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 .
DETAILED ACTION
Status of the Claims
Claims 1-9 are pending and the subject of this FINAL Office Action.
New Grounds of Rejections - 35 USC § 112- Indefiniteness
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.
Claims 1-9 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The apparatuses required by the claims are too ambiguous to apply prior art without conjecture as to their scope. When the claims become so ambiguous that one of ordinary skill in the art cannot determine their scope absent speculation, such claims are invalid for indefiniteness. See In re Steele, 305 F.2d 859, 862 (CCPA 1962). Claim 1 is representative and recites:
1. A liquid chromatographic data processing apparatus comprising a data processing unit configured to generate: display data representing a multidimensional graph that correlates analytical condition data and analytical characteristic data of a chromatographic apparatus,
wherein the analytical condition data includes diameter of particles (dp) of a column filler, and
the analytical characteristic data includes a separation performance index comprising a number of theoretical plates (N) and a sensitivity performance index comprising a height-length product (Σ).
First, the use of different transitional phrases creates confusion due to the principle of consistency. Applicants use “including,” but also use “comprising.” It is therefore unclear if Applicants intend these transitional phrases to yield different meanings. Applicants should use one transitional phrase, based on conventional transitional phrases. See MPEP § 2111.03.
Next, Applicants’ claims state that the “display data” only “represents” the “multidimensional graph.” The term “represent” means many different things, each of which is quite vague: to describe or present clearly; to serve as a sign or symbol of; to take the place of in some respect; to serve as a specimen, example, or instance of; to correspond to in essence. Thus, it is unclear in what way the “multidimensional graph” is “represented.” The Examiner suggests that Applicants amend the claim to state clearly “data processing unit configured to generate: a multidimensional graph.”
Next, the scope of both “analytical condition data” and “analytical characteristic data” is unclear. These phrases are simply never defined nor clearly circumscribed with any clarity in the specification. These are not phrases common in the liquid chromatography art. In fact, the Examiner cannot find them. Applicants seem to have invented these terms without defining them. Instead, the specification mentions them in passing (paras. 0045, 0051, 0054-55, 0073-74 & 0228-29). They might be specific equations (e.g. equation 16 at para. 0062). However, a specific equation does not define a broad, generic phrase.
Although the Examiner appreciate that Applicants have added parameters to each of “analytical condition data” and “analytical characteristic data,” yet even these are unclear. As to “analytical condition data” “including” (interpreted as open transitional phrase) diameter of particles of a column filter, this single parameter fails to fill in the scope of “analytical condition data.” In other words, it remains unclear what other “analytical condition data” may be encompassed. Yet, even more confusing is “analytical characteristic data.” Simply put, what is a “separation performance index” that includes a “theoretical plate (N)”? Although the specification uses this phrase, yet it never defines it. It is used in Equation 6 and Equation 27, yet, on its own, it remains unclear what plate, and why it is theoretical. The “separation performance index” is also never defined, its scope remaining unclear. An “index” can be many different things: a list; a number; a device that serves to indicate a value or quantity; a number or symbol or expression. Nor is it clear what, if any, prior art would apply based on this Applicant-created terminology with no clear definition. For example, are WO2014/030537 or US20220099639 relevant? And what is a “sensitivity performance index” that comprises a “height-length product (Σ).” Again, this phrase is never defined with any clarity. Paragraph 0058 states
As the name implies, the height-length product Σ is the product of the height H and the length, so it is wise. However, a really brilliant idea for the computation is that Σ is defined as a variable obtained by multiplying the height equivalent to a theoretical plate H, which is a performance index in the axial direction, by the column length L (Equation 11).
In this single statement there are two different meanings provided. Moreover, a product is generally understood as a result of a multiplication, not a summation; yet, the symbol sigma is generally understood as a summation function. Nor have Applicants clearly redefined sigma here. See MPEP § 2173.05(a)(III). Once again, the Examiner strongly encourages Applicants to recite the specific equations disclosed that seem to be the only “analytical condition data,” “analytical characteristic data,” “separation performance index” and “sensitivity performance index.”
Prior Art
The following prior art draws a correlation between particle size and HPLC performance and/or sensitivity: US 20160136544, paras. 0015, 0076; US20240279192, Example 3; US 20190145943, para. 0142; US 20210389287, para. 0005; US 20060219633, para. 0106; US 20090277254, para. 0005; Spec, Description of Related Art; WO2014/030537; US20220099639; US 3954608; US 3230167.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/YUNG-SHENG M TSUI/ Primary Examiner, Art Unit 1684
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