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 I (claims 1-47, 50, and 56-68), drawn to a pharmaceutical composition comprising a film-forming polymer, in the reply filed on November 21, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The restriction requirement is made FINAL.
Summary
Claims 1-47, 50, and 56-68 are pending in this office action. Claims 48-49 and 51-55 are withdrawn from consideration. All pending claims are under examination in this application.
Priority
The current application was filed on October 21, 2022. The current application claims domestic priority to provisional patent application 63/271,001 filed October 22, 2021.
Information Disclosure Statement
Receipt of the Information Disclosure Statements filed on January 13, 2025 (3) and September 19, 2023 (7) are acknowledged. A signed copy of the ten documents are attached to this office action.
Claim Objections
Claim 16, 18-23, 25-27, 29, 31-32, 34, 36-37, 41-44, 46-47, and 50 are objected to because of the following informalities:
Claim 16 is objected to as containing the following defect(s) in the form or contents thereof: the dependency on claim 13 appears as a typographical error and for the purposes of this examination the claim will be considered to be dependent on claim 14.
Claims 18-23 are objected to as containing the following defect(s) in the form or contents thereof: the dependency on claim 16 appears as a typographical error and for the purposes of this examination the claim will be considered to be dependent on claim 17.
Claims 25-27 are objected to as containing the following defect(s) in the form or contents thereof: the dependency on claim 23 appears as a typographical error and for the purposes of this examination the claim will be considered to be dependent on claim 24.
Claim 29 is objected to as containing the following defect(s) in the form or contents thereof: the dependency on claim 27 appears as a typographical error and for the purposes of this examination the claim will be considered to be dependent on claim 28 and the word "xantham" is misspelled and for the purposes of this examination considered "xanthan."
Claims 31 and 32 are objected to as containing the following defect(s) in the form or contents thereof: the dependency on claim 29 appears as a typographical error and for the purposes of this examination the claim will be considered to be dependent on claim 30.
Claim 32 has the acronym GMO. Please define this in full. Once defined, thereafter, the acronym can be used within the claim.
Claim 34 is objected to as containing the following defect(s) in the form or contents thereof: the dependency on claim 32 appears as a typographical error and for the purposes of this examination the claim will be considered to be dependent on claim 33.
Claim 36 is objected to as containing the following defect(s) in the form or contents thereof: the dependency on claim 34 appears as a typographical error and for the purposes of this examination the claim will be considered to be dependent on claim 35.
Claim 37 is objected to as containing the following defect(s) in the form or contents thereof: the dependency on claim 32 appears as a typographical error and for the purposes of this examination the claim will be considered to be dependent on claim 35.
Claims 41-44 are objected to as containing the following defect(s) in the form or contents thereof: the dependency on claim 37 or 1 appears as a typographical error and for the purposes of this examination the claim will be considered to be dependent on claim 40.
Additionally, claim 44 needs “the” amended before “plasticizer.”
Claims 46-47 and 50 are objected to as containing the following defect(s) in the form or contents thereof: the dependency on claim 42 appears as a typographical error and for the purposes of this examination the claim will be considered to be dependent on claim 45.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 31 and 37 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 31 and 37 contain the trademark/trade name Labrasol® and Magnasweet™, respectively. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a surfactant and a sweetener, respectively, and, accordingly, the identification/description is indefinite.
[Also, in order to eliminate all antecedent basis issues, the proper claim dependency needs to be amended within the claim set (as instructed within the claim objections).]
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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-47, 50, and 56-68 are rejected under 35 U.S.C. 103 as being unpatentable over Espinoza et al. (US2021/0322306A1) in view of Lefevre et al. (US8,652,513B2), Zhang et al. (US2020/0276114A1), Scaberi et al. (International Journal of Biological Macromolecules, 2017), Schobel et al. (WO2020/051317A1, published in March 2020), Hilliard et al. (US2014/0199354A1), Yang et al. (US2005/0037055A1), Zhang et al. (US2011/0105441A1), Reents et al. (US2018/0055845A1), Myers et al. (US2015/0150825A1), Sournac et al. (US2010/0041703A1), Kaur (US2020/0222362A1), and Myers et al. (US2020/0222544A1).
[The Examiner is going to introduce each new reference and then combine them where appropriate to reject the instant claims.]
1. Espinoza et al.
Espinoza et al. is considered the closest prior art as it teaches oral dissolvable film with high load of polymeric binder (see title). In addition, Espinoza et al. disclose that the present invention relates to an oral dissolvable film (ODF), methods of orally administering the same, and methods of manufacturing the same. The ODF includes a
high load of binder. Such an ODF, containing a high load of binder, can achieve the requisite physical and performance characteristics and can be manufactured on a commercial scale, while demonstrating that the ODF is safe and effective to consumers for its intended use. This also includes formulating and configuring the ODF to deliver the API as desired, via, e.g., enteral, transmucosal, sublingual, and/or buccal, when the administration is oral (see abstract).
2. Lefevre et al.
Lefevre et al. teach film-forming starchy composition (see title). Furthermore, Lefevre et al. disclose a film-forming starchy composition for the film-coating of solid forms or the preparation of films. The inventive composition has an amylose content of between 25 and 45%, preferably between 30 and 44% and still more preferably between 35 and 40%, the percentages being expressed by dry weight in relation to the dry weight of starch contained in the composition, and includes at least one stabilized starch. A method for the film-coating of solid forms is disclosed and includes spraying the film-forming composition onto a moving nuclei bed. The film-forming composition is used for the production of films and capsules (see abstract).
3. Zhang et al. ‘114
Zhang et al. ‘114 teach dipivefrin orally disintegrating tablet formulations (see title). Furthermore, Zhang et al. ‘114 disclose that this reference provides orally disintegrating dipivefrin tablet (ODT) formulations, including ODT formulations containing L-dipivefrin HCl. The ODT formulations of the disclosure include 10 to 70% binder (wt %), 5 to 50% matrix former (wt %), and 1 to 20% taste masking agent (wt %). The ODT formulations of the disclosure rapidly provide epinephrine to a patient when administered. The disclosure also provides a method of treating a patient who has a condition responsive to epinephrine such as a cardiac event, asthma, croup, cancer, a microbial infection, Addison's disease, or an allergic reaction, particularly anaphylaxis by administering an orally disintegrating dipivefrin tablet formulations to the patient (see abstract).
4. Saberi et al.
Saberi et al. teach physical and mechanical properties of a new edible film made of pea starch and guar gum as affected by glycols, sugars and polyols (see title). Additionally, Saberi et al. disclose that the influence of different plasticizers (glycols, sugars and polyols) on the moisture sorption, mechanical, physical, optical, and microstructure characteristics of pea starch-guar gum (PSGG) film was studied. All plasticizers formed homogeneous, transparent, and smooth films, while PEG-400 did not produce film with suitable characteristics. Fourier transform infrared (FTIR) spectroscopy results indicated some interaction between plasticizers and the polymers. Scanning electron microscopy (SEM) observations of the films presented surfaces without cracks, breaks, or openings which were indicator of the miscibility and compatibility of employed plasticizers with PSGG films. The results showed that the films containing plasticizers with higher functional groups had lower equilibrium moisture content at aw <0.4. In general, a reduction in tensile strength and Young’s modulus and an increase in elongation at break were detected when molecular weight of plasticizers and relative humidity increased in all film formulations. Films plasticized with monosaccharide showed similar mechanical properties to those with sorbitol, but lower solubility and water vapour permeability (WVP), higher transparency and moisture content than the sorbitol-plasticized films. The most noticeable plasticization effect was exerted by following order: glycerol > EG > PG > xylitol > fructose > sorbitol > mannitol > galactose > glucose > sucrose > maltitol (see abstract).
5. Schobel et al.
Schobel et al. teach oral film compositions and dosage forms having precise active dissolution profiles (see title). In addition, Schobel et al. disclose an oral film in an individual unit dose for delivery of one or more actives is disclosed herein. The film having a precisely calculated and controlled active dissolution profile. A wide variety of activities may be used, including, for example, clobazam. diazepam, or riluzole. Also disclosed are methods of treating a variety of diseases and conditions, for example, epilepsy and seizures by administering the oral film disclosed herein (see abstract).
6. Hilliard et al.
Hilliard et al. teach visually patterned and oriented compositions (see title). Also, Hilliard et al. disclose structured personal care compositions comprising a particle
having an aspect ratio of greater than 1.5 are contemplated, as well as methods for using such compositions. The compositions provide a visually distinguishable, oriented pattern that is aesthetically pleasant to provide consumer appeal and product identification (see abstract).
7. Yang et al.
Yang et al. teach polyethylene oxide-based films and drug delivery systems made therefrom (see title). Also, Yang et al. disclose that the invention relates to the film products and methods of their preparation that demonstrate a non-self-aggregating uniform heterogeneity. Desirably, the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film. The films contain a polymer component, which includes polyethylene oxide optionally blended with hydrophilic cellulosic polymers. Desirably, the films also contain a pharmaceutical and/or cosmetic active agent with no more than a 10% variance of the active agent pharmaceutical and/or cosmetic active agent per unit area of the film (see abstract).
8. Zhang et al.
Zhang et al. teach stable orally disintegrating tablets having low super disintegrant (see title). In addition, Zhang et al. disclose that the invention is directed to the functionality and performance of super disintegrants in orally disintegrating tablets (ODT). The invention can be an aged direct compression ODT having between about 0.3% to about 2% (wt/wt) sodium croscarmellose relative to the total weight of the ODT, a polyol matrix, optionally a lubricant, and an active pharmaceutical or nutraceutical ingredient, in which after storage for four months the ODT has a disintegration time using an excess water test that is less than 30 seconds and a tensile strength greater than 0.5 MPa. The invention is also directed to a direct compression ODT, consisting essentially of about 0.5% to 2.0% sodium croscarmellose, from 0.1% to 2.0% lubricant, an API, up to 10% (wt/wt) microcrystalline cellulose, optionally one or more colorants, sweeteners, fragrances, flavor compounds, and/or flavor blockers, and the balance spray-dried mannitol (see abstract).
9. Reents et al.
Reents et al. teach pharmaceutical compositions comprising akt protein kinase inhibitors (see title). Furthermore, Reents et al. disclose that the present invention relates to pharmaceutical compositions comprising Akt protein kinase inhibitors with therapeutic activity against diseases such as cancer as well as processes for their preparation and their use as medicament (see title).
10. Myers et al. ‘825
Myers et al. ‘825 teach method and system for forming a pharmaceutical product directly onto a packaging surface (see title). Additionally, Myers et al. ‘825 disclose that the present invention relates to a method for forming a pharmaceutical product, such as a dissolvable film dosage form, onto a surface. Particularly, the present invention relates to a method of forming a pharmaceutical product directly onto the surface of a substrate (see abstract).
11. Sournac et al.
Sournac et al. teach rapid disintegration monolayer film for the oral administration of active substances (see title). Furthermore, Sournac et al. disclose rapid-disintegration monolayer film for the oral administration of active substances, comprising a water-soluble support containing at least one active substance, characterized in that it comprises a polymeric mixture of a hydrophilic film-forming agent formed from a copolymer of polyvinyl alcohol and of polyethylene glycol (PVA-PEG), of an active substance and of a hydrophilic gelling agent (see abstract).
12. Kaur
Kaur teaches oral disintegrating films for cannabis products (see title). Also, Kaur discloses an oral disintegrating film including a cannabinoid or cannabinoid analogue, a first film forming polymer and a solubilizing agent are disclosed as well as methods of using same (see abstract).
13. Myers et al.
Myers et al. teach linear polysaccharide-based film products (see title). Additionally, Myers et al. disclose film products, especially suitable for oral delivery, which can be formed during manufacture in the form of large and/or heavy film strips or sheets and subsequently cut into uniform dosage units, each dosage unit being uniform in content and having distributed therein a linear polysaccharide, such as pullulan, a plasticizer, and an active component (see abstract).
Combination of Espinoza et al. and Lefevre et al.
Regarding instant claim 1, Espinoza et al. and Lefevre et al. teach a pharmaceutical composition with enhanced dissolution. The necessary citations of Espinoza et al. and Lefevre et al. that pertain to instant claim 1 are presented in Table I.
Table I
Instant Claim 1
Espinoza et al. and Lefevre et al. Citations
A pharmaceutical composition with enhanced dissolution comprising
Espinoza et al. disclose a pharmaceutical composition with enhanced dissolution [oral dissolvable film (pharmaceutical composition)] (see abstract and paragraph [0006] within Espinoza et al.)
active ingredient, a film forming polymer including a starch ether, and a desiccant.
Espinoza et al. disclose a disintegrating agent (enhanced dissolution) (see paragraphs [0010-0011] and [0053] within Espinoza et al.) comprising an active ingredient (active ingredient; see paragraph [0010] within Espinoza et al.), a film forming polymer (film forming polymer; see paragraph [0010] within Espinoza et al.) including a starch ether, and a desiccant [moisture adsorbent (desiccant); see paragraphs [0020] and [0051] within Espinoza et al.], but Espinoza et al. does not disclose including a starch ether.
However, Lefevre et al. disclose comprising a starch ether [including hydroxypropylation of starch (hydroxypropyl ether of starch); see column 4, lines 25-40 within Lefevre et al.].
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. to provide the composition comprising including a starch ether, as disclosed by Lefevre et al., for the benefit that ethers of starch stabilize the starch for use in film forming compositions with additional film-forming polymers (see column 4, lines 25-40 and 54-64 within Lefevre et al.).
Therefore, a skilled artisan (POSITA) would consult the disclosures of Espinoza et al. and Lefevre et al. to teach all the elements of instant claim 1.
The remainder of the instant claims which are either directly or indirectly dependent on claim 1 are taught in full by the combination of Espinoza et al. and Lefevre et al.
Regarding instant claims 2 and 3, Espinoza et al. and Lefevre et al. teach wherein the starch ether is a hydroxyalkyl ether of a starch. Espinoza et al. does not disclose wherein the starch ether is a hydroxyalkyl ether of a starch. However, Lefevre et al. disclose wherein the starch ether is a hydroxyalkyl ether of a starch (starch ether is a hydroxypropyl (hydroxyalkyl) ether of starch; see column 4, lines 25-40 within Lefevre et al.).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al., to provide the composition wherein the starch ether is a hydroxyalkyl ether of a starch, as disclosed by Lefevre et al., for the benefit hydroxypropyl ethers of starch stabilize the starch for use in film forming polymer compositions with additional film-forming polymers (see column 4, lines 25-40 and 54-64 within Lefevre et al.).
Regarding instant claim 4, Espinoza et al. and Lefevre et al. teach wherein the film forming polymer is a pea starch. Espinoza et al. does not disclose wherein the film forming polymer is a pea starch. However, Lefevre discloses wherein the film forming polymer is a pea starch (film forming polymer is a pea starch; see column 4, lines 1-5 within Lefevre et al.).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al., to provide the composition wherein the film forming polymer is a pea starch, as disclosed by Lefevre et al., for the benefit pea starch is an amylase rich starch advantageously suited for film-forming compositions with additional film-forming polymers (see column 4, lines 25-40 and 54-64 within Lefevre et al.).
Regarding instant claim 8, Espinoza et al. and Lefevre et al. teach wherein the active ingredient comprises 0.1% to 80% of the composition by weight. Espinoza et al. disclose wherein the active ingredient comprises 0.1 percent to 80 percent of the composition by weight (active ingredient is present in 20 percent to 40 percent of the composition by weight; see paragraph [0142] within Espinoza et al.).
Regarding instant claim 9, Espinoza et al. and Lefevre et al. teach further comprising a stabilizer. Espinoza et al. disclose further comprising a stabilizer within the composition (further comprises a stabilizer; see paragraphs [0020] and [0063] within Espinoza et al.).
Regarding instant claim 11, Espinoza et al. and Lefevre et al. teach further comprising an antioxidant. Espinoza et al. disclose further comprising an antioxidant within the composition (further comprising an antioxidant; see paragraphs [0020] and [0064] within Espinoza et al.).
Regarding instant claim 14, Espinoza et al. and Lefevre et al. teach further comprising a permeation enhancer. Espinoza et al. disclose further comprising a permeation enhancer within the composition (further comprises a permeation enhancer; see paragraphs [0020] and [0054] within Espinoza et al.).
Regarding instant claim 17, Espinoza et al. and Lefevre et al. teach further comprising a processing solvent. Espinoza et al. disclose further comprising a processing solvent within the composition [solvent employed to form slurry (processing solvent); see paragraph [0032] within Espinoza et al.].
Regarding instant claims 18 and 19, Espinoza et al. and Lefevre et al. teach wherein the processing solvent is an organic processing solvent. Espinoza et al. disclose further wherein the processing solvent is an organic processing solvent (processing solvent is ethanol or acetone; see paragraph [0032] within Espinoza et al.).
Regarding instant claim 24, Espinoza et al. and Lefevre et al. teach further comprising a plasticizer. Espinoza et al. disclose further comprising a plasticizer within the composition (plasticizer; see paragraphs [0020] and [0034] within Espinoza et al.).
Regarding instant claim 28, Espinoza et al. and Lefevre et al. teach further comprising a viscosity builder. Espinoza et al. disclose further comprising a viscosity builder within the composition (viscosity builder; see paragraph [0049] within Espinoza et al.).
Regarding instant claim 30, Espinoza et al. and Lefevre et al. teach further comprising a surfactant. Espinoza et al. disclose further comprising a surfactant within the composition (further comprises a surfactant; see paragraph [0044] within Espinoza et al.).
Regarding instant claim 35, Espinoza et al. and Lefevre et al. teach further comprising a sweetener. Espinoza et al. disclose further comprising a sweetener within the composition (further comprising a sweetener; see paragraph [0031] within Expinoza et al.).
Regarding instant claim 38, Espinoza et al. and Lefevre et al. teach further comprising a flavoring agent. Espinoza et al. disclose further comprising a flavoring agent within the composition (comprising a flavoring agent; see paragraphs [0019] and [0035] within Espinoza et al.).
Regarding instant claim 39, Espinoza et al. and Lefevre et al. teach further comprising a coloring agent. Espinoza et al. disclose further comprising a coloring agent within the composition (comprising a colorant; see paragraphs [0020] and [0040] within Espinoza et al.).
Combination of Espinoza et al., Lefevre et al., and Reents et al.
Regarding instant claim 5, Espinoza et al., Lefevre et al., and Reents et al. teach wherein the desiccant includes a silica. Reents et al. disclose wherein the desiccant includes a silica [moisture adsorbent (desiccant) is a silica; see paragraphs [0140-0142] within Reents et al.].
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre, in combination, to provide the composition wherein the desiccant includes a silica, as disclosed by Reents et al., for the benefit that the moisture adsorbent silica is used in pharmaceutical compositions to increase stability of active agents (see paragraphs [0137] and [0140-0142] within Reents et al.).
Regarding instant claim 6, Espinoza et al., Lefevre et al., and Reents et al. teach wherein the desiccant includes a fumed silica or a mesoporous silica. Reents et al. disclose wherein the desiccant includes a fumed silica (moisture adsorbent (desiccant) is a fumed silica; see paragraphs [0140-0142] within Reents et al.).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre, in combination, to provide the composition wherein the desiccant includes a fumed silica, as disclosed by Reents et al., for the benefit that the moisture adsorbent fumed silica is used in pharmaceutical compositions to increase stability of active agents (see paragraphs [0137] and [0140-0142] within Reents et al.).
Regarding instant claim 7, Espinoza et al., Lefevre et al., and Reents et al. teach wherein the film forming polymer and the desiccant have a ratio of 10:1 to 2:1 by weight. Espinoza et al. disclose wherein the film forming polymer is present in at least 30 percent by weight of the composition (see paragraph [0010] within Espinoza et al.), but Espinoza et al. does not disclose wherein the film forming polymer and the desiccant have a ratio of 10:1 to 2:1 by weight. However, Reents et al. disclose wherein the moisture adsorbent (desiccant) comprises to 10 percent by weight of the pharmaceutical composition (see paragraph [0143] within Reents et al.), and when combined with Espinoza et al. disclose wherein the film forming polymer and the desiccant have a ratio of 10:1 to 2:1 by weight.
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre, in combination, to provide the composition wherein the film forming polymer and the desiccant have a ratio of 10:1 to 2:1 by weight, as disclosed by Reents et al., for the benefit that the moisture adsorbent fumed silica is used in pharmaceutical compositions with polymers to increase stability of active agents (see paragraphs [0137] and [0140-0142] within Reents et al.).
Combination of Espinoza et al., Lefevre et al., and Yang et al.
Regarding instant claim 12, Espinoza et al., Lefevre et al., and Yang et al. teach wherein the stabilizer includes an ion exchange resin. Espinoza et al. does not disclose wherein the stabilizer includes an ion exchange resin. However, Yang et al. disclose wherein the active ingredient can include an ion exchange resin (see paragraph [0131] within Yang et al.). Therefore, a skilled artisan (POSITA) would be able to add an ion exchange resin to a stabilizer as a substance used to prevent or mitigate the occurrence of degradation of any one of more substances present in a formulation (e.g., the slurry
and/or oral dissolvable film). This would include preventing or mitigating degradation of the active ingredient, as well as any of the inactive ingredients or excipients (see paragraph [0063] within Espinoza et al.) under routine experimental conditions.
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre et al., in combination, to provide the composition wherein the composition may comprise an ion exchange resin, as disclosed by Yang et al., for the benefit that uniform pharmaceutical films with active ingredients comprising an ion exchange resin (see paragraph [0131] within Yang et al.).
Regarding instant claim 13, Espinoza et al., Lefevre et al., and Yang et al. teach wherein the stabilizer includes a cation exchange resin. Espinoza et al. does not disclose wherein the stabilizer includes a cation exchange resin. However, Yang et al. disclose wherein the active ingredient can include an ion exchange resin (see paragraph [0131] within Yang et al.). Therefore, a skilled artisan (POSITA) would be able to add a cation exchange resin by modifying and selecting a specific ion exchange resin for addition to a stabilizer as a substance which is used to prevent or mitigate the occurrence of degradation of any one of more substances present in a formulation (e.g., the slurry and/or oral dissolvable film). This would include preventing or mitigating degradation of the active ingredient, as well as any of the inactive ingredients or excipients (see paragraph [0063] within Espinoza et al.) under routine experimental conditions.
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre et al., in combination, to provide the composition wherein the composition may comprise an cation exchange resin, as disclosed by Yang et al., for the benefit that uniform pharmaceutical films with active ingredients comprising an ion exchange resin (see paragraph [0131] within Yang et al.).
Regarding instant claims 20-23, Espinoza et al., Lefevre et al., and Yang et al. teach wherein the processing solvent includes 20%-50% ethanol. Espinoza et al. and Lefevre et al., in combination, disclose the composition of instant claim 17, but Espinoza et al. does not disclose wherein the processing solvent includes 20%-50% percent ethanol. However, Yang et al. disclose wherein the processing solvent includes at least 20 percent ethanol (processing solvent includes at least 30 percent ethanol; see paragraph [0100] within Yang et al.).
Additionally, Yang et al. disclose wherein the processing solvent includes at least 40 percent ethanol (processing solvent includes at least 30 percent ethanol includes at least 40 percent ethanol; Table 6; paragraph [0100] within Yang et al.). Moreover, Yang et al. disclose wherein the processing solvent includes at least 50 percent ethanol (processing solvent includes at least 30 percent ethanol includes at least 50 percent ethanol; paragraph (0100] within Yang et al.).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre et al., in combination, to provide the composition wherein the processing solvent includes at least 20-50 percent ethanol, as disclosed by Yang et al., for the benefit that uniform pharmaceutical films with active ingredients are prepared using polar solvents including ethanol (see paragraph [0100] within Yang et al.).
Combination of Espinoza et al., Lefevre et al., and Saberi et al.
Regarding instant claim 25, Espinoza et al., Lefevre et al., and Saberi et al. teach wherein the plasticizer includes a polyol. Espinoza et al. does not disclose wherein the plasticizer includes a polyol. However, Saberi et al. disclose wherein the plasticizer includes polyols (xylitol, sorbitol, and mannitol; see abstract within Saberi et al.).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre et al., in combination, to provide the composition wherein the plasticizer includes a polyol, as disclosed by Saberi et al., for the benefit that several polyols are a suitable plasticizer for use is oral starch films (see abstract within Saberi et al.).
Regarding instant claim 26, Espinoza et al., Lefevre et al., and Saberi et al. teach wherein the plasticizer includes a pentatol. [The Applicant is requested to confirm the plasticizer pentatol.] Espinoza et al. does not disclose wherein the plasticizer includes a pentatol. However, Saberi et al. disclose wherein the plasticizer includes a pentatol (a polyol like xylitol, sorbitol, or mannitol) (choices include plasticizers like glycerol > EG > PG > xylitol > fructose > sorbitol > mannitol > galactose > glucose > sucrose > maltitol; see abstract within Saberi et al.).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre et al., in combination, to provide the composition wherein the plasticizer includes a pentatol, as disclosed by Saberi et al., for the benefit that numerous sugar alcohols are a suitable plasticizer for use is oral starch films (see abstract within Saberi et al.).
Regarding instant claim 27, Espinoza et al., Lefevre et al., and Saberi et al. teach wherein the plasticizer includes a sucralose: sugar alcohols such as sorbitol, mannitol, xylitol. Espinoza et al. does not disclose wherein the plasticizer includes a sucralose; sugar alcohols such as sorbitol, mannitol, xylitol. However, Saberi et al. disclose wherein the plasticizer includes sorbitol (sorbitol; see abstract within Saberi et al.).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre et al., in combination, to provide the composition wherein the plasticizer includes a sorbitol, as disclosed by Saberi et al., for the benefit that sorbitol is a suitable plasticizer for use is oral starch films (see abstract within Saberi et al.).
Combination of Espinoza et al., Lefevre et al., and Sournac et al.
Regarding instant claim 29, Espinoza et al., Lefevre et al., and Sournac et al. teach wherein the viscosity builder includes gelatin, xantham gum, ethyl cellulose, hydroxy propyl cellulose, methyl cellulose, microcrystalline cellulose. chitosan, natural gums, polyvinyls, crosslinked polymers, or other synthetic polymers. Espinoza et al. and Lefevre et al., in combination, disclose the composition of instant claim 28, but Espinoza et al. does not disclose wherein the viscosity builder includes gelatin, xanthan gum, ethyl cellulose, hydroxy propyl cellulose, methyl cellulose, microcrystalline cellulose, chitosan, natural gums, polyvinyls, crosslinked polymers, or other synthetic polymers. However, Sournac et al. disclose wherein the viscosity builder includes xanthan gum (xanthan gum; paragraph (0029]), or natural gums (gellan (natural) gum; see paragraph 0033] within Sournac et al.).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, Espinoza et al. and Lefevre et al., in combination, to provide the composition wherein the viscosity builder includes xanthan gum or natural gums, as disclosed by Sournac et al., for the benefit that xanthan gums and gellan (natural gum) are combined with a film-forming polymer in preparing rapid-disintegration films for delivery of active substances (see paragraphs [0019-0020] and [0030] within Sournac et al.).
Combination of Espinoza et al., Lefevre et al., and Kaur
Regarding instant claim 31, Espinoza et al., Lefevre et al., and Kaur teach wherein the surfactant includes Labrasol®. Espinoza et al. and Lefevre et al., in combination, disclose the composition of instant claim 30, but Espinoza et al. does not disclose wherein the surfactant includes glycerol macrogolglycerides. However, Kaur discloses wherein the surfactant includes glycerol macrogolglycerides such as Labrasol® (glycerol macrogolglycerides; see paragraph [0052] within Kaur).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre et al., in combination, to provide the composition wherein the surfactant includes glycerol macrogolglycerides, as disclosed by Kaur, for the benefit that oral disintegrating films containing active agents and film-forming polymers (see paragraphs [0023-0027] within Kaur).
Combination of Espinoza et al., Lefevre et al., and Myers et al.
Regarding instant claim 32, Espinoza et al., Lefevre et al., and Myers et al. teach wherein the surfactant includes GMO. Espinoza et al. and Lefevre et al., in combination, disclose the composition of instant claim 30, but Espinoza et al. does not disclose wherein the surfactant includes GMO. However, Myers et al. disclose wherein the surfactant includes GMO (surfactant includes glyceryl monooleate (GMO); see paragraph [0103] within Myers et al.).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre et al., in combination, to provide the composition wherein the surfactant includes GMO, as disclosed by Myers et al., for the benefit that surfactant including GMO are used in preparation of oral films with linear polysaccharide film-forming polymers containing active ingredients (see paragraphs [0031], [0045], and [0103]).
Combination of Espinoza et al., Lefevre et al., and Myers et al. ‘825
Regarding instant claim 10, Espinoza et al., Lefevre et al., and Myers et al. ‘825 teach wherein the stabilizer includes a chelating agent. Espinoza et al. and Lefevre et al., in combination, disclose the composition of instant claim 9, but Espinoza et al. does not disclose wherein the stabilizer includes a chelating agent. However, Myers et al. ‘825 disclose wherein a permeation enhancer includes chelating agents such as EDTA (see paragraph [0087] within Myers et al. ‘825). Despite the chelating agent not being formulated with the stabilizer, a skilled artisan (POSITA; person of ordinary skill in the art) could add the chelating agent to the stabilizer under routine experimental conditions.
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre et al., in combination, to provide the composition wherein a chelating agent is added to the overall composition, as disclosed by Myers et al. ‘825, for the benefit that chelating agents are used in pharmaceutical films as stabilizing agents.
Regarding instant claim 37, Espinoza et al., Lefevre et al., and Myers et al. ‘825 teach wherein the sweetener includes Magnasweet™. Espinoza et al. and Lefevre et al., in combination, disclose the composition of instant claim 35, but Espinoza et al. does not disclose wherein the sweetener includes monoammonium glycyrrhizinate. However, Myers et al. ‘ 825 disclose wherein the sweetener includes monoammonium glycyrrhizinate [sweetener includes Magnasweet (monoammonium glycyrrhizinate); see paragraphs [0085] and [0147] within Myers et al. ‘825].
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre et al., in combination, to provide the composition wherein the sweetener includes monoammonium glycyrrhizinate, as disclosed by Myers et al. ‘825, for the benefit that Magnasweet (monoammonium glycyrrhizinate) is used in pharmaceutical films as a taste-enhancing agent (see paragraphs [0020], [0023], and [0085] within Myers et al. ‘825).
Combination of Espinoza et al., Lefevre et al., and Schobel et al.
Regarding instant claim 15, Espinoza et al., Lefevre et al., and Schobel et al. teach further comprising a permeation enhancer includes an adrenergic receptor interacter. Espinoza et al. does not disclose wherein the permeation enhancer includes an adrenergic receptor interacter. However, Schobel et al. disclose wherein a permeation enhancer includes an adrenergic receptor interacter (see paragraph [00172] within Schobel et al.).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre et al., in combination, to provide the composition wherein the permeation enhancer includes an adrenergic receptor interacter, as disclosed by Schobel et al., for the benefit of modification and/or otherwise alters the action of an adrenergic receptor (see paragraph [00172] within Schobel et al.).
Regarding instant claim 16, Espinoza et al., Lefevre et al., and Schobel et al. teach wherein the permeation enhancer includes eugenol. Espinoza et al. does not disclose wherein the permeation enhancer includes eugenol. However, Schobel et al. disclose wherein the permeation enhancer includes eugenol (see paragraph [00177] within Schobel et al.).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre et al., in combination, to provide the composition wherein the permeation enhancer includes eugenol, as disclosed by Schobel et al., for the benefit of modification and/or otherwise alters the action of an adrenergic receptor (see paragraphs [00172] and [00176] within Schobel et al.).
Regarding instant claim 33, Espinoza et al., Lefevre et al., and Schobel et al. teach further comprising an esterase inhibitor. Espinoza et al. does not disclose further comprising an esterase inhibitor. However, Schobel et al. disclose further comprising an esterase inhibitor (see paragraph [0046] within Schobel et al.).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre et al., in combination, to provide the composition further comprising an esterase inhibitor, as disclosed by Schobel et al., for the benefit of diversifying the active ingredients (see paragraphs [0046] within Schobel et al.).
Regarding instant claim 34, Espinoza et al., Lefevre et al., and Schobel et al. teach further comprising an esterase inhibitor including NaF. Espinoza et al. does not disclose further comprising an esterase inhibitor including NaF. However, Schobel et al. disclose further comprising an esterase inhibitor (see paragraph [0046] within Schobel et al.). A skilled artisan (POSITA) would know that sodium fluoride is an esterase inhibitor and use that knowledge to expand the list of esterase inhibitors used within the pharmaceutical composition (see PTO-892 NPL U).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre et al., in combination, to provide the composition further comprising an esterase inhibitor including NaF, as disclosed by Schobel et al. and PTO-892 NPL U, for the benefit of diversifying the active ingredients (see paragraphs [0046] within Schobel et al.).
Regarding instant claim 36, Espinoza et al., Lefevre et al., and Schobel et al. teach wherein the sweetener includes sucralose. Espinoza et al. does not disclose wherein the sweetener includes sucralose. However, Schobel et al. disclose wherein the sweetener includes sucralose (see paragraph [00132] within Schobel et al.).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre et al., in combination, to provide the composition wherein the sweetener includes sucralose., as disclosed by Schobel et al., for the benefit of expanding the list of sweeteners (see paragraphs [00132] within Schobel et al.).
Combination of Hilliard et al. and Saberi et al.
Regarding instant claim 40, Hilliard et al. and Saberi et al. teach a pharmaceutical composition for delivering a pharmaceutical composition with enhanced stability comprising an active ingredient, a pH modifier including HCl, and a plasticizer including a non-reducing sugar. Hilliard et al. disclose a pharmaceutical composition for delivering a pharmaceutical composition with enhanced stability (see paragraph [0127] within Hilliard et al.) comprising an active ingredient (see paragraph [0113] within Hilliard et al.), a pH modifier including HCl (see paragraph [0126] and [0099] within Hilliard et al.), and a plasticizer (see paragraph [0127] within Hilliard et al.) including a non-reducing sugar (see abstract within Saberi et al.).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Hilliard et al., to provide the composition for delivering a pharmaceutical composition with enhanced stability comprising an active ingredient, a pH modifier including HCl, and a plasticizer including a non-reducing sugar, as disclosed by Saberi et al., for the benefit of adding non-reducing sugars as the plasticizer of choice (see abstract within Saberi et al.).
Regarding instant claims 41-43, Hilliard et al. and Saberi et al. teach wherein the non-reducing sugar is a polyol, pentatol, and xylitol. Please see the discussion and citations within instant claims 25-27 for the necessary rejection text.
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Hilliard et al., to provide the composition wherein the non-reducing sugar is a polyol, pentatol, and xylitol, as disclosed by Saberi et al., for the benefit of adding non-reducing sugars as the plasticizer of choice (see abstract within Saberi et al.).
Combination of Hilliard et al., Saberi et al., and Schobel et al.
Regarding instant claim 44, Hilliard et al., Saberi et al., and Schobel et al. teach wherein the pH modifier results in a formulation pH of 2.5 to 3.5 and plasticizer has a ratio of 1:20 to 1:8 by weight. Hilliard et al. disclose wherein the pH modifier results in a formulation pH of 2.5 to 3.5 (see paragraph [0126] within Hilliard et al.) and plasticizer has a ratio of 1:20 to 1:8 by weight (see page 98, Example 1 within Schobel et al.; plasticizer = sugar alcohol 15% by wt.).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Hilliard et al. and Saberi et al., in combination, to provide the composition wherein the pH modifier results in a formulation pH of 2.5 to 3.5 (see paragraph [0126] within Hilliard et al.) and plasticizer has a ratio of 1:20 to 1:8 by weight, as disclosed by Schobel et al., for the benefit of preparing the pharmaceutical composition (see page 98, Example 1 within Schobel et al.).
Combination of Myers et al. and Zhang et al.
Regarding instant claims 45-47 and 50, Myers et al. and Zhang et al. teach a pharmaceutical film product comprising an active ingredient. a stabilizer, a plasticizer, and the film product has a small volume disintegration value in the range of about 1 to about 240 seconds as measured according to a small volume disintegration assay. Myers et al. discloses a pharmaceutical film product (pharmaceutical film product; see claim 1; and paragraph [0045] within Myers et al.) comprising an active ingredient (active ingredient; see paragraph [0045] within Myers et al.), a stabilizer (anti-oxidant agent (stabilizer); see paragraph [0083] within Myers), a plasticizer (plasticizer; see paragraph [0091] within Myers et al.), and the film product has disintegration value in the range of about 1 to about 240 seconds [the film product has a dissolution (disintegration) value in the range of 2 to 10 seconds; see paragraph [0188] within Myers et al.], but Myers et al. does not disclose comprising a small volume disintegration value as measured according to a small volume disintegration assay. However, Zhang et al. disclose a small volume disintegration value as measured according to a small volume disintegration assay (a small volume disintegration values as measured according to a small volume disintegration assay; see paragraph [0111-0114] within Zhang et al.).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the product, as disclosed by Myers et al., to provide the product comprising a small volume disintegration value as measured according to a small volume disintegration assay, as disclosed by Zhang et al., for the benefit that quick oral dissolvable products disintegration times are measured in a small volume disintegration assay (see paragraphs [0034] and [0111-0114] within Zhang et al.).
Combination of Espinoza et al., Lefevre et al., and Zhang ‘114
Regarding instant claim 56, Espinoza et al., Lefevre et al., and Zhang ‘114 teach wherein the active ingredient includes a prodrug of epinephrine. Espinoza et al. does not disclose wherein the active ingredient includes a prodrug of epinephrine. However, Zhang ‘114 discloses wherein the prodrug of epinephrine (prodrug of epinephrine also known as dipivefrin; paragraph [0005] within Zhang ‘114). A skilled artisan (POSITA) would have added this active ingredient to the list of active pharmaceutical ingredients disclosed by Espinoza et al. (see paragraph [0055] within Espinoza et al.) due to the parent drug, epinephrine, is used to treat a number of conditions including anaphylaxis, cardiac arrest, and superficial bleeding, asthma and croup. Injectable epinephrine has also been shown to be efficacious for preventing and treating cancer (see paragraph [0004] within Zhang ‘114). Furthermore, the prodrug of epinephrine, dipivefrin, has been shown to have superior bio-penetrating abilities (see paragraph [0003] within Zhang ‘114).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre et al., in combination, to provide the composition wherein the active ingredient includes a prodrug of epinephrine, as disclosed by Zhang ‘114, for the benefit prodrugs of epinephrine are administered orally in pharmaceutical films to-deliver effective plasma levels (see paragraphs [0003-0004] within Zhang ‘114).
Regarding instant claim 57, Espinoza et al., Lefevre et al., and Zhang ‘114 teach further comprising a degradant. Espinoza et al. does not disclose further comprising a degradant. However, Zhang ‘114 discloses further comprising a degradant (further comprising a degradant; see Table 2.4 and paragraph [0073] within Zhang ‘114).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre et al., to provide the composition further comprising a degradant, as disclosed by Zhang ‘114, for the benefit that dipivefrin (prodrug of epinephrine) in oral rapidly disintegrating tablets (pharmaceutical composition) with a polymer matrix have present small amounts of degradants (see paragraphs [0044], [0047], and [0073] within Zhang ‘114).
Regarding instant claim 58, Espinoza et al., Lefevre et al., and Zhang ‘114 teach wherein the degradant is a hydrolysis product of the prodrug of epinephrine. Espinoza et al. does not disclose wherein the degradant is a hydrolysis product of the prodrug of epinephrine. However, Zhang ‘114 discloses wherein the degradant is a hydrolysis product of the prodrug of epinephrine (degradant is a hydrolysis product of the prodrug of epinephrine; see Table 2.4 and paragraph [0073] within Zhang ‘114).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre et al., to provide the composition wherein the degradant is a hydrolysis product of the prodrug of epinephrine, as disclosed by Zhang ‘114, for the benefit that main degradation pathway of dipivefrin (prodrug of epinephrine) is ester hydrolysis (see paragraphs [0073] and [0087] within Zhang ‘114).
Regarding instant claim 59, Espinoza et al., Lefevre et al., and Zhang ‘114 teach wherein the degradant is a portion of the delivered active ingredient delivered to a subject. Espinoza et al. does not disclose wherein the degradant is a portion of the delivered active ingredient delivered to a subject: However, Zhang ‘114 discloses wherein the degradant is a portion of the delivered active ingredient delivered to a subject (the degradant is a portion of the delivered active ingredient delivered to a subject; see Table 3.3 and paragraph [0049] within Zhang ‘114).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre et al., to provide the composition wherein the degradant is a portion of the delivered active ingredient delivered to a subject, as disclosed by Zhang ‘114, for the benefit that main degradation pathway of dipivefrin (prodrug of epinephrine) is present in an oral disintegrating tablet (dosage from) for administration to subjects (see paragraphs [0044], [0073], and [0087] within Zhang ‘114).
Regarding instant claims 60-62, Espinoza et al., Lefevre et al., and Zhang ‘114 teach wherein the degradant level is present at the required level and time period. Espinoza et al. does not disclose wherein the degradant level is present at the required level and time period. However, Zhang ‘114 discloses wherein the degradant level is present at the required level and time period (degradant level is present at 4.95 percent at 8 weeks at 60 degrees Celsius (includes degradant level is present at about 3.5 percent or more at the end of 6 months, or where the degradant level is present at about 2.3 percent or more at the end of 12 months, or where the degradant level is present at about 2.4 percent or more at the end of 24 months); see Table 4.2 within Zhang ‘114).
It would have been obvious to one skilled in the art prior to the effective filing date of the claimed invention to have modified the composition, as disclosed by Espinoza et al. and Lefevre et al., to provide the composition wherein the degradant level is present at the required level and time period, as disclosed by Zhang ‘114, for the benefit that degradants of dipivefrin (prodrug of epinephrine) are present in an oral disintegrating tablet (dosage from) for administration to subjects and measured in stability tests (see Table 4.2 and paragraphs (0044], [0073], and [0087] within Zhang ‘114).
Regarding instant claim 63, Espinoza et al., Lefevre et al., and Zhang ‘114 teach wherein the degradant has a degradation rate of about 2.2 x10-3%. Espinoza et al. does not disclose wherein the degradant has a degradation rate of about 2.2 x 10 to the -3 power percent. However, it would been obvious to a person skilled in the art prior to the effective filing date of the claimed invention to determine wherein the degradant has a degradation rate of about 2.2 x 10 to the -3 power percent by routine experimentation in order to fully characterize the stability of the degradant of a prodrug of epinephrine in the course of development and commercialization.
Regarding instant claims 64-66, Espinoza et al., Lefevre et al., and Zhang ‘114 teach wherein the degradant maintains a shelf life for storage at 25°C for the required time. Espinoza et al. does not disclose wherein the degradant maintains a shelf life for storage at 25 degrees Celsius for the required time. However, it would been obvious to a person skilled in the art prior to the effective filing date of the claimed invention to determine wherein the degradant maintains a shelf life for storage at 25 degrees Celsius for the required time by routine experimentation in order to fully characterize the stability of the degradant of the prodrug of epinephrine in the course of development and commercialization.
Regarding instant claims 67-68, Espinoza et al., Lefevre et al., and Zhang ‘114 teach wherein the rate of degradant growth is substantially unchanged for the required time period. Espinoza et al. does not disclose wherein the rate of degradant growth is substantially unchanged for the required time period. However, it would been obvious to a person skilled in the art prior to the effective filing date of the claimed invention to determine wherein the rate of degradant growth is substantially unchanged for the required time period by routine experimentation in order to fully characterize the stability of the degradant of a prod rug of epinephrine in the course of development and commercialization.
Analogous Art
The Espinoza et al., Lefevre et al., Zhang et al. ‘114, Scaberi et al., Schobel et al., Hilliard et al., Yang et al., Zhang et al., Reents et al., Myers et al. ‘825, Sournac et al., Kaur, and Myers et al. references are directed to the same field of endeavor as the instant claims, that is, a pharmaceutical composition with enhanced dissolution disclosed within instant claim 1.
Obviousness Analysis
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify a pharmaceutical composition with enhanced dissolution disclosed by Espinoza et al., using the teachings of Lefevre et al., Zhang et al. ‘114, Scaberi et al., Schobel et al., and Hilliard et al. and further in light of the claim-specific features described in Yang et al., Zhang et al., Reents et al., Myers et al. ‘825, Sournac et al., Kaur, and Myers et al. in order to arrive at the subject matter of the instant claims.
The Espinoza et al., Lefevre et al., Zhang et al. ‘114, Scaberi et al., Schobel et al., Hilliard et al., Yang et al., Zhang et al., Reents et al., Myers et al. ‘825, Sournac et al., Kaur, and Myers et al. references all have considerable overlap for a pharmaceutical composition with enhanced dissolution. In this instance, Espinoza et al., Lefevre et al., Zhang et al. ‘114, Scaberi et al., Schobel et al., and Hilliard et al. supply the bulk of the claim limitations for a pharmaceutical composition with enhanced dissolution, while Yang et al., Zhang et al., Reents et al., Myers et al. ‘825, Sournac et al., Kaur, and Myers et al. supplies specific examples within the instant claims. All references are directed to the preparation and use of a pharmaceutical composition with enhanced dissolution and therefore constitute analogous art under MPEP §2141.01(a). A POSITA would have reasonably consulted the thirteen references when seeking to develop a pharmaceutical composition with enhanced dissolution.
Starting with Espinoza et al., the skilled person only had to try the necessary claim limitations disclosed by Lefevre et al., Zhang et al. ‘114, Scaberi et al., Schobel et al., Hilliard et al., Yang et al., Zhang et al., Reents et al., Myers et al. ‘825, Sournac et al., Kaur, and Myers et al. The combination of Espinoza et al., Lefevre et al., Zhang et al. ‘114, Scaberi et al., Schobel et al., Hilliard et al., Yang et al., Zhang et al., Reents et al., Myers et al. ‘825, Sournac et al., Kaur, and Myers et al. would allow one to arrive at the present application without employing inventive skill. This combination of the pharmaceutical composition with enhanced dissolution taught by Espinoza et al. along with the use of the necessary claim limitations taught by Lefevre et al., Zhang et al. ‘114, Scaberi et al., Schobel et al., Hilliard et al., Yang et al., Zhang et al., Reents et al., Myers et al. ‘825, Sournac et al., Kaur, and Myers et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the pharmaceutical composition with enhanced dissolution disclosed by Espinoza et al. with the use of the necessary claim limitations taught by Lefevre et al., Zhang et al. ‘114, Scaberi et al., Schobel et al., Hilliard et al., Yang et al., Zhang et al., Reents et al., Myers et al. ‘825, Sournac et al., Kaur, and Myers et al. Incorporating the disclosure of Espinoza et al. into the a pharmaceutical composition with enhanced dissolution claim limitations taught by Lefevre et al., Zhang et al. ‘114, Scaberi et al., Schobel et al., Hilliard et al., Yang et al., Zhang et al., Reents et al., Myers et al. ‘825, Sournac et al., Kaur, and Myers et al. represents a predictable use of prior art elements according to their established functions, consistent with MPEP §2143 and KSR.
Furthermore, the additional claim limitations taught by Lefevre et al., Zhang et al. ‘114, Scaberi et al., Schobel et al., Hilliard et al., Yang et al., Zhang et al., Reents et al., Myers et al. ‘825, Sournac et al., Kaur, and Myers et al. would have been viewed by a POSITA as routine design optimizations or known modifications for a pharmaceutical composition with enhanced dissolution. Implementing these features in Espinoza et al.’s pharmaceutical composition with enhanced dissolution would not require more than ordinary skill or routine experimentation.
Accordingly, the combination of Espinoza et al., supplemented by Lefevre et al., Zhang et al. ‘114, Scaberi et al., Schobel et al., Hilliard et al., Yang et al., Zhang et al., Reents et al., Myers et al. ‘825, Sournac et al., Kaur, and Myers et al. provides all the elements of the claimed invention. The resulting pharmaceutical composition with enhanced dissolution constitutes no more than the predictable outcome of combining familiar prior art components, and therefore the claimed subject matter would have been obvious to a POSITA prior to the effective filing date of the invention.
Conclusion
No claims are allowed.
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/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615