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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 .
Amended claims 1, 4-9, 11, 12 are pending.
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, 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.
Previously presented rejection of claim(s) 1, 4-9, 11, 12 are rejected under 35 U.S.C. 103 as being unpatentable over Hu WO2017088213; Wang, Nat. Prod. Bioprospect. (2015) 5:237–246; Geethangili, Evidence-Based Complementary and Alternative Medicine Volume 2011, Article ID 212641, 1-17; Wong, Volume 3, Issue 5, May 1999, Pages 543-553; and Korn, “Dose optimization during drug development: whether and when to optimize” J Natl Cancer Inst. 2022 Dec 19;115(5):492–497.
Wong and Korn are added to the rejection statement in response to Applicant’s arguments.
Applicant’s arguments focus on the amendments to claims:
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Response:
Amendments to claims and applicants arguments are not persuasisive to overcome the rejection.
The active ingredients in the claimed method are known in the art.
The use of using the said active ingredients for treating the diseases in the claimed method is known in the prior art.
Examination guidelines regarding the amount/concentration administered is clear as shown below:
It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[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). (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). see MPEP § 2144.05 part II A. Although the prior art did not specifically disclose the amounts of each constituent, it would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal concentrations of components because concentrations of the claimed components are art-recognized result effective variables because they have the ability for controlling parasites, which would have been routinely determined and optimized in the pharmaceutical art.
Examination guidelines as to the position taken is also predicated on the following:
As per MPEP 2112 Requirements of Rejection Based on Inherency; Burden of Proof [R-10.2019], "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer."
The new use must be novel as to the use directed and unobvious. The new use (if any) must account for the possibility that the underlying mechanism for the new therapy is the same mechanism that allows for a prior art treatment using the same compound (or its obvious version).
The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the applicants had merely found a new property of the From compound and such a discovery did not constitute a new use.
As to Applicant’s conclusion “…a skilled person that compound (I) and (II) are the basis for the efficacy of these extracts and therefore, absent hindsight, a skilled person would not seek to optimize the concentration of these compounds. Thus, there is no motivation to combine the applied references…”
Art acknowledged basic principle of toxicology is "The dose makes the poison".
The goal of dose optimization during drug development is to identify a dose that preserves clinical benefit with optimal tolerability. For example, Korn teaches Dose optimization during drug development: whether and when to optimize.
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office
Accordingly, the claims do not recite an unobvious distinction over the prior art. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art. Accordingly, the claims are rejected under 35 U.S.C. § 103.
Following is from previous action:
Wang teaches compounds antcin compound from Antrodia cinnamomea. See page compounds of instant claim 3 in Fig 1 (first structures) at page 239. According to Wang, page 238 column A, Antrodia cinnamomea (or A. camphorata, Polyporaceae family, known as ‘‘Niu-Chang-Chih’’ in Chinese) is a precious medicinal mushroom. It has been reported to exhibit anticancer, antioxidant, anti-inflammatory, anti-angiogenesis, liver protection and radioprotection activities.
Hu discloses a method of treating a liver disease or disorder in a subject in need thereof (machine translation - pg. 2, In 60-62: treatment of drug-induced liver injury), the method comprising: administering (pg. 4, In 158-159: oral administration) to the subject a therapeutically effective amount of antcin H in preparing drugs for treating and preventing drug-induced liver injury (see Abstract). For structure of antcin compounds see pages, 2, 4, 8, 9.
Geethangili reference is Review of Pharmacological Effects of Antrodia camphorata and
Its Bioactive Compounds. The bioactive compounds pictured at page 4 Table include the instantly pictured compounds. Starting at page 3, column A, Geethangili teaches the plethora of possible diseases (see claim 5) that could be treated with the said compounds. Claims 6-10 could also be interpreted as being drawn to dose(s) of the previously known compounds for the same previously known diseases. For example, claim 6 is drawn to the known biological property of the endogenous bile acid. According to Wong, CDCA and FRX are linked inexorably; CDCA is selectively activates the orphan nuclear receptor. See Wong starting at pages 546 column B section under Bile acids activate FXR, Bile Acids Are FXR Ligands onto page 351 column A.
As such the difference between the prior art teaching and instantly claimed method is in the language relating to FXR and other biological property (see claim 1, 6-8).
The position taken is that the above difference relates to the inherent property of the compounds from Antrodia cinnamomea.
As per disclosure the compounds such as the ones of claim 3 are useful for treating any and all diseases selected from selected from a liver disease, obesity, diabetes, diarrhea, abdominal pain, hypertension, itchy skin, liver cancer, hepatitis, biliary cholangitis, nonalcoholic steatohepatitis, primary sclerosing cholangitis, inflammation, and fibrosis.
The cited reference independently teach that these compounds are known to be useful for treating these diseases
As per MPEP 2112 Requirements of Rejection Based on Inherency; Burden of Proof [R-10.2019], "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer."
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
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