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 .
Claims 76-92 are pending. Claims 1-75 and 93-95 have been cancelled. Applicant’s election without traverse of claims 75-92 in the reply filed on April 20, 2026 is acknowledged. Applicant has cancelled non-elected claims.
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.
Claims 76-78,81,82,84,87 and 89-92 are rejected under 35 U.S.C. 103 as being unpatentable over Helagson (US 2017/0306428)
Helagson teaches synthetic leathers (paragraph 0119) can be manufactured by collagen type I and type III (paragraph 0120) produced from fibroblasts (paragraphs 0122-0123) in a medium containing transforming growth factor beta (paragraph 0126), collagen, elastin, fibronectin and laminin (paragraph 0128, 0143). Helagson teaches tanning the synthetic leather produced from the fibroblasts with vegetable, chrome, aldehyde or syntan tanning agents or bacterial dyeing (paragraph 0172). Helagson teaches using bovine origin fibroblasts for seeding onto scaffolds (paragraph 0229-0230) which can be rayon (paragraph 0109). Helagson teaches introducing c-Myc (oncogene, immortalizes fibroblast by increasing proliferation) into the cells or mutated polynucleotides (paragraph 0004, 0070).
Helagson does not teach all the claimed limitations in a single embodiment but on of ordinary skill in the art can arrive at the claimed invention by selecting from the teachings of Helagson.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to form a tanned synthetic leather by introducing exogenous polynucleotides into bovine fibroblasts, seeding the fibroblasts onto scaffolds such as silk to produce collagen sheets and tanning the collagen sheets as Helagson teaches this is an effective way of producing synthetic leather which can be tanned using vegetable, chrome, aldehyde or syntan tanning agents and dyed using bacterial dyeing. Helagson teaches it is known to introduce gene alterations (mutations) into the fibroblasts and also introduce oncogenes such as c-Myc, which inherently increase cell proliferation by immortalizing the cells. Using known cellular components and additives, seeding them on scaffolds to produce artificial leather sheets of collagen and tanning to produce synthetic leather products is known in the art as taught by Helagson.
Claims 76-78,81-87 and 89-92 are rejected under 35 U.S.C. 103 as being unpatentable over Helagson (US 2017/0306428) in view of Netti (EP 1589098) and Ozer (SV-40 mediated Immortalization of Human Fibroblasts. Experimental Gerontology, Vol 31, Nos. ½, pp. 303-310, 1996).
Helagson is relied upon as set forth above.
Helagson does not teach tumor suppressor proteins or exogenous polynucleotide that encodes for SV large T antigen.
Netti teaches a method for forming bioengineered leather (paragraph 0068) by introducing exogenous polynucleotides such as those that cause expression of T antigen SV40 virus (tumor suppressor) into bovine fibroblasts and seeding the fibroblasts onto scaffolds (paragraphs 0053-0058) wherein the T antigen SV40 expression will cause the cells to behave as immortalized which inherently increases proliferation (paragraph 0086). Netti teaches polylactic acid scaffolds (paragraph 0025).
Ozer teaches that infection of fibroblast cells with DNA virus SV-40 which encode and cause the cell to express T-antigen (page 304, first paragraph; page 305, last paragraph; page 306, paragraph 2).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the methods of Helagson by introducing exogenous polynucleotides such as those that cause expression of T antigen SV40 virus, a tumor suppression protein, into the fibroblasts as Netti teaches this immortalizes the cells and therefore allows them to proliferate indefinitely. Indefinite proliferation would allow for indefinite production of cells and collagen sheets. It would have been obvious to induce expression of T antigen SV40 virus by adding exogenous polynucleotide as Ozer teaches infection of fibroblast cells with DNA virus SV-40 which encode and cause the cell to express T-antigen cause cell immortalization and increase cell life. It would have been further obvious to modify the methods of Helagson by using a polylactic acid scaffold as Netti teaches these scaffold effectively seed and grow bovine fibroblasts for use in bioengineered leather.
Claim 79 is rejected under 35 U.S.C. 103 as being unpatentable over Helagson (US 2017/0306428) in view of Caperlla-Monsonis (An experimental toolbox for characterization of mammalian collagen type I in biological specimens. Nature Protocols, Vol 13, no 3, 2018, 507-529).
Helagson is relied upon as set forth above.
Helagson does not teach collagen production determination by Sircol red assay.
Caperlla-Monsonis teaches that collagen production from fibroblast cells is conventionally determined using Sircol collagen assay using red dye (table 1, concentration, Sircol collagen assay; page 510, left column, collagen concentration assessment).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the methods of Helagson by using Sircol red assay to determine the collagen production amount as Caperlla-Monsonis teaches that Sircol collagen assay with Sirius red dye is commercially available and conventionally used to detect collagen I concentrations in biological samples. Using a known and commercially available assay to detect collagen in biological specimens is obvious.
Claims 80-84 are rejected under 35 U.S.C. 103 as being unpatentable over Helagson (US 2017/0306428) in view of in view of Netti (EP 1589098) and Ozer (SV-40 mediated Immortalization of Human Fibroblasts. Experimental Gerontology, Vol 31, Nos. ½, pp. 303-310, 1996) and further in view of Donai (Bovine and porcine fibroblasts can be immortalized with intact karyotype by the expression of mutant cyclin dependent kinase 4, cyclin D, and telomerase. Journal of Biotechnology, 176, (2014) pp. 50-57).
Helagson, Netti and Ozer are relied upon as set forth above.
Helagson, Netti and Ozer does not teach cell proliferation determination by automated cell counting and TERT protein..
Donai teaches that bovine fibroblasts are conventionally counted by using an automated cell counter (page 51, section2.5) and CSII-CMV-hTERT were introduced into the cell line (page 51, section 2.1) wherein hTERT immortalized the fibroblasts and accelerated the proliferation and increases telomerase activity (page 52, left column, paragraphs 3-4; page 54, section 4, discussion))
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the methods of Helagson, Netti and Ozer by introducing and exogenous polynucleotide that alters telomerase activity and encodes TERT as Donai teaches introducing polynucleotides which encode TERT cause bovine fibroblasts to become immortalized and have increased telomerase activity. Using known polynucleotides to encode for TERT and immortalize cells to increase cell proliferation would be advantageous in a method that requires cell proliferation and collagen production. Netti teaches the advantages of using immortalized fibroblasts to prepare bioengineered leather. Using a known exogenous polynucleotide which also immortalizes similar bovine fibroblasts would be obvious to increase cell proliferation and increase the life span of the fibroblasts making more cells available for collagen production.
Claims 80-84 are rejected under 35 U.S.C. 103 as being unpatentable over Helagson (US 2017/0306428) in view of Donai (Bovine and porcine fibroblasts can be immortalized with intact karyotype by the expression of mutant cyclin dependent kinase 4, cyclin D, and telomerase. Journal of Biotechnology, 176, (2014) pp. 50-57).
Helagson is relied upon as set forth above.
Helagson does not teach cell proliferation determination by automated cell counting and TERT protein..
Donai teaches that bovine fibroblasts are conventionally counted by using an automated cell counter (page 51, section2.5) and CSII-CMV-hTERT were introduced into the cell line (page 51, section 2.1) wherein hTERT immortalized the fibroblasts and accelerated the proliferation and increases telomerase activity (page 52, left column, paragraphs 3-4; page 54, section 4, discussion))
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the methods of Helagson by introducing and exogenous polynucleotide that alters telomerase activity and encodes TERT as Donai teaches introducing polynucleotides which encode TERT cause bovine fibroblasts to become immortalized and have increased telomerase activity. Using known polynucleotides to encode for TERT and immortalize cells to increase cell proliferation would be advantageous in a method that requires cell proliferation and collagen production. Using a known exogenous polynucleotide which also immortalizes similar bovine fibroblasts would be obvious to increase cell proliferation and increase the life span of the fibroblasts making more cells available for collagen production.
Claim 88 is rejected under 35 U.S.C. 103 as being unpatentable over Helagson (US 2017/0306428) in view of Forgacs (WO 2014/201406)
Helagson is relied upon as set forth above.
Helagson does not teach decellularized cell layers.
Forgacs teaches preparing engineered leather from fibroblasts (paragraph 0046,0072) and using decellularized sheets stacked and adhered together to form a substrate which is tanned (abstract, paragraph 0056, 00103). Forgacs teaches decellularizing prevents contractions (paragraph 0032).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the methods of Helagson by preparing decellularized sheets of collagen as Forgacs teaches decellularizing collagen sheets allows them to be stacked and adhered into a substrate without contractions and the substrate can be tanned into an engineered leather product. Using a known method of producing thicker collagen sheets that don’t contract from fibroblasts which can be effectively tanned would be obvious to produce an engineered leather.
Conclusion
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/AMINA S KHAN/Primary Examiner, Art Unit 1761
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