DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the specification and claims as well as applicant arguments/remarks, filed 12/09/2025, is acknowledged. Amendments to the specification have been entered.
Claims 1-2, 4-11, 13, 15-21 are pending in this action. Claims 3, 12, 14 have been cancelled. Claims 1-2, 4-6, 8, 10, 13, 15-18 have been amended. Claims 1-2, 4-11, 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Any rejection or objection not reiterated in this action is withdrawn.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 Objections
Claims 1-2, 4, 6, 8, 10 are objected to because of the following informalities:
Newly amended claim 1 recites the limitation “in an amount of from 50-150 mg (inclusive of the boundary limits)” that needs to be corrected to “in an amount of from 50 mg to 150 mg” for clarity. Similar is applied to claim 2.
Newly amended claim 2 comprises the typographic error “the pregabalin” that needs to be corrected to “pregabalin”.
Newly amended claim 4 recites the limitation “the pharmaceutically acceptable excipient is the diluent and is selected from the group consisting of microcrystalline cellulose, dibasic calcium phosphate, pregelatinized starch, corn starch, mannitol, xylitol, maltitol, lactitol, sorbitol, and sucrose, or a combination thereof” that needs to be corrected to “the pharmaceutically acceptable excipient is the diluent selected from the group consisting of microcrystalline cellulose, dibasic calcium phosphate, pregelatinized starch, corn starch, mannitol, xylitol, maltitol, lactitol, sorbitol, sucrose, and a combination thereof”. Similar is applied to claims 6, 8, 10.
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 4-7, 10-11 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.
As stated previously, claims 4, 6, and 10 are unclear, because different functional agents, i.e., a diluent (Claim 4), a disintegrant (Claim 6), and an absorbent (Claim 10) identified by the same chemical compound, i.e., microcrystalline cellulose (claims 4, 6, 10); “corn starch”, “pregelatinized starch” (claims 4, 6). Therefore, one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Clarification is required.
Claims 5, 7, 11 are rejected as being dependent on rejected claims 4, 6, 10 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, 4-11, 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).
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 claim 1-2, 14-21). 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 as applied to claims 4, 6, 8, 10).
Pattaro Marcondes does not teach that said compositions are coated (claim 1).
Darmuzey teaches solid compositions that may include tramadol and/or pregabalin (Claim 19; Abstract; Para. 0065), wherein said compositions may include: microcrystalline cellulose, pregelatinized starch, hydroxypropyl cellulose, carboxymethylcellulose, crospovidone, talc, colloidal silicon dioxide, xylitol, lactitol, mannitol, kaolin, magnesium aluminum silicate, magnesium carbonate (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).
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 to solid compositions as taught by Pattaro Marcondes. One would do so with expectation of beneficial results, because Darmuzey teaches that said approach can be used for providing desired/controlled drug release rate, for protection from moisture or oxygen, as well as 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 12/09/2025, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New objections, rejections and arguments 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 arguments against the references individually, it is noted that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). Further, it has been held that a prior art reference must either be in the field of applicant’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the applicant was concerned, in order to be relied upon as a basis for rejection of the claimed invention. In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992).
In the present case, all cited references are reasonably drawn to the same field of endeavor that is oral solid dosage units (e.g., tablets, capsules, etc.) comprising tramadol and pregabalin together with pharmaceutically acceptable excipients. Further, it is noted that the cited prior teaches that compositions comprising said active agents may include: (i) excipients as instantly claimed (Pattaro Marcondes, Darmuzey); and (ii) a coating comprising compounds as instantly claimed (Darmuzey). 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. To this point, it is noted that the Supreme Court decided (KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007)) that:
(i) the obviousness analysis needs not seek out precise teachings directed to the subject matter of the challenged claim and can take into account the inferences and creative steps that one of ordinary skill in the art would employ;
(ii) the obviousness analysis cannot be confined by a formalistic conception of the words teaching, suggestion and motivation, or by overemphasis on the importance of published articles and the explicit content of issued patents;
(iii) it is error to look only the problem the patentee was trying to solve. Any need or problem known in the field of endeavor at the time of invention and addressed by the prior art can provide a reason for combining the elements in the manner claimed;
(iv) it is error to assume that one of ordinary skill in the art in attempting to solve a problem will be led only to those elements of prior art designed to solve the same problem. Common sense teaches that familiar items may have obvious uses beyond their primary purposes, and in many cases one of ordinary skill in the art will be able to fit the teachings of multiple patents together like pieces of a puzzle (one of ordinary skill in the art is not automaton);
(v) it is error to assume that a patent claim cannot be proved obvious merely by showing that the combination of elements was “obvious to try”.
Regarding the properties of the disclosed compositions (i.e., stability/stable; light-protective coating), it is noted that the cited prior art teaches formulations/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. 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). 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.
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.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615