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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 2 recites that the coagulation liquid (previously recited in Claim 1 to contain water) further contains an aqueous solution. This “further” makes it sound like the water from Claim 1 and the aqueous solution from Claim 2 are supposed to be two distinct and separate phases, an idea for which there is no support in the specification, which describes the water in the coagulation liquid as being an aqueous solution when salts are added.
Claim 3 repeats the framing of the water and the aqueous solution as two distinct and separate phases by reciting them as linked by “and.”
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 2-5 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 2, it is unclear how the coagulation liquid would further contain an aqueous solution in addition to the water. For the purposes of examination, Claim 2 will be presumed to read --wherein the water contained in the coagulation liquid
Regarding Claim 3, it is unclear how the water and the aqueous solutions would be two independent claim elements. For the purposes of examination, Claim 3 will be presumed to read --wherein a content of
Claim Rejections - 35 USC § 102
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.
Claims 1-6, 11, and 13-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Breslauer et al. (US 2018/0111970 A1, hereinafter Breslauer).
Regarding Claims 1 and 11, Breslauer teaches in [0092]-[0105] a method for producing an artificial structural protein fiber by a wet spinning method, the method comprising:
a coagulation step of discharging a spinning dope containing an artificial structural protein and an organic solvent (recombinant polypeptide powder in formic acid per [0092]) from a spinneret (per [0098]) into a coagulation liquid stored in a coagulation batch to coagulate the artificial structural protein (per [0099]-[0101]), and drawing the coagulated artificial structural protein fiber in the coagulation bath to reduce a diameter of the artificial structural protein fiber (per [0103]-[0105], since drawing reduces fiber diameter),
wherein a bath draft in the coagulation step is from 0.7 to 20, wherein the bath draft is a value obtained by dividing speed at which a coagulated yarn is taken up by a take-up roller by a linear velocity at which the spinning dope is discharged from the spinneret (per [0103]) wherein the drawing rate is the bath draft as defined in [0163] and wherein the reel rate is understood to be the linear velocity at which the spinning dope is discharged from the spinneret since the reel rate is not referred to as a drawing step, which thus implies since there is no intended drawing that the reel rate matches the linear velocity at which the spinning dope is discharged, or is at least sufficiently close that that at least some (likely all) of the disclosed drawing rates of 1.5x – 15x (per [0103]-[0105]) fall within the bath draft claimed range of 0.7 to 20),
wherein the coagulation liquid contains water, and wherein a content of the water relative to a total amount of the coagulation liquid is 50% by mass or more (per [0100], wherein the 50:50 by volume methanol:water coagulation liquid is approximately 56% water by mass, based on the density of methanol being 0.792 g/mL and water density being 1 g/mL). Alternatively, since the methanol and other coagulation bath additives are listed as optional, in those cases the water content of the coagulation liquid would be 100% by mass.
Regarding Claims 2-5, Breslauer teaches an embodiment of the coagulation liquid has sodium sulfate as an additive, which, as evidenced by Applicant’s disclosed sodium sulfate solutions, would result in sodium sulfate aqueous solution have a pH between 0.25 and 10 and in the case without methanol be an aqueous solution of 100% by mass of the coagulation liquid.
Regarding Claim 6, Breslauer teaches in [0111] that the protein content of in the spinning dope is 20-50% by weight.
Regarding Claims 13-18, [0105] discloses a draw ratio of 1.5.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Breslauer as applied to Claim 1 above.
Regarding Claim 12, Breslauer teaches in [0107] that the coagulation liquid contains formic acid, but is silent on how much formic acid should be in coagulation baths containing 50% or more water by mass. Nonetheless, a value would have to be chosen if following that instruction, and Breslauer has indicated in [0117] that in a separate embodiment, 20% formic acid in the coagulation bath is an appropriate amount to help the coagulation bath remain appreciably constant. Therefore, it would have been obvious to a person having ordinary skill in the art prior to the invention’s filing to use the formic acid organic solvent in the amount of 10-30% by mass of a total amount of the coagulation liquid in order to help maintain appreciably constant conditions.
Regarding Claim 20, Breslauer teaches in [0110] that the spinneret has a hole diameter from 0.025 mm to 0.2 mm, but is silent on a specific embodiment having a hole diameter from 0.04 mm to 0.1 mm in combination with a coagulation bath having 50% or more water by mass. Breslauer does teach spinning with a 50 micron (0.05 mm) spinneret hole in [0163] is known however, and thus it would have been obvious to use such a spinneret hole diameter as claimed since it is a known spinneret diameter that could be used to achieve the predictable result of spinning fiber.
Claims 7-10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Breslauer as applied to Claim 1 above, and in view of Islam et al. (US 2004/0102614 A1, hereinafter Islam).
Regarding Claims 7-10 and 19, Breslauer teaches the method as applied above, but is silent on hydropathy of the protein as well as its status as a spider silk protein.
In analogous art pertaining to spinning, Islam teaches a method for producing an artificial structural protein fiber via spinneret (per [0007]) by a wet spinning method (per [0006]), the method comprising a coagulation step of discharging a spinning dope containing an artificial structural protein (“synthetic biofilament proteins” for instance, per [0008]) and an organic solvent (per [0009] disclosing embodiments with as much as 20% of an organic solvent by volume) from the spinneret into a coagulation liquid/bath to coagulate the artificial structural protein (per [0014]).
Islam further teaches in [0006]-[0008] and [0125] that it is known in such a system to make the artificial structural protein a modified spider skill fibroin, and in [0084] that the method can use synthetic biofilament proteins such as collagen.
Therefore, it would have been obvious to use Islam’s known spider silk or collagen proteins in Breslauer’s spinning method, since it would be a simple substation of one known protein for another to yield the predictable result of fiber spinning.
Furthermore, spider silk protein is the main protein of interest in the instant invention and thus Islam’s spider silk is presumed to meet the claimed condition of the artificial structural protein’s average hydropathy index being more than -0.8 since it has been held that where the claimed and prior art products are identical or substantially identical in structure or are produced by identical or a substantially identical processes, a prima facie case of either anticipation or obviousness will be considered to have been established over functional limitations that stem from the claimed structure. In re Best, 195 USPQ 430, 433 (CCPA 1977), In re Spada, 15 USPQ2d 1655, 1658 ( Fed. Cir. 1990). The prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed products. in re Best, 195 USPQ 430, 433 (CCPA 1977).
Response to Arguments
Applicant’s arguments with respect to Claims 1-20 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Johansson et al. (US 2012/0041177 A1) teaches criticality of pH in spider silk production.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN M OCHYLSKI whose telephone number is (571)270-7009. The examiner can normally be reached Monday-Friday 9-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Galen Hauth can be reached at (571) 270-5516. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RYAN M OCHYLSKI/Primary Examiner, Art Unit 1743
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