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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/06/2026 has been entered.
Claims Status
The remarks filed 04/06/2026 are acknowledged.
Claims 35, 72-84, and 86-91 are pending.
Claims 1-34, 36-71, and 85 are cancelled.
Withdrawn
The rejections of claims 35, 72-84, and 86-91 under 35 U.S.C. 103 are withdrawn. Applicant has filed arguments and a declaration that demonstrate sufficient unpredictability in the combination of the claimed drugs (i.e. levetiracetam, atorvastatin and ceftriaxone) for treating epileptogenesis and are persuasive to overcome a prima facie case of obviousness.
Claim Rejections - 35 USC § 112(a)
Scope of Enablement
Claims 35, 72-84, and 86-91 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 a method of treating epileptogenesis in a human after a brain insult, the method comprising administering to the human a therapeutically effective amount of a therapeutic combination comprising levetiracetam, atorvastatin or a pharmaceutically acceptable salt thereof, and ceftriaxone or a pharmaceutically acceptable salt thereof, wherein the levetiracetam, atorvastatin, and ceftriaxone are administered at a dose of 90/4.5/90 mg/kg/day or 60/3/60 mg/kg 3 times daily, respectively, does not reasonably provide enablement for administering the combination of drugs at any other dosage in order to treat epileptogenesis. 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.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and
Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008). See also In re Cortright, 49 USPQ2d 1464, 1466 and Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer Inc., 49 USPQ2d 1370.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: (1) the nature or the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. When the above factors are weighed, it is the examiner’s position that one skilled in the art could not practice the invention without undue experimentation. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
(1) The nature of the invention and (5) The breadth of the claims:
The claims are directed to a method of treating epileptogenesis in a human after a brain insult, the method comprising administering to the human a therapeutically effective amount of a therapeutic combination comprising levetiracetam, atorvastatin or a pharmaceutically acceptable salt thereof, and ceftriaxone or a pharmaceutically acceptable salt thereof. Claims 75-77 and 89-91 further limit the dose of each of the three drugs.
The claims are broad and inclusive of treating epileptogenesis comprising administering any amount of each of levetiracetam, atorvastatin or a pharmaceutically acceptable salt thereof, and ceftriaxone pharmaceutically acceptable salt thereof. The instant specification does not provide any evidence that any dose of each of levetiracetam, atorvastatin, and ceftriaxone would treat epileptogenesis. Therefore, it would require undue experimentation to determine which doses would be effective in treating epileptogenesis.
(F) The amount of direction provided by the inventor, (G) The existence of working examples:
There is a lack of working examples in the specification for treating epileptogenesis comprising administering any amount of each of levetiracetam, atorvastatin or a pharmaceutically acceptable salt thereof, and ceftriaxone pharmaceutically acceptable salt thereof. There are no examples of administering the claimed combination of levetiracetam, atorvastatin or a pharmaceutically acceptable salt thereof, and ceftriaxone pharmaceutically acceptable salt thereof to treat epileptogenesis.
(C) The state of the prior art, (E) The level of predictability in the art:
The field of treatment for neurological disorders is highly unpredictable. Applicant has filed arguments and a declaration pointing out the unpredictability of administering levetiracetam, atorvastatin, and ceftriaxone for the treatment of epileptogenesis. In paragraphs 6-9 of the declaration, Declarant points out the unpredictability of animal models and the ability to study epileptogenesis, and that the teachings of Chen et al., 2016 (02/12/2025 PTO-892) merely speculate that levetiracetam may decrease epileptogenesis. Further, paragraphs 11-13 of the declaration cite the references of Brandt and Schidlitzki, which teach away from the use of levetiracetam for an antiepileptogenic agent. Paragraphs 21-22 of the declaration emphasize the proconvulsant risks associated with cephalosporins, such as ceftriaxone, citing the teachings of Sander and Loscher as a teaching away from the use of ceftriaxone for an antiepileptogenic agent. In support of the unpredictability relating to the doses of each of levetiracetam, atorvastatin, and ceftriaxone in a method of treating epileptogenesis, both the arguments and declaration cite Welzel et al., 2021 (05/06/2025 IDS), which teaches that the administration of levetiracetam, atorvastatin, ceftriaxone at doses of 200/10/200 mg/kg, respectively, 3 times daily (treatment group D) [page 3; Table 1] did not exert any antiepileptogenic effects but rather exhibited proepileptogenic activity [page 4, right column, third paragraph].
Nonetheless, both the declaration (see paragraphs 25-30) and the arguments (see pages 12-14 of the remarks) cite the post-filing art teachings of Hameed et al., 2023 (05/21/2024 IDS) and Welzel et al., 2021 (05/06/2025 IDS) to support the enablement of treating epileptogenesis comprising administering levetiracetam, atorvastatin, and ceftriaxone at the specific doses of 90/4.5/90 mg/kg/day [see Hameed] or 60/3/60 mg/kg 3 times daily, respectively, [see Welzel; Table 1 and page 8, right column, first paragraph].
In conclusion, the claimed invention does not provide enablement for treating epileptogenesis in a human after a brain insult, the method comprising administering to the human a therapeutically effective amount of a therapeutic combination comprising levetiracetam, atorvastatin or a pharmaceutically acceptable salt thereof at any dosage as encompassed by the instant claims. Thus for the reasons outlined above, the specification is not considered to be enabling for one skilled in the art to use the claimed invention as the amount of experimentation required is undue, due to the broad scope of the claims, and the lack of guidance and working examples provided in the specification. Therefore, the specification is not representative of the instant claims and the specification is not fully enabled for the instant claims. In view of the above, one of skill in the art would be forced into undue experimentation to practice the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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