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 .
Claim status
The examiner acknowledged the amendment made to the claims on 04/24/2026.
Claims 1, 5-12, 14-15, 17-21, 23-24, 26-27 and 29-30 are pending in the application. Claim 1 is currently amended. Claims 2, 13, 16, 22, 25 and 28 remain cancelled. Claims 3-4 are newly cancelled. Claims 15, 17-21 and 23-24 are withdrawn without traverse in response to the restriction requirement. Rest of claims are previously presented. Claims 1, 5-12, 14, 26-27 and 29-30 are hereby examined on the merits.
Examiner Note
Any objections and/or rejections that are made in the previous actions and are not repeated below, are hereby withdrawn.
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, 5-12, 14, 26-27 and 29-30 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.
Claim 1 recites solubilizing pea protein by mixing the pea protein with an alkali solvent comprising an aqueous solution of 0.05 M to 0.2 M base and having a pH of about 6 to 9. The examiner does not find the support for such a limitation. It is noted that page 4, line 20-26 of the instant specification recites that the pea protein is solubilised either by chemical or physical means in which the former involves mixing the pea protein with alkali to provide an alkali pea protein solution having a pH of 10 or more, and a physical solubilization involves treating a pea protein in an solvent (e.g., an aqueous solvent such as a buffer) at a pH of 6-9 with physical means (e.g., sonication or ultrasonication). Further, Instant specification on page 9 bottom para. clearly recites that alkali solvent means an aqueous solution of suitable base such as NaOH or KOH and one example is 0.05-0.2 M base as recited in instant claim 1. There is no support for solubilization of pea protein in alkali solvent comprising 0.05-0.2 M base having a pH of 6-9.
Claims 5-12, 14, 26-27 and 29-30 ultimately depend from claim 1 and therefore necessarily incorporate the written description deficiency therein.
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, 5-12, 14, 26-27 and 29-30 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 recites an alkali solvent, then recites a pH of 6-9. Since the pH range will encompass a pH range of 6-7, it is unclear how a pH of 6-7 is alkali.
Claims 5-12, 14, 26-27 and 29-30 ultimately depend from claim 1 and therefore necessarily incorporate indefinite subject matter therein.
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, 6-12, 14, 26-27 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Klemmer, "Pea protein‐based capsules for probiotic and prebiotic delivery", International Journal of Food Science and Technology, 2011, 46, pages 2248-2256 (hereinafter referred to as Klemmer) in view of Hayakawa US Patent Application Publication No. 2008/0213758 A1 (hereinafter referred to as Hayakawa), Yuuri JP2007068426 A (English translation relied upon for reference, hereinafter referred to as Yuuri), Lee US Patent Application Publication No. 2012/0161067 A1 (hereinafter referred to as Lee) and Batista, “Accessing gelling ability of vegetable proteins using rheological and fluorescence techniques” 2005, 36, pages 135-143 (hereinafter referred to as Batista) .
Regarding claims 1, 6-8, 11-12, 14, 26-27 and 30, Klemmer teaches a method comprising the steps of (page 2250, left hand column, 1st para.):
- solubilizing pea protein isolate by mixing the pea protein with an alkali solvent;
-heating the pea protein solution at 80 ºC with constant stirring for 30 min; and
- cooling the protein solution to room temperature with water bath.
Klemmer teaches solubilizing pea protein by using alkali solvent thus being silent regarding solubilization by sonication.
Hayakawa teaches a method of dissolving wheat protein by dispersing (e.g., suspending) wheat protein in a phosphate buffer followed by an ultra-sonication step to dissolve the protein ([0094]). Both Klemmer and Hayakawa are directed to dissolving plant proteins. It is found that the Klemmer contains a method of solubilizing protein by alkali solvent which is different from the sonication-assisted solubilization method as recited in claim 1. It is also found that sonication-assisted solubilization of a protein is known in the art (e.g., by Hayakawa). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one known element (e.g., sonication-assisted solubilization in the presence of a buffer) for another (e.g., alkali solubilization), and the results of the substitution would have been predictable, e.g., the sonication will help to dissolve the pea protein. See MPEP 2143. B. Simple Substitution of One Known Element for Another To Obtain Predictable Results.
Where Klemmer as modified by Hayakawa teaches the same method of solubilizing pea protein by sonication, it logically follows that up to 70% pea protein is solubilized. See MPEP 2112.01 I, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Klemmer is silent regarding resting the solubilized pea protein solution for 15 minutes- 2 hours (or at least 30 min as recited in claim 6, or at least 40 min as recited in claim 7, or 15-45 min as recited in claim 26, or 45 min as recited in claim 27) to further solubilize and hydrate the pea protein, and to provide a greater than 90% (w/v) solubilized and rested pea protein.
Yuuri teaches a method of solubilizing (e.g., extracting) pea protein comprising resting (e.g., leaving) the pulverized pea protein in alkali solution for 30 min to solubilize the protein (0028).
As such, before the effective filling date of the claimed invention, it is known to rest a solution that contains pea protein for some duration to solubilize the protein therein.
Both Klemmer and Yuuri are drawn to pea protein. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Klemmer by leaving to stand or resting pea protein in alkali solution for the purpose of solubilizing pea protein.
Regarding the duration of resting the pea protein solution: the duration of resting the pea protein solution is among the general conditions known by one of ordinary skill in the art to affect the proportion of the pea protein that is solubilized, given that solubilization is the interaction between a solute and a solvent. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have manipulated the duration of leaving the pea protein solution to stand so as to obtain a maximum or sufficient solubilization of the pea protein. Therefore, durations of resting as recited in claims recited in the claims 6-7 and 26-27 are merely obvious variants of the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 “Where 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”. (See MPEP 2144.05 II). Given the degree of solubilization for pea protein is a parameter of the resting time, the limitation about greater than 90% (w/v) solubilized pear protein is also obvious over the teaching of the prior art.
Given that prior art teaches the same resting step as that recited in the instant claim, it logically follows that this resting step will hydrate the pea protein.
Where Klemmer teaches a 6% (w/w) pea protein is prepared (e.g., by alkali solubilization; page 2250, left hand column, 1st para.), one of ordinary skill in the art would have been motivated to manipulate the conditions of ultra-sonication and/or resting so as to ensure a pea protein solution with comparable amount of pea protein is obtained by the combination of sonication-assisted solubilization and resting-assisted solubilization. Note that 6% (w/w) pea protein solution is about 6% (w/v) pea protein solution (assuming the density of the solution is 1 g/ml).
Klemmer teaches heating the pea protein solution but is silent regarding heating the pea protein solution under conditions sufficient to heat-denature at least 90% of the pea protein. However, the specification teaches that "conditions sufficient to heat-denature the pea protein without causing gelation of the pea protein solution" means a temperature and time treatment that denatures at least 90%, 95% or 99% of the pea protein present in the solution while maintaining the solution in a form suitable for extrusion (i.e. readily flowable with suitable viscosity). The temperature and times employed may be varied depending on the concentration of the pea protein solution. Thus, for example, when an 8% pea protein solution (w/v) is used, the solution may be treated at a temperature of 80-90°C for 20-30 minutes (specification, page 11, lines 4-12). Example 1 and Example 4 of the specification further disclose heating an 8% pea and a 7% protein solution at a temperature of 85°C for 25 minutes such that the solution can be used for extrusion to prepare a microcapsule (specification, page 14 and page 16-17).
Klemmer as recited above, teaches heating 6% pea protein at 80 ºC for 30 minutes (page 2250, left hand column, 1st para.), the heating condition of which falls within the ranges recited in the specification for denaturing at least 90% of the pea protein while maintaining the solution in a form suitable for extrusion. Further, the 6% pea protein as taught by Klemmer is close to and a little bit lower than 7-8% pea protein as recited in the specification, and will reasonably result in similar or a little bit higher proportion of denatured pea protein under the same heating condition. As such, the heating step of Klemmer will necessarily serve the purpose or effect of heat-denature at least 90% of the pea protein.
Klemmer in view of Hayakawa and Yuuri is silent regarding at least 90% or at least 95% the denatured protein solution is present as a soluble pea protein aggregate. However, since Klemmer in view of Hayakawa and Yuuri teaches the same solubilizing, resting and heating steps as those recited in the instant claim, it logically follows that at least 90% of the pea protein in the pea protein solution as taught by Klemmer in view of Hayakawa and Yuuri will be present as soluble pea protein aggregates if measured by the Shake Flask method.
Klemmer teaches cooling the pea protein solution by water bath, and further teaches a step of mixing the cooled pea protein solution with other components to form a mixture which is then extruded through a needle (page 2250, left hand column, 1st para.; page 2252, left hand column, first para. and Table 1). Klemmer is silent regarding preventing gelation by immediately and rapidly cooling the denatured pea protein solution to accelerate cooling and maintaining the solution in a form suitable for extrusion into microdroplet thereby providing a cooled denatured pea protein solution with a sufficiently low viscosity to permit the cooled denatured pea protein solution to be extruded or sprayed.
Lee teaches that in the process of extrusion through a needle, if the material that is being extruded is in the form of a gel that is too viscous, the material cannot be easily extruded from the syringe and might easily clog the needle and is thus inconvenient in practical operation ([0022]).
Batista teaches that the rate of cooling a denatured pea protein solution affects the gelation formation; in particular, pea protein solution that is not rapidly cooled (e.g., in a rheometer where the temperature drops 0.6 ºC/min) might form gel but if the pea protein solution is cooled in a refrigerator, no gel is formed (page 136, 2.2.1.1 and 2.2.1.3; page 138 right hand column, 3rd para.; page 139, left hand column, bottom para.).
Both Klemmer and Lee are directed to methods of extrusion using a needle/syringe. Both Klemmer and Batista are directed to cooling a denatured pea protein solution. Where Lee teaches that a gel formation that is very viscous cannot be easily extruded from the syringe and might easily clog the needle, Batista teaches that cooling a denatured pea protein at a normal rate might form gel but cooling it in a refrigerator will prevent gelation. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Klemmer by cooling the denatured pea protein solution in a refrigerator. Doing so would have prevented gelling of the pea protein thus the denatured pea protein would have been less viscous and would been suitable for extrusion through a needle. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have started the cooling process immediately after the heating so as to avoid the formation of gel. Where the cited arts in combination teach the same step of rapid cooling the heat-denatured pea protein solution to accelerate cooling, it logically follows that the resulted rapidly cooled denatured protein solution is in a form suitable for extrusion into microdroplets. See MPEP 2112.01 I, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Regarding claim 9, Klemmer teaches that the pea protein comprises a source of pea protein having a purity of 80.01% (page 2249, right hand column, para.1), which falls within the purity value recited in the claim.
Regarding claim 10, Klemmer, as recited above, teaches that the pea protein is pea protein isolate (page 2250, left hand column, 1st para.).
With respect to claim 29, it is noted that claim 29 further limits the pH of the alkali solvent. Given that alkali solubilization is in alternative form with the sonication-assisted solubilization and Klemmer in view of Hayakawa teaches the latter, prior art reads on claim 29.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Klemmer in view of Hayakawa, Yuuri, Lee and Batista as applied to claim 1 above, and in further view of Schweizer US Patent Application Publication No. 2013/0287928 A1 (hereinafter referred to as Schweizer).
Regarding claim 5, Klemmer in view of Hayakawa, Yuuri, Lee and Batista teaches what has been recited above but is silent regarding the pea protein is centrifuged to remove insoluble matter. Schweizer teaches removing insoluble material from a protein solution by centrifugation so as to provide a clarified protein solution for further processing ([0039]). Both Klemmer and Schweizer are directed to processing protein solutions. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Klemmer by including the step of removing insoluble material from the protein solution by centrifugation to provide a clarified protein solution for further processing.
Response to Arguments
Applicant's arguments filed 04/24/2026 have been fully considered but they are not persuasive.
Applicant argues on page 6 of the Remarks that amending claim 1 to introduce a pH of 6-9 for the alkali solvent does not add new matter and finds support.
The examiner disagrees. Applicant is invited to refer to para. 7 of instant office action for examiner’s reasoning that the limitation has written description deficiency.
Applicant argues on pages 7-8 of the Remarks that Klemmer in view of Yuuri, Lee and Batista fails to teach the limitation about an alkali solvent comprising 0.05-0.2 M base having a pH of 6-9.
The argument is acknowledged. Applicant is invited to refer to para. 7 of instant office action for the new matter issue. Further, it is found that Klemmer in view of Hayakawa, Yuuri, Lee and Batista teaches the limitation about solubilization assisted by sonication, which is in alternative form with alkali solubilization.
Applicant argues on pages 8 and 9 of the Remarks that one of ordinary skill in the art would not be motivated to modify Klemmer with Yuuri, since the latter teaches a method of extracting pea protein from raw pea material as opposed to a method of solubilizing “purified” pea protein. Applicant goes on to list other differences between Klemmer and Yuuri.
The arguments are considered but found unpersuasive. Yuuri teaches a method of solubilizing (e.g., extracting) pea protein, thus is reasonably in the same field of endeavor as Klemmer, even Yuuri teaches solubilization of the raw protein and Klemmer teaches purified protein. Further, Yuuri teaches that resting (e.g., leaving) the pea protein in alkali solution will help to solubilize the protein. Therefore, one of ordinary skill in the art would have reasonable expectation of success that resting purified pea protein would also help the solubilization of pea protein. Applicant appears to have focused too much on the differences between Klemmer and Yuuri but have inadvertently overlooked what they have in common.
Regarding Klemmer in view of Lee, applicant agues on page 9 of the Remarks that Lee is not in the same field of endeavor.
It appears that applicant is arguing that Lee is not analogues art. Such an argument is not persuasive. Lee is directed to a method of extrusion a substance using a needle/syringe, which is in line with Klemmer, or the claimed invention. Further, Lee teaches that in the process of extrusion through a needle, if the material that is being extruded is in the form of a gel that is too viscous, the material cannot be easily extruded from the syringe and might easily clog the needle. Such a teaching from Lee is sufficient to advise the skill artisan who works in the field of extruding pea protein that measures should be taken to prevent the formation of pea gel which could clog the needle or syringe.
Regarding Klemmer in view of Batista, applicant argues on page 10 of the Remarks that Batista teaches dispersed protein in demineralized water at a pH of 5.5 which is fundamentally different from the alkali solution descripted in claim 1. Applicant further argues gelation is also dependent on the concentration of pea protein, and Batista teaches away from including a cooling step, as pea protein concentrations of 10% are not expected to gel regardless of the cooling method.
The arguments are considered but found unpersuasive because first, there is no fundamental difference of pH between 5.5 and 6-9, with the lower bound of the latter being very close to 5.5. Further, Batista is cited to teach adopting a rapid cooling rate to prevent gelation as opposed to pH limitation, thus the argument about pH difference is not relevant. Further, the pH of 6-9 has new matter issue (see para. 7 of the instant office action). Further, the pH of 6-9 limits the alkali solubilization, which is merely in alternative form with sonication assisted solubilization. Second, there is no teaching away in Batista, since the reference clearly favors rapid cooling over slow cooling, knowing that the rate of cooling a denatured pea protein solution affects the gelation formation. Third, applicant is reminded that prior art does not teach 10% pea protein, thus the argument about no need to rapidly cool a pea protein having 10% protein therein is irrelevant.
For the reasons set forth above, applicant’s argument on page 10 of the Remarks that the office uses impermissible hindsight is not persuasive, either. Note that applicant has not shed light on which limitation is solely from applicant’s own disclosure but not taught in the cited arts.
Applicant argues on pages 10-11 of the Remarks that the Application in suit clearly identifies the limitations of Klemmer's alginate-based system, which is unsuitable for the formation of the microdroplets defined in Claim 1 as amended herein. Specifically, Klemmer teaches the use of pea protein-alginate mixtures to form larger capsules, not microdroplets. The scale difference is significant, with microdroplets resulting in microcapsules typically ranging in the micrometer scale, in contrast to the much larger capsules described by Klemmer, which are around 2mm in size. In fact, Klemmer explicitly teaches against using pea protein-only compositions, stating that such capsules lack structural integrity (see "Encapsulation" section, page 2250). A skilled artisan would recognize that Klemmer's method requires pea protein-alginate mixtures for capsule formation, whereas the Application in suit specifically obviates the use of alginate and the formation of microcapsules.
The argument is considered but found unpersuasive because applicant is arguing a feature that is not claimed. Claim 1 does not actively recite an extrusion step to form microdroplets of pea protein, rather, claim 1 merely recites that the pea protein solution is suitable for extrusion into microdroplet, as a result of solubilization, resting, heating and rapid cooling. Nor does claim 1 include a negative limitation that excludes alginate. It is further noted that the disclosure as originally filed does not even have the support for such a negative limitation. To this end, applicant is invited to refer to para. 6-7 of the OA issued 11/14/2020 for parent application 15/536,303, in which the examiner submits that the negative limitation that the alginate is not present in the pea protein solution is not sufficiently supported by the disclosure as originally filed.
Conclusion
Pertinent art
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure
CN 101422206A, which teaches a method of solubilizing (e.g., extracting) pea protein from pea raw material, wherein ultrasonication help to solubilize (e.g., extracting) pea protein.
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 CHANGQING LI whose telephone number is (571)272-2334. The examiner can normally be reached 9:00-5:00.
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/CHANGQING LI/Primary Examiner, Art Unit 1791
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