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 .
Application Status
Amended claim 1 and 5 are under examination.
Claim 1 and 5 are rejected.
Claim 6-10 are withdrawn.
Claim 2-4 are cancelled.
Withdrawn Rejection
The objection set forth in previous office action have been withdrawn in light of Applicant’s amendment.
The 112, second paragraph rejection over claim 1 and 5 have been withdrawn in light of Applicant’s amendment.
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.
Claim 1 and 5 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.
Claim 1 is not written in proper claim construction, wherein the claim structure does not recite a transitional language of “comprising” or “consisting”; hence it is not clear as to if the claim is open-end or close-end. The metes and bounds are not clearly set forth in the claim. Claim 5 is also rejected since the claims are depended upon rejected claim 1. For examination purpose, the claim is considered transitional language of “comprising”, in other words open-ended that does not preclude additional components and/or amounts.
Claim 1 recites “having the ability to be used in a food texturation process by a food extrusion process…” is confusing. It not clear how a process, i.e. food extrusion process is able to use pea protein isolate in another process, i.e. food texturation process. The metes and bounds are not clear set forth in the claim since the claim is directed to a product.
Claim 1 recites the limitation of “wherein its content of sodium” is confusing. It is not clear as to what Applicant intend “its” refers to the pea protein isolate, the food texturation process, the food extrusion process or a product obtained by the process(es); hence the claim is indefinite. For examination purpose, the recitation is considered as wherein the pea protein isolate comprises a content of sodium in a range from 0.3% to 0.6%.
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.
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.
Claim(s) 1 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Kizer et al. (WO 2017/120597).
Regarding claim 1 and 5, with respect to the new recitation of “…pea protein isolate having the ability to be used in food texturation process by a food extrusion process” in claim 1, is considered a functional limitations of the claimed product; hence it has been held that where the claimed and prior art products are identical or substantially identical in structure or are produced by identical or substantially identical process, a prima facie case of either anticipation or obviousness will be considered to have been established over functional limitation that stem from the claimed structure (product). The prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed products. In re Best, 195 USPQ 430, 433 (CCPA 1977), In re Spade, 15 USPQ2d 655,1658 (Fed. Cir. 1990).
Kizer et al. (Kizer) discloses a refined protein isolate (pea protein isolate) of non-animal natural source including plant (‘597, [0047], [00106], [00131, [00149]), wherein the plant source is pea protein isolate (‘597, [00162], [00174]), comprising sodium content of less than 0.5% by weight (‘597, [00118]), which overlaps the cited range of between as cited in claim 1 and 5. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Kizer discloses the refined protein isolate (pea protein isolate) comprising between about 0.5% and about 1% by weight of calcium (‘597, [0093]), which is in range with the cited range below 1% by dry weight on dry matter.
With respect to claim 1, Kizer discloses the refined protein isolate (pea protein isolate) comprising potassium content of less than 0.5% by weight (‘597, [00118], [00322]). Kizer does not explicitly discloses the potassium content as cited in claim 1. Kizer clearly teaches additional ingredients (‘597, [0078]) added to protein component, i.e. refined protein isolate, wherein the additional ingredients includes minerals or salts containing potassium (‘597, [00156], pg. 30, 31). Kizer teaches the additional ingredient of salts containing potassium (‘597, [00156], pg. 30, 31) enhance flavor and enhance protein stability (‘597, [00156], pg. 31). It would have been obvious to one of ordinary skill in the art to adjust Kizer’s potassium content including the cited amounts in Kizer’s refined protein isolate (pea protein isolate) to provide a desired flavor profile and enhance protein stability as taught by Kizer (‘597, [00156], pg. 31).
Additionally, potassium are comment ingredients, attention is invited to In re Levin, 84 USPQ 232 and the cases cited therein, which are considered in point in the fact situation of the instant case, and wherein the Court stated on page 234 as follows:
This court has taken the position that new recipes or formulas for cooking food which involve the addition or elimination of common ingredients or for treating them in ways which differ from the former practice, do not amount to invention, merely because it is not disclosed that, in the constantly developing art of preparing food, no one else ever did the particular thing upon which the applicant asserts his right to a patent. In all such cases, there is nothing patentable unless the applicant by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected, and useful function. In re Benjamin D. White, 17 C.C.P.A (Patents) 956, 39 F.2d 974, 5 USPQ 267; In re Mason et al., 33 C.C.P.A. (Patents) 1144, 156 F.2d 189, 70 USPQ 221.
Kizer discloses the refined protein isolate of the non-animal natural source including plant (‘597, [0047], [00106], [00131, [00149]) comprising 5% to 97% by weight of protein (‘597, [00280]), which overlaps the cited range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Response to Arguments
Applicant asserts “…The Examiner alleges in paragraph 16 of the Office Action that Kizer discloses a refined protein (pea protein isolate) comprising 0.36% by weight of calcium (Table 7, Row: SES 1, column: Refined PI). The Applicant disagrees and respectfully points out that the Examiner made an erroneous interpretation of Kizer. Indeed, according to paragraph [00174] of Kizer, “SES” stands for “Sesame” and not “Pea”. “Yellow Pea” is noted as “YPE”. According to Table 7, samples YPE 1 and YPE 2 have calcium contents of 1.03% and 1.08% respectively”.
Applicant’s remark is convincing. However, Kizer clearly teaches the refined protein isolate (pea protein isolate) comprising between about 0.5% and about 1% by weight of calcium (‘597, [0093]), which is in range with the cited range below 1% by dry weight on dry matter, and meets the limitation of the claim.
Applicant's arguments pg. 6-9 have been fully considered but they are not persuasive.
Kizer clearly teaches additional ingredients (‘597, [0078]) added to protein component, i.e. refined protein isolate, wherein the additional ingredients includes minerals or salts containing potassium (‘597, [00156], pg. 30, 31). Kizer teaches the additional ingredient of salts containing potassium (‘597, [00156], pg. 30, 31) enhance flavor and enhance protein stability (‘597, [00156], pg. 31). It would have been obvious to one of ordinary skill in the art to adjust Kizer’s potassium content including the cited amounts in Kizer’s refined protein isolate (pea protein isolate) to provide a desired flavor profile and enhance protein stability as taught by Kizer (‘597, [00156], pg. 31).
Additionally, potassium are comment ingredients, attention is invited to In re Levin, 84 USPQ 232 and the cases cited therein, which are considered in point in the fact situation of the instant case, and wherein the Court stated on page 234 as follows:
This court has taken the position that new recipes or formulas for cooking food which involve the addition or elimination of common ingredients or for treating them in ways which differ from the former practice, do not amount to invention, merely because it is not disclosed that, in the constantly developing art of preparing food, no one else ever did the particular thing upon which the applicant asserts his right to a patent. In all such cases, there is nothing patentable unless the applicant by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected, and useful function. In re Benjamin D. White, 17 C.C.P.A (Patents) 956, 39 F.2d 974, 5 USPQ 267; In re Mason et al., 33 C.C.P.A. (Patents) 1144, 156 F.2d 189, 70 USPQ 221.
It appears, Applicant’s remarks are to functional property of the pea isolate, i.e. ability to be used in food texuration process by a food extrusion process; hence it has been held that where the claimed and prior art products are identical or substantially identical in structure or are produced by identical or substantially identical process, a prima facie case of either anticipation or obviousness will be considered to have been established over functional limitation that stem from the claimed structure (product). The prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed products. In re Best, 195 USPQ 430, 433 (CCPA 1977), In re Spade, 15 USPQ2d 655,1658 (Fed. Cir. 1990).
Additionally, with respect to Example 7 with a mixture of the example 4 for unexpected results, does not commensurate with the scope of claim 1 and 5. Applicant’s Example 4 have a specific value of protein content, i.e. 87% with 13% of fiber (Example 7), and specific value of sodium, potassium, and calcium contents (show on table, pg. 5, [0094]) for the unexpected result of good fibre formation as Applicant asserts, however the instant claim have board ranges additionally does not require an amount of calcium content in the claims; hence there is no nexus between the instant claims and the claimed unexpected results. Additionally, it is not clear what parameters does Applicant considered a definition of “good fibre formation” or how does Applicant quantitative testing of “good fibre formation”. Furthermore, it appears the invention samples and prior art samples, have same “good fibre formation” (page 7, [0148]), since it is not clear what is the unexpected results as both invention and prior art samples have the same characteristics.
Furthermore, it is noted instant claim 1 the limitation of “…content of calcium is below 1% by dry weight on dry matter…” encompass a range of zero of calcium in the claimed product.
Applicant has not provided sufficient proper showing of unexpected results as in the claimed range.
A proper showing includes:
A description of precisely what was tested.
A description of all of the test conditions.
a. Test results, including:
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. 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.)
b. An analysis of the test results, including:
i. Conclusory statements.
ii. 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, including 4 sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range.
In this case, there is no description of how the taste test was performed, and no showing of all the test conditions. Test results are do not provide this in Example 4 of the Specification. There is no 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.) The results are not shown to 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, including 4 sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range.
Lastly, there are not data provided to the claimed ranges of claim 1, the content of calcium with a range of 0% to 1% of unexpected results. Hence, Applicant’s assertions of Example 4 with specific values of calcium, sodium, potassium and protein content for unexpected results is not a proper showing of unexpected results commensurate with instant claim 1 and 5.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG THI YOO whose telephone number is (571)270-7093. The examiner can normally be reached M-F, 7AM to 3PM.
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/HONG T YOO/Primary Examiner, Art Unit 1792