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 .
Election/Restrictions
Applicant’s election without traverse of the invention of Group I and Species A in the reply filed on 11/6/25 is acknowledged.
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 11/6/25. The claims 13, 17-34 are pending. Claims 1-12, 14-16 have been cancelled.
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, 17-34 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 ends of the at least one attachment tether ([0077]);
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 (end of the post 42) configured to extend through the looped ends of the at least one attachment tether ([0077]);
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 the plurality of 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 collapsed 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 (free end of the post 42);
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 collapsed 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 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 (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 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]).
Conclusion
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.
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/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799