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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 11, 2026 has been entered.
Status of the Application
2. Claims 49-76 are pending under examination. Claims 1-48 were canceled. The Applicant’s arguments drawn to obviousness type of double patenting over the claims in the co-pending application 17/284,542 filed on 9/30/2025 have been fully considered and found unpersuasive as indicated in the advisory action mailed on 10/02/2025. The rejection has been maintained and restated.
Double Patenting
3. 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.
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Claims 49-76 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 83, 87-92, 94, 96-105 of copending Application No. 17/284,542 (hereafter ‘542) in view of Wersto et al. (Cytometry, (communications in clinical cytometry), Vol. 46, p. 296-306, (2001)) and Wangh (US 2002/0178462).
Although the claims 49-76 at issue are not identical, they are not patentably distinct from each other because the claims are entirely within the scope of the claims of the co-pending application ‘542. Specifically, the method comprising chopping the tissue sample in nuclear extraction buffer comprising Tris lysis buffer, washing, centrifuging, resuspending the nuclear suspension buffer, filtering the resuspension through a strainer and sorting the nuclei comprising a portion of the rough endoplasmic reticulum are within the scope of the claims of the co-pending application ‘542. The only obvious variation of the instant claims to that of the claims in the co-pending application is use of scissors in chopping the tissue and resuspension buffer comprising 0.4% BSA.
Wersto et al. teach a method for tissue processing, wherein the method comprises chopping the tissue with scissors in ice-cold buffer to obtain finely minced tissue sample, disaggregating the cells, filtering nuclear suspension and staining and counting nuclei with a hemocytometer, wherein the tissue is obtained from breast carcinoma, lung carcinoma, and colorectal carcinoma sample (paragraphs under sample acquisition’ and ‘DNA staining’ on page 298).
Wangh teach a method for preparing nuclei from a biological sample, wherein the method comprises nuclei suspending buffer comprising 0.4% BSA and the said BSA is added to absorb/ stop protease and detergents treatments and to preserve genomic DNA intactness (para 0098, 0314, 0178, 0258). Wangh also teach red blood cell lysis buffer (hypotonic buffer) (para 0024, 0090).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of the claims in the co-pending application ‘542 with chopping tissue with scissors as taught by Wersto et al. and nuclear resuspension buffer comprising 0.4% BSA as taught by Wangh to develop an improved method for isolating and processing cell nuclei in a tissue sample. The ordinary person skilled in the art would have motivated to combine the teachings of the references and have a reasonable expectation of success that the combination would improve the sensitivity of the method because Wersto et al. explicitly taught an easy method collecting tissue, chopping the tissue into finely minced sample with scissors, disaggregating cells, counting nucleated cells for further analysis (paragraphs under ‘DNA staining’ on page 298) and Wangh explicitly taught use of 0.4% BSA absorb proteins and detergents from the pretreated sample and preserve genomic DNA
intactness (para 0098) and such a modification chopping the tissue with scissors and use of 0.4% BSA are considered as obvious variations over the cited art. This is a provisional nonstatutory double patenting rejection.
Response to Arguments:
With reference to the rejection of claims under obviousness type of double patenting over the claims in the co-pending application US 17/284,542 in view of Wersto et al. and Wangh et al., the Applicant's arguments were fully considered and found unpersuasive. With reference to the arguments drawn to no teaching of generating a barcoded nuclei or a single nuclei, sequencing and detecting expression of one or more genes, the arguments were found unpersuasive because the claims 83, 87, 89 in the co-pending application disclose chopping and generating multiple nuclei or single nuclei from a tissue and recovering single nuclei, before barcoding and sequencing which is within the scope of the instant claims 49 and 70 and are related as genus and species and co-extensive in scope. With reference to no teaching of washing the tissue with tris buffer, centrifuging to produce nuclear pellet and FACS sorting in claims in the co-pending application, the arguments were found unpersuasive because, the claims 83, 94 disclose, filtering, washing, transferring, recovering nuclei and sorting nuclei by FACS before barcoding and sequencing which is within the scope of the claims in the instant application as presented in claims 49-76. Further, the claims in the co-pending application disclose use of buffer comprising BSA. As discussed in the rejection it would be obvious to use scissors to chop tissue and optimize the concentration of BSA as recited in the instant claims as taught by Wersto and Wangh. For all the above the claims are obvious over the claims in the co-pending application and the rejection has been maintained.
Conclusion
No claims are allowable.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681
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