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 .
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.
Information Disclosure Statement
The information disclosure statements dated 8/8/2023 and 11/7/2025 have been considered and made of record.
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 1, 3, 6, 11-14 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mathur et al. (US 10,233,415) (Attached PTO-892).
With respect to claim 1, the reference of Mathur et al. discloses:
An organ-on-a-chip (microfluidic chip)(1)(Fig. 17) for reproducing a biological process between a cell mass and a blood vessel, comprising:
a first channel (media channel)(3);
a second channel (cell culture channel)(2); and
a third channel group (microchannels)(4),
wherein the first channel is an introduction channel for introducing vascular endothelial cells for forming a blood vessel model on an inner wall of the first channel through cell culture (Note: The media channel (3) is structurally capable of having vascular endothelial cells introduced therein),
the second channel is an introduction channel for introducing a sample containing a cell mass from an upstream side toward a downstream side, and includes a trap portion (weir)(5) for trapping the cell mass (Note: The weir (5) is structurally capable of trapping a cell mass) and located between the upstream side and the downstream side inside the second channel, and
the third channel group includes a plurality of third channels (microchannels)(4), and the third channels are channels that communicate between the first channel and the second channel (Fig. 17).
With respect to claim 3, the reference of Mathur et al. discloses that in a direction perpendicular to an axial direction of the second channel (2) (Fig. 20), a cross-sectional area of an inner space of the trap portion is smaller than the minimum cross-sectional area of cross sections of the cell mass passing through the center of the cell mass.
With respect to claim 6, the reference of Mathur et al. discloses that in a direction perpendicular to an axial direction of the second channel (2), an inner space of the trap portion has a quadrilateral cross section, and lengths of at least a pair of sides of two pairs of opposite sides of the cross section are smaller than a diameter of the cell mass (Fig. 20).
With respect to claims 11 and 12, the reference of Mathur et al. discloses that the third channel group (4) is disposed upstream (0 µm)(claim 12) of the trap portion in the second channel (2) (Fig. 17).
With respect to claims 13 and 14, the reference of Mathur et al. discloses that in a direction perpendicular to an axial direction of the first channel (3), when an inner space of the first channel has a quadrilateral cross section, the cross section has a width and a height of 100 to 500 µm (Col. 5, lines 52-67) (Claim 14). With respect to claim 13, since the reference of Mathur et al. meets the limitations of claim 14, it is also considered to meet the limitations of claim 13 since this also could be the outer circumference of a blood vessel which can vary.
With respect to claim 17, the reference of Mathur et al. discloses that the chip can include a pair of substrates,
wherein one of the substrates is placed on the other substrate,
an opposed surface of the one substrate is provided with recessed portions serving as inner spaces of the first channel, the second channel, and the third channel group, and
the recessed portions on the opposed surface of the one substrate and an opposed surface of the other substrate form the first channel, the second channel, and the third channel group (Col. 9, lines 55-64).
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.
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 15 is rejected under 35 U.S.C. 103 as being unpatentable over Mathur et al. (US 10,233,415) (Attached PTO-892).
The reference of Mathur et al. has been discussed above with respect to claim 1.
While the reference of Mathur et al. discloses that one or more surfaces of the device can be contacted with a coating layer (fibronectin) with an affinity for vascular endothelial cells (Col. 9, line 65, to Col. 10, line 10), claim 15 differs by specifying that the coating layer is provided on the inner wall of the first channel.
However, in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to provide the first channel (3) of the reference of Mathur et al. with a coating layer to promote cell adhesion for the known and expected result of allowing a co-culture of cells to be performed within the device between the first channel (3) and the second channel (2) and allowing the interaction of the cells to be monitored.
Claims 2, 4, 5, 7-10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Mathur et al. (US 10,233,415) (Attached PTO-892) in view of Altiok et al. (US 2014/0127733) (Attached PTO-892).
The reference of Mathur et al. has been discussed above with respect to claims 1 and 3.
Claim 2 differs by reciting that the trap portion of the chip traps a cell mass and allows single cells to pass through.
The reference of Altiok et al. discloses that it is known in the art to culture and study biological samples (tumor or tissue samples between about 100 µm and 500 µm in diameter) (¶[0052]) within a channel (101) wherein the channel includes a trap portion dimensioned to trap the biological sample and would allow single cells to pass through.
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to modify the reference of Mathur et al. to allow the trapping of biological samples as suggested by the reference of Altiok et al. for the known and expected result of allowing the culture of tumor or tissue samples and allowing for the evaluation of drugs using the system of the reference of Mathur et al. The structure resulting from the combination of the claims would result in a chip with a trap portion in the second channel which traps a cell mass and allows single cells to pass through.
With respect to claims 4, modification of the trap portion (weir)(5) of Mathur et al. to allow the trapping of a cell mass and allowing single cells to pass would meet the limitations of claims 4.
With respect to claim 5, modification of the chip device of Mathur et al. to accommodate a biological sample as suggested by the reference of Altiok et al. would result in trap portion dimensions and upstream portions of the second channel with dimensions within the ranges required of claim 5.
With respect to claims 7-10, the reference of Altiok et al. discloses the use of columnar bodies (102) as trap portions within a channel (101).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to employ columnar bodies in place of the weir structure of Mathur et al. for the known and expected result of providing an alternative means recognized in the art to achieve the same result, trapping biological samples within the channel. In the absence of a showing of unexpected results, it would have been well within the purview of one having ordinary skill in the art to determine the optimal dimensions of the columnar bodies and positions through routine experimentation while maintaining the efficiency of the chip device.
With respect to claim 16, in view of the modification of the chip device to accommodate biological samples as suggested by the reference of Altiok et al. and in the absence of a showing of unexpected results, it would have been well within the purview of one having ordinary skill in the art to determine the optimal dimensions of the third channels through routine experimentation while maintaining the efficiency of the chip device.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Mathur et al. (US 10,233,415) (Attached PTO-892) in view of Noda et al. (WO 2006/003790 and corresponding English language machine translation) (Attached PTO-892).
The reference of Mathur et al. has been discussed above with respect to claim 1.
While the reference of Mathur et al. discloses construction of the chip device using a pair of substrates, wherein one of the substrates is placed on the other substrate, an opposed surface of the one substrate is provided with recessed portions serving as inner spaces of the first channel, the second channel, and the third channel group, and the recessed portions on the opposed surface of the one substrate and an opposed surface of the other substrate form the first channel, the second channel, and the third channel group (Col. 9, lines 55-64).
Claim 18 differs by reciting opposing surface of the two substrates include recesses for forming channels.
The reference of Noda et al. discloses that it is known in the art to form channels using substrates wherein the channel can be formed in a recess in a single substrate (Fig. 2) or by using two channels with matching recesses (Fig. 3(a)) (page 7, ¶[0037], of the machine translation).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to employ the shelling technique disclosed by the reference of Noda et al. to form the channels of the reference of Mathur et al. for the known and expected result of using an alternative technique recognized in the art for manufacture of the chip device with channels.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The reference of Forbes et al. (US 2011/0081664) is cited as prior art that pertains to channel structures for trapping tumors.
The reference of Yu et al. (US 2008/0233607) is cited as prior art that pertains to a cell culture channel device that includes a cell trap portion.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H BEISNER whose telephone number is (571)272-1269. The examiner can normally be reached on Mon-Fri from 8am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL A MARCHESCHI, can be reached at telephone number (571)272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William H. Beisner/
Primary Examiner
Art Unit 1799
WHB
Prosecution Insights