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
Applicants’ election of Group I (claims 1-14 and 16-20) drawn to an oral thin film, is acknowledged.
Because Applicants 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 § 818.03 (a)).
As the requirement for restriction is deemed proper, it is maintained and hereby made FINAL.
Claim 15 is hereby withdrawn from further consideration by the Examiner, pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. The instant claims have been examined commensurate with the scope of the elected invention. Applicants timely responded to the restriction requirement in the reply filed 4/9/26.
Accordingly, claims 1-14 and 16-20 are under current examination.
Status of Claims
No new claim set was filed in response to the Restriction/Election requirement.
Amended claims
Newly canceled claims
Newly added claims
Previously canceled claims
Instantly withdrawn claims
15
Claims under instant examination
1-14 and 16-20
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.
Claim 7 is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation “comprises at least one hygroscopic additive having more than 3 carbon atoms”, and the claim also recites “preferably selected from sugars, sugar alcohols, starches and starch derivatives, or a mixture thereof” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 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 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.
Claims 1-14 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Muller et al. (US 2020/0138714; published: 5/7/20), in view of Edwards (US 2020/0155447; published: 5/21/20).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Muller is directed to quickly disintegrating foam wafer with high mass per unit area [Title].
With regards to instant claims 1-3, 6, 16 and 19, Muller teaches a planar dosage form (e.g., wafer) that disintegrates or dissolves in an aqueous environment for releasing at least one active ingredient in a body orifice or body cavity, wherein the dosage form comprises a polymer matrix and at least one pharmaceutical active ingredient and wherein the polymer matrix is based on a polymer such as polyvinyl alcohol [claims 1 and 3]. Wu teaches a very especially well-suited polyvinyl alcohol has a weight average molecular weight in the range of 15,000-60,000 and especially in the range of 25,000-50,000 (e.g., Mowiol 4-88, which has a MW of 31,000 Da) (i.e., the claimed at least one polyvinyl alcohol having a lower average molecular weight with overlapping ranges) [0020]. As indicated in Example 1, polyvinyl alcohol (Mowiol 4-88) is present in an amount of 38.00% by weight. Muller teaches that the active ingredient can range from 20-60% by weight, based on the dry weight of the dosage form [0037]. It is noted that instant claims 2, 6 and 16 only requires the narrowing molecular range of one of the two claimed polyvinyl alcohols due to the “and/or” language.
With regards to instant claims 7-9, Muller teaches a sugar (e.g., mannitol, sorbitol, xylitol, maltitol, maltodextrin, glycose syrup (from corn) and soluble starches) or a mixture of sugars or another carbohydrate material may be dissolved in the foam, and such increases the mass of the foam after drying and provides additional strength, stability and sweet taste) [0057]. Muller teaches that such additives should like in the range of 0.01-10% (i.e., overlapping ranges) by weight, based on the dry weight of the dosage form [0058]
With regards to instant claims 10 and 20, Muller teaches wherein the pharmaceutical active ingredient comprises ketamine [claims 9 and 18].
With regards to instant claim 11, Muller teaches wherein the pharmaceutical active ingredient accounts for a proportion in the range of 38-60% by weight, based on the total weight of the dosage form [claim 10].
With regards to instant claim 12, Muller teaches wherein the dosage form contains a taste-masking constituent [claim 11].
With regards to instant claim 13, Muller teaches wherein the polymer matrix is in the form of a solidified foam having cavities [claim 1].
With regards to instant claims 14 and 19, Muller teaches wherein the dosage form has a mass per unit area in the range of 150-220 g/m2 [claim 214-88].
With regards to claim 20, Muller teaches wherein plasticizers may also be added to the dosage form in order to improve the aesthetic properties of the dried foam and reduce the fragility or brittleness of the dried foam; such agents include glycerol, propylene glycol and polyglycerol ester [0051].
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Although Muller teaches the incorporation of polyvinyl alcohol and specifically the claimed “at least one polyvinyl alcohol having a lower average molecular weight of 10,000 to about 75,000 g/mol”, Muller does not teach further incorporating a second polyvinyl alcohol having a lower average molecular weight of 140,000 to about 300,000 g/mol, as required by instant claim 1. Also, Muller does not teach wherein the first polyvinyl alcohol with lower MW and the second polyvinyl alcohol with higher MW have a weight ratio in the claimed film in the range of 15:1 to 3:1 or from 9:1 to 7:1, as required by instant claims 4 and 17, respectively. Muller does not teach wherein the second polyvinyl alcohol with higher MW is present in the matrix layer in the range from 1-18 wt% or 3-4 wt%, based on the total weight of the matrix layer, as required by instant claims 5 and 18, respectively. However, this deficiency is cured by Edwards.
Edwards is directed to adherent oral pharmabiotic delivery strip [Title].
Edwards teaches the use of natural gums and other natural ingredients, the making of oral dissolving strips may include the use of biocompatible synthetic polymners, lipids, fats and waxes, to improve the strip-making process [0047]. Exemplary biocompatible ingredients include polyvinyl alcohol of varying molecular weights, viscosities, and hydrolysis (to fabricate quicker-drying thinner strips without being too viscous to achieve better intraoral time release, intraoral extended release, and lowered water solubility) [0047].
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Muller and Edwards are both directed to oral film compositions comprising an active ingredient. Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, before the invention was effectively filed, to modify the film of Muller by further incorporating a second polyvinyl alcohol with a higher molecular weight to achieve the predictable result of obtaining a composition suitable for delivering an active ingredient upon oral administration. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). See MPEP 2144.07.
The amount of polyvinyl alcohol with higher MW and the weight ratio of the polyvinyl alcohol with lower MW to the polyvinyl alcohol with higher MW is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount and weight ratio in order to best achieve the desired results as such would advantageously provide optimal quicker-drying, thinner strips without being too viscous, better intraoral time release, intraoral extended release, and lowered water solubility, as taught by Edwards [0047]. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). The Examiner considers it prima facie obvious to optimize the amounts of any biologically active agent to achieve their known biological effect, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the amounts of each polyvinyl alcohol and the weight ratio of the lower MW to higher MW polyvinyl alcohol would impact the speed to dry, viscosity of composition, intraoral time release and water solubility and therefore be an optimizable variable.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/GENEVIEVE S ALLEY/ Primary Examiner, Art Unit 1617
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