Prosecution Insights
Last updated: April 19, 2026
Application No. 18/269,171

SELECTIVE LYSIS OF HUMAN BLOOD CELLS

Non-Final OA §102§103§112
Filed
Jun 22, 2023
Examiner
SALMON, KATHERINE D
Art Unit
1682
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Roche Molecular Systems, Inc.
OA Round
1 (Non-Final)
42%
Grant Probability
Moderate
1-2
OA Rounds
3y 11m
To Grant
80%
With Interview

Examiner Intelligence

Grants 42% of resolved cases
42%
Career Allow Rate
329 granted / 776 resolved
-17.6% vs TC avg
Strong +38% interview lift
Without
With
+38.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 11m
Avg Prosecution
105 currently pending
Career history
881
Total Applications
across all art units

Statute-Specific Performance

§101
18.3%
-21.7% vs TC avg
§103
27.9%
-12.1% vs TC avg
§102
13.2%
-26.8% vs TC avg
§112
33.7%
-6.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 776 resolved cases

Office Action

§102 §103 §112
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 . Claims 1-12 are pending. An action on the merits is set forth below. Claim Objections Claims 5-12 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claims cannon depend from any other multiple dependent claims. See MPEP § 608.01(n). Accordingly, the claims have not been further treated on the merits. 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 1-4 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. Claims 1-4 are indefinite over the phrase “pH of around 9.0 or slightly lower” in claim 1. This phrase is unclear as It is not clear the metes and bounds of the term “slightly lower”. The term “slightly lower” in claim 1 is a relative term which renders the claim indefinite. The term “slightly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In particular it is not clear which pH values would be encompassed by the term. Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 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. Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koninkijke Philips Electronics (EP233105 6/15/2011 cited on IDS.) With regard to claim 1, Koninkijke Philips Electronics applicant teaches providing a sample with eukaryotic cells containing a microorganism (paragraph 58). Koninkijke Philips Electronics applicant teaches a method of adding a nonionic detergent and a buffer (paragraph 59). Koninkijke Philips Electronics applicant teaches that the pH can be 9 (table 1). Koninkijke Philips Electronics applicant teaches that the ratio between the added detergent and buffer and the sample can be 2:1 and 1:10 (para 14). Koninkijke Philips Electronics applicant teaches that the solution is incubated to lyse the cells (para 58-59). With regard to claims 2-3, Koninkijke Philips Electronics applicant teaches that the non-ionic detergent is present at 1% w/v or v/v (para 47). Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 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. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim(s4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koninkijke Philips Electronics (EP233105 6/15/2011 cited on IDS.) in view of Adie et al. (US Patent Application 8192958 June 5, 2012) cited on IDS). Koninkijke Philips Electronics applicant teaches providing a sample with eukaryotic cells containing a microorganism (paragraph 58). Koninkijke Philips Electronics applicant teaches a method of adding a nonionic detergent and a buffer (paragraph 59). Koninkijke Philips Electronics applicant teaches that the pH can be 9 (table 1). Koninkijke Philips Electronics applicant teaches that the ratio between the added detergent and buffer and the sample can be 2:1 and 1:10 (para 14). Koninkijke Philips Electronics applicant teaches that the solution is incubated to lyse the cells (para 58-59). Koninkijke Philips Electronics applicant provides some examples of non-ionic detergents such as HLB, nonidet, Brij, Tween, octylgucoside and triton (para 15). However, Koninkijke Philips Electronics applicant does not teach the use of polidocanol. With regard to claim 4, Adie et al teaches a method lysing eukaryotic cells that contain bacterial, fungal, viral cells (para 8). Adie et al. teaches incubating the sample in the presence of a buffering solution and 0.5 to 5% V/V polidocanol (para 18). Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Koninkijke Philips Electronics applicant to use any functionally equivalent non-ionic detergent such as polidocanol as taught by Adie et al. It would be obvious to substitute one known non-ionic detergent for another as these detergents perform the same function in the solution of Koninkijke Philips Electronics applicant. As Adie et al. teaches that polidocanol can be used in the same method as Koninkijke Philips Electronics applicant to lyse eukaryotic cells comprise bacteria cells, the ordinary artisan would have a reasonable expectation of success of using polidocanol in the method of lysing. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530. 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, Wu Cheng (Winston) Shen can be reached at 5712723157. 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. /KATHERINE D SALMON/ Primary Examiner, Art Unit 1682
Read full office action

Prosecution Timeline

Jun 22, 2023
Application Filed
Nov 16, 2025
Non-Final Rejection — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
42%
Grant Probability
80%
With Interview (+38.0%)
3y 11m
Median Time to Grant
Low
PTA Risk
Based on 776 resolved cases by this examiner. Grant probability derived from career allow rate.

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