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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-14) in the reply filed on 7/14/2026 is acknowledged.
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) 1-7, 9, 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (US 6,756,094) in view of Eskaros et al (US 2008/0140173).
Regarding claim 1, Wang discloses a composite medical balloon, comprising: a base balloon 118 comprising first and second tapered portions (regions 134 in fig 4) and a barrel portion (center portion between two sections labelled 134) there between, a first neck portion (one of left or right portions labelled 138 in fig 4) adjacent the first tapered portion, and a second neck portion adjacent the second tapered portion (other of portions labelled 138 that is not the first neck portion); and an outer layer 126 overlying the base balloon (fig 4), the outer layer comprising a film including a wider portion for fully covering the barrel portion (fig 2), and narrower portions for covering the first and second tapered portions, the first neck portion and the second neck portion (fig 2)
While Wang substantially discloses the invention as claimed, it does not disclose the film having a single longitudinal seam.
Eskaros discloses a balloon catheter where it discloses a film having a single longitudinal seam 13 (¶33).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Wang such that the film has a single longitudinal seam as taught by Eskaros as it is a known, alternative means by which to form a film/outer layer around an internal balloon.
Regarding claim 2, further including a fiber layer 122 between the base balloon and the outer layer (Col.4 ll 16-23).
Regarding claim 3, wherein the first neck portion is formed as a narrow cylinder fashioned to attach to a catheter shaft (figs 4 and 8).
Regarding claim 4, wherein the film forming the outer layer comprises a balloon shaped cut-out having a first portion having a first width approximately the same as a diameter of the barrel portion of the base balloon (fig 4).
Regarding claim 5, wherein the balloon shaped cut- out comprises a second portion having a second width approximately the same as a diameter of the first tapered portion of the base balloon (fig 4).
Regarding claim 6, wherein the balloon shaped cut- out comprises a third portion having a second width approximately the same as a diameter of the second tapered portion of the base balloon (fig 4).
Regarding claim 7, wherein the single longitudinal seam comprises overlapping longitudinal edge portions of the film bonded together (see combination in clam 1 above and fig 8 of Eskaros).
Regarding claim 9, wherein the outer layer has a length less than a length of the base balloon (length of center cylindrical section is less than that of all of base balloon).
Regarding claim 12, Wang discloses a catheter including a composite medical balloon. See claim 1 above where Wang and Eskaros teach the composite medical balloon of claim 1.
Regarding claim 13, Wang discloses a composite medical balloon, comprising: a base balloon 118 comprising a first neck portion (one of left or right portions labelled 138 in fig 4) adjacent a first tapered portion (adjacent portion 134), the first tapered portion meeting a barrel portion (center portion between portions labelled 134), a second tapered portion (other of portion 134 that is not first tapered portion), the second tapered portion meeting a second neck portion (other of portion labelled 138 that is not first neck portion); and an outer layer 126 overlying the base balloon, the outer layer comprising a film including a wider portion for fully covering the barrel portion, narrower portions for covering the first and second tapered portions, the first neck portion and the second neck portion (fig 4).
While Wang substantially discloses the invention as claimed, it does not disclose the film having a longitudinal seam formed by a bond facing the base balloon.
Eskaros discloses a balloon catheter where it discloses a film having a single longitudinal seam 13 formed by a bond facing the base balloon (¶33).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Wang such that the film has a single longitudinal seam as taught by Eskaros as it is a known, alternative means by which to form a film/outer layer around an internal balloon.
Claim(s) 8 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (US 6,756,094) in view of Eskaros et al (US 2008/0140173) and Shah (US 5,469,863).
Regarding claims 8 and 14, while Wang in view of Eskaros substantially discloses the invention as claimed, it does not disclose the outer layer comprises an everted tube such that the single longitudinal seam faces an outer surface of the base balloon.
Shah discloses a device which has a balloon with a longitudinal seam 44 (figs 7 and 8). Shah also discloses in an alternative embodiment (fig 6) that the seam may be external or everted after forming (Col.11 ll 47-50).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Wang in view of Eskaros such that the outer layer comprises an everted tube such that the single longitudinal seam faces an outer surface of the base balloon as taught suggested by Shah to decrease the device surface area and prevent the seam from damaging tissues as the balloon is inserted and/or inflated.
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (US 6,756,094) in view of Eskaros et al (US 2008/0140173) and Pepper et al (US 2010/0243135).
Regarding claims 10 and 11, wherein the film covers a barrel portion of the base balloon (fig 4).
While Wang substantially discloses the invention as claimed, it does not disclose further including a different material covering one or both tapered end portions of the balloon, nor the different material comprises a spirally wrapped film.
Pepper discloses other methods of making a non-compliant medical balloon, which may include spirally wrapping a film around the tapered end portions (and barrel portion) of the balloon (¶78-¶80). This method allows for varying thickness, pitch and number of wraps to vary the properties of the balloon as desired (¶78-¶80).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Wang such that it includes a different material covering one or both tapered end portions of the balloon, the different material comprising a spirally wrapped film as taught by Pepper to convey non-compliant properties while also controlling other properties such as thickness and elasticity, as desired.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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