DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
The claim set filed on 29 October 2024 contains claims 1-8, which are currently pending. Claims 1-8 will be examined on the merits herein.
Priority
The instant application is a CON of U.S. Application 18/416,083 (filed 18 January 2024) and claims priority to foreign application KR 2023-0165387 (filed 24 November 2023). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, because no certified translation of the foreign priority document was provided, the foreign priority claim has not been perfected. Therefore, for the purposes of searching the prior art, the effective filing date of instant claims 1-8 is 18 January 2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 29 October 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: on pg. 12, the description for FIG. 1 (“a base sequence of a 16S rRNA of a Lactobacillus paracasei GLU70 strain isolated in the present invention”) does not accurately describe the contents of FIG. 1. Appropriate correction is required.
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The attempt to incorporate subject matter into this application by reference to “Health Functional Food Act No.6727” is ineffective (1) because the root words "incorporate" and/or "reference" have been omitted, see 37 CFR 1.57(c)(1) and (2) because the subject matter referred to by the Health Functional Food Act No. 6727 is “essential material”, as it is used to define the claim 4 term “health functional food” on pg. 8, lines 5-9 of the instant specification. From MPEP 608.01(p)(I)(A): “‘Essential material’ is defined in 37 CFR 1.57(d) as that which is necessary to… (2) describe the claimed invention in terms that particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b)…. In any application that is to issue as a U.S. patent, essential material may only be incorporated by reference to a U.S. patent or patent application publication.” Because the reference Health Functional Food Act No. 6727 is not a U.S. patent or patent application publication, it may not be used to incorporate essential subject matter by reference.
The incorporation by reference will not be effective until correction is made to comply with 37 CFR 1.57(c), (d), or (e). If the incorporated material is relied upon to meet any outstanding objection, rejection, or other requirement imposed by the Office, the correction must be made within any time period set by the Office for responding to the objection, rejection, or other requirement for the incorporation to be effective. Compliance will not be held in abeyance with respect to responding to the objection, rejection, or other requirement for the incorporation to be effective. In no case may the correction be made later than the close of prosecution as defined in 37 CFR 1.114(b), or abandonment of the application, whichever occurs earlier.
Any correction inserting material by amendment that was previously incorporated by reference must be accompanied by a statement that the material being inserted is the material incorporated by reference and the amendment contains no new matter. 37 CFR 1.57(g).
Claim Interpretation - 35 USC § 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 1 recites the limitation, “Isolation step for isolating a Lactobacillus paracasei GLU strain with Accession Number KCTC13515BP from salted seafood”. This limitation meets all conditions of the three-prong test set forth above. Thus, this limitation has been interpreted as being limited to the corresponding description on pg. 12-13 of the instant specification, “To isolate lactic acid bacteria having a gluten-degrading ability from various types of salted seafood, various types of salted seafood were finely chopped aseptically, and 1 g thereof was taken, suspended in 9 ml of a sterilized saline solution (0.85% NaCl), and diluted stepwise, and smeared on an MRS solid medium containing 1% gluten. After culturing at 30 °C for 48 hours, only microorganisms that formed a clear zone, which is generated while degrading gluten, around the colonies that appeared were isolated.”
Claim 1 also recites the limitation, “Steps for cultivating the Lactobacillus paracasei GLU strain with Accession Number KCTC13515BP in a medium”. This limitation meets all conditions for the three-prong test set forth above. However, there is not a clear description of structure, materials, or acts in the specification which corresponds to the claim limitation (see also 35 U.S.C. 112(b) rejection below).
Claim 1 also recites the limitation, “Manufacturing step for manufacturing a composition comprising the Lactobacillus paracasei GLU70 strain with Accession Number KCTC13415BP, a culture solution thereof, a concentrate of the culture solution, or a dried product thereof as an active ingredient.” This limitation meets all conditions for the three-prong test set forth above. However, there is not a clear description of structure, materials, or acts in the specification which corresponds to the claim limitation (see also 35 U.S.C. 112(b) rejection below).
Claim Rejections - 35 USC § 112(b)
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 1-8 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.
Regarding claim 1 (upon which claims 2-6 depend), the “Isolation step” has been interpreted to encompass “various types of salted seafood were finely chopped aseptically, and 1 g thereof was taken,….” (pg. 12-13) However, it is unclear what is encompassed by the term “various types of salted seafood”. The term “various types” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In the interest of compact prosecution, the limitation has been interpreted such that any group of two or more different seafoods comprising salt meets the claim.
Claim 1 recites the limitation, “Steps for cultivating the Lactobacillus paracasei GLU strain with Accession Number KCTC13515BP in a medium”. This limitation invokes 35 U.S.C. 112(f), but it is unclear what description in the specification corresponds to the limitation. The specification teaches “the culture solution is a culture solution obtained by culturing a strain in a conventional medium” (pg. 5, lines 13-14) and “the isolated microorganisms were smeared on an MRS solid medium and cultured at 30°C.” (pg. 13, lines 4-5). Additionally, because the limitation recites “steps for…”, it is unclear whether the step is intended to be repeated more than once, or if the limitation is indicating more than one act necessary to cultivate the strain. In the interest of compact prosecution, the scope of the limitation is interpreted as smearing the isolated microorganisms on an MRS solid medium and culturing at 30°C, as described on pg. 13 of the specification.
Claim 1 recites the limitation, “Manufacturing step for manufacturing a composition comprising the Lactobacillus paracasei GLU70 strain with Accession Number KCTC13415BP, a culture solution thereof, a concentrate of the culture solution, or a dried product thereof as an active ingredient.” This limitation invokes 35 U.S.C. 112(f), but there is not sufficient description in the specification for “manufacturing a composition comprising the Lactobacillus paracasei GLU70 strain with Accession Number KCTC13415BP….” The specification describes manufacturing fermented foods (pg. 11), food or beverages (pg. 7), and functional food (pg. 8), but not the more general composition in the claims comprising Lactobacillus paracasei GLU70 strain with Accession Number KCTC13415BP. The specification also describes a “Manufacturing Example” in which colonies of isolated microorganisms “were suspended in a 20% glycerol solution and stored in a -80°C freezer for use.” (pg. 13, lines 5-6) None of the above descriptions describe manufacturing of a concentrate of the culture solution of a dried product thereof. In the interest of compact prosecution, the scope of the limitation is interpreted as suspending the colonies obtained from culturing the isolated strain in a 20% glycerol solution and storing at -80°C for use, as described on pg. 13 of the specification.
Claims 2-6 are also rejected as indefinite because they depend from claim 1 and do not obviate these issues.
Claim 4 recites the term “health functional food.” This term is defined in the instant specification as “food manufactured and processed using raw materials or ingredients with functionality that is useful to the human body in accordance with Health Functional Food Act No.6727, and refers to food that is ingested for the purpose of controlling nutrients with respect to the structure and function of the human body or obtaining useful health effects such as physiological effects.” (pg. 8, lines 5-9) The incorporation by reference of the Health Functional Food Act No. 6727 is improper because the subject matter referred to by the reference is necessary to “describe the claimed invention in terms that particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b)” (See para. 6 above and MPEP 608.01(p)(I)). Thus, the scope of the term “health functional food” is indefinite because the ingredients that can be used in the food are not properly defined by the claim or the specification. In the interest of compact prosecution, the term “health functional food” is interpreted using only the part of the definition that can be interpreted without the improper reference as referring to “food that is ingested for the purpose of controlling nutrients with respect to the structure and function of the human body or obtaining useful health effects such as physiological effects.” (pg. 8, lines 7-9)
Claim 7 (upon which claim 8 depends) recites, “An antibacterial method against pathogenic microorganisms comprising a composition according to claim 1.” However, claim 1 is drawn to a method, not a composition. Additionally, the scope of the method is unclear because the claim does not recite any active steps indicating how the method is actually practiced (see MPEP 2173.05(q)). Thus, the scope of claim 7 and its dependent claim 8 cannot be determined.
Claim Rejections - 35 USC § 112(a)
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 1-8 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.
It is apparent that Lactobacillus paracasei GLU70 with Accession Number KCTC13415BP is required to practice the claimed invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of Lactobacillus paracasei GLU70 with Accession Number KCTC13415BP.
The process disclosed in the specification does not appear to be repeatable, it is not clear that the invention will work with commonly available material and it is not apparent if the biological materials considered necessary to make and use the invention is both known and readily available to the public. The instant specification teaches that the claimed strain was isolated from “various types of salted seafood,” (pg. 12, lines 22-23) but does not specifically teach what salted seafood was used or its source. Therefore, one of ordinary skill in the art would not be able to repeat the exact method in order to obtain the claimed strain.
It is noted that Applicants have deposited biological material but there is no indication in the specification as to public availability.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
If the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration by Applicant or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing that:
(a) During the pendency of the 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 enforceable life of the patent, whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
Claims 1-8 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 focus of the enablement inquiry is whether everything within the scope of the claim(s) is/are enabled, at the time of filing, without requiring undue experimentation to make or use the invention. The factors to be considered in determining whether a disclosure would require undue experimentation include: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01.
The breadth of the claims: With respect to claim breadth, the standard under 35 U.S.C. §112(a) or 35 U.S.C. §112, first paragraph, entails the determination of what the claims recite and what the claims mean as a whole. The claims are drawn to a method for manufacturing a composition comprising Lactobacillus paracasei GLU70 strain with accession number KCTC13415BP.
Claim 1 recites, “Isolation step for isolating a Lactobacillus paracasei GLU70 strain with Accession Number KCTC13415BP from salted seafood.” The scope of this limitation is interpreted using the corresponding description on pg. 12-13 of the instant specification, “To isolate lactic acid bacteria having a gluten-degrading ability from various types of salted seafood, various types of salted seafood were finely chopped aseptically, and 1 g thereof was taken, suspended in 9 ml of a sterilized saline solution (0.85% NaCl), and diluted stepwise, and smeared on an MRS solid medium containing 1% gluten. After culturing at 30 °C for 48 hours, only microorganisms that formed a clear zone, which is generated while degrading gluten, around the colonies that appeared were isolated.” The scope of “various types of salted seafood” encompasses any salted seafood product from any source.
The state of the prior art and the level of predictability in the art: Kim and Kim (2023, LWT; herein “Kim”) explored the microbial diversity of samples from 10 different salted seafood products collected in different seasons (Abstract). Kim found that the relative abundance of Lactobacillaceae varies greatly among the different salted seafood products (Fig. 5). On the genus level, Lactobacillus abundance varies among the different salted seafood products, with some products having almost no detectable Lactobacillus sp. (Fig. 6) Furthermore, in salted seafood products that do contain Lactobacillus sp., the abundance of Lactobacillus sp. changes based on the season in which the product was sampled (Fig. 6).
Based on the prior art, one of ordinary skill in the art would recognize that the claimed Lactobacillus paracasei GLU (KCTC13415BP) cannot be isolated from any given combination of salted seafood products.
The amount of direction provided by the inventor and the existence of working examples: The instant specification teaches that the claimed Lactobacillus paracasei GLU70 with accession number KCTC13415BP was isolated from “various types of salted seafood” (pg. 12-13). However, the specification does not provide details on the types of salted seafood products used, their source, or the conditions in which they were sampled. Therefore, the specification does not provide enough information with which one may overcome the known unpredictability in the art.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure: The standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success. A patent is granted for a completed invention, not the general suggestion of an idea (MPEP 2164.03 and Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004)). The instant specification is not enabling for the claimed invention because one cannot follow the guidance presented therein, or within the art at the time of filing, and perform the claimed method without first making a substantial inventive contribution.
In order to practice the claimed method, one of ordinary skill in the art would have to determine what salted seafood products are likely to contain the claimed Lactobacillus strain before isolating the bacteria, but there is no teaching in the specification or the art indicating from what salted seafood product the strain may be obtained. While the art teaches that some salted seafood products have a greater relative abundance of Lactobacillus sp. than others, the abundance of Lactobacillus sp. varies based on the source of the product and the season in which it was obtained; furthermore, the presence of the Lactobacillus genus in a given product is not necessarily indicative of the presence of the claimed Lactobacillus paracasei GLU70 strain with accession number KCTC13415BP. Thus, in order to use the method as claimed, one of ordinary skill in the art would need to determine what salted seafood products contain the claimed Lactobacillus paracasei GLU70 (KCTC13415BP), which would go beyond what is routine in the art and would require undue experimentation.
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 7-8 are 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 claim 7 (upon which claim 8 depends) is not drawn to a method because the claim does not recite any active steps, and it is not drawn to a composition because claim 1 (from which claim 7 depends) recites a method, not a composition. The claims amount to a “use” claim, which is not patent-eligible. See 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. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 ").”
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 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cho and Noh (KR 2020-0099311; cited in IDS; herein “Cho”).
Regarding claim 1, Cho teaches a method comprising isolating the lactic acid bacteria Lactobacillus paracasei GLU70 with accession number KCTC13415BP comprising aseptically chopping various salted seafood products, of which 1 g was suspended in 9 ml of sterile physiological saline (0.85% NaCl), serially diluted, and plated on MRS solid media containing 1% gluten (para. 21, 42, and 44). Cho teaches that only microorganisms that form a clear zone around the colony that appeared after incubation at 30°C for 48 hours were isolated (para. 44). Cho teaches steps for cultivating the microorganism comprising plating the isolated microorganisms on MRS solid medium and culturing at 30°C (para. 44). Next, Cho teaches suspending the colonies in a 20% glycerol solution and storing the composition in a -80°C freezer for use (para. 44).
Regarding claim 2, Cho teaches that Lactobacillus paracasei GLU70 (KCTC13415BP) compositions is helpful in treating digestive disorders through changing intestinal bacterial flora (para. 82), i.e., the compositions are probiotic compositions.
Regarding claims 3-4, Cho teaches a food additive composition (i.e., a food composition) containing the Lactobacillus paracasei GLU 70 strain (KCTC13415BP) (para. 12).
Regarding claims 5-6, Cho teaches that the Lactobacillus paracasei GLU70 strain may be used in gluten fermentation (para. 21), demonstrating that the isolated strain composition is capable of being used as a starter composition in the manufacturing of fermented food.
Additionally, regarding claims 2-6, these claims recite intended uses for the composition made by the method of claim 1, none of which limit the structure of the composition, affect the method by which it is produced, or recite additional steps to the method of claim 1. A recitation of the intended use of the claimed composition must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY M MORGAN whose telephone number is (703)756-5388. The examiner can normally be reached M-F 9-5 ET.
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/BAILEY M MORGAN/
Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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