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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. 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 on November 17, 2023. The priority date is May 20, 2021.
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 11/20/2025 is acknowledged. The traversal is on the ground(s) that the applicant has amended the claims to recite specific amounts and argues that these amounts or the specific selection of each 15 ingredients would not have been obvious or anticipated. This is not found persuasive because the election/restriction is based on the special technical feature being previously disclosed in the art. The special technical feature has not changed and as previously written in the election/restriction filed on 09/22/2025, has been disclosed thus breaking unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7-8 and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 09/22/2025.
Claims 1, 3, 5-6 and 11-14 are being examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 17, 2023 is being considered by the examiner. The signed IDS form is attached with the instant office action.
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.
Claims 5 and 14 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.
In claim 5, it is unclear how the adjuvant has a different function than art recognized. The term “adjuvant” is understood in the art to be a substance that boost effectiveness of a vaccine or an additional therapy in cancer therapy after primary therapy to treat cancer from returning.
Regarding claim 14, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Suggest removing the phrases, “for example 2, 3, 4, 5, 6, 7, 8, 9 or 10, and “for example, 30, 40, 50, 60, 70, 80, or 90 minutes,” from the claim.
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, 5-6 and 11-14 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 adjuvant and when so broadly claimed could be polysaccharides, saponins, chitosan etc. which are all nature components and would be judicial exceptions that would receive the same analyses.
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.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang Faping (CN1300623A) and Xu Wangang (CN1034859A).
Faping teaches creating a traditional Chinese composition by including more than 1900 Chinese-medicinal materials for creating a pill for the treatment of HIV (AIDS), syphilis and hepatitis B, of which the instantly claimed components are included except for Coicis Semen (see claim 1).
Faping does not teach the composition to comprise of Coicis Semen and adjuvant and does not teach the particular amounts of each active ingredient as claimed.
Xu Wangang, document (CN1034859A) teaches a preparation to enhance immunity for HIV infections (see abstract) and teaches wherein Coicis Semen is used in the formulation for the effect that promotes cellular immunization, humoral immunization (see page 9, middle of page section 2).
Wangang teaches wherein the composition can be made from extracts and into granules for creating feedstuff formulations and utilizations (see page 3, 4-5 para.).
Wangang also teaches that Lentinus Edodes has immunization: lentinan can significantly increase from the thymus humoral response tumor-bearing mice, can recover the antigenic ability of mice opposing hapten-carrier” (see page 8, 2.) and this could act as the pharmaceutically acceptable adjuvant as it is described as increasing the thymus humoral response.
Therefore it would have been prima facie obvious before the effective filing date to persons having ordinary skill in the art to include Coicis Semen in the composition for treating HIV as taught by Faping because as Wangang teaches it can assist with humoral and cellular immunity and is an ingredient known for treating HIV. It would have been obvious to persons having skill in the art to optimize the plant components to be within the instantly claimed ranges because many times skilled artisans will serial dilute in order to test at varying ranges for effective activities. A serial dilution is the step-wise dilution of a substance in solution, either by using a constant dilution factor, or by using a variable factor between dilutions and this allows for a geometric progression of the tested concentrations in logarithmic fashion. Also, adjusting the plant parts out of solution to be within a range of 1 to 10 parts is also well within the purview of any skilled artisan. As discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” The references teach the use of each of the ingredients in a pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang Faping (CN1300623A) and Xu Wangang (CN1034859A) as applied to claims 1, 3 and 5-6 above, and further in view of Shubhajit Paul et. al. (Tableting performance of various mannitol and lactose grades assessed by compaction simulation and chemometrical analysis, International Journal of Pharmaceutics 566 (2019) 24–31).
Faping and Wangang’s combined teachings make obvious the instant invention however the combined art does not teach using mannitol and lactose in the composition.
Wangang also teaches the use of water and boiling three to five times (decocting) herbs (see page 10).
Paul teaches that “mannitol and lactose are commonly used fillers in pharmaceutical tablets, available in several commercial grades that are produced using different manufacturing processes” (see abstract).
Therefore it would have been prima facie obvious to include mannitol and lactose in creating a tablet for the herbal composition taught by Faping and Wangang because Paul teaches that these components are commonly used as fillers in creating pharmaceutical tablets. Wangang teaches the use of decocting herbs with water and so doing so with the remaining herbs would have been an obvious component to arrive at concentrated herbal extracts which can then be freeze-dried to prolong the stability of the active components and used to create tablets with the filler’s mannitol and lactose. The examination is to a medicine preparation and not to the process of making that preparation per se. Although the art does not teach the relative density of the concentrated components this does not appear to distinguish the medicinal tablets in any way over the prior art. The prior art teaches medicinal pills and tablets that comprise of the same ingredients. Optimizing those amounts is prima facie obvious especially given that the applicant has not shown the ranges as critical. Although the prior art teaches many other ingredients to include in the formulations the applicant allows for additional ingredients because they simply state a composition containing specific ingredients and it is interpreted as allowing additional components. It is suggested to use proper claim language “comprising”, “comprising essentially of, “consisting” or “consisting essentially of” to better describe their intended formulation.
It would have been obvious to persons having skill in the art to optimize the plant components to be within the instantly claimed ranges because many times skilled artisans will serial dilute in order to test at varying ranges for effective activities. A serial dilution is the step-wise dilution of a substance in solution, either by using a constant dilution factor, or by using a variable factor between dilutions and this allows for a geometric progression of the tested concentrations in logarithmic fashion. Also, adjusting the plant parts out of solution to be within a range of 1 to 10 parts is also well within the purview of any skilled artisan. As discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” The references teach the use of each of the ingredients in a pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
Conclusion
Currently no claims are allowed.
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.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655