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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/18/2025 has been entered.
Priority
This application claims benefit of priority to French Republic Patent Application No. FR1911895, filed 10/24/2019. This application is also a 371 of PCT/EP2020/078966 filed on 10/14/2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The Drawings filed on 04/20/2022 are accepted by the Examiner.
Amendments and Claim Status
In the reply filed on 09/18/2025, Applicant amended claim 13 and canceled claim 30.
Claims 13 and 15-29 are currently pending.
Claims 17-28 are withdrawn from consideration.
Claims 13, 15-16 and 29 are under examination.
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 13, 15-16 and 29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to a product of nature.
Claims 13, 15-16 and 29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a non-eligible natural product as supported below.
STEP 1: Is the claim to a process, machine, manufacture or composition of matter?
With regard to Step 1, the bacterial preparation as claimed in claims 13, 15-16 and 29 is a composition of matter.
Answer to STEP 1: Yes, the claims are directed to a product of nature.
STEP 2: Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)?
Step 2 comprises two, respective steps: Steps 2A Prong 1 and Step 2A Prong 2. Both steps together, provide the analysis for determining whether the claim recites a Judicial Exception (JE).
STEP 2A, PRONG 1: Is the claim ‘directed to’ an abstract idea, law of nature or natural phenomenon?
A claim product is ‘directed to’ a natural phenomenon/natural product if the product of the claim is not ‘markedly different’ when compared to its closest-occurring natural counterpart.
With regard to STEP 2A, PRONG 1:
The claims are directed to a bacterial preparation comprising a microorganism comprising Carnobacterium maltaromaticum deposited under the number CNCM I-5242, a microorganism comprising Carnobacterium maltaromaticum deposited under the number CNCM I-5243, at least one lactic acid fermenting agent and a ‘synthetic’ medium having components that are essential for the growth of bacteria. The instant Specification states a bacterial preparation means “a packaged composition of Carnobacterium maltaromaticum, said composition comprising a viable strain of Carnobacterium maltaromaticum and components that are essential for the growth of the bacteria, such as a source of carbon and of energy, a source of potassium and of phosphorous, a source of calcium, a source of magnesium, lipids, proteins or amino acid” (Specification, Page 4, Lines 8-12).
It is further noted the instant Specification states a ‘synthetic medium’ means “a medium into which individual components have been introduced which have been characterized and have undergone rigorous quantitative and qualitative checks” (Specification, Page 4, Lines 17-19). Undergoing ‘rigorous quantitative and qualitative checks’ does not materially change the component at all from its natural state. For example, carbon that has undergone quantitative and qualitative checks is still the same carbon prior to the checks. Thus, under the broadest reasonable interpretation, claim 13 is drawn to the microbe with other naturally occurring judicial exceptions, reading on the microbe in its natural environment. It is noted Carnobacterium maltaromaticum is a naturally occurring microorganism. For example, it can be found in fish, meat and dairy product, as taught by Afzal et al (Food Microbiology, 08/2010). Applicant indicates that the bacterial strains have been isolated, which means they are in a form or environment which does not occur in nature (Specification, Page 3, Lines 11-13). It is noted that isolating a natural microorganism, and then placing the isolated natural microorganism in a non-natural environment does not alter the structure of the microorganism. Additionally, isolating a carbon source, performing checks on said carbon source, and then placing the isolated carbon source in a non-natural environment does not alter the carbon in any way.
Applicant indicates the claimed C. maltaromaticum microbes and lactic acid-producing microbes do not naturally co-exist. Thus, it appears the ‘closest-occurring natural counterpart’ to the claimed invention appears to be each, individual organism as they exist in nature.
Thus, it appears that the microorganism comprising Carnobacterium maltaromaticum deposited under the number CNCM I-5242 and the microorganism comprising Carnobacterium maltaromaticum deposited under the number CNCM I-5243 are natural forms of natural strains that have been isolated and then included in the composition as claimed. As such, the composition of claim 13, which includes only a microorganism comprising Carnobacterium maltaromaticum deposited under the number CNCM I-5242, a microorganism comprising Carnobacterium maltaromaticum deposited under the number CNCM I-5243, a lactic acid fermenting agent and a carbon source, is deemed to be a natural product. It is noted Lactobacillus is a genera of bacteria which ferment lactic acid and is also naturally-occurring.
Since Applicants have not modified the microorganisms in any way from their naturally-occurring state, each claimed microorganism is expected to have the same characteristics as the microorganisms which occur in nature. Further, there is no evidence of record that demonstrates that adding these microorganisms together has any markedly different effects.
The claims have been considered as a whole, including all limitations, and the combination of all elements does not provide for any markedly different characteristics than the components do individually. The effects of combining the claimed elements would have the same structure and the same function as each individual element has as it exists in nature. Thus, the combination does not have any markedly different characteristics than the individual components themselves possess.
Answer to STEP 2A, PRONG 1: Yes, the claim is ‘directed to’ an abstract idea, law of nature or natural phenomenon.
STEP 2A, PRONG 2: Does the claim recite additional elements that integrate the natural product into a practical application?
‘Integration into a practical application’ according to the most recent PEG guidance:
Requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception.
Uses the considerations laid out by the Supreme Court and the Federal Circuit to evaluate whether the judicial exception is integrated into a practical application.
With regard to STEP 2A, PRONG 2:
Limitations the courts have found indicative that an additional element (or combination of elements) may have integrated the exception into a practical application include:
• An improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
• Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
• Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
• Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
• Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
The courts have also identified limitations that did not integrate a judicial exception into a practical application:
• Merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f);
• Adding insignificant extra-solution activity to the judicial exception, as discussed in MPEP § 2106.05(g); and
• Generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h).
The claims recite at least one lactic acid fermenting agent. As Applicant indicated lactic acid fermenting agents refers to bacteria that produce lactic acid and points to Table 2 as examples of such.
The only element claimed which is in-addition to the naturally-occurring bacteria and naturally occurring carbon source, is the fact that the bacteria and carbon have been added together in a mixture; however, this does not amount to imposing a meaningful limitation over the judicial exception as-claimed.
Answer to STEP 2A, PRONG 2: No, the claims do not recite additional elements that integrate the Judicial Exception into a practical application because the only additional element added to the two naturally-occurring bacteria is a food source for the bacteria, i.e., the carbon source. As stated above, bacteria require a carbon source to live and proliferate. Thus, adding a source of food (carbon) merely links the use of the claimed natural microorganisms to the culturing process, a process that is well known in the prior art. .
Answer to STEP 2A: Yes, the claims are directed to a Judicial Exception.
STEP 2B: Does the claim recite additional elements that amount to significantly more than the Judicial Exception?
With regard to Step 2B, the combination of microorganisms as instantly-claimed does not set forth significantly more than the judicial exception because it is well-understood, routine, and conventional to admix microorganisms together in food and pharmaceutical products. Additionally, the preparation further comprising carbon does not surmount the non-eligibility finding because the claimed microorganisms need a carbon source to live and proliferate and as such, the addition of food and such in a culture to maintain microorganisms adds no markedly different characteristics, does not add an inventive concept over the judicial exception, and does not offer significantly more than the claimed judicial exception as it is well-understood, routine, and conventional to culture the claimed microorganisms in a medium containing a carbon source to maintain viability of the microorganisms.
As such, the claims do not recite additional elements (i.e. mixing the claimed microorganisms together) that alone or together amount to significantly more than the judicial exception itself.
Regarding dependent claims 15-16 and 29, it is noted that these claims recite only elements that further characterize the natural product, or further natural components that can be included with the composition.
With regard to claim 15, it is noted the preparation may be in a concentrate as one of the embodiments and however, does not change the structure of the microorganism . A ‘concentrate’ is merely the removal of water, and bacteria naturally contain water. Thus, the removal of some amount of water to yield a ‘concentrate’ does not add anything to the claim in addition to the judicial exception.
With regard to claim 16, the preparation being a protective culture does not add anything in-addition to the judicial exception because this claim merely indicates that the C. maltaromaticum is part of a culture. This claim does not change or alter the naturally-occurring bacteria.
With regard to claim 29, the lactic acid fermenting agent, being Lactococcus lactis subsp. Cremoris, is a naturally-occurring strain and as such, for the reasons set forth above, does not add markedly different characteristics, does not impart any inventive concept over the judicial exception, and does not add significantly more than the judicial exception. Notably, this microbe is found in nature, such as in cheese, as evidenced by Cavanagh et al. (Food Microbiology, 11/11/2014).
Answer to STEP 2B: No, the claims do not recite any additional elements that amount to significantly more than the judicial exception because the addition of a food source, i.e., carbon, to the naturally-occurring microorganisms does not present significantly more as it is well-understood, routine and conventional to add a food source, such as carbon, to a culture medium comprising bacteria so that the bacteria can live and proliferate.
See Funk Bros., 333 U.S. 127 (1948).
For the forgoing reasons, the microorganism as claimed is not deemed to encompass patent eligible subject matter under 35 USC § 101.
35 USC § 101 – Response to Arguments
In the reply filed on 09/18/2025, Applicant argued amended claim 13 now recites a ‘synthetic medium’ which involves human intervention to optimize it for the growth and survival of bacterial strains and the optimization distinguishes it from the natural environment from which the organisms are typically found, rendering it non-natural.
Applicant’s arguments have been fully considered, but are not persuasive. As discussed above, delineating the medium as ‘synthetic’ does not materially change the medium. A carbon source that has been isolated and placed into another environment is identical to the same carbon source present in nature. As the carbon source is the same, there is no markedly different characteristics and the recitation of ‘synthetic medium’ does not change eligibility under 35 USC § 101. Additionally, there is no stated difference between the ‘synthetic’ and natural carbon source.
In the reply filed on 09/18/2025, Applicant argued the combination of the selected bacterial strains with the specifically formulated synthetic medium confers a functional and structural distinction over any naturally occurring product.
Applicant’s arguments have been fully considered, but are not persuasive. As stated above, the ‘synthetic medium’ is formulated with naturally occurring components. Thus, the function and structure of the components in the medium do not differ from the function and structure of the components in nature.
In the reply filed on 09/18/2025, Applicant argued combining microorganisms in food and pharmaceutical compositions is not arbitrary and requires more than what is well-understood, routine and conventional in the field.
Applicant’s arguments have been fully considered, but are not persuasive. As discussed below under the 35 USC § 102 rejections, Erkes et al. disclose a culture that comprises at least one lactic acid bacterial strain and a bacteriocin-producing strain, showing it is well known in the art that such strains can be mixed.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 13, 15-16 and 29 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Erkes et al. (US 20190029279 A1, 01/31/2019).
Regarding claims 13 and 29, Erkes et al. disclose a culture that comprises at least one class IIa bacteriocin-producing strain selected from Carnobacterium maltaromaticum, Carnobacterium pisicola, Carnobacterium divergens, Lactobacillus curvatus, Lactobacillus plantarum, Lactobacillus sakei, Lactococcus lactis, Leuconostoc carnosum, Leuconostoc gelidium, Pediococcus acidilactici, Pediococcus pentosaceus. (Claim 5 of Erkes et al.). Erkes et al. disclose the culture comprising at least one lactic acid bacterial strain is prepared by inoculating MRS broth with the bacteriocin-producing strain (Paragraph [0079]). MRS broth reads on multiple essential components for the growth of bacteria listed in instant claim 13. The culture, reading on a bacterial preparation, containing at least one strain, reading on 1 or more, of Carnobacterium maltaromaticum and Lactococcus lactis, and the MRS broth, anticipates instant claims 13 and 29.
While Erkes et al. did not specifically disclose the exact combination of bacteria, Erkes et al. did disclose a culture comprising the Markush group of Claim 5, which includes the claimed bacteria. Even though the claimed bacteria would have to be selected from said group, the combination of bacteria as-claimed is anticipated because one of ordinary skill in the art would readily envisage such a combination. See MPEP 2131.02(III), including In re Petering, 301 F.2d 676, 133 USPQ 275 (CCPA 1962).
Regarding claim 15, Erkes et al. disclose the culture is added in a concentration in the range of 1e+5 – 1e+9 CFU/G product, and if the culture comprises more than one strain, the numbers refer to each strain. It is noted Applicant defines the term ‘concentrate’ as a liquid containing a quantity of bacteria of more than 105 CFU.mL-1. Thus, the culture disclosed by Erkes et al. reads on a concentrate. Erkes et al. further disclose the culture comprising the bacterial strain/strains may be provided in any suitable form, such as frozen or in freeze dried form (Paragraph [0051]).
Regarding claim 16, as mentioned above regarding claim 13, Erkes et al. disclose a culture comprising one least one class IIa bacteriocin-producing strain from the strains listed above. It is noted the claimed protective culture is a composition containing live Carnobacterium maltaromaticum which may be added to food products in order to inhibit the growth of microorganisms which are pathogenic or toxic to humans or animals and are present in said food products (Specification, Page 6, Lines 1-5). As such, the claimed protective culture is an inherent characteristic of Carnobacterium maltaromaticum. Accordingly, the culture disclosed by Erkes et al. is deemed a protective culture as the preparation cannot be separated from its functional properties.
35 USC § 102 – Response to Arguments
In the reply filed on 09/18/2025, Applicant argued Erkes et al. do not disclose a synthetic medium having the growth components listed in amended claim 13.
Applicant’s arguments have been fully considered, but are not persuasive. As discussed above, delineating the medium as ‘synthetic’ does not materially change the medium. Applicant has not disclosed any means of making the medium components synthetic, just stated the components have undergone rigorous quantitative and qualitative checks. Again, this does not render the components ‘non-natural’ or synthetic. The components have not been changed, just ‘checked.’ Thus, the medium of Erkes et al. meets the limitations of amended claim 13.
Conclusion
Claims 13, 15-16 and 29 are rejected.
No claims are allowed.
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/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653