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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 17th, 2026 has been entered.
Response to Amendment
Claims filed on September 17th, 2026 have been entered. Claims 1-5, 7-8, 10- 14, and 16- 20 are pending in the application. Claims 19- 20 remain withdrawn for being drawn to an unelected invention.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-5, 7-8, 10-14, and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aggerholm et al. (US 2012/0191111) in view of Giasolli et al. (US 2022/0211983).
Regarding claim 1, Aggerholm (Aggerholm et al.) teaches a medical device (assembly 50)(Figs. 1 and 3-4), comprising:
a catheter shaft (52) having a distal region extending along a longitudinal axis (see annotated Fig. 4 below);
an inflatable balloon (balloon 200) secured to the distal region (see annotated Fig. 4 below); and
a monolithic blade member (one of scoring members 230) extending longitudinally relative to the inflatable balloon (see annotated Fig. 4 below), the monolithic blade member secured relative to an outer surface of the inflatable balloon (Paragraph 0043), the monolithic blade member comprising:
a base portion (small sliver 234 of rib member) extending from a first end of the monolithic blade member to a second end of the monolithic blade member (see annotated Fig. 3 below);
a blade portion extending outwardly from the base portion (see annotated Fig. 3 below), the blade portion including:
a first terminal blade segment extending from the first end of the monolithic blade member to a first flex point (gap 232)(Paragraphs 0036 and 0043) formed in the monolithic blade member, the first terminal blade segment having a first terminal blade segment length (see annotated Fig. 3 below);
a second terminal blade segment extending from the second end of the monolithic blade member to a second flex point (gap 232)(Paragraphs 0036 and 0043) formed in the monolithic blade member, the second terminal blade segment having a second terminal blade segment length (see annotated Fig. 3 below); and
at least one intermediate blade segment extending between the first flex point and the second flex point, each of the at least one intermediate blade segments having an intermediate blade segment length (see annotated Fig. 3 below).
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Regarding wherein the intermediate blade segment length is greater than the first terminal blade segment length and the second terminal blade segment length, it would be obvious to one of ordinary skill in the art that the intermediate blade segment length is greater than the first terminal blade segment length and the second terminal blade segment length since Aggerholm teaches that the scoring members of each monolithic blade member can be of different lengths (Paragraph 0030) and it appears in the embodiment in Fig. 3 that the intermediate blade segment length is greater than the first terminal blade segment length and the second terminal blade segment length (see annotated Fig. 3 below).
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Aggerholm does not teach wherein the first terminal blade segment length is less than 3 millimeters, wherein the second terminal blade segment length is less than 3 millimeters, or wherein the first flex point is adapted to enable the first terminal blade segment to be flexed at an angle greater than 30 degrees from the longitudinal axis, and the second flex point is adapted to enable the second terminal blade segment to be flexed at an angle greater than 30 degrees from the longitudinal axis.
However, since Aggerholm teaches that the device is within the same area of the body, that of the vasculature (Paragraphs 0006- 0016) and performs the same function as the device, that of scoring or cutting a lesion within a vessel (Paragraphs 0006- 0016 and 0022), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the length of the first terminal blade segment and the length of the second terminal blade segment to be less than 3 millimeters, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
Aggerholm does not teach wherein the first flex point is adapted to enable the first terminal blade segment to be flexed radially outward away from the longitudinal axis at an angle greater than 30 degrees from the longitudinal axis, and the second flex point is adapted to enable the second terminal blade segment to be flexed radially outward away from the longitudinal axis at an angle greater than 30 degrees from the longitudinal axis.
Giasolli teaches a similar device (catheter 3310, balloon 3316, cutting members 3320)(Figs. 32 and 33), comprising: a catheter (3310), a balloon (3316), a blade member (cutting members 3320) comprising a first terminal blade segment (first section 3344a) extending from a first end of the blade member to a flex point (gap or break 3346), and a second terminal blade segment (3344b) extending from the flex point to a second end of the blade member (see annotated Fig. 33 below), wherein the flex point is adapted to enable the first terminal blade segment to be flexed radially outward from the longitudinal axis at an angle of 20 degrees or more from a longitudinal axis (Giasolli teaches in Paragraph 0239 that the serrated segments of the cutting member, which the flex point is a part of, allows for the cutting member to flex laterally at an angle of 20 degrees or more, therefore it is able to be flexed at an angle greater than 30 degrees.).
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It would have been obvious to one of ordinary skill in the art to modify the first flex point and the second flex point as taught by Aggerholm to be adapted to enable the first terminal blade segment and the second terminal blade segment to be flexed radially outward away from the longitudinal axis at an angle greater than 20 degrees as taught by Giasolli, since Giasolli teaches that this allows for a “more flexible, more stable design” (Paragraph 0239).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the range as taught by the combination to be 30 or more degrees, since it has been held that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a primae facie case of obviousness exists”. (MPEP 2144.05)(In re Wertheim, 541 F.2d 257, 191 USPQ90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Alternatively, regarding wherein the first flex point is adapted to enable the first terminal blade segment to be flexed radially outward away from the longitudinal axis at an angle greater than 30 degrees from the longitudinal axis, and the second flex point is adapted to enable the second terminal blade segment to be flexed radially outward away from the longitudinal axis at an angle greater than 30 degrees from the longitudinal axis, it is noted that this language is functional, as the first flex point and the second flex point solely need to be adapted to enable the device to flex, therefore as the combination teaches the flex points (Aggerholm, Paragraphs 0036 and 0043) and that flexion occurs (Giasolli, Paragraph 0239), the combination a device capable of achieving these limitations.
Regarding claim 2, Aggerholm and Giasolli make obvious the device as discussed above.
Regarding wherein the first terminal blade segment length allows the first flex point to be within two millimeters of a first end of a lesion when the second flex point is within two millimeters of an opposing second end of the lesion, as this language is functional, the structure of the device only needs to be able to accomplish the function, therefore as Aggerholm teaches in Paragraphs 0042- 0044 that the flex point allows for the device to flex within the body, it would be capable of having the first flex point be within two millimeters of a first end of a lesion when the second flex point is within two millimeters of an opposing second end of the lesion.
Regarding claims 3 and 4, Aggerholm and Giasolli make obvious the device as discussed above.
Aggerholm further teaches wherein the first flex point comprises a first gap in the blade portion and wherein the second flex point comprises a second gap in the blade point, with the base portion extending without any gap (see annotated Fig. 3 below).
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Regarding claim 5, Aggerholm and Giasolli make obvious the device as discussed above.
Aggerholm is silent to wherein the first terminal blade segment length is equal to the second blade segment length with the base portion extending without any gap.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the first terminal blade segment length and the second blade segment length to be equal lengths, since it appears that Aggerholm shows the first and second blade segments lengths are about equal (see annotated Fig. 3 below).
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Regarding claim 7, Aggerholm and Giasolli make obvious the device as discussed above.
Aggerholm is silent to wherein the first terminal blade segment has a length of less than 2 millimeters.
However, since Aggerholm teaches that the device is within the same area of the body, that of the vasculature (Paragraphs 0006- 0016) and performs the same function as the device, that of scoring or cutting a lesion within a vessel (Paragraphs 0006- 0016 and 0022), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the length of the first terminal blade segment to be less than 2 millimeters, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
Regarding claim 8, Aggerholm and Giasolli make obvious the device as discussed above.
Aggerholm is silent to wherein the second terminal blade segment has a length of less than 2 millimeters.
However, since Aggerholm teaches that the device is within the same area of the body, that of the vasculature (Paragraphs 0006- 0016) and performs the same function as the device, that of scoring or cutting a lesion within a vessel (Paragraphs 0006- 0016 and 0022), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the length of the second terminal blade segment to be less than 2 millimeters, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
Regarding claim 10, Aggerholm and Giasolli make obvious the device as discussed above.
Aggerholm further teaches the device further comprising one or more additional monolithic blade members (sets 24- 28)(Paragraphs 0020 and 0027) extending longitudinally along the outer surface of the inflatable balloon (see annotated Fig. 4 below), each of the one or more additional monolithic blade members comprising:
a base portion (small sliver 234 of rib member) extending from a first end of the monolithic blade member to a second end of the monolithic blade member (see annotated Fig. 3 below);
a blade portion extending outwardly from the base portion (see annotated Fig. 3 below), the blade portion including:
a first terminal blade segment extending from the first end of the monolithic blade member to a first flex point (gap 232)(Paragraphs 0036 and 0043) formed in the monolithic blade member, the first terminal blade segment having a first terminal blade segment length (see annotated Fig. 3 below);
a second terminal blade segment extending from the second end of the monolithic blade member to a second flex point (gap 232)(Paragraphs 0036 and 0043) formed in the monolithic blade member, the second terminal blade segment having a second terminal blade segment length (see annotated Fig. 3 below); and
at least one intermediate blade segment extending between the first flex point and the second flex point, each of the at least one intermediate blade segments having an intermediate blade segment length (see annotated Fig. 3 below).
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Regarding wherein the intermediate blade segment length is greater than the first terminal blade segment length and the second terminal blade segment length, it would be obvious to one of ordinary skill in the art that the intermediate blade segment length is greater than the first terminal blade segment length and the second terminal blade segment length since Aggerholm teaches that the scoring members of each monolithic blade member can be of different lengths (Paragraph 0030) and it appears in the embodiment in Fig. 3 that the intermediate blade segment length is greater than the first terminal blade segment length and the second terminal blade segment length (see annotated Fig. 3 below).
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Regarding claim 11, Aggerholm (Aggerholm et al.) teaches a medical device (assembly 50)(Figs. 1 and 3-4), comprising:
an inflatable balloon (balloon 200) secured to a distal region of a catheter shaft (52) having a longitudinal axis (see annotated Fig. 4 below); and
a plurality of monolithic blade members (sets 24- 28 of blade members 230)(Paragraph 0020 and 0027) secured to the inflatable balloon (Paragraph 0043) and extending longitudinally with respect to the inflatable balloon (see annotated Fig. 4 below), each of the plurality of monolithic blade members comprising:
a base portion (small sliver 234 of rib member) extending from a first end of the monolithic blade member to a second end of the monolithic blade member (see annotated Fig. 3 below);
a blade portion extending outwardly from the base portion (see annotated Fig. 3 below), the blade portion including:
a first terminal blade segment extending from the first end of the monolithic blade member to a first flex point (gap 232)(Paragraphs 0036 and 0043) formed in the monolithic blade member, the first terminal blade segment having a first terminal blade segment length (see annotated Fig. 3 below);
a second terminal blade segment extending from the second end of the monolithic blade member to a second flex point (gap 232)(Paragraphs 0036 and 0043) formed in the monolithic blade member, the second terminal blade segment having a second terminal blade segment length (see annotated Fig. 3 below); and
at least one intermediate blade segment extending between the first flex point and the second flex point, each of the at least one intermediate blade segments having an intermediate blade segment length (see annotated Fig. 3 below).
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Aggerholm is silent to wherein the first terminal blade segment has a length of less than 3 millimeters, wherein the second terminal blade segment has a length of less than 3 millimeters, or wherein the intermediate blade segment length has a length of greater than 3 millimeters.
However, since Aggerholm teaches that the device is within the same area of the body, that of the vasculature (Paragraphs 0006- 0016) and performs the same function as the device, that of scoring or cutting a lesion within a vessel (Paragraphs 0006- 0016 and 0022), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the length of first terminal blade segment to be less than 3 millimeters and the second terminal blade segment to be less than 3 millimeters, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
Regarding the intermediate blade segment length having a length greater than 3 millimeters, since Aggerholm teaches that the scoring members of each monolithic blade member can be of different lengths (Paragraph 0030) and that the device is within the same area of the body, that of the vasculature (Paragraphs 0006- 0016) and performs the same function as the device, that of scoring or cutting a lesion within a vessel (Paragraphs 0006- 0016 and 0022), it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the length of the intermediate terminal blade segment to be greater than 3 millimeters and therefore greater than the first and second blade member lengths, as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimension would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04(IV)(A)).
Aggerholm does not teach wherein the first flex point is adapted to enable the first terminal blade segment to be flexed radially outward away from the longitudinal axis at an angle greater than 30 degrees from the longitudinal axis, and the second flex point is adapted to enable the second terminal blade segment to be flexed radially outward away from the longitudinal axis at an angle greater than 30 degrees from the longitudinal axis.
Giasolli teaches a similar device (catheter 3310, balloon 3316, cutting members 3320)(Figs. 32 and 33), comprising: a catheter (3310), a balloon (3316), a blade member (cutting members 3320) comprising a first terminal blade segment (first section 3344a) extending from a first end of the blade member to a flex point (gap or break 3346), and a second terminal blade segment (3344b) extending from the flex point to a second end of the blade member (see annotated Fig. 33 below), wherein the flex point is adapted to enable the first terminal blade segment to be flexed radially outward from the longitudinal axis at an angle of 20 degrees or more from a longitudinal axis (Giasolli teaches in Paragraph 0239 that the serrated segments of the cutting member, which the flex point is a part of, allows for the cutting member to flex laterally at an angle of 20 degrees or more, therefore it is able to be flexed at an angle greater than 30 degrees.).
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It would have been obvious to one of ordinary skill in the art to modify the first flex point and the second flex point as taught by Aggerholm to be adapted to enable the first terminal blade segment and the second terminal blade segment to be flexed radially outward away from the longitudinal axis at an angle greater than 20 degrees as taught by Giasolli, since Giasolli teaches that this allows for a “more flexible, more stable design” (Paragraph 0239).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the range as taught by the combination to be 30 or more degrees, since it has been held that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a primae facie case of obviousness exists”. (MPEP 2144.05)(In re Wertheim, 541 F.2d 257, 191 USPQ90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
Alternatively, regarding wherein the first flex point is adapted to enable the first terminal blade segment to be flexed radially outward away from the longitudinal axis at an angle greater than 30 degrees from the longitudinal axis, and the second flex point is adapted to enable the second terminal blade segment to be flexed radially outward away from the longitudinal axis at an angle greater than 30 degrees from the longitudinal axis, it is noted that this language is functional, as the first flex point and the second flex point solely need to be adapted to enable the device to flex, therefore as the combination teaches the flex points (Aggerholm, Paragraphs 0036 and 0043) and that flexion occurs (Giasolli, Paragraph 0239), the combination a device capable of achieving these limitations.
Regarding claim 12, Aggerholm and Giasolli make obvious the device as discussed above.
Aggerholm further teaches wherein the plurality of monolithic blade members comprise four blade members (scoring members 230 of sets 24- 28), each arranged circumferentially spaced about 90 degrees from a closest neighboring monolithic blade member (Paragraphs 0018, 0020, and 0027).
Regarding claims 13 and 14, Aggerholm and Giasolli make obvious the device as discussed above.
Aggerholm further teaches wherein for each of the plurality of monolithic blade members, the first flex point comprises a first gap (232) in the blade portion and wherein for each of the plurality of monolithic blade members, the second pivot point comprises a second gap (232) in the blade portion, with the base portion extending without any gap (Paragraphs 0018, 0020, and 0027)(see annotated Fig. 3 below).
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Regarding claim 16, Aggerholm and Giasolli make obvious the device as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the first flex point and the second flex point as taught by Aggerholm to be adapted to enable the first terminal blade segment and the second terminal blade segment to be flexed at an angle greater than 20 degrees as taught by Giasolli, since Giasolli teaches that this allows for a “more flexible, more stable design” (Paragraph 0239).
The combination further teaches wherein the first flex point is adapted to enable the first terminal blade segment to be flexed at an angle greater than 45 degrees from the longitudinal axis (As Giasolli teaches that the angle of flexion can be greater than 20 degrees (Paragraph 0239), and 45 degrees is greater than 20 degrees, Giasolli teaches this limitation.)
Regarding claim 17, Aggerholm and Giasolli make obvious the device as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the first flex point and the second flex point as taught by Aggerholm to be adapted to enable the first terminal blade segment and the second terminal blade segment to be flexed at an angle greater than 20 degrees as taught by Giasolli, since Giasolli teaches that this allows for a “more flexible, more stable design” (Paragraph 0239).
The combination further teaches wherein the second flex point is adapted to enable the second terminal blade segment to be flexed at an angle greater than 45 degrees from the longitudinal axis (As Giasolli teaches that the angle of flexion can be greater than 20 degrees (Paragraph 0239), and 45 degrees is greater than 20 degrees, Giasolli teaches this limitation.)
Regarding claim 18, Aggerholm and Giasolli make obvious the device as discussed above.
As discussed above, it would have been obvious to one of ordinary skill in the art to modify the first flex point and the second flex point as taught by Aggerholm to be adapted to enable the first terminal blade segment and the second terminal blade segment to be flexed at an angle greater than 20 degrees as taught by Giasolli, since Giasolli teaches that this allows for a “more flexible, more stable design” (Paragraph 0239).
Aggerholm teaches wherein the at least one intermediate blade segment extends parallel to the longitudinal axis (see annotated Fig. 4 below)(As Aggerholm teaches that the first terminal blade segment and the second terminal blade segment can extend to the cones of the balloon of Aggerholm (Paragraph 0028), when the intermediate blade segment is disposed on the longitudinal portion of the balloon, it would extend parallel to the longitudinal axis while the first and second terminal blade segments are flexed.).
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Response to Arguments
Applicant's arguments filed September 17th, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments, see Pages 8-10, regarding that Giasolli does not teach wherein the first flex point is adapted to enable the first terminal blade segment to be flexed radially outward away from the longitudinal axis at an angle greater than 30 degrees from the longitudinal axis and the second flex point is adapted to enable the second terminal blade segment to be flexed radially outward away from the longitudinal axis at an angle greater than 30 degrees from the longitudinal axis, these arguments have been fully considered but are not persuasive.
Regarding the claim limitations wherein the flex points are adapted to enable the first and second terminal blade segments to be flexed radially outward away from the longitudinal axis at an angle greater than 30 degrees from the longitudinal axis, the Examiner notes that the limitation, in the broadest reasonable interpretation, does not require a specific direction in relation to the longitudinal axis and can be interpreted as the blade segments being flexed from being bent flat against the surface of the balloon to standing or being flexed up relative to the longitudinal axis (see annotated Fig. 1 of Applicant’s specification). Examiner notes that the claim language does not specify how the blade segments are flexed radially outward and therefore can be either interpretation.
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Regarding applicant’s argument that Giasolli does not teach the claimed angular capability, this argument has been fully considered but is not persuasive. As Giasolli teaches a device with a gap and that the gap is the flexibility point (Paragraphs 0144, 0154, and 0169), defines the sides of a blade segment that lie parallel with the longitudinal axis as the lateral sides (sides 214, 216)(Paragraph 0154), and teaches that the cutting member, which has the gaps between the blade segments, provides lateral flexion (Paragraph 0239), one of ordinary skill in the art would be capable of determining that the angle Giasolli teaches within Paragraph 0236 regarding lateral flexion, would be flexion in regards to the longitudinal axis and that the flex point allows for the blade segment to be flexed radially outward away from the longitudinal axis at an angle greater than 30 degrees. Furthermore, as discussed above, since the limitation as set forth by applicant is broad and does not specify the direction required for the radially outward flexion, then Giasolli encompasses the claim limitation through teaching lateral flexion of cutting element. It is noted as well that it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the range as taught by the combination to be 30 or more degrees, since it has been held that “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a primae facie case of obviousness exists”. (MPEP 2144.05)(In re Wertheim, 541 F.2d 257, 191 USPQ90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
It is further noted, as discussed above to wherein the first flex point is adapted to enable the first terminal blade segment to be flexed radially outward away from the longitudinal axis at an angle greater than 30 degrees from the longitudinal axis, and the second flex point is adapted to enable the second terminal blade segment to be flexed radially outward away from the longitudinal axis at an angle greater than 30 degrees from the longitudinal axis, that this language is functional, as the first flex point and the second flex point solely need to be adapted to enable the device to flex, therefore as the combination teaches the flex points (Aggerholm, Paragraphs 0036 and 0043) and that flexion occurs (Giasolli, Paragraph 0239), the combination a device capable of achieving these limitations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272- 4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
