DETAILED ACTION
Claims 1-20 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The specification is objected because it does not provide all names for parents BRAWLCLPLUS and C006424 (¶17).
Deposit of Biological Material
This application requires public availability of specific biological material to make and use the claimed invention. A rejection under the appropriate sections of 35 USC 112 would have been made but for Applicant having made an acceptable deposit of the specific biological material in compliance with the requirements under 37 CFR 1.801-1.809. See ¶227.
Claim Rejections - 35 USC § 112
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 the second paragraph of 35 U.S.C. 112:
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 1-20 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 that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention. Dependent claims are included in all rejections.
Claim 1 is indefinite in its recitation of “plant of wheat cultivar 01102452, wherein a sample of seed of said cultivar has been deposited under NCMA Accession No. 202312013”, claim 9 is indefinite in its recitation of “a sample of seed of said cultivar has been deposited under NCMA Accession No. 202312013”, and claim 11 is indefinite in its recitation of “a sample of seed of wheat cultivar 01102452 has been deposited under NCMA Accession No. 202312013”. Claims 6 and 17 are indefinite in their recitation of “wheat cultivar 01102452”.
These claims, and those dependent upon them, are indefinite because of the definition of “wheat plant” in (¶116):
[0116] When the term "wheat plant" is used in the context of the present invention, this also includes any gene conversions of that cultivar. Backcrossing methods can be used with the present invention to improve or introduce a characteristic into the cultivar. For example, a variety may be backcrossed 1, 2, 3, 4, 5, 6, 7, 8, 9 or more times to the recurrent parent. The parental wheat plant that contributes the gene for the desired characteristic is termed the "nonrecurrent" or "donor" parent. This terminology refers to the fact that the nonrecurrent parent is used one time in the backcross protocol and therefore does not recur. The parental wheat plant to which the gene or genes from the nonrecurrent parent are transferred is known as the recurrent parent, as it is used for several rounds in the backcrossing protocol. In a typical backcross protocol, the original variety of interest (recurrent parent) is crossed to a second variety (nonrecurrent parent) that carries the single gene of interest to be transferred. The resulting progeny from this cross are then crossed again to the recurrent parent and the process is repeated until a wheat plant is obtained wherein essentially all of the morphological and physiological characteristics of the recurrent parent are recovered in the converted plant, in addition to the single transferred gene from the nonrecurrent parent.
It is not clear if this definition only applies when the phrase “wheat plant” is used or if it also applies when “wheat cultivar” or “ a plant of wheat cultivar” is used. The use of “cultivar” and “also includes” in this definition makes “wheat cultivar” and “wheat plant” appear to be interchangeable terms, as “the term ‘wheat plant’ … also includes any gene conversions of that cultivar” (emphasis added).
The closest the specification comes to definition for “single locus conversion” in the definition for “Single Locus Converted (Conversion) Plant” as follows (¶217):
[0217] Single Locus Converted (Conversion) Plant: Plants which are developed by a plant breeding technique called backcrossing and/or by genetic transformation to introduce a given locus that is transgenic in origin, wherein essentially all of the morphological and physiological characteristics of a wheat cultivar are recovered in addition to the characteristics of the locus transferred into the variety via the backcrossing technique or by genetic transformation. It is understood that once introduced into any wheat plant genome, a locus that is transgenic in origin (transgene), can be introduced by backcrossing as with any other locus.
The specification defines “essentially all of the phenotypic characteristics or morphological and physiological characteristics” in ¶169:
[0169] Essentially all of the morphological and physiological characteristics: The characteristics of a plant are recovered that are otherwise present when compared in the same environment, other than occasional variant traits that might arise during backcrossing or direct introduction of a transgene.
It is not clear what is meant by “occasional variant traits”, as it is not clear how the time word “occasional” applies to a product. It is also not clear how many “variant traits” are encompassed by the phrase.
If a gene conversion is only required to have “essentially all” of the characteristics, it is not clear how many of the characteristics the plant is required to have and how many it is not required to have.
The instant specification provides a trait table containing a description of wheat cultivar 01102452 (Table 1). Given the definition above, it is not clear if this description valid for ALL plants of wheat cultivar 01102452 or if this description valid only for the non-converted plants within wheat cultivar 01102452. It is not clear if the plants utilized to collect the traits for this trait table grown from the same batch of seeds as the seeds that will be deposited or if there a locus conversion/gene conversion between the seeds that will be deposited and the seeds utilized to grow plants for the data in the trait table.
Given that “wheat plant” is inclusive of gene conversions that allow for having changes in the morphological and physiological characteristics, it is unclear which characteristics are absolutely required to be a member of this cultivar.
Thus, it is not clear if plants of “wheat cultivar 01102452” encompasses variant plants with any number of gene conversions, with all the issues that implies, as discussed above, or if plants of “wheat cultivar 01102452” only mean plants of a given genotype.
Similarly, it is not clear how the deposited seeds are “representative” of the cultivar. It is not clear if the deposited seeds already have any gene conversions, and if so, what the single gene conversion relative to. Because the plants of the “cultivar” appear to encompass plants with single gene conversions, it is important to have a very clear definition of what a non-converted plant of the cultivar is.
If the phrase “wheat plant” does not encompass “wheat cultivar”, it is not clear if the definition in ¶116 only applies when “wheat plant” is used or if “wheat seed” is also encompassed. The definition of “plant” includes “seeds” (¶202):
[0202] Plant: As used herein, the term plant includes reference to an immature or mature whole plant, including a plant from which seed, grain, or anthers have been removed. A seed or embryo that will produce the plant is also considered to be a plant.
Thus, it, regardless whether “wheat plant” encompasses “wheat cultivar”, the definition in ¶116 applies when “wheat seed” is recited, as in claims 5, 7, 17, and 19.
For purposes of examination, it was assumed that “wheat plant”, “wheat seed”, and “wheat cultivar” “includes any gene conversions of that cultivar”. Such treatment does not relieve Applicant of the responsibility to respond to this rejection.
Claim 6 is indefinite in its recitation of "further comprising crossing the plant of wheat cultivar 01102452 with a second, distinct wheat plant to produce an Fi hybrid wheat seed". In parent claim 5, the plant of claim 1 (i.e., a plant of wheat cultivar 01102452) is crossed with itself or a second wheat plant to produce a wheat seed. Claim 6 does nothing with the product of the cross of claim 5, but instead performs another cross with a plant of wheat cultivar 01102452. It is not clear if that is what Applicant intended, or if Applicant intended to further define the cross performed in claim 5.
Claims 14-15 lack antecedent basis for the limitation “the single locus” in line 1.
Claims 11-12 and 16 are indefinite in their recitation of “single locus conversion” and claims 14-15 are indefinite in their recitation of “single locus”, which is interpreted here to mean “single locus conversion”.
These claims confuse things further because they are directed to plants further comprising a single locus conversion; however, the instant specification defines “wheat plant” to already include gene conversions.
It is not clear if “a single locus conversion” means one and only one locus conversion. The common meaning for “single” means just one, i.e., “single locus conversion” means one and only one locus conversion. However, this claim encompasses adding one to a plant that already has gene conversions, which results in more than a “single”. Additionally, the specification defines “a” in ¶149 as “A: When used in conjunction with the word ‘comprising’ or other open language in the claims, the words ‘a’ and ‘an" denote ‘one or more.’” This definition of “a” indicates that multiple locus conversions are encompassed by “comprising a single locus conversion”. If “a” does not provide any limitation on the number of gene conversions/locus conversions that are encompassed by these claims, then “single” does not mean one and only one. As “wheat cultivar 01102452” already “includes any gene conversions of that cultivar”, it is not clear how a plant of wheat cultivar 01102452 further comprising a single locus conversion differs from a plant of wheat cultivar 01102452.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1-20 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The definitions and interpretations of the phrases “wheat plant”, “wheat seed”, “wheat cultivar 01102452” and “single gene conversion” presented in the rejection under 35 U.S.C. 112(b) above are incorporated herein.
The instant claims are broadly drawn to plants and seeds of wheat cultivar 01102452, and plants and seed derived from said cultivar, and methods of using said cultivar.
Under the interpretation that “wheat cultivar 01102452” encompasses any “gene conversions of that cultivar”, the specification does not describe the full scope of 01102452 plants with unspecified numbers of locus conversions relative to the plant described in Table 1.
The recitation in (¶175) that “gene converted” plants “refers to plants that are “developed by backcrossing, genetic engineering, or mutation, wherein essentially all of the morphological and physiological characteristics of a variety are recovered, in addition to the one or more traits transferred into the variety via the backcrossing technique, genetic engineering, or mutation” means that plants with variant traits are encompassed by “single gene conversions” as well as by “wheat plant” and “wheat cultivar”.
The specification does not describe wheat plants with an unspecified number of “variant traits” relative to “wheat cultivar 01102452”, whether “wheat cultivar 01102452” means only plants with a single fixed genome or plants that are some genus of genetics and/or morphological and physiological characteristics.
As locus converted plants have “essentially all of the morphological and physiological characteristics of a variety” (¶67), locus converted plants of wheat cultivar 01102452 have an unspecified number of differences from plants wheat cultivar 01102452. Further, claims 11-16, which are drawn to a “wheat plant of wheat cultivar 01102452, further comprising a single locus conversion” encompasses a cultivar 01102452 wheat plants with gene conversions and further comprising locus conversions.
It is also not clear how the deposit describes the full scope of plants of wheat cultivar 01102452.
The specification describes no structural features that distinguish plants of “wheat cultivar 01102452” from other wheat plants. The specification does not describe the structural features and/or morphological and physiological characteristics that are required for a plant to be of “wheat cultivar 01102452”.
The specification describes no structural features that distinguish wheat plants that differ from morphological and physiological characteristics of wheat cultivar 01102452 in any number of traits from other wheat plants.
Under the interpretation that “wheat plant” means a plant includes any single gene conversions only when the phrase “wheat plant” is recited, and that the specification does not describe wheat cultivar 01102452 plants further comprising any number of single locus conversions as encompassed by the definition of “a” in ¶149.
The specification describes no structural features that distinguish plants of “wheat cultivar 01102452, further comprising a single locus conversion” from other wheat plants. The specification does not describe the structural features and/or morphological and physiological characteristics that are required for a plant to be of “wheat cultivar 01102452 further comprising a single locus conversion”.
The specification describes no plants that differ from morphological and physiological characteristics of wheat cultivar 01102452 in an unspecified number of traits. The specification only describes a plant with the traits in Table 1.
Hence, Applicant has not, in fact, described the claimed wheat plants over the full scope of the claims, and the specification fails to provide an adequate written description of the claimed invention.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
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 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], 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 19-20 are rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112(pre-AIA ), fourth 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 19 is drawn to a method comprising applying plant breed techniques to the plant of claim 1 or an F1 hybrid thereof. If the method is one of applying plant breed techniques to an F1 hybrid, the method does not use the plant of parent claim1. Thus, the claim fails to include all the limitations of the claim upon which it depends
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 §§ 102, 103
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.
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.
Claims 1-20 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 Perry (2019, US 10,362,751).
The definitions and interpretations of the phrases “wheat plant”, “wheat seed”, “wheat cultivar 01102452” and “single gene conversion” presented in the rejections under 35 U.S.C. 112(a) and (b) above are incorporated herein.
The claims are drawn to plants and seeds of wheat cultivar 01102452, methods of using it, and products and plants produced from it.
Perry teaches plants of wheat cultivar 01071571 (table 1). These plants appear to be species in the genus of plants that are wheat cultivar 01102452, as interpreted herein. The plant described in ‘751 shares the following traits listed in the instant Table 1 for wheat cultivar 01102452: erect orientation, twisted twist, presence of waxy bloom, yellow anther color, anthocyanin absent on stem, presence of anthocyanin on auricle, hollow internode form, hairiness present on last internode of rachis, semi-erect peduncle, present of anthocyanin on auricle, tapering head shape, inclined head curvature, awned head, white glumes, narrow glume shoulder, acuminate glume beak shape, medium glume beak width, absence of glume pubescence, rounded seed cheek, medium seed brush, no brush collar, crease width of 0.6, red seed color, and hard seed texture.
‘751’s claims 1-20 are identical to the instant claims 1-20, respectively, except for the name of the variety.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of US Patent No. 10,362,751.
The definitions and interpretations of the phrases “wheat plant”, “wheat seed”, “wheat cultivar 01102452” and “single gene conversion” presented in the rejections under 35 U.S.C. 112(a) and (b) above are incorporated herein.
‘751 discloses plants of wheat cultivar 01071571 (table 1). These plants appear to be species in the genus of plants that are wheat cultivar 01102452, as interpreted herein. The plant described in ‘751 shares the following traits listed in the instant Table 1 for wheat cultivar 01102452: erect orientation, twisted twist, presence of waxy bloom, yellow anther color, anthocyanin absent on stem, presence of anthocyanin on auricle, hollow internode form, hairiness present on last internode of rachis, semi-erect peduncle, present of anthocyanin on auricle, tapering head shape, inclined head curvature, awned head, white glumes, narrow glume shoulder, acuminate glume beak shape, medium glume beak width, absence of glume pubescence, rounded seed cheek, medium seed brush, no brush collar, crease width of 0.6, red seed color, and hard seed texture.
‘751’s claims 1-20 are identical to the instant claims 1-20, respectively, except for the name of the variety.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anne R. Kubelik, Ph.D., whose telephone number is (571) 272-0801. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham, can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Anne Kubelik/Primary Examiner, Art Unit 1663