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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 2-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,701,158. Although the claims at issue are not identical, they are not patentably distinct from each other because they encompass the same essential invention.
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.
Claims 2-3 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nau, Jr. (U.S. Patent Application Publication 2010/0179539).
Regarding claim 2, Nau, Jr. disclose a system comprising:
an ablation catheter comprising:
a shaft ("shaft" 12, see [0020] and figure 1 for example) including:
a proximal end ("proximal end" 16, see [0020] and figure 1 for example),
a distal portion( extending from the middle of the shaft 14 to the distal end where "jaw members" 110 and 120 are disposed, see [0020] and figure 1 for example); and
a distal end (the distal end is where "jaw members" 110 and 120 are disposed, see [0020] and figure 1 for example);
an ablation element ("one or both of the seal plates" 118 and/or 128, see [0018] and figures 3A and 3B for example) configured to deliver energy to tissue; and
a force maintenance assembly comprising a force maintenance element configured to control and/or assess contact force between the ablation element and cardiac tissue, wherein the force maintenance element comprises a piston ( comprising "plunger" 202 and "drive assembly" 130, see [0027], [0029] and figures 1, 3A, and 3B for example), the piston extending from the shaft distal end;
it should be further noted the force maintenance assembly is configured to control a fluid flow to the hydraulic piston to adjust, maintain, and/or control a hydraulic pressure that the hydraulic piston exerts on and/or against the tissue (consider the "drive assembly" 130 portion of the force maintenance assembly, see [0029] and figures 1, 3A, and 3B), and
a console configured to operably attach to the ablation catheter and comprising:
an energy delivery assembly (comprising "source of electrosurgical energy, e.g., generator" 200, see [0024] for example) configured to provide energy to the ablation element.
Regarding claim 3, Nau, Jr. disclose the claimed invention, see figures 3A-3B.
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.
Claim 2, 4-18, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Barley et al. (U.S. Patent Application Publication 2012/0165669) in view of Willis (U.S. Patent Application Publication 2007/0049821) in view of Belson et al. (U.S. Patent Application Publication 2013/0066304).
Regarding claim 2, Barley et al. disclose an ablation system comprising:
an ablation catheter comprising:
a shaft (the shaft of "elongated body" 3, see [0043] and figures 1-11 for example) including a proximal end (the proximal end of the elongate body 3 located adjacent "controller unit" 111, see figure 11), a distal portion (comprising the distal half of running from the distal end 1 to the middle of elongate member 3, see figure 11 for example) and a distal end ("distal end region" 1, see [0043] and figure 11 for example);
an ablation element (wherein "ablation element" is merely interpreted as an element or electrode since there is no positive recitation of type of ablation energy like in claims 96 and 97 and claim 1 only recites "configured to deliver energy to tissue," so "tip electrode" 14 serves as the "ablation element" or element since it delivers at the very lease mechanical energy in the form of force times distance (i.e., contact energy), see "ablation electrode" 20 in [0048] and figures 1-2 for example) configured to deliver energy to tissue; and
a force maintenance assembly comprising:
a force maintenance element ( comprising a piston or piston like element "transmission element" 5, see [0048] and figures 1-11) configured to control and/or assess contact force between the ablation element and tissue, wherein the force maintenance element comprises a piston ( comprising a piston or piston like element "transmission element" 5, see [0048] and figures 1-11), the piston extending from the shaft distal end; and
a console ("controller unit" 111, see [0067] and figure 11) configured to operably attach to the ablation catheter.
However, Barley et al. fail to explicitly recite 1) the console further comprises "an energy delivery assembly configured to provide energy to the ablation element," and 2) "the force maintenance assembly is configured to control a fluid flow to the hydraulic piston to adjust, maintain, and/or control a hydraulic pressure that the hydraulic piston exerts on and/or against the tissue."
First, like Barley et al., Willis discloses an RF ablation catheter that also incorporates an ultrasound transducer and teaches explicitly providing the system and device with a RF generator 112 that is connected to the distal most electrode 134 in order to provide a known workable manner of providing the distal electrode tip with ablative energy, see [0039], [0042] and figure 1 for example.
Second, like Barley et al., Belson et al. disclose 1) an elongate RF ablation device, 2) with force sensing built into the tip, and 3) with linearly moving tip and teach providing the tip with a hydraulic piston (see figures 15A and 15B) and a pneumatic pressure line/lumen 178 in order to provide the tip 1) with hydraulic force sensing capabilities (see [0146]) and 2) hydraulic linear tip moving capabilities (see [0113] and figures 15A and 15B) in a known and workable manner.
Therefore the controllable pressure delivery of hydraulic fluid in "pressure line" 178 meets or makes obvious "the force maintenance assembly is configured to control a fluid flow to the hydraulic piston to adjust, maintain, and/or control a hydraulic pressure that the hydraulic piston exerts on and/or against the tissue".
Therefore at the time of the invention it would have been obvious to one of ordinary skill in the art to modify the invention of Barley et al., as taught by Willis, to provide the console (of Barley et al.) with a RF generator that is connected to the distal most electrode in order to provide a known workable manner of providing the distal electrode tip with ablative energy, and as further taught by Belson et al., to provide the tip with a hydraulic piston and a pneumatic pressure line/lumen in order to provide the tip 1) with hydraulic force sensing capabilities hydraulic linear tip moving capabilities in a known and workable manner.
Regarding claim 4, Barley et al. disclose the claimed invention, a hydraulic fluid
("fluid," [0044] and figures 1, and 5-7 for example), wherein the console is configured to
deliver the hydraulic fluid into the piston (see [0020]-[0028], [0044]-[0045], [0066]-
[0069] wherein it is disclosed there is a programmed controller that performs all of the
operational functions which includes the flow of fluid into or towards the piston).
Regarding claims 5-6, Barley et al. disclose the claimed invention, see [0044] and
figure 1.
Regarding claims 7-9, Barley et al. disclose the claimed invention, wherein the force
maintenance module comprises ("compressive collar" 50, "spring element" 60, or
"compressive elements" 70 and the ultrasound transducers shown in the various
embodiments shown in figures 5-7 - along with any backend elements/portions in 111 ).
Regarding claim 10, Barley et al. disclose the claimed invention, see figures 3A-3B.
Regarding claim 11, Barley et al. disclose the claimed invention, wherein the recitation
of the electrode being a mapping electrode as opposed to just an electrode is a recitation
of 1) intended use, 2) language directed to how the device/element is intended to be
employed and/or 3) a functional limitation. A recitation of intended use of the claimed
invention must be evaluated to determine whether the recited purpose or intended use
results in a structural difference ( or, in the case of process claims, manipulative
difference) between the claimed invention and the prior art. If so, the recitation serves to
limit the claim. However, if a prior art structure is capable of performing the intended use
as recited in the preamble, then it meets the claim. A recitation with respect to the manner in which an apparatus is intended to be employed does not impose any structural
limitation upon the claimed apparatus which differentiates it from a prior art reference
disclosing the structural limitations of the claim. In re Pearson, 494 F.2d 1399, 181 USPQ
641 (CCPA 1974); In re Yanush, 477 F.2d 958, 177 USPQ 705 (CCPA 1973); In re
Finsterwalder, 436 F.2d 1028, 168 USPQ 530 (CCPA 1971); In re Casey, 370 F.2d 576,
152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 136 USPQ 458 (CCPA 1963);
Ex parte Masham, 2 USPQ2d 1647 (BdPatApp & Inter 1987). It is well established that a
recitation with respect to the manner in which an apparatus is intended to be employed,
1.e., a functional limitation, does not impose any structural limitation upon the claimed
apparatus which differentiates it from a prior art reference disclosing the structural
limitations of the claim. In re Pearson, 494 F.2d 1399, 181 USPQ 641 (CCPA 1974); In
re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 136
USPQ 458 (CCPA 1963). Where the prior art reference is inherently capable of
performing the function described in a functional limitation, such functional limitation
does not define the claimed apparatus over such prior art reference, regardless of whether
the prior art reference explicitly discusses such capacity for performing the recited
function. In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971). In addition, where
there is reason to believe that such functional limitation may be an inherent characteristic
of the prior art reference, Applicant is required to prove that the subject matter shown in
the prior art reference does not possess the characteristic relied upon. In re Spada, 911
F.2d 705, 15 USPQ2d 1655 (Fed. Cir. 1990); In re King, 801 F.2d 1324, 1327, 231
USPQ 136, 138 (Fed. Cir. 1986); In re Ludtke, 441 F.2d at 664, 169 USPQ at 566 (CCPA
1971).
Regarding claims 12-13, Barley et al. disclose the claimed invention wherein the
electrode 20 is described as a "thin conducting layer supported by the transmission
element" 5, see [0047] and figures 1 and 2. Now given that figure 5 clearly shows the
electrode tip which forms a spherical cavity engages the "transmission element" 5 that
has a matching or mating spherical shape and they therefore the cavity of the electrode tip
"rotatably engages" the spherical member of the "transmission element" 5. Additionally,
the examiner interprets "articulate," 'articulating," and their cognates to be synonymous
with "bend, curve" and their cognates. Barley et al. disclose an articulating tip electrode
in [0059]-[0060] and figure 8.
Regarding claim 14, Barley et al. further disclose the ablation catheter comprises a
contact sensor (comprising "ultrasound transducer," see [0050]-[0051]) configured to
produce a signal representative of the amount of contact between the ablation element
and tissue.
Regarding claim 15-16, Barley et al. disclose the claimed invention, see [0018], [0050]-[0051] for example.
Regarding claim 17, Barley et al. disclose the claimed invention wherein the recitation
of claim 17 is a recitation of 1) intended use, 2) language directed to how the
device/element is intended to be employed and/or 3) a functional limitation. A recitation
of intended use of the claimed invention must be evaluated to determine whether the
recited purpose or intended use results in a structural difference ( or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. However, if a prior art structure is capable of
performing the intended use as recited in the preamble, then it meets the claim. A
recitation with respect to the manner in which an apparatus is intended to be employed
does not impose any structural limitation upon the claimed apparatus which differentiates
it from a prior art reference disclosing the structural limitations of the claim. In re
Pearson, 494 F.2d 1399, 181 USPQ 641 (CCPA 1974); In re Yanush, 477 F.2d 958, 177
USPQ 705 (CCPA 1973); In re Finsterwalder, 436 F.2d 1028, 168 USPQ 530 (CCPA
1971); In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d
937, 136 USPQ 458 (CCPA 1963); Ex parte Masham, 2 USPQ2d 1647 (BdPatApp &
Inter 1987). It is well established that a recitation with respect to the manner in which an
apparatus is intended to be employed, 1.e., a functional limitation, does not impose any
structural limitation upon the claimed apparatus which differentiates it from a prior art
reference disclosing the structural limitations of the claim. In re Pearson, 494 F.2d 1399, 181 USPQ 641 (CCPA 1974); In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967);
In re Otto, 312 F.2d 937, 136 USPQ 458 (CCPA 1963). Where the prior art reference is
inherently capable of performing the function described in a functional limitation, such
functional limitation does not define the claimed apparatus over such prior art reference,
regardless of whether the prior art reference explicitly discusses such capacity for
performing the recited function. In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA
1971). In addition, where there is reason to believe that such functional limitation may be
an inherent characteristic of the prior art reference, Applicant is required to prove that the
subject matter shown in the prior art reference does not possess the characteristic relied
upon. In re Spada, 911 F.2d 705, 15 USPQ2d 1655 (Fed. Cir. 1990); In re King, 801 F.2d
1324, 1327, 231 USPQ 136, 138 (Fed. Cir. 1986); In re Ludtke, 441 F.2d at 664, 169
USPQ at 566 (CCPA 1971). It should be noted the "time resolved imaging" disclosed in
[0013] can meet the claimed intended use/functional recitation.
Regarding claim 18, Barley et al. further disclose the force maintenance !assembly is
configured to compress up to a maximum compression distance, and wherein the
maximum compression distance comprises a distance between 0.1mm and 10mm, see
[0060] where it is disclosed "[i]t is expected that the collar deformation would be at most
0.5 mm off-axis (at the maximum expected contact pressure of .about.SO g)." It should be noted that the maximum compression distance claimed by Applicant does not preclude
off-axis deformations.
Regarding claims 20-21, Barley et al. further disclose the force maintenance I
assembly further comprises at least one displacement sensor (comprising "ultrasound
transducer," see [0050]-[0051]) configured to produce a signal correlating to a travel
distance of the force maintenance assembly. Additionally, the system along with the
sensor (comprising "ultrasound transducer," see [0050]-[0051]), is capable of
determining when the travel distance is equal to a maximum compression distance based
on the sensor signal.
Claim 19 is rejected under 35 U.S.C. 102((a)(l)) as anticipated by Nau, Jr. (U.S. Patent
Application Publication 2010/0179539) or, in the alternative, under 35 U.S.C. 103 as
obvious over Nau, Jr. (U.S. Patent Application Publication 2010/0179539) in view of
Cahill et al. (U.S. Patent Application Publication 2014/0236208).
Regarding claim 19, Nau, Jr. further clearly disclose a locking element (see element Z
in the reproduced figure 1 of Nau, Jr. below) configured to lock the force maintenance
assembly to prevent linear and/or angular movement of the ablation element with respect
to the shaft. Nau, Jr. discloses "movable handle 40 of handle assembly 30 is ultimately
connected to drive assembly 130, which together mechanically cooperate to impart
movement of hydraulic mechanism 200. Movement of hydraulic mechanism 200 causes
jaw members 110 and 120 to move from an open position, wherein the jaw members 110
and 120 are disposed in spaced relation relative to one another, to a clamping or closed
position, wherein the jaw members 110 and 120 cooperate to grasp tissue therebetween,"
see [0022] and figure 1.
But, Nau, Jr. fails to explicitly recite that element Z is a safety or locking mechanism that unless element Z is actuated the movable handle 40 cannot be actuated, and therefore in turn the ablation element cannot translate or rotate with respect to the shaft.
However, it is extremely well known in the medical device with actuating handle arts to provide an element like element Z with locking and safety functions in order to provide safer operation.
As an example, Cahill et al. is a medical device like Nau, Jr. having handle like Nau, Jr.'s with one stationary handle, one movable handle and an element similar to element Z of Nau, Jr. and teach providing the handle having a stationary handle member and a movable handle member ("trigger" 1541, see [0342], [0344] and figure 1) with a "safety" 1591 (much like Nau, Jr.'s element Z) so that the handle/trigger may be selectively actuated in order to provide safety from accidental actuation, see [0344 ]-[0345].
Therefore at the time of the invention it would have been obvious to one of ordinary skill in the art to modify the invention of Nau, Jr., as taught by Cahill et al., to provide the function of locking the handle/trigger actuation in order to provide additional safety.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON F ROANE/Primary Examiner, Art Unit 3792
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