DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the claims and applicant arguments/remarks, filed 03/17/2026, is acknowledged.
Claims 15, 17-18, 22, 24-25, 28-30, 37-38 are pending in this application. Claims 2, 6-7, 11-14, 31-36 have been cancelled. Claims 1, 3-5, 8-10, 16, 19-21, 23, 26-27 have been cancelled previously. Claims 15, 18, 22, 28, 37 have been amended. Claims 15, 17-18, 22, 24-25, 28-30, 37-38 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
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 divisional of U.S. Patent Application No. 17/384,083, filed July 23, 2021 and now issued as U.S. Patent No. 11,857,512, which claims benefit of provisional U.S. Application No. 63/056,075, filed July 24, 2020, and also claims benefit of foreign priority to EP21152595.1, filed January 20, 2021.
Information Disclosure Statement
The information disclosure statement, filed 03/17/2026, is acknowledged and has been considered. Please see the attached initialed PTO-1449.
Clarification of the U.S. Patent, identified by the number "19132336 as issued on 2025-05-22”, is required, because no such patent has been found.
Claim Objections
Claim 15 is objected to because of the following informalities: Newly amended claim 15 comprises the typographic error “about 2% to about 4%” that needs to be corrected to “from about 2% to about 4%”. 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 15, 17-18, 22, 24-25, 28-30, 37-38 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.
Newly amended claim 15 recites the term "about" that 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, but teaches that the term “about” allows a variability of numerical limitation by ±10%, ±5%, ±1.0%, or ±0.5% (Para. 0044). Therefore, the metes and bounds of the claimed subject matter are not reasonably clear, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Similar is applied to claims 22, 28-29, 37. Clarification is required.
Newly amended claim 18 (dependent on claim 15) recites the limitation “the composition further comprises a diluent, a flavor, a sweetener, a glidant, a binder, and a disintegrant”. As stated previously, it is well known in the field that properties of multicomponent systems (i.e., compositions) depends on compounds included as well as on concentrations of said compounds that define the network of intermolecular interactions, and thereby physical and chemical properties of the system/composition. Therefore, the function of a particular compound may change and/or depend on conditions. The instant specification provides support to this notion by teaching that the same compound can be used as different functional agents, e.g., (i) hydroxypropyl cellulose can be used as a binder (Para. 0014) and as a disintegrant (Para. 0015); (ii) talc can be used as a glidant (Para. 0013), or as a lubricant (Para. 0017); (iii) mannitol can be used as a diluent/filler (Para. 0013). To this point, it is also noted that claiming a result (here as functionality) without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation/composition. See Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Clarification is required.
Claim 18 (dependent on claim15) further recites the limitation “the diluent and the sweetener may each be mannitol” that is unclear. To this point, it is noted that the instant specification teaches the use of mannitol as the diluent/filler. Further, no information is provided in the instant specification for the use of mannitol as a sweetener. Clarification is required.
As stated previously, claims 22 (dependent on claim 15) recites the term “low-substituted hydroxypropyl cellulose” that is unclear. This term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree. Therefore, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Similar is applied to claim 28. Clarification is required.
Newly amended claim 37 recites the limitations “diluent/filler comprises microcrystalline cellulose, mannitol, or a combination thereof”, “lubricant comprises sodium stearyl fumarate and magnesium stearate in a combined amount of about 2% to about 4% by weight” that is not reasonably clear. First, it is unclear what is defined as recited functional agents – a mixture that may include other compounds even in large amounts (i.e., comprising), OR recited compounds. Second, it is unclear if recited amounts define the presence/amounts in the claimed oral pharmaceutical composition, OR in the recited functional compositions. Clarification is required.
Claim 38 (dependent on claim 37) recites the limitation “wherein the lubricant comprises magnesium stearate and sodium stearyl fumarate”. To this point, it is noted that nearly amended claim 37 discloses the composition comprising “the lubricant comprising sodium stearyl fumarate and magnesium stearate”. Therefore, it is unclear how claim 38 narrows the scope of the claim upon which it depends. Clarification is required.
Claims 17, 24-25, 30 are rejected as being dependent on rejected independent claims 15 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 15, 17-18, 22, 24-25, 28-30, 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Cheng et al., WO 2016/145046A1 (hereinafter referred to as Cheng), in view of Leonard et al., US 2016/0361301 (cited in IDS; hereinafter referred to as Leonard), Muthusamy et al., WO 2021/061701A1 (hereinafter referred to as Muthusamy), Purohit et al., US 2020/0222310 (pub. date 07/16/2020; hereinafter referred to as Purohit); and Diez et al., WO 2011/141483A2 (hereinafter referred to as Diez).
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Cheng teaches oral pharmaceutical compositions/dosage forms (e.g., solid tablets) that include an active agent, e.g., venglustat (shown on the right), i.e., a glucosylceramide synthase (GSC) inhibitor (Wikipedia), or a pharmaceutically acceptable salt thereof such as malate (Page 4, compound V; Page 6, Lns. 8-9, 12-19; Page 34, Compound No. 2; Page 43, formula Xllb; Pages 36. Ln. 24 – Page 37, Ln. 27). Cheng teaches that said compositions/dosage forms can be in form of capsules, tablets, pills, granules, powder, etc. that can be made by compression or molding with one or more accessory ingredients, i.e., by a method wherein the active agent is mixed with carriers, excipients, diluents and/or any of (1) fillers/extenders, e.g., mannitol, microcrystalline cellulose, carboxymethylcellulose, etc.; (2) binders, e.g., polyvinylpyrrolidone/povidone, hydroxypropyl methylcellulose, carboxymethylcellulose, etc.; (3) humectants; (4) disintegrants; (5) solution retarding agents; (6) absorption accelerators; (7) wetting agents; (8) absorbents; (9) lubricants such as talc, silica, magnesium stearate, etc.; and (10) coloring agents, sweeteners, etc. (Claims 13, 17; Page 58, Lns. 1-28; Examples 2, 29 as applied to claims 15, 17-18, 22, 28, 37-38).
Chen does not teach the use of sodium stearyl fumarate/lubricant, crospovidone/disintegrant, hydroxypropyl cellulose/binder, and croscarmellose sodium (claims 15, 22, 28, 37-38).
Leonard teaches oral pharmaceutical compositions comprising venglustat (here as GCS452) or a pharmaceutically acceptable salt or prodrug thereof (Para. 0068, 0379, 0380) for treating a disease mediated by GCS (Para. 0010; 0383), wherein said compositions can be in a form of capsules or tablets coated by methods well known in the art (Para. 0644); can be prepared by conventional means (Para. 0641), and may include pharmaceutically acceptable carriers, diluents, or excipients, e.g., fillers e.g., microcrystalline cellulose; lubricants, e.g., magnesium stearate, silica, talc; binding agents, e.g., pregelatinized maize starch, polyvinylpyrrolidone/povidone, hydroxypropyl methylcellulose; disintegrants, e.g., starch, sodium starch glycolate; wetting agents, e.g., sodium lauryl sulphate; etc. (Para. 0041, 0644).
Muthusamy teaches solid oral compositions comprising a GCS inhibitor (here lucerastat), wherein said compositions can be in a form of tablets, capsules, granules, powder (Para. 00108, 00120-00122). Muthusamy also teaches a process for preparation said compositions by mixing said GCS inhibitor with pharmaceutically acceptable excipients (Para. 00106) such as (i) diluents, e.g., microcrystalline cellulose, mannitol, etc. (Para. 00107); (ii) binders, e.g., hydroxypropyl cellulose, hydroxypropyl methylcellulose, povidone (Para. 00108); (iii) disintegrates, e.g., silicon dioxide, croscarmellose sodium, crospovidone (Para. 00109); (iv) glidants, e.g., silicon dioxide/silica (Para. 0010); (v) lubricants, e.g., magnesium stearate, sodium stearyl fumarate that are used to reduce adhesion and ease the release of the product from the punch and dye (Para. 0110); (vi) sweeteners, flavoring agents, colorants, preservatives, etc. (Para. 00112, 00113, 00117, 00118). Muthusamy teaches that said constituents can be used for providing (i) better processing or handling characteristics, (ii) desired dissolution profile; and for (iii) improving stability, shelf-life, and bioavailability (Para. 0006, 0007).
Purohit teaches oral pharmaceutical compositions comprising GCS inhibitor (here eliglustat) or a pharmaceutically acceptable salt thereof, e.g., malate (Para. 0050) that can be in a form of capsules, tablets, granules, pellets, etc. that can be coated (Para. 0062, 0069-0070, 0092, 0119), and a process of preparation thereof by mixing said GCS inhibitor with pharmaceutically acceptable excipients selected from (i) diluents such as microcrystalline cellulose, mannitol; (ii) binders such as cellulose derivatives, povidone; (iii) disintegrants and super-disintegrants such as crospovidone, croscarmellose sodium, low-substituted hydroxypropyl cellulose; (iv) lubricants such as 0.5-5 wt% of magnesium stearate and sodium stearyl fumarate; (v) glidants such as silicon dioxide/silica; (vi) sweetening agents/sucralose, flavoring agents, coloring agents, etc. (Para. 0075-0084; Examples). Purohit teaches a preparation of said compositions by (a) blending the active agent with fillers/diluents; (b) mixing said blend with at least one pharmaceutically acceptable excipient specifically super-disintegrants; (c) subsequently lubricating the blend; (d) at last directly compressing the lubricated blend into granules; and (e) optionally, coating said composition (Para. 0095-0097; Examples 1-3, 16-17). Purohit also teaches to sieve ingredients (here as “sift using screen”) during the preparation process (Example 2). Purohit teaches that said constituents can be used for improving/enhancing bioavailability of orally administered GCS inhibitor (Para. 0020, 0025, 0026).
Diez teaches preparation of stable oral solid pharmaceutical compositions, e.g., tablets, comprising an active ingredient in combination with (i) diluents such as mannitol, microcrystalline cellulose, hydroxypropyl cellulose; (ii) lubricants such as sodium stearyl fumarate, magnesium stearate, talc, etc.; (iii) disintegrants, e.g., low-substituted hydroxypropyl cellulose, crospovidone, croscarmellose sodium; and also may include (iv) silica as a thickening agent (Claims 2-4; Pages 5, 6). Diez teaches a process of preparing oral solid forms/tablets by direct compression (i.e., avoiding wet granulation step, which may affect a stability of the active agent), wherein said process comprising the steps of: (a) sieving all components contained in the core tablet; (b) pre-mixing the active ingredient with part of the excipients, and, optionally, with a 1st lubricant; (c) mixing the blend obtained in step b) with the remaining excipients; (d) mixing the glidants with the blend obtained in step c); (e) mixing a 2nd lubricant with the blend obtained in step d); (f) compressing the blend obtained in step e) to form a core tablet; (Claims 13-15; Page 8). Diez teaches that said approach can be used for controlling/avoiding degradation of the active ingredient by the used excipients (e.g., by magnesium stearate) during the preparation of solid dosage forms (Pages 2, 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use/try excipient/functional agents and preparation steps as taught by Leonard, Muthusamy, Purohit, and Diez preparing compositions/tablets taught by Cheng. One would do so with expectation of beneficial results, because the cited prior art teaches that said excipient/functional agents and preparation steps can be used for providing (i) improved processing or handling characteristics, (ii) desired dissolution profile; and/or for (iii) improving/enhancing stability, shelf-life, and bioavailability of tablets. With regard to the concentrations as instantly claimed, it is noted that differences in experimental parameters such as concentration of compounds in a compositions/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations comprising the same components. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Regarding the properties of the claimed compositions, it is noted that the prior art teaches formulations comprising the same components. Therefore, it is expected that since the prior art is comprised of the same components, the same beneficial properties and effects would also be provided.
Response to Arguments
Applicant's arguments, filed 03/17/2026, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New arguments and rejections have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments. Additional examiner’s comments are set forth next.
In response to applicant’s argument that the instant specification teaches “replacement of the sucralose with additional mannitol diluent (mannitol being a slightly sweet sugar alcohol) provides sufficient palatability for chewing” (Para. 0099), it is noted that the instant specification does not teach the use of mannitol as a sweetener, but teaches that variation of the claimed functional agents can be used for controlling palatability for chewing. Therefore, clarification of claim 18 is required.
In response to applicant’s argument that the term “low-substitute hydroxypropyl cellulose” is well known in the field, it is noted that neither the claim nor the specification a definition and/or examples for the term “low substituted hydroxypropyl cellulose” (e.g., 1%, or 5%, or 10%, etc.). Therefore, one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Clarification is required.
In response to applicant’s argument that using sodium stearyl fumarate and magnesium stearate in different mixing steps allows controlling homogeneity of the mix and minimize sticking during tableting, it is noted that the instant product claims disclose products/tablets/compositions comprising compounds as instantly claimed. Further, it is noted that the patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Therefore, the examiner maintains the position 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. A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. KSR International Co. v. Teleflex Inc., 550 U.S., 398 (2007). MPEP §§ 2143 and 2143.02. Applicant is advised to clarify the claim language, scope as well as the structure of the claimed product/composition 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.
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.
Correspondence
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
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