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 .
Response to Amendment
The Amendment submitted on June 12, 2026, has been entered. Claims 3, 5 – 7, 21 – 46, and 48 – 50 have been cancelled. Claims 1, 4, and 52 have been amended and no claims have been added. Therefore, the pending claims are 1, 2, 4, 8 – 20, 47, and 51 – 52.
The 35 USC 112 rejection with regards to the broad range and narrow range lamination in the claim 1 is withdrawn since claim 1 has been amended to remove the different ranges.
The amendment to claim 4 is sufficient to overcome the 35 USC 112 rejection set forth in section 8 of the previous Office Action.
The 35 USC 102/103 rejection over Altman et al. is withdrawn since Altman et al. clear about that the structure of the fiber construct comprising silk and biodegradable polymers would include silk fibroin with the sericin removed.
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 1, 2, 8 – 17, 19 – 20, 47, 51, and 52 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.
The term “three-point bending flexural strain” in claim 1 is indefinite. It is unclear what test method the applicant is using to determine the “three-point bending flexural strain”. The scope of the testing cannot be understood without knowing the test method used to determine the results.
The applicant argues (response, page 6) that the three-point bending test is well known in the art. However, the three-point bending test has different procedures for different materials, including plastic, metal, and composites. The different tests include ASTM D790, ASTM D7264, ISO 178, or ISO 14125, which are directed to specific types of products, shaped into a specific sized article that is placed on the bending apparatus. Additionally, the claim is to a coated silk fibroin article, and the disclosure states that the article can include products such as films, fibers, meshes, needles, tubes, plates, screws, rods, and any combination thereof. It is not clear how one of these bending tests is done on fiber and meshes or that there is a bending test for fibers or fabrics. Further, if the silk fibroin article is formed into a tube or screw is the bending test done on a bar of the composite material? If so, is the claim only to the bar of composite material or is the shaped article the final product? Applicant fails to address how the claimed bending test is applied to the generic silk fibroin article. Claims 2, 8 – 17, 19, 20, 47, 51, and 52 are rejected due to their dependency on claim 1.
The phrase “the biodegradable hydrophobic polymer layer comprising aliphatic polyesters; selected from the group consisting of polylactide, polycaprolactone, and polycarbonate, an aromatic and aliphatic polyanhidrides, polyurethanes, polyamides, poly(ester amide), or a copolymer or combination thereof” in claim 8 is indefinite. The applicant argues that the use of the oxford comma is proper for a list (response, page 6 – 7). However, the claim doesn’t include a simple list of three elements, but a list of different groups where one is a Markush group and the others are not. The continued use of commas and not a semi-colon to denote the end of the Markush and the separates groups within the list make the claim unclear. Further, it is not clear if the fact that one group is a Markush means that at least one polymer from the Markush group must be chosen. Why is the Markush group only related to the polyesters and the other groups are not part of a Markush group. Also, the use of “and” between an aromatic and aliphatic polyanhydride suggests that the item is both aromatic and aliphatic. Examiner suggests that applicant either lists all items as a Markush group or list all items separately. Further, polyanhydride is misspelled. Also, the applicant cited a reference to show that biodegradable polycarbonate materials were known in the art. However, the applicant fails to provide the reference. Thus, it is unclear that biodegradable bicarbonate polymers were known in the art at the time of the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 16 recites the broad recitation having a flexural strength of at least 50 Mpa, and the claim also recites at least 100 MPa, or at least 150 MPa, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. The response did not address the rejection.
The term “flexural strength” in claim 16 is indefinite. It is unclear how the flexural strength is measured. Further, it is unclear if this is the same as flexural strain referenced in claim 1 or if this is different property being measured using a different testing method. The response did not address this rejection.
The phrase “the silk fibroin article core comprises silk in an amount of about 10% or higher” in claim 20 is indefinite. It is unclear what type of silk is required to be present in 10% or more. The crystalline silk structure, the amorphous silk structure, or non-modified silk fibers? What type of silk is required to be present in 10% or more. Any type of silk-based material is considered to read on general silk within the article. The response did not address this rejection.
The “water uptake” in claim 52 is indefinite. The claim recites that the water uptake is measured by submerging in aqueous solution for a predetermined length of time. However, neither the claim nor the disclosure details the specific amount of time or water aqueous solutions are required to be use. If the test is not done consistently then comparison might be less than 50% for a first time or solution and greater than 50% for a different time or solution without changing the silk fibroin article. The exact test procedure needs to be defined by the applicant so that the testing is repeatable and one of ordinary skill in the art would know if the sample has the claimed property or not. The disclosure has not detailed the exact test procedure applicant is using to measure water uptake.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 4 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lo et al. (US 2015/0183841).
Lo et al. discloses silk based products that are mechanically strong with tunable degradation properties (abstract). Lo et al. discloses that sericin removed silk fibroin products can be produced by temperatures of about 90ºC (paragraph 7). This is considered to meet the requirement for elevated temperature since this temperature is above room temperature or colder temperatures. Further, the silk fibroin composition can produce a silk fibroin article such as a film, a sheet, a gel or hydrogel, a mesh, a mat, a non-woven mat, a fabric, a scaffold, a tube, a slab or block, a fiber, a particle, powder, a 3-dimensional construct, an implant, a foam or a sponge, a needle, a lyophilized article, and any combinations thereof (paragraph 9). In some embodiments, the solid-state silk fibroin can comprise one or more biocompatible polymers in a total concentration of about 0.1 wt % to about 70 wt %, about 1 wt % to about 60 wt %, about 10 wt % to about 50 wt %, about 15 wt % to about 45 wt % or about 20 wt % to about 40 wt % (Paragraph 114). Further, the biocompatible polymers can be coated on a surface of the solid-state silk fibroin or silk fibroin article (Paragraph 114). Examples of the biocompatible polymers can include hydrophobic materials such as biodegradable polymers, chosen from polycaprolactone, polylactic acid, polyanhydrides, PLA-PGA, other biocompatible and/or biodegradable polymers and any combinations thereof (paragraph 115). Thus claim 4 is anticipated.
Further, Lo et al. teaches that the silk product can be modified by undergoing conformational change (paragraph 21). The alteration can occur by applying shear stress or applying pressure to the silk fibroin product (paragraph 160). Thus, claim 18 is anticipated.
Claim Rejections - 35 USC § 102/103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2, 8, 9, 12, 16, 19, 20, 47, 51, and 52 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Lo et al. (US 2015/0183841).
The features of Lo et al. have been set forth above. Lo et al. teaches that the modified silk fibroin material has enhanced mechanical properties (paragraph 7). Although Lo et al. does not explicitly teach the limitations of three-point bending flexural strain, water uptake, flexural strength, or a comparison of mechanical properties of silk fibroin with additives to silk fibroins without the additive, it is reasonable to presume that said limitations are inherent to the invention. Support for said presumption is found in the use of similar materials (i.e. silk-fibroin material with biodegradable additives) and in the similar production steps (i.e. the biodegradable additive can be a hydrophobic additive which can be coated onto the silk fibroin) used to produce the various end products, such as films, fibers, textiles, meshes, composites, and implants. The burden is upon the Applicant to prove otherwise. In re Fitzgerald, 205 USPQ 594. In the alternative, the claimed improved properties would obviously have been provided by the process disclosed by Lo et al. Note In re Best, 195 USPQ 433, footnote 4 (CCPA 1977) as to the providing of this rejection under 35 USC 103 in addition to the rejection made above under 35 USC 102. Thus, claims 1, 8, 9, 16, 51, and 52 are rejected.
As set forth above, the silk fibroin material is produced by heating at temperatures of about 90ºC (paragraph 7). Thus, claim 2 is rejected.
Further, the silk fibroin article includes 1 to 70% by weight of the article (paragraph 114). Thus, claim 12 is rejected.
The biocompatible polymer is coated on the silk fibroin article (paragraph 114). This would result in the core being a homogenous silk fibroin material with a coating layer on the outer surface of the article. Thus, claim 19 is rejected.
The silk fibroin article can include at least 9% w/w or more of higher molecular weight silk fibroin. Thus, claim 20 is rejected.
With regards to claim 47, using the fibroin article as at least a portion of packaging material, Lo et al. discloses that the silk fibroin article a film, a sheet, a gel or hydrogel, a mesh, a mat, a non-woven mat, a fabric, a scaffold, a tube, a slab or block, a fiber, a particle, powder, a 3-dimensional construct, an implant, a foam or a sponge, a needle, a lyophilized article, and any combinations thereof (paragraph 9). These materials can be used in packaging material. Further, it has been held that a recitation with respect to the manner in which a claimed product is intended to be employed does not differentiate the claimed product from a prior art product satisfying the claimed structural limitation. Ex parte Masham, 2 USPQ2d 1647 (1987). Thus, claims 47 is rejected.
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.
Claim(s) 10, 11, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lo et al.
Lo et al. discloses a coating can be added to the silk fibroin article (paragraph 114). While Lo et al. fails to teach specific details about the thickness or uniformity of the coating it would have been obvious to one having ordinary skill to choose a uniform coating the is of a consistent thickness to provide the coating properties uniformly around the entire silk fibroin article. Further, one of ordinary skill in the art would understand the amount of coating needed to protect and modify the properties of the silk fibroin article. Lo et al. discloses that the disclosure is designed to allow to produce silk fibroin products that are strong with tunable degradation properties. Thus, Lo et al. acknowledges that it would be reasonable for one of ordinary skill in the art would to choose and fine tune properties with without undue experimentation. It would have been obvious to one having ordinary skill in the art at the time the invention was made to choose a thickness of 1 micron to 5 microns, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 105 USPQ 233 (CCPA 1955). Thus, claims 10 and 11 are rejected.
Further, one of ordinary skill in the art at the time the invention was made to choose a core having a density of at least 1.20 g/cm3 since choosing density of the silk fibroin material allows one to optimize mechanical properties of the composite. Thus, claim 17 is rejected.
Allowable Subject Matter
Claims 13 – 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art fails to teach or fairly suggest a coated silk fibroin article comprising a silk fibroin article core, a biodegradable hydrophobic polymer coating with the three-point bending flexural strain as recited in claim 1, wherein the silk fibroin article core and/or the biodegradable hydrophobic coating comprises an acid-activated protease. The prior art only teaches using protease materials with regards to breaking down the silk cocoon and not as part of the silk fibroin article or the hydrophobic coating.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 Jenna Johnson whose telephone number is (571)272-1472. The examiner can normally be reached Monday, Wednesday, and Thursday, 10am - 4pm.
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jlj
September 2, 2026
/JENNA L JOHNSON/Primary Examiner, Art Unit 1789
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