DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. Applicant’s amendment of claims 1, 3, 4, 6-8, 10-12, 14-16, 18-24, 26, and 27 in the reply filed on 05 August 2026 is acknowledged.
3. Applicant’s cancellation of claims 9, 17, and 25 in the reply filed on 05 August 2026 is acknowledged.
Claim Rejections - 35 USC § 103
4. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
5. Claims 1-8, 10, 12-16, 18, 20-24, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (WO 2020/047380 A1; cited in Applicant’s IDS) in view of Champlin (“Selection of Autologous or Allogeneic Transplantation”) and Hu (CA 3098924 A1).
Regarding claims 1, 12, and 21, Thomas ‘380 teaches a method of treating a blood vessel defect in a subject in need thereof ([00078]) comprising implanting a vascular graft in a subject, wherein the vascular graft comprises (a) a polymeric substrate at least partially coated by an endothelial cell attachment agent ([0009]) and (b) human endothelial cells adhered to said coated polymeric substrate ([0008], [0009]).
Thomas ‘380 teaches a method of implanting a vascular graft in a subject in need thereof ([00080]) comprising implanting a vascular graft in a subject, wherein the vascular graft comprises (a) a polymeric substrate at least partially coated by an endothelial cell attachment agent ([0009]) and (b) human endothelial cells adhered to said coated polymeric substrate ([0008], [0009]).
Thomas ‘380 teaches a vascular graft comprising (a) a polymeric substrate at least partially coated by an endothelial cell attachment agent ([0009]) and (b) human endothelial cells adhered to said coated polymeric substrate ([0008], [0009]).
Regarding the human endothelial cells are allogeneic cells:
Paragraph [00047] of Thomas ‘380 recites in part “As used herein, the term“universally acceptable” refers general acceptance of cell products in immunological terms, where cross- matching of patients and cells is not required, and no immunosuppression is needed”, and paragraph [00053] of Thomas ‘380 recites in part “Accordingly, stored or “banked” cells having particular predetermined characteristics are available upon demand. Preferably, banked cells representing many HLA types from healthy individuals are stored in cell banks in order to provide haplotype matches for all potential recipients in a particular population. In some cases, banked cells useful for the vascular grafts and methods provided herein are induced pluripotent stem cells (iPSCs) derived from screened and HLA-typed donors”. Therefore, Thomas ‘380 teaches the human endothelial cells can include allogeneic cells.
Further, this is already well known in the art. For example, Champlin teaches the pros (i.e., advantages) of allogenic cells when implanting matter into the body (paragraph 4). Notice, the first paragraph of Champlin clearly establishes the well-known fact about selection of autologous versus allogeneic (or vice versa), i.e., the selection depending on the particular medical condition and needs of the patient. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of the benefits of allogenic cells, as taught by Champlin, to modify the graft of Thomas ‘380 to include allogenic cells, in order to cater the implant to a patient’s specific needs and reduce vascular disease reoccurrence (paragraph 4).
Regarding the human endothelial cells are not major histocompatibility complex (MHC) matched to the subject:
Paragraph [00047] of Thomas ‘380 recites in part “In some cases, a cell’s genome is modified (e.g., engineered) such that the modified cell “universally acceptable” for therapeutic applications. As used herein, the term “universally acceptable” refers general acceptance of cell products in immunological terms, where cross-matching of patients and cells is not required, and no immunosuppression is needed. In some cases, the cell is modified such that functional proteins encoded by either the class II or both the class I and the class II major histocompatibility complex genes do not appear on the cell’s surface”. Therefore, Thomas ‘380 teaches the human endothelial cells are not major histocompatibility complex (MHC) matched to the subject, since cross-matching of patients and cells is not required, and no immunosuppression is needed.
Regarding the human endothelial cells have not been genetically modified to reduce rejection by the immune system:
Paragraph [0008] of Thomas ‘380 recites in part “The human arterial endothelial cells can be produced from human pluripotent stem cells” and “The human arterial endothelial cells can be non-immunogenic to a recipient of the vascular graft”, suggesting the human endothelial cells can be used without any of the genetic modifications.
Paragraph [00045] of Thomas ‘380 implies that the cells can or may be modified but it does not require it.
Further, this is already well known in the art. For example, Hu ‘924 teaches wherein the genetic modification of cells can cause undesired side effects (pg. 2, lines 17-25). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of the negative side effects of genetic modification, as taught by Hu ‘924, to the make the graft of Thomas ‘380 free of undesired side effects, e.g., in order to avoid tumorigenesis (pg. 2, lines 17-25).
Regarding claim 2, Thomas ‘380 teaches wherein the vascular graft is implanted to replace a portion of a diseased or damaged blood vessel ([00078]).
Regarding claim 3, Thomas ‘380 teaches wherein the portion of the damaged vessel is a result of trauma ([00078]).
Regarding claim 4, Thomas ‘380 teaches wherein the portion of the diseased or damaged vessel is a result of vascular disease ([00078]).
Regarding claims 5 and 13, Thomas ‘380 teaches wherein the vascular graft is implanted by anastomosis ([00080]).
Regarding claims 6, 14, and 22, Thomas ‘380 teaches wherein the vascular graft prevents thrombosis in the subject ([0008], [00088]).
Regarding claims, 7, 15, and 23, Thomas ‘380 teaches wherein the vascular graft maintains long-term patency (Abstract; [00088]). Regarding maintaining patency for at least 6 months, a person having ordinary skill in the art will be left with the choice of, e.g., particular shape and materials of the vascular graft; particular amount of endothelial cells attached to the vascular graft; etc., in order to achieve a desired patency (e.g., for at least 6 months). Further, Thomas ‘380 in view of Champlin and Hu ‘924 discloses the invention as claimed. Therefore, the capability of maintaining patency for at least 6 months is inherent.
Regarding claim 8 and claim 16, Thomas ‘380 in view of Champlin and Hu ‘924 discloses the invention as claimed. Therefore, the capability of the allogeneic hECs to be replaced by the subject's endothelial cells is inherent. Notice, the claim language lacks description on how exactly the allogeneic hECs are to be replaced by the subject's endothelial cells.
Regarding claims 10, 18, and 26, Thomas ‘380 teaches wherein the endothelial cells are arterial endothelial cells ([0008]).
Regarding claim 20, Thomas ‘380 teaches wherein the vascular graft is implanted during congenital heart surgery, coronary artery bypass surgery, or peripheral vascular surgery ([00078]).
6. Claim(s) 11, 19, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (WO 2020/047380 A1; cited in Applicant’s IDS) in view of Champlin (“Selection of Autologous or Allogeneic Transplantation”) and Hu (CA 3098924 A1), as applied to claim 1 above, in view of Li (AU 2001283108 A1).
Regarding claims 11, 19, and 27, Thomas ‘380 in view of Champlin and Hu ‘924 does not exactly teach the use of venous endothelial cells. However, it is well known in the art venous endothelial cells, have an advantage or easier harvesting. For example, Thomas ‘380 teaches, wherein harvesting arteries is invasive and challenging ([00044]). Further Li ‘108 teaches a graft being ideal by utilizing the easy harvesting of veins ([0008]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the teachings of veinous cells harvesting taught by Li ‘108 to the graft endothelial cells, as taught by Thomas ‘380, in order to allow for easier harvesting (Thomas ‘380 - [00044], Li ‘108 - [0008]).
Response to Arguments
7. Applicant's arguments filed 05 August 2026 have been fully considered but they are not persuasive:
Applicant’s arguments have been adequately addressed in the rejection above.
In response to applicant's argument that Champlin is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the first paragraph of Champlin clearly establishes the well-known fact about selection of autologous versus allogeneic (or vice versa), i.e., the selection depending on the particular medical condition and needs of the patient.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
8. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure - Laughlin et al. (US PG Pub No. 2004/0258670 A1), teaching cell-based therapies.
Paragraphs [0042], [0044], and [0067] of Laughlin et al. ‘670 teaches endothelial cells “can be allogeneic, autologous or HLA-compatible with the recipient”.
Paragraph [0049] of Laughlin et al. ‘670 teaches an embodiment comprising administering non-genetically modified endothelial cells to a patient.
9. THIS ACTION IS MADE FINAL. 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 Examiner Javier G. Blanco whose telephone number is (571)272-4747. The examiner can normally be reached on M- F (10am-7:30pm).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE Jerrah C. Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAVIER G BLANCO/ Primary Examiner, Art Unit 3774
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