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 .
Claim Status
Claims 1-6 are pending.
Claims 1-6 are examined on the merits.
Claim Objections
Claim 1 is objected to because of the following informality: “has been deposited the China General ….” should be “has been deposited in the China General ….”, and “and a deposit of CGMCC No. 40583” should be “and has a deposit number of CGMCC No. 40583”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 2 is 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.
Claim 2 merely recited a “use” of the endophytic fungus of Dendrobium nobile “ in improvement of a yield and quality of Dendrobium nobile” without setting forth active, positive method steps defining how the use is practice. Therefore, it is unclear what acts are required to practice the claimed “use”, and the metes and bounds of claim 2 are unclear. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
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 1-3 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, namely a product of nature/natural phenomenon, without reciting additional elements that amount to significantly more than the judicial exception.
Claim 1 recites an “endophytic fungus of Dendrobium nobile” identified as Phyllosticta fallopiae DNL 19 and deposited as CGMCC No. 40583. The claim is directed to a composition of matter and therefore falls within a statutory category. (Step 1)
Claim 1 is directed to a judicial exception, namely a product of nature. The specification describes the claimed fungus as an endophytic fungus obtained by separating and purifying it from leaves of naturally occurring Dendrobium nobile. Thus, the claimed fungus is a naturally occurring organism isolated from its natural plant host.
The claim does not recites any genetic modification, artificial alteration, mutation, recombinant feature, or other structural change that would distinguish the claimed fungus from the naturally occurring fungus. Merely identifying, isolating, purifying, and depositing the naturally occurring fungus does not establish that the fungus has markedly different characteristics from its natural counterpart. Therefore, the claimed Phyllosticta fallopiae DNL19 fungus is directed to a product of nature. (Step 2A)
Even when considered as a whole, claim 1 does not recite additional elements that amount to significantly more than the judicial exception. The claim is directed solely to the isolated naturally occurring fungus and does not recite any genetic modification, artificial alteration, or other meaningful limitation that transforms the product of nature into patent-eligible subject matter. Accordingly, claim 1 does not amount to significantly more than the product of nature exception and is not patent eligible under 35 U.S.C. 101 . (Step 2B)
Claims 2 depends from claim 1 and merely recite use of the same naturally occurring fungus. However, claim 2 does not recite any active method step, treatment step, genetic modification, artificial alteration, or other additional element that transforms the product of nature into patent-eligible subject matter. Accordingly, claims 1-2, as a whole, do not amount to significantly more than the product of nature and are rejected under 35 U. S. C. 101.
Claim 3 is rejected under 35 U. S. C. 101. Claim 3 recites a use of the endophytic fungus of Dendrobium nobile, wherein the use is “inoculating an endophytic fungus cake into a Dendrobium nobile growth medium for co-culture”. The claim is treated as being directed to a process and therefore falls within a statutory category. (Step 1)
Claim 3 is directed to a judicial exception, namely a product of nature and its natural biological relationship with a host plant. Claim 3 requires use of the endophytic fungus of claim 1, which is identified as Phyllosticta fallopiae DNL19 and deposited as CGMCC No.40583. The specification describes the fungus as being obtained by separating and purifying it from leaves of Dendrobium nobile (Abstract). The specification also explains that endophytic fungi naturally live in tissues and organs of healthy plants and that cross talk between endophytic fungi and their host plants promotes plant growth and secondary metabolism (pa0006).
Thus, the claimed use relies on the naturally occurring fungus and its naturally occurring plant-association function. The claim does not recite any genetic modification, artificial alteration, nutation, or other markedly different characteristic of the fungus relative to the naturally occurring organism. (Step 2A)
Claim 3 does not include additional elements that amount to significantly more than the product of natural and its natural use. The additional limitation of inoculating an endophytic fungus cake into a Dendrobium nobile growth medium for co-culture merely applies routine inoculation/co-culture techniques to the naturally occurring fungus and its natural host plant relationship. This limitation does not change the natural fungus itself or impart markedly different characteristics to the fungus. (Step 2B)
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.
Enablement regarding Biological Deposit
Claims 1-6 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.
Claim 1 is directed to a specific biological material, namely the endophytic fungus Phyllosticta fallopiae DNL 19, deposited as CGMCC No. 40583. Because the claimed invention requires the specific strain, the strain must be obtainable by a repeatable methods set forth in the specification or otherwise be readily available to the public. See 37 CFR 1.802. The specification identifies the strain as being isolated from leaves of Dendrobium nobile, but does not provide a repeatable process that would enable one skilled in the art to obtain the exact same strain in each occurrence from natural plant material. The specification relies on the deposited biological material; however, the record does not establish that the deposit is acceptable and available to the public in accordance with 37 CFR 1.801-1.809. Accordingly, absent evidence that the deposit complies with biological deposit requirements, the specification does not enable one skilled in the art to make and use the claimed strain without undue experimentation.
Claims 2-6 are included in this rejection because they depend directly or indirectly from claim 1 and each requires the same specific deposited biological material, Phyllosticta fallopiae DNL19 (CGMCC No. 40583), to practice the claimed invention.
Applicant may overcome this rejection by providing evidence or a statement establishing that the deposit of Phyllosticta fallopiae DNL19, CGMCC No. 40583, complies with the applicable biological deposit requirements and will be available to the public upon issuance of a patent.
Conclusion
No claims are allowed.
The closest prior art of record, Chen (Jishuang Chen et. al., CN113025498A, Application of 2021-02-05, Publication of 2021-06-25), is directed to a method for co-culturing an endophyte and Dendrobium nobile protocorms to obtain stable and increased dendrobine production. Although this reference is in the same general field of endophyte-mediated promotion of Dendrobium nobile growth and secondary metabolism, it does not teach or disclose the presently claimed deposited strain Phyllosticta fallopiae DNL19 (CGMCC No.40583) recited in claim 1. Nor does the reference teach or reasonably suggest substituting its disclosed endophyte with the presently claimed DNL19 strain with a reasonable expectation of obtaining the claimed yield and quality improvement. Therefore, the closest prior art does not anticipate the claimed invention under 35 U. S. C. 102 or render the claimed invention obvious under 35 U. S. C. 103.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YANXIN SHEN whose telephone number is (571)272-7538. The examiner can normally be reached Monday-Friday.
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/YANXIN NMN SHEN/Examiner, Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663
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