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.
Claims 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for systems comprising a mixer or pump, first and second pH electrodes and controller, first and second UV sensors and controller, and a column, does not reasonably provide enablement for CVI systems that comprise only a pH feedback controller and a MRT feedback controller. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
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 CVI systems the art of record contains no description of CVI methods or systems that are operative that comprise only a pH feedback controller and a MRT feedback controller. Parker et al (Bioech Bioengineer., 2017, of record) teach a system comprising a protein capture column, a mixer/pump, a low pH reactor and two static mixers in order to provide CVI and the required minumum residence time or RTD. Similarly, Martins et al (2020, of record) teach such a system comprises pumps, a packed bed column, a mixer and sampling port.
This statement clearly evidences that CVI systems comprising only a pH feedback controller and a MRT feedback controller were at an early stage of development at the time of filing and that the skilled artisan would not know how to make and use such a CVI system 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 example, the CVI system comprised mixers, a pump, pH electrodes and UV sensors connected to a controller that in turn controlled the pump and a column.
Thus, in order to make and use the invention as claimed, the skilled artisan would have to further develop the methods and devices of performing CVI such that the claimed system would be capable of functioning as a CVI system.
Nature of the invention and Breadth of the claims: The claims are directed to a system for CVI, the properties of which have been outlined above. The claims are not limited to any particular pH feedback controller or MRT controller and do not require a pump, a column, sensors, etc.. Thus, the claimed systems encompass a divergent genus of CVI systems. As the claims encompass a wide variety of such systems, it is incumbent upon the disclosure to set forth the manner and process of performing CVI 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 is high, the level of skill in the art of performing CVI with only a pH feedback controller and a MRT feedback controller is low. The art of record does not provide a single working example of such a system. 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 that are operative with only a pH feedback controller and a MRT feedback controller 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.
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 21 and 22 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.
Claims 21 and 22 recite the limitation "the target molecules" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Allowable Subject Matter
Claims 11-20 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638