DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11 April 2025 has been entered.
Claims 14, 28, and 29 have been amended. Claims 21-24 remain withdrawn. Claims 14-20 and 25-32 are currently pending and under examination.
This Application is a Continuation of U.S. Application No. 15/531532, filed May 30, 2017, now U.S. Patent No. 10,744,160, which is a national phase application under 35 U.S.C. §371 of International Application No. PCT/RU2015/000831, filed November 30, 2015, and claims priority to Russian Patent Document No. RU2014148251, filed December 1, 2014.
Withdrawal of Rejections:
The rejection of claims 14, 17-20, 25-27, 30, and 31 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn.
The rejection of claims 14-17, 25, and 27-30 under 35 U.S.C. 103 as being unpatentable over Terzic et al., in view of Lee et al., is withdrawn.
The rejection of claims 14, 19, 20, and 26 under 35 U.S.C. 103 as being unpatentable over Terzic et al. and Lee, and further in view of Brem et al., is withdrawn.
Maintenance of Objections:
Claim Objections
Claims 18, 31, and 32 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.
New Rejections:
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 14-16, 20, 25 and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Gordon-Beresford et al. (IDS; US 2012/0301538, Published Nov. 29, 2012).
With regard to claims 14-16, 20, and 28, Gordon-Beresford et al. teach a composition comprising a pharmaceutical composition and pharmaceutically acceptable excipient, the composition for in vivo administration to a human or animal (Abs.; Para. 9, 48), which is a subject. The composition can be prepared using any appropriate manner, including being prepared from conditioned media from cells, such as cardiomyocyte cells or TNF-α-stimulated endodermal cells (Para. 69), which are a single cell line. The pharmaceutical composition containing one or more of: VEGF, TGF-β1, TGF-β2 (Para. 24, 39, 40; claims 1, 5, 6). The pharmaceutically acceptable excipient including phosphate buffered solution (PBS), Hartmann’s solution, Ringer’s lactate, or physiological NaCl (Para. 73), which are liquid carriers.
The VEGF is present in an amount including between 0.5 and 400 ng/ml (500-400,000 pg/ml) (Para. 68). The TGF-β, including TGF-β1 and TGF-β2, is present in an amount between 0.1 and 100 ng/ml (100-100,000 pg/ml). As Gordon-Beresford et al. expressly teach that the pharmaceutical composition includes one or more components that comprise VEGF, TGF-β1, and TGF-β2, it would have been obvious to an ordinary artisan to include these expressly taught components together in the composition. Additionally, it would have been obvious to an ordinary artisan to utilize an amount of VEGF within the expressly taught range of 500-400,000 pg/ml, which fully encompasses at least 4,000 pg/ml, and from 4,000 to 15,000 pg/ml. Further, it would have been obvious to an ordinary artisan to utilize an amount of TGF-β1 and TGF-β2 within the expressly taught range of 100-100,000 pg/ml, which fully encompasses at least 750 pg/ml and at least 67 pg/ml TGF-β1, and at least 250 pg/ml and at least 170 pg/ml TGF-β2. Additionally, the VEGF, TGF-β1 and TGF-β2 together are present in a total amount from 700 to 600,000 pg/ml, which fully encompasses at least 12,150 pg/ml.
With regard to claim 25, Gordon-Beresford et al. teach that the composition itself does not contain cells (claims 1, 5, 6).
With regard to claim 27, the composition of Gordon-Beresford et al. does not contain any OPG (see claims 1, 5, 6). Therefore, the conditioned media contains 0 pg/ml, which is less than 50 pg/ml, of OPG.
With regard to claim 29, Gordon-Beresford et al. teach that therapeutic applications of the composition include treatment of heart diseases and regeneration of cardiac tissue (Para. 9), which is treatment and healing of organs and tissue.
Claims 14, 17, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Gordon-Beresford et al., as applied to claim 14 above, and further in view of Lee et al. (IDS; US 2013/0058903, Published March 7, 2013).
The teachings of Gordon-Beresford et al. as applied to claim 14 have been set forth above. Gordon-Beresford et al. do not teach that the conditioned medium further comprises IL-10 and IP-10, or that the single cell line is a mesenchymal stem cell line.
With regard to claims 17 and 30, Lee teaches a composition comprising a conditioned medium, the conditioned medium obtained by culturing a population of cells, wherein the conditioned medium contains a mixture of factors including TGF-β1, TGF-β2, and VEGF, and further includes IL-10 and IP-10 (Para. 27, Line 1-3; Para. 40), and wherein the composition further comprises a pharmaceutical carrier for administration (Para. 44, Line 3-8). The composition is usable for treatment of cardiac tissue (Para. 75, claim 8, 12, 13). Additionally, a mesenchymal stem cell line may be utilized to produce conditioned media containing a mixture of factors (Abs.; Para. 5).
It would have been obvious to one of ordinary skill in the art to combined the teachings of Gordon-Beresford et al. and Lee, because both teach compositions comprising conditioned media that include a mixture of factors including VEGF, TGF-β1, and TGF-β2, a carrier, and the treatment of cardiac tissue. The further inclusion of IL-10 and IP-10 in a composition comprising VEGF, TGF-β1, and TGF-β2 for treatment of cardiac tissue is known in the art as taught by Lee. It would have been obvious to one of ordinary skill in the art to further include IL-10 and IP-10 as taught by Lee in the composition of Gordon-Beresford et al., because IL-10 and IP-10 would have been expected to predictably and successfully provide further factors known to treat cardiac tissue as desired. Additionally, the use of MSCs for the production of conditioned media containing a mixture of factors is known in the art as taught by Lee. The use of a MSC line amounts to the simple substitution of one known factor-producing cell line for another, and would have been expected to predictably and successfully provide conditioned media containing a mixture of factors as desired.
Claims 14, 19, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Gordon-Beresford et al., as applied to claim 14 above, and further in view of Brem et al. (IDS; US 2010/0310517, Published 2010).
The teachings of Gordon-Beresford et al. as applied to claim 14 have been set forth above. Gordon-Beresford et al. do not teach that the composition further comprises a preservative and surfactant, wherein the preservative is one or more of thimerosol, cresols, formalin, benzalkonium chloride, or benzyl alcohol, and where the surfactant is Triton™ X-100.
With regard to claims 19 and 26, Brem et al. teach a composition for treatment of skin, where the composition comprises growth factors including VEGF (Abs.). The skin care composition for topical application additionally includes surfactants and preservatives, the preservatives including benzalkonium chloride, thimerosal, benzyl alcohol, and phenol (cresol), and the surfactant including polyoxyethylene octylphenyl ether (Triton™ X-100) (Para. 64, 68, 70).
It would have been obvious to one of ordinary skill in the art to combined the teachings of Gordon-Beresford et al. and Brem et al., because both teach a composition that comprises VEGF for treatment of a condition. The inclusion of a preservative and surfactant, the preservative including benzalkonium chloride, thimerosal, benzyl alcohol, and phenol (cresol), and the surfactant including polyoxyethylene octylphenyl ether (Triton™ X-100), in a composition comprising VEGF, is known in the art as taught by Brem et al. The addition of a preservative and surfactant as taught by Brem et al., to the composition of Gordon-Beresford et al. would have been expected to predictably improve the composition by allowing for an additional use, including to treat skin by topical application of the composition.
Response to Arguments
In view of Applicant’s amendments, all previous rejections have been withdrawn. Therefore, Applicant’s arguments are moot. However, new rejections have been set forth above.
Conclusion
No claims are allowable. However, claims 18, 31, and 32 appear to be free of the art.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653