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 .
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 10/14/2025 is acknowledged.
The applicant has canceled claims 1-8 and 15-20 in the response filed on 10/14/2025.
Claims 9-14 are being examined on the merits.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 9-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by He Xinqiao (CN114887052A).
Xinqiao discloses a preparation method of the multi-vitamin comprises the following steps: the first step is as follows: adding water into Coptis leaves, Silybum marianum, ginger, Cordyceps sinensis, Dendrobium officinale, red ginseng and Eucommia male flowers, adding water in an amount which is 30 times of the weight of the Cordyceps sinensis, decocting for 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 mucor in an amount which is 0.65 percent of the weight of the mixed nutrient solution, adding brown sugar in an amount which is 8 percent of the weight of the mixed nutrient solution, taking out after 100 days of fermentation, adding absolute ethyl alcohol in an amount which is 50 percent of the weight of the mixed nutrient solution, standing for 24 hours, and filtering to obtain a filtrate for later use; the second step is that: and (3) mixing the filtrate obtained in the first step with gamma-globulin, non-transgenic soybean lecithin, camellia oil, sea buckthorn seed oil, mushroom peptide, amino acid, isomaltooligosaccharide, xylitol, nano zinc oxide and bovine bone collagen peptide, and uniformly stirring to obtain the multivitamin (see claim 4).
Regarding claims 10-11, Xingqiao discloses that the multivitamin is for both the auxillary regulation of blood pressure (see title, and technical field) and teaches the drug is for lowering blood pressure (see page 10, last para.).
Regarding claim 12, Xinqiao discloses “The multivitamin of claim 1, wherein the raw materials of the multivitamin comprise: 4-6 parts of coptis leaves, 5-15 parts of silybum marianum, 5-15 parts of ginger, 5-15 parts of cordyceps sinensis, 5-15 parts of dendrobium officinale, 5-15 parts of red ginseng, 5-15 parts of eucommia male flowers, 10-20 parts of gamma globulin, 10-20 parts of non-transgenic soybean lecithin, 20-40 parts of camellia oil, 10-20 parts of sea buckthorn seed oil, 4-6 parts of champignon, 4-6 parts of amino acid, 5-15 parts of isomaltooligosaccharide, 5-15 parts of xylitol, 0.4-0.6 part of nano zinc oxide and 4-6 parts of bovine bone collagen peptide” (see claim 2).
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 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over He Xinqiao (CN114887052A) and P. Trankwalder et. al. (Amlodipine Besylate versus Candesartan Cilexetil in Hypertensive Patients- Office and Self-Measured Blood Pressure, A Randomised, Double-Blind, Comparative Multicentre Trial, Clin Drug Invest 2005; 25 (9)).
Xinqiao teaches a preparation method of the multi-vitamin comprises the following steps: the first step is as follows: adding water into Coptis leaves, Silybum marianum, ginger, Cordyceps sinensis, Dendrobium officinale, red ginseng and Eucommia male flowers, adding water in an amount which is 30 times of the weight of the Cordyceps sinensis, decocting for 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 mucor in an amount which is 0.65 percent of the weight of the mixed nutrient solution, adding brown sugar in an amount which is 8 percent of the weight of the mixed nutrient solution, taking out after 100 days of fermentation, adding absolute ethyl alcohol in an amount which is 50 percent of the weight of the mixed nutrient solution, standing for 24 hours, and filtering to obtain a filtrate for later use; the second step is that: and (3) mixing the filtrate obtained in the first step with gamma-globulin, non-transgenic soybean lecithin, camellia oil, sea buckthorn seed oil, mushroom peptide, amino acid, isomaltooligosaccharide, xylitol, nano zinc oxide and bovine bone collagen peptide, and uniformly stirring to obtain the multivitamin (see claim 4).
Regarding claims 10-11, Xingqiao teaches that the multivitamin is for both the auxillary regulation of blood pressure (see title, and technical field) and teaches the drug is for lowering blood pressure (see page 10, last para.).
Regarding claim 12, Xinqiao teaches “The multivitamin of claim 1, wherein the raw materials of the multivitamin comprise: 4-6 parts of coptis leaves, 5-15 parts of silybum marianum, 5-15 parts of ginger, 5-15 parts of cordyceps sinensis, 5-15 parts of dendrobium officinale, 5-15 parts of red ginseng, 5-15 parts of eucommia male flowers, 10-20 parts of gamma globulin, 10-20 parts of non-transgenic soybean lecithin, 20-40 parts of camellia oil, 10-20 parts of sea buckthorn seed oil, 4-6 parts of champignon, 4-6 parts of amino acid, 5-15 parts of isomaltooligosaccharide, 5-15 parts of xylitol, 0.4-0.6 part of nano zinc oxide and 4-6 parts of bovine bone collagen peptide” (see claim 2).
Xinqiao teaches the instantly claimed method however is silent on the administration of a hypertensive in combination with the multivitamin.
Trankwalder teaches that “a total of 294 patients (151 amlodipine and 143 candesartan cilexetil) were included in the per-protocol analysis of the primary endpoint of BP change from baseline at 12 weeks. Reductions in sitting office systolic BP (SBP) [amlodipine 24.4mm Hg, candesartan cilexetil 22.3mm Hg] and DBP (amlodipine 14.9mm Hg, candesartan cilexetil 14.8mm Hg) were statistically equivalent within the chosen range of equivalence (5mm Hg for SBP and 3mm Hg for DBP). The proportion of controlled patients (office BP <140/90mm Hg) at the end of therapy was similar in both treatment groups (amlodipine 46.9%, candesartan cilexetil 44.4%). The reduction in self-measured DBP was significantly greater (p < 0.05) for amlodipine (7.2mm Hg) compared with candesartan cilexetil (4.8mm Hg)” (see results, abstract, page 567).
Therefore it would have been obvious to persons having ordinary skill in the art and before the effective filing date to administer amlodipine besylate tablets in conjunction with the multivitamin taught by Xinqiao because both are taught to be useful for the same purpose. It is prima facie obvious to combine equivalents known for the same purpose.
Conclusion
Currently no claims are allowed.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655