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 entered in response to Applicant's amendment and reply of 5/15/26. The claims 13, 17-36 are pending. The claims 13, 19, 21, 22, 26, 28, 32 are amended. Claims 35 and 36 are new.
Response to Arguments
Applicant’s arguments, filed 5/15/26 with respect to the rejections of claims 13, 17-34 under 35 U.S.C. 102(a)(1) as being anticipated by Crowley (US2017/0216029) have been fully considered but the arguments are not persuasive. Examiners position is the same as what is presented in the rejection below. The Crowley reference discloses “the release tether comprises a free end capable of at least partially wrapping around a longitudinal axis defined by a distalmost portion of the shaft” as recited in claim 13; the free end of the release tether is “configured to be positioned radially outside the shaft after the replacement heart valve transitions to an expanded configuration” as recited in claim 19; “the one or more release tethers comprise a free end configured to at least partially wrap around an axis of the replacement heart valve, the axis extending from a proximal end of the replacement heart valve to a distal end of the replacement heart valve” as recited in claim 26 as discussed in the rejections below.
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: “retention member” in claim 26. For examination purposes the “retention member” is interpreted as a “ring and can include a plurality of slots configured to engage with struts of the prosthesis 70” as described in paragraph [0155] of the instant specification and equivalents thereof.
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 § 102
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 13, 17-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Crowley (US2017/0216029).
Regarding claim 13, Crowley discloses a delivery system for a replacement heart valve ([0059]), the delivery system comprising:
a shaft (14) having a proximal end and a distal end;
a manifold (50) on a distal end of the shaft, wherein the manifold comprises a plurality of radially extending apertures (54, 56);
at least one attachment tether (90) configured to releasably connect to the replacement heart valve ([0079]), wherein looped portions (94) of the at least one attachment tether extend through the radially extending apertures of the manifold; and
a release tether (42) configured to extend through the looped portions of the at least one attachment tether ([0077]; Fig. 4), the release tether comprising a free end (post 42 extends to a free end, see Fig. 5) capable of at least partially wrapping around a longitudinal axis defined by a distalmost portion of the shaft (the free end of 42 is interpreted as wrapping around a longitudinal axis by extending radially along a longitudinal axis defined by the shaft; otherwise the post 42 is capable of bending partially around a longitudinal axis defined by the shaft);
wherein when the release tether is withdrawn from the looped portions ([0080]), the replacement heart valve is released from the at least one attachment tether ([0081]).
Regarding claim 17, Crowley discloses the delivery system of Claim 13, wherein the at least one attachment tether comprises one and only one attachment tether (attachment tether can be single filament 90, [0079]).
Regarding claim 18, Crowley discloses the delivery system of Claim 13, wherein the at least one attachment tether comprises a plurality of attachment tethers (attachment tether can be a plurality of filaments 90, [0079], see Fig. 4).
Regarding claim 19, Crowley discloses a delivery system for a replacement heart valve ([0059]), the delivery system comprising:
a shaft (14) having a proximal end, a distal end, and a lumen (see Fig. 1, [0060]);
a handle (18) coupled to the proximal end of the shaft;
a manifold assembly (50) configured to be positioned on or within the shaft (see Fig. 6), the manifold assembly comprising at least one attachment tether (90) configured to releasably connect to the replacement heart valve ([0079]), the at least one attachment tether comprising looped ends (94); and
a release tether (42) having a free end (post 42 extends to a free end, see Fig. 5) configured to extend through the looped ends of the at least one attachment tether ([0077]) and configured to be positioned radially outside the shaft after the replacement heart valve transitions to an expanded configuration (posts 42 are at least capable of being advanced out of the shaft and moved radially outward from the shaft after the heart valve is deployed, see Fig. 9, where cleat posts 42 on the cleat disc 40 is movable from the assembly);
wherein the release tether is configured to withdraw from the looped ends ([0080]) such that the replacement heart valve is released from the at least one attachment tether ([0081]).
Regarding claim 20, Crowley discloses the delivery system of Claim 19, wherein the at least one attachment tether (90) is configured to extend through at least one eyelet (eyelet is interpreted as the opening in the crown portion 98) of a replacement heart valve prosthesis (see Fig. 6).
Regarding claim 21, Crowley discloses the delivery system of Claim 19, wherein at least one attachment tethers comprises 9 attachment tethers (three filaments 90 may be coupled to each cleat post 42, [0078]; where there may be three cleat posts 42, [0074]).
Regarding claim 22, Crowley discloses the delivery system of Claim 19, wherein the replacement heart valve is configured to transition from a compressed configuration to a fully expanded configuration, wherein the at least one attachment tether is configured to releasably connect to the replacement heart valve such that the replacement heart valve can transition to the fully expanded configuration while remaining connected to the delivery system ([0067], [0072]).
Regarding claim 23, Crowley discloses the delivery system of Claim 19, wherein the release tether comprises a plurality of release tethers (include a plurality of posts 42, [0074], see Fig. 4).
Regarding claim 24, Crowley discloses the delivery system of Claim 23, wherein individual release tethers are configured to extend through multiple looped ends ([0074], see Fig. 4).
Regarding claim 25, Crowley discloses the delivery system of Claim 19, wherein the release tether is configured to be pulled to withdraw the release tether and enable the looped ends to detach the looped ends from the replacement heart valve ([0081]).
Regarding claim 26, Crowley discloses a delivery system for a replacement heart valve ([0059]), the delivery system comprising:
a shaft (14) having a proximal end and a distal end (see Fig. 1, [0060]);
a retention member (50, where 50 is interpreted under 112(f) as a “retention member” by being a ring, which is shaped like a disk and for holding the valve as shown in Fig. 6) on or within a distal end portion of the shaft (see Fig. 6);
a plurality of attachment tethers (90, where 90 can be a plurality of filaments, [0079], see Fig. 4) at least partially disposed within the shaft ([0076], see Fig. 6) and configured to releasably couple to a replacement heart valve ([0079]), the plurality of attachment tethers comprising looped ends (94); and
one or more release tethers (42) configured to extend through at least some of the looped ends of the plurality of attachment tethers ([0077]), the one or more release tethers comprising a free end (post 42 extends to a free end, see Fig. 5) configured to at least partially wrap around an axis of the replacement heart valve (the free end of 42 is interpreted as wrapping around a diagonal axis of the heart valve by extending along the diagonal axis defined heart valve; otherwise the post 42 is capable of bending partially around a axis defined by the heart valve), the axis extending from a proximal end of the replacement heart valve to a distal end of the replacement heart valve (diagonal axis of the heart valve defined from one point on one side of a proximal end to another point on the opposite side on the distal end);
wherein the delivery system is configured to transition from a first configuration (first configuration is interpreted as the “deployed” configuration when the valve is expanded but the filaments 90 are not pulled from the post 42, [0072]) to a second configuration (second configuration is interpreted as the “release” configuration when the filament 90 is pulled from the post 42 to release the valve, [0072]);
wherein the delivery system is in the first configuration when the one or more release tethers are extended through at least some of the looped ends of the plurality of attachment tethers ([0077]);
wherein the delivery system is in the second configuration when the one or more release tethers are withdrawn from at least some of the looped ends of the plurality of attachment tethers ([0080]);
wherein the replacement heart valve is inhibited from decoupling from the plurality of attachment tethers when the delivery system is in the first configuration ([0067], [0072]), and the replacement heart valve is configured to be released from the plurality of attachment tethers after the delivery system is in the second configuration ([0067], [0072]).
Regarding claim 27, Crowley discloses he delivery system of Claim 26, wherein the plurality of attachment tethers (90) is configured to extend through eyelets (eyelet is interpreted as the opening in the crown portion 98) of a replacement heart valve prosthesis (see Fig. 6).
Regarding claim 28, Crowley discloses the delivery system of Claim 26, wherein the replacement heart valve is configured to transition from a compressed configuration to a fully expanded configuration, wherein the plurality of attachment tethers is configured to releasable couple to the replacement heart valve such that the replacement heart valve can transition to the fully expanded configuration while remaining coupled to the delivery system ([0067], [0072]).
Regarding claim 29, Crowley discloses the delivery system of Claim 26, wherein the one or more release tethers comprises a plurality of release tethers (include a plurality of posts 42, [0074], see Fig. 4).
Regarding claim 30, Crowley discloses the delivery system of Claim 29, wherein individual release tethers are configured to extend through multiple looped ends ([0074], see Fig. 4).
Regarding claim 31, Crowley discloses delivery system of Claim 26, wherein the replacement heart valve is configured to cinch the plurality of attachment tethers (the posts 42 are cinched by the filaments 90 that are connected to the heart valve, therefore the heart valve at least indirectly cinches the posts 42, [0077]).
Regarding claim 32, Crowley discloses delivery system of Claim 26, wherein the release tether are configured to be pulled to withdraw the one or more release tether and enable the looped ends to detach the looped ends from the replacement heart valve (see Figs. 7 and 8).
Regarding claim 33, Crowley discloses the delivery system of Claim 26, wherein a portion of the individual attachment tethers are attached to the shaft (at least indirectly attached to the shaft 14 by the coupler 50, [0074]).
Regarding claim 34, Crowley discloses the delivery system of Claim 26, wherein the plurality of attachment tethers are attached to the retention member (disc 40 is attached to the coupler 50 by extending within it, [0074]).
Regarding claim 35, Crowley discloses the delivery system claim 26, wherein the retention member comprises a ring (cleat disc 40 has a lumen 44 and is cylindrical and therefore interpreted as ring, [0074]) comprising one or more slots (lumen 44) configured to engage struts of the replacement heart valve (actuator element 84 that passes through lumen 44 can retract and medical implant 16 toward the lumen 44 and is therefore capable of having the lumen 44 engage the medical implant/heart valve, [0086]).
Regarding claim 36, Crowley discloses the delivery system 26, wherein the retention member comprises a manifold (disc 40 is interpreted as a manifold by having an aperture for output) having one or more radially extending apertures (lumen 44, [0074]), wherein the plurality of attachment tethers are configured to pass through the one or more apertures of the manifold (attachment tethers 90 are at least capable of passing through lumen 44 by being of a size that can pass through the lumen 44, see Fig. 4).
Conclusion
THIS ACTION IS MADE FINAL. 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 MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.M/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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