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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the trauma weakened portion, the diseased weakened portion, the anastomosis, and the veinous endothelial cells, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 6, 9-11, 14, 17-19, 22, and 25-27 are objected to because of the following informalities
Claim 6, 10-11, 14, 18-19, 22, and 26-27 recites “the endothelial cells” but should recite “the human endothelial cells”
Claim 9, 17, and 25 recites “the immune system” but should recite “an immune system”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3 and 4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 3 and 4 recite “the weakened portioned vessel” without proper antecedent basis.
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) 1-5, 10, 12-13, 18, 20-21, and 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thomas (WO 2020047380 A1).
Regarding claims 1, 12, and 21, Thomas 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 ([0009]).
Thomas 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 ([0009]).
Thomas 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 ([0009]).
Regarding claim 2, Thomas teaches wherein the vascular graft is implanted to replace a portion of a diseased or damaged blood vessel ([00078]).
Regarding claim 3, Thomas teaches wherein the weakened portioned vessel is a result of trauma ([00078]).
Regarding claim 4, Thomas teaches wherein the weakened portioned vessel is a result of vascular disease ([00078]).
Regarding claims 5 and 13, Thomas teaches wherein the vascular graft is implanted by anastomosis ([00080]).
Regarding claims 10, 18, and 26, Thomas teaches wherein the endothelial cells are arterial endothelial cells ([0008]).
Regarding claim 20, Thomas teaches wherein the vascular graft is implanted during congenital heart surgery, coronary artery bypass surgery, or peripheral vascular surgery ([00078]).
Claim Rejections - 35 USC § 103
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.
Claim(s) 6-7, 14-15, and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (WO 2020047380 A1) in view of Champlin (“Selection of Autologous or Allogeneic Transplantation”).
Regarding claims 6, 14, and 22, Thomas does not teach not autologous cells. However, Champlin teaches the cons of autologous cells when implanting matter into the body (paragraph 3).
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 autologous cells, as taught by Champlin, to modify the graft of Thomas to include allogenic cells, in order to cater the implant to a patient’s specific needs and avoid cell contamination (paragraph 3).
Regarding claims 7, 15, and 23, Thomas does not teach teaches allogeneic cells. However, Champlin teaches the pros of allogenic cells when implanting matter into the body (paragraph 4).
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 to include allogenic cells, in order to cater the implant to a patient’s specific needs and reduce vascular disease reoccurrence (paragraph 4).
Claim(s) 8, 16, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (WO 2020047380 A1) in view of Champlin (“Selection of Autologous or Allogeneic Transplantation”).
Regarding claims 8, 16, and 24 Thomas teaches wherein the human endothelial cells are not major histocompatibility complex (MHC) matched to the subject (for example [00047], cross-matching is not required).
Claim(s) 9 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (WO 2020047380 A1) in view of Champlin (“Selection of Autologous or Allogeneic Transplantation and in further view of Hu (CA 3098924 A1).
Regarding claims 9 and 17, Thomas teaches wherein the human endothelial cells cannot be genetically modified to reduce rejection by the immune system (for example [00045], the prior arts states that the cells can or may be modified but it does not require it). However, Thomas does not exactly teach the lack of genetic modification. Hu 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, to the make the graft of Thomas modification free, in order to avoid tumorigenesis (pg. 2, lines 17-25).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (WO 2020047380 A1) in view of Hu (CA 3098924 A1).
Regarding claim 25, Thomas teaches wherein the human endothelial cells cannot be genetically modified to reduce rejection by the immune system (for example [00045], the prior arts states that the cells can or may be modified but it does not require it). However, Thomas does not exactly teach the lack of genetic modification. Hu 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, to the make the graft of Thomas modification free, in order to avoid tumorigenesis (pg. 2, lines 17-25).
Claim(s) 11, 19, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thomas (WO 2020047380 A1) in view of Li (AU 2001283108 A1).
Regarding claims 11, 19, and 27, Thomas 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 teaches, wherein harvesting arteries is invasive and challenging ([00044]). Further Li 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 to the graft endothelial cells, as taught by Thomas, in order to allow for easier harvesting (Thomas: [00044], Li: [0008]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANNA LOUISE PASQUALINI whose telephone number is (703)756-1984. The examiner can normally be reached Telework 8:30PM-4:30PM EST M-F (occasionally off Fridays).
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/H.L.P./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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