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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1 April 2026 has been entered.
Claims 1, 29, and 48 have been amended. Claims 15-17, 19, 20, 22, 29, 30, 33, 37-40, 48-50, and 57-59 remain withdrawn. Claims 1-4, 6, and 7 are currently pending and under examination.
This application is a National Phase Application of PCT International Application No. PCT/US2021/020301, filed March 1, 2021; and claims benefit of priority to U.S. Patent Application No. 62/983120, filed February 28, 2020.
Maintained/Modified 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 1-4, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (WO 2017/171497; Published 2017 – US 2020/0297613, Published Sept. 24, 2020 is utilized as an English translation and referred to hereafter – Previously presented).
With regard to claim 1, Kim et al. teach a composition comprising a cell culture medium, the composition comprising collagen I (Para. 49-50), human albumin (Para. 42-44), L-glutamine (Para. 33-35), and NaHCO3 (Para. 33, 38-39). The collagen I is present in an amount including 1-200 µg/mL (Para. 49). The human albumin is present in an amount including 10-1000 µg/mL (Para. 44). The L-glutamine is present in an amount including 10 to 18 parts by weight (Para. 34). The NaHCO3 is present in an amount including 50 to 120 parts by weight (Para. 38).
It would have been routine for an ordinary artisan to determine the appropriate concentration of each component in the cell culture medium in the composition based on the desired end use, including the specific skin wound, disease, or condition to be treated, and the specific patient population (Abs.). Accordingly, one of ordinary skill in the art before the effective filing date would have optimized, by routine experimentation, the concentration of the collagen I, human albumin, L-glutamine, and NaHCO3 to obtain a cell culture medium with the desired properties for the end use. (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Additionally, please also note that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer v. Apotex, 480 F.3d at 1368. The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)). Accordingly, it would have been obvious to optimize the concentration of the components in the composition of Kim, including to 60% to 94% human collagen I, 4% to 15% human albumin, 0.4% to 4% L-glutamine, and 1% to 5% NaHCO3, to result a composition effective to treat the specific skin wound, disease, or condition and patient population desired.
Kim et al. render obvious the composition as claimed, including the components as claimed. As the composition cannot be separated from its function, the composition as rendered obvious by Kim et al. is necessarily capable of performing the function of facilitating the survival and engraftment of cells for transplantation.
With regard to claims 2-4, 6, and 7, Kim et al. render obvious the composition as claimed, including the components as claimed. As the composition cannot be separated from its function, the composition as rendered obvious by Kim et al. is necessarily capable of performing the function of facilitating the survival and engraftment of cells for transplantation, the cells including: human or non-human animal cells; β-cells of pancreatic islets, including human, murine, porcine, or stem cell-derived β-cells; endocrine and/or secretory cells including hepatocytes, parathyroid cells, and adrenal gland cells, and the endocrine cells including alpha cells or stem cell-derived endocrine cells.
Response to Arguments
Applicant urges that Kim does not teach or suggest a composition to facilitate the survival and engraftment of cells for transplantation, such as β-cells of pancreatic islets, and that an ordinary artisan would understand that the nutritional and environmental needs of skin cells in healing skin wounds are different than those for the survival and engraftment of cells for transplantation. Thus, Kim does not provide a teaching or suggestion on how to choose culture media that would facilitate the survival and engraftment of cells for transplantation.
Applicant’s arguments have been fully considered, but have not been found persuasive.
Applicant’s arguments rely on language solely recited in preamble. When reading the preamble in the context of the entire claim, the recitation “to facilitate the survival and engraftment of cells for transplantation” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
In response to applicant's argument that Kim does not teach or suggest a composition to facilitate the survival and engraftment of cells for transplantation, including the specific cell types recited in the dependent claims, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Here, it would have been routine for an ordinary artisan to determine the appropriate concentration of each component in the cell culture medium in the composition based on the desired end use, including the specific skin wound, disease, or condition to be treated, and the specific patient population (Kim: Abs.). Accordingly, one of ordinary skill in the art before the effective filing date would have optimized, by routine experimentation, the concentration of the collagen I, human albumin, L-glutamine, and NaHCO3 to obtain a cell culture medium with the desired properties for the end use. (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Additionally, please also note that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer v. Apotex, 480 F.3d at 1368. The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)). Accordingly, it would have been obvious to optimize the concentration of the components in the composition of Kim, including to 60% to 94% human collagen I, 4% to 15% human albumin, 0.4% to 4% L-glutamine, and 1% to 5% NaHCO3, to result a composition effective to treat the specific skin wound, disease, or condition, and patient population desired.
Kim et al. render obvious the composition as claimed, including the components as claimed. As the composition cannot be separated from its function, the composition as rendered obvious by Kim et al. is necessarily capable of performing the function of facilitating the survival and engraftment of cells for transplantation.
Conclusion
No claims are allowable.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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