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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any rejection or objection not reiterated in this Action is withdrawn.
Note this application has been assigned to a different examiner.
Claim Objections
Claims 4 and 8 are objected to because of the following informalities: these claims recite the antisense inhibitor of miR451a comprises SEQ ID NO: 1, however this sequence is actually miR 451a itself, not the complement. Applicant may correct this informality by amending the claims to recite the inhibitor is the complement of SEQ ID NO: 1. Alternatively, applicant may submit a new sequence listing with the actual sequence of the inhibitor and recite that sequence identifier in the claims. The examiner notes this would not constitute new matter because the specification as filed provides implicit support for this sequence. Appropriate correction is required.
For the purposes of search and examination these claims are interpreted as if they recite the complement of SEQ ID NO: 1.
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 5 and 8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite(s) an inhibitor that is an antisense nucleic acid to miR451a. Since miRNAs bind to a complementary target mRNA sequence, a nucleic acid that is antisense to a miRNA will necessarily comprise that mRNA sequence fragment and is thus a fragment of a naturally occurring nucleic acid. This judicial exception is not integrated into a practical application and does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite only the nucleic acid.
The examiner notes there are a few options available to applicant to overcome this rejection, including amending the claims to recite the sequence comprises chemical modifications such as those contemplated on pages 22-25 of the specification, amending the claims to recite the sequence is in a vector, or adding additional elements to the composition (e.g., additional therapeutic agents or claiming a specific formulation/dosage form of the composition).
Claim Rejections - 35 USC § 102
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 5 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anand et al. (WO 2018/129402).
Anand et al. disclose an antisense nucleic acid to miR451a, see page 41, lines 8 and figure 3 and its description at page 4, lines 3-10. The recitation of “for treating endometriosis” is a recitation of intended use that does not provide patentable weight since the structure of the antisense disclosed by Anand et al. is identical to the claimed inhibitor.
Allowable Subject Matter
Claim 1 is allowed.
The following is an examiner’s statement of reasons for allowance: the closest prior art is Anand et al. While this document teaches an antisense inhibitor of miR451a, the prior art does not teach or fairly suggest that inhibition of this miRNA will provide a treatment for endometriosis.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tracy Vivlemore whose telephone number is (571)272-2914. The examiner can normally be reached Mon-Fri 7:30-4:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yvonne Eyler can be reached at 571-272-1200. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Tracy Vivlemore
Supervisory Primary Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
