DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to the communication filed 10-31-25.
Claims 17, 19-31 are pending in the instant application.
Response to Arguments and Amendments
Withdrawn Objections/Rejections
Any objections or rejections not repeated in this Office action are hereby withdrawn.
Maintained Rejections
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 17, 19-23, 28, 29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims are drawn to compositions comprising mir-3184 and optionally further comprising let-7b, let-7c, miR-19b, miR-22, miR-24, miR-25, miR-29a, miR-30a, miR-92a, miR-99a, miR-100, miR-197, miR-30d, miR-181a, miR-181b, miR-205, miR-210, miR-221, miR-125b, miR-125a, miR-149, miR-193a, miR-320a, miR-200a, miR-99b, miR-130b, miR-30e, miR-375, miR-378a, miR-151a, miR-425, miR-484, miR-146b, miR-574, miR-652, miR-320c, miR-3141, let-7d, miR-196a, miR-187, miR-516a, miR-92b, and miR-3126, let-7d, miR-196a, miR-187, miR-516a, miR-92b, miR-3126, miR-3141 and/or miR-3126.
Applicant’s Arguments
Applicant's arguments filed 10-31-25 have been fully considered but they are not persuasive. Applicant argues the following:
Applicant has amended the present claims to recite that the nutritional composition is in a form selected from the group consisting of an infant formula and a fortifier, and wherein the nutritional composition is not natural human or animal milk. Applicant respectfully submits that the present claims include additional elements that amount to significantly more than the judicial exception and are not directed to naturally occurring products.
Response to Applicant’s Arguments
Contrary to Applicant’s assertions, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the nucleic acids claimed have little or no difference from naturally occurring products. The claims do not include any elements that add significantly more to any judicial exceptions, and does not include features that demonstrate that the recited products are markedly different from what exists in nature (e.g, there are no covalent or other modifications to the miR molecules). Therefore, the claims of miR molecules amount to nothing more than obvious derivatives of natural occurring products and steps intending to utilize them to treat a condition or disease.
The claimed invention is directed to compositions in combinations with naturally occurring nucleic acid molecules, whether isolated or not, that are not patent eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc. (6-13-13).
For these reasons, the instant rejection is properly maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 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 24-27, 30 and 31 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for an in vitro Caco2 cell model for evaluating the effect of miR-3184-3p, miR-3126-5p, and miR-3141 on gene expression, does not reasonably enable methods of promoting healthy growth and development and preventing any metabolic disorders later in life in any subject comprising administering a nutritional composition comprising miR-3184, or methods to modulate gene expression of one or more genes selected from Lipin 2 and Insulin Like Growth Factor 2 using miR-3184. 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.
Applicant’s Arguments
Applicant's arguments filed 10-31-25 have been fully considered but they are not persuasive. Applicant argues the following:
Applicant respectfully disagrees. In this regard, the enablement requirement may be met by animal tests or in vitro data, and an in vitro model example constitutes a working example if that example correlates with a disclosed or claimed method.⁴ Applicant notes that "a rigorous or an invariable exact correlation is not required."⁵ The Examples of the present disclosure include data from a Caco2 in vitro cell model to evaluate the effect of miR-3184 on gene expression.⁶ As can be seen in Table 4, miR-3184 significantly affected the expression of Lipin 2 and IGF2. Therefore, the cell model disclosed in the present specification provides
See Specification, Example 2 - In Vitro Evaluation of miR-3184. enablement for the method to modulate gene expression of one or more genes selected from: Lipin 2 or Insulin Like Growth Factor 2.
Moreover, the present specification discloses that Lipin-2 and IGF2 "have a role in regulation of lipid metabolism and adequate growth, respectively." For example, the specification explains that "IGF-2 is necessary for adequate human growth," and "[t]here is a body of evidence on the relationship of IGF-2 with weight and adiposity in infants." The present specification also states that "Lipin 2 plays important roles in controlling the metabolism of fatty acids at different levels. Therefore, the modulation of the expression of Lipin and IGF2 are directly correlated with promoting healthy growth and development and preventing metabolic disorders later in life in a subject.
The Examiner has not provided any evidence that the model disclosed in the present specification does not correlate with the claimed methods. Therefore, the examples disclosed in the specification provide enablement for the present claims
Response to Applicant’s Arguments
The claims are drawn to methods of promoting healthy growth and development and preventing any metabolic disorders later in life in any subject comprising administering a nutritional composition comprising miR-3184, and methods to modulate gene expression of one or more genes selected from Lipin 2 and Insulin Like Growth Factor 2 using miR-3184 in a subject.
The Teachings in the Specification:
As stated previously, the specification teaches the following:
Eleven dynamic miRNAs were identified with either an increasing or a decreasing expression during lactation. These are shown in Tables 1 and 2 below. Thirty-eight miRNAs were identified which were highly and stably expressed during lactation. These are shown in Table 3…
Cell culture and transfection Caco2 were cultured in DMEM (+) L-glutamate (-) Pyruvate supplemented with 1X non-essential amino acids, 1mM Sodium Pyruvate and 20 % FBS. Cells were split three times a week without exciding 80% confluency. For transfection, cells were plated in 24 well plate (50,000 cells / well) to obtain a 50% confluency the day after. Transfection was performed using DharmaFect reagent from Dharmacon… following manufacturer recommendation. Briefly, 1.25 ul / well of DharmaFect 4 and a final concentration of 25 nM of miRNA were used. For each time point (i.e. 48h and 72h post transfection) media was removed and cells were washed with 1 ml of cold PBS without calcium chloride and magnesium chloride. Cells were frozen directly on plate after aspirating cold PBS. miRNA were purchased from Dharmacon…, see P 33.
An in vitro Caco2 cell model was used to evaluate the effect of miR-3184-3p, miR-3126-5p, and miR-3141 on gene expression. miR-3184-3p, miR-3126-5p, and miR-3141 significantly effected the expression of the genes shown in Table 4…
Contrary to Applicant’s assertions, the examples provided in the instant specification, of an in vitro Caco2 cell model for evaluating the effect of miR-3184-3p, miR-3126-5p, and miR-3141 on gene expression, are not representative or correlative of the ability to provide methods of promoting healthy growth and development and preventing any metabolic disorders later in life in any subject comprising administering a nutritional composition comprising miR-3184, or to provide methods to modulate gene expression of one or more genes selected from Lipin 2 and Insulin Like Growth Factor 2 using miR-3184 in any subject. There is no teaching in the specification as to the stability of mIR molecules upon oral ingestion, and their ability to provide for in vivo effects as instantly claimed.
In light of the teachings in the art and the specification, one skilled in the art would not accept on its face the examples provided in the instant disclosure, and summarized above, as being correlative or representative of the ability to provide therapeutic effects in any subject as instantly claimed.
Since the specification fails to provide the requisite guidance for delivery and provision of therapeutic effects in a subject, and since determination of the factors required for accomplishing therapeutic efficacy in a subject is highly unpredictable, it would require undue experimentation to practice the invention over the broad scope claimed.
For the aforementioned reasons, the instant rejection under 35 U.S.C. 112, first paragraph is properly maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Certain papers related to this application may be submitted to Art Unit 1637 by facsimile transmission. The faxing of such papers must conform with the notices published in the Official Gazette, 1156 OG 61 (November 16, 1993) and 1157 OG 94 (December 28, 1993) (see 37 C.F.R. ' 1.6(d)). The official fax telephone number for the Group is 571-273-8300. NOTE: If Applicant does submit a paper by fax, the original signed copy should be retained by applicant or applicant's representative. NO DUPLICATE COPIES SHOULD BE SUBMITTED so as to avoid the processing of duplicate papers in the Office.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jane Zara whose telephone number is (571) 272-0765. The examiner’s office hours are generally Monday-Friday, 10:30am - 7pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jennifer Dunston, can be reached on (571)-272-2916. Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (703) 308-0196.
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Jane Zara
1-10-26
/JANE J ZARA/Primary Examiner, Art Unit 1637
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