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
This Office Action is a response to applicant’s arguments and amendment filed 12/12/2025. Claims 1-2, 11 and 16-18 are amended. Claim 5 is cancelled. Claims 1-4 and 6-18 are currently pending.
The rejection of claims 1-18 under 35 U.S.C. 112(b) has been withdrawn due to applicant’s amendment.
Response to Arguments
Applicant’s arguments, see Remarks, filed 12/12/2025, with respect to the rejection(s) of claim(s) 1-18 under 35 U.S.C. 102(a)(1) as being anticipated by Meyer, have been fully considered but are not persuasive, in combination with the amendments to the claims. The rejection has been modified, necessitated by applicant’s amendments to the claims.
Applicant argues Meyer fails to disclose each of the plurality of first portions curves in a circular arc shape centered on the center axis, because each curved portion in Meyer appears to be centered on a different local center axis (Remarks, pgs. 8-9).
In response to applicant’s first argument, it is respectfully submitted Meyer describes wings 67 folded to provide a smooth circular outer surface as shown in fig. 5, which clearly depicts wings 67 centered on axis 39 and in a circular arc shape. Figure 4 also depicts wings 67 centered on center axis, which are then folded and still considered to be centered on the axis in fig. 5. Applicant appears to be arguing that the presence of elements 61 creates an off-center axis for each of wings 67, however, this does not preclude wings 67 from being folded surrounding axis 39. Each wing folds around axis 39 to form a smooth circular outer surface, such that each wing curves in a circular arc shape, and each of the shapes is centered on axis 39, since figs. 4-5 depict wings centered on the axis and folded to create a circular outer surface over elements 61. Note this also appears to be consistent with fig. 2a of the instant specification.
Applicant further argues Meyer does not teach or suggest the recited plurality of second portions, because the plurality of second portions do not have the claimed distance or rigidity (Remarks, pgs. 9-10).
In response to applicant’s second argument, it is respectfully submitted the arguments are narrower than the claim limitations. Applicant argues all the remaining regions outside of the plurality of first portions depicted in annotated fig. 4 (provided in the remarks) would constitute the plurality of second portions which do not have the claimed rigidity, however this is not claimed. The claim language recites a plurality of second portions adjacent to a plurality of first portions, which is not equivalent to the stated portions as provided in applicant’s remarks, and does not preclude elements 61 meeting the limitation of the plurality of second portions being adjacent to the plurality of first portions. Therefore, the plurality of first portions and plurality of second portions as disclosed in Meyer meet the claimed distance and the claimed rigidity as discussed below, such that the rejection is maintained.
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.
Claim(s) 1-4 and 6-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meyer (US 2003/0153870 A1) (previously of record).
Regarding claim 2, Meyer discloses (see abstract; paras. [0024]-[0045]; figs. 1-15) a balloon (figs. 6 and 12) for a catheter (fig. 1) capable of being in an inflated state and a deflated state in accordance with changes in internal pressure (para. [0024]), the balloon for a catheter comprising:
an inflatable portion (center portion of balloon 46, annotated fig. 6) configured to, in a process of changing shape from the deflated state to the inflated state, inflate by moving to the outside in a radial direction centered on a center axis (longitudinal axis) extending in a predetermined extending direction (inflates outward, see figs. 4 and 7), and to form a tube shape extending in the extending direction in the inflated state (fig. 6);
a distal end connecting portion (annotated fig. 6) being a portion extending from a distal end portion of the inflatable portion, the distal end portion being an end portion on one side of the inflatable portion in the extending direction, and, in the inflated state, a diameter of the distal end connecting portion at one end portion being larger than a diameter at an other end portion, the one end portion being an end portion connected to the inflatable portion, and the other end portion being an end portion on an opposite side to the one end portion (annotated fig. 6); and
a proximal end connecting portion (annotated fig. 6) being a portion extending from a proximal end portion of the inflatable portion, the proximal end portion being an end portion on an other side of the inflatable portion in the extending direction, and, in the inflated state, a diameter of the proximal end connecting portion at one end portion of the proximal end connecting portion being larger than a diameter of an other end portion of the proximal end connecting portion, the one end portion being an end portion connected to the inflatable portion, and the other end portion being an end portion on an opposite side to the one end portion (annotated fig. 6), wherein
at least the inflatable portion includes
a plurality of first portions (67, para. [0031]) forming wings in the deflated state (fig. 4), and
a plurality of second portions (76, considered to be the flexible elongate elements 61 in a different shape, paras. [0029] and [0036]) adjacent to the plurality of first portions in a circumferential direction centered on the center axis (fig. 4), in the inflated state, and
in the inflated state (considered to be any state of the balloon as the balloon is being inflated, therefore encompassing inflated states prior to the configuration depicted in fig. 11, paras. [0031]-[0032]),
each of the plurality of first portions curves in a circular arc shape centered on the center axis (folded counterclockwise or clockwise to provide a smooth circular outer surface, considered to be centered on axis 39 and maintain circular arc shape during stages of inflation, para. [0031]; fig. 5), and
a distance, in the radial direction, from the center axis to each of the plurality of second portions is shorter than a distance, in the radial direction, from the center axis to each of the plurality of first portions (considered to be shorter in an inflated state as balloon is being inflated from the configuration of fig. 4 to the configuration of fig. 11, such that elements 61 maintain a shorter distance relative to wings 67 as the balloon is inflated, paras. [0031]-[0032]), and
each of the plurality of second portions has a higher rigidity than that of the plurality of first portions (formed of rigid materials, considered to have a higher rigidity compared to portions of balloon, which Meyer is silent to describing as rigid, para. [0029]).
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Annotated Figure 6 of Meyer
Regarding claim 1, Meyer discloses the balloon for a catheter according to claim 2. Meyer further discloses wherein the plurality of second portions causes formation of indentations recessed toward the center axis, by moving toward the center axis in advance of the plurality of first portions, in the process of changing shape from the inflated state to the deflated state (indentations depicted in fig. 4, note elements 76 are considered to form indentations during use of the device when the balloon is inflated and deflated, paras. [0031]-[0033] and [0040]).
Regarding claim 3, Meyer discloses the balloon for a catheter according to claim 1. Meyer further discloses wherein the distal end connecting portion and the proximal end connecting portion each include the plurality of first portions and the plurality of second portions (figs. 4-6 and 12), and each of the plurality of first portions and the plurality of second portions extend from the other end portion of the distal end connecting portion to the other end portion of the proximal end connecting portion in the extending direction (extend along entirety of the balloon, paras. [0029] and [0036]; figs. 4-6 and 12).
Regarding claim 4, Meyer discloses the balloon for a catheter according to claim 1. Meyer further discloses wherein the distal end connecting portion and the proximal end connecting portion each include the plurality of first portions and the plurality of second portions (figs. 4-6 and 12), each of the plurality of first portions and plurality of second portions extend from the other end portion of the distal end connecting portion to the other end portion of the proximal end connecting portion in the extending direction (extend along entirety of the balloon, paras. [0029] and [0036]; figs. 4-6 and 12), and an amount of the indentations formed in the process of changing shape from the inflated state to the deflated state is larger at the inflatable portion than at the distal end connecting portion and the proximal end connecting portion (considered to be larger due to inflatable portion expanding to a larger diameter, figs. 6 and 12).
Regarding claim 6, Meyer discloses the balloon for a catheter according to claim 1. Meyer further discloses wherein a thickness, in the radial direction, of each of the plurality of second portions is larger than a thickness, in the radial direction, of each of the plurality of first portions (depicted in fig. 11).
Regarding claim 7, Meyer discloses the balloon for a catheter according to claim 6. Meyer further discloses wherein in the inflated state (considered to be any state of the balloon as the balloon is being inflated, therefore encompassing inflated states prior to the configuration depicted in fig. 11), a distance between an inner surface of the plurality of second portions and the center axis is shorter than a distance between an inner surface of the plurality of first portions and the center axis (considered to be shorter in an inflated state as balloon is being inflated from the configuration of fig. 4 to the configuration of fig. 11, such that elements 61 maintain a shorter distance relative to wings 67 as the balloon is inflated, paras. [0031]-[0032]).
Regarding claim 8, Meyer discloses the balloon for a catheter according to claim 6. Meyer further discloses wherein in the inflated state, a distance between an outer surface of the plurality of second portions and the center axis is longer than a distance between an outer surface of the plurality of first portions and the center axis (depicted in fig. 11 as balloon is inflated, first portions considered to be portions of balloon surrounding 76).
Regarding claim 10, Meyer discloses the balloon for a catheter according to claim 1. Meyer further discloses wherein the plurality of second portions is disposed at equal intervals in the circumferential direction (fig. 11).
Regarding claim 11, Meyer discloses the balloon for a catheter according to claim 1. Meyer further discloses wherein a shape in which the indentations recessed toward the center axis are formed by the plurality of second portions is remembered (may be formed of Nitinol, a known shape-memory material, para. [0029]).
Regarding claim 12, Meyer discloses the balloon for a catheter according to claim 1. Meyer further discloses wherein the plurality of first portions and the plurality of second portions are formed from the same material (balloon and flexible elongate elements may both be formed of Nylon, paras. [0028]-[0029]).
Regarding claim 13, Meyer discloses the balloon for a catheter according to claim 3. Meyer further discloses wherein of the plurality of second portions, at least one slit is provided at a portion disposed at the distal end connecting portion (cutouts 81 provided in elements 76, considered to be provided in elements 76 at distal end connecting portion, para. [0038]).
Regarding claim 14, Meyer discloses the balloon for a catheter according to claim 3. Meyer further discloses wherein of the plurality of second portions, at least one slit is provided at a portion disposed at the proximal end connecting portion (cutouts 81 provided in elements 76, considered to be provided in elements 76 at proximal end connecting portion, para. [0038]).
Regarding claim 15, Meyer discloses the balloon for a catheter according to claim 1. Meyer further discloses wherein of the plurality of second portions, at least one slit is provided at a portion disposed at the inflatable portion (cutouts 81 provided in elements 76, considered to be provided in elements 76 at inflatable portion, para. [0038]).
Regarding claim 16, Meyer discloses the balloon for a catheter according to claim 1. Meyer further discloses wherein each of the plurality of first portions includes: an apex having the greatest curvature in the process of changing shape from the inflated state to the deflated state (apex of 67, depicted in figs. 4-5), a first extending portion extending to the apex from a connecting portion with at least one of the plurality of second portions adjacent to one side of the respective one of the plurality of first portions in the circumferential direction, and a second extending portion extending to the apex from a connecting portion with at least one of the plurality of second portions adjacent to an other side of the respective one of the plurality of first portions in the circumferential direction (annotated fig. 5), and a length of the second extending portion is longer than a length of the first extending portion (depicted as longer in annotated fig. 5).
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Annotated Figure 5 of Meyer
Regarding claim 17, Meyer discloses the balloon for a catheter according to claim 1. Meyer further discloses wherein each of the plurality of first portions includes an apex having the greatest curvature in the process of changing shape from the inflated state to the deflated state (apex of 67, depicted in figs. 4-5), and in the process of changing shape from the inflated state to the deflated state, a distance between the apex and at least one of the plurality of second portions adjacent to an other side of a respective one of the plurality of first portions in the circumferential direction with respect to the apex of the respective one of the plurality of first portions is longer than a distance between the apex and at least another one of the plurality of second portions adjacent to one side of the respective one of the plurality of first portions in the circumferential direction (depicted as longer in annotated fig. 5, see distance of first extending portion relative to an element 61 and distance of second extending portion relative to an element 61).
Regarding claim 18, Meyer discloses the balloon for a catheter according to claim 1. Meyer further discloses wherein each of the plurality of first portions includes an apex having the greatest curvature in the process of changing shape from the inflated state to the deflated state (apex of 67, depicted in figs. 4-5), a first extending portion extending to the apex from a connecting portion with at least one of the plurality of second portions adjacent to one side of the respective one of the plurality of first portions in the circumferential direction, and a second extending portion extending to the apex from a connecting portion with at least one of the plurality of second portions adjacent to an other side of the respective one of the plurality of first portions in the circumferential direction (element 61 considered to be on an other side of second extending portion, annotated fig. 5), and in the process of changing shape from the inflated state to the deflated state, at least a portion of the first extending portion of at least one of the plurality of first portions including the apex is disposed on the other side of the at least one of the plurality of first portions in the circumferential direction with respect to a virtual plane extending in the radial direction and passing through the center axis and the apex (see dotted line extending through apex and center axis, and first extending portion extending on the side the second extending portion is extending on as defined by the claim).
Regarding claim 2, Meyer discloses (see abstract; paras. [0024]-[0045]; figs. 1-15), under an alternative interpretation with respect to the plurality of second portions, a balloon (figs. 6 and 12) for a catheter (fig. 1) capable of being in an inflated state and a deflated state in accordance with changes in internal pressure (para. [0024]), the balloon for a catheter comprising:
an inflatable portion (center portion of balloon 46, annotated fig. 6) configured to, in a process of changing shape from the deflated state to the inflated state, inflate by moving to the outside in a radial direction centered on a center axis (longitudinal axis) extending in a predetermined extending direction (inflates outward, see figs. 4 and 7), and to form a tube shape extending in the extending direction in the inflated state (fig. 6);
a distal end connecting portion (annotated fig. 6) being a portion extending from a distal end portion of the inflatable portion, the distal end portion being an end portion on one side of the inflatable portion in the extending direction, and, in the inflated state, a diameter of the distal end connecting portion at one end portion being larger than a diameter at an other end portion, the one end portion being an end portion connected to the inflatable portion, and the other end portion being an end portion on an opposite side to the one end portion (annotated fig. 6); and
a proximal end connecting portion (annotated fig. 6) being a portion extending from a proximal end portion of the inflatable portion, the proximal end portion being an end portion on an other side of the inflatable portion in the extending direction, and, in the inflated state, a diameter of the proximal end connecting portion at one end portion of the proximal end connecting portion being larger than a diameter of an other end portion of the proximal end connecting portion, the one end portion being an end portion connected to the inflatable portion, and the other end portion being an end portion on an opposite side to the one end portion (annotated fig. 6), wherein
at least the inflatable portion includes
a plurality of first portions (67, para. [0031]) forming wings in the deflated state (fig. 4), and
a plurality of second portions (flexible elongate elements 61, para. [0029]) adjacent to the plurality of first portions in a circumferential direction centered on the center axis (fig. 4), in the inflated state, and
in the inflated state (considered to be any state of the balloon as the balloon is being inflated, therefore encompassing inflated states prior to the configuration depicted in fig. 11, paras. [0031]-[0032]),
each of the plurality of first portions curves in a circular arc shape centered on the center axis (folded counterclockwise or clockwise to provide a smooth circular outer surface, considered to be centered on axis 39 and maintain circular arc shape during stages of inflation, para. [0031]; fig. 5), and
a distance, in the radial direction, from the center axis to each of the plurality of second portions is shorter than a distance, in the radial direction, from the center axis to each of the plurality of first portions (considered to be shorter in an inflated state as balloon is being inflated from the configuration of fig. 4 to the configuration of fig. 11, such that elements 61 maintain a shorter distance relative to wings 67 as the balloon is inflated, paras. [0031]-[0032]), and
each of the plurality of second portions has a higher rigidity than that of the plurality of first portions (formed of rigid materials, considered to have a higher rigidity compared to portions of balloon, which Meyer is silent to describing as rigid, para. [0029]).
Regarding claim 1, Meyer discloses the balloon for a catheter according to claim 2. Meyer further discloses wherein the plurality of second portions causes formation of indentations recessed toward the center axis, by moving toward the center axis in advance of the plurality of first portions, in the process of changing shape from the inflated state to the deflated state (indentations depicted in fig. 4, note elements 61 are considered to form indentations during use of the device when the balloon is inflated and deflated, paras. [0031]-[0033]).
Regarding claim 9, Meyer discloses the balloon for a catheter according to claim 1. Meyer further discloses wherein an outer surface of the plurality of second portions has a rounded shape (figs. 4 and 7).
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.
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/BRIGID K BYRD/Examiner, Art Unit 3771