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, Species A, Figures 1-6 in the reply filed on December 18, 2025 is acknowledged.
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 26-28 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.
Claim 25 recites the limitation ‘wherein the plurality of apertures extend along a longitudinal axis of the balloon, such that a plurality of longitudinally aligned apertures are in fluid communication with each inflation chamber’ in lines 1-3 of the claim. It is unclear whether the limitation ‘a plurality of longitudinally aligned apertures’ refers to the same apertures as ‘the plurality of apertures’ recited in line 1 of the claim or an additional set of longitudinally aligned apertures. The examiner interprets the limitation to be ‘wherein the plurality of apertures extend along a longitudinal axis of the balloon, such that the plurality of apertures are longitudinally aligned and in fluid communication with each inflation chamber’ to refer to the same apertures in line 1 for examination purposes.
Claim 26 recites the limitation “a plurality of inflation lumens in line 2 of the claim as well as in line 9 of the claim. It is unclear whether the limitation in line 9 refers to the same plurality of inflation lumens or a separate set for inflation lumens. The examiner interprets the limitation in line 9 to be the same plurality of inflation lumens as in line 2 for examination purposes.
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.
Claims 1, 2, 4, 5, 8, 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kelley et al (US 7887557).
Regarding claim 1, Kelley et al (hereafter Kelley) discloses a medical device, comprising: an outer shaft (30) having a distal end region; an inner shaft (28) extending within the outer shaft (30), the inner shaft (31) having an outer surface, a proximal end and a distal end; a balloon (16) including a distal waist (38) coupled to the distal end of the inner shaft, a proximal waist (36) coupled to the distal end of the outer shaft, an inner surface and a wall; a first interior partition panel (26) disposed within the balloon, wherein the first interior partition panel is coupled to both the outer surface of the inner shaft and the inner surface of the balloon (figure 2, C:2, L:62-67); and a second interior partition panel disposed within the balloon, wherein the second interior partition panel is coupled to both the outer surface of the inner shaft and the inner surface of the balloon (figure 2); wherein the first interior partition panel is circumferentially spaced away from the second interior partition panel (figure 4).
Regarding claim 2, Kelley discloses all of the limitations set forth in claim 1, wherein the balloon is configured to shift between an inflated configuration and a deflated configuration (figure 4-5), and wherein the balloon includes a first inflation chamber (24) positioned between the first interior panel and the second interior panel .
Regarding claim 4, Kelley discloses all of the limitations set forth in claim 1, wherein both of the first panel and the second panel (26) extend along a longitudinal axis of the inner shaft (figure 3).
Regarding claim 5, Kelley discloses all of the limitations set forth in claim 1, wherein the first panel is attached to the inner shaft along a first longitudinal attachment region, and wherein the first panel is substantially perpendicular to a tangent line passing through a point on the first attachment region along the inner shaft (figure 4).
Regarding claim 8, Kelley discloses all of the limitations set forth in claim 1, wherein the balloon is configured to shift between an inflated configuration and a deflated configuration, and wherein the portions of the balloon wall adjacent a portion of the balloon wall attached to the first panel and the second panel are configured to collapse onto the first panel and the second panel in the deflated configuration (figure 5).
Regarding claim 21, Kelley discloses all of the limitations set forth in claim 1, wherein the balloon further comprises a body portion positioned between a proximal cone portion and a distal cone portion (figure 3), and wherein the first and second interior partition panels extend along the body portion, the proximal cone portion, and the distal cone portion (figure 3).
Claims 1, 2, 10, 22, 23, 24, 26, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sogawa et al (US 5308323).
Regarding claim 1, Sogawa et al (hereafter Sogawa) discloses a medical device, comprising: an outer shaft (6) having a distal end region; an inner shaft (8) extending within the outer shaft (6), the inner shaft (8) having an outer surface, a proximal end and a distal end; a balloon (2) including an inner surface and a wall (Figure 2) a distal waist coupled to the distal end of the inner shaft, a proximal waist coupled to the distal end of the outer shaft (figure 1, the limitation ‘coupled’ is sufficiently broad to encompass all of the components of the device coupled together); a first interior partition panel (3) disposed within the balloon, wherein the first interior partition panel is coupled to both the outer surface of the inner shaft and the inner surface of the balloon (figure 2); and a second interior partition panel disposed within the balloon, wherein the second interior partition panel is coupled to both the outer surface of the inner shaft and the inner surface of the balloon (figure 2); wherein the first interior partition panel is circumferentially spaced away from the second interior partition panel (figure 2).
Regarding claim 2, Sogawa discloses all of the limitations set forth in claim 1, wherein the balloon is configured to shift between an inflated configuration and a deflated configuration (C:2, L:56-68), and wherein the balloon includes a first inflation chamber (4) positioned between the first interior panel and the second interior panel (figures 2-4).
Regarding 10, Sogawa discloses all of the limitations set forth in claim 2, wherein the balloon further comprises a third interior partition panel (figure 2), wherein the third interior partition panel is attached to the outer surface of the inner shaft and an inner surface of the balloon, wherein the third interior partition panel is circumferentially spaced from the second interior partition panel, and wherein the balloon includes a second inflation (4) chamber positioned between the third interior panel and the second interior panel, and wherein the first inflation chamber is configured to be inflated independent of the second inflation chamber (C:3, L:10-16).
Regarding claim 22, Sogawa discloses all of the limitations set forth in claim 1, wherein the outer shaft comprises a plurality of inflation lumens (5), and wherein each inflation lumen is in fluid communication with a respective inflation chamber defined between adjacent interior partition panels (C:3, L:10-16).
Regarding claim 23, Sogawa discloses all of the limitations set forth in claim 22, wherein the outer shaft further comprises one or more rib members extending longitudinally along the outer shaft, wherein the rib members define the plurality of inflation lumens (5).
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Regarding claim 24, Sogawa discloses all of the limitations set forth in claim 22, further comprising a plurality of apertures (9) extending through the outer shaft, wherein the plurality of apertures are in fluid communication with the plurality of inflation lumens and the respective inflation chambers (C:2, L:40-50).
Regarding claim 26, Sogawa discloses a medical device, comprising: a catheter shaft (1) defining a plurality of inflation lumens (5); a balloon (2) including a distal waist coupled to the catheter shaft, a proximal waist coupled to the catheter shaft (the limitation “coupled” is sufficiently broad to encompass all portions of the device are connected to one another), an inner surface and a wall; a plurality of interior partition panels (3) disposed within the balloon, wherein each of the interior partition panels extends radially between the catheter shaft and the inner surface of the balloon (figure 2); and a plurality of inflation chambers (4) defined between adjacent interior partition panels; wherein the catheter shaft comprises the plurality of inflation lumens (5), and wherein each inflation lumen is in fluid communication with a respective inflation chamber defined between adjacent interior partition panels (C:3, L:10-15; C:2, L:44-49).
Regarding claim 27, Sogawa discloses all of the limitations set forth in claim 26, further comprising a plurality of apertures (9) extending through the catheter shaft, wherein the plurality of apertures are in fluid communication with the plurality of inflation lumens and the respective inflation chambers (C:2, L:40-50).
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abele et al (US 5704913).
Regarding claim 1, Abele et al (hereafter Abele) discloses a medical device, comprising: an outer shaft (26a, 28) having a distal end region; an inner shaft (26b) extending within the outer shaft (26a, 28), the inner shaft (26b, figure 7) having an outer surface, a proximal end and a distal end; a balloon (18) including an inner surface and a wall (18) a distal waist (36) coupled to the distal end of the inner shaft, a proximal waist coupled to the distal end of the outer shaft (30, figure 1; all components are coupled together); a first interior partition panel (38) disposed within the balloon, wherein the first interior partition panel is coupled to both the outer surface of the inner shaft and the inner surface of the balloon (all of the components are coupled to one another to form the whole); and a second interior partition panel disposed within the balloon (38, 38a, 38b, 38c), wherein the second interior partition panel is coupled to both the outer surface of the inner shaft and the inner surface of the balloon (all of the components are coupled to one another to form the whole), figures 2, 8, 9); wherein the first interior partition panel is circumferentially spaced away from the second interior partition panel (figures 2, 8 , 9).
Regarding claim 3, Abele discloses all of the limitations set forth in claim 1, wherein the balloon is configured to be inflated to a first pressure, and wherein the balloon wall between the first panel and the second panel has a diameter at the first pressure and wherein a portion of the balloon wall attached to the first panel has a diameter at the first pressure, and wherein the diameter of the balloon wall between the first panel and the second panel is greater than the diameter of the portion of the balloon wall attached to the first panel at the first pressure (figures 8, 9, 10).
Claims 29-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by SARA et al (US 20190216522).
Regarding claim 29, SARA discloses a medical device, comprising: a catheter shaft (12) defining a plurality of inflation lumens (88); a balloon including a distal waist coupled to the catheter shaft, a proximal waist coupled to the catheter shaft, an inner surface and a wall (figure 3A-8; all components are coupled together); a plurality of interior partition panels (58) disposed within the balloon, wherein each of the interior partition panels extends radially between the catheter shaft and the inner surface of the balloon (figure 2 and 4-8); and a plurality of inflation chambers (20) defined between adjacent interior partition panels; wherein the catheter shaft comprises a plurality of apertures (60, 62, 98) arranged along a longitudinal axis of the catheter shaft (figure 3A), and wherein a first set of the plurality of apertures are in fluid communication with a first one of the inflation chambers and a second set of the plurality of apertures are in fluid communication with a second one of the inflation chambers (paragraphs 0029, 0037).
Regarding claim 30, SARA discloses all of the limitations set forth in claim 29, wherein each of the inflation chambers is configured to be inflated independent of the others (paragraph 0025, 0037).
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.
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.
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kelley et al (US 7887557), as applied to claim 1 above, and further in view of Gaudoin et al (US 20010037140).
Regarding claims 6-9, Kelley discloses all of the limitations set forth in claim 1, wherein the first panel and the second panel are attached to the inner shaft along a first and second longitudinal attachment region, respectively, (figure 2), wherein the wings can fold over the cutting members (C:5, L:35-46) and the panels facilitate re-folding (C:6, L:38-52). However, Kelley does not disclose the first panel and second panel each form an acute angle relative to a tangent line passing through a point on the first and second attachment regions, respectively, along the inner shaft. Gaudoin et al (hereafter Gaudoin) teaches a catheter balloon, wherein it was known in the art at the time of the invention to make the balloon form a plurality of wings in the deflated state inclined at an acute angle (abstract) from a line tangent to an inner tubular member extending within the interior of the balloon to allow a first wing to fold onto a second winged portion and significantly reduce the balloon profile (figure 8, paragraph 007). Therefore, since the wings of the device of Kelley are formed and collapsed around the first and second panels, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the first and second panel, of the device of Kelley, form an acute angle relative to a tangent line passing through a point on the first and second attachment region, respectively, along the inner shaft to allow for first wing to fold onto a second winged portion, as taught by Gaudoin, in order to significantly reduce the balloon profile, such that the second panel is subsequently configured to fold onto the first panel in the deflated configuration.
Claims 25 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Sogawa et al (US 5308323), as applied to claims 24 and 27 above, and further in view of SARA et al (US 20190216522).
Regarding claims 25 and 28, Sogawa discloses all of the limitations set forth in claims 24 and 27, wherein that the plurality apertures are in fluid communication with each inflation chamber (C:2, L:33-49), but does not specifically disclose the plurality of apertures extend along a longitudinal axis of the balloon, such that they are longitudinally aligned. SARA et al (hereafter SARA) teaches a medical device comprising an outer shaft (24, 52), inner shaft (70), and a balloon comprising multiple interior partition panels (58), wherein the outer shaft comprises a plurality of inflation lumens (88) in fluid communication with a respective inflation chamber defined between adjacent interior partition panels, and it was known in the art at the time of the invention to include a plurality of apertures (98, 62, 66, 60) extending along a longitudinal axis of the balloon through the outer shaft, such that the plurality of apertures are longitudinally aligned and in fluid communication with the plurality of inflation lumens for independent (figure 2, paragraph 0029) and precise inflation depending on the morphology of the treatment site to ensure contact between the balloon treatment element and a variety of target tissue configurations (paragraph 0037). Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to make the plurality of apertures extend along a longitudinal axis of the balloon such that they are longitudinally aligned, as an obvious inflation aperture configuration for balloons with multiple interior partition panels at the time of the invention as taught by SARA, in order to allow for independent inflation of the balloon chambers to ensure contact between the balloon treatment element and a variety of target tissue configurations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANH T DANG/Primary Examiner, Art Unit 3771