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 .
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.
Claim(s) 1-19 and 20-23 is/are rejected under 35 U.S.C. 102(a1) as being anticipated by Avila-Ramirez (International Journal of Bioprinting (2021)).
Avila-Ramirez sets forth 3D printable bio-functional carbonate-based inks for reconstruction of rigid living systems under wet conditions—see title and abstract.
Regarding carbonate-based ink of claims 1-11:
Avila-Ramirez sets forth obtaining inks comprising a biopolymer base and a bioceramic [pp. 66, 1st col. last paragraph] by mixing a two-part formulation [pp. 66, last line 1st col. to first line 2nd col.]. Said two-part formulation comprises a biopolymer (cl. 1) composition comprising gelatin (claim 1 and 4); alginate (alginic acid—claim 1, 4, 8); high degree methacrylated gelatine methacrylate (claim 3-4); polyethylene glycol diacrylate (claim 3-4 and 9, i.e., polyether); Milli-Q water (claim 2, 4, 10); and lithium phenyl(2,4,6-trimethylbenzoyl) phosphinate (claim 3-4 and 6), as a photoinitiator for photocrosslinking between 365 nm to 405 nm and a bioceramic composition comprising hydroxyapatite (cl. 1 and 7) and calcium carbonate (1, 3, and 11—see figure 1 and Table 1 both on pp. 67. Avila-Ramirez teaches structures comprising said bio-functional carbonate-based inks can be printed or molded in air or under wet conditions, wherein Avila-Ramirez sets forth seawater from the Red Sea (cl. 5 and 10)—see pp. 69, last line left col. to 1st line right col. Thus, the carbonate-based ink of claims 1-11 is anticipated/known.
Regarding the process limitations found in claim 1, lines 7-8 and claim 4, lines 10-15 in relation to the teachings of Avila-Ramirez: The biopolymer portion of the two-part formulation are mixed, with the exception of the photoinitiator, and dissolved in water. The photoinitiator is added to the dissolved biopolymer mixture. The bioceramic composition is mixed with said biopolymer composition to obtain the biofunctional ink formulation (composition)—see pp 66, lasted paragraph in 2nd column to pp. 67, 1st paragraph in left col. Additionally, the courts have upheld, “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 the product does not depend on the method of production. Therefore, 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—see In re Thorpe, 227 USPQ 967 (Fed. Cir. 1985).
Regarding the method of manufacturing in claims 12-18; the method of applying of claims 19; and the device of claims 21-23:
Avila-Ramirez teaches structures comprising said bio-functional carbonate-based inks can be printed or molded in air or under wet conditions, wherein Avila-Ramirez sets forth seawater from the Red Sea (cl. 12-13)—see pp. 69, last line left col. to 1st line right col. The ink of Avila-Ramirez as discussed above anticipates the ink of claims 12 and 14-18.
Regarding the method and composition of claims 12-19: Said two-part formulation dissolving a biopolymer composition comprising gelatin; alginate; high degree methacrylated gelatine methacrylate; and polyethylene glycol diacrylate in Milli-Q water under heat condition of a maximum temperature of 50 deg. C before adding the lithium phenyl(2,4,6-trimethylbenzoyl) phosphinate photoinitiator in absence of light to not trigger premature polymerization and adding the bioceramic composition comprising hydroxyapatite and calcium carbonate to the dissolved biopolymer mixture—see pp. 66, last paragraph right col..
Regarding claims 19 and the device of claims 20-22: Avila-Ramirez sets forth methods of obtaining 3D structures using two methods: molding and 3D printing using a) a pressure-based bioprinter (claim 23, an injectable device) and a bioprinting using a robotic arm—see page 67, last paragraph, right col.
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.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Avila-Ramirez as applied to claims 1-19 and 21-23 above.
Avila-Ramirez is set forth above as anticipating the instantly claimed carbonate-based ink composition. The primary difference is Avila-Ramirez does not expressly set forth a kit comprising an effective amount of said carbonate-based ink. However, as set forth above Avila-Ramirez explicitly anticipates the instantly claimed ink composition, as well as, additionally teaching said formulation has the potential use for rigid living system having tunable properties which could fulfill different directions regarding the final user’s needs—see page 73, last lines in 1st paragraph in right col. Therefore, in absence of evidence to the contrary, it is deemed a skilled artisan could immediately envision for “at-home” use kits for consumers with an expectation of successfully obtaining 3D composites for at home use. Thus, claim 20 is deemed obvious in view of the overall teachings.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANZA L MCCLENDON whose telephone number is (571)272-1074. The examiner can normally be reached 8-5.
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/SANZA L. McCLENDON/ Primary Examiner, Art Unit 1765