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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements is being considered by the examiner.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-8, 12-18 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cosman (US Patent No 20150320481).
Regarding claim 1, Cosman teaches a method for operating a hemorrhoid treatment device comprising: coupling a hemorrhoid treatment device (ablation treatment device, [0085]) to a computing device with a cable (see the computer/generator device 100, which is connected via cable 154, [0099]), with a probe electrode coupled to the hemorrhoid treatment device (see electrode probe 150, [0099]); placing a grounding pad in contact with a patient to be treated for hemorrhoids, with the grounding pad to be coupled to the hemorrhoid treatment device (see the ground pads 121-124 connected to the treatment device via cables 121a, [0106]); providing anesthesia to the patient (see in which the active tip member 151 contains a fluid reservoir that can be used for anesthesia, [0100]); setting a level of current to be applied by the hemorrhoid treatment device, with the level of current exceeding a level that causes discomfort to the patient (see [0086], in which the generator may produce a high frequency current output as to cause HF ablation, thereby exceeding a discomfort level of output); and operating the hemorrhoid treatment device to perform the following: deliver an output voltage to the probe electrode coupled to the hemorrhoid treatment device, with the probe electrode to contact the hemorrhoid being treated (see in which the generator device 100 is capable of outputting a high level of voltage output to the electrode probe 150, [0087]), and adjust the output voltage to compensate for fluctuations in body resistance of the patient so that the set level of current being delivered to the hemorrhoid is consistent (see in which the voltage and the current measurement device MV1 and ME1 use the measured voltage and current to adjust the power and voltage sent to the electrode 650 as to achieve ideal treatment delivery which can result in constant current flow, [0179]).
Regarding claim 2, Cosman teaches the method according to claim 1 wherein the set level of current being delivered to the hemorrhoid is a monopolar direct current (see in which the generator system has ablation configurations for monopolar energy delivery, [0042]).
Regarding claim 3, Cosman teaches the method according to claim 1 wherein the set level of current is within a range of 12-16 mA (see in which the set current application may fall between 0 – 400 mA, [0087], therefore enclosing the claimed range).
Regarding claim 4, Cosman teaches the method according to claim 1 wherein the set level of current is equal to or greater than 16 mA (see in which the set current application may fall between 0 – 400 mA, [0087], therefore enclosing the claimed range).
Regarding claim 5, Cosman teaches the method according to claim 1 wherein the set level of current is applied to the hemorrhoid within 5 seconds or less upon contact with the probe electrode (see in which the multiple steps for delivering current to the treatment area occur over a 1 second duration, [0108], therefore falling within 5 seconds or less).
Regarding claim 6, Cosman teaches the method according to claim 1 wherein the hemorrhoid treatment device comprises a voltage output configured to deliver the output voltage to the probe electrode (see in which the generator device 100 is capable of outputting a high level of voltage output to the electrode probe 150, [0087]), and a variable resistance network coupled to the voltage output (see in which there is a switch SG1 that has an active circuit element which produces an adjustable resistance network which can be adjusted by the controller in response to the voltage flowing throughout, [0179]), and operating the hemorrhoid treatment device comprises: changing resistance of the variable resistance network to adjust the output voltage to compensate for the fluctuations in body resistance of the patient so that the set level of current is consistently delivered to the hemorrhoid (see in which the voltage and the current measurement device MV1 and ME1 use the measured voltage and current to adjust the power and voltage sent to the electrode 650 as to achieve ideal treatment delivery which can result in constant current flow, this may be used in conjunction with the adjustable resistance element via the controller, [0179]).
Regarding claim 7, Cosman teaches the method according to claim 1 wherein the fluctuations in body resistance of the patient is based on an interface between the grounding pad and the patient (see in [0106], in which it is described how the ground pads 121 adhere to the patient, and based on the adhesion, this is indicative of changes in the impedance and resistance to the system).
Regarding claim 8, Cosman teaches the method according to claim 1 wherein the cable coupling the hemorrhoid treatment device to the computing device comprises an inline connector junction, with the grounding pad being coupled to the hemorrhoid treatment device via the inline connector junction (see in which the computer/generator 100 has an interface with different cable jacks G1-G4 as well as E1, in which this jack interface is seen as the analogous in-line connecter which connects the grounding pads 121 to the probe treatment device 150, seen in fig 1A).
Regarding claim 12, Cosman teaches a method for operating a hemorrhoid treatment device comprising: coupling a hemorrhoid treatment device (ablation treatment device, [0085]) to a computing device with a cable (see the computer/generator device 100, which is connected via cable 154, [0099]), with a probe electrode coupled to the hemorrhoid treatment (see electrode probe 150, [0099]); placing a grounding pad in contact with a patient to be treated for hemorrhoids, with the grounding pad to be coupled to the hemorrhoid treatment device (see the ground pads 121-124 connected to the treatment device via cables 121a, [0106]); sedating the patient (see in which the active tip member 151 contains a fluid reservoir that can be used for anesthesia, [0100]); setting a level of current to be applied by the hemorrhoid treatment device, with the level of current exceeding a level that causes discomfort to the patient (see [0086], in which the generator may produce a high frequency current output as to cause HF ablation, thereby exceeding a discomfort level of output); and operating the hemorrhoid treatment device to perform the following: deliver an output voltage to the probe electrode coupled to the hemorrhoid treatment device, with the probe electrode to contact the hemorrhoid being treated (see in which the generator device 100 is capable of outputting a high level of voltage output to the electrode probe 150, [0087]), and adjust the output voltage to compensate for fluctuations in body resistance of the patient so that the set level of current being delivered to the hemorrhoid is consistent (see in which the voltage and the current measurement device MV1 and ME1 use the measured voltage and current to adjust the power and voltage sent to the electrode 650 as to achieve ideal treatment delivery which can result in constant current flow, [0179]).
Regarding claim 13, Cosman teaches the method according to claim 12 wherein the set level of current being delivered to the hemorrhoid is a monopolar direct current (see in which the generator system has ablation configurations for monopolar energy delivery, [0042]).
Regarding claim 14, Cosman teaches the method according to claim 12 wherein the set level of current is within a range of 12-16 mA (see in which the set current application may fall between 0 – 400 mA, [0087], therefore enclosing the claimed range).
Regarding claim 15, Cosman teaches the method according to claim 12 wherein the set level of current is equal to or greater than 16 mA (see in which the set current application may fall between 0 – 400 mA, [0087], therefore enclosing the claimed range).
Regarding claim 16, Cosman teaches the method according to claim 12 wherein the set level of current is applied to the hemorrhoid within 5 seconds are less upon contact with the probe electrode (see in which the multiple steps for delivering current to the treatment area occur over a 1 second duration, [0108], therefore falling within 5 seconds or less).
Regarding claim 17, Cosman teaches the method according to claim 12 wherein the hemorrhoid treatment device comprises a voltage output configured to deliver the output voltage to the probe electrode (see in which the generator device 100 is capable of outputting a high level of voltage output to the electrode probe 150, [0087]), and a variable resistance network coupled to the voltage output (see in which there is a switch SG1 that has an active circuit element which produces an adjustable resistance network which can be adjusted by the controller in response to the voltage flowing throughout, [0179]), and operating the hemorrhoid treatment device comprises: changing resistance of the variable resistance network to adjust the output voltage to compensate for the fluctuations in body resistance of the patient so that the set level of current is consistently delivered to the hemorrhoid (see in which the voltage and the current measurement device MV1 and ME1 use the measured voltage and current to adjust the power and voltage sent to the electrode 650 as to achieve ideal treatment delivery which can result in constant current flow, this may be used in conjunction with the adjustable resistance element via the controller, [0179]).
Regarding claim 18, Cosman teaches the method according to claim 12 wherein the cable coupling the hemorrhoid treatment device to the computing device comprises an inline connector junction, with the grounding pad being coupled to the hemorrhoid treatment device via the inline connector junction (see in which the computer/generator 100 has an interface with different cable jacks G1-G4 as well as E1, in which this jack interface is seen as the analogous in-line connecter which connects the grounding pads 121 to the probe treatment device 150, seen in fig 1A).
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(s) 9-11, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cosman (US Patent No 20150320481) in view of Cohen (US Patent No 20050108057).
Regarding claim 9, Cosman teaches the method according to claim 1.
Cosman does not teach wherein the computing device includes operational treatment software in communications with a backend server, the method comprises the physician logging into the operation treatment software before operating the operating the hemorrhoid treatment device.
However, the analogous medical device management system taught by Cohen does disclose a computing device includes operational treatment software in communications with a backend server (see from Cohen, [0184], in which the medical device contains operation software which is in communication with a variety of different servers), the method comprises the physician logging into the operation treatment software before operating the operating the hemorrhoid treatment device (see from Cohen, [0147], see in which the server contains an authentication processor 1130 for identifying a user for operation).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the system and methods for operating on a hemorrhoid treatment area taught by Cosman with that of the backend server communication and software system taught by Cohen, as Cohen proves that backend servers and systems to communicate and operate with medical treatment devices are well known and obvious to those skilled in the art, as well as allowing for a more streamlined and automated treatment process as taught by Cohen, [0184].
Regarding claim 10, the combination teaches the method according to claim 9 wherein the backend server verifies that the physician is registered to use the hemorrhoid treatment device (from Cohen, [0168], see in which the server software has a security system for verifying whether the user is capable of using the medical device or not).
Regarding claim 11, the combination teaches the method according to claim 9 comprises: monitoring usage of the hemorrhoid treatment device via the operational treatment software; and generating a treatment summary report via the operational treatment software based on the monitored usage of the hemorrhoid treatment device (see from Cohen, [0171], in which the medical device management system 1000 is in communication with the server to accurately monitor and manage the use of the medical device ad well as present summary data after use).
Regarding claim 19, Cosman teaches the method according to claim 12.
Cosman does not teach wherein the computing device includes operational treatment software in communications with a backend server, the method comprises the physician logging into the operation treatment software before operating the operating the hemorrhoid treatment device.
However, the analogous medical device management system taught by Cohen does disclose a computing device includes operational treatment software in communications with a backend server (see from Cohen, [0184], in which the medical device contains operation software which is in communication with a variety of different servers), the method comprises the physician logging into the operation treatment software before operating the operating the hemorrhoid treatment device (see from Cohen, [0147], see in which the server contains an authentication processor 1130 for identifying a user for operation).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the system and methods for operating on a hemorrhoid treatment area taught by Cosman with that of the backend server communication and software system taught by Cohen, as Cohen proves that backend servers and systems to communicate and operate with medical treatment devices are well known and obvious to those skilled in the art, as well as allowing for a more streamlined and automated treatment process as taught by Cohen, [0184].
Regarding claim 20, the combination teaches the method according to claim 18 comprises: monitoring usage of the hemorrhoid treatment device via the operational treatment software; and generating a treatment summary report via the operational treatment software based on the monitored usage of the hemorrhoid treatment device (see from Cohen, [0171], in which the medical device management system 1000 is in communication with the server to accurately monitor and manage the use of the medical device ad well as present summary data after use).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
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/KYLE M. BROWN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
