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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 26, 2026 has been entered.
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30 - 31, 33 - 34, 50 – 53 are pending; claims 1 - 2, 4 - 6, 8 - 9, 15 - 17, 19 - 20, 24 - 26, 30 - 31, 34 and 50 are withdrawn; claims 33 and 51 – 53 has been considered on the merits.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 Objections
Claim 1 is objected to because of the following informalities: in line 13, “as” should read “has.” Appropriate correction is required.
Claim Interpretation
In claim 33, the method for increasing Lactobacillus species 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.
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 remain indefinite for reciting “parameters” because the terms is not adequately defined by the claim language or specification. 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. While the claim newly recites the parameters are “correlated with” concentrations of various metabolites, no specific correlation is identified, e.g., pH, concentration of bacteria or presence of particular bacteria.
In claim 33, line 7 the recitation of “is correlated with” remains indefinite because neither the claim nor the specification indicates how the concentrations of metabolites are correlated to any particular “parameter.” Clarification is required.
In claim 33, the recitation of "identifying" a subject fails to require any active step, rendering the limitation indefinite as to what the scope of the claim includes and excludes.
In claim 51, the phrase "is further correlated with" renders the claim indefinite as the phrase fails to positively recite any specific correlation such that one practicing the invention would know what is required by the method, what is included and what is excluded. The phrase fails to define how a metabolomic profile correlates to concentrations of the various compounds/metabolites; what result must occur to "correlate" with an undefined parameter; and how the undefined and unrecited parameter forms the basis of identifying a subject as having a dysbiotic microbiome.
Response to Arguments
Applicant argues the claims are clear as amended.
However, this argument fails to persuade because claim 33 (and newly amended claim 51) continues to recite unspecified parameters of the metabolomic profile are "correlated with" concentrations of various compounds without any specific indication of what the correlation is, or how the concentrations are "correlated with" the undefined parameter. In addition, the claims remain indefinite for the reasons iterated above.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 33, 51 and 53 are rejected under 35 U.S.C. 102a1 as being anticipated by Decena et al. (2006).
Regarding claims 33, 51 and 53, Decena teaches increasing Lactobacillus colony count (species dominance) in the vagina of subjects with bacterial vaginosis (BV) (genital region of a subject 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 (a parameter) (p.244-246) and diagnoses BV wherein BV is defined as altered balance of vaginal flora, or dysbiosis of genital metabolic profile (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).
Although Decena does not expressly teach the methods wherein the parameters are correlated with concentration of tyramine, cadaverine, agmatine or a combination thereof, Decena teaches BV is characterized by increased concentration of amines such as putrescin, cadaverine, tyramine and methylamine (p.249), indicating that concentration of these compounds contribute to the “whiff test” or amine levels measured. This is interpreted as Decena measuring a parameter that “is correlated with” concentrations of the claimed compounds.
Therefore, the reference anticipates the claimed subject matter.
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 and 51 – 53 are rejected under 35 U.S.C. 103 as being unpatentable over Decena et al. (2006) in view of Bogavac et al. (2017).
Regarding claims 33, 51 and 53, Decena teaches increasing Lactobacillus colony count (species dominance) in the vagina of subjects with bacterial vaginosis (BV) (genital region of a subject 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 (a parameter) (p.244-246) and diagnoses BV wherein BV is defined as altered balance of vaginal flora, or dysbiosis of genital metabolic profile (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).
Although Decena does not expressly teach the methods wherein the parameters are correlated with concentration of tyramine, cadaverine, agmatine or a combination thereof, Decena teaches BV is characterized by increased concentration of amines such as putrescin, cadaverine, tyramine and methylamine (p.249), indicating that concentration of these compounds contribute to the “whiff test” or amine levels measured. This is interpreted as Decena measuring a parameter that “is correlated with” concentrations of the claimed compounds.
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 claims require measuring concentrations of tyramine, cadaverine, agmatine or combinations thereof.
However, this argument fails to persuade. The claims do not require measuring concentrations of tyramine, cadaverine, agmatine or combinations thereof as argued by applicant. Rather the claims require measuring "one or more parameters" of a metabolomic profile wherein the parameter "is correlated with" concentrations of these metabolites. In this regard, measuring pH and/or amines of a metabolomic profile can be "correlated with" concentrations of these specific metabolites as they are each strong bases and occur in increased concentration and as disclosed by Decena. Notwithstanding, as stated above, the claimed metabolites were well known to be associated with BV, as disclosed by Decena. Thus, at the time the claims were filed one of ordinary skill in the art would have been motivated by the cited referenced to measure at least pH, tyramine, cadaverine, agmatine, or combinations thereof with a reasonable expectation for successfully identifying a subject with BV, and treating with an acidic composition to increase lactobacillus colony count therein.
Absent evidence of an unexpected result or benefit, the claims remain rejected.
No claims are allowed.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RUTH A DAVIS/Primary Examiner, Art Unit 1699
Prosecution Insights