DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt of the Request for Continued Examination (RCE under 37 CFR 1.114), the Response, and Amendment filed 09/08/2025 is acknowledged.
Applicant has overcome the following rejections by virtue of the amendment or cancellation of the claims: (1) the 35 U.S.C. §112(b) rejections of claims 20-23 and 27 have been withdrawn; (2) the 35 U.S.C. §112(d) rejection of claim 28 has been withdrawn; (3) the 35 U.S.C. §103 rejections of claims 2, 20-21, 23, and 27-28 over Santos and Altman have been withdrawn; (4) the 35 U.S.C. §103 rejections of claims 20 and 28 over Omenetto and Altman have been withdrawn; and (5) the 35 U.S.C. §103 rejection of claim 22 over Omenetto, Altman, and Thakur has been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1, 8-19, 24-26, 29-34
Withdrawn claims: None
Previously cancelled claims: 3-7, 35-39
Newly cancelled claims: 2, 20-23, 27-28
Amended claims: 1, 8-19, 24-26, 29-34
New claims: None
Claims currently under consideration: 1, 8-19, 24-26, 29-34
Currently rejected claims: 1, 8-19, 24-26, 29-34
Allowed claims: None
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/08/2025 has been entered.
Claim Objections
Claims 1, 8-9, 11-12, 14, 16-17, 24-26, and 29-34 are objected to because of the following reasons:
Claims 1, 8-9, 11-12, 14, 16-17, and 24-26 still recite “beverage” in them.
Claims 29-34 are dependent from now-cancelled claim 28. For the purpose of this examination, the claims will be considered as depending from claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 8-14, 18-19, 24-26, and 29-33 are rejected under 35 U.S.C. 103 as being unpatentable over Santos (WO 2019/094700; IDS citation) in view of Altman (US 2015/0094269; previously cited).
Regarding claim 1, Santos teaches a silk food or beverage product (corresponding to silk-based product) comprising a foodstuff and a silk fibroin fragment coating layer comprising silk fibroin fragments on a surface of the foodstuff [0006], [0501], [0506]. It teaches that the silk fibroin fragments are present in the food or beverage product in a concentration of about 0.01 wt.% to about 10 wt.% relative to the total weight of the product [0201], which falls within the claimed concentration. Santos teaches that the silk fibroin fragments have an average molecular weight within the range of about 1 kDa to about 140 kDa [0079], which falls within the claimed range. Santos also teaches that the silk fibroin fragments may also be used in the production of cosmetics and films [0006], [0008], [0607] wherein stability of the silk fibroin is a factor [0051]; and that the silk fibroin is produced from the silkworm species Bombyx mori [0034].
Santos does not teach that the silk fibroin has a polydispersity of 1 to about 5; or that the coating layer has a water content of 2.0 wt.% to about 20. 0 wt.% relative to the total weight of the coating layer.
However, Altman teaches silk fibroin having an average molecular weight of about 6 kDa to about 80 kDa; and a polydispersity of about 1 to about 1.5, about 1.5 to about 2.0, about 2.0 to about 2.5, or about 2.5 to about 3.0 [0005], [0195], which fall within the claimed polydispersity range. Altman discloses that this silk fibroin may be used in films for cosmetics [0009] and is produced by Bombyx mori [0132]. Altman teaches that a final composition comprising the silk fibroin (corresponding to film) has a water content of about 2.0 to about 20 wt.% relative to the weight of the final composition so that the composition will remain stable over time without having yellow discoloration [0009], [0173]. This water content encompasses the claimed water content. It would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "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 percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.I.
It would have been obvious for a person of ordinary skill in the art to have modified the silk fibroin of Santos to have the polydispersity taught by Altman. Since Santos discloses a silk fibroin having an average molecular weight of about 1 kDa to about 140 kDa [0031] being produced from Bombyx mori [0034] and being applied to the production of films for cosmetics [0006], [0607] wherein stability of the silk fibroin is a factor [0051], but does not disclose a polydispersity for such a silk fibroin or a water content for a composition comprising the silk fibroin, a skilled practitioner would have been motivated to consult an additional reference such as Altman in order to determine a suitable polydispersity for the silk fibroin and for producing a stable coating comprising the silk fibroin. Since Santos discloses that its silk fibroin is used in films and cosmetic products as well as food products [0006], [0008], [0568], [0607], [0610], a skilled practitioner would readily recognize that the silk fibroin applied to films and cosmetics recited by Altman may be used in the cosmetics, films, and food products of Santos; therefore, the claimed polydispersity and water content are rendered obvious.
Regarding claim 8, Santos teaches the invention as described above in claim 1, including the silk fibroin fragments are present in the food product in a concentration of about 0.01 wt.% to about 5 wt.% relative to the total weight of the product [0201], which falls within the claimed concentration.
Regarding claim 9, Santos teaches the invention as described above in claim 1, including the silk fibroin fragments are present in the food product in a concentration of about 0.01 wt.% to about 1 wt.% relative to the total weight of the product [0201], which falls within the claimed concentration.
Regarding claim 10, Santos teaches the invention as described above in claim 1, including the product contains 0.5-4 wt.% sericin [0071] and 50 wt.% silk fibroin fragments [0200]. Therefore, it discloses that the product comprises 0.01-0.08 wt.% sericin relative to the total weight of the silk fibroin fragments, which falls within the claimed concentration.
Regarding claim 11, Santos teaches the invention as described above in claim 1, including the product contains 0.5-4 wt.% sericin relative to the total weight of the product [0071], which falls within the claimed concentration.
Regarding claim 12, modified Santos teaches the invention as described above in claim 1, including the silk fibroin fragments do not spontaneously or gradually gelate and do not visibly change color or turbidity when in an aqueous solution for at least 10 days prior to formulation into the food product (Altman [0006], [0142]), which falls within the claimed time frame.
Regarding claim 13, modified Santos teaches the invention as described above in claim 1, including the silk fibroin fragments have a shelf stability of at least 10 days to 3 years (Altman [0142]), which falls within the claimed time frame.
Regarding claim 14, modified Santos teaches the invention as described above in claim 1, including the silk fibroin fragments have a shelf stability of at least 10 days to 3 years when in an aqueous solution for at least 10 days prior to formulation into the food product (Altman [0006], [0142]), which falls within the claimed time frame.
Regarding claim 18, modified Santos teaches the invention as described above in claim 13, including shelf stability is measured at room temperature (Altman [0142]).
Regarding claim 19, modified Santos teaches the invention as described above in claim 13, including the shelf stability is measured at about 21°C to about 23°C (corresponding to room temperature) and 4°C (Altman [0142] and Table 1), which fall within the claimed temperature range.
Regarding claim 24, Santos teaches the invention as described above in claim 1, including the silk food product further comprises an ingredient selected from an emulsifying agent, a thickening agent, a lipid material (corresponding to lipidoids, lipid nanoparticles, lipoplexes), a preservative [0136], a vitamin, a mineral (table on page 343), a sweetening agent, a coloring agent [0013], stabilizer (table on page 344), an antioxidant (corresponding to vitamin e in table on page 343), and a flavoring agent (table on page 61).
Regarding claim 25, Santos teaches the invention as described above in claim 1, including the silk food product is selected from a nutritional supplement [0263], a cereal-based product [0514], a meat, deli meat (corresponding to meat), and a dairy product [0517].
Regarding claim 26, Santos teaches the invention as described above in claim 1, including the silk food product is selected from lettuce, berries (corresponding to blackberry, blueberry, and strawberry), corn, avocado, banana, tomato, peach, potato, bean, kale, broccoli, mushroom, asparagus, grain (corresponding to cereal), parsley [0514], eggs, yogurt, milk [0517], chicken (corresponding to poultry), and fish [0516].
Regarding claims 29, 30, and 31, Santos teaches the invention as described above in claim 1, including the coating is transparent [0210], edible [0506], and/or water soluble [0074].
Regarding claims 32 and 33, Santos teaches the invention as described above in claim 1, including the coating further comprises an additive [0136] selected from antimicrobial agents [0164], antibacterial agents, antifungal agents [0532], hormones, vitamins [0571], a sweetener, a colorings [0013], a flavorings, and perfumes or fragrances [0586].
Claims 1, 15-17, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Omenetto (US 2017/0156356; IDS citation) in view of Altman (US 2015/0094269; previously cited).
Regarding claim 1, Omenetto teaches a silk food product (corresponding to a perishable food item coated with a biopolymer-based coating) [0005] comprising a foodstuff and silk fibroin fragments [0005], [0048], wherein the silk fibroin is produced from Bombyx mori [0051]-[0052]. It teaches that the silk fibroin fragments have an average molecular weight of about 10 kDa, about 15 kDa, about 20 kDa, about 25 kDa, about 30 kDa, about 35 kDa, about 40 kDa, and about 45 kDa [0042], [0045], which fall within the claimed ranges. Omenetto teaches that the coating comprises silk fibroin fragments in an amount of about 0.1-20 wt.% [0092]; that the coating of the product may have any suitable thickness [0101]; and that the coating may partially or fully cover the foodstuff. Therefore, Omenetto at least suggests that the amount of silk fibroin fragments in the product overlaps the claimed concentration. Omenetto teaches the coating prolongs the shelf-life of the food product by maintaining the structural integrity and appearance of the tissues of the food product [0073].
In regards to the overlapping concentration of silk fibroin fragments in the product, it would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "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 percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP §2144.05.I.
Omenetto does not teach that the silk fibroin has a polydispersity of 1 to about 5; or that the coating layer has a water content of 2.0 wt.% to about 20. 0 wt.% relative to the total weight of the coating layer.
However, Altman teaches silk fibroin having an average molecular weight of about 6 kDa to about 80 kDa; and a polydispersity of about 1 to about 1.5, about 1.5 to about 2.0, about 2.0 to about 2.5, or about 2.5 to about 3.0 [0005], [0195], which fall within the claimed polydispersity range. Altman discloses that this silk fibroin may be used in films for cosmetics [0009] and is produced by Bombyx mori [0132]. Altman teaches that a final composition comprising the silk fibroin (corresponding to film) has a water content of about 2.0 to about 20 wt.% relative to the weight of the final composition so that the composition will remain stable over time without having yellow discoloration [0009], [0173]. This water content encompasses the claimed water content. It would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "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 percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.I.
It would have been obvious for a person of ordinary skill in the art to have modified the silk fibroin of Omenetto to have the polydispersity and water content taught by Altman. Since Omenetto discloses a silk fibroin having an average molecular weight of about 10 kDa to about 90 kDa [0042], [0045] being produced from Bombyx mori [0051]-[0052] wherein the coating comprising the silk fibroin is intended to maintain the integrity of the food product during storage [0073], but does not disclose a polydispersity for such a silk fibroin or a water content of the coating comprising the silk fibroin, a skilled practitioner would have been motivated to consult an additional reference such as Altman in order to determine a suitable polydispersity for a silk fibroin fragment having these properties and to determine a suitable water content for a stable composition comprising the silk fibroin; therefore, the claimed polydispersity is rendered obvious.
Regarding claim 15, Omenetto teaches the invention as described above in claim 1, including the foodstuff has a shelf stability of at least 24 hours (corresponding to the control strawberry having a similar water content on day 1 as it did when it was received as shown in Fig. 3), which falls within the claimed time frame.
Regarding claim 16, Omenetto teaches the invention as described above in claim 1, including the silk food product has a shelf stability of at least 1 hour [0076], which falls within the claimed time frame.
Regarding claim 17, Omenetto teaches the invention as described above in claim 1, including the silk food product has a shelf stability longer than the shelf stability of the corresponding foodstuff not formulated into the silk food product [0081].
Regarding claim 34, Omenetto teaches the invention as described above in claim 1, including the coating not containing an added plasticizing agent [0042], [0062].
Response to Arguments
Claim Rejections – 35 U.S.C. §112(b) of claims 20-23 and 27: Applicant canceled the claims; therefore, the rejections are withdrawn.
Claim Rejections – 35 U.S.C. §112(d) of claim 28: Applicant canceled the claim; therefore, the rejection is withdrawn.
Claim Rejections – 35 U.S.C. §103 of claims 1-2, 8-14, 18-21, and 23-33 over Santos and Altman: Applicant’s arguments and claim amendments have been fully considered and are not considered to overcome the prior art rejections.
Applicant canceled claims 2, 20-21, 23, and 27-28. Applicant amended claim 1 to recite that the coating layer has a water content of 2.0 wt.% to about 20.0 wt.% relative to the total weight of the coating layer. Applicant stated that the water content of the coating layer affects the blocking resistance and flexibility of the coating layer and the water content is adjusted to obtain the desired film properties. Applicant argued that Santos and Altman do not disclose the claimed water content (Applicant’s Remarks, page 6, 5th paragraph – page 7, 1st paragraph).
However, in the rejection of amended claim 1 written above, Altman is described as disclosing that a film comprising the silk fibroin has a water content of about 2.0 to about 20 wt.% relative to the weight of the final composition so that the composition will remain stable over time without having yellow discoloration [0009], [0173]. This water content encompasses the claimed water content, thereby rendering the claimed water content obvious. The Examiner also points out that the Applicant disclosed water content of the coating layer as being a result-effective variable (Applicant’s Remarks, page 6, 7th paragraph), which also renders the claimed water content obvious, especially wherein the present specification does not demonstrate criticality of the claimed water content of the coating layer. Since the prior art has been shown to render claims 1, 8-14, 18-21, and 23-33 obvious and Applicant’s arguments have been shown to be unpersuasive, the rejections of claims 1, 8-14, 18-21, and 23-33 are maintained as written herein. The rejections of claims 2, 20-21, 23, and 27-28 are withdrawn due to cancelation of the claims.
Claim Rejections – 35 U.S.C. §103 of claims 1, 15-17, 20, 28, and 34 over Omenetto and Altman: Applicant’s arguments and claim amendments have been fully considered and are not considered to overcome the prior art rejections.
Applicant canceled claim 20 and 28. Applicant amended claim 1 to incorporate the features of now-canceled claim 2. Applicant argued that claim 2 was not rejected over the combination of Omenetto and Altman in the previous Office Action (Applicant’s Remarks, page 7, 2nd-3rd paragraphs).
However, amended claim 1 is shown to be rendered obvious by the combination of Omenetto and Altman as described in the rejection above. Since the prior art has been shown to render the amended claim obvious and Applicant’s arguments have been shown to be unpersuasive, the rejections of claims 1, 15-17, and 34 are maintained as written herein. The rejections of claims 20 and 28 are withdrawn due to the cancelation of the claims.
Claim Rejections – 35 U.S.C. §103 of claim 22 over Omenetto, Altman, and Thakur: The cancelation of the claim renders its rejection moot.
Applicant canceled claim 22 (Applicant’s Remarks, page 7, 4th-5th paragraphs).
The rejection of claim 22 is withdrawn due to the cancelation of the claim.
Conclusion
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/KELLY P KERSHAW/Examiner, Art Unit 1791