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 .
Election/Restrictions
Applicant’s election without traverse of Group IV in the reply filed on 06/12/2026 is acknowledged.
Claims 1-14, 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/12/2026.
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) 15-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xu et al (Nature Communications, 19 January 2021, 12: 447, pages 1-16, cited from IDS).
Concerning claims 15-19 Xu disclose method of treating a subject having propensity to develop an intraventricular hemorrhage by administering AAV2/5 vector expressing NKCC1 polynucleotide encoding NKCC1 polypeptide increasing NKCC1 expression level and reducing intracranial fluid imbalance (see pages 5-6, Figures 5 and 6). Such overexpression leads to reduced ventriculomegaly (see second column on page 6), accelerated potassium clearance, cerebrospinal compliance, reduced circulated cerebrospinal fluid in the brain and intracranial pressure (see page 6).
Concerning claim 20 the vector was administered by intracerebroventricular injection (see second column on page 4).
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) 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gregoriades et al (Am J Physiol, 2019, pages 1-73, cited from IDS) and in further view of Kahle et al (Lancet, 2016, vol.387, pages 788-799, cited from IDS), Drivas et al (US 2016/0185832, June 2016) and Frost et al (US 2019/0358346, November 2019).
Gregoriades teach that NKCC1 transporter has overall absorptive function for cerebrospinal fluid (CSF) in the brain (see Abstract).
Gregoriades do not teach treatment of intraventricular hemorrhage by administering adeno-associated virus (AAV) vector such as AAV2/5 administered by intracerebroventricular injection comprising a polynucleotide encoding NKCC1 polypeptide leading to effects of instant claims 17-19.
Kahle teach that intraventricular hemorrhage is a common cause of hydrocephalus caused by accumulation of CSF in the brain (see Table 1, Abstract, page 788).
Drivas teach gene delivery using AAV 2/5 vector (see paragraph [0081]).
Frost teach delivery of AAV vector to central nervous system by intracerebroventricular injection (see paragraph [0109]).
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 intraventricular hemorrhage by administering AAV 2/5 vector comprising a polynucleotide encoding NKCC1 polypeptide by intracerebroventricular injection based on teachings of Gregoriades, Kahle, Drivas and Frost. One of the ordinary skill in the art would be motivated to do so, because Gregoriades teach that NKCC1 polypeptide has absorptive function for CSF in the brain, therefore it can be used for CSF absorption when it is excessive in the case of intraventricular hemorrhage as taught by Kahle. Drivas teach a delivery vector for producing NKCC1 polypeptide and Frost teach a way of administration of such vector, which can be used for such treatment. The effects of instant claims 17-19 are expected to happen upon such treatment in the absence of evidence to the contrary.
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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