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 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.
Status of the Claims
The current office action is made responsive to claims filed 02/13/2024.
Claims 1-23 are pending. A complete action on the merits appears below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 12, and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Caplan (US 20150148738 A1).
Regarding claim 1, Caplan teaches a system (Fig. 1; system 10) for ablating target tissue of an airway of a patient during a treatment ([0091]), the system comprising:
an ablation assembly (Fig. 1; ablation device 100), the ablation assembly being configured to be positioned within the airway, the ablation assembly including an active energy emitter ([0100]) configured to contact an airway wall of the airway, and wherein the active energy emitter is configured to deliver energy to the target tissue of the airway to ablate the target tissue, the target tissue being spaced radially outward from the energy emitter ([0025]); and
a controller (Fig. 1; controller 310) configured to control energy delivery from an energy source to the energy emitter, wherein the controller is configured to modify one of power and current of the system to achieve a predetermined output value during at least a portion of a treatment time ([0145]).
Regarding claim 12, the method steps are the same as described as the steps the system is configured to perform and therefore taught in the same way as seen in claims 1 and 23.
Regarding claim 23, Caplan teaches a system (Fig. 1; system 10) for ablating target tissue of an airway of a patient during a treatment ([0091]), the system comprising:
an ablation assembly (Fig. 1; ablation device 100) configured to be positioned within the airway, the ablation assembly including a first electrode configured to contact an airway wall of the airway ([0100]);
a second electrode configured to be positioned outside of the airway ([0126]);
wherein the first electrode is configured to deliver energy to the target tissue of the airway to ablate the target tissue, the target tissue being spaced radially outward from the energy emitter ([0025]), and
wherein the system is configured to measure impedance during the first electrode and second electrode to approximate an airway wall resistance ([0036]); and
a controller (Fig. 1; controller 310) configured to control energy delivery from an energy source to the first electrode, wherein the controller is configured to modify current of the system based on the airway wall resistance to maintain a constant power during at least a portion of a treatment time ([0145]).
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.
Claims 2-3, 6, 13-14, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Caplan (US 20150148738 A1) in view of Gilbert (US 20110028963 A1).
Regarding claim 2, Caplan teaches the system of claim 1.
However, Caplan fails to teach the system wherein the power is dynamically varied during at least a portion of the treatment time to achieve a predetermined current output.
Gilbert teaches an electrosurgical system comprising a generator with a variable power level which is adapted based on a tissue impedance signal (Abstract). This power level being varied to achieve the current output so as to treat the tissue without damage ([0006]).
Gilbert further teaches the system wherein the power is dynamically varied (Fig. 3; the power delivery curve shows a relationship between output power and measured tissue impedance).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teachings of Gilbert into the device of Caplan, as Gilbert teaches the necessity of controlling the output from the electrosurgical generator in order to achieve a desired surgical effect without causing unwanted collateral damage to adjacent tissue.
Regarding claim 3, Gilbert further teaches the system of claim 2, wherein the power is varied within a maximum power level (Fig. 5; higher power region 161).
Regarding claim 6, Gilbert further teaches the system of claim 1, wherein the controller is configured to dynamically vary the power of the energy source to achieve a current target for a first portion of the treatment time, and upon expiration of the treatment time, the controller is configured to dynamically vary the current of the energy source to achieve a power target for a second portion of the treatment time (Fig. 3; the target power curve includes an initial constant current portion 110, and an intermediate constant power portion 112).
Regarding claims 13-14 and 17, the method steps are the same as described as the steps the system is configured to perform and therefore taught in the same way as seen in claims 2-3 and 6.
Claims 7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Caplan (US 20150148738 A1) in view of Hareyama (US 6511476 B2).
Regarding claim 7, Caplan as modified teaches the system of claim 6.
However, Caplan as modified fails to teach the system wherein a sample of a lowest impedance value during the first portion of the treatment time is measured, and wherein the system is configured to indicate a warning or stop delivering energy if an impedance measured during the second portion of the treatment time exceeds a sum of the lower impedance value from the first portion of time and a predetermined impedance value.
Hareyama teaches an electrosurgical apparatus for supplying HF power to an instrument to dissect tissue (Abstract).
Hareyama further teaches that wherein a sample of a lowest impedance value during the first portion of the treatment time is measured, and wherein the system is configured to indicate a warning or stop delivering energy if an impedance measured during the second portion of the treatment time exceeds a sum of the lower impedance value from the first portion of time and a predetermined impedance value (Col. 5, Lines 35-55 & Fig. 3 shows the relevant relationship between the impedance condition and the output value when the condition is met).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teachings of Hareyama into the device of Caplan/Gilbert as Hareyama shows the known relevant relationship between the impedance condition and the output value, specifically with relation to the impedance condition being met.
Regarding claim 18, the method steps are the same as described as the steps the system is configured to perform and therefore taught in the same way as seen in claim 7.
Claims 8-9, 11, 19-20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Caplan (US 20150148738 A1) in view of Francischelli (US 20030171745 A1).
Regarding claim 8, Caplan as modified teaches the system of claim 1.
However, Caplan as modified fails to teach the system wherein the controller is configured to hold one of power or current constant for a first portion of the treatment time, wherein during a second portion of the treatment time, the controller is configured to calculate a percent impedance slope by:
%
i
m
p
e
d
a
n
c
e
s
l
o
p
e
=
Z
o
-
Z
a
c
u
a
t
l
t
o
-
t
a
c
t
u
a
l
*
100
%
in which ZO is an impedance at a beginning of the treatment time, and Zactual is an impedance at a time t during the treatment time, and tO – tactual is the time elapsed from the beginning of the treatment time, and wherein the controller is configured to vary the power or current to maintain the % impedance slope within a predetermined range.
Francischelli teaches a system and method for creating lesions and assessing their completeness (Abstract).
Francischelli further teaches the system wherein the controller is configured to hold one of power or current constant for a first portion of the treatment time, wherein during a second portion of the treatment time, the controller is configured to calculate a percent impedance slope by: % 𝑖𝑚𝑝𝑒𝑑𝑎𝑛𝑐𝑒 𝑠𝑙𝑜𝑝𝑒 = (𝑍𝑜−𝑍𝑎𝑐𝑢𝑎𝑡𝑙 𝑡𝑜−𝑡𝑎𝑐𝑡𝑢𝑎𝑙 ) ∗100% in which Zo is an impedance at a beginning of the treatment time, and Actual is an impedance at a time t during the treatment time, and to - tactual is the time elapsed from the beginning of the treatment time, and wherein the controller is configured to vary the power or current to maintain the % impedance slope within a predetermined range ([0051] discusses initial selected power level as being either maintained or increased to a second power level in response to changes in the detected impedance occurring during the ablation).
Regarding claim 9, Francischelli further teaches the system of claim 8, wherein impedance is measured during the first portion of the treatment time, and wherein the system is configured to indicate a warning or stop delivering energy if a predetermined impedance threshold is met or exceeded during the first portion of the treatment time ([0051] discusses the rapid dZ/dt as triggering the power to be turned off).
Regarding claim 11, Francischelli further teaches the system of claim 8, wherein the system is configured to indicate a warning or stop delivering energy if a predetermined % impedance slope value is met or exceeded during the second portion of the treatment time ([0051] discusses the rapid dZ/dt as triggering the power to be turned off).
Regarding claims 19-20 and 22, the method steps are the same as described as the steps the system is configured to perform and therefore taught in the same way as seen in claims 8-9 and 11.
Claims 10 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Caplan (US 20150148738 A1) in view of Francischelli (US 20030171745 A1) further in view of Hareyama (US 6511476 B2).
Regarding claim 10, Caplan as modified teaches the system of claim 9.
However, Caplan as modified fails to teach the system wherein a sample of a lowest impedance value during the first portion of the treatment time is measured, and wherein the system is configured to indicate a warning or stop delivering energy if an impedance measured during the second portion of the treatment time exceeds a sum of the lower impedance value from the first portion of time and a predetermined impedance value.
Hareyama teaches an electrosurgical apparatus for supplying HF power to an instrument to dissect tissue (Abstract).
Hareyama further teaches that wherein a sample of a lowest impedance value during the first portion of the treatment time is measured, and wherein the system is configured to indicate a warning or stop delivering energy if an impedance measured during the second portion of the treatment time exceeds a sum of the lower impedance value from the first portion of time and a predetermined impedance value (Col. 5, Lines 35-55 & Fig. 3 shows the relevant relationship between the impedance condition and the output value when the condition is met).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to incorporate the teachings of Hareyama into the device of Caplan/Gilbert as Hareyama shows the known relevant relationship between the impedance condition and the output value, specifically with relation to the impedance condition being met.
Regarding claim 21, the method steps are the same as described as the steps the system is configured to perform and therefore taught in the same way as seen in claim 10.
Allowable Subject Matter
Claims 4-5 and 15-16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The following is an examiner’s statement of reasons for allowance: the use of a controller which regulates current based on impedance measurements, or changes in impedance measurement, is known in the art, as is taught by Cadouri (US 20150112321 A1). However, Cadouri does not teach this current as being specifically held constant if a predetermined percent impedance drop target is reached before a current target is reached. Further the use of applied power being controlled to achieve a rate of change in impedance during a treatment time, is known in the art, as is taught by Gaspredes (US 20160310203 A1). However, Gaspredes does not teach varying power to achieve a current target if the predetermined impedance drop target is not met during the treatment time.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-23 are rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. US 11896294 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US 11896294 B2 anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSAY REGAN LANCASTER whose telephone number is (571)272-7259. The examiner can normally be reached Monday-Thursday 8-4 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/L.R.L./Examiner, Art Unit 3794