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 19 is objected to because of the following informalities: there should be a period at the end of the claim. 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 18 is 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.
Claim 18 recites the limitation "respective sets of the plurality of sets" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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, 3, and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Glazier US 2011/0301703.
Regarding claims 1 and 3, Glazier discloses an assembly comprising: a prosthetic valve 200 comprising a radially expandable and compressible annular frame (figure 4, paragraph 0039), the frame having an outer surface and an inner surface (inner and outer surface of frame 202, figure 4), and a leaflet assembly supported inside the annular frame (paragraph 0040, cuff/leaflet assembly), the leaflet assembly comprising a plurality of leaflets, each leaflet having an inner surface and an outer surface (inner and outer surface of plurality of leaflets, not shown, paragraph 0040); and a crimping accessory device 100 comprising a shaft and a plurality of fingers 108 extending from the shaft (figure 4), wherein at least a first finger of the plurality of fingers has a first length and at least a second finger of the plurality of fingers has a second length (length of fingers 108), the second length being longer than the first length (paragraph 0031, tines 108 may differ in length), the fingers may be placed between the valve structure and the stent frame (paragraphs 0014, 0016), wherein one finger of the plurality of fingers is disposed between the outer surface of a leaflet of the plurality of leaflets and the annular frame (paragraphs 0014, 0016, plurality of tines may be positioned between the valve structure and the stent frame).
Regarding claim 6, Glazier discloses wherein the crimping accessory device comprises a plurality of sets of two or more fingers formed from fingers of the plurality of fingers (paragraph 0030, number of times may be as few as two tines or more than sixteen, each two times may be considered a set), each set of the plurality of sets including a finger of the plurality of fingers that has the first length and a finger of the plurality of fingers that has the second length (paragraph 0031, one or more of the tines may be shorter or longer than the others, therefore, two tines may be considered a set of tines, the set may be a different length).
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) 7, 8, 10, 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glazier US 2011/0301703.
Regarding claim 7, Glazier discloses wherein fingers are disposed against a respective leaflet of the plurality of leaflets (paragraphs 0014, 0016, plurality of tines may be positioned between the valve structure and the stent frame), each set of the plurality of sets including a finger of the plurality of fingers that has the first length and a finger of the plurality of fingers that has the second length (paragraph 0031, one or more of the tines may be shorter or longer than the others, therefore, two tines may be considered a set of tines, the set may be a different length), but fails to explicitly disclose wherein fingers of a given set of fingers are disposed against a respective leaflet of the plurality of leaflets. However, it would have been obvious to one having ordinary skill in the art to provide a tine or set of tines having the desired length for engaging with the valvular structure or particular leaflet, as there is a finite number of identified, predictable solutions including the set of tines of a particular length being adjacent the same or different leaflets or the same or different lengths as necessary with a reasonable expectation of success.
Regarding claims 8 and 13, Glazier an assembly comprising: a prosthetic valve comprising a radially expandable and compressible annular frame (figure 4, paragraph 0039), the frame having an outer surface and an inner surface (inner and outer surface of frame 202, figure 4), and a leaflet assembly supported inside the annular frame (paragraph 0040, cuff/leaflet assembly), the leaflet assembly comprising a plurality of leaflets, each leaflet having an inner surface and an outer surface (inner and outer surface of plurality of leaflets, not shown, paragraph 0040); and a crimping accessory device 100 comprising a shaft and a plurality of fingers extending from the shaft (figure 4), and the fingers of the plurality of fingers being disposed either against the inner surface or the outer surface of a leaflet of the plurality of leaflets, the fingers may be placed between the valve structure and the stent frame (paragraphs 0014, 0016), wherein one finger of the plurality of fingers is disposed between the outer surface of a leaflet of the plurality of leaflets and the annular frame (paragraphs 0014, 0016, plurality of tines may be positioned between the valve structure and the stent frame), wherein at least a first finger of the plurality of fingers extends from the shaft at a first angle and at least a second finger of the plurality of fingers extends from the shaft at a second angle (figure 4), wherein the crimping accessory device comprises a plurality of sets of two or more fingers of the plurality of fingers (paragraph 0030, number of times may be as few as two tines or more than sixteen, each two times may be considered a set), each set of the plurality of sets including a finger of the plurality of fingers that has the first angle and a finger of the plurality of fingers that has the second angle (paragraph 0032, first and second angle of portion 116), but fails to explicitly disclose the second angle being less than the first angle.
Glazier discloses tines 108 defining an annular array having a substantially cylindrical configuration around central axis 110 (figure 4), or other configurations including, but not limited to, oval and elliptical configurations (paragraph 0029), the angle between the second portions 116 and central axis 110 is not critical (paragraph 0032). The combination of that angle and the length of second portions 116 must be sufficient that, with tines 108 in the expanded state the cross-section defined by the first portions 112 of the tines is large enough to assemble the tines to a prosthetic heart valve (paragraph 0032). Examiner notes forming an oval or other non-circular configuration may result in forming various angles for portions 116 extending from the stem or shaft 102.
Therefore, it would have been an obvious matter of design choice to modify Glazier with at least a second finger of the plurality of fingers extends from the shaft at a second angle, the second angle being less than the first angle, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 10, Glazier discloses wherein one finger of the plurality of fingers is disposed between the outer surface of a leaflet of the plurality of leaflets and the annular frame (paragraphs 0014, 0016, plurality of tines may be positioned between the valve structure and the stent frame).
Regarding claim 14, Glazier discloses wherein a plurality of fingers are disposed against a respective leaflet of the plurality of leaflets (paragraphs 0014, 0016, plurality of tines may be positioned between the valve structure and the stent frame), but fails to explicitly disclose wherein fingers of a given set of fingers are disposed against a respective leaflet of the plurality of leaflets. However, it would have been obvious to one having ordinary skill in the art to provide a tine or set of tines having the desired length for engaging with the valvular structure or particular leaflet, as there is a finite number of identified, predictable solutions including the set of tines of a particular length being adjacent the same or different leaflets or the same or different lengths as necessary with a reasonable expectation of success.
Claim(s) 2, 4, 5, 9, 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glazier US 2011/0301703 in view of Benichou et al. US 2008/0154355.
Regarding claims 2, 4, 5, 9, 11 and 12, Glazier discloses a plurality of fingers, one of the finger of the plurality of fingers is disposed between the outer surface of the leaflet and the annular frame (paragraphs 0014, 0016, plurality of tines may be positioned between the valve structure and the stent frame), but fails to explicitly disclose the one finger of the plurality of fingers is disposed against the inner surface of a leaflet of the plurality of leaflets, wherein one finger of the plurality of fingers is disposed against the inner surface of a leaflet of the plurality of leaflets and another finger of the plurality of fingers is disposed between the outer surface of the leaflet and the annular frame, the one finger is the at least a first finger and the another finger is the at least a second finger.
Benichou et al. teaches a prosthetic valve comprising a radially expandable and compressible annular frame 104 (paragraph 0014) and a leaflet assembly 102 (paragraph 0040) mounted inside of the annular frame (figure 2), and a crimping device 200, a plurality of fingers of the crimping device (figure 9, fingers 204, 206), the one finger of the plurality of fingers 204 is disposed against the inner surface of a leaflet of the plurality of leaflets (figure 8) and another finger of the plurality of fingers 206 is disposed between the outer surface of the leaflet and the annular frame (figure 8), the one finger is the at least a first finger 204 (figure 8) and the another finger is the at least a second finger (figure 8, finger 206), the number of fingers may vary (paragraph 0049), the fingers configured to easily form substantially equal and symmetrical folds 210 in the valve member 102 (paragraph 0051).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Glazier with the one finger of the plurality of fingers is disposed against the inner surface of a leaflet of the plurality of leaflets, wherein one finger of the plurality of fingers is disposed against the inner surface of a leaflet of the plurality of leaflets and another finger of the plurality of fingers is disposed between the outer surface of the leaflet and the annular frame, the one finger is the at least a first finger and the another finger is the at least a second finger, as taught by Benichou et al., as known in the art to easily form substantially equal and symmetrical folds in the valve member.
Claim(s) 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glazier US 2011/0301703 in view of Spenser et al. US 7,530,253.
Regarding claim 15, Glazier discloses a method for compressing a prosthetic valve 200, the prosthetic valve comprising a radially expandable and compressible annular frame (figure 4, paragraph 0039) and a leaflet assembly mounted inside of the annular frame (paragraph 0040, cuff/leaflet assembly), in cooperation with a crimping accessory device 100 (figure 4), the method comprising: inserting respective fingers of a plurality of fingers 108 of the crimping accessory device against either an inner surface or an outer surface of a respective valve leaflet of a plurality of valve leaflets (paragraphs 0014, 0016, plurality of tines may be positioned between the valve structure and the stent frame), placing the prosthetic valve with the inserted crimping accessory device in a crimping aperture 228 of funnel 228 of a crimping device (figure 6, paragraph 0046), at least partially crimping the prosthetic valve (paragraph 0046); and removing the crimping accessory device from the prosthetic valve after at least partially crimping the prosthetic valve using the crimping device (paragraph 0047, removing the crimping tool from the heart valve once placed in delivery catheter).
Glazier discloses a variety of different crimping devices other than funnel 226 may be used (paragraph 0050), but fails to explicitly disclose the crimping aperture of the crimping device formed by a plurality of circumferentially-arranged jaws of the crimping device.
Spenser et al. discloses a crimping device (figure 1) for compressing a prosthetic valve (column 1, lines 13-16), placing the prosthetic valve with the inserted crimping accessory device in a crimping aperture of a crimping device, the crimping aperture (column 6, lines 62-65; variable sized aperture) of the crimping device formed by a plurality of circumferentially-arranged jaws of the crimping device to compress the prosthetic valve (figure 1, twelve jaws 1 arranged around axis 10).
Therefore, it would have been obvious to one having ordinary skill in the art to provide a crimping device, as taught by Spenser et al., as known in the art as a known substitute for a crimping device to compress a prosthetic valve.
Regarding claim 16, Glazier discloses wherein the crimping accessory device 100 comprises a shaft 102 and the fingers of the plurality of fingers 108 extend from the shaft (figure 4).
Regarding claim 17, Glazier discloses wherein the crimping accessory device 100 comprises a plurality of sets of two or more fingers of the plurality of fingers (paragraph 0030, number of times may be as few as two tines or more than sixteen, each two times may be considered a set), respective sets of the plurality of sets corresponding to a leaflet of the prosthetic valve (paragraphs 0014, 0016, plurality of tines may be positioned between the valve structure and the stent frame, the tines placed around the valvular structure at least two or more fingers may correspond to a particular leaflet).
Regarding claim 18, Glazier discloses wherein the respective sets of the plurality of sets are circumferentially spaced apart from another (figure 4, paragraph 0029, any set of two tines 108 may be considered a set, tines 108 are circumferentially spaced).
Regarding claim 19, Glazier further comprises: securing the crimping accessory device to the prosthetic valve prior to crimping or radially compressing the prosthetic valve (figures 5, 6, paragraph 0045); and releasing the crimping accessory device from the prosthetic valve after crimping or radially compressing the prosthetic valve (paragraph 0047, removing or releasing the crimping tool from the heart valve once placed in delivery catheter).
Regarding claim 20, Glazier discloses wherein at least two fingers of the plurality of fingers differ in length or an angle at which they extend from a shaft of the crimping accessory device (paragraph 0031, tines 108 may differ in length).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771