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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 08, 2025 has been entered.
Status of the Application
2. Claims 1, 5-7, 11-17 and 19-26 are pending under examination. New claims 29-30 are added. Claims 2-4, 8-10, 18 and 27-28 were canceled. The Applicant’s arguments and the amendment have been fully considered and found persuasive in view of the amendment.
Claim Rejections - 35 USC § 102-withdrawn
3. The rejection of claims under 35 USC 102(a)(1) as being anticipated by Frisen et al. has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 103-withdrawn
4. The rejection of claims under 35 USC 103 as being unpatentable over Frisen et al. in view of Scaboo et al. has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 112
5. 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 19 and 26 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. Claim 19 recites the limitation "the universal capture region" in line 1-2. There is insufficient antecedent basis for this limitation in the claim. The limitation (universal capture region) in the claim 19 lack antecedent basis because the claim 1 upon which the claim 19 depends does not have support for said limitation and it is not clear what the limitations are referring to. Further, claim 26 recites the limitation "the pair of capture probes" in line 4-7. There is insufficient antecedent basis for this limitation in the claim. The limitations in the claim 26 lack antecedent basis because the claim 26 does not have support for a pair of capture probes in the preceding lines of the clam and it is not clear if the limitations are referring to a pair of probes or to a pair of capture probes.
Double Patenting
6. 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 1, 5-7, 11-17, 19-26 and 29-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,913,975 (hereafter the ‘975) in view of Nguyen et al. (US 2014/0274756).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims 1, 5-7, 11-17, 19-26 and 29-30 are generic to claims 1-7 of the patent ‘975 or the claims 1, 5-7, 11-16, 19-26 and 29-30 are obvious over the claims 1-7 of the patent ‘975. Specifically, the method of claims 1, 5-7, 11-16, 19-26 and 29-30 comprising a capture array comprising a plurality of capture sites on a surface, wherein each capture site comprises a pair of probes, wherein a pair comprises a first probe comprising a first primer binding sequence and a spatial address region, which is unique sequence; and a second probe comprising a second primer binding sequence and a capture region and no spatial address region, wherein first probe does not comprise capture region are within the scope of the claims 1-7 in the patent ‘975. The claims 1, 5-7, 11-16, 19-26 and 29-30 recite a capture array for spatial detection and analysis of nucleic acids in a tissue sample, which is obvious over the claims 1-7 in the patent ‘975 which disclose a method using said capture array. However, the claims in the patent ‘975 do not teach that the capture sites have more first probes than the second probes.
Nguyen et al. teach a composition comprising an array comprising paired probes for analyzing nucleic acids in a tissue sample, wherein the paired probes comprise DNA probes (first probes) and RNA probes (second probes), wherein the array comprising paired probes have more DNA probes than the RNA probes (para 0014-0018).
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention, to modify the method of the claims as disclosed in the patent ‘975 with the inclusion of capture array comprising first probes more than the second probes as taught by Nguyen et al. to develop an improved method. 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 result in improving the sensitivity of the method because Nguyen et al. explicitly taught array having first probes more than second probes to simultaneously detect DNA and RNA with relatively increase the detection of the nucleic acid of interest (para 0016) and such a modification of the method is considered to be obvious over the cited prior art. Thus, the patented claims encompass the claims 1, 5-7, 11-16, 19-26 and 29-30 and are coextensive in scope.
Allowable Subject Matter
7. Claim 17 is 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.
Conclusion
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.
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, Gary Benzion can be reached at 571-272-0782. 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.
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681