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
The amendments filed on 11/20/2025 has been entered. Claims 1-15 have been amended; claim 16 has been cancelled. Accordingly, claims 1-16 are pending and under consideration.
Applicant’s amendments to the claims have overcome each and every 35. U.S.C. 112(b) rejection previously set forth in the Non-final Office action mailed on 08/25/2025. Therefore, all 35 U.S.C. 112(b) rejections are hereby withdrawn.
However, the amendment invokes new 35 U.S.C. 112(b) rejections. See rejection of claims below.
Response to Arguments
Applicant's arguments filed on 11/20/2025 have been fully considered but they are not persuasive.
In response to applicant's argument that both Gremel and Mathrewson fails to provide any teaching or suggestion of converting a dialyzer to a membrane gas exchanger as traversed on page 6-8 of Applicant’s remarks, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114.II and rejection of claims below.
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 1-16 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 "the membrane gas exchanger" in line 6-7. There is insufficient antecedent basis for this limitation in the claim. It is also unclear to Examiner whether the limitation of “a membrane gas exchanger” in the last line the same as “the membrane gas exchanger” in line 6-7. For examining purposes, Examiner currently interprets “the membrane gas exchanger” as the “membrane exchanger” recited in the preamble.
Accordingly, claims 2-16 are rejected due to dependency on claim 1.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 1, 2, 4, 6, 8, 12, 13, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Gremel US 5,788,287 A (previously cited, hereinafter Gremel), as evidenced by Mathewson et al. US 5,236,665 A (previously cited, hereinafter Mathewson).
Regarding claim 1, Gremel discloses a membrane exchanger 2 (Fig. 1 – oxygenator 2) comprising:
a housing (see annotated Fig. 1 below) and in which a first chamber (Col. 1, line 31-32 – “individual fibers in fiber bundle 4 are surrounded by blood taken from a patient”, and Col. 1, line 41-43 – “The typical oxygenator 2 operates by diffusing oxygen from gas in the interior passages of fibers in fiber bundle 4 through the walls of the fibers into the blood”; thus, the first chamber being the exterior of the fiber bundle 4) and a second chamber (Col. 1, line 52 – “the interior of the fibers”) as well as a membrane 4 (Fig. 1 – fiber bundle 4) are arranged (Fig. 1),
wherein the membrane 4 (Fig. 1) is gas permeable (Col. 1, line 41-43 – “The typical oxygenator 2 operates by diffusing oxygen from gas in the interior passages of fibers in fiber bundle 4 through the walls of the fibers into the blood”, and Col. 1, line 44-45 – “The fibers of fiber bundle 4 are relatively porous to diffusion of oxygen and carbon dioxide across the walls of the individual fibers”) and liquid impermeable (Col. 1, line 31-33 – “The blood… is pumped through the oxygenator 2 over the fibers”; Examiner contends that it is well-known that the fiber bundles in extracorporeal oxygenation allow diffusion of gas, such as oxygen, rather than blood components) and separates the first chamber and the second chamber from one another (Col. 1, line 26-35, the interior of fiber bundles 4 are for gas while the outside of the fiber bundles are for blood),
the first chamber forms the blood side (Col. 1, line 31-32 – “individual fibers in fiber bundle 4 are surrounded by blood taken from a patient”, so the exterior of the fiber bundles form a blood side) and the second chamber forms the gas side (Col. 1, line 41-43 – “The typical oxygenator 2 operates by diffusing oxygen from gas in the interior passages of fibers in fiber bundle 4) of the membrane gas exchanger 2 (Fig. 1; see 112(b) rejection above),
the first chamber (Col. 1, line 31-32, and as established above – the exterior of fiber bundle 4) has a blood inlet (Fig. 1 – “blood in”) and a blood outlet (Fig. 1 – “blood out”),
the second chamber (Col. 1, line 41-43, and as established above – the interior of fiber bundle 4) has a gas inlet 6 (Fig. 1 – inlet manifold 6, and Col. 1, line 63-64 – “An inlet manifold 6 at one end of the fiber bundle 4”) and a gas outlet 10 (Fig. 1 – outlet manifold 10, Col. 2, line 1-2 – “An outlet manifold 10 is located at the end of the fiber bundle 4 opposite inlet manifold”),
the blood inlet (Fig. 1 – “blood in”), the blood outlet (Fig. 1 – “blood out”), the gas inlet (Fig. 1 – “O2 in”), and the gas outlet (Fig. 1 – “CO2 out”) are arranged at the housing (see annotated Fig. 1 below); and
a first adapter 20 (Fig. 6 – outlet connector 20) comprising an inlet (see annotated Fig. 5 below) and at least two outlets 28, O (see annotated Fig. 5 below – hole 28, and annotated outlet O), wherein
the first adapter 20 (Fig. 6) is connected to the gas outlet 10 (Fig. 1) of the housing (Fig. 5-6).
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Annotated Fig. 1 of Gremel
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Annotated Fig. 5 of Gremel
However, Gremel does not explicitly disclose the housing is the housing of a dialyzer; and wherein the dialyzer is converted to a membrane gas exchanger.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized that the housing structure of Gremel’s device, specifically with a blood inlet, blood outlet, a gas inlet, and a gas outlet, is well-known for use in both dialysis and oxygenation. Evidently, the housing shown in Fig. 7 of Mathewson with ports relate to both dialyzers, and membrane oxygenators (Col. 1, line 16-17 of Mathewson). Furthermore, under broadest reasonable interpretation, the structure of Gremel’s housing can still be used in dialyzer since one of ordinary skill in the art would have had the capability to recognize that the fundamental ports for blood and supplemental fluids are structurally arranged/configured in a greatly similar fashion. Said limitations are mere intended use of a device. MPEP 2114 discusses "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). 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”. In this case, one of ordinary skill in the art would have had the technological capability and found it obvious to recognize that when the device is coupled to a fluid source, i.e. dialysate source, the device becomes a fluid-fluid interface; whereas when the device is coupled to a gas source as intended in the claimed invention, the device then becomes a gas-fluid interface.
Regarding claim 2, Gremel discloses the invention of claim 1. However, Gremel does not disclose wherein the first adapter is releasably connected to the gas outlet.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first adapter of Gremel such that it is releasably connected to the gas outlet, as the Courts have held that making known elements separable is within the skill of a person of ordinary skill in the art. See In re Dulberg, 129 USPQ 348 (CCPA 1961) (see MPEP § 2144.04).
Regarding claim 4, Gremel discloses the invention of claim 1. Gremel further discloses wherein the membrane 4 (Fig. 1) is present as a hollow fiber bundle (Col. 1, line 41-43 The typical oxygenator 2 operates by diffusing oxygen from gas in the interior passages of fibers in fiber bundle 4”; since oxygen enters the interior passages of fibers in fiber bundle 4, it implies that the fiber bundle 4 is hollow).
Regarding claim 6, Gremel discloses the invention of claim 1. Gremel further discloses further comprising a second adapter 8 (Fig. 1 – inlet connector 8) connected to the gas inlet 6 (Fig. 1).
Regarding claim 8, Gremel discloses the invention of claim 6. Gremel further discloses wherein the second adapter 8 (Fig. 1) is differently designed than the first adapter 20 (Fig. 6; the structure of outlet connector 20 is depicted with openings).
Regarding claim 12, Gremel discloses the invention of claim 1. Gremel further discloses a device for extracorporeal membrane oxygenation (Col. 1, line 14 – “an extra-corporeal system that adds oxygen”) that is connected to the blood inlet (Fig. 1 – “blood in”) and blood outlet (Fig. 1 – “blood out”) of a membrane exchanger 2 (Fig. 1, and Col. 1, line 29-35 – “in the extra-corporeal circuit… The blood is removed from the venous side of a patient and is pumped through the oxygenator 2 over the fibers and is then infused into the patient's arterial side”) in accordance with claim 1 (see rejection of claim 1 above).
Regarding claim 13, Gremel discloses the invention of claim 12. Gremel further discloses further comprising a second adapter 8 (Fig. 1 – inlet connector 8) connect to the gas inlet 6 (Fig. 1) and the second adapter 8 (Fig. 1) is connected to an oxygen source (Col. 1, line 65-67 – “Inlet manifold 6 has an inlet connector 8 for connecting the inlet manifold 6 to the source of oxygen rich gas”).
Regarding claim 14, Gremel discloses the invention of claim 12. However, Gremel does not currently disclose further discloses wherein the first adapter of the membrane exchanger is connected to a CO2 discharge.
Gremel, in another embodiment, teaches the first adapter 12 (Fig. 2 – outlet connector 12) is connected to a CO2 discharge (Fig. 1 – “CO2 out”, and Col. 2, line 13-17 – “gas can flow out of outlet manifold 10 through the hollow outlet connector 12 and through the interior of the tubing 14 to the waste gas receptacle”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first adapter of Gremel to further have it connected to a carbon dioxide discharge, also as taught by Gremel, as Gremel teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Regarding claim 15, Gremel discloses a method of using a oxygenator housing (see annotated Fig. 1 above) for a membrane gas exchanger 2 (Fig. 1 – oxygenator 2; oxygenator 2 has the annotated housing) in a device for extracorporeal membrane oxygenation (Col. 1, line 14 – “an extra-corporeal system that adds oxygen”), comprising:
connecting an inlet (see annotated Fig. 5 above) of a first adapter 20 (Fig. 6 – outlet connector 20) to a gas outlet 10 (Fig. 1 – outlet manifold 10) of the housing (see annotated Fig. 1 above), wherein the first adapter 20 (Fig. 6) comprises the inlet (see annotated Fig. 5 above) and at least two outlets 28, O (see annotated Fig. 5 above – hole 28, and annotated outlet O).
However, Gremel does not disclose using a dialyzer housing.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized that the housing structure of Gremel’s device, specifically with a blood inlet, blood outlet, a gas inlet, and a gas outlet, is well-known for use in both dialysis and oxygenation. Evidently, the housing shown in Fig. 7 of Mathewson with ports relate to both dialyzers, and membrane oxygenators (Col. 1, line 16-17 of Mathewson). Furthermore, under broadest reasonable interpretation, the structure of Gremel’s housing can still be used in dialyzer since one of ordinary skill in the art would have had the capability to recognize that the fundamental ports for blood and supplemental fluids are structurally arranged/configured in a greatly similar fashion; and a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, one of ordinary skill in the art would have had the technological capability and found it obvious to recognize that when the device is coupled to a fluid source, i.e. dialysate source, the device becomes a fluid-fluid interface; whereas when the device is coupled to a gas source as intended in the claimed invention, the device then becomes a gas-fluid interface.
Claims 3, 7, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Gremel as applied to claim 1 and claim 6 above, and further in view of Haag et al. US 2014/0228815 A1 (previously cited, hereinafter Haag).
Regarding claim 3, Gremel discloses the invention of claim 1. However, Gremel does not disclose wherein the first adapter is plugged onto the gas outlet.
Haag, in the same field of endeavor of coupling device in extracorporeal blood circuits (Par. 3), teaches the adapter 10 (Fig. 7 – coupling device 10) is plugged onto the conduit 32 (Fig. 7 – separate conduit 32).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first adapter of Gremel to have it plug onto the conduit/outlet as taught by Haag, in order to provide a quick-release coupling system (Par. 84 of Haag). Furthermore, the Courts have held that making known elements separable is within the skill of a person of ordinary skill in the art. See In re Dulberg, 129 USPQ 348 (CCPA 1961) (see MPEP § 2144.04).
Regarding claim 7, Gremel discloses the invention of claim 6. However, Gremel does not disclose wherein the second adapter is releasably connected to the gas inlet.
Haag, in the same field of endeavor of coupling device in extracorporeal blood circuits (Par. 3), teaches the adapter 10 (Fig. 7 – coupling device 10) is releasably connected to the conduit 32 (Fig. 7 – separate conduit 32).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second adapter of Gremel to have it releasably connected the conduit/inlet as taught by Haag, in order to provide a quick-release coupling system (Par. 84 of Haag). Furthermore, the Courts have held that making known elements separable is within the skill of a person of ordinary skill in the art. See In re Dulberg, 129 USPQ 348 (CCPA 1961) (see MPEP § 2144.04).
Regarding claim 9, Gremel discloses the invention of claim 6. However, Gremel does not disclose wherein the first adapter and/or the second adapter has/have a quick-closure connection for coupling to the gas outlet or to the gas inlet.
Haag, in the same field of endeavor of coupling device in extracorporeal blood circuits (Par. 3), teaches the adapter 10 (Fig. 7 – coupling device 10) has a quick-closure connection for coupling to the conduit 32 (Fig. 7 – separate conduit 32, and Par. 84 – “The coupling device 10 is preferably configured as a quick-release coupling device generally useful for connecting two or more conduits 32”; Examiner notes that Par. 23 of Applicant’s PG-PUB discusses a quick-closure connection as the ability to snap onto the conduit; thus, Haag’s teaching is consistent with Applicant’s description and thus the limitation is met).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first or second adapter of Gremel to be a quick-closure connection as taught by Haag, in order to provide useful connection with two or more conduits (Par. 84 of Haag).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Gremel as applied to claim 1 above, and further in view of Matloff et al. US 3,692,648 A (previously cited, hereinafter Matloff).
Regarding claim 5, Gremel discloses the invention of claim 1. Gremel further discloses wherein the membrane 4 (Fig. 1) has a base body 4 (Fig. 1).
However, Gremel does not explicitly disclose a liquid impermeable coating located thereon.
Matloff, in the same field of endeavor of oxygenating blood apparatus (Title), teaches the membrane 14 (Fig. 1 – membrane 14) has a liquid impermeable coating located thereon (Col. 5, line 48-62 – “…the side of the membrane… may be coated with an oxygen-permeable coating. Moreover, the coating need not be a "diffusion" type barrier, but can be a microporous barrier having a very large permeability to gas, although providing a substantially impermeable barrier to the flow of liquid generally or blood in particular”).
Given that the membrane/fiber bundle 14 of Gremel is gas permeable and liquid impermeable as established in claim 1, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the membrane of Gremel to have a liquid impermeable coating as taught by Matloff, in order to further prevent the flow of liquid, such as blood (Col. 5, line 60-62 of Matloff).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Gremel as applied to claim 1 above, and further in view of Pleiner et al. US 2023/0293788 A1 (previously cited, hereinafter Pleiner).
Regarding claim 10, Gremel discloses the invention of claim 1. However, Gremel does not currently disclose wherein the first adapter further comprises a gas sample outlet.
Pleiner, in the same field of endeavor of tubing of a blood treatment apparatus (Title), teaches the first adapter 2000 (Fig. 1 – tube insert 2000) comprises a sample outlet 2011 (Fig. 1 – secondary line 2011, and Par. 83 – “The secondary line 2011 serves to enable taking a sample of the liquid”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first adapter of Gremel to further have a sample outlet as taught by Pleiner, in order to take samples whose compositions are of interest during extracorporeal blood treatment (Par. 3 of Pleiner).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gremel as applied to claim 1 above, and further in view of Palti US 2020/0055001 A1 (previously cited, hereinafter Palti), evidenced by Oda US 2021/0015985 A1 (previously cited, hereinafter Oda).
Regarding claim 11, Gremel discloses the invention of claim 1. However, Gremel does not disclose wherein the first adapter further comprises an outflow for condensed water.
Palti, in the same field of endeavor of gas exchanger (Fig. 8), teaches an outflow for condensed water (Fig. 8 – “Gas out” to “water condensation subsystem” + ”water container”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first adapter of Gremel to have an outflow for condensed water, as taught by Palti, in order to collect moisture in the gas into liquid water (Par. 83 of Palti). As evidenced by Oda, condensed water within the oxygenator can increase the resistance to gas flow and reduce the heating area of the outlet (Par. 4 of Oda). Therefore, having an outflow for condensed water will increase gas exchange in oxygenator.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Gremel as applied to claim 1, and further in view of Pleiner and Palti, evidenced by Oda.
Regarding claim 16, Gremel suggests the invention of claim 1. However, Gremel does not disclose wherein the first adapter further comprises a gas sample outlet and an outflow for condensed water.
Pleiner, in the same field of endeavor of tubing of a blood treatment apparatus (Title), teaches the first adapter 2000 (Fig. 1 – tube insert 2000) comprises a sample outlet 2011 (Fig. 1 – secondary line 2011, and Par. 83 – “The secondary line 2011 serves to enable taking a sample of the liquid”).
Palti, in the same field of endeavor of gas exchanger (Fig. 8), teaches an outflow for condensed water (Fig. 8 – “Gas out” to “water condensation subsystem” + ”water container”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first adapter of Gremel to further have a sample outlet as taught by Pleiner, in order to take samples whose compositions are of interest during extracorporeal blood treatment (Par. 3 of Pleiner).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first adapter of Gremel in view of Pleiner to have an outflow for condensed water, as taught by Palti, in order to collect moisture in the gas into liquid water (Par. 83 of Palti). As evidenced by Oda, condensed water within the oxygenator can increase the resistance to gas flow and reduce the heating area of the outlet (Par. 4 of Oda). Therefore, having an outflow for condensed water will increase gas exchange in oxygenator.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tepic et al. US 5851985 A
Trudell et al. US 5474740 A
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 QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781