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 .
Response to Amendment
2. According to the Amendment, filed 08 January 2026, the status of the claims is as follows:
Claims 1, 5, 6, and 22 are currently amended;
Claim 21 is previously presented;
Claims 2-4 and 7 are as originally filed;
Claims 8-11, 13-16, and 18-20 are withdrawn; and
Claims 12 and 17 are cancelled.
Response to Arguments
3. Applicant’s arguments, see Remarks, pp. 9-11, filed 03 March 2025, with respect to the rejection of claims 1-5 and 21 under 35 U.S.C. 103 as being unpatentable over Iverson, U.S. Patent Application Publication No. 2001/0024783 A1 (“Iversen”), in view of Chang, U.S. Patent Application No. 2008/0274908 A1 (“Chang”), and further in view of Benson, U.S. Patent Application Publication No. 2005/0221334 A1 (“Benson”), the rejection of claim 6 under 35 U.S.C. 103 as being unpatentable over Iversen in view of Benson, and further in view of Chang, as applied to claims 5, and further in view of Sangha et al., U.S. Patent Application Publication No. 2003/0113906 A1 (“Sangha”), and the rejection of claim 7 under 35 U.S.C. 103 as being unpatentable over Iversen in view of Benson, and further in view of Chang, as applied to claim 1, and further in view of Borkowski, U.S. Patent No. 6,447,463 B1 (“Borkowski”), have been fully considered, and are persuasive in view of the Amendment, filed 08 January 2026. The rejection of claims 1-5 and 21 has been withdrawn.
Claim Rejections - 35 USC § 103
4. 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.
5. 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.
6. Claims 1-5, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Iverson, U.S. Patent Application Publication No. 2001/0024783 A1 (“Iversen”), in view of Chang, U.S. Patent Application No. 2008/0274908 A1 (“Chang”), further in view of Benson, U.S. Patent Application Publication No. 2005/0221334 A1 (“Benson”), and further in view of Quattrone et al., EP 2395338 A1 (“Quattrone”).
As to Claim 1, Iversen teaches the following:
A method for non-invasive collection and analysis of a skin sample using an adhesive skin sample collection kit (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 method comprising:
receiving the 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]),
wherein the adhesive skin sample collection kit 120 comprises … [a] skin sample (“dermal material”, not labeled) adhered to an adhesive matrix (“tacky polymer type adhesive”) of [a] adhesive tape (“adhesive backing”) 134 (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
quantifying the expression levels of one or more target genes in a portion of 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]),
wherein the portion of the skin sample comprises less than about 6 milligrams 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. Where the sample is obtained from a skin region (see below), the sample "volume" is an amount of skin removed by an adhesive from a skin region having an area typically between 1-25 mm.sup.2.” in para. [0186]. This teaching overlaps with the claimed range.).
wherein the skin sample is from a subject having or suspected of having [cancer] (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 claim 9).
In the alternative that Iversen is found to not teach “wherein the portion of the skin sample comprises less than about 6 milligrams of cellular material”, Benson teaches the following:
a portion of a skin sample comprises less than about 6 milligrams of cellular material (see “For microarray expression analysis, approximately 0.1 to 1 milligram, typically 1 to 10 nanograms of RNA are isolated from an epidermal sample, for example obtained using a tape stripping method disclosed herein.” in para. [0083]).
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 skin sample (see “Where the sample is obtained from a skin region (see below), the sample "volume" is an amount of skin removed by an adhesive from a skin region having an area typically between 1-25 mm.sup.2.” in para. [0186]) to have “0.1 to 1 milligram” of cellular material (“RNA”), as taught by Benson because such quantity is within the scope of the prior art teaching for the amount of a skin sample using tape stripping methods to provide the same predictable result, i.e. providing sufficient amount of cellular material for analysis. Furthermore, both Iversen (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 Benson (see “The invention relates generally to non-invasive diagnostics methods and more specifically to methods for isolating and analyzing nucleic acids from skin samples.” in para. [0001]) are in the same field of endeavor.
Iversen in view of Benson does not explicitly teach the following:
wherein the skin sample is from a subject having or suspected of having melanoma.
However, Chang teaches the following:
a skin sample is from a subject having or suspected of having melanoma (see “The non-invasive methods of the invention involve applying an adhesive tape to a target area of skin in a manner sufficient to isolate a sample adhering to the adhesive tape, wherein the sample includes nucleic acid molecules or proteins. Typically, at least one nucleic acid molecule or protein whose expression is informative of melanoma is detected in the sample.” in para. [0016]).
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 skin sample to be from a subject having or suspected of having melanoma, as taught by Chang, because melanoma is a type of cancer, where a simple modification of analyzing at least one nucleic acid molecule or protein, as taught by Chang, would yield predictable results, i.e. detection of a type of cancer in the sample.
Iversen in view of Benson, and further in view of Chang does not explicitly teach the following:
wherein the adhesive skin sample collection kit comprises a placement area panel including a region designated for placement of an adhesive tape removed from a peelable release panel of the adhesive skin sample collection kit.
However, Quattrone teaches the following:
an adhesive skin sample collection kit (“a device for collecting skin cells, adapted for transport and preservation and for the subsequent extraction of the DNA contained in the drawn sample”, not labeled) (see figs. 1B and para. [0012]]; and see “Optionally, the device can be part of a kit which also comprises a bag, preferably impermeable and sealable, where the device itself is inserted and housed. The sample collected by means of the device and thus housed can be easily transported or archived.” in para. [0037]) comprises a placement area panel (“sheet”) 7 including a region (“internal face”) 107 designated for placement of an adhesive tape (“adhesive film”) 2 removed from a peelable release panel (“adhesive portion”) 7a of the adhesive skin sample collection kit (see “In the embodiment 1, the device is a support sheet 7 having a line of demarcation along the symmetry axis for dividing the support itself in two symmetrical halves. The flat sheet 7 comprises an internal face 107 and an external face 207. The internal face 107 comprises an adhesive portion 7a and an anti-adhesive portion 7b. The device comprises a protective film 3 to cover the adhesive portion 7a, a protective membrane 8 to cover the anti-adhesive portion 7b and a protective membrane 9 to cover the external face 207.” in para. [0012]; see “The adhesive portion 7a comprises an adhesive film 2.” in para. [0030]; and see “One alternative applicable to all the described embodiments provides for the possibility of detaching the adhesive film 2, 21, 33 from the adhesive portion 7a, 27a, 33. In this embodiment, a bi-adhesive film will be used, selected in such a manner that it has greater adhesive strength on the side in contact with the support than the adhesive strength present on the side to be used for the sample collection. The materials composing the adhesive and the support were selected so as to allow the operator to detach the adhesive from the support during the analysis step but to prevent the adhesive from detaching from the support during the sample collection step. In this embodiment, the adhesive film 2, 21, 33 can in turn be constituted by one or more portions which can be separated, as shown for example for the embodiment of figure 2. In particular, it can comprise from 1 to 10 adhesive strips, preferably 6 adhesive strips arranged in a contiguous manner on the support so as to form the total adhesive surface.” in para. [0030]).
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 skin sample collection kit (“applicator”) 120, to include a placement area panel (“sheet”) 7 including a region (“internal face”) 107 designated for placement of an adhesive tape (“adhesive film”) 2 removed from a peelable release panel (“adhesive portion”) 7a of the adhesive skin sample collection kit (“a device for collecting skin cells, adapted for transport and preservation and for the subsequent extraction of the DNA contained in the drawn sample”, not labeled), as taught by Quattrone, in order to provide the advantage of “The sample collected by means of the device and thus housed can be easily transported or archived” (see Quattrone, para. [0037]).
As to Claim 2, Iversen teaches the following:
where the portion of 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.).
As to Claim 3, Iversen teaches the following:
where the adhesive tape 134 comprises a plurality of adhesive tapes (“array of regions”) 130 (“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 4, Iversen teaches the following:
where the skin sample comprises 1 picogram to 500 micrograms of cellular material per adhesive tape (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 5, Iversen teaches the following:
wherein the adhesive skin sample collection kit comprises a tri-fold skin sample collector (see the three columns or rows of “regions 130” in fig. 11. The limitation does not define the phrase “tri-fold”, and the phrase is merely a label of the structure. Thus, the three columns or rows of “regions 130” would satisfy the claimed language, based on broadest reasonable interpretation.).
As to Claim 21, Iversen teaches the following:
wherein the one or more target genes are selected from the group consisting of C6orf218, preferentially expressed antigen in melanoma (PRAME) IL-6, IL-8 IL-17A, IL-17C, UL-17F, IL-17RA, PL-17RC, OL-21, 9-22, IL-23A, IL-24, IL-26, TNF-α, TNF RSFIA, S100A7, S100A9, CCL20, CXCL1, CXCL5, LON2, DEFB4A, and combinations thereof (see para. [0151]-[0154]).
As to Claim 22, Quattrone teaches the following:
wherein the adhesive tape (“adhesive film”) 2 is one of a plurality of adhesive tapes (see “In this embodiment, the adhesive film 2, 21, 33 can in turn be constituted by one or more portions which can be separated, as shown for example for the embodiment of figure 2. In particular, it can comprise from 1 to 10 adhesive strips, preferably 6 adhesive strips arranged in a contiguous manner on the support so as to form the total adhesive surface.” in para. [0030]) releasable from the peelable release panel (“sheet”) 7,
wherein the placement area panel 7 comprises a removable liner (“protective film”) 3 (see “The sheet 7, once the protective film 3 has been removed, the sample on the adhesive portion 7a collected and the protection membrane 8 present on the anti-adhesive portion 7b removed, is folded along the line of symmetry 5, such that the adhesive portion 7a containing the drawn sample is situated in contact with the anti-adhesive portion 7b and thus remains protected in the transport and storage steps.” in para. [0017]),
wherein the region is a plurality of regions (“adhesive zones”) 27a, each of the plurality of regions 27a is designated for placement of a used adhesive tape (“adhesive film”) 2 (see para. [0030], and “Alternatively, the embodiment depicted in Figure 3 provides that the sheet 27 comprises a double series of low relief zones 25a, 25b, 25c, 25d, 25e, 25f to which two adhesive portions 27a correspond.” in para. [0020]), and
wherein the adhesive matrix (“adhesive portion”) 7a (see “The device comprises a protective film 3 to cover the adhesive portion 7a, …” in para. [0012], and see “The adhesive portion 7a comprises an adhesive film 2.” in para. [0013]) is configured to adhere to an effective amount of the skin sample (see “From the skin samples collected with the device described herein, it is possible to extract DNA and/or RNA with known methods, obtaining a DNA and a RNA of a quality such that they can be used in any one of the currently available methods for DNA and RNA analysis, such as sequencing with Sanger method or with Next Generation Sequencing method, hybridization with probe systems of various types, including microarrays, assays of single nucleotide polymorphism (SNP) executed with various methods, mutation assays, methylation assays, possibly following amplification by means of Polymerase Chain Reaction (PCR) or Reverse Transcription (RT-PCR).” in para. [0045]).
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 skin sample collection kit (“applicator”) 120, to include a placement area panel (“sheet”) 7 including a region (“internal face”) 107 designated for placement of an adhesive tape (“adhesive film”) 2 removed from a peelable release panel (“adhesive portion”) 7a of the adhesive skin sample collection kit (“a device for collecting skin cells, adapted for transport and preservation and for the subsequent extraction of the DNA contained in the drawn sample”, not labeled), as taught by Quattrone, in order to provide the advantage of “The sample collected by means of the device and thus housed can be easily transported or archived” (see Quattrone, para. [0037]).
7. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Iversen in view of Chang, further in view of Benson, and further in view of Quattrone, as applied to claims 5 above, and further in view of Sangha et al., U.S. Patent Application Publication No. 2003/0113906 A1 (“Sangha”).
As to Claim 6, Iversen in view of Benson, and further in view of Chang, teaches the subject matter of claim 5 above. Iversen in view of Benson, and further in view of Chang, does not teach the following:
wherein the tri-fold skin sample collector comprises an area for labeling patient information, wherein the patient information comprises identification of a disease state, likelihood of treatment success for a given disease state, identification of progression of a disease state, or identification of a disease stage.
However, Sangha teaches the following:
an area (“subject information area”) 172 for labeling patient information (see “Device 170 is comprised of subject information area 172 where relevant information about the subject from whom the DNA sample is being collected may be recorded.” in para. [0057], and fig. 17),
wherein the patient information comprises identification of a disease state, likelihood of treatment success for a given disease state, identification of progression of a disease state, or identification of a disease stage (matter of intended use of the area).
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 skin sample collection kit to include the “subject information area 172” in order to provide proper and safe handling of the biological sample in a clinical environment.
8. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Iversen in view of Chang, further in view of Benson, and further in view of Quattrone, as applied to claim 1 above, and further in view of Borkowski, U.S. Patent No. 6,447,463 B1 (“Borkowski”).
As to Claim 7, Iversen in view of Benson, and further in view of Chang, teaches the subject matter of claim 1 above. Iversen in view of Benson, and further in view of Chang, does not teach the following:
wherein the adhesive skin sample collection kit comprises a lab requisition form, and wherein the lab requisition form is labeled with a unique barcode assigned to a patient sample.
However, Borkowski teaches the following:
an adhesive skin sample collection kit (“Diagnostic Kit box”) 1 comprises a lab requisition form (“data form”, not labeled) (see “The kit can also include a data form to be filled out by the user. The form can request information concerning how long the skin has been infected, personal data on the customer, color of skin, other description of the skin (i.e. flaky, friable, etc.), any previous conditions, age, sex, insurance information, whether skin legion is causing pain, whether skin is infected, etc. Other information is also within the scope of the invention.” in col. 4, ll. 9-16), and wherein the lab requisition form is labeled with a unique barcode assigned to a patient sample (see “The adhesive tape preferably has a translucent window 3, bar code 4, corresponding to bar code number 5 and rectangular piece of glossy paper 6 attached to the back of a free end of adhesive tape. Alternatively or additionally, the bar code and/or bar code number can also be provided on the specimen bag.” in col. 3, ll. 34-39)
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 skin sample collection kit to include the “data form” and “bar code”, as taught by Borkowski, in order to provide proper and safe handling of the biological sample in a clinical environment.
Conclusion
9. 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.
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 02/03/2026