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 .
Status of Claims
This office action is responsive to the amendment filed on 02/10/2026. As directed by the amendment: claim 18 has been amended, claims 41 and 42 have been cancelled and new claim 43 has been added. Thus, claims 18-22, 25-27, 31-36, 38-40 and 43 are presently pending in this application, and currently examined in the Office Action.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
Claims 18-22, 25-27, 31-36, 38-40 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Ellis et al. (US PG Pub. 2012/0065464), as previously disclosed, hereinafter Ellis, in view of Keranen (US PG Pub. 2008/0208330).
Regarding claims 18, 19 and 38, Ellis discloses a medical arrangement (1), illustrated in Figure 42, configured to introduce an object from a distal end of the arrangement into an anatomical target position/annulus area of a mitral valve ([0017]), said medical arrangement (1) comprising said object (1040), which is an implant to treat mitral valve regurgitation ([0080], Lines 1-4), and a first introducer (1000) having distal and proximal ends (1016 & 1014, respectively); and a second introducer (1020) having distal and proximal ends (1026 & 1024, respectively); wherein said first introducer (1000) is an outer introducer and said second introducer (1020) is configured to be operated inside and guided by said first introducer, illustrated in Figure 42 ([0170]); at least a portion of said first introducer (1000) is configured to take a first curved shape (1100), when said first introducer is delivered towards or into said anatomical target position, and at least a portion of the second introducer (1020) is configured to take a second curved shape (1070), to a same hand direction as said first curved shape when the second introducer is introduced from the distal end of the first introducer; wherein said first and second curved shapes are concentric curved shapes; said portions of the first and second introducers (1000 & 1020, respectively) configured to take the first and second curved shapes (1110 & 1070, respectively) are further configured to form an angle/lift into a direction perpendicular to the mitral plane with respect to an axis that is parallel to the mitral plane, whereby the first and second introducers take a helical form; said second introducer (1020) is configured to take at least one additional curved shape (1104), where said additional curved shape is configured to be located between said second curved shape (1070) and the proximal end (1024) of the second introducer (1020); and the additional curved shape (1104) is further concentric with the first and second curved shapes (1110 & 1070, respectively), wherein the additional curved shape (1104) has a different curvature radius than the second curved shape (1070), examples illustrated in Figures 42-43C and 46A-46D ([0171]; [0172]; [0177] – [0180] & [0188] – [0190] – to clarify, it is stated that the first and second introducers can be steerable/have steering mechanisms which allow each introducer to have the ability to have curvature(s) in any direction and about various axes, or on the same plane); and said first introducer (1000) is configured to be delivered into a first side of the annulus of the mitral valve (MV) essentially in a mitral plane at an angle less than 30º in relation to the mitral plane, illustrated in Figure 45A ([0168] & [0182], Lines 13-15); it is to be noted that though it is not specifically disclosed the first introducer is delivered at an angle less than 30º, it can be seen in the example illustrated in fig. 45A, and Ellis states the delivery approach disclosed serves merely as an example and other approaches may also be used based on application and/or target site, and this parameter is also deemed to be functional language/intended use, and the final structure of the medical arrangement would be capable of meeting, i.e. has the physical/structural ability to meet, the function/intended use of the first introducer being delivered at an angle less than 30º; additionally, though it is not specifically disclosed the first and second introducers take a helical form, Ellis does state that the introducers/catheters can be steerable in four directions, allowing for “curvature in any direction and about various axes”, therefore the medical arrangement would be capable of meeting, i.e. has the physical/structural ability to meet, the parameters disclosed above including the first and second introducers take a helical form. Moreover, it can also be said that it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate function/intended use of how to deliver the medical arrangement of Ellis, including having the first introducer being delivered at an angle less than 30º and/or the first and second introducers taking/having a helical form, based on intended use/implantation location (it is important to keep in mind that many of the above parameters, including the first introducer being delivered at an angle less than 30º and the first and second introducers take a helical form, are considered intended use/functional limitations, which do not actually affect and/or change the final structure of the medical arrangement of Ellis). But Ellis does not specifically teach said object/implant having a first loop-shaped structure configured to abut a first side of said mitral valve and a second loop-shaped structure configured to abut a second, opposite, side of said mitral valve.
However, Keranen teaches an implant to treat mitral valve regurgitation, in the same field of endeavor, comprising a first loop-shaped structure configured to abut a first side of said mitral valve and a second loop-shaped structure configured to abut a second, opposite, side of said mitral valve, illustrated in Figures 2 and 3 ([0056] & [0057]); the implant allows for improved mitral valve repair by reshaping the valve annulus in order to improve the function of the mitral valve ([0007]; [0009] & [0010]).
In view of the teachings of Keranen, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the object/implant, of the medical arrangement of Ellis, to comprise a first loop-shaped structure configured to abut a first side of said mitral valve and a second loop-shaped structure configured to abut a second, opposite, side of said mitral valve, in order to allow for improved mitral valve repair by reshaping the valve annulus in order to improve the function of the mitral valve, as taught by Keranen.
Regarding claims 20, 25 and 26, Ellis in view of Keranen disclose the medical arrangement of claim 18, wherein Ellis further teaches a third introducer (300) having distal and proximal ends (324 & 322, respectively), said third introducer is an inner introducer and said second introducer (1020) is configured to be operated between said first introducer (1000) and said third introducer (1030), wherein said first introducer (1000) is an outer steerable catheter, said second introducer (1020) is a steerable catheter, and said third introducer (300) is an inner steerable catheter, such that said first introducer (1000) is configured to be delivered first, said second introducer (1020) is configured to be delivered second, and said third introducer (300) is configured to be delivered third, and said third introducer is configured to take a third curved shape to the same hand direction as the first and second curved shapes of said first and second introducers when said third introducer is introduced from the distal end portion of said second introducer (1020), illustrated in Figures 19 and 42 (Ellis: [0168] & [0228] – [0230]).
Regarding claims 21 and 22, Ellis in view of Keranen disclose the medical arrangement of claim 18, wherein Ellis further teaches said portion (P) of the first introducer (1000) taking said first curved shape (1100) is a distal portion (P) of said first introducer, said distal portion (P) being located between the distal end (1016) and proximal end (1014) of the first introducer (1000); and wherein the first introducer (1000) comprises a third portion (T) between the distal end (1016) and said distal portion (P) taking said second curved shape (1100), wherein said third portion (T) has a different curvature of radius than said portion (P)/is a straight portion, illustrated in Figures 42, 43A and modified figure 43A, below.
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Regarding claim 27, Ellis in view of Keranen disclose the medical arrangement of claim 20, and inasmuch as only the finished structure of the device/medical arrangement bears patentable weight, Ellis in view of Keranen disclose all the structural limitations set forth in the claim(s) of the medical arrangement which would be capable of, i.e. has the physical/structural ability of, performing the function/intended use of having the distal portion of the first introducer be retracted after the second introducer is introduced into said anatomical target position; and therefore, reads on the claim.
Regarding claim 31, Ellis in view of Keranen disclose the medical arrangement of claim 20, wherein Ellis further teaches the second introducer (1020) is configured to be introduced from the distal end (1016) of the first introducer (1000) and wherein at least a distal end (1026) of the second introducer (1020) is configured to be introduced from the distal end (1016) of the first introducer (1000) before the third introducer (300), illustrated in Figures 42-45C (Ellis: [0170] & [0229]).
Regarding claim 32, Ellis in view of Keranen disclose the medical arrangement of claim 20, wherein Ellis further teaches the third introducer (300) is configured to be introduced from the distal end (1026) of the second introducer (1020) before introducing said object (Ellis: [0229]).
Regarding claim 33, Ellis in view of Keranen disclose the medical arrangement of claim 18, wherein Ellis further teaches said portion of the second introducer (1020) configured to take the second curved shape (1070) has a first shape capable of being delivered in a straightened configuration through said first introducer (1000) and is configured to be activated/steered to said at least second curved shape (1070) within or near the anatomical target position, illustrated in Figures 42-43C (Ellis: [0170]; [0177] – [0180] & [0188] – [0190]).
Regarding claim 34, Ellis in view of Keranen disclose the medical arrangement of claim 18, wherein Ellis further teaches said medical arrangement is configured to deliver said object inside the second introducer (1020) into or towards said anatomical target position (MV) after at least the distal end (1026) of the second introducer (1020) is introduced from the distal end (1016) of the first introducer (1000), illustrated in Figures 42-45D (Ellis: [0170] & [0171]).
Regarding claims 35 and 36, Ellis in view of Keranen disclose the medical arrangement of claim 20, wherein Ellis further teaches the first introducer (1000) comprises a flexible portion (1180), being a cutting and/or a material weakening, arranged in an area of the first curved shape and into a casing of the first introducer so that said first introducer is configured to take said first curved shape at said flexible portion and to a direction said flexible portion enables, illustrated in Figures 49A and 49B (Ellis: [0202] & [0203]).
Regarding claim 39, Ellis in view of Keranen disclose the medical arrangement of claim 20, wherein Ellis further teaches said medical arrangement (1) is configured to deliver said object inside the third introducer (300) into or towards said anatomical target position after at least the distal end of the third introducer (300) is introduced from the distal end of the second introducer (1020), illustrated in Figure 42 (Ellis: [0228] & [0229]).
Regarding claim 40, Ellis in view of Keranen disclose the medical arrangement of claim 20, and inasmuch as only the finished structure of the device/medical arrangement bears patentable weight, Ellis in view of Keranen disclose all the structural limitations set forth in the claim(s) of the medical arrangement, which would be capable of, i.e. has the physical/structural ability of, performing the function/intended use of having the distal portion of the second introducer be retracted after the third introducer is introduced into said anatomical target position; and therefore, reads on the claim.
Regarding claim 43, Ellis discloses a kit for introducing an implant from a distal end of a medical arrangement (1), illustrated in Figure 42, into an anatomical target position/annulus area of a mitral valve ([0017]), said kit comprising said implant (1040), which is an implant to treat mitral valve regurgitation ([0080], Lines 1-4), and said medical arrangement (1) which comprises a first introducer (1000) having distal and proximal ends (1016 & 1014, respectively); and a second introducer (1020) having distal and proximal ends (1026 & 1024, respectively); wherein said first introducer (1000) is an outer introducer and said second introducer (1020) is configured to be operated inside and guided by said first introducer, illustrated in Figure 42 ([0170]); at least a portion of said first introducer (1000) is configured to take a first curved shape (1100), and at least a portion of the second introducer (1020) is configured to take a second curved shape (1070), wherein said first and second curved shapes are concentric curved shapes; said portions of the first and second introducers (1000 & 1020, respectively) configured to take the first and second curved shapes (1110 & 1070, respectively) are further configured to form an angle/lift into a direction perpendicular to the mitral plane with respect to an axis that is parallel to the mitral plane, whereby the first and second introducers take a helical form; said second introducer (1020) is configured to take at least one additional curved shape (1104), where said additional curved shape is configured to be located between said second curved shape (1070) and the proximal end (1024) of the second introducer (1020); and the additional curved shape (1104) is further concentric with the first and second curved shapes (1110 & 1070, respectively), wherein the additional curved shape (1104) has a different curvature radius than the second curved shape (1070), examples illustrated in Figures 42-43C and 46A-46D ([0171]; [0172]; [0177] – [0180] & [0188] – [0190] – to clarify, it is stated that the first and second introducers can be steerable/have steering mechanisms which allow each introducer to have the ability to have curvature(s) in any direction and about various axes, or on the same plane); and said first introducer (1000) is configured to be delivered into a first side of the annulus of the mitral valve (MV) essentially in a mitral plane at an angle less than 45º in relation to the mitral plane, illustrated in Figure 45A ([0168] & [0182], Lines 13-15); it is to be noted that though it is not specifically disclosed the first introducer is delivered at an angle less than 45º, it can be seen in the example illustrated in fig. 45A, and Ellis states the delivery approach disclosed serves merely as an example and other approaches may also be used based on application and/or target site, and this parameter is also deemed to be functional language/intended use, and the final structure of the medical arrangement would be capable of meeting, i.e. has the physical/structural ability to meet, the function/intended use of the first introducer being delivered at an angle less than 45º; additionally, though it is not specifically disclosed the first and second introducers take a helical form, Ellis does state that the introducers/catheters can be steerable in four directions, allowing for “curvature in any direction and about various axes”, therefore the medical arrangement would be capable of meeting, i.e. has the physical/structural ability to meet, the parameters disclosed above including the first and second introducers take a helical form. Moreover, it can also be said that it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate function/intended use of how to deliver the medical arrangement of Ellis, including having the first introducer being delivered at an angle less than 45º and/or the first and second introducers taking/having a helical form, based on intended use/implantation location (it is important to keep in mind that many of the above parameters, including the first introducer being delivered at an angle less than 45º and the first and second introducers take a helical form, are considered intended use/functional limitations, which do not actually affect and/or change the final structure of the medical arrangement of Ellis). But Ellis does not specifically teach said implant comprising a first loop-shaped structure configured to abut a first side of said mitral valve and a second loop-shaped structure configured to abut a second, opposite, side of said mitral valve.
However, Keranen teaches an implant to treat mitral valve regurgitation, in the same field of endeavor, comprising a first loop-shaped structure configured to abut a first side of said mitral valve and a second loop-shaped structure configured to abut a second, opposite, side of said mitral valve, illustrated in Figures 2 and 3 ([0056] & [0057]); the implant allows for improved mitral valve repair by reshaping the valve annulus in order to improve the function of the mitral valve ([0007]; [0009] & [0010]).
In view of the teachings of Keranen, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the object/implant, of the medical arrangement of Ellis, to comprise a first loop-shaped structure configured to abut a first side of said mitral valve and a second loop-shaped structure configured to abut a second, opposite, side of said mitral valve, in order to allow for improved mitral valve repair by reshaping the valve annulus in order to improve the function of the mitral valve, as taught by Keranen.
Response to Arguments
Applicant's arguments filed 02/10/2026 have been fully considered but they are not persuasive. Applicant’s argument regarding the newly added parameter is considered moot since, due to Applicant’s current amendments, the secondary reference of Keranen is now used to reject the claims as being unpatentable over Ellis in view of Keranen. Moreover, regarding Applicant’s arguments that Ellis does not teach the “inner and outer guide catheters are capable of being configured such that a portion of one guide catheter forms an angle into a direction perpendicular to the mitral plane with respect to an axis that is parallel to the mitral plane and a portion of the other guide catheter forms an angle into a direction perpendicular to the mitral plane with respect to an axis that is parallel to the mitral plane, whereby the first introducer and second introducer take a helical form”, and that “an infinite number of possibilities would not have been motivation for a modification specifically for the claimed configuration, nor does the possibility of "curvature in any direction and about various axes" mean that Ellis is inherently capable of forming every imaginable configuration, including that which is claimed”; Applicant is reminded that in device/apparatus claims, such as the currently pending claims, only the claimed structure of the final device bears patentable weight and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device, and that device/apparatus claims cover what a device is, not what a device does (see MPEP 2114). Furthermore, Ellis discloses that the curvatures may be formed in the first and second catheters/introducers by steering (Ellis: [0188], Lines 1-2), specifically “to provide a higher degree of control and variety of possible curvatures, steering mechanisms may be used to create the curvatures and position the catheters” (Ellis: [0189], Lines 1-3), and describes a steering mechanism which allows “curvature of the distal end in at least four directions” (Ellis: [0189], Last 12 lines), which would “allow curvature in any direction and about various axes” (Ellis: [0190], Lines 4-5). Hence, contrary to Applicant’s assertion, the disclosure of Ellis clearly teaches a medical arrangement having a structure, in its final manufactured form, which is “inherently capable of forming every imaginable configuration”, i.e. has the physical/structural ability of meeting/achieving the claimed intended use/function(s) as set forth in the claim(s). Thus, the rejection of independent claim 18 is deemed to be proper since all the structural limitations set forth in the claim are taught by Ellis in view of Keranen.
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.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 03/10/2026