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 .
Response to Amendment
The amendment filed 08/11/2026 has been entered. Claims 14-19, 21-22, and 25-32 remain pending in the application. Claims 27-31 remain withdrawn. Claims 14-19, 21-22, 25-26 and 32 remain rejected.
Claim Rejections - 35 USC § 103
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.
Claim(s) 14-19, 21-22, 25, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boursier (US 20110311599 A1) in view of Segall (US 20140017379 A1), Senecot (US 20220400700 A1), Chéreau et. al. (Combination of existing and alternative technologies to promote oilseeds and pulses proteins in food applications), Fenioux (FR 2860396 A1), Mount Sinai (Lysine), Segall (US 20140093626 A1), and Team MGN (How Seasonal Variations In Cow’s Milk Affects Whey Protein).
Regarding claim 14, Boursier teaches (Paragraph 0001, 0037, 0045, 0061) a granulated powder containing at least one protein of vegetable origin and at least one fiber of vegetable origin (i.e. consisting of), wherein the vegetable protein is a protein derived from the family of cereals, oleaginous plants, leguminous plants, tuberous plants, algae and microalgae, wherein preferably, said leguminous plant protein is pea. Boursier further teaches (Paragraph 0072, 0073, 0075) the pea proteins used are in the form of a composition of pea protein (soluble fraction) having: a soluble protein content of between 20% and 99%, wherein, preferably, use is made of a protein having a high soluble protein content of between 45% and 90%, and wherein embodiments of the pea protein are mainly in native globular form, globulins, or albumins (which includes embodiments containing albumins but not globulins). In addition, Boursier teaches (Paragraph 0110) said powder comprises pea proteins and at least one insoluble vegetable fiber, and preferably one leguminous plant fiber and even more preferably one pea fiber (pulp). Also, Boursier teaches (Paragraph 0037) the granulated powder has a dry matter content (solids content) of greater than 80%, preferably greater than 85%, and even more preferably greater than 90%. Additionally, Boursier teaches (Paragraph 0021-0023) providing vegetable proteins as a replacement for animal proteins, while at the same time making it possible to retain a nutritional value which is at least similar, or even improved, wherein the product will have an equivalent nutritional value: if it contains an amount of proteins, mineral salts, and vitamins equivalent to that present in the products of animal origin. Thus, Boursier does not explicitly state that the product contains salts but at least indicates that salts are desirable in the product.
Boursier is silent on the soluble fraction being the residual aqueous fraction obtained after the extraction of the starch, pulps and proteins of globulin type derived from seeds of leguminous plants, using a wet fractionation process, wherein said soluble fraction includes sugars and salts. Boursier is further silent on the product being obtainable by a process consisting of: i) pre-treating leguminous plant seeds; ii) wet-separating constituents of the leguminous plant seeds into four fractions comprising a starch fraction, a pulp fraction, a globulin-type protein fraction, and a soluble fraction; iii) mixing the pulp fraction and the soluble fraction separated in step ii); and iv) drying the mixture obtained in step iii).
However, the Examiner notes that, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (See MPEP 2113 I). Furthermore, stating that the claimed product is “obtainable” by a process does not mean that the product is obtained by the recited process, but simply that it can be obtained by the recited process.
In addition, Boursier is silent on said product's lysine content being between 3% and 10% by weight of total protein content. Furthermore, Boursier is silent on said product's component L being greater than 30; said product's component a is less than 20, and said product's component b being greater than 25.
Segall (US 20140017379 A1) teaches (Paragraph 0002, 0046) pH-adjusted pulse protein products, wherein pulses to which the invention may be applied include, but are not limited to lentils, chickpeas, dry peas and dry beans. Segall (US 20140017379 A1) further teaches (Paragraph 0005-0011) extracting a pulse protein source with an aqueous calcium salt solution, preferably an aqueous calcium chloride solution, to cause solubilization of pulse protein from the protein source and to form an aqueous pulse protein solution; separating the aqueous pulse protein solution from residual pulse protein source; adjusting the pH of the aqueous pulse protein solution to a pH of about 1.5 to about 4.4, preferably about 2 to about 4, to produce an acidified pulse protein solution; optionally clarifying the acidified pulse protein solution if it is not already clear; optionally concentrating the acidified aqueous pulse protein solution while maintaining the ionic strength substantially constant by a selective membrane technique. Segall (US 20140017379 A1) further teaches (Paragraph 0090) in the procedures in which precipitated solids are collected and dried, the remaining soluble protein fraction may also be processed to form a pulse protein product, wherein, in some embodiments, the soluble fraction may be dried directly.
Additionally, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (See MPEP 2113 I).In this case, the product is a dried mixture of only a pulp fraction with a soluble fraction from leguminous plants, and which soluble fraction includes albumin, sugars and salts.
Furthermore, it is known in the art, for example from Senecot (US 20220400700 A1) that (Paragraph 0046, 0049) the soluble fraction of separated pea protein contains albumins, sugars and salts (which would be retained when directly drying as disclosed by Segall (US 20140017379 A1)).
It would have been obvious to one of ordinary skill in the art to modify Boursier to provide a soluble fraction (which is known in the art to include albumins, salts, and sugars) in view of Segall (US 20140017379 A1) and Senecot, since each of Boursier, Segall (US 20140017379 A1), and Senecot is directed to a method of preparing products containing dry concentrates of pea proteins, including albumins, since providing a soluble fraction is known in the art as shown by Segall (US 20140017379 A1), since the soluble fraction of pea protein is known to include albumins, sugar, and salt as shown by Senecot, since albumins are richer in sulphur amino acids and lysine while globulins are characterized by a higher proportion of aspartic acid, glutamic acid and their corresponding amides on the one hand, and on the other, upper arginine content (Chéreau et. al., Section 2.4), thus a soluble fraction with a higher albumin content can be used to control or increase the amount of lysine and sulphur amino acids provided to the consumer, which will be beneficial to consumers in need of additional lysine, and sulphur amino acids, since, alternatively, the soluble fraction can be provided to reduce the amount glutamic acid, aspartic acid, etc., provided to consumers of pea protein, which can be beneficial to consumers who need a reduced intake of such components, since salt and sugar can provide additional flavor and nutrition to the composition, since removal of salt and sugar would require extra time and processing expenses, since using only the soluble fraction of the protein would allow the composition to be added to be combined with water or other liquids to make a beverage or consumable product with all the components dissolved and no clumping or aggregation of ingredients.
Fenioux teaches (Paragraph 0008, 0011) a food product comprising a carbohydrate component and at least one legume protein isolate, wherein the legume protein isolate is chosen from alfalfa, clover, bean, pea and lupine protein isolates, and wherein the legume protein isolate contains at least 4.4% by weight of lysine.
Chéreau et. al. teaches (Section 2.4) albumins are richer in lysine compared to globulins.
Mount Sinai teaches that lysine is an essential amino acid that is necessary for human health, but must be acquired from food or supplements. Mount Sinai further teaches that insufficient lysine intake can result in symptoms including fatigue, nausea, and dizziness. Also, Mount Sinai teaches Lysine helps the body absorb calcium and reduces the amount of calcium that is lost in urine. In addition, Mount Sinai teaches studies suggest lysine helps muscle tissue recover after stress. Furthermore, Mount Sinai teaches that excessive doses of lysine can cause gallstones and renal dysfunction.
It would have been obvious to one of ordinary skill in the art to configure the product of Boursier to have a lysine content between 3% and 10% (such as by adjusting the relative amounts of protein and fiber, adjusting the amount of albumin, manipulating the production process of the protein to control the resulting lysine content, adding additional lysine, etc.) in view of Fenioux since both are directed to products containing legume protein isolates, including pea protein isolates, since a pea protein isolate with a lysine content of between 3% and 10% by weight of its total protein content, is known in the art as shown by Fenioux, since lysine is an essential amino acid that is necessary for human health, but must be acquired from food or supplements (Mount Sinai), since insufficient lysine intake can result in symptoms including fatigue, nausea, and dizziness (Mount Sinai), since lysine helps the body absorb calcium and reduces the amount of calcium that is lost in urine (Mount Sinai), since studies suggest lysine helps muscle tissue recover after stress (Mount Sinai), and since excessive doses of lysine can cause gallstones and renal dysfunction (Mount Sinai).
Furthermore, the claimed lysine content would have been used during the course of normal experimentation and optimization procedures in the method of Boursier (such as by adjusting the relative amounts of protein and fiber, adjusting the amount of albumin (where albumins are richer in lysine compared to globulins (Chéreau et. al., Section 2.4)), manipulating the production process of the protein to control the resulting lysine content, adding additional lysine, etc.) based upon factors such as the intended nutritional effect of the powder (where lysine can improve calcium retention and muscle recovery, but excess lysine can cause issues including gallstones), the consumers diet (where some consumers may have diets that have too little or too much lysine intake), the length or heat of drying to prepare the powder, etc. Furthermore, the Applicant has neither demonstrated the criticality nor identified any unique or unexpected benefit of the claimed lysine content that would render it non-obvious.
Segall (US 20140093626 A1) teaches (Paragraph 0016, 0044) a pulse protein product having a pulse protein content of at least 60 wt. %, wherein pulses to which the invention may be applied include lentils, chickpeas, dry peas and dry beans. Segall (US 20140093626 A1) further teaches (Paragraph 0086; Table 2) an exemplary embodiment, wherein a pea protein isolate in dry powder form has an L* values of 85.74 (greater than 30) and a* values of 3.27 (less than 20).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the product of Boursier to have an L* value greater than 30 and an a* value less than 20 (such as by adjusting the relative proportions of the soluble fraction and pulp, controlling or changing the drying technique, using a different type of pea, etc.) in view of Segall (US 20140093626 A1) since both are directed to powdered products containing pea protein, since a powdered product containing pea protein with an L* value greater than 30 and an a* value less than 20 is known in the art as shown by Segall (US 20140093626 A1), since a higher L* value corresponds to a lighter coloring that will give the product the appearance of being, undegraded, unburnt, and/or free from impurities that will be more visually appealing and desirable for the consumer, since a lighter coloring will satisfy consumer expectations by resembling conventional animal based protein powders that are lighter in color, since a powder with a lighter coloring can be combined with other ingredients without darkening the end composition in a way that would adversely affect the appearance, since a lower a* value corresponds to a less red, more neutral coloring that may more be more visually appealing and desirable for the consumer, since a more neutral coloration would be more desirable for consumers who desire to add the powder to beverages, soups, etc. without drastically altering the appearance of the base ingredients, and since an overly red or bright red coloration may make the product appear artificial or unhealthy to the consumer.
Furthermore, all of the claimed ranges for the L* value, the a* value, and the b* value would have been used during the course of normal experimentation and optimization procedures (such as by adjusting the relative proportions of the soluble fraction and pulp, controlling or changing the drying technique, processing a different type of pea, etc.) in the production of the product of Boursier, as modified above, based upon factors such as consumer expectations (where other protein products such as whey are known to have a yellow coloration (higher b* value) (Team MGN, Paragraph 9)), consumer preferences in color (where some consumers prefer foods with a specific coloration), the intended use of protein powder (where the powder may be intended to be combined with other ingredients to make a resulting product which is intended to have a specific coloration such that that powder’s color should be adjusted to match to coloration), the desired proportions of the soluble fraction and pulp, the type or legume or pea species used, etc. Furthermore, the Applicant has neither demonstrated the criticality nor identified any unique or unexpected benefit of the claimed L* value, a* value, or b* value that would render it non-obvious.
Regarding claim 15, Boursier teaches (Paragraph 0037) the granulated powder has a dry matter content (solids content) of greater than 80%, preferably greater than 85%, and even more preferably greater than 90%.
Regarding claim 16, Boursier teaches (Paragraph 0037) the granulated powder has a dry matter content (solids content) of greater than 80%, preferably greater than 85%, and even more preferably greater than 90%. Boursier further teaches (Paragraph 0239, 0255-0257) an exemplary embodiment, wherein a granulated powder containing pea proteins has a dry matter content (solids content) of 94.5%.
It would have been obvious to one of ordinary skill in the art to configure the product's solids content to be greater than 94% by weight since such a solids content is already known from an exemplary embodiment of Boursier, since a higher solids content (which necessitates a lower water content) will better preserve the product by reducing the possibly of bacterial or microorganism growth, and since a higher solids content can reduce shipping and transportation costs of the product since water can be added back in if necessary at the final destination of the product or in a food prepared using the product as an ingredient.
Regarding claim 17, Boursier teaches (Paragraph 0072-0075, 0110), as shown above, said powder comprises pea proteins including protein having a high soluble protein content (soluble fraction) and at least one insoluble vegetable fiber, and preferably one leguminous plant fiber and even more preferably one pea fiber (pulp).
Regarding claim 18, Boursier teaches (Paragraph 0164) according to one particular embodiment of the present invention, 90% of the powder has a diameter of less than 1000 µm, preferably less than 500 µm, and even more preferably less than 400 µm, which overlaps with the claimed range of between 50 microns and 3000 microns.
Regarding claim 19, Boursier teaches (Paragraph 0164) according to one particular embodiment of the present invention, 90% of the powder has a diameter of less than 1000 µm, preferably less than 500 µm, and even more preferably less than 400 µm, which overlaps with the claimed range of between 300 microns and 1000 microns.
Regarding claim 21, Boursier is silent on the product’s component L being greater than 40, wherein its coloring is according to the "L*a*b*" technique.
Segall teaches (Paragraph 0016, 0044) a pulse protein product having a pulse protein content of at least 60 wt. %, wherein pulses to which the invention may be applied include lentils, chickpeas, dry peas and dry beans. Segall further teaches (Paragraph 0086; Table 2) an exemplary embodiment, wherein a pea protein isolate in dry powder form has an L* values of 85.74.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the product of Boursier to have an L* value greater than 40 (such as by adjusting the relative proportions of the soluble fraction and pulp, controlling or changing the drying technique, processing a different type of pea, etc.) in view of Segall, since both are directed to powdered products containing pea protein, since a powdered product containing pea protein with an L* value greater than 40 is known in the art as shown by Segall, since a higher L* value corresponds to a lighter coloring that will give the product the appearance of being, undegraded, unburnt, and/or free from impurities that will be more visually appealing and desirable for the consumer, since a lighter coloring will satisfy consumer expectations by resembling conventional animal based protein powders that are lighter in color, and since a powder with a lighter coloring can be combined with other ingredients without darkening the end composition in a way that would adversely affect the appearance.
Furthermore, the claimed L* value would have been used during the course of normal experimentation and optimization procedures (such as by adjusting the relative proportions of the soluble fraction and pulp, controlling or changing the drying technique, using a different type of pea, etc.) in the production of the product of Boursier based upon factors such as consumer expectations (where conventional animal based protein powders are lighter in color), consumer preferences in color (where some consumers prefer foods with a lighter coloration), the intended use of protein powder (where the powder may be combined with other ingredients to make a resulting product which is intended to have a lighter coloration), the desired proportions of the soluble fraction and pulp, etc. Furthermore, the Applicant has neither demonstrated the criticality nor identified any unique or unexpected benefit of the claimed L* value range that would render it non-obvious.
Regarding claim 22, Boursier is silent on the product’s component L being greater than 50, wherein its coloring is according to the "L*a*b*" technique.
Segall teaches (Paragraph 0016, 0044) a pulse protein product having a pulse protein content of at least 60 wt. %, wherein pulses to which the invention may be applied include lentils, chickpeas, dry peas and dry beans. Segall further teaches (Paragraph 0086; Table 2) an exemplary embodiment, wherein a pea protein isolate in dry powder form has an L* values of 85.74.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the product of Boursier to have an L* value greater than 50 (such as by adjusting the relative proportions of the soluble fraction and pulp, controlling or changing the drying technique, processing a different type of pea, etc.) in view of Segall, since both are directed to powdered products containing pea protein, since a powdered product containing pea protein with an L* value greater than 50 is known in the art as shown by Segall, since a higher L* value corresponds to a lighter coloring that will give the product the appearance of being, undegraded, unburnt, and/or free from impurities that will be more visually appealing and desirable for the consumer, since a lighter coloring will satisfy consumer expectations by resembling conventional animal based protein powders that are lighter in color, and since a powder with a lighter coloring can be combined with other ingredients without darkening the end composition in a way that would adversely affect the appearance.
Furthermore, the claimed L* value would have been used during the course of normal experimentation and optimization procedures (such as by adjusting the relative proportions of the soluble fraction and pulp, controlling or changing the drying technique, processing a different type of pea, etc.) in the production of the product of Boursier based upon factors such as consumer expectations (where conventional animal based protein powders are lighter in color), consumer preferences in color (where some consumers prefer foods with a lighter coloration), the intended use of protein powder (where the powder may be combined with other ingredients to make a resulting product which is intended to have a lighter coloration), the desired proportions of the soluble fraction and pulp, etc. Furthermore, the Applicant has neither demonstrated the criticality nor identified any unique or unexpected benefit of the claimed L* value range that would render it non-obvious.
Regarding claim 25, Boursier is silent on the product’s lysine content being between 5% and 8% by weight of its total protein content.
Fenioux teaches (Paragraph 0008, 0011) a food product comprising a carbohydrate component and at least one legume protein isolate, wherein the legume protein isolate is chosen from alfalfa, clover, bean, bean, pea and lupine protein isolates, and wherein the legume protein isolate contains at least 4.4% by weight of lysine (i.e., the lysine content may be higher than 4.4%).
Mount Sinai teaches that lysine is an essential amino acid that is necessary for human health, but must be acquired from food or supplements. Mount Sinai further teaches that insufficient lysine intake can result in symptoms including fatigue, nausea, and dizziness. Also, Mount Sinai teaches Lysine helps the body absorb calcium and reduces the amount of calcium that is lost in urine. In addition, Mount Sinai teaches studies suggest lysine helps muscle tissue recover after stress. Furthermore, Mount Sinai teaches that excessive doses of lysine can cause gallstones and renal dysfunction.
It would have been obvious to one of ordinary skill in the art to configure the product of Boursier to have a lysine content between 5 and 8% (such as by adjusting the relative amounts of protein and fiber, adjusting the amount of albumin (where albumins are richer in lysine compared to globulins (Chéreau et. al., Section 2.4)), manipulating the production process of the protein to control the resulting lysine content, adding additional lysine or an additional source of lysine, etc.) in view of Fenioux and Mount Sinai since both Boursier and Fenioux are directed to products containing legume protein isolates, including pea protein isolates, since a pea protein isolate with a lysine content of at least 4.4% (i.e., the lysine content may be higher than 4.4%) is known in the art as shown by Fenioux, since lysine is an essential amino acid that is necessary for human health, but must be acquired from food or supplements (Mount Sinai), since insufficient lysine intake can result in symptoms including fatigue, nausea, and dizziness (Mount Sinai), since lysine helps the body absorb calcium and reduces the amount of calcium that is lost in urine (Mount Sinai), since studies suggest lysine helps muscle tissue recover after stress (Mount Sinai), and since excessive doses of lysine can cause gallstones and renal dysfunction (Mount Sinai).
Furthermore, the claimed range of the lysine content would have been used during the course of normal experimentation and optimization procedures in the method of Boursier (such as by adjusting the relative amounts of protein and fiber, adjusting the amount of albumin, manipulating the production process of the protein to control the resulting lysine content, adding additional lysine, etc.) based upon factors such as the intended nutritional effect of the powder (where lysine can improve calcium retention and muscle recovery, but excess lysine can cause issues including gallstones), the consumers diet (where some consumers may have diets that have too little or too much lysine intake), the length or heat of drying to prepare the powder, etc. Furthermore, the Applicant has neither demonstrated the criticality nor identified any unique or unexpected benefit of the claimed range of the lysine content that would render it non-obvious.
Regarding claim 32, Boursier teaches (Paragraph 0038) the invention relates to a process for obtaining a granulated powder and to the use thereof in various industrial fields, and more particularly in the food-processing field, where it is used as a functional agent such as an emulsifying, overrun, stabilizing, thickening and/or gelling agent, in particular for totally or partially replacing certain animal proteins in the preparation of food products.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boursier (US 20110311599 A1) in view of Segall (US 20140017379 A1), Senecot (US 20220400700 A1), Chéreau et. al. (Combination of existing and alternative technologies to promote oilseeds and pulses proteins in food applications), Fenioux (FR 2860396 A1), Mount Sinai (Lysine), Segall (US 20140093626 A1), and Team MGN (How Seasonal Variations In Cow’s Milk Affects Whey Protein), and further in view of Barata (US 20190045826 A1).
Regarding claim 26, Boursier is silent on wherein the total digestibility of the product’s organic matter for monogastric animals being greater than 75%.
Barata teaches (Paragraph 0001, 0092, 0107) nutritional formulations comprising a pea protein isolate, for use as a single protein source or as a food supplement, intended for infants, children and/or adults (i.e., humans, which are monogastric animals) wherein the pea protein isolate has a digestibility of between 93.5 and 95% (greater than 75%).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the product of Boursier (such as by adjusting the relative amounts of protein and fiber, the types of peas used for the protein or fiber, etc.) to provide a product with a digestibility greater than 75% for monogastric animals in view of Barata, since both are directed to food products comprising pea protein isolates, since a pea protein isolate with digestibility of its organic matter for monogastric animals being greater than 75% is known in the art as shown by Barata, since a higher digestibility gives the consumer improved uptake of amino acids from the protein, since a higher digestibility yields better nutrition per volume of food, allowing consumers with small appetites to gain necessary nutrients and potentially reducing costs by lowering the volume of food need to provide the necessary amount of nutrition.
Furthermore, the claimed digestibility would have been used during the course of normal experimentation and optimization procedures in the method of Boursier (such as by adjusting the relative amounts of protein and fiber, the types of peas used for the protein or fiber, etc.) based upon factors such as the intended nutritional effect of the powder (a higher digestibility gives the consumer improved uptake of amino acids from the protein), the consumers appetite (where some consumers eat lower volumes of food and, therefore, need to digest more nutrients per volume of food), food costs, the desired proportions of protein and fiber, etc. Furthermore, the Applicant has neither demonstrated the criticality nor identified any unique or unexpected benefit of the claimed digestibility that would render it non-obvious.
Response to Arguments
Applicant’s arguments, see pages 5-10, filed 08/11/2026, with respect to the rejection(s) of claim(s) 14 under 35 USC 103, have been fully considered but are not persuasive.
Regarding the Applicant's argument that the present invention extracts the globulins from the soluble fraction and therefore solubilization by alkaline earth metal compounds in the process of Segall (US 2014017379) would not be appropriate and would not result in the claimed product, the Examiner notes that no evidence beyond assertion is provided that solubilization by alkaline earth metal compounds would prevent extraction of globulins. Segall does not explicitly refer to the presence or removal of globulins. Furthermore, additional process steps could also be used to remove 100% globulins. The Examiner further notes that the Applicant's claimed process (Specification, Paragraph 0061) for producing a soluble fraction comprises acidifying a high protein content solution, heating to coagulate proteins of the globulin type, and separating by centrifugation. If the Applicant is contending that the higher pH used at certain stages of the process of Segall would prevent globulins from being separated, the Examiner notes that Segall teaches (Paragraph 0065, 0066) embodiments, wherein an aqueous pulse protein solution is optionally acidified, heated, and centrifuged prior to raising the pH, and, due to the resemblance to the Applicant's claimed process, removal of globulins would be expected to occur.
In response to the Applicant's argument that, since the product is presently directed to being obtained from the process consisting of four steps i)-iv) mentioned in claim 14, the addition of calcium salt or other alkaline earth metal compounds referred to in Segall cannot be encompassed by said claim, the Examiner maintains that the claimed process does not forbid the use of calcium salt or other alkaline earth metal compounds, and the product claims also do not exclude calcium salt. The claimed process includes “pretreating leguminous plant seeds”, which is broad, does not appear to be limited by the specification, and could include the addition of alkaline earth metal compounds. This also applies to the other process steps, which do not forbid the use of alkaline earth metals. Thus, a product resulting from the claimed process does not exclude the presence of alkaline earth metal compounds. This is further supported by the fact that the claimed soluble fraction can include salts. Furthermore, Segall is silent on whether or not alkaline earth metals would still be present in the final soluble fraction, but does indicate (Paragraph 0090) the soluble fraction may be further processed by membrane concentration and/or diafiltration, which may remove or reduce the alkaline earth metals since diafiltration can remove contaminants (Segall, Paragraph 0074). Furthermore, the claim, as currently presented, does not exclude any specific salt.
Regarding the Applicant's argument that Segal (US20140093626) does not teach or suggest how to obtain a soluble fraction according to currently amended claim 14 since the extraction process of Segall (US20140093626) comprises the step of solubilization with calcium salt solution to cause solubilization of the pulse protein from the protein source and form a pulse protein solution, and, the use of calcium salt would not result in the claimed product for the reasons stated previously with regard to Segal (US20140017379), the Examiner maintains that the use of calcium salt in Segal (US20140093626) would not be incompatible with the claimed invention for the same reasons stated above with regard to Segal (US20140017379). Furthermore, Segall (US20140093626) is relied upon simply to demonstrate that the claimed coloration (L and a) values are known and would be obvious to one of ordinary skill in the art. Not every feature of a secondary reference must be integrated into the primary reference for a feature of a secondary reference to be obvious. For example, achieving the claimed ranges for components L, a, and b could be achieved by adjusting the relative proportions of the soluble fraction and pulp, controlling or changing the drying technique, using a different type of pea, etc., in consideration of Segall (US 20140093626 A1) and the reasons for routine experimentation stated in the rejection.
The Applicant further argues that Example 2 demonstrates that the lysine and color profiles are unexpected, since the skilled person would have expected drying a mixture of the pea soluble fraction and pea pulp fraction to be unfavorable, because the lysine fraction would be expected to undergo significant Maillard degradation during drying and since the claimed product does not merely have an arbitrary color value; it maintains a light color profile under heat treatment conditions where the comparative wheat-based product darkens significantly.
The Examiner notes, first, that it is unclear if the drying process of Example 2 refers to the drying step used to produce the claimed product or if the drying process in the example is drying an already completed product to show unexpected properties of the product.
In the former case, the Examiner understands the Applicant to be arguing that the claimed coloration and lysine content of the product are unexpected, as shown by Example 2, because the drying process would be expected to produce a product with a different coloration and lysine content. However, the patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (See MPEP 2113 I). Moreover, the claimed invention only recites "drying the mixture" with no limits on the time, temperature, or manner of drying, and therefore, the claimed drying step is broader in scope than the 100°C drying process for 120 minutes described in Example 2, and results of the example drying process cannot be understood to apply to the claimed invention.
In the latter case, the Examiner understands the Applicant to be arguing that claimed lysine content and coloration have an unexpected effect on drying. The Examiner maintains that Example 2 does not appear to show such a result. First, the example only refers to a "pea-based product according to the invention". The Applicant's Specification contains multiple embodiments for solids content, “L”, “a”, and “b” values, and lysine content. It is not clear at all that the product used in Example 2 is the same as that claimed by the Applicant. Second, Example 2 alleges that the change in lysine content and coloration is unexpected compared to a wheat product, but nothing states that claimed coloration and lysine content is the cause of this unexpected result. It appears that the Applicant may be suggesting that the claimed coloration and lysine content has a unique effect on the change in coloration and lysine content when the product is heated, but this is not supported by the Example. Third, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
The Applicant further argues that the dryings step would be unexpected because the EFISC Sector Reference Document suggests that pea soluble should be concentrated and evaporated rather than dried because of the lysine degradation and digestibility loss. Again, the patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (See MPEP 2113 I). It is unclear what the Applicant is arguing. Is the Applicant suggesting that the claimed product has features not found in the prior art (Boursier, as modified) as a result of drying? This seems to contradict the Applicant's assertion that the claimed drying process does not result in degradation of lysine of digestibility loss, i.e. the process does not meaningfully change the product properties compared to other processes like evaporation as described by the EFISC Sector Reference Document. Furthermore, the prior art teaches the claimed product and that product claims are not limited to the steps of a product-by-process claim unless those steps result in a different product. Additionally, comparison to the specific drying process of Example 2 is not necessarily representative of the drying required to produce the claimed product, which, at best, would require drying to a moisture content of at most 14.999...% because the claim recites a solids content greater than 85%.
Regarding the Applicant's argument that the process is central to obtaining the claimed product with the desired characteristics, and Fenioux contains no teaching that its protein isolate corresponds to such a residual aqueous soluble fraction, or that it is obtained after removal of globulin-type proteins into a separate fraction, and, at most, Fenioux discloses a lysine value for an undefined protein isolate, which could include proteins obtained by processes materially different from the presently claimed extraction process, including processes that retain or solubilize globulins rather than separating them from the soluble fraction, such as in Segall, the Examiner notes that not every feature of a secondary reference needs to be incorporated into the primary reference. In this case, Fenioux is simply relied upon to demonstrate that a pea protein isolate with a lysine content of between 3% and 10% by weight of its total protein content, is known in the art. Providing the product with the claimed lysine content need not be done in the exact same manner as Fenioux, nor as the Applicant, so long as the resulting product has the claimed features. As stated in the rejection, the claimed lysine content would have been used during the course of normal experimentation and optimization procedures in the method of Boursier such as by adjusting the relative amounts of protein and fiber, adjusting the amount of albumin (where albumins are richer in lysine compared to globulins (Chéreau et. al., Section 2.4)), manipulating the production process of the protein to control the resulting lysine content, adding additional lysine, etc.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Furthermore, In response to applicant's argument that the examiner has combined an excessive number of references, reliance on a large number of references in a rejection does not, without more, weigh against the obviousness of the claimed invention. See In re Gorman, 933 F.2d 982, 18 USPQ2d 1885 (Fed. Cir. 1991).
Consequently, for the reasons stated above, claim 14 and all dependent claims remain rejected under 35 U.S.C. 103.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Czuchajowska (US 5364471 A) teaches milling dehulled legumes to obtain a powder followed by wet separating (centrifugation) the small particle size fraction of said powder to separate pure starch from a protein concentrate.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AUSTIN PARKER TAYLOR/Examiner, Art Unit 1792
/VIREN A THAKUR/Primary Examiner, Art Unit 1792
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