DETAILED ACTION
In application filed on 02/23/2024, Claims 5-6, 8-10 and 12-19 are pending. The claim set submitted on 09/09/2024 is considered because this is the most recent claim set with some preliminary amendments. Claims 5-6, 8-10 and 12-19 are considered in the current office 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/05/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 17 is objected to because of the following informalities:
Claim 17 recites the limitation “the composition” but recited “a pharmaceutical composition” in Claim 16.
Consistent language should be use and for the purpose of expedited prosecution, Examiner interprets “the composition” as “the pharmaceutical composition”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 9-10 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.
Claims 9 recites the limitation "layers 1, 2 or the sum of layers 1 and 2 " .
It is not clear what "layers 1, 2 or the sum of layers 1 and 2 " entails.
Are "layers 1, 2 or the sum of layers 1 and 2” technical terms for the layers of the structure of the “stratum corneum”. Applicant should provide clarification.
For the purpose of expedited prosecution, the limitation "layers 1, 2 or the sum of layers 1 and 2 " is interpreted by the Examiner as "any layers”.
Claim 10 recites the limitation "layers 3, 4 or the sum of layers 3 and 4" .
It is not clear what "layers 3, 4 or the sum of layers 3 and 4" entails.
Are "layers 3, 4 or the sum of layers 3 and 4" technical terms for the structure of the layers of the structure of “stratum corneum”. Applicant should provide clarification.
For the purpose of expedited prosecution, the limitation "layers 3, 4 or the sum of layers 3 and 4" is interpreted by the Examiner as "any layers”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 5-6, 8-10 and 12-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation. All claims are directed to statutory categories, i.e., a method (Claims 5-6, 8-10 and 12-19) (Step 1: YES).
Analysis:
Claim 5: Ineligible.
Step 1:
The claim recites a series of steps or acts, including “method to identify a subject having atopic dermatitis at risk of developing a food allergy”. Thus, the claim is directed to a method, which is one of the statutory categories of invention (Step 1: YES).
Step 2A Prong 1:
Claim 5 recites “b. determining the expression level of one or more proteins selected from the group consisting of Keratin 14 (KRT14), Keratin 5 (KRT5), Keratin 16 (KRT16), and combinations thereof in the skin sample (mental step); and c. comparing the expression level of the one or more proteins in step b to a control sample, wherein a statistically different expression level of the one or more proteins from step b as compared to the expression level of the same one or more proteins in the control sample identifies the subject as being at risk of the subject as being at risk of developing a food allergy, and wherein the control sample is from one or more subjects having atopic dermatitis without having a food allergy. (mental or math step)”.
Therefore, the claim is directed towards an abstract idea, and more specifically to the abstract idea group of a mental/math processes since claim 5 relates to using a mental or math processes to perform the method to identify a subject having atopic dermatitis at risk of developing a food allergy” (Step 2A, Prong 1: Patent Ineligible).
Step 2A, Prong 2:
This judicial exception is not integrated into a practical application.
Once the determination and comparison are done, No further action takes place.
Also the steps of “obtaining a skin sample from the subject, wherein the skin sample is a non-lesional skin sample from the subject” are recited at a high level of generality that it amounts to mere data gathering (insignificant extra-solution activity). See MPEP 2106.05(g).
Step 2B:
Furthermore, the courts have found that limitations adding insignificant extrasolution activity to the judicial exception, such as mere data gathering in conjunction with a law of nature or abstract idea, are limitations found not to be enough to qualify as ‘significantly more’ when recited in a claim with a judicial exception (see the 2014 Interim Guidance on Patent Subject Matter Eligibility of the Federal Register dated December 16, 2014; and MPEP 2106.05(I)(A)). Note that mere data gathering is not significantly more than the abstract idea. See MPEP 2106.05(g).
Here, there are no additional elements which are significantly more than the abstract idea. The steps of “obtaining a skin sample from the subject, wherein the skin sample is a non-lesional skin sample from the subject” appears to be well-understood, routine, and conventional (WURC) in the field of clinical diagnostics, as evidenced by Leung et al. (US20170176455A) in view of Siebold et al. (US20160215344A1). (Step 2B: NO).
Therefore, Claim 5 is ineligible.
Moreover, Claims 6, 8-10 and 12-19 are rejected by virtue of their dependency on Claim 5.
Also, each of the dependent claims 6, 8-10 and 12-19 do not solve the issues of claim 5.
Claims 6, 8 and 14: Ineligible.
Step 2A, Prong One and Prong Two: Claims 6 and 8 further presents an abstract ideas “determining the ratio of esterified o-hydroxy fatty acid sphingosine ceramides (EOS CER) to nonhydroxy fatty acid sphingosine ceramides (NS CER) in the skin sample from the subject; and comparing the ratio of EOS CER to NS CER in the skin sample to a control sample wherein a decreased ratio in the skin sample as compared to the control sample further identifies the subject as being at risk of developing a food allergy” (mental or math step); “wherein the expression of one or more proteins selected from the group consisting of KRT14, KRT5,KRT16, and combinations thereof is significantly increased as compared to the control levels” (mental or math step); and “wherein the expression of one or more proteins selected from the group consisting of KRT14, KRT5,KRT16, and combinations thereof is significantly increased as compared to the control levels (mental or math step)”.
Step 2B: The claims do not recite any elements which are significantly more.
Therefore, Claims 6, 8 and 14 are ineligible.
Claims 9-10, 12-13 and 15-19: Ineligible.
Step 2A, Prong One and Prong Two: Claims 9-10, 12-13 and 15-19 further define the data gathering steps, which appear to be generic and WURC.
Step 2B: The claims do not recite any elements which are significantly more.
Therefore, Claims 9-10, 12-13 and 15-19 are ineligible.
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 5, 8-12 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over by Leung et al. (US20170176455A) in view of Siebold et al. (US20160215344A1).
Regarding Claim 5, Leung teaches a method to identify a subject having atopic dermatitis at risk of developing an allergy (See Abstract… to novel methods for identifying a population of subjects that are at risk for developing of atopic allergic diseases, and to the prevention of these allergic diseases.) comprising:
a. obtaining a skin sample from the subject (See Para 0007…(a) obtaining a skin sample from the subject), wherein the skin sample (See Para 0007… a skin sample from the subject) is a non-lesional skin sample (See Para 0044…on the nonlesional area of the forearm at 2 months) from the subject (See Para 0007…(a) obtaining a skin sample from the subject);
b. determining the expression level of one or more proteins including thymic stromal lymphopoietin (TSLP) in the skin sample (See Para 0007… (b) determining the expression level of thymic stromal lymphopoietin (TSLP) in the skin sample); and
c. comparing the expression level of the one or more proteins in step b to a control sample (See Para 0007…comparing the expression level of TSLP in the skin sample to a control sample), wherein a statistically different expression level of the one or more proteins from step b as compared to the expression level of the same one or more proteins in the control sample identifies the subject as being at risk of the subject as being at risk of developing an allergy (See Para 0007… an increased expression level of TSLP as compared to the control sample identifies the subject as being at risk to develop an allergic disease; See Para 0008… c) comparing the expression level of TSLP in the skin sample to a control sample wherein a statically significant increased expression level of TSLP as compared to the control sample identifies the subject as having an allergic disease), and
wherein the control sample is from one or more subjects having atopic dermatitis without having an allergy (See Para 0041… The control can be matched in one or more characteristics to the subject. In one aspect, the control can be an individual (such as an infant) with no family history of allergy and does not develop an allergic disease such as AD).
While Leung does not expressly teach that the allergy is food allergy, Leung does teach that the allergic disease (allergy) includes food allergy (See Para 0009).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Leung to include food allergy as a type of allergy, as taught by Leung for the benefit of selecting food allergy as the allergic disease (Leung, Para 0009), allowing for the provision of studying approaches to prevent AD as well as other infantile allergic diseases, including use of strategies to improve skin barrier or downregulate the type 2 allergic immune response (Leung, Para 0006).
Modified Leung does not explicitly teach:
b. determining the expression level of one or more proteins selected from the group consisting of Keratin 14 (KRT14), Keratin 5 (KRT5), Keratin 16 (KRT16).
In the analogous art of novel methods to identify and treat subjects having inflammatory asthma subphenotypes, Siebold teaches:
b. determining the expression level of one or more proteins selected from the group consisting of Keratin 14 (KRT14), Keratin 5 (KRT5), Keratin 16 (KRT16) (See Para 0014… the one or more genes that had been determined to be strongly correlated with IL-13 expression is selected from the group consisting, KRT14 KRT16, KRT5, KRT6A,).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Leung to include “determining the expression level of one or more proteins selected from the group consisting of Keratin 14 (KRT14), Keratin 5 (KRT5), Keratin 16 (KRT16)”, as taught by Siebold, for the benefit of having the expression level of the one or more genes that had been determined to be strongly correlated with IL-13 expression is determined by Next-generation based sequencing and transcript quantification (Siebold, Para 0013), allowing for providing an alternative to bronchial brushings would increase the practical utility of such findings especially in children (Siebold, Para 0006).
Regarding Claim 8, the method of claim 5 is obvious over Leung in view of Siebold.
Modified Leung does not teach wherein the expression of one or more proteins selected from the group consisting of KRT14, KRT5,KRT16, and combinations thereof, is significantly increased as compared to the control levels.
In the analogous art of novel methods to identify and treat subjects having inflammatory asthma subphenotypes, Siebold teaches:
wherein the expression of one or more proteins selected from the group consisting of KRT14, KRT5,KRT16, and combinations thereof (See Para 0014… the one or more genes that had been determined to be strongly correlated with IL-13 expression is selected from the group consisting, KRT14 KRT16, KRT5, KRT6A,), is significantly increased as compared to the control levels (See Para 0015…the gene expression level of any of the one or more of the genes from the subject as compared to the control level is altered if the expression level of the one or more genes is over-expressed or under-expressed as compared to the control level).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Leung to include “wherein the expression of one or more proteins selected from the group consisting of KRT14, KRT5,KRT16, and combinations thereof, is significantly increased as compared to the control levels”, as taught by Siebold, for the benefit of having the expression level of the one or more genes that had been determined to be strongly correlated with IL-13 expression is determined by Next-generation based sequencing and transcript quantification (Siebold, Para 0013), allowing for providing an alternative to bronchial brushings would increase the practical utility of such findings especially in children (Siebold, Para 0006).
Regarding Claim 9, the method of claim 5 is obvious over Leung in view of Siebold.
Leung teaches wherein the skin sample (See Para 0007… (a) obtaining a skin sample from the subject; See Para 0026…The term “sample” or “patient sample” or “subject sample” or “test sample” can be used generally to refer to a sample of any type which contains products that are to be evaluated by the present methods, including but not limited to, a skin sample including a skin epidermal sample) comprises layers 1 (See Para 0025…horny layer), 2 or the sum of layers 1 and 2 (This limitations “ 2 or the sum of layers 1 and 2”are viewed as optional ) from the stratum corneum of the subject (See Para 0025…was previously determined that TSLP expressed in the horny layer of stratum corneum, like IL-4, IL-13, IL-17, IL-22, IL-25, IL-31 and IL-33, promotes Th2 type inflammation, and downregulates filaggrin expression (Sano Y, et al. Thymic stromal lymphopoietin expression is increased in the horny layer of patients with atopic dermatitis).
Regarding Claim 10, the method of claim 5 is obvious over Leung in view of Siebold.
Leung teaches wherein the skin sample ((See Para 0007… (a) obtaining a skin sample from the subject; See Para 0026…The term “sample” or “patient sample” or “subject sample” or “test sample” can be used generally to refer to a sample of any type which contains products that are to be evaluated by the present methods, including but not limited to, a skin sample including a skin epidermal sample)) comprises layers 3 (See Para 0025…horny layer), 4 or the sum of layers 3 and 4 (This limitations “ 2 or the sum of layers 1 and 2”are viewed as optional ) from the stratum corneum of the subject (See Para 0025…was previously determined that TSLP expressed in the horny layer of stratum corneum, like IL-4, IL-13, IL-17, IL-22, IL-25, IL-31 and IL-33, promotes Th2 type inflammation, and downregulates filaggrin expression (Sano Y, et al. Thymic stromal lymphopoietin expression is increased in the horny layer of patients with atopic dermatitis).
Regarding Claim 12, the method of claim 5 is obvious over Leung in view of Siebold.
Leung teaches wherein the skin sample (See Para 0007… (a) obtaining a skin sample from the subject;) is obtained by a skin tape stripping method (See Para 0026…Cells can be obtained, for example, by a tape stripping method (also referred to as “skin tapping”)).
Regarding Claim 16, the method of claim 5 is obvious over Leung in view of Siebold.
Leung wherein the subject identified as at risk of having an allergic disease is administered (See Para 0032… In one aspect of the invention, the subject identified as being at risk and/or predisposed to develop allergic disease or a subject having been diagnosed as having an allergic disease, but is asymptomatic, is administered a therapeutic) a pharmaceutical composition (See Para 0011…(See Para 0011… the pharmaceutical composition is administered to the subject by an administration route selected from the group consisting topical, oral, and subcutaneous) comprising a compound selected from the group consisting of corticosteroids, leukotriene antagonists, anti- cytokine antibodies, anti-cytokine receptor antibodies, anti-IgE antibody, anti- interleukin 14 (IL14) antibodies, anti-interleukin 13 (IL13) antibodies, JAK kinase inhibitors, JAK/STAT inhibitors, antibiotics, a phosphodiesterase inhibitor, a cream comprising filaggrin or components thereof, ceramide rich emollients, and combinations thereof (See Para 0037… the subjects can be treated by administration of one or more compounds including but not limited, corticosteroids, leukotriene antagonists, anti-cytokine antibodies, anti-cytokine receptor antibodies, anti-IgE antibody, JAK kinase inhibitors, antibiotics, a phosphodiesterase inhibitor, and combinations thereof.).
While Leung does not expressly teach that the allergy is food allergy, Leung does teach that the allergic disease (allergy) includes food allergy (See Para 0009).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Leung to include food allergy as a type of allergy, as taught by Leung for the benefit of selecting food allergy as the allergic disease (Leung, Para 0009), allowing for the provision of studying approaches to prevent AD as well as other infantile allergic diseases, including use of strategies to improve skin barrier or downregulate the type 2 allergic immune response (Leung, Para 0006).
Regarding Claim 17, the method of claim 5 is obvious over Leung in view of Siebold.
Leung teaches wherein the composition is administered by an administration route selected from the group consisting of local administration, topical administration, and injection (See Para 0011… the pharmaceutical composition is administered to the subject by an administration route selected from the group consisting topical, oral, and subcutaneous.).
Regarding Claim 18, the method of claim 5 is obvious over Leung in view of Siebold.
Modified Leung teaches wherein the food allergy is selected from the group consisting of a peanut allergy, a milk allergy, an egg allergy, a wheat allergy, a tree nut allergy and a combination thereof (See Para 0003… These strong infantile IgE antibody responses to food proteins can be considered as markers for atopic reactivity in general, since they have been demonstrated to be predictors of subsequent sensitization to other food proteins (peanuts, tree nuts) or aeroallergens from the indoor or outdoor environment.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Leung to include that the food allergy is selected from the group consisting of a peanut allergy, a milk allergy, an egg allergy, a wheat allergy, a tree nut allergy and a combination thereof, as taught by Leung for the benefit of disclosing that strong infantile IgE antibody responses to food proteins can be considered as markers for atopic reactivity in general, since they have been demonstrated to be predictors of subsequent sensitization to other food proteins (peanuts, tree nuts) or aeroallergens from the indoor or outdoor environment, (Leung, Para 0003), allowing for the provision of studying approaches to prevent AD as well as other infantile allergic diseases, including use of strategies to improve skin barrier or downregulate the type 2 allergic immune response (Leung, Para 0006).
Regarding Claim 19, the method of claim 5 is obvious over Leung in view of Siebold.
Leung teaches wherein the subject is less than 18 years of age (See Para 0038… one aspect of the invention, the subject in human, and in a preferable aspect the human is an infant human. Infant as used herein is defined as up to two years (24 months) of age).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Leung et al. (US20170176455A) in view of Siebold et al. (US20160215344A1) as applied to claim 12 above, and further in view of Ishikawa et al. (US20190302133A1, submitted in IDS on 07/05/2024)
Regarding Claim 6, the method of claim 5 is obvious over Leung in view of Siebold.
The combination of Lueng and Siebold does not teach: determining the ratio of esterified o-hydroxy fatty acid sphingosine ceramides (EOS CER) to nonhydroxy fatty acid sphingosine ceramides (NS CER) in the skin sample from the subject; and comparing the ratio of EOS CER to NS CER in the skin sample to a control sample wherein a decreased ratio in the skin sample as compared to the control sample further identifies the subject as being at risk of developing a food allergy.
In the analogous art of a method of evaluating the health of skin, Ishikawa teaches:
determining the ratio of esterified o-hydroxy fatty acid sphingosine ceramides (EOS CER) to nonhydroxy fatty acid sphingosine ceramides (NS CER) in the skin sample from the subject (Abstract…calculating the content ratio of the quantitatively determined content of the ceramide component A to the quantitatively determined content of the ceramide component B; … evaluating the health of the skin of the test subject from the calculated content ratio;wherein the ceramide component A is selected from the group consisting of a non-hydroxyacyl-phytosphingosine ceramide, a non-hydroxyacyl-6-hydroxysphingosine ceramide component, an esterified ω-hydroxyacyl-6-hydroxysphingosine ceramide component and an esterified ω-hydroxyacyl-phytosphingosine ceramide component; and the ceramide component B is selected from the group consisting of a non-hydroxyacyl-sphingosine ceramide and an α-hydroxyacyl-sphingosine ceramide component; Further See Para 0194… EOS: esterified w-hydroxyacyl-sphingosine ceramide (referring to a ceramide having a structure in which a sphingosine and an esterified ω-hydroxy fatty acid are bonded by an amide bond.)See Para 0013… a non-hydroxyacyl-sphingosine ceramide (hereinafter, also simply referred to as “NS”) )); and
comparing the ratio of EOS CER to NS CER in the skin sample to a control sample wherein a decreased ratio in the skin sample as compared to the control sample (See Claim 12… The method according to claim 1, wherein in a case in which the average value of the ceramide content ratio of the healthy group is higher than the average value of the ceramide content ratio of the non-healthy group,) further identifies the subject as being at risk of developing a food allergy (See Claim 12… when the ceramide content ratio thus calculated is lower than or equal to the lower limit of the value range of the ceramide content ratio characterizing the healthy group or the upper limit of the value range of the ceramide content ratio characterizing the non-healthy group, the test subject is evaluated as “having a possibility of being non-healthy” or “having a high possibility of being non-healthy”;).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Leung and Siebold to include “determining the ratio of esterified o-hydroxy fatty acid sphingosine ceramides (EOS CER) to nonhydroxy fatty acid sphingosine ceramides (NS CER) in the skin sample from the subject; and comparing the ratio of EOS CER to NS CER in the skin sample to a control sample wherein a decreased ratio in the skin sample as compared to the control sample further identifies the subject as being at risk of developing a food allergy”, as taught by Ishikawa, for the benefit of evaluating health of skin, and an apparatus for evaluating health of skin (Ishikawa, Para 0001), allowing for the provision of the ability to analyze lipids of the stratum corneum, particularly ceramides, in detail, and thereby obtain information about the types and amounts of ceramides present in the stratum corneum, can be expected to make it possible to scientifically evaluate whether the skin is healthy (Ishikawa, Para 0004).
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Leung et al. (US20170176455A) in view of Siebold et al. (US20160215344A1) as applied to claim 12 above, and further in view of Benson et al. (US20050221334A1).
Regarding Claim 13, the method of claim 12 is obvious over Leung in view of Siebold.
Leung teaches wherein:
a. applying an adhesive tape to a target area of the skin of the subject in a manner sufficient (See Para 0013… (a) adhering a skin tape to the skin of the subject..) to isolate an epidermal sample (See Claim 5… skin sample is an epidermal skin sample.) adhering to the adhesive tape (See Para 0013… (b) removing the skin tape from the skin of the subject; (c) extracting the TSLP protein and/or RNA from the removed skin tape; See Para 0015… In any of the methods or uses described herein the skin sample is an epidermal skin sample), wherein the epidermal sample comprises cells from the stratum corneum of the subject (Examiner submits under BRI that an epidermal sample from the stratum corneum contains dead, flattened skin cells called corneocytes that form the body's outer protective shield.).
The combination of Leung and Siebold does not teach that the tape comprises a rubber adhesive; and
b. extracting the epidermal sample comprising the one or more proteins and/or one or more filaggrin breakdown products adhering to the adhesive tape with a cell scraper comprising thermoplastic elastomer material in a solvent of about 5% to about 30% alcohol in water.
In the analogous art of non-invasive methods for detecting, monitoring, and diagnosing skin disease and pathological skin states such as irritated skin and psoriasis. The methods include using tape stripping to analyze expression in epidermal samples, of one or more skin markers. In illustrative examples, the tape stripping is performed using pliable tape that has a rubber adhesive, Benson teaches that the tape comprises a rubber adhesive (See Abstract… the tape stripping is performed using pliable tape that has a rubber adhesive.); and
b. extracting the epidermal sample comprising the one or more proteins (See Para 0009…isolating or detecting a nucleic acid molecule from an epidermal sample of a psoriatic lesion of a human subject; See Para 0059…the nucleic acid can encode a protein such as CD2, TNFα, or IFNγ) adhering to the adhesive tape (See Para 0012…applying an adhesive tape to a target area of skin and to an unaffected area of the skin, in a manner sufficient to isolate an epidermal sample adhering to the adhesive tape, wherein the epidermal samples comprise nucleic acid molecules) with a cell scraper (referred to as film [Para 0039]) comprising thermoplastic elastomer material (See Para 0039…the film can be made of any of many possible polymers…the tape contains a rubber adhesive on a 3.0 mil polyurethane film. For example the film can be a polyurethane film such as skin harvesting tape) in a solvent of about 5% to about 30% alcohol in water (See Para 0040…alcohol).
The limitation “and/or one or more filaggrin breakdown products” is viewed as optional and thus not required by the claim.
Further , regarding the limitation of “about 5% to about 30% alcohol in water”, MPEP § 2144.05, Part II, Subpart B holds that a particular parameter that is recognized as a result effective variable (“a variable that achieves a recognized result”) would be one, but not the only motivation for a person of ordinary skill in the art to experiment to reach another workable product or process. In the application of a concentration of alcohol in water for skin applications, the selection of optimal experimental conditions including alcohol percentage in water dictates the use of the solvent towards any of disinfection, sanitization and general skin care. Thus, the “about 5% to about 30% alcohol in water” is a result effective variable.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Leung and Siebold to include “that the tape comprises a rubber adhesive; and b. extracting the epidermal sample comprising the one or more proteins and/or one or more filaggrin breakdown products adhering to the adhesive tape with a cell scraper comprising thermoplastic elastomer material in a solvent of about 5% to about 30% alcohol in water, as taught by Benson for the benefit of detecting expression of genes in the skin, including applying an adhesive tape to a target area of the skin in a manner sufficient to isolate an epidermal sample adhering to the adhesive tape, wherein the epidermal sample comprises nucleic acid molecules, wherein the tape comprises a rubber adhesive, and wherein the tape is pliable (Benson, Para 0035) and for skin site stripped to be cleaned, for example using an antiseptic cleanser such as alcohol (Benson, Para 0040), allowing for the benefit of providing detection methods for skin diseases that are effective for diagnosing many skin diseases, and detects diseases before clinical manifestation (Benson, Para 0002).
Regarding Claim 14, the method of claim 13 is obvious over Leung in view of Siebold and further in view of Benson.
Leung teaches
determining the expression level of the one or more proteins in the epidermal sample (See Para 0007… (b) determining the expression level of thymic stromal lymphopoietin (TSLP) in the skin sample; See Para 0015…the skin sample is an epidermal skin sample).
The claimed “and/or the one or more filaggrin breakdown products” is interpreted as optional, thus not required by the claim.
Regarding Claim 15, the method of claim 13 is obvious over Leung in view of Siebold and further in view of Benson.
Leung teaches 4 or fewer skin tapes are applied to the subject (See Para 0013…(a) adhering a skin tape to the skin of the subject).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OYELEYE ALEXANDER ALABI whose telephone number is (571)272-1678. The examiner can normally be reached on M-F 7:30am-5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached on (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/OYELEYE ALEXANDER ALABI/ Examiner, Art Unit 1797
Prosecution Insights