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 § 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.
Claim(s) 1-5, 7-8, 11-12, 15, and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lane et al (US 2010/0022910) (“Lane”).
Regarding Claim 1, Lane teaches a cutaneous skin patch (Abstract, Figs. 1A-1C, [0034]-[0038] disposable patch 20), comprising:
a backing having an adhesive surface that adheres to skin of a human user (Figs. 1A-1C, [0034], [0036] disposable patch 20 has a backing / body 22 having an adhesive surface / adhesive 32 that adheres to a skin of a human user);
one or more wells containing ingredients (Figs. 1A-1C, [0034]-[0035], [0039] one or more wells containing ingredients / a plurality of small blisters or packets 26 thereon containing allergens of various types, including food allergies, suspended either in a solvent or freeze dried); and
one or more landmarks (Figs 1A-1C, [0036]-[0038] one or more landmarks / marking materials 28 that identify allergens and how the patch was oriented when applied).
Regarding Claim 2, Lane teaches the cutaneous skin patch of claim 1, wherein application of the patch to the skin causes the skin to be marked with the one or more landmarks ([0036] landmarks / marking material 28 will mark the skin of the user with identifying information).
Regarding Claim 3, Lane teaches the cutaneous skin patch of claim 2, wherein application of the patch to the skin further causes contact between the ingredients and the skin for skin sensitivity testing (Abstract, [0034] application of the system is for skin sensitivity testing for contained allergens, [0040]-[0043] where application of the patch to the skin causes the contact between the ingredients and the skin through the use of an applicator).
Regarding Claim 4, Lane teaches the cutaneous skin patch of claim 3, wherein the marked skin aids interpretation of results of the skin sensitivity testing (See Claims 2 and 3 Rejection, the marked skin aids may include the identity of packets 26).
Regarding Claim 5, Lane teaches the cutaneous skin patch of claim 1, wherein the ingredients are mixed with a base substance (See Claim 1 Rejection, solvent / base substance is mixed with ingredients / allergens within packet either at the time of application or prior to application).
Regarding Claim 7, Lane teaches the cutaneous skin patch of claim 1, wherein the one or more landmarks cause the skin to be marked in a manner that indicates an orientation of the patch on the skin ([0036]-[0038] “The marking further serves as a reference as to the location of the overall patch as applied.”).
Regarding Claim 8, Lane teaches the cutaneous skin patch of claim 1, wherein the one or more landmarks cause the skin to be marked in a manner that indicates a location of at least one of the one or more wells ([0036] “Specifically referring to FIG. 1B and on the bottom surface 27 of the patch 20, adjacent at least one and preferably each packet 26 is a marking material 28 that is transferable to the patient skin. The marking material 28 can be used to indicate the identity of the allergen or control reagent contained in each packet 26.”).
Regarding Claim 11, Lane teaches the cutaneous skin patch of claim 1, wherein the patch is applied to the skin by the user ([0042]).
Regarding Claim 12, Lane teaches the cutaneous skin patch of claim 1, wherein the patch further comprises a removable liner that seals the one or more wells ([0036] removable liner / removable cover 30 seals the bottom surface of the backing / body 22 meaning it seals the wells).
Regarding Claim 15, Lane teaches a method of manufacturing a cutaneous skin patch, comprising:
shaping a backing having an adhesive surface that adheres to skin of a human user;
configuring one or more wells on the backing;
incorporating one or more landmarks onto the backing; and
populating the one or more wells with ingredients mixed with a base (Figs. 1A-1C, [0034]-[0039] a patch 20 is shaped with a backing / body 22 with an adhesive surface / adhesive 32 that adheres to a skin of a human user, the backing / body 22 is configured with one or more wells / packets 26, the backing / body 22 incorporates one or more landmarks / marking materials 28 on a bottom surface, and the wells / packets 26 are populated with allergens of various types, including food allergies, suspended either in a solvent or freeze dried).
Regarding Claim 17, Lane teaches the method of claim 15, further comprising: printing on a reverse side of the backing one or more of:
instructions for using the patch;
an aesthetic design;
a brand;
a logo; and
a code (See Claim 15 Rejection, [0036] marking materials 28 are on the reverse side / bottom surface 27 of the backing / body 22 and may be printed as a code for deciphering through the use of alphanumerical symbols or as a serial number code for the particular test administered)
Regarding Claim 18, Lane teaches the method of claim 15, wherein the one or more landmarks, when the patch is affixed to the skin, cause the skin to be marked to indicate an orientation of the patch ([0036]-[0038] “The marking further serves as a reference as to the location of the overall patch as applied.”).
Regarding Claim 19, Lane teaches the method of claim 15, wherein the one or more landmarks, when the patch is affixed to the skin, mark the skin to indicate locations of the one or more wells ([0036] “Specifically referring to FIG. 1B and on the bottom surface 27 of the patch 20, adjacent at least one and preferably each packet 26 is a marking material 28 that is transferable to the patient skin. The marking material 28 can be used to indicate the identity of the allergen or control reagent contained in each packet 26.”).
Regarding Claim 20, Lane teaches the method of claim 15, wherein the one or more landmarks include at least one of:
a temporary tattoo;
a stencil for manually marking the skin; and
means for transferring a semi-permanent marking substance to the skin ([0036] “The marking material 28 may be an ink, paint, or comprised of other materials that transfer onto the skin upon close contact. The marking material 28 may be water-proof or sweat-proof to ensure legibility after the predetermined time for the skin to be exposed to the allergen has passed. The marking material 28 should be temporary in nature.”).
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(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lane in view of Elliott (US 2019/0110737).
Regarding Claim 6, while Lane teaches the cutaneous skin patch of claim 1, Lane fails teach wherein each of the one or more wells comprises a foam frame that surrounds the ingredient and at least partially defines the well.
However Elliott teaches a multiple well test patch array (Abstract) comprising one or more wells with ingredients (Fig. 11, [0029]-[0030], [0039] haptens/allergens are loaded into chambers that will placed against the skin for testing), and each of the one or more wells comprises a foam frame that surrounds the ingredient and at least partially defines the well (Fig. 11, [0039] a cross-section of the testing patch is shown where a test chamber 1108 / well comprises a flexible carrier lattice comprising a foam frame / polyethylene foam core 1105 that defines the test chamber 1108 / well and will surround any loaded allergens / ingredients placed within if an absorbent material layer 1103 is not used, [0030] which may be desirable depending on the chosen allergen).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to structure the substrate of Lane’s patch with the foam frame taught by Elliott as a known material to provide desired flexibility for the substrate of Lane (Lane [0034]) while also providing a standardized construction for the allergen wells across applications of the inventions, ensuring consistency across results.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lane in view of Gillman et al (US 2015/0025412) (“Gillman”) as noted in Applicant IDS dated 5/28/2024.
Regarding Claim 9, while Lane teaches the cutaneous skin patch of claim 1, Lane fails to teach further comprising: at least one well containing a marking substance for marking the skin.
However Gillman teaches an allergy testing system (Abstract) wherein an allergy test may have the bottom surface of wells applied with ink to provide a pre-inked circular marking of puncture site ([0054]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further apply a marking substance as taught by Gillman with the wells of Lane as a way to provide a more exact delivery puncture point with which to compare the change in skin characteristics.
Regarding Claim 10, while Lane teaches the cutaneous skin patch of claim 1, Lane fails to teach wherein the one or more landmarks include a stencil through which the skin is manually marked.
However Gillman teaches an allergy testing system (Abstract) wherein an allergy test may have tested substances labeled or patch placement outlined by the use of a stencil ([0053]-[0055]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further apply a stencil as taught by Gillman with the allergy testing patch of Lane as a stencil can provide a more exact location of the delivery site (e.g. a puncture site indicator by the stencil) and thus a more exact comparison for the change in skin characteristics.
Claim(s) 13 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lane in view of Faarbaek et al (US 2008/0275327) (“Faarbaek”) as evidenced by Danell (US 2017/0285006).
Regarding Claim 13, while Lane teaches the cutaneous skin patch of claim 12, and Lane teaches utilizing marking materials that are waterproof or water-resistant (See Claims 1 and 12 Rejections), Lane fails to teach wherein one or more of the backing and the liner are waterproof or water-resistant.
However Faarbaek teaches an adhesive patch device (Abstract, Fig. 1) where prior to application of the patch, the skin-facing side is protected by a polyethylene film line ([0115] where polyethylene film is known in the art as water resistant as evidenced by Danell [0020]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to set the liner of Lane as water-resistant polyethylene film as taught by Faarbaek as a standardized material for a release linear, enabling consistency across applications of the invention, with the water-resistant properties protecting the adhesive bottom of Lane.
Regarding Claim 16, while Lane teaches the method of claim 15, and Lane teaches the method further comprising: sealing the patch with a liner ([0036] removable liner / removable cover 30 seals the bottom surface of the backing / body 22 meaning it seals the wells), and Lane teaches utilizing marking materials that are waterproof or water-resistant (See Claim 15 Rejection), Lane fails to teach the liner is a waterproof or water-resistant liner.
However Faarbaek teaches an adhesive patch device (Abstract, Fig. 1) where prior to application of the patch, the skin-facing side is protected by a polyethylene film line ([0115] where polyethylene film is known in the art as water resistant as evidenced by Danell [0020]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to set the liner of Lane as water-resistant polyethylene film as taught by Faarbaek as a standardized material for a release linear, enabling consistency across applications of the invention, with the water-resistant properties protecting the adhesive bottom of Lane.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lane in view of Schoendorfer (US 5,438,984) as evidenced by Nelson et al (US 2017/0290693) (“Nelson”).
Regarding Claim 14, while Lane teaches the cutaneous skin patch of claim 12, Lane fails to teach the patch further comprising a heat-resistant and moisture-resistant container surrounding the backing and the liner.
However Schoendorfer teaches a medical dermal patch (Abstract) where the patch may be packaged with a heat-resistant and moisture-resistant container surrounding the backing and the liner (Col. 9, L. 51-63, the dermal patch may be packaged in metallic foil that acts as a vapor barrier where metallic foils are known for being heat-resistant as evidenced by Nelson [0260]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to package the dermal patch of Lane with a metallic foil as taught by Schoendorfer to protect the patch from an external environment that can degrade adhesive properties or the allergens themselves by moisture penetration.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
Prosecution Insights