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 .
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.
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) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lattouf (US 2004/0116963) in further in view of Durando (US 2016/0051246).
Regarding claim 1, Lattouf discloses a surgical method for attaching an artificial heart valve to a native valve annulus (see [0010]) disclosing heart valve replacement surgery by attaching the replacement valve to heart tissue), the surgical method comprising: obtaining a first set of sutures (112, 114), wherein each suture from the first set of sutures has a surgical thread with two ends (111, Fig. 3), a first needle (110) secured to the first end of the thread, a second needle (110) attached to the second end of the thread, and a pledget (116), the thread having a first distinguishing feature (see [0039] disclosing sutures of different colors ); obtaining a second set of sutures (112, 114), wherein each suture from the second set of sutures has a surgical thread with two ends (111, Fig. 3), a first needle (110) secured to the first end of the thread, a second needle (110) attached to the second end of the thread, and a pledget (116), the thread having a second distinguishing feature (see [0039] disclosing sutures of different colors); attaching a suture (112 or 114) from the first set of sutures to the native valve annulus by passing the first and second needles of the suture through the native valve annulus then passing the first and second needles through a sewing ring of the artificial valve (see Fig. 8 and [0046]); attaching a suture (112 or 114) from the second set of sutures to the native valve annulus adjacent the suture from the first set of sutures by passing the first and second needles of the suture through the native valve annulus then passing the first and second needles through the sewing ring of the artificial valve (see Fig. 8 and [0046]); repeating both the attaching steps with alternating sutures from the first and second sets of sutures such that adjacently positioned sutures are not from the same set of sutures (see Fig. 8); after all of the sutures are placed, tightening the ends (111) of the sutures to firmly seat the pledgets (116) against the native valve annulus (see [0048]); and tying the ends (111) of the tightened sutures (see [0047] and [0048] disclosing steps for placing all sutures , tightening them and tying the ends (111) of the sutures ). Lattouf fails to disclose the pledget (116) itself must share the distinguishing feature with its corresponding suture thread within the same set.
Durando also discloses a non-sliding, soft anchor (104) suture construct for automatic, friction-based locking of a suture. Durando teaches the first portion (116) and a second portion (124) of the flexible member suture (112), a saddle (108) and a soft anchor (104) can be provided with distinguishing characteristics such as colors or designs, or indica which facilitates both tissue fixation and visibility for surgeons (see [0034] disclosing distinguishing characteristics help with correct suture identification and in assisting with specific surgical steps, (e.g., securing an artificial valve to a native heart annulus)). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Lattouf’s method of having each suture with an included pledget attached to the first set of sutures with the first distinguishing feature and the pledget of the second set of sutures with the second distinguishing feature in order to distinguish between the two sets of sutures/pledgets to reinforce the suture point and prevent the thread from tearing through the heart valve tissue when tensioned, wherein coupling a first tissue to a second tissue with a flexible member (e.g., suture) anchored with a soft anchor (104) which acts as a pledget to prevent the flexible member from pulling through while allowing for tightening of the flexible member in order to secure and stabilize the repair site as taught by Durando. Doing so would provide a means for a knotless heart valve replacement or repair, with a secure tissue fixation method, and distinguishing features that allows surgeons to manage multiple suture lines.
Regarding claim(s) 2-5, 11, 12, 16, 17 and 20, Lattouf discloses the surgical method of claim 1, but fails to disclose wherein the first distinguishing feature is a first color; the second distinguishing feature is a second color; the first color is white; the second color is blue; the first distinguishing feature is a first color and the second distinguishing feature is a second color; the first color is white and the second color is blue; the first distinguishing feature is a first color and the second distinguishing feature is a second color; the first color is white and the second color is blue; and the first distinguishing feature is a first color and the second distinguishing feature is a second color.
Durando also discloses a non-sliding, soft anchor (104) suture construct for automatic, friction-based locking of a suture. Durando teaches the first portion (116) and a second portion (124) of the flexible member suture (112), a saddle (108) and a soft anchor (104) can be provided with distinguishing characteristics such as colors or designs, or indica which facilitates both tissue fixation and visibility for surgeons (see [0034] disclosing distinguishing characteristics help with correct suture identification and in assisting with specific surgical steps, (e.g., securing an artificial valve to a native heart annulus)). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Lattouf’s method of having each suture with an included pledget attached to the first set of sutures with the first distinguishing feature and the pledget of the second set of sutures with the second distinguishing feature in order to distinguish between the two sets of sutures/pledgets to reinforce the suture point and prevent the thread from tearing through the heart valve tissue when tensioned, wherein coupling a first tissue to a second tissue with a flexible member (e.g., suture) anchored with a soft anchor (104) which acts as a pledget to prevent the flexible member from pulling through while allowing for tightening of the flexible member in order to secure and stabilize the repair site as taught by Durando. Doing so would provide a means for a knotless heart valve replacement or repair, with a secure tissue fixation method, and distinguishing features that allows surgeons to manage multiple suture lines.
Regarding claim(s) 6-9, 13, 14, and 18, Lattouf discloses the surgical method of claim 1, but fails to disclose wherein the first distinguishing feature is a first pattern; the second distinguishing feature is a second pattern; the first pattern includes stripes; the second pattern includes dots; the first distinguishing feature is a first pattern and the second distinguishing feature is a second pattern; the first pattern includes stripes and the second pattern includes dots; and the first distinguishing feature is a first pattern and the second distinguishing feature is a second pattern.
Durando also discloses using different designs to distinguish portions of the suture (see [0034]; [0042] disclosing the use of different patterns, such as a candy cane stripe along a first and second portion (116 and 124) of a suture (112)). Durando teaches distinguishing characteristics of patterns can be used to assist surgeons in identifying elements of the suture system. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Lattouf’s of using different colors on one suture (112) and another (114) for visual distinction, wherein color coatings (e.g., dots and candy cane stripes) can be applied to differentiate suture portions (116 and 124) as taught by Durando. Doing so would provide a means to differentiate suture ends, prevent confusion, serve as a guide to ensure correct suture ends are brought together and tied to improve procedural efficiency.
Regarding claim(s) 10 and 15, Lattouf discloses a surgical method for attaching a medical device to a human body part (see [0010] disclosing heart valve replacement surgery by attaching the replacement valve to heart tissue), the surgical method comprising: obtaining a first set of sutures (112), wherein each suture from the first set of sutures (112) has a surgical thread with two ends (111), a first needle secured to the first end of the thread, a second needle attached to the second end of the thread, and a pledget (116), the thread and the pledget (116) both having a first distinguishing feature (see [0016], [0039],[0040] disclosing distinguishing features of the pledget (116) and suture (114)); obtaining a second set of sutures (114), wherein each suture from the second set of sutures (114) has a surgical thread with two ends, a first needle secured to the first end of the thread, a second needle attached to the second end of the thread, and a pledget (116), the thread and the pledget (116) both having a second distinguishing feature (see [0016],[0039] and [0040] disclosing the needles (110) each having first and second needles connected to the first (112)and second (114) sutures with distinguishing features); attaching a suture from the first set of sutures (112) to the human body part by passing the first and second needles of the suture through the human body part then passing the first and second needles through the medical device (see [0016] disclosing suture attachment of a first and second tissue with a first and second needle suture combination); attaching a suture from the second set of sutures (114) to the human body part adjacent the suture from the first set of sutures (112) by passing the first and second needles of the suture through the human body part then passing the first and second needles through the medical device(see [0016] disclosing the needles (110) passing through a first tissue (native valve annulus) and then through a second tissue (sewing ring of an artificial valve); repeating both the attaching steps with alternating sutures from the first and second sets of sutures such that adjacently positioned sutures are not from the same set of sutures (see [0048] disclosing the use of adjacent positioned sutures); after all of the sutures are placed, tightening the ends of the sutures to firmly seat the pledgets (116) against the human body part or the medical device (see [0044]; [0047] disclosing using tension on sutures (112 and 114) in order to tie them tightly to the pledget (116) to join heart tissue X with the replacement valve; and tying the ends of the tightened sutures (see [0047] and [0048] disclosing steps for placing all sutures (112 and 114), tightening them and tying the ends (111) of the sutures (114)). Latouff fails to disclose each pledget having a distinguishing feature.
Durando also discloses a non-slip suture construct (100) for coupling tissues. Durando teaches a soft anchor (104) and a saddle (108) system acting as a pledget which can have distinguishing features of colors or designs, along a first (116) and second (124) suture portion which can also have distinguishing features of colors or designs (see [0034] disclosing the components of the suture construct (100) which can be modified with colors or designs). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Lattouf’s needle suture combination (25) using two sutures (112 and 114) and a pledget (116) with alternating colors to secure it to a native valve annulus and a sewing ring of an artificial valve, wherein applying distinguishing features to any component of the suture system with colors or designs makes suture ends easily distinguishable by surgeons. Doing so would provide a non-slip, secure attachment through the use of distinguishable pledgets and sutures which allows for a tighter valve seal.
Regarding claim 19, Lattouf in view of Durando discloses a suture system for attaching an artificial heart valve to a native valve annulus (see [0010] disclosing heart valve replacement surgery by attaching the replacement valve to heart tissue), the suture system comprising:
a first set of sutures (112), each suture from the first set of sutures comprising:
a surgical thread with two ends (111),
a first needle (110) secured to the first end of the thread,
a second needle (110) attached to the second end of the thread, and
a pledget (116),
wherein the thread and the pledget (116) both have a first distinguishing feature (see [0039], [0040] and [0045] disclosing a first (112) and second set (114) of sutures having two ends (111), wherein both having a first distinguishing feature); a second set of sutures (114), each suture from the second set of sutures comprising:
a surgical thread with two ends (111),
a first needle secured to the first end of the thread,
a second needle attached to the second end of the thread, and
a pledget (116),
wherein the thread and the pledget (116) both have a second distinguishing feature (see [0016], [0039], [0040] and [0045] disclosing a first (112) and second set (114) of sutures having two ends (111), wherein both having a second distinguishing feature and having a first and second needle suture combination);
a suture from the first set of sutures (112) configured to be attached to the native valve annulus by passing the first and second needles (110) of the suture through the native valve annulus then passing the first and second needles through a sewing ring of the artificial valve (see [0046] disclosing inserting the needles (110) through heart tissue (native heart annulus) and through the replacement valve (sewing ring) and pulling on sutures (112 and 114) through the replacement valve in order to make contact with the heart tissue);
a suture from the second set of sutures (114) configured to be attached to the native valve annulus adjacent the suture from the first set of sutures (112) by passing the first and second needles of the suture through the native valve annulus then passing the first and second needles through the sewing ring of the artificial valve such that adjacently positioned sutures are not from the same set of sutures (see [0016], [0046] disclosing the surgical step for attaching sutures with a first and second needle suture combination to the native valve annulus in a preferred adjacent position, wherein the second suture (114) would be tied to a different adjacent second suture). Lattouf fails to disclose manually alternating sutures by the surgeon and pledgets (116) having a distinguishing feature.
Durando also discloses a non-slip suture construct (100) for coupling tissues. Durando teaches a soft anchor (104) and a saddle (108) system acting as a pledget which can have distinguishing features of colors or designs, along a first (116) and second (124) suture portion which can also have distinguishing features of colors or designs (see [0034] disclosing the components of the suture construct (100) which can be modified with colors or designs). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Lattouf’s needle suture combination (25) using two sutures (112 and 114) and a pledget (116) with alternating colors to secure it to a valve annulus and a sewing ring of an artificial valve, wherein applying distinguishing features to any component of the suture system with colors or designs makes suture ends easily distinguishable by surgeons. Doing so would provide a non-slip, secure attachment through the use of distinguishable pledgets and sutures which allows for a tighter valve seal.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEFAN BRADLEY CAMPBELL whose telephone number is (571)272-3498. The examiner can normally be reached Monday - Thursday 6:00am-5:00pm.
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/STEFAN BRADLEY CAMPBELL/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799