DETAILED CORRESPONDENCE
Summary
This is the initial Office Action based on the Riehlman, et al. application filed with the Office on 19 February 2025.
Claims 26-47 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 .
Information Disclosure Statement
The information disclosure statements (IDSs) submitted regarding the present application filed on 23 September 2025 and 18 August 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDSs have been considered by the Examiner.
Two foreign references are lined through in the 18 August 2026 IDS, as copies of said foreign references were not submitted to the Office.
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 26-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 11 and 19 of U.S. Patent No. 12,259,355 (hereinafter, “355”). Although the claims at issue are not identical, they are not patentably distinct from each other. It is recognized that, generally, differences in concentration (wherein pH is a measure of the concentration of hydronium ions in solution) or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical (MPEP 2144.05 II A). Thus, concentration difference would be considered an "obvious to try" with the line of reasoning to be the determining the optimum or workable ranges (MPEP 2144.05 II B). Thus, patented claim 11 of 355 renders obvious the limitations of instant claims 26-29; patented claim 1 of 355 renders obvious the limitations of instant claim 30; patented claim 2 of 355 renders obvious the limitations of instant claim 31; and patented claim 19 of 355 renders obvious the limitations of instant claim 32.
Claims 30 and 31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 11,054,389 (hereinafter, “389”). Although the claims at issue are not identical, they are not patentably distinct from each other. It is recognized that, generally, differences in concentration (wherein pH is a measure of the concentration of hydronium ions in solution) or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical (MPEP 2144.05 II A). Thus, concentration difference would be considered an "obvious to try" with the line of reasoning to be the determining the optimum or workable ranges (MPEP 2144.05 II B). Thus, patented claim 1 of 389 renders obvious the limitations of instant claim 30; and patented claim 2 of 389 renders obvious the limitations of instant claim 31.
Claims 26-31, 44 and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 11, 12, 19 and 20 of U.S. Patent No. 12,253,490 (hereinafter, “490”). Although the claims at issue are not identical, they are not patentably distinct from each other. It is recognized that, generally, differences in concentration (wherein pH is a measure of the concentration of hydronium ions in solution) or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical (MPEP 2144.05 II A). Thus, concentration difference would be considered an "obvious to try" with the line of reasoning to be the determining the optimum or workable ranges (MPEP 2144.05 II B). Thus, patented claims 11 and 12 render obvious the limitations of instant claims 26-29; patented claim 1 renders obvious the limitations of instant claim 30; patented claim 2 renders obvious the limitations of instant claim 31; patented claim 19 renders obvious the limitations of instant claim 44; and patented claim 20 renders obvious the limitations of instant claim 45.
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 32-35 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.
Instant claim 32 recites the acronym “MCE” without defining the meaning of said acronym. Therefore, claim 32 is rejected as being indefinite for failing to particularly point out and distinctly claim the subject matter. Claims 33-35 each are dependent from claim 32, and are rejected for the same reasoning.
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 26-29 are rejected under 35 U.S.C. 103 as being unpatentable over a US Patent Application Publication to Fischer, et al. (US 2009/0233309 A1; hereinafter, “Fischer”).
It is recognized that, generally, differences in concentration (wherein pH is a measure of the concentration of hydronium ions in solution) or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical (MPEP 2144.05 II A). Thus, concentration difference would be considered an "obvious to try" with the line of reasoning to be the determining the optimum or workable ranges (MPEP 2144.05 II B).
Regarding claims 26-29, Fischer discloses an aqueous composition (claim 1) comprising one or more detergents present from about 0.1 % to about 1 % (wt./vol), one or more reducing agents present from about 0.05 M to about 0.3 M, and one or more buffers present from about 1 mM to about 1 M (claim 16), wherein the detergent may be lithium dodecyl sulfate, the reducing agent may be dithiothreitol, and the buffer may be phosphate buffer (claim 17). That the claimed composition is an electrophoresis sample buffer, or used to identify contaminants or impurities is considered the intended use of the claimed composition, which does not impart patentability.
Allowable Subject Matter
Claims 36-43 allowed.
Claims 46 and 47 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: No prior art reference was found which taught a) the sample buffer comprising 155 to 175 mM 2-iodoacetamide, 0.50 to 1.5% lithium dodecyl sulfate and 65 to 95 mM sodium phosphate, as required by pending claims 32-35; b) the method outlined in pending claims 36-42; and c) the written instructions for preparing a sample for microchip capillary electrophoresis, as required by pending claim 43.
Interview with the Examiner
If at any point during the prosecution it is believed 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 with 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J. Christopher Ball/ Primary Examiner, Art Unit 1795
Prosecution Insights