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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 28 November 2025 has been entered.
Claim Status
Applicant’s remarks and amendments, filed 28 November 2025 in response to the final rejection mailed 28 July 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 28 November 2025 replaces all prior versions and listings of the claims.
Claims 1-3 and 12-21 are pending. Claims 13-21 remain withdrawn. Claims 1-3 and 12 are amended. Claims 1-3 and 12 are being examined on the merits.
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 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) treats turbid stagnation, obstruction, tightness in the chest or abdomen, feelings of nausea, vomiting, and morning sickness. Penner Cang Zhu teaches that Rhizoma atractylodis given in a dose of 3-10 g improves vision, treats night blindness and spleen failure, and reduces weight. Penner Xiang Ru teaches that Herba moslae given in a dose of 3-10 g treats stomach aches, diarrhea, bloating, and headache. Penner Ai Ye teaches that Folium artemisiae argyi given in a dose of 3-10 g treats abdominal coldness and pain, warts, goiter, and allergic reactions, and inhibits growth of cancer cells. Penner Ding Xiang teaches that 1-5 g of Flos caryophylli treats reflux Qi, unblocks the pulse, and treats parasites. Penner Bo He teaches that Herba menthae haplocalycis given in a dose of 3-6 g treats sore throats, headaches, red eyes, superficial visual obstruction, loss of voice, mouth and teeth problems, and skin ailments in the upper body.
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 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 and because modern formulations comprising excipients and methods to create stable formulations are emerging on the market (Wang et al., Introduction, page 4). 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) reduces gastric obstruction, regenerates flesh, is absorbed through skin and mucosal membranes, treat swelling, redness, and pain of the eyes, reduces growth of cancer cells, clears heat, stops pain, generates flesh and is commonly used in formulations for angina, oral ulceration, insomnia, nervousness and children’s diseases.
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 the various pharmaceutical properties of the compound, 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.
Response to Arguments
Applicant's arguments filed 28 November 2025 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to the Zhang et al. reference have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the assertion that in comparison to Control Groups 1-3, the claimed composition unexpectedly produces superior results, it is noted that the experiments on pages 44-49 are related to the unclaimed features of reducing cough, anti-asthma, and discharge of capillary sputum. 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 allowed.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655