DETAILED ACTION
Status of Claims
Claims 1, 4, 14, 17 and 19 are currently pending and are the subject of this Office Action. This is the first Office Action on the merits of the claims. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Office Action: Non-Final
Claim Objections
The following claims are objected to because of the following informalities: Claim 19 is objected to because the claim should read:
19. ([…]) A composition as claimed in claim 1, wherein the composition comprises:
(a) 50[[-]] to 85% [[G]]guaifenesin;
(b) up to 5% [[D]]dextromethorphan or a pharmaceutically acceptable salt thereof; and
(c) 5[[-]] to 30% [[N]]naproxen or a pharmaceutically acceptable salt thereof.
Appropriate correction is required.
Claim Rejections – 35 U.S.C. § 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.
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 pre-AIA 35 U.S.C. § 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. 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 C.F.R. § 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, 4, 14, 17 and 19 are rejected under 35 U.S.C. § 103 as being unpatentable over DAVIS (US 2003/0049318 A1, Publ. Mar. 13, 2003; on 04/25/2025 IDS; hereinafter, “Davis”), in view of STILLNER (Stillner, et al., Biobehavioral Changes in Prolonged Competitive Stress Observations of Iditarod Trail Sled Dog Mushers, Al. Med. 24 (Jan./Feb. 1982) pp. 1-6; hereinafter, “Stillner”).
Davis is directed to:
SUSTAINED RELEASE FORMULATIONS OF GUAIFENESIN AND ADDITIONAL DRUG INGREDIENTS
ABSTRACT
The invention relates to a novel pharmaceutical sustained release formulation of guaifenesin and at least one additional drug ingredient. The formulation may comprise a hydrophilic polymer, preferably a hydroxypropyl methylcellulose, and a water-insoluble polymer, preferably an acrylic resin, in a ratio range of about one-to-one (1:1) to about nine-to-one (9:1), more preferably a range of about three-to-two (3:2) to about six-to-one (6:1), and most preferably in a range of about two-to-one (2:1) to about four-to-one ( 4:1) by weight. This formulation capable of providing therapeutically effective bioavailability of guaifenesin for at least twelve hours after dosing in a human subject. The invention also relates to 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. The modified release product has a maximum guaifenesin serum concentration equivalent to that of an immediate release guaifenesin tablet, and is capable of providing therapeutically effective bioavailability of guaifenesin for at least twelve hours after dosing in a human subject.
Davis, title & abstract. In this regard, Davis teaches an exemplary embodiment directed to a bilayer tablet with a sustained release (SR) layer containing guaifenesin with dextromethorphan HBr, and an immediate release (IR) layer containing guaifenesin with dextromethorphan HBr :
Example 8
[0122] Two batches of guaifenesin/dextromethorphan HBr bi-layer tablets, one 600 mg and one 1200 mg, were prepared according to the following composition. In the 30 mg dextromethorphan tablet 7.5 mg was within the immediate release layer and 22.5 mg within the modified release layer.
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[0123]
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Davis, par. [0122]-[0123], Ex. 8.
Regarding independent claim 1 and the requirements:
1. ([…]) A pharmaceutical composition comprising a pharmaceutically effective amount of guaifenesin, naproxen and at least one further active which is selected to be an antitussive, a decongestant or an antihistamine.
Davis teaches a bilayer tablet with a sustained release (SR) layer containing guaifenesin with dextromethorphan HBr, and an immediate release (IR) layer containing guaifenesin with dextromethorphan HBr (Davis, par. [0122]-[0123], Ex. 8), WHEREBY it is noted:
guaifenesin in both the sustained release (SR) layer and an immediate release (IR) layer (Davis, par. [0123], Ex. 8) meets the instant requirements for “guaifenesin” of claim 1, as well as the requirements of claims 14 and 17 for:
14. ([…]) A composition as claimed in claim 1, wherein composition comprises immediate and sustained release portions.
[…]
17. ([…]) A composition as claimed in claim 14, wherein the composition is provided with both sustained-release and immediate-release portions comprising guaifenesin.
“dextromethorphan HBr” in both the sustained release (SR) layer and an immediate release (IR) layer (Davis, par. [0123], Ex. 8) meets the instant requirements for “at least one further active which is selected to be an antitussive, a decongestant or an antihistamine” of claim 1, as well as the requirements of claim 4 for:
4. ([…]) A composition as claimed in claim 1, wherein the at least one further active is dextromethorphan.
However, it is noted that although Davis broadly teaches “the sustained release formulation may comprise a combination of guaifenesin and at least one additional drug,” inter alia, “dextromethorphan hydrobromide” and “naprosin”:
[0045] In one embodiment of the present invention, a sustained release formulation comprises guaifenesin and at least one drug ingredient both mixed with a polymer blend which comprises at least one hydrophilic polymer and at least one water-insoluble polymer. In a further embodiment, the sustained release formulation may comprise a combination of guaifenesin and at least one additional drug ingredient, wherein the additional drug ingredient includes, but not limited to, an antitussive such as dextromethorphan hydrobromide, codeine, hydrocodone, a decongestant such as phenylephrine hydrochloride, phenylpropanolamine hydrochloride, pseudoephedrine hydrochloride or ephedrine, an antihistamine such as chlorpheniramine maleate, brompheniramine maleate, phenindamine tartrate, pyrilamine maleate, doxylamine succinate, phenyltoloxamine citrate, diphenhydramine hydrochloride, promethazine, and clemastine fumerate, an analgesic such as aspirin, ibuprofen, naprosin, and acetaminophen, or combinations thereof. Preferably, the drug ingredient is dextromethorphan hydrobromide, pseudoephedrine hydrochloride, or a combination thereof.
(Davis, par. [0045]), wherein “naprosin” is noted as “naproxen” of claim 1 (see Stillner, p. 2, par. 5 as evidence that “naprosin” is “naproxen”), DAVIS DOES NOT EXPRESSLY TEACH an exemplary embodiment thereof in combination with “guaifenesin” and “dextromethorphan HBr” per the requirements of claim 1, which is well within the purview of the ordinarily skilled artisan. In this regard, it is noted that a reference is analyzed using its broadest teachings. MPEP § 2123 [R-5] states: “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to rearrange Davis’ bilayer tablet (Davis, par. [0122]-[0123], Ex. 8), per Davis’ broader disclosure, to incorporate “naprosin” as “at least one additional drug” (Davis, par. [0045]).
Regarding claim 1 and the requirement for a “pharmaceutically effective amount” of “guaifenesin, naproxen and at least one further active,” as well as the requirements of claim 19 for:
19. ([…]) A composition as claimed in claim 1, wherein the composition comprises:
(a) 50-85% Guaifenesin;
(b) up to 5% Dextromethorphan or a pharmaceutically acceptable salt thereof; and
(c) 5-30% Naproxen or a pharmaceutically acceptable salt thereof.
Davis teaches suitable amounts of “guaifenesin” and “additional drug ingredient”:
[0051] A sustained release formulation of the present invention can comprise at least two drug ingredients, at least one hydrophilic polymer, at least one water-insoluble polymer, and at least one pharmaceutical additive in any appropriate percent quantity which permits dissolution of drug ingredients that results in a therapeutically effective serum concentration profile for a full twelve hours. In a preferred embodiment, a sustained release formulation comprises from about 75% to about 95% guaifenesin by weight, from about 1 % to about 15% by weight of a additional drug ingredient, from about 1 % to about 10% hydroxypropyl methylcellulose, from about 0.5% to about 2.5% acrylic resin, from about 0.4% to about 1.5% magnesium stearate, and from about 0.01 % to about 1 % colorant by weight. In a more preferred embodiment, a sustained release formulation comprises from about 80% to about 90% guaifenesin by weight, from about 3% to about 10% by weight of a additional drug ingredient, from about 2% to about 5% hydroxypropyl methylcellulose, from about 1 % to about 1.5% acrylic resin, from about 0.7% to about 1 % magnesium stearate, and from about 0.03% to about 0.13% colorant by weight.
(Davis, par. [0051]), whereby one would be motivated to formulate Davis’ bilayer tablet (Davis, par. [0122]-[0123], Ex. 8) with:
guaifenesin (Davis, par. [0123], Ex. 8), wherein the “sustained release formulation comprises from about 75% to about 95% guaifenesin by weight” (Davis, par. [0051]);
“dextromethorphan HBr” (Davis, par. [0123], Ex. 8) as “at least one additional drug” (Davis, par. [0045]), wherein “sustained release formulation comprises […], from about 1 % to about 15% by weight of a additional drug ingredient” (Davis, par. [0051]); AND
“naprosin” as “at least one additional drug” (Davis, par. [0045]), wherein “sustained release formulation comprises […], from about 1 % to about 15% by weight of a additional drug ingredient” (Davis, par. [0051]).
In this respect, it is noted that MPEP § 2144.05 (I), states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d, 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).”
Thus, Davis renders claims 1, 4, 14, 17 and 19 obvious.
Claim Rejections - Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 4, 14, 17 and 19 are rejected on the ground of nonstatutory double patenting over claims 1 and 5 of US 11,278,506 B2 to Cavatur et al., hereinafter “‘506 Patent,” matured from copending Application No. 15/291,061.
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims are drawn to a pharmaceutical composition comprising guaifenesin, naproxen and at least one further active such as dextromethorphan.
Claim 1 is anticipated by claim 1 of the ‘506 Patent.
Claim 4 is anticipated by claim 1 of the ‘506 Patent.
Claim 14 is anticipated by claim 1 of the ‘506 Patent.
Claim 17 is anticipated by claim 1 of the ‘506 Patent.
Claim 19 is obvious over by claims 1 and 5 of the ‘506 Patent. It is noted that dosage/amount of active ingredient is a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). Therefore, an ordinary skilled artisan would also be motivated to manipulate and optimize the dosage depending on a patient’s weight, age, tolerance, sex, and condition being treated.
Claims 1, 4, 14, 17 and 19 are rejected on the ground of nonstatutory double patenting over claims 1 and 5 of US 12,370,189 B2 to Cavatur et al., hereinafter “‘189 Patent,” matured from copending Application No. 17/486,225.
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims are drawn to a pharmaceutical composition comprising guaifenesin, naproxen and at least one further active such as dextromethorphan.
Claim 1 is anticipated by claim 1 of the ‘189 Patent.
Claim 4 is anticipated by claim 1 of the ‘189 Patent.
Claim 14 is anticipated by claim 1 of the ‘189 Patent.
Claim 17 is anticipated by claim 1 of the ‘189 Patent.
Claim 19 is obvious over claims 1 and 5 of the ‘189 Patent. It is noted that dosage/amount of active ingredient is a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). Therefore, an ordinary skilled artisan would also be motivated to manipulate and optimize the dosage depending on a patient’s weight, age, tolerance, sex, and condition being treated.
Claims 1, 4, 14, 17 and 19 are rejected on the ground of nonstatutory double patenting over claims 1 and 5 of US 12,257,218 B2 to Cavatur et al., hereinafter “‘218 Patent,” matured from copending Application No. 17/667,746.
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims are drawn to a pharmaceutical composition comprising guaifenesin, naproxen and at least one further active such as dextromethorphan.
Claim 1 is anticipated by claim 1 of the ‘218 Patent.
Claim 4 is anticipated by claim 1 of the ‘218 Patent.
Claim 14 is anticipated by claim 1 of the ‘218 Patent.
Claim 17 is anticipated by claim 1 of the ‘218 Patent.
Claim 19 is obvious over claims 1 and 5 of the ‘218 Patent. It is noted that dosage/amount of active ingredient is a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). Therefore, an ordinary skilled artisan would also be motivated to manipulate and optimize the dosage depending on a patient’s weight, age, tolerance, sex, and condition being treated.
Claims 1, 4, 14, 17 and 19 are provisionally rejected on the ground of nonstatutory double patenting over claims 1, 15, 25, 28 and 34-35 of copending Application No. 18/335,355 (‘355 Application). This is a provisional double patenting rejection since the conflicting claims have not in fact been patented.
Claim 1 is anticipated by claim 1 of the ‘355 Application.
Claim 4 is anticipated by claim 1 of the ‘355 Application.
Claim 14 is anticipated by claim 1 of the ‘355 Application.
Claim 17 is anticipated by claim 1 of the ‘355 Application.
Claim 19 is anticipated by claims 15, 25, 28 and 34-35 of the ‘355 Application.
Claims 1, 4, 14, 17 and 19 are provisionally rejected on the ground of nonstatutory double patenting over claims 1-7, 23-25 and 30 of copending Application No. 19/027,910 (‘910 Application). This is a provisional double patenting rejection since the conflicting claims have not in fact been patented.
Claim 1 is anticipated by claim 1 of the ‘910 Application.
Claim 4 is anticipated by claim 1 of the ‘910 Application.
Claim 14 is anticipated by claims 2-7 of the ‘910 Application.
Claim 17 is anticipated by claims 6 of the ‘910 Application.
Claim 19 is anticipated by claims 23-25 and 30 of the ‘910 Application.
Conclusion
Claims 1, 4, 14, 17 and 19 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out.
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/DOMINIC LAZARO/Primary Examiner, Art Unit 1611
