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 .
Summary
Claims 1, 32-33, 46-47, 63-64, 66-67, 71, 73, 78, 80, 82-83, 85-86, 90, 97, and 107 are pending in this office action. Claims 2-31, 34-45, 48-62, 65, 68-70, 72, 74-77, 79, 81, 84, 87-89, 91-96, 98-106, and 108-180 are cancelled. All pending claims are under examination in this application.
Priority
The current application was filed on January 17, 2025 is a 371 of PCT/US2023/070772 filed July 21, 2023, which in turn claims domestic priority to provisional patent application 63/391,036 filed July 21, 2022.
Information Disclosure Statement
Receipt of the Information Disclosure Statements filed on January 17, 2025 and May 4, 2026 are acknowledged. A signed copy of both documents are attached to this office action.
Objections to the Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because Fig. 2A-2D do not have the x-axis labeled with “wavelength (nm)”. Furthermore, Fig. 2D also has an unreadable x-axis and the y-axis is unlabeled. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Objections
Claims 1, 32-33, 46-47, 63-64, 66-67, 71, 73, 78, 80, 82-83, 85-86, 90, 97, and 107 are objected to because of the following informalities:
Claims 1, 63, 71, and 85: Please amend the text “…or precursor thereof…” to either “…or precursors thereof…” or “…or a precursor thereof…” depending upon the implied meaning of the claim.
Dependent claims 32-33, 46-47, 63-64, 66-67, 71, 73, 78, 80, 82-83, 86, 90, 97, and 107 fail to cure the defect of independent claims 1 and 85, and therefore are included here.
Appropriate correction is required.
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, 73, 85, 86, 97, and 107 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mault (US2002/0061495A1).
Mault is considered the closest prior art to the claimed invention as it teaches a sensor system for diagnosing dental conditions (see title). Furthermore, Mault discloses a sensor system for diagnosing dental conditions includes a sensor unit which is in contact with an oral fluid such as saliva or gas, and which is operative to provide detectable signals indicative of at least two of hydrogen ion concentration, hydroxyl ion concentration, calcium, phosphate, sulfur, sulfur containing compounds, nitrogen containing compounds, microbial metabolites, and microbes. The system includes a signal processor which is in communication with the sensor unit which operates to provide a processed signal indicative of one or more dental conditions. The signal processor transmits the processed signal to a storage and display device which displays a user detectable diagnostic message indicative of a dental condition, or suggestive of a remedial action (see abstract).
Regarding instant claim 1, Mault teaches a device for detection of a presence or absence of a dental caries, and/or cavity or cavities, and/or cavity activity risk, and/or caries risk, or precursor thereof. The necessary citations within Mault that pertain to instant claim 1 are presented in Table I.
Table I
Instant Claim 1
Mault Citations
A device for detection of a presence or absence of a dental caries, and/or cavity or cavities, and/or cavity activity risk, and/or caries risk, or precursor thereof, comprising:
Mault discloses a device for detection of a presence or absence of a dental caries, and/or cavity or cavities, and/or
cavity activity risk and/or caries risk, or precursor thereof (a sensor system for diagnosing dental conditions, see para. [0013]; warns the user that conditions exist, favorable for the formation of dental caries, see para. [0035]), comprising:
(a) a support, the support being configured for grasping;
(a) a support, the support being configured for grasping (structure 10 has a holding end 24 adapted to be held between the fingers inert material 20 forms the inner body of the holding end, see para. [0027]; also see FIG. 1);
(b) a substrate attached to or layered upon the support and being suitable for absorption or containing a sensing agent and detection of the sensing agent without interference; and
(b) a substrate attached to or layered upon the support and being suitable for absorption or containing a sensing agent and detection of the sensing agent without interference (outer surface of the sensing end 26 is formed by a permeable layer 12, which surrounds indicating regions 14, 16, and 18. Indicating regions are adapted to have a visible response to the oral environment. An inert material 20 forms the inner body of the holding end, and is largely surrounded by film 22 which is adapted to assist holding of the sensor structure, see para. [0027]; also see FIG. 1; detection of two different wavelengths may also be used to more accurately determine the color response of the indicating chemistry, as the ratio of attenuation at two or more suitable wavelengths is a sensitive method of determining pH change from calorimetric pH indicators, see para. [0042]); and
(c) a sensing agent, the sensing agent being suitable for providing a color change which is indicative of a pH value associated with the presence or absence of a dental caries, and/or cavity or cavities, risk for caries, caries activity, or precursor thereof.
(c) a sensing agent, the sensing agent being suitable for providing a color change which is indicative of a pH value associated with the presence or absence of a dental caries, and/or cavity or cavities, risk for caries, caries activity, or precursor thereof (a permeable layer 32, a pH-sensitive colorimetric response layer 34, see para. [0034]; also see FlG. 2; a sensor system for diagnosing dental conditions, see para. [0013]; warns the user that conditions exist favorable for the formation of dental caries, see para. [0035]; color response to ion levels in the saliva is useful in preventing dental caries, see para. [0036]).
Further, in regards to the limitation relating to "for detection of a presence or absence of a dental caries, and/or cavity or cavities, and/or cavity activity risk, and/or caries risk, or precursor thereof," 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 distinguish the claimed invention from the prior art. If the prior art is capable of performing the intended use, it meets the limitation for detection of a presence or absence of a dental caries, and/or cavity or cavities, and/or cavity activity risk, and/or caries risk, or precursor thereof.
Regarding instant claims 73 and 97, Mault teaches wherein the device detects demineralization. Mault discloses wherein the device detects demineralization from calcium and phosphate ions (see para. [0013]). Regarding instant claim 85, Mault teaches a method of detecting a presence or absence of a dental caries, and/or cavity or cavities, or precursor thereof, comprising:(a) contacting a surface of a tooth with a sensing agent, or a support and/or substrate comprising the sensing agent, the sensing agent being configured to colorimetrically detect pH of saliva,plaque, or gingival crevicular fluid; and (b) determining a color change in the sensing agent, the color change being indicative of a pH value that is associated with the presence or absence of tooth demineralization, dental caries, caries risk, caries activity level, caries associated bacterial activity, and/or cavity or cavities, or precursor thereof, and/or risk of developing dental caries, and/or cavity or cavities presence or activity.
Mault discloses a method of detecting a presence or absence of a dental caries, and/or cavity or cavities, or precursor thereof (detect the acidity, ion levels, and bacteria content of saliva samples extracted from the mouth, see para. [0033]; warns the user that conditions exist favorable for the formation of dental caries, see para. [0035]), comprising:
(a) contacting a surface of a tooth with a sensing agent, or a support and/or substrate comprising the sensing agent (structure 10 has a holding end 24 adapted to be held between the fingers inert material 20 forms the inner body of the holding end, see para. [0027]; also see FIG. 1), the sensing agent being configured to colorimetrically detect pH of saliva, plaque, or gingival crevicular fluid (a permeable layer 32, a pH-sensitive colorimetric response layer 34, see para. [0034]; also see FIG. 2; a sensor system for diagnosing dental conditions, see para. [0013]; warns the user that conditions exist favorable for the formation of dental caries, see para. [0035]; color response to ion levels in the saliva, is useful in preventing dental caries, see para. [0036]); and
(b) determining a color change in the sensing agent, the color change being indicative of a pH value that is associated with the presence or absence of tooth demineralization, dental caries, caries risk, caries activity level, caries associated bacterial activity, and/or cavity or cavities, or precursor thereof, and/or risk of developing dental caries, and/or cavity or cavities presence or activity (a permeable layer 32, a pH-sensitive colorimetric response layer 34, see para. [0034]; also see FIG. 2; a sensor system for diagnosing dental conditions, see para. [0013]; warns the user that conditions exist favorable for the formation of dental caries, see para. [0035]; color response to ion levels in the saliva is useful in preventing dental caries, see para. [0036]).
Regarding instant claim 86, Mault teaches wherein the contacting is interproximal.
Mault discloses wherein the contacting is interproximal (sensor structure shown generally at 10, preferably in the shape of a toothpick. The structure 10 has a holding end 24 adapted to be held between the fingers, and a sensing end 26, adapted to be placed in the mouth of a person, see para. [0027]; also see FIG. 1 and FIG. 3).
Regarding instant claim 107, Mault teaches wherein the method detects a remineralizable dental lesion or improving oral hygiene.
Mault discloses that their device monitors dental health (oral hygiene) (see para. [0002] and [0012]). Therefore, over time Mault’s device can detect the improvement of dental health (oral hygiene).
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 non-obviousness.
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.
Claims 1, 32-33, 46-47, 63-64, 66-67, 71, 78, 80, 82-83, 85, and 90 are rejected under 35 U.S.C. 103 as being unpatentable over Mault in view of Ramji et al. (US2005/0058602A1), Jabbarzadeh et al. (US2020/0072758A1), and Shanjani et al. (WO2017/218947A1).
[The Examiner is going to introduce each new reference and then combine them where appropriate to reject the instant claims.]
1. Ramji et al.
Ramji et al. teach a dye composition and method for detection of demineralized lesions in teeth (see title). Additionally, Ramji et al. disclose that the present invention relates to an oral care dye composition for detection of demineralization lesions comprising: a first phase (or first composition) comprising from about 0.1% to about 10% by weight of the composition of a blue dye and mixtures thereof; a second phase (or second composition) comprising from about 0.1% to about 10% by weight of the
composition of a red dye or a yellow dye or mixtures thereof; a safe and effective amount of a solvent wherein the dye is soluble in the solvent; and optionally a safe and
effective amount of a flavor; wherein the composition is effective for detection of demineralized lesions. The present invention further relates to method of visually highlighting demineralization lesions, in tooth surfaces, or a method of detecting the mineralization health of teeth, wherein the above dye composition is applied to the oral cavity or to the teeth, of a human or animal subject, in need thereof. In one embodiment a first dye composition and a second dye composition are applied, sequentially, to a human or animal subject 's oral cavity or teeth, in need thereof, wherein after the dye compositions are applied, the teeth are visually observed to assess demineralized lesions stained by the dyes (see abstract).
2. Jabbarzadeh et al.
Jabbarzadeh et al. teach pH indicator swabs for biomonitoring and diagnostics (see title). In addition, Jabbarzadeh et al. disclose medical swabs incorporating a pH indicator in an absorbent crosslinked hydrogel matrix. The medical swabs can provide
for visual monitoring of biological pH. The medical swabs can be used to monitor wounds, such as chronic wounds, burn wounds, surgical wounds, etc., as well as other biological fluids. The swabs can be used for early detection of chronic wounds and/or early detection of bacterial infections (see abstract).
3. Shanjani et al.
Shanjani et al. teach intraoral appliances with sensing (see title). Furthermore, Shanjani et al. disclose that detection of the placement of dental aligners in patient mouth on teeth for indication of wearing compliance. Described herein are apparatuses and methods for detecting wearing, including compliance, and for reliably transferring data, by wired or wireless direct or indirect communication of electronic compliance information to a smartphone. Also described herein are dental appliances that can detect physiological parameters related to respiration and sleep. Also described herein are aligner cases that enable NFC communication with electronic compliance indicator (ECI) devices and Bluetooth communication with smartphones (see abstract).
The teachings of Mault are disclosed above within the 35 U.S.C. §102 Section of this office action.
Ascertaining the Difference
Mault fails to disclose all of the claim limitations presented within this 35 U.S.C. §103 Section of this office action. However, the additional references of Ramji et al., Jabbarzadeh et al., and Shanjani et al. in combination with Mault reject the remaining instant claims in full.
Combination of Mault and Jabbarzadeh et al.
Regarding instant claim 32, Mault and Jabbarzadeh et al. teach wherein the device is suitable for displaying a color change of a first color to a second color that indicates a specific pH value.
Jabbarzadeh et al. teach pH indicator swabs for biomonitoring and diagnostics (see title). Furthermore, Jabbarzadeh et al. disclose that FIG. 1 illustrates colorimetric transition of the anthocyanin swabs in buffer solutions with different pH values. The original swab was purple at pH 7.0 (center) and it changed color from red to pink in acidic solutions (left) and blue to green (right) in basic solutions (see para. [0014] and FIG. 1 within Jabbarzadeh et al.). Furthermore, please see the discussion and citations within instant claim 1 for supporting rejection text.
Combination of Mault and Shanjani et al.
Regarding instant claim 33, Mault and Shanjani et al. teach wherein the device is suitable for displaying a color change of a first color to a second color that does not indicate a specific pH value.
Shanjani et al. teach intraoral appliances with sensing (see title). Additionally, Shanjani et al. disclose that alternatively or in combination, the monitoring device can be configured to provide data indicative of one or more characteristics of the patient's intraoral cavity or a portion thereof (e.g., teeth, gingiva, palate, lips, tongue, cheeks, saliva, airway), such as temperature, color, sound, vibration, motion, pH, conductivity, charge, resistance, capacitance, humidity, or gas flow. The characteristics of the patient's intraoral cavity can optionally be used to determine appliance usage and/or patient compliance… (see para. [00133] within Shanjani et al.).
Combination of Mault, Ramji et al., and Jabbarzadeh et al.
Regarding instant claim 46, Mault, Ramji et al., and Jabbarzadeh et al. teach wherein the device is suitable for displaying a color change of colored to colorless, or substantially colorless, that indicates a specific pH value.
This specific claim limitation would be seen as a design choice by the inventor. As such, a color change from colored to colorless would be observed based on the indicator selected by a skilled artisan (POSITA; person of ordinary skill in the art). The references of Mault, Ramji et al., and Jabbarzadeh et al. all disclose the use of color to monitor the pH of oral biological fluids (see instant claim 1 [Mault]; see instant claim 32 [Jabbarzadeh et al.]; and see the title, abstract, and claims of Ramji et al.).
Regarding instant claim 47, Mault, Ramji et al., and Jabbarzadeh et al. teach wherein the device is suitable for displaying a color change of colorless, or substantially colorless, to colored that indicates a specific pH value.
This specific claim limitation would be seen as a design choice by the inventor. As such, a color change from colored to colorless would be observed based on the indicator selected by a skilled artisan (POSITA). The references of Mault, Ramji et al., and Jabbarzadeh et al. all disclose the use of color to monitor the pH of oral biological fluids (see instant claim 1 [Mault]; see instant claim 32 [Jabbarzadeh et al.]; and see the title, abstract, and claims of Ramji et al.).
Regarding instant claim 63, Mault, Ramji et al., and Jabbarzadeh et al. teach wherein the dental caries, and/or cavity or cavities, or precursor thereof is not readily detectable with visual-tactile examination.
Mault teaches sensor system for diagnosing dental conditions (see title). Therefore, the data collected with the device from Mault monitors the oral health of a patient. The data would be indicative of conditions in the early stages which may not have manifested to visual-tactile dental examination.
Regarding instant claim 64, Mault, Ramji et al., and Jabbarzadeh et al. teach wherein the device is suitable for at-home detection.
Mault discloses the sensory device to monitor oral health to be placed in the user’s mouth (see claim 2 within Mault). If the data to be collected is over an extended period, then at-home use would be implied (see for example para. [0043] within Mault).
Regarding instant claim 66, Mault, Ramji et al., and Jabbarzadeh et al. teach wherein the device provides a signal that is visualizable by an unassisted eye.
Mault discloses visually detectable signals (see para. [0026] within Mault).
Regarding instant claim 67, Mault, Ramji et al., and Jabbarzadeh et al. teach wherein the device augments or supplants a cavity detection method, optionally wherein the device augments or supplants radiographic detection, or wherein the device supplants Quantitative Light-induced Fluorescence (QLF), Fibre-optic Transillumination (FOTI), Electrical Conductance (EC), fluorescence or dyed particles/nanoparticles, bitewing radiography, periapical radiography, panoramic radiography, or cone beam computed tomography ("CBCT").
Mault discloses the sensor structures of the present invention are operable to provide detectable signals indicative of at least two different parameters associated with dental health, and in specific embodiments, these detectable signals are provided simultaneously. The detectable signals may be directly, visually detectable. In other instances, the signals will only be visible after subsequent chemical treatment, in which instance they are also characterized as being chemically detectable. In yet other instances, the signals will be electronically detectable. All of such signals are collectively
termed detectable (see para. [0026] within Mault). The at least two different parameters include hydrogen ion, calcium ion, phosphate ion, sulfur, organosulfur compounds, nitrogen containing compounds, microbial metabolites, and microbes (see para. [0013] within Mault). These parameters would aid (augment or supplant) in the detection of cavities (enamel degradation; demineralization and/or lesions).
Regarding instant claim 71, Mault, Ramji et al., and Jabbarzadeh et al. teach wherein the pH value is about 5.5 and indicative of the presence of a dental caries, and/or cavity or cavities, or precursor thereof, and/or a risk of developing dental caries.
A skilled artisan (POSITA) would know that, for example, dental caries are associated with acidic pH from a healthy pH of approximately 7. The teachings of Mault, Ramji et al., and Jabbarzadeh et al. support the monitoring of oral health and the detection of acidic biological fluid (saliva pH) in the mouth.
Regarding instant claim 78, Mault, Ramji et al., and Jabbarzadeh et al. teach wherein the device detects a lack of activity of Streptococci mutans, Streptococcus sobrinus, and/or Lactobacilli spp., optionally wherein the device detects bacterial acid secretion after intentional activation of bacterial acid secretion, optionally wherein the device increases bacterial acid secretion and/or bacterial activity.
A skilled artisan (POSITA) would know that the bacterium Streptococci mutans produces a molecule called glucan which helps the bacteria to bind themselves to the teeth and form plaque deposits. The plaque bacteria metabolize sugars and carbohydrates and as a by-product form lactic acid. Tooth enamel is slightly soluble in the acidic environment which is produced (see para. [0004] within Mault). Furthermore, as stated above within instant claim 67, microbes can be monitored. Therefore, the device would be designed to detect the presence of Streptococci mutans.
Regarding instant claim 80, Mault, Ramji et al., and Jabbarzadeh et al. teach wherein the device distinguishes between active and arrested lesions.
A dental lesion is defined as any abnormal change, sore, growth, or area of damage in the teeth, gums, tongue, or soft tissues of the mouth (see PTO-892 NPL U). Mault does not use the term lesion. However, their device to diagnose dental conditions collects data that would allow the skilled artisan (POSITA) to investigate damage that may occur as a result of the detected oral environment (lesions; see title, abstract, and claims within Mault).
Ramji et al. teach a dye composition and method for detection of demineralized lesions in teeth (see title, abstract, and claims within Ramji et al.).
The Mault device would be able to detect oral lesions, if the oral environment supports the active damage or arrested damage to the teeth, gums, tongue, or soft tissues of the mouth. Both the Mault and Ramji et al. references give evidence for the detection of oral lesions.
Regarding instant claim 82, Mault, Ramji et al., and Jabbarzadeh et al. teach wherein the device detects a reversible dental lesion, optionally wherein the device detects the depth of the dental lesion.
Please see the discussion and citations within instant claim 80 for the necessary rejection text. Reversible dental lesions are areas of tooth damage or inflammation that can be completely healed, remineralized, or resolved without needing permanent, invasive restorations like root canals or deep extractions (see PTO-892 NPL V).
A skilled artisan (POSITA) would interpret the data from the device of Mault (see title, abstract, and claims within Mault) to determine the level of health concern for the patient. Visual inspection of the area would confirm if the tooth or soft tissue could be completely healed (reversible dental lesion).
Regarding instant claim 83, Mault, Ramji et al., and Jabbarzadeh et al. teach wherein the device detects a remineralizable dental lesion.
Please see the discussion and citations within instant claim 80 for the necessary rejection text. Both the Mault and Ramji et al. references support the detection of demineralized lesions in teeth (see title, abstract, and claims within Mault and Ramji et al.).
The device of Mault would identify/detect a demineralized lesion. After the patient is subjected to a healing environment to remineralize the area, the device would then detect a “normal” oral environment. Visual inspection by a skilled artisan (POSITA) would confirm the remineralizable dental lesion.
Regarding instant claim 90, Mault, Ramji et al., and Jabbarzadeh et al. teach wherein the method provides a signal that is visualizable by an unassisted eye, optionally wherein the method provides a signal through a device, optionally wherein the method provides a signal through a phone application, optionally wherein the method provides a signal based on an image analysis algorithm, optionally wherein the method provides a signal that is visualizable by a software through taking an image of the device.
Please see the discussion and citations within instant claim 83 for the necessary rejection text. The data collected by the Mault device would enable a skilled artisan (POSITA) to confirm that the oral biochemistry supports or does not support a healing or damaging environment. This would be confirmed through visual inspection of the unassisted eye.
Analogous Art
The Mault, Ramji et al., Jabbarzadeh et al., and Shanjani et al. references are directed to the same field of endeavor as the instant claims, that is, a device for detection of a presence or absence of a dental caries, and/or cavity or cavities, and/or cavity activity risk, and/or caries risk, or precursor thereof, as disclosed within instant claim 1.
Obviousness Analysis
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sensor system for diagnosing dental conditions disclosed by Mault, using the teachings of Ramji et al., Jabbarzadeh et al., and Shanjani et al. in order to arrive at the subject matter of the instant claims.
The Mault, Ramji et al., Jabbarzadeh et al., and Shanjani et al. references all have considerable overlap in the dental monitoring and detection arts. In this instant, Mault and Ramji et al. supply the template for the sensor system for diagnosing dental conditions, Jabbarzadeh et al. supplies the pH indicator swabs for biomonitoring and diagnostics, while Shanjani et al. supplies intraoral appliances with sensing. All references are directed to a device for dental monitoring and detection and therefore constitute analogous art under MPEP §2141.01(a). A POSITA would have reasonably consulted the four references when seeking to develop an enhanced sensor system for diagnosing dental conditions.
Given these teachings, a POSITA would have been motivated to combine the sensor system for diagnosing dental conditions as disclosed by Mault and Ramji et al., the pH indicator swabs for biomonitoring and diagnostics supplied by Jabbarzadeh et al., and intraoral appliances with sensing disclosed by Shanjani et al.
The modification constitutes a simple substitution of one known element for another to obtain a predictable result [MPEP §2143(I)(B)].
The combination represents the use of a known technique to improve a similar device in the same way [MPEP §2143(I)(C)].
The art provides a finite number of identified, predictable solutions, and the POSITA would have pursued the claimed configuration with a reasonable expectation of success [MPEP §2143(I)(E); KSR].
The combination of the sensor system for diagnosing dental conditions taught by Mault along with the use of the necessary claim limitations disclosed by Ramji et al., Jabbarzadeh et al., and Shanjani et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application.
Furthermore, the additional claim limitations taught by Ramji et al., Jabbarzadeh et al., and Shanjani et al. would have been viewed by a POSITA as routine design optimizations or known modifications for dental sensory devices. The motivation for doing so would have been to incorporate the enhanced oral health sensory materials from the secondary references to improve the device conceived by Mault. Implementing these features in Mault’s sensor system for diagnosing dental conditions would not require more than ordinary skill or routine experimentation.
Accordingly, the combination of Mault, Ramji et al., Jabbarzadeh et al., and Shanjani et al. provides all the elements of the claimed invention. The resulting improved sensor system for diagnosing dental conditions, constitutes no more than the predictable outcome of combining familiar prior art components, and therefore the claimed subject matter would have been obvious to a POSITA prior to the effective filing date of the invention.
Conclusion
No claims are allowed.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615
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