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 .
Applicant' s arguments, filed 7/26/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 7/26/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-2, 4-16, and 22-26 are the currently pending claims. Claim 4 has previously been withdrawn; Claims 3 and 17-21 have previously been canceled; claims 1, 5, 6, 9, 13, 16, and 24-26 have been amended; and claims 1, 2, 5-16, and 22-26 are under examination.
Claim Objections
Claim 5 is objected to because of the following informalities:
In claim 5, lines 6-7: “from each one of said different types of microporous film” lacks proper antecedent basis and is grammatically inconsistent because “said different types of microporous film” was not previously introduced and the singular “film” does not agree with the plural “types”; the intended referents appear to be the previously recited first and second sebum-absorbing hydrophobic microporous films, and the phrase should be corrected accordingly.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 25 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Claim 25 recites “when the device is held perpendicular to the gravity vector by one end, said body sags by no more than 10% as a result of gravity” in lines 2-3. The newly added limitation does not identify a reference dimension or other denominator for determining the recited “10%” sag. The body may have different shapes and dimensions within the scope of claim 1, and the claim does not identify whether the percentage is measured relative to a length, width, unsupported span, or another dimension of the body. The phrase “by one end” also does not identify which end or orientation is used where the body has more than one possible orientation. Because these alternatives can produce different determinations as to whether the same device satisfies the 10% limitation, the scope of claim 25 is not reasonably certain. The Instant Application at ¶[0178] repeats the same 10% sag language but does not provide a calculation, reference dimension, or test orientation that resolves these uncertainties. Accordingly, claim 25 is indefinite. Claim 25 is interpreted as requiring the vertical spacer to provide sufficient stiffness and self-support to the assembled device such that, when the device is held by one end in an orientation perpendicular to the gravity vector, gravity-induced sag of the body does not exceed 10%.
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.
Claims 1-2, 6-8, 11, 22-23, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Khazaka (US 5,935,521), hereinafter Khazaka, and further in view of Cantor et al. (US 2014/0243788 A1), hereinafter Cantor, and further in view of Miller (US 4,532,937), hereinafter Miller '937, and further in view of Bazin et al. (US 2002/0065452 A1), hereinafter Bazin.
Regarding claim 1, Khazaka teaches that a device suitable for characterizing skin (Khazaka, Abstract: "The invention concerns a measuring device for determining the secretion of the sebum from the skin using a microporous, water-repellent, sebum-absorbing opaque foil (4) which, on contact with the skin, can absorb sebum secreted by the surface of the skin, the transparency of the foil (4) being a measure of the absorbed sebum"; col. 2, ll. 28-35: "Such a film is therefore suitable for various tests with respect to the secretion of sebum from the skin", Khazaka teaches a skin-characterizing device that evaluates sebum-related skin condition based on the appearance change of a sebum-absorbing film) comprises a body having an upper surface and a lower contact face, configured to be contacted with a skin surface (Khazaka, Claim 1: "A device for collecting the secretion of sebum from the skin comprising a microporous hydrophobic sebum absorbing opaque film (4) having a first side adapted to be pressed against skin surface to absorb sebum and an opposite second side..."; col. 2, ll. 19-27: "the collecting means or measuring means for determining the secretion of sebum from the skin is multi-layered and comprises a sebum absorbing outer film 4 connected at two opposite edge portions 12 with a substrate film 6", Khazaka teaches a multilayer body having a skin-contacting side and an opposite side); said upper surface and said lower contact face both having an area of not less than 0.2 cm² and not more than 254 cm² (Khazaka is silent as to a specific area range; however, selection of the overall dimensions of a skin-applied device is a routine matter of design choice based on the intended skin coverage area, and a person of ordinary skill in the art would have found it obvious to size the device within the recited range for use on selected facial or body skin sites); said body having a thickness of not less than 30 micrometers and not more than 10 mm (Khazaka, col. 2, ll. 28-38: "The sebum absorbing film 4 consists, for example, of a microporous hydrophobic polypropylene film with a porosity between 20 and 50%, a thickness between 20 and 30 um and a pore size between 0.03 and 0.15 um"; Khazaka does not expressly teach the overall body thickness of the entire device. However, Khazaka teaches a multilayer construction in which the sebum-absorbing film (4) is connected to a substrate film (6) and may further include additional layers such as a protective film and adhesive-bearing structure (col. 2, ll. 19-27; col. 1, ll. 56-60). FIG. 3 further illustrates that the device comprises multiple stacked layers, including the microporous film (4) and surrounding supporting structure, such that the overall device thickness necessarily exceeds the thickness of the film alone. Given that Khazaka expressly teaches a film thickness of about 20-30 µm, the inclusion of additional structural layers would inherently result in an overall device thickness greater than 30 µm. Selection of an overall device thickness up to 10 mm would have been an obvious matter of routine design choice to provide sufficient structural integrity, handling, and conformity to the skin surface); further comprising a sebum indicator which changes appearance subsequent to absorbing sebum from skin (Khazaka, Abstract: "...using a microporous, water-repellent, sebum absorbing opaque foil (4) which, on contact with the skin, can absorb sebum secreted by the surface of the skin, the transparency of the foil (4) being a measure of the absorbed sebum"; col. 2, ll. 28-38: "Such a film has a uniform distribution of micropores and is opaque in its original state. Upon contact with sebum, the pores fill up, whereby the film becomes transparent at the corresponding places", Khazaka teaches a sebum indicator that changes appearance after absorbing sebum from skin); said sebum indicator comprising a first sebum-absorbing hydrophobic microporous polypropylene film on said lower contact face (Khazaka, col. 2, ll. 28-38: "The sebum absorbing film 4 consists, for example, of a microporous hydrophobic polypropylene film"; Claim 1: "a microporous hydrophobic sebum absorbing opaque film (4) having a first side adapted to be pressed against skin surface to absorb sebum", Khazaka expressly teaches a hydrophobic microporous polypropylene sebum-absorbing film at the skin-contact face); an average pore size between about 0.01 micrometers and about 0.1 micrometers (Khazaka, col. 2, ll. 28-38: "a pore size between 0.03 and 0.15 um"; Khazaka teaches a pore-size range that overlaps with the claimed range, at least between about 0.03 µm and 0.1 µm; selection of values within the overlapping range would have been obvious as a matter of routine optimization of a result-effective variable to control sebum absorption and pattern resolution); and a porosity of between about 30% and about 70% (Khazaka, col. 2, ll. 28-38: "a porosity between 20 and 50%", Khazaka teaches an overlapping porosity range).
Also regarding claim 1, the modified Khazaka does not expressly teach that at least a part of said contact face comprises an adhesive-bearing portion that surrounds a surface of said sebum indicator. Rather, Khazaka teaches a central sebum-indicating film region and a surrounding substrate/carrier arrangement associated with that film region. In particular, Khazaka teaches that "the collecting means or measuring means for determining the secretion of sebum from the skin is multi-layered and comprises a sebum absorbing outer film 4 connected at two opposite edge portions 12 with a substrate film 6 of a transparent rigid material" and further teaches that "[t]he substrate film 6 may also be cut out in its central part, the cut-out delimiting a defined measuring area on the film 4" (Khazaka, col. 2, ll. 19-27, 52-56). Khazaka also teaches that "[t]he adhesive area of the substrate film may be provided with a protective film" (Khazaka, col. 1, ll. 56-60). Thus, Khazaka teaches a sebum indicating region and a surrounding substrate structure associated with an adhesive area, but does not expressly teach that the adhesive-bearing portion of the contact face surrounds the surface of the sebum indicator.
Cantor teaches such a surrounding adhesive-bearing arrangement. In particular, Cantor teaches "a backing having a first major surface and a second major surface, and a skin-contact adhesive coupled to the second major surface of the backing" and further teaches "a portion of the backing and at least a portion of the skin-contact adhesive can extend beyond the skin treatment assembly in at least one direction to form an anchor" (Cantor, [0006]). Cantor further teaches that "the matrix 115 can be positioned next to, or within an area of the skin-contact adhesive 112... such that the matrix 115 and the skin-contact adhesive 112 do not substantially overlap" (Cantor, [0027]). Thus, Cantor teaches a central functional region on a contact-face side of a backing, with an adhesive-bearing portion extending beyond and surrounding that central region.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the modified Khazaka in view of Cantor so that at least a part of the contact face comprises an adhesive-bearing portion that surrounds a surface of the sebum indicator. The combination would have been possible because Khazaka teaches the central sebum indicating film region and surrounding substrate structure of the skin-contacting device, while Cantor teaches arranging a central functional region on an adhesive-bearing backing such that the adhesive-bearing portion extends beyond and surrounds that central region. A person of ordinary skill in the art would have been motivated to provide the Khazaka device with such a surrounding adhesive-bearing portion in order to secure the device on skin while maintaining the sebum indicating region exposed for skin contact and measurement. The combination would have been straightforward because it merely involves applying Cantor's known adhesive-bearing peripheral arrangement to Khazaka's known central sebum-indicating region in a skin-contacting device. The benefit of the combination would have been secure skin attachment while preserving the central sebum-indicating region for sebum measurement.
Also regarding claim 1, the modified Khazaka does not expressly teach that the first sebum-absorbing hydrophobic microporous film has a thickness of less than about 20 micrometers. Rather, the modified Khazaka teaches that the sebum absorbing film is "a microporous hydrophobic polypropylene film with a porosity between 20 and 50%, a thickness between 20 and 30 um and a pore size between 0.03 and 0.15 um" (Khazaka, col. 2, ll. 28-38). Thus, the modified Khazaka teaches the same type of hydrophobic microporous polypropylene sebum-indicating film, but does not expressly teach a thickness below about 20 micrometers.
Miller 937 teaches that the microporous hydrophobic polymeric film used for sebum collection may have "a film thickness of from about 0.01 mm to about 0.05 mm" and that "a CELGARD microporous polypropylene film that has a pore volume of about 40% and a thickness of about 0.01 to 0.03 mm has been found suitable" (Miller'937, col. 4, ll. 1-14). Miller 937 therefore teaches microporous polypropylene film thicknesses of about 10 to 50 micrometers, including film thicknesses less than about 20 micrometers.
It would have been prima facie obvious before the effective filing date of the claimed invention to further modify the modified Khazaka in view of Miller'937 by selecting the known microporous polypropylene sebum-indicating film thickness toward the thinner end of the ranges taught in the art, including less than about 20 micrometers. The combination would have been possible because both Khazaka and Miller 937 teach the same type of sebum-absorbing hydrophobic microporous polypropylene film used against the skin to generate a visible sebum pattern. A person of ordinary skill in the art would have been motivated to adopt the thinner microporous polypropylene film taught by Miller 937 in Khazaka's device in order to improve flexibility, skin conformity, and pattern definition while preserving the same sebum-indicating function. The benefit of the combination would have been improved resolution and responsiveness of the sebum-indicating film while maintaining compatibility with Khazaka's supported multilayer construction.
Also regarding claim 1, the modified Khazaka does not expressly teach an air permeability of between about 50 Gurley seconds and about 1000 Gurley seconds. Rather, the modified Khazaka teaches a microporous hydrophobic polypropylene film for sebum collection and pattern formation, and teaches structural film properties including pore size, porosity, and thickness. Where Khazaka teaches a porosity between 20 and 50%, a thickness between 20 and 30 um, and a pore size between 0.03 and 0.15 um (Khazaka, col. 2, ll. 28-38) and Miller'937 likewise teaches that microporous films suitable for sebum collection have "a pore volume of from about 25% to about 50%, a film thickness of from about 0.01 mm to about 0.05 mm" and that "the effective pore diameters should be less than about 0.1 micron" (Miller'937, col. 4, ll. 1-34). Thus, the modified Khazaka teaches the structural properties that govern permeability, but does not specify Gurley air permeability.
It would have been prima facie obvious before the effective filing date of the claimed invention to select or adjust structural parameters that inherently yield an air permeability within a workable range, including the claimed range of about 50 Gurley seconds to about 1000 Gurley seconds, as a result-effective variable. Gurley air permeability is a known parameter inherently determined by, and directly correlated with, film thickness, porosity, and pore size in microporous films of the type expressly taught by Khazaka and Miller 937. Because the modified Khazaka already teaches these underlying structural variables, a person of ordinary skill in the art would have understood that selecting or slightly adjusting those variables would necessarily result in a corresponding and predictable air permeability. A person of ordinary skill in the art would have been motivated to select values that provide sufficient sebum migration into the pores without excessive lateral spreading, thereby achieving a usable and interpretable sebum-absorption pattern. The benefit of such selection would have been predictable control over flow resistance through the film, enabling reliable sebum transfer while maintaining pattern resolution for skin characterization.
Also regarding claim 1, the modified Khazaka does not fully teach that the first sebum-absorbing hydrophobic microporous film is thereby configured to provide a fine sebum-absorption pattern, suitable for providing information regarding a number, size and size distribution of skin pores and a presence of fine wrinkles. Rather, the modified Khazaka teaches that the microporous hydrophobic film produces a spatially resolved sebum-absorption pattern, stating that "Such a film has a uniform distribution of micropores and is opaque in its original state. Upon contact with sebum, the pores fill up, whereby the film becomes transparent at the corresponding places" (Khazaka, col. 2, ll. 28-38). Thus, it teaches that sebum absorption produces localized transparent regions corresponding to sites of sebum secretion on the skin, thereby providing a pattern that reflects the spatial distribution of sebum-secreting pores. It also teaches that the transparency of the foil is a measure of absorbed sebum and that the film is suitable for "various tests with respect to the secretion of sebum from the skin" (Khazaka, Abstract; col. 2, ll. 28-38). However, the modified Khazaka does not expressly disclose evaluating that pattern in terms of the number, size, and size distribution of pores or assessing wrinkle-related skin features.
Miller'937 teaches analyzing the sebum-derived pattern to extract quantitative pore information, including "comparing the number and size of translucent areas on the test sample with those on preselected standards" and observing "the number and size of the cleared areas (each of which occurs precisely over an actively excreting sebaceous gland)" (Miller 937, col. 3, ll. 21-24; col. 5, ll. 62-66). Thus, Miller '937 teaches that a microporous sebum-absorbing film produces a pattern that can be evaluated to determine the number and size of pores and their distribution across the skin surface, but does not expressly disclose assessing wrinkle-related skin features from that pattern.
Bazin teaches that wrinkle-related skin characteristics may be evaluated from a skin-contact-derived image or transfer member using image analysis. Bazin teaches that "a transfer member is placed in contact with the external portion of the individual to provide an image on the transfer member" (Bazin, [0018]), and that such transfer members may include adhesive material placed in contact with skin and removed to transfer material (Bazin, [0019]). Bazin further teaches that characteristics of the external portion include "wrinkles, crows eyes" (Bazin, [0012]), and that analysis of such characteristics is conducted based on the scanned image data (Bazin, [0011]).
It would have been prima facie obvious before the effective filing date of the claimed invention to use the fine sebum absorption pattern produced by the modified Khazaka in view of Miller 937 and Bazin to provide information regarding the number, size and size distribution of skin pores and a presence of fine wrinkles. The combination would have been possible because Khazaka and Miller'937 each teach the same general type of skin-contacting microporous hydrophobic sebum-absorbing film that produces localized transparent regions at skin sites of sebum secretion, and Miller 937 expressly teaches analyzing that resulting pattern by evaluating the number and size of the translucent or cleared areas corresponding to sebaceous gland locations. Thus, Miller'937 provides a directly compatible manner of analyzing the same type of film-derived pattern already produced by Khazaka, without requiring a change in the basic operating principle of Khazaka's device. The output of Khazaka's device is a visible pattern of localized transparent regions on a film surface, which is the same type of observable pattern produced and analyzed in Miller'937, and is likewise a surface pattern suitable for image-based evaluation as taught by Bazin. Thus, no structural modification of the Khazaka device is required, and the combination merely involves applying known analysis techniques to the pattern already produced by Khazaka. Bazin further teaches that a skin-contact-derived surface pattern or image may be subjected to image analysis to evaluate wrinkles and related skin features. A person of ordinary skill in the art would have been motivated to apply Miller'937's quantitative pore-pattern analysis and Bazin's wrinkle-analysis techniques to the localized transparent pattern already generated by Khazaka in order to extract additional skin-surface information from the same sampling event. The benefit of the combination would have been the ability to obtain pore related and wrinkle-related information from a single sebum-derived skin-contact pattern, thereby improving the overall diagnostic utility of the device.
Regarding claim 2, the modified Khazaka does not expressly teach that said sebum indicator makes up between about 5% and about 50% of a surface area of said contact face. Rather, the modified Khazaka teaches a device in which the sebum-absorbing film occupies a defined measuring area within a larger skin-contacting structure. In particular, it teaches that "the collecting means or measuring means for determining the secretion of sebum from the skin is multi-layered and comprises a sebum absorbing outer film 4 connected at two opposite edge portions 12 with a substrate film 6" and that "[t]he substrate film 6 may also be cut out in its central part, the cut-out delimiting a defined measuring area on the film 4" (Khazaka, col. 2, ll. 19-51). FIG. 4 further illustrates that the sebum-absorbing film (4) occupies only a central portion of the contact face and is surrounded by additional structure. Thus, it teaches that the sebum indicator occupies only a defined portion of the overall contact face rather than the entirety of that face. However, the modified Khazaka does not expressly disclose that this portion is between about 5% and about 50% of the surface area of the contact face.
It would have been prima facie obvious before the effective filing date of the claimed invention to select the sebum-indicating area of the modified Khazaka such that it makes up between about 5% and about 50% of the surface area of the contact face, as a matter of routine optimization of a known dimensional relationship. The modified Khazaka already teaches the relevant structure, namely, a defined active measuring region within a larger contact-face structure. A person of ordinary skill in the art would have understood that the relative area occupied by the sebum indicator could be selected according to the desired balance between active sampling area and the surrounding structure used for support, handling, adhesion, and positioning on the skin, while preserving the same operating principle of sebum absorption and pattern formation. A person of ordinary skill in the art would therefore have been motivated to select a sebum-indicator area within the claimed range in order to provide sufficient active area for meaningful sebum-pattern evaluation while retaining sufficient surrounding area for structural support and practical skin application. The benefit would have been a device having a practical balance between measurement area and surrounding support structure, thereby improving usability and consistent skin contact during measurement.
Regarding claim 6, the modified Khazaka does not expressly teach that said sebum indicator comprises a microporous film assembly comprising said first sebum-absorbing hydrophobic microporous polypropylene film and a planar vertical spacer having a front side and a back side, wherein said first sebum-absorbing hydrophobic microporous polypropylene film is attached to said front side of said vertical spacer; and wherein said microporous film assembly is attached to other components of the device through said back side of said vertical spacer. Rather, the modified Khazaka teaches a microporous-film assembly in which the first sebum-absorbing hydrophobic microporous polypropylene film is supported and mounted at its edge region by a surrounding planar structural member located on the side of the film averted from the skin. In particular, Khazaka teaches that "the sebum absorbing film is connected to a substrate in the edge portion, the substrate being cut out or transparent in the area of the film to be brought into contact with the skin surface" and that "[t]he substrate may be made of a transparent rigid substrate film connected in the edge portion with the sebum absorbing film on the side of the film averted from the skin surface" (Khazaka, col. 1, ll. 30-50). Khazaka further teaches that "[t]he substrate may be annular in shape" and that "the substrate may be made of two rings clamping the sebum absorbing film between them" (Khazaka, col. 1, ll. 30-50). Khazaka also teaches that "FIG. 3 illustrates a second embodiment, wherein the sebum absorbing film 4 is tightened between two rings or frame portions 18, 20", and that such rings "may also be adhered onto a support frame 22, using an adhesive layer in the side of the ring 18 averted from the film 4" (Khazaka, col. 2, ll. 57-65; FIG. 3). Thus, the modified Khazaka teaches a film assembly in which the first sebum-absorbing hydrophobic microporous polypropylene film is attached at the edge to a distinct surrounding planar support member on one side of that member, while that member is attached to further device structure from the opposite side, including by adhesive on the side averted from the film. The annular ring or frame portions of Khazaka therefore already define a spacer-like member having opposite sides and a thickness dimension between those sides, even though Khazaka does not expressly name that member a "vertical spacer."
It would have been prima facie obvious before the effective filing date of the claimed invention to implement or characterize the annular substrate or frame portions of the modified Khazaka as a planar vertical spacer having a front side and a back side, with the first sebum-absorbing hydrophobic microporous polypropylene film attached at the front side and the assembly attached to other components of the device through the back side, because the modified Khazaka already teaches that same basic structural relationship. The combination would have been possible because Khazaka already teaches a surrounding annular or frame-like member that supports and tensions the microporous film at its edge, positions the film at the contact face, and is adhered to further device structure from the side opposite the film. A person of ordinary skill in the art would have understood that such a planar annular support member inherently functions as a spacer between the film and the remainder of the device, with one side carrying the film and the opposite side serving as the mounting side for attachment to other components, including by adhesive. A person of ordinary skill in the art would have been motivated to do so in order to provide a compact planar mounting structure that maintains the film taut and facilitates secure assembly to the remainder of the device. The benefit would have been improved structural support and ease of assembly while maintaining accurate presentation of the microporous film at the skin-contact face.
Regarding claim 7, the modified Khazaka does not expressly teach that the device comprises an adhesive layer which constitutes said adhesive-bearing portion of said contact face and which also contacts said back side of said vertical spacer so as to maintain at least said first microporous film on said contact face. Rather, the modified Khazaka teaches that the microporous film assembly is mounted by adhesive on the side of the surrounding support member opposite the film. In particular, Khazaka teaches that "FIG. 3 illustrates a second embodiment, wherein the sebum absorbing film 4 is tightened between two rings or frame portions 18, 20" and that such rings "may also be adhered onto a support frame 22, using an adhesive layer in the side of the ring 18 averted from the film 4" (Khazaka, col. 2, ll. 57-65; FIG. 3). Khazaka further teaches that "the adhesive area of the substrate film may be provided with a protective film... whereby the adhesive area is protected prior to use" (Khazaka, col. 1, ll. 57-64). Thus, the modified Khazaka teaches both an adhesive-bearing structure associated with the contact face of the device and adhesive contact with the side of the ring or frame member opposite the film, thereby securing the surrounding spacer-like member and maintaining the microporous film assembly in position at the contact face. However, Khazaka does not expressly state that the same adhesive layer both constitutes the adhesive-bearing portion of the contact face and contacts the back side of the vertical spacer.
It would have been prima facie obvious before the effective filing date of the claimed invention to implement the adhesive layer of the modified Khazaka such that the adhesive layer constitutes the adhesive-bearing portion of the contact face and also contacts the back side of the vertical spacer so as to maintain at least the first microporous film on the contact face, because the modified Khazaka already teaches both the relevant adhesive-bearing structure and the relevant back-side adhesive contact with the surrounding spacer-like member. The combination would have been possible because Khazaka already teaches an adhesive area associated with the substrate film and also teaches that the ring or frame portion surrounding the film may be adhered to further support structure from the side averted from the film. A person of ordinary skill in the art would have understood from Khazaka that adhesive is used both to secure the device to the skin and to secure structural components of the device, including the ring or frame supporting the microporous film. Because Khazaka does not require separate adhesive systems for these functions, a person of ordinary skill in the art would have recognized that a single adhesive layer could be arranged to both provide skin adhesion at the contact face and contact the back side of the surrounding spacer-like member to maintain the microporous film assembly in position. Such an arrangement would represent a predictable simplification of the adhesive structure while preserving the same functional relationships taught by Khazaka. A person of ordinary skill in the art would have been motivated to do so in order to reduce manufacturing complexity and improve structural integration of the device. The benefit would have been a more efficient adhesive configuration that both secures the device to the skin and maintains the film assembly in proper position.
Regarding claim 8, the modified Khazaka does not expressly teach that said vertical spacer has a thickness of between about 50 micrometers and about 250 micrometers. Rather, the modified Khazaka teaches a surrounding annular or frame-like spacer member that supports the microporous film and attaches the film assembly to further device structure. In particular, Khazaka teaches that "[t]he substrate may be annular in shape" and that "the substrate may be made of two rings clamping the sebum absorbing film between them" (Khazaka, col. 1, ll. 43-46). Khazaka also teaches that "FIG. 3 illustrates a second embodiment, wherein the sebum absorbing film 4 is tightened between two rings or frame portions 18, 20," and that such rings "may also be adhered onto a support frame 22, using an adhesive layer in the side of the ring 18 averted from the film 4" (Khazaka, col. 2, ll. 57-65; FIG. 3). Thus, the modified Khazaka teaches a ring or frame member functioning as the spacer structure of the film assembly and necessarily having a thickness dimension extending between its opposite sides. However, Khazaka does not expressly disclose that this thickness is between about 50 micrometers and about 250 micrometers.
It would have been prima facie obvious before the effective filing date of the claimed invention to select the thickness of the spacer-like ring or frame member of the modified Khazaka to be between about 50 micrometers and about 250 micrometers, as a matter of routine optimization of a known dimensional characteristic of that spacer structure. The combination would have been possible because the modified Khazaka already teaches that the ring or frame member supports and tensions the microporous film and provides the mounting structure by which the film assembly is attached to further device components. A person of ordinary skill in the art would have understood that the thickness of that spacer-like member would be selected to balance competing design considerations including sufficient rigidity to support and maintain the film, sufficient spacing and edge support for the film assembly, and a sufficiently thin profile for practical placement on the skin. A person of ordinary skill in the art would therefore have been motivated to select a thickness within the claimed range in order to provide adequate structural support and manufacturability while maintaining a thin, compact skin-contacting device. The benefit would have been a practical balance between support, ease of assembly, and low-profile skin contact.
Regarding claim 11, the modified Khazaka does not expressly teach that said upper surface of said body comprising at least one image-correction feature that assists in computerized correction of the color and/or white balance of an acquired image in which said upper surface appears. Rather, the modified Khazaka teaches a skin-characterizing device whose results are visually observed based on changes in appearance of the sebum-absorbing film, but does not expressly disclose providing an image-correction feature on the upper surface of the device for use in computerized correction of color and/or white balance of an acquired image.
Bazin teaches the use of a calibration feature within an acquired image to permit computerized correction and calibration of image characteristics. In particular, Bazin teaches that "a calibration member is scanned along with the external portion and/or the image of the transfer member. The calibration member preferably has a predetermined size and/or a predetermined color" (Bazin, ¶[0039]). Bazin further teaches that "the calibration member could have a predetermined size and or color that would enable calibration of an image formed from the scanned image data (for example, via image processing software such as Photoshop) to provide a more exact indication of the size and/or color of characteristics" (Bazin, ¶[0099]). Thus, Bazin teaches that including a known visual reference feature within an acquired image assists computerized correction and calibration of image characteristics, including color-related characteristics.
It would have been prima facie obvious before the effective filing date of the claimed invention to provide the upper surface of the modified Khazaka with at least one image correction feature that assists in computerized correction of the color and/or white balance of an acquired image in which the upper surface appears, in view of Bazin. The combination would have been possible because the modified Khazaka already teaches a device whose usefulness depends on visual interpretation of appearance-based information, and Bazin teaches that a calibration member having a predetermined size and/or predetermined color may be scanned with the subject being analyzed so that the resulting image can be calibrated by image processing software to provide a more exact indication of characteristics, including color characteristics. A person of ordinary skill in the art would have understood that correcting image color using a reference feature as taught by Bazin inherently includes correcting white balance, since white balance is a form of color calibration used to normalize color representation under varying illumination conditions. A person of ordinary skill in the art would have been motivated to do so in order to improve consistency and accuracy of image-based evaluation of the device results under different lighting conditions and camera settings. The benefit of the combination would have been more reliable computerized interpretation of the device image through improved correction of color and/or white balance.
Regarding claim 22, the modified Khazaka does not expressly teach that said adhesive-bearing portion is configured for assisting in maintaining said sebum indicator in contact with a skin surface. Rather, Khazaka teaches a sebum-indicating assembly for application to skin, including a microporous sebum-absorbing film mounted to a supporting structure and pressed against the skin surface for measurement. However, it does not expressly teach an adhesive-bearing portion configured to assist in maintaining contact with the skin.
Cantor, already incorporated into the modified Khazaka, teaches such an adhesive-bearing portion configured to maintain contact with the skin. In particular, Cantor teaches "a backing having a first major surface and a second major surface, and a skin-contact adhesive coupled to the second major surface of the backing" (Cantor, ¶[0006]) and further teaches that "the patch 102 can include a backing 110, and an adhesive 112... the skin-contact adhesive 112 can be coupled ... to the second major surface 116" (Cantor, ¶[0026]). Thus, Cantor teaches that the adhesive-bearing portion is configured to maintain the skin-contacting device, and therefore the attached central functional region, in contact with the skin surface.
It would have been prima facie obvious before the effective filing date of the claimed invention to utilize the adhesive-bearing portion of the modified Khazaka, as already provided by Cantor, as configured for assisting in maintaining the sebum indicator in contact with a skin surface. The combination would have been possible because Khazaka teaches a sebum-indicating assembly for placement on skin, while Cantor teaches an adhesive-bearing supporting sheet used to maintain a skin-contacting device in contact with the skin. A person of ordinary skill in the art would have been motivated to incorporate the adhesive-bearing structure of Cantor into Khazaka in order to maintain consistent and stable contact between the sebum-indicating assembly and the skin surface during use. The combination would have been straightforward because it merely involves applying a known adhesive retention feature to a known skin-contacting device for the same purpose. The benefit of the combination would have been improved stability and reliability of the sebum measurement by maintaining consistent contact with the skin during use.
Regarding claim 23, Khazaka teaches that said adhesive-bearing portion is configured for maintaining a protective cover attached to said lower contact face prior to use of the device (Khazaka, col. 1, ll. 57-60: "[t]he adhesive area of the substrate film may be provided with a protective film... whereby the adhesive area is protected prior to use"; explains that the adhesive-bearing portion includes a protective film covering the adhesive area prior to use; col. 2, ll. 19-27: "a protective film 14 with an adhesive layer 10... is arranged on the side of the substrate film 6 averted from the film 4"; further shows that the protective film is maintained on the adhesive-bearing portion prior to use, thereby maintaining a protective cover attached to the lower contact face).
Regarding claim 25, the modified Khazaka as set forth in the rejection of claim 6 above teaches that said vertical spacer is stiff and self-supporting (Khazaka, col. 2, ll. 57-65: "FIG. 3 illustrates a second embodiment, wherein the sebum absorbing film 4 is tightened between two rings or frame portions 18, 20. Such rings keep the sebum absorbing film 4 tight", which shows that the ring/frame spacer has sufficient rigidity to maintain its structure and support the attached film, and thus, under the Examiner's interpretation, teaches that the vertical spacer is stiff and self-supporting).
Also regarding claim 25, the modified Khazaka does not expressly teach that when the device is held perpendicular to the gravity vector by one end, said body sags by no more than 10% as a result of gravity. Rather, Khazaka teaches that its supporting structure maintains the sebum-absorbing film substantially tight and planar, including so that the film can be pressed against the skin without kinking and can be held tightly for evaluation without measurement errors resulting from loss of planarity, but does not expressly quantify the gravity-induced sag of the body as no more than 10% (Khazaka, col. 1, ll. 18-22, 33-43; claims 1, 5).
It would have been prima facie obvious before the effective filing date of the claimed invention to have selected the rigidity of the spacer-like supporting structure of the modified Khazaka such that the assembled device satisfies the recited no-more-than-10% gravity-induced sag condition. Khazaka expressly identifies maintaining the sebum-absorbing film substantially tight and planar, preventing kinking, and avoiding measurement errors resulting from deformation of the film as objectives of its supporting structure (Khazaka, col. 1, ll. 18-22, 33-43; claims 1, 5). A person of ordinary skill therefore would have been motivated to provide sufficient rigidity to the spacer-like supporting structure to limit deformation of the body that would interfere with those stated objectives. The rigidity of the supporting structure could have been adjusted through ordinary selection of its material, thickness, and structural dimensions without changing the sebum-collection operation of the device. Selecting sufficient rigidity to satisfy the recited sag criterion would have constituted routine optimization of the known mechanical support characteristic for Khazaka's stated purposes of maintaining the film substantially tight and planar, preventing kinking, and preserving accurate evaluation.
Regarding claim 26, the modified Khazaka does not expressly teach that said microporous film is attached to said front side of said vertical spacer using an adhesive that is devoid of a material that can leach into said microporous film under normal storage or use conditions of the device. Rather, the modified Khazaka teaches a microporous film and a spacer/frame structure in which the film is retained between rings or frame portions (mechanical retention), but does not expressly teach attaching the microporous film to the front side of the vertical spacer using an adhesive having the presently recited non-leaching characteristic under normal storage or use conditions.
Miller '937 teaches coating a microporous film with an adhesive and further teaches that the adhesive should be non-leaching, thereby forming an adhesive-coated film suitable for attachment to another structure. In particular, Miller '937 teaches that "[w]hile many commercially available pressure-sensitive adhesives can be used to coat the microporous film, it is important that they be virtually without low molecular weight components so as to minimize the possibility of the adhesive migrating into the pores of the microporous film during storage" (Miller '937, col. 4, ll. 14-34). Miller '937 further teaches that "[r]ubber based adhesives and other adhesives containing low molecular weight portions should be avoided as they tend to migrate into the micropores of the film" (Miller '937, col. 4, ll. 14-34). Thus, Miller '937 teaches an adhesive-coated microporous film and teaches using an adhesive devoid of components that can leach or migrate into the microporous film, including during storage of the device, which is suitable for bonding the film to a support. Miller '937 also claims an adhesive consisting essentially of high molecular weight components that are resistant to migration into the pores of the microporous film (Miller '937, claims 1, 15).
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Khazaka in view of Miller '937 to have the microporous film attached to the front side of the vertical spacer using an adhesive devoid of material that can leach into the microporous film under normal storage or use conditions of the device. The combination would have been possible because Khazaka teaches a microporous film and spacer/frame arrangement, while Miller '937 teaches using adhesive with a microporous film and teaches selecting that adhesive to avoid migration into the micropores, including expressly during storage. A person of ordinary skill in the art would have been motivated to use such an adhesive in order to attach the microporous film while preventing interference with the microporous film's sebum-absorbing properties and preserving accurate pattern formation, and would have further understood that the microporous film retained between the rings of Khazaka could be secured by, or in combination with, an adhesive, as adhesives are a known equivalent means of securing films to supporting structures, particularly where uniform attachment and reduced mechanical complexity are desired. The combination would have been straightforward because it merely involves using the known adhesive-coated microporous film approach of Miller '937 with the known microporous film and spacer arrangement of Khazaka. The benefit of the combination would have been secure attachment of the microporous film to the spacer while preserving the functional integrity of the microporous film during storage and use.
Claims 5 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Khazaka (US 5,935,521), hereinafter Khazaka, and further in view of Cantor et al. (US 2014/0243788 A1), hereinafter Cantor, and further in view of Miller (US 4,532,937), hereinafter Miller '937, and further in view of Bazin et al. (US 2002/0065452 A1), hereinafter Bazin, and further in view of Kawam (US 5,094,248), hereinafter Kawam.
The modified Khazaka teaches claim 1 as described above.
Regarding claim 5, the modified Khazaka does not expressly teach that said sebum indicator further comprises at least a second sebum-absorbing hydrophobic microporous film on said contact face, said first sebum-absorbing hydrophobic microporous film and said second sebum-absorbing hydrophobic microporous film having different sebum-absorbing properties so as to provide substantially different patterns of sebum absorption when contacted with a skin surface. Rather, the modified Khazaka teaches a plurality of film-based sebum-measuring means on the same device. Khazaka teaches that "FIG. 2 illustrates a test strip 8 with a plurality of measuring means for determining the secretion of sebum from the skin" and further teaches that "[t]he measuring means are prepared for removal by providing a punch cut in a correspondingly layered strip material and may easily be taken from the test strip 8" (Khazaka, col. 2, ll. 52-56). FIG. 2 likewise illustrates a single test strip carrying multiple measuring means. Khazaka further teaches that the measuring means for determining the secretion of sebum from the skin are multi-layered and comprise "a sebum absorbing outer film 4" (Khazaka, col. 2, ll. 19-27). Khazaka also teaches that the sebum-absorbing film may be selected with different physical characteristics, stating that "[t]he sebum absorbing film 4 consists, for example, of a microporous hydrophobic polypropylene film with a porosity between 20 and 50%, a thickness between 20 and 30 um and a pore size between 0.03 and 0.15 um" (Khazaka, col. 2, ll. 28-38). Thus, Khazaka teaches a single skin-contacting strip having a plurality of layered sebum-measuring means, each including a sebum-absorbing microporous film, and further teaches relevant physical film properties for such a film. However, the modified Khazaka does not expressly disclose that first and second such films have different sebum-absorbing properties so as to provide substantially different sebum-absorption patterns.
Kawam teaches that changing physical properties of the film changes its absorption and response behavior. In particular, Kawam teaches that "The type of polymer, and the polarity of the film are not the only factor affecting the rate of pore filling. Film thickness is another property that affects the rate at which the pores are filled to produce the transparency change" and further teaches that "A porosity range of 30-60% is suited" and that "[a]n effective pore size range of 0.01 to 0.05 is acceptable" (Kawam, col. 5, ll. 17-29). Thus, Kawam expressly teaches that physical properties of the film, including polymer type, polarity, thickness, porosity, and pore size, affect the rate of pore filling and the resulting transparency response of the film, i.e., its sebum-absorbing and pattern-forming behavior.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Khazaka such that the plurality of Khazaka measuring means on the same test strip included first and second sebum-absorbing hydrophobic microporous films having different sebum-absorbing properties, in view of Kawam. The combination would have been possible because the modified Khazaka already teaches a single test strip carrying a plurality of layered sebum-measuring means including sebum-absorbing microporous film, and further teaches relevant physical film properties for that film, while Kawam expressly teaches that changes in film properties affect the rate of pore filling and the resulting transparency response. A person of ordinary skill in the art would have understood from Kawam that varying the film properties already taught by the modified Khazaka among different ones of Khazaka's multiple measuring means would predictably vary their sebum-absorbing behavior and resulting visible sebum patterns, while preserving the same basic skin-contacting sebum-sampling operation of the strip. A person of ordinary skill in the art would have been motivated to do so in order to obtain substantially different sebum-absorption patterns from the same test strip and thereby provide different types or levels of sebum-characterization information from a single application of the device to the skin. The benefit of the combination would have been improved diagnostic utility through side-by-side comparison of different sebum responses on one strip.
Also, regarding claim 5, the modified Khazaka does not expressly teach thereby allowing the device to provide different types of information about the skin from each one of said different types of microporous film. Rather, as established regarding claim 1, the first sebum-absorbing hydrophobic microporous film provides information concerning skin pores and fine wrinkles, and the modification above provides a second hydrophobic microporous film having different sebum-absorbing properties and a correspondingly different visible sebum-absorption pattern. However, the modified Khazaka does not expressly teach using the respective different patterns to obtain different types of skin-characterization information from the respective films.
Kawam teaches that a pattern produced by a microporous hydrophobic sebum-absorbing film can provide a different type of skin-characterization information, namely skin oiliness. Kawam explains that the sebum-filled pores of such a film appear as black-dot patterns and that comparison with a precalibrated reference pattern "allows definition of the type of skin (i.e. the amount of sebum generated)" (Kawam, Fig. 1; col. 3, ll. 46-51). Thus, Kawam teaches using a sebum-absorption pattern from a microporous film to provide qualitative information concerning skin oiliness.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Khazaka by using the different sebum-absorption pattern produced by the second film for skin-oiliness characterization as taught by Kawam. The modification would have used the same visible transparency response already produced by the second sebum-absorbing film and therefore would not have changed its skin-contacting or sebum-absorbing operation. A person of ordinary skill in the art would have been motivated to use the second film's different response for skin-oiliness characterization because Kawam teaches that comparison of the resulting sebum pattern with reference patterns permits determination of skin type based on the amount of sebum generated. In the resulting device, the first film provides the pore and wrinkle-related information established regarding claim 1, while the second film provides skin-oiliness information, thereby providing different types of information about the skin from the respective microporous films.
Regarding claim 24, the modified Khazaka as set forth in the rejections of claims 1 and 5 above teaches that said second sebum-absorbing hydrophobic microporous film comprises polypropylene and has different sebum-absorbing properties so as to provide substantially different patterns of sebum absorption when contacted with a skin surface (Khazaka, col. 2, ll. 28-38: "a microporous hydrophobic polypropylene film with a porosity between 20 and 50%, a thickness between 20 and 30 um and a pore size between 0.03 and 0.15 um"; teaches a microporous hydrophobic polypropylene film; claim 5 rejection above explains that the modified Khazaka teaches first and second microporous hydrophobic films having different sebum-absorbing properties so as to provide substantially different patterns of sebum absorption).
Also regarding claim 24, the modified Khazaka does not fully teach that said second sebum-absorbing hydrophobic microporous film has a porosity of between about 30% and about 70%, an air permeability of between about 50 Gurley seconds and about 1000 Gurley seconds, and a thickness of greater than about 25 micrometers, thereby configured to provide a qualitative characterization of an oiliness of the skin. Rather, the modified Khazaka, as set forth in the rejections of claims 1 and 5 above, teaches microporous hydrophobic polypropylene film structural properties including overlapping porosity and air-permeability-related characteristics for sebum-absorbing films, and further teaches a second sebum-absorbing hydrophobic microporous film having different sebum-absorbing properties so as to provide substantially different patterns of sebum absorption. However, the modified Khazaka does not expressly teach selecting the second film to have a thickness greater than about 25 micrometers while possessing the recited structural parameters and using the resulting sebum response to provide a qualitative characterization of skin oiliness.
Miller '937 teaches such a thicker microporous hydrophobic polypropylene film. In particular, Miller '937 teaches that "a CELGARD microporous polypropylene film that has a pore volume of about 40% and a thickness of about 0.01 to 0.03 mm has been found suitable" and further teaches that suitable films generally have "a pore volume of from about 25% to about 50% and a film thickness of from about 0.01 mm to about 0.05 mm" (Miller '937, col. 4, ll. 1-34). Miller '937 further claims microporous polypropylene as the film material. Thus, Miller '937 teaches a microporous hydrophobic polypropylene film having porosity overlapping the claimed range and thicknesses including greater than about 25 micrometers.
Kawam teaches that film thickness is a property affecting the sebum-induced response of the microporous film. Kawam states that "Film thickness is another property that affects the rate at which the pores are filled to produce the transparency change", teaches that "[a] thickness range of 0.01 mm to 0.05 mm is acceptable with 0.025 mm (1 mil) being preferred", and teaches that "[a] porosity range of 30-60% is suited" (Kawam, col. 5, ll. 17-29). Kawam further teaches classifying the resulting sebum response according to skin oiliness, including reference scales of Dry, Dry/Normal, Normal, Normal/Oily, and Oily, and teaches reference dot patterns for assessing one's skin oiliness condition (Kawam, col. 5, ll. 57-68; col. 6, ll. 1-13; col. 7, ll. 1-9, 17-28).
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Khazaka in view of Miller '937 and Kawam by selecting for the second sebum-absorbing hydrophobic microporous polypropylene film a thickness greater than about 25 micrometers within the expressly taught suitable thickness range. The combination would have been possible because Miller '937 teaches the same type of microporous hydrophobic polypropylene film used for sebum collection and expressly identifies suitable porosity and thickness ranges encompassing the claimed values, while Kawam teaches that film thickness is a known property affecting the rate of pore filling and resulting transparency response. A person of ordinary skill in the art would have been motivated to select a thickness greater than about 25 micrometers for the second film from the disclosed suitable range in order to provide a sebum response different from that of the thinner first film, consistent with Kawam's teaching that film thickness affects the film response, and to use the resulting sebum pattern for qualitative characterization of skin oiliness as taught by Kawam. The modification would have constituted selection of a known value of a recognized result-effective variable within the disclosed suitable range and use of the resulting sebum response for its known skin-oiliness characterization purpose. The resulting second film would have the recited polypropylene, porosity, air-permeability, and greater-than-about-25-micrometer thickness characteristics and would provide a qualitative characterization of skin oiliness.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Khazaka (US 5,935,521), hereinafter Khazaka, and further in view of Cantor et al. (US 2014/0243788 A1), hereinafter Cantor, and further in view of Miller (US 4,532,937), hereinafter Miller '937, and further in view of Bazin et al. (US 2002/0065452 A1), hereinafter Bazin, and further in view of Brehm et al. (US 5,433,214), hereinafter Brehm, and further in view of Gueret (FR 2,774,287 A1), hereinafter Gueret, and further in view of Miller (US 5,088,502), hereinafter Miller '502, and further in view of Kosugi et al. (WO 2021/166354 A1), hereinafter Kosugi.
The modified Khazaka teaches claim 1 as described above.
Regarding claim 9, the modified Khazaka does not expressly teach that said adhesive-bearing portion of said contact face includes at least two differently-colored parts when viewed from perpendicular towards said contact face, including a dark-colored part of said contact face and a light-colored part of said contact face. Rather, the modified Khazaka teaches an adhesive-bearing skin-contacting device having a sebum-indicating region and surrounding support structure, but does not expressly disclose differently-colored portions of the adhesive-bearing contact face.
Brehm teaches a skin-contacting indicator using a visually contrasting indicator structure. In particular, Brehm teaches "an indicator for determining and indicating the fat and moisture content of human skin" including "a substrate being colored other than white; and approximately white-tinted, fat-sensitive and moisture-sensitive, highly porous silicon dioxide applied to said substrate", wherein the substance changes appearance as a function of the fat and moisture content of the skin so that "the colored substrate underneath said silicon dioxide shows through at least partially and becomes visible" (Brehm, Claim 1). Thus, Brehm teaches a skin-contacting portion having a visually distinguishable appearance.
Gueret teaches a skin-contacting adhesive patch and further teaches the use of color for visual evaluation of material extracted from the skin. In particular, Gueret teaches that "[t]his application relates to a patch suitable for removing impurities from the skin" and that the invention proposes "a patch suitable for removing impurities from the skin, comprising on a support, a polymeric matrix containing at least one active ingredient, the surface of the patch intended to be... placed in contact with the skin being adhesive, characterized in that it comprises a colored layer so as to be able, visually, to quantify and/or qualify the impurities extracted from the skin, and present on said adhesive surface" (Gueret, ¶[0007], [0012]). Gueret further teaches that "[a]dvantageously, the colored layer is dark in color, so as to achieve sufficient contrast to highlight the impurities extracted from the skin, which are generally light in color" (Gueret, ¶[0012]). Thus, Gueret teaches an adhesive skin-contacting portion using color contrast for visual observation of extracted material.
Miller '502 teaches that dark-colored and light or clear regions may be selected to provide contrast and facilitate visualization on a skin-contacting adhesive device. In particular, Miller '502 teaches "a dark colored light absorbing area printed on said substrate" with "a layer of adhesive disposed on said substrate and overlaying said light absorbing area" (Miller '502, Claim 1), and also notes prior use of adhesive tape "with either a black background or clear or translucent background" for skin-surface sampling (Miller '502, col. 1, ll. 19-33). Thus, Miller '502 teaches use of dark and light or clear visual regions for contrast in a skin-contacting adhesive diagnostic device.
It would have been prima facie obvious before the effective filing date of the claimed invention to modify the adhesive-bearing portion of the modified Khazaka in view of Brehm, Gueret, and Miller '502 such that the contact face included at least two differently-colored parts when viewed from perpendicular towards the contact face, with one part being dark-colored and the other being light-colored. The combination would have been possible because the modified Khazaka already teaches a skin-contacting adhesive-bearing device, Brehm teaches a visually distinguishable skin-contacting indicator portion, Gueret teaches an adhesive skin-contacting portion using color contrast for visual observation of material collected from the skin, and Miller '502 teaches that dark and light or clear visual regions may be selected on an adhesive skin-contacting diagnostic device to improve contrast and visualization. A person of ordinary skill in the art would have understood that differently-colored portions could be provided on different areas of the adhesive-bearing contact face of the modified Khazaka and that selecting one portion as darker and another as lighter would facilitate visual differentiation and observation. A person of ordinary skill in the art would have been motivated to do so in order to improve visual contrast and facilitate evaluation of information presented on the contact face. The benefit would have been easier visual differentiation of the respective portions of the contact face.
Also, regarding claim 9, the modified Khazaka does not expressly teach that the dark-colored part of said contact face has a lightness of 0-2 in the Munsell color system and the light-colored part of said contact face has a lightness of 7-9 in the Munsell color system. Rather, the modified Khazaka teaches dark-colored and light-colored visually contrasting portions as discussed above, but does not expressly quantify the lightness of those portions according to the Munsell color system.
Kosugi is reasonably pertinent to the problem addressed by the claimed device concerning selection of dark and light surface regions that provide sufficient visual contrast. The Instant Application explains that particles collected from the skin are visually apparent against an underlying light-colored background and that collected skin cells are visually apparent against an underlying dark-colored background (Spec. ¶¶[0112], [0117]). Thus, the particular problem includes selecting dark and light backgrounds that permit material or features appearing against those backgrounds to be visually distinguished. Although Kosugi concerns a guidewire rather than a skin-characterization device, Kosugi addresses the same visual-contrast problem by quantitatively selecting light and dark regions so that one region is readily visible against the other. A person of ordinary skill selecting quantitative lightness values for the dark and light regions already provided in the modified Khazaka therefore would reasonably have looked to teachings concerning objective lightness values used to produce visual contrast.
Kosugi teaches quantitative lightness values for visually contrasting light and dark regions using the Munsell color system. Kosugi teaches that base layer 40 is nearly white and has a Munsell lightness "in the range of 7 to 10" (Kosugi, ¶[0019]). Kosugi further teaches that marker 30 is nearly black, has a Munsell lightness in the range of 0 to 7, and that "[t]he Munsell lightness of marker 30 is preferably in the range of 0 to 2" (Kosugi, ¶[0021]). Kosugi explains that the base layer is relatively light while the marker is relatively dark (Kosugi, ¶[0021]). Kosugi further teaches that "the contrast between the marker 30 and the substrate 40 is large, which improves the visibility of the marker 30" (Kosugi, ¶[0054]). Thus, Kosugi teaches the claimed dark-colored lightness range of 0 to 2 and a light-colored lightness range of 7 to 10 that encompasses the claimed range of 7 to 9.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Khazaka in view of Kosugi by selecting the lightness of the already-provided dark-colored portion to be within Munsell 0 to 2 and the lightness of the already-provided light-colored portion to be within Munsell 7 to 9. The modification would have required only selection of the degree of lightness of the existing differently-colored regions and would not have altered their structure or the operation of the skin-contacting device. A person of ordinary skill would have been motivated to make the modification because Kosugi teaches that providing a relatively light region and a relatively dark region with a large contrast improves visibility of one region relative to the other (Kosugi, ¶¶[0019], [0021], [0054]). Kosugi expressly identifies Munsell 0 to 2 as a preferred lightness for the dark region and teaches a Munsell 7 to 10 range for the light region that encompasses the claimed 7 to 9 range. Applying those known quantitative lightness selections to the already-provided dark and light portions of the modified Khazaka would have constituted use of a known visual-contrast technique for its established purpose and would have provided the recited Munsell lightness ranges.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Khazaka (US 5,935,521), hereinafter Khazaka, and further in view of Cantor et al. (US 2014/0243788 A1), hereinafter Cantor, and further in view of Miller (US 4,532,937), hereinafter Miller '937, and further in view of Bazin et al. (US 2002/0065452 A1), hereinafter Bazin, and further in view of Khosravi Simchi et al. (US 2018/0140196 A1), hereinafter Simchi.
Regarding claim 10, the modified Khazaka does not expressly teach that at least one of: said upper surface of said body being non-glare; and said contact face being non-glare. Rather, the modified Khazaka teaches a skin-contacting device whose resulting visual information is intended to be observed and evaluated, but does not expressly describe either surface as "non-glare." Khazaka teaches a microporous sebum-absorbing film which changes appearance based on sebum absorption, wherein "the pores fill up, whereby the film becomes transparent at the corresponding places" (Khazaka, col. 2, ll. 28-38). Thus, Khazaka teaches that visual observation of the device after use is important for evaluating the resulting skin-characterization pattern. In the context of the device as a whole, the surface carrying the information to be observed and analyzed, including the skin-contacting face after use, would be the surface for which glare reduction would improve readability.
Simchi teaches that glare and reflected light interfere with accurate skin observation and imaging, and that device structure and configuration may be selected to minimize such glare effects. In particular, Simchi teaches that a liquid medium "reduces light that is reflected from the surface of the skin and allows visual inspection substantially unobstructed by reflected light" and further teaches apparatus that may be used to produce digital images "substantially unobstructed by reflected ambient and/or stray light" and a body shape selected "so that glare effects may be minimized" (Simchi, ¶¶[0003], [0095], [0097]). Thus, Simchi teaches that reducing glare is a recognized design consideration in devices used for observing skin and skin-related surface features.
It would have been prima facie obvious before the effective filing date of the claimed invention to provide at least the face of the modified Khazaka that is intended to be visually observed for analysis as non-glare, including the contact face after removal, in view of Simchi. The combination would have been possible because the modified Khazaka already teaches a device whose usefulness depends on visually distinguishing contrast between regions of the device corresponding to skin-related information, and Simchi teaches that reflected light and glare can interfere with reliable observation and imaging of skin-related features and therefore should be minimized through device configuration or surface treatment. A person of ordinary skill in the art would have understood that reducing glare on the face of the modified Khazaka being viewed or imaged for evaluation could be readily achieved using known surface treatments such as providing a matte or textured finish, roughening the surface, or applying a light-diffusing or anti-reflective coating, all of which were well-known techniques for reducing specular reflection. A person of ordinary skill in the art would have been motivated to implement such a modification in order to improve the readability and reliability of the visual skin-characterization results by reducing reflective interference during observation or imaging. The benefit of the combination would have been improved visibility of the analyzed surface and more reliable evaluation of skin characteristics.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Khazaka (US 5,935,521), hereinafter Khazaka, and further in view of Cantor et al. (US 2014/0243788 A1), hereinafter Cantor, and further in view of Miller (US 4,532,937), hereinafter Miller '937, and further in view of Bazin et al. (US 2002/0065452 A1), hereinafter Bazin, and further in view of Khosravi Simchi et al. (US 2018/0140196 A1), hereinafter Simchi, and further in view of Tamaki et al. (US 2002/0057345 A1), hereinafter Tamaki.
The modified Khazaka teaches claim 1 as described above.
Regarding claim 12, the modified Khazaka does not expressly teach that said contact face comprises at least one image-correction feature that assists in computerized correction of a distortion of a portion of an acquired image that corresponds to said contact face. Rather, Khazaka teaches a skin-characterizing device having a contact face that is placed against the skin and thereafter visually observed based on the resulting sebum pattern. However, Khazaka does not expressly disclose providing, on that contact face, an image-correction feature for assisting computerized correction of distortion in the corresponding portion of an acquired image.
Bazin teaches that "a calibration member is scanned along with the external portion and/or the image of the transfer member. The calibration member preferably has a predetermined size and/or a predetermined color" (Bazin, ¶[0039]). Bazin further teaches that "the calibration member could have a predetermined size and or color that would enable calibration of an image formed from the scanned image data (for example, via image processing software such as Photoshop) to provide a more exact indication of the size and/or color of characteristics" (Bazin, ¶[0099]). Bazin also teaches the use of a skin-contact-derived transfer member including adhesive material on a backing that is placed against skin and then scanned to obtain an image for analysis (Bazin, ¶¶[0086]-[0087]). Bazin therefore teaches providing a known reference feature in an acquired image to assist computerized correction and calibration of the image.
Simchi teaches that "an annular surface surrounding the aperture... may be used as a reference point to, for example, crop an acquired digital image" and "may include a reference ruler 161 and/or a reference colour chart or colour palette ... to be used for calibration analysis" (Simchi, ¶[0126]). Simchi further teaches that imaging software may detect the reference ruler in the acquired image and use it to measure dimensions and perform image processing (Simchi, ¶¶[0127]-[0128]). Simchi therefore teaches using a known feature appearing in the same acquired image region to assist computerized correction of image geometry.
Tamaki teaches explicit computerized correction of image distortion. In particular, Tamaki teaches that "the image lens distortion can be corrected by an image processing using the internal parameter" (Tamaki, ¶[0005]). Tamaki further teaches "a distortion correction parameter θd for correcting the distortion" (Tamaki, ¶[0017]). Tamaki also teaches that "the obtained distortion correction parameter θd is used to correct the image taken by the camera" (Tamaki, ¶[0020]). Tamaki therefore expressly teaches computerized correction of distortion in an acquired image.
It would have been prima facie obvious before the effective filing date of the claimed invention to modify Khazaka to include, on the contact face, at least one image-correction feature as taught by Bazin, Simchi, and Tamaki in order to assist computerized correction of distortion in the portion of the acquired image corresponding to the contact face, wherein distortion correction requires known reference information within the same image region to accurately correct geometric deformation. Bazin teaches inclusion of a calibration feature in the same imaged region as the skin-contacting surface, Simchi teaches providing a reference feature within that same region for image-based measurement and geometric correction, and Tamaki teaches determining and applying a distortion correction parameter to correct distortion in an acquired image. A person of ordinary skill in the art would have been motivated to incorporate such a feature onto the contact face of Khazaka so that distortion correction could be applied to the portion of the acquired image corresponding to the contact face using known reference information present in that same region, as accurate distortion correction requires co-location of the reference feature and the imaged surface, thereby making placement of the reference feature on the contact face the most direct and predictable implementation. This modification would have been straightforward because the reference feature can be printed or patterned directly on Khazaka's planar contact face without altering device operation, and Tamaki's distortion correction is applied in software to the acquired image. Thus, the combination involves providing a reference feature on the contact face (Bazin/Simchi) and applying distortion correction to the resulting image (Tamaki), yielding improved accuracy and reliability of computerized image analysis. The benefit of the combination would have been improved accuracy of computerized image analysis through explicit correction of distortion in the relevant image portion corresponding to the contact face.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Khazaka (US 5,935,521), hereinafter Khazaka, and further in view of Cantor et al. (US 2014/0243788 A1), hereinafter Cantor, and further in view of Miller (US 4,532,937), hereinafter Miller '937, and further in view of Bazin et al. (US 2002/0065452 A1), hereinafter Bazin, and further in view of Miller (US 5,088,502), hereinafter Miller '502.
The modified Khazaka teaches claim 1 as described above.
Regarding claim 13, the modified Khazaka does not expressly teach that said body comprises a supporting sheet which provides said body with at least one property selected from the group consisting of non-stretchiness, flexibility to conform to the irregularly curved surface of human skin, stiffness and elasticity. Rather, the modified Khazaka teaches a skin-contacting sebum-characterizing device comprising a sebum-indicating region for application to skin, but does not expressly teach that the body comprises a supporting sheet having the recited mechanical property.
Miller '502 teaches such a supporting sheet. In particular, Miller '502 teaches "an opaque, flexible substrate" (Miller '502, claim 1). Miller '502 further teaches that "Device 10 includes a substrate 12 such as, for example, a flexible cardboard layer having a thickness of, for example, approximately 1 to 10 mils thick" (Miller '502, col. 1, ll. 60-68). Miller '502 also teaches that the device is pressed against skin and that the adhesive "under pressure readily flows to conform to the configuration of the skin surface being sampled when substrate 12 with adhesive layer 16 in contact with the skin is pressed against the skin being sampled" (Miller '502, col. 2, ll. 1-12). Thus, Miller '502 teaches a supporting sheet/substrate that provides the body with flexibility to conform to the irregularly curved surface of human skin.
It would have been prima facie obvious before the effective filing date of the claimed invention to provide the body of the modified Khazaka with the supporting sheet taught by Miller '502 so that the body has at least one of the recited properties, namely flexibility to conform to the irregularly curved surface of human skin. The combination would have been possible because Khazaka teaches a sebum-indicating film assembly for application to skin and further teaches that its assembly may be adhered onto an additional support structure from the side opposite the film via support frame 22, while Miller '502 teaches a flexible supporting sheet used as a body for a skin-contacting device. A person of ordinary skill in the art would have been motivated to provide Khazaka's sebum-indicating assembly with such a supporting sheet in order to facilitate handling while maintaining the ability of the device to conform to the skin surface due to the flexibility of the sheet, wherein Khazaka's teaching of support frame 22 shows that the assembly is structurally compatible with attachment to an additional support even though support frame 22 itself is used for evaluation rather than skin application. The combination would have been straightforward because it merely involves using a known flexible sheet as a support body for a skin-contacting assembly for the same purpose, while Khazaka already contemplates mounting the assembly to an additional support structure. The benefit of the combination would have been improved handling and consistent application of the device while preserving conformity to the skin during use.
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Khazaka (US 5,935,521), hereinafter Khazaka, and further in view of Cantor et al. (US 2014/0243788 A1), hereinafter Cantor, and further in view of Miller (US 4,532,937), hereinafter Miller '937, and further in view of Bazin et al. (US 2002/0065452 A1), hereinafter Bazin, and further in view of Miller (US 5,088,502), hereinafter Miller '502.
Regarding claim 14, Khazaka teaches a method for making a device comprising a sebum indicator according to claim 1 (Khazaka, col. 2, ll. 19-27: "the collecting means or measuring means for determining the secretion of sebum from the skin is multi-layered and comprises a sebum absorbing outer film 4", Khazaka teaches a multi-layered sebum-measuring device including a sebum-absorbing film assembly; while Khazaka does not expressly disclose each step of the claimed method of making the device, the disclosed structure necessarily requires assembly of constituent components, and the claimed method corresponds to an obvious sequence of forming and assembling the device components of the modified Khazaka as set forth in the rejection of claim 1, using known fabrication and assembly techniques for layered film devices; see also Abstract and the 103 rejection of claim 1 above); comprising: providing a microporous film assembly comprising a vertical spacer having a front side and a back side, with a microporous film attached to said front side of said vertical spacer (Khazaka, FIG. 3; col. 1, ll. 30-53: "[t]he substrate may be made of two rings clamping the sebum absorbing film between them"; col. 2, ll. 57-65: "FIG. 3 illustrates a second embodiment, wherein the sebum absorbing film 4 is tightened between two rings or frame portions 18, 20... may also be adhered onto a support frame 22, using an adhesive layer in the side of the ring 18 averted from the film 4", showing a microporous film assembly in which the film is held by a surrounding spacer-like ring/frame member, with the film at one side and attachment to further structure from the opposite side. Khazaka further shows that the spacer-supported film assembly is intended to be mounted to an additional support structure, demonstrating structural compatibility with attachment to a supporting sheet).
Also regarding claim 14, Khazaka does not expressly teach providing a sheet of material suitable for being a supporting sheet of a body of the device having a front side and a back side. Rather, Khazaka teaches a skin-contacting sebum-characterizing device comprising a sebum-indicating assembly for application to skin, however, it does not expressly teach the claimed supporting sheet/body.
Miller '502 teaches such a supporting sheet. In particular, Miller '502 teaches "an opaque, flexible substrate" (Miller '502, Claim 1). Miller '502 further teaches that "Device 10 includes a substrate 12 such as, for example, a flexible cardboard layer having a thickness of, for example, approximately 1 to 10 mils thick" (Miller '502, col. 1, ll. 60-68). Thus, Miller '502 teaches a sheet material suitable for being a supporting sheet/body of the device, inherently having a front side and a back side.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Khazaka in view of Miller '502 to have a sheet of material suitable for being a supporting sheet of a body of the device having a front side and a back side. The combination would have been possible because Khazaka teaches a sebum-indicating film assembly for application to skin and further teaches that its assembly may be adhered onto an additional support structure from the side opposite the film via support frame 22, while Miller '502 teaches a flexible supporting sheet used as a body for a skin-contacting device. A person of ordinary skill in the art would have been motivated to provide Khazaka's sebum-indicating assembly with such a supporting sheet in order to facilitate handling and consistent placement of the device on skin while maintaining the ability of the device to conform to the skin surface due to the flexibility of the sheet, wherein Khazaka's teaching of support frame 22 demonstrates structural compatibility with attachment to an additional support even though support frame 22 itself is used for evaluation rather than skin application. The combination would have been straightforward because it merely involves using a known flexible sheet as a support body for a skin-contacting assembly for the same purpose while Khazaka already contemplates mounting the assembly to an additional support structure. The benefit of the combination would have been improved handling and consistent application of the device while preserving conformity to the skin during use.
Also regarding claim 14, the modified Khazaka does not expressly teach covering said front side of said sheet of material with a layer of adhesive. Rather, the modified Khazaka teaches a sebum-indicating assembly for use in a skin-contacting device and further teaches the use of an adhesive layer on the side of the spacer-supported assembly opposite the film for attachment to another structure, but does not expressly teach the claimed supporting sheet having adhesive on its front side.
Cantor teaches such an adhesive-coated supporting sheet. In particular, Cantor teaches "a backing having a first major surface and a second major surface, and a skin-contact adhesive coupled to the second major surface of the backing" (Cantor, ¶[0006]; FIGS. 5 and 9). Cantor further teaches that "The patch 102 can include a backing 110, and an adhesive 112. The backing 110 can include a first major surface 114 and a second major surface 116... and the skin-contact adhesive 112 can be coupled... to the second major surface 116" (Cantor, ¶[0026]). Thus, Cantor teaches a sheet/supporting backing having adhesive on one side.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Khazaka in view of Cantor to have a layer of adhesive covering the front side of the sheet of material. The combination would have been possible because Khazaka teaches a sebum-indicating assembly for use in a skin-contacting device and further teaches the use of adhesive as a bonding interface for attaching the spacer-supported assembly to another structure, while Cantor teaches a supporting sheet/backing having adhesive on one side for a skin-contacting device. A person of ordinary skill in the art would have been motivated to provide the adhesive on the supporting sheet, as taught by Cantor, rather than on the opposed component because Cantor teaches placing the adhesive on the backing/sheet side to provide the adhesive-bearing portion for skin application, while Khazaka already contemplates an adhesive bonding interface. The combination would have been straightforward because it merely involves relocating the known adhesive interface of Khazaka to the sheet/backing side of that interface as taught by Cantor. The benefit of the combination would have been providing an adhesive-bearing supporting sheet for securing the device during use.
Also regarding claim 14, the modified Khazaka does not expressly teach contacting said back side of said vertical spacer of said microporous film assembly with said layer of adhesive covering said front side of said sheet of material where said microporous film assembly is surrounded by a surface of said layer of adhesive, thereby attaching said microporous film assembly to said front side of said sheet of material. Rather, the modified Khazaka teaches attachment of the spacer-supported film assembly from the side opposite the film. In particular, Khazaka teaches that the spacer-supported assembly "may also be adhered onto a support frame 22, using an adhesive layer in the side of the ring 18 averted from the film 4" (Khazaka, col. 2, ll. 57-65). Thus, the modified Khazaka teaches attachment of the spacer-supported film assembly through the side of the spacer opposite the film, but does not expressly teach attachment to the claimed adhesive-coated supporting sheet where the assembly is surrounded by adhesive.
Cantor teaches such an adhesive-coated supporting sheet and surrounding relationship. In particular, Cantor teaches "a backing having a first major surface and a second major surface, and a skin-contact adhesive coupled to the second major surface of the backing" and further teaches "a carrier positioned to couple the microneedle array to the matrix opposite the backing" (Cantor, ¶[0006]). Cantor also teaches that "A portion of the backing and at least a portion of the skin-contact adhesive can extend beyond the skin treatment assembly in at least one direction to form an anchor" (Cantor, ¶[0006]; FIGS. 5 and 9). Further, Cantor teaches that "the matrix 115 can be positioned next to, or within an area of the skin-contact adhesive 112... such that the matrix 115 and the skin-contact adhesive 112 do not substantially overlap" (Cantor, ¶[0027]). Thus, Cantor teaches a supporting sheet having an adhesive layer on one side, with a central functional assembly positioned relative to that adhesive-bearing side such that the backing/adhesive extends beyond the assembly.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Khazaka in view of Cantor to have the back side of the vertical spacer of the microporous film assembly contacted with the adhesive layer on the front side of the sheet of material such that the film assembly is attached to the front side of the sheet and surrounded by adhesive. The combination would have been possible because Khazaka teaches that the spacer-supported assembly is attached from the side opposite the film, while Cantor teaches a supporting sheet having adhesive on one side with the adhesive-bearing sheet extending beyond a central assembly. A person of ordinary skill in the art would have been motivated to attach Khazaka's spacer-supported assembly to Cantor's adhesive-coated supporting sheet in order to mount the assembly on a supporting sheet body while maintaining adhesive around the sebum-indicating region, consistent with Cantor's teaching that the adhesive-bearing portion extends beyond the central assembly. The combination would have been straightforward because it merely involves using the known attachment side of Khazaka's spacer-supported assembly with the known adhesive-bearing sheet arrangement of Cantor in which the adhesive extends beyond the central assembly. The benefit of the combination would have been secure attachment of the spacer-supported film assembly to the supporting sheet while maintaining adhesive around the sebum-indicating region.
Also regarding claim 14, the modified Khazaka does not expressly teach cutting said sheet of material to yield an incipient device comprising a sebum indicator, wherein said cutting is such that a microporous film assembly constituting an incipient sebum indicator of a device is surrounded by a surface of said layer of adhesive constituting an adhesive-bearing portion of a device. Rather, the modified Khazaka teaches cutting layered material to form removable measuring devices. In particular, Khazaka teaches that the measuring means "are prepared for removal by providing a punch cut in a correspondingly layered strip material and may easily be taken from the test strip 8" (Khazaka, col. 2, ll. 52-56). Thus, Khazaka teaches cutting layered material to form individual devices from a multi-layer strip construction, including a sebum-indicating assembly, and therefore teaches cutting a sheet/strip of layered material to yield individual devices, although Khazaka does not expressly teach the claimed adhesive-backed sheet construction in which the film assembly is surrounded by adhesive.
Cantor teaches such an adhesive-backed sheet structure. In particular, Cantor teaches "a backing having a first major surface and a second major surface, and a skin-contact adhesive coupled to the second major surface of the backing" (Cantor, ¶[0006]). Cantor further teaches that "A portion of the backing and at least a portion of the skin-contact adhesive can extend beyond the skin treatment assembly in at least one direction to form an anchor" (Cantor, ¶[0006]). Thus, Cantor teaches an adhesive-backed sheet construction in which the adhesive-bearing portion extends beyond the central assembly.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Khazaka in view of Cantor to have the sheet of material cut to yield an incipient device comprising a sebum indicator, wherein the microporous film assembly is surrounded by a surface of the adhesive layer. The combination would have been possible because Khazaka teaches cutting a layered strip construction to form individual sebum-measuring devices, while Cantor teaches a layered adhesive-backed sheet structure in which an adhesive-bearing portion extends beyond a central assembly. A person of ordinary skill in the art would have been motivated to apply Khazaka's known cutting technique to the adhesive-backed layered sheet construction resulting from the combination of Khazaka and Cantor in order to produce individual devices having the same layered configuration, including an adhesive-bearing portion surrounding the central assembly. The combination would have been straightforward because it merely involves applying a known cutting/punching technique for forming individual devices from a layered strip to another layered sheet construction having analogous structure. The benefit of the combination would have been efficient manufacture of individual adhesive-backed devices while maintaining the adhesive-surrounding configuration of the central assembly.
Regarding claim 15, the modified Khazaka does not expressly teach that said sheet of material has a thickness of between about 50 micrometers and about 450 micrometers. Rather, the modified Khazaka teaches a skin-contacting sebum-characterizing device comprising a sebum-indicating assembly for application to skin, however, it does not expressly teach the claimed thickness of the supporting sheet.
Miller '502 teaches such a thickness. In particular, Miller '502 teaches "Device 10 includes a substrate 12 such as, for example, a flexible cardboard layer having a thickness of, for example, approximately 1 to 10 mils thick" (Miller '502, col. 1, ll. 60-68). Thus, Miller '502 teaches a sheet material having a thickness of about 25.4 to 254 micrometers, which overlaps a portion of the claimed range of between about 50 micrometers and about 450 micrometers, at least over the range of about 50 micrometers to about 254 micrometers.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Khazaka in view of Miller '502 to have a sheet of material having a thickness of between about 50 micrometers and about 450 micrometers. The combination would have been possible because Khazaka teaches a sebum-indicating assembly for application to skin and further teaches that its assembly may be adhered onto an additional support structure from the side opposite the film via support frame 22, while Miller '502 teaches a flexible supporting sheet used as a body for a skin-contacting device having a thickness within the claimed range. A person of ordinary skill in the art would have been motivated to select a sheet thickness within the overlapping taught range in order to provide sufficient handling strength and structural support while maintaining flexibility for conformity to the skin surface. The combination would have been straightforward because it merely involves selecting a known thickness of a known supporting sheet used for the same purpose. The benefit of the combination would have been improved handling and consistent application of the device while preserving conformity to the skin during use.
Regarding claim 16, the modified Khazaka does not expressly teach further comprising prior to said covering said front side of said sheet of material with a layer of adhesive, applying a colorant to said front side of said sheet of material having a desired color pattern. Rather, the modified Khazaka teaches a sebum-indicating assembly for use in a skin-contacting device and further teaches supporting structures and adhesive attachment, however, it does not expressly teach applying a colorant to the front side of the supporting sheet prior to application of adhesive.
Miller '502 teaches such application of a colorant to a supporting sheet. In particular, Miller '502 teaches that "Light absorbing area 14 comprises a dark colored area which may be printed on substrate 12 using standard printing techniques" (Miller '502, col. 1, ll. 60-68; FIG. 1). Thus, Miller '502 teaches applying a colorant to a substrate/sheet material in a defined pattern, and the specific selection of a desired color pattern would have been a matter of design choice.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Khazaka in view of Miller '502 to apply a colorant to the front side of the sheet of material having a desired color pattern prior to applying adhesive. The combination would have been possible because Khazaka teaches a sebum-indicating assembly for application to skin, while Miller '502 teaches a supporting sheet/substrate for a skin-contacting device and further teaches printing a dark colored area on that substrate using standard printing techniques. A person of ordinary skill in the art would have been motivated to apply a colorant to the front side of the supporting sheet in order to provide a desired color pattern and improve visual contrast for subsequent evaluation. Additionally, such a person would have further understood that applying the colorant prior to application of adhesive would have been a matter of routine manufacturing sequence, as printing on a substrate is conventionally performed prior to applying adhesive layers in order to ensure proper adhesion, pattern definition, and to avoid interference with printing processes. The combination would have been straightforward because it merely involves applying a known printed color pattern to a known supporting sheet used for a similar skin-contacting device. The benefit of the combination would have been improved visibility and interpretability of the resulting skin-characterizing pattern during analysis.
Response to Arguments
IDS
Applicant's arguments filed 7/26/2026, pages 7-8, regarding the statement in the previous Office Action that English translations of the YOSHITERU et al. and TROTTER et al. references were not provided have been fully considered and are persuasive. The previous statement that the translations were not provided is withdrawn. The YOSHITERU et al. and TROTTER et al. references and their corresponding English translations have been considered.
Objections
Applicant's arguments filed 7/26/2026, page 8, regarding the objections to claims 1, 13, and 16 have been fully considered and are persuasive. The objections to claims 1, 13, and 16 are withdrawn.
Claim Interpretation
Applicant's arguments filed 7/26/2026, pages 8-9, regarding the previous interpretation of the term "image-correction feature" in claims 11 and 12 under 35 U.S.C. 112(f) have been fully considered and are persuasive as to the ultimate disposition. Upon reconsideration, the previous determination that claims 11 and 12 invoke 35 U.S.C. 112(f) is withdrawn. Claims 11 and 12 are interpreted according to the ordinary meaning of the recited "image-correction feature" in view of the Specification.
35 U.S.C. §112(b)
Applicant's arguments filed 7/26/2026, pages 9-12, regarding the previous rejection of claims 1, 2, 5-16, and 22-26 under 35 U.S.C. 112(b) have been fully considered and are persuasive in part. The previous rejection under 35 U.S.C. 112(b) is not maintained. However, claim 25 is additionally rejected under 35 U.S.C. 112(b) as set forth above.
The numerical inconsistency and parenthetical-language issues in claim 1 are resolved by amendment. The previous rejection based on "fine sebum-absorption pattern" in claim 1 is withdrawn upon reconsideration. The previous rejection of claim 5 based on "substantially different patterns of sebum absorption" is withdrawn in view of the amended claim language and the Specification. The two claim 6 issues concerning "thin" and the antecedent basis of "said microporous film" are resolved by amendment. The previous claim 9 issue concerning the hydration-characterizing and pollution-characterizing portions is moot because that language has been removed. The previous claim 24 issues concerning "rough" and "large" are moot because those terms have been removed. The previous claim 25 rejection based on "stiff and self-supporting" is withdrawn in view of the added objective sag standard. The previous claim 26 rejection concerning the conditions under which a material "can leach" is withdrawn in view of the added normal-storage-or-use conditions. The dependency-based rejections of the remaining claims are therefore also withdrawn.
Applicant's Argument: Applicant traverses the rejection concerning "fine" and argues that "fine wrinkles" is terminology understood by persons of ordinary skill in the cosmetology field.
Examiner's Response: Applicant's argument is persuasive in part. Applicant's discussion of "fine wrinkles" does not directly address the full basis of the previous rejection. The previous rejection concerned "fine" as used to describe the sebum-absorption pattern, rather than whether the phrase "fine wrinkles" is understood in the cosmetology field.
Upon reconsideration, however, the previous indefiniteness position is not maintained. The Specification provides context for distinguishing the recited fine sebum-absorption pattern from other sebum-absorption patterns, including the type of skin information obtainable from the respective patterns and the disclosed relationship between film characteristics and the resulting pattern. In view of that context, the scope of the limitation is reasonably certain. Accordingly, the previous rejection based on "fine sebum-absorption pattern" is withdrawn.
Applicant's Argument: Applicant argues that the Examiner's interpretation of "substantially different patterns of sebum absorption" as meaning patterns that are meaningfully distinguishable is correct. Applicant amended claim 5 to further require that the different films allow the device to provide different types of information about the skin and relies on the Specification and Annex as illustrating the difference between the respective patterns.
Examiner's Response: Applicant's argument is persuasive in part. The statement that "substantially different" means merely "meaningfully distinguishable" would not by itself provide an objective boundary for the limitation. Amended claim 5, however, now further requires the different microporous films to allow the device to provide “different types of information about the skin". The Specification describes the different sebum-absorption patterns in the context of the different skin information obtained from the respective films. In view of the amended claim language and the Specification, the scope of the recited distinction is reasonably certain. Accordingly, the previous rejection based on "substantially different patterns of sebum absorption" is withdrawn.
Because the direct grounds discussed above are no longer maintained, the previous 35 U.S.C. 112(b) rejections of the remaining claims by virtue of their dependency from claims containing those grounds are also withdrawn.
35 U.S.C. §103
Applicant's arguments filed 7/26/2026, pages 12-19, regarding the previous rejections under 35 U.S.C. 103 have been fully considered. Applicant's arguments concerning claim 1 and Applicant's dependency-based arguments concerning the remaining rejected claims are not persuasive.
The rejection of claim 1 over Khazaka in view of Cantor, Miller '937, and Bazin is maintained. The rejection of claim 2 over Khazaka in view of Cantor, Miller '937, and Bazin is maintained. The rejections of claims 10-16, 22, and 23 under 35 U.S.C. 103 are maintained on the grounds set forth above.
Claims 5 and 24 are rejected under 35 U.S.C. 103 over Khazaka in view of Cantor, Miller '937, Bazin, and Kawam as set forth above. The rejection is a new ground of rejection necessitated by Applicant's amendment. Amended claim 5 adds the requirement that the different microporous films allow the device to provide different types of information about the skin, and amended claim 24 removes the recitations of a "rough" sebum-absorption pattern and of "large wrinkles and blemishes." The rejection accordingly relies on additional teachings of Kawam directed to those amended limitations.
The rejections of claims 6-8 under 35 U.S.C. 103 over Khazaka in view of Cantor, Miller '937, and Bazin are maintained, with conforming changes to the rejection of claim 6 to reflect the amended claim language.
Claims 25 and 26 are rejected under 35 U.S.C. 103 over Khazaka in view of Cantor, Miller '937, and Bazin as set forth above. The rejections are new grounds of rejection necessitated by Applicant's amendment. Amended claim 25 adds the requirement that the body sag by no more than 10% when the device is held perpendicular to the gravity vector by one end, and amended claim 26 adds the condition that the adhesive be devoid of leaching material under normal storage or use conditions of the device.
Claim 9 is rejected under 35 U.S.C. 103 over Khazaka in view of Cantor, Miller '937, Bazin, Brehm, Gueret, Miller '502, and Kosugi as set forth above. The rejection is a new ground of rejection necessitated by Applicant's amendment, which replaced the recitations of a "hydration-characterizing portion" and a "pollution-characterizing portion" with Munsell lightness values. Kosugi is newly applied to the added Munsell limitations.
Applicant's Argument: Applicant argues that a person of ordinary skill in the art would not have been motivated to select a sebum-absorbing microporous polypropylene film having a “thickness of less than about 20 micrometers”. Applicant argues that the previously stated advantages of improved flexibility, skin conformity, and pattern definition are not expressly taught by the references. Applicant further argues that Khazaka's 20 to 30 micrometer film requires support, that Miller '937 identifies a 25 micrometer film as a preferred embodiment and allegedly requires a supporting adhesive layer, and that thinner films were known to be more flimsy and expensive. Applicant therefore contends that the cited art and general knowledge teach away from the claimed thinner film.
Examiner's Response: Applicant's argument is not persuasive. Regarding claim 1, a reason supporting an obvious modification or selection need not be expressly stated in the prior art itself where the Examiner provides an articulated reason having a rational technical underpinning. See MPEP §§ 2141 and 2143; KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
The selection made in the rejection is also directly within the thickness range expressly taught by Miller '937. Miller '937 teaches suitable microporous films having a thickness of about 0.01 to 0.05 mm and specifically states that a CELGARD microporous polypropylene film having a thickness of about 0.01 to 0.03 mm has been found suitable. Miller '937, col. 4, ll. 1-14. These ranges correspond to about 10 to 50 micrometers and about 10 to 30 micrometers and therefore include thicknesses of less than about 20 micrometers. A claimed range that overlaps a range disclosed by the prior art ordinarily establishes a prima facie case of obviousness. See MPEP § 2144.05. This confirms the previously stated selection of a thickness toward the thinner portion of Miller '937's disclosed range rather than supplying a different basis for the rejection.
Applicant's criticism of the previously stated flexibility and skin-conformity considerations is also not persuasive. Applicant itself relies on the proposition that films below about 20 micrometers are comparatively flimsy, which is consistent with such thinner films being comparatively flexible. For a film intended to contact an irregular skin surface, increased flexibility predictably affects conformity to that surface. Khazaka's use of a substrate or frame to maintain its film substantially tight and planar addresses handling and optical evaluation of the flexible film. Khazaka does not criticize or discourage use of the disclosed microporous film for sebum measurement. Khazaka, col. 1, ll. 30-53; col. 2, ll. 28-65. Applicant's disagreement with the stated pattern-definition benefit does not negate Miller '937's express teaching that films within the claimed thickness region are suitable or the other reasons previously stated for selecting the thinner film.
Miller '937's preferred embodiment does not teach away from the remainder of its expressly disclosed suitable range. A preference for a particular embodiment does not criticize, discredit, or discourage other thicknesses that the reference expressly identifies as suitable.
Applicant's adhesive-thickness argument is likewise not persuasive. Miller '937 discloses adhesive coating weight, not an adhesive thickness of 15 to 60 micrometers. Miller '937, col. 4, ll. 35-68. Applicant's conversion of coating weight to thickness depends on an assumed adhesive density. Claim 1 also recites the thickness of the “first sebum-absorbing hydrophobic microporous polypropylene film", not the combined thickness of the film and an adhesive coating. Miller '937 states that adhesive thickness is not critical and teaches that, for a general evaluation of sebaceous-gland activity, the microporous film may be applied directly to the skin without an adhesive coating or with the adhesive-coated side facing away from the skin. Miller '937, col. 4, l. 60 to col. 5, l. 5. Applicant's proposed addition of an adhesive thickness to the expressly disclosed film thickness therefore does not remove Miller '937's teaching of microporous films within the claimed thickness range.
Applicant's reliance on the submitted materials concerning handling and cost of thinner films also does not establish teaching away. Even assuming that thinner films may present handling or cost disadvantages, Miller '937 expressly teaches films within the claimed thickness region as suitable for sebum collection, while Khazaka demonstrates that supporting structures for flexible sebum-absorbing films were known. The asserted disadvantages therefore do not establish that a person of ordinary skill would have been discouraged from the claimed selection. Further, the submitted Gemini query outputs were generated in May 2026 and do not establish what was commonly known to a person of ordinary skill in the art before the June 21, 2021 effective filing date. Those later-generated outputs therefore do not establish the state of the art or the level of ordinary skill at the relevant time.
Applicant's Argument: Applicant argues that Cantor is unrelated to characterizing skin, makes no mention of sebum, and does not teach a sebum-absorbing microporous film configured to generate a fine sebum-absorption pattern. Applicant therefore contends that Cantor does not remedy the alleged deficiencies of Khazaka.
Examiner's Response: Applicant's argument is not persuasive. Regarding claim 1, Cantor is not relied upon to teach the sebum-absorbing microporous polypropylene film or the information obtained from the sebum-absorption pattern. As set forth in the rejection above, Cantor is relied upon for the “adhesive-bearing portion that surrounds a surface of said sebum indicator". Cantor teaches a skin-contact adhesive on a backing that extends beyond a central skin-treatment assembly to form an anchor and further teaches an embodiment in which the anchor surrounds the central flap on all sides. Cantor ¶¶[0006], [0083]; claim 22. Cantor's different central skin-treatment function does not detract from the skin-contact adhesive arrangement for which Cantor is relied upon.
Applicant's Argument: Applicant argues that Bazin does not teach or suggest a sebum-absorbing microporous film configured to generate the claimed fine sebum-absorption pattern and therefore does not remedy the alleged deficiencies of Khazaka.
Examiner's Response: Applicant's argument is not persuasive. Regarding claim 1, Bazin is not relied upon to provide the microporous polypropylene film already taught by Khazaka and Miller '937. As set forth in the rejection above, Miller '937 teaches evaluating the pattern produced by a skin-contacting microporous sebum-absorbing film by observing the location, number, and size of translucent areas associated with active sebaceous glands. Bazin is relied upon for known image-based evaluation of wrinkle-related skin characteristics. Bazin expressly identifies wrinkles, crows eyes, and skin pores among the skin characteristics evaluated from scanned image data. Bazin, ¶[0012]; claim 2.
Applicant's own discussion of Bazin ¶[0087] further demonstrates that Bazin is not unrelated to analysis of skin-contact-derived surface patterns. Bazin teaches computerized analysis of an image obtained from a skin-contact transfer member, including SEBUTAPE, and discusses transferred skin material and sebum-related analysis. This disclosure is consistent with the image-analysis use relied upon in the rejection and answers Applicant's characterization of Bazin as unrelated. Bazin ¶[0087] is not relied upon as a substitute for the teachings previously relied upon from Khazaka and Miller '937.
The rejection therefore relies on the combined teachings of the references for the respective features for which they are cited. Bazin need not independently disclose the microporous film already supplied by Khazaka and Miller '937.
Applicant's Argument: Applicant argues that the Annex establishes an unexpected technical effect because a 16 micrometer film produces a fine sebum-absorption pattern useful for pore and wrinkle information while a 36 micrometer film produces a different pattern useful for qualitative oiliness information. Applicant argues that, absent this allegedly unexpected effect, a person of ordinary skill would not have selected a film having a thickness below about 20 micrometers.
Examiner's Response: Applicant's argument is not persuasive. Regarding claim 1, the Annex and Applicant's asserted unexpected results have been considered but do not outweigh the prima facie case of obviousness.
The Annex compares films identified by Applicant as having thicknesses of 16 micrometers and 36 micrometers. That comparison does not establish criticality at the claimed boundary of less than about 20 micrometers. Miller '937 expressly teaches suitable microporous polypropylene films having thicknesses from about 10 to 30 micrometers, which encompasses the 16 micrometer thickness relied upon by Applicant.
The Annex also does not establish on its face that thickness was the only material variable responsible for the depicted difference. Claim 1 separately recites pore size, porosity, and air permeability, while the Annex does not provide corresponding values for the compared films or otherwise establish that those and other relevant test conditions were controlled. A comparison between a 16 micrometer film and a 36 micrometer film therefore does not establish that an unexpected change occurs at about 20 micrometers or establish unexpected results commensurate in scope with the claimed subject matter. See MPEP § 716.02.
Accordingly, the Annex does not establish that the claimed thickness region is critical or otherwise overcome Miller '937's express teaching of suitable microporous polypropylene films within the claimed thickness range.
Applicant's Argument: Applicant argues that the rejections of claims 2, 5-16, and 22-26 cannot be proper because those rejections rely, directly or indirectly, on the propriety of the rejection of claim 1, which Applicant contends should be withdrawn.
Examiner's Response: Applicant's argument is not persuasive. For the reasons discussed above, the rejection of claim 1 is maintained. Applicant has not identified a separate deficiency in the prior-art findings directed to the additional limitations of claims 2, 5-16, and 22-26. Accordingly, Applicant's argument that the respective rejections fail because the claim 1 rejection is allegedly improper does not establish error in those rejections. To the extent amendments to particular claims required amendment-responsive changes to the applicable rejection, those changes are addressed in the respective rejection above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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