DETAILED ACTION
Status of Application
Preliminary amendments to the claims, filed 10/27/2023, are acknowledged. Claims 1-22, 25-26 are pending in this action. Claims 23, 24 have been cancelled. Claims 4, 7-8, 14, 22 have been amended. Claims 1-22, 25-26 are currently under consideration.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
This application is a 371 of PCT/US2022/028002, filed May 6, 2022, which claims benefit of provisional U.S. Application No. 63/185,554, filed May 7, 2021.
Inventorship
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.
Specification
The lengthy specification (60 pages, exclusive of claims) has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01. The specification is objected to because of the following informalities:
The use of the trademarks/trade names has been noted in this application (e.g., Pages 4-7, 12, 16-17, 20, 25-27, 31-35, 37-38, 40-45, 54-59). Although the use of trademarks/trade names is permissible in patent applications, the proprietary nature of the trademarks/trade names should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks. The use of language such as “the product X (a descriptive name) commonly known as Y (trademark)” is not permissible since such language does not bring out the fact that the latter is a trademark. Language such as “the product X (a descriptive name) sold under the trademark Y” is permissible. MPEP §608.01(v). Further, it is noted that the trademarks/trade names are used to identify a source of goods, and not the goods themselves. The formula or characteristics of the product may change from time to time and yet it may continue to be sold under the same trademark/trade name. Thus, a trademark/trade name does not identify or describe the goods associated with the trademark/trade name. Appropriate correction is required.
The specification comprises typographic errors, e.g., “of Hypromellose”, “of Sodium Lauryl Sulfate”, “of Triethyl Citrate”, “of Talc” (e.g., Page 5) that need to be corrected to “of hypromellose”, “of sodium lauryl sulfate”, “of triethyl citrate”, “of talc”, respectively. Appropriate correction is required.
The data provided in the specification are unclear, given that the data are shown without units of measurements, e.g., “20-40% coat level” (Pages 25, 44). Appropriate correction is required.
The specification comprises acronyms without proper definition (e.g., Pages 26). The acronym should be given once in parenthesis after the first use of the full term, and then the acronym used alone thereafter if needed. Appropriate correction is required.
Information Disclosure Statement
No information disclosure statement is associated with this application/submission.
Claim Objections
Claims 2-9, 11-22, 25 are objected to because of the following informalities:
Claim 2 comprises the typographic error “claim 1 wherein” that needs to be corrected to “claim 1, wherein” (see claims 5, 6). Similar is applied to claims 3-4, 6-7, 11-13, 15-21.
Claim 2 comprises the typographic error “the lasmiditan” that needs to be corrected to “lasmiditan”. Similar is applied to claims 3, 7-8.
Claim 3 comprises the typographic error “range of about 50 to” that needs to be corrected to “range of from about 50 to”. Similar is applied to claims 12, 25.
Claim 5 the typographic error “20-40% coat level” that needs to be corrected to “20-40% of coat level”. Similar is applied to claims 6, 25.
Claim 9 comprises the typographic error “Talc… and Sodium Stearyl Fumarate” that needs to be corrected to “talc … and sodium stearyl fumarate” (see claim 7). Similar is applied to claims 11-13.
Claim 14 is objected to under 37 CFR 1.75(c) as being in improper form because (i) a multiple dependent claim should refer to other claims in the alternative only; OR (ii) a multiple dependent claim cannot depend from another multiple dependent claim (see claim 3). MPEP § 608.01 (n). The claim 14 has been further treated as dependent on independent claim 1. Similar is applied to claims 21, 22.
It is suggested that in claim 22 the limitation “a patient comprising” should be corrected to “a patient, the method comprising” for clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-22, 25-26 are 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 pre-AIA the applicant regards as the invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. MPEP § 2172.01. The omitted elements are: granulated particles of lasmiditan or a pharmaceutically acceptable salt thereof, wherein said granulated particles are coated with Kollicoat® Smartseal 30 D (see Summary in the instant specification). Clarification is required.
Claim 3 recites the limitation “lasmiditan comprises granulated particles having a size range of about 50 to about 275 microns” that is not reasonably clear. First, the limitation “lasmiditan comprises granulated particles” is unclear, because it is unclear how the chemical compound (i.e., lasmiditan) may comprise particles. This limitation was interpreted as best understood as “lasmiditan is present in a form of granulated particles”. Clarification is required. Second, it is unclear what particle size should be measured – radius, diameter. Third, it is noted that where a claimed value (i.e., particle size) varies with its method of measurement and several alternative methods of measurement are available, the value is indefinite when the claim fails to concurrently recite the method of measurement used to obtain it. Honeywell Intl. v. Intl. Trade Commn., 341 F.3d 1332, 1340 (Fed. Cir. 2003). It is well known in the field that there is no a comprehensive standard for particle size measurements, and different methods of particle size analysis yield different estimates of particle size for the same sample (see Wikipedia and references cited wherein; “Interpretation of Particle Size Reported by Different Analytical Techniques” on labmanager.com; “Comparison of particle characterization methods” on microtrac.com), i.e., experimental estimates of particle sizes depend on methods of measurements used to obtain it. Without knowing these parameters, the metes and bounds of the claimed subject matter cannot be determined. Similar is applied to claim 8. Clarification is required.
Claim 4 contains the trademark/trade name Kollicoat® Smartseal 30D. To this point, it is noted that where a trademark/trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112, second paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark/ trade name cannot be used properly to identify any particular material or product. A trademark/trade name is used to identify a source of goods, and not the goods themselves. The formula or characteristics of the product may change from time to time and yet it may continue to be sold under the same trademark/trade name. Thus, a trademark/trade name does not identify or describe the goods associated with the trademark/trade name. In the present case, the trademark/trade name is used to identify/describe the reverse enteric coating and, accordingly, the identification/description is indefinite. Similar is applied to claims 5-9, 12-13. Clarification is required.
Claim 7 recites the limitation “lasmiditan to be coated with Kollicoat® Smartseal 30 D further comprises talc” that is unclear. In the present case, it is unclear how the chemical compound (i.e., lasmiditan) can be coated and/or may comprise another chemical compound (i.e., talc). Similar is applied to claim 8. Clarification is required.
Claim 8 recites the limitation “size range between about 75 and about 300 microns”, that is not reasonably clear. First, it is notes that the term “between” means that the size cannot be 75 microns or 300 microns, however, by using the term "about" the claim does allow the size to be 75 microns or 300 microns. Therefore, the metes and bounds of the claim cannot be determined. Second, it is noted that the term "about” is a relative term, which renders the claim indefinite. This term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Similar is applied to claims 12-20. Clarification is required.
Claim 12 recites the limitation “3.9% to 4.9% w/w of aspartame/Cherry berry flavoring blend (Aspartame about 68% to Cherry Berry Flavor about 32% w/w)” that is not reasonably clear. In the present case, it is noted that said claim comprises parenthetical expression that does not clarify the scope of the claim. To this point, it is noted that parenthetical expressions are not permissible, which do not contribute to clearness or exactness in stating applicant’s invention. Ex parte Cahill, 1893 C. D., 78; 63 O. G., 2125. Similar is applied to claim 13. Clarification is required.
Claim 21 recites the limitation “the composition further comprises an orally disintegrating tablet” that is unclear. In the present case, it is noted that the instant specification discloses tablets comprising coated particles of lasmiditan (see claim 26). Clarification is required.
Claim 25 recites the limitation “coating over the particles comprising a reverse enteric polymer in an amount of 20% to 40% coat level” that is not reasonably clear. In the present case, it is unclear if said polymer should be in particles, OR in the coating. Clarification is required.
Claims 2, 10-11, 22, 26 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
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.
Claims 1-2, 14-22 are rejected under 35 U.S.C. 103 as being unpatentable over Yuan et al., US 2021/0299081-A1 (hereinafter referred to as Yuan), Halse et al., US 2014/0235556-A1 (hereinafter referred to as Halse), and Hansen et al., US 2013/0252965-A1 (hereinafter referred to as Hansen).
Yuan teaches solid formulations for oral administering (Title), wherein said formulations can be in a form of tablets (Para. 0061, 0093, 0116); may include disintegrants, and can be enterically coated with coating polymethacrylates, e.g., Eudragit L, Eudragit S, Eudragit FS, Kollicoat MAE 30 DP, Kolllicoat MAE 100P, Eudragit RL, Eudragit RS, Eudragit NE 30D, Eudragit NE 40D, Eudragit NM30D (Para. 0087; Tables 10, 11). Yuan teaches that said compositions/tablets may include anti-migraine drug, e.g., lasmiditan (Para. 01386, 0137, 0143), and can be used for treating a migraine (Para.0178).
Halse teaches pharmaceutical compositions that may include lasmiditan or a pharmaceutically acceptable salt thereof, wherein said compositions can be in a form of compressed tablets and may include enteric coatings (Claim 31; Para. 0052, 0057, 0070-0071 as applied to claim 1). Halse teaches that suitable dosages of said active agent can be in the range of from 1 mg/kg to 2400 mg/kg (Para. 0064 as applied to claims 14-20).
Hansen teaches pharmaceutical compositions/tablets coated with enteric coating that may include 5-HT1F receptor agonist, e.g., lasmiditan (Para. 0101, 0108-0109, 0189), wherein said compositions/tablets can be administered orally to a patient in need thereof in doses of from 0.5 mg/day to 200 mg/day (Para. 0122-0128, 0180).
Therefore, it is the examiner’s positions that the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made/filed, because every element of the invention has been collectively taught by the combined teachings of the references.
To expedite the prosecution, it is noted that the prior art does not teach or suggest compressed oral dispersible tablets comprising granulated particles of lasmiditan or pharmaceutically acceptable salt thereof and having particle diameter of 50-275 microns, wherein said particles are coated with a specific entering coating (i.e., Kollicoat® Smartseal 30 D), and wherein said tablets also include additional constituents as instantly claimed (see claims 12, 13). Applicant teaches that said approach allows suppressing dissolution of lasmiditan in saliva, and provide a rapid release of said drug in the gastrointestinal tract GI. Applicant is advised to clarify the claim language, the structure of the claimed product, and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615