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 .
The amendment filed 05/11/2026 has been entered. Claims 2-4 and 12-14 are cancelled. Claims 1, 5-11 and 15-20 have been amended. Claims 21-30 are new. Claims 1, 5-11 and 15-30 are pending and under examination.
The objection to the specification is withdrawn in view of the amendment t filed 05/11/2026.
The objection to claim 4 is withdrawn in view of the cancellation of the claim.
The rejection of claims 1, 3-11 and 13-20 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of the amendment to the claims.
The rejection of claims 1-20 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph is withdrawn in view of the amendment to the claims.
The rejection of claims 2-3 and 12-13 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35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn in view of the cancellation of the claims.
The rejection of claims 3-10 and 13-20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the amendment to the claims.
The rejection of claims 11-20 under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more is withdrawn in view of the amendment to the claims.
The rejection of claims 1, 4-11 and 14-20 under 35 U.S.C. 102(a)(a) as being anticipated by Sandy et al. CN 111356464 6-30-2020 cited in IDS is withdrawn in view of the amendment to the claims.
New Claim Rejections Based on Amendment
Claims 1, 5-11 and 15-30 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. This is a biological deposit rejection.
The specification lacks complete deposit information for the deposit of Bifidobacterium animalis subsp. Lactis NexStrain 02. Because it is not clear that the bacteria with the properties of Bifidobacterium animalis subsp. Lactis NexStrain 02 are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the claims requires Bifidobacterium animalis subsp. Lactis NexStrain 02, a suitable deposit for patent purposes is required. Exact replication of the plasmid is an unpredictable event.
Applicant's referral in the specification to the preservation of the bacteria in the General Microbiological Center of the China Microbiological Culture Collection Management Committee on July 27, 2020, with an Accession number of CGMCC No. 20455 is an insufficient assurance that all required deposits have been made and all the conditions of 37 CFR §1.801-1.809 have been met.
If the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of deposit and the complete name and full street address of the depository is required.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR §1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request;
(b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application;
(c) the deposits will be maintained in a public depository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and
(d) the deposits will be replaced if they should become nonviable or non-replicable.
In addition, a deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and during the term of deposit. Viability may be tested by the depository. The test must conclude only that the deposited material is capable of reproduction. A viability statement for each deposit of a biological material not made under the Budapest Treaty must be filed in the application and must contain:
1) The name and address of the depository;
2) The name and address of the depositor;
3) The date of deposit;
4) The identity of the deposit and the accession number given by the depository;
5) The date of the viability test;
6) The procedures used to obtain a sample if the test is not done by the depository; and
7) A statement that the deposit is capable of reproduction.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
Applicant's attention is directed to In re Lundack, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
Reply to Applicants’ Response
Acknowledgment is made of the statement by the attorney of record stating that the specific Bifidobacterium animalis subsp. lactis NexStrain 02, deposit accession number CGMCC No. 20455 has been deposited under the Budapest Treaty and the biological material will be, irrevocably and without restriction or condition, released to the public upon the issuance of the patent and the deposited material will be maintained for a period of 30 years, or 5 years after the most recent request date, whichever is longer.
However, the statement is insufficient to overcome the rejection because the statement does not state that the deposit will be replaced if viable samples cannot be dispensed by the depository.
Claim Rejections - 35 USC § 112
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 and 26-30 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
20 is drawn to the pharmaceutical composition according to claim 11, wherein the probiotic and the PD-1 antibody are used or not used at the same time. The metes and bounds of how the probiotic and the PD-1 antibody are not used at the same time is not clear. This is because in claim 11 both the probiotic and the PD-1 antibody are present in the same composition.
Claim 26-28 recite the limitation "the method according to claim 16. There is insufficient antecedent basis for this limitation in the claim because claim 16 is drawn to a pharmaceutical composition.
Claim 29 recites the limitation "the method according to claim 18. There is insufficient antecedent basis for this limitation in the claim because claim 18 is drawn to a pharmaceutical composition.
Claim 30 recites the limitation "the method according to claim 19. There is insufficient antecedent basis for this limitation in the claim because claim 19 is drawn to a pharmaceutical composition.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6, 21-23, 16 and 26-28 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 recites the pharmaceutical composition according to claim 1, wherein the pharmaceutical composition is used for tumor immunotherapy. However, in claim 1, the claim states recites a method of treating a tumor treatment which is tumor immunotherapy. Therefore, claim 6 fails to further limit the subject matter of the claim upon which it depends.
Claim 16 recites the pharmaceutical composition according to claim 11, wherein the pharmaceutical composition is used for tumor immunotherapy. However, claim 11 states that the pharmaceutical composition is used for tumor treatment which is tumor immunotherapy. Therefore, claim 16 fails to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Status of Claims
Claims 1, 5-11 and 15-30 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 OLUWATOSIN A OGUNBIYI whose telephone number is (571)272-9939. The examiner can normally be reached IFP.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645
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