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 .
Election/Restrictions
Applicant’s election without traverse of claims 1, 11 and 36-39 as noted by applicant in the previous response reply filed on 8/20/2025 is acknowledged.
Therefore, claims 2-10, 12-19, 25, are withdrawn from further consideration by the Examiner as being drawn to non-elected subject matter.
Therefore, the restriction is hereby made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 11, 36-39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
There is no support in the application for “without digestion”. Applicant points the examiner to paragraph 86, but this does not provide support. In fact, in paragraph 129, enzymatic digestion is performed. While paragraph 86 states that “[s]onication is a rapid process because it does not involve additional digestion” this does NOT provide support for no digestion. Further, it is not clear what “digestion” actually means.
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.
Claims 1, 11, and 36-39 are rejected under 35 U.S.C. 103 as being unpatentable over CN 109628536 in view of WO 2008/034116
CN teaches a method of increasing the bioactivity of a soybean protein peptide (a preparation method of a soybean protein peptide.... comprises the following steps of firstly, selecting a raw material powdery soybean protein isolate, and then sending the selected powdery soybean protein isolate into water to be dissolved; pretreating a dissolved soybean protein isolate solution, and then adjusting the pH of the soybean protein isolate solution; sending the pH-adjusted soybean protein isolate solution into a container for enzymolysis.... [by means of the preparation method of the soybean protein peptide, firstly, the solution is subjected to high-pressure and ultrasonic treatment (sonication), the structure of the soybean protein is changed, the better and more comprehensive contact between an enzyme and a substrate is promoted, the reaction process is accelerated, the time for extracting the soybean protein peptide is shortened, the antioxidant effect of the soybean protein peptide is improved, Abstract), comprising: providing a composition comprising a soybean protein peptide in solution and administering sonication to the composition at an amplitude and time interval that increases the bioactivity of said soybean protein peptide (electing raw material powdery soybean protein isolate, and then feeding the selected powdery soybean protein isolate into water for dissolving, Para. (0010); pretreating the dissolved soy protein isolate solution, and then adjusting the pH value of the soy protein isolate solution, Para. [0011]; feeding the soybean protein isolate solution after pH adjustment into a container for enzymolysis, and feeding the solution into ultrasonic equipment for ultrasonic treatment during enzymolysis, Para. [0012]; the ultrasonic treatment is added in the enzymolysis process of the soybean protein solution, the enzyme and the substrate can be better and more comprehensively contacted under the cavitation action and the mechanical action of the ultrasonic treatment, so that the reaction process is accelerated, the time for extracting the soybean protein peptide is reduced, and the antioxidant effect of the soybean protein peptide is improved, Para. [0027)).
CN fails to explicitly disclose wherein the lunasin is lunasin enriched soy powder.
WO is in the field of using soy peptides to lower total and LDL cholesterol levels (Title) and teaches a soybean protein peptide is lunasin (to compositions containing biologically active levels of naturally occurring lunasin.... lunasin enriched compositions can be obtained from soybean, Para. [0053)).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of CN to include a soybean peptide as taught by WO for the purpose of developing medicaments for the treatment of cholesterol resistance (WO, Para. [0045)). Note that “powder” makes no sense and is impossible by definition because it is dependent on claim 1 which stipulates that the composition lunasin is in a solution, thus it cannot be in powder form structurally or chemically by definition if it is in a solution.
WO teaches a composition comprises lunasin enriched soy powder (freeze drying to get a powder form of lunasin enriched seed extract, Para. {00138)).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of CN to include a soybean peptide as taught by WO for the purpose of developing medicaments for the treatment of cholesterol resistance (WO) Para. [0045)).
MPEP 2144.05, subsection II.
II. ROUTINE OPTIMIZATION
A. Optimization Within Prior Art Conditions or Through Routine Experimentation
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
B. There Must Be an Articulated Rationale Supporting the Rejection
In order to properly support a rejection on the basis that an invention is the result of "routine optimization", the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). See also In re Van Os, 844 F.3d 1359,1361,121 USPQ2d 1209, 1211 (Fed. Cir. 2017 ("Absent some articulated rationale, a finding that a combination of prior art would have been ‘common sense’ or ‘intuitive’ is no different than merely stating the combination ‘would have been obvious.’"); Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362, 119 USPQ2d 1822 (Fed. Cir. 2016) ("[R]eferences to ‘common sense’ … cannot be used as a wholesale substitute for reasoned analysis and evidentiary support … .").
The Supreme Court has clarified that an "obvious to try" line of reasoning may properly support an obviousness rejection. In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), the CCPA held that a particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, because "obvious to try" is not a valid rationale for an obviousness finding. However, in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421 ("The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103."). Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
Therefore, it would have been obvious to one having ordinary skill in the art to use between 30 watts and 400 watts as claimed, since clearly the parameters of the sonication (time period, amplitude of the sonication, and how long pulse last administered) are results effective variables.
To use the solution at a concentration of 5 mg/ml to 20 mg/ml would have been obvious to one having ordinary skill in the art in an effort to optimize the desired results since clearly the concentration is a results effective variable.
There is no support in the application for “without digestion”. Applicant points the examiner to paragraph 86, but this does not provide support. In fact, in paragraph 129, enzymatic digestion is performed. While paragraph 86 states that “[s]onication is a rapid process because it does not involve additional digestion” this does NOT provide support for no digestion. Further, it is not clear what “digestion” actually means.
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 MICHAEL V MELLER whose telephone number is (571)272-0967. The examiner can normally be reached M-F 9 am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MICHAEL V. MELLER
Primary Examiner
Art Unit 1655
/MICHAEL V MELLER/ Primary Examiner, Art Unit 1655
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