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 06/28/2024.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/28/2024 is being considered by the examiner. The signed IDS form is attached with the instant office action.
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 06/03/2026 is acknowledged. The traversal is on the ground(s) that the applicant believes with the new amendments that there is now a special technical feature and thus creating unity of invention. This is not found persuasive because the applicant is still claiming distinct inventions which would require different search and consideration and it cannot be predicted how the applicant will amend the claims during prosecution; therefore the inventions are separate and distinct. Additionally, unity of invention will be shown to be broken through the combined prior art utilized in the 35 U.S.C. 103 rejection below.
The requirement is still deemed proper and is therefore made FINAL.
Claims 20-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 06/03/2026.
Claims 17-19 are being examined on the merits.
Drawings
The drawings are objected to because the pages are not numbered which would be in compliance with MPEP guidelines. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 17-19 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. Claim 17 recites “A Chinese herbal medicine extract, comprising an active ingredient that contains agarwood, Chinese honey locust fruit, Chinese honey locust spine, cinnamon leaf, and camphor leaf”. It is unclear how an active ingredient can contain all of these herbal components. The examination is to a composition and not necessarily to a method of making the composition or ingredients, therefore how does one come up with an ingredient that contains all of these herbs? The claim language is indefinite.
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
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 17-19 are rejected under 35 U.S.C. 101 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 agarwood, Chinese honey locust fruit and spine, cinnamon leaf and camphor leaf 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. This judicial exception is not integrated into a practical application because the applicant is only claiming the nature-based components and within a certain ratio which does not incorporate them into any 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 antiviral application is also well-understood, routine, ordinary practice in the field as evidenced by at least the following documents: US20190209634A1, US20190209634A1, US20110177180A1, US7648717B2 and US20090053335A1.
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 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.
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Amalia Tri Utami (A case study: The benefit essential oil of bukhoor (Aquilaria Malaccensis) to decrease respiratory distress in COVID-19 era, Abstract: Mycobacterial Diseases, 3rd International Conference on Enzymology and Molecular Biology, Volume 10, Issue 3, Jul 24, 2020), Singh RS et. al. (From IDS, Promising Traditional Indian Medicinal Plants for the Management of Novel Coronavirus Disease: A Systematic Review, Phytotherapy Research, vol. 35, no. 8, 99. 4456-4484, 30 August 2021), Shahrajabian et. al. (Study of Chinese honey locust (Gledistsia sinensis) and shallot (Allium Ascaloncium L.) for integrate traditional Chinese Medicine into other countries’ medicine in order to improve public health, Проблеми Охорони Праці в Україні 36(2)/2020), and Maryam Yakhchali et. al. (Cinnamon and its possible impact on COVID-19: The viewpoint of traditional and conventional medicine, Biomedicine & Pharmacotherapy 143 September 16, 2021).
Utami teaches “Coronavirus or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a virus that attacks the respiratory system. The disease due to this viral infection is called COVID-19. Coronavirus can cause mild disorders of the respiratory system, severe lung infections, and death. Imam Bukhari wrote that Bukhoor is known to be an excellent aroma to strengthen the body and mind. The Prophet (SAW) said: "Indulge in raw Arabian incense (Oud Al-Arab) to have the cure for seven ailments; by smelling the fragrance if someone has throat problems and by putting it in the mouth (smoked like a candy pen) when suffering from pleurisy." (see Introduction, first page).
Utami teaches “the woman, 29 years old with respiratory distress, confirm positive with a rapid test, using a Bakhoor humidifier in a week for 30 minutes daily. We find an improvement of peak expiratory flow rate from the red zone to the green area after treatment.
Aquilaria Malaccensis or Bakhoor as the therapeutic properties of aromatic medicines affecting the flow of the vital force in the lungs, chest, and heart” (see Results and Conclusion, last page).
Utami does not teach the composition to comprise Chinese honeylocust fruit, Chinese honeylocust spine, cinnamon leaf, and camphor leaf.
Singh teaches that camphor (a Cinnamomum camphora leaf extract) can be used for the treatment of SARS-COV-2 (see page 4456, abstract).
Shahrajabian teaches to strengthen immunity and improve the health of workers, traditional Chinese medicine, which has achieved great success at present, can be recommended. Gleditsia sinensis Lam. (G. sinensis) is a perennial arbour spread in most parts of the world, especially in China. It is a classical traditional Chinese medical herb. The most important components of Gleditsia sinensis are triterpenoid saponins, triterpenes, flavonoids, alkaloids, phenolics, sterols, and their important derivatives are responsible for tremendous medicinal effects. It has been reported that Gleditsia sinensis Lam thorn (GST) possesses a wide spectrum of pharmacological activities such as antioxidant, anti-inflammatory, anti-microbial, anti-angiogenic and anti-tumor effects. Its fruit is antibacterial, antifungal, antitussive, astringent, emetic, expectorant, haemostatic and stimulant. (see abstract).
Gledistsia sinensis possesses antiallergic and anti-inflammatory activities, which may be mediated by decreasing the release of mediators like histamine from mast cells and also weakening the inflammatory action of all these mediators (see page 9, right column).
“Choi et al. [30] suggested that fruit hull of Gleditsia sinensis(FGS) effectively vanquish neutrophilic lung inflammation, which can be associated with, at least in part, FGS-activating anti-inflammatory factor of Nrf2”
“Kim et al. [31] indicated that the fruit hull of Gleditsia sinensis(FGS) could enhance the antitumor activity of cis-diammine injury (ALI)” (see page 10, left column at top).
Yakhchali teaches that “Traditional Persian Medicine (TPM), due to its holistic view, can provide recommendations for the prevention and treatment of new diseases such as COVID-19. The muco-obstruction of the airway, which occurs in SARS-CoV-2, has similar features in TPM textbooks that can lead us to new treatment approaches. Based on TPM and pharmacological studies, Cinnamomum verum (Darchini)’s potential effective functions can contribute to SARS-CoV-2 infection treatment and has been known to be effective in corona disease in public beliefs. From the viewpoint of TPM theories, Cinnamon can be effective in SARS-CoV-2 improvement and treatment through its anti-obstructive, diuretic, tonic and antidote effects. In addition, there is pharmacological evidence on anti-viral, anti-inflammatory, antioxidant, organ-o-protective and anti-depression effects of Cinnamon that are in line with the therapeutic functions mentioned in TPM. Overall, Cinnamon and its ingredients can be recommended for SARS-CoV2 management due to multi-targeting therapies” (see abstract).
“Cinnamon has a high penetration property into the chest, so it attenuates the material inside the chest, especially thick phlegm, cuts and clears it from the place it is attached to. In this way, it prepares the material for exit and opens the lung ducts [15,32]. Therefore, it cleans and warms the chest and lungs, facilitates the breath, opening its ducts, beneficial to asthma, shortness of breath, and cough, especially chronic cold ones. It is also helpful in fever and chills [15,32,33]. It can be said that due to cutting the thick and viscose phlegm, Darchini has mucolytic activity on pulmonary mucosa. Mucolytic drugs reduce mucin viscosity by cutting disulfide bonds of gel mucins [37].
“Since Cinnamon is a strong opener, it can also be a great diuretic. It heats the kidneys and softens the thick materials in them. It cleans the kidneys and relieves their pain [15]. Cinnamon can also open the obstruction of the liver, spleen, and gallbladder due to its great thin nature, enabling it to penetrate these organs. From TPM’s point of view, Cinnamon warms the stomach and liver, strengthens them for digestion, dries up the extra moisture from the stomach, attenuates and cuts phlegm, cleans it from waste materials, and digests thick foods [15,33, 34]. Along with paying attention to respiratory and other complications in patients with pneumonia and respiratory failure in ICU, improving the gastrointestinal tract function is of great importance and useful in treatment [38]. Darchini prevents humor from infection and modifies infectious humor by drying excess moisture. In addition, it is a tonic drug for almost all organs, including the heart, liver, and stomach. It prevents pathogens entry into organs by its astringent effect and moderating organs’ properties, making them less prone to damage. Due to its strong aroma, Cinnamon is an exhilarating drug and causes happiness in the heart [15,32,33]. Iranian traditional medicine researchers have suggested that “Moghavvi” or tonic drugs mentioned in TPM can effectively manage the disease and protect main organs from SARS-CoV-2 damage” (see page 3, bottom left and top right columns).
“Cinnamon ingredients similar to curcumin can be effective on various proteins contributing to the virus proliferation process [44]. A molecular docking analysis on key protein targets of SARS-CoV-2 predicts interaction of C. zeylanicum essential oil components (eugenol, linalool, (E) cinnamaldehyde, (E) cinnamyl acetate, β-caryophyllene, eugenyl acetate, benzyl benzoate) with the virus targets in the body. Although the interactions were relatively weak, they may have synergistic effects inhibiting the coronavirus [45]. In silico analysis of 48 phytochemicals from different Cinnamon species showed that Tenuifolin and Pavetannin C1 had a higher binding affinity to the SARS-Cov-2 main protease enzyme and spike protein [46]. Ranjini et al. determined Angiotensin-converting enzyme inhibition by C. zeylanicum methanolic extract in sheep kidney, lung, and testis. Reducing ACE activity was almost near the standard drug (captopril) in the kidney [47]. Phenolic compounds, caffeic acid, cinnamic acid, gallic acid, and eugenol extracted from Cinnamomum zeylanicum exhibited an inhibitory effect of trypsin (a serine protease). Caffeic acid (IC50 =84%) and cinnamic acid (IC50 =53%) had the most enzyme inhibition potential [48]. Angiotensin-converting enzyme (ACE2) and type 2 trans membrane serine protease (TMPRSS2) are expressed in target cells participant in SARS-CoV-2 infection [49]. These findings (Fig. 2) may lead us to suggest Cinnamon as an anti-viral medicine for treating SARS-CoV-2 and similar diseases along with other drugs” (see 3.1, Anti-viral effects, page 3).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to combine each ingredient into a single composition in creating a Chinese herbal medicine extract comprising of each herbal component. Utami teaches that agarwood (Bakhoor) has the therapeutic properties of aromatic medicines affecting the flow of the vital force in the lungs, chest, and heart. Singh teaches that camphor (a Cinnamomum camphora leaf extract) can be used for the treatment of SARS-COV-2. Shahrajabian teaches that Gleditsia sinensis Lam thorn (GST) possesses a wide spectrum of pharmacological activities such as antioxidant, anti-inflammatory, anti-microbial. Its fruit is antibacterial, antifungal, antitussive, astringent, emetic, expectorant, haemostatic and stimulant. Yakhchali teaches that Cinnamon ingredients can contribute to SARS-CoV-2 infection treatment and has been known to be effective in corona disease. Cinnamon can be effective in SARS-CoV-2 improvement and treatment through its anti-obstructive, diuretic, tonic and antidote effects. In addition, there is pharmacological evidence on anti-viral, anti-inflammatory, antioxidant, organ-o-protective and anti-depression effects of Cinnamon that are in line with the therapeutic functions mentioned. Thus combining extracts of each ingredient from its specific floral component would have been prima facie obvious for increasing the symptom treatment of SARS-COV-2 and for the beneficial effects which can be contributed from each individual ingredient/extract.
It would have also been obvious to optimize each component in the weight ratio of equal components as this is well within the purview of any skilled artisan. Thus, it is known to combine 5 components together for the same purpose. The adjustment of particular conventional working conditions (i.e. determining the suitable amounts of the active ingredients) is deemed merely a matter of judicious selection and routine optimization, which is well within the purview of the skilled artisan.
The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known for treating SARS-COV-2 in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Therefore, there is a reasonable expectation of success, based upon prior references and what is known in the art, that the modified teachings of Utami, Singh, Shahrajabian and Yakhchali along with any optimization needed, would meet the claimed limitation of the instant 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
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