Prosecution Insights
Last updated: April 18, 2026
Application No. 17/920,255

DETECTION OF MEDICAL CONDITION, SEVERITY, RISK, AND ACUITY USING PARAMETERS

Non-Final OA §101§103
Filed
Oct 20, 2022
Examiner
SKIBINSKY, ANNA
Art Unit
1635
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
BECKMAN COULTER, INC.
OA Round
1 (Non-Final)
39%
Grant Probability
At Risk
1-2
OA Rounds
4y 5m
To Grant
68%
With Interview

Examiner Intelligence

Grants only 39% of cases
39%
Career Allow Rate
263 granted / 677 resolved
-21.2% vs TC avg
Strong +30% interview lift
Without
With
+29.5%
Interview Lift
resolved cases with interview
Typical timeline
4y 5m
Avg Prosecution
34 currently pending
Career history
711
Total Applications
across all art units

Statute-Specific Performance

§101
33.8%
-6.2% vs TC avg
§103
26.1%
-13.9% vs TC avg
§102
5.8%
-34.2% vs TC avg
§112
27.8%
-12.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 677 resolved cases

Office Action

§101 §103
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 2/2/2023 and 10/20/2022 have 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 63/013411 filed 4/21/2020 is acknowledged. Status of Claims Claims 1-20 are under examination. Claims 21-22 are cancelled. 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 1-20 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 1-20 are directed to a method, so a process. Step 2A Prong One: Identification of an Abstract Idea The claim(s) recite(s) Characterizing a WBC in a blood sample. This step reads on a mental process and is therefore an abstract idea . Calculating a MDW (monocyte distribution width) value for the blood sample; if the MWD value for the blood sample is less than or equal to 20, indicating that viral infection is unlikely; and if greater than or equal to 20. This step reads on the mathematics of calculating a numerical value which could also be performed by the human mind, and evaluating if the number is less than or greater than 20. The step is therefore an abstract idea . evaluating one or more percent lymphocytes, a standard deviation for neutrophil LALS, a WBC percent eosinophils, a monocyte index, a mean ALL for monocytes, a standard deviation for monocyte MALS, a monocyte opacity mean, a standard deviation for ALL for monocytes, a WBC percent basophils, LHD, a standard deviation for volume for WBC, a standard deviation for volume for monocytes and neutrophils, or a WBC percent neutrophils. The step of evaluating the recited metrics read s on a mental process o r math and is therefore an abstract idea . Step 2A Prong Two : Consideration of Practical Application The claims result in an evaluation step which is an abstract idea. 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. characterizing a WBC in a blood sample comprises impedance and light scattering measurements. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because performing impedance and light scattering measurements on blood samples is routine, conventional and well understood. 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). Claim s 1 and 6-19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Crouser et al. (Critical Care Medicine, vol. 47 (2018) pgs. 1018-1025; IDS 10/20/20). Crouser et al. detection of Sepsis by measuring WBC count (Abstract)(i.e. characterizing a WBC count in a blood sample), as in claims 1 and 16. Crouser et al. teach measuring monocyte distribution width (MDW) as an additional marker for sepsis (Abstract)(i.e. calculating MDW value for the blood sample). Crouser et al. teach that the threshold for MDW is 20.5 (Abstract) and that MDW was considered to be normal if less than 20 (page 520, col. 2, par. 1)(i.e. if the MDW value is less than or equal to 20, indicating that the viral infection is unlikely) , as in claim 1 and 16. Crouser et al. teach WCB and MDW as biomarkers for sepsis wherein there is a 14% chance that the sepsis is caused by a viral infection (page 521, col. 1, par. 1), as in claims 1, 15, 16 and 19. Crouser et al. do not specifically teach applying the parameter of “20” as an indicator that a viral infection is likely or unlikely. Crouser et al. do not specifically teach evaluating a likelihood that the blood sample is from an individual with a viral infection. However Crouser et al. teach that causes of sepsis are 14% viral (page 521, col. 1, par. 1) and that monocytes are first responders to infections including to viral pathogens (page 522, col. 2). I t would therefore be obvious to one of ordinary skill in the art to have combined the teachings of Crouser et al. for assessing WBC and MDW in a blood sample to determine sepsis as applied to sepsis caused by viral infections. Crouser et al. provide motivation by teaching that monocytes are first responders to infections including to viral pathogens (page 522, col. 2). One of ordinary skill would have an expectation of success at using the WBC an MDW parameters to determine a chance of viral infections because these parameters are used for sepsis, of which 14% are due to viral infection. Crouser et al. teach laboratory test available to clinicians if infection is suspected (page 519, col. 2, par. 1)(i.e. test order), as in claim 6. Crouse r et al. teach CBC testing (Abstract) measuring routine CBC count parameters (page 521, col. 1, par. 1), wherein CBC-DIFF testing is well known to those of ordinary skill in the art, as in claims 7 and 11. Crouser et al. teach neutrophil percentage (page 521, col. 1, par. 2), as in claim 8. Crouser et al. teach using the UniCel DxH 800 analyzer which is known to measure blood cell counts by combining electrical impedance and light scatter (page 519, col. 1, par. 2) and suggests not relying on cytochemical stains or affinity based markers , as in claim s 9 -10 . Crouser et al. teach measuring mean neutrophil volume (MNV) (page 519, col. 1, par. 2) which suggests measuring neutrophil low angle light scatter (LALS) which is known to those of ordinary skill as a measure of neutrophil size. Crouser et al. teach that measuring increase in volume of circulating neutrophils would improve sepsis detection (page 519, col. 1, par. 2), as in claim 12. Crouser et al. teach considering MDW to be normal if less than 20 (page 520, col. 2, par. 1) which reads on being a decision rule, as in claim s 13 and 17. Crouser et al. teach adding MDW + WDC (Abstract, results)(i.e. linear combination of parameters), as in claim s 14 and 18. Clai ms 5 and 20 are rejected under 35 U.S.C. 103(a) as being unpatentable over Crouser et al. as applied to claim s 1 and 6-19 above, and further in view of Frater et al. (International Journal of Laboratory Hematology, vol. 42 (2020) pgs. 11-188; IDS filed 10/20/2022) . Crouser et al. teach claims 1 and 6-19. Crouser et al. do not teach that the viral infection is SARS-CoV-2, as in claim s 5 and 20 . Frater et al. teach biomarkers for inflammation include MDW (page 13, col. 2, section 3.4 Markers of systemic inflammation) . Frater et al. teach that MDW is increased in COVID-19 patients (page 13, col. 2, par. 3), as in claim s 5 and 20 . It would therefore be obvious to one of ordinary skill in the art to have combined the teachings of Crouser et al. for assessing WBC and MDW in a blood sample to determine sepsis as applied to sepsis caused by viral infections with the teaching of Frater et al. for using MDW as a biomarker for COVID-19. Frater et al. provide motivation by teaching that MDW is increased in COVID-19 patients and would therefore be an effective biomarker. One of ordinary skill would have an expectation of success at combining the teachings of Crouser et al. and Frater et al. because both teach blood biomarkers including monocytes as biomarkers for inflammation from viral infections. 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 EF S 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. 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 system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would 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. /Anna Skibinsky/ Primary Examiner, AU 1635
Read full office action

Prosecution Timeline

Oct 20, 2022
Application Filed
Mar 31, 2026
Non-Final Rejection — §101, §103 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
39%
Grant Probability
68%
With Interview (+29.5%)
4y 5m
Median Time to Grant
Low
PTA Risk
Based on 677 resolved cases by this examiner. Grant probability derived from career allow rate.

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