DETAILED ACTION
Claims 1-3 are pending and examined.
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 .
Claim Objections
Claims 1 and 3 are objected to because of the following informalities:
In claim 1, the acronym “NRF” should be replaced by the full name the first time it appears followed by the abbreviation in parentheses, i.e. (NRF). The phrase “NRF mitochondria” is an incoherent and should be replaced with “mitochondrial NRF”. The phrase “salvia miltiorrhiza” should be italicized and replaced with “Salvia miltiorrhiza”.
Claim 3 is objected to because momordica charantia, fructus mume and rhodiola rosea should be replaced with Momordica charantia, Fructus mume and Rhodiola rosea.
Appropriate correction is required.
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 1-3 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
The claims recite a composition comprising a Salvia miltiorrhiza extract, a wheat α-amylase inhibitor, Bifidobacterium animalis subsp. Lactis, and Lactobacillus rhamnosus.
Wang (Current Pharmaceutical Design 23.7 (2017): 1077-1097) reports Salvia miltiorrhiza is a natural herb (Fig. 1). Extracts from this herb are also products of nature. Miyazaki (USPN 5,332,803) reports wheat α-amylase inhibitor is naturally found in wheat (column 1 lines 54-55). Bifidobacterium animalis subsp. lactis and Lactobacillus rhamnosus are naturally occurring bacteria as reported by MedlinePlus (page 1 first para.) and Segers (Microbial cell factories 13 Suppl 1 (2014): S7, Introduction), respectively.
Claim 2 recites the composition further comprises an alfalfa extract. Alfalfa is natural plant and extracts from this plant are also products of nature.
Claim 3 recites the composition further comprises a momordica charantia extract, a fructus mume extract, a strawberry extract, a rhodiola rosea extract, a chrysanthemum extract, and a mulberry leaf extract.
Bortolotti (Frontiers in pharmacology 10 (2019): 486) reports Momordica charantia is a natural plant (Abstract). Extracts from this herb are also products of nature. Kim (Journal of medicinal food 19.2 (2016): 196-204) reports Fructus mume is a natural fruit (Abstract). Extracts from this herb are also products of nature. Strawberry, chrysanthemum and mulberry leaf are natural plants and their extracts are also products of nature. Li (Current pharmacology reports 3.6 (2017): 384-395) reports Rhodiola rosea is a natural plant (page 2 last para.). Extracts from this plant are also products of nature.
There is no change in any characteristic of the recited products compared to their naturally occurring counterparts and combining them into the recited composition does not change any of their natural characteristics individually or in combination. The claimed product lacks markedly different characteristics, and is a product of nature. This judicial exception is not integrated into a practical application because merely combining products of nature into a composition does not add a meaningful limitation. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because formulation of plant extracts and probiotics into compositions is well-understood, routine, and conventional activity in the field.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Yoon (US20200171115 A1, published 06/04/2020) in view of Miyazaki (US 5,332,803) and Kim (KR20230025725 A, published 02/23/2023)
Regarding claim 1, the term “NFR” is interpreted to mean Nuclear Respiratory Factor. Yoon teaches a composition comprising Salvia miltiorrhiza extract in an amount of 0.0001 to 50% by weight, preferably 0.1 to 25% by weight ([0092]). Yoon teaches the composition is used to treat obesity (Abstract). While the exact concentration is not disclosed by Yoon, one of ordinary skill in the art would be motivated to modify the composition and optimize the concentration of the extract depending on the subject and on the dosage regimen.
Yoon does not teach a wheat α-amylase inhibitor in the composition.
However, Miyazaki teaches a composition comprising α-amylase inhibitor from wheat and teaches the composition is used to treat obesity (Abstract). Miyazaki teaches a composition comprising 1% of the α-amylase inhibitor (2g of powder in 200 ml tea) (Example 2, Table 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition taught by Yoon by adding wheat α-amylase inhibitor, as suggested by Miyazaki and to optimize the concentration of the inhibitor. MPEP §2144.06(I) states that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In the instant case, one of ordinary skill in the art would be motivated to do so in order to treat obesity. Since both Yoon and Miyazaki teach a desire to form a composition with a health benefit, there is a reasonable expectation of success.
Yoon teaches S. miltiorrhiza extract can be added to Lactobacillus fermented milk but does not teach probiotic powder comprising Bifidobacterium animalis subsp. lactis with a weight proportion of 50% and Lactobacillus rhamnosus with a weight proportion of 50%.
However, Kim teaches a composition with Lactobacillus mixed powder comprising Lactobacillus rhamnosus and Bifidobacterium animalis lactis (Abstract). Kim teaches the powder comprises by weight 6% Lactobacillus rhamnosus and 5% Bifidobacterium animalis ssp. lactis (page 3 para. “Preparation of lactic acid bacteria mixture powder”). Kim teaches the composition comprises 2 to 7% by weight of lactic acid bacteria mixed powder (page 3 para. 4). Kim teaches the composition is for anti-obesity (Title).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the composition taught by Yoon by adding probiotic mixed powder comprising Lactobacillus rhamnosus and Bifidobacterium animalis ssp. lactis, as suggested by Kim, and to optimize the concentration of the probiotic powder and the concentration of the individual strains. One of ordinary skill in the art would be motivated to do so in order to form an effective composition with anti-obesity effect.
The limitation “NRF mitochondria activating ingredients, which has telomere extension, anti-aging, and cell rejuvenating effects” is a recitation of intended use. It does not add any compositional or structural limitations to the claimed composition and is not considered to contribute to the patentability of the claimed composition. See MPEP 2111.02.
Applicant discloses the Salvia miltiorrhiza extract contains NRF mitochondrial activating ingredients and can activate mitochondria (Specification [0011]). Since Yoon teaches the composition comprising S. miltiorrhiza extract, then the limitation of NRF mitochondria activation would be met when the teachings of Yoon are practiced.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Yoon, Miyazaki and Kim as applied to claim 1 above, and further in view of Raeeszadeh (Oxidative medicine and cellular longevity 2022.1 (2022): 2691577).
Regarding claim 2, Yoon does not teach the composition comprises alfalfa extract.
However, Raeeszadeh teaches alfalfa extract has anti-inflammatory effect (Abstract), and teaches a composition with 100 mg/kg or 500 mg/kg alfalfa extract (which equals to 0.01% or 0.05% alfalfa extract, respectively) (page 3 para” 2.9. Experimental Design”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the composition taught by Yoon by adding alfalfa extract as suggested by Raeeszadeh. One of ordinary skill in the art would be motivated to do so in order to form a health composition with anti-inflammatory effect. Since Yoon and Raeeszadeh teach a desire to form a composition with health benefits, there is a reasonable expectation of success.
While the exact concentration of alfalfa extract is not disclosed by Raeeszadeh, it is generally noted that differences in concentration do not support the patentability of subject matter encompassed by the prior art. Where 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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Yoon, Miyazaki and Kim as applied to claim 1 above, and further in view of Chen (US20210386812, published 12/16/2021) and Giampieri (Food & function 6.5 (2015): 1386-1398) as evidenced by Bortolotti (Frontiers in pharmacology 10 (2019): 486).
Regarding claim 3, Yoon does not teach the composition comprises a momordica charantia extract, a fructus mume extract, a strawberry extract, a rhodiola rosea extract, a chrysanthemum extract, and a mulberry leaf extract.
However, Chen teaches a composition comprising a rhodiola rosea extract (claim 125) and teaches composition can further comprise bitter melon extract, alfalfa extract, chrysanthemum extract, mulberry leaf extract, Fructus mume and Chinese Salvia ([0042], Table 1, Table 3, Table 5). Evidentiary reference Bortolotti reports Momordica charantia is known as bitter melon (Abstract). Chen teaches the concentration of each extract is 166.7 µg/ml and 333 µg/ml (i.e., 0.016% and 0.033%, respectively) ([0262]). Chen teaches these extracts have health benefits and are antioxidants (Example 2).
Giampieri teaches strawberry extract is used as ingredient in functional foods and dietary supplements, combined with other colorful fruits, vegetables, and herbal extracts, and are good source of several vitamins and nutrients (page 1386 right column para. 1-2). Giampieri teaches strawberry phenolics are antioxidants (Abstract). Giampieri teaches administering 2% of strawberry extract (Table 1 4th row).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the composition taught by Yoon by adding a Momordica charantia extract, a Fructus mume extract, a Rhodiola rosea extract, a chrysanthemum extract, a mulberry leaf extract and a strawberry extract as suggested by Chen and Giampieri. One of ordinary skill in the art would be motivated to do so in order to make a health composition with antioxidants. Since Yoon, Chen and Giampieri teach a desire to form a composition with health benefits, there is a reasonable expectation of success.
While the exact concentration is not disclosed by Chen and Giampieri, it is generally noted that differences in concentration do not support the patentability of subject matter encompassed by the prior art. Where 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.
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 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of copending Application No. 18/624174 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the copending claims.
Regarding instant claim 1, copending claim 1 recites an anti-aging composition, comprising: 5-20 wt% of an extract of Salvia miltiorrhiza, 25-40 wt% of an α-amylase inhibitor and 50-60 wt% of probiotics, wherein the probiotics comprise a Bifidobacterium animalis subsp. Lactis and a Lacticaseibacillus rhamnosus.
Regarding instant claims 2-3, copending claim 4 recites the composition further comprising 1-10 wt% of an extract selected from at least one of an extract of Medicago sativa (i.e., alfalfa), an extract of Momordica charantia, an extract of Prunus mume, an extract of Fragaria amamassa (i.e., strawberry), an extract of Rhodiola rosea, an extract of Chrysanthemum morifolium and an extract of leaf from Morus plant (i.e., mulberry).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/MARY A CRUM/Examiner, Art Unit 1657