DETAILED ACTION
This action is pursuant to claims filed on 10/25/2024. Claims 1-22 are pending. A first action on the merits of claims 1-22 is as follows.
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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. The orientation feature of claim 10 and the alignment feature of claim 11 are introduced as two distinct, separate features, however they are only labeled as one combined feature in the drawings. Therefore, the orientation feature and the alignment feature must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “1202” has been used to designate both “overlays” in paragraph [0090] and “instruction set” in paragraph [0091].
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "1206" and "1202" have both been used to designate “instruction set”.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Reference character “406” in Figure 4 does not appear in the specification
Reference character “900” in Figures 9, 14, and 15 does not appear in the specification
Reference character “1000” in Figure 10 does not appear in the specification
Reference character “”1204” in Figure 12 does not appear in the specification
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5-8, 12-13, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baldo (US 5099857).
Regarding independent claim 1, Baldo teaches a multi-layer contact patch (Column 1, lines 6-12: “The present invention relates to a novel disposable testing device for skin testing human subjects for immediate hypersensitivity (allergic) or delayed hypersensitivity (cell-mediated) immune reactions. The testing device comprises one or more separate needles each in combination with a small reservoir of antigen test reagent in a strip, sheet or patch format”), comprising:
a shield layer releasably coupled to an adhesive layer (The bottom layer 9 is the shield layer, the lock-tack adhesive 16 is the adhesive layer; Column 4, lines 13-17: “The bottom layer (9), seals, protects and ensures the sterility of the unit. It is removed prior to the start of the test. The removal of this layer exposes a layer of low-tack adhesive (16), shown bonded to the transparent layer (10)”);
the adhesive layer at least partially defining and fixably coupled to an allergen complex layer (Column 5, lines 22-26: “The top covering layer (14) which could be made of a flexible material such as an ionomer resin, e.g., Surlyn (Registered Trade Mark) is domed at (14') to provide the space which the needle (3) and reservoir (5) occupy”. The allergen complex layer is the top layer 14 and the domed location at 14’. Fig. 10 shows the adhesive layer 1 coupled to the allergen complex layer 14.);
the allergen complex layer defining a plurality of allergen complex cavities (Reservoir 5 is the allergen complex cavities; Figs. 8-10 show multiple reservoirs in the top layer); and
wherein at least a subset of the plurality of allergen complex cavities comprise an allergen complex positioned therein (Column 4, lines 61-62: “the antigen solution (1) is contained in a reservoir (5)”; Column 3, lines 10-19: “After placement of the strip or patch on the skin, light direct finger pressure on each unit both releases the solution containing the antigen and causes the needle to penetrate the skin to a limited depth insufficient to draw blood. The antigen solution then infiltrates the site of the needle puncture causing a limited exposure of the intradermal or subcutaneous tissues to the antigen. The immunological response to such exposure is determined after the appropriate time, depending on the immune response involved.”; Column 1, lines 6-12: “The present invention relates to a novel disposable testing device for skin testing human subjects for immediate hypersensitivity (allergic) or delayed hypersensitivity (cell-mediated) immune reactions. The testing device comprises one or more separate needles each in combination with a small reservoir of antigen test reagent in a strip, sheet or patch format”. The antigen solution is the allergen complex, which is used to test the allergic response.), each allergen complex comprising an absorbent matrix and an allergen (Column 2, lines 28-40: “said device comprising a hollow body providing a sealed chamber, a needle mounted within said chamber and movable to extend beyond said body to penetrate a patient's skin to a predetermined depth, a test reagent within said chamber, and wherein said device is manipulable by a user to reduce the volume of said chamber to release said reagent and to cause penetration of said needle by moving the needle to extend beyond said body, manipulating said device to release said reagent on to the skin and to cause penetration of the skin by said needle, observing and recording any skin reaction resulting therefrom after an appropriate time interval.”; Column 2, line 47: “the reagent will be an antigen”; Column 2, lines 64-66: “The reagent may be conveniently contained within a capsule, reservoir or porous matrix or may contain an additive to form a paste or gel.”. The test reagent is the same as the antigen solution, which includes the porous matrix and the antigen, which can be an allergen, as the device is testing for allergies.).
Regarding claim 2, Baldo teaches the multi-layer contact patch of claim 1, further comprising a sealing layer interposed between the shield layer and the plurality of allergen complex cavities, wherein the sealing layer is releasably coupled to the shield layer and the plurality of allergen complex cavities (Transparent layer 10 is shown between the shield layer and the plurality of allergen complex cavities in Figure 10, with the low-tack adhesive layers 16 between both the sealing layer and the allergen cavities, therefore being releasably coupled to these layers.).
Regarding claim 3, Baldo teaches the multi-layer contact patch of claim 1, wherein the allergen complex layer defines between 2 and 48 allergen complex cavities, inclusive (Figs., 8 and 11 show 8 allergen complex cavities, which is between 2 and 48 cavities.).
Regarding claim 5, Baldo teaches the multi-layer contact patch of claim 1, wherein the adhesive layer further comprises a perforation pattern (Fig. 7 shows perforations between sections, which includes having a perforation pattern within the adhesive layer; Column 5, lines 16-19: “FIG. 7 depicts a preferred embodiment of the individual skin test units containing the same single antigen solution arranged in a sheet form, so that the single units can be individually separated.”).
Regarding claim 6, Baldo teaches the multi-layer contact patch of claim 5, wherein the perforation pattern comprises a plurality of perforations between adjacent ones of the plurality of allergen complex cavities (Fig. 7 shows perforations between sections, which includes having a perforation pattern within the adhesive layer; Column 5, lines 16-19: “FIG. 7 depicts a preferred embodiment of the individual skin test units containing the same single antigen solution arranged in a sheet form, so that the single units can be individually separated.”).
Regarding claim 7, Baldo teaches the multi-layer contact patch of claim 5, wherein the perforation pattern comprises a plurality of perforations between adjacent groups of the plurality of allergen complex cavities (Fig. 7 shows perforations between sections, which includes having a perforation pattern within the adhesive layer; Column 5, lines 16-19: “FIG. 7 depicts a preferred embodiment of the individual skin test units containing the same single antigen solution arranged in a sheet form, so that the single units can be individually separated.”).
Regarding claim 8, Baldo teaches the multi-layer contact patch of claim 1, wherein the allergen complex layer further comprises a scoring pattern (Fig. 7 shows a scoring pattern between sections, which includes having a scoring pattern within the adhesive layer; Column 5, lines 16-19: “FIG. 7 depicts a preferred embodiment of the individual skin test units containing the same single antigen solution arranged in a sheet form, so that the single units can be individually separated.”).
Regarding claim 12, Baldo teaches the multi-layer contact patch of claim 1, wherein each one of the allergen complexes comprises a distinct allergen composition (Figs. 8 and 11 show each allergen complex containing a distinct allergen composition).
Regarding claim 13, Baldo teaches the multi-layer contact patch of claim 12, wherein the distinct allergen compositions of the allergen complexes are selected to form an allergen panel (Figs., 8 and 11 show the distinct allergen compositions forming an allergen panel.).
Regarding claim 18, Baldo teaches the multi-layer contact patch of claim 1, wherein at least one of the allergen complexes comprises a control composition (Figs. 8 and 11 show positive and negative controls, which are the control compositions.).
Regarding claim 19, Baldo teaches the multi-layer contact patch of claim 1, wherein the absorbent matrix is a gel (Column 2, lines 64-66: “The reagent may be conveniently contained within a capsule, reservoir or porous matrix or may contain an additive to form a paste or gel”).
Regarding claim 20, Baldo teaches the multi-layer contact patch of claim 1, wherein the adhesive layer comprises a surface area that is in direct contact with a user’s skin for a duration of a topical allergen test (Abstract: “A disposable medical testing device (17) adapted to be held against the skin of a patient, which enables the performance of skin testing for the diagnosis of both immediate hypersensitivity and delayed hypersensitivity immune reactions”; Column 2, lines 36-40: “manipulating said device to release said reagent on to the skin and to cause penetration of the skin by said needle, observing and recording any skin reaction resulting therefrom after an appropriate time interval.”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Baldo as applied to claim 1 above, and further in view of Baldo.
Regarding claim 4, Baldo teaches the multi-layer contact patch of claim 1.
Baldo discloses wherein the allergen complex layer defines 8 allergen complex cavities in Figure 8, however Baldo does not teach 16 cavities,
However, it would have been obvious to one of ordinary skill in the art to include 16 cavities as it can increase the amount of allergens that can be tested, which increases the amount of results that can be obtained. Additionally, it is a simple duplication of parts to include more cavities than presented, and would not change the functionality of the device.
Claims 9, 17, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Baldo as applied to claims 1, 13, and 20 above, and further in view of Hamann (US 20110264003).
Regarding claim 9, Baldo teaches the multi-layer contact patch of claim 1.
However, Baldo does not teach wherein the plurality of allergen complex cavities comprise a shape pattern comprising at least two distinct shapes, wherein each of the plurality of allergen complex cavities comprise a selected one of the at least two distinct shapes.
Hamann discloses a test chamber for allergy test units. Specifically, Hamann teaches wherein the plurality of allergen complex cavities comprise a shape pattern comprising at least two distinct shapes, wherein each of the plurality of allergen complex cavities comprise a selected one of the at least two distinct shapes ([0069]: “As shown in FIGS. 7-9, the test chambers 400, 500, 600 have different geometric shapes. The test chamber 400 has a rectangular-shaped ridge 402. The test chamber 500 has a triangular shape ridge 502. The test chamber 600 has an octagonal-shaped ridge 502. In other embodiments, the test chamber can be formed to have various other shapes. Such different geometric shape test chambers can be helpful for distinguishing an allergic reaction from a skin irritation. The skin irritation normally will not appear in geometric shapes, whereas the allergic reaction to an allergen contained in a geometric shape test chamber will result in a skin reaction area corresponding to the geometric shape of the test chamber”). Baldo and Hamann are analogous art as they are both directed to the same field of endeavor and are both related to allergen diagnostic patches.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the different shapes from Hamann into the patch from Baldo as it allows the cavities to be formed in the ideal shape relative to the allergy that is being tested in each specific cavity, which can increase the detection capabilities and provide a more accurate test result for allergen testing.
Regarding claim 17, Baldo teaches the multi-layer contact patch of claim 13.
However, Baldo does not teach wherein the allergen panel comprises at least one of a mining panel, an agriculture panel, a metal panel, a pediatric panel, a fragrance panel, an oil and gas panel, a refining panel, a manufacturing panel, a carpentry panel, a health care panel, a hospital panel, a dye panel, a textile panel, surgical panel, a dental panel, a hairdresser panel, a specified exposure panel, or a food panel.
Hamann teaches wherein the allergen panel comprises at least one of a mining panel, an agriculture panel, a metal panel, a pediatric panel, a fragrance panel, an oil and gas panel, a refining panel, a manufacturing panel, a carpentry panel, a health care panel, a hospital panel, a dye panel, a textile panel, surgical panel, a dental panel, a hairdresser panel, a specified exposure panel, or a food panel ([0061]: “The test chamber 104 is adapted to hold liquid allergens (both liquid and alcohol based), petrolatum based allergens, consumer products, and raw food allergens”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the specific types of allergen panel testing from Hamann into the patch from Baldo as Baldo is silent on the specific type of allergens tested, and Hamann teaches specific types of allergens that can be tested in an analogous device.
Regarding claim 21, Baldo teaches the multi-layer contact patch of claim 20.
However, Baldo does not teach wherein the duration is at least two days.
Hamann teaches wherein the duration is at least two days ([0024]: “The ridge is configured to temporarily indent a test subject's skin when the test chamber is placed on the test subject with a light pressure and contain the allergen within the reservoir against the test subject's skin during a 48 hour test period”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the duration from Hamann into the device from Baldo as Baldo is silent on the duration of the testing, and Hamann teaches a suitable duration of testing in an analogous device.
Regarding claim 22, Baldo teaches the multi-layer contact patch of claim 20.
However, Baldo does not teach wherein the duration is at least two hours.
Hamann teaches wherein the duration is at least two hours ([0024]: “The ridge is configured to temporarily indent a test subject's skin when the test chamber is placed on the test subject with a light pressure and contain the allergen within the reservoir against the test subject's skin during a 48 hour test period”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the duration from Hamann into the device from Baldo as Baldo is silent on the duration of the testing, and Hamann teaches a suitable duration of testing in an analogous device.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Baldo as applied to claim 1 above, and further in view of Smith (US 20170007170).
Regarding claim 10, Baldo teaches the multi-layer contact patch of claim 1.
However, Baldo does not teach the patch further comprising at least one orientation feature, each of the at least one orientation features comprising an opening extending through at least one of the adhesive layer or the allergen complex layer.
Smith discloses an allergy skin test device. Specifically, Smith teaches the patch further comprising at least one orientation feature, each of the at least one orientation features comprising an opening extending through at least one of the adhesive layer or the allergen complex layer ([0024]: “the skin viewing portion can include an aperture through the support strip. For example, the aperture can be a hole or slit penetrating through the support strip. In one example, the aperture can be oriented in a central area of the allergen portion. When the device is applied to the skin of a subject, the device can facilitate viewing of an exposed area of the skin through the aperture. The aperture can have a diameter of about 1 mm to about 1 cm, although this should not be considered limiting in any way”. The aperture is the orientation feature, which is a hole through the entire device, which includes the adhesive layer and allergen complex layer.). Baldo and Smith are analogous art as they are both directed to the same field of endeavor and are both related to allergen diagnostic patches.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the orientation feature from Smith into the device from Baldo as it allows the user to orient themselves in relation to the orientation feature while viewing the patch, which can allow the user to interpret the device easier and more correctly.
Regarding claim 11, Baldo teaches the multi-layer contact patch of claim 1.
However, Baldo does not teach the patch further comprising at least one alignment feature, each of the at least one alignment features comprising an opening extending through at least one of the adhesive layer or the allergen complex layer.
Smith discloses an allergy skin test device. Specifically, Smith teaches the patch further comprising at least one alignment feature, each of the at least one alignment features comprising an opening extending through at least one of the adhesive layer or the allergen complex layer ([0024]: “the skin viewing portion can include an aperture through the support strip. For example, the aperture can be a hole or slit penetrating through the support strip. In one example, the aperture can be oriented in a central area of the allergen portion. When the device is applied to the skin of a subject, the device can facilitate viewing of an exposed area of the skin through the aperture. The aperture can have a diameter of about 1 mm to about 1 cm, although this should not be considered limiting in any way”. The aperture is the orientation feature, which is a hole through the entire device, which includes the adhesive layer and allergen complex layer.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the alignment feature from Smith into the device from Baldo as it allows the user to orient themselves in relation to the orientation feature while viewing the patch, which can allow the user to interpret the device easier and more correctly.
Claims 14 is rejected under 35 U.S.C. 103 as being unpatentable over Baldo as applied to claim 13 above, and further in view of Chang (“Allergy Testing: Common Questions and Answers”).
Regarding claim 14, Baldo teaches the multi-layer contact patch of claim 13.
However, Baldo does not teach wherein the allergen panel comprises a selected group of allergens according to an expected population incidence rate.
Chang discloses common methods and practices for allergy testing. Specifically, Chang teaches
wherein the allergen panel comprises a selected group of allergens according to an expected population incidence rate (“An estimated 10% to 30% of the global population has an allergic disease. Clinical presentations of allergic diseases, respiratory infections, and autoimmune conditions have similar features. Allergy and immunologic testing can help clarify the diagnosis and guide treatment. Immediate immunoglobulin E (IgE) and delayed T cell–mediated reactions are the main types of allergic responses. The allergens suspected in an immediate IgE-mediated response are identified through serum IgE-specific antibody or skin testing. For patients with an inhalant allergy, skin or IgE-specific antibody testing is preferred. In patients with food allergies, eliminating the suspected allergenic food from the diet is the initial treatment. If this is ineffective, IgE-specific antibody or skin testing can exclude allergens. An oral food challenge should be performed to confirm the diagnosis. Patients with an anaphylactic reaction to an insect sting should undergo IgE-specific antibody or skin testing. Skin testing for penicillin has a high negative predictive value and can help when penicillin administration is indicated and there are limited alternatives. Testing for other drug allergies has less well-determined sensitivity and specificity, but can guide the diagnosis. Patch testing can help identify the allergen responsible for contact dermatitis.”). Baldo and Chang are analogous art as they are both directed to the same field of endeavor and are both related to allergen diagnostic methods.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the makeup of the allergen panel from Chang into the device from Baldo as Baldo is silent on how the allergy panel is selected, and Chang discloses a suitable method for choosing an allergen panel in an analogous art.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Baldo as applied to claim 13 above, and further in view of Hamann ‘553 (US 20130108553).
Regarding claim 15, Baldo teaches the multi-layer contact patch of claim 13.
However, Baldo does not teach wherein the allergen panel comprises a selected group of allergens according to an exposure profile.
Hamann ‘553 discloses a test for metal allergens. Specifically, Hamann ‘553 teaches wherein the allergen panel comprises a selected group of allergens according to an exposure profile ([0002]: “the instant invention relates to a patch intended in particular for screening the sensitization state of a subject with respect to metal allergens”; [0003]: “Occupational exposure in the metal and construction industries is also a significant proportion of metal allergy reports”). Baldo and Hamann ‘553 are analogous art as they are both directed to the same field of endeavor and are both related to allergen diagnostic patches.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the makeup of the allergen panel from Hamann ‘553 into the device from Baldo as Baldo is silent on how the allergy panel is selected, and Hamann ‘553 discloses a suitable method for choosing an allergen panel in an analogous art.
Regarding claim 16, the Baldo/Hamann ‘553 combination teaches the multi-layer contact patch of claim 15, wherein the exposure profile comprises an industry specific exposure profile (Hamann ‘553, [0002]: “the instant invention relates to a patch intended in particular for screening the sensitization state of a subject with respect to metal allergens”; [0003]: “Occupational exposure in the metal and construction industries is also a significant proportion of metal allergy reports”).
Conclusion
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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