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 .
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.
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 1-8 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.
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the application coupled with information known in the art without undue experimentation (United States v. Telectronics, Inc. 8 USPQD2d 1217 (Fed. Cir. 1988)). Whether undue experimentation is required is a conclusion reached by weighing several factors. These factors were outlined in Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and again in In re Wands, 8 USPQQ2d 1400 (Fed. Cir. 1988) and include the following:
State of the prior art and level of predictability in the art: In spite of considerable interest in neural crest derived cells, the art of record contains no description of methods of separating them from the peripheral blood. Achilleos et al (Cell Res., 2012) teaches that primary neural crest cells (NCC) are isolated with affinity techniques from primarily neural tissue (p. 290) or are prepared from induced pluripotent stem cells. Achilleos et al makes no mention of isolating NCC from peripheral blood by merely “separating” the cells, or centrifugation techniques as currently claimed. Thus, the art cited is silent with regard to the isolation of NCCs from peripheral blood and equally silent about what specific methods other than affinity for certain cell surface markers can be used for successful isolation.
This clearly evidences that isolating NCCs from peripheral blood was at an early stage of development at the time of filing and that the skilled artisan would not know how to isolate NCCS from peripheral blood without explicit guidance from the specification or significant empirical experimentation.
Amount of direction provided by the inventor and existence of working examples:
In the working examples, the specification teaches the induction of NCC/MSC aggregates in a very specific murine model of silicosis. The EGFP-positive cells presumed to be NCC/MSC were detectable by FACS. See Example 2. NCCs could then be isolated and cultured from the blood of the transgenic mice after several centrifugation steps and cell culture. See Example 3.
Although the specification suggests NCCs could isolated from any given organism without the induction of NCC aggregates by a silicosis model in a transgenic mouse, there is no evidence that the methods contemplated would actually produce the aggregates or isolated NCCs. Thus, in order to practice the invention as claimed, the skilled artisan would have to further develop the methods of isolating NCCs capable of functioning in the wide variety of species encompassed by the claims.
Nature of the invention and Breadth of the claims: The claims are directed to methods of isolating NCCs, the properties of which have been outlined above. The claims are not limited to any particular animal species, or any particular method step that would provide these specific cells (see claim 1). Thus, the claimed methods encompass a divergent genus of potential methods having different components or method steps. As the claims encompass a wide variety of species, it is incumbent upon the disclosure to set forth the manner and process of making a variety of species that is commensurate with the scope of protection sought.
Relative skill of those in the art and quantity of experimentation needed to make or use the invention: Although the level of skill in the art of cell isolation is high, the level of skill in the art or isolating HCCs from peripheral blood is low. One would not be able to practice the claimed methods in other species or mouse strains given no more than the teachings available at the time of filing without undue experimentation. The art of record does not provide a single working example of isolating NCCs from peripheral blood. Likewise, all of the teachings in the instant application are specifically directed to making NCCs from a specific mouse strain that had been induced with silicosis. Given the broad scope of the claims, the early developmental stage and the unpredictability of the art at the time of filing, making embodiments of the claimed invention beyond the specific example provided would clearly require undue experimentation. Therefore, the claims are properly rejected under 35 USC 112, first paragraph, as lacking enablement.
Given the above analysis of the factors which the courts have determined are critical in determining whether a claimed invention is enabled, it must be considered that undue and excessive experimentation would have to be conducted by the skilled artisan in order to practice the claimed invention.
Claims 1-8 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.
The claims are replete with grammatical errors and appear to be a literal translation of a foreign language. This renders interpretation of the claims confusing and clumsy.
Conclusion
No claim is allowed.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638