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 1-2, 4-5, 7-8 and 13-15 are examined herein.
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.
Claims 1-2, 4-6 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Sumner in view of Hofman and Applicant’s Admitted Prior Art.
Sumner: Production and Evaluation of Pea Protein Isolate; JOURNAL OF FOOD SCIENCE, Vol. 46, 1981.
Hofman: WO 2010/126362, published Nov. 4, 2010.
Independent claim 1
Sumner teaches about dried protein compositions (ab.), which encompasses nutritional formulations, as claimed.
Pea protein isolate
On the total protein content of the powdered pea protein isolate being expressed as N.6.25 of more than at least 80% by weight of dry product: Sumner teaches that analysis of said pea protein isolates showed the composition has a protein content of 83 to 90 % (see top of pg. 366), wherein the protein content is analyzed by the micro-Kjeldahl procedure using a nitrogen factor of 6.25 (2nd para. on pg. 365), which encompasses the claim of a total protein content expressed as N.6.25 of more than at least 80% by weight of dry product.
On the free amino acids in the pea protein isolate: Sumner teaches that lysine is monitored (2nd para. on pg. 365 and 1st para on pg. 366), therefore imparts that the protein compositions have free amino acids, as claimed.
Sumner does not discuss the use of from 0.5% to 2% by weight of free amino acids.
Hofman also teaches methods of making pea protein, and further provides that pea protein isolates comprise: zero to 5 wt% of free amino acids, which encompasses the claim of between 0.5 and 2 wt% of free amino acids (pg. 8, see 3rd-4th full paras.)
It would have been obvious to one of skill in the art, at the time of filing/the invention to modify the method of making/using pea protein isolates, as the modified teaching above, to include information on the amino acids therein, including the amount thereof, as claimed, because Hofman shows that it was known for encompassing amount of amino acids to have been successfully achieved when making pea protein isolates, and this was published at the time of filing, which means it was within the general skill of a worker in the art to select between 0.5 and 2 wt% of free amino acids, as claimed, which means it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07.
On the functional properties of the pea protein isolate: When looking for light in the original disclosure, it is noted that a pea protein suspension is treated with an 1) amount of a specific type of enzyme to obtain the desired characteristics of the pea protein isolates; 2) for a desired final degree of hydrolysis; wherein the parameters are known, and a person skilled in the art can readily determine the appropriate conditions for obtaining the desired characteristics of the pea protein isolate (0351-0355).
Therefore, because the method of making the pea protein isolate is admitted to be known at the time of filing (Applicant’s Admitted Prior Art [AAPA]), it would have been obvious to one of skill in the art, at the time of filing to modify the method of using pea proteins isolates, as the modified teaching above, to include the required method of manufacture to obtain the claimed degree of hydrolysis and the claimed functional properties of the pea protein isolate, including:
a degree of hydrolysis (DH) of from 5% to 10%;
a viscosity when the measurement is taken on an aqueous solution of the pea protein isolate at 15% solids at a temperature of 20°C:
from 11 to 18x10-3 Pa.s. at a shear rate of10s-1;
from 9 to 16x10-3 Pa.s. at a shear rate of 40 s-1; and
from 8 to 16x10-3 Pa.s. at a shear rate of 600 s-1; and
a solubility of from 30 to 40% when in pH zones from 4 to 5; and
a solubility of from 40 to 70% when in pH zones from 6 to 8 (per p. 0293);
as claimed, because AAPA provides that it was known for pea protein isolates to have been within the skill of one in the art to achieve, at the time of filing, which means it was within the general skill of a worker in the art to select the claimed processing step of hydrolysing a pea protein to achieve the desired functionality, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
Further, since the modified teaching provides a similar composition comprising similar amounts of similar ingredients, which reflects the breadth of the claim composition, as made by similar methods, it would be reasonable to expect that the powdered pea protein isolate taught would function similarly when measured in a liquid form, absent a showing of criticality, because the teaching of a similar composition imparts a suggestion in or expectation that the composition taught will have the same or a similar utility/properties/ functionality because the claims are not physically or structurally distinguishable over the prior art compositions, therefore a sufficiently close relationship between the ingredients is provided to create an expectation that such a compositions would have similar properties/functionality, including the claimed viscosity and solubility when the powdered pea protein is measured, because composition claims are not limited to new uses/properties/functionality when a similar composition is known.
Finally, since the powdered pea protein isolate, is a single ingredient of the claimed composition, wherein powdered structure and properties or functionality of this single ingredient are toward the ingredient prior to its use, in some nutritional formulation, these limitations make no distinction over the modified teaching above, absent a showing of criticality, because the patentability of a composition is toward the chemical and physical structure of the formulation thereof, not that of a single unused ingredient.
Dependent claims
As for claims 2 and 4, although it is not written down, one in the art would have a reasonable expectation of success (it would have been obvious to them) that a similar pea protein isolate comprising similar ingredients, within the scope of the claims, would function similar, including:
having a digestibility expressed according to the Coefficient of Digestive Use (CDU) of from 93.5% to 95%, as in claim 2; and
according to the SYMPHID test, as a protein of "rapid viscosity", reflecting rapid duodenal assimilation of the constituent amino acids of said isolate, as in claim 4.
As for claim 5, the modified teaching, in Hofman, provides that protein compositions are pasteurized at high temperatures for a short time (see para. above the Characterization of the protein mixture and the para. above the Pea Protein section), wherein the formulation is in a powder form for to be reconstituted (last para. on pg. 20), therefore has been dried.
Further, in this case, there is no evidence that the claimed method steps are critical in regards to the claimed product, therefore the process parameters of the pasteurization step, at high temperature for a short time, and that such a step is before being dried by atomization, therefore absent a showing of criticality, they fail to distinguish over a the protein being pasteurized and powdered, as taught in the modified teaching above.
As for claim 7, the modified teaching, in Hofman, provides the nutritional composition further comprises whey (i.e. at least one milk protein) (starting at the bottom of pg. 6 and 2nd para. of Pea Protein section), as claimed.
As for claim 8, the modified teaching, in Hofman, provides the nutritional composition whey or casein proteins (see pg. 10), in amounts, comprising: 20 to 40 wt% of each (see the Nutritional composition section, on pg. 12), which encompasses the claim of a range of milk protein of at least 10, 15, 20, 25, 30, or 40 wt% relative to the total weight of protein in the nutritional formulation, as claimed.
As for the composition being in a powdered form, please see the discussion toward claim 1, above.
As for claim 13, Sumner provides the use of the powdered pea protein isolate as a functional protein ingredient (see the last sentence of the article), which imparts its intended use of the nutritional composition as a food supplement, as claimed.
As for claim 14, since the modified teaching above provides a similar composition, having a similar pea protein isolate, made by a similar method, within the scope of the claims and the disclosure of the method of manufacture, it would be reasonable for one in the art (i.e. it would have been obvious) that similar compositions have similar intended uses, including:
a beverage in powder form to be reconstituted or a ready-to-drink beverage;
a beverage for dietetic nutrition (sports, slimming) or for clinical nutrition;
a dessert cream in clinical nutrition;
a nutritional liquid administered enterally:
a fermented milk of yoghurt type (stirred, Greek, drinking, etc.);
a dairy/plant-based beverage;
a dairy/plant-based cream (such as "coffee whitener");
an iced dessert or sorbet;
a biscuit, muffin, griddle cake or nutritional bar;
a protein-enriched bread or gluten-free bread; or
high-protein cereals, obtained by extrusion cooking, as claimed.
As for claim 15, Sumner provides the use of pea protein isolate as a functional protein ingredient (see the last sentence of the article); and further provides narrow and broad examples: wherein 6 grams of the pea protein isolate is used with 100 mL (i.e. 100 grams) of water, which imparts 6 wt%; and wherein the pea protein isolate makes up to 100 wt% of nutritional compositions (see Table 3); which shows an expection that the amount of the pea protein isolated used in foods is open to any amount.
Further, Hofman provides that it was known for amounts of pea protein to be using in nutritional compositions, including:
25 wt%, 2.6 wt%, 5 to 60 wt%, and from 25 to 80 wt% (see the Background); and from 25 to 80 wt% (see the Summary), which also imparts a broad teaching wherein any amount thereof is expected.
Therefore the modified teaching encompasses at least the claimed amounts of pea protein, including::
between 40 and 100 wt%;
between 0.1 and 100 wt%’
between 52 and 100 wt%; and
between 50 and 100 wt%, as required in claim 15.
As for the intended use of the composition, please see the rational provided in claim 14, which is incorporated herein.
Double Patenting
Claim 1 of this application is patentably indistinct from claim 1 of Application No. 18/380845. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
Response to Arguments
REMARKS
Reconsideration and withdrawal of the rejections of the pending claims are respectfully requested in view of the amendments and remarks herein, which place the application in condition for allowance.
CLAIM STATUS
It is asserted, that Claims 1, 2, 4, 5 and 7-16 are pending. Without prejudice or disclaimer, claims 1 and 8 are amended; and claim 6 is cancelled. No new matter is added. Support for this amendments may be found in specification and claims as originally filed. It is submitted that the claims presented herewith are patentably distinct over the prior art, and that these claims are in full compliance with the requirements of 35 U.S.C. §112. The amendments and remarks made herein are not made for purposes of patentability within the meaning of 35 U.S.C. §§ 101, 102, 103 or 112.
In response, Applicant’s timely response is appreciated.
CLAIM OBJECTIONS
It is asserted, that Claim 1 was objected to for informalities. The amendment to claim 1 renders the objections moot. Consequently, reconsideration and withdrawal of the objections to the claims are respectfully requested.
In response, Applicant’s timely response is appreciated, and said Objection is not re-issued herein.
35 U.S.C. §112 REJECTIONS
It is asserted, that Claims 1 and 6 were rejected as allegedly being indefinite; and claim 8 was rejected as allegedly being in improper dependent form. The amendments to the claims render the rejections moot.
In response, Applicant’s timely response is appreciated, and said Rejection is not re-issued herein.
It is asserted, that Applicant also believes that claim 8 is a proper dependent claim from claim 7 and asks the Examiner for clarification. Consequently, reconsideration and withdrawal of the Section 112, second and fourth paragraph, rejections are respectfully requested.
In response, the examiner agrees with Applicant’s argument, therefor said Rejection is not re-issued herein.
35 U.S.C. §103 REJECTIONS
It is asserted, that the instantly claimed invention is directed to a nutritional formulation comprising a powdered pea protein isolate. The pea protein isolate has critical features:
between 0.5 and 2% by weight of free amino acids,
the claimed viscosity when the measurement is taken on an aqueous solution of the pea protein isolate at 15% solids at a temperature of 20°C,
a degree of hydrolysis (DH) of between 5 and 10%; and
a total protein content expressed as N.6.25 of more than at least 80% by weight of dry product.
These critical features allow for a high protein enrichment without a negative impact on the preparation process or texture of the preparations or finished products (nutritional formulation) in which the pea protein isolate is incorporated. The pea protein isolate of the claimed invention makes it possible, for example, to improve the solubility relative to pea protein, and to reduce the viscosity in water relative to pea protein.
The pea protein isolate has both high solubility and low viscosity, which constitutes a superior combination of properties suitable for applications in the nutritional formulations. No document cited by the Examiner leads a skilled artisan to such an invention or to the advantages thereof. Sumner is a scientific publication focused on developing laboratory and pilot plant processes for producing pea protein isolate from field peas (Pisum sativum L. var. Trapper). The rationale is to evaluate field peas as a high-protein crop and to compare the properties of pea protein isolates with those of soy protein isolates.
As recognized by the Examiner, Sumner does not disclose the free amino acids content of its isolates, neither their viscosity when on an aqueous solution.
Regarding solubility, Sumner notes in Table 4 pea protein isolates having a very low solubility at pH 4.5 (always below 5% whereas the pea protein isolate of the invention has a solubility from 30 to 40% in pH zones from 4 to 5). Regarding the degree of hydrolysis, Sumner does not use or measure a DH because no hydrolysis step is carried out in the extraction process used in this document.
Therefore, the claimed nutritional formulation from claim 1 differs from Sumner at least by:
1) its free amino acids content,
2) its degree of hydrolysis,
3) its viscosity, and
4) its solubility in pH zones from 4 to 5.
In response, initially, it is noted that a proper showing of criticality of the claimed properties/functionality of the claimed composition has not been presented to the office for consideration.
A showing of criticality, requires criticality being presented to the Office in a manner similar to that of a showing of unexpected result. An experimental design needs to comprise all combinations across all levels of each factor. It must be capable of estimating related factors and their interactions, for example as a full factorial design would show, wherein the total number of unique runs in a full factorial experimental design for fixed-level designs may be calculated as bf, where b is the number of levels for each factor, and f is the number of factors. For example, a complete factorial design of three factors, each at two levels, would consist of 23 = 8 runs. Similarly, a complete factorial design consisting of five factors at two levels and four factors at three levels would require of 25 * 34= 2,592 unique runs. The more limited the claims require a design with less experimental runs.
A proper showing of criticality must include the following:
1. Evidence of criticality must be in the form of a direct comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. The showing of criticality must be commensurate in scope with the invention as claimed. See MPEP 716.02(d).
2. The declaration must provide:
a. A description of precisely what was tested. It must include both:
b. The invention as claimed, AND
c. The closest prior art
d. A description of all of the test conditions.
e. Test results. The results must include:
i. The actual steps carried out, the materials employed, and the results obtained should be spelled out. Nothing concerning the work relied upon should be left to conjecture.
ii. The results of the test performed on the invention as claimed.
iii. The results of the test performed on the closest prior art.
iv. A showing of statistical and practical significance of the criticality. (i.e. several data points that confirm the test result was not just a statistical flier.)
f. An analysis of the test results, including, wherein the results must be due to the claimed features (including how the ranges for the components are established, in other words how the specifically claimed ranges provide the unexpected result), not to unclaimed features.
Further, if any sensory properties are being shown, then extensive details on the sensory program, training, facilities, criteria, etc. also needs to be included. The examiner can provide a reference showing information required for such thing, upon request.
Then, after a proper showing of criticality is provided and considered by the office, wherein the examiner must determine if the same result would be expected/obvious in view of the prior art.
Then, regarding the claimed nutritional formulation from claim 1 differing from Sumner at least by: its free amino acids content, Hoffman is provided, therefore this is a piecemeal analysis of the rejection of record that picks apart the references vs taking the modified teaching as a whole.
Similarly, because the method of making the pea protein isolate is admitted to be known at the time of filing (Applicant’s Admitted Prior Art [AAPA]), it would have been obvious to one of skill in the art, at the time of filing to modify the method of using pea proteins isolates, as the modified teaching above, to include the required method of manufacture to obtain the claimed degree of hydrolysis and the claimed functional properties of the pea protein isolate, including:
2) its degree of hydrolysis,
3) its viscosity, and
4) its solubility in pH zones from 4 to 5.
Therefore this argument is not persuasive.
It is asserted, that the Examiner relies on Hofman to remedy Sumner's deficiency regarding the free amino acids content. Hofman relates to a pea-based protein mixture and its use in a liquid nutritional composition, in particular suitable for tube feeding. On the free amino acid content of the pea protein, the Examiner considers that in Hofman the pea protein comprises 0 to 5 wt% of free amino acids (page 8, 3rd_4th paragraphs), thus allegedly encompassing the claimed range of from 0.5 to 2%. The Applicant respectfully contests this analysis.
Hofman, however, describes (page 8, 1.22-24) a composition, which is a pea-based protein mixture (i.e. comprising pea protein but not only), which "may comprise a free amino acid, or a mixture of free amino acids, up to 5 gram 100 ml, more preferably less than 2 gram100 m
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l, more preferably less than 1 gram 100 ml, most preferably less than 0.5 gram 100 ml." This free amino acid content is here clearly relative to the content of the composition expressed in grams relative to 100 ml of the composition, and not to the content of the pea protein.
The density of the composition (pea-based protein mixture) is given (page 19, 1. 20-22) as ranging "between 1.00 g/ml and 1.20 g/ml", then the free amino acids weight content of the composition can be estimated as up to 5 weight % relative to the weight of the composition. Since the composition described in Hofman comprises pea protein but also other ingredients such as a second vegetable protein (soy, rice or wheat protein) and dairy proteins, the free amino acids weight content of the pea protein is here necessarily superior to 5 weight %, thus not encompassing the claimed range (from 0.5 to 2% by weight). Furthermore, on the protein content, viscosity, and solubility parameters of the pea protein, Hofman is totally silent and Hofman's pea protein is non-hydrolysed whereas the pea isolate of the invention is hydrolysed to reach a DH from 5 to 10%.
In response, the claims are open to a composition comprising any amount of the pea protein isolate, therefore from above 0.01 wt% up to 100 wt%, therefore the modified rejection indeed provides an amount of the free amino acids that is encompasses by such a thing.
It is asserted, that the purpose of the present invention is to present a superior nutritional formulation comprising a pea protein isolate that can totally or partly substitute for milk or soybean protein, of neutral taste, and which have suitable properties for mixing powders, ready-to-drink ULHT sterilized beverages containing protein and enterally administered nutritional liquids: in which low viscosity of the beverage and improvement of the pea protein solubility are desired and also in fermented milks of yoghurt type, dairy/plant-based beverages, dairy/plant- based creams, iced desserts or sorbets, in which the emulsifying capacity of said pea protein isolate is of interest for its use in the matrices of these dairy products in partial or total substitution for dairy protein, vegan cheeses, and in which the addition of said pea protein isolate makes it possible to improve the shreddability, the melting and the taste of mozzarella-type vegan cheeses.
The present invention also provides for nutritional formulations comprising a pea protein isolate having properties suitable for: biscuits, muffins, griddle cakes or nutritional bars, protein- enriched breads or gluten-free breads, high-protein cereals, obtained by extrusion cooking. These various properties contribute toward obtaining the desired final characteristics of the nutritional formulations. As explained above, the critical combination of free amino acid content, viscosity and solubility in the pea protein isolate of the claimed invention allows a high protein enrichment without a negative impact on the preparation process or texture of the preparations or finished products (nutritional formulation) in which the pea protein isolate is incorporated. The pea protein isolate of the claimed invention makes it possible to improve the solubility relative to pea protein, and to reduce the viscosity in water relative to pea protein. The pea protein isolate has both high solubility and low viscosity, which constitutes a superior combination of properties suitable for applications in the nutritional formulations recited in claim
As no combination of the documents relied upon by the Patent Office would lead a skilled artisan to the instantly claimed invention with any expectation of success, the rejection should be withdrawn. Consequently, reconsideration and withdrawal of the Section 103 rejection are respectfully requested.
In response, as for the intended uses of the composition claim presented in claim 14, this argument is not persuasive, because:
See MPEP 2144. III, which states that when case law imparts legal precedence, wherein the facts in this prior legal decision are sufficiently similar to those in an application, wherein the court applied the law of obviousness to similar facts. This includes a wide spectrum of illustrations and accompanying reasoning (i.e. obviousness) that exist in case law. In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990). Herein, although not cited in the MPEP, more recent caselaw on the topic, “In re Dillon, 919 F.2d 688 (1990)” ( (https://cite.case.law/f2d/919/688/)) provides that when a claimed compositions has been made obvious from combined teachings, it is clear that the discovery that the claimed composition possesses a property/finctionality not disclosed for the prior art subject matter, and this itself does not defeat a prima facie case. Herein, since the modified teaching provides a similar composition comprising similar amounts of similar ingredients, made by a similar method, which similarly functions as a food comprising a pea protein isolate, which reflects the breadth of the claim composition, it would be reasonable to expect that the taught composition imparts a suggestion in or expectation that the composition taught will have the same or a similar utility.
Also, MPEP § 2111.02.II teaches, that when the claims are toward the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the instant case, the noted preamble merely states the purpose or intended use of the claimed composition.
DOUBLE PATENTING REJECTION
It is asserted, that the Examiner alleges that claim 1 of the instant invention is patentably indistinct from claim 17 of US 18/380,845. Applicant respectfully disagrees. Instant claim 1 is directed to a nutritional formulation comprising a pea protein isolate. Claim 17 of US 18/380,845, by contrast, is directed to a pea protein isolate per se. The claims are distinguishable. Consequently, reconsideration and withdrawal of the double patenting rejection are respectfully requested.
In response, since the composition claimed only requires a single ingredient, that comprises the only ingredient claimed to be in the composition of claim 17 of US 18/380,845, the examiner does not agree, with this argument.
Further absent a showing of criticality, since the modified teaching above provides a similar composition consisting of similar ingredients, in similar amounts, made by a similar method, it would be reasonable to expect that the similar composition would function similarly and have similar uses, including those claimed (e.g. claim 14), absent a showing of criticality, because the teaching of a similar composition imparts a suggestion in or expectation that the composition taught will have the same or a similar utility.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICIA ANN GEORGE whose telephone number is (571)272-5955. The examiner can normally be reached T-TH 9:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at (571)272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Patricia George
Primary Examiner
Art Unit 1793
/PATRICIA A GEORGE/Primary Examiner, Art Unit 1793