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 .
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.
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.
Claim(s) 1-2, 4-10, 12-14, 16-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,336,178 (“Kaplan”) in view of U.S. Publication No. 2007/0250035 (“El-Nounou”).
Regarding Claims 1, 7, 8, 12, 13, 16, 18, and 21 Kaplan discloses a medical device (Figs. 4) comprising:
A shaft (20, 70, 76) having a proximal end (see generally Fig. 1C) and a distal end portion (see Fig. 4E), the shaft including a plurality of first lumens (the interior of 32);
An inflatable balloon (84) including a proximal tapered end (see Fig. 4E), a distal tapered end (see Fig. 4E), and a central barrel portion therebetween and mounted on the distal end portion of the shaft (see Fig. 4E); and
a tube (32 – particularly the portions external to 20) associated with each of the plurality of first lumens (see Fig 4E) to thereby define a plurality of such tubes, the tubes extending alongside and attached/bonded to the outer surface the inflatable balloon (see Fig. 4B and 4E) inclusive to the proximal tapered end portion and the central barrel portion (See Fig. 4E), and having one or more delivery ports (34) at a section of the tube extending along the central barrel portion, and a closed distal end (33), wherein each of the plurality of first lumens terminates at a proximal end within a distal portion of the shaft (see Fig. 4E), and wherein the shaft further defines an annular lumen (see generally 58) in communication with the proximal end of each of the plurality of first lumens (see Fig. 4E and 1C).
Kaplan discloses the invention substantially as claimed except that that the annular lumen extends proximal of the proximal end of each of the plurality of first lumens. Rather Kaplan locates the manifold in the proximal end of the shaft, not the distal end in which the proximal end of the first lumens are disposed.
However, El-Nounou discloses a related medical device (10 – Fig. 1) which like that of Kaplan comprises a shaft (12, 25) having a proximal end portion (18) and a distal end portion (25), the shaft including a plurality of lumens (20 – see at Fig. 3) and a longitudinally and radially extending tube (20 – at 14 external to 25) associated with each of plurality of first lumens, the tube having a delivery port (22), wherein each of the plurality of first lumens terminates at a proximal end within a distal portion of the shaft (25 – see Figs. 1-3), and wherein the shaft further defines an annular lumen (24) in communication with the proximal end of each of the plurality of first lumens, said annular lumen extending proximal of the proximal end of each of the plurality of first lumens (see Fig. 3) to thereby define a manifold.
It would have been obvious for one having ordinary skill in the art at the time the invention was made to modify the device of Kaplan such that the annular manifold is located at the distal end of the shaft such that the proximal end of each of the plurality of first lumens is received within the manifold, as disclosed by El-Nounou, as a product of mere obvious design choice pertaining the location of the manifold in a known location to obtain a predictable and expected outcome of routing a single fluid source to a plurality of separate tubular lumens. It has been held that rearranging the location of components of an invention requires only routine and customary skill in the art and is obvious, see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) and it has been held that simple substitution of known equivalents to obtain a predicted and expected outcome is also obvious requiring only routine and customary levels of understanding and skill, see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Here the prior art of El-Nounou establishes a manifold located at the distal end of the shaft (instead of the proximal end) is a suitable, obvious, and known alternative configuration/location for achieving the same expected and predicable outcome.
Regarding Claims 2 and 14, Kaplan discloses the plurality of first lumens surround a central lumen (70, 78) of the shaft (see Fig. 4E).
Regarding Claim 4, Kaplan discloses the plurality of first lumens may comprise eight lumens (see Col. 8, Ln. 20-21).
Regarding Claim 5, Kaplan discloses the one or more fluid delivery ports are adapted releasing a fluid delivered to the tube via an associated one of the plurality of first lumens (see Fig. 4).
Regarding Claims 6, 17, Kaplan discloses the delivery ports correspond to a barrel portion of the inflatable balloon (Fig. 1). However, Kaplan fails to disclose that this barrel portion is “cylindrical”, rather Kaplan illustrates an oblate spheroid shape. However, related catheter balloons (see Fig. 11 – El-Nounou) are known to comprise shapes which comprise a cylindrical barrel section between the two tapered end sections (see Fig. 11, 12). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the balloon of Kaplan to comprise a cylindrical barrel section instead of an oblate spheroid, as disclosed by El-Nounou, to provide a constant diameter in the working length of the balloon ensuring the application of equal pressure to vascular wall about the entirety of the working length.
Regarding Claim 7, Kaplan discloses each tube includes a closed end (33) adjacent a distal end of the shaft (see Fig. 4E).
Regarding Claims 8 and 18, Kaplan discloses each tube is bonded to an outer surface of the inflatable balloon (see Fig. 4C).
Regarding Claims 9, 19, and 22, Kaplan discloses adjacent tubes are spaced apart in a circumferential direction along an outer surface of the inflatable balloon (see Fig. 4B, 4C).
Regarding Claims 10 and 23, Kaplan discloses the plurality of tubes are closer to each other in a deflated condition of the inflatable balloon (see Fig. 4A) than in an inflated condition of the inflatable balloon (Fig. 4B).
Regarding Claim 20, Kaplan, as modified, discloses an open proximal end of each tube is located within the distal end portion of the shaft (see modifications in view of El-Nounou to terminate the tubes within the annular manifold at the distal end of the shaft) and in communication with the at least one first lumen in the proximal end portion of the shaft (see modifications in view of El-Nounou – Fig. 1 and 3).
Claim(s) 3 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 5,336,178 (“Kaplan”) in view of U.S. Publication No. 2007/0250035 (“El-Nounou”) as applied above, and further in view of U.S. Publication No. 2001/0039411 (“Johansson”).
Regarding Claim 3, 15, Kaplan discloses each tube has a diameter (RE: 0.1-0.2mm), but fails to disclose the express diameter of the central lumen (70, 78). However, the instant illustrations appear to present the central inflation lumen to be of a diameter larger than that of the ancillary tubes (see Fig. 4E). Furthermore, it is known in the art of vascular balloon catheters than the inflation lumens can have inner diameters from about 0.2 to 0.4mm (Par. 128). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the central inflation lumen of the invention of Kaplan to be between 0.2mm and 0.4mm (a value which exceeds that of the tube diameter), as disclosed by Johansson, in order to provide a suitably dimensioned inflation lumen to ensure a sufficient volume of fluid can be provided to inflate the balloon at suitable pressures and flow rates. It has been held that change in size/proportion are obvious and require only routine and customary skill in the art, see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955), and In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, while El-Nounou was previously applied, it was not applied with respect to the features presented in amended Claim 1 and El-Nounou teaching these features was not addressed by Applicant.
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 WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 03/04/2026