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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/24/2026 has been entered.
Amended claims 2-3, 6, 8 and 12-23 are pending in the present application.
Applicant elected previously with traverse of Group I, which is drawn to a promoter for modulation expression of a target gene from a vector and a vector comprising the same promoter.
Claims 12-20 and claim 23 were withdrawn from further consideration because they are directed to a non-elected invention.
Accordingly, amended claims 2-3, 6, 8 and 21-22 are examined on the merits herein.
Response to Amendment
The rejection under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for Scope of Enablement was withdrawn in light of currently amended claims 2-3 and 6, particularly with the new limitation “The promoter of claim 8”.
Claim Rejections - 35 USC § 112 (Lack of Written Description)
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.
Amended claims 2-3 and 6 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. This is a new ground of rejection.
MPEP 2163 - 35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the “specification shall contain a written description of the invention ....” This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc). Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111 (Fed. Cir. 1991), clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” Vas-Cath Inc. v. Mahurkar, 19USPQ2d at 1117. The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed” Vas-Cath Inc. v. Mahurkar, 19USPQ2d at 1116.
The instant claims encompass a promoter comprising the nucleotide sequence of SEQ ID NO: 4, wherein the promoter increases expression of any target gene in vimentin-expressing astrocytes or Muller cells, while decreasing expression of the target gene in cells that do not express vimentin (claim 2); wherein the promoter increases expression of any target gene in vimentin-expressing cells, relative to expression of the target gene when using a vimentin promoter without an enhancer portion (claim 3); and wherein the promoter increases expression of any target gene in cells that express vimentin and decreases expression of the target gene in cells that do not express vimentin (claim 6).
Apart from disclosing the hVimentin Mini Promoter of SEQ ID NO: 4 comprised of the 42-bp human vimentin enhancer sequence of SEQ ID NO: 1, the 24-bp linker sequence of SEQ ID NO: 3, and the 363-bp human vimentin “core” promoter (hVim Core promoter) sequence of SEQ ID NO: 2 oriented in the 5’ to 3’ direction in Plasmid VZ-60 construct, and the hVimentin Mini Promoter is operably linked to a target gene in the same plasmid construct; wherein upon transient transfection the promoter construct containing the hVimentin Mini Promoter increases expression of the target gene relative the promoter construct containing only hVim Core promoter in vimentin-expressing primary astrocytes, while it decreases expression of the same target gene relative the promoter construct containing only hVim Core promoter in vimentin-negative MCF-7 cells (see at least Abstract; paragraphs [0006]-[0009]; Examples 1-2, 4; Figs. 1 and 3B; and original claim 1); the instant disclosure fails to provide sufficient/complete written description for a promoter comprising the nucleotide sequence of SEQ ID NO: 4 that increases expression of any target gene in vimentin-expressing cells, not necessarily limited to a target gene that is operably linked to the promoter in the same vector construct, as encompassed broadly by the instant claims? For example, which particular additional essential structural elements and/or critical structural components does the promoter comprising the nucleotide sequence of SEQ ID NO: 4 possess such that it increases expression of any target gene other than a target gene that is operably linked to the promoter in the same vector construct in vimentin-expressing cells?
Since the prior art before the effective filing date of the present application (12/13/2021) did not provide sufficient description and/or guidance regarding the above issue as evidenced at least by the teachings of Pieper et al (Eur. J. Biochem. 210:509-519, 1992), (Xie et al, Molecular and Cellular Biology 12:1266-1275, 1992), (Alam et al, Gene 282:103-111, 2002) and Korecki et al (Gene Therapy 28:351-372, 2021); it is incumbent upon the present specification to do so. The present application also fails to provide a representative number of species for a broad genus of a promoter comprising the nucleotide sequence of SEQ ID NO: 4, wherein the promoter increases expression of any target gene in vimentin-expressing cells (e.g., astrocytes or Muller cells) as claimed broadly.
The claimed invention as a whole is not adequately described if the claims require essential or critical elements which are not adequately described in the specification and which are not conventional in the art as of Applicants’ filing date. Possession may be shown by actual reduction to practice, clear depiction of the invention in a detailed drawing, or by describing the invention with sufficient relevant identifying characteristics such that a person skilled in the art would recognize that the inventor had possession of the claimed invention. Pfaff v. Wells Electronics, Inc., 48 USPQ2d 1641, 1646 (1998). The skilled artisan cannot envision the complete detailed structure of a representative number of species for a broad genus of a promoter comprising the nucleotide sequence of SEQ ID NO: 4, wherein the promoter increases expression of any target gene in vimentin-expressing cells (e.g., astrocytes or Muller cells) as claimed broadly, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method. Adequate written description requires more than a mere statement that it is part of the invention and reference to a method of isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 (Fed. Cir. 1991). One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481, 1483.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
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.
Amended claims 2-3 and 6 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. This is a new ground of rejection.
In amended claims 2-3 and 6, it is unclear what is encompassed by the limitations “wherein the promoter increases expression of a target gene in vimentin-expressing astrocytes or Muller cells”, “wherein the promoter increases expression of a target gene in vimentin-expressing cells”, and “wherein the promoter increases expression of a target gene in cells that express vimentin”, respectively. This is because it is not clear whether a target gene is an endogenous gene in vimentin-expressing cells, and/or a gene of a vector construct in which the promoter is operably linked to the gene. Clarification is requested because the metes and bounds of the claims are not clearly determined.
Examiner’s Comment
The prior art did not teach or fairly suggest a promoter comprising the nucleic acid sequence of SEQ ID NO: 4, and a vector comprising the same promoter.
Conclusions
Claims 8 and 21-22 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Quang Nguyen, Ph.D., whose telephone number is (571) 272-0776.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s SPE, James Douglas (Doug) Schultz, Ph.D., may be reached at (571) 272-0763.
To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Group Art Unit 1631; Central Fax No. (571) 273-8300.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
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/QUANG NGUYEN/Primary Examiner, Art Unit 1631