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
Applicant’s election without traverse of Group III – claims 18-23 in the reply filed on 3/26/26 is acknowledged.
Claims 1-17 are withdrawn.
Specification
The disclosure is objected to because of the following informalities: the status of the parent application should be updated in paragraph [0001] of the specification.
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 21-23 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 21 is vague because it refers to “a buffer species” but is not clear what this buffer species is referring to and what its concentration means relative to the buffers recited in claim 20.
Claims 22 and 23 are vague because they refer to Table 2 instead of specifically setting forth what comprises the claimed stripping agent. The metes and bounds of the claim are not clear. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (MPEP 2173.05(s)).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 18-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 11 of U.S. Patent No. 11,143,650. Although the claims at issue are not identical, they are not patentably distinct from each other because patent ‘650 claims a method that uses the instant stripping buffer.
Patent ‘650 claims:
1. A method, comprising:
electrophoretically separating a sample containing a plurality of proteins in a microfluidic device;
immobilizing the plurality of proteins in the microfluidic device after electrophoretic separation;
introducing, into the microfluidic device, a molecule with a reactive moiety configured to non-specifically bind to proteins;
introducing, into the microfluidic device, a primary antibody configured to bind to at least a subset of proteins from the plurality of proteins;
introducing, into the microfluidic device, a secondary antibody configured to bind to the primary antibody;
detecting the subset of proteins based on an optical characteristic associated with the secondary antibody;
introducing, into the microfluidic device, a stripping reagent configured to remove the primary antibody from the subset of proteins;
introducing, into the microfluidic device, an optically detectable agent configured to bind to the molecule;
detecting an optical signal associated with the optically detectable agent; and
normalize the optical characteristic associated with the secondary antibody based on the optical signal associated with the optically detectable agent.
10. The method of claim 1, wherein the stripping reagent includes Tris(2-carboxyethyl)phosphine hydrochloride (TCEP) and has a pH between 3 and 4.5.
11. The method of claim 1, wherein the stripping reagent has a stripping efficiency of greater than 95% and includes a buffer formulation comprising a buffer selected from the group consisting of:
100 mM Glycine hydrochloride (HCl), 100 mM Tris(2-carboxyethyl)phosphine hydrochloride (TCEP); 2% sodium dodecyl sulfate (SDS);
200 mM Tris base, 100 mM TCEP, 2% SDS, 2% 3-[(3-cholamidopropyl)dimethylammonio]-1-propanesulfonate (CHAPS);
200 mM Glycine HCl, 100 mM TCEP, 2% SDS, 2% t-Octylphenoxypolyethoxyethanol;
60 mM Tris hydrocholoride (TrisCl), 100 mM TCEP, 2% SDS;
200 mM Glycine HCl, 100 mM TCEP, 2% SDS, 2% Polysorbate 20;
60 mM 2-(N-morpholino)ethanesulfonic acid (MES), 100 mM TCEP, 2% SDS;
60 mM 3-(N-morpholino)propanesulfonic acid (MOPS), 100 mM TCEP, 2% SDS;
60 mM TrisCl, 50 mM TCEP, 2% SDS;
200 mM Glycine HCl, 100 mM TCEP, 2% SDS, 2% Polyoxyethylene (23) lauryl ether;
60 mM N-(2-Hydroxy-1,1-bis(hydroxymethyl)ethyl)glycine (Tricine), 100 mM TCEP, 2% SDS;
50 mM 4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid) (HEPES), 100 mM TCEP, 2% SDS;
60 mM Tris base, 100 mM TCEP, 2% SDS;
200 mM Tris base, 100 mM TCEP, 2% SDS, 2% Polyoxyethylene (23) lauryl ether;
200 mM Tris base, 100 mM TCEP, 2% t-Octylphenoxypolyethoxyethanol;
200 mM Glycine HCl, 100 mM TCEP, 2% SDS, 0.5% Polysorbate 20;
75 mM Tris base, 100 mM TCEP, 2% SDS;
200 mM Glycine HCl, 100 mM TCEP, 2% SDS, 0.5% t-Octylphenoxypolyethoxyethanol;
50 mM Tris base, 100 mM TCEP, 2% SDS;
200 mM Glycine HCl, 100 mM TCEP, 2% SDS, 0.5% CHAPS; 200 mM Tris base, 100 mM TCEP, 2% SDS, 0.5% CHAPS;
200 mM Glycine HCl, 1200 mM TCEP, 2% SDS, 0.5% Polyoxyethylene (23) lauryl ether;
200 mM Tris base, 100 mM TCEP, 2% SDS, 0.5% t-Octylphenoxypolyethoxyethanol;
200 mM Glycine HCl, 100 mM TCEP, 1% lithium dodecyl sulfate (LDS);
50 mM Bicine 1,00 mM TCEP; 2% SDS;
200 mM Glycine HCl, 100 mM TCEP, 1% SDS;
200 mM Glycine HCl, 100 mM TCEP, 2% LDS;
200 mM Glycine HCl, 100 mM TCEP, 2% SDS;
200 mM Tris base, 100 mM TCEP, 1% SDS; 200 mM Tris base, 100 mM TCEP, 5% LDS;
200 mM Tris base, 100 mM TCEP, 2% SDS, 0.5% Polysorbate 20;
200 mM Tris base, 100 mM TCEP, 2% LDS;
100 mM Tris base 100 mM TCEP, 2% SDS;
150 mM Bicine, 100 mM TCEP, 2% SDS;
200 mM Tris base, 100 mM TCEP, 1% LDS;
100 mM Bicine, 100 mM TCEP, 2% SDS, 0.5% Polyoxyethylene (23) lauryl ether;
150 mM Tris base, 100 mM TCEP, 2% SDS;
200 mM Glycine HCl, 100 mM TCEP, 5% SDS;
200 mM Tris base, 100 mM TCEP, 2% SDS; and
200 mM Glycine HCl, 100 mM TCEP, 5% LDS.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 18-19 and 22-23 is/are rejected under 35 U.S.C. 102(a)(1) or 102(2) as being anticipated by Mechin et al (“An efficient solubilization buffer for plant proteins focused in immobilized pH gradients”, Proteomics, 2003, 3, 1299-1302; herein referred to as Mechin).
Mechin discloses a buffer comprising urea/thiourea, CHAPS (a detergent), DTT, Tris (2-carboxyethyl)phosphine hydrochloride (TCEP), and carrier ampholyte (a buffer) at pH of 4-6.5 (see Table 1 on page 1300).
With respect to the preamble of claim 18 calling the instant invention a “stripping buffer”, such a characterization of the instant buffer reflects a possible intended use. Since the buffer in Mechin is comprised of the same components as the instant buffer the buffer of Mechin could also be characterized as a “stripping buffer”.
With respect to claims 22 and 23, the buffer of Mechin contains the same components as the instant buffer and thus has the same properties as the instant buffer recited in claims 22-23.
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.
Claim(s) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mechin et al (“An efficient solubilization buffer for plant proteins focused in immobilized pH gradients”, Proteomics, 2003, 3, 1299-1302; herein referred to as Mechin) in view of Good et al (Hydrogen Ion Buffers, Methods of Enzymology, Vol. 24, 1972, 53-68; herein referred to as Good).
See above for the teachings of Mechin.
Mechin differs from the instant invention in failing to teach Hepes in the disclosed buffer.
Good teaches HEPES as one of the best general purpose buffers that can stabilize pH of media. HEPES is good for oxidative phosphorylation studies with plant mitochondria (i.e. protein studies) (pages 54 and 62).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add HEPES, as taught by Good, to the buffer of Mechin because HEPES provides the advantage of stabilizing pH. Also, the buffer of Mechin is for use with plant proteins and Good teaches that HEPES can be used with plant proteins. A person of ordinary skill in the art reasonably would have expected success because Mechin and Good are directed to buffers.
With respect to claim 21, it has been long settled to be no more than
routine experimentation for one of ordinary skill in the art to discover an optimum value
for a result effective variable. Where the general conditions of a claim are disclosed in
the prior art, it is not inventive to discover the optimum of workable ranges by routine
experimentation. Application of In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236
(C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process
by routine experimentation. Id. At 458, 105 USPQ at 236-237. The “discovery of an
optimum value of a result effective variable in a known process is ordinarily within the
skill of the art”. Applicant has not disclosed that the specific limitations recited in claims
21 are for any particular purpose or solve any stated problem. Absent unexpected
results, it would have been obvious for one of ordinary skill to discover the optimum
workable ranges of buffer concentration between 100-200 millimolar by normal optimization procedures known in the buffer art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L CHIN whose telephone number is (571)272-0815. The examiner can normally be reached Monday - Friday, 10:00am - 6:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
6/14/2026
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