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 2 is objected to because of the following informalities: Claim 2 ends in “;” rather than a period. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Claim 3 recites “wherein the first mechanism”. Claim 1 recites “a first actuation mechanism”. Applicant is encouraged to maintain consistent terminology throughout the claims for clarity. Examiner suggests amending claim 3 to recite “wherein the first actuation mechanism…” Appropriate correction is required.
Many of the claims fail to use “the” before reciting a previously recited structure (See, for example, Claim 16 “wherein delivery device”; claim 17 “wherein distal ends”). Applicant is encouraged to use proper conventional grammar throughout the claims for clarity. 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.
Claims 4, 5, 7, 15, and 16 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.
Claim 4 depends upon claim 3. Claim 4 recites “wherein the first actuation mechanism is an arm actuator made of…”. Claim 3 also recites “wherein the first mechanism is an arm actuator”. It is unclear if claim 4 is attempting to refer back to the arm actuator as recited in claim 3 or if applicant is attempting to claims a second separate structure. For the purposes of examination, this limitation is being interpreted as referring back to the same arm actuator as recited in claim 3. Examiner suggests amending the claim to read “wherein the is made of…”. Applicant may instead amend claim 4 to be dependent on claim 1 to resolve the antecedent basis issue.
Claim 7 recites the limitation “wherein the one or more pullers are…” in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 7 depends upon claim 1 which recites “a second actuation mechanism coupled to the proximal end of the securement arm and configured to pull…” however there is not a recitation of “one or more pullers”. For the purposes of examination, this limitation is being interpreted as “wherein the second actuation mechanism is positioned within a puller lumen.” Appropriate action is required.
Claim 15 recites the limitation “wherein puncture device includes a cannulated needle positioned within the proximal body…”. There is insufficient antecedent basis for this limitation in the claim since claim 10 does not recite “a proximal body”. As can best be understood from applicant’s disclosure, the needle is located within the integrated therapy catheter. For the purposes of examination, this limitation is being interpreted as “wherein puncture device includes a cannulated needle positioned within the catheter
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5, 17, and 18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 5 recites “wherein the arm actuator is positioned within an arm actuator lumen”. Claim 5 depends on claim 4, which in turn depends on claim 3. Claim 3 recites “the first mechanism is an arm actuator positioned within an arm actuator lumen”. Thus, claim 5 fails to further limit the subject matter of the claim upon which it depends.
Claim 17 recites “wherein distal ends of the first and second tethers are self-expanding and configured to expand larger than the first and second holes.” Claim 17 depends from claim 10 which recites in relevant part “…a first tether with a self-expanding distal end configured to expand larger than the first hole…” in lines 21-23 of the claim. Thus claim 17 fails to further limit the subject matter upon which it depends.
Claim 18 recites “the puncture device configured to puncture the first hole proximate a first leaflet edge and puncture a second hole proximate a second leaflet edge”. Claim 18 depends upon claim 10 which recites in relevant part “…a puncture device configured to puncture a first hole in the first leaflet proximate a first leaflet edge and puncture a second hole in the second leaflet proximate a second leaflet edge…” in lines 17-19.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-7, 9-10, and 15-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raschdorf, Jr. et. al. (US PG Pub 2009/0163934).
Regarding claim 1, Raschdorf teaches a leaflet engagement system (See Figs. 35-43C) comprising: a body portion having a distal end1 with a hinge (See paragraphs [0133] and [0182]);
an engagement arm (18) having proximal end and a distal end (near 52) rotatably coupled to the hinge (See Figs. 35-37);
a securement arm (16) having a proximal end and a distal end fixedly coupled to the
engagement arm (note the connected end of arm 16 is fixedly coupled to arm 18; See paragraphs [0182]-[0185]); and
a first actuation mechanism (200/202/204 in combination) coupled with the hinge configured to rotate the engagement arm and securement arm from a delivery position to a leaflet engagement position (See Figs. 35-43C; paragraphs [0182]-[0185]);
a second actuation mechanism2 (tensioning line 90) coupled to the proximal end of the securement arm configured to pull and flex the proximal end from a closed position (as seen in Figs. 38 &39) to an open position (as seen in Fig. 37) to engage a leaflet between the engagement arm and securement arm. (See paragraphs [0182]-[0185])
Regarding claim 2, Raschdorf teaches the leaflet engagement system as required by claim 1 above and further teaches the leaflet is positioned between the engagement arm (18) and securement arm (16), the second actuation mechanism (line 90) stops pulling to release the securement arm to flex back to clamp the leaflet between the engagement arm and securement arm. (See Figs. 37-40; paragraphs [0151]-[0154] and [0182]-[0185]).
Regarding claim 3, Raschdorf teaches the leaflet engagement system as required by claim 1 above and further teaches the first mechanism is an arm actuator (rod 204) positioned within an arm actuator lumen (note the lumen inside the shaft of the delivery device as well the lumen formed in shaft 198) configured to3 rotate the engagement arm (18) between the delivery position (Fig. 35) and the leaflet engagement position (See Fig. 37-39).
Regarding claim 4, Raschdorf teaches the leaflet engagement system as required by claim 3 above and further teaches the first actuation mechanism is
Regarding claim 5, Raschdorf teaches the leaflet engagement system as required by claim 4 above and further teaches the first mechanism is an arm actuator (rod 204) positioned within an arm actuator lumen (note the lumen inside the shaft of the delivery device as well the lumen formed in shaft 198).
Regarding claim 6, Raschdorf teaches the leaflet engagement system as required by claim 1 above and further teaches the second actuation mechanism is a puller (90) made from sutures (See paragraph [0151]) having a first end coupled to the proximal end of the securement arm (See paragraph [0151]) and a second end at a handle (312) to manually pull and release the proximal end of the securement arm (See paragraphs [0194]).
Regarding claim 7, Raschdorf teaches the leaflet engagement system as required by claim 1 above and further teaches wherein the one or more pullers (second actuation mechanism – tensioning line 90) are positioned within a puller lumen. (See paragraphs [0193]-[0194] which states the “proximal element lines 90 extend through the shaft 302 of the delivery catheter 300 and connect with the proximal elements 16” Thus, the lines 90 extend through a lumen which can reasonably be called a “puller lumen” since the only affirmative structure required of the “puller lumen” is that it be a “lumen”.
Regarding claim 9, Raschdorf teaches the leaflet engagement system as required by claim 1 above and further teaches the securement arm (16) is made of a flexible, spring like material (See paragraph [0146]).
Regarding claims 10, 17, and 184, Raschdorf teaches system for edge-to edge repair of a mitral valve comprising an integrated therapy catheter (entire system) configured to5 engage a first leaflet and a second leaflet of a mitral valve comprising:
a leaflet engagement system (See Figs. 35-43C) having: a body portion having a distal end6 with a hinge (See paragraphs [0133] and [0182]);
an engagement arm (18) having proximal end and a distal end (near 52) rotatably coupled to the hinge (See Figs. 35-37);
a securement arm (16) having a proximal end and a distal end fixedly coupled to the
engagement arm (note the connected end of arm 16 is fixedly coupled to arm 18; See paragraphs [0182]-[0185]); and
a first actuation mechanism (200/202/204 in combination) coupled with the hinge configured to rotate the engagement arm and securement arm from a delivery position to a leaflet engagement position (See Figs. 35-43C; paragraphs [0182]-[0185]);
a second actuation mechanism7 (tensioning line 90) coupled to the proximal end of the securement arm configured to pull and flex the proximal end from a closed position (as seen in Figs. 38 &39) to an open position (as seen in Fig. 37) to engage a leaflet between the engagement arm and securement arm; (See paragraphs [0182]-[0185])
a puncture device (220) configured to puncture a first hole in the first leaflet proximate a first leaflet edge and puncture a second hole in the second leaflet proximate a second leaflet edge (See Fig. 38; paragraph [0184]);
a delivery device configured to:
deliver a first leaflet anchor (222) through the first hole to a distal side of the first leaflet, the first leaflet anchor having a first tether (226) with a self-expanding distal end (228) configured to expand larger than the first hole and engage the distal side of the first leaflet (See Figs. 43A-43C; paragraphs [0184]-[0186]); and
deliver a second leaflet anchor (222) through the second hole to a distal side of the second leaflet, the second leaflet anchor having a second tether (226) with a self-expanding distal end (228) configured to expand larger than the first hole and engage the distal side of the second leaflet (See Figs. 40A-40D and 43A-43C, note there are two anchors, sutures, pledgets, etc. one for each leaflet; See also paragraphs [0184]-[0186]); and
a "knot replacement" tool (232) configured to couple with the first tether (226) and the second tether (226) and tension the first tether and the second tether to bring first leaflet edge and the second leaflet edge together, and lock the first tether and tether second tether together (See paragraph [0186]).
Regarding claim 15, Raschdorf teaches the leaflet engagement system as required by claim 10 above and further teaches puncture device includes a cannulated needle (220) (See Figs. 40a-40D) positioned within the proximal body (catheter 86) configured to extend distally to puncture a hole in the leaflet. (See Figs. 39, 41, and 42; paragraph [0184])
Regarding claim 16, Raschdorf teaches the leaflet engagement system as required by claim 10 above and further teaches the delivery device is configured to deliver a leaflet anchor (222) through the cannulated needle (note anchor is carried within sleeve 224) (See Figs. 40A-40D; paragraphs [0184]-[0185])
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 8 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Raschdorf, Jr. et. al. (US PG Pub 2009/0163934).
Regarding claim 8, Raschdorf teaches the leaflet engagement system as required by claim 1 above and further teaches the second actuation mechanism (tension line 90) flexes the securement arm sufficiently away from the engagement arm (See Figs. 35-37; paragraphs [0151]-[0154] and [0182]-[0185]) while at approximately a 45-degree angle (See Fig. 37) so that the leaflet can be positioned between them (See paragraphs [0182]-[0185]). It is noted that Fig. 37 shows the securement arm (16) separated from the engagement arm (18) so that the leaflet can be positioned and held therebetween (See Fig. 38-39). Fig. 37 appears to show the angle between the two arms is approximately 45 degrees. It is further noted that there is at least one moment during the leaflet capturing process where the angle between the two arms is approximately 45 degrees since the arms start in the position as seen in Fig. 35 where the angle is clearly greater than 45 degrees and ends with the leaflet captured between the leaves as shown in Figs. 38 and 39 where the angle between the arms is clearly less than 45 degrees.
Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device as taught by Raschdorf such that the second actuation mechanism flexes the securement arm away from the engagement arm while at approximately a 45-degree angle since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955). See also MPEP §2144.05.
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raschdorf, Jr. et. al. (US PG Pub 2009/0163934) as applied to claim 10 above, and further in view of Ek et al (US Pat. No. 6,086,608).
Regarding claim 11, Raschdorf teaches the system required by claim 10 as set forth above but is silent as to the particular features of the knot replacement tool.
Ek teaches an analogous knot replacement tool (collet 10) including a locking cap (ring 12) having first and second tether locking cap holes (tunnels 24 and 26), the first and
second tethers (8) being inserted through the first and second locking cap holes; and
a locking screw (pin 14) having first and second tether locking screw holes (See Figs. 1-3 and 6A), the first and second tethers being inserted through the first and second locking screw holes; wherein the locking screw is configured8 to be screwed into the locking cap, with
the first and second tether locking screw holes and the first and second tether locking
cap holes rotated in opposite directions so that the first tether and second tether are
twisted around each other and are locked in place. (See Figs. 2-6; Col. 3, lines 20-68 and Col. 4, lines 4-68).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to modify the knot replacement tool of Raschdorf such that it comprises a structure of a locking cap having first and second tether locking cap holes and a locking screw having first and second tether locking screw holes, wherein the locking screw is configured to be screwed into the locking cap, with the first and second tether locking screw holes and the first and second tether locking cap holes rotated in opposite directions so that the first tether and second tether are twisted around each other as taught by Ek in order to provide a simple, reliable mechanism to lock the suture in place when desired. It is noted that Raschdorf explicitly states “It may be appreciated that the suture fastener 232 may have any suitable form.” (See paragraph [0186]. Additionally, a wide variety of suture knot replacement mechanisms are known and used in the art. As stated in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United States v. Adams, 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B).
Regarding claim 12, modified Raschdorf teaches the system required by claim 10 as set forth above and further teaches the “knot replacement” tool further includes a detachable delivery shaft (84) coupled to the locking screw (pin 14) (See Ek Figs. 7-8; Col. 5, lines 39-48).
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Raschdorf, Jr. et. al. (US PG Pub 2009/0163934) as applied to claim 10 above, and further in view of Findlay (US PG Pub 2007/0005081).
Regarding claims 13 & 14, Raschdorf teaches the system required by claim 10 as set forth above but is silent as to a cutter device configured to cut the tethers.
Findlay teaches an analogous system featuring a suture cutting device (device for securing and cutting a suture via catheter, paragraph [0008]) configured to cut the first and second tethers including:
an outer body (12) with an outer body side opening (38) (see Fig 2b, paragraph [0043]); and
an inner body (26) with an inner body side opening (34) (see Fig 2a, paragraph [0043]) slidably positioned within the outer body (longitudinally slidable inner body 26 within main body 12, paragraph [0042]), the inner body side opening and the outer body side opening are positioned to provide an opening to a center lumen (see how openings 34 and 38 are aligned to provide an opening to a center lumen for suture 50, Fig 5a),
wherein the first and second tethers enter a distal end of the center lumen and exit out through the inner body side opening and outer body side opening (see how suture strands 50a and 50b enter a right end of the center lumen and exit out the side openings 34 and 38, Fig 5b), and axial movement of the inner body in relation to the outer body side opening closes the opening to the center lumen and scissor cuts the first and second tethers (see how axial movement of inner body 26 closes the opening to cut the suture strands 50a and 50b, Fig 5c, as inner body 26 is retracted the suture leads 50a, 50b are cut, paragraph [0053]) in order to provide the mechanism to cut the suture (to provide a device capable of cutting suture, paragraph [0008]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the mitral valve repair system as taught by Raschdorf so as to include a cutter device with the recited sliding inner and outer bodies with a side opening for cutting sutures, as taught by Findlay, in order to provide a reliable and low profile mechanism for cutting the first and second tethers as desired during the procedure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL S. HIGHLAND whose telephone number is (571)270-3254. The examiner can normally be reached on Monday through Thursday between 9:30am and 2:30pm .
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.S.H/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
1 It is noted that “proximal” and “distal” are relative terms. It is further noted that while "distal" is often used to describe the portion of a device farthest from the operator, it is also used in the medical art to describe the portion closest to the operator. Further, “proximal” and “distal” are defined by Merriam-Webster in relation to the center of the body. In the instant case, the portions of the arms connected to the shaft can be considered distal and the free ends of the arms can be considered proximal.
2 Note paragraph [0185] sates “The proximal elements 16 may also be returned to their initial position as shown, using any of various mechanisms as have been described above in connection with other embodiments.” Paragraphs [0151]-[0154] describe the proximal arms (16) being biased towards arms 53/18 and may be held against the shaft with the aid of lines 90 via tension exerted on the lines 90.
3 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). In the instant case, movement of the rod 204 causes rotation of the arms 18.
4 As noted in the 112 section above, the limitations of claim 17 and 18 are already required by claim 10.
5 It is noted that this is a recitation of intended use in the preamble and not given full patentable weight, in that the prior art is not required to disclose this function/method of use. Since the body of the claim in the instant case fully and intrinsically sets forth all the limitations of the claimed invention, the preamble recitation of intended use is not considered a claim limitation. Additionally, MPEP 2111.02(II) states: “If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997)”. In the instant case, Raschdorf expressly teaches using the inventive system on a mitral valve (See, for example, paragraphs [0010] and [0098])
6 It is noted that “proximal” and “distal” are relative terms. It is further noted that while "distal" is often used to describe the portion of a device farthest from the operator, it is also used in the medical art to describe the portion closest to the operator. Further, “proximal” and “distal” are defined by Merriam-Webster in relation to the center of the body. In the instant case, the portions of the arms connected to the shaft can be considered distal and the free ends of the arms can be considered proximal.
7 Note paragraph [0185] sates “The proximal elements 16 may also be returned to their initial position as shown, using any of various mechanisms as have been described above in connection with other embodiments.” Paragraphs [0151]-[0154] describe the proximal arms (16) being biased towards arms 53/18 and may be held against the shaft with the aid of lines 90 via tension exerted on the lines 90.
8 It is noted that the instant claims are drawn to an apparatus, and “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).” A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP §2114(II). As long as the prior art meets the structural requirements and is capable of performing the functions, the prior art meets the limitations. In the instant case, the device of Ek meets all the structural requirements and is capable of performing the intended function, rotating. (See also Col. 9, lines 43-60).