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 .
Election/Restrictions
Applicant's election with traverse of Group III and the species of STAT2 in the reply filed on 13 March 2026 is acknowledged. The traversal is on the ground(s) that the pending claims are linked by a common technical relationship involving patient-specific neural organoids for autism-related evaluation and treatment, together with a kit specifically adapted for carrying out that analysis. This is not found persuasive because Applicant has failed to traverse the Restriction with respect to the prior art that was applied in order to break Unity of Invention. Applicant indicates claims 19-20 read upon the elected invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-13, 22, and 24-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 19-20 are examined upon their merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application is the national state entry of PCT/US2020/056076 filed on 16 October 202, and claims the benefit of US Provisional applications 62/916,659 filed on 17 October 2019 and 62/916,201 filed on 16 October 2019.
Claims 19-20 have an effective US filing date of 16 October 2019.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 14, April 2022, 15 December 2025 and 13 March 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are considered by the examiner.
Claim Objections
Claim 19 is objected to because of the following informalities: MPEP 2173.05(s) states: “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table ‘is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.’ Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).” This is not one of those exceptional circumstances, and therefore the claims must be re-written to exclude reference to Tables.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Specifically, browser-executable code appears at paragraphs [0065], [0077], and [00156] of the specification. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 20 is 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 20 recites intended use that imposes no material limitation upon the scope of the claim. Claim 20 recites, a container “for collection of a tissue sample from a human.” The intended use does not define structural attribute(s) of the container (in contrast see MPEP 2173.05(g) where a kit “comprising components capable of being assembled” defined a structural attribute of the kit. In re Venezia, 530 F.2d 956, 189 USPQ 149 (CCPA 1976)). For purposes of applying prior art, the claim will be interpreted as reading upon any container, but does not require human tissue samples.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sun et al., Clinical and Experimental Pharmacology and Physiology, 34, 1097-1101, 2007.
Regarding Claim 19, the Sun et al. prior art teaches a kit comprising an array containing the sequences of the instantly-elected STAT2. The prior art discloses total RNA was isolated from tissues using TRIzol reagent (Invitrogen). Expression profiles were created using the superarray Q series JAK/STAT signalling pathway gene array (http://www.superarray.com/). These nylon filter arrays contain 96 known transcripts specific to Jak/STAT signalling pathways (pg. 1098, sections titled ‘RNA Isolation’ and ‘Gene Expression profiling’) See also Figure 1c of the reference, which teaches STAT2 of the instant claim in in the array (sixth column, fourth from the bottom).
Regarding Claim 20, the Sun et al. prior art teaches a container and reagents required for RNA isolation from the tissue sample, wherein it teaches total RNA was extracted using TRIZOL Total RNA Isolation Reagent (Invitrogen) (“reagents required for RNA isolation from the tissue sample “ of the claim) and aliquots (“container” of the instant claim) of total RNA (2 mg) were digested with RQ1 RNase-Free DNase (Promega, Madison, WI, USA) (see pg. 1098, section titled ‘Real-time quantitative PCR’).
Therefore, the elements of the claimed kit are taught by the prior art an, further, are all utilized together.
Reference cited but not relied upon as prior art:
Zeng et al., J Virology, 81(5): 2401-2417, 2007.
The Zeng et al. prior art reference teaches the same superarray Q series JAK/STAT signalling pathway gene array along with TRIzol reagents utilized in the Sun reference above (pg. 2402, last paragraph, RNA isolation), however, the prior art actually discloses methods of using this kit comprising human tissue samples.
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 19 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-21 of copending Application No. 17/047,179 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are directed to a kit comprising an array containing the sequences of one or a plurality of biomarkers listed in the claims 6, 7, 12, 13, 14, or 15 in a human patient; containing a container for collection of a tissue sample from a human (claim 20); and, reagents required for RNA isolation (claim 21). Claim 6 of the reference application recites Table 1, which includes the instantly-elected STAT2 (see Table 1, pg. 5 and Table 7, pg. 34).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 19 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-21 of copending Application No. 17/095,209 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims are directed to a kit comprising an array containing the sequences of one or a plurality of biomarkers listed in the claim 6 in a human patient. Again, Claim 6 of the reference application recites Table 1, which includes the instantly-elected STAT2 (see Table 1, pg. 5 and Table 7, pg. 34). Claim 20 is directed to the kit containing a container for collection of a tissue sample from a human; and Claim 21 is directed to reagents for RNA isolation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STACEY NEE MACFARLANE whose telephone number is (571)270-3057. The examiner can normally be reached M-F 7:30-5 (EST) & Sat. A.M..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STACEY N MACFARLANE/ Examiner, Art Unit 1675
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