DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/02/2025 (“12/02/25 Amendment") has been entered, and fully considered.
Response to Amendment
3. In the 12/02/25 Amendment, claims 1 & 11 were amended. No claims were cancelled, or newly added. Therefore, claims 1-15 remain pending in the application.
4. The 12/02/25 Amendment has overcome the rejections under §§ 102 & 103 previously set forth in the Final Office Action mailed 09/04/25 (“09/04/25 Action”).
5. New grounds of rejection under §§ 102 & 103 are set forth herein, necessitated by Applicant’s Amendment.
Claim Rejections - 35 USC § 102
6. 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.
7. Claims 1, 2, 4-6, 8, 9, 11, 12, & 14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent Application Publication No. 2021/0100606 to Zhao et al. (“Zhao”) [NOTE: the relied-upon portions of Zhao are fully supported by the 10/02/2019 Priority Application (U.S. 62/909,361)].
8. Regarding claim 1, Zhao discloses an electrosurgical system, comprising:
a vessel sealer [end effector assembly (10) of forceps (100) - ¶[0046]; FIG. 1A] having a pair of jaws [jaw members (11, 12) - ¶[0049] (“End effector assembly 10 is shown attached at distal end 114 of shaft 112 and includes a pair of opposing jaw members 11 and 12. Each of jaw members 11 and 12 includes an electrically-conductive tissue treating surface 13, 14, respectively, configured to grasp tissue therebetween and conduct electrosurgical energy therethrough to treat, e.g., seal, tissue”)]; and
an electrosurgical generator [electrosurgical generator (160) - ¶’s [0046], [0055]; FIGS. 1A, 2] coupled to the pair of jaws [(11, 12)] of the vessel sealer [(10)] [see ¶[0047] (“Forceps 100 may further include a surgical cable extending therefrom and configured to connect forceps 100 to an electrosurgical generator 160 such that at least one of the electrically-conductive tissue treating surfaces 13, 14 of jaw members 11, 12 of end effector assembly 10 may be energized to treat tissue grasped therebetween”)] and configured to output radiofrequency energy to the vessel sealer [¶’s [0047], [0055], [0056]] according to a predetermined continuous power curve [e.g., ¶[0069] (“a particular energy-delivery algorithm based upon which the power supply 164 and RF output stage 162 provide energy to end effector assembly 10”); ¶[0091]; FIG. 11];
wherein the predetermined continuous power curve starts with a first power delivery segment [the first segment of the upper Power (W) v. Time (s) plot of FIG. 11 commencing at approx. 50W at 0 sec] that commences at a first power level [approx. 50W - FIG. 11] and continuously decreases to a second, non-zero power level [decreases to approx. 37.5W at 0.5 sec] and then continues with a second power delivery segment [the second segment of the upper Power (W) v. Time (s) plot of FIG. 11 commencing at approx. 37.5W at 0.5 sec] that commences with the second, non-zero power level [approx. 37.5W] and increases to a final power level [increases to approx. 175W at 0.6 sec].
9. Regarding claim 2, Zhao discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Zhao further discloses wherein the first power delivery segment occurs during a time period of between 0.250 and 9.75 seconds [FIG. 11; from 0 sec to 0.5 sec, or a total of approx. 0.5 secs].
10. Regarding claim 4, Zhao discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Zhao further discloses wherein the electrosurgical generator is configured to deliver an amount of power during the first power delivery segment that will not cause any tissue trapped in the pair of jaws to reach a temperature that results in boiling of any moisture in the tissue [NOTE: Applicant’s Specification indicates that this condition is satisfied (i.e., temperature of the tissue is not raised to its boiling point) if power delivery commences at a power level of at least 40 Watts and is continuously decreased to a predetermined non-zero minimum power Mp over a time period of between 0.250 and 9.75 seconds - see as-filed Specification at ¶[0018] (“First power delivery segment 52 commences at a power level of at least 40 Watts and then the power level is continuously decreased to a predetermined non-zero minimum power Mp over a time period of between 0.250 and 9.75 seconds, and optimally about 0.750 seconds. First power delivery segment 52 is configured to generate a quantity of energy sufficient to raise the temperature of the inherent thermal mass of the electrodes and jaw components without raising the temperature of the tissue to its boiling point”); Zhao discloses a first delivery segment commencing at about 50W and decreasing to about 37.5W over a period of 0.5 seconds (FIG. 11); as such, it is the Examiner’s position that commencing power at a similar value (about 50W) as Applicant (at least 40W), and continuously decreasing it over a time period at the low end of Applicant’s range (0.5 secs) would therefore likewise not cause any tissue trapped in the pair of jaws to reach a temperature that results in boiling of any moisture in the tissue].
11. Regarding claim 5, Zhao discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Zhao further discloses wherein the electrosurgical generator is configured to deliver an amount of power during the first power delivery segment that causes any tissue trapped in the pair of jaws to desiccate [e.g., ¶’s [0043], [0091]; FIG. 10; note that the claim does not specify the level/extent of dessication; as such, broadly, any dessication satisfies the claim limitation].
12. Regarding claim 6, Zhao discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Zhao further discloses wherein the electrosurgical generator is configured to ensure that the final power level will not cause over-desiccation of any tissue trapped in the pair of jaws [see ¶[0074] (“During such sealing process, the sensor circuitry, e.g., sensor module 166, of the generator 160 may sense parameters of the vessel and/or energy such as, for example, impedance and power, and/or may supply data from which impedance and/or power can be derived such as for example, time, voltage, and/or current data… This may occur as a snapshot or over a time interval and may be determined at the beginning of vessel sealing, e.g., at or within 250 ms of initiation of vessel sealing, to avoid permanent damage to tissue should it be determined that application of energy should be discontinued”)].
13. Regarding claim 8, Zhao discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Zhao further discloses wherein the first power delivery segment has a shape selected from the group consisting of linear, concave, convex [FIG. 11], and combinations thereof.
14. Regarding claim 9, Zhao discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Zhao further discloses wherein the second power delivery segment has a shape selected from the group consisting of linear [FIG. 11], concave, convex, and combinations thereof.
15. Regarding claim 11, Zhao discloses a method of controlling the power output from an electrosurgical generator [electrosurgical generator (160) - ¶’s [0046], [0055]; FIGS. 1A, 2] to a vessel sealer [end effector assembly (10) of forceps (100) - ¶[0046]; FIG. 1A] having a pair of jaws [jaw members (11, 12) - ¶[0049] (“End effector assembly 10 is shown attached at distal end 114 of shaft 112 and includes a pair of opposing jaw members 11 and 12. Each of jaw members 11 and 12 includes an electrically-conductive tissue treating surface 13, 14, respectively, configured to grasp tissue therebetween and conduct electrosurgical energy therethrough to treat, e.g., seal, tissue”)], comprising:
providing the vessel sealer [(10)] having the pair of jaws [jaw members (11, 12)];
coupling the electrosurgical generator [electrosurgical generator (160)] to the pair of jaws [(11, 12)] of the vessel sealer [see ¶[0047] (“Forceps 100 may further include a surgical cable extending therefrom and configured to connect forceps 100 to an electrosurgical generator 160 such that at least one of the electrically-conductive tissue treating surfaces 13, 14 of jaw members 11, 12 of end effector assembly 10 may be energized to treat tissue grasped therebetween”)];
powering the electrosurgical generator [(160)] to output radiofrequency energy to the vessel sealer [(10)] according to a predetermined continuous power curve [e.g., ¶[0069] (“a particular energy-delivery algorithm based upon which the power supply 164 and RF output stage 162 provide energy to end effector assembly 10”); ¶[0091]; FIG. 11], wherein the predetermined continuous power curve starts with a first power delivery segment [the first segment of the upper Power (W) v. Time (s) plot of FIG. 11 commencing at approx. 50W at 0 sec] that commences at a first power level [approx. 50W - FIG. 11] and then continuously decreases to a second power level [decreases to approx. 37.5W at 0.5 sec] and a second power delivery segment [the second segment of the upper Power (W) v. Time (s) plot of FIG. 11 commencing at approx. 37.5W at 0.5 sec] that commences with the second power level [approx. 37.5W] and increases to a final power level [increases to approx. 175W at 0.6 sec].
16. Regarding claim 12, Zhao discloses all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
Zhao further discloses wherein the first power delivery segment occurs during a time period of between 0.250 and 9.75 seconds [FIG. 11; from 0 sec to 0.5 sec, or a total of approx. 0.5 secs].
17. Regarding claim 14, Zhao discloses all of the limitations of claim 11 for the reasons set forth in detail (above) in the Office Action.
Zhao further discloses wherein the electrosurgical generator is configured to deliver an amount of power during the first power delivery segment that will not cause any tissue trapped in the pair of jaws to reach a temperature that results in boiling of any moisture in the tissue [NOTE: Applicant’s Specification indicates that this condition is satisfied (i.e., temperature of the tissue is not raised to its boiling point) if power delivery commences at a power level of at least 40 Watts and is continuously decreased to a predetermined non-zero minimum power Mp over a time period of between 0.250 and 9.75 seconds - see as-filed Specification at ¶[0018] (“First power delivery segment 52 commences at a power level of at least 40 Watts and then the power level is continuously decreased to a predetermined non-zero minimum power Mp over a time period of between 0.250 and 9.75 seconds, and optimally about 0.750 seconds. First power delivery segment 52 is configured to generate a quantity of energy sufficient to raise the temperature of the inherent thermal mass of the electrodes and jaw components without raising the temperature of the tissue to its boiling point”); Zhao discloses a first delivery segment commencing at about 50W and decreasing to about 37.5W over a period of 0.5 seconds (FIG. 11); as such, it is the Examiner’s position that commencing power at a similar value (about 50W) as Applicant (at least 40W), and continuously decreasing it over a time period at the low end of Applicant’s range (0.5 secs) would therefore likewise not cause any tissue trapped in the pair of jaws to reach a temperature that results in boiling of any moisture in the tissue].
Claim Rejections - 35 USC § 103
18. 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.
19. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
20. Claims 3 & 13 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao.
21. Regarding claims 3 & 13, Zhao discloses all of the limitations of claims 1 &11, respectively, for the reasons set forth in detail (above) in the Office Action.
Zhao discloses that the second power delivery segment [the second segment of the upper Power (W) v. Time (s) plot of FIG. 11 commencing at approx. 37.5W at 0.5 sec, and increasing to approx. 175W at 0.6 sec] occurs during a total time period of approximately 0.1 sec. As such, Zhao does not explicitly disclose:
[claims 3 & 13] wherein the second power delivery segment occurs during a time period of between 0.250 and 9.75 seconds.
However, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Zhao such that the second power delivery segment occurs during a time period of between 0.250 and 9.75 seconds, since it has been held that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
22. Claims 7 & 15 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao in view of U.S. Patent Application Publication No. 2011/0319882 to Kennedy et al. (“Kennedy”).
23. Regarding claims 7 & 15, Zhao discloses all of the limitations of claims 1 & 11, respectively, for the reasons set forth in detail (above) in the Office Action.
While Zhao discloses measuring and using impedance in a determination of whether the application of energy should be discontinued to avoid permanent damage to tissue [see ¶[0074]], Zhao does not explicitly disclose:
[claims 7 & 15] wherein the electrosurgical generator is configured to ensure that the second power delivery segment ends when any tissue in the pair of jaws has an impedance that exceeds a predetermined value.
Kennedy, in a similar field of endeavor, teaches electrosurgical procedures, techniques, and devices that utilize radiofrequency energy to seal blood vessels during surgical procedures [e.g., ¶[0002]].
Kennedy teaches that it was known for an electrosurgical generator to be configured to ensure that a power delivery segment ends when any tissue in the pair of jaws has an impedance that exceeds a predetermined value [e.g., ¶[0013] (“…and terminate the flow of power to the vessel being sealed when the impedance of the vessel being sealed reaches a predetermined level”)].
Given that Zhao is already concerned with using impedance in a determination of whether the application of energy should be discontinued to avoid permanent damage to tissue (as noted above), it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Zhao such that the electrosurgical generator is configured to ensure that the second power delivery segment ends when any tissue in the pair of jaws has an impedance that exceeds a predetermined value, since such a particular known technique [use of an impedance threshold in determining when power delivery should be discontinued to avoid tissue damage] was recognized as part of the ordinary capabilities of one skilled in the art, as clearly demonstrated by Kennedy, and one of ordinary skill in the art would have been capable of applying this known technique to the known device/method of Zhao, and the results [discontinuing power delivery when an impedance threshold is met to avoid tissue damage] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
24. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Zhao in view of U.S. Patent Application Publication No. 2015/0119870 to Rudie ("Rudie").
25. Regarding claim 10, Zhao discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Zhao further discloses that the second power delivery segment is linear [FIG. 11].
Zhao does not, however, disclose that:
the first power delivery segment comprises an exponential decay curve.
Rudie, in a similar field of endeavor, teaches that it was known to apply power as an exponential decay function as it allows for quicker initial heating, thereby reducing power application time, and keeps thermal injury tightly controlled [¶[0163]; FIG. 27].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Zhao such that the first power delivery segment comprises an exponential decay curve so as to provide the benefit/advantage of allowing for quicker initial heating, thereby reducing power application time, and keeping thermal injury tightly controlled, as explicitly taught by Rudie.
Response to Arguments
26. As noted above, the 12/02/25 Amendment has overcome the rejections under §§ 102 & 103 previously set forth in the 09/04/25 Action.
27. Applicant's arguments concerning the prior rejections under §§ 102 & 103 have been fully considered and are persuasive (in view of the current Amendment). Therefore, these rejections have been withdrawn. However, upon further consideration, new grounds of rejection under §§ 102 & 103 are set forth in detail above, necessitated by Applicant’s Amendment.
Conclusion
28. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
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 an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Bradford C. Blaise/Examiner, Art Unit 3794