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 .
Response to Amendment
The amendment filed 12/17/2024 has been entered. Claims 1, 12, 15, and 18 have been amended. Claims 1-2, 4, 7-13, 15, and 18 remain pending on the application.
Response to Arguments
Applicant's arguments filed 12/17/2024 have been fully considered but they are not persuasive.
Regarding Claim 1 and Claim 12, Applicant has amended the claims to specify “determine, based at least in part on the at least one condition of the structure of the collagen within the grasped tissue that the grasped tissue has been sealed; and stop the energy output in response to the determination that the grasped tissue has been sealed” or similar.
Applicant argues that Messerly (US 20190201040 A1) does not disclose determining whether tissue has been sealed by using collagen information, but by frequency-temperature feedback, and asserts that it would not be obvious to use collagen information to determine is a seal is complete from the disclosure of Messerly in view of Wham.
However, Messerly only states that the frequency-temperature feedback control algorithm may be used to determine is sealing is complete (Messerly par [0615] “The frequency-temperature feedback control algorithm may be employed to detect the completion of the vessel transection process. The processor or control circuit of the generator or instrument or both determines 133128 when the vessel transection is complete”).
Messerly further discloses (Messerly par [0653] “In various aspects, an ultrasonic surgical instrument can include a processor or control circuit executing an adaptive ultrasonic blade control algorithm for detecting the composition of the tissue grasped by or at the end effector and controlling operational parameters of the ultrasonic transducer and/or ultrasonic blade accordingly. The tissue composition can include, for example, the ratio of collagen to elastin in the tissue, the stiffness of the tissue, or the thickness of the tissue. The operational parameters controlled or regulated by the adaptive ultrasonic blade control algorithm can include, for example, the amplitude of the ultrasonic blade, the temperature or heat flux of the ultrasonic blade, and so on. The adaptive ultrasonic blade control algorithm can be executed by a control circuit or processor located either in the generator or the surgical instrument”).
Thus, it would be obvious to one of ordinary skill in the art to use the collagen detection algorithm as a control for the sealing of tissue as disclosed by the various embodiments of Messerly.
Claim Interpretation
Claim 1 recites “determine at least one condition of a structure of the collagen”. This is not clearly defined, so par [0032] of the instant Specification is used for “at least one condition of the structure of the collagen”. Par [0032] states “The state, property, and/or other condition of the collagen may include: the presence and/or extent of denaturation of the collagen; the presence and/or extent of migration of collagen fibers; the presence, extent, and/or type of collagen restructuring; the presence, extent, and/or type (reducible or non-reducible) of reformed collagen crosslinks; a phase of the collagen; a phase- change of the collagen; etc.”. Thus, “a condition of the structure of the collagen” is interpreted as any information about collagen beyond identifying the mere presence or amount of collagen.
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.
Claims 1-2, 4, 7-13, 15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Messerly (US 20190201040 A1) in view of Wham (US 20090157072 A1).
Regarding Claim 1, Messerly discloses
An electrosurgical system (Messerly, Fig 22 system (1000), par [0393]), comprising:
an end effector assembly including first and second jaw members each defining an electrically-conductive tissue-contacting surface (Messerly, Fig 22 end effector (1124) jaws (1142a,1142b), par [0395] jaws have electrically conductive tissue contacting surface),
at least one of the first or second jaw members movable relative to the other between a spaced-apart position and an approximated position for grasping tissue between the tissue-contacting surfaces thereof (Messerly, par [0403] grasping tissue),
at least one of the first or second jaw members including a sensor configured to sense at least one property associated with the grasped tissue (Messerly, par [0403] end effector may measure property of tissue);
an electrosurgical generator including a controller and an energy output (Messerly, Fig 22 generator (1100) controller (1110), par [0397]),
the energy output configured to supply electrosurgical energy to the tissue-contacting surface of at least one of the first or second jaw members for conduction through the grasped tissue to seal the grasped tissue (Messerly, par [0406] energy output configured to seal tissue),
the controller configured to:
receive the at least one sensed property (Messerly, par [0411] receiving sensed characteristics of tissue during operation of end effector).
Messerly further discloses an embodiment wherein a controller may
determine at least one condition of collagen within the grasped tissue based upon at least one sensed property (Messerly, Fig 60 controller (130420), par [0669]), wherein at least one condition of the structure of the collagen within the grasped tissue is indicative of changes to the collagen within the grasped tissue resulting from the supply of the electrosurgical energy to seal the grasped tissue (Messerly, par [0667] as heat is applied to the tissue by detecting at what temperature the properties of the tissue change, one can determine the tissue property, par [0673] determined collagen property allows best sealing); determine whether collagen melt temperature has been reached (Messerly par [0670]); as well as determining whether sealing is completed based on sensed parameters (Messerly par [0615]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the collagen-detecting properties of the embodiment of Messerly with the electrosurgical instrument of Messerly, as accurate detection of the properties of collagen within the tissue can improve the planning of electrosurgical sealing (Messerly, par [0533], [0675]). As Messerly discloses both determining whether sealing is complete as well as sensing properties of collagen for purposes of sealing, it would have been obvious to have used the sensed properties of collagen as one of the identifiers to determine whether sealing is complete; as Messerly discloses their embodiments with the intent of alteration and combination (Messerly par [0745]).
Messerly fails to explicitly disclose wherein the controller is configured to
stop the energy output in response to the determination that the at least one condition of the structure of the collagen within the grasped tissue indicates that the grasped tissue has been sealed.
However, Wham discloses a similar electrosurgical system for tissue sealing wherein the controller is further configured to determine whether the grasped tissue is sealed (Wham, par [0057] determining if tissue is sealed), as well as stop the energy output in response to the determination that the grasped tissue has been sealed (Wham par [0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Messerly with sealing determination such as disclosed by Wham and the collagen sensing ability of the embodiment of Messerly with the, as determining the state of the tissue seal is an important criteria for the art of electrosurgery and collagen is an important factor in the sealing of tissue (Wham, par [0008]), and also it is known in the art to cease delivery of electrosurgical energy once a procedure has been completed (Wham par [0009]).
Regarding Claim 12, Messerly discloses
A method of sealing tissue (Messerly, Fig 22, par [0393]), comprising:
supplying electrosurgical energy to at least one jaw member of a pair of jaw members grasping tissue therebetween for conduction of the electrosurgical energy through the grasped tissue to seal the grasped tissue (Messerly, Fig 22 end effector (1124) jaws (1142a,1142b), par [0395] jaws have electrically conductive tissue contacting surface, [0403] grasping tissue);
receiving at least one property associated with the grasped tissue (Messerly, par [0403] end effector may measure property of tissue).
Messerly further discloses
determining at least one condition of collagen within the grasped tissue based upon the at least one sensed property (Messerly, Fig 60 controller (130420), par [0659]), wherein the at least one condition of the structure of the collagen within the grasped tissue is indicative of changes to the collagen within the grasped tissue resulting from the supply of the electrosurgical energy to seal the grasped tissue (Messerly, par [0667] as heat is applied to the tissue by detecting at what temperature the properties of the tissue change, one can determine the tissue property, par [0673] determined collagen property allows best sealing);
determining whether collagen melt temperature has been reached (Messerly par [0670]); as well as determining whether sealing is completed based on sensed parameters (Messerly par [0615]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the collagen-detecting properties of the embodiment of Messerly with the electrosurgical instrument of Messerly, as accurate detection of the properties of collagen within the tissue can improve the planning of electrosurgical sealing (Messerly, par [0533], [0675]). As Messerly discloses both determining whether sealing is complete as well as sensing properties of collagen for purposes of sealing, it would have been obvious to have used the sensed properties of collagen as one of the identifiers to determine whether sealing is complete; as Messerly discloses their embodiments with the intent of alteration and combination (Messerly par [0745]).
Messerly fails to explicitly disclose stopping the supplying of electrosurgical energy in response to the determination that the at least one condition of the structure of the collagen within the grasped tissue indicates that the grasped tissue has been sealed.
However, Wham discloses a similar electrosurgical method for tissue sealing wherein the controller is further configured to determine whether the grasped tissue is sealed (Wham, par [0057] determining if tissue is sealed), as well as stop the energy output in response to the determination that the grasped tissue has been sealed (Wham par [0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the invention of Messerly with sealing determination such as disclosed by Wham and the collagen sensing ability of the embodiment of Messerly with the, as determining the state of the tissue seal is an important criteria for the art of electrosurgery and collagen is an important factor in the sealing of tissue (Wham, par [0008]), and also it is known in the art to cease delivery of electrosurgical energy once a procedure has been completed (Wham par [0009]).
Regarding Claim 2 and Claim 13, Messerly discloses the electrosurgical system of claim 1 and method of claim 12. Messerly further discloses an embodiment wherein the at least one condition of the structure of the collagen includes: denaturation of the collagen, migration of fibers of the collagen, restructuring of the collagen, crosslinking of the collagen, a type of the crosslinking of the collagen, a phase of the collagen, or a phase-change of the collagen (Messerly, par [0667] detecting phase change of collagen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the collagen-detecting properties of the embodiment of Messerly with the electrosurgical instrument of Messerly, as accurate detection of the properties of collagen within the tissue can improve the planning of electrosurgical sealing (Messerly, par [0533], [0675]).
Regarding Claim 4 and Claim 15, Messerly discloses the electrosurgical system of claim 1 and method of claim 12. Messerly further discloses wherein the sensor includes at least one of: an optical sensor, an electrical sensor, a mechanical property sensor, or a chemical sensor (Messerly, par [0403]); and wherein the sensed at least one property is an optical property, an electrical property, a mechanical property, or a chemical property (Messerly, par [0403]).
Regarding Claim 6 and Claim 17, Messerly discloses the electrosurgical system of claim 1 and method of claim 12. Messerly further discloses wherein controlling the energy output includes at least one of: starting, modifying, continuing, or stopping the energy supplied to the at least one tissue-contacting surface (Messerly, par [0411]).
Regarding Claim 7 and Claim 18, Messerly discloses the electrosurgical system of claim 1 and method of claim 12. Messerly further discloses wherein the controller (Messerly, Fig 22 (1110)) includes a storage device (Messerly, par [0410]), as well as determining a sensed tissue property based upon a plurality of inputs (Messerly, par [0411]).
Another embodiment of Messerly discloses a machine learning algorithm (Messerly, par [0737]), and wherein a controller is configured to determine the at least one condition of collagen based upon the at least one sensed property (Messerly, Fig 60 controller (130420), par [0659]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the machine learning and collagen-sensing of the embodiment of Messerly with the electrosurgical instrument of Messerly, as accurate detection of the properties of collagen within the tissue can improve the planning of electrosurgical sealing (Messerly, par [0533], [0675]), and machine learning allows for training and pattern recognition of the device (Messerly, par [0737]).
Regarding Claim 8, Messerly discloses the electrosurgical system of claim 1. Messerly further discloses a housing (Messerly, Fig 22 (1107); and a shaft extending distally from the housing (Messerly, Fig 22 (1127)), wherein the end effector assembly is disposed at a distal end portion of the shaft (Messerly, Fig 22 end effector (1124), par [0395]).
Regarding Claim 9, Messerly discloses the electrosurgical system of claim 8. Messerly further discloses a manual actuator coupled to the housing and configured to move the at least one of the first or second jaw members between the spaced-apart position and the approximated position (Messerly, Fig 22 (1145), par [0395]).
Regarding Claim 10, Messerly discloses the electrosurgical system of claim 1. Messerly does not explicitly disclose first and second shaft members pivotably coupled to one another about a pivot, wherein the end effector assembly extends distally from the pivot, and wherein the first and second shaft members are movable relative to one another to move the at least one of the first or second jaw members between the spaced-apart position and the approximated position.
However, Wham discloses a similar electrosurgical system for tissue sealing comprising first and second shaft members pivotably coupled to one another about a pivot, wherein the end effector assembly extends distally from the pivot, and wherein the first and second shaft members are movable relative to one another to move the at least one of the first or second jaw members between the spaced-apart position and the approximated position (Wham, Fig 5 shaft members (512a,512b) pivot (665) end effector assembly (600), par [0045]).
Regarding Claim 11, Messerly discloses the electrosurgical system of claim 1. Messerly further discloses an embodiment comprising a robotic arm, wherein the end effector assembly extends distally from the robotic arm (Messerly, par [0738-0739]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the robotic arm of the embodiment of Messerly with the electrosurgical instrument of Messerly, as robotic tools are known in the art to assist surgeons during electrosurgical procedures (Messerly, par [0741]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Price (US 9848902 B2) and McFarland (US 20170042604 A1) discuss collagen with regards to sealing tissue. Brustad (US 20120136347 A1) and Baker (US 6083223 A) disclose determining when tissue is sealed. Hancock (US 20160331455 A1) and Odom (US 20070173813 A1) disclose structural changes of collagen during a seal. Gaspredes (US 20160310203 A1) discloses controlling an electrosurgical device based on sensing collagen.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Becton whose telephone number is (571)272-9570. The examiner can normally be reached Tuesday-Friday, 11:00am-5:00pm ET.
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, Joanne Rodden can be reached at (303) 297-4276. 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.
/MATTHEW DAVID BECTON/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794