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 claim(s)
Claims 476-479, 481-493, 495 have been examined. Claims 476, 495 have been amended. Claims 1-475 and 494, 496-696 have been previously canceled.
Claim Rejections - 35 USC § 112
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 476-486 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. Claim limitation “identifying a second level pareto frontier”. However, the written description fails to disclose the corresponding structure, material to the function. The specification is devoid of adequate structure to perform claimed function. In particular, the specification states the claimed function of identifying a second level ….by filtering/filter. There is no disclosure of any structure, either explicitly or inherently, to identify a second level pareto frontier. The limitation filtering is not adequate structure for identifying a second level pareto frontier. And the specification does not provide sufficient details such that one of ordinary skill in the art would understand which filtering structure performs the claimed function. Therefore, the claim is indefinite and is rejected under 35 USC 112(b) or pre-AIA 35 USC 112, second paragraph.
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.
Claim 476 is 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. The disclosure does not provide adequate structure to perform the claim function of identifying a second level Pareto Frontier. There nowhere in the claim to provide adequate structure to perform claim function of obtaining trial design, evaluating the comparable score, filtering the design, communicating the pareto frontier design. The specification does not demonstrate that the applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail such that one of ordinary skill in the art can reasonably conclude that invention had possession of the claimed function.
Allowable Subject Matter Over the Prior Art
The primary reason for indicating allowability over the prior art is the inclusions of the following limitations in the combination as recited.
Claim 476 is directed towards a method comprising:
obtaining trial design simulation results for a set of trial designs;
determining a score for each trial design based on a performance criteria;
generating, for each score, a vector of values identifying a normalization function or a scoring function used to compute the score for each trial design;
identifying comparable scores by comparing the vectors of values for mismatches in the normalization function or the scoring function;
evaluating the comparable scores for each design in the set of trial designs to determine a Pareto frontier;
filtering designs that are not on the Pareto frontier;
communicating the Pareto frontier designs; and
identifying a second level Pareto frontier.
For claim rejection under 35 USC 103, the prior art closely relates to Fang-Fang Yin et al. (US 20160129282A1 hereinafter Fang-Fang Yin) in view of Walk et al. (US 20080234945A1 hereinafter Walk) and further in view of Fiege et al. (US 20130197878A1 hereinafter Fiege)). Fang-Fang Yin discloses to provide for dose prediction models that are established by learning from databases of patient treatment plans generated by human expert planners, Pareto-optimal plans generated by the multi-objective optimizations or similar systems, and by learning from published radiation treatment guidelines, personal treatment planning knowledge, etc. (‘282; Para 0053). Walk discloses a method for analyzing at least one test sample, wherein said test sample comprises at least one compound, said method comprising the steps of: a) providing at least one test sample comprising at least one compound; b) determining said at least one compound in said test sample whereby raw results are generated; and c) analyzing the raw results obtained in step b. Fiege discloses PARETO (Pareto-Aware Radiotherapy Evolutionary Treatment Optimization), makes use of a multi-objective genetic algorithm capable of optimizing several objective functions simultaneously and mapping the structure of their trade-off surface efficiently and in detail. PARETO generates a database of Pareto non-dominated solutions and allows the graphical exploration of trade-offs between multiple planning objectives during IMRT treatment planning PARETO offers automated and truly multi-objective treatment plan optimization, which does not require any objective weights to be chosen, and therefore finds a large sample of optimized solutions defining a trade-off surface, which represents the range of compromises that are possible.
However, the prior art does not disclose filtering designs that are not on the Pareto frontier; communicating the Pareto frontier designs and identifying a second level Pareto Frontier.
Claims 476-479, 481-493, is made 495 would be allowable if rewritten to overcome the rejection(s) under 35USC112(a) and 35USC 112(b), as set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Response to Arguments
Applicant’s arguments, see Remark, filed 05/26/2026, with respect to the rejection(s) of claim(s) 476, 487, 495 under 35USC112(a) and 112(b) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection under 35USC101 is made for claim 476.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2009/0292554 A1, Nov. 26, 2009; Schultz et al.; Method and Apparatus for planning and management of clinical trials.
WO 2019/144116 A1, July 25, 2019, Hoos, William Arthur et al.; Platforms for conducting virtual trials.
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/HIEP V NGUYEN/Primary Examiner, Art Unit 3686
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