DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 76, 78-85, 87-94 and 96 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Brassil (US PGPub 2010/0028850).
Regarding Claim 76, Brassil et al teaches a fluidics system (referred to as an organ perfusion apparatus 1, illustrated in figures 1-2 or transporter 1900, illustrated in Figures 7-9) comprising one or more pressure transducers (referred to as the combination of pressure source, pressure cuff and compressor as described in [0037], and wherein flow and pressure sensors or transducers in transporter 1900 may be provided to monitor various organ characteristics including pump pressure and vascular resistance of an organ, see [0053]) configured to deliver liquids to an Organ Chip (referred to as the space within cassette 65 holding organ 60, including organ supporting surface 66) (see [0040]-[0042]).
Regarding Claim 78, Brassil teaches that said Organ Chip (including organ supporting surface 66) is integrated into an Organ Cartridge (specifically an organ cassette 65) (see Figures 2, 4 and [0042]).
Regarding Claims 79-80, Brassil teaches that said Organ Cartridge (cassette 65) resides in a Cartridge Dock (formed by walls 67a and 67b, with flanges 67c) (see [0046] and Figure 4C-D), wherein the cartridge dock comprises an interface (i.e. flanges 67c) to one or more Organ Cartridges (65)(see [0046]).
Regarding Claim 81, Brassil teaches that said Cartridge Dock interface (flange 67c) allows said Organ Cartridges to be attached and detached (see Figure 4 and [0046]). Furthermore, Brassil teaches that he cassette 65 may be provided with tubing for connection to the organ 60 and/or to remove medical fluid from an organ bath, and one or more connection devices 64 for connecting the tubing to, for example, tubing 50c, 81, 82, 91 and/or 132 (see, for example, FIG. 4D) of an organ storage, transporter, perfusion and/or diagnostic apparatus (see [0042]).
Regarding Claim 82, Brassil teaches a fluidics system (referred to as an organ perfusion apparatus 1, illustrated in figures 1-2 or transporter 1900, illustrated in Figures 7-9) comprising one or more pressure transducers (referred to as the combination of pressure source, pressure cuff and compressor as described in [0037], and wherein flow and pressure sensors or transducers in transporter 1900 may be provided to monitor various organ characteristics including pump pressure and vascular resistance of an organ, see [0053]) configured to deliver liquids to an Organ cartridge (referred to as organ cassette 65) (see [0040]-[0042] and Figure 4).
Regarding Claims 83-84, Brassil teaches that said organ cartridge (i.e. organ cassette 65) acts as an interface to at least one organ chip (referred to as the space within cassette 65 holding organ 60, including organ supporting surface 66), wherein said organ cartridge (organ cassette 65) comprises at least part of the organ chip (see [0041]-[0042], Figure 2 and Figure 4).
Regarding Claim 85, Brassil teaches that said Organ Cartridge (organ cassette 65) comprises a base substrate which provides: (a) a holder (comprising walls 67a and 67b) and connections (which are flanges 67c) for at least one Organ Chip (see Figures 2 and 4, holding organ supporting surface 66); and (b) at least one fluidic circuit having an inlet and an outlet, in connection with the at least one Organ Chip (referred to as tubings and/or connection device 64) (see Figure 4D and [0046]).
Regarding Claims 87-89, Brassil teaches that said Organ Cartridge (cassette 65) resides in a Cartridge Dock (formed by walls 67a and 67b, with flanges 67c) (see [0046] and Figure 4C-D), wherein the cartridge dock comprises an interface (i.e. flanges 67c) to one or more Organ Cartridges (65)(see [0046]), and Brassil also discloses that said interface allows said Organ Cartridges to be attached and detached (see Figure 4 and [0046]). Furthermore, Brassil teaches that he cassette 65 may be provided with tubing for connection to the organ 60 and/or to remove medical fluid from an organ bath, and one or more connection devices 64 for connecting the tubing to, for example, tubing 50c, 81, 82, 91 and/or 132 (see, for example, FIG. 4D) of an organ storage, transporter, perfusion and/or diagnostic apparatus (see [0042]).
Regarding Claims 90-91, Brassil teaches a fluidics system (referred to as an organ perfusion apparatus 1, illustrated in figures 1-2 or transporter 1900, illustrated in Figures 7-9) comprising one or more pressure transducers (referred to as the combination of pressure source, pressure cuff and compressor as described in [0037], and wherein flow and pressure sensors or transducers in transporter 1900 may be provided to monitor various organ characteristics including pump pressure and vascular resistance of an organ, see [0053]) configured to deliver liquids to a cartridge dock (formed by walls 67a and 67b, with flanges 67c) (see [0046] and Figure 4C-D), wherein the cartridge dock comprises an interface (i.e. flanges 67c) to one or more Organ Cartridges (65)(see [0046]).
Regarding Claims 92-93, Brassil teaches that said Organ Cartridge (cassette 65) resides in a Cartridge Dock (formed by walls 67a and 67b, with flanges 67c) (see [0046] and Figure 4C-D), wherein the cartridge dock comprises an interface (i.e. flanges 67c) to one or more organ chips ((referred to as the space within cassette 65 holding organ 60), including organ supporting surface 66)(see [0046]), which allows said Organ Cartridges to be attached and detached (see Figure 4 and [0046]). Furthermore, Brassil teaches that he cassette 65 may be provided with tubing for connection to the organ 60 and/or to remove medical fluid from an organ bath, and one or more connection devices 64 for connecting the tubing to, for example, tubing 50c, 81, 82, 91 and/or 132 (see, for example, FIG. 4D) of an organ storage, transporter, perfusion and/or diagnostic apparatus (see [0042]).
Regarding Claim 94, Brassil teaches that said Organ Cartridge (organ cassette 65) comprises a base substrate which provides: (a) a holder (comprising walls 67a and 67b) and connections (which are flanges 67c) for at least one Organ Chip (see Figures 2 and 4, holding organ supporting surface 66); and (b) at least one fluidic circuit having an inlet and an outlet, in connection with the at least one Organ Chip (referred to as tubings and/or connection device 64) (see Figure 4D and [0046]).
Regarding Claim 96, Brassil teaches that said organ cartridge (organ cassette 65) comprises an organ Chip (including organ supporting surface 66) is integrated into an Organ Cartridge (specifically an organ cassette 65) as part of the organ cartridge (65) (see Figures 2, 4 and [0042]).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claim 77, 86 and 95 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brassil as applied to claims 76, 83 and 93, and further in view of Li et al (US PGPub 20080102478 ).
Regarding Claims 77, 86 and 95, Brassil does not explicitly disclose that said Organ Chip is a microfluidic device that comprises living cells cultured within the microfluidic device.
However, in the analogous art of chips used as a multi-organ tissue model systems, Li et al teaches that in order to mimic what happens to experimental drugs in vivo, microfluidic systems lined with living cells have been developed to simulate human and animal organ systems (see [0006]). Furthermore, Li et al teaches a polymeric chip, which comprises at least one porous scaffold in the chip, wherein the porous scaffold includes a first surface and a second surface, and wherein the first surface is opposite from the second surface; a first microfluidic inlet channel, wherein the first microfluidic inlet channel is in fluid connectivity with the first surface of the porous scaffold; and a second microfluidic outlet channel, wherein the second microfluidic outlet channel is in fluid connectivity with the second surface of the porous scaffold. The surface can be the entire area defined by either the upper or lower perimeter of the porous scaffold. The first porous scaffold can have a plurality of first living cells, such as liver cells, and the second porous scaffold can have a plurality of second living cells, such as cancer cells and wherein the living cells provide a cell culture (see [0012] and [0018]). Accordingly, it would have been obvious to one of ordinary skill in the art to modify the organ chip of Brassil by incorporating living cells cultured within (as taught by Li et al) for the benefit of providing an effective cell culture for various diseases while allowing one to mimic what happens to experimental drugs in vivo.
Claim 77, 86 and 95 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brassil as applied to claims 76, 83 and 93, and further in view of Wikswo et al (US PGPub 20060154361).
Regarding Claims 77, 86 and 95, Brassil does not explicitly disclose that said Organ Chip is a microfluidic device that comprises living cells cultured within the microfluidic device in order to monitor the status of such a living system that is metabolically active and responsive to environmental change (see [0006]).
However, in the analogous art of bioreactor systems, Wikswo et al teaches using a bioreactor with cultured living cells Accordingly, it would have been obvious to one of ordinary skill in the art to modify the organ chip of Brassil by incorporating living cells cultured within (as taught by Wikswo et al) for the benefit of enabling the organ chip to be able to monitor the status of such a living system that is metabolically active and responsive to environmental change.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Guenther et al (US PGPub 20110287469) discloses a device for investigation of a flow conduit comprising: a base; and a module formed in the base, the module comprising: a main channel for the flow conduit, the main channel having a loading inlet for loading the flow conduit; a culture chamber in the main channel for at least one of perfusion and superfusion of the flow conduit; at least two fixation lines in communication with the main channel for providing fixation of the flow conduit at at least two fixation locations along the length of the flow conduit (see abstract). In addition, Guenther et al teaches that the device may include sensors to sense and measure perfusion and/or superfusion. For example, pressure drop sensors may be integrated on the device (e.g., using piezoresistive pressure transducers), which may provide indication of perfusion and/or superfusion (see [0069]).
Hassanein et al (US PGPub 20060154357 ) discloses systems and/or devices of the invention include, and/or the methods of the invention employ, one or more of: an organ chamber assembly for containing a heart during ex-vivo care; a reservoir for containing and optionally, defoaming and/or filtering a volume of perfusion fluid; a perfusion fluid pump for pumping/circulating perfusion fluid to and from the harvested heart; a heater assembly for maintaining the temperature of the perfusion fluid at or near physiological temperatures; a flow mode selector valve for switching between normal and retrograde flow modes; an oxygenator for re-oxygenating the perfusion fluid subsequent to it being expelled by the heart; a nutritional subsystem for replenishing nutrients in the perfusion fluid as they are metabolized by the heart and for providing preservatives to the perfusion fluid to reduce, for example, ischemia and/or other reperfusion related injuries to the heart; a sensor subsystem for monitoring, for example, temperature, pressure, flow rate and/or oxygenation of the perfusion fluid, and/or electrical signals from the heart and/or the various components employed to maintain suitable flow conditions to and from the heart; an operator interface for assisting an operator in monitoring system operation and/or the condition of the heart, and/or for enabling the operator to set various operating parameters; a power subsystem for providing fault tolerant power to the organ care system; and a control subsystem for controlling operation of the organ care system (see [0011]). In addition, Hassanein et al teaches the use of pressure transducers (see [0176]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER WECKER whose telephone number is (571)270-1109. The examiner can normally be reached 9:30AM - 6 PM EST 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, 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.
/JENNIFER WECKER/ Primary Examiner, Art Unit 1797