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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-13, 15 and 18-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thatcher et al. (US 2017/0122851).
Regarding claim 1, Thatcher discloses an apparatus for analyzing a bodily sample, the apparatus comprising:
a sample carrier (fig. 1, ref. 510) configured to house the bodily sample (the bodily sample is not positively claimed and can be added at a later time to the sample carrier), the sample carrier comprising at least one fluidic channel (see fig. 1, anyone of the numerous channels), at least one analysis chamber (fig. 1 ref. 582), and
a receptacle that houses a diluent (injection channels 515c to 515f house fluids that are moved to various chambers to aid in PCR analysis, para 60-61); and
a pump system (pneumatic pressure system which pumps fluid from blister packs to various other channels and chamber, para 55. A bladder assembly is pressed against the face of the sample carrier and uses pressure to move fluid throughout the samlple carrier via the bladder assembly 810) configured to: pump the diluent from the receptacle into the fluidic channel in a first fluid flow direction, and subsequently, pump the diluent and the bodily sample in a second fluid flow direction, which is a reverse of the first fluid flow direction, to thereby mix the diluent and the bodily sample within the receptacle (this limitation is drawn to a process/intended use limitation and does not further structurally limit the instant claim. The bodily sample is not positively recited as being part of the instant claim and can be added to the sample carrier at a later time. Further the pump system of Thatcher is structurally capable of performing the above intended use as seen in para. 62-63).
Regarding claim 2, the apparatus according to claim 1, wherein the sample carrier is configured to be placed within an optical measurement unit that is configured to perform an optical measurement upon the bodily sample while the sample carrier is disposed within the optical measurement unit (the optical measurement unit is not positively recited in the instant claims. The sample carrier can be placed into or within an optical measurement unit at a later time), and wherein the pump system is disposed within the optical measurement unit (Applicant is urged to claim an optical measurement unit that houses a pump system. The instant limitation allows for the pump system to be disposed within an optical measurement unit which is not positively recited at a later time).
Regarding claim 3, the apparatus according to claim 1, wherein the fluidic channel and the receptacle are configured such that, as the diluent and the bodily sample are pumped in the second fluid flow direction, the diluent and the bodily sample are pumped from a smaller cross-sectional area within the fluidic channel into a larger cross-sectional area within the receptacle, thereby enhancing mixing of the diluent and the bodily sample (this limitation is drawn to a process/intended use limitation which does not further structurally limit the instant claim. Applicant is urged to claim a structural difference from the prior art. Thatcher discloses various channels, chamber having various cross sectional areas where fluid flow to and from in order for mixing. See fig. 1).
Regarding claim 4, the apparatus according to claim 1, wherein the fluidic channel is configured such that, as the diluent and the bodily sample are pumped in the first fluid flow direction, the diluent and the bodily sample are pumped from a smaller cross-sectional area within the fluidic channel into a larger cross-sectional area within the fluidic channel, thereby enhancing mixing of the diluent and the bodily sample (this limitation is drawn to a process/intended use limitation which does not further structurally limit the instant claim. Applicant is urged to claim a structural difference from the prior art. Thatcher discloses various channels, chamber having various cross sectional areas where fluid flow to and from in order for mixing. See fig. 1).
Regarding claim 5, the apparatus according to claim 1, wherein the receptacle comprises a blister pack (see fig. 1, para 52) and wherein the sample carrier comprises a needle (pneumatic pressure point) that is configured to release the diluent from the blister pack, by piercing the blister pack.
Regarding claim 6, the apparatus according to claim 5, wherein the blister pack is disposed at an angle within the sample carrier (see fig. 1-2) such that the blister pack acts as a bubble trap, by preventing air from being pumped from the blister pack (this limitation does not further structurally limit the instant claim).
Regarding claim 7, the apparatus according to claim 5, wherein the needle is hollow and the fluidic channel extends through the needle (see fig. 2).
Regarding claim 8, the apparatus according to claim 5, wherein the sample carrier comprises a cap (802) and a main body (see fig. 2, 5, main body 810), wherein the blister pack (810 has various blister packs within) is disposed within the main body, and wherein the needle is coupled to the cap and is configured to pierce the blister pack as the cap is coupled to the main body of the sample carrier (see fig. 2, pneumatic pressure actuators).
Regarding claim 9, the apparatus according to claim 8, wherein the fluidic channel extends from the blister pack through the cap and back into the main body of the sample carrier (see fig. 2).
Regarding claim 10, the apparatus according to claim 9, further comprising one or more stains (any buffer or reagent that is provided within the sample carrier that are configured to stain the bodily sample and that are disposed within the cap, wherein the cap is configured such that as the diluent flows out of the blister pack, the diluent mixes with the stain and the diluent and the stain mix with the bodily sample (this limitation is drawn to a process/intended use limitation which does not further structurally limit the instant claim. Applicant is urged to claim a structural difference from the prior art. Thatcher discloses various channels, chamber having various cross sectional areas where fluid flow to and from in order for mixing. See fig. 1).
Regarding claim 11, Thatcher discloses an apparatus for analyzing a bodily sample, the apparatus comprising:
a sample carrier (510) configured to house the bodily sample (the bodily sample is not positively recited as being part of the sample carrier and can be added at a later time), the sample carrier comprising at least one fluidic channel (see fig. 1, which shows various fluidic channels and chambers), and at least one analysis chamber (580); and
an optical measurement unit (see fig. 2) comprising:
a stage (802) that is configured to hold the sample carrier (510);
an optical measurement device (890) that is configured to perform optical measurements on a portion of the bodily sample that is disposed in the analysis chamber, when the sample carrier is held by the stage (stage 802 provides a support for the sample carrier 510 as seen in fig. 5); and a pump system (810) comprising one or more pumps that are configured to pump the bodily sample through the fluidic channel (a pneumatic pumping systems moves fluid from blister packs to various chambers and channels in order to mix sample with buffer/reagents and then to an analysis chamber to detect a reaction; para 52).
Regarding claim 12, the apparatus according to claim 11, wherein the pump system is configured to apply any one of ambient pressure, positive pressure, vacuum pressure, or to apply no pressure to the fluidic channel (this limitation does not further structurally limit the instant claim because there is not structure recited that performs the recited functions).
Regarding claim 13, the apparatus according to claim 11, wherein the sample carrier comprises a microscope analysis chamber (580) and a first fluidic channel (565) that extends to the microscope analysis chamber, and wherein the optical measurement device (890) comprises a microscope (camera 896) configured to image a first portion of the bodily sample, when the first portion of the bodily sample is disposed within the microscopic analysis chamber (the reaction mixture comprises the bodily sample with a reagent).
Regarding claim 15, the apparatus according to claim 13, wherein:
the sample carrier (fig. 1) comprises an optical-density-analysis chamber (566) and a second fluidic channel (562) that extends to the optical-density-analysis chamber; the optical measurement device further comprises an optical-density-measurement device (the optical array 890 can move to image various parts of the sample carrier) configured to perform optical density measurements on a second portion of the bodily sample, when the second portion of the bodily sample is disposed within the optical-density-analysis chamber; and the pump system is configured to pump the first and second portions of the bodily sample through the first and second fluidic channels respectively (this limitation is drawn to a process/intended use limitation and does not further structurally limit the instant claim).
Regarding claim 18, the apparatus according to claim 13, wherein the microscope analysis chamber comprises an inlet (565) and an outlet (top of chamber 580 there is a channel which leads to 515l), wherein the sample carrier comprises an additional fluidic channel (any of the fluidic channels shown in fig. 1), and wherein the pump system is configured to balance pressure between the inlet and the outlet of the microscope analysis chamber via the first fluidic channel and the additional fluidic channel (this limitation is drawn to a process/intended use limitation and does not further structurally limit the instant claim).
Regarding claim 19, the apparatus according to claim 18, wherein the pump system is configured to balance pressure between the inlet and the outlet of the microscope analysis chamber by exposing the first fluidic channel and the additional fluidic channel to atmospheric pressure (this limitation is drawn to a process/intended use limitation and does not further structurally limit the instant claim)..
Regarding claim 20, the apparatus according to claim 18, wherein the pump system is configured to balance pressure between the inlet and the outlet of the microscope analysis chamber by applying equal amounts of pressure via the first fluidic channel and the additional fluidic channel (this limitation is drawn to a process/intended use limitation and does not further structurally limit the instant claim).
Regarding claim 21, the apparatus according to claim 11, wherein the pump system comprises a volumetric pump system that comprises a piston (para 66, 68) that is configured to pump defined volumes of air through the fluidic channel.
Regarding claim 22, the apparatus according to claim 21, wherein the pump system comprises a relative pressure gauge (para 68) that is configured to measure pressure of a portion of the pump system relative to ambient pressure, and wherein the optical measurement unit comprises a computer processor that is configured to derive ambient pressure from the pressure that is measured by the relative pressure gauge (para 78, computer controls valves and pneumatic pressure being applied to sample carrier).
Regarding claim 23, the apparatus according to claim 22, wherein the computer processor (894) is configured to determine a volume that should be pumped by the piston in order to provide a desired pressure change, based upon the ambient pressure (para 66, 68).
Conclusion
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
