Prosecution Insights
Last updated: April 19, 2026
Application No. 18/076,777

INTEGRATED PACKAGE FOR ADMINISTRATION OF LYOPHILIZED MEDICINES

Final Rejection §102
Filed
Dec 07, 2022
Examiner
STIGELL, THEODORE J
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Psc Biotech Corporation
OA Round
2 (Final)
78%
Grant Probability
Favorable
3-4
OA Rounds
3y 4m
To Grant
93%
With Interview

Examiner Intelligence

Grants 78% — above average
78%
Career Allow Rate
975 granted / 1245 resolved
+8.3% vs TC avg
Moderate +15% lift
Without
With
+14.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
45 currently pending
Career history
1290
Total Applications
across all art units

Statute-Specific Performance

§101
0.8%
-39.2% vs TC avg
§103
31.3%
-8.7% vs TC avg
§102
31.7%
-8.3% vs TC avg
§112
21.1%
-18.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1245 resolved cases

Office Action

§102
DETAILED ACTION Response to Amendment Claim Rejections - 35 USC § 102 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) 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koska (US 10,835,678). In regard to claim 1, Koska discloses an auto-disable prefillable integrated package apparatus (10; see Figs. 10-11 for reference), comprising: a first chamber (30a); a second chamber (30b); a connector (36) configured to form a communicable channel between the first chamber and the second chamber (see at least Fig. 11); a frangible membrane (“temporary seal”; see col. 13, line 42- col. 14, line 10) configured to form a rupturable barrier within the connector that separates the first chamber and the second chamber (the temporary seal is placed at the end of first chamber 30a adjacent to the one-way valve 26; this is considered within valve cover 36); and a hub (11 and 20) configured to be communicably coupled to the second chamber (see at least Figs. 1 and 11); and a bonded periphery (see peripheral portions of 14) coupled to the hub and surrounding the first chamber and the second chamber (see at least Figs. 1 and 10-11; see col. 9, line 4- col. 11, line 4). In regard to claim 2, Koska discloses wherein the second chamber (30b) comprises a compressible inner volume (“second compressible reservoir member 30b”; see col. 13, line 56). In regard to claim 3, Koska discloses further comprising a valve (26) configured to prevent fluid flow from the second chamber into the first chamber via the connector (see at least col. 13, line 22- col. 14, line 10). In regard to claim 4, Koska discloses further comprising a needle assembly (11) configured to be communicatively coupled to the hub (in this interpretation, only 20 would be considered the hub). In regard to claim 5, Koska discloses wherein the bonded periphery comprises a bond formed between a top half (14) of the integrated package apparatus and a bottom half (12) of the integrated package apparatus (see col. 10, line 60-col. 11, line 4). In regard to claim 6, Koska discloses wherein the frangible membrane is configured to rupture when a mechanical force above a rupture threshold is applied by a user to the connector (see col. 13, line 42- col. 14, line 10). In regard to claim 7, Koska discloses wherein the hub comprises a port (22). In regard to claim 8, Koska discloses wherein the valve (26) comprises a disc valve (see col. 10, lines 22-33). In regard to claim 9, Koska discloses wherein the frangible membrane comprises a polymer compound (see col. 5, lines 25-32). Response to Arguments Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 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, Michael Tsai can be reached at 571-270-5246. 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. THEODORE J. STIGELL Primary Examiner Art Unit 3783 /THEODORE J STIGELL/ Primary Examiner, Art Unit 3783
Read full office action

Prosecution Timeline

Dec 07, 2022
Application Filed
Oct 20, 2025
Non-Final Rejection — §102
Nov 20, 2025
Interview Requested
Dec 03, 2025
Interview Requested
Dec 05, 2025
Applicant Interview (Telephonic)
Dec 05, 2025
Examiner Interview Summary
Jan 21, 2026
Response Filed
Mar 19, 2026
Final Rejection — §102 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

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2y 5m to grant Granted Mar 24, 2026
Patent 12582811
Instrument Delivery Device with Nested Housing
2y 5m to grant Granted Mar 24, 2026
Patent 12569672
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2y 5m to grant Granted Mar 10, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
78%
Grant Probability
93%
With Interview (+14.6%)
3y 4m
Median Time to Grant
Moderate
PTA Risk
Based on 1245 resolved cases by this examiner. Grant probability derived from career allow rate.

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