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 .
Status of Claims
Claims 1-8, 10, 12, 15-16, 18-20, 22-23, and 25-26. Claims 9, 11, 13-14, 17, 21, and 24, are cancelled.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/06/2026 has been entered.
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 6 and 8 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.
Claim 6 requires:
“The variant of claim 1, wherein the capsid protein comprises an amino acid sequence that is at least 95% identical to the sequence set forth in SEQ ID NO: 2
This claimed composition encompasses polypeptides comprising ≥95% identity to SEQ ID NO: 2.
Applicant’s claims do not provide support for all amino acids comprising ≥95% identity to SEQ ID NO: 2. The specification as filed does not provide sufficient evidence that Applicants were in possession of the full scope of the claimed invention at the time of filing of the instant invention. As such, >95% identity to a 736 amino acid polypeptide encompasses
736
C
37
×
19
37
=
m
o
r
e
t
h
a
n
1
×
10
110
polypeptides, if only substitutions were considered. However, the claim wording encompasses deletions, insertion mutations as well. This amounts to enormous number of polynucleotides which do not have support in the specification. The specification also does not provide any guidance on how or where the amino acids need to be changed, to preserve function. The specification also did not provide sufficient guidance or predictive structure-function relationships to distinguish operative form in operative variants across full scope of the claims. It is clear that the vector of the invention was restricted to SEQ ID NO: 2. For example, see instant specification at [0043]-[0045].
Thus, Applicants were not in possession of the full scope of the claimed invention at the time of filing of the instant invention.
Similar rejection applied to claim 8 which encompasses twice number of polypeptides as position 178 is the wild card amino acid.
Claims 19-20 and 22-23 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 enablement requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is submitted that the specification, while being enabling for transduction of liver using the claimed AAV, does not reasonably provide enablement for treatment of any disease.
The Applicants have claimed a method of treating any and all liver diseases as encompassed by claim 19. However, the experimental data in the application did not teach treatment of any and all liver diseases using the claimed AAV3B construct. Applicant’s experimental data taught that the mice can be transduced with the claimed AAV3B vectors and their liver can be transduced. (Example 2). Therefore, at most Applicant’s data taught liver transduction using the claimed constructs. None of the experiments taught treatment of any and all liver diseases. The data supports transduction of a gene of interest in SERPINA1 locus.
It is generally recognized that liver diseases include, cancers, viral infections, inflammatory diseases as well as monogenic metabolic diseases. Diseases such as non-alcoholic fatty liver diseases alone represent a heterogenous spectrum of conditions ranging from simple steatosis to steatohepatitis, cirrhosis, fibrosis as well as cancer. (See Liu p. 8, 2nd para, PTO-892). Similarly autoimmune liver disease models further exhibit complex and distinct immunological mechanisms and clinical courses that vary significantly across subtypes and patient population, requiring specialized and disease-specific therapeutic approaches. (See Than abstract, PTO-892).
In view of this well-established heterogeneity in liver disease biology and treatment response, the specification fails to provide sufficient guidance, representative species or structure-function relationships that would allow a skilled artisan to practice the full scope of the claim. Therefore, the breadth of claim 19 is not commensurate with the scope of the disclosure and enablement requirement is not satisfied.
Claims 20, 22-23 are rejected for their dependency on claim 19.
Allowable Subject Matter
Claims 1-5, 7, 10, 12, 15-16, 18, 25-26 appear to be directed to allowable subject matter. The following is a statement of reasons for the indication of allowable subject matter: from the sequence search, the sequences recited in claim 1 appear novel and unobvious over prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAGAMYA VIJAYARAGHAVAN whose telephone number is (703)756-5934. The examiner can normally be reached 9:00a-5:00p.
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/JAGAMYA NMN VIJAYARAGHAVAN/ Examiner, Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633