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 11/13/2025, is acknowledged. No amendments to the specification and/or drawings have been entered.
Claims 1-3, 5-7, 24-28, 30-34, 47-49 are pending in this action. Claim 4 has been cancelled. Claims 8-23, 29, 35-46, 50-51 have been cancelled previously. Claims 1-3, 5-7, 24-28, 30 and 47-48 have been amended. Claims 1-3, 5-7, 24-28, 30-34, 47-49 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Any rejection or objection not reiterated in this action is withdrawn.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 claims benefit of provisional U.S. Application No. 63/344,521, filed May 20, 2022.
Specification
The specification is objected to because of the following informalities:
As stated previously, the specification comprises references on publications (e.g., Page 1). To this point, it is noted that the incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g). Further, as stated previously, the reference “USP, Metaxalone Tablets” (recited on Pages 2, 3, 7) is not clear. To this point, it is noted that the publications recited in the instant application should be identified by publisher, author (if any), title, relevant pages of the publication, date, and place of publication. MPEP 609.05(a). Appropriate correction is required.
The specification comprises multiple acronyms without proper definition, e.g., “FGM”, “SGM” (e.g., Page 2). 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.
Drawings
As stated previously, the drawings, filed 05/16/2023 and/or 06/01/2025, are objected to because in Figs. 1 and/or 5 x-axis and/or y-axis are not identified. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 5, 6, 24 are objected to because of the following informalities: Newly amended claim 5 comprises the typographic errors “a first grade of metaxalone or a pharmaceutically acceptable salt thereof (the first FGM quantity)” that need to be corrected to “a first grade of metaxalone or a pharmaceutically acceptable salt thereof (a first FGM quantity)” or clarified. Similar is applied to other constituents recited in claim 5, as well as to claims 6, 24. 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 1-3, 5-7, 24-28, 30-34 and 47-49 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 1 recites the limitation “means for maintaining a stable dissolution profile” that is unclear and indefinite. To this point, it is noted that neither the claims nor the instant specification provides a definition for this term, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Does this term imply the use of specific compounds, OR specific preparation steps? Similar is applied to claims 3, 24, 47. Clarification is required.
Claim 1 attempt to encompass immediate release metaxalone tablets of metaxalone and a pharmaceutically acceptable excipient(s) that maintain a stable dissolution profile over 6 months or more, but it does so without including any materials that cause said result. As stated previously, it is well known in the field that properties of multicomponent systems (i.e., tablets) depend on compounds included as well as on concentrations and/or distributions of said compounds that define the network of intermolecular interactions, and thereby physical and chemical properties of the system/composition/tablet. The claim attempts to define the subject-matter in terms of the result to be achieved, which merely amounts to a statement of the underlying problem, without providing the technical features necessary for achieving this result. Claiming a result 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. Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Further, it is noted that “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008). Similar is applied to claims 2, 24-26, 47-49. Clarification is required.
As stated previously, claim 1 recites the limitation “under the dissolution testing described in USP, Metaxalone Tablets” that is unclear and indefinite, because neither the claims nor the instant specification describes the conditions to measure the dissolution profile. Similar is applied to claims 7, 33, 47. Clarification is required.
Claims 5-6, 27-28, 30-32, 34 are rejected as being dependent on rejected independent claims 1 and 24 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 1-3, 5-7, 24-28, 30-34 and 47-49 are rejected under 35 U.S.C. 103 as being unpatentable over Gande et al., US 2020/0405693A1 (pub date 12/31/2020, hereinafter referred to as Gande).
Gande teaches compressed tablets comprising 640 mg of metaxalone, wherein said tablets release up to 65 wt% of metaxalone at 90 minutes when tested in 900 mL of a pH 6.0 phosphate buffer dissolution medium (Para. 0007, 0053 as applied to claims 1, 24, 47). Gande further teaches that said tablets may include: (a) 40-80 wt% micronized particles of metaxalone, wherein 90% of the micronized particles of metaxalone are smaller than 500, or 350, or 200, or 100, or 75, or 50 microns as tested according to the Malvern Method; and (b) 20-60 wt % non-micronized particles of metaxalone, wherein less than 10%, or 5%, or 2% of the non-micronized particles are retained on a #30 sieve (i.e., 600 micron), and at least 25%, 35%, or 45% of the non-micronized particles of metaxalone are retained on a #120 sieve (i.e., 125 micron) when tested by the Sieve Method (Para. 0008 as applied to claims 31, 32).
Gande teaches that said compressed tablets may also include such pharmaceutically acceptable excipients as 10-30 wt% of propylene glycol alginate, 20-35 wt% of lactose monohydrate; 10-30 wt% of alginic acid; 40-60 wt% of povidone; and 2-8 wt% of magnesium stearate (Para. 0009, 0043; Examples as applied to claims 1, 30, 47).
Therefore, it is the examiner’s positions that the claimed invention (i.e., metaxalone tablets), 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 taught by the teachings of the reference cited.
Regarding product-by-process claims 5, 7, it is noted that product-by-process claims do not carry any patentable weight unless there is factual evidence to the contrary. MPEP 2113. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. 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). As a practical matter, the Patent Office is not equipped to manufacture products by the myriad number of processes put before it and then obtain prior art products and make physical comparisons therewith. In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the applicants.
Regarding the properties of the disclosed tablets, it is noted that the cited prior art teaches tablets that are substantially the same as the tablets recited by the instant claims and/or described/exemplified in the instant specification (see Page 20 in the instant specification). 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. Further, it is noted that it is well known in the field that controlling the hardness of pharmaceutical compositions/tablets can be used for providing/improving a bioavailability of the active compound included in said compositions/tablets. The pertinent prior art of record provides the support to the examiner’s positions. Furthermore, it is noted that the fact that applicant has recognized another advantage, which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20060167069 A1 - teaches tablet comprising 400-1600 mg of metaxalone micronized to the desired particle size range (Para. 0011-0016), wherein said tablets may also include polyvinyl pyrrolidone, magnesium stearate, and other pharmaceutically acceptable excipients (Para. 0018), and further teaches that bioavailability of said active compound can be controlled by hardness of tablets (Para. 0020).
Response to Arguments
Applicant's arguments, filed 11/13/2025, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New arguments and/or 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 the applicant’s argument that compositions disclosed by Gande do not have the same properties as similar compositions prepared by the applicant (Example 5), it is noted that it is well known in the field that properties of multicomponent systems (i.e., tablets) depend on compounds included as well as on concentrations and/or distributions of said compounds that define the network of intermolecular interactions, and thereby physical and chemical properties of the system/composition/tablet. As best understood, the applicant discloses the preparation of tablets by using two types of metaxalone particles having specific particle size, wherein the mean particle size of the first FGM is 1-60 microns and the mean particle size of the first SGM is 100-1000 microns as measured by laser light diffraction (Specification, Para. 0038-0041, 0063; Fig. 1); and wherein said particles are present at a specific ratio (Para. 0043, 0046). Therefore, it is the examiner’s position that a feature that is taught as critical in the specification should be recited in the claims (see MPEP § 2172.01). Applicant is advised to clarify the claim language, the structure of the claimed tablets as prepared by a specific method 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 reference 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. 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615