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. This action is in response to the papers filed July 10, 2026. Applicant’s remarks and amendments have been fully and carefully considered but are not found to be sufficient to put the application in condition for allowance. Any new grounds of rejection presented in this Office Action are necessitated by Applicant's amendments. Any rejections or objections not reiterated herein have been withdrawn. This action is made FINAL.
Claims 1 and 34-35 are currently pending and have been examined herein.
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 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 “comparing” the expression level measured at a later time point with the expression level measured at an earlier time point as a reference value. The “comparing” broadly encompasses a mental processes. For example, one may “compare” the expression levels by reading them on a laboratory chart and thinking about if the second one is greater than or less than the first one. 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 at different time points in a sample of skin surface lipids. 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 at different time points in a sample of skin surface lipids. 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 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.
The teachings in the prior art 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 prior art teaches the following:
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 (abstract). Gene expression was determined by RNA-Seq (page 214). Figure 5 B shows a comparison of gene expression levels before and after treatment.
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.
Response To Arguments
4. In the response the Applicants traversed the rejection under 35 USC 101. Regarding Step 2A, Prong 1, the Applicants argue that the claims as amended recite method steps that cannot practically be performed in the human mind. The recited method requires physical sample collection, laboratory measurement using specific nucleic acid techniques (amplification or sequencing), and quantitative comparison of measured values over time. These steps are not mere mental observations-they require specific instrumentation and technical methodology that the human mind is not equipped to perform.
This argument has been considered but is not persuasive. As explained in the rejection the “comparing” can be done by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams).
Additionally the Applicants argue that to the extent a natural correlation is recited, the claims are not “directed to” the correlation itself. Rather, the claims are directed to a specific, practical method that uses the correlation to achieve a diagnostic result-determining whether AD severity is exacerbating or remitting based on temporal changes in ADAM15 expression in SSL. The claims do not preempt all uses of the natural correlation; they are limited to a specific sample type (skin surface lipids), a specific measurement methodology (nucleic acid amplification or sequencing), and a specific diagnostic framework (temporal comparison with the earlier measurement as the reference).
This argument has been fully considered but is not persuasive. It is maintained that the claims recite a correlation between ADAM15 and severity of systemic eruption by atopic dermatitis. This type of correlation is a consequence of natural processes and is considered to be a law of nature. Further, it is noted that preemption is not a stand-alone test for eligibility. While a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible.
Regarding Step 2A prong 2, the Applicants argue that the claims recite additional elements that integrate the alleged judicial exception into a practical application. Amended claim 1 has the practical application of a method for detecting whether the severity of systemic eruption by atopic dermatitis in a subject is exacerbating or remitting. They argue that the combination of elements imposes meaningful limits on the claim scope. The claims are not merely "generally linking" a natural correlation to a technological environment. Rather, they require a specific, defined protocol: collection of skin surface lipids, measurement of ADAM15 expression using nucleic acid amplification or sequencing at multiple time points, and a quantitative comparison that yields a clinically meaningful result (exacerbation vs. remission). This provides a physician or clinician with actionable information about the trajectory of a patient's AD severity over time-an improvement over existing methods that rely solely on subjective visual observation.
This argument has been fully considered but is not persuasive. In addition to the judicial exceptions the claims recite a step of measuring an expression level of ADAM15 at different time points in a sample of skin surface lipids. 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.
Regarding Step 2B the Applicants argue that the claims as a whole add "significantly more" to the alleged judicial exception because they include a combination of elements that are not well- understood, not routine, and/or not conventional. They argue that the claims are novel over the prior art of Mobus (J Allergy ClinImmunol Vol 147 No 1 pub online 6/29/2020).
This argument has been fully considered but is not persuasive. Applicants are reminded that the test for what is well known, routine, and conventional in the art is distinct from the test for what is novel. It is maintained that Mobus teaches measuring expression levels of genes by a sequencing method at different time points in a sample of skin surface lipids. The prior art and the specification provide evidence that the limitations in additional to the judicial exceptions are routine and well understood. The rejection is maintained.
Claim Rejections - 35 USC § 112b
5. 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 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 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 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 at different time points and “comparing” the expression level measured at a later time point with the expression level measured at an earlier timepoint as a reference value. 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 at different time points and “comparing” the expression level measured at a later time point with the expression level measured at an earlier timepoint as a reference value 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. It is noted that the claims as amended state “wherein when the measured expression level is higher than the reference value, the severity of systemic eruption by atopic dermatitis in the subject is detected to be exacerbated, and when the measured expression level is lower than the reference value, the severity of systemic eruption by atopic dermatitis in the subject is detected to be remitted”, however Applicants are reminded that claim scope is not limited by claim language (such as wherein clauses) that suggests or makes optional but does not require steps to be performed.
Response To Arguments
6. In the response the Applicants traversed the rejection under 35 USC 112(b). The Applicants argue that they have amended claim 1 to include step (b), which recites comparing the expression level measured at a later time point with the expression level measured at an earlier time point as a reference value, and further recites that when the measured expression level is higher than the reference value, the severity is detected to be exacerbated, and when the measured expression level is lower than the reference value, the severity is detected to be remitted. They argue that the inclusion of step (b) clearly sets forth the active method steps that accomplish the “detecting severity” goal stated in the preamble.
This argument has been fully considered but is not persuasive because the claims as amended to do not recite an active process step that accomplishes the goal set forth by the preamble. The claims only recite steps of measuring and comparing. Regarding the “wherein” clause recited in step (b), it is noted that cclaim scope is not limited by claim language (such as wherein clauses) that suggests or makes optional but does not require steps to be performed. This rejection could be overcome by amending the claims to recite an active process step of detecting severity.
Claim Rejections - 35 USC § 112(a)
7. 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 detecting severity of systemic eruption by atopic dermatitis in a human subject, the method comprising:
(a) collecting samples of skin surface lipids from the human subject at different time points;
(b) measuring an amount of ADAM15 RNA in each of the collected samples;
(c) determining that the severity of systemic eruption by atopic dermatitis in the human subject is exacerbated when the amount of ADAM15 RNA is higher at a later time point in comparison to the amount of ADAM15 RNA in a sample collected at an earlier time point or determining that the severity of systemic eruption by atopic dermatitis in the human subject is remitted when the amount of ADAM15 RNA is lower at the later time point in comparison to the amount of ADAM15 RNA in a sample collected at an earlier time point,
wherein the severity is severity of atopic dermatitis corresponding to Eczema Area and Severity Index.
does not reasonably provide enablement for the claims which broadly encompass (i) non-human organisms and (ii) the analysis of ADAM15 protein levels. 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 the subject at different time points, wherein the marker for detecting severity of systemic eruption by atopic dermatitis is ADAM15 and its expression products in skin surface lipids collected from the subject, and the expression level is measured using a nucleic acid amplification method or a sequencing method. In view of the recitation of “ADAM15 and its expression products”, the claims broadly encompass measuring the level of ADAM15 mRNA or protein. The “sequencing method” broadly encompasses nucleic acid sequencing or amino acid sequencing methods. Only claims 34 and 35 are limited to ADAM15 nucleic acids.
The claims recite a second step of (b) comparing the expression level measured at a later time point with the expression level measured at an earlier time point as a reference value, wherein when the measured expression level is higher than the reference value, the severity of systemic eruption by atopic dermatitis in the subject is detected to be exacerbated, and when the measured expression level is lower than the reference value, the severity of systemic eruption by atopic dermatitis in the subject is detected to be remitted, wherein the severity is severity of atopic dermatitis corresponding to Eczema Area and Severity Index.
The nature of the invention requires a reliable correlation between the level of ADAM15 mRNA and protein 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.
In the instant case 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:
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 skin surface lipid samples. 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.
Response To Arguments
8. In the response the Applicants traversed the rejection under 35 USC 112(a)- Enablement. The Applicants argue that the rejection should be withdrawn because the claims as amended address each of the concerns raised in the prior Office Action. They argue that claim 1 now requires that the expression level is measured using a nucleic acid amplification method or a sequencing method, thereby requiring nucleic acid-based measurement to be consistent with the specification's experimental methodology.
This argument has been fully considered but is not persuasive. The Examiner does not agree that the claims are limited to nucleic acid analysis because they recite measuring the expression level of “ADAM15 and its expression products”. The recitation of expression products could encompass the proteins. Further the recitation of “sequencing method” broadly encompasses nucleic acid sequencing or amino acid sequencing methods. Only claims 34 and 35 are limited to ADAM15 nucleic acids. Additionally it is noted that the Applicants did not address that the claims encompass the analysis of samples from humans and non-humans subjects. The rejection is maintained for these reasons.
9. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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.
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/AMANDA HANEY/ Primary Examiner, Art Unit 1682
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