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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 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 1, 6-8, 12-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims are broadly drawn to methods of treatment of a patient diagnosed with pulmonary arterial hypertension by administering an inhibitor of sphingosine kinase 2, such inhibitor can be small molecule or antibody.
Instant claims encompass treatment of a patient with a wide variety of sphingosine kinase 2 inhibitors of varied chemical structure such as small molecules and antibodies.
Instant specification describes a wide genus of sphingosine kinase 2 inhibitors as including interfering RNAs, small molecules and antibodies (see paragraph [0012]). Instant specification provides some examples of inhibition using such interfering RNAs (see paragraph [0078], Example 1) and one example of specific small molecule inhibitor (see paragraph [0079]). There are no examples of sphingosine kinase 2 inhibition using antibodies.
It is well known in the art that mechanism of action of interfering RNAs, small molecules and antibodies is very different: interfering RNAs decrease protein expression, while small molecule inhibitors and antibodies bind target protein to prevent its activity. Further, such inhibitors are very structurally diverse: interfering RNAs are nucleic acids, small molecule inhibitors are organic compounds of a small size, while antibodies are very large protein structures.
Specification does not describe structure for representative species of Applicant's broadly claimed genus. Thus, their function of inhibiting sphingosine kinase 2 is either unknown or unpredictable.
The genus of sphingosine kinase 2 inhibitors encompasses a large number of unknown structures and one of skilled in the art cannot reliably predict which member of the genus would successfully inhibit sphingosine kinase 2, and which will not.
There is no description of the necessary and sufficient elements of the species encompassed by the breadth of the claims.
The only species described in specification are interfering RNAs and one specific small molecule inhibitor. Applicant fails to describe representative members of Applicant's broadly claimed genus.
One of the skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the disclosed species. Since the disclosure fails to describe the common attributes that identify members of the genus, and because the genus is highly variant, interfering RNAs and one specific small molecule inhibitor are not sufficient to describe the claimed genus. Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, it is not clear that Applicant was in possession of the claimed genus at the time this application was filed.
Claims 4, 6, 13-14 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 4 recites the limitation "the interfering RNA" in the first line. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination it will be considered that claim 4 depends on claim 2, but appropriate correction is required.
Claims 6, 13-14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps. See MPEP § 2172.01. The omitted steps are: actual active steps of a compound administration which would lead to effects described in claims 6, 13-14.
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.
Claim(s) 1, 6-8, 12-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bittman et al (WO 2014/118556, August 2014).
Concerning claims 1, 6-8, 12-17 Bittman disclose methods of reducing vascular remodeling in a patient diagnosed with pulmonary arterial hypertension by administering inhibitors of sphingosine kinase 2 (see Abstract, lines 10-15 on page 21). Such inhibitors can be small molecules decreasing sphingosine kinase 2 activity presented on page 12 (see lines 6-7 on page 22). Bittman is silent concerning decreasing histone 3 acetylation and effects of claims 13-14, 16-17, but such effects are expected to happen in the absence of evidence to the contrary upon practicing the methods.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 6-10, 12-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bittman, above, as applied to claims 1, 6-8, 12-17, and in further view of Hait et al (Science, 2009, vol.235, pages 1254-1257 and Supplementary Materials, cited from IDS).
Teachings of Bittman are discussed above.
Bittman do not teach sphingosine kinase 2 inhibitors being interfering RNAs such as of instant SEQ ID NOs: 1-4 targeting nucleic acid sequence common to each of four splice variants.
Hait teach interfering RNAs targeting sphingosine kinase 2 (see first column on page 1255). Such interfering RNA can be of sequence shown in lines 8-9 on second page of Supplementary Materials, identical to instant SEQ ID NOs: 1-4.
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to treat pulmonary arterial hypertension by administering interfering RNAs taught by Hait based on teachings of Bittman. One of the ordinary skill in the art would be motivated to do so, because Bittman teach treatment of pulmonary arterial hypertension by inhibitors of sphingosine kinase 2 and Hait provide such effective inhibitors.
Claim(s) 1, 5-8, 11-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bittman, above, as applied to claims 1, 6-8, 12-17, and in further view of Rabbani et al (US 2018/0369212, December 2018).
Teachings of Bittman are discussed above.
Bittman do not teach sphingosine kinase 2 inhibitor as compound of structure in instant claims 5 and 11.
Rabbani teach selective sphingosine kinase 2 inhibitor identical to the compound in instant claims 5 and 11, where R is Cl (see paragraph [0049]).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to treat pulmonary arterial hypertension by administering the compound taught by Rabbani based on teachings of Bittman. One of the ordinary skill in the art would be motivated to do so, because Bittman teach treatment of pulmonary arterial hypertension by inhibitors of sphingosine kinase 2 and Rabbani provides such selective inhibitor.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
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