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 .
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 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.
Claim(s) 1-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shao (US 2022/0236281).
Regarding claim 1, Shao teaches a method and system for identifying a target comprising collecting the microparticles (cells) on the membrane (membrane filter); recording the microparticles by at least one recording (fluorescent reading) of the membrane (membrane filter); and recording at least one reference marker per recording. (refer to paragraph [0181])
Regarding claim 2, recording at least two of the reference markers (P, C and N) per recording, with the two reference markers being located on opposite sides of the recording. (refer to paragraph [0181])
Regarding claim 3, at least one of the reference markers (P, C and N) is always detectable between two of the recordings. (refer to paragraph [0181])
Regarding claim 4, recording at least two different imaging distances per recording segment on the membrane (membrane filter) and generating the at least two different imaging distances per said recording segment into one of the recordings. (refer to paragraph [0181])
Regarding claim 5, the recording contains at least one fluorescence recording. (paragraph [0031])
Regarding claim 6, carrying out the method in a fluidic channel system. (refer to paragraph [0033])
Regarding claim 7, collecting the microparticles (cells) on the membrane (membrane filter); recording the microparticles by at least one recording (fluorescent reading) along the membrane (membrane filter); and carrying out at least one processing step on the membrane (membrane filter before the recording (fluorescent reading). Shao teaches in paragraph [0033], “The cells were also counterstained with nuclear dye Hoechst 33342. (a) Fixed cells were permeabilized with 0.1% Triton X-100 before immunostaining. (b) Live cells were permeabilized in 0.1% saponin for immunostaining.”
Regarding claim 8, the at least one processing step comprises at least one of a fixation, conditioning, coloring of the microparticles (1), a background reduction, a thermal excitation, or an optical excitation. (refer to paragraph [0033])
Regarding claim 9, rinsing the collected microparticles (cells) in a small volume into a chamber (chamber) connected to the detection area (filter); treating the small volume of the microparticles with at least one substance held in the chamber (chamber); and rinsing (washing) the microparticles (cells) back into the detection area (filter) for the recording (fluorescent reading). Shao teaches in paragraph {0136], “Cell suspensions were prepared and labeled with 5 μg/ml primary antibodies for 1 h at 4° C., as previously described. Following centrifugation and washing, cells were labeled with 2 μg/ml FITC-conjugated secondary antibody (Becton Dickinson) for 30 min at 4° C. and washed twice by centrifugation. FITC fluorescence was assessed using a LSRII flow cytometer (Becton Dickinson). Mean fluorescence intensity of all cells, excluding debris, was determined using FlowJo (version 10.4.2), and biomarker expression levels were normalized against isotype control antibodies.”
Regarding claim 10, using a reference element (STAMP) to focus a recording unit (fluorescence reader) for making the recording and the reference element (STAMP) is arranged outside the detection area.
Regarding claim 11, the detection area comprising a receiving chamber (chamber) with a membrane (membrane filter) and at least one reference marker, and the membrane (membrane filter) is pretensioned (embedded by two PDMS layers) in the receiving chamber (chamber). [0151]
Regarding claim 12, the membrane (membrane filter) is pretensioned by a clamping ring or a clamping means (PDMS layers), and the clamping ring (11) or the clamping means is at least one of incorporated into a receptacle or is sealing. (refer to figure 3)
Regarding claim 13, a material of the receiving chamber (chamber) at least partially penetrates the membrane (membrane filter). [0151]
Regarding claim 14, the receiving chamber (chamber) and the membrane (membrane filter) have different optical properties. [0171]
Regarding claim 15, the membrane (membrane filter) has an outlet. (figure 4)
Regarding claim 16, the outlet (figure 4) of the membrane (membrane filter) is vented by valve in figure 3.
Regarding claim 17, the membrane (membrane filter) is elongated. (figure 3)
Regarding claim 18, the receiving chamber (chamber) has an inlet and an outlet, and the membrane (membrane filter) is positioned between the inlet and the outlet. (figure 4)
Regarding claim 19, the at least one reference marker is formed on the membrane (membrane filter). [0181]
Regarding claim 20, the at least one reference marker or at least two of the reference markers are aligned on the membrane or towards the membrane such that at least two positions of the at least one reference marker or of the at least two reference markers are adapted to be recorded for each recording. Shao teaches in paragraph [0181], “To determine the subcellular distribution of individual markers of interest (M.sub.1-M.sub.n), in each experiment and analysis, we include three position markers as intrinsic spatial references, for plasma membrane (P), cytoplasm (C) and nucleus (N), respectively (see FIG. 16 for details). For all markers, the STAMP assay generates a signal distribution map, which comprises information of both marker abundance as well as subcellular localization. To determine the markers' relative subcellular distribution, regardless of their absolute abundance, we arrange the STAMP distribution map as a relative distribution matrix (R). For the position markers, R.sub.position is a 3×3 matrix, with ratios of the different localization signals as the matrix elements. Specifically, for each position marker, its three ratios of localization signals (i.e., L1/L2, L1/L3 and L2/L3) collectively reflect the marker's subcellular distribution. As the position markers were chosen for their established and predominant localization, we assume that these markers completely reside in one location. We thus use R.sub.position to solve for a conversion function, f(x), to reflect this protein distribution. Applying the generated conversion function, we process the STAMP signals of the markers of interest to determine their relative subcellular distribution.”
Regarding claim 21, each said reference marker or each recording segment has an individualized identification. ([0181])
Regarding claim 22, the detection area is located in a fluidic channel system, and the detection area is connected to at least one chamber. (figure 4)
Regarding claim 23, the at least one chamber comprises at least one substance. (figure 4)
Regarding claim 24, the fluidic channel system comprises a foil which is at least one of positioned opposite the membrane (membrane filter) or is removable. (figures 3 and 4)
Regarding claim 25, a disc shaped carrier detection area according to claim 11. (figures 3 and 4)
Regarding claim 26, a reference element arranged outside of the detection area. (figures 3 and 4)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JYOTI NAGPAUL whose telephone number is (571)272-1273. The examiner can normally be reached M-F 9am to 5pm, EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JYOTI Mutreja/Primary Examiner, Art Unit 1798
Prosecution Insights