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 .
Response to Amendment
The amendments filed 02 JANUARY 2026 have been entered. Claims 1, 3 – 7, 9 – 19, and 22 are pending. Applicant’s amendments to the claims have overcome each and every objection to the claims previously applied in the office action dated 10 OCTOBER 2025. Applicant’s amendments to the claims have overcome each and every rejection to the claims under 35 U.S.C. 112 previously applied in the office action dated 10 OCTOBER 2025.
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 22 is 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 22 recites the limitation “computer in electrical communication with the memory, the computer configured to execute the machine executable code to case the computer to…”. The term “computer” is new matter that is not recited in the specification. There is no computer recited in the Applicant’s specification. Therefore, adequate disclosure is needed.
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, 3 – 7, 9 – 19 and 22 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 the limitation "the subject’s tooth" in line 5. There is insufficient antecedent basis for this limitation in the claim. While the subject has been previously introduced, there is no previous recitation of tooth. It is unclear to which tooth is being referred. For the purposes of examination, the term “the subject’s tooth” is deemed to claim “a tooth of the subject”. Claims 3 – 7 and 9 – 19 are similarly rejected due to their dependence on Claim 1.
Claim 1 (line 13) and Claim 22 (line 8) recites the limitation “indicates demineralization in the oral cavity of the subject” in line 13. It is unclear if this is intended to be the same or different than the demineralization in the oral cavity previously recited in the claim. For the purposes of examination, the term “indicates demineralization in the oral cavity of the subject” is deemed to claim “indicates the demineralization in the oral cavity of the subject.” Claims 3 – 7 and 9 – 19 are similarly rejected due to their dependence on Claim 1.
Claim 12 recites the limitation “a subject’s tooth” in line 3. It is unclear if this is intended to be the same or a different tooth than that recited in Claim 1, from which this claim depends. For the purposes of examination, the term “a subject’s tooth” is deemed to claim “the tooth of the subject”.
Claim 22 recites the limitation “determine a pH” in line 17. It is unclear if this is the same or different than the previously-recited pH in line 8 of the claim. For the purposes of examination, the term “determine a pH” is deemed to claim “determine the pH”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The limitation “wherein at least a portion of the oral sampling support substrate is configure to wrap around a subject’s tooth” does not further limit Claim 1’s limitation of “an oral sampling support substrate…is configured to wrap around a portion of the subject’s tooth”.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 22 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 22, the claim recites an apparatus, which is one of the statutory categories of invention (Step 1). The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Claim 22 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Claim 22 recites at least one step or instruction for observations, evaluations, judgments, and opinions, which are grouped as a mental process under the 2019 PEG. The claimed invention involves making observations, evaluations, judgments, and opinions, which are concepts performed in the human mind under the 2019 PEG.
Accordingly, Claim 22 recites an abstract idea.
Specifically, Claim 22 recites (underlined are observations, judgements, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) (additional elements bolded, see Step 2A, prong 2);
Claim 22:
A system for analyzing a bioresponsive interface, the system comprising:
an oral sampling device for identification of demineralization in an oral cavity of a subject, comprising a bioresponsive interface, the bioresponsive interface comprising silk fibroin and a pH sensing agent, wherein the pH sensing agent is present in the bioresponsive interface at a concentration in a range of 5% to 50% weight/volume, wherein the concentration is based on a total volume of the bioresponsive interface, wherein the bioresponsive interface undergoes a color change in response to a pH change in the oral cavity and wherein a pH of 5.5 or less indicates demineralization in the oral cavity of the subject;
a memory containing a non-transitory computer readable medium comprising machine executable code having stored instructions thereon for performing a method of analyzing the bioresponsive interface;
a camera configured to photograph a region of interest on the oral sampling device; and
a computer in electrical communication with the memory, the computer configured to execute the machine executable code to cause the computer to:
determine a pH of the region of interest on the oral sampling device based on a color of the region of interest; and
output a report that includes the pH of the region of interest
(observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
These underlined limitations describe a mental process, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claim suggests that the limitations cannot be practically performed by a medical, biomedical or engineering professional with the aid of a pen and paper; their knowledge gained from education, background, or experience; or by using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner additionally notes that nothing from the claim suggests and undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps. For example, in Claim 22, these limitations include:
Observation and Judgment to determine a pH of the region of interest on the oral sampling device based on a color of the region of interest
Communicate a report that includes the pH of region of interest (write or tell someone a pH result from observation and judgment of the color change)
all of which are grouped as mental processes under the 2019 PEG.
As claimed, the aforementioned limitations are mental processes that would be performed by a medical, biomedical or engineering professional using their education, background, and experience, and a pen and paper.
Accordingly, as indicated above, the above-identified claim recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract ideas in Claim 22 are not integrated into a practical application under 2019 PEG because the additional elements (identified above in Claim 22), either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use. More specifically, within the Claim 22, the additional elements of:
“oral sampling device”
“bioresponsive interface”
“memory”
“camera”
“computer”
Additional elements recited include a “oral sampling device”, “bioresponsive interface” to undergo a color-change, “memory” to store, “camera” to photograph, and “computer” to execute code, determine, and output. These components are recited at a high level of generality. These generic hardware component limitations for the “oral sampling device”, “bioresponsive interface”, “memory”, “camera”, and “computer” are no more than mere instructions to apply the exception using a generic computer component. As such, these additional elements do not impose any meaningful limits on practicing the abstract idea.
Additional elements from Claim 22 includes pre-solution activity limitations, such as:
an oral sampling device for identification of demineralization in an oral cavity of a subject, comprising a bioresponsive interface, the bioresponsive interface comprising silk fibroin and a pH sensing agent, wherein the pH sensing agent is present in the bioresponsive interface at a concentration in a range of 5% to 50% weight/volume, wherein the concentration is based on a total volume of the bioresponsive interface, wherein the bioresponsive interface undergoes a color change in response to a pH change in the oral cavity and wherein a pH of 5.5 or less indicates demineralization in the oral cavity of the subject;
a memory containing a non-transitory computer readable medium comprising machine executable code having stored instructions thereon for performing a method of analyzing the bioresponsive interface;
a camera configured to photograph a region of interest on the oral sampling device; and
a computer in electrical communication with the memory, the computer configured to execute the machine executable code
These pre-solution measurement elements are insignificant extra-solution activity, setting up the parameters of the system, and serve as data-gathering for the subsequent steps.
The “oral sampling device”, “bioresponsive interface”, “memory”, “camera”, and “computer” as recited in Claim 22 are generically recited computer and hardware elements which does not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract ideas identified above in Claim 22 are not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer processor as claimed. In other words, this claim is merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by this claim over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in this claim. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in in Claim 22 is not integrated into a practical application under the 2019 PEG.
Accordingly, Claim 22 is directed to an abstract idea under 2019 PEG.
Step 2B –
Claim 22 does not include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
This claim requires the additional elements of: “oral sampling device”, “bioresponsive interface”, “memory”, “camera”, and “computer” as recited in Claim 22.
The additional elements of the “oral sampling device”, “bioresponsive interface”, “memory”, “camera”, and “computer” in claim 22, as discussed with respect to Step 2A Prong Two, amounts to no more than mere instructions to apply the exception using generic computer and hardware components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per applicant’s specification, the “oral sampling device” is described in [0007] “an oral sampling device…may have various configurations”; [0034] that it “can change color upon contacting a tissue”; and [0053] “various form factors” including “mouth tray or dental aligner”, [0055] “ a paper point”, [0057] “dental floss”, [0059] “lollipop” or “candy”. The “oral sampling device” is shown as a variety of different types of embodiments in Figs 1 (A-B) and 2 (A – B) as “oral sampling device 10”, and as “oral sampling device 10” generic box element in Figure 6.
Per applicant’s specification, the “bioresponsive interface” is described at [0036] as including a biopolymeric matrix with many exemplar options “including, but are not limited to, fibroins, silk fibroin, collagens…”, and [0048] “may change color in response to a change in pH or a concentration of a chemical species…in the oral cavity”. It is identified on a variety embodiments on mediums in Figs 1 – 4 as “bioresponsive interface” 14.
Per applicant’s specification, the “memory” is described generically in [0063] as containing machine executable code and being in electrical communication with the control system. There is no additional mention of this structure in the specification, nor is it featured in a figure.
Per applicant’s specification, the “camera” is described generically in [0077] as either being an electronic reader or a camera “(i.e. Canon EOS Rebel T1i)”, each capable of “collecting images”. The “camera” is shown as “camera” 28 generic box element in Figure 6.
Per applicant’s specification as described in the 122(f) claim interpretation above, the “computer” is not described in the specification or shown in a figure.
Accordingly, in light of Applicant’s specification, the claimed terms “oral sampling device”, “bioresponsive interface”, “memory”, “camera”, and “computer” are reasonably construed as a generic computing device or hardware. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “oral sampling device”, “bioresponsive interface”, “memory”, “camera”, and “computer”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claim 22 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatus of Claim 22 is directed to applying an abstract idea as identified above on a general-purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claim 22 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements for Step 2A Prong 2 in Claim 22 do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claim amounts to significantly more than the abstract idea itself. Thus, Claim 22 merely applies an abstract idea to a computer and does not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claim 22 amounts to significantly more than the abstract idea itself. Accordingly, Claim 22 is not patent eligible and rejected under 35 U.S.C. 101.
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.
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, 3 – 4, 6 – 7, 9 – 12, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Jabbarzadeh et. al. (US 2020/0072756) in view of Seal et. al. (US 2021/0187128) and Perdido Bay Dental (“pH Balance and Your Teeth”; Reference U on PTO-892) and Prietto et. al. (“Ultrafine fibers of zein and anthocyanins as natural pH indicator”; Reference V on PTO-892) and Gathani (US Patent No. 5357989).
Regarding Claim 1, Jabbarzadeh discloses An oral sampling device for an oral cavity ([Abstract], [0046] “sample collection…mouth”), the oral sampling device comprising:
an oral sampling support substrate ([0046] “medical swab”), wherein the oral sampling substrate is sized to be received within the oral cavity of the subject ([0046] “medical swab”); and
a bioresponsive interface coupled to the oral sampling support substrate ([0027] “The medical swabs include the pH indicator retained within a crosslinked hydrogel matrix”), the bioresponsive interface ([0027] “the pH indicator retained with a crosslinked hydrogel matrix”) a pH sensing agent (Fig 1, [0026] “suitable pH indicators”; [0027] “the pH indicator retained with a crosslinked hydrogel matrix”), wherein the pH sensing agent is present in the bioresponsive interface ([0027] “the pH indicator retained with a crosslinked hydrogel matrix”)
wherein the bioresponsive interface undergoes a color change (Fig 1; [0025] “colorimetric pH indicator…a relatively rapid color change”; [0027] “pH indicator retained with a crosslinked hydrogel matrix”) in response to a pH change in the oral cavity ([0025] “…with change in pH”; [0046] “A medical swab can be utilized to sample…from the…mouth…throat”)(Examiner notes that the region of interest can broadly be the whole mouth interior or throat)
Jabbarzadeh does not specifically disclose identification of demineralization, the bioresponsive interface comprising silk fibroin, wherein the pH sensing agent is present in the bioresponsive interface at a concentration in a range of 5% to 50% weight/volume, wherein the concentration is based on a total volume of the bioresponsive interface, wherein a pH of 5.5 or less indicates demineralization in the oral cavity of the subject and is configured to wrap around a portion of the subject’s tooth.
Seal teaches an electrospun nanofibrous silk fibroin mat infused with a reactive oxygen species (ROS) detection reagent to detect environmental changes at a wound site. Specifically for Claim 1, Seal teaches the biopolymeric matrix comprising silk fibroin ([0115] “nanofibrous silk fibroin mats were infused with Amplex red dye for a real-time sensing of the oxidative stress in the wounds…”; [0012] “degree of color change in the electrospun nanofibrous mat to a control to measure an amount of ROS at the wound site of the patient.”; [Abstract] “reactive oxygen species”; [0020] “Electrospinning of the silk fibroin solution leads into the formation of nanofibrous silk fibroin mats.”; [0074])
Jabbarzadeh and Seal both use color-changing indicator agents coated with delivery biopolymeric matrices to determine changes in an environmental parameter of body tissues, Jabbarzadeh’s biopolymeric matrix being a swab with a hydrogel matrix (including collagen) with a color changing pH indicator to respond to environmental pH changes and Seal’s biopolymeric matrix electrospun fibroin mat with polyethylene oxide (PEO) with a color changing indicator responding to reactive oxygen species environment changes at wounds. Seal provides a motivation to combine at [0074] “The silk fibroin mats were electrospun from the silk fibroin solution blended with polyethylene oxide (PEO), which is also a biocompatible polymer” A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize coating the color-changing indicator on silk fibroin would be useful for detecting environmental change issues associated with the body or particularly at wound sites, as it is biocompatible with open sores.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the swab medium with a color-changing indicator for determining pH of an oral sample disclosed in Jabbarzadeh with the silk fibroin for the medium to carry the pH color indicator as taught by Seal, creating a single oral pH sampling device that can be used close to wound sites for determining environmental changes in the area with visual color change indication.
Seal does not teach does not teach identification of demineralization, wherein the pH sensing agent is present in the bioresponsive interface at a concentration in a range of 5% to 50% weight/volume, wherein the concentration is based on a total volume of the bioresponsive interface, and wherein a pH of 5.5 or less indicates demineralization in the oral cavity of the subject and is configured to wrap around a portion of the subject’s tooth.
Perdido Bay Dental teaches that a healthy mouth has a neutral pH, and that at a pH of 5.5, teeth begin to demineralize. Specifically for Claim 22, Perdido Bay Dental teaches for identification of demineralization ([Page 1, “The pH Range and Your Mouth” Section, Paragraph 1] “At a pH of 5.5 the teeth begin to demineralize, putting them at risk for cavities.”) and wherein a pH of 5.5 or less indicates demineralization in the oral cavity of the subject ([Page 1, “The pH Range and Your Mouth” Section, Paragraph 1] “At a pH of 5.5 the teeth begin to demineralize…A healthy mouth is in the neutral pH range”, [Page 1, Paragraph 2] “pH value of 7 is neutral”).
Jabbarzadeh indicates at Figure 3, “Yellow, pH: 5.5” that it can indicate and measure a pH of 5.5 on a defined color scale. Perdido Bay Dental provides a motivation to combine at [Page 1, “The pH Range and Your Mouth” Section, Paragraph 1] with “At a pH of 5.5 the teeth begin to demineralize, putting them at risk for cavities.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that setting a pH of 5.5 as a notable threshold for observation of an oral pH measurement device result would be useful for determining if there possible tooth demineralization present that could lead to cavities.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the swab medium with a color-changing indicator for determining pH of an oral sample (that can measure a pH of 5.5.) disclosed in Jabbarzadeh with the pH of 5.5 threshold for tooth demineralization taught by Perdido Bay Dental, creating a single oral pH sampling device that can be used to evaluate oral pH consistent with the possibility of tooth demineralization and cavity formation.
Perdido Bay Dental does not teach wherein the pH sensing agent is present in the bioresponsive interface at a concentration in a range of 5% to 50% weight/volume, wherein the concentration is based on a total volume of the bioresponsive interface, and is configured to wrap around a portion of the subject’s tooth.
Prietto teaches pH sensitive indicator membranes used for pharmaceutical, food, and packaging applications, incorporating zein fiber(protein extracted from corn [Page 2735, Left column, Paragraph 3]) and 5% (w/v) anthocyanins indicators [Abstract]. Specifically for Claim 1, Mirani teaches wherein the pH sensing agent is present in the bioresponsive interface at a concentration in a range of 5% to 50% weight/volume ([Page 2740, Right Column, 2nd Full Paragraph] “Zein solutions at 30% (w/v) polymer concentration, containing 3%, 4% or 5% (w/v) anthocyanins… ultrafine fibers with anthocyanins exhibited vivid color changes depending on pH…”; [Abstract]), wherein the concentration is based on a total volume of the bioresponsive interface [Page 2740, Right Column, 2nd Full Paragraph] “Zein solutions at 30% (w/v) polymer concentration, containing 3%, 4% or 5% (w/v) anthocyanins.”; [Abstract])
Prietto provides a motivation to combine at [Page 2738, Right Column, 1st Full paragraph] with “… increasing red color intensity as the anthocyanin content within the ultrafine fibers increased from 3% to 5% (Fig. 2B, C, D).”; [Page 2739, Left Column, Paragraph 2] “The increase of anthocyanin concentration in the membranes of 3% (Fig. 3B) to 5% (Fig. 3D) resulted in a greater variation in color under different pH conditions.”; and [Page 2735, Right Column] “…naturally occurring food-grade materials…” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that increasing the concentration of an anthocyanin indicator on biomaterial to at least 5% would be useful for more vibrant pH indication using a food-safe indicator material.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the swab medium with a color-changing indicator for determining pH of an oral sample disclosed in Jabbarzadeh with the food safe 5% concentration of anthocyanin pH indicator dye on its interface medium taught by Prietto, creating a single oral pH sampling device that can have vibrant color changing to indicate pH using naturally-occurring, food-grade anthocyanin dye material.
Prietto does not specifically teach is configured to wrap around a portion of the subject’s tooth.
Gathani teaches a dental floss with a pH sensitive dye coating for sensing the pH in a subject’s mouth between the teeth. Specifically for Claim 12, Gathani teaches is configured to wrap around a portion of the subject's tooth ([Col 1, Lines 22 – 23] “a dental cleansing strand member impregnated and/or coated with a pH sensitive dye”; [Col 1, Line 4] “a floss or tape”)(Examiner notes that floss can be routed around a portion of the subject’s tooth by passing through the gaps on each side of the tooth.).
Jabbarzadeh and Gathani both use color-changing indicator agents coated on delivery mediums to determine pH of body tissues, Jabbarzadeh’s medium being a swab and Gathani’s medium being dental floss or tape. Gathani provides a motivation to combine at [Col 1, Lines 24 – 27] with “Such a strand member constitutes a dental caries diagnostic means which detects the presence of an acid pH plaque, thus immediately alerting the user to the presence or potential presence of dental disease.” A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize coating the color-changing indicator on dental floss would be useful for detecting pH issues in between the teeth during a user’s regular dental routine, alerting them to potential dental disease.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the swab medium with a color-changing indicator for determining pH of an oral sample disclosed in Jabbarzadeh with the dental floss for the medium to carry the pH color indicator as taught by Gathani, creating a single oral pH sampling device that can be used as part of one’s regular dental routine to help detect dental disease.
Regarding Claim 3, Jabbarzadeh in view of Seal, further in view of Perdido Bay Dental, further in view of Prietto, further in view of Gathani discloses as described above, The oral sampling device of claim 1. For the remainder of Claim 3, Jabbarzadeh discloses wherein the pH sensing agent ([0026] “suitable pH indicators”) is selected from bromocresol green, chlorophenol red ([0026] “…chlorophenol red”), or nitrazine yellow ([0026] “…nitrazine yellow”).
Regarding Claim 4, Jabbarzadeh in view of Seal, further in view of Perdido Bay Dental, further in view of Prietto, further in view of Gathani discloses as described above, The oral sampling device of claim 1. For the remainder of Claim 4, Jabbarzadeh discloses wherein the pH sensing agent is an anthocyanin (Fig 1, [0014] “anthocyanin swabs…pH values”; [0026] “suitable pH indicators include…anthocyanin”).
Regarding Claim 6, Jabbarzadeh in view of Seal, further in view of Perdido Bay Dental, further in view of Prietto, further in view of Gathani discloses as described above, The oral sampling device of claim 1. For the remainder of Claim 6, Jabbarzadeh discloses wherein the bioresponsive interface ([0025] “colorimetric pH indicator”) undergoes the color change ([0025] “colorimetric pH indicator…a relatively rapid color change”) in response to a pH change in the oral cavity ([0025] “…with change in pH”; [0046] “A medical swab can be utilized to sample…from the…mouth”).
Regarding Claim 7, Jabbarzadeh in view of Seal, further in view of Perdido Bay Dental, further in view of Prietto, further in view of Gathani discloses as described above, The oral sampling device of claim 1. For the remainder of Claim 7, Jabbarzadeh discloses wherein the bioresponsive interface further comprises ([0028] “matrix polymer”) includes a biopolymer ([0028] “The matrix polymer can include…natural hydrogel-forming polymers.”) selected from the group consisting of actin, collagen ([0028] “hydrogel matrix polymers can include…collagen”), catenin, claudin, coilin, elastin, elaunin, extensin, fibrillin, fibroin, keratin, lamin, laminin, tublin, zein protein, and combinations thereof.
Regarding Claim 9, Jabbarzadeh in view of Seal, further in view of Perdido Bay Dental, further in view of Prietto, further in view of Gathani discloses as described above, The oral sampling device of claim 1. For the remainder of Claim 9, Jabbarzadeh discloses wherein the bioresponsive interface is coated onto an exterior surface of the oral sampling support substrate ([0041] “a medical swab can include the crosslinked hydrogel matrix coated on an absorptive substrate…fibrous wadding…”; [0027] “the pH indicator retained with a crosslinked hydrogel matrix”)(Examiner notes that the coating on the matrix would be on an exterior surface of it.)
Regarding Claim 10, Jabbarzadeh in view of Seal, further in view of Perdido Bay Dental, further in view of Prietto, further in view of Gathani discloses as described above, The oral sampling device of claim 1. For the remainder of Claim 10, Jabbarzadeh discloses wherein the bioresponsive interface ([0010] pH indicator”) is intermixed within a body of the oral sampling support substrate ([0010] “pH indicator retained within the crosslinked absorbent hydrogel matrix.”; [0041] “an absorptive supporting substrate can include…cotton based fibers…foam…sponge”; [0042] “a precursor solution can be coated on individual fibers of a fibrous supporting substrate…Coating can be carried out by dip coating…”)(Examiner notes that if the material is absorbent and “dipped”, then the liquid would get deeper than surface level, or within the support substrate.).
Regarding Claim 11, Jabbarzadeh in view of Seal, further in view of Perdido Bay Dental, further in view of Prietto, further in view of Gathani discloses as described above, The oral sampling device of claim 1. For the remainder of Claim 11, Jabbarzadeh discloses wherein at least a portion of the oral sampling support substrate ([0046] “medical swab”); is sized to fit between a subject's teeth (Fig 1, [0046] “A medical swab can be utilized to sample…from the…mouth, nose…”)(Examiner notes that a medical swab can fit in a mouth between a subject’s jaws, which would be between upper and lower teeth.)
Regarding Claim 12, Jabbarzadeh in view of Seal, further in view of Perdido Bay Dental, further in view of Prietto, further in view of Gathani discloses as described above, The oral sampling device of claim 1. For the remainder of Claim 12, Jabbarzadeh does not specifically disclose wherein at least a portion of the oral sampling support substrate is configured to wrap around a subject's tooth.
Gathani teaches a dental floss with a pH sensitive dye coating for sensing the pH in a subject’s mouth between the teeth. Specifically for Claim 12, Gathani teaches wherein at least a portion of the oral sampling support substrate is configured to wrap around a subject's tooth ([Col 1, Lines 22 – 23] “a dental cleansing strand member impregnated and/or coated with a pH sensitive dye”; [Col 1, Line 4] “a floss or tape”)(Examiner notes that floss can be routed around a tooth by passing through the gaps on each side of the tooth.).
The motivation for Claim 12 to combine Jabbarzadeh with Gathani is the same as that described in more detail in Claim 1. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the swab medium with a color-changing indicator for determining pH of an oral sample disclosed in Jabbarzadeh with the dental floss for the medium to carry the pH color indicator as taught by Gathani, creating a single oral pH sampling device that can be used as part of one’s regular dental routine to help detect dental disease.
Regarding Claim 17, Jabbarzadeh in view of Seal, further in view of Perdido Bay Dental, further in view of Prietto, further in view of Gathani discloses as described above, The oral sampling device of claim 1. For the remainder of Claim 17, Jabbarzadeh does not disclose wherein the oral sampling device has a form factor of dental floss, wherein the oral sampling support substrate is composed an elongate string and the bioresponsive interface is coupled to an exterior surface of the elongate string.
Gathani teaches wherein the oral sampling device has a form factor of dental floss ([Col 1, Lines 22 – 23] “a dental cleansing strand member impregnated and/or coated with a pH sensitive dye”; [Col 1, Line 4] “a floss or tape”), wherein the oral sampling support substrate is composed an elongate string ([Col 1, Lines 22 – 23] “a dental cleansing strand member”; [Col 1, Line 4] “a floss or tape”), and the bioresponsive interface is coupled to an exterior surface of the elongate string ([Col 1, Lines 22 – 23] “a dental cleansing strand member…coated with a pH sensitive dye”)
The motivation for Claim 17 to combine Jabbarzadeh and Gathani is the same as that described in more detail in Claim 1. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the swab medium with a color-changing indicator for determining pH of an oral sample disclosed in Jabbarzadeh with the dental floss for the medium to carry the pH color indicator as taught by Gathani, creating a single oral pH sampling device that can be used as part of one’s regular dental routine to help detect dental disease.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Jabbarzadeh et. al. (US 2020/0072756) in view of Seal et. al. (US 2021/0187128) and Perdido Bay Dental (“pH Balance and Your Teeth”; Reference U on PTO-892) and Prietto et. al. (“Ultrafine fibers of zein and anthocyanins as natural pH indicator”; Reference V on PTO-892) and Gathani (US Patent No. 5357989) in further view of Hohlbein et. al. (US 2012/0322023).
Regarding Claim 5, Jabbarzadeh in view of Seal, further in view of Perdido Bay Dental, further in view of Prietto, further in view of Gathani discloses as described above, The oral sampling device of claim 1. For the remainder of Claim 5, Jabbarzadeh does not disclose wherein the pH sensing agent is a carotenoid.
Hohlbein teaches a toothbrush device determines pH of the mouth and saliva with color-changing sensing indicator agents including a carotenoid. Specifically for Claim 5, Hohlbein teaches wherein the pH sensing agent is a carotenoid ([0034] “detector 24…detect any suitable marker or trigger in the saliva…pH…a particular pH or range of pH”; [0052] “agent 28…comprise a dye”; [0053] “dyes can include…beta-carotene”; [0063] “low saliva pH or local pH…could be detected using a releaser 26”; [0066] “agent 28 could be attached to the releaser 26”)
Both Jabbarzadeh and Hohlbein use color-changing indicator agents to determine pH of body tissues, Jabbarzadeh using a swab delivering the color changing indicator to contact the mouth and Hohlbein using a toothbrush to deliver the color changing indicator to contact the mouth and saliva. Hohlbein provides a motivation to combine at [0053] with “ Ideally, the dye will be used in sufficient amount to provide a visually observable color change”, followed by a list of such dyes including beta-carotene. A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that using a carotenoid for the dye would allow for a visually observable color change.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the swab sampling device with a color-changing indicator for determining pH of an oral sample disclosed in Jabbarzadeh with the carotenoid for the indicator color as taught by Hohlbein, creating a single sampling device for determining pH change of an oral sample using a carotenoid capable of attaining an observable color change.
Claims 13 – 15 are rejected under 35 U.S.C. 103 as being unpatentable over Jabbarzadeh et. al. (US 2020/0072756) in view of Seal et. al. (US 2021/0187128) and Perdido Bay Dental (“pH Balance and Your Teeth”; Reference U on PTO-892) and Prietto et. al. (“Ultrafine fibers of zein and anthocyanins as natural pH indicator”; Reference V on PTO-892) and Gathani (US Patent No. 5357989), further in view of Zuk, (United States Patent Application Publication US 2001/0017136 A1).
Regarding Claim 13, Jabbarzadeh in view of Seal, further in view of Perdido Bay Dental, further in view of Prietto, further in view of Gathani discloses as described above, The oral sampling device of claim 1. For the remainder of Claim 13, Jabbarzadeh does not disclose wherein the oral sampling support substrate (has a form factor of a dental aligner or a retainer.
Zuk teaches a molded bruxism appliance worn on the teeth with a pH indicator coating for detecting acid reflux with a color change. Specifically for Claim 13, Zuk teaches wherein the oral sampling support substrate (Fig 1, [0016] “spraying or painting the bruxism appliance with a composition; [0029] “the composition is provided with a pH indicator…provide the dentist with an indication…acid reflux”) has a form factor of a dental aligner ([0001] “bruxism appliance”; Fig 1)(Examiner notes that a bruxism appliance is worn on the teeth to align the teeth such that they do not grind their surfaces, and align the jaw such that the teeth do not grind.) or a retainer.
Jabbarzadeh and Zuk both use color-changing indicator agents coated on delivery mediums to determine pH of body tissues, Jabbarzadeh’s medium being a swab and Zuk’s medium being a U-shaped molded bruxism appliance that is worn on the teeth. Zuk provides a motivation to combine at [0029] with “the composition is provided with a pH indicator in order to provide the dentist with an indication of the degree of acid reflux by a patient during appliance use and in particular at night.” A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that coating the color-changing indicator on U-shaped molded bruxism appliance that is worn on the teeth would be useful for detecting nighttime reflux problems from acidic pH measurements in the subject’s nighttime-worn bruxism mouth appliance, alerting them to potential reflux disease.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the swab medium with a color-changing indicator for determining pH of an oral sample disclosed in Jabbarzadeh with Zuk’s taught U-shaped molded bruxism appliance that is worn on the teeth, creating a single oral pH sampling device that can be used as part of one’s regular nighttime bruxism mouth guard routine to help detect reflux disease.
Regarding Claim 14, Jabbarzadeh in view of Seal, further in view of Perdido Bay Dental, further in view of Prietto, further in view of Gathani discloses as described above, The oral sampling device of claim 13. For the remainder of Claim 14, Jabbarzadeh does not disclose wherein the dental aligner has a U-shaped base having an outer labial wall, an inner lingual wall, and an intervening tray floor, and wherein the dental aligner has one or more of the following properties: (i) wherein the bioresponsive interface is coated on an exterior surface of the outer labial wall, the inner lingual wall, or the intervening tray floor;
(ii) wherein the bioresponsive interface is coated on an interior surface of the outer labial wall, the inner lingual wall, or the intervening tray floor; and (iii) wherein the bioresponsive interface is intermixed within a body of the outer labial wall, the inner lingual wall, or the intervening tray floor.
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Fig A: Examiner-annotated version of Zuk Figure 1, showing the tray features and coating location.
Zuk teaches wherein the dental aligner ([0008] “a molded polymeric base for placement on a patient's upper or lower dentition”) has a U-shaped base (Figs 1 and 3) having an outer labial wall (Fig 1, [0021] “opposing teeth contacting surfaces”; Fig A: Examiner-annotated “outer labial wall”), an inner lingual wall (Fig 1, [0021] “opposing teeth contacting surfaces; Fig A: Examiner-annotated “inner lingual wall”),and an intervening tray floor (Fig 1, [0021] “opposing teeth contacting surfaces”; Fig A: Examiner-annotated “intervening tray floor”), and wherein the dental aligner ([0008] “molded polymeric base”) has one or more of the following properties:
(i) wherein the bioresponsive interface is coated on an exterior surface of the outer labial wall, the inner lingual wall, or the intervening tray floor;
(ii) wherein the bioresponsive interface is coated on an interior surface (Fig 1; [0021] “a coating is applied to the opposing teeth contacting surfaces of the appliance to a desired thickness by hand brushing, spray painting or dipping”) of the outer labial wall ([0021] “coating is applied…opposing teeth contacting surfaces of the appliance…”; Fig A: Examiner-annotated “outer labial wall”)(Examiner notes that the coating is on the surface that would touch the teeth, which is on the interior.), the inner lingual wall ([0021] “coating is applied…opposing teeth contacting surfaces of the appliance…”; Fig A: Examiner-annotated “inner lingual wall”)(Examiner notes that the coating is on the surface that would touch the teeth, which is on the interior), or the intervening tray floor ([0021] “coating is applied…opposing teeth contacting surfaces of the appliance…”; Fig A: Examiner-annotated “intervening tray floor”)(Examiner notes that the coating is on the surface that would touch the teeth, which is on the interior.), and
(iii) wherein the bioresponsive interface is intermixed within a body of the outer labial wall, the inner lingual wall, or the intervening tray floor.
The motivation for Claim 14 to combine Jabbarzadeh with Zuk is the same as that described in more detail in Claim 12. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the swab medium with a color-changing indicator for determining pH of an oral sample disclosed in Jabbarzadeh with Zuk’s taught U-shaped molded bruxism appliance that is worn on the teeth coated with color-changing indicator, creating a single oral pH sampling device that can be used as part of one’s regular nighttime bruxism mouth guard routine to help detect reflux disease.
Regarding Claim 15, Jabbarzadeh in view of Seal, further in view of Perdido Bay Dental, further in view of Prietto, further in view of Gathani discloses as described above, The oral sampling device of claim 14. For the remainder of Claim 15, Jabbarzadeh does not disclose wherein the intervening tray floor includes a positive mold of at least one of a subject's teeth.
Zuk teaches wherein the intervening tray floor (Fig 1, Fig 3; Fig A: Examiner-annotated “intervening tray floor”) includes a positive mold of at least one of a subject's teeth ([0008] “a molded polymeric base for placement on a patient’s upper or lower dentition”)(Examiner notes that the base is molded for a plurality of teeth on one jaw of a subject.).
The motivation for Claim 15 to combine Jabbarzadeh with Zuk is the same as that described in more detail in Claim 12. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the swab medium with a color-changing indicator for determining pH of an oral sample disclosed in Jabbarzadeh with Zuk’s taught U-shaped molded bruxism appliance that is worn on the teeth coated with color-changing indicator, creating a single oral pH sampling device that can be used as part of one’s regular nighttime bruxism mouth guard routine to help detect reflux disease.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Jabbarzadeh et. al. (US 2020/0072756) in view of Seal et. al. (US 2021/0187128) and Perdido Bay Dental (“pH Balance and Your Teeth”; Reference U on PTO-892) and Prietto et. al. (“Ultrafine fibers of zein and anthocyanins as natural pH indicator”; Reference V on PTO-892) and Gathani (US Patent No. 5357989), further in view of Li et. al., (United States Patent Application Publication US 2004/0220498 A1), hereinafter Li.
Regarding Claim 16, Jabbarzadeh in view of Seal, further in view of Perdido Bay Dental, further in view of Prietto, further in view of Gathani discloses as described above, The oral sampling device of claim 1. For the remainder of Claim 16, Jabbarzadeh does not disclose wherein the oral sampling device has a form factor of a lollipop, wherein the oral sampling support substrate is composed of an elongate stick and the bioresponsive interface has the a form of a hardened matrix mounted on the elongate stick.
Li teaches a lollipop-shaped oral platform for performing physiological tests, including pH changes using a color change indicator. Specifically for Claim 16, Li teaches wherein the oral sampling device has a form factor of a lollipop [0018] “laboratory in a lollipop”; Figure 1A and 1B, Fig 4 and 5), wherein the oral sampling support substrate is composed of an elongate stick ([0035] “a stick connected to the platform to serve as a handle”, Figs 1A, 4, and 5) and the bioresponsive interface has the a form of a hardened matrix ([0035] “a candy shell coating”; [0057] The reservoir 19 houses an absorbent material 21 that is pre-treated with a chemical indicator, such as pH indicator.”; Figs 1A, 4, and 5) mounted on the elongate stick (Figs 1A, 4, and 5).
Jabbarzadeh and Li both use color-changing indicator agents coated on delivery mediums to determine pH of body tissues, Jabbarzadeh’s medium being a swab and Li’s medium being a lollipop-shaped device. Li provides a motivation to combine at [0063] with “For disease diagnosis based on bodily fluids, the lollipop 20 will stimulate the saliva glands (or otherwise prepare the mouth), and stay in the mouth for a relatively long time, thus enabling it to make good chemical and biochemical assays (including tests for hormones, bacteria, virus, enzyme, DNA, antibody/antigen etc.) and physical measurements (including temperature, pH, Salinity, Viscosity, turbidity, etc.)” A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that coating the color-changing indicator on a lollipop-shaped device with candy coating would be useful for obtaining significant contact with saliva and a subject’s mouth for pH measurement to aid potential disease diagnosis.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the swab medium with a color-changing indicator for determining pH of an oral sample disclosed in Jabbarzadeh with Li’s taught lollipop-shape for the medium to carry the pH color indicator as taught by Li, creating a single oral pH sampling device that can be used to attain significant mouth and saliva contact for pH measurement to aid potential disease diagnosis.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Jabbarzadeh et. al. (US 2020/0072756) in view of Seal et. al. (US 2021/0187128) and Perdido Bay Dental (“pH Balance and Your Teeth”; Reference U on PTO-892) and Prietto et. al. (“Ultrafine fibers of zein and anthocyanins as natural pH indicator”; Reference V on PTO-892) and Gathani (US Patent No. 5357989), further in view of Buch et. al., (WO 96/29047), hereinafter Buch.
Regarding Claim 18, Jabbarzadeh in view of Seal, further in view of Perdido Bay Dental, further in view of Prietto, further in view of Gathani discloses as described above, The oral sampling device of claim 1. For the remainder of Claim 18, Jabbarzadeh does not disclose wherein the oral sampling device has a form factor of candy, wherein the oral sampling support substrate is composed of an edible matrix, and the bioresponsive interface is coupled to an exterior surface of the edible matrix or intermixed within the edible matrix.
Buch teaches color-changing systems for oral hygiene products, including hard candy lozenges, that change color with differing pH in the mouth. Specifically for Claim 18, Buch teaches wherein the oral sampling device ([Page 13, Lines 32 – 34] “solid delivery vehicles”; [Page 4, Lines 8 – 12] “the color-changing materials may be selected from a variety of materials…providing an initial color at a pH value of about 4 and a completion color, different from the initial color, at a pH value of about 7.”; [Page 14, Lines 1 – 5] “…color-changing compound…admixed with an appropriate buffer system to form a color-changing system, which may then be added to a suitable delivery vehicle base.”) has a form factor of candy ([Page 13, Lines 32 – 34] “Suitable solid delivery vehicles include lozenges, chewing gums, tablets, powders…”; [Page 18, Lines 19 – 20] “hard boiled candy lozenges”), wherein the oral sampling support substrate is composed of an edible matrix ([Page 14, Lines 1 – 5] “…color-changing compound…admixed with an appropriate buffer system to form a color-changing system, which may then be added to a suitable delivery vehicle base.”; [Page 18, Lines 19 – 20] “hard boiled candy lozenges), and the bioresponsive interface ([Page 14, Lines 1 – 5] “…color-changing compound…”) is coupled to an exterior surface of the edible matrix or intermixed within the edible matrix ([Page 14, Lines 1 – 5] “…color-changing compound…admixed with an appropriate buffer system to form a color-changing system, which may then be added to a suitable delivery vehicle base.”; [Page 18, Lines 19 – 20] “hard boiled candy lozenges.”)
Jabbarzadeh and Buch both use color-changing indicator agents coated on delivery mediums to determine pH of body tissues, Jabbarzadeh’s medium being a swab and Li’s medium being a hard candy lozenge. Buch provides a motivation to combine at [Page 3, Lines 24 – 36] including “the change in color of the product is an indication that the oral hygiene treatment has been provided to the oral cavity long enough to be effective…This durational indicator also aids users in achieving more effective oral hygiene.” And [Page 18, Lines 9 – 10] “Lozenges are intended to be convenient, portable solid dosage forms.” A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that coating the color-changing indicator on a hard candy lozenge would be useful for conveniently and portably addressing oral hygiene, receiving color-change feedback of the oral hygiene effort’s progress.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the swab medium with a color-changing indicator for determining pH of an oral sample disclosed in Jabbarzadeh with the hard candy lozenge for the medium to carry the pH color indicator as taught by Buch, creating a single oral pH sampling device that can be used conveniently and portably for oral hygiene purposes.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Jabbarzadeh et. al. (US 2020/0072756) in view of Seal et. al. (US 2021/0187128) and Perdido Bay Dental (“pH Balance and Your Teeth”; Reference U on PTO-892) and Prietto et. al. (“Ultrafine fibers of zein and anthocyanins as natural pH indicator”; Reference V on PTO-892) and Gathani (US Patent No. 5357989), further in view of Rubin, (United States Patent US 6,482,009 B1), hereinafter Rubin.
Regarding Claim 19, Jabbarzadeh in view of Seal, further in view of Perdido Bay Dental, further in view of Prietto, further in view of Gathani discloses as described above, The oral sampling device of claim 1. For the remainder of Claim 19, Jabbarzadeh does not disclose wherein the oral sampling device has a form factor of a paper point, wherein the oral sampling support substrate is composed of an absorbent material having a cylindrical body and at least one tapered end, wherein the bioresponsive interface is coupled to an exterior surface of the at least one tapered end.
Rubin teaches a paper point with a pH indicator at the tip for indicating if moisture is present with a particular pH in an area of the mouth during a root canal. Specifically for Claim 19, Rubin teaches wherein the oral sampling device has a form factor of a paper point (Fig 3, [Col 1, Lines 42 – 44] “paper points…small thin rod-like elements having a point at an end”; [Col 2, Lines 53 – 54] “a pH indicator is impregnated into the lower portion or apocal region of the paper point”), wherein the oral sampling support substrate ([Col 1, Lines 42 – 44] “paper point”) is composed of an absorbent material ([Col 1, Lines 42 – 44] “paper”) having a cylindrical body and at least one tapered end (Fig 3, [Col 1, Lines 42 – 44] “paper points…small thin rod-like elements having a point at an end”), wherein the bioresponsive interface is coupled to an exterior surface of the at least one tapered end ([Col 2, Lines 53 – 54] “a pH indicator is impregnated into the lower portion or apocal region of the paper point”)(Examiner notes that this will reach an exterior surface when the paper point is fully saturated with the impregnated substance).
Jabbarzadeh and Rubin both use color-changing indicator agents coated on delivery mediums to determine pH of body tissues, Jabbarzadeh’s medium being a swab and Rubin’s medium being paper point. Rubin provides a motivation to combine at [Col 1, Lines 38 – 40] ” paper points which are frequently used by dentists in an attempt to wipe the wall of the root canal, particularly at the lower depths thereof,” and [Col 3, Lines 14 – 17] “if the pH indicator shows either a positive or negative pH, this will provide very basic information to the dentist or other dental practitioner as to possible types of bacterial growth which may be present.” A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize that adding the color-changing indicator to a paper point would be useful for dental professionals to assess root canal moisture and bacteria conditions during procedures, with clear color-change indicator information.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the swab medium with a color-changing indicator for determining pH of an oral sample disclosed in Jabbarzadeh with the paper point for the medium to carry the pH color indicator as taught by Rubin, creating a single oral pH sampling device that can be used to inspect moisture conditions in the mouth for root canal procedures.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Erickson et. al., (United States Patent Application Publication US 2016/0080548 A1) in view of Seal, further in view of Perdido Bay Dental, further in view of Prietto.
Regarding Claim 22, Erickson discloses A system for analyzing a bioresponsive interface ([Abstract]; [0028] “a disposable test strip wherein the indicia of the analyte is one of pH”; Fig 3A) the system comprising:
An oral sampling device ([0030] – [0031] “a disposable test strip wherein the indicia of the analyte is one of pH”) comprising a bioresponsive interface ([0115] ”a test strip containing a pH indicator region…”;[0028] “a disposable test strip wherein the indicia of the analyte is one of pH”; [0030] – [0031] “a disposable test strip wherein the indicia of the analyte is one of pH”; Fig 3A; [0109] “a salivary monitoring interface”), and a pH sensing agent ([0115] ”a test strip containing a pH indicator region…”), wherein the bioresponsive interface undergoes a color change in response to a pH change ([0022] “term ‘colorimetric test,’ ‘colorimetric assay,’ or ‘colorimetric reactive test platform’…means at least a measurable color change from one color to a different color…in the presence of the analyte.”; [0132] “image the colorimetric test strip and determine the pH of the sample”) in the oral cavity (Fig 3A; [0113] “a colorimetric reaction to occur when a sample of…saliva…is applied.)(Examiner notes that a sample of saliva is associated with the broad-spectrum region of all of the inside the oral cavity.);
a memory containing a non-transitory computer readable medium comprising machine executable code ([0082] “an executable application resident in the smartphone”)(Examiner notes that a smartphone would store an application in a memory.) having stored instructions thereon for performing a method of analyzing the bioresponsive interface ([0131] “smartphone's camera and a resident smartphone application is used to obtain quantitative pH and sodium concentration values.”; [0019] “mobile apparatus that is capable of running a programmed application suitable for executing the embodied functionality”; [0082])(Examiner notes that that application contains the instructions for performing the method.);
a camera ([0131] “smartphone’s camera”) configured to photograph a region of interest on the oral sampling device ([0028] “colorimetric reactive test platform having a test region and a calibration region…obtaining a color image of the test region containing the analyte and the calibration region”; [0131] “test strip with the pH indicator paper facing the smartphone camera…”, [0132] “the smartphone camera takes a photograph of the strip for image processing”) and
a computer in electrical communication with the memory ([0019] “mobile apparatus that is capable of running a programmed application suitable for executing the embodied functionality”)(Examiner notes that a smartphone contains a processor to serve as a control system to execute applications, and the processor would be in electrical communication with the memory.), the computer configured to execute the machine executable code ([0019] “mobile apparatus that is capable of running a programmed application suitable for executing the embodied functionality”)(Examiner notes that a smartphone contains a processor to serve as a control system to execute applications, and the processor would be in electrical communication with the memory.; [0131] “…a resident smartphone application…”), to cause the computer to:
determine a pH of the region of interest on the oral sampling device based on a color of the region of interest (Fig 1, Steps from “Extract 256 x 256 pixel array RGB values” to “adjust HSL to pH calibration curve”; Fig 3A, 3B, 3C; [0028] - [0036] “…obtaining a point-of-collection, selected quantitative indicia of an analyte on a test platform with a smartphone”, [0031] “wherein the indicia of the analyte is one of pH…”); and
output a report that includes the pH of the region of interest ([Fig 1, “Display Result onscreen”; [0036] “displaying the determined selected quantitative indicia of the analyte on the smartphone”; [0031] “analyte…is pH”; Fig 3A, 3B, 3C)(Examiner notes that displaying the pH result on the smartphone screen is communicating a visual report.)
Erickson does not disclose for identification of demineralization in an oral cavity of a subject; the bioresponsive interface comprising silk fibroin, wherein the pH sensing agent is present in the bioresponsive interface at a concentration in a range of 5% to 50% weight/volume, wherein the concentration is based on a total volume of the bioresponsive interface, and wherein a pH of 5.5. or less indicates demineralization in the oral cavity of the subject;
Seal teaches an electrospun nanofibrous silk fibroin mat infused with a reactive oxygen species (ROS) detection reagent to detect environmental changes at a wound site. Specifically for Claim 22, Seal teaches the biopolymeric matrix comprising silk fibroin ([0115] “nanofibrous silk fibroin mats were infused with Amplex red dye for a real-time sensing of the oxidative stress in the wounds…”; [0012] “degree of color change in the electrospun nanofibrous mat to a control to measure an amount of ROS at the wound site of the patient.”; [Abstract] “reactive oxygen species”; [0020] “Electrospinning of the silk fibroin solution leads into the formation of nanofibrous silk fibroin mats.”; [0074])
Erickson and Seal both use color-changing indicator agents to determine changes in an environmental parameter of body tissues, Erickson with [0020] “Practical examples of embodied modular test platforms include, but are not limited to, various custom or commercially available 'test strips,” that color change to detect pH, and Seal’s biopolymeric matrix electrospun fibroin mat with polyethylene oxide (PEO) with a color changing indicator responding to reactive oxygen species environment changes at wounds. Seal provides a motivation to combine at [0074] “The silk fibroin mats were electrospun from the silk fibroin solution blended with polyethylene oxide (PEO), which is also a biocompatible polymer” A person having ordinary skill in the art before the effective filing data of the claimed invention would recognize coating the color-changing indicator on silk fibroin would be useful for detecting environmental change issues associated with the body or particularly at wound sites, as it is biocompatible with open sores.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the test strip to test body tissues with color changing pH indicator to be read by a smartphone application disclosed by Erickson with the silk fibroin for the medium to carry the pH color indicator as taught by Seal, creating a single oral pH sampling device that can be used close to wound sites for determining environmental changes in the area with visual color change indication.
Seal does not teach for identification of demineralization in an oral cavity of a subject; wherein the pH sensing agent is present in the bioresponsive interface at a concentration in a range of 5% to 50% weight/volume, wherein the concentration is based on a total volume of the bioresponsive interface, and wherein a pH of 5.5 or less indicates demineralization in the oral cavity of the subject;
Perdido Bay Dental teaches that a healthy mouth has a neutral pH, and that at a pH of 5.5, teeth begin to demineralize. Specifically for Claim 22, Perdido Bay Dental teaches for identification of demineralization ([Page 1, “The pH Range and Your Mouth” Section, Paragraph 1] “At a pH of 5.5 the teeth begin to demineralize, putting them at risk for cavities.”) and wherein a pH of 5.5 or less indicates demineralization in the oral cavity of the subject ([Page 1, “The pH Range and Your Mouth” Section, Paragraph 1] “At a pH of 5.5 the teeth begin to demineralize…A healthy mouth is in the neutral pH range”, [Page 1, Paragraph 2] “pH value of 7 is neutral”).
Erickson indicates at Figure 10B that it can indicate and measure a pH of 5.5, with the line between 3 – 9 pH. Perdido Bay Dental provides a motivation to combine at [Page 1, “The pH Range and Your Mouth” Section, Paragraph 1] with “At a pH of 5.5 the teeth begin to demineralize, putting them at risk for cavities.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that setting a pH of 5.5 as a notable threshold for observation of an oral pH measurement device result would be useful for determining if there possible tooth demineralization present that could lead to cavities.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the test strip to test body tissues with color changing pH indicator (that can read 5.5 pH) to be read by a smartphone application disclosed by Erickson with the pH of 5.5 threshold for tooth demineralization taught by Perdido Bay Dental, creating a single oral pH sampling device that can be used to evaluate oral pH consistent with the possibility of tooth demineralization and cavity formation.
Perdido Bay Dental does not teach wherein the pH sensing agent is present in the bioresponsive interface at a concentration in a range of 5% to 50% weight/volume, wherein the concentration is based on a total volume of the bioresponsive interface.
Prietto teaches pH sensitive indicator membranes used for pharmaceutical, food, and packaging applications, incorporating zein fiber(protein extracted from corn [Page 2735, Left column, Paragraph 3]) and 5% (w/v) anthocyanins indicators [Abstract]. Specifically for Claim 22, Mirani teaches wherein the pH sensing agent is present in the bioresponsive interface at a concentration in a range of 5% to 50% weight/volume ([Page 2740, Right Column, 2nd Full Paragraph] “Zein solutions at 30% (w/v) polymer concentration, containing 3%, 4% or 5% (w/v) anthocyanins… ultrafine fibers with anthocyanins exhibited vivid color changes depending on pH…”; [Abstract]), wherein the concentration is based on a total volume of the bioresponsive interface [Page 2740, Right Column, 2nd Full Paragraph] “Zein solutions at 30% (w/v) polymer concentration, containing 3%, 4% or 5% (w/v) anthocyanins.”; [Abstract])
Prietto provides a motivation to combine at [Page 2738, Right Column, 1st Full paragraph] with “… increasing red color intensity as the anthocyanin content within the ultrafine fibers increased from 3% to 5% (Fig. 2B, C, D).”; [Page 2739, Left Column, Paragraph 2] “The increase of anthocyanin concentration in the membranes of 3% (Fig. 3B) to 5% (Fig. 3D) resulted in a greater variation in color under different pH conditions.”; and [Page 2735, Right Column] “…naturally occurring food-grade materials…” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that increasing the concentration of an anthocyanin indicator on biomaterial to at least 5% would be useful for more vibrant pH indication using a food-safe indicator material.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the test strip to test body tissues with color changing pH indicator to be read by a smartphone application disclosed by Erickson with the food safe 5% concentration of anthocyanin pH indicator dye on its interface medium taught by Prietto, creating a single oral pH sampling device that can have vibrant color changing to indicate pH using naturally-occurring, food-grade anthocyanin dye material.
Response to Arguments
Applicant's arguments filed 02 JANUARY 2026 have been fully considered but they are not persuasive.
Regarding 35 U.S.C. 101 Rejections:
Applicant argues at [Page 6, Bottom] – [Page 9 “Mental Process” Section] that Claim 22 does not recite an abstract idea, as it cannot be practically performed in the human mind without use of the recited aid, such as determining a pH of a region of interest on an oral sampling device based on color, where the oral sampling device is silk fibroin and has a pH sensing agent coated thereon. As recited, broadly “determining a pH of a region of interest on an oral sampling device based on color” is the routinely manual task in which a human observes a difference in the color on a pH indicator strip (or object with pH indicator thereon), visually compares it to the color key for the indicator, and determines the pH based on the color on the color key visual reference. The argument is not persuasive.
Applicant argues at [Page 10, 1st Full Paragraph] – [Page 11, 2nd Paragraph] that the embodiments of amended claim 22 improve the salivary diagnostic arts by enabling analytical computation of low concentrations (pg-ng per µL) and dynamic levels of biomarkers intra and inter-individuals. There is nothing particularly recited in the claim that indicates that there is analytical computation of low concentrations of biomarkers. As recited (and discussed above), “determining a pH of a region of interest on the oral sampling device…” is the routinely manual task in which a human determines a pH result based on a visually observed color change on a color change strip (or object with pH indicator thereon) and a reference key. The argument is not persuasive.
Applicant argues at [Page 11, “Step 2B” Section] – [Page 12, end of claim recitation] that the recitations from amended independent claim 22 are not individually or collectively generic computer functions. The abstract ideas recited, including “determine a pH of the region of interest on the oral sampling device based on a color of the region of interest” and “output a report that includes the pH of the region of interest” can be, for example, routinely manual tasks in which a human determines a pH result based on a visually observed color change on a color change strip (or object with pH indicator thereon) and a reference key, then writes the numeric result on a sheet of paper to communicate to another person. There is nothing particular recited that the computer is performing an unusual function. Further, as recited, “determine a pH of the region of interest” by a computer could be receiving the numeric input of the pH result into a document from a human who has visually observed the color change, the “output a report” could be printing said report. Both of which are routine functions of a computer, such that the recited limitations do not improve a computer itself. From MPEP 2106.05(a): It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). The argument is not persuasive.
Applicant summarily argues at [Page 12, 6th and 7th Full Paragraphs] that independent claim 22 is patent eligible and that the 35 U.S.C. 101 rejection should be withdrawn. Based on the 35 U.S.C 101 analysis herein and the discussion of arguments above, Claim 22 does not qualify as eligible subject matter under 35 U.S.C. 101. The argument is not persuasive.
Regarding 35 U.S.C. 102 Rejections:
Applicant’s argues at [Page 12, “Claim Rejections – 35 USC 102” Section] that Jabbarzadeh does not disclose the limitations of amended claim 1. Based on the amendments to the claim, Jabbarzadeh has been combined with Seal, Perdido Bay Dental, Prietto, and Gathani to disclose the limitation s of amended claim 1 for a 35 U.S.C. 103 rejection. The 35 U.S.C. 102 rejection for claims 1 – 4, 6 – 7, and 9 – 11 is withdrawn.
Applicant’s argues at [Page 13, Paragraphs 1 - 2] that Erickson does not disclose the limitations of amended claim 22. Based on the amendments to the claim, Erickson has been combined with Seal, Perdido Bay Dental, and Prietto to disclose the limitation s of amended claim 22 for a 35 U.S.C. 103 rejection. The 35 U.S.C. 102 rejection for claim 22 is withdrawn.
Regarding 35 U.S.C. 103 Rejections:
Applicant argues at [Page 13, Paragraph 3 - 4] that Hohlbein, Seal, Gathani, Zuk, Li, Buch, or Rubin, taken alone or in combination fail to cure the deficiencies of Jabbarzadeh with respect to claim 1. Based on the 35 U.S.C. 103 rejection above, Jabbarzadeh has been combined with Seal, Perdido Bay Dental, Prietto, and Gathani to disclose the limitations of amended claim 1. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The argument is not persuasive.
Applicant summarily argues at [Page 13, Paragraph 4] that as claims 5 and 12 – 19 depend from an allowable claim 1, they are also allowable. Based on the 35 U.S.C. 103 rejection and the discussion of arguments above, amended Claim 1 is not allowable. The argument is not persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA J MONTGOMERY whose telephone number is (571)272-2305. The examiner can normally be reached Monday - Friday 7:30 - 5:00 ET.
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/MELISSA JO MONTGOMERY/ Examiner, Art Unit 3791
/PATRICK FERNANDES/ Primary Examiner, Art Unit 3791