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
1.A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 15,2026 has been entered.
Status of the Application
2. Claims 1, 4-10 are pending under examination. New claims 11-14 are added. The Applicant’s arguments and the amendment have been fully considered and found persuasive for the following reasons.
Response to Arguments:
3. The rejection of claims under 35 USC 112(b) has been withdrawn in view of the amendment.
4. The rejection of claims under 35 USC 103 as being obvious over Williams et al. in view of Glezer et al. and Cracauer et al. has been withdrawn in view of the amendment.
Double Patenting
5. 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.
A. Claims 1 and 4-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of co-pending Application No. 18/361,797 (hereafter the ‘797). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims 1, 4-14 are within the scope of the claims in the co-pending application ‘787, specifically the method steps comprising method steps of performing a lab developed test (LDT) for detecting a first sample of a plurality of sample using user-defined a protocol that was preinstalled in a system and an invitro diagnostic test (IDT) on a second sample of the plurality of samples using system-defined parameters are within the scope of the claims are within the scope of the claims in the co-pending application ‘797. The only difference is that the claims recite a method and the claims in the co-pending application are drawn to a system comprising the method for performing LDT and IDT assays for a first and a second sample of the plurality of samples, which is considered as an obvious variation over the claims in the co-pending application ‘797. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
B. Claims 1 and 4-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26-33, 35-37, 40-55 and 57 of co-pending Application No. 18/361,763 (hereafter the ‘763) in view of Cracauer et al. (US 2008/0261220). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims 1, 4-14 are within the scope of the claims in the co-pending application ‘763, specifically the method steps comprising method steps of performing a lab developed test (LDT) for detecting a first sample of a plurality of sample and an invitro diagnostic test (IDT) on a second sample of the plurality of samples, wherein the first sample comprises a first analyte and second sample comprising a second form of the analyte are within the scope of the claims are within the scope of the claims in the co-pending application ‘763. However, the claims in the co-pending application do not teach user-defined and system-defined parameters.
Cracauer et al. teach automated nucleic acid detection assays comprising user selected protocols for specific in-vitro diagnostic assays, wherein the assay uses a protocol containing one or more system defined parameters comprising analyte-specific reagent assays (para 0023-0028, 0031-0035, 1103-1106, 1236-1263).
It would have been prima facie obvious to one of the ordinary people skilled in the art before the effective filling date of the invention to combine the claimed method of co-pending application ‘763 with using user-defined parameters and system defined parameters as taught by Cracauer et al. to perform automated assays for analyzing biological samples. The ordinary person skilled in the art would have motivated to combine the references and have a reasonable expectation of success that the combination would improve the sensitivity of the assays because Cracauer et al. explicitly taught use automated assays, wherein analyte specific reagent parameters or system-defined parameters and user-defined parameters to validate invitro diagnostic assays (para 1237-1263) and such a modification is considered obvious over the cited prior art. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SURYAPRABHA CHUNDURU whose telephone number is (571)272-0783. The examiner can normally be reached 8.00am-4.30pm.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681
Prosecution Insights