DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 1-14 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.
Claim 1 recites hsa-miR-119a-3p of SEQ ID NO: 14. According to instant specification sequence of SEQ ID NO: 14 belongs to hsa-miR-199a-3p (see Table 1). Also, hsa-miR-119a-3p is not mentioned in the disclosure at all. For the purpose of examination it will be considered that hsa-miR-199a-3p is of SEQ ID NO: 14, but appropriate correction is required.
Claims 2-14 are rejected based on their dependency on claim 1.
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.
Claims 3, 11 are 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 3 depends on claim 1 and adds a limitation of microRNA mimics mimicking the function of any of SEQ ID NOs: 35, 10, 33, 31, 1, 29, 14. By definition microRNA mimics of claim 1 mimic the function of any of SEQ ID NOs: 35, 10, 33, 31, 1, 29, 14, thus claim 3 does not further limit claim 1.
Claim 11 depends on claim 10 and recites a number of ways to obtain a stretch of microRNAs from claim 10. The way of obtaining such stretch does not affect the structure of such stretch, thus claim 11 does not further limit claim 10.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-11, 13-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. The claim(s) recite(s) microRNA mimics, such mimics including microRNAs by themselves (see claim 12 which excludes such natural microRNAs from the genus of microRNA mimics). Such microRNAs are compositions of matter, therefore satisfying Step 1 of eligibility analysis. Specification defines microRNA mimics as any microRNA mimicking natural microRNA function (see paragraph [0142]). Therefore a genus of microRNA mimics include natural microRNAs by themselves. Synthetic microRNAs can be indistinguishable and not structurally different from natural microRNAs. Further, DNA encoding such microRNAs is claimed as well, which encompass natural DNA encoding natural microRNAs in any organism. Therefore, the claimed microRNA mimics and DNA encoding them include products of nature, satisfying Step 2A Prong One of eligibility analysis. Association for Molecular Pathologyv. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013) (naturally occurring things are "products of nature" which cannot be patented). Accordingly, the claims recite a judicial exception, and the analysis must therefore proceed to Step 2A Prong Two. For analysis in this Step this judicial exception is not integrated into a practical application because claims are drawn to simple products. Because the recited judicial exception is not integrated into practical application, the claims are still directed to judicial exception. Proceeding to Step 2B of eligibility analysis the claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because other limitations in the claims simply add additional compounds for improved delivery of microRNAs, such compounds do not affect structure or function of microRNA, which are not sufficient to amount to significantly more.
It is suggested to amend recitation “microRNA mimic” in claim 1 to “microRNA comprising backbone modification” to overcome the rejection in claims 1-7, 10-11, 13-14. It is suggested to exclude DNA encoding microRNA mimic from claim 8 to overcome the rejection.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-5, 8 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Shen et al (US 2009/0281167, November 2009, cited from IDS).
Concerning claims 1-3 Shen disclose microRNAs comprising miR-18a of SEQ ID NO: 113 or 114 and miR-199a of SEQ ID NO: 64 or 65, which can be used in combination for administration to a subject for stimulation of vascularization (see paragraphs [0013, 0011]). Such SEQ ID NO: 113 comprises instant SEQ ID NO: 1 and SEQ ID NO: 64 comprises instant SEQ ID NO: 14 (see sequence listing). Shen disclose that such microRNAs can comprise modifications such as phosphorothioate bonds (see paragraph [0079]), meaning that non-bonding oxygen atom in a phosphate group is substituted with sulphur.
Concerning claim 4 Shen disclose pharmaceutical compositions comprising the microRNAs and pharmaceutically acceptable excipients (see paragraphs [0126-0131]).
Concerning claim 5 Shen disclose pharmaceutical compositions comprising lipids for microRNA delivery (see paragraph [0129]).
Concerning claim 8 Shen disclose viral vectors comprising the microRNAs (see paragraph [0011]).
Claim(s) 1-7 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Mor et al (WO 2009/099465, August 2009, cited from IDS).
Concerning claims 1-3 Mor disclose hsa-miR-199a-3p of SEQ ID NO: 3 (see lines 5-6 on page 22), identical to instant SEQ ID NO: 14. Such microRNA can be modified with phosphorothioate linkage (see lines 20-21 on page 25), meaning that non-bonding oxygen atom in a phosphate group is substituted with sulphur.
Concerning claims 4-6 Mor disclose pharmaceutical compositions of the microRNA comprising cationic lipids for delivery of microRNAs (see lines 12-17 on page 33).
Concerning claim 7 Mor disclose pharmaceutical compositions comprising polymers (see lines 4-18 on page 38).
Concerning claims 8-9 Mor disclose expression vectors comprising microRNA of the invention (see lines 1-10 on page 26), such vector can be adeno-associated (see lines 1-5 on page 27).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 10-14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Shen, above, and in further view of Mor, above.
Teachings of Shen are discussed above.
Shen do not explicitly teach a stretch of RNA comprising miR-18a and miR-199a, or pharmaceutical compositions comprising cationic lipids.
Teachings of Mor are discussed above.
It would have been obvious to one of the ordinary skill in the art at the time of the invention to combine both miR-18a and miR-199a in one vector based on teachings of Shen and add cationic lipids to such composition based on teachings of Mor. One of the ordinary skill in the art would be motivated to do so because Shen teach administration of the both microRNAs for the same purpose to the subject and delivery of microRNA in a vector, motivating one of the art to combine both microRNAs in one vector, arriving at instant invention, a stretch of RNA combining both miR-18a and miR-199a in RNA vector. Further, Shen suggest delivery of microRNA using lipids and Mor teach cationic lipids for microRNA delivery, motivating one of the art to use cationic lipids for microRNAs delivery, arriving at instant invention. Limitations of claim 11 describe ways of obtaining RNA stretch of claim 10, such limitations do not change the structure of such stretch (see 112(d) rejection above).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,337,002. Although the claims at issue are not identical, they are not patentably distinct from each other because claims from ‘002 recite the same microRNA mimics of SEQ ID NOs: 14 and 29 as in instant claims.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 11,236,332. Although the claims at issue are not identical, they are not patentably distinct from each other because claims from ‘332 recite the same microRNA mimics of SEQ ID NOs: 1, 14 and 29 as in instant claims.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,391,943. Although the claims at issue are not identical, they are not patentably distinct from each other because claims from ‘943 recite the same microRNA mimics of SEQ ID NOs: 10, 33 and 35 as in instant claims.
Conclusion
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/EKATERINA POLIAKOVA-GEORGANTAS/ Primary Examiner, Art Unit 1637
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