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 .
Priority
The foreign priority claim filed on 12/01/2021 was not entered because the foreign priority claim was not filed during the time period set forth in 37 CFR 1.55. For original applications filed under 35 U.S.C. 111(a) (other than a design application) on or after November 29, 2000, the time period is during the pendency of the application and within the later of four months from the actual filing date of the application or sixteen months from the filing date of the prior foreign application. In addition, if the application was filed on or after September 16, 2012, the claim for foreign priority must be presented in an application data sheet. See 37 CFR 1.55(d)(1). For national stage applications under 35 U.S.C. 371, the claim for priority must be made within the time limit set forth in the PCT and the Regulations under the PCT. See 37 CFR 1.55(d)(2). If applicant desires priority under 35 U.S.C. 119(a)-(d), or (f), 365(a) or (b), or 386(a) based upon a prior foreign application, applicant must file a petition for an unintentionally delayed priority claim under 37 CFR 1.55(e). The petition must be accompanied by (1) the priority claim under 35 U.S.C. 119(a)-(d), or (f), 365(a) or (b), or 386(a) in accordance with 37 CFR 1.55 identifying the prior foreign application to which priority is claimed, unless previously submitted; (2) a certified copy of the foreign application, unless previously submitted or an exception under 37 CFR 1.55 applies; (3) the applicable petition fee under 37 CFR 1.17(m)(1) or (2); and (4) a statement that the entire delay between the date the claim was due under 37 CFR 1.55 and the date the claim was filed was unintentional. The Director may require additional information where there is a question whether the delay was unintentional. The petition should be addressed to: Mail Stop Petition, Commissioner for Patents, P.O. Box 1450, Alexandria, Virginia 22313-1450.
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.
Claim 1 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 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.
Claim 1 recites “wherein in the elution step, a use amount of the eluate is determined according to the humidity. The recitation fails to comply with the enabling as set forth by the factors in In re Wands 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1998) (see also MPEP § 2164.01(a) and § 2164.04).
(A) The breadth of the claims: Claim 1 broadly teaches the determination of a use amount to humidity, but fails to go into specifics where one of ordinary skill would not be able to successfully to make and/or use the invention without undue experimentation.
(B) The nature of the invention: The invention draws to a mass spectrometry method for measuring humidity.
(C) The state of the prior art: There is no prior art that was found that discusses a mass spectrometry method that correlates a use amount of eluate to humidity.
(D) The level of one of ordinary skill: A practitioner who has a master’s level in chemistry.
(E) The level of predictability in the art: The relevant art is unpredictable as there is no prior art that discloses a mass spectrometry method that correlation between a use amount of eluate and humidity.
(F) The amount of direction provided by the inventor: The inventor does not provide sufficient direction in the original specification that one skilled in the art could follow in attempting to make and/or use this invention. Specifically, there is no teaching of how an amount of eluate is correlated to humidity.
(G) The existence of working examples: The specifications provided by the instant application does not disclose working examples of the relevant element of humidity being found to determine a use amount of eluate.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure: The amount of experimentation needed based on the content of the disclosure would be substantial and undue in determining a use amount of eluate by using humidity.
In conclusion, based on the above Wands factor analysis, the claims fail to comply with the enablement requirement.
Additionally, dependent claims 2-8 fail to fulfill the enablement requirement as they do not add any specific information for carrying out the invention.
Claim 1 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 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.
Claim 1 recites “wherein in the elution step, a use amount of the eluate is determined according to the humidity.” The original specification does not disclose a clear correlation between a use amount of the eluate and the humidity, and while a relation is taught in the specification “the use amount of the eluate when the humidity is low is determined so as to be larger than the use amount of the eluate when the humidity is high.” (see [0052], page 8), it is not specific enough to clearly convey the claimed subject matter or show that the applicant had possession of this claimed limitation for how humidity is used for determining a use amount of eluate.
Additionally, dependent claims 2-8 fail to fulfill the written description requirement for the same reasons as claim 1.
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(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 1, recited in lines 1-2 “An analysis method comprising: a humidity measurement step of measuring humidity.”. However, the body of the claim fails to recite a step for measuring humidity.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Klein et al. (US PG-Pub 20040023289 A1) was the closest relevant art, teaching the analyte-containing gas phase brought into contact with the first carrier matrix, the analyte is bound to the first binding partner which is contained in the first matrix and not bound to the matrix, and the complex consisting of analyte and first binding partner and uncomplexed first binding partner are eluted from the first matrix (see Klein et al. [0015]-[0017]).
Additionally, Takats et al. (WO 2009144560 A1) was also found to be particularly relevant, disclosing a universal sample preparation method for desorption ionization mass spectrometry for volatile materials such as volatile solvents, and a SPEEDI elutor device and plate where measurements can take place (see Takats et al., Abstract, col. 8, lines 5-12, col. 10-11, lines 27-4, col. 19-20, lines 29-6).
The prior art combination of Klein et al. and Takats et al. fails to teach a humidity measurement step of measuring humidity; and a detection step of detecting the analyte by mass spectrometry, wherein in the elution step, a use amount of the eluate is determined according to the humidity.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tracy C Colena whose telephone number is (571)272-1625. The examiner can normally be reached Mon-Thus 8:00am-5:00pm.
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/TRACY CHING-TIAN COLENA/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797