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 .
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.
Claims 3, 4 and 10 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.
Regarding claims 3 and 4, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 10, The claim is generally narrative and indefinite, failing to conform with current U.S. practice. It appears to be a literal translation into English from a foreign document and is replete with grammatical and idiomatic errors. The claim is indefinite because it recites “according to the first aspect of the invention” which is unclear. Although claims are read in light of the specification, limitations from the specification are not imported and the claim should be complete in and of itself. Furthermore, even in view of the specification, under the recitation “in the first aspect of the present invention” there are many recited “preferred” embodiments and it is not clear if any or all of these are required for the claimed method.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to products of nature without significantly more. The claim(s) recite(s) sets of products wherein each element is derived from naturally occurring products, thus the claimed products are nature-based products. The markedly different characteristics analysis is used to determine if the nature-based products, are exceptions. The broadest reasonable interpretation of the claims encompasses combinations where all of the reagents are in separate containers as well as compositions containing components. There is no indication in the specification that the elements in the claimed combination take on any characteristics that are different from their naturally occurring counterparts. Thus, the mixture does not have markedly different characteristics from what occurs in nature, and is a “product of nature” exception. This judicial exception is not integrated into a practical application because the claims do not have any elements that are non-naturally occurring. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not have any elements that are non-naturally occurring.
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)(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.
Claim(s) 1, 3, and 5-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by EP 1759012B1.
The reference teaches a set of reagents that includes Bsu polymerase (DNA polymerase) T4 gp32 (single chain binding protein), a recombinase (uvsX), a reverse transcriptase (MuMLV RT) and a ribonuclease inhibitor protein (RNase inhibitor). The mixture additionally includes the loading protein UvsY and creatine kinase. Regarding claim 9, there is no special definition for a “kit” and so the collection of reagents taught by the reference is a kit.
See at least ¶0471:
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Thus, the reference anticipates claims 1, 3, and 5-9.
Furthermore, the reference teaches a method for reverse transcription amplification of RNA in a sample which includes preparing an amplification system including these reagents, and RNA template (MS2 RNA; ¶0469), and a primers (MS2UP and MS2DOWN) for amplifying a reverse transcription product of the RNA template, and carrying out amplification at an isothermal temperature (¶0413, ¶0011).
Claim(s) 1, 2, and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN106521032A, as evidenced by the TwistAmp DNA Amplification Kits combined instruction manual and Millipore Sigma product I5907 description. Paragraph numbers are according to the translation included with this Office action.
The reference teaches a set of reagents in a kit that includes a DNA polymerase, a single chain binding protein, and a recombinase, see ¶0189. The TwistAmp instruction manual evidences that all TWIST RPA kits include these elements (see at least manual Figure 1). CN106521032A further teaches the kit includes a reverse transcriptase, and a ribonuclease inhibitor protein (¶0192).
With regard to claim 2, the reference teaches the kit includes a pyrophosphatase (¶0192) namely Sigma catalog number I5907 (¶0137), which is an inorganic pyrophosphatase, inherently, see attached product description.
Thus, the reference anticipates claims 1, 2, and 9.
Claim(s) 1, 4, 9, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deshields et al. (American Journal of Potato Research (2019) 96:617–624).
The reference teaches a set of reagents in a method that employs a set of reagents that that includes a DNA polymerase, a single chain binding protein, and a recombinase, see Figure 1. The reference teaches including reverse transcriptase and RNaseOUT into the master mix (p. 621, 1st column). Thus, the reference anticipates claim 1.
The set of reagents employed in the reference also includes an exonuclease, namely Exonuclease III, see at least figure 1.
Regarding claim 9, there is no special definition for a “kit” and so the collection of reagents taught by the reference is a kit.
The reference teaches combining the reagents with a primer set, an RNA target and amplifying under an isothermal condition (p. 621, 1st column).
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 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 5 and 10 of copending Application No. 18713019 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application teaches each element of the copending claims see claims 3, 4, and 5. It does not teach them all in one claim, but it would have been obvious to have combined them in order to provide reagents for RPA, as suggested in claim 10. Furthermore, using the reagents to practice RPA for an RNA target, including adding primers and the RNA target would have been obvious in view of the teaching that these reagents are an “RPA” mixed enzyme system. The examiner takes Official notice that RPA is an isothermal amplification process, and that it requires primers to practice.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Juliet Switzer whose telephone number is (571)272-0753. The examiner can normally be reached Monday to Thursday, 8:00 AM-3:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Winston Shen can be reached at (571)-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Juliet Switzer
Primary Examiner
Art Unit 1682
/JULIET C SWITZER/ Primary Examiner, Art Unit 1682
Prosecution Insights