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 1-11 are pending and examined on the merits.
Biological Material
It is noted that paragraph [000120] of the originally filed specification complies with MPEP 2404.01 regarding the deposit of biological materials.
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5 recites “compositing” in line 3 which is a misspelling of the word “composition.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is 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 4 recites the limitation "the said lysate" in line 6. There is insufficient antecedent basis for this limitation in the claim. The steps of claim 4 do not recite any step of lysing/disrupting the strain body to obtain a lysate, so the recitation of “the said lysate” in line 6 lacks antecedent basis.
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 5-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the methods of improving skin inflammation, improving skin allergies, promoting skin immunity, or soothing skin (claims 5 and 11), regulating skin microorganisms (claims 6-8), or treating skin inflammation, skin allergy, or immune skin disease (claims 9 and 10) comprising administering a composition comprising at least one of the strain of claim 1 and its lysate to a subject, does not reasonably provide enablement for the methods of improving skin inflammation, improving skin allergies, promoting skin immunity, or soothing skin (claims 5 and 11), regulating skin microorganisms (claims 6-8), or preventing or treating skin inflammation, skin allergy, or immune skin disease (claims 9 and 10) comprising administering a composition comprising at least one of culture medium, extract of culture medium, and fermentation medium to a subject. Additionally, the specification does not reasonably provide enablement for preventing skin inflammation, skin allergy, or immune skin disease (claims 9 and 10) comprising administering a pharmaceutical composition comprising at least one of the strain of claim 1 and its lysate to a subject. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention. The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Minerals Separation Ltd. v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? The claimed invention must be enabled so that any person skilled in the art can make and use the invention without undue experimentation.
Regarding undue experimentation, In re Wands, 8 USPQ2d 1400, at 1404 (Fed. Cir. 1988) states:
Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. (Citations omitted).
These factors are considered for determination of whether a disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue.” The claimed invention must be enabled so that any person skilled in the art can make and use the invention without undue experimentation.
The breadth of the claims is broad with respect to the contents of the cosmetic composition (claims 5-8), the pharmaceutical composition (claims 9-10), and the health functional food composition (claim 11). The “culture medium,” “extract of culture medium,” and “fermentation medium” are each broad in scope. The originally filed specification does not narrow the definition of the term “culture medium” because it uses the phrasing “may mean” (paragraph [00024]). Therefore, the terms “culture medium” and “fermentation medium” are given their plain meaning, which are broad. Since the term “culture medium” is broad, then the term “extract of culture medium” is broad. Moreover, the claims do not require that the “culture medium,” the “extract of culture medium,” or the “fermentation medium” are of the strain of claim 1. Therefore, the culture medium and the fermentation medium of the compositions that are administered to a subject as recited in the claims are directed to any culture medium or any fermentation medium for any microorganism or cellular material (e.g., mammalian cells). The scope is broad given the wide range of nutrient and/or fermentation requirements for microorganisms and mammalian cells.
Additionally, the amount of direction or guidance presented in the specification is limited with respect to what is required for the culture medium, extract of culture medium, and fermentation medium so that, when any one of them is administered to a subject, they yield the claimed effects of improving/preventing/treating skin inflammation (claims 5 and 9-11), improving/preventing/treating skin allergies (claims 5 and 9-11), promoting skin immunity (claims 5 and 11), soothing skin (claims 5 and 11), regulating skin microorganisms (claims 6-8), and preventing or treating immune skin disease (claims 9 and 10). There is insufficient description, specifically the components and their concentrations, for the wide scope of culture and fermentation media (as pointed out above, for any microorganism or mammalian cell) that was determined as having the claimed therapeutic or preventative effects on skin of a subject.
The nature of the invention, improving skin inflammation, improving skin allergies, promoting skin immunity, or soothing skin (claims 5 and 11), or preventing or treating skin inflammation, skin allergy, or immune skin disease (claims 9 and 10), is complex. As evidenced by Ujiie (Frontiers in Medicine. 2022. 9: Article 875492. 30 pages. Published June 9, 2022), chronic skin inflammation has many causes, with the most frequent chronic inflammatory skin diseases being driven by a complex interplay of genetics and environmental factors (page 1). In reviewing the broad range of chronic inflammatory skin diseases, which include autoimmune skin diseases (see page 9, right column, second paragraph through page 14, right column, fourth paragraph), Ujiie concluded there are a multitude of challenges for the diagnosis and treatment of chronic skin inflammation, which are different for each disease (page 19, left column, last paragraph). Also, Campanati (Biomedicines. 2022. 10(5): 950. 5 pages. Published April 20, 2022) points out that inflammatory and immune-mediated diseases of the skin (s-IMID) represent a spectrum of diseases, which are highly variable in terms of clinical expression, prognosis, complications, and response to therapy (page 3, last paragraph). Therefore, Ujiie and Campanati demonstrate the difficulty in obtaining the effects of claims 5 and 9-11 in a subject.
Given the variety of only a select number of autoimmune skin diseases reviewed by Ujiie (included in the selected diseases in Table 1 on page 3; page 9, right column, second paragraph through page 14, right column, fourth paragraph), then a large amount of experimentation would be required to determine the success of the pharmaceutical composition of claim 9 (pharmaceutical composition comprising at least one of the strain of claim 1, its lysate, culture medium extract of culture medium, and fermentation medium) in preventing any and all known autoimmune skin diseases, in addition to determining the efficacy of the pharmaceutical composition of claim 9 in preventing skin inflammatory and skin allergy.
Additionally, the specification as filed fails to provide any working example demonstrating that a culture medium, an extract of a culture medium, or a fermentation medium is effective in improving skin inflammation, improving skin allergies, promoting skin immunity, or soothing skin (claims 5 and 11), regulating skin microorganisms (claims 6-8), or preventing or treating skin inflammation, skin allergy, or immune skin disease (claims 9 and 10). Also, the specification as filed fails to provide any working example demonstrating that the strain of claim 1 or its lysate is effective in preventing skin inflammation, skin allergy, or immune skin disease.
Given the breadth of the claims, the amount of direction or guidance presented, the nature of the invention, the quantity of experimentation necessary, and the absence of any working example, then undue experimentation would be required to perform the full scope of the claimed invention. Accordingly, claims 5-11 are rejected under 35 U.S.C. 112(a).
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 1-3 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 Lacticaseibacillus rhamnosus ICL-46 strain deposited under accession number KCTC15702BP. According to the originally filed specification, the strain was isolated from oats (Example 1, paragraphs [00084]-[00089]). Since the strain was isolated from oats, then the ICL-46 strain is a naturally occurring product. As such, 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 (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 that the strain is isolated from oat (Avena sativa). The isolation of the strain from oat does not confer any markedly different characteristic on the ICL-46 strain (naturally occurring product). Therefore, claim 2 recites a ‘product of nature’ exception (Step 2A, Prong One: YES).
This judicial exception is not integrated into a practical application because the isolation of the ICL-46 strain from oat does not set forth a practical application of the product of nature. Thus, the ‘additional element’ of claim 2 (strain isolated from oat) does not integrate 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. Prior to the Applicant’s invention and at the time of the filing of the application, the isolation of lactic acid bacteria such as Lacticaseibacillus bacteria was well-understood, routine, and conventional in the field of lactic acid bacteria. This is evidenced by Coeuret (Lait. 2003. 83: 269-306) which discloses that several elective and selective media have been developed for the isolation and counting of Lactobacillus species for the differential counting of mixed populations of lactic acid bacteria (page 272, right column, first paragraph). Also, Coeuret teaches that lactobacilli are generally isolated on rich media such as MRS, which is routinely used for the isolation and counting of lactobacilli from most (fermented) food products (page 272, right column, second paragraph). Since the isolation of Lactobacillus species is well-known and routine as indicated in Coeuret, then the isolation of a Lacticaseibacillus rhamnosus (i.e. Lactobacillus rhamnosus) strain, which is the additional element of claim 2, was well-understood, routine, and conventional activity. Therefore, the additional element of claim 2 does not amount to significantly more 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 recites that the strain of claim 1 comprises 16S rRNA of SEQ ID NO: 1. This is directed to an inherent property of the claimed ICL-46 strain. Therefore, claim 3 is rejected under 35 U.S.C. 101 on the same basis as parent claim 1.
Notice Re: Prior Art Available Under Both 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 1, 2, and 4-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lu (WO 2022/199660. English equivalent US 2024/0165015 cited below), as evidenced by Result 2 of SEQ ID NO: 1 search in the Published_Applications_NA_Main Database (Search performed August 17, 2026).
Lu discloses Lactobacillus rhamnosus 11-7 (paragraph [0012]). The ferment lysate of the 11-7 strain of Lu can inhibit the reproduction and growth of pathogenic bacteria, improve skin immunity, and significantly regulate the skin micro-ecological environment (paragraph [0013]).
As recited in instant claim 3, the Lacticaseibacillus rhamnosus ICL-46 strain comprises 16S rRNA of SEQ ID NO: 1. Lu discloses that the Lactobacillus rhamnosus 11-7 strain has a 16S rDNA as shown in their SEQ ID NO: 3 (paragraph [0138]). As evidenced by Result 2 of SEQ ID NO: 1 search in the Published_Applications_NA_Main Database, SEQ ID NO: 3 of Lu (i.e., U.S. Application No. 18/283,926) has 99.9% sequence similarity to SEQ ID NO: 1 of the instant application, wherein there is a match of 1444 residues and a mismatch with 1 residue.
It appears that Lactobacillus rhamnosus 11-7 (i.e., Lacticaseibacillus rhamnosus 11-7) strain is the claimed Lacticaseibacillus rhamnosus ICL-46 strain because they are bacteria of the same species with the 11-7 strain having a 16S rRNA sequence with a very high similarity (99.9%) to SEQ ID NO:1 of the claimed ICL-46 strain with 1444 residue matches and only 1 residue mismatch, and they share the following properties: regulate skin microorganisms (as in instant claim 6) which suppresses the growth of skin harmful bacteria (as in instant claim 7), and promote skin immunity (as in instant claims 5 and 11). In having a 16S rRNA sequence having 99.9% sequence similarity to SEQ ID NO: 1 of the claimed ICL-46 strain, then the 11-7 strain of Lu would appear to be identical to the claimed ICL-46 strain, having the same properties as the ICL-46 strain through the expression of a nearly identical nucleic acid sequence. Therefore, Lu renders obvious instant claims 1 and 2 (product-by-process claim; the 11-7 strain is directed to the claimed ICL-46 strain regardless of the process by why they are obtained).
Regarding instant claim 4, Lu discloses obtaining a ferment lysate by first inoculating the 11-7 strain into a fermentation medium for fermentation until there is no residual saccharide to obtain a first fermentation broth (paragraphs [0068]-[0069]). This is directed to a method for preparing a lysate of the strain of claim 1, comprising the steps of instant claim 4 of inoculating the strain of claim 1 into a medium (the fermentation medium of Lu) and then culturing it to obtain a strain culture medium (the first fermentation broth of Lu). Then, Lu teaches centrifuging the first fermentation broth and removing the supernatant to obtain fermentation bacterial cells (paragraph [0069]). This is directed to the step of instant claim 4 of centrifuging the said culture medium (the fermentation broth of Lu) to separate the strain body (the fermentation bacterial cells of Lu) and a supernatant. Then, Lu teaches performing enzymolysis of the fermentation bacterial cells to obtain a ferment lysate (paragraph [0070]). The ferment lysate is directed to the lysate of the strain body of instant claim 4. Additionally, in one embodiment, the supernatant obtained after centrifugation of the first fermentation broth is filtered through a filter membrane to obtain a second fermentation broth (paragraph [0090]). Further still, the second fermentation broth is used for suspending the debris of bacterial cells after enzymolysis (paragraphs [0092] and [0094]). The debris of bacterial cells after enzymolysis is directed to a ferment lysate, and the second fermentation broth is directed to the supernatant. Therefore, the teaching of suspending the debris of bacterial cells in the second fermentation broth is directed to the step of instant claim 4 of mixing the said lysate of the strain body (the debris of bacterial cells after enzymolysis of Lu) and the supernatant (the second fermentation broth of Lu) to obtain a strain lysate. As such, Lu renders obvious instant claim 4.
Regarding instant claims 5-8, Lu discloses that the ferment lysate conforms to characteristics of cosmetic raw materials (paragraph [0117]), and the ferment lysate is used in the field of cosmetics (paragraph [0118]). Therefore, Lu discloses a cosmetic composition comprising the lysate of the strain of instant claim 1 (the ferment lysate of the 11-7 strain of Lu). Additionally, the ferment lysate improves skin immunity (abstract). It would have been obvious to the person of ordinary skill in the art to administer the cosmetic composition comprising the ferment lysate of Lu to a subject in order to obtain the effect taught by Lu of improving skin immunity. Therefore, Lu renders obvious instant claim 5 (lysate). Regarding instant claims 6-8, Lu also teaches that the ferment lysate regulates skin microecology, and can strongly inhibit the reproduction and growth of pathogenic bacteria (abstract). It would have been obvious to the person of ordinary skill in the art to administer the cosmetic composition comprising the ferment lysate of Lu to a subject in order to obtain the effect taught by Lu of regulating skin microecology, strongly inhibiting the reproduction and growth of pathogenic bacteria. Therefore, Lu renders obvious instant claims 6 (lysate) and 7. Further regarding instant claim 8, Lu teaches that their ferment lysate can inhibit the growth of pathogenic bacteria such as Staphylococcus aureus and Pseudomonas aeruginosa (paragraph [0188]). Therefore, instant claim 8 is rendered obvious.
Regarding instant claims 9 and 10, Lu teaches that the ferment lysate of the 11-7 strain improves skin immunity (abstract). It would have been obvious to the person of ordinary skill in the art to administer the ferment lysate of the 11-7 strain (directed to a pharmaceutical composition comprising a lysate of the strain of instant claim 1) to a subject in order to treat an immune skin disease because the ferment lysate of Lu improves skin immunity. Therefore, instant claim 9 is rendered obvious. Further regarding instant claim 10, Lu does not expressly disclose that their ferment lysate (directed to the claimed pharmaceutical composition) inhibits or reduces the expression of at least one of COX-2 and iNOS; or inhibits or reduces the release of β-hexosaminidase. However, since the ferment lysate of Lu is directed to the claimed lysate of the strain of instant claim 1, then the ferment lysate of Lu necessarily possesses the properties of the claimed lysate of the strain of instant claim 1, including possessing the properties recited in instant claim 10. Therefore, instant claim 10 is rendered obvious.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Sef
/SUSAN E. FERNANDEZ/ Examiner, Art Unit 1651
Prosecution Insights