The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The amendment filed on 8-26-2025 is acknowledged. Claims 4 and 7-8 have been amended.
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 8-26-2025 is acknowledged. The traversal is on the ground(s) that the special technical feature shared by the product and method is the unexpected silica-dependent proliferation in a high-vegetable-oil matrix which makes a contribution over the art and that the Colenutt et al. reference does not negate the aforementioned special technical feature. This is not found persuasive because the “silica-dependent proliferation in a high-vegetable-oil matrix” is not a limitation of the claims. The claims merely require that a composition comprise vegetable oil and/or fat substance, silica and one of the recited strains of Bacillus subtilis. As evidenced by the rejections set forth below such a combination does not make a contribution to the art and therefore there is no unity of invention. With regard to the species election of a particular strain of Bacillus subtilis, Applicant’s arguments have been fully considered and deemed persuasive. Hence, the requirement for said species election is withdrawn. Consequently, all the recited strains of Bacillus subtilis are deemed to be functional (obvious) equivalents.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-19 are pending. Claims 7-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1-6 and 9-19 are currently under examination.
Information Disclosure Statement
The Information Disclosure Statement filed on 3-6-2023 has been considered. An initialed is attached hereto.
It should be noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d), a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 1-6 and 9-19 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 enablement requirement. The claim(s) contains 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 Bacillus subtilis strains LA13030, CU1, HU58, DE 111, DSM 15544, PXN 21, Rosell-179 and/or DSM 33619 are required in order to practice the invention. Specifically, it is noted that claim 1 recites deposited material and that claims 2-6 and 9-19 are depend from the claim reciting deposited material The deposit of biological organisms is considered by the Examiner to be necessary for the enablement of the current invention (see 37 CRF 1.808(a)).
If the deposit is made under terms of the Budapest Treaty, then an affidavit or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirements. See 37 CFR 1.808.
If a deposit is not made under the terms of the Budapest Treaty, then an affidavit, or declaration by Applicants or person(s) associated with the patent owner (assignee) who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the following criteria have been met:
1) during the pendency of the application, access to the deposit will be afforded to one determined by the Commissioner to be entitled thereto;
2) all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent; and
3) the deposits will be maintained for a term of at least thirty (30) years from the date of the deposit or for the enforceable life of the patent or for a period of at least five (5) years after the most recent request for the furnishing of a sample of the deposited material, whichever is longest; and
4) a viability statement in accordance with the provisions of 37 CFR 1.807; and
5) the deposit will be replaced should it become necessary due to inviability, contamination or loss of capability to function in the manner described in the specification.
In addition, the identifying information set forth in 37 CRF 1.809(d) should be added to the specification. See 37 CFR 1.803 – 1.809 for additional explanation of these requirements.
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 1-6 and 9-19 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 1 is rendered vague and indefinite by the use of the term “fat substance”. It is unclear what is meant to be engendered by said phrase as it is not specifically defined in the specification nor does it constitute an art recognized term. As written, it is impossible to determine the metes and bounds of the claimed invention.
Claim 1 is rendered vague and indefinite by the use of the terms “LA13030, CU1, HU58,
DE 111, DSM 15544, PXN 21, Rosell-179 and/or DSM 33619”. It is unclear whether said terms constitute laboratory designations or accession numbers.
Claim 2 is rendered vague and indefinite by the use of the term “fat substance”. It is unclear what is meant to be engendered by said phrase as it is not specifically defined in the specification nor does it constitute an art recognized term. As written, it is impossible to determine the metes and bounds of the claimed invention.
Claim 3 recites the limitation "silicic acid" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation "silicic acid" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 is rendered vague and indefinite by the use of the term “fat substance”. It is unclear what is meant to be engendered by said phrase as it is not specifically defined in the specification nor does it constitute an art recognized term. As written, it is impossible to determine the metes and bounds of the claimed invention.
Claim 13 is rendered vague and indefinite by the use of the term “fat substance”. It is unclear what is meant to be engendered by said phrase as it is not specifically defined in the specification nor does it constitute an art recognized term. As written, it is impossible to determine the metes and bounds of the claimed invention.
Claim 14 is rendered vague and indefinite by the use of the term “fat substance”. It is unclear what is meant to be engendered by said phrase as it is not specifically defined in the specification nor does it constitute an art recognized term. As written, it is impossible to determine the metes and bounds of the claimed invention.
Claim 15 is rendered vague and indefinite by the use of the term “fat substance”. It is unclear what is meant to be engendered by said phrase as it is not specifically defined in the specification nor does it constitute an art recognized term. As written, it is impossible to determine the metes and bounds of the claimed invention.
Regarding claim 16, the phrase "comprising preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 16 recites the limitation "silicic acid" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 17, the phrase "comprising preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 17 recites the limitation "silicic acid" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 18, the phrase "comprising preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 18 recites the limitation "silicic acid" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 18, the phrase "comprising preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 18 recites the limitation "silicic acid" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-3, 5-6 and 9-15 are rejected under 35 U.S.C. 102(a) as being anticipated by Kanagalingam et al. (U.S. Patent Application Publication US 2020/0131096).
Kanagalingam et al. disclose compositions comprising bacteria (see abstract). Kanagalingam et al. further disclose: that the bacteria can be Bacillus subtilis generally (see paragraph [0026]) or Bacillus subtilis strain DSM 15544 (see paragraph [0034]; that their compositions can contain a weight fraction of olive oil up 98% (see paragraph [0099]) and silica (see paragraph [0118]) and that their product can be a food product (see paragraph [0108] or a pharmaceutical composition (see paragraph [0110]). Consequently, Kanagalingam et al. anticipates all the limitations of the rejected claims.
Claims 1-3, 5-6 and 9-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wood et al. (WO 2019/178309).
Wood et al. disclose probiotic compositions comprising bacteria (see abstract). Wood et al. further disclose: that the bacteria can be Bacillus subtilis generally (see paragraph [0025]) or Bacillus subtilis strain DSM 15544 (see paragraph [0026]; that their compositions can contain a weight fraction of olive oil up 98% (see paragraph [0036]) and silica (see paragraph [0054]) and that their product can be a food product (see paragraph [0043] or a pharmaceutical composition (see paragraph [0046]). Consequently, Wood et al. anticipates all the limitations of the rejected claims.
Claims 1-3, 5-6 and 9-15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wood et al. (WO 2019/178309).
Wood et al. disclose probiotic compositions comprising bacteria (see abstract). Wood et al. further disclose: that the bacteria can be Bacillus subtilis generally (see paragraph [0025]) or Bacillus subtilis strain DSM 15544 (see paragraph [0026]; that their compositions can contain a weight fraction of olive oil up 98% (see paragraph [0036]) and silica (see paragraph [0054]) and that their product can be a food product (see paragraph [0043] or a pharmaceutical composition (see paragraph [0046]). Consequently, Wood et al. anticipates all the limitations of the rejected claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6 and 9-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kanagalingam et al. (U.S. Patent Application Publication US 2020/0131096).
Kanagalingam et al. disclose compositions comprising bacteria (see abstract). Kanagalingam et al. further disclose: that the bacteria can be Bacillus subtilis generally (see paragraph [0026]) or Bacillus subtilis strain DSM 15544 (see paragraph [0034]; that their compositions can contain a weight fraction of olive oil up 98% (see paragraph [0099]) and silica (see paragraph [0118]) and that their product can be a food product (see paragraph [0108] or a pharmaceutical composition (see paragraph [0110]).
Kanagalingam et al. differ from the rejected claims in that they don’t explicitly disclose the use of silicic acid as the silica.
However, the KSR decision sets forth “if a technique has been used to improve one device, and a person of skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill”. Given that Kanagalingam et al. demonstrates the use of silicas in their compositions and the various types of silica derivatives are well established in the art, the use of silicic acid in the compositions of Kanagalingam et al. is well within the capabilities of one of ordinary skill in the art. Hence, the requirements of obviousness under the KSR decision are met.
Moreover, with regard to the specific concentrations of silicic acid in claims 16-19, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235(CCPA 1955).
Claims 1-6 and 9-19 are rejected under 35 U.S.C. 103 as being unpatentable over Wood et al. (WO 2019/178309).
Wood et al. disclose probiotic compositions comprising bacteria (see abstract). Wood et al. further disclose: that the bacteria can be Bacillus subtilis generally (see paragraph [0025]) or Bacillus subtilis strain DSM 15544 (see paragraph [0026]; that their compositions can contain a weight fraction of olive oil up 98% (see paragraph [0036]) and silica (see paragraph [0054]) and that their product can be a food product (see paragraph [0043] or a pharmaceutical composition (see paragraph [0046]).
Wood et al. differ from the rejected claims in that they don’t explicitly disclose the use of silicic acid as the silica.
However, the KSR decision sets forth “if a technique has been used to improve one device, and a person of skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill”. Given that Wood et al. demonstrates the use of silicas in their compositions and the various types of silica derivatives are well established in the art, the use of silicic acid in the compositions of Wood et al. is well within the capabilities of one of ordinary skill in the art. Hence, the requirements of obviousness under the KSR decision are met.
Moreover, with regard to the specific concentrations of silicic acid in claims 16-19, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235(CCPA 1955).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT A ZEMAN whose telephone number is (571)272-0866. The examiner can normally be reached Monday thru Friday; 6:30 am - 3pm EST.
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 571-272-00857. 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.
/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 December 11, 2025