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 .
This Office action is directed to the amended Claims and Specification filed 8 August 2023.
Specification
The Specification is objected to because on page 19, paragraph 0016, the Specification makes reference to color drawings but the instant Specification does not contain any color drawings or the required Petition.
Paragraph 0001 on page 1 of the Specification is objected to. The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
Claim Objections
Claims 1-10 are objected to because of the following informalities: 37 C.F.R. 1.75(i) states that “Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation”.
Further, claim 1, for example should not use “(1)” to denote steps and said claim 1(1) comprises multiple substeps which should be at least similarly indented as addressed above.
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 1-10 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.
Applicant claims a breeding method of a long-staple cotton variety allowing spinning [of] 150 N to 340 N combed cotton yarns beginning with a Gossypium barbadense radiation-mutant BMC0318 as a female parent to produce long-staple cotton variety BMC69 at claim 1, claim 6.
Applicant describes radiation-mutant BMC0318 being produced using 60Co-g irradiation of the Xinhai 21 variety in Figure 1.
Applicant does not describe any specific mutation found in radiation-mutant BMC0318 and does not describe long-staple cotton variety BMC69 other than by an unreproducible method of making. Applicant does not describe intermediate varieties like BMC049 or BMLK052 other than by how they were made.
Hence, it is unclear that Applicant was in possession of the invention as broadly claimed. A method is not described if products used in the method are not described. See 64 Fed. Reg. 71427, 71428 (1999), comment No. 4. See University of Rochester v. G.D. Searle & Co., 68 USPQ2d 1424, 1433 (DC WNY 2003) which teaches knowing the "starting point" is not enough; that is little more than a research plan. The court held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112.
Claims 1-10 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.
Applicant claims a breeding method of a long-staple cotton variety allowing spinning [of] 150 N to 340 N combed cotton yarns beginning with a Gossypium barbadense radiation-mutant BMC0318 as a female parent to produce long-staple cotton variety BMC69 at claim 1, claim 6.
Applicant teaches radiation-mutant BMC0318 being produced using 60Co-g irradiation of the Xinhai 21 variety in Figure 1.
Applicant does not teach a reproducible method for making radiation-mutant variety BMC0318, variety BMLK052, variety BMC049 or variety BMC69. Further, Applicant does not teach cotton variety Xinhai 21, variety Giza 45, variety Xinluzhong or variety Xinhai 40 as being widely publicly available to one of skill in the art. At claim 1, Applicant cannot provide assurance that one of skill in the art can practice the claimed invention “in Sanya of Hainan” or the “mixed disease nursery of Xinxiang” which appears to be locations in China required to practice the claimed method.
In re Wands, 858F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988) lists eight considerations for determining whether or not undue experimentation would be necessary to practice an invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claims.
First, reproducing the production of radiation-mutant variety BMC0318 from variety Xinhai 21 would be highly unpredictable especially because radiation-mutant variety BMC0318 is not readily available as a means of comparison. It is the nature of the instant invention that producing mutations and backcross progeny is not predictable. Hence, it would have required undue trial and error experimentation to make and use the invention as claimed.
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 1-10 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.
The limitations radiation-mutant variety BMC0318, variety BMLK052, variety BMC049 or variety BMC69, variety Xinhai 21, variety Giza 45, variety Xinluzhong or variety Xinhai 40 are indefinite because they are not art standard names for cotton varieties. The sole designation of a plant by its breeding line name or number is arbitrary and creates ambiguity in the claims. For example, the plant disclosed in this application could be designated by some other arbitrary means, or the assignment of the breeding line name could be arbitrarily changed to designate another plant. If either event occurs, one’s ability to determine the metes and bounds of the claim would be impaired. See In re Hammack, 427 F .2d 1378, 1382; 166 USPQ 204, 208 (CCPA 1970). Amendment of the claim to refer to the deposit accession number of the claimed breeding line would obviate this rejection.
At claims 2 and 7, the phrase “strong growth potential” is relative and the claims fails to set forth to which the limitation is relative to.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), 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.
Claims 7-10 are 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. The instant claims do not further limit cotton variety BMC69 of claim 6, said claims appear to further limit the method by which the cotton variety BMC69 is/was made. 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.
Conclusion
No claims are allowed.
The claims appear to be free of the prior art. The closest prior art is Chen et al (AU 2020103667 A4) which teaches a long-staple cotton Xiang C176 (see Abstract) that share similar traits with instant variety BMC69. The prior art cotton variety differs by it’s parental lines and method of making.
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.
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/David H Kruse/
Primary Examiner, Art Unit 1663