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 .
Election/Restrictions
Applicant’s election without traverse of Invention I, claims 1-7, in the reply filed on 12/08/2025 is acknowledged.
Claims 8-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/08/2025.
Status of the Claims
Claims 1-11 are currently pending.
Claims 8-11 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 1-7 have been considered on the merits.
Claim Objections
Claim 2 is objected to because of the following informalities: the phrase “wherein the culture colloid includes a group consisting of” and needs to be corrected to “wherein the cell culture colloid is selected from a group consisting of”. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: the phrase “wherein the cell growth promoter includes a group consisting of” and needs to be corrected to “wherein the cell growth promoter is selected from a group consisting of”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation “wherein the crosslinking treatment is carried out by mixing 5 vol% to 25 vol% of calcium chloride into the cell culture colloid”, which is indefinite. This phrase renders the claim unclear because 5 vol% to 25 vol% of calcium chloride is not a defined concentration of calcium chloride which can be calculated based on the disclosure. For example, a calcium chloride solution with 5 vol% requires a liquid form of calcium chloride be diluted by adding 5 ml of calcium chloride to 95 ml of diluent. However, calcium chloride is not available as a 100% calcium chloride solution because it is a solid at room temperature, therefore technically any liquid solution of calcium chloride can be used to produce a 5 vol% solution of calcium chloride. Additionally, the instant specification does not define a starting concentration of the calcium chloride solution to be diluted to a between 5-25 vol% solution. The specification states “In the present disclosure, the crosslinking agent can be calcium chloride, barium chloride, zinc chloride, calcium carbonate, calcium sulfate, or calcium lactate. In one preferred embodiment, the crosslinking agent is 5 vol% to 25 vol% of a calcium chloride solution, but the present disclosure is not limited thereto” ([0034]). Calcium chloride and CaCl2 do not appear to be mentioned anywhere else in the specification. Thus, any starting concentration of calcium chloride solution is capable of being diluted to a 5-25 vol% solution. Therefore, the claimed range of 5 vol% to 25 vol% of calcium chloride is met by any concentration of calcium chloride in the art. Appropriate clarification is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Voytik-Harbin et al (US20120094376 A1), referred to as Harbin.
Claim Interpretation: Claim 6 contains a limitation of a concentration of between 5-25 vol% of calcium chloride, which is not capable of being clearly defined due to the nature of vol% calculations. This is explained in more detail in the 112(b) rejection presented above. For the sake of compact prosecution claim 6 is being interpreted to be met by any concentration of calcium chloride in the art.
Regarding claim 1, Harbin teaches a method of a 3D culture through providing a culture colloid mixed with cells ([0092]), performing a crosslinking treatment to the culture colloid mixed with cells thereby embedding and suspending the cells in the crosslinked colloid ([0098]), and then performing cell culture with the embedded cells in the crosslinked colloid ([0115]). Harbin teaches that the culture colloid contains collagen ([0001]) and hyaluronic acid ([0112]) as required by claim 2. Harbin teaches that the culture colloid further comprises a cell growth promoter including collagen ([0001]), extracellular matrix ([0024]), Fibronectin, laminin, and/or growth factors ([0111]) as required by claims 3 and 4. Harbin teaches that the cells are mammalian or human cells ([0120]) and can be fibroblasts, endothelial cells, epithelial cells ([0092]), or mesenchymal stem cells ([0213]) as required by claim 5. Harbin teaches that the crosslinking is completed using a calcium chloride solution of about 0.4 to 2.0 mM as required by claim 6. Harbin also teaches that the modulus of the culture colloid can be from 0.5 to 40 kPa, which encompasses the entire claimed range of 1000-5000 Pa as required by claim 7 ([0010]).
Thus, the claims are anticipated by Harbin.
Conclusion
No claims are allowed.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632