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
Applicant’s election without traverse of Group V, claims 13 and 14 in the reply filed on 9 February 2026 is acknowledged.
Claims 1-12 and 15-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9 February 2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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 13 and 14 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.
The claims appear to require a specific Agaricus bisporus homokaryotic line, designated J19109-s40, and the instant Specification indicates that a culture of said line was deposited at the NRRL depository on pages 12-13. The Specification further states that the deposit is “intended to meet…all deposit requirements under the Budapest Treaty” on page 12, lines 30-31. What is at issue is that it is unclear if the deposit was made and accepted under the terms of the Budapest Treaty at the NRRL depository. The Application does not contain any deposit receipts and Applicant has not filed an independent viability statement concerning the deposit. The Examiner acknowledges Applicants assurance that the deposit will be irrevocably and without restriction or condition released to the public on page 13, line 3-5.
Hence, given the fact that Agaricus bisporus homokaryotic line J19109-s40 was selected from a heterokaryon of B18287-s82 x WBL-s290 it would have required undue trial and error experimentation to select the same homokaryon from the parental heterokaryon even if the heterokaryon or the parental lines were publicly available.
Claim 14 is 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.
Applicant claims a culture derived from Agaricus bisporus homokaryotic line J19109-s40 or a directly derived from said culture, such that at least 75% of its genome or genotype is present in the genome or genotype of the initial culture of Agaricus bisporus homokaryotic line J19109-s40.
Applicant describes Agaricus bisporus homokaryotic line J19109-s40 predominantly by means of a deposit of biological material and six standard markers in Table II on page 36 of the Specification. The Examiner notes that Agaricus bisporus homokaryotic line J19109-s40 has the same six standard markers as parental line WBL-s290.
Applicant does not describe the broad genus of derived culture(s) such that at least 75% of its genome or genotype is present in the genome or genotype of Agaricus bisporus homokaryotic line J19109-s40.
Hence, it is unclear that Applicant was in possession of the invention as broadly claimed. The decision in AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. 111 USPQ2d 1780 (Fed. Cir. 2014) seems to be germane to the instant case. In Abbvie, an analogy is drawn between a claimed genus and a plot of land (see pages 1789-1791). Using this analogy, the Court offered that “[I]f the disclosed species only abide in a corner of the genus, one has not described the genus sufficiently to show that the inventor invented, or had possession of, the genus. He only described a portion of it.” Similar to the analogy drawn in Abbvie, in the case of Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed. Cir. 2010), the court (at page 1171) offered: [M]erely drawing a fence around the outer limits of purposed genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
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 13 and 14 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 is indefinite because at lines 4-5, “listed in Table 1” fails to set forth the metes and bounds of the claimed invention. 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 by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).
Claim 14 is indefinite because at line 1, “derived from” and at line 5, “derived directly from” imply a product-by-process but the instant claim fails to recite any process steps. Hence, the metes and bounds of the claim are unclear.
At claim 14, line 2, “a culture of claim 13” is indefinite because it is unclear what the limitation refers to. Hence, the metes and bounds of the claim are unclear.
Conclusion
No claims are allowed.
Claims 13 and 14 appear to be free of the prior art. The Examiner finds no prior art reference to line J1909-s40 or parental line B18287-s82 or WBL-s290 or the parental line’s associated heterokaryotic line from which it was isolated. The closest prior art is Kerrigan et al (U.S. Patent 10,440,930 which teaches homokaryons isolated from heterokaryotic line J11500 in Table VI at column 28. The prior art homokaryon differs from the instantly claimed invention at the ITS, AS and FF marker/locus.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
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, 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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/David H Kruse/
Primary Examiner, Art Unit 1663