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 .
Status of the Application
Claims 15-17 and 19-33 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 09/15/2025 are acknowledged. Claim 15 is amended and new claims 30-33 are added. Claims under consideration in the instant office action are claims 15-17 and 19-33.
Applicants' arguments, filed 09/15/2025, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15-17 and 19-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating the adverse reaction of atorvastatin by administering zaragoic acid, does not reasonably provide enablement for the prevention or treatment of any statin-induced adverse drug reaction. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, "Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue', not 'experimentation'" (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations" (Wands, 8 USPQ2d 1404). Among these factors are: (i) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method of preventing or treating a statin-induced adverse drug reaction comprising administering zaragozic acid. The breadth of the claims thus covers that any adverse reaction from any statin can be treated or prevented by zaragozic acid.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
The state of the art as shown by Danziger et al that many aspects and modalities are involved in the pharmaceutical art, which as a result makes that art highly unpredictable. Pharmacological activity in general is a very unpredictable area. Note that in cases, involving physiological activity such as the instant case, "the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved". Se In re Fisher, 427 F.2d 833,166 USPQ 18, 24 (CCPA 1970).
The article while directed to automated drug design, specifically addresses the issue of steric hindrance which essentially means that the shape, design, including the kinds and amount of substituents greatly affect the ability and efficacy of a drug to bind to the desired receptor and function appropriately.
Regarding statin-induced adverse drug reactions, Simic is drawn towards the adverse effects of statin therapy (see abstract). Simic teaches that there are a number of main adverse effects arising out of statin therapy, including myalgia, myopathy, rhabdomyolysis, liver injury, diabetes mellitus 2, kidney injury, cancers, and cognitive dysfunction (see Fig. 1). Thus, it would be beyond the skill of one of ordinary skill in the art to determine if zaragoic acid is effective against any given statin-induced adverse effect even within the scope of effects resulting in damage to kidney tube cells, nerve cells, and pancreatic cells.
(5) The relative skill of those in the art:
Those of relative skill in the art are those with a level of skill of the authors of the references cites to support the examiner’s position (MD’s or those with advanced degrees and the requisite experience in medicine).
(6) The amount of direction or guidance presented and (7) the presence of absence of working examples:
The specification provides working examples only for the partial amelioration of adverse reactions from the co-administration of avortastatin and oxysterol by administering zaragozic acid (see Example 2). Thus, the specification has only provided working examples with one statin in combination with oxysterol, but not for other statins or avortastatin alone, and has not demonstrated any prevention of developing adverse reactions caused by such statins.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Danziger and Simic above, and the high unpredictability in the art as evidenced therein, and the lack of guidance provided by the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
Response to Arguments
Applicant argues that “The claimed invention treats and/or prevents statin-induced adverse drug reactions by administering zaragozic acid, which counteracts the inhibitory effect of oxysterols on any statin' s HMG-CoA reductase activity. One of ordinary skill in the art would reasonably predict that the disclosure of treating the adverse reaction of atorvastatin by the administration of zaragozic acid is applicable to all statins because of their shared HMG-CoA reductase activity.” The Examiner respectfully disagrees since although Applicant has demonstrated that zaragoic acid can counteract the inhibitory effect of oxysterol when oxysterol is combined with statin therapy, the claimed invention is drawn towards any adverse effect induced by any statin, and thus does not properly enable the entire scope of the claimed invention.
Conclusion
Claims 15-17 and 19-33 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW P LEE/Examiner, Art Unit 1691
/SAVITHA M RAO/Primary Examiner, Art Unit 1691