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 .1
Status of Claims
Claims 1-20 are pending and under Examination.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16/624,381 filed on 12/19/201.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 27, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections and Claim Interpretation
Claims 8 and 15 are objected to because of the following informalities: at claim 8, line 2, and claim 15, line 3, both claims recite “the same AMPA receptor site.” As this is the first instance of the term “same AMPA receptor site,” it should be prefaced with “a” rather than “the.” Appropriate correction is required. Note claims 8 and 15, and claims dependent, are rejected for lack written description as detailed below.
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 8-20 are 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 8 and 15 drawn to compounds merely described by the functionally descriptive language “an AMPA receptor inhibitor that binds to the same AMPA receptor site as perampanel” or a variation thereof. Dependent claims 9-14 and 16-20 are similarly rejected as they do not further describe or identify any AMPA receptor inhibitor that acts as the same site as perampanel.
The functionally descriptive language has support in the specification at paragraphs 108-114, Section entitled “AMPA receptor inhibitor that binds to the same AMP A receptor site as perampanel.”
This section of the specification merely describes these AMPA receptor inhibitors by various known methods that have
1) been suggested to bind to S1-M1 and S2-M4 linker domains GluA2 of the AMPA receptor (per Yelshanskaya et al.). See paragraph 110;
2) modeled by whole cell-patch clamp methods in Xenopus oocytes (referencing Chang et al.), at particular IC50 values of inhibition, see paragraphs 111-113.
The specification generically states AMPA receptor inhibitors that act at the same site as perampanel are small molecules, polypeptides or proteins. It only defines perampanel as an AMPA receptor inhibitor that works at the same site as perampanel. See paragraph 114.
Per MPEP 2163 and relevant case law, to provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of the complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
In this case, the only factor present is that disclosure of the functional descriptive language that such AMPA receptor inhibitors act at the same site as perampanel (i.e. perampanel) and can be small molecules, peptides and proteins. See paragraph 114.
Whether perampanel in of itself binds to a perampanel binding site is not the issue, the claims are drawn to any AMPA receptor inhibitor capable of binding to a perampanel capable binding site. Applicant provides no guidance other than the broad description of small molecules, proteins and peptides and reference to particular binding tests directed to methods of perampanel binding to AMPA receptor sites so as to inhibit the receptor.
In University of Rochester v. G.D. Searle & Co., 68 USPQ2d 1424 (DC WNY 2003), at issue was a patent directed to method for inhibiting prostaglandin (PGHS-2) synthesis in a patient using an unspecified compound. The District Court of Western New York evaluated the level of disclosure required to satisfy the written description. In their decision (which was later affirmed by the CAFC), the District Court wrote, "The real issue here is simply whether a written description of a claimed method of treatment is adequate where a compound that is necessary to practice that method is described only in terms of its function, and where the only means provided for finding such a compound is essentially a trial-and-error process."
The patent in Rochester does no more than describe the desired function of the compound called for, and it contains no information by which a person of ordinary skill in the art would understand that the inventors possessed the claimed invention. At best, it simply indicates that one should run tests on a wide spectrum of compounds in the hope that at least one of them will work. The specification of the patent in Rochester states that the invention comprises, inter alia, "assays for screening compounds, including peptides, polynucleotides, and small organic molecules to identify those that inhibit the expression or activity of the PGHS-2 gene product; and methods of treating diseases characterized by aberrant PGHS-2 activity using such compounds." Nowhere, however, does it specify which "peptides, polynucleotides, and small organic molecules" have the desired characteristic of selectively inhibiting PGHS-2.2
The "written description" requirement may be satisfied by using such descriptive means as words, structures, figures, diagrams, formulas, etc., that fully set forth the claimed invention. See Noelle v. Lederman, 355 F.3d 1343, 1349, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) and Lockwood v. American Airlines, Inc., 107 F.3d at 1572, 41 USPQ2d at 1966. A definition by function alone "does not suffice" to sufficiently describe a coding sequence "because it is only an indication of what the gene does, rather than what it is." Regents of the University of California v. Eli Lilly & Co., 119 F.3 at 1568, 43 USPQ2d at 1406 (Fed. Cir. 1997) (discussing Amgen Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991 )). In Fiefs v. Ravel, 984 F.2d at 1169-71,25 USPQ2d at 1605-06 (1993), the CAFC found that "a mere wish or plan for obtaining the claimed chemical invention" is not sufficient to describe a chemical invention (discussed in Eli Lilly at 1404).
The fact pattern in this case is similar to that in Rochester. In Rochester, there were no compounds known to have the required function, and in the instant application, the only AMPA receptor inhibitor with the claimed functional descriptive language taught is perampanel, which has the capability to bind to a perampanel (i.e. same) site.
The key similarity between the cases, and the one relevant to this ground of rejection, is the fact that no method (other than trial-and-error) is provided for identifying compounds having the desired function. For this reason, the rejection due to lack of written description is proper
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.
Claim 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. BRAIN 2016: 139; 431–443.
Chang is cited on the IDS dated June 27, 2024 as NPL reference 1.
By way of background, the claimed invention’s specification notes that medium chain triglyceride (MCT) diets have long been recognized as treatment for epilepsy, since 1971, see page 1 of Specification. As noted by the specification, the cited prior art Chang, has identified the MCT, decanoic acid, as an inhibitor of AMPA receptors, see page 2 of the specification. Perampanel, is a known AMPA receptor antagonist indicated for related seizure and epileptic disorders, see page 2 of the Specification.
Claim 1 is directed to a method for treating epilepsy, the method comprising administering perampanel or a pharmaceutically acceptable salt thereof to a patient in need thereof, wherein the perampanel or pharmaceutically acceptable salt thereof is used in combination with decanoic acid.
Claims 3, 10 and 16 identify the subject patient is responsive to AMPA receptor inhibition. Claims 8 and 15 are also directed to treatment of epilepsy, where both perampanel and decanoic acid bind to the same AMPA receptor site.
Regarding claims 1, 3, 8, 10 and 15-16 Chang teaches that decanoic acid controls seizures and treats epilepsy via direct AMPA receptor inhibition, see title and abstract. Chang teaches perampanel acts to treat seizures and drug-resistant epilepsy, see page 439, second column, last paragraph. Chang teaches act upon the SAME AMPA receptor, where decanoic acid may exhibit a different physiological effect to perampanel, Id.
Chang teaches as perampanel and decanoic acid act at separate sites, it is possible that they have a cooperative effect at the AMPA receptor, suggesting that perampanel and the ketogenic diet (via decanoic acid) could be synergistic, see page 441, column 2, last paragraph. See also Figure 7 A and B, noting decanoic acid and perampanel binding sites on M3 helix AMPA receptor model (active protein configuration (3KG2) of GluA2).
It is noted that Chang does not teach a clinical subject patient treated with both decanoic acid and perampanel but rather just notes decanoic acid and perampanel upon AMPA receptor separate sites and suggests synergistic activity between the two. Despite this, Chang teaches and suggests a combination of treatment in a subject with the both drugs as detailed above.
Regarding claims 8 and 15 and binding to a same AMPA receptor site as perampanel by an AMPA receptor inhibitor, Chang teaches binding of perampanel to its AMPA receptor inhibitor site. See above.
Prior to the filing of the present patent application, it would have been prima facie obvious to a person having ordinary skill in the art (PHOSITA) following the teachings of Chang to combine both decanoic acid and perampanel to treat a subject, as both are noted to have anti-convulsant activity via inhibition of the same site, the AMPA receptor.
Per MPEP 2143 (a) the rationale to support a finding of obviousness is combination of prior art elements according to known methods (the elements being the teaching of Chang that perampanel and decanoic acid may act synergistically upon the same AMPA receptor according to the known method of treating epilepsy with them) to predictably arrive at the claimed invention, therefore providing a PHOSITA with a reasonable expectation of success.
Further, as required by claims 8 and 15, Chang teaches the AMPA receptor inhibitor, perampanel binding to a site on the AMPA receptor, thus meeting the limitation of binding of an inhibitor (perampanel) binding to the same perampanel binding AMPA receptor site.
Regarding claims 2 and 9 and the limitation of either separate or sequential administration of perampanel and decanoic acid, Chang teaches and suggests co-administration of perampanel and decanoic acid, see page 441, column 2, last paragraph, where such co-administration, by virtue of the definition of co-administration, can occur separately or in a sequence optimized by one of ordinary skill in the art, via the teaching by Chang, where the cooperative effect at the AMPA receptor of the two, could be synergistic.
Regarding claims 4, 11 and 17, Chang teaches a medium chain triglyceride (MCT) diet is an established treatment of drug-resistant epilepsy, that increases plasma levels of decanoic acid. See abstract. Chang teaches that subjects who cannot comply with a MCT diet, better tolerate a normal diet with just added decanoic acid, e.g. in the form of a triglyceride, see page 441, 2nd column, last paragraph.
Regarding claims 5-6, 12-13 and 18-19, it would be obvious to formulate and administer a food-stuff (medical food, nutritional composition/supplement) comprising decanoic acid and perampanel, Chang teaches use of decanoic acid fed to subjects for its effect on seizure control, see page 442, first column. More specifically, Chang teaches that dietary MCT oils (where it is known that decanoic acid is a medium chain triglyceride (MCT)), concomitant with a non-restricted carbohydrate diet, Id. Additionally, Chang teaches decanoic acid is a major constituent of the MCT ketogenic diet, thus suggesting decanoic acid as a food stuff, see page 440, column 1, last paragraph.
Regarding claims 7, 14 and 20, Chang teaches perampanel is a known treatment for partial onset seizures with efficacy in otherwise drug-resistant epilepsy (citing to Russo 2012 and Rektor 2013), where such perampanel treatment must be known in the art to occur via a pharmaceutical composition comprising one or more acceptable carriers, diluents and/or excipients. See page 439 column 2. It would be obvious to a PHOSITA to treat epileptic subjects with a pharmaceutical composition comprising perampanel (as per Chang citing Russo and Rektor and what is generally known in the art, drug compounds administered to patients are in the form of pharmaceutical compositions comprising excipients/carriers), where such composition would further comprising decanoic acid, as taught by Chang as detailed above. Also note References section of Chang with numerous citations to articles referencing drug treatments that obviously require pharmaceutical compositions to treat epilepsy. For example see Meldrum et al. Molecular targets for antiepileptic drug development. Neurotherapeutics 2007; 4: 18–61, cited on page 443, column 1 of the References section.
Further, regarding the limitation of claims 7, 14 and 20, the limitation of acceptable carriers, the various teachings of Chang above, the use of decanoic acid as a food stuff or as component of an MCT ketogenic diet, suggest decanoic acid in a composition further comprising a carrier, diluent or excipients.
Conclusion and Correspondence
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
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/WILLIAM Y LEE/Examiner, Art Unit 1623
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
1 CONTINUING DATA This application is a CON of 16/624,381 12/19/2019 ABN
16/624,381 is a 371 of PCT/EP2018/067355 06/28/2018
FOREIGN APPLICATIONS
EP 17178751.8 06/29/2017
2 The Rochester court cited the CAFC in Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 1316 (63 USPQ2d 1609), which adopted the standard set forth in the Patent and Trademark Office ("PTO") Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, 1 "Written Description" Requirement ("Guidelines"), 66 Fed. Reg. 1099 (Jan. 5, 2001 ), which state that the written description requirement can be met by "showing that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics," including, inter alia, "functional characteristics when coupled with a known or disclosed correlation between function and structure ...." Enzo, 296 F.3d at 1324-25 (quoting Guidelines, 66 Fed. Reg. at 1106 (emphasis added)).
The Rochester court also cited the CAFC in Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 [43 USPQ2d 1398] (Fed. Cir. 1997), in which the court drew a distinction between genetic material and other chemicals; in drawing this distinction, however, the court also stated that "[i]n claims involving [non- genetic] chemical materials, generic formulae usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate description of the claimed genus." 119 F.3d at 1568 (emphasis added). There is no such specificity here, nor could one skilled in the art identify any particular enzymatic effector encompassed by the claims.
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