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 .
Status of The Claims
Claim(s) 1-21 is/are pending and are under examination.
Applicant’s election with traverse of Group II, which includes Claims 4-7 and 13-21 in the reply filed on 04/06/2026 is acknowledged.
Restriction requirement from previous office actions is hereby withdrawn. Applicant’s argument is found persuasive. In particular, applicant argues that (1) Shum screens aptamers based on a principle of affinity and not reactivity with helicase; and (2) Shum's SELEX process involves single-stranded DNA libraries and not "duplexes."
Claim Rejections - 35 USC § 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.
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 9, 15, and 20 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 9 depends on claim 1 and recites “said switches are riboswitches”. However, claim 1 does not recite any “switches”. Claim 1 is directed to selecting aptamer substrates of helicase enzyme. Thus, the phrase “said switches are riboswitches” lack antecedent basis.
Claim 15 recites “A method for detecting a compound of interest, using the reporter system of claim 14”. However, amended claim 14 no longer recite a reporter system. Thus, the phrase “the reporter system of claim 14” lack antecedent basis.
Claim 20 depends on claim 5 and recites “the specific inducer is serotonin or a synthetic inducer”. However, the amended claim 5 limits the specific inducer to only natural inducer. Thus, it is unclear if claim 20 requires natural inducer or natural inducer and synthetic inducer.
As per MPEP 2173: It is of utmost importance that patents issue with definite claims that clearly and precisely inform persons skilled in the art of the boundaries of protected subject matter. Therefore, claims that do not meet this standard must be rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph as indefinite. Further, as per MPEP 2173.02: If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. As currently written, the metes and bounds of the rejected claims are unascertainable for the reasons set forth above, thus the above claim(s) and all dependent claims are rejected under 35 USC 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Claim Rejections - 35 USC § 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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 20 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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 20 depends from claim 5, which requires the specific inducer to be natural inducer. However, claim 20 recites the specific inducer is “serotonin or a synthetic inducer”. The “synthetic inducer” fails to further limit the scope of “natural inducer” limitation from claim 5. Thus, claim 20 is an improper dependent claim. 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.
Allowable Subject Matter
The following is an examiner’s statement of reasons for allowable subject matter:
The closest prior arts considered during examination includes Jang et al. (Biochem. Biophys. Res. Commun. 66.3 (2008): 738-744, disclosed in IDS). Jang teaches an in vitro SELEX process for isolating inhibitory RNA aptamers against SARS coronavirus NTPase/Helicase (nsP10) using an RNA library having random sequences of 40 nucleotides. Jang further teaches repeated rounds of selection, recovery, amplification, and enrichment of RNA aptamer pool inhibit helicase unwinding activity.
Regarding claim 1, Jang does not teach or suggest the claim process of claim 1. Jang’s SELEX selection is based on affinity association of RNA molecules with helicase, where in the non-binding RNA candidates are removed and the bound RNA candidates are recovered and amplified. Jang’s helicase unwinding assay is used to characterize the inhibitory potency of the selected candidates, not part of the selection criteria/condition. Meanwhile, claim 1 uses helicase-mediated duplex unwind/disassociation as the basis for selection and enrichment. Jang does not disclose or suggest this activity-based selection mechanism.
Claim 4 is different from claim 1 because it directed to selecting for switches, instead of aptamers, which regulate the activity of helicase in presence/absent of an inducer. Jang especially does not disclose this inducer-dependent selection. As discussed above, Jang’s method selects RNA aptamers based on affinity to the helicase and subsequently tests the selected candidates for inhibition potency. Jang does not teach the use of inducers during selection and does not teach selecting switches that regulate helicase activity in presence/absent of inducers. Accordingly, Jang does not disclose or suggest additional limitation of claim 4.
Conclusion
Instant claims 1-8, 10-14, 16-19, and 21 are allowable
Instant claims 9, 15, and 20 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Khai Quynh Tien Pham whose telephone number is (571)272-6998. The examiner can normally be reached M-T, 9-4 ET.
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/KHAI QUYNH TIEN PHAM/Examiner, Art Unit 1684
/JEREMY C FLINDERS/Primary Examiner, Art Unit 1684
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