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 .
Priority
The instant application was filed 09/16/2024 and is a national stage entry of PCT/EP2023/056573 with an international filing date: 03/15/2023 and claims foreign priority to DE10 2022 106 198.1, filed 03/16/2022. The file wrapper has a certified copy of the foreign priority document. However it is not in English. Thus the application is being given priority to the international filing date.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/16/2024 is being considered by the examiner.
Non-patent literature item 4 is marked through as it does not provide a date.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code.(page 12, lines 16; page 14, 18-19 for example) 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 Objections
Claims 1-15 are objected to because of the following informalities:
Claim 1 is objected to as it recites “HMGA2” but does not recite the full terminology for the acronym (or abbreviation). Claims are more concise when the first time an acronym (or abbreviation) is presented the full terminology is also presented. Finally an acronym (or abbreviation) may have alternative meanings to an artisan.
Claim 2 is objected to as it recites “ADIPOQ” but does not recite the full terminology for the acronym (or abbreviation). Claims are more concise when the first time an acronym (or abbreviation) is presented the full terminology is also presented. Finally an acronym (or abbreviation) may have alternative meanings to an artisan.
Claim 3 is objected to as it recites “PPAR-gamma and IL-6” but does not recite the full terminology for the acronym (or abbreviation). Claims are more concise when the first time an acronym (or abbreviation) is presented the full terminology is also presented. Finally an acronym (or abbreviation) may have alternative meanings to an artisan.
Claim 4 is objected to as it recites “BMI,” FIB4,” and “HbA1c” ” but does not recite the full terminology for the acronym (or abbreviation). Claims are more concise when the first time an acronym (or abbreviation) is presented the full terminology is also presented. Finally an acronym (or abbreviation) may have alternative meanings to an artisan.
Claim 8 objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from two or more claims. See MPEP § 608.01(n). Accordingly, the claim 8 is not been further treated on the merits.
Claim 10 is objected to as it recites “NAFLD and NASH” but does not recite the full terminology for the acronym (or abbreviation). Claims are more concise when the first time an acronym (or abbreviation) is presented the full terminology is also presented. Finally an acronym (or abbreviation) may have alternative meanings to an artisan.
Claim 14 is objected to as it recites “NAFLD and NASH” but does not recite the full terminology for the acronym (or abbreviation). Claims are more concise when the first time an acronym (or abbreviation) is presented the full terminology is also presented. Finally an acronym (or abbreviation) may have alternative meanings to an artisan.
Claim 15 objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from two or more claims. See MPEP § 608.01(n). Accordingly, the claim 15 is not been further treated on the merits.
Claim 15 is objected to as it recites “HMGA2” but does not recite the full terminology for the acronym (or abbreviation). Claims are more concise when the first time an acronym (or abbreviation) is presented the full terminology is also presented. Finally an acronym (or abbreviation) may have alternative meanings to an artisan
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-7, 9-14 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
. Claim 1-7, 9-14 are indefinite because the claims do not recite the basic steps of the claimed invention in a positive, active fashion (see Ex parte Erlich 3 USPQ2d, 1011). The claims recite, “the use,” but the claim fails to recite any actual steps that define the method. Thus the metes and bounds are unclear if the claims are to a composition or method.
Claim 1 recites, “The use of the relative value of the gene expression level of the gene HMGA2 and/or of a gene, the expression of which statistically correlates with that of the gene HMGA2, in the prognosis and/or diagnosis of a fatty liver disease of a subject..” As detailed above the claim does not set forth any active steps and thus appears to be a composition. It is unclear how a composition “statistically correlates” or is a “relative value.”
Claim 2 recites, “wherein the relative value of the gene expression level of the gene HMGA2 and/or of a gene, the expression of which statistically correlates with that of the gene HMGA2, is related to the relative value of the gene expression level of the gene ADIPOQ and/or of a gene, the expression of which statistically correlates with that of the gene ADIPOQ..” As detailed above the claim does not set forth any active steps and thus appears to be a composition. It is unclear how a composition “statistically correlates” or is a “relative value.”
Claim 3 recites, “wherein additionally the relative value (i) of the gene expression level of the gene HMGA2 or (ii) of the gene HMGA2 and of the gene ADIPOQ is related to the relative value of one gene expression level or preferably both gene expression levels of the genes selected from the group consisting of PPAR-gamma and IL-6...” As detailed above the claim does not set forth any active steps and thus appears to be a composition. It is unclear how a composition is a “relative value.”
Claim 7 recites, “the determination of the gene expression level or gene expression levels is done at the mRNA level.” The recitation of “dtermination” is not previously recited in the claim and thus lacks antecedent basis. Thus the claim is vague and unclear.
Claim 11 recites, “the onset of new liver fibrosis or the progression of pre-existing liver fibrosis, is made.” Neither claim 11 nor claim 1 previous require onset or progression. Thus the metes and bounds are unclear where these limitations find antecedent basis.
Claim 12 recites, “wherein the prognosis of deterioration of the state of the liver is related to the probability of type 2 diabetes remission.” Neither claim 12 nor the claims from which it depends previously recite, “prognosis of deterioration of the state of the liver” or “the probability of type 2 diabetes remission.” Thus the metes and bounds are unclear where these limitations find antecedent basis.
Claim 13 recites, “wherein the sample investigated is assigned to one of the following three risk clusters:C1: Increased probability of type 2 diabetes remission and reduced risk of liver fibrosis;C2: Increased probability of type 2 diabetes remission and increased risk of liver fibrosis;C3: Reduced probability of type 2 diabetes remission and reduced risk of liver fibrosis.” The claim does not previous recite “sample.” Further the claim is vague, unclear and incomplete how the sample is assigned to C1, C2, or C3.
Claim 14 recites, “the liver disease.” Neither claims 14 or claim 1 recite “liver disease.” Thus the metes and bounds are unclear.
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.
the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims are use claims and thus are not to one of statutory classes.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 7-14 is/are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Nerenberg (US2019/0071795).
Claims are drawn to the use of relative expression values of HMGA2, PPARGamma, ADIPQ. The claim provides no positive active steps and thus is being given the broadest reasonable interpretation as a composition.
With regards to claim 1, Nerenberg teach HMGA2 expression (table 1). Nerenberg teaches normalization of gene expression (0081, 0086). Thus Nerenberg teaches relative (normalized ) expression of the gene.
With regards to claim 2, Nerenberg teach ADPIQ expression (00170). Nerenberg teaches normalization of gene expression (0081, 0086) Thus Nerenberg teaches relative (normalized ) expression of the gene.
With regards to claim 3, Nerenberg teach PPARgamma expression (0127). Nerenberg teaches normalization of gene expression (0081, 0086) Thus Nerenberg teaches relative (normalized ) expression of the gene.
With regards to claim 4, Nerenberg teaches determining BMI (0092)
With regards to claim 7, Nerenberg teaches detection of MRNA (0137)
With regards to claim 9, Nerenberg teaches bariatric surgery (0090)
With regards to claim 10, 14Nerenberg teaches NAFLD and NASH (0090)
With regards to claim 11, Nerenberg teaches liver fibrosis (0183)
With regards to claim 12, Nerenberg teaches type II diabetes (0006)
Claim 13 is unclear how assigning is done. Thus the broadest reasonable interpretation is any type of assigning or diagnosis.
With regards to claim 13, Nerenberg teaches diagnosis (0071)
Claim(s) 1-2, 4-7 is/are rejected under 35 U.S.C. 102(a)(1)/ 102(a)(2) as being anticipated by Jensen (US20200377948).
Claims are drawn to the use of relative expression values of HMGA2, PPARGamma, ADIPQ. The claim provides no positive active steps and thus is being given the broadest reasonable interpretation as a composition.
With regards to claims 1-2, Jensen teaches, “[0051] I) lowered relative gene expression level for ADIPOQ, greatly increased relative gene expression level for HMGA” Thus Jensen anticipates the claims
With regards to claim 4, Jensen teaches, “0051] I) lowered relative gene expression level for ADIPOQ, greatly increased relative gene expression level for HMGA2 and also at least one of the marker situations selected from the group consisting of increased HbA1c blood values.”
With regards to claims 5-6, Jensen teaches, “Detection of the Expression of ADIPOQ and HMGA2 in Adipose Tissue Puncture Biopsies, Obtained by Fine-Needle Aspiration of Subcutaneous Abdominal Adipose Tissue” (0225)
With regards to claim 7, Jensen teaches, “[0010] The value for the relative gene expression level in the context of the present invention can be achieved in any manner known to a person skilled in the art. Preference is given to determining the gene expression level at the mRNA level or at the protein level. In this connection, the mRNA level is preferred.”
Summary
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN C POHNERT PhD whose telephone number is (571)272-3803. The examiner can normally be reached Monday- Friday about 6:00 AM-5:00 PM, every second Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571)272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Steven Pohnert/ Primary Examiner, Art Unit 1683
