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 preliminary amendment filed on 6/28/2023 is acknowledged. Claims 1-41 are cancelled. New claims 42-61 are added. Claims 42-61 are pending and are currently under examination.
Information Disclosure Statement
The information disclosure statement filed on 10/24/2023 has been considered. A signed copy is enclosed.
Claim Objections
Claim 52 is objected to because of the following informalities: The claim contains a grammatical error in the phrase “deposited by in the”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claim 52 is 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 bacterial strains DSM 33602, 33603, and 33604 are required to practice the claimed invention. As such they must be readily available or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If not so obtainable or available, the requirements of 35 USC 112, first paragraph, may be satisfied by a deposit of the bacterial strains.
It is noted that Applicants have referred to a deposit of the strains, 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 42-61 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.
Claims 42, 45, 56, and 58 are rendered indefinite by the reference to GenBank accession number NC_012226.1. No specific sequence for this accession number is provided in the instant specification. The use of a GenBank accession number is indefinite because the sequence associated with said number can be changed over time. In fact, the instant accession number has had revisions multiple times since applicant has filed this application. Further, there is nothing preventing the associated sequence from being changed in the future.
Claims 42, 45, 56, and 58 are indefinite because, based on the phrase “or a variant of said gene of any strain of B. hyodysenteriae” it is not clear whether the plasmid pBHWA1 is actually required or whether a B. hyodysenteriae strain with a variant of fucT is all that is required.
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.
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/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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