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 action is in response to the amendment filed on 5/1/2026. In the amendment, claims 8-20 have been cancelled and claims 21-32 have been added.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-7, in the reply filed on 5/1/2026 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21 & 32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 21 & 32 recite ‘wherein the sheath of the second catheter assembly is a multi-layer sheath, wherein one or more layers of the multi-layer sheath comprise at least one laser-cut hypotube, wherein the at least one laser-cut hypotube has a stiffness that varies along a length of the at least one laser-cut hypotube, and wherein a proximal portion of the sheath is stiffer than a distal portion of the sheath’. Claim 21 is a new claim filed with the restriction response on 5/1/2026, therefore, the claim language is not considered part of the original disclosure. There is no support for the second catheter assembly’s sheath to be a multi-layer sheath, it is only disclosed in the original specification/filing that the first catheter assembly’s sheath is a multi-layer sheath.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4-7, 22-24, and 29-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yeung et al. (WO 2011/035327 A1).
Regarding claim 1, Yeung et al. disclose a delivery system (Fig. 3) for an implantable device, the delivery system comprising: a first catheter 26 (Fig. 3) assembly having a handle 30 (Fig. 3) and a sheath 40 extending from the handle in an axial direction, the sheath 40 comprising a steerable section 28 (paragraphs [048]-[051]); a second catheter assembly 24 (Fig. 3) having a handle 30 (Fig. 3) and a sheath 24 comprising a proximal end coupled to the handle 30 (Fig. 3) and a distal end; the sheath of the second catheter 24 assembly extending coaxially through the sheath of the first catheter assembly 26 (Fig. 3); wherein the sheath of the second catheter assembly 24 has a first outer diameter along a first length (see annotated Fig. 3 below) and a second outer diameter along a second length (see annotated Fig. 3 below); wherein the second outer diameter is smaller than the first outer diameter (see annotated Fig. 3 below); wherein the sheath of the second catheter assembly 24 is extendable from a distal end of the sheath of the first catheter assembly by a stroke distance (labeled in annotated Fig. 3 below - the stroke distance being the length of the second outer diameter section since this is the length of the heart valve held thereon which must fully exit the sheath 40 in order to be completely delivered, therefore, the internal second outer diameter section would also need to exit the sheath the same amount); and wherein the second length is greater than or equal to a sum of the stroke distance and a length of the steerable section 28 of the first catheter assembly (see previous parenthetical statement), such that the sheath of the second catheter assembly has the second outer diameter through the steerable section 28 of the first catheter assembly 26 (see annotated Fig. 3 below).
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Regarding claim 4, Yeung et al. further disclose a lubricated coating on an outer surface of the sheath along the second length of the sheath (dip coating of polymer encasement disclosed as being lubricious - paragraph [61]).
Regarding claim 5, Yeung et al. further disclose wherein the lubricated coating comprises a hydrophilic coating (dip coating of polymer encasement disclosed as being lubricious - paragraph [61] notes at least ‘Pebax’ which is hydrophilic).
Regarding claim 6, Yeung et al. further disclose wherein the first outer diameter and the second outer diameter are each less than an inner diameter of the sheath of the first catheter assembly (see annotated Fig. 3 above - both diameter sections are slidable within the inner diameter of the sheath 40, therefore, the diameters are both less than the inner diameter of sheath 40).
Regarding claim 7, Yeung et al. further disclose wherein the first catheter assembly 26 is a steerable catheter assembly (steerable section 28 - paragraphs [048]-[051]), and the second catheter assembly 24 is an implant catheter assembly (Fig. 3 - carries implant heart valve 22).
Regarding claim 22, Yeung et al. disclose a system comprising: a delivery system comprising; a first catheter assembly 26 (Fig. 3) having a handle 30 (Fig. 3) and a sheath 40 (Fig. 3) extending from the handle 30 in an axial direction, the sheath 40 comprising a steerable section 28 (paragraphs [048]-[051]); a second catheter assembly 24 (Fig. 3) having a handle 30 (Fig. 3) and a sheath 24 comprising a proximal end coupled to the handle and a distal end; the sheath of the second catheter assembly 24 extending coaxially through the sheath 40 of the first catheter assembly 26 (Fig. 3); wherein the sheath of the second catheter assembly 24 has a first outer diameter along a first length (see annotated Fig. 3 above) and a second outer diameter along a second length (see annotated Fig. 3 above); wherein the second outer diameter is smaller than the first outer diameter (see annotated Fig. 3 above); wherein the sheath of the second catheter assembly 24 is extendable from a distal end of the sheath of the first catheter assembly by a stroke distance (labeled in annotated Fig. 3 above - the stroke distance being the length of the second outer diameter section since this is the length of the heart valve held thereon which must fully exit the sheath 40 in order to be completely delivered, therefore, the internal second outer diameter section would also need to exit the sheath the same amount); wherein the second length is greater than or equal to a sum of the stroke distance and a length of the steerable section of the first catheter assembly (see previous parenthetical statement), such that the sheath of the second catheter assembly has the second outer diameter through the steerable section 28 of the first catheter assembly 26 (see annotated Fig. 3 above); and an implantable device 22 (Fig. 3) coupled to the second catheter assembly 24 (Fig. 3).
Regarding claim 23, Yeung et al. further disclose wherein the implantable device comprises a heart valve replacement device (both repair and replacement implants are discussed throughout; paragraphs [03]-[05], [40]-[41]).
Regarding claim 24, Yeung et al. further disclose wherein the implantable device comprises a heart valve repair device (both repair and replacement implants are discussed throughout; paragraphs [03]-[05], [40]-[41]).
Regarding claim 29, Yeung et al. further disclose a lubricated coating on an outer surface of the sheath along the second length of the sheath (dip coating of polymer encasement disclosed as being lubricious - paragraph [61]).
Regarding claim 30, Yeung et al. further disclose wherein the lubricated coating comprises a hydrophilic coating (dip coating of polymer encasement disclosed as being lubricious - paragraph [61] notes at least ‘Pebax’ which is hydrophilic).
Regarding claim 31, Yeung et al. further disclose wherein the first outer diameter and the second outer diameter are each less than an inner diameter of the sheath of the first catheter assembly (see annotated Fig. 3 above - both diameter sections are slidable within the inner diameter of the sheath 40, therefore, the diameters are both less than the inner diameter of sheath 40).
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.
Claims 25 & 26 are rejected under 35 U.S.C. 103 as being unpatentable over Yeung et al. (WO 2011/035327 A1) in view of Dixon et al. (US Pub. No. 2018/0296334 A1).
Regarding claims 25 & 26, Yeung et al. disclose wherein the heart valve 22 can be a heart valve repair device (both repair and replacement implants are discussed throughout; paragraphs [03]-[05], [40]-[41]), however, Yeung et al. fail to explicitly disclose the specifics of the heart valve repair device to include a pair of anchors configured to attach to two native leaflets of a native heart valve [claim 25] and wherein the second catheter assembly is configured to open and close the pair of anchors [claim 26].
However, Dixon et al. teach a heart valve repair device and delivery system, wherein the heart valve repair device comprises a pair of anchors configured to attach to two native leaflets of a native heart valve, wherein an inner catheter assembly is configured to open and close the pair of anchors (paragraph [0060]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the heart valve repair device suggested and taught by Dixon et al. since Yeung et al. refers to the repair device 22 in a generic sense and the type of heart valve repair device having a pair of anchors that are closed when implanted are common in the art.
Allowable Subject Matter
Claims 2, 3, 27, & 28 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to further disclose, teach or suggest wherein a difference between the first outer diameter and the second outer diameter is from about 0.25 to about 0.76 mm [claims 2 & 27]; and wherein a transition from the first outer diameter to the second outer diameter forms a smooth taper over a distance of from about 25 mm to about 50 mm [claims 3 & 28].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 June 25, 2026
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