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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/23/26 has been entered.
Allowable Subject Matter
Claims 13 and 16 are allowed.
Claim Rejections - 35 USC § 112
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 15, 18, 21, and 27 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 13 is directed to a polynucleotide consisting of SEQ ID NO: 1. Claim 15 depends from claim 13 and requires for 374 bp to 3151 bp of SEQ ID NO: 1 to be replaced with SEQ ID NO: 4, which fails to narrow the scope of claim 13. Making a replacement of nucleotides of SEQ ID NO: 1 with a different sequence broadens the scope of claim 13 that is limited to a polynucleotide consisting of SEQ ID NO: 1.
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.
Claims 18, 21, and 27 are rejected because they depend from claim 15.
From a review of applicant’s statements regarding the sequences (1/23/26), it appears that nucleotides 374-3151 of SEQ ID NO: 1 are identical to instant SEQ ID NO: 4. If this is correct, nucleotides 374-3151 of SEQ ID NO: 1 are not being replaced with SEQ ID NO: 4, as recited in instant claim 15 because SEQ ID NO: 1 already comprises the same sequence.
Claims 19, 21, 25, and 27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of expressing TIF1γ, does not reasonably provide enablement for a method of treating any of the instantly recited fibrotic diseases via delivery of a polynucleotide consisting of instant SEQ ID NO: 1. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Factors to be considered in a determination of lack of enablement include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)
The instant claims are directed to a method of treatment of any hepatic fibrosis, pulmonary fibrosis, idiopathic pulmonary fibrosis, progressive massive fibrosis, renal fibrosis, or nephrogenic systemic fibrosis via delivery of a polynucleotide consisting of instant SEQ ID NO: 1.
The specification does not draw an adequate nexus between delivery of a polynucleotide consisting of instant SEQ ID NO: 1 and the predictable outcome of treating any hepatic fibrosis, pulmonary fibrosis, idiopathic pulmonary fibrosis, progressive massive fibrosis, renal fibrosis, or nephrogenic systemic fibrosis.
The specification discloses that delivery of a specific recombinant vector comprising a polynucleotide consisting of SEQ ID NO: 1 (codon optimized TIF1γ) resulted in a fibrosis inhibitory effect in hepatic fibrotic cells; which is not commensurate in scope with treating any hepatic fibrosis, pulmonary fibrosis, idiopathic pulmonary fibrosis, progressive massive fibrosis, renal fibrosis, or nephrogenic systemic fibrosis in vivo.
The specification discloses that delivery of a vector comprising a polynucleotide consisting of SEQ ID NO: 1 reduced SMA and Col1A, but does not demonstrate that any reduction of SMA or Col1A would necessarily treat any hepatic fibrosis, pulmonary fibrosis, idiopathic pulmonary fibrosis, progressive massive fibrosis, renal fibrosis, or nephrogenic systemic fibrosis.
The scope of the claims in view of the specification as filed together do not reconcile the unpredictability in the art to enable one of skill in the art to make and/or use the claimed invention, namely a broad method of treating any hepatic fibrosis, pulmonary fibrosis, idiopathic pulmonary fibrosis, progressive massive fibrosis, renal fibrosis, or nephrogenic systemic fibrosis encompassing in vivo effects.
MPEP 2164.01
Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.
Also, MPEP 2164.01(a)
A conclusion of lack of enablement means that, based on the evidence regarding each of
the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed
invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27
USPQ2d 1510, 1513 (Fed. Cir. 1993).
Given the teachings of the specification as discussed above, one skilled in the art could not predict a priori whether introduction of a polynucleotide consisting of instant SEQ ID NO: 1 in vivo by the broadly disclosed methodologies of the instantly claimed invention, would result in successful treatment of any hepatic fibrosis, pulmonary fibrosis, idiopathic pulmonary fibrosis, progressive massive fibrosis, renal fibrosis, or nephrogenic systemic fibrosis. To practice the claimed invention, one of skill in the art would have to de novo determine; the stability of the polynucleotide in vivo, delivery to the whole organism, specificity to the target tissue in vivo, dosage and toxicity in vivo, and entry of the polynucleotide into the cell in vivo and the effective action therein. Without further guidance, one of skill in the art would have to practice a substantial amount of trial and error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation (see MPEP 2164.01(a)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amy R Hudson whose telephone number is (571)272-0755. The examiner can normally be reached M-F 8:00am-6:00pm.
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/AMY ROSE HUDSON/Primary Examiner, Art Unit 1636