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 .
Applicant’s amendment filed on 04/03/2026 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Claims 12-20 and 23 were withdrawn from further consideration because they are directed to a non-elected invention.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.
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 modified rejection necessitated by Applicant’s amendment.
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 are drawn to a promoter, comprising the nucleotide sequence of SEQ ID NO: 4, wherein the promoter is operably linked to a target gene in a vector, and wherein the promoter increases expression of a target gene in vimentin-expressing astrocytes or Muller cells, not necessarily limited to the target gene in a vector, and decreases expression of the target gene in cells that do not express vimentin (claim 2); the same promoter, wherein the promoter when operably linked to the target gene in the vector, increases expression of a target gene in vimentin-expressing cells, not necessarily limited to the target gene in a vector, relative to expression of the target gene when using a vimentin promoter without an enhancer portion (claim 3); and the same promoter, wherein the promoter when operably linked to the target gene in the vector, increases expression of a target gene in cells that express vimentin, not necessarily limited to the target gene in a vector, 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).
Response to Arguments
Applicant’s arguments related to the above modified 112(a) rejection in the Amendment filed on 04/03/2026 (pages 5-6) have been fully considered, but they are respectfully not found persuasive for the reasons discussed below.
Applicant argued basically amended claims 2, 3 and 6 have been amended to clarify that the recited promoter comprising the nucleotide sequence of SEQ ID NO: 4 is operably linked to a target gene in a vector, and that the recited increases or decreases in gene expression occurs with respect to that operably linked target gene; and the application-as-filed meets the Written Description requirement of the currently amended claims.
It is noted that currently amended claims are not necessarily limited to a promoter that increases or decreases expression of a target gene that is operably linked to the promoter on a vector. Please refer to the above modified rejection for details, particularly Examiner’s interpretation of currently amended claims 2, 3, and 6.
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 modified rejection necessitated by Applicant’s amendment.
In amended claims 2-3 and 6, it is still 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 in the above limitations refers to another target gene in vimentin-expressing cells (e.g., an endogenous target gene of vimentin-expressing cells), or a target gene in a vector that the promoter is operably linked to. Clarification is requested because the metes and bounds of the claims are not clearly determined. Should Applicant intend to refer to a target gene in a vector, then the term “a target gene” in the above limitations should be replaced by “the target gene”.
In currently amended independent claim 2, it is unclear whether the claim requires a target gene in a vector apart from a promoter comprising the nucleotide sequence of SEQ ID NO: 4. Basically, it is unclear whether Applicant intends to claim a promoter or a vector comprising the same promoter. Once again, clarification is requested because the metes and bounds of the claim are not clearly determined.
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.
Amended claims 3 and 6 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. Amended claims 3 and 6 recite the limitations “increases expression of a target gene in vimentin-expressing cells” and “increases expression of a target gene in cells that express vimentin”, respectively. However, both claims 3 and 6 are dependent on amended independent claim 2 which already recites the limitation “increases expression of a target gene in vimentin-expressing astrocytes or Muller cells”, which is narrower limitation than those recited in dependent claims 3 and 6. 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. This is a new ground of rejection necessitated by Applicant’s amendment.
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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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