DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
2. Claim 9 is objected to because of the following informalities: “between captures;” at the end of the claim should be changed to “between captures[[;]].” (see MPEP 608.01(m): “Each claim begins with a capital letter and ends with a period.”). Appropriate correction is required.
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.
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.
4. Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,732,253. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-10 of U.S. Patent No. 11,732,253 teach all the steps and elements as recited in instant claims 1-15. Specifically, claim 1 of U.S. Patent No. 11,732,253 teaches all the steps and elements recited in instant claim 1 and is more specific; claim 7 of U.S. Patent No. 11,732,253 teaches all the steps and elements recited in instant claim 9 and is more specific. In addition, the other features as recited in instant claims 2-8 and 10-15 are also taught by claims 1-10 of U.S. Patent No. 11,732,253.
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.
6. Claims 1-8 and 15 are rejected 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.
Regarding claims 1-8
The term “low” in claim 1 (see lines 2-3: “…a low ionic strength buffer”) is a relative term which renders the claim indefinite. The term “low” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claims 2-8, each of which depends from claim 1, are also rejected for the same reason.
Regarding claim 15
Claim 15, dependent from claim 10 which depends from claim 9, recites the limitations “the cDNA” and “the mRNA” in the wherein clause. There is insufficient antecedent basis for these limitations in the claim. Since claim 14 recites “mRNA” and “cDNA”, claim 15 may be amended to depend from 14 (instead of claim 10) to overcome this rejection.
Claim Rejections - 35 USC § 102
7. 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 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.
8. 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.
9. Claims 9 and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tam et al. (Biotechnol. Prog. 2018, 34:1589-1595).
Regarding claim 9
Tam et al. teach, throughout the whole document, a method for capturing nucleic acids on a solid support, the method comprising repeatedly capturing and releasing (e.g., repeatedly capturing and releasing in the process of reaching hybridization equilibrium when the target capture “was performed at room temperature overnight”) nucleic acids (e.g., target DNA) on a solid support (e.g., magnetic bead coated with DNA probe) without denaturing or removing proteins between captures (see Figure 2; page 1591, column 1, paragraph 2; page 1591, column 2, paragraph 1).
Regarding claims 12-13
The method according to Tam et al., wherein the solid support is a bead, wherein the bead is a magnetic bead (see page 1591, column 1, paragraph 2; page 1591, column 2, paragraph 1; Figure 2).
10. Claims 1 and 9-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Karrer et al. (Proc. Natl. Acad. Sci. USA 1995, 92:3814-3818).
Regarding claim 1
Karrer et al. teach, throughout the whole document, a method for capturing RNA and DNA using a solid support, the method comprising: capturing mRNA on a solid support coated with an oligo dT (e.g., oligo(dT)-linked magnetic bead) in a low ionic strength buffer (e.g., RNA extraction buffer which has a relatively low ionic strength) (see Figure 2; paragraph bridging pages 3814-3815); releasing (e.g., releasing as part of repeatedly capturing and releasing in the process of reaching hybridization equilibrium when the mRNA capturing reaction was “incubated at 22 °C for 10 min”, or releasing via RNase H digestion after the first-strand cDNA synthesis) the captured mRNA (see Figure 2; page 3815, column 1, paragraph 2); and adding surfactant (e.g., Tween 20), salt (e.g., Tris[Symbol font/0xD7]HCl and EDTA) and a crowding agent (e.g., PEG 3350) then capturing DNA (e.g., capturing the double-stranded T7 adapter (which is DNA) via ligation to the double-stranded cDNA immobilized to magnetic bead) on the solid support (see page 3815, paragraph spanning columns 1-2; Figure 2).
Regarding claim 9
Karrer et al. teach, throughout the whole document, a method for capturing nucleic acids on a solid support, the method comprising repeatedly capturing and releasing (e.g., repeatedly capturing and releasing in the process of reaching hybridization equilibrium when the mRNA capturing reaction was “incubated at 22 °C for 10 min”) nucleic acids (e.g., mRNA) on a solid support (e.g., oligo(dT)-linked magnetic bead) without denaturing or removing proteins between captures (see Figure 2; paragraph bridging pages 3814-3815).
Regarding claims 10-11
The method according to Karrer et al., further comprising introducing surfactant to a sample comprising the nucleic acids before capture, wherein the surfactant is sodium dodecyl sulfate (SDS) (e.g., SDS contained in the RNA extraction buffer) (see paragraph bridging pages 3814-3815).
Regarding claims 12-13
The method according to Karrer et al., wherein the solid support is a magnetic bead (e.g., oligo(dT)-linked magnetic bead) (see Figure 2; paragraph bridging pages 3814-3815).
Regarding claims 14-15
The method according to Karrer et al., wherein the nucleic acids comprise mRNA and cDNA (e.g., cDNA synthesized after mRNA capture), wherein the first-strand cDNA is synthesized from the mRNA between captures (e.g., between mRNA capture and capturing of the second-strand cDNA) (see Figure 2; page 3815, column 1, paragraph 2).
Conclusion
11. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAIJIANG ZHANG whose telephone number is (571)272-5207. The examiner can normally be reached Monday - Friday, 8:30 am - 5 pm.
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/KAIJIANG ZHANG/Primary Examiner, Art Unit 1684
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