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 .
Applicant’s amendment
Examiner note: two claim sets were filed on 4/12/2023, one a copy labelled WO2022/079267 and one with amendments considered a preliminary amendment.
Applicant’s preliminary amendment filed 4/12/2023 has been received and entered. Claims 1-17 have been amended and claim 18 has been indicated to be cancelled.
Priority
This application filed 4/12/2023 is a 371 national stage filing of PCT/EP2021/078990 filed 10/15/2021 and claims benefit to foreign application EP20202026.9 filed 10/15/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Additionally, upon review of the ADS and filing receipt, acknowledgment is made of applicant's claim for priority under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) based upon an application filed in EP on 10/15/2020. The claim for priority cannot be based on said application because the subsequent nonprovisional or international application designating the United States was filed more than twelve months thereafter and no petition under 37 CFR 1.55 or request under PCT Rule 26bis.3 to restore the right of priority has been granted.
Applicant may wish to file a petition under 37 CFR 1.55(c) to restore the right of priority if the subsequent application was filed within two months from the expiration of the twelve-month period and the delay was unintentional. A petition to restore the right of priority must include: (1) the priority claim under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) in an application data sheet, identifying the foreign application to which priority is claimed, by specifying the application number, country (or intellectual property authority), day, month, and year of its filing (unless previously submitted); (2) the petition fee set forth in 37 CFR 1.17(m)(3); and (3) a statement that the delay in filing the subsequent application within the twelve-month period was unintentional. The petition to restore the right of priority must be filed in the subsequent application, or in the earliest nonprovisional application claiming benefit under 35 U.S.C. 120, 121, 365(c), or 386(c) to the subsequent application, if such subsequent application is not a nonprovisional application. The Director may require additional information where there is a question whether the delay was unintentional. The petition should be addressed to: Mail Stop Petition, Commissioner for Patents, P.O. Box 1450, Alexandria, Virginia 22313-1450.
Information Disclosure Statement
The two information disclosure statements (IDS) submitted on 4/12/2023 and 12/3/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-13, 15-17 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. In claim 1 each of the steps is followed by a parenthetical (S10), (S20) or (S30) which are undefined in the claim and it is unclear how these are to be interpreted and how the affect the metes and bounds of the claims. Dependent claim 7 recites (S50) and has the same issue. Other dependent claims fail to provide definition or clarify the issue and the claims are included as they depend on claim 1.
Claim 4 recites the limitation "the first computer-implemented". There is insufficient antecedent basis for this limitation in the claim. Claim 1 has been amended to delete computer implementation, so while comprised it is not clear which steps or what other elements are practiced using a computer.
Claims 12-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The claims provide a use without any active steps, or alternatively as a product fail to provide any characteristics that clearly define the metes and bounds.
Claims 1-17 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. Specifically, the preamble of the independent claims 1 and 14 provide for a preamble of ‘determining plant data and/or issuing treatment instructions for hybrid breeding’ however the step that follow fail to provide for either of these generically. The final steps appear to be directed to analyzing flowering phases of plants, but it is unclear how this is related to hybrid breeding or what model is first provides, and overall the claims appear vague and incomplete as to what the claims encompass based on the preamble and particular steps of the method itself set forth in the claims.
More clearly providing additional steps that make clear the model, type of input data and how if and when flowering phase would be determined how it is applied as stated in the preamble would address the basis of the rejection.
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 12-13 are rejected under 35 U.S.C. 101 as failing to claim a statutory class of invention. The claim purports to claim a new use of a growth model and geographical location data, but fails to define any active, positive steps delimiting how this use is actually practiced. See Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967).
More clearly providing active steps for the ‘use’ or provide a product with features or functions would address the basis of the rejection.
Claims 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim analysis
Claim 1 has been amended and is generally directed to providing a model to analyze the growth and pollination phase of female and male plants. More specifically, the claim 1 have been amended are directed to a method (deleting a computer implemented method so broadly provides for any field and any model type) with five steps for providing growth data for male and female plants, inputting the data into a model and providing pollination phase data. Dependent claims provide for other consideration such as geography/location for breeding, and claim 4 for computer implementation and the use of machine learning, and the plants being studies have different pollination phases for any reason. Claims 12 and 13 are use claims but refer to claim 1 for a model or data being used. Claim 14 provides for a system with steps implemented consistent with the method of claim 1, claim 15 provides for a CRM with the instructions provided by claim 7, and claims 16 and 17 refer to claim 7 for using agricultural equipment for treatment based on the instructions produced in claim 7 (which depends on claim 1).
For step 1 of the 101 analysis, the claims are found to be directed to a statutory category of a method and products.
For step 2A of the 101 analysis, the judicial exception of the claims are the steps of accessing growth data and more specifically flowering phase information for plants and providing what is observed. Dependent claims provide for evaluating other location and growth related data and further instructions to use the observed analysis for breeding. The system provides a computer to do the analysis and use claims for agricultural equipment that can be used in breeding (but broadly can be used for any purpose as the analysis data fails to limit the structure of the equipment and maybe only limits when it is used). The steps of claim 1 provide broadly for any model and analyzing growth data, and more specifically flowering phases of male and female plants. In light of the specification and art of record, not all male/female plants flower at the same time, and thus for some knowing the phase differences may allow for using the information for planting or more generally setting expectations of when breeding can be performed between two plants that flower at different times in their life cycle. The judicial exception is a set of instructions for analysis of growth and flowering data and providing instructions to use it for breeding or for using equipment. The judicial exception appears to fall into the category of a Mental Processes, that is concepts performed in the human mind (including an observation, evaluation, judgment, opinion) and into mathematical analysis to the extent that most machine learning applies statistical analysis to data. The breadth of “providing” and “inputting” encompasses non-transformative visual assessment of an individual for given growth, coupled with prior knowledge or intent of the correlation of said information for application to breeding plants. This breadth does not impose a meaningful limit on the claim scope, such that all others are not precluded from observing and using the natural principle of when plants flower, and providing a table, ie. a model, which represents the data for further use or in the form of instructions for breeding or using equipment. Although dependent claims recite using a computer, the courts have also identified limitations that did not integrate a judicial exception into a practical application; for example, merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f) are not patent eligible. The recited analysis and intended breeding crosses are together reasonably interpreted as mere data gathering and analysis. Computing, constructing datasets and using statistical models (machine learning) was well understood, conventional, and routinely performed in the art at the time the application was filed. The claims appear to fall into the category of Mathematical Concepts, as it applies the use of statistics and mathematical relationships in analyzing probabilities, and also into the category of mental processes, as concepts performed in the human mind (including an observation, evaluation, judgment, opinion) because there is no apparent complexity to or amount of data that is collected and analyzed as presently claimed.
Recent guidance from the office requires that the judicial exception be evaluated under a second prong to determine whether the judicial exception is practically applied. In the instant case, the claims do not have an additional element beyond instructions or using instructions. This judicial exception requires steps recited at high level of generality and are only stored on a non-transitory or implemented using a computer system, and is not found to be a practical application of the judicial exception as broadly set forth.
For step 2B of the 101 analysis, each of the independent claims recites additional elements and are found to be the steps of obtaining sequence data. As such, the claims do not provide for any additional element to consider under step 2B. It is noted that in explaining the Alice framework, the Court wrote that "[i]n cases involving software innovations, [the step one] inquiry often turns on whether the claims focus on the specific asserted improvement in computer capabilities or, instead, on a process that qualifies as an abstract idea for which computers are invoked merely as a tool." The Court further noted that "[s]ince Alice, we have found software inventions to be patent-eligible where they have made non-abstract improvements to existing technological processes and computer technology." Moreover, these improvements must be specific -- "[a]n improved result, without more stated in the claim, is not enough to confer eligibility to an otherwise abstract idea . . . [t]o be patent-eligible, the claims must recite a specific means or method that solves a problem in an existing technological process.” As indicated in the summary of the judicial exception above and in view of the teachings of the specification, the steps are drawn to analysis of sequence data. While the instruction are stored on a medium as for the CRM and could be implemented on a system such as a computer, together the steps do not appear to result in significantly more than a means to compare growth data. The judicial exception of the method as claimed can be performed by hand and in light of the previous claims to a computer medium and in light of the teaching of the specification on a computer. In review of the instant specification the methods do not appear to require a special type of processor and can be performed on a general purpose computer. Based upon an analysis with respect to the claim as a whole, claims 1-17 do not recite something significantly different than a judicial exception. Dependent claims set forth additional steps which are more specifically define the considerations and steps of calculating, and comparing, and do not add additional elements which result in significantly more to the claimed method for the analysis.
To summarize, Step 1 requires a determination of whether the claims are directed to a process, machine, manufacture, or a composition of matter. In the instant case the Step 1 requirement is satisfied as the claims are directed towards a conventional process of obtaining and analyzing data/information. The Step 2 analysis is a two-part analysis, Step 2A and Step 2B, with the first part Step 2A requiring a determination of whether the claims are directed towards a judicial exception, i.e. a law of nature, natural phenomenon, or an abstract idea. In the instant case, the claims comprise steps of comparing sequences and is considered the judicial exception. Therefore, the result of Step 2A analysis is that the claims are directed towards a judicial exception, i.e. an abstract idea. The second part, Step 2B of the two step analysis is to determine whether any element or combination of elements, in the claim is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception. No additional steps are recited in the instantly claimed invention that would amount to significantly more than the judicial exception. Without additional limitations, a process that employs mathematical algorithms (machine learning) to manipulate existing information to generate additional information is not patent eligible. In other words, patenting abstract idea (designing probes to a target sequence) cannot be circumvented by attempting to limit the use to a particular technological environment or purpose and desired result.
One way to overcome a rejection for non-patent-eligible subject matter is to persuasively argue that the claimed subject matter is not directed to a judicial exception. Another way for the applicants to overcome the rejection is to persuasively argue that the claims contain elements in addition to the judicial exception that either individually or as an ordered combination are not well understood, routine, or conventional. Another way for the applicants to overcome the rejection is to persuasively argue that the claims as a whole result in an improvement to a technology. Persuasive evidence for an improvement to a technology could be a comparison of results of the claimed subject matter with results of the prior art, or arguments based on scientific reasoning that the claimed subject matter inherently results an improvement over the prior art. The applicants should show why the claims require the improvement in all embodiments.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Birchler et al., Gao et al. and Perez-Prat et al.
Claim 1 provides steps to use a model to analyze the growth and pollination phase of female and male plants. More specifically, the claim 1 provides a method with five steps for providing growth data for male and female plants, inputting the data into a model and providing pollination phase data. Dependent claims provide for other consideration such as geography/location for breeding, and claim 4 for computer implementation and the use of machine learning when doing the analysis, and the data about the plants being studied have different pollination phases for any reason. Claims 12 and 13 are use claims but refer to claim 1 for a model or data being used. Claim 14 provides for a system with steps implemented consistent with the method of claim 1, claim 15 provides for a CRM with the instructions provided by claim 7, and claims 16 and 17 refer to claim 7 for using agricultural equipment for treatment based on the instructions produced in claim 7 (which depends on claim 1).
At the time, breeding plants in particular to provide hybrid vigor was well known. For example, Birchler et al. provided a detailed analysis of the genetics involved in unraveling the genetic basis of hybrid vigor. Birchler et al. teach that the study of hybrid vigor and in breeding depression traces back to Charles Darwin, who was the first scientist to examine the phenomenon in a systematic manner, and provide a more detailed analysis of plant breeding and crosses that resulted in hybrid vigor. Birchler et al. provide for steps of obtaining data and analyzing data in attempts to find crosses that result in the increase in stature, biomass, and fertility that characterizes the progeny of crosses between diverse parents such that the F1 is superior to the better of the two parents. Bircherler et al. do not specifically investigate flowering, however it is noted that not all male and female plants demonstrate a difference in flowering phases, however such plants were known as discussed in Gao et al. Moreover, Gao et al. provide detailed guidance on flowering stages and various factors that affect the phases as they relate to fruit and see growth. For example, it is taught that ‘changes in the proportions of male and female flowers in monoecious plants in response to external environmental conditions are directly related to the reproductive fitness of plants. The monoecious cucumber (Cucumber sativus) plant was used in this study to assess the responses of sex differentiation and the breeding process to nutrient supply and the degree of artificial pollination using pollen solutions of different concentrations.’ Together, both provide that breeding plants for desired traits were known and that various growth conditions would affect the growth of male and female plants. Perez-Prat et al. is provided as additional evidence of breeding techniques and the level of skill in the art for hybrid seed production and possible challenges of propagating male plants. More specifically, Perez-Prat provides that the introduction of hybrid crop varieties has enabled spectacular increases in productivity owing to hybrid vigor and increased uniformity as motivation to investigate and use breeding. However, to produce hybrid seeds, a pollination control system is required to prevent unwanted self-pollination. In crop species with hermaphrodite flowers, this can be a major challenge. Over the past decade, new pollination control systems have been developed with the aid of genetic engineering, mainly based on the generation of nuclear-encoded male sterility. The successful application of these systems for large-scale hybrid seed production depends on whether the male-sterile female parent line can be multiplied efficiently and economically. In spite of its relevance, the propagation of the male-sterile line has often been overlooked in the development of pollination control systems.
Given that hybrid breeding was well known for obtaining plants of a desired quality or possessing a specific trait, and in particular certain plants such as some cucumbers flower at different times, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was made to know and provide conditions for breeding male and female plants. One could change planting times, nutrition or any parameter such that crossing male and female plants with different growth cycles, in particular flowering would be modified to optimize the processing. The use of the necessary agricultural equipment would be necessary and obvious, as well as tables or more complex data sets using a computer to analyze data when the plants are not well characterized. One having ordinary skill in the art would have been motivated to provide as much growth data about male and female plants for analysis and provide instructions and guidance based on what is observed to provide efficient breeding protocols to any variety of plants. Given the high level of skill and knowledge in the art, as well as the successful examples provided, there would have been a reasonable expectation of success to analyze data and apply what is observed to breeding protocols.
Thus, the claimed invention as a whole was clearly prima facie obvious.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joseph T Woitach whose telephone number is (571)272-0739. The examiner can normally be reached Mon-Fri; 8:00-4:00.
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/Joseph Woitach/Primary Examiner, Art Unit 1687
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