DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 16 January 2026 has been entered.
Response to Amendment
3. According to the Amendment, filed 16 January 2026, the status of the claims is as follows:
Claims 1 and 8 are currently amended;
Claims 2, 9, 11, 19, and 21 are previously presented;
Claims 3, 4, 12, and 13 are withdrawn;
Claims 5-7, 10, 14-17, and 20 are as originally filed;
Claim 22 is new; and
Claim 18 is cancelled.
Response to Arguments
4. Applicant’s arguments, see Remarks, pp. 5-6, filed 16 January 2026, with respect to the rejection of claims 1, 2, 6-11, and 15-21 under 35 U.S.C. 103 as being unpatentable over Iversen et al., U.S. Patent Application Publication No. 2001/0024783 A1 (“Iversen”), in view of Watson et al., U.S. Patent No. 7,129,389 B1 (“Watson”), have been fully considered, and are persuasive in view of the Amendment, filed 16 January 2026. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection, which was necessitated by amendment, is discussed below.
5. Applicant’s arguments, see Remarks, p. 6, filed 16 January 2026, with respect to the rejection of claims 5 and 14 under 35 U.S.C. 103 as being unpatentable over Iversen in view of Watson, as applied to claims 1 and 8, respectively, and further in view of Ritsuro et al., Japanese Patent No. 2001-161697 A (“Ritsuro”), have been fully considered, and are persuasive in view of the Amendment, filed 25 August 2025. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection, which was necessitated by amendment, is discussed below.
Claim Rejections - 35 USC § 103
6. 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.
7. 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.
8. Claims 1, 2, 6-11, and 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over Iversen et al., U.S. Patent Application Publication No. 2001/0024783 A1 (“Iversen”), in view of Watson et al., U.S. Patent No. 7,129,389 B1 (“Watson”), and further in view of Vogt, U.S. Patent Application Publication No. 2003/0108896 A1 (“Vogt”).
As to Claim 1, Iversen teaches the following:
A system for non-invasive collection and analysis of a skin sample (see “The present invention relates to a non-invasive method for detecting the presence of RNA target sequences in vivo, and to arrays, kits and antibodies useful in practicing the method.” in para. [0002], and figs. 11-14), the system comprising:
an adhesive skin sample collection kit (“applicator”) 120 see “FIG. 11 shows an applicator 120 for use in administering a plurality of oligomers to a skin region of a patient.” in para. [0241]) comprising at least one adhesive tape (“adhesive patch”) 122,
wherein the at least one adhesive tape 122 comprises a collection area (“collector layer”) 132 comprising an adhesive matrix (“adhesive backing”) 134 on a surface (see “To collect sample, a collector layer 132 having an adhesive backing 134 is placed over patch 122, adhesive side down, bringing the adhesive into contact with the skin in the areas of patch openings, as seen in FIG. 13. The adhesive, which is typically a tacky polymer type adhesive is effective to bond to the upper surface layer of the skin. Removal of the collector layer from the patch is thus effective to collect cells, dermal debris, and any heteroduplex contained in the upper dermal layer. The collector layer now forms an array of adhesive regions, each having dermal material collected through one of the patch openings.” in para. [0243]) and …,
wherein the adhesive matrix 134 comprises a polymer (see “The adhesive, which is typically a tacky polymer type adhesive is effective to bond to the upper surface layer of the skin.” in para. [0243]), and
wherein the adhesive matrix 134 is configured to adhere to an effective amount of the skin sample (“dermal material”, not labeled) for quantifying expression levels of one or more target genes in the skin sample (see “Heteroduplex present is a body sample, such as urine, saliva, blood, hair, or a skin-cell sample, may be assayed by solid-phase or fluid-phase assay methods. In general, a solid-phase reaction involves first binding heteroduplex analyte to a solid-phase support, e.g., particles or a polymer or test-strip substrate, and detecting the presence/amount of heteroduplex bound to the support.” in para. [0191]).
Iverson does not teach the following:
the adhesive tape including a handling area extending from a periphery of the collection area, …
However, Watson teaches the following:
an adhesive tape (“spacer”) 14 including a handling area (“pull tab”) 24 extending from a periphery of the collection area (“patch”) 10 (see “To make removal easier, the patch may further include pull tab 24 that protrude from the spacer 14. The pull tab 24 is preferably unitary with the spacer 14. The pull tab 24 may or may not include adhesive on the inner face 17. Thus, the practitioner can easily grab the loose pull tab 24 to remove the patch from the patient's skin.” in col. 4, ll. 29-35, and fig. 1), …
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Iversen’s adhesive tape (“spacer”) 14 to include Watson’s handling area (“pull tab”) 24 in order to allow a practitioner to “… easily grab the loose pull tab 24 to remove the patch from the patient's skin” (see Watson, col. 4, ll. 29-35).
Iverson in view of Watson does not teach the following:
the one or more target genes associated with a skin condition.
However, Vogt teaches the following:
one or more target genes associated with a skin condition (see “In one aspect, the present invention provides a non-invasive method for detecting malignant melanoma in a skin sample of a subject. The method includes analyzing expression in skin sample of one or more melanoma skin markers. The melanoma skin markers include IL-1 RI, endothelin-2, ephrin-A5, IGF Binding Protein 7, HLA-A0202 heavy chain, Activin A (.beta.A subunit), TNF RII, SPC4, and CNTF R.alpha.. Expression of the melanoma skin markers is related to melanoma. In certain preferred embodiments, the skin sample includes nucleic acids, and is a human skin sample from a lesion suspected of being melanoma.” in para. [0023]).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Iversen’s one or more target genes to be associated with a skin condition, as taught by Vogt, in order to detect markers for early and late stage malignant melanoma using the non-invasive sampling system and methods of Iversen by analyzing the mRNAs disclosed by Vogt. Furthermore, Iversen and Vogt are analogous art as both uses skin-stripping procedures to obtain a skin sample (see Iversen, para. [0241]; and see Vogt, para. [0011]).
As to Claim 2, Watson teaches the following:
wherein the handling area 24 comprises a tab (“pull tab”) (see “To make removal easier, the patch may further include pull tab 24 that protrude from the spacer 14. The pull tab 24 is preferably unitary with the spacer 14. The pull tab 24 may or may not include adhesive on the inner face 17. Thus, the practitioner can easily grab the loose pull tab 24 to remove the patch from the patient's skin.” in col. 4, ll. 29-35, and fig. 1).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Iversen’s adhesive tape (“spacer”) 14 to include Watson’s handling area (“pull tab”) 24 in order to allow a practitioner to “… easily grab the loose pull tab 24 to remove the patch from the patient's skin” (see Watson, col. 4, ll. 29-35).
As to Claim 6, Iversen teaches the following:
wherein the effective amount of the skin sample comprises from about 1 picogram to about 1 gram of cellular material (see “The amount of sample collected is typically in the 0.1 to 10 ml range. preferably about 1 ml of less.” in para. [0186]. This volumetric range converts to approximately 1 mg to 100 mg in weight, depending on the density of the material, and thus, within the claimed range. The amount of material would be divided by the amount the “array of regions, such as region 130”.).
As to Claim 7, Iversen teaches the following:
wherein the effective amount of the skin sample comprises less than about 500 micrograms (see “The amount of sample collected is typically in the 0.1 to 10 ml range. preferably about 1 ml of less.” in para. [0186]. This volumetric range converts to approximately 1 mg to 100 mg in weight, depending on the density of the material, and thus, within the claimed range.).
As to Claim 8, Iversen teaches the following:
A method for analyzing a skin sample (see “The present invention relates to a non-invasive method for detecting the presence of RNA target sequences in vivo, and to arrays, kits and antibodies useful in practicing the method.” in para. [0002], and figs. 11-14) comprising:
receiving a skin sample (“dermal material”, not labeled) adhered to an adhesive matrix (“adhesive backing”) 134 of a collection area (“collector layer”) 132 of an adhesive tape (“adhesive patch”) 122 (see “To collect sample, a collector layer 132 having an adhesive backing 134 is placed over patch 122, adhesive side down, bringing the adhesive into contact with the skin in the areas of patch openings, as seen in FIG. 13. The adhesive, which is typically a tacky polymer type adhesive is effective to bond to the upper surface layer of the skin. Removal of the collector layer from the patch is thus effective to collect cells, dermal debris, and any heteroduplex contained in the upper dermal layer. The collector layer now forms an array of adhesive regions, each having dermal material collected through one of the patch openings.” in para. [0243]), … the adhesive matrix 134 including a polymer (see “The adhesive, which is typically a tacky polymer type adhesive is effective to bond to the upper surface layer of the skin.” in para. [0243]);
quantifying expression levels of one or more target genes in the skin sample (see “Heteroduplex present is a body sample, such as urine, saliva, blood, hair, or a skin-cell sample, may be assayed by solid-phase or fluid-phase assay methods. In general, a solid-phase reaction involves first binding heteroduplex analyte to a solid-phase support, e.g., particles or a polymer or test-strip substrate, and detecting the presence/amount of heteroduplex bound to the support.” in para. [0191]), …; and
determining at least one of a diagnosis or a treatment of a skin disease using the expression levels (see “For use in detecting the presence or levels of an mRNA which is diagnostic of a given biochemical or pathological condition or a predisposition to such condition, such as (i) pregnancy, (ii) heart disease, (iii) alcoholism, and (iv) cancer, the target RNA is an mRNA encoding a protein diagnostic of the selected condition.” in para. [0042]; and see “For use in detecting changes in expression of a target gene in response to a therapeutic agent in the subject, the target RNA is mRNA produced by expression of the target gene, the steps of the invention are performed at a selected times before and administration of the therapeutic agent, and the levels of heteroduplex before and after such administration are compared.” in para. [0041]).
Iverson does not teach the following:
the adhesive tape including a handling area extending from a periphery of the collection area, …
However, Watson teaches the following:
an adhesive tape (“spacer”) 14 including a handling area (“pull tab”) 24 extending from a periphery of the collection area (“patch”) 10 (see “To make removal easier, the patch may further include pull tab 24 that protrude from the spacer 14. The pull tab 24 is preferably unitary with the spacer 14. The pull tab 24 may or may not include adhesive on the inner face 17. Thus, the practitioner can easily grab the loose pull tab 24 to remove the patch from the patient's skin.” in col. 4, ll. 29-35, and fig. 1).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Iversen’s adhesive tape (“spacer”) 14 to include Watson’s handling area (“pull tab”) 24 in order to allow a practitioner to “… easily grab the loose pull tab 24 to remove the patch from the patient's skin” (see Watson, col. 4, ll. 29-35).
Iverson in view of Watson does not teach the following:
the one or more target genes associated with a skin condition.
However, Vogt teaches the following:
one or more target genes associated with a skin condition (see “In one aspect, the present invention provides a non-invasive method for detecting malignant melanoma in a skin sample of a subject. The method includes analyzing expression in skin sample of one or more melanoma skin markers. The melanoma skin markers include IL-1 RI, endothelin-2, ephrin-A5, IGF Binding Protein 7, HLA-A0202 heavy chain, Activin A (.beta.A subunit), TNF RII, SPC4, and CNTF R.alpha.. Expression of the melanoma skin markers is related to melanoma. In certain preferred embodiments, the skin sample includes nucleic acids, and is a human skin sample from a lesion suspected of being melanoma.” in para. [0023]).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Iversen’s one or more target genes to be associated with a skin condition, as taught by Vogt, in order to detect markers for early and late stage malignant melanoma using the non-invasive sampling system and methods of Iversen by analyzing the mRNAs disclosed by Vogt. Furthermore, Iversen and Vogt are analogous art as both uses skin-stripping procedures to obtain a skin sample (see Iversen, para. [0241]; and see Vogt, para. [0011]).
As to Claim 9, Watson teaches the following:
wherein the handling area 24 comprises a tab (“pull tab”) (see “To make removal easier, the patch may further include pull tab 24 that protrude from the spacer 14. The pull tab 24 is preferably unitary with the spacer 14. The pull tab 24 may or may not include adhesive on the inner face 17. Thus, the practitioner can easily grab the loose pull tab 24 to remove the patch from the patient's skin.” in col. 4, ll. 29-35, and fig. 1).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Iversen’s adhesive tape (“spacer”) 14 to include Watson’s handling area (“pull tab”) 24 in order to allow a practitioner to “… easily grab the loose pull tab 24 to remove the patch from the patient's skin” (see Watson, col. 4, ll. 29-35).
As to Claim 10, Watson teaches the following:
wherein the tab is sized for avoiding unnecessary contact with the adhesive matrix of the collection area 10 when handling the adhesive tape 14 (see “To make removal easier, the patch may further include pull tab 24 that protrude from the spacer 14. The pull tab 24 is preferably unitary with the spacer 14. The pull tab 24 may or may not include adhesive on the inner face 17. Thus, the practitioner can easily grab the loose pull tab 24 to remove the patch from the patient's skin.” in col. 4, ll. 29-35, and fig. 1).
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Iversen’s adhesive tape (“spacer”) 14 to include Watson’s handling area (“pull tab”) 24 in order to allow a practitioner to “… easily grab the loose pull tab 24 to remove the patch from the patient's skin” (see Watson, col. 4, ll. 29-35).
As to Claim 11, Iversen teaches the following:
wherein the collection area 132 is transparent such that a skin sampling area of a subject is visible after application of the adhesive tape 122 to a skin surface (see the transparency shown in fig. 11).
As to Claim 15, Iversen teaches the following:
wherein the adhesive tape does not comprise latex, silicone, or both (“adhesive patch 122” does not contain these materials, see para. [0241]).
As to Claim 16, Iversen teaches the following:
wherein the adhesive tape is sufficiently flexible to conform to a shape a lesion of a skin surface (see “The period of administration, i.e., the period during which layer 128 is held in contact with the skin, is typically 1-4 hours, after which the layer is removed from the patch, which is retained on the patient skin surface.” in para. [0242]).
As to Claim 17, Iversen teaches the following:
wherein the adhesive tape is about 5 to about 100 mm in length (the claimed size is within the scope of Iversen’s disclosure, see “FIG. 11 shows an applicator 120 for use in administering a plurality of oligomers to a skin region of a patient. The applicator includes an adhesive patch 122 that is applied to the patient's skin area.” in para. [0241]. In the alternative, Examiner takes Official Notice that the claimed range is within the length of adhesive tape applied to skin as known in the art).
As to Claim 18, Iversen teaches the following:
wherein the adhesive tape is about 5 to about 40 mm in length (the claimed size is within the scope of Iversen’s disclosure, see “FIG. 11 shows an applicator 120 for use in administering a plurality of oligomers to a skin region of a patient. The applicator includes an adhesive patch 122 that is applied to the patient's skin area.” in para. [0241]. In the alternative, Examiner takes Official Notice that the claimed range is within the length of adhesive tape applied to skin as known in the art).
As to Claim 19, Iversen teaches the following:
wherein the adhesive tape is one of a plurality of adhesive tapes (“oligomer array layer 128 having an array of regions, such as region 130”, where the regions have “an array of openings, such as openings 124, 126”) 124, 126 (see “The applicator patch has an array of openings, such as openings 124, 126 through which oligomer will be delivered to a selected skin region and through which heteroduplex will be collected. Carried over the applicator patch is an oligomer array layer 128 having an array of regions, such as region 130 in registry with corresponding openings in the applicator patch.” in para. [0241]).
As to Claim 20, Iversen teaches the following:
wherein the skin sample comprises an effective amount of the skin sample, the effective amount of the skin sample comprising from about 1 picogram to about 1 gram of cellular material (see “The amount of sample collected is typically in the 0.1 to 10 ml range. preferably about 1 ml of less.” in para. [0186]. This volumetric range converts to approximately 1 mg to 100 mg in weight, depending on the density of the material, and thus, within the claimed range. The amount of material would be divided by the amount the “array of regions, such as region 130”.).
As to Claim 21, Iversen teaches the following:
wherein the skin sample comprises less than about 500 micrograms of cellular material (see “The amount of sample collected is typically in the 0.1 to 10 ml range. preferably about 1 ml of less.” in para. [0186]. This volumetric range converts to approximately 1 mg to 100 mg in weight, depending on the density of the material, and thus, within the claimed range. The amount of material would be divided by the amount the “array of regions, such as region 130”.).
As to Claim 22, Iversen teaches the following:
wherein the one or more target genes are selected from a group consisting of C6orf218, preferentially expressed antigen in melanoma (PRAME), IL-6, IL- 8, IL-17A, IL-17C, IL-17F, IL-17RA, IL-17RC, IL-21, IL-22, IL-23A, IL-24, IL-26, TNF-α, TNF RSF1A, S100A7, S100A9, CCL20, CXCL1, CXCL5, LCN2, DEFB4A, and a combination thereof (see “In a preferred embodiment, the method includes analyzing expression in the skin sample by measuring expression levels of IL-1 RI, endothelin-2, ephrin-A5, IGF Binding Protein 7, HLA-A0202 heavy chain, Activin A (.beta.A subunit), TNF RII, SPC4, and CNTF R.alpha. mRNAs. Expression levels of the IL-1 RI, endothelin-2, and ephrin-A5 genes are related to early stage melanoma, and expression levels of the genes for IGF Binding Protein 7, HLA-A0202 heavy chain, Activin A (.beta.A subunit), TNF RII, SPC4, and CNTF R.alpha. are related to late stage melanoma. More particularly, an increase in the expression levels of IGF Binding Protein 7, HLA-A0202 heavy chain, Activin A (.beta.A subunit), TNF RII, SPC4, and CNTF R.alpha. are related to late stage melanoma. Furthermore, an increase in the expression levels of endothelin-2, and ephrin-A5 genes are related to early stage melanoma. Finally, a decrease in levels of IL-1 RI are related to early stage melanoma. The method can include the combination of all of the melanoma skin markers, or all of the early stage melanoma skin markers, or all of the late-stage melanoma skin markers, weighted according to F-power in a multivariate analysis, to increase the accuracy of the method.” in para. [0025]).
9. Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Iversen in view of Watson, and further in view of Vogt, as applied to claims 1 and 8, respectively, above, and further in view of Ritsuro et al., Japanese Patent No. 2001-161697 A (“Ritsuro”) (see English Translation of Ritsuro).
As to Claims 5 and 14, Iversen in view of Watson, and further in view of Vogt teaches the subject matter of claims 1 and 8, respectively, above. Iversen in view of Watson, and further in view of Vogt, does not teach the following:
wherein the polymer comprises a styrene-isoprene-styrene (SIS) linear block copolymer compound.
However, Ritsuor teaches the following:
a polymer comprising a styrene-isoprene-styrene (SIS) linear block copolymer compound (see “As the gripping tape 5, a 3 × 15 cm film made of polyvinyl chloride was used, and the lower surface thereof was coated with a rubber adhesive mainly composed of a styrene-isoprene-styrene copolymer.”, English Translation of para. [0040])
Thus, it would have been obvious for one of ordinary skill in the art at the time the present application was effectively filed to modify Iversen’s polymer to include “styrene-isoprene-styrene copolymer”, as taught by Ritsuor, in order to “… provide a new skin collecting tool which enables skin epidermal cells to be collected without pain or bleeding, without leaving any trace or pigmentation” (see English Translation of Ritsuor, para. [0012]). Furthermore, both Iversen and Ritsuor are directed to using adhesive tape for collecting skin (see Iversen, para. [0241]; and see Ritsuor, para. [0001]).
Conclusion
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 02/20/2026