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 .
Election/Restrictions
Applicant's election with traverse of the invention of Group I, claims 1-14 and 21-24, in the reply filed on 08/20/2025 is acknowledged. The traversal is on the ground(s) that the groups share unity of invention (remarks, page 2). This argument is not found persuasive because, as mentioned in the previous Office action, all of the claimed inventions are drawn to methods. 37 CFR 1.475(b) states that an international or national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories: (1) a product and a process specially adapted for the manufacture of said product; (2) a product and a process of use of said product; (3) a product, a process specially adapted for the manufacture of the said product, and a use of the said product; (4) a process and an apparatus or means specifically designed for carrying out the said process; or (5) a product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process. The instant claims include four independent claims reciting methods of use, and so the instant claims do not fall within any of the groups of inventions that may have unity of invention. 37 CFR 1.475(d) states that, if multiple processes of use are claimed, the first invention of the category first mentioned in the claims of the application and the first recited invention of each of the other categories related thereto will be considered as the main invention in the claims. As such, 37 CFR 1.475 makes no provision for unity of invention among different methods of use. Accordingly, Applicant’s arguments that the instant claims share unity of invention are not found persuasive.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
The amendment of 08/20/2025 has been entered. Claims 1-27 are pending in this US patent application. Claims 15-20 and 25-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/20/2025.
Claims 1-14 and 21-24 are currently under examination and were examined on their merits.
Information Disclosure Statement
The information disclosure statement filed in this application on 12/08/2022 has been received and considered.
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 and 13 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 3 and 13, the phrases "preferably" (claim 3) and “such as” (claim 13) render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). As such, one of ordinary skill in the art would be unable to determine the metes and bounds of claims 3 and 13, rendering them indefinite. Therefore, claims 3 and 13 are rejected under 35 U.S.C. 112(b).
In the interest of compact prosecution, the Examiner has interpreted claims 3 and 13 without the limitations that follow the words “preferably” (claim 3) or “such as” (claim 13).
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 1-7 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qiao et al., IEEE Transactions on Biomedical Engineering 59(8): 2321-2329 (2012; cited on the IDS filed 12/08/2022).
Qiao teaches the measurement of the impedance of cell suspensions (see entire document, including page 2322, left column, paragraph 2). The three cell lines investigated were invasive human breast cancer cell line MDA-MB-231, early-stage human breast cancer cell line MCF-7, and human breast tissue cell line MCF-10A (page 2322, left column, paragraph 3; reads on claims 3-5 and 21). The impedance measurements for each cell line were conducted five times (page 2323, left column, paragraph 1; reads on claim 2). The averaged impedance measured for each cell line was plotted (page 2324, right column, Figure 6), as were the conductivities for each cell line (page 2325, left column, Figure 7), allowing for the determination of key electrical parameters that can identify the three types of breast cell lines (page 2325, right column, paragraph 2; page 2326, Tables III and IV; reads on claims 1-2; the Examiner notes that the extensive graphing and calculation of the results, some of which apply to malignant neoplastic cells, can be interpreted as “comparing” the electrical activities and “subsequently assigning a score for the metastatic and/or invasive potential of the malignant neoplasm by ranking the recorded electrical activity of the one or more reference sample” as recited in claim 1, given that the types of comparing and ranking or of the assigned “score” are not limited in the instant claims; the Examiner further notes that the measurement of impedance as shown in Figure 6 involves the measurement of resistance, as plotted on the X axis of Figure 6, and is equivalent to voltage over current, and so the plot shown in Figure 6 incorporates the limitations of claims 6-7).
Therefore, claims 1-7 and 21 are anticipated by Qiao and are rejected under 35 U.S.C. 102(a)(1).
Claim Rejections - 35 USC § 103
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, 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 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 1-12 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Qiao et al., IEEE Transactions on Biomedical Engineering 59(8): 2321-2329 (2012; cited on the IDS filed 12/08/2022), in view of Rocha et al., Sci. Rep. 6: 34843 (2016; cited on the IDS filed 12/08/2022).
As discussed above, claims 1-7 and 21 are anticipated by Qiao. However, this reference does not teach the particular measurement apparatus recited in instant claims 8-12 and 22-24.
Rocha teaches measuring the extracellular activity of electrogenic malignant cells using a microelectrode array (see entire document, including page 1, paragraph 2). Reducing the impedance of the electrode optimizes the signal-to-noise ratio, allowing for the measurement of current and voltage in cells that do not exhibit action potentials (page 2, paragraphs 3-4). The electrodes, which were coated in gold, had areas of 2 mm2, and the cells were allowed to adhere to the electrodes for two hours prior to measurement (page 2, paragraphs 5-9; cf. claims 8-12 and 23-24). Signals at low frequency, below 10 Hz, were measured (page 2, paragraph 8; cf. claim 22).
While Qiao does not teach the use of the microelectrode array of Rocha in measuring the electrical activity of various breast and breast cancer cell lines, it would have been obvious to one of ordinary skill in the art to do so because Rocha teaches that their microelectrode array can measure electrical activity in malignant cells and that it optimizes the signal-to-noise ratio and allows for the detection of signals at low frequencies. One of ordinary skill in the art would have a reasonable expectation that using the measurement device of Rocha in the method of Qiao would successfully result in the measurement of the electrical activities of the cells of Qiao.
Therefore, claims 1-12 and 21-24 are rendered obvious by Qiao in view of Rocha and are rejected under 35 U.S.C. 103.
Claims 1-7, 13-14, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Qiao et al., IEEE Transactions on Biomedical Engineering 59(8): 2321-2329 (2012; cited on the IDS filed 12/08/2022), in view of Roger et al., Biochim. Biophys. Acta 1616: 107-111 (2003; cited on the IDS filed 12/08/2022).
As discussed above, claims 1-7 and 21 are anticipated by Qiao. However, Qiao does not teach performing the measurements in the presence of a voltage gated sodium channel-inhibiting agent as recited in instant claims 13-14.
Roger examines the effect of sodium currents on the invasion capacity of breast cancer cell lines MDA-MB-231 and MCF-7 (see entire document, including page107, left column, paragraph 2). The invasive cell line MDA-MB-231 exhibits a fast inward sodium current that is blocked by tetrodotoxin (page 109, Figures 1 and 2; cf. claims 13-14; the Examiner notes that all measurements taken in the presence of TTX must intrinsically have occurred after the addition of TTX as recited in instant claim 14), but this current was not observed in MCF-7 cells (page 109, left column, paragraph 1).
While Qiao does not teach performing the measurements of the electrical activity of MCF-7 and MDA-MB-231 cells in the presence of a voltage gated sodium channel-inhibiting agent, it would have been obvious to one of ordinary skill in the art to do so because Qiao teaches that their measurement method allows for the differentiation between different breast and breast cancer cell lines, and Roger teaches a particular electrical current from a sodium channel that is specific to MDA-MB-231 and blocked by tetrodotoxin, which is a voltage gated sodium channel-inhibiting agent. One of ordinary skill in the art would have a reasonable expectation that performing the measurements of Qiao in the presence of the TTX of Roger would successfully provide more information regarding the electrical activity of the cell lines of Qiao to allow for better differentiation between the cell lines.
Therefore, claims 1-7, 13-14, and 21 are rendered obvious by Qiao in view of Roger and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau, can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 12/22/2025