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 .
Status of the Claims
Acknowledgement is made of the response filed on October 8, 2025. In that response, claims 10 and 12- 18 were amended and claim 11 was cancelled. Claims 10 and 12-18 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 10 is objected to because of the following informalities: in line 5, “comprising” should be “comprises”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 10 and 12-18 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Claims 10 and 12-18 encompass methods of using a medicine to treat or “prevent” COVID-19 coronavirus infection. While the Applicant’s disclosure may be enabling for methods of ameliorating or treating a COVID-19 infection, it does not enable prevention or inhibition of a COVID-19 infection via administration of the medicine prepared by using the medicines recited.
In re Wands, 858 F.2d 731, 736-40, 8 USPQ2d 1400, 1403-07 (Fed. Cir. 1988), set forth eight factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." (MPEP § 2164.01)
a. The breadth of the claim: The rejected claims are drawn to methods of preventing or inhibiting prevention or inhibition of a COVID-19 infection via administration of the medicine prepared by using the medicines recited. Claim term "prevent" implies that the infection is completely absent in patients treated according to the methods claimed.
b. Nature of the invention: The nature of the invention is methods of preventing or i a COVID-19 infection in patients by “using” the medicine prepared by “using” the recited traditional medicine materials. Claim 10 encompasses any method of administration or usage, or any form of a medicine prepared using the nine medicine materials.
c. The state of the prior art: Xiao (CN 109364206 A, of record) teaches cough-relieving granules made from a combination of the nine materials in instant claim 10, each in identical proportion ranges in claim 10, and the proportions in claims 13-15 (title; abstract; p.6 middle; claims 1, 2). Xiao further teaches the methods in claims 17 and 18 (abstract lines 1-7; p.3 “step 1” - p.4 second middle). The dosage forms include those in claims 15 and 16 (p.5 middle). Prevention or inhibition of a COVID-19 infection or any coronavirus infection causing a cough, however, was not attained or reported in Xiao.
d. Level of one of ordinary skill in the art: the level of ordinary skill is high as trained physicians would practice prevention of a COVID-19 infection by using a combination of nine medicinal materials.
e. Level of predictability in the art: the level of predictability in infection prevention is low due to wide variability among individuals in factors that affect a person’s susceptibility to a COVID-19 infection, such as individual immune response, the extent of exposure, and evolving virus variants, among others.
f. Amount of direction provided by the inventor: Applicant does not appear to disclose guidance or methods of how to specifically prevent or inhibit a COVID-19 infection by using a medicine prepared by using the recited traditional medicine materials.
g. Existence of working examples: The disclosure includes one in vitro study conducted on a single specific medicine composition, with Vero cells and 2019-nCoV 100TCID50. Dilution at 1:1, 1:10, 1:1000, and 1:1000 inhibited viral cytopathic effect (CPE). There is no other study. Notably the single specific medicine composition tested included specific relative quantities of each medicine in claim 10, which combination was extracted using 70% ethanol and water in a specific extraction protocol involving repeated decoctions, concentration, drying, mixing, and processing into granules (see Specification paras.[0022-23]). No other example is disclosed regarding the actual ability of the granules in preventing a COVID-19 infection, or treating any symptoms of a COVID-19 infection.
h. Quantity or experimentation needed to make or use the invention based on the content of the disclosure: considering the state of the art as discussed by the references above, particularly regarding the unpredictability of preventing a COVID-19 infection, wide variability among individuals, and the lack of guidance provided in the specification, the person of ordinary skill would have to engage in significant amount experimentation and ingenuity to practice the invention commensurate in the scope of the claims.
In conclusion, the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with claims 10 and 12-18.
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.
Claim(s) 10 and 12-18 are rejected under 35 U.S.C. 103 as being unpatentable over Xiao (CN 109364206 A published on 2/22/2019; listed on IDS; see attached machine translation) in view of Williams (Williams, V., COVID-19: Information on symptoms, transmission, Mayo Clinic, March 3, 2020, available at https://newsnetwork.mayoclinic.org/discussion/covid-19-information-on-symptoms-transmission/, accessed on October 30, 2025).
Xiao teaches a cough-relieving granule preparation made from a combination of the nine materials in instant claim 10, each in identical proportion ranges in claim 10, and the proportions in claims 12-14 (title; abstract; p.6 middle; claims 1, 2). Xiao further teaches the processing methods in claims 17 and 18 (abstract lines 1-7; p.3 “step 1” - p.4 middle). The dosage forms include those in claims 15 and 16 (p.5 middle).
Xiao does not specifically teach treating a COVID-19 infection using its granules or the combination of the nine medicinal materials it teaches as recited in claim 10.
Williams was published in March 2020, early in the Covid-19 pandemic. Williams reports a doctor interview, stating the “corona viruses typically cause respiratory illnesses” (p.2 first full para.), and the “main symptoms that have been described with COVID-19 are fever, cough and shortness of breath," (p.2 under “COVID-10 symptoms” (emphasis added)).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Xiao and Williams and use Xiao’s preparation to treat a COVID-19 infection as recited in the instant claims. The skilled person would have been motivated to do so in order to treat a patient of a COVID-19 infection who suffers from coughing.
Response to Arguments
Applicant’s arguments with respect to claim(s) 10 and 12-18 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.
CONCLUSION
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 H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614
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