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 .
Claim Status
Applicant’s remarks and amendments, filed 24 August 2026 in response to the non-final rejection mailed 24 March 2026, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 24 August 2026 replaces all prior versions and listings of the claims.
Claims 1-3 and 12-18 are pending. Claims 13-18 remain withdrawn. Claim 1 is amended. Claims 1-3 and 12 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Claim Rejections - 35 USC § 112(b)
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 1-3 and 12 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 1, as written, the phrase “for reducing cough, anti-asthma, discharge of capillary sputum, and/or treatment of rhinitis” is unclear because it is not clear what “reducing anti-asthma” means in the context of the instant specification. Alternatively, it is unclear what is meant by “anti-asthma” and “discharge of capillary sputum” without a qualifying phrase such as reducing, treating, preventing, ameliorating, or the like commensurate in scope with the instant disclosure. Appropriate clarification is necessary.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under 35 U.S.C. § 112(b) for the reasons set forth above.
Claim Rejections - 35 USC § 103
(grounds modified as necessitated by amendment)
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 1, 3, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Penner Huo Xiang (American Dragon, 2017, 3 pages); Penner Cang Zhu (American Dragon, 2017, 3 pages); Penner Xiang Ru (American Dragon, 2017, 3 pages); Penner Ai Ye (American Dragon, 2017, 3 pages); Penner Ding Xiang (American Dragon, 2017, 2 pages); Penner Bo He (American Dragon, 2017, 3 pages); and Wang et al. (Plant Extracts, 2019, 32 pages).
The instant claims are as of record, drawn to a pharmaceutical composition comprising a volatile oil or aromatic water which is made of raw materials consisting of 4-14 parts of Herba Pogostemonis, 9-28 parts of Rhizoma Atractylodis, 5-18 parts of Herba Moslae, 11-33 parts of Folium Artemisiae Argyi, 0.1-3 parts of Flos Caryophylli, and 2-10 parts of Herba Menthae Haplocalycis.
Penner Huo Xiang teaches that Herba pogostemonis given in a dose of 3-10 g (e.g., 3-10 parts when 1 part = 1 gram) expels externally contracted pathogenic cold (broadly, rhinitis). Penner Cang Zhu teaches that Rhizoma atractylodis given in a dose of 3-10 g drives out phlegm (broadly, capillary sputum) and induces sweating and expels wind-dampness with nasal congestion (broadly, rhinitis). Penner Xiang Ru teaches that Herba moslae given in a dose of 3-10 g helps throw off the pathogenic Cold (broadly, rhinitis). Penner Ai Ye teaches that Folium artemisiae argyi given in a dose of 3-10 g treats allergic reactions (broadly, rhinitis). Penner Ding Xiang teaches that 1-5 g of Flos caryophylli treats reflux Qi, unblocks the pulse, and invigorates the blood. Penner Bo He teaches that Herba menthae haplocalycis given in a dose of 3-6 g treats sore throats and colds (broadly, rhinitis).
Penner does not teach wherein the herbs are used to make a volatile oil or aromatic water.
Wang et al. teach that herbal materials used in traditional Chinese medicine are often extracted with water to make an aqueous extract or decoction (volatile oil; aromatic water; Wang et al., Introduction, page 2; as required for instant Claim 1). These decoctions can be combined with excipients (pharmaceutical excipient; Wang et al., page 4, 19; as required for instant Claim 3) and prepared as granules for administration to patients. Additional dosage forms include oral liquids (e.g., sprays, aerosols, drops), tablets, capsules (soft capsule), and injections (Wang et al., 2.7.1., page 19; as required for instant Claim 12).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the various ingredients taught by Penner with the methods of formulation taught by Wang et al. to arrive at the instantly claimed invention. A skilled artisan would be motivated to combine the ingredients with various pharmaceutical effects, which include those relating to treating pathogenic cold, inflammation, allergic reactions, sore throat, and driving out phlegm to create a pharmaceutical composition because multicomponent therapeutic formulae are the most important and most commonly used in traditional Chinese medicine (Wang et al., Introduction, page 2). Additionally, a skilled artisan could combine the teachings with a reasonable expectation of success because the various ingredients have varied pharmaceutical effects related to reducing swelling (e.g., rhinits) and driving out phlegm (e.g., capillary sputum) and because modern formulations comprising excipients and methods to create stable formulations are emerging on the market (Wang et al., Introduction, page 4). A skilled artisan would additionally be motivated to include Flos Caryophylli because of its additional effects of unblocking the pulse and invigorating the blood, and could therefore incorporate it into a pharmaceutical composition with a reasonable expectation of success. Additionally, if not expressly taught by Penner, based upon the overall beneficial teaching provided by this reference with respect to the effect of the various herbs in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable amount of Folium artemisiae argyi), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Claims 1-3 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Penner Huo Xiang (American Dragon, 2017, 3 pages); Penner Cang Zhu (American Dragon, 2017, 3 pages); Penner Xiang Ru (American Dragon, 2017, 3 pages); Penner Ai Ye (American Dragon, 2017, 3 pages); Penner Ding Xiang (American Dragon, 2017, 2 pages); Penner Bo He (American Dragon, 2017, 3 pages); and Wang et al. (Plant Extracts, 2019, 32 pages) as applied to Claims 1, 3, and 12 above, and further in view of Penner Bing Pian (American Dragon, 2017, 3 pages).
The claims and teachings of Penner and Wang et al. are as of record.
Penner Huo Xiang; Penner Cang Zhu; Penner Xiang Ru; Penner Ai Ye; Penner Ding Xiang; Penner Bo He; and Wang et al. do not teach wherein the composition further comprises 0.01-0.2 parts natural borneol.
Penner Bing Pian teaches that Borneolum (natural borneol) in a dose of 0.01-0.9 g (e.g., if 1 g = 1 parts this is equivalent to 0.01-0.9 parts by weight; as required for instant Claim 2) dispels pathogenic factors in the chest (broadly, phlegm) and reduces swelling (broadly, rhinitis).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to combine the various ingredients taught by Penner with the methods of formulation taught by Wang et al. to arrive at the instantly claimed invention. The addition of Borneolum to the decoction of the other herbs taught by Penner would have been obvious to a skilled artisan due to its effects of reducing pathogenic factors in the chest and reducing swelling, and it also would have been obvious to add it to the decoction rather than as part of the decocted herbs because it is not usually decocted due to its volatile nature (Penner Bing Pian, page 3). Its addition could also help with absorption of the various dosage forms taught by Wang et al. through the skin and mucosal membranes. A skilled artisan could therefore incorporate Borneolum into the pharmaceutical composition with a reasonable expectation of success.
With respect to the USC 103 rejections above, please note that the intended use of the claimed composition (for reducing cough, anti-asthma, discharge of capillary sputum, and/or treatment of rhinitis) does not patentably distinguish the composition, per se, since such undisclosed use is intrinsic to the composition reasonably suggested by the cited references, as a whole. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting (see, e.g., MPEP 2112).
From the teachings of the references, 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 made, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685,
688 (CCPA 1972).
Response to Arguments
Applicant's arguments filed 24 August 2026 have been fully considered but they are not persuasive.
Applicant argues that a skilled artisan would not be motivated to combine various individual herbal components because they are taught individually and that the specific “consisting” formulation and therapeutic efficacy are not reasonably disclosed or suggested.
Firstly, it is noted that the amount of Folium Artemisiae Argyi taught by the prior art, while not overlapping that of the instant invention, is a close value which a skilled artisan could reasonably arrive at via routine optimization, particularly without evidence to the contrary. 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 (see MPEP § 2144.05). Additionally, there is no evidence that the parts by weight used for making the volatile order or aromatic water are critical to the composition, particularly since they are diluted an unknown amount when added into the broad comprising composition of the instant claims.
Regarding therapeutic efficacy, it is noted that the intended use of the claimed composition (for reducing cough, anti-asthma, discharge of capillary sputum, and/or treatment of rhinitis) does not patentably distinguish the composition, per se, since such undisclosed use is intrinsic to the composition reasonably suggested by the cited references, as a whole. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting (see, e.g., MPEP 2112). Each individual component has varying effects in traditional Chinese medicine as disclosed above which relate to treating pathogenic cold, inflammation (e.g., suppression of inflammatory responses, as indicated in the response filed 24 August 2026 on pg. 8), allergic reactions, sore throat, and driving out phlegm, and additionally the effect of Flos caryophylli of unblocking the pulse, and thus a skilled artisan would be motivated to combine these ingredients in order to arrive at the instantly claimed invention. It is additionally noted that, as written, it is not required that administration of the composition in therapeutic amounts to a particular patient population results in a specific effect (e.g., reduction of HIS, IL-4, and TNF alpha levels; reducing cough; anti-asthma effects; reducing discharge of capillary sputum; treating rhinitis) has a specific effect relative to an untreated control group, each individual ingredient, or another known treatment. The claims merely indicate that the composition is broad comprising composition which has a specific intended use; it does not require that the volatile oil/aromatic water is an active ingredient with a specific effect at a specific dose. Additionally, as a “comprising” composition, it does not exclude the addition of actives which are commonly used for treating asthma, cough, or rhinitis such as oral corticosteroids, antitussives, or expectorants.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., reduction of serum HIS, IL-4, and TNF alpha levels) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
No claims are currently 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 JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 5:00am to 5:00pm EST.
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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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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
