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 102a1 rejections over Trotta and over Green. In view of the amendment to claim 1 now requiring that the inner tube is provided with an electrode, and that the balloon wall is made of nitrogenous polymers, polyesters, and epoxy resins, and the insulating layer is made of one or more of rubbers, fibers, and inorganic materials, the prior art of Hakala, Ciamacco, Jr. and Wang have been added to the rejections as presented below. Note that the limitations added to claim 1 with respect to the materials of the balloon wall and the insulating material are different from those that were in now-cancelled claims 8 and 9. Regarding Applicant’s argument that Trotta does not disclose that the central layer (20) functions as an electrical barrier or insulating layer, the claims are drawn to an apparatus, not its method of use or method of manufacture. The central layer of Trotta as modified in view of Wang (see discussion below) comprises the claimed material and the claimed thickness. Thus, it is considered capable of functioning as an insulating layer in the same manner as the instant application’s insulating layer. Applicant also asserts that Trotta is not a “pulse balloon”. This is not found persuasive as Trotta, as modified in view of Hakala, Ciamacco, and Wang, meets all of the structural limitations in the claims and thus is considered a pulse balloon as it is defined in the claims. Additionally, the electrode of Trotta as modified by Hakala creates shockwaves received by the balloon, which are considered energy pulses.
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, 4, and 6 is/are rejected under 35 U.S.C. 103 as being obvious over Trotta (US 5,478,320) in view of Ciamacco, Jr. (US 6,099,499), Wang et al. (US 7,273,471) and Hakala (US 2014/0039513).
Trotta discloses a balloon comprising a balloon body and an inner tube (19; fig. 1), wherein the inner tube penetrates through the balloon body (fig. 1) and the balloon body comprises an insulating layer (20; fig. 3) and a balloon wall (e.g., 10), the insulting layer located at an interior of the balloon wall (fig. 3), the balloon wall (10) having a thickness of 10-30 microns (Trotta discloses 0.0001 to 0.001 inch = 2.54 to 25.4 microns, col. 4, ll. 55-63, and thus discloses values within the claimed range) and the insulating layer (20) has a thickness of 1-5 microns (0.0001 to 0.002 inch, which includes 0.0001 inch = 2.54 microns; col. 4, ll. 55-63). See also col. 5, ll. 34-40, wherein balloon wall (10) may have a thickness of 0.0004 inch (10.16 micron), and the insulating layer may have a thickness of 10% of the overall balloon thickness (noting layer 24 also has a thickness of 10.16 micron), e.g., about 2.2 microns.
Trotta discloses that the balloon wall (10) is made of a nitrogenous polymer (polyamide, specifically nylon 1; col. 5, ll. 44-54), but fails to disclose that the balloon wall is also made of polyesters and epoxy resins.
Ciamacco discloses another balloon catheter. Ciamacco teaches that the balloon wall may be made from polyesters, epoxy resins and nitrogenous polymers (see col. 9, ll. 7-25, wherein polyamide is a nitrogenous polymer, and noting “and a combination thereof” at the end of the paragraph). According to Ciamacco, such materials are suitable for the construction of the balloon of a balloon catheter because they are biocompatible, biostable and minimize irritation to the body passageway during treatment (col. 9, ll. 7-25). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Trotta to construct the balloon wall (10 of Trotta) of nitrogenous polymers, polyesters, and epoxy resins in view of Ciamacco’s teaching that this combination of materials is suitable for the construction of a balloon because it is biostable and biocompatible, and it has been to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 125 USPQ 416).
Trotta also fails to expressly disclose that the insulating layer (20) is made of one or more of rubbers, fibers and inorganic materials.
Wang discloses another balloon having a balloon wall (outer layer 33) and an inner layer (34). Wang discloses that the inner layer may comprise silicone rubber to facilitate deflation of the balloon (col. 6, ll. 17-26). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Trotta to construct the inner layer from a rubber in view of Wang’s teaching that such material is suitable for an inner layer of a balloon and facilitates deflation of the balloon. Additionally, it has been to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 125 USPQ 416).
Trotta as modified by Ciamacco and Wang discloses the claimed balloon substantially as stated above, including that the balloon may be used for angioplasty, but fails to expressly disclose an electrode on the inner tube.
Hakala discloses another balloon catheter, wherein the balloon (408) is used for angioplasty to open up lesions in the wall of an artery. Hakala discloses that the balloon catheter includes an electrode (any one of electrodes of electrode assembly 406) on the inner tube (402; see fig. 4) the extends through the balloon, the electrode used to generate shockwaves that propagate outward in order to controllably fracture a calcified lesion to help prevent sudden stress and injury to the vessel when it is dilated using a balloon ([0003]; [0037]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Trotta to include an electrode on the inner tube, the electrode configured to generate shockwaves as taught by Hakala, in order to prevent sudden stress and injury to the vessel when it is dilated using the balloon. The balloon of Trotta as modified in view of Hakala is considered a “pulse” balloon as it receives a pulse from the shockwave generated by the electrode.
Regarding the limitation “when the insulating layer is located inside the balloon wall, the balloon body is prepared by extrusion blow molding: the extrusion blow molding comprises: co-extruding the insulating layer and the balloon wall to obtain a complex tube for blow molding; the blow molding has process parameters as follows: the temperature is 100-250° C., the heating time is 10-150 s, and the pressure is 50-1000 psi” (emphasis added), it is noted that claim 1 is drawn to a product (“A pulse balloon comprises…”), not its method of production. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113. Because this product-by-process limitation does not appear to necessitate any additional structure in the final product beyond that which is already recited in lines 1-7 of claim 1, the prior art of Trotta as modified by Ciamacco, Wang, and Hakala is considered to meet the structure necessitated by the product-by-process limitations.
Regarding claim 4, the insulating layer (20) is located inside the balloon wall (10) (i.e., the insulting wall is located entirely within the volume interior to balloon wall 10). Alternatively, the balloon wall can be considered to comprise layers 10 and 24, with insulating layer (20) located inside i.e., embedded within, the balloon wall.
Regarding claim 6, the inner tube is located on the symmetry axis of the balloon body (as understood in view of fig. 1).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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, Elizabeth Houston can be reached on 571-272-7134. 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.
KSH 11/13/2025
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771