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
Election was made of Group III, claims 3-6, without traverse in the reply filed on 11/21/25. Elected group III is drawn to a hemostatic material comprising the compound of claim 2 (original group II). As such, the examiner has withdrawn the restriction requirement set forth between groups II and III and will examine claims 2-6 herein in their entirety.
Claim 1 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 2 and 3 are objected to because of the following informalities: the structures set forth are blurry and are missing a H atom on the O as indicated below. Appropriate correction is required.
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Claims 2 and 3 are objected to because of the following informalities: it is unclear if the C-atom linkage as indicated below is present or the O is linked directly to the sugar. The examiner believes this is intended to be a C-atom wherein the hetero-rings are linked via -C-O-C- groups.
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Specification
The disclosure is objected to because of the following informalities: as noted above, the structure of the compound should be presented in clearer form; contain the required H atom; and also make clear the C-atom linkage is present.
Appropriate correction is required.
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 2-6 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 2-6 are drawn to an exopolysaccharide produced by a bacillus sp. 1229 and hemostatic material comprising the same. It is apparent that this bacillus sp. 1229 is required to practice the claimed invention. As such the biological material must be known and readily available or obtainable by a repeatable method set forth in the specification, or otherwise known and readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the biological material.
The process disclosed in the specification does not appear to be repeatable, it is not clear that the invention will work with commonly available material and it is not apparent if the biological materials considered necessary to make and use the invention is both known and readily available to the public.
The fact that these compounds are produced by this bacillus, and have not been shown to be produced by any other means, a person skilled in the art could not make or use the invention defined in and commensurate with the claims without access to the specific biological material.
It is noted applicants stated in [0008] of their specification that a deposit has been made is the China Center for Type Culture Collection as deposit number CCTCC NO: M 2022553, but the evidence is incomplete and it is noted that there is no indication in the specification as to public availability. Therefore, a deposit at a recognized depository may be made to obviate this rejection.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, 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 the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration by Applicant or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing 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; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
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.
Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring product without significantly more. The claim(s) recite(s) an exopolysaccharide produced by Paenibacillus sp. 1229 have a specified formula which is not markedly different than the naturally occurring product as it occurs in nature. This judicial exception is not integrated into a practical application because the species from which this is produced does not add meaningful limitations to the compound claimed itself. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations only state where the product is from and do not impart limitations on the structure of the compound claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 10,738,275 – which is drawn to Paenibacillus sp. strain having deposit number CGMCC No. 8333 and methods of culturing exopolysaccharides with the same wherein the exopolysaccharides have the formula:
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which are different and do not anticipate or render obvious those claimed herein nor the hemostatic material comprising the same.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRAVISS C MCINTOSH III whose telephone number is (571)272-0657. The examiner can normally be reached Monday-Friday 9AM-5:30PM 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, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TRAVISS C. MCINTOSH III
Primary Examiner
Art Unit 1693
/TRAVISS C MCINTOSH III/ Primary Examiner, Art Unit 1693