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 drawing objections/claim objections/112b rejections have been considered persuasive, current drawings/claim objections/112b rejections of record have been withdrawn.
Applicant’s arguments with regards to the 102 and 103 rejections under Mayberry and combinations thereof were not found to be persuasive.
Applicant’s arguments rely on language solely recited in preamble recitations in claim 1. When reading the preamble in the context of the entire claim, the recitation “aortic root replacement graft” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Additionally, the term “aortic root replacement graft” is directed towards an intended use of the device, which is not given patentable weight. The prior art is not required to disclose the same intended use of the prosthesis being placed at an aortic root, but merely have the capability of being used in this manner. In this case, the Mayberry prosthesis is configured for implantation with an aorta and is capable of being placed at an aortic root.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “open surgery,” “cut ends or an aorta,” or “open heart surgery”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that the references fail to show certain features of the invention, (i.e., “downward direction” in claim 3), the examiner disagrees. As stated in the rejection, paragraph ([0157] states that arms are adjustable and can be moved axially or angularly to fit patient anatomy, therefore this adjustment includes a downwards direction. Therefore, the capability of the arms to be positioned downward at least some degree relative to the horizontal plane traversing the bulged portion meets this claim requirement.
In response to applicant's argument that the references fail to show a reinforcing sleeve that is engaged with an exterior surface, examiner disagrees, see figure 62a. It is further noted that the features upon which applicant relies (i.e., does not “include gaps”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In regards to claim 6: In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., markers that “aid in identification during insertion into a patient”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The markers taught by O’Donnell perform the function of identification of locations around the circumference of the prosthesis and meet the broad requirement of “markers.”
Regarding claim 7: In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “seen by the naked eye”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Applicant also argues that a hole taught by Vyas would make the device ineffective, however Vyas is only relied upon for modifying the specific marker orientation of Mayberry. The holes of Vyas are not incorporated into the Mayberry device.
In response to applicant's argument that the references fail to show certain features of the invention in claims 8-9, see argument 1 above.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “Valsalva sinuses”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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) 1-5, and 14-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mayberry (WO 2010127040 A1).
Regarding claim 1, Mayberry teaches an aortic root replacement graft ([0015]), comprising: a tubular portion; a bulged portion with a first end and a second end, wherein the second end of the bulged portion is coupled to a first end of the tubular portion; a cuff portion coupled to the first end of the bulged portion (see figures, for example annotated figure 11); and at least one side arm coupled to and extending from the bulged portion ([0016], for example see fig 10).
Annotated Figure 11
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Regarding claim 2, Mayberry further teaches wherein the at least one side arm is a first side arm and a second side arm ([0016]).
Regarding claim 3, Mayberry further teaches wherein the first side arm and second side arm are disposed in a downward direction relative to a horizontal plane traversing the bulged portion of the graft ([0157], arms are adjustable and can be moved axially or angularly to fit patient anatomy, this includes downwards).
Regarding claim 4, Mayberry further teaches wherein the first side arm and the second side arm are flexible, and wherein the first side an and the second side arm are bendable at least one of an upwards direction, a downwards direction, left and right directions in a cross-sectional plane of the first side an and the second side arm ([0157], arms are adjustable and can be moved axially or angularly to fit patient anatomy).
Regarding claim 5, Mayberry further teaches the first side arm and the second side arm further comprise: at least one marker ([0029]) positioned between a first end and a second end of each of the first side arm and the second side arm ([0029], if the marker is on the side branch it would inherently be between the ends of the branches).
Regarding claim 14, Mayberry further teaches a reinforcing sleeve positioned to engage an exterior surface of a second end of the tubular portion (see fig 62a, graft covering materials engages with outer surface of tubular stent portion below bulge, note in [0331] embodiment features are combinable).
Regarding claim 15, Mayberry further teaches wherein the reinforcing sleeve is a straight tube (graft cover material is straight and tubular, see fig 62a) with an internal surface (see fig 62a, inherently has inner surface) having a first diameter (see fig 62a, inherently has diameter) and an exterior surface of the tubular portion (see fig 62a, tubular strut potion has outer surface) having a second diameter (see fig 62a, inherently has diameter), wherein the first diameter is larger than the second diameter (reinforcing graft material is on top of tubular strut potion, the sleeve diameter therefore is greater).
Regarding claim 16, Mayberry further teaches wherein the reinforcing sleeve includes a proximal portion with a first radius and a distal portion with a second radius, and wherein the first radius is different than the second radius (the graft material sleeve has a top and bottom end, or a proximal and distal end, see fig 62a, the width/radius of these ends are different).
Regarding claim 17, Mayberry further teaches wherein the reinforcing sleeve comprises: at least one encircling ligature (see fig 62a, stitching 1208).
Regarding claim 18, Mayberry further teaches wherein the at least one encircling ligature is a first ligature and a second ligature (see fig 62a, stitching 1208, top and bottom), and wherein the first ligature is disposed on an end of the reinforcing sleeve with a larger radius (the first stitching is disposed on the top the width/radius of the top is larger).
Regarding claim 19, Mayberry further teaches wherein the at least one encircling ligature is a first ligature and a second ligature (see fig 62a, stitching 1208, top and bottom), and wherein the second ligature is disposed on an end of the reinforcing sleeve with a smaller radius (the second stitching is disposed on the bottom the width/radius of the top/bottom is smaller).
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(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Mayberry (WO 2010127040 A1) in view of O’Donnell (GB 2517689).
Regarding claim 6, Mayberry teaches a graft with stent side branches and markers but does not exactly teach the marker orientation. O’Donnell however teaches a tubular stent graft (abstract) wherein the at least one marker is a plurality of markers (pg. 11, lines 13-16) dividing the circumference of each of the first side arm and the second side arm into quadrants (pg. 11, lines 13-16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stent side branch as taught by Mayberry by including the marker orientation, as taught by O’Donnell, in order to indicate equidistance measurements along the circumference of the device (pg. 11, lines 13-16).
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Mayberry (WO 2010127040 A1) in view of Vyas (US 20170203010 A1).
Regarding claim 7, Mayberry teaches a graft with stent side branches and markers but does not exactly teach the claimed marker orientation. Vyas however teaches a stent (abstract) wherein the at least one marker is a plurality of markers ([0111]) dividing the circumference of each of the first side arm and the second side arm into thirds ([0111]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stent branch taught by Mayberry by including the marker orientation, as taught by Vyas, in order to clearly depict the shape and positioning of the device ([0111]).
Claim(s) 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Mayberry (WO 2010127040 A1) in view of Fann (WO 2014145811 A1).
Regarding claim 8, Mayberry does not exactly teach wherein the graft device includes a heart valve. Fann however teaches an aortic graft (abstract) wherein the graft contains a heart valve prosthesis coupled to an end of the graft positioned at or below the bulged portion (see fig 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Mayberry by including the heart valve, as taught by Fann, in order to safely facilitate replacement of a patients diseased/damaged valve [0008]
Regarding claim 9, Mayberry does not exactly teach wherein the graft device includes a heart valve. Fann however teaches an aortic graft (abstract) wherein the heart valve prosthesis is selected from at least one of a mechanical prosthesis and a biological prosthesis (see fig 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Mayberry by including the heart valve, as taught by Fann, in order to safely facilitate replacement of a patients diseased/damaged valve [0008]
Claim(s) 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Mayberry (WO 2010127040 A1) in view of Calcaterra (“Aortic Root Reconstruction with a New Dacron Graft Featuring Prefabricated Coronary Side Branches”).
Regarding claims 10 -13, Mayberry fails to teach a venting chimney. Calcaterra however teaches an aortic graft (abstract) wherein the graft has a venting chimney (figure 1,) coupled to and extending from an exterior surface of the graft (see fig 1, side port branch 2, page 3, paragraph 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Mayberry by including the venting chimney, as taught by Calcaterra, in order to de-air the graft after reconstructing (page 3, paragraph 1).
Regarding claim 11, Calcaterra further teaches the venting chimney is disposed perpendicular to a long axis of the graft (see fig 1, side branch is perpendicular). It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to orient the venting chimney of modified Mayberry to be perpendicular to the graft, as taught by Calcaterra.
Regarding claim 12, Calcaterra further teaches the venting chimney is coupled to and extending from the tubular portion of the graft (see fig 1, side branch is on tubular graft construction). Therefore, it would have been obvious to provide a chimney of modified Mayberry in this manner.
Regarding claim 13, Calcaterra further teaches the venting chimney, the first arm, and the second arm are each radial offset around the tubular portion of the graft (see fig 1, the three branches are radially offset). Therefore, it would have been obvious to arrange the components of modified Mayberry in this manner.
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 8:30PM-4:30PM EST M-F (occasionally off Fridays).
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/H.L.P./Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774