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
Applicant’s remarks and amendments, filed 16 February 2026 in response to the non-final rejection mailed 19 November 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 16 February 2026 replaces all prior versions and listings of the claims.
Claims 1, 3-5, and 8-10 are pending. Claims 1, 5, and 8 are amended. Claims 1, 3-5, and 8-10 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s amendments to Claim 5 has overcome the claims objection in regards to minor informalities. The objection to Claim 5 has thus been withdrawn.
Claim Rejections - 35 USC § 103
(grounds modified as necessitated by amendment)
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, 3-5, and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Touiss et al. (Physiol Pharmacol, Sept 2019, 197-207), Weidner et al. (Mol Nutr Food Res, 2014, 903-907), Go et al. (Nutrients, 2015, 8532-8544), and Maksimovic et al. (Pharmazie, 2004, 524-527).
The instant claims are as of record, drawn to a method for preventing, improving, or treating diabetes or a method for obtaining the effect of blood glucose reduction comprising administering a composition comprising a combination of lemon balm extract comprising 35-70 mg/g of rosmarinic acid and a corn silk extract comprising 0.5-40 mg/g of allantoin as active ingredients to a subject in need thereof.
Touiss et al. teach that a methanol and n-butanol (lower alcohol having 1-4 carbon atoms; as required for instant Claim 5) extract of Ocimum basilicum comprising 108.02 mg/g of rosmarinic acid (Touiss et al., Results, page 201) administered to high-fat diet induced hyperlipidemic mice (subject in need; as required for instant Claims 1 and 8) at a dose of 200 mg/kg (e.g., 21.6 mg/kg rosmarinic acid; Touiss et al., Materials and methods, page 199) reduced plasma total cholesterol (blood lipid reduction) and liver total cholesterol and triglycerides (fatty liver improvement; Touiss et al., Results, pages 201-202; as required for instant Claims 1 and 8).
Weidner et al. teach that ethanolic (lower alcohol having 1-4 carbon atoms; as required for instant Claim 5) extract of lemon balm contains rosmarinic acid, which is a ligand of peroxisome proliferator-activated receptors (PPARs) that regulate glucose and lipid metabolism (Weidner et al., page 905). Additionally, lemon balm extract administered to insulin-resistant high-fat diet-fed mice reduced hyperglycemia, insulin resistance, plasma triglycerol, nonesterified fatty acids, and cholesterol levels, and could therefore be used to prevent or treat type 2 diabetes (as required for instant Claim 1) and associated disorders such as dyslipidemia (hyperlipidemia) and hypercholesterolemia (Weidner et al., Abstract, page 903; as required for instant Claims 1 and 8). This extract and holistic poly-drug and poly-target approaches can be used to develop functional foods (food composition; health functional food) or nutraceuticals (Weidner et al., page 907; as required for instant Claims 9 and 10).
Go et al. teach that the active component of Dioscorea batatas, allantoin, along with water extracts (as required for instant Claim 5) of D. batatas, exhibits antidiabetic effects by reducing blood glucose levels and increasing serum insulin (Go et al., Discussion, page 8540; as required for instant Claims 1 and 8) when administered to streptozotocin-induced diabetic rats (subject in need thereof; Go et al., 2.2., pages 8533-8534; as required for instant Claims 1 and 8). Allantoin additionally reduced serum levels of low density lipoprotein, high density lipoprotein, and triglycerides (blood lipid reduction; Go et al., Figure 4, page 8537; as required for instant Claim 8) and can modulate lipid profiles, improve liver function, and maintain insulin and glucose levels (Go et al., Conclusions, page 8542). Allantoin was administered at a dose of 2 mg/kg of body weight to achieve these effect (Go et al., 2.3., page 8534).
Maksimovic et al. teach that allantoin is found in Maydis stigma (corn silk) at a range between 215 and 289 mg per 100 g of dry plant material (Maksimovic et al., Table 2, page 526), which converts to 2.15-2.89 mg/g of dry plant material (as required for instant Claims 1 and 8).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the teachings of Touiss et al., Weidner et al., Go et al., and Maksimovic et al. to arrive at the instantly claimed invention. A skilled artisan would be able to substitute plant extracts with the same active ingredients (e.g., lemon balm for Ocimum basilicum and corn silk for Dioscorea batatas) in order to prevent, improve, or treat Type II diabetes and reduce blood lipids particularly with the knowledge that rosmarinic acid is a ligand of PPARs that regulate glucose and reduce plasma cholesterol and allantoin is known to reduce blood glucose levels, increase insulin levels, and reduce blood lipid levels. A skilled artisan would be motivated to use ethanolic (e.g., as in the specification at [46]) lemon balm extract because it is safe for humans and the extract as a whole provides synergistic or additive effects of many compounds found within while avoiding side effects of synthetic PPAR agonists (Weidner et al., page 907). Additionally, a skilled artisan would be motivated to use corn silk as an allantoin source because it is a traditional herbal drug collected after harvesting corn, making it readily available as an agricultural by-product and there are various hybrids available with varying levels of allantoin (Maksimovic et al., Introduction, page 524). Additionally, regarding synergy (as required for instant Claim 4), the prior art indicates that plant extracts as a whole (e.g., extract of corn silk versus allantoin alone) provide synergistic effects and this knowledge combined with the different molecular mechanisms of the active ingredients including rosmarinic acid glucose reduction via PPARs and allantoin antioxidant activity, lipid profile modification, and promotion of GLP-1 release (Go et al., Abstract, page 8532), synergy when combining the two extracts would not be unexpected by a skilled artisan. A skilled artisan could therefore take the knowledge of the positive effects of the active ingredients rosmarinic acid and allantoin regarding diabetes and blood glucose and provide extracts from lemon balm and corn silk which also comprise the same active ingredients to arrive at the instantly claimed invention with a reasonable expectation of success.
Touiss et al., Weidner et al., Go et al., and Maksimovic et al. are relied upon for the reasons discussed above. If not expressly taught by the prior art, based upon the overall beneficial teaching provided by Touiss et al. regarding the dose of rosmarinic acid of 21.6 mg/kg and the teaching provided by Go et al., regarding the dose of allantoin of 2 mg/kg, the adjustments of particular conventional working conditions (e.g., determining one or more suitable rosmarinic-acid containing lemon balm extracts of instant Claims 1 and 8 and weight ratios of lemon balm extract to corn silk extract of instant Claims 1, 3, and 8) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. A skilled artisan could reasonably take the ratio of the active ingredients in the dosages of Touiss et al. and Go et al., resulting in a rosmarinic acid:allantoin ratio of 21.6:2, or 10.8:1, and apply it to lemon balm and corn silk extracts. The range of rosmarinic acid:allantoin as set forth in instant Claim 3 is (35-140):(0.5-40), which overlaps (e.g., 43.2:4) with the dose ranges for rosmarinic acid and allantoin as taught by Touiss et al. and Go et al.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art (including compositions within the process thereof), the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Response to Arguments
Applicant's arguments filed 16 February 2026 have been fully considered but they are not persuasive.
Applicant argues that the diabetes model targeted by the method of Claim 1 is a Type II diabetes model in which a large amount of ineffective insulin is secreted and that it would not be obvious to provide allantoin in conjunction with rosmarinic acid to treat, prevent, or improve Type II diabetes because Go et al. use a Type I diabetes model and allantoin leads to an increase in serum insulin levels. Additionally, applicant argues that the disease models and directions of insulin regulation are complete opposites, mechanisms of action are conflicting, and contradict common knowledge in the field because increasing insulin in a patient with Type II diabetes increases β-cell stress, body weight, and the risk of hypoglycemia.
Insulin, however, is used to control blood sugar in both Type I and Type II diabetics (Medline Plus, 2017, page 1). While there may be some side effects of increased insulin in Type II diabetics, uncontrolled diabetes can lead to serious or life-threatening health complications including heart disease, stroke, kidney problems, nerve damage, and eye problems (Medline Plus, page 2). Additionally, while there are differences between Type I and Type II diabetes, the overall result of high blood sugar due to an insulin deficiency (because the body does not make insulin or makes defective insulin) is still the same and providing insulin (e.g., increasing blood insulin levels) is a known and accepted treatment for both Type I and Type II diabetes (Meline Plus, pages 1-2).
Regarding applicant’s argument concerning synergism for the combination of lemon balm and corn silk extracts for the reduction of serum insulin and blood HbA1c, it is noted that synergism is broadly recited only in dependent Claim 4 regarding treating diabetes and is not a limitation in either independent Claims 1 or 8, nor is it a limitation of the method for obtaining the effect of blood glucose reduction as a dependent claim. Additionally, while evidence of a greater than expected result may also be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately (i.e., demonstrating "synergism"), a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. See MPEP § 716.02(a).
In the instant case, synergism is not necessarily unexpected because the metabolic disease of diabetes comprises a variety of treatments, including but not limited to changes in diet (e.g., consuming beneficial antioxidants such as those in corn silk as described by Wang and Zhao), exercise, weight loss, and medications (e.g., anti-hyperglycemics such as lemon balm extract as described by Chung et al.). Additionally, the prior art indicates that plant extracts as a whole (e.g., extract of corn silk versus allantoin alone) provide synergistic effects and the active ingredients of the claimed extracts each have different mechanisms of action, including rosmarinic acid glucose reduction via PPARs and allantoin antioxidant activity, lipid profile modification, and promotion of GLP-1 release.
Additionally, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., specific mechanisms for treatment in instant Claim 1; reduction of blood HbA1c) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Finally, while the limitation of “a reduction in blood insulin and blood glucose levels” of Claim 8 is free of the art, the generic claim is drawn to one or more effects selected from the group consisting of body weight loss, a reduction in blood insulin and blood glucose levels, blood lipid reduction, and fatty liver improvement. As described in the rejection above, blood lipid reduction is achieved via administration of allantoin (corn silk) and rosmarinic acid (lemon balm) and therefore it remains obvious to combine compounds with the same effects for the same purpose and a skilled artisan could do so with a reasonable expectation of success.
Examiner’s Comment
In the interest of expediting prosecution, please note the following draft claim language (or similar amendment, commensurate in scope with the instant disclosure), considered to distinguish over the grounds of rejection of record. The phrasing as presented below is suggested: to cancel claims 1-7 and 10-14 and to incorporate the limitation of/into Claim 8 (which is free of the art).
In claims 8-9:
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8. A method for reducing blood glucose and blood insulin levels comprising administering a composition comprising a lemon balm extract and a corn silk extract as active ingredients to a patient in need thereof,
wherein the weight ratio of the lemon balm extract to the corn silk extract is 1:2 to 4:1;
wherein the lemon balm extract comprises 35 to 70 mg/g of rosmarinic acid; and
wherein the corn silk extract comprises 0.50 to 40 mg/g of allantoin.
9. The method of claim 8, wherein the composition is a food composition, a pharmaceutical composition, or a health functional food.
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and, in claims 14-17:
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14. The method of claim 8, wherein the composition produces one or more additional effects selected from the group consisting of body weight loss, blood lipid reduction, and fatty liver improvement.
15. The method of claim 8, wherein the weight ratio of the lemon balm extract to the corn silk extract is 1:1 to 2:1.
16. The method of claim 8, wherein the combination of the lemon balm extract and the corn silk extract has a synergistic effect relative to each individual extract.
17. The method of claim 8, wherein the lemon balm extract and the corn silk extract are juice or extracted with an extraction solvent selected from the group consisting of water, a lower alcohol having 1 to 4 carbon atoms, and mixtures thereof.
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Conclusion
No claims are presently allowed.
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 JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 11:00am to 5:00pm EST.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655