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 .
Status of Claims
This action is in reply to the current action filed on 7/24/2024.
Claims 1-21 are currently pending and have been examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7/24/2024 was filed after the mailing date of the first action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 3-5, 7-8, 16-18, and 20 are objected to for the following informalities:
Claims 3-4 state “wherein diagnosing the vaginal disorder comprising”. It should state “comprises”.
Claim 5 states “wherein said computing element comprising”. It should state “comprises”.
Claim 7 states “wherein said primary data comprising pH”. It should state “comprises”.
Claim 8 states “wherein further comprising collecting”. It should state “further comprising collecting”.
Claim 16 states “wherein said database further comprising”. It should state “comprises”.
Claim 17 states “wherein diagnosing the vaginal disorder comprising”. It should state “comprises”.
Claim 18 states “wherein the processor further comprising”. It should state “comprises”.
Claim 20 states “wherein said primary data comprising pH”. It should state “comprises”.
Claim Rejections - 35 USC § 112(b)
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 1-13 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 states “determining a likelihood of the subject diagnosed with the vaginal disorder based on the data processed and if the subject is diagnosed with the vaginal disorder, recommending one or more treatment options.” It is unclear what the “likelihood” of this limitation is a likelihood of, and the limitation has grammatical errors making it difficult to understand the meaning. For the purposes of compact prosecution, Examiner will interpret the claim as “determining a likelihood of the subject being diagnosed with the vaginal disorder based on the data processed, and, if the subject is diagnosed with the vaginal disorder, recommending one or more treatment options”.
Claims 2-13 are further rejected as being dependent upon a rejected claim.
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.
Claims 1-21 are rejected under 35 USC § 101 as being directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1 Analysis:
Independent Claims 1 and 14 are within the four statutory categories. Claims 1 and 14 are drawn to a method and a system, respectively. Dependent Claims 2-13 are also directed to a method and Claims 15-21 are directed to a system. Therefore, the dependent claims also fall into one of the four statutory categories.
Step 2A Analysis- Prong One:
Claim 1, which is representative of the inventive concept, recites the following:
A method for diagnosing a vaginal disorder in a subject, comprising:
collecting primary data obtained from a device for diagnosing the vaginal disorder;
storing the primary data in a database;
sending the primary data to a processor, said processor is configured to run a plurality of modules comprising an at least one diagnosis module and a treatment module and to process the primary data;
and determining a likelihood of the subject diagnosed with the vaginal disorder based on the data processed and if the subject is diagnosed with the vaginal disorder, recommending one or more treatment options.
The limitations as shown in underline above, given the broadest reasonable interpretation, cover the abstract idea of certain methods of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions, and/or mental process that a neurologist should follow when testing a patient for nervous system malfunctions- in this case, collecting data, determining the likelihood of a subject diagnoses with a vaginal disorder, and recommending treatment options), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements” and will be discussed in further detail below.
Dependent Claims 2-4, 6-13, 15-17, and 19-20 include other limitations directed to the abstract idea. For example, Claim 2 recites collecting secondary data, Claim 3 recites diagnosing candidiasis, bacterial vaginosis and trichomoniasis or vaginitis, Claim 4 recites diagnosing the vaginal disorder comprising diagnosing vulvar conditions, Claims 6 and 19 recite determining the likelihood of a subject diagnosed with a vaginal disorder based on a probability score, Claims 7 and 20 recite what the primary data comprises, Claim 8 recites what the secondary data comprises, Claim 9 recites if the sialidase test is positive, what conditions the subject is experiencing, Claim 10 recites if the pH is greater than 4.5, recommending a trichomonas antigen test, Claim 11 recites if the trichomonas antigen test is negative, the subject is asked what conditions the subject may be experiencing, Claim 12 recites if the trichomonas antigen test is negative, the one or more images are analyzed, Claim 13 recites if the candida antigen test is negative and the pH is less than 4.5, the one or more images are analyzed to confirm presence of Candida organism, Claim 15 recites collecting and sampling vaginal discharge or fluid, Claim 16 recites secondary data comprises structured data and non-structured data, Claim 17 recites what conditions diagnosing the vaginal disorder entails. These limitations only server to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g., see MPEP 2106.04. Additionally, any limitations in the dependent claims not addressed above are deemed additional elements to the abstract idea and will be further addressed below. Hence dependent Claims 2-4, 6-13, 15-17, and 19-20 are nonetheless directed towards fundamentally the same abstract idea as independent Claims 1 and 14.
Step 2A Analysis- Prong Two:
Claims 1 and 14 are not integrated into practical application because the additional elements (i.e. the non-underlined limitations above – in this case, the device, database, processor, diagnosis module, and treatment module of Claims 1 and 14) are recited at a high level of generality (i.e. as a generic processor performing generic computer functions) such that they amount to no more than mere instructions to apply an exception using generic computer parts. For example, Applicant’s specification explains that the system described in the present disclosure may further include one or more databases (DB) 13 for storing data… the one or more databases (DB) 13 may use OracleTM, SQLTM AccumoloTM or a similar software (Applicant’s specification, p. 5-6, lines 30-34, 1-2). The processor mentioned above including the CPUs, is configured to process the data (including primary and / or secondary data). In some embodiments, the processor is also configured to run a plurality of modules (p. 6, lines 2-4). The plurality of modules comprises at least a diagnosis module and a treatment module, for providing the likelihood of the vulvo-vaginal disorder in the subject based on the data processed (p. 6, lines 8-10). MPEP 2106.04(d)(1) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Furthermore, Claims 1 and 14 recite the additional element of a device. The device merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(1) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. For example, Applicant’s specification explains that the device for analyzing the sample may comprise a collection apparatus for collecting and sampling vaginal discharge or fluid and a sensor for processing the sampling vaginal discharge or fluid, said sensor comprising at least two lateral flow assays (LFAs) (Applicant’s specification, p. 4, lines 1-3). Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on the abstract idea. Therefore, Claims 1 and 14 are directed to an abstract idea without practical application.
Dependent Claims 2, 5-6, 12-13, 15-16, 18-19, and 21 recite additional elements, but these limitations amount to no more than mere instructions to apply an exception. Claim 2 recites the previously recited additional element of the processor and specifies sending secondary data to the processor to process the data, Claims 5 and 18 recite the previously recited processor, diagnosis module, and treatment module and new additional elements of a computing element and machine learning module and specifies the processor comprises a computing element and machine learning module and further, the computing element comprises the diagnosis and treatment module, Claims 6 and 19 recite the previously recited computing element and specifies the computing element determines the likelihood of the subject being diagnoses with the vaginal disorder based on a probability score, Claim 12 recites a new additional element of an image analysis module and specifies the images are analyzed by the image analysis module, Claim 13 recites a new additional element of an image analysis module and specifies the images are analyzed by the image analysis module to confirm presence of Candida organism, Claim 15 recites the previously recited device and new additional elements of a collection apparatus and a sensor and specifies the device comprises a collection apparatus for collecting and sampling discharge/fluid and a sensor comprising lateral flow assays, Claim 16 recites the previously recited database and specifies it comprises secondary data, Claim 21 recites a new additional element of an amine sensor. However, these additional elements are described only at a high level of generality and are being used in their expected fashion, so these additional elements do not integrate the abstract idea into a practice application because they do not impose any meaningful limits on the abstract idea. The claims do not recite additional elements that integrate the judicial exception into a practical application when considered both individually and as an ordered combination.
Step 2B Analysis:
The claims, when considered individually or in combination, do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as discussed with respect to step 2A prong two, the additional elements of the device, database, processor, diagnosis module, and treatment module of Claims 1 and 14 amount to mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”) in step 2B. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). MPEP2106.05(I)(A) indicates that merely saying "apply it” or equivalent to the abstract idea cannot provide an inventive concept ("significantly more"). Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional element of the device was considered to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the ‘significantly more’ analysis and has been found insufficient to provide significantly more. MPEP2106.05 (A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide an inventive concept (‘significantly more"). Accordingly, even in combination, the additional elements do not provide significantly more. For these reasons, independent Claims 1 and 14 are not patent eligible.
Dependent Claims 3-4, 7-11, 17, and 20 do not recite any additional elements and merely narrow the abstract idea. Claim 3 narrows the abstract idea by specifying diagnosing candidiasis, bacterial vaginosis and trichomoniasis or vaginitis, Claim 4 narrows the abstract idea by specifying diagnosing the vaginal disorder comprising diagnosing vulvar conditions, Claims 7 and 20 narrows the abstract idea by specifying what the primary data comprises, Claim 8 narrows the abstract idea by specifying what the secondary data comprises, Claim 9 recites if the sialidase test is positive, what conditions the subject is experiencing, Claim 10 narrows the abstract idea by specifying if the pH is greater than 4.5, the subject is recommended to undergo a trichomonas antigen test, Claim 11 narrows the abstract idea by specifying if the trichomonas antigen test is negative, the subject is asked what conditions the subject may be experiencing, Claim 17 narrows the abstract idea by specifying what conditions diagnosing the vaginal disorder entails.
Dependent Claims 2, 6, 16, and 19 recite previously cited additional elements, which are not eligible for the reasons stated above, and further narrow the abstract idea. Claim 2 recites the previously recited additional element of the processor and specifies sending secondary data to the processor to process the data, Claims 6 and 19 recite the previously recited computing element and specifies the computing element determines the likelihood of the subject being diagnoses with the vaginal disorder based on a probability score, Claim 16 recites the previously recited database and specifies it comprises secondary data.
Dependent Claims 5, 12-13, 15, 18, and 21 recite new additional elements. Claims 5 and 18 recite the previously recited processor, diagnosis module, and treatment module and new additional elements of a computing element and machine learning module and specifies the processor comprises a computing element and machine learning module and further, the computing element comprises the diagnosis and treatment module, Claim 12 recites a new additional element of an image analysis module and specifies the images are analyzed by the image analysis module, Claim 13 recites a new additional element of an image analysis module and specifies the images are analyzed by the image analysis module to confirm presence of Candida organism, Claim 15 recites the previously recited device and new additional elements of a collection apparatus and a sensor and specifies the device comprises a collection apparatus for collecting and sampling discharge/fluid and a sensor comprising lateral flow assays, Claim 21 recites a new additional element of an amine sensor.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination does not add anything that is already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, Claims 1-21 are rejected under 35 U.S.C. 101 as being directed to a non-statutory subject matter.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-6, 14, 16, and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Apte et al. (US 20170002432 A1).
Regarding Claim 1, Apte discloses the following:
A method for diagnosing a vaginal disorder in a subject, comprising: collecting primary data obtained from a device for diagnosing the vaginal disorder; (Apte discloses a method 100 for diagnostic testing includes: providing a sampling kit to a subject, the sampling kit including a sample container for reception of a sample from a collection site of the subject S110; receiving the sample from the subject S120; generating a microbiome composition dataset based upon sequencing nucleic acid content of a microorganism portion of the sample S130; detecting a presence of at least one of a set of microbiome targets and a set of targets associated with sexually transmitted diseases (STDs) S140; [0013]. The method 100 can additionally, …test a sample for condition-associated prokaryotic organisms including: …Gardnerella vaginalis (associated with Vaginitis),…[0016]. The Examiner interprets Vaginitis as a vaginal disorder.)
storing the primary data in a database; (Apte discloses the system 200 …can additionally or alternatively include or communicate data to and/or from: a user database (storing user account information, user microbiome information, user profiles, user health records, user demographic information, associated care provider information, associated guardian information, user device information, etc.), an analysis database (storing computational models, collected data, historical data, public data, simulated data, generated datasets, generated analyses, diagnostic results, therapy recommendations, etc.), and/or any other suitable computing system [0096].)
sending the primary data to a processor, said processor is configured to run a plurality of modules comprising an at least one diagnosis module and a treatment module and to process the primary data; (Apte discloses device components used with the method 100 can include an input (e.g., keyboard, touchscreen, etc.), an output (e.g., a display), a processor, a transceiver, and/or any other suitable component, wherein data from the input device(s) and/or output device(s) can be generated, analyzed, and/or transmitted to entities for consumption (e.g., for a user to assess their diagnostic results, microbiome insights, and/or therapy recommendations) [0098]. In relation to the sample processing module, the module can function to process a collected sample into a form suitable for sequencing and/or analysis in generating diagnostic results, microbiome insights, and/or a recommended therapy [0101].)
and determining a likelihood of the subject being diagnosed with the vaginal disorder based on the data processed, (Apte discloses the generated analysis can include verbal, numerical, graphical, audio, and/or any suitable format of information associated with: disease or a disease panel (e.g., a risk value for a disease in the form of a probability of a positive diagnosis for an STD, etc.)…[0068]. Generating a diagnostic analysis for a plurality of STDs can include…generating, for the individual, a positive diagnosis risk value for the STD of the plurality of STDs based on the comparison, wherein presenting information derived from the diagnostic analysis (e.g., as in Block S170) comprises presenting the positive diagnosis risk value [0070].)
and, if the subject is diagnosed with the vaginal disorder, recommending one or more treatment options. (Apte discloses the diagnostic analysis is informative of microbiome aspects of the sample and assessment of STD presence associated with the sample S150; generating a therapy recommendation based on the set of microbiome targets S160; and promoting the therapy recommendation in coordination with presenting information derived from the diagnostic analysis S170 [0013]. Generating an analysis can be derived from, determined by, and/or based on one or more of:…models (e.g., models incorporating probabilistic properties, heuristic properties, deterministic properties, and/or any other suitable properties),…The generated analysis can include… numerical, graphical, audio, and/or any suitable format of information associated with: disease or a disease panel (e.g., a risk value for a disease in the form of a probability of a positive diagnosis for an STD, etc),… [0068].)
Regarding Claim 14, this claim recites limitations that are substantially similar to those recited in Claim 1 above; thus, the same rejection applies. Apte further discloses:
A system for diagnosing a vaginal disorder in a subject, (Apte discloses a system 200, as shown in FIG. 1B, including a sample handling network…; a sample processing module, in communication with the sample handling network,...and a computing system configured to generate and provide analyses derived from processing of the samples, in support of diagnostic tests of the received samples [0017].)
Regarding Claim 2, Apte discloses the limitations as seen in the rejection of Claim 1 above. Apte further discloses the following:
further comprising collecting secondary data, said secondary data comprising structured data and non-structured data and sending the secondary data to the processor for processing said secondary data. (Apte discloses FIGS. 1A and 1C, Block S130 can additionally or alternatively include ranking a set of candidate primers according to at least one selected primer feature or target feature S132, which functions to select desired characteristics for one or more primers and/or targets for use in processing a collected sample to generate a microbiome sequence dataset. With respect to Block S132, ranking a set of candidate primers can be determined…based on various criteria, including one or more of:…user demographic (e.g., age, ethnicity, geographical locale, etc.), received user responses to surveys (e.g., surveys presented through an application executing on a mobile, a survey included in the sampling kit, an initial screening survey prior to provision of the survey kit, etc.), and/or any other suitable criteria [0042-43]. The microbiome sequence dataset is interpreted as structured data, and the demographic/survey data is interpreted as non-structured data.)
Regarding Claim 3, Apte discloses the limitations as seen in the rejection of Claim 1 above. Apte further discloses the following:
wherein diagnosing the vaginal disorder comprising diagnosing candidiasis, bacterial vaginosis and trichomoniasis or vaginitis. (Apte discloses the method 100 can additionally, simultaneously and/or contemporaneously test a sample for condition-associated prokaryotic organisms including:… Gardnerella vaginalis (associated with Vaginitis),…additionally, simultaneously and/or contemporaneously test a sample for condition-associated eukaryotic organisms including Trichomonas vaginalis (associated with Trichomoniasis)…[0016].)
Regarding Claim 5, Apte discloses the limitations as seen in the rejection of Claim 1 above. Apte further discloses the following:
wherein the processor further comprising a computing element and a machine learning module, (Apte discloses in another variation of Block S160, generating a therapy recommendation can include automatically generating a therapy recommendation … For example, therapy recommendations can be generated using a machine learning classifier with features derived from a microbiome sequenced dataset, a detected set of microbiome targets, a diagnostic analysis, user survey responses, and/or any suitable information [0081, Fig. 7].)
and wherein said computing element comprising the at least one diagnosis module and one treatment module. (Apte discloses device components used with the method 100 can include …a processor, a transceiver, and/or any other suitable component, wherein data from the input device(s) and/or output device(s) can be generated, analyzed, and/or transmitted to entities for consumption (e.g., for a user to assess their diagnostic results, microbiome insights, and/or therapy recommendations) [0098]. In relation to the sample processing module, the module can function to process a collected sample into a form suitable for sequencing and/or analysis in generating diagnostic results, microbiome insights, and/or a recommended therapy [0101].)
Regarding Claim 18, this claim recites limitations that are substantially similar to those recited in Claim 5 above; thus, the same rejection applies.
Regarding Claim 6, Apte discloses the limitations as seen in the rejection of Claim 1 above. Apte further discloses the following:
wherein determining the likelihood of the subject diagnosed with the vaginal disorder is based on a probability score generated by the computing element. (Apte discloses the generated analysis can include verbal, numerical, graphical, audio, and/or any suitable format of information associated with: disease or a disease panel (e.g., a risk value for a disease in the form of a probability of a positive diagnosis for an STD, etc.) [0068].)
Regarding Claim 19, this claim recites limitations that are substantially similar to those recited in Claim 6 above; thus, the same rejection applies.
Regarding Claim 16, Apte discloses the limitations as seen in the rejection of Claim 14 above. Apte further discloses the following:
wherein said database further comprising secondary data, said secondary data comprising structured data and non-structured data. (Apte discloses FIGS. 1A and 1C, Block S130 can additionally or alternatively include ranking a set of candidate primers according to at least one selected primer feature or target feature S132, which functions to select desired characteristics for one or more primers and/or targets for use in processing a collected sample to generate a microbiome sequence dataset. With respect to Block S132, ranking a set of candidate primers can be determined…based on various criteria, including one or more of:…user demographic (e.g., age, ethnicity, geographical locale, etc.), received user responses to surveys (e.g., surveys presented through an application executing on a mobile, a survey included in the sampling kit, an initial screening survey prior to provision of the survey kit, etc.), and/or any other suitable criteria [0042-43]. The microbiome sequence dataset is interpreted as structured data, and the demographic/survey data is interpreted as non-structured data.)
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.
Claims 4, 7-10, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Apte et al. (US 20170002432 A1) in view of Brown et al. (Brown et al. “Improving the Diagnosis of Vulvovaginitis: Perspectives to Align Practice, Guidelines, and Awareness.” Population health management vol. 23,S1 (2020)).
Regarding Claim 4, Apte discloses the limitations as seen in the rejection of Claim 1 above. Apte does not disclose the following limitation met by Brown:
wherein diagnosing the vaginal disorder comprising diagnosing vulvar conditions (Brown teaches current ACOG guidelines, which acknowledge that appropriate office-based tools may not always be available, allow for the use of commercial tests that have been approved by the FDA for the diagnosis of vulvovaginitis in such circumstances. Payer policies for vulvovaginitis must similarly evolve to cover the use of these tests, reducing any cost burden to patients (p. 6, ¶ 0001). The Examiner interprets vulvovaginitis as a vulvar condition.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for collecting data, processing the data, determining the likelihood of a vaginal disorder diagnosis, and recommending treatment options as disclosed by Apte to incorporate the diagnosing being for a vulvar condition as taught by Brown. This modification would create a system and method capable of improving diagnosis of vulvar conditions to provide effective treatment (see Brown, abstract).
Regarding Claim 7, Apte discloses the limitations as seen in the rejection of Claim 1 above. Apte does not disclose the following limitation met by Brown:
wherein said primary data comprising pH, result of candida antigen test, result of sialidase activity test, result of DNA or RNA test, one or more images obtained from the subject and combination thereof. (Brown teaches the diagnosis is based on the presence of the following 4 Amsel criteria: 1. Discharge: homogeneous, thin, white-gray discharge that smoothly coats the vaginal walls 2. Clue cells: more than 20% clue cells on saline microscopy 3. pH >4.5: vaginal fluid pH >4.5 4. Positive KOH: positive KOH whiff test result (p. 2, ¶ 0010). Paladine has noted that newer laboratory tests such as DNA and antigen testing for BV and VVC, or vaginal fluid sialidase testing for BV, may have similar or better sensitivity and specificity compared with traditional office-based testing (p. 4, ¶ 0010).)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for collecting data, processing the data, determining the likelihood of a vaginal disorder diagnosis, and recommending treatment options as disclosed by Apte to incorporate the data being pH data, sialidase test results, and DNA tests as taught by Brown. This modification would create a system and method capable of improving diagnosis of vaginal disorders to provide effective treatment (see Brown, abstract).
Regarding Claim 20, this claim recites limitations that are substantially similar to those recited in Claim 7 above; thus, the same rejection applies.
Regarding Claim 8, Apte and Brown teach the limitations as seen in the rejection of Claim 7 above. Apte further discloses:
wherein further comprising collecting secondary data, said secondary data comprising asking the subject is experiencing… (Apte discloses a subject can order a sampling kit through an electronic (e.g., online) ordering system, whereby the subject completes an initial screening survey that asks for age information and sexual activity status (e.g., “are you sexually active?”). Upon completion of the survey, the subject can then be directed to provide information required for completion of the order [0030].)
Apte does not disclose the questions including one of the following conditions which met by Brown:
at least one of the following conditions: external vulvar pain, itching sensation and external vulvar discomfort. (Brown teaches more than 50% of patients with TV are asymptomatic or have minimal symptoms; symptomatic patients with TV may report abnormal vaginal discharge, itching, burning, or postcoital bleeding (p. 2, ¶ 0005).)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for collecting data, processing the data, determining the likelihood of a vaginal disorder diagnosis, and recommending treatment options by receiving answers to questions from patients as disclosed by Apte to incorporate the information being an itching sensation condition as taught by Brown. This modification would create a system and method capable of improving diagnosis of vaginal disorders to provide effective treatment (see Brown, abstract).
Regarding Claim 9, Apte and Brown teach the limitations as seen in the rejection of Claim 7 above. Apte does not disclose the following limitation met by Brown:
wherein if the result of sialidase activity test is positive, the subject is experiencing at least one of the following conditions: fishy smell and increased or abnormal discharge. (Brown teaches the diagnosis is based on the presence of the following 4 Amsel criteria: … 4. Positive KOH: positive KOH whiff test result (p. 2, ¶ 0010). Paladine has noted that newer laboratory tests such as DNA and antigen testing for BV and VVC, or vaginal fluid sialidase testing for BV, may have similar or better sensitivity and specificity compared with traditional office-based testing (p. 4, ¶ 0010).Defined as inflammation or infection of the vagina, vaginitis presents a spectrum of symptoms, including itching, burning, irritation, dyspareunia, vaginal odor, and abnormal vaginal discharge (p. 1, ¶ 0002).)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for collecting data, processing the data, determining the likelihood of a vaginal disorder diagnosis, and recommending treatment options by receiving answers to questions from patients as disclosed by Apte to incorporate the positive sialidase test indicating a vaginal condition aligning with the presence of an odor or abnormal discharge as taught by Brown. This modification would create a system and method capable of improving diagnosis of vaginal disorders to provide effective treatment (see Brown, abstract).
Regarding Claim 10, Apte and Brown teach the limitations as seen in the rejection of Claim 7 above. Apte further discloses:
…the subject is recommended… (Apte discloses generating a…recommendation based on the set of microbiome targets S160; and promoting the… recommendation in coordination with presenting information derived from the diagnostic analysis S170 [0013].)
Apte does not disclose the recommendation being a recommendation of a test if the pH is greater than a threshold which is met by Brown:
wherein if the pH is greater than 4.5, the subject is…to undergo a trichomonas antigen test. (Brown teaches an elevated pH (ie, >= 4.5) is common with BV or TV (Trichomonas vaginalis). The absence of trichomonads in saline, or fungal elements in KOH samples, does not rule out these infections because the sensitivity of microscopy is approximately 50% compared with more recent nucleic acid amplification tests (NAATs) (p. 2, ¶ 0009).)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for collecting data, processing the data, determining the likelihood of a vaginal disorder diagnosis, and recommending treatment options as disclosed by Apte to incorporate the recommendations including a trichomonas antigen test if the patient has a pH greater than 4.5 as taught by Brown. This modification would create a system and method capable of improving diagnosis of vaginal disorders to provide effective treatment (see Brown, abstract).
Regarding Claim 17, Apte discloses the limitations as seen in the rejection of Claim 14 above. Apte further discloses the following:
wherein diagnosing the vaginal disorder comprising …candidiasis, bacterial vaginosis and trichomoniasis or vaginitis. (Apte discloses the method 100 can additionally, simultaneously and/or contemporaneously test a sample for condition-associated prokaryotic organisms including:… Gardnerella vaginalis (associated with Vaginitis),…additionally, simultaneously and/or contemporaneously test a sample for condition-associated eukaryotic organisms including Trichomonas vaginalis (associated with Trichomoniasis)…[0016].)
Apte does not disclose the diagnosing of vulvar conditions which is met by Brown:
…diagnosing vulvar conditions,… (Brown teaches current ACOG guidelines, which acknowledge that appropriate office-based tools may not always be available, allow for the use of commercial tests that have been approved by the FDA for the diagnosis of vulvovaginitis in such circumstances. Payer policies for vulvovaginitis must similarly evolve to cover the use of these tests, reducing any cost burden to patients (p. 6, ¶ 0001). The Examiner interprets vulvovaginitis as a vulvar condition.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for collecting data, processing the data, determining the likelihood of a vaginal disorder diagnosis, and recommending treatment options as disclosed by Apte to incorporate the diagnosing being for a vulvar condition as taught by Brown. This modification would create a system and method capable of improving diagnosis of vulvar conditions to provide effective treatment (see Brown, abstract).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Apte et al. (US 20170002432 A1) and Brown et al. (Brown et al. “Improving the Diagnosis of Vulvovaginitis: Perspectives to Align Practice, Guidelines, and Awareness.” Population health management vol. 23,S1 (2020)) in view of Holl et al. (US 20220259156 A1).
Regarding Claim 11, Apte and Brown teach the limitations as seen in the rejection of Claim 10 above. Apte further discloses:
…the subject is asked if… (Apte discloses a subject can order a sampling kit through an electronic (e.g., online) ordering system, whereby the subject completes an initial screening survey that asks for age information and sexual activity status (e.g., “are you sexually active?”). Upon completion of the survey, the subject can then be directed to provide information required for completion of the order [0030].)
Apte and Brown do not teach the following limitation met by Holl:
wherein if the result of the trichomonas antigen test is negative, …the subject is experiencing at least one of the following conditions: fishy smell and increased or abnormal discharge. (Holl teaches a clinical outcome responder is a subject with normal vaginal discharge, normal vaginal pH, normal laboratory testing results (including, but not limited to … negative rapid antigen,…[0092]. The subject is a female presenting with an off-white (milky or gray), thin, homogeneous vaginal discharge, an odor, or a combination thereof [0068].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for collecting data, processing the data, determining the likelihood of a vaginal disorder diagnosis, and recommending treatment options as disclosed by Apte to incorporate testing for trichomonas and if the patient is negative, they are experiencing odor or abnormal discharge as taught by Holl. This modification would create a system and method capable of properly treating trichomoniasis (see Holl, ¶ 0002).
Regarding Claim 12, Apte and Brown teach the limitations as seen in the rejection of Claim 10 above. Apte further discloses:
an…analysis module (Apte discloses In relation to the sample processing module, the module can function to process a collected sample into a form suitable for sequencing and/or analysis in generating diagnostic results, microbiome insights, and/or a recommended therapy [0101].)
Apte and Brown do not teach the following limitation met by Holl:
wherein if the result of the trichomonas antigen test is negative, the one or more images are analyzed by an image… (Holl teaches microscopy (such as, but not limited to culture on Diamond's medium) is a key step in the evaluation of vaginal discharge, and is often the first step in the diagnostic evaluation for trichomoniasis. Microscopy is convenient and low cost. In some embodiments, nucleic acid amplification tests (“NAAT”) can then be done for subjects with non-diagnostic (or negative) wet mounts [0091]. The Examiner interprets microscopy as image analysis.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for collecting data, processing the data, determining the likelihood of a vaginal disorder diagnosis, and recommending treatment options as disclosed by Apte to incorporate using image analysis to analyze images as taught by Holl. This modification would create a system and method capable of properly treating trichomoniasis (see Holl, ¶ 0002).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Apte et al. (US 20170002432 A1) and Brown et al. (Brown et al. “Improving the Diagnosis of Vulvovaginitis: Perspectives to Align Practice, Guidelines, and Awareness.” Population health management vol. 23,S1 (2020)) in view of Kelly et al. (Kelly KG. Tests on Vaginal Discharge. In: Walker HK, Hall WD, Hurst JW, editors. Clinical Methods: The History, Physical, and Laboratory Examinations. 3rd edition. Boston: Butterworths; 1990. Chapter 179.).
Regarding Claim 13, Apte and Brown teach the limitations as seen in the rejection of Claim 7 above. Apte further discloses:
an…analysis module (Apte discloses In relation to the sample processing module, the module can function to process a collected sample into a form suitable for sequencing and/or analysis in generating diagnostic results, microbiome insights, and/or a recommended therapy [0101].)
Apte does not disclose the following limitation met by Brown:
wherein if the result of the candida antigen test is negative …the one or more images are analyzed by an image analysis module to confirm presence of Candida organism. (Brown teaches a diagnostic test using NAAT, if available, is strongly advised if BV or TV is suspected. Gaydos et al note that if microscopy is negative but yeast is suspected, additional testing by culture or NAAT for the Candida species is important (p. 4, ¶ 0006). The examiner interprets the diagnostic test using NAAT as an imaging test.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for collecting data, processing the data, determining the likelihood of a vaginal disorder diagnosis, and recommending treatment options as disclosed by Apte to incorporate the if the candida test is negative, conducting an imaging test as taught by Brown. This modification would create a system and method capable of improving diagnosis of vulvar conditions to provide effective treatment (see Brown, abstract).
Apte and Brown do not teach the pH being less than 4.5 which is met by Kelly:
and the pH is less than 4.5, (Kelly teaches the normal vaginal discharge is white, nonhomogeneous, and viscous…The pH is below 4.5, usually between 3.8 and 4.2 (p. 1, ¶ 0001). Candida vaginitis may elicit no vaginal discharge…The pH is normal (p. 3, ¶). The Examiner interprets the normal pH as being less than 4.5.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for collecting data, processing the data, determining the likelihood of a vaginal disorder diagnosis, and recommending treatment options as disclosed by Apte to incorporate the pH being less than 4.5 as taught by Kelly. This modification would create a system and method capable of properly identifying a candida vaginitis infection (see Kelly, p. 2 ¶ 0007-8).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Apte et al. (US 20170002432 A1) in view of Grove et al. (US 20110184254 A1).
Regarding Claim 15, Apte discloses the limitations as seen in the rejection of Claim 14 above. Apte does not disclose the following limitations met by Grove:
wherein said device comprising a collection apparatus for collecting and sampling vaginal discharge or fluid and a sensor for processing the sampling vaginal discharge, said sensor comprising at least two lateral flow assays (LFAs). (Grove teaches the invention includes a diagnostic kit comprising lateral flow devices, such as immunochromatographic strip (ICS) tests, using immunoflowchromatography. The lateral flow devices employ lateral flow assay techniques [0140]. The Examiner interprets the devices containing multiple tests as comprising at least two lateral flow assays. The test is housed in a lateral flow cartridge, and PG-IAI biomarker signal intensities are measured using a lateral flow reader. The CVF is collected using a non-invasive CVF swab using a swab collection kit [0160]. Cervical vaginal fluid was collected by swabbing the cervical os with a polyester swab (Puritan, Guilford, Me.), which was then placed into a container with .about.1 mL of specimen collection buffer [0168].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for collecting data, processing the data, determining the likelihood of a vaginal disorder diagnosis, and recommending treatment options as disclosed by Apte to incorporate a collection apparatus and the use of lateral flow assays as taught by Grove. This modification would create a system and method capable of capable of identifying an early diagnosis in infections to allow for timely treatment and intervention (see Grove, ¶ 0009).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Apte et al. (US 20170002432 A1) in view of Chaim et al. (Chaim W, Karpas Z, Lorber A. New technology for diagnosis of bacterial vaginosis. Eur J Obstet Gynecol Reprod Biol. 2003).
Regarding Claim 21, Apte discloses the limitations as seen in the rejection of Claim 14 above. Apte does not disclose the following limitation met by Chaim;
further comprising an amine sensor. (Chaim teaches there are several analytical techniques for measurement of amines in general, and biogenic amines in particular…The use of solid state sensors for determination of amines has also been reported. Elevated levels of biogenic amines like trimethylamine (TMA), putrescine and cadaverine may also be found in the vaginal discharge of women presenting certain pathological conditions. (p. 1, ¶ 0001).)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system and method for collecting data, processing the data, determining the likelihood of a vaginal disorder diagnosis, and recommending treatment options as disclosed by Apte to incorporate the use of an amine sensor as taught by Chaim. This modification would create a system and method capable of providing a diagnosis for bacterial vaginosis based off of the levels of trimethylamine (see Chaim, p. 5 ¶ 0003).
Relevant Prior Not Currently Being Applied Made of Reference
The following prior art is considered pertinent to Applicant’s disclosure but is not currently being applied:
Pacquit et al. (Pacquit et al., Development of a volatile amine sensor for the monitoring of fish spoilage, Talanta, Volume 69, Issue 2, 2006.) teaches a sensor which measures volatile basic amines.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA R GEDRA whose telephone number is (5