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 amendment and remarks filed 5/13/2026 are acknowledged. Claims 20 and 52 are amended. Claims 24 and 55 are cancelled. New claims 57-58 are added. Claims 1, 3-5, 7-9, 12-14, 16, 19-22, 52-53, and 57-58 are pending.
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 9/15/2025 is acknowledged.
Claims 1, 3-5, 7-9, 12-14, 16, and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 20-22, 52-53, and 57-58 are currently under examination.
Claim Rejections Withdrawn
The rejection of claims 24 and 55 under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more is withdrawn. The cancellation of the claims renders the rejection moot.
The rejection of claims 24 and 55 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn. The cancellation of the claims renders the rejection moot.
The rejection of claims 20-22, 24, 52-53, and 55 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as containing 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skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention is withdrawn in light of applicant’s statements with regard to the deposited strain.
The rejection of claims 24 and 55 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the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention is withdrawn. The cancellation of the claims renders the rejection moot.
The rejection of claims 24 and 55 under 35 U.S.C. 102(a)(1) as being anticipated by Krapez (Masters Thesis; IDS filed 8/23/2023) is withdrawn. The cancellation of the claims renders the rejection moot.
Claim Rejections Maintained
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 20-22, 52-53, and newly submitted claims 57-58 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more, for the reasons set forth in the previous office action. The claim(s) recite(s) B. subtilis strain PS-216, which is a natural bacterial strain. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements also include natural products that do not change the nature of the bacterial strain. Some claims include pharmaceutical or agricultural excipients. This would include water, which does not alter the bacteria. Some claims include a food ingredient. This would include various minerals or starches, which also do not alter the characteristics of the bacteria. In addition, a particular minimum number of cells does not alter the functioning of the cells.
Applicant argues:
1. That a claim to a manufacture or composition of matter made from a natural product is not directed to the natural product where it has different characteristics and the potential for significant utility.
2. That the Federal Circuit has affirmed that where natural products have been isolated and incorporated into a dosage form with particular characteristics, these characteristics provide significant utility, and the claimed matter is patent eligible.
3. That, while the bacterial strain is natural, food or probiotic compositions are not found in nature since such compositions are carefully mixed to comprise a balanced proportion of the required nutrients, so the animal, such as poultry, can grow and develop on such food and probiotic compositions as the sole source of food or feed (i.e., the compositions have a significant utility). A food or a probiotic composition having this ability is not found in nature. Further, in nature there is not found any food or feed composition containing at least 1x103 CFU of B. subtilis PS-216 per kg of composition. Thus, the compositions recited by claims 20 and 52 and the corresponding dependent claims contain isolated natural products incorporated into a dosage form and have a significant utility, therefore they do not constitute a judicial exception and rather refer to subject matter that is patent eligible.
Applicant’s arguments have been fully considered and are not persuasive for the following reasons:
Regarding argument 1 and 3, there is nothing in the claim requiring a balanced proportion of nutrients. The item is only required to have the bacterial strain (at the small dose of 1000 cells per kg) and some ingredient that can be used in food. As stated above, a mixture of salt water and bacteria is sufficient to meet the broadest claims. No special utility is added by this combination.
Regarding argument 2, the case applicant refers to is a case involving method claims which have an entirely different set of considerations. Therefore, the case law does not say what applicant suggests and is not relevant.
35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 20-22, 52-53, and newly submitted claims 57-58 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 written description requirement for the reasons set forth in the previous office action. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to food and probiotic compositions comprising B subtilis PS216 or a derivative thereof having all of the identifying characteristics of B subtilis PS216, and either a food ingredient or a pharmaceutical or agricultural excipient
The specification discloses the strain B subtilis PS216, which was isolated from soil in Slovenia. Some of the characteristics of this bacteria are described in the instant specification. However, the claims require a derivative of this strain having all of the identifying characteristics of PS216. Neither the art nor the specification does not describe all of the identifying characteristics of the strain. Additionally, there is no description in the specification of any derivatives that have all of these characteristics. Therefore, without any description of a derivative strain or of all of the characteristics which are required by said strain, the specification lacks written description of the strains encompassed by the claims.
Applicant argues: That the requirements for biological deposits have been met.
Applicant’s arguments have been fully considered and are not persuasive for the following reasons:
The deposited strain meets the written description requirements. However, the claims are not limited to this strain. Instead, they include derivative strains that have all of the identifying characteristics of the strain. As stated above, there is no description of a derivative strain or of all of the characteristics which are required by said strain. Applicant’s arguments do not address this.
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 20-22, 52-53, and newly submitted claims 57-58 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 pre-AIA the applicant regards as the invention for the reasons set forth in the previous office action.
The claims require B subtilis strain PS-216 or a “derivative thereof having all of the identifying characteristics of B. subtilis PS-216”. If a strain has all of the identifying characteristics of B. subtilis PS-216, it is not clear how the strain would be a derivative of the strain and not just be B. subtilis PS-216.
Applicant argues: That B. subtilis derivatives can be identified by high-resolution genotyping and specific phenotypic markers found in PS-216, including those useful properties set out in the Examples of the present application. Applicant argues that the skilled person would understand that a derivative of PS-216 typically includes bacteria almost being identical to PS-216 yet still having a single difference or small differences that do not matter for its identifying characteristics and thus the utility in the present invention. Such differences can be, for example, a point mutation that does not alter the properties of PS-216 or even small deletions of DNA not playing any role in the functioning of PS-216 as described in the examples and as identified from the characteristics of the strain deposited at the aforementioned IDA. The skilled person having B. subtilis PS-216 available for comparison, is believed to have the ability to determine if a given B. subtilis strain is a derivative of PS-216.
Applicant’s arguments have been fully considered and are not persuasive for the following reasons:
The issue here is where the line is drawn to limit the invention. The claim requires the derivative to have “all of the identifying characteristics of B. subtilis PS-216. There is nothing in the specification defining or limiting what the identifying characteristics are. Small differences can be detected and are thus identifying characteristics. Therefore, a point mutation or deletion of DNA not playing a role in the functioning of PS-216 is still a change in identifying characteristics.
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 20-22, 52-53, and newly submitted claims 57-58 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krapez (Masters Thesis; IDS filed 8/23/2023) for the reasons set forth in the previous office action.
The instant claims are drawn to food and probiotic compositions comprising B subtilis PS216 and either a food ingredient or a pharmaceutical or agricultural excipient.
Krapez discloses the use of probiotic compositions containing B subtilis to be fed to chickens to improve gut health (see abstract). Krapez also discloses compositions comprising B subtilis PS216 and Mueller Hinton Broth (see page 18). Mueller Hinton broth contains beef infusion, starch, and casein hydrolysate, which is a food ingredient and serves as an agriculturally acceptable excipient. Krapez discloses a culture of B subtilis PS216 in Mueller Hinton broth growing at 8 log CFU/ml (see Appendix B8). The growth shows that the Bacillus is in the form of vegetative cells and, at 8 log CFU/ml, this would be above 1000 CFU/kg of the composition.
Applicant argues:
1. That Krapez discloses laboratory cultivation of B. subtilis PS-216 in co-culture with Campylobacter sp. Furthermore, a co-culture of a B. subtilis and Camplyobacter sp. cannot be considered an edible composition since Camplyobacter is a known pathogen and thus the composition would be entirely unsuitable for the intended purpose.
2. That there is no disclosure in the document of a food or a probiotic composition comprising at least 1 x103 cfu of B. subtilis PS-216 per kilogram of composition.
Applicant’s arguments have been fully considered and are not persuasive for the following reasons:
Regarding argument 1, Krapez discloses a monoculture comprising B subtilis PS216 and Mueller Hinton Broth (see page 18 and Appendix B8). As discussed above, Mueller Hinton broth contains beef infusion, starch, and casein hydrolysate, which is a food ingredient and serves as an agriculturally acceptable excipient. As a monoculture, no Campylobacter would be present.
Regarding argument 2, Krapez discloses a culture of B subtilis PS216 in Mueller Hinton broth growing at 8 log CFU/ml (see Appendix B8).
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
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/BRIAN GANGLE/ Primary Examiner, Art Unit 1645
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