DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Claim Rejections - 35 USC § 102
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, 3, 4-6, 8-10, 17 and 21-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2009158276 A2 to Clarke et al. (Clarke).
Clarke discloses:
Regarding claim 1:
A method for treating a medical device (see the method outlined in ¶0143), the method comprising:
disposing an annealing fluid (“a pool of solvent in an air- filled chamber”, ¶0143) in a closed chamber (“sealed chamber containing a solvent containing atmosphere”, ¶0143);
allowing the annealing fluid to reach a liquid-gas equilibrium within the chamber (“allowing a pool of solvent in an air- filled chamber to come to equilibrium (saturation) at a given temperature”, ¶0143); and
disposing a drug coated medical device within the closed chamber (“Upon introduction of the device to the chamber, the solvent may wet the drug particles, leading to drug dissolution and flow”, ¶0143);
wherein the drug coated medical device has a drug layer with an initial drug coating durability prior to disposing the drug coated medical device within the closed chamber (¶0113 indicates the medical device is seeded with drug particles or has a layer of drug particles before the it annealed in the closed chamber; further, since is does have a drug layer as required by the claim it also must inherently have a durability as required by the claim);
wherein the drug layer includes drug microcrystals (¶0113 indicates the drug layer includes micro-sized crystalline particles); and
wherein after disposing the drug coated medical device within the closed chamber, the drug layer is annealed such that the drug layer has an annealed drug coating durability greater than the initial drug coating durability (this is an inherent function of the annealing process as described in the steps and further ¶0135 indicates that the coating becomes hard and brittle after the annealing process indicating that the durability/hardness of the coating has increased).
Regarding claim 3:
The method of claim 1, wherein the closed container (“sealed chamber”, ¶0143) has a base (inherent, sealed chamber must have a base) and wherein disposing an annealing fluid (“a pool of solvent”, ¶0143) in a closed chamber (“sealed chamber”, ¶0143) includes coating the base with the annealing fluid (“a pool of solvent in an air- filled chamber”, ¶0143).
Regarding claim 4:
The method of claim 3, wherein coating the base with the annealing fluid includes coating the base to form a layer of the annealing fluid that is 1-10 millimeters thick (interpreted as intended use and the chamber disclosed in ¶0143 is capable of this function since it is a sealed and enclosed chamber).
Regarding claim 5:
The method of claim 1, wherein allowing the annealing fluid to reach the liquid-gas equilibrium within the chamber includes partially evaporating the annealing fluid (“Such an atmosphere may be formed, for example, by allowing a pool of solvent in an air- filled chamber to come to equilibrium (saturation) at a given temperature (e.g., room temperature or above)”, ¶0143).
Regarding claim 6:
The method of claim 1, wherein allowing the annealing fluid to reach the liquid-gas equilibrium within the closed chamber includes partially evaporating the annealing fluid for at least two hours (interpreted as intended use and the chamber disclosed in ¶0143 is capable of this function in order to reach steady state).
Regarding claim 8:
The method of claim 1, wherein the drug coated medical device includes a drug coating (“Upon introduction of the device to the chamber, the solvent may wet the drug particles, leading to drug dissolution and flow”, ¶0143), and wherein disposing the drug coated medical device within the closed chamber includes vapor annealing the drug coating (“A simple system for solvent annealing may include a sealed chamber containing a solvent containing atmosphere”, ¶0143).
Regarding claim 9:
The method of claim 8, wherein the drug coating includes everolimus (“Therapeutic agents also include … everolimus”, ¶0036).
Regarding claim 10:
The method of claim 1, wherein the drug coated medical device includes a drug coated balloon (“Examples of medical devices benefiting from the various aspects of the present invention vary widely and include implantable or insertable medical devices, for example, … catheters (e.g., urological catheters or vascular catheters such as balloon catheters”, ¶0024).
Regarding claim 17:
A method for treating a medical device, the method comprising:
forming a vapor annealing chamber (“sealed chamber containing a solvent containing atmosphere”, ¶0143) by disposing a layer of isopropyl alcohol within a container (“allowing a pool of solvent in an air- filled chamber to come to equilibrium (saturation) at a given temperature”, ¶0143) and allowing the layer of isopropyl alcohol to partially evaporate and reach a liquid- gas equilibrium (“Such an atmosphere may be formed, for example, by allowing a pool of solvent in an air- filled chamber to come to equilibrium (saturation) at a given temperature (e.g., room temperature or above)”, ¶0143);
disposing an everolimus (“Therapeutic agents also include … everolimus”, ¶0036) coated balloon (“Examples of medical devices benefiting from the various aspects of the present invention vary widely and include implantable or insertable medical devices, for example, … catheters (e.g., urological catheters or vascular catheters such as balloon catheters”, ¶0024) within the vapor annealing chamber (“sealed chamber containing a solvent containing atmosphere”, ¶0143);
wherein the everolimus coated balloon includes a drug layer with everolimus microcrystals (¶0113 indicates the drug layer includes micro-sized crystalline particles) having a width less than 3 micrometers (¶0040 indicates the Therapeutic-agent-containing layer (drug layer) can be between 10nm to 10μm);
vapor annealing the everolimus coated balloon within the vapor annealing chamber; (“A simple system for solvent annealing may include a sealed chamber containing a solvent containing atmosphere”, ¶0143) and
removing the vapor annealed everolimus coated balloon from the vapor annealing chamber (“The device is removed from the chamber after a desired period of exposure to the chamber atmosphere”, ¶0143);
wherein the drug layer has an initial durability prior to vapor annealing the everolimus coated balloon (¶0113 indicates the medical device is seeded with drug particles or has a layer of drug particles before the it annealed in the closed chamber; further, since is does have a drug layer as required by the claim it also must inherently have a durability as required by the claim); and
wherein after removing the vapor annealed everolimus coated balloon from the vapor annealing chamber, the drug layer has an annealed durability greater than the initial durability (this is an inherent function of the annealing process as described in the steps and further ¶0135 indicates that the coating becomes hard and brittle after the annealing process indicating that the durability/hardness of the coating has increased).
Regarding claim 21:
The method of claim 1, wherein the drug layer has a dry, powder-like morphology prior to disposing the drug coated medical device within the closed chamber (¶0113 indicates the crystals are milled to a pre-determined size of particles (powder) which are then deposited on the device surface).
Regarding claim 22:
The method of claim 21, wherein the drug layer has a wet-like, smooth morphology after disposing the drug coated medical device within the closed chamber (¶0143 indicates that during the annealing process the solvent wets the drug particles and causes them to flow and further ¶0126 indicates the particulate layer made flat and smooth as shown in figures 16-19).
Regarding claim 23:
The method of claim 17, wherein the drug layer has a dry, powder-like morphology prior to vapor annealing the everolimus coated balloon (¶0113 indicates the crystals are milled to a pre-determined size of particles (powder) which are then deposited on the device surface).
Regarding claim 24:
The method of claim 23, wherein the drug layer has a wet-like, smooth morphology after removing the vapor annealed everolimus coated balloon from the vapor annealing chamber (¶0143 indicates that during the annealing process the solvent wets the drug particles and causes them to flow and further ¶0126 indicates the particulate layer made flat and smooth as shown in figures 16-19).
Claim Rejections - 35 USC § 103
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2009158276 A2 to Clarke et al. (Clarke) as applied to claim 1 above, and further in view of US 20200230373 A1 to Stankus et al. (Stankus).
Regarding claim 2:
Clarke fails to disclose:
The method of claim 1, wherein the annealing fluid comprises isopropyl alcohol.
Stankus teaches:
An annealing method that includes solvent vapor annealing (¶0134) that uses isopropyl alcohol as the annealing fluid (¶0134).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clarke to further include isopropyl alcohol as the annealing fluid as taught by Stankus. This is a simple substitution of one known element (annealing fluid of Clarke) for another (isopropyl alcohol annealing fluid as taught by Stankus) to obtain predictable results (to anneal a medical device).
Claim(s) 7, 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2009158276 A2 to Clarke et al. (Clarke) as applied to claims 1 and 17 above, and further in view of US 20100272773 A1 to Kangas et al. (Kangas).
Regarding claim 7:
Clarke fails to disclose:
The method of claim 1, wherein disposing the drug coated medical device within the closed chamber includes disposing the drug coated medical device within the closed chamber for at least two hours.
Kangas teaches:
A coated medical device method that includes annealing (¶0099). The annealing process can take 4 hours (¶0099). Further, the coating process of the medical device can be performed folded or expanded (¶0060).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clarke to further include the annealing process taking 4 hours (at least 2 hours) as taught by Kangas in order for the annealing process to change the coating from an amorphous to crystalline structure (¶0096).
Regarding claim 18:
Clarke fails to disclose:
The method of claim 17, wherein disposing the everolimus coated balloon within the vapor annealing chamber includes disposing the everolimus coated balloon within the vapor annealing chamber while the everolimus coated balloon is in a folded configuration.
Kangas teaches:
A coated medical device method that includes annealing (¶0099). The annealing process can take 4 hours (¶0099). Further, the coating process of the medical device can be performed folded or expanded (¶0060).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clarke to further include the annealing process taking place with the balloon catheter folded as taught by Kangas in order for the annealing process to change the coating from an amorphous to crystalline structure (¶0096).
Regarding claim 19:
Clarke fails to disclose:
The method of claim 17, wherein disposing the everolimus coated balloon within the vapor annealing chamber includes disposing the everolimus coated balloon within the vapor annealing chamber while the everolimus coated balloon is in an inflated configuration.
Kangas teaches:
A coated medical device method that includes annealing (¶0099). The annealing process can take 4 hours (¶0099). Further, the coating process of the medical device can be performed folded or expanded (¶0060).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clarke to further include the annealing process taking place with the balloon catheter inflated/expanded as taught by Kangas in order for the annealing process to change the coating from an amorphous to crystalline structure (¶0096).
Claim(s) 11 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2009158276 A2 to Clarke et al. (Clarke) as applied to claims 1 and 17 above, and further in view of US 20160213890 A1 to Kaufman et al. (Kaufman).
Regarding claim 11:
Clarke fails to disclose:.
The method of claim 1, after disposing the drug coated medical device within the closed chamber, removing the drug coated medical device from the chamber and sterilizing the drug coated medical device.
Kaufman teaches:
A method that includes solvent vapor annealing (¶0112) that further includes a sterilizing process by electron beam irradiation after the annealing process (¶0112).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clarke to further include an electron beam irradiation process after the annealing process as taught by Kaufman in order to sterilize the medical device (Kaufman, ¶0112).
Regarding claim 20:
Clarke fails to disclose:
The method of claim 17, after removing the vapor annealed everolimus coated balloon from the vapor annealing chamber, sterilizing the vapor annealed everolimus coated balloon.
Kaufman teaches:
A method that includes solvent vapor annealing (¶0112) that further includes a sterilizing process by electron beam irradiation after the annealing process (¶0112).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Clarke to further include an electron beam irradiation process after the annealing process as taught by Kaufman in order to sterilize the medical device (Kaufman, ¶0112).
Response to Arguments
Applicant's arguments filed 7/28/26 have been fully considered but they are not persuasive.
Regarding the 35 USC 102 claim rejections:
The applicant has argued that the amendments made to the claims are not taught by the reference and for this reason the rejections should be withdrawn. However, as indicated above these amendments are taught by the reference and for this reason the above rejections are maintained.
Regarding the claim objections:
The applicants’ amendments to the claims have addressed the previous claim objections and for this reason they have been withdrawn.
Regarding the 35 USC 112(b) claim rejections:
The applicant’s amendments to the claims have addressed the previous claim objections and for this reason they have been withdrawn.
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 WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
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