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 .
Response to Applicants Arguments/Amendments
Claims 27-28, 33-49 are under examination.
Applicants have significantly amended the instant set of claims, providing greater clarity. As a results of the recent claim amendments, the former 35 U.S.C. 112(a) Rejection, 35 U.S.C. 112(b) Rejection, and 35 U.S.C 103 art rejection are withdrawn and new rejections put forward. The examiner has also decided to rejoin species I that encompasses the species TGF-beta and BMP because both belong to the TGF beta superfamily and have similar functions.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 27-28,33-49 are rejected under 35 U.S.C. 103 as being unpatentable over Song (US 20030185809) in view of Pancook (WO 2018200322)
Song discloses a method of treating osteoarthritis in a mammal (Paragraph 2 of Song) in need thereof, comprising:
generating a recombinant vector comprising a DNA sequence encoding transforming growth factor β (TGF-β) or bone morphogenic protein (BMP) operatively linked to a promoter (Paragraphs 29-30 of Song);
transfecting or transducing a first population of mammalian cells in vitro with said recombinant vector (Paragraphs 29-30 of Song);
injecting an injectable mixed cell composition comprising hyaline cartilage-generating and osteoarthritis treating effective amount of:
the first population of cells transduced with a gene encoding TGF-β or BMP (Paragraphs 29-31 of Song); and
a second population of chondrocyte cells that have not been transfected for transduced with a gene encoding TGF-β or BMP (Paragraphs 29-31 of Song);
a pharmaceutically acceptable carrier thereof that is not a non-living three dimensional structure, into a joint space of the mammal such that expression of the DNA sequence encoding TGF-β or BMP within the joint space occurs resulting in generation of bone and cartilage tissue in the joint space, wherein a ratio of the second population of chondrocyte cells that have not been transfected or transduced with a gene encoding TGF-β or BMP to the first population of cells that have been transfected or transduced with a gene encoding TGF-β or BMP is from about 1-20 to 1 (Paragraphs 30, 32,37,54,68,84,90 of Song) as in instant Claims 27,33,44-45
Song teaches a first population of host cells transduced with a gene encoding TGF-β or BMP. Song does not teach that the first population of host cells are human embryonic kidney cells such as HEK293 cells.
Pancook’s invention, “embodies vectors and host cells for the propagation of nucleic acid sequences encoding said proteins and the production thereof (Abstract of Pancook).” The host cells produce proteins that can be used to treat conditions such as osteoarthritis (Abstract of Pancook). Pancook teaches that HEK293 (a host cell) can be used to produce proteins of interest (Page 12, 3rd paragraph).
It would have been obvious to an artisan of ordinary skill at the time of effective filing to have transfected/transduced the population of HEK293 cells of Pancook in place of the first population of cells taught by Song since the HEK293 cells can also successfully produce proteins which can be used in a treatment for osteoarthritis (Abstract and Page 12, 3rd Paragraph of Pancook). There would have been a high expectation for success using the HEK293 cells with the process of Song because Pancook teaches that HEK293 cells successfully produce desired proteins following the introduction of vectors into the HEK293 cells (Abstract and Page 12, 3rd Paragraph of Pancook) as in instant Claim 27-28.
Dependent Claims taught by Song
Song teaches wherein said gene encodes TGF-β or BMP-2 (Paragraph 31 of Song) as in instant Claims 33 and 45. Song teaches wherein said ratio of the second population of chondrocyte cells that have not been transfected or transduced with a gene encoding TGF-β or BMP to the first population of cells that have been transfected or transduced with a gene encoding TGF-β or BMP is from about 3-20 to 1 (Paragraph 32 of Song) as in instant Claims 34 and 46. Song teaches wherein said ratio is from about 3-10 to 1 (Paragraph 32 of Song) as in instant Claims 35 and 47. Song teaches wherein said ratio is from about 10 to 1 (Paragraph 32 of Song) as in instant Claims 36 and 48. Song teaches wherein the first population of cells transfected or transduced with a gene encoding TGF-β or BMP is irradiated (Paragraph 26 of Song) as in instant Claims 37 and 49. Song teaches wherein the first population of cells transfected or transduced with the gene encoding TGF-β or BMP and the second population of chondrocyte cells not transfected or transduced with a gene encoding TGF-β or BMP are syngeneic or xenogeneic with respect to the mammal (Paragraph 34 of Song) as in instant Claim 38. Song teaches the recombinant vector is a viral vector (Paragraph 35 of Song) as in instant Claim 39. Song teaches wherein the recombinant vector is a plasmid (Paragraph 35 of Song) as in instant Claim 40. Song teaches wherein the first population of cells transfected or transduced with the gene encoding TGF-β or BMP and the second population of chondrocyte cells not transfected or transduced with a gene encoding TGF-β or BMP are stored prior to transplantation (Paragraph 36 of Song) as in instant Claim 41. Song teaches wherein the first population of cells transfected or transduced with gene encoding TGF-β or BMP and the second population of chondrocyte cells not transfected or transduced with a gene encoding TGF-β or BMP are stored in a cryopreservative prior to transplantation (Paragraph 36 of Song) as in instant Claim 42. Song teaches wherein said transfection or transduction is accomplished by liposome encapsulation, calcium phosphate coprecipitation, electroporation, DEAE-dextran mediation or virus mediation (Paragraph 35 of Song) as in instant Claim 43.
Song teaches a mixed cell therapy that uses a heterogenous population of cells to treat osteoarthritis. One of the cell populations of Song is a host cell that has undergone transfection/transduction with a recombinant vector allowing for it to produce TGF-beta and/or BMP. Song does not teach that this host cell is a human embryonic kidney cell. However, an artisan would have been motivated to have used such a cell since Pancook teaches that HEK293 cells can undergo transfection/transduction with a vector in order to produce TGF-beta superfamily proteins. Therefore, these HEK293 host cells of Pancook can be used in place of the host cells taught in Song since they can undergo transfection/transduction and serve as a host cell. Given the teachings of the cited references and the level of skill of an artisan at the time of applicants’ invention, it must be considered absent evidence to the contrary that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All of the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007)). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.'s and Ph.D.'s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology, cryopreservation, cell culture, and treating osteoarthritis.
Conclusion
All claims stand rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638