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, drawn to a cannula for de-airing of a patient’s heart, and Catheter Species A1 (Figs 1-30), Fixer Species B5 (Figs 39-40), Balloon Species C2 (Figs 41-46), Wrap Species D2 (Fig 47), and Balloon Catheter Species E3 (Figs 60-69), readable on claims 1-4, 7-11, 13, 15, and 17, in the reply filed on April 13, 2026 is acknowledged. It is noted Applicant listed claim 13 as readable on the elected species. However, claim 13 depends on withdrawn claim 12 and thus claim 13 is additionally being withdrawn from consideration.
Claims 5-6, 12-14, 16, and 18-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 13, 2026.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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, 7, 15, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Houser (US 2012/0197378, hereinafter “Houser”).
Regarding claim 1, Houser discloses the invention substantially as claimed including a balloon catheter (Figs 82a, 82g; para [0142]) comprising a catheter (1650) having longitudinally opposite proximal and distal catheter end portions, the catheter having a catheter inflation opening;
an expandable balloon (810, 820) positioned on at least the distal catheter end portion, the balloon defining at least one balloon opening (opening 815 between balloon halves 820);
a second balloon catheter lumen (830) extending substantially longitudinally from the proximal catheter end portion to at least the at least one balloon opening (815); and
an inflation lumen (825) extending substantially longitudinally from the proximal catheter end portion to the catheter inflation opening, the catheter inflation opening providing fluid communication between the inflation lumen and an inflatable volume of the expandable balloon (para [0142]).
However, in the embodiment of Figs 82a and 82g, Houser discloses only two lumens and fails to disclose the claimed first balloon catheter lumen extending substantially longitudinally from the proximal catheter end portion toward the distal catheter end portion. In an alternative embodiment (Figs 93a-f; para [0168]), Houser discloses a balloon catheter (Fig 93a) comprising three distinct lumens: a peelable guidewire lumen (1210) – similar to the second balloon catheter lumen (830) of the embodiment of Fig 82g, an inflation lumen (825), and further comprising an additional guide wire lumen (830) along the central axis extending substantially longitudinally from the proximal catheter end portion toward the distal catheter end portion. 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 the embodiment of Figs 82a and 82g of Houser to further include an additional balloon catheter lumen extending substantially longitudinally from the proximal catheter end portion toward the distal catheter end portion to provide a central guide wire lumen and provide the physician additional control over the delivery of the balloon catheter.
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Regarding claim 7, wherein the at least one balloon opening (815) of the balloon includes a plurality of balloon openings (diametrically opposite openings between balloon halves), the second balloon catheter lumen extending through each of the balloon openings (para [0142]).
Regarding claim 15, wherein the balloon includes inner and outer balloon portions, the inner balloon portion being fixed to at least the catheter such that only the outer balloon portion moves during inflation of the balloon, the inflatable volume of the balloon being between the inner and outer balloon portions (Figs 82a, 82g).
[AltContent: arrow][AltContent: arrow][AltContent: textbox (Inner balloon portion)][AltContent: textbox (Outer balloon portion)]
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Regarding claim 17, wherein the balloon (820) includes first and second balloon end portions a portion of the first balloon end portion being attached to at least a portion the second balloon end portion in such a manner that the at least balloon (815) opening is defined between the first and second balloon end portions.
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Claim(s) 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Houser (US 2012/0197378), as applied to claim 1 above, further in view of Johnson et al. (US 2013/0041316, hereinafter “Johnson”).
Regarding claim 8, Houser discloses the invention substantially as claimed including the balloon (820) having a balloon opening (815) (Figs 82a, g; para [0142]). However, Houser fails to disclose the balloon has a plurality of thin material portions surrounding the at least one balloon opening. Johnson discloses a similar balloon catheter having a balloon (34) with a balloon opening for a guidewire (40) channel (30) and teaches the balloon further comprises a thin material (32) surrounding the at least one balloon opening (Figs 1-2; para [0071, 0074-0075]), wherein the thin material may be interpreted as comprising a plurality of portions, for example proximal and distal portions. 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 Houser to further include a thin material surrounding the balloon opening (815), as taught by Johnson, to further aid in defining the guide wire channel during delivery of the balloon catheter.
Regarding claims 9-10, Houser discloses the invention substantially as claimed including the balloon (820) having a balloon opening (815) and a second balloon catheter lumen (830) extending from the proximal catheter tip to the balloon opening (Figs 82a, g; para [0142]). However, Houser fails to disclose a wrap encapsulating the balloon, the wrap having at least one wrap opening extending radially therethrough, the at least one wrap opening being aligned with the at least one balloon opening, the second balloon catheter lumen extending from the proximal catheter tip to the at least one wrap opening. Johnson discloses a similar balloon catheter having a balloon (34) with a balloon opening for a guidewire (40) channel (30) and teaches the balloon further comprises at least one wrap (32) encapsulating the balloon, the wrap having at least one wrap opening (perforations, for example) extending radially therethrough and aligned with the at least one balloon opening, wherein a plurality of thin material portions surround the at least one balloon opening (thinned material of perforations adjacent openings of perforations) (Figs 1-2; para [0071, 0074-0075]). The wrap (32) is larger than the balloon opening (30) such that the thin material portions break and extend through the at least one wrap opening when the balloon is inflated (perforations separate and open when balloon is inflated – para [0074]). 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 Houser to further include a wrap encapsulating the balloon and thin material portions, the wrap having at least one wrap opening extending radially therethrough and thin materials portions, the at least one wrap opening being aligned with the at least one balloon opening, the second balloon catheter lumen (guidewire channel) extending from the proximal catheter tip to the at least one wrap opening, as taught by Johnson, to further aid in defining the guide wire channel during delivery of the balloon catheter.
Regarding claim 11, Houser teaches “the catheter or the various parts of the catheter can be coated (static or active eluding) to be lubricious, anti-thrombogenic, therapeutic, or any combination of these or other suitable coating types, materials, and objectives” (para [0135]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the combination would further comprise a therapeutic substance that is held between the wrap and the balloon, embedded in the wall of the wrap, or embedded in an outer surface of the balloon, inflation of the balloon causing delivery of the therapeutic substance to a target site directly or through a plurality of perforations in the wrap, as taught by Houser to assist with treating the target area of the body.
Allowable Subject Matter
Claims 2-4 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art fails to teach and/or disclose the combination of the claimed open catheter slit and fixer, particularly wherein the fixer has longitudinally opposite proximal and distal fixer tips and at least one fixer sidewall opening spaced longitudinally from each of the proximal and distal fixer tips, the fixer being disposed within the catheter such that the fixer is at least partially surrounded by the inner catheter surface and the at least one fixer sidewall opening is aligned with both the open catheter slit and the at least one balloon opening, the second balloon catheter lumen extending through the at least one fixer side wall opening.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771
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