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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/10/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by 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 7-8 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.
Regarding claim 7, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 8 would be rejected under 35 U.S.C. 112b since the claim depends upon and incorporates all the limitations of claim 7.
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 1-3, 7 and 8 are rejected under 35 U.S.C. 102a1 as being anticipated by Kang et al. (US 2023/0332079 A1 – hereafter ‘079).
‘079 discloses a biomimetic chip (Abstract) that includes the following limitations for claim 1:
“A microfluidic in vitro osteochondral device”: ‘079 discloses a biomimetic chip (chip 10; Fig. 1; [0051]) that is being interpreted as the microfluidic device of the instant application.
“a synovial chamber”: ‘079 discloses a first chamber (channel 210; Fig. 2; [0055]) that is being interpreted as a synovial chamber.
“a cartilage chamber adjacent to and porously coupled with the synovial chamber”: ‘079 discloses a second culture chamber (channel 310; Fig. 2; [0062]) that is connected to the first chamber through a porous wall (Fig. 2) and is being interpreted as the cartilage chamber.
“a bone chamber adjacent to and porously coupled with the cartilage chamber”: ‘079 discloses a first medium chamber (channel 410; Fig. 2; [0068]) that is being interpreted as the bone chamber of the instant application and is connected to the second culture chamber by a porous wall (Fig. 2).
“a vasculature circulation chamber adjacent to and porously coupled with the bone chamber”: ‘079 discloses a third culture chamber (channel 610; Fig. 2; [0092]) that is connected to the medium chamber by a porous wall (Fig. 2) and is being interpreted as the vasculature circulation chamber of the instant application.
“wherein a first porous wall is positioned between the synovial chamber and the cartilage chamber, a second porous wall is positioned between the cartilage chamber and the bone chamber, and a third porous wall is positioned between the bone chamber and the vasculature circulation chamber”: ‘079 discloses a porous wall positioned between each of the chambers (Fig. 2).
“which is configured as a microfluidic in vitro model of an in vivo osteochondral region”: The device is fully capable as operating as a microfluidic in vitro model of an in vivo osteochondral region.
For claim 2, the synovial chamber of ‘079 is fully capable of operating as a fluid reservoir and can be connected to a pump and media reservoirs. The vasculature chamber of ‘079 is being interpreted as a physiological microvasculature structure and is fully capable of being connected to a pump and a reservoir. For the cartilage chamber of ‘079 is being interpreted as a physiological cartilage region and is fully capable of being configured to a pump and reservoir. The bone chamber of ‘079 is being interpreted as a physiological bone region and is fully capable of being connected to a pump and reservoir.
For claim 3, ‘079 teaches the order of Synovial chamber, a first porous wall, the cartilage chamber, the second porous wall, the bone chamber, the third porous wall and the vasculature chamber (Fig. 2).
Claims 7 and 8 are drawn to the material operated on by the apparatus which does not structurally define the claimed invention over the prior art (see MPEP §2115).
Therefore, ’079 meets the limitations of claims 1, 2, 3, 7 and 8.
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 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kang et al. (US 2023/0332079 A1 – hereafter ‘079) in view of Gottardi et al. (US 2019/0076840 A1 – hereafter ‘840).
‘079 (Kang) differs from claims 9 and 10 regarding a pump and a computer with a camera to monitor the system.
‘840 (Gottardi) discloses for claim 9 a bioreactor system (Abstract) that for claim 9 includes a syringe pump ([0157]) that is used to supply medium and cells to the device.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the earliest effective filing date to include the pump of ‘840 within ‘079 in order to supply medium to the microfluidic device. The suggestion for doing so at the time would have been in order to provide perfusion fluid to each chamber ([0176]).
For claim 10, ‘840 discloses using a computer ([0285]) and a camera ([0142]) for observing the device.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the earliest effective filing date to include the computer and camera of ‘840 within ‘079 control the system and view the cells ([0180]). See also MPEP §2144.04 III.
Allowable Subject Matter
Claims 4-6 and 11-31 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: for claim 4, the prior art fails to teach or fairly suggest a microfluidic in vitro OC device that includes, in order, where the synovial chamber having a width in a range from about 50 microns to about 2000 microns; the first porous wall having a width in a range from about 20 microns to about 100 microns; the cartilage chamber having a width in a range from about 50 microns to about 2000 microns; the second porous wall having a width in a range from about 20 microns to about 100 microns; the bone chamber having a width in a range from about 50 microns to about 2000 microns; the third porous wall having a width in a range from about 20 microns to about 100 microns; the vasculature circulation chamber having a width in a range from about 50 microns to about 2000 microns; and the synovial chamber, cartilage chamber, bone chamber, and vasculature circulation chamber can have a height that ranges from about 10 microns to about 1000 microns.
Claims 5 and6 would be allowable for the same reasons as claim 4.
For claim 11, the prior art fails to teach or fairly suggest a microfluidic in vitro OCE system that includes a computing system where the computing system includes a non-transitory memory device having instructions to obtain data from the at least one camera device and determine at least one trans-OC transport barrier property of the microfluidic in vitro OC device or at least one trans-OC transport property of a test agent, wherein the trans-OC transport barrier property is a measurement of inhibition of transport of an agent across the cartilage chamber and/or bone chamber, and the trans-OC transport property of a test agent is a measurement of traversal of the test agent across the cartilage chamber and/or bone chamber.
For claim 12, the prior art fails to teach or fairly suggest a method of studying an osteochondral environment that provides the microfluidic in vitro device of claim 1 and includes the following elements: the cartilage chamber includes chondrocyte cells, chondroblast cells, and/or chondroblast cells differentiated from human mesenchymal stem cells; the bone chamber includes osteoblast cells, osteoclast cells, and/or osteocyte cells differentiated from human mesenchymal stem cells; and the vasculature circulation chamber includes vascular endothelial cells; measuring a first condition of the microfluidic in vitro OC device at a first time point; measuring a second condition of the in vitro OC device at a subsequent time point; and determining a change in condition of the in vitro OC device from the first condition to the second condition.
Claims 13 and 14 would be allowable for the same reasons as claim 12.
For claim 15, the prior art fails to teach or fairly suggest a method of studying transport of a test agent across a OC that provides the microfluidic in vitro device of claim 1 and the device includes the following elements: the cartilage chamber includes chondrocyte cells, chondroblast cells, and/or chondroblast cells; the bone chamber includes osteoblast cells, osteoclast cells, and/or osteocyte cells; and the vasculature circulation chamber includes vascular endothelial cells; providing a test agent to an input chamber selected from the synovial chamber, cartilage chamber, bone chamber, or vasculature circulation chamber; and monitoring transport of the test agent across at least one of the cartilage chamber or the bone chamber.
For claim 23, the prior art fails to teach or fairly suggest a method differentiating cells that provides the microfluidic in vitro device of claim 1 and the device includes the following steps: introducing first human mesenchymal stem cell into the cartilage chamber; introducing a chondrogenic differentiation medium into the cartilage chamber with the first human mesenchymal stem cells; incubating the first human mesenchymal stem cells with the chondrogenic differentiation medium sufficiently to differentiate into at least one of chondrocyte cells, chondroblast cells, and/or chondroblast cells; incubating second human mesenchymal stem cells with osteogenic differentiation medium sufficiently to differentiate into at least one of osteoblast cells, osteoclast cells, and/or osteocyte cells; obtaining the differentiated at least one of osteoblast cells, osteoclast cells, and/or osteocyte cells in the bone chamber; and introducing vascular endothelial cells into the vasculature chamber.
The closest prior art is by Kang et al. (US 2023/0332079 A1) that discloses a biomimetic chip (chip 10; Fig. 1; [0051]) with multiple culture channels, but does not teach or fairly suggest the limitations of claims 4-6, 11 and 12-31.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lin et al. (US 2019/0276784 A1) that discloses a bioreactor device that mimics mammalian joints.
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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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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