DETAILED ACTION
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 .
Status of Claims
Claims 1, 5-7, 15-16, 19, 21, 26-27, 32, 43, 46, 52 and 156-159 are pending.
Priority
Instant application 17/429,761, filed 08/10/2021 claims priority as follows:
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Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Amendment
The amendment filed 12/22/2025 has been entered. Applicant has amended claims 1, 5-7, 15-16, 19, 21, 26-27, 32, 43, 46, 52 and 156.
In view of the amendments to the claims, applicant has overcome the previous rejection under section 103 over BEECH in view of MCNALLY and ZIETSMAN; and the previous double patenting rejection over US 9,138,482 B2 in view of MCNALLY and ZIETSMAN.
However, in view of the amendments to the claims, new grounds for rejection are presented below.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 1, 5-7, 15-16, 19, 21, 26-27, 32, 43, 46, 52 and 156 are rejected under 35 U.S.C. 103 as being unpatentable over:
BEECH (US 20140296342 A1; 2014; cited previously) in view of
HASLWANTER (US6565832B1; 2003; cited in IDS), further in view of
MCNALLY (US 20180147285 A1; 2018; cited previously), as evidenced by
SHARPE (Drug Development and Industrial Pharmacy, vol. 29, no. 9, Jan. 2003, pp. 1005–12)
Applicants Invention
The instant claims are drawn to a composition comprising a pharmaceutically active ingredient, a solubilizing agent, and a thixotropic agent. The specification is drawn particularly to a thixotropic composition for administration of an NSAID (particularly flurbiprofen).
Applicant states that a common problem with spray administration is low retention of the applied formulation due to structure of body cavities. Due to drainage of the formulation from the applied area and subsequent swallowing of much of the formulation, a large portion of the active agent introduced into the mouth/nose is generally rendered unavailable for its intended use.
Applicant claims that the present invention provides an aqueous-based sprayable composition which comprises a thixotropic material. The composition exhibits a reduced apparent viscosity while being subjected to shear forces (e.g., when shaken) but a high apparent viscosity while at rest (e.g., during storage, or after application to mucosal membranes).
Beech
Beech is drawn to pharmaceutical compositions in the form of a throat spray/aerosol comprising NSAIDs (particularly flurbiprofen), and cyclodextrin (abstract, [0001], and claims 1-29). The disclosure of Beech provides that the cyclodextrin enables a significantly higher concentration of NSAID per fluid volume than previous compositions ([0006]-[0007]).
Beech discloses compositions comprising the active ingredient flurbiprofen, the solubilizing agent cyclodextrin, and the thixotropic agent hydroxyethylcellulose (see the compositions disclosed at page 2, [0039]). More broadly, Beech discloses multiple solubilizing agents (e.g., claim 6) and multiple thixotropic agents (e.g., claim 39) in the composition. Beech additionally discloses disodium hydrogen phosphate, citric acid monohydrate, and sodium hydroxide in the compositions (page 2, [0039]). The compositions disclosed in Beech are sprayable (e.g., [0001]).
The primary differences between the compositions of Beech and the composition of claim 1 are that the compositions of Beech:
(1) do not comprise a combination including one or more celluloses and one or more alkali metal carboxycelluloses in the recited ratio (85-95 : 5-15) and in an amount from about 1.5 to about 10 w/w%; and
(2) do not have a disclosed low shear viscosity of between 50-60 Pascal seconds at a low shear rate of 0.1 s-1.
Haslwanter
Haslwanter is drawn to an aqueous-based sprayable composition comprising a therapeutic agent, water, and a mixture of microcrystalline cellulose and alkali metal carboxyalkylcellulose, characterized as a non-Newtonian nasal spray exhibiting a very rapid viscosity recovery upon removal of shear forces (abstract). Haslwanter states (col. 1, lines 26-45) that a common problem with spray administration is a low efficiency of the active agent, since the structure of body cavities and parts does not typically facilitate retention of the applied formulation. This is particularly the case for aqueous-base nasal spray formulations, which must have sufficient fluidity to be dispensed by a pump device or a squeeze-type spray bottle, but which can simply drain from the nose or pass through the nose and into the pharynx while, or immediately after, being sprayed. Due to swallowing of much of the formulation which enters the oropharyngeal area, a large portion of the active agent introduced into the nose is generally rendered unavailable for its intended use.
Haslwanter discloses that mixtures of microcrystalline cellulose (MCC) and alkali metal (sodium) carboxyalkylcelluose (CMC) are commercially available, the mixtures preferred for use being sold as AvicelTM RC-591 or the closely related AvicelTM RC-581 (col. 3, lines 45-64). Haslwanter also discloses that MCC and CMC are commercially available separately, and can be mixed in desired proportions; a preferred amount of MCC is between about 85 and 95 weight percent of the mixture relative to CMC (col. 4, lines 1-9). Haslwanter further teaches that the compositions contain at between about 2.5 weight percent and about 10 weight percent of the MCC/CMC agent (col. 3, lines 55-64).
Haslwanter additionally teaches that it may be desirable to incorporate up to about 10 weight percent of an additional rheology-modifying agent, such as xanthan gum (col. 4, lines 21-32).
McNally
McNally discloses compositions useful in the treatment of cough and cold symptoms, including cough, nasal congestion, and sore throat. McNally describes a problem with prior art sprays and lozenges for treating sore throat, stating: “In many cases, sprays or liquids do not provide extended pain relief because the composition is swallowed almost immediately upon ingestion.” (page 1, para. [0006]). Further, McNally provides a solution to the above-described problem in the form of compositions comprising a muco-adhesive material; i.e. a thixotropic agent. McNally states that an advantage of the compositions is that they provide a thin layer coating on oral surfaces, and enhance the sensory experience as compared to known compositions (page 2, para. [0013]).
McNally discloses compositions comprising an active pharmaceutical agent selected from ibuprofen, flurbiprofen, ketoprofen; and a mucoadhesive material selected from Avicel® BV 2219, Avicel® CL 611, Avicel® RC 591, which are thixotropic agents comprising a combination of CMC and MCC (claims 1, 3-5; [0060]; [0063]; Examples 5 and 6). McNally additionally discloses xanthan gum as a muco-adhesive material and/or thickener ([0015]).
Finding of prima facie obviousness
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationales A, C, and/or G, it would have been prima facie obvious to modify the compositions disclosed in Beech by adding a thixotropic agent comprising a mixture of MCC and alkali metal CMC, wherein the MCC is between about 85 and 95 weight percent of the mixture relative to the alkali metal CMC, and wherein the thixotropic agent is present in an amount between about 2.5 weight percent and about 10 weight percent as taught by Haslwanter.
While Haslwanter discloses nasal spray compositions, Haslwanter also contemplates oropharyngeal applications (col. 3, lines 33-39). Moreover, McNally is directed to the throat/pharyngeal area and teaches using Avicel MCC/CMC products (including the Avicel 591 preferred by Haslwanter) as a mucoadhesive/thixotropic agent, includes NSAIDs (particularly flurbiprofen) among its active ingredients, and teaches spray compositions.
A skilled artisan would have been motivated to incorporate the thixotropic agent in order to provide a throat spray with improved adhesion to throat tissues after application. A skilled artisan would have reasonably predicted that modifying Beech’s composition to incorporate the known agents sodium CMC and MCC would result in a composition having non-Newtonian thixotropic properties and improved stability because these agents were known for that purpose in the prior art.
With respect to the new limitation requiring that the composition of claim 1 has “a low shear viscosity of between 50-60 Pascal seconds at a low shear rate of 0.1 s-1”, this limitation does not render the claims non-obvious because low shear viscosity is a known result-effective variable that scales with MCC/CMC concentration. McNally reports the viscosity of a composition comprising 2.0% Avicel CL-611 as 16.61 Pa-s at a shear rate of 0.1 s-1 (McNally, Table 11).
Sharpe is relied upon as evidence that the viscosity and thixotropy of MCC/CMC-based spray formulations are known result-effective variables that scale directly and predictably with MCC/CMC concentration. Sharpe reports that Nasonex (containing 2% Avicel) exhibited 3.4-21.4 times greater final viscosity than products with lower Avicel concentrations (Sharpe, Table 1, Table 2, p. 1008-1009). Sharpe explicitly attributes this relationship to concentration: “The formulations containing higher concentrations of the structure-building components MCC and CMC sodium exhibited the highest level of thixotropy (i.e., Nasonex AQ). This high level of thixotropy is a direct consequence of the concentration of the structure-building element.” (Sharpe, p. 1011, Discussion). Sharpe further states that the yield stress differences “may be attributed to the different strengths of the polymer networks produced by components such as MCC and CMC” (Sharpe, p. 1011).
McNally’s 16.61 Pa-s for Avicel 611 at 0.1 s-1 is measured at a concentration of 2.0% Avicel. Increasing the Avicel concentration to 2.5-5%, which is the preferred range taught by Haslwanter (Haslwanter, col 3, lines 60-64) and the range used in applicant’s own working examples (specification, page 49, Examples 1-4) would, per the concentration-viscosity relationship established by Sharpe, predictably increase viscosity within the claimed 50-60 Pa-s range. This constitutes routine optimization of a known result-effective variable.
MPEP 2144.05 notes that differences in result-effective variables will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating the value of the result-effective variable is critical. However, the specification provides no evidence of criticality. No comparative data is provided to demonstrate that compositions outside the low shear viscosity range of 50-60 Pa-s fail to spray or fail to adhere to mucosal tissue. To the contrary, the specification confirms that the rheological values are a direct function of the MCC/CMC concentration: page 40, lines 8-14 disclose a yield point of 2-8 Pa at 1.5-2.4% MCC/CMC, or a yield point of 10-16 Pa at 2.4-3.0% MCC/CMC, demonstrating that the yield point is a dependent variable dictated by the concentration of the thixotropic agent rather than an independently optimized parameter. According to MPEP 2144.05, where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill unless the applicant demonstrates the criticality of the claimed range.
Moreover, as noted in MPEP 2145 and In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979), the mere recognition of latent properties in the prior art does not render non-obvious an otherwise obvious invention. The recitation of rheological parameters that are the natural and expected consequence of combining known ingredients at known concentrations does not impart patentability.
Therefore, claims 1, 5-6, 16, and 21 are obvious over Beech in view of Haslwanter and McNally, as evidenced by Sharpe.
With respect to claim 7, Beech teaches a preferred flurbiprofen concentration of 1-5% (para. [0017]), with particular embodiments having 1.62% (para. [0040]).
With respect to claim 15, Haslwanter teaches MCC/CMC in a preferred weight percentage of 2.5-5% (col 3, lines 60-64).
With respect to claim 19, Beech teaches cyclodextrin concentrations of 5-10% (para. [0017]), particularly 6.04% or 4.23% (para. [0040]).
With respect to claim 26, Beech teaches the stabilizer hydroxyethyl cellulose in an amount of 0.20% w/w.
With respect to claim 27, Beech teaches adding ethyl cellulose or hydroxypropyl methyl cellulose in amounts of up to 0.5% (para. [0023]). Haslwanter teaches xanthan gum in an amount of about 0.5 to about 5 w/w% (col. 4, lines 21-32).
With respect to claim 32, Beech teaches a pH of the liquid formulations disclosed there in of about 7.4 ([0014] and [0038]).
With respect to claims 43, the combination of references teaches a composition comprising the recited ingredients as set forth above. As noted for claims 7, 15, 19, and 26-27, and 32 the combination teaches amounts of the NSAID, MCC/CMC, cyclodextrin, and stabilizer reading on the recited amounts. Beech teaches disodium hydrogen orthophosphate, sodium hydroxide and citric acid (pH adjusters) in concentrations of 3.18 %, 0.24 %, and 0.117 %, respectively. Further, Beech teaches up to 5% of one or more aqueous buffers.
With respect to claim 46, the combination of references teaches a composition comprising the recited ingredients as set forth above. As noted for claims 7, 15, 19, and 26-27, and 32 the combination teaches amounts of the NSAID, MCC/CMC, cyclodextrin, and stabilizer reading on the recited amounts. Beech teaches disodium hydrogen orthophosphate, sodium hydroxide and citric acid (pH adjusters) in concentrations of 3.18 %, 0.24 %, and 0.117 %, respectively. Further, Beech teaches up to 5% of one or more aqueous buffers.
With respect to claim 52, the combination of references teaches a composition comprising the recited ingredients as set forth above. As noted for claims 7, 15, 19, and 26-27, and 32 the combination teaches amounts of flurbiprofen, MCC/CMC, beta cyclodextrin and hydroxypropyl beta cyclodextrin, and stabilizer reading on the recited amounts. Beech teaches disodium hydrogen orthophosphate, sodium hydroxide and citric acid (pH adjusters) in concentrations of 3.18 %, 0.24 %, and 0.117 %, respectively. Further, Beech teaches up to 5% of one or more aqueous buffers.
With respect to claim 156, the combination of references teaches a composition comprising the recited ingredients as set forth above. As noted for claims 7, 15, 19, and 26-27, and 32 the combination teaches amounts of flurbiprofen, MCC/CMC, cyclodextrin, and stabilizer reading on the recited amounts. Beech teaches disodium hydrogen orthophosphate, sodium hydroxide and citric acid (pH adjusters) in concentrations of 3.18 %, 0.24 %, and 0.117 %, respectively. Further, Beech teaches up to 5% of one or more aqueous buffers.
With respect to claims 157-159, the combination of references teaches a composition comprising the recited ingredients as set forth above. With respect to the new viscosity recovery rate limitation, Haslwanter teaches thixotropic Avicel RC-591 spray compositions having “a very rapid rate of viscosity recovery, following withdrawal of the shearing force” (Haslwanter, col. 2, lines 25-30). Haslwanter claims compositions wherein the “complex viscosity of the composition increases to at least about 10 times a minimum complex viscosity of the composition as measured under high shear conditions, within about 20 seconds after the high shear conditions terminate” (Haslwanter, claims 1 and 5). While Haslwanter measures recovery in terms of complex viscosity ratio rather than percentage of initial viscosity, both metrics characterize the same physical phenomenon (the reformation of the MCC/NaCMC hydrogen-bonded gel network following cessation of shear).
As evidenced by Sharpe, this rapid structural recovery is a characteristic and well-understood property of MCC/CMC-based thixotropic systems. Sharpe teaches that the thixotropy of such systems “reflects the finite time taken to move from any one state of microstructure to another and back again” and that “[t]he driving force for microstructural change in flow is the result of the competition between breakdown due to flow stresses, build-up due to in-flow collisions, and Brownian motion” (Sharpe, p. 1010, Discussion). Sharpe further teaches that formulations with higher MCC/CMC concentrations exhibit greater thixotropy (Sharpe, p. 1011: “this high level of thixotropy is a direct consequence of the concentration of the structure-building element”), which encompasses both higher absolute viscosity and faster structural recovery, because stronger gel networks (produced by higher concentrations of the structure-building MCC/CMC components) reform more rapidly after disruption by sheer.
The combination of prior art references renders obvious a composition that is substantially identical in its structure-building components (MCC at 85-95 w/w %, CMC at about 5-15 w/w/%, and MCC/NaCMC at 2.5-5 w/w %) to the claimed composition, and the prior art teaches that rapid viscosity recovery is a characteristic property of such compositions (Haslwanter, col 2, lines 25-30 and claims 1 and 5). The claimed recovery rate (90 % of initial viscosity within 30 seconds) is presumed to be an inherent property of the obvious composition. See MPEP 2112.01(I); “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.”
Alternatively, should it be found that the claimed recovery rate is not strictly inherent (because the claimed compositions includes additional components not present in Haslwanter’s formulation such as cyclodextrins, buffer, NSAID) the recovery rate would nonetheless have been obvious as a predictable property of the claimed composition for the following reasons:
First, Haslwanter teaches that Avicel RC-591 compositions achieve a 10x complex viscosity increase within 20 seconds (Haslwanter, claim 5), demonstrating that rapid recovery is already achievable in MCC/CMC spray formulations and establishing recovery rate as a known, desirable property that a skilled artisan would seek to maintain or improve.
Second, as evidenced by Sharpe, recovery rate is a function of the concentration of the MCC/CMC structure-building components (Sharpe, p. 1011), which is a known result-effective variable. A skilled artisan seeking to achieve or exceed a 30-second recovery rate to 90% of the initial viscosity would have been motivated to increase the MCC/CMC concentration to the range taught by Haslwanter (2.5-5% or 2.5-3%; col 3, lines 60-64) with a reasonable expectation that the stronger gel network produced by the higher MCC/CMC concentration would recover at least as rapidly as, and likely more rapidly than, the lower concentration formulations in Haslwanter’s examples.
Third, the specification provides no evidence that the claimed 30-second / 90% viscosity recovery rate is unexpected or critical. Applicant has not presented comparative data demonstrating that standard MCC/CMC concentrations fail to achieve this recovery rate; that the presence of cyclodextrins or NSAID unexpectedly enhances or impair recovery; or that compositions falling outside the claimed 30-second recovery rate perform differently for their intended therapeutic purpose (throat retention). According to MPEP 2144.05(II), absent a showing of criticality, the claimed recovery rate represents the expected result of routine optimization of MCC/CMC concentration (a known result-effective variable) within the ranges taught by the prior art.
Moreover, as noted in MPEP 2145 and In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979), the mere recognition of latent properties in the prior art does not render non-obvious an otherwise obvious invention. The recitation of rheological parameters that are the natural and expected consequence of combining known ingredients at known concentrations does not impart patentability.
Accordingly, claims 1, 5-7, 15-16, 19, 21, 26-27, 32, 43, 46, 52 and 156 are rejected.
Response to Arguments
Applicant argues that “there is no predictability in the cited references of the use of a thixotropic agent having ’85-95% by weight of the one or more cellulose and 5-15% by weight of the one or more alkali metal carboxyalkylcellulose’ in an amount of the composition recited in the claims can be used to provide a low shear viscosity of ’50 – 60 Pascal seconds (Pa.s) at a low shear rate of 0.1 s-1” (Remarks, page 10). Applicant therefore argues that a skilled artisan would not have found it obvious or predictable in light of the combination of references to provide a thixotropic agent having 85-95% by weight cellulose and 5-15% by weight alkali metal carboxycellulose while also achieving a low shear viscosity of 50 – 60 Pa.s.
Applicants’ arguments have been fully considered but are not persuasive. In view of the modified combination of references, which provide an explicit teaching of 85-95% by weight cellulose and 5-15% by weight alkali metal carboxycellulose (Haslwanter) and evidence that viscosity and thixotropy of MCC/CMC-based spray formulations are known result-effective variables that scale directly and predictably with MCC/CMC concentration (Sharpe), a skilled person would have been motivated to incorporate MCC/NaCMC in the amounts recited by the claims and would have achieved the claimed concentration range through routine optimization within the ranges taught by the prior art.
Applicant further argues that the examiner’s rejection relies on “stacking optimization” (optimizing a variety of different variables across several references), and that “stacking optimization is an exercise in impermissible hindsight” (Remarks, page 11)
Applicant’s arguments have been fully considered but are not persuasive.
First, in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Second, please note that the rejection now cites Haslwanter, which explicitly teaches MCC/CMC ratios of 85-95% by weight MCC and 5-15% by weight CMC; and Sharpe, which explicitly teaches that viscosity and thixotropy of MCC/CMC-based spray formulations are known result-effective variables that scale directly and predictably with MCC/CMC concentration. The combination of references does not require “stacking optimization” to arrive at the claimed subject matter.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
US 9,138,482 B2
Claims 1, 5-7, 15-16, 19, 21, 26-27, 32, 43, 46, 52 and 156 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 and 26-36 of U.S. Patent No. 9,138,482 (“the ‘482 patent”) in view of:
HASLWANTER (US6565832B1; 2003; cited in IDS), further in view of
MCNALLY (US 20180147285 A1; 2018; cited previously), as evidenced by
SHARPE (Drug Development and Industrial Pharmacy, vol. 29, no. 9, Jan. 2003, pp. 1005–12)
The teachings of Haslwanter and McNally and the evidence of Sharpe are disclosed above and at least those teachings are incorporated herein by reference. The ‘482 patent issued from BEECH (US 20140296342 A1) cited in the rejection under section 103 above.
The ‘482 patent recites a liquid composition comprising 1-5% w/w flurbiprofen, cyclodextrin, citric acid, disodium hydrogen orthophosphate, sodium hydroxide, and a thickening agent selected from the group consisting of hydroxy ethyl cellulose, hydroxy propyl methyl cellulose, sodium CMC, and hydroxy propyl cellulose.
The claims of the ‘482 patent do not recite a thixotropic agent comprising MCC/CMC in the recited ratio. However, it would have been obvious to modify the compositions claimed in the ‘482 patent to include a thixotropic agent comprising MCC/CMC in the recited ratios, and to arrive at the remaining limitations of the present claims, for the same reasons and based on the same combination of teachings of McNally, Haslwanter, and Sharpe as set forth in detail in the rejection of claims 1, 5-7, 15-16, 19, 21, 26-27, 32, 43, 46, 52 and 156 under 35 U.S.C. 103 above, which rationale is incorporated herein by reference.
Response to Arguments
Applicant reiterates the arguments made in response to the rejection under 103. In response, Applicant’s arguments have been fully considered and are not persuasive. See the response to Applicant’s arguments above in the rejection under 103 which are incorporated herein by reference.
Conclusion
Claims 1, 5-7, 15-16, 19, 21, 26-27, 32, 43, 46, 52 and 156 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kyle Nottingham whose telephone number is (571)270-0640. The examiner can normally be reached M-F from 10:00 am - 6:00 pm.
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/K.N./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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