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 Amendment
This office action is responsive to the amendment filed on December 19, 2025. As directed by the amendment: claims 1-2, 4-5 and 9-13 have been amended, claim 16 has been cancelled, and claims 17-21 have been added. Thus, claims 1-15 and 17-21 are presently pending in this application, with claims 14-15 withdrawn. Applicant’s amendments are sufficient to overcome the claim objections and §112(b) rejections of the previous action.
For future amendments, please see MPEP 714(II)(C) that requires newly amended independent claim 5 to include underlines for subject matter incorporated from claim 1.
Response to Arguments
Applicant's arguments filed December 19, 2025 have been fully considered but they are not persuasive.
On page 4 of the Remarks, Applicant argues that Chen does not teach the balloon including through openings defined by the sleeve structure. In response, Examiner notes that claim 1 lines 8-10 recite the claimed structure at issue regarding planar sections and/or struts which delimit (define the limits) through-openings (annotated Fig. 8B shows planar sections encompassing and thereby defining the limits of the through-openings) so that the functional sleeve delimits balloon expansion in sections (sections are the portion of the functional sleeve corresponding to the through-openings), and wherein Chen teaches the claimed structure as most clearly shown in annotated Fig. 8B, see rejection below.
On page 4 of the Remarks, Applicant argues the rationale for the modification of Chen with Brohm-Schmitz-Rode (Brohm) is not grounded in the references. In response, Examiner notes that the rationale for minimizing the outer diameter is provided by Brohm P0038, which allows for treating more narrow vessels as noted the rejection below.
On pages 4-5 of the Remarks, Applicant further argues the modification. In response, Examiner notes that Brohm teaches a folding technique well known in the art and is analogous art in that Brohm teaches folding a balloon having a sleeve. Brohm is only applied to modify the folding of Chen for purpose of minimizing the outer diameter of the device to improve delivery through blood vessels.
On page 5 of the Remarks, Applicant argues the combination is based on hindsight. Examiner points to MPEP 2141.01(III) that describes that content of the prior art is determined at the relevant time to avoid hindsight.
Claim Objections
Claim 5 is objected to because of the following informalities: please delete “in particular” from line 13. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 lines 7-8 recite “…wherein additionally and alternatively…”. It is not clear if “additionally” is another way that connection of the sleeve to the balloon is made that is an alternative to those previously recited, or if it is an alternative that builds upon previously recited ways of connection.
Claim 19 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 19 is a product claim (balloon catheter device) which claims both an apparatus and the method steps of using the apparatus, and is therefore indefinite per MPEP 2173.05(p)(II). For purposes of examination, the method steps are interpreted functionally, wherein line 3 is interpreted as “…axial direction, and is configured to be folded together with, and unfolded together with, the balloon such…”.
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.
Claims 1-4, 12-13 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (Chen) US 2009/0227948 A1 in view of Brohm-Schmitz-Rode US 2019/0231565 A1.
Regarding claim 1, Chen discloses a balloon catheter device for atraumatic dilation of hollow organs (Fig. 8A-B), comprising a balloon catheter (elongate shaft 202, P0042) with a balloon (balloon 204, P0042), a tubular functional sleeve (sheath 206, P0042) applied to the balloon for directional segmented cushion-like unfolding of the balloon (the sheath is fully capable of directional segmented cushion-like unfolding of the balloon, see Fig. 8B), and wherein the functional sleeve is unfoldable in a final state for abutting against an inner wall of a hollow organ (the sheath is fully capable of being unfolded in a final state against an inner wall of a hollow organ because it is positioned on the exterior of the balloon), and wherein the tubular functional sleeve has planar sections (planar sections, see annotated Fig. 8B below) and/or planar struts which delimit through-openings (through-openings, see annotated Fig. 8B below), so that the functional sleeve delimits balloon expansion in sections (sections are the portion of the functional sleeve corresponding to the through-openings), wherein the functional sleeve is connected to the balloon in the region of the planar sections and/or the planar struts (the sheath may be attached to the surface of the balloon at one or more points or continuously, P0026).
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Chen does not explicitly teach wherein the functional sleeve is folded in an initial state together with the balloon about a sleeve longitudinal axis, and wherein the folding of the functional sleeve is directed as pleating about a sleeve longitudinal axis.
However, Brohm-Schmitz-Rode teaches a tubular sleeve and system for the atraumatic treatment of hollow organs wherein the functional sleeve (sleeve 1, P0112) is folded in an initial state (Fig. 1) together with the balloon (Fig. 3) about a sleeve longitudinal axis (P0108), and wherein the folding of the functional sleeve is directed as pleating about a sleeve longitudinal axis (P0112).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to fold the balloon catheter of Chen as taught by Brohm-Schmitz-Rode for the purpose of minimizing the outer diameter of the device Brohm-Schmitz-Rode P0038, to treat narrow vessels positioned distally in the vasculature relative to the insertion site.
Regarding claim 2, Chen in view of Brohm-Schmitz-Rode teaches the balloon catheter device according to claim 1, wherein the functional sleeve is formed from a polymer (Chen, polymer material, P0026) with a low stretchability, the stretchability of which is lower than the stretchability of the balloon (Chen, expansion of the sheath causes tearing of the sheath along perforation lines208 to form tears 209, P0043, illustrating a lower stretchability of the sheath relative to the balloon which does not tear).
Regarding claim 3, Chen in view of Brohm-Schmitz-Rode teaches the balloon catheter device according to claim 1, wherein the sleeve has a diameter that corresponds approximately to the diameter of the expanded balloon (Chen, Figs. 8A-8B).
Regarding claim 4, Chen in view of Brohm-Schmitz-Rode teaches the balloon catheter device according to claim 1, wherein the connection of the sleeve to the balloon is made: by punctiform polymer welding or gluing, the connection points lying on inner folding lines, or by planar adhesion of an active substance-containing adhesive gel between the balloon and the functional sleeve, wherein the connection between balloon and sleeve is made by adhesion of an active substance-containing adhesive layer arranged between the balloon and the functional sleeve, wherein additionally and alternatively a punctiform and/or linear connection by laser welding, or a planar connection by adhesive bonding, including a connection over all planar surfaces or struts, is provided (this is being interpreted as product by process claim limitation, see MPEP 2113, wherein determination of patentability is based on the product itself and does not depend on its method of production, wherein if the product in the product-by-process claim (sleeve connected to the balloon) is the same as or obvious from a product of the prior art (Chen, spot welding of the sheath to the balloon, P0041), the claim is unpatentable even though the prior product was made by a different process).
Regarding claim 12, Chen in view of Brohm-Schmitz-Rode teaches the balloon catheter device according to claim 1, wherein the entire functional sleeve and thus the planar struts forming the functional sleeve have pores (Chen, sheath may be made of permeable or semi-permeable material to allow the passage of the therapeutic agent through the sheath, P0026), so that the functional sleeve allows active substance release over its entire circumferential wall (the functional sleeve is fully capable of allowing active substance release over its entire circumferential wall because the entire sleeve may be made of permeable or semi-permeable material, P0026).
Regarding claim 13, Chen in view of Brohm-Schmitz-Rode teaches the balloon catheter device according to claim 1, wherein the sleeve is unfoldable and foldable together with the balloon (the sleeve is fully capable of being unfolded and folded together with the balloon because they are attached).
Regarding claim 17, Chen in view of Brohm-Schmitz-Rode teaches the balloon catheter device of claim 1, wherein the through-openings are preformed as slits (Chen, slits, P0041) and/or windows, and wherein, in the region of the planar sections and/or planar struts, the functional sleeve is configured to enable the balloon to be expanded in a limited manner by exerting a circumferential limiting effect on an expanding balloon (Chen, in the region of the planar sections and/or planar struts, the functional sleeve is fully capable of enabling the balloon to be expanded in a limited manner by exerting a circumferential limiting effect on an expanding balloon, P0045 and Fig. 8B) and wherein the functional sleeve is non-slidably connected to the balloon in the region of the planar sections and/or planar struts (Chen, spot welding of the sheath to the balloon, P0041).
Regarding claim 18, Chen in view of Brohm-Schmitz-Rode teaches the balloon catheter device of claim 1, wherein the functional sleeve is secured against slipping on the balloon (Chen, Fig. 8A showing the conical ends of the sleeve).
Regarding claim 19, Chen in view of Brohm-Schmitz-Rode teaches the balloon catheter device of claim 18, wherein the functional sleeve is connected to the balloon essentially over an entire length of the functional sleeve in an axial direction (Chen, Fig. 8A) and is folded together with, and unfolded together with, the balloon such that the functional sleeve remains on the balloon and is removed from the hollow organ together with the balloon (the functional sleeve is fully capable of being folded together with, and unfolded together with, the balloon such that the functional sleeve remains on the balloon and is removed from the hollow organ together with the balloon).
Regarding claim 20, Chen in view of Brohm-Schmitz-Rode teaches the balloon catheter device of claim 18, wherein the functional sleeve includes a proximal conical section and a distal conical section having a smaller cross-section than the rest of the functional sleeve (Chen, see annotated Fig. 8A below), the conical sections being designed to prevent axial displacement of the functional sleeve on the balloon (the conical sections are fully capable of preventing axial displacement of the functional sleeve on the balloon).
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Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Brohm-Schmitz-Rode in view of Hunter et al. (Hunter) US 2005/0149175 A1.
Regarding claim 10, Chen in view of Brohm-Schmitz-Rode teaches the balloon catheter device according to claim 1, wherein a medical active substance layer (Chen, therapeutic agent 18, P0042) containing a medical active substance (Chen, P0066) is arranged between the functional sleeve and the balloon (Fig. 8B), wherein the medical active substance layer is formed as a coating of the balloon formed from a gel (Chen, gel, P0057) and a medical active substance, so that the medical active substance is contained in a gel formulation.
Chen does not teach the gel to be a biodegradable polymer gel.
However, Hunter teaches intravascular devices wherein the gel is a biodegradable polymer gel, P0121.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the gel of Chen to be a biodegradable polymer gel for the purpose of maintaining the gel in place over time to improve delivery of the therapeutic agent as well as eventually clearing it from the patient’s body.
Regarding claim 11, Chen in view of Brohm-Schmitz-Rode in view of Hunter teaches the balloon catheter device according to claim 10, wherein the medical active ingredient is incorporated in a polymer of the medical active ingredient layer (polymer gel, see above claim 10), and wherein the active medical ingredient is: an antiproliferative, including sirolimus, other limus derivatives, or paclitaxel (PTX): (Chen, paclitaxel, P0066).
Allowable Subject Matter
Claims 5-9 and 21 are allowed.
Reasons for Allowance
The following is an Examiner's statement of reasons for allowance: the claims in this application are allowed because the prior art of record fails to disclose either singularly or in combination the claimed balloon catheter .
The closest prior art is Chen et al. (Chen), US 2009/0227948 A1.
Regarding claim 5, Chen fails to teach among all the limitations or render obvious a balloon catheter as claimed, which includes wherein sections with axial slits, which are referred to as axial sections, and sections with tangential slits, which are referred to as tangential sections, are formed alternately in the functional sleeve in an axial direction of the functional sleeve, and wherein the axial sections and the tangential sections are arranged spaced from each another, in combination with the total structure and function of the balloon catheter as claimed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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.
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/J.A.D./Examiner, Art Unit 3783
/James D Ponton/Primary Examiner, Art Unit 3783