Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 on 3/2/2026 has been entered.
Status of Claims
Claims 1-6, 15, 25, 28, 30, 34-35, and 37 are pending. Claim 37 remains withdrawn. Applicant previously cancelled claims 14, 16-24, 26-27, 31-33, and 36. Applicant newly cancelled claims 7-13, and 29. Applicant amended claims 1, 15, 25, 28, 30, 34 and 35.
Claims 1-6, 15, 25, 28, 30, and 34-35 are under consideration in the instant office action.
Claim Rejections - 35 USC § 112
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.
Claim 1-6, 15, 25, 28, 30, and 34-35 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Specifically, independent claim 1 has been amended to recite that the “…at least one additional pharmaceutical ingredient is dextromethorphan hydrobromide…”. Additionally, claim 1 has been amended to include “wherein the first tablet is an immediate release tablet which comprises naproxen, and the second tablet comprises an immediate release portion comprising guaifenesin and dextromethorphan and a sustained release portion comprising guaifenesin and dextromethorphan” at the last two lines of the amended claim. This has introduced inconsistency within claim 1 because the claim language has been amended to refer to dextromethorphan and its HBr salt earlier in the claims. This creates ambiguity whether the last two lines of amended claim 1 are referencing different "populations" of dextromethorphan that are present in the first and second tablets in addition to dextromethorphan HBr or whether the intent was to reference solely to dextromethorphan HBr at the added last two lines of amended independent claim 1.
The dependent claims fail to cure the deficiencies noted above and are thus rejected under similar rationale.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS. —Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 28 and 34-35 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The recitation of “Dextromethorphan or a pharmaceutically acceptable salt thereof” in dependent claims 28 and 34-35 appear to expand the scope of the recited "additional pharmaceutical ingredient" of independent claim 1 by reciting "dextromethorphan or a pharmaceutically acceptable salt thereof". This fails to further limit at least one aspect of independent claim 1 and thereby creating 112(d) issues for these dependent claims.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Modified Rejection
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Applicant Claims
2. Determining the scope and contents of the prior art.
3. Ascertaining the differences between the prior art and the claims at issue, and resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-6, 11-13, 15, 25, 28, 30, 34, and 35 are rejected under 35 U.S.C. 103(a) as being unpatentable over Davis et al. (“Davis”, US PG-PUB 2003/0049318) in view of Kim et al. (“Kim”, WO 2013/055177, cited by Applicant in the IDS filed June 15, 2023; Citations are to the US PG-PUB publication of the national phase of this PCT application: US PG-PUB 2014/0227356) and Sliva et al. ("Guaifenesin enhances the analgesic potency of ibuprofen, nimesulide and celecoxib in mice," Neuroendocrinology Letters, vol. 30, No. 3, 2009, pp. 352-56. (Year: 2009)) and as optionally evidenced by Angiolillo et al. (“Angiolillo”, Am. J. Cardiovasc. Drugs, 17: pp. 97-107, 2017; cited by Applicant in the IDS filed June 15, 2023 and present in the file wrapper of grandparent Application No. 15/520,731).
Applicant Claims
Applicant claims an oral pharmaceutical dosage form comprising a capsule containing therein at least two tablets that comprise an analgesic that is naproxen, an expectorant that is guaifenesin, at least one additional active pharmaceutical ingredient, wherein the at least two tablets have different dimensions and a single dose of the oral pharmaceutical dosage form provides a therapeutic effect such that it can be appropriately dosed once in a 12-hour period.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Regarding claims 1 and 3, Davis teaches pharmaceutical sustained release formulations of guaifenesin and at least one additional drug ingredient (e.g., abstract), wherein the additional drug ingredient may include an antitussive such as dextromethorphan hydrobromide, and an analgesic such as naprosin (i.e., naproxen) (e.g., paragraph [0045]). Dextromethorphan is preferred and exemplified (e.g., see paragraph [0045]; Figs. 13 and 14; Example 8). Davis does not exemplify a formulation additionally comprising naproxen; however, since Davis fairly teaches and suggests the presence of naproxen as a suitable additional drug ingredient, it would be within the purview of the skilled artisan to include naproxen in the formulation, with a reasonable expectation of success, according to consumer preference (e.g., if an analgesic effect is desired). Davis teaches the formulation may be a modified release product which has two portions: a first portion having an immediate release formulation of guaifenesin and a second portion having a sustained release formulation of guaifenesin, wherein one or both portions has at least one additional drug ingredient (e.g., see abstract; paragraphs [0018], [0066]). The compositions may be in the form of a capsule having beads or granules of immediate release formulation and beads or granules of sustained release formulation (e.g., paragraphs [0018], [0019)).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Davis does not specifically teach the limitation wherein the capsule comprises two tablets containing different pharmaceutically active ingredient(s) and having different dimensions. This deficiency is cured by the teachings of Kim et al., set forth below.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01) & Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Kim teaches a hard capsule composite formulation comprising tablets having a shape conforming to the internal space of the capsule (e.g., abstract). The tablets may have different dimensions, and different geometric forms (e.g., Figure 1). The term “composite formulation” refers to a combination of two or more different active ingredients (e.g., paragraph [0005]). The tablets may have different dimensions, and different geometric forms (e.g., Figure 1). The composite formulation exhibits good dissolution rate because pharmaceutically active ingredients contained in the capsule are separated from one another, and thus the ingredients are less affected by the dissolution rate of one another, allowing good storage stability which can optimize the therapeutic effects (e.g., abstract).
It would have been obvious to a person having ordinary skill in the art at the time the invention was filed to formulate the capsule formulation of Davis as a composite capsule formulation comprising two tablets having different dimensions; thus, arriving at the claimed invention. One skilled in the art would be motivated to do so, with a reasonable expectation of success, because formulating the composition as a capsule comprising two tablets of different dimensions provides the benefits of good dissolution rate as well as good storage stability which can optimize the therapeutic effects, as taught by Kim.
Regarding claims 1 and 3, Davis teaches a preferred additional drug ingredient may be dextromethorphan (e.g., paragraph [0045]), and exemplifies formulations comprising a “substantial” amount of guaifenesin and dextromethorphan in the sustained (i.e., modified) release portion, and wherein guaifenesin and dextromethorphan are present in both the immediate and sustained (i.e., modified) release portions (e.g., see Example 8). Additionally, naproxen is known to have a much longer half-life, approximately 12-17 hours (as evidence, see Angiolillo, page 99). Moreover, regarding the combination of guaifenesin and analgesics, Sliva reported that guaifenesin has been used worldwide as an expectorant in numerous OTC preparations for many years (pp. 352, left column, Introduction); a fixed combination of guaifenesin with paracetamol and caffeine (Ataralgin) has been extensively used as an OTC analgesic in the Czech and Slovak Republics since 1981 and is still widely used (Id. at right column); Sliva previously demonstrated that guaifenesin enhances analgesia induced by paracetamol (also known as acetaminophen) (Id. at abstract); and results suggest that guaifenesin might enhance the analgesic activity of various non-steroidal anti-inflammatory drugs, i.e., ibuprofen, nimesulide, and celecoxib (Id.) Thus, it would have been prima facie obvious to specifically include a non-steroidal analgesic in formulations comprising guaifenesin due to the expectation of improved analgesic effects with a reasonable expectation of success. The person of ordinary skill in the art would have been motivated to ensure the combination suggested by Davis, as modified by Kim, included a non-steroidal anti-inflammatory drug, such as naproxen, due to the known analgesia-enhancing effects of guaifenesin and the fact that naproxen has a longer half-life of approximately 12-17 hours.
Davis further teaches the immediate release formulation is formulated to dissolve in aqueous acidic medium, such as that found in the stomach, while the sustained release form releases some in the stomach as is sustained over time (e.g., paragraphs [0018], [0042], [0047], [0052]). Accordingly, the ordinary skilled artisan would have found it obvious to include guaifenesin in both immediate and sustained release formulations, while also including naproxen in an immediate release formulation, due to its longer half-life.
Regarding claim 2, Kim teaches the ingredients of the composite formulation exhibit good dissolution rate because the actives are separated from one another, and thus the ingredients are less affected by the dissolution rate of one another (e.g., abstract), and thus their release would be comparable to administering each tablet separately.
Regarding dimensions of the capsule (claims 4-6), Kim teaches capsules of length 21.7-23.3 mm and width/depth of 7.6-8.5 mm are known (e.g., paragraph [0009]), with smaller dimensions being preferred for those who may have difficulty swallowing (Id.), and exemplifies tablets (and resulting capsules) of smaller dimensions (e.g., paragraphs [0050], [0054]). Therefore, it would be within the purview of the skilled artisan to formulate capsules having dimension the same as or similar to those recited in the claims, with a reasonable expectation of success. Accordingly, the particular dimensions recited do not impart patentability to the claims, absent a showing of unexpected results for the particular dimensions claimed.
Regarding choices of excipients present (claims 15, 25, 28, 30, 34, and 35), Davis teaches the formulation may comprise a hydrophilic polymer, preferably a hydroxypropyl methylcellulose (e.g., abstract; paragraph [0046]), and also may comprise excipients such as microcrystalline cellulose, povidone, magnesium stearate, sodium starch glycolate, and carbomer (e.g., paragraphs [0050], [0051], [0068]; claims 9-11, 14). Regarding amounts of components in the formulation, it is noted that, while Davis does not specifically teach amounts of components identical to those instantly claimed, the optimum amounts of the presently claimed active agents and excipients would have been a matter well within the insight of one of ordinary skill in the art. Such a determination would have been made in accordance with a variety of factors, such as the route of administration, pharmacological considerations, such as the activity, efficacy, pharmacokinetics and toxicology profiles of the combination regimen, as well as the age, weight, sex, diet and medical condition of the patient, and the severity of the condition. Thus, the determination of the optimum or workable amounts given the guidance of the prior art would have been generally prima facie obvious to the ordinary skilled artisan. Please see MPEP 2144.05 [R-2] (II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (“[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation."). Accordingly, the particular amounts claimed do not impart patentability to the claims, absent a showing of the criticality of the particular amounts claimed.
The Examiner notes that Applicant’s specification filed on June 15, 2023 does not contain any assertions of unexpected results, synergy, and/or long-felt need in the prior art to solve any particular problem. The Examiner notes that the instant application also does not appear to have any data presented. The examples appear to be limited to merely exemplified formulations and provide no comparisons to evidence that the claimed oral pharmaceutical formulation is characterized by any special properties that might be considered unexpected, such as, for example, evidence of synergy. Thus, there are no secondary considerations present or asserted in the instant application as filed that would need to be considered in making the aforementioned prima facie finding of obviousness.
Response to Arguments
Applicant's arguments filed March 2, 2026 have been fully considered but they are not persuasive. Although the above 103 rejection has been modified slightly by the incorporation of the previously dependent claim limitations into the independent claim, it remains essentially the same. Thus, Applicant’s arguments regarding the combination of Davis and Kim, as optionally evidenced by Angiolillo are addressed herein below.
Beginning at numbered page 6 of Applicant’s arguments/remarks (first page in the document), it appears that Applicant is arguing that the claimed oral pharmaceutical dosage form solves a long-felt need and for this reason is unobvious.
Applicant’s argument is understood to be an assertion of solving an unfelt need is unpersuasive, because Applicant has not provided objective evidence that (1) an art-recognized problem existed in the art for a long period of time without solution, (2) that the long-felt need must not have been satisfied by another before the invention of the inventor, and (3) that the claimed invention in fact does satisfy the asserted long-felt need. Moreover, Applicant is reminded that the failure to solve a long-felt need may be due to factors such as lack of interest or lack of appreciation of an invention’s potential or marketability rather than the want of technical know-how. See MPEP § 716.04. It should be further noted that applicant’s argument of the existence of a long-felt need is not a substitute for providing objective evidence of the same.
Applicant’s arguments also discuss the difficulty of ensuring patient compliance with treatment when the patient is required to take more than one drug. However, the Examiner notes that this particular problem was recognized by Kim and solved by Kim’s teachings of including two or more tablets each tablet comprising a different active pharmaceutical ingredient within a hard capsule. Thus, the combination of references in the instant obviousness rejection addresses and solves this challenge as it pertains to the combination of an analgesic (e.g., naproxen), an expectorant (e.g., guaifenesin), and at least one additional active pharmaceutical ingredient, such as dextromethorphan or pseudoephedrine.
On pages 8-10 (page 3-5 in the document), Applicant traverses the essence of the above rejection by attacking the Kim and Davis references individually. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See 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).
Additionally, Applicant contends that there is no motivation to combine the disclosures of Davis, Kim and Sliva because there would not have been a reasonable expectation of success in combining the specifically claimed components in the specifically claimed amounts of the present invention. The Examiner notes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the Examiner specifically provided a rationale to combine. As noted in the rejection, it would have been within the purview of the skilled artisan to include naproxen in the formulation, with a reasonable expectation of success, according to consumer preference (e.g., if an analgesic effect is desired). Furthermore, the ordinary skilled artisan would have found it obvious to include guaifenesin in both immediate and sustained release formulations, while also including naproxen in an immediate release formulation, due to its longer half-life.
Applicant’s other arguments essentially repeat the same arguments addressed in the Final office action mailed on October 2, 2025. The rebuttal of these arguments is incorporated herein by reference.
Consequently, claims 1-6, 15, 25, 28, 30, 34, and 35 are rejected. Claim 37 is withdrawn.
Conclusion
No claims are allowed.
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/SAHAR INAM/
Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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