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.
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 1-4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Witte (US 2020/0237423) in view of Yang (US 2016/0184002).
Regarding claims 1, 3, 4 and 9, Witte discloses an end effector comprising movable jaws (582, 584, fig. 36), an electromagnetic induction coil ([0182], see discussion associated with fig. 23), a thermal cutting element disposed adjacent to the coil and protruding from the jaw and made of ferromagnetic material to be heated by the coil (570, [0182]) and a cooling system disposed in the jaw adjacent to the cutting element to absorb heat from the thermal element (578, [0183]). This embodiment of Witte does not disclose that the cooling system operates by circulating fluid through a jaw. However, another embodiment of Witte discloses the use of a tubes with two conduits for circulating a fluid (i.e. a liquid or a gas) that extend parallel to the jaw member (1581, fig. 53-56). It has been held that the simple substitute of one known element for another is an obvious modification (MPEP 2141(III)), where in this case the cooling elements are clearly recognized as being useful for the same, if not identical, function. Therefore, before the application was filed, it would have been obvious to modify the first embodiment of Witte to include the circulating cooling tube of the second embodiment of Witte that would produce the predictable result of cooling tissue. Further, it has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)). Therefore, additionally, it would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the second embodiment of Witte to include the thermal cutting structure of the first embodiment that would produce the predictable result of allowing the second embodiment to have the tissue treatment functions disclosed with respect to the first embodiment. In both these modifications, the tube and blade have the claimed relationship regarding their respective lengths (as can be seen where the relevant figures show both features). Since both these modifications involve only the teachings of Witte, both should be understood as being modified wherever a reference to “Witte” occurs below. Witte does not specifically disclose that the thermal cutting element is disposed “at least partially within” the coil. This is an extremely broad limitation by itself, as even a fraction of a millimeter of the cutting element overlapping with the internal area of the coil would read on the claim. This is a broad limitation even excluding the interpretation that, when view from the top so that the cutting element and the coil are in the same plane, the cutting element is “within” the coil. It is fairly common in the ablation technology to heat an element that is at least partially within a coil, such as taught by Yang (fig. 5). It has been held that the combination of known elements according to known methods to yield predictable results is an obvious modification (MPEP 2141(III)), where in this case the known elements are the configuration of a ferromagnetic material with respect to an induction coil. Therefore, before the application was filed, it would have been obvious to modify the device of Witte to including the thermal element to be at least partially within an induction coil, such as taught by Yang, that would produce the predictable result of heating the thermal cutting element in a desired manner.
Regarding claim 2, the two embodiments of Witte cited above do not specifically disclose the use of electrodes as tissue contacting surfaces. However, another embodiment of Witte does disclose this feature (970, fig. 41). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the device of Witte to include electrodes on the jaws as tissue contacting surfaces that would produce the predictable result of allowing a user to treat tissue in a desired manner.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Witte and Yang, further in view of Couture (US 2006/0217709).
Regarding claim 8, Witte does not disclose of compressed air specifically although there is a suggestion that a gas or liquid may be employed as the cooling medium ([0183]). Couture discloses a forceps device and teaches that a tube with two conduits that extend the length of the jaw (fig. 11) can be supplied with air to cool the hot elements of jaws ([0123]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the device of Witte to use any commonly fluid for cooling the jaw, including air pressured to circulate through conduits as taught by Couture, that would produce the predictable result of allowing a user to control temperature of the jaw.
Claims 7, 10, 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Witte and Yang, further in view of Wittenberger (US 2004/0254606).
Regarding claim 7, 10, 11 and 14, the device of Witte as modified does not disclose the use of an expansion nozzle. However, expansion nozzles are commonly used for cooling substances. Wittenberger, for example, disclose a forceps that uses two conduits for cooling where the transition between conduits is provided by a nozzle for expansion of a gas for cooling (fig. 2, note discussion in [0070]). More specifically, Wittenger explicitly states what would be well known to those of ordinary skill in the art, that cooling can be performed by a cooled from introduced into a medical device, by allowing a liquid to boil or vaporize or (note the alternative), by allowing a gas to expand ([0070]). Note that Wittenberger also discloses an open-loop embodiment (fig. 4) as in one of the embodiments of Witte, thus suggestion that open loop cooling and closed loop cooling are functional equivalents (MPEP 2144.06), a rationale that is noted but not relied upon for a rejection. Therefore, before the application was filed, it would have been obvious to modify the device of Witte to include an expansion nozzle at the transition between tubes, such as taught by Wittenberger, that would produce the predictable result of cooling the fluid that passes through the tubes, thus cooling the tissue region as desired.
Double Patenting
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).
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).
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.
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.
Claim 1-4, 7-11 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/025,106 in view of one or more of Witte, Yang, Couture and Wittenberger. The claims of the copending application (in which a Notice of Allowance has been issued) have all the pending claim limitations directed to the jaws, inductive coil and thermal cutting element, but lack the pending claim limitations directed to the cooling structures. However, those cooling structures are disclosed in one or more of Witte, Yang, Couture and Wittenberger. Therefore, it would have been obvious to modify the claims of the copending application to include the cooling structures disclosed by one or more of Witte, Yang, Couture and Wittenberger, for the reasons discussed above.
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
Claims 5, 6, 12 and 13 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.
Response to Arguments
Applicant's arguments, to the extent they are relevant to the claims as amended, are not persuasive. Regarding the means of heating the heating element, the examiner concedes that Witte could have been written in a clearer manner. However, it is maintained that Witte contemplates using coils for heating the heating element as one available mechanism of heating. Prior to discussing the embodiment of figure 36, Witte discusses both the use of a coil to heat a distinct element having a ferromagnetic coating (fig. 23, [0162]) and the use of a conductive line having a ferromagnetic coating (fig. 26). When discussing the embodiment of figure 36 Witte specifically states that like the “conductive lines and coils described above” the heating element can be coated to generate heat. But, first, the conductive coating is present in both the previously discussed embodiments and, second, the conductive lines coated with the ferromagnetic material are never referred to as coils, always lines. Thus, the fairer reading of Witte is that the heating element of figure 36 can be heated either by virtue of being supplied directly with current as discussed with respect to the conductive lines or can be heated by virtue of being indirectly heated with a magnetic field as discussed with respect to the conductive coils. This is supported by the fact that the embodiment of figure 36 is not primarily directed to the heating element but rather the cooling system. Thus, it is reasonable to interpret Witte to be saying, in effect, that either of the previously described structures could be used to heat the heating element of this embodiment rather than providing redundant descriptions. Applicant makes some other comments about using the heating element without the need for a separate coil for heating and coagulating, but in the embodiment with coils it is not the coils but the ferromagnetic element that is heated. Only in the embodiment with the conductive lines are the lines heated, and that embodiment has no coils. In every embodiment the heating element can coagulate and cut, even where the heated element is a plate ([0162]), although note that Witte expressly suggests the plate in figure 23 could be provided with a physical cutting blade ([0162]). Finally, it is noted that the fact that Witte refers to lines, coils or heating elements is evidence of nothing other than that there are at least three embodiments of the invention.
Regarding the use of a gas, Applicant reads restrictions into Witte that are not there. Witte specifically uses the word “fluid” which includes both liquid and gas and then notes that “e.g.,” meaning “for example,” a specific fluid can be used. Thus, Witte is not limited to water or saline which are merely examples of the type of fluids that could be employed. Using fluids as a cooling medium, which are explicitly stated to be liquids or gases, is well known in the art. For example, see paragraph [0118] of US 2006/0217709 to Couture which states that either water (a liquid) or air (a gas) can be used as a cooling fluid.
Regarding the expansion of gas in Wittenberger, the argument is unpersuasive because it misrepresents Wittenberger and it ignores how a person of ordinary skill in the art would understand the reference. Circulating cooling fluid, allowing liquid to evaporate, or using expanding gas are all well-known methods of cooling. Wittenberger explicitly lists those options in the alternative where using a nozzle to allow expansion of gas is clearly different from cooling the fluid before introduction into the device. That is, contrary to Applicant’s statement that Wittenberger describes that fluid can be cooled prior to its introduction into the medical device “by” allowing a gas state to expand, Wittenberger actually teaches that fluid can be cooled prior to its introduction into the medical device “or” by allowing a gas state to expand. Further, these options are expressly for achieving an extremely low temperature “at” the ablation segment. Figure 2 of Wittenberger shows the nozzle at the distal end of the fluid pathway where the gas will expand due to the difference in diameters of the inlet versus the outlet. To further support this position, it is noted that Zachman (US 2011/0245821) is related to Wittenberger and uses an almost identical paragraph ([0025]) to paragraph [0070] of Wittenberger and further discloses that the nozzles at the distal end of the inlet flow path, within the device adjacent to the tissue to be cooled, are expansion nozzles ([0029], see also [0007]). That Wittenberger does not feel the need to expressly define an expansion nozzle in a specific embodiment, beyond showing one and stating that it is possible to use one, is in the same category as a passing mention that a temperature sensor could be used or that a device could include a handle. Such elements are ubiquitous and well understood. Wittenberger was employed exactly because of the reference to the level of ordinary skill in the art regarding the various species of cooling elements and how unimportant they are to at least most cooling systems. But that type of teaching is not necessary for a rejection since there are thousands of medical devices that use Joule-Thomson nozzles to cool by expansion. To further support the position being taken on the level of ordinary skill in the art, Saidi (US 3,658,066, filed in 1970) discloses a medical device with cooling and teaches that the cooling can be accomplished by circulating an externally cooled fluid or by using an expansion nozzle (col. 1 line 70 to col. 2 line 4), where the expansion nozzle is located within the device proximate to the region being cooled (38, fig. 1). Applicant also makes an argument about the fact that Witte discloses controlling temperature. It is unclear what Applicant understands the relationship to be between controlling temperature and the use of an “in-jaw” cooling mechanism. Even systems with expansion nozzles can control temperature by adjusting the inflow or outflow pressure of the fluid (e.g. paragraph [0260] of US 2013/0310823 to Gelfand).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
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/DANIEL W FOWLER/Primary Examiner, Art Unit 3794