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 46-65 are pending and examined on their merits herein.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 64-65 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claim 64 is drawn to a method for identifying and selecting a tomato plant comprising the steps of providing a plurality of tomato crop plants; examining a nucleic acid sample obtained from each of the plurality of the tomato crop plant for the presence of a Chr-1 QTL and Chr-7 QTL, thereby identifying a population comprising both QTLs; and examining the population comprising both QTLs for enhanced crop productivity compared to a corresponding plant comprising none or one of said QTLs or to a pre-determined productivity score value; thereby selecting a tomato plant characterized by an increased crop productivity compared to the control plant.
The claims recite a process which is one of the eligible categories of subject matter. (Step 1: YES).
The claim is then analyzed to determine whether it is directed to any judicial exception. The claim recites a step of examining a DNA sample, detecting a marker, and identifying a subject. These steps of are recited at a high level of generality that merely requires a comparison of data or information and imposes no limits on how the steps are performed. In Myriad CAFC, the court found this step of comparing to be an abstract idea.
It is apparent that the steps of examining, identifying and selecting could be performed by a human using mental steps or basic critical thinking. Similar mental processes have been held by the courts to be abstract ideas, e.g., collecting and comparing known information in Classen, or comparing information regarding a sample or test subject to a control or target data in Ambry and Myriad CAFC. The specific information that is being processed (responses from nematodes) merely narrows the abstract idea, which does not make the steps less abstract and is not sufficient to provide eligibility on its own. Thus, the claims are directed to an abstract idea (Step 2A: YES).
Next, the claims as a whole are analyzed to determine whether any additional element, or combination of elements, is sufficient to ensure that the claims amount to significantly more than the abstract idea. The claims recite the steps of examining, identifying and selecting, all of which were identified as the abstract idea explained above. There are no other elements/steps recited in the claims. This judicial exception is not integrated into a practical application. Accordingly, the claims as a whole do not amount to significantly more than the abstract idea of comparing information (Step 2B: NO). The claims are not patent eligible.
Claim 65 merely defines the specific sequence information therefore not adding significantly more to the abstract process discussed above.
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 46-63 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.
An “analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.” MPEP 2164.01. “A conclusion of lack of enablement means that. . . the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention [i.e. commensurate scope] without undue experimentation.” In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); MPEP 2164.01.
In In re Wands, 858 F.2d 731,8 USPQ2d 1400 (Fed. Cir. 1988), several factors implicated in determination of whether a disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue” are identified. These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). No single factor is independently determinative of enablement; rather “[i]t is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others.” MPEP 2164.01. Likewise, all factors may not be relevant to the enablement analysis of any individual claim.
In the instant Application, the claimed invention requires genetic elements comprising a Chr-1 QTL and a Chr-7 QTL of Solanum pennellii Lost Accession LA5240.
Applicant has provided teachings of mapping the QTL from a biparental BIL population, in which the “donor wild species for this resource was an unexplored accession of S. pennellii that was discovered in the Gatersleben collection (Lost Accession; LA5240; available at C.M. Rick Tomato Genetics Resource Center)” (Specification, p. 32-33).
Applicant has taught that the Chr-1 QTL comprises a polynucleotide sequence of the S. pennellii chromosome 1 from about 100.789953 cM to about 127.0420104 cM, or Chr-7 QTL comprising a nucleic acid sequence of the S. pennellii chromosome 7 from about 53.3003069 cM to about 56.96038414 cM. Applicant has taught the identifying marker sequences of SEQ ID NO: 1, 2, 5, 6, 7, and 10.
However, Applicant has not taught the nucleotide sequences of the functional elements of either or both of Chr-1 QTL and Chr-7 QTL. It is not clear which genes or genetic elements in the QTLs that would functional contribute to the tomato crop plant when expressed exogenously.
A skilled artisan has to rely on the availability of the genetic material, namely, “Lost Accession; LA5240”, in order to introgress the claimed QTLs into a tomato crop plant. Without access to the wild tomato line, a skilled artisan would not be make the claimed tomato crop plant. For example, SEQ ID NO: 1 is claimed to be an identifying feature for Chr-1 QTL. However, SEQ ID NO: 1 is 100% identical to a genomic sequence fragment located on Chr 7 of Solanum pennellii accession “LA0716" (Bolger, Anthony, et al. "The genome of the stress-tolerant wild tomato species Solanum pennellii." Nature genetics 46.9 (2014): 1034-1038.). It would be unpredictable how a skilled artisan would be able to make the claimed tomato crop plant if the accession “LA0716" is used according to the claims, i.e., following the SEQ ID NO: 1 to the QTL.
Thus, in view of the unpredictability associated with plant breeding, the lack of enabling guidance regarding the structural identity (i.e., nucleotide sequence) of the deterministic elements within the QTL, and inaccessibility of the essential genetic material (i.e., “Lost Accession; LA5240”), the lack of sufficient working examples, and the level of the art at the time of the invention, one of ordinary skill in the art must rely on undue trial and error experimentation to make the invention within the full scope of these Claims.
For at least this reason, the Specification does not teach a person with skill in the art how to make and/or use the subject matter within the full scope of these Claims.
Furthermore, it appears the invention appears to rely on the seed of a plant, namely, S. pennellii “Lost Accession LA5240”. Since the seed, as 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. As disclosed, 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 a seed is not so obtainable or available, the requirements of 35 U.S.C. 112 may be satisfied by a deposit thereof. If Applicant decide to perfect a deposit, the following requirements should be satisfied:
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.
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 indicated that Applicant intends to perfect the deposit in accordance with 37 CFR 1.801-1.809. However, since 37 CFR 1.801-1.809 addresses procedural matters concerning biological deposits and not substantive issues, both Budapest Treaty and non-Budapest Treaty deposits must provide assurances that:
(1) Access to deposited material will be available, during pendency of a patent application making reference to it, to anyone determined by the Director to be entitled to access under 37 CFR 1.14 and 35U.S.C.122 (see In re Lundak, 227 USPQ 90, 94-95 (Fed. Cir. 1985) (citing 35 U.S.C. 114)); and
(2) 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.
According, Applicant needs to provide a signed statement providing the assurance above as required to overcome this rejection. Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Conclusion
No claims are allowed.
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.
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WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663
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