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 Arguments
Applicants’ arguments with respect to the existing 112 rejections have been considered, the 112 rejections of record have been withdrawn.
Regarding the argument filed 10/01/2025 with respect to claim 1, applicant argues Sheps does not disclose the loading configuration with respect to the anchor delivery apparatus. The examiner disagrees, it has been held that when the prior art teaches all of the structural elements of an apparatus how the device is intended to be employed does not differentiate the claimed apparatus from the prior art if the device is capable of being used in that way (MPEP 2114 (II)). See rejection below, the structural elements are taught and the structure in Sheps is capable of having a distal end of an implant transverse to the delivery device and engaged with a first anchor (fig 10h, fig 13d, fig 26d), therefore the structure is capable of being loaded in that way. Further note that “loaded” or “loading” is given its broadest reasonable interpretation, the term can include a wide time frame.
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.
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) are:
An anchor delivery apparatus in claim 1 and 6-10
A cinching member in claim 4
A cinching device in claim 9
A locking mechanism in claim 10
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.
The specification describes the “anchor delivery apparatus” at [0050], “The anchor delivery apparatus 22 can be of any known device for implanting annuloplasty anchors. Non- limiting examples include applier model numbers SG-64, HG-16-62-28, SA-85, HG-19- 90-22, HG-18-90-32, HG-18-90-42 or HA-18-114 available from Medtronic, Inc. of Minneapolis, Minnesota, for example”.
The specification describes the “cinching member” at [0091], “In some examples, the elongated cinching member includes a first end and a second end, wherein the first and second ends are both tensioned during the step of tensioning.”
The drawings depict “cinching device” embodiments, for example Fig 6A.
The specification describes the “locking mechanism” at [0073], “The collet holder 44 is threadably engaged with a nut 48 having a tapered inner surface 50. The collet 46 includes a plurality of radially extending reliefs 52 adjacent a plurality of arms 54 and a central channel56 that receives one or more cinching members 20a. The reliefs 52 allow the arms 54 to be compressed inwardly by external forces (e.g., collet holder 44), to cause an inner diameter of the central channel56 to be reduced to compress one or more cinching members 20a threaded therethrough, thereby maintaining or locking a position of the cinching member(s) 20a”
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.
Claim(s) 1-2, 4-6, and 8-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sheps (US 20150272734 A1).
Regarding claim 1, Sheps teaches a system ([0011]) comprising: a guide catheter ([0468], FIG 2 element 14) defining a guide catheter lumen ([0468], FIG 2 element 14), an anchor delivery apparatus (FIG 2 element 18) at least partially positioned within the guide catheter lumen (fig 2, element 18 is within element 14), the anchor deliver apparatus having a body defining an anchor delivery apparatus lumen (see lumen of element 18 in fig 2) terminating at a distal opening at a distal end of the anchor delivery apparatus (see fig 2, element 18 has a distal end/opening that terminates), the anchor delivery apparatus maintaining a plurality of anchors (FIG 2, see element 32s within element 18), and a fabric implant ([0468, FIG 2 element 26]), the implant having an implant longitudinal axis (stretches lengthwise along element 26) and a distal end (element 26 has a distal end); wherein the implant extends along the body (see element 26 in fig 2 ) such that the implant longitudinal axis (down the length of the implant 26) is generally parallel (see in figure 2 element 18 and 26 are parallel) to a central longitudinal axis (down the length of the element 18) of the anchor delivery apparatus and the implant is loaded into the guide catheter with the distal end (the flat transverse end of the distal portion) of the implant folded over the distal opening of the anchor delivery apparatus in a delivery configuration such that the distal end of the implant is transversely oriented with respect to the distal opening of the anchor delivery apparatus lumen (intended use, the structure can be loaded that way); and with a first anchor of the plurality of anchors engaged with the implant( fig 26d or fig 13D, [0717], first anchor engages with implant, structure is capable of being loaded in that way).
Regarding claim 2, Sheps teaches the system wherein further comprising an elongated member ([0558]) secured to the implant and configured to be tensioned to correspondingly tension the implant ([0558]).
Regarding claim 4, Sheps further teaches wherein an elongated cinching member ([0558]) extends through the implant lumen ([0558]).
Regarding claim 5, Sheps teaches the system wherein the implant (FIG 2 element 222) contacts the body along all of a portion of the implant positioned within the guide catheter lumen ([0573] implant sleeve 26 coupled to anchor delivery apparatus 18, additionally see orientation of element 18 and element 19 in Section C-C in figure 2, further see implant 222 along element 19 in figure 2).
Regarding claim 6, Sheps teaches wherein the implant is draped over an outer surface of the body of the anchor deliver apparatus such that the implant is in contact with the outer surface of the body ([0477],
sleeve coupled to outer surface).
Regarding claim 8, Sheps further teaches wherein the first anchor is configured to provide counter tension when the first anchor is secured to an annulus of a heart valve and tension is applied to the elongated member ([0477]).
Regarding claim 9, Sheps further teaches a cinching device ([0589, spool), the cinching device configured to tension the cinching member ([0589]) to decrease an interior dimension of the implant and an annulus to which the implant is secured ([0589]).
Regarding claim 10, Sheps further teaches a locking mechanism (element 145) configured to lock the cinching member at a cinched length ([0589-0592]).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Sheps (US 20150272734 A1) in view of Hammer (US 20120330410 A1).
Regarding claim 3, Sheps fails to teach the system wherein the implant includes a body and a single fold in the body defining an implant lumen.
Hammer further teaches wherein the implant includes a body and a single fold in the body defining an implant lumen (see figure 1 which depicts flexible implant sleeve 26, the sleeve is folded to create a lumen 25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant system of Sheps with Hammer’s teachings of a flexible implant folded in order to create a lumen would allow for a simple design addition of a fold in the body of the implant which would predictably allow the manipulation of members throughout the implant ([0296]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sheps (US 20150272734 A1) in view of Havel (US 20210059818 A1).
Regarding claim 7, Sheps further teaches wherein the elongated member is attached to the implant ([0558]), wherein the elongated member is configured to be tensioned to force the implant against an outer surface of the anchor delivery apparatus when the anchor delivery apparatus is inserted into the guide catheter (intended use, the device can be loaded this way the implant rests on the outer surface of the anchor delivery apparatus and the elongate member is configured to tension the implant as desired ([0558], [0573]).
Sheps does not exactly teach an aperture disposed through the anchor delivery apparatus. Havel teaches an annuloplasty delivery catheter (abstract)) wherein an aperture (hole 219, fig 16) is disposed through the anchor delivery apparatus ([0077]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implant system of Sheps with Havel’s teachings of catheter hole, in order to effectively pin the device in place with the elongate member [0071].
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 HANNA LOUISE PASQUALINI whose telephone number is (703)756-1984. The examiner can normally be reached Telework 7:30PM-5:00PM EST M-F (occasionally off Fridays).
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/H.L.P./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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