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 .
Election/Restrictions
Claims 3-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/10/2025.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 16-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dey (US 2014/0027625 A1; January 30, 2014).
Regarding claim 16, Dey discloses a method for calibrating a mass spectrometer (Paragraph 4-6) comprising:
a) obtaining a mass spectrum of a composition comprising a plurality of discrete polyethylene glycol compounds (dPEGs), wherein the plurality of dPEGs comprises a functional group that is ionizable under only one of positive mode ionization or negative mode ionization (Paragraph 4), wherein the plurality of dPEGs comprise one or more (I) dPEG-amine derivatives, (II) dPEG-carboxylic acid derivatives, (III) dPEG-sulfonic acid derivatives, and/or (IV) dPEG-phenolic derivatives (Paragraph 4-6);
b) determining the differences between the expected mass peaks for the plurality of dPEG derivatives in the composition, and the corresponding actual mass peaks in the mass spectrum (Paragraph 4-6); and
c) adjusting the mass spectrometer based on the differences between the expected mass peaks and the actual mass peaks (Paragraph 4-6).
Regarding claim 17, Dey discloses the method according to claim 16. Dey further discloses wherein the method calibrates the mass spectrometer in positive ionization mode or negative ionization mode (Paragraph 4-6- positive or negative ionization mode).
Regarding claim 18, Dey discloses the method according to claim 16. Dey further discloses wherein the calibrating further comprises determining the differences between an expected intensity for one or more of the plurality of dPEG derivatives in the composition, and the corresponding actual intensity of the one or more of the plurality of dPEG derivatives in the mass spectrum (Paragraph 32, Figure 3-6),
wherein the expected intensity is determined from a known concentration of the one or more of the plurality of dPEG derivatives, and adjusting the mass spectrometer based on the differences between the expected intensity and the actual intensity in the mass spectrum (Paragraph 32, Figure 3-6).
Regarding claim 19, Dey discloses the method according to claim 16. Dey further discloses wherein the mass spectrometer is an ESI spectrometer, an APCI mass spectrometer, or a MALDI mass spectrometer (Paragraph 32 - APCI).
Regarding claim 20, Dey discloses the method according to claim 19. Dey further discloses wherein the mass spectrometer is an APCI or an ESI (Paragraph 32 - APCI).
Regarding claim 21, Dey discloses the method according to claim 16. Dey further discloses wherein the method is performed in MS/MS mode (Paragraph 32 - MS).
Regarding claim 22, Dey discloses the method according to claim 16. Dey further discloses, wherein the method calibrates the mass spectrometer across a weight range of approximately 100 to 2500 Da (Paragraph 4-6).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GISSELLE GUTIERREZ whose telephone number is (571)272-4672. The examiner can normally be reached M-F 8-5:00PM.
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/GISSELLE GUTIERREZ/
Examiner
Art Unit 2884
/DAVID J MAKIYA/Supervisory Patent Examiner, Art Unit 2884