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 .
Applicant’s amendment and reply filed November 5, 2025 have been received and entered into the case. Claims 51 – 53 are added; claims 1 - 2, 4 - 6, 8 - 9, 15 - 17, 19 - 20, 24 - 26, 30 - 31, 33 - 34, 50 – 53 are pending; claims 1 - 2, 4 - 6, 8 - 9, 15 - 17, 19 - 20, 24 - 26, 30 - 31, 34 and 50 are withdrawn; claims 33 and 51 – 53 has been considered on the merits. All arguments have been fully considered.
Claim Interpretation
In claim 33, the method for optimizing beneficial microbiome growth requires “a subject in need.” The specification defines this to include subjects that may be receiving treatment in the future or one for whom it is desirable which is undefined (0061). In this regard, for purposed of examination, the subject is interpreted to include any subject since any subject might need future treatment.
In addition, claim 33 includes “means plus function” language that is interpreted under 35 U.S.C. 112(f). Specifically, the “at least one measurement system” and “a correlation system” are claimed by the function they perform without any specific structure to carry out the function. The specification fails to specifically define or disclose these structures, but alludes generically to sensor arrays for a measurement system and the function of transmitting electrical properties to external devices as a correlation system with examples of laptops, tablets, computers or smart phones (0231). Thus, the limitations are considered include any structure that performs the function of “measuring” and “correlation.”
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 33 and 51 – 53 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 33 and its dependents are drawn to a method for increasing Lactobacillus species dominance the genital region of a subject however is rendered indefinite for reciting the following terms and phrases because they are not adequately defined by the claim language or specification.
“beneficial” bacteria – in paragraphs 0051 – 0055 of the specification, generalizations of bacteria are disclosed as part of a microbiome, however no specific definition is provided for what constitutes a “beneficial” microbiome.
“parameters” – the specification is absent any examples of what parameters of the metabolomic profile may or may not include, let alone a definition of the term.
In claim 33, lines 16 – 20 render the claim indefinite as it is unclear if the measured parameter is “correlated with” the number of pathogenic bacteria and also the number of beneficial bacteria or if the parameter is correlated with the bacteria in the alternative. Clarification is required.
In claim 33, the method requires that a measured parameter identifies presence of dysbiosis in lines 19 – 20, however also recites “if” the subject is identified to have dysbiosis, rendering the claim vague and indefinite. It is unclear if a specific result must occur to meet the limitations of the claim and whether “applying a pharmaceutical” is required by the method. For purposes of examination, the claim is interpreted to mean applying a pharmaceutical composition is optional and therefore not required by the claim language.
In claim 33, the phrase “based on the one or more parameters of the metabolomic profile” renders the claim indefinite because it fails to provide an adequate or positive correlation of any result such that one practicing the method would understand what active step must be carried out and under what condition. For example, it is unclear if the mere existence of an unspecified/unidentified “parameter” is sufficient to “correlate with” or if the unspecified/unidentified parameter must meet a particular threshold or measurement.
Claim 51 is indefinite for reciting “wherein the measurement system measures” because it is unclear if the method requires active steps to measure the identified metabolites or if the claim intends to further limit the measurement system, e.g., an intended use of the system. Moreover, no additional active steps are recited that must be carried out by the method and no additional limitation is recited to further limit the system itself. For purposes of examination, the claim is intended to recite an intended use of the measurement system.
Claim 53 is drawn to a method for increasing Lactobacillus species dominance in the genital region of a subject however is rendered indefinite because not all of the recited biological sample types provide a parameter of a genital metabolomic profile. Specifically, saliva, tears and nasal swabs.
Claim 53 is further indefinite for reciting “is derived from” the various samples as it is unclear if the limitation requires an unrecited step that must be actively carried out. Clarification is required.
Claim 53 is indefinite for reciting “legions” in line 2, as it is unclear what applicant intends to encompass by the term.
Response to Arguments
Regarding the term “beneficial” bacteria in line 18, applicant argues that a person of ordinary skill in the art would understand what is included and excluded in the phrase “beneficial bacteria.”
However, this argument is not persuasive since the term is not specifically delineated by the claim language or specification. Since “beneficial” bacteria can become harmful under different environmental or host conditions, the term may vary over time, within a population and/or within a given host. Moreover, the term fails to clearly set forth the scope of the claimed invention.
Regarding the term “parameters,” applicant argues specific parameters are now recited.
However, claim 33 still fails to recite any specific parameter. Specifically, a parameter “correlated with” undefined “pathogenic bacteria” or undefined “beneficial bacteria” that indicates dysbiosis is not a specific parameter nor are they defined by the specification. Although examples of pathogenic and beneficial bacteria are disclosed in paragraphs 0075 and 0123 of the published application, respectively, the examples are not definitions of the terms nor are they definitions of parameters that are “correlated with” the undefined species. Even if these bacteria are specified, the term “parameters” remains undefined and without a clear delineation of the scope of the invention.
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 33, 51 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Decena et al. (2006) in view of Star (US 2014/0318991).
Regarding claims 33 and 53, Decena teaches increasing Lactobacillus colony count in the vagina of subjects with bacterial vaginosis (BV) (subjects in need of treatment) comprising administering lactic acid gel (a pharmaceutical composition with an acidic pH) to the genital area. Specifically, Decena confirms, or measures, several parameters of a genital metabolic profile: vaginal pH, amine levels, presence of clue cells in the wet smear and vaginal discharge, which are obtained from genital fluid samples, or a biological sample (p.245-246); correlates the measurements to the numbers of pathogenic and normal (beneficial) flora (p.244-246) and diagnoses BV wherein BV is defined as altered balance of vaginal flora, or dysbiosis (p.244, left col.). The diagnosed subjects are then treated with the lactic acid gel for the purpose of decreasing and restoring vaginal pH (p.244-246).
Decena does not teach the methods wherein parameters are measured with the claimed system. However, at the time the claims were filed, systems for measuring pH of and analytes (parameters of metabolomic profiles) in biological samples were known in the art. For example, Star teaches systems for measuring pH and where the system includes a substrate; a sensor medium including at least one oxidizes carbon nanostructure with a pH responsive (conductive) material deposited thereon (abstract); at least two conductive terminals in connection with the sensor medium (0008); a measurement system for measuring a property of the sensor and sensor medium (abstract); and a spectrophotometer (a computerized system which correlates measurements) (0075 – 0079). Star teaches the systems are easily modified to measure various analytes (0066). Thus, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to use a system comprising the claimed components as a matter of routine practice since they were well known in the art for measuring pH of samples and modifiable for other analytes.
Regarding claim 51, the combined references do not teach the method or system wherein the system can be used to measure the claimed metabolites. However, these limitations are interpreted as product by process type limitations of the system. The intended use of the claimed system does not patentably distinguish the system or method, per se, since such undisclosed use is inherent in the reference composition. Specifically, Star indicates that the systems are easily modified and functionalized to detect analytes of interest and their concentration (0065 - 0066). In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112).
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Claims 33 and 51 – 53 are rejected under 35 U.S.C. 103 as being unpatentable over Decena et al. (2006) in view of Star (US 2014/0318991); and further in view of Bogavac et al. (2017).
Regarding claims 33 and 53, Decena teaches increasing Lactobacillus colony count in the vagina of subjects with bacterial vaginosis (BV) (subjects in need of treatment) comprising administering lactic acid gel (a pharmaceutical composition with an acidic pH) to the genital area. Specifically, Decena confirms, or measures, several parameters of a genital metabolic profile: vaginal pH, amine levels, presence of clue cells in the wet smear and vaginal discharge, which are obtained from genital fluid samples, or a biological sample (p.245-246); correlates the measurements to the numbers of pathogenic and normal (beneficial) flora (p.244-246) and diagnoses BV wherein BV is defined as altered balance of vaginal flora, or dysbiosis (p.244, left col.). The diagnosed subjects are then treated with the lactic acid gel for the purpose of decreasing and restoring vaginal pH (p.244-246).
Decena does not teach the methods wherein parameters are measured with the claimed system. However, at the time the claims were filed, systems for measuring pH of and analytes (parameters of metabolomic profiles) in biological samples were known in the art. For example, Star teaches systems for measuring pH and where the system includes a substrate; a sensor medium including at least one oxidizes carbon nanostructure with a pH responsive (conductive) material deposited thereon (abstract); at least two conductive terminals in connection with the sensor medium (0008); a measurement system for measuring a property of the sensor and sensor medium (abstract); and a spectrophotometer (a computerized system which correlates measurements) (0075 – 0079). Star teaches the systems are easily modified to measure various analytes (0066). Thus, at the time the claims were filed, it would have been obvious to one of ordinary skill in the art to use a system comprising the claimed components as a matter of routine practice since they were well known in the art for measuring pH of samples and modifiable for other analytes.
Regarding claim 51, the combined references do not teach the method or system wherein the system can be used to measure the claimed metabolites. However, these limitations are interpreted as product by process type limitations of the system. The intended use of the claimed system does not patentably distinguish the system or method, per se, since such undisclosed use is inherent in the reference composition. Specifically, Star indicates that the systems are easily modified and functionalized to detect analytes of interest and their concentration (0065 - 0066). In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112).
Regarding claim 52, Decena does not teach the method wherein the claimed actives are administered. However, Bogavac teaches essential oils of Rosmarinus officinalis is effective to treat bacterial vaginosis (abstract, Table 2) which contains borneol (p.127, Table 1) and is disclosed as containing prodrug bornyl acetate and a preferred active by applicant (0137 of the published application). As such, at the time the claims were filed, one of ordinary skill in the art would have been motivated to administer subjects with BV essential oils of Rosmarinus officinalis for its known therapeutic value and with a reasonable expectation for successfully treating BV.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 33 and 51 – 53 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of copending Application No. 18/479 756 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a method of optimizing the beneficial microbiome growth in the genital region of a subject in need thereof comprising measurement of one or more parameters of the metabolomic profile of a biological sample with a system and application of a pharmaceutical composition having an acidic pH to the genital region of the subject or to the genital region of a sexual partner of the subject in need thereof based on the one or more parameters of the metabolomic profile. The systems both comprise a substrate; a sensor medium immobilized on said substrate comprising a microfluidic chip and/or a plurality of carbon nanostructures; wherein the plurality of carbon nanostructures have one or more conductive materials deposited thereon; at least two conductive terminals in electrical connection with the sensor medium and spaced from each other; at least one measurement system to measure one or more electrical properties of the sensor medium when the sensor medium comprises the biological sample deposited thereon; and a correlation system calibrated to correlate the measured electrical property with the one or more parameters of the metabolomic profile.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues that the compositions of Decena is not acidic, but that Lactacyd may have a pH of 8; and that the prior art does not teach measuring the numbers of pathogens, beneficial bacteria, or comparing these numbers to healthy or diseased subjects. Applicant’s comments regarding the provisional obvious double patenting rejections are acknowledged.
However, these arguments fail to persuade.
Regarding the argument that the product used in Decena is not acidic, applicant makes reference to a different product, Lactacyd Alkaline pH8, which is intended to treat excess vaginal acidity (Product Description, attached), and not the Lactacyd vaginal gel administered by Decena. Decena discloses administering a lactic acid gel, specifically Lactacyd vaginal gel, wherein the product decreases pH (abstract, p.244 right col.). In this regard, the product is an acidic lactic acid product for restoring physiological pH, e.g., about 3.5 – 4.0, and not one intended to combat excess acidity such as the product argued by applicant.
Regarding the argument that prior art does not teach measuring the numbers of pathogens, beneficial bacteria, or comparing these numbers to healthy or diseased subjects, it is initially noted that the claims neither require steps of measuring the number of pathogens or beneficial bacteria nor steps for comparing numbers to healthy or diseased individuals. In this regard, the arguments are not commensurate with the claimed invention. The claims merely require measuring “one or more parameters” which can be “correlated with” numbers or pathogens, bacteria, and/or dysbiosis (it is iterated that what is required by the claim remains unclear). Notwithstanding, since neither of these steps are specifically active steps, but includes mentally comparing a non-specific parameter (e.g., pH) with bacteria, it is maintained that the prior art teaches the argued limitations. Specifically, Decena confirms (measures) several parameters of a genital metabolic profile: vaginal pH, measuring amine levels, presence of clue cells in the wet smear and vaginal discharge, which are obtained from biological samples (p.245-246), correlates the measurements to the numbers of pathogenic and normal (beneficial) flora (p.244-246) and diagnoses BV wherein BV is defined as altered balance of vaginal flora, or dysbiosis (p.244, left col.). Thus, it is maintained that Decena teaches the claimed active method steps.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
No claims are allowed.
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 RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUTH A DAVIS/Primary Examiner, Art Unit 1699