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 Arguments
The amendments to the claims have overcome the previously presented 35 USC 112b rejections.
Applicant's arguments filed 1/15/2026 with respect to the amendments to claim 1 overcoming the previously presented 35 USC 102a1 rejections over the prior art of Kelley have been fully considered but they are not persuasive. Applicant notes that the Kelley expressly discloses using the balloon catheter to incise atherosclerotic plaque in blood vessels and fails to expressly disclose using the balloon for linear segmentation of glandular tissue. However, the claims are drawn to an apparatus, not its method of use. Therefore, the prior art device must only be capable of being used for linear segmentation of glandular tissue in order to meet this recitation of intended use in the apparatus claims. Because the prior art balloon catheter of Kelley meets all of the structural limitations of claim 1 as discussed in more detail below and is capable of being inflated next to glandular tissue and used for linear segmentation of the glandular tissue (via inflation of balloon to put blade 20 into contact with glandular tissue), it meets this recitation of intended use.
Applicant also asserts that Kelley fails to disclose an elastic connector as claimed. This is not found persuasive. The elastic connector of Kelley comprises a gasket (polyurethane pad 18), two elastic tendons (22,24) and two sleeve rings (adhesive 18 around 30,36; which forms a sleeve in view of shading in fig. 5; see also [0044]), the gasket is fixed on a surface of the dilated straight working segment ([0035], [0036]), the two sleeve rings (fig. 3: 18 covering 30 and 36) are fixedly sleeved on the corresponding thin-neck straight segments respectively, one of the elastic tendons is connected between an end of the gasket and one of the sleeve rings, and the other one of the elastic tendons is connected between the other end of the gasket and the other one of the sleeve rings (fig. 3). The elastic connector is made of plastic with viscoelasticity (portion 18 is polyurethane as per [0036] of Kelley; note specification of instant application lists polyurethane as a viscoelastic plastic: see [0038] of instant application as filed 6/12/2024). The two elastic tendons are separated from the corresponding transition segments (see [0042]) so that the elastic connector is in an active state, noting that the specification of the instant application describes the “active state” as the state in which the elastic tendons are separated from the corresponding transition segments ([0036] of spec. as filed 6/12/2024) Because the elastic tendons (22,24; fig. 1) of Kelley are separated from the transition segments (42, 44) of the balloon body (see par. [0042]: elastic tendons are not adhesively or otherwise engaged to the balloon surface), they can freely expand and contract without being restricted by the transition segments in the same manner as the instant invention. Thus, the rejections over Kelley, and Kelley in view of Weber, are maintained but have been updated to reflect the amendments to the claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2 and 5-7 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Kelley (US 2006/0111736). Kelley discloses a balloon catheter (60), wherein the balloon catheter comprises a balloon body (10), an elastic connector (30,22,32,18,34,24,36; see fig. 1; can by nitinol, which is elastic) and a linear segmentation part (20), wherein: a middle portion (18) of the elastic connector is fixed on a surface of the balloon body ([0035]-[0036]), the linear segmentation part is provided in the middle portion of the elastic connector (see fig. 1), two ends (30,36) of the elastic connector are fixedly connected with two ends of the balloon body respectively ([0044]), and a position (e.g., at 22 or 24) between the middle portion (18) of the elastic connector and an end portion of the elastic connector is separated from the balloon body ([0042]).
The balloon body comprises a dilated straight working segment (40), two transition segments (42,44; fig. 1) and two thin-neck straight segments (46, 48), the two transition segments are respectively located on two sides of the extended straight working segment, one end of each of the two transition segments are connected with two ends of the dilated straight working segment respectively, and the other end of each of the two transition segments are connected with a corresponding one of the two thin-neck straight segments respectively; and a diameter of the dilated straight working segment is greater than a diameter of the thin-neck straight segments, and a diameter of the transition segments gradually decreases in a direction from the dilated straight working segment to the thin-neck straight segments (see fig. 1).
The elastic connector comprises a gasket (polyurethane pad 18), two elastic tendons (22,24) and two sleeve rings (adhesive 18 around 30,36; which forms a sleeve in view of shading in fig. 5; see also [0044]), the gasket is fixed on a surface of the dilated straight working segment ([0035], [0036]), the two sleeve rings (fig. 3: 18 covering 30 and 36) are fixedly sleeved on the corresponding thin-neck straight segments respectively, one of the elastic tendons is connected between an end of the gasket and one of the sleeve rings, and the other one of the elastic tendons is connected between the other end of the gasket and the other one of the sleeve rings (fig. 3). The elastic connector is made of plastic with viscoelasticity (portion 18 is polyurethane as per [0036] of Kelley; note specification of instant application lists polyurethane as a viscoelastic plastic: see [0038] of instant application as filed 6/12/2024).The two elastic tendons are separated from the corresponding transition segments (see [0042]: elastic tendons are not adhesively or otherwise engaged to the balloon surface) so that the elastic connector is in an active state, noting that the specification of the instant application describes the active state as the state in which the elastic tendons are separated from the transition segments. Because the elastic tendons of Kelley are separated from the transition segments, they can freely expand and contract without being restricted by the transition segments.
The limitation “for linear segmentation of gland tissue” is a recitation of intended use. Since the claims are drawn to an apparatus and not its method of use, the prior art need only be capable of being used in the claimed manner in order to meet this limitation. Because the balloon catheter of Kelley is capable of being inflated next to gland tissue in order to segment the tissue via linear segmentation part (20), it meets this recitation of intended use.
Regarding claim 2, a length of the elastic connector in an axial direction of the balloon body (consider length of portion 22 of elastic connector, or length of middle portion 18 of the elastic connector, noting claim does not specify what length of the elastic connector is being recited) is less than an axial length of the balloon body under a contraction state of the balloon body (e.g., consider length of entire balloon body).
Regarding claim 5, the gasket (18) has a long-strip shaped structure and extends along an axial direction of the balloon body, and a length of the gasket is less than an axial length of the dilated straight working segment (noting in fig. 1 that 18 is shorter than length of segment 40).
Regarding claim 6, the linear segmentation part (20) has a long-strip shaped structure as understood in view of figs 1-5, a length of the linear segmentation part is less than a length of the gasket (18) (see examiner-annotated fig. 1 below), the linear segmentation part is fixed in a middle position of a surface of the gasket (figs. 4, 5), and the linear segmentation part extends along a length direction of the gasket.
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Regarding claim 7, a cross section of the linear segmentation part is a polygon (see fig. 2- triangle).
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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelley. Kelley discloses the invention as claimed except for the claimed dimensions of the linear segmentation part. However, it would have been obvious to one of ordinary skill in the art to have modified the prior art of Kelley to dimension the linear segmentation part to have a distance of 0.5mm to 5mm from top to bottom of a cross section, and a width of a bottom of the cross section to be less than 5 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984, cert. denied, 468 U.S. 830, 225,SPQ 232 (1984). In the instant case, both the linear segmentation part of the claimed invention (having the claimed dimensions) and the linear segmentation part of Kelley are meant to incise tissue against which they are pushed and thus a device having the claimed dimensions would not perform differently than the prior art of Kelley. It is further noted that no criticality is disclosed for the claimed dimensions in the instant application as originally filed.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kelley in view of Weber (US 2004/0133223). Kelley discloses the invention substantially as stated above including that the balloon or linear segmentation part may be used to deliver a drug ([0052]), but does not expressly disclose that a surface of the balloon body and/or a surface of the linear segmentation part is/are coated with a drug layer. Weber discloses another balloon catheter (fig. 1) having a balloon (24) with linear segmentation parts (26) meant to incise tissue. Weber discloses that the balloon may be coated with a sponge coating loaded with drugs such that the drug is released during expansion of the balloon ([0042]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Kelley to coat the surface of the balloon body with a drug layer (sponge coating loaded with a drug as per Weber) in view of Weber for the predictable result of providing a known means of delivering a drug to surrounding tissue via a balloon on a balloon catheter.
Conclusion
THIS ACTION IS MADE FINAL. 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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KSH 2/26/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771