DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 18, 2026 has been entered.
Status of Claims
Claims 49 and 51-66 are currently pending. Claims 1-48 and 50 are canceled. Claims 49 and 51 are amended.
Previous Rejections
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn. The following rejections and/or objections are either reiterated or newly
applied. They constitute the complete set presently being applied to the instant application.
Rejections Withdrawn
Double Patenting
In light of the filing and approval of the terminal disclaimer the rejection of claims 49 and 51-66 on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of US Patent No. 12,161,763 is withdrawn.
Claim Rejections - 35 USC § 103
In light of the amendments to the claims the rejection of claims 49, 51-63 and 65-66 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Murty et al. US 2007/0104741 (5/10/2007) in view of Odidi et al. US 2009/0232887 (9/17/2009)(9/20/2019 IDS), Bromley et al. US 2010/0041622 (2/18/2010) )(9/20/2019 IDS) and Devane et al. US 2007/0160675(7/12/2007) as evidenced by Hustvedt et al. US 2016/0206585 (7/21/2016) and Murthy, Nanoparticles in modern Medicine: State of the art and future challenges, Int J Nanomedicine. 2007 Jun; 2(2):129-141 is withdrawn.
In light of the amendments to the claims the rejection of claim 64 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Murty et al. US 2007/0104741 (5/10/2007) in view of Odidi et al. US 2009/0232887 (9/17/2009)(9/20/2019 IDS), Bromley et al. US 2010/0041622 (2/18/2010) )(9/20/2019 IDS) and Devane et al. US 2007/0160675(7/12/2007) as evidenced by Hustvedt et al. US 2016/0206585 (7/21/2016) and Murthy, Nanoparticles in modern Medicine: State of the art and future challenges, Int J Nanomedicine. 2007 Jun; 2(2):129-141 as applied to claims 49, 51-63 and 65-66 and further in view of Desai et al. US 4,816,247 (3/28/1989) is withdrawn.
New Objection/Rejections
Claim Objections
Claim 49 is objected to because of the following informalities: the recitation of “O/W” and PDI. These terms appear to be abbreviations. The full name should be spelled out the first time these terms appear in the claims, or it cannot be clear what exactly these terms stand for. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 49, 51-63 and 65-66 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Murty et al. US 2007/0104741 (5/10/2007) in view of Odidi et al. US 2009/0232887 (9/17/2009)(9/20/2019 IDS), Bromley et al. US 2010/0041622 (2/18/2010) )(9/20/2019 IDS) and Devane et al. US 2007/0160675(7/12/2007) as evidenced by Hustvedt et al. US 2016/0206585 (7/21/2016) and the instant specification.
Murty et al. discloses a method of administering a cannabinoid such as cannabidiol so that the oral bioavailability is greatly enhanced when compared to known formulations. With enhanced absorption characteristics of oral delivery systems, Murty teaches that treatment could be useful for brain damage associated with stroke, head trauma, and cardiac arrest. This, however, requires sufficient bioavailability of the drug compound. (See Abstract, [0013] and claim 2). Treatment of brain damage from stroke is a disorder as called for in instant claim 52.
The composition is an oral dosage form of cannabinoids such as cannabidiol (CBD) in a self- emulsifying system comprising an oily medium of free fatty acids having from C6 to C32 carbon atoms and a surfactant which promotes self-emulsification. (See Murty claim 1). Cannabidiol (CBD) is called for in instant claim 54 and is a cannabinoid as called for in instant claim 53. The composition is a dispersible concentrate as called for in instant claim 32 and forms a dispersion upon contact with the GI tract fluids as called for in instant claim 49. (See [0029]).
Murty’s composition does not comprise curcumin as called for in instant claim 32. (See Murty throughout). Murty teaches a composition wherein the drug is formulated for administration in the same pharmaceutical formulation as called for in claim 57. (See [013] and claims 1 and 2).
Murty teaches that its composition may also comprise phospholipids as called for in instant claim 55. (See [0043]). Murty teaches that its method provides sufficient bioavailability for treatment with brain damage associated with stroke and head trauma and cardiac arrest. (See [0016]). This is a method for the treatment of at least one disease or disorder as called for in instant claim 52. This is also a teaching of increased bioavailability as called for in instant claim 49. Murty also teaches in Example 3 b) (0 active agent) in which a formulation is made that does not have a drug in it, thereby teaching a composition that is formulated for administration in separate formulations as called for in instant claim 58.
Fatty acids having from C6 to C32 carbon atoms are fatty acids that are solid components having a melting temperature about 25˚C as called for in instant claim 49. A surfactant which promotes self-emulsification is a surfactant as called for in instant claim 49. Sorbitan monolaurate is taught to be a suitable surfactant. (See [0042]). Sorbitan monolaurate is called for in instant claim 60. Sorbitan monooleate is also taught to be a suitable surfactant. (See [0042]). Sorbitan monooleate is called for in instant claim 61. Preferred co-solvents are taught to include ethanol, which is a hydrophilic organic solvent as called for in instant claim 66. (See [0074[). Murty also teaches that phospholipids are possible in its composition as called for in instant claim 55. (See [0043]).
Murty does not expressly teach nanoparticles or lower alkyl esters of lactic acid. Murty does not teach a combination of Span 80 and Tween 20 or the benefits of these surfactants. These deficiencies are made up for with the teachings of Odidi et al., Bromley et al. and Devane.
Odidi et al. (Odidi) teaches tetrahydrocannabinol in a formulation that is abuse resistant. (See Odidi [0058] and Abstract). Odidi also teaches ethyl lactate which is a lower alkyl ester of lactic acid as called for in instant claim 56. (See Odidi [0089]). Ethyl lactate is an amphiphilic solvent as called for in instant claim 49 and ethyl lactate itself is called for in instant claim 65. (See Odidi [0083]). Odidi teaches that its compositions can contain other actives. (See Odidi [0060]). Additionally, Odidi teaches nanoparticles. (See [0331]).
Bromley et al. (Bromley) teaches a combination of Span 80 and Tween 20 as surfactants in an oral formulation that includes an emulsion. (See Bromley Abstract, [0026], [0270])). Bromley teaches that these surfactants increase the stability of the emulsion. (See Bromley [0026]).
As evidenced by Hustvedt et al., the HLB of Span 80 is 4.3, and the HLB of Tween 20 is 16. (See Hustvedt claim 149). 4.3 is less than about 5 and 16 is at least about 8 as called for in instant claim 49.
Devane et al. teaches a composition comprising cephalosporin and at least one surfactant. Devane teaches that surfactants can be enhancers of bioavailability of a pharmaceutical active by enhancing the net transport across the gastrointestinal tract.
Devane et al. teaches at [0131]:
[0131] As used herein, the term "enhancer" refers to a compound which is capable of enhancing the absorption and/or bioavailability of an active ingredient by promoting net transport across the GIT in an animal, such as a human. Enhancers include but are not limited to medium chain fatty acids; salts, esters, ethers and derivatives thereof, including glycerides and triglycerides; non-ionic surfactants such as those that can be prepared by reacting ethylene oxide with a fatty acid, a fatty alcohol, an alkylphenol or a sorbitan or glycerol fatty acid ester; cytochrome P450 inhibitors, P-glycoprotein inhibitors and the like; and mixtures of two or more of these agents.
Devane also teaches nanoparticles having a size of less than about 2000 nm. Less than about 2000 nm overlaps with the less than 50 nm called for in instant claim 49. Additionally, specific embodiments of less than 50 nm are also taught. (See [0046]). Less than 50 nm overlaps with the less than 50 nm called for in instant claim 49. Devane teaches that the nanoparticles are in a dispersion medium that can include ethanol. (See [0103]).
It would be obvious to one of ordinary skill in the art following the Murty method to add ethyl lactate as taught by Odidi in order to have an abuse resistant composition as taught by Odidi.
It would be obvious to one of ordinary skill in the art following the Murty method of administering an oral dosage dispersible concentrate of cannabidiol in a self- emulsifying system comprising an oily medium of C6 to C32 fatty acids and self emulsifying surfactants to use a combination of Span 80 and Tween 20 as surfactants in the composition as taught by Bromley in order to increase the stability of the emulsion as taught by Bromley and in order to increase the bioavailabilty of the cannabidiol active by increasing transport across the gastrointestinal tract as taught by Devane et al.
With respect to the spontaneous formation of a homogenous and stable oil-in-water nanoemulsion of particles with a mean diameter of less than 50 nm and PDI of 0.2 or less in claims 49 and 51, the references are silent on the values of the homogenous and stable oil-in-water nanoemulsion that is spontaneously formed when contacted with an aqueous medium containing gastrointestinal fluids. However, Murty in view of Odidi, Bromley and Devane teach a method for increasing the bioavailability of an orally administered drug with the same components as those claimed in the same amounts (at the overlaps of the ranges) as those claimed and the method contain the same steps as those claimed. Namely, the combined teachings of Murty in view of Odidi, Bromley and Devane teach a method of orally administering an oral dosage dispersible concentrate of cannabidiol in a self- emulsifying system comprising an oily medium of C6 to C32 fatty acids and a combination of Span 80 and Tween 20 surfactants in ethyl lactate. Orally administering a composition comprising these components would necessarily contact the composition with an aqueous medium containing GI tract fluids upon which the composition would spontaneously form a homogenous and stable oil-in-water nanoemulsion of particles with a mean diameter of less than 50 nm and PDI of 0.2 or less as evidenced by Table 19 and paragraph [0271] of the instant specification. (CBD standing for cannabidiol)
The prior art composition with the same components as those claimed in the same amounts (at the overlaps of the ranges) that follows the same steps in the same method as that claimed would necessarily have the same properties as those of the claimed composition in the claimed method. See, Persion Pharms. LLC v. Alvogen Malta Operations LTD., 945 F.3d 1184, 1191, 2019 USPQ2d 494084 (Fed. Cir. 2019), where the court stated that a proper finding of inherency does not require that all limitations are taught in a single reference, and that inherency may meet a missing claim limitation when the limitation is "the natural result of the combination of prior art elements.”
Claim 64 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Murty et al. US 2007/0104741 (5/10/2007) in view of Odidi et al. US 2009/0232887 (9/17/2009)(9/20/2019 IDS), Bromley et al. US 2010/0041622 (2/18/2010) )(9/20/2019 IDS) and Devane et al. US 2007/0160675(7/12/2007) as evidenced by Hustvedt et al. US 2016/0206585 (7/21/2016) and the instant specification as applied to claims 49, 51-63 and 65-66 and further in view of Desai et al. US 4,816,247 (3/28/1989).
Murty in view of Odidi, Bromley and Devane is described supra. Murty in view of Odidi, Bromley and Devane do not teach tripalmitin. This deficiency is made up for with the teachings of Desai.
Desai et al. (Desai) teaches a lipid emulsion form compositions that provide a solubilized drug form for oral and parenteral administration which enhances the drug absorption and the therapeutic efficacy of the drug. (See Desai Abstract, (0035)). Desai teaches that the oil phase may comprise semisynthetic mono, di or triglycerides such as tripalmitin or tristearin. (See (0035). Tripalmitin is called for in instant claim 64.
It would be obvious to one of ordinary skill in the art following the Murty in view of Odidi, Bromley and Devane method of administering an oral dosage dispersible concentrate of cannabidiol in a self- emulsifying system comprising an oily medium and a combination of Span 80 and Tween 20 as surfactants in the composition to use tripalmitin in the oily medium as taught by Desai in light of Desai’s teaching if its suitability in an emulsion for delivering a hydrophobic drug and enhancing the drug absorption and therapeutic efficacy of the drug as taught by Desai.
Response to Arguments
Applicants’ arguments of March 9, 2026 have been fully considered and are found to be unpersuasive.
Applicants note the amendment to claim 49 and point out the support for it.
Applicants argue that the claimed elements are not taught in the applied prior art. Applicants note that the independent claims in their present form are more explicit with regarding to when the PNL comes into contact with aqueous media, such as GI, homogeneous, stable and extremely fine and non-solid nanoparticulate monodispersions are formed. Applicants assert that this property is a structural characteristic of both blank and drug-loaded PNL and is preserved across various types of active and non-active ingredients.
Applicants also note that while the advantages of minimizing particle size may be apparent, achieving it can be quite challenging. Applicants also argue that the Affidavit of Mohammed Alyan attests to the ability to produce such PNL particles with various types of oils and actives and the reliability of this property during storage. The Affidavit also attests that the data supports that the invention is extraordinary, surprising and unexpected. The Exhibits to the Affidavit demonstrate the ability to produce minimal particle size upon dispersion in water-based solutions and by extension GI fluids, the essential requirement of a combination of high and low HLB surfactants to preserve this property and also the contribution of the solid component. Murty neither teaches drug-devoid compositions nor compositions with combination of high and low HLB surfactants. Exhibit C of the Affidavit shows that a substantial part of the compositions in Murty will be unsuccessful in terms of particle size and/or dispersibility in water-based solutions. Consequently, Applicants assert that Murty teaches away from the composition of the present claims. Odidi does not cure the deficiencies of Murty regarding how to achieve superior combinations of surfactants.
Applicant asserts that Devane is unhelpful since its methods of reducing particle size are mechanical and related to solid particles. Applicants assert that Hustvedt also teaches away from the claims because it nowhere mentions a selection of surfactants with high and low HLB values.
Applicants note the Declarant’s attestation to the unexpected and surprising nature of the invention in view of the cited prior art in terms of superior dispersibility and oral bioavailability. Applicants argue that a person of ordinary skill in the art would not have a reasonable expectation of success.
Applicants’ arguments have been fully reviewed and are not found to be persuasive. Applicants’ arguments regarding the claimed elements of the composition not being taught in the prior art with respect to the spontaneous formation of homogeneous, stable and extremely fine and non-solid nanoparticulate upon contact with aqueous media containing GI fluids is not found to be persuasive. Respectfully, Applicants’ assertion that this property is a structural characteristic of both blank and drug-loaded PNL and is preserved across various types of active and non-active ingredients is not found to be entirely persuasive. While this property does flow from the elements of the claimed composition and the steps of the claimed method, the structural elements of the composition and method that give rise to these properties are all taught in the applied prior art.
The nanoparticle size is directed to what happens in the GI tract of a subject after oral administration, e.g., “contacting the orally administered drug and the composition with an aqueous medium in said subject”, the composition spontaneously forms a homogeneous and stable O/W nanoemulsion of particles with a mean diameter of less than 50 cm and PDI of 0.2 or less….”. Thus, the claims merely require that the prior art composition with all of the claimed compositional elements be orally administered and be contacted by an aqueous medium comprising grastrointestinal GI tract fluids.
Respectfully, contacting the orally administered drug and composition with an aqueous medium is what necessarily happens when the drug and composition are orally administered (they are swallowed into the stomach and contacted with gastrointestinal fluids) and the composition spontaneously transforms into a nanoemulsion of particles having a size of less than about 50 nm upon contact with GI tract fluids, e.g., this is a property of the composition that happens in the body of a subject following oral administration. Respectfully, this is not a structural limitation but a necessary result when the same composition with the same elements as those claimed follows the same steps of the same method as those claimed. Therefore, the silence regarding this size of nanoparticle does not matter, since it is a property of the composition and the method of oral administration, all the elements of which are disclosed by the prior art in the rejection.
With respect to the spontaneous formation of a homogenous and stable oil-in-water nanoemulsion of particles with a mean diameter of less than 50 nm and PDI of 0.2 or less in claims 49 and 51, the references are silent on the values of the homogenous and stable oil-in-water nanoemulsion that is spontaneously formed when contacted with an aqueous medium containing gastrointestinal fluids. However, Murty in view of Odidi, Bromley and Devane teach a method for increasing the bioavailability of an orally administered drug with the same components as those claimed in the same amounts (at the overlaps of the ranges) as those claimed and the method contain the same steps as those claimed. Namely, the combined teachings of Murty in view of Odidi, Bromley and Devane teach a method of orally administering an oral dosage dispersible concentrate of cannabidiol in a self- emulsifying system comprising an oily medium of C6 to C32 fatty acids and a combination of Span 80 and Tween 20 surfactants in ethyl lactate. Orally administering a composition comprising these components would necessarily contact the composition with an aqueous medium containing GI tract fluids upon which the composition would spontaneously form a homogenous and stable oil-in-water nanoemulsion of particles with a mean diameter of less than 50 nm and PDI of 0.2 or less as evidenced by Table 19 and paragraph [0271] of the instant specification. (CBD standing for cannabidiol)
The prior art composition with the same components as those claimed in the same amounts (at the overlaps of the ranges) that follows the same steps in the same method as that claimed would necessarily have the same properties as those of the claimed composition in the claimed method. See, Persion Pharms. LLC v. Alvogen Malta Operations LTD., 945 F.3d 1184, 1191, 2019 USPQ2d 494084 (Fed. Cir. 2019), where the court stated that a proper finding of inherency does not require that all limitations are taught in a single reference, and that inherency may meet a missing claim limitation when the limitation is "the natural result of the combination of prior art elements.”
Respectfully, Applicants’ teaching away arguments continue to be unpersuasive because none of the cited prior art references contains a teaching away.
With respect to Applicant’s assertion that Murty neither teaches particle size nor compositions with combination of high and low HLB surfactants, Murty teaching high HLB surfactants and not teaching particle size does not amount to a teaching away. This does not disparage a combination of high and low HLB surfactants or a particle size formation once in the GI system. Silence regarding the claimed solution does not disparage or discourage such a modification. A teaching away must be clear. See MPEP Sec. 2143.03 (VI). Additionally, the teaching of a combination of high and low HLB surfactants is supplied by other prior art references in the rejection, namely Bromley.
Devane does not teach away from the claimed invention either, since it does not criticize or discourage a combination of high and low HLB surfactants. Similarly, Hustvedt does not teach away from the instant claims and it does not criticize or discourage a combination of high and low HLB surfactants. As previously stated, silence regarding the claimed solution does not disparage or discourage such a modification. A teaching away must be clear. See MPEP Sec. 2143.03 (VI).
Bromley does not contain a teaching away either. Bromley does teach that a combination of Span 80 and Tween 20 as surfactants in an oral formulation increases the stability of the emulsion and just because other surfactants may be used does not undercut this teaching.
Respectfully, in response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The rejection is still not overcome. As described above, Murty teaches a method for improving the bioavailability of cannabidiol. Murty discloses a method of administering a cannabidiol in a self- emulsifying system comprising an oily medium of free fatty acids having from C6 to C32 carbon atoms and at least one surfactant which promotes self-emulsification. (See claim 1). The composition is a dispersible concentrate that forms a dispersion upon contact with the GI tract fluids. (See [0029]).
Murty’s method of administering a cannabidiol in a self- emulsifying system comprising an oily medium of free fatty acids having from C6 to C32 carbon atoms and a surfactant which is a dispersible concentrate that forms a dispersion upon contact with the GI tract fluids is modified by the teachings of Odidi in that it would be obvious for one of ordinary skill in the art to add ethyl lactate to make the dispersible concentrate resistant to abuse as taught by Odidi.
It would be obvious to one of ordinary skill in the art following the Murty method of administering a cannabidiol in a self- emulsifying system comprising an oily medium of free fatty acids having from C6 to C32 carbon atoms and a surfactant to use a combination of Span 80 and Tween 20 as surfactants in the composition as taught by Bromley in order to increase the stability of the emulsion as taught by Bromley and in order to increase the bioavailability of the cannabidiol active by increasing transport across the gastrointestinal tract as taught by Devane et al.
Furthermore, the prior art does not have to address the same problem as the Applicants. It is well established that the prior art does not need to recognize the same problem as the Applicant. In KSR Int' l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court cautioned that, "[i]n determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under § 103." Id. at 419. See also MPEP 2144(IV): The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991) (discussed below).
The articulated motivation in the rejection applied above for combining the references is more than sufficient to motivate one of ordinary skill in the art to combine the teachings of the references as described in the rejection. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991) (discussed below).
Respectfully, Applicants have not articulated any persuasive reason why the teachings of the prior art would not successfully result in the claimed invention. Absent evidence to the contrary, one of skill in the art would have a reasonable expectation of success as the prior art is all directed to compositions for delivering drugs and increasing their bioavailability and stability. Additionally, there is powerful motivation to combine the teachings of the prior art. The combination of Span 80 and Tween 20 surfactants taught by Bromley motivates its addition to the oral dosage dispersible concentrate of cannabidiol in the self- emulsifying Murty composition in order to increase the stability of the emulsion as taught by Bromley and in order to increase the bioavailability of the cannabidiol active by increasing transport across the gastrointestinal tract as taught by Devane et al.
With respect to Applicants’ assertion of unexpected results, this assertion is not found to be persuasive. Several of the cited pieces of prior art teach that their invention increases the bioavailability of the active ingredient. Murty expressly teaches that its method enhances bioavailability of CBD, so much so that it is possible to treat various potential ailments with CBD. Murty also teaches that its compositions are useful to improve the bioavailability and stability of various lipophilic drugs with poor aqueous solubility. (See [0094]).
Devane expressly teaches that its small particle size and surfactants can be enhancers of bioavailability of a pharmaceutical active by enhancing the net transport across the gastrointestinal tract. Devane also teaches that its compositions are stable at [108]. Murty, the primary reference in the rejection, teaches improved bioavailability and stability. Bromley also teaches a stable composition. (See Bromley claim 36, 37) Therefore, it would appear that the results are more expected than unexpected, since an increase in bioavailability and stability is taught by the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CHICKOS whose telephone number is (571)270-3884. The examiner can normally be reached on M-F 9-6.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
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.
/SARAH CHICKOS/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619