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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/11 has been entered.
Election/Restrictions
Species ii (claims 6-7) is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/12/2025.
Response to Amendment
The amendment filed on 8/11/2026 has been entered. Claim(s) 15 is/are currently amended. Claim(s) 1, 4-5, 8-10, 14, 16-30 and 34 has/have been cancelled. Claim 35-37 are new. Claims 2-3, 6-7, 11-13 and 31-33 are depending on claim 15. Claim(s) 2-3, 6-7, 11-13, 15, 31-33 and 35-37 is/are pending with claim(s) 6-7 withdrawn from consideration. Claim(s) 2-3, 11-13, 15, 31-33 and 35-37 is/are under examination in this office action.
Response to Arguments
Applicant's argument filed on 8/11/2026, with respect to 102 rejection has been fully considered but is not persuasive.
Applicant argued that Garcia does not teach the claimed (c) subjecting the plant-based protein hydrogel to a high-shear treatment to fragment the plant-based protein hydrogel into hydrogel fragments, thereby forming a plant-based protein hydrogel slurry comprising the hydrogel fragments, the hydrogel fragments having a d50 of 50 microns or less.
In response, Garcia teaches that by applying mechanical agitation, the protein gels return to liquid form [0113]. The soy protein hydrogel prepared in Example 2 was re-suspended in a 50% v/v ethanol-aqueous solution and left under constant agitation [0213]. The examiner believes that applying mechanical agitation to a gel will break the gel and form fragments. This is supported by Garcia’s disclosure that mechanical agitation “disrupts large colloidal protein aggregates into smaller ones”, and the size of the protein aggregates can be significantly reduced to particle sizes below 200 nm [0100]. Even though paragraph [100] concerns disruption of protein aggregates before hydrogel formation, applying mechanical agitation after gel formation should have the same effect of breaking down the gel into fragments. In Example 2, centrifugation (1000 rpm) is applied only after mechanical agitation (100 rpm) [0213]. This 100 rpm mechanical agitation is the same mechanical agitation as described in paragraph [0100]. Therefore, fragments of particle sizes below 100 nm are expected from agitation of the gel in Example 2.
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 2-3, 11-13, 15, 31-33 and 35-37 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.
The term “high-shear treatment” in claims 15 and 35 is a relative term which renders the claim indefinite. The term “high-shear treatment” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what shear rate (e.g. rpm) is considered high shear. For the purpose of further examination, based on the broadest reasonable interpretation, a shear treatment at any shear rate will be considered meeting this limitation.
Claims 2-3, 11-13, 31-33 and 36-37 are rejected likewise as depending on claim 15.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 2-5, 11-13, 15, 31-33 and 35-36 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Garcia et al (US 20220169858 A1).
Regarding claims 15 and 2-5, Garcia teaches a method for preparing a soy protein hydrogel comprising adding the plant-based protein into a solvent system, wherein the solvent system comprises two or more miscible co-solvents as defined herein [0077]. The first co-solvent increases solubility of the plant based protein(s) and includes an organic acid [0078-0080]. The second co-solvent has decreased solubility of the plant based protein(s) and includes water [0081-0082]. The protein solution is heated such that the liquid solution is held above the sol-gel transition for the protein(s) [0087], and then reduced to a second temperature below the sol-gel transition temperature to facilitate formation of the hydrogel [0090].
The examiner submits that the above process reads on the claimed steps (a) and (b) in step (1).
Garcia teaches that by applying mechanical agitation, the protein gels return to liquid form, enabling unique manufacturing capabilities [0113]. The soy protein hydrogel prepared in Example 2 was re-suspended in a 50% v/v ethanol-aqueous solution and left under constant agitation [0213]. The mechanical agitation disrupts large colloidal protein aggregates into smaller ones, and the size of the protein aggregates can be significantly reduced to particle sizes below 200 nm [0100] (which meets the claimed fragments having a d50 of 50 microns or less). This reads on the claimed high-shear treatment step (c) in step (1), as evidenced by the applicant [P3L32-34, spec.].
Garcia further teaches that the solvent of the hydrogel can be exchanged [0119] or evaporated [0120]. This will reduce the level of at least one and likely both solvents, thus meeting claimed step (2).
Regarding claim 11, Garcia teaches adjusting the pH of the hydrogel from pH=2 to pH=10 with NaOH [0207, 0244, 0250]. NaOH meets the pH-modification material in the instant application as evidenced by the applicant [P19L27, spec.].
Regarding claim 12, Garcia teaches that the composition comprises plasticizer [0122].
Regarding claim 13, The recited viscosity is a property of the product. “Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)). See MPEP 2112.01. Since the prior art teaches the same product as the current invention, the recited property is expected to be present.
Regarding claims 31-32, Garcia teaches a plant-based structured material which can be a food or pharmaceutical film or coating [0023, 0136].
Regarding claim 33, Garcia teaches that the plant based materials have a protein secondary structure with at least 40% intermolecular β-sheet [0104].
Regarding claim 35, Garcia teaches that the solvent exchange can be carried out after formation of the hydrogel but may be carried out after the hydrogel has been formed into a structured material (e.g. after step b) or c) of the method [0119]. This step is before the breaking down the hydrogel into fragments.
Regarding claim 36, the recited “the d50 of the hydrogel fragments is determined by dynamic light scattering” and “by laser diffraction” are methods of particle size measurement, which do not gain patentable weight as long as the prior art teaches the same particle size. Garcia teaches particle size of 200 nm as stated above, which is well below the claimed less than 500 nm. Different measurement methods may lead to certain difference in particle size values; but the examiner does not expect the difference will exceed 300 nm. Besides, Garcia does teach Dynamic light scattering (DLS) [0174].
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garcia et al (US 20220169858 A1).
Regarding claim 37, Garcia teaches the method according to claim 15. Garcia teaches particle size of 200 nm for the hydrogel fragments as stated above, which is sufficiently close to the claimed lower limit of 300 nm that one of ordinary skill in the art would prima facie expect the hydrogel particles based on these particle sizes to have the same properties. It would have been obvious to one of ordinary skill in the art at the time of filing to make particle size within the claimed range based on the close proximity to the prior art range and the reasonable expectation of obtaining a product having the same properties. A prima facie case of obviousness exists where the claimed ranges do not overlap with the prior art but are merely close (MPEP 2144.05.I).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANGTIAN XU whose telephone number is (571)270-1621. The examiner can normally be reached Monday-Thursday.
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, Robert Jones can be reached on (571) 270-7733. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIANGTIAN XU/Primary Examiner, Art Unit 1762
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