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 without traverse of Group I, claims 41, and 43-66 in the reply filed on 05/28/2026 is acknowledged.
Claim 42 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/28/2026.
A Preliminary amendment was filed 01/05/2024.
Information Disclosure Statement
An information disclosure statement was filed on 05/28/2026.
Specification
The disclosure is objected to because of the following informalities: The specification lacks a “Brief Description of the Drawings”.
Appropriate correction is required.
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 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 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 41, 43-65 are rejected under 35 U.S.C. 103 as being unpatentable over Ignatious et al. (Pub. No.: US 2006/0013869; Pub. Date: Jan. 19, 2006).
Regarding claim 41, 51-59 Ignatious discloses electrospun fibers comprising a drug [0012], wherein the fibers are formed from two or more polymers [0053 - 0058] including bioadhesive polymers such polyvinyl pyrrolidone, ethylcellulose, and Eudragit polymers [0059], wherein the electro spun fiber composition incudes polyethylene oxide as POLYOX WSR 1105 [0079], which according to the Dow product page has a molecular weight of 900.000, and wherein the electrospun composition includes a coating [0062].
Regarding claims 43-50, the solubility’s of the fiber forming polymers, the solubility of the bioadhesives, and the form of the bioadhesive recited in claims although Ignatious do not specifically teach the solubility’s of the polymers and bioadhesive or state of the bioadhesive , the claimed composition of the polymers are bioadhesive are the same as instantly claimed and found in the specification as filed. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Furthermore, the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the composition of the prior art does not possess the same material, structural and steps-like characteristics of the claimed composition. In the absence of evidence to the contrary, the burden is on Applicant to prove that the claimed composition is different from that taught by the prior art and to establish patentable differences. See In re Best 562F .2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2nd 1992 (PTO Bd. Pat. App. & Int. 1989).
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.). MPEP 2112.01 (I).
Regarding claims 46-50, Ignatious discloses wherein solvent systems including water and water miscible organic solvents [0061], wherein the water miscible organic solvent is ethanol [0062]. Ignatious does not disclose the ratio of water to ethanol in the solvent system but suitability ratio may be determined based upon the solubility of the active agent [0061].
Regarding the concentration ranges found in claims 44, 45, 51, 60, and 65, MPEP 2144.05 (II)(A) states:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
Concerning claims 61-63, these claims involve the intended uses of the electrospun fibres produced by the instant method , and do not carry any patentable weight since a product by process is considered a product.
Regarding claim 64, while clobetasol proprionate is not specifically listed by Ignatius et al , Ignatius et al lists non-limiting possible bioactives at [0041] –[0043] which includes NSAIDS. Clobetasol is well known corticosteroid. Therefore it would have been well within the skill of the ordinary practitioner to select clobetasol propionate as a possible bioactive in the instantly claimed composition as taught by Ignatius et al.
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to combine the copolymers of polyvinyl pyrrolidone with Eudragit group of polymers in an electorspun fiber further comprising a drug and the bioadhesive polyethylene oxide as disclosed by Ignatious, as instantly claimed, with a reasonable expectation of success at the time of filing as a matter of design choice. Said design choice amounting to combining prior art elements according to known methods to yield predictable results On of ordinary skill in the art would be motivated to do so and have a reasonable expectation of success because Ignatious had already disclosed an electrospun fibers comprising a dug [0012], wherein the fibers are formed from two or more polymers [0058] preferably polyvinyl pyrrolidone with Eudragit group of polymers [0059], wherein the electro spun fiber composition incudes polyethylene oxide as POLYOX WSR 1105 [0079], and wherein the electrospun composition includes a coating [0062]. It would have only required routine experimentation to modify the electorspun fibers of Ignatious to include two hydrophilic fiber types, a bioadhesive, and a drug as required by the claimed invention.
Therefore, the claimed invention would have been prima facie obvious to one of ordinary skill in the art the time of the invention given the teachings of Ignatius et al.
Conclusion
No claims are allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLOS A AZPURU whose telephone number is (571)272-0588. The examiner can normally be reached 9 am- 3 pm, 4 pm-8pm.
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/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz
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