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 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 1-23 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 recite treatments with STP707. Nowhere in specification STP707 is specifically defined. It is not clear if STP707 comprises specific siRNAs or any siRNA targeting TGFβ1 and COX2 and what other components it can comprise. Therefore the metes and bounds of claims are not clear.
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 on claim 11 and originally on claim 1. Claim 12 adds a limitation that concentration of TGFβ1 is determined using ELISA. The way of determining concentration of TGFβ1 does not materially affect the method of claim 1, which is a method of treatment 2019-nCoV infection by administering STP707. Therefore claim 12 does not further limit claim 11.
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 § 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.
Claim(s) 1-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Witkowski et al (Nature, published online 25 October 2021, vol.600, pages 295-301) and in further view of Tang et al (US 2021/0246448, August 2021, cited from IDS), Evans et al (US 2021/0324384, October 2021, cited from IDS) and Bjorksten et al (US 2005/0271641, December 2005).
Witkowski teach that increase in TGFβ activity upon infection with 2019-nCoV decreases activity of natural killer cells, therefore exacerbating such infection (see Abstract). TGFβ1-blocking antibody prevents such inhibitory effect (see first column on page 300).
Witkowski do not teach prevention or treatment of 2019-nCoV infection by administering STP707 to a human before or after exposure to the virus, intravenously or intratracheally, wherein subject exhibits elevated expression of TGFβ1, determined by ELISA.
Tang teach siRNA therapeutics for prevention and treatment of 2019-nCoV infection (see Abstract). Such siRNAs target and degrade specific mRNAs, preventing expression of those specific genes (see paragraph [0045]). Such siRNAs can be introduced intravenously (see paragraph [0110]) or intratracheally (see paragraph [0120]). The subject to treat can be human (see paragraph [0017]).
Evans teach STP707 compound consisting of 2 siRNAs targeting TGFβ1 and Cox2 genes protected by a polypeptide delivery nanoparticle consisting of the branched polypeptide HKP (Histidine Lysine Polymer) (see paragraph [0065]) for treatment of cancer (see Abstract). Such compound can be administered intravenously (see paragraph [0025]) to humans (see paragraph [0024]).
Bjorksten teach determination of TGFβ1 level using ELISA (see paragraph [0072]).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to administer STP707 compound to humans for treatment of 2019-nCoV infection, before or after such infection based on teachings of Witkowski, Tang, Evans and Bjorksten. One of the ordinary skill in the art would be motivated to do so based on teachings of Witkowski that increase in TGFβ1 level exacerbates 2019-nCoV infection, motivating one of the art to reduce level of TGFβ1 using STP707 compound taught by Evans, because Witkowski already suggest reducing level of TGFβ1 by antibody and Tang teach a different way to reduce level of a protein using siRNA in relation to treatment of 2019-nCoV. It would be a matter or ordinary optimization to identify specific times of the compound administration as in instant claims 3, 8 and 19.
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