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
This application claims to benefit from CN202310585653.X on filed May 23, 2023.
Election/Restrictions
Applicant’s election without traverse of group II (claims 9-15) in the reply filed on 08/04/2026 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)).
Claims 1-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/04/2026.
Status of the claims
Claims 1-15 are pending. Claims 9-15 are currently under examination.
Claim Objections
Claims 13-14 are objected to because of the following informalities: Claims 13 and 14 each recite the limitation “the step (iii)”. It is suggested that this limitation be amended to “step (iii)” to maintain claim clarity. Appropriate correction is required.
Claim 15 recites the limitation “with a primer for qPCR detection, and a sequence of the primer is as shown in at least one of SEQ ID NO: 16-SEQ ID NO: 27”. It is suggested that this limitation be amended to “is with a primer for qPCR detection and the nucleotide sequence of said primer is at least one of SEQ ID NO: 16 -SEQ ID NO: 27” to maintain claim clarity. Appropriate correction is required.
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 9-15 are rejected under 35 U.S.C. §101 because these claims are not directed to patent eligible subject matter. Based upon an analysis with respect to the claims as a whole, claim(s) 9-15 do not recite something significantly more than a judicial exception. The rationale for this determination is explained below:
According to the 2019 Revised Patent Subject Matter Eligibility Guidance, Docket No. PTO-P-2018-0053 (January 7, 2019), an initial two step analysis is required for determining statutory eligibility.
According to the Manual of Patent Examination Procedure (MPEP) sections 2103 through 2106.07(c), which now incorporates the 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG), October 2019 Patent Eligibility Guidance Update (October 2019 Update), and the Berkheimer Memo, an initial two step analysis is required for determining statutory eligibility.
Step 1
Step 1 requires a determination of whether the claims are directed to a process, machine, manufacture, or a composition of matter. In the instant case, the Step 1 requirement is satisfied as the claims are directed towards a process.
Step 2
The Step 2 analysis is a two-part analysis, Step 2A and Step 2B.
Step 2A, prong 1
Step 2A, prong 1 requires a determination of whether the claims are directed towards a judicial exception, i.e. a law of nature, natural phenomenon, or an abstract idea, while step 2A, prong 2 requires an analysis of whether the judicial exception integrated into a practical application if the claim recites a judicial exception under Prong 1.
Step 2A, prong 2
Step 2A, prong 2 requires an analysis of whether the judicial exception integrated into a practical application if the claim recites a judicial exception under Prong 1.
Step 2B
The second part, Step 2B of the two step analysis is drawn to determining whether any element or combination of elements, in the instant claims is/are sufficient to ensure that the claims as a whole amounts to significantly more than the judicial exception.
Following the analysis below the claims are not patent eligible under 35 U.S.C. 101.
Concerning Step 1: YES. Claims 9-15 are directed to methods, therefore the claims are directed to a process, which is a statutory category.
Concerning Step 2A: YES. Claims 9-15 recite methods of diagnosing the condition of a periparturient dairy cow comprising comparing the relative expression of at least one miRNA selected from SEQ ID NO: 1-14, with one or more reference values to determine the condition of a periparturient dairy cow. Claims 9-15 rely on a naturally-occurring correlation between naturally occurring expression amounts of one or more exosomal miRNA consisting of SEQ ID NO: 1-14 in periparturient dairy cow(s) and the presence of fatty liver disease. Accordingly, claims 9-15 are directed towards a judicial exception, i.e. a law of nature.
Concerning Step 2A, prong 1, As noted above, claims 9-15 are directed to towards a judicial exception, i.e. a law of nature. Claims 9-15 also recite abstract ideas of comparing expression values and diagnosing fatty liver disease based on relative exosome miRNA expression levels.
The comparing, diagnosing fatty liver disease and determining the conditions of a periparturient dairy cow are steps fall within the “Mental processes” grouping of abstract ideas and as they merely instruct a user to analyze changes of quantities of miRNA expression amounts (analyze the natural law) and to draw a conclusion.
Concerning Step 2A, prong 2, the judicial exception of claims 9-15 are not integrated into a practical application because of the following.
A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception. When the exception is so integrated, then the claim is not directed to a judicial exception.
Claims 9-15 do not recite steps/elements that are construed to be a practical application that apply, rely on, or use the judicial exceptions. The steps of serum collection including exosome enrichment and performing a real-time fluorescence quantitative PCR are not practical applications as they must be applied to realize the judicial exception(s).
They are also recited with a high level of generality and therefore do not add any meaningful limitation to practicing the natural law and/or abstract idea.
Concerning Step 2B, claims 9-15 do not recite any additional elements that ensure that the claims as a whole amount to significantly more than the judicial exception(s).
There is no inventive concept in claims 9-15, and thus they are rejected as being ineligible under 35 U.S.C. 101.
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 9-15 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 9-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite as claims 9-10 and 12 recites the limitation “miRNA as shown in” and claims 11-15 each recite the limitation “miRNAs as shown in”. Claim 15 further recites the limitation “the primer is as shown in”.
The noted limitations lack clarity concerning whether the full length or a partial nucleotide sequence is meant by the term “as shown in” in the limitations. It is suggested that conventional U.S. claim language such as “comprising” or “consisting of” be used in place of the phrase “as shown in” of the limitation to maintain clarity of the scope of the claimed sequences.
Claim 10 recites the limitation, “iv) comparing the relative expression with an expression level of the healthy cow, and when the trend of changes in the suspected cow or the cow to be diagnosed is an increased expression, or a decreased expression,
the suspected cow or the cow to be diagnosed is diagnosed to be a periparturient dairy cow with the fatty liver; wherein the trend of changes is an increased expression when log2(FC)>0 and is a decreased expression when log2(FC)<0, FC stands for Fold Change”, which is confusing and this, indefinite.
It is unclear whether this limitation directs a diagnosis that a periparturient dairy cow has fatty liver disease when one or more miRNA selected from SEQ ID NO: 1-12 shows increased expression or a decreased expression relative to the expression level of the one or more miRNA of a healthy cow.
It is unclear whether this limitation should be construed as reciting that an increased expression is detected when log2(fold change)>0 and a decreased expression is detected when log2(fold change)<0.
Claims 11-15 are further rejected as they depend from claim 10.
Claim 12 recites the limitations “wherein the periparturient dairy cow is recorded as A” and “wherein the any one of the other periparturient dairy cows is recorded as B”, which are all confusing when claim 12 is considered as whole, thus rendering claim 12 indefinite. Amendment of claim 12 is required.
Concerning the limitation of claim 12 as follows:
“when the trend of changes is an increased expression when log2(FC)>0, the periparturient dairy cow recorded as A is a periparturient dairy cow with high-grade fatty liver; and
for the exosome miRNA as shown in SEQ ID NO: 9 and/or SEQ ID NO: 10, when the trend of changes is an increased expression when log2(FC)<0, the periparturient dairy cow recorded as A is a periparturient dairy cow with mid -grade fatty liver”.
This limitation is also found to lack clarity and clarity of scope.
It is unclear whether this limitation claim 12 directs a comparison of the expression level detected for an exosomal miRNA SEQ ID NO: 9 or exosomal miRNA SEQ ID NO: 10 from an individual cow to the exosomal miRNA SEQ ID NO: 12.
It is unclear whether the limitation identifies a periparturient dairy cow with high-grade fatty liver as the cow in which increased relative expression of SEQ ID NO: 12 is detected over that of SEQ ID NO: 9 and/or 10 and the increased expression is from detecting log2(fold change) >0.
It is unclear whether the limitation identifies a periparturient dairy cow with mid-grade fatty liver as the cow in which increased relative expression of SEQ ID NO: 12 is detected over that of SEQ ID NO: 9 and/or 10 and the increased expression is from detecting log2(fold change) < 0.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12 depends from claim 11 and is drawn a method is drawn to detecting the relative expression of an exosome miRNA combination consisting SEQ ID NOS: 9, 10 and 12 to distinguish mid-grade fatty liver and high-grade fatty liver in periparturient dairy cows.
Claim 12 does not appear to be further limiting of claim 11 as claim 11 is directed to detecting the relative expression of an exosome miRNA combination consisting SEQ ID NOS: 3-5, 7-8 and 11 to distinguish periparturient dairy cows with fatty liver and health dairy cows. The exosome miRNA combination of claim 11 and claim 12 are distinct and it is not clear if claim 12 is drawn to an additional step that provides a new exosome miRNA combination to identify mid-grade fatty liver and high-grade fatty liver in periparturient dairy cows after periparturient dairy cows with fatty liver are detected using the exosome miRNA combination consisting SEQ ID NOS: 9, 10 and 12.
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.
Claims 9-10 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN105420405B (pub. Dec 07, 2018, English Translation of CN105420405B, pp.1-8 is cited below).
Regarding claims 9-10 and 15, CN105420405B teach method for diagnosing the condition of a periparturient dairy cow (entire document: see also pg 2, 1st para of section entitled Technical field and pg 2, section entitled “Summary of the invention”).
CN105420405B teach (1) detecting the relative expression of a miRNA (miR-27a-3p) consisting SEQ ID NO: 10 (see pg 3 of the EnglishTranslation_CN105420405B: wherein CN105420405B teach screening the molecular marker miR-27a-3p having the number MIMAT0000799 and the nucleotide sequence consisting SEQ ID NO: 15).
CN105420405B teach a primer for screening molecular marker miR-27a-3p-F has the nucleotide sequence consisting SEQ ID NO: 25 (pg 4, line 5).
CN105420405B teach a qpCR assay to detect nine cow serum miRNAs (miR-27a-3p, miR-21-3p, miR-378a-3p, miR-122-5p, miR-29c-3p, miR-16-5p, miR-33-5p, miR-194-5p, and miR-145-5p) in fatty liver and normal liver cow group and using cel-miR-39-3p as internal reference gene and detected decreased relative expression of miR-16-5p and miR-29c-3p in fatty liver cows compared to normal liver milk cows (see pg 4 and see also pg 6, text of section entitled 3. qRT-PCR).
Accordingly, the instant claims 9-10 and 15 are anticipated by CN105420405B.
Conclusion
No claims are currently allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLAYINKA A OYEYEMI whose telephone number is (571)270-5956. The examiner can normally be reached Monday -Thursday: 9:00 am - 5:00 pm, EST.
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OLAYINKA A. OYEYEMI
Examiner
Art Unit 1681
/OLAYINKA A OYEYEMI/Examiner, Art Unit 1681
/GARY BENZION/Supervisory Patent Examiner, Art Unit 1681
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