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 .
Status of the Claims
The amendment filed 12/30/2025 has been entered. Claims 1-6, 8-18, and 21 are pending in the application; claims 19-20 remain withdrawn; and claim 7 is cancelled.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/30/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Response to Arguments
Applicant’s arguments filed 12/30/2025 have been considered but they are moot in view of a new grounds of rejection necessitated by the amendments to the claims. Applicant has added limitations to independent claim 1 for an in-line spectroscopy system (cancelled claim 7 incorporated into claim 1) and a stepper motor. These new limitations do not distinguish the claimed invention over the prior art. The Examiner acknowledges that neither Daniele et al. nor Becker et al. disclose a stepper motor; however, it would have been obvious to modify the system of Daniele et al. to include a stepper motor in view of Hassanein et al. (US 2015/0342177 A1), which will be discussed in further detail in the 35 U.S.C. § 103 section below.
Claim Objections
Claim 1 is objected to because of the following informalities: it is recommended that "communicably" in line 16 be deleted. Appropriate correction is required.
Applicant is advised that should claim 1 be found allowable, claim 21 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 21 does not specify a further structural limitation of the subject matter claimed, as claim 1 (which claim 21 depends on) already recites wherein the one or more syringes are configured to introduce the respective therapeutic agent into perfusate contained in the reservoir in lines 10-12.
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 1-6, and 21 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.
Claim 1 recites the limitation "a syringe pump " in lines 9-10. A manifold is a pipe system which distributes either a single input to multiple outputs or multiple inputs to a single output (p. 400 Cambridge Aerospace Dictionary, 2nd Edition), so it does not make sense for a manifold to comprise only one syringe (input) and only one reservoir (output), as a manifold requires either multiple inputs or multiple outputs.
Dependent claims are rejected for the same reason as the base claim(s) upon which they depend.
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, 8-18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Daniele et al. (US 2021/0360913 A1) (already of record) in view of Becker et al. (US 2020/0375178 A1) (already of record) and Hassanein et al. (US 2015/0342177 A1).
Regarding claim 1, Daniele et al. teaches an ex-vivo brain perfusion system for perfusion of a brain (abstract “ex vivo restoration and preservation of an intact mammalian brain… brain perfusion”), the system comprising: a reservoir configured to receive perfusate (Fig. 1A 124 perfusate reservoir); a housing configured to contain the brain (Fig. 1A 102 brain housing unit, 110 brain chamber); an arterial circuit configured to fluidly couple the reservoir to the brain (Fig. 1A 116 arterial loop); a venous circuit fluidly coupling the housing to the reservoir (Fig. 1A 112 venous loop); and a pump fluidly coupled to the reservoir (Fig. 1A 120 venous circulation pump coupled to 118 venous return line coupled to 124 perfusate reservoir) and configured to introduce a therapeutic agent to the perfusate in the reservoir, wherein the ex-vivo brain perfusion system is configured to perfuse the brain with the therapeutic agent to test at least one property of the therapeutic agent (abstract “brain perfusion medium (BPM), which are able to reduce reperfusion injury, stimulate recovery from hypoxia, prevent edema and metabolically support the energy needs of brain function”).
Regarding the limitation “perfuse the brain with the therapeutic agent to test at least one property of the therapeutic agent”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II). Therefore, the apparatus disclosed by Daniele et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be a system for ex vivo restoration and preservation of a brain by perfusion of synthetic brain perfusate formulations which are able to reduce reperfusion injury, stimulate recovery from hypoxia, prevent edema and metabolically support the energy needs of brain function (abstract) and would be structurally capable of perfusing a brain with a therapeutic agent to test at least one property of the therapeutic agent absent clear evidence otherwise.
Daniele et al. does not explicitly teach a syringe pump as required by claim 1 in the instant application, but does teach that the venous circulation pump can be any pump known in the art (para. 0135). Becker et al. teaches that a syringe pump is a known pump in the art (para. 0213). Though Daniele et al. does not explicitly teach a syringe pump, it would have been obvious to a person of ordinary skill in the art to use a syringe pump because the substitution of one known element for another would have yielded predictable results with reasonable expectation that this would result in a system that pumps perfusate to an organ (para. 0134 in Daniele et al., abstract in Becker et al.).
Daniele et al. does not teach an in-line spectroscopy system configured to perform spectroscopy on the perfusate in real-time during a perfusion process. However, Becker et al. teaches a spectroscopic flow cell (para. 0074). Becker et al. teaches that spectroscopy identifies the absence or presence of a molecule of interest (para. 0073). It would have been obvious to a person of ordinary skill in the art to use the Becker et al. configuration of spectroscopic flow cell in Daniele et al.’s device with a reasonable expectation that it would identify the absence or presence of a molecule of interest. This method for improving Daniele et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Becker et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Daniele et al. and Becker et al. to obtain the invention as specified in claim 1.
Regarding the limitation “a stepper motor configured to control movement of a plunger of each syringe of the one or more syringes”, Daniele et al. does not disclose a motor and Becker et al. discloses a linear motor (para. 0054). However, Hassanein et al. teaches that a syringe pump driven by a stepper motor is known in the art (para. 0161). Hassanein et al. teaches that the stepper motor provides the highest torque for a given motor size and is easy to drive (para. 0180). Though neither Daniele et al. nor Becker et al. explicitly teach a stepper motor, it would have been obvious to a person of ordinary skill in the art to use a stepper motor because the substitution of one known element for another would have yielded predictable results with reasonable expectation that this would result in a system that drive a syringe pump to easily drive delivery of fluid with a high torque.
Regarding the limitation “The syringe pump manifold introduces the respective therapeutic agent from the one or more syringes into the perfusate based at least partly on spectroscopy data generated by the in-line spectroscopy system”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II). Therefore, the apparatus disclosed by modified Daniele et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to have a pump (Fig. 1A 120 venous circulation pump) for delivering therapeutic agents to perfusate (abstract “brain perfusion medium (BPM), which are able to reduce reperfusion injury, stimulate recovery from hypoxia, prevent edema and metabolically support the energy needs of brain function”) and a spectroscopic flow cell (para. 0074 of Becker et al.) and would be structurally capable of introducing therapeutic agents into perfusate based at least partly on spectroscopy data absent clear evidence otherwise.
Regarding claim 2, Daniele et al. teaches an ex-vivo brain perfusion system wherein the arterial circuit comprises: a fluid line fluidly coupling the reservoir to the brain (Fig. 1A 144 arterial line); a pressure sensor configured to measure pressure along the fluid line (Fig. 1A 152 sensor; para. 0150 “sensors 152, 154 can detect and report… pressure”); a flow sensor configured to measure a flow rate along the fluid line (Fig. 1A 154 sensor; para. 0150 “sensors 152, 154 can detect and report… flow rate”); and a pulse generation system (Fig. 1A 148 pulse generator) configured to generate pulsatile flow of perfusate from the reservoir to the brain along the fluid line based on one or more signals generated by at least one of the pressure sensor or the flow sensor (para. 0018 “perfuses the brain with the perfusate through the pulse generator”).
Regarding claim 4, Daniele et al. teaches an ex-vivo brain perfusion system wherein the pulse generation system is capable of being controlled based on an internal resistance of the brain detected by the pressure sensor (Fig. 1B 172 pulse generator controller; para. 0150 “sensors 152, 154 can detect and report… pressure”).
Regarding the limitation “the pulse generation system is controlled based on an internal resistance of the brain detected by the pressure sensor”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II). Therefore, the apparatus disclosed by Daniele et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to have a pulse generator controller and a pressure sensor (Fig. 1B 172 pulse generator controller; para. 0150 “sensors 152, 154 can detect and report… pressure”) and would be structurally capable of controlling the pulse generation system based on an internal resistance of the brain detected by the pressure sensor absent clear evidence otherwise.
Regarding claim 5, Daniele et al. teaches an ex-vivo brain perfusion system wherein the pump is capable of introducing the therapeutic agent (abstract “brain perfusion medium (BPM), which are able to reduce reperfusion injury, stimulate recovery from hypoxia, prevent edema and metabolically support the energy needs of brain function”) into the reservoir according to a predefined release profile for the therapeutic agent (para. 0134 “pump perfusate through the venous loop”).
Daniele et al. does not explicitly teach a syringe pump as required by claim 5 in the instant application, but does teach that the venous circulation pump can be any pump known in the art (para. 0135). Becker et al. teaches that a syringe pump is a known pump in the art (para. 0213). Though Daniele et al. does not explicitly teach a syringe pump, it would have been obvious to a person of ordinary skill in the art to use a syringe pump because the substitution of one known element for another would have yielded predictable results with reasonable expectation that this would result in a system that pumps perfusate to an organ (para. 0134 In Daniele et al., abstract in Becker et al.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the pump teachings of Daniele et al. with the teachings of Becker et al. to obtain the invention as specified in claim 5.
Regarding claim 6, Daniele et al. teaches an ex-vivo brain perfusion system further comprising a filtration system configured to filter the perfusate (Fig. 1A 114 filtration loop, 134 hemodiafiltration unit), wherein the filtration system comprises: a dialyzer (Fig. 1A 134 hemodiafiltration unit; para. 0140 “hemodiafiltration unit 134 is a capillary dialyzer”) comprising an inlet port (Fig. 1A piping at 136 junction connected to 134 hemodiafiltration unit) and an outlet port (Fig. 1A piping at opposite end of 134 hemodiafiltration unit), the dialyzer configured to filter the perfusate (para. 0140 “hemodiafiltration unit 134 is adapted and configured to remove metabolic waste products from the perfusate”); an inlet line fluidly coupling the reservoir to the inlet port (Fig. 1A line connecting 124 perfusate reservoir to 130 filtration circulation pump which is connected to 132 heat exchanger connected to 134 hemodiafiltration unit); an outlet line fluidly coupling the outlet port to the reservoir (Fig. 1A line at opposite end of 134 hemodiafiltration unit from 136 connected to 124 perfusate reservoir); and a pump configured to pump perfusate from the reservoir through the dialyzer (Fig. 1A 130 filtration circulation pump).
Regarding claim 8, Daniele et al. teaches an ex-vivo brain perfusion system comprising a heat exchanger configured to control temperature of perfusate (para. 0014 “heat exchange unit adapted and configured to regulate the temperature of the brain enclosure unit and the perfusion loop”), but does not teach an in-line spectroscopy system comprising a spectroscopy chamber configured to receive perfusate from the reservoir or the venous circuit; and a spectrometer configured to perform spectroscopy on perfusate in the spectroscopy chamber. However, Becker et al. teaches a spectroscopic flow cell (para. 0074) and a spectrometer (para. 0080 “UV-VIS spectrometer”). Becker et al. teaches that spectroscopy identifies the absence or presence of a molecule of interest (para. 0073).
It would have been obvious to a person of ordinary skill in the art to use the Becker et al. configuration of spectroscopic flow cell and a UV-VIS spectrometer in Daniele et al.’s device with a reasonable expectation that it would identify the absence or presence of a molecule of interest. This method for improving Daniele et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Becker et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Daniele et al. and Becker et al. to obtain the invention as specified in claim 8.
Regarding claim 9, Daniele et al. teaches an ex-vivo brain perfusion system wherein the pump is capable of introducing the therapeutic agent into the reservoir (para. 0134), but does not teach a spectroscopy system. However, Becker et al. teaches a spectroscopy system (para. 0074 “spectroscopic flow cell”) wherein: the in-line spectroscopy system is configured to perform spectroscopy on one or more perfusate samples from the reservoir (para. 0073).
It would have been obvious to a person of ordinary skill in the art to use the Becker et al. configuration of spectroscopic flow cell in Daniele et al.’s device with a reasonable expectation that it would identify the absence or presence of a molecule of interest. This method for improving Daniele et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Becker et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Daniele et al. and Becker et al. to obtain the invention as specified in claim 9.
Regarding the limitation “according to a predefined release profile for the therapeutic agent based on spectroscopy data generated by performing spectroscopy on one or more perfusate samples from the reservoir using the in-line spectroscopy system”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II). Therefore, the apparatus disclosed by modified Daniele et al. would be fully capable of achieving every claimed intended use because the apparatus of Becker et al. is disclosed to have a spectroscopic flow cell (para. 0074) and would be structurally capable of generating spectroscopy data on one or more perfusate samples absent clear evidence otherwise.
Regarding claim 10, Daniele et al. teaches an ex-vivo brain perfusion system wherein: the system further comprises a filtration system (Fig. 1A 114 filtration loop, 134 hemodiafiltration unit) capable of filtering the therapeutic agent out of the perfusate (para. 0014 “hemodiafiltration unit adapted and configured to remove metabolic toxins from and add nutrients to the perfusate”). Daniele et al. does not teach a spectroscopy system; however, Becker et al. teaches a spectroscopic flow cell (para. 0074) and that spectroscopy identifies the absence or presence of a molecule of interest (para. 0073).
It would have been obvious to a person of ordinary skill in the art to use the Becker et al. configuration of spectroscopic flow cell in Daniele et al.’s device with a reasonable expectation that it would identify the absence or presence of a molecule of interest. This method for improving Daniele et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Becker et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Daniele et al. and Becker et al. to obtain the invention as specified in claim 10.
Regarding the limitation “according to a predefined release profile for the therapeutic agent based on spectroscopy data generated by performing spectroscopy on one or more perfusate samples from the reservoir using the in-line spectroscopy system”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II). Therefore, the apparatus disclosed by modified Daniele et al. would be fully capable of achieving every claimed intended use because the apparatus of Becker et al. is disclosed to have a spectroscopic flow cell (para. 0074) and would be structurally capable of generating spectroscopy data on one or more perfusate samples absent clear evidence otherwise.
Regarding claim 11, Daniele et al. teaches an ex-vivo brain perfusion system, but does not teach a spectroscopy system. However, Becker et al. teaches a spectroscopic flow cell (para. 0074) wherein the in-line spectroscopy system is configured to perform spectroscopy on one or more perfusate samples collected from the venous circuit to test the at least one property of the therapeutic agent (para. 0074 “spectroscopy of at least one compound/molecule present in the perfusate”). Becker et al. teaches that spectroscopy identifies the absence or presence of a molecule of interest (para. 0073).
It would have been obvious to a person of ordinary skill in the art to use the Becker et al. configuration of spectroscopic flow cell in Daniele et al.’s device with a reasonable expectation that it would identify the absence or presence of a molecule of interest. This method for improving Daniele et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Becker et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Daniele et al. and Becker et al. to obtain the invention as specified in claim 11.
Regarding claim 12, Daniele et al. teaches an ex-vivo brain perfusion system wherein the at least one property of the therapeutic agent comprises whether the therapeutic agent passes through a blood-brain barrier of the brain (para. 0120).
Regarding claim 13, Daniele et al. teaches an ex-vivo brain perfusion system, but does not teach a spectroscopy system. However, Becker et al. teaches a spectroscopic flow cell (para. 0074) configured to perform Raman spectroscopy on the perfusate (para. 0074 “Raman spectroscopy”). Becker et al. teaches that spectroscopy identifies the absence or presence of a molecule of interest (para. 0073).
It would have been obvious to a person of ordinary skill in the art to use the Becker et al. configuration of spectroscopic flow cell in Daniele et al.’s device with a reasonable expectation that it would identify the absence or presence of a molecule of interest. This method for improving Daniele et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Becker et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Daniele et al. and Becker et al. to obtain the invention as specified in claim 13.
Regarding claim 14, Daniele et al. teaches an ex-vivo brain perfusion system comprising sensors for measuring pH, dissolved oxygen concentration, dissolved carbon dioxide concentration, dissolved metabolite concentration, temperature, pressure, and flow rate (para. 0014), but does not teach a spectroscopy probe coupled to the housing, wherein the spectroscopy probe is configured to perform spectroscopy on tissue of the brain in the housing. However, Becker et al. teaches a sensor for continuously recording spectra (para. 0073). Becker et al. teaches that spectroscopy identifies the absence or presence of a molecule of interest (para. 0073).
It would have been obvious to a person of ordinary skill in the art to use the Becker et al. configuration of a sensor that records spectra in Daniele et al.’s device with a reasonable expectation that it would identify the absence or presence of a molecule of interest. This method for improving Daniele et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Becker et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Daniele et al. and Becker et al. to obtain the invention as specified in claim 14.
Regarding claim 15, Daniele et al. teaches an ex-vivo brain perfusion system, but does not teach a spectroscopy probe. However, Becker et al. teaches a spectroscopy sensor (para. 0073 “sensor”) capable of determining at least one property of the therapeutic agent based on spectroscopy data generated by performing spectroscopy on the brain using the spectroscopy probe (para. 0073 “spectroscopy of a liquid solution can identify the absence or presence of the molecule of interest”).
It would have been obvious to a person of ordinary skill in the art to use the Becker et al. configuration of a sensor that records spectra in Daniele et al.’s device with a reasonable expectation that it would identify the absence or presence of a molecule of interest. This method for improving Daniele et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Becker et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Daniele et al. and Becker et al. to obtain the invention as specified in claim 15.
Regarding claim 16, Daniele et al. teaches an ex-vivo brain perfusion system, but does not teach a spectroscopy system with a spectroscopy probe. However, Becker et al. teaches a spectroscopic flow cell (para. 0074) configured to perform Raman spectroscopy (para. 0074 “Raman spectroscopy”). Becker et al. teaches that spectroscopy identifies the absence or presence of a molecule of interest (para. 0073). Becker et al. also teaches a spectroscopy sensor (para. 0073 “sensor”) capable of preforming Raman spectroscopy of the tissue of the brain (para. 0073 “spectroscopy of a liquid solution can identify the absence or presence of the molecule of interest”).
It would have been obvious to a person of ordinary skill in the art to use the Becker et al. configuration of spectroscopic flow cell/sensor in Daniele et al.’s device with a reasonable expectation that it would identify the absence or presence of a molecule of interest. This method for improving Daniele et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Becker et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Daniele et al. and Becker et al. to obtain the invention as specified in claim 16.
Regarding claim 17, Daniele et al. teaches an ex-vivo brain perfusion system wherein the at least one property of the therapeutic agent is a pharmacodynamic property of the therapeutic agent or a pharmacokinetic property of the therapeutic agent (para. 0048 “pharmacological… interventions”; para. 0210).
Regarding claim 18, Daniele et al. teaches an ex-vivo brain perfusion system wherein the at least one property of the therapeutic agent is an ability of the therapeutic agent to pass through a blood-brain barrier of the brain (para. 0120).
Regarding claim 21, Daniele et al. teaches a pump fluidly coupled to a reservoir (Fig. 1A 120 venous circulation pump coupled to 118 venous return line coupled to 124 perfusate reservoir) and configured to introduce a therapeutic agent to the perfusate in the reservoir (abstract “brain perfusion medium (BPM), which are able to reduce reperfusion injury, stimulate recovery from hypoxia, prevent edema and metabolically support the energy needs of brain function”). Daniele et al. does not explicitly teach a syringe; however, Becker et al. teaches that a syringe pump is a known pump in the art (para. 0213). Though Daniele et al. does not explicitly teach a syringe pump, it would have been obvious to a person of ordinary skill in the art to use a syringe pump because the substitution of one known element for another would have yielded predictable results with reasonable expectation that this would result in a system that pumps perfusate to an organ (para. 0134 in Daniele et al., abstract in Becker et al.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the teachings of Daniele et al. with the teachings of Becker et al. to obtain the invention as specified in claim 1.
It is to be noted that claim 21 does not specify a further structural limitation of the subject matter claimed in claim 1, which claim 21 depends on.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Daniele et al. (US 2021/0360913 A1) (already of record) in view of Becker et al. (US 2020/0375178 A1) (already of record) and Hassanein et al. (US 2015/0342177 A1) as applied to claim 2 above, and further in view of Faulkner et al. (2009/0087328 A1) (already of record).
Regarding claim 3, Daniele et al. teaches an ex-vivo brain perfusion system wherein the pulse generation system comprises: a pulse generator (Fig. 1A 148 pulse generator) comprising: a housing (Fig. 1A 148); a housing inlet (Fig. 1A locations where 116 arterial loop connects to 148 pulse generator housing); and an air supply system fluidly coupled to the housing inlet of the pulse generator (Fig. 1B 174 air source, 176 pressure regulator, 172 pulse generator controller, 186 pressure line).
Regarding the limitation “the air supply system is configured to provide pressurized air into the housing inlet of the pulse generator based on one or more signals generated by at least one of the pressure sensor or the flow sensor”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II). Therefore, the apparatus disclosed by Daniele et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to have an air supply system (Fig. 1B 174 air source, 176 pressure regulator, 172 pulse generator controller, 186 pressure line) in communication with the pulse generator (para. 0171), and sensors (para. 0150 “sensors 152, 154 can detect and report… flow rate… pressure”), and would be structurally capable of providing pressurized air into the housing of the pulse generator based on one or more signals generated by at least one of the pressure sensor or the flow sensor absent clear evidence otherwise.
Modified Daniele et al. does not teach a pulse generator comprising a flexible diaphragm, however, Faulkner et al. teaches this feature (para. 0068). Faulkner et al. teaches that the inward motion of the diaphragm increases the pressure in the fluid flowing through the pulse generator, and outward motion of the diaphragm decreases the pressure (para. 0068). It would have been obvious to a person of ordinary skill in the art to use the Faulkner et al. configuration of a flexible diaphragm in modified Daniele et al.’s device with a reasonable expectation that the inward and outward motion of the diaphragm would increase and decrease the pressure of the fluid flowing through the pulse generator. This method for improving modified Daniele et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Faulkner et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Daniele et al. and Faulkner et al. to obtain the invention as specified in claim 3.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LOPEZLIRA whose telephone number is (703)756-5517. The examiner can normally be reached Mon - Fri: 8:30-5:00.
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799