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 .
Detailed Action
Restriction/Election
Applicant’s election of group I, claims 51-60 in the reply filed on 02/02/26 is acknowledged. Applicant’s election of the following species is also acknowledged. 1) a specific polysaccharide: sodium alginate 2) a specific structural protein: gelatin 3) specific cells: mammalian cells 4) a specific cross-linking agent: Fibrinogen 5) a specific copper salt: copper (II) sulfate (CuSO4). Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 61-70 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/02/26.
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 51-57 and 60 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hwang et al. (EP3326661 A1, presented in IDS).
Hwang et al. discloses a bio-ink composition comprising cells, 0.01-3 w/v % of hyaluronic acid (HA) or dextran, 0.1-10 w/v % of fibrinogen, 0.1-10 w/v % of one or more cell carrier consisting gelatin, collagen, alginate, agarose ([0009], [0019], [0020], [0021], [0023], [0024], [0026]). Hwang et al. mentions that the inclusion of gelatin and HA in the bio-ink composition is essential ([0074]). (Reads on a polysaccharide and a structural protein). Hwang et al. discloses that said composition comprises a cell culture medium (e.g., buffers, salts) ([0009], [0014], [0039]). Said bio-ink composition further comprises a thrombin solution or a photoinitiator, when the photoinitiator acts to induce a rapid crosslinking upon exposure to light ([0042], [0054]). Hwang et al. discloses that the survival rate of cells is maintained at 80% or more after the printing ([0045]). Hwang et al. discloses a method of bio-printing a structure using a bio-printer connected to a reservoir of said bio-ink that comprises (a) charging a bio-ink composition of the present invention into a three-dimensional bio-printer; (b) three-dimensionally printing a desired tissue-like organ; and (c) cross-linking the three-dimensionally printed bio-ink composition ([0043], [0049]). As it is mentioned above said bio-ink composition further comprises the culture medium, thrombin solution or a photoinitiator, when the photoinitiator acts as a crosslinking agent ([0042], [0046], [0054]). Hwang teaches high viscosity, see page 1, [0002]. Hwang et al. discloses that the survival rate of cells is maintained at 80% or more ([0045]).
Claims 51-53, 55-58 and 60 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ahn et al. (WO 2019/245110 (A1, presented in IDS).
Ahn et al. discloses a bio-ink comprising a first bio-ink obtained by liquefying the extracellular matrix of a decellularized tissue; and a second bio-ink including alginate and/or fibrinogen, when alginate or fibrinogen can be cross-linked abstract, ([0029], [0040]). Ahn et al. discloses that the second bio-ink may include hyaluronic acid, dextran, collagen ([0060], [0077]). (Reads on polysaccharide and structural protein). Ahn et al. discloses that the first bio-ink or the second bio-ink may further include one or more embryonic stem cells-derived stem cells, and human-derived stem cells ([0065]). Ahn et al. discloses that mixing the first bio-ink and the second bio-ink containing alginate or fibrinogen has excellent biocompatibility, which is advantageous for the survival, proliferation and differentiation of cells ([0027]), when a viscosity of the bio-ink ([0045], [0046], Figure 2) falls in the range of the viscosity in present claim 60. Ahn et al. discloses that alginate or fibrinogen can be cross-linked using a solution containing an inorganic salt including salts of calcium (calcium chloride ([0109])), manganese, barium, cobalt, zinc, and copper ([0039], [0040]). Ahn et al. discloses a 3D printed artificial tissue using said bio-ink, wherein an inorganic salt (salts of calcium (calcium chloride ([0109])), manganese, barium, cobalt, zinc, and copper) is used for crosslinking said printed tissue ([0084], [0086], [0087]). Ahn et al. discloses aggregation of the cells in said printed structure, and the survival, proliferation and differentiation of the cells ([0089], [0091], [0134], [0136]). Ahn et al. discloses manufacturing a three-dimensional structure using said bio-ink in a 3-D printing apparatus, stirring said structure in a calcium chloride solution as cross-linking agent to prepare an artificial tissue ([0107]-[0109]).
Claims 51-53, 55-56, 58 and 60 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kang et al. (USPG Pub. 2012/089238 (A1)).
Kang et al. discloses a live cell-containing composition involved in a system for an organ/tissue printing that comprises hyaluronic acid, gelatin, fibrinogen ([0105]), alginate, collagen ([0070], [0071], [0072]), and cells when at least a portion of the cells are viable after they are printed ([0052], [0054], [0070], [0106]). (Reads on polysaccharide and structural protein). Kang et al. discloses that the cell composition comprises buffer solutions ([0052]). Kang et al. further discloses that gelling properties of alginate that may be used for hydrogels in said cell-containing composition are in the presence of divalent cations (e.g., manganese, calcium, strontium, barium) ([0071]). Kang et al. discloses that the cells are placed into the desired position in a 3-D structure that is fabricated using said cell-containing composition ([0113], Fig. 8). Kang et al. discloses 83% of the cell viability and the cells proliferation ([0114], [0115]). Kang et al. discloses using thrombin solution (10 units/ml in 40 mM CaCl2) after fabricating the 3-D structure to induce crosslinking of the fibrinogen, and a buffer (phosphate-buffered saline) for washing the structure ([0080], [0109]). Kang et al. discloses printing a 3-D structure that are printed with a modified inkjet printer using said cells-containing compositions, when after fabricating said structure, thrombin solution (10 units/ml in 40 mM CaCl2) is added into the structure to induce crosslinking of the fibrinogen, and washing said structure with a buffer ([0080], [0109]). Kang et al. further discloses that cells, compositions, support compounds, and/or growth factors may be printed through the same nozzle in a common composition, depending upon the particular tissue (or tissue substitute) being formed ([0072]).
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.
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Hwang et al. (EP3326661 (A1, presented in IDS).
Hwang et al. disclose that the bio-ink composition may comprise one or more cell carrier material comprising collagen and gelatin, however their ratio is not mentioned in said publications. Hwang et al. further mentions that the inclusion of gelatin and HA in the bio-ink composition is essential ([0074]). Thus, it would be obvious for the skilled person to use collagen and gelatin in the composition, when finding the optimal ratio of said components represents routine experimentation for the skilled person in formation of the effective bio-ink composition.
Claims 58-59 are rejected under 35 U.S.C. 103 as being unpatentable over Hwang et al. (EP3326661 A1, presented in IDS) or Kang et al. (USPG Pub. 2012/0089238 (A1)) and further in view of Dvir et al. (US PG Pub. 2016/0106886A1) in combination with Campbell et al. (US PG Pub. 2003/0175410).
Hwang et al. as discussed above teach use of culture medium (buffers and salts), however, the reference does not teach use of copper sulfate salt.
Dvir et al. teaches metal-coated scaffolds for tissue engineering, see title. The reference teaches that the therapeutic compounds or agents that modify cellular activity can also be incorporated (e.g. attached to, coated on, embedded or impregnated) into the scaffold material. Such compounds and agents may be incorporated directly onto the scaffold and/or onto the metal (e.g. gold) nanoparticles themselves. Campbell et al (US Patent Application No. 2003/0175410) which is incorporated by reference as if fully set forth by reference herein, discloses methods for fabrication of 3D scaffolds for stem cell growth, the scaffolds having preformed gradients of therapeutic compounds. The scaffold materials, according to Campbell et al, fall within the category of “bio-inks”. Such “bio-inks” are suitable for use with the compositions and methods of the present invention, see [0139]. Dvir et al. teaches use of copper sulphate in culture medium, see [0211].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized copper sulphate as salt/buffer into the formulation of Hwang et al. or Kang et al. for the use of culture medium (salts/bases) motivated by the teachings of Dvir et al. and Campbell et al. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SNIGDHA MAEWALL whose telephone number is (571)272-6197. The examiner can normally be reached Monday thru Friday; 8:30 AM to 5PM.
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
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