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 .
Response to Amendment
The amendment filed on June 04, 2026 was considered by the examiner. Claims 1-6, 8-12, and 16-20 are pending in the application.
Claim Objections
Claims 9, 11, 16-17, and 19 are objected to because of the following informalities:
in claim 9, line 2: a comma should be inserted after “metabolites”;
in claim 11, line 4: “or allergen” should be “or the allergen”;
in claim 11, line 5: “at least one” should be inserted before “endogenous”;
in claim 16, line 1: “the” should be inserted before “at least one”;
in claim 17, line 4: “inflamatory” should be “inflammatory”; and
in claim 19, line 2: “and” should be deleted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites “sponge phase and any intermediate between these or mixtures thereof” in lines 3-4. However, the usage of “and” and “or” at the end of the claim make the Markush grouping unclear as to which alternatives are required. Amending the recitation to “sponge phase, any intermediate between these, and mixtures thereof” would overcome the present rejection. The claim is being read as such for the purposes of examination.
Claim 19 recites “distearyl-3-trimethylammonium propane and dielaidyl-3-trimethylammonium propane or mixtures thereof.” in lines 3-5. However, the usage of “and” and “or” at the end of the claim make the Markush grouping unclear as to which alternatives are required. Further, it is not clear whether “distearyl-3-trimethylammonium propane” and “dielaidyl-3-trimethylammonium propane” are alternatives individually, or together. Appropriate clarification is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 8-9, 12, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Nielsen et al. (WIPO Publication 97/13528 – cited by Applicant), hereinafter Nielsen, and in view of Tamarkin et al. (US Patent Application Publication 2010/0310476 – cited in prior action), hereinafter Tamarkin, and in view of Saran et al. (“Effect of 4‑week physical exercises on tryptophan, kynurenine and kynurenic acid content in human sweat”, nature portfolio, Scientific Reports, 11:11092, 2021 May 27 – cited in prior action), hereinafter Saran.
Regarding Claim 1, Nielsen teaches pharmaceutical compositions for administration of an active substance through body surfaces, including undamaged skin (see abstract). Nielsen teaches a matrix (abstract, pg. 1 ln. 30 – pg. 2 ln. 3, and claim 1, the composition enclosing the active substance in the liquid crystalline phase, the enclosing would be considered a matrix; abstract, pg. 7 ln. 23-28, pg. 12 ln. 11 – pg. 13 ln. 14, the bioadhesive structure, abstract and pg. 20 ln. 17-20, for usage on the skin, pg. 22 ln. 5-12, the composition may be with a carrier such as pastes, dressings, bandages, and the like, would be considered a patch) for active substances (pg. 3 ln. 11-16, an active substance is one that when administered in an effective amount, has an effect on living cells or organisms) such as pharmaceutical compositions (see generally pg. 15 ln. 1 – pg. 17 ln. 25, such as antivirals, i.e., the ‘clovirs, and antibiotics)
for non-invasive sampling of at least one endogenous substance on a skin surface of an individual (see abstract, pg. 7 ln. 23-28, pg. 12 ln. 11 – pg. 13 ln. 14, the bioadhesive structure/patch, abstract and pg. 20 ln. 17-20, for usage on the skin),
wherein the matrix comprises at least one amphiphile (pg. 4 ln. 3-7 and pg. 9 ln. 24-27, the fatty acid esters, which may include glyceryl monooleate, which is a natural lipid amphiphile, see present application specification pg. 12 ln. 9-18),
wherein the amphiphile, alone or in combination with at least one structurally related amphiphile, forms a non-lamellar liquid crystalline phase (pg. 4 ln. 9-23 and pg. 28 ln. 25-27 the different liquid crystalline phases, the preferred being cubic phase or reverse hexagonal phase, both of which are non-lamellar phases) together with an aqueous polar solvent mixture (pg. 4 ln. 24-34, the liquid of the liquid crystalline phase is suitably water, or any bodily fluid containing water, such as sweat, which are both polar),
wherein the non-lamellar liquid crystalline phase is configured so as to not undergo a structural phase transition during application on the skin (pg. 1 ln. 21-29, the liquid crystalline phase can confer bioadhesion so as to be retained for a prolonged period of time at site of application, which reads upon the claimed recitation of not undergoing a structural phase transition during the application on the skin).
Nielsen teaches that the composition may be utilized at room temperature, appears to be between 20-37 °C (see pg. 33 ln. 10-19 and pg. 43 ln. 20 – pg. 44 ln. 4), and that excipients may be utilized with the composition, such as PEG (see pg. 23 ln. 1-8), but does not specifically teach that said matrix comprising a water activity of at least 0.85 in a temperature range of 20-40 °C and during application.
Tamarkin teaches formulations/carriers for topical administration of formulations, such as antibiotics (see abstract), in which the formulation/carrier is designed for room temperature (see ¶[0181]), in which the carrier and agent are stable when stored at 25 °C (see ¶[0048]), in which the formulation/carrier composition may be waterless, indicating that there is no or substantially no free or unassociated or absorbed water (see ¶[0044], ¶[0248], and ¶[0441]), in which the carrier may comprise a hygroscopic material, such as polyols and/or PEGs, such that the water activity of the carrier may be less than 0.9 Aw, such as a range of about 0.8 to 0.9 Aw (see ¶[0381]-[0382]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the polyols and/or PEGs with the formulation/carrier of Tamarkin with the excipients of Nielsen, such that the composition, and thus matrix, has a water activity of a range of about 0.8 to 0.9 Aw at room temperature (i.e., about 25 °C) because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the composition of Nielsen would inherently have a water activity and Tamarkin teaches one such water activity; and/or (3) such an additive would be useful for a topical treatment modality (see Tamarkin ¶[0382]). Furthermore, as the water activity is present during the liquid crystalline phase for a prolonged period of time at its application site, the water activity would be sustained through application.
Nielsen teaches that the liquid of the liquid crystalline phase may be a bodily fluid, such as sweat (see pg. 4 ln. 24-34); however, the modified Nielsen does not specifically teach that the matrix is configured to extract said at least one endogenous substance on the skin surface of the individual.
Saran teaches about detection of tryptophan (TRP), kynurenine (KYN), and kynurenic acid (KYNA) from human sweat (see abstract), in which sweat was collected from the skin of the participants using a commercial absorbent patch (see pg. 2, § Methods, ¶5 and pg. 5 § Discussion, ¶7), and the sweat was analyzed for the concentrations of the analytes, including the ratios of KYN/TRP and KYNA/KYN, and sodium (see pg. 3, § Methods, ¶7-8), in which such non-invasive analyte measurement may be useful for rehabilitation patients (see abstract, pg. 5 § Discussion, ¶7, pg. 5 § Conclusions and practical implications).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the sweat collection and analyte analysis of Saran with the sweat absorbing patch of the modified Nielsen because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) one of ordinary skill in the art would have recognized that the patch of the modified Nielsen may be utilized as the commercial patch in the modality as described in Saran; and/or (3) the combination patch would reduce costs as compared to requiring multiple patches for medication delivery and sweat collection for analysis; and/or (3) the modality of analyte measuring in Saran may be useful for rehabilitation patients (see Saran abstract, pg. 5 § Discussion, ¶7, pg. 5 § Conclusions and practical implications).
Regarding Claim 2, Nielsen in view of Tamarkin and Saran teaches the device of claim 1 as stated above. Nielsen further teaches the non- lamellar liquid crystalline phase is selected from the group consisting of: cubic phase, hexagonal phase, micellar, sponge phase and any intermediate between these or mixtures thereof (pg. 4 ln. 9-23 and pg. 28 ln. 25-27 the different liquid crystalline phases, the preferred being cubic phase or reverse hexagonal phase).
Regarding Claim 3, Nielsen in view of Tamarkin and Saran teaches the device of claim 1 as stated above. Nielsen further teaches the amphiphile is selected from the group consisting of: natural lipids, synthetic lipids, ionic lipids and surfactants (pg. 4 ln. 3-7 and pg. 9 ln. 24-27, the fatty acid esters, which may include glyceryl monooleate, which is a natural lipid amphiphile, see present application specification pg. 12 ln. 9-18).
Regarding Claim 4, Nielsen in view of Tamarkin and Saran teaches the device of claim 1 as stated above. Nielsen further teaches the amphiphile is selected from the group consisting of: glyceryl monooleate, glyceryl monoelaidate, glyceryl monolinoleate, glyceryl dioleate, dioleyl phosphatidylglycerol, distearyl phosphatidylglycerol, dioleyl phosphatidyl ethanolamine, dioleyl phosphatidylcholine, phytantriol, or mixtures thereof (pg. 4 ln. 3-7 and pg. 9 ln. 24-27, the fatty acid esters, which may include glyceryl monooleate).
Regarding Claim 5, Nielsen in view of Tamarkin and Saran teaches the device of claim 1 as stated above. Nielsen further teaches the matrix further comprises at least one additive selected from the group consisting of: humectant, drug, bioactive agent, irritant and allergen (see generally pg. 15 ln. 1 – pg. 17 ln. 25, the composition for the pharmaceuticals, i.e., drugs, such as antivirals, i.e., the ‘clovirs, and antibiotics).
Regarding Claim 6, Nielsen in view of Tamarkin and Saran teaches the device of claim 1 as stated above. Nielsen further teaches the aqueous polar solvent mixture comprises water or water in combination with a polar co-solvent (pg. 4 ln. 24-34, the liquid of the liquid crystalline phase is suitably water, or any bodily fluid containing water, such as sweat).
Regarding Claim 8, Nielsen in view of Tamarkin and Saran teaches the device of claim 1 as stated above. The modified Nielsen further teaches a method of using the matrix according to claim 1 (see above claim 1 mapping), the method comprising:
i. placing the matrix against an area of the skin surface of the individual (see Nielsen abstract, pg. 7 ln. 23-28, pg. 12 ln. 11 – pg. 13 ln. 14, the bioadhesive structure, abstract and pg. 20 ln. 17-20, for usage on the skin; see Saran pg. 2, § Methods, ¶5 and pg. 5 § Discussion, ¶7, the sweat was collected from the skin of the participants using an absorbent patch);
ii. extracting at least one endogenous substance on the area of the skin surface of the individual (see Nielsen pg. 4 ln. 24-34, the liquid of the liquid crystalline phase is suitably water, or any bodily fluid containing water, such as sweat; see Saran pg. 2, § Methods, ¶5 and pg. 5 § Discussion, ¶7, the sweat was collected from the skin of the participants using an absorbent patch); and
determining a presence of the at least one endogenous substance (see Saran pg. 3, § Methods, ¶7-8, the sweat was analyzed for the concentrations of the analytes, including the ratios of KYN/TRP and KYNA/KYN, and sodium).
Regarding Claim 9, Nielsen in view of Tamarkin and Saran teaches the method of claim 8 as stated above. The modified Nielsen further teaches the at least one endogenous substance is extracted with other endogenous substances or metabolites and the determining step iii comprises estimating a ratio between two of the extracted endogenous substances or between the at least one endogenous substance and the metabolites (see Saran pg. 3, § Methods, ¶7-8, the sweat was analyzed for the concentrations of the analytes, including the ratios of KYN/TRP and KYNA/KYN, and sodium).
Regarding Claim 12, Nielsen in view of Tamarkin and Saran teaches the method of claim 8 as stated above. The modified Nielsen further teaches said at least one endogenous substance is a low molecular weight substance with a molecular weight of up to 1000 Da (see Saran pg. 3, § Methods, ¶7-8, the sweat was analyzed for the concentrations of the analytes, including the ratios of KYN/TRP and KYNA/KYN, and sodium). Note that TRP has a molecular weight of about 204 Da, KYN has a molecular weight of about 208 Da, and KYNA has a molecular weight of about 189 Da.
Regarding Claim 17, Nielsen in view of Tamarkin and Saran teaches the method of claim 8 as stated above. The modified Nielsen further teaches said at least one endogenous substance is associated with inflammatory diseases selected from the group consisting of: seborrheic dermatitis, rosacea, lupus, psoriasis, eczema, ichtyosis, skin cancer, diabetes and inflammatory bowel disease (see Saran pg. 3, § Methods, ¶7-8, the sweat was analyzed for the concentrations of the analytes, including the ratios of KYN/TRP and KYNA/KYN, and sodium). Note, the specification indicates that TRP and KYN may be associated with several diseases, including cancer (see present application specification pg. 35 ln. 7-19).
Claims 1, 8, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Nielsen, and in view of Tamarkin, and in view of Dupont et al. (US Patent Application Publication 2007/0048361 – cited in prior action), hereinafter Dupont.
Regarding Claim 1, Nielsen teaches pharmaceutical compositions for administration of an active substance through body surfaces, including undamaged skin (see abstract). Nielsen teaches a matrix or a patch (abstract, pg. 7 ln. 23-28, pg. 12 ln. 11 – pg. 13 ln. 14, the bioadhesive structure, abstract and pg. 20 ln. 17-20, for usage on the skin, pg. 22 ln. 5-12, the composition may be with a carrier such as pastes, dressings, bandages, and the like, would be considered a patch) comprising said matrix (abstract, pg. 1 ln. 30 – pg. 2 ln. 3, and claim 1, the composition enclosing the active substance in the liquid crystalline phase, the enclosing would be considered a matrix) for active substances (pg. 3 ln. 11-16, an active substance is one that when administered in an effective amount, has an effect on living cells or organisms) such as pharmaceutical compositions (see generally pg. 15 ln. 1 – pg. 17 ln. 25, such as antivirals, i.e., the ‘clovirs, and antibiotics)
for non-invasive sampling of at least one endogenous substance on a skin surface of an individual (see abstract, pg. 7 ln. 23-28, pg. 12 ln. 11 – pg. 13 ln. 14, the bioadhesive structure/patch, abstract and pg. 20 ln. 17-20, for usage on the skin),
wherein the matrix comprises at least one amphiphile (pg. 4 ln. 3-7 and pg. 9 ln. 24-27, the fatty acid esters, which may include glyceryl monooleate, which is a natural lipid amphiphile, see present application specification pg. 12 ln. 9-18),
wherein the amphiphile, alone or in combination with at least one structurally related amphiphile, forms a non-lamellar liquid crystalline phase (pg. 4 ln. 9-23 and pg. 28 ln. 25-27 the different liquid crystalline phases, the preferred being cubic phase or reverse hexagonal phase, both of which are non-lamellar phases) together with an aqueous polar solvent mixture (pg. 4 ln. 24-34, the liquid of the liquid crystalline phase is suitably water, or any bodily fluid containing water, such as sweat, which are both polar),
wherein the non-lamellar liquid crystalline phase is configured so as to not undergo a structural phase transition during application on the skin (pg. 1 ln. 21-29, the liquid crystalline phase can confer bioadhesion so as to be retained for a prolonged period of time at site of application, which reads upon the claimed recitation of not undergoing a structural phase transition during the application on the skin).
Nielsen teaches that the composition may be utilized at room temperature, appears to be between 20-37 °C (see pg. 33 ln. 10-19 and pg. 43 ln. 20 – pg. 44 ln. 4), and that excipients may be utilized with the composition, such as PEG (see pg. 23 ln. 1-8), but does not specifically teach that said matrix comprising a water activity of at least 0.85 in a temperature range of 20-40 °C.
Tamarkin teaches formulations/carriers for topical administration of formulations, such as antibiotics (see abstract), in which the formulation/carrier is designed for room temperature (see ¶[0181]), in which the carrier and agent are stable when stored at 25 °C (see ¶[0048]), in which the formulation/carrier composition may be waterless, indicating that there is no or substantially no free or unassociated or absorbed water (see ¶[0044], ¶[0248], and ¶[0441]), in which the carrier may comprise a hygroscopic material, such as polyols and/or PEGs, such that the water activity of the carrier may be less than 0.9 Aw, such as a range of about 0.8 to 0.9 Aw (see ¶[0381]-[0382]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the polyols and/or PEGs with the formulation/carrier of Tamarkin with the excipients of Nielsen, such that the composition, and thus matrix, has a water activity of a range of about 0.8 to 0.9 Aw at room temperature (i.e., about 25 °C) because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the composition of Nielsen would inherently have a water activity and Tamarkin teaches one such water activity; and/or (3) such an additive would be useful for a topical treatment modality (see Tamarkin ¶[0382]). Furthermore, as the water activity is present during the liquid crystalline phase for a prolonged period of time at its application site, the water activity would be sustained through application.
Nielsen teaches that the liquid of the liquid crystalline phase may be a bodily fluid, such as sweat (see pg. 4 ln. 24-34); however, the modified Nielsen does not specifically teach that the matrix is configured to extract said at least one endogenous substance on the skin surface of the individual.
Dupont teaches a patch comprising a support for adhering at least one biologically active substance (see abstract and Fig. 1), in which the biologically active substance may comprise an allergen to illicit a response of the subject’s skin (see ¶[0006]-[0008], ¶[0041], and ¶[0126]), in which a colored pH indicator may indicate a positive allergic reaction to the biologically active substance (see ¶[0087]-[0088], ¶[0129]). Here, the pH color indicator necessitates a chemical reaction indicating the at least one reactant caused by and indicative of a positive allergic reaction, in which the at least one reactant is the extracted endogenous substance.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the allergy determination modality of Dupont with the sweat absorbing patch of the modified Nielsen because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) one of ordinary skill in the art would have recognized that the patch of the modified Nielsen may be utilized as the patch for housing the biologically active substance as in the modality as described in Dupont; and/or (3) the modified Nielsen requires a biologically active substance and Dupont teaches one such substance; and/or (4) this test would provide beneficial information about allergic reactions that happen in a delayed or semi-delayed manner to a medical professional caring for the subject (see Dupont ¶[0007]).
Regarding Claim 8, Nielsen in view of Tamarkin and Dupont teaches the device of claim 1 as stated above. The modified Nielsen further teaches a method of using the matrix according to claim 1 (see above claim 1 mapping), the method comprising:
i. placing the matrix against an area of the skin surface of the individual (see Nielsen abstract, pg. 7 ln. 23-28, pg. 12 ln. 11 – pg. 13 ln. 14, the bioadhesive structure, abstract and pg. 20 ln. 17-20, for usage on the skin; see Dupont ¶[0006]-[0008], ¶[0041], and ¶[0126], the biologically active substance may comprise an allergen to illicit a response of the subject’s skin);
ii. extracting at least one endogenous substance on the area of the skin surface of the individual (see Nielsen pg. 4 ln. 24-34, the liquid of the liquid crystalline phase is suitably water, or any bodily fluid containing water, such as sweat; see Dupont ¶[0006]-[0008], ¶[0041], and ¶[0126], the biologically active substance may comprise an allergen to illicit a response of the subject’s skin); and
determining a presence of the at least one endogenous substance (see Dupont ¶[0087]-[0088], ¶[0129], the colored pH indicator may indicate a positive allergic reaction to the biologically active substance).
Regarding Claim 10, Nielsen in view of Tamarkin and Dupont teaches the method of claim 8 as stated above. The modified Nielsen further teaches delivering a drug or a bioactive agent, prior to and/or simultaneously to step ii, from the matrix (see Nielsen abstract, pg. 1 ln. 30 – pg. 2 ln. 3, and claim 1, the composition enclosing the active substance in the liquid crystalline phase, the enclosing would be considered a matrix, pg. 3 ln. 11-16, the active substance that, when administered in an effective amount, has an effect on living cells or organisms to the subject; see Dupont ¶[0006]-[0008], ¶[0041], and ¶[0126], the biologically active substance may comprise an allergen to illicit a response of the subject’s skin),
to trigger a response that reflects the presence of the at least one extracted endogenous substance (see Dupont ¶[0087]-[0088], ¶[0129], the colored pH indicator may indicate a positive allergic reaction to the biologically active substance).
Regarding Claim 11, Nielsen in view of Tamarkin and Dupont teaches the method of claim 8 as stated above. The modified Nielsen further teaches delivering an irritant or an allergen, prior to and/or simultaneously to step ii, from the matrix (see Nielsen abstract, pg. 1 ln. 30 – pg. 2 ln. 3, and claim 1, the composition enclosing the active substance in the liquid crystalline phase, the enclosing would be considered a matrix, pg. 3 ln. 11-16, the active substance that, when administered in an effective amount, has an effect on living cells or organisms to the subject; see Dupont ¶[0006]-[0008], ¶[0041], and ¶[0126], the biologically active substance may comprise an allergen to illicit a response of the subject’s skin),
to estimate if said irritant or allergen triggers a response in the skin of the individual, and thus to distinguish between an irritant effect, an allergic effect, or a toxic effect of said endogenous substance on the individual (see Dupont ¶[0087]-[0088], ¶[0129], the colored pH indicator may indicate a positive allergic reaction to the biologically active substance).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Nielsen in view of Tamarkin and Saran as applied to claim 8 above, and in view of Nitzan (US Patent Application Publication 2024/0307293 – cited in prior action), hereinafter Nitzan.
Regarding Claim 16, Nielsen in view of Tamarkin and Saran teaches the method of claim 8 as stated above. The modified Nielsen does not specifically teach that extracting at least one endogenous substance on the area of the skin surface of the individual comprises a use of reverse iontophoresis.
Nitzan teaches methods and systems for controlling electrolyte excretion during sweating (see abstract and Fig. 1), in which 1-2 patches may be applied to the skin of a body part, such as a torse, without penetrating needles, and reverse iontophoresis is performed via electrodes in the patches by applying a small current to the region (see ¶[0050]-[0052]).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the reverse iontophoresis of Nitzan with the sweat absorbing patch of the modified Nielsen because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results; and/or (2) the reverse iontophoresis may enhance the extraction of certain analytes, such as sodium (see Nitzan ¶[0051]); and/or (3) the modified Nielsen teaches to analyze analytes in sweat, including sodium, and Nitzan teaches a modality of enhancing extraction of sodium from sweat.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Nielsen in view of Tamarkin and Saran as applied to claim 8 above, and in view of Zhang et al. (WIPO Publication WO2022/165262), hereinafter Zhang.
Regarding Claim 18, Nielsen in view of Tamarkin and Saran teaches the device of claim 1 as stated above. The modified Nielsen does not specifically teach that the amphiphile is an ionic lipid selected from the group consisting of: anionic lipids, cationic lipids and zwitterionic lipids.
Zhang teaches about various compositions, systems, and methods for delivery cargo to a target cell (see abstract), in which the delivery system may include liquid crystals (see ¶[0612]) and such a system may include a fusogenic polypeptide or membrane fusion moleucule, which may comprise various lipids, including DOTAP (1,2- dioleoyl-3-trimethylammonium-propane) (see ¶[0291]). Note that DOTAP is a cationic lipid (see specification pg. 14 ln. 28-29).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the DOTAP cationic lipid of Zhang with the modified Nielson because (1) it is the application of a known technique to a known device ready for improvement to yield predictable results and/or (2) DOTAP would help to molecules cross cell barriers on the skin, so as to more efficiently extract the at least one endogenous species (see Zhang ¶[0291]).
Regarding Claim 19, Nielsen in view of Tamarkin, Saran, and Zhang teaches the device of claim 18 as stated above. The modified Nielsen further teaches the cationic lipids are selected from the group consisting of: dioleoyl-3-trimethylammonium propane, and dipalmitoyl-3- trimethylammonium propane, dipalmityl-3-trimethylammonium propane, distearyl-3- trimethylammonium propane and dielaidyl-3-trimethylammonium propane or mixtures thereof (see Zhang ¶[0291] the DOTAP cationic lipid).
Regarding Claim 20, Nielsen in view of Tamarkin, Saran, and Zhang teaches the device of claim 18 as stated above. The modified Nielsen further teaches the cationic lipid is dioleoyl-3- trimethylammonium propane (see Zhang ¶[0291] the DOTAP cationic lipid).
Response to Arguments
Applicant’s arguments, objections to the claims
Applicant’s arguments, see pg. 6, filed June 04, 2026, with respect to the objections of claims 8-11 and 16-17 have been fully considered and are persuasive. Therefore, the objections have been withdrawn. However, upon further consideration, new objections are made that were necessitated by Applicant’s amendment filed on June 04, 2026.
Applicant’s arguments, 35 U.S.C. § 112(b)
Applicant’s arguments, see pg. 6-7, filed June 04, 2026, with respect to the rejections of claims 1-6, 8-12, and 16-17 under 35 U.S.C. § 112(b) have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection are made that were necessitated by Applicant’s amendment filed on June 04, 2026.
Applicant’s arguments, 35 U.S.C. § 103
Applicant’s arguments, see pg. 7-14, filed June 04, 2026, with respect to the rejections of claims 1-6, 8-12, and 16-17 under 35 U.S.C. § 103 have been fully considered and are NOT persuasive. Applicant discusses the difference of Nielsen’s drug delivery system to the claimed matrix, and that “One of ordinary skill in the art would not look to a drug delivery system and expect it to function effectively for extraction”. The examiner respectfully disagrees. In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues that, with regard to the combination of Nielsen and Tamarkin, the combination would yield, if anything, predictable results in delivery systems and have nothing in common with an extraction system. The examiner respectfully disagrees. Regardless of whether the combination is directed towards a delivery system or extraction system, at this point in the combination (i.e., Nielsen in view of Tamarkin), teaches a matrix comprising at least one amphiphile, wherein the amphiphile, alone or in combination with at least one structurally related amphiphile, forms a non-lamellar liquid crystalline phase together with an aqueous polar solvent mixture, said matrix comprising a water activity of at least 0.85 in a temperature range of 20-40 C, wherein the non-lamellar liquid crystalline phase is configured to sustain said water activity of at least 0.85 without undergoing a structural phase transition during application on the skin (see above claim 1 mapping). The examiner maintains that this teaches the matrix structurally as currently required in the claim. Therefore, Applicant’s arguments are not persuasive.
Furthermore, Applicant argues that the composition of Nielsen would not inherently have the water activity as taught by Tamarkin. The examiner respectfully disagrees. It was never alleged that Nielsen would inherently have the water activity as taught by Tamarkin. Rather, Nielsen would inherently have a water activity, and Tamarkin teaches one such water activity, that one of ordinary skill in the art before the effective filing date of the claimed invention would have found obvious to use for the water activity in Nielsen. Therefore, Applicant’s arguments are not persuasive.
In addition, Applicant argues that the combination of Nielsen in view of Tamarkin is based on hindsight. In response to Applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant argues that there is no disclosure for the “sweat absorbing patch of the modified Nielsen”. The examiner respectfully disagrees. The matrix as taught by the combination teaches all of the structural elements as required by the claim. The examiner maintains that as all the structural elements are met, the functional aspects (i.e., extraction) would be capable to be performed by such a patch. Therefore, Applicant’s arguments are not persuasive.
Applicant argues that it is “unclear how either of the alleged combination patch would reduce costs as compared to requiring multiple patches for medication delivery and sweat collection for analysis; and/or the modality of analyte measuring in Saran may be useful for rehabilitation patients is relevant to the matter at hand”. The examiner respectfully disagrees. Having one patch would reduce material costs as compared to two. Showing clinical application of the patch/matrix shows why such a combination would have been obvious to one of ordinary skill in the art, which is relevant to the matter at hand. Therefore, Applicant’s arguments are not persuasive.
Applicant argues that the combination patch would be unstable, as compared to the claimed system. The examiner respectfully disagrees. The matrix as taught by the combination teaches all of the structural elements as required by the claim. The examiner maintains that as all the structural elements are met, the stability would also be the same. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the structural requirements for such a stability) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues that the combination of Nielsen and Tamarkin in view of Saran is based on hindsight. In response to Applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant argues that “the recited matrix achieves a genuine synergistic effect. The previously unknown synergistic effect is the result of the unique combination of a non-lamellar structure and its designed stability at high water activity”. The examiner respectfully disagrees. The matrix as taught by the combination teaches all of the structural elements as required by the claim. The examiner maintains that as all the structural elements are met, the stability would also be the same. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the structural requirements for such a stability) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues that Dupont “does not extract an endogenous substance from the skin of the subject, but instead deposits a color indicator, which in some embodiments is a pH indicator, onto the skin which is activated by the allergic reaction”. The examiner respectfully disagrees. In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The matrix as taught by the combination teaches all of the structural elements as required by the claim. The examiner maintains that as all the structural elements are met, the patch would necessarily perform the function of extraction based on the chemical reaction, in the combination of Nielson in view of Tamarkin and Dupont. Therefore, Applicant’s arguments are not persuasive.
The rejections to the dependent claims are maintained by virtue of the rejected independent claims for the reasons as described above. Therefore, Applicant’s arguments are not persuasive and the rejections to the claims under 35 U.S.C. § 103 are maintained.
Conclusion
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.
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/J.D.M./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
