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 of Group I in the reply filed on July 31, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant's election with traverse of SEQ ID NO: 1 (ssc-miR-205) in the reply filed on July 31, 2026 is acknowledged. The traversal is on the ground(s) that the species are all significantly altered in DON low or DON high group as compared to the control. They argue that it is not relevant that the miRNA’s have different targets. Further they argue that the claim only recites a few species and it would not impose a serious burden to search all of them. These arguments have been fully considered but are not persuasive. The SEQ ID NOs: of claim 1 would be regarded as having the same or corresponding technical feature if the alternatives had a common property or activity, and shared a significant structural element that is essential to the common property or activity. Since the claimed SEQ ID NOs: are not homologous to each other, they fail to share a common structure i.e., a significant structural elements. Therefore the eight recited SEQ ID NOs: do not share any significant structural element and cannot be considered as having the same or corresponding technical feature. The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 3-9, and 11-22 are currently pending.
Claims 11-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 31, 2026.
The claims have been examined to the extent that the claims read on the elected miRNA (SEQ ID NO: 1 (ssc-miR-205)). The additionally recited miRNAs have been withdrawn from consideration as being directed to non-elected subject matter.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.
Specification
3. Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains legal phraseology (“said”). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
4. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (pages 16 and 38). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 101
5. 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 3-9 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 abstract ideas.
The claims recite a step of “detecting” a trichothecene effect if the expression level of said at least one miRNA in the test sample deviates in comparison with a reference value. The “detecting” step broadly encompasses a mental process. For example, one my “detect” a trichothecene effect by reading a laboratory report with the expression level of the miRNA in the test sample and the reference value and thinking about whether they are the same or different. Mental processes, which are concepts performed in the human mind (including observation, evaluation, judgment, opinions) are considered to be abstract ideas.
The instant claims recite a law of nature.
The claims recite a correlation between the expression level of ssc-miR-205 and a trichothecene effect. 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.
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 determining in a test sample that is a blood sample the expression level of a miRNA having at least 90 % sequence identity, having at least 95 % sequence identity, or being identical to SEQ ID NO: 1 (ssc-miR-205). This step is not considered to integrate the judicial exception 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 determining in a test sample that is a blood sample the expression level of a miRNA having at least 90% sequence identity, having at least 95% sequence identity, or being identical to SEQ ID NO: 1 (ssc-miR-205). This step does NOT amount to significantly more because it simply appends well understood, routine, and conventional activities previously known in the art to the judicial exceptions.
The step is recited at a high level of generality. Determining the level of miRNA in a blood sample merely instructs a scientist to use any miRNA detection technique. The claim does not require the use of any particular non-conventional reagents (primers, probes, etc.). 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 (para 0021) teaches:
The term “expression level” of a polynucleotide such as e.g. an mRNA molecule or a miRNA, refers to a relative or absolute amount of said polynucleotide. Expression levels of polynucleotides can be determined by appropriate strategies known to a person skilled in the art including but not limited to microarray experiments, quantitative real-time PCR (qPCR), or so-called next-generation sequencing (NGS) technologies offered e.g. by Illumina, Pacific Biosciences, Oxford Nanopore Technologies etc. Preferred methods for detecting miRNA expression are quantitative real-time PCR and sequencing methods, e.g. as essentially described in Example 1, with sequencing methods being most preferred.
The prior art also demonstrates the well understood, routine, conventional nature of additional elements because it teaches that the additional elements are well known or commercially available. For example Reliszko (Reproduction 2017 Vol 154 pages 217-228) teaches detection of miRNAs, including ssc-miR-205 in the maternal serum of pregnant pigs (abstract, Table 3).
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 § 112
6. 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 and 3-9 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 if a subject of the species Sus scrofa has been exposed to deoxynivalenol (DON), comprising:
measuring the expression level of SEQ ID NO: 1 (ssc-miR-205) in a serum sample obtained from the subject;
determining that the subject has been exposed to DON when the expression level of SEQ ID NO: 1 is increased in comparison to the expression level of SEQ ID NO: 1 in a serum sample obtained from control subjects of the species Sus scrofa that have not been exposed to DON,
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 a trichothecene effect. In view of the recitation of “trichothecene” the claims broadly encompass a large family of chemically related, toxic mycotoxins produced by various fungi, including Fusarium, Stachybotrys, and Trichoderma. Claim 4 is limited to type B trichothecenes. Claim 5 is limited to deoxynivalenol (DON) or a deoxynivalenol derivative.
The claims recite a first step of determining in a test sample that is a blood sample the expression level of a miRNA having at least 90 % sequence identity, having at least 95 % sequence identity, or being identical to SEQ ID NO: 1 (ssc-miR-205). In view of the recitation of “blood sample” the claims broadly encompass ANY type of blood sample (i.e., whole blood, plasma, or serum). Further the claims encompass detecting the expression level of miR-205 in both human and non-human organisms, as long as the sequence shares at least 90% identity to SEQ ID NO: 1. Claim 7 is limited to mammals, avians, or fish. Claim 8 is limited to Sus scrofa.
The claims recite a second step of detecting a trichothecene effect if the expression level of the miRNA in the test sample deviates in comparison with a reference value, wherein the reference value corresponds to the expression level of the miRNA in a control blood sample. In view of the recitation of “deviates” the claims broadly encompass a method wherein the expression level of the miRNA is increased or decreased in the test sample in comparison to the reference value. Further the claims encompass ANY type of control blood sample (i.e., from a subject exposed to trichothecene, from a subject without exposure to trichothecene, from a subject with cancer, etc.).
The nature of the invention requires a reliable correlation between the expression level of SEQ ID NO: 1 (ssc-miR-205) and trichothecene effect.
Teachings in the Specification and Examples
The specification (para 0164) teaches that female weaned pigs were allocated to different treatment groups (Control, DON low, DON high). After an acclimatization period of 8 days, piglets received diets containing different levels of mycotoxins for 27 days. From day 28-36, all treatment groups received control diet (no mycotoxins added).
The specification (para 0165) teaches that on day 0, 7, 14, 21, 26, 32 and 35/36, serum samples were collected from individual animals.
The specification (para 0168) teaches that serum samples from the Control, DON low and DON high group collected on day 26 were subjected to small RNA sequencing. The specification (para 0175) teaches that differential abundance analysis showed that 15 (DON low vs Control) and 16 (DON high vs Control) miRNAs were significantly altered after DON exposure (FDR<10%, Table 2). In total, eight miRNAs were significantly altered in both DON low and DON high (Table 2, highlighted in bold). Out of those, four miRNAs were down-regulated upon DON treatment (ssc-miR-10b, ssc-miR-99b, ssc-miR-192, ssc-miR-374a-3p), and four were up-regulated in DON exposed pigs (ssc-miR-16, ssc-miR-128, ssc-miR-205, ssc-miR-451).
The specification (para 0170) teaches that serum samples from the Control, DON low and DON high group collected on day 26 were subjected to targeted analysis of ssc-miR-16, ssc-miR-128, ssc-miR-205 and ssc-miR-451.The specification (para 0177) teaches that normalized Cq-value log 2 fold change for ssc-miR-16, ssc-miR-128, ssc-miR-205 and ssc-miR-451 were increased in the DON groups compared to the Control (Table 4).
State of the Art and the Unpredictability of the Art
While methods of measuring miRNA are known in the art, methods of correlating miRNA levels with a phenotype (such as trichothecene effect) are highly unpredictable. The unpredictability will be discussed below.
In the instant case the claimed methods are highly unpredictable. The claims are drawn to a method of detecting a trichothecene effect based on the expression level of SEQ ID NO: 1 (ssc-miR-205). The claims broadly encompass a method wherein a trichothecene effect is detected when the level of SEQ ID NO: 1 (ssc-miR-205) is OVER or UNDER expressed in comparison to a reference value of expression for SEQ ID NO: 1 (ssc-miR-205) in ANY type of control blood sample (i.e., from a subject exposed to trichothecene, from a subject without exposure to trichothecene, from a subject with cancer, etc.). However this breadth is not supported by the teachings of the specification since the specification only teaches that SEQ ID NO: 1 (ssc-miR-205) is over expressed in serum samples in comparison to serum samples from subjects that were not exposed to DON.
Additionally it is highly unpredictable as to whether the results obtained in Sus scrofa could be extrapolated to ANY subject including ANY type of mammal, avian, or fish. Knowledge that miR-205 is over expressed in serum samples from Sus scrofa that have been exposed to DON, does not allow one to conclude that miR-205 is over expressed in serum samples from other subjects that have been exposed to DON. Relevant to the instant claims Ha (Biochim Biophys Acta 2008 November 1779(11) 735-742) teaches that many miRNAs and their targets are conserved among plants or animals, whereas some are specific to a few plant or animal lineages. Conserved miRNAs do not necessarily exhibit the same expression levels or patterns in different species or at different stages within a species (abstract). Further Ghorai (Frontiers in Genetics April 2014 Vol 5 article 100) discloses the number of miRNAs of different species. Notably, the reference teaches 1876 miRNA in the H. sapiens genome, 327 miRNA in the G. gorilla genome, 558 miRNA in the mulatta genome, 801 miRNA in the B. taurus genome etc. (see Table 1). As such it is unpredictable as to whether miR-205 is even present in other organisms and if so if it will be associated with a trichothecene effect.
Because the claims broadly encompass detecting a trichothecene effect by measuring the expression level of miR-205 in ANY type of blood sample, it is relevant to point out that it is highly unpredictable as to whether the results obtained with serum samples could be extrapolated to other blood sample types. For example, the prior art of Mompeon (Scientific Reports March 25, 2020 10:5373) teaches that they conducted a study to if blood starting material is a source of variance in miRNA profile by performing a paired comparison in plasma and serum of the expression of primary miRNAs associated with CVD. Circulating miRNA yield was similar in both plasma and serum, although a significant increase was observed in patients with Non-ST-elevation myocardial infarction (NSTEMI) compared to control volunteers. When normalized by the expression of miR-484, different patterns of miRNA expression between serum and plasma were observed. Although NSTEMI modified the expression of miR-1 and miR-208 in both serum and plasma, plasma displayed a higher variance than serum (Levene’s test p < 0.01). For miR-133a and miR-26a, differences were only detected in serum (p = 0.0240), and conversely, miR-499a showed differences only in plasma of NSTEMI (p = 0.001). Interestingly, miR-21 showed an opposite pattern of expression, being increased in serum (2−ΔΔCt: 5.7, p = 0.0221) and decreased in plasma (2−ΔΔCt: 0.5, p = 0.0107). Plasma and serum exhibit different patterns of circulating miRNA expression in NSTEMI and suggest that results from studies with different starting material could not be comparable (abstract). In the instant case the inventors only measured the miRNA in serum samples. There is no analysis of the miRNA in whole blood or plasma samples. In the absence of evidence to the contrary it is highly unpredictable if the increased expression level of miR-205 in serum samples from subjects exposed to DON will also be observed whole blood and plasma samples from those subjects.
Finally it is highly unpredictable if findings with DON could be extrapolated to any trichothecene. The prior art of Alassane-Kpembi (Scientific Reports 7:7530 8/2017) teaches that to obtain an in-depth view of the intestinal toxicity of FX, we evaluated the global impact of FX (2 µM and 10 µM) compared with DON (10 µM) on the intestinal transcriptome using a porcine pan-genomic microarray. Exposure to FX and DON resulted in clear modification of the transcriptomic profiles of the intestine (Fig. 3). A total of 738 genes were differentially expressed (DE) (adjusted P value < 0.05), with fold-change values ranging from −2.17 to 9.8. The number of DE genes increased from 372 to 517 following treatment with 2 µM and 10 µM of FX, whereas 411 genes were differentially expressed in response to 10 µM of DON (page 3). Thus the prior art demonstrates that different type B trichothecenes have different effects on the transcriptome. In the absence of evidence to the contrary, it is highly unpredictable if miR-205 will be over expressed in response to any trichothecene.
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 detect an effect of any type of trichothecene by determining the expression level of miR-205 in any type of blood sample obtained from any type of subject.
In order to practice the breadth of the claimed invention one of skill in the art would first have to gather a representative number of different mammalian, aviain, and species. The species would have to be fed food with contaminated with a representative number of different types of trichothecene. Then miRNA would need to be extracted from whole blood, serum, and plasma samples and used to measure the expression level of miR-205. 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.
Improper Markush Group
7. Claims 1, 3-9 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 § 706.03(y).
The claims recite the following Markush groups:
-at least one miRNA having at least 90 % sequence identity, preferably having at least 95 % sequence identity, or being identical to a sequence selected from the group consisting of SEQ ID NO: 1 (ssc-miR-205), SEQ ID NO: 2 (ssc-miR-128), SEQ ID NO: 3 (ssc-miR-16),SEQ ID NO: 4 (ssc-miR-451), SEQ ID NO: 5 (ssc-miR-10b), SEQ ID NO: 6 (ssc-miR- 99b), SEQ ID NO: 7 (ssc-miR-192), and SEQ ID NO: 8 (ssc-miR-374a-3p)
-wherein the at least one miRNA comprises one or two of: (i) a miRNA having at least 90 % sequence identity, preferably having at least 95 % sequence identity, or preferably being identical to SEQ ID NO: 1 (ssc-miR-205) and (ii) a miRNA having at least 90 % sequence identity, preferably having at least 95 % sequence identity, or being identical to SEQ ID NO: 2 (ssc-miR-128)
The Markush groups are improper because the alternatives defined by the Markush groups do not share both a single structural similarity and a common use for the following reasons:
It is first noted that MPEP 706.03(y) 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)). “ Members of a Markush group share a “single structural similarity” when they belong to the same recognized physical or chemical class or to the same art-recognized class (prong 1) and the members of a Markush group share a common function or use when they are disclosed in the specification or known in the art to be functionally equivalent (prong 2).
The phrase “significant structural element is shared by all of the alternatives” refers to cases where the compounds share a common chemical structure which occupies a large portion of their structures, or in case the compounds have in common only a small portion of their structures, the commonly shared structure constitutes a structurally distinctive portion in view of existing prior art, and the common structure is essential to the common property or activity.
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” (see MPEP 706.03(y)IIA).
Herein, the recited alternative species do not share a single structural similarity, as each miRNA has a different chemical structure in that it consists of a different nucleotide sequence. The only structural similarity present is that all of the miRNAs comprise nucleotides. The fact that the miRNAs comprise nucleotides per se does not support a conclusion that they have a common single structural similarity because the structure of comprising nucleotides alone is not essential to the asserted common activity of being correlated with a trichothecene effect. Accordingly, while the different miRNAs are asserted to have the property of being correlated with a trichothecene effect, they do not share a substantial structural similarity essential to this activity.
Further, the recited miRNAs do not belong to a chemical or art-recognized class because there is no expectation from the knowledge in the prior art that the miRNAs behave in the same manner and can be substituted for one another with the same intended result achieved. There is no evidence of record to establish that it is clear from their very nature that the recited miRNAs possess the common property of being correlated with a trichothecene effect.
Following this analysis, the claims are rejected as containing an improper Markush grouping.
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached on 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 1634
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