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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The use of the term Sabouraud (PGPUB [0049]), Qingdao Hi-Tech Industrial Park Hope Bio-Technology Co (PGPUB [0049 and 0055]), BLAST ([0062 and 0069]). which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 1-14 are rejected under 35 U.S.C. 112, 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.
The invention appears to employ novel biological materials, Aspergillus flavus EXY1A109 with a deposit number of CCTCC No:M20021465. Since the biological materials are essential to the claimed invention, they must be obtainable by a reproducible method set forth in the specification or otherwise readily available to the public. Instant specification example 2 discloses that the strain was isolated from a peanut producing area of Xianyang, this area of the world is not readily accessible to the public in the United States. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
From the specification it is not apparent if the biological materials are readily available to the public. It is noted that Applicant has deposited Aspergillus flavus EXY1A109 with a deposit number of CCTCC No:M20021465 but there is no indication in the specification as to public availability. If the deposit is made under the Budapest Treaty, then an affidavit or declaration by applicant or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature and registration number, 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 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 C.F.R. §§ 1.801-1.809, Applicant may provide assurance of compliance by an 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 this 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 effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made (see 37 C.F.R. § 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant’s attention is directed to M.P.E.P. §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that “the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination.” The specification should be amended to include this information, however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
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.
Claims 1-2 and 7-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
The claims recite Aspergillus flavus EXY1A109 with a deposit number of CCTCC No:M20021465. This judicial exception is not integrated into a practical application because the claims 1-2 are directed to the natural product itself. The preparation of claims 7-12 require nothing beyond the natural product. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because instant specification examples 1 and 2 indicate that the claimed A. flavus is a natural product that comprises a unique gene (SEQ ID NO:1). Example 2 indicates that the unique gene was isolated from the genomic DNA of the microorganism, and therefore the claimed unique gene is a natural product as well.
Step 1: This part of the eligibility analysis evaluates whether the claim falls within any
statutory category. MPEP 2106.03. The claims recite Aspergillus flavus EXY1A109 with a deposit number of CCTCC No:M20021465 and a preparation requiring the natural product of claim 1. Thus, the claims are to a product of nature, which is one of the statutory categories of invention. (Step 1: YES).
Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim
recites a judicial exception. As explained in MPEP 2106.04(II) and the October 2019 update, a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim. Claims 1-2 require a naturally isolated Aspergillus flavus. In addition, the limitation of the preparation in claims 7-12 do not require any specific steps beyond what occurs naturally in nature and therefore the preparation is not structurally limiting or beyond the natural product. Accordingly, limitation of Aspergillus flavus EXY1A109 with a deposit number of CCTCC No:M20021465, recites a judicial exception (natural product). Accordingly, the claim recites a judicial exception, and the analysis must therefore proceed to Step 2A Prong Two.
Step 2A Prong Two: This part of the eligibility analysis evaluates whether the claim as a
whole integrates the recited judicial exception into a practical application of the
exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating
those additional elements individually and in combination to determine whether the
claim as a whole integrates the exception into a practical application. 2019 PEG Section
III(A)(2), 84 Fed. Reg. at 54-55. The claimed preparation does not require any additional elements that render the claimed preparation markedly different from the natural counterpart. The claimed preparation requires nothing more than Aspergillus flavus EXY1A109 with a deposit number of CCTCC No:M20021465, a naturally occurring microbe. Accordingly, the limitations laid out in claims 1-2 and 7-12 do not integrate the recited judicial exception into a practical application and the claims 1-2 and 7-12 are therefore directed to the judicial exception. See MPEP 2106.05(h), discussing the administration step in Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 78 (2012) (Step 2A: YES).
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole
amounts to significantly more than the recited exception, i.e., whether any additional
element, or combination of additional elements, adds an inventive concept to the claim.
MPEP 2106.05. As discussed with Step 2A prong 2, the addition of the intended use in claims 7-12 of a preparation is at best the equivalent of merely adding the words “apply it” as the
claimed process does not require any additional elements that are sufficient to amount to
significantly more than the judicial exception. Mere instructions to apply an exception cannot
provide an inventive concept (Step 2B: NO).
Claims 1-2 and 7-12 are not eligible.
Claims 3-6 and 13-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The claims require methods requiring Aspergillus flavus EXY1A109 with a deposit number of CCTCC No:M20021465. The methods of claims 3-6 and 13-14 require nothing beyond the growth of the microorganism, a process that occurs in nature. The co-culture inhibition aflatoxin production of claim 13-14 would likewise take place in the natural environment. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because instant specification examples 1 and 2 indicate that the claimed A. flavus is a natural product that comprises a unique gene (SEQ ID NO:1). Example 2 indicates that the unique gene was isolated from the genomic DNA of the microorganism, and therefore the claimed unique gene is a natural product as well.
Step 1: This part of the eligibility analysis evaluates whether the claim falls within any
statutory category. MPEP 2106.03. The claims require methods involving the natural product of claim 1. Thus, the claims are to a natural process, which is one of the statutory categories of invention. (Step 1: YES).
Step 2A Prong One: This part of the eligibility analysis evaluates whether the claim
recites a judicial exception. As explained in MPEP 2106.04(II) and the October 2019 update, a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim. For a process claim, the general rule is that the claim is not subject to the markedly different analysis for nature-based products used in the process. MPEP 2106.04(c)(I)(C). In addition, the limitation of the methods does not require any specific steps beyond what occurs naturally in nature and therefore the methods are not structurally limiting or beyond the natural process. Accordingly, limitation methods requiring Aspergillus flavus EXY1A109 with a deposit number of CCTCC No:M20021465, recites a judicial exception (natural process). Accordingly, the claims recite a judicial exception, and the analysis must therefore proceed to Step 2A Prong
Two.
Step 2A Prong Two: This part of the eligibility analysis evaluates whether the claim as a
whole integrates the recited judicial exception into a practical application of the
exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating
those additional elements individually and in combination to determine whether the
claim as a whole integrates the exception into a practical application. 2019 PEG Section
III(A)(2), 84 Fed. Reg. at 54-55. The claimed methods do not require any additional elements that render the claimed process markedly different from the natural process. The claimed method requires nothing more than Aspergillus flavus EXY1A109 with a deposit number of CCTCC No:M20021465 growing in a natural environment. Accordingly, the limitations laid out in claims 3-6 and 13-14 are therefore directed to the judicial exception. See MPEP 2106.05(h), discussing the administration step in Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 78 (2012) (Step 2A: YES).
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole
amounts to significantly more than the recited exception, i.e., whether any additional
element, or combination of additional elements, adds an inventive concept to the claim.
MPEP 2106.05. As discussed with Step 2A prong 2, the addition of the intended use in claims 3-6 and 13-14 of a process is at best the equivalent of merely adding the words “apply it” as the
claimed process does not require any additional elements that are sufficient to amount to
significantly more than the judicial exception. Mere instructions to apply an exception cannot
provide an inventive concept (Step 2B: NO).
Claims 3-6 and 13-14 are not eligible.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TREVOR KANE/
Examiner, Art Unit 1657
/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
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