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 .
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 1-5, 9, 10, 12, 13, 15-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Heim et al (7,896,875) in view of the teachings of Robinson et al (10,709,497) and Fairbourn et al (9,913,947).
Heim et al disclose a surgical device comprising a longitudinal shaft (51) for at least partial insertion into a patient, and an end effector (40) on the distal portion of the shaft. See, for example, Figure 26. The end effector is configured to cut tissue (col. 4, lines 55-60, for example) and comprises a first, second and third electrodes (3,4,5 – Figure 1, for example) with a first insulation element (6) positioned between the first and second electrodes (3,4) and a second insulation element (6) positioned between the second and third electrodes (4,5) to allow for bipolar cutting of tissue (col. 8, lines 20-25). Heim et al fails to expressly disclose a non-stick layer covering the device, in particular, only the insulation layer.
Robinson et al, as addressed in the previous Office actions, provide a surgical device comprising a longitudinal shaft (12) having an end effector (110,120) on the distal portion of the shaft. The end effector includes an electrode (312,322) and an insulation element (316). A non-stick layer is provided over the insulation element (col. 5, lines 60-65, for example). The non-stick layer may be polydimethylsiloxane or hexadimethylsiloxane (col. 6, lines 18-27) and would therefore have the property of having a surface adherence to tissue that is less than a surface adherence to tissue of the material of the insulation element as claimed. Robinson et al also teach the coating may be provided on other parts of the end effector (e.g. on an electrode), similar to applicant’s own disclosure.
Fairbourn et al is cited to teach that it is known to coat both electrosurgical forceps (as taught by Robinson et al) and spatula/hook devices (as taught by Ichikawa et al) with a similar siloxane coating, thereby providing a nexus for the combination of providing the Robinson teaching of a siloxane coating on the hook shaped electrode of Ichikawa et al, and specifically a coating on only the insulation portion of the device.
To have provided the Heim et al device with a non-stick coating over the insulation element to prevent tissue from adhering to the insulation surface during use would have been an obvious design consideration for one of ordinary skill in the art at the time of the invention since Robinson et al fairly teach the known use of such a coating on an electrosurgical end effector, and specifically on individual components of the end effector such as an insulator. The combination is further made obvious by the teaching of Fairbourn et al who teach that such a coating may be provided on a variety of different devices including blades, hook-shaped devices and forceps jaws alike.
Regarding claim 2, see Robinson et al at column 6, lines 18-27 as referenced above. Regarding claim 3, see Robinson et al at column 7, lines 10—20, for example). Regarding claim 4, see Robinson et al at column 7, lines 26-27. Regarding claim 5, the non-stick layer is continuously applied to the jaw members as disclosed by Robinson et al, and would intuitively be similarly provided on the Ichikawa et al end effector. Regarding claim 9, the same material is used for the Robinson et al non-stick coating and therefore has the same non-conductive properties. See, also, column 6, line 60 which discusses the dielectric nature of the coating. Regarding claim 10, there are a plurality of insulation elements including the insulation layer (96) of Ichikawa et al, and the coating which is also an insulation element. Regarding claims 12 and 13, again the same material used by Robinson et al is the material disclosed and claimed by applicant and would have the same hydrophobic properties. Regarding claim 15, the Ichikawa et al end effector may have a variety of shapes, including scalpel blades, J-hooks or spatulas (col. 4, lines 40-45, for example).
Regarding claim 16, Heim et al, as addressed above, provides a device comprising an end effector having first, second and third electrodes, each electrode separated by an insulator from an adjacent electrode to provide bipolar cutting of tissue. Robinson et al provide the teaching of applying a non-stick layer to an insulation element of an end effector as addressed previously. The non-stick layer of Robinson et al may be a polydimethylsiloxane or hexadimethylsiloxane, which coatings are known to be hydrophobic (as applicant’s specification acknowledges). As addressed previously, Fairbourn et al provide the teaching that it is known to coat a variety of different electrosurgical end effectors, including spatula/J-hook instruments and forceps, with a similar non-stick coating.
To have provided the Heim et al device with a non-stick coating over the insulators of the end effector to prevent tissue from adhering to the end effector surface during use would have been an obvious design consideration for one of ordinary skill in the art at the time of the invention since Robinson et al fairly teach the known use of such a coating on an electrosurgical end effector. The combination is further made obvious by the teaching of Fairbourn et al who teach that such a coating may be provided on a variety of different devices including hook-shaped devices and forceps jaws alike.
Regarding claims 17 and 19, Robinson et al disclose depositing a coating using a chemical vapor deposition process (col. 6, lines 30-40, for example), which coating process is deemed an intuitive and obvious process for coating the Ichikawa et al device.
Claims 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Heim et al (‘875) in view of the teachings of Robinson et al (‘497) and Fairbourn et al (‘947), and further in view of the teaching of Milbocker et al (2018/0236511).
Robinson et al provide a non-stick layer as addressed previously, but fail to expressly disclose providing hydrophobic pillars on the surface.
Milbocker et al disclose another coating for application to a substrate to create a hydrophobic pillars. See, for example, the abstract. Such pillars would further create asperities in the surface as recited in applicant’s claim 8.
To have provided the Robinson et al coating with hydrophobic pillars to create a desired hydrophilicity to the surface would have been an obvious consideration for one of ordinary skill in the art since Milbocker et al disclose the use of such pillars to control the hydrophilicity of a coating on a substrate. The combination of such a coating with the Heim et al end effector, as evidenced by the teaching of Fairbourn et al, has been addressed previously.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Heim et al (‘875) in view of the teachings of Robinson et al (‘497) and Fairbourn et al (‘947), and further in view of the teaching of Lin et al (2021/0403755).
Robinson et al fail to teach the coating comprises nanoparticles. In a similar field of coatings, Lin et al teach that dimethylsiloxane coatings may be provided as a nano-particle polymer (Abstract, for example) to protect metal surfaces from corrosion.
To have provided the Robinson et al coating as a nanoparticle polymer coating would have been an obvious consideration for one of ordinary skill in the art since Lin et al teach that it is known to provide similar coatings as a nanoparticle polymer for coating a metal device to prevent corrosion. The combination of such a coating with the Heim et al end effector, as evidenced by the teaching of Fairbourn et al, has been addressed previously.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Heim et al (‘875) in view of the teachings of Robinson et al (‘497) and Fairbourn (‘947) and further in view of the teaching of Ricart et al (6,772,012).
Heim et al disclose various different materials for providing the insulation between the electrodes, but fails to expressly disclose the use of silicone rubber as the insulation material. The examiner maintains that it is generally well-known in the art that silicone rubber may function as an insulator. To that end, Ricart et al provide another electrosurgical device and insulates electrodes with an insulator. Ricart et al teach of a variety of different well-known materials, including silicone rubber, that may be used as the insulative component. See, for example, column 5, lines 52-60.
To have provided the Heim et al device with a silicone rubber as the insulator would have been an obvious design consideration for one of ordinary skill in the art since Ricart et al fairly teach that silicone rubber is a known insulator and an obvious alternative to numerous other well-known insulating materials. The motivation for the combination of the Robinson et al and Fairbourn teachings has been addressed in previous rejections.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Heim et al (‘875) in view of the teachings of Robinson et al (‘497) and Fairbourn (‘947) and further in view of the teaching of Prausnitz et al (8,690,865).
Robinson et al fail to specifically disclose etching the surface of the coating. In a similar field of endeavor, Prausnitz et al teach that it is fairly known to etch surfaces before applying a coating to the surface (col. 9, line 64 to col. 10, line 5). To have etched the Heim et al surface prior to providing a coating as taught by Robinson et al and Fairbourn et al prior to applying the coating to assist in adhering the coating to the surface would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Prausnitz et al fairly teach this process.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Heim et al (‘875) in view of the teachings of Robinson et al (‘497) and Fairbourn et al (‘947) and further in view of the teaching of Heim et al (7,377,919).
Robinson et al disclose the chemical vapor deposition of the non-stick layer to the device, but fail to expressly disclose a process of physical vapor deposition for applying the layer. The examiner maintains that the various means for applying coatings are generally known to those of ordinary skill in the art. To that end, Heim et al (‘919) disclose the use of chemical vapor deposition and physical vapor deposition, among other processes, to apply coatings to an electrosurgical instrument (col. 4, lines 50-60, for example). To have provided the non-stick coating to the Heim et al (‘875) device, as taught by the teachings of Robinson et al and Fairbourn et al, using a physical vapor deposition process would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Heim et al (‘919) fairly teach it is known to use such a process as an obvious alternative to chemical vapor deposition to apply coatings to an electrosurgical instrument.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/April 28, 2026
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