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 .
Claims 1 and 11 are amended. Claims 12-14, 18-20, 22, and 24 are canceled. Claims 1-11, 15-17, 21, and 23 are pending.
Election/Restrictions
Applicant’s election without traverse of Group II, including claims 1- 11, 15-17, 21, and 23 in the reply filed on 09/19/2025 is acknowledged.
Claims 1-11, 15-17, 21, and 23 are examined herein. The Restriction Requirement is made FINAL.
Specification
The specification is objected for lacking a deposit date and/or a deposit number: on pages 4, 5, 43, and 44, for example, the deposit date or deposit number information is missing. It is assumed that Applicant will provide the appropriate information in response to the instant Office action.
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 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 1-11, 15-17, 21, and 23 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.
Claims 1, 11, 15, and 23 are rejected as being indefinite in their recitation "NCIMB Accession Number X2" because the NCIMB Accession Number is missing. Therefore, the metes and bounds of the claims are not clear. Amending the claims to recite the NCIMB accession number once the deposit is perfected, would overcome the rejection.
Claims 1, 11, 15, 16, and 23, are also rejected as being indefinite in their recitation of hybrid pepper plant or seed “E20S0465” because the recitation does not clearly identify the claimed plant cultivar and seed. Furthermore, the recitation does not set forth the metes and bounds of the claimed invention. Since the name “E20S0465” is not known in the art, the use of said name does not carry art recognized limitations as to the specific characteristics or essential characteristics that are associated with that denomination. In addition, the name appears to be arbitrary, and the specific characteristics associated therewith could be modified, as there is no written description of the plant that encompasses all of its traits. This rejection could be obviated by amending the claims to recite the NCIMB accession number once the deposit is perfected.
Dependent claims are also rejected because they fail to overcome the deficiencies of parent claims.
Claim 5 is further rejected as being indefinite for the recitation of a pepper plant having all or “substantially all” of the physiological and morphological characteristics of the pepper plant of claim 2. Regarding the term “substantially”, while it is generally a broad term and not indefinite per se, the acceptability of the term depends on whether it can be interpreted by a person of ordinary skill in the art with reasonable certainty. In the instant case, the physiological and morphological characteristics of the pepper plant is described in the Specification, pp 21-24. While the Specification describes some of the physiological and morphological characteristics, such as a number of disease resistance traits, growth habit, flower color, etc., such description is far from complete. Furthermore, it is not clear which of the listed physiological and morphological characteristics should or could be omitted by the claimed progeny plants to qualify as having “substantially all” of the characteristics. As such, a person of ordinary skill would not, with reasonable certainty, to interpret the scope of the claimed plants regarding the spectrum of the physiological and morphological characteristics.
Similarly, claim 11 is further rejected as being indefinite for the recitation of the pepper plant regenerated from tissue or cell culture has all or “essentially all” of the morphological and physiological characteristics of a pepper plant produced by growing hybrid pepper seed designated as ‘E20S0465’. The Specification has not adequate defined the term “essentially all” such that a person of skill in the art would understand the metes and bounds of the claim. It is unclear how many differences are allowed, the degree of difference that is permitted, nor which traits are "essential" and must be retained. The Specification has not defined any plants having less than “all” of the characteristics. This is issue is especially important given the fact that tissue or cell culture often introduce somaclonal variations in the regenerated plants (See for example in Bello-Bello, et al. (2014). Somaclonal Variation in Habanero Pepper (Capsicum chinense Jacq.) as Assessed ISSR Molecular Markers. HortScience, 49(4), 481–485., for detailed discussion). Thus, it is not clear which of the listed physiological and morphological characteristics should or could be omitted by the claimed progeny plants to qualify as having “essentially all” of the characteristics. As such, a person of ordinary skill would not, with reasonable certainty, to interpret the scope of the claimed plants regarding the spectrum of the physiological and morphological characteristics.
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 1-11, 15-17, 21, and 23 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 invention appears to employ the seed of novel plants. Since the seed claimed is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If a seed is not so obtainable or available, the requirements of 35 U.S.C. 112 may be satisfied by a deposit thereof. The specification does not disclose a repeatable process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public.
If the deposit of the seed 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 seed have been deposited under the Budapest Treaty and that the seed 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. In the instant case, the Specification has not explicitly stated that subject to paragraph (b) of 37 CFR 1.808, all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent.
Although the rules do not specify a specific number of seeds to be deposited to meet the requirements of these rules, so long as the number of seeds deposited complies with the requirements of the Budapest Treaty International Depositary Authority (IDA) where the deposit is made, the USPTO would consider such a compliant submission as satisfying the rules under 37 CFR 1.801 through 1.809. Note that the American Type Culture Collection (ATCC), a Budapest IDA, requires a minimum deposit of 625 seeds; other IDAs may have different minimum requirements. Accordingly, any depositor should confirm that the number submitted to a specific IDA complies with that IDA's requirements for seed deposits.
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.
Applicant has NOT indicated that Applicant intends to deposit the seeds at the ATCC in accordance with 37 CFR 1.801-1.809. Accordingly, Applicant needs to provide a signed statement indicating compliance with 37 CFR 1.801-1.809, the ATCC Accession No. and evidence of deposit to overcome this rejection. Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Written Description Regarding Missing Breeding History
Claims 1-11, 15-17, 21, and 23 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 instant Specification fails to satisfy the written description requirement of 35 U.S. Code § 112(a) because it does not provide a description sufficient to conduct an examination, including search of the prior art, nor does it provide enough description to be sufficient to aid in the resolution of questions of infringement.
MPEP 2163 (I) states “The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985); see also 54 Fed. Reg. at 34,880 ("As a general rule, the more information that is provided about a particular deposited biological material, the better the examiner will be able to compare the identity and characteristics of the deposited biological material with the prior art.").”
MPEP 2163(I) states “The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement." Id. at 34,880.)” (Quoting the Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) at 34,880).
In the instant application, a full examination cannot be conducted because applicant failed to provide the full breeding history for the instantly claimed plant variety. Specifically, in claim 1, Applicant claims a broad genus of new hybrid pepper plant variety. A plant variety is defined by both its genetics (breeding history) and its traits.
Applicant claims any plant of hybrid pepper line E20S0465, or any progeny plant or regenerated plant from pepper line E20S0465. It should be noted that the plant of hybrid pepper hybrid E20S0465 is only one species of this broad genus.
In the instant application, applicant only provided a description of the physiological and morphological characteristics for hybrid pepper plant E20S0465, (e.g., Specification pp. 21-24). However, the Specification does not describe the parental lines was used to breed for the hybrid pepper E20S0465; or the breeding method and process by which the hybrid pepper E20S0465 were obtained, and if hybrid pepper E20S0465, or either or both of the parental lines used to breed hybrid pepper E20S0465 have any other known designation. Therefore, the instant application is incomplete as to the breeding history used to produce the claimed plant variety.
The criticality of a breeding history in assessing the intellectual property rights of a plant is well recognized in the field of plant breeding. With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”. Other bodies that grant intellectual property protection for plant varieties require breeding information to evaluate whether protection should be granted to new varieties. A breeding history, including information about parentage and breeding methodology, is part of the requirements of Plant Variety Protection (PVP) applications. That information is used to “determine if development is sufficient to consider the variety new” (See “Applying for a Plant Variety Certificate of Protection” by the USDA reference to Exhibit A). Additionally, the International Union for the Protection of New Varieties of Plants (UPOV) considers breeding history and methodology part of its evaluation of essentially derived plant varieties (See UPOV EDV Explanatory Notes 14 and 30). While the USPTO, USDA, and UPOV have different laws governing intellectual property rights, all recognize that a breeding history is an essential part of adequate description of the plant sought to be protected.
The breeding history is also necessary to aid in the resolution of patent infringement by providing information necessary to determine whether differences in plants where genetic differences, differences caused by the environment, or differences within the accepted variation within a variety. Historically, the USPTO has considered breeding history information when determining the patentability of a new plant variety. (See Ex Parte C (USPQ 2d 1492 (1992) and Ex Parte McGowen- Board Decision in Application 14/996,093). In both of these cases, there were many differences cited by the applicant when comparing the prior art and the new plant variety. However, because the breeding history was available, these differences were deemed to be obvious and within the natural variation expected in a backcrossing breeding process. Without a breeding history in these cases, a complete comparison with the prior art could not have been possible.
Moreover, a specification devoid of a breeding history hampers the public’s ability to resolve infringement analysis with plants already in the prior art as well as plants that have not yet been patented. Because the instant specification lacks the breeding history, the public will not be able to fully resolve questions of infringement. Since the breeding history, including the parents, is not known to the public, the public could only rely on the phenotypes of the claimed plants for assessing potential infringement.
As seen above in Ex Parte C and Ex Parte McGowan, a trait table is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species. HAUN teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (See Haun Page 645 Left column). Segregation, recombination, DNA transposition, epigenetic processes, and spontaneous mutations are some of the reasons elite cultivar populations will maintain some degree of plant-to-plant variation. (See Haun Page 645 right column and Page 646 left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (See Großkinsky page 5430 left column 1st full paragraph and right column 2nd full paragraph). In view of this variability, a breeding history is an essential and the least burdensome way to provide genetic information needed at adequately describe a newly developed plant.
Thus, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention.
To overcome this rejection, applicant must amend the Specification or Drawing to provide the breeding history used to develop the instant variety or cultivar. When identifying the breeding history, applicant should identify any and all other potential names for all parental lines utilized in the development of the instant variety. For example, if applicant’s breeding history uses proprietary line names, applicant should notate in the specification all other names of the proprietary lines, especially publicly disclosed or patented line information. If the breeding history encompasses a locus conversion or a backcrossing process, applicant should clearly indicate the recurrent parent and the donor plant and specifically name the trait or transgenic event that is being donated to the recurrent parent. If one of the parents is a backcross progeny or locus converted line of a publicly disclosed line, applicant should provide the breeding history of the parent line as well (i.e. grandparents).
Applicant is also reminded that they have a duty to disclose information material to patentability. Applicant should also notate the most similar plants which should include any other plants created using similar breeding history (such as siblings of the instant variety). This information can be submitted in an IDS with a notation of the relevancy to the instant application or as information submitted as described in MPEP 724 (e.g., trade secret, proprietary, and Protective Order).
Written Description
regarding progeny plants or regenerated plants
Claims 5, and 11 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.
As discussed above, claims 5 and 11 are broadly drawn to pepper plants having “substantially all” of the physiological and morphological characteristics of the pepper plant of claim 2, or pepper plant regenerated from tissue or cell culture has all or “essentially all” of the morphological and physiological characteristics of a pepper plant produced by growing hybrid pepper seed designated as “E20S0465”.
Regarding claim 5, it should be noted the claim merely rely on the resemblance to the pepper plant of claim 2 by an incomplete description of identifiable traits. The claim does not describe the underlying genetic linkage or basis for such resemblance. Regarding claim 11, The claims are broadly drawn to pepper plants that have “essentially all of the physiological and morphological characteristics” of pepper plants regenerated from a tissue or cell of “E20S0465”.
The Specification has described some of physiological and morphological characteristics of hybrid pepper “E20S0465” in the Specification. It should be noted that the deposit has not been perfected. The breeding history to produce “E20S0465” has not been disclosed. Furthermore, Applicant asserts that E20S0465 is uniform and stable, while without the assurance from the breeding method and history.
The Specification does not describe any other pepper plant that does not comprise all of the physiological and morphological characteristics of the pepper plant “E20S0465”. As discussed above, the phrases “substantially all” or “essentially all” is not adequately defined such that a person of skill in the art would understand the metes and bounds of the claim. It is unclear how many differences are allowed, the degree of difference that is permitted, nor which traits are “essential” and must be retained. Plants having less than “all” of the characteristics have not been described.
Thus, the claim will read on a genus of plant that are genetically and phenotypically distinct from the described inbred variety. The described plant is not sufficiently representative of the genus.
See Vas-Cath Inc. v. Mahurkar 1991 (CA FC) 19 USPQ2d 1111, 1115, which teaches that the purpose of the written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his infringement of the patent; and at the same time, of taking from the inventor the means of practicing upon the credulity or the fears of other persons, by pretending that his invention is more than what it really is, or different from its ostensible objects, that the patentee is required to distinguish his invention in his specification. In this case, there is no way that a practitioner would be able to determine if any particular maize plant is infringing the instant claims, and therefore, the public has not been put on notice with a sufficient description of the claimed invention.
These claims are “reach through” claims in which the Applicant has described a starting material and at least one method step, however, they have not described the resulting product, and the genus of products that can be produced by the recited method steps and materials is so large that one of skill in the art is not able to envision the members of the genus. (See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004)).
Accordingly, the specification fails to provide adequate written description to support the genus of maize plants produced by introducing a locus conversion or a transgene into maize variety 1PLUB62, which itself encompasses maize plants with any number of locus conversions, transgenes or mutations. Therefore, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
Conclusion
No claims are allowed.
Claims 1-11, 15-17, 21, and 23 are deemed to be provisionally free of the prior art, given the failure of the prior art to teach or suggesting a hybrid pepper plant having all of the morphological and physiological characteristics of the claimed hybrid or the parental lines as deposited. It should be noted that this statement is based only on a comparison of the morphological and physiological characteristics as disclosed, against the prior art. This is statement is provisional because Applicant has not provided any information regarding the parental lineage or breeding methodology used to produce the claimed hybrid pepper line E2080465. Without this information, a meaningful comparison of the genetic and phenotypic basis that would distinguish the claimed pepper variety from prior art plants cannot be made. Thus, this statement will remain provisional until the necessary information (see Written Description rejection above) is received, corrections are made to the description, and a complete search of the prior art is can be completed.
The closest prior art is McCarthy (US8013222B2) which teaches a Sweet pepper hybrid 9954288 and the parent lines thereof, which shares many traits in common (or does not significantly differ) with instant hybrid pepper plants. However, the plants differ in at least the anther color, disease resistance spectrum, and genetic makeup.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WEIHUA FAN whose telephone number is (571)270-0398. The examiner can normally be reached Monday-Friday, 9-5.
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 A 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.
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.
WEIHUA . FAN
Examiner
Art Unit 1663
/WEIHUA FAN/Examiner, Art Unit 1663