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 .
Specification
The disclosure is objected to because of the following informalities:
The use of the terms Cryovial®, Cardice®, LabDiet®, Kolliphor®, and Microsoft® Excel® which are a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph
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.
Claim 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 5 recites a duration of “about 30 minutes”. However, the originally filed specification and claims do not disclose or describe a duration or range that would reasonably convey possession of the recited “about 30 minutes” limitation at the time of filing. Accordingly, the recited duration constitutes subject matter that was not originally disclosed, and therefore amounts to impermissible new matter.
Clarification and/or amendment is required.
Claim Rejections - 35 USC § 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
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.
Claim 5 is 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.
Regarding claim 5, the phrase "about" renders the claim indefinite because the boundaries of the claim following the phrase are unclear. The specification does not provide standard for determining the scope or degree of approximation implied by this relative term. One of ordinary skill in the art would not understand the metes and bounds of the claimed subject matter when the claim is read in light of the specification. See MPEP § 2173.05(b).
Clarification and/or amendment is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature and/or natural phenomenon without significantly more. The claim 1 recite a method of assessing the pro- or anti-convulsant properties of a test compound, and the claims 2-11 recite further limitations of the method by specifying the number of animals used, the scale of current adjustment, post-dose timing, positive control compounds, and animals used. The claimed steps of administering a compound, applying electroshock, and observing whether a conclusive response occurs merely observe and evaluate a natural physiological reaction. The claimed steps show the natural relationship between administration of a compound and a convulsive or anticonvulsant physiological response. The claimed “assessing” and “determining” steps are directed to collecting information about a natural biological response, rather than performing a technological process. Accordingly, the claims are directed to a judicial exception.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements of the claims, considered individually and as an ordered combination, do not amount to significantly more than the identified judicial exception. The steps of dosing animals with a compound, applying electroshock, observing convulsive behavior, and adjusting stimulation parameters are well-understood, routine, and conventional experimental techniques in the field of pharmacological screening and seizure testing. The recitation of a minimum or maximum number of animals, logarithmic adjustment of current, and defined post-dose observation periods constitutes experimental design choice and data-gathering limitations, which do not add an inventive concept. The claims do not recite any technological improvement such as an improvement to electroshock apparatus, a new stimulation mechanism, a new compound, or a new method of treating disease. Instead, the claims merely apply known experimental techniques to observe a natural response, which is insufficient to confer patent eligibility.
The claims also risk preempting the use of the natural relationship between compound administration and convulsive response, as they broadly cover methods of evaluating anticonvulsant properties using electroshock-based animal testing.
Therefore, the claims 1-11 are not patent-eligible under 35 U.S.C. 101 because they are directed to a judicial exception and do not recite additional elements sufficient to amount to significantly more than the exception.
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.
Claim(s) 1 and 3-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Löscher et al. (Epilepsy Res. 1991; cited on IDS filed February 28, 2024).
Regarding claim 1, Löscher 1991 discloses a method evaluating anti-convulsant drugs comprising steps: a. dosing a number of animals with either the anti-convulsant drugs (a test compound or a positive control compound) or a vehicle control (page 81, Seizure tests used; Fig. 1), b. determining if the animals produce a tonic hind limb extensor convulsion at a defined period of time post-dose from a single electroshock at a defined current using maximal electroshock seizure threshold (MEST) test (page 81, Seizure tests used), c. decreasing or increasing the defined current if the preceding animal did or did not produce show tonic hind limb extensor convulsion, respectively using up-and-down method (page 81, Seizure tests used), and d. collecting CC50 (a current to produce tonic hind limb extension in 50% of animals in the treatment group) values for the treated animals (page 81, Seizure tests used; Fig. 1). Löscher 1991 also discloses that groups of 15-20 animals are used to calculate CC50 (page 81, Seizure tests used; Fig. 1), which reads on the number of animals used is at least 6 of instant claim 1.
Regarding claim 3, Löscher 1991 discloses that the current of the electroshock is decreased or increased using 0.6 log intervals (reads on logarithmic scale) for the up-and-down method (page 81, Seizure tests used).
Regarding claims 4-6, Löscher 1991 discloses anti-convulsant effect of carbamazepine at 0, 5, 15,30, 60, 120, and 180 minutes after the administration (Fig. 1), which reads on the defined period of time post-dose is at least 15 minutes, about 30 minutes, or 120 minutes of instant claims.
Regarding claims 7 and 8, Löscher 1991 discloses that diazepam and valproate (as sodium salt) are used as anti-convulsant drugs (page 83, Drugs and drug formulations; Fig. 1).
Regarding claims 9 and 10, Löscher 1991 discloses that mice and rats are used as animals (page 81, Animals; Fig. 1; Fig. 2).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Löscher et al. (Epilepsy Res. 1991; cited on IDS filed February 28, 2024) in view of Löscher et al. (Pharmacological Research 2013; cited on PTO-892).
Regarding claims 1 and 3-10, see the discussion above.
Regarding claim 2, Löscher 1991 does not disclose that the number of animals used is no more than 11.
Löscher 2013 discloses evaluating the anti-convulsant efficacy of antiepileptic drugs such as phenobarbital, imepitoin, diazepam, and valproate using a seizure threshold model in dogs (Abstract; Table 2). Löscher 2013 discloses using 7-9 beagle dogs to determine anti-convulsant potencies (page 41, 2.4. Determination of anticonvulsant potencies).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Löscher 1991 to use no more than 11 animals to assess the anti-convulsant properties of a test compound. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Löscher 2013 teaches that anti-convulsant potencies can be determined using 7-9 animals. Further, a person of ordinary skill in the art would have been motivated to use no more than 11 animals as taught by Löscher 2013 in order to reduce animal usage during drug screening. Accordingly, applying the teaching of Löscher 2013 to the method of Löscher 1991 to use no more than 11 animals constitutes no more than the predictable use of prior art elements according to their established functions and therefore renders claim 2 obvious.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Löscher et al. (Epilepsy Res. 1991; cited on IDS filed February 28, 2024) in view of Jim et al. (Epilepsia 1989; cited on PTO-892).
Löscher 1991 is discussed above.
Löscher 1991 does not disclose the animal used is a pig.
Jim discloses examining the anti-convulsant efficacy of lorazepam for suppressing seizure activity using a seizure model in pigs (Abstract; TABLE 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Löscher 1991 to use pig to assess the anti-convulsant properties of a test compound. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Jim teaches that anti-convulsant properties can be determined using pigs. Further, a person of ordinary skill in the art would have been motivated to use pigs as taught by Jim in order to test drugs using an animal model more physiologically similar to human. Accordingly, applying the teaching of Jim to the method of Löscher 1991 to substitute pigs for the animals used in Löscher 1991 constitutes no more than the predictable use of prior art elements according to their established functions and therefore renders claim 11 obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONG HWAN BAEK whose telephone number is (571)272-0670. The examiner can normally be reached Mon - Thu, 9 am - 3 pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618