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 Arguments
The amendments/ arguments, dated 5/13/2026, have overcome:
The rejection of claim(s) 9, 12-15 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph;
The rejection of claim(s) 1-3, 17-19 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) based on Holman et al. (US 2008/0114331 A1 - as previously cited);
The aforementioned objections/ rejections have been withdrawn.
Applicant's arguments, with respect to the rejection of claim(s) 11-16 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) based on Holman et al. (US 2008/0114331 A1 – as previously cited), filed 5/13/2026, have been fully considered but they are not persuasive. Applicant argues: Holman et al. does not disclose a lubricious exterior surface of the inflatable body in both a portion that contacts the inner surface of the implant and a portion that is in between folds of the inflatable body when the inflatable body it deflated. Instead, Holman et al. discloses the benefits of a lubricant on only portions of the inflated balloon (specifically that the stability of the inflated balloon 105 within the blood vessel can be increased as compared to a fully coated balloon). As such, Holman et al. teaches away from a lubricant on both areas of the ballon, as currently claimed by Applicant. Examiner disagrees with this argument in part. Examiner agrees that Holman et al. discloses an inflated balloon which is not entirely coated with a lubricant (as argued above). However, balloon maybe be partially coated with lubricant and folded in a manner such that the partially coated portion can be both between folds of the inflatable balloon and in a portion that contacts an inner surface of the implant, as can be been in figs. 8 and 11E (and as further discussed below).
Applicant's arguments, with respect to the rejection of claim(s) 1-10, 17-20 under 35 U.S.C. 103 as being unpatentable over Stupecky et al. (US 2016/0008589 A1 - as previously cited), filed 5/13/2026, have been fully considered but they are not persuasive. Applicant argues: specifically with reference to the Examiners statement that it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the outer inflatable body fold radius to curvature (bend radius 10) since this is a result effective variable that Stupecky et al. teaches away from producing a larger radius of curvature (greater than or equal to the one half the thickness of the inflatable body) as Stupecky et al. discloses the advantages of having as reduced/ small as possible outer fold inflatable body fold radius of curvature. Examiner agrees in part. Although Examiner agrees Stupecky et al. is focused on reducing the bend radius 10. The fold radius of curvature as claimed does not have a defined location within the inflatable body when deflated. As such, Examiner is reinterpreting Stupecky et al. with the fold radius of curvature in an alternative location to meet the claim requirement, as detailed below.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 11-16 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Holman et al. (US 2008/0114331 A1 – as previously cited).
With respect to claim 11:
Holman et al. discloses a dilation device (balloon catheter 100), as can be seen in figs. 1-4, for an implant (stent 147) (paragraph [0054]), the dilation device (balloon catheter 100) comprising:
An inflatable body (balloon 105) having a proximal end (proximal waist portion 140) and a distal end (distal waist portion 145) (paragraph [0054]), and a central body (body portion 125) positioned between the proximal end (proximal waist portion 140) and the distal end (distal waist portion 145) and having a length (paragraph [0054]), the central body (body portion 125) configured to press an inner surface of the implant to dilate the implant (stent 147) (paragraph [0056]);
The implant (stent 147) having the inner surface and positioned on the central body (body portion 125) (paragraph [0056]); and
A lubricious exterior surface of the inflatable body that contacts the inner surface of the implant (subsection of lubricant coating 160, as can be seen in figs. 8 and 11E, that is on the exposed portion of the outer fold regions 155 that will come into contact with the stent 147) positioned at the central body (body portion 125) when the inflatable body (balloon 105) is deflated (paragraphs [0053, 0074, 0077]), and a lubricious exterior surface of the inflatable body that is between the folds of the inflatable body (subsection of lubricant coating 160, as can be seen in figs. 8 and 11E, that folded underneath an adjacent wing 190) when the inflatable body (balloon 105) is deflated (paragraphs [0053, 0074, 0077]).
PNG
media_image1.png
372
566
media_image1.png
Greyscale
With respect to claim 12:
Wherein the lubricious exterior surface of the inflatable body that is between the folds of the inflatable body (subsection of lubricant coating 160, as can be seen in figs. 8 and 11E, that folded underneath an adjacent wing 190) comprises a lubricious coating (lubricant coating 160) on the inflatable body (balloon 105) (paragraphs [0053, 0074, 0077]).
With respect to claim 13:
Wherein the lubricious coating (lubricant coating 160) comprises a biocompatible material (paragraph [0058]).
With respect to claim 14:
Wherein the biocompatible material comprises a silicone-based lubricant (silicone hydrophobic material) (paragraph [0058]).
With respect to claim 15:
Wherein the lubricious exterior surface of the inflatable body that is between the folds of the inflatable body (subsection of lubricant coating 160, as can be seen in figs. 8 and 11E, that folded underneath an adjacent wing 190) comprises a surface thermally bonded to the inflatable body (balloon 105). (PLEASE NOTE: Claim 15 is a product by process claim. Patentable weight has only been given to the structure of the end product, not to the method of manufacture. The end product being considered a bonded connection between the lubricious exterior surface (lubricant coating 160) and the inflatable body (balloon 105). Manufacturing steps such as thermal bonding are not given patentable weight in the claim. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.)
With respect to claim 16:
Wherein the lubricious exterior surface of the inflatable body that is between the folds of the inflatable body (subsection of lubricant coating 160, as can be seen in figs. 8 and 11E, that folded underneath an adjacent wing 190) comprises a textured surface (the lubricant coating (160) is not uniform on the outer surface of the balloon (105), thus creating regions without lubricant coating (160)/ outer fold regions (155); as such, the exterior surface of balloon is considered by Examiner to be “textured” (has protrusions of the lubricant coating (160))).
Claim(s) 1-2, 4, 6-8, 10, 17-18, 20-21 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Stupecky et al. (US 2016/0008589 A1 – as previously cited).
With respect to claim 1:
Stupecky et al. discloses a dilation device (catheter), as can be seen in fig. 31, for an implant (stent), the dilation device (catheter) comprising:
An inflatable body (nested balloon 2) having a proximal end (at proximal neck weld 4) and a distal end (opposite to proximal neck weld) (paragraph [0186]), and a central body (portion of nested balloon 2 with a constant diameter) positioned between the proximal end (at proximal neck weld 4) and the distal end (opposite to proximal neck weld) and having a length, the central body (portion of nested balloon 2 with a constant diameter) configured to press an inner surface of the implant (stent) to dilate the implant (stent) (paragraph [0112]), the inflatable body (nested balloon 2) including at least one outer inflatable body fold radius of curvature greater than or equal to one half a thickness of the inflatable body when the inflatable body is deflated (the fold curvature is the outer curve of each flute, as seen in the modified figure below; thus the radius of the fold curvature is measured from the center point, labelled as 10c, to the outer edge of the outer curve of the flute; therefore, this measurement must be at least the thickness of the inflatable body (nested balloon 2) but not significantly more than the thickness as Stupecky et al. is focused on reducing the (bend radius 10) to as small as possible.).
PNG
media_image2.png
366
366
media_image2.png
Greyscale
With respect to claim 2:
Wherein the at least one outer inflatable body fold radius of curvature is greater than the thickness of the inflatable body (nested balloon 2) (the fold curvature is the outer curve of each flute, as seen in the modified figure above; thus the radius of the fold curvature is measured from the center point, labelled as 10c, to the outer edge of the outer curve of the flute; therefore, this measurement must be at least the thickness of the inflatable body (nested balloon 2) but not significantly more than the thickness as Stupecky et al. is focused on reducing the (bend radius 10) to as small as possible.).
With respect to claim 4:
Wherein the at least one outer inflatable body fold radius of curvature is between one and five times the thickness of the inflatable body (nested balloon 2) (the fold curvature is the outer curve of each flute, as seen in the modified figure above; thus the radius of the fold curvature is measured from the center point, labelled as 10c, to the outer edge of the outer curve of the flute; therefore, this measurement must be at least the thickness of the inflatable body (nested balloon 2) but not significantly more than the thickness as Stupecky et al. is focused on reducing the (bend radius 10) to as small as possible.)
With respect to claim 6:
Wherein the inflatable body (nested balloon 2) includes an interior lumen for fluid flow (there inherently must be an inflation lumen to inflate the nested balloon 2).
With respect to claim 7:
Wherein the inflatable body (nested balloon 2) includes a plurality of folds (plurality of flutes) (paragraph [0177]).
With respect to claim 8:
Wherein the plurality of folds (plurality of flutes) are configured to unfurl during inflation of the inflatable body (nested balloon 2) (paragraphs [0029, 0096]).
With respect to claim 10:
Wherein the inflatable body (nested balloon 2) includes a distal shoulder (tapering between the constant larger diameter and the distal neck weld/ opposite to proximal neck weld), as can be seen in fig. 31.
With respect to claim 17:
An inflatable body (nested balloon 2) coupled to the delivery apparatus (proximal shaft) and having a proximal end (at proximal neck weld 4) and a distal end (opposite to proximal neck weld) (paragraph [0186]), and a central body (portion of nested balloon 2 with a constant diameter) positioned between the proximal end (at proximal neck weld 4) and the distal end (opposite to proximal neck weld) and having a length, the central body (portion of nested balloon 2 with a constant diameter) configured to press an inner surface of the implant (stent) to dilate the implant (stent) (paragraph [0112]), the inflatable body (nested balloon 2) including at least one outer inflatable body fold radius of curvature greater than or equal to one half a thickness of the inflatable body when the inflatable body is deflated (the fold curvature is the outer curve of each flute, as seen in the modified figure above; thus the radius of the fold curvature is measured from the center point, labelled as 10c, to the outer edge of the outer curve of the flute; therefore, this measurement must be at least the thickness of the inflatable body (nested balloon 2) but not significantly more than the thickness as Stupecky et al. is focused on reducing the (bend radius 10) to as small as possible.).
With respect to claim 18:
Wherein the at least one outer inflatable body fold radius of curvature is greater than the thickness of the inflatable body (nested balloon 2) (the fold curvature is the outer curve of each flute, as seen in the modified figure above; thus the radius of the fold curvature is measured from the center point, labelled as 10c, to the outer edge of the outer curve of the flute; therefore, this measurement must be at least the thickness of the inflatable body (nested balloon 2) but not significantly more than the thickness as Stupecky et al. is focused on reducing the (bend radius 10) to as small as possible.).
With respect to claim 20:
Wherein the at least one outer inflatable body fold radius of curvature is between one and five times the thickness of the inflatable body (nested balloon 2) (the fold curvature is the outer curve of each flute, as seen in the modified figure above; thus the radius of the fold curvature is measured from the center point, labelled as 10c, to the outer edge of the outer curve of the flute; therefore, this measurement must be at least the thickness of the inflatable body (nested balloon 2) but not significantly more than the thickness as Stupecky et al. is focused on reducing the (bend radius 10) to as small as possible.)
With respect to claim 21:
Wherein a pleated inside diameter (diameter of the inner most surface of the balloon when compressed, as seen in fig. 3B) of the inflatable body (nested balloon 2) is greater than a pleat height (distant between the inner most surface of the balloon and the outer most surface of the balloon when compressed, as seen in fig. 3B) of the inflatable body (nested balloon 2) (Although Stupecky et al. does not recite the figures being drawn to scale, the figures are schematic and must accurately represent the invention as disclosed; as such, the much larger pleated inside diameter (diameter of the inner most surface of the balloon when compressed, as seen in fig. 3B) of the inflatable body (nested balloon 2) than the pleat height (distant between the inner most surface of the balloon and the outer most surface of the balloon when compressed, as seen in fig. 3B) of the inflatable body (nested balloon 2) can be clearly seen in fig. 3B).
Claim(s) 1-8, 17-19 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Eidenschink et al. (US 2007/0129748 A1).
With respect to claim 1:
Eidenschink et al. discloses a dilation device (catheter), as can be seen in figs. 5-6, for an implant (stent), the dilation device (catheter) comprising:
An inflatable body (balloon 10) having a proximal end and a distal end, and a central body positioned between the proximal end and the distal end and having a length, the central body configured to press an inner surface of the implant (stent) to dilate the implant (stent) (paragraphs [0049-0050]), the inflatable body (balloon 10) including at least one outer inflatable body fold radius of curvature greater than or equal to one half a thickness of the inflatable body when the inflatable body is deflated (the fold curvature is one of the outer curves of each fold, as seen in the modified figure below there are two potential “fold curvatures”; thus the radius of the fold curvature is measured from the center point of each of these respective curves, to the outer edge of the outer curve of the respective curve – which in one case will include at least two layers/ thickness of the balloon plus potentially the thickness of the coating between the layers and in another case, where there is no fluid in the deflated balloon a single thickness layer of the balloon.).
PNG
media_image3.png
398
608
media_image3.png
Greyscale
With respect to claim 2:
Wherein the at least one outer inflatable body fold radius of curvature is greater than the thickness of the inflatable body (balloon 10). (the fold curvature is one of the outer curves of each fold, as seen in the modified figure above; thus the radius of the fold curvature is measured from the center point of that curve, to the outer edge of the outer curve of the fold – which will include at least two layers/ thickness of the balloon plus potentially the thickness of the space therebetween.).
With respect to claim 3:
Wherein the at least one outer inflatable body fold radius of curvature is greater than two times the thickness of the inflatable body (balloon 10). (the fold curvature is one of the outer curves of each fold, as seen in the modified figure above; thus the radius of the fold curvature is measured from the center point of that curve, to the outer edge of the outer curve of the fold – which will include at least two layers/ thickness of the balloon plus potentially the thickness of the space therebetween.).
With respect to claim 4:
Wherein the at least one outer inflatable body fold radius of curvature is between one and five times the thickness of the inflatable body (balloon) (the fold curvature is one of the outer curves of each fold, as seen in the modified figure above; thus the radius of the fold curvature is measured from the center point of the curve to the outer edge of the outer curve – which when there is no fluid in the deflated balloon is a single thickness layer of the balloon.)
With respect to claim 5:
Wherein the at least one outer inflatable body fold radius of curvature is between one half and the thickness of the inflatable body (balloon) (the fold curvature is one of the outer curves of each fold, as seen in the modified figure above; thus the radius of the fold curvature is measured from the center point of the curve to the outer edge of the outer curve – which when there is no fluid in the deflated balloon is a single thickness layer of the balloon.)
With respect to claim 6:
Wherein the inflatable body (balloon 10) includes an interior lumen for fluid flow (there inherently must be an inflation lumen to inflate the balloon 10).
With respect to claim 7:
Wherein the inflatable body (balloon 10) includes a plurality of folds (as can be seen in fig. 6).
With respect to claim 8:
Wherein the plurality of folds are configured to unfurl during inflation of the inflatable body (balloon 10), as can be seen in fig. 5 (paragraphs [0029, 0096]).
With respect to claim 17:
Eidenschink et al. discloses an implant delivery device, as can be seen in figs. 5-6, comprising:
A delivery device (catheter); and
An inflatable body (balloon 10) having a proximal end and a distal end, and a central body positioned between the proximal end and the distal end and having a length, the central body configured to press an inner surface of the implant (stent) to dilate the implant (stent) (paragraphs [0049-0050]), the inflatable body (balloon 10) including at least one outer inflatable body fold radius of curvature greater than or equal to one half a thickness of the inflatable body when the inflatable body is deflated (the fold curvature is one of the outer curves of each fold, as seen in the modified figure above there are two potential “fold curvatures”; thus the radius of the fold curvature is measured from the center point of each of these respective curves, to the outer edge of the outer curve of the respective curve – which in one case will include at least two layers/ thickness of the balloon plus potentially the thickness of the coating between the layers and in another case, where there is no fluid in the deflated balloon a single thickness layer of the balloon.).
With respect to claim 18:
Wherein the at least one outer inflatable body fold radius of curvature is greater than the thickness of the inflatable body (balloon 10). (the fold curvature is one of the outer curves of each fold, as seen in the modified figure above; thus the radius of the fold curvature is measured from the center point of that curve, to the outer edge of the outer curve of the fold – which will include at least two layers/ thickness of the balloon plus potentially the thickness of the space therebetween.).
With respect to claim 19:
Wherein the at least one outer inflatable body fold radius of curvature is greater than two times the thickness of the inflatable body (balloon 10). (the fold curvature is one of the outer curves of each fold, as seen in the modified figure above; thus the radius of the fold curvature is measured from the center point of that curve, to the outer edge of the outer curve of the fold – which will include at least two layers/ thickness of the balloon plus potentially the thickness of the space therebetween.).
With respect to claim 20:
Wherein the at least one outer inflatable body fold radius of curvature is between one and five times the thickness of the inflatable body (balloon) (the fold curvature is one of the outer curves of each fold, as seen in the modified figure above; thus the radius of the fold curvature is measured from the center point of the curve to the outer edge of the outer curve – which when there is no fluid in the deflated balloon is a single thickness layer of the balloon.)
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/REBECCA S PRESTON/ Examiner, Art Unit 3774
Prosecution Insights