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 .
Claim Objections
Claim 1 objected to because of the following informalities: "the pair of free ends of the at least one" grammatical error. Appropriate correction is required.
Claim 1 objected to because of the following informalities: "the at least one tubular arm" grammatical error. Appropriate correction is required.
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) 1-6, 8-10 and 12-16, 18, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spence et al. US 8979923 B2, here in referred to as Spence, and in view of Marquez et al. US 20170258585 A1, herein referred to as Marquez.
RE. Claim 1, Spence discloses an annuloplasty ring (Fig 1D, annuloplasty ring 34) and 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); 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), 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); a tether adjusting mechanism (Spence Fig 40A, magnets 484/482) including at least one tubular arm (Spence Fig 40B, catheter 490) having a length sufficient to extend from the native heart valve annulus through an access incision in the heart and out of the body (Spence Col 3, lines 27-34), the pair of free ends of the at least one tethering suture passing through the at least one 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 at least one 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).
PNG
media_image1.png
722
686
media_image1.png
Greyscale
Annotated Figure 40D Spence et al.
However, Spence fails to disclose an annuloplasty ring including an inner core covered by an outer suture-permeable interface, the inner core defining a closed peripheral shape surrounding an orifice and the interface closely surrounding the inner core and having a matching shape, the inner core defining at least one outwardly-projecting boss configured to provide a suture anchor; at which point, the first and second ends are configured to tie off to the outwardly-projecting boss.
Marquez teaches a similar annuloplasty ring (Marquez Fig 40, annuloplasty ring 3400). Marquez teaches an annuloplasty ring including an inner core (Marquez Fig 18A, coil 1780A) covered by an outer suture-permeable interface (Marquez Fig 17, sheath 983 [0095]), the inner core defining a closed peripheral shape (Marquez [0095], teaches a sealing core ring) surrounding an orifice (Marquez Fig 1, [0080]) and the interface closely surrounding the inner core and having a matching shape (Marquez Fig 18A), the inner core defining at least one outwardly-projecting boss (Marquez Fig 18A, component 1781) configured to provide a suture anchor (capable of securing a suture anchor); at which point, the first and second ends are configured to tie off to the outwardly-projecting boss (capable of being configure top tie off at projecting bosses).
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 Spence to incorporate an annuloplasty ring including an inner core covered by an outer suture-permeable interface, the inner core defining a closed peripheral shape surrounding an orifice and the interface closely surrounding the inner core and having a matching shape, the inner core defining at least one outwardly-projecting boss configured to provide a suture anchor; at which point, the first and second ends are configured to tie off to the outwardly-projecting boss, as taught and suggested by Marquez in order to provide support leaflets [0007].
RE. Claim 2, the combination of Spence and Marquez discloses the invention substantially as claimed and as discussed above with respect to claim 1, but fails to explicitly discloses at least two outwardly-projecting bosses space around the inner core.
But Marquez in another embodiment discloses a similar annuloplasty ring. Marquez also teaches wherein there are at least two outwardly-projecting bosses (Marquez Fig 18A, component 1781, [0251] teaches multiple modules, more than one component 1781) spaced apart around the inner core (Marquez Fig 18A; Marquez Fig 18A, coil 1780A).
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 Spence and Marquez to incorporate wherein there are at least two outwardly-projecting bosses spaced apart around the inner core as taught and suggested by Marquez in order to allow the coupling or additional elements [0015].
RE. Claim 3, the combination of Spence and Marquez discloses the invention substantially as claimed and as discussed above with respect to claim 2 teaches wherein there are three outwardly-projecting bosses spaced apart around the inner core, two of which are more closely spaced to each other than from a third (Marquez [0020], teaches changing post configuration to meet flow needs and is silent regarding a specific arrangement of posts/bosses).
RE. Claim 4, the combination of Spence and Marquez discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the interface includes a silicone inner portion (Marquez [0137]) surrounded by a fabric cover).
RE. Claim 5, the combination of Spence and Marquez discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein the annuloplasty ring is adapted to be implanted at the mitral annulus (Marquez [0077]), and the inner core peripheral shape is a rounded D-shape with an anterior segment on a substantially straight side opposite a more curved posterior segment (Marquez [0137]), and wherein the at least one outwardly-projecting boss is located in the posterior segment (capable being positioned as such).
RE. Claim 6, the combination of Spence and Marquez discloses the invention substantially as claimed and as discussed above with respect to claim 5 teaches wherein the inner core defines a major axis (Marquez [0157], teaches a radial axis, annotated Fig 12 below) across a long dimension perpendicular to a minor axis, wherein the anterior segment and the posterior segment are on opposite sides of the major axis (Marquez annotated Fig 12 below), and wherein there are at least two outwardly-projecting bosses on opposite sides of the minor axis (Marquez Annotated Fig 12 below) and located in the posterior segment (Marquez Annotated Fig 12 below).
PNG
media_image2.png
293
646
media_image2.png
Greyscale
RE. Claim 8, the combination of Spence and Marquez discloses the invention substantially as claimed and as discussed above with respect to claim 1 teaches wherein 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).
RE. Claim 9, the combination of Spence and Marquez discloses the invention substantially as claimed and as discussed above with respect to claim 8, but fails to disclose further including a knot pusher for advancing knots in each tethering suture through a respective tubular arm to a respective outwardly-projecting boss on the annuloplasty ring.
But 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 (Marquez Fig 18A, component 1781, capable of carrying knots to bosses).
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 Spence and Marquez to incorporate further including a knot pusher for advancing knots in each tethering suture through a respective tubular arm to a respective outwardly-projecting boss on the annuloplasty ring, as taught and suggested by Spence in order to limit suture tearing (Col 4, line 57- Col 5, line 6).
RE. Claim 10, the combination of Spence and Marquez discloses the invention substantially as claimed and as discussed above with respect to claim 9 teaches wherein the at least one outwardly-projecting boss comprises a rounded rectangular projection (Marquez Fig 25) through which a pair of identical apertures extend Marquez Fig 16B, meets definition of apertures).
RE. Claim 12, Spence disclose an annuloplasty ring (Fig 1D, annuloplasty ring 34) and tether adjustment system (Spence Fig 40A, magnets 484/482) comprising: a plurality of anchoring sutures (Spence Fig 40A, tensible member 485) 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); and at least two tethering sutures (Fig 40, tensile member 488, Col 25, lines 1-20) configured to loop through subvalvular structure in a chamber below (Spence Fig 4) the native heart valve annulus and tie off thereto (Spence Fig 4), the tethering sutures each having a length such that a pair of free ends (Spence Col 9, 36-54) extends from the subvalvular structure through one of the outwardly-projecting bosses on the inner core and out of the body (Spence Col 9, 36-54), a tether adjusting mechanism (Spence Fig 40A, magnets 484/482) including a tubular arm (Spence Fig 40B, catheter 490) 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 (Spence Col 3, lines 27-34), and further including a common access sheath (Spence Fig 3A, catheter 66a) through which the tubular arms extend (Spence Fig 40b, catheter 490), the pairs of free ends (Spence Annotated Fig 40D below) of the tethering sutures passing through the tubular arms (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 of each tethering suture (Spence Col 9, 36-54), the tubular arms (Spence Fig 3A, catheter 66a, 66b) having sufficient column strength such that tension on the second ends caused by the tensioner decreases the distance between the subvalvular structure and the annuloplasty ring (Spence Col 6, lines 14-46).
However, Spence fails to disclose an annuloplasty ring including an inner core covered by an outer suture-permeable interface, the inner core defining a closed peripheral shape surrounding an orifice and the interface closely surrounding the inner core and having a matching shape, the inner core defining at least two outwardly-projecting bosses spaced apart around the inner core and configured to provide a suture anchor; a plurality of anchoring sutures adapted to pass through the interface and secure the annuloplasty ring to a native heart valve annulus; a pair of free ends extends from the subvalvular structure through one of the outwardly-projecting bosses on the inner core and out of the body, at which point the pairs of free ends are configured to tie off to the outwardly-projecting boss.
Marquez teaches comprising: an annuloplasty ring (Marquez Fig 40, annuloplasty ring 3400); including an inner core (Marquez Fig 18A, coil 1780A) covered by an outer suture-permeable interface (Marquez Fig 17, sheath 983 [0095]), the inner core defining a closed peripheral shape (Marquez [0095], teaches a sealing core ring) surrounding an orifice (Marquez Fig 1, [0080]) and the interface closely surrounding the inner core and having a matching shape (Marquez Fig 18A), the inner core defining at least two outwardly-projecting bosses (Marquez Fig 18A, component 1781) spaced apart around the inner core (Marquez Fig 18A) and configured to provide a suture anchor (capable of securing a suture anchor); a pair of free ends (Spence Annotated Fig 40D above; Col 9, 36-54) extends from the subvalvular structure through one of the outwardly-projecting bosses on the inner core and out of the body (Marquez Fig 18A, component 1781); at which point the pairs of free ends are configured to tie off to the outwardly-projecting boss (Marquez Fig 18A, component 1781, Free ends taught by Spence are capable of tying off to bosses of Marquez).
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 Spence to incorporate an annuloplasty ring including an inner core covered by an outer suture-permeable interface, the inner core defining a closed peripheral shape surrounding an orifice and the interface closely surrounding the inner core and having a matching shape, the inner core defining at least two outwardly-projecting bosses spaced apart around the inner core and configured to provide a suture anchor; a plurality of anchoring sutures adapted to pass through the interface and secure the annuloplasty ring to a native heart valve annulus; a pair of free ends extends from the subvalvular structure through one of the outwardly-projecting bosses on the inner core and out of the body, at which point the pairs of free ends are configured to tie off to the outwardly-projecting bosses taught and suggested by Marquez, in order to provide support leaflets [0007].
RE. Claim 13, the combination of Spence and Marquez discloses the invention substantially as claimed and as discussed above with respect to claim 12, but fails to explicitly disclose wherein there are three outwardly-projecting bosses spaced apart around the inner core two of which are more closely spaced to each other than from a third.
But Marquez in another embodiment discloses a similar annuloplasty ring. Marquez also teaches wherein there are three outwardly-projecting bosses spaced apart around the inner core (Marquez Fig 18A, component 1781, [0251] teaches multiple modules, more than one component 1781), two of which are more closely spaced to each other than from a third (Marquez [0020], teaches changing post configuration to meet flow needs and is silent regarding a specific arrangement of posts/bosses).
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 Spence and Marquez to incorporate wherein there are three outwardly-projecting bosses spaced apart around the inner core two of which are more closely spaced to each other than from a third as taught and suggested by Marquez in order to allow the coupling or additional elements [0015].
RE. Claim 14, the combination of Spence and Marquez discloses the invention substantially as claimed and as discussed above with respect to claim 13 teaches wherein the interface includes a silicone inner portion (Marquez [0137]) surrounded by a fabric cover (Marquez [0137]).
RE. Claim 15, the combination of Spence and Marquez discloses the invention substantially as claimed and as discussed above with respect to claim 12 teaches wherein the annuloplasty ring is adapted to be implanted at the mitral annulus, and the inner core peripheral shape is a rounded D-shape with an anterior segment on a substantially straight side opposite a more curved posterior segment (Marquez [0137]), and wherein the at least one outwardly-projecting boss is located in the posterior segment (Capable of being positioned).
RE. Claim 16, the combination of Spence and Marquez discloses the invention substantially as claimed and as discussed above with respect to claim 15 teaches wherein the inner core defines a major axis (Marquez [0157], teaches a radial axis, annotated Fig 12 above) across a long dimension perpendicular to a minor axis (Marquez annotated Fig 12 above), wherein the anterior segment and the posterior segment on opposite sides of the major axis (capable of being positioned as described), and wherein there are at least two outwardly-projecting bosses on opposite sides of the minor axis and located in the posterior segment (Marquez Annotated Fig 12 below, capable of being positioned as described).
RE. Claim 18, the combination of Spence and Marquez discloses the invention substantially as claimed and as discussed above with respect to claim 16 teaches wherein there are only three outwardly-projecting bosses (Marquez Fig 18A, 1781) and three tethering sutures (Spence Col 9, lines 1-36, teaches a plurality of sutures).
RE. Claim 19, the combination of Spence and Marquez discloses the invention substantially as claimed and as discussed above with respect to claim 11, but does not disclose wherein the outwardly-projecting bosses each comprises a rounded rectangular projection through which a pair of identical apertures extend.
But in another embodiment Marquez discloses a similar annuloplasty implant. Marquez teaches wherein the outwardly-projecting bosses each comprises a rounded rectangular projection (Marquez Fig 25) through which a pair of identical apertures (Marquez Fig 16B, meets definition of apertures) extend (Marquez Fig 25, [0176]).
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 the outwardly-projecting bosses each comprises a rounded rectangular projection through which a pair of identical apertures extend, as taught and suggested by Marquez in order to secure other elements to the implant (Marquez [0143)].
Claim(s) 7 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spence in view of Marquez, and further in view of Zeitani et al. US 20200030096 A1, herein referred to as Zeitani.
RE. Claim 7, the combination of Spence and Marquez discloses the invention substantially as claimed and as discussed above with respect to claim 6 but does not disclose wherein there are only two outwardly-projecting bosses, one on each side of the minor axis and two tethering sutures.
Zeitani teaches wherein there are only two outwardly-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).
RE. Claim 17, the combination of Spence, Marquez, and Zeitani discloses the invention substantially as claimed and as discussed above with respect to claim 7 teaches wherein there are only two outwardly-projecting bosses (Fig 7Q, legs 120 [0088]) (capable being used as desired or placed for support), one on each side of the minor axis and two tethering sutures ([0125) capable of being used this way).
Claim(s) 11 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spence in view of Marquez, and further in view of Schweich et al. US 20130282110 A1, herein referred to as Schweich.
RE. Claim 11, the combination of Spence and Marquez discloses the invention substantially as claimed and as discussed above with respect to claim 12, but does not disclose wherein the at least one outwardly-projecting boss comprises a T-shaped projection having rounded ends.
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 the combination of Spence and Marquez to incorporate wherein the at least one outwardly-projecting boss comprises a T-shaped projection having rounded ends in order to allow robust engagement (Schweich abstract).
RE. Claim 20, the combination of Spence, Marquez, and Schweich discloses the invention substantially as claimed and as discussed above with respect to claim 12 teaches wherein the outwardly-projecting bosses each comprises a T-shaped projection having rounded ends (Fig 50, 302).
Conclusion
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, Melanie Tyson can be reached at (571) 272-9062. 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
/THOMAS C BARRETT/SPE, Art Unit 3799
Prosecution Insights