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 .
Claims 21-25, 27-35 and 37-41 are currently pending and under examination.
Any objection or rejection of record in the previous Office Action, which is not addressed in this action has been withdrawn in light of Applicant’s amendments and/or arguments. This action is Final.
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 21-25, 27-35 and 37-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17-21 of USPN 12674157 in view of Fischer et al. (US 20090312285 A1) and further in view of Haydock et al (US 20130122496 A1). Instant claims 21, 31 and 41 are drawn to a method of disposing the biological sample and performing at least one nucleic acid analysis step on the mixture using a composition comprising guanidine thiocyanate, a polysorbate, PEG and buffer and dependent claims 22-30 and 32-40 are drawn to that method using a composition with concentrations of guanidine thiocyanate, polysorbate and its concentration, PEG8000 and its concentration, Tris buffer and its concentration, sodium acetate as buffer and its concentration. Claims 1 of USPN 12674157 is drawn to a composition comprising guanidine thiocyanate, a buffer selected from sodium acetate and Tris, a polysorbate, a zwitterionic surfactant, EDTA, an alcohol and at least one reducing agent selected form TCEP and DTT and combination thereof. Dependent claims recite limitations drawn to concentrations of guanidine thiocyanate, buffer, polysorbate-20, CHAPS as the zwitterionic surfactant, its concentration, ethanol and its concentration, further comprising and additional agent form SDS, PEG, an antifoaming agent a mixture of biological sample and the composition, specific biological samples, disposing the biological sample in the composition, and performing at least one step selected form shipping mixture to a clinical facility, storing the mixture for at least one week, and performing at least one nucleic acid amplification step on the mixture. The instant claims differ from patented claims in that the patented claims are drawn to a composition that has a zwitterionic surfactant, alcohol and a reducing agent also as components, whereas the composition used in the instant method claims does not have these components. Both Fischer and Haydock teach compositions that contain the additional components that are missing in the composition of the instant claims (Fischer paragraphs 0035-0036, 0021-0024 and Haydock paragraph 0035). Although the instant claims teach a method using a composition having only guanidine thiocyanate, a polysorbate, PEG and a base buffer, one of ordinary skill in the art would readily recognize that the method using the composition of the instant claims can be modified to arrive at the patented invention before its effective filing date with a reasonable expectation of success in view of Fischer and Haydock. The artisan would be motivated to make the composition used in the claimed method in order to look for a transport medium which will enhance the stability and integrity of the biological sample collected and dispersed in the medium (Fischer, para 0011). Haydock teaches that its compositions can be used to store nucleic acids while protecting against degradation and contamination (para 0005).
Response to Arguments
Applicant’s arguments and amendments, filed June 24, 2026, regarding the rejections of Claims 21-25, 27-35 and 37-41 on the ground of nonstatutory double patenting have been fully considered but they are not persuasive.
Applicant argues the instant claims are non-obvious over the combination of references. Applicant then states, “However, solely in order to expedite issuance of a patent from the subject application, a Terminal Disclaimer is being filed herewith which complies with each and every provision of 37 CFR § 1.321 and which disclaims the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on USSN 17/907,202. Thus, Applicant respectfully submits that the provisional double-patenting rejection of pending claims 21-25, 27-35, and 37-41 has been obviated by the filing of the Terminal Disclaimer and requests reconsideration and withdrawal of such provisional rejection of the claims.” This is not persuasive because no Terminal Disclaimer was filed. Additionally, co-pending application 17/907,202 has been patented and is now USPN 12674157. The NSDP rejection currently of record is not a provisional NSDP rejection.
Allowable Subject Matter
The claims are directed to a method where a biological sample present in a fluid-based collection medium is contacted with a fluidic sample preparation and reverse crosslink treatment reagent to form a fluidic mixture where the sample is placed. The reagent comprises guanidine thiocyanate, polysorbate, polyethylene glycol (PEG), and a base buffer that comprises either sodium acetate buffer having a pH in a range of from about 4 to about 6.5, or Tris buffer having a pH in a range of from about 8 to about 10. The fluidic mixture is then incubated. This method uses a single incubation step and the aforementioned single reagent to reverse crosslink, lyse and bind the nucleic acid in the sample. A nucleic acid analysis step is subsequently preformed on this resulting mixture. The claims require only a single step with a single fluidic reagent to carry out the three processes. The closest prior art is Narayanan et al (US 20160348153 A1) in view of Gundling (US 20140275510 A1). Neither Narayanan nor Gundling alone or in combination teach or render obvious the claims. The teachings of the closest prior art teach that the three process require multiple steps not a single step.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEATHER CALAMITA whose telephone number is (571)272-2876. The examiner can normally be reached Monday through Friday 8 AM to 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yvonne Eyler can be reached at 571.272.1200. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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HEATHER CALAMITA Ph.D
Supervisory Patent Examiner
Art Unit 1684
/HEATHER CALAMITA/ Supervisory Patent Examiner, Art Unit 1684
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