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
Amendments presented objections presented in the office action mailed 07/15/2026. All objections are now withdrawn.
Applicant's arguments filed 07/15/2026 have been fully considered are found to be in part persuasive. Applicant argues on pages 8-9 Spence does not teach using an annuloplasty ring. Examiner agrees with applicant’s assessment; new grounds of rejection (necessitated by amendment) detailed below does not rely on Spence for the basis of an annuloplasty ring — Examiner notes that Spence merely points out an annuloplasty ring is not the preferred embodiment of the disclosure. However, Applicant further argues Spence is incompatible with solid annuloplasty rings that have solid inner cores. Examiner respectfully disagrees, the combination detailed below (using a new primary reference to supply the basis of the claimed annuloplasty ring and tethering system), relies in part on the use of elements from Spence- it does so merely for the use of the tethering system disclosed-, does not work exactly as the claimed invention, the new combination as detailed below is operable with a reasonable expectation of success as outlined in MPEP 2143.01-02 for the basis of a proper case of obviousness.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 4-6, 8-10, 12, 14-16, 19, 22, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190240017 A1 (“Almodovar”) in view of US 8979923 B2 (“Spence”), and further in view of US 20080275551 A1 (“Alfieri”).
Regarding claim 1, Almodovar discloses an annuloplasty ring ([0091] Almodovar teaches the elongate member corresponds to treatment as an implantable annuloplasty ring; Fig 9a-b, elongate member 400; corresponding embodiment Figs 8a-c, annuloplasty ring 300) and tether adjustment system (Figs 1-5b, transcatheter suturing system 100; [0101] teaching using the annuloplasty ring and tethering system together), comprising: an annuloplasty ring (400) including an inner core (Fig 9a-b, borders 414; [0100] teaches borders being internal to ring), the inner core defining a closed peripheral shape surrounding an orifice and the interface closely surrounding the inner core and having a matching shape (Fig 9a-b, [0097]), the inner core defining at least one outwardly-projecting boss (anchors 406) configured to provide a suture anchor (cord 408);
a tether adjusting mechanism including at least one tubular arm (see [0096] steerable catheter) having a length sufficient to extend from the native heart valve annulus through an access incision in the heart and out of the body ([0096] Almodovar teaches an introducer, steerable catheter in system, to introduce from outside body and bringing the implant to a native heart annulus, said catheter would need to have sufficient length), at least one tethering suture (see [0101]).
Almodovar does not disclose anchoring sutures, a solid plastic inner core, tethering sutures and free ends according to the claimed invention.
However, in the same field of endeavor, Spence discloses surgical a tether adjustment system (Spence Fig 40A, magnets 484/482) comprising: a plurality of anchoring sutures (Spence Fig 40A, tensible member 482) adapted to pass through the interface and secure the annuloplasty ring to a native heart valve annulus (Spence Fig 3C, Col 13, lines 61-Col 14, lines 51)
the tethering suture having a length such that a pair of free ends (Spence Annotated Fig 40D below) extends from the subvalvular structure through the outwardly-projecting boss on the inner core and out of the body (Spence Col 3, 29-36, teaches length extending out of body, therefore, the tethering suture of Spence is long enough to suture the bosses Almodovar);
the pair of free ends passing through the tubular arm (Spence Col 9, 36-54, teaches passing through delivery catheter),
the pair of free ends having a first end and a second end (Spence Col 9, 36-54); and a tensioner (Spence Fig 40D, flexible tensile member 506) that receives the second end (Spence Col 9, 36-54),
the tubular arm having sufficient column strength such that tension on the second end caused by the tensioner decreases the distance between the subvalvular structure and the annuloplasty ring (Spence Col 20, lines 50-64), at which point the first and second ends are configured to tie off to the outwardly-projecting boss (Spence is fully capable of being tied off to the outward bosses of Almodovar).
at least one tethering suture (Fig 40, tensile member 488, Col 25, lines 1-20) configured to loop (Col 13, lines 61-Col 14, lines 51) through subvalvular structure in a chamber below the native heart valve annulus and tie off thereto (Spence Col 13, lines 61-Col 14, lines 51),
PNG
media_image1.png
324
686
media_image1.png
Greyscale
Annotated Figure 40D Spence et al.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify tensioning system of Almodovar to incorporate the claimed sutures and pair ends, as taught and suggested by Spence in order to secure an implant (Spence Col 20, lines 50-64).
Almodovar and Spence do not disclose the inner core according to the claimed invention.
However, in the same field of endeavor, Alfieri discloses annuloplasty ring (Fig 7a-b, annuloplasty ring; [0047]) comprising a solid inner core made of an elastic-plastic material (silicone rubber and elastic quality are taught, see [0015] and [0048]) and covered by an outer suture-permeable interface ([0015] teaches suture permeable fabric outer layer).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify annuloplasty ring of Almodovar to incorporate an inner solid core and suture-permeable interface as claimed, as taught and suggested by in order to allow additional securing positions along the annulopasty ring (Alfieri [0050]).
Regarding claim 2, Almodovar further discloses wherein there are at least two outwardly- projecting bosses spaced apart around the inner core (Figs 7a-b).
Regarding claim 4, Alfieri further discloses wherein the interface includes a silicone inner portion surrounded by a fabric cover (see [0015] and [0048]).
Regarding claim 5, Almodovar further wherein the annuloplasty ring is adapted to be implanted at the mitral annulus (see [0003-0004]), and the inner core peripheral shape is a rounded D-shape ([0097] teaches D-shape) with an anterior segment on a substantially straight side opposite a more curved posterior segment (see Fig 8a), and wherein the at least one outwardly-projecting boss is located in the posterior segment *see Fig 8a).
Regarding claim 6, Almodovar further discloses the inner core defines a major axis (Annotated Fig 9a below) across a long dimension perpendicular to a minor axis, wherein the anterior segment (side facing away) and the posterior segment (side facing viewer) are on opposite sides of the major axis (Annotated Fig 9a below), and wherein there are at least two outwardly-projecting bosses on opposite sides of the minor axis (Fig 9a) and located in the posterior segment (Annotated Fig 9a below).
PNG
media_image2.png
334
602
media_image2.png
Greyscale
Regarding claim 8, Spence further discloses the tether adjusting mechanism (Spence Fig 40A, magnets 484/482) includes a tubular arm (Spence Col 9, 36-54, teaches passing through delivery catheter, (Spence Fig 40B, catheter 490) for each tethering suture (Spence Fig 40A, tensible member 488), and further including a common access sheath (Spence Fig 40B, catheter 490) through which the tubular arms extend (Fig 40B).
Regarding claim 9, Almodovar in view Spence and Alfieri does not disclose a knot pusher as claimed.
However, Spence in another embodiment discloses a similar annuloplasty ring system. Spence also teaches wherein there are at least two outwardly-projecting bosses further including a knot pusher (Spence Fig 21A, pledget 212” holes 22, 224; Col 19, lines 5-9) for advancing knots in each tethering suture through a respective tubular arm to a respective outwardly-projecting boss on the annuloplasty ring (capable of functioning with the bosses of Almodovar.
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Almodovar in view Spence and Alfieri to incorporate a knot pusher as claimed, as taught and suggested by Spence in order to limit suture tearing (Spence Col 4, line 57- Col 5, line 6).
Regarding claim 10, Almodovar further discloses the at least one outwardly-projecting boss comprises a rounded rectangular projection (rectangular base seen in Figs 9a and c) through which a pair of identical apertures extend (apertures also visible but not enumerated).
Regarding claim 12, Almodovar discloses an annuloplasty ring ([0091] Almodovar teaches the elongate member corresponds to treatment as an implantable annuloplasty ring; Fig 9a-b, elongate member 400; corresponding embodiment Figs 8a-c, annuloplasty ring 300) and tether adjustment system (Figs 1-5b, transcatheter suturing system 100; [0101] teaching using the annuloplasty ring and tethering system together), comprising: an annuloplasty ring (400) including an inner core (Fig 9a-b, borders 414; [0100] teaches borders being internal to ring), the inner core defining a closed peripheral shape surrounding an orifice and the interface closely surrounding the inner core and having a matching shape (Fig 9a-b, [0097]), the inner core defining at least two outwardly-projecting bosses space apart around the inner core and (anchors 406) configured to provide a suture anchor (cord 408);
a tether adjusting mechanism including a tubular arm (see [0096] steerable catheter; Figs 3a-f show multiple lumens for adjusting) for each tethering suture, each having a length sufficient to extend from the native heart valve annulus through an access incision in the heart and out of the body ([0096] Almodovar teaches an introducer, steerable catheter in system, to introduce from outside body and bringing the implant to a native heart annulus, said catheter would need to have sufficient length, (see [0101]).
Almodovar does not disclose anchoring sutures, a solid plastic inner core, tethering sutures and free ends according to the claimed invention.
However, in the same field of endeavor, Spence discloses surgical a tether adjustment system (Spence Fig 40A, magnets 484/482) comprising: a plurality of anchoring sutures (Spence Fig 40A, tensible member 482) adapted to pass through the interface and secure the annuloplasty ring to a native heart valve annulus (Spence Fig 3C, Col 13, lines 61-Col 14, lines 51)
the tethering sutures each having a length such that a pair of free ends (Spence Annotated Fig 40D below) extends from the subvalvular structure through one of the outwardly-projecting bosses on the inner core and out of the body (Spence Col 3, 29-36, teaches length extending out of body, therefore, the tethering suture of Spence is long enough to suture the bosses Almodovar);
the pair of free ends passing through the tubular arm (Spence Col 9, 36-54, teaches passing through delivery catheter),
the pair of free ends having a first end and a second end (Spence Col 9, 36-54); and a tensioner (Spence Fig 40D, flexible tensile member 506) that receives the second end (Spence Col 9, 36-54),
the tubular arms having sufficient column strength such that tension on the second end caused by the tensioner decreases the distance between the subvalvular structure and the annuloplasty ring (Spence Col 20, lines 50-64), at which point the free ends are configured to tie off to the outwardly-projecting boss (Spence is fully capable of being tied off to the outward bosses of Almodovar);
and at least two tethering suture (Fig 40, tensile member 488, Col 25, lines 1-20) configured to loop (Col 13, lines 61-Col 14, lines 51) through subvalvular structure in a chamber below the native heart valve annulus and tie off thereto (Spence Col 13, lines 61-Col 14, lines 51),
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the tensioning system of Almodovar to incorporate the claimed sutures and pair ends, as taught and suggested by Spence in order to secure an annulus implant (Spence Col 20, lines 50-64).
Almodovar and Spence do not disclose the inner core according to the claimed invention.
However, in the same field of endeavor, Alfieri discloses an annuloplasty ring (Fig 7a-b, annuloplasty ring; [0047]) comprising a solid inner core made of an elastic-plastic material (silicone rubber and elastic quality are taught, see [0015] and [0048]) and covered by an outer suture-permeable interface ([0015] teaches suture-permeable fabric outer layer).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify annuloplasty ring of Almodovar to incorporate a solid inner core and suture-permeable interface as claimed, as taught and suggested by in order to allow additional securing positions along the annuloplasty ring (Alfieri [0050]).
Regarding claim 14, Alfieri further discloses wherein the interface includes a silicone inner portion surrounded by a fabric cover (see [0015] and [0048]).
Regarding claim 15, Almodovar further discloses the annuloplasty ring is adapted to be implanted at the mitral annulus (see [0003-0004]), and the inner core peripheral shape is a rounded D-shape ([0097] teaches D-shape) with an anterior segment on a substantially straight side opposite a more curved posterior segment (see Fig 8a), and wherein the at least one outwardly-projecting boss is located in the posterior segment *see Fig 8a).
Regarding claim 16, Almodovar further discloses the inner core defines a major axis (Annotated Fig 9a above) across a long dimension perpendicular to a minor axis, wherein the anterior segment (side facing away) and the posterior segment (side facing viewer) are on opposite sides of the major axis (Annotated Fig 9a above), and wherein there are at least two outwardly-projecting bosses on opposite sides of the minor axis (Annotated Fig 9a) and located in the posterior segment (Annotated Fig 9a above).
Regarding claim 19, Almodovar further discloses the at least one outwardly-projecting boss comprises a rounded rectangular projection (rectangular base seen in Figs 9a and c) through which a pair of identical apertures extend (apertures also visible but not enumerated).
Regarding claim 22, Alfieri further discloses the elastic-plastic material [of the inner core] is selected from the group consisting of stainless steel ([0015]).
Regarding claim 24, Alfieri further discloses wherein the elastic-plastic material is selected from the group consisting of stainless steel, titanium alloy (see [0015]).
Claim(s) 3 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Almodovar in view Spence and Alfieri, and further in view US 9775709 B2 (“Miller”).
Regarding claim 3, Almodovar further discloses wherein there are three outwardly-projecting bosses spaced apart around the inner core (Figs 7a-b) but does not explicitly disclose two of which are more closely spaced to each other than from a third.
However, in the same field of endeavor, Miller discloses an implant (implant 122) with three outwardly projecting bosses (Fig 2b, flexible-longitudinal-tension-member-adjusting-mechanisms 240a and b, shown in pairs), two of which are more closely spaced to each other from a third (2a are spaced closer to each other than the left most 2b).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the bosses of Almodovar to incorporate boss spacing as claimed, as taught and suggested by Miller in order to adjust an implant as needed (Miller Col 16, lines 7-49).
Regarding claim 13, Almodovar further discloses wherein there are three outwardly-projecting bosses spaced apart around the inner core (Figs 7a-b) but does not explicitly disclose two of which are more closely spaced to each other than from a third.
However, in the same field of endeavor, Miller discloses an implant (implant 122) with three outwardly projecting bosses (Fig 2b, flexible-longitudinal-tension-member-adjusting-mechanisms 240a and b, shown in pairs), two of which are more closely spaced to each other from a third (2a are spaced closer to each other than the left most 2b).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the bosses of Almodovar to incorporate boss spacing as claimed, as taught and suggested by Miller in order to adjust an implant as needed (Miller Col 16, lines 7-49).
Claim(s) 7 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Almodovar in view Spence and Alfieri, and further in view of US 20200030096 A1 (“Zeitani”).
Regarding claim 7, Almodovar in view Spence and Alfieri do not disclose wherein there are only two outwardly- projecting bosses, one on each side of the minor axis and two tethering sutures.
However, Zeitani teaches wherein there are only two projecting bosses (Fig 7Q, legs 120 [0088]), one on each side of the minor axis and two tethering sutures ([0125] capable of being positioned as described).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Almodovar to incorporate wherein there are only two outwardly-projecting bosses, one on each side of the minor axis and two tethering sutures as taught and suggested by Zeitani in order to provide structural support (Abstract).
Regarding claim 17, Almodovar in view Spence and Alfieri do not disclose wherein there are only two outwardly- projecting bosses, one on each side of the minor axis and two tethering sutures.
However, Zeitani teaches wherein there are only two projecting bosses (Fig 7Q, legs 120 [0088]), one on each side of the minor axis and two tethering sutures ([0125] capable of being positioned as described).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the combination of Spence and Marquez to incorporate wherein there are only two outwardly-projecting bosses, one on each side of the minor axis and two tethering sutures as taught and suggested by Zeitani in order to provide structural support (Abstract).
Claim(s) 11 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Almodovar in view of Spence and Alfieri, and further in view of Schweich et al. US 20130282110 A1, herein referred to as Schweich.
Regarding claim 11, Almodovar in view Spence and Alfieri do not disclose wherein the at least one outwardly-projecting boss comprises a T-shaped projection having rounded ends.
Schweich discloses an implant with bosses. Schweich teaches wherein the at least one outwardly-projecting boss comprises a T-shaped projection having rounded ends (Fig 50, 302).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Almodovar to incorporate wherein the at least one outwardly-projecting boss comprises a T-shaped, as taught and suggested by Schweich in order to provide structural support (Abstract).
Regarding claim 20, Almodovar in view Spence and Alfieri do not disclose wherein the outwardly-projecting bosses each comprises a T-shaped projection having rounded ends (Fig 50, 302).
Schweich discloses an implant with bosses. Schweich teaches wherein the at least one outwardly-projecting boss comprises a T-shaped projection having rounded ends (Fig 50, 302).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Almodovar to incorporate wherein the at least one outwardly-projecting boss comprises a T-shaped, as taught and suggested by Schweich in order to provide structural support (Abstract).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Almodovar in view of Spence and Alfieri, and further in view US 20040210305 A1 (“Shu”)
Regarding claim 18, Spence further discloses three tethering sutures (Spence Col 9, lines 1-36, teaches a plurality of sutures). Almodovar, in view of Spence and Alfieri, do not disclose wherein there are only three outwardly- projecting bosses.
However, in the same field of endeavor, Shu discloses a heart implant (Fig 2, valve stent 40) comprising bosses (Fig 3, posts 51-53), wherein there are only three outwardly- projecting bosses (Fig 3).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the number of Almodovar’ bosses, as taught and suggested by Shu in order to supporting other implantable structures implanted with the primary implant of interest, the annuloplasty ring (Shu [0090]).
Claim(s) 21 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Almodovar in view of Spence and Alfieri, and further in view of US 20090299470 A1 (“Rao”).
Regarding claim 21 and 23, Almodovar in view of Spence and Alfieri do not disclose the inner core has a generally rectangular radial cross-section.
However, in the same field of endeavor, Rao discloses an annuloplasty ring (Figs 11a-b, annuloplasty ring 22) with an inner core (Figs 12a-b, inner core 60), wherein the inner core has a generally rectangular radial cross-section (Figs 12a-b).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the annuloplasty ring inner core Almodovar in view Alfieri to incorporate the claimed radial cross-section, as taught and suggested by Rao in order to provide structural rigidity (Rao [0089]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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, Jerrah Edwards can be reached at (408) 918-7557. 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.
/A.F./Patent Examiner, Art Unit 3774
/MATTHEW F DESANTO/Primary Examiner, Art Unit 3700
Prosecution Insights