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 .
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-12 in the reply filed on 12/08/2025 is acknowledged.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/08/2025.
Response to Amendment
The amendment filed 12/08/2025 has been entered. Claims 13-20 have been cancelled. Claims 21-27 are new. Claims 1-12, 21-27 remain pending in this application.
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.
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.
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.
Claim(s) 1-5, 7-12, 21, and 24-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mortensen et al. (Pub. No.: US 2004/0052681 A1).
Regarding claim 1, Mortensen discloses (fig. 1) an oxygenator (compliant blood gas exchanger 100, ¶ 0002), comprising:
A housing (104) extending from a first end (106) to a second end (108) along a central longitudinal axis (fig. 1, ¶ 0034);
A first end cap (126) fixedly attached to the first end of the housing (¶ 0039);
A second end cap (134) fixedly attached to the second end of the housing (¶ 0039); and
A bundle of hollow gas exchange fibers (hollow fiber assembly 102 including a plurality of hollow fibers 12) extending between the first end of the housing and the second end of the housing (¶ 0035-¶ 0036).
Mortensen fails to disclose wherein the first end cap and the second end cap are each rotatable about the central longitudinal axis.
However, such limitation relates to the function of the system. Mortensen discloses the housing having a sidewall (110) constructed of a flexible material (¶ 0047) with the first and second end caps being fixedly attached to the first and second ends of the housing, respectively. The oxygenator of Mortenson is therefore identical to the device as claimed. Thus, the first end cap and the second end cap of Mortensen are capable of being rotatable about the central longitudinal axis.
Features of an apparatus may be recited either structurally or functionally. In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997). See also MPEP § 2173.05(g). If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432.
Regarding claim 2, Mortensen discloses wherein the housing includes a flexible portion disposed between the first end and the second end (¶ 0047).
Regarding claim 3, Mortensen discloses wherein the housing extends continuously from the first end of the housing to the second end of the housing (fig. 1, ¶ 0034).
Regarding claim 4, Mortensen discloses (annotated fig. 1) wherein the bundle of hollow gas exchange fibers comprises:
A first bundle of hollow gas exchange fibers extending between the first end of the housing and a middle junction disposed between the first end and the second end of the housing (annotated fig. 1, first bundle comprising first and second segments 150, middle junction defined by third segment); and
A second bundle of hollow gas exchange fibers extending between the middle junction and the second end of the housing (annotated fig. 1, second bundling comprising fourth and fifth segments, middle junction defined by third segment).
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Mortensen annotated fig. 1
Mortensen fails to disclose wherein the first end cap is rotatable about the central longitudinal axis in a first direction and the second end cap is rotatable about the central longitudinal axis in a second direction opposite the first direction simultaneously with the first end cap.
However, such limitation relates to the function of the system. Mortensen discloses the housing having a sidewall (110) constructed of a flexible material (¶ 0047) with the first and second end caps being fixedly attached to the first and second ends of the housing, respectively. The oxygenator of Mortenson is therefore identical to the device as claimed. Thus, the first end cap and the second end cap of Mortensen are capable of being rotatable about the central longitudinal axis in a first and second direction, respectively and simultaneously.
Features of an apparatus may be recited either structurally or functionally. In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997). See also MPEP § 2173.05(g). If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432.
Regarding claim 5, Mortensen discloses wherein the first bundle of hollow gas exchange fibers and the second bundle of hollow gas exchange fibers are each fixedly attached to the middle junction (annotated fig. 1, bundles from the first end to the second end, ¶ 0035).
Regarding claim 7, Mortensen fails to disclose wherein the first end cap and the second end cap are configured to oscillate between the first direction and the second direction.
However, such limitation relates to the function of the system. Mortensen discloses the housing having a sidewall (110) constructed of a flexible material (¶ 0047) with the first and second end caps being fixedly attached to the first and second ends of the housing, respectively. The oxygenator of Mortenson is therefore identical to the device as claimed. Thus, the first end cap and the second end cap of Mortensen are capable of oscillating between the first direction and the second direction.
Features of an apparatus may be recited either structurally or functionally. In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997). See also MPEP § 2173.05(g). If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432.
Regarding claim 8, Mortensen discloses (annotated fig. 1) wherein the housing includes a first housing portion fixedly attached to the first end cap (see first segment, annotated fig. 1) and a second housing portion fixedly attached to the second end cap (see fifth segment, annotated fig. 1), wherein the first housing portion is axially spaced apart from the second housing portion (annotated fig. 1).
Regarding claim 9, Mortensen fails to disclose wherein the first housing portion is rotatable relative to the second housing portion.
However, such limitation relates to the function of the system. Mortensen discloses the housing having a sidewall (110) constructed of a flexible material (¶ 0047), wherein the housing includes a first housing portion fixedly attached to the first end cap and a second housing portion fixedly attached to the second end cap, wherein the first housing portion is axially spaced apart from the second housing portion. The oxygenator of Mortenson is therefore identical to the device as claimed. Thus, the first housing portion of Mortensen is capable of being rotatable relative to the second housing portion.
Features of an apparatus may be recited either structurally or functionally. In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997). See also MPEP § 2173.05(g). If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432.
Regarding claim 10, Mortensen discloses wherein the first housing portion is coupled to the second housing portion by a bridge section (see housing of the second, third and fourth segments, annotated fig. 1).
Regarding claim 11, Mortensen fails to disclose wherein the first housing portion is rotatable relative to the bridge section and the second housing portion is rotatable relative to the bridge section.
However, such limitation relates to the function of the system. Mortensen discloses the housing having a sidewall (110) constructed of a flexible material (¶ 0047), wherein the housing includes a first housing portion fixedly attached to the first end cap and a second housing portion fixedly attached to the second end cap, wherein the first housing portion is axially spaced apart from the second housing portion and wherein the first housing portion is coupled to the second housing portion by a bridge section. The oxygenator of Mortenson is therefore identical to the device as claimed. Thus, the first housing portion and second housing portion of Mortensen are capable of being rotatable relative to the bridge section.
Features of an apparatus may be recited either structurally or functionally. In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997). See also MPEP § 2173.05(g). If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432.
Regarding claim 12, Mortensen discloses wherein the first housing portion comprises a first bundle of hollow gas exchange fibers and the second housing portion comprises a second bundle of hollow gas exchange fibers (annotated fig. 1, ¶ 0041).
Regarding claim 21, Mortensen discloses (fig. 1) an oxygenator (compliant blood gas exchanger 100, ¶ 0002), comprising:
A housing (104) extending from a first end (106) to a second end (108) along a central longitudinal axis (fig. 1, ¶ 0034);
A first end cap (126) fixedly attached to the first end of the housing (¶ 0039);
A second end cap (134) fixedly attached to the second end of the housing (¶ 0039); and
A first bundle of hollow gas exchange fibers extending between the first end of the housing and a middle junction disposed between the first end and the second end of the housing (annotated fig. 1, hollow fiber assembly 102 having a first bundle comprising first and second segments 150, middle junction defined by third segment); and
A second bundle of hollow gas exchange fibers extending between the middle junction and the second end of the housing (annotated fig. 1, hollow fiber assembly 102 having a second bundling comprising fourth and fifth segments, middle junction defined by third segment).
Mortensen fails to disclose wherein the first end cap and the second end cap are each rotatable about the central longitudinal axis.
However, such limitation relates to the function of the system. Mortensen discloses the housing having a sidewall (110) constructed of a flexible material (¶ 0047) with the first and second end caps being fixedly attached to the first and second ends of the housing, respectively. The oxygenator of Mortenson is therefore identical to the device as claimed. Thus, the first end cap and the second end cap of Mortensen are capable of being rotatable about the central longitudinal axis.
Features of an apparatus may be recited either structurally or functionally. In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997). See also MPEP § 2173.05(g). If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432.
Regarding claim 24, Mortensen fails to disclose wherein the first end cap and the second end cap are configured to oscillate relative to the middle junction.
However, such limitation relates to the function of the system. Mortensen discloses the housing having a sidewall (110) constructed of a flexible material (¶ 0047) with the first and second end caps being fixedly attached to the first and second ends of the housing, respectively and a first bundle, a second bundle and middle junction therebetween. The oxygenator of Mortenson is therefore identical to the device as claimed. Thus, the first end cap and the second end cap of Mortensen are capable of oscillating relative to the middle junction.
Features of an apparatus may be recited either structurally or functionally. In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997). See also MPEP § 2173.05(g). If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432.
Regarding claim 25, Mortensen discloses (annotated fig. 1) wherein the housing includes a first housing portion fixedly attached to the first end cap (see first segment, annotated fig. 1) and a second housing portion fixedly attached to the second end cap (see fifth segment, annotated fig. 1), wherein the first housing portion is axially spaced apart from the second housing portion (annotated fig. 1).
Regarding claim 26, Mortensen fails to disclose wherein the first housing portion is rotatable relative to the second housing portion.
However, such limitation relates to the function of the system. Mortensen discloses the housing having a sidewall (110) constructed of a flexible material (¶ 0047), wherein the housing includes a first housing portion fixedly attached to the first end cap and a second housing portion fixedly attached to the second end cap, wherein the first housing portion is axially spaced apart from the second housing portion. The oxygenator of Mortenson is therefore identical to the device as claimed. Thus, the first housing portion of Mortensen is capable of being rotatable relative to the second housing portion.
Features of an apparatus may be recited either structurally or functionally. In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997). See also MPEP § 2173.05(g). If an examiner concludes that a functional limitation is an inherent characteristic of the prior art, then to establish a prima case of anticipation or obviousness, the examiner should explain that the prior art structure inherently possesses the functionally defined limitations of the claimed apparatus. In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432.
Regarding claim 27, Mortensen discloses wherein the first housing portion is coupled to the second housing portion by a bridge section (see housing of the second, third and fourth segments, annotated fig. 1).
Claim(s) 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mortensen, as applied to claim 21 above, and further in view of Autschbach et al. (Pub. No.: US 2005/0232811 A1).
Regarding claim 22, Mortensen fails to disclose wherein rotation of the first end cap about the central longitudinal axis moves the first end cap toward or away from the middle junction.
Autschbach teaches (fig. 1-3) an oxygenator (1) and thus in the same field of endeavor, comprising a first end cap (connection 12) and a second end cap (13), wherein rotation of the first end cap about a central longitudinal axis compresses the hollow gas exchange fibers (abstract, ¶ 0074), wherein the rotation and resulting compression increases gas exchange (¶ 0017).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first end cap of Mortensen such that rotation of the first end cap about the central longitudinal axis moves the first end cap toward or away from the middle junction, as suggested by Autschbach, in order to increase gas exchange (Autschbach ¶ 0017).
Regarding claim 23, Mortensen in view of Autschbach disclose wherein rotation of the second end cap about the central longitudinal axis moves the second end cap toward or away from the middle junction (Autschbach, abstract, ¶ 0074).
Allowable Subject Matter
Claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 6 recites “wherein rotation of the first end cap and the second end cap about the central longitudinal axis in opposite directions moves the first end cap closer to the second end cap.” The closest prior art is Autschbach et al. (Pub. No.: US 2005/0232811 A1) which discloses a first end cap and a second end cap (connections 12, 13), such end caps connected to the bundle of hollow gas exchange fibers, wherein relative rotation of the first end cap relative to the second end cap moves the first end cap closer to the second end cap (abstract, ¶ 0074). Autschbach fails to disclose, teach or suggest the feature of rotating the first and second end cap in opposite directions to move the first end cap closer to the second end cap, and rather only requires rotation of one end cap relative to the other end cap to move the first end cap closer to the second end cap.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Von Segesser (Pub. No.: US 2002/0143397 A1) discloses an oxygenator having a flexible housing. Hattler et al. (Pat. No.: 5,501,663) discloses an oxygenator having a flexible housing. Hamada et al. (Pat. No.: US 4,791,054) discloses an oxygenator having a first bundle and a second bundle of hollow gas exchange fibers. Hasegawa (Pat. No: US 4,376,095) discloses an oxygenator having a first bundle and a second bundle of hollow gas exchange fibers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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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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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781