DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 13-15, 19, 21, 25-28, 37, and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0276196 A1 to Niederauer et al. (“Niederauer”) in view of US 3,221,739 A to Rosenthal.
As to claim 1, Niederauer discloses a skin-piercing component of a skin penetration device, wherein the skin-piercing component has a base and one or more piercing elements extending from the base (see Fig 13, element 222 and Fig 14, element 228 – piercing element 228 projects down from a base), and wherein the skin-piercing component has a rest configuration and is configured to be biased towards the rest configuration such that it may be deformed but returns to the rest configuration when the deforming force is removed (see Fig 14, element 230 and [0066] – “Biasing members 230 are provided to urge actuation layer 222 away from allergen layer 202 prior to actuation. In the illustrated embodiment, biasing members 230 comprise four leaf springs, although different types and orientations of springs or other mechanical items may be used.”).
Niederauer fails to disclose wherein the one or more piercing elements are formed by punching out a part of the base of the skin-piercing component and bending the punched-out part away from the base.
This is shown by Rosenthal (see Fig 7 and col 3, ln 60-67 – “The base 32 of the perforating member preferably is a very thin circular flat metal disc or late, and the projections 34 are punched or struck out therefrom.”).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the teachings of Niederauer and Rosenthal in order to achieve the predictable result that is a piercing member that is easy to machine.
As to claim 13, Niederauer discloses skin penetration device for administering a test substance to the skin of a recipient, the skin penetration device comprising:
a first layer (see Fig 13, element 232),
a second layer disposed on the first layer, the second layer comprising at least one protrusion thereby providing a hollow space within the protrusion for containing a substance to be applied to the skin of the recipient, and wherein the first layer comprises an aperture and is arranged such that the protrusion of the second layer is locatable or is located within the aperture (see Fig 13, element 204 and 208),
a third layer disposed on the second layer, and a skin-piercing component, wherein the skin-piercing component has a base and one or more piercing elements extending from the base, and wherein the skin-piercing component has a rest configuration and is configured to be biased towards the rest configuration such that it may be deformed but returns to the rest configuration when the deforming force is removed, and the skin-piercing component being disposed within and/or above the aperture of the first layer and between the second and third layers (see Fig 13, element 222 and treatment of claim 1).
Niederauer fails to disclose wherein the one or more piercing elements are formed by punching out a part of the base of the skin-piercing component and bending the punched-out part away from the base.
This is shown by Rosenthal (see Fig 7 and col 3, ln 60-67 – “The base 32 of the perforating member preferably is a very thin circular flat metal disc or late, and the projections 34 are punched or struck out therefrom.”).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the teachings of Niederauer and Rosenthal in order to achieve the predictable result that is a piercing member that is easy to machine.
As to claim 14, Niederauer further discloses wherein the second layer comprises a plurality of protrusions, the first layer comprises a plurality of corresponding apertures, and there is a corresponding plurality of skin-piercing components (see Fig 13).
As to claim 15, Niederauer further discloses wherein the skin-piercing component has a width dimension, and the aperture of the first layer has a width dimension, wherein the width of the aperture is less than the width of the skin-piercing component (see Fig 13, element 232 – small apertures are formed when the piercing member pierces the layer and it is smaller than the wide of the skin-piercing component when less than the full depth of the piercing member is inserted).
As to claim 19, Niederauer further discloses wherein the third layer has one or more protrusions that are arranged extending over the aperture or apertures of the first layer, wherein the skin-piercing component is located within the protrusion (see treatment of claim 14).
As to claim 21, Niederauer further discloses wherein the skin-piercing component is adhered to, held by, or integrally formed with the third layer, and wherein the third layer conforms to the shape of the skin-piercing component when the skin penetration device is assembled (see Fig 13).
As to claim 25, Niederauer discloses a skin penetration device for administering a test substance to the skin of a recipient, the skin penetration device comprising:
a first layer (see Fig 13, element 232),
a second layer disposed on the first layer (see Fig 13, element 210), the second layer comprising at least one protrusion (see Fig 13, element 212) thereby providing a hollow space within the protrusion and between the first and second layers for containing a substance to be applied to the skin of the recipient (piercing element places substance 208 between first end 214 and second end 216),
a third layer disposed on the second layer, the third layer comprising an aperture and being arranged such that the protrusion of the second layer is located within the aperture (see Fig 13, element 208 – when piercing element pierces 208, an aperture is created within the protrusion),
a fourth layer disposed on the third layer, covering the aperture of the third layer (see Fig 13-15, element 222), and a skin-piercing component (Fig 15, element 228), wherein the skin- piercing component has a base and one or more piercing elements extending from the base, and wherein the skin-piercing component has a rest configuration and is configured to be biased towards the rest configuration such that it may be deformed but returns to the rest configuration when the deforming force is removed, the skin-piercing component being disposed within and/or above the aperture of the third layer and between the second and fourth layers (see Fig 13, elements, 222, 228 and 230 and treatment of claim 1).
Niederauer fails to disclose wherein the one or more piercing elements are formed by punching out a part of the base of the skin-piercing component and bending the punched-out part away from the base.
This is shown by Rosenthal (see Fig 7 and col 3, ln 60-67 – “The base 32 of the perforating member preferably is a very thin circular flat metal disc or late, and the projections 34 are punched or struck out therefrom.”).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the teachings of Niederauer and Rosenthal in order to achieve the predictable result that is a piercing member that is easy to machine.
As to claim 26, Niederauer further discloses wherein the second layer comprises a plurality of protrusions, the third layer comprises a plurality of corresponding apertures, and there is a corresponding plurality of skin-piercing components (see Fig 17 in conjunction with the treatment of claim 25).
As to claim 27, Niederauer further discloses wherein wherein the skin-piercing component is adhered to or integrally formed with the fourth layer (see Fig 15).
As to claim 28, Niederauer further discloses wherein wherein the thickness of the third layer functions to space the fourth layer, and therefore the skin-piercing component, apart from the protrusion of the second layer (see Fig 17, element 220).
As to claim 37, Niederauer further discloses wherein the protrusion of the second layer is configured to receive and guide the skin-piercing component and wherein the protrusion of the second layer has a textured surface (see Fig 17, element 212 – Examiner notes every surface as some texture).
As to claim 41, Niederauer further discloses wherein the skin-piercing component is configured to provide tactile feedback to the user when sufficient force has been applied to the component (spring 230 provides tactile feedback that the user can learn so that sufficient force is applied).
Claim(s) 2, 4-7, 9, 30, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Niederauer in view of Rosenthal as applied to claim 1 above, and further in view of US 2011/0105951 A1 to Bernstein et al. (“Bernstein”).
As to claim 2, neither Niederauer nor Rosenthal discloses wherein the base is substantially dome shaped, and wherein the piercing element is arranged extending from the top of the dome in a direction past the bottom of the dome.
However, this is shown by Bernstein (see Fig 7A-C and [0161]-[0164]). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the leaf springs of Niederauer using the domed reversibly deformable structure of Bernstein in order to achieve the predictable result of allowing individual use of each testing element.
As to claim 4, Bernstein further discloses wherein the base is configured to enable the base to move between the dome shape in the rest configuration to a flattened or inverted configuration (see Fig 7A-C).
As to claim 5, Bernstein further discloses wherein the base of the skin-piercing component has one or more incisions or cut-outs to enable it to be flattened or inverted (see [0164] “The reversibly deformable structure may have, for instance, a generally domed shape (e.g., as in a snap dome), and be circular (no legs), or the reversibly deformable structure may have other shapes, e.g., oblong, triangular (3 legs), square (4 legs), pentagonal (5 legs), hexagonal (6 legs), spider-legged, star-like, clover-shaped (with any number of lobes, e.g., 2, 3, 4, 5, etc.), or the like. The reversibly deformable structure may have, in some embodiments, a hole, dimple, or button in the middle.”).
As to claim 6, Bernstein further discloses wherein the element is arranged to spring from the rest configuration to a flattened or inverted configuration when a sufficient force has been applied, wherein the sudden change in configuration when the skin-piercing component is pressed towards the skin provides the person administering the device with tactile feedback and assures the person that sufficient force has been applied and the skin-piercing component has pierced the skin (see [0164]).
As to claim 7, neither Niederauer nor Rosenthal discloses wherein the base has an inner portion and an outer portion, and wherein the outer portion is formed of a plurality of flanges extending out from the inner portion, and wherein the piercing element is connected to the base at the inner portion.
However, this is disclose by Bernstein (see [0164] “The reversibly deformable structure may have, for instance, a generally domed shape (e.g., as in a snap dome), and be circular (no legs), or the reversibly deformable structure may have other shapes, e.g., oblong, triangular (3 legs), square (4 legs), pentagonal (5 legs), hexagonal (6 legs), spider-legged, star-like, clover-shaped (with any number of lobes, e.g., 2, 3, 4, 5, etc.), or the like. The reversibly deformable structure may have, in some embodiments, a hole, dimple, or button in the middle.”).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the leaf springs of Niederauer using the domed reversibly deformable structure of Bernstein in order to achieve the predictable result of allowing individual use of each testing element. The particular shape would have also been obvious given the explicit suggestion to so construct this structure by Bernstein.
As to claim 9, Bernstein further discloses wherein at least part of the outer portion is deflected towards the pointed or sharpened part or end of the piercing element, and wherein the base slopes downwardly away from where it is connected to the piercing element, the slope extending in a direction towards the pointed or sharpened part/end of the piercing element, or towards the axis of the piercing element (see Fig 7A-C and [0161]-[0164]).
As to claims 30 and 32, neither Niederauer nor Rosenthal discloses wherein the fourth layer has a protrusion arranged extending over the aperture of the third layer, and wherein the skin-piercing component is located within the protrusion, wherein the protrusion of the fourth layer is reinforced.
However, Bernstein discloses a protrusion arranged extending over an aperture wherein the skin-piercing component is located within the protrusion, wherein the protrusion of the fourth layer is reinforced (see Figs 7A-C, element 700 and [0161]-[0164]). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the fourth layer of Niederauer using the reinforced protrusion of Bernstein in order to provide the predictable result of making the piercing element easier to depress.
Conclusion
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/ERIC J MESSERSMITH/ Primary Examiner, Art Unit 3791