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 .
Response to Amendment
This Office action is in response to the applicant’s communication filed 02/24/2026.
Status of the claims:
Claims 1 – 15 and 17 are pending in the application.
Claims 1 and 6 are amended.
Claim Objections
The objection to claim 6 in the previous action dated 11/26/2025 have been withdrawn in light of the Applicant’s amendments filed 02/24/2026. Specifically, the objection to claim 6, regarding typographical error has been withdrawn as the appropriate corrections have been made.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
the generic placeholders are “securing structure” in claim 1, which is coupled to the functional language “configured to limit the expansion of the balloon”. Furthermore, there are no structural modifiers either preceding or following the generic placeholders. For the purpose of examination, the “securing structure” in claim 1 will be read as an annular shaped member, band, elastic ring(s), a coil spring, (which is the disclosed corresponding structure, as described in paragraph [0047] and [0058] of the instant specification), or an equivalent structure thereof (which is any structure that performs the identical function of the generic placeholder(s) specified in the claim in substantially the same way).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The rejections of claims 1 – 15 under U.S.C 35 103 with respect to Tsutsui in view of Bohn, Osborn, and Roberts, recited in the previous action dated 11/26/2025 have been withdrawn in light of the Applicant’s amendments filed 02/24/2026. Specifically, the rejection of claim 1, with respect to Tsutsui in view of Bohn, Osborn, and Roberts has been withdrawn because the claim no longer requires the securing structure to not be bonded to the balloon and thus the Examiner no longer needs to rely on Roberts to teach any limitation of Claim 1. It should be understood that, other than the removal of Roberts, the previous rejection of claims 1 – 15 has not changed.
Claims 1 – 15 are rejected under 35 U.S.C. 103 as being unpatentable over Tsutsui et al (US 2015/0174383 A1) (previously cited), and in view of Bohn et al (US 2021/0236314 A1) (previously cited), Osborn (US 5,409,495) (previously cited).
Regarding claim 1, Tsutsui discloses a catheter (catheter balloon 10) (abstract, paragraph [0036] and Fig. 1) comprising:
a shaft (outer tube 60 and tip part 40) to be inserted into a body (paragraph [0036] and Fig. 1);
a balloon (balloon 20) that is attached to the shaft on a distal end and is expandable by a fluid supplied from a proximal end of the shaft (paragraphs [0036] and Fig. 1A);
a securing structure (band part 30) (Examiner’s note: as discussed above, securing structure is being interpreted under 112(f) an elastic band. And the securing structure of Tsutsui is an elastic band, and therefore is considered equivalent to the claimed securing structure) that is wound around an outer periphery of an intermediate portion between a distal end portion and a proximal end portion of the balloon (paragraphs [0038] and [0040], and Figs. 1A, 2A – 6D), wherein the securing structure limits expansion of the balloon at the intermediate portion (paragraph [0039]);
wherein the balloon (balloon 20) is folded in a completely compressed state (paragraph [0040] and Fig. 3D) (Examiner’s note: as shown in Fig. 3, the balloon 10 is folded up when in the completely compressed state; furthermore, as stated in paragraph [0040] “spread of the shoulder parts 23 causes the balloon 20, which has been folded up”, which means that prior to the inflation and at the completely compressed state the balloon is folded up. Therefore, Tsutsui encompasses the limitation above);
wherein the securing structure (band part 30) is attached to the center portion (intermediate portion) of the folded balloon (Fig. 3D) (Examiner’s note: under BRI the preceding limitation does not require the band part 30 to be secured to a folded portion of the balloon, only that the band part 30 be secured to the balloon when the balloon is folded, which is shown in Fig. 3D. However, the Examiner further notes that paragraph [0042] states “The part of which the band part 30 is fixed to the balloon part 20 may be fixed to the front face of the balloon part 20, or as illustrated in FIG. 4, when the balloon part 20 is folded in a wing-like fashion (folded in a so-called umbrella shape), the part may be evenly-fixed to the front end or middle part of each wing”. Therefore, the band part 30 is secured to center portion of the balloon which is folded up).
However, Tsutsui is silent regarding (i) a covering member that covers an outer periphery of the securing structure, wherein the covering member is fixed to parts of an outer periphery of the catheter or the balloon that are closer to the distal end of the shaft and the proximal end of the shaft than the securing structure.
As to the above, Bohn teaches, a balloon catheter for use in a variety of different body passageways and body lumens (abstract and paragraph [0033]), wherein the catheter (catheter system 100) comprises a shaft (catheter 200), a balloon (balloon 400) attached to the shaft (paragraph [0036]), and a covering member (cover 500) covering the outer periphery of the balloon (balloon 400), wherein the covering member is fixed to parts of an outer periphery of the catheter or the balloon that are closer to the distal end of the shaft and the proximal end of the shaft than the securing structure (paragraphs [0055 – 0064] and Figs. 4 and 6). Bohn further teaches wherein the covering member (cover 500) conforms to the outer surface of the balloon (paragraph [0056]) and helps reduce overexpansion of the balloon which may protect and reduce trauma to the patient (paragraph [0059]).
Additionally, Osborn teaches, in the same field of endeavor, a catheter (catheter 20) comprising a balloon (balloon 22) on a distal end thereof and a securing structure (restraining bands 23; which equates to the securing structure / band 30 of Tsutsui) and a covering member (sleeve 24) that covers the securing structure and the balloon (col. 5 lines 5 – 20, col. 5 lines 46 – 65, and Fig. 2). Therefore, Osborn teaches it is known to have a covering member covering a securing structure that is positioned over a balloon.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the balloon catheter of Tsutsui to incorporate the cover 500 of Bohn, for the purpose of reducing the risks of overexpansion of the balloon which may protect and reduce trauma to the patient (paragraph [0059] – Bohn). Additionally, it should be understood that, based on the disclosure and Fig. 1 of Osborn, as discussed above, Osborn makes obvious having a balloon with a securing member having a covering member 500 of Bohn cover the band part 30 (i.e., the securing structure) of Tsutsui as claimed. Furthermore, the prior art makes obvious having the covering member (cover 500 – Bohn) be fixed to the catheter (outer tube 60 of Tsutsui) a location proximal to the balloon and at a location distal to the balloon (i.e., on the tip part 40) and wherein the outer periphery of the securing member (band 30 of Tsutsui) is not bonded to the inner periphery of the covering member (cover 500 of Bohn). Bohn teaches, in paragraph [0077] and shows in Fig. 6, wherein the cover member (cover 500) is attached to the catheter via an adhesive at both ends of the cover (thus not adhesively bonded to the balloon); therefore, because the modification is such that the cover 500 is secured to the catheter of Tsutsui, not the balloon, and because the cover 500 covers the entire balloon, and thus the securing structure (band 30 of Tsutsui), the modified device would encompass wherein the cover member (cover 500) of Bohn is not be bonded to the outer periphery of the balloon or the outer periphery of the securing structure (band 30 of Tsutsui) and is bonded to the catheter as claimed.
Regarding claim 2, as discussed above, the combination of Tsutsui, Bohn, and Osborn teaches the catheter of claim 1. Additionally, Tsutsui discloses wherein the securing structure (band part 30) is elastically deformable in response to the expansion of the balloon (paragraphs [0038 – 0039] and Figs. 1A-B).
Regarding claim 3, as discussed above, the combination of Tsutsui, Bohn, and Osborn teaches the catheter of claim 1. Additionally, Tsutsui discloses wherein a secured diameter (diameter when not expanded – shown in Fig. 1B/3A) of the securing structure (band part 30) is smaller than a maximum expansion diameter (diameter shown in Fig. 1B/3A) of the intermediate portion of the balloon (Fig. 1B/3A).
Regarding claim 4, as discussed above, the combination of Tsutsui, Bohn, and Osborn teaches the catheter of claim 1. Additionally, the combination teaches wherein the balloon (balloon 20 – Tsutsui) is expandable to the maximum expansion diameter (diameter shown in Fig. 1B – Tsutsui) from a folded state, in accordance with pressure of the fluid (paragraph [0040] – Tsutsui), the securing structure (band part 30) (diameter when not expanded – shown in Fig. 1B – Tsutsui ) is expandable beyond the secured diameter (Fig. 1A – Tsutsui), by being elastically deformed by the balloon expanding (paragraph [0040] and Fig. 1A – Tsutsui), and the covering member (cover 500 – Bohn) is expandable by being elastically deformed by the balloon or the securing structure expanding (paragraph [0059] – Osborn).
Regarding claim 5, as discussed above, the combination of Tsutsui, Bohn, and Osborn teaches the catheter of claim 1. Additionally, Tsutsui discloses wherein, in a state where pressure of the fluid is lower than a predetermined value, an expansion diameter of the securing structure is smaller than a maximum expansion diameter of the intermediate portion of the balloon (paragraph [0040]) (Examiner’s note: additionally, as shown in Figs. 1A the expansion diameter of the securing structure is smaller than the maximum expansion diameter of the intermediate portion of the balloon shown in Fig. 1B).
However, Tsutsui in view of Bohn and Osborn is silent regarding (i) wherein the expansion diameter of the securing structure is smaller than the maximum diameter of the intermediate portion by at least 20%.
As to the above, because Tsutsui discloses that the expansion diameter of the securing structure is smaller than the maximum expansion diameter of the intermediate portion of the balloon it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the expansion diameter be at least 20% smaller than the maximum expansion of the intermediate portion as claimed 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 relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the securing structure (band 30) of Tsutsui would not operate differently with the claimed relative diameter since the expansion diameter of the securing structure (band 30) of Tsutsui is intended to be measurably smaller than the maximum diameter of the intermediate portion in order to properly restrict the expansion of the intermediate portion. Therefore, the securing structure (band 30) of Tsutsui would function appropriately with the claimed relative diameter.
Regarding claims 6 and 7, as discussed above, the combination of Tsutsui, Bohn, and Osborn teaches the catheter of claim 1. Additionally, the combination teaches wherein the securing structure (band 30 – Tsutsui) is made up of polyurethane (paragraph [0039] – Tsutsui) (which has an elastic modulus of 0.00345 – 0.0758 GPa), wherein the covering member (cover 500 – Bohn) is made up of ePTFE (paragraph [0060] – Bohn) (which has an elastic modulus of 0.01 to 0.13 GPa), and wherein the balloon (balloon 20 – Tsutsui) is made up of nylon (paragraph [0038] – Tsutsui) (which has an elastic modulus of 1.6 to 2.7GPa) (Examiner’s note: the balloon has the highest elastic modulus out of all three as required by the claims). Furthermore, the combination teaches that the securing structure (band 30 – Tsutsui) is used to aid in the controlling of the expansion of the balloon (paragraph [0028] – Tsutsui) and the covering member (cover 500 – Bohn) is used to aid in the controlling of the expansion of the balloon (by preventing over expansion) (paragraph [0059] – Bohn), and the material properties of each structure is what gives each structure the ability to control the expansion of the balloon; therefore, the material (and thus the elastic modulus) of each component (i.e., the securing structure and the covering member) is a result effective variable such that the type of material, and the elastic modulus thereof, results in the desired amount of expansion restriction of the balloon at the locations desired. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the securing structure (band 30 – Tsutsui) and the covering member (cover 500 – Bohn) of Tsutsui in view of Bohn to have the claimed relative elastic modulus values, wherein the elastic modulus of the securing member is higher than the covering member, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 8, as discussed above, the combination of Tsutsui, Bohn, and Osborn teaches the catheter of claim 1. Additionally, Tsutsui discloses wherein the securing structure (band 30) is an annular member wound around the outer periphery of the intermediate portion (paragraph [0039] and Fig. 1A and 1B).
Regarding claim 9, as discussed above, it would have been obvious to modify the balloon catheter of Tsutsui to incorporate the covering member of Bohn and in view of Osborn. Additionally, the combination teaches wherein the covering member (cover 500 – Bohn) covers a part of an outer periphery of the balloon (balloon 20 – Tsutsui) around which the securing structure is not wound, as well as the outer periphery of the securing structure (band 30 – Tsutsui) (Examiner’s note: as stated in the rejection of claim 1, the prior art makes obvious wherein the cover 500 of Bohn is attached to the balloon catheter at locations distal to the distal end of the balloon and proximal to the proximal end of the balloon and covering the securing structure of Tsutsui; therefore the modified device would encompass the limitation above as the cover member covers the entire balloon).
Regarding claim 10, as discussed above, it would have been obvious to modify the balloon catheter of Tsutsui to incorporate the covering member of Bohn and in view of Osborn. Additionally, the combination teaches wherein the covering member covers part of an outer periphery of the shaft where the balloon is not attached, as well as the outer periphery of the securing structure and the part of the outer periphery of the balloon (Examiner’s note: as stated in the rejection of claim 1, the prior art makes obvious wherein the cover 500 of Bohn is attached to the balloon catheter at locations distal to the distal end of the balloon and proximal to the proximal end of the balloon and covering the securing structure of Tsutsui; therefore the modified device would encompass the limitation above as the cover member covers the entire balloon and thus the securing member (band 30)).
Regarding claim 11, as discussed above, it would have been obvious to modify the balloon catheter of Tsutsui to incorporate the covering member of Bohn and in view of Osborn. Additionally, the combination teaches wherein the covering member (cover 500 – Bohn) is longer than the securing structure (band 30 – Tsutsui) in a direction connecting the distal end and the proximal end of the shaft (Examiner’s note: as stated in the rejection of claim 1, the prior art makes obvious wherein the cover 500 of Bohn is attached to the balloon catheter at locations distal to the distal end of the balloon and proximal to the proximal end of the balloon and covering the securing structure of Tsutsui; thus the cover 500 covers the entire balloon and would be longer than the band 30 which sits on only a portion of the balloon).
Regarding claim 12, as discussed above, it would have been obvious to modify the balloon catheter of Tsutsui to incorporate the covering member of Bohn in view of Osborn. Additionally, the combination teaches wherein the covering member (cover 500 – Bohn) is longer than the balloon (balloon 20 – Tsutsui) in the direction connecting the distal end and the proximal end of the shaft (Examiner’s note: as stated in the rejection of claim 1, the prior art makes obvious wherein the cover 500 of Bohn is attached to the balloon catheter at locations distal to the distal end of the balloon and proximal to the proximal end of the balloon and covering the securing structure of Tsutsui; thus the cover 500 would be longer that the balloon 20 as it extends past the balloon in both directions).
Regarding claim 13, as discussed above, the combination of Tsutsui, Bohn, and Osborn teaches the catheter of claim 1. Additionally, Tsutsui discloses the securing structure (band 30) has a width (i.e., a length) between 3 and 30mm in a direction connecting the distal end and the proximal end of the shaft (paragraph [0039]).
However, Tsutsui in view of Bohn and Osborn is silent regarding (i) wherein the width (i.e., length) is from 1 mm to 10 mm.
As to the above, Tsutsui discloses overlapping ranges for the length of the securing structure; and it would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05. Thus, the claimed limitations are considered obvious over the teachings of the prior art.
Regarding claim 14, as discussed above, the combination of Tsutsui, Bohn, and Osborn teaches the catheter of claim 1. Additionally, Tsutsui discloses wherein the intermediate portion of the balloon is a straight tube portion having a maximum expansion diameter that is substantially uniform (Examiner’s note: as shown in Fig. 1B the intermediate potion (i.e., the tubular portion) of the balloon is straight and has a uniform diameter), and a length of the straight tube portion in the direction connecting the distal end and the proximal end of the shaft (Examiner’s note: as stated in paragraph [0038] the balloon can have length between 30 to 80mm, therefore, the straight tube portion, which has a length less than the full length of the balloon, can be a length within a range of less than 30mm to less than 80mm).
However, Tsutsui in view of Bohn and Osborn is silent regarding (i) the length being within the claimed range of 10mm to 40mm.
As to (i), and based on the Examiner’s note above, Tsutsui discloses overlapping ranges; and it would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05. Thus, the claimed limitations are considered obvious over the teachings of the prior art.
Regarding claim 15, as discussed above, the combination of Tsutsui, Bohn, and Osborn teaches the catheter of claim 1. Additionally, Tsutsui discloses wherein a length of the intermediate portion of the balloon is some amount longer than a length of the securing structure in a direction connecting the distal end and the proximal end of the shaft (Examiner’s note: as shown in Fig. 1B the intermediate portion (i.e., the none tapered portion) is significantly larger than the length of the band 30 (i.e., the securing structure)).
However, Tsutsui in view of Bohn, and Osborn is silent regarding (i) length of the intermediate portion is two to eight times longer than the length of the securing structure.
As to the above, because Tsutsui discloses that the length of the securing structure is smaller than the length of the intermediate portion of the balloon it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the length of the intermediate portion be two to eight times longer than the length of the securing structure as claimed 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 relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the securing structure (band 30) of Tsutsui would not operate differently with the claimed relative length since securing structure (band 30) of Tsutsui is intended to restrict a portion of the intermediate section and not the entire intermediate section, as shown in Figs. 1A and 1B of Tsutsui. Therefore, the securing structure (band 30) of Tsutsui would function appropriately with the claimed relative length.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Tsutsui et al (US 2015/0174383 A1) (previously cited) in view of Bohn et al (US 2021/0236314 A1) (previously cited), Osborn (US 5,409,495) (previously cited), as applied to claim 1 above, and further in view of Roberts et al (US 5,545,209) (previously cited).
Regarding claim 17, as discussed above, the combination of Tsutsui, Bohn, and Osborn teaches the catheter of claim 1. Additionally, the combination teaches [a portion of claim 17], as Bohn teaches, in paragraph [0077] and shows in Fig. 6, wherein the cover member (cover 500) is attached to the catheter via an adhesive at both ends of the cover (thus not adhesively bonded to the balloon); therefore, because the modification is such that the cover 500 is secured to the catheter of Tsutsui, not the balloon, and because the cover 500 covers the entire balloon and the securing structure (band 30 of Tsutsui), the modified device would encompass wherein the cover member (cover 500) of Bohn is not be bonded to the outer periphery of the balloon or the outer periphery of the securing structure (band 30 of Tsutsui) and is bonded to the catheter as claimed.
However, the combination of Tsutsui, Bohn, and Osborn is silent regarding (i) wherein the securing structure is not bonded to the balloon.
As to the above, Roberts teaches in the same field of endeavor, a balloon catheter comprising a balloon (balloon 54) that is attached to a shaft on a distal end side and is expandable by a fluid supplied from a side of a proximal end of the shaft (col. 11 lines 33 – 55, and Fig. 13B) and a securing structure (constraint 52) that covers an outer periphery of the balloon (Fig. 13B) wound around the intermediate portion of the balloon and configured to limit the expansion of the intermediate portion of the balloon (col. 11 line 57 – col. 12 line 23). Furthermore, Roberts teaches wherein the securing structure (constraint 52) can be friction fitted to the balloon (i.e., not bonded by adhesive) among other means of connection (col. 12 lines 16 – 18).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the securing structure (band part 30) of Tsutsui to not be bonded to the balloon, and be friction fitted to balloon, as taught by Roberts, as friction fitting a securing structure is a known means of securing a known structure to a balloon, and one of ordinary skill in the art would have a reasonable expectation of success in friction fitting the securing structure of Tsutsui to the balloon of Tsutsui, and the modification would be predictable and would result in the modified device being able to operate as intended.
Additionally, it should be understood that Tsutsui and Roberts are known references in the art that teach a balloon catheter comprising an intermediate balloon securing structure (abstract, paragraph [0036] and Fig. 1 – Tsutsui ; abstract, col. 11 lines 20 – 33, col. 11 lines 34 – 40, col. 11 lines 55 – 68, and Fig. 13B – Roberts); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have one means of coupling a securing structure to a balloon for another, and the results of the substitution would have been predictable and resulted in the modified securing structure (band 30) of Tsutsui being coupled to the balloon as intended such that the securing structure (band 30) can operate as intended to restrict the expansion of the balloon. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
Response to Arguments
Applicant’s arguments, filed 02/24/2026, with respect to the rejection of claim 1 under Tsutsui, Bohn, Osborn, and Roberts have been fully considered but are not persuasive. More specifically:
With respect to Applicant’s argument that “Applicant respectfully submits that in the invention, the balloon is folded first, and then the securing structure is attached to the center portion of the folded balloon. In contrast, Fig. 3 and paragraph [0042] of Tsutsui teaches that the band part 30 is first fixed to the balloon part 20 first, and then the shoulder parts 23 of the balloon part 20 is folded. Applicant thus indicates that the combination of Tsutsui, Bohn and Osborn fails to disclose the above-mentioned features of claim 1.”, the Examiner acknowledges the recitation of Tsutsui cited by Applicant above, however, the Examiner notes that paragraph [0042] also recites “The part of which the band part 30 is fixed to the balloon part 20 may be fixed to the front face of the balloon part 20, or as illustrated in FIG. 4, when the balloon part 20 is folded in a wing-like fashion (folded in a so-called umbrella shape), the part may be evenly-fixed to the front end or middle part of each wing.”, thereby teaching wherein the securing structure (i.e., the band part 30) is attached to the folded balloon. Therefore, Applicant’s arguments are not persuasive.
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.
Contact Information
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/Andrew Restaino/Primary Examiner, Art Unit 3771