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 .
Continued Examination (RCE)
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/20/2026 has been entered.
Status of the Claims
This action is in response to papers filed 05/20/2026 in which claims 1, 9 and 11-13 were amended and claims 14-16 were newly added. All the amendments have been thoroughly reviewed and entered. Claims 1, 4-6, 9 and 11-16 are under examination.
The Examiner has re-weighted all the evidence of record. Any rejection and/or objection not specifically addressed below is hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Objection
Independent claims 1, 9 and 11-13 recites “An oral film” in preamble. It appears that the instant invention is directed to a composition of HIV/antiretroviral drugs and its pharmaceutically acceptable salt thereof in the form of oral film, wherein film forming polymers, plasticizers and other excipients are incorporated to make the oral film that disintegrates within about three minutes upon contact with salt. Although the term itself is not inherently problematic, for example, the scope of the phrase “an oral film” in claim 1 is unclear as to whether it is intended to refer to a composition or to a film material intended to coat a composition. For purpose of clarity, Applicant is suggested to amend the preamble of claims 1, 9 and 11-13 from “an oral film” to “an oral film composition”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4-6, 9 and 11-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 9 and 11-13 newly recite a concentration range of HIV/Anti-retroviral drug “in an amount of from 2% to 75% by weight, based on the total weight of the oral film”. The specification discloses that “HIV/Anti-retroviral drugs and its pharmaceutically acceptable salt thereof according to the invention are may be present in an amount of about 2% to about 75% by weight based on the total weight of the composition” (page 7, lines 23-25; page 11, lines 20-25). The added material which is “based on the total weight of the oral film” is not supported by the specification.
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 1, 4-6, 9 and 11-16 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.
Claims 1, 9, and 11–13 recite a concentration range of the HIV/anti-retroviral drug as “an amount of from 2% to 75% by weight, based on the total weight of the oral film.” The specification discloses that “HIV/anti-retroviral drugs and pharmaceutically acceptable salts thereof according to the invention may be present in an amount of about 2% to about 75% by weight based on the total weight of the composition” (see page 7, lines 23–25; page 11, lines 20–25). Throughout the specification, the recited concentration range appears to be calculated based on the total weight of the composition, rather than the total weight of the oral film. In addition, the specification indicates that the film material is applied as a coating to the HIV/anti-retroviral drug.
Accordingly, it is unclear whether the claimed concentration range is intended to be based on the total weight of the oral film composition. It is further unclear whether the film material itself contains the HIV/anti-retroviral drug before application to the core containing the HIV/anti-retroviral drug. Applicant is requested to clarify the scope of the claims.
Claims 4-6 and 14-16 are included in this rejection because they fail to remedy the indefiniteness issue under 112,2nd issue, and depend from the rejected base claims 1, 9 and 11-13.
For the examination purpose, it is understood that the amounts of the HIV/anti-retroviral drug” is based on the total weight of the oral film composition”.
103 rejection
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4-6, 9 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Malhotra et al. (WO 2014/064409 A1) in view of KR101940401B1 (English translation), and further in view of Barnhart et al. (US 9937123), if necessary further in view KR20160039050A (IDS filed 10/13/2025) or CN107714676A (IDS filed 10/13/2025)
Malhotra teaches a pharmaceutical composition comprises at least one integrase inhibitor selected from “dolutegravir, elvitegravir, MK-2048, JTK-656, raltegravir” and at least one antiretroviral or anti-HIV agent selected from “zidovudine, didanosine, stavudine, lamivudine, abacavir, adefovir, lobucavir, entecavir, apricitabine, emtricitabine, et…” (abstract; entire; page 8, para. 1 through page 10, para 2). Various combinations are taught as preferred embodiment as following: 1) dolutegravir, tenofovir and emtricitabine/lamivudine combination, 2) elvitegravir, tenofovir and lamivudine combination, 3) elvitegravir, tenofovir and emtricitabine combination, 4) dolutegravir, lamivudine and zidovudine combination, 3) dolutegravir, emtricitabine and lamivudine/zidovudine, 5) dolutegravir, abacavir and lamivudine combination etc.… with one or more pharmaceutically acceptable excipients including carriers, diluents or fillers, binders, lubricants, glidants and disintegrants (page 10, last paragraph through page 12, para. 3; page 14, para. 4-5; Examples), wherein said composition are prepared in various dosage forms including oral or buccal administration, e.g., tablet, granules, pills, beads, etc. … (page 7, para. 6 bridging para. In page 8; page 12, para. 4 through page 15, para. 4). Malhortra teaches that the dose of dolutegravir is in the range of 1 to 50mg, preferably in the rage of 25 to 50mg; the dose of raltegravir is in the range of 25 to 500mg, for example 25, 100, 400, 500mg; the dose of elvitegravir is in the range of 1 to 200mg, preferably in the range of 25 to 180mg (page 8, para. 3-7). In addition, Malhortra teaches the pharmaceutical composition according the present invention may also be coated i.e., seal coated or film coated, using polymeric materials such as HPMC, hydroxypropyl cellulose, polyvinylpyrrolidone, methylcellulose, carboxymethylcellulose, Hypromellose, acacia, gelatin and polyvinyl alcohol-polyethylene glycol copolymer and polyvinyl alcohol and the like or combination thereof (page 18, para. 2-4). Malhortra further teaches that the composition may be formulated with plasticizers selected from “polysorbates such as sorbitan monolaurate (SPAN 20), sorbitan monopalmitate, sorbitan monostearate, sorbitan monoisostearate, triethyl citrate, citrate phthalate, propylene glycol, glycerin, polyethylene glycol, etc.…” (page 16, para. 7 through page 17, para. 1). Additionally, Malhortra teaches that the pharmaceutical composition may include additional excipients such as carriers, diluents or fillers, binders, lubricants, glidants, disintegrants, bulking agent, flavorants, colourants, sweetners (e.g., sucrose, fructose, maltose… and their derivatives and the like), preservatives, viscosity enhancing/thickening agents, etc.… (page 14, para. 6 through page 19, para. 1); and that “non-limiting examples of suitable pharmaceutically acceptable carriers, diluents or fillers for use in the pharmaceutical include…maltodextrin…starches or modified starches (including potato starch, corn starch, maize starch and rice starch)…” (page 14, para. 6). As specific embodiment of the invention, Malhortra discloses various film coated HIV/anti-retroviral combination composition. For example, Example 7 discloses amount of dolutegravir+emitricitabine+Tenofovir disoproxil fumerate in total composition (about 52%); Example 8 discloses amounts of dolutegravir+tenofovir+lamivudine in the total composition (about 55%); and Example 9 discloses amounts of dolutegravir+lamivudine+zidovudine in the total composition (about 49%).
KR101940401B1 teaches taste-masked disintegrating films and preparations methods (entire document; para. [0001]) where the oral disintegration film (ODF) formulation can be formulated with lipids; film-forming polymers selected from “pullulan, gelatin, pectin, low viscosity pectin, hydroxypropylmethylcellulose, low viscosity hydroxypropylmethylcellulose, hydroxyethylcellulose, hydroxypropylmethylcellulose cellulose, carboxymethylcellulose, polyvinyl alcohol, polyacrylic acid, methyl methacrylate copolymer, carboxyvinyl polymer, polyethylene glycol, alginic acid, low viscosity alginic acid, sodium alginate, carrageenan, modified starch, casein, the water-soluble polymer may be at least one water-soluble polymer selected from the group consisting of water, a water-soluble polymer, a water-soluble polymer, a separation product, jane, levan, elscan, gluten, acacia gum, carrageenan, gum arabic, guar gum, locust bean gum, xanthan gum…”; plasticizer including glycerin fatty acid ester, sucrose fatty acid ester, lecithin, enzyme-treated lecithin, polysorbate, sorbitan fatty acid ester, sorbitol, maltitol, xylitol, glycerin, polyethylene glycol, propylene glycol, starch syrup, glycerin, triacetin, glycerol oleate, triethyl citrate, and a medium chain fatty acid…”; and the additives such as a sweeteners (e.g., sucralose), a flavor, a stabilizer, a pH adjuster and flavors (para. [0072]-[0082]). KR101940401B1 teaches the suitable active drug for the oral disintegration film formulation selected from “entecavir, lamivudine, abacavir, atazanavir, zidovudine, cobicistat, stavudine, didanosine, dolutegravir, darunavir, efavirenz, etravirine, elvitegravir, emtricitabine, fosamprenavir, indinavir, indinavir, lopinavir…nevirapine, raltegravir, ritonavir, rilpivirine, tenofovir, tipranavir, saquinavir, or a salt thereof” (para. [0067], [0135]). KR101940401B1 discloses that the claimed ODF formulation is a mount rinse film preparation wherein “the oral disintegration film is a drug-loaded formulation in thin film formulations, and the oral disintegrating film formulation provides several advantages over conventional solid dosage forms, liquids, and oral disintegrating tablets. That is, since the oral disintegrating film preparation can be taken without water, it is very useful not only for the elderly who have difficulties in taking tablets or capsules but also for children, persons with disabilities, patients lying in bed, busy modern people, It is estimated that disintegration is more advanced than any existing formulations. Particularly, when the drug is absorbed into the buccal mucosa, the first pass of the liver can be avoided. Therefore, the buccal disintegration film has an advantage that it can be applied to drugs which are highly metabolized among the drugs absorbed from the digestive tract. Therefore, many efforts have been made to manufacture oral disintegrating film formulations of various techniques for the physical properties of film and patient compliance” (para. [0006]). Also, KR101940401B1 discloses that the oral disintegrating film formulation further improve the taste shielding effect (para. [0070]-[0072]; [0086]-[0089]; [0107]- [0111]).
Barnhart et al. is cited as a reference to establish that, at the time the invention was made, oral dissolvable/disintegrating films with thicknesses of approximately 20 to 300 microns that disintegrate within about three minutes upon contact with saliva were well known. Barnhart teaches a dissolvable or disintegratable film for delivering a pharmaceutical agent where the oral film formulation is prepared with mixture of film form polymers (e.g., hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, poly(ethylene) oxide, etc…) in the range of about 2% to about 35% for each polymer based on the total weight of the dry film (or in the range of about 2% to about 80% for a low molecular polymer and/or in the rage of about 5% to about 10% for the high molecular polymer), filler, plasticizer (e.g., polyaocohols, sorbitan esters, polyethylene glycol, polyethylene oxide, polyvinyl alcohol, triacetin, glycerin, etc...) in the range of 3% to 30%, 10% to 20%, or 15% to 18% by weight of the dry film, humectant and other excipients such as flavors, sweeteners (e.g., sucralose), colorants, etc.. (entire document; abstract; col. 2, lines 23-38; col. 3, line 40 through col. 4, line 32; col. 6, lines 27-48; col. 6, line 49 through col. 7, line 36; examples; claims 1-19). Barnhart also teaches that the film having thickness in the range of about 20 microns to about 1200 microns, more preferably less than about 250 microns or equal to or less than 200 microns or less than about 175 microns or less than about 75 microns rapidly disintegrate to release the active without causing any undue discomfort to the oral cavity (col. 8, lines 23-36); the oral film is disintegrated in the oral cavity within about 20 to 60 seconds after contact with a mucous membrane (col. 2, lines 49-54; col. 42-44; col. 8, lines 57-67; claim 9); the optional glucose component of thin film (e.g., maltodextrin) can be added as a sweetner and/or to promote rapid disintegration of the film in the range of about 2% to 20% or about 3% to about 15% (col. 5, lines 43-67; Examples); and that the optional starch component of films can be added to promote rapid disintergration of the film and/or to aid in film formation in the range of about 2% to 50% or about 3% to about 35% by weight based on the dry film (col. 6, lines 1-26).
KR 20160039050 A or CN107714676A ( IDS filed 10/13/2025) is cited as extrinsic evidence to demonstrate the routine dosage of entecavir in oral delivery form, namely 0.5mg to 1.0mg per day or in the range of 0.001 to 30% or 0.05-15 by weight of the oral composition.
Regarding the instantly claims 1, 4-6, 9 and 11-16, even though Malhotra teaches all the elements of the current invention, i) the reference(s) does/do not expressly name the HIV/anti-retroviral drug or drugs in combination with at least one film forming polymer and at least one plasticizer and optionally with excipients, furthermore ii) the reference does/do not teach the specific characteristic of the formulation having “disintegrates within about three minutes upon contact with saliva, the oral film has thickness of from 20 microns to about 300 microns”, and “does not adhere to the mucosal surfaces of the buccal cavity as an intact film or disintegrated residue”; and that the specific combination of the HIV/anti-retroviral drug or drugs in combination with at least one film forming polymer comprises Hypromellose and optionally starch and/or povidone in an amount of 1 to about 60% by weight, at least one plasticizer comprises glycerine in an amount of 1 to about 30% by weight and sucralose, and/or a suspending agent comprises maltodextrin in an amount of about 1 to about 50% by weight.
However, KR101940401B1 teaches the advantage of formulating antiviral drugs such as entecavir, lamivudine, abacavir, atazanavir, zidovudine, cobicistat, stavudine, didanosine, dolutegravir, darunavir, efavirenz, etravirine, elvitegravir, emtricitabine, fosamprenavir, indinavir, lopinavir, nevirapine, raltegravir, ritonavir, rilpivirine, tenofovir, tipranavir, saquinavir, or a salt thereof into an oral disintegrating film (ODF) to mask unpleasant taste and to improve patient compliance, especially children, persons with disabilities, patients lying in bed or busy modern people . Given this teaching, it would have been obvious to a person of ordinary skill in the art to incorporate one or more known HIV/antiretroviral agents disclosed in KR101940401B1 together with typical ODF components (e.g., film-forming polymer, plasticizer, and other excipients) to produce an ODF formulation that shields the drug’s raw taste. Malhotra’s disclosure would have provided additional motivation and guidance to modify its formulation teachings by combining the known antiretroviral drug(s) with film-forming polymers, plasticizers, and excipients to achieve an oral disintegrating film that masks unpleasant taste and provide advantages over conventional oral dosage forms.
Consistent with this reasoning, it would have been obvious to have selected various combinations of disclosed ingredients (including the selection of from specific film polymer and plasticizer and/or excipients listed in claim 4-6, respectively, within the prior art disclosure of the Malhortra and the KR101940401B1 ), to arrive at the instantly claimed combination “yielding no more than one would have expected from such an arrangement”. From the prior art teaching alone or in combination, one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention since the prior art makes obvious that the film-forming polymer and one or more excipients including plasticizer, fillers/bulking agents, flavoring agents, coloring agents, surfactants and stabilizers have been routinely utilized in making film-coated tablet containing HIV/anti-retroviral drug or HIV/anti-retroviral drugs in combination with integrase inhibitor(s).
It must be remembered that “[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 step1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Regarding the specific disintegrating characteristic of said oral film formulation recited in claims 1, 9 and 11-13, namely “the oral film disintegrates within about three minutes upon contact with saliva, the oral film has thickness of from 20 microns to about 300 microns”, “does not adhere to the mucosal surfaces of the buccal cavity as an intact film or disintegrated residue” and/or “disintegrates upon contact with aqueous media or saliva in the oral cavity within sixty seconds”, Barnhart teaches that the design of dissolvable/disintegrating films within thicknesses of approximately 20 to 300 microns that disintegrate within about three minutes upon contact with saliva were well known at the time of the invention was made. One having ordinary skill in the art would have understood in light of the cited prior art in combination that delivering of the HIV/retroviral drugs in oral dissolvable/disintergrated film formulation provides advantage of not only convenience to certain patient population (e.g., children, persons with disabilities, patients lying bed, busy modern people but also taste making effects by rapidly disintegrates in oral or buccal mucous membrane by saliva or other aqueous materials on the mucosal surface within about 20 to 60 seconds when the thickness of film is designed within about 20 microns to about 1200 microns, most preferably less than about 75 microns. Thus, one having ordinary skill in the art would have motivated to do so with reasonable expectation of success to arrive at the claimed invention.
Regarding the specific amounts of HIV/anti-retroviral agent, as discussed above, Malhotra teaches amounts of about 24-28% of various HIV/anti-retroviral agent(s) alone or in combination based on the total weight of the composition. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists, thus addressing the specific thickness and the specific disintegrating time. Further, the amounts or concentration ranges are interpreted broadly considering the Applicant’s use of “about.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). MPEP 2144.05 (1). Alternatively, the selection of any particular dose or quantity of HIV/antiretroviral drug(s) is considered no more than optimization of a result-effective parameter via routine experimentation, and considered obvious thereby. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that 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 specific characteristic of the oral film formulation recited in claims 1, 9, and 11–13—namely, that the oral film composition having “does not adhere to the mucosal surfaces of the buccal cavity as an intact film or disintegrated residue””—the Examiner interprets this characteristic or property as to mean that any adherence to the mucosal surfaces of the oral or buccal cavity is transient and lasts less than about three minutes. In other words, the film does not adhere to a large extent to the mucosal surface of the oral or buccal cavity since it is disintegrated within about three minutes upon contact with . Although Barnhart describes its oral film as “mucoadhesive,” the reference teaches the use of the same film-forming polymers with other ingredients recited in the instant claims and discloses that the film rapidly disintegrates within about 20 to 60 seconds upon contact with a mucous membrane. Accordingly, the Examiner determines that the prior art teaching meets the claimed non-mucoadhesive limitation.
Regarding the specific components and amounts of each components recited in claims 15-16, particularly i) the specific amounts of film forming polymer such as hypromellose (which is known as hydroxypropyl methylcellulose or HPMC), optionally with starch and povidone (which is known as polyvinyl pyrrolidone), ii) the specific amounts of plasticizer such as glycerin, iii) the specific amounts of suspending agent such as maltodextrin and iv) sucralose in said composition.
As discussed above, KR101940401B1 and Barnhart et al. make clear that film forming polymer such as hypromellose and povidone, plasticizer such as glycerin and excipients such as maltodextrin, sucralose and starch are well components that are routinely incorporated in oral disintegration film (ODF) formulation. Thus , it would have been obvious to have selected various combinations of disclosed ingredients (including the selection of from specific film polymer and plasticizer and/or excipients listed in claims 15-16, within the prior art disclosure of the Malhortra, KR101940401B1 and Barnhardt et al.), to arrive at the instantly claimed combination “yielding no more than one would have expected from such an arrangement”.
It must be remembered that “[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 step1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Regarding the specific amounts of each ingredients recited in claims 15 and 16, Barnhardt et al. teaches or suggests the range of about 2% to about 35% for each polymer (e.g., hydroxypropyl methylcellulose, polyvinyl pyrrolidone) based on the total weight of the dry film (or in the range of about 2% to about 80% for a low molecular polymer and/or in the rage of about 5% to about 10% for the high molecular polymer); the range of 3% to 30%, 10% to 20%, or 15% to 18% of the plasticizer (e.g., glycerine); the range of about 2% to 20% or about 3% to about 15% of maltodextrin; and the range of about 2% to 50% or about 3% to about 35% of starch. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists, thus addressing the concentration of each components recited in claims 15 and 16. Alternatively, the selection of specific quantity of known polymer(s(), plasticizer and excipients in formulating oral disintegration film (ODF) formulation is considered no more than optimization of a result-effective parameter via routine experimentation, and considered obvious thereby. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that 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).
In light of the forgoing discussion, it is determined that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
Response to Arguments
Applicant's arguments filed 05/06/2026 have been fully considered but they not found persuasive as followings:
Applicant’s arguments that there is no teaching, suggestion, or motivation to make the claimed film formulation is not persuasive. As discussed above, KR101940401B1 and Barnhart provide the relevant nexus and motivation. KR101940401B1 teaches oral disintegrating films and highlights the advantages of converting active drugs into an ODF format—advantages that include masking unpleasant taste and improving patient convenience for the elderly with swallowing difficulties, children, persons with disabilities, bedridden patients, and other users who prefer or require a non-swallow dosage form. Barnhart further teaches the preparation of ODFs, including film thicknesses in the range of about 20 microns to about 1200 microns (most preferably less than about 75 microns), and that such films rapidly disintegrate to release the active ingredient—about 20 to 60 seconds after contact with a mucous membrane—without causing undue discomfort to the oral cavity. These teachings demonstrate that the claimed disintegration time and thickness were well known at the time the invention was made and would have motivated a person of ordinary skill in the art to modify Malhotra accordingly. Furthermore, KR101940401B1 and Barnhart et al. make clear that film forming polymer such as hydroxypropyl methylcellulose (hypromellose) and polyvinyl pyrrolidone (povidone), the plasticizer such as glycerin and excipients such as maltodextrin, sucralose and starch are well known components that are routinely incorporated in oral disintegration film (ODF) formulation. Thus, it would have been obvious to have selected various combinations of disclosed ingredients (including the selection of from specific film polymer and plasticizer and/or excipients listed in claims 15-16, within the prior art disclosure of the Malhortra, KR101940401B1 and Barnhardt et al.), to arrive at the instantly claimed combination “yielding no more than one would have expected from such an arrangement”.
Applicants’ argument takes the position that Malhotra, KR101940401, Barnhart alone or in combination does not disclose the oral film of Dolutegravir, abacavir and Lamivudine combination, Abacavir, Doutegravir and Lamivudine combination or emitricitabine and tenofovir combination in an amount of from 2% to 75% by weight. As discussed above, Malhotra not only discloses various embodiments of HIV/anti-retroviral agent or in combination including dolutegravir, emitricitabine and lamivudine combination, dolutegravir and tenofovir combination, dolutegravir, abacavir and lamivudine combination, dolutegravir, abacavir and emitricitabine combination, but also the amounts of specific HIV/antiretroviral agent in the formulation. For example, Example 9 shows about 4.9% of dolutegravir (50mg) alone or about 49% of mixture of dolutegravir (50mg), lamivudine (150mg) and Zidovudine (300mg) based on 1025mg of the final coated tablet weight ; about 4.2% of dolutegravir (50mg) alone or about 55% of mixture of dolutegravir (50mg), tenofovir (300mg) and lamivudine (300mg) based on 1180mg of final coated tablet weight (Example 8); and about 4.7% of dolutegravir (50mg) alone or about 52% of dolutegravir (50mg), emitricitabine (200mg) and tenofovir (300mg) combination based on 1055mg final coated tablet weight.
HIV/anti-retroviral agent the specific amounts of HIV/anti-retroviral agent(s), Malhotra teaches amounts of about 24-28% of various HIV/anti-retroviral agent(s) alone or in combination based on the total weight of the composition. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists, thus addressing the specific thickness and the specific disintegrating time. Further, the amounts or concentration ranges are interpreted broadly considering the Applicant’s use of “about.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). MPEP 2144.05 (1). Alternatively, the selection of any particular dose or quantity of HIV/antiretroviral drug(s) is considered no more than optimization of a result-effective parameter via routine experimentation, and considered obvious thereby. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that 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.).
The cited prior art expressly provides a finite number of identified, predictable options for achieving the claimed objective. Where the prior art discloses a limited number of know alternatives, selection of one of those alternatives amounts to routine optimization within the level of one of ordinary skill in the art (see MPEP 2143 – Obvious to try when a finite number of identified, predictable solutions are found in the prior art). A person of ordinary skill in the art would have been motivated to pursue these known options with a reasonable expectation of success particular when each of the alternatives is taught as suitable for the same purposes (see MPEP 2143 and MPEP 2144.06). The claimed selection, therefore, represents no more than the predictable use of prior art elements according to their established functions, and does not confer patentable distinction (see MPEP 2143; KSR Int’l Co v Teleflex Inc).
In light of the forgoing discussion, it is determined that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian-Yong Kwon whose telephone number is (571)272-0581. The examiner can normally be reached usually except 2nd Friday (6-9am); Tues-Thurs 6am-3pm except Mon, Fri 6am-4:00pm 2nd Thurs 6am-12 noon.
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.
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.
/BRIAN-YONG S KWON/ Supervisory Patent Examiner, Art Unit 1613
Prosecution Insights