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 .
Detailed Action
This Office Action is in response to the Applicant’s reply received 2/17/26. Claims 11-17 are pending and considered on the merits.
Response to Applicant’s Arguments and Amendments
In the response submitted by the Applicant the following 35 U.S.C § 102/103 (a) rejections are withdrawn:
Claim(s) 11-17 were rejected under 35 U.S.C. 102(a)(1) or under 35 U.S.C. 103 as being anticipated by or obvious over Hillebrand (US 2011/0117628, in IDS 5/19/22 Ref A3) in light of support by two manuals from AnalytikJena (InnuPrep Virus RNA Kit-2013 and InnuPure C12 Extraction System-2011).
The Applicant’s Amendments including claim 11, step h) necessitated the above withdrawal. All arguments drawn to these rejections are now considered moot.
New Rejections Necessitated by Amendment
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) 11-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over --Hillebrand (US 2011/0117628, in IDS 5/19/22 Ref A3) in view of Rabinowits et al. (Clinical Lung Cancer, 2009) mirVana miRNA Isolation Kit (Ambion 2011).
Hillebrand teaches the isolation of nucleic acids including free or naked RNA from a sample [0047-0055, 0064] consisting of urine, serum or plasma [0047] comprising the following steps [0049-0054 and Example 1 and 2]:
Lysing the sample, if necessary, to free the nucleic acid [Example 1]
adding an aqueous alginate solution to the sample [Example 1 and 2];
adding an aqueous solution that induces gel formation which includes 1 M calcium chloride or 1% HCl.
mixing the gelled sample and briefly incubating it at room temperature
centrifuging the gelled sample and removing the supernatant
dissolving the gel fragment with 4M guanidine isothiocyanate [0081] or a basic low-salt buffer including 10 mM Tris-HCl (Trisodium citrate dihydrate) at pH of 9 [0055, 0074]
isolation of the concentrated free nucleic acids from the dissolved gel fragment
Hillebrand teaches these nucleic acids can be used in further downstream applications including diagnostics [0065, 0047]
Hillebrand et al. teach the samples can have free nucleic acids and not include viruses [0064-0064 and Exemplary Embodiment 1 and 2). Hillebrand teaches that alginates are the salts of alginic acids which are polyuronic acids [0026 and 0048]. He teaches the sample can be lysed prior to their nucleic acid isolation method [0064]. While Hillebrand does not expressly teach the gelled sample of iv) comprises microvesicles comprising RNA as limited in claim 11, step d). However this appears to be either inherent or obvious since Hillebrand executes the same steps as claimed, on the same RNA containing samples including blood, urine, or plasma.
What Hillebrand does not teach is investigating the miRNA and/or mRNA from microvesicles from tumor cells isolated from RNA. However this would be obvious in view of Robinowits et al. who teach screening exosome miRNA as a test for lung adenocarcinoma (Robinowits, Abstract, Conclusion). They teach isolating miRNA from the total RNA released from tumor exosomes from a blood sample (Robinowits, pg. 44, Patients and Methods) using a mirVana isolation kit. The protocol for this kit shows that miRNA is isolated from the total RNA after lysis of the sample (mirVana, see Fig 1).
It would be obvious for one of ordinary skill to use the method of Hillebrand to isolate the RNA for Robinowits et al. to analyze. Hillebrand et al. provides a method to isolate total RNA from a sample, and Robinowits et al. provides the method to isolate miRNA from the total RNA from a lysed sample. One of ordinary skill would recognized that the total RNA isolation from a sample by Hillebrand would be a known technique to improve the miRNA analysis of Robinowits et al. by providing a convenient method to isolate total RNA from a sample which can be subsequently processed to analyze the miRNA for lung adenocarcinoma (MPEP 2141 III (B)-(C)).
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 11-17 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9006420. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are drawn to methods of isolating nucleic acids (e.g. RNA) from a sample with the following steps:
adding an aqueous solution of alginate or polyuronic acid salt to the sample;
adding 1M of calcium ions or 1% acid to induce gel formation in the polyuronic acid solution;
centrifuging the sample to remove the supernatant to isolate the gel;
dissolving the gel with EDTA, a guanidinium salt, or citrate
recovering/isolating the nucleic acid from the gel;
While US’420 does not expressly teach the enrichment of exosomes, this is inherent since both sets of claims are preforming the same active steps on the same sample, and therefore should also produce the same results, including the enrichment of exosomes. Also while US’420 does not limit isolating nucleic acids instead of RNA, the current claims continue to overlap in scope since US’420 teach this method is suitable to isolate both DNA and RNA and steps (US’420, col 7, lines 15-20). While US’420 does not include a step of investigating the miRNA or mRNA from the isolated RNA, the two sets of claims continue to overlap because the isolation steps for the RNA match and are required for the investigation.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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