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 .
Claims 1-5, and 7-19 are pending and under examination in the instant application.
Priority
The present application filed on January 17, 2024, is a 35 U.S.C. 371 national stage filing of PCT/IB2023/050388, filed January 17, 2023. Also, acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP22152305.3, filed on 01/19/2022. Thus, the earliest possible effective filing date is 01/19/2022.
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 1-5 and 7-19 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.
From M.P.E.P. § 2163, the analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated possession of the claimed invention from the standpoint of one of skill in the art at the time the application was filed. For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession.
For claims drawn to a genus, possession may be shown (for example) through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A “representative number of species” means that the species which are adequately described are representative of the entire genus, and is an inverse function of the skill and knowledge in the art. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly. If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112, first paragraph.
Claim 1 is drawn to a nucleic acid sequence of at least 700 base pairs and having at least 80% identity to the nucleic acid sequence of SEQ ID NO: 1, wherein said isolated nucleic acid molecule leads to the specific expression in layer 2/3 of mouse cortex of an exogenous gene in a particular population of CUX 1-positive cells when a nucleic acid sequence coding for said exogenous gene is operatively linked to an isolated nucleic acid molecule.
Claim 1 recites a structure: a nucleic acid sequence of at least 700 bp having at least 80% identity to said sequence of SEQ ID NO: 1. Claim 1 also recites a function: wherein said isolated nucleic acid molecule leads to the specific expression in layer 2/3 of mouse cortex of an exogenous gene in a particular population of CUX 1-positive cells when a nucleic acid sequence coding for said gene is operatively linked to said isolated nucleic acid molecule. Thus, the claim is drawn to a very large genus of nucleic acid molecules comprising the claimed function.
Neither the specification nor the prior art establish a structure-function relationship wherein a nucleic acid, of at least 700 base pairs having 80% identity to SEQ ID NO: 1, would be capable of functioning as claimed with any degree of predictability.
The instant specification appears to only have one nucleic acid capable of providing for the claimed function of gene expression in layer 2/3 of mouse cortex in a particular population of CUX 1-positive cells: full-length SEQ ID NO:1 (Examples). SEQ ID NO: 1 is 864 base pairs. The specification does not disclose any other embodiments which would be encompassed within the pending claim. The specification does not identify what changes, mutations, fragments, etc. could be made to SEQ ID NO: 1, and that would be encompassed by the structural limitations of claim 1, and would predictably result in the claimed function of gene expression in layer 2/3 of mouse cortex in a particular population of CUX 1-positive cells. As such, the instant specification does not provide a sufficient representative sampling of structures that are as little as 80% identical and that have as few as 700 base pairs out of a possible 864 nucleic acids present in SEQ ID NO: 1 that are capable of providing for said function as claimed.
The prior art is unpredictable. It is noted that SEQ ID NO: 1 appears to be free of the prior art. In fact, there does not appear to be any structures in the prior art that are close to SEQ ID NO: 1, let alone any that have the recited function. Thus, the prior art cannot be relied upon for making up for the deficit of the instant specification with regard to a sufficient representative number of species that are as little as 80% identical and that have as few as 700 out of a possible 864 nucleic acids present in SEQ ID NO: 1 that provide for said function as claimed.
Finally, it is understood that engineering promoters resulting in functional expression is unpredictable. For example, Ho et al. discloses known promoters can be subjected to deletion analysis, insertion or deletion of known transcription factor binding motifs and mutated using artificial evolution to generate mutations (page 1575-1576). However, each of these methods are tested for function. In generating libraries of large numbers of mutants via artificial evolution, Ho et al. states, “There is a need for high-throughput methods to efficiently screen the large libraries generated” Page 1576, first column. See, Ho et al. (Ho et al., “Identifying and Engineering Promoters for High Level and Sustainable Therapeutic Recombinant Protein Production in Cultured Cells”. Biotechnology Letter, 2014. 36:1569-1579).
Accordingly, neither the specification nor the prior art establish a known structure-function relationship wherein the genus of structures that are as little as 80% identical and that have as few as 700 out of a possible 864 nucleic acids present in SEQ ID NO: 1 are capable of providing for the function as claimed with any predictability. The prior art highlights the need to individually test mutations for function. In this case, the skilled artisan would not have reasonable concluded at the time of the invention that application was in possession of the invention as claimed. Claims 2-5 and 7-19 are included in the rejection because they depend from claim 1.
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.
Claims 2, 10, 12, and 14-19 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Regarding claim 2, it recites “e.g. the minimal promoter of SEQ ID NO: 2”. The recitation “e.g.” is an exemplary language that leads to confusion over the intended scope of the claim and renders the claim indefinite. It is unclear if the minimal promoter of SEQ ID NO: 2 is an exemplary language or if the nucleic acid sequence of the minimal promoter is limited to SEQ ID NO: 2, specifically and it is part of the claimed invention. So this creates ambiguity and renders the claim indefinite. Therefore, the metes and bounds of the method recited in this claim cannot be determined. See MPEP 2173.05(d). Therefore, in the interest of compact prosecution, claim 2 is interpreted as not being limited to the particular embodiments following “e.g.”. Claims 12, 14, and 19, which depend from claim 2 are similarly rejected.
Regarding claims 10, and 14-18 recite “wherein the product of the exogenous gene is a light-sensitive molecule, for instance halorhodopsin or channelrhodopsin”. The recitation “for instance” is an exemplary language that leads to confusion over the intended scope of the claim and renders the claim indefinite. It is unclear if halorhodopsin or channelrhodopsin is an exemplary language or if the product of the exogenous gene is limited to halorhodopsin or channelrhodopsin and it is part of the claimed invention. So this creates ambiguity and renders the claim indefinite. Therefore, the metes and bounds of the method recited in this claim cannot be determined. See MPEP 2173.05(d). Therefore, in the interest of compact prosecution, claims 10 and 14-18 are interpreted as not being limited to the particular embodiments following “for instance”.
Allowable Subject Matter
Claims 1-5, and 7-19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C.
112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 1-5, and 7-19 are considered free of prior art for the following reasons:
The closest prior art of record Keller et al. (WO2021099860A1, filed on 10/23/2020, and published on 05/27/2021) teaches an isolated nucleic acid molecule comprising, or consisting of, the nucleic acid sequence of SEQ ID NO:1 or of a nucleic acid sequence of at least 1400 bp having at least 80% identity to said sequence of SEQ ID NO:1, wherein said isolated nucleic acid molecule leads to the specific expression of an exogenous gene in agmat-positive cells in layer 2/3 of mouse cortex when a nucleic acid sequence coding for said exogenous gene is operatively linked to said isolated nucleic acid molecule (Abstract and claim 1). However, Keller et al. fails to teach that the nucleic acid sequence of the isolated nucleic acid is identical to instant SEQ ID NO: 1 or at least 700 bp having at least 80% identity to instant sequence of SEQ ID NO: 1. Also, Keller et al. fails to teach that when a nucleic acid sequence coding for an exogenous gene is operatively linked to said isolated nucleic acid molecule, the isolated nucleic acid molecule leads to the specific expression of the exogenous gene in a particular population of CUX 1-positive cells that expresses FLT1, CSF3R and CLDN5 in layer 2/3 of mouse cortex.
Overall, the prior art fails to sufficiently teach or render obvious an isolated nucleic acid molecule comprising the nucleic acid sequence of SEQ ID NO:1 or of a nucleic acid sequence of at least 1400 bp having at least 80% identity to said sequence of SEQ ID NO:1 as claimed.
The instant claimed isolated nucleic acid molecule that leads to the specific expression of an exogenous gene in a particular population of CUX 1-positive cells that expresses FLT1, CSF3R and CLDN5 in layer 2/3 of mouse cortex when a nucleic acid sequence coding for the exogenous gene is operatively linked to said isolated nucleic acid molecule is considered allowable in view of the prior art of record, such that a person having ordinary skills in the art, at the time invention was made, would not have envisaged the isolated nucleic acid currently claimed, nor does the prior art render obvious the method of expressing the exogeneous gene currently claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANAN ISAM ABUZEINEH whose telephone number is (571)272-9596. The examiner can normally be reached Mon- Fri 8:30-5:00.
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Hanan Isam Abuzeineh
/H.I.A./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
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