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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the elongated slots having a constant radius of curvature from a proximal portion to a distal portion of the jaw, the respective elongated slots having first and second radii of curvature at proximal and distal portions, and the elongated slots having a radius of curvature defined by an elliptical function (claims 6-8 and 14-16) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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, 5, 9-11, 17, 18, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Kennedy (US 2011/0319882) in view of Johnson (US 2007/0078459) and Shields (US 2005/0021027).
Regarding claims 1-3, 9-11, 17, 18, 21 and 22, Kennedy discloses an electrosurgical instrument with a pair of opposing jaws that include sealing surfaces (130, 132, [0047], [0050]) connected by electrical conductors that extend from the distal side of the instrument to the proximal side of the instrument (151a-b, fig. 6C) through a rod (212 or 102). Kennedy discloses the jaws are between 1-3.5 mm wide ([0033]) and that the sealing surfaces are configured to provide a current concentration of at least 0.03 Amperes per square millimeter when operated at a power of 50 Watts or less ([0072]-[0073] Kennedy does not disclose a cutting mechanism that translates through an elongate channel formed by two slots in the first and second jaws. However, such a cutting mechanism is common in the art. Johnson, for example, discloses an electrosurgical instrument with a pair of opposing jaws that include sealing surfaces (112, 122, fig. 2) and further teaches that the middle of the sealing surfaces are provided with respective slots ([0074]) that forming an elongate channel for a cutting mechanism ([0074]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the instrument of Kennedy to include a cutting element movable through central elongated slots forming an elongate channel as taught by Johnson that would produce the predictable result of allowing a user to cut tissue with the instrument. Neither Kennedy (not having slots) nor Johnson (not disclosing the width of the sealing surface) disclose the distance from the longitudinal edges of the slots to the elongate outer edges of the sealing surface. However, as noted above, Kennedy discloses a width of 1-3.5mm for the sealing surface and Johnson teaches the slots are formed in the middle of the sealing surface. Therefore, the range of distances between the edge of the slot and the outer edge of the sealing surface in Kennedy after modification is half the range disclosed by Kennedy, 0.5-1.75mm (actually slightly less than that, considering the width of the slot itself). Therefore, before the application was filed, it would have been obvious to further modify the system of Kennedy to include jaws having any commonly known width, including 1 mm as taught by Kennedy, such that the modified instrument has a distance from the edge of the central slot to the outer edge of the sealing surface of 0.5mm (or less, accounting for the width of the slot itself), that would produce the predictable result of an instrument that can be used to interact with tissue in a desired manner. Kennedy does not disclose the gap between the jaws varies along a longitudinal length. However, Kennedy only teaches a constant gap in the context of pressure applied to tissue over a period of time (“so that as the tissue contracts during heating,” [0073]), and it is not even clear whether this gap is constant along the longitudinal length or just constant at a specific point in the jaw over the time period during which pressure is applied to tissue. In fact, the prior art is very well acquainted with variable gap distance and there is no evidence that using variable gap distance produces an unexpected result here (within the meaning of MPEP 716.02(a)). In fact, Applicant has specifically noted that the gap can be constant ([0064]) or variable ([00110]) along the longitudinal length which suggests the opposite, that both do what a person of ordinary skill in the art would expect. The prior art agrees with Applicant that the gap distance along the longitudinal length is a matter for a person of ordinary skill in the art to determine. Shields, for example, discloses an electrosurgical forceps with a plurality of independently controllable stops to vary the gap along the length of the jaw “depending upon a particular purpose or to achieve a particular tissue seal” ([0045]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the instrument of Kennedy to include adjustable stops to allow a variable gap distance along the length of the jaw as taught by Shields to produce the predictable result of allowing a user to achieve a particular uprose including a particular tissue seal.
Regarding claim 5, Kennedy, as discussed above, has the structural elements “configured to” provide a current concentration of 0.03 amps per millimeter squared. Beyond that, what current concentration is produced by the system is a function of what electrical energy is applied to the electrode such that claim 5 recites a functional limitation. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim. Because a lower current could be applied to the instrument of Kennedy resulting in a lower current concentration, the instrument of Kennedy (as modified) recites the limitations of claim 5. However, in the interest of compact prosecution, it is noted that Kennedy does disclose ranges of values for amps and dimensions that would result in the current concentration recited in claim 5. For example, Kennedy discloses a scenario where 0.6 amps is applied over 14.84 square millimeters, resulting in about 0.040 amps per square millimeter ([0072]), but also discloses the amps can be in the range of 0.2-1.75 amps ([0013], claim 1), where applying the lower end of that range (0.2) into the example instead of 0.6 amps results in a 0.13 amps per square millimeter. Further, Kennedy also discloses the jaws can be 1-3.5 mm in width and 8-12 mm in width ([0033]), where there are combinations of those values that result in a surface area greater than 14.84 square millimeters, resulting in a lower current concentration (the example given in [0080] using the amps disclosed in [0072] results in a current concentration of 0.027 amps per square millimeter).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kennedy, Johnson and Shields, further in view of Nezhat (US 6,162,220).
Regarding claim 4, the instrument of Kennedy as modified does not disclose that the distance between the edge of the slot and the outer edge of the sealing surface is 0.2 mm or less, where that range defines the width of the tissue treating surface of the conductive tissue sealing surface. However, this is a commonly known width for tissue sealing surfaces in electrosurgical instruments, and there is no evidence that using such a commonly known width produces an unexpected result (within the meaning of MPEP 716.02(a)). Nezhat, for example, discloses an electrosurgical instrument with a tissue sealing surface having a width from 0.1-5 mm (col. 9 lines 36-64). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the instrument of Kennedy to include a tissue treating surface width (i.e. the distance between the edge of the slot and the outer edge of the sealing surface) have any width commonly known for use in electrosurgical instruments, including 0.2 such as taught by Nezhat, that would produce the predictable result of allowing a user to treat tissue in a desired manner.
Claims 6 and 7, are rejected under 35 U.S.C. 103 as being unpatentable over Kennedy, Johnson and Shields, further in view of Strobl (US 2015/0133915).
Regarding claims 6 and 7, Kennedy does not disclose one or more radii of curvature for the jaw and/or knife slot. However, curved jaws are very common in the art and there is no evidence that curving the jaws produces an unexpected result (within the meaning of MPEP 716.02(a)). The fact that Applicant claims three mutually exclusive configurations for the jaw suggests the opposite. Strobl discloses an electrosurgical instrument and teaches that a knife slot can be curved with one radius of curvature or multiple radii of curvature in a longitudinal direction ([0078], where the “curvature of the end effector” is discussed in [0074]). It has been held that a change of shape is an obvious modification (MPEP 2144.04(IV)(B)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the instrument of Johnson to have curved jaws/slots, including slots having one or more radii of curvature along the longitudinal direction, as taught by Strobl, that would produce the predictable result of a functional medical device.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kennedy, Johnson, Shields and Strobl, further in view of Merhi (US 2012/0179033).
Regarding claim 8, Kennedy does not disclose an ellipsoidal curve for the jaw and/or knife slot. However, curved jaws are well known in the art (see e.g. Strobl discussed above) and in general curved elements are very common in various kinds of ablation devices. There is no evidence that an ellipsoidal shape in a curved jaw produces an unexpected result (within the meaning of MPEP 716.02(a)). The fact that Applicant claims three mutually exclusive configurations for the jaw suggests the opposite. Merhi discloses an electrosurgical instrument and teaches that various curved shapes including circular and elliptical are considered ([0047]). It has been held that a change of shape is an obvious modification (MPEP 2144.04(IV)(B)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the instrument of Kennedy to have a curved jaw such as taught by Strobl, and further to use any commonly known type of curved shape including circular, oval, oblong, elliptical or egg-shaped as taught by Merhi, that would produce the predictable result of a functional medical device.
Claims 19 and 20, are rejected under 35 U.S.C. 103 as being unpatentable over Kennedy, Johnson and Shields, further in view of Hughett (US 2010/0185232).
Regarding claims 19 and 20, Kennedy further discloses the gap distance is between 0.1 mm and 0.2 mm ([0004]), but does not specifically disclose that the gap is larger at the proximal end of the device. Hughett discloses a forceps devices and notes that allowing a larger gap at the proximal end of the device is useful for clamping thicker tissue (fig. 8, [0074]-[0075]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify Kennedy to include a gap decreasing in the distal direction, such as taught by Hughett, that would produce the predictable result of better allowing the treatment of certain types of tissue.
Claim 23 rejected under 35 U.S.C. 103 as being unpatentable over Kennedy, Johnson and Shields, further in view of Couture (US 2015/0088128).
Regarding claim 23, Kennedy discloses the jaws comprise conductive cores (130, 132, [0046]), and teaches that they must be electrically isolated ([0048]), but does not disclose the use of pairs of non-conductive bushings. However, bushings are a very common element in electrosurgical devices. Couture, for example, discloses that one or more non-conductive bushings can be associated with either or both jaws ([0068]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the instrument of Kennedy to have any number of non-conductive bushings associated with each jaw, including two such as taught by Couture, that would produce the predictable result of electrically isolating the jaws.
Claims 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Kennedy, Johnson, Shields and Couture, further in view of Deville (US 2009/0171354).
Regarding claims 24 and 25, Kennedy discloses a shaft (unnumbered in fig. 6C) and a pin (also unnumbered in fig. 6C) but does not disclose first/second links or that the bushings are connected between the pin/links/shaft. However, the claimed configuration of shaft, links and pin are an extremely common arrangement for allowing a forceps device to open and close. Deville, for example, discloses a forceps device that includes a shaft (including at least 1310, fig. 13), a pin (1314) two links (1562, 1360, fig. 15) coupled to the jaws to allow the jaws to be opened/closed (fig. 14-15). Further, Deville teaches that electrical energy can be supplied to the jaw independently of the force translation mechanism (1450, fig. 14). It has been held that the combination of known elements according to known methods to yield predictable results, and/or the simple substitution of one known element for another, are obvious modifications (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to use any commonly known electrical connection in the instrument of Kennedy, including a wire such as taught by Deville, and any commonly known mechanical force transmission elements for opening/closing the jaws in the instrument of Kennedy, including the shaft, pin and links connected the jaws as taught by Deville, that would produce the predictable result of allowing a user to open and close the forceps jaws. Further, with this modification in view, it would also have been obvious to one of ordinary skill in the art to use non-conductive bushings in the instrument of Kennedy such as taught by Couture everywhere such bushings would prevent electrical interaction between the jaws, including between the pin and the jaws and the link and the jaws (where the links are proximal to the pin, fig. 13 of Deville, and therefore those bushings would be proximal bushings), to produce the predictable result of allowing bipolar energy to be delivered to the jaws without an electrical short circuit.
Regarding claims 26 and 27, it is not clear whether Kennedy discloses a non-conductive coating on the jaw, but such coatings are common in the art such as taught by Deville ([0151], note also the general concern for electrical isolation between jaws). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the instrument of Kennedy to have non-conductive coating everywhere other than the faces of the jaws such as taught by Deville to produce the predictable result of ensuring that only tissue grasped by the jaws is treated with energy.
Response to Arguments
Applicant's arguments filed 20 August 2026 with respect to the drawing objections have been fully considered but they are not persuasive. Applicant points to R1 and R2 to satisfy the drawing objection. But the specification states that R1 and R2 are directed to the sealing surfaces, where the objections are directed to claim language about elongated slots. The radius of the sealing surface has no clear or defined relationship to the radius of the elongated slots. For example, figures 6 and 7 show that the radius is of the sealing surface when taken along a plane perpendicular to the longitudinal axis of the device, but it is not even clear how the elongate slot could have a radius in that plane.
Applicant's arguments filed 20 August 2026 with respect to the claim 5 have been fully considered but they are not persuasive. First, the claim is a purely functional limitation as noted in the rejection, where any amount of current can be supplied to an electrode of a given size to produce any current density. Second, the arguments ignore the analysis regarding the other current values contemplated by Kennedy outside of paragraph [0072].
Applicant’s arguments with respect to the rest of the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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
