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
Status of claims
1. Claims 1-23 are pending. Claims 1-23 are examined on merits in the present Office action.
Information Disclosure Statement
2. Initialed and dated copies of Applicant’s IDS form 1449 filed in the paper of 11/01/2024 is attached to the instant Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
3. The disclosure is objected to because of the following informalities:
Accession number is missing throughout the specification.
Pages 24-25 of the specification: The deposit statement lacks NCIMB Accession No. and the date deposit was made.
Appropriate corrections are required.
Claim Objections
4. Claims 1, 9, 13, 19-23 are objected to because of the following informalities:
In claims 1, 9, 13 and 23, the recitation “, respectively,” should be deleted. It appears to be typological error.
In claim 19, lines 2-3, the recitation “seed of a claim 1” should be replaced by-- seed of claim 1 – for clarity of the claimed subject matter.
In claim 20, line 2, the recitation “of a plant of claim 2” should be replaced by-- of the plant of claim 2--- for clarity of the claimed subject matter.
In claim 21, line 2, the recitation “of a plant of claim 2” should be replaced by-- of the plant of claim 2--- for clarity of the claimed subject matter.
In claim 22, line 1, the recitation “plants” does not have proper antecedent basis. Appropriate claim amendments should be made.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
5. Claims 1-23 are rejected under 35 U.S.C. 112(b), 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.
Claims 1, 3, 8, 9, 13, 16, 17 and 23 are rejected under 35 U.S.C. 112(b), as being indefinite in their recitation “Accession No.-____” because the “Accession No” is missing.
Claims 1, 8, 9, 13, 14, 16, 17 and 23 are rejected under 35 U.S.C. 112(b) as being indefinite in their recitation wild rocket variety “SIMLOPS” because the recitation does not clearly identify the claimed wild rocket variety and seed. Furthermore, the recitation does not set forth the metes and bounds of the claimed invention. Since the name “SIMLOPS” 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 wild rocket plant that encompasses all of its traits. This rejection can be obviated by amending the claims to recite the NCMA Accession number.
Dependent claims are also rejected because they fail to overcome the deficiencies of parent claims.
Claim Rejections - 35 USC § 112(a), deposit
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 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.
6. Claims 1-23 are rejected under 35 U.S.C. 112(a) 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.
It is noted that the specification states that seed deposit was made with NCIMB. However, accession number and date of deposit is missing. Also, the deposit statement needs to be perfected (see pages 24-25).
Since the seed claimed 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 seed 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 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. A minimum deposit of 625 (25 packets of 25 seeds each) seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
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.
Claim Rejections - 35 USC § 112(a), (Written Description)
7. Claim 15 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(s), at the time the application was filed, had possession of the claimed invention.
The Federal Circuit has recently clarified the application of the written description requirement. The court stated that a written description of an invention "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials." University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). The court also concluded that "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material." Id. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus." Id.
Finally, the court held:
A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus. Id.
See also MPEP Section 2163, page 174 of Chapter 2100 of the August 2005 version, column 1, bottom paragraph, where it is taught that
[T]he claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.
See also Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ 2d 1016 at 1021, (Fed. Cir. 1991) where it is taught that a gene is not reduced to practice until the inventor can define it by "its physical or chemical properties" (e.g. a DNA sequence).
Claim is broadly drawn to a seed produced by the method of claim 13.
The breadth of claim 13 is directed to producing an F1 hybrid wild rocket plant using variety SIMLOPS as one of the parental lines.
The breadth of claim 14 is directed to further crossing said F1 hybrid with itself or a second wild
rocket plant to produce an F2 progeny.
Thus seed of claim 15 can also read on segregating population because parent claim 13 part (b) recites “whereby seed of a SIMLOPS-derived wild rocket plant forms”. The recitation “derived” can be interpreted that there is no limit what claim could encompass as claimed in claim 14.
Applicant’s broadly claimed genus encompasses a genus with unknown species whose structure and function relationship is unknown and not described. The specification describes morphological characteristics of the wild rocket plant variety SIMLOPS and relative comparison with a second commercial wild rocket variety. See in particular, pages 9-10, Table 1.
The specification does not describe progeny of wild rocket variety SIMLOPS beyond the
F1 hybrid, said F1 hybrid should comprise a complete set identifiable genetic elements from wild rocket variety SIMLOPS. This implies that it is unclear whether the Applicant was in possession of the invention as encompassed by the breadth and scope as claimed.
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. It light of this, it is unclear that Applicant was in possession of the invention as broadly claimed.
Applicant fails to describe structure of representative species of Applicant’s broadly claimed genus and thus their function is either unknown or unpredictable.
There is no description of the structure required for the recited function, and no description of the necessary and sufficient elements of functional activity of diverse species involved in obtaining the desired functional phenotype. Applicant’s broadly claimed genus encompasses structures whose function is unknown.
One of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the disclosed species. Since the disclosure fails to describe the common attributes that identify members of the genus, and because the genus is highly variant, species wild rocket variety SIMLOPS, representative seeds of which are to be deposited under NCMA Accession Number is insufficient to describe the claimed genus.
Accordingly, there is lack of adequate description to inform a skilled artisan that applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines published Federal Register/Vol.66, No. 4/Friday, January 5, 2001/Notices; p. 1099-1111.
Given the claim breadth and lack of guidance as discussed above, the specification does not provide written description of the genus broadly claimed. Accordingly, one skilled in the art would not have recognized Applicants to have been in possession of the claimed invention at the time of filing. The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
Claim Rejections - 35 USC § 112 (Written Description- Lack of Breeding History)
8. Claims 1-23 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 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.
35 USC 112 (a) states that “The specification shall contain a written description of the invention”. In evaluating written description, the threshold question is what is “an adequate written description”. This is question of fact that is evaluated by the factfinder (examiner). MPEP 2163.04 clearly states that “The inquiry into whether the description requirement is met must be determined on a case-by-case basis and is a question of fact. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976).”
The instant invention is a new wild rocket variety SIMLOPS. So, the examiner will evaluate what is an adequate written description for a new wild rocket variety SIMLOPS. In reviewing this question of fact, the examiner analyzed how plant varieties are evaluated in the public domain. The review concluded that generally the minimum requirements for an adequate description of a new plant variety has a trait table and genetic information (via a breeding history). In reviewing applicant’s specification there is a phenotypic description as is seen in tables 1 and 2. However, there is no accompanying breeding history in the specification. Because the specification lacks a breeding history and that breeding history is part of the minimum description of a plant variety the applicant has not fulfilled the requirement of 35 USC 112(a) to provide a written description in the specification. The office’s reasonable basis for challenging the adequacy of written description is informed by a review of the following:
With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”.
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”, USDA, https://www.ams.usda.gov/services/pv po/application-help/apply, downloaded 05/01/2023, (U)).
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 (UPOV, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, April 6, 2017, See UPOV EDV Explanatory Notes 14 and 30 (V)).
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) (W) and Ex Parte McGowen Board Decision in Application 14/996,093, decided June 15, 2020 (X)). 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.
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 et al. (Plant Physiology, Feb. 2011, Vol. 155, pp. 645-655 (Y)) teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (p. 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 (p. 645, right column and p. 646, left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al., J. Exp. Bot., Vol. 66, No. 11, pp. 5429-5440, 2015 (Z), p. 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 to adequately describe a newly developed plant.
The above factual evidence provides a reasonable basis that a breeding history is necessary written description. With this information the examiner has met the initial burden of presenting by a preponderance of evidence why a person of ordinary skill in the art would not recognize in an applicant’s disclosure a description of the invention defined by the claims. (See MPEP 2163.04). Please note, the citations above are not for legal authority, the legal authority relied upon by the examiner is the 35 USC 112(a) statute. The citations are presented to support the finding of fact that a breeding history is necessary to the adequate description of a plant.
Although not directly relied upon for the above written description position, a complete written description additionally helps drive examination and help with infringement verification.
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).
The breeding history aids in the resolution of patent infringement by providing information necessary to determine whether differences in the plants are genetic differences, differences caused by the environment, or differences within the accepted variation within a variety.
Moreover, a specification devoid of a complete 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 complete 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.
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/drawing to provide the breeding history used to develop the instant variety. 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 and all other potential names for the claimed variety. If Applicant’s breeding history uses proprietary variety names, Applicant should notate in the specification all other names of the proprietary varieties, especially publicly disclosed or patented variety 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 should identify the breeding method used, such as single seed descent, bulk method, backcross method, etc., and the filial generation in which the instant plant was chosen. Information pertaining to the homozygosity or heterozygosity of the parents as well as the instant plant should be set forth.
Applicant is 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). If there any patent applications or patents in which sibs or parents of the instant plant are claimed, the serial numbers and names of the sibs or parents should be disclosed. 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).
35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”. In the instant application, Applicant’s attention is drawn to the paragraph [0042] at page 8 of the specification which says:
[0042] “A detailed description of the development of wild rocket variety SIMLOPS is described in Table 1 and deposited with the NCIMB under deposit number_________ .”
However, it is noted that Table 1 only describes characteristics of SIMLOPS in comparison with a commonly known variety “Nature”.
Applicant included no breeding history for wild rocket variety SIMPLOS in the specification. No additional names for all parent(s) involved in creating wild rocket variety SIMPLOS is disclosed in the specification. This disclosure is insufficient or missing because it does not address all the issues set forth above.
Thus, the breeding history for the claimed variety as disclosed in the Specification is missing. Moreover, the claims indicate Applicant intends to deposit seeds representative of the claimed wild rocket variety SIMPLOS. It must be noted that there is natural variation in wild rocket plant caused by genetics and environment. Additionally, the specification at paragraph [0073] states the term “wild rocket variety SIMPLOPS” includes any locus incorporated in the variety during backcrossing, and said plant has essentially all the morphological and physiological characteristics of the variety [see paragraphs [0028]-[0029]. Thus, the claims are not directed to the deposited seeds or plants grown therefrom. The claims are directed to a genus of Wild rocket plants and seeds that are genotypically and phenotypically different from the deposit, and have different traits from those disclosed in the specification. Given these differences, the complete breeding history for producing the claimed variety, including all names for the parents and for the claimed variety, are material for patentability. A specification devoid of a complete breeding history hampers the public’s ability to fully resolve questions of infringement.
Conclusion
9. Claims 1-23 are rejected. The closest prior art Courtney (U.S. Patent Publication No. US 2021/0105963 A1, Published April 15, 2021) teach a Diplotaxis tenuifolia variety WRX-8 which share some characteristics (e.g. color of the leaf blade, leaf width, leaf division) of instant rocket variety SIMLOPS. However many other characteristics (e.g. leaf attitude, time of flowering, width of primary lobes etc.) are different.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vinod Kumar whose telephone number is (571) 272-4445. The examiner can normally be reached on 8.30 a.m. to 5.00 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A. 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA).
/VINOD KUMAR/ Primary Examiner, Art Unit 1663