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 (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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 15 January 2025 has been entered.
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.
Claims 11, 16, 21, 27 and 32, are rejected under 35 U.S.C. 103 as being unpatentable over Dumbauld (US 2005/0113827) in view of Twomey (US 2012/0283727) and Hafner (US 2008/0215048).
Regarding claim 11, 16 and 32, Dumbauld discloses a surgical instrument (fig. 4) with a housing (20 as in fig. 1A) and end effector assembly having two movable jaws for grasping tissue (110, 120) each with an electrode ([0074], see fig. 6B). The jaws are operated by a manually actuated handle (40) through a drive assembly (the mechanisms between the handle and the jaws). The movable handle is moved toward a fixed handle (fig. 1A). The instrument further comprises a deployable element movable relative to the end effector assembly (154). Since the deployable element and the jaws are independently movable, they can be moved at the same time. Dumbauld teaches that the jaw electrodes are prevented from energization regardless of the position of the jaws when the deployable element is extended ([0086]), that is, not retracted. Energy is delivered from the deployable element in a monopolar manner ([0080]). Dumbauld does not disclose the use of an output to indicate the jaws electrodes can be energized. However, using a wide range of indicators, including audible indicators, to let a user know the jaws are closed such that jaw electrodes can be safely energized is common in the art, such as taught by Twomey ([0054]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the instrument of Dumbauld to include an audible indicator for the jaws-approximated position as taught by Twomey that would produce the predictable result of allowing a user to know that the jaws are in fact closed. Neither Dumbauld nor Twomey disclose that the movable handle has two compressed positions, one for closing the jaw and a further one for energizing the electrode. However, automatically energizing electrodes is very common in the art and more generally automating a manual process has been held to be an obvious modification (MPEP 2144.04(III)). In fact, Twomey specifically teaches that energy activation can be performed by a distinct button or when the jaws are closed by moving the movable handle ([0035]), a teaching that these are functionally equivalent mechanisms for applying energy with a forceps device (MPEP 2144.06). Hafner discloses a forceps device with two compressed positions (figs. 7-8): one for closing the jaws (defined by 80) and a second for applying energy to electrodes on the jaws when the movable handle contacts a switch (110, [0076]). Therefore, before the application was filed, it would have been obvious to modify the instrument of Dumbauld-Twomey to include any commonly known mechanism of applying energy to the electrodes, including the two compressed handle positions as taught by Hafner, that would produce the predictable result of allowing a user to treat tissue in a desired manner.
Regarding claim 21 and 27 the instrument of Dumbauld-Twomey-Hafner has all the features discussed above with respect to claims 11, 12 and 16 and is capable of the functional limitations described in the claims. The energizable element is the same as the deployable element. Further, the application of bipolar energy between jaws will treat tissue in a different manner than the application of monopolar energy from the deployable element
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Dumbauld, Twomey and Hafner, further in view of Livneh (US 2009/0157074).
Regarding claims 13-15, Dumbauld further discloses the deployable element is deployed by interaction with a manual second mechanical input (450), but does not specifically disclose the use of a gear assembly or a rotatable actuator. However, the fact that Dumbauld does not show the interior of the housing at all suggests that the particular mechanisms used to allow a user to transmit force to the element is within the level of ordinary skill in the art to choose, and Applicant has not provided any evidence that the use of gears is critical or produces an unexpected result. Further, there is no evidence it makes any meaningful difference whether the actuator is a slide, button, switch, knob, lever or other type of commonly known actuation element. Livneh discloses an instrument which uses a rotatable actuator on a housing to actuate a tool (154, fig. 1). Livneh does not disclose the use of gears but gears are well-known to those of ordinary skill in the art. It has been held that the simple substitution for one known element for another is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to provide the instrument of Dumbauld-Twomey-Hafner to include any commonly known mechanism of moving a tool relative to jaws, including a manually rotatable actuator as taught by Livneh, connected by any commonly known force-transmission elements including gears to the tool, that would produce the predictable result of allowing a user to actuate the deployable element.
Claims 17-20 and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Dumbauld, Twomey and Hafner, further in view of Sugalski (US 2012/0022583).
Regarding claims 17-20, 28 and 29, the instrument of Dumbauld-Twomey-Hafner does not disclose the specific mechanism which prevents energy from being delivered to the jaw electrodes when the deployable element is deployed. However, switches border on ubiquitous in the electrical arts and there is no evidence that using a mechanical switch with at least two states is critical or produces unexpected results. Sugalski discloses a forceps device that uses a mechanical switch with two states to prevent energy from being delivered when energy delivery is unwanted based on the position of part of the device ([0057], figs. 6-7). Therefore, before the application was filed, it would have been obvious to modify the instrument of Dumbauld-Twomey-Hafner to include a switch such as taught by Sugalski to produce the predictable result of ensuring that energy is not delivered to the jaw electrodes when the deployable element is deployed.
Regarding claim 30, the instrument of Dumbauld-Twomey-Hafner does not include two switches, one for the jaw electrodes and the other for the energizable/deployable element. However, it is still true that switches are ubiquitous in the art and well within the level of ordinary skill in the art. Further, Dumbauld specifically contemplates different switches for the energy-delivering elements ([0085], [0087]). Therefore, before the application was filed, it would have been obvious to provide the instrument of Dumbauld-Twomey-Hafner-Sugalski with any number of switches corresponding to any number of energy-delivering elements that would produce the predictable result of allowing a user to control energy delivery in a desired manner.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Dumbauld, Twomey and Hafner, further in view of Falkenstein (US 2009/0248022).
Regarding claim 31, the instrument of Dumbauld-Twomey-Hafner does not disclose the use of a clicker. However, physical noise makers are common in this and many technology areas and there is no evidence a clicker is critical or produces an unexpected result. Falkenstein disclose an electrosurgical forceps device with an indicator and teaches there are numerous types of indicators including a clicker ([0160]). Therefore, before the application was filed, it would have been obvious to provide any indicator of movement in the instrument of Dumbauld-Twomey-Hafner by using two elements (i.e. “tabs” or “teeth”) that physically interact to produce a click sound such as taught by Falkenstein, including the indicator provided when the handle is moved between positions, that would produce the predictable result of allowing a user to be informed of information relevant to the safe and effective treatment of tissue.
Claims 11, 16, 21, 27 and 32, are rejected under 35 U.S.C. 103 as being unpatentable over Dumbauld in view of Twomey, Hafner, and Dodde (US 2007/0179489).
Regarding claim 11, 16 and 32, Dumbauld discloses a surgical instrument (fig. 4) with a housing (20 as in fig. 1A) and end effector assembly having two movable jaws for grasping tissue (110, 120) each with an electrode ([0074], see fig. 6B). The jaws are operated by a manually actuated handle (40) through a drive assembly (the mechanisms between the handle and the jaws). The movable handle is moved toward a fixed handle (fig. 1A). The instrument further comprises a deployable element movable relative to the end effector assembly (154). Dumbauld teaches that the jaw electrodes are prevented from energization regardless of the position of the jaws when the deployable element is extended ([0086]), that is, not retracted. Energy is delivered from the deployable element in a monopolar manner ([0080]). Dumbauld does not disclose that the jaws and the monopolar element mechanically joined such that the jaws are closed when the element is extended. However, Dumbauld does disclose several configurations of the relationship between the jaws and the element including extending the jaws and element independently ([0083]) and extending the element after closing the jaws ([0082]). This suggests that the relationship between the element and the jaws is well within the level of ordinary skill in the art to determine and that variations do not produce an unexpected result. Further, operating the functions of a forceps sequentially or simultaneously is common in the art and there is no evidence that either produces an unexpected result. Dodde, for example, discloses a forceps device that includes an end effector having two functional elements, and teaches that the functional elements can be linked by a single actuator so that the functions are performed simultaneously or, as in Dumbauld, they can have separate actuators to allow independent function ([0034]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the forceps of Dumbauld to include simultaneous activation of forceps functions as taught by Dodde, including extending the element and closing the jaws, that would produce the predictable result of allowing a user to operate the functions of the forceps. Dumbauld does not disclose the use of an output to indicate the jaws electrodes can be energized. However, using a wide range of indicators, including audible indicators, to let a user know the jaws are closed such that jaw electrodes can be safely energized is common in the art, such as taught by Twomey ([0054]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the instrument of Dumbauld to include an audible indicator for the jaws-approximated position as taught by Twomey that would produce the predictable result of allowing a user to know that the jaws are in fact closed. Neither Dumbauld nor Twomey disclose that the movable handle has two compressed positions, one for closing the jaw and a further one for energizing the electrode. However, automatically energizing electrodes is very common in the art and more generally automating a manual process has been held to be an obvious modification (MPEP 2144.04(III)). In fact, Twomey specifically teaches that energy activation can be performed by a distinct button or when the jaws are closed by moving the movable handle ([0035]), a teaching that these are functionally equivalent mechanisms for applying energy with a forceps device (MPEP 2144.06). Hafner discloses a forceps device with two compressed positions (figs. 7-8): one for closing the jaws (defined by 80) and a second for applying energy to electrodes on the jaws when the movable handle contacts a switch (110, [0076]). Therefore, before the application was filed, it would have been obvious to modify the instrument of Dumbauld-Twomey to include any commonly known mechanism of applying energy to the electrodes, including the two compressed handle positions as taught by Hafner, that would produce the predictable result of allowing a user to treat tissue in a desired manner.
Regarding claim 21 and 27 the instrument of Dumbauld-Twomey-Hafner has all the features discussed above with respect to claims 11, 12 and 16 and is capable of the functional limitations described in the claims. The energizable element is the same as the deployable element. Further, the application of bipolar energy between jaws will treat tissue in a different manner than the application of monopolar energy from the deployable element
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Dumbauld, Twomey, Hafner and Dodde, further in view of Livneh.
Regarding claims 13-15, Dumbauld further discloses the deployable element is deployed by interaction with a manual second mechanical input (450), but does not specifically disclose the use of a gear assembly or a rotatable actuator. However, the fact that Dumbauld does not show the interior of the housing at all suggests that the particular mechanisms used to allow a user to transmit force to the element is within the level of ordinary skill in the art to choose, and Applicant has not provided any evidence that the use of gears is critical or produces an unexpected result. Further, there is no evidence it makes any meaningful difference whether the actuator is a slide, button, switch, knob, lever or other type of commonly known actuation element. Livneh discloses an instrument which uses a rotatable actuator on a housing to actuate a tool (154, fig. 1). Livneh does not disclose the use of gears but gears are well-known to those of ordinary skill in the art. It has been held that the simple substitution for one known element for another is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the instrument of Dumbauld to include any commonly known mechanism of moving a tool relative to jaws, including a manually rotatable actuator as taught by Livneh, connected by any commonly known force-transmission elements including gears to the tool, that would produce the predictable result of allowing a user to actuate the deployable element.
Claims 17-20 and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Dumbauld, Twomey, Hafner and Dodde, further in view of Sugalski (US 2012/0022583).
Regarding claims 17-20, 28 and 29, the instrument of Dumbauld does not disclose the specific mechanism which prevents energy from being delivered to the jaw electrodes when the deployable element is deployed. However, switches border on ubiquitous in the electrical arts and there is no evidence that using a mechanical switch with at least two states is critical or produces unexpected results. Sugalski discloses a forceps device that uses a mechanical switch with two states to prevent energy from being delivered when energy delivery is unwanted based on the position of part of the device ([0057], figs. 6-7). Therefore, before the application was filed, it would have been obvious to further modify the instrument of Dumbauld to include a switch such as taught by Sugalski to produce the predictable result of ensuring that energy is not delivered to the jaw electrodes when the deployable element is deployed.
Regarding claim 30, the instrument of Dumbauld does not include two switches, one for the jaw electrodes and the other for the energizable/deployable element. However, it is still true that switches are ubiquitous in the art and well within the level of ordinary skill in the art. Further, Dumbauld specifically contemplates different switches for the energy-delivering elements ([0085], [0087]). Therefore, before the application was filed, it would have been obvious to further modify the instrument of Dumbauld with any number of switches corresponding to any number of energy-delivering elements that would produce the predictable result of allowing a user to control energy delivery in a desired manner.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Dumbauld, Twomey, Hafner and Dodde, further in view of Falkenstein
Regarding claim 31, the instrument of Dumbauld-Twomey-Hafner does not disclose the use of a clicker. However, physical noise makers are common in this and many technology areas and there is no evidence a clicker is critical or produces an unexpected result. Falkenstein disclose an electrosurgical forceps device with an indicator and teaches there are numerous types of indicators including a clicker ([0160]). Therefore, before the application was filed, it would have been obvious to provide any indicator of movement in the instrument of Dumbauld by using two elements (i.e. “tabs” or “teeth”) that physically interact to produce a click sound such as taught by Falkenstein, including the indicator provided when the handle is moved between positions, that would produce the predictable result of allowing a user to be informed of information relevant to the safe and effective treatment of tissue.
Response to Arguments
Applicant's arguments filed 15 January 2025 have been fully considered but they are not persuasive. Applicant argues that Dumbauld does not disclose the step of closing the jaws when the deployable element is deployed. But these are not method claims that recite what a device does, they are apparatus claims that recite what a device is (MPEP 2144(II)), and the claims only recite that the jaws are closed when the deployable element is deployed. This can easily be accomplished by an operator where, as Dumbauld teaches, the jaws and deployable element are independently movable. Further, the claims recite no specific structural elements that would mechanically join these functions such that movement of the deployable element necessarily results in movement of the jaws (or vice versa).
However, since Applicant filed an RCE to have these amendments considered, a second rejection has been presented as though the claims recited some mechanical relationship between the jaws and the deployable element.
Further in the interest of compact prosecution, it may be argued in the future that it would be obvious to provide a forceps such as Dumbauld with a mode selector to allow a user to set which functions of the forceps are actuated in which order, where mode selectors are common in the art (see Conclusion below for example).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding an electrosurgical device with functional elements and a mode switch to allow the functional elements to be used in a simultaneous mode, a sequential mode and an individual mode, see paragraph [0026] of US 2003/0212390 to Chen.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
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, Joseph Stoklosa can be reached on 571-272-1213. 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.
/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
Prosecution Insights