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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/26/2026 has been entered.
Response to Amendment
This Office action is in response to the applicant’s communication filed 06/26/2026.
Status of the claims:
Claims 1 – 15, 17, and 21 – 22 are pending in the application.
Claims 1 is amended.
Claims 21 – 22 are new.
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.
Claims 1 – 15, 17, and 21 – 22 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), and Roberts et al (US 5,545,209) (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);
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 (i), 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]).
In addition to the teachings of Bohn, 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, wherein both of the securing structure (restraining bands 23) and the covering member (sleeve 24) are utilized to aid in the controlling of the expansion of the balloon (col. 5 lines 5 – 20, col. 5 lines 46 – 65, col. 6 lines 36 – 52, and Fig. 2). Therefore, Osborn teaches it is known to have two means of controlling the radial expansion of the balloon via a covering member covering and a securing structure that are 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, based on the teachings of both Bohn and Osborn, 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 and as discussed above, Osborn teaches having the balloon with the securing member being covered by a cover member, thus, making obvious wherein the modified device is such that the covering member 500 of Bohn covers the band part 30 (i.e., the securing structure) of Tsutsui in the manner claimed. Furthermore, Bohn, in paragraph [0077], teaches and makes obvious having the covering member (cover 500 – Bohn) be fixed to the catheter (outer tube 60 of Tsutsui) at a location proximal to the balloon and at a location distal to the balloon (i.e., on the tip part 40 of the catheter of Tsutsui).
However, the combination of Tsutsui, Bohn, and Osborn is silent regarding (ii) wherein the securing structure is not bonded to the balloon. (Examiner’s note: the term “bonded” is defined two layers held together by an adhesive).
As to (ii), 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; which equates to the band 30 of Tsutsui) 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 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 substituted 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 operable 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.
Regarding claim 2, as discussed above, the combination of Tsutsui, Bohn, Osborn, and Roberts 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, Osborn, and Roberts 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, Osborn, and Roberts 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, Osborn, and Roberts 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, Osborn, and Roberts 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, Osborn, and Roberts 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, Osborn, and Roberts 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 in view of Roberts 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 in view of Roberts 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 in view of Roberts 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 in view of Roberts 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, Osborn, and Roberts 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, Osborn, and Roberts is silent regarding (i) wherein the width (i.e., length) is from 1 mm to 10 mm.
As to the above, Tsutsui teaches 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, Osborn, and Roberts 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, Osborn, and Roberts 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 teaches 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, Osborn, and Roberts 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, Osborn, and Roberts 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.
Regarding claim 17, as discussed above, the combination of Tsutsui, Bohn, Osborn, and Roberts teaches the catheter of claim 1. Additionally, the combination teaches wherein the securing structure is not bonded to the balloon (see explanation in claim 1). Furthermore, 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 (i.e., not adhesively bonded to the balloon); therefore, the modification encompasses wherein the covering member (cover 500) is secured only to the catheter of Tsutsui / not bonded to the securing structure. Therefore, the combination encompasses wherein the securing structure is bonded to none of the balloon and the covering member.
Regarding claim 21, as discussed above, the combination of Tsutsui, Bohn, Osborn, and Roberts teaches the catheter of claim 1. Additionally, Tsutsui discloses wherein the securing structure (band 30) is wound only around the intermediate portion (paragraph [0012] and Figs. 1 – 6D)
Regarding claim 22, as discussed above, the combination of Tsutsui, Bohn, Osborn, and Roberts teaches the catheter of claim 1.
However, the combination is silent regarding (i) wherein a lubricant is added between the outer periphery of the securing structure and the inner periphery of the covering member.
As to the above, Osborn further teaches, in col. 5 lines 20 – 30, wherein a lubricant is added between the securing member (restraining bands 23), the balloon (balloon 22), and the covering member (sleeve 24) for the purpose of offsetting any friction that is imparted by the layers so that the balloon can inflate without additional difficulty.
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 system of Tsutsui in view of Bohn, Osborn, and Roberts to incorporate a lubricant in between the securing structure and the covering member, based on the teachings of Osborn, for the purpose of offsetting any friction imparted between the layers as the balloon expands (col. 5 lines 20 – 30 – Osborn).
Response to Arguments
Applicant’s arguments, filed 06/18/2026 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 specifically pointed out that there is no motivation to combine Bohn and Osborn with Tsutsui” and “Tsutsui uses a non-expansive or low-expansive balloon. Therefore, the issue of overexpansion has already been resolved in Tsutsui, and there is no motivation for a person of ordinary skill in the art to incorporate Bohn's cover (which is specifically designed to prevent overexpansion) into Tsutsui's catheter”, the Examiner acknowledges that Tsutsui uses a non-expansive or low expansive balloon, however, Bohn also teaches, paragraph [0052], the balloon is relatively inelastic / non-complaint; and Osborn teaches it is known to utilize multiple means (the restraining members and the sleeve) to aid in preventing overexpansion of the balloon. Therefore, the combination of Bohn and Osborn make obvious adding the covering member of Bohn to the balloon of Tsutsui.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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/Andrew Restaino/Primary Examiner, Art Unit 3771
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