DETAILED ACTION
Background
Claims 1-10 stand pending in the instant application. The claims as filed with the instant application on June 16, 2023 have been examined. No amendments have been filed.
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 .
Claim Objections
Claims 1-6 and 8-10 are objected to because of the following informalities:
In claim 1, at line 1 after “having both” delete [[of]],
at line 3 after “measured molecular weight distribution” replace [[shows that]] with --with--, and
at line 4 after “than 20,000 Da” replace [[is]] with -of--;
In claim 2, at line 2 before “a measured molecular weight distribution” replace [[, wherein]] with --having--,
at lines 2-3 and starting on line 2 after “measured molecular weight distribution” replace [[shows that]] with --with--, and
at line 3 after “less than 2,000 Da” replace [[is]] with -of--;
In claim 3, at line 2 before “a measured molecular weight distribution” replace [[, wherein]] with --having--,
at lines 2-3 and starting on line 2 after “measured molecular weight distribution” replace [[shows that]] with --with--, and
at line 3 after “10,000 Da or more” replace [[is]] with -of--;
In claim 4, at line 2 before “a measured molecular weight distribution” replace [[, wherein]] with --having--,
at lines 2-3 and starting on line 2 after “measured molecular weight distribution” replace [[shows that]] with --with--,
at line 3 after “less than 2,000 Da” replace [[is]] with -of--, and
at line 4 after “10,000 Da or more” replace [[is]] with --of--;
In claim 5, at line 3 after “prepared” replace [[while]] with --by--, and
at line 4 before “pH to 7” insert --the --;
In claim 6, at line 3 after “prepared” replace [[while]] with --by--, and
at line 4 before “pH to 7” insert --the --;
In claim 8, at line 2 after “derived from” insert -- a--;
In claim 9, at line 2 after “derived from” insert -- a--; and,
In claim 10, at line 2 after “derived from” insert -- a--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1, at line 7 the recited “protein concentration of 0.1%” is indefinite because it lacks a unit basis for percentage. Is the recited % a weight %, a mass %, a volume % or a % of protein based on some other measure of the protein?
The Office interprets the recited 0.1% concentration of a denatured protein material to be a weight % (wt%).
In claim 1, at line 8, the term “upon addition of a 250 mM4 guanidine hydrochloride solution”, and at line 9, the term “upon addition of 2 M ammonium sulfate” are both indefinite. The claim as written includes addition of any amount including even the smallest possible amount of each of the recited guanidine hydrochloride solution and the recited ammonium sulfate, which effectively renders the tests meaningless and includes in the scope of the claim virtually any protein material. The Office interprets the claim as reciting a test comprising adding a volume of a 250 mM guanidine hydrochloride solution equal to the volume of the aqueous solution with a 0.1% crude protein concentration as in the instant specification at [0037], and a test comprising adding a volume of the 2 M ammonium sulfate added equal to the volume of the aqueous solution with a 0.1% crude protein concentration as in the instant specification at [0038].
Claims 2-10 are rejected as depending from a rejected base claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over JP06070691 A to Yoshitomi et al. (Yoshitomi), of record.
All references to Yoshitomi refer to the translation provided by Applicants.
Unless otherwise indicated, all disclosed percents (%) not accompanied by units are interpreted as weight %s (wt%), which is considered interchangeable with mass%.
The Office interprets the recited 0.1% concentration of a denatured protein material in claim 1 to be a weight % (wt%). Further, the Office interprets the two recited turbidity tests in claim 1 as comprising adding a volume of a 250 mM guanidine hydrochloride solution equal to the volume of an aqueous solution with a 0.1% crude protein concentration (as in the instant specification at [0037]), and comprising adding a volume of the 2 M ammonium sulfate added equal to the volume of an aqueous solution with a 0.1% crude protein concentration as in the instant specification at [0038].
Regarding instant claims 1-10, Yoshitomi at (57)[Overview] on page 2 discloses a denatured protein material (claims 1-10) made by hydrolyzing, heating, denaturing, coagulating and finely grinding a protein. At Example 1, Yoshitomi discloses an enzymatic hydrolysate of soybean protein (a protein “derived from a bean” in claims 7-10 and a protein “being free of an animal protein” in claim 6) having a starting molecular weight distribution of up to 10,000 Da (10 kg) the pH was then adjusted to 4.0 by adding vinegar, the mixture was heated with stirring until it reached 80°C for 5 minutes and passed through a microfluidizer at 80°C, yielding about 10 kg of a protein hydrolysate as an aqueous paste comprising 12 wt% protein solids having a very smooth emulsion-like texture. No separation occurred even when the paste was allowed to stand at room temperature for 30 days, and it remained in a stable homogeneous state even when diluted five-fold. Further, at [0013] on page 5 and claim 1 on page 3, Yoshitomi discloses a hydrolyzed denatured protein material having a molecular weight distribution of from 1,000 to 20,000 Da with outlier molecular weights removed by centrifugation and/or dialysis.
Yoshitomi does not disclose the guanidine hydrochloride or ammonium sulfate testing of a solution of its denatured protein material and does not provide a detailed molecular weight distribution of its denatured protein material.
Further regarding instant claims 1-4 and 6, the Office interprets the Example 1 enzyme hydrolyzed, denatured protein material of Yoshitomi having a starting molecular weight distribution of 10,000 Da, and having proteins larger than 1,000 Da in size as in claim 1 of Yoshitomi as being substantially the same thing as the claimed denatured protein material which is made by denaturing and then enzyme hydrolyzing a protein as in the instant specification at [0027]-[0029] via denaturation as in [0028] and enzyme hydrolysis as in [0029] of the instant specification. Accordingly, absent a clear showing as to how the molecular weight distribution of the soybean protein of Yoshitomi differs from that of the denatured protein material as claimed, the Office considers the Example 1 denatured protein material of Yoshitomi to have a) a measured molecular weight distribution with an area ratio of 2,000 Da or more and less than 20,000 Da of 45 to 90%” as in claim 1; to have a measured molecular weight distribution with an area ratio of less than 2,000 Da of 45% or less as in claim 2; to have a measured molecular weight distribution with an area ratio of more than 10,000 Da of less than 50% as in claim 3; and, further, to have an area ratio of less than 2,000 Da of 45% and an area ratio of more than 10,000 Da of less than 50% as in claim 4 and its dependent claim 6.
Still further regarding instant claim 1 and further regarding instant claims 5-6, the Office considers the aqueous denatured, enzyme hydrolyzed soybean protein of Example 1 of Yoshitomi having an emulsion like texture and forming a stable aqueous mixture to be substantially the same thing as the claimed aqueous solution of a denatured protein material. Accordingly, absent a clear showing as to how the turbidity and optical density of the claimed 0.1% aqueous solution of the denatured protein material of Example 1 of Yoshitomi differs from that of the denatured protein material as claimed, the Office considers the denatured protein material of Example 1 of Yoshitomi to have the claimed turbidity as b) an aqueous solution of the denatured protein material with a crude protein concentration of 0.1 wt% remaining unturbid upon addition of an equal volume of a 250 mM guanidine hydrochloride solution, and becoming turbid upon addition of an equal volume of a 2 M ammonium sulfate as in claim 1; to have an OD660nm of 0.5 or less as a 10 mass% aqueous solution of the protein having a pH of 7 as in claim 5; and to have an OD660nm of 0.5 or less as a 10 mass% aqueous solution of the protein having a pH of 7 as in claim 6. See MPEP 2112.01.I.
Claims 1-10 are rejected under 35 U.S.C. 103 as unpatentable over US 5082672 to Hamada et al. (Hamada) in view of EP 0480104 A1 to Shen (Shen).
Unless otherwise indicated, all disclosed percents (%) not accompanied by units are interpreted as weight %s (wt%), which is considered interchangeable with mass%.
The Office interprets the recited 0.1% concentration of a denatured protein material in claim 1 to be a weight % (wt%). Further, the Office interprets the two recited turbidity tests in claim 1 as comprising adding a volume of a 250 mM guanidine hydrochloride solution equal to the volume of the aqueous solution with a 0.1% crude protein concentration (as in the instant specification at [0037]), and comprising adding a volume of the 2 M ammonium sulfate added equal to the volume of the aqueous solution with a 0.1% crude protein concentration as in the instant specification at [0038].
Regarding instant claims 1-10, Hamada at Figure 10 and Example 11 on col. 9 discloses a deamidated, denatured and hydrolyzed soy protein (“denatured protein material” as in claims 1-10, which is “derived from a bean” as in claims 7-10 and “being free of an animal protein” as in claim 6). The denatured protein material in Figure 10 and Example 11 of Hamada is denatured at 100 °C for 15 minutes, hydrolyzed with Alcalase enzyme, heat-treated at 100 °C for 15 to 30 minutes and then deamidated. In Example 7, at col. 4, lines 55-58 Hamada discloses that heat treating the soy protein at 100 °C for 2 hours increases deamidation 5.5 fold and, further (at col. 3, lines 27-31) discloses that a greater degree of hydrolysis enhances deamidation. Further, at col. 11, lines 53-64, Hamada discloses that its deamidated, denatured protein material is soluble at a pH of 7. And, at col. 11, line 65 to col. 12, line 15, Hamada discloses that its hydrolyzed denatured protein material exhibits improved emulsifying activity.
Further regarding instant claims 1 and 5-6, the Office considers the aqueous hydrolyzed, denatured soybean protein of Example 11 of Hamada having improved solubility and emulsifiability in water and the claimed aqueous solution of a denatured protein material made by denaturation as in the instant specification at [0028]-[0029] and molecular weight adjustment or hydrolysis as in [0029] of the instant specification to be substantially the same thing. Accordingly, absent a clear showing as to how the turbidity and optical density of the claimed 0.1% aqueous solution of the denatured protein material of Hamada differs from that of the denatured protein material as claimed, the Office considers the denatured protein material of Example 11 of Hamada to have the claimed turbidity as b) an aqueous solution of the denatured protein material with a crude protein concentration of 0.1 wt% remaining unturbid upon addition of an equal volume of a 250 mM guanidine hydrochloride solution, and becoming turbid upon addition of an equal volume of a 2 M ammonium sulfate as in claim 1; and to have an OD660nm of 0.5 or less as a 10 mass% aqueous solution of the protein having a pH of 7 as in claims 5 and 6. See MPEP 2112.01.I.
Further regarding instant claims 1-4 and 6, Hamada does not disclose a measured molecular weight distribution for its denatured protein material; further, Hamada does not disclose that its hydrolyzed, denatured protein material has “a) a measured molecular weight distribution with an area ratio of 2,000 Da or more and less than 20,000 Da of 45 to 90%” as in claim 1; still further, Hamada does not disclose a denatured protein material that has a measured molecular weight distribution with an area ratio of less than 2,000 Da of 45% or less as in claim 2; yet still further, Hamada does not disclose a denatured protein material that has a measured molecular weight distribution with an area ratio of more than 10,000 Da of less than 50% as in claim 3; and, Hamada does not disclose a denatured protein material that has a measured molecular weight distribution with an area ratio of less than 2,000 Da of 45% and an area ratio of more than 10,000 Da of less than 50% as in claim 4 and its dependent claim 6.
Shen at Abstract discloses a hydrolyzed, deamidated vegetable protein having excellent water solubility for use in foods. At page 3, lines 32-49 Shen discloses hydrolyzing and enzyme treating soy proteins for from 10 minutes to 4 hours to produce a product having (at page 4, line 12) a molecular weight distribution of between 800 and 4,000. The Office considers the hydrolyzed soybean protein product of Shen to have the claimed measured molecular weight distribution of a denatured protein material that (a) has an area ratio of from 45 to 90% of proteins of 2000 Da or more and less than 20,000 Da as in claim 1, a measured molecular weight distribution with an area ratio of less than 2,000 Da of 45% or less as in claim 2, a measured molecular weight distribution with an area ratio of more than 10,000 Da of less than 50% as in claim 3, and, a measured molecular weight distribution with an area ratio of less than 2,000 Da of 45% and an area ratio of more than 10,000 Da of less than 50% as in claim 4.
As of the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Shen for Hamada to continue its hydrolysis to form a denatured protein material having the claimed measured molecular weight distribution that (a) has an area ratio of from 45 to 90% of proteins of 2000 Da or more and less than 20,000 Da as in claim 1, a measured molecular weight distribution with an area ratio of less than 2,000 Da of 45% or less as in claim 2, a measured molecular weight distribution with an area ratio of more than 10,000 Da of less than 50% as in claim 3, and, a measured molecular weight distribution with an area ratio of less than 2,000 Da of 45% and an area ratio of more than 10,000 Da of less than 50% as in claim 4 and its dependent claim 6. Both references disclose hydrolyzed, deamidated soy proteins having improved water solubility for use in foods. The ordinary skilled artisan in Hamada would have desired to continue hydrolysis of its protein as in Shen to produce a denatured protein material of the claimed molecular weight to enhance deamidation and improve product water solubility.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW E MERRIAM whose telephone number is (571)272-0082. The examiner can normally be reached M-H 8:00A-5:30P and alternate Fridays 8:30A-5P.
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/ANDREW E MERRIAM/ Examiner, Art Unit 1791