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 Objections
Claim 105 is objected to because of the following informalities: method steps a) - e) are disclosed, but step b) is not present or claimed. Step b) text should be added, or deleted to create steps a) – c) instead. 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.
(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(s) 105-114 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Huh et al. (US20230078827A1).
Regarding Claim 105, Huh et al. teaches a method (See the Abstract, the microphysiological platform 100, and the Claim(s) 1-27, 38, and 53 in [0002]-[0006], [0027]-[0179] in Fig. 1-20), comprising:
a) providing a microfluidic device (See the array of microphysiological devices 130, i.e. microfluidic devices, in [0029] in Fig. 1) comprising at least one microfluidic channel comprising attached cells (See how each microphysiological device 130 in microphysiological platform 100 can be configured to contain, and can include, any one or more of tissues, cells, bacteria, viruses, other living entities, biological scaffolds, or explanted tissues, and can replicate the structure and function of an organ, or part thereof on a substrate 101 in [0068]-[0700] in Fig. 1; Also, see how the tissue chambers 137 are interposed with channels 136 in [0071 in Fig. 5A-C);
c) releasing a plurality of exosomes from said attached cells (See the secretion of complex biological entities, including extracellular vesicles, exosomes, viral particles, constituents of an extracellular matrix, polymers, enzymes, nucleic acids, peptides, or proteins from the biological entities in a microphysiological device into the surrounding fluid solution in [0090] in Fig. 18);
e) flowing said released plurality of exosomes out of said microfluidic channel (See the fluid output 164 in [0029] in Fig. 1 and 18).
Regarding Claim(s) 106-107, Huh et al. teaches the method limitations of claim 105.
Huh et al. further teaches a method (See the Abstract, the microphysiological platform 100, and the Claim(s) 1-27, 38, and 53 in [0002]-[0006], [0027]-[0179] in Fig. 1-20), wherein said cells are cultured with fluid under flow (See how the fluidic synthesizer 110, the fluidic addressing system 120, and the fluid handler 195 controls fluid flow to the cells in [0029]-[0042] in Fig. 1);
wherein said microfluidic channel is connected to an outlet port and said exosomes flow out of said microfluidic channel via said outlet port as output exosomes (See the fluid output 164 in [0029], [0090] in Fig. 1 and 18 and claim 6).
Regarding Claim 108, Huh et al. teaches the method limitations of claim 107.
Huh et al. further teaches a method (See the Abstract, the microphysiological platform 100, and the Claim(s) 1-27, 38, and 53 in [0002]-[0006], [0027]-[0179] in Fig. 1-20), further comprising collecting said output exosomes (See the fluid output 164 in [0029], [0037], [0090] in Fig. 1 and 18 and in claim(s) 6 and 17).
Regarding Claim 109, Huh et al. teaches the method limitations of claim 108.
Huh et al. further teaches a method (See the Abstract, the microphysiological platform 100, and the Claim(s) 1-27, 38, and 53 in [0002]-[0006], [0027]-[0179] in Fig. 1-20), further comprising adding the exosomes collected as output from a microfluidic channel to another microfluidic channel as input (See the fluid output 164 in [0029], [0037], [0060], [0090] in Fig. 1, 4-5A and 18 and in claim 15, 19, and 24).
Regarding Claim 110, Huh et al. teaches a method (See the Abstract, the microphysiological platform 100, and the Claim(s) 1-27, 38, and 53 in [0002]-[0006], [0027]-[0179] in Fig. 1-20), comprising:
a) a first microfluidic device (See the array of microphysiological devices 130, i.e. microfluidic devices, in [0029] in Fig. 1) said microfluidic channel comprising a first cell type (See how each microphysiological device 130 in microphysiological platform 100 can be configured to contain, and can include, any one or more of tissues, cells, bacteria, viruses, other living entities, biological scaffolds, or explanted tissues, and can replicate the structure and function of an organ, or part thereof on a substrate 101 in [0034], [0068]-[0700] in Fig. 1; Also, see how the tissue chambers 137 are interposed with channels 136 in [0071] in Fig. 5A-C);
b) a plurality of extracellular vesicles, wherein said extracellular vesicles were obtained from a second microfluidic device comprising cultured cells of a second cell type (See the secretion of complex biological entities, including extracellular vesicles, exosomes, viral particles, constituents of an extracellular matrix, polymers, enzymes, nucleic acids, peptides, or proteins from the biological entities in a microphysiological device into the surrounding fluid solution in [0090] in Fig. 18; Also, see the fluid output 164 and multiple devices in [0029], [0037], [0060], [0090] in Fig. 1, 4-5A and 18 and in claim 15, 19, and 24);
c) introducing said extracellular vesicles into said microfluidic channel under conditions wherein said first cells are exposed to said extracellular vesicles so as to create exposed cells (See in [0090], [0122]-[0148], [0168]-[0179] and claim 8).
Regarding Claim(s) 111-112, Huh et al. teaches the method limitations of claim 110.
Huh et al. further teaches a method (See the Abstract, the microphysiological platform 100, and the Claim(s) 1-27, 38, and 53 in [0002]-[0006], [0027]-[0179] in Fig. 1-20), further comprising d) detecting the uptake of one or more extracellular vesicles in one or more exposed cells (See how the imager 182 can be used to detect a type of cell or cell culture in the microphysiological devices 130 based on how light is absorbed, reflected, or scattered from the microphysiological devices 130 a in [0046], [0900], [0153]-[0154] in Fig. 1-20 and claim(s) 12, 15-16, and 26);
further comprises flowing media at a flow rate through said microfluidic channel prior to step c) (See how the fluidic synthesizer 110, the fluidic addressing system 120, and the fluid handler 195 controls fluid flow to the cells in [0029]-[0042] in Fig. 1).
Regarding Claim 113, Huh et al. teaches the method limitations of claim 112.
Huh et al. further teaches a method (See the Abstract, the microphysiological platform 100, and the Claim(s) 1-27, 38, and 53 in [0002]-[0006], [0027]-[0179] in Fig. 1-20), wherein said extracellular vesicles are introduced by adding them to said flowing media (See how the fluidic synthesizer 110, the fluidic addressing system 120, and the fluid handler 195 controls fluid flow to the cells in [0029]-[0042], [0090] in Fig. 1 and claim(s) 17, 19, and 24).
Regarding Claim 114, Huh et al. teaches the method limitations of claim 110.
Huh et al. further teaches a method (See the Abstract, the microphysiological platform 100, and the Claim(s) 1-27, 38, and 53 in [0002]-[0006], [0027]-[0179] in Fig. 1-20), wherein extracellular vesicles added to the flowing media that are not taken up by said first cells are collected as they exit the microchannel (See how the fluidic synthesizer 110, the fluidic addressing system 120, and the fluid handler 195 controls fluid flow to the cells in [0029]-[0042], [0090] in Fig. 1 and claim(s) 17, 19, and 24).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following prior art teaches similar devices and methods: He (US20210268121A1) and Miklas et al. (US10254274B2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITNEY N. WASHINGTON whose telephone number is (703)756-5959. The examiner can normally be reached Monday-Friday 9:00am - 5:30pm CT.
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, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRITNEY N. WASHINGTON/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
Prosecution Insights