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 .
Information Disclosure Statement
The information disclosure statement (IDS) filed October 16, 2025 is being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the closed end of the textured sleeve feature of claim 14 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Wu et al. (US2014/0277071).
Regarding claim 1, Wu discloses a medical device comprising: a selectively strainable surface (inflatable balloon 218, similar to balloon 118 [0063]); and a plurality of protrusions extending from the selectively strainable surface (Fig. 5: plurality of knobs 226 cover balloon 218 [0063]), wherein one or more protrusions of the plurality of protrusions are configured to undergo a transformation including at least one of deformation and migration in response to a change in strain of the selectively strainable surface (knobs 226 may be molded on the balloon 218 such that knobs 226 expands as balloon 218 expands [0063]).
Regarding claim 2, Wu discloses the medical device of claim 1, further disclosing wherein the selectively strainable surface is an exterior surface of an inflatable balloon, and wherein the change in strain results from inflating or deflating the balloon (balloon 218 expands [0063], similar to balloon 118 through inflation).
Regarding claim 3, Wu discloses the medical device of claim 1, further disclosing wherein the transformation includes at least one of uniaxial migration and uniaxial deformation (knobs 226 may expand as balloon 218 expands [0063], undergoing at least biaxial migration and biaxial deformation).
Regarding claim 4, Wu discloses the medical device of claim 1, further disclosing wherein the transformation includes at least one of biaxial migration and biaxial deformation (knobs 226 may expand as balloon 218 expands [0063], undergoing at least biaxial migration and biaxial deformation).
Regarding claim 5, Wu discloses the medical device of claim 1, further disclosing wherein one or more protrusions of the plurality of protrusions are positioned to engage an inner surface of a physiological lumen to increase a frictional coupling between the medical device and the inner surface of the physiological lumen (knobs 226 extend outwardly from working length 224 to increase friction between balloon 218 and an airway [0063]).
Regarding claim 6, Wu discloses the medical device of claim 5, further disclosing wherein a degree of engagement between the medical device and the inner surface of the physiological lumen is responsive to the change in strain of the selectively strainable surface (level of inflation/deflation of balloon 218 would adjust level of friction between balloon 218/knobs 226 and airway [0063]).
Claims 12, 13, 15-19 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Grayzel et al. (US2002/0010489).
Regarding claim 12, Grayzel discloses a medical device comprising: an inflatable balloon (balloon 14); and a textured sleeve disposed on an exterior surface of the inflatable balloon, wherein the textured sleeve includes a plurality of protrusions extending from a surface of the textured sleeve (stiffening member 16 may be constructed as part of a sleeve or sheath that is fit over balloon 14 or as part of sheet that is wrapped around balloon 14 [0051]; stiffening members 16 may include one or more projections 48 [0058]).
Regarding claim 13, Grayzel discloses the medical device of claim 12, further disclosing wherein the textured sleeve includes a tubular body and the inflatable balloon extends through the textured sleeve (stiffening member 16 may be constructed as part of a sleeve, a tubular shape, or sheath that is fit over balloon 14 [0051], allowing balloon 14 to extend through the sleeve).
Regarding claim 15, Grayzel discloses the medical device of claim 12, further disclosing wherein the textured sleeve is coupled to the inflatable balloon (stiffening member 16 may be constructed as part of a sleeve or sheath that is fit over balloon 14 [0051]; network of projections may form a sheet, sheath or sleeve of projections that may be attached to a balloon [0078]).
Regarding claim 16, Grayzel discloses the medical device of claim 12, further disclosing wherein the plurality of protrusions is configured to undergo at least one of deformation and migration responsive to a change in inflation of the balloon (stiffening members 16 may be formed from a flexible material [0049], and alternatively a material or composite that is flexible in one direction but rigid in another may be utilized [0049], highly suggestive that the stiffener is configured to undergo deformation and migration in response to inflation; projections 48 may be formed of the same flexible material as members 16 [0058]).
Regarding claim 17, Grayzel discloses the medical device of claim 12, further disclosing wherein the plurality of protrusions is configured to undergo at least one of deformation and migration responsive to a change in deflation of the balloon (stiffening members 16 may be formed from a flexible material [0049], and alternatively a material or composite that is flexible in one direction but rigid in another may be utilized [0049], highly suggestive that the stiffener is configured to undergo deformation and migration in response to deflation; projections 48 may be formed of the same flexible material as members 16 [0058]).
Regarding claim 18, Grayzel discloses the medical device of claim 12, further disclosing wherein one or more protrusions of the plurality of protrusions are positioned to engage an inner surface of a physiological lumen to increase a frictional coupling between the inflatable balloon and the inner surface of the physiological lumen (balloon 14 expands radially and stiffening members 16 expands radially and stiffening members 16 contact the inner surface of target lumen [0053], increasing frictional coupling between the balloon 14 and inner surface of target lumen).
Regarding claim 19, Grayzel discloses the medical device of claim 18, further disclosing wherein a degree of engagement between the medical device and the inner surface of the physiological lumen is responsive to one of a change in inflation and a change in deflation of the balloon (stiffening members 16 act to focus the expansion force of balloon 14 at the occlusions in the lumen contacted by member 16, as the interior pressure of balloon 14 is increased, stiffening members 16 engage, cut, pierce or crush the occlusions, facilitating dilation of the target lumen by the expanding balloon [0053]).
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 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Grayzel.
Regarding claim 7, Wu discloses the medical device of claim 1, but fails to disclose wherein one or more protrusions of the plurality of protrusions include a primary body and a secondary body extending from a top surface of the primary body. In the same field of endeavor, Grayzel teaches a substantially similar medical device comprising: a selectively strainable surface (balloon 14); and a plurality of protrusions extending from the selectively strainable surface (stiffening member 16, including projections 48, extend from balloon 14 [0048]), wherein one or more protrusions of the plurality of protrusions are configured to undergo a transformation including at least one of deformation and migration in response to a change in strain of the selectively strainable surface (stiffening members 16 may be formed from a flexible material [0049], and alternatively a material or composite that is flexible in one direction but rigid in another may be utilized [0049], highly suggestive that the stiffener is configured to undergo deformation and migration in response to inflation and deflation; projections 48 may be formed of the same flexible material as members 16 [0058])). Grayzel further teaches wherein one or more protrusion of the plurality of protrusion may include one singular body (Fig. 8A, C, E, F, G, H, I depict various cross-sectional shapes of a stiffening member 16 comprised of a single body) or alternatively include a primary body and a second body extending from a top surface of the primary body (Fig. 8B and D depict two cross-sectional shapes of stiffening member 16 comprised of a primary body 360 and 380 respectively and a second body 362 and 382 respectively extending from a top surface of primary body 360 and 380). In view of Grayzel, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have recognized that the protrusions may alternatively be formed of various shapes or cross-sections, including the protrusion including a primary body and secondary body, as taught by Fig. 8B & D of Grayzel, as the shape and size of the protrusion may depend on the function [0075-0077].
Regarding claim 8, Wu, modified by Grayzel, discloses the medical device of claim 7. Grayzel further teaches wherein the top surface of the primary body is planar (Fig. 8B: top surface of primary body 360 is planar and flat).
Regarding claim 9, Wu, modified by Grayzel, discloses the medical device of claim 7. Grayzel further teaches wherein the top surface of the primary body is non-planar (Fig. 8D: top surface of primary body 380 is non-planar and rounded).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Neal (US2018/0207408)
Regarding claim 10, Wu discloses the medical device of claim 2, but fails to further disclose the medical device comprising an internal baffle extending from an interior surface of the inflatable balloon. In the same field of endeavor, Neal teaches a medical device comprising a strainable surface, wherein the selectively strainable surface is an exterior surface of an inflatable balloon, and wherein the change in strain results from inflating or deflating the balloon (medical balloon 10, formed of an elastic material, includes a plurality of inflatable chambers, which allows the chambers to at least partially expand as a result of fluid pressure [0024]). Neal further teaches the medical device comprising an internal baffle extending from an interior surface of the inflatable balloon (Fig. 1A & 2A: three inflatable chambers 12a-c are formed expandable elastic walls 10a, 10b [0027-0028]). In view of Neal, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the internal baffle, taught by Neal, to the balloon of Wu to create multiple chambers within the balloon, as the multiple chambers allow for selective expanded and manipulated to create variable profiles [0030].
Regarding claim 11, Wu, modified by Neal, discloses the medical device of claim 10. Neal further teaches wherein the internal baffle extends across an internal volume of the inflatable balloon (Fig. 1D & 2A: inner walls 10a extends across an interior volume within the outer wall 10b of balloon 10 [0028]).
Claims 14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Grayzel in view of Kanjickal et al. (US2024/0122733).
Regarding claim 14, Grayzel discloses the medical device of claim 12. Although Grayzel discloses the alternative textured sleeve or sheath, Grayzel fails to further disclose details of the sleeve or sheath thus fails to explicitly disclose wherein the textured sleeve includes a closed end and is disposed over an end of the inflatable balloon. In the same field of endeavor, Kanjickal teaches a medical device comprising: an inflatable balloon (Fig. 1: balloon 108); and a textured sleeve disposed on an exterior surface of the inflatable balloon, wherein the textured sleeve includes a plurality of protrusions extending from a surface of the textured sleeve (Fig. 1: cover 106 may include expandable implant 540 that can be positioned coaxially around balloon 108 and cover 106 [0052]). Kanjickal further teaches wherein the textured sleeve includes a closed end and is disposed over an end of the inflatable balloon (Fig. 1: cover 106 comprises closed ends around the catheter tube 102 at the proximal and distal ends of the cover and cover 106 is disposed over the proximal and distal ends of balloon 106). Since Grayzel fails to disclose the details of the of the sleeve ends, it would have been obvious to one of ordinary skill to have used any known over-the-balloon sleeve end, including the one taught by Kanjickal, as the sleeve end of Grayzel.
Regarding claim 20, Grayzel discloses the medical device of claim 12, but fails to explicitly disclose wherein the exterior surface of the inflatable balloon is textured to increase retention of the textured sleeve on the inflatable balloon. In the same field of endeavor, Kanjickal teaches a medical device comprising: an inflatable balloon (Fig. 1: balloon 108); and a textured sleeve disposed on an exterior surface of the inflatable balloon, wherein the textured sleeve includes a plurality of protrusions extending from a surface of the textured sleeve (Fig. 1: cover 106 may include expandable implant 540 that can be positioned coaxially around balloon 108 and cover 106 [0052]). Further, Kanjickal teaches wherein the exterior surface of the inflatable balloon is textured to increase retention of the textured sleeve on the inflatable balloon (cover 106 can comprise an inner surface that is high friction surface or adhesive coating to facilitate attached of cover 106 to balloon 108 [0038]). In view of Kanjickal, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included wherein the contacting surfaces of the textured sleeve and the balloon experience high friction, as the high friction surfaces facilitate attachment of the cover to the balloon [0038].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See references cited in PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI-TING SONG whose telephone number is (571)272-5771. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LI-TING SONG/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
1/29/26