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 .
Response to Amendment
Applicant’s amendment filed on 08/04/25 is entered. Claim 6 has been cancelled. Claims 1, 3-5, and 7 remain pending and are examined herein.
Status of Application
The rejection of claim 6 is obviated by applicant’s cancellation.
The rejection of claims 1, 3-5, and 7 under 35 U.S.C. 101 is maintained.
Claim Rejections - 35 USC § 101
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-5, and 7 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claim(s) recite(s) “preparing a calibration curve…and calculating a recovery rate for the at least one cell type” and “determining the concentration of the at least one cell type using the calibration curve and the recovery rate prepared in step(2)…wherein the calibration curve is represented by measured concentration of the at least one cell type = slope x known concentration of the at least one cell type or known concentration of the at least one cell type = slope x measured concentration of the at least one cell type”.
The limitation of step d of claim 1, as drafted, is a process that, under its broadest reasonable interpretation, covers an abstract idea in the form of mathematical concept. Nothing in the claim element precludes the step from practically being performed with existing mathematical formula or by hand. Calculating a recovery rate can have one manually calculate the difference between the measured and known value and determining a concentration based on the calibration curve and recovery rate can have one of ordinary skill in the art to manually compute the concentration of a cell type in the sample based on the reading provided by cytometer and calibration curve’s formula (Step 2A, Prong 1).
This judicial exception is not integrated into a practical application because after the determination of the unknown concentration of the sample is done, nothing is done with the information. Therefore, the scope of the claim is not practically limiting and there is no integration of conducting cytometry analysis much less a practical one after the calculation is completed (Step 2A, Prong 2)
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because acquiring data by cell cytometry with blood cell appear to be a routine and conventional ways of collecting data. Routine and conventional ways of collecting data cannot provide an inventive concept. The claim is not patent eligible.
Claims 3-5 and 7 do not cure the issue above. Claim 3 merely recites additional (generic) standard samples are used. Claims 4 and 5 recites the expected error level using the method of claim 1. Claims 6-7 recite the sample’s generic identity. None of the claims include additional elements that are sufficient to amount to significantly more than the judicial exception for the reason above.
Response to Arguments
Applicant's arguments filed 08/04/25 have been fully considered but they are not persuasive. Applicant’s argument directed the incorporation of the limitation specifying the sample is blood and at least one cell type in the sample is blood cell to be significantly more. Furthermore, applicant points to the lack of prior arts that fail to teach every limitation of the claim as evidence of unconventional and unexpected result under Step 2B (page 6-7). Examiner respectfully disagrees.
MPEP 2106.05 discloses “Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting “the Government’s invitation to substitute §§ 102, 103, and 112 inquiries for the better established inquiry under § 101”). As made clear by the courts, the “‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter.” Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9)” and “When making a determination whether the additional elements in a claim amount to significantly more than a judicial exception, the examiner should evaluate whether the elements define only well-understood, routine, conventional activity.”
Furthermore, the court points out that “Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception” may not be enough to qualify as “significantly more”. The claim recites the sample as blood is interpreted as an instance of such “high level of generality”. A claim having broad applicability across many fields of endeavor may not provide meaningful limitations that integrate a judicial exception into a practical application or amount to significantly more. On the other hand, limitations that confine the judicial exception to a particular, practical application of the judicial exception may amount to significantly more or integrate the judicial exception into a practical application.
For the following reason above, Examiner believes the rejection should be maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICKEY HUANG whose telephone number is (571)272-7690. The examiner can normally be reached M-F 9:30-5:30 PM ET.
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, Maris Kessel can be reached at 5712707698. 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.
/M.H./ Examiner, Art Unit 1758
/MARIS R KESSEL/ Supervisory Patent Examiner, Art Unit 1758