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(s) 1 is/are objected to because of the following informalities:
Within claim 1, line 2: “a prosthetic valve” should be replaced with --the prosthetic valve-- (in order to properly link back with the prosthetic valve from claim 1, line 1);
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 6, 12, 14-20 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Within claim 6, line(s) 1-2: Applicant claims, “wherein the first portion and the second portion are configured to interface between a sewing cuff and the frame of the prosthetic valve”; it is unclear, and therefore indefinite, what is meant by the first and second portions are configured to interface between the cuff and the frame”; if “interface” is meant to mean meet/ connect then the first and second portions don’t appear to “interface” between (as in the middle) the cuff and the frame. Instead it appears the first and second portions appear to connect at the “interface” of the cuff and the frame. Additionally, paragraph [0109] describes the jacket as a whole (not both the first and second portions) being configured to be an interface between the cuff and the frame.
Within claim 12, lines 1-2: Applicant claims, “tips of the first portion”; it is unclear, and therefore indefinite, how many tips are required of the first portion – within the aforementioned claim requirement tips is plural (i.e. there must be at least two), however, within claim 1 (from which claim 12 depends) there maybe only one (due to the “one or more” claim language).
Within claim 14, lines 1-5: Applicant clams, “a prosthetic valve comprising: […] a first portion configured to couple to an outflow side of the prosthetic valve”; it is unclear, and therefore indefinite, how the prosthetic valve can comprise (i.e. include) a structure (specifically the first portion) while also being configured to couple to the structure (specifically the outflow side of the prosthetic valve). Additionally, it is unclear and therefore indefinite, if Applicant is intending to claim the finished/ assembled prosthetic valve OR merely the components thereof due to the “configured to” language – does the prosthetic valve need to include the first portion coupled to OR merely configured to (capable) of being coupled to? For the purposes of examination, Examiner is assuming the aforementioned claim requirement should be rewritten as --a prosthetic valve comprising: […] a first portion coupled to an outflow side of the one or more leaflets--. Claim(s) 15-20, which depend from claim 14, inherit all the problems associated with claim 14.
Within claim 14, lines 1-8: Applicant clams, “a prosthetic valve comprising: […] a second portion configured to couple to an inflow side of the prosthetic valve”; it is unclear, and therefore indefinite, how the prosthetic valve can comprise (i.e. include) a structure (specifically the second portion) while also being configured to couple to the structure (specifically the inflow side of the prosthetic valve). Additionally, it is unclear and therefore indefinite, if Applicant is intending to claim the finished/ assembled prosthetic valve OR merely the components thereof due to the “configured to” language – does the prosthetic valve need to include the second portion coupled to OR merely configured to (capable) of being coupled to? For the purposes of examination, Examiner is assuming the aforementioned claim requirement should be rewritten as --a prosthetic valve comprising: […] a second portion coupled to an inflow side of the one or more leaflets--.
Within claim 14, lines 1-12: Applicant clams, “a prosthetic valve comprising: […] a second portion […] wherein the one or more second tips are configured to coupled to the one or more first tips to at least partially cover posts of the prosthetic valve”; it is unclear, and therefore indefinite, how the prosthetic valve can comprise (i.e. include) a structure (specifically the second portion) while also being configured to couple to the structure (specifically the posts of the prosthetic valve). Additionally, it is unclear and therefore indefinite, if Applicant is intending to claim the finished/ assembled prosthetic valve OR merely the components thereof due to the “configured to” language – does the prosthetic valve need to include the first and second tips coupled to at least partially cover the posts OR merely configured to (capable) of being coupled to? For the purposes of examination, Examiner is assuming the aforementioned claim requirement should be rewritten as --a prosthetic valve comprising: […] a second portion […] wherein the one or more second tips are coupled to the one or more first tips to at least partially cover posts of the frame--.
Within claim 15, lines 1-2: Applicant claims, “the one or more first tips and one or more second tips are configured to the secured together”; it is unclear, and therefore indefinite, if Applicant is intending to claim the finished/ assembled prosthetic valve OR merely the components thereof due to the “configured to” language – does the prosthetic valve need to include the first and second tips secured together OR merely configured to (capable) of being secured together?
Within claim 18, lines 1-2: Applicant claims, “first portion and the second portion are configured to the secured together”; it is unclear, and therefore indefinite, if Applicant is intending to claim the finished/ assembled prosthetic valve OR merely the components thereof due to the “configured to” language – does the prosthetic valve need to include the first and second portions secured together OR merely configured to (capable) of being secured together?
Within claim 19, lines 1-2: Applicant claims, “first portion and the second portion are configured to interface together”; it is unclear, and therefore indefinite, if Applicant is intending to claim the finished/ assembled prosthetic valve OR merely the components thereof due to the “configured to” language – does the prosthetic valve need to include the first and second portions interfaced together OR merely configured to (capable) of being interfaced together?
Within claim 19, line(s) 1-2: Applicant claims, “wherein the first portion and the second portion are configured to interface between a sewing cuff and the frame of the prosthetic valve”; it is unclear, and therefore indefinite, what is meant by the first and second portions are configured to interface between the cuff and the frame”; if “interface” is meant to mean meet/ connect then the first and second portions don’t appear to “interface” between (as in the middle) the cuff and the frame. Instead it appears the first and second portions appear to connect at the “interface” of the cuff and the frame. Additionally, paragraph [0109] describes the jacket as a whole (not both the first and second portions) being configured to be an interface between the cuff and the frame.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-5, 7-9, 11-15, 17-18, 20 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Lane et al. (US 6334873 B1).
With respect to claim 1:
Lane et al. discloses a covering for a prosthetic valve, the covering comprising:
a first portion (elastomeric sheath 42), as can be seen in figs. 9A-11B, configured to couple to an outflow side of a prosthetic valve (leaflets 50), the first portion (elastomeric sheath 42) being annular in shape and having a first edge (defined by a top surface of the sheath pocket 84, as seen in fig. 11B) alternating between one or more first tips (sheath commissure posts 46) and one or more first valleys (sheath scalloped walls 48) (column 5, line 66-column 6, line 44); and
a second portion (in combination inner frame 10 and anchors 34, 36), as can be seen in figs. 2-6, configured to couple to an inflow side of the prosthetic valve (leaflets 50), the second portion (inner frame and anchors 34, 36) being annular in shape and having a second edge (top most surface of) alternating between one or more second tips (commissure posts 14) and one or more second valleys (scalloped walls 16) (column 3, lines 36-50 and column 4, lines 20-39), wherein the one or more second tips (commissure posts 14) are configured to couple to the one or more first tips (sheath commissure posts 46) to at least partially cover posts (commissure posts 14a of outer frame 24) of the prosthetic valve, as can be seen in fig. 11B, and wherein the one or more second tips (commissure posts 14) have a tapered form (tapering in the circumferential direction toward the free tip of commissure posts 14).
With respect to claim 2:
Wherein the one or more first tips (sheath commissure posts 46) and the one or more second tips (commissure posts 14) are configured to be secured together by at least one of a swaging, a snap fit, a click fit (as Applicant has not defined what a “click fit” connection is, as such Examiner is considering the stretching of the commissure posts 46 of the elastomeric sheath 42 over the commissure posts 14 of the inner frame 10 and anchors 34, 36 such that the anchors 34, 36 will have to “click fit” (fit into) the holes 64) (column 6, lines 10-38), one or more staples, tape (Examiner is considering the dacron covering which surrounds the commissure posts 46 of the elastomeric sheath 42 and the commissure posts 14 of the inner frame 10 and anchors 34, 36 to be a tape which is secured to itself at thermal weld point 110) (column 6, lines 39-45), adhesives, one or more screws, one or more rivets, insert molding, or overmolding.
With respect to claim 4:
Wherein the first portion (elastomeric sheath 42) comprises three first tips (sheath commissure posts 46) (column 3, lines 13-32).
With respect to claim 5:
Wherein the first portion (elastomeric sheath 42) and the second portion (inner frame and anchors 34, 36) are configured to be secured together about a frame (outer frame 24) of the prosthetic valve (column 3, line 58-column 4, line 19).
With respect to claim 7:
Wherein the one or more first tips (sheath commissure posts 46) are atraumatic (are not sharp and are not configured to puncture tissue).
With respect to claim 8:
Wherein the one or more first tips (sheath commissure posts 46) include first interfaces (holes 64) and the one or more second tips (commissure posts 14) include second interfaces (anchors 34), the first and second interfaces (holes 64 and anchor 34) being configured to join the first and second portions (elastomeric sheath 42, inner frame 10 and anchors 34, 36) together (column 6, lines 10-38).
With respect to claim 9:
Wherein the first interfaces (holes 64) and the second interfaces (anchors 34) are operable to snap together (Examiner is considering the stretching of the commissure posts 46 of the elastomeric sheath 42 over the commissure posts 14 of the inner frame 10 and anchors 34, 36 such that the anchors 34, 36 will have to “snap together” (into) the holes 64) (column 6, lines 10-38) to join the first portion (elastomeric sheath 42) to the second portion (inner frame and anchors 34, 36).
With respect to claim 11:
Wherein the first portion (elastomeric sheath 42 IN COMBINATION with sewing ring 70) includes a flange element (sewing ring 70) projecting at least partially radially outward (as can be seen in fig. 11B, after assembly, the sewing ring 70 is permanently connected to the elastomeric sheath 42 and as such can be considered a portion of the “first portion” as claimed; in which case the sewing ring maybe considered a flange extending radially outward from the rest of the elastomeric sheath) (column 6, line 47-column 7, line 15).
With respect to claim 12:
Wherein the flange element (sewing ring 70) extends between (is between in a circumferential direction) tips (sheath commissure posts 46) of the first portion (elastomeric sheath 42 IN COMBINATION with sewing ring 70), as can be seen in figs. 1 and 11A-11C.
With respect to claim 13:
Wherein the first portion (elastomeric sheath 42) is formed of a more flexible material (silicone rubber) (column 5, line 66-column 6, line 9) relative to a material (metal such as elgiloy) of the second portion (inner frame and anchors 34, 36) (column 3, lines 51-57).
With respect to claim 14:
Lane et al. discloses a prosthetic valve (heart valve 9), as can be seen in fig. 1, comprising:
a frame (outer frame 24) (column 3, line 58-column 4, line 6);
one or more leaflets (leaflets 50) attached to the frame (outer frame 24), as can be seen in fig. 8 (column 5, lines 42-64); and
a covering comprising:
a first portion (elastomeric sheath 42), as can be seen in figs. 9A-11B, coupled to an outflow side of the one or more leaflets (leaflets 50), the first portion (elastomeric sheath 42) being annular in shape and having a first edge (defined by a top surface of the sheath pocket 84, as seen in fig. 11B) alternating between one or more first tips (sheath commissure posts 46) and one or more first valleys (sheath scalloped walls 48) (column 5, line 66-column 6, line 44); and
a second portion (in combination inner frame 10 and anchors 34, 36), as can be seen in figs. 2-6, coupled to an inflow side of one or more leaflets (leaflets 50), the second portion (inner frame and anchors 34, 36) being annular in shape and having a second edge (top most surface of) alternating between one or more second tips (commissure posts 14) and one or more second valleys (scalloped walls 16) (column 3, lines 36-50 and column 4, lines 20-39), wherein the one or more second tips (commissure posts 14) are configured to couple to the one or more first tips (sheath commissure posts 46) to at least partially cover posts (commissure posts 14a of outer frame 24) of the prosthetic valve, as can be seen in fig. 11B, and wherein the one or more second tips (commissure posts 14) have a tapered form (tapering in the circumferential direction toward the free tip of commissure posts 14).
With respect to claim 15:
Wherein the one or more first tips (sheath commissure posts 46) and the one or more second tips (commissure posts 14) are secured together by at least one of a swaging, a snap fit, a click fit (as Applicant has not defined what a “click fit” connection is, as such Examiner is considering the stretching of the commissure posts 46 of the elastomeric sheath 42 over the commissure posts 14 of the inner frame 10 and anchors 34, 36 such that the anchors 34, 36 will have to “click fit” (fit into) the holes 64) (column 6, lines 10-38), one or more staples, tape (Examiner is considering the dacron covering which surrounds the commissure posts 46 of the elastomeric sheath 42 and the commissure posts 14 of the inner frame 10 and anchors 34, 36 to be a tape which is secured to itself at thermal weld point 110) (column 6, lines 39-45), adhesives, one or more screws, one or more rivets, insert molding, or overmolding.
With respect to claim 17:
Wherein the first portion (elastomeric sheath 42) comprises three first tips (sheath commissure posts 46) (column 3, lines 13-32).
With respect to claim 18:
Wherein the first portion (elastomeric sheath 42) and the second portion (inner frame and anchors 34, 36) are secured together about a frame (outer frame 24) of the prosthetic valve (column 3, line 58-column 4, line 19).
With respect to claim 20:
Wherein the one or more first tips (sheath commissure posts 46) are atraumatic (are not sharp and are not configured to puncture tissue).
Allowable Subject Matter
Claim(s) 3, 6, 10 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim(s) 16, 19 is/are would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Examiner can find no references alone nor in combination which render obvious:
With respect to claim(s) 3, 16:
A covering/ prosthetic valve (as required by claim(s) 1 or 14) wherein the one or more second tips increase in width towards the free ends thereof (as required by claim(s) 3 or 16 respectively).
With respect to claim 10:
A covering/ prosthetic valve (as required by claim(s) 1 or 14) wherein the first portion includes a fillet (wherein the filet is operable/ intended to limit tissue ingrowth beyond/ at the boundary created by the fillet).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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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.
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/REBECCA S PRESTON/ Examiner, Art Unit 3774