DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant's election with traverse of Group II, Claims 10-17 and the species of IRS mediated disease or condition of pre-diabetes in the reply filed on 3 September 2026 is acknowledged. The traversal is on the grounds that the requirement will be withdrawn upon finding of an allowable genus and that any species withdrawn will be transferred to the elected subject matter unless it is found patentably distinct from the elected or allowed claims. This is not found persuasive because it does not address the substance of the restriction requirement set forth in the office action dated 3 April 2026.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
Applicant’s remarks and amendments, filed 3 September 2026 in response to the restriction requirement mailed 3 April 2026, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 3 September 2026 replaces all prior versions and listings of the claims.
Claims 10-15 are pending. Claims 1-9, 16, and 17 are canceled by Applicant’s amendment. Claims 10, 11, 14, and 15 are amended. Claims 10-15 are being examined on the merits.
Specification
The disclosure is objected to because of the following informalities:
At [0050], a close parenthesis is missing from the sentence at lines 5-7;
[0059] and [0062] have the same “IAA” abbreviation, but different meanings, and correction is necessary to distinguish the two;
at [0067], “Insulin Equivalent Units” are abbreviated as IEq, however at [0070] line 7, this unit is abbreviated as IE and appropriate clarification or correction is necessary to maintain consistency throughout the disclosure;
Appropriate correction is required.
The use of the product names and/or companies at [0044]-[0045] (e.g., KitchenAid®), which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112, first paragraph – written description
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 10-15 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.
Claims 10, 11, 14, and 15 recite the limitation “a botanical extract that provides at least 1x104 Insulin Equivalent units in 1 milliliter,” however it is not clear from the instant specification how to determine which botanical extracts have this property without extensive laboratory testing. Table 2 indicates plants which “scored positively” regarding insulin-like activity, however with the values provided in Tables 1 and 2, it is not possible to determine the Insulin Equivalent units in 1 milliliter. At [0069], it is indicated that it is necessary to know the amount of extract which increases the growth of the IRS2 overproducing 32D cell line in order to calculate units of Insulin Equivalent Activity. While [0049] indicates that 1 microliter of extract was used, two different methods for preparing said 1 microliter are provided: aqueous extract derived from 250 g fresh plant material in 1 L of water OR 1 microliter of 5 mg of powdered extract derived from 250 g fresh plant material in 1 L of water dissolved in 1 mL of water. These are not comparable, because the concentrations used are different (e.g., 250 g/L or 250 mg/mL versus 5 mg/mL). Without knowing which concentration was used with which plant, it is not possible to calculate the Insulin Equivalent units for individual plants. It is additionally stated at [0073] that there is no limitation intended on the type of plant extract or purified compound that is capable of producing this activity and that this activity must be identified using the IRS2 overproducing test cells described within the instant specification. Considering this would include not only the over 380,000 plant species on the planet, but also any extract obtained from said plants, using any solvent, and any purified compound from said plants, a skilled artisan would be unable to determine whether the inventors had possession of the claimed invention at the time the application was filed.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under 35 U.S.C. § 112, first paragraph for the reasons set forth above.
Claim Rejections - 35 USC § 112, first paragraph – scope of enablement
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 10-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
The specification, while being enabling for a method for treating an IRS mediated disease or condition (instant Claims 10-13; e.g., the elected condition of pre-diabetes) or stimulating IRS2-dependent signal transduction (Instant Claims 14-15) comprising administering an effective amount a pharmaceutical composition comprising aqueous extracts (see e.g., [0044]) of Cichorium endivia var. latifolium, Lactuca sativa var. crispa, and Lactuca sativa var. longifolia (see e.g., claims of 5/15/2024, Claims 4-6), does not reasonably provide enablement for a method for treating an IRS mediated disease or condition or stimulating IRS2-dependent signal transduction comprising administering an effective amount a pharmaceutical composition comprising any botanical extract from any of the 380,000+ plants on earth using any solvent. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112(a) (AIA ), or 35 U.S.C. 112, first paragraph (pre-AIA ), have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary (see MPEP 2164.01(a)).
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method for treating an IRS-mediated disease or condition (e.g., the elected condition of pre-diabetes) comprising administering an effective amount of a pharmaceutical composition comprising a botanical extract that provides at least 1x104 Insulin Equivalent units in 1 milliliter. Thus, the claims taken together with the specification imply that consumption of a raw plant (e.g., Figures 2A, 3, and 4) or any extract of any plant using any solvent and provided at any concentration which provides at least 1x104 Insulin equivalent units in 1 milliliter (calculated as described in [0049] and [0069]) in a therapeutically effective dose will treat pre-diabetes.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
The prior art indicates that various herbal antidiabetic remedies were known prior to the time the invention was made for their antidiabetic properties, including lowering blood glucose (Khan et al., J Pharm Bioallied Sci, 2012, pg. 27-42), and specifically extracts of chicory (e.g., Cichorium endivia) were known for reduction or limitation of pre-diabetes (Chapal et al., US20140302180 A1, effective filing date 19 November 2012). Additionally, the art eight years after the filing of the instant application indicates that many bioactive secondary metabolites of plants are candidates as antidiabetic agents, however further research to validate and optimize targets, animal models, toxicity, efficacy, pharmacokinetics, and clinical trials remain necessary (Shehadeh et al., Molecules, 2021, Conclusion, pg. 38)
Since use of plant extracts for treatment of prediabetes and their clinical efficacy remains largely unsolved, means for determining which specific plant extracts or components thereof extractable with which solvents at which doses is highly unpredictable.
(5) The relative skill of those in the art:
The relative skill of those in the art is high, with respect to specific plant extracts which may be useful for treating prediabetes in general. However, knowledge of prediabetes-treating properties and mechanisms thereof remained unresolved for all known plants, extracts, and isolated components thereof and beyond the purview of one of skill. Accordingly, one would have turned to the instant disclosure for additional direction and guidance.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided data regarding the IRS2-stimulating activity of various plant extracts at one of two concentrations (however, as described above, the specific concentration used for each extract is unknown) and the increase in growth of 32D test cells relative to control cells (Tables 1 and 2). Additionally, data is provided regarding the effect of consuming 75 g of raw Cichorium endivia var. latifolium or Lactuca sativa var. crispa on fasting blood glucose of a healthy subject, and the effect of consuming 1.9 g of lyophilized aqueous extract of Cichorium endivia var. latifolium on fasting blood glucose of a healthy subject (Figures 2-4). However, the specification does not provide data regarding the effect of extracts of all plants using all solvents on fasting blood glucose or IRS2-dependent signal transduction.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Khan et al., Shehadeh et al., and Chapal et al., and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to test all extracts using all solvents at all concentrations of all plants on the planet using the specific method provided in the instant specification to determine which provide the claimed effects and have at least 1x104 Insulin Equivalent units in 1 milliliter.
It is the Examiner’s position that one skilled in the art could not practice the invention commensurate in the scope of the claims without undue experimentation.
Claim Rejections - 35 USC § 112, second paragraph
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 10-15 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.
Claims 10, 11, 14, and 15 recite the limitation “at least 1x104 Insulin Equivalent units in 1 milliliter,” however is it unclear what the milliliter references (e.g., of extract, of solution, of the composition, etc.).
Claim 11 recites the limitation “the nutritional supplement.” There is insufficient antecedent basis for this limitation in the claim.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under 35 U.S.C. § 112, second paragraph for the reasons set forth above.
Claim Rejections - 35 USC § 102/103
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 the appropriate paragraphs of pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 10-12, 14, and 15 are rejected under 35 U.S.C. 102(e) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Chapal et al. (US 20140302180 A1, effectively filed 19 November 2012) as evidenced by Ihara et al. (Kobe J Med Sci, 2023, E1-E8).
MPEP § 2112 provides guidance as to the Examiner' s burden of proof for a rejection of claims under 35 U.S.C. 102 or 103 based upon the express, implicit, and inherent disclosures of a prior art reference. The case law clearly states that something which is old does not become patentable upon the discovery of a new property.
The instant claims are as of record, drawn to methods for treating pre-diabetes or stimulating IRS2-dependent signal transduction comprising administering to a subject or contacting a cell with an effective amount of an aqueous extract of Cichorium endivia var. latifolium, Lactuca sativa var. crispa, or Lactuca sativa var. longifolia.
Chapal et al. teach administration of a chicory leaf extract (botanical extract; plants of the Cichorium endivia species, e.g., including all varieties; Chapal et al., [0045]) at a dose of 200 mg/kg of body weight (effective amount) for reduction of hyperglycemia, hyperinsulinemia, and insulin resistance in pre-diabetic mice (contacting a cell; IRS mediated disease or condition; pre-diabetes; Chapal et al., [0209]; as required for instant Claims 10-12, 14, and 15). The extract may also be present in a pharmaceutical composition (Chapal et al., [0021]; as required for instant Claim 10) or dietary or nutraceutical (nutritional) supplement (Chapal et al., [0020]; as required for instant Claim 11).
Chapal et al. do not explicitly teach stimulation of IRS2-dependent signal transduction or wherein the botanical extract has at least 1x104 Insulin Equivalent units in 1 milliliter. The extract of Chapal et al., however, is prepared by contacting crushed fresh, blanched, or dried plant material with an aqueous solvent and then evaporating the filtrate to obtain a dried extract (Chapal et al., [0069]-[0090]). This extraction method results in an aqueous extract obtained in the same manner as presented in the instant application (see e.g., [0044]-[0045]) wherein aqueous and organic extracts of fruits, leaves, stems, and roots were obtained by contacting ground fresh plant tissue with water (e.g., aqueous solvent) and drying via lyophilization. In addition, Ihara et al. disclose that chlorogenic acid (e.g., found in the extract of Chapal et al., see e.g., [0051]) increases (stimulates) IRS2 expression (Ihara et al., Fig. 2A, pg. E3).
The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not the aqueous extracts of the prior art and the instant invention are the same. The single-step method of administration of an aqueous extract of species of Cichorium endivia (including the two varieties thereof) are the same, and thus the properties of providing at least 1x104 Insulin Equivalent units in 1 milliliter and stimulating IRS2-dependent signal transduction are inherent, especially in the absence of evidence to the contrary. See MPEP §§ 2112-2112.02.
The cited art taken as a whole demonstrates a reasonable probability that the methods and compositions used therein of the instant invention and the prior art are either identical or sufficiently similar to the claimed method that whatever differences exist, they are not patentably significant.
Consequently, the claimed process (and compositions provided therein) appears to be anticipated by the reference. In the alternative, even if the process (and compositions therein (with respect to an intended therapeutic effect against pre-diabetes and IRS2-dependent signal transduction) is not identical to the referenced process, with regard to some unidentified characteristics, the differences between that which is claimed and that which is disclosed, is so slight that the referenced composition is likely to inherently possess the same characteristics of in the claimed process, particularly in view of the similar characteristics which they have been shown to share (e.g. the similar component materials/formulations and the same broad administration). Thus, the claimed process (and administered-composition effects intrinsic thereto) would have at least been obvious to those of ordinary skill in the art within the meaning of 35 USC § 103(a).
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
Claims 10-15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chapal et al. (US 20140302180 A1, effectively filed 19 November 2012) as evidenced by Ihara et al. (Kobe J Med Sci, 2023, E1-E8) as applied to Claims 10-12, 14, and 15 above, and further in view of Dugi (US 20110301182 A1).
The instant claims and teachings of Chapal et al. as evidenced by Ihara et al. are as of record.
Chapal et al. as evidenced by Ihara et al. do not teach wherein the method further comprises administering an antidiabetic agent, insulin, metformin, exenatide, vildagliptin, sitagliptin, a DPP4 inhibitor, meglitinide, exendin-4, liraglutide, or a GLP-1 agonist.
Dugi teaches a composition comprising a DPP4-inhibitor as well as metformin may be administered to treat pre-diabetes in a subject in need thereof (Dugi, [0001]; as required for instant Claim 13).
It would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify the method of Chapal et al. to include the metformin and/or DPP4-inhibitor of Dugi because metformin is the drug of choice for first-line antidiabetic therapy (Dugi, [0007]) and that dual or triple combination treatments may become necessary for glycemic control (Dugi, [0010]). A skilled artisan would therefore be motivated to include known antidiabetic drugs in the claimed method and could also provide combination treatments with a reasonable expectation of success because they are already known and used in the art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 10-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-7 of U.S. Patent No. 11/633,446 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the single-step method of administering an effective amount of a pharmaceutical or nutritional composition to a subject is the same in ‘874 Claims 10 and 11 and ‘446 Claims 1, 5, and 7. Additionally, the botanical extract which provides at least 1x104 Insulin Equivalent units in 1 milliliter of ‘874 Claims 10, 11, 14, and 15 overlaps with the species of Cichoria endivia and Lactuca sativa (see e.g., Tables 1 and 2 in both disclosures) of ‘446 Claims 1, 5, and 7. Additionally, ‘446 Claim 6 indicates that the extracts provide greater than 3.6×104 Insulin Equivalent units in 1 milliliter, which overlaps the instantly claimed amount. The intended effects (IRS mediated disease or condition, IRS-2 signal transduction) are therefore the same because the same composition is being administered to a subject and/or contact with cells, and the broad claims of ‘874 do not exclude the additional extracts, amounts, or dosage forms of the ‘446 patent claims (see e.g., instant specification [0072], [0098], [0141], [0142]).
Additionally, instant Claims 12 and 13 are identical to ‘446 Claims 2 and 3.
Conclusion
No claims are currently allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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