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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites, “a detector configured to detect a change in voltage” and detecting, with the detector, a change in voltage as the cell passes through the detection region”. The specification is silent regarding a detector configured to detect a change in voltage. Instead, the specification discloses a photodetector being configured to receive light and to generate an electrical signal, i.e. a voltage drop, upon a change in incident light produced by a particle passing through a flow path. The detector discloses in the specification does not directly measure voltage as it measuring the light intensity then outputs a signal which is directed to a voltage drop.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-5, 8 and 10-22 are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by Sharpe et al. (US 2011/0196637).
Regarding claim 1, Sharpe discloses an automated method for evaluating an activation state associated with a blood sample obtained from an individual, the method comprising:
delivering a stream of a portion of the blood sample toward a detection region of a flow channel comprising a detector configured for extracting a morphological parameter of a cell to detect a change in voltage as a cell passes through the detection region of the flow channel (para 38-41, flowing sample to detector, detector detecting cell morphology, the photodetector produces a signal upon a cell passing through a flow region which indicates a change in voltage, para. 71);
detecting, with the detector, a change in voltage as the cell passes through the detection region (para 71, photodetector voltage or gain);
determining a morphological parameter of the cell from at least the change in voltage (para 41);
determining, from a morphology dataset comprising the morphological parameter of the cell, a plurality of cell subpopulations of the blood sample (para 41,79, 90), and
evaluating, using a data processing module (para 94, 96, 6-11) determining the activation state associated with the blood sample based on the plurality of cell subpopulations (para 9-11 13).
Regarding claim 2, the method of claim 1, wherein the cell is a leukocyte (para 44).
Regarding claim 3, the method of claim 2, wherein the activation state associated with the blood sample is based at least in part on the morphological parameter of the leukocyte (para 44, 41).
Regarding claim 4, the method of claim 1, wherein the flow channel comprises a microfluidic channel (para 10, 42-43).
Regarding claim 5, the method of claim 1, wherein the stream of the portion of blood sample is focused via hydrodynamic focusing (para 43), sheath fluid, dielectrophoretic focusing, or magnetic focusing.
Regarding claim 8, the method of claim 1, wherein the detection module further detector comprises a photomultiplier (para 71).
Regarding claim 10, the method of claim 1, wherein the morphological parameter of the cell comprises a length of the cell, a width of the cell, a length to width ratio of the cell, an elastic modulus of the cell, a viscosity of the cell, a circularity of the cell, a roughness of the cell, a size of the cell, a volume of the cell, a diameter of the cell, an area of the cell, or a symmetry of the cell (see para 41 for list).
Regarding claim 11, the method of claim 1, wherein the plurality of cell subpopulations comprises an activated leukocyte subpopulation (para 50,70,90).
Regarding claim 12, the method of claim 1, further comprising displaying a plot of the plurality of cell subpopulations (para 92).
Regarding claim 13, the method of claim 12, wherein the plot comprises a two dimensional or three-dimensional density plot of the plurality of cell subpopulations (fig. 8-10).
Regarding claim 14, the method of claim 12, wherein the morphology dataset comprises a plurality of morphological parameter measurements of a plurality of cells of the blood sample (para 41).
Regarding claim 15, the method of claim 1, further comprising identifying an infection of the individual based at least in part on the activation state associated with the blood sample (para 44).
Regarding claim 16, the method of claim 1, further comprising providing laser light to illuminate the cell (para 56).
Regarding claim 17, the method of claim 16, wherein the change in voltage is based at least in part on scattering of the laser light from illumination of the cell (para 41, 87-88).
Regarding claim 18, the method of claim 17, wherein the scattering of the laser light is detected by the detector para 56).
Regarding claim 19, the method of claim 1, further comprising hydrodynamically focusing a plurality of cells comprising the cell prior to the region of the flow channel (para 43).
Regarding claim 20, the method of claim 1, wherein the plurality of subpopulations of the blood sample comprises resting leukocytes and activated leukocytes (para 44).
Regarding claim 21, the method of claim 1, wherein the detector comprises a plurality of photodetectors (para 10, 42 ,48).
Regarding claim 22, the method of claim 15, wherein the infection is a blood stream infection (para 44).
Response to Arguments
Applicant’s arguments with respect to claims 1-5, 8 and 10-22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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, Tuesday, Thursday, Friday, 8-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758