DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-22 are pending and examined on the merits.
Claim Objections
Claim 7 is objected to because of the following informalities:
Claim 7 is objected to because “the modulating blood lipids comprise” is grammatically incorrect since the act of modulating blood lipids is a single action. The recitation “comprise” should be substituted with “comprises.”
Appropriate correction is required.
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 2-12 and 14 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 recites the limitation "the culture as claimed in claim 1" in line 1. There is insufficient antecedent basis for this limitation in the claim. Parent claim 1 does not recite a culture, and instead recites a novel Bifidobacterium breve. Since claim 2 is indefinite, then its dependent claims, claims 9-12, are rendered indefinite. Thus, claims 2 and 9-12 are rejected under 35 U.S.C. 112(b).
Claim 2 recites “Use of the culture as claimed in claim 1” and claims 3-6 and 8 recite “Use of the novel Bifidobacterium breve as claimed in claim 1 or a culture thereof” without any step. Therefore, claims 2-6 and 8 and their dependent claims, claims 7 and 9-12, are indefinite because they are “use” claims that attempt to claim a process without setting forth any steps involved in the process. MPEP 2173.05(q) states, “Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.” Thus, claims 2-12 are rejected under 35 U.S.C. 112(b).
Claim 14 is rendered indefinite by the recitation “1-6:1-12.” It is unclear whether it is setting forth a weight ratio range. It is unclear whether the weight ratio is 1-6 parts the novel B. breve or the culture thereof to 1-12 parts the prebiotic.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains 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 organism, Bifidobacterium breve deposited under deposit number BCRC 911145, is recited in the claims, and thus is essential to the claimed invention. Since the microorganism is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the microorganism is not so obtainable or available, the requirements of 35 U.S.C. §112 may be satisfied by a deposit of the biological material.
The specification does not disclose a repeatable process to obtain the microorganism, and it is not apparent if the biological material is readily available to the public. It noted that the deposit information for the strain is on page 16, first paragraph and page 105, line 13 through page 106, line 6 of the specification, but there is no indication in the specification as to public availability of the strain.
If the deposit is made under the Budapest Treaty, then an affidavit or declaration by applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that the specific strain will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R. §1.807); and
(e) the deposit will be replaced if it should ever become inviable.
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 2-12 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims recite a use but fail to recite steps. Therefore, the claims are not directed to a process. As indicated in MPEP 2173.05(q), “‘use’ claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101.” Claims 2-12 do not fall within at least one of the four categories of patent eligible subject matter because the claims are “use” claims that do not purport to claim a process, machine, manufacture, or composition of matter.
Claims 1 and 13-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation. Claims 1 and 13-22 are directed to a statutory category, i.e. a composition of matter (Step 1: YES).
Claim 1: Claim 1 recites a novel Bifidobacterium breve deposited under BCRC 911145. The strain was isolated from the human intestine (page 35, lines 3-5 and page 36, line 6 through page 37, line 8). Since the strain was obtained from a naturally occurring source, then the strain is naturally occurring. Therefore, claim 1 recites a ‘product of nature’ exception (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application because no ‘additional element’ other than the product of nature is recited in the claims. Thus, claim 1 does not recite any ‘additional element’ other than the judicial exception that integrates the judicial exception into a practical application (Step 2A, Prong Two: NO). As such, claim 1 is directed to a judicial exception (Step 2A: YES).
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because claim 1 does not recite any ‘additional element’ other than the judicial exception (Step 2B: NO). Accordingly, claim 1 is not eligible subject matter under 35 U.S.C. 101.
Claim 13: Claim 13 recites a probiotic composition comprising the strain of claim 1 or a culture thereof, and a prebiotic. As explained above with respect to claim 1, the claimed B. breve strain is a naturally occurring product. The culture of the B. breve strain (the BCRC 911145 strain) is also a naturally occurring product since the B. breve strain necessarily is in culture in its natural environment of the human intestine. Additionally, naturally occurring prebiotics are known in the art. This is evidenced by Al-Sheraji (Journal of Functional Foods. 2013. 5(4): 1542-1553) which discloses naturally occurring prebiotics such as galactooligosaccharides (GOS), inulin, and oligofructose (page 1544, left column, second paragraph; page 1549, right column first paragraph). Therefore, claim 13 recites a nature-based composition that is a combination of two naturally occurring products (the B. breve strain or a culture thereof, the prebiotic).
Under Step 2A, Prong One of the analysis, the nature-based composition of claim 13 is compared to its naturally occurring counterparts to identify markedly different characteristics based on structure, function, and/or other properties. Because the two products of nature (the B. breve strain or culture thereof, the prebiotic) do not occur in nature together, then each product is considered an ‘additional element’ to the other in the determination of markedly different characteristic(s) being conferred on each product. According to Al-Sheraji, special strains of bifidobacteria grow well on the prebiotic oligofructose (page 1544, right column, second paragraph). Also, the majority of oligosaccharides, which are one form of prebiotic, have been confirmed to enhance bifidobacteria numbers in the colon (page 1547, paragraph bridging left and right columns). Al-Sheraji further points out that several authors have recommended that the ingestion of 10 g/day of the prebiotic galactooligosaccharides is adequate to cause a bifidogenic effect (page 1547, right column, first paragraph). Therefore, it is evident that the effect of prebiotics on bifidobacterium depends on the particular prebiotic and their amount. Claim 13 does not limit the prebiotic, nor does it recite the concentration of the prebiotic, so the prebiotic does not necessarily promote the growth of the claimed B. breve strain. Even if the growth were promoted of bifidobacterium by the prebiotic, it only results in more of the bifidobacterium having the same properties as when the prebiotic is absent (thus, not markedly different). Additionally, the specification provides no evidence that combining the B. breve strain or culture thereof with the prebiotic would result in the B. breve strain or culture thereof, or the prebiotic having a markedly different property. Accordingly, claim 13 recites ‘product of nature’ exceptions (Step 2A, Prong One: YES).
The judicial exceptions are not integrated into a practical application. The recitation of “A probiotic composition” in claim 13 is not an ‘additional element’ to the products of nature because the B. breve strain is directed to a probiotic, thus resulting in the composition being a “probiotic composition.” Because the two products of nature (the B. breve strain or culture thereof; the prebiotic) do not occur together in nature, then each product of nature recited in claim 13 is considered an ‘additional element’ to the other product of nature. The combination of the two products of nature (B. breve strain or culture thereof; a prebiotic) does not set forth a practical application of each product of nature. Therefore, the additional element recited in claim 13 does not integrate the products of nature into a practical application (Step 2A, Prong Two: NO). As such, claim 13 is directed to judicial exceptions (Step 2A: YES).
Claim 13 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed in the preceding paragraph, each of the products of nature recited in claim 13 is directed to an ‘additional element’ to the other product of nature. Prior to Applicant’s invention and at the time of the filing of the application, the combination of a probiotic such as bifidobacterium and a prebiotic was well-understood, routine, and conventional activity in the field of probiotics. This is evidenced by Al-Sheraji, a review article, which discloses mixtures of probiotics and prebiotics that are often used in food products (page 1543, right column, last paragraph). Therefore, the combination of the claimed B. breve strain or culture thereof with a prebiotic is well-understood, routine, and conventional activity, signifying that the combination is not significantly more than the judicial exceptions (Step 2B: NO). Accordingly, claim 13 is not eligible subject matter under 35 U.S.C. 101.
Claim 14: Claim 14 further limits claim 13 by reciting the weight ratio of the two products of nature (the B. breve strain or culture thereof; the prebiotic). Under Step 2A, Prong One of the analysis, the claimed weight ratio would not appear to confer any markedly different characteristic on each product of nature because the specification provides no evidence that combining the B. breve strain or culture thereof with the prebiotic at the claimed weight ratio would result in the B. breve strain or culture thereof, or the prebiotic having a markedly different property. Accordingly, claim 14 recites ‘product of nature’ exceptions (Step 2A, Prong One: YES).
The judicial exceptions are not integrated into a practical application. The claimed weight ratio is another ‘additional element’ other than the products of nature, along with the ‘additional element’ discussed above with respect to claim 13. The weight ratio does not set forth a practical application of each product of nature. Therefore, the additional elements recited in claim 14 do not integrate the products of nature into a practical application (Step 2A, Prong Two: NO). As such, claim 14 is directed to judicial exceptions (Step 2A: YES).
Claim 14 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. In addition to the discussion above with respect to claim 13, the selection of a weight ratio of the two products of nature is well-understood, routine, and conventional activity in the field of probiotics. For instance, Al-Sheraji discloses that several authors have recommended that the ingestion of 10 g/day of the prebiotic galactooligosaccharides is adequate to cause a bifidogenic effect (page 1547, right column, first paragraph) - therefore, the selection of amounts of prebiotics and bifidobacterium is well-understood, routine, and conventional activity prior to Applicant’s invention and at the time of the filing of the application. Therefore, the additional elements recited in claim 14 (the combination of the two products of nature; the weight ratio of the two products of nature) do not significantly more than the judicial exceptions (Step 2B: NO). Accordingly, claim 14 is not eligible subject matter under 35 U.S.C. 101.
Claims 15-17: Regarding claim 15, the claimed B. breve as present in the human intestine is directed to a culture comprising the B. breve strain which has been cultured. Therefore, claim 15 is rejected under 35 U.S.C. 101 under the same basis as parent claim 13.
Regarding claims 16 and 17, as present in the human intestine, the claimed B. breve undergoes a life cycle that includes the B. breve being active or viable, and the B. breve dying. Therefore, a culture comprising active, viable, or dead bacterium of the claimed B. breve is a product of nature. Accordingly, claims 16 and 17 are rejected under 35 U.S.C. 101 under the same basis as parent claim 13.
Claim 18: The claimed B. breve as present in the human intestine is directed to a culture comprising the B. breve strain and the cultured supernatant of the B. breve strain since water is present in the human intestine. Therefore, claim 18 is rejected under 35 U.S.C. 101 under the same basis as parent claim 13.
Claim 19: Claim 19 further limits the prebiotic to a prebiotic comprising at least one of the specific recited extracts, including a banana extract, a tomato extract, an asparagus extract, a garlic extract, and an onion extract. The recited extracts are not products of nature, so the prebiotic of claim 19 is not a product of nature. Therefore, claim 19 is a nature-based composition comprising one naturally occurring product (the claimed B. breve strain or culture thereof).
The prebiotic recited in claim 19 is an ‘additional element’ other than the naturally occurring product (the B. breve strain or culture thereof). An extract does not appear to confer any markedly different characteristic on the claimed B. breve strain or culture thereof since the specification does not provide any evidence to support such a finding. Therefore, claim 19 recites a ‘product of nature’ exception (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application. As pointed out in the preceding paragraph, the prebiotic of claim 19 is an ‘additional element’ other than the product of nature. The recitation of the prebiotic does not provide a practical application of the product of nature. Therefore, claim 19 does not recite any ‘additional element’ other than the judicial exception that integrates the judicial exception into a practical application (Step 2A, Prong Two: NO). Accordingly, claim 19 is directed to a judicial exception (Step 2A: YES).
Claim 19 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to parent claim 13, prior to Applicant’s invention and at the time of the filing of the application, the combination of a probiotic and a prebiotic was well-understood, routine, and conventional activity in the field of probiotics, as evidenced by Al-Sheraji. Moreover, according to Shie-Lih (International Journal of Biomass and Renewables. 2020. 9(2): 14-21), at the time of its publication, 2020, most of the potential prebiotics were extracted from plant materials such as onion, etc. (page 15, left column, first paragraph), with direct extraction recognized for obtaining prebiotics (page 15, left column, second paragraph). Additionally, Shie-Lih teaches that most naturally occurring prebiotics can be found in some fruit and vegetables such as beans, asparagus, onion, raw garlic, and tomatoes which can be extracted through several techniques (abstract; page 15, left column, second paragraph). Since extracts such as a banana extract, a tomato extract, an asparagus extract, a garlic extract, and an onion extract (all embodiments of instant claim 19) were well-known as prebiotics as evidenced by Shie-Lih, then the combination of the claimed B. breve strain or culture thereof with a prebiotic that meets the limitation of claim 19 is well-understood, routine, and conventional activity, signifying that the combination of the prebiotic with the product of nature is not significantly more than the judicial exception (Step 2B: NO). Accordingly, claim 19 is not eligible subject matter under 35 U.S.C. 101.
Claims 20 and 21: The same analysis as applied to parent claim 19 applies to claims 20 and 21. With respect to the analysis under Step 2B, Al-Sheraji and Van Laere (J. Agric. Food Chem. 2000. 48: 1644-1652) provide evidence that a soybean extract and an apple extract are well known as prebiotics. In particular, Al-Sheraji is a review that cites Van Laere for disclosing extracting several prebiotics to determine their fermentation by different strains of bacteria, including Bifidobacterium (page 1544, right column, second paragraph). Van Laere, dated 2000, discloses using dehulled soy beans and apple as raw materials for the production of nondigestible oligosaccharides through extraction (abstract; page 1650, left column, second-to-last paragraph; page 1646, right column, second paragraph; page 1645, right column, last paragraph through page 1646, left column, second paragraph). Since a soybean extract and an apple extract were well-known as prebiotics as evidenced by the cited prior art, then the combination of the claimed B. breve strain or culture thereof with a prebiotic comprising soybean extract (as in claim 20) or a prebiotic comprising a soybean extract and apple extract (as in claim 21) is well-understood, routine, and conventional activity, signifying that the combination of the claimed prebiotic with the product of nature is not significantly more than the judicial exception (Step 2B: NO). Accordingly, claims 20 and 21 are not eligible subject matter under 35 U.S.C. 101.
Claim 22: Claim 22 further limits claim 13 by reciting that the probiotic composition is a food composition. Food such as fruit and vegetables is a naturally occurring product. Moreover, naturally occurring prebiotic can be found in various foods such as asparagus and tomatoes. This is evidenced by Al-Sheraji (page 1544, left column, second paragraph). Therefore, claim 22 recites a nature-based composition that is a combination of two naturally occurring products (the B. breve strain or a culture thereof, food that comprises a prebiotic).
Under Step 2A, Prong One of the analysis, the nature-based composition of claim 22 is compared to its naturally occurring counterparts to identify markedly different characteristics based on structure, function, and/or other properties. Because the two products of nature (the B. breve strain or culture thereof, food comprising a prebiotic) do not occur in nature together, then each product is considered an ‘additional element’ to the other in the determination of markedly different characteristic(s) being conferred on each product. According to Al-Sheraji, special strains of bifidobacteria grow well on the prebiotic oligofructose (page 1544, right column, second paragraph). Also, the majority of oligosaccharides, which are one form of prebiotic, have been confirmed to enhance bifidobacteria numbers in the colon (page 1547, paragraph bridging left and right columns). Al-Sheraji further points out that several authors have recommended that the ingestion of 10 g/day of the prebiotic galactooligosaccharides is adequate to cause a bifidogenic effect (page 1547, right column, first paragraph). Therefore, it is evident that the effect of prebiotics on bifidobacterium depends on the particular prebiotic and their concentration. Claim 22 does not limit the prebiotic, nor does it recite the concentration of the prebiotic, so the prebiotic does not necessarily promote the growth of the claimed B. breve strain. Even if the growth were promoted of bifidobacterium by a prebiotic, it only results in more of the bifidobacterium having the same properties as when the prebiotic is absent. Additionally, the specification provides no evidence that combining the B. breve strain or culture thereof with a prebiotic or food would result in the B. breve strain or culture thereof, the prebiotic, or food having a markedly different property. Accordingly, claim 22 recites ‘product of nature’ exceptions (Step 2A, Prong One: YES).
The judicial exceptions are not integrated into a practical application. Because the two products of nature (the B. breve strain or culture thereof; food comprising a prebiotic) do not occur together in nature, then each product of nature recited in claim 22 is considered an ‘additional element’ to the other product of nature. The combination of the two products of nature (B. breve strain or culture thereof; a food comprising a prebiotic) does not set forth a practical application of each product of nature. Therefore, the additional element recited in claim 22 does not integrate the products of nature into a practical application (Step 2A, Prong Two: NO). As such, claim 22 is directed to judicial exceptions (Step 2A: YES).
Claim 22 does not include additional elements that are sufficient to amount to significantly more than the judicial exceptions. As discussed in the preceding paragraph, each of the products of nature recited in claim 22 is directed to an ‘additional element’ to the other product of nature. Prior to Applicant’s invention and at the time of the filing of the application, the combination of a probiotic such as bifidobacterium and a prebiotic in food products was well-understood, routine, and conventional activity in the field of probiotics. This is evidenced by Al-Sheraji, a review article, which discloses mixtures of probiotics and prebiotics that are often used in food products (page 1543, right column, last paragraph). Therefore, the combination of the claimed B. breve strain or culture thereof with a food comprising prebiotic is well-understood, routine, and conventional activity, signifying that the combination is not significantly more than the judicial exceptions (Step 2B: NO). Accordingly, claim 22 is not eligible subject matter under 35 U.S.C. 101.
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kim (WO 2022/005035. Listed on IDS filed 2/20/25. English equivalent US 2023/0285474 cited below) discloses Bifidobacterium breve MCC 4401 and Bifidobacterium breve IDCC 4401 (abstract and claims 1-2 of Kim). The MCC 4401 strain has an excellent effect of reducing a cholesterol level in the body (abstract), and the dead cell ID-BBR4401 of the IDCC 4401 strain exhibits a cholesterol reduction effect at a stable and high level, particularly LDL-cholesterol (paragraphs [0060]-[0061]). Thus, the MCC 4401 and IDCC 4401 strains of Kim have common properties with the claimed BCRC 911145 strain, specifically being strains of the same species, and having the ability to reduce cholesterol and promote LDL-C metabolism (see instant claims 6 and 7). However, there is insufficient evidence to conclude that the MCC 4401 strain or the IDCC 4401 strain of Kim is directed to the claimed B. breve BCRC 91145 strain.
Kondo (US 2012/0171167) discloses Bifidobacterium breve MCC 1274 and/or Bifidobacterium breve ATCC 15700 as an anti-obesity agent (paragraph [0024] and claim 24 of Kondo). Thus, the MCC 1274 and ATCC 15700 strains of Kondo have common properties with the claimed BCRC 911145 strain, specifically being strains of the same species, and having the ability to reduce body weight (see instant claim 5). However, there is insufficient evidence to conclude that the MCC 1274 strain or the ATCC 15700 strain of Kondo is directed to the claimed B. breve BCRC 91145 strain.
Conclusion
No claims are allowed.
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Sef
/SUSAN E. FERNANDEZ/ Examiner, Art Unit 1651
