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 .
In light of the amendments filed 04/20/2026 in which claims 1 and 12 were amended, claims 4-5 and 14-15 were cancelled, and claims 21-22 were added, claims 1-3, 6-13, and 16-22 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 1-3, 6-13, and 16-22 receive priority to the prior-filed application, filed on 06/01/2017.
Response to Arguments
Objections to the Specification
The objections to the specification are withdrawn in view of the amendments to the specification filed 04/20/2026.
Rejections of the Claims under 35 U.S.C. 112(b)
The rejections of the claims under 35 U.S.C. 112(b) are withdrawn in view of the amendments to the claims filed 04/20/2026.
Rejections of the Claims under 35 U.S.C. 102/103
Applicant's arguments filed 04/20/2026 have been fully considered but they are not persuasive and/or wherein the claim amendments have necessitated new grounds of rejection.
Regarding amended claims 1 and 12, the applicant asserts that the prior art to Leonard fails to disclose the newly added limitations: a cap formed separately from and secured to the housing, the cap at least partially defining the insulating chamber.
In response to the applicant’s argument, the examiner respectfully notes that Leonard was not used in the previous Office Action filed 12/16/2025 to read on the newly added limitations. Applicant’s argument is persuasive; therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Takahashi.
The amendments to the claims have necessitated the new grounds of rejection.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites the limitation “the insulting chamber” in ln. 18. This should read “the insulating chamber”. Appropriate correction is required.
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 (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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6-8, 11-13, 16-18, and 21-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP/3597892 B2 to Takahashi.
Regarding claim 1, Takahashi discloses an oxygenator configured to oxygenate blood flowing therethrough (para. 0010-0034; Fig. 1-4, heat exchanger equipped artificial lung/oxygenator 1), the oxygenator comprising:
a housing (Fig. 1-4, housing 2/25) having a blood inlet (Fig. 1-4, blood inlet 23 [referred to as heat-exchanger fluid inlet]; para. 0016, external blood perfusion type of heat exchanger requires swapping blood inlet with heat-exchanger fluid inlet; para. 0031) and a blood outlet (Fig. 1-4, blood outlet 7), the blood inlet and the blood outlet in fluid communication with an interior of the housing (para. 0022-0023; para. 0027; para. 0033);
a heat exchanger disposed within the housing (Fig. 1-4, heat exchanger housing 25 comprising heat exchanger 20; internal blood perfusion type shown, examiner relies on not shown embodiment of external blood perfusion type), the heat exchanger including a heat-exchange fluid inlet (Fig. 1-4, heat-exchange fluid inlet 21 [referred to as blood inlet]; para. 0016, external blood perfusion type of heat exchanger requires swapping blood inlet with heat-exchanger fluid outlet; para. 0031), a heat-exchange fluid outlet (Fig. 1-4, heat-exchange fluid outlet 22 [referred to as blood outlet]; para. 0016, external blood perfusion type of heat exchanger requires swapping heat exchanger blood outlet with heat-exchanger fluid outlet; para. 0031, external blood perfusion type of heat exchanger requires connecting heat exchanger blood outlet to insulating fluid inlet 11), 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 (Fig. 1-4, heat-exchange fibers 26; para. 0016, external blood perfusion type of heat exchanger requires swapping heat exchanger blood outlet with heat-exchanger fluid outlet; para. 0031, external blood perfusion type of heat exchanger requires connecting heat exchanger blood outlet to insulating fluid inlet 11; para. 0032);
a gas exchanger disposed within the housing (Fig. 1-4, gas exchanger housing 2 comprising gas exchanger; para. 0011; para. 0018), the gas exchanger including a gas-exchange fluid inlet (Fig. 1-4, gas inlet 9), a gas-exchange fluid outlet (Fig. 1-4, gas outlet 10), 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 (Fig. 1-4, gas-exchange fibers 3; para. 0021);
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 (Fig. 1-4, heat transfer medium flow section/cap 13 defining an insulating chamber proximate gas outlet 10; para. 0024-0025; para. 0031, external blood perfusion type of heat exchanger requires connecting heat exchanger blood outlet to insulating fluid inlet 11);
a cap formed separately from and secured to the housing and at least partially defining the insulating chamber (Fig. 1-4, heat transfer medium flow section/cap 13 defining an insulating chamber; para. 0024-0025; para. 0031, external blood perfusion type of heat exchanger requires connecting heat exchanger blood outlet to insulating fluid inlet 11);
wherein the insulating chamber is configured to receive a portion of the heat-exchange fluid from the heat exchanger as the insulating fluid (para. 0024-0025; para. 0031, external blood perfusion type of heat exchanger requires connecting heat exchanger blood outlet to insulating fluid inlet 11).
Regarding claim 2, Takahashi discloses the invention of claim 1. Takahashi further discloses wherein the insulating fluid facilitates maintaining the gas-exchange fluid at a certain temperature or within a certain temperature range (Fig. 1-4, cap 13 defining an insulating chamber; para. 0024-0025).
Regarding claim 3, Takahashi discloses the invention of claim 1. Takahashi 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 (Fig. 1-4, oxygenator 1 comprising cap 13 defining an insulating chamber comprising insulating fluid inlet 11 and insulating fluid outlet 12; para. 0024-0025).
Regarding claim 6, Takahashi discloses the invention of claim 1. Takahashi further discloses wherein the ends of the heat-exchange fibers are embedded in a potting material (Fig. 1-4, potting material 27a/27b; para. 0011; para. 0021; para. 0032).
Regarding claim 7, Takahashi discloses the invention of claim 1. Takahashi further discloses: wherein ends of the gas-exchange fibers are embedded in a potting material (Fig. 1-4, potting material 4a/4b; para. 0011; para. 0021).
Regarding claim 8, Takahashi discloses the invention of claim 1. Takahashi 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 (Fig. 1-4, cap 13 defining an insulating chamber is radially larger than potting material 4b).
Regarding claim 11, Takahashi discloses the invention of claim 1. Takahashi further discloses: a conduit disposed outside of the housing and configured to provide the insulating fluid to the insulating chamber (Fig. 1-4, oxygenator 1 comprising cap 13 defining an insulating chamber comprising insulating fluid inlet 11 and insulating fluid outlet 12; para. 0024-0025; para. 0031, external blood perfusion type of heat exchanger requires connecting heat exchanger blood outlet to insulating fluid inlet 11 via connecting tube 41 disposed outside of housing 2/25).
Regarding claim 12, Takahashi discloses an oxygenator configured to oxygenate blood flowing therethrough (para. 0010-0034; Fig. 1-4, heat exchanger equipped artificial lung/oxygenator 1), the oxygenator comprising:
a housing (Fig. 1-4, housing 2/25) having a blood inlet (Fig. 1-4, blood inlet 23 [referred to as heat-exchanger fluid inlet]; para. 0016, external blood perfusion type of heat exchanger requires swapping blood inlet with heat-exchanger fluid inlet; para. 0031) and a blood outlet (Fig. 1-4, blood outlet 7), the blood inlet and the blood outlet in fluid communication with an interior of the housing (para. 0022-0023; para. 0027; para. 0033);
a heat exchanger disposed within the housing (Fig. 1-4, heat exchanger housing 25 comprising heat exchanger 20; internal blood perfusion type shown, examiner relies on not shown embodiment of external blood perfusion type), the heat exchanger including a heat-exchange fluid inlet (Fig. 1-4, heat-exchange fluid inlet 21 [referred to as blood inlet]; para. 0016, external blood perfusion type of heat exchanger requires swapping blood inlet with heat-exchanger fluid outlet; para. 0031), a heat-exchange fluid outlet (Fig. 1-4, heat-exchange fluid outlet 22 [referred to as blood outlet]; para. 0016, external blood perfusion type of heat exchanger requires swapping blood inlet with heat-exchanger fluid outlet; para. 0031), a heat-exchange fluid outlet (Fig. 1-4, heat-exchange fluid outlet 22; para. 0016, external blood perfusion type of heat exchanger requires swapping heat exchanger blood outlet with heat-exchanger fluid outlet; para. 0031, external blood perfusion type of heat exchanger requires connecting heat exchanger blood outlet to insulating fluid inlet 11), 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 (Fig. 1-4, heat-exchange fibers 26; para. 0016, external blood perfusion type of heat exchanger requires swapping heat exchanger blood outlet with heat-exchanger fluid outlet; para. 0031, external blood perfusion type of heat exchanger requires connecting heat exchanger blood outlet to insulating fluid inlet 11; para. 0032);
a gas exchanger disposed within the housing (Fig. 1-4, gas exchanger housing 2 comprising gas exchanger; para. 0011; para. 0018), the gas exchanger including a gas-exchange fluid inlet (Fig. 1-4, gas inlet 9), a gas-exchange fluid outlet (Fig. 1-4, gas outlet 10), 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 (Fig. 1-4, gas-exchange fibers 3; para. 0021);
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 (Fig. 1-4, heat transfer medium flow section/cap 13 defining an insulating chamber proximate gas outlet 10 and comprising insulating fluid inlet 11 and insulating fluid outlet 12; para. 0024-0025; para. 0031, external blood perfusion type of heat exchanger requires connecting heat exchanger blood outlet to insulating fluid inlet 11);
a cap formed separately from and secured to the housing, wherein an inner surface of the cap at least partially defines the insulating chamber (Fig. 1-4, heat transfer medium flow section/cap 13 defining an insulating chamber; para. 0024-0025; para. 0031, external blood perfusion type of heat exchanger requires connecting heat exchanger blood outlet to insulating fluid inlet 11);
wherein the insulating chamber is configured to receive a portion of the heat-exchange fluid from the heat exchanger as the insulating fluid (para. 0024-0025; para. 0031, external blood perfusion type of heat exchanger requires connecting heat exchanger blood outlet to insulating fluid inlet 11).
Regarding claim 13, Takahashi discloses the invention of claim 12. Takahashi further discloses: wherein the insulating fluid facilitates maintaining the gas-exchange fluid at a certain temperature or within a certain temperature range (Fig. 1-4, cap 13 defining an insulating chamber; para. 0024-0025).
Regarding claim 16, Takahashi discloses the invention of claim 12. Takahashi further discloses wherein the ends of the heat-exchange fibers are embedded in a potting material (Fig. 1-4, potting material 27a/27b; para. 0011; para. 0021; para. 0032).
Regarding claim 17, Takahashi discloses the invention of claim 12. Takahashi further discloses: wherein ends of the gas-exchange fibers are embedded in a potting material (Fig. 1-4, potting material 4a/4b; para. 0011; para. 0021).
Regarding claim 18, Takahashi discloses the invention of claim 17. Takahashi 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 (Fig. 1-4, cap 13 defining an insulating chamber is radially larger than potting material 4b).
Regarding claim 21, Takahashi discloses the invention of claim 1. Takahashi further discloses wherein the insulating chamber is spaced apart from the gas outlet end of the bundle of gas-exchange fibers (Fig. 1-4, cap 13 defining an insulating chamber spaced from gas outlet end at potting material 4b by at least gas outlet 10).
Regarding claim 22, Takahashi discloses the invention of claim 12. Takahashi further discloses wherein the insulating chamber is spaced apart from the gas outlet end of the bundle of gas-exchange fibers (Fig. 1-4, cap 13 defining an insulating chamber spaced from gas outlet end at potting material 4b by at least gas outlet 10).
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 9-10 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Takahashi as applied above, and further in view of U.S. Patent no. 6,113,782 A to Leonard.
Regarding claims 9-10 and 19-20, Takahashi discloses the inventions of claims 1 and 12, respectively.
Takahashi differs from the instantly claimed invention in that Takahashi fails to disclose
(Claims 9 and 19) wherein the heat-exchange fibers are woven into mats arranged in a criss-cross configuration; and
(Claims 10 and 20) wherein the gas-exchange fibers are woven into mats arranged in a criss-cross configuration.
Leonard teaches an oxygenator (Fig. 4; col. 3 ln. 54-67 and col. 4 ln. 1-13) comprising
(Claims 9 and 19) a heat exchanger wherein the heat-exchange fibers are woven into mats arranged in a criss-cross configuration (Fig. 3; Fig. 4, heat-exchange fibers 52; col. 5 ln. 45-64; col. 6 ln. 66-67 and col. 7 ln. 1-25);
(Claims 10 and 20) a gas exchanger wherein the gas-exchange fibers are woven into mats arranged in a criss-cross configuration (Fig. 3; Fig. 4, gas-exchange fibers 44; col. 5 ln. 45-64; col. 6 ln. 34-65); and
wherein weaving the fibers into mats allows for easy organization of the hollow fibers into a preferred arrangement or alignment (col. 2 ln. 63-67; col. 5 ln. 45-64).
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 heat-exchange and gas-exchange fibers of Takahashi to be woven into mats arranged in a criss-cross configuration as taught by Leonard, because Leonard teaches that this allows for easy organization of the hollow fibers into a preferred arrangement or alignment (col. 2 ln. 63-67; col. 5 ln. 45-64).
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 Linnae Raymond whose telephone number is (571)272-6894. The examiner can normally be reached M-F 8:00am to 4:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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