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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-12, 17-27 and 41, in the reply filed on May 13, 2026 is acknowledged.
Claims 13-16 and 28-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claims 5-12 and 23-27 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims 5-12 and 23-27 have not been further treated on the merits.
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 1-4, 17-22 and 41 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.
Claims 1 and 19 recite an isolated Bacillus altitudinis strain ([0012]) deposited under the Accession No. NCIMB 43558 on 27/1/2020. Since the microorganism(s) is/are essential to the claimed invention it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the microorganism(s)is/are not so obtainable or available, the requirements of 35 USC 112 may be satisfied by deposit(s) of the microorganism(s). The specification does not disclose a repeatable process to obtain the microorganism(s) and it is not clear from the specification or record that the microorganism(s) is/are readily available to the public.
This rejection may be overcome by establishing that each microorganism identified is readily available to the public and will continue to be so for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer, or by an acceptable deposit as set forth rein.
If the depository 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/her signature and registration number, stating that the specific strain has been deposited under the Budapest Treaty and that the strain will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
If the 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, applicants may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney over his/her 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 the 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 effective life of the patent, whichever is longer; and,
(d) the deposit will be replaced if it should ever become inviable.
The specification must also state the date of deposit(s), the number(s) granted the deposit(s) by the depository and the name and address of the depository.
Claims 2-4, 17-18, 20-22 and 41 are included as they depend from 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 17-22 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Hashman (US 2016/0037781 A1; Feb. 11, 2016).
Regarding claims 1-2, Hashman discloses an isolated Bacillus altitudinis strain ([0012]) and its use in compositions ([0123]). Hashman fails to disclose the specific strain as claimed, wherein it is deposited under the Accession No. NCIMB 43558 on 27/1/2020, however, it would have been obvious to one of ordinary skill in the art to use any Bacillus altitudinis strain as Hashman teaches that a Bacillus altitudinis is known to be useful in compositions and therefore any Bacillus altitudinis strain would expectedly perform the same absent a showing otherwise.
Regarding claim 3, Hashman teaches that the composition can be a food product ([0123]).
Regarding claim 4, Hashman teaches that the composition further comprises a probiotic material ([0123]).
Regarding claim 17, as stated above with respect to claim 1, Hashman discloses a composition comprising spores from an isolated Bacillus altitudinis strain ([0012], [0123]). Hashman fails to disclose the specific strain as claimed, wherein it is deposited under the Accession No. NCIMB 43558 on 27/1/2020, however, it would have been obvious to one of ordinary skill in the art to use any Bacillus altitudinis strain as Hashman teaches that a Bacillus altitudinis is known to be useful in compositions and therefore any Bacillus altitudinis strain would expectedly perform the same absent a showing otherwise.
With respect to the composition being used for improving the nutritional quality of colostrum, positively modulating the histology parameters of the intestine, and positively modulating the intestinal and/or colostrum microbiome, the examiner notes that such limitations are merely intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, the prior art comprises the same components as claimed, e.g. a composition comprising spores from an isolated Bacillus altitudinis strain ([0012], [0123]), and therefore would expectedly perform the intended use as claimed.
Regarding claim 18, as stated above with respect to claim 1, Hashman discloses a composition comprising spores from an isolated Bacillus altitudinis strain ([0012], [0123]). Hashman fails to disclose the specific strain as claimed, wherein it is deposited under the Accession No. NCIMB 43558 on 27/1/2020, however, it would have been obvious to one of ordinary skill in the art to use any Bacillus altitudinis strain as Hashman teaches that a Bacillus altitudinis is known to be useful in compositions and therefore any Bacillus altitudinis strain would expectedly perform the same absent a showing otherwise.
With respect to the composition being used for positively modulating the immune system of a subject and/or their offspring subjected to the composition, the examiner notes that such limitations are merely intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, the prior art comprises the same components as claimed, e.g. a composition comprising spores from an isolated Bacillus altitudinis strain ([0012], [0123]), and therefore would expectedly perform the intended use as claimed.
Regarding claims 19-20, as stated above with respect to claim 1, Hashman discloses an isolated Bacillus altitudinis strain ([0012]) and its use in compositions ([0123]). Hashman teaches that a cell extract or supernatant can be used (See Examples, [0213], [0219]
Hashman fails to disclose the specific strain as claimed, wherein it is deposited under the Accession No. NCIMB 43558 on 27/1/2020, however, it would have been obvious to one of ordinary skill in the art to use any Bacillus altitudinis strain as Hashman teaches that a Bacillus altitudinis is known to be useful in compositions and therefore any Bacillus altitudinis strain would expectedly perform the same absent a showing otherwise.
Regarding claim 21, Hashman teaches that the composition can be a food product ([0123]).
Regarding claim 22, Hashman teaches that the composition further comprises a probiotic material ([0123]).
Regarding claim 41, as stated above with respect to claim 1, Hashman discloses a composition comprising an isolated Bacillus altitudinis strain, or spores thereof ([0012], [0123]). Hashman fails to disclose the specific strain as claimed, wherein it is deposited under the Accession No. NCIMB 43558 on 27/1/2020, however, it would have been obvious to one of ordinary skill in the art to use any Bacillus altitudinis strain as Hashman teaches that a Bacillus altitudinis is known to be useful in compositions and therefore any Bacillus altitudinis strain would expectedly perform the same absent a showing otherwise.
With respect to the composition being used for increasing adherence of commensal bacteria in the gut, the examiner notes that such limitation is merely intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, the prior art comprises the same components as claimed, e.g. a composition comprising an isolated Bacillus altitudinis strain ([0012], [0123]), and therefore would expectedly perform the recited intended use.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE A KOHLER whose telephone number is (571)270-1075. The examiner can normally be reached Monday-Friday 8am-5pm.
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, Nikki Dees can be reached at (571) 270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEPHANIE A KOHLER/Primary Examiner, Art Unit 1791
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