Prosecution Insights
Last updated: July 17, 2026
Application No. 18/255,010

Liquid Nutritional Compositions with Water-Insoluble Plant Flavonoid and Method of Production Thereof

Non-Final OA §103§112
Filed
May 30, 2023
Priority
Nov 30, 2020 — provisional 63/119,157 +2 more
Examiner
SILVERMAN, JANICE Y
Art Unit
1792
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Abbott Laboratories
OA Round
3 (Non-Final)
36%
Grant Probability
At Risk
3-4
OA Rounds
3m
Est. Remaining
90%
With Interview

Examiner Intelligence

Grants only 36% of cases
36%
Career Allowance Rate
72 granted / 197 resolved
-28.5% vs TC avg
Strong +53% interview lift
Without
With
+53.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
43 currently pending
Career history
247
Total Applications
across all art units

Statute-Specific Performance

§101
1.2%
-38.8% vs TC avg
§103
72.2%
+32.2% vs TC avg
§102
0.7%
-39.3% vs TC avg
§112
1.9%
-38.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 197 resolved cases

Office Action

§103 §112
0otice 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 . DETAILED ACTION 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/16/2026 has been entered. Status of the Claims Receipt of Remarks/Amendments filed on 03/16/2026 is acknowledged. Claim 20 is cancelled. Claims 24-25 are new. Claims 1-2, 12-13, and 18 are amended. Claims 1-19 and 21-25 are presented for examination on the merits for patentability. Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application. Claim Objections Claims 3, 14, and 24 are objected to because of the following informalities: Claims 3, 14, and 24 recites protein to flavonoid weight ratios "from about 5 to about 100”, "from about 5 to about 100”, and "from about 15 to about 25”, respectively. It is requested that the ratios be indicated in the proper convention similar to the written ratios in Claims 12 and 18. Claim Rejections - 35 USC § 112 The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph: 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 and 25 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 introduces new matter as the claim recites the limitation: “wherein the plant flavonoid is not pre-treated with an alkali solution”, which does not appear to have support in either the instant specification and/or claims as originally filed. This limitation was not described in the specification as filed, and a person skilled in the art would not recognize in the applicant's disclosure a description of the invention as presently claimed. The specification discloses “hesperidin is extremely unstable…in the alkali pH range, and decomposition occurs during storage” and “…stabilize hesperidin involves combining it with a specific dihydric alcohol, and a sugar alcohol, wherein the decomposition of hesperidin is suppressed and enables hesperidin dissolution/dispersion without the use of a strong alkali solution (US 8,507,452 B2)” , but does not explicitly describe the instantly claimed limitation, i.e. wherein the plant flavonoid is not pre-treated with an alkali solution, as written. In other words, while Applicant may exclude the step of using an alkali with hesperidin, it does not have support for excluding alkali solution with other plant flavonoids, and does not exclude a pre-treatment step using alkali solution. If Applicant believes this rejection is in error, applicant must disclose where in the specification support for the entire scope of the amendment(s) and/or new claims can be found. From MPEP 2163.06: “Applicant should therefore specifically point out the support for any amendments made to the disclosure.” Applicant has not directed the Examiner to the support in the specification for the amendments. Therefore, it is the Examiner's position that the disclosure does not reasonably convey that the inventor had possession of the subject matter of the amendment at the time of filing of the instant application. All claims depending from Claim 1 would not be interpreted as containing new matter in their own recitations, however, these claims are still rejected as they depend on rejected Claim 1. 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 1-11 and 25 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 rejected for indefiniteness for the recitation of “wherein the plant flavonoid is not pre-treated with an alkali solution”. It is unclear what Applicant means by ‘pre-treated’ in this case because the Specification does not provide any guidance on its definition, i.e. what steps are considered to be the treatment steps. The Specification and Claim 1 only uses the term “treatment” in the context of “heat treatment” or “heat-treated”, however, the claim language recites “wherein the plant flavonoid is not pre-treated with an alkali solution”, which appears to differ from the heat-treatment step. As such, it is unclear if Applicant is only excluding alkali solution treatment of hesperidin before its introduction in the liquid nutritional composition but that addition of alkali solution is allowed during the homogenization etc. However, as noted in the new matter rejection, the Specification only recites that “hesperidin is extremely unstable…in the alkali pH range”, but that there is nothing in the Specification that would guide one of ordinary skill in the art to know what is meant to not pretreat a plant flavonoid with alkali solution. To move prosecution forward, the Examiner will interpret the phrase to mean not mixing alkali solution with hesperidin prior to mixing other components, as appears to be the intention per the Remarks (p. 2, 2nd paragraph, 1st sentence). However, correction is required. Claims 2-11 and 25, which depend from Claim 1 are also rejected. 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 1-4, 6-8, 11-15, 17-19 and 21-25 are rejected under 35 U.S.C. 103 as obvious over Hoebler, P. (Of record) , in view of Sono R. (US 8,507,452 B2), hereinafter Sono, as evidenced by Patel et al. (Of record), hereinafter Patel, and Unlockfood (Of record). Hoebler discloses flavanones-containing food compositions for bone and skin health comprising hesperidin with improved stability (Abstract). Regarding Claims 1, 4, 7, 12, and 15, Hoebler discloses a preparation of a skimmed milk formulation wherein skimmed milk powder is dissolved in water, heated, and mixed, and hesperidin powder introduced (Example 2). Hesperidin reads on the claimed water-insoluble plant flavonoid. Hoebler teaches preparing the potassium hydroxide solution to the hesperidin mix, and then the milk is standardized to pH 6.6-6.9; the mixture is then heated and homogenized at 180 bar at the 1st stage, and 40 bar at 2nd stage (Example 2). The Applicant does not disclose the sequence of the steps and discloses in [00039] that the heat treatment may be conducted before, simultaneous with, or after the high pressure homogenization. Additionally, Hoebler teaches drying the mixture into a powder, and reconstituting into a liquid by dissolving in warm water, indicating a further heating step (Example 2). By the Examiner’s calculation, 180 bar is equivalent to 2600 psi which is within the claimed ranges in Claims 1 and 7. Hoebler teaches mixing hesperidin with alkali solution, which does not meet the requirement of independent Claim 1 “wherein the plant flavonoid is not pre-treated with an alkali solution”. However, the Examiner notes, that this feature is not present in independent Claim 12. Sono also discloses a composition that stably contains hesperidin, wherein hesperidin is stably contained and its decomposition is suppressed, curing the deficiency of Hoebler (Abstract). Sono teaches that hesperidin compositions are useful for producing pharmaceutical, food, and oral compositions, each stably containing hesperidin, in an easy manner (Col. 3, lines 20-25). Sono comprehends that many attempts have been made to increase the solubility of hesperidin using strong alkali solution but noted the problem of decomposition during storage (Col. 1, line 52 to Col. 2, line 8). Sono teaches preparation of viscous liquid compositions by mixing ingredients in Table 2 including hesperidin; without the use of alkali; involve mixing to obtain a homogenous mixture at each step; and pH 6.6 (Production Example 2, Examples 16 and 17). Sono teaches that the hesperidin is uniformly dispersed in the compositions, and that the stability after 3 week storage at 55˚C are 87.4% and 83.1% for Examples 16 and 17 respectively (Production Example 2). PNG media_image1.png 287 440 media_image1.png Greyscale PNG media_image2.png 286 434 media_image2.png Greyscale Because Sono teaches that the stability after 3 week storage at 55˚C are 87.4% and 83.1% for Examples 16 and 17, one of ordinary skill in the art would reasonably expect that the compositions would be stable, i.e. the hesperidin will remain dispersed in the composition at greater than 75%, for 2 months at room temperature. Hoebler teaches its compositions are stable for at least 12 hours [0034]. Sono has taught the application of hesperidin compositions in food, and recognizes the problem with using strong alkali solutions in dissolving hesperidin, teaching hesperidin-containing compositions without the use of alkali solution. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Sono and Hoebler, and prepare a skimmed milk composition for human consumption for bone and skin health comprising the hesperidin composition of Sono, i.e. without alkali to ensure longer stability time, improving upon the method of Hoebler. One would have been motivated to do so with a high expectation of success that the decomposition of hesperidin in the skimmed milk product is suppressed and that the composition would stably contain hesperidin for a longer period of time during storage per the teaching of Sono. Therefore, the claimed invention of the instant application would have been obvious to one skilled in the art at the time of the invention. Further regarding the recitations of “wherein at least 75 wt%…remains suspended…after two months of storage at room temperature” and “wherein at least 85 wt%…remains suspended…after two months of storage at room temperature”, because the prior art as a whole teaches the same composition, the feature of these claims are obvious. Because the prior art composition is the identical composition claimed, the composition must necessarily have the characteristics claimed in Claims 1, 11, 12, and 21. The same applies for the recitations of “wherein upon centrifugation at 30,000xg, 3 hours, the water-insoluble plant flavonoid and protein in each resulting fraction are in a molar ratio of at least about 1.4: 1” and “wherein…are in a molar ratio of at least about 1.7: 1 in Claims 12 and 18. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Additionally regarding the recitations of “wherein at least 75 wt%…remains suspended…after two months of storage at room temperature” and “wherein at least 85 wt%…remains suspended…after two months of storage at room temperature” in Claims 1, 11, 12, and 21 and regarding Claims 12 and 18 recitations of “wherein upon centrifugation at 30,000xg, 3 hours, the water-insoluble plant flavonoid and protein in each resulting fraction are in a molar ratio of at least about 1.4: 1” and “wherein…are in a molar ratio of at least about 1.7: 1”, a 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim." Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1172 (Fed._Cir. 1993). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited."). Note MPEP 2111.04. In this case, Claims 12 and 18 use the term "wherein", rather than "whereby", but it is concluded that the terms should be treated the same ... the wherein clause in these claims merely characterizes the result of what happens when 30,000xg, 3 hours is performed, and does not distinguish the instantly claimed application from the application taught in the prior art. Lastly regarding Claims 12 and 18, these are product-by-process claims, however, patentability is based on the product itself. If the product is the same as a product from the prior art, the claim is unpatentable. The MPEP indicates that the process of making is only relevant "if the process by which a product is made imparts 'structural and functional differences' distinguishing the claimed product from the prior art". See MPEP 2113: "[E]venthough product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). The MPEP also indicates that "the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Gamero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979). "In determining validity of a product-by-process claim, the focus is on the product and not the process of making it." Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1369 (Fed.Cir.2009). The process of making is only relevant "if the process by which a product is made imparts 'structural and functional differences' distinguishing the claimed product from the prior art" Greenliant Systems, Inc. v. XicorLLC, 692 F.3d 1261, 1268 (Fed. Cir. 2012). Regarding the liquid nutritional composition comprising protein, fat and carbohydrate, Hoebler teaches milk in powder that can be reconstituted, and liquid form, inter alia skimmed milk [0051]-[0053]; Skimmed milk comprises protein, fat and carbohydrate as evidenced by Patel (Table 1), which also renders Claims 6 and 17 obvious. PNG media_image3.png 236 476 media_image3.png Greyscale Regarding Claims 2 and 13, Hoebler teaches that 20-30 g of the powder may be mixed with 200-250 mL of liquid to produce a drink according to the invention [0051]. Hoebler expressly teaches a skimmed milk powder formulation contains 1% hesperidin, and teaches reconstitution of 25g powder to reach a final volume of 250 ml, which gives a final concentration of 0.25 g, i.e. 250 mg, of hesperidin in 250 ml volume, falling within the claimed range (Example 2). Regarding Claims 3 and 14, Hoebler does not expressly teach the weight ratio of protein to flavonoid. However, skimmed milk powder comprises a mean wt% of 35.5% protein as evidenced by Patel (Table 1), and Hoebler expressly teaches 1% hesperidin in the skimmed milk powder (Example 2). As such, the ratio is 35.5:1, which is within the claimed 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. See MPEP 2144.05. Regarding Claim 8, Hoebler teaches homogenization at 40 bar at 2nd stage, which is equivalent to 580 psi, and is within the claimed range (Example 2). Regarding Claim 19, skimmed milk inherently contains Vitamin B12 at 1.1-1.4 µg in a 250 mL as evidenced by Unlockfood. One would add water to reconstitute to a liquid composition as Hoebler has taught in Example 2, and adjust the volume according to the desired taste, consistency etc. and therefore also adjust the percentage of Vitamin B12 in the reconstituted product. Regarding Claim 22, Hoebler teaches that its skimmed milk powder formulation contains 1% hesperidin, and teaches reconstitution of 25g powder to reach a final volume of 250 ml, which gives a final concentration of 0.25 g, i.e. 250 mg, of hesperidin in 250 ml volume, falling within the claimed range. The molecular weight of hesperidin is 302.27 g/mol. Therefore, the concentration of the hesperidin is 3.3 mM, which meets the claim requirement; milk does not contain a significant amount of ascorbic acid (Vitamin C), and Hoebler does not teach its addition. By Examiner’s calculation, skimmed milk, which inherently contains Vitamin B12 at 1.1-1.4 µg in a 250 mL as evidenced by Unlockfood, will have very low amount of B12 at 3-4x10-6mM. As such, the cumulative amount of flavonoid and ascorbic acid reads on “not greater than 5 mM”.. Regarding Claim 23, Hoebler teaches skimmed milk powder, which comprises a mean wt% of 35.5% protein, 1% fat, and 51% carbohydrate as evidenced by Patel (Table 1). One would add water to reconstitute to a liquid composition as Hoebler has taught in Example 2, and adjust the volume according to the desired taste, consistency etc. and therefore also adjust the percentage of the protein, fat, and carbohydrate in the reconstituted product. Regarding Claim 24, Hoebler teaches embodiment wherein the food product is a milk powder and the flavanone is 0.5%-5% [0051]. Because skimmed milk powder comprises 34-37% protein as evidenced by Patel (Table 1), the ratio of protein to flavanone overlaps with the claimed ratio. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. See MPEP 2144.05. Regarding Claim 25, Hoebler homogenization at 180 bar, which is equivalent to 2600 psi, and is outside the claimed range (Example 2). However, one of ordinary skill in the art would find it obvious to adjust the pressure used in homogenizing as a matter of experimentation and optimization. The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results. Further, while the exact homogenization pressure is not disclosed by Hoebler, it is generally noted that differences in pressure do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such pressure 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). Given that applicant did not point out the criticality of homogenization pressure of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to determine the optimum homogenization pressure. NOTE: MPEP 2144.05. Claims 5 and 16 are rejected under 35 U.S.C. 103 as obvious over Hoebler in view of Sono, as applied to Claims 1-4, 6-8, 11-15, 17-19 and 21-25 above, and in view of Ramarao et al. (Of record), hereinafter Ramarao. Hoebler is silent on the claimed resveratrol. Ramarao discloses yogurt-based nutritional composition comprising polyphenolic compounds resveratrol, fisetin and quercetin (Abstract). Ramarao teaches that polyphenols resveratrol, fisetin and quercetin have therapeutic and antioxidant properties, which includes the ability to scavenge damaging radicals responsible for the proliferations of unhealthy cells, activates a longevity gene etc. (pp. 5-6). Regarding Claims 5 and 16, Ramarao teaches the steps of preparing a yogurt to comprise heating milk or a mixture predominantly containing milk to a temperature to deactivate the microorganisms or enzymes present, cooling to 35-45°C, and treating with resveratrol, fisetin and quercetin prior to fermentation (p. 7). Ramarao teaches an example of using homogenized or skimmed milk (p. 8). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Ramarao with that of Hoebler and add polyphenolic compounds including resveratrol in the skimmed milk of Hoebler to enhance the benefit of the skimmed milk, as Ramarao has taught that polyphenols including resveratrol have therapeutic and antioxidant properties. Claims 9-10 are rejected under 35 U.S.C. 103 as obvious over Hoebler in view of Sono, as applied to Claims 1-4, 6-8, 11-15, 17-19 and 21-25 above, and in view of Brown, M. (Of record). Regarding Claims 9-10, Hoebler discloses heat treatment at 95° C for 5s in order to get a microbiologically safe product (Example 2). However, Hoebler does not expressly teach this condition as a sterilization step that would extend the shelf life and the disclosure of heat treatment at 95° C for 5s in Example 2 is outside the claimed “from about 70° C to about 80° C for 10 to 25 seconds” or “from about 138° C to about 152° C for at least about 5 seconds”. Brown cures the deficiency by teaching pasteurization and sterilization processes for improving the food and beverage shelf life (Sections 6.1, 6.8.6, 6.8.7). Brown specifically teaches high temperature pasteurization >70-100˚C e.g., pasteurization at 72°C for 15 seconds and 70°C for 6 seconds, which cause reduction in microorganisms (p. 225, 2nd bullet point). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine Brown with Hoebler with reasonable expectations that the heat treatment of Hoebler at 95° C for 5s will sterilize the milk, removing microorganisms, improving its shelf life. The Examiner further notes that Applicant discloses that the specific heating conditions are not critical and various heating processes known in the art may be employed [00039]. As such, one of ordinary skill in the art would find it obvious to adjust the temperature as a matter of experimentation and optimization to achieve been equivalent the optimum shelf-life. The adjustment of particular conventional working conditions is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results. Response to Remarks: Applicant argues that the instant Application differ from Hoebler because Hoebler describes treating hesperidin with an alkali solution prior to mixing with the other components of a food product. The Examiner has considered the argument but found it unpersuasive. The rejection supra now relies on Hoebler modified by Sono as necessitated by the amendment. As discussed above, Sono teaches an improvement in the method of Hoebler to provide a composition comprising hesperidin with longer stability time in storage. Applicant argued that Claim 12, which now recites the Claim 18 limitations, is not a product-by process claim because the molar ratio of water-insoluble plant flavonoid to protein in each fraction of a composition prepared by the method described in the present application (and thus in which the flavonoid protein association is formed) is significantly higher than the molar ratio in each fraction of a composition that is not prepared by the method described in the present application. The Examiner has considered the argument and reiterates that this is a product-by-process claim. Applicant admits that “the molar ratio of water-insoluble plant flavonoid to protein in each fraction of a composition prepared by the method described in the present application…” Regarding the claim that the flavonoid protein is significantly higher than the molar ratio in than if prepared by a different method, Applicant has yet to show a comparison with the closest prior art Hoebler, and to show that the difference is in fact of statistical and practical significance in order to be persuasive. To date, the data presented in Fig. 2 fails to demonstrate that the ratio of protein to flavonoid observed were significantly greater than what would have already been expected by one of ordinary skill in the art at the time of the invention based on the teachings of Hoebler because such comparison is missing. Please see MPEP §716.02(b)[R-2], which states, “The evidence relied upon should establish ‘that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.’ Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992)”. The establishment of a property that is also found in the prior art, i.e. ratio of protein to flavonoid, fails to provide a patentable distinction between the products and, therefore, is insufficient to rebut the evidence of obviousness. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANICE Y SILVERMAN whose telephone number is (571)272-2038. The examiner can normally be reached on M-F, 10-6 EST. 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, Erik Kashnikow can be reached on (571) 270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /JANICE Y SILVERMAN/Examiner, Art Unit 1792
Read full office action

Prosecution Timeline

May 30, 2023
Application Filed
Jul 29, 2025
Non-Final Rejection mailed — §103, §112
Oct 20, 2025
Response Filed
Dec 17, 2025
Final Rejection mailed — §103, §112
Feb 12, 2026
Examiner Interview Summary
Mar 16, 2026
Request for Continued Examination
Mar 20, 2026
Response after Non-Final Action
Jun 30, 2026
Non-Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
36%
Grant Probability
90%
With Interview (+53.3%)
3y 4m (~3m remaining)
Median Time to Grant
High
PTA Risk
Based on 197 resolved cases by this examiner. Grant probability derived from career allowance rate.

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