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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/07/2026 has been entered.
Please see Response to Amendment section below.
Response to Amendment
Please note that the claims filed 04/29/2026 were found to be non-compliant as the pending claims were amended and were no longer readable on the elected invention and because they were missing the proper markings to show changes, please see the notice of informal or non-responsive continued prosecution application amendment mailed 07/02/2026. In response, claims were filed 07/10/2026. However, these claims were still found to be non-compliant and therefore supplemental amendments filed 08/07/2026 were then filed.
The claims filed 08/07/2026 have been entered and are the claims being examined.
Status of Claims
Claims 1, 4, 26, 32, 35-38 remain pending in the application.
Claim Objections
Claims 1, 4 are objected to because of the following informalities:
Claim 1 lines 4, 5, and 8 all begin with a capital “A” and should be amended to be lowercase.
Throughout claim 1, reference is made to “the piezoelectric crystal” on lines 11-12, 13-14, and 15 and “the coated piezoelectric crystal” on line 17 which are understood to be the same, and it is suggested that they be called the same thing for consistency. The piezoelectric crystal and “the coated piezoelectric crystal” being different from the reference piezoelectric crystal.
On line 14 it recites “crystal; and;” where the semicolon after “and” appears to be accidentally added and should be removed.
With regards to point vi, it is suggested that the various chemicals be separated by a comma rather than a semicolon.
Claim 4 similarly recites “the piezoelectric crystal” on lines 1-2, where due to amendments to claim 1 it is suggested that it be amended to make it clear that the piezoelectric crystal being referred to is both of the ones described in claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1, 4, 26, 32, 35-38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is directed to “A molecularly imprinted polymer (MIP) coated piezoelectric sensor for detection of volatile organic compounds (VOCs) comprising:” where bullet iii describes a reference piezoelectric crystal and bullet iv describes a sensor chamber. It is not seen in the instant specification where there is support for a MIP coated piezoelectric sensor comprising a reference piezoelectric crystal and a sensor chamber.
Page 6 lines 24-30 of the instant specification describe a molecularly imprinted polymer (MIP) coated piezoelectric sensor that comprises a polymer film or polymer nanoparticles, a piezoelectric crystal, and interdigitated electrodes. However there is no description for the MIP coated piezoelectric sensor comprising a reference sensor or sensor chamber.
Page 10 lines 4-16 of the instant specification describes a sensor array, where the sensor array comprises one or more MIP coated piezoelectric sensors comprising a polymer film or nanoparticles, a piezoelectric sensor and a reference sensor comprising a non-imprinted polymer film or nanoparticles or a non-polymer film on a piezoelectric sensor and interdigitated electrodes.
Page 12 lines 4-21 of the instant specification describes a device that comprises a sensor chamber that comprises a sensor array.
Because the instant specification describes what each of a sensor, a sensor array, and a device each comprises, the claim being directed to a sensor comprising a reference sensor and sensor chamber is not supported as these components are not described to be part of a sensor.
Claims 4, 26, 32, 35-38 are rejected by virtue of being dependent on a rejected claim.
Claim 36 recites “wherein the sensor chamber is removable and configured to mate with the tubing and an electric port.” where it is not seen in the instant specification where there is support for the sensor chamber mating with an electric port.
An “electric port” is not seen anywhere in the instant specification.
While page 17 lines 9-11 describes where Figure 3 has “Dashed lines specify electrical connections and double lines with arrow heads indicate flow-path.” where it is seen in Figure 3 that there is a dashed line connecting sensor chamber 104 and control unit 108, it is unclear if this would be an “electric port”. It is not seen in the instant specification where the electrical connections would include an electric port or if the electrical connections are achieved in another way.
While an electric port is understood to be an electrical connection, not all electrical connections are electric ports.
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, 4, 26, 32, 35-38 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.
Claim 1 recites “A reference piezoelectric crystal that is non-coated with a non-imprinted polymer;” where it is unclear because if the piezoelectric is non-coated, is the non-imprinted polymer not a coating? If the non-imprinted polymer is a coating, how can something be non-coated and coated at the same time?
Page 10 lines 18-20 describes a plurality of reference sensors that “will either be a polymer coated, non-coated or both” where this is understood to mean that either all the reference sensors are either coated, all the reference sensors are non-coated, or there is a combination of both coated and non-coated reference sensors, and page 16 lines 19-20 recites “The reference sensors are non-coated or coated with non-imprinted polymer.”
Therefore, for examination it will be interpreted that the reference sensor is either non-coated or coated with a non-imprinted polymer.
Line 10 recites “the concentrated sample” where there is insufficient antecedent basis for this limitation as no concentrated sample has been recited prior. It is unclear what concentrated sample is being referred to.
Claims 4, 26, 32, 35-38 are rejected by virtue of being dependent on a rejected claim.
Claim 35 recites “the air inlet tubing” on lines 2-3 where there is insufficient antecedent basis for this limitation as no air inlet tubing has been recited prior. It is therefore unclear what air inlet tubing is being referred to.
Claim 36 recites “the tubing” where there is insufficient antecedent basis for this limitation, as no tubing has been recited prior. Therefore it is unclear what tubing is being referred to.
For examination, because claim 35 recites “air inlet tubing” it will be interpreted that claim 36 is dependent on claim 35.
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.
Claim(s) 1, 4, 26, 35, 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US-2010/0137733-A1) in view of Feng “The Fabrication and Characterization of a Formaldehyde Odor Sensor using Molecularly Imprinted Polymers”, Dickert “QCM and SAW Transducers Allow Analyte Detection from nanometer to micrometer dimensions using imprinting techniques”, and Cai (US-2017/0227508-A1).
Regarding claim 1, Wang teaches a coated piezoelectric sensor for detection of volatile organic compounds (VOCs) comprising:
(iv) a sensor chamber connected to receive the concentrated sample from a preconcentrator and defines a sample path ([0046] see exhaled breath 130 enters apparatus, optionally there can be a preconcentrator for the exhaled breath 133, Figure 1 which shows exhaled breath 130 entering the apparatus, which is a sensor chamber);
[0051] of Wang describes that breath of the subject contains markers or biomarkers suitable for detection, where the biomarker detected is a volatile organic compound (VOC) and the VOC is selected from toluene.
[0081] of Wang describes that the detector array (see Figure 1A depicting detector array 150) can be a quartz crystal microbalance and [0082] describes that each sensor includes a surface with a coating that will have an affinity for one or more of the particular chemicals being detected where the interaction between the coating and chemical in turn changes a physical property of the sensor such as resonant frequency and that the changed physical property can be measured using a transducer or other measurement device. However, Wang does not specify the particular components when the sensor is a quartz crystal microbalance nor the type of coating and therefore does not teach:
(i) A piezoelectric crystal;
(ii) a polymer film or polymer nanoparticles directly formed on the piezoelectric crystal, the polymer being molecularly imprinted with a VOC target molecule;
(iii) a reference piezoelectric crystal that is non-coated with a non-imprinted polymer;
(v) wherein the frequency of the piezoelectric crystal changes upon binding of the VOC target molecule to the molecularly imprinted polymer;
In the same problem solving area of detecting volatile and deleterious compounds, Feng teaches a quartz crystal microbalance and molecularly imprinted polymers (Feng; abstract, page 378 column 1 paragraphs 1-2).
Specifically, Feng teaches
(i) A piezoelectric crystal (page 378 column 1 paragraph 2 into column 2 see quartz crystal microbalance (QCM) is a tiny mass detection technique and the response of the device is based on the decrease in resonant frequency of the crystal as the mass of the device increases);
(ii) A polymer film directly formed on the piezoelectric crystal, the polymer being molecularly imprinted with a VOC target molecule (page 378 column 1 paragraph 1 see formaldehyde is a volatile and deleterious compound, page 379 column 2 paragraph 1 see MIPs preparation section where the result is one QCM with a MIP (the template to make the MIP being formaldehyde), additionally see the solution is dropped onto one side of the QCM and is then polymerized);
(iii) A reference piezoelectric crystal that is non-coated with a non-imprinted polymer (page 379 column 2 paragraph 1 see non-imprinted polymers were synthesized under the same condition without a template, see page 381 Figure 4 where the graph shows the frequency shift on the y axis and concentration on the x axis where there are measurements for both the imprinted sensor and non-imprinted sensor);
Wang is silent with regards to specific structure of a quartz crystal microbalance for sensing VOCs, therefore, it would have been necessary and thus obvious to look to the prior art for conventional QCMs that sense VOCs. Feng provides this conventional teaching showing that it is known in the art to use QCMs that have imprinted and non-imprinted polymer coatings. Therefore, it would have been obvious to one having ordinary skill in the art to make the detector array of Wang be QCMs that have imprinted and non-imprinted polymer coatings because it is taught by Feng that they are effective for measuring the concentration of an analyte.
One skilled in the art would find it obvious that because toluene is a desired VOC to be detected in Wang, the template for the MIP will be toluene.
[0046] of Wang describes that signals from the detector array module produces a signal indicative of various biomarkers and the signal is analyzed, where [0084]-[0057] describe where the signal analysis is done via a neural network algorithm or learning algorithm but does not describe taking into account reference and sensor signals. Page 381 column 1 paragraph 1 of Feng that a linear relationship between the concentration of formaldehyde and frequency shifts can be obtained, where Figure 4b on page 381 shows a graph of frequency shifts along the y axis and concentration on the x axis for the imprinted sensor, non-imprinted sensor, and linear fitting. However, it does not appear that the equation takes into account the difference between the MIP sensor and the non-imprinted sensor. Therefore Wang nor Feng teach:
(v) the change in frequency of the coated piezoelectric crystal is compared to the frequency of the reference piezoelectric crystal to determine a concentration of the VOC target molecule;
In the analogous art of quartz crystal microbalances that are transferred into chemical sensors through the use of molecularly imprinted polymers, Dickert teaches a dual electrode QCM with a reference electrode (coated with non-imprinted polymer) and sensitive electrode (honeycomb-like imprints) where the differential measurement can be performed with a mixer which allows for the unspecific adsorption phenomena to be eliminated during QCM measurements, where Dickert describes that the frequency of vibrations corresponds to mass loading (Dickert; page 528 column 1 paragraph 3, page 528 column 2 paragraph 1, page 529 column 2 paragraph 2, page 533 column 1 paragraph 3).
It would have been obvious to one skilled in the art to modify the analysis of the signals of exhaled breath from the imprinted and non-imprinted QCMs of modified Wang such that it takes into account the frequency changes of the non-imprinted QCM because it is taught by Dickert that a differential measurement eliminates unspecific adsorption phenomena during QCM measurements (Dickert; page 529 column 2 paragraph 2).
Figure 1A of Wang shows exhaled breath 130 entering the apparatus, however Wang does not teach that the sensor chamber positions the piezoelectric crystal and the reference piezoelectric crystal such that an airstream flows substantially perpendicular to the coated surface of the piezoelectric crystal.
In the analogous art of breath sensor apparatuses for detecting the presence of a compound in exhaled gas, Cai teaches where the plane of a sensor is substantially perpendicular relative to the general airflow passing from a gas inlet (Cai; abstract, [0057]).
It would have been obvious to one skilled in the art to modify the apparatus of Wang such that the exhaled breath flows substantially perpendicular to the QCMs because it is taught by Cai that it is effective and desirable for airflow from a breath sample to be perpendicular to a sensor (Cai; [0057]).
Regarding claim 4, modified Wang teaches the sensor according to claim 1. Wang further teaches wherein the piezoelectric crystal is a quartz crystal microbalance (QCM) sensor (Wang; [0081]).
Wang has been modified with Feng such that the QCM sensor is more specifically a imprinted QCM and a non-imprinted QCM.
Regarding claim 26, modified Wang teaches the sensor of claim 1. Feng further teaches wherein the polymer film comprise at least one monomer and a crosslinker (Feng; page 379 column 2 paragraph 1 see methacrylic acid, MAA the functional monomer, and ethylene glycol dimethacrylate, EGDMA the crosslinker).
Regarding claim 35, modified Wang teaches the sensor of claim 1. Wang further teaches wherein the sensor chamber comprises an air inlet from the preconcentrator (Wang; [0046] see Figure 1A where exhaled breath 130 enters the apparatus where optionally there can be a preconcentrator for the exhaled breath. The apparatus will therefore need to have an air inlet to allow exhaled breath to enter).
Wang has been modified with Cai such that the exhaled breath airflow will be perpendicular to the detector array, therefore the air inlet will be directed at the detector array so that exhaled breath flow is substantially perpendicular. [0060] of Wang describes where subjects can use the apparatus by breathing in and out through a disposable mouthpiece. The disposable mouthpiece is an air inlet tubing that will be connected to the apparatus and will be directed at the detector array.
Additionally, Wang has been modified with Feng such that it includes an imprinted and non-imprinted QCM sensors.
However, it is not seen in Figure 1A of Wang that the apparatus has an air outlet.
Cai teaches where the chamber for retaining a gas sample 10 includes both a gas inlet 11 for introducing a gas sample and gas outlet 13 (Cai; [0056], [0057], Figure 1A).
It would have been obvious to one skilled in the art to modify the apparatus of Wang such that it includes a gas outlet because it is taught by Cai that it is desirable to have a gas outlet for a chamber that receives a gas sample to be detected as it allows gas to flow from the chamber when pressure is applied to the gas inlet (Cai; [0051]).
Please note that the preconcentrator has not been positively recited, and is therefore not a part of the claimed sensor.
Regarding claim 38, modified Wang teaches the sensor of claim 1. Feng further teaches wherein each of the sensors are connected to a frequency counter that calculates the frequency of each of these sensors in real time (Feng; page 379 column 2 paragraph 2 see to obtain precise and real-time data we developed a circuit based on a singleschip technique and the results were calibrated via a standard frequency counter, the frequency shifts of QCM could be monitored uninterruptedly by the circuit, additionally see Figure 1 which shows a frequency collection component, an oscillator and +5V power supply).
Wang is silent with regards to specific transducer or other measurement device that measures the change in the physical property, therefore, it would have been necessary and thus obvious to look to the prior art for conventional transducers/measurement devices. Feng provides this conventional teaching showing that it is known in the art to use an oscillator and frequency counter. Therefore, it would have been obvious to one having ordinary skill in the art to make the transducer/measurement device Wang be the oscillator and frequency counter of Feng because Feng teaches that these components are effective for monitoring frequency shifts.
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US-2010/0137733-A1), Feng “The Fabrication and Characterization of a Formaldehyde Odor Sensor using Molecularly Imprinted Polymers”, Dickert “QCM and SAW Transducers Allow Analyte Detection from nanometer to micrometer dimensions using imprinting techniques”, and Cai (US-2017/0227508-A1), and in further view of Markowitz (US-2003/0191205-A1).
Regarding claim 32, modified Wang teaches the sensor of claim 1. Wang has been modified such that the QCM sensors with a coating described in [0081]-[0082] are more specifically imprinted and non-imprinted MIP QCM sensors as taught by Feng. Wang nor Feng teach wherein said polymer nanoparticles have a particle size ranging from 100 to 500 nm.
In the analogous art of molecularly-imprinted materials, Markowitz teaches a molecularly imprinted material and molecularly imprinted particles (Markowitz; [0002], [0019], [0021]).
Specifically, Markowitz teaches where a molecularly imprinted material has a solid structure that has pores, channels or other voids that correspond to the shape of the supramolecular structure, where alternatively molecularly imprinted particles may be formed where the imprinted particles have a size of between 50 and about 1200 nm (Markowitz; [0019], [0021]).
Examiner finds that the prior art contained a device/method/product (i.e., QCM sensors) which differed from the claimed device by the substitution of component(s) (i.e., the MIP being a film) with other component(s) (i.e., polymer nanoparticles), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan could have substituted one known element with another (i.e., the film for nanoparticles), and the results of the substitution (i.e., sensing a target analyte) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to substitute the MIP film of reference modified Feng with molecularly imprinted nanoparticles of reference Markowitz, since the result would have been predictable.
The claimed range overlaps or falls within the prior art range; in cases where the claimed range overlaps or falls within the prior art range, a prima facie case of obviousness of the range exists. It would have been obvious to one having ordinary skill in the art to have selected the portion of the particle size in the range that corresponds to the claimed range. See MPEP 2144.05(I).
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US-2010/0137733-A1), Feng “The Fabrication and Characterization of a Formaldehyde Odor Sensor using Molecularly Imprinted Polymers”, Dickert “QCM and SAW Transducers Allow Analyte Detection from nanometer to micrometer dimensions using imprinting techniques”, and Cai (US-2017/0227508-A1), and in further view of White (US-2004/0101851-A1).
Regarding claim 36, modified Wang teaches the sensor of claim 1. Wang further teaches wherein the sensor chamber is removable and configured to mate with the tubing.
As seen in Figure 1A of Wang and described in [0046] the exhaled breath 130 enters the apparatus. [0060] of Wang describes where subjects can use the apparatus by breathing in and out through a disposable mouthpiece. The disposable mouthpiece is a tubing that will mate with the apparatus seen in Figure 1A.
[0046] of Wang describes that the detector array module 150 produces a signal indicative of various biomarkers where the signal is analyzed, [0082] describes where interaction between coating and chemical changes a physical property and the changed physical property of the sensor can be measured using a transducer/other measurement device, and [0084] describes that signal analysis is via a neural network algorithm or learning algorithm. However, Wang does not specify that the apparatus is configured to mate with an electric port.
In the same problem solving area of identifying a volatile compound by measuring a spatio-temporal response pattern and recognizing patterns via neural networks, White teaches where an electrical voltage signal is amplified, manipulated, and transported via electrical circuits to an analog-digital converter and a software controlled microprocessor for data manipulation, analysis, feedback control, detection, and identification (White; [0028], [0058]).
Specifically, Figure 1 of White provides an overview of analyte sensing and detection where analytes are transported to a sensor array where the analytes interact with an array of sensor elements, the sensor elements in the presence of the analytes produce a detectable response, and the spatio-temporal response is detected, recorded, manipulated, and matched to known analytes via a neural network (White; [0059]). [0144] of White further describes that neural networks may be implemented either in conventional digital CPUs, in neuronal network simulator chips, or in analogue neuronal network computers.
It would have been obvious to one skilled in the art to modify the apparatus of Wang such that the apparatus is connected to the neural network via electrical circuits because it is taught by White that electrical circuits are effective for connecting a sensor array to conventional digital CPUs, neuronal network simulator chips, or analogue neuronal network computers that implement neural networks (White; [0058], [0144]).
One skilled in the art would find it obvious that the connection points for the electrical circuits will be electrical ports.
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US-2010/0137733-A1), Feng “The Fabrication and Characterization of a Formaldehyde Odor Sensor using Molecularly Imprinted Polymers”, Dickert “QCM and SAW Transducers Allow Analyte Detection from nanometer to micrometer dimensions using imprinting techniques”, and Cai (US-2017/0227508-A1), and as evidenced by Fiorini-Debuisschert (US-2007/0148696-A1) herein Fiorini.
Regarding claim 37, modified Wang teaches the sensor of claim 1.
The limitations of claim 37 are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Wang and the apparatus of modified Wang is capable of being reused by passing a heated airstream through the sensor chamber to desorb bound VOCs. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Wang (see MPEP §2114).
It is evidenced by Fiorini that an inert gas optionally accompanied by a heating means generates a stream that desorbs a molecularly imprinted material (Fiorini; [0056]).
Response to Arguments
Applicant’s arguments filed 08/07/2026 have been fully considered. Due to amendments filed 08/07/2026, the rejections set forth in the Office Action dated 12/29/2025 are withdrawn. Due to applicant amendment to the claim(s) a new rejection is set forth in view of Wang (US-2010/0137733-A1), Feng “The Fabrication and Characterization of a Formaldehyde Odor Sensor using Molecularly Imprinted Polymers”, Dickert “QCM and SAW Transducers Allow Analyte Detection from nanometer to micrometer dimensions using imprinting techniques”, and Cai (US-2017/0227508-A1). Further, please note that due to amendments to the claims 112(a) and 112(b) rejections are set forth as seen above.
In the scenario where the claims are only directed to the molecularly imprinted polymer coated piezoelectric sensor, such as the claims filed 11/21/2025, applicant arguments filed 08/07/2026 are not persuasive and will be described herein, although Lipskier and Sun are not applied in the current rejections.
Applicant argues on page 5 that Figure 2a of Lipskier illustrates an example of a sensor using a surface wave transducer of Rayleigh wave type, and that the present invention is different because the molecular imprinted polymer film or nanoparticle is used for detecting frequency changes.
Examiner does agree that column 4 lines 27-53 describes that Figure 2A of Lipskier shows a surface wave transducer. However, in this section it is also described that by recombining the output signal and the input signal, the output signal being amplified and being placed in phase with the input signal, an oscillating circuit having a characteristic resonance frequency is produced, and that when conditions of propagation of the surface acoustic waves are modified between the two electrodes, the phase variation induced is no longer the same and the oscillating circuit no longer resonates at the same frequency. And more specifically, column 4 lines 47-50 recites “In a sensor according to the invention, analysis of the variation in frequency makes it possible to monitor the capture of molecules by the sensitive layer.”
Therefore, the surface wave transducer of Lipskier will still be monitoring frequency changes.
Applicant argues on page 5 regarding Sun’s provisional filing date of April 13, 2018 is limited to disclosure of butylated hydroxytoluene and expressly directed to Alzheimer’s disease.
It is respectfully noted that the disclosure of Sun with the filing date of April 12, 2019 disclosures other analytes such as ethanol. Therefore, the disclosure of Sun with the filing date of April 12, 2019 still qualifies as prior art.
Applicant argues on page 5 that Sun fails the written description and enablement requirements because it does not demonstrate possession of the claimed template molecules nor provide sufficient guidance to practice the claimed sensors without undue experimentation, where the mere mention of a compound or disease context is insufficient to negate novelty or inventive step.
Firstly, it is noted that the claims require the target molecules to be selected from toluene, 4-ethylbenzamide, cyclohexane, n-pentanal, n-octanal, n-hexanal, n-nonanal, n-heptanal, 2-propanol, ethanol, acetone, acrolein, or combinations thereof.
Sun discloses various volatile organic compounds that are desirable to sense, as well as listing for various diseases the types of volatile organic compounds that are associated with the disease. Further, Sun discloses a molecularly imprinted polymer and how to create one in [0078], where [0082] more specifically describes that the analytes to be detected include but are not limited to acetone, acetic acid, butanal, carbon disulfide, ethanol, isopropyl alcohol, formaldehyde and methylene chloride. Therefore, Sun possessed the claimed template molecules (ethanol). Further, Sun was being used to teach the template molecules for Lipskier, where Lipskier teaches monitoring the variation in frequency. Thus the prior art provides sufficient guidance to practice the molecularly imprinted polymer coated piezoelectric sensor.
Please note in the final rejection page 5 mailed 12/29/2025, it was further provided that Sun teaches toluene, pentanal, octanal, hexanal, nonanal, heptanal, and acetone as possible analytes for various diseases/conditions.
Applicant argues on page 6 that the present claims recite a QCM coated with molecularly imprinted polymer material, either discrete polymer nanoparticles or an in-situ formed MIP film, specifically tailored to VOCs, and that in contrast Dicker’s disclosure of surface-imprinted films on acoustic transducers does not teach or suggest these specific limitations.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., in-situ formed MIP film) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Further, Dickert teaches both a quartz crystal microbalance and surface acoustic wave devices, where Figure 3 shows a quartz crystal microbalance.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., MIP nanoparticle as mentioned in the present invention formed as depicted in Figure 6) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Further, the claim does not limit the structure of the nanoparticles and only requires that they have a particle size ranging from 100 to 500 nm. Therefore, as long as the prior art teaches MIP nanoparticles within this range it will read on the claim, where the prior art may have additional structures due to the claim reciting “comprising”. Further, with regards to arguments that because the nanoparticles of Zhang are water compatible, and the claims do not require water compatibility and therefore the claimed product is different from Zhang it is again noted that the prior art may have additional structures. Zhang still teaches MIP nanoparticles with a size of 10-250 nm, and thus reads on the limitations of claim 32.
Additionally, arguments that the sensor has to work on exhaled breath, 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 structure is capable of performing the intended use, then it meets the claim.
It is believed that water compatibility would not prevent the MIP nanoparticles from being able to sense VOCs in breath.
Please note again that the arguments addressed above are relating to the claims that were previously filed when the invention was the molecularly imprinted polymer coated piezoelectric sensor not including the reference sensor and sensor chamber.
Other References Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sherwood (US-2018/0336970-A1) teaches a method for evaluating the presence of VOCs in a breath sample, where in Figure 7 it shows an airflow pathway 724 that enters a housing 720 through an airflow aperture, the housing 720 having a gas testing chamber 726 that holds a disposable sensor test strip 740 that may be oriented with its long axis parallel to the long axis of the housing 720 or may be inserted such that its long axis is perpendicular to the long axis of the housing 720 (Sherwood; abstract, [0082], [0083], [0086]).
Lin (US-2003/0060726-A1) teaches a diagnostic device that includes a sensory chamber 12, signal processing unit comprising an oscillator 15, a frequency counter 16, a digital/analogy recorder 17, microprocessor 18, database storage device 19, and a multi-sensor array 13 composed of 6 piezoelectric quartz crystal 21 where breath is injected via breath collecting device 22 into the sensory chamber 12 (Lin; [0022], Figure 2).
Gouma (US-2006/0277974-A1) teaches where medical studies have recently associated certain gaseous constituents of human breath with specific types of diseases, where acetone, formaldehyde, and ethanol are examples of such constituents (Gouma; [0023]).
Suzuki (US-2016/0084786-A1) teaches where VOCs to be detected by a semiconductor gas sensor includes ethanol, methanol, acetone, toluene, xylene, ethyl acetate, formaldehyde, acetaldehyde, chloroform or paradichlorobenzene (Suzuki; [0007], [0008]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA LYLE whose telephone number is (571)272-9856. The examiner can normally be reached 8:30-5:00 M-Th.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759
Prosecution Insights