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 .
Applicant’s response filed 10/02/2025 has been received and entered into the case. Claims 1-7, 10, 11, 14, 19, 21-26 are pending. Claims 1-7, 10, 11, 21-26 are withdrawn. Claims 14 and 19 have been considered on the merits herein.
The rejection of Claim(s) 14, 18, 19, 20 under 35 U.S.C. 103 as being unpatentable over Saraivaa et al. (Medical res. Archives, 2016, IDS) in view of Kawakami et al., (US2010/0021445 A1) and WO2016/124642, and
Claim(s) 14, 18, 19, 20 under 35 U.S.C. 103 as being unpatentable over Lu et al. (Czeh J. Food Sci., 2009) in view of Kawakami et al., (US2010/0021445 A1) and WO2016/124642 are withdrawn in light of applicants claim amendments and arguments.
All arguments and amendments have been considered.
Maintained rejections
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 14, 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s) compositions comprising a cultured Lactococcus lactis strain (specifically CNCM I-5388), or cell fractions thereof, with free glutamate, thus products of nature. The specification indicates that the strains are of dairy origin from raw milk and whey, often found in cheese and thus, are naturally occurring bacteria. Further glutamate is naturally occurring in cheese, for example, and there is no indication that the mixture of Lactococcus with free glutamate has characteristics different from the naturally occurring counterparts. There is no indication or way to tell that the claimed cultured L. lactis bacteria in the composition have markedly different characteristics, i.e., structural, functional, or otherwise, that are different from the naturally occurring bacteria. The wherein clause of “wherein said L. lactis strain produces…in a time of culture comprised between 7 hours and 8 hours” is a result of culture conditions. The claims are drawn to a composition and not a method of culture; however, when said strain is cultured under certain conditions, i.e., with free glutamate (as disclosed in applicants specification), the cells necessarily produce GABA and GAD and thus is a property of the culture conditions.
This judicial exception is not integrated into a practical application because the claims do not include any additional features (in the compositions) and thus the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the product of nature claims does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state. “If the claim includes a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, then the claim is directed to a ‘product of nature’ exception (Step 2A: YES), and requires further analysis in Step 2B to determine whether any additional elements in the claim add significantly more to the exception and do they integrate the exception into a practical application. It is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart.” MPEP 2106.04(b)(ll). “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis.
Here, the claims are directed towards a composition comprising a cultured bacterial strain with free glutamate (also naturally occurring) and a cell fraction (isolated) of said bacterial strain. The cell fraction/or lysed bacteria does not change the product enough to make it different from what exists in nature. In the case of Myriad, the isolation resulted in a different structural characteristic; however otherwise, the isolated compound was structurally identical as well as having the same functional characteristic, thus the product was not markedly different from its naturally occurring counterpart and is directed to a product of nature. Since claims encompass naturally occurring bacterial cells, for step 2A “there is no need to perform the markedly different characteristics analysis because the limitation is by definition directed to a naturally occurring product and thus falls under the product of nature exception.” The free glutamate together in the composition does not display markedly different characteristics compared to the naturally occurring counterparts. Thus, the claim is directed to a judicial exception. Next, one must evaluate whether the claims as a whole integrate the judicial exception into a practical application, thereby imposing a meaningful limit on the judicial exception. Thus, one must identify whether there are any additional elements recited in the claim beyond the judicial exception. In the instant claims, there is not a practical application beyond the judicial exception.
The claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claim(s) 14, 19 is/are determined to be directed to a product(s) of nature.
For these reasons the claims are rejected under section 101 as being directed tonon-statutory subject matter.
New rejection necessitated by amendment
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 19 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 19 recites the limitation "the total lysate". There is insufficient antecedent basis for this limitation in the claim. Further, the claim has been amended to include that the cell fraction comprises lysed L. lactic cells, yet further down in the claim states that the cell fraction comprises a lysate of…dry weight of said …strain. It is not clear what the cell fraction contains, i.e. whether it is lysed cells and a lysate or just cells. It should be noted that a lysate does not contain cells but rather is the liquid containing the content of the lysed cells.
Response to Arguments
Applicant's arguments filed 10/2/2025 have been fully considered but they are not persuasive. Regarding the 101 rejection, applicants argue that the amended claims include free glutamate formulated for administration to an individual in an amount, and comprises an amount of the bacterial strain, and is thus not a product of nature. As stated above, both Lactococcus lactis and free glutamate can be found in nature, for example in dairy products such as cheese and limitations drawn to amounts do not does not display markedly different characteristics compared to the naturally occurring counterparts. Markedly different characteristics can be expressed as the product' s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis. Here, in the claims, the invention is drawn to a composition comprising a cultured L. lactis strain selected from CNCM I-5388 with free glutamate, and the composition comprises a concentration of the bacteria and is a pharmaceutical, nutritional, food or medicament composition. The “formulated for administration” does not provide how the free glutamate is different, as the formulation could comprise water as a carrier for example, which is also naturally occurring. Additionally, amounts do not provide for a markedly different characteristic from the nature-based product. It was suggested to applicants representative in the interview on 7/10/2025 that the addition of a pharmaceutical carrier (other than water or naturally occurring substance) would advance prosecution.
Conclusion
NO claims are 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 TIFFANY MAUREEN GOUGH whose telephone number is (571)272-0697. The examiner can normally be reached M-Thu 8-5.
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/TIFFANY M GOUGH/ Examiner, Art Unit 1651
/MELENIE L GORDON/ Supervisory Patent Examiner, Art Unit 1651