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 Arguments
Applicant's arguments filed 12/08/2025 have been fully considered but they are not persuasive.
Applicant argues that Zhang fails to teach “wherein the catheter consists of three balloons” as required in claim 1. Applicant explains that Zhang teaches only a single balloon surrounded by electrodes or conduits, not balloons.
The examiner respectfully disagrees. The seventh paragraph on page 3 of Zhang describes, in regards to Fig. 1 of Zhang, a plurality balloons 10 arranged in a circular array, wherein each balloon is paced apart to allow blood to pass through and explicitly states “In this embodiment, three balloons 10 are provided. In other embodiments, two, four, or more balloons 10 may be provided”. Therefore, Zhang teaches the limitation as claimed.
Applicant argues that Zhang is directed to an electrical shockwave device not mechanical dilation and therefore is structurally and conceptually unrelated to a three-balloon mechanical dilation system in the claimed invention.
In response to applicant's argument that Zhang is directed to an electrical shockwave device not mechanical dilation, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case, Zhang is only used to teach that it is known in the related art of balloon catheters of used for aortic valvuloplasty (Fig. 1, page 3, sixth and seventh paragraphs of Zhang) that a balloon catheter consisting of three balloons (page 3, seventh paragraph of Zhang) is known. Therefore, one of ordinary skill in the art would conclude from the teaching of Zhang that balloon catheter consisting of three balloons is a known alternative to a balloon catheter comprising two balloons (see seventh paragraph of Zhang).
Applicant argues that it would not have been obvious to have combined the teachings of Zhang with Fagan because the technical fields and purposes of Fagan and Zhang are fundamentally different.
The examiner respectfully disagrees. In response to applicant's argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the main intention of the Fagan reference is for utilizing at least two balloons (col. 3 lines 54-56 of Fagan). Fagan further contemplates the catheter having more than two balloons (col. 6 lines 30-35 of Fagan) and further includes a second embodiment of the balloon catheter device consisting of three balloons (Fig. 6d, col. 6 lines 39-43 and col. 7 lines 12-13 of Fagan). Zhang in the related art of balloon catheters of used for aortic valvuloplasty (Fig. 1, page 3, sixth and seventh paragraphs of Zhang) teaches that a balloon catheter consisting of three balloons (page 3, seventh paragraph of Zhang) is known and describes that when the balloon catheter is in use, they inflate to contact a lesion within a vessel wall (see page 4, fourth full paragraph of Zhang) in order to treat stenosis in the blood vessel. Therefore, the intended purpose of the devices is the same. Furthermore, one of ordinary skill in the art would understand that the combination of Fagan in view of Zhang would result in a balloon catheter consisting of only three balloons since Fagan already contemplates more than two balloons for their balloon catheter device (col. 6 lines 30-35 of Fagan) and since Zhang teaches that a balloon catheter consisting of three balloons is known in the art (page 3, seventh paragraph of Zhang). Therefore, the rejection is maintained.
Claim Objections
Claim 9 is objected to because of the following informalities:
Claim 9, line 3: “crushes” which should recite “crush”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 recites the limitation "the fluid supply" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the fluid supply” is interpreted as “the fluid supply device”.
Claim 13 recites the limitation "the supply amount" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the supply amount” is interpreted as “a supply amount”.
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.
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.
Claim(s) 1-2 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Fagan et al. (US 5645529) [hereinafter Fagan] in view of Zhang et al. (CN 110604607; see attached English translation) [hereinafter Zhang], Osypka (US 20180133443), Arney (US 5505702) and Duffy et al. (US 20080215018) [hereinafter Duffy].
Regarding claim 1, Fagan discloses a catheter 5 for aortic valvuloplasty (Fig. 5, col. 5 lines 38-44) comprising:
first to second balloons 51, 52 configured to expand and contract due to supply of a fluid and change relative positional relationships (Fig. 5, col. 5 lines 42-52, col. 7 lines 40-41); and
first to second shafts 54, 55 configured to connect to the first to second balloons 51, 52 and supply the fluid to the first to second balloons to cause the first to second balloons to expand and contract independently of each other (Fig. 5, col. 4 lines 16-20 and lines 24-27 and col. 5 lines 50-56),
at least one wire (interpreted as a guidewire) configured to introduce the first to second balloons from outside a body of a patient to an aortic valve (Fig. 5, col. 5 lines 50-52),
wherein each of the first to second shafts 54, 55 comprises a lumen for supplying the fluid to the first to second balloons 51,52 (Fig. 5, col. 4 lines 16-20 and lines 24-27 and col. 5 lines 50-56)
and a third shaft 56 comprising a lumen for inserting the at least one wire (Fig. 5, col. 5 lines 50-56),
wherein the at least one wire includes a first wire (Fig. 5, col. 5 lines 50-56), and the at least one wire is inserted in the lumen for inserting the first wire (Fig. 5, col. 5 lines 50-56),
wherein the first to second balloons 54, 55 are connected and used in combination (col. 4 lines 27-28 and col. 7 lines 32-41) and wherein the catheter comprises two balloons.
Fagan further contemplates the catheter having more than two balloons (col. 6 lines 30-35) and further includes a second embodiment of the balloon catheter device consisting of three balloons (Fig. 6d, col. 6 lines 39-43 and col. 7 lines 12-13).
However, Fagan fails to disclose the catheter of the embodiment shown in Fig. 5 consisting of three balloons, a third shaft configured to connect to the third balloon, wherein the first to third shafts are configured to connect to the first to third balloons at a tip and supply fluid to the third balloon to cause the third balloon to expand and contract independently of the first and second balloons, and wherein the third shaft comprises a lumen for supplying the fluid to the third balloon, wherein the first to third balloons are connected and used in combination.
Zhang in the same field of endeavor of balloon catheters used for aortic valvuloplasty (Fig. 1, page 3, sixth and seventh paragraphs) teaches that it is known in the art to have a balloon catheter consisting of three balloons (page 3, seventh paragraph).
Osypka in the same field of endeavor of balloon catheters used for aortic valvuloplasty (Figs. 1-3, para. 0002, 0029, 0032) teaches that it is known in the art to have first to third balloons 11-13 configured to expand and contract due to supply of a fluid and change the relative positional relationships (Fig. 1, para. 0029-0030), first to third shafts 1-3 configured to connect to the first to third balloons 11-13 at a tip 8 and supply the fluid to the first to third balloons 11-13 to cause the first to third balloons 11-13 to expand and contract independently of each other (Fig. 1, para. 0015, 0029-0030), and at least one wire 7 (interpreted as a guidewire) including a first wire 7 coupled to the tip 8 (Fig. 1, para. 0030), the wire 7 is in a central balloon 11 of the first to third balloons 11-13 and shaft 1 of the first to third shaft 1-3 (Fig. 1, para. 0030), wherein the lumen of shaft 1 is used for supplying the fluid to the central balloon 11 and retaining wire 7 (Fig. 1, para. 0015, 0029, 0030).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the third shaft of Fagan to include the third balloon of Osypka such that the third balloon may be independently inflated via. the lumen of the third shaft while the third shaft retains the guidewire (Fig. 1, para. 0015, 0029-0030), as taught by Osypka, since Zhang teaches that a balloon catheter consisting of three balloons is known in the art (page 3, seventh paragraph of Zhang), since Osypka further teaches that it is known in the art to construct a multi-balloon catheter with the first to third shafts connected to the first to third balloons at the distal tip of the device (Fig. 1, para. 0015, 0029-0030 of Osypka), and since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
However, modified Fagan fails to disclose wherein the at least one wire includes second to third wires being coupled to each other at the tip, along with the first wire, wherein the first to third wires are coupled at the tip while the first to third balloons expand and contract independently of each other.
Arney in the same field of endeavor teaches a balloon dilation catheter 10 (Fig. 1, col. 2 lines 63- 67 and col. 3 lines 1-2), comprising at least one wire 54A, 54B, 58 that introduces first to second balloons 34A, 34B from outside a body of a patient to an occluded artery (Figs. 1-3, col. 4 lines 24-32 and lines 51- 56), wherein the at least one wire 54A, 54B, 58 includes first to third wires 54A, 54B, 58 coupled to each other at a tip 50 (Figs. 1-3, col. 3 lines 54-57 and lines 63-67 and col. 4 lines 1-4), the first wire 58 is a guidewire (col. 4 lines 9-12 and lines 23-27), the second wire (interpreted as support member 54A) is in the first balloon 34A, the third wire (interpreted as support member 54B) is in the second balloon 34B, and both the second and third wires are in shaft 14 (Figs. 1-3, col. 4 lines 51-56 and col. 5 lines 8-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second balloons and shafts in modified Fagan to include the support wires of Arney, thereby producing a device that comprises first to third wires coupled at the tip, in order to provide sufficient rigidity to the first and second balloons to permit ease of advancement within vasculature (col. 3 lines 63-57 and col. 4 lines 1-4 of Arney).
The combination of modified Fagan in view of Arney would result in a product wherein the first to third wires are coupled at the tip since the teaching of Arney provides the second and third balloons with the second and third wires (see rejection above, Figs. 1-3, col. 3 lines 54-57 and lines 63-67 and col. 4 lines 1-4 of Arney) while the first to third balloons expand and contract independently of each other as taught Osypka (Fig. 1, para. 0015, 0029-0030 of Osypka).
However, modified Fagan fails to disclose an additional lumen for inserting the at least one wire, and each of the at least one wire is inserted in the lumen for inserting the first to third wires.
Duffy in the same field of endeavor teaches a multi-balloon catheter 100 comprising first to second shafts each comprising a lumen 115, 125 for supplying fluid to first to second balloons 110, 122 (Fig. 1, para. 0046-0048) and a lumen 116, 128 for inserting at least one wire 140, 142 (Figs. 1, 4-5, para. 0046-0047, 0052-0053), and wherein the at least one wire includes first to second wires 140, 142 being coupled to each other at a tip 130 (Fig. 5, para. 0052-0054) and each of the at least one wire 140, 142 is inserted in the lumen 116, 128 for inserting the first to second wires 140, 142 (para. 0046-0047, 0052-0053).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the first to third shafts in modified Fagan to include wire lumens to accommodate the first to third wires of Duffy in order to prevent entanglement of the wires (para. 0011 of Duffy) and to provide each balloon with support during insertion of the device (para. 0011 of Duffy).
Regarding claim 2, modified Fagan discloses wherein the first wire is in the first balloon and the first shaft, the second wire is in the second balloon and the second shaft (Figs. 1-3, col. 4 lines 51-56 and col. 5 lines 8-14 of Arney), and the third wire is in the third balloon and the third shaft (Fig. 1, para. 0030 of Osypka).
Regarding claim 7, modified Fagan discloses wherein the first to third balloons are configured to be repositioned with each other in a short axis direction, which is coplanar with the aortic valve, in accordance with a shape of the aortic valve so that they are tightly crimped against the aortic valve having an irregular shape to achieve effective dehiscence of the aortic valve (Fig. 3, para. 0034 of Osypka teaches that first to third balloons are configured to be repositioned with each other in a short axis direction, which is coplanar with the aortic valve. Figs. 2-4, col. 1 lines 40-46, col. 7 lines 32-41 of Fagan discloses that the balloons are repositioned with each other in the short axis direction in accordance with a shape of the aortic valve so that they are tightly crimped against the aortic valve having an irregular shape to achieve effective dehiscence of the aortic valve).
Note: “configured to be repositioned with each other in a short axis direction, which is coplanar with the aortic valve, in accordance with a shape of the aortic valve so that they are tightly crimped against the aortic valve having an irregular shape to achieve effective dehiscence of the aortic valve” is interpreted as functional language and intended use of the device. The examiner notes that the claims are directed towards an apparatus, not a method. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Since modified Fagan discloses all of the structural components (i.e. first to third balloons) required for the functional limitation, modified Fagan thereby discloses the functional limitation such that the first to third ballons are capable of be repositioned with each other in a short axis direction, which is coplanar with the aortic valve, in accordance with a shape of the aortic valve so that they are tightly crimped against the aortic valve having an irregular shape to achieve effective dehiscence of the aortic valve. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 8, modified Fagan discloses all of the limitations set forth above in claim 1. However, modified Fagan fails to disclose wherein the first to third balloons include a marker for positioning, thereby accurately grasping the position and posture of the catheter in the body.
Fagan further teaches that it is known in the art to position radiopaque markers on a balloon for positioning, thereby accurately grasping the position and posture of the catheter in the body (col. 7, lines 41-44).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the first to third balloons in modified Fagan to include the marker for positioning, as taught by Fagan, in order to guide a user to the proper placement of the first to third balloons within a lesion (col. 7, lines 41-44 of Fagan).
Regarding claim 9, modified Fagan discloses wherein the first to third balloons are configured to evenly crushes calcium adhering to valve apexes of the aortic valve (Figs. 2-4, col. 1 lines 40-46, col. 7 lines 32-41 of Fagan; see note above in regards to functional language and intended use).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Fagan et al. (US 5645529) [hereinafter Fagan] in view of Zhang et al. (CN 110604607; see attached English translation) [hereinafter Zhang], Osypka (US 20180133443), Arney (US 5505702) and Duffy et al. (US 20080215018) [hereinafter Duffy], as applied to claim 1 above, and further in view of Campbell (US 20150265816).
Regarding claim 6, modified Fagan discloses all of the limitations set forth above in claim 1. However, modified Fagan fails to disclose wherein an identification display material is plated at an end of each of the first to third shafts.
Campbell teaches that it is known in the art to include an identification display material 316a-b, 315a-b plated at a distal end of a shaft 311 (Fig. 7, para. 0036, 0038).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the first to third shafts in modified Osypka to include the identification display material of Campbell in order to allow the user to visualize the device and precisely position the balloons in a target site (para. 0024, 0038 of Campbell).
Claim(s) 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Fagan et al. (US 5645529) [hereinafter Fagan] in view of Zhang et al. (CN 110604607; see attached English translation) [hereinafter Zhang], Osypka (US 20180133443), Arney (US 5505702) and Duffy et al. (US 20080215018) [hereinafter Duffy], as applied to claim 1 above, and further in view of Ho (US 20120116439).
Regarding claim 10, modified Fagan discloses all of the limitations set forth above in claim 1. However, modified Fagan fails to disclose wherein the catheter further comprises a fluid supply device configured to supply fluid to the first to third balloons.
Ho in the same field of endeavor of multi-balloon catheter system 10 (Fig. 2, para. 0033-0034) teaches that it is known in the art to include a fluid supply device 14 configured to supply fluid to first to third balloons 20a via. inflation conduit 22 delivering fluid to respective inflation connectors 24 (Fig. 2, para. 0034-0036).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Ho (i.e. inflate a plurality of balloons via. inflation system comprising the fluid supply device, inflation conduit and inflation connectors) to the device of modified Fagan would have yielded predicable results, namely, a way to deliver inflation fluid from the fluid supply device to the first to third balloons to inflate the first to third balloons (para. 0035-0036 of Ho).
Regarding claim 11, modified Fagan discloses wherein the fluid supply device, as taught by Madrid (para. 0095 of Madrid), supplies the fluid to the first to third balloons through to the first and third shafts (para. 0095 of Madrid; para. 0029-0030 of Osypka).
Regarding claim 12, modified Fagan discloses wherein the fluid supply device 14 includes a separator 22 that distributes a preset amount of fluid (interpreted as the amount of fluid to inflate the balloons) to the first to third balloons (para. 0035 of Ho) and a controller 14 that supplies the allocated fluid to each of the first to third balloons (para. 0035-0036 of Ho).
Regarding claim 13, modified Fagan discloses wherein the fluid supply (interpreted as the fluid supply device, see 112b rejection above) is configured to set with an upper limit value of the supply amount in accordance with the first to third balloons in order to prevent the first to third balloons from over expanding (Figs. 4A-B, para. 0020, 0029 of Ho, see note below).
Note: “configured to set with an upper limit value of the supply amount in accordance with the first to third balloons in order to prevent the first to third balloons from over expanding” is interpreted as functional language and intended use of the device. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Modified Fagan discloses the structural component required i.e. the fluid supply device for the functional limitation (Fig. 2, para. 0034-0036 of Ho). Therefore, modified Fagan discloses the functional limitation of a fluid supply device capable of being set with an upper limit value of the supply amount in accordance with the first to third balloons in order to prevent the first to third balloons from over expanding. For example, para. 0034-0036 of Ho teaches that the fluid supply device (interpreted as inflation controller 14) supplies fluid to the balloons to expand the balloon against a wall of the aortic arch (see Fig. 4B, para. 0039) without damaging or overexpanding the wall of the aortic arch. The examiner notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention the must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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 LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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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.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771