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 .
Response to Arguments
Applicant's arguments filed 6/16/2026 have been fully considered but they are not persuasive. In response to applicant's argument that it would not have been obvious to modify McJames in view of Kato and Granger to arrive at the claimed device because the prior art did not recognize that the different colors provided by the portion of the needle with the passivation film and the portion of the needle with the passivation film and silicone layer allows a user to visually detect when the silicone is peeling off, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant also asserts that there is no reasonable expectation of success when modifying McJames in view of Kato and Granger. This is not found persuasive. Kato discloses that stainless steel can be colored by applying a specific power source using a square wave in an acidic solution containing no hexavalent chromium (see abstract and [0010]). A stable passivation film is formed on the stainless steel (stable oxide film; [0008]-[0010]), and by changing the various conditions of the square wave, it is possible to produce the film in colors such as blue, brown, and black ([0010]). Because the needle of McJames is made of stainless steel, one skilled in the art would have had a reasonable expectation when using the method of Kato to color the needle blue, noting that the primary purpose of the coloration of the needle is to provide a needle more readily observed by surgeons than conventional shiny needles as noted by McJames (col. 1, ll. 54-59), and a passivation film of blue provides the same dulling effect as a black passivation film as understood by one of ordinary skill in the art. One skilled in the art would have been motivated to use the method of Kato when applying a passivation film to the device of McJames in order to negate the use of substances that have a severe environmental impact. Granger teaches a method of adding a silicone coating to a needle that includes leaving a shank portion of the needle uncoated (by the silicone) in order to avoid blocking the recess of the needle that receives the suture. Because the passivation film colors the needle blue as taught by Kato, and the portion of the needle covered by the silicone will appear black due to the silicone optically adjusting the color in the same manner as the instant invention, the prior art of McJames in view of Kato and Granger meets the limitations of the claims.
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.
Claim(s) 5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over McJames, II et al. (US 5,935,138; “McJames”) in view of Kato (JP 2013-241664A; copy with translated abstract provided by applicant on 8/25/2021; a translation of the rest of the document provided by the office with previous action dated 3/5/2025) and Granger et al. (US 5,258,013).
McJames discloses a black-colored medical device comprising a stainless-steel suture needle (abstract; col. 4, ll. 10-15 and 51-57) having a passivation film thereon (oxidation of surface; col. 6, ll. 3-20). McJames further discloses a layer of silicone on the surface of the passivation film (col. 6, ll. 27-35). McJames discloses applying the silicone in a manner that does not fill a recess (14) in the needle (col. 6, ll. 20-27). The silicone is considered an optical adjustment layer as silicone is known to absorb and refract light, noting also that claim 7 claims that the optical adjustment layer is silicone. McJames fails to disclose that the passivation film contains none of hexavalent chromium, cyanide, or lead (noting the use of sodium dichromate in col. 6, ll. 9-11) such that the passivation film is colored from dark brown to blue. Note: the range “dark brown to blue” is understood to include dark brown, reddish purple and blue in view of par. [0020] of the instant application.
Kato discloses that stainless steel can be colored by applying a specific power source using a square wave in an acidic solution containing no hexavalent chromium (see abstract and [0010]). A stable passivation film is formed on the stainless steel (stable oxide film; [0008]-[0010]), and by changing the various conditions of the square wave, it is possible to produce the film in colors such as blue, brown, and black ([0010]). The passivation film contains none of hexavalent chromium, cyanide or lead (see entire document, esp. [0010], [0020], and noting no lead or cyanide are used in the process). It would have been obvious to one of ordinary skill in the art to have modified the prior art stainless steel suture needle of McJames to provide a passivation film formed via the method taught by Kato instead of that disclosed by McJames in order to negate the use of substances that have a severe environmental impact ([0007] of Kato). As taught by Kato, the passivation film may be made blue ([0010], [0017]). It would have been obvious to have colored the passivation film on the needle of McJames as modified in view of Kato to be blue as taught by Kato since the primary purpose of the coloration of the needle is to provide a needle more readily observed by surgeons than conventional shiny needles as noted by McJames (col. 1, ll. 54-59), and a passivation film of blue provides the same dulling effect as understood by one of ordinary skill in the art.
According to the instant application, a layer of silicone over a needle with a blue or brown passivation film formed on stainless steel results in the needle appearing black where the passivation film is present (see [0021] of instant application as filed 8/25/2021). Therefore, it is understood that the needle of McJames in view of Kato, which comprises a stainless-steel needle having a passivation film colored blue as taught by Kato and covered with a layer of silicone as disclosed by McJames, will have a silicone layer that is “blackened” (i.e., the needle will appear black) in the same manner as the instant invention (see [0021] of instant application).
McJames in view of Kato fails to disclose that the needle has an uncoated part the same color as the passivation film (i.e., an uncoated part having the passivation film, but not the silicone).
Granger discloses that it is known to coat needles with silicone by inserting the needle shank end into a support block of rigid foam and thereafter spraying the siliconization fluid to the exposed surface of the needle (col. 3, ll. 62-col. 4, ll. 33). Since the shank end of the needle is embedded in the support block, it remains free of silicone, which advantageously prevents silicone from entering the recess at the end of the needle (col. 3, ll. 62-col. 4, ll. 33).
It would have been obvious to one of ordinary skill in the art to have modified the prior art of McJames to apply the silicone on the needle, which includes a blue passivation film over its outer surface as taught by Kato, using the spray method taught by Granger such that an end portion of the needle remains uncoated with silicone, since such a method allows the bore occluding step disclosed by McJames (col. 6, ll. 20-27) to be totally omitted according to Granger (see col. 3, ll. 65-col. 4, ll. 30 of Granger). With such a modification, the uncoated portion of the needle (i.e. uncoated by silicone) will have the same color as the passivation film (i.e., blue as taught by Kato, which is applied to entire needle as disclosed by McJames) since it is not covered with silicone (which optically adjusts blue passivation film to appear black).
Conclusion
THIS ACTION IS MADE FINAL. 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 KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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KSH 7/27/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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