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 on March 12, 2026 is being considered by the examiner.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 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], undergoing deformation; balloon 18 may be formed of compliant material [0044], which is an elastic/extensible material, such that when compliant ballon 18 is inflated, the balloon would stretch, increasing the distance between the knobs 226, undergoing migration).
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, and 15-19 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Sirhan et al. (US2022/0338889).
Regarding claim 12, Sirhan discloses a medical device comprising: an inflatable balloon; and a textured sleeve disposed on an exterior surface of the inflatable balloon (scaffold 10 may be balloon expandable [0075, 0513]), wherein the textured sleeve includes a plurality of protrusions extending from a surface of the textured sleeve (Fig. 1A &1B: scaffold 10 includes stress-applying features 24 [0514]), wherein the textured sleeve is configured to expand with the inflatable balloon such that the plurality of protrusions undergo strain-responsive transformation (radial expansion of scaffold cause by balloon expansion [0513]; features 24 migrate further from one another when scaffold is expanded, as seen in Fig. 1B).
Regarding claim 13, Sirhan 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 (Fig. 1A & 1B: scaffold 10 is a tubular body; although not illustrated, it is highly suggested that the balloon would extend through the scaffold to expand the scaffold, as scaffold 10 is balloon expandable).
Regarding claim 15, Sirhan discloses the medical device of claim 12, further disclosing wherein the textured sleeve is coupled to the inflatable balloon (Fig. 1A & 1B: scaffold may be balloon expandable [0513], thus would be coupled to one another).
Regarding claim 16, Sirhan discloses the medical device of claim 12, 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 (Fig. 1A & 1B: scaffold 10 expands upon inflation of balloon, resulting in the stress-applying features 24 to move apart from one another, experiencing migration).
Regarding claim 17, Sirhan discloses the medical device of claim 12, 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 (Fig. 1A & 1B: scaffold 10 expands upon inflation of balloon, resulting in the stress-applying features 24 to move apart from one another, experiencing migration, thus during deflation, the stress-applying features move closer to one another, experiencing migration).
Regarding claim 18, Sirhan discloses the medical device of claim 12, 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 (stress-applying features can be enhanced to intensify friction to the surface of a vessel or calcified lesion to minimize mispositioning or sliding of the expandable structure [0060]).
Regarding claim 19, Sirhan discloses the medical device of claim 18, 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 (degree of engagement between the stress-applying features and the vessel/calcified lesion is dependent on the level of inflation of the expandable structure/balloon, as a deflated configuration would prevent the stress-applying features from contacting the surface of the vessel/calcified lesion).
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.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Grayzel et al. (US2002/0010489).
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]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Sirhan in view of Mareiro et al. (US6,258,099).
Regarding claim 20, Sirhan discloses the medical device of claim 12, but fails to 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, Mareiro teaches an inflatable balloon, a sleeve disposed on an exterior surface of the inflatable balloon (Fig. 1: stent 160 disposed on the outer surface of balloon 100 [col. 3, lines 53-54]), wherein the sleeve is configured to expand with the inflatable ballon (balloon expandable stent [col. 4, line 28]), further teaching wherein the exterior surface of the inflatable balloon is textured to increase retention of the sleeve on the inflatable balloon (protrusions may extend outward from the balloon in both the uninflated state and in the inflated state [col. 4, lines 22-24]; protrusions engage portions of the stent [col. 4, lines 1-4]; improve stent retention [col. 4, lines 31). 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 texturing components on the balloon of Mareiro to the balloon of Sirhan, as it is known in the art to help anchor the scaffold to the balloon, preventing undesired slippage or movement [col. 1, lines 53-56].
Response to Arguments
Applicant's arguments filed May 4, 2026 regarding the rejection of claims 1-6 in view of Wu (US2014/0277071) have been fully considered but they are not persuasive. Applicant has amended claim 1 to require that the plurality of protrusions is configured to undergo a transformation including both deformation and migration in response to a change in strain and has argued that the knobs 224 on the balloon of Wu do not experience migration. The examiner respectfully disagrees. Balloon 218 in Fig. 5 of Wu, similarly structured to the balloon 18, may be formed of compliant, semi-compliant or non-compliant material [0044]. In the instance where balloon 218 is formed of compliant material, the balloon will elastically stretch upon inflation and the knobs 224 on the exterior of balloon 218 would migrate further from one another. In the instance where balloon 218 is formed from non-complaint material, the balloon will not elastically stretch upon inflation. Therefore, the examiner has interpreted the balloon 218 to be formed of compliant material that would stretch upon inflation, allowing the plurality of protrusions to undergo transformation including deformation and migration.
Applicant’s arguments with respect to the rejection(s) of claims 12, 13, 15-19 in view of Grayzel (US2002/0010489) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sirhan and Mareiro.
Conclusion
THIS ACTION IS MADE FINAL. 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 LI-TING SONG whose telephone number is (571)272-5771. The examiner can normally be reached 8-5.
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/LI-TING SONG/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795 08/07/26
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