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 .
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 1-15 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 claim 1, it is unclear how the claimed detector would detect the “presence” of the probe. The specification explains how the detector would detect a property of the probe (an optical signal/fluorescent intensity, or an oxidation-reduction potential), but it does does not provide clarity as to how the claimed detector would detect the “presence” of the probe. For this examination, the detector is being interpreted as any detector configured to detect a change in any parameter of the probe. The same indefiniteness issue is present in claims 7, 9, 12, 13, and 14.
Regarding claim 6, the phrase “and other gastrointestinal, GI, tract contents” renders the claim indefinite. For this examination, the phrase is being interpreted as “and other gastrointestinal (GI) tract contents”.
Claims not explicitly rejected above are rejected due to their dependence on a rejected base claim.
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 1-4 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al. (Highly sensitive electrochemiluminescence…).
Regarding claim 1, Yang et al. discloses a device for detecting enzymatic activity in mucus layer, wherein the device comprises: at least one mucin molecule corresponding to an enzyme of a first time (Scheme 1 on page 128; section 2.7. Fabrication of the ECL aptasensor on page 128: “Then, 10 µL of MUC1-aptemer compound and 10 µL of H2 were dropped onto the HT/H1/AuNPs/TiO2/GCE simultaneously and incubated for 2 h at 37 °C.”), wherein the mucin molecule is coupled to a surface of the device and is configured to be in contact with mucus layer contents (Scheme 1 on page 128; section 2.7. Fabrication of the ECL aptasensor on page 128); at least one probe coupled to an end of the mucin molecule opposite to the surface of the device (Ag-ABEI@V2O5 of Scheme 1); and a detector configured to detect a presence of the probe and/or a property of the probe in order to detect a status of the mucin molecule (section 2.2. Apparatus on page 127).
Regarding claim 2, the mucin molecule comprises engineered human TR-O glycodomains or mucin-like domains decorated with O-glycans (Mucin-1 (MUC1)).
Regarding claim 3, the mucin molecule is capable of being digested by the enzyme of the first type produced by commensal microbes that reside in the mucus layer.
Regarding claim 4, the probe is an optical probe and the detector is configured to detect an optical signal (the detector detects electrochemiluminescence; electrochemiluminescence is a process that produces an emitted light).
Regarding claim 12, the sections of Yang et al. cited above disclose a method comprising the steps recited in the claim. Yang et al. specifically teaches coupling the at least one mucin molecule to the surface of the device such that the mucin molecule is in contact with mucus layer contents (page 130: “However, in the presence of 100 pg mL-1 target MUC1 (curve b), the aptasensor demonstrated a strong ECL signal.”).
Claims 1-3, 5, 6, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (Sandwich-Type Electrochemical Sensor…).
Regarding claim 1, Li et al. discloses a device for detecting enzymatic activity in mucus layer, wherein the device comprises: at least one mucin molecule corresponding to an enzyme of a first type (“MUC1” of Scheme 2 of page 2205; description of Scheme 2 on page 2205: “Scheme 2 shows the fabrication process of a sandwich-type electrochemical MUC1 sensor… Successively, the target MUC1 was captured on the electrode surface due to the specific interaction between the protein and the aptamer.”), wherein the mucin molecule is coupled to a surface of the device and is configured to be (capable of being) in contact with mucus layer contents (the MUC1 layer is coupled to the MCH/Apt/Au@rGO/GCE surface shown in Scheme 2); at least one probe coupled to an end of the mucin molecule opposite to the surface of the device (“Ab/CH-Cu@J-Cu2O” on page 2205: “The antibody-labeled CH-Cu@J-Cu2O (Ab/CH-Cu@J-Cu2O) was utilized as a signal amplification probe and ultimately achieved highly sensitive detection of the MUC1 protein.); and a detector configured to detect a presence of the probe and/or a property of the probe in order to detect a status of the mucin molecule (Page 2206: 2.5. Electrochemical Measurement.; pages 2208-2209: 3.2. Biosensor Performance and Signal Amplification Properties.).
Regarding claim 2, the mucin molecule comprises engineered human TR-O glycodomains or mucin-like domains decorated with O-glycans (Mucin-1 (MUC1)).
Regarding claim 3, the mucin molecule is capable of being digested by the enzyme of the first type produced by commensal microbes that reside in the mucus layer.
Regarding claim 5, the probe is a redox probe and the detector is configured to detect an oxidation-reduction activity of the redox probe (pages 2208-2209: 3.2. Biosensor Performance and Signal Amplification Properties.).
Regarding claim 6, the device further comprises a linker molecule configured to couple the mucin molecule to the surface of the device, wherein the linker molecule is inert to the mucus layer contents and other gastrointestinal tract contents (Scheme 2: MCH -- MCH is a spacer molecule that is inert to mucus layer contents and other GI tract contents).
Regarding claim 12, the sections of Li et al. cited above disclose a method comprising the steps recited in the claim. Li et al. specifically teaches coupling the at least one mucin molecule to the surface of the device such that the mucin molecule is in contact with mucus layer contents (page 2210: section 3.4. Performance of the MUC1 Electrochemical Sensor.).
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.
Claims 7-11 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al., as applied to claims 1 and 12.
Regarding claims 7 and 13, Yang et al. discloses all of the elements of the current invention, as discussed in paragraph 5 above, except for the device comprising at least one further mucin molecule corresponding to an enzyme of a second type, wherein the at least one further mucin molecule is coupled to the surface of the device and is configured to be in contact with the mucus layer contents; and at least one further probe coupled to an end of the at least one further mucin molecule opposite to the surface of the device; wherein the detector is configured to detect a presence of the further probe and/or a property of the further probe in order to detect a status of the at least one further mucin molecule. It is noted that the claim is merely directed to a duplication of parts. According to MPEP section 2144.04 VI. B., the court has held that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced. As the specification is silent with regard to any criticality or unexpected results related to the claimed duplication of parts, the inclusion of a second mucin molecule and a second probe is merely a matter of obvious design choice.
Regarding claim 8, the at least one further mucin molecule is capable of being digested by the enzyme of the second type produced by commensal microbes that reside in the mucus layer.
Regarding claims 9 and 14, one of ordinary skill in the art would have realized that the detector of Yang et al. would detect the presence/property of the probe and the presence/property of the at least one further probe either simultaneously or sequentially (as these are the only two options). As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have configured the detector of Yang et al. such that it detects the presence/property of the probe and the presence/property of the at least one further probe either simultaneously or sequentially, as it would merely be choosing from a finite number of identified, predictable solutions (detecting simultaneously or detecting sequentially), with a reasonable expectation of success.
Regarding claim 10, the mucin molecule and the at least one further mucin molecule would inherently be coupled to the surface of the device at predefined locations.
Regarding claims 11 and 15, the device of Yang et al. is capable of detecting enzymatic degradation and/or removal of the mucin molecule or the at least one further mucin molecule.
Claims 7-11 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al., as applied to claims 1 and 12.
Regarding claims 7 and 13, Li et al. discloses all of the elements of the current invention, as discussed in paragraph 6 above, except for the device comprising at least one further mucin molecule corresponding to an enzyme of a second type, wherein the at least one further mucin molecule is coupled to the surface of the device and is configured to be in contact with the mucus layer contents; and at least one further probe coupled to an end of the at least one further mucin molecule opposite to the surface of the device; wherein the detector is configured to detect a presence of the further probe and/or a property of the further probe in order to detect a status of the at least one further mucin molecule. It is noted that the claim is merely directed to a duplication of parts. According to MPEP section 2144.04 VI. B., the court has held that the mere duplication of parts has no patentable significance unless a new and unexpected result is produced. As the specification is silent with regard to any criticality or unexpected results related to the claimed duplication of parts, the inclusion of a second mucin molecule and a second probe is merely a matter of obvious design choice.
Regarding claim 8, the at least one further mucin molecule is capable of being digested by the enzyme of the second type produced by commensal microbes that reside in the mucus layer.
Regarding claims 9 and 14, one of ordinary skill in the art would have realized that the detector of Li et al. would detect the presence/property of the probe and the presence/property of the at least one further probe either simultaneously or sequentially (as these are the only two options). As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have configured the detector of Li et al. such that it detects the presence/property of the probe and the presence/property of the at least one further probe either simultaneously or sequentially, as it would merely be choosing from a finite number of identified, predictable solutions (detecting simultaneously or detecting sequentially), with a reasonable expectation of success.
Regarding claim 10, the mucin molecule and the at least one further mucin molecule would inherently be coupled to the surface of the device at predefined locations.
Regarding claims 11 and 15, the device of Li et al. is capable of detecting enzymatic degradation and/or removal of the mucin molecule or the at least one further mucin molecule.
Claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. in view of Zhu et al. (A Packaged Multiplexed Fluorescent… – cited by Applicant).
Regarding claim 16, Yang et al. discloses all of the elements of the current invention, as discussed in paragraph 5 above, except for the device comprising a transmitter configured to receive the signal from the probe and transmit the signal to an external device (it is noted that the “10 µL of 2.5 µM H1” of Scheme 1 is a linker that couples the mucin molecule to the device). Zhu et al. teaches a packaged bio-molecular sensor array including a detector configured to detect a signal from a probe, and a transmitter configured to receive the signal from the probe and transmit the signal to an external device for analysis (see ABSTRACT, third full paragraph of I. INTRODUCTION section on page 1, and Figure 1 on page 2). Section II. A. Sensing Targets and Bio-markers teaches that sensing target molecules within the human GI tract by using the disclosed encapsulated sensor in-vivo can yield significant impact to existing bio-molecular diagnostic methods. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Yang et al. such that it is incorporated into an encapsulated, ingestible bio-sensor, such as the one taught by Zhu et al., as this would allow real-time, in-vivo monitoring of target molecules within the human GI tract. The incorporation of a transmitter would allow the signals detected by the detector to be transmitted to an external device for further processing and analysis.
Regarding claim 17, the mucin molecule comprises engineered human TR-O glycodomains or mucin-like domains decorated with O-glycans (Mucin-1 (MUC1)).
Regarding claim 18, the mucin molecule is capable of being digested by a glycosidase, a sulphatase, and/or a sialidase within the mucus layer.
Regarding claim 19, the probe is a fluorescent probe and the detector is a fluorescence detector (the detector of Yang et al. detects electrochemiluminescence; electrochemiluminescence is a process that produces an emitted light; Official notice is being taken that it is well known in the art to use a fluorescent probe to detect electrochemiluminesence).
Claims 16-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. in view of Zhu et al.
Regarding claim 16, Li et al. discloses all of the elements of the current invention, as discussed in paragraph 6 above, except for the device comprising a transmitter configured to receive the signal from the probe and transmit the signal to an external device. Zhu et al. teaches a packaged bio-molecular sensor array including a detector configured to detect a signal from a probe, and a transmitter configured to receive the signal from the probe and transmit the signal to an external device for analysis (see ABSTRACT, third full paragraph of I. INTRODUCTION section on page 1, and Figure 1 on page 2). Section II. A. Sensing Targets and Bio-markers teaches that sensing target molecules within the human GI tract by using the disclosed encapsulated sensor in-vivo can yield significant impact to existing bio-molecular diagnostic methods. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Li et al. such that it is incorporated into an encapsulated, ingestible bio-sensor, such as the one taught by Zhu et al., as this would allow real-time, in-vivo monitoring of target molecules within the human GI tract. The incorporation of a transmitter would allow the signals detected by the detector to be transmitted to an external device for further processing and analysis.
Regarding claim 17, the mucin molecule comprises engineered human TR-O glycodomains or mucin-like domains decorated with O-glycans (Mucin-1 (MUC1)).
Regarding claim 18, the mucin molecule is capable of being digested by a glycosidase, a sulphatase, and/or a sialidase within the mucus layer.
Regarding claim 20, the probe is a redox probe and the detector is configured to detect an oxidation-reduction potential of the probe (pages 2208-2209 of Li et al.: 3.2. Biosensor Performance and Signal Amplification Properties.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
References cited in the attached PTO-892 generally disclose a device and method for detecting enzymatic activity in a mucus layer using at least one mucin molecule and a probe/detector.
Hosu et al. (Mucin 4 detection…) teaches using a linker molecule to couple a mucin molecule to a device.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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