DETAILED ACTION
Applicants claim amendments filed 11/27/2024 are acknowledged and entered into the record.
Accordingly, Claims 1, 2, 4-6, 8-20, 22-25, 30, 32, 34-35 are pending and will be examined on the merits.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA
Claim Objections
Claim 9 is objected to because of the following informalities: Claim 9 recites “sodium gluconate” twice. Appropriate correction is required.
Claim 32 is objected to because of the following informalities: Claim 32 depends from canceled claim 31. Appropriate correction is required. For examination purposes Claim 32 will be examined as being dependent from Claim 30.
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, 2, 4-6, 8-20, 22-25, 30, 32, 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Ma et al. (US PgPub 2021/0069100) in view of Carmona et al. (US PgPub 2020/00263196) both cited on IDS filed 4/29/2024.
The claims are directed to a composition comprising a population of hydrogel capsules disposed in a pharmaceutically acceptable aqueous solution, wherein each hydrogel capsule in the population encapsulates a plurality of live mammalian cells.
Ma et al. discloses a composition comprising a population of hydrogel capsules (para [0024]: population of hydrogel capsules encapsulating cells) disposed in a pharmaceutically acceptable aqueous solution (para [0138]: incubation step is carried out in an aqueous solution containing the physiological salt in an amount effective to stabilize the capsules), wherein each hydrogel capsule in the population encapsulates a plurality of live (para [0158]) mammalian cells (para [0020]), wherein the solution has a pH of between 6.0 and 9.0 at 12 degrees C to 30 degrees C (para [0168]) and comprises a divalent salt (BaCl2) at concentration of 20mM (para [0168]) and wherein the cells are derived from an induced pluripotent stem cell (para [0119]: the cell can be a stem cell (e.g., pluripotent). Ma et al. further discloses wherein various cations including calcium are utilized for crosslinking at concentrations as low as 5 mM (para [0130]) and wherein Ca2+ may be utilized for crosslinking (para [0134]). Ma et al. further discloses a composition similar to the composition of claim 1 (para [0024]) and further discloses wherein each hydrogel capsule in the population comprises an ionically cross-linked alginate (para [0134]). Ma et al. discloses wherein each hydrogel capsule in the population has a sphere-like or spherical shape and comprises: (c) a cell-containing compartment which comprises the plurality of live cells encapsulated in a first polymer composition (para [0020]) and (d) a barrier compartment surrounding the cell-containing compartment (para [0020]: outer barrier layer) wherein the mean diameter of the hydrogel capsules in the population is about 1400 microm to about 1800 microm (para [0023]: 1.5 mm) and further discloses wherein they hydrogel layer comprises an ionically cross-linked alginate (para [0134]). Ma et al. discloses wherein the mean capsule diameter of the hydrogel capsules in the population is 1400 to 2000 microm (para [0023]: 1.5 mm) and wherein the thickness of the barrier compartment (shell) can be designed for various applications (para [0158]) and controlled by tuning flow rate (para [0160]). Ma et al. disclose in para [0024] wherein the live mammalian cells are genetically modified to express and secrete a therapeutic substance (para [0022]) and a method of treating a subject (abstract) in need of a therapeutic substance comprising providing said composition and administering a therapeutically effective amount of the composition to the subject (abstract).
Carmona et al. discloses mammalian cells (para [0118]) encapsulated in alginate hydrogels (para [0469]); wherein the composition can comprise a carbon source/ glucose (para [0153]: glucose). Carmona et al. disclosed mammalian cells (para [0118]) encapsulated in alginate hydrogels (para [0469]); wherein the cells express a FV\II protein (para [0148]). and further discloses wherein the carbon source is glucose (para [0153]) and mammalian cells (para [0118]) encapsulated in alginate hydrogels (para [0469]); wherein the cells are derived from an RPE cell (para [0004]).
It would have been prima facie obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Ma et al. and Carmona et al. to make and use a pharmaceutical composition comprising hydrogel capsules comprising a plurality of mammalian (human) cells which express a therapeutic polypeptide such as FVIII. One of ordinary skill in the art would have been motivated to do so because Ma et al. and Carmona et al. teach alginate hydrogels comprising cells expressing therapeutic polypeptides for the treatment of a targeted patient population, disease or disorder such as clotting factor for hemophiliacs as taught by Carmona et al. Furthermore, "[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), and see M.P.E.P. § 2144.05 II.A. Moreover, it is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272,276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804,809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989). It would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal ranges of pH, concentration, osmolarity, and temperature because optimal ranges is an art-recognized result-effective variable which would have been routinely determined and optimized in the pharmaceutical hydrogel art and which is taught by both Ma et al. and Carmona et al. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable range involves only routine skill in the art.
Conclusion
Claims 1, 2, 4-6, 8-20, 22-25, 30, 32, 34-35 are rejected.
No Claim is allowed.
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/Meera Natarajan/Primary Examiner, Art Unit 1643
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