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 .
Claims 1-20 are pending in the instant application and are examined on the merits herein.
Priority
The instant application is a continuation of 16/612,211 filed 11/08/2019 which is a 371 of PCT/IB17/53229 filed 06/01/2017.
Claims 1-20 receive priority to the prior-filed application, filed on 06/01/2017.
Specification
The disclosure is objected to because of the following informalities:
The gas exchanger is referred to by an incorrect reference number (para. 0035).
Appropriate correction is required.
Claim Interpretation
The claims require an insulating chamber configured to receive insulating fluid. This is interpreted to be any chamber of the oxygenator comprising fluid that may allow for heat exchange with another portion of the oxygenator.
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 1-20 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.
Claims 1 and 12 recite the limitation "a heat exchanger disposed within the housing, the heat exchanger including a heat-exchange fluid inlet, a heat-exchange fluid outlet, and a bundle of gas-exchange fibers through which a heat-exchange fluid is configured to flow from a fluid inlet end of the bundle of heat-exchange fibers to a fluid outlet end of the bundle of heat-exchange fibers" in ln. 5-9. This limitation is indefinite in that it is unclear how heat-exchange fluid is flowing through a bundle of gas-exchange fibers, such that the heat-exchange fluid flows from a fluid inlet to a fluid outlet of a bundle of heat-exchange fibers. For the sake of compact prosecution, the examiner is treating the claims as though they read “a heat exchanger disposed within the housing, the heat exchanger including a heat-exchange fluid inlet, a heat-exchange fluid outlet, and a bundle of heat-exchange fibers through which a heat-exchange fluid is configured to flow from a fluid inlet end of the bundle of heat-exchange fibers to a fluid outlet end of the bundle of heat-exchange fibers”.
Claims 2-11 and 13-20 are rejected for depending upon rejected base claims.
Claim Rejections - 35 USC § 102
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 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 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.
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Ex. Fig. 1 of Leonard Fig. 4
Claims 1, 3-10, 12, and 13-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent no. 6,113,782 A to Leonard.
Regarding claim 1, Leonard discloses an oxygenator configured to oxygenate blood flowing therethrough (Fig. 4; col. 3 ln. 54-67 and col. 4 ln. 1-3), the oxygenator comprising: a housing (Fig. 4) having a blood inlet (20) and a blood outlet (22), the blood inlet and the blood outlet in fluid communication with an interior of the housing (Fig. 4).
Leonard also discloses a heat exchanger disposed within the housing (col. 6 ln. 66-67 and col. 7 ln. 1-25), the heat exchanger including a heat-exchange fluid inlet (28), a heat-exchange fluid outlet (30), and a bundle of heat-exchange fibers through which a heat-exchange fluid is configured to flow from a fluid inlet end of the bundle of heat-exchange fibers to a fluid outlet end of the bundle of heat-exchange fibers (52).
Leonard further discloses a gas exchanger disposed within the housing (col. 6 ln. 34-65), the gas exchanger including a gas-exchange fluid inlet (24), a gas-exchange fluid outlet (26), and a bundle of gas-exchange fibers through which a gas-exchange fluid is configured to flow from a gas inlet end of the bundle of gas-exchange fibers to a gas outlet end of the bundle of gas-exchange fibers (44); and an insulating chamber configured to receive an insulating fluid to thermally insulate at least the gas outlet end of the bundle of gas-exchange fibers proximate the gas-exchange fluid outlet (Ex. Fig. 1, insulating chambers including insulating chamber (66) configured to receive heat-exchange fluid, insulating chamber (62) configured to receive gas, and third insulating fluid chamber configured to receive blood; col. 4 ln. 53-59; col. 6 ln. 34-65 and col. 7 ln. 1-25).
Regarding claim 3, Leonard discloses the invention of claim 1, Leonard further discloses: wherein the oxygenator includes an insulating fluid inlet and an insulating fluid outlet configured to facilitate circulation of the insulating fluid through the insulating chamber (Ex. Fig. 1, insulating chambers including insulating chamber (66) including insulating fluid inlet and insulating fluid outlets at the fluid inlet end of heat-exchange fibers (52), insulating chamber (62) including insulating fluid inlets at the fluid outlet end of gas-exchange fibers (44), and third insulating fluid chamber including insulating fluid inlet and insulating fluid outlet; col. 4 ln. 53-59; col. 6 ln. 34-65 and col. 7 ln. 1-25).
Regarding claim 4, Leonard discloses the invention of claim 3, Leonard further discloses: wherein the insulting chamber is configured to receive a portion of the heat-exchange fluid from the heat exchanger as the insulating fluid (Ex. Fig. 1, insulating chamber (66) including insulating fluid inlet at end of heat-exchanger fluid inlet (28); col. 6 ln. 34-65 and col. 7 ln. 1-25).
Regarding claim 5, Leonard discloses the invention of claim 1, Leonard further discloses: wherein the insulating fluid is a fluid other than blood flowing through the oxygenator (Ex. Fig. 1, insulating chambers including insulating chamber (66) configured to receive heat-exchange fluid, insulating chamber (62) configured to receive gas; col. 6 ln. 34-65 and col. 7 ln. 1-25).
Regarding claim 6, Leonard discloses the invention of claim 1, Leonard further discloses: wherein ends of the heat-exchange fibers are embedded in a potting material (38b-c; col. 7 ln. 26-31).
Regarding claim 7, Leonard discloses the invention of claim 1, Leonard further discloses: wherein ends of the gas-exchange fibers are embedded in a potting material (38a and 38d; col. 7 ln. 26-31).
Regarding claim 8, Leonard discloses the invention of claim 1, Leonard further discloses: wherein at least a portion of the insulating chamber is disposed radially outward of the potting material upstream of the gas outlet end of the gas-exchange fibers (Ex. Fig. 1, third insulating fluid chamber configured to receive blood; col. 4 ln. 53-59).
Regarding claim 9, Leonard discloses the invention of claim 1, Leonard further discloses: wherein the heat-exchange fibers are woven into mats arranged in a criss-cross configuration (Fig. 3; col. 5 ln. 45-64).
Regarding claim 10, Leonard discloses the invention of claim 1, Leonard further discloses: wherein the gas-exchange fibers are woven into mats arranged in a criss-cross configuration (Fig. 3; col. 5 ln. 45-64).
Regarding claim 12, Leonard discloses an oxygenator configured to oxygenate blood flowing therethrough (Fig. 4; col. 3 ln. 54-67 and col. 4 ln. 1-3), the oxygenator comprising: a housing (Fig. 4) having a blood inlet (20) and a blood outlet (22), the blood inlet and the blood outlet in fluid communication with an interior of the housing (Fig. 4).
Leonard also discloses a heat exchanger disposed within the housing (col. 6 ln. 66-67 and col. 7 ln. 1-25), the heat exchanger including a heat-exchange fluid inlet (28), a heat-exchange fluid outlet (30), and a bundle of heat-exchange fibers through which a heat-exchange fluid is configured to flow from a fluid inlet end of the bundle of heat-exchange fibers to a fluid outlet end of the bundle of heat-exchange fibers.
Leonard further discloses a gas exchanger disposed within the housing (col. 6 ln. 34-65), the gas exchanger including a gas-exchange fluid inlet (24), a gas-exchange fluid outlet (26), and a bundle of gas-exchange fibers through which a gas-exchange fluid is configured to flow from a gas inlet end of the bundle of gas-exchange fibers to a gas outlet end of the bundle of gas-exchange fibers (44); and an insulating chamber configured to receive an insulating fluid therein, the chamber in fluid communication with an insulating fluid inlet and an insulating fluid outlet, such that the insulating fluid is configured to flow through the insulating chamber from the insulating fluid inlet to the insulating fluid outlet (Ex. Fig. 1, insulating chambers including insulating chamber (66) including insulating fluid inlet and insulating fluid outlets at the fluid inlet end of heat-exchange fibers (52) configured to receive heat-exchange fluid, insulating chamber (62) including insulating fluid inlets at the fluid outlet end of gas-exchange fibers (44) configured to receive gas, and third insulating fluid chamber including insulating fluid inlet and insulating fluid outlet configured to receive blood; col. 4 ln. 53-59; col. 6 ln. 34-65 and col. 7 ln. 1-25).
Regarding claim 14, Leonard discloses the invention of claim 12, Leonard further discloses: wherein the insulting chamber is configured to receive a portion of the heat-exchange fluid from the heat exchanger as the insulating fluid (Ex. Fig. 1, insulating chamber (66) including insulating fluid inlet at end of heat-exchanger fluid inlet (28); col. 6 ln. 34-65 and col. 7 ln. 1-25).
Regarding claim 15, Leonard discloses the invention of claim 12, Leonard further discloses: wherein the insulating fluid is a fluid other than blood flowing through the oxygenator (Ex. Fig. 1, insulating chambers including insulating chamber (66) configured to receive heat-exchange fluid, insulating chamber (62) configured to receive gas; col. 6 ln. 34-65 and col. 7 ln. 1-25).
Regarding claim 16, Leonard discloses the invention of claim 12, Leonard further discloses: wherein ends of the heat-exchange fibers are embedded in a potting material (38b-c; col. 7 ln. 26-31).
Regarding claim 17, Leonard discloses the invention of claim 12, Leonard further discloses: wherein ends of the gas-exchange fibers are embedded in a potting material (38a and 38d; col. 7 ln. 26-31).
Regarding claim 18, Leonard discloses the invention of claim 17, Leonard further discloses: wherein at least a portion of the insulating chamber is disposed radially outward of the potting material upstream of the gas outlet end of the gas-exchange fibers (Ex. Fig. 1, third insulating fluid chamber configured to receive blood; col. 4 ln. 53-59).
Regarding claim 19, Leonard discloses the invention of claim 12, Leonard further discloses: wherein the heat-exchange fibers are woven into mats arranged in a criss-cross configuration (Fig. 3; col. 5 ln. 45-64).
Regarding claim 20, Leonard discloses the invention of claim 12, Leonard further discloses: wherein the gas-exchange fibers are woven into mats arranged in a criss-cross configuration (Fig. 3; col. 5 ln. 45-64).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Leonard as applied above.
Regarding claim 2, Leonard discloses the invention of claim 1; however, Leonard fails to explicitly disclose wherein the insulating fluid facilitates maintaining the gas-exchange fluid at a certain temperature or within a certain temperature range.
Regarding the limitation “wherein the insulating fluid facilitates maintaining the gas-exchange fluid at a certain temperature or within a certain temperature range” as that the invention of Leonard discloses substantially identical structure to the claimed prior art, the claimed results are considered to be inherent. As supported in MPEP 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).” In either of the insulating chamber (66) or the third insulating chamber, it would be considered that some kind of heat transfer may be occurring either from the heat-exchange fluid through the potting material (38a) or from the blood that has passed by the heat-exchange fibers (52) through the potting material (38b).
Regarding claim 13, Leonard discloses the invention of claim 12; however, Leonard fails to explicitly disclose wherein the insulating fluid facilitates maintaining the gas-exchange fluid at a certain temperature or within a certain temperature range.
Regarding the limitation “wherein the insulating fluid facilitates maintaining the gas-exchange fluid at a certain temperature or within a certain temperature range” as that the invention of Leonard discloses substantially identical structure to the claimed prior art, the claimed results are considered to be inherent. As supported in MPEP 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).” In either of the insulating chamber (66) or the third insulating chamber, it would be considered that some kind of heat transfer may be occurring either from the heat-exchange fluid through the potting material (38a) or from the blood that has passed by the heat-exchange fibers (52) through the potting material (38b).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Leonard as applied above, and further in view of U.S. Patent no. 4,948,560 A to Deguchi.
Regarding claim 11, Leonard discloses the invention of claim 1; however, Leonard differs from the instantly claimed invention in that Leonard fails to explicitly disclose a conduit disposed outside of the housing and configured to provide the insulating fluid to the insulating chamber.
Deguchi teaches an oxygenator comprising an insulating medium passed through a serpentine pipe embedded in the potting material of the gas-exchange fibers at the gas-exchanger outlet end (col. 3 ln. 52-68 and col. 4 ln. 1-10).
It would be considered obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the invention of Leonard to comprise a insulating fluid conduit configured to provide the insulating fluid to the insulating chamber as taught by Deguchi, because Deguchi teaches that this can provide direct insulation/heating to the potting material at the gas-exchange outlet end which is most susceptible to the phenomenon of wet lung (col. 3 ln. 52-68 and col. 4 ln. 1-10).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. JP/2012/135434 A to Muramoto discloses an oxygenator comprising a heat-exchanger, a gas-exchanger, and insulating chambers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
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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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/Linnae E. Raymond/Examiner, Art Unit 3781
/LESLIE R DEAK/Primary Examiner, Art Unit 3799 12 December 2025