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 .
Response to Amendment
This office action is responsive to the preliminary amendment filed on 02/25/2022. As directed by the amendment: Claims 1, 2, 4, 6, 7, 12, 14, 15, 18-21, 38, 39, and 59 have been amended, claims 3, 5, 8-11, 13, 16, 17, 22-37, 40-58 and 60-63 have been cancelled, and no claims have been added. Thus, claims 1, 2, 4, 6, 7, 12, 14, 15, 18-21, 38, 39, and 59 are presently pending in this application.
Specification
The disclosure is objected to because of the following informalities: Inconsistent wording with “113” is referred to as an outlet and output.
Appropriate correction is required.
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
The disclosure is objected to because of the following informalities:
b) Cross reference to related application PCT 2019050547
G) Heading for the BACKGROUND section of the application
H) Heading for the BRIEF SUMMARY OF THE INVENTION section of the application
i) Heading for the BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S) section of the application
j) Heading for the DETAILED DESCRIPTION OF THE INVENTION section of the application
Appropriate correction is required.
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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 18 recites the broad recitation “microbubbles having a diameter below 10 micrometer”, and the claim also recites that microbubbles diameter “preferably in a range of 2-5 micrometer” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claims 1, 2, 4, 6, 7, 12, 14, 15, 18-21, 38, 39, and 59 are rejected under 35 U.S.C. 103 as being unpatentable over Cronin (US 20110282381 A1) in view of Uber (US 20040253183 A1).
In regards to claim 1, Cronin teaches of a cartridge (bioprocessing module 400, Fig.23), comprising:
a cartridge body (body of bioprocessing module 400, Fig.23);
one or more gas inlets (gas inlet 402, Fig.24) formed in the cartridge body (gas inlet 402 is within body 400, Fig.24);
a fluid storage system formed in the cartridge body (as seen with the bioprocessing module 400 in Fig. 24) and comprising one or more fluid storage units (fluid storage system that encompasses reservoirs 418,420,422 [0168], Fig.24), each fluid storage unit being configured for holding a respective fluid (reservoirs are for holding a variety of media and they are each a fluid cartridge [0169], Fig.24) and for outputting said fluid in response to a pressurized gas being supplied to the fluid storage unit (pressurized CO.sub.2 will be provided under pressure in gas manifold [0170]) through a gas inlet among the one or more gas inlets by using the supplied gas as a propellant ("fluid media will be expelled from a reservoir when its corresponding media valve is opened" [0170], Fig.24);
and a mixing unit arranged in or mounted to the cartridge body (mixing chamber 408, Fig.24) and being in fluid communication with the fluid storage unit(s) using a fluid channel or fluid channels formed in the cartridge body (Fig.24 shows that mixing chamber 408 is in communication with reservoirs (418,420,422) through channels (424,426,428)), said mixing unit being configured for mixing a fluid outputted from a fluid storage unit with a pressurized first gas received through a gas inlet among the one or more gas inlets (mixing chamber 408 mixes fluid from fluid reservoirs, pressurized by , CO.sub.2, with the gas manifold 438 [0170, 0167]);
wherein at least one fluid held in the fluid storage system is a liquid (medical fluid [0081] and "fluid or other material" from mixing chamber [0171]);
and wherein the mixing unit is configured to mix at least one liquid received from the fluid storage system with the pressurized first gas (there is fluid communication from pressurized gas from gas manifold 438 and the reservoirs (418,420, 422) lead into mixing chamber 408 [0170], Fig.24),
Although Cronin teaches of the mixing unit compromising a mechanism to help mix (" mixing feature such as a rotating impeller may be provided in mixing chamber (126) to facilitate mixing of the media. " [0139]), Cronin fails to teach that mixing unit comprising a microfluidics device configured for generating microbubbles within said at least one liquid that are filled with the pressurized first gas.
However, Uber teaches of mixing unit (system 2 is used within a medium, and thus can be used within the mixing chamber of Cronin, [0051], Fig. 2B) comprising a microfluidics device (system 2, the general embodiment of system 1, is used within a medium, [0051], Fig. 2A) configured for generating microbubbles (system 1 is "for creating microbubbles on demand for use within a medium" [0051], Fig. 2A) within said at least one liquid (liquid from container 30 [0051, 0052], Fig. 2B) filled with the pressurized first gas ("the microbubbles are created by disrupting a liquid in the presence of a gas" [0053, 0059]).
Both Uber and Cronin teach of devices for enabling delivery of a therapeutic fluid. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mixing unit of Cronin to have included that the mixing unit compromises of a microfluidics device for generating microbubbles, as taught by Uber. Doing so would have made sense because the microbubbles are used as contrast agent for imaging purposes [0009], which Cronin teaches that any of the components of the device can be configured to be “compatible with or optimize their use with various imaging technologies” [0277].
In regards to claim 2, Cronin teaches of wherein at least one liquid held in the fluid storage system is intended for intracorporeal use in a human or animal, for example for intravenous use or intra-cavity use (Fig. 37 depicts delivery probe for transoral delivering a tissue repair composition to a patient's stomach [0208] and where media reservoirs are needed for tissue repair composition or medical fluid in the mixing chamber [0131]), wherein the at least one liquid optionally comprises or is used to form a diagnostic agent, such as a contrast agent for medical imaging, or a therapeutic agent, such as a medicament (tissue repair composition and medical fluid" and where media reservoirs are needed for "tissue repair composition or medical fluid in the mixing chamber" [0131]).
In regards to claim 4, Cronin teaches of wherein each fluid storage unit (specifically the fluid storage system that encompasses reservoirs 418,420,422 [0168], Fig.24 as well as general embodiments as seen in Fig. 4,5 [0169]) comprises a fluid storage unit inlet (reservoirs 418,420,422 has inlet from gas manifold 438 to each reservoir, Fig.24, [0168]) and a fluid storage unit outlet (reservoirs 418,420,422 has outlet conduits 424,426,428, Fig. 24, [0167,0168]),
wherein the fluid storage unit is configured such that the pressurized gas supplied to the fluid storage unit through the fluid storage unit inlet pushes the fluid in the fluid storage unit through the fluid storage unit outlet (media reservoirs 418,420,422 are pressurized by gas manifold 438 to which the media is expelled from the reservoir to the mixing chamber [0170]), wherein at least one fluid storage unit (fluid storage system that encompasses reservoirs 418,420,422 [0168], Fig.24) comprises:
a storage chamber (fluid cartridge, such as the media filled tissue repair matrix cartridge 94 as seen in Fig. 6 [0105], “In some versions, reservoirs (418, 420, 422) may each comprise a fluid cartridge that may be similar to those previously described with respect to other examples, such that the fluid cartridges may be removably secured to or within bioprocessing module (400)” [0169]) configured for receiving (the media filled tissue repair matrix cartridge 94 is capable of receiving/having [0105]) a sealed off container (media filled tissue repair matrix cartridge 94 with seal 100 [0105], Fig. 5) in which a liquid is held (tissue repair matrix cartridge 94 may contain any suitable fluid [0105]) in a sterile and sealed off manner (fluid is contained within the cartridge 94 with a seal on “in order to prevent media leakage prior to use” and thus does not have fluid communication with the fluid conduit when the seal is there [0105]);
and a liquid reservoir (plunger 91 [0105], Fig. 5) in fluid communication with the storage chamber (fluid conduit 94 is in communication with plunger 91 through fluid conduit 92, 98 [0105], Fig. 5), wherein the fluid storage unit inlet (inlet port 47 in Fig. 5 [0108] and reservoirs 418,420,422 has inlet from gas manifold 438 to each reservoir, Fig.24, [0168]) is connected to one of the storage chamber inlet port 47 is fluidly connected ton tissue repair matrix cartridge 94 as seen in Fig. 5) and the liquid reservoir (inlet port 47 is connected to plunger 91 [0105], Fig. 5) and wherein the fluid storage unit outlet (as depicted by end of tissue repair matrix cartridge 94 besides plunger head 70 ) is connected to the liquid reservoir (end of cartridge 94 is fluidly connected to plunger 91 through the fluid conduit 98 as can be seen in Fig.5,as well end of cartridge 94 is connected to plunger 68, Fig.5) wherein the liquid reservoir is configured for collecting liquid (plunger 91 is capable of receiving fluid) that is released from the container after the container has been broken, ruptured, cut, or pierced (plunger 91 collects the fluid after the seal 100 has been pierced [0105], Fig. 5,6).
In regards to claim 6, Cronin teaches that wherein the sealed off container(s) (media filled tissue repair matrix cartridge 94 with seal 100 [0105], Fig. 5) comprise(s) a packaging in blister package (seal 100 can be packaged to be made out of plastic [0277]).
In regards to claim 7, Cronin teaches wherein the sealed off container is fixedly held in the storage chamber, for example by means of an adhesive;
or wherein, for at least one fluid storage unit, the liquid reservoir is formed as a part of the storage chamber;
or wherein said at least one fluid storage unit (fluid storage system that encompasses reservoirs 418, 420, 422 [0168], Fig.24) comprises a fluid channel channels (424,426,428) formed in the cartridge body (body of bioprocessing module 400, Fig.23) connecting the storage chamber (“In some versions, reservoirs (418, 420, 422) may each comprise a fluid cartridge that may be similar to those previously described with respect to other examples, such that the fluid cartridges may be removably secured to or within bioprocessing module (400)” [0169], and thus using the embodiment of the reservoir disclosed in Fig. 5,6, the channels 424,426,428 can be connected with a fluid cartridge, such as the media filled tissue repair matrix cartridge 94 [0105]) and the liquid reservoir (plunger 91 [0105], Fig. 5);
or wherein, for a fluid storage unit among said at least one fluid storage unit, the storage chamber comprises a supporting surface for supporting the sealed off container and at least one protruding pin or needle extending towards the sealed off container for the purpose of puncturing through the sealed off container if sufficient force is exerted onto the sealed off container, wherein at least one fluid storage unit is provided with a protective ring that protrudes away from the cartridge body further than the sealed off container when it is placed in the storage chamber.
In regards to claim 12, Cronin teaches of the cartridge (bioprocessing module 400, Fig.23) compromising of a plurality of said fluid storage units (reservoirs 418,420 and 422, Fig.24), wherein the fluid storage unit inlets of at least two fluid storage units are in fluid communication with each other (gas manifold 438 fluidly connect reservoir 418,420 and 424, [0170], Fig.24),wherein the gases used as propellants by the plurality of fluid storage units are optionally identical (gas from CO.sub.2 that is in gas manifold 438 is identical since it's the same gas used in the reservoirs 418,420 and 424, Fig.24).
In regards to claim 14, Cronin teaches of the cartridge (bioprocessing module 400, Fig.23) wherein the gas inlet (gas inlet 402, Fig.24) through which the pressurized first gas is received is the same as the gas inlet through which the pressurized gas is received that is used as propellant (same pressurized gas of CO.sub.2 that is used by gas manifold 438 is used by reservoir since reservoirs are pressurized by CO.sub.2 [0170], Fig.24) by at least one fluid storage unit (gas manifold 438 is in fluid communication with media reservoirs (418, 420, 422) [0170], Fig. 24).
In regards to claim 15, Cronin teaches of wherein the pressurized first gas (CO2 starts from the same main source, the gas that passes from 446 into 408, Fig. 24, [0170]) is different (the gas that passes from 446 into 408 is not the same gas that enters 418, 420, and 422 and pushes on the fluid(s) because the gas is affected by the fluids, thus the gas changing in pressure, volume and potentially temperature) from the pressurized gas(ses) that is/are used as propellant(s) (gas that enters 418, 420, and 422 and pushes on the fluid(s) in the fluid storage system that encompasses reservoirs 418,420,422, [0175] [0171], Fig. 24) by the at least one fluid storage unit (gas from after valve 446 to mixing chamber 408 is different from the gas that enters reservoirs 418, 420, and 422 and pushes on the fluid(s) [0170] and [0175], Fig. 24), wherein the cartridge optionally has a single fluid storage unit (one unit that is fluid storage system that encompasses reservoirs 418,420,422 [0168], Fig.24), and two gas inlets (gas inlet going into valve 466 to 408 and the other gas inlet going into reservoir 418 to 408 [0175], Fig. 24), wherein a first gas inlet among the two gas inlets is in fluid communication with the mixing unit (gas inlet that goes into valve 446 is in fluid communication with mixing chamber 408 as seen in Fig. 24 [0175], Fig.24) and wherein a second gas inlet among the two gas inlets is in fluid communication with the fluid storage unit (gas inlet going into 418 is in fluid communication with fluid storage system that encompasses reservoirs 418,420,422, [0175], Fig.24).
In regards to claim 18, Uber, as modified to be in Cronin, further teaches that the microfluidics device (system 2, the general embodiment of system 1, is used within a medium, [0051], Fig. 2A) is configured for generating microbubbles (system 1 is "for creating microbubbles on demand for use within a medium" [0051], Fig. 2A) having a diameter below 10 micrometer (Microbubbles have a diameter between about 0.5 and 300 .mu.m and mentions that “For transpulmonary use, the microbubbles have a diameter preferably not more than about 10 to 3 .mu.m” [0068]).
Both Uber and Cronin teach of devices for enabling delivery of a therapeutic fluid. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the microfluidics device as taught by Uber to specify that the diameter of the microbubbles generated by the microfluidics device is less than 10 micrometers. Doing so makes sense because large microbubbles are created so that they can shrink when employed in a gas mixture, since gases such as with carbon dioxide, dissolve in the liquid, as well as indicating a size of the microbubbles is important since size is “thus a function of the volumetric flow rate of liquid 120” [0099]).
In regards to claim 19, Cronin teaches of wherein the pressurized first gas comprises one or more gases from the group consisting of SF6, N2, CO2, 02, H2, He, Ar, ambient air, and perfluorocarbon gases, such as CF4, C2F6, C2F8, C3F6, C3F8, C4F6, C4F8, C4F10, C5F10, C5F12 and mixtures thereof (pressurized by CO.sub.2 [0170]).
In regards to claim 20, Cronin teaches of wherein said at least one liquid received from the fluid storage system (comprises at least one liquid from the group consisting of water, dispersion of lipids, such as phospholipids, or proteins in an aqueous solution, active pharmaceutical ingredients, and alcohols (“Bioprocessing module (400) may be provided to an end-user with first, second and third media reservoirs (418, 420, 422) already filled with a variety of media suitable for formulating a tissue repair composition within mixing chamber (408)” [0169] as well as fluid can be “any other material suitable to be mixed with biological material and introduced to a wound or defect site, including combinations of materials” [0073] and thus alginate is an active pharmaceutical ingredient).
In regards to claim 21, Cronin fails to teach of wherein the microfluidics device comprises: a first inlet for receiving the pressurized first gas; a second inlet for receiving said at least one liquid; a bubble formation channel for generating the microbubbles based on a flow of the first pressurized gas received through the first inlet and a flow of the at least one liquid received through the second inlet.
However, Uber teaches of wherein a microfluidics (system 2 [0051, 0058], Fig. 2B) device a (pressure source 140 that can be electrolytic fluid cells [0035], Fig.2) comprises: a first inlet (channel out of secondary container 30'' that holds the gas, [0059], Fig. 2B) for receiving the pressurized first gas (secondary container 30'' is a reservoir for a gas [0059]); a second inlet (channel coming out of primary container 30 [0056], Fig. 2B) for receiving said at least one liquid (primary container 30 holds liquid [0056], Fig. 2B); a bubble formation channel (microbubble generator 32, [0058], Fig. 2B) for generating the microbubbles (microbubble generator makes microbubbles [0058]) based on a flow of the first pressurized gas received through the first inlet and a flow of the at least one liquid received through the second inlet (when the generation of microbubbles is stopped, so is the fluid flow [0065], "the liquid flow path 110 channels the pressurized liquid over the gas flow path 111 to entrain the gas 121 emanating therefrom as microbubbles in the liquid" [0098], size of microbubbles depends on volumetric flow rate of liquid and the volumetric rate of which gas is injected [0099])).
Both Uber and Cronin teach of devices for enabling delivery of a therapeutic fluid. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the microfluidics device to compromise a first inlet for receiving the pressurized first gas; a second inlet for receiving said at least one liquid; a bubble formation channel for generating the microbubbles based on a flow of the first pressurized gas received through the first inlet and a flow of the at least one liquid received through the second inlet. Doing so makes sense in order to uniformize microbubbles size and to “produce microbubbles of the desired size” since the size of the microbubbles is thus a function of the volumetric flow rate of liquid and gas injected [0099].
In regards to claim 38, Cronin teaches of a cartridge system, comprising: a cartridge as defined in claim 1 (bioprocessing module 400, Fig.23);
a device (tissue repair device 380, Fig. 23, [0163]) comprising a housing (housing 382, [0163], Fig.23) with an opening (chamber 386, Fig. 23,[0166]) in which the cartridge can be releasably inserted (Bioprocessing module 400 can be "detachably positioned within chamber (386) provided in housing (382) of tissue repair device (380)" [0166], Fig.23) ;
wherein the device comprises one or more nozzles (as shown by end effectors as first harvesting probe 470 and second harvesting probe 490, Fig.23) inserting a respective pressurized gas into the one or more gas inlets (pressurized gas enters the gas conduit 398 which "is used to move and expel various media contained within bioprocessing module" [0165], Fig.23-24) respectively, for the purpose of said mixing by the mixing unit of the cartridge (gas manifold connects to mixing chamber [0170]).
In regards to claim 39, Cronin teaches the system according to claim 38, wherein each fluid storage unit (fluid storage system that encompasses reservoirs 418,420,422 [0168], Fig.24) comprises a fluid storage unit inlet (reservoirs 418,420,422 has inlet from gas manifold 438 to each reservoir, Fig.24, [0168]) and a fluid storage unit outlet (reservoirs 418,420,422 has outlet conduits 424,426,428, Fig. 24, [0167,0168]), wherein the fluid storage unit (fluid storage system that encompasses reservoirs 418,420,422 [0168], Fig.24) is configured such that the pressurized gas supplied to the fluid storage unit (pressurized CO.sub.2 will be provided under pressure in gas manifold 438 that is in communication with the reservoirs 418,420,422 [0170]) through the fluid storage unit inlet (the gas goes through the inlet of the reservoirs 418,420,422 [0170], Fig. 24) pushes the fluid in the fluid storage unit through the fluid storage unit outlet (“Since the media reservoirs (418, 420, 422) are thus pressurized by CO.sub.2 from gas manifold (438), fluid media will be expelled from a reservoir when its corresponding media valve 430, 432, 434 is opened” [0170], Fig. 24), wherein at least one fluid storage unit comprises:
a storage chamber (fluid cartridge, such as the media filled tissue repair matrix cartridge 94 as seen in Fig. 6 [0105], “In some versions, reservoirs (418, 420, 422) may each comprise a fluid cartridge that may be similar to those previously described with respect to other examples, such that the fluid cartridges may be removably secured to or within bioprocessing module (400)” [0169]) configured for receiving (the media filled tissue repair matrix cartridge 94 is capable of receiving/having [0105]) a sealed off container (media filled tissue repair matrix cartridge 94 with seal 100 [0105], Fig. 5) in which a liquid is held (tissue repair matrix cartridge 94 may contain any suitable fluid [0105]) in a sterile and sealed off manner (fluid is contained within the cartridge 94 with a seal on “in order to prevent media leakage prior to use” and thus does not have fluid communication with the fluid conduit when the seal is there [0105]);
and a liquid reservoir (plunger 91 [0105], Fig. 5) in fluid communication with the storage chamber (fluid conduit 94 is in communication with plunger 91 through fluid conduit 92, 98 [0105], Fig. 5), wherein the fluid storage unit inlet (inlet port 47 in Fig. 5 [0108] and reservoirs 418,420,422 has inlet from gas manifold 438 to each reservoir, Fig.24, [0168]) is connected to one of the storage chamber inlet port 47 is fluidly connected ton tissue repair matrix cartridge 94 as seen in Fig. 5) and the liquid reservoir (inlet port 47 is connected to plunger 91 [0105], Fig. 5) and wherein the fluid storage unit outlet (as depicted by end of tissue repair matrix cartridge 94 besides plunger head 70 ) is connected to the liquid reservoir (end of cartridge 94 is fluidly connected to plunger 91 through the fluid conduit 98 as can be seen in Fig.5,as well end of cartridge 94 is connected to plunger 68, Fig.5) wherein the liquid reservoir is configured for collecting liquid (plunger 91 is capable of receiving fluid) that is released from the container after the container has been broken, ruptured, cut, or pierced (plunger 91 collects the fluid after the seal 100 has been pierced [0105], Fig. 5,6).
and wherein the device (device of bioprocessing module 400 as disclosed by Fig.24 as well as general embodiments as seen in Fig. 4,5 [0169]) further comprises an engaging unit (plunger 91 may include a proximally extending hollow needle tip that is configured to pierce seal 100 [0105]) for engaging a sealed off container (needle tip is engaging by piercing the seal 100 [0105]) arranged in a storage chamber (fluid cartridge, such as the media filled tissue repair matrix cartridge 94 as seen in Fig. 6 [0105], [0169]) of at least one fluid storage unit (fluid storage system that encompasses reservoirs 418,420,422 [0168], Fig.24) for the purpose of causing the sealed off container to break, rupture, or to become cut or pierced (needle is there to pierce the seal [0105]).
In regards to claim 59, Cronin teaches of a cartridge (bioprocessing module 400, Fig.23) configured for mixing a liquid held in the cartridge (the bioprocessing module 400 has a mixing chamber 408 to be able to mix fluid within the module 400 [0175]), within the cartridge, with a pressurized gas supplied to the cartridge (pressurized gas from CO.sub.2 cartridge 396 [0175], Fig.23) , wherein the liquid is intended for intracorporeal use in a human or animal (liquid for use in human tissue [0131]), for example for intravenous use or intra-cavity use (Fig. 37 depicts delivery probe for transoral delivering a tissue repair composition to a patient's stomach [0208] and where media reservoirs are needed for tissue repair composition or medical fluid in the mixing chamber [0131]), wherein the liquid held in the cartridge comprises or is used to form a diagnostic agent, such as a contrast agent for medical imaging, or a therapeutic agent, such as a medicament (tissue repair composition and medical fluid" and where media reservoirs are needed for "tissue repair composition or medical fluid in the mixing chamber" [0131]), wherein the cartridge comprises a mixing unit configured to mix said liquid with said pressurized first gas (mixing chamber 408 mixes fluid from fluid reservoirs, pressurized by , CO.sub.2, with the gas manifold 438 [0170, 0167]).
Cronin fails to teach of a mixing unit comprising a microfluidics device configured for generating microbubbles within said liquid that are filled with the pressurized gas.
Uber teaches of a mixing unit (system 2 is used within a medium, and thus can be used within the mixing chamber of Cronin, [0051], Fig. 2B) comprising a microfluidics device (system 2, the general embodiment of system 1, is used within a medium, [0051], Fig. 2A) configured for generating microbubbles (system 1 is "for creating microbubbles on demand for use within a medium" [0051], Fig. 2A) within said liquid (liquid from container 30 [0051, 0052], Fig. 2B) that are filled with the pressurized gas ("the microbubbles are created by disrupting a liquid in the presence of a gas" [0053, 0059]).
Both Uber and Cronin teach of devices for enabling delivery of a therapeutic fluid. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mixing unit of Cronin to have included that the mixing unit compromises of a microfluidics device for generating microbubbles, as taught by Uber. Doing so would have made sense because the microbubbles are used as contrast agent for imaging purposes [0009], which Cronin teaches that any of the components of the device can be configured to be “compatible with or optimize their use with various imaging technologies” [0277].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMINA JAMIL ISHRAT whose telephone number is (703)756-4563. The examiner can normally be reached Monday-Friday 7:30am-5pm ET.
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, Nathan Price can be reached on (571) 270-5421. 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.
/AMINA ISHRAT/ Examiner, Art Unit 3783
/NATHAN R PRICE/ Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights