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 11/13/2025 has been entered. Claims 1-3, 6-7, 9-12, 14, 18 & 20 remain pending in the application. Claims 21-24 have been entered.
Response to Arguments
Applicant's arguments with respect to claims 1-3, 6-7, 9-12, 14, 18 & 20 have been considered but are not seen as persuasive, see reasonings below.
Regarding claim 1, Applicant argues that Asher does not explicitly disclose “wherein pre-treating grasped tissue includes shrinking the grasped tissue”. Examiner disagrees. Asher disclose pre-treatment, shrinking the tissue, being done simultaneously with sealing of blood vessels, such that the blood vessels are not seen as the tissue in which is being sealed in Asher, such that, in paragraph [0004], it is disclosed that the heat generated by the current flowing through the tissue and/or between tissues can be useful for sealing blood vessels, therefore, Asher does disclose wherein pre-treating grasped tissue includes shrinking the grasped tissue. Applicant also argues that neither Shelton or Asher disclose wherein applying, after the pre-treatment algorithm is complete, energy to the pre-treated grasped tissue. Examiner disagrees, in Paragraph [0429], it is stated “a lower power level to facilitate surgical treatment in the distal portion after completion of surgical treatment in the proximal portion” therefore, the jaws already have the tissue grasped and are treating a portion of the tissue, while pre-heating the distal electrodes, which it would be obvious to one of the ordinary skill in the art that the electrodes are going to conductively pre-heat the grasped tissue that is in the distal end of the jaws at a low power level. While Shelton is silent on the effects on the tissue at lower power levels, Asher discloses in Paragraph [0005]; that low operating temperatures of RF can be useful for removing, shrinking or sculpting tissue. Shelton also discloses in Paragraph [0372] wherein energy is applied to the electrodes to allow for tissue sealing which is seen as the tissue sealing algorithm which is sperate from the pre-heating, such that when looking at Figure 25B of Shelton, the preheating occurs at a lower power before 100% energy is applied allowing for the tissue sealing. Therefore, examiner stands by the rejection of claim 1 as taught above and in the non-final rejection.
In regards to claims 2, 6-7, 9-12, 14, 18 & 20, Examiner sees claim 1 dependents as being unpatentable over Shelton and Asher as taught by the non-Final action and the reasonings above.
In regards to claim 3, Examiner apologizes for leaving it out of the non-final and has added the rejection in below. Claim 3 is not allowable
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim 1 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites “applying, after the pre-treatment algorithm is complete, energy to the pre-treated grasped tissue”, in applicants specification, it is not stated what the algorithm comprises of only that there is an algorithm and what it can do but never what the algorithm is, which enacts 112a since the claim language requires energy to be applied once the pre-treatment algorithm is complete and it is not stated what exactly the algorithm is.
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 1-3, 8-9, 11-12, 17-18, 21-23 is rejected under 35 U.S.C 103 as being unpatentable over Shelton, IV et al. (US 20190201044) herein referred to as Shelton in view of Asher et al. (US 20180333185) herein referred to as Asher.
Regarding claim 1, Shelton discloses a method of sealing tissue (Paragraph [0212]; wherein the method comprises smoke evacuation, suction of excess fluid, and/or irrigation of the tissue), comprising: grasping tissue between first and second jaw members (Figure 24B); applying energy to the grasped tissue in accordance with a pre-treatment algorithm to pre-treat the grasped tissue in anticipation of tissue sealing (Figure 25B; the electrodes are going to conductively pre-heat the grasped tissue that is in the distal end of the jaws at a low power level), wherein applying the energy includes supplying the energy at an initial voltage and modifying the voltage in accordance with a voltage versus time graph (Paragraph [0370]; wherein all output voltages information can be used to adjust the outputted voltage to the surgical instrument, therefore the initial output voltage can be modified which the voltage versus time graph can be seen in Figure 25B wherein the power on the Y-axis is voltage which is discussed in Paragraph [0372]); and applying, after the pre-treatment algorithm is complete (Figure 25b; wherein the pre-heat ends and the treatment begins), energy to the pre-treated grasped tissue in accordance with a tissue sealing algorithm to seal the pre-treated grasped tissue (Paragraph [0429]; wherein pre-heating occurs prior to treatment such that the electrodes are going to conductively pre-heat the grasped tissue that is in the distal end of the jaws at a low power level; Paragraph [0372]; wherein treatment includes sealing tissue). However, Shelton does not explicitly disclose wherein pre-treating the grasped tissue includes shrinking the grasped tissue.
Asher discloses a method of sealing tissue (Abstract) wherein pre-treating grasped tissue includes shrinking the grasped tissue (Paragraph [0005]; wherein low operating temperatures of RF energy can shrink soft tissue). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the pre-heat temperatures of Shelton to allow for them to be in a range wherein the tissue shrinks. The motivation being RF energy works particularly well on connective tissue, which is primarily comprised of collagen and shrinks when contacted by heat (Asher, Paragraph [0005]).
Regarding claim 2, Shelton in view of Asher discloses the method according to claim 1. Shelton also discloses wherein the tissue sealing algorithm is independent of the pre-treatment algorithm (Figure 25A & 25B; wherein tissue sealing algorithm is seen as independent of pre-treatment algorithm since Figure 25A shows an example of treatment without pre-heat and Figure 25B shows an example with pre-heat therefore pre-heat/treat is not required).
Regarding claim 3, Shelton in view of Asher discloses the method according to claim 1. Shelton also discloses wherein the pre-treatment algorithm is controlled in a first manner and the tissue sealing algorithm is controlled in a second manner different from the first manner (Figure 25b; Paragraph [0429]; wherein the pre-treatment algorithm is controlled in a first manner, 20% power and the tissue sealing algorithm is controlled in a second manner different from the first manner such that the tissue sealing algorithm is controlled at 100% power).
Regarding claim 8, Shelton in view of Asher discloses the method according to claim 1. Shelton also discloses further comprising determining whether the pre-treatment algorithm is complete before applying the energy to the pre-treated grasped tissue in accordance with the tissue sealing algorithm (Paragraph [0426]; wherein the control circuit determines that the tissue impedance has reached a predetermined or dynamically determined threshold, the control circuit may control the generator to power off the proximal electrode pair and instead deliver power to one of the distal electrode pair individually or to both pairs in conjunction).
Regarding claim 9, Shelton in view of Asher discloses the method according to claim 8. Shelton also discloses determining whether the pre-treatment algorithm is complete, wherein the determining also includes comparing an overall impedance change to an impedance change threshold (Paragraph [0426]; wherein the control circuit determines that the tissue impedance has reached a predetermined or dynamically determined threshold, the control circuit may control the generator to power off the proximal electrode pair and instead deliver power to one of the distal electrode pair individually or to both pairs in conjunction).
Regarding claim 11, Shelton discloses a method of sealing tissue (Paragraph [0212]; wherein the method comprises smoke evacuation, suction of excess fluid, and/or irrigation of the tissue), comprising: grasping tissue between first and second jaw members (Figure 24B); determining whether pre-treatment of the grasped tissue is to be performed (Paragraph [0429]; wherein control circuit controls the generator to allow for pre-heat therefore determining if the pre-treatment occurs); in a case where it is determined that pre-treatment of the grasped tissue is to be performed (Figure 25B): applying energy to the grasped tissue in accordance with a pre-treatment algorithm to pre-treat the grasped tissue in anticipation of tissue sealing (Figure 25B), wherein applying the energy includes supplying the energy at an initial voltage and modifying the voltage in accordance with a voltage versus time graph (Paragraph [0370]; wherein all output voltages information can be used to adjust the outputted voltage to the surgical instrument, therefore the initial output voltage can be modified which the voltage versus time graph can be seen in Figure 25B wherein the power on the Y-axis is voltage which is discussed in Paragraph [0372]); and applying, after the pre-treatment algorithm is complete (Figure 25b; wherein the pre-heat ends and the treatment begins), energy to the pre-treated grasped tissue in accordance with a tissue sealing algorithm to seal the pre-treated grasped tissue (Paragraph [0429]; wherein pre-heating occurs prior to treatment such that the electrodes are going to conductively pre-heat the grasped tissue that is in the distal end of the jaws at a low power level; Paragraph [0372]; wherein treatment includes sealing tissue); and in a case where it is not determined that pre-treatment of the grasped tissue is to be performed (Figure 25A): applying energy to the grasped tissue in accordance with the tissue sealing algorithm to seal the grasped tissue (Figure 25A). However, Shelton does not explicitly disclose wherein pre-treating the grasped tissue includes shrinking the grasped tissue.
Asher discloses a method of sealing tissue (Abstract) wherein pre-treating grasped tissue includes shrinking the grasped tissue (Paragraph [0005]; wherein low operating temperatures of RF energy can shrink soft tissue). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the pre-heat temperatures of Shelton to allow for them to be in a range wherein the tissue shrinks. The motivation being RF energy works particularly well on connective tissue, which is primarily comprised of collagen and shrinks when contacted by heat (Asher, Paragraph [0005]).
Regarding claim 12, Shelton in view of Asher discloses the method according to claim 11. Shelton also discloses, wherein the tissue sealing algorithm is independent of the pre-treatment algorithm (Figure 25A & 25B; wherein e tissue sealing algorithm is seen as independent of pre-treatment algorithm since Figure 25A shows an example of treatment without pre-heat and Figure 25B shows an example with pre-heat therefore pre-heat/treat is not required).
Regarding claim 17, Shelton in view of Asher discloses the method according to claim 11. Shelton also discloses further comprising, in the case where it is determined that pre-treatment of the grasped tissue is to be performed (Figure 25B), determining whether the pre-treatment algorithm is complete before applying the energy to the pre-treated grasped tissue in accordance with the tissue sealing algorithm (Paragraph [0426]; wherein the control circuit determines that the tissue impedance has reached a predetermined or dynamically determined threshold, the control circuit may control the generator to power off the proximal electrode pair and instead deliver power to one of the distal electrode pair individually or to both pairs in conjunction).
Regarding claim 18, Shelton in view of Asher discloses the method according to claim 11. Shelton also discloses wherein determining whether the pre- treatment algorithm is complete includes determining an overall impedance change during the pre- treatment (Paragraph [0426]; wherein the control circuit determines that the tissue impedance has reached a predetermined or dynamically determined threshold, the control circuit may control the generator to power off the proximal electrode pair and instead deliver power to one of the distal electrode pair individually or to both pairs in conjunction).
Regarding claim 21, Shelton discloses a method of sealing tissue (Paragraph [0212]; wherein the method comprises smoke evacuation, suction of excess fluid, and/or irrigation of the tissue), comprising: grasping tissue between first and second jaw members (Figure 24B); applying energy to the grasped tissue in accordance with a pre-treatment algorithm to pre-treat the grasped tissue in anticipation of tissue sealing (Figure 25B; the electrodes are going to conductively pre-heat the grasped tissue that is in the distal end of the jaws at a low power level); and applying, after the pre-treatment algorithm is complete (Figure 25b; wherein the pre-heat ends and the treatment begins), energy to the pre-treated grasped tissue in accordance with a tissue sealing algorithm to seal the pre-treated grasped tissue (Paragraph [0429]; wherein pre-heating occurs prior to treatment such that the electrodes are going to conductively pre-heat the grasped tissue that is in the distal end of the jaws at a low power level; Paragraph [0372]; wherein treatment includes sealing tissue). However, Shelton does not explicitly disclose wherein pre-treating the grasped tissue includes shrinking the grasped tissue.
Asher discloses a method of sealing tissue (Abstract) wherein pre-treating grasped tissue includes shrinking the grasped tissue (Paragraph [0005]; wherein low operating temperatures of RF energy can shrink soft tissue). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the pre-heat temperatures of Shelton to allow for them to be in a range wherein the tissue shrinks. The motivation being RF energy works particularly well on connective tissue, which is primarily comprised of collagen and shrinks when contacted by heat (Asher, Paragraph [0005]).
Regarding claim 22, Shelton in view of Asher discloses the method according to claim 21. Shelton also discloses determining whether the pre-treatment algorithm is complete, wherein the determining also includes comparing an overall impedance change to an impedance change threshold (Paragraph [0426]; wherein the control circuit determines that the tissue impedance has reached a predetermined or dynamically determined threshold, the control circuit may control the generator to power off the proximal electrode pair and instead deliver power to one of the distal electrode pair individually or to both pairs in conjunction).
Regarding claim 23, Regarding claim 3, Shelton in view of Asher discloses the method according to claim 21. Shelton also discloses wherein the pre-treatment algorithm is controlled in a first manner and the tissue sealing algorithm is controlled in a second manner different from the first manner (Figure 25b; Paragraph [0429]; wherein the pre-treatment algorithm is controlled in a first manner, 20% power and the tissue sealing algorithm is controlled in a second manner different from the first manner such that the tissue sealing algorithm is controlled at 100% power).
Claims 6-7 & 20 is rejected under 35 U.S.C 103 as being unpatentable over Shelton and Asher in further view of Harper et al. (US 20110144635) herein referred to as Harper.
Regarding Claim 6, Shelton in view of Asher discloses the method according to claim 1. However, Shelton in view of Asher does not explicitly disclose wherein the voltage versus time graph includes a fixed positive voltage ramp.
Harper discloses a method of sealing tissue (Paragraph [0010]) wherein the voltage versus time graph includes a fixed positive voltage ramp (Paragraph [0033]; wherein since voltage is dependent on current (V=IR), therefore if current is being ramped up positively then voltage will also be ramped up at a fixed rate dependent on current while resistance is a constant). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the voltage versus time graph taught by Shelton and Asher to include a fixed positive voltage ramp as taught by Harper. The motivation being by allowing for a controlled fixed positive voltage ramp, it can improve seal quality (Harper, Paragraph [0033]).
Regarding claim 7, Shelton in view of Asher discloses the method according to claim 1. However, Shelton in view of Asher does not explicitly disclose wherein at least a portion of the tissue sealing algorithm adjusts energy output to track an impedance versus time trajectory
Harper discloses a method of sealing tissue (Paragraph [0010]) wherein at least a portion of the tissue sealing algorithm adjusts energy output to track an impedance versus time trajectory (Abstract; Figure 4). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the tissue sealing algorithm taught by Shelton and Asher to track an impedance versus time trajectory as taught by Harper. The motivation being that it is known that tracking impedance versus time can be done by either impedance or voltage therefore they are interchangeable (Harper, Paragraph [0019])
Regarding claim 20, Shelton in view of Asher discloses the method according to claim 11. However, Shelton in view of Asher does not explicitly disclose wherein at least a portion of the tissue sealing algorithm adjusts energy output to track an impedance versus time trajectory
Harper discloses a method of sealing tissue (Paragraph [0010]) wherein at least a portion of the tissue sealing algorithm adjusts energy output to track an impedance versus time trajectory (Abstract; Figure 4). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the tissue sealing algorithm taught by Shelton in view of Asher to track an impedance versus time trajectory as taught by Harper. The motivation being that it is known that tracking impedance versus time can be done by either impedance or voltage therefore they are interchangeable (Harper, Paragraph [0019])
Claims 10 is rejected under 35 U.S.C 103 as being unpatentable over Shelton and Asher in further view of Couture et al. (US 20070173811) herein referred to as Couture.
Regarding Claim 10, Shelton in view of Asher discloses the method according to claim 1. However, Shelton in view of Asher does not explicitly disclose after applying the energy to the grasped tissue in accordance with the pre-treatment algorithm and before applying the energy to the pre-treated, grasped tissue in accordance with the tissue sealing algorithm, implementing a delay period where no energy is applied.
Shelton discloses a method of sealing tissue (Paragraph [0029]; wherein the electrosurgical instrument can be used to seal or cut tissue) wherein after applying the energy to the grasped tissue in accordance with the pre-treatment algorithm and before applying the energy to the pre-treated, grasped tissue in accordance with the tissue sealing algorithm, implementing a delay period where no energy is applied (See annotated Figure 3). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Shelton and Asher to include the time delay taught by Couture. The motivation being to clearly distinguish between each phase of tissue sealing as seen in Figure 3 of Couture to establish the amount of time spent in each phase to make decisions on how to proceed with an algorithm. (Couture, Figure 3; Couture, Paragraph [0042])
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Claim 14 is rejected under 35 U.S.C 103 as being unpatentable over Shelton and Asher in further view of Gaspredes et al. (US 20160310203) herein referred to as Gaspredes.
Regarding Claim 14, Shelton in view of Asher discloses the method according to claim 11 wherein grasped tissue size is determined (Asher, Figure 7, 312). However, Shelton in view of does not explicitly disclose wherein determining whether pre-treatment of the grasped tissue is to be performed is based on a determined size of the grasped tissue.
Gaspredes discloses a vessel sealing system (Figure 1) wherein determining whether pre-treatment of the grasped tissue is to be performed is based on a determined size of the grasped tissue (Paragraph [0095] & [0097]; wherein the sensed amount of tissue can alter the mode of operation, mode 1 containing pre-heating and desiccation which is not seen in mode 3 which is just desiccation). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Shelton and Asher to include the teachings of Gaspredes method. The motivation being to ensure that the tissue size being grasped is getting the proper treatment if it is large (Gaspredes, Paragraph [0095]).
Claim 24 is rejected under 35 U.S.C 103 as being unpatentable over Shelton and Asher in further view of Unger et al. (US 9186200) herein referred to as Unger.
Regarding Claim 24, Shelton in view of Asher disclose the method according to claim 21. However, Shelton in view of Asher does not explicitly disclose wherein a delay period occurs between the pre- treatment algorithm and tissue sealing algorithm, wherein the delay period is about 10 milliseconds to about 2 seconds.
Unger discloses a method of sealing tissue (Figure 6A-B) wherein a delay period occurs between tissue sealing phases (Figure 7, IIIb), wherein the delay period is about 10 milliseconds to about 2 seconds (Column 13, lines 44-47). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the method taught by Shelton in view of Asher to include a delay period as taught by Unger the motivation being. The motivation being to establish the amount of time spent in each phase to make decisions on how to proceed with an algorithm (Unger, Figure 6A-6B).
Conclusion
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 ALYSSA M PAPE whose telephone number is (703)756-5947. The examiner can normally be reached M-F 7:30-5:00.
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794