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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01 June 2026 has been entered.
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, 5, 7-10, 12, 13, 14, 16, and 18-23 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. Patent No. 5,704,913 (“Abele”) and U.S. Publication No. 2007/0239110 (“Shah”).
Regarding Claim(s) 1, 7, 8, 12, 13, 16, 18, and 21, Kaplan discloses a medical device (Fig. 1), comprising:
A shaft (20) having a proximal end (see generally Fig. 1C) and a distal end (see Fig. 4E), the shaft including a plurality of first lumens (see the interior of 32);
An inflatable balloon (84) including a proximal tapered end (see Fig. 1E), 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), the annular lumen being defined between an outer tubular portion of the shaft (38) and a coaxially inner shaft (see Fug, 1C, 1D) extending within the outer tubular portion.
Kaplan discloses the invention substantially as claimed except that the annular lumen extends proximal of the proximal end of each of the plurality of first lumens. Rather, Kaplan locates the annular lumen (re: “manifold” – 58) in the proximal end of the shaft with independent lumens (62) serving to adjoin the annular lumen/manifold with the proximal end of the plurality of first lumens (see Fig. 4E). However, Abele discloses a related medical device/catheter (10) which like that of Kaplan comprises a catheter shaft (26) having a balloon (12) formed thereon, the balloon comprising a plurality of first lumens/channels (32) disposed thereabout wherein the lumens can be fluidly connected to the catheter shaft and proximal end in a variety of manners (see Fig. 5 and 6). Among these connection configurations Abele discloses one (Fig. 6) similar to that of Kaplan wherein lumens/channels (32, 52) are in communication with a separate lumen (46/34 and 50/48) and an alternative configuration wherein the lumens/channel (32) are in communication with a common annular lumen/manifold (46) being defined between an outer tubular portion (28) of the shaft and a inner shaft (26b) extending within the outer tubular portion, the annular lumen extending proximal of the proximal end of each of the plurality of first lumens (see Fig. 5). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the catheter of Kaplan such that joint fluid communication is provided to the first lumens via an annular lumen defined between an outer tubular portion of the shaft and an inner shaft extending within the outer tubular portion with the annular lumen extending proximal of the proximal end of each of the plurality of first lumens, as disclosed by Abele, as Abele discloses the claimed arrangement of a common, proximally located annular lumen to be a suitable, recognized alternative to independent proximal lumens such as those disclosed by Kaplan and whereby it has been held that substitution of suitable equivalents requires only routine and customary skill in the art and is an obvious design choice when it affects only expected and predictable results, see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, such a modification amounts to essentially relocating the existing manifold (58) to a location/shape at the distal end (as opposed to the proximal end) constitutes a mere rearrangement of the location of the working parts of an invention is similarly obvious when such a rearrangement is predictable and confers only expected results, see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
In the instant case Abele fails to illustrate the annular lumen (46) as defined by the outer tubular portion (28) and inner shaft (26b) to be “coaxial”. Rather the two lumen are shown as being offset in a side-by-side arrangement (see Fig. 5). However, it is noted that the manifold/annular lumen (58) of Kaplan is illustrated as coaxial with the inner shaft see Fig. 1C and 1D). Likewise, Shah discloses a related balloon catheter (10) wherein an equivalent lumen (16) and inner shaft (14) can be provided in either a coaxial, concentric configuration (see Fig. 3) or a side-by-side arrangement (see Fig. 5A or 5B) with equivalent function as clear alternatives to one another affecting only predictable and expected results. As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the annular lumen of modified Kaplan to be coaxial and concentric with the inner shaft such that the outer tubular portion of the shaft and the inner shaft are coaxial and concentric in their extension continuously from a proximal end hub of the catheter shaft to the proximal end of the first lumens, as disclosed by Shah, wherein the prior art demonstrates the two arrangements to be an obvious design choice affecting only expected and predictable results as a mere product of simple substitution of known equivalents.
PNG
media_image1.png
188
333
media_image1.png
Greyscale
PNG
media_image2.png
155
173
media_image2.png
Greyscale
PNG
media_image3.png
395
779
media_image3.png
Greyscale
Supplemental Figures: Kaplan modified to construct a coaxial manifold/annular lumen which extends from the proximal end of the catheter shaft to the distal end of the catheter shaft such that the annular lumen extends proximally of the proximal end of each of the plurality of first lumens
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 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 and in communication with the at least one first lumen in the proximal end portion of the shaft (see Fig. 4E).
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. Patent No. 5,704,913 (“Abele”) and U.S. Publication No. 2007/0239110 (“Shah”) as applied above, and further in view of U.S. Publication No. 2001/0039411 (“Johansson”).
Regarding Claim 3 and 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).
Claim(s) 6 and 17 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. Patent No. 5,704,913 (“Abele”) and U.S. Publication No. 2007/0239110 (“Shah”) as applied above, and further in view of U.S. Publication No. 2007/0250035 (“El-Nounou”).
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.
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.
Conclusion
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).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 08/25/2026
Prosecution Insights