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
Preliminary amendment filed on 12/19/2022 is acknowledged. Claims 1-16 were amended. Claims 1-16 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.
Information Disclosure Statement
The information disclosure statements (IDS) dated 12/19/2022 and 06/10/2024 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
Claim Objections
Claims 2-15 are objected to because of the following informalities: “Method” should be “The method” for proper antecedent basis. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 4 is 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 4 uses the phrase “available under the deposit number” which is exemplary language and considered indefinite. The language does not limit the bacteria to the strain of the deposit. Preferences, options and examples are properly set forth in the specification, but when included in the claims lead to confusion over the intended scope of the claim. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-16 are rejected 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. 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 commensurate in scope with these claims.
With respect to the claimed method, attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
All of the Wands factors have been considered and those most relevant to the cited claims are discussed below.
Nature of the invention: The invention is drawn a method for prevention of PPH and disorders and/or conditions linked to PPH in a female subject comprising administering a composition comprising myo-inositol to the female subject.
Relative skill of those in the art: The relevant art is pharmaceutical formulations, which is a mature art where practitioners receive specialized training and earn advanced degrees during the course of their study. There is a voluminous amount of published material describing research, best practices and practical application of compositions and techniques to the medical field. The relative skill of those in the art is high.
Breadth of claims: The claims are broad with respect to the concept of prevention. The full scope of the instant claims covers the entire definition of treatment and prevention as well any adverse effect from postpartum PPH and disorders and/or conditions linked to PPH in a female subject. The specification defines “prevention” as referring to the prevention of the occurrence, or reduction of the risk of the occurrence, of an unwanted condition, disorder or conditions associated with such disorders in a female subject (specification page 6). The full scope of the claims encompasses the entire definition of tertiary prevention, which covers reducing the occurrence of or eliminating a symptom or condition. The term “prevention” is assumed to take on the customary meaning known to those skilled in the art. Specifically, “prevention” is defined according to the Institute for International Medical Education (Wojtczak, 2002) as: the goals within the field of medicine to promote health, to preserve health, to restore health when it is impaired, and to minimize suffering and distress. Customarily prevention is sub-classified as primary (the protection of health by personal and community wide effects), secondary (the measures available to individuals and populations for the early detection and prompt and effective intervention to correct departures from good health) and tertiary (the measures available to reduce or eliminate long-term impairments and disabilities, minimize suffering caused by existing departures from good health, and to promote the patient's adjustment to irremediable conditions). Tertiary prevention is most relevant as used in the context of the instant invention. Thus, the intent of the method, as interpreted by a skilled practitioner of the medical or pharmaceutical arts, would include that which reduces the occurrence of, or eliminates, PPH and disorders and/or conditions linked to PPH in a female subject.
Amount of guidance/Existence of working examples: The instant specification provides experimental results administration of the myo-inositol composition to 295 women participating in the NiPPerR trial (instant specification example 2, page 20). The results showed that administration of the myo-inositol composition resulted in reduced major PPH compared to a control group that did not receive the composition (instant specification, Table 2, page 20). However, the results indicate that PPH was not completely prevented.
State of the prior art/Predictability or unpredictability of the art: Anderson et al. (American Family Physician, published 03/15/2007, see PTO-892) is drawn to the study of prevention and management of postpartum hemorrhage (title). Anderson teaches that although risk factors and preventative strategies are clearly documented, not all cases are expected or avoidable. Uterine atony is responsible for most cases. Rarely, an invasive placenta causes PPH. Further, traumatic causes such as lacerations, uterine rupture, and uterine inversion may result in PPH (abstract). Anderson teaches that risk factors for postpartum hemorrhage include a prolonged third stage of labor, multiple delivery, episiotomy, fetal macrosomia, and history of postpartum hemorrhage. However, postpartum hemorrhage also occurs in women with no risk factors (page 875).
Quantity of experimentation: One of ordinary skill in the art would have to conduct a myriad number of experiments comprising trial and error administration of the claimed composition to a female subject to determine if the claimed compositions can be used in the fully claimed scope to prevent PPH and disorders and/or conditions linked to PPH in a female subject comprising administering a composition comprising myo-inositol to the female subject. Further, as taught by Anderson, it is difficult to know who would get PPH as it also occurs in women with no risk factors. Genetech, 108 F.3d at 1366, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors as discussed above, e.g., the breadth of the claims, the amount of guidance provided, the state/unpredictability of the art and the lack of working examples, one of skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims, with no assurance of success. Claims 2-15 are rejected for being dependent on a rejected claims base.
Claims 4 and 7 are rejected under 35 U.S.C. § 112 (pre-AIA ), first paragraph or 35 U.S.C. 112(a), because 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.
It is unclear if the cell lines which produce the bacteria strains having the exact chemical identities as Lactobacillus rhamnosus GG strain CGMCC 1.3724 or the Bifidobacterium lactic BB23 strain CNCM I-3446 are known and publicly available, or can be reproducibly isolated without undue experimentation. Therefore, a suitable deposit for patent purposes is suggested. Without a publicly available deposit of the above bacteria strain lines, one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed. Exact replication of: (1) the claimed cell line; (2) a cell line which produces the chemically and functionally distinct bacteria strain claimed; and/or (3) the claimed bacteria strain is an unpredictable event.
If the deposit is made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty and that all restrictions upon public access to the deposited material will be irrevocably removed upon the grant of a patent on this application. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State.
If the deposit is not made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR 1.801-1.809 regarding availability and permanency of deposits, assurance of compliance is required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request:
(b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application:
(c) the deposits will be maintained in a public depository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and
(d) the deposits will be replaced if they should become nonviable or non-replicable.
In the instant case, the specification does not state that Lactobacillus rhamnosus GG strain CGMCC 1.3724 or the Bifidobacterium lactic BB23 strain CNCM I-3446 were deposited in any depository or that they are commercially available from any source. Therefore, it is not clear that a deposit was made under the terms of the Budapest Treaty, nor is there available a viability statement, i.e. one certifying that the deposit was viable at the time of the deposit or a certificate verifying such from the depository.
Amendment of the specification to recite the date of deposit and the complete name and address of the depository is required. As an additional means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
If a deposit is made after the effective filing date of the application for patent in the United States, a verified statement is required from a person in a position to corroborate that the biological material described in the specification as filed is the same as that deposited in the depository, stating that the deposited material is identical to the biological material described in the specification and was in the applicant's possession at the time the application was filed.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim recites “A method or use in the prevention…” which is interpreted to encompass “A method in the prevention of” and “A use in the prevention of”. The claim does not fall clearly into at least one of the four categories of patent eligible subject matter because a use claim is not considered a method for lack of distinct steps. Rather, the claims as presented can be interpreted to two distinct categories of invention: composition of matter and method. Further, "use" claims that do not clearly purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961) ("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101"). See MPEP §2173.05(q). For the purposes of applying prior art, the examiner will interpret claim 1 as a process claim.
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 1-16 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).
Regarding instant claims 3-8, 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).
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Regarding instant claim 15, 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).
Regarding instant claim 16, 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).
Regarding instant claim 14, this claim depends from instant claim 1 and recites an additional limitation to PPH. However, instant claim 1 recites the alternative limitation of a disorders and/or conditions linked to PPH. Thus, the limitation of instant claim 14 is met by the prior art teaching the treatment for GDM.
Silva does not directly teach that GDM is a condition linked to PPH. Silva does not teach that the disorder and/or condition linked to a PPH is selected from the group consisting of hypovolemia, blood transfusion, severe anemia and maternal death or mortality. 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.
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.
Conclusion
No claims allowed.
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/SAMANTHA LYNN SCHACHERMEYER/Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693