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
Claims 1-20 are pending.
Examiner has determined that the biological material Lactobacillus rhamnosus strain GG is both well-known in the art and readily available.
Priority
Acknowledgment is made of Applicant’s claim for priority to the filing date of GB1807540.8 filed 09 May 2018 and PCT/EP2019/061979 filed 09 May 2019. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The effective filing date is 09 May 2018.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 20 February 2024 is being considered by the examiner.
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 5, 15, and 20 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.
Claims 5, 15, and 20 recite the composition comprises turmeric in an amount sufficient to provide up to 50 mg total curcuminoids per serving. It is unclear what amount of the turmeric ingredient must be present in the composition to sufficiently provide up to 50 mg total curcuminoids per serving. Neither the claims nor the specification provides any specific amount or range of amounts of turmeric that would provide the up to 50 mg total curcuminoids per serving. The lack of a sufficiently defined amount of turmeric in the composition renders the claims indefinite.
Claim 6 is dependent on claim 5, and claim 16 is dependent on claim 15, so those claims are indefinite for the same reason.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 7-14, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Slykerman et al. (US 11439674 B2, effectively filed 02 June 2017) in view of Berg et al. (WO 2015164021 A1, published 29 October 2015).
Regarding claims 1, 3, and 13, Slykerman teaches a method of treating postnatal depression and postnatal anxiety in a human adult female subject in need thereof (i.e. a mother with postnatal depression or postnatal anxiety), comprising administering an effective amount of a composition comprising Lactobacillus rhamnosus probiotic (Slykerman claim 1), and a prebiotic, such as human milk oligosaccharides (Slykerman claim 16; col. 12 lns. 3-16).
However, Slykerman does not teach the composition comprises a long chain polyunsaturated fatty acid (LCPUFA) or sialyllactose.
Berg teaches a nutritional composition that comprises probiotic Lactobacillus rhamnosus GG together with human milk oligosaccharides 3’- or 6’-sialyllactose (Berg [0005]), (Berg [0001]), and long chain polyunsaturated fatty acid docosahexaenoic acid (DHA) (Berg [0006]). Berg also teaches administering their nutritional composition to a human subject promotes healthy brain function and development through the gut-brain axis (Berg Abstract and [0044]-[0047]).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to administer Berg’s probiotic composition comprising probiotic Lactobacillus rhamnosus GG, human milk oligosaccharides 3’- or 6’-sialyllactose, and long chain polyunsaturated fatty acids like docosahexaenoic acid (DHA) in Slykerman’s method of treating postnatal depression and postnatal anxiety in a subject in need thereof. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because both Slykerman’s and Berg’s compositions comprise Lactobacillus rhamnosus probiotics and human milk oligosaccharide prebiotics, and both compositions are taught to have beneficial effects on healthy human brain function. Thus, one of ordinary skill in the art would consider Berg’s composition to be suitable for administration to treat postnatal depression and postnatal anxiety in Slykerman’s method.
Regarding claims 2 and 12, Berg teaches the composition comprises 0.005-1g/100kcal of 3’- and 6’-sialyllactose (Berg [0048]). In a serving of 700-1000kcal, the amount of 3’- and 6’-sialyllactose in Berg’s composition would fall within the range of 7-10g per serving of sialyllactose in the composition used in the claimed method. Berg teaches an example composition formulation comprising 5-100 mg/100kcal (equivalent to 0.05-1mg/kcal) of long chain polyunsaturated fatty acid (LCPUFA) docosahexaenoic acid (DHA) (Berg pg. 25 Formulation Example 1). In a 150-200kcal serving, the amount of DHA in Berg’s composition would fall within the range of 150-200mg per serving of LCPUFA in the composition used in the claimed method. Berg teaches the composition comprises 1x104 CFU/100kcal to 1.5x1010 CFU/100kcal of probiotic Lactobacillus rhamnosus GG (Berg [0054]).
Regarding claims 4 and 14, the nutritional composition is taught to include vitamin D and calcium (Slykerman Col. 17, line 17; Berg [0102]-[0103]).
Regarding claims 7 and 17, the nutritional composition is taught to be in liquid or powder form (Slykerman Col. 2, line 55, Col. 8, line 67; Berg [0017]).
Regarding claims 8 and 18, the nutritional composition is taught to be a milk(dairy)-based nutritional composition (Slykerman Col. 9; Berg [0025]).
Regarding claims 9 and 19, Slykerman teaches formulating the administered composition in the form of a yogurt (Slykerman claim 4).
Regarding claim 10, Berg implicitly teaches a 100-kcal serving because throughout the disclosure Berg references concentrations of the different nutritional components per 100 kcal (for example Berg Page 25 Formulation Example 1). Berg also teaches an 8 oz. serving size (Berg [0099]).
MPEP 2144.05(I) second paragraph recites “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.")”.
In the instant case, reducing the serving amount of the liquid nutritional composition of Berg from 8 oz down to 6-7 oz would be expected by one of ordinary skill in the art to still possess the same beneficial properties and characteristics as taught by Berg, and thus would have been an obvious variation in serving size of the composition of Berg. Additionally, by reducing the 8 oz. serving size of Berg down to 6-7 oz., the caloric load of the serving would also be expected to decrease because less of the nutritional composition would be present in the serving. Therefore, because the nutritional composition of Berg anticipates the composition used in the method of claim 1 (as discussed in the 102 rejection above), the slight difference in serving size from 8 oz. taught by Berg to the 6-7 oz. of claim 10 would not be recognized by one of ordinary skill in the art to change the properties of the nutritional composition as taught by Berg.
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Slykerman and Berg as applied to claims 1-4, 7-14, and 17-19 above, and further in view of Andrews et al. (US 20160038553 A1, published February 2016), Mager et al. (US 9282758 B2, published March 2016), Maletto et al. (US 20070248696 A1, published October 2007), and as evidenced by Institute of Medicine (IOM (Institute of Medicine). 2011. Dietary Reference Intakes for Calcium and Vitamin D. Washington, DC: The National Academies Press, Summary Tables, Dietary Reference Intakes, Pages 1103-1115).
Slykerman and Berg do not teach adding fenugreek into their nutritional composition.
However, Andrews teaches adding about 500mg to 2000mg of fenugreek to a nutritional composition and that adding fenugreek into a nutritional composition can aid in inducing and increasing lactation in lactating mothers (Andrews [0006]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to add 500mg to 2000mg of fenugreek as taught by Andrews into the nutritional composition of Berg, and administer the composition in Slykerman’s method of treating postnatal depression and postnatal anxiety. One of ordinary skill in the art would have been motivated to do so because Andrews taught that adding 500mg to 2000mg of fenugreek to a nutritional composition can induce and increase lactation in lactating mothers, and thus by adding fenugreek the nutritional composition of Berg would have the added advantage of being able to induce and increase lactation to the subject consuming the composition.
Slykerman, Berg, and Andrews do not teach the addition of turmeric into the nutritional composition.
However, Mager also teaches that turmeric can be added into a composition to add antioxidative properties (Mager col. 27 lines 28-39).
Mager does not teach how much turmeric is added into the composition.
MPEP 2144.05 (II)(A) states: “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”. Additionally, MPEP 2144.05 (II)(B) states: “[i]n order to properly support a rejection on the basis that an invention is the result of "routine optimization", the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017)”.
Adjusting the concentrations of turmeric in the composition to concentrations known in the art was well within the purview of one of ordinary skill in the art. Maletto teaches a composition comprising turmeric in an amount from 5 mg to 1000 mg (Maletto claim 6), which overlaps with the instant range, and that turmeric offers beneficial antioxidant, antitumor, anti-amyloid, and anti-inflammatory properties (Maletto [0028]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to add turmeric to the composition of Berg in an amount ranging from 5 to 1000mg as taught by Mager and Maletto, and administer the composition in Slykerman’s method of treating postnatal depression and postnatal anxiety. One of ordinary skill in the art would have been motivated to do so because turmeric was taught by Mager and Maletto to be useful for adding antioxidative properties to compositions, and Maletto taught a composition comprising an effective amount of turmeric, 5-1000mg.
Slykerman, Berg, Andrews, Mager, and Maletto do not explicitly teach a specific amount of calcium or vitamin D present in its nutritional composition.
However, Berg does teach that the vitamins and minerals of the nutritional composition, including vitamin D and calcium, may be added in amounts sufficient to supply the daily nutritional requirements of a subject (Berg [0101]). Calcium has an average Recommended Dietary Intake range of 200 to 1300 mg/day, as evidenced by Institute of Medicine (IOM Page 1108 Column Calcium). Vitamin D has an average Recommended Dietary Intake range of 10 to 20 mcg/day, which is equivalent to 400-800 IU per day, as evidenced by Institute of Medicine (IOM Page 1106 Column Vitamin D and footnote b). The Tolerable Upper Intake level of vitamin D ranges from 25-100 mcg/day, which is equivalent to 1000 to 4000 IU per day, as evidenced by Institute of Medicine (IOM Page 1112 Column Vitamin D).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to adjust the concentration of vitamin D and calcium in the nutritional composition of Berg to be in accordance with the average Recommended Dietary Intake ranges and Tolerable Upper Intake levels of vitamin D and calcium as evidenced by Institute of Medicine. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Berg taught that the vitamins and minerals of the nutritional composition, including vitamin D and calcium, may be added in amounts sufficient to supply the daily nutritional requirements of a subject (Berg [0101]), and thus one of ordinary skill in the art would have been motivated to adjust the amounts of vitamin D and calcium to match the daily nutritional requirements of a subject.
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Slykerman, Berg, Andrews, Mager, and Maletto as applied to claims 5 and 15 above, and further in view of King et al. (US 9339453 B2, published May 2016).
Slykerman, Berg, Andrews, and Maletto do not teach adding nut extracts into the nutritional composition.
Mager teaches a nutritional composition comprising sialyllactose, DHA, and Lactobacillus rhamnosus GG, and also teaches that nuts, like walnuts and almonds, are exemplary sources of omega-3 fatty acids such as docosahexaenoic acid (DHA) (Mager Col. 2 lines 20-26).
Mager does not teach a nut extract, nor an amount of nut extract to add to the nutritional composition.
King teaches a composition comprising a nut extract in a range from 1 gram to 36 grams (King bridging paragraph from column 6 to 7), which is equivalent to 0.035 to 1.27 oz., and thus overlaps with the instant range of up to 1.5 oz. nut extract per serving.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to add 0.035 to 1.27 oz. of nut extract as taught by Mager and King into the nutritional composition taught by Slykerman, Berg, Andrews, Mager, and Maletto, and administer the composition in Slykerman’s method of treating postnatal depression and postnatal anxiety. One of ordinary skill in the art would have been motivated to do so because nuts and their extracts like those of walnuts and almonds were taught by Mager and King to be useful sources of DHA, an ingredient present in the nutritional composition of Berg. Thus, one of ordinary skill in the art would find it advantageous to use nut extracts as sources of DHA in the composition of Berg.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Slykerman et al. (US 11439672 B2, effectively filed 02 June 2017), Berg et al. (WO 2015164021 A1, published 29 October 2015), Andrews et al. (US 20160038553 A1, published February 2016), Mager et al. (US 9282758 B2, published March 2016), Maletto et al. (US 20070248696 A1, published October 2007), and King et al. (US 9339453 B2, published May 2016), and as evidenced by Institute of Medicine (IOM (Institute of Medicine). 2011. Dietary Reference Intakes for Calcium and Vitamin D. Washington, DC: The National Academies Press, Summary Tables, Dietary Reference Intakes, Pages 1103-1115).
Slykerman teaches a method of treating postnatal depression and postnatal anxiety in a human adult female subject in need thereof (i.e. a mother with postnatal depression or postnatal anxiety), comprising administering an effective amount of a composition comprising Lactobacillus rhamnosus probiotic (Slykerman claim 1), and a prebiotic, such as human milk oligosaccharides (Slykerman col. 12 lns. 3-16). The nutritional composition may include vitamin D and calcium (Slykerman Col. 17, line 17;
in liquid or powder form (Slykerman Col. 2, line 55, Col. 8, line 67) and may be a dairy-based product (Slykerman Col. 9).
However, Slykerman does not teach the composition comprises a long chain polyunsaturated fatty acid (LCPUFA), sialyllactose, fenugreek, turmeric, or nut extract, nor serving sizes of those components.
Berg teaches a nutritional composition that comprises human milk oligosaccharides 3’- or 6’-sialyllactose (Berg [0005]), probiotics such as Lactobacillus rhamnosus GG (Berg [0001]), and long chain polyunsaturated fatty acids like docosahexaenoic acid (DHA) (Berg [0006]). Berg also teaches the administration of the nutritional composition to a human subject, which promotes health brain function and development through the gut-brain axis (Berg Abstract and [0044]-[0047]). Berg teaches the composition comprises 0.005-1g/100kcal of 3’- and 6’-sialyllactose (Berg [0048]). In a serving of 700-1000kcal, the amount of 3’- and 6’-sialyllactose in Berg’s composition would fall within the range of 7-10g per serving of sialyllactose in the composition used in the claimed method. Berg teaches an example composition formulation comprising 5-100 mg/100kcal (equivalent to 0.05-1mg/kcal) of long chain polyunsaturated fatty acid (LCPUFA) docosahexaenoic acid (DHA) (Berg pg. 25 Formulation Example 1). In a 150-200kcal serving, the amount of DHA in Berg’s composition would fall within the range of 150-200mg per serving of LCPUFA in the composition used in the claimed method. Berg teaches the composition comprises 1x104 CFU/100kcal to 1.5x1010 CFU/100kcal of probiotic Lactobacillus rhamnosus GG (Berg [0054]). Berg also teaches the nutritional composition may comprise vitamin D and calcium (Berg [0102]-[0103]).
However, Slykerman and Berg do not teach adding fenugreek into their nutritional composition.
Andrews teaches adding about 500mg to 2000mg of fenugreek to a nutritional composition and that adding fenugreek into a nutritional composition can aid in inducing and increasing lactation in lactating mothers (Andrews [0006]).
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to add 500mg to 2000mg of fenugreek as taught by Andrews into the nutritional composition of Berg , and administer the composition in Slykerman’s method of treating postnatal depression and postnatal anxiety. One of ordinary skill in the art would have been motivated to do so because Andrews taught that adding 500mg to 2000mg of fenugreek to a nutritional composition can induce and increase lactation in lactating mothers, and thus by adding fenugreek the nutritional composition of Berg would have the added advantage of being able to induce and increase lactation to the subject consuming the composition.
However, Slykerman, Berg and Andrews do not teach the addition of turmeric into the nutritional composition.
Mager teaches that turmeric can be added into a composition to add antioxidative properties (Mager col. 27 lines 28-39).
Slykerman, Berg, Andrews, and Mager do not teach how much turmeric is added into the composition.
MPEP 2144.05 (II)(A) states: “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”. Additionally, MPEP 2144.05 (II)(B) states: “[i]n order to properly support a rejection on the basis that an invention is the result of "routine optimization", the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017)”.
Adjusting the concentrations of turmeric in the composition to concentrations known in the art was well within the purview of one of ordinary skill in the art. Maletto teaches a composition comprising turmeric in an amount from 5 mg to 1000 mg (Maletto claim 6), which overlaps with the instant range, and that turmeric offers beneficial antioxidant, antitumor, anti-amyloid, and anti-inflammatory properties (Maletto [0028]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to add turmeric to the composition of Berg in an amount ranging from 5 to 1000mg as taught by Mager and Maletto , and administer the composition in Slykerman’s method of treating postnatal depression and postnatal anxiety. One of ordinary skill in the art would have been motivated to do so because turmeric was taught by Mager and Maletto to be useful for adding antioxidative properties to compositions, and Maletto taught a composition comprising an effective amount of turmeric, 5-1000mg.
Slykerman, Berg, Andrews, Mager, and Maletto do not explicitly teach a specific amount of calcium or vitamin D present in its nutritional composition.
However, Berg does teach that the vitamins and minerals of the nutritional composition, including vitamin D and calcium, may be added in amounts sufficient to supply the daily nutritional requirements of a subject (Berg [0101]). Calcium has an average Recommended Dietary Intake range of 200 to 1300 mg/day, as evidenced by Institute of Medicine (IOM Page 1108 Column Calcium). Vitamin D has an average Recommended Dietary Intake range of 10 to 20 mcg/day, which is equivalent to 400-800 IU per day, as evidenced by Institute of Medicine (IOM Page 1106 Column Vitamin D and footnote b). The Tolerable Upper Intake level of vitamin D ranges from 25-100 mcg/day, which is equivalent to 1000 to 4000 IU per day, as evidenced by Institute of Medicine (IOM Page 1112 Column Vitamin D).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to adjust the concentration of vitamin D and calcium in the nutritional composition of Berg to be in accordance with the average Recommended Dietary Intake ranges and Tolerable Upper Intake levels of vitamin D and calcium as evidenced by Institute of Medicine. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Berg taught that the vitamins and minerals of the nutritional composition, including vitamin D and calcium, may be added in amounts sufficient to supply the daily nutritional requirements of a subject (Berg [0101]), and thus one of ordinary skill in the art would have been motivated to adjust the amounts of vitamin D and calcium to match the daily nutritional requirements of a subject.
Slykerman, Berg, Andrews, and Maletto do not teach adding nut extracts into the nutritional composition.
Mager teaches a nutritional composition comprising sialyllactose, DHA, and Lactobacillus rhamnosus GG, and also teaches that nuts, like walnuts and almonds, are exemplary sources of omega-3 fatty acids such as docosahexaenoic acid (DHA) (Mager Col. 2 lines 20-26).
However, Slykerman, Berg, Andrews, Mager, and Maletto do not teach a nut extract, nor an amount of nut extract to add to the nutritional composition.
King teaches a composition comprising a nut extract in a range from 1 gram to 36 grams (King bridging paragraph from column 6 to 7), which is equivalent to 0.035 to 1.27 oz., and thus overlaps with the instant range of up to 1.5 oz. nut extract per serving.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to add 0.035 to 1.27 oz. of nut extract as taught by Mager and King into the nutritional composition taught by Slykerman, Berg, Andrews, Mager, and Maletto, and administer the composition in Slykerman’s method of treating postnatal depression and postnatal anxiety. One of ordinary skill in the art would have been motivated to do so because nuts and their extracts like those of walnuts and almonds were taught by Mager and King to be useful sources of DHA, an ingredient present in the nutritional composition of Berg. Thus, one of ordinary skill in the art would find it advantageous to use nut extracts as sources of DHA in the composition of Berg.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER M DURYEE whose telephone number is (571)272-9377. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/Alexander M Duryee/Examiner, Art Unit 1657
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657