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 without traverse of species HE4 in the reply filed on 04/28/2025 is acknowledged. Claim 7 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/28/2025. Claims 1-6 and 8-10 are amended, claims 52-55 are new. Claims 1-6, 8-10, and 52-55 are examined below.
Priority
The present application, filed 08/04/2021, is a divisional of 16/099,662, filed 11/07/2018, which is a proper National Stage (371) entry of PCT/US2017/026563, filed 04/07/2017 which claims benefit under 35 U.S.C. 119(e) to provisional application No. 62/334,412, filed 05/10/2016.
Information Disclosure Statement
The information disclosure statement (IDS) filed 08/04/2021, has been considered, initialed and is attached hereto.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levine, DA US20130078319A1.
Regarding claim 1, Levine teaches a biosensing device (sensor) that is implantable into various body cavities and may include a microfluidics concentrator chamber and a transducer layer where proteins are detected, and a transceiver layer (Levine, page 5, paragraph [0072], lines 5-11). Levine further teaches that the transducer can be functionalized by association of one or more antibodies (analyte-binding species) and separation activates carbon nanotubes to create a signal detected by the receiver layer (Levine, page 5, see entire paragraph [0073]). Levine further teaches that antibodies will be coupled to a dendrimer backbone (polymer) and the construct will then be applied to single or multi-walled carbon nanotubes (polymer associated with single wall carbon nanotubes; Levine, page 6, see entire paragraph [0090]). Levine teaches technologies for detecting and/or characterizing cancer, and in particular ovarian cancer (Levine, page 1, paragraph 3, lines 1-7). Levine further teaches that the majority of ovarian carcinoma likely develops within the fallopian tube which lies in direct continuity with the endometrial/uterine cavity, which can serve as a proximal anatomic site for the detection of tissue specific biomarkers and further that nanotechnology creates the opportunity to change the entire paradigm of ovarian cancer screening using long-term monitoring devices within appropriate body cavities (Levine, page 4, paragraph [0067], lines 7-15).
The preamble of claim 1 recites “an intrauterine device”; Levine fails to explicitly state that the sensor is an intrauterine device.
However, Levine teaches a biosensing device comprising single-walled carbon nanotubes, a polymer and an analyte-binding species that is implantable into various body cavities.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art is capable of performing the intended use, then it meets the claims. In the instant claim, the device of Levine is a biosensing device that is implantable into various body cavities and therefore is structurally usable as an intrauterine device. Therefore, because the device of Levine is structurally indistinguishable from that presently claimed, it would be expected that it would be capable of being used as claimed, namely as an “intrauterine device”. Because the prior art device would be capable of performing the recited intended use, the reference meets the claim.
Regarding claims 2 and 3, Levine teaches that the transducer can be functionalized by association of one or more antibodies (protein (claim 2); antibody (claim 3); Levine, page 5, paragraph [0073], lines 1-5).
The preamble of claims 2 and 3 recite “an intrauterine device”; Levine fails to explicitly state that the sensor is an intrauterine device.
However, Levine teaches a biosensing device comprising single-walled carbon nanotubes, a polymer and an analyte-binding species that is implantable into various body cavities.
A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art is capable of performing the intended use, then it meets the claims. In the instant claim, the device of Levine is a biosensing device that is implantable into various body cavities and therefore is structurally usable as an intrauterine device. Therefore, because the device of Levine is structurally indistinguishable from that presently claimed, it would be expected that it would be capable of being used as claimed, namely as an “intrauterine device”. Because the prior art device would be capable of performing the recited intended use, the reference meets the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Although the recitation of an “intrauterine device” in claims 1-3 is a recitation of intended use of the claimed invention and does not result in a structural difference between the claimed invention and the prior art (and so Levine is considered to anticipate the claims, as indicated above), in the interest of compact prosecution, the following additional rejection is also made.
Claims 1-3 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Levine, DA US20130078319A1.
Regarding claim 1, Levine teaches a biosensing device (sensor) that is implantable into various body cavities and may include a microfluidics concentrator chamber and a transducer layer where proteins are detected, and a transceiver layer (Levine, page 5, paragraph [0072], lines 5-11). Levine further teaches that the transducer can be functionalized by association of one or more antibodies (analyte-binding species) and separation activates carbon nanotubes to create a signal detected by the receiver layer (Levine, page 5, see entire paragraph [0073]). Levine further teaches that antibodies will be coupled to a dendrimer backbone (polymer) and the construct will then be applied to single or multi-walled carbon nanotubes (polymer associated with single wall carbon nanotubes; Levine, page 6, see entire paragraph [0090]). Levine teaches technologies for detecting and/or characterizing cancer, and in particular ovarian cancer (Levine, page 1, paragraph 3, lines 1-7). Levine further teaches that the majority of ovarian carcinoma likely develops within the fallopian tube which lies in direct continuity with the endometrial/uterine cavity, which can serve as a proximal anatomic site for the detection of tissue specific biomarkers and further that nanotechnology creates the opportunity to change the entire paradigm of ovarian cancer screening using long-term monitoring devices within appropriate body cavities (Levine, page 4, paragraph [0067], lines 7-15).
Levine fails to explicitly state that the sensor is an intrauterine device. However, Levine teaches a biosensing device that is implantable into various body cavities and further teaches technologies to characterize ovarian cancer. Still further, Levine teaches that the uterine cavity can serve as a proximal anatomic site for the detection of tissue specific biomarkers and nanotechnology creates the opportunity to use long-term monitoring devices within appropriate body cavities.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that the biosensor of Levine be capable of use as a biosensor to be implanted in the uterine cavity, i.e. to have provided the device as an intrauterine device, because of the teaching of Levine that the biosensor can be implanted in various body cavities and that the uterine cavity can serve as a proximal anatomic site for the detection of tissue specific biomarkers to characterize ovarian cancer, one having ordinary skill specifically motivated to provide the device as an intrauterine device in order to detect/characterize biomarkers related to ovarian cancer, as suggested by Levine.
One having ordinary skill in the art would have a reasonable expectation of success because Levine teaches that the biosensing device is implantable into various body cavities and that nanotechnology creates the opportunity to use long-term monitoring devices within appropriate body cavities.
Regarding claims 2 and 3, Levine teaches that the transducer can be functionalized by association of one or more antibodies (protein (claim 2); antibody (claim 3);Levine, page 5, paragraph [0073], lines 1-5).
Regarding claim 54, Levine teaches an implantable device including a microfluidics concentrator chamber, a transducer layer (sensor), and a transceiver layer wherein body fluids pass through the microfluidics concentrator chamber and proteins are detected on the transducer layer (Levine, page 6, see entire paragraph [0092] and Figure 4, Sheet 5 of 6). Levine further teaches that the transducer (sensor) can be functionalized by association of one or more antibodies (Levine, page 5, see entire paragraph [0073]) and that antibodies will be coupled to a dendrimer backbone (polymer) and the construct will then be applied to single or multi-walled carbon nanotubes (Levine, page 6, see entire paragraph [0090]).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that in the implantable device of Levine, the biosensor would necessarily be immobilized on the microfluidics concentrator chamber (solid support) in order to function as a multi-modular device (transducer, transceiver, and concentrator) when implanted in a body cavity.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Levine DA in view of Han et al. Multifunctional dendrimer‐templated antibody presentation on biosensor surfaces for improved biomarker detection. Advanced functional materials. 2010 Feb 8;20(3):409-21.
Regarding claim 4, Levine teaches an intrauterine sensor comprising a single walled carbon nanotube, a polymer and an analyte-binding species substantially as claimed.
Levine further teaches that antibodies will be coupled to a dendrimer (polymer) and the construct will then be applied to single or multi-walled carbon nanotubes (Levine, page 6, see entire paragraph [0090]).
Levine fails to teach that the analyte binding species is attached to the polymer via a functional group.
Han teaches synthesizing a bifunctional hydroxyl/thiol—functionalized G4-polyamidoamine dendrimer and converting part of the dendrimer thiol groups to hydrazide functionalities (functional group). Han further teaches coupling the resulting dendrimer-modified surface to capture antibody (analyte binding species) in the Fc region of the oxidized antibody which preserves the orientation flexibility of the antigen binding region of the antibody (Han, page 409, ‘Abstract’, lines 6-13). Han further teaches that the sensitivity of an immunosensor can be increased by control of the orientation of antibodies immobilized on the sensor surface and that therefore an immobilization technique which provides favorable antigen binding orientation is highly desirable (Han, page 413, ‘2.3.’, see entire first paragraph).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor of Levine by attaching the analyte binding species via a functional group because of the teaching of Han that this preserves the orientation flexibility of the antigen binding region of the antibody. One having ordinary skill in the art would be motivated to do so because of the teaching of Han by controlling the orientation of antibodies immobilized on the sensor surface can increase the sensitivity of an immunosensor.
One having ordinary skill in the art would have a reasonable expectation of success modifying the sensor of Levine by attaching the binding species via a functional group because both Levine and Han teach a sensor comprising a dendrimer functionalized with antibodies.
Claims 5-6 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Levine in view of Zheng, US20070275396A1.
Regarding claim 5, Levine teaches an intrauterine device comprising a single walled carbon nanotube, a polymer and an analyte species substantially as claimed.
Levine teaches that proteins are detected on the transducer layer and when appropriate molecules are generated a signal is created (Levine, page 5, paragraph [0072], lines 11-13). Levine further teaches that activated carbon nanotubes create an electric signal detected by the transceiver layer (Levine, page 5, paragraph [0073], lines 7-8), and a transceiver layer that transmits the signal to activate a remote sensor (Levine, page 5, paragraph [0072], lines 11-13).
Levine does not teach that binding of the desired analyte to the analyte-binding species results in a detectable change in intrinsic fluorescence of the single walled carbon nanotube.
However, the limitations of claim 5 are directed to the intended use of the claimed device, namely the use of the device in order to bind and detect a “desired analyte” with the “analyte-binding species” of the device to result in a detectable change in intrinsic fluorescence of the single walled carbon nanotube. The limitation “whereupon binding of the desired analyte to the analyte-binding species results in a detectable change in intrinsic fluorescence of the SWCNT”, it does not appear that the recited functional language imparts any specific additional structural feature to the IUD of the claimed invention.
Zheng teaches a nanotube-nucleic acid complex, the complex comprising singly dispersed carbon nanotubes and an associated nucleic acid (Zheng, ‘Abstract’, lines 1-6). Zheng further teaches that either one or both of the target nucleic acid molecule or the dispersant nucleic acid molecule is functionalized with a member of a binding pair and were the member of a binding pair is selected from a group comprising antigen/antibody, biotin/avidin, folic acid/folate, hormone/hormone receptor and others (analyte binding species) allowing for capture of analytes that may be desirable to detect (sensor; Zheng, pages 10-11, see claims 9 and 10). Zheng teaches that detection of the target is accomplished indirectly via measuring the change in properties of the carbon nanotube-nucleic acid complex and that detection therefore consists of measuring the conductive, spectral or electrical properties of the carbon nanotube in the complex (Zheng, page 3, see entire paragraph [0051]). Zheng further teaches that carbon nanotubes will demonstrate measurable changes in surface charge in response to hybridization and similarly electrical conductivity has been correlated with surface changes. Alternatively, it has been shown that the native fluorescence of single walled carbon nanotubes will undergo a shift in response to changes in the charge of an associated nucleic acid. Zheng teaches that any of the above methods may be used as a detection means to report on the hybridization event (Zheng, page 7, see entire paragraph [0108]). Zheng further teaches that prior to contacting the complex with the target a fluorescence spectrum may be obtained from the complex (intrinsic fluorescence). The spectrum is obtained again after the complex is contacted with the target and those complexes showing a spectral shift (detectable change) will be reporting a hybridization event and the identification of the target (desired analyte) in the sample (Zheng, page 7, paragraph [0111], lines 17-22). Zheng further teaches that the carbon nanotube allows for sensitive detection of the hybridization event based on the ability to measure subtle differences in the properties of the carbon nanotube before and after the hybridization and that for example, small changes in spectral properties of the carbon nanotube may be correlated with hybridization (Zheng, page 6, see entire paragraph [0107]).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that the sensor of Levine be capable of use to detect a spectral shift in the intrinsic fluorescence of the nanotubes, similarly as taught by Zheng. Zheng is teaching that such a sensor used in this manner is capable of sensitive detection of the hybridization event because small changes in spectral properties of the carbon nanotube may be correlated with hybridization.
There would be no need to change the device (structurally) of Levine, one having ordinary skill in the art would expect that the device of Levine be capable of being used in intrinsic fluorescence detection of the single walled carbon nanotube because(Zheng) teaches that conductive, spectral or electrical properties may be used as a detection means to report on the hybridization event. It would be expected possible to detect (i.e., to apply the device for the intended use) electrical properties as taught by Levine with the fluorescent (spectral) detection as taught by Zheng and the result would predictably be the detection of a hybridization event. There is no structural difference between the prior art device of Levine in view of Zheng, i.e. a device comprising a microfluidics concentrator chamber, a transducer layer, and a transceiver layer, capable of detecting a hybridization event by measuring fluorescence and transmitting a signal, and the device as claimed. As such the prior art device of Levine addresses the claim.
One having ordinary skill in the art would further have a reasonable expectation of success because both Levine and Zheng teach nanotubes functionalized with antibodies and because the fluorescence is intrinsic to the nanotubes one would expect success measuring a change in fluorescence as taught by Zheng in the device of Levine.
Regarding claim 6, Levine teaches an intrauterine device comprising a single walled carbon nanotube, a polymer and an analyte species substantially as claimed.
Levine teaches measuring biomarkers (and as such analyte-binding species to bind) for patients with ovarian carcinoma comprising HE4, CA-125, mesothelin, and YKL-40 (Levine, page 4-5, see entire paragraph [0069]).
Regarding claims 9 and 10, Levine teaches an intrauterine device comprising a single walled carbon nanotube, a polymer and an analyte species substantially as claimed.
Levine fails to teach that the polymer comprises a member selected from DNA, LNA, PNA, an amino-acid sequence, and a synthetic monomer (claim 9), or, specifically, comprises DNA (claim 10).
Zheng teaches a complex comprising a single walled carbon nanotube associated with a dispersant nucleic acid molecule (Zheng, page 1, paragraph [0012], lines 3-5). Zheng further teaches that a dispersant nucleic acid molecule is a nucleic acid that is non-covalently associated with a carbon nanotube and that it generally comprises a region of complementarity with a target sequence (Zheng, page 3, paragraph [0050], lines 1-6). Put another way, Zheng teaches a nucleic acid molecule that has a certain sequence and as such Zheng teaches a polymer that is a nucleic acid. Zheng further teaches that dispersant nucleic acid molecules are single stranded and effectually disperse a population of carbon nanotubes in a solution (Zheng, page 3, paragraph [0050], lines 2-4). Zheng further teaches that the nanotube-nucleic acid complex is comprised of singly dispersed carbon nanotubes and a dispersant nucleic acid molecule associated with the carbon nanotube (Zheng, paragraph [0009], lines 3-6). Zheng further teaches that either one or both of the target nucleic acid molecule or the dispersant nucleic acid molecule is functionalized with a member of a binding pair and were the member of a binding pair is selected from a group comprising antigen/antibody, biotin/avidin, folic acid/folate, hormone/hormone receptor and others (analyte binding species) allowing for capture of analytes that may be desirable to detect (sensor; Zheng, pages 10-11, see claims 9 and 10). Zheng further teaches that the complex of a DNA-wrapped single walled nanotube allows for the facile and sensitive detection of target molecules in diagnostic regimes (Zheng, page 1, paragraph [0008], lines 1-6).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Levine comprising a dendrimer to have substituted for the dendrimer a polymer that is single stranded DNA as taught by Zheng because of the teaching of Zheng that single stranded nucleic acid molecules effectually disperse a population of carbon nanotubes in a solution resulting in singly dispersed DNA-wrapped single walled nanotubes capable of facile and sensitive detection of target molecules in diagnostic regimens.
One having ordinary skill in the art would have a reasonable expectation of success because Levine teaches an intrauterine device comprising a single walled carbon nanotube, a polymer and an analyte species attached to the polymer and Zheng teaches success with a single walled carbon nanotube device having a polymer that is a single stranded DNA molecule which is functionalized with a binding molecule.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Levine, in view of Han and Nii et al. Controlling the adsorption and desorption of double-stranded DNA on functionalized carbon nanotube surface. Colloids and Surfaces B: Biointerfaces. 2013 Jun 1;106:234-9.
Regarding claim 8, Levine and the cited art above teach an intrauterine device comprising a single walled carbon nanotube, a polymer and an analyte species substantially as claimed.
Levine fails to teach that the dendrimer is conjugated to the single-walled carbon nanotube via a linker.
Han teaches immobilizing a bifunctional hydroxyl/thiol-functionalized G4-polyamidoamine dendrimer on a polyethylene-glycol functionalized assay plate. The modified dendrimer surface is further coupled to a capture antibody. (Han, page 409, ‘Abstract’, lines 6-12). Han further teaches that the results suggest that using the hydroxyl-functionalized dendrimer and polyethylene glycol is effective in preventing nonspecific adsorption (Han, page 16, 3rd paragraph, lines 17-25). Han further teaches that the use of a long polyethylene glycol linker and dendrimer between the capture antibody and plate gives diffusional and conformational flexibility to the antibody for improved target binding (Han, page 418, 2nd column, lines 18-20).
Nii teaches controlled absorption and desorption of double-stranded DNA (polymer) on single walled carbon nanotube surface functionalized with polyethylene glycol (linker; Nii, page 234, ‘Abstract’, lines 1-2). Nii further teaches that the DNA molecules attach well to polyethylene glycol single-walled carbon nanotubes at room temperature. As such, Nii teaches conjugating a polymer, namely the DNA molecules, to a single-walled carbon nanotube via a polyethylene glycol linker. Nii further teaches confirming the stability of polyethylene glycol-single walled nanotubes after the annealing procedure and that when the method is combined with other techniques such as hybridization of DNA and protein molecules, it will be one of the key techniques to develop new DNA devices using carbon nanotubes as a substrate (Nii, page 239, ‘4. Conclusion’, see entire paragraph).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the biosensor of Levine by using polyethylene glycol as a linker to attach a dendrimer to the single-walled carbon nanotube sensor because of the teaching of Han that using a long polyethylene glycol linker to immobilize a dendrimer functionalized with antibody to a surface gives diffusional and conformational flexibility to the antibody for improved target binding.
One having ordinary skill in the art would have a reasonable expectation of success modifying the device of Levine by adding a dendrimer (a type of polymer) as taught by Levine to a single walled carbon nanotube using a polyethylene glycol linker, because Han teaches success attaching a polymer, which is a dendrimer, to a surface using a polyethylene glycol linker and Nii et al. further supports a reasonable expectation of success because Nii teaches applying a polyethylene glycol linker to successfully and stably attach polymers to single-walled carbon nanotubes (demonstrates the ability of this type of linker to attached to SWCNT). Put another way, one having ordinary skill in the art would expect success in attaching the polymer of Han to single walled carbon nanotubes using polyethylene glycol because of the success of Nii using polyethylene glycol to attach a polymer to single walled carbon nanotubes, to thereby achieve diffusional and conformation flexibility to an antibody for improved target binding.
Claims 52 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Levine as applied to claim 1 above, in view of Wildemeersch D. Intrauterine contraceptives that do not fit well contribute to early discontinuation. The European Journal of Contraception & Reproductive Health Care. 2011 Apr 1;16(2):135-41.
Regarding claims 52 and 53, Levine teaches an intrauterine device comprising a single walled carbon nanotube, a polymer and an analyte species substantially as claimed.
Levine teaches that the uterine cavity can serve as a proximal anatomic site for the detection of tissue specific biomarkers and further that nanotechnology creates the opportunity to change the entire paradigm of ovarian cancer screening using long-term monitoring devices within appropriate body cavities (Levine, page 4, paragraph [0067], lines 7-15).
Levine fails to teach the dimension of the intrauterine device and as such fails to teach that the device is 20 mm to 40 mm in width (claim 52) and in length (claim 53).
Wildemeersch teaches an intrauterine contraceptive device has a width of 23 mm and a length of 29 mm and has a better continuation rate in nulliparous women than a standard contraceptive of the same type that has a width of 32 mm and that a smaller T-shaped intrauterine device that has a shorter width of 28 mm adapts better to narrow uterine cavities (Wildemeersch, page 137, see entire 3rd paragraph). Wildemeersch further teaches that intrauterine contraceptives whose dimensions are in accordance with those of the uterine cavities that will host them may cause the least side effects and thus reduce the risk of discontinuation (Wildemeersch, page 137, see entire 4th paragraph). Wildemeersch further teaches that the intrauterine contraceptive-endometrial cavity relationship is a main determinant in the user’s acceptance of the method (Wildemeersch, page 136, ‘Container-Content Relationship’, lines 8-11). Wildemeersch further teaches that if the length of the device exceeds that of the endometrial cavity, its caudal end may protrude in the cervical canal or become impacted in the uterine wall and thus cause pain, bleeding, expulsion, infection, or even perforation (Wildemeersch, page 136, 2nd paragraph, lines 13-17).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied the size of 23 mm in width and 29 mm in length as taught by Wildemeersch to the device of Levine because of the teaching of Wildemeersch that intrauterine devices that are in accordance with those of the uterine cavities that will host them reduce the risk of discontinuation and that intrauterine devices that are too long may protrude in the cervical canal or become impacted in the uterine wall and cause pain, bleeding, and other side effects. The art taught values of 23 mm in width and 29 mm in length fall within the claimed range of 20-40 mm length and 20-40 mm width respectively and therefore meets the limitation of the claims.
One of ordinary skill would have a reasonable expectation of success applying the dimensions of intrauterine contraception devices as taught by Wildemeersch to the intrauterine biosensor as taught by Levine, because both devices are intrauterine devices designed for long term wear and Wildemeersch teaches that the relationship between the intrauterine device and the endometrial cavity is a main determinant in the user’s acceptance of the device.
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Levine in view of Juanola-Feliu et al. Design of a customized multipurpose nano-enabled implantable system for in-vivo theranostics. Sensors. 2014 Oct 16;14(10):19275-306.
Regarding claim 55, Levine teaches an intrauterine device comprising a single walled carbon nanotube, a polymer and an analyte species substantially as claimed.
Levine teaches a biosensing device (sensor) that is implantable into various body cavities and may include a microfluidics concentrator chamber and a transducer layer where proteins are detected, and a transceiver layer (Levine, page 5, paragraph [0072], lines 5-11).
Levine fails to teach that the device further comprises one or more of a biocompatible gel, microcapillary, filter, mesh, tubing, compartment/dialysis membrane, or solid support in which the sensor is immobilized.
Juanola-Feliu teaches design of a Nano-Enabled implantable system for In-Vivo Theranostics (Juanola-Feliu, page 19275, see Title). Juanola-Feliu further teaches that nanotube sensors and nanobiosensors are two types of nanosensors with potential medical applications and that a nanobiosensor or nanosensor is generally defined as a nanometer size scale measurement system comprising a probe with a sensitive biological recognition element, or bio-receptor, a physicochemical detector component and a transducer in between (Juanola-Feliu, page 19285, ‘2.2.3.’, see entire paragraph). Juanola-Feliu further teaches that bio-compatibility of the final device is a main barrier and challenge for the spread of implantable sensors and that encapsulation has to be biocompatible and have a low dielectric constant as well as being conformal and resistant. Juanola-Feliu further teaches that the implantation of synthetic medical devices generates an immediate and complex material-related inflammatory response, such as blood and tissue incompatibility and bio-fouling which is an important cause of sensor dysfunction. Juanola-Feliu further teaches that to avoid these adverse physiological effects, the implanted device must be packaged with bio-compatible materials (Juanola-Feliu, page 19284, see entire “2.2.2”). Still further, Juanola-Feliu teaches that for example polyurethane has been used extensively as an outer membrane to act as a bio-compatible interface with the surrounding host tissue (Juanola-Feliu page 19284, lines 8-9). Put another way Juanola-Feliu teaches that implantable devices such as those comprising nanotubes are immobilized in a compartment such as a polyurethane covering to avoid a material-related inflammatory response and bio-fouling.
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Levine by encapsulating it in a polyurethane compartment as taught by Juanola-Feliu because of the teaching of Juanola-Feliu that the implantation of medical devices (such as biosensors) generates an immediate and complex material-related inflammatory response, such as tissue and bio-fouling which is an important cause of sensor dysfunction. One having ordinary skill in the art would have been motivated to package the device in bio-compatible materials because it aids in avoiding these adverse physiological effects.
One having ordinary skill in the art would have a reasonable expectation of success because Levine teaches an implantable device comprising nanotubes and Juanola-Feliu teaches encapsulating implantable devices, implantable devices comprising those devices comprising nanotubes.
Communication
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/STEFANIE J. KIRWIN/Examiner, Art Unit 1677
/ELLEN J MARCSISIN/Primary Examiner, Art Unit 1677