DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission, filed 06/18/2026, has been entered.
Status of Application
Receipt of the amendments to the claims and applicant arguments/remarks, filed 06/18/2026, is acknowledged.
Claims 1-2, 5, 7, 9, 11, 13, 15-21 are pending in this action. Claims 4, 6, 8, 10 have been cancelled. Claims 3, 12, 14 have been cancelled previously. Claims 1, 2, 5,7, 9, 11 have been amended. Claims 1-2, 5, 7, 9, 11, 13, 15-21 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Any rejection or objection not reiterated in this action is withdrawn.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 371 of PCT/MX2020/050050, filed December 4, 2020.
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, 5, 7, 9, 11, 13, 15-21 are rejected under 35 U.S.C. 103 as being unpatentable over Pattaro Marcondes et al., WO 2020/044070 (cited in IDS; filing date 08/20/2018; hereinafter referred to as Pattaro Marcondes), in view of Darmuzey et al., US 2008/0311162A1 (hereinafter referred to as Darmuzey), Pilgaonkar et al., US 2013/0078290 A1 (hereinafter referred to as Pilgaonkar), and Patel et al., US 2003/0215496 A1 (hereinafter referred to as Patel).
Pattaro Marcondes teaches synergistic pharmaceutical compositions for treating neuropathic pain associated with central and peripheral neuropathic pain, wherein said compositions can be in a solid form as tablets, capsules, granules, and wherein said composition may include 25-100 mg of tramadol or salt thereof and 40-250 mg of pregabalin or salt thereof (Claims 8, 9, 19; Abstract; Page 7, Ln. 8- Page 8, Ln. 22 as applied to claims 1-2, 15-21). To this point, Pattaro Marcondes teaches that said compositions may further include such excipients as: (i) microcrystalline cellulose, pregelatinized starch, corn starch (identified in the instant application as diluents); (ii) hydroxypropyl cellulose, carboxymethylcellulose, crospovidone, croscarmellose (identified in the instant application as disintegrants); (iii) magnesium stearate, talc (identified in the instant application as lubricants); (iv) colloidal silicon dioxide (identified in the instant application as absorbent; Page 9, Lns. 4-17).
Pattaro Marcondes does not teach that said compositions comprise magnesium aluminum silicate and are coated (claim 1).
Darmuzey teaches solid compositions that may include tramadol and/or pregabalin or pharmaceutically or nutraceuticaly acceptable salts thereof (Claim 19; Abstract; Para. 0065), wherein said compositions may include: microcrystalline cellulose, magnesium aluminum silicate, magnesium carbonate, magnesium oxide, pregelatinized starch, hydroxypropyl cellulose, carboxymethylcellulose, crospovidone, talc, colloidal silicon dioxide, xylitol, lactitol, mannitol, kaolin, (Claim 8; Para. 0062). Darmuzey further teaches that said composition can be coated with sustained release coating, enteric coating, taste-masking coating, moisture barrier coating, pressure sensitive barrier coating, pressure insensitive barrier coating and oxygen barrier coating and combinations thereof, wherein said coating formulations may include hydroxypropyl methylcellulose, hydroxypropyl cellulose, carboxymethylcellulose, polyvinyl alcohol, polyethylene glycol, polyvinylpyrrolidone/povidones (Claim 24; Para. 0069).
Pilgaonkar teaches dosage forms/tablets that provide controlled release, gastric residence time, and desired bioavailability of the drug (Para. 0010), wherein said dosage forms may include gabapentin or salt thereof (Para. 0015) in combination with tramadol (Para. 0054), and also may also include: microcrystalline cellulose, magnesium aluminum silicate, cross-linked sodium carboxymethyl cellulose/croscarmellose (Para. 0037), magnesium stearate/lubricant (Para. 0041). Pilgaonkar further teaches that said dosage forms can be coated with a coating comprising hydroxypropyl methylcellulose, hydroxypropyl cellulose, carboxymethyl cellulose, polyvinyl alcohol (Para. 0046).
Patel teaches solid pharmaceutical compositions, e.g., tablets or capsules, for improved delivery of pharmaceutical active ingredients contained therein, e.g., gabapentin and/or tramadol or pharmaceutically acceptable salts thereof (Title; Abstract; Para. 0036-0039, 0116), wherein said compositions may include microcrystalline cellulose (Para. 0116, 0155-0156, 0165), croscarmellose sodium (Para. 0156) magnesium stearate (Para. 0144, 0155), magnesium aluminum silicate (Para. 0149), and wherein said solid dosage forma can be coated (Para. 0019, 0030) with coatings that may include hydroxypropyl cellulose, carboxymethyl cellulose (Para. 0167-0172), polyethylene glycol (Para. 0189).
Therefore, it is the examiner’s 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. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply coatings as taught by Darmuzey, Pilgaonkar and Paten to solid compositions as taught by Pattaro Marcondes, because it is prima facie obvious to combine compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a new composition to be used for the very same purpose. MPEP 2144.06. One would do so with expectation of beneficial results, because the cited prior art teaches that said approach/coatings can be used for (i) providing desired/controlled drug release rate, gastric residence time and desired bioavailability of the drugs; (ii) for protection from moisture or oxygen; and also (iii) allows controlling/minimizing the effect of pressure (e.g., used in preparation of solid compositions) on the intendent release profile.
With regard to the concentrations of excipients as instantly claimed, it is noted that differences in experimental parameters such as concentration of compounds in a composition/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 compositions 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 disclosed coating system (i.e., a light protective coating), it is noted that the cited prior art teaches compositions that are substantially the same as the compositions recited by the instant claims, i.e., comprise components as instantly claimed. 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 06/18/2026, have been fully considered, but they are moot in view of amendments to the claims. Applicant's amendments necessitated new ground(s) of rejection presented in this office action. New rejections and arguments have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments. Applicant is advised to clarify the structure of the claimed compositions 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 conditions 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.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
Prosecution Insights