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 .
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.
Claim 2 is 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.
Claim 2, “the polyvinyl alcohol” lacks antecedent basis. For examination purposes, it is believed to further limit “a soluble component removed” in claim 1. This limitation has been interpreted as a product by process limitation which fails to differentiate the final product. For example, if the polyvinyl alcohol is the outer most surface of the outer layer before removal, after removal, the remaining outer layer is the outer layer.
Claim Objections
Claim 20 is objected to because of the following informalities: delete “are” in the first occurrence.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-11, 13-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kroll et al (2020/0164109).
Kroll et al (2020/0164109) teaches an artificial blood vessel comprised of multiple layers; figure 15 shows an example of three layers.
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Par. 0058 In certain embodiments, these cell-laden ink layers of the multi-layered tubular tissue construct described herein may be referred to as a first, a second, a third, etc.
Claim 1 of Kroll et al teaches a multiple-layered tubular construct (blood vessel, see par. 0009) wherein each layer comprising filaments comprising cell-laden ink of one or more cell types. Claim 15 teaches partially surrounding said one or more filaments with extracellular matrix composition which includes fibrinogen and thrombin. Par. 0009 reads: The method may further include a step of depositing one or more sacrificial filaments on the substrate prior to at least partially surrounding the one or more cell-laden filaments with the extracellular matrix composition to form a sacrificial filament network (soluble component) interpenetrating the one or more cell-laden filaments, each of the sacrificial filaments comprising a fugitive ink (soluble component). The network may comprise flow channels in fluid communication with the cell-laden filaments for perfusion thereof after removal of the fugitive ink (soluble component).
Further see at least par. 0088 teaching the extracellular matrix may comprise a silicone gel etc. which is elastic and flexible; and combinations including polyvinyl alcohol (soluble component). Regarding, an elastic outer layer “having a soluble component removed”, see par. 0091 teaching the fugitive ink is dissolved in a suitable aqueous solution. This would further remove the polyvinyl alcohol.
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Claim 6 of Kroll et al teaches the cells can be selected from smooth-muscle-cells and endothelial cells. The breath of claim 6 includes a first inner layer comprised of a smooth muscle cell gel comprised of smooth muscle cells, and fibrinogen and thrombin (claim 15); and a second inner layer comprised of an endothelial cell gel comprised of endothelial cells, and fibrinogen and thrombin (claim 15), wherein the first inner layer is between the elastic outer layer and the second inner layer.
Kroll et al further teaches the method may further include a step of injecting a suspension of endothelial cells into the open perfusable lumen after the fugitive ink is removed. The injected endothelial cells may form the intimal layer of a blood vessel. The cell-laden ink layers may form a medial layer and an adventitial layer of a blood vessel. The multi-layered tubular construct may be structurally and functionally similar or the same as a blood vessel, or be a blood vessel. Also see par. 0093.
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2. The blood vessel of claim 1, wherein the fugitive ink or polyvinyl alcohol are both soluble components. See par. 0091 teaching dissolving in a suitable aqueous solution.
Using deionized water versus a suitable aqueous solution is a product-by-process limitation which fails to differentiate the final product.
3. The blood vessel of claim 1, wherein the outer layer is comprised of a biodegradable elastomer such as polyvinyl alcohol, collagen, fbronectin, etc. See par. 0088.
4. The blood vessel of claim 1, wherein the smooth muscle cells and endothelial cells are human induced pluripotent stem cell derived, see at least par. 0020. Also, this is considered a product-by-process limitation which does not differentiate the final product.
5. The blood vessel of claim 1, wherein the smooth muscle cell gel and the endothelial cell gel are injected coaxially using a needle is considered a product-by-process limitation which does not differentiate the final product.
6. The blood vessel of claim 1, wherein the smooth muscle cell gel and the endothelial cell gel are both extruded from different compartments of the same coaxial needle. See figure 1. Also, this is considered a product-by-process limitation which does not differentiate the final product.
7. The blood vessel of claim 1, wherein the second inner layer is formed after the first inner layer is considered a product-by-process limitation which does not differentiate the final product.
8. The blood vessel of claim 1, wherein the blood vessel has high elasticity and porosity has been interpreted broadly wherein the blood vessel of Kroll et al fulfills.
9. The blood vessel of claim 1, wherein the smooth muscle cells are first mixed with the fibrinogen solution and then coaxially extruded with the thrombin is considered a product-by-process limitation which does not differentiate the final product.
10. The blood vessel of claim 1, wherein the endothelial cells are first mixed with the fibrinogen solution and then coaxially extruded with the thrombin is considered a product-by-process limitation which does not differentiate the final product.
11. All limitations are addressed in claim 1 above except the following: See claim 40 of Kroll et al teaching the tubular construct (blood vessel) is printed. As stated in claim 1 above and discussed in par. 0088, the layers, which includes the outer layer, can comprise polyvinyl alcohol which will be removed using a suitable aqueous solution. Further see the included teachings above regarding it’s well known to remove PVA in water.
13. The method of claim 11, wherein the outer layer is comprised of a biodegradable elastomer such as polyvinyl alcohol, collagen, fbronectin, etc.
14. The method of claim 11, wherein the smooth muscle cells and endothelial cells are human induced pluripotent stem cell derived, see at least par. 0020.
15. The method of claim 11, wherein the smooth muscle cell gel (cell laden ink) is injected coaxially using a needle (nozzle) shown in figure 1.
16. The method of claim 11, wherein the smooth muscle cell gel (cell laden ink) and the endothelial cell gel (extracellular matrix gel composition) are both extruded from different compartments of the same coaxial needle (nozzle) shown in figure 1.
17. The method of claim 11, wherein the second inner layer is formed after the first inner layer. Kroll et al further teaches the method of injecting a suspension of endothelial cells into the open perfusable lumen after the fugitive ink is removed. The injected endothelial cells form the intimal layer (second layer) of a blood vessel.
18. The method of 11, wherein the blood vessel has high elasticity (relative language in which the blood vessel of Kroll et al is interpreted as fulfilling) and has a rough surface (relative language in which the blood vessel of Kroll et al is interpreted as fulfilling. Further, see par. 0088 teaching the layers, which includes the outer layer, can be a copolymer comprising polyvinyl alcohol which is removed by the body following implantation leaving the other copolymer. Finally, the removal of the fugitive ink leaves a porous surface (at least the inner lumen)).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kroll et al (2020/0164109).
Kroll et al (2020/0164109) teaches an artificial blood vessel and its method of producing including printing an outer layer, removing PVA in an aqueous solution, and forming a first and second layers as claimed. As noted above, water is a well-known aqueous solution to remove PVA.
However, it is unclear if the aqueous solution is deionized water. First, it would have been obvious to one having ordinary skill in the art to have used water as the “suitable aqueous solution”. It would have been obvious for one having ordinary skill in the art to have tried deionized water for the water with a reasonable expectation of success in dissolving the PVA.
Allowable Subject Matter
Claims 19-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
The examiner considers Kroll et al to be the closest prior art of record, however, fails to teach the combination of claim 11 including:
Claim 19: wherein the smooth muscle cells are first mixed with the fibrinogen solution and then coaxially extruded with the thrombin.
Claim 20: wherein the endothelial cells are first mixed with the fibrinogen solution and then coaxially extruded with the thrombin.
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.”
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCE EDWARD SNOW whose telephone number is (571)272-4759. The examiner can normally be reached 7:30 am - 5:00 pm Monday through Thursday.
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/BRUCE E SNOW/Primary Examiner, Art Unit 3774