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 .
Election/Restrictions
Applicant's election with traverse of Group II, claims 12-16, in the reply filed on June 4th, 2026 is acknowledged. The traversal is on the ground that "it should be no undue burden on the Examiner to consider all claims in the single application". This is not found persuasive because Group I requires a field of search (inflammatory molecules) not required by groups II and III. Groups II. Claims 1-11 and 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Applicant’s election of "carbamazepine as the antiepileptic drug", and "the traditional Chinese medicine combination comprising scutellaria root, heartleaf houttuymia, indigowoad root, mongolian snakegourd fruit, mulberry leaf, magnolia bark, peppermint herb, fineleaf nepeta, saposhnikovia root, and baked liquorice root as the traditional Chinese medicine combination species" (sic) in the reply filed on June 4th, 2026 with traverse is acknowledged. To clarify, the election of species was drawn to alternative species within individual claims, whereas the applicant’s traversal contended which claims would be examined. Non-elected species regarding the antiepileptic drug and traditional Chinese medicine are withdrawn as being drawn to non-elected species.
The requirement is still deemed proper and is therefore made FINAL.
Claims 12-16 are pending and were examined on the merits.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The priority date is January 5th, 2024.
Information Disclosure Statement
The information disclosure statement (IDS) filed May 5th, 2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because non-patent literature documents 2 and 8 are partly illegible and the examiner was unable to obtain a copy with non-trivial effort, no copy was provided for non-patent literature documents 9 and 10, and there is a misspelling of the term "NEPETA" in the citation of non-patent literature document 9. It has been placed in the application file, but the information referred to therein has not been considered as to the merits for the documents that are both lined-through on the IDS and not cited on the PTO-892. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a). The examiner was able to retrieve legible copies of certain documents cited on this IDS that were either partly illegible or missing among the documents provided by the applicant; these are cited on the PTO-892 form:
Faheem, M.; et al. A comprehensive review on antiepileptic properties of medicinal plants. Arabian Journal of Chemistry 2021, 15, 103478, DOI: 10.1016/j.arabjc.2021.103478
Khan, A. U.; et al. Awareness and current knowledge of epilepsy. Metabolic Brain Disease 2020, 35, 45–63, DOI: 10.1007/s11011-019-00494-1
Xiao, F.; et al. Review of the use of botanicals for epilepsy in complementary medical systems — Traditional Chinese Medicine. Epilepsy & Behavior 2015, 52, 281–289. DOI: 10.1016/j.yebeh.2015.04.050
Kaur, J.; et al. Potential anti-epileptic phytoconstituents: An updated review. Journal of Ethnopharmacology 2021, 268, 113565. DOI: 10.1016/j.jep.2020.113565
Halder, S.; et al. Herbal drugs and natural bioactive products as potential therapeutics: A review on pro-cognitives and brain boosters perspectives. Saudi Pharmaceutical Journal 2021, 29, 879–907. DOI: 10.1016/j.jsps.2021.07.003
Chang, Y.; et al. Albanin A, Derived from the Root Bark of Morus alba L., Depresses Glutamate Release in the Rat Cerebrocortical Nerve Terminals via Ca2+/Calmodulin/Adenylate Cyclase 1 Suppression. J Med Food 2021, 24 (3), 209–217. DOI: 10.1089/jmf.2020.4817
Bhat, J. U.; et al. ANTI-SEIZURE ACTIVITY OF FLOWER EXTRACTS OF NEPETA BRACTAETA IN SWISS ALBINO MICE. EXCLI Journal 2012, 11, 531-537.
Tsai, K. C.; et al. A traditional Chinese medicine formula NRICM101 to target COVID-19 through multiple pathways: A bedside-to-bench study. Biomedicine & Pharmacotherapy 2021, 133, 111037. DOI: 10.1016/j.biopha.2020.111037
The information disclosure statement (IDS) submitted on December 31st, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on May 14th, 2024. These drawings are acceptable.
Specification
The disclosure is objected to because of the following informalities: the recited term "houttuymia" is a misspelling of "houttuynia", and the.
Appropriate correction is required.
The use of the terms Sprague-Dawley, Waters, Cosmosil, Merck, Pinnacle Technology, and Cheetah, each of which is a trade name or a mark used in commerce, has been noted in this application. Each term should be accompanied by the generic terminology; furthermore, each term 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.
The applicant’s assistance is requested in reciting any trademarks or tradenames they become aware of according to the guidelines above, even if such marks or names are not explicitly pointed out by the examiner.
Claim Objections
Claims 12 and 14 are objected to because of the following informalities: the recited term "houttuymia" is a misspelling of the term "houttuynia". Appropriate correction is required.
Claim 1 objected to because of the following informalities: the. Appropriate correction is required.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The applicant has explicitly defined the terms “prevent,” “preventing,” or “prevention” as “avoiding or delaying the onset of symptoms associated with a disease or condition in a subject who has not developed such symptoms at the time of administering an agent or a pharmaceutical combination commences” (instant specification, paragraph [0034]). Therefore, the terms “prevent,” “preventing,” or “prevention” are interpreted as avoiding or delaying the onset of symptoms as recited above, not preventing the symptoms in an absolute sense. Claims 1 and 17, and claims depending therefrom, refer to preventing, but currently examined claims 12-16 do not claim preventing. Therefore, a 112(a) scope of enablement rejection was not made for claims 12-16, because there was no reference to preventing.
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.
Claim 16 is 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. It is unclear what the term “intervals” encompasses. For instance, it is unclear what period of time there is in an interval, and what administration patterns are encompassed by an interval.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claims 12 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tsai et al. (Biomedicine & Pharmacotherapy 2020, 133, 111037), abbreviated “Tsai”.
When reading the preamble of claim 12 in the context of the entire claim, the recitation "of reducing the dosage of an antiepileptic drug used by a patient with epilepsy" is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Tsai recites the administration of the traditional Chinese medicine NRICM101 to patients: “In medical centers designated to respond to COVID-19, some patients who remained in isolation wards without improvement were administered Taiwan Chingguan Yihau (NRICM101), a traditional Chinese medicine (TCM) formula prescribed and prepared by the in-house TCM departments” (Introduction, paragraph 2; instant claim 12).
Tsai recites the preparation of NRICM101 by combining certain botanical materials and boiled in water: “The decoction of NRICM101 was prepared by the TCM pharmacies in the two medical centers, after slightly modifying the formula for mild cases included in the TCM Treatment Guideline for COVID-19 developed by NRICM (Supplementary 1). It consisted of 10 herbs: Scutellaria Root (Scutellaria baicalensis, HA, 18.75 g), Heartleaf Houttuynia (Houttuynia cordata, HC, 18.75 g), Mulberry Leaf (Morus alba, NB, 11.25 g), Saposhnikovia Root (Saposhnikovia divaricata, NC, 7.50 g), Mongolian Snakegourd Fruit (Trichosanthes kirilowii, ND, 18.75 g), Indigowoad Root (Isatis indigotica, NE, 18.75 g), baked Liquorice Root (Glycyrrhiza glabra, NG, 7.50 g), Magnolia Bark (Magnolia officinalis, NK, 11.25 g), Peppermint Herb (Mentha haplocalyx, NL, 11.25 g), and Fineleaf Nepeta (Nepeta tenuifolia, NR, 11.25 g). For a patient’s daily dose, a full set of herbs and 1 L of water were placed in a boiler, boiled and simmered for the decoction to reduce to 300 mL” (Subheading 2.2 Preparation and composition of the formula; instant claims 12 and 14). Furthermore, it is not clear that the boiling of the botanical materials recited by Tsai is a materially different from the instantly recited method: “the traditional Chinese medicine combination is processed with water and extracted” (the extraction of botanical materials is broadly understood to involve contacting them with a solvent such as water) (instant claim 12). The mass ratios implied by the masses recited by Tsai for each botanical material are interpreted as interchangeable with weight ratios, as each botanicals material is understood as present in the same gravitational environment (instant claim 14).
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.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Tsai et al. (Biomedicine & Pharmacotherapy 2020, 133, 111037), abbreviated “Tsai”.
The cited teachings of the prior art reference Tsai, relevant to claims 12 and 14, are of record above.
Claim 13 recites “The method of claim 12, wherein the traditional Chinese medicine combination is further dried into pow[d]er form”.
Although Tsai does not explicitly recite drying the traditional Chinese medicine into powder form before administering the composition to a patient, one of skill in the art would have been motivated to dry the composition to decrease its mass and volume for more convenient storage. One of skill in the art would have had a reasonable expectation of success at drying the composition into powder form by means of freeze-drying, a method disclosed by Tsai for drying a decoction that meets the composition recited in Claim 12 (Tsai, subheading 2.3. HPLC analysis of NRICM101; instant claim 13).
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kaur, et al. (Journal of Ethnopharmacology 2021, 268, 113565), abbreviated "Kaur"; and further in view of Xiao et al. (Epilepsy & Behavior 2015, 52, 281–289), abbreviated Xiao; Oh et al. (US 9861674 B2), abbreviated "Oh"; Fan (CN 101703280 A); Lv and Li (CN 105213664 A); Chang, et al. (J Med Food 2021, 24 (3), 209–217), abbreviated "Chang", Gupta et al. (Pharmacognosy Research 2014, 6 (2), 188-189); Fu and Fu (CN 107638490 A), abbreviated "Fu"; and "What types of antiepileptic drugs are there?" (Foreign Patent document Cite No 16 on the IDS received on December 31st, 2025)
Claim 15 recites “The method of claim 12, wherein the antiepileptic drug is at least one selected from the group of consisting of phenytoin, carbamazepine, lamotrigine, felbamate, benzodiazepines, tiagabine, and vigabatrin”. Claim 16 recites: “The method of claim 12, wherein the traditional Chinese medicine combination and the antiepileptic drug are administered to the patient simultaneously, sequentially or at intervals”.
The prior art discloses materials having antiepileptic activity, or comprising formulas for treatment of epilepsy:
Scutellaria root, specifically a constituent, the polar organic compound baicalin having anticonvulsant effects (Xiao, Table 1 and subheading 3.2. Scutellaria baicalensis (huangqin); Kaur, Table 1);
heartleaf Houttuynia (Houttuynia cordata), specifically its water extract (Oh, claims 1 and 3);
indigowoad root (radix isatidis/indigo root/dyers woad root, Lv and Li machine translation page 3 of 4, lines 16-20 from the bottom);
snakegourd fruit (Trichosanthes), including the seeds (Fan, CN 101703280 A, Description, under the subheading “Two, background technology”);
mulberry leaf (Morus alba), (Gupta, pages 188 and 189);
magnolia bark (Faheem; Table 2 discloses medicinal plants used traditionally for the treatment of epilepsy, including an ether extract of Magnolia officinalis bark; Table 3 recites principal phytoconstituents of Magnolia officinalis effective in epilepsy treatment, the amphiphilic organic compounds magnolol, honokiol, magnaldehyde, magnatriol B, randaiol, and obovatol);
peppermint herb (Mentha haplocalyx) has been used in a formula for treatment of epilepsy (Xiao, Table 2), Kaur recites Mentha spicata L. (a closely related species) leaves used for anti-seizure effects in folk medicine (Table 1);
fineleaf nepeta (Nepeta bractaeta) (the antiepileptic effects recited by Bhat, Abstract);
saposhnikovia root (Fu, Description, invention content, paragraph 5, recites divaricate saposhnikovia root capable of relieving convulsion, a broadly known symptom of epilepsy, and relieving epilepsy);
Baked liquorice root (Glycyrrhiza glabra root) (use for epilepsy treatment recited by Faheem, Table 2 and use in epilepsy therapy recited by Xiao, Table 1); Khan explicitly discloses: “One of the recent study confirmed that the Glycyrrhiza glabra flavonoid extract possesses defensive property on seizure-induced cognitive impairment and death of neural cells via its antioxidative activities” (Khan, page 52 left column, under subheading Glycyrrhiza Glabra).
One of skill in the art would have been motivated to combine to teachings of the cited references to make a composition for treating epilepsy, including the symptom of convulsion, in a subject by administering the composition to the subject. One of skill in the art would have had a reasonable expectation of success at making such a composition by combining the botanical materials recited in the prior art references. One of skill in the art would have had a reasonable expectation of success at administering the extract to a subject through oral delivery.
Considering the teachings of the prior art summarized above, one of skill in the art would expect the extract recited in claim 12 to have anti-epileptic activity. One of skill in the art could have combined the extract recited in claim 12 with an anti-epileptic drug carbamezipene for treating focal seizures (“What types of antiepileptic drugs are there?”, page 2), implying simultaneous administration, with the predictable effect of decreasing epilepsy symptoms, including convulsion. In this combination, the extract recited in claim 12 and carbamezipene merely perform the same function that they do separately: decreasing the symptoms of epilepsy, including convulsion (instant claim 15 and 16). The dosage of the carbamezipene and the composition recited in claim 12 are obvious over routine optimization. One of skill in the art could adjust the dosages mass of either component using an analytical balance, administer the dosage to a subject in a pentylenetetrazol-induced convulsion model, and observe the effects of the administration on convulsion incidence, onset time, and duration (Gupta, pages 188-189), to compare the effects of different dosages (claim 15, incorporating the limitations of claim 12).
Relevant and Prior Art Made of Record
The relevant and/or prior art made of record and not relied upon is considered pertinent to applicant's disclosure, including the following:
Rabiei, Z. Anticonvulsant effects of medicinal plants with emphasis on mechanisms of action. Asian Pacific Journal of Tropical Biomedicine 2017, 7 (2), 166-172. DOI: 10.1016/j.apjtb.2016.11.028
In Table 1, Rabiei recites antiepileptic medicinal plants or compounds of plant origin, including Trichosanthes dioica Roxb fruits aqueous extract, recited as having “Activity against generalized tonic-clonic and cortical focal seizures”.
Xie, G. (CN 107496698 A) recites “divaricate saposhnikovia roots having the effects of expelling pathogenic wind from the body surface and relieving convulsion and spasm are also used” (Abstract), implying that divaricate saposhnikovia roots relieve the convulsion symptom of epilepsy.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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