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 5, 14, 15, 17-19 are pending and under examination.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/15/2026 has been entered.
WITHDRAWN REJECTION
Claim Rejections - 35 USC § 102
Claims 5, 14-15 and 17-19 were rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Number 9,840,718 (hereinafter ‘718 Patent; published Jun 2016; See PTO-892 of 09/19/2024) as evidenced by Cary (See PTO-892 of 9/19/2024).
The rejection is withdrawn following claim amendment to cancel mammalian cells.
Claim Objections
Claim 19 was objected to because of the following informalities: "trans-kingdom" was misspelled.
The objection is withdrawn following correction of the term.
NEW REJECTIONS
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 15, 18-19 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 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.
Claim 15 recites a method of gene therapy using an expression vector comprising SEQ ID NO: 1, the method comprising inserting the vector into yeast cells and E. coli.
It is noted that instant specification at [0089] indicated the following: “By “gene therapy” is meant herein to denote inserting, inside specific host cells, expression vectors comprising specific gene sequences of interest in order to cure diseases, preferably genetic diseases.”
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 without undue or unreasonable experimentation. See Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916). The key word is 'undue,' not experimentation.' " (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
Claim 15 recites “gene therapy”, the dependent claims under rejection do not further limit the disease or disorder. The breath of the claims thus covers every disease and every disorder possible. Thus scope of the claims thus covers diseases or disorders characterized by tissue loss or damage (i.e. wounds to the epidermis, degenerated cartilage, organs which have suffered physical damage), diseases characterized by insufficient tissue (i.e. diabetes mellitus), diseases or disorders characterized by hyperproliferation of tissue (i.e. tumors), diseases or disorders characterized by aberrant immune response (i.e. auto-immune disorders), infections (bacterial, fungal, viral), genetic disorders, psychological disorders and diseases (i.e. schizophrenia, bi-polar disorder, depression), and more. Any and all diseases and disorders are covered by the claims. The claims do not limit the scope of the disease and/or disorders as having any common symptom, etiology, or mechanism (known or unknown). The breadth of the claims is thus extremely broad.
The nature of the invention is gene therapy for transkingdom gene expression using promoter of T. ni transposase. While the basis of gene therapy was well-known at the time the invention was made, due to the complex interactions which occur within cells, and the body itself and lack of understanding of the exact mechanisms of action of specific cells, it was still considered a highly complex field.
The artisan of ordinary skill would be one having an advanced degree in cell biology and/or significant experience in studying gene therapy.
At the time the invention was made gene therapy was known to be effective in treatment of certain genetic diseases for example, sickle cell disease, Wiskott–Aldrich syndrome (WAS) beta-thalassemia, X-linked adrenoleukodystrophy and metachromatic leukodystrophy (See, e.g. Mukherjee et al. Gene, 2013). However, gene therapy was not known to be suitable for cure of genetic diseases (See Goswami, 2019). It was known to a person of ordinary skill before the filing of instant application, that design of extensive experimentation and research was needed for development of targeted vectors to increase transduction efficiency and to overcome the immune response, and consideration of the concept of ‘genotoxicity’ testing as well as expansion of placebo-controlled clinical trials; all of which are fundamental to development of a therapeutic for gene therapy. (See e.g., Tremblay. Feb 2021 see PTO-892 of 09/19/2024). It would still be unknown to an ordinary person of skill in the art whether these therapeutics amount to treatment or cure of genetic diseases.
There was no evidence at the time the invention was made that claimed promoter or indeed any promoter would have any effect on all genetic disorders. There was no known link between, at least these types of diseases and disorders, and promoters.
The examples provided in the specification show that the claimed promoter sequence can lead to protein expression in various cells. The examples are found to support that the claimed promoter sequence can promote expression of at least some proteins in the demonstrated organisms. There is no demonstration of gene therapy of any disease using the claimed promoter sequence. While multicellular organisms including humans are known to suffer from variety of disease states, including genetic diseases, the specification defines “gene therapy” as methods intended to cure such diseases through insertion of expression vectors into host cells, when the specification only shows basic luciferase reporter activity data in a handful of organisms. It is further noted that gene therapy. It is also demonstrated that the specification defines gene therapy as requiring “curing” a genetic disease. However, the specification does not demonstrate or provide examples of achieving such therapeutic outcome.
The scope of the claims is beyond what was known/expected based on the prior art, and taught in the instant specification.
Claims 18-19 are rejected for their dependence on rejected claim.
Claims 5, 14, 15, and 17-19 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.
Claims 17-18 require an expression vector to be selected from a plasmid, cosmid, phage, bacteriophage, Yeast Artificial Chromosome (YAC), Bacterial Artificial Chromosome (BAC) or viral vector. It is noted that the specification only demonstrated expression of proteins such as luciferase from a pPB-XpreS plasmid. The specification did not describe representative species or demonstrate possession of cosmid, phage, bacteriophage, Yeast Artificial Chromosome (YAC), Bacterial Artificial Chromosome (BAC) or viral vector, which requires a materially different structural features, host requirements, and functional properties. It is also generally known that cosmids, BAC and YAC are important tools for storing large inserts. (See Bajpai Abstract, See PTO-892). Similarly, viral vectors are used for gene delivery and expression in animal models and mammalian cells, not microorganisms like yeast and bacteria. For example, See Howarth Abstract (See PTO-892).
Accordingly, a disclosure of plasmid-based embodiment is not sufficient to reasonably convey to a person of ordinary skill in the art that the inventor was in possession of the full scope of the claimed genus of expression vectors at the time of filing.
Regarding claim 5: The claims recite methods involving fungal cells or broadly encompasses fungal systems. However, the specification is limited to disclosure of transformation and expression in yeast cells, including the BMA64 strain of S. cerevisiae, using lithium chloride-based transformation method. While yeast are a subset of fungi, the specification does not provide representative species, structural features or technical guidance demonstrating possession of the full scope of fungal organisms encompassed by the claim. In particular, the disclosure is confined to a single yeast system and does not describe or reasonably suggest applicability beyond S. cerevisiae such as to other fungal organisms such as filamentous or non-yeast fungi, which differ in cellular structure.
Accordingly, the specification demonstrates possession at most of S. cerevisiae-based embodiments. The disclosure does not reasonably convey to a person of ordinary skill in the art that the inventor was in possession of the full scope of the claimed invention at the time of filing.
Conclusion
No claim is allowed.
Claims 5, 14, 15 and 17-19 are free of art.
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/JAGAMYA NMN VIJAYARAGHAVAN/Examiner, Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633
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