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 1-15 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 - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
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 1-15 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 1 is rendered indefinite by the recitation “(accession number: NITE BP-03645).” It is unclear how the limitation in parentheses relates to the strain. It is unclear whether the term is necessary or optional. Since claim 1 is indefinite, then the claims incorporating claim 1, claims 2-15, are rendered indefinite. Therefore, claims 1-15 are rejected under 35 U.S.C. 112(b). This rejection can be overcome by substituting the recitation with “deposited under accession number NITE BP-03645.”
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 1-15 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 microorganism Lactobacillus sakei strain MG-LAB279 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 microorganism is on page 13, paragraph [0018] of the originally filed 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 1-15 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 Lactobacillus sakei strain MG-LAB279. Lactobacillus sakei are well known as naturally occurring microorganisms, thus the claimed MG-LAB279 strain appears to be a naturally occurring microorganism, absent showing by Applicant that it is not naturally occurring (e.g., genetically modified microorganism). 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 claim. 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 2: Claim 2 recites the strain according to claim 1 (which is a product of nature) and/or a bacterial cell component thereof. Since the MG-LAB279 strain appears to be a naturally occurring microorganism, then a bacterial cell component thereof is a naturally occurring product. Therefore, claim 2 recites a naturally occurring product (the MG-LAB279 strain or a bacterial cell component thereof) or two naturally occurring products (the MG-LAB279 strain and a bacterial cell component thereof). As such, 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(s) of nature (the MG-LAB279 strain and/or a bacterial cell component thereof) is recited in the claim. Thus, claim 2 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 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 1 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.
Claims 3 and 4: Like claim 2, claims 3 and 4 recite a composition comprising the strain according to claim 1 (which is a product of nature) and/or a bacterial cell component thereof (also a product of nature). See the discussion above regarding the rejection under 35 U.S.C. 101 of claim 2.
Under Step 2A, Prong One of the analysis, the claimed nature-based composition is compared to its naturally occurring counterpart in its natural state to identify markedly different characteristics based on structure, function, and/or other properties. Claim 3 recites that the composition is an immunostimulatory composition. Claim 4 further recites that the immunostimulatory composition does not induce inflammation. These limitations set forth properties inherent of the MG-LAB279 strain and a bacterial cell component thereof, particularly since the MG-LAB279 strain and/or a bacterial cell component thereof is recited as the active ingredient. Therefore, the limitations of an “immunostimulatory composition” and an immunostimulatory composition that “does not induce inflammation” do not set forth any markedly different characteristic of the claimed compositions as compared to their naturally occurring counterpart (a composition comprising the MG-LAB279 strain and/or a bacterial cell component thereof). Accordingly, claims 3 and 4 each recites a ‘product of nature’ exception (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application. The recitation of an “immunostimulatory composition” is the ‘additional element’ of claim 3 other than the judicial exception. The recitations of an “immunostimulatory composition” and “wherein the immunostimulatory composition does not induce inflammation” are the ‘additional elements’ of claim 4 other than the judicial exception. These limitations set forth an intended use that does not integrate the claimed product of nature into a practical application since claims 3 and 4 recite a product rather than a process. Accordingly, the additional element(s) recited in claims 3 and 4 do not integrate the product of nature into a practical application (Step 2A, Prong Two: NO). Therefore, claims 3 and 4 are directed to a judicial exception (Step 2A: YES).
Claims 3 and 4 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. See the preceding paragraph for the additional element(s) other than the judicial exceptions recited in claims 3 and 4. The additional elements set forth an intended use corresponding to properties inherently possessed by the MG-LAB279 strain and/or a bacterial cell component thereof, and thus do not amount to significantly more than the judicial exception. As such, the additional element(s) recited in claims 3 and 4 do not amount to significantly more than the claimed judicial exception (Step 2B: NO). Accordingly, claim 3 and 4 are not eligible subject matter under 35 U.S.C. 101.
Claims 5-11: Like claim 2, claims 5-11 recite a composition comprising the strain according to claim 1 (which is a product of nature) and/or a bacterial cell component thereof (also a product of nature). See the discussion above regarding the rejection under 35 U.S.C. 101 of claim 2.
Under Step 2A, Prong One of the analysis, the claimed nature-based composition is compared to its naturally occurring counterpart in its natural state to identify markedly different characteristics based on structure, function, and/or other properties. The preamble of each of claims 5-11 (e.g., A virus infection preventing or treating composition; An NK cell-activating composition) set forth properties inherent of the MG-LAB279 strain and a bacterial cell component thereof, particularly since the MG-LAB279 strain and/or a bacterial cell component thereof is recited as the active ingredient. Therefore, the limitations of the preamble of claims 5-11 do not set forth any markedly different characteristic of the claimed compositions as compared to their naturally occurring counterpart (a composition comprising the MG-LAB279 strain and/or a bacterial cell component thereof). Accordingly, claims 5-11 each recites a ‘product of nature’ exception (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application. The preamble of each of claims 5-11 are the ‘additional elements’ of the claims other than the judicial exception. These limitations set forth an intended use that does not integrate the claimed product of nature into a practical application since claims 5-11 recite a product rather than a process. Accordingly, the additional element recited in each of claims 5-11 does not integrate the product of nature into a practical application (Step 2A, Prong Two: NO). Therefore, claims 5-11 are directed to a judicial exception (Step 2A: YES).
Claims 5-11 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. See the preceding paragraph for the additional element other than the judicial exception recited in each of claims 5-11. The additional element of each of claims 5-11 sets forth an intended use corresponding to properties inherently possessed by the MG-LAB279 strain and/or a bacterial cell component thereof, and thus does not amount to significantly more than the judicial exception. As such, the additional element recited in each of claims 5-11 does not amount to significantly more than the claimed judicial exception (Step 2B: NO). Accordingly, claim 5-11 are not eligible subject matter under 35 U.S.C. 101.
Claim 12: Claim 12 recites a food or beverage comprising strain MG-LAB279 according to claim 1. As discussed above with respect to claim 1, the MG-LAB279 strain is a naturally occurring organism. Water is directed to a beverage and is directed to a naturally occurring product. Therefore, claim 12 is directed to a combination of two products of nature.
Under Step 2A, Prong One of the analysis, the nature-based composition of claim 12 is compared to its naturally occurring counterparts to identify markedly different characteristics based on structure, function, and/or properties. Because the products of nature (the MG-LAB279 strain; food or beverage such as water) 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 MG-LAB279 strain with a food or beverage (e.g., water, a product of nature) does not appear to markedly change any characteristic 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 12 recites ‘product of nature’ exceptions (Step 2A, Prong One: YES).
These judicial exceptions are not integrated into a practical application. The combination of the two products of nature (the MG-LAB279 strain; food or beverage such as water) does not set forth a practical application of the composition of claim 12. 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 12 does not include additional elements that are sufficient to amount to significantly more than the judicial exceptions. Because the two products of nature (the MG-LAB279 strain; food or beverage such as water) do not occur together in nature, then each product of nature in the composition of claim 12 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 water and Lactobacillus sakei was well-understood, routine, and conventional activity in culturing Lactobacillus sakei. This is evidenced by Lechiancole (Ann. Microbiol. 2002. 52: 257-274) which teaches optimization of media and fermentation conditions for the growth of Lactobacillus sakei (abstract), pointing out that media were prepared from stock solutions of the components and brought to volume with distilled water (page 261, first paragraph). Since the combination of the two claimed products of nature (the MG-LAB279 strain; water directed to a beverage) is well-understood, routine, and conventional activity, then the combination of the two claimed products of nature is not significantly more than the judicial exceptions (Step 2B: NO). As such, claim 12 is not eligible subject matter under 35 U.S.C. 101.
Claim 13: Claim 13 recites a pharmaceutical product comprising strain MG-LAB279 according to claim 1. As discussed above with respect to claim 1, the MG-LAB279 strain is a product of nature. The MG-LAB279 strain itself is directed to a pharmaceutical product given its inherent health benefits (e.g. immunostimulatory, etc.). Therefore, claim 13 recites a ‘product of nature’ exception (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application. The recitation of a pharmaceutical product does not set forth a practical application of the product of nature. Thus, claim 13 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 13 is directed to a judicial exception (Step 2A: YES).
Claim 13 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because claim 13 sets forth a property inherent to the product of nature (a pharmaceutical product) (Step 2B: NO). Accordingly, claim 13 is not eligible subject matter under 35 U.S.C. 101.
Claim 14: The claim recites a food or beverage comprising the composition according to claim 2. As discussed above, claim 2 recites a naturally occurring product (the MG-LAB279 strain or a bacterial cell component thereof) or two naturally occurring products (the MG-LAB279 strain and a bacterial cell component thereof). Water is directed to a beverage and is a naturally occurring product. Therefore, claim 14 is directed to a combination of two products of nature (the MG-LAB279 strain or a bacterial cell component thereof; water) or a combination of three products of nature (the MG-LAB279 strain; a bacterial cell component of the MG-LAB279 strain; water).
Under Step 2A, Prong One of the analysis, the nature-based composition of claim 14 is compared to its naturally occurring counterparts to identify markedly different characteristics based on structure, function, and/or properties. Because the products of nature (the MG-LAB279 strain and/or a bacterial cell component thereof; food or beverage such as water) 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 MG-LAB279 strain and/or a bacterial cell product thereof with a food or beverage (e.g., water, a product of nature) does not appear to markedly change any characteristic 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 14 recites ‘product of nature’ exceptions (Step 2A, Prong One: YES).
These judicial exceptions are not integrated into a practical application. The combination of the two or three products of nature (the MG-LAB279 strain and/or a bacterial cell component thereof; food or beverage such as water) does not set forth a practical application of the composition of claim 14. 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 14 does not include additional elements that are sufficient to amount to significantly more than the judicial exceptions. Because the two or three products of nature (the MG-LAB279 strain and/or a bacterial cell component thereof; food or beverage such as water) do not occur together in nature, then each product of nature in the composition of claim 14 is considered an ‘additional element’ to the others 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 water with Lactobacillus sakei or a bacterial cell component thereof was well-understood, routine, and conventional activity in culturing Lactobacillus sakei. This is evidenced by Lechiancole (Ann. Microbiol. 2002. 52: 257-274) which teaches optimization of media and fermentation conditions for the growth of Lactobacillus sakei (abstract), pointing out that media were prepared from stock solutions of the components and brought to volume with distilled water (page 261, first paragraph). Since the combination of the claimed products of nature (the MG-LAB279 strain or a bacterial cell component thereof as present in the bacteria; water directed to a beverage) is well-understood, routine, and conventional activity, then the combination of the claimed products of nature is not significantly more than the judicial exceptions (Step 2B: NO). As such, claim 14 is not eligible subject matter under 35 U.S.C. 101.
Claim 15: The claim recites a pharmaceutical product comprising the composition according to claim 2. As discussed above, claim 2 recites a naturally occurring product (the MG-LAB279 strain or a bacterial cell component thereof) or two naturally occurring products (the MG-LAB279 strain and a bacterial cell component thereof). The MG-LAB279 strain and/or a bacterial cell component thereof is directed to a pharmaceutical product given their inherent health benefits (e.g. immunostimulatory, etc.). Therefore, claim 15 recites a ‘product of nature’ exception (Step 2A, Prong One: YES).
This judicial exception(s) is not integrated into a practical application. The recitation of a pharmaceutical product does not set forth a practical application of the product(s) of nature. Thus, claim 15 does not recite any ‘additional element’ other than the judicial exception(s) that integrates the judicial exception(s) into a practical application (Step 2A, Prong Two: NO). As such, claim 15 is directed to judicial exception(s) (Step 2A: YES).
Claim 15 does not include additional elements that are sufficient to amount to significantly more than the judicial exception(s) because claim 15 sets forth a property inherent to the product(s) of nature (a pharmaceutical product) (Step 2B: NO). Accordingly, claim 15 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 § 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 2, 3, 5-7, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hong (J. Microbiol. Biotechnol. 2014. 24(12): 1629-1635).
Hong discloses lipoteichoic acid (LTA) prepared and purified from a Lactobacillus sakei strain (abstract; page 1630, left column, last paragraph and right column, first paragraph; Table 1 on page 1633). LTA is directed to a bacterial cell component of a Lactobacillus sakei strain. Therefore, the purified LTA of Hong is directed to a composition comprising a bacterial cell component of a Lactobacillus sakei strain, meeting limitations of the composition of instant claim 2.
Hong differs from the claimed invention in that Hong does not expressly disclose that the LTA is a bacterial cell component of Lactobacillus sakei strain MG-LAB279. However, the LTA of the Lactobacillus sakei strain of Hong appears to be the same as the LTA of the Lactobacillus sakei MG-LAB279 strain because they are bacteria of the same species, thus sharing properties with respect to their components. Therefore, Hong renders obvious instant claim 2.
Regarding instant claim 3, Hong teaches that it is supposed that the LTA of L. sakei is an immune booster like LPA which is a powerful immune-stimulating material (page 1633, right column). Therefore, the LTA of L. sakei (rendering obvious a bacterial cell component of L. sakei strain MG-LAB279) is rendered obvious as being immunostimulatory. As such, Hong renders obvious instant claims 3 and 15 (the purified LTA itself is directed to a pharmaceutical product given its health benefit of immunostimulation).
Regarding instant claim 5, since the LTA of L. sakei of Hong is an immune booster (see preceding paragraph), then it is obvious that it possesses the claimed property of virus infection preventing or treating. Therefore, instant claim 5 is rendered obvious.
Regarding instant claim 6, since the LTA of L. sakei of Hong is an immune booster since it dramatically increased pro-inflammatory cytokine production (page 1633, right column), then it is obvious that it is possesses the claimed property of being NK cell-activating. Therefore, instant claim 6 is rendered obvious.
Regarding instant claim 7, since the LTA of L. sakei of Hong is an immune booster since it dramatically increased pro-inflammatory cytokine production (page 1633, right column), then it is obvious that it is possesses the claimed property of being interferon λ production-promoting. Therefore, instant claim 7 is rendered obvious.
Regarding instant claim 14, since the LTA of L. sakei of Hong is an immune booster (page 1633, right column), then it would have been obvious to the person of ordinary skill in the art to administer it to a subject by providing the LTA in a food or beverage since they are well known as vehicles for administering nutrients/pharmaceuticals to a subject. Therefore, instant claim 14 is rendered obvious.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hong as applied to claims 2, 3, 5-7, 14, and 15 above, and further in view of You (J. Microbiol. Biotechnol. 2013. 23(10): 1357-1364).
As discussed above, Hong renders obvious claims 2, 3, 5-7, 14, and 15. Hong differs from claim 11 in that Hong does not expressly disclose that the purified LTA (rendering obvious a bacterial cell component of Lactobacillus sakei strain MG-LAB279) is a skin-improving composition.
You investigated whether the lipoteichoic acid (LTA) from Lactobacillus sakei, i.e., sLTA, has strong effects on anti-photoaging (page 1358, left column, fourth paragraph). You discusses this in the context of human skin being continuously exposed to ultraviolet (UV)-induced photoaging (abstract). It was determined that sLTA inhibits MMP-1 and MAPK signaling induced by UVA in normal human dermal fibroblasts (NHDFs) (abstract; page 1362, right column, last paragraph). Therefore, You concluded that sLTA appears to have the potential to dramatically suppress UVA-induced damage, having anti-photoaging properties (page 1363, left column, first paragraph).
Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to expect the purified LTA of Hong (rendering obvious a bacterial cell component of Lactobacillus sakei strain MG-LAB279) to suppress UVA-induced damage in skin and have anti-photoaging properties. This would have been expected based on You’s finding that the LTA from L. sakei has those effects. Anti-photoaging properties are directed to a skin-improving effect. Therefore, Hong in view of You renders obvious instant claim 11.
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yoshio (US 2019/0099456. Listed on IDS filed 11/12/24) discloses Lactobacillus sakei strains K1, K41, and K1185 (paragraph [0166]). It was suggested that there is a possibility that these three strains have the effect of promoting interferon λ production with respect to BDCA2 DC (paragraph [0172]). Therefore, Yoshio is relevant to the claimed invention in that Yoshio teaches an interferon λ production-promoting composition comprising a strain of Lactobacillus sakei and/or a bacterial cell component thereof (the strain itself comprises all bacterial cell components thereof) as an active ingredient. However, Yoshio differs from the claimed invention in that there is insufficient evidence to support a conclusion that any of the Lactobacillus sakei strains K1, K41, and K1185 of Yoshio is the claimed L. sakei strain MG-LAB279.
Kim (Nutrients. 2020. 12(11): 3573. 16 pages. Listed on IDS filed 11/12/24) discloses a heat-killed Lactobacillus sakei K040706 exerting immunostimulatory and anti-inflammatory activities in macrophages, cyclophosphamide (CYP)-treated mice, and dextran sulfate sodium-induced colitis mice (abstract). Therefore, Kim is relevant to the claimed invention in that Kim teaches an immunostimulatory composition comprising a Lactobacillus sakei strain and/or a bacterial cell component thereof (the heat-killed bacteria itself comprises all bacterial cell components thereof) as an active ingredient, as well as being an immunostimulatory composition that does not induce inflammation. However, Kim differs from the claimed invention in that there is insufficient evidence to support a conclusion that the Lactobacillus sakei K040706 strain of Kim is the claimed L. sakei strain MG-LAB279.
Lee (J. Microbiol. Biotechnol. 2016. 26(9): 1517-1526. Listed on IDS filed 11/12/24) discloses Lactobacillus sakei K101 (abstract). Production of IL-12 was significantly increased in L. sakei K101-treated splenocytes as compared with controls (abstract). Also, the study suggests that L. sakei K101 can be used for the treatment of immunosuppressed disorders (abstract). Therefore, Lee is relevant to the claimed invention in that Lee discloses a composition comprising a Lactobacillus sakei strain and/or bacterial cell component thereof (the bacteria itself comprises all bacterial cell components thereof) that is an immunostimulatory composition or suggests an interleukin-12p70 production-promoting composition (due to IL-12 production-promoting function).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN EMILY FERNANDEZ whose telephone number is (571)272-3444. The examiner can normally be reached 10:30am - 7pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Sef
/SUSAN E. FERNANDEZ/Examiner, Art Unit 1651
Prosecution Insights