Office Action 2: Notice of Allowance (2024-12-05)

CLAIMS:
Listing of Claims

PENDING CLAIMS

1-20. (Canceled)219

21\. (Previously Presented) An exosome comprising a fusion protein which is present on an exterior surface of the exosome, wherein the fusion protein comprises (i) an immunomodulating component and (ii) a prostaglandin F2 receptor negative regulator (PTGFRN) or a functional fragment thereof, and wherein the immunomodulating component comprises a cytokine.

22\. (Previously Presented) The exosome of claim 21, wherein the cytokine comprises an interleukin-12 (IL-12) protein or an interleukin-15 (IL-15) protein.

23\. (Previously Presented) The exosome of claim 22, wherein the cytokine is fused to the N- terminus of the PTGFRN or functional fragment thereof.

24\. (Previously Presented) The exosome of claim 21, wherein the PTGFRN comprises the full- length PTGFRN.

25\. (Previously Presented) The exosome of claim 21, wherein the functional fragment of the PTGFRN comprises the region before the C-terminal-most IgV domain, the transmembrane domain, and the intracellular domain of PTGFRN.

26\. (Previously Presented) The exosome of claim 22, wherein the cytokine is an IL-12 protein and the fusion comprises the amino acid sequence set forth in SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, or SEQ ID NO: 6.

27\. (Previously Presented) The exosome of claim 22, wherein the cytokine is an IL-15 protein and the fusion protein comprises the amino acid sequence set forth in SEQ ID NO: 15 or SEQ ID NO: 16.

28\. (Previously Presented) The exosome of claim 26, wherein the PTGFRN or functional fragment thereof comprises: (i) amino acid residues 561-1,418 of SEQ ID NO: 3; (ii) 564-1,421

of SEQ ID NO: 4; (iii) amino acid residues 561-753 of SEQ ID NO: 5; or (iv) amino acid residues 563-756 of SEQ ID NO: 6.

29\. (Previously Presented) The exosome of claim 27, wherein the PTGFRN or functional fragment thereof comprises: (i) amino acid residues 561-1,418 of SEQ ID NO: 3; (ii) 564-1,421 of SEQ ID NO: 4; (iii) amino acid residues 561-753 of SEQ ID NO: 5; or (iv) amino acid residues 563-756 of SEQ ID NO: 6.

30\. (Previously Presented) The exosome of claim 22, which comprises one or more additional immunomodulating components.

31\. (Previously Presented) The exosome of claim 28, wherein the one or more additional immunomodulating components comprise (i) an inhibitor for a negative checkpoint regulator or an inhibitor for a binding partner of a negative checkpoint regulator; (ii) an activator for a positive costimulatory molecule or an activator for a binding partner of a positive co-stimulatory molecule; (iii) a cytokine or a binding partner of a cytokine; (iv) a T-cell receptor (TCR), a T-cell co-receptor, a major histocompatibility complex (MHC), a human leukocyte antigen (HLA), or a derivative thereof; (v) an activator of a T-cell receptor or co-receptor; (vi) a tumor antigen; (vii) an agonist or an antagonist; (viii) an antibody or an antigen-binding fragment; (ix) a polynucleotide; (x) a protein, a peptide, a glycolipid, or a glycoprotein; or (xi) combinations thereof.

32\. (Previously Presented) The exosome of claim 30, wherein the one or more additional immunomodulating components comprise a CD40L, a FLT3L, or both.

33\. (Previously Presented) The exosome of claim 32, wherein (a) the CD40L is present on the exterior surface of the exosome as a fusion protein, (b) the FLT3L is present on the exterior surface of the exosome as a fusion protein, or (c) both (a) and (b).

34\. (Previously Presented) The exosome of claim 33, wherein the fusion protein comprising the CD40L comprises the amino acid sequence set forth in SEQ ID NO: 19 or SEQ ID NO: 20.

35\. (Previously Presented) The exosome of claim 33, wherein the fusion protein comprising the FLT3L comprises the amino acid sequence set forth in SEQ ID NO: 22.

36\. (Previously Presented) A composition comprising the exosome of claim 21, and a pharmaceutically acceptable carrier.

37\. (Previously Presented) A composition comprising the exosome of claim 22, and a pharmaceutically acceptable carrier.

38\. (Previously Presented) A composition comprising the exosome of claim 26, and a pharmaceutically acceptable carrier.

39\. (Previously Presented) A composition comprising the exosome of claim 27, and a pharmaceutically acceptable carrier.

40\. (Previously Presented) A composition comprising the exosome of claim 30, and a pharmaceutically acceptable carrier.

OFFICE ACTION:
DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 21-40 are pending.
Terminal Disclaimer
The terminal disclaimer filed on 10/09/2024 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Patent Nos. 10723782 and 12030924 has been reviewed and is accepted.  The terminal disclaimer has been recorded.
The following is an examiner’s statement of reasons for allowance: The approved terminal disclaimer noted above is effective to overcome the rejections previously applied.  Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee.  Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”

APPLICANT REBUTTAL: REMARKS
Reconsideration of this Application is respectfully requested. Claims 21-40 are pending in the application. No new amendments are made; the listing of claims is included for convenience.
Based on the following remarks, Applicant respectfully requests that the Examiner reconsider all outstanding objections and rejections and that they be withdrawn.
Rejection of claims 21-25, 30, 32, 33, 36, 37, and 40 due to alleged nonstatutory double patenting
The Office rejects claims 21-24, 30, 32, 33, 36, 37 and 40 due to alleged nonstatutory double patenting over claims 1-8 and 10-17 of U.S. Patent No. 12,030,924. The Office also rejected claims 21, 22, 24, 25, 36, and 37 over claims 1, 2, 5-7, 9, 10, 17, and 18 of U.S. Patent No. 10,723,782.
Solely to advance prosecution of this application to allowance and without acquiescence to the double patenting rejections, Applicant files along with this reply a terminal disclaimer over the cited patents. In view of this terminal disclaimer, the Applicant respectfully requests withdrawal of the double patenting rejections.
CONCLUSION