Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/23/2026 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 220-226, 230-233, 235-241, 245-248 and 250-257 is/are rejected under 35 U.S.C. 103 as being unpatentable over yang et al. (20030107149) in view of Flackett (US 2003/0198126) and further in view of Xu (20110104285 equivalent to RU 2010112483) and Dnyaneshwar et al. (ORODISPERSIBLE FILM DOSAGE FORM: A REVIEW).
Yang et al. teach a rapidly dissolving films and methods of their preparation. The films may also contain
an active ingredient that is evenly distributed throughout the film. The even or uniform distribution is
achieved by controlling one or more parameters, and particularly the drying process that reduces
aggregation or conglomeration of the components in the film as it forms into a solid structure. See Para
[0001]. Yang et al. teach a film and a method of forming same which can be divided into equally sized
dosage units having substantially equal amounts of each compositional component present. This
advantage is particularly useful because it permits large area films to be initially formed, and
subsequently cut into individual dosage units without concern for whether each unit is compositionally
equal. For example, the films of the present invention have particular applicability as pharmaceutical
dosage delivery systems because each dosage unit, e.g., each individual dosage film unit, will contain the
proper amount of drug. See Para [0013]. Yang et al. further teach another aspect of the present
invention provides a method of preparing a dosage form for the administration of an active including
the steps of:
(a) combining a polymer, an active component, and water to form a material with a non-self-
aggregating uniform heterogeneity;
(b) forming the material into a film;
(c) applying the film to a substantially non-water soluble support; and (d) drying the film in a controlled
manner to maintain the non-self-aggregating uniform heterogeneity. See Paras [0035]-0039]. The
mixing of polymer, the additives and the drug is taught in Para [0079]. Yang et al. teach that the polymer may be water soluble, water insoluble, or a combination of one or more either water soluble or
water insoluble polymers. The polymer may include cellulose or a cellulose derivative. Specific examples of useful water soluble polymers include, but are not limited to, pullulan, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinyl pyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium alginate, polyethylene glycol, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methyl methacrylate copolymer, carboxyvinyl copolymers, starch, and combinations thereof. Specific examples of useful water insoluble polymers include, but are not limited to, ethyl cellulose, hydroxypropyl ethyl cellulose, cellulose acetate phthalate, hydroxypropyl methyl cellulose phthalate and combinations thereof. See Para [0083]. Yang teaches that the polymer plays an important role in affecting the viscosity of the film. Viscosity is one property of a liquid that controls the stability of the active in an emulsion, a colloid or a suspension. Generally the viscosity of the matrix will vary from about 400 cps to about 100,000 cps, preferably from about 800 cps to about 60,000 cps, and most preferably from about 1,000 cps to about 40,000 cps. Desirably, the viscosity of the film-forming matrix will rapidly increase upon initiation of the drying process. See Para [0088]. Yang in Para [0077] teach that a number of techniques maybe employed in the mixing stage to prevent bubble inclusions in the final film. To provide a composition mixture with substantially no air bubble formation in the final product, anti-foaming or surface-tension reducing agents are employed.
Additionally, the speed of the mixture is desirably controlled to prevent cavitation of the mixture in a
manner which pulls air into the mix. Finally, air bubble reduction can further be achieved by allowing
the mix to stand for a sufficient time for bubbles to escape prior to drying the film. Yang et al. further
teach that the viscosity may be adjusted based on the selected active depending on the other
components within the matrix. For example, if the component is not soluble within the selected
solvent, a proper viscosity may be selected to prevent the component from settling which would
adversely affect the uniformity of the resulting film. The viscosity may be adjusted in different ways. To increase viscosity of the film matrix, the polymer maybe chosen of a higher molecular weight or
crosslinkers may be added, such as salts of calcium, sodium and potassium. The viscosity may also be
adjusted by adjusting the temperature or by adding a viscosity increasing component. Components that
will increase the viscosity or stabilize the emulsion/suspension include higher molecular weight
polymers and polysaccharides and gums, which include without limitation, alginate, carrageenan,
hydroxypropyl methyl cellulose, locust bean gum, guar gum, xanthan gum, dextran, gum arabic, gellan
gum and combinations thereof. See Para [0089]. The use of plasticizers is taught in Para [0119]. The use
of different pharmaceutical active ingredients is taught in Paras [0099] and [0100]-[0103]. The use of
cosmetic active agents is taught in Para [0106]. The use of the claimed plasticizers are taught in Para
[0123]. Yang et al. teach that the alternative method begins with first combining the ingredients with
mixing. The combination of ingredients is then divided among individual wells or molds. In such a
method, aggregation of the components during drying is prevented by the individual wells. See Para
[0171]. The thickness of the film product is taught in claims 17-18.
Yang et al. differ from the claimed invention in the use of a bladeless planetary mixer for mixing the
ingredients. Flackett teaches a mixing system (mixing system shown in figures 1-4, comprising: a
planetary mixer configured for bladeless mixing (item 10). Xu teaches a bladeless 3 or multidimensional
mixer for preparing a homogenous pharmaceutical formulations. See claims 48 and 49.
It would have been obvious toa person skilled in the art to use a bladeless planetary mixer for
preparation of yang's composition, motivated by the teachings of Flackett and Xu, which teach the use
of bladeless mixer for the preparation of pharmaceutical formulations in order to obtain a
homogeneous formulation as old and well know. The determination of viscosity, the water activity and
volume to use in each mold is considered to be within the skill of artisan in the absence of evidence to
the contrary. The removal of the dosage form from the mold is also considered to be within the skill of
the artisan. The use of a devise for transferring the mixture into the mold is considered to be within the skill of the artisan in the absence of evidence to the contrary. The application of the film to different
parts of the body, specifically dermal administration is taught by Yang. See Para [0i54]. Dnyaneshwar et al. teach an orodispersible dosage form Fast dissolving oral thin film is a solid dosage form, which disintegrate or dissolve within 1 min when placed in the mouth without drinking of
water or chewing. Oral film includes various ingredients for its formulation, which includes polymers, active pharmaceutical ingredient, film stabilizing agents, sweeteners, flavors, colors, saliva stimulating agents, preservatives, surfactants etc., but the first and far most a very essential ingredient which helps in film formation is a Polymer. See the abstract. The addition of active pharmaceutical ingredients is taught in Table 3. Subjecting the mixture to the temperature of 60 C in the solvent casting mixture technique and drying at 60 C is taught on page 1101. Dnyaneshwar et al. also teaches another method of preparing without using any solvent or water. See page 1102. The determination of tensile strength which relates to the stress applied to the point that the film breaks is taught on page 1108. Furthermore, since applicant uses the same method of use and the same components as the prior art, therefore the claimed water activity is the inherent property of the prior art composition.
Response to arguments
Applicant’s arguments have been noted. Applicant in his remarks argues that “The Office responds that "the examiner has relied on the secondary references to show that the use of a bladeless planetary mixer in preparing pharmaceutical formulations as old and well know[n]." OA at p. 2. Emphasis added. But on page 6, the Office also relies on the references for their alleged teachings of obtaining
homogenous formulations: "Flackett and Xu teach the use of bladeless mixer for the preparation of pharmaceutical formulations in order to obtain a homogeneous formulation as old and well know[n]." Id. at p. 6. Emphasis added. Xu, however, relates to an improved process for making a "powder for oral administration" consisting of "granules which are agglomerated particles." See Xu at [0002], [0031]”. It is the examiner's position that Flackett is relied upon to teach a mixing system comprising: a planetary mixer configured for bladeless mixing in preparing pharmaceutical formulations. Xu teaches a bladeless 3 or multidimensional mixer for preparing a homogenous pharmaceutical formulations. Applicant's
attention is drawn to In Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); where the court states "The
test for obviousness is not whether the features of a secondary reference may be bodily incorporated
into the structure of the primary reference Rather, the test is what the combined teachings of those
references would have suggested to those of ordinary skill in the art". In the instant case the examiner
has relied on the secondary references to show that the use of a bladeless planetary mixer in preparing
pharmaceutical formulations as old and well known. Applicant’s arguments regarding the amendments to the specific water activity, length of drying and the average stress break have been noted. It is the examiner’s position that since the prior art uses the same components for preparing a film dosage form as claimed herein with the same process of mixing, drying and molding, therefore, the product of prior art is inherently has the same water activity and stress at break. The only difference between the prior art and the claimed method of preparing is the bladeless planetary mixer, which is taught by the secondary references. The determination of the drying time is considered to be within the skill of artisan, considering that applicant’s claims are very broad and encompass a vast number of ingredients, which a person skilled in the art has to determine the proper length of time for drying of each composition.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617