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 .
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 4, 6-7, and 11-12 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.
The term “smallest” in claims 4, 6, and 11 is a relative term which renders the claim indefinite. The term “smallest” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this instance, the absolute smallest centrifugal force would be at the direct center of the device, which the cutout is clearly not at the direct center. It is not clear on if “the smallest” centrifugal force is relative to the anchor, relative to the entire device, etc., without a fully established reference. While [0054] recites the reference being the second anchor structure, the claim itself is still unclear since the claims do not necessarily require the same point of reference. For the purpose of examination, “where the centrifugal force is the smallest” will be interpreted as the cutouts being away from the distal ends, as the distal ends appear to be where centrifugal force would be the largest.
Similarly, the term “the largest” in claims 7 and 12 is a relative term which renders the claim indefinite. The term “the largest” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this instance, the limitation similarly does not establish a solid reference point for which the centrifugal point would be the largest. While [0054] recites the centrifugal force being largest when rotated about a specific axis, the claims do not necessarily require the same reference points. For the purpose of examination, the limitation will be interpreted the centrifugal force acting on the sealing material being near the ends of the oxygenator, as the distal ends appear to be where centrifugal force would be the largest.
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 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Hiraguchi (WO 2019151526, with citations pointing to US 20200345919 for the sake of convenience, both of which are based on PCT/JP2019/003958) in view of Totsuka (JP 2011056013).
Regarding claim 1, Hiraguchi discloses an oxygenator comprising:
a hollow fiber module (14a) having a plurality of hollow fiber membranes in a cylindrical arrangement (fig. 1 hollow fiber membrane 14a, paragraph 0062);
an outer tube (22) that is cylindrical and that accommodates the hollow fiber module with a gap between the outer tube and hollow fiber module (fig. 2, outer tube 22), wherein a sealing structure (82a) is provided at an end of the outer tube (22) which comprises an anchor structure (fig. 2, sealing member 82a provided at end of tube 22, see annotated fig. 2 below for anchor structure) having a groove (see annotated fig. 2 below) in the outer tube disposed along an inner peripheral side of the outer tube (see annotated fig. 2 below); and
a sealing material (82a) disposed in the gap and in the anchor structure, wherein the sealing material is introduced as a liquid in a flow into the groove and then cures in the groove (fig. 2, sealing member 82a within the anchor structure, paragraph 0088 describing the sealing member as a urethane resin which requires curing within the groove);
wherein the groove is recessed in an axial direction of the outer tube so that the sealing material and anchor structure are interlocking (annotated fig. 2 below shoes groove recessed in axial direction where material 82a and the annotated anchoring structure are interlocking).
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Hiraguchi does not teach wherein the groove further defines a cutout portion formed by cutting out the groove of the anchor structure on the inner peripheral side, and wherein the cutout portion is disposed at a region other than a region where the flow of sealing material is introduced.
However, Totsuka teaches wherein grooves further define a cutout portion on the inner peripheral side (fig. 7, area cut forming inclined surface 14 at an inner peripheral side), wherein the cutout portion is disposed at a region other than where the flow of sealing material is introduced (see translation, “the dialysate supply port 7 and the dialysate discharge port 8 also serve as injection ports for injecting the liquid sealing member 3 into the casing 2). Moreover, “formed by cutting out the groove of the anchor structure” is interpreted as a product-by-process claim, wherein the determination of patentability is based on the product itself. See MPEP 2113.
Therefore, 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 device disclosed in Hiraguchi by adding the inclined surface of Totsuka such that wherein the groove further defines a cutout portion formed by cutting out the groove of the anchor structure on the inner peripheral side, and wherein the cutout portion is disposed at a region other than a region where the flow of sealing material is introduced, as taught by Totsuka, for the purpose of providing a suitable structure that reduces bubbles within the sealing member during manufacturing (see Totsuka, abstract)
Regarding claim 2, Hiraguchi does not teach wherein the cutout portion includes a plurality of the cutouts provided at regions of the anchor structure facing each other in a circumferential direction
However, Totsuka teaches a plurality of the cutouts provided at regions of the anchor structure facing each other in a circumferential direction (fig. 6 shows the inclined surface 14, shown in fig. 7, as symmetrical)
Therefore, 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 device disclosed in Hiraguchi such that the cutout portion includes a plurality of the cutouts provided at regions of the anchor structure facing each other in a circumferential direction, as taught by Totsuka, for the purpose of providing a suitable structure that reduces bubbles within the sealing member during manufacturing (see Totsuka, abstract).
Regarding claim 3, Hiraguchi discloses wherein the groove of the anchor structure is formed having an outer inclined surface and an inner inclined surface meeting at ridge a with an acute angle (annotated fig. 2 below demonstrates the acute angle), but does not teach wherein the cutout portion is formed by cutting out a portion of the inner inclined surface at the inner peripheral side.
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However, Totsuka teaches wherein the cutout is on the inner peripheral side in a location corresponding to the inner inclined surface defined above (fig. 7, the incline 14 is on the inside of the casing 2). Moreover, “the cutout portion is formed by cutting out a portion” is interpreted as a product-by-process limitation, wherein the patentability is determined by what the product is and not its method of production. See MPEP 2113.
Therefore, 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 device disclosed in Hiraguchi such that the cutout portion is formed by cutting out a portion of the inner inclined surface at the inner peripheral side, as suggested by Totsuka, for the purpose of providing a suitable structure that reduces bubbles within the sealing member during manufacturing (see Totsuka, abstract).
Regarding claim 4, as best understood by the examiner, Hiraguchi does not teach wherein the outer tube and the hollow fiber module are rotated during the flow of the sealing material to apply a centrifugal force to the sealing material in the axial direction, wherein the cutout portion is provided at a position where the centrifugal force is applied away from the distal ends when the centrifugal force is applied in the axial direction of the outer tube.
However, Totsuka teaches wherein the outer tube and the hollow fiber module are rotated during the flow of the sealing material to apply a centrifugal force to the sealing material in the axial direction (fig. 6 demonstrates rotation around axis 19 which applies centrifugal force to the ends at the axial direction), wherein a cutout portion is provided at a position where the centrifugal force applied away from the distal ends when the centrifugal force is applied in the axial direction of the outer tube (fig. 6, as the device is rotating about axis 19, where the inclined surface 14 is further from the very distal ends of the device).
Moreover, “the outer tube and the hollow fiber module are rotated during the flow of the sealing material to apply a centrifugal force to the sealing material in the axial direction” is interpreted as a product-by-process limitation. While said limitation is utilized for the context of the location of the cutout portion, it is noted that determination of patentability is based on the product itself and does not depend on its method of production. See MPEP 2113.
Therefore, 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 device disclosed in Hiraguchi such that the outer tube and the hollow fiber module are rotated during the flow of the sealing material to apply a centrifugal force to the sealing material in the axial direction, wherein the cutout portion is provided at a position where the centrifugal force is away from the distal ends when the centrifugal force is applied in the axial direction of the outer tube, as taught by Totsuka, for the purpose of providing a suitable structure that reduces bubbles within the sealing member during manufacturing (see Totsuka, abstract).
Claims 5-14 are rejected under 35 U.S.C. 103 as being unpatentable over Hiraguchi in view of Totsuka, and further in view of Garvey (US 20180369470).
Regarding claim 5, Hiraguchi discloses a method for manufacturing an oxygenator (abstract) that includes a hollow fiber (14a) module having a plurality of hollow fiber membranes in a cylindrical arrangement (fig. 1 hollow fiber membrane 14a, paragraph 0062), an outer tube (22) that is cylindrical and that accommodates the hollow fiber module with a gap between the outer tube and the hollow fiber module (fig. 2, outer tube 22 defining a gap between the tube 22 and hollow fiber membrane 14a), and a sealing structure (82a) at an end of the outer tube which comprises an anchor structure fig. 2, sealing member 82a provided at end of tube 22, see annotated fig. 2 below for anchor structure) having a groove recessed in an axial direction of the outer tube (see annotated fig. 2 below), the method comprising the steps of:
accommodating the hollow fiber module into the outer tube (fig. 2, hollow fiber membrane 14a within the outer tube 22); and
filling the groove and the gap between the outer tube and the hollow fiber module with a sealing material introduced at an introduction region (paragraph 0072 describes the introduction region as between the end portion of the unit 14 and the first annular convex portion 42)
but does not teach wherein the groove defines a cutout portion formed by cutting out of the groove of the anchor structure on the inner peripheral side, wherein the method comprises filling the groove and gap while applying a centrifugal force in the axial direction of the outer tube so that the sealing material flows from the introduction region to the cutout portion.
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However, Totsuka teaches a groove that defines a cutout portion (14) formed on the groove of the anchor structure on the inner peripheral side (fig. 7, area cut forming inclined surface 14), and wherein the groove and gap is filled with sealing material at an introduction region while applying a centrifugal force in the axial direction of the outer tube so that the sealing material flows from the introduction region to the cutout portion (fig. 6 demonstrates a rotation of the casing 2 to spread the sealing member 3 toward the ends of casing 2 and introducing the sealing material into the cutout).
Therefore, 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 method disclosed in Hiraguchi by adding the inclined surface of Totsuka such that the cutout portion is formed on the groove of the anchor structure on the inner peripheral side, and wherein the groove and gap is filled with sealing material at an introduction region while applying a centrifugal force in the axial direction of the outer tube so that the sealing material flows from the introduction region to the cutout portion, as suggested by Totsuka, for the purpose of providing a suitable structure that reduces bubbles within the sealing member during manufacturing (see Totsuka, abstract).
Hiraguchi, as modified by Totsuka, is silent to wherein the cutout portion is formed by cutting out the groove of the anchor structure.
However, Garvey suggests that utilizing cuts to form aspects of the container for filters such as dialysis machines (abstract) is well known in the art (paragraph 0175).
Therefore, 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 method disclosed in Hiraguchi in view of Totsuka such that the cutout portion is formed by cutting out the groove, as suggested by Garvey, for the purpose of providing a suitable means known in the art for forming specific structures in oxygenators and dialysis filters.
Regarding claim 6, as best understood by the examiner, Hiraguchi discloses wherein, during the filling, the sealing material is introduced (paragraph 0072), but does not teach wherein the sealing material is introduced with the cutout portion being located at a region where the centrifugal force is away from the distal ends.
However, Totsuka teaches wherein a cutout portion is provided at a position where the centrifugal force is smallest when the centrifugal force is applied in the axial direction of the outer tube (fig. 6, as the device is rotating about axis 19, where the inclined surface 14 is further from the very distal ends of the device).
Therefore, 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 method disclosed in Hiraguchi such that the sealing material is introduced with the cutout portion being located at a region where the centrifugal force is the smallest, as taught by Totsuka, for the purpose of providing a suitable method that reduces bubbles within the sealing member during manufacturing (see Totsuka, abstract).
Regarding claim 7, as best understood by the examiner, Hiraguchi, as modified by Totsuka, discloses wherein, during the filling, the introduction region is located where the centrifugal force acting on the sealing material is towards the distal ends (fig. 2 and paragraph 0072 describe wherein the sealing member is added between the end portion and the first annular convex portion. This region would provide the centrifugal force of the sealing member applied towards the distal ends when rotated along the axis described in fig. 6 of Totsuka).
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 method disclosed in Hiraguchi such that during the filling, the introduction region is located where the centrifugal force acting on the sealing material is towards the distal ends, as suggested by Totsuka, for the purpose of providing a suitable method that reduces bubbles within the sealing member during manufacturing (see Totsuka, abstract).
Regarding claim 8, Hiraguchi does not teach wherein the cutout portion includes a plurality of the cutouts provided at regions of the anchor structure facing each other in a circumferential direction
However, Totsuka teaches a plurality of the cutouts provided at regions of the anchor structure facing each other in a circumferential direction (fig. 6 shows the inclined surface 14, shown in fig. 7, as symmetrical)
Therefore, 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 method disclosed in Hiraguchi such that the cutout portion includes a plurality of the cutouts provided at regions of the anchor structure facing each other in a circumferential direction, as taught by Totsuka, for the purpose of providing a suitable structure that reduces bubbles within the sealing member during manufacturing (see Totsuka, abstract).
Regarding claim 9, Hiraguchi discloses wherein the groove of the anchor structure is formed having an outer inclined surface and an inner inclined surface meeting at ridge a with an acute angle (annotated fig. 2 below demonstrates the acute angle), but does not teach wherein the cutout portion is formed by cutting out a portion of the inner inclined surface at the inner peripheral side.
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However, Totsuka teaches wherein the cutout is on the inner peripheral side in a location corresponding to the inner inclined surface defined above (fig. 7, the incline 14 is on the inside of the casing 2).
Moreover, as recited in claim 5 above, Garvey teaches wherein cutting structures for a filter used in instances such as for dialysis is a known method in the art (paragraph 0175).
Therefore, 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 method disclosed in Hiraguchi such that the cutout portion is formed by on a portion of the inner inclined surface at the inner peripheral side, as suggested by Totsuka, for the purpose of providing a suitable structure that reduces bubbles within the sealing member during manufacturing (see Totsuka, abstract).
Moreover, 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 method disclosed in Hiraguchi in view of Totsuka such that the cutout portion is formed by cutting out a portion of the inner inclined surface, as suggested by Garvey, Therefore, 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 method disclosed in Hiraguchi in view of Totsuka such that the cutout portion is formed by cutting out the groove, as suggested by Garvey, for the purpose of providing a suitable means known in the art for forming specific structures in oxygenators and dialysis filters.
Regarding claim 10, Hiraguchi discloses a method for manufacturing an oxygenator (abstract) comprising the steps of:
forming a hollow fiber module (14a) having a plurality of hollow fiber membranes in a cylindrical arrangement (fig. 1, hollow fiber membrane 14a, paragraph 0062);
forming an outer tube that is cylindrical (22), wherein the outer tube defines a sealing structure (82a) at an end of the outer tube which comprises an anchor structure having a groove recessed in an axial direction of the outer tube (see annotated fig. 2 below),
accommodating the hollow fiber module into the outer tube with a gap between the outer tube and hollow fiber module (2, hollow fiber membrane 14a within the outer tube 22 with a gap between the two); and
filling the groove and the gap between the outer tube and the hollow fiber module with a sealing material introduced at an introduction region (paragraph 0072 describes the introduction region as between the end portion of the unit 14 and the first annular convex portion 42)
but does not teach wherein the groove defines a cutout portion formed by cutting out of the groove of the anchor structure on the inner peripheral side, wherein the method comprises filling the groove and gap while applying a centrifugal force in the axial direction of the outer tube so that the sealing material flows from the introduction region to the cutout portion.
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However, Totsuka teaches a groove that defines a cutout portion (14) formed out of the groove of the anchor structure on the inner peripheral side (fig. 7, area cut forming inclined surface 14), and wherein the groove and gap is filled with sealing material at an introduction region while applying a centrifugal force in the axial direction of the outer tube so that the sealing material flows from the introduction region to the cutout portion (fig. 6 demonstrates a rotation of the casing 2 to spread the sealing member 3 toward the ends of casing 2 and introducing the sealing material into the cutout)
Therefore, 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 method disclosed in Hiraguchi by adding the inclined surface of Totsuka such that the groove defines a cutout portion formed by cutting out of the groove of the anchor structure on the inner peripheral side, wherein the method comprises filling the groove and gap while applying a centrifugal force in the axial direction of the outer tube so that the sealing material flows from the introduction region to the cutout portion, as taught by Totsuka, for the purpose of providing a suitable method that reduces bubbles within the sealing member during manufacturing (see Totsuka, abstract).
Hiraguchi, as modified by Totsuka, is silent to wherein the cutout portion is formed by cutting out the groove of the anchor structure.
However, Garvey suggests that utilizing cuts to form aspects of the container for filters such as dialysis machines (abstract) is well known in the art (paragraph 0175).
Therefore, 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 method disclosed in Hiraguchi in view of Totsuka such that the cutout portion is formed by cutting out the groove, as suggested by Garvey, for the purpose of providing a suitable means known in the art for forming specific structures in oxygenators and dialysis filters.
Regarding claim 11, as best understood by the examiner, Hiraguchi discloses wherein, during the filling, the sealing material is introduced (paragraph 0072), but does not teach wherein the sealing material is introduced with the cutout portion being located at a region where the centrifugal force is away from the distal ends.
However, Totsuka teaches wherein a cutout portion is provided at a position where the centrifugal force is smallest when the centrifugal force is applied in the axial direction of the outer tube (fig. 6, as the device is rotating about axis 19, where the inclined surface 14 is further from the very distal ends of the device).
Therefore, 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 method disclosed in Hiraguchi such that the sealing material is introduced with the cutout portion being located at a region where the centrifugal force is the smallest, as taught by Totsuka, for the purpose of providing a suitable method that reduces bubbles within the sealing member during manufacturing (see Totsuka, abstract).
Regarding claim 12, as best understood by the examiner, Hiraguchi, as modified by Totsuka, discloses wherein, during the filling, the introduction region is located where the centrifugal force acting on the sealing material is towards the distal ends (fig. 2 and paragraph 0072 describe wherein the sealing member is added between the end portion and the first annular convex portion. This region would provide the centrifugal force of the sealing member applied towards the distal ends when rotated along the axis described in fig. 6 of Totsuka).
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 method disclosed in Hiraguchi such that during the filling, the introduction region is located where the centrifugal force acting on the sealing material is towards the distal ends, as suggested by Totsuka, for the purpose of providing a suitable method that reduces bubbles within the sealing member during manufacturing (see Totsuka, abstract).
Regarding claim 13, Hiraguchi does not teach wherein the cutout portion includes a plurality of the cutouts provided at regions of the anchor structure facing each other in a circumferential direction
However, Totsuka teaches a plurality of the cutouts provided at regions of the anchor structure facing each other in a circumferential direction (fig. 6 shows the inclined surface 14, shown in fig. 7, as symmetrical)
Therefore, 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 method disclosed in Hiraguchi such that the cutout portion includes a plurality of the cutouts provided at regions of the anchor structure facing each other in a circumferential direction, as taught by Totsuka, for the purpose of providing a suitable structure that reduces bubbles within the sealing member during manufacturing (see Totsuka, abstract).
Regarding claim 9, Hiraguchi discloses wherein the groove of the anchor structure is formed having an outer inclined surface and an inner inclined surface meeting at ridge a with an acute angle (annotated fig. 2 below demonstrates the acute angle), but does not teach wherein the cutout portion is formed by cutting out a portion of the inner inclined surface at the inner peripheral side.
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However, Totsuka teaches wherein the cutout is on the inner peripheral side in a location corresponding to the inner inclined surface defined above (fig. 7, the incline 14 is on the inside of the casing 2).
Moreover, as recited in claim 5 above, Garvey teaches wherein cutting structures for a filter used in instances such as for dialysis is a known method in the art (paragraph 0175).
Therefore, 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 method disclosed in Hiraguchi such that the cutout portion is formed by on a portion of the inner inclined surface at the inner peripheral side, as suggested by Totsuka, for the purpose of providing a suitable structure that reduces bubbles within the sealing member during manufacturing (see Totsuka, abstract).
Moreover, 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 method disclosed in Hiraguchi in view of Totsuka such that the cutout portion is formed by cutting out a portion of the inner inclined surface, as suggested by Garvey, Therefore, 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 method disclosed in Hiraguchi in view of Totsuka such that the cutout portion is formed by cutting out the groove, as suggested by Garvey, for the purpose of providing a suitable means known in the art for forming specific structures in oxygenators and dialysis filters.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached M-F 7:30AM- 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at 5712705879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Brandon W. Levy/Examiner, Art Unit 3781