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 .
Claims 2-7, 11, 12, and 15 are being prosecuted. Claims 8-10, 20-22, 24, 25, 27, and 29-31 are withdrawn. Claims 1, 13, 14, 16-19, 23, 26, and 28 are cancelled.
Claim Rejections - 35 USC § 101
2. 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.
3. Claims 2-7, 11, 12, and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature/natural phenomena without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to § 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
Claim 2 recites a method of determining any one of: invasiveness, metastatic potential, infiltration, and differentiation state of a cell population according to indentation activity. These cell properties are all considered indicators of cancer cells, especially determination of metastatic potential. Thus, claim 2 is actually directed to determining the presence of cancer cells (i.e. diagnosis of cancer) by determining the aforementioned properties of a cell population by their indentation activity.
The correlation of indentation activity of the cell population to any of the aforementioned cancer related cell properties provides for a diagnosis of cancer and thus, a law of nature/natural phenomena judicial exception. Paragraphs [0006], [0011], and [0012] of the specification teach correlation of indentation activity to the aforementioned cell properties as a way to diagnose cancer.
Claim 2 is also directed to abstract idea judicial exceptions – (1) mathematical concept, and (2) mental process. Claim 2 recites plotting data from quantified indentation activity on a mechanical invasiveness plot where indentation activity data is compared relative to an invasiveness line cutoff (generated from the equation y = -2x + 60) and/or a non-invasive/benign box cutoff. The plot is a mathematical concept because it represents a mathematical relationship between indentation activity data points relative to the invasiveness line cutoff. The specification does not define how the non-invasive/benign box cutoff is determined but is claimed as part of the mechanical invasiveness plot which suggests the non-invasive/benign box cutoff is also part of a mathematical concept. With respect to a mental process, claim 2 recites making determinations of invasiveness, metastatic potential, infiltration, and differentiation state based on where indentation activity data points are plotted relative to the invasiveness line cutoff and/or a non-invasive/benign box cutoff. Correlating where indentation activity data points are plotted to invasiveness, metastatic potential, infiltration, and differentiation state of a cell population is considered a mental process.
Claim 7 recites an additional comparison step where indentation activity on a second gel having a different stiffness is compared to the first gel. Such a comparison is also considered a mental process.
Step 2A, Prong 2
Claims 2-7, 11, 12, and 15 fail to recite any additional elements beyond the judicial exceptions that integrate the judicial exceptions into a practical application of the exceptions. Independent claim 2 recites the actual method steps for determination of indentation activity of the cell population but claims 2-7, 11, 12, and 15 fail to recite any additional steps that integrate the judicial exceptions into a practical application of the exception or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claims are more than a drafting effort designed to monopolize the exception.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
The additional steps and elements of claims 2-7, 11, 12, and 15 do not add significantly more to the judicial exception. Kristal-Muscal et al (“Mechanical interaction of metastatic cancer cells with a soft gel”, Procedia IUTAM 12 (2015), 211-219) disclose a method for measuring indentation activity of metastatic cells on a soft gel. The gel can be produced in the range of 100 Pa to 100 kPa (Young’s modulus) and contain fluorescent particles on its surface. Forces, including normal forces (i.e. indentation activity) applied to the gel by the cells are measured by traction force microscopy. Gel deformation is obtained by imaging a small volume of the gel with embedded fluorescent particles marking its location. 2 images (with and without cells) are correlated to provide 3 dimensional deformation on the gel due to forces applied by the cells (page 215). Kristal-Muscal et al monitored the indentation produced by a metastatic breast-cancer cell on soft, flat, polyacrylamide gels with 200-nm fluorescent particles marking the gel surface. The fluorescent particles are within the gel and unreachable to the cells. Gels with Young’s moduli of 1,250+/-150 Pa and 2,300+/-200 Pa, representing physiologically soft tissue were used. As a metastatic cell indents the substrate, 3D structural changes are revealed through focal-height changes in the particles embedded at the gel surface. That depth-of-indentation allows evaluation of the applied normal force using the Hertz model. Comparison forces applied by high low metastatic potential (MP) breast cancer cells and benign breast cells as control®; cells are MDA-MB-231, MDA-MB-468, and MCF-10A, respectively. While the metastatic cells indented the gels, control benign cells remained rounded and did not indent gels at any timescale (page 216).
Kristal-Muscal et al teach the method of classifying a cell population according to indentation activity recited in claim 2.
The claimed limitations as currently presented fail to recite limitations that add a feature that is more than well understood, conventional or routine in the field of measuring indentation activity.
For all of these reasons, the claims fail to include additional elements that are sufficient to either integrate the judicial exception(s) into practical application(s) thereof, or amount to significantly more than the judicial exception(s).
Claim Rejections - 35 USC § 112
4. 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.
5. Claims 2-7, 11, 12, and 15 are 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.
The specification, as originally filed, does not provide support for a mechanical invasiveness plot as now recited in claim 2. Paragraphs [0122] and [0123] discloses diagnosis/prognosis plots which contain the invasiveness line cutoff and non-invasiveness/benign box cutoff recited in claim 2 but not a mechanic invasiveness plot containing the invasiveness line cutoff and non-invasiveness/benign box cutoff.
This is a new matter rejection. Applicants are encouraged to point to specific parts of the instant specification that provide support for the mechanical invasiveness plot that is now recited in claim 2 or cancel this limitation.
6. 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.
7. Claims 2-7, 11, 12, and 15 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.
Claim 2 is vague. In part (b), the recitation of “percentage of intending cells” is confusing because support for this limitation appears to be in paragraph [0028] of the specification but paragraph [0028] refers to “percentage of indenting cells”. In line 17, the recitation of “non-invasive/benign box cutoff of said mechanical invasiveness plot” is vague because the specification does not appear to define how this value is calculated. Moreover, the specification (paragraph [0123]) refers to the non-invasiveness/benign box cutoff” is in a diagnosis/prognosis plot and not in a “mechanical invasiveness plot” as recited in claim 2 so it is not clear what this cutoff is.
Claim Rejections - 35 USC § 102
8. Claim(s) 2-6, 11, 12, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kristal-Muscal et al (“Mechanical interaction of metastatic cancer cells with a soft gel”, Procedia IUTAM 12 (2015), 211-219) is withdrawn in view of Applicant’s amendments.
Conclusion
9. 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.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L CHIN whose telephone number is (571)272-0815. The examiner can normally be reached Monday - Friday, 10:00am - 6:30pm.
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, Bao-Thuy Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
3/19/2026