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 1-12 are pending and examined on the merits.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because the application does not contain a statement that the CRF is identical to the "Sequence Listing" part of the disclosure, as described above in item 1), as required by 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii).
Required response - Applicant must provide such statement.
Claim Objections
Claims 1-12 are objected to because of the following informalities:
Claims 1 and 4 are objected to because the recitation “subsp.” in line 2 should not be italicized, for consistency with the recitation “subsp.” in line 1. Also, the recitation “Aug.” in line 5 of each of claims 1 and 4 should be replaced with “August.” Since claim 1 is objected to, then its dependent claims, claims 2-3, are objected to.
Claim 4 is objected to because the recitation “dosage form of capsule, tablet, pill or powder” is not grammatically correct. The word “a” should be inserted before the recitation “capsule.”
Claim 5 is objected to because the recitation “subsp.” in line 4 should not be italicized, for consistency with the recitation “subsp.” in line 3. Also, the recitation “Aug.” in line 7 should be replaced with “August.” Since claim 5 is objected to, then its dependent claims, claims 6-12, are objected to.
Claim 9 is objected to because the recitation “16SrRNA” should be substituted with “16S rRNA” (i.e., a space should be inserted before “16S” and “rRNA”).
Claim 10 is objected to because the recitation “tuf” should be italicized.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-12 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 animalis subsp. lactis i797, 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 recited in claim 1 and page 3, lines 5-7 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 1-4 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. The claims are directed to a statutory category, i.e. a composition of matter (Step 1: YES).
Claim 1: Claim 1 recites a food or drink comprising Bifidobacterium animalis subsp. lactis i797, wherein the food is selected from cereals, fermented meat products, probiotics and dairy products, and wherein the drink is selected from beverages and fermented milk drinks. According to the specification, Bifidobacterium animalis subsp. lactis i797 was separated and screened from the feces of breast-fed infants or babies (page 8, lines 8-11). Therefore, the i797 strain is naturally occurring. Additionally, water, which is a naturally occurring product, is directed to a drink that is a beverage. Water is inherently present in the feces of breast-fed infants or babies which comprises the i797 strain. Therefore, the combination of the i797 strain and water (directed to a drink that is a beverage) naturally occurs so the combination is a product of nature. Accordingly, 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 claim. Therefore, 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).
The claim 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 2: Claim 2 recites a food or drink comprising the i797 strain, wherein the food is ‘probiotics’ (parent claim 1 embodiment), and wherein the probiotics are compound probiotics. As pointed out above, according to the specification, Bifidobacterium animalis subsp. lactis i797 was separated and screened from the feces of breast-fed infants or babies (page 8, lines 8-11). According to Zuo (Ann. Microbiol. 2016. 66: 1027-1037), infant feces is a good source of a collection of wild bifidobacteria (page 1027, right column). Also, as evidenced by Zuo, certain members of the genus Bifidobacterium are the most frequently used human probiotics because of their health-promoting properties (page 1027, right column). In fact, Zuo discloses a study in which 13 strains of Bifidobacterium were isolated from breast-fed infant feces and screened for desirable probiotic traits (page 1028, paragraph bridging left and right columns). Therefore, it follows that the feces of breast-fed infants or babies from which the claimed i797 strain was isolated comprises further probiotics, e.g. other Bifidobacterium. The combination of probiotics is directed to ‘compound probiotics.’ The bacteria as present in feces is a naturally occurring product. Therefore, the bacteria including the i797 strain in feces of breast-fed infants or babies is directed to a food (probiotics) comprising the i797 strain, wherein the probiotics are compound probiotics, is a naturally occurring product. Accordingly, claim 2 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 claim. Therefore, claim 2 does not recite any ‘additional element’ other than the judicial exception (the ‘food’ which is compound probiotics, comprising the i797 strain, which is a product of nature) that integrates the judicial exception into a practical application (Step 2A, Prong Two: NO). As such, claim 2 is directed to a judicial exception (Step 2A: YES).
Claim 2 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because claim 2 does not recite any ‘additional element’ other than the judicial exception (Step 2B: NO). Accordingly, claim 2 is not eligible subject matter under 35 U.S.C. 101.
Claim 3: Claim 3 further limits claim 2 by reciting that the food or drink comprises a probiotic selected from Lactobacillus paracasei N1115, Lactobacillus plantarum N3117, and Streptococcus thermophilus JMCC0003. Yao (Arch. Med. Sci. 2019. 15(5): 1336-1344. Online publication date July 12, 2019) discloses that Lactobacillus paracasei N1115 was produced from fermented dairy products (page 1337, left column, last paragraph). Since fermented dairy products are naturally occurring, then L. paracasei N1115 is a naturally occurring product. Therefore, claim 3 recites a nature-based composition that is a combination of products of nature (the i797 strain, compound probiotics including L. paracasei N1115 strain).
Under Step 2A, Prong One of the analysis, the nature-based composition of claim 3 is compared to its naturally occurring counterparts to identify markedly different characteristics based on structure, function, and/or other properties. Because the products of nature (the i797 strain, compound probiotics including L. paracasei N1115 strain) 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. Combining the i797 strain with other probiotics including the L. paracasei N1115 strain does not appear markedly change any characteristics of each product, because each product would appear to continue to have the same properties in the combination as it had alone, absent a showing of evidence by Applicant. Therefore, claim 3 recites ‘product of nature’ exceptions (Step 2A, Prong One: YES).
These judicial exceptions are not integrated into a practical application. The combination of the products of nature does not set forth a practical application of the composition of claim 3. As such, there is no integration of the products of nature into a practical application (Step 2A, Prong Two: NO), so the claim is directed to judicial exceptions (Step 2A: YES).
Claim 3 does not include additional elements that are sufficient to amount to significantly more than the judicial exceptions. Because the products of nature do not occur together in nature, then each product of nature in the composition of claim 3 is considered an ‘additional element’ to the other to determine whether their combination results in ‘significantly more’ than the products of nature. Prior to Applicant’s invention and at the time of the filing of the application, the combination of probiotics, including bifidobacteria and Lactobacillus strains, was well-understood, routine, and conventional. According to Pandey (J. Food Sci. Technol. 2015. 52(12): 7577-7587), probiotics are living microorganisms which when administered in adequate amounts confer a health benefit to the host (paragraph bridging pages 7577 and 7578). Pandey further discloses that probiotic products may contain a mixture of two or more strains (page 7578, left column, second full paragraph), and some of the popularly used probiotic microorganisms include bifidobacteria and Lactobacillus strains (page 7578, left column, first full paragraph).
Since the combination of bifidobacteria and Lactobacillus strains as probiotics was well known, as evidenced by Pandey, then the combination of bifidobacteria such as the claimed Bifidobacterium animalis subsp. lactis i797 and Lactobacillus such as the claimed L. paracasei N1115, is also well-understood, routine, and conventional activity. Accordingly, the combination of the products of nature of claim 3 is not significantly more than the judicial exceptions (Step 2B: NO). As such, claim 3 is not eligible subject matter under 35 U.S.C. 101.
Claim 4: Claim 4 recites a medicine comprising Bifidobacterium animalis subsp. lactis i797, wherein the medicine is in a dosage form of a capsule, tablet, pill, or powder. According to the specification, Bifidobacterium animalis subsp. lactis i797 was separated and screened from the feces of breast-fed infants or babies (page 8, lines 8-11). Therefore, the i797 strain is naturally occurring. Since the i797 strain is the active agent, then a composition comprising the i797 strain is directed to a ‘medicine’ as claimed.
The dosage form of a capsule, tablet, pill or powder is an ‘additional element’ other than the naturally occurring product (i797 strain). A capsule does not confer any markedly different characteristic on the i797 strain since it simply holds the i797 strain and thus does not modify any characteristic of the i797 strain itself. Therefore, claim 4 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 dosage form, which includes the embodiment of a capsule, is an ‘additional element’ other than the product of nature (the i797 strain). The recitation of the dosage form amounts to mere instructions to apply the product of nature, so the dosage form does not set forth integration of the product of nature into a practical application. Therefore, claim 4 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 4 is directed to a judicial exception (Step 2A: YES).
Claim 4 does not include additional elements that are sufficient to amount to significantly more. As pointed out above, the ‘additional element’ other than the product of nature is the dosage form, which includes the embodiment of a capsule. The recitation of a dosage form of a capsule is at best the equivalent of merely adding the words “apply it” to the product of nature (the i797 strain). The recitation of the dosage form amounts to mere instructions to apply the product of nature. Mere instructions do not amount to significantly more than a judicial exception. Therefore, the ‘additional element’ (dosage form of a capsule) does not amount to significantly more than the product of nature (the i797 strain) (Step 2B: NO). Accordingly, claim 4 is not eligible subject matter under 35 U.S.C. 101.
Notice Re: Prior Art Available Under Pre-AIA and AIA
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xun (CN 110959867 A. Machine Translation cited below).
Xun discloses, in the field of food, a humanized composite probiotics micro-capsule powder containing Bifidobacterium animalis subsp. lactis JMCC0025 (abstract on page 2, first paragraph; page 3, seventh paragraph). The JMCC0025 strain was deposited on August 20, 2019, under the preservation number No. 18403 (page 3, eighth paragraph). The preservation number is CGMCC No. 18403 because other preservation numbers for the same center are recited with “CGMCC” (page 3, second-to-last paragraph; page 4, first paragraph). Since the preservation number for the JMCC0025 strain is the preservation number of instant claim 1, then the JMCC0025 strain is the claimed Bifidobacterium animalis subsp. lactis i797. Moreover, the instant specification refers to the i797 strain as “JMCC0025” (Table 6 on page 19).
The composite probiotic bacteria microcapsule powder is disclosed as being edible by itself, or when mixed with infant formula milk (page 2, first paragraph; claim 10 of Xun on page 19). Additionally, the humanized composite probiotics micro-capsule powder comprises four kinds of probiotics which include the JMCC0025 strain (page 5, third paragraph). Therefore, the humanized composite probiotics micro-capsule powder of Xun is directed to a food comprising the claimed Bifidobacterium animalis subsp. lactis i797 (the JMCC0025 strain), wherein the food is probiotics. When the powder is mixed with infant formula milk, then the food is directed to a dairy product. As such, Xun anticipates instant claim 1.
Regarding instant claims 2 and 3, Xun discloses that the powder also comprises Lactobacillus paracasei N1115, Lactobacillus plantarum N3117, and Streptococcus thermophilus JMCC0003 (page 2, first paragraph; page 3, seventh paragraph). These bacteria are referred to as “compound probiotic” (e.g., page 8, FIG. 1 description; page 10, third paragraph). Also, those bacteria are the probiotics of instant claim 3. Therefore, Xun anticipates instant claims 2 and 3.
Regarding instant claim 4, the humanized composite probiotics micro-capsule powder is directed to a medicine (because of the presence of the JMCC0025 strain, i.e. i797 strain) that is in a dosage form of a powder. Therefore, instant claim 4 (powder) is anticipated.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5-12 are rejected under 35 U.S.C. 103 as being unpatentable over Xun in view of Xiao (Medicine. 2017. 96: 14(e5953). 7 pages).
As discussed above, Xun anticipates claims 1-4. Regarding claim 5, Xun discloses that their product (humanized composite probiotics micro-capsule powder) is edible and can promote the beneficial bacteria and enhances the intestinal flora of an infant (page 2, first paragraph). Also, the composite probiotic bacteria microcapsule powder is disclosed as being edible by itself, or when mixed with infant formula milk (page 2, first paragraph; claim 10 of Xun on page 19). In mixing the product of Xun (humanized composite probiotics micro-capsule powder) with infant formula milk for providing the product in edible form, then it would have been obvious to the person of ordinary skill in the art that Xun teaches administering to a subject (an infant) a drink (the infant formula milk) containing the i797 strain (as present in the humanized composite probiotics micro-capsule powder that is mixed with infant formula mix), thereby meeting limitations of instant claim 5. Moreover, since Xun’s product can promote the beneficial bacteria and enhances the intestinal flora of an infant (page 2, first paragraph), then its administration regulates an intestinal tract of a subject (an infant) and balances intestinal flora of a subject, thereby meeting limitations of instant claim 5.
Xun differs from instant claim 5 in that Xun does not expressly disclose evaluating, for the subject (the infant), one or more indexes selected from frequency of defecation, difficulty in defecation, hardness of feces, and shape of feces.
Xiao discloses providing for a randomized controlled trial to determine the effects of a combination of a novel 3-strain probiotics on digestibility and immunity in healthy infants (page 2, right column, second paragraph). The outcomes related to GI symptoms and well-being that were analyzed included weekly average number of stools, stool form, amount of stools, and color of stools (page 2, right column, second-to-last paragraph; page 6, left column, section 3.12). The stool form includes consistency (page 6, left column, section 3.12).
Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to evaluate weekly average number of stools (directed to ‘frequency of defecation’), stool form (consistency, directed to ‘hardness of feces’), and stool color (directed to ‘color of feces’ of instant claim 8) of the infant that is administered the humanized composite probiotics micro-capsule powder when performing the method of Xun. One of ordinary skill in the art would have been motivated to do this because it would have permitted the skilled artisan to assess the effects of the probiotics of Xun on digestibility and immunity in infants, thus allowing for determination that the method of Xun is beneficial to the infant. Therefore, instant claims 5, 7 (infant formula milk necessarily is administered orally), 8 (color of feces), 11, and 12 are anticipated.
Regarding instant claim 6, it would have been obvious to the person of ordinary skill in the art that the infant that is administered the infant formula milk is a human infant. Therefore, instant claim 6 is rendered obvious.
Regarding instant claims 9 and 10, Xun discloses the 16S rRNA sequence of the JMCC0025 strain and its tuf gene sequence on pages 6 and 7, which are identical to SEQ ID NO: 1 of instant claim 9 and SEQ ID NO: 2 of instant claim 10, respectively. Moreover, the JMCC0025 strain, i.e. the i797 strain, inherently has a 16S rRNA having the sequence of SEQ ID NO: 1 of instant claim 9 and its tuf gene inherently has the sequence of SEQ ID NO: 2 of instant claim 10. Therefore, Xun in view of Xiao renders obvious instant claims 9 and 10.
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Huo (CN 110150669. Machine Translation. Listed on IDS filed 1/21/25) and Chen (US 2020/0054691. Listed on IDS filed 1/21/25) are described in the Office Action mailed on December 5, 2024, in the parent application 17/784,654. See pages 11-15 of that Office Action for discussion of their teachings of strains of Bifidobacterium lactis which are directed to strains of Bifidobacterium animalis subsp. lactis. There is insufficient evidence to conclude that Bifidobacterium lactis BAL531 of Huo and Bifidobacterium lactis GKK2 of Chen are directed to the claimed Bifidobacterium animalis subsp. lactis i797 strain.
Conclusion
No claims are allowed.
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Sef
/SUSAN E. FERNANDEZ/Examiner, Art Unit 1651
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