CTNF 18/814,478 CTNF 81714 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Objections 07-29-01 AIA Claim 2 is objected to because of the following informalities: “and” should be inserted between “(ii) sanding using sand paper, and (iii) applying a chemical treatment.” Appropriate correction is required. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-21-aia AIA Claim (s) 1-7 and 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arts et al. (US 5702387) in view of Morris et al. (US 5380320) and Euro Inox, “Roughness Measurements of Stainless Steel Surfaces.” As to claim 1, Arts et al. discloses a method for making an electrode for an electrosurgical pencil (see abstract, col. 1, lines 1-28), wherein the electrode comprises an elongated body made of a conductive material (stainless steel, see Fig 1, col. 4, line 41-42 and examples) extending in an axial direction from a proximal end to a distal end, the proximal end receives the electrosurgical energy and the distal end forming a blade for cutting or coagulating tissue (see col. 1, lines 13-20). Arts et al. further discloses providing the elongated body with two main surface portions on opposite sides of an axially extending plan and joined by an edge extending through the plane ( major surfaces 14 and edges 15 of Figs.), roughening the main surface portions to a roughness of 50-250 micro-in Ra (see col. 4, lines 41-52), about 1.27-6.35 Ra, and coating the surface with a surface coating (silicone coating- see col. 4, lines 58-63). Arts et al. states the blade has a non-uniform coating where the major surfaces (14 of Figs) has a silicon coating while the edges (15 of Figs.) are uncoated (see col. 5,lines 3-7). Arts et al. fails to explicitly state that a mask is applied to the smooth part of the edge and roughening the surface while the mask is applied to have a roughness of 2 to 4.0 Ra and the second surface (smooth part) has a roughness of 0.5 to 1.5 Ra as required by claim 1. Morris discloses a process for coating an electrosurgical instrument having a conductive elongated member for connecting external power to the proximal end, an electrosurgical energy at the end of the elongated member. The process comprises masking the portion that is to remain uncoated; roughening the unmasked portion and then dipping in a liquid silicone to form the silicon coating which provides insulation from the electrosurgical energy (see abstract, Fig. 3 and 4). Morris further teaches the masking can be achieved by using tape or fixtures to mask the portion of the instrument (see col. 5, lines 48-53). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the process of Arts to include the masking process of Morris. One would have been motivated to do so since both references are directed to partially coating the surface of an electrosurgical blade to reduce sticking while preserving desired conductive cutting regions, and Morris teaches an operable selective masking technique for achieve such partial coating. As to the main surface having a roughness of 2.0 to 4.0 Ra, Arts teaches the roughness of the surface can be in the range of 50-250 micro-in Ra ( about 1.27- 6.35 Ra - see col. 4, lines 41-52) which overlaps that of the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). As to the limitation of the second surface roughness of the smooth part is in the range of 0.5 to 1.5 Ra, Arts teaches the coated portion is roughened while the masked edge portion remains untreated and therefore retains its initial surface condition. Morris teaches the instrument may be formed of stainless steel (e.g. 304 series stainless steel; see examples). Euro Inox teaches untreated/polished stainless steel conventionally exhibits roughness values in the lower range such as 2B finished having a roughness of 0.3 – 0.5 Ra; no. 4 finish is up to 0.6 Ra; 120 grit having 1.32 Ra, which overlaps the claims range of 0.5 – 1.5 Ra. Thus, it would have been obvious that the untreated/masked stainless steel edge would exhibit roughness values within the claimed range since the base materials conventionally exhibits such roughness values while the roughened major surfaces would exhibit higher roughness values within the claimed range. As to claim 2, Arts et al. states the roughening treatment can include sane blasting with aluminum oxide grit or chemical etching (see col. 4, lines 48-52). As to claim 3, Arts teaches the silicone is applied by oriented the instrument in a downwards direction; dipping the working area in a liquid non-stick material at a controlled rate; withdrawing the instrument from the material; allowing excess material to drip downwards; inverting the electrode; and curing the material (see col. 2, lines 46-49, col. 5, lines 3-20, and Example 4). Arts does not explicitly state removing the liquid silicone from the edge as required by the claim. However, since Arts teaches the instrument can be coated on the major surfaces where the blade is uncoated, it would have been obvious to remove the liquid from the edge portion prior to curing. dipping the instrument in a silicone elastomer by (see col. 2, lines 46-49) and curing the coating (see examples). Art further teaches the coating thickness is intentionally non-uniform and thinner at the edge than on the major surfaces (see col. 5, lines 3-20). As to claim 4, Arts et al modified by Morris teaches masking the portions of the instrument and then performing the roughening and coating (see Morris col. 5, line 48-68). As to claim 5, Arts et al. further teaches the coating thickness on the surfaces can differ, where a thicker coating is applied on the main surface portions and a thinner layer is formed on the edge portion. Arts et al. further teaches the roughening of the surface improves adhesion of the coating to the surface, therefore it would have been obvious in the case where the differing thickness of the layer is formed, to provide a rougher surface on the main surfaces (masking during roughening) to allow more coating material to adhere thereto. As to claim 6, Arts teaches the non-uniform coating where the major surfaces receive a thicker coating and a thinner or no coating on the edge portion (see Arts col. 5, lines 1-20). Arts et al. fails to teach the difference in thickness is 1.1 to 1.3 times as required by the claim. However, the coating is provided to prevent tissue adherence from the major surfaces while maintaining the conductive cutting surface of the device. The thickness is therefore a result effective parameter. It would have been obvious to one having ordinary skill in the art to maintain the claimed relative thickness on the major surfaces and edge surface in order to provide the device with the desired properties. As to claim 7, Arts et al. teaches the electrode is heated to cure the coating (see col. 4, line 12-13). As to claim 12, Arts et al. teaches the outer surfaces are roughened to improve the adhesive of the primer material and the tip of the electrode remains coated after roughening (see Fig. 3). As to claim 13, the edge forms two axial edges extending in the axial direction, one tip edge terminating the blade in the distal end, wherein the smooth part is at least part of the axial edges and tip edge (see Arts Fig. 1). As to claim 14, the surface coating is silicone coating which inherently has lower friction than that of stainless steel (the edge does not have the coating). As to claim 15, the surface coating comprises silicone (see col. 4, lines 59-60). As to claim 16, Arts et al. further teaches the thickness of the coating can be varied (see col. 5, lines 3-20). As to claim 17, Arts et al. teaches the smooth edge portion has a second surface roughness that is less than the first roughness. Arts et al. fails to explicitly state the second roughness is less than half of the first surface roughness as required by the claim. However, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Arts et al. as modified above by Morris and Euro Inox to use a second roughness that is less than half the roughness of the first roughness, in order to maintain the desired conductive cutting surface while ensue adequate application of the coating on the major surfaces to provides the desired protection. As to claim 18, Arts et al. teaches the edge forms two axial edges extending in the axial direction, and one tip edge terminating the blade in the distal end (see Fig. 1 and 2), wherein the transition between the main surface portion forms an axial corner, where in a transition between each main surface and tip edge forms a tip corner, and where the at least one tip corner and axial corner are uncoated (see col. 5,lines 1-20). PNG media_image1.png 384 732 media_image1.png Greyscale As to claim 19, Arts et al. teaches where the edge forms two axial edges extending in the axial direction, and one tip edge terminating the blade in the distal end (see Fig. 1 and 2), wherein a transition between each main surface portion and each axial edge forms an axial corner, wherein a transition between each main surface portion and the tip edge forms a tip corner, and wherein the tip corner and the axial corners are uncoated (see col. 5, line 1-20). As to claim 20, the two main surfaces have greater surface are than the edge (see Fig. 1, and two main surfaces are roughened to a higher degree) . 07-21-aia AIA Claim (s) 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arts et al. (US 5702387) in view of Morris et al. (US 5380320) and Euro Inox, “Roughness Measurements of Stainless Steel Surfaces” as applied to claim 1 above, and in further view of Jones et al. (US 6132427) . The teachings of Arts modified by Morris and Euro Inox are as stated above. Arts modified by Morris and Euro Inox fail to teach polishing a first part of the edge and not polishing a second part of the edge to provide a first edge roughness and a second edge roughness, wherein the second edge roughness is lower than the first edge roughness as required by claim 8. Jones et al. teaches an electrosurgical blade fabricated by first roughening the blade substrate, by grit blasting, and then buffing the cutting edge to create an exposed surface in whole or in part. Jones further teaches that the flat region of the blade may optionally be buffed as well showing the different portions of the blade can have different surface finishes (see col. 3, lines 11-16, col. 4, lines 56-63). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the process of Arts et al modified by Morris and Euro Inox to selectively polish one portion of the edge and not polish another portion of the edge to provide different edge roughness, because Jones expressly teaches selective buffering of edge regions of an electromagnetic blade to alter the exposed cutting surface and thereby tailor blade performance. As to claims 9 and 10, Jones teaches the first part of the edge and the second part of the edge and then polishing the surface to make the second part uncoated (see co. 3, lines 11-16). As to claim 11, Arts et al. modified by Morris, Euro Inox and Jones et al. fails to teach the claimed surface roughness. However, Euro Inox shows the roughness of a bare stainless steel can be 0.1 to 1.32 Ra which overlaps the range of claim 1 and further polishing will result in a smoother exposed edge (lower Ra). Selecting the roughness values within the claimed range would have been obvious to one having ordinary skill in the art through routine experimentation to optimize the degree of polishing/buffing needed for the surficial instrument to properly perform cutting. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cachet I Proctor whose telephone number is (571)272-0691. The examiner can normally be reached Monday-Friday 7-3 pm. 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, Michael Cleveland can be reached at 571-272-1418. 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. /CACHET I. PROCTOR/ Examiner Art Unit 1712 /CACHET I PROCTOR/ Primary Examiner, Art Unit 1712 Application/Control Number: 18/814,478 Page 2 Art Unit: 1712 Application/Control Number: 18/814,478 Page 3 Art Unit: 1712 Application/Control Number: 18/814,478 Page 4 Art Unit: 1712 Application/Control Number: 18/814,478 Page 5 Art Unit: 1712 Application/Control Number: 18/814,478 Page 6 Art Unit: 1712 Application/Control Number: 18/814,478 Page 7 Art Unit: 1712 Application/Control Number: 18/814,478 Page 8 Art Unit: 1712
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