DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s election without traverse of Group I, claims 1-10 and 18-20, in the reply filed on October 22, 2025 is acknowledged. Claims 1-10 and 12-21 are pending of which claims 12-17 and 21 are withdrawn and claims 1-10 and 18-20 are now under consideration.
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.
3. Claims 1-10 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Petisce et al. (US 2006/0229512 A1).
Petisce et al. disclose devices for measuring glucose in a host wherein the devices incorporate a cellulosic-based interference domain. In one embodiment, the interference domain is formed from one or more cellulosic derivatives. In general, cellulosic derivatives include polymers such as cellulose acetate, cellulose acetate butyrate, 2-hydroxyethyl cellulose, cellulose acetate phthalate, cellulose acetate propionate, cellulose acetate trimellitate, and the like. In one preferred embodiment, the interference domain is formed from cellulose acetate butyrate (equivalent to the cellulose ester and the film-forming material of the claimed invention and meeting the limitations of claims 2 and 3). Cellulose acetate butyrate with a molecular weight of about 10,000 daltons to about 75,000 daltons, preferably from about 15,000, 20,000, or 25,000 daltons to about 50,000, 55,000, 60,000, 65,000, or 70,000 daltons (meeting the limitations of claims 5, 7, and 19), and more preferably about 20,000 daltons is employed. In certain embodiments, however, higher or lower molecular weights can be preferred. Additionally, a casting solution or dispersion of cellulose acetate butyrate (equivalent to the composition of the claimed invention) at a weight percent of about 15% to about 25%, preferably from about 15%, 16%, 17%, 18%, 19% to about 20%, 21%, 22%, 23%, 24% or 25%, and more preferably about 18% is preferred. It can be desirable to employ a mixture of cellulose acetate butyrate components with different molecular weights in a single solution, or to deposit multiple layers of cellulose acetate butyrate from different solutions comprising cellulose acetate butyrate of different molecular weights, different concentrations, and/or different chemistries (e.g., functional groups) and to include additional substances in the casting solutions or dispersions, e.g., functionalizing agents, crosslinking agents, other polymeric substances, substances capable of modifying the hydrophilicity/hydrophobicity of the resulting layer, and the like. In one alternative embodiment, the interference domain 48 is formed from cellulose acetate. Cellulose acetate with a molecular weight of about 30,000 daltons or less to about 100,000 daltons or more, preferably from about 35,000, 40,000, or 45,000 daltons to about 55,000, 60,000, 65,000, 70,000, 75,000, 80,000, 85,000, 90,000, or 95,000 daltons, and more preferably about 50,000 daltons is preferred. Additionally, a casting solution or dispersion of cellulose acetate at a weight percent of about 3% to about 10%, preferably from about 3.5%, 4.0%, 4.5%, 5.0%, 5.5%, 6.0%, or 6.5% to about 7.5%, 8.0%, 8.5%, 9.0%, or 9.5%, and more preferably about 8% is preferred. In certain embodiments, however, higher or lower molecular weights and/or cellulose acetate weight percentages can be preferred. It can be desirable to employ a mixture of cellulose acetates with molecular weights in a single solution, or to deposit multiple layers of cellulose acetate from different solutions comprising cellulose acetates of different molecular weights, different concentrations, or different chemistries (e.g., functional groups). Layer(s) prepared from combinations of cellulose acetate and cellulose acetate butyrate (meeting the limitations of claims 8, 10, and 18), or combinations of layer(s) of cellulose acetate and layer(s) of cellulose acetate butyrate can also be employed to form the interference domain. In some alternative embodiments, more than one cellulosic derivative can be used to form the interference domain 48 of the preferred embodiments. In general, the formation of the interference domain on a surface utilizes a solvent or solvent system in order to solvate the cellulosic derivative (or other polymer) prior to film formation thereon. However, a percent solute of from about 1% to about 25% is preferably used to form the interference domain solution so as to yield an interference domain having the desired properties. The cellulosic derivative (or other polymer) used, its molecular weight, method of deposition, and desired thickness can be adjusted, depending upon one or more other of the parameters, and can be varied accordingly. In some alternative embodiments, other polymer types that can be utilized as a base material for the interference domain include polyurethanes, polymers having pendant ionic groups, and polymers having controlled pore size, for example. In one such alternative embodiment, the interference domain includes a thin, hydrophobic membrane that is non-swellable and restricts diffusion of low molecular weight species. The interference domain is permeable to relatively low molecular weight substances, such as hydrogen peroxide, but restricts the passage of higher molecular weight substances, including glucose and ascorbic acid. (See Abstract and paragraphs 0228-0239).
With regards to the limitation that the cellulose ester and the further film-forming material are present in the composition at a ratio of in the range 0.1 : 1 to 10: 1 by weight, the free hydroxyl groups of the cellulose ester are present in an amount of in the range 15 to 40 mol%, and the cellulose ester comprises butyl substituents in an amount of in the range 65 to 75 mol%, and acetyl substituents in an amount of in the range 2 to 5 mol%, the Examiner takes the position that the that workable physical properties and concentrations are deemed to be obvious routine optimizations to one of ordinary skill in the art, motivated by the desire to obtain the required properties particularly given that Petisce et al. specifically states that a mixture of cellulose acetates with different molecular weights, different concentrations, or different chemistries (e.g., functional groups) can be employed to modify the hydrophilicity/hydrophobicity of the resulting layer.
With regards to the limitation that the film-forming material is selected such that, when the composition is dissolved in ethylene glycol diacetate, the resultant solution has a viscosity of less than or equal to 7500 mPa.s as measured at a temperature of 22 + 1 °C using a Brookfield viscometer operating at a spindle speed of 60 rpm, the Examiner takes the position that such a property limitation is inherent in the cellulose acetate butyrate (as the film-forming material in the mixture of cellulose acetate butyrate components) given that the film-forming material as taught by Petisce et al. and that of the claimed invention are identical.
Conclusion
4. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEEBA AHMED whose telephone number is (571)272-1504. The examiner can normally be reached Monday-Thursday 7am-6pm.
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/SHEEBA AHMED/Primary Examiner, Art Unit 1787