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 on 9/15/2025 is acknowledged. Claims 1, 3-5, 7-9, 12-14, 16, 19-22, 24, 52-53, and 55 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Claims 1, 3-5, 7-9, 12-14, 16, and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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, 24, 52-53, and 55 are currently under examination.
Information Disclosure Statement
The information disclosure statement filed on 8/23/2023 has been considered. A signed copy is enclosed.
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 20-22, 24, 52-53, and 55 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. 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.
Claim Rejections - 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, 24, 52-53, and 55 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. 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.
Claims 20-22, 24, 52-53, and 55 are rejected 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.
It is apparent that the bacterial strain B subtilis PS216 is required to practice the claimed invention. As such it must be readily available or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112, first paragraph, may be satisfied by a deposit of the bacterial strain.
It is not apparent if the bacterial strain is readily available to the public. It is noted that Applicants have referred to a deposit of the strain, but there is no indication in the specification as to public availability. The mere reference to a deposit or the biological material itself in any document or publication does not necessarily mean that the deposited biological material is readily available. Even a deposit made under the Budapest Treaty and referenced in a United States or foreign patent document would not necessarily meet the test for known and readily available unless the deposit was made under conditions that are consistent with those specified in these rules, including the provision that requires, with one possible exception ( 37 CFR 1.808(b)), that all restrictions on the accessibility be irrevocably removed by the applicant upon the granting of the patent. Ex parte Hildebrand, 15 USPQ2d 1662 (Bd. Pat. App. & Int. 1990).
If a deposit is made under the terms of the Budapest Treaty, then an affidavit or declaration by Applicants, or a statement by an attorney of record over his or her signature and registration number, stating that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. If a deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing that:
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
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, 24, 52-53, and 55 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.
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.
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.
Claims 20-22, 24, 52-53, and 55 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krapez (Masters Thesis; IDS filed 8/23/2023).
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.
Conclusion
No claim is allowed.
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.
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, Vanessa Ford can be reached at 571-272-0857. 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.
/BRIAN GANGLE/Primary Examiner, Art Unit 1645
Prosecution Insights