DETAILED CORRESPONDENCE
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 .
Status of the Claims
The status of the claims is as follows:
Claims 10-14 filed 11 April 2024 are pending.
Claims 10-14 have been hereby examined.
Priority
The present application filed on 11 April 2024 is a Continuation of 17/403,238 which claims the benefit of U.S. provisional application number 63/065579 filed on 14 August 2020.
Claim Objections
Claim 12 is objected to because of the following informalities:
Part “g)”of claim 12 states “after the at least 4 months of storage, (i) planting one or more of the seeds of (f).” This recitation is confusing because it is unclear if there is a missing step “(h)”, if it is an attempt to add an additional limitation to the method of “preparing Annatto seeds for planting, or some other action not envisioned by the Examiner. It is suggested that the Applicant amended 12 g) to make the intention clear.
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.
Claim 12 and dependent claims 13 and 14 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter that 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 claims were amended or added using limitations that introduce NEW MATTER.
Neither the instant specification nor the originally filed claims appear to provide support for the phrase/concept “an airtight container”. There are a total of 5 recitations of “container” in the originally filed specification and 0 recitations of “airtight” or “airtight container”. The first recitation of “container” in [0002], states that the present disclosure provides a method of preserving plant pigments and enhancing seed germination of a plant part in container having a low oxygen environment, wherein the low oxygen environment comprises at least one oxygen-scavenging agent. This recitation is merely that the container itself has a low oxygen environment but does not limit the container to an airtight container. [0005] state that the container may be formed by a rigid or flexible polymer packaging material but does not limit the material to any non-porous material or a material that would prohibit the exchange of gases from the external environment (i.e. airtight). The 3rd recitation of container, also in [0005], discusses the oxygen-scavenging agent located inside the container, but does not limit the container to an airtight container. [0028] discusses the importance of drying the seeds before storing and the factors that influence safe moisture content. Applicants state for example, under ordinary storage conditions for 12-18 months, drying to MC 10% is sufficient for cereals, while for storage in sealed containers, drying to MC 5-8% may be necessary. them in a sealed container. This is merely an example of moisture content under different storage conditions and not a limitation of an airtight container. [0030] provides a discussion on relative humidity and states “in sealed storage, seed moisture content determines the relative humidity of the environment in the containers” and again does not specify that the containers themselves are airtight and prohibit gas or molecule exchange.
Furthermore, the originally filed claims do not exclude the use of containers that are permeable to gas, ion or molecule exchange. Claim 1 (filed 16 August 20221), amended claim 1 (filed 30 January 2023) and claim 10 (filed 11 April 2024) do not limit the container to an airtight container. There are limitations stating that the only component within the container that can influence the relative humidity of the environment in the container is the seed or more specifically the Annatto seed. This limitation does not preclude external elements from influencing the environment of the container as would be the case with an airtight container.
Thus, such a phrase constitutes NEW MATTER. In response to this rejection, Applicant is required to point to support for the phrase or to cancel the new matter.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Cichello (2015. Oxygen absorbers in food preservation: a review. J Food Sci Technol. 52: 1889-1895), Raddatz-Mota et al (2017. Achiote (Bixa Orellana L.): a natural source of pigment and vitamin E. J Food Sci Technol. 54: 1729-1741) and Poornima et al (2012. Germination studies in an important natural food dye yielding plant Bixa Orellana. Internation Journal of Innovations in Bio-Sciences. Vol2: 48-50).
The claims are broadly drawn to a method of pre-treating Annatto seed for bixin harvest and a method of preparing Annatto seeds for planting comprising harvesting viable Annatto seeds, drying the viable sed to between 4% and 10% moisture content; adding the seeds to a container (or an airtight container) comprising at least one oxygen scavenging agent; sealing the container; storing the sealed container in an environment wherein the temperature is less than room temperature for at least 4 months; and harvesting or planting one or more of the seeds, respectively, wherein the seeds are the only component within the container that can influence the relative humidity of the environment in the container. The claims are further drawn to flushing the container with a nitrogen gas prior to sealing the container. The method of preparing Annatto seeds for planting further comprises planting one or more of the seeds after at least 4 months of storage and planting the seeds and recording a 70% greater germination rate for seeds stored for 4 months and a 50% or greater germination rate for seeds stored for approximately one year.
Claim Interpretation
Claim 14 is merely stating an intended use of the resulting seeds obtained using the method of preparing Annatto seeds for planting and does not impose any limitations on the claimed methodology. The claim is drawn to planting the seeds that were prepared using the claimed methods and recording a 70% greater germination rate for seeds stored for 4 months and a 50% or greater germination rate for seeds stored for approximately one year. That means, a practitioner of this method step could plant the seeds and ONLY record the data showing a 70% or 50% greater germination rate under the varying storage time. This claim does not require that all seeds that were obtained by the methodology would result in a 70% or greater germination rate for seeds stored for 4 months or a 50% or greater germination rate for seeds stored for approximately one year.
Poornima et al teach that mature seeds of Bixa orellana were collected from trees (which reads on harvesting viable Annatto seeds) [page 48, right column, para. 2] and stored in air tight plastic wares (which reads on a container or an airtight container and sealing the container) at three different conditions (room temperature, 10ºC and 0ºC (which reads on storing the sealed container in an environment wherein the temperature is less than room temperature) [page 49, left column, para. 1]. The seed moisture content was determined for 2 accessions of Bixa orellana [page 49, left column, para. 2]. Poornima et al found that seeds could be dried to 5.2 to 8.05% moisture level (which reads on drying the seeds to between 4% and 10% moisture content) and still retain germinability up to 72% for more than two years (which reads of for at least 4 months). Storage at low temperature of 0ºC did not kill the seeds and retained viability for more than 2 years. Their storage life has been extended over two years without any kind of treatment indicating for sure that the seeds are not recalcitrant [para. bridging page 49-50].
Therefore, after considering Poornima et al as a whole, one of ordinary skill in the art would understand that different methodologies of Annatto seed preservation were well known in the art and commonly practiced by the skilled artisan. One would also understand that drying the seeds to about 4% and 10% was commonly practiced and known to produce seeds that were viable and able to be used for later germination. Poornima et al also teach that drying seeds to 5.2 to 8.05% moisture level (which falls within the range of between 4% and 10% moisture content) enable the seeds to retain germinability up to 72% for more than two years. Furthermore, temperatures at or below room temperature (0ºC) did not kill the seeds and retained viability for more than 2 years.
Poornima et al do not teach a container comprising at least one oxygen scavenging agent or flushing the container with a nitrogen gas prior to sealing the container.
Cichello teach that oxygen absorbers have an important role in the removal of dissolved oxygen, preserving the colour, texture and aroma of different food products, and importantly inhibition of food spoilage microbes [abstract]. Cichello teach that various effects of oxygen on preserved foods includes, darkening or browning of fruit/vegetables, deterioration of flavor, loss of vitamin C and acceleration of respiration in fruits and vegetable-based foods [page 1889, rt. Column, para. 2]. The ferrous iron-based oxygen scavengers are most widely used in the preservation of packaged foods [page 1890, rt. Column, last para.]. The material and packaging of the OxySorb™ are safe to come into contact with food items [page 1891, rt. column, para. 3]. Oxygen absorbers have successfully impeded the oxidation of β-carotene in dried sweet potato flakes vacuumed sealed with an oxygen absorber and provide the highest level of retention of the pigment β-carotene over a 210 day trial period [page 1892, rt. column, para. 1]. In fruit and vegetable preservation, oxygen absorbers impede macroscopic organisms and also maintain the nutritional status of food such as vitamin levels [page 1892, rt. column, para. 1]. The use of oxygen absorbers with almond kernels provides a 12 month shelf life. Two pouch (which reads on container) types were flushed with N2, in combination with an oxygen absorber which increased the shelf life and decreased the degradation of colour [p. 1982, rt. column, last para.]. Cichello teach that it appears that oxygen absorbers are crucial for packaging of nuts and seeds to protect against degradation of fatty acid composition [page 1893, lf. Column, para. 1]. Cichello teach that oxygen absorbers inhibit the formation of aerobic pathogens, spoilage organisms and mold, delay non-enzymatic discoloration and darkening of fruits and vegetables, extend the shelf-life of nutraceutical and pharmaceutical products, inhibit oxidation and condensation of berries, and minimize the need for some additives/preservatives.
Therefore, after considering Cichello as a whole, one of ordinary skill in the art would understand the importance of oxygen absorbers (oxygen-scavenging agents) in food preservation. One would also understand that the presence of oxygen absorbers increased shelf-life, decrease degradation of color and inhibit pathogens. One would also understand that a combination of N2 flushing and oxygen absorbers are used in the food industry, especially in preserving seeds and nuts. This combination of N2 flushing and oxygen absorbers in seeds and nuts increased the shelf-life and preserved the color.
Raddatz-Mota et al teach Achiote (Bixa orellana L.) contains bixin and has a wide range of uses including annatto extracts, cosmetics, nutraceutical, medicinal and colorant [entire document]. Annatto extracts are widely used in the food industry, mainly in dairy and other food products such as poultry, fish, surimi (imitation of crab meat), bakery, breakfast cereals, several desserts, jam and jellies, maraschino cherries, cream and icing for cakes, sauces, condiments, candies and beverages such as aperitifs, soft-drinks and juices [para. Bridging pages 1734-1735]. The medicinal applications in folk medicines include treating diarrhea, asthma, burns, bleed, dysentery, gonorrhea, anti-nausea, obesity, stomach problems, hepatitis, snakebites, antitumoral, antiseptic, antibacterial, etc. [para bridging page 1739-1740; page 1740, lf. Column, para. 2 and 3].
Therefore, after considering Raddatz-Mota. et al as a whole, one of ordinary skill in the art would understand that Bixa orellana and harvested bixin, are a widely used compound that has a long history as a medicinal and food colorant plant product.
It would have been obvious, at the time the instant application was filed, to combine the methodologies as taught by Cichello and Poornima et al to pre-treat and prepare the Annatto seeds for harvesting and planting as taught by Raddatz-Mota et al and Poornima et al. The pigments, plant parts and seeds of Annatto are widely utilized in food, pharmaceutical, medicinal and nutraceutical industries as taught by Raddatz-Mota et al and Poornima et al. Cichello teach the importance of oxygen absorbers (oxygen-scavenging agents) in food preservation and disclose that the presence of oxygen absorbers increased shelf-life, decrease degradation of color and inhibit pathogens. Furthermore, Cichello teach that the combination of N2 flushing and oxygen absorbers in seeds and nuts increased the shelf-life and preserved the color. Poornima et al teach that drying seeds to 5.2 to 8.05% moisture level (which falls within the range of between 4% and 10% moisture content) enable the seeds to retain germinability up to 72% for more than two years. Furthermore, temperatures at or below room temperature (0ºC) did not kill the seeds and retained viability for more than 2 years. One would have been motivated to combine the preservation methods as taught by Cichello and Poornima et al to preserve plant parts and seeds as taught by Raddatz-Mota and Poornima et al to preserve, extend the shelf-life and retain the coloration of the highly valued plant parts, pigments and seeds. One would have been motivated to utilize the preservation methods as taught by Cichello and Poornima et al to preserve plant parts as taught by Raddatz-Mota and Poornima et al to preserve, extend the shelf-life and retain the coloration of the highly valued plant parts and pigments. One would have reasonable expectation of success given that the individual methodologies were successfully used to preserve other plants, plant parts and seeds while also retaining the coloration, extending shelf-life, sustain germination and decreasing microbial growth.
Conclusion
Claims 10-14 are rejected.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN M REDDEN whose telephone number is (571)270-0298. The examiner can normally be reached 730-6 Monday-Thursday.
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/KAREN M REDDEN/Primary Examiner, Art Unit 1661