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 the Claims
Claims 1, 3, 6-15, 18-20, and 22-26 are pending (claim set as filed on 7/29/2024). Claims 2, 4-5, 16-17, and 21 are cancelled. Claims 3, 22, and 24-25 are withdrawn after restriction/election requirement. Claims 1, 6-15, 18-20, 23, and 26 are under examination.
Election/Restrictions
Claims 3, 22, and 24-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected methods, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/1/2026.
The biomarker species lactoylcysteine is elected by the applicant as it applies to claim 3 in their written response filed on 5/1/2026. However, the species lactoylcysteine is not listed in the claim. Therefore, claim 3 is withdrawn as it is not directed towards the elected biomarker lactoylcysteine.
Priority
Applicant is advised of possible benefits under 35 U.S.C. 119(a)-(d) and (f), wherein an application for patent filed in the United States may be entitled to claim priority to an application filed in a foreign country.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. GB2110293.4, filed on 1/11/2024.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, and thus this application has priority benefit to the effective filing date of 7/16/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/6/2024 was considered, initialed, and attached hereto. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to because the text on pages 4-5, 32-34, and 44-46 are blurry and difficult to read. Applicant is required to provide drawings for the specified pages with clearly readable text. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 10 is objected to because of the following informalities: the phrase “an uterine mucosa membrane” is grammatically incorrect. Appropriate correction is required to change to “a uterine mucosa membrane”
Claim Rejections - 35 USC § 112
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 7-8, 19, 20, and 23 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 7 recites the term “simultaneously” and it is unclear what the term is attempting to limit. This language renders the claim indefinite as it is unclear as to how one could obtain the subject's mucosal inflammatory state, level of mucosal immune activation, or microbial composition at the same time if one is limited to choosing one of these options. As the options are listed in alternative, they cannot be obtained at the same time as only one can be obtained at any given time. For examination purposes, the claim has been interpreted to mean the subject’s mucosal inflammatory state, level of mucosal immune activation, or microbial composition are obtained. It is unclear if claim 8 is attempting to use Markush grouping of alternatives. If so, Markush groupings should not recite the open-ended language, “comprising”, and should instead use “consisting of” language. If the applicant uses Markush language, they are required to recite a closed group “consisting of” alternative members. See MPEP § 2111.03.
Claims 19 and 20 recite “a suitable course of treatment” in the claim language which is relative claim terminology. However, the utilization of such as phrase is indefinite as the applicant provides no definition or examples of what a suitable treatment would entail in the claim or specification and one would not understand what suitable encompasses. For examination purposes, any treatment administered is interpreted to read on the claims.
Claim 23 recites the term “preferably” which renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 1, 6-15, 18-20, 23, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Oberoi (Pre-Grant Publication No. US 2020/0400682 A1 – date of publication 12/24/2020), in view of Chaves Fontes (Patent No. US 10,634,686 B2 – date of patent 4/28/2020), and in further view of Pruski (Pruski et al., “Medical Swab Analysis Using Desorption Electrospray Ionization Mass Spectrometry: A Noninvasive Approach for Mucosal Diagnostics”, 2016 Dec 27, Analytical Chemistry, 89, pgs. 1540-1549).
Oberoi’s general disclosure relates to predictive models and kits for assessing inflammatory diseases based on biomarkers (see abstract).
Regarding claim 1, Oberoi teaches obtaining a mucus sample from a subject (see [0133]) to identify the presence and level of a biomarker (see [0168]). Oberoi teaches that a metabolic profile is formed from the presence and level of the biomarker in the form of a DAI score (see [0168]). Oberoi also teaches the use of an algorithm, embodied as a reference population-trained neural network which is a subset of a machine learning model (see [0101]). Oberoi teaches that the algorithm is pre-trained with metabolic and immune-profiling data from the reference DAIMRK population dataset (see [0142] and [0121]). The prior art also teaches that the algorithm is used to predict a subject’s inflammatory state and immune activation (see [0143]), and as the tested sample is mucus it is reasonable to interpret that the prediction of such a state is determined to be within a mucus membrane.
Regarding claim 1, Oberoi does not teach the specified biomarker lactoylcysteine or obtaining the microbial composition of the mucosal sample.
Chaves Fontes’s general disclosure relates to a method of identifying biomarkers to predict organ or tissue dysfunction (see abstract).
Regarding claim 1, Chaves Fontes teaches the biomarker N-acetylcysteine, also known as lactoylcysteine (see col. 25-26, Table 8).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to add the lactoylcysteine biomarker as taught in Chaves Fontes to the metabolic profile as taught in Oberoi. One would be motivated to do so because Chaves Fontes teaches that lactoylcysteine is a biomarker found in perfusate (blood and lymphatic fluid) (see col. 25-26, Table 8) and its detection can be used to predict the risk of organ dysfunction in a subject (see Chaves Fontes abstract). This addition would be advantageous to the disclosure of Oberoi which recognizes the need for biomarkers to provide quantitative data to create a DAI score which measures disease activity in a subject (see Oberoi [0121]).
Regarding claim 1, Chaves Fontes does not teach obtaining the microbial composition of the mucosal sample.
Pruski’s general disclosure relates to the use of a direct swab analysis via DESI-MS for microbiological and immune diagnostics (see abstract).
Regarding claim 1, Pruski teaches obtaining the microbial composition of the mucosal sample (see pg. 1542, ¶ 1).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to add the step of obtaining the microbial composition of the mucosal sample as taught in Pruski to the method as taught in Oberoi and Chaves Fontes. The ordinary artisan would have been motivated to do so because Pruski teaches that detecting specific bacteria in the mucosa could be used to generate data for clinical decision making (see pg. 1548, ¶ 2 and pg. 1549, ¶ 1). This additional step would have improved upon Oberoi and Chaves Fontes’s disclosure which describes the intended use of their method is to provide subject-specific biological information to facilitate improved therapeutic treatment (see Oberoi [0192]).
Regarding claim 6, modified-Oberoi-Chaves Fontes-Pruski teaches the prediction of the subject’s mucosal inflammatory state, level of mucosal immune activation, or microbial composition is based solely on the metabolic profile, which is the presence of level of the specified biomarker(s) from the subject sample (see Oberoi [0015]).
Regarding claim 7, modified-Oberoi-Chaves Fontes-Pruski teaches the subject’s inflammatory state (see Oberoi [0005]) based on the subject’s biological sample, embodied as mucus (see Oberoi [0133]). As noted in the 112b rejection above, the claim is rendered indefinite by the use of “simultaneously” while also reciting “or” language. The examiner has interpreted the claim to mean inflammatory state, level of mucosal immune activation, or microbial composition and thus modified-Oberoi-Chaves Fontes-Pruski reads on the claim by teaching the inflammatory state.
Regarding claim 8, modified-Oberoi-Chaves Fontes-Pruski teaches the immune-profiling data from the reference DAIMRK population dataset (see Oberoi [0121]) wherein the biomarkers are selected from cytokines, chemokines, growth factors, and complement competent molecules (see Oberoi [0121]).
Regarding claim 9, modified-Oberoi-Chaves Fontes-Pruski teaches the presence of the biomarkers IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL- 10, IL-18, IFN-γ (also known as interferon gamma), GM-CSF (also known as colony-stimulating factor 2), and TNF-α (see Oberoi [0102]).
Regarding claim 10, modified-Oberoi-Chaves Fontes-Pruski teaches a nasal, oral, gastrointestinal and vaginal mucosal membrane (see Pruski pg. 1541, Figure 1 and pg. 1541, ¶ 4).
Regarding claim 11, modified-Oberoi-Chaves Fontes-Pruski teaches a swab sample (see Pruski pg. 1541, Figure 1). Modified-Oberoi-Chaves Fontes-Pruski also teaches the swab in the DESI-MS device provides high specificity and selectivity (see Pruski pg. 1541, ¶ 4).
Regarding claim 12, modified-Oberoi-Chaves Fontes-Pruski teaches the swab is a urogenital tract (of a female) swab which reads on cervicovaginal swab as the genital tract includes both the cervix and vagina (see Pruski pg. 1541, Figure 1). Modified-Oberoi-Chaves Fontes-Pruski also teaches the swab is a nasal swab (see Pruski pg. 1541, Figure 1).
Regarding claim 13, modified-Oberoi-Chaves Fontes-Pruski teaches the mucosal sample is analyzed using mass spectrometry or an ambient spectroscopy technique (see Pruski pg. 1541, ¶ 4).
Regarding claim 14, modified-Oberoi-Chaves Fontes-Pruski teaches DESI-MS (see Pruski pg. 1541, ¶ 4).
Regarding claim 15, modified-Oberoi-Chaves Fontes-Pruski teaches metabolic profile is obtained 30 seconds after the sample is obtained from the subject, which is within the 3-10 minutes claimed range (see Pruski pg. 1545, ¶ 1).
Regarding claim 18, modified-Oberoi-Chaves Fontes-Pruski teaches that the subject had previously had a sample analyzed for biomarkers as all samples were tested at least in duplicate, indicating that the sample analysis per subject has occurred at least once before (see Oberoi [0224]).
Regarding claim 19, modified-Oberoi-Chaves Fontes-Pruski teaches wherein a suitable course of treatment is determined for the subject based on a comparison of their DAI scores, which is indicative of their inflammatory state (see Oberoi [0036] and [0046]). Modified-Oberoi-Chaves Fontes-Pruski further teaches that the inflammatory state is indicative of a vaginal infection, specifically bacterial vaginosis (see Pruski pg. 1541, ¶ 1). As indicated in the 112b rejection above, the recitation of “a suitable course of treatment” is indefinite as the definition what constitutes what “suitable” treatment is remains unclear and thus the claim is rendered indefinite. The examiner has chosen to interpret any treatment administered to read on the claim.
Regarding claim 20, modified-Oberoi-Chaves Fontes-Pruski teaches monitoring the subject’s response to the aforementioned treatment (see Oberoi [0047]). As indicated in the 112b rejection above, the recitation of “a suitable course of treatment” is indefinite as the definition what constitutes what “suitable” treatment is remains unclear and thus the claim is rendered indefinite. The examiner has chosen to interpret any treatment administered to read on the claim.
Regarding claim 23, modified-Oberoi-Chaves Fontes-Pruski teaches a vaginal infection and specifically a bacterial vaginosis infection (see Pruski pg. 1547, Figure 7).
Regarding claim 26, modified-Oberoi-Chaves Fontes-Pruski teaches a DESI-MS kit comprising a first device to direct a spray of charged droplets onto the surface of a swab to generate a plurality of analyte ions (see Pruski pg. 1541, Figure 1).
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Modified-Oberoi-Chaves Fontes-Pruski also teaches a PCA second device that analyzes said analyte ions (see Pruski pg. 1541, ¶ 4) for the presence or level of biomarkers such as lactoylcysteine (see Chaves Fontes col. 25-26, Table 8).
Conclusion
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emmalee R. Williams whose telephone number is (571)272-5472. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.R.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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