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 .
DETAILED ACTION
Claims 1-20 as filed April 10, 2025 are under consideration.
The instant application is a continuation (CON) of PCT/US23/76825 filed October 13, 2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 10, 2025 was considered.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
The abstract of the disclosure is objected to because it is not in narrative form. Additionally, the first sentence is incomplete. Correction is required. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 103
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gaertner (US 2022/0040228, published February 10, 2022) in view of Malepati (US 2018/0071352, published March 15, 2018).
Gaertner teaches methods for stopping upper respiratory virus infections comprising the oral administration of zinc and one or more of inter alia vitamins or/and Echinacea (title; abstract; claims; paragraphs [0112], [0114]). The vitamins can include vitamin C and vitamin D (paragraphs [0015], [0065]).
Optimally a subject will eliminate the virus and its symptoms in less than 12 hours after having used the four treatments of Round 1; Round 1 is about 4 hours of treatment (paragraphs [0044], [0083]), as required by instant claims 6, 9, 10, 12, 16, 19, 20.
The quantity of zinc can vary from about 0.1 to 100 mg; the zinc can be formulated into salt (ionizable) forms such as for example zinc gluconate (paragraph [0071]), as required by instant claims 8, 10, 14, 18, 20. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05. Salts include acetates (paragraph [0117]), as required by instant claims 7-10, 13, 14, 17-20.
The quantity of Echinacea can vary from about 1 to 5000 mg (paragraph [0075]).
The quantity of vitamin C can vary from about 1 mg to 5000 mg (paragraph [0078]).
The quantity of vitamin D can vary from about 0.1 to 100 µg (mcg) (paragraph [0079]), as required by instant claims 2, 4.
Gaertner is silent toward antibiotics (whole document), as required by instant claims 5, 9-11, 15, 19, 20.
Gaertner does not specifically teach the Echinacea is a powder form of Echinacea purpurea as required by claims 1 and 3.
This deficiency is made up for in the teachings of Malepati.
Malepati teaches an oral composition comprising Echinacea, vitamin C and zinc; the composition is intended to avoid or shorten viral illnesses such as the common cold and other upper respiratory infections without antibiotics within 5 days (title; abstract; claims; paragraph [0001]). The Echinacea is powdered form of Echinacea purpurea (claim 1). The zinc is zinc acetate (claim 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the powder form of Echinacea purpurea as taught by Malepati for the Echinacea of the compositions of Gaertner because simple substitution of functionally equivalent elements yields predictable results, absent evidence to the contrary.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rondanelli et al. “Self-care for common colds: the pivotal role of vitamin D, vitamin C, zinc, and Echinacea in three main immune interactive clusters (physical barriers, innate and adaptive immunity) involved during an episode of common colds – practical advice on dosages and on the time to take these nutrients / botanicals in order to prevent or treat common colds,” Evidence-Based Complementary and Alternative Medicine 2018:5813095
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISSA PROSSER whose telephone number is (571)272-5164. The examiner can normally be reached M - Th, 10 am - 6 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DAVID BLANCHARD can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISSA PROSSER/
Examiner, Art Unit 1619
/BENNETT M CELSA/Primary Examiner, Art Unit 1600
