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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/05/2026 is being considered by the examiner. The signed IDS form is attached with the instant office action.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application on 09/11/2023.
Response to Amendment
Applicant's amendment and argument filed 03/05/2026, in response to the non-final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 8-18 are being examined on the merits.
Claim Rejections - 35 USC § 102
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 8-10, 12-13 and 15-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wehand (From IDS filed on 03/05/2026, CN111658692A). This is a new rejection based on the amendments filed on 03/05/2026.
Regarding claim 8, Wehand discloses the invention relates to the application of mulberry extract in the preparation and treatment of abnormal glucose and lipid metabolism in mammals and the diseases caused by it, characterized in that, the plant extract is prepared according to the following steps: step 1), preparing a crude extract; step 2 ), separated by cation resin and/or optional anion resin; step 3), alcohol precipitation treatment of the resin effluent in step 2); optional step 4), concentration and drying (see abstract).
Wehand discloses wherein the diseases the composition is intended to treat is obesity (see claim 9).
Wehand discloses “take 1000kg of fresh mulberry branches (Yuesang No. 11), crush, add 4000L of water, extract by heating and reflux method for 2h, combine the extracts, filter to remove insolubles, and obtain a crude extract. The crude extract was thermally concentrated to a solid content of 4% and used as the loading solution for the cation resin column” (see preparation example 1, page 3). Here Wehand discloses the same steps as what is being claimed.
Regarding claims 8, 15-17, Wehand discloses the amount of “In the obtained mulberry branch extract, the content of alkaloids is 75%, the content of polysaccharides is 15%, the content of flavonoids is 0.7%, and the content of amino acids is 5%” all of which are within the instantly claimed ranges.
Regarding claim 9, Wehand discloses wherein the mammals are humans and rodents (see claim 4).
Regarding claim 10, Wehand discloses the treatment is intended for diabetes (see abstract).
Regarding claim 12, Wehand discloses a pharmaceutically acceptable carrier (see claim 6).
Regarding claims 13 and 18, Wehand discloses “Preferably, the drug is administered orally. Further preferably, the dosage form of the medicine is selected from capsules, tablets, oral solutions, oral emulsions, pills, granules, syrups and powders”.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 8-18 are rejected under 35 U.S.C. 103 as being unpatentable over Wehand (From IDS filed on 03/05/2026, CN111658692A). This is a new rejection based on the amendments filed on 03/05/2026.
Wehand discloses the invention relates to the application of mulberry extract in the preparation and treatment of abnormal glucose and lipid metabolism in mammals and the diseases caused by it, characterized in that, the plant extract is prepared according to the following steps: step 1), preparing a crude extract; step 2 ), separated by cation resin and/or optional anion resin; step 3), alcohol precipitation treatment of the resin effluent in step 2); optional step 4), concentration and drying (see abstract).
Wehand discloses wherein the diseases the composition is intended to treat is obesity (see claim 9).
Wehand discloses “take 1000kg of fresh mulberry branches (Yuesang No. 11), crush, add 4000L of water, extract by heating and reflux method for 2h, combine the extracts, filter to remove insolubles, and obtain a crude extract. The crude extract was thermally concentrated to a solid content of 4% and used as the loading solution for the cation resin column” (see preparation example 1, page 3).
Wehand discloses the amount of “In the obtained mulberry branch extract, the content of alkaloids is 75%, the content of polysaccharides is 15%, the content of flavonoids is 0.7%, and the content of amino acids is 5%” all of which are within the instantly claimed ranges.
Wehand does not specifically teach that the animals to be treated are healthy or that they have a BMI greater than or equal to 28, however these limitations are prima facie obvious given the prior art.
Therefore it would have been obvious to persons having ordinary skill in the prior art to administer the method of treatment to healthy animals and to ones which have a BMI greater than or equal to 28 because Wehand teaches that the method of treatment is for treating obesity and thus it is obvious to administer the treatment to a human who needs to reduce their BMI and to humans are healthy. Healthy individuals would take the treatment to lose weight and so would persons with a BMI of 28 or greater.
There would have been a reasonable expectation of success in arriving at the instant invention given the relied upon art.
Response to Arguments
Applicant's arguments filed 03/05/2026 have been fully considered but they are not persuasive. The applicant argues that Wehand (CN1631246A) does not disclose each and every limitation of the instant invention. The Office relies on a different Wehand document (CN111658692A) in the current rejection. Wehand (CN11658692) indeed anticipates the instant claims because Wehnad teaches of a method for treating obesity (reducing weight) in an animal by administering an effective amount of mulberry extract which has the required number of amino acids, alkaloids, flavonoids and polysaccharides. The applicant argues that Wehand teaches a different mulberry extract because it is an alcohol solvent used and one that does not require a resin exchange with alcohol precipitation. Again, the applicant argues a different Wehand document than what is currently relied upon. The applicant also argues against Shandong, however this art is no longer relied upon for the current rejection, due to the current claim amendments.
Conclusion
Currently no claims are allowed.
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.
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JACOB A BOECKELMANExaminer, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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