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 .
Election/Restrictions
Applicant’s election of Group III, with the addition of HPC-M, HPC-G, PEG-400, ethanol, and water, as the composition species, in the reply filed on 10/30/2024 is acknowledged and maintained.
Priority
This application is a national stage filing under 35 U.S.C. § 371 of International PCT
Application PCT/PT2020/050009, filed February 18, 2020, which claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application, U.S.S.N. 62/807,680, filed on February 19, 2019.
Claims Status
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on October 10, 2025. Claims 57, 109-113, and 115-133 are pending. Claims 1-56, 58-108, and 114 are canceled. Claims 111-113, 123-126, and 128-129 are withdrawn. Claims 57, 109, 110, 115-122, 127, and 130-133 are examined in accordance to the elected species.
Action Summary
Claims 57, 109, 110, 115-122, 127, and 130-132 rejected under 35 U.S.C. 103 as being unpatentable over Krekeler et al (US2013/0216594 A1) in view of Ashland (Klucel hydroxypropyl cellulose, 2017, pages 1-24), Wang et al (WO2018/004576 A2), and Lockwood et al (US10,946,169 B2), are maintained, but revisited and modified in light of claim amendment and the addition of claim 133.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 57, 109, 110, 115-122, 127, and 130-133 are rejected under 35 U.S.C. 103 as being unpatentable over Krekeler et al (US2013/0216594 A1) in view of Ashland (Klucel hydroxypropyl cellulose, 2017, pages 1-24), Wang et al (WO2018/004576 A2), and Lockwood et al (US10,946,169 B2).
Krekeler teaches a pharmaceutical composition for oral administration comprising the steps of:
(i) forming a Suspension of at least one pharmaceutical ingredient (A) and a solvent or a solvent mixture (B), wherein the at least one pharmaceutical ingredient (A) is poorly soluble or insoluble in the solvent or solvent mixture (B),
(ii) adding at least one gel former (C) to the Suspension, wherein the at least one gel former (C) is swellable in the solvent or solvent mixture (B) and, optionally
(iii) allowing the Suspension to Swell. (See claim 1.) The absence teaching of polyvinyl pyrrolidone copolymer in Krekeler implies the inclusion of 0% by weight. That means the 0% by weight of polyvinylpyrrolidone is construed to be absent. Moreover, Krekeler teaches the at least one pharmaceutical ingredient (A) is between 10% and 80% by weight, and the gel former (C) is between 5% and 25% by weight, each related to the dry weight of the composition. (See claim 5.) Additionally, Krekeler teaches at least two solvents, wherein the proportion of solvent in the mixture is between 50% (v/v) to 100% (v/v) respectively 0% (v/v) to 50% (v/v). (See claim 7.) Krekeler teaches the pharmaceutical ingredient (A) is readily soluble in an aqueous solvent system or aqueous solvent systems, or mixtures thereof, and the solvent or solvent mixture (B) is selected from C1-C5 alkanols, acetone or mixtures thereof. (See claim 8.) Krekeler also teaches the gel former (C) is selected from the group consisting of hydroxypropyl cellulose, hydroxypropyl methyl cellu lose, methyl cellulose, Klucel(R), Klucel(R) E. Klucel(R) L, Klucel(R) J. Klucel® G, Klucel® M. Klucel(R) H, Klucel® EF, Klucel® LF, Klucel® JF, Klucel® GF, Klucel® MF, Klucel® HF, Klucel® EX, Klucel® LXF, Klucel® JXF, Klucel® GXF, Klucel® MXF, Klucel® HXF, ethyl cellulose or mixtures thereof. (See claim 10.) Krekeler teaches in the methods known to date for the formation of corresponding compositions in particular in the form of orodispersible films, that suggest the use of water as a solvent for a water-soluble active substance to be formulated, the maximum attainable proportion of active compound in the composition or in the film, especially of the aforesaid drugs sumatriptan succinate or sildenafil citrate is at most 10 wt %. (See paragraph [0090].) At most 10 wt% is construed to be less than or equal to 10 wt% which contemplates the 0.1-5% by weight claimed in claim 133. Krekeler the pharmaceutical composition further comprising a plasticizer which can be between 2-15% by weight. (See claims 3 and 6.) Furthermore, Krekeler teaches the ingredient to be formulated is insoluble or poorly soluble in an aqueous solvent (system). In this case the solvent or solvent mixture (B), respectively, is an aqueous solvent or solvent mixture, respectively, preferably water. (See paragraph [0071].) Lastly, Krekeler teaches If the ingredient to be formulated is a highly water-soluble ingredient, in the present invention solvent or solvent mixtures (B) are preferably used as solvent or solvent mixtures (B) which are selected from C1- to C5-alkanols and herein in particular, organic solvents, for example ethanol or isopropanol or acetone. Of course, mixtures of the aforementioned C1- to C5-alkanols. (See paragraph [0070].)
Krekeler does not specifically teach HPC-M is between 0.3% and 4%, inclusive, HPC-G is between 0.6% and 3.5%, inclusive, ethanol is between 10% and 80%, inclusive, and water is between 20% and 75%, inclusive, by weight, provided the total concentration of all components is 100% inclusive, by weight. Moreover, Krekeler does not teach PEG-400 in the amount of 0.1-8.0% by weight and specifically 0.1-5% by weight of active agent.
Ashland teaches water, methanol, and ethanol function as excellent cosolvents and, in many cases, are effective in relatively small quantities (5% to 15%). (See right column of page 8.) Moreover, Ashland teaches the viscosity of HPC-M is around 100,000 cps (mPas) at 2.5- 3% by weight and the viscosity of HPC-G is around 1,000-40,400 cps (mPas) is at 2.5- 6% by weight and around 500 mPas in ethanol: water and 6,640 mPas in propylene glycol at 2%. (See page 9, Figure 4 and Table 4.) Ashland further teaches blends of Klucel HPC and other cellulosic polymers have been used to improve wet granulation characteristics and tableting characteristics, as well as to achieve better control and manipulation of the rate of drug release. (See page 17, right column.)
Wang teaches a fast acting orally disintegrating film (ODF) comprising: lidocaine free -base or a pharmaceutically acceptable salt thereof; at least one primary film-forming polymer;
at least one secondary film-forming polymer; and at least one plasticizer, wherein the primary film-forming polymer and the secondary film-forming polymer are present at a ratio of about 1: 1 to about 20: 1 by weight and wherein the primary film-forming polymer and the secondary film-forming polymer are hydrophilic. (See claim 1.) Moreover, Wang teaches plasticizers are an important component as they improve extensibility property of the ODF to provide flexibility to the ODF to minimize breakages that may occur under normal handling conditions including, but limiting to PEG 400. (See last paragraph of page 7.) Furthermore, Wang teaches the ODF may comprise a saliva stimulant. Saliva stimulants can be added to increase the rate of saliva production in order to promote a faster disintegration of the orodispersible film. (See second paragraph of page 11.)
It would have been prima facie obvious to one ordinary skill in the art at the time the invention was filed to replace the plasticizer taught by Krekeler with the plasticizer taught by Wang and further use HPC-M is between 2.5% and 3%, inclusive, HPC-G is between 2% and 6%, inclusive, ethanol is between 10% and 80%, inclusive, PEG-400 in the amount of 0.1-8% by weight inclusive, and water is between 8% and 75%, inclusive, by weight, provided the total concentration of all components is 100% inclusive, by weight to give Applicant’s claimed invention. One would have been motivated to do so, because Wang teaches PEG-400 is an excellent that can provide flexibility to the ODF to minimize breakages that may occur under normal handling conditions, Krekeler teaches at least one pharmaceutical ingredient (A) is between 10% and 80% by weight, and the gel former (C), which can be a mixture of HPC including HPC-M and HPC-G is between 5% and 25% by weight, at least two solvents, wherein the proportion of solvent in the mixture is between 50% (v/v) to 100% (v/v) respectively 0% (v/v) to 50% (v/v) and water as one of the preferred solvents and also teaches the pharmaceutical composition further comprising a plasticizer which can be between 2-15% by weight, also because HPC-M in the amount of 2.5-3% by weight and HPC-G in the amount of 2-6% exhibits great viscosity as taught by Krekeler If 50% ethanol is used then the other 50% can be water. One would reasonably expect the modified composition to be effective for preparing an orodispersible film.
With respect to claim 133. One would have been able to find it prima facie obvious as well to include the amount of the active between 0.1-5% by weight to give an orodispersible film that includes water to give Applicant’s claimed invention. One would have been motivated by the fact that Krekeler teaches in the methods known to date for the formation of corresponding compositions in particular in the form of orodispersible films, that suggest the use of water as a solvent for a water-soluble active substance to be formulated, the maximum attainable proportion of active compound in the composition or in the film, especially of the aforesaid drugs sumatriptan succinate or sildenafil citrate is at most 10 wt %. (See paragraph [0090].) At most 10 wt% is construed to be less than or equal to 10 wt% which contemplates the 0.1-5% by weight claimed in claim 133. One would reasonably expect the inclusion of the amount of 0.1-5% by weight of an active ingredient to provide an effective orodisopersible film formulation with success.
With respect to claim 110, the combination of Krekeler and Ashland do not teach the claimed Kit.
However, Lockwood teaches a patient aid for ensuring proper dissemination of information relating to medical procedures, and in one or more embodiments, to a patient aid suitable for inclusion in a medical kit used for medical procedures that ensures the information is delivered to the patient undergoing the procedure. (See column 1, lines 33-38.) Moreover, Lockwood teaches work to facilitate delivery of this information to the patient, thereby reducing hospital readmissions, improving patient satisfaction, promoting self-care and preventative healthcare, and improving patient compliance with medical instructions. (See column 4, lines 29-33.)
It would have further been prima facie obvious for a person of ordinary skill in the art at the time of the invention was filed to package the pharmaceutical composition taught by Krekeler and Ashland into a Kit with instruction to use the kit. One would have been motivated to do so, because Lockwood teaches a kit for instruction to use the kit provides for facilitating delivery of the information to the patient, thereby reducing hospital readmissions, improving patient satisfaction, promoting self-care and preventative healthcare, and improving patient compliance with medical instructions. One would reasonably expect the kit to reduce hospital readmissions, improve patient satisfaction, promote self-care and preventative healthcare, and improve patient compliance with the medical instructions.
Acknowledgement is made of the receipt and entry of Applicant’s argument/remarks filed on October 10, 2025.
Applicant’s argument
Applicant argues that the concentration "between 5% and 25% by weight" disclosed in Krekeler is by dry weight of the composition. See, e.g., paragraph 0079 of Krekeler. The compositions of amended claim 57 are not dry compositions because the compositions comprise (ii) ethanol, a propanol, a butanol, or a mixture thereof; and (iii) water. Therefore, the concentrations of hydroxypropyl cellulose M ("HPC M") and hydroxypropyl cellulose G ("HPC G") by weight recited in amended claim 57 are not by dry weight of the compositions. Therefore, the concentration by dry weight disclosed in Krekeler would not have been probative. Krekeler discloses that "[t]he gel former (C) may be ... Klucel® LF ...." Paragraph 0029 of Krekeler. Krekeler suggests the concentrations of Klucel® LF being 8.6% and 7.9%, respectively, by weight (see, e.g., Examples 1 and 2 of Krekeler). One of ordinary skill in the art would have understood that the concentration of 8.6% by weight could be calculated from the expression: 20/(65+6.8+0.2+4+4+20+93.6+40.1). See Example 1 of Krekeler. One of ordinary skill in the art would also have understood that the concentration of 7.9% by weight could be calculated from the expression: 19/(65+6.8+0.2+4+5+19+98.8+42.3). See Example 2 of Krekeler. The concentrations of 8.6% and 7.9% by weight are significantly higher than the concentration of HPC M of between 0.3% and 4% by weight and the concentration of HPC G of between 0.6% and 3.5% by weight recited in amended claim 57. Krekeler does not teach or suggest a reason to significantly decrease the concentration of 8.6% or 7.9% by weight to arrive at a concentration of HPC M or HPC G by weight recited in amended claim 57.
Examiner’s response
In response, Applicant’s argument is not persuasive. It may well be true that the concentration "between 5% and 25% by weight" disclosed in Krekeler is by dry weight of the composition. However, Krekeler teaches the use of water as a solvent for a water-soluble active substance to be formulated, the maximum attainable proportion of active compound in the composition or in the film, especially of the aforesaid drugs sumatriptan succinate or sildenafil citrate is at most 10 wt %. (See paragraph [0090].) Furthermore, Krekeler teaches the ingredient to be formulated is insoluble or poorly soluble in an aqueous solvent (system). In this case the solvent or solvent mixture (B), respectively, is an aqueous solvent or solvent mixture, respectively, preferably water. (See paragraph [0071].) Lastly, Krekeler teaches If the ingredient to be formulated is a highly water-soluble ingredient, in the present invention solvent or solvent mixtures (B) are preferably used as solvent or solvent mixtures (B) which are selected from C1- to C5-alkanols and herein in particular, organic solvents, for example ethanol or isopropanol or acetone. Of course, mixtures of the aforementioned C1- to C5-alkanols. (See paragraph [0070].) Therefore, a person of ordinary skill in the art can reasonably figure out the percentage in weight percent after the addition of the solvent starting with the 5-25 by dry weight. For example, in example 2 of Krekeler, 16 g of Klucel ® LF was used in a 100 g dry weight and 141.1 g of solvent, the 19 g amounts to 7.9% by weight (19g / 141.1 g of total ingredient). However, if 5 g (5% dry weight) of Klucel® LF was used, then 5 g / 141.1 g would be equal to 3.5% by weight. Moreover, Krekeler may not teach or suggest a reason to significantly decrease the concentration of 8.6% or 7.9% recited in examples 1 and 2 respectively. However, Krekeler clearly teaches the pharmaceutical ingredient (A) may be a phar maceutically active ingredient or a mixture comprising at least one pharmaceutically active ingredient and the at least one pharmaceutical ingredient (A) may comprise between 10 wt % and 80 wt %, preferably between 50 wt % and 70 wt %, and the gel former (C) may comprise between 5 wt % and 25 wt %, preferably 7.5 wt % each based on the dry weight of the composition. Emphasis is giving on the 7.5 dry weight%. (See paragraph [0022].) Additionally, Ashland teaches water, methanol, and ethanol function as excellent cosolvents and, in many cases, are effective in relatively small quantities (5% to 15%). (See right column of page 8.) Moreover, Ashland teaches the viscosity of HPC-M is around 100,000 cps (mPas) at 2.5- 3% by weight and the viscosity of HPC-G is around 1,000-40,400 cps (mPas) is at 2.5- 6% by weight and around 500 mPas in ethanol: water and 6,640 mPas in propylene glycol at 2%. (See page 9, Figure 4 and Table 4.) Ashland further teaches blends of Klucel HPC and other cellulosic polymers have been used to improve wet granulation characteristics and tableting characteristics, as well as to achieve better control and manipulation of the rate of drug release. (See page 17, right column.) In fact, Ashland teaches HPC-M and HPC-G are used in aqueous organic solvent at low concentration around 2-6% by weight. Therefore, a person of ordinary skill in the art would reasonably expect using a low concentration of HPC-M and HPC-G in order to provide an orodispersible film with faster disintegration.
Applicant’s argument
Applicant argues that the pharmaceutical compositions disclosed in Krekeler also significantly differ from the compositions of amended claim 57 with respect to the concentration of water. Krekeler discloses that "the water content of the pharmaceutical composition may be less than 0.5% by weight ...," (paragraph 0050 of Krekeler), which is significantly lower than the concentration of water of between 20% and 75% by weight recited in amended claim 57. Moreover, the pharmaceutical compositions of Examples 1 and 2 of Krekeler did not include water at all. Krekeler does not teach or suggest a reason to significantly increase the concentration of water of less than 0.5% by weight to arrive at a concentration of water by weight recited in amended claim 57. Therefore, amended claim 57 would not have been obvious over Krekeler.
Examiner’s response
In response, Applicant’s argument is not persuasive. The Examiner does not dispute the fact that some embodiment of Krekeler discloses that "the water content of the pharmaceutical composition may be less than 0.5% by weight ...," (paragraph 0050 of Krekeler). However, other embodiment of Krekeler teaches the ingredient to be formulated is insoluble or poorly soluble in an aqueous solvent (system). In this case the solvent or solvent mixture (B), respectively, is an aqueous solvent or solvent mixture, respectively, preferably water. In each case, a solvent respectively solvent mixture is used, in which the ingredient to be formulated or the active ingredient, respectively, is insoluble or poorly soluble. It can thus be achieved that during the process of preparing the composition and in this case in particular in the formation of an orodispersible film the ingredient/active ingredient, does not dissolve in the solvent and is instead available in a dispersed form. This prevents that the ingredient to be formulated in a possible drying of the composition forms a concentrated salt solution that cannot be dried any more. Moreover, it is prevented that during drying of the composition non-uniform islands of active ingredient form in the composition, such that no homogeneous distribution of the active substance within the composition, for example over the entire orodispersible film is given. (See paragraphs [0071] – [0073].) Moreover, Krekeler teaches the method can produce advantageously a film with a wet film thickness of 400 to 600 µm, preferably of 460 to 490 µm. The film can then preferably have a dry film thickness of 100 to 200 µm, preferably of 140 to 180 µm. Of course, the thickness of the film can also be defined through the dry film thickness, in which case the wet layer thickness is extraneous. The dry film thicknesses preferably provided are between 100 and 200 µm, preferably of between 140 and 180 µm. A dry film thickness within the mentioned limits ensures rapid disintegration of the film within the oral cavity. (See paragraph [0100].) Krekeler teaches the use of water as a solvent for a water-soluble active substance to be formulated, the maximum attainable proportion of active compound in the composition or in the film, especially of the aforesaid drugs sumatriptan succinate or sildenafil citrate is at most 10 wt %. (See paragraph [0090].) Furthermore, Krekeler teaches the ingredient to be formulated is insoluble or poorly soluble in an aqueous solvent (system). In this case the solvent or solvent mixture (B), respectively, is an aqueous solvent or solvent mixture, respectively, preferably water. (See paragraph [0071].) Therefore, a person of ordinary skill in the art reading Krekeler can reasonably increase the concentration of water in the orodispersible film taught by Krekeler because the water concentration appears to depend on the solubility of the active agent. If the active agent is water-soluble, less water may be needed to get it properly dispersed. On the other hand, if the active agent is water-insoluble, more water may be needed or even additionally solubilizer to help disperse evenly.
Applicant’s argument
Applicant argues that Ashland would not have remedied the deficiencies of Krekeler. Although Figure 4 of Ashland provides concentrations lower than 4%, but that figure merely shows viscosity ranges for various grades of Klucel HPC, which does not teach or suggest using the Klucel HPC at any of the concentrations shown in that figure for pharmaceutical uses. On the contrary, Table 1 of Ashland provides that the concentration of GF Pharm and MF Pharm for typical pharmaceutical uses is 15%-35% by weight, significantly higher than the concentrations of HPC M and HPC G by weight recited in amended claim 57. Although page 17 of Ashland provides "Concentrations of 2- 6% w/w may be used as a binder in either wet-granulation or dry, direct-compression tableting processes," one of ordinary skill in the art would have understood this to refer to the first three rows of Table 1, which are not related to HPC M or HPC G. Therefore, Ashland does not teach or suggest a reason to significantly decrease the concentration of 8.6% or 7.9% by weight suggested in Krekeler to arrive at a concentration of HPC M or HPC G by weight recited in amended claim 57.
Examiner’s response
In response, Applicant’s argument is not persuasive. It may well be true that Ashland at Table 1 provides that the concentration of GF Pharm and MF Pharm for typical pharmaceutical uses is 15%-35% by weight, significantly higher than the concentrations of HPC M and HPC G by weight recited in amended claim 57 and concentrations of 2- 6% w/w may be used as a binder in either wet-granulation or dry, direct-compression tableting processes. However, Ashland teaches in oral products, Klucel HPC is primarily used as a film former or in tableting as a binder, film coating, and extended-release-matrix former. (See Section 5 of page 18.) Additionally, Ashland teaches Klucel HPV has excellent solubility in water and in polar organic solvent. Because Klucel HPC is used extensively to modify the viscosity of solutions, dispersions, emulsions, and suspensions involving water/organic solvents. The viscosity of aqueous solutions of klucel HPC increases rapidly with the concentrations with the concentration of klucel HPC-M ranges from 1-3 w% and HPC-G ranges from 1.8-6 wt% in water and organic solvent. (see Section 4.3.1 and 4.3.1.1 and Figure 4.) Furthermore, Krekeler teaches the method can produce advantageously a film with a wet film thickness of 400 to 600 µm, preferably of 460 to 490 µm. The film can then preferably have a dry film thickness of 100 to 200 µm, preferably of 140 to 180 µm. Of course, the thickness of the film can also be defined through the dry film thickness, in which case the wet layer thickness is extraneous. The dry film thicknesses preferably provided are between 100 and 200 µm, preferably of between 140 and 180 µm. A dry film thickness within the mentioned limits ensures rapid disintegration of the film within the oral cavity. (See paragraph [0100].) Therefore, on would reasonably expect the concentrations of klucel HPC-M at around 1-3% with a viscosity of 100-50,000 mPas and G at around 1.8 -6% with a viscosity of 100-30,000 mPas taught by Ashland and a wet film thickness of to five 400 to 600 µm as taught by Krekeler to give a thin film that can influence how quickly it dissolves in the mouth, because a higher viscosity typically means a thicker film, which can influence how quickly it dissolves in the mouth.
Applicant’s argument
Applicant argues that Ashland discloses that "[w]ater, methanol, and ethanol function as excellent cosolvents and, in many cases, are effective in relatively small quantities (5% to 15%)." Page 8, second column, first paragraph, of Ashland. This water concentration is significantly lower than the concentration of water of between 20% and 75% by weight recited in amended claim 57. Therefore, Ashland does not teach or suggest a reason to significantly increase the concentration of water of less than 0.5% by weight disclosed in Krekeler to arrive at a concentration of water by weight recited in amended claim 57. Therefore, amended claim 57 would not have been obvious over Krekeler in view of Ashland. Wang would not have remedied the deficiencies of Krekeler and Ashland. Wang does not teach or suggest any concentrations of any HPC by weight. Wang also does not teach or suggest a concentration of water of between 20% and 75% by weight. Therefore, amended claim 57 would not have been obvious over Krekeler in view of Ashland and Wang. One of ordinary skill in the art would not have had a reason to combine Lockwood with Krekeler, Ashland, and Wang for determining the obviousness or non-obviousness of amended claim 57. Lockwood discloses Foley catheter kits, whereas Krekeler and Wang disclose pharmaceutical compositions, and Ashland discloses excipients. One of ordinary skill in the art would have deemed Foley catheter kits to be significantly different from pharmaceutical compositions and excipients.
Examiner’s response
In response, Applicant’s argument is not persuasive. It may well be true that Ashland does not teach or suggest a reason to significantly increase the concentration of water of less than 0.5% by weight disclosed in Krekeler. It may also well be true that Wang does not teach or suggest any concentrations of any HPC by weight. Wang also does not teach or suggest a concentration of water of between 20% and 75% by weight. However, one would reasonably expect the modified composition to be effective for preparing an orodispersible film, because Wang teaches PEG-400 is an excellent that can provide flexibility to the ODF to minimize breakages that may occur under normal handling conditions, Krekeler teaches at least one pharmaceutical ingredient (A) is between 10% and 80% by weight, and the gel former (C), which can be a mixture of HPC including HPC-M and HPC-G is between 5% and 25% by weight, at least two solvents, wherein the proportion of solvent in the mixture is between 50% (v/v) to 100% (v/v) respectively 0% (v/v) to 50% (v/v) and water as one of the preferred solvents and also teaches the pharmaceutical composition further comprising a plasticizer which can be between 2-15% by weight, also because HPC-M in the amount of 2.5-3% by weight and HPC-G in the amount of 2-6% exhibits great viscosity as taught by Krekeler If 50% ethanol is used then the other 50% can be water. With respect to claim 133, one would reasonably expect the inclusion of the amount of 0.1-5% by weight of an active ingredient to provide an effective orodisopersible film formulation with success, by the fact that Krekeler teaches in the methods known to date for the formation of corresponding compositions in particular in the form of orodispersible films, that suggest the use of water as a solvent for a water-soluble active substance to be formulated, the maximum attainable proportion of active compound in the composition or in the film, especially of the aforesaid drugs sumatriptan succinate or sildenafil citrate is at most 10 wt %. (See paragraph [0090].) At most 10 wt% is construed to be less than or equal to 10 wt% which contemplates the 0.1-5% by weight claimed in claim 133.
Conclusion
Claims 57, 109, 110, 115-122, 127, and 130-133 are not allowed.
THIS ACTION IS MADE FINAL. 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 JEAN P CORNET whose telephone number is (571)270-7669. The examiner can normally be reached Monday-Thursday from 7.00am-5.30pm.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached on 571-272-1310. 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.
/JEAN P CORNET/Primary Examiner, Art Unit 1628