DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on November 30th, 2023, June 10th, 2024, and September 10th, 2024 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9 and 16-17, in the reply filed on May 4th, 2026 is acknowledged.
Claims 10-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 May 4th, 2026.
After further consideration, the corresponding species election for invention I consisting of an election from SEQ ID NOs: 1-13 is withdrawn. All SEQ IDs in claims 2 and 3 will be considered.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Summary
Claims 1-17 are pending. Claims 10-15 are withdrawn from consideration as being drawn to a non-elected invention/species. Claims 1-9 and 16-17 are under examination and discussed in this Office action.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c). Please see Tables 1, 2, and 4, where sequences are presented with a “No.” column that consists of just numbers, not sequence identifiers (i.e., “SEQ ID NO:X” or the like).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Specification
The use of the terms such as NucleoSpin, PureLink, and miRCURY LNA, which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Interpretation
Claims 1, 7, 16, and 17 refer to “a test body”. Turning to the specification, it is described that “test body” is used interchangeably with “sample” and “test sample”. Thus, the claim has been given the broadest reasonable interpretation consistent with the teachings of the specification regarding a “test body” (In re Hyatt, 211 F.3d1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000) (see MPEP 2111).
Claim Rejections - 35 USC § 112(b)
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 2, 3, 6, and 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2 and 3 recite the limitation “one or several additions at a site, or a corresponding site to the site, other than a characterizing site that characterizes a wild type and mutant type of interest of each of these sequences, and a complementary sequence thereof” in relation to variations that may be included in the claimed SEQ IDs. It is unclear from this recitation what “a site”, “a corresponding site to the site”, and “a characterizing site that characterizes a wild type and mutant type of interest of each of these sequences” are meant to be describing. “A site” has not been further described and it is therefore unclear if this is intended to be a specific site in each of the SEQ IDs or if it is a generic site, such as the 3’ or 5’ end of the SEQ IDs. Because this site has not been described, it is also unclear what “a corresponding site” to this site could be for each of the SEQ IDs. Finally, “a characterizing site that characterizes a wild type and mutant type of interest of each of these sequences” has not been further described and it is therefore unclear if this characterizing site is meant to be a specific site in each of the SEQ IDs or if it is a generic site, such as the 3’ or 5’ end of the SEQ IDs. Therefore, claims 2 and 3 are found indefinite.
Claim 6 recites the limitation "wherein the mutation is a 1 base substitution" in. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 6 depends, does not introduce “a mutation”, but instead “mutation-specific concentration” with no specific recitation related to a mutation. Therefore, claim 6 is found indefinite.
Claim 8 recites the limitation "wherein the cancer is at least one cancer selected from the group consisting of breast cancer and pancreatic cancer". There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 8 depends, does not introduce “a cancer”, but instead “a cancer test body” and “a non-cancer test body” with no specific recitation related to a cancer. Therefore, claim 8 is found indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 and 16-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon and abstract ideas without significantly more. While the claims are directed to a process, and therefore meet step 1 of the subject matter eligibility test (see MPEP 2106.03), the claims recite the natural correlation between mutation-specific concentrations of miRNAs and determining cancer. Such correlation is a natural phenomenon because it describes a consequence of natural processes in the human body. The claims also recite the mental processes of determining whether a test body is a cancer test body or non-cancer test body, or determining a possibility that a subject has cancer. Such mental processes are abstract ideas because they can reasonably be performed in the human mind.
Step 2A of the subject matter eligibility test requires a two-pronged analysis. Prong One asks: does the claim recite an abstract idea, law of nature or natural phenomenon? As discussed in MPEP 2106.04(II)(A)(1), the meaning of “recites” is “set forth” or “describes”. That is, a claim recites a judicial exception when the judicial exception is “set forth” or “described” in the claim. In the instant case, the claims describe a natural phenomenon and abstract ideas: the natural correlation between mutation-specific concentrations of miRNAs and determining cancer, and the mental processes of determining whether a test body is a cancer test body or non-cancer test body, or determining a possibility that a subject has cancer.
Prong Two of the analysis under step 2A asks: does the claim recite additional elements that integrate the judicial exception into a practical application of the judicial exception? As discussed in MPEP 2106.04(II)(A)(2), “Because a judicial exception is not eligible subject matter, Bilski, 561 U.S. at 601, 95 USPQ2d at 1005-06 (quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)), if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application. See, e.g., RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"); Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016) (eligibility "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself."). For a claim reciting a judicial exception to be eligible, the additional elements (if any) in the claim must "transform the nature of the claim" into a patent-eligible application of the judicial exception, Alice Corp., 573 U.S. at 217, 110 USPQ2d at 1981, either at Prong Two or in Step 2B.” The considerations to be used are set forth at MPEP 2106.05(a) through (c) and (e) through (h). Turning to those sections of the MPEP:
MPEP 2106.05(a) has to do with improvements to the functioning of a computer or to any other technology or technical field. The claims at issue do not improve the functioning of a computer or other technology. While the instant claims recite steps of measuring mutation-specific concentration of at least one miRNA, with options of specific miRNA SEQ IDs; correcting a value of the mutation-specific concentration; determining whether the test body is a cancer test body or a non-cancer test body using an increase or decrease in the obtained corrected mutation-specific concentration as an index, or determining a possibility that a subject has cancer or a risk of developing cancer using an increase or decrease in the obtained corrected mutation-specific concentration as an index; performing correction by multiplying a normalized value of a total number of aligned reads by frequency information or dividing by an internal standard; determine increase or decrease in the resulting corrected mutation-specific concentration by a predetermined threshold; wherein the mutation is a 1 base substitution; wherein the test body is serum or plasma; wherein the cancer is breast cancer or pancreatic cancer; and the measuring is performed by an NGS method, a PCR method, or a microarray method, the claims do not improve upon miRNA measuring techniques or value correction techniques. The claims merely use existing methods for these steps. Note that MPEP 2106.05(a) indicates that “[u]sing well-known standard laboratory techniques to detect enzyme levels in a bodily sample” is an example that the courts have indicated may not be sufficient to show an improvement to technology.
MPEP 2106.05(b) has to do with whether the claims involve the use of a particular machine. In this case, the claims do not involve the use of a particular machine. While the instant claims recite steps of measuring mutation-specific concentration of at least one miRNA, with options of specific miRNA SEQ IDs; correcting a value of the mutation-specific concentration; determining whether the test body is a cancer test body or a non-cancer test body using an increase or decrease in the obtained corrected mutation-specific concentration as an index, or determining a possibility that a subject has cancer or a risk of developing cancer using an increase or decrease in the obtained corrected mutation-specific concentration as an index; performing correction by multiplying a normalized value of a total number of aligned reads by frequency information or dividing by an internal standard; determine increase or decrease in the resulting corrected mutation-specific concentration by a predetermined threshold; wherein the mutation is a 1 base substitution; wherein the test body is serum or plasma; wherein the cancer is breast cancer or pancreatic cancer; and the measuring is performed by an NGS method, a PCR method, or a microarray method, no such machines are required by the claim, and certainly no particular machines. Even if some conventional machine were recited in the claims, such as a PCR machine, further considerations such as the particularity or generality of the recited machine must be taken into account, as well as whether the involvement of the machine is merely extra-solution activity. MPEP 2106.05(g) describes “extra-solution activity”, noting that “[d]etermining the level of a biomarker in blood” is an example of “mere data gathering” which the courts have found to be insignificant extra-solution activity.
MPEP 2106.05(c) has to do with whether the claims involve a particular transformation. Here, none of the limitations of the claims involve a particular transformation. For example, measuring concentration of an miRNA does not transform that miRNA into something else.
MPEP 2106.05(e) has to do with “other meaningful limitations”. The additional limitations imposed upon the natural correlation between mutation-specific concentrations of miRNAs and determining cancer, and the mental processes of determining whether a test body is a cancer test body or non-cancer test body, or determining a possibility that a subject has cancer in the instant case have to do with measuring mutation-specific concentration of at least one miRNA, with options of specific miRNA SEQ IDs; correcting a value of the mutation-specific concentration; performing correction by multiplying a normalized value of a total number of aligned reads by frequency information or dividing by an internal standard; determine increase or decrease in the resulting corrected mutation-specific concentration by a predetermined threshold; wherein the mutation is a 1 base substitution; wherein the test body is serum or plasma; wherein the cancer is breast cancer or pancreatic cancer; and the measuring is performed by an NGS method, a PCR method, or a microarray method. These limitations are not considered “meaningful limitations”. MPEP 2106.05(e) states: “The phrase "meaningful limitations" has been used by the courts even before Alice and Mayo in various contexts to describe additional elements that provide an inventive concept to the claim as a whole.” However, as will be discussed below, these limitations do not arrive at an inventive concept. In addition, as has been discussed, they represent insignificant extra-solution activity, i.e. “data gathering”.
MPEP 2106.05(f) raises the question as to whether the additional elements recited in the claim represent “mere instructions to apply an exception”. Here, the judicial exceptions are the natural correlation between mutation-specific concentrations of miRNAs and determining cancer, and the mental processes of determining whether a test body is a cancer test body or non-cancer test body, or determining a possibility that a subject has cancer. The additional elements recited in the claims (i.e. measuring mutation-specific concentration of at least one miRNA, with options of specific miRNA SEQ IDs; correcting a value of the mutation-specific concentration; performing correction by multiplying a normalized value of a total number of aligned reads by frequency information or dividing by an internal standard; determine increase or decrease in the resulting corrected mutation-specific concentration by a predetermined threshold; wherein the mutation is a 1 base substitution; wherein the test body is serum or plasma; wherein the cancer is breast cancer or pancreatic cancer; and the measuring is performed by an NGS method, a PCR method, or a microarray method) does amount to mere instructions to apply the correlation, since measuring concentration of miRNAs, correcting concentration values, particular mutations, particular samples, particular cancers, and particular measuring techniques serve as mere conventional steps taken for the purpose of gathering data about the miRNA concentrations in a subject, which any practical use of the judicial exceptions would require.
MPEP 2106.05(g) has to do with whether the additional elements of the claim amount to insignificant extra-solution activity. MPEP 2106.05(g) notes that “[d]etermining the level of a biomarker in blood” is an example of “mere data gathering” which the courts have found to be insignificant extra - solution activity. Likewise, MPEP 2106.05(g) notes that “[p]erforming clinical tests on individuals to obtain input for an equation” also represents insignificant extra-solution activity. This aligns closely with the instant claims, where the additional elements of the claims amount to measuring miRNA concentration, correcting a value of the concentration, and additional specifics related to sample types and mutations.
MPEP 2106.05(h) has to do with whether the additional elements amount to more than generally linking the use of a judicial exception to a particular technological environment or field of use. Here, the recitation of the method identifies features of a test body and a microRNA cancer marker is considered a “field of use”. However, as MPEP 2106.05(h) indications, such limiting to a particular “field of use” does not confer patentability on otherwise ineligible subject matter.
In addition, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception (as set forth in step 2B of the subject matter eligibility test; see MPEP 2106-III) because it was routine and conventional in the prior art to measure miRNA concentration and normalize the concentration values, as well as specifics related to normalization, mutations, samples, cancers, and measuring techniques.
For example, Umansky (US 20140256562 A1) teaches a method of identifying a feature of a test body, comprising: measuring a concentration of at least one type of miRNA contained in the test body (Page 4, paragraph [0055]); correcting a value of the concentration in order to standardize data and acquiring the corrected concentration (Page 4, paragraph [0055]); and determining whether the test body is a cancer test body or a non-cancer test body, or determining a possibility that a subject has cancer or a risk of developing cancer, using a predetermined range in the obtained corrected concentration as an index (Page 4, paragraph [0055]). Umansky further teaches embodiments of the method wherein a subject is afflicted with a pathology of a cell or tissue when ratios of levels of miRNAs in cells or tissues of interest are higher than the corresponding control when normalized (Page 4, paragraph [0043]; Page 4, paragraph [0048]). Umansky further teaches wherein the correction to the mutation-specific concentration is performed by dividing by an internal standard (Page 4, paragraph [0055]). Umansky further teaches wherein the increase or decrease in the resulting corrected mutation-specific concentration is determined by a predetermined threshold (Page 4, paragraph [0055]). Umansky further teaches wherein the test body is serum or plasma (Page 6, paragraph [0075]). Umansky further teaches wherein the measuring is performed by a PCR method (Page 6, paragraph [0076]; Pages 16-17, paragraph [0206]; Page 17, paragraph [0209]).
Zelli (Emerging Role of isomiRs in Cancer: State of the Art and Recent Advances, Genes, September 2021, 12, 1-21) teaches that mature miRNA can have mutations (Page 3, paragraph 4; Figure 1). Zelli further teaches that these mutations can be associated with cancer (Page 7, paragraphs 2-5; Table 1). Zelli further teaches wherein the mutation is a 1 base substitution (Figure 1). Zelli further teaches wherein the cancer is breast cancer (Table 1; Pages 9-11, Breast Cancer).
Therefore, the additional elements beyond the identified judicial exceptions do not represent an inventive concept since measuring miRNA concentration and normalizing the concentration values, as well as specifics related to normalization, mutations, samples, cancers, and measuring techniques were routine, well-known and conventional.
Having considered the factors discussed in MPEP 2106.04(c)(II) and MPEP 2106.05 (a)-(c) and (e)-(h), as well as the prior art of Umansky and Zelli, it is clear that the additional elements recited in the claims, whether considered individually or as a combination, do not integrate the judicial exception into a practical application of that exception in such a way as to provide meaningful limits on the use of the judicial exception. Therefore, claims 1-9 and 16-17 are rejected here under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-9, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Umansky (US 20140256562 A1; cited on the IDS filed November 30th, 2023), in view of Zelli (Emerging Role of isomiRs in Cancer: State of the Art and Recent Advances, Genes, September 2021, 12, 1-21).
Regarding instant claim 1, Umansky teaches a method of identifying a feature of a test body, comprising: measuring a concentration of at least one type of miRNA contained in the test body (Page 4, paragraph [0055]); correcting a value of the concentration in order to standardize data and acquiring the corrected concentration (Page 4, paragraph [0055]); and determining whether the test body is a cancer test body or a non-cancer test body using a predetermined range in the obtained corrected concentration as an index (Page 4, paragraph [0055]).
Umansky does not teach determining whether the test body is a cancer test body or a non-cancer test body using an increase or decrease in the obtained corrected concentration as an index as it relates to identifying cancer in the above cited embodiment. However, Umansky does teach further embodiments of the method wherein a subject is afflicted with a pathology of a cell or tissue when ratios of levels of miRNAs in cells or tissues of interest are higher than the corresponding control when normalized (Page 4, paragraph [0043]; Page 4, paragraph [0048]). Therefore, it would be obvious to use this variation of the method for identifying cancer.
Umansky does not teach wherein the miRNA is a mutation-specific miRNA.
Zelli, in a reasonably pertinent field, teaches that mature miRNA can have mutations (Page 3, paragraph 4; Figure 1). Zelli further teaches that these mutations can be associated with cancer (Page 7, paragraphs 2-5; Table 1).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the miRNAs of Umansky with the miRNAs that have mutations of Zelli. Since Zelli teaches on miRNAs, which is reasonably pertinent to the method of Umansky, one of ordinary skill in the art would combine the two teachings with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to make this modification because “isomiRs likely play a role in the pathogenesis and progression of different cancer types and could also contribute to cancer molecular heterogeneity. A further element of interest is the promising use of isomiRs as cancer diagnostic and prognostic biomarkers” (Zelli, Page 7, paragraph 4), and further “isomiRs expression was proven to be superior compared to miRNAs expression in the classification of these different cancer types” (Zelli, Page 7, paragraph 4).
Regarding instant claim 4, Umansky, in view of Zelli, teaches the method according to claim 1. Umansky further teaches wherein the correction to the mutation-specific concentration is performed by dividing by an internal standard (Page 4, paragraph [0055]).
Regarding instant claim 5, Umansky, in view of Zelli, teaches the method according to claim 4. Umansky further teaches wherein the increase or decrease in the resulting corrected mutation-specific concentration is determined by a predetermined threshold (Page 4, paragraph [0055]).
Regarding instant claim 6, Umansky, in view of Zelli, teaches the method according to claim 1. Zelli further teaches wherein the mutation is a 1 base substitution (Figure 1).
Regarding instant claim 7, Umansky, in view of Zelli, teaches the method according to claim 1. Umansky further teaches wherein the test body is serum or plasma (Page 6, paragraph [0075]).
Regarding instant claim 8, Umansky, in view of Zelli, teaches the method according to claim 1. Zelli further teaches wherein the cancer is breast cancer (Table 1; Pages 9-11, Breast Cancer).
Regarding instant claim 9, Umansky, in view of Zelli, teaches the method according to claim 1. Umansky further teaches wherein the measuring is performed by a PCR method (Page 6, paragraph [0076]; Pages 16-17, paragraph [0206]; Page 17, paragraph [0209]).
Regarding instant claim 16, Umansky teaches a method for identifying between a cancer subject and a healthy subject, the method comprising measuring a mutation-specific concentration of at least one type of miRNA contained in a test body (Page 4, paragraph [0055]); correcting the mutation-specific concentration to obtain a corrected mutation-specific concentration (Page 4, paragraph [0055]); and determining whether the test body is a cancer test body or a non-cancer test body using a predetermined range in the obtained corrected concentration as an index (Page 4, paragraph [0055]).
Umansky does not teach determining whether the test body is a cancer test body or a non-cancer test body using an increase or decrease in the obtained corrected concentration as an index as it relates to identifying cancer in the above cited embodiment. However, Umansky does teach further embodiments of the method wherein a subject is afflicted with a pathology of a cell or tissue when ratios of levels of miRNAs in cells or tissues of interest are higher than the corresponding control when normalized (Page 4, paragraph [0043]; Page 4, paragraph [0048]). Therefore, it would be obvious to use this variation of the method for identifying cancer.
Umansky does not teach wherein the miRNA is a mutation-specific miRNA.
Zelli, in a reasonably pertinent field, teaches that mature miRNA can have mutations (Page 3, paragraph 4; Figure 1). Zelli further teaches that these mutations can be associated with cancer (Page 7, paragraphs 2-5; Table 1).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the miRNAs of Umansky with the miRNAs that have mutations of Zelli. Since Zelli teaches on miRNAs, which is reasonably pertinent to the method of Umansky, one of ordinary skill in the art would combine the two teachings with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to make this modification because “isomiRs likely play a role in the pathogenesis and progression of different cancer types and could also contribute to cancer molecular heterogeneity. A further element of interest is the promising use of isomiRs as cancer diagnostic and prognostic biomarkers” (Zelli, Page 7, paragraph 4), and further “isomiRs expression was proven to be superior compared to miRNAs expression in the classification of these different cancer types” (Zelli, Page 7, paragraph 4).
Regarding instant claim 17, Umansky teaches a method for identifying between a cancer subject and a healthy subject, the method comprising measuring a mutation-specific concentration of at least one type of miRNA contained in a test body derived from a subject (Page 4, paragraph [0055]); correcting the mutation-specific concentration to obtain a corrected mutation-specific concentration (Page 4, paragraph [0055]); and determining a possibility that a subject has cancer using a predetermined range in the obtained corrected concentration as an index (Page 4, paragraph [0055]).
Umansky does not teach determining a possibility that a subject has cancer using an increase or decrease in the obtained corrected concentration as an index as it relates to identifying cancer in the above cited embodiment. However, Umansky does teach further embodiments of the method wherein a subject is afflicted with a pathology of a cell or tissue when ratios of levels of miRNAs in cells or tissues of interest are higher than the corresponding control when normalized (Page 4, paragraph [0043]; Page 4, paragraph [0048]). Therefore, it would be obvious to use this variation of the method for identifying cancer.
Umansky does not teach wherein the miRNA is a mutation-specific miRNA.
Zelli, in a reasonably pertinent field, teaches that mature miRNA can have mutations (Page 3, paragraph 4; Figure 1). Zelli further teaches that these mutations can be associated with cancer (Page 7, paragraphs 2-5; Table 1).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the miRNAs of Umansky with the miRNAs that have mutations of Zelli. Since Zelli teaches on miRNAs, which is reasonably pertinent to the method of Umansky, one of ordinary skill in the art would combine the two teachings with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to make this modification because “isomiRs likely play a role in the pathogenesis and progression of different cancer types and could also contribute to cancer molecular heterogeneity. A further element of interest is the promising use of isomiRs as cancer diagnostic and prognostic biomarkers” (Zelli, Page 7, paragraph 4), and further “isomiRs expression was proven to be superior compared to miRNAs expression in the classification of these different cancer types” (Zelli, Page 7, paragraph 4).
Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rigoutsos (US 20170009295 A1) teaches on use of human miRNAs for diagnosis of human conditions and disease (Abstract), one of which is cancer (Page 3, paragraph [0017]). Rigoutsos also teaches on SEQ ID NOs: 7, 9, and 11-13 amongst their own sequences (see Sequence listing access at the end of Rigoutsos specification). However, Rigoutsos does not teach any specific miRNA in relation to cancer, broadly teaching that any one or more their miRNAs selected from SEQ ID NO:1 to SEQ ID NO: 47972 may be detected in relation to any of their taught conditions (Page 4, paragraph [0031]; Page 5, paragraph [0038]). Therefore, it is not obvious or suggested that any particular miRNA or SEQ ID is reasonably associated with cancer.
Conclusion
All claims stand rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Allison E Schloop whose telephone number is (703)756-4597. The examiner can normally be reached Monday-Friday 8:30-5 ET.
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/ALLISON E SCHLOOP/Examiner, Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
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