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.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 20 April 2026 has been entered.
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 53-57, 59 and 62-64 are rejected under 35 U.S.C. 103 as being unpatentable over Mayer (US 2017/0065331) in view of Latterell (US 2005/0171533) and Palanker (US 2008/0027428).
Regarding claims 54-57, 59, 63 and 64, Mayer discloses a surgical system (fig. 1) for sealing and cutting tissue including a generator (14) and a surgical device (12). The device further includes a shaft (17), actuatable jaws (16) that when closed define a longitudinal axis with two portions for sealing tissue with opposed conductive seal surface electrodes (27, 28 and 33, 34), and a cut electrode aligned with the longitudinal axis on the interior region of one jaw for cutting a third portion (26). The cut electrode is further arranged so that the cutting surface is in a cross-section perpendicular to the longitudinal axis (fig. 7). The cut electrode also has a height profile relative to the first jaw such that when the jaws are closed the surface of the cut electrode pressed a third part of tissue (i.e. a middle part of tissue between the first and second portions defined by the opposed conductive seal surfaces) into a non-conductive elastomer resilient member (35, discussed more below) to compress the third part of tissue as the resilient member imposes a restoring force that presses the third tissue portion against the surface of the cut electrode when the jaws are closed (compare figures 9A-C, [0024]-[0025]). The jaws and cutting electrode together are configured to perform the functional limitation of stretching the tissue in contact with the cutting electrode. Mayer also discloses the non-conductive (within some meaning of the word) resilient member/elastomer (35, [0042]) on the other jaw opposite the cutting electrode for compressing and thus applying continuous contact to tissue by applying a restoring force in multiple directions on the tissue to press tissue against the cutting electrode (fig. 9A-C, [0055], note continuous contact region 54 in fig. 5). The second jaw further includes a relief space under the resilient member to allow the resilient member to resiliently compress during tissue engagement to prevent gaps between the cut electrode and tissue (37, [0043], [0063], see also 63 in fig. 10 and note the progression in figures 9A-C). The first jaw further defines reservoirs on either side of the cut electrode for holding tissue when the jaws are closed (unnumbered, the space between 25 and 28 being one reservoir and the space between 25 and 27 being another reservoir, fig. 9B, see also fig. 5). Mayer further discloses that RF power signals are applied to the opposed conductive sealing surfaces and the cutting electrode to cut and seal tissue (fig. 7). The sealing electrodes operate to produce a "bipolar effect" and one sealing electrode and the cutting electrode operate to produce a "monopolar effect," where "bipolar effect" and "monopolar effect" are understood to be extremely broad rather than indefinite (however, see also fig. 7). While the language in claim 1 broad enough to be encompassed by Mayer, in the interest of compact prosecution Mayer will be interpreted to not output two distinct RF power signals. Mayer also does not disclose the cutting edge has a rounded convex cross-section. However, both these elements are common in the art and there is no evidence that the manner of using RF power signals to cut/seal tissue or a convex cutting edge produces an unexpected result (within the meaning of MPEP 716.029(a)). Regarding the RF power signals, Latterell, for example, discloses a surgical system for cutting and sealing tissue (fig. 2) and teaches that RF power signals for cutting and sealing can be delivered to cutting and sealing electrodes simultaneously ([0058]) or sequentially, sealing first ([0056]). This is understood to be a teaching of functional equivalence (MPEP 2144.06). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the system of Mayer to have any commonly known configuration of energy delivery, including the delivery of a first RF power signal for sealing followed by a second RF power signal for cutting as taught by Latterell that would produce the predictable result of allowing a user to seal and cut tissue in a desired manner. Regarding the cross-sectional shape of the blade, using a flat blade with tapering surface, insulated sides and a rounded convex edge is common in the art for electrosurgical cutting. Palanker, for example, discloses an electrosurgical cutting blade with a rounded convex cutting tip (see discussion of figs. 4A-B). It has been held that the simple substitution of one known element for another is an obvious modification (MPEP 2141(III)). Therefore, before the application was filed, it would have been obvious to further modify the system of Mayer to have any commonly known electrosurgical blade configuration, including a rounded convex cutting tip as taught by Palanker, that would produce the predictable result of allowing a user to cut tissue. This modification is understood to be applied according to the desired cutting direction of Mayer which results in the elements having the shapes in a cross-section perpendicular to the longitudinal axis (i.e. the cross-section shown in fig. 4A of Palanker matched to the cross-section shown in fig. 7 of Mayer). The limitation “substantially uniform current concentration” must be interpreted as extremely broad or indefinite, and the former is chosen. Neither the claims nor the specification define exactly what “substantially uniform current concentration” means. Further, the claims also do not define the parameters of the region in which this current concentration occurs. Applicant’s figures 8A and 8B, for example, which purport to show the difference between the invention and some hypothetical other cutting element, clearly do not show that the current concentration is uniform across the entire electric field. That is, within some arbitrarily defined volume and broad definition of “substantially uniform,” a substantially uniform current concentration exists in both figures. Therefore, the claim limitation “substantially uniform current concentration” is understood to mean that an area exists in an electric field in which the current is more similar than dissimilar. Any prior art reference that has the other claimed limitations (convex surface, electrical insulation, etc.) is understood to produce the result by definition.
Regarding claim 53, the seal surface electrode can be divided arbitrarily into one or more “tissue compression portion[s]” and one or more “first rounded edge portions,” all of which are rounded (28, 27, fig. 7 of Mayer). These rounded edges are understood to “minimize current concentrations” during energy delivery, a limitation that is understood to be extremely broad rather than indefinite.
Regarding claim 62, the system of Mayer as modified does not disclose that the cut electrode has flat, electrically insulated sides that taper to the rounded convex surface. However, use of electrical insulation on electrosurgical blades is common in the art. Palanker, for example, discloses the cutting edge includes flat, tapering surfaces (fig. 4A-B) having insulating sides (220). It is noted that Palanker shows almost exactly the same arrangement as Applicant’s figure 5D, the only differences being unclaimed (e.g. the external surfaces of the insulation being parallel). 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, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the system of Mayer to have any commonly known blade configuration, including the electrode having flat sides that taper to the rounded convex tip and include insulation, such as taught by Palanker, that would produce the predictable result of allowing the blade to cut tissue. For a reference that is closer to Applicant’s disclosed invention (including insulation with parallel external surfaces), see figure 6 of US 2017/0172646 to Patel cited in the Conclusion of the previous Action.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Mayer, Latterell and Palanker, further in view of Kennedy (US 2011/0319882).
Regarding claim 43, the system of Mayer does not disclose the specific values used for sealing because such values are well within the level of ordinary skill in the art to determine. Further, impedance as a feedback parameter borders on ubiquitous in the art. Kennedy, for example, discloses a system for sealing tissue and teaches that impedance is sensed and used to control the output of energy, where the power, voltage and current are kept within ranges that at least overlap with the claimed ranges ([0014], [0061], [0065] and [0073], see also fig. 8). Therefore, before the application was filed, it would have bene obvious to one of ordinary skill in the art to further modify the system of Mayer to use any electrical parameters commonly known to be useful for sealing tissue, including 55 watts or less, 2.5 amps or less and 110 volts or less, and further to use impedance to control the output of energy during the sealing phase, both taught by Kennedy, that would produce the predictable result of allowing a user to seal tissue in a desired manner.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Mayer, Latterell and Palanker in view of Mathonnet (US 2010/0204696), Nardella (US 5,665,085), Ormsby (US 2006/0095031) and Wham (US 2005/0203504).
Regarding claim 44, the system of Mayer does not disclose the specific values used for cutting because such values are well within the level of ordinary skill in the art to determine. Further, impedance as a feedback parameter borders on ubiquitous in the art. Mathonnet, for example, discloses tissue cutting can be produced at 1-300 watts ([0040]), Nardella discloses tissue cutting can be provide at 0.5-2 amps (claim 20), and Ormsby discloses tissue cutting can be provided at 5-100 volts ([0064]). Regarding impedance-based control, Wham, for example, teaches that several values including voltage, current and power can be controlled on the basis of several values including impedance ([0011]). Therefore, before the application was filed, it would have been obvious to further modify the system of Mayer to employ, or allow a user to dictate, maximum and minimum operating parameters, such as those disclosed by Mathonnet, Nardella and Ormsby, and further to employ impedance-based control of those or other operating parameters, such as taught by Wham, that would produce the predictable result of allowing a user to cut tissue in a desired manner.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Mayer, Latterell and Palanker, further in view of Mathonnet, Guerra (US 2007/0260238) and Wham.
Regarding claim 45, the system of Mayer does not disclose the use of a cutting power greater than seal power, where power is maintained by changing voltage or current in response to impedance changes. However, all these elements are commonly known in the art. Regarding the use of a cutting power higher than a seal power, see Mathonnet ([0040]). Regarding holding power constant by changing current or voltage, see Guerra ([0040]). Regarding using impedance to control voltage, current and power, see Wham ([0011]). Therefore, before the application was filed, it would have been obvious to further modify the system of Mayer to include a cut power higher than a seal power as taught by Mathonnet, to maintain power by changing voltage or current as taught by Guerra, in response to impedance measurements as taught by Wham, that would produce the predictable result of allowing the system to treat tissue in a desired manner.
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
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
Prosecution Insights