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 .
2. 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.
Claim Rejections - 35 USC § 103
3. 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.
The factual inquiries 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.
4. Claims 1-7, 10-14, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Honda U.S. 2016/0310207 (herein referred to as “Honda”) and in view of Boudreaux U.S. 2019/0274708 (herein referred to as “Boudreaux”).
5. Regarding Claim 1, Honda teaches an electrosurgical system (Fig. 1), comprising:
a first jaw member (Fig. 1, ref num 13a) and a second jaw member (Fig. 1, ref num 13b) each defining a tissue treating surface (Fig. 4, ref num 23a and 23b), the first jaw member and the second jaw member pivotably coupled to one another such that at least one of the first jaw member or the second jaw member is movable relative to the other from a spaced-apart position to an approximated position (para 0030, “the holding section 13 includes two jaw members 13a and 13b capable of opening and closing”) to grasp tissue between the tissue treating surfaces (para 0030, “the holding section 13 is a treatment section that holds a biological tissue serving as a treatment target and performs treatment”), one of the first jaw member or the second jaw member including a cutting element facing the other of the first jaw member or the second jaw member (Fig. 4, ref num 27 faces ref num 23a); and
b. a generator (Fig. 1, ref num 3) coupled to the cutting element (Fig. 1, ref num 3 is connected to the cutting element via ref num 15).
Honda fails to teach the generator is configured to: (b.1) provide power to the cutting element while tissue contact with the cutting element is not detected, (b.2) detect tissue contact with the cutting element, and (b.3) ramp up the power to the cutting element in response to the detection of the tissue contact with the cutting element.
Boudreaux teaches an electrosurgical system of analogous art (Figs. 1-3), such that the system comprises a first and second jaw members (Fig. 3, ref num 1140, 1142a/b) and a generator (Fig. 3, ref num 1100). The generator is configured to provide power to a cutting element while tissue contact with the cutting element is not detected (para 0357, “power delivery can be reduced when there is a high probability that the ultrasonic blade is contacting the clamp arm pad (e.g., without tissue in between)…”), detect tissue contact with the cutting element (Fig. 31, ref nums 132172, 132174), and ramp up the power to the cutting element in response to the detection of the tissue contact with the cutting element (Fig. 31, ref num 132176; para 0413). This optimizes the power level to be applied to the tissue based on the profile of the tissue (para 0414). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Honda to provide power based on the response to the detection of the tissue contact with the cutting element in order to optimize the power level applied to the tissue.
6. Regarding Claim 2, Honda teaches the generator is configured to detect the tissue contact by sensing a change in resistance of the cutting element (para 0090).
7. Regarding Claim 3, Honda fails to teach the generator is configured to provide the power to the cutting element while the tissue contact with the cutting element is not detected, detect the tissue contact with the cutting element and ramp up the power to the cutting element while activation of a switch is maintained.
Boudreaux teaches an electrosurgical system of analogous art (Figs. 1-3), such that the system comprises a first and second jaw members (Fig. 3, ref num 1140, 1142a/b) and a generator (Fig. 3, ref num 1100). The generator is configured to provide power to a cutting element while tissue contact with the cutting element is not detected (para 0357, “power delivery can be reduced when there is a high probability that the ultrasonic blade is contacting the clamp arm pad (e.g., without tissue in between)…”), detect the tissue contact with the cutting element (Fig. 31, ref nums 132172, 132174), and ramp up the power to the cutting element in response to the detection of the tissue contact with the cutting element (Fig. 31, ref num 132176; para 0413) while activation of a switch is maintained (para 0248-0249). This optimizes the power level to be applied to the tissue based on the profile of the tissue (para 0414). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Honda to provide power based on the response to the detection of the tissue contact with the cutting element in order to optimize the power level applied to the tissue.
8. Regarding Claim 4, Honda fails to teach the generator is configured to provide the power to the cutting element while the tissue contact with the cutting element is not detected, detect the tissue contact with the cutting element, and ramp up the power to the cutting element while the first jaw member and the second jaw member are disposed in the spaced-apart position.
Boudreaux teaches an electrosurgical system of analogous art (Figs. 1-3), such that the system comprises a first and second jaw members (Fig. 3, ref num 1140, 1142a/b) and a generator (Fig. 3, ref num 1100). The generator is configured to provide power to a cutting element while tissue contact with the cutting element is not detected (para 0357, “power delivery can be reduced when there is a high probability that the ultrasonic blade is contacting the clamp arm pad (e.g., without tissue in between)…”), detect the tissue contact with the cutting element (Fig. 31, ref nums 132172, 132174), and ramp up the power to the cutting element in response to the detection of the tissue contact with the cutting element (Fig. 31, ref num 132176; para 0413) while the first and second jaw members are disposed in a spaced-apart position (Fig. 25 and 29; para 0063, 0366, 0378). is optimizes the power level to be applied to the tissue based on the profile of the tissue (para 0414). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Honda to provide power based on the response to the detection of the tissue contact with the cutting element in order to optimize the power level applied to the tissue.
9. Regarding Claim 5, Honda teaches the generator is electrically coupled to the first jaw member and the second jaw member and configured to provide electrical energy to the tissue treating surfaces to seal tissue disposed between the first jaw member and the second jaw member (para 0040, “Sealing treatment for the biological tissue by high-frequency energy is performed by allowing a predetermined high-frequency current to flow between the electrode 23a and the electrode 23b in a state in which the biological tissue is held between the electrode 23a and the electrode 23b”).
10. Regarding Claim 6, Honda fails to teach the generator is configured to, after ramping up the power: regulate the power to the cutting element at a power level associated with dissection.
Boudreaux teaches the generator is configured to, after ramping up the power (Fig. 31, ref num 132176) regulate the power to the cutting element at a power level associated with dissection (para 0414, “if the tissue is initially tough and then weakens or if different layers of tissue are encountered during the transection process, the power level can be optimally adjusted to match the profile of the ultrasonic blade. This method could eliminate the need for the user to set the power level. The ultrasonic device would adapt and choose the right power level based on current tissue conditions and transection process”). By adjusting the power level, this optimizes the device in order to produces the same expected result of transecting the target tissue (para 0414). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Honda to regulate the power at a power level associated with dissection in order to produce the same expected result of transecting the target tissue.
11. Regarding Claim 7, Honda teaches the power level associated with the dissection maintains a dissection temperature of the cutting element from about 350°C to about 550°C (para 0055, “In order to dissect the biological tissue at temperature between 200° C. and 400° C”).
12. Regarding Claim 10, Honda teaches an electrosurgical system (Fig. 1), comprising:
a first jaw member (Fig. 1, ref num 13a) and a second jaw member (Fig. 1, ref num 13b) each defining a tissue treating surface (Fig. 4, ref num 23a and 23b), the first jaw member and the second jaw member pivotably coupled to one another such that at least one of the first jaw member or the second jaw member is movable relative to the other from a spaced-apart position to an approximated position (para 0030, “the holding section 13 includes two jaw members 13a and 13b capable of opening and closing”) to grasp tissue between the tissue treating surfaces (para 0030, “the holding section 13 is a treatment section that holds a biological tissue serving as a treatment target and performs treatment”), one of the first jaw member or the second jaw member including a cutting element (Fig. 4, ref num 27 faces ref num 23a); and
a generator Fig. 1, ref num 3) coupled to the cutting element (Fig. 1, ref num 3 is connected to the cutting element via ref num 15) and configured to:
detect activation of a switch (Fig. 1, ref num 4, para 0032, 0089); provide power to the cutting element at a first power level associated with dissecting the tissue (para 0041, 0043; para 0075, “input section 34 is an input device for setting temperature values, voltage values of high-frequency energy outputs… setting the… first dissection temperature”).
Honda also teaches a plurality of dissection temperatures, sealing temperatures, high-frequency energy levels, in which they are set at a certain level depending on the mode that is activated (para 0066-0067, 0075).
Honda fails to teach while activation of the switch is maintained: detect tissue contact with the cutting element; in response to detecting the tissue contact; detect a loss of tissue contact with the cutting element; and reduce the power to the cutting element.
Boudreaux teaches an electrosurgical system of analogous art (Figs. 1-3), such that the system comprises a first and second jaw members (Fig. 3, ref num 1140, 1142a/b) and a generator (Fig. 3, ref num 1100). The generator is configured to detect tissue contact with the cutting element (Fig. 31, ref nums 132172, 132174), and ramp up the power to the cutting element in response to the detection of the tissue contact with the cutting element (Fig. 31, ref num 132176; para 0413), then detect a loss of tissue contact with the cutting element and reduce the power to the cutting element (para 0357, “power delivery can be reduced when there is a high probability that the ultrasonic blade is contacting the clamp arm pad (e.g., without tissue in between)…”). This optimizes the power level to be applied to the tissue based on the profile of the tissue (para 0414). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Honda to provide power based on the response to the detection of the tissue contact with the cutting element in order to optimize the power level applied to the tissue.
13. Regarding Claim 11, Honda teaches the generator is configured to detect the tissue contact by sensing a change in resistance of the cutting element (para 0090).
14. Regarding Claim 12, Honda teaches the generator is configured to detect the loss of tissue contact by sensing a change in resistance of the cutting element (para 0090, implied that the resistance value would detect loss of tissue contact).
15. Regarding Claim 13, Honda teaches the generator is further configured to terminate power to the cutting element upon deactivation of the switch (para 0032, “A surgeon operates a pedal of the footswitch 4, whereby ON and OFF of supply of energy from the main body apparatus 3 to the treatment instrument 2 are switched”).
16. Regarding Claim 14, Honda teaches the generator is electrically coupled to the first jaw member and the second jaw member and configured to provide electrical energy upon activation of a second switch (para 0073-0074) to the tissue treating surfaces to seal tissue disposed between the first jaw member and the second jaw member (para 0040, “Sealing treatment for the biological tissue by high-frequency energy is performed by allowing a predetermined high-frequency current to flow between the electrode 23a and the electrode 23b in a state in which the biological tissue is held between the electrode 23a and the electrode 23b”).
17. Regarding Claim 18, Honda teaches providing the power to the cutting element at the first power level causes the cutting element to reach a dissection temperature (para 0055).
18. Regarding Claim 19, Honda teaches the power level associated with the dissection maintains a dissection temperature of the cutting element from about 350°C to about 550°C (para 0055, “In order to dissect the biological tissue at temperature between 200° C. and 400° C”).
19. Claims 8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Honda and Boudreaux, and further in view of Manwaring U.S. 2013/0066310 (herein referred to as “Manwaring”).
20. Regarding Claim 8, Honda fails to teach the power level associated with the dissection maintains a dissection temperature of about 550°C.
Manwaring teaches an electrosurgical system of analogous art (Fig. 1), wherein the system comprises an instrument with a first and second jaw (Fig. 1, ref nums 20a and 20b), such that there is a thermal cutting element from the jaws (ref num 110 or 130B, para 0072). The cutting element is heated to a temperature of about 500°C (para 0072) so that cutting may be achieved (para 0072). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have cutting element be increased to a temperature of about 550°C for the purpose of dissecting the tissue, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
21. Regarding Claim 20, Honda fails to teach the power level associated with the dissection maintains a dissection temperature of about 550°C.
Manwaring teaches an electrosurgical system of analogous art (Fig. 1), wherein the system comprises an instrument with a first and second jaw (Fig. 1, ref nums 20a and 20b), such that there is a thermal cutting element from the jaws (ref num 110 or 130B, para 0072). The cutting element is heated to a temperature of about 500°C (para 0072) so that cutting may be achieved (para 0072). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have cutting element be increased to a temperature of about 550°C for the purpose of dissecting the tissue, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
22. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Honda and Boudreaux, and further in view of Takashino U.S. 2017/0252087 (herein referred to as “Takashino”).
23. Regarding Claim 9, Honda fails to teach providing power to the cutting element while tissue contact with the cutting element is not detected maintains a pre- dissection temperature of the cutting element in a range of about 20°C to about 60°C.
Takashino teaches a system of analogous art (Fig. 1), wherein the initial temperature of a treatment surface (ref num 21, ref character “Ta”) may be about 60°C (para 0074). Therefore, it is understood that when providing power, the temperature of the treatment surface would be at the pre-dissection temperature. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the pre-dissection temperature maintained in a range of about 20°C to about 60°C, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Double Patenting
24. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
25. A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
26. The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
27. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
28. Claims 10-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,251,155. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patent anticipate the claims of the instant application. Here, the more specific patent claims encompass the broader instant application claims. For example, Claim 10 of the instant application discusses a generic system comprising a first jaw member, a second jaw member, and a generator, wherein the generator is configured to detect activation of a switch, and detect tissue contact with a cutting element in order to adjust the power level associated with the tissue contact, which is a broader recitation compared to the limitations outlined in the reference patent. Following the rationale in In re Goodman cited in the preceding paragraph, wherein the applicant has once been granted a patent containing a claim for the specific narrow invention, the applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Allowable Subject Matter
29. Claims 15-17 contain allowable subject matter. Based on the findings from the parent application, and review of the prior art, the prior art of record fails to specifically teach before detecting the tissue contact and while the activation of the switch is maintained, provide power to the cutting element at a second power level lower than the first power level while tissue contact with the cutting element is not detected. The prior art also fails to provide sufficient motivation to make such specific modifications and would require improper use of hindsight to arrive at the claimed invention when considered along or in any proper combination.
30. Claims 15-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
31. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
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