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 September 12, 2023, has been entered. Claims 3, 5 – 7, 21 – 46, and 48 – 50 have been cancelled. Claims 8 – 20 and 47 have been amended and claims 51 and 52 have been added. Therefore, the pending claims are 1, 2, 4, 8 – 20, 47, 51, and 52.
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, 4, 8 – 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.
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 1 recites the broad recitation “at least one mechanical property that is at least 50% greater than a reference mechanical property of the silk fibroin article core in an absence of the biodegradable hydrophobic polymer layer”, and the claim also recites “wherein the at least one mechanical property includes a three-point bending flexural strain” 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. Hence it is unclear if one of any mechanical property being 50% greater is sufficient to read on the claim. Or does the claim require that the mechanical property that it 50% greater is a three-point bending flexural strain? Or does the claim require that the prior art needs to have the 50% greater three-point bending flexural strain and a second mechanical property that is 50% greater. Claims 2, 8 – 17, 19, 20, 47, 51, and 52 are rejected due to their dependency on claim 1.
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. Claims 2, 8 – 17, 19, 20, 47, 51, and 52 are rejected due to their dependency on claim 1.
The term “water uptake” in claim 1 is indefinite. While the applicant discusses the water uptake property in the disclosure, the applicant fails to teach how the water uptake is measured. Is this property equivalent to moisture regain or water absorption? Or is it different? How does the applicant measure “water uptake”?
The phrase “induces fusion between at least a portion of the silk fibroin material and structural change of fibroin in the silk fibroin material” in claim 4 is indefinite. The disclosure states that the fusion refers to a process of combining two or more distinct entities into a new whole (Specification, Paragraph 21). It is unclear what the two or more distinct entities are being fused in claim 4. It seems that the first article is a portion of the silk fibroin material. However, it is unclear if a second article separate from the silk fibroin material is being fused with the silk fibroin or if the fusion is between multiple portions of silk fibroin materials and that fusion results in structural change of the silk fibroin material into the silk fibroin article. As set forth below, the silk fibroin article is considered to be distinct from the silk fibroin material because the silk fibroin article has a degree of crystallinity after fusing occurs and is no longer a substantially amorphous structure. Claims 18 is rejected due to its dependency on claim 4.
The phrase “the biodegradable hydrophobic polymer layer comprising aliphatic polyesters; selected from the group consisting of polylactide, polycaprolactone, and polycarbonate, aromatic and aliphatic polyanhidrides, polyurethanes, polyamides, poly(ester amide), or a copolymer or combination thereof” in claim 8 is indefinite. The claim limits the biodegradable hydrophobic polymer to an aliphatic polyester, but then states that the aliphatic polyesters are selected from a group that includes polymers that are not aliphatic polyesters. For instance, polylactide and polycaprolactone are known biodegradable hydrophobic aliphatic polyesters. However, while polycarbonate is a type of polyester, the material is not known to be biodegradable. Further, aromatic and aliphatic polyanhydrides, polyurethanes, polyamides, and polyester amides are not types of aliphatic polyesters. Therefore, it not clear how the coating can be chosen from some of these materials? Or can the coating include non-polyester and non-biodegradable materials?
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 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 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.
Definition of Terms
The term “substantially” in claim 1 is interpreted as requiring total or as near total covering of the silk fibroin article core except for a potential lack of completeness which might result due to the biological and chemical nature of the product (Specification, Paragraph 32).
The term “ silk fibroin article” is considered to be distinct from the substantially amorphous structure of a silk fibroin, and have some degree of desired crystallinity and desired material properties (Specification, Paragraph 35).
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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) 1, 2, 8, 9, 13, 16, 51, and 52 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Altman et al. (WO 2004/080346).
Altman et al. discloses a silk fiber based medical device comprising a construct of silk fibroin fibers having excellent tensile strength and mechanical properties (abstract). Articles are formed from fabrics comprising silk fibroin fiber (paragraph 88). The silk fibroin fabrics can be modified in several different ways including surface modification through peptide coupling or gas plasma irradiation (paragraph 92). The silk materials can be coated with different polymers (paragraph 95). The fiber construct can include a silk component and biodegradable polymers such as polylactide, polycaprolactone, polyamides, polyanhydrides, degradable polyurethanes, etc. (paragraph 134). The fiber construct can be treated to enhance the structure by irradiation, chemical surface modifications, peptide coating, and physical surface modifications (paragraph 135). Proteases can be used in the peripheral encapsulation (paragraph 15). Further, the materials can be treated with a heat treatment to bond crossover points (paragraph 99). Further, Altman et al. discloses that the silk fiber based construct can be designed to possess specific mechanical properties such as increased tensile strength (paragraph 137).
Although Altman et al. does not explicitly teach the limitations 50% greater mechanical properties, improved three-point bending flexural strain, or 50% lower water uptake 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. using a silk fibroin based article which is treated using heat or irradiation) and in the similar production steps (i.e. applying a hydrophobic coating to the construct) used to produce the silk construct. The burden is upon the Applicant to prove otherwise. In re Fitzgerald, 205 USPQ 594. In the alternative, the claimed properties would obviously have been provided by the process disclosed by Altman 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, 2, 8, 9, 13, 16, 51, and 52 are rejected.
Claim Rejections - 35 USC § 103
Claim(s) 4, 10 – 12, 14, 15, 17 – 20, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Altman et al. in view of Kaplan et al. (WO 2020/117368).
The features of Altman et al. have been set forth above. While Altman et al. discloses constructs made from silk fibroin that is mechanically treated, Altman et al. fails to teach treating the silk fibroin to produce between fusing the silk fibroin to create a silk fibroin article core. Kaplan et al. is drawn to treating silk fibroin. Kaplan et al. discloses that the treating process produces a silk material with properties comparable or even superior to other silk products (paragraph 4). The silk product is produced by including the steps of (i) providing silk fibroin material comprising substantially amorphous structure, and (ii) applying at least one of elevated temperature and elevated pressure to the silk fibroin material to form a silk fibroin article, wherein the applying induces fusion between at least a portion of the silk fibroin and structural change of fibroin in the silk fibroin material and the silk material is transformed into a solid silk article that has undergone a silk conformational change that includes at least some of the silk fibroin being fused together (paragraph 5). The material can be used to make different shape materials including packaging (paragraph 7). The product has a density of at least 1.20 g/cm3 (paragraph 7). Further, examples includes flexural strength of over 50Mpa (paragraphs 31 – 32).
Thus, it would have been obvious to one having ordinary skill in the art to modify the silk fibroin structure as taught by Kaplan et al. in the product of Altman et al. since silk fibroin of Kaplan et al. has improved properties. Thus, claims 4, 17, 18, 19, and 47.
Further, with regard to the amount of hydrophobic coating and the thickness of the coating, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a substantial amount of coating at a uniform and sufficient thickness to provide beneficial properties to coated materials, 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 – 12 are rejected.
Further, Kaplan discloses that it is known to use enzymes such as protease in the article to provide benefits during use. Thus, it would have been obvious to choose from known enzyme materials like protease to add to the silk fibroin article to improve the biological properties of the silk fibroin article. Thus, claims 14 and 15 are rejected.
Finally, it would have been obvious to one having ordinary skill to have at least 10% by weight of silk material in the coated silk article disclosed by Altman et al. in view of Kaplan et al. Thus, claim 20 is rejected.
Conclusion
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jlj
March 4, 2026
/JENNA L JOHNSON/Primary Examiner, Art Unit 1789