DETATILED 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 Group I in the reply filed on 08/14/2026 is acknowledged.
Claims 12-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II-V, there being no allowable generic or linking claim.
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: “coaptation member” in claims 1, 2, and 9 and ‘fixation member” in claims 1, 2, and 8-11.
The specification of the present invention discloses in [0045 and 0050-0053] that the coaptation member can be a baffle structure formed of struts and a covering.
The specification of the present invention discloses in [0045 and 0048-0050] that the fixation member can be an annular structure of struts/mesh.
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
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.
Claim(s) 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zimmerman et al. (US 2022/0079753).
Regarding claim 1, Zimmerman et al. discloses a system (200 and 310, FIG 2A-3) for repairing a cardiac valve ([0038, 0047]), the system comprising: a valve repair device (200) comprising a coaptation member (204, FIG 2A-2B, [0038]) configured to (a) coapt with at least a portion of a first native leaflet of the cardiac valve during systole ([0038]) and (b) displace at least a portion of a second native leaflet of the cardiac valve ([0038]); a fixation member (202, [0038]) extending in a superior direction from the coaptation member (see direction in FIG 2B, [0038]), wherein the fixation member includes a superior end portion (“S”, FIG 2B, [0038]) and an inferior end portion (End towards the direction of ”I”, FIG 2B, [0038]); and at least one connector (205, [0041]) extending radially inward from the fixation member (FIG 2A shows the radially inward positioning) from between the superior end portion and the inferior end portion (FIG 2B); and a delivery system (310, FIG 3, [0047]) configured to position the valve repair device at the cardiac valve ([0047]), wherein the delivery system comprises an implant shaft (316, FIG 4, [0047]) having a hub assembly (436, FIG 4-5F) configured to be releasably coupled to the at least one connector ([0055], 0057-0058]); a drive shaft (552) operably coupled to the hub assembly ([0061]); and a handle (326, [0047 and 0063]) having an actuator (684) operably coupled to the drive shaft ([0063 and 0068], wherein the actuator is the component of the handle directly manipulated by the user), wherein the actuator is actuatable to drive the drive shaft to actuate the hub assembly to release the at least one connector from the hub assembly to decouple the valve repair device from the implant shaft ([0063]).
Regarding claim 2, Zimmerman et al. discloses the coaptation member and the fixation member together extend circumferentially about a vertical axis (“VA”, FIG 2A-2B), and wherein the at least one connector is positioned at a first circumferential position relative to the vertical axis (See location of 205 in FIG 2B), and wherein the coaptation member (204) is positioned at a second circumferential position relative to the vertical axis generally opposite to the first circumferential position (FIG 2B).
Regarding claim 3, Zimmerman et al. discloses the at least one connector comprises a pair of connectors (See 2 connectors identified in FIG 2B).
Regarding claim 4, Zimmerman et al. discloses the actuator (684) is actuatable to drive the drive shaft (552) to actuate the hub assembly (552 rotates 555 which translates 436, [0061, 0068]) to simultaneously release the pair of connectors from the hub assembly (by removing the covering of the recess [0068]) to decouple the valve repair device from the implant shaft ([0068-0070]).
Regarding claim 5, Zimmerman et al. discloses the hub assembly includes an outer hub component (542, FIG 5A and 5D, [0068]) and inner hub component (540) movable through the outer hub component ([0068] “…which drives (e.g., linearly translates) the inner hub component 540 toward and partially out of the distal opening 549 of the outer hub component 542 via the engagement of the threaded outer surface 556 of the lead screw 555 with the threaded portion 553 of the drive lumen 550”), wherein the inner hub component includes an outer surface having at least one recess formed therein (546, FIG 5A and 5B, [0068]) wherein the at least one recess is shaped and sized to receive the at least one connector therein ([0057]), wherein the hub assembly couples the implant shaft to the valve repair device when the at least one connector is positioned with the least one recess and the at least one recess is positioned within and covered by the outer hub component (In the first position of FIG 5A and 5D, [0059]) and wherein the actuator is actuatable to drive the drive shaft to move the inner hub component through the outer hub component (To the second position of FIG 5B and 5E, [0068] and third position of FIG 5C and 5F, [0070]) to uncover the at least one recess from the outer hub component to permit the at least one connector to move out of the at least one recess to decouple the valve repair device from the implant shaft ([0068-0070]).
Regarding claim 6, Zimmerman et al. discloses the hub assembly includes an outer hub component (542, FIG 5A and 5D, [0068]) and inner hub component (540) movable through the outer hub component ([0068] “…which drives (e.g., linearly translates) the inner hub component 540 toward and partially out of the distal opening 549 of the outer hub component 542 via the engagement of the threaded outer surface 556 of the lead screw 555 with the threaded portion 553 of the drive lumen 550”), and wherein the inner hub component has a non-circular shape (Non circular due to the cut outs in the outer surface forming the recesses, see cross section of FIG 5E and 5F) defining a channel between the outer hub component and the inner hub component (As shown in FIG 5D wherein a channel is formed between 542 and 540 by the recesses 544/546).
Regarding claim 7, Zimmerman et al. discloses the valve repair device further includes a clip (209, FIG 2B, [0044]), wherein the delivery system further comprises a clip cable (Tendon, [0073]) releasably operably coupled to the clip and configured to move the clip between an open position and a closed position ([0073]), and wherein the clip cable extends through the channel between the outer hub component and the inner hub component (because the clip is positioned outside of the inner hub component, the tendon is positioned at least partly in the channel between the inner and outer hub components, [0073]).
Regarding claim 8, Zimmerman et al. discloses a delivery system (310, FIG 3, [0047]) for endovascularly implanting a valve repair device (200) at a cardiac valve ([0038, 0047]), the delivery system comprising: an implant shaft (316, FIG 4, [0047]) comprising a distal portion (As shown in FIG 4) having a hub assembly (436, FIG 4-5F), wherein the distal end portion of the implant shaft is configured to be endovascularly delivered to an atrium ([0054]), wherein the hub assembly is configured to be releasably coupled to at least one connector (205, [0055, 0057-0058]) positioned between a superior end portion (“S”, FIG 2B, [0038]) and an inferior end portion (End towards the direction of ”I”, FIG 2B, [0038]) of an expandable fixation member (202) of the valve repair device; a drive shaft (552) operably coupled to the hub assembly ([0061]); and a handle (326, [0047 and 0063]) having an actuator (684) operably coupled to the drive shaft ([0063 and 0068], wherein the actuator is the component of the handle directly manipulated by the user), wherein the actuator is actuatable to drive the drive shaft to actuate the hub assembly to release the at least one connector from the hub assembly to decouple the valve repair device from the implant shaft ([0063]).
Regarding claim 9, Zimmerman et al. discloses the valve repair device includes a coaptation member (204, FIG 2A-2B) configured to (a) coapt with at least a portion of a first native leaflet of the cardiac valve during systole ([0038]) and (b) displace at least a portion of a second native leaflet of the cardiac valve ([0038]), wherein the fixation member extends from the coaptation member (see direction in FIG 2B, [0038]), and wherein the at least one connector is positioned opposite the coaptation member relative to a vertical axis (“VA”) of the valve repair device (FIG 2B shows the relatively opposite positioning of 205 and 204).
Regarding claim 10, Zimmerman et al. discloses a delivery catheter (314), wherein the implant shaft extends through the delivery catheter ([0047]), and wherein the hub assembly is configured to be releasably coupled to the at least one connector when the fixation member is at least partially expanded distal of the delivery catheter ([0054]; FIG 4, 5B and 5E).
Regarding claim 11, Zimmerman et al. discloses the valve repair device extends along a vertical axis (“VA”, FIG 2B), and wherein the hub assembly is configured to be releasably coupled to the at least one connector offset from the vertical axis when the fixation member is at least partially expanded distal of the delivery catheter (Because connectors 205 are located offset from VA as shown in FIG 2B, the hub assembly attaches to the connectors at a location which is also offset from the vertical axis, including in the partially expanded state such as FIG 5B. see location of recesses 544 which receive the connectors is offset).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
Prosecution Insights