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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, all of the positively claimed structural elements recited in claims 18-22, 24-25, 30, 32-33, 38-39, 42-44, 49-50, and 52 must be shown or the feature(s) canceled from the claim(s). Presently, there are no reference numbers, no labeling is provided for to indicate what corresponds to each of the positively claimed structural elements. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the specification includes legal phraseology such as the term “comprising”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
It is noted that the claims mention a target molecule (not defined as being any specific molecule), activator (not defined as any specific structure, substance, material, state of matter, etc. in the claim ), reporter molecule (not specifically defined in the claim), electrochemical signal (not structure, nor defined), transcriptional repressor (not specifically defined in the claim); transcriptional activator, small molecule, computer, sample, and distinct activator. However, none of the prior are positively claimed as structural elements of the invention, an apparatus. Although each of the prior are not specifically defined in the claims, it is noted that each of the prior are materials and/or articles intended to be, can be worked upon used with the invention. The claims are directed an apparatus not a process of use. There is no requirement for any detecting, activating, binding, producing, releasing, reporting, capturing, generating, switching, triggering, inducing, controlling, hybridizing, inhibiting, etc. nor any other actions, steps required to be performed in the apparatus claims. Process steps do not define the apparatus. Only claims 53-54 are directed to methods.
It is noted that the term “or” provides for alternative options, not requirements.
It is noted that the term “plurality” only requires two.
It is noted that the phrase, “one or more” only requires one.
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 18-22, 24-25, 30, 32-33, 38-39, 42-44, 49-50, and 52-54 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
As to claim 18, it is unclear how the elements listed after “comprising” define a detection system because there is no detector nor any other structure positively claimed that is capable of providing for any detection of anything.
As to claim 18, it is unclear what is structurally required to define “an upstream molecular circuitry system” and “a reporter system” because each of such systems are defined by any specific structural elements. It is noted that the term “system” is not any specific structure and furthermore, the respective names of such systems do not provide for any structure of such systems. This also applicable to each of the various other systems recited throughout the claims that are not defined by any definitive, specific structure(s) in the claims.
Furthermore, it is unclear what is structurally meant, required by the term “upstream” because such is not structurally defined in the claim. There is no relative structural basis provided for in the claim. There is no requirement for any “stream” to flow in any direction relative to any of the positively claimed structural elements (a-c) so as to determine what is considered as “upstream”.
Furthermore, although no activating of the upstream molecular circuitry system is required to be performed, it is unclear what is required to occur to for the upstream molecular circuitry system be considered as “activated”.
Claim 18 recites the limitation "the presence of a target molecule" in a. There is insufficient antecedent basis for this limitation in the claim. As noted above no unspecified “target molecule” is positively claimed as an element of the invention and is not required to be present anywhere. Furthermore, the “to produce” clause is directed to intended use. No “activator” is positively claimed as an element of the invention.
Although no reporter molecule is positively claimed as an element of the invention, it is unclear from where/what such molecule is intended to be released.
As to claim 18, it is presumed that applicant intends for the invention to comprise an electrode and a capture molecule (not specifically defined in the claim) bound to the electrode. If so, the claim should clearly recite such.
As to claim 18, it is unclear how the “wherein” (last) paragraph of the claim further structurally limits the invention because the paragraph does not provide for any further structural element nor any further structure of any prior positively claimed element (a-c). The entire paragraph is directed to intended use and/or process steps.
Dependent claims 19-22, 24-25, 30, 32-33, 38--39, 42-44, 49-50, and 53-54 are rejected via dependency upon a rejected claim.
As to claims 19-22, 24-25, 30, 32-33, 38--39, 42-44, 49-50, and 53-54, it is unclear what/which system is being referenced by “the system” and “said system” because claim 18 recites a detection system, an upstream molecular circuitry system, and a reporter system.
As to claim 19, what is structurally required of, considered to be “a cell-free system” because such is not specifically defined in the claim. It is unclear what applicant is attempting to exclude from being present, a cell as in a biological cell and/or some other structure that can be referenced as a cell because the claim does not specify such.
As to claim 20, it is unclear what is required of a system to be considered as “a multiplexed system” because such is not structurally defined in the claim.
The term “distinct” in claim 20 and 52 is a relative term which renders the claim indefinite. The term “distinct” 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. There is no relative nor definitive structural basis provided for to indicate what is structurally required of a detection system and activator to be considered as “distinct”.
Furthermore, it is unclear what is structurally nexus “a plurality of distinct detection systems” and “a detection system” of claim 18 because it is unclear if the plurality of distinct detection systems are inclusive of the detection system of claim 18 or if the detection system of claim 18 comprises “a plurality of distinct detection systems” (that are not specifically structurally defined in the claim). Therefore claim 20 as a whole is unclear and confusing.
As to claim 21 (and 24), it is presumed that the upstream system is intended to refer to the upstream circuitry system. If so, the claim should clearly recite such. Furthermore, it is unclear what is structurally required to define each of the respective sensors, inducible transcription system, and a system for generating a gRNA recited in the claim because the claim does not define each such sensor and system recited in the claim.
As to claim 22, it is unclear what is a trigger RNA sequence and trigger DNA sequence because such are not defined in the claim. It is noted that claim 22 is only further limiting if a synthetic toehold switch-based sensor is the alternative selected as being present from claim 21.
As to claim 24, see prior applicable rejections above such as each system (such as an inducible transcription system” not being structurally defined.
Claim 24 recites the limitation "the transcription". There is insufficient antecedent basis for this limitation in the claim. No transcription has been previously positively claimed a structural element nor specifically structurally defined in the claims. Furthermore, although what applicant intends for a transcription to be controlled by is not a structural element of the invention, it is unclear what is structurally required to be/define “a transcriptional repressor’ and “a transcriptional actuator” and what is required to be done such that the transcription is “controlled” be such because the claim does provide for such.
As to claim 25, it is unclear how the claim further structurally limits the invention because as noted above no transcription is required to be performed and “no transcriptional repressor’’ and “transcriptional actuator” are positively claimed as elements of the invention Furthermore “is specific for a small molecule” is directed to intended use. However, there is no indication as what to what further structurally required of anything by the phrase. The term “specific” does not provide for any structure anything can be subjectively considered as “specific”. See all claims reciting such term.
It is unclear what is further structurally required by claims 30 and 32-33 because the claims do not provide for any further structural element nor further structure of any positively claimed structural element. The claims are directed to the “activator” that is not positively claimed as a structural element of the invention.
It is unclear what is further structurally required by claims 38-39, 42, and 49 because the claims do not provide for any further structural element nor further structure of any positively claimed structural element. The claims are directed to the “the reporter molecule” that is not positively claimed as a structural element of the invention.
Furthermore, in claim 38, the phrase “comprises reporter molecule hybridized to…” appears to be grammatically incorrect and is confusing because it is unclear what is the nexus of “reporter molecule” recited in the phrase to previously recited “the reporter molecule”, if such are the same or different because the claim does not provide for such.
Furthermore, it is unclear the “a complementary inhibitory single-stranded DNA sequence (iDNA) is intended to be an element of the invention because reciting that something is hybridized to a sequence not previously positively claimed as element does not require the latter (iDNA) to be a structural element of the invention. Furthermore, it is unclear what is structurally required by the phrase “complementary inhibitory” because the claim does not provide for such.
As to claim 44, it is unclear if applicant intends for “a terminal thiol group” to be a structural element of the invention because reciting what is employed to perform coupling does not clearly indicate such. Furthermore, it is unclear what is further structurally required by, for such a group to be considered as “terminal” because the claim does not clearly define such. If applicant intends for the invention to comprise a thiol group and the thiol group is coupled to, couples the capture molecule to the electrode, then the claim should clearly recite such.
As to claim 49, see above applicable rejection. It is noted that what the unclaimed reporter molecule binds to does not further structurally define the invention. Furthermore, it is unclear what is the nexus of “a capture molecule” and “an electrode” recited in claim 49 to the “a capture molecule” and “an electrode” recited in 1c. It is unclear if such are the same or different because the claim does not clearly recite such.
Claim 49 recites the limitation " the detection of a generated electrochemical signal by an electrode”. There is insufficient antecedent basis for this limitation in the claim. No such detection and generation of any electrochemical signal is previously mentioned nor required to be performed, increased by anyone nor anything. Furthermore, it is unclear what is meant by “increases” because there is no relative basis provided for in the claim.
It is unclear what is further structurally required by claim 50 because the claim does not provide for any further structural element nor further structure of any positively claimed structural element. The claims are directed to the “the electrochemical signal” (presumptively, the detectable electrochemical signal of claim 18) that is not positively claimed as a structural element of the invention. Furthermore, what any signal is detectable by (a broad computer) does not further structurally define the instant invention. No computer is positively claimed as an element of the invention.
Claim 52 employs the same and/or similar language as claim 18 and further previously addressed claims dependent upon claim 18. Therefore, applicant should see the above applicable rejections of claim 18.
As to claim 52, in addition to the prior applicable rejections of claim 18 and further prior claims, it is noted that “one or more” only requires one. Therefore, it is unclear what is “one or more different RNA toehold switch-based sensor(s)” because such is not structurally defined in the claim and it is unclear what is required for the one sensor or sensors to be “different” because there is relative basis of comparison provided for in the claim that indicates what is required by the term “different”.
Claim 52 recites the limitation "each RNA toehold switch" in line 3. There is insufficient antecedent basis for this limitation in the claim. No such switch(es) has been previously positively claimed nor structurally defined in the claim. However, it is unclear what further structurally required by the phrase “specific to a target molecule that is an RNA sequence in sample” because the claim does not provide for such. No sample containing any RNA sequence is positively claimed as an element of the invention.
Furthermore, it is unclear what the phrase “and comprising an mRNA” in line 4 modifies because the claim does not state such. However, it is noted that no act of “encoding” a distinct activator is required to be performed. The activator is not claimed as an element of the invention and there is not indication as what is required by the term “distinct” because the claim does not recite such.
As to claim 52, in b. it is unclear what “each reporter system” is being referenced. If this is intended to refer to the one or more reporter systems, then the claim should clearly state such. Furthermore, it is unclear if it is intended for the invention to comprise an inhibitory single-stranded DNA (iDNA). If so, the claim should clearly recite such. Furthermore, the phrase “a sequence recognized by said restriction enzyme” does not provide for any further structure. There is no indication as what constitutes “recognizing”. However, there is no requirement for the unclaimed restriction enzyme to be present nor do any recognizing.
As to claim 52, in c. it is unclear what “each capture molecule” is being referenced. If this is intended to refer to the one or more capture molecules, then the claim should clearly state such. Furthermore, it is unclear if it is intended for “an electrode” to be an element of the invention because reciting that a captureDNA is coupled to an electrode does not require the electrode to be an element of the invention.
Furthermore, it is unclear what the phrase “and comprising a sequence complementary to said reporterDNA” modifies because the claim does not state such. It is further unclear what is required of a sequence to be “complementary to said reporterDNA because the claim does not provide for such.
As to claim 52, it is unclear what is further structurally required by the last paragraph beginning with “wherein” because the paragraph is directed to process steps, intended use. There is no requirement for any activating, releasing of the reporterDNA, binding, producing of any electrochemical signal, nor detecting of any such signal by any unclaimed electrode to be performed. The claim is directed to an apparatus not a process of use.
As to claim 52, in the last paragraph, it is unclear what/which reporter system is being referenced by the phrase “the reporter system” because the claim previously recites “one or more reporter systems”.
As to claims 53-54 see prior applicable rejections above. It is noted that “said system” is not directed to any specific structure. Therefore, it is unclear what the sample is required to contact.
Claims 53-54 recite the limitation "the molecular-based detection system of claim…." in a. There is insufficient antecedent basis for this limitation in the claims.
As to claims 53-54, it is unclear what is the nexus of “a target molecule” to “a target molecule” in claim 18. Therefore, in claim 53, it is unclear which/what target molecule is being referenced by the phrase “the target molecule”. It is further unclear what is the nexus of the target molecule to the sample because the claim does not provide for such.
As to claims 53-54, in c. it is unclear which what signal is being referenced by “said signal” because claim 18 previously recites “an electrochemical signal detected by the electrode”. Furthermore, it is noted that the claims do not specify who, what, and how each of the steps a-c are performed. There is no requirement for the detecting to be performed by anything specific. It is unclear how the elements recited in claims 18 and 20 are employed to perform the methods of claims 53-54 because the claims do not clearly recite such. Furthermore, it is noted that any signal is considered by applicant as “indicating” does not further structurally limit the method. What such signal may be considered to “indicate” to one person may not be considered as such to another. The claim does not provide for any definitive basis such a numerical value of any signal. Therefore, it is unclear what is required of such signal to be an indication that a target molecule is present/detected.
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.
(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) 18-22, 30, 32-33, 38-39, 42-44, 49-50 and 53-54 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Soleymani et al., US 2022/0317082 (D1).
D1 discloses a biosensor for detecting an analyte (target molecule). (Abstract)
The biosensor has a first working electrode functionalized with biorecognition elements, such as DNAzymes, for the detection of target analytes by generating dual signal responses from a single redox species and another working electrode functionalized with a capture probe for receiving the reporter moiety with the single redox species. The electrodes can allow signals to be gathered from two channels (e.g. signal-on and signal-off channels) to increase the sensitivity, specificity and reliability of the biosensor. The nature of the electrodes can also facilitate the use of a single redox species as part of the reporter moiety (reporter system) to generate a dual response by its release (the reporter molecule (is released via an activator provided by an upstream molecular circuitry system) from one electrode and spatial movement to another electrode, where it can be captured. The signal changes of the two electrodes are correlated: analyte capture causes a signal decrease in the first electrode and a signal increase in the second electrode.
When the chip is exposed to the target analyte, the DNAzyme on the first working electrode cleaves at a ribonucleotide site in its sequence to release its redox-DNA reporter segment. This reporter then diffuses towards the second working electrode and hybridizes with the capture probe immobilized on this electrode (capture molecule bound to an electrode). (paragraphs 0007, 14, 28, 77-79).
As to claim 19, the biosensor and or systems of the biosensor are “cell-free”.
As to claim 20, the biosensor comprises a plurality of systems.
As to claims 21-22, D1 discloses aptamer based sensors. (paragraphs 0007, 14, 54, 59, 78).
As to claims 30 and 32-33 the activator is not positively claimed as a structural element of the invention.
As to claims 38 and 43, the reporter and capture molecules can be single-stranded DNA. (paragraphs 0060, 78).
As to claims 39, 42, and 49, the reporter molecule is not positive claimed as a structural element of the invention.
As to claim 44, a terminal thiol group can provide for immobilization of the capture molecule to the electrode. (paragraph 0110).
As to claims 49-50, the claims are directed to process steps that are not structural elements of the invention.
As to claims 53-54, each of the steps are provided for in D1 as noted above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Livak; Kenneth J.; HSING; I-Ming et al.; Gopinath; Ashwin et al.; Kelley; Shana O. et al.; Henkens; Robert W. et al.; INGBER; Donald E. et al.; and Vallee-Belisle; Alexis et al. disclose sensing/detecting systems comprising electrodes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798