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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
Applicant’s amendment has been considered and entered for the record.
Claim Interpretation
It should be noted that within the quoted sections of the claims that any changes to the instant claims is only for the purposes of mapping the listed limitation with the prior art of record and is not intended to indicate any modification of the instant claim language on the part of the examiner.
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.
Claims 1-9 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.
For claim 1, it is unclear, in light of the specification, what applicant means by the term “channelize”. The standard definition for this term is to either provide a channel or to channel and that is how this term will be interpreted for purposes of examination. If this is what applicant meant by the term, it is requested that clarification be provided in the response to this Office Action.
Claims 2-9 are rejected under 35 U.S.C. 112b since the claims depend upon and incorporate all the limitations of the instant claim 1.
Clarification and appropriate corrective action 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.
Claims 1-6 and 9 are rejected under 35 U.S.C. 102a1 as being anticipated by Kamm et al. (US 2014/0057311 A1 – hereafter ‘311).
‘311 discloses a microfluidic device that is used for 3D bioassays (Abstract) that includes the following limitations for claim 1:
“A microfluidic device for inducing bidirectional oscillatory shear stress on biological cells”: ‘311 discloses a microfluidic device that is used for a 3D bioassay ([0052]) that is fully capable of being used for inducing bidirectional oscillatory shear stress on biological cells. It should be noted that preamble statements reciting the purpose or intended use of the invention rather than any distinct definition of any of the claimed invention's limitations is not considered to structurally define the claimed invention over the prior art. See also MPEP 2111.02 II and 2114.
“a coverslip defined with a flow surface adapted to receive a plurality of biological cells”: ‘311 discloses a glass slide (Fig. 24; [0049]; i.e. the coverslip) that has a surface that can receive biological cells.
“a cover member disposed on the coverslip, wherein the cover member and the coverslip define a chamber for receiving fluid”: ‘311 discloses a cover (PDMS device; Fig. 24; [0049]) that forms the ceiling and walls of the device. This element is being interpreted as the cover member of the instant application.
“the cover member comprises”: ‘311 discloses that the cover has the elements listed below.
“a first inlet section defined at a portion of the cover member, wherein the first inlet section is configured to selectively receive and channelize fluid at a first predetermined velocity into the chamber”: ‘311 discloses a first inlet (Fig. 24; [0118]) that has a first inlet section and a channel and is fully capable of selectively receiving and channelizing a fluid.
“a second inlet section of eh cover member away from the first inlet section, wherein the second inlet section is configured to selectively receive and channelize fluid at a second predetermined velocity into the chamber”: ‘311 discloses a second inlet (Fig. 24; [0118]) that has a channel and is fully capable of selectively receiving and channelizing a fluid.
“wherein, fluid channelized at the first predetermined velocity and the second predetermined velocity into the chamber creates a predefined oscillatory bi-direction flow pattern to induce predefined wall shear stress on the plurality of biological cells.”: The microfluidic device of ‘311 is fully capable of channelizing the fluids at a predetermined velocity and create an oscillatory bi-direction flow pattern that induces wall shear stress.
For claim 2, that the cells are cultured on the glass slide ([0049]).
For claim 3, ‘311 discloses an outlet section that is opposite the first and second outlet ([0118]); Fig. 24; Fig. 26) that is configured to dispense/remove fluid from the system.
For claim 4, ‘311 discloses a reservoir connected to the outlet ([0116]).
For claim 5, ‘311 discloses that the first inlet, the second inlet and outlet are in a spaced apart, angled configuration (Fig. 24; Fig. 26; [0049]; [0118]).
For claim 6, ‘311 discloses the slide or coverslip is made of glass ([0049]; Fig. 24) that is a transparent material and allows for the microscopic observation of the cells.
For claim , ‘311 discloses a microscope that receives the chip and optically observes the cells (([0164]).
Therefore, ‘311 meets the limitations of claims 1-6 and 9.
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.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kamm et al. (US 2014/0057311 A1 – hereafter ‘311) in view of Szita et al. (US 2021/0252509 A1 – hereafter ‘509).
For claim 7, ‘311 (Kamm) does not explicitly disclose placing the microfluidic device into a frame.
‘509 (Szita) discloses a multi-functional dual mode microfluidic device (Abstract) that for claim 7 includes using a frame (frame 7; Fig. 1A) for holding a microfluidic chip (chip 5; [0071]). This allows the chip to be encapsulated and allows for conduits to be connected to the chip ([0108]).
Therefore, it would have been obvious to one of ordinary skill in the art the time of the earliest effective filing date to include the frame of ‘509 within ‘311 in order to hold and support the chip. The suggestion for doing so at the time would have been in order to be able to hold different microscope slide formats ([0207]).
‘311 differs from the instant claim 8.
For claim 8, ‘509 discloses that the frame has a cavity for holding the slide and includes a top plate and bottom frame (plate 3; frame 7; Fig. 1A; [0071]).
Therefore, it would have been obvious to one of ordinary skill in the art the time of the earliest effective filing date to include the frame of ‘509 within ‘311 in order to hold and support the chip. The suggestion for doing so at the time would have been in order to be able to hold different microscope slide formats ([0207]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Demirci et al. (US 2014/0248656 A1) discloses a device for sorting motile cells in a microfluidic device.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 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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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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