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 .
Claims 1-17 are pending in the application.
Election/Restrictions
Applicant’s election without traverse of ingredients myo-inositol, probiotics, vitamin B2, vitamin B6 or Vitamin B12, as the further component in the reply filed on June 5, 2026 is acknowledged.
Claims 5, 12, and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 6, 2026.
Claims 1-17 are pending in the application. Claims 5, 12, and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-4, 6-11, and 14-17 will presently be examined to the extent they read on the elected subject matter of record.
Priority
This application is a National Stage Entry of PCT/EP2022/084813 filed December 7, 2022, which claims benefit to U.S. Provisional Application No. 63/287,782 filed December 9, 2021 and U.S. Provisional Application No. 63/353,991 filed June 21, 2022.
Information Disclosure Statement
Receipt of Information Statements filed June 7, 2024 is acknowledged.
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 2, 10 and 11 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 2, line 2 recites “from before pregnancy of the subject”. The use of the term “from” indicates that there is a range. For example, “from before pregnancy to the subject until the subject gives birth”. Applicant should clarify the metes and bounds of the claim.
Claim 2 is being interpreted as “wherein the nutritional composition is administered to the subject before pregnancy of the subject”.
Claim 10 recites “the nutritional composition is administered in a daily dose comprising between about 0.2 g and about 11 g myo-inositol; between about 105 and about 1012 colony forming units (cfu) probiotics comprising B. Lactis and LPR; between about 0.14 mg and about 14 mg vitamin B2; between about 0.19 mg and about 19 mg vitamin B6; and/or between about 0.26 µg and about 26 µg vitamin B12” in lines 3-8. Claim 10 is dependent from claim 1. Claim 1 recites the nutritional composition comprising: at least one of vitamin D or zinc. Claim 1 does not recite myo-inositol; probiotic comprising B. Lactis and LPR; vitamin B2; vitamin B6; and vitamin B12. As such, there is lack of antecedent basis for these limitations in claim 10.
Claim 11 recites “the nutritional composition is administered in a daily dose comprising in a daily dose comprising about 4 g myo-inositol; about 109 cfu probiotics comprising B. Lactis and LPR; about 1.8 mg vitamin B2; about 2.6 mg vitamin B6; and/or about 5.2 µg vitamin B12” in lines 3-7. Claim 11 is dependent from claim 1. Claim 1 recites the nutritional composition comprising: at least one of vitamin D or zinc. Claim 1 does not recite myo-inositol; probiotic comprising B. Lactis and LPR; vitamin B2; vitamin B6; and vitamin B12. As such, there is lack of antecedent basis for these limitations in claim 10.
Claims 10 and 11 recite LPR in lines 5 and 4, respectively. It is unclear the meaning of LPR. It is not an art recognized term. In reviewing the specification, the probiotic combination is Lactobacillus and Bifidobacterium. In one embodiment, the Lactobacillus strain may be the Lactobacillus rhamnosus GG strain available under the deposit number CGMCC 1.3724. The Bifidobacterium strain may be the Bifidobacterium lactis BB12 strain deposited as CNCM 1-3446. Applicant should clarify the meaning of LPR. LPR is being interpreted and will be examined as Lactobacillus rhamnosus.
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.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4, 6, 8, 14, 15, and 16 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Perrin et al. (US 2017/0112178). Perrin et al. cited by Applicant on the IDS dated June 7, 2024.
Perrin et al. disclose a method of improving a nutritional status in a prenatal, pregnant, or breastfeeding patient. The method includes providing a pharmaceutical composition in a single oral dosage form for administration to prenatal, pregnant or breastfeeding patient. The pharmaceutical composition consists of Vitamin D, Vitamin B1, vitamin B6, vitamin B12, zinc…and one or more pharmaceutically acceptable carriers (Abstract).
Regarding claims 1, 4, 6, 8, 14, 15, and 16, Perrin et al. teach a study was undertaken testing supplementation of iron and vitamin D. In the first group, each subject is administered 1 gelcap daily, with the composition as described in Example 1. The subjects were pregnant women entering the second trimester (page 21, paragraph
177). Example 1 comprises:
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(page 20, paragraph 166).
An assessment of nutritional status of each subject is measured at one-month intervals for a six month period (page 21, paragraph 179).
Regarding the limitation of increasing at least one micronutrient level in breastmilk of a subject, Perrin et al. disclose a statistically significant improvement in the nutritional status is preferably observed in the treated subjects who are administered the composition of Example 1 over treated subjects who are administered the controls. Specifically, in regard to vitamin D supplementation, the tested serum levels of 25-hydroxyvitamin D are preferably in the range of 30 ng/ml for treated subjects (page 22, paragraph 180).
Perrin et al. meet all the limitations of the claims and thereby anticipate the claims.
Claims 1, 2, 3, 4, 6, 8, 9, 14, 15, and 17 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Rochat et al. (WO 2017/037105).
Rochat et al. disclose a composition comprising B. longum ATCC BAA-999 for use in an individual to support breastfeeding initiation and/or to optimize breastfeeding duration (Abstract). B. longum ATCC BAA-999 is a probiotic.
Regarding claim 1, 4, 6, 8, and 9, Rochat et al. disclose in Example 3, an example composition comprising Bifidobacterium lactis BB122 (probiotic) further combined within vitamins, minerals and myo-inositol (myo-inositol) is set out in table 1. The composition in Table 1 is for a nutritional supplement in a powder from, intended to be sprinkled on food (page 28, lines 8-11).
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Regarding claims 2, 3, 14, 17, Rochat et al. disclose that B. longum ATCC BAA-999 or composition comprising B. longum ATCC BAA-999 may be administered at any time during the prenatal period, e.g. pre-pregnancy to an individual trying to get pregnant, to a pregnant individual or to an individual that has had a baby e.g. a lactating individual (page 2, lines 21-24).
Rochat et al. disclose the composition comprising B. longum ATCC BAA-999 may further comprise an ingredient selected from the group consisting of a vitamin and myo-inositol (page 3, lines 6-8).
Regarding claim 15, Rochat et al. disclose “individual” and “patient” are understood to include an animal, especially a mammal trying to get pregnant, pregnant or lactating, and more especially a human trying to get pregnant, a pregnant human or a human that has given birth e.g. a lactating human (page 7, lines 10-13).
Rochat et al. disclose with respect to the optimization of the quality of breast milk, the term optimize can mean to improve the composition of breastmilk and for example to bring it in line or closer to the composition of breastmilk produced by an individual that is not or has not suffered from peripartum emotional distress (page 8, lines 18-21).
Rochat et al. disclose administration to an individual desiring to get pregnant may be at any time during which an individual is trying to become pregnant, however, ordinarily administration will be during at least the 12 months preceding the pregnancy or desired pregnancy and more particularly 1, 2, 3, or 4 months preceding the pregnancy or desired pregnancy (page 11, lines 30-31-page 12, lines 1-2).
Rochat et al. disclose the composition comprising B. longum ATCC BAA-999 may also comprise myo-inositol (page 17, line 25). The food grade bacteria may be selected from the group consisting of lactic acid bacteria, bifidobacteria (page 18, lines 1-2).
Rochat et al. disclose the food grade bacteria can comprise another/additional probiotic bacteria, although in some embodiments the B. longum ATCC BAA-999 is the only probiotic bacteria in the composition (page 18, lines 6-7).
Rochat et al. disclose non-limiting examples of suitable probiotic bacteria include Bifidobacterium, Bifidobacterium lactis, Lactobacillus rhamnosus, Lactobacillus rhamnosus GG (ATCC53103) and mixtures thereof (page 18, lines 17-27).
Rochat et al. disclose the composition is a nutritionally complete formula (page 20, line 1).
Rochat et al. meet all the limitations of the claims and thereby anticipate the claims.
Claim Rejections - 35 USC § 102/Claim Rejections - 35 USC § 103
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
Claim(s) 1, 2, 3, 4, 6, 7, 8, 9, 10, 11, 14, 15, and 17 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Silva Zolezzi et al. (WO 2016/020491).
Silva Zolezzi et al. disclose in Example 4, a composition comprising a combination of myo-inositol and probiotics (Lactobacillus rhamnosus GG1 and Bifidobacterium lactis BB122) further combined with vitamin B2 and vitamins B6, B12, and D, is set out in table 4 (page 18, lines 440-443).
Regarding claim 1, 3, 4, 6, 8, 9, 10, 11, and 15, Silva Zolezzi et al. disclose the composition in table 4 is for a nutritional supplement in a powder form, intended to be sprinkled on food and administered to a pregnant mother or mother via whom the ingredients, in particular myo-inositol and probiotics, are administered in-utero or via breast milk to an infant (page 18, lines 445-448).
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Silva Zolezzi et al. disclose the in-utero administration of a combination of myo-inositol and probiotics may result in a lower body weight and higher % lean mass in an infant (page 2, lines 37-39).
Regarding claim 2, 14, and 17, Silva Zolezzi et al. disclose the myo-inositol and probiotics may also be administered pre-pregnancy; this may positively impact the intrauterine environment. The myo-inositol and probiotics may be administered to a women desiring to get pregnant, for example during at least 1, 2, 3, or 4 months preceding the pregnancy or desired pregnancy (page 9, lines 231-234).
Regarding claim 3, Silva Zolezzi et al. disclose the myo-inositol and probiotics may be administered simultaneously, separately or sequentially to said infant in-utero. The administration may be via the pregnant mother. The administration may continue after birth. Administration to the infant after birth may be directly to the infant and/or via the mother in the mother’s breast milk (page 2, lines 43-46).
Regarding claim 7, Silva Zolezzi et al. disclose administration after birth may for example continue until the infant is 12 months of age (page 2, lines 46-47).
Silva Zolezzi et al. disclose the probiotic preferably comprises a combination of Lactobacillus and Bifidobacterium, in particular the Lactobacillus is Lactobacillus rhamnosus GG strain and/or the Bifidobacterium is the Bifidobacterium lactis BB12 strain (page 2, lines 49-52).
Silva Zolezzi et al. disclose if the myo-inositol and probiotics are administered to an infant in-utero via the pregnant mother, and optionally after birth via the mother’s breast milk, they may be administered to said pregnant mother or mother in one or more composition suitable for maternal administration, for example they may be administered in the form of a powdered nutritional composition, a food product, a functional food product, a nutritional supplement (page 6, lines 159-166).
Silva Zolezzi et al. disclose if the myo-inositol and probiotics are for administration to an infant after birth via the mother’s breast milk, the myo-inositol may be administered partly or completely throughout the lactation or breastfeeding period of the mother (page 8, lines 227-229).
Silva Zolezzi et al. disclose micronutrients in the following amounts may be useful when employed in combination with the myo-inositol and probiotics for the use herein: 1.4 to 40 mg zinc…0.14 to 14 mg Vitamin B1; in particular these doses are administered to a pregnant mother or a mother, via whom the myo-inositol and probiotics are administered in-utero or via breast milk to the infant (page 11, lines 302-310).
Silva Zolezzi et al. do not specifically disclose increasing at least one micronutrient level in breastmilk of a subject. However, it would have been obvious to one of ordinary skill in the art that Silva Zolezzi et al. disclose the same method that is currently claimed, administration of at least one vitamin D or zinc, as exemplified in Example 4, to a subject. Silva Zolezzi et al. further disclose the administration of vitamin D and zinc with myo-inositol, probiotics, Lactobacillus rhamnosus GG strain and Bifidobacterium lactis, vitamin B2, vitamin B6, and vitamin B12, within the same concentrations as claimed in claims 9, 10, and 11. As such, following the prior art teaching that if the same composition comprising vitamin D, zinc, myo-inositol, probiotics, vitamin B2, vitamin B6, and vitamin B12 administered to a subject prior to pregnancy, during pregnancy and after pregnancy through breast milk, is taught in the prior art, the skilled artisan would expect to obtain a result that necessarily flows with the intended purpose and properties, i.e., increase in at least one micronutrient level in breastmilk, without evidence to the contrary.
In addition, the reason or motivation to modify a reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. While there must be motivation to make the claimed invention, there is no requirement that the prior art provide the same reason as the applicant to make the claimed invention.
Silva Zolezzi et al. meet all the limitations of the claims and thereby anticipate and are obvious over the claims.
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 1-4, 6, 8, 9-11, 14, 15, and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 6, 7, 8, 11, 12, and 15 of copending Application No. 19/128,422 (‘422). Although the claims at issue are not identical, they are not patentably distinct from each other because each is drawn to administration of a composition comprising myo-inositol, a combination of Lactobacillus and Bifidobacterium probiotics, vitamin B2, vitamin B6, vitamin B12, vitamin D and mixtures thereof (claims 1, 4, 10, and 11, instant invention; claims 1 and 5, copending Application No. ‘422). Each claims the composition is administered before pregnancy, until the subject gives birth, and lactation (claims 2, 3, 14, 17, instant invention; claims 1 and 12, copending Application No. ‘422). Each claims the subject is a mammal, a cat, a dog or a human (claim 15, instant invention; claims 11 and 15, copending Application No. ‘422). Each claims the composition comprises zinc (claims 1 and 6, instant invention; claim 7, copending Application No. ‘422). Each claims the concentration of the components of the compositions (claims 9, 10, and 11, instant invention; claims 6 and 8, copending Application No. ‘422). Copending Application No. ‘422 does not specifically disclose the method increases at least one micronutrient level in breast milk of a subject. However, it would have been obvious to one of ordinary skill in the art that copending Application No. ‘422 discloses the same method that is currently claimed, administration of at least one vitamin D or zinc, with myo-inositol, probiotics B. Lactis and LPR, vitamin B2, vitamin B6, and vitamin B12, within the same concentrations as claimed in claims 9, 10, and 11. As such, following the prior art teaching that if the composition comprising vitamin D, zinc, myo-inositol, probiotics, vitamin B2, vitamin B6, and vitamin B12 administered to a subject prior to pregnancy, during pregnancy and after pregnancy through breast milk, is disclosed in copending Application No. ‘422, the skilled artisan would expect to obtain a result that necessarily flows with the intended purpose and properties, i.e., increase in at least one micronutrient level in breastmilk, without evidence to the contrary. For these reasons, one of ordinary skill in the art would found the instant invention obvious over the claims of copending application ‘422.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andriae M Holt whose telephone number is (571)272-9328. The examiner can normally be reached Monday-Friday, 8:00 am-4:30 pm EST.
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/ANDRIAE M HOLT/ Examiner, Art Unit 1614
/ALI SOROUSH/ Supervisory Patent Examiner, Art Unit 1614
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