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 amendment filed 17 February 2026 is acknowledged and has been entered.
Status of the claims
Claims 1-13, 15 and 20-23 have been cancelled.
Claims 14, 16-19 and 24-30 are presented for examination on the merits.
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 14, 16-19 and 24-30 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 14 is rendered vague and indefinite by the phrase “crushing mulberry twigs (Ramulus Mori) for extraction with water and/or acid water under extraction”. It is unclear what is mean by “under extraction”. Does this mean under pressure? Under heating?
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.
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) 14, 16-19 and 24-30 are rejected under 35 U.S.C. 103 as being unpatentable over Peng et al. (2017) or Yang et al. (2018) in view of Wang et al. (2020).
Peng et al. beneficially disclose that mulberry (Morus alba) leaf has been used in Chinese medicine as the remedy for hyperlipidemia and metabolic disorders and mulberry leaf extract (MLE) attenuates dyslipidemia and lipid accumulation in high fat diet (HFD)-fed mice. Non-alcoholic fatty liver (NAFLD) is generally considered as the liver component of metabolic syndrome. The hepatic lipid infiltration induces oxidative stress, and is associated with interleukin-6 (IL-6) and tumor necrosis factor-a (TNF-a) which are regulated by the leptin and adiponectin. MLE could prevent obesity-related NAFLD via downregulating the lipogenesis enzymes while upregulating the lipolysis markers. Treatment of MLE, especially at 2%, enhanced the expression of superoxide dismutase (SOD) and clenched the oxidative stress of liver. MLE decreased the plasma level of leptin but increased adiponectin. The advantage of MLE is supposed mainly attributed to chlorogenic acid derivative. We suggest MLE, with promising outcome of research, could be nutraceutical to prevent obesity and related NAFLD.
Yang et al. (2018) beneficially disclose that mulberry is known to have pharmacological effects against cholesterol, obesity, and dyslipidemia. Many studies have revealed that mulberry leaf possesses hepatoprotective properties against nonalcoholic fatty liver disease (NAFLD); however, mulberry fruit is less studied in this context. Therefore, this study aimed to investigate the preventive effects of mulberry fruit against high fat diet- (HFD-) induced NAFLD. To evaluate the effects of mulberry fruit on NAFLD, two doses of mulberry fruit ethanol extracts [MB, 100, and 200 mg/kg BW (body weight)] were given to HFD-fed rats for 10 weeks. MB dramatically prevented liver damage as shown by biochemical analysis of the liver injury markers, alanine transaminase, and aspartate transaminase. MB treatment significantly inhibited the increased levels of total cholesterol, triacylglycerol, and low-density lipoprotein-cholesterol but restored the level of high-density lipoprotein-cholesterol in HFD-fed rats. Notably, histological analysis of liver tissues demonstrated that MB substantially ameliorated lipid accumulation. Expression of cholesterol-regulating genes was also suppressed by MB treatment. For its underlying mechanisms, MB suppressed hepatic reactive oxygen species (ROS) overproduction and mitochondrial oxidative stress in HFD-fed rats. MB potentially protects liver tissue against NAFLD by inhibition of itochondrial oxidative stress, suggesting its possible use as a therapeutic agent for treatment of NAFLD.
Wang et al. disclose that administration of mulberry leaf extract with 93.57% alkaloids can show hepatic protective effects. It was concluded that mulberry alkaloids can improve hepatic fibrosis possibly as result of antioxidant and anti-inflammatory effects.
Thus is would appear from the cited references that it was well known in the prior art at the time of filing of the application that mulberry extracts high in alkaloids could be effective in treating NAFLD. Thus is would have been obvious to one of ordinary skill in the art at to administer to a subject in need thereof.
With reference to the mechanism of action of the extract, such is deemed a consequence of the administration of the mulberry extract to the subject, which is the only positively recited step of the claimed method. These recitations do not effectively limit the claimed method of treatment (see Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F. 3d 1373 (Fed. Cir. 2003) ( “clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.”)).
The adjustment of particular conventional working conditions (e.g., determining an appropriate daily dose thereof and/or employing one or more commonly-employed means of administration, etc.) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Applicant’s invention appears predicated on an unexpected result, which typically involves synergism - an unpredictable phenomenon, highly dependent upon specific proportions and/or amounts of particular ingredients. Accordingly, the instant claims, in the range of proportions where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him/her.
Response to Arguments
Applicant’s amendments/arguments, with respect to the written description rejection have been fully considered and are persuasive. The 35 USC 112(a) rejection of the previous Office action has been withdrawn.
Applicant's amendments/arguments filed with respect to the 35 USC 103 rejection have been fully considered but they are not persuasive.
Applicant's arguments (including those within the 132 Declaration) with respect to the 35 USC 103 rejections have been fully considered but they are not deemed persuasive. Applicant argues that the claimed composition is different than that suggested by the cited prior art references. However, conclusory statements by the Applicant are not a substitute for evidence, particularly surprising or unexpected results. Applicant’s arguments are essentially contained within the 132 Declaration, so response will be directed thereto.
Firstly, the Chen reference was cited for the revelation that the extract Ramulus Mori (Sangzhi) alkaloids (SZ-A) from Morus alba L. employed in the instant Application was approved in 2020 for the treatment of T2DM. Consequently, the extract of the claims was known to the public in 2020, which predates the effective filing date of the instant Application.
The Declaration points out the superior results of the high-alkaloid extract of mulberry (i.e., Sangzhi) compared to the cited references. However, with respect to such unexpected results, please note that in KSR, the Court also reaffirmed that evidence of unexpected results may overcome an examiner's prima facie case of obviousness. KSR, 550 U.S. at 416 ("The fact that the elements worked together in an unexpected and fruitful manner supported the conclusion that Adams' design was not obvious to those skilled in the art" - discussing United States v. Adams, 383 U.S. 39). However, "any superior property must be unexpected to be considered as evidence of non-obviousness." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). Thus, "[m]ere improvement in properties does not always suffice to show unexpected results ....[W]hen an applicant demonstrates substantially improved results.., and states that the results were unexpected, this should suffice to establish unexpected results in the absence of evidence to the contrary." In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995). Moreover, in order to establish unexpected results for claimed invention, objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support. In re Greenfield, 571 F.2d 1185, 1189 (CCPA 1978). Please also note that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer v. Apotex, 480 F.3d at 1368. The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)).
Furthermore, it is not clear why it was surprising or unexpected to find that the mulberry extract with high levels of alkaloids would have beneficial hepatoprotective effects, see e.g., attached Wang et al. references, which disclose the hepatoprotective effects of alkaloids from mulberry.
Thus it is concluded that the claimed method of treating liver diseases such as hepatic fibrosis which employs a known mulberry extract with high levels of alkaloids would have been well within the purview of the skilled practitioner, as mulberry extracts are known in the prior art to have hepatoprotective effects.
Accordingly, the instant claims, where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him/her.
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.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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/RUSSELL G FIEBIG/Examiner, Art Unit 1655