DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
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 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.
Drawings
The drawings are objected to because: Figs. 2A-F, 4-5B, 26A-C & 26A-B are shaded & Figs. 20-25B & 27A-28B are shaded photographs.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 18 is objected to because of the following informalities: amend “puncturing tissue” to -puncturing the tissue- in ll. 2. Appropriate correction is required.
Claim 99 is objected to because of the following informalities: amend “seats” to -sits- in ll. 7. 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 1-3, 5-7, 17-19, 32, 35, 38, 42, 49, 54-55, 59-60 & 104-105 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 1 recites the limitation “wherein the barb is fixed relative to the second catheter and a distalmost end of the barb is spaced apart proximally from a proximalmost end of the dilator”. However, the originally filed disclosure fails to provide support for both: “the barb is fixed relative to the second catheter” and “a distalmost end of the barb is spaced apart proximally from a proximalmost end of the dilator”. Figs. 4-7C, 19A-F & 20-21 illustrate the barb distalmost end to be spaced distally from a proximalmost end of the dilator. Figs. 8-10B fail to show the barb distalmost end with respect to the dilator proximalmost end. Fig. 22, 27A-B, 28A-29C & 31D-32 is not clear to determine where the barb distalmost end is located with respect to the dilator proximalmost end. Fig. 38A-B illustrated the barb distalmost end to be at the same location as the dilator proximalmost end. Fig. 30A-B illustrate the barb distalmost end to be spaced proximally from a proximalmost end of the dilator, but also disclose the barb is slidably disposed and not fixed relative to the second catheter. Thus, there is no support in the originally filed disclosure for claim 1.
Claims 2-3, 5-7, 17-19, 32, 35, 38, 42, 49, 54-55, 59-60 & 104-105 depend from claim 1 and are thus also rejected.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-4, 18-19, 49, 59, 99 & 104-105 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kellerman et al. (2011/0306959) in view of Blatter et al. (2010/0121358).
Concerning claim 1, as illustrated in at least Fig. 1, Kellerman et al. disclose a system for forming an anastomosis in a heart (bi-polar tapered tip catheter 10; [0035]), comprising:
a first catheter comprising an electrode (elongate outer tube 12 comprises proximal electrode 20; [0035]); and
a second catheter slidably disposed within the first catheter (tubular structure 18 is slidable disposed within elongate outer tube 12; [0035]), the second catheter comprising a dilator comprising an electrode mating surface (tubular structure 18 comprises distal RF electrode 22 and dilating distal tip 18; [0035]).
Kellerman et al. fail to disclose the second catheter comprising a substantially fixed diameter barb, wherein the barb is fixed relative to the second catheter and a distalmost end of the barb is spaced apart proximally from a proximalmost end of the dilator. However, Blatter et al. disclose a system comprising a first and second catheters (101, 109) slidably disposed with respect to one another, wherein one of the catheters (101) comprises a fixed diameter barb (115) having one or more sharp or pointed ends that is fixed relative to the other catheter (109). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Kellerman et al. to further comprise a substantially fixed diameter barb that is fixed relative to one of the catheters in order to provide the benefit of gripping, capturing, or otherwise holding the tissue to facilitate improved capture of the tissue between the two catheter surfaces as taught by Blatter et al. ([0079], [0081-0083]; Fig. 7-8)
Reu et al. in view of Blatter et al. fail to specifically disclose the second catheter comprising the barb and the barb is fixed relative to the second catheter. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Reu et al. in view of Blatter et al. such that the barb is fixed relative to the second catheter, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
The modified in invention of Reu et al. in view of Blatter et al. then teach that a distalmost end of the barb is spaced apart proximally from a proximalmost end of the dilator since the barb since the barb is disposed on the surface of heat spreader (24).
Concerning claim 3, Kellerman et al. disclose an outer diameter of the dilator (18) at its more distal end is less than an outer diameter of the electrode (20) (Fig. 1).
Concerning claim 4, Blatter et al. disclose the first and second catheters define a longitudinal axis, wherein the barb (115) comprises at least one projection comprising a first portion angled relative to a second portion (Fig. 6).
Concerning claim 18, Kellerman et al. disclose the electrode (20) and the electrode mating surface are configured to compress tissue therebetween without puncturing tissue ([0035], [0039]; Fig. 1).
Concerning claim 19, Kellerman et al. disclose the second catheter (16) defines a longitudinal axis, and the electrode mating surface (22) is non-perpendicular and non-parallel to the longitudinal axis (Fig. 1).
Concerning claim 49, Kellerman et al. disclose a first catheter actuator (42) configured to deflect a distal portion of the first catheter (12) by physically moving the handle (42), the first catheter actuator (42) electrically coupled to the electrode (electrical connection in handle) ([0043]; Fig. 10).
Concerning claim 59, Kellerman et al. disclose the electrode mating surface (22) comprises a conductive portion (22) ([0035]; Fig. 1).
Concerning claim 104, Blatter et al. disclose the barb (115) comprises a plurality of projections spaced apart from each other by a fixed distance (Fig. 8).
Concerning claim 105, Blatter et al. disclose each projection (115) of the plurality of projections is at a fixed angle (angle of 0 degrees) relative to the second catheter (Fig. 8).
Concerning claim 99, as illustrated in at least Fig. 1, Kellerman et al. disclose a system for forming an anastomosis in a heart (bi-polar tapered tip catheter 10; [0035]), comprising:
a first catheter comprising an electrode (elongate outer tube 12 comprises proximal electrode 20; [0035]); and
a second catheter slidably disposed within the first catheter (tubular structure 18 is slidable disposed within elongate outer tube 12; [0035]), the second catheter comprising a dilator comprising an electrode mating surface (tubular structure 18 comprises distal RF electrode 22 and dilating distal tip 18; [0035]),
wherein the electrode seats against the electrode mating surface to form a stop, wherein the stop is configured to restrict proximal translation of the dilator relative to the electrode (electrode 20 and 22 seat against one another to form a stop that restricts proximal translation of the tubular structure 18 relative to electrode 20; Fig. 1).
Kellerman et al. fail to disclose the second catheter comprising a barb comprising a plurality of projections, wherein a largest outer diameter of the plurality of projections is substantially constant and less than a largest outer diameter of the electrode mating surface. However, Blatter et al. disclose a system comprising a first and second catheters (101, 109) slidably disposed with respect to one another, wherein one of the catheters (101) comprises a barb comprising a plurality of projections (115), wherein a largest outer diameter of the plurality of projections is substantially constant and less than a largest outer diameter of an electrode mating surface (104). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Kellerman et al. to further comprise the second catheter comprising a barb comprising a plurality of projections, wherein a largest outer diameter of the plurality of projections is substantially constant and less than a largest outer diameter of the electrode mating surface in order to provide the benefit of gripping, capturing, or otherwise holding the tissue to facilitate improved capture of the tissue between the two catheter surfaces as taught by Blatter et al. ([0079], [0081-0083]; Fig. 7-8)
Reu et al. in view of Blatter et al. fail to specifically disclose the second catheter comprising the barb. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Reu et al. in view of Blatter et al. such that the second catheter comprises the barb, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kellerman et al. (2011/0306959) in view of Blatter et al. (2010/0121358), as applied to claim 1, in further view of Lashakove et al. (WO 2005/013836).
Concerning claim 2, Kellerman et al. in view of Blatter et al. fail to specifically disclose the barb is disposed within a lumen of the electrode when the electrode mating surface engages the electrode. However, Lashakove et al. disclose a system for forming an anastomosis comprising first and second catheters (120, 102), a plurality of barbs (114) fixed relative to the second catheter (102) that are disposed within a lumen of the mating surface of the first catheter (120). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Kellerman et al. in view of Blatter et al. such that the barb is disposed within a lumen of the electrode when the electrode mating surface engages the electrode in order to provide the benefit of not tearing tissue during insertion as taught by Lashakove et al. (Pg. 5, ll. 17-28; Fig. 1A)
Claim(s) 6-7 & 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kellerman et al. (2011/0306959) in view of Blatter et al. (2010/0121358), as applied to claim 5.
Concerning claim 6-7 & 17, Kellerman et al. in view of Blatter et al. fail to disclose a length of the first portion to a length of the second portion is in a ratio between about 2:3 and about 1:5, the second portion comprising a length between 0.1 mm and about 2 cm, nor the length of the barb to be between about 0.1 mm and about 5 cm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Kellerman et al. in view of Blatter et al. such that a length of the first portion to a length of the second portion is in a ratio between about 2:3 and about 1:5, the second portion comprising a length between 0.1 mm and about 2 cm, nor the length of the barb to be between about 0.1 mm and about 5 cm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the modified invention of Kellerman et al. in view of Blatter et al. would not operate differently with the claimed ratio and length. Further, applicant places no criticality on the range claimed, indicating simply that the diameter “may” be within the claimed ranges (“In some variations, a length of the projection (1320) and/or tissue engagement portion (1322) may be between about 0.1 mm and about 2 cm “ and “In some variations, a length of the barb (2600) may be between about 0.1 mm and about 5 cm. In some variations, a length of the proximal portion to a length of the distal portion may be in a ratio between about 2:3 and about 1:5.”, [0134], [0142])
Claim(s) 32, 35 & 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kellerman et al. (2011/0306959) in view of Blatter et al. (2010/0121358), as applied to claim 1, in further view of Miller et al. (2015/0080886).
Concerning claims 32, 35 & 38, Kellerman et al. in view of Blatter et al. fail to disclose the dilator comprises a fluid port configured to output a contrast agent, the first catheter comprises a contrast agent lumen, nor the electrode comprises a fluid port configured to output a contrast agent. However, Miller et al. disclose a system for forming anastomoses where the catheters may additionally comprise one or more lumens or passageways extending at least partially along or through the catheter, and may be used to pass one or more guidewires, one or more drugs or fluids (e.g., contrast agents, perfusion fluids), combinations thereof, or the like at least partially along or through the catheter ([0033]). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Reu et al. in view of Blatter et al. such that system comprises a fluid port configured to output a contrast agent form a contrast agent lumen in order to provide the benefit of viewing the fluid flow in the treatment area as taught by Miller et al. ([0033], [0137-0138], [0163]). Kellerman et al in view of Blatter et al. and Miller et al. fail to specifically disclose the location of the fluid port and/or lumen. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Reu et al. in view of Blatter et al. and Miller et al. such that the dilator comprises the fluid port, the first catheter comprises the contrast agent lumen, or the electrode comprises a fluid port, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kellerman et al. (2011/0306959) in view of Blatter et al. (2010/0121358), as applied to claim 1, in further view of Coker et al. (2018/0199915).
Concerning claim 42, Kellerman et al. in view of Blatter et al. fail to disclose the dilator comprises an echogenic region comprising one or more recesses or protrusions comprising a diameter of about 5 mm and about 100 mm. However, Coker et al. disclose a medical system where echogenic components (30) are formed around an outer diameter (23) of a catheter (14) and includes a plurality of discontinuities to enhance ultrasonic imaging, the discontinuities (30) comprising one or more recesses or protrusions comprising a diameter of about 5 mm and about 100 mm. At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Kellerman et al. in view of Blatter et al. such that the dilator comprises an echogenic region comprising one or more recesses or protrusions comprising a diameter of about 5 mm and about 100 mm in order to provide the benefit of enhancing ultrasonic imaging as taught by Coker et al. ([0058], [0060]; Fig. 11-15).
Claim(s) 54-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kellerman et al. (2011/0306959) in view of Blatter et al. (2010/0121358), as applied to claim 1, in further view of Foerster (2017/0049450).
Concerning claim 54, Reu et al. in view of Blatter et al. fail to disclose the electrode mating surface defines a recess configured to receive a distal end of the electrode. However, Foerster et al. disclose an anastomoses system comprising an electrode mating surface (24) defines a recess (15) configured to receive a distal end of an electrode (12, 9). At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Reu et al. in view of Blatter et al. such that the electrode mating surface defines a recess configured to receive a distal end of the electrode in order to provide the benefit of two heating elements coming into direct contact with one another to ensure a complete cut and capture of the vessel tissue as taught by Foerster et al. ([0066], [0083-0084]; Fig. 3 & 5).
Concerning claim 55, Kellerman et al. further disclose the electrode (20) is configured to electrically short when the electrode (20) engages the electrode mating surface (22) if controlled tension is not maintained ([0040]).
Claim(s) 1 & 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arevalos et al. (WO2018/148456) in view of Clague et al. (2004/0082945).
Concerning claim 1, as illustrated in at least Fig. 15A-15C, Arevalos et al. disclose a system for forming an anastomosis in a heart (device assembly 1500; [0186]), comprising:
a first catheter (delivery catheter 1510 or cutter 1508; [0186]); and
a second catheter slidably disposed within the first catheter (catheter 1502 & 1524 is slidably disposed within delivery catheter 1510 or cutter 1508; [0186]), the second catheter comprising a barb and a dilator comprising a mating surface (catheter 1502 comprises stabilizing element 1504, 1505 and dilating tip 1501; [0186]), wherein the barb is fixed relative to the second catheter (stabilizing element 1504, 1505 have ends that are fixed to catheter 1524; [0183]) and a distalmost end of the barb is spaced apart proximally from a proximalmost end of the dilator (distalmost end of stabilizing element 1504 is spaced proximally from a proximal most end of the dilator 1501; [0186]).
Arevalos et al. fail to disclose the first catheter comprising an electrode and the dilator mating surface to be an electrode mating surface. However, Clague et al. disclose a device for creating a fistula where a cutting member (52 or 62) is operable to mechanically cut, and also electrically cut an opening in the vessel wall. At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Arevalos et al. such that the first catheter comprises an electrode and the dilator mating surface to be an electrode mating surface in order to provide the benefit of enhancing the mechanical cutting, inhibiting blood loss as the incision, and to make a clean incision is made as taught by Clague et al. ([0024], [0028-0029], [0098-0101]; Fig. 6).
Concerning claim 60, Arevalos et al. disclose a proximal portion of the dilator (1501) is arranged within a lumen of the cutting member (1510/1508) when the cutting member mating surface (1522) engages the cutting member (1510, 1508) , when all elements are withdrawn (Fig. 14B-C & 15A-B).
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Foerster et al. (10,292,708) teach an anastomosis system comprising first and second catheters and barb cutting mechanism (14) on the first catheter (8). Golden et al. (6,695,859) teach barbs (729) on a centering disk (720) to aide in cutting tissue (Fig. 15A-B). Golden et al. (2019/0357933) teach a barb (330) that is fixed relative to a second catheter (245), but fail to teach the distalmost end of the barb spaced apart proximally form a proximalmost end of a dilator (315) (Fig. 3E).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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