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 .
Specification
The disclosure is objected to because of the following informalities: the status of U.S Patent Application No. 16/259,399 needs to be updated.
Appropriate correction 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.
Claim(s) 1-9, 11,12 and 14-16 are rejected under 35 U.S.C. 102a1 as being anticipated by Kosnik et al. (US 2006/0258004 A1 – hereafter ‘004).
‘004 discloses a system that uses a scaffold (Abstract) that includes the following limitations for claim 1:
“A device”: ‘004 discloses a vessel bio-chamber (Fig. 1; [0040]) that is being interpreted as the device of the instant application.
“a longitudinal channel for tissue cultivation”: ‘004 discloses an interior space (space 3; Fig. 1) that is being interpreted as the longitudinal channel of the instant application ([0040]).
“a perfusable tube scaffold suspended longitudinally in the channel for cultivating a tissue structure.”: ‘004 discloses a graft scaffold (scaffold 5; Fig. 1; [0040]) that is disposed within the interior space, i.e. channel. This scaffold is a tubular scaffold ([0029]).
For claim 2, ‘004 discloses that the scaffold has a lumen structure ([0043]; Fig. 1).
For claim 3, ‘004 discloses that the scaffold is connected to a perfusion system ([0013]) that would have a fluid reservoir and discloses applying a negative pressure at the distal EC side ([0043]).
For claim 4, ‘004 discloses that the scaffold can be made from a biological material such as collagen ([0031]).
For claim 5, the collagen scaffold of ‘004 would be biodegradable ([0031]).
For claim 6, the collagen scaffold of ‘004 would be substantially free of PDMS ([0031]).
For claims 7 and 8, the graft of ‘004 is fully capable of being used as a bypass graft and is implantable ([0010]).
‘004 discloses the following limitations for claim 9:
“A method for cultivating tissues”: ‘004 discloses a method for cultivating a tissue graft ([0010]).
“providing a device including”: ‘004 discloses providing a vessel bio-chamber (Fig. 1; [0040]) that is being interpreted as the device of the instant application.
“a longitudinal channel for tissue cultivation”: ‘004 discloses an interior space (space 3; Fig. 1) that is being interpreted as the longitudinal channel of the instant application ([0040]).
“a perfusable tube scaffold suspended longitudinally in the channel for cultivating a tissue structure”: ‘004 discloses a graft scaffold (scaffold 5; Fig. 1; [0040]) that is disposed within the interior space, i.e. channel. This scaffold is a tubular scaffold ([0029]).
“introducing seed cells into the channel of the device”: ‘004 discloses introducing seed cells into the channel ([0010]).
“culturing the seed cells in the channel.”: ‘004 discloses culturing cells within the channel ([0029]).
For claim 11, ‘004 discloses culturing vascular cells ([0019]).
For claim 12, ‘004 discloses culturing smooth muscle cells ([0027]).
For claim 14, ‘004 discloses culturing liver cells ([0025]; i.e. hepatocytes).
For claim 15, ‘004 discloses that the grafts are implantable in a patient ([0024]).
For claim 16, ‘004 discloses that the graft is for a vascular tissue graft ([0010]) and therefore is for direct anastomosis in a patient.
Therefore, ‘004 meets the limitations of claims 1-9, 11, 12 and 14-16.
Claim(s) 17, 18 and 20 are rejected under 35 U.S.C. 102a1 as being anticipated by Vacanti et al. (WO 03/082145 A2 – hereafter ‘145).
‘145 discloses a scaffold (Abstract) that includes the following limitations for claim 17:
“A device”: ‘145 discloses a device for culturing tissue (page 26, lines 7-14; Fig. 6; Fig. 8A).
“a chamber for tissue cultivation and a scaffold having a branching channel network for cultivating a tissue structure.”: ‘145 discloses two molds (molds 32 &30) that forms an enclosure (enclosure 34; Fig. 8A) that includes the scaffold to culture a tissue where the scaffold is serially branched to form channels (page 26, lines 7-17 & 16-22).
For claim 18, ‘145 discloses that the scaffold has a plurality of channels and struts (Fig. 11; page 34, lines 14-21).
For claim 20, ‘145 discloses to provide preexisting vasculature systems (page 5 lines 14-20) where this is being interpreted as mimicking a vasculature system in a human.
Therefore, ‘145 meets the limitations of claims 17, 18 and 20.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 10, 13 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kosnik et al. (US 2006/0258004 A1 – hereafter ‘004) in view of Chen et al. (WO 2013/056019 A1 – hereafter ‘019).
‘004 differs from the instant claim 10 regarding the use of electrical stimulation.
‘’019 discloses a method for generating microtissue (page 12 lines 4-12) that for claim 10 includes the stem of using electrical stimulation on the cells in order to achieve better compaction of the matrix by the cells (page 37 lines 1-3).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the step of using electrical stimulation as suggested by ‘019 within ‘004 in order to have faster alignment of cells (page 37, line 2). The suggestion for doing so at the time would have been in order to improve both the structure and function of the tissue (page 27 lines 5-8).
For claim 13, ‘014 does not specify using neurons.
For claim 13, ‘019 discloses culturing neuronal cells (page 4 lines 18-23).
Therefore, it would have been obvious to one of ordinary skill in the art to employ the neuronal cells of ‘019 within ‘004 in order to create a network of neurons. The suggestion for doing so at the time would have been on order to generate microtissue (page 4 lines 1-2).
For claim 19, ‘004 does not explicitly disclose supports or protrusions that support the scaffold.
‘019 discloses for claim 19 using microcantilevers for supporting the scaffold (page4 lines 4-6). These cantilevers anchor the matrix (page 5 lines 12-14).
Therefore, it would have been obvious to one of ordinary skill of the art at the time of filing to include the cantilevers of ‘019 within ‘004 in order to raise the scaffold of the bottom of the well or channel. The suggestion for doing so at the time would have been in order to constrain the contraction of the matrix (page 5 lines 12-14).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rowley et al. (US 2004/0063206 A1) discloses a three-dimensional scaffold with interconnected pore structures.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799