NON-FINAL REJECTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings Objection
The drawings are objected to because of the font size of fig.6 being too small. Numbers, letters, and reference characters must measure at least .32 cm. (1/8 inch) in height (see MPEP 1.84(p)).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 3-5 and 14-17 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 pre-AIA the applicant regards as the invention.
Claims 3 and 14 recite the limitation "the altered" which has not been previously defined. Thus, there is insufficient antecedent basis for this limitation in the claim.
Further, Claims 3 and 14 are rejected as being indefinite as the recited limitation "the altered" is confusing. One of ordinary skill in the art fails to ascertain the term as used in the claimed invention. Thus, one of ordinary skill in the art cannot fully determine the scope of the claimed invention.
Claims 4-5 and 15-17 are rejected as they depend on claims 3 and 14.
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 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.
Claims 1, 7-8, 12, 18 and 20-21 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Ying Zhou et al. (“Characterizing Deformability and Electrical Impedance of Cancer Cells in a Microfluidic Device,” Analytical Chemistry, vol. 90, pages 912-919, 2018, cited by the applicants, “Zhou”).
Regarding Claim 1, Zhou teaches a method for characterizing analytes in a sample fluid, the method comprising: a) passing a sample liquid containing analytes of at least a first type and analytes of a second type along a flow path through a fluid channel (e.g., "MCF-7" breast cancer cells, Figure 3, legend) and analytes of a second type ("red blood cells", Figure 3, legend) along a flow path through a fluid channel ("microfluidic channel", section "EXPERIMENTAL SECTION", subsection "Device Concept and Design", first paragraph, Figure 1); b) analysing, in a first analysing unit ("the impedance sensing electrodes", Figure 1, section "RESULTS AND DISCUSSION" subsection "Electrical Impedance Analysis", first paragraph; see also the "first pair of electrodes", section "EXPERIMENTAL SECTION", subsection "Device Concept and Design", second paragraph) including the fluid channel, the analytes of the at least first type and second type in the sample liquid, thereby obtaining first parameter values of at least one analyte characteristic associated with the analytes of the at least first type and second type (basically the "the size of the whole cell", section "RESULTS AND DISCUSSION" subsection "Electrical Impedance Analysis", first paragraph), c) storing, in a processing unit, the first parameter values of the at least one analyte characteristic (implicit for the data processing as e.g. shown in Figure 5); d) altering a further analyte characteristic associated with the analyte of the first type compared to the further analyte characteristic associated with the analyte of the second type (by passing the cells through the "constriction", section "EXPERIMENTAL SECTION", subsection "Device Concept and Design", first paragraph, Figure 1); e) analysing, in a second analysing unit (the "pair of electrodes" after the "constriction", see above) including the fluid channel, the analytes of the at least first type and second type in the sample liquid, thereby obtaining second parameter values of the at least one analyte characteristic associated with the analytes of the at least first type and second type (basically "the electrical properties of the cell", section "RESULTS AND DISCUSSION" subsection "Electrical Impedance Analysis", first paragraph); f) storing, in the processing unit, the second parameter values of the at least one analyte characteristic (likewise implicit for the data processing as e.g. shown in Figure 5); g) characterizing, in the processing unit, the analytes of the first type from the analytes of the second type by comparing the second parameter values with the first parameter values (since "By combining mechanical properties and electrical impedance information, four populations of cells (red blood cells, MCF-7, PMAmodified MCF-7, and fixed MCF-7) could be clearly distinguished from each other to the extent that is not possible by either of the two biomarkers alone", paragraph bridging left and right columns on page 913; see also section "RESULTS AND DISCUSSION" subsection "Electrical Impedance Analysis", Figure 4, and section "RESULTS AND DISCUSSION", subsection "Combining Mechanical and Electrical Measurements", Figure 5).
Regarding Claim 7, the method according to claim 1 is taught by Zhou.
Zhou further teaches, wherein the steps b) and e) comprise electrical impedance spectroscopy (EIS), in particular multi-frequency electrical impedance spectroscopy (Section 2.1.1 and “Abstract”).
Regarding Claim 8, the method according to claim 1 is taught by Zhou.
Zhou further teaches wherein step d) comprises the step of altering a membrane or causing a mechanical cell deformation of an analyte and wherein the further analyte characteristic is the electrical impedance response of the analyte (Section 2.1.1).
Regarding Claim 12, Zhou teaches a system for characterizing analytes in a sample fluid (“Abstract”; Figure 1), the system comprising at least one characterizing line (shown in Figure 1), the characterizing line comprising: a fluid channel (shown in Figure 1, microfluidic channel in “EXPERIMENTAL SECTION”) defining a flow path having an inlet and an outlet and structured to allow a sample liquid (shown in Figure 1) containing analytes of at least a first type and analytes of a second type to pass through along the flow path as well as between the inlet and the outlet seen in the direction of the flow path (e.g., "MCF-7" breast cancer cells, Figure 3, legend) and analytes of a second type ("red blood cells", Figure 3, legend) along a flow path through a fluid channel ("microfluidic channel", section "EXPERIMENTAL SECTION", subsection "Device Concept and Design", first paragraph, Figure 1), a first analysing unit ("the impedance sensing electrodes", Figure 1, section "RESULTS AND DISCUSSION" subsection "Electrical Impedance Analysis", first paragraph; see also the "first pair of electrodes", section "EXPERIMENTAL SECTION", subsection "Device Concept and Design", second paragraph) including the fluid channel and structured to analyse the analytes of the at least first type and second type in the sample liquid and structured to obtain first parameter values of at least one analyte characteristic associated with the analytes of the at least first type and second type (basically the "the size of the whole cell", section "RESULTS AND DISCUSSION" subsection "Electrical Impedance Analysis", first paragraph), an altering unit (Figure 1; "constriction") including the fluid channel downstream from the first analysing unit structured for altering a further analyte characteristic associated with the analyte of the first type compared to the further analyte characteristic associated with the analyte of the second type (by passing the cells through the "constriction", section "EXPERIMENTAL SECTION", subsection "Device Concept and Design", first paragraph, Figure 1); a second analysing unit (the "pair of electrodes" after the "constriction", see above) including the fluid channel downstream from the microfluidic device and structured to analyse the analytes of the at least first type and second type in the sample liquid and structured to obtain second parameter values of the at least one analyte characteristic associated with the analytes of the at least first type and second type (basically "the electrical properties of the cell", section "RESULTS AND DISCUSSION" subsection "Electrical Impedance Analysis", first paragraph), a processing unit (implicit in the data processing as e.g. shown in Figure 5) structured to acquire and store the first parameter values and second parameter values from the first and second analysing unit and to characterize the analytes of the first type from the analytes of the second type by comparing the second parameter values with the first parameter values (since "By combining mechanical properties and electrical impedance information, four populations of cells (red blood cells, MCF-7, PMAmodified MCF-7, and fixed MCF-7) could be clearly distinguished from each other to the extent that is not possible by either of the two biomarkers alone", paragraph bridging left and right columns on page 913; see also section "RESULTS AND DISCUSSION" subsection "Electrical Impedance Analysis", Figure 4, and section "RESULTS AND DISCUSSION", subsection "Combining Mechanical and Electrical Measurements", Figure 5).
Regarding Claim 18, the system according to claim 12 is taught by Zhou.
Zhou further teaches the system further comprising a sorting unit (“cell sorting”: page 913) including the fluid channel upstream from the first analysing unit and structured to sort the analytes of at least the first and second type on analyte size (“RESULT AND DISCUSSION”, Fig.1&3).
Regarding Claim 20, the system according to claim 12 is taught by Zhou.
Zhou further teaches wherein the first and second analysing unit comprise electrical impedance spectroscopy (EIS) means (Section 2.1.1 and “Abstract”).
Regarding Claim 21, the system according to claim 12 is taught by Zhou.
Zhou further teaches wherein the altering unit is structured for altering a membrane or causing a mechanical cell deformation of an analyte and wherein the further analyte characteristic is an electrical impedance response (Section 2.1.1).
Claim Rejections - 35 USC § 103
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 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 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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 6 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou in view of Huang et al. (US 2023/0400474 A1, “Huang”).
Regarding Claim 6, the method according to claim 1 is taught by Zhou.
Zhou does not explicitly teach wherein the step g) of characterizing of the analytes of the first type from the analytes of the second type is performed using one or more machine learning algorithms.
However, Huang teaches a method for characterizing two or more target analytes wherein the step of characterizing of the analytes of the first type from the analytes of the second type is performed using one or more machine learning algorithms [0321].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zhou art with the teaching of Huang since it is known in the art to characterize the target analyte by using machine learning algorithm [0321].
Regarding Claim 19, the system according to claim 12 is taught by Zhou.
Zhou does not explicitly teach wherein the processing unit implements one or more machine learning algorithms for characterizing the analytes of the first type from the analytes of the second type.
However, Huang teaches a system/method for characterizing two or more target analytes wherein the step of characterizing of the analytes of the first type from the analytes of the second type is performed using one or more machine learning algorithms [0321].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zhou’s system with the teaching of Huang since it is known in the art to characterize the target analyte by using machine learning algorithm [0321].
Claims 9 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou in view of Kikuchi et al. (US 2019/0070608 A1, cited by the applicants, “Kikuchi”).
Regarding Claim 9, the method according to claim 1 is taught by Zhou.
Zhou does not explicitly teach the method further comprising the step of optically sensing a sensing region of the fluid channel.
However, Kikuchi teaches a system/method comprising the step of optically sensing a sensing region of the fluid channel [0015].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zhou’s system with the teaching of Kikucha since it is known in the art to optically sense a sensing region of the fluid channel which would help precise identification of a specific cell [0014].
Regarding Claim 22, the system according to claim 12 is taught by Zhou.
Zhou does not explicitly teach the system further comprising an optic sensing unit structured to optically sense a sensing region of the fluid channel.
However, Kikuchi teaches a system/method comprising the step of optically sensing a sensing region of the fluid channel [0015].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zhou’s system with the teaching of Kikucha since it is known in the art to optically sense a sensing region of the fluid channel which would help precise identification of a specific cell [0014].
Claims 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou in view of Nowak et al. (US 2009/0186775 A1, “Nowak”).
Regarding Claim 23, Zhou teaches a platform for characterizing analytes in a sample fluid (fig.1-5), the platform comprising a plurality of systems according to claim 1 as taught by Zhou.
Zhou does not explicitly teach the system each system comprising a different characterizing line.
However, Nowak teaches devices and method for multiplex simultaneous Karyotype analyses of a single sample of genetic material using a plurality of Comparative Genomic Hybridizations with DNA based microarrays [0002] wherein the system each system comprising a different characterizing line ([0099] teaches regarding “Cell Line Characterization”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zhou’s system with the teaching of Nowak since it is known technique in the art to recognize specific cell.
Regarding Claim 24, the platform according to claim 23 is taught by Zhou in view of Nowak.
Zhou further teaches the system further comprising a sorting device (“cell sorting”: page 913) disposed upstream of the plurality of the systems and structured to sort analytes in the sample fluid to different characterizing lines of the plurality of systems (“RESULT AND DISCUSSION”, Fig.1&3).
Allowable Subject Matter
(i) Claims 3, 4, 13, 14 and Claims 5 and 15-17 that are depended on claims 4 and 14, are objected to as being dependent upon a rejected base claim, but would be allowable if –
(i) amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action; and
(ii) Claims 2 and 10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
Limitations of the respective claims are the reasons for allowability.
Conclusion
The following prior arts made of record and not relied upon, are considered pertinent to applicant's disclosure:
Newman et al. (US 2025/0172516 A1) teaches an electron paramagnetic resonant (EPR) instrument able to determine chemical properties of a sample using paramagnetic resonance [Abstract].
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUMAN NATH whose telephone number is (571)270-1443. The examiner can normally be reached on M to F 9:00 am to 5:00 pm.
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, JOHN BREENE can be reached on 571-272-4107. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SUMAN K NATH/Primary Examiner, Art Unit 2855
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