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 Submission of a Response
Applicant’s submission of a response was received on 4/28/2026. Applicant’s amendments overcomes the applied obviousness rejections but due to the change in scope of the term “optimal stability state” as a specific point during the process where the valve positions are captured rather than just broadly describing where the process is operational, rejections under 35 USC 112 have been applied below.
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 1-2, 6-7, and 10-11 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 amended claims now recite “the measured mass flow control valve position and the measured pressure control valve position captured during the optimal stability state.” The recitation of “an optimal stability state” in prior claim versions was treated similarly to “an effective amount” where the term is broad and any state that functions for a field flow fractionator could be considered an optimal stability state. The claims now recite the valve positions are “captured during the optimal stability state” and Applicant’s arguments state that such an optimal state is different than the merely open and closed positions. As such, enablement analysis was conducted on whether one skilled in the art would know how to make and use the invention. There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to:
The breadth of the claims;
The nature of the invention;
The state of the prior art;
The level of one of ordinary skill;
The level of predictability in the art;
The amount of direction provided by the inventor;
The existence of working examples; and
The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In this case, the breadth of claims are directly tied to when the process is deemed at “am optimal stability state.” The nature of the invention is a field flow fractionator control means and field flow fractionators along with control systems are known in the art. There is a fairly high predictability in the art as the valves open and close in order to control the operation of system. In regards to what is considered “an optimal stability state,” Applicant’s specification merely recite the term but fail to provide any basis as to what an optimal stability state is. Further, the term is not commonly known and used in the art as no recitations were found in the patent database. There were no experimental data or evidence provided to allow one skilled in the art to know what an optimal stability state is. Therefore, the amount of experimentation needed to determine what is the optimal steady state and then capture the valve positions when such a state is reached would be high. Therefore, one skilled in the art would not know how to make and use the invention as it is unclear at what point an optimal steady state occurs in order to capture the valve positions at that point.
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 1-2, 6-7, and 10-11 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 term “optimal” in claims 1 and 6-7 is a relative term which renders the claim indefinite. The term “optimal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification merely recites the term “optimal steady state” but fails to provide a basis as to how an optimal stability state differs from a normal operational state. As such, it is unclear at what point during the process the state would become “an optimal stability state.”
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/PETER KEYWORTH/Primary Examiner, Art Unit 1777
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