Prosecution Insights
Last updated: July 17, 2026
Application No. 18/506,575

Compositions Containing Protein Loaded Exosome and Methods for Preparing and Delivering the Same

Final Rejection §DP
Filed
Nov 10, 2023
Priority
May 04, 2015 — RE 10-2015-0062604 +11 more
Examiner
HAMA, JOANNE
Art Unit
1647
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Ilias Biologics Inc.
OA Round
2 (Final)
25%
Grant Probability
At Risk
3-4
OA Rounds
12m
Est. Remaining
64%
With Interview

Examiner Intelligence

Grants only 25% of cases
25%
Career Allowance Rate
65 granted / 259 resolved
-34.9% vs TC avg
Strong +39% interview lift
Without
With
+38.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
26 currently pending
Career history
287
Total Applications
across all art units

Statute-Specific Performance

§101
4.7%
-35.3% vs TC avg
§103
57.3%
+17.3% vs TC avg
§102
8.3%
-31.7% vs TC avg
§112
14.9%
-25.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 259 resolved cases

Office Action

§DP
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 . The amendments of 03/10/2023 have been entered in full. Claims 13, 14, and 17-25 are pending. All prior objection/rejections not specifically maintained in this Office action are hereby withdrawn in view of Applicants’ amendment and/or arguments filed 02/10/2026. Claim Objections Applicant is advised that should claim 22 be found allowable, claim 23 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp. Claim 13, 14, and 17-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 13, and 18 of U.S. Patent No. 11872193. Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to overlapping subject matter. Patented claim 1 is drawn to a generic exosome comprising a cargo and a photo-specific binding protein. Patented claims 2-5 encompass embodiments wherein the cargo protein is inside the exosome and not bound to the exosome membrane. Patented claims 13 and 18 recite that the cargo protein is super-suppressor IkB. Therefore, generic patented claim 1 encompasses an exosome comprising super-suppressor IkB inside the exosome and not bound to the exosome membrane, as recited in pending claims 13 and 14. The recitation of SEQ ID NO: 5 in pending claim 13 does not distinguish the claim because a person of skill in the art seeking to make and use the patented composition comprising super-suppressor IkB would consult the specification of Patent No. 11872193 and find that SEQ ID NO: 5 is the amino acid sequence of super-suppressor IkB. Therefore, SEQ ID NO: 5 is inherent property of super-suppressor IkB and the sequence would alternatively be obvious to one of skill in the art. Patented dependent claims 6-10 and pending claims 17-21 likewise overlap in scope as they add the same limitations to the overlapping independent claims. The species recited in pending claims 22-24 are encompassed with patented claim 1 in view of patented claims 6,7, 13, and 18. Exosomes are smaller than 200 nm according to the definition in the common specification of Patent No. 11872193. Therefore, claim25 recites a property that is inherent in the patented exosomes. Conclusion No claim is allowed. 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 DANIEL C GAMETT, Ph.D., whose telephone number is (571)272-1853. The examiner can normally be reached on M-W. Please note the examiner’s part-time schedule. 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, Joanne Hama can be reached on 5712722911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /DANIEL C GAMETT/Primary Examiner Art Unit 1647
Read full office action

Prosecution Timeline

Nov 10, 2023
Application Filed
Dec 10, 2025
Non-Final Rejection mailed — §DP
Mar 10, 2026
Response Filed
Jun 04, 2026
Final Rejection mailed — §DP (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

3-4
Expected OA Rounds
25%
Grant Probability
64%
With Interview (+38.8%)
3y 8m (~12m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 259 resolved cases by this examiner. Grant probability derived from career allowance rate.

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