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
Applicant's arguments filed 2/27/2026 have been fully considered but they are not persuasive.
In response to applicant's arguments on pages 5-8 against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The amended claims have been rejected under a combination of Murray, Barbick and Davison. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
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) 1, 6-9, and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over USPAP 2006/0265040 (Murray) in view of USPAP 2013/0303983 (Barbick et al.), and further in view of USPAP 2022/0031915 (Davison et al.).
Murray discloses a medical device delivery system (20) comprising a catheter shaft (24) having a proximal end and a distal end portion;
an expandable member (balloon 34) provided at the distal end portion of the shaft (24), the expandable member having a delivery configuration and a deployed configuration [0017];
the expandable member being folded around the catheter shaft in its delivery configuration (See Fig. 1-4; [0022]);
characterized in that a coating (40) is disposed on at least a portion of the outer surface area of the expandable member (34) in its delivery configuration such that the coating does not cover portions of the expandable member located inside the folds (42) of the expandable member in its delivery configuration (see cross-section of Figure 3-5; [0023]);
and an expandable medical device (stent 22) is mounted on the expandable member in the delivery configuration with the coating being disposed between the expandable member and the expandable medical device (see cross-section of Figure 3-5; [0018]).
Murray fails to disclose the coating (40) is applied by spraying. Barbick discloses another balloon catheter, wherein the balloon (24) is folded about the shaft (22) [0062; 0067] and a coating (26) is only present on the outer surface of the balloon and does not cover the portions inside the folds (see Fig. 5a; [0070]). Barbick teaches that this arrangement of a coating is achieved by spray coating the balloon while it is in the folded condition [0070]. One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to achieve the coating (40) segments of Murray by spraying the balloon while it is in the folded condition, as taught by Barbick, as this modification involves a combination of known methods of applying a coating to a balloon that obtains a predictable result of achieving a coating on outer surfaces of folds of a balloon and that does not cover the interior portions of the folds.
Murray discloses the coating (40) can be a polyurethane material [0021], but Murray and Barbick fail to disclose the particular material spray coating composition being a thermoplastic polyurethane. Davison discloses polyurethane coatings applied to medical devices (abstract) that provide the benefits of radiopacity for visualization, enhanced mechanical properties [0022]. Similar to Barbick, the coating solutions may be applied to medical devices by spraying [0312-0317]. Davison teaches the spray coating comprises a thermoplastic polycarbonate polyurethane elastomer (Carbosil or Bionate; [0090 – 0091]).
One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to form the coating of modified Murray from a solution comprising thermoplastic polycarbonate polyurethane, as Davison teaches this coating material has desirable mechanical properties for medical devices. Further, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
In regards to claim 6, Davison teaches the spray coating consists of a thermoplastic polycarbonate polyurethane elastomer (Carbosil or Bionate; [0090 – 0091]).
Regarding claim 7, Murray discloses the coating (40) has a thickness of 0.6 mm [0021].
Regarding claim 8, Murry discloses the medical device is a stent graft.
Regarding claim 12, Murray, Barbick and Davison disclose the claimed invention except for the particular solution composition. Davison does teach that the composition amounts the polyurethane and solvent in the solution can vary widely in order to achieve the desired properties of the coating [0014; 0031-0032; 0071]. It is also noted that Applicant does not disclose any criticality for the claimed range, but rather discloses a wide range of amounts of thermoplastic polyurethane in the solution (page 14, lines 12-22). Therefore, one of ordinary skill in the art would have found it obvious to use a solution comprising 50-200 g/l of the polycarbonate-based thermoplastic polyurethane taught by Davison in hexafluoroisopropanol (see Davison [0068]), in order to obtain the desired properties of the coating. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 13, Davison teaches that the coating can be applied in a series of thin layers applied in multiple steps to build the desired thickness [0093]. Additionally, Barbick discloses multiple coating steps to achieve the desired thickness [0055].
Regarding claim 14, Barbick teaches that the device can be masked to prevent application of the coating to masked areas [0055]. Therefore, it would have been further obvious to utilize a mask during the modified Murray process to achieve the desired coating pattern.
Regarding claim 15, Barbick teaches that the device can be rotated during spraying [0055]. Therefore, it would have been further obvious to rotate the folded medical device during the modified Murray process of applying the coating to achieve the desired coating properties.
Regarding claims 16 and 17, Barbick teaches that polyamide is a suitable material for forming an expandable balloon [0033]. It would have been obvious to one of ordinary skill in the art at the time the invention was made to form the balloon of modified Murray from polyamide, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
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 SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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