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 .
Priority
The present application claims priority to Taiwanese application TW112143308 (filed on 11/09/2023).
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 1-8 are currently pending and have been examined on their merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/20/2025 is in compliance with the provisions of 37 C.F.R. 1.97. All references cited in this IDS have been fully considered.
Drawings
The drawings are objected to because Figs. 1-3 lack labels on the Y-axis. It is not clear, based upon the specification or the figures, what the unit displayed on each of the axes is.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action.
The objection to the drawings will not be held in abeyance.
Claim Interpretation
Claim 1 recites accession numbers. Accession numbers are arbitrary identifiers assigned by a depository. Accordingly, these numbers do not impart any meaningful structural limitations on the claimed Lactobacillus strain. For example, a Lactobacillus paracasei NB23 strain deposited under BCRC911201 or DSM 35133 is structurally indistinguishable from the same strain deposited under a different accession number or not deposited at all. Accordingly, for the purpose of applying prior art, the claim and the claims which reference this strain have been examined for Lactobacillus paracasei NB23, irrespective of if the prior art describes the strain by the same accession numbers.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112:
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.
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.
Claims 1-8 are rejected under 35 U.S.C. 112(a), as failing to comply with the enablement (biological deposit) requirement.
The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification lacks complete deposit information for the deposit of Lactobacillus paracasei NB23, said strain being deposited:
At the Food Industry Research and Development Institute in Hsinchu City, Taiwan, on October 4, 2023, under accession number BCRC911201; and
At the Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH (DSMZ) on September 5th, 2024, under deposit number DSM 35133 (claim 1; Specification, [0007]).
Because it is not clear that the properties of these strains are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the best mode disclosed by the specification requires the use of this specific strain, a suitable deposit for patent purposes is required.
It is noted that the deposited strain was accepted by the Food Industry Research and Development Institute on October 17, 2023 (1-page “Miscellaneous Incoming Letter” dated 10/22/2024, page 1) and by DSMZ on September 9th, 2024 (4-page “Miscellaneous Incoming Letter” dated 10/22/2024, page 3). Based upon the deposit receipt for DSMZ, the deposit was made under the provisions of the Budapest Treaty.
Because the deposit has been made under the provisions of the Budapest Treaty, the deposit requirement may be fulfilled by filing an affidavit or declaration by applicants or assignees or a statement by an attorney of record who has authority and control over the conditions of the deposit over his or her signature and registration number averring that:
the deposit was made under the Budapest treaty and “all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent”.
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.
Because the DSMZ deposit was made after the effective filing date of the application for patent in the United States (11/09/2023), a verified statement is required from a person in a position to corroborate that the cell line described in the specification as filed is the same as that deposited in the depository. Corroboration may take the form of a showing of a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant's possession at the time the application was filed.
Applicant's attention is directed to In re Lundak, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR § 1.801-1.809 for further information concerning deposit practice.
Claims 1-8 are rejected under 35 U.S.C. 112(a), as failing to comply with the enablement requirement.
The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The factors considered when determining if there is sufficient evidence to support that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue” include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). MPEP § 2164.04
further states that although the analysis and conclusion of a lack of enablement are based on these factors and the evidence as a whole, it is not necessary to discuss each factor in the enablement rejection.
With respect to the nature of the invention, applicant’s methods are directed to methods for treating or preventing sarcopenia, metabolic syndrome, and/or a cardiovascular disease.
Claim 3 limits the method to comprise a step of administering an effective amount of:
The Lactobacillus paracasei NB23 strain of claim 1;
a metabolite thereof;
or a composition containing the Lactobacillus paracasei NB23 strain or the metabolite
to an individual in order to “prevent the individual from having muscle loss or insufficient muscle mass or improve the individual’s muscle loss or insufficient muscle mass.
Claim 4 limits the method of claim 3 to require that the administered composition “is used to inhibit expression of the individual’s nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB) and forkhead box protein-O (Fox-O).
Claim 5 limits the method of claim 3 to require that the administered composition “is used to increase the individual’s muscle mass”.
Claim 6 limits the method of claim 3 to require that the administered composition “is used to activate a signaling pathway of the individual’s insulin-like growth factor 1 (IGF-1)”.
Claim 7 limits the method of claim 3 to require that the “metabolic syndrome” is associated with an imbalance of blood pressure, blood glucose, low-density lipoprotein cholesterol, and triglycerides.
Claim 8 limits the method of claim 3 to require that the cardiovascular disease is caused by vascular sclerosis.
With respect to the breadth of the claims, applicant has not provided any special definitions for the terms “treating” or “preventing”. Accordingly, these terms have been interpreted under their broadest reasonable interpretation and in line with their conventional meaning. That is, the “treating” aspect is considered to refer to therapeutic alleviation of one or all of the listed disorders and the “prevention” aspect is considered to require a complete reduction in the probability of developing one or all of the listed disorders.
With respect to the state of the prior art, the closest prior art is Kim (US 2022/0249581 A1) which teaches compositions for preventing or treating a metabolic disease or muscle disease by administering vesicles derived from Lactobacillus (abstract). Kim teaches the use of Lactobacillus paracasei among others in the Lactobacillus genus ([0014]). Among the conditions taught by Kim are metabolic syndrome ([0016]), sarcopenia ([0028]), and arteriosclerosis ([0003]; considered to be a type of “vascular sclerosis”). Kim does not teach the use of Lactobacillus paracasei NB23 nor “metabolites” for the treatment of these conditions because it is silent as to the specific strain and extracellular vesicles are not considered to be “metabolites”.
Similarly, Lin et al. (US 2020/0306324 A1) teaches compositions comprising Lactobacillus paracasei or a metabolite thereof for reducing body fat or increasing muscle mass ([0023]). Specifically, Lin teaches compositions derived from Lactobacillus paracasei TCI 058 for this purpose (abstract).
The prior art does not teach the strain Lactobacillus paracasei NB23 nor does it teach the use of metabolites from Lactobacillus paracasei NB23 for treating or preventing sarcopenia, metabolic syndrome, and/or a cardiovascular disease.
With respect to the amount of guidance provided by the inventors and the existence of working examples, applicant has provided the following examples.
First, applicant added NB23 at 8x, 16x, 50x, and 200x dilution to C2C12 muscle cells. Applicant then analyzed the absorbance of each of the samples to determine the 2,2-diphenyl-1-picrylhydrazyl (DPPH) free radicals. Applicant reports that Lactobacillus paracasei NB23 removed 69.81, 53.14, 32.81, and 20.46% of DPPH free radicals (Table 2).
Second, applicant tested NB23 at 16x, 50x, and 200x and cultured with C2C12 muscle cells to determine cell survival. Applicant reports that 16x Lactobacillus paracasei NB23 resulted in 145.04, 93.92, and 61.67% survival at 24, 48, and 72 hours. At 50x, Lactobacillus paracasei NB23 resulted in 89.79, 96.09, and 79.86% survival at the same intervals and 200x resulted in 84.1, 96.75, and 90.79% survival at the same intervals.
Third, applicant tested NB23 with C2C12 muscle cells and assessed the expression of PI3K, Akt, and mTOR proteins. The protein content of the muscle cells cultured with NB23 was 11.41 after 12 hours and 13.86 after 24 hours.
In light of these findings, applicant concludes that Lactobacillus paracasei NB23 can remove free radicals in muscle cells, maintain the proliferation and survival rate of muscle cells, encourage the proliferation and hypertrophy of muscle cells by enhancing the expression of PI3K and Akt proteins, and promote the synthesis and increase of muscles by increasing the expression of mTOR ([0042]).
Fourth, applicant provided NB23 to human subjects in the amount of 50 billion CFU twice daily ([0046]). After 12 weeks, applicant assessed the muscle strength and function (Tables 7-10). Applicant concludes that skeletal muscle in the torso and the number of times of stand-to-sit per minute of NB23 was significantly higher in the test group than the placebo group.
Applicant asserts that Table 7 demonstrates that NB23 caused significantly greater improvements in diastolic pressure, body fat percentage, skeletal muscle percentage, and number of times of stand-to-sit per minute.
Applicant asserts that Table 8 demonstrates that female subjects showed an increase in muscle and a significant decrease in body fat percentage than the placebo group. Additionally, male subjects showed a greater decrease in diastolic pressure than female counterparts.
Applicant asserts that Table 9 demonstrates that subjects aged 40-60 showed a significantly greater increase in skeletal muscle than subjects aged 20-40.
Applicant asserts that Table 10 demonstrates that subjects with BMI < 24 kg/m2 showed a significant increase in muscle, sit-to-stand, diastolic pressure, and body fat.
Fifth, applicant tested the blood chemistry of patients at week 0 and 12. Applicant asserts that the cardiovascular sclerosis indication factors of the subject in the NB23 group were significantly lower in week 12 than in week 0 and subjects had a significantly greater increase in vitamin D in blood than the placebo group.
Sixth, applicant tested the muscle protein synthesis/degradation regulation factors and cell differentiation and maturation factors. Applicant concludes that the subjects taking NB23 had a significantly lower serum insulin, a significant decrease in TNFα and IL-6, and a significant increase in expression of mTOR and MyoD.
The examiner has reviewed each of the above assertions and although there are differences between the NB23 group and the placebo group, there is no indication as to whether these differences are statistically significant. And to the extent that applicant characterized a result as “significant”, many results are clearly not statistically significant because of the overlapping ranges between the two groups (as demonstrated by the mean + standard deviation). For example, applicant asserts that Table 7 demonstrates a significant improvement in diastolic pressure. NB23 had a -3.96 mmHg change with a standard deviation of 5.12 compared to the placebo group which had a 0.44 mmHg change with a standard deviation of 5.37. Thus, there is at least some level of variability in the success of the method depending on the patient.
With respect to the level of one of ordinary skill, a person having ordinary skill in the art is a person having an advanced understanding of microbiology or biomedical science.
With respect to the amount of experimentation and the level of predictability, as discussed above, the prior art does not teach or suggest the use of Lactobacillus paracasei NB23 for the purpose of “treating or preventing sarcopenia, metabolic syndrome, and or a cardiovascular disease”. Accordingly, a person having ordinary skill in the art could look only to applicant’s disclosure to enable the invention. Although applicant may possess evidence that certain endpoints may be achieved by administering the strain per se, the scope of what has been claimed is much broader than what has been demonstrated by the specification because:
in its broadest form, applicant has not demonstrated treatment of sarcopenia, metabolic syndrome, and/or a cardiovascular disease;
in its broadest form, applicant has not demonstrated prevention of sarcopenia, metabolic syndrome, and/or a cardiovascular disease;
applicant has only tested a single regimen involving a single amount of Lactobacillus paracasei NB23 per se (5 x 1010 CFU twice daily for 12 weeks); and
applicant has not tested the administration of “a metabolite thereof”, as encompassed in the scope of the claim.
Conclusion
In light of each of the above factors, the claims fully lack enablement because even in their most narrow scope (i.e., administration of 5 x 1010 CFU twice daily for 12 weeks), applicant has not demonstrated that sarcopenia, metabolic syndrome, and cardiovascular disease can be treated or prevented and a person having ordinary skill in the art would therefore need to perform an undue amount of experimentation in order to determine which, if any, treatment regimens achieve “treatment” or “prevention” of these conditions.
Claims 2-8 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement.
The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention.
In order to satisfy the written description requirement for applicant’s claim to compositions comprising “a metabolite” of Lactobacillus paracasei NB23 and methods of administering the same, applicant must disclose sufficiently detailed, relevant identifying characteristics. These characteristics include the complete or partial structure, other physical or chemical properties, or functional characteristics when coupled with a known or disclosed correlation between function and structure. Additionally, applicant may meet this requirement by sufficiently describing a representative number of species within the claimed genus.
Applicant defines “metabolite” to mean a byproduct of the culturing process of the Lactobacillus paracasei NB23 strain, wherein the byproduct may exist in the culture medium ([0025]). Applicant has not identified or disclosed the structure of any “metabolite” (let alone a representative number of “metabolites” for the generic claim) nor has any metabolite been used in methods of treating or preventing sarcopenia, metabolic syndrome, and/or a cardiovascular disease.
Accordingly, a person having ordinary skill in the art would not recognize that applicant had possession of a composition comprising a metabolite thereof or methods of using a metabolite to treat or prevent sarcopenia, metabolic syndrome, and/or a cardiovascular disease at the time the application was filed.
Claims 2-8 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 2 recites “an effective amount of the Lactobacillus paracasei NB23 strain of claim 1 or a metabolite thereof”. It is not clear what constitutes an “effective amount” of the composition. It is noted that applicant defines the term “effective amount” to mean “an amount in which a probiotic or a metabolite thereof is administered and that can alleviate or improve one or more symptoms of the disease to be treated, reduce the discomfort of one or more symptoms of the disease, or slow down the progression of the disease” ([0023]). Nonetheless, this special definition is not sufficient to clarify the meaning of the term “effective amount” in the context of this claim because this claim does not specify any particular effect and the specification implies a multitude of “effects”. The phrase "an effective amount" has been held to be indefinite when the claim fails to state the function which is to be achieved and more than one effect can be implied from the specification or the relevant art (MPEP § 2713.05(c)).
Claim 3 recites “an effective amount of the Lactobacillus paracasei NB23 strain of claim 1, a metabolite thereof, or a composition containing the Lactobacillus paracasei NB23 strain or the metabolite”. The common phrase "an effective amount" may or may not be indefinite. The proper test is whether or not one skilled in the art could determine specific values for the amount based on the disclosure (MPEP § 2173.05(c)). As discussed above in the Written Description rejection, applicant has not provided any compositions or methods of using “a metabolite” of Lactobacillus paracasei NB23. Accordingly, a person having ordinary skill in the art could not determine what is meant by “an effective amount” in the context of “a metabolite” in this claim because there is no disclosure of an amount of a metabolite.
Claims 4-8 are rejected because they inherit the indefinite language and do not further clarify the meaning.
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 1-2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature and natural phenomenon without significantly more.
The instant claims recites laws of nature and natural phenomena. These judicial exceptions (JEs) are not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception as explained below:
Subject Matter Eligibility Guidance
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP § 2106:
Step (1): Is the claim directed to a process, machine, manufacture, or composition of matter?
Step (2A): Is the claim directed to a law of nature, natural phenomenon (product of nature), or an abstract idea?
Prong 1 – Does the claim recite a law of nature, natural phenomenon, or an abstract idea?
Product of Nature Definition
When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979.
The Markedly Different Characteristics Analysis
The first step in the analysis is to select the appropriate counterpart to the nature-based product. When the nature-based product is derived from a naturally occurring thing, then the naturally occurring thing is the counterpart. See MPEP § 2106.04(c)(II)(A).
The second step in the analysis is to identify appropriate characteristics to compare. Appropriate characteristics must be possessed by the claimed product, because it is the claim that must define the invention to be patented. Cf. Roslin, 750 F.3d at 1338, 110 USPQ2d at 1673. See MPEP § 2106.04(c)(II)(B).
The final step in the markedly different characteristics analysis is to compare the characteristics of the claimed nature-based product to its naturally occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed product are markedly different. See MPEP § 2106.04(c)(II)(C).
Prong 2 – If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application?
Limitations that are indicative of integration into a practical application include:
Improvements to the functioning of a computer, or to any other technology or technical field. See MPEP § 2106.05(a);
Applying the judicial exception with, or by use of, a particular machine. See MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing. See MPEP § 2106.05(c);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. See MPEP § 2106.05(d);
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. See MPEP § 2106.05(e).
Step (2B). If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly different than the judicial exception such that they provide an inventive concept? This step includes evaluation of the same considerations under Step (2A), Prong 2, as well as two additional considerations:
Adding a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; and
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Analysis
Step (1)(direction to a process, machine, manufacture, or composition of matter):
Claims 1-2 are directed to a composition of matter, which is a statutory category.
Therefore, the answer to this step for claims 1-2 is yes.
Step (2A) Prong 1 (recitation of a law of nature, natural phenomenon, or an abstract idea):
Claim 1 is directed to the bacterial strain Lactobacillus paracasei NB23 per se.
Although the specification is silent as to the origin of this bacterial strain, Lee et al. (Nutrients, 2025, Vol. 17(15), pages 1-18) provides evidence that this strain is a product of nature by teaching that “Lacticaseibacillus paracasei NB23 was isolated from a plant-based fermented product” (p. 3, Section 2.1).
Claim 2 is directed to compositions comprising said strain or a metabolite thereof. As discussed above, the strain itself is naturally occurring and therefore the metabolites produced by said strain are also necessarily naturally occurring.
Because claims 1-2 recite natural products, the next relevant question is whether the recited strain is markedly different from its natural counterpart. As discussed above, the strain exists in nature and therefore compositions comprising the strain per se are not markedly different from the strain in nature. That is to say, forming a composition with said strain does not markedly change the structure, properties, or functions of the strain. And although claim 2 requires “an effective amount” of the product of nature, there is no evidence that formulating “an effective amount” causes the product of nature to be markedly different because the product of nature merely performs the same function that it does in nature
Therefore, the answer to this prong for claims 1-2 is yes.
Step (2A) Prong 2 (recitation of additional elements that integrate the JE into a practical application):
Claim 1 recites arbitrary accession numbers, accordingly these limitations to not integrate the judicial exception such as by effecting a transformation of the judicial exception into a different state or thing.
Claim 2 requires “an effective amount” of the judicial exception. Merely formulating more of the judicial exception (such as by concentrating the judicial exception) does not integrate the JE into a practical application because it is not applied in any way nor is it changed into a different state or thing.
Therefore, the answer to this prong for claims 1-2 is no.
Step (2B)(recitation of additional elements that amount to significantly different than the JE such that they provide an inventive concept):
Lin et al. (US 2020/0306324 A1) provides evidence that Lactobacillus paracasei strains and metabolites thereof are not inventive by teaching that “Lactobacillus paracasei is a Gram-positive bacterium and is a facultative heterofermentative lactic acid bacterium, which is commonly used in the fermentation of dairy products” ([0022]). Additionally, Lin et al. provides methods of reducing body fat by administering a composition comprising an effective amount of Lactobacillus paracasei or a metabolite thereof to a subject in need thereof (abstract).
Accordingly, claims 1-2 do not recite additional elements which provide an inventive concept because they recite natural products per se and Lin demonstrates that compositions comprising Lactobacillus paracasei are “common” (i.e., routine and well-understood) in the art.
Therefore, the answer to step (2B) is no.
Conclusion
Claims 1-2 are directed to a judicial exception and do not qualify as eligible subject matter under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102
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.
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.
Claim 2 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Lin et al. (US 2020/0306324 A1).
Claim 2 recites a composition comprising an effective amount of the Lactobacillus paracasei NB23 strain of claim 1 or a metabolite thereof.
As discussed above, applicant defines “metabolite” to mean a byproduct of the culturing process of the Lactobacillus paracasei NB23 strain, wherein the byproduct may exist in the culture medium ([0025]). Thus, the scope of this claim encompasses any composition comprising an effective amount of any “byproduct” of Lactobacillus paracasei NB23.
Lin et al. provides methods of reducing body fat by administering a composition comprising an effective amount of Lactobacillus paracasei or a metabolite thereof to a subject in need thereof (abstract). Specifically, Lin teaches embodiments wherein Lactobacillus paracasei or the metabolite thereof increases whole body muscle or trunk muscle mass ([0010]). Lin defines “metabolite thereof” similar to applicant by stating that it is “a substance which is secreted into the bacterial culture solution after being metabolized by the bacteria, comprising the culture medium for culturing the bacterium” ([0026]).
Although Lin does not teach or suggest compositions comprising Lactobacillus paracasei NB23, it does teach compositions comprising an effective amount of a metabolite of Lactobacillus paracasei. The prior art reference is open to any metabolite of Lactobacillus paracasei. Accordingly, although the “metabolite” of the instant claim is limited only to metabolites from the novel strain, there is a reasonable expectation that at least one of Lin’s “metabolites” are “a metabolite” from Lactobacillus paracasei NB23. This position is supported by Lin’s disclosure that the genome of Lactobacillus paracasei “is slightly different between the different strains isolated”.
Accordingly, because the instant claim is open to compositions comprising an effective amount of any metabolite of Lactobacillus paracasei NB23 and because Lin discloses compositions comprising an effective amount of a metabolite of a generic Lactobacillus paracasei, the prior art anticipates the claim.
Conclusion
No claim is allowed.
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/GRANT C CURRENS/Examiner, Art Unit 1651
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