Prosecution Insights
Last updated: October 02, 2026
Application No. 18/816,334

FAIL-SAFE DRUG INFUSION THERAPY SYSTEM

Non-Final OA §102§112
Filed
Aug 27, 2024
Priority
Sep 20, 2013 — provisional 61/880,656 +3 more
Examiner
FLICK, JASON E
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Icu Medical Inc.
OA Round
1 (Non-Final)
81%
Grant Probability
Favorable
1-2
OA Rounds
11m
Est. Remaining
94%
With Interview

Examiner Intelligence

Grants 81% — above average
81%
Career Allowance Rate
763 granted / 947 resolved
+10.6% vs TC avg
Moderate +13% lift
Without
With
+13.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
34 currently pending
Career history
969
Total Applications
across all art units

Statute-Specific Performance

§101
1.5%
-38.5% vs TC avg
§103
37.0%
-3.0% vs TC avg
§102
30.4%
-9.6% vs TC avg
§112
20.4%
-19.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 947 resolved cases

Office Action

§102 §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 . Information Disclosure Statement The information disclosure statement (IDS), submitted on 11/13/2024, has been considered by the examiner. Claim Rejections - 35 USC § 112 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. Claims 21-27 and 30-33 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. [Claim 21] The claim recites the limitation of “a plurality of hardware processors” in the 2nd line of the claim. The originally filed specification does not support this limitation. At most, a first processor and a second processor are disclosed. The limitation of “a plurality of hardware processors” in the claim broadens what is recited in the originally filed specification to allow for more than two processors. As such, the limitation is considered new matter. [Claims 23 and 30] The claims recite the limitation of “command the second hardware processor to restart” in the 4th lines of the claims. The originally filed specification does not support the limitation of “restart.” At most, the specification utilizes the term “reboot,” which can be interpreted as a different command from “restart.” As such, the limitation of “restart” is considered new matter. [Claims 22-27 and 31-33] The claims are rejected based upon their dependency from independent claim 21 and dependent claim 30. 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 21-34 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 21 and 28] The claims recite the limitations of processors which are “located in a same hardware architecture” in the 2nd and 5th lines of the claims, respectively. The examiner is unable to determine the metes and bounds of the claims, since it is unclear how the phrase is intended to be interpreted. As worded, it is unclear if the processors must be located within one physical structure, or merely just have a form of communication with one another. For purposes of examination, it is interpreted that the processors need only be in communication with one another. [Claims 22-27 and 29-34] The claims are rejected based upon their dependency from independent claims 21 and 28. 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. Claims 21, 22, 28, and 29, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spencer et al. (PGPub 2010/0094221). [Claims 21 and 28] Spencer teaches a system and method of operating an infusion pump system (figure 1), comprising: controlling a motor (figure 2, item 30) of an infusion pump (figure 1, item 10) with a first hardware processor (figure 2, item 114) (figure 2; paragraph [0005]); controlling a user interface (figure 2, item 24) of the infusion pump (figure 1, item 10) with a second hardware processor (figure 2, item 118) (figure 2; paragraph [0073]), wherein the first hardware processor (figure 2, item 114) and the second hardware processor (figure 2, item 118) are located in a same hardware architecture (figure 2) of the infusion pump (figure 1, item 10) (figure 2; see 112b interpretation above); and applying, with the second hardware processor (figure 2, item 118), a fail-safe therapy and controlling operation of the motor (figure 2, item 30) during a failure of the first hardware processor (figure 2, item 114) (figure 2; paragraphs [0009], [0012], [0013], [0054], [0059], [0065], [0066]). [Claims 22 and 29] Lebel teaches the limitations of claims 21 and 28, upon which claims 22 and 29 depend. In addition, Lebel discloses the first hardware processor (figure 2, item 114) is configured to transmit a status (“beacon” signals) signal over predetermined time periods (paragraph [0045]) and wherein the second hardware processor (figure 2, item 118) is further configured to detect the failure of the first hardware processor (figure 2, item 114) based on receipt of the status signals (paragraphs [0045], [0050]). Allowable Subject Matter Claim 34 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time. 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, Bhisma Mehta can be reached at 571-272-3383. 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. /JASON E FLICK/Primary Examiner, Art Unit 3783 08/16/2026
Read full office action

Prosecution Timeline

Aug 27, 2024
Application Filed
Aug 19, 2026
Non-Final Rejection mailed — §102, §112 (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
81%
Grant Probability
94%
With Interview (+13.4%)
3y 0m (~11m remaining)
Median Time to Grant
Low
PTA Risk
Based on 947 resolved cases by this examiner. Grant probability derived from career allowance rate.

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