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 .
DETAILED ACTION
1. Claims 1-17 are pending and are examined in the instant application.
Duty of Disclosure
2. Applicant is reminded of their “Duty of Disclosure, Candor, and Good Faith” (see 37 C.F.R. § 1.56 and MPEP § 2001). Information that would be considered pertinent to patentability includes: 1) any progeny or sibling of the claimed strain in another patent-type document or in a publication; 2) all other names for the claimed strain and its parents; and 3) the public availability of the parents and the claimed strain. This information can be submitted in an Information Disclosure Statement with a notation of the relevancy to the instant application.
Claim Objections
3. Claims 1-17 are objected to because of the following:
Scientific name “Agaricus bisporus” should be italicized in all applicable claims.
In claims 3 and 4, it is suggested “derived” be amended to “obtained”.
Dependent claims are included.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
4. 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.
5. Claims 8 and 14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature. The claims do not fall within at least one of the four categories of patent eligible subject matter for the following reasons.
With regard to claim 8, there is no description of the “processed mushrooms”. It is unclear to what extent the mushrooms are processed, and how said processed mushrooms are distinguishable from prior art processed mushrooms. Is the entire genome of strain B19414 present in the processed mushrooms? The Office interprets the mushroom culture of claim 1 to be a live culture. Do the “processed mushrooms” contain a live culture of claim 1?
With regard to claim 14, there is no description of the mushrooms obtained from the mushroom culture of claim 1. What generation of the mushroom culture of claim 1 is Applicant referring to?
Clarification and/or correction is required.
Claim Rejections - 35 USC § 112(b)
6. 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.
7. Claims 2, 3, 8 and 9 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.
In claim 2, it is unclear what alleles at what positions in the recited marker loci having what sequence structure of which chromosome copy is present in the deposited culture. The specification is unclear in addressing this issue. Is strain B19414 in the deposit made up of genetically different sub-strains? If so, it is unclear how the deposit is representative of strain B19414. Absent this information, strain B19414 cannot be distinguished from other strains.
In claim 3, it is unclear which culture “its genome” refers to. It is suggested the claim be amended to read “all of the genome or genotype of the culture”.
In claim 8, “including” is open language. It is unclear what undisclosed embodiments are present in the colonized substrates. It is suggested “including grain, compost, and friable particulate matter” be amended to “are grain, compost, or friable particulate matter” or a Markush grouping.
In claim 9, the recitation of Table 1 is not permitted. See MPEP 2173.05(s), which states:
“Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation be reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).”
There is no evidence that the information from Table 1 cannot be reproduced in claim 9. It is suggested the recitation of “of Table 1” be deleted.
Clarification and/or correction is required.
Claim Rejections - 35 USC § 112(d)
8. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection I, 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.
9. Claim 4 is 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 4 depends from claim 1. Claim 1 requires 100% of the genome of strain B19414. Claim 4 only requires 75% of the genome of strain B19414. Claim 4 is broader than the claim it depends from.
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.
Claim Rejections - 35 USC § 112(a)
10. 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.
11. Claims 1-17 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.
Since the claimed culture is essential to the claimed invention, it must be obtainable by a reproducible method set forth in the specification or otherwise be readily available to the public. If a culture is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. The specification does not disclose a reproducible process to obtain the exact same culture in each occurrence and it is not apparent if such a culture is readily available to the public. If the deposit of the culture is made under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating the culture has been deposited under the Budapest Treaty and that the culture will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent would satisfy the deposit requirement made herein. Availability of the required minimum propagules of the culture must be maintained throughout the period of the deposit.
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 CFR 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 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) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become unviable.
Even though Applicant has indicated Applicant intends to comply with all requirements set forth under 37 CFR 1.801-1.809, there is no evidence of accepted deposits for strain B19414, line B12998-s181 and line P2-s203. Evidence of accepted deposits is requested.
12. Claims 2, 4, 7, 9-14, 16 and 17 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 2 lacks adequate written description because there is no set combination of polymorphisms for the alleles at the recited marker loci, and there is no disclosure of other alleles at other marker loci. It is unpredictable what genotypic and phenotypic characteristics are present in a culture having the alleles at the six recited marker loci. For marker p1n150-G3-2, the specification discloses alleles 2 and 5 ([0169], [0170]). For marker ITS, the specification discloses alleles I1 and I2 ([0175], [0176]). Polymorphic alleles are also disclosed for the other four markers. However, it is not known what combination of polymorphisms of the alleles for these six markers are present in strain B19414. Accordingly, the combination of polymorphisms of the alleles at the six marker loci as found in strain B19414, polymorphisms of alleles of other marker loci, and the genotypic and phenotypic characteristics of a culture having the alleles at the six marker loci lack adequate written description.
Claim 4 lacks adequate written description for the following reasons. Strain B19414 is a heterokaryon, whereby its two haploid genomes are genetically distinct from each other. Before a dikaryotic cell of strain B19414 is crossed with a cell of a genetically distinct strain, its two haploid nuclei merge into a diploid nucleus which undergoes meiosis to form haploid basidiospores. The spores from different strains germinate into primary mycelia and fuse to form a secondary dikaryotic cell having two haploid nuclei. In a heterokaryon, it is unpredictable what reassortment of genes between the two haploid genomes occur to produce haploid basidiospores. The secondary dikaryotic cell is then backcrossed to strain B19414 to produce a culture having 75% of the genome of strain B19414. However, due to the first reassortment of genes from meiosis after the fusing of the two nuclei in a heterokaryon cell of strain B19414, the outcrossing with a genetically different strain, the second reassortment of genes from meiosis in the heterokaryon cell of strain B19414, and the backcrossing of the secondary dikaryotic cell to a heterokaryon cell of strain B19414, it is highly unpredictable what combination of genes are present in said culture having 75% of the genome of strain B19414 and the phenotypic characteristics of said progeny culture. Accordingly, a culture having 75% of the genome of strain B19414 lacks adequate written description.
Claims 7, 10-14, 16 and 17 lack adequate written description for the following reasons. The reproductive process of A. bisporus has been summarized above. Spores, spore cells and cells formed upon the basidial cell of heterokaryon strain B19414 are generated by fusing two genetically different nuclei prior to meiosis to produce haploid spores or basidial cells. It is unpredictable what reassortment of genes occur at meiosis. Applicant does not disclose a representative number of spores or basidial cells of strain B19414 to allow one skilled in the art to predict their genotypes. Accordingly, spores, spore cells, basidial cells, lines obtained or incorporated from a part of the mushroom culture wherein the part is a meiosis product, heterokaryons and homokaryons obtained from a culture of strain B19414 by any means, and mushrooms obtained from the mushroom culture of strain B19414 by any means and of any generation, are not adequately described.
For the above reasons, there is a lack of adequate description to inform a skilled artisan that Applicant was in possession of the claimed invention at the time of filing. See https://www.uspto.gov/sites/default/files/web/menu/written.pdf.
Claim Rejections - 35 USC §§ 102 and 103
13. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
14. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
15. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
16. Claim 8 and 14 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Kerrigan et al. (U.S. Pat. No. 9622428 (A)).
As stated in the 35 USC 101 and 112(a) rejections above, the claimed processed mushrooms and the mushrooms obtained from the mushroom culture of claim 1 are not adequately described. These claimed mushrooms are not distinguishable from the prior art. The claimed mushrooms are not required to retain any of the genotypic or phenotypic characteristic of strain B19414.
The prior art teaches hybrid mushroom strain J11500 which is indistinguishable from the claimed processed mushrooms and mushrooms obtained from any generation of the mushroom culture of strain B19414.
Accordingly, the claimed invention is anticipated by, or in the alternative, is obvious in view of the prior art. Since the Patent Office does not have the facilities to examine and compare Applicant’s mushrooms with those of the prior art, the burden of proof is upon the Applicant to show an unobvious distinction between them. See In re Best, 562F.2d 1252, 195 USPQ 430 (CCPA 1977).
Conclusion
17. No claim is allowed.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG T BUI whose telephone number is (571)272-0793. The examiner can normally be reached on M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on 571-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHUONG T BUI/Primary Examiner, Art Unit 1663
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