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 without traverse of Group II, claims 33-51 in the reply filed on 1/29/2026 is acknowledged. Claim 1 is withdrawn from consideration as being drawn to a non-elected invention.
Priority
This application is a CON of 16/741,471 filed 01/13/2020 now US PAT 11274340 which is a DIV of 15/066,139 filed 03/10/2016 now US PAT10563250 which claims benefit of 62/133,185 filed 03/13/2015.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/4/2023 and 10/26/2023 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on 3/10/2026 is acknowledged. These drawings are found acceptable by the examiner.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 33-51 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wong et al (WO 2014071322, May 2014, citation made of record on IDS filed 10/26/2023).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 33, Wong et al teach a kit for synthesizing and amplifying a mature small RNA cDNA, the kit comprising: a single-stranded adaptor comprising a 3' terminal -OH group and a universal forward primer portion; a reverse transcription (RT) primer, wherein the RT primer comprises a poly(T) portion and a tail portion and wherein the tail portion comprises a universal reverse primer portion; and a universal forward and reverse primer pair, wherein the universal forward primer can hybridize to the universal forward primer portion or its complement, and the universal reverse primer can hybridize to the universal reverse primer portion or its complement (abstract, [0021], [00052] and [00087] – [00088]).
Regarding claim 34, Wong et al teach the kit of claim 33, further comprising one or more dNTPs, ATP, a buffer, and a salt of a divalent cation (claim 38 and claim 46).
Regarding claim 35, Wong et al teach a composition for detecting a mature small RNA comprising: a cDNA of a mature small RNA, the cDNA comprising a reverse transcription (RT) primer sequence at the 5' end and an adaptor sequence at the 3' end, wherein the RT primer comprises a poly(T) portion and a tail portion and wherein the tail portion comprises a universal reverse primer portion, and wherein the adaptor comprises a universal forward primer portion (Abstract and claim 52 and paragraphs [00014] – [00015], [00023], [00061], [000159]).
Regarding claim 36, Wong et al teach the composition of claim 35, further comprising a universal forward and reverse primer pair, wherein the universal forward primer can hybridize to the universal forward primer portion or its complement, and the universal reverse primer can hybridize to the universal reverse primer portion or its complement (Abstract and claim 52 and paragraphs [00014] – [00015], [00023], [00061], [000159]) .
Regarding claim 37, Wong et al teach the composition of claim 36, further comprising a DNA polymerase ([000102], [000107], [000110]. [000133]).
Regarding claim 38, Wong et al teach wherein the single-stranded adaptor comprising a 3' terminal - OH group and a universal forward primer portion is provided in solution ([000155]).
Regarding claim 39, Wong et al teach wherein the adaptor is an RNA molecule ([00019]. [0021] and [00052]).
Regarding claim 40, Wong et al further comprising one or more blocking oligonucleotides ([0010], [00021] – [000024]).
Regarding claim 41, Wong et al teach the kit of claim 40, wherein the blocking oligonucleotide is selected from the group consisting of a 3'-MGB blocking oligonucleotide, a 5'-MGB blocking oligonucleotide, a 2'-0- methyl blocking oligonucleotide, a 3'-acridine blocking oligonucleotide, a 5'-acridine blocking oligonucleotide, a STAR blocking oligonucleotide, and a blocking oligonucleotide comprising a poly(A) sequence ([00042] – [00047]).
Regarding claim 42, Wong et al teach the kit of claim 40, further comprising a single strand RNA ligase ([0006], [00021], [00052]).
Regarding claim 43, Wong et al teach the kit of claim 40, further comprising a reverse transcriptase ([00021], [000106] – [000107]).
Regarding claim 44, Wong et al teach the kit of claim 40, further comprising a DNA polymerase ([000102], [000107], [000110]. [000133]).
Regarding claim 45, Wong et al teach the kit of claim 40, wherein the poly(T) portion is disposed 3' of the tail portions in the RT primer ([0014] – [00015], [00021]).
Regarding claim 46, Wong et al teach the kit of claim 45, wherein the includes one additional nucleotide 3' of the poly(T) portion that is not a T ([000114]).
Regarding claim 47, Wong et al teach the kit of claim 40, wherein the RT primer is between 15 and 25 nucleotides in length ([000114]).
Regarding claim 48, Wong et al teach kit of claim 40, further comprising one or more additional primer pairs specific to a portion of the cDNA transcribed from a mature small RNA ([0001114]).
Regarding claim 49, Wong et al teach the kit of claim 40, further comprising a labelled detector probe ([000161]).
Regarding claim 50, Wong et al teach the kit of claim 40, further comprising a Poly(A) polymerase ([00033], [00042] and [00068]).
Regarding claim 51, Wong et al teach the kit of claim 40, wherein the RNA ligase is RNA ligase I ([000103]). Therefore, Wong et al meets the limitation of the claims.
Double Patenting
8. 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.
9. Claims 33-38, 42-45, 48, 50-51 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10563250 {US Patent ‘250, used interchangeably herein}.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claim(s) because the examined 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).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the claims 33-37, 42-45, 48, 50-51 and the claims 1-5 of US Patent ‘250 are directed to a kit or composition for synthesizing and amplifying a mature small RNA cDNA, the kit comprising: in solution, a single-stranded RNA adaptor comprising a 3′ terminal —OH group and a universal forward primer portion; a reverse transcription (RT) primer, wherein the RT primer comprises a poly(T) portion and a tail portion and wherein the tail portion comprises a universal reverse primer portion; a single strand RNA ligase; a reverse transcriptase; a DNA polymerase; and a universal forward and reverse primer pair, wherein the universal forward primer can hybridize to the universal forward primer portion or its complement, and the universal reverse primer can hybridize to the universal reverse primer portion or its complement (see claim 1 of US Patent ‘250 and Claims 33, 42-45 of the instant invention).
The claim 34 of the instant invention embodies the limitation of claim 2 of US Patent ‘250.
The claims 35, 36, 48, 50 and 51 of the instant invention embodies the limitations of the claim 3 of US Patent ‘250.
The claims 36 and 38 of the instant invention embodies the limitation of the claim 4 of US Patent ‘250.
The claim 37 and 44 of the instant invention embodies the limitation of the claim 5 of US Patent ‘250.
The claims 33-38, 42-45, 48, 50-51 of the instant invention differs from the claims 1-5 of US Patent ‘250 in that the recited claims of the instant invention differ slightly in wording and are broader in scope than the claims of the US Patent ‘250. Thus, the claims 33-38, 42-45, 48, 50-51 of the instant invention falls entirely within the scope of the claims 1-5 of US patent ‘250.
As the court stated in In re Goodman, 29 USPQ2d 2010 (CAFC 1993), " a second application-- "containing a broader claim, more generical in its character than the specific claim in the prior patent"--typically cannot support an independent valid patent. Miller, 151, U.S. at 198; See Stanley, 214 F.2d at 153. Thus, the generic invention, as noted above is "anticipated" by the species of the patented invention. Cf., Titanium metal corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (holding that an earlier species disclosure in the prior art defeats any generic claims). This court's predecessor has held that, without a terminal disclaimer, the species claims preclude issuance of the generical application. "In re Van Ornum, 686 F.2d 937, 944, 214 USPQ 761, 767 (CCPA 1982); Schneller, 397 F.2d at 354".
Conclusion
10. No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA B WILDER whose telephone number is (571)272-0791. The examiner can normally be reached Flexible.
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/CYNTHIA B WILDER/Primary Examiner, Art Unit 1681