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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10 January 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 3 is objected to because of the following informalities: There are two claims numbered as claim 3. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bouchard et al. (J. of Supercritical Fluids, 2007, Vol. 40, 293-307).
Claim 1 is drawn to a composition comprising protein particles prepared by a method comprising:
dissolving a protein in water to prepare an aqueous solution of the protein;
providing an organic solvent mixture comprising a first organic solvent, which is immiscible with water, and a second organic solvent, which is miscible with water;
providing a continuous oscillatory baffled crystallizer with an inlet and an outlet, and allowing the organic solvent mixture to run from the inlet of the continuous oscillatory baffled crystallizer and out from the outlet of the continuous oscillatory baffled crystallizer;
injecting the aqueous solution of the protein dropwise through a point between the inlet and the outlet of the continuous oscillatory baffled crystallizer to form droplets of the aqueous protein solution, whereupon the second organic solvent diffuses into the droplets of the aqueous protein solution and the first organic solvent suspends the droplets of the aqueous protein solution; and
allowing a formation of protein crystals, wherein the formed protein crystals agglomerate to form substantially spherical protein particles towards the outlet of the continuous oscillatory baffled crystallizer,
wherein the spherical protein particles have an average particle size between 1-500 µm.
The first claim 3 is drawn to the composition of claim 1, wherein the protein is lysozyme.
Bouchard et al. teach production of lysozyme particles (Title, Abstract), further teaching in Fig. 3 on pg. 297 microspheres of lysozyme having a size of 1-15µm.
Bouchard et al. do not teach the lysozyme spheres being produced by the instantly claimed method. However, as discussed in MPEP 2113(I), "even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). As further discussed in MPEP 2113(II), "The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983).
Based on all of the foregoing, claims 1 and 3 are anticipated.
Claim 2 is drawn to the composition of claim 1, wherein the protein is biologically active.
Bouchard et al. further teach the lysozyme maintaining bioactivity after being formed into spheres (pg. 304 left column last paragraph).
As such, claim 2 is anticipated.
The second claim 3 is drawn to the composition of claim 1, wherein the first solvent is ethyl acetate and the second solvent is ethanol.
The second claim 3 limits the process recited in claim 1, but does not provide any further structural limitation on the protein particles of claim 1. As such, the second claim 3 is anticipated for the same reasons applied to claim 1 above.
Claim 4 is drawn to a composition comprising protein particles, wherein the protein particles have an average particle size between 1-500 µm and are biologically active.
Claim 5 is drawn to the composition of claim 4, wherein the protein is lysozyme.
Bouchard et al. teach formation of lysozyme particles (Title, Abstract) further teaching in Fig. 3 on pg. 297 microparticles having a size of 1-40 µm. Bouchard et al. additionally teach the lysozyme maintaining bioactivity after being formed into particles (pg. 304 left column last paragraph).
As such, claims 4-5 are anticipated.
Conclusion
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/PAUL HOERNER/Examiner, Art Unit 1611
/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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