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 .
DETAILED ACTION
This Office Action is responsive to Applicant’s amendment and remarks, filed on 06/05/2026 in which claims 1, 8, and 11-16 were amended, claims 2-7 and 9-10 were cancelled, and claims 17-22 were newly added. Claims 1, 8, and 11-22 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/EP2021/067015, filed on 06/22/2021 and claims foreign priority to European Patent Office (EPO) 20181450.6 filed on 06/22/2020.
Withdrawn Objections
Applicant’s amendment, filed on 06/05/2026, with respect to the objection of claims 2-15 has been fully considered and is persuasive. Applicant has cancelled 2-10 and amended claims 11-15 to be “A method”. The objection is hereby withdrawn.
Withdrawn Rejections
Applicant’s amendment, filed on 06/05/2026, with respect to the rejection of claim 4 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 has been fully considered and is persuasive. Applicant has canceled claim 4 rendering the rejection moot. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 06/05/2026, with respect to the rejection of claims 1-16 under 35 U.S.C. 112(a), because the specification, while being enabling for inhibiting, decreasing or reducing the occurrence of postpartum hemorrhage (PPH) and disorders and/or conditions linked to PPH in a female subject, it does not reasonably provide enablement for preventing PPH and disorders and/or conditions linked to PPH in a female subject, has been fully considered and is persuasive. Applicant has amended independent claim 1 to replace the phrase “prevention” with “inhibiting, decreasing or reducing the occurrence”. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 06/05/2026, with respect to the rejection of claims 4 and 7 under 35 U.S.C. 112(a), the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention, because the specification does not provide evidence that the claimed biological materials are (1) known and readily available to the public; (2) reproducible from the written description, has been fully considered and is persuasive. Applicant has canceled claims 4 and 7 rendering the rejection moot. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 06/05/2026, with respect to the rejection of claims 1 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter, has been fully considered and is persuasive. Applicant has amended claim 1 to replace the phrase “a method or use in the prevention” to “A method for inhibiting, decreasing or reducing the occurrence of post-partum haemorrhage…”. The rejection is hereby withdrawn.
Applicant’s amendment, filed on 06/05/2026, with respect to the rejection of claims 2-7 and 9-10 under 35 U.S.C. 103 as being unpatentable Silva et al. (WO 2016/020495 A1, published 02/11/2016, IDS dated 12/19/2022) and Muche et al. (BMC Pregnancy and Childbirth, published 02/03/2020, IDS dated 12/19/2022), has been fully considered and is persuasive. Applicant has canceled claims 2-7 and 9-10, rendering the rejections moot. The rejection is hereby withdrawn.
Rejections Necessitated by Amendment
The following are new ground(s) necessitated by Applicants' amendment, filed on 06/05/2026, wherein instant independent claim 1 was amended to alter the breadth and scope of the claim and wherein the remaining pending claims 8 and 11-22 depend from said independent claim 1.
Modified and New Grounds of Rejection
Claim Rejections - 35 USC § 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, 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, 8, and 11- 22 are rejected under 35 U.S.C. 103 as being unpatentable over Silva et al. (WO 2016/020495 A1, published 02/11/2016, see IDS dated 12/19/2022) and Muche et al. (BMC Pregnancy and Childbirth, published 02/03/2020, see IDS dated 12/19/2022).
Silva is drawn to a maternal nutrition composition comprising myoinositol and probiotics. The composition has been specifically designed to provide optimized nutrition to a woman desiring to get pregnant, to a pregnant woman and/or to a lactating woman. Silva teaches the use of a combination of myo-inositol and one or more probiotics to treat gestational diabetes mellitus (GDM) and conditions associated with GDM in a pregnant subject or a subject desiring to become pregnant wherein the combination of myo-inositol and one or more probiotics is administered to said subject before and/or during pregnancy and/or during lactation (abstract). Silva exemplifies a composition comprising myoinositol, lactobacillus rhamnosus strain deposited as CGMCC 1.3724 and bifidobacterium lactis strain CNCMI-3446. The composition further comprises vitamin B2, vitamin B6, Vitamin B12, Vitamin D, and zinc. The components are in the amounts listed in the table below (Table 1, page 27). The amounts are per daily dose (page 12, line 4) which meets the limitations of instant claim 1 of a composition comprising 0.2 to 5 g myoinositol, 0.14 to 14 mg vitamin B2, 0.19 to 19 mg vitamin B6, 0.26 to 25 µg vitamin B12, 1.5 to 100 µg vitamin D, 105 to 1012 cfu Bifidobacterium lactis BB23 CNCMI-3446, and 105 to 1012 cfu Lactobacillus rhamnosus GG CGMCC 1.3724.
PNG
media_image1.png
57
808
media_image1.png
Greyscale
PNG
media_image1.png
57
808
media_image1.png
Greyscale
Silva teaches that composition can be in any form that is suitable to administer all the ingredients to the woman. For example, it can be in the form of a powdered nutritional composition to be reconstituted in milk or water, a food product, a functional food product, a drink, (beverage), a dairy product, a pharmaceutical formulation, a pet food product, a nutritional supplement or a nutraceutical (page 13, lines 1-5). Silva teaches that all ingredients of the composition can be mixed together or alternatively the composition can be provided in the form of a kit of parts wherein ingredients or groups of ingredients are provided separately and are intended to be consumed together by the woman (page 16, lines 28-30). The kit of parts comprises a first composition comprising myo-inositol and at least one vitamin selected from vitamin B2, vitamin B6, vitamin B12, vitamin D and mixtures thereof, optionally with other vitamins and/or nutrients listed in Table 1 above, except probiotics, and a second composition comprising probiotics. In a most preferred embodiment, the kit of parts comprises a first composition comprising myo-inositol, vitamin B2, vitamin B6, vitamin B12, vitamin D and zinc and a second composition comprising probiotics (page 15, lines 1-20).
Silva does not directly teach that GDM is a condition linked to PPH. Silva does not directly teach the administration of the composition to a subject at risk of PPH.
Muche is drawn to the study of the effects of GDM on the risk of adverse maternal outcomes (title). Muche teaches that GDM is a leading medical condition woman encounter during pregnancy with serious short- and long-term consequences for maternal morbidity. Muche teaches that women with GDM had a higher risk of compositing adverse maternal outcome including PPH compared to women without GDM (abstract). Muche further teaches that GDM can result in a higher maternal morbidity. Muche defines PPH to be a blood loss of 500 mL or more within 24 hours after birth meeting the limitation of primary PPH.
It would have been prima facie obvious to combine the teachings of Silva and Muche before the effective filing date by administering the composition comprising myoinositol, lactobacillus rhamnosus bifidobacterium, vitamin B2, vitamin B6, vitamin B12, vitamin D, and zinc to a woman with GDM as taught by Silva which is a disorder or condition linked to PPH and increased maternal morbidity as taught by Muche to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to administer the composition of the instant invention to treat a condition linked to PPH because Silva teaches the administration of the instant composition to treat GDM and conditions associated with GDM and Muche teaches that GDM is associated with increased risk of PPH. One of ordinary skill in the art would have a reasonable expectation of success because Silva teaches the administration of the instant composition to treat GDM and conditions associated with GDM and Muche teaches that GDM is associated with increased risk of PPH and maternal morbidity.
Response to Arguments
Applicant's arguments filed 06/05/2026 have been fully considered but they are not persuasive.
Applicant argues that the combined teachings of Silva and Muche do not teach the treatment of PPH and that at most, Muche teaches the management of obstetric hemorrhage in the specific patient population of women with GDM. The argument is not persuasive. Muche establishes that women with GDM are 5x more likely to experience PPH and therefore, it would be logical that reducing GDM would reduce the occurrence of PPH.
Applicant argues that the applicant's specification demonstrates that treating female subjects with the claimed composition resulted in the unexpected superior benefit of treating or preventing PPH. For example, Examples 2 and 4 in the Specification demonstrate a significant statistical reduction in the risk of major PPH with the claimed intervention. These results adjust for all measurable covariates, including 28 weeks' gestation (fasting glucose)- distinguishing the GDM of Muche. The significant reduction in PPH is not achieved through preventive action on blood glucose level, but, rather, through the administering to the female subject the claimed composition. The argument is unpersuasive. The instant specification does not establish a statistical difference between the reduction of PPH and the reduction of GDM. The instant specification includes indicates that there is a statistically significant reduction in major PPH when compared to adjusted model 2 that includes multiple covariates such as fasting glucose at pregnancy week 28, site and ethnicity, offspring’s sex, maternal age, educational/income level, parity, smoking during pregnancy, and maternal pre-conception BMI, but the data was provided only for the entire grouping of the covariates making any distinction between fasting glucose at pregnancy week 28 and PPH indiscernible from the instant specification. Further, fasting glucose at pregnancy week 28 level alone does not determine GDM. In Muche, a clinical diagnosis of GDM was determined by a universal screening for GDM using a two-hour 75 g oral glucose tolerance test (page 3).
Applicant argues that the administration of the claimed composition had the unexpected benefit of decreasing several risk factors for PPH, namely delay in second stage labor and epidural labor. See Specification, Example 3 and Table 3. The argument is unpersuasive. As the teachings of Silva teach the same actives at the same concentration and with the same population of pregnant women and women trying to become pregnant as instantly claimed, the results would necessarily flow. The instantly claimed results are merely a mechanism of action resulting from the administration step. MPEP 2112(II) makes clear that there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Furthermore, MPEP 2145 states that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. Applicant’s recitation of a new mechanism of action for the prior art method would not, by itself, distinguish the instant claims over the prior art teaching the same or nearly the same method steps.
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.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA SCHACHERMEYER whose telephone number is (703) 756-5337. The examiner can normally be reached on M-F 9:00 AM – 3:30 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on (571) 270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center and the Private Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from Patent Center or Private PAIR. Status information for unpublished applications is available through Patent Center and Private PAIR to authorized users only.
Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/S.L.S./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
Prosecution Insights