DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s election without traverse of ADAM15 in the reply filed on December 19, 2025 is acknowledged.
Claims 1-2, 13, 15-16, and 34-35 are currently pending and have been examined herein.
The claims have been examined to the extent that the claims read on the elected marker (ADAM15). The additionally recited markers have been withdrawn from consideration as being directed to non-elected subject matter. Prior to allowance of the claim, any non-elected subject matter that is not rejoined with any allowed elected subject matter will be required to be removed from the claims.
Claim Rejections - 35 USC § 101
3. 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 1-2, 13, 15-16, and 34-35 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claims recite a judicial exception that is not integrated into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim analysis is set forth below.
Step 1: The claims are directed to the statutory category of a process.
Step 2A, prong one: Evaluate Whether the Claim Recites a Judicial Exception
The instant claims recite a law of nature.
The claims recite a correlation between the expression level of ADAM15 and the severity of a systemic eruption by atopic dermatitis. This type of correlation is a consequence of natural processes, similar to the naturally occurring correlation found to be a law of nature by the Supreme Court in Mayo.
The instant claims recite an abstract idea.
The claims recite “detecting” severity of systemic eruption by atopic dermatitis. The “detecting” broadly encompasses a mental processes. For example, one may “detect” the severity by thinking about the level of ADAM15. Mental processes, which are concepts performed in the human mind (including observation, evaluation, judgment, opinions) are considered to be abstract ideas.
Step 2A, prong two: Evaluate Whether the Judicial Exception Is Integrated Into a Practical Application
The claims do NOT recite additional steps or elements that integrate the recited judicial exceptions into a practical application of the exception(s). For example, the claims do not practically apply the judicial exception by including one or more additional elements that the courts have stated integrate the exception into a practical application:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
An additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
An additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
An additional element effects a transformation or reduction of a particular article to a different state or thing; and
An additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological
environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
In addition to the judicial exceptions the claims recite a step of measuring an expression level of ADAM15. This step is not considered to integrate the judicial exceptions into a practical application because it merely adds insignificant extra-solution activity (data gathering) to the judicial exception.
Step 2B: Evaluate Whether the Claim Provides an Inventive Concept
In addition to the judicial exceptions the claims recite a step of measuring an expression level of ADAM15. This step does not amount to significantly more because they simply append well understood, routine, and conventional activities previously known in the art, specified at a high level of generality, to the judicial exceptions.
The step is recited at a high level of generality. The measuring the expression of ADAM15 merely instructs one to perform any type of mRNA or protein expression analysis. When recited at this high level of generality, there is no meaningful limitation that distinguishes this step from well understood, routine, and conventional activities engaged in by scientists prior to applicants invention and at the time the application was filed.
Additionally the teachings in the specification demonstrate the well understood, routine, conventional nature of additional elements because it teaches that the additional elements are well known or commercially available. For example the specification teaches the following:
[0051] The expression level of the marker of the present invention can be measured according to a quantitative measurement method of nucleic acid or protein that is commonly used in the field. The expression level of a marker to be measured may be the expression level based on the absolute amount of a target marker in the biological specimen or may be a relative expression level with respect to the expression level of another standard material, the total nucleic acids, or the total proteins.
[0052] For example, the expression level of a nucleic acid marker may be measured according to a procedure of gene expression analysis that is commonly used in the field. Examples of the means of the gene expression analysis include methods for quantitatively measuring nucleic acid or amplification product thereof, such as PCR, multiplex PCR, real-time PCR, hybridization (DNA chip, DNA microarray, dot-blot hybridization, slot-blot hybridization, northern blot hybridization, and so on), sequencing, and chromatography. When the nucleic acid is RNA, it is preferable to convert the RNA into cDNA by reverse transcription and then perform quantitative measurement by the method above.
[0053] The expression level of a protein marker can be measured using a protein quantitative measurement method that is commonly used in the field, for example, immunoassay (for example, western blotting, ELISA, and immunostaining), fluorescence method, electrophoresis, protein chip, chromatography, mass spectrometry (for example, LC-MS/MS and MALDI-TOF/MS), 1-hybrid method (PNAS, 100, 12271-12276 (2003)), and 2-hybrid method (Biol. Reprod., 58, 302-311 (1998)). Alternatively, the expression level of the marker of the present invention may be measured by measuring a molecule that interacts with the nucleic acid or protein as the marker of the present invention. Examples of the molecule that interacts with the marker of the present invention include DNA, RNA, protein, polysaccharides, oligosaccharides, monosaccharides, lipids, fatty acids, and phosphorylated products, alkylated products, and glycosylated products thereof, and complexes of any of the above.
Further it is noted that the courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity.
Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017);
Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015);
Detecting DNA or enzymes in a sample, Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017);
Immunizing a patient against a disease, Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011);
Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546;
Freezing and thawing cells, Rapid Litig. Mgmt. 827 F.3d at 1051, 119 USPQ2d at 1375;
Amplifying and sequencing nucleic acid sequences, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014)
For the reasons set forth above the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 112b
4. 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, 13, 15-16, and 34-35 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.
Regarding Claims 1, 13, 15-16, and 34-35 it is not clear how the recited preamble is intended to breathe life and meaning into the claim. The preamble of the claim recites a method for detecting severity of systemic eruption by atopic dermatitis, yet the for the diagnosis and severity assessment of alcohol dependence, yet the method only requires a step of measuring an expression level of a marker for detecting severity of systemic eruption by atopic dermatitis in a subject. Thus it is not clear if applicant intends to cover only a method of measuring an expression level of a marker for detecting severity of systemic eruption by atopic dermatitis in a subject OR if the method is intended to somehow require more to accomplish the goal set forth in the preamble. If it is the later, then it appears that the claims are incomplete, as they fail to provide any active steps that clearly accomplish the goal set forth by the preamble of the claims.
Claim Rejections - 35 USC § 112(a)
5. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 13, 15-16, and 34-35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for
A method for determining the severity of systemic eruption by atopic dermatitis in a human subject, the method comprising:
(i) measuring the mRNA level of ADAM15 in a sebum sample obtained from the human subject; and
(ii) determining the severity of the systemic eruption by atopic dermatitis based on the measured mRNA level of ADAM15 in the sebum sample, wherein higher levels of ADAM15 mRNA are indicative of more severe systemic eruptions and higher Eczema Area and Severity Index (EASI) scores and lower levels of ADAM15 mRNA are indicative of less severe systemic eruptions and lower EASI scores.
does not reasonably provide enablement for the claims as broadly written. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Scope of the Claims/Nature of the Invention
The claims are drawn to a method for detecting severity of systemic eruption by atopic dermatitis in a subject. In view of the recitation of “subject”, the claims broadly encompass both human and non-human subjects.
The claims recite a first step of measuring an expression level of a marker for detecting severity of systemic eruption by atopic dermatitis in a subject. The claims state that the marker is ADAM15 or an expression product of ADAM15. The claims broadly encompass measuring the level of ADAM15 mRNA or protein. Only claims 34 and 35 are limited to ADAM15 nucleic acids. Additionally the claims broadly encompass measuring the level of ADAM15 in ANY type of sample (i.e., skin biopsy, blood, sebum, saliva, etc.) obtained from the subject. Only claim 35 is limited to a particular sample type, namely skin surface lipids.
The claims state that the severity is severity of atopic dermatitis corresponding to Eczema Area and Severity Index.
Claim 2 recites that the method further comprises detecting severity of systemic eruption by atopic dermatitis in the subject based on the expression level of the marker. Here the claims broadly encompass a method wherein high levels of ADAM15 or low levels of ADAM15 are indicative of more severe systemic eruptions. Only claims 13 and 16 specifically state that the higher the expression level of the ADAM15 is, the worse the severity of systemic eruption by atopic dermatitis in the subject is.
The nature of the invention requires a reliable correlation between the level of ADAM15 mRNA and protein in ANY sample type and severity of systemic eruption by atopic dermatitis.
Teachings in the Specification and Examples
The specification (Example 1) describes how the inventors searched from markers for detecting severity of atopic dermatitis.
The specification (para 0169) teaches that subjects were 18 adults (23- to 57-year old males) having atopic dermatitis (AD). The subjects visited four times every 14 days and were subjected to acquisition of a score associated with the severity of AD and collection of SSL. One of the scores that is associated with the severity of AD that was used was the systemic EASI score (Hanifin, et al., Exp. Dermatol., 10, 2001, scoring each symptom from 0 to 72 based on systemic eruption).
The specification (paras 0173-0174) teaches that sebum samples (which contain skin surface lipids) were collected from the whole face of each subject using an oil blotting film. RNA was obtained from this sample and used for nucleic acid sequencing.
The specification (para 0177) teaches that using the 1st EASI scores and the 1st gene expression levels of 4,845 genes, Spearman's correlation coefficient Rs between the EASI score and the expression level of each gene was calculated. Similarly, Rs was calculated between the 2nd to 4th EASI scores and the gene expression levels, respectively. The Rs each calculated was referred to as 1st to 4th Rs for each gene.
The specification (para 0178) teaches that regarding each gene, the number of times the p value (p_val) was below 0.1 in the 1st to 4th Rs (this number of times was defined as A value) and the number of times the p value was below 0.05 in the 1st to 4th Rs (this number of times was defined as B value) were examined. The specification teaches that the correlation with the EASI score was high for four genes, including ADAM15 (see Table 2).
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State of the Art and the Unpredictability of the Art
While methods of measuring markers are known in the art, methods of correlating biomarkers with a phenotype (such as severity of systemic eruption by atopic dermatitis) are highly unpredictable. The unpredictability will be discussed below.
The claims broadly encompass a method wherein high levels of ADAM15 OR low levels of ADAM15 are indicative of more severe systemic eruptions. However the teachings in the specification do not provide support for the breadth of the claims. The specification only teaches that higher levels of ADAM15 are associated with more severe system eruptions of atopic dermatitis. It is highly unpredictable if lower levels of ADAM15 will ever be correlated with less severe systemic eruptions of atopic dermatitis.
The claims broadly encompass a method for detecting severity of systemic eruption by atopic dermatitis based on the expression level of ADAM15 in ANY type of sample (i.e., skin biopsy, blood, sebum, saliva, etc.) obtained from the subject. However the specification only discloses the level of ADAM15 in sebum samples. It is highly unpredictable if the level of ADAM15 observed in sebum samples can be extrapolated to other sample types encompassed by the claims. The prior art of Blok (British Journal of Dermatology Vol 174 Issue 6 June 2016 pages 1392-1394) teaches that they performed mRNA microarray studies to compare gene expression in lesional skin vs. healthy skin of patients with HS. Also, the gene expression profiles in whole blood of patients and unaffected individuals were determined (page 1392, col 1). Blok teaches that 800 genes were differentially expressed between lesional and clinically healthy skin (page 1392, col 2). However no significant differences were identified in whole blood mRNA expression between patients and health controls (page 1392, col 2). Thus in the absence of evidence to the contrary it is highly unpredictable if the ADAM15 levels observed in sebum samples will be the same in other types of samples encompassed by the claims.
Further it is relevant to note that the prior art of Mobus (J Allergy ClinImmunol Vol 147 No 1 pub online 6/29/2020) teaches that they conducted experiments to explore the skin transcriptome of patients with moderate to severe atopic dermatitis (abstract). Skin biopsy samples were obtained from AD patients before the initiation of systemic therapy and three months after therapy. Disease activity was evaluated using the Eczema Area and Severity Index (EASI). Additionally skin biopsy samples were collected from healthy volunteers with no history of AD. RNA was obtained from the skin samples and subject to RNA-Seq (page 214). Mobus did not find a correlation between ADAM15 and EASI score since the reported spearman correlation coefficient for ADAM15 was -0.081 (see supplementary table E10). This supports the Examiners position that it is highly unpredictable if the results obtained in the specification with sebum can be extrapolated to skin biopsy samples, since Mobus also looked at a correlation between ADAM15 and EASI and could not find one in skin biopsy samples.
Additionally it is relevant to point out the unpredictability as to whether or not a measure of RNA expression is indicative of the level of protein in a sample. Chan (G&P magazine 2006 Vol 6 No 3 pages 20-26). teaches that cells have elaborate regulatory mechanisms at the level of transcription, post-transcription, and post-translation (p.1, last paragraph), and that transcript and protein abundance measurements may not be concordant (p.3, sixth full paragraph). Thus it is unpredictable as to whether or not the results pertaining to mRNA expression, as presented in the instant specification, would be applicable to methods requiring or encompassing the analysis of protein expression.
Because the claims encompass both human subjects and non-human subjects, whereas the instant specification provides analysis of only human samples, it is relevant to point out that there is a large amount of unpredictability with regard to comparing results from gene expression analysis data in humans to other even closely related animals. Hoshikawa et al (Physical Genomics 2003 Vol 12 pages 209-219) teaches unpredictability with regard to applying gene expression results among different organisms. The reference teaches the analysis of gene expression in lung tissue in response to hypoxic conditions which lead to pulmonary hypertension (Fig. 1). The reference teaches that the gene expression profile in mouse is different from that observed in rat (Tables 1-4; p.209 - Abstract). Thus it is not predictable that the findings with respect to human subjects could be extrapolated to non-human subjects.
Quantity of Experimentation:
The quantity of experimentation necessary is great, on the order of many man-years, and then with little if any reasonable expectation of successfully enabling the full scope of the claims. In support of this position, it is noted that the claimed methods encompass being able to use the level of ADAM15 in ANY type of sample to detect severity of systemic eruptions by atopic dermatitis.
In order to practice the breadth of the claimed invention one of skill in the art would first have to recruit atopic dermatitis subjects currently having systemic eruptions. Those subjects would have to provide serially collected samples comprising a representative number of different sample types (skin, sebum, blood, saliva etc.). At the time of sample collection the subjects would also have to be scored with respect to EASI. Then ADAM15 mRNA and protein levels would have to be detected in the samples. Then all the data would need to be analyzed to determine if ADAM15 is differentially expressed between the samples obtained from subjects having low and high EASI scores. The analysis would have to include both human and non-human subjects. The specification has merely provided an invitation for further experimentation. The results of such experimentation are highly unpredictable.
The amount of experimentation that would be required to practice the full scope of the claimed invention and the amount of time and cost this experimentation would take supports the position that such experimentation is undue. Attention is directed to Wyeth v. Abbott Laboratories 107 USPQ2d 1273, 1275, 1276 (Fed. Cir. June 2013):
Claims are not enabled when, at the effective filing date of the patent, one of ordinary skill in the art could not practice their full scope without undue experimentation. MagSil Corp. v. Hitachi Global Storage Techs., Inc., 687 F.3d 1377, 1380-81 [103 USPQ2d 1769] (Fed. Cir. 2012).
The remaining question is whether having to synthesize and screen each of at least tens of thousands of candidate compounds constitutes undue experimentation. We hold that it does. Undue experimentation is a matter of degree. Chiron Corp. v. Genentech, Inc., 363 F.3d 1247, 1253 [70 USPQ2d 1321] (Fed. Cir. 2004) (internal quotation omitted). Even “a considerable amount of experimentation is permissible,” as long as it is “merely routine” or the specification “provides a reasonable amount of guidance” regarding the direction of experimentation. Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342, 1360-61 [47 USPQ2d 1705] (Fed. Cir. 1998) (internal quotation omitted). Yet, routine experimentation is “not without bounds.” Cephalon, Inc. v. Watson Pharm., Inc., 707 F.3d 1330, 1339 [105 USPQ2d 1817] (Fed. Cir. 2013). (Emphasis added)
In Cephalon, although we ultimately reversed a finding of nonenablement, we noted that the defendant had not established that required experimentation “would be excessive, e.g., that it would involve testing for an unreasonable length of time.” 707 F.3d at 1339 (citing White Consol. Indus., Inc. v. Vega Servo-Control, Inc., 713 F.2d 788, 791 [218 USPQ 961] (Fed. Cir. 1983)). Finally, in In re Vaeck, we affirmed the PTO's nonenablement rejection of claims reciting heterologous gene expression in as many as 150 genera of cyanobacteria. 947 F.2d 488, 495-96 [20 USPQ2d 1438] (Fed. Cir. 1991). The specification disclosed only nine genera, despite cyanobacteria being a “diverse and relatively poorly understood group of microorganisms,” with unpredictable heterologous gene expression. Id. at 496. (Emphasis added)
Additionally, attention is directed to Cephalon at 1823, citing White Consol. Indus., Inc. v. Vega Servo-Control, Inc., 218 USPQ 961, that work that would require 18 months to 2 years so to enable the full scope of an invention, even if routine, would constitute undue experimentation. As stated therein:
Permissible experimentation is, nevertheless, not without bounds. This court has held that experimentation was unreasonable, for example, where it was found that eighteen months to two years’ work was required to practice the patented invention. See, e.g., White Consol. Indus., Inc. v. Vega Servo-Control, Inc., 713 F.2d 788, 791 [218 USPQ 961] Fed. Cir.1983). (Emphasis added)
Attention is also directed to MPEP 2164.06(b) and In re Vaeck, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991).
Where, as here, a claimed genus represents a diverse and relatively poorly understood group of microorganisms, the required level of disclosure will be greater than, for example, the disclosure of an invention involving a “predictable” factor such as a mechanical or electrical element. See Fisher, 427 F.2d at 839, 166 USPQ at 24.
In view of such legal precedence, the aspect of having to work for so many years just to provide the starting materials for minute fraction of the scope of the claimed invention is deemed to constitute both an unreasonable length of time and undue experimentation.
Conclusions:
Herein, although the level of skill in the art is high, given the lack of disclosure in the specification and in the prior art and the unpredictability of the art, it would require undue experimentation for one of skill in the art to make and use the invention as broadly claimed.
Claim Rejections - 35 USC § 102
6. 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, 13, 15-16, and 34-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mobus (J Allergy ClinImmunol Vol 147 No 1 pub online 6/29/2020).
As noted in MPEP 2111.02, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the present situation, the process steps are able to stand alone and the preamble limitation is not accorded patentable weight. Accordingly, the claim language of “A method for detecting severity of systemic eruption by atopic dermatitis in a subject” merely sets forth the purpose of the process, but does not limit the scope of the claims.
Regarding Claim 1 Mobus teaches that they conducted experiments to explore the skin transcriptome of patients with moderate to severe atopic dermatitis (abstract). Skin biopsy samples were obtained from AD patients before the initiation of systemic therapy and three months after therapy. Disease activity was evaluated using the Eczema Area and Severity Index (EASI). Additionally skin biopsy samples were collected from healthy volunteers with no history of AD. RNA was obtained from the skin samples and subject to RNA-Seq (page 214). Mobus teaches that ADAM15 is differentially expressed in skin samples obtained from subjects with AD compared to healthy subjects (Fig 1B). It is further noted that Mobus did not find a correlation between ADAM15 and EASI score since the reported spearman correlation coefficient for ADAM15 was -0.081 (see supplementary table E10). Thus Mobus teaches a method of measuring an expression level of ADAM15 in a subject. While Mobus teaches the only active process step of the method, Mobus does not teach a correlation between ADAM15 and EASI score. However this art rejection is set forth because it teaches a broad interpretation of the claims which does not require such a correlation. As discussed above, the preamble only sets forth an intended use of the claimed method and does not limit the scope of the claims.
Regarding Claim 13 Mobus teaches a method of detecting ADAM15. The recitation that the higher the expression level of the marker is, the worse the severity of systemic eruption by atopic dermatitis in the subject merely sets forth a property of ADAM15 but does not require any additional steps to be performed.
Regarding Claim 15 Mobus teaches a method comprising measuring the expression level of ADAM15 before and after treatment. Thus Mobus teaches measuring the expression level of ADAM15 at different time point.
Regarding Claim 16 Mobus teaches a method of detecting ADAM15. The recitation that when the measured expression level of the marker in the subject is higher than the expression level in the subject at previous measurement, the severity of systemic eruption by atopic dermatitis in the subject is detected to be exacerbated, or when the measured expression level of the marker in the subject is lower than the expression level in the subject at previous measurement, the severity of systemic eruption by atopic dermatitis in the subject is detected to be remitted merely sets forth a property of ADAM15 but does not require any additional steps to be performed.
Regarding Claim 34 Mobus teaches a method wherein the marker is nucleic acid.
Regarding Claim 35 Mobus teaches a method wherein the marker is mRNA collected from a skin biopsy sample. In the instant case a skin biopsy sample is expected to comprise skin surface lipids.
Improper Markush Grouping Rejection
7. Claims 1-2, 13, 15-16, and 34-35 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The claims recite the following Markush group:
at least one selected from the group consisting of: TWF1, ADAM15, CIZ1, and SETD1B (see claims 1, 13, and 16).
This Markush grouping is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
MPEP 2117(II) states that “A Markush claim may be rejected under judicially approved “improper Markush grouping” principles when the claim contains an improper grouping of alternatively useable members. A Markush claim contains an “improper Markush grouping” if either: (1) the members of the Markush group do not share a “single structural similarity” or (2) the members do not share a common use. Supplementary Guidelines at 7166 (citing In re Harnisch, 631 F.2d 716, 721-22, 206 USPQ 300, 305 (CCPA 1980)).
MPEP 2117(II) further state that alternatives (1) share a “single structural similarity” when they belong to the same recognized physical or chemical class or to the same art-recognized class and (2) share a common function or use when they are disclosed in the specification or known in the art to be functionally equivalent in the context of the claimed invention.
MPEP § 2117(II)(A) states that “A recognized physical class, a recognized chemical class, or an art-recognized class is a class wherein “there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved”. Herein the members of the Markush grouping are all gene/proteins. These do not belong to the same recognized physical or chemical class or to the same art-recognized class because there is no expectation from the art that each of the recited genes/proteins would function in the same way in the claimed method. It is only in the context of this specification that it was disclosed that all members of this group may behave in the same way in the context of the claimed invention.
MPEP § 2117(II)(B) states that “Where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as explained in subsection IIA above, the members of the Markush grouping may still be considered to be proper where the alternatives share a substantial structure feature that is essential to a common use. Again the members of the Markush grouping are all gene/proteins. While they are all made up of nucleic acids or amino acids, the structure of comprising nucleic acids or amino acids is not essential to any asserted common use.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA HANEY whose telephone number is (571)272-8668. The examiner can normally be reached Monday-Friday, 8:15am-4:45pm EST.
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, Wu-Cheng Shen can be reached at 571-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA HANEY/ Primary Examiner, Art Unit 1682