Prosecution Insights
Last updated: October 01, 2026
Application No. 19/293,867

FORM FITTING TERMINALLY STERILIZABLE PACKAGING SYSTEMS FOR CATHETERS

Non-Final OA §102§103
Filed
Aug 07, 2025
Priority
Aug 08, 2024 — provisional 63/680,749
Examiner
THOMAS, KAREEN KAY
Art Unit
3736
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Edwards Lifesciences Corporation
OA Round
1 (Non-Final)
77%
Grant Probability
Favorable
1-2
OA Rounds
1y 0m
Est. Remaining
94%
With Interview

Examiner Intelligence

Grants 77% — above average
77%
Career Allowance Rate
1040 granted / 1350 resolved
+7.0% vs TC avg
Strong +17% interview lift
Without
With
+17.1%
Interview Lift
resolved cases with interview
Typical timeline
2y 2m
Avg Prosecution
25 currently pending
Career history
1373
Total Applications
across all art units

Statute-Specific Performance

§101
0.8%
-39.2% vs TC avg
§103
39.2%
-0.8% vs TC avg
§102
32.9%
-7.1% vs TC avg
§112
23.6%
-16.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1350 resolved cases

Office Action

§102 §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 . 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, 7 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hirschmann et al (Hirschmann) (US9,333,289). 1. Hirschmann teaches a form-fitting packaging container (Fig. 3 at 10) for a catheter (where the container can hold a catheter), the form-fitting packaging container comprising: a hollow body (within the container 10) extending longitudinally from a first end (Fig. 3 at 204) to a second end (Fig. 3 at 202); and a plurality of supports (in the below annotated Fig. 3) disposed in the hollow body and spaced longitudinally between the first end and the second end, the plurality of supports defining a central opening (Fig. 3 at 254 and the other openings on the plurality of supports) configured to receive the catheter (where the opening is configured as such). 7. Hirschmann a form-fitting packaging container (Fig. 3 at 10) for a catheter (where the container can hold a catheter), the form-fitting packaging container comprising: a hollow body (Fig. 3 at 10) extending longitudinally from a first end (Fig. 3 at 204) to a second end (Fig. 3 at 202); and a plurality of supports (in the below annotated Fig. 3) disposed in the hollow body (Fig. 3) and spaced longitudinally between the first end and the second end, each of the plurality of supports extending inward from the hollow body to a central opening (Fig. 3 at 254 and the other openings on the plurality of supports) sized to receive the catheter (where the openings are sized to receive a catheter). 13. Hirschmann teaches a form-fitting packaging container (Fig. 3 at 10) for a catheter (where the container can hold a catheter), the form-fitting packaging container comprising: a solid wall tube (Fig. 3 at 10) extending longitudinally from a first end (Fig. 3 at 204) to a second end (Fig. 3 at 202); and a plurality of supports (in the below annotated Fig. 3) disposed in the solid wall tube and spaced longitudinally between the first end and the second end, each of the plurality of supports extending inward from the solid wall tube to a central opening (Fig. 3 at 254 and the other openings on the plurality of supports) sized to receive the catheter (where the openings are sized to receive a catheter). Claim Rejections - 35 USC § 103 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. Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirschmann, in view of Heaston (US5,037,436). 2. Hirschmann DIFFERS in that it does not disclose each of the plurality of supports comprises an inflatable bladder. Attention, however is directed to Heaston (Fig. 2 at 16), which discloses a support can comprise of an inflatable bladder. Therefore, it would have been obvious, to one of ordinary skill within the art, at the time the invention was made, to modify Hirschmann, in view of Heaston, by employing the support to be inflatable, in order to have a holder that can accommodate variable size contents. Allowable Subject Matter Claims 3-6, 8-12 and 14-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. PNG media_image1.png 776 704 media_image1.png Greyscale Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREEN KAY THOMAS whose telephone number is (571)270-5611. The examiner can normally be reached 9:00am-5:00pm. 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, Orlando E. Aviles can be reached at 571-270-5531. 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. /KAREEN K THOMAS/Primary Examiner, Art Unit 3736
Read full office action

Prosecution Timeline

Aug 07, 2025
Application Filed
Aug 10, 2026
Non-Final Rejection mailed — §102, §103 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12722351
POLYESTER RESIN CLOSURES FOR CONTAINERS
1y 11m to grant Granted Sep 01, 2026
Patent 12715103
Coupling Mechanism for a Utility Module
2y 0m to grant Granted Aug 25, 2026
Patent 12715644
INTERMEDIATE BULK CONTAINER (IBC) AND ASSOCIATED PALLET
1y 5m to grant Granted Aug 25, 2026
Patent 12709462
PANEL BOX ATTACHMENT FOR A FLUID STORAGE TANK
1y 10m to grant Granted Aug 18, 2026
Patent 12698153
RECEPTACLES WITH INTERIOR LINER DISPENSERS
2y 5m to grant Granted Aug 04, 2026
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
77%
Grant Probability
94%
With Interview (+17.1%)
2y 2m (~1y 0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1350 resolved cases by this examiner. Grant probability derived from career allowance rate.

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