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 .
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 31-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No.11,976,196. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 31, all of the limitations of the claim are required by claim 1 of the reference patent.
Regarding claim 32, all of the limitations of the claim are required by claim 2 of the reference patent.
Regarding claim 33, all of the limitations of the claim are required by claim 3 of the reference patent.
Regarding claim 34, all of the limitations of the claim are required by claim 4 of the reference patent.
Regarding claim 35, all of the limitations of the claim are required by claim 5 of the reference patent.
Regarding claim 36, all of the limitations of the claim are required by claim 6 of the reference patent.
Regarding claim 37, all of the limitations of the claim are required by claim 7 of the reference patent.
Regarding claim 38, all of the limitations of the claim are required by claim 8 of the reference patent.
Regarding claim 39, all of the limitations of the claim are required by claim 9 of the reference patent.
Regarding claim 40, all of the limitations of the claim are required by claim 10 of the reference patent.
Regarding claim 41, all of the limitations of the claim are required by claim 11 of the reference patent.
Regarding claim 42, all of the limitations of the claim are required by claim 12 of the reference patent.
Regarding claim 43, all of the limitations of the claim are required by claim 13 of the reference patent.
Regarding claim 44, all of the limitations of the claim are required by claim 14 of the reference patent.
Regarding claim 45, all of the limitations of the claim are required by claim 15 of the reference patent.
Regarding claim 46, all of the limitations of the claim are required by claim 16 of the reference patent.
Regarding claim 47, all of the limitations of the claim are required by claim 17 of the reference patent.
Regarding claim 48, all of the limitations of the claim are required by claim 18 of the reference patent.
Regarding claims 49-53, all of the limitations of the claim are required by claim 1 of the reference patent.
Regarding claims 54-56, all of the limitations of the claim are required by claim 15 of the reference patent.
Regarding claim 57, claim 15 of the reference patent teaches all of the limitations of claim 45, on which claim 57 depends. Furthermore, claim 1 of the reference patent teaches that the coating may possess the claimed crystallinity characteristics.
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.
Claims 36 and 42 are 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.
Regarding claim 36, the claimed listing of “insects” includes organisms which are not insects, including Araneus cavaticus, Eurprosthenops asutralis, Nephila madagascarensis, Nephila clavipes, and Tetragantha versicolor (spiders), and Pinna Squamosa (a mollusc). One having ordinary skill in the art would therefore be unable to determine if the listed non-insect sources of silk proteins are included within the claimed packaging product.
The applicant may overcome this rejection by amending claim 36 to remove the mention of insects therefrom, e.g. “… one or more
Regarding claim 42, The term “highly basic” in line 3 is a relative term which renders the claim indefinite. The term “highly basic” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The amount of alkalinity within the claimed solution has been rendered indefinite by the use of said term.
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.
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.
Claims 31, 34, 36-39, 41-44, and 46-53 are rejected under 35 U.S.C. 103 as being unpatentable over Omenetto (WO 2015/134865) in view of Behrens (US 2020/0178576 A1).
Regarding claim 31, Omenetto teaches biopolymer coatings and products incorporating such coatings (Abstract) for the purpose of preserving perishable goods such as foodstuffs ([0002], [0005]). Omenetto teaches that the biopolymer coatings are made of protein-based materials ([0030]), and specifically points out silk fibroin as a suitable example for the inventive coating ([0043] and [0048]). Omenetto specifies that the inventive biopolymer coatings are prepared as aqueous solutions ([0092]), and teaches the application by coating ([0094]). Importantly, while the majority of the disclosure of Omenetto focuses on the direct application of the inventive biopolymers to food products (e.g., [0010]), Omenetto specifically mentions that the inventive coatings may also be applied to surfaces of packaging materials ([0107]). Patents are relevant for all of the information they contain and non-preferred and alternative embodiments nonetheless constitute prior art (see MPEP 2123.I and II). The packaging material(s) containing surfaces coated with the biopolymer of Omenetto therefore read on the claimed “food-safe packaging product comprising silk protein and a substrate, wherein the substrate is treated with a silk solution comprising silk fibroin and/or silk fibroin and sericin to form a silk coating, wherein the silk solution is applied to the substrate by coating…,” despite the majority of Omenetto’s disclosure being focused on direct application of biopolymer coatings to foodstuffs. Furthermore, Omenetto specifically states that the proteins of the inventive compositions include “fragments” of silk fibroin ([0051]), and teaches that the inventive coatings may significantly extend the shelf-life of perishable products packaged therewith ([0077]). The packaging material(s) containing surfaces coated with the biopolymer of Omenetto therefore read on the claimed limitations requiring extension of shelf-life. It is reasoned that the packaging materials contemplated by Omenetto meet the claimed limitations requiring that food can be held thereby, based on the fact that Omenetto simply calls them packaging materials.
Omenetto teaches that the average molecular weight(s) of the protein(s) within the inventive biopolymer coatings may range from about 50 to about 400 kDa ([0042]) and additionally contemplates that silk fibroin coatings may comprise polypeptides having average molecular weights between about 3.5 and about 350 kDa ([0061]), and teaches that the biopolymer coating solutions typically contain between about 0.1 and about 20 weight % biopolymer concentration ([0092]) but differs from claim 1 because it is silent with regard to the claimed compositional amounts of fragments having the claimed molecular weight ranges, and because it is silent with regard to the claimed concentration of the silk solution in terms of weight/volume percentage.
In the same field of endeavor, Behrens teaches compositions, solutions, and methods for extending the shelf life of food compositions (Abstract), wherein foods and/or compositions are coated with solutions containing silk fibroin (Abstract). Behrens, likewise to Omenetto, teaches that silk fibroin-based coatings are capable of increasing the shelf life of perishable goods ([0004]). Also, likewise to Omenetto, Behrens primarily focuses on the direct application of coatings onto foodstuffs, but mentions the additional suitability for coating substrates ([0002]), and states that substrates may comprise a perishable item (i.e., the substrate may include something else in addition to the perishable item, [0032]). Behrens also contemplates “fragments” of silk fibroin ([0008]).
In addition to the teachings cited above which significantly overlap with the teachings of Omenetto, Behrens teaches that the silk fibroin coating compositions may include up to 25 weight/volume percent of silk fibroin fragments ([0008], [0031]-[0032], and claim 17 on p. 4), and teaches up to 10% of fragments having molecular weights over 400 kDa and up to 45% of the silk fibroin fragments having molecular weights over 300 kDa ([0008], [0031], and claim 17 on p. 4). It is prima facie obvious to substitute equivalents known in the art as suitable for the same purpose (see MPEP 2144.06) and, while Omenetto teaches the typical mass % range of fibroin within the biopolymer solution, Omenetto does not teach away from differing ranges nor disparages ranges calculated as mass/volume percentage. Likewise, Omenetto does not teach away from any particular molecular weight distributions, and teaches that biopolymers may contain molecular weights up to “about” 400 kDa (which is interpreted as including molecular weights somewhat above 400 kDa). Finally, Omenetto teaches silk fibroin fragments have molecular weights ranging from 3.5 to 350 kDa in some embodiments ([0061]), thereby implying that said numbers do not represent strict or rigid molecular weight boundaries. Therefore, it would have been obvious to one having ordinary skill in the art at the time of filing to incorporate the claimed weight/volume silk fibroin concentration and the claimed compositional amounts of fragments having the claimed molecular weight ranges within the composition of Omenetto, as taught by Behrens, as Behrens teaches these ranges as suitable for substantially similar food packaging coatings for perishable food preservation. The ranges taught by Behrens, in each case, encompass/overlap the claimed ranges, establishing prima facie cases of obviousness.
Regarding claim 34, Omenetto teaches that, inter alia, a plasticizer may be further incorporated into the inventive coatings ([0062]).
Regarding claim 36, Omenetto teaches that the silk protein of the inventive composition may be those obtained from, inter alia, Bombyx mori and Nephila clavipes ([0051]-[0052]).
Regarding claim 37, Omenetto teaches the specific incorporation of multiple coatings of the inventive composition ([0094]), which reads on the claimed “further mixing” because said teaching constitutes additional steps (i.e., “further” steps) which combine the coating and the substrate (i.e., “mixing”). Importantly, the instant Specification does not provide a controlling definition for what constitutes “further mixing.” Instead, the instant Specification merely states that mixing is a suitable method for contacting the silk with the substrate ([0054]). Furthermore, the instant Specification provides no controlling definition for “incorporating” the silk protein with the substrate; thus, under the broadest reasonable interpretation, the coating/application of the silk solution onto the substrate reads on “incorporating.”
Regarding claim 38, Omenetto teaches that the coatings are prepared as aqueous solutions ([0092]), which reads on “water” from the claimed list.
Regarding claim 39, Omenetto teaches that the biopolymer coatings may cover “at least a portion of” a perishable product ([0102]). It is prima facie obvious to substitute equivalents known in the art as suitable for the same purpose (see MPEP 2144.06), and as described above, Omenetto teaches that the inventive biopolymer coating may alternatively be applied to surfaces of conventional packaging materials ([0107]). It therefore would have been obvious to one having ordinary skill in the art to coat “at least a portion of” a conventional packaging material with the coating of Omenetto, thereby meeting the claimed limitation.
Regarding claim 41, Omenetto exemplifies the coating of a strawberry with the inventive coating solution multiple times (including 2 and 4 coatings) ([0116]). It is prima facie obvious to substitute equivalents known in the art as suitable for the same purpose (see MPEP 2144.06), and as described above, Omenetto teaches that the inventive biopolymer coating may alternatively be applied to surfaces of conventional packaging materials ([0107]). It therefore would have been obvious to one having ordinary skill in the art to dip-coat surfaces of conventional packaging materials with the coating of Omenetto multiple times, including 2 and 4 coatings, which reads on the claimed limitation requiring that the substrate is “treated” more than once.
Regarding claim 42, the claim is recognized as a product-by-process claim. Product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps (see MPEP 2113.I.). In this case, the instant application makes no mention of any particular structure imparted by the claimed “pre-treatment,” aside from stating that it may optionally be done (see instant Specification at [0077]). Furthermore, the specification specifically states that the basic solutions could simply include water ([0077]), and states that pre-treatment includes leaving the solution to fully dry prior to apply thing the silk solution ([0077]). In circumstances where pre-treatment constitutes a treatment with basic water followed by the drying thereof, there is no articulated structure implied by these steps. Therefore, the coating process of Omenetto meets the limitations of claim 42 despite not contemplating a specific pre-treatment step.
Regarding claim 43, Omenetto teaches that the inventive coatings range from about 0.1 micron and about 1 mm in thickness ([0101]), which encompasses the claimed range of “about 0.1 µm to about 100 µm,” establishing a prima facie case of obviousness.
Regarding claim 44, Omenetto is silent with regard to the claimed limitation requiring no additional steps for recycling beyond those required for the packaging product itself. Nevertheless, Omenetto as applied above results in a coated packaging product which meets all of the claimed limitations, having all of the same components. Products of identical chemical compositions cannot have mutually exclusive properties. Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of obviousness has been established. See MPEP 2112.01. The claimed lack of additional recycling steps will therefore necessarily be present in Omenetto as modified by Behrens, and as applied above.
Regarding claim 46, as described above, Omenetto as modified by Behrens teaches the coating of a conventional packaging material with a silk solution which meets all of the claimed compositional limitations. The coating process therefore reads on the claimed method.
Regarding claim 47, Omenetto teaches spray-coating ([0094]), which reads on the use of a spray device. Omenetto does not require or contemplate partial coating, and teaches dip-coating as an alternative coating method to spraying (which would completely cover a substrate; p. 53, claim 39). The spraying method of Omenetto therefore reads on the claimed limitation requiring spraying the entire surface of the substrate. Omenetto likewise teaches that the inventive silk fibroin membranes are dry (p. 34, [0122]), which implies the incorporation of a drying step, since the silk fibroin is taught as beginning as a solution and forming a final dry film.
Regarding claim 48, as described above, Omenetto teaches the coating of substrates as a direct alternative to coating fruits and vegetable products. Omenetto additionally exemplifies a dip coating process, wherein strawberries are completely submerged in a silk fibroin solution (a 60 mm-deep solution, which must be contained in a container by virtue of said depth) for 10 seconds, followed by hanging and drying for four hours ([0118]). In this case, the hanging of Omenetto reads on the claimed shaking step, as hanging the coated fruit will cause excess material to drain therefrom while drying. The process of Omenetto therefore reads on the claimed process. Omenetto teaches values of dip time and drying time which fall within their respectively claimed ranges, establishing prima facie cases of obviousness.
Regarding claims 49-51, Omenetto as modified is silent with regard to the claimed OTR, WVTR, and crystallinity characteristics. Nevertheless, Omenetto as modified and as applied above results in a coated packaging product which meets all of the claimed limitations, having all of the same components. Products of identical chemical compositions cannot have mutually exclusive properties. Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of obviousness has been established. See MPEP 2112.01. The claimed OTR, WVTR, and crystallinity characteristics will therefore necessarily be present in Omenetto as modified by Behrens, and as applied above. Importantly, Omenetto specifically teaches that so-called “amorphous” silk fibroin coatings, which result from the dried solution, are not actually amorphous but contain crystallinity (evaluated as about 23% in at least one instance, see [0134], Table 3).
Regarding claim 52, Omenetto specifically contemplates water annealing of the coating (e.g., [0134]); however, Omenetto specifically teaches multiple instances where fruits are not water annealed (e.g., fig. 8, Sheet 8/10 shows an improvement in weight retention of strawberries which have been coated in the silk fibroin solution but which have not been water-annealed, versus uncoated strawberries. See also [0021] where Omenetto specifically states that strawberries coated with the amorphous (non-annealed) silk retained more water than the no-coating controls at day 3). As described above, Omenetto teaches the application of the inventive coating to food packaging substrates in addition to direct application to foodstuffs. It is prima facie obvious to substitute equivalents known in the art as suitable for the same purpose (see MPEP 2144.06).Therefore, it would have been obvious to one having ordinary skill in the art to produce a non-annealed silk coating on a packaging substrate from the teachings of Omenetto, as Omenetto teaches the usefulness of non-annealed fruit coatings and specifically states that said coatings are alternatively suitable for packaging substrates.
Regarding claim 53, Omenetto is silent with regard to the recyclability or compostability of the coated substrate. Nevertheless, Omenetto as applied above results in a coated packaging product which meets all of the claimed limitations, having all of the same components. Products of identical chemical compositions cannot have mutually exclusive properties. Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of obviousness has been established. See MPEP 2112.01. The claimed compostability/recyclability characteristic will therefore necessarily be present in Omenetto as modified, as applied above.
Claims 32-33 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Omenetto (WO 2015/134865) in view of Behrens (US 2020/0178576 A1) and further in view of Oshita (US 2009/0297741 A1).
Regarding claims 32-33, and 35, Omenetto as modified by Behrens teaches all of the limitations of claim 31, as described above. Omenetto as modified by Behrens differs from claims 32-33 and 35 because it is silent with regard to the particularly claimed types of packaging substrates.
In the same field of endeavor, Oshita teaches a paper container that allows the food contents therein to be checked, and which prevents the same from deteriorating for a long period of time (Abstract). Oshita specifically contemplates coating the paper surfaces of the containers (e.g., [0204]), and particularly contemplates the value of excellent barrier properties such as OTR and WVTR ([0217]), likewise to Omenetto (e.g., [0068]). The coatings within Oshita specifically include inter alia pouches ([0218], [0224] and Sheet 6/6, Figures 7 and 8) and films ([0063]).
Omenetto places no restrictions on the type of food packaging substrate which may be coated by the inventive silk fibroin solution, and it is prima facie obvious to substitute equivalents known in the art as suitable for their intended use (See MPEP 2144.06). Therefore, it would have been obvious to one having ordinary skill in the art at the time of filing to coat the silk fibroin solution of Omenetto as modified by Behrens onto the substrates of Oshita, as Oshita contemplates said substrates as coat-able food packaging substrates having excellency in the same barrier properties which Omenetto specifically contemplates relating to food preservation.
Claims 40, 45, and 54-57 are rejected under 35 U.S.C. 103 as being unpatentable over Omenetto (WO 2015/134865) in view of Behrens (US 2020/0178576 A1) and Oshita (US 2009/0297741 A1), and further in view of Santos (WO 2020/247594).
Regarding claim 40, Omenetto as modified by Behrens teaches all of the limitations of claim 31, as described above. Omenetto as modified by Behrens differs from claim 40 because it is silent with regard to the incorporation of a window within the packaging product which is formed of partially transparent silk.
As described above, it would have been obvious to one having ordinary skill in the art at the time of filing to coat the silk fibroin solution of Omenetto as modified by Behrens onto the substrates of Oshita, as Oshita contemplates said substrates as coat-able food packaging substrates having excellency in the same barrier properties which Omenetto specifically contemplates relating to food preservation; however, while Oshita contemplates a window within the inventive food packaging ([0001]), Oshita is silent with regard to said film being formed from silk.
In the same field of endeavor, Santos teaches silk-based products and their use in a variety of fields (Abstract). Santos teaches that silk fibroin can be prepared as films or mats by casting an aqueous solution into different shapes and molds, followed by allowing the solution to dry or evaporate ([0739]). Santos teaches that the resulting film is transparent ([0739]) and specifically states that the inventive silk fibroin solids can be used as a substitute for petroleum-based products in the manufacture of a variety of consumer products including food-related and/or packaging materials, such as bags, food covering films, trays, containers, etc. ([0763]). Meanwhile, Oshita contemplates that the inventive food packaging window may be formed from common petrochemical sources such as polyethylene ([0057]). It is prima facie obvious to substitute equivalents known in the art as suitable for the same purpose (see MPEP 2144.06). Therefore, it would have been obvious to one having ordinary skill in the art at the time of filing to utilize the transparent silk film of Santos within the packaging of Oshita, as Santos teaches said film as a suitable alternative to petrochemically-sourced materials in, inter alia, food packaging-based applications. The resulting composition of Omenetto, Behrens, Oshita, and Santos meets all of the claimed limitations.
Regarding claim 45, as described above, Omenetto as modified by Behrens teaches the coating of the inventive silk fibroin solution to a substrate, wherein the silk fibroin solution contains silk fibers and water (a solvent, [0092]), and meets all of the claimed compositional limitations including the silk fibroin fragments’ molecular weight distribution. Furthermore, as described above, it would have been obvious to one having ordinary skill in the art at the time of filing to apply said coating to the food packaging substrates within Oshita, which includes paper-comprising materials and substrates having a window, and it would have been obvious for said window to be formed from silk fibroin according to Santos. Finally, Omenetto teaches that the films formed from the inventive silk solution may range from about 0.1 to about 1000 microns ([0101]), including the sub-range of up to 100 microns ([0101]). These ranges encompass/are identical to the claimed range of “0.1 µm to 100 µm,” establishing a prima facie case of obviousness.
Regarding claim 54, as described above, Omenetto teaches that the inventive silk solution is aqueous ([0048]), and therefore contains water as a solvent.
Regarding claims 55-57, Omenetto as modified is silent with regard to the claimed OTR, WVTR, and crystallinity characteristics; Nevertheless, Omenetto as modified and as applied above results in a coated packaging product which meets all of the claimed limitations, having all of the same components. Products of identical chemical compositions cannot have mutually exclusive properties. Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of obviousness has been established. See MPEP 2112.01. The claimed OTR, WVTR, and crystallinity characteristics will therefore necessarily be present in Omenetto as modified by Behrens, Oshita, and Santos, and as applied above. Importantly, Omenetto specifically teaches that so-called “amorphous” silk fibroin coatings, which result from the dried solution, are not actually amorphous but contain crystallinity (evaluated as about 23% in at least one instance, see [0134], Table 3).
Conclusion
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/JOSHUA CALEB BLEDSOE/Examiner, Art Unit 1762
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