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 status
Claims 1-8 are pending.
Claims 1-8 are under examination.
Claim interpretation
The independent claim (claim 1) is drawn a to manufacturing device for generation of artificial skin. However, the dependent claims are drawn to cell culture and iPSCs differentiation, which do not further limit the structure of the device. Since the invention as claimed is directed to the device, claims 2-8 are examined with respect to the structure of the claimed device.
Regarding claim 6, the acronym dkSFM is not defined in the specification. In view of prior art and the context of the claimed invention, the said acronym is interpreted as ‘defined keratinocyte serum-free medium.
Claim objections
Regarding claim 1, the acronym iPSCs is not written out at the first recitation. Therefore, the claim is objected to, and it is required that the term be fully written out in the first recitation.
Regarding claim 6, the acronym ‘dkSFM’ is not defined in the specification. Therefore, the claim is objected to (see claim interpretation). It is required that the term be fully written out in the first recitation, and the use of acronym after the first recitation is acceptable.
Appropriate corrections are 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 3 and 6 are 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 3 recites the limitation "the fibroblasts" in line 2 of claim 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the keratinocytes" in line 2 of claim 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 and 6 recite, ‘fibroblasts are differentiated by adding..’ in claim 3 and ‘keratinocytes are differentiated by adding..’ in claim 6, respectively. Fibroblasts and keratinocytes are terminally differentiated cells and cannot be further differentiated. Therefore, the claims are indefinite for failing to particularly point out and distinctly claim the subject matter.
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.
Claim 1 is rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Albanna, Mohammed, et al., Scientific reports 9.1 (2019): 1856.
Regarding claim 1, Albanna teaches a manufacturing device for artificial skin generation for accelerated wound healing. The device comprises a 3D printer, with a print-head capable of moving in XYZ directions and nozzles, with each nozzle connecting to separate cartridges, wherein one cartridge is loaded with fibroblasts and the other with keratocytes. The two cartridges, each containing fibroblasts and keratinocytes separately in matrix solutions are interpreted as the fibroblast and keratinocyte liquid containers as recited in claim 1.
Two nozzles are shown in fig. 1B (shown below), each nozzle is connected to an individual cartridge, containing either fibroblasts or keratinocytes, and also to the print head, through which the material is delivered.
Fig.1
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(The above figure is part of the fig.1 taken from Albanna et al. )
The upper parts of the nozzles ( fig. 1B) including the tubing that’s connected to cartridges are interpreted as the first and second transfer pipes of the claim limitations. The lower ends of the nozzles are connected to the print head interpreted as the injection device (fig. 1 A-B) of the claim limitations (abstract, fig.1, results , skin bioprinter design and construction, page 2 and 3).
The print head (interpreted as the injection device) is connected the upper parts of the nozzles with tubing connecting to cartridges (interpreted as the first and the second transfer pipes) (fig.1 A-B). The last part of claim 1 states that the injection device is connected to the transfer pipes with nozzles. I am not sure if you addressed this or if your reference teaches this. It is always better to map to the reference using language from the claims.
Albanna also teaches a stage that can be moved in X,Y,Z directions and is shown in fig.1 (page 3) where a patient or a specimen to be treated with a skin graft is mounted which is interpreted as the flat plate that can independently be transferred on X, Y and Z axis in the claim limitations.
The claim 1 is drawn to a manufacturing device of artificial skin. The preamble recites an intended use of using cells differentiated from iPSCs. The limitation pertaining to the intended use of the device is not given patentable weight. (see claim interpretation section).
Therefore, the reference anticipates the claimed subject matter.
The dependent claims 2-8 are examined with respect to the structure of the device as noted above in the claim interpretation section. Therefore, claims 2-8 are included in the rejection.
Conclusion.
No claim is allowed.
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/HASHANTHI KOMITIGE ABEYRATNE-PERERA/ Examiner, Art Unit 1632
/PETER PARAS JR/ Supervisory Patent Examiner, Art Unit 1632
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