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 .
Response to Amendment
Applicant's amendment and argument filed 04/08/2026, in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1, 3, 6-8 and 10-11 and 13-14 are pending of which claims 7-8 and 10 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/20/2025.
Claims 1, 3, 6, 11 and 13-14 are being examined on the merits.
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, 3, 6, 11, and 13-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed composition is directed to a product of nature without significantly more. The first step of the eligibility analysis evaluates whether the claim falls within a statutory category (see MPEP 2106.03). Since the claim is directed to a composition comprising plant components the claim is a composition of matter. Step 2A prong one of the analyses evaluates whether the claim is a judicial exception (see MPEP 2106.04). Because the claim states the nature-based products Ginseng Radix et Rhizoma, Ophiopogonis Radix, Schisandrae Chinensis Fructus, Poria, Pinelliae Rhizoma Praeparatum Cum Alumine, Scrophulariae Radix, bran-fried Atractylodis Rhizoma, Citri Reticulatae Pericarpium, Glycyrrhizae Radix et Rhizoma, Bupleuri Radix, Cimicifugae Rhizoma, 8- Coicis Semen, Scutellariae Radix, Verbenae Herba, Phragmitis Rhizoma, and Lophatheri Herba the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart. The claim also recites a pharmaceutically acceptable excipient wherein the pharmaceutically acceptable excipient is selected from the group consisting of a diluent, a carrier, a filler, a binder, a wetting agent, a disintegrating agent, an absorption enhancer, a surfactant, an adsorption carrier, and a lubricant, and when so broadly claimed the wetting agent and carrier or lubricant can be water.
The claim recites the naturally occurring components found within plants. Claiming plants and their particular components such as the rhizomes, radix, herba and fructus, is merely laying claim to certain biological plant structures which are their roots, fruit, leaves etc. These plants and their components are judicial exceptions even if/when being claimed together in a composition. The components that give these plants their beneficial activities are the smaller phytochemicals, flavonoids, triterpenoids, compounds, molecules, etc. found within the plant parts. These are usually extracted from the larger plant parts as extracts.
Plant extracts are made by partitioning the starting plant material into separate compositions based upon some property such as solubility in a solvent, with the soluble compounds being in one composition and the insoluble being in another composition, which compositions are then generally separated into the solvent extract of that plant versus the insoluble material composition that is generally discarded. Each composition has a different subset of the compounds originally present in the plant material. Plant extracts are purified by removing unwanted plant material from the remaining solvents. The closest naturally occurring counterparts of extracts are the same compounds found within the extract that are found in the plant in an unseparated form, even when purified, which is chemically identical to the extracted compounds. All of these are naturally occurring in nature and are not markedly different from its naturally occurring counterpart in its natural state. The properties of the nature-based product as claimed are not markedly different than the properties of these naturally occurring counterparts found in nature as these activities would inherently be found within the plants they come from. The components which would give the activities claimed in the instant invention would inherently do the same in nature as there has been nothing done in the instant invention that would make them act in any different way.
Step 2A prong two evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. This judicial exception is not integrated into a practical application because the applicant is merely claiming judicial exceptions in different amounts and this does not help to overcome the 101 rejections unless shown some synergistic activity or unexpected activity from their combination.
Doing so would be implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b).
The claims do not integrate the judicial exceptions into a practical application because in this context, such integration for a claimed product would be a physical form of the specific practical application instead of a more general composition that is not so limited.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these components and their activity are already found naturally occurring in nature and the addition of an intended use does not impart any added benefit to the compounds or integrate the composition into a practical application.
Step 2 B evaluates whether the claim as a whole, amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP § 2106.05(b)).
Since the naturally-occurring components as-claimed are not found together in nature, admixing the ingredients into a single formulation is considered an ‘additional element’ which must be analyzed for eligibility. Admixing naturally-occurring plant extracts is well-understood, routine practice in the art and has been conducted for centuries. Admixing plant extracts for creating medicinal preparations is also well-understood, routine, ordinary practice in the field as evidenced by at least the following documents: US 6200570 B1, US 6197306 B1, US 6217877 B1, US 6254899 B1 and US 6254897 B1.
Please also note, the mere modifying the concentration and proportions of the product/composition is not sufficient to remove the claimed composition from a judicial exception.
Therefore, admixing the claimed naturally-occurring ingredients at such a high degree of generality merely involves applying the natural principal and appears to be no more than a drafting effort to claim the judicial exception itself; a mixture of naturally-occurring components that is not markedly different from its’ closest-occurring natural counterpart and which does not offer significantly more than the judicial exception.
Response to Arguments
Applicant's arguments filed 04/08/2026 have been fully considered but they are not persuasive. The applicant argues that the instant composition is a medicinal preparation, not a traditional Chinese medicine composition. It is unclear what this argument pertains to or why the applicant is attempting to make this distinction as the applicant recognizes the composition is indeed a traditional Chinese medicine composition (see specifications at least at 0001). If the applicant is trying to make the distinction of a method of preparing the composition, it is pointed out the applicant elected a composition in the Election/Restriction filed on 11/20/2025. The applicant has also amended the current claims to remove language that describes how the composition is prepared. This argument is confusing. The applicant believes that since they have amended the claims to broadly recite that the composition includes an excipient selected from a carrier, a filler, a wetting agent, a lubricant, etc. that this overcomes the 101 rejection. This is not enough to overcome the rejection because those components when so broadly claimed could be another judicial exception such as water. It is suggested to claim formulations that do not exist in nature or more narrowly claim specific components in the formulation that would alter the judicial exceptions properties.
Conclusion
Currently 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 JACOB ANDREW BOECKELMAN whose telephone number is (571)272-0043. The examiner can normally be reached Monday-Friday 8am-5pm.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
Prosecution Insights