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 .
Acknowledgments
In the reply, filed on July 30, 2025, Applicant amended claims 1, 15, 18, 38, and 59.
Applicant cancelled claim 14.
In the non-final rejection of May 7, 2025, Examiner objected to the Disclosure. Applicant amended the Specification. Objection is withdrawn.
Examiner rejected claim 18 under 35 U.S.C. 112(b). Applicant amended claim 18. Rejection is withdrawn.
Claim Objections
Claims 1, 4, 7, and 15 are objected to because of the following informalities:
In regards to claim 1, lines 15-16, “at least one fluid storage unit” should be changed to “the at least one fluid storage unit”.
In regards to claim 4, line 5, “at least one fluid storage unit” should be changed to “the at least one fluid storage unit”.
In regards to claim 7, line 4, “at least one fluid storage unit” should be changed to “the at least one fluid storage unit”.
In regards to claim 7, line 11, “at least one fluid storage unit” should be changed to “the at least one fluid storage unit”.
In regards to claim 15, line 6, “at least one fluid storage unit” should be changed to “the at least one fluid storage unit”.
In regards to claim 15, line 15, “at least one fluid storage unit” should be changed to “the at least one fluid storage unit”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 59 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regards to claim 59, lines 1-3 recite: A cartridge configured for mixing a liquid held in the cartridge, within the cartridge, with a pressurized gas supplied to the cartridge “through a first gas inlet”; however, such is new matter not described in the Specification. Claim 1, lines 15-17 instead describe: to mix the liquid received from at least one storage unit with the pressurized first gas “received from the second gas inlet”.
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 1-2, 4, 6-7, 12, 15, 18-21, and 38-39 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.
In regards to claim 1, lines 11-12 recite “at least one fluid storage unit”. Claim 1, lines 4-5 previously recite “one or more fluid storage units”. It is unclear whether the two recitations are the same or different. Claims 2, 4, 6-7, 12, 15, 18-21, and 38-39 are rejected by virtue of being dependent upon claim 1.
In regards to claim 15, line 5 recites “a first gas inlet”. Claim 15 depends upon claim 1. Claim 1, line 7 recites “a first gas inlet”. It is unclear whether the two recitations are the same or different.
In regards to claim 15, line 6 recites “a second gas inlet”. Claim 15 depends upon claim 1. Claim 1, line 12 recites “a second gas inlet”. It is unclear whether the two recitations are the same or different.
Claim Rejections - 35 USC § 102
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 1-2, 4, 6-7, 12, 15, 18-21, and 59 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van Hoeve et al (US 2018/0008951).
In regards to claim 1, Van Hoeve et al teaches a cartridge (Figure 2), comprising:
a cartridge body (Figure 2)
one or more gas inlets (labeled as “first gas inlet” and “second gas inlet” in Figure 2 below) formed in the cartridge body
a fluid storage system (6) formed in the cartridge body and comprising one or more fluid storage units (6), each fluid storage unit being configured for holding a respective fluid (7) and for outputting said fluid in response to a pressurized gas being supplied to the fluid storage unit through a first gas inlet (labeled in Figure 2 below) among the one or more gas inlets by using the supplied gas as a propellant (paragraph [0015])
a mixing unit (1) arranged in or mounted to the cartridge body and being in fluid communication with the fluid storage unit(s) using a fluid channel or fluid channels (labeled in Figure 2 below) formed in the cartridge body, said mixing unit being configured for mixing the fluid outputted from at least one fluid storage unit with a pressurized first gas received through a second gas inlet (labeled in Figure 2 below) among the one or more gas inlets (paragraphs [0016][0018])
wherein at least one fluid held in the fluid storage system is a liquid (7)
wherein the mixing unit is configured to mix the liquid received from at least one fluid storage unit with the pressurized first gas received from the second gas inlet, said mixing unit comprising a microfluidics device (1) configured for generating microbubbles within said at least one liquid that are filled with the pressurized first gas (paragraph [0018])
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In regards to claim 2, Van Hoeve et al teaches 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, 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 (paragraph [0002]).
In regards to claim 4, Van Hoeve et al teaches wherein each fluid storage unit comprises a fluid storage unit inlet and a fluid storage unit outlet (Figure 2), 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 (paragraph [0015]), wherein at least one fluid storage unit comprises:
a storage chamber (6) configured for receiving a sealed off container in which a liquid is held in a sterile and sealed off manner (paragraph [0015])
a liquid reservoir (1) in fluid communication with the storage chamber, wherein the fluid storage unit inlet is connected to one of the storage chamber and the liquid reservoir (Figure 2)
wherein the fluid storage unit outlet is connected to the liquid reservoir, wherein the liquid reservoir is configured for collecting liquid that is released from the container after the container has been broken, ruptured, cut, or pierced (Figure 2)
In regards to claim 6, it is noted that claim 6 is drawn to a cartridge intended to be used with sealed off container(s) comprising a blister package, and thus the sealed off container(s) comprising the blister package are not positively recited structures of the claimed cartridge. Van Hoeve et al teaches the claimed cartridge of claim 6 which has the ability to be used with sealed off container(s) comprising a blister package, as claimed, as the structure of the cartridge (Figure 2) is capable of receiving sealed off container(s) comprising a blister package.
In regards to claim 7, Van Hoeve et al teaches wherein said at least one fluid storage unit comprises a fluid channel (labeled in Figure 2 above) formed in the cartridge body connecting the storage chamber and the liquid reservoir (Figure 2), 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 (Figure 2).
In regards to claim 12, Van Hoeve et al teaches a plurality of said fluid storage units, wherein the fluid storage unit inlets of at least two fluid storage units are in fluid communication with each other (paragraph [0028]).
In regards to claim 15, Van Hoeve et al teaches wherein the pressurized first gas received through the second gas inlet is different from the pressurized gas(ses) supplied through the first gas inlet that is/are used as propellant(s) by the at least one fluid storage unit (Figure 2)
wherein the cartridge optionally has a single fluid storage unit (6), and two gas inlets (labeled as “first gas inlet” and “second gas inlet” in Figure 2 above), wherein a first gas inlet among the two gas inlets is in fluid communication with the mixing unit and wherein a second gas inlet among the two gas inlets is in fluid communication with the fluid storage unit (Figure 2)
In regards to claim 18, Van Hoeve et al teaches wherein the microfluidics device is configured for generating microbubbles having a diameter below 10 micrometer (paragraph [0003]).
In regards to claim 19, Van Hoeve et al teaches 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 (paragraph [0039]).
In regards to claim 20, Van Hoeve et al teaches 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 (paragraph [0039]).
In regards to claim 21, Van Hoeve et al teaches wherein the microfluidics device comprises:
a first inlet (3) for receiving the pressurized first gas
a second inlet (2) for receiving said at least one liquid
a bubble formation channel (1) 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
In regards to claim 59, Van Hoeve et al teaches a cartridge (Figure 2) configured for mixing a liquid (7) held in the cartridge, within the cartridge, with a pressurized gas supplied to the cartridge through a first gas inlet (labeled in Figure 2 above), wherein the liquid is intended for intracorporeal use in a human or animal, for example for intravenous use or intra-cavity use, 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 (paragraph [0002]), wherein the cartridge comprises a mixing unit (1) configured to mix said liquid with said pressurized first gas received through a second gas inlet (labeled in Figure 2 above) (paragraphs [0016][0018]), said mixing unit comprising a microfluidics device (1) configured for generating microbubbles within said liquid that are filled with the pressurized gas received through the second gas inlet (paragraph [0018])
Claim Rejections - 35 USC § 103
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.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Van Hoeve et al, as applied to claim 1 above, and further in view of Acker et al (US 2015/0320952).
In regards to claim 38, Van Hoeve et al teaches a cartridge system (Figure 2), comprising:
a cartridge (Figure 2)as defined in claim 1
Van Hoeve et al is silent about a device comprising a housing with an opening in which the cartridge can be releasably inserted; wherein the device comprises one or more nozzles for inserting a respective pressurized gas into the second gas inlet for the purpose of said mixing by the mixing unit of the cartridge. Acker et al teaches a cartridge system (Figures 1-2) comprising: a device (100) comprising a housing (100) with an opening in which a cartridge (110(A), 110(b), 140, 160, 180) can be releasably inserted; wherein the device comprises one or more nozzles (114(a)) for inserting a respective pressurized gas into a second gas inlet (101(a)) for the purpose of mixing by a mixing unit (140) of the cartridge. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the cartridge system, of Van Hoeve et al, with a device, as taught by Acker et al, as such will manage delivery of the gas from a gas source to a patient (paragraph [0002]) and will provide a protective covering to prevent degradation of the structures of the cartridge (Figures 1-2).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Van Hoeve et al and Acker et al, as applied to claim 38 above, and further in view of Rogers et al (US 2003/0040708).
In regards to claim 39, in the modified cartridge system of Van Hoeve et al and Acker et al, Van Hoeve et al teaches wherein each fluid storage unit comprises a fluid storage unit inlet and a fluid storage unit outlet (Figure 2), 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 (paragraph [0015])
wherein at least one fluid storage unit comprises:
a storage chamber (6) configured for receiving a sealed off container in which a liquid is held in a sterile and sealed off manner (paragraph [0015])
a liquid reservoir (1) in fluid communication with the storage chamber, wherein the fluid storage unit inlet is connected to one of the storage chamber and the liquid reservoir and wherein the fluid storage unit outlet is connected to the liquid reservoir (Figure 2)
wherein the liquid reservoir is configured for collecting liquid that is released from the container after the container has been broken, ruptured, cut, or pierced (Figure 2)
Van Hoeve et al and Acker et al are silent about wherein the device further comprises an engaging unit for engaging a sealed off container arranged in a storage chamber of at least one fluid storage unit for the purpose of causing the sealed off container to break, rupture, or to become cut or pierced. Rogers et al teaches a cartridge system (Figure 16) wherein a device further comprises an engaging unit (136) for engaging a sealed off container arranged in a storage chamber of at least one fluid storage unit for the purpose of causing the sealed off container to break, rupture, or to become cut or pierced (paragraph [0140]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device, of the modified cartridge system of Van Hoeve et al and Acker et al, to comprise an engaging unit, as taught by Rogers et al, as such will define the administration of the liquid in the storage chamber (paragraph [0140]) in order to maintain the liquid in a sealed state until ready for dispensing to a patient.
Response to Arguments
Applicant’s arguments with respect to claims 1-2, 4, 6-7, 12, 15, 18-21, 38-39, and 59 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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