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 .
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
Claims 1-8 and 10-15 are pending.
Claim 15 is withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Group II. Election was made without traverse in the reply filed on 06 February 2025 to the Restriction/Election Office Action mailed 10 December 2024.
Claims 1-8 and 10-14 are rejected.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. §119(e) or under 35 U.S.C. §120, §121, or §365(c) is acknowledged. This application is a 371 of PCT/EP2020/073450, filed 08/21/2020.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. §119 (a)-(d). The certified copies of EP19193541.0, 08/26/2019 and EP20181446.4, 06/22/2020 were submitted on 24 February 2022.
Applicant has complied with all of the conditions for receiving the benefit of an earlier filing date under 35 U.S.C. §120 or §365(c).
Claims 1-8 and 10-14 have the effective filing date of 26 August 2019.
Claim Interpretations
Claim 7 recites the acronym "cfu".
Claim 7 recites: “…, wherein the composition comprises 0.2 to 5 g of myo-inositol,…, from 1.5 to 100 μg of vitamin D, from 105 to 1012 cfu of Bifidobacterium lactis BB12 CNCMI-3446 and from 105 to 1012 cfu of Lactobacillus rhamnosus GG CGMCC 1.3724,…”
The specification recites: “…, the probiotic is provided in an amount of from 105 to 1012 colony forming units (cfu) per daily dose,…” (originally-filed specification, pg. 8, lines 4-6).
Claim Rejections - 35 U.S.C. § 103
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. §102(b)(2)(C) for any potential 35 U.S.C. §102(a)(2) prior art against the later invention.
Claims 1-8 and 10-14 are rejected under 35 U.S.C. §103 as being unpatentable over Silva Zolezzi et al. (International Patent Application Publication No. WO 2016/020486 A1) in view of Lateef (Adverse Effects of Gestational Diabetes Mellitus (GDM) on Measurements of the Umbilical Cord and its Vessels. Pakistan Journal of Biological Sciences 18 (7): 346-351, 2015)
Regarding claim 1, Silva Zolezzi et al. teach a method of improving insulin sensitivity and/or treating or preventing an IGT (impaired glucose intolerance), type II diabetes and/or GDM (gestational diabetes mellitus), and/or preventing a condition associated with any of the foregoing in a subject, comprising administering a combination of myo-inositol and zinc to said subject (pg. 19, lines 18-22).
Silva Zolezzi et al. teach GDM is a pregnancy disorder that can increase the risk of a number of maternal-fetal conditions and can be associated with preterm (reading on claim 12) and caesarian delivery, birth injury to the mother or baby. (pg. 2 and 3, lines 15-20).
The composition may be administered enterally to the subject (pg. 4, lines 6-8). In the case of GDM the subject may be a pregnant mammal or the offspring of a pregnant mammal (pg. 3, lines 7-8 [i.e., a female subject]).
Regarding claims 2 and 8, Silva Zolezzi et al. shows a combination of zinc and myo-inositol, and/or one or more probiotics (pg. 4, lines 6-8).
Regarding claims 3 and 4, the one or more probiotic bacteria may be any lactic acid bacteria, Bifidobacteria, or combination thereof. Non limiting examples of lactic acid bacteria strains include, minimally, Lactobacillus rhamnosus deposited as number CGMCC 1.3724. Non limiting examples of Bifidobacteria strains include, minimally, Bifidobacterium lactis deposited as number CNCM I-3446 (pg. 8, lines 10-23).
Regarding claim 5, a combination of zinc and myo-inositol, and optionally vitamin D and/or one or more probiotics and/or one or more of vitamin B2, B6, and B12, optionally comprised in a composition, may be administered enterally to a subject (pg. 4, lines 6-8).
Regarding claim 6, in a particular embodiment, the composition comprises myo-inositol and zinc, vitamin D, one or more probiotic, vitamin B2, B6, and B12, B-carotene, folic acid, iron, calcium, and iodine and the one or more probiotic is preferably a mixture of Lactobacillus rhamnosus CGMCC 1.3724 and Bifidobacterium lactis CNCM I-3446 (pg. 20, lines 24-27).
Regarding claim 7, a particularly useful dose of myo-inositol is from 0.2 to 5mg. A particularly useful dose of vitamin B2 may be 0.14 to 14 mg. A particularly useful dose of vitamin B6 is 0.19 to 19 mg. A particularly useful dose of vitamin B12 is 0.26 to 26μg. A particularly useful dose of vitamin D is 1.5 to 100 μg. A particularly useful dose of the one or more probiotic is from 10e5 to 10e12 colony forming units (cfu). The term ‘dose’ refers to a daily quantity that is administered to a subject (pg. 10, lines 16-28).
Regarding claim 10, the term ‘subject’ refers to a mammal (pg. 5, lines 6-7).
Regarding claim 11, pertaining to the subject is a female who is trying to get pregnant, Silva Zolezzi et al. teaches an embodiment of the composition is administered to a subject desiring to get pregnant it may for example be administered during at least 1, 2, 3 or 4 months preceding the pregnancy or desired pregnancy (pg. 12, lines 8-11).
Regarding claim 12, the term ‘prevent’ refers to the prevention of the occurrence, or reduction of the risk of the occurrence, of a condition in a subject (pg. 6, lines 11-12). Non limiting examples of conditions associated with GDM, that affect the pregnant subject and/or its offspring, include, minimally, preterm and caesarian delivery (pg. 19, lines 4-9).
Regarding claim 13, if an embodiment of the composition is administered to a pregnant subject, it may be administered throughout or partially throughout the pregnancy (pg. 12, lines 11-16).
Regarding claim 14, Silva Zolezzi et al. teaches that the term ‘nutritional supplement’, or ‘dietary supplement’ refers to a nutritional product that provides nutrients to an individual that may otherwise not be consumed in sufficient quantities by said individual. Nutritional supplements can for example be provided in the form of, minimally, a powder supplement that can for example be dissolved in an aqueous medium e.g. water or juice (pg. 14, lines 17-22).
Although Silva Zolezzi et al. teach GDM is a pregnancy disorder that increases the risk of maternal-fetal conditions and leads to preterm delivery the reference does not explicitly teach the amended claimed disorder/condition.
Reading on embodiment ii “complications with the umbilical cord”, Lateef teaches pregnancy complicated by uncontrolled maternal diabetes affected the maternal health and the placenta experiences a diversity of structural and functional changes and investigates GMD’s adverse effects on the umbilical cord and its vessels. Abstract. Lateef teaches umbilical cord connects the fetus and the placenta and any abnormality in the cord may have harmful effects on the fetus. The changes can have effects on the fetus and placenta and blood flow. See Discussion section. The study concluded that changes in the cord that were related to GDM were associated with adverse fetal outcomes.
Accordingly, it would have been obvious to one of ordinary skill in the art to combine the teachings of Silva Zolezzi et al. and Lateef et al and expect the administration of Silva Zolezzi’ s composition would prevent complications of the umbilical cord. One would have been motivated to do so since Silva Zolezzi teach administration of myo-inositol to treat gestational diabetes mellitus (GDM) in pregnant women since GDM is a pregnancy disorder that leads to preterm delivery and increases the risk of a number of maternal-fetal conditions and Lateef teaches diabetic pregnancies are associated with altered umbilical cords and vessels which can affect placenta and blood flow and lead to adverse effects. Thus, the treatment of GDM in a pregnant patient would lead to the prevention of adverse pregnancy complications including complications with the umbilical cord which as taught by Lateef causes adverse downstream effects including stillbirth and preterm delivery.
Regarding the limitation ‘conditions linked to PPROM’, the claim limits the condition/disorder to “complications of the umbilical cord” or “separation of the placenta;” thus the combination of Silvia Zolezzi and Lateef teach this limitation. ” Moreover it is noted that the patient population does not suffer from PPROM only the complication “linked” to PPROM. This claim interpretation is supported by dependent claim 12 which limits the claim to a subject “at risk of premature delivery and/or PPROM.” It is also noted that the specification states disorders/conditions linked to PPROM are known to the skilled artisan.
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 1-8 and 10-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 10-14 of copending Application No. 17/753,229 in view of Ebbings et al (Velamentous or marginal cord insertion and the risk of spontaneous preterm birth, prelabor rupture of the membranes, and anomalous cord length, a population-based study. Acta Obstet Gynecol Scand 2017; 96: 78–85).
The claimed subject matter of instant Application No. 17/753,227 is:
Claim 1. A method for preventing a preterm-onset pre-labour rupture of membranes (PPROM) and disorders and/or conditions linked to PPROM in a female subject. The method comprises administering a composition comprising myo-inositol to the female subject. The disorder and/or condition linked to the PPROM is selected from the group consisting of (i) the separation of the placenta from the uterus, (ii) complications with the umbilical cord, (iii) combinations thereof.
The claimed subject matter of copending Application No. 17/753,229 is:
Claim 1. A method for reducing risk of preterm birth and/or a condition linked to preterm birth in female subject and/or in offspring of the female subject. The method comprises administering a composition comprising myo-inositol to the female subject. The female subject is at risk of preterm-onset pre-labor rupture of membranes (PPROM) and had a previous history of PPROM.
The claims of copending Application/Patent No. 17/753,229 do not claim instant disorder and/or condition linked to PPROM.
Ebbings teaches the placenta, membranes and umbilical cord constitute essential elements for normal development of pregnancy. Ebbings teaches in pregnancies with anomalous cord insertion (reads on umbilical cord complications) is associated with increase risk of prelabor rupture of membranes (PROM), preterm PROM (pPROM), long or short umbilical cord, and time trend of spontaneous preterm birth (SPTB) , placenta abruption. see abstract. Ebbings teaches various factors including maternal diabetes is a risk factor for PROM.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective date of the claimed invention to specifically prevent complications of the umbilical cord (a condition linked to preterm birth) . One would have been motivated to specifically treat complication of the umbilical cord since it leads to adverse complications including preterm delivery and PPROM as taught by Ebbings.
Although the claims are not identical, they are not patentably distinct from each other because, as demonstrated above in the claim sets from each application, the method of preventing PPROM and disorders and/or conditions linked to PPROM by administering a composition comprising myo-inositol to the female subject in need thereof, cited in the claims of instant Application No. 17/753,227, is obvious over the method for reducing the risk of preterm birth and/or of a condition linked to preterm birth, including a female at risk of PPROM, by administering a composition comprising myo-inositol to the female, cited in the claims of copending Application No. 17/753,229 in view of the cited secondary reference.
This is a provisional nonstatutory double patenting rejection because the patentably distinct claims have not been patented.
Response to Arguments
Applicant’s arguments are directed to the art not teaching the amended claims.
Applicant’s arguments of 2/25/2026 have been fully considered but are moot since applicant amended the claims necessitating new grounds of rejection.
Conclusion
No claims are allowed.
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 SHARMILA G. LANDAU whose telephone number is (571)272-0614. The examiner can normally be reached Monday-Friday 6-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Michener can be reached at 571-272-1424. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHARMILA G LANDAU/ Supervisory Patent Examiner, Art Unit 1653
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