Prosecution Insights
Last updated: August 16, 2026
Application No. 19/176,059

MEDICAL DEVICE PACKAGING CONFIGURABLE FOR DEVICE PREPARATION

Non-Final OA §102
Filed
Apr 10, 2025
Priority
Oct 13, 2022 — provisional 63/379,434 +1 more
Examiner
PAL, PRINCE
Art Unit
3735
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Edwards Lifesciences Corporation
OA Round
1 (Non-Final)
70%
Grant Probability
Favorable
1-2
OA Rounds
11m
Est. Remaining
86%
With Interview

Examiner Intelligence

Grants 70% — above average
70%
Career Allowance Rate
154 granted / 219 resolved
At TC average
Strong +16% interview lift
Without
With
+16.2%
Interview Lift
resolved cases with interview
Typical timeline
2y 3m
Avg Prosecution
53 currently pending
Career history
267
Total Applications
across all art units

Statute-Specific Performance

§101
0.2%
-39.8% vs TC avg
§103
42.5%
+2.5% vs TC avg
§102
34.7%
-5.3% vs TC avg
§112
21.3%
-18.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 219 resolved cases

Office Action

§102
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 . Election/Restrictions Applicant's election with traverse of Species B (figs.13A-18) read on claims 1-20 in the reply filed on 07/02/2026 is acknowledged. The traversal is on the ground(s) that there is no search burden. This is not found persuasive because each of the different species disclose different structure that needs to be search independently. The requirement is still deemed proper and is therefore made FINAL. 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) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Misra (US6012586A) Regarding claim 1, Misra teaches a packaging system comprising (fig.1 shows the packaging): a tray including (fig.1 shows the tray 10): a retention section that includes a retention feature on a first side of the tray (fig.1 shows the retention section 82 on with the cavity being a retention feature on the first side of the tray 10), the retention feature being adapted to retain a medical device (fig.1 the cavity of 82 being capable of being able to retain a medical device; it is noted that medical device is not positively claimed and holds no patentable weight); and a first end portion coupled to the retention section and adapted to bend relative to the retention section (fig.1 shows the first end 20 coupled to section 82 and capable of bending relative to the retention section); wherein the packaging system is adaptable to (it is noted that due to “adaptable to” following limitation are not positively claimed and will be treated as capable to limitations; Regarding the intended use of the claimed invention “configured to.....”, it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. If the prior art structure is capable of performing the intended use, then it meets the claim. Ex parte Masham, 2 USPQ2d 1647 (1987).): (i) a first state in which the first end portion is bent towards the first side of the tray and coupled to a first engagement feature on the first side of the tray to hold the medical device (fig.1 tray 10 is capable of being in a first state where the first end 20 bends towards the first side of the tray and coupled to the first engagement feature on the first side of the tray to hold the medical device); and (ii) a second state in which the first end portion is bent towards a second side of the tray and coupled to a second engagement feature on the second side of the tray to provide a support structure for one end of the tray (fig.1 tray 10 is capable of being in a second state where the first end 20 bends towards the second side of the tray and coupled to the second engagement feature on the second side of the tray to provide support structure for one end of the tray) Regarding claim 2, the references as applied to claim 1 above discloses all the limitations substantially claimed. Misra further teaches wherein the tray includes a sheet of material that includes the retention section and the first end portion (“The entire kit is then sealed in an airtight plastic wrapper (not shown) to keep the materials therein sterile”-Col.6 lines 63-65). Regarding claim 3, the references as applied to claim 1 above discloses all the limitations substantially claimed. Misra further teaches wherein the first end portion of the tray is adapted to bend at multiple locations to form multiple sections that incrementally bend towards the second side of the tray (fig.1 the section 46 allows the first end portion of the tray 10 to bend at multiple location along 46 towards the second side). Regarding claim 4, the references as applied to claim 3 above discloses all the limitations substantially claimed. Misra further teaches wherein at least one of the multiple sections is adapted to bend to contact the second side of the tray (fig.1 the multiple section capable of bending to contact eh second side of the tray 10). Regarding claim 5, the references as applied to claim 1 above discloses all the limitations substantially claimed. Misra further teaches a retainer removably attachable to the tray; wherein, in the first state, the retainer is coupled to the first side of the tray to retain the medical device in the retention feature, and, in the second state, the retainer is positioned adjacent to the second side of the tray to receive the first end portion of the tray (“The entire kit is then sealed in an airtight plastic wrapper (not shown) to keep the materials therein sterile”-Col.6 lines 63-65 and during the prep configuration it can be positioned adjacent to the bottom side of the tray). Regarding claim 6, the references as applied to claim 1 above discloses all the limitations substantially claimed. Misra further teaches wherein the tray further includes a second end portion, and, in the first state, the second end portion is bent onto the first side of the tray to cover the medical device (fig.1 the second end portion 38 with flexible part 48 that is capable of bending onto the first of the tray). Regarding claim 7, the references as applied to claim 1 above discloses all the limitations substantially claimed. Misra further teaches a plug removably attachable to a hole in a fluid containment feature within the tray, the plug is located at a position in the tray a distance from the hole and adapted to be removed from the position (fig.5 shows the plug 86 in a hole 85 in the tray and located at a position in the tray a distance from the hole and capable of being removed from the position). Regarding claim 8, Misra teaches a packaging tray comprising (fig.1 shows the packaging tray): a retention section that includes a retention feature on a first side of the packaging tray, the retention feature being adapted to retain a medical device (fig.1 shows the retention section 82 on with the cavity being a retention feature on the first side of the tray 10 capable of retaining a medical device); and a first end portion coupled to the retention section and adapted to bend relative to the retention section, the first end portion being adaptable to (fig.1 shows the first end 20 coupled to section 82 and capable of bending relative to the retention section): (i) a first configuration in which the first end portion is bent towards the first side of the packaging tray and coupled to a first engagement feature on the first side of the packaging tray (fig.1 tray can be in first configuration in which the first end is bend towards the first side and coupled to a first engagement feature on the first side); and (ii) a second configuration in which the first end portion is bent towards a second side of the packaging tray and coupled to a second engagement feature on the second side of the packaging tray to provide a support structure for one end of the packaging tray (fig.1 tray 10 can be in second configuration in which the first end 20 can be bent towards the second side of the tray and coupled to the second engagement feature on the second side of the tray provide a support structure). It is noted that applicant has not positively claimed the medical device, the bending, the configurations and all the structure with the configurations hence they do not need to be disclosed by the prior art just has to be capable of performing that function which it does. Regarding claim 9, the references as applied to claim 8 above discloses all the limitations substantially claimed. Misra further teaches wherein the retention section and the first end portion are formed of a same sheet of material (fig.1 the retention section and the first end are formed of the same sheet material). Regarding claim 10, the references as applied to claim 8 above discloses all the limitations substantially claimed. Misra further teaches wherein the first end portion of the packaging tray is adapted to bend at multiple locations to form multiple sections that incrementally bend towards the second side of the packaging tray (fig.1 the section 46 allows the first end portion of the tray 10 to bend at multiple location along 46 towards the second side). Regarding claim 11, the references as applied to claim 10 above discloses all the limitations substantially claimed. Misra further teaches wherein at least one of the multiple sections is adapted to bend to contact the second side of the packaging tray (fig.1 the multiple section capable of bending to contact eh second side of the tray 10). Regarding claim 12, the references as applied to claim 8 above discloses all the limitations substantially claimed. Misra further teaches wherein the packaging tray further includes a second end portion, and, in the first configuration, the second end portion is bent onto the first side of the packaging tray to cover the medical device (fig.1 the second end portion 38 with flexible part 48 that is capable of bending onto the first of the tray). Regarding claim 13, the references as applied to claim 8 above discloses all the limitations substantially claimed. Misra further teaches wherein at least one of the packaging tray or the medical device is sterilized (“The entire kit is then sealed in an airtight plastic wrapper (not shown) to keep the materials therein sterile”-Col.6 lines 63-65). Regarding claim 14, Misra a packaging tray comprising (fig.1 shows the packaging ray): a retention section that includes a retention feature on a top side of the packaging tray to receive a medical device (fig.1 shows the retention section 82 on with the cavity being a retention feature on the first side of the tray 10 capable of retaining a medical device); and a flexible section adapted to flex relative to the retention section, the flexible section to implement (fig.1 the section 18 and 24 capable of flexing due to 46 relative to the retention section): (i) a packaged configuration in which the flexible section flexes in a first direction and attaches to the top side of the packaging tray (see fig.1 where the packaged configuration where the 46 flexes in first direction and attached to the top side of the tray); and (ii) a device-preparation configuration in which the flexible section flexes in a second direction and attaches to a bottom side of the packaging tray (see fig.1 where the device preparation configuration where the 46 flexes in first direction and attached to the bottom side of the tray). Regarding claim 15, the references as applied to claim 14 above discloses all the limitations substantially claimed. Misra further teaches wherein the retention section and the flexible section are formed of a same sheet of material (fig.1 the two sections are formed of the same material). Regarding claim 16, the references as applied to claim 14 above discloses all the limitations substantially claimed. Misra further teaches wherein the flexible section is adapted to bend at multiple locations to form multiple sections that incrementally bend towards the bottom side of the packaging tray (fig.1 the section 46 allows the first end portion of the tray 10 to bend at multiple location along 46 towards the second side). Regarding claim 17, the references as applied to claim 14 above discloses all the limitations substantially claimed. Misra further teaches wherein the packaging tray further includes another flexible section, and, in the packaged configuration, the other flexible section flexes and attaches to the top side of the packaging tray (fig.1 the second end portion 38 with flexible part 48 that is capable of bending onto the first of the tray). Regarding claim 18, the references as applied to claim 14 above discloses all the limitations substantially claimed. Misra further teaches a retainer removably attachable to the packaging tray; wherein, in the packaged configuration, the retainer is coupled to the top side of the packaging tray to retain the medical device in the retention feature, and, in the device- preparation configuration, the retainer is positioned adjacent to the bottom side of the packaging tray to receive the flexible section (“The entire kit is then sealed in an airtight plastic wrapper (not shown) to keep the materials therein sterile”-Col.6 lines 63-65 and during the prep configuration it can be positioned adjacent to the bottom side of the tray). Regarding claim 19, the references as applied to claim 14 above discloses all the limitations substantially claimed. Misra further teaches a plug removably attachable to a hole in a fluid containment feature within the packaging tray, the plug is located at a position in the packaging tray a distance from the hole and adapted to be removed from the position (fig.5 shows the plug 86 in a hole 85 in the tray and located at a position in the tray a distance from the hole and capable of being removed from the position). Regarding claim 20, the references as applied to claim 19 above discloses all the limitations substantially claimed. Misra further teaches wherein the flexible section is located on one side of the packaging tray and the position of the plug is located on another side of the packaging tray (fig.1 and 5 show the locations of the two are different). Conclusion See PTO-892 for the prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Applicant claims are written claim very little structure of the inventive concept that even refence like Misra reads on it. Applicant is suggested to claim more structure as disclosed or at least positively claim the limitations. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PRINCE PAL whose telephone number is (571)272-7525. The examiner can normally be reached M-Th, 9:30 AM - 7:30 PM (EST). 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, ANTHONY STASHICK can be reached on (571)272-4561. 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. /PRINCE PAL/Examiner, Art Unit 3735
Read full office action

Prosecution Timeline

Apr 10, 2025
Application Filed
Jul 17, 2026
Non-Final Rejection mailed — §102 (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
70%
Grant Probability
86%
With Interview (+16.2%)
2y 3m (~11m remaining)
Median Time to Grant
Low
PTA Risk
Based on 219 resolved cases by this examiner. Grant probability derived from career allowance rate.

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