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 .
DETAILED ACTION
The Amendments filed on 2/24/2026 has been received and entered.
Claims 1-3, 6-8, 10, 12-13, 16, 19-23, 28-30, and 32-33 are pending and examined on the merits.
Election/Restrictions
Applicant’s election without traverse of the species biopsy not from an individual, FGF-2 and HGF, CD56, DMEM, gel permeation chromatography, filtration, risk of limb loss, in the reply filed on 2/24/2026 is acknowledged.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 6-8, 10, 12-13, 16, 19-23, 28-30, and 32-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 12310991 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because same method and procedure are claimed.
U.S. Patent No. 12310991 B2 teaches:
1. A method of stimulating angiogenesis in an individual, comprising the step of administering to the individual an effective amount of fibroblast-derived exosomes or one or more biologically active fractions thereof.
2. The method of claim 1, further comprising the steps of: a) obtaining one or more fibroblast cells; b) culturing said fibroblast cells in a culture under conditions to allow for production of exosomes into culture media; c) extracting exosomes from said culture media; and d) administering said extracted exosomes or one or more biologically active fractions thereof into an individual in need of angiogenesis.
3. The method of claim 1, wherein said fibroblasts are derived from a biopsy.
4. The method of claim 1, wherein the fibroblasts are from the individual.
5. The method of claim 1, wherein the fibroblasts are not from the individual.
6. The method of claim 1, wherein said fibroblasts are cultured in a media allowing for fibroblast proliferation.
7. The method of claim 6, wherein said media allowing for fibroblast proliferation comprises one or more factors that are mitogenic for fibroblasts.
8. The method of claim 7, wherein said factors that are mitogenic for fibroblasts include one or more factors selected from the group comprising of: a) FGF-1; b) FGF-2; c) FGF-5; d) EGF; e) CNTF; f) KGF-1; g) PDGF; h) platelet rich plasma; i) TGF-alpha; j) HGF-1; and (k) a combination thereof.
9. The method of claim 1, wherein said fibroblasts are cultured under hypoxia.
10. The method of claim 1, wherein the exosomes are collected from fibroblasts while said fibroblasts are in a proliferating state.
11. The method of claim 1, wherein said exosomes are collected from fibroblasts while said fibroblasts are cultured in a media comprising no proliferation-inducing factors or in media that comprise reduced levels of said proliferation-inducing growth factors compared to standard levels.
12. The method of claim 1, wherein said exosomes are collected from said fibroblasts that have been cultured in 2-8% oxygen for at least 1 day.
13. The method of claim 12, wherein the cells are cultured for 1-15 days.
14. The method of claim 12, wherein the cells are cultured for 5-10 days.
15. The method of claim 1, wherein the cells are passaged for at least 1 passage.
16. The method of claim 1, wherein said exosomes are in a preparation, said preparation comprising less than 5% polyethylene glycol.
17. The method of claim 1, wherein the exosomes are purified using polyethylene glycol.
18. The method of claim 1, wherein the exosomes are purified using ultrafiltration.
19. The method of claim 17, wherein polyethylene glycol is added to the exosomes after purification.
20. The method of claim 1, wherein said exosomes express markers selected from a group consisting of (a) CD63; (b) CD9; (c) MHC I; (d) CD56; and (e) a combination thereof.
21. The method of claim 1, wherein the extracting step comprises anion exchange chromatography under high pressure.
22. The method of claim 21, wherein support for the anion exchange chromatography is functionalized with quaternary amines.
23. The method of claim 21, wherein support for the anion exchange chromatography is in the form of beads.
24. The method of claim 1, wherein the extracting step comprises gel permeation chromatography.
25. The method of claim 15, wherein the gel permeation chromatography occurs after the anion exchange chromatography.
26. The method of claim 24, wherein the gel permeation chromatography occurs before the anion exchange chromatography.
27. The method of claim 1, wherein the extracting step further comprises an enrichment step for the exosomes.
28. The method of claim 27, wherein the enrichment step comprises one or more of centrifugation, clarification, filtration, concentration, and/or ultrafiltration.
29. The method of claim 1, wherein the extracting step further comprises non-specific affinity chromatography.
30. The method of claim 1, wherein the extracting step further comprises filtration.
31. The method of claim 1, wherein the individual is at risk for limb loss, has ischemic heart disease, ischemic brain disease, has a gastrointestinal ulcer, and/or is in need of wound repair.
32. The method of claim 31, wherein the individual in need of wound repair has diabetes.
However, the culture media and source of fibroblast are not taught.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use culture media because culture media is necessary for the growth of fibroblasts in a laboratory setting. One would have been motivated to make fibroblast culturing with culture media for the expected benefit of growing fibroblasts for exosome production. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use fibroblasts not from an individual because fibroblasts not from an individual will be good for general use. One would have been motivated to make fibroblast not for an individual for the expected benefit of making fibroblasts for mass production to the general public. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached Monday-Friday 9-5:30 PM.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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