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
Newly amended claims 2-19 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The applicant has amended claims 2-19 being directed to a method of treatment and the original examination was to a composition. Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 2-19 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim 1 is 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 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite a pharmaceutical composition containing herbal extracts of two or more selected from the group consisting of Genkwae Flos, Clematidis Radix, and Gastrodiae Rhizoma. 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 Genkwae Flos, Clematidis Radix, and Gastrodiae Rhizoma the markedly different characteristics is performed by comparing the nature-based product limitation to its natural counterpart.
The claim recites the naturally occurring components found within plants. 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. These judicial exceptions are not integrated into a practical application because the claims are only directed to the judicial exceptions themselves and claiming them in different ratios/amounts, or limiting how they are extracted, or claiming them with a specific intent or activity (for preventing or treating specific neurodegenerative diseases) does not incorporate those judicial exceptions into any specific practical application.
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 treating neurodegenerative diseases is also well-understood, routine, ordinary practice in the field as evidenced by at least the following documents: (US5629307A), 05-13-1997, (US20020013339A1), 01-31-2002, (US20020049251), 04-25-2002, (US20030211178A1), 22-13-2003, and (US20010001896A1), 01-01-2004.
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 01/09/2026 have been fully considered but they are not persuasive. The applicant argues that the claimed aqueous ethanol extract of Clematidis Radix and Gastrodiae Rhizoma in a weight ratio of 1:1 or an aqueous ethanol herbal extract of Genkwae Flos, Clematidis Radix and Gastordiae Rhizoma in a weight ratio of 1:10:10 creates a composition not found in nature. It is not the composition per se but the components of the composition that are the judicial exceptions which are the claimed plant components, even when combined together and claimed as a composition. The applicant argues that the extraction process concentrates active compounds beyond their natural levels creating markedly different characteristics. The mere concentration of natural compounds does not overcome the rejection as the applicant would still be laying claim to those natural judicial exceptions, just at higher amounts and concentrations.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 is rejected under 35 U.S.C. 103 as being unpatentable over Kug et al. (KR2011-0138531A) and Je et. al. (KR2016-0058992A). This is a new rejection based on the amendments filed on 01/09/2026.
Kug’s general disclosure is to compositions for preventing and treating neurodegenerative diseases containing extracts of Gastroida elata (see abstract).
Regarding claim 1, Kug teaches “a pharmaceutical composition containing Gastrodia elata extract is provided to ensure resistance to neural cell apoptosis and to prevent and treat brain diseases. A pharmaceutical composition for preventing and treating brain diseases contains Gastrodia elata extract as an active ingredient. The extract is isolated using water, low alcohol of C1-C4, or mixture solvent thereof (see abstract).
Kug teaches the specific neurodegenerative diseases to be Parkinson’s and Alzheimer’s disease (see page 2, top). Kug teaches the extract was confirmed to inhibit the cytotoxicity and ROS generation, and effectively inhibit the expression of genes and proteins associated with neuronal cell death (see page 2, para. 5, Fig 3).
Kug does not teach the composition to comprise of either Genkwae Flos, Clematidis Radix.
Je’s general disclosure relates to a composition for preventing or treating dementia or improving cognitive ability comprising an 80% methanol extract of Clematis mandshurica as an active component (see abstract).
Je teaches a food composition for preventing or alleviating dementia, which comprises methanol extract of Clematis mandshurica as an active ingredient (see page 2, para. 7).
Je teaches the extract activates acetylcholinesterase inhibition and inhibits brain-derived neurotrophic factor (BDNF) and cAMP-response-element -binding protein, CREB) (see page 6, para. 5).
Je does not specifically teach that the extract is aqueous ethanol, however methanol and ethanol have very similar polarities and many times extract out similar compounds due to those polarities being overlapping. Therefore it would have been obvious to persons skilled in the art to combine an aqueous ethanol extracts of Clematis mandshurica radix and Gastrodia elata rhizome extract as an active component in a composition for treating neurodegenerative diseases because Je teaches this extract can prevent and treat dementia and improve cognitive function and Kug teaches that aqueous ethanolic extracts from Gastorida elata are specific for treating neurodegenerative diseases such as Parkinson’s and Alzheimer’s. Selecting ethanol as a solvent is well within the purview of any skilled artisan given the relied upon art. It would have further been obvious to optimize each component in a 1:1 ratio as this also is well within the purview of any skilled artisan given the relied upon art and indeed would be an obvious starting point in combining the active ingredients.
Given the prior art there would have been a reasonable expectation of success in arriving at the instant invention because the extracts are each known for the same purpose of preventing and treating a neurodegenerative disease.
If not expressly taught thereby, based upon the overall beneficial teaching provided by the reference(s) with respect to extracting and the conditions disclosed in the manner disclosed therein, and further considering the knowledge and ordinary skill of one in the art (of neurodegenerative diseases and of herbal extractions, for example), the adjustments of particular conventional working conditions (e.g., determining one or more suitable component material or extraction solvent, and amounts (including concentrations, proportions, and ranges) in which to provide such a composition, as instantly claimed), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 01/09/2026 have been fully considered but they are not persuasive. The applicant argues that none of the pieces of art teach the synergistic effect from the combination in treating a degenerative disease as demonstrated in the present application. The only test that the applicant administers which would ultimately be able to show if the herbal composition(s) claimed has synergy is the latency to fall Rotarod test (see figure 1). However the activity from the combined ingredients appears to be additive. It is not until there is an increase in concentration of 10mg/kg of the combined three herbal formulation that we see what may possibly be what is more than an additive effect but there is no comparison of the individual ingredients at that concentration of 10mg/kg. The applicant only tests the individual ingredients at 1mg/kg and 3mg/kg and compares them to the combined herbal composition.
Therefore the does not appear to be noted synergy from the combination of ingredients. Also the applicants claim is directed to more than the combination of those three ingredients as there is a combination of two ingredients which there also does not show any synergy.
The applicant argues that a person having ordinary skill would not be motivated to combine the herbs and have an expectation of synergy. A POSITA would combine the herbs together for an expectation of the plants’ components combined activities as discussed above. For instance a POSITA would combine ethanolic extracts from Gastorida elata for preventing preventing and treating brain diseases such as Parkinson’s disease and Alzheimer’s disease specifically for effectively inhibiting the expression of genes and proteins associated with neuronal cell death with that of Clematis mandshurica for preventing or treating dementia or improving cognitive ability. The applicant argues that there is synergy noted with a behavioral ability test wherein there is some increase of 19%, 44.8% and 75% from the administration of 1, 3 and 10mg/kg, however the activity from the combined ingredients appears to be additive because when you add each effect from each herbal component this seems to equal the amount to the three herbal component mixtures.
It appears that the combination of ingredients is additive and not synergistic however additional data may need to be supplied on the numbers in latency units from each individual herbal test instead of just being represented in a bar graph. Additionally, the applicant’s claim 1, recites a composition comprising an aqueous ethanol herbal extract of Clematidis Radix and Gastrodiae Rhizoma in a weight ratio of 1:1 which is not the comparison being argued for the synergy. It would be suggested to supply any additional data that could help show evidence of the argued synergy because from the figure provided it does appear to be merely additive.
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.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655