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 .
Information Disclosure Statement
The information disclosure statement filed October 12, 2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Copies of FOR references 1 and 4-9 have not been submitted.
Copies of NPL’s 1-73 have not been submitted.
Specification
The disclosure is objected to because of the following informalities: paragraph 0001, line 1, after “17/963,934,” should insert – now US patent 12.174,144, --; line 2, after “16/427.767,” should insert – now abandoned, --.
Appropriate correction is required.
Claim Objections
Claims 1 and 7 are objected to because of the following informalities:
- claim 1, “comprises” (line 3) should be – comprise --.
- claim 7, “filed” (line 1) should be – field --.
Appropriate correction is required.
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 1-21 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 pre-AIA the applicant regards as the invention.
Claim 1, “the focused analyte” (line 10) lacks antecedent basis. “[T]he focused analyte” should be – a focused analyte --.
Claim 1, “the focused and mobilized analytes” (lack antecedent basis. “[T]he focused and mobilized analytes” should be -- the focused analyte during mobilization [[and mobilized analytes]] --.
Claim 2, the catholyte and mobilizer have different conductivities is misdescriptive.
Claim 3, the catholyte has conductivity lower than the mobilizer is misdescriptive.
The specification discloses “introducing a mobilizer into the fluidic device from the second side channel; exposing the focused analyte to at least two different conductivity zones during mobilization via the first side channel and the second side channel” (paragraph 0013). However, the paragraph does not disclose the catholyte and mobilizer have different conductivities.
Claim 6 depends from claim 5 but contradicts claim 5 because claim 6 implies that there are two intersections by the first and second channel with the separation channel, respectively, while claim 5 recites one intersection by both side channels with the separation channel. Examiner made an effort to interpret two intersections in claim 6.
Claim 8, “the second channel” lacks antecedent basis and is read as – the second side channel --.
The remaining claims are also rejected under 35 U.S.C. 112(b), for being dependent upon a rejected base claim.
Note Regarding 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Pursuant to the 2019 Revised Patent Subject Matter Eligibility Guidance (MPEP 2106), the following analysis is made:
Under step 1 of the Guidance, the claims fall within a statutory category.
Under step 2A, prong 1, claim 1 do not recite an abstract idea.
Accordingly, claim 1 and its dependent claims 2-21 are patent eligible under 35 USC 101.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4-8, 10-13, and 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over Gentalen et al. (US 2019/0369068) in view of Gentalen et al. (US 2021/0046480).
Regarding claim 1, Gentalen et al. (‘068) discloses a method (Abstract) comprising:
loading a sample comprising at least one analyte of interest onto a fluidic device (paragraph 0130, lines 1-4; paragraph 0137, lines 21-23), wherein the fluidic devices comprises a fluid inlet (paragraph 0066, line 3), a fluid outlet (paragraph 0066, line 4), a separation channel (paragraph 0066, line 7), a first side channel (paragraph 0051, lines 7-9) and a second side channel (paragraph 0051, lines 5-7);
introducing the sample into the separation channel (paragraph 0010, lines 1-3);
introducing a catholyte into the fluidic device from the first side channel (paragraph 0051, lines 7-9);
separating the sample within the separation channel using isoelectric focusing (paragraph 0024, lines 2-3), wherein said separation generates at least one focused analyte peak (paragraph 0041, lines 3-4, 10-12);
introducing a mobilizer into the fluidic device from the second side channel (paragraph 0140, lines 1-5);
expelling the focused and mobilized analytes via the fluid outlet into a mass spectrometer (paragraph 0041, lines 1-5; paragraph 0012, lines 21-24; paragraph 0053, lines 1-6).
Gentalen et al. (‘068) does not disclose exposing the focused analyte to at least two different conductivity zones during mobilization via the first side channel and the second side channel.
Gentalen et al. (‘480) discloses exposing the focused analyte (mobilization of analyte corresponding to isoelectric focusing the current through separation channel, paragraph 0139, lines 1-6) to at least two different conductivity zones (conductivity for each of the separation channel, lines 3-4) during mobilization via the first side channel (catholyte side of separation channel, paragraph 0124, lines 7-9) and the second side channel (anolyte side of separation channel, paragraph 0124, lines 5-7).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Gentalen et al. (‘068) with separation channels having first sides and second sides as disclosed by Gentalen et al. (‘480) for the purpose of mobilization of analyte corresponding to isoelectric focusing the current through separation channel.
Regarding claim 4, Gentalen et al. (‘068) does not disclose exposing the focused analytes to the at least two different conductivity zones during mobilization results in increased resolution of the focused peaks during mobilization.
Gentalen et al. (‘068) discloses exposing the focused analytes to the at least two different conductivity zones during mobilization results in increased resolution of the focused peaks during mobilization (when performing isoelectric focusing, the use of switchable electrodes to trigger electrophoretic introduction of a mobilization electrolyte into separation channel may result in improved separation resolution, paragraph 0120, lines 7-11).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Gentalen et al. (‘068) with exposing the focused analytes to the at least two different conductivity zones during mobilization
as suggested by Gentalen et al. (‘480) for the purpose of improving separation resolution.
Regarding claim 5, Gentalen et al. (‘068) discloses the first side channel (406) and the second side channel (430) each intersect with the separation channel (418, Fig. 1) at a distal end of the separation channel (Fig. 1) close to the fluid outlet (424).
Regarding claim 6, Gentalen et al. (‘068) discloses the second side channel (430) intersects with the separation channel (418) at the distal end of the separation channel closer to the fluid outlet (434) as compared to where the first side (406) intersects with the separation channel (418).
Regarding claim 7, Gentalen et al. (‘068) does not disclose an electrical filed is applied to the separation channel during the mobilization.
Gentalen et al. (‘480) discloses an electrical filed is applied to the separation channel during the mobilization for mobilizing separated analysis bands (paragraph 0135, lines 13-16).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Gentalen et al. (‘068) with applying an electrical filed to the separation channel as suggested by Gentalen et al. (‘480) for the purpose of mobilizing separated analysis bands.
Regarding claim 8, Gentalen et al. (‘068) discloses the fluidic device comprises a substrate (402, Fig. 1), wherein the substrate (402) comprises a top surface (paragraph 0067, line 16), a bottom surface (paragraph 0067, line 16), and at least one side surface (paragraph 0067, line14-15), the separation channel (418) and the first side channel (406) and the second channel (438) are disposed between the top and bottom surfaces, and wherein the fluid inlet (412) extends to the at least one side surface (412 extends to one side surface of 402), which is not the top surface or the bottom surface (side surface of 402 is not top surface or bottom surface).
It is noted that the fluid outlet extends to the at least one side surface is an alternative limitation because it is recited in the alternative form.
Regarding claim 10, Gentalen et al. (‘068) discloses the catholyte and/or mobilizer comprise one or more of substances selected from the group consisting of phosphoric acid, sodium hydroxide, ammonium hydroxide, glutamic acid, lysine, formic acid, dimethylamine, triethylamine, acetic acid, piperidine, diethylamine, and combinations thereof (paragraph 0051, lines 9-14).
Regarding claim 11, Gentalen et al. (‘068) discloses the catholyte has a concentration of about 0.01%-about 0.9% (paragraph 0051, lines 7-9, 14-16).
Regarding claim 12, Gentalen et al. (‘068) discloses the catholyte comprises diethylamine and has a concentration of about 0.25% (paragraph 0051, lines 7-9, 13, 14-16).
Regarding claim 13, Gentalen et al. (‘068) does not disclose the mobilizer comprises acetic acid.
Gentalen et al. (‘480) discloses a mobilizer comprises acetic acid (paragraph 0209, lines 3-5).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Gentalen et al. (‘068) with a mobilizer comprises acetic acid as disclosed by Gentalen et al. (‘480) for the purpose of providing a mobilizer solution.
Regarding claim 16, Gentalen et al. (‘068) does not disclose the mobilizer is introduced continuously into the fluidic device from the second side channel during separating of the sample within the separation channel using isoelectric focusing and/or mobilization.
Gentalen et al. (‘480) discloses a mobilizer is introduced continuously into the fluidic device from the second side channel during separating of the sample within the separation channel using mobilization (the mobilization is performed by introducing an electrolyte into the separation channel from an electrolyte channel in fluid
communication, paragraph 0020, lines 42-46).
It is noted that the mobilizer is introduced … using isoelectric focusing is an alternative limitation because it is recited in the alternative form.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Gentalen et al. (‘068) with introducing a mobilizer into the fluidic device as disclosed by Gentalen et al. (‘480) for the purpose of performing mobilization.
Regarding claim 17, Gentalen et al. (‘068) discloses introducing an anolyte (paragraph 0131, lines 1-3).
It is noted that introducing at least one amphoteric compound, and/or a buffer onto the fluidic device are alternative limitations because they are recited in the alternative form.
Regarding claim 18, Gentalen et al. (‘068) discloses the fluidic device further comprises a third side channel (channel to 426, Fig. 1), wherein anolyte is introduced into the fluidic device via the third side channel (paragraph 0131, lines 1-3; Fig. 1).
Regarding claim 19, Gentalen et al. (‘068) discloses the fluid channel outlet (430/434) is in-line (Fig. 1).
It is noted that the fluid channel outlet is in fluid communication with an electrospray ionization interface is an alternative limitation because it is recited in the alternative form.
Regarding claim 20, Gentalen et al. (‘068) discloses the electrospray ionization interface is configured to interface with a mass spectrometer (paragraph 0053, lines 5-6).
Regarding claim 21, Gentalen et al. (‘068) discloses the at least one analyte of interest is selected from the group consisting of proteins, protein-drug conjugates, peptides, nucleic acid molecules, carbohydrate molecules, lipid molecules, metabolite molecules, small organic compounds, and any combination thereof (paragraph 0012, lines 27-31).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gentalen et al. (‘068) in view of Gentalen et al. (‘480) as applied to claim 1 above, and further in view of Gentalen et al. (US 20230176009).
Regarding claim 9, Gentalen et al. (‘068) as modified by Gentalen et al. (‘480) discloses the claimed limitations as discussed above, except imaging the separation channel or a portion thereof with a detector during or after the isoelectric focusing separation and/or mobilization.
Gentalen et al. (’009) discloses imaging the separation channel or a portion thereof with a detector after the isoelectric focusing separation (claim 13, lines 1-6).
It is noted that imaging the separation channel or a portion thereof with a detector during the isoelectric focusing separation is an alternative limitation since it is recited in the alternative form.
It is further noted that imaging the separation channel or a portion thereof with a detector during or after mobilization is an alternative limitation since it is recited in the alternative form.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to provide Gentalen et al. (‘068) as modified with a detector after the isoelectric focusing as disclosed by Gentalen et al. (‘009) for the purpose of imaging all/a portion of a fluid channel.
Allowable Subject Matter
Claims 2 and 3 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 14 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Reasons For Allowance
The following is an examiner’s statement of reasons for allowance:
The combination as claimed wherein a method comprising the catholyte and mobilizer have different conductivities (claim 2) or the catholyte is introduced continuously into the fluidic device … using isoelectric focusing (claim 14) is not disclosed, suggested, or made obvious by the prior art of record.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Nghiem whose telephone number is (571) 272-2277. The examiner can normally be reached on M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Schechter can be reached at (571) 272-2302. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/MICHAEL P NGHIEM/Primary Examiner, Art Unit 2857 January 28, 2026