DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the arguments filed on 10/2/2025.
Claims 79-91 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments
Applicant’s response filed 10/2/2025 does not traverse the rejection of claims 79-83 and 87-91 made by the Examiner under non-statutory Double Patenting. This rejection is MAINTAINED for the reason of record in the office action mailed on 6/23/2025.
Applicant’s arguments filed 10/2/2025 regarding the rejection of claims 79-91 made by the Examiner under 35 USC 103 over Scheibel et al. (US 2009/0263430) in view of Stopek et al. (US 2012/0095418) and Voight et al. (US 2014/0114241) have been fully considered but are not found persuasive and is MAINTAINED for the reason of record in the office action mailed on 6/23/2025.
In response to the 103 rejection, Applicant asserts the following:
Stopek effectively teaches away from a dip coating and thus the formation of a complete and continuous covering. Moreover, Voight’s dip coating is intended to be dissolvable rapid release not for slowing or controlling the release.
In response to A, Scheibel describes the following multilayer silk film of the following generic structure:
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(see Figure 6). Scheibel teaches that their silk films can be sustained release (see [0057, 0088]). Stopek teaches a controlled release product wherein release rates may be modulated by inclusion of therapeutic agent in the coating layer and/or the thickness of the films. The coating that is responsible for providing controlled release is to be applied to an active layer by either dip or spray coating Figure 4B exemplifies such a structure:
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wherein layer 42 comprises a drug substance and is coated on a top, base and side by a layer 44 (a hydrophobic polymer). It is taught that hydrophobic outer layer is provided to serve as a barrier to sustain release (see [0006]). Voight is also directed to controlled release film compositions wherein an outer controlled release layer is provided by spray and/or dip coating. Thus, the selection of how a film layer is provided on Scheibel’s silk film formulation is an obvious manipulation of the base teaching and one of ordinary skill in the art would readily envisage providing an outer sustained release coating by application via dip coating.
Regarding the argument that Voight teaches the spray coated layer as being critical to rapid release and not sustained release is not considered persuasive. Voight’s general teaching is to sustained release products. Voight teaches a drug’s release may be controlled by providing a coating of the drug layer by depositing at least one polyelectrolyte bilayer (see [0027]). It is taught that sustained release properties, e.g. release rate, are controlled by the selection of the polyelectrolyte and/or number of layers applied to the surface. The Examiner does not find Voight to be directed to rapid release coatings but rather sustained release coating provided by the application of polyelectrolyte to a surface by a method of spray or dip coating. Such techniques would have been obvious in modifying Scheibel and Stopek (which also teaches coating via spray and dip processes).
Maintained Rejections, of Record
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.
Claims 79-91 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scheibel et al. (US 2009/0263430; of record) in view of Stopek et al. (US 2012/0095418; of record) and Voigt et al. (US 2014/0114241)
Scheibel describes a multilayer silk film comprising one or more agents incorporated therein (see [0047]). The multilayer film is produced via a) providing one or more solutions of silk proteins dissolved or suspended in a suitable solvent; [0014] b) forming one of said solutions into a film; [0015] c) evaporating the solvent, thereby forming a first silk protein film layer; and [0016] d) once or more repeating steps a)-c) to form additional silk protein film layers on said first silk protein film layer in order to form a multilayer silk protein film (see [0012]). Thus, Scheibel describes a multilayer film which possesses a top surface (first layer) and a base surface (second layer) which are opposed to each other wherein each of the top and base surfaces have a side surface which connects the two (see instant claims 79(i), 81). The multilayer may comprise additional silk layers so as to modulate the release of the active agent from the silk film (i.e. sustained release) (see [0018, 0050]).
The composition of Scheibel is to be a standalone multilayer silk film composition which is interpreted as a self-supporting silk film without a carrier element (see example 1, [0073]) (see instant claim 80).
The active agent incorporated in the multilayer film may be a pharmaceutical agent (see [0047]) (see instant claims 82 and 90) or a cosmetic agent (see [0057]) (see instant claim 91).
Scheibel’s multilayered silk film may include silk polypeptides (see [0003]) where the polypeptides impart some desirable feature such as anti-fouling, biocompatibility, and biodegradability (see instant claims 83).
Scheibel states that the films of their multilayer film are to be homogenous (see [0020]) (see instant claims 87-89).
As spider silk is identified as a source of silk for use in the multilayered film composition, it would be a reasonable and obvious modification to use spider silk as a source of the silk polypeptide (see instant claim 84). Moreover, Scheibel sets forth the desirability of including the polypeptide in the multilayer film so it would have been an obvious modification to incorporate the silk polypeptide in to each layer of the multilayer film with a reasonable expectation for success in imparting the benefits of doing so, e.g. biocompatibility, etc.
Scheibel fails to teach their release modifying layer as covering the top surface, the base surface and the at least one side surface of the active agent release sheet.
Stopek teaches a self-supporting multilayer film wherein the film comprises a first layer of hydrophobic polymer, a second layer of hydrophobic polymer and water-soluble therapeutic agent and a third layer of a third hydrophobic polymer wherein the hydrophobic polymers may be the same or different (see [0010]). A contemplated polymer for use in the structure includes silk (see [0050]). The films construct may control parameters such as drug release and diffusion wherein the layer containing the therapeutic does not extend to the edge of the multilayer film (see [0041]) thereby creating a pouch type structure. Sustained release may be provided according to structure of Figure 4B:
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wherein controlled release layers 44 and 40 are provided around the therapeutic containing second layer (see [0085]). The coating layer is applied via spray coating.
Scheibel and Topek fails to teach the release modifying layer as being applied via dip coating.
Although the means by which the coating is applied is a product-by-process limitation and is not seen as providing a substantial distinction over a dip coated surface, see MPEP 2113(I), the means of providing a dip coated control release layer onto a surface is described as interchangeable with by spray coatings. Voigt teaches that controlled release layers can be applied to a surface via spray and/or dip coating (see [0047]). Thus, it would be reasonably expected that the coating of Schiebel and Stoped itself would exhibit controlled release properties and in the case that it did not the application of the coating layer by dip coating would have been an obvious variation to the spray technique taught by the references. See MPEP 2144.06(II) and 2143(I)(B), both of which generally states that the simple substitution of a known element (dip coating) for another (spray coating) to obtain predictable results indica of obviousness.
Thus, it would have been obvious to modify Scheibel’s structure such that the active agent containing layer was completely covered (top, bottom, sides) with a controlled release layer rather than partially covered (e.g. top layer) sufficient to provide controlled release of the active agent to the target area. Such a modification of Scheibel’s structure would have been obvious as combining prior art elements according to known methods to yield predictable result (controlled release of an active agent) is supportive of such a conclusion. See MPEP 2143(I)(A).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 79-91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11324852.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the reference document and the instant claims are directed to the same subject matter. The reference patent document describes a coated silk film consisting of one silk layer film comprising at least one active agent with a molecular weight between 50 Da to 150kDa and having a top surface, a bottom surface, and two side surfaces; and (ii) one release modifying layer completely and continuously covering all surfaces of the silk film layer, wherein the coated silk film is made by first casting a silk film layer with a first silk polypeptide solution comprising the at least one active agent and drying the silk film layer, and then coating the silk film layer with a second silk polypeptide solution to form a release modifying layer completely and continuously covering all surfaces of the silk film layer, wherein each of the first and second silk polypeptide solutions is a 1-10% w/v silk polypeptide solution, and wherein each of the first and second silk polypeptides is C16.
However, the instant invention claims a coated silk film comprising (i) an active agent release sheet which comprises one or more first silk film layers comprising at least one active agent, wherein the active agent release sheet comprises (1) a top surface and a base surface, which are opposed to each other, and (2) at least one side surface connecting the top and the base surfaces, and (ii) one or more release modifying layers completely covering the active agent release sheet (see instant claim 1) wherein the active agent may have a molecular weight of between 50 Da to 150 kDa (see [0080]) wherein the first and second silk polypeptide solution is between 1-10% and the silk polypeptide is C16 (see [0017]).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611