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 .
The examiner has changed since the previous office action. Examiner Berrios will now be examining this application. Contact information can be found at the end of the office action.
Election/Restrictions
Applicant’s election without traverse of Invention II in the reply filed on 1/10/2026 is acknowledged.
Claim Objections
Claims 9, 10 and 11 are objected to because of the following informalities:
Claim 9, in step 2, recites “to obtain for a first decoction”, it should recite ““to obtain a first decoction”
Claim 9, in step 2, recites “residue solution for twice each for”, it should recite “residue solution twice, each for”
Claim 10 recites “as claim in claim 9” this should recite “as claimed in claim 9”.
Claim 10 recites “20 times of the weight”, this should recite “20 times the weight”.
Claim 10 recites “wherein a time for each of the twice is 60 min” this should recite “wherein the time for decocting the residue solution is 60 min each time”
Claim 10 recites “wherein a time for each of the twice is 90 min” this should recite “wherein the time for decocting the residue solution is 90 min each time”
Claim 11 recites “as claim in claim 9” this should recite “as claimed in claim 9”.
Claim 11 recites “30 times of the weight”, this should recite “30 times the weight”.
Appropriate correction is required.
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 9-12 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.
Claim 9 requires the multi-vitamin material to be made from raw materials and recites “parts by weight” however, the claim fails to define what the part-by-weight are relative too. Are the listed parts by weight relative to the final total weight of the multi-vitamin or based on the weight of the raw material?
Claim 9 recites “prepared rhubarb”, but the claim fails to define how the “prepared rhubarb” is obtained, thus it’s unclear what changes or preparation have to have been applied to the rhubarb for it to be considered “prepared.”
Claims 10-11 do not cure the deficiencies of claim 9 and therefore are deficient for the same reasons.
Claim 12 recites "applying the multi-vitamin to prepare an AIDS adjuvant treatment drug" and it is unclear how a multi-vitamin is applied to prepare a drug. These limitations are confusing for the same reason as just explained, how does one configure a multivitamin to be administered with other drugs. What is required of this limitation? What are the metes and bounds of the limitation and how does one apply a multivitamin to prepare a drug? These limitations are confusing and indefinite.
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.
Claim(s) 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xinqiao (CN 114788859), Bożena (2017), Liu (2015), Foroughinia (2008), Turgumbayeva (2019), Tewtrakul (2006) and KR 20210087406.
Regarding claims 9-11: Xinqiao discloses a multi-vitamin for adjuvant therapy of AIDS (abs). The raw material of the multi-vitamin comprise 4-6 parts champignon peptide, 5-15 parts cordyceps sinensis, 5-15 parts dendrobium officinale, 10-20 parts cooked rheum officinale (reading on prepared rhubarb), 2-4 parts L-carnitine and 3-6 parts of sodium bicarbonate (pg. 3).
Xinqiao teaches the multi-vitamin to be prepared by:
Step 1: adding water into the cordyceps sinensis and the dendrobium candidum (i.e. dendrobium officinale), wherein the water addition amount is 20-30 times of the weight of the cordyceps sinensis, decocting for 150 - 200 minutes, filtering by adopting a 800-mesh filter screen to obtain a mixed nutrient solution, then placing the nutrient solution into a fermentation tank, adding mucor and brown sugar for fermentation, adding the mucor with the amount of 0.25-0.65% of the weight of the mixed nutrient solution, adding the brown sugar with the amount of 5-8% of the weight of the mixed nutrient solution, taking out after fermenting for 80-100 days, adding absolute ethyl alcohol with the amount of 30-50% of the weight of the mixed nutrient solution, standing for 12-24 hours, filtering to obtain a filtrate, concentrating and drying to obtain a standby material;
Step 2: adding water into the cooked rhubarb, decocting for 60-120 minutes, and filtering to obtain a first decoction filtrate, wherein the water addition amount is 4-8 times of the weight of the cooked rhubarb; decocting the residue with 3-6 times of water for 60-90 min for 2 times, filtering, mixing the filtrates, concentrating, and drying to obtain extract; and
Step 3: uniformly mixing the standby material obtained in the first step with the cooked rhubarb extract obtained in the second step, and adding the champignon peptide, the L-carnitine and the sodium bicarbonate to obtain the multivitamin (pg. 7).
While Xinqiao doesn’t specify the parts of the raw material to be parts by weight, the methods of preparation refer to everything by weight, as such it’s reasonable to expect that the ingredients listed in the raw materials above are also in parts by weight.
Steps 1-3 of Xinqiao discussed above read on steps 1-3 claimed as it recites concentrations and timeframes that overlap with those claimed and overlapping ranges are prima facie obvious in the absence of evidence to the contrary, however, Xinqiao does not teach the multi-vitamin raw material to comprise the required radix paeoniae alba, safflower, rhizome dioscoreaea, angelica sinensis and teachings using champignon peptide instead of shiitake peptide.
Regarding the inclusion of the shiitake peptide: Bozena teaches that polysaccharides contained in shiitake extract have strong antitumor, antiviral and antiviral properties. The extract include mannopeptide (pg. 189). The HIV virus was found to have susceptibility to the shiitake extracts (pg. 193), aqueous L.edpdes extract (i.e. shiitake extract) inhibited the cytopathic HIV effects and HIV leads to AIDS (pg. 194). It would have been prima facie obvious to add shiitake extract (reading on shiitake peptides) to the multi-vitamin in addition to the champignon peptide as the prior art teaches shiitake extract containing peptides to be effective at inhibiting cytopathic effects of HIV which leads to AIDS and Xinqiao teaches the multi-vitamin to be used as an adjuvant for AIDS treatment and teaches the inclusion of mushroom peptides.
Regarding the inclusion of radix Paeonia alba and angelica sinensis: Liu teaches that treatment of AIDS/HIV in China include herbal preparations including those that include radix paeoniae alba and angelica sinensis (pg. 2-3). Foroughinia teaches that angelica sinensis may provide protection against HIV infection (abs).It would have been prima facie obvious to add radix paeoniae alba, angelica sinensis and/or any of the other herbs taught to the multi-vitamin of Xinqiao as Xinqiao teaches composition to treat AIDS which is caused by HIV infection and radix paeoniae alba and angelica sinensis are taught to a suitable herbs for use in AIDS treatments which may provide protection against HIV infection.
Regarding the inclusion of safflower: Turgumbayeva teaches that Carthamus tinctorius (i.e. safflower) may contain active agents for cryptococcal infections (abs). Turgumbayeva teaches that cryptococcal infections occur in patients with immunosuppression (i.e. in HIV patients) (pg. 138). It would have been prima facie obvious to add safflower into the multi-vitamin of Xinqiao as Xinqiao teaches composition to treat AIDS which is caused by HIV infection and safflower is taught to be effective at treating cryptococcal infections which occur in HIV patients, as such a skilled artisan would be motivated to formulate an improved multi-vitamin that treats additional side effects of HIV.
Regarding the inclusion of rhizome dioscoreae: Tewtrakul teaches that extract of Dioscorea membranacea (rhizomes were used) showed appreciable activity against HIV (pg. 312) with a HIV-1 PR inhibitory effect and substantiated the basis for its use in AIDS treatment. It would have been prima facie obvious to add rhizome dioscoreae the multi-vitamin of Xinqiao as Xinqiao teaches composition to treat AIDS which is caused by HIV infection and rhizome dioscoreae taught to be effective at inhibiting HIV-1 PR and is said to be suitable for use in AIDS treatment.
As discussed above, radix paeoniae alba, safflower, rhizome dioscoreaea, angelica sinensis and shiitake peptide are known in the art to either be used in herbal preparations for AIDS treatment or are showing the art to be effective against treating HIV Infection or infections caused by the HIV virus.
However, the above references do not teach adding the radix paeoniae alba, safflower, rhizome dioscoreaea and the angelica sinensis in the 2nd step of Xinqiao along with the cooked rhubarb, however it must be remembered that any order of performing process steps (i.e. such as adding ingredients) is prima facie obvious absent evidence of criticality.
Regarding the claimed parts by weight, as discussed above, the prior art makes obvious the part by weight of various ingredients, but is silent to the amounts of radix paeoniae alba, safflower, rhizome dioscoreaea, angelica sinensis and shiitake peptide.
KR’406 teaches that the effective amounts of plant extracts vary depending on the form in which the composition is commercialized, the method in which the compound is applied to the skin, and the time it stays on the skin. For example, when the composition is commercialized as a pharmaceutical formulation, it may contain the plant extract at a higher concentration than when commercialized as a cosmetic that is applied to the skin on a daily basis. As such it would have been prima facie obvious to a skilled artisan to optimize the amount of each plant component present in the multi-vitamin based on its final form and the desired effect desired to be obtained (i.e. effective to treat HIV).
Regarding claim 12: Xinqiao teaches the use of the multi-vitamin in the preparation of a medicament for the adjuvant treatment of AIDS (pg. 13).
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at (571) 272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
