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 § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 5, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Konishi (US 2016/0249975).
Regarding claims 1, 2, 5, 19 and 20 Konishi discloses an electrosurgical instrument with a housing, shaft and end effector (figs. 1 and 18) including jaws at least one of which has multiple electrodes (91) and two, longitudinally arranged/aligned/offset thermal cutting elements which extend substantially the entire length of a zone defined between the electrodes (fig. 18, cutter 15 having two cutting elements, 13A and 13B, fig. 6). More specifically, while the cutting elements (13A and 13B) are located on a continuous surface (13), the cutting elements (13A and 13B) are separated by a gap where the third current supply portion (43) is located because current moves between the first and third current supply portions (41 and 43, respectively) or between the second and third current supply portions, (42 and 43, respectively). Thus, as can be seen in figures 6, 8 and 9, there exists a cutting gap in the continuous surface such that the cutting elements are separated by a gap. Every forceps device is “adapted to” connect to an arm of some hypothetical robotic surgical system.
Claims 1, 2, 10 and 19-22 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Honda (US 2016/0310207).
Regarding claims 1, 2, 10 and 19-22, Honda discloses an instrument with jaws (13a, 13b, figs. 5-6) each having respective electrodes (23a1, 23b1) and multiple, longitudinally spaced, respective thermal cutting elements (26a, 26b) that do not overlap when the jaws are closed ([0047]). Honda also discloses the instrument includes a housing and a shaft (fig. 1), where any instrument is “adapted to” connect to an arm of some hypothetical robotic surgical system.
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, 2, 5-8, 10, 13-22 are rejected under 35 U.S.C. 103 as being unpatentable over Konishi (US 2016/0249975) in view of Anderson (US 2012/0059371).
Regarding claims 1, 2, 5, 19 and 20, Konishi, as discussed above, discloses the limitations recited by the claims. However, in the interest of compact prosecution, Konishi will here be treated as though element 13 is a single cutting element. Cutting elements in forceps are ubiquitous and well within the level of ordinary skill in the art. Further, there is no evidence that the claimed cutting element configuration is critical or produces an unexpected result (within the meaning of MPEP 716.02(a)), where the fact that Applicant has both disclosed and claimed mutually exclusive cutting element configurations suggests the opposite, that the cutting elements do exactly and only what a person of ordinary skill in the art would expect. Anderson discloses a forceps device with two longitudinally separated cutting elements (127 and 137, fig. 3A). Further, Anderson teaches what would be self-evident to a person of ordinary skill in the art, that either electrode can be located on “one or both” jaws for performing exactly the same function (e.g. [0009]). 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 element is simply where blades are located on a jaw. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the instrument of Konishi to include an additional cutting element separated by a gap from the original cutting element, such as taught by Anderson, that would produce the predictable result of allowing a user to cut tissue with the cutting elements.
Regarding claim 10, the instrument of Konishi as modified does not include a third cutting element. However, duplication of parts has been held to be an obvious modification (MPEP 2144.04(VI)(B)). Therefore, before the application was filed, it would have been obvious to further modify the instrument of Konishi with at least one additional cutting element that would produce the predictable result of allowing a user to cut tissue.
Regarding claims 13-18, these claims recite mutually exclusive characteristics of how the heater is constructed. However, all the claimed heater constructions are commonly known in the art (as shown in the Conclusion below) and there is no evidence that using any of them produces an unexpected result. Thus, the examiner takes official notice that these types of heaters are both common and trivial, and thus well within the level of ordinary skill in the art. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to provide the heaters of Konishi as any commonly known types of heaters including ferromagnetic cutting wires configured to employ Curie temperatures or aluminum oxide substrates with heating layers, that would produce the predictable result of an instrument with thermal cutting elements. It is noted that “PEO” is a product-by-process limitation (MPEP 2113). Further, thermal cutting elements are thermally conductive by definition and no part of any thermal cutting element is entirely in contact with tissue (because purely two-dimensional objects do not exist), such that any configuration of thermal cutting element including one which uses a substrate and a heating layer is “configured to” establish a thermal gradient from any part of the thermally conductive thermal cutting element to any other part of the thermally conductive thermal cutting element.
Regarding claim 21, 6 and 7, the instrument of Konishi as modified by Anderson discloses all the features as discussed above except that each cutting element is on a different jaw. However, as noted above, Anderson teaches that each electrode can be located on either or both jaws (see also [0039]), thus establishing that a person of ordinary skill in the art would recognize that whether a cutting element is located on one or both jaws does not significantly impact the cutting function of the instrument. Further, Anderson shows that the electrodes are aligned and therefore “complementary” to one another (figs. 4A-D). It has been held that choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success, is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to further modify the instrument of Konishi to include any of the cutting element configurations as taught by Anderson, including one cutting element on each jaw that do not overlap when the jaws are closed, that would produce the predictable result of allowing a user to use the instrument to cut tissue.
Regarding claim 8, the instrument of Konishi as modified does not show that the cutting elements are different widths. However, Anderson further shows that the cutting elements can be different widths (fig. 3A). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the cutting elements of Konishi with at least one additional cutting element that would produce the predictable result of allowing a user to cut tissue.
Regarding claim 22, the instrument of Konishi as modified does not include a third cutting element. However, duplication of parts has been held to be an obvious modification (MPEP 2144.04(VI)(B)). Therefore, before the application was filed, it would have been obvious to further modify the instrument of Konishi with at least one additional cutting element that would produce the predictable result of allowing a user to cut tissue.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Konishi and Anderson, further in view of Lau (US 2006/0217706).
Regarding claims 11 and 12, the instrument of Konishi even when modified as discussed above does not disclose that one of the thermal cutting elements wraps around a distal tip of one of the jaws. However, tissue treatment elements that wrap around jaws are common in the art and there is no evidence that the claimed configuration produces an unexpected result. Lau, for example, discloses an instrument with a heating element that wraps around a distal tip of one of the jaws (fig. 35B). Therefore, before the application was filed, it would have been obvious to further modify the instrument of Konishi to extend the more distal of the cutting elements to wrap around the distal tip of a jaw, such as taught by Lau, that would produce the predictable of allowing a user to treat tissue outside the jaws.
Response to Arguments
Applicant’s arguments with respect to 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding the general teaching that a single, long cutter can be used to cut tissue or that multiple smaller cutters can be used to cut tissue, see figures 5 and 6 of US 2018/0008298 to Drochneer and figures 2 and 5 of US 2012/0041438 to Nau.
The following references were cited in the previous Action but are listed here for ease of reference: Regarding a ferromagnetic thermal cutting element which employs a Curie temperature for automatic temperature control, see for example paragraph [0062] of US 2013/0158535 to Denis. Regarding the use of a heating layer located on an aluminum oxide substrate, see for example paragraph [0072] of US 2013/0150848 to Yasunaga. Regarding other instruments with relevant heaters, see figure 4 of US 2006/0217706 of US 2006/0217706 to Lau. Regarding the functional equivalence of a dynamic cutting element in a forceps jaw and a static cutting element in a forceps jaw, compare figures 4A and 6B of US 2014/0180281 to Rusin. Regarding the use of a plurality of heaters in one cutting element, see figures 10A-D of US 7,025,763 to Karasawa. Regarding radially offset thermal cutting elements, see figure 5 of US 5,792,137 to Carr.
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).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANIEL W FOWLER/Primary Examiner, Art Unit 3794