DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed 08/14/25 have been fully considered but they are not persuasive.
On page 7 regarding claim objections and 112 rejections, Applicant argues amendments overcome the outstanding issues.
The Examiner respectfully agrees and withdraws the objections and 112 rejections.
On page 8 regarding prior art rejections, Applicant argues Alfieri qualifies under prior art under pre-AIA 35 U.S.C. 102(a), and that due to common ownership, Alfieri is disqualified as prior art.
The Examiner respectfully disagrees, noting Alfieri is prior art under 35 U.S.C. 102(e). Further, a statement of common ownership at the time the invention was made would be required to overcome this rejection. The USPTO does not have record of the two inventions being commonly owned at the time the invention was made, making this insufficient to overcome the rejection of record. The rejection is accordingly maintained.
On page 9 regarding prior art rejections, Applicant argues the declaration made under 37 CFR 1.131 which states that provisional application 60/910192 shows the invention was invented at a date prior to Alfieri.
The Examiner respectfully disagrees, noting that while a declaration can be made by someone with power of attorney, the signature on the declaration does not include a registration number, making the declaration ineffective to overcome the prior art reference. The Examiner also notes no evidence of diligence between the filing of provision application 60/910192 on 04/04/2007 and the filing of the instant application on 05/13/2008. The rejection is accordingly maintained.
Special Definitions which are applied to the claims:
“asymmetric” = there are no planes of symmetry through the ring body looking from the inflow side ([0041])
“ovoid” = generally shaped like an egg with a long axis and a short axis, and one long end larger than the other ([0041])
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1 and 3-12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Alfieri et al. (US 20080275551 A1) hereinafter known as Alfieri in view of McCarthy (US 20060129236 A1).
Regarding claim 1, Alfieri discloses a prosthetic tricuspid annuloplasty ring ([0057] “conventional tricuspid ring 60”) adapted for implant at a tricuspid annulus formed by a peripheral annulus of a native tricuspid valve (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the patented structure of Alfieri was considered capable of performing the cited intended use of being implanted at the tricuspid annulus. See, for example Figure 8, which shows the dotted outline the conventional ring would occupy if implanted at the tricuspid annulus), the tricuspid annulus defining an asymmetric ovoid shape as seen looking at an inflow side (this is drawn towards a feature of a native body part as opposed to the ring. See also Annotated Figure 9) and circumscribes, clockwise: an antero-septal commissure, an anterior leaflet on an anterior side, an antero-posterior commissure, a posterior leaflet on a posterior side, a postero-septal commissure, and a septal leaflet on a septal side (this is drawn towards a feature of a native body part as opposed to the ring. See also Figure 5; [0024]-[0026]), the native valve having a long dimension extending from the antero-septal to postero-septal commissure with the septal leaflet extending therebetween (this is drawn towards a feature of a native body part as opposed to the ring. See also Figure 5), the septal leaflet being located inward of electrical structure of the heart including, clockwise: an AV node, a bundle of His, an apex of a triangle of Koch formed by the septal side, an ostium of the coronary sinus, and a tendon of Torado (this is drawn towards a feature of a native body part as opposed to the ring. See also Figure 6; [0026]), wherein the ring comprises:
a C-shaped inner ring body (Figure 9),
wherein the ring body has an asymmetric ovoid plan view shape that is entirely outwardly convex (Annotated Figure 9) and extends in the clockwise direction from a first free end (Figure 9, under item 42a ([0057])) around to a second free end as is seen looking at an inflow side thereof (Figure 9 item 68), the ring body being discontinuous so as to define the two free ends separated across a gap (Figures 5, 8, and Annotated Figure 9), the ring body having a length and shape such that when the first free end if implanted adjacent the antero-septal commissure the second end is located adjacent the septal leaflet (This appears to be related to the intended method of implanting as opposed to structurally limiting the ring itself (see the explanation above regarding “intended use” statements). See also Figures 5, 8), and wherein the inner ring body has three segments (Annotated Figure 9)
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Further, regarding claim 1 Alfieri further discloses an annuloplasty ring which is covered with an outer cover of a biocompatible fabric or biocompatible cloth ([0015]),
wherein the ring has a labeled ring size in mm representative to a dimension in mm across a long axis of the ring ([0052]) and corresponding to the long dimension of the annulus (see Figures 5 and 8 along with [0052]: the long dimension of the ring and long dimension of the annulus “correspond” to one another).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the prior art ring disclosed by Alfieri by having the ring 60 be covered with an outer cover of biocompatible fabric/cloth in order to create a suture-permeable anchoring margin for the ring, thus ensuring the ring can be securely sutured in place for treatment of a patient’s annulus.
Further, regarding claim 1 Alfieri is silent with regards to the labeled ring size being selected to match the dimension of the long axis of the ring,
as well as the three segments being interrupted by two hinge points that permit the segments on either side of the hinge points to flex or twist with respect to one another.
However, regarding claim 1 McCarthy teaches a heart valve wherein the labeled ring size is selected to match the long dimension of the ring (see the table in [0052]). Alfieri and McCarthy are involved in the same field of endeavor, namely tricuspid annuloplasty rings. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the ring of Alfieri by having the labeled ring size matching the long dimension of the ring such as is taught by McCarthy since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of a label that matches the dimension of the ring would have been obvious to allow a cardiologist to distinguish easily between ring sizes in a way that is sensical and accurate.
Further regarding claim 1 Alfieri teaches that annuloplasty ring segments can be interrupted by hinge points that permit segments on either side of the hinge points to flex or twist with respect to one another ([0049]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the ring of the Alfieri McCarthy Combination so that there are hinge points which enable flexing/twisting in order to allow the ring to more closely follow the shape of the native annulus when implanted and sutured thereto, thus accommodating different patient geometries while maintaining ring stiffness in the plane.
Regarding claims 3-4, the Alfieri McCarthy Combination teaches the ring of claim 1 substantially as is claimed,
wherein Alfieri further teaches hinge points are located across the plan view shape ([0049] the hinge points are “discrete”, indicating they are located across (e.g. throughout) the ring) so the ring can flex about the points generally in a plane (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of *** discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See, for example [0049]).
Regarding claim 9, the Alfieri McCarthy Combination teaches the ring of claim 4 substantially as is claimed,
wherein the Combination further teaches a mid-portion of the ring body in a segment between the hinge points is planar (Alfieri [0049] indicate the hinge points allow the core to flex “out of plane” indicating at least a (mid)portion of the ring body between the hinges is planar).
Regarding claim 5, the Alfieri McCarthy Combination teaches the ring of claim 1 substantially as is claimed,
wherein The Combination further teaches the ring body has a varying flexibility around the plan view shape (by nature of the hinge points).
Regarding claim 6, the Alfieri McCarthy Combination teaches the ring of claim 1 substantially as is claimed,
wherein Alfieri further teaches the ring body has two arcuate bulges extending toward the inflow side that rise up and down (Figure 7b item 52, 54) to accommodate anatomical bulges of the annulus (this is stated as an “intended use” of the bulges (see the explanation in the rejection to claim 1 above). See also [0054]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the Alfieri McCarthy Combination by having the ring 60’s include an arcuate bulge out of the plane as is taught by Alfieri in order to accommodate a contour of the tricuspid annulus caused by the external presence of the aorta, reduce stress on the implant, and reduce the change of dehiscence (Alfieri [0054]).
Regarding claim 7, the Alfieri McCarthy Combination teaches the ring of claim 6 substantially as is claimed,
wherein Alfieri further teaches one of the bulges is located in a first segment (Figure 7b item 54) to accommodate an anatomical bulge of an adjacent native aorta into the annulus when the first free end is implanted adjacent the antero-septal commissure of the annulus (this is stated as an “intended use”. See the explanation in the rejection to claim 1 above. See also [0054].).
Regarding claim 8, the Alfieri McCarthy Combination teaches the ring of claim 6 substantially as is claimed,
wherein Alfieri further teaches one of the bulges is located adjacent the second free end (Figure 7b item 54) to accommodate an anatomical bulge of the annulus adjacent the septal leaflet when the first free end is implanted adjacent the antero-septal commissure of the annulus (this is stated as an “intended use”. See the explanation in the rejection to claim 1 above. See also [0054].).
Regarding claim 12, the Alfieri McCarthy Combination teaches the ring of claim 1 substantially as is claimed,
wherein Alfieri further teaches the outer cover comprises silicone rubber ([0015] outer cover of both silicone and fabric) molded around the inner ring body with the biocompatible fabric/cloth encompassing the silicone rubber ([0047]).
Claim(s) 10-11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Alfieri and McCarthy as is applied above, further in view of Redmond et al. (US 20090036979 A1) hereinafter known as Redmond.
Regarding claim 10, the Alfieri McCarthy Combination teaches the ring of claim 1 substantially as is claimed,
but is silent with regards to the gap being between about 23-59% of the labeled ring size.
However, regarding claim 10 Redmond teaches a heart valve with a gap being between about 23-59% the labeled ring size ([0035] 0-100% the distance between the commissures). Alfieri and Redmond are involved in the same field of endeavor, namely tricuspid annuloplasty rings. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the ring of the Alfieri McCarthy Combination to have a gap sized to be about 23-59% of the size of the ring as is taught by Redmond in order to allow the surgeon to balance the desire to position the free ends of the ring to avoid conductive tissue, and to facilitate appropriate surgical attachment, and locate ring free ends at preferred locations ([0031], [0038]), while also ensuring proper support for anchoring the device to the annulus ([0038]). It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only ordinary skill in the art. See MPEP 2144.05(II)(A). Additionally, the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). Since the specific geometry of anatomy (and any possible abnormalities), pathology and disease state, and structural needs of each patient will vary from patient-to-patient, the specific gap distance being from 0-100% of the labeled ring size (including 23-59%) would have been obvious to the person of ordinary skill at the time the invention was made.
Regarding claim 11, the Alfieri McCarthy Redmond Combination teaches the ring of claim 10 substantially as is claimed,
wherein the Combination further teaches the gap is between about 10-18 mm (Redmond [0035] teaches a ring gap can be 0-100% the distance between the commissures, and Alfieri teaches their ring can be between 26-36 mm ([0052]). A gap 0-100% of 26-36 mm is understood to fall within a 10-18 mm range.)
Claim(s) 2 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Alfieri and McCarthy as is applied above, further in view of Milo (WO 2009090564 A2).
Regarding claim 2, the Alfieri McCarthy Combination teaches the ring of claim 1 substantially as is claimed,
but is silent with regards to the location of the hinge points.
However, regarding claim 2 Milo teaches annuloplasty hinge points can be located generally diametrically opposed across the plan view shape (Figures 19, 22). Alfieri and Milo are involved in the same field of endeavor, namely annuloplasty rings. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the location of the hinge points so they are diametrically opposite one another as is taught by Milo in order to allow bidirectional movement to shorten the ring at either location, which allows a surgeon to make adjustments to dimensions of the ring after its initial securing and thus adjusting the diameter of the valve being repaired (Milo Abstract).
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 extension fee 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 08/25/25