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 .
Election/Restrictions
Applicant’s election without traverse of FLG wild type genotype in the reply filed on 05/18/2026 is acknowledged.
Claims 1-10 are under examination.
Claim Objections
Claim 7 is objected to because of the following informalities: the claim recites skin treatment regimen, ingredient and/or composition in lines 4, 5, and 7. This grammatically incorrect, there should be a comma after ingredient. 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 1-10 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.
Claim 1 recites the limitation "the biomarker” in line 5 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites observing the expression of S100A8/A9 but does not recite a biomarker, only recites gene names in a ratio. It is unclear if the biomarker is S100A8, S100A9 or another biomarker. It is unclear what biomarker level is being measured for the standard.
Claim 1, 6, 7 and 10 recites “S100A8/A9”. The claim requires observing the expression of S100A8/A9 on a skin area of an infant. It is unclear what is encompassed by “S100A8/A9”. It is not clear if the claim requires observing expression of S100A8 and S100A9 separately or as a ratio or as a complex. The specification does not define S100A8/A9 and it is unclear what expression is being observed for the claimed invention. One of ordinary skill in the art would not know the metes and bounds of the claimed invention and would not be reasonably apprised of infringing on the claimed invention.
Claim 1 recites determining the propensity of an infant to develop atopic dermatitis wherein an increase in the expression as compared to the determined standard indicates propensity of infant to develop atopic dermatitis. It is unclear what “the expression” encompasses. It is unclear if the expression is the expression of S100A8, S100A9, a biomarker or some other expression. The claim is indefinite because the metes and bounds are unclear because one of ordinary skill in the art would not be reasonably apprised of what expression is required in order to indicate an infant developing atopic dermatitis.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation a skin treatment regimen, ingredient or composition to treat atopic dermatitis, and the claim also recites skin treatment regimen, ingredient and/or composition which is the narrower statement of the limitation. The preamble recites the treatment in the alterative however the step of measuring and applying recite the treatment as a combination. The claim are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 6 and claim 10 require observing expression of S100A8/A9 alone or in combination with other biomarkers on the skin surface of the infant if the infant is determined to have the FLG wildtype genotype. Claim 6 and claim 10 depend from claim 1 and 7, respectively. Both claim 1 and claim 7 require measuring the level of S100A8/A9 of skin of an infant. It is unclear when claim 6 and 10 require measuring the level of S100A8/A9. Claim 6 and claim 10 require measuring S100A8/A9 alone or in combination with other biomarkers if the infant is determined to have the FLG wildtype genotype, however claim 1 and 7 require that S100A8/A9 expression is observed. If the FLG wild type genotype is determined it is unclear what is required. Does the claim require an additional measurement of S100A8/A9, some other unstated measurement or is the order steps 6 and 10 different from the order of the independent claims? It is unclear how the observing expression step of claim 6 and 10 are related to the initial measurement of S100A8/A9. It is unclear how claim 6 and claim 10 further limit the step of measuring level of S100A8/A9 and the metes and bounds of the claim are indefinite.
Claim 7 recites the limitation "the no treatment control” in the last line of the claim. There is insufficient antecedent basis for these limitations in the claims. The claim does not recite or require any treatment control and it is unclear what is the treatment control.
Claim 8 recites the limitation "the face skin” in line 1 of the claim. Claim 9 recites the limitation “the extremity skin” in line 1 of the claim. There is insufficient antecedent basis for these limitations in the claims. Claim 8 and claim 9 depend from claim 7 and claim 7 does not recite face skin or extremity skin. Claim 7 only recites an area of skin.
Claims 2-6 depend from claim 1. Claims 8-10 depend from claim 7. These claims are indefinite for the reasons applied to claim 1 and claim 7, respectively.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6 and 10 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 and claim 10 require observing expression of S100A8/A9 alone or in combination with other biomarkers on the skin surface of the infant if the infant is determined to have the FLG wildtype genotype. Claim 6 and claim 10 depend from claim 1 and 7, respectively. Both claim 1 and claim 7 require measuring the level of S100A8/A9 of skin of an infant. It is unclear how claims 6 and claim 10 further limit claims 1 and 7 when the claims require measuring the level of S100A8/A9. Claim 6 and claim 10 require measuring S100A8/A9 alone or in combination with other biomarkers if the infant is determined to have the FLG wildtype genotype, however claim 1 and 7 require that S100A8/A9 expression is observed. If the FLG wild type genotype is determined its unclear what is required. Does the claim require an additional measurement of S100A8/A9 and how does this further limit the initial measurement of S100A8/A9. It is unclear how claim 6 and claim 10 further limit the step of measuring level of S100A8/A9.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea and law of nature without significantly more.
The claims recite an abstract idea that is a mental process step. Claim 1 recites the step of “observing” the expression, “comparing” the expression, and “determining” the propensity of an infant to develop atopic dermatitis, wherein an increase in the expression as compared to the determined standard indicates propensity of the infant to develop atopic dermatitis. Claim 6 recites “observing” mutation status and “observing” expression if the infant is determined to have the FLG wild type genotype. Claim 7 recites wherein the skin treatment regimen, ingredient and/or composition is beneficial to the skin if the level of S100A8/A9 is “less than or equal to” the no treatment control. . Claim 10 recites if the infant “is determined” to have the FLG wild type genotype. The recitation of observing, comparing, determining, is determined and is beneficial if the level is less than or equal to encompass mental process steps which could be practiced in the mind. The practitioner necessarily needs to perform a comparison in order to determine that there is an elevated expression level in claim 1 and 7. For example the claims encompasses embodiments in which a practitioner evaluates a subject’s expression to ascertain that the expression level is elevated and indicative of atopic dermatitis or wherein the treatment is beneficial to the skin.
The claims are additionally directed to a law of nature. Claim 1 recites a method of predicting a propensity of an infant to develop atopic dermatitis. Claim 7 recites a method of evaluating the efficacy of a treatment. Claim 1 recite measuring an increased level of S100A8/A9 determines propensity to develop atopic dermatitis. Claim 7 recites a decrease in expression determines beneficial treatment. The claims recite a natural phenomenon which is a natural principle: an asserted correlation between elevated expression level and atopic dermatitis and decreased levels in response to treatment. This conclusion is supported by the recited purposed of the claimed method as set forth in the preamble of claim 1 and 7 and the wherein clauses of claim 1 and 7.
This judicial exception is not integrated into a practical application because the steps recited in the claims in addition to the judicial exceptions are data gathering steps that do not apply or integrate the judicial exceptions in any way. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps in addition to the judicial exception are data gathering steps recited at a high level of generality employing techniques that were well-established, routine and conventional at the time of the invention. Here, the claims include steps of expression of S100A8, S100A9 and mutation status of FLG genotype in skin samples. Prior to the invention, Grzanka (Experimental Dermatology, 2012, 21, 184-188) teaches expression analysis of S100A8 and S100A9 in subjects with atopic dermatitis before and after treatment. Carson (2017, cited on IDS) and Leung (US2020/0113508 A1) teach analysis of atopic dermatitis in skin samples from infants. This evidences that these steps were conventional at the time of the invention.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional steps and elements are recited at a high degree of generality and are all routine, well understood and conventional in the prior art.
Claim 3-5 and 8-9 further limit the sample, thus is a field of use limitation and does not amount to significantly more.
Claims 6 and 10 further require analysis of mutation status of FLG. The mutation status is identified via a mental process and thus only limits the judicial exceptions.
While claim 7-10 encompass a step of applying a skin treatment regimen, ingredient or composition to the skin for a period of time this is not integrated to the judicial exceptions. The step of applying the treatment is not integrated to the natural law or mental process. This step occurs regardless of the judicial exceptions.
There is no combination of elements in this step that distinguishes it from well-understood, routine and conventional data gathering activity engaged in by scientists prior to applicant’s invention and at the time the application was filed. Many cited prior art references in this record demonstrate that these techniques were conventional at the time of the invention. Thus the prior art and specification demonstrates it was routine, well-known and conventional in the art to determine expression of S100A8, S100A9 and genotype filaggrin in in biological samples. The dependent claims do not provide significantly more to the claims outside of the judicial exception as they encompass conventional techniques as described in the instant specification as noted above.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leung (US2020/0113508 A1).
Leung teaches a method of identifying a subject at risk of developing atopic dermatitis in a subject. Leung teaches the subject is an infant that is up to two years of age (see para 38) (claim 2). Leung teaches obtaining a sample including a skin sample (see para 40) (claim 3). Leung teaches observing mutation status of FLG genotype. Leung teaches only four subject had FLG mutations (see para 69) thus teaches the other subjects had wild type FLG (claim 6). It is noted claim 6 only require a step of observing a mutation status of FLG using genetic material to determine FLG genotype. Because Leung teaches only 4 subjects with FLG mutations, Leung teaches observing mutation status of FLG in skin samples. Leung teaches determining expression of S100A8 and S100A9 in a skin sample from the subject. Leung teaches comparing the expression and detecting an increase S100A8 and S100A9 to a control sample (see para 36, 44, claim 8).
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.
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 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gittler (J Allergy Clin Immunol, 2012, pp 1344-1354) in view of Carson (2017, cited on IDS).
Gittler teaches obtaining skin samples from subjects with atopic dermatitis (see patient population). Gittler teaches obtaining skin samples from healthy volunteers (see patient population). Gittler teaches no filaggrin gene mutations were found (observing mutation status of FLG, wild type genotype detected) (see patient population) (claim 6). Gittler teaches S100A8 and S100A9 is increased in atopic dermatitis (see pg. 1351 and fig 6). Gittler does not teach analysis of samples from infants or skin sample from face or elbow.
However, it was well known in the art to obtain skin samples for analysis of atopic dermatitis in infants. Carson teaches obtain samples from face, cheek, elbow and determine FLG mutation status (see fig 1). Carson teaches analysis of children before age 7 years (see participants).
It would have been prima facie obvious to the ordinary artisan at the time the invention was made to include analysis of additional subjects and sample types, including infants and samples comprising cheeks and elbows as taught by Carson in the method of Gittler to allow for analysis of additional subjects, including infants to allow for determining propensity to develop atopic dermatitis because Carson teaches analysis of skin samples in subjects before the age of 7. The skilled artisan would have been motivated to include analysis of infants, including under the age of 2 and include analysis of additional skin samples to allow for a more robust sampling and allow for treatment of children because Carson teaches genetic analysis of skin samples from extremities including face, cheek, and elbow in children under the age of 7 with atopic dermatitis. Additionally the ordinary artisan would have had a reasonable expectation of success that children, including infants and samples comprising cheeks and elbows could be analyzed in the method of Gittler because Carson teaches genetic analysis of different skin sample areas in children and Gittler teaches expression analysis of skin samples in adults.
Claims 1- 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grzanka (Experimental Dermatology, 2012, 21, 184-188) in view of Carson (2017, cited on IDS).
Grzanka teaches obtaining skin biopsies from patients with moderate to severe AD. Grzanka teaches samples were taken before starting PIM treatment and teaches samples from healthy skin and AD skin (skin biopsies). Grzanka teaches a third sample was taken two weeks after PIM treatment (see skin biopsies). Grzanka teaches analysis of increased expression of S100A9 and S100A8/A9 in subjects with AD (observing expression in skin sample compared to control). Grzanka teaches subjects following PIM treatment had decreased expression of S100A9 and S100A8/A9 (see pg. 187, 1st column). Therefore, Grzanka teaches measuring level of S100A8/A9 before application of a skin treatment, applying skin treatment, measuring level of S100A8/A9 following treatment and determining beneficial treatment upon decreased expression of S100A8/A9. Grzanka does not teach analysis of infant skin or observing FLG mutation status.
However, it was well known in the art to obtain skin samples for analysis of atopic dermatitis in infants. Carson teaches obtain samples from face, cheek, elbow and determine FLG mutation status (see fig 1). Carson teaches analysis of children before age 7 years (see participants).
It would have been prima facie obvious to the ordinary artisan at the time the invention was made to include analysis of additional subjects and sample types, including infants and samples comprising cheeks and elbows as taught by Carson in the method of Grzanka to allow for analysis of additional subjects, including infants to include propensity to develop atopic dermatitis and evaluate therapy response for atopic dermatitis because Carson teaches analysis of skin samples in subjects before the age of 7. The skilled artisan would have been motivated to include analysis of infants, including under the age of 2 and include analysis of additional skin samples to allow for a more robust sampling and allow for treatment of children because Carson teaches genetic analysis of skin samples from extremities including face, cheek, and elbow in children under the age of 7 with atopic dermatitis. The skilled artisan would have been motivated to include analysis of infants and include analysis of additional skin samples to allow for a more robust sampling and allow for treatment of children. Additionally the ordinary artisan would have had a reasonable expectation of success that children, including infants and samples comprising cheeks and elbows could be analyzed in the method of Grzanka because Carson teaches genetic analysis of different skin sample areas in children and Grzanka teaches expression analysis of skin samples in adults.
Conclusion
No claims are allowable.
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/SARAE L BAUSCH/Primary Examiner, Art Unit 1699
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