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
Claims 1-7 are pending and under consideration.
Withdrawn Rejections
Rejection of Claims 1-6 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn. Applicant amended the independent claims 1 and 6 and provided a persuasive argument, thereby obviating this rejection.
NEW - Claim Objections
(necessitated by amendments)
Claim 7 is objected to because of the following informalities: Bacillus sp., Lactobacillus pentosus, and Lactobacillus sakei should be in italics because binomial nomenclature for microorganism should be in italics. Appropriate correction is required.
NEW - Claim Rejections - 35 USC § 112
(necessitated by amendments)
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 1-7 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.
Claims 1 and 6-7 recite “wherein the supernatant or dried powder is present in an amount of 0.0001 to 50 wt% on a dry-weight basis.” Concentration is used to define how much of solute is present in solution. For example, 1%(w/w) NaCl solution means that 1g of NaCl (solute) is present in 100g of solution. However, “the supernatant or dried powder” recited by instant claims is solution comprising many components (solutes). Therefore, it is unclear what solute concentration Applicant intends to define by the wherein-clause.
Dependent claims are also rejected because they depend from claim 1 and do not cure the deficiency.
MAINTAINED - 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 1-7 are rejected under 35 U.S.C. 101, because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claims are directed to a judicial exception (natural phenomenon), specifically, the claims are drawn to a supernatant obtained by culturing bacterial strains of Bacillus sp. pfbarrier 01, Lactobacillus pentosus pfbio035, and Lactobacillus sakei subsp. sakei pfbio005. Furthermore, the claims do not integrate said judicial exception into practical application, and the claims do not recite additional elements that amount to significantly more than said judicial exception.
The 2019 Patent Subject Matter Eligibility Guidance (“Guidance”) provides a means of determining whether a particular claim is patent eligible under 35 U.S.C. 101. The Guidance requires an analysis of multiple steps, Steps 1, 2A, and 2B:
Step 1 - Following a determination of the broadest reasonable interpretation of a claim, is the claim drawn to a process, machine, manufacture, or composition of matter? If the answer to this inquiry is “Yes,” the analysis moves on to step 2A.
Step 2A - A two-prong analysis. For prong one, does the claim recite an abstract idea, law of nature, or natural phenomenon? If “Yes,” the analysis proceeds to prong two, which asks whether the claim recites additional elements that integrate the judicial exception into a practical application. If “No,” the analysis moves on to step 2B.
Step 2B - Does the claim recite additional elements that amount to significantly more than the judicial exception? If “No,” the claim is not eligible subject matter under 35 U.S.C. 101.
In the instant case, the claims are drawn to a composition, so the answer to Step 1 is “Yes.”
With respect to prong one of Step 2A, the answer is “Yes,” because as indicated above, the claims are drawn to a natural phenomenon, specifically, the claims are drawn to a supernatant obtained by culturing bacterial strains of Bacillus sp. pfbarrier 01, Lactobacillus pentosus pfbio035, and Lactobacillus sakei subsp. sakei pfbio005. The supernatant of the culture medium is a mixture of natural compounds released by bacterial strains, and therefore the supernatant itself is also natural product.
With respect to prong two of Step 2A, the claim does not recite additional elements that integrate the judicial exception into a practical application. Claim 2 recites “the composition inhibits the expression of matrix metalloproteinase-1 (MMP-1) gene and increases the expression of type 1 procollagen gene to improve skin wrinkles”. Claim 3 recites “the composition promotes the synthesis of hyaluronic acid to moisturize skin”. Claim 4 recites “the composition increases the expression of filaggrin gene to strengthen skin barrier”. Claim 5 recites “the composition promotes the regeneration of a wounded skin”. These limitations are functional characteristics of the claimed product. Because instant claims claim product, not process, these functional limitations of the claimed product do not recite active process steps of applying the claimed product into a practical application. Therefore, claims 2-5 do not recite additional elements that integrate the judicial exception into a practical application. Said limitations do not integrate the recited judicial exception, for example, by applying or using said judicial exception to effect a particular treatment for a disease or medical condition. Therefore, the answer to prong two of the Step 2A analysis is “No.”
With respect to Step 2B, instant claims recite only natural product of supernatant of bacterial culture medium, and do not recite any additional elements that amount to significantly more than the recited judicial exception. Accordingly, the answer to the Step 2B analysis is “No,” and therefore the claims are not eligible subject matter under 35 U.S.C. 101.
A claim that focuses on use of a natural principle must also include additional elements or steps to show that the inventor has practically applied, and added something significant to, the natural principle itself. See Mayo, 101 USPQ2d at 1966. Patents cannot be obtained on subject matter identified by the courts as being exempted from eligibility (i.e., laws of nature, natural phenomenon, and abstract ideas).
See the 2019 Revised Patent Subject Matter Eligibility Guidance and Federal Register https://www.federalregister.gov/documents/2019/10/18/2019-22782/october-2019-patent-eligibility-guidance-update; and FDsys.gov.
Response to Arguments
In the response filed on 1/13/2026, Applicant argued at page 5,
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Applicant's arguments have been fully considered but they are not persuasive. Whether the claimed product is a natural product or not is not determined by the process of preparing the natural product. If the claimed product is naturally existing product, then it is natural phenomenon. The supernatant of culture medium is just a mixture of many natural products released by bacterial strains in the culture medium. Therefore, instant composition is a natural product unless instant claims recite additional element which is a significantly more than the said natural phenomenon.
Applicant argued at page 5,
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Applicant's arguments have been fully considered but they are not persuasive. In contrast to Applicant’s argument, new claim 7 does not recite additional element which is significantly more than the natural product.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHEOM-GIL CHEONG whose telephone number is (571)272-6251. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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