para 72, 94) for sealing the mixture in the first reservoir from the analysis channel in solid state;
a second phase change valve (22; para 72,94; in a second interpretation there are various phase change valves downstream that control fluid flow through the cartridge as seen in fig. 7, rectangular boxes seen on cartridge) for sealing the chemical substrate in the second reservoir from the analysis channel in solid state; and
one or more heaters (para 94) disposed adjacent (para 65; heaters are provided on the cassette or on the developer but both instances they are adjacent the phase change valves in order to heat them in order open the valve to allow flow to occur; para 73, hydrogel valves opened by adjacent an heater) the first and second phase change valves for melting the first and second phase change valves to transfer the mixture and the chemical substrate to the analysis channel, wherein a reaction of the mixture and the chemical substrate is detected by the electrochemical sensor and communicated to the reader (this limitation is drawn to a process step/intended use and does not further structurally limit the instant claims. The prior art is structurally capable of performing this process as the phase change valves are controlled by a heater to move the mixture and reagent to a detection site downstream. Fig. 7 also shows the cartridge in a different embodiment with a plurality of thermoelectric units under each phase change valve);
a first via thermally coupling one of the one or more heaters to the first phase change valve (see fig. 7, 30, 33 which shows the cartridge having hydrogel valves which are opened when the heater placed below the cartridge and in contact with starts to heat the hydrogel above its transition temperature and opening the valve. Fig 33 shows two hydrogel valves with a heater under each. The via is broadly interpreted as just as a surface to which a heater can come into contact with hydrogel valve) ; and
a second via thermally coupling one of the one or more heaters to the second phase change valve (see fig. 7, 30, 33 which shows the cartridge having hydrogel valves which are opened when the heater placed below the cartridge and in contact with starts to heat the hydrogel above its transition temperature and opening the valve. Fig 33 shows two hydrogel valves with a heater under each. The via is broadly interpreted as just as a surface to which a heater can come into contact with hydrogel valve).
Regarding claim 2, the system of claim 1, wherein the mixture comprises a plurality of magnetic particle complexes, wherein each of the plurality of magnetic particle complexes comprises a magnetic particle (para 114).
Regarding claim 3, the system of claim 2, wherein the reader comprises a magnetic field generator (para 139) adjacent to the analysis channel when the cartridge fits into the reader, such that the plurality of magnetic particle complexes can be localized in the analysis channel within a magnetic field generated by the magnetic field generator.
Regarding claim 4, the system of claim 2, wherein the electrochemical sensor releases a flow of electrons in a quantity proportional to a number of the plurality of magnetic particle complexes localized in the analysis channel in response to reactions between the mixture and the chemical substrate (this limitation does not further structurally limit the instant claim because a sample or liquid is not positively claimed to which has electrons to be released in response to a reaction. The limitation is drawn to a process step/intended use limitation).
Regarding claim 5, the system of claim 1, wherein the molecule of interest comprises one or more of a nucleic acid, protein, or small molecule (para 4, claim 78).
Regarding claim 6, the system of claim 1, wherein the cartridge comprises a slot to allow for a permanent magnet to slide into place underneath the electrochemical sensor (see fig. 1-2).
Regarding claim 7, the system of claim 1, wherein the reader is configured to send or receive, or both, signals to a mobile device indicative of a test result (this limitation does not further structurally limit the instant claim because a structure that can send or receive signals is not claimed. A mobile device is not positively claimed in the instant claims).
Regarding claim 8, the system of claim 7, further comprising an application stored on the mobile device, the application configured to cause the mobile device to display the test result (A mobile device is not positively claimed as part of the system, therefore the application stored on the mobile device is not given patentable weight).
Regarding claim 9, the system of claim 1, wherein the reader is configured to send or receive, or both, signals to a mobile device indicative of a test protocol (this limitation does not further structurally limit the instant claim because a structure that can send or receive signals is not claimed. A mobile device is not positively claimed in the instant claims).
Regarding claim 10, the system of claim 3, wherein the magnetic field generator comprises a permanent magnet (para 64, 84).
Regarding claim 11, the system of claim 3, wherein the magnetic field generator comprises more than one magnet (para 64, 84).
Regarding claim 12, the system of claim 1, wherein first and second phase change valves consist of wax and the one or more heaters heat one or more vias to melt the wax (para 72-73).
Regarding claim 13, the system of claim 1, further comprising a sonicator configured to direct energy into the mixture in the first reservoir (para 105).
Regarding claim 14, the system of claim 1, further comprising a third reservoir for storing a wash solution (see fig. 7, various liquids, Etoh, AW1, AW2), wherein the one or more heaters facilitates transfer of the wash solution to the analysis channel (para 65).
Regarding claim 15, the system of claim 1, wherein the system further comprises the sample collection device, the sample collection device configured to collect the sample from blood, urine, or saliva (a pipette is used to apply a sample).
Regarding claim 16, the system of claim 1, wherein a first heater of the one or more heaters is thermally coupled to the first via, and a second heater of the one or more heaters is thermally coupled to the second via (see fig. 7, 30, 33 which shows the cartridge having hydrogel valves which are opened when the heater placed below the cartridge and in contact with starts to heat the hydrogel above its transition temperature and opening the valve. Fig 33 shows two hydrogel valves with a heater under each. The via is broadly interpreted as just as a surface to which a heater can come into contact with the cartridge).
Regarding claim 17, the system of claim 16, wherein the first via is thermally isolated from the second via such that the first phase change valve and the second phase change valve are independently meltable by the first heater and the second heater, respectively (see fig. 7, 30, 33 which shows the cartridge having hydrogel valves which are opened when the heater placed below the cartridge and in contact with starts to heat the hydrogel above its transition temperature and opening the valve. Fig 33 shows two hydrogel valves with a heater under each, both heater/valve being separate from the other. The via is broadly interpreted as just as a surface to which a heater can come into contact with hydrogel valve.
Response to Arguments
Applicant's arguments filed 7/7/26 have been fully considered but they are not persuasive. Applicant argues, “In fact, paragraphs [0072]-[0073] and the rest of Chen fail to include any specific mention of individual vias or thermally coupling such vias to either heaters or phase change valves, much less both items.” Broadly a via is interpreted as a surface to which a structure is in contact with another structure. In this instance a heater is provided adjacent and in contact with a hydrogel valve. This contact provides thermal coupling as heat is transferred from the heater to the hydrogel valve to raise the hydrogel past its transition temperature in order to open the valve.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL P SIEFKE whose telephone number is (571)272-1262. The examiner can normally be reached Monday-Friday 8-5.
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/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758
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