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 II, claims 2-9 in the reply filed on 4/1/2026 is acknowledged. The traversal is on the ground(s) that the claims are linked to form a single general inventive concept. This is not found persuasive for the reasons made of record in the previous office action.
The requirement is still deemed proper and is therefore made FINAL.
Claim 1 is withdrawn from consideration as being directed to a non-elected invention. Claims 2-9 are examined herein.
Claim Rejections - 35 USC § 112
112(b)
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.
Claims 8 and 9 are rejected under 35 U.S.C. 112(b) 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 8 recites trademarks. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe fluorescence and quencher molecules and, accordingly, the identification/description is indefinite.
Claim 9 depends from the kit of claim 2, however it only recites method steps. Accordingly, the additional components of the kit are unclear. Additionally, the format of the steps are unclear in that they recite broad limitations, followed by narrower limitations (eg S3: DNA amplification, amplifying the synthesized cDNA). A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 9 depends from the kit of claim 2, however it only recites method steps and does not further limit claim 2. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 2-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhong (Zhong et al; Biosensors and Bioelectronics, vol 214, pages 1-6; June 2022).
It is noted that the instant application is a 371 which claims foreign priority to CN202210420863.9 filed 4/21/2022. However no translation of the foreign priority document has been provided. Accordingly, the effective filing date of the instant application is 3/21/2023.
Zhong teaches a system for detecting miRNA including poly adenine polymerase, Cpf1, and a nucleic acid probe labeled with a fluorescent donor and quencher on the 3’ and 5’ ends of the probe (see whole document). Although Zhong does not disclose these elements as a “kit”, the term is not defined by either the specification or the claims and therefore does not distinguish the instant claims from the elements taught by Zhong.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-9 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (Chen, Siyu et al; Chem. Sci., vol 13, pp 2011-2020, January 2022) in view of Jet (Jet et al; Chem. Soc. Rev., Vol 50, pp4141-4161, 2021) and Ma (Ma et al CN111534641; 8/14/2020; cited in the IDS filed 11/15/2023, reference will be made to US2023/0193408 which is the English language equivalent publication).
Chen teaches detection of miRNA using a Cpf1 enzyme and a nucleic acid probe fluorescently labeled with a FQ system (see whole document). However, Chen does not teach polyadenylation of the miRNA, however Jet teaches that polyadenylation of miRNA with poly(A) polymerase (PAP) and that doing so allows the reverse transcription of all miRNAs using a universal primer. Therefore, it would have been prima facie obvious to the ordinary artisan prior to the effective filing date to have included the use of a PAP enzyme in the miRNA detection system of Chen because Jet teaches that it allows for the reverse transcription of all miRNAs using a universal primer. Chen and Jet do not teach packaging these components into a kit, however Ma teaches a Cpf1 system for detecting nucleic acids that also comprises Cpf1 and a nucleic acid probe. Ma teaches that the probe includes a fluorescent label and quenching group at the 5’ and 3’ ends, respectively. Ma teaches that the Cpf1 can be codon optimized. Ma teaches the fluorescent group can be 6-FAM and the quencher can be BHQ1. Ma teaches the probe can have the sequence TTTATTT (see para 0010-0013). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to have included the Cpf1 enzyme, single stranded probe, and PAP enzyme as taught by Chen and Jet in kit format as taught by Ma for the obvious benefit of providing the reagents necessary to perform a method of miRNA detection. The use of codon optimized enzymes is routine in the art, as exemplified by Ma, and therefor it would have been obvious to provide the enzymes necessary for the detection system as codon optimized.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to examiner Jehanne Sitton whose telephone number is (571) 272-0752. The examiner can normally be reached Mondays-Fridays from 8:00 AM to 2:00 PM Eastern Time Zone.
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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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/JEHANNE S SITTON/Primary Examiner, Art Unit 1682
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