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 .
Information Disclosure Statement
The IDS filed 10/31/2024 has been considered by the Examiner.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Priority of US application 63/340511 filed 5/11/2022 is acknowledged.
Claim Election/Restriction
Election without Traverse
Applicant’s election without traverse of claims 15-20 in the reply filed on 9/30/2025 is acknowledged.
Claims 1-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/30/2025.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 15-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Step 1: Process, Machine, Manufacture or Composition
Claims 15-20 are drawn to a method, so a process.
Step 2A Prong One: Identification of an Abstract Idea
The claim(s) recite(s)
1. identifying a trend in the plurality of capacitance measurements.
This step can be performed by the human mind by looking at numerical values of capacitance measurement. The step is therefore an abstract idea.
2. identifying a conjugate trend in the plurality of capacitance measurements.
This step can be performed by the human mind by analyzing capacitance measurements and recognizing related trends. The step is therefore an abstract idea.
3. calculating a degree of symmetry between the trend and the conjugate trend.
This step can be performed by the human mind by analyzing whether there are commonalities in capacitance measurements. The step is therefore an abstract idea.
4. associating a cellular event with the degree of symmetry.
This step can be performed by the human mind by recognizing a correlation between capacitance measurements and known cell behavior. The step is therefore an abstract idea.
Claims 16-20 are drawn to further steps of data analysis and manipulation and are therefore also abstract ideas.
Step 2A Prong Two: Consideration of Practical Application
The claimed method results in a step of associating information which is a cellular event with an analyzed degree of symmetry. The claims do not recite any additional elements that integrate the abstract idea into a practical application.
This judicial exception is not integrated into a practical application because the claims do not meet any of the following criteria:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than
a drafting effort designed to monopolize the exception.
Step 2B: Consideration of Additional Elements and Significantly More
The claimed method also recites "additional elements" that are not limitations drawn to an abstract idea. The recited additional elements are drawn to:
1. obtaining a plurality of capacitance measurements over a period of time from a sensor in contact with a cell.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because capacitance measurements of biological cells are well known, routine and conventional.
Viewed as a whole, these additional claim element(s) do not provide meaningful limitation(s) to transform the abstract idea recited in the instantly presented claims into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself. Therefore, the claim(s) are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 15-20 are rejected under 35 U.S.C. 103(a) as being unpatentable over Senevirathna et al. (IEEE transactions on biomedical circuits and systems, vol. 12 (2018) pgs. 510-520)
Senevirathna et al. teach tracking the migration of cells on a capacitance sensor array (Abstract).
Senevirathna et al. teach time series measurements of capacitance from cells that move on a sensor array (Figure 5a)(i.e. obtaining a plurality of capacitance measurements over a period of time from a sensor in contact with a cell), as in claim 15.
Senevirathna et al. teach (pages 516-517, connecting par.) that as cells adhere and proliferate, they can also move from one location to another, a phenomenon called cell migration; Senevirathna teach that in Fig. 5(a) increase in absolute sensed capacitance results from cell proliferation and covering more electrode area while cells migrating away from an electrode, they cover less electrode area, causing a corresponding decrease in signal (i.e. identifying a trend in the plurality of capacitance measurements), as in claim 15.
Senevirathna et al. teach (page 517, col. 1, par. 1) that several sensor channels show signal fluctuations over a period of several hours as reflected in Figure 5a (i.e. identifying conjugate trend in the plurality of capacitance measurements), as in claim 15.
Senevirathna et al. teach (page 517, col. 1, par. 1) that sensor (1, 4) shows a gradual signal drop which is correlated in images with a decrease in the number of cells on sensor (1, 4) between these two time-point; Senevirathna teach that sensors (3, 2) and (4, 4) also exhibit this behavior, with decreases in capacitance, respectively (i.e. symmetry between the trend and the conjugate trend), as in claim 15.
Senevirathna et al. teach (page 517, col. 1, par. 1) that these changes can be caused by cell migration to and away from the electrodes (i.e. associating a cellular event with the degree of symmetry).
Claim 15 recites that symmetry between conjugate trends is calculated. Senevirathna et al. teach observing time series capacitance data over multiple sensors and determining that increase in capacitance indicates the movement of or proliferation (i.e. growth) of cells on the sensor and decrease in capacitance indicates movement of cells away from the sensor. Senevirathna et al. do not specifically teach “calculating” a symmetry between the time series data. However Senevirathna do teach calculating growth rate and the number of effected sensors with increased capacitance over time (Table 1 and page 516, col. 2, par. 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have combined the method of Senevirathna et al. for tracking trends in capacitance time series data to determine increased cell presence in the location of the sensor indicating migration and/or proliferation with the teaching of Senevirathna et al. for calculating a growth rate from slopes. It would be obvious to one of ordinary skill to calculate the slopes of the time series data to determine when cells migrated to or proliferated on a sensor. Senevirathna et al. provide motivation by teaching the slopes result in a calculation of rate (page 516, col. 2, par. 2) which would result in numerical values that can be compared. One of skill in the art would have had a reasonable expectation of success at combining the time series capacitance data with the calculation of slope because Senevirathna et al. teach that the time series data changes trends by increasing and decreasing. Therefore a slope calculation would be successful.
Regarding claims 16-20
Regarding claim 16 which requires the cell to be a chimeric antigen receptor T cell, Senevirathna et al. teach C70 and A2780 cell lines which are known to show chemotherapeutic resistance but do not teach chimeric antigen receptor T cells. However chimeric antigen receptor (CAR) T cells are well known to those of ordinary will and would be obvious to substitute for the C70/A2780 cell lines to arrive at a simple substitution of one known element for another to achieve a predictable result. (CAR) T cells and C70/A2780 cells would both adhere, migrate and proliferate on a sensor array such that capacitance can be measured.
Senevirathna et al. teach migration and proliferation of cells (page 516, col. 2, par. 3) as observed by capacitance measurements, as in claim 17.
Senevirathna et al. teach (pages 516-517, connecting par and page 517, col. 1-2.) observing time series capacitance data over multiple sensors and determining that increase in capacitance indicates the movement of or proliferation (i.e. growth) of cells on the sensor and decrease in capacitance indicates movement of cells away from the sensor (i.e. identifying a rising or falling in a dataset comprising capacitance over time), as in claim 18.
Senevirathna et al. teach that correlating the fall in capacitance as indicated by time series point in sensors (1, 4), (3, 2) and (4,4) wherein one of ordinary skill would know to count the number of points to determine the time for the falling trend (i.e. identifying the number of points located on the trend that connect to corresponding points on the conjugate trend), as in claim 19.
Senevirathna et al. teach (page 515, col. 2, par. 3) that if cells do not settle and adhere to the sensor there will be little change in capacitance, as is evident for sensor (2,1)(in figure 5a. It would be obvious to remove time series data where cells do not adhere to the sensor because no cell induced capacitance changes are measured (i.e. removing the trend and conjugate trend in a large time gap exists between the trend and conjugate trend), as in claim 20.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Skibinsky whose telephone number is (571) 272-4373. The examiner can normally be reached on 12 pm - 8:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Ram Shukla can be reached on (571) 272-7035. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Anna Skibinsky/
Primary Examiner, AU 1635