DETAILED CORRESPONDENCE
Summary
This is the initial Office Action based on the McElroy, et al. application filed with the Office on 29 October 2024.
Claims 22-41 are currently pending and have been fully considered.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The preliminary amendment filed on 6 January 2025, is acknowledged and has been entered.
Priority
The instant application is a continuation of US Patent Application No. 18/311,005, filed on 2 May 2023, which is a continuation patent application from US Patent Application No. 16/549,946, filed on 23 August 2019, which claim priority to two US Provisional Patent Applications, 62/797,127 (filed on 25 January 2019) and 62/722,017 (filed on 23 August 2018). Thus, the effect filing date of the instant application is 23 August 2018.
Information Disclosure Statement
The information disclosure statement (IDS) submitted regarding the present application filed on 3 June 2025, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS been considered by the Examiner.
Claim Rejections - 35 USC § 102
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 22, 25, and 37-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication to Onuma (US 2016/0077053 A1; hereinafter, “Onuma”).
Regarding claim 22, Onuma discloses a method for capillary electrophoresis (Abstract: “A method is provided for analyzing a sample using capillary electrophoresis”), comprising:
a) providing an analyte comprising one or more polypeptides or a solution comprising said analyte ([0038]: “Examples of the analysis component include hemoglobin (Hb), albumin (Alb), globulin (α1, α2, β, γ globulin), fibrinogen, and the like.”),
b) contacting the analyte or solution of step (a) with a sample loading buffer, thereby generating a sample [0053]: “The diluting liquid Ld is mixed with the sample Sa to form a mixed sample Sm. There is no particular limitation on the main component of the diluting liquid Ld.”),
c) loading the sample onto a capillary (Abstract: “In an introducing step, a predetermined amount of sample is introduced to an introducing tank linked to the capillary tube.”),
d) applying a voltage across the capillary to resolve the one or more polypeptides (Abstract: “In an electrophoresis step, electrophoresis is performed in the capillary tube while the sample is continuously supplied.”), and
e) detecting the one or more polypeptides ([0050]: “The detector 5 is for receiving light that has been transmitted through the capillary tube 27 of the analysis chip 2, and includes, for example, a photodiode, a photo IC, or the like.”),
wherein the sample loading buffer is a buffered aqueous solution comprising an acidic buffer selected from 2-(N-morpholino)ethanesulfonic acid (MES), 3 -(N-morpholino)propanesulfonic acid (MOPS), 2-Hydroxy-3 -morpholinopropanesulfonic acid (MOPSO), and N-(2-Acetamido)- 2-aminoethanesulfonic acid (ACES) and a basic buffer selected from Arginine and Bis-Tris Propane (BTP) ([0054]: “There is no particular limitation on the electrophoretic liquid Lm, but preferable examples thereof include those using an acid.”; [0054]: “Examples of the buffer type of the electrophoretic liquid Lm include MES, ADA, ACES, BES, MOPS, TES, HEPES, and the like.”; [0054]: “The electrophoretic liquid Lm preferably contains a weak base. Examples of the weak base include arginine, lysine, histidine, tris, and the like.”).
Regarding claim 25, Onuma teaches “Examples of the buffer type of the electrophoretic liquid Lm include MES, ADA, ACES, BES, MOPS, TES, HEPES, and the like.” ([0054]).
Regarding claim 37, Onuma teaches “Examples of the analysis component include hemoglobin (Hb), albumin (Alb), globulin (α1, α2, β, γ globulin), fibrinogen, and the like.” ([0038]), which are polypeptides.
Regarding claims 38 and 39, the designation "the analyte comprises rituximab or golimumab" is directed to an analyte that is not part of the claimed buffer. Here, the buffer as taught by Onuma is capable of being used as sample loading buffer for analyzing an analyte comprising rituximab or golimumab because it is the same buffer as the instantly claimed buffer having all compositional limitations and appropriate pH value as claimed. Thus, this designation does not carry patentable weight to distinguish the claimed sample loading buffer from that in the prior art.
Regarding claim 40, the technique taught by Onuma is capillary zone electrophoresis. ([0068], [0069]).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 23 and 33-36 are rejected under 35 U.S.C. 103 as being unpatentable over Onuma.
Regarding claims 23, Onuma teaches the electrophoretic liquid has a pH of, for example, 4.5 to 6 ([0054]).
Onuma does not teach the pH of about 6.0 to about 7.7.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Onuma by adjusting the buffer within the claimed pH range of about 6.0 to about 7.7 because pH of 6.0 is a suitable pH value for the buffer being used as an electrophoretic liquid as taught by Onuma. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05(I). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America V. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP 2144.05(I).
Regarding claim 33 and 34, Onuma teaches the electrode 31 and the electrode 32 are for applying a predetermined voltage to the capillary tube 27 in the electrophoresis method. The electrode 31 is inserted into the introducing tank 23 of the analysis chip 2, and the electrode 32 is inserted into the discharging tank 25 of the analysis chip 2. There is no particular limitation on a voltage applied to the electrode 31 and the electrode 32, and examples thereof include a range of 0.5 kV to 20 kV. ([0048])
Regarding claims 35 and 36, Onuma teaches the limitation of instant claim 22, as outlined above.
While Onuma does not explicitly compare the sensitivity of the taught method versus a method performed using 100 mM Tris-HCl, 1.0% SDS, pH 9.0 as the sample loading buffer. However, the sensitivity of the method would be derived from the chemical characteristics of the taught buffer components. Therefore, it would be obvious that the taught method would have the claimed sensitivity, as the chemical properties are inherent to the compounds present. A similar argument is present as to the fragmentation versus the claimed comparison.
Claims 24, 26, 28, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Onuma as applied to claim 22 above, and further in view of a US Patent Application Publication to Singer (US 2018/0202968 A1; hereinafter, “Singer”).
Regarding claim 24, Onuma teaches the electrophoretic liquid has a pH of, for example, 4.5 to 6 ([0054]).
Onuma does not teach the pH of about 7.0 to 7.4.
However, Singer teaches a liquid medium that is capable of conducting the electric current ([0160] lines 1-2) for performing electrophoresis ([0019] line 2). The pH of the liquid medium may lie in a range selected from 6.75 to 8 ([0160] lines 19-21). The pH depends on the target analyte and suitable pH values are known to the skilled person ([0160] lines 21-23), rendering the pH value a result-effective variable that can be optimized tailored to different target analytes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Onuma by optimizing the pH value of the buffer in the claimed range as suggested by Singer because the pH value of the buffer is an experimental condition depending on the target analyte ([0160] lines 21-22), which is a result-effective variable and can be optimized through routine experimentation for performing electrophoresis. MPEP 2144.05 (II)(B). Furthermore, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05(I). Similarly, a prima facie case of obviousness exists where the claimed ranges or amount do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F .2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP 2144.05(I).
Regarding claims 26 and 31, Onuma does not explicitly disclose the concentration of the acidic buffer is about 50 mM.
However, Singer teaches a liquid medium that is capable of conducting the electric current ([0160] lines 1-2) for performing electrophoresis ([0019] line 2), which is an aqueous medium and comprises a buffer agent, like MOPS ([0160] lines 2-4). Here, MOPS is an acid and inherently acidic. The buffering agent may be comprised in a concentration in a range of 1 mM to 50 mM ([0160] lines 8-11). A suitable concentration can be determined by the skilled person ([0160] lines 12-13), rendering the concentration a result-effective variable that can be optimized to obtain a suitable concentration for performing electrophoresis.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Onuma by optimizing the concentration of the buffer agent, e.g., the acidic component MOPS, of the buffer in the claimed range as suggested by Singer because the concentration of the buffering agent is an experimental condition for performing electrophoresis, which is a result-effective variable and can be optimized through routine experimentation. MPEP 2144.05 (II)(B). Furthermore, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05(I). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America V. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP 2144.05(I).
Regarding claims 28 and 32, Onuma does not explicitly disclose the sample loading buffer comprises one or more of ethylenediaminetetraacetic acid (EDT A), sodium dodecylsulfate (SOS), and glycerol.
However, Singer teaches a liquid medium that is capable of conducting the electric current ([0160] lines 1-2) for performing electrophoresis ([0019] line 2). The liquid medium may also comprise a chelating agent like EDTA ([0160] lines 18-19), for example, at 10 mM EDTA in the MOPS buffer ([0392] lines 1-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Onuma by incorporating EDTA into the buffer as taught by Singer because EDTA is a commonly used chelating agent for making buffers. Combining prior art elements according to known methods to yield predictable results is prima facie obvious. MPEP 2141(lll)(A).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Onuma as applied to claim 22 above, and further in view of a US Patent Application Publication to Dolnik (US 2013/0001084 A1; hereinafter, “Dolnik”).
Regarding claim 27, Onuma teaches the limitations of instant claim 22, as outlined above.
Onuma does not explicitly disclose the basic buffer is Bis-Tris Propane (BTP) buffer.
However, Dolnik teaches electrophoretic separation in bare capillaries and channels with suppressed electroosmotic flow ([0036] lines 1-3) and the composition of a background electrolyte comprising boric acid and polyol bases ([0036] lines 4-6). The used buffer in examples for SOS capillary electrophoresis (Example 9, [0156] lines 1-2: for model proteins; Example 10, [0158] lines 1-2: for ovalbumin isoforms) is Bis-Tris Propane borate buffer. Thus, Dolnik teaches a buffer comprising a basic Bis-Tris Propane (BTP) buffer.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Onuma by substituting the tris buffer with the BTP buffer as taught by Dolnik because BTP buffer is a suitable buffer component for SOS capillary electrophoresis (Examples 9, 10; [0156] lines 1-2; [0158] lines 1- 2). The selection of a known material, i.e., the BTP buffer, based on its suitability for its intended use supported a prima facie obviousness determination. Sinclair & Carroll Co. v. lnterchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). MPEP § 2144.07.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Onuma as applied to claim 22 above, and further in view of a US Patent to Grover (US 6,083,372).
Regarding claim 30, Onuma teaches the limitations of instant claim 22, as outlined above.
Onuma does not explicitly disclose the sample loading buffer has a
conductivity of 2.0 mS/cm or less.
However, Grover teaches reagents and methods of performing electrokinetic chromatography (Col. 1, lines 12-13), in which EKC (electrokinetic chromatography) is a subset of capillary electrophoresis (Col. 3, lines 19-20). MEKC is usually performed with sodium dodecyl sulfate (SOS) micelles (Col. 3, lines 49-50), which is deemed to be CE-SOS. The capillary electrophoresis reagent comprises an aqueous phase (Col. 5, lines 9-11) containing surface active agent and buffering means that has a conductivity of 0.1 to 2.5 mS/cm (Col. 5, lines 24-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Onuma by adjusting the buffer having a conductivity of 2.0 mS/cm or less as suggested by Grover because the buffer having such a conductivity is suitable for performing CE-SOS. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05(I). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP 2144.05(l).
Allowable Subject Matter
Claims 29 and 41 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.
The following is a statement of reasons for the indication of allowable subject matter: the Onuma reference is considered the closest prior art to the instant claims. However, Onuma does not anticipate or render obvious the sample buffer containing sodium dodecylsulfate (SDS), as required by each of claims 29 and 41.
Interview with the Examiner
If at any point during the prosecution it is believe an interview with the Examiner would further the prosecution of an application, please consider this option.
The Automated Interview Request form (AIR) is available to request an interview to be scheduled with the Examiner. First, an authorization for internet communications regarding the case should be filed prior or with an AIR online request.
The internet communication authorization form (SB/0439), which authorizes or withdraws authorization for internet-based communication (e.g., video conferencing, email, etc.) for the application must be signed by the applicant or the attorney/agent for applicant. The form can be found at:
https://www.uspto.gov/sites/default/files/documents/sb0439.pdf
The AIR form can be filled out online, and is automatically forwarded to the Examiner, who will call to confirm a requested time and date, or set up a mutually convenient time for the interview. The form can be found at:
https://www.uspto.gov/patent/uspto-automated-interview-request-air-form.html
The Examiner encourages, but does not require, interviews by the USPTO Microsoft Teams video conferencing. This system allows for file-sharing along audio conferencing. Microsoft Teams can be used as an internet browser add-on in Microsoft IE, Google Chrome, or Mozilla Foxfire, or as a temporary Java-based application on these browsers. Steps for joining an Examiner setup Microsoft Teams can be found at the USPTO website:
https://www.uspto.gov/patents/laws/interview-practice#step3
Additionally, a blank email to the Examiner at the time of a telephonic interview can be used for a reply to easily allow for Microsoft Teams communication. Please note, policy guidelines regarding Internet communications are detailed at MPEP §500-502.3, and office policy regarding interviews are detailed at MPEP §713.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN C BALL whose telephone number is (571)270-5119. The examiner can normally be reached M - F, 9 am - 5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached at (571)272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J. Christopher Ball/ Primary Examiner, Art Unit 1795
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