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 .
This office action is in response to the amendment filed on April 13th, 2026. The applicant
has canceled claims 2-5. Claims 1 and 6-10 are pending and are under examination. Any objections or rejections not reiterated below are hereby withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Withdrawal of Objections and Rejections
Applicant’s arguments filed April 13th, 2026, with respect to objections to the drawings have been fully considered and are persuasive. The objection to the drawings has been withdrawn. Upon further consideration, the drawings received on January 24th, 2024 are of sufficient resolution to distinguish oral ulcers from non-ulcerous oral tissues, despite these drawings being in grayscale.
The rejection of claim 5 under 35 U.S.C. 112(b) is withdrawn, claim 5 having been cancelled by the applicant.
The rejection of claim 5 under 35 U.S.C. 101 is withdrawn, claim 5 having been cancelled by the applicant.
The rejection of claims 2-5 under 35 U.S.C. 103 is withdrawn, claims 2-5 having been cancelled by the applicant.
Pending Objections and Rejections
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 6-9 remain rejected under 35 U.S.C. 101 because the claimed invention
is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Applicant's arguments filed April 13th, 2026 have been fully considered but they are not persuasive. When identifying appropriate characteristics for markedly different characteristics analysis, appropriate characteristics can be expressed as the nature-based product’s structure, function, and/or other properties, and are evaluated on a case-by-case basis (MPEP § 2106.04(c) II. B.). The claims are drawn to a modified prescription, implying that its markedly different characteristics from naturally occurring materials is/are its biological activity or activities. The artificial weight contents of ingredients, ingredient ratios, and extraction methods do not necessarily markedly differentiate the instantly claimed composition from its naturally occurring source materials, unless these characteristics result in (a) different biological activity or activities from the natural source materials. The applicant has argued in the remarks that the instantly claimed composition has the markedly different characteristics of synergistic therapeutic effects, reduced toxicity and side effects, and improved stability. While these characteristics, compared with those of naturally occurring source materials, would markedly differentiate the instantly claimed composition from a product of nature, these arguments are not explicitly supported by disclosed working examples or by references. Furthermore, none of these markedly different characteristics are included in the subject matter claimed in claims 1 and 6-9. Appropriate characteristics must be possessed by the claimed product, because it is the claim that must define the invention to be patented. Cf. Roslin, 750 F.3d at 1338, 110 USPQ2d at 1673 (unclaimed characteristics could not contribute to eligibility) (MPEP § 2106.04(c) II. B.). Therefore, the rejection of claims 1 and 6-9 under 35 U.S.C. 101 is maintained.
Claim Rejections - 35 USC § 103
Claim 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Ru et al. (Front. Pharmacol. 2023, 13. 1078665) in view of Zhou et al. (Front. Pharmacol. 2022, 13. 974054), Zhang et al. (Food Frontiers 2022, 3. 785–795), and Huang et al. (CN-104042991-A).
The applicant has imported the limitations of cancelled dependent claim 2 into independent claim 1. Therefore, this ground of rejection relies on the prior art and arguments of record in the previous office action (a non-final rejection sent on January 13th, 2026) for the following grounds of rejection:
“Claim 1, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Ru et al. (Front. Pharmacol. 2023, 13. 1078665) in view of Zhou et al. (Front. Pharmacol. 2022, 13. 974054) and Zhang et al. (Food Frontiers 2022, 3. 785–795)”
“Claims 1, 2, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Ru et al. (Front. Pharmacol. 2023, 13. 1078665), Zhou et al. (Front. Pharmacol. 2022, 13. 974054), and Zhang et al. (Food Frontiers 2022, 3. 785–795) as applied to claims 1, 5, and 6 above, and further in view of Huang et al. (CN-104042991-A)”
The examiner’s response to the applicant’s arguments regarding these grounds of rejection are presented below.
Applicant's arguments filed April 13th, 2026 have been fully considered but they are not persuasive.
The applicant has summarized teachings of Ru, Zhou, Zhang, and Huang with respect to the biological activities of certain herbal compositions. The applicant specifically discusses the teachings of Ru in the context of the instant invention, stating “The prescription of Gancao Xiexin decoction of Ru comprises Pinelliae Rhizoma (Pinellia ternata)” and “Applicant respectfully submits that there is no teaching or suggestion provided by the existing technology to exclude the component of Pinelliae Rhizoma (Pinellia ternata) in the modified prescription of Gancao Xiexin decoction”. The applicant supports this statement by arguing that the components within a traditional Chinese medicine compound prescription are interconnected through specific interactions rather than being merely combined, and that substitution of any medicinal ingredient will inevitably alter the therapeutic efficacy, and the direction and extent of such alteration are unforeseeable to person[s] having ordinary skill in the art. The applicant summarizes their argument stating that it is non-obvious for people having ordinary skill in the art to replace Pinelliae Rhizoma (Pinellia ternata) with other medicinal materials. The applicant further states “the purpose of the present application is to provide a modified prescription of Gancao Xiexin decoction that does not contain the toxic component Pinelliae Rhizoma (Pinellia ternata) and has a better therapeutic effect for oral ulcers compared to the original prescription”. The applicant summarizes experimental results in the 37 CFR § 1.132 declaration, showing similar effects when Pinelliae Rhizoma is replaced with clam shell and Cynanchum paniculatum, and stating superior effect on treating oral ulcers when Pinelliae Rhizoma is removed compared to the original Gancao Xiexin prescription.
These arguments do overcome the rejection of instant claims 1 and 6 under 35 U.S.C 103 because these claims do not exclude Pinelliae Rhizoma (Pinellia ternate) from the instantly claimed composition. Instead, instant claim 1 uses open term “comprising” when reciting the components of the composition, and there are no further limitations upon claims 1 and/or 6 explicitly excluding Pinelliae Rhizoma (Pinellia ternata) from the composition.
The applicant has also stated that Zhou ‘947 (referring to CN-104042947-A) teaches a composition comprising Platycodonis Radix, Scrophulariae Radix, and Ophiopogonis Radix, which are not recited in instant claim 1. However, the subject matter disclosed by Zhou ‘947 was relied upon to reject cancelled claims 3 and 4, not claim 1, in the previous office action. Zhou ‘947 is no longer relied upon in this office action.
The applicant
The rejection of claims 1 and 6 under 35 U.S.C. 103 is maintained.
Claims 1 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Ru et al. (Front. Pharmacol. 2023, 13. 1078665), Zhou et al. (Front. Pharmacol. 2022, 13. 974054), and Zhang et al. (Food Frontiers 2022, 3. 785–795) as applied to claims 1 and 6 above, and further in view of Luo et al. (Drug Design, Development and Therapy 2022, 16. 1383-1405) and Ru et al. (Front. Pharmacol. 2023, 13. 1078665).
Applicant's arguments filed April 13th, 2026 have been fully considered but they are not persuasive. The applicant argues for the patentability of claims 7 and 8 through their dependence on independent claim 1, which the applicant alleges is allowable. However, the ground of rejection for independent claim 1 under 35 U.S.C. 103 is upheld for reasons argued above.
The rejection of claims 1 and 6-8 under 35 U.S.C. 103 is maintained.
Claims 1, 6, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Ru et al. (Front. Pharmacol. 2023, 13. 1078665), Zhou et al. (Front. Pharmacol. 2022, 13. 974054), and Zhang et al. (Food Frontiers 2022, 3. 785–795) as applied to claims 1 and 6 above, and further in view of Young (CA-3004879-C), and Robinson et al. (CN-101495002-A; Google Patent English Translation provided).
Applicant's arguments filed April 13th, 2026 have been fully considered but they are not persuasive. The applicant
The rejection of claims 1 and 6, 9, and 10 under 35 U.S.C. 103 is maintained.
Conclusion
No claims are 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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at (571) 272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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