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 .
Claim Rejections - 35 USC § 103
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.
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.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundy et al. (US 6,098,616, hereinafter “Lundy”).
Regarding claims 1, 4, 7-8, 11, 14-15, 18-19, Lundy discloses the invention substantially as claimed including a device comprising an external nasal dilator (10) and method of forming an external nasal dilator configured to adhere across a bridge of a human nose (Figs 3-7) and apply a recoil force to outer walls of nasal passages of the human nose (column 3, lines 30-47; col 5, ln 35-43),
the external nasal dilator having (a) a base layer (20) with an adhesive for adhering the external nasal dilator to a human nose (col 5, ln 8-9); (b) a resilient layer (15) that applies a recoil force to the human nose when adhered thereto (col 3, ln 38-47); (c) and a cover layer (23) over the resilient layer (col 3, ln 66- col 4, ln 13), the base layer, resilient layer, and cover layer being laminated together (col 6, ln 12-39), and packaging including a release liner (liner 52) contacting the external nasal dilator, the packaging being a non-transparent second color (paper backing - col 6, ln 40-47; silicone coated kraft paper – col 7, ln 9-10; bleached Kraft-Glassine paper, silicone coated – col 5, ln 20-21).
Lundy teaches “In different embodiments, there are situations where at least one of, and preferably all of the components, namely pad, adhesive and spring are substantially transparent, translucent, clear, a flesh-like color or shade so as to effectively blend with the skin of wearer.” (col 2, ln 24-28; see also col 8, ln 1-8). Lundy additionally teaches the pad may be selectively non-transparent or the spring may be non-transparent to be seen through a transparent pad (col 8, ln 10-22). “The dilator may can be printed and/or tinted by any known process” (col 8, ln 22-23).
Lundy does not specifically teach the external nasal dilator has a transparent tinted portion that is tinted a first color, the packaging being non-transparent and having a second color that contrasts with the first color, wherein the first color is visually perceptible through the transparent tinted portion when the packaging is contacting the external nasal dilator and is visually imperceptible when the external nasal dilator is adhered across the bridge of the human nose. However, Since Lundy discloses the dilator can be made from a transparent material or can comprise a flesh-like color or shade so as to effective blend with the skin of the wearer and can be printed and/or tinted by any known process in combination with the teaching that the release liner can be a paper backing or silicone coated kraft paper, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try modifying the dilator of Lundy, with a transparent tinted portion on a part of the base, cover or resilient layer that is tinted a first color wherein the first color is visually perceptible through the transparent tinted portion when the packaging is contacting the external nasal dilator (transparent tinted portion visual on paper backing or bleached kraft paper) and is visually imperceptible when the external nasal dilator is adhered across the bridge of the human nose (matching the flesh-like color or shade), for the advantage of improving the ability of the dilator to conform to a flesh color or tone (col 4, ln 21-24), as a person with ordinary skill has good reason to pursue the known options within his or her technical grasp and since it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success. Furthermore, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claims 2-3, 9-10, and 15-16, Lundy fails to disclose the transparent tinted portion has an opacity of 0.1%-20% or has an opacity of 0.1%-10%. However, since Lundy teaches the dilator is transparent so that it blends with the nose color and is substantially invisible (col 2, ln 24-27, col 8, ln 1-8) or may be tinted a flesh-like color or shade (col 2, ln 27-28; col 4, ln 21-24), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Lindy such that the transparent tinted portion has an opacity of 0.1%-20% or has an opacity of 0.1%-10%, for the advantage of having a transparency level that renders the nasal dilator invisible on the nose (col 4, ln 21-24) and since it has been held that where the general conditions of a claim are disclosed in the prior art (tinted portion), discovering the optimum or workable ranges (percent opacity) involves only routine skill in the art (In re Aller, 105 USPQ 233). Such a modification involves a mere change in opacity and thus would have required only routine skill in the art. Furthermore, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 125 USPQ 416).
Regarding claims 5, 12, and 15, Lundy discloses the second color of the packaging (liner 52) is a shade of white (bleached Kraft-Glassine paper – col 5, ln 20-21).
Regarding claims 6, 13, and 17, Lundy fails to disclose the transparent tinted portion has an opacity such that the first color is visually imperceptible on Fitzpatrick scale Type II skin. However, Lundy teaches the nasal dilator is substantially transparent, translucent, clear, a flesh-like color or shade so as to effectively blend with the skin of wearer (col 2, ln 25-30), and wherein the color can be selected to conform to a flesh color or tone (col 4, ln 21-24). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of LUNDY such that the transparent tinted portion has an opacity such that the first color is visually imperceptible on Fitzpatrick scale Type II skin, for the advantage of having a transparency level and color that renders the nasal dilator invisible on a common skin tone. Such a modification involves a mere change in opacity and color of the dilator and thus would have required only routine skill in the art. Furthermore, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 125 USPQ 416).
Regarding claim 20, as discussed above, Lundy teaches the base layer, cover layer, and resilient layer may be transparent (col 2, ln 24-28; col 8, ln 1-8) and at least one the base layer, cover layer, or resilient layer may form a tinted portion (col 2, ln 24-28). However, Lundy does not specifically teach only one of the base layer, cover layer, or resilient layer forms the tinted portion. However, since Lundy discloses any of the layers can comprise a flesh-like color or shade so as to effectively blend with the skin of the wearer and can be printed and/or tinted by any known process, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lundy such that the base layer, cover layer, and resilient layer are transparent and the transparent tinted portion forms part of only one of the base layer, cover layer, or resilient layer, for the advantage of improving the ability of the dilator to conform to a flesh color or tone (col 4, ln 21-24), as a person with ordinary skill has good reason to pursue the known options within his or her technical grasp and since it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success. Furthermore, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Ierulli US 2022/0347003, Ierulli US 2022/0347002, Ierulli US 2009/0234383, Muchin US 5,718,224, and Muchin US 5,611,334 each teach additional nasal dilators that may have transparent portions and/or portions tinted a flesh-like color or shade.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771